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Sample records for event reporting system

  1. Revised licensee event report system

    International Nuclear Information System (INIS)

    Mays, G.T.; Poore, W.P.

    1985-01-01

    Licensee Event Reports (LERs) provide the basis for evaluating and assessing operating experience information from nuclear power plants. The reporting requirements for submitting LERs to the Nuclear Regulatory Commission have been revised. Effective Jan. 1, 1984, all events were to be submitted in accordance with 10 CFR 50.73 of the Code of Federal Regulations. Report NUREG-1022, Licensee Event Report System-Description of System and Guidelines for Reporting, describes the guidelines on reportability of events. This article summarizes the reporting requirements as presented in NUREG-1022, high-lights differences in data reported between the revised and previous LER systems, and presents results from a preliminary assessment of LERs submitted under the revised LER reporting system

  2. Adverse Event Reporting System (AERS)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all...

  3. CDC Wonder Vaccine Adverse Event Reporting System

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Vaccine Adverse Event Reporting System (VAERS) online database on CDC WONDER provides counts and percentages of adverse event case reports after vaccination,...

  4. CDC WONDER: Vaccine Adverse Event Reporting System (VAERS)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Vaccine Adverse Event Reporting System (VAERS) online database on CDC WONDER provides counts and percentages of adverse event case reports after vaccination, by...

  5. FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files

    Data.gov (United States)

    U.S. Department of Health & Human Services — The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database...

  6. 10 CFR 50.73 - Licensee event report system.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Licensee event report system. 50.73 Section 50.73 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES Inspections... systems, including: emergency diesel generators (EDGs); hydroelectric facilities used in lieu of EDGs at...

  7. Classification system for reporting events involving human malfunctions

    International Nuclear Information System (INIS)

    Rasmussen, J.; Pedersen, O.M.; Mancini, G.

    1981-01-01

    The report describes a set of categories for reporting industrial incidents and events involving human malfunction. The classification system aims at ensuring information adequate for improvement of human work situations and man-machine interface systems and for attempts to quantify ''human error'' rates. The classification system has a multifacetted non-hierarchical structure and its compatibility with Ispra's ERDS classification is described. The collection of the information in general and for quantification purposes are discussed. 24 categories, 12 of which being human factors-oriented, are listed with their respective subcategories, and comments are given. Underlying models of human data process and their typical malfuntions and of a human decision sequence are described. The work reported is a joint contribution to the CSNI Group of Experts on Human Error Data and Assessment

  8. Classification system for reporting events involving human malfunctions

    International Nuclear Information System (INIS)

    Rasmussen, J.; Pedersen, O.M.; Mancini, G.; Carnino, A.; Griffon, M.; Gagnolet, P.

    1981-03-01

    The report describes a set of categories for reporting industrial incidents and events involving human malfunction. The classification system aims at ensuring information adequate for improvement of human work situations and man-machine interface systems and for attempts to quantify ''human error'' rates. The classification system has a multifacetted non-hierarchial structure and its compatibility with Ispra's ERDS classification is described. The collection of the information in general and for quantification purposes are discussed. 24 categories, 12 of which being human factors oriented, are listed with their respective subcategories, and comments are given. Underlying models of human data processes and their typical malfunctions and of a human decision sequence are described. (author)

  9. Classification system for reporting events involving human malfunctions

    DEFF Research Database (Denmark)

    Rasmussen, Jens; Pedersen, O.M.; Mancini, G.

    1981-01-01

    The report describes a set of categories for reporting indus-trial incidents and events involving human malfunction. The classification system aims at ensuring information adequate for improvement of human work situations and man-machine interface systems and for attempts to quantify "human error......" rates. The classification system has a multifacetted non-hierarchical struc-ture and its compatibility with Isprals ERDS classification is described. The collection of the information in general and for quantification purposes are discussed. 24 categories, 12 of which being human factors oriented......, are listed with their respective subcategories, and comments are given. Underlying models of human data processes and their typical malfunc-tions and of a human decision sequence are described....

  10. Licensee Event Report system: description of system and guidelines for reporting

    International Nuclear Information System (INIS)

    Hebdon, F.J.

    1983-09-01

    On July 26, 1983, the Commission published in the Federal Register a final rule (10 CFR 50.73) that modifies and codifies the Licensee Event Report (LER) system. The rule becomes effective on January 1, 1984. This NUREG provides supporting information and guidance that will be of interest to persons responsible for the preparation and review of LERs. The information contained in this NUREG includes: (1) a brief description of how LERs are analyzed by the NRC; (2) a restatement of the guidance contained in the Statement of Consideration that accompanied the publication of the LER rule; (3) a set of examples of potentially reportable events with staff comments on the actual reportability of each event; (4) guidance on how to prepare an LER, including the LER forms; and (5) guidance on submittal of LERs

  11. Systems for reporting unusual events in nuclear power plants

    International Nuclear Information System (INIS)

    1989-01-01

    Many Member States with nuclear power programmes have established, and are operating, systems for collecting, assessing and disseminating information on safety related events in nuclear power plants. The Agency has recognized the importance of such systems and of achieving compatibility between them. It also recognizes the advantage to be derived from international efforts to exchange operational experience on a worldwide basis. In response to requests put forward during the Special Session of the IAEA General Conference held in September 1986, and to the recommendations made by the International Nuclear Safety Advisory Group (INSAG) to strengthen international co-operation in nuclear safety and the exchange of information on operating experience, the IAEA has been following a two-step approach. Firstly, it continues to assist Member States to establish, improve or harmonize their national systems for collecting, assessing and disseminating safety related operational experience, and secondly, it continues to reinforce the IAEA system for reporting unusual events with safety significance (IAEA Incident Reporting System - IAEA-IRS). Although the prime objective of both activities is to assist regulatory bodies and operating organizations to improve operational safety, operating organizations may also benefit if a similar approach is used to improve equipment reliability and plant availability. The present Guide contains a recommended scheme based on national and international practice applicable to the management of safety related operational experience in nuclear power plants. The user will have to adapt this guidance for specific national conditions and practices. It is important to realize however that for an effective exchange of information through the IAEA-IRS it is a prerequisite to follow the procedures given in the relevant part of this Guide

  12. Licensee Event Report system. Description of system and guidelines for reporting. Suppl. 1

    International Nuclear Information System (INIS)

    1984-02-01

    On July 26, 1983, the Commission published in the Federal Register a final rule (10 CFR 50.73) that modified and codified the Licensee Event Report (LER) system. The rule became effective on January 1, 1984. In September 1983, the NRC published NUREG-1022 which provides supporting information and guidance that is of interest to persons responsible for the preparation and review of LERs. The information contained in NUREG-1022 includes: (1) a brief description of how LERs are analyzed by the NRC, (2) a restatement of the guidance contained in the Statement of Consideration that accompanied the publication of the LER rule, (3) a set of examples of potentially reportable events with staff comments on the actual reportability of each event, (4) guidance on how to prepare an LER, including the LER forms, and (5) guidance on submittal of LERs. Subsequently, during the period from October 25, 1983 to November 16, 1983, the NRC staff held five regional meetings to discuss the scope and content of the LER rule with utility and NRC regional representatives. During these meetings numerous questions arose and were answered. This supplement to NUREG-1022 contains a summary of the questions asked and the answers given

  13. Operating Experience from Events Reported to the IAEA Incident Reporting System for Research Reactors

    International Nuclear Information System (INIS)

    2015-03-01

    Operating experience feedback is an effective mechanism in providing lessons learned from events and the associated corrective actions to prevent them, helping to improve safety at nuclear installations. The Incident Reporting System for Research Reactors (IRSRR), which is operated by the IAEA, is an important tool for international exchange of operating experience feedback for research reactors. The IRSRR reports contain information on events of safety significance with their root causes and lessons learned which help in reducing the occurrence of similar events at research reactors. To improve the effectiveness of the system, it is essential that national organizations demonstrate an appropriate interest for the timely reporting of events important to safety and share the information in the IRSRR database. At their biennial technical meetings, the IRSRR national coordinators recommended collecting the operating experience from the events reported to the IRSRR and disseminating it in an IAEA publication. This publication highlights the root causes, safety significance, lessons learned, corrective actions and the causal factors for the events reported to the IRSRR up to September 2014. The publication also contains relevant summary information on research reactor events from sources other than the IRSRR, operating experience feedback from the International Reporting System for Operating Experience considered relevant to research reactors, and a description of the elements of an operating experience programme as established by the IAEA safety standards. This publication will be of use to research reactor operating organizations, regulators and designers, and any other organizations or individuals involved in the safety of research reactors

  14. A new safety event reporting system improves physician reporting in the surgical intensive care unit.

    Science.gov (United States)

    Schuerer, Douglas J E; Nast, Patricia A; Harris, Carolyn B; Krauss, Melissa J; Jones, Rebecca M; Boyle, Walter A; Buchman, Timothy G; Coopersmith, Craig M; Dunagan, W Claiborne; Fraser, Victoria J

    2006-06-01

    Medical errors are common, and physicians have notably been poor medical error reporters. In the SICU, reporting was generally poor and reporting by physicians was virtually nonexistent. This study was designed to observe changes in error reporting in an SICU when a new card-based system (SAFE) was introduced. Before implementation of the SAFE reporting system, education was given to all SICU healthcare providers. The SAFE system was introduced into the SICU for a 9-month period from March 2003 through November 2003, to replace an underused online system. Data were collected from the SAFE card reports and the online reporting systems during introduction, removal, and reimplementation of these cards. Reporting rates were calculated as number of reported events per 1,000 patient days. Reporting rates increased from 19 to 51 reports per 1,000 patient days after the SAFE cards were introduced into the ICU (preporting increased most, rising from 0.3 to 5.8 reports per 1,000 patient days; nursing reporting also increased from 18 to 39 reports per 1,000 patient days (both preporting declined to 0 reports per 1,000 patient days (p=0.01) and rose to 8.1 (p=0.001) when the cards were returned, similar to nursing results. A higher proportion of physician reports were events that caused harm compared with no effect (p reporting system, combined with appropriate education, improved overall reporting in the SICU, especially among physician providers. Nurses were more likely to use reporting systems than were physicians. Physician reports were more likely to be of events that caused harm.

  15. Design a Learning-Oriented Fall Event Reporting System Based on Kirkpatrick Model.

    Science.gov (United States)

    Zhou, Sicheng; Kang, Hong; Gong, Yang

    2017-01-01

    Patient fall has been a severe problem in healthcare facilities around the world due to its prevalence and cost. Routine fall prevention training programs are not as effective as expected. Using event reporting systems is the trend for reducing patient safety events such as falls, although some limitations of the systems exist at current stage. We summarized these limitations through literature review, and developed an improved web-based fall event reporting system. The Kirkpatrick model, widely used in the business area for training program evaluation, has been integrated during the design of our system. Different from traditional event reporting systems that only collect and store the reports, our system automatically annotates and analyzes the reported events, and provides users with timely knowledge support specific to the reported event. The paper illustrates the design of our system and how its features are intended to reduce patient falls by learning from previous errors.

  16. Automatically Recognizing Medication and Adverse Event Information From Food and Drug Administration's Adverse Event Reporting System Narratives.

    Science.gov (United States)

    Polepalli Ramesh, Balaji; Belknap, Steven M; Li, Zuofeng; Frid, Nadya; West, Dennis P; Yu, Hong

    2014-06-27

    The Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) is a repository of spontaneously-reported adverse drug events (ADEs) for FDA-approved prescription drugs. FAERS reports include both structured reports and unstructured narratives. The narratives often include essential information for evaluation of the severity, causality, and description of ADEs that are not present in the structured data. The timely identification of unknown toxicities of prescription drugs is an important, unsolved problem. The objective of this study was to develop an annotated corpus of FAERS narratives and biomedical named entity tagger to automatically identify ADE related information in the FAERS narratives. We developed an annotation guideline and annotate medication information and adverse event related entities on 122 FAERS narratives comprising approximately 23,000 word tokens. A named entity tagger using supervised machine learning approaches was built for detecting medication information and adverse event entities using various categories of features. The annotated corpus had an agreement of over .9 Cohen's kappa for medication and adverse event entities. The best performing tagger achieves an overall performance of 0.73 F1 score for detection of medication, adverse event and other named entities. In this study, we developed an annotated corpus of FAERS narratives and machine learning based models for automatically extracting medication and adverse event information from the FAERS narratives. Our study is an important step towards enriching the FAERS data for postmarketing pharmacovigilance.

  17. Hepatitis B infection reported with cancer chemotherapy: analyzing the US FDA Adverse Event Reporting System.

    Science.gov (United States)

    Sanagawa, Akimasa; Hotta, Yuji; Kataoka, Tomoya; Maeda, Yasuhiro; Kondo, Masahiro; Kawade, Yoshihiro; Ogawa, Yoshihiro; Nishikawa, Ryohei; Tohkin, Masahiro; Kimura, Kazunori

    2018-04-16

    We conducted data mining using the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database on spontaneously reported adverse events to evaluate the association between anticancer drug therapy and hepatitis B infection. Reports of hepatitis B infection were retrieved from the FAERS database. The reporting odds ratio (ROR) was used to estimate the association between hepatitis B infection and various anticancer agents and drug combinations. We detected statistically significant risk signals of hepatitis B for 33 of 64 anticancer agents by ROR (26 cytotoxicity drugs and seven molecular-targeted drugs). We focused on molecular-targeted drugs and assessed the risk of hepatitis B from specific anticancer drug combinations. The frequency of hepatitis B infection was significantly high for drugs such as rituximab, bortezomib, imatinib, and everolimus. The addition of cyclophosphamide, doxorubicin, and fludarabine to drug combinations additively enhanced the frequency of hepatitis B infection. There were no reports on hepatitis B infection associated with trastuzumab or azacitidine monotherapy. However, trastuzumab-containing regimens (e.g., combinations with docetaxel or paclitaxel) were correlated with the incidence of hepatitis B infection, similar to azacitidine monotherapy. Our findings suggest that the concomitant use of anticancer drugs, such as trastuzumab, taxane, and azacitidine, may contribute to the risk of hepatitis B infection. The unique signals detected from the public database might provide clues to eliminate the threat of HBV in oncology. © 2018 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

  18. Ventilator-Related Adverse Events: A Taxonomy and Findings From 3 Incident Reporting Systems.

    Science.gov (United States)

    Pham, Julius Cuong; Williams, Tamara L; Sparnon, Erin M; Cillie, Tam K; Scharen, Hilda F; Marella, William M

    2016-05-01

    In 2009, researchers from Johns Hopkins University's Armstrong Institute for Patient Safety and Quality; public agencies, including the FDA; and private partners, including the Emergency Care Research Institute and the University HealthSystem Consortium (UHC) Safety Intelligence Patient Safety Organization, sought to form a public-private partnership for the promotion of patient safety (P5S) to advance patient safety through voluntary partnerships. The study objective was to test the concept of the P5S to advance our understanding of safety issues related to ventilator events, to develop a common classification system for categorizing adverse events related to mechanical ventilators, and to perform a comparison of adverse events across different adverse event reporting systems. We performed a cross-sectional analysis of ventilator-related adverse events reported in 2012 from the following incident reporting systems: the Pennsylvania Patient Safety Authority's Patient Safety Reporting System, UHC's Safety Intelligence Patient Safety Organization database, and the FDA's Manufacturer and User Facility Device Experience database. Once each organization had its dataset of ventilator-related adverse events, reviewers read the narrative descriptions of each event and classified it according to the developed common taxonomy. A Pennsylvania Patient Safety Authority, FDA, and UHC search provided 252, 274, and 700 relevant reports, respectively. The 3 event types most commonly reported to the UHC and the Pennsylvania Patient Safety Authority's Patient Safety Reporting System databases were airway/breathing circuit issue, human factor issues, and ventilator malfunction events. The top 3 event types reported to the FDA were ventilator malfunction, power source issue, and alarm failure. Overall, we found that (1) through the development of a common taxonomy, adverse events from 3 reporting systems can be evaluated, (2) the types of events reported in each database were related

  19. Ventilator-Related Adverse Events: A Taxonomy and Findings From 3 Incident Reporting Systems

    Science.gov (United States)

    Pham, Julius Cuong; Williams, Tamara L; Sparnon, Erin M; Cillie, Tam K; Scharen, Hilda F; Marella, William M

    2016-01-01

    BACKGROUND: In 2009, researchers from Johns Hopkins University's Armstrong Institute for Patient Safety and Quality; public agencies, including the FDA; and private partners, including the Emergency Care Research Institute and the University HealthSystem Consortium (UHC) Safety Intelligence Patient Safety Organization, sought to form a public-private partnership for the promotion of patient safety (P5S) to advance patient safety through voluntary partnerships. The study objective was to test the concept of the P5S to advance our understanding of safety issues related to ventilator events, to develop a common classification system for categorizing adverse events related to mechanical ventilators, and to perform a comparison of adverse events across different adverse event reporting systems. METHODS: We performed a cross-sectional analysis of ventilator-related adverse events reported in 2012 from the following incident reporting systems: the Pennsylvania Patient Safety Authority's Patient Safety Reporting System, UHC's Safety Intelligence Patient Safety Organization database, and the FDA's Manufacturer and User Facility Device Experience database. Once each organization had its dataset of ventilator-related adverse events, reviewers read the narrative descriptions of each event and classified it according to the developed common taxonomy. RESULTS: A Pennsylvania Patient Safety Authority, FDA, and UHC search provided 252, 274, and 700 relevant reports, respectively. The 3 event types most commonly reported to the UHC and the Pennsylvania Patient Safety Authority's Patient Safety Reporting System databases were airway/breathing circuit issue, human factor issues, and ventilator malfunction events. The top 3 event types reported to the FDA were ventilator malfunction, power source issue, and alarm failure. CONCLUSIONS: Overall, we found that (1) through the development of a common taxonomy, adverse events from 3 reporting systems can be evaluated, (2) the types of

  20. A Hospital Nursing Adverse Events Reporting System Project: An Approach Based on the Systems Development Life Cycle.

    Science.gov (United States)

    Cao, Yingjuan; Ball, Marion

    2017-01-01

    Based on the System Development Life Cycle, a hospital based nursing adverse event reporting system was developed and implemented which integrated with the current Hospital Information System (HIS). Besides the potitive outcomes in terms of timeliness and efficiency, this approach has brought an enormous change in how the nurses report, analyze and respond to the adverse events.

  1. Reporting Vaccine Complications: What Do Obstetricians and Gynecologists Know About the Vaccine Adverse Event Reporting System?

    Directory of Open Access Journals (Sweden)

    L. O. Eckert

    2013-01-01

    Full Text Available Background. Obstetrician-gynecologists are increasingly called upon to be vaccinators as an essential part of a woman’s primary and preventive health care. Despite the established safety of vaccines, vaccine adverse events may occur. A national Vaccine Adverse Event Reporting System (VAERS is a well-established mechanism to track adverse events. However, we hypothesized that many obstetrician-gynecologists are naive to the role and use of VAERS. Methods. We devised a ten-question survey to a sample of ACOG fellows to assess their knowledge and understanding of VAERS. We performed descriptive and frequency analysis for each of the questions and used one-way analysis of variance for continuous and chi-squared for categorical variables. Results. Of the 1000 fellows who received the survey, 377 responded. Only one respondent answered all nine knowledge questions correctly, and 9.2% of physicians had used VAERS. Older physicians were less familiar with VAERS in general and with the specific objectives of VAERS in particular (χ2=10.7,P=.005. Conclusions. Obstetrician-gynecologist familiarity with VAERS is lacking. Only when the obstetrician-gynecologist is completely knowledgeable regarding standard vaccine practices, including the availability and use of programs such as VAERS, will providers be functioning as competent and complete vaccinators.

  2. Event (error and near-miss) reporting and learning system for process improvement in radiation oncology.

    Science.gov (United States)

    Mutic, Sasa; Brame, R Scott; Oddiraju, Swetha; Parikh, Parag; Westfall, Melisa A; Hopkins, Merilee L; Medina, Angel D; Danieley, Jonathan C; Michalski, Jeff M; El Naqa, Issam M; Low, Daniel A; Wu, Bin

    2010-09-01

    The value of near-miss and error reporting processes in many industries is well appreciated and typically can be supported with data that have been collected over time. While it is generally accepted that such processes are important in the radiation therapy (RT) setting, studies analyzing the effects of organized reporting and process improvement systems on operation and patient safety in individual clinics remain scarce. The purpose of this work is to report on the design and long-term use of an electronic reporting system in a RT department and compare it to the paper-based reporting system it replaced. A specifically designed web-based system was designed for reporting of individual events in RT and clinically implemented in 2007. An event was defined as any occurrence that could have, or had, resulted in a deviation in the delivery of patient care. The aim of the system was to support process improvement in patient care and safety. The reporting tool was designed so individual events could be quickly and easily reported without disrupting clinical work. This was very important because the system use was voluntary. The spectrum of reported deviations extended from minor workflow issues (e.g., scheduling) to errors in treatment delivery. Reports were categorized based on functional area, type, and severity of an event. The events were processed and analyzed by a formal process improvement group that used the data and the statistics collected through the web-based tool for guidance in reengineering clinical processes. The reporting trends for the first 24 months with the electronic system were compared to the events that were reported in the same clinic with a paper-based system over a seven-year period. The reporting system and the process improvement structure resulted in increased event reporting, improved event communication, and improved identification of clinical areas which needed process and safety improvements. The reported data were also useful for the

  3. Reporting of safeguards events

    International Nuclear Information System (INIS)

    Dwyer, P.A.; Ervin, N.E.

    1988-02-01

    On June 9, 1987, the Commission published in the Federal Register a final rule revising the reporting requirements for safeguards events. Safeguards events include actual or attempted theft of special nuclear material (SNM); actual or attempted acts or events which interrupt normal operations at power reactors due to unauthorized use of or tampering with machinery, components, or controls; certain threats made against facilities possessing SNM; and safeguards system failures impacting the effectiveness of the system. The revised rule was effective October 8, 1987. On September 14, 1987, the NRC held a workshop in Bethesda, MD, to answer affected licensees' questions on the final rule. This report documents questions discussed at the September 14 meeting, reflects a completed staff review of the answers, and supersedes previous oral comment on the topics covered

  4. Methodological Considerations for Comparison of Brand Versus Generic Versus Authorized Generic Adverse Event Reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS).

    Science.gov (United States)

    Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Peissig, Peggy L; Berg, Richard L; Page, David C; Hansen, Richard A

    2017-12-01

    The US Food and Drug Administration Adverse Event Reporting System (FAERS), a post-marketing safety database, can be used to differentiate brand versus generic safety signals. To explore the methods for identifying and analyzing brand versus generic adverse event (AE) reports. Public release FAERS data from January 2004 to March 2015 were analyzed using alendronate and carbamazepine as examples. Reports were classified as brand, generic, and authorized generic (AG). Disproportionality analyses compared reporting odds ratios (RORs) of selected known labeled serious adverse events stratifying by brand, generic, and AG. The homogeneity of these RORs was compared using the Breslow-Day test. The AG versus generic was the primary focus since the AG is identical to brand but marketed as a generic, therefore minimizing generic perception bias. Sensitivity analyses explored how methodological approach influenced results. Based on 17,521 US event reports involving alendronate and 3733 US event reports involving carbamazepine (immediate and extended release), no consistently significant differences were observed across RORs for the AGs versus generics. Similar results were obtained when comparing reporting patterns over all time and just after generic entry. The most restrictive approach for classifying AE reports yielded smaller report counts but similar results. Differentiation of FAERS reports as brand versus generic requires careful attention to risk of product misclassification, but the relative stability of findings across varying assumptions supports the utility of these approaches for potential signal detection.

  5. Adverse events following quadrivalent meningococcal CRM-conjugate vaccine (Menveo®) reported to the Vaccine Adverse Event Reporting system (VAERS), 2010-2015.

    Science.gov (United States)

    Myers, Tanya R; McNeil, Michael M; Ng, Carmen S; Li, Rongxia; Lewis, Paige W; Cano, Maria V

    2017-03-27

    Limited data are available describing the post-licensure safety of meningococcal vaccines, including Menveo®. We reviewed reports of adverse events (AEs) to the Vaccine Adverse Event Reporting System (VAERS) to assess safety in all age groups. VAERS is a national spontaneous vaccine safety surveillance system co-administered by the Centers for Disease Control and Prevention and the US Food and Drug Administration. We searched the VAERS database for US reports of adverse events in persons who received Menveo from 1 January 2010 through 31 December 2015. We clinically reviewed reports and available medical records for serious AEs, selected pre-specified outcomes, and vaccination during pregnancy. We used empirical Bayesian data mining to identify AEs that were disproportionately reported after receipt of Menveo. During the study period, VAERS received 2614 US reports after receipt of Menveo. Of these, 67 were classified as serious, including 1 report of death. Adolescents (aged 11-18years) accounted for 74% of reports. Most of the reported AEs were non-serious and described AEs consistent with data from pre-licensure studies. Anaphylaxis and syncope were the two most common events in the serious reports. We did not identify any new safety concerns after review of AEs that exceeded the data mining threshold, although we did observe disproportionate reporting for terms that were not associated with an adverse event (e.g., "incorrect drug dosage form administered", "wrong technique in drug usage process"). Although reports were limited, we did not find any evidence for concern regarding the use of Menveo during pregnancy. In our review of VAERS reports, findings of AEs were consistent with the data from pre-licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine. Copyright © 2017 Elsevier Ltd. All rights reserved.

  6. Comparison of brand versus generic antiepileptic drug adverse event reporting rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

    Science.gov (United States)

    Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Plotkina, Annya V; Peissig, Peggy L; Berg, Richard L; Page, David; Hansen, Richard A

    2017-09-01

    Despite the cost saving role of generic anti-epileptic drugs (AEDs), debate exists as to whether generic substitution of branded AEDs may lead to therapeutic failure and increased toxicity. This study compared adverse event (AE) reporting rates for brand vs. authorized generic (AG) vs. generic AEDs. Since AGs are pharmaceutically identical to brand but perceived as generics, the generic vs. AG comparison minimized potential bias against generics. Events reported to the U.S. Food and Drug Administration Adverse Event Reporting System between January 2004 to March 2015 with lamotrigine, carbamazepine, and oxcarbazepine listed as primary or secondary suspect were classified as brand, generic, or AG based on the manufacturer. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting of labeled AEs compared to reporting these events with all other drugs. The Breslow-Day statistic compared RORs across brand, AG, and other generics using a Bonferroni-corrected Pbrand and generics for all three drugs of interest (Breslow-Day Pbrands and generics have similar reporting rates after accounting for generic perception biases. Disproportional suicide reporting was observed for generics compared with AGs and brand, although this finding needs further study. Copyright © 2017 Elsevier B.V. All rights reserved.

  7. Improving linear accelerator service response with a real- time electronic event reporting system.

    Science.gov (United States)

    Hoisak, Jeremy D P; Pawlicki, Todd; Kim, Gwe-Ya; Fletcher, Richard; Moore, Kevin L

    2014-09-08

    To track linear accelerator performance issues, an online event recording system was developed in-house for use by therapists and physicists to log the details of technical problems arising on our institution's four linear accelerators. In use since October 2010, the system was designed so that all clinical physicists would receive email notification when an event was logged. Starting in October 2012, we initiated a pilot project in collaboration with our linear accelerator vendor to explore a new model of service and support, in which event notifications were also sent electronically directly to dedicated engineers at the vendor's technical help desk, who then initiated a response to technical issues. Previously, technical issues were reported by telephone to the vendor's call center, which then disseminated information and coordinated a response with the Technical Support help desk and local service engineers. The purpose of this work was to investigate the improvements to clinical operations resulting from this new service model. The new and old service models were quantitatively compared by reviewing event logs and the oncology information system database in the nine months prior to and after initiation of the project. Here, we focus on events that resulted in an inoperative linear accelerator ("down" machine). Machine downtime, vendor response time, treatment cancellations, and event resolution were evaluated and compared over two equivalent time periods. In 389 clinical days, there were 119 machine-down events: 59 events before and 60 after introduction of the new model. In the new model, median time to service response decreased from 45 to 8 min, service engineer dispatch time decreased 44%, downtime per event decreased from 45 to 20 min, and treatment cancellations decreased 68%. The decreased vendor response time and reduced number of on-site visits by a service engineer resulted in decreased downtime and decreased patient treatment cancellations.

  8. Comparison of the adverse event profiles of conventional and liposomal formulations of doxorubicin using the FDA adverse event reporting system.

    Science.gov (United States)

    Fukuda, Akiho; Tahara, Kohei; Hane, Yuuki; Matsui, Toshinobu; Sasaoka, Sayaka; Hatahira, Haruna; Motooka, Yumi; Hasegawa, Shiori; Naganuma, Misa; Abe, Junko; Nakao, Satoshi; Takeuchi, Hirofumi; Nakamura, Mitsuhiro

    2017-01-01

    Doxorubicin (DOX) is an anthracycline widely used for the treatment of solid and hematological tumors. The aim of this study was to assess the adverse event profiles of conventional DOX and liposomal DOX. This is the first study to evaluate the effect of a liposomal formulation of DOX using spontaneous reporting system (SRS) databases. The SRS used was the US Food and Drug Administration Adverse Event Reporting System (FAERS). This study relied on definitions of preferred terms provided by the Medical Dictionary for Regulatory Activities (MedDRA) and the standardized MedDRA Queries (SMQ) database. We also calculated the reporting odds ratios (RORs) of suspected drugs (conventional DOX; PEGylated-liposome DOX; non-PEGylated-liposome DOX). The FAERS database contained 7,561,254 reports from January 2004 to December 2015. The number of reported AE cases for conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX was 5039, 3780, and 349, respectively. Conventional DOX and liposomal DOX have potential risks of causing myelosuppression, cardiotoxicity, alopecia, nausea, and vomiting, among other effects. The RORs (95% CI) from SMQ for haematopoietic leucopenia associated with conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX were 12.75 (11.89-13.68), 6.43 (5.81-7.13), and 14.73 (11.42-18.99), respectively. Liposomal DOX formulations were associated with lower RORs with regard to myelosuppression, cardiotoxicity, and alopecia than the conventional DOX was. The RORs (95% CI) for palmar-plantar erythrodysesthesia (PPE) associated with conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX were 6.56 (4.74-9.07), 64.77 (56.84-73.80), and 28.76 (15.77-52.45), respectively. This study is the first to evaluate the relationship between DOX liposomal formulations and their adverse event profiles. The results indicate that careful observation for PPE is recommended with the use of liposomal DOX, especially PEGylated

  9. Comparison of the adverse event profiles of conventional and liposomal formulations of doxorubicin using the FDA adverse event reporting system.

    Directory of Open Access Journals (Sweden)

    Akiho Fukuda

    Full Text Available Doxorubicin (DOX is an anthracycline widely used for the treatment of solid and hematological tumors. The aim of this study was to assess the adverse event profiles of conventional DOX and liposomal DOX. This is the first study to evaluate the effect of a liposomal formulation of DOX using spontaneous reporting system (SRS databases. The SRS used was the US Food and Drug Administration Adverse Event Reporting System (FAERS. This study relied on definitions of preferred terms provided by the Medical Dictionary for Regulatory Activities (MedDRA and the standardized MedDRA Queries (SMQ database. We also calculated the reporting odds ratios (RORs of suspected drugs (conventional DOX; PEGylated-liposome DOX; non-PEGylated-liposome DOX. The FAERS database contained 7,561,254 reports from January 2004 to December 2015. The number of reported AE cases for conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX was 5039, 3780, and 349, respectively. Conventional DOX and liposomal DOX have potential risks of causing myelosuppression, cardiotoxicity, alopecia, nausea, and vomiting, among other effects. The RORs (95% CI from SMQ for haematopoietic leucopenia associated with conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX were 12.75 (11.89-13.68, 6.43 (5.81-7.13, and 14.73 (11.42-18.99, respectively. Liposomal DOX formulations were associated with lower RORs with regard to myelosuppression, cardiotoxicity, and alopecia than the conventional DOX was. The RORs (95% CI for palmar-plantar erythrodysesthesia (PPE associated with conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX were 6.56 (4.74-9.07, 64.77 (56.84-73.80, and 28.76 (15.77-52.45, respectively. This study is the first to evaluate the relationship between DOX liposomal formulations and their adverse event profiles. The results indicate that careful observation for PPE is recommended with the use of liposomal DOX, especially PEGylated

  10. Medication errors: an analysis comparing PHICO's closed claims data and PHICO's Event Reporting Trending System (PERTS).

    Science.gov (United States)

    Benjamin, David M; Pendrak, Robert F

    2003-07-01

    Clinical pharmacologists are all dedicated to improving the use of medications and decreasing medication errors and adverse drug reactions. However, quality improvement requires that some significant parameters of quality be categorized, measured, and tracked to provide benchmarks to which future data (performance) can be compared. One of the best ways to accumulate data on medication errors and adverse drug reactions is to look at medical malpractice data compiled by the insurance industry. Using data from PHICO insurance company, PHICO's Closed Claims Data, and PHICO's Event Reporting Trending System (PERTS), this article examines the significance and trends of the claims and events reported between 1996 and 1998. Those who misread history are doomed to repeat the mistakes of the past. From a quality improvement perspective, the categorization of the claims and events is useful for reengineering integrated medication delivery, particularly in a hospital setting, and for redesigning drug administration protocols on low therapeutic index medications and "high-risk" drugs. Demonstrable evidence of quality improvement is being required by state laws and by accreditation agencies. The state of Florida requires that quality improvement data be posted quarterly on the Web sites of the health care facilities. Other states have followed suit. The insurance industry is concerned with costs, and medication errors cost money. Even excluding costs of litigation, an adverse drug reaction may cost up to $2500 in hospital resources, and a preventable medication error may cost almost $4700. To monitor costs and assess risk, insurance companies want to know what errors are made and where the system has broken down, permitting the error to occur. Recording and evaluating reliable data on adverse drug events is the first step in improving the quality of pharmacotherapy and increasing patient safety. Cost savings and quality improvement evolve on parallel paths. The PHICO data

  11. Sequence Coding and Search System for licensee event reports: user's guide. Volume 1, Revision 1

    International Nuclear Information System (INIS)

    Greene, N.M.; Mays, G.T.; Johnson, M.P.

    1985-04-01

    Operating experience data from nuclear power plants are essential for safety and reliability analyses, especially analyses of trends and patterns. The licensee event reports (LERs) that are submitted to the Nuclear Regulatory Commission (NRC) by the nuclear power plant utilities contain much of this data. The NRC's Office for Analysis and Evaluation of Operational Data (AEOD) has developed, under contract with NSIC, a system for codifying the events reported in the LERs. The primary objective of the Sequence Coding and Search System (SCSS) is to reduce the descriptive text of the LERs to coded sequences that are both computer-readable and computer-searchable. This system provides a structured format for detailed coding of component, system, and unit effects as well as personnel errors. The database contains all current LERs submitted by nuclear power plant utilities for events occurring since 1981 and is updated on a continual basis. This four volume report documents and describes SCSS in detail. Volume 1 is a User's Guide for searching the SCSS database. This volume contains updated material through February 1985 of the working version of ORNL/NSIC-223, Vol. 1

  12. Development and feasibility of the misuse, abuse, and diversion drug event reporting system (MADDERS®).

    Science.gov (United States)

    Treister, Roi; Trudeau, Jeremiah J; Van Inwegen, Richard; Jones, Judith K; Katz, Nathaniel P

    2016-12-01

    Inappropriate use of analgesic drugs has become increasingly pervasive over the past decade. Currently, drug abuse potential is primarily assessed post-marketing; no validated tools are available to assess this potential in phase II and III clinical trials. This paper describes the development and feasibility testing of a Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS), which aims to identify potentially abuse-related events and classify them according to a recently developed classification scheme, allowing the quantification of these events in clinical trials. The system was initially conceived and designed with input from experts and patients, followed by field-testing to assess its feasibility and content validity in both completed and ongoing clinical trials. The results suggest that MADDERS is a feasible system with initial validity. It showed higher rates of the triggering events in subjects taking medications with known abuse potential than in patients taking medications without abuse potential. Additionally, experts agreed on the classification of most abuse-related events in MADDERS. MADDERS is a new systematic approach to collect information on potentially abuse-related events in clinical trials and classify them. The system has demonstrated feasibility for implementation. Additional research is ongoing to further evaluate its validity. Currently, there are no validated tools to assess drug abuse potential during clinical trials. Because of its ease of implementation, its systematic approach, and its preliminary validation results, MADDERS could provide such a tool for clinical trials. (Am J Addict 2016;25:641-651). © 2016 American Academy of Addiction Psychiatry.

  13. Sequence Coding and Search System for licensee event reports: code listings. Volume 2

    International Nuclear Information System (INIS)

    Gallaher, R.B.; Guymon, R.H.; Mays, G.T.; Poore, W.P.; Cagle, R.J.; Harrington, K.H.; Johnson, M.P.

    1985-04-01

    Operating experience data from nuclear power plants are essential for safety and reliability analyses, especially analyses of trends and patterns. The licensee event reports (LERs) that are submitted to the Nuclear Regulatory Commission (NRC) by the nuclear power plant utilities contain much of this data. The NRC's Office for Analysis and Evaluation of Operational Data (AEOD) has developed, under contract with NSIC, a system for codifying the events reported in the LERs. The primary objective of the Sequence Coding and Search System (SCSS) is to reduce the descriptive text of the LERs to coded sequences that are both computer-readable and computer-searchable. This system provides a structured format for detailed coding of component, system, and unit effects as well as personnel errors. The database contains all current LERs submitted by nuclear power plant utilities for events occurring since 1981 and is updated on a continual basis. Volume 2 contains all valid and acceptable codes used for searching and encoding the LER data. This volume contains updated material through amendment 1 to revision 1 of the working version of ORNL/NSIC-223, Vol. 2

  14. Vaccine adverse event text mining system for extracting features from vaccine safety reports.

    Science.gov (United States)

    Botsis, Taxiarchis; Buttolph, Thomas; Nguyen, Michael D; Winiecki, Scott; Woo, Emily Jane; Ball, Robert

    2012-01-01

    To develop and evaluate a text mining system for extracting key clinical features from vaccine adverse event reporting system (VAERS) narratives to aid in the automated review of adverse event reports. Based upon clinical significance to VAERS reviewing physicians, we defined the primary (diagnosis and cause of death) and secondary features (eg, symptoms) for extraction. We built a novel vaccine adverse event text mining (VaeTM) system based on a semantic text mining strategy. The performance of VaeTM was evaluated using a total of 300 VAERS reports in three sequential evaluations of 100 reports each. Moreover, we evaluated the VaeTM contribution to case classification; an information retrieval-based approach was used for the identification of anaphylaxis cases in a set of reports and was compared with two other methods: a dedicated text classifier and an online tool. The performance metrics of VaeTM were text mining metrics: recall, precision and F-measure. We also conducted a qualitative difference analysis and calculated sensitivity and specificity for classification of anaphylaxis cases based on the above three approaches. VaeTM performed best in extracting diagnosis, second level diagnosis, drug, vaccine, and lot number features (lenient F-measure in the third evaluation: 0.897, 0.817, 0.858, 0.874, and 0.914, respectively). In terms of case classification, high sensitivity was achieved (83.1%); this was equal and better compared to the text classifier (83.1%) and the online tool (40.7%), respectively. Our VaeTM implementation of a semantic text mining strategy shows promise in providing accurate and efficient extraction of key features from VAERS narratives.

  15. Signal Detection of Imipenem Compared to Other Drugs from Korea Adverse Event Reporting System Database.

    Science.gov (United States)

    Park, Kyounghoon; Soukavong, Mick; Kim, Jungmee; Kwon, Kyoung Eun; Jin, Xue Mei; Lee, Joongyub; Yang, Bo Ram; Park, Byung Joo

    2017-05-01

    To detect signals of adverse drug events after imipenem treatment using the Korea Institute of Drug Safety & Risk Management-Korea adverse event reporting system database (KIDS-KD). We performed data mining using KIDS-KD, which was constructed using spontaneously reported adverse event (AE) reports between December 1988 and June 2014. We detected signals calculated the proportional reporting ratio, reporting odds ratio, and information component of imipenem. We defined a signal as any AE that satisfied all three indices. The signals were compared with drug labels of nine countries. There were 807582 spontaneous AEs reports in the KIDS-KD. Among those, the number of antibiotics related AEs was 192510; 3382 reports were associated with imipenem. The most common imipenem-associated AE was the drug eruption; 353 times. We calculated the signal by comparing with all other antibiotics and drugs; 58 and 53 signals satisfied the three methods. We compared the drug labelling information of nine countries, including the USA, the UK, Japan, Italy, Switzerland, Germany, France, Canada, and South Korea, and discovered that the following signals were currently not included in drug labels: hypokalemia, cardiac arrest, cardiac failure, Parkinson's syndrome, myocardial infarction, and prostate enlargement. Hypokalemia was an additional signal compared with all other antibiotics, and the other signals were not different compared with all other antibiotics and all other drugs. We detected new signals that were not listed on the drug labels of nine countries. However, further pharmacoepidemiologic research is needed to evaluate the causality of these signals. © Copyright: Yonsei University College of Medicine 2017

  16. Adverse event reporting patterns of newly approved drugs in the USA in 2006: an analysis of FDA Adverse Event Reporting System data.

    Science.gov (United States)

    Chhabra, Pankdeep; Chen, Xing; Weiss, Sheila R

    2013-11-01

    The Weber effect states that adverse event (AE) reporting tends to increase in the first 2 years after a new drug is placed onto the market, peaks at the end of the second year, and then declines. However, since the Weber effect was originally described, there has been improvement in the communication of safety information and new policies regarding the reporting of AEs by healthcare professionals and consumers, prompting reassessment of the existence of the Weber effect in the current AE reporting scenario. To determine the AE reporting patterns for new molecular entity (NME) drugs and biologics approved in 2006 and to examine these patterns for the existence of the Weber effect. Publicly available FDA Adverse Event Reporting System data were used to assess the AE reporting patterns for a 5-year period from the drug’s approval date. The total number of annual reports from all sources, based on the report date, was plotted against time (in years). In the period from 2006 to 2011, a total of 91,187 AE reports were submitted for 19 NMEs approved in 2006. The highest number of AE reports were submitted for varenicline tartrate (N = 47,158) and the lowest number for anidulafungin (N = 161). Anidulafungin was reported to have the highest proportion of death reports (36 %) and varenicline tartrate the lowest proportion (1.7 %). The classic Weber pattern was not observed for any of the 19 NMEs approved in 2006. While there was no one predominant pattern of AE report volume, we grouped the drugs into four general categories; the majority of drugs had either a continued increase in reports (Category A 31.6 %) or an N-pattern with reporting reaching an initial peak in year 2 or 3, declining and then beginning to climb again (Category B 42.1 %). There have been numerous changes in AE reporting, particularly a huge increase in overall annual report volume, since the Weber effect was first reported. Our results suggest that a Weber-type reporting pattern should not be assumed

  17. Recent events in NPPs and incident reporting system (IRS) activity. Working material

    International Nuclear Information System (INIS)

    1996-01-01

    The IAEA convened the 1996 Joint Meeting to Exchange Information on Recent Events in Nuclear Power Plants and the Technical Committee-Annual Meeting of the Incident Reporting System (IRS) national co-ordinators, organized jointly with the Nuclear Energy Agency (NEA) of the OECD in Paris, France from 22-26 April 1996. These consecutive meetings took place at the OECD Headquarters, 2 rue Andre Pascal. The main objective of the first meeting (22-24 April 1996) was to exchange and discuss information on recent events which occurred in NPPs. The second meeting (25-26 April 1996) was devoted to the IAEA and NEA activity in the framework of the IRS. The main issues of the programme at the meetings were as follows: in-depth discussion on NPP recent events, presented by the participants; panel discussion on operational safety experience issues identified by the participants; IAEA and NEA activities on IRS subjects in 1995-1996 and plans for the future; issues from the inter-agency's IRS Advisory Committee. Annexes I and II provide more information on the programme at the meetings. A list of participants is given in Annex III (50 participants from 22 countries and 3 international organization). Annexes IV and V provide information on national presentations on recent events. Figs, tabs

  18. Sequence Coding and Search System for licensee event reports: coder's manual. Volume 4

    International Nuclear Information System (INIS)

    Gallaher, R.B.; Guymon, R.H.; Mays, G.T.; Poore, W.P.; Cagle, R.J.; Harrington, K.H.; Johnson, M.P.

    1985-04-01

    Operating experience data from nuclear power plants are essential for safety and reliability analyses, especially analyses of trends and patterns. The licensee event reports (LERs) that are submitted to the Nuclear Regulatory Commission (NRC) by the nuclear power plant utilities contain much of this data. The NRC's Office for Analysis and Evaluation of Operational Data (AEOD) has developed, under contract with NSIC, a system for codifying the events reported in the LERs. The primary objective of the Sequence Coding and Search System (SCSS) is to reduce the descriptive text of the LERs to coded sequences that are both computer-readable and computer-searchable. This four volume report documents and describes SCSS in detail. Volume 3 and 4 provide a technical processor, new to SCSS, the information and methodology necessary to capture descriptive data from the LER and to codify that data into a structured format and serve as reference material for the more experienced technical processor, and contains information that is essential for the more advanced user who needs to be familiar with the intricate coding techniques in order to retrieve specific details in a sequence. This volume contains updated material through amendment 1 to revision 1 of the working version of ORNL/NSIC-223, Vol. 4

  19. Sequence Coding and Search System for licensee event reports: coder's manual. Volume 3

    International Nuclear Information System (INIS)

    Gallaher, R.B.; Guymon, R.H.; Mays, G.T.; Poore, W.P.; Cagle, R.J.; Harrington, K.H.; Johnson, M.P.

    1985-04-01

    Operating experience data from nuclear power plants are essential for safety and reliability analyses, especially analyses of trends and patterns. The licensee event reports (LERs) that are submitted to the Nuclear Regulatory Commission (NRC) by the nuclear power plant utilities contain much of this data. The NRC's Office for Analysis and Evaluation of Operational Data (AEOD) has developed, under contract with NSIC, a system for codifying the events reported in the LERs. The primary objective of the Sequence Coding and Search System (SCSS) is to reduce the descriptive text of the LERs to coded sequences that are both computer-readable and computer-searchable. This four volume report documents and describes SCSS in detail. Volumes 3 and 4 provide a technical processor, new to SCSS, the information and methodology necessary to capture descriptive data from the LER and to codify that data into a structured format and serve as reference material for the more experienced technical processor, and contains information is essential for the more advanced user who needs to be familiar with the intricate coding techniques in order to retrieve specific details in a sequence. This volume contains updated material through amendment 1 to revision 1 of the working version of ORNL/NSIC-223, Vol. 3

  20. Motor palsies of cranial nerves (excluding VII) after vaccination: reports to the US Vaccine Adverse Event Reporting System.

    Science.gov (United States)

    Woo, Emily Jane; Winiecki, Scott K; Ou, Alan C

    2014-01-01

    We reviewed cranial nerve palsies, other than VII, that have been reported to the US Vaccine Adverse Event Reporting System (VAERS). We examined patterns for differences in vaccine types, seriousness, age, and clinical characteristics. We identified 68 reports of cranial nerve palsies, most commonly involving the oculomotor (III), trochlear (IV), and abducens (VI) nerves. Isolated cranial nerve palsies, as well as palsies occurring as part of a broader clinical entity, were reported. Forty reports (59%) were classified as serious, suggesting that a cranial nerve palsy may sometimes be the harbinger of a broader and more ominous clinical entity, such as a stroke or encephalomyelitis. There was no conspicuous clustering of live vs. inactivated vaccines. The patient age range spanned the spectrum from infants to the elderly. Independent data may help to clarify whether, when, and to what extent the rates of cranial nerve palsies following particular vaccines may exceed background levels.

  1. Acute disseminated encephalomyelitis onset: evaluation based on vaccine adverse events reporting systems.

    Directory of Open Access Journals (Sweden)

    Paolo Pellegrino

    Full Text Available OBJECTIVE: To evaluate epidemiological features of post vaccine acute disseminated encephalomyelitis (ADEM by considering data from different pharmacovigilance surveillance systems. METHODS: The Vaccine Adverse Event Reporting System (VAERS database and the EudraVigilance post-authorisation module (EVPM were searched to identify post vaccine ADEM cases. Epidemiological features including sex and related vaccines were analysed. RESULTS: We retrieved 205 and 236 ADEM cases from the EVPM and VAERS databases, respectively, of which 404 were considered for epidemiological analysis following verification and causality assessment. Half of the patients had less than 18 years and with a slight male predominance. The time interval from vaccination to ADEM onset was 2-30 days in 61% of the cases. Vaccine against seasonal flu and human papilloma virus vaccine were those most frequently associated with ADEM, accounting for almost 30% of the total cases. Mean number of reports per year between 2005 and 2012 in VAERS database was 40±21.7, decreasing after 2010 mainly because of a reduction of reports associated with human papilloma virus and Diphtheria, Pertussis, Tetanus, Polio and Haemophilus Influentiae type B vaccines. CONCLUSIONS: This study has a high epidemiological power as it is based on information on adverse events having occurred in over one billion people. It suffers from lack of rigorous case verification due to the weakness intrinsic to the surveillance databases used. At variance with previous reports on a prevalence of ADEM in childhood we demonstrate that it may occur at any age when post vaccination. This study also shows that the diminishing trend in post vaccine ADEM reporting related to Diphtheria, Pertussis, Tetanus, Polio and Haemophilus Influentiae type B and human papilloma virus vaccine groups is most likely not [corrected] due to a decline in vaccine coverage indicative of a reduced attention to this adverse drug reaction.

  2. Stimulated reporting: the impact of US food and drug administration-issued alerts on the adverse event reporting system (FAERS).

    Science.gov (United States)

    Hoffman, Keith B; Demakas, Andrea R; Dimbil, Mo; Tatonetti, Nicholas P; Erdman, Colin B

    2014-11-01

    The US Food and Drug Administration (FDA) uses the Adverse Event Reporting System (FAERS) to support post-marketing safety surveillance programs. Currently, almost one million case reports are submitted to FAERS each year, making it a vast repository of drug safety information. Sometimes cited as a limitation of FAERS, however, is the assumption that "stimulated reporting" of adverse events (AEs) occurs in response to warnings, alerts, and label changes that are issued by the FDA. To determine the extent of "stimulated reporting" in the modern-day FAERS database. One hundred drugs approved by the FDA between 2001 and 2010 were included in this analysis. FDA alerts were obtained by a comprehensive search of the FDA's MedWatch and main websites. Publicly available FAERS data were used to assess the "primary suspect" AE reporting pattern for up to four quarters before, and after, the issuance of an FDA alert. A few drugs did demonstrate "stimulated reporting" trends. A majority of the drugs, however, showed little evidence for significant reporting changes associated with the issuance of alerts. When we compared the percentage changes in reporting after an FDA alert with those after a sham "control alert", the overall reporting trends appeared to be quite similar. Of 100 drugs analyzed for short-term reporting trends, 21 real alerts and 25 sham alerts demonstrated an increase (greater than or equal to 1 %) in reporting. The long-term analysis of 91 drugs showed that 24 real alerts and 28 sham alerts demonstrated a greater than or equal to 1 % increase. Our results suggest that most of modern day FAERS reporting is not significantly affected by the issuance of FDA alerts.

  3. An experimental investigation of masking in the US FDA adverse event reporting system database.

    Science.gov (United States)

    Wang, Hsin-wei; Hochberg, Alan M; Pearson, Ronald K; Hauben, Manfred

    2010-12-01

    A phenomenon of 'masking' or 'cloaking' in pharmacovigilance data mining has been described, which can potentially cause signals of disproportionate reporting (SDRs) to be missed, particularly in pharmaceutical company databases. Masking has been predicted theoretically, observed anecdotally or studied to a limited extent in both pharmaceutical company and health authority databases, but no previous publication systematically assesses its occurrence in a large health authority database. To explore the nature, extent and possible consequences of masking in the US FDA Adverse Event Reporting System (AERS) database by applying various experimental unmasking protocols to a set of drugs and events representing realistic pharmacovigilance analysis conditions. This study employed AERS data from 2001 through 2005. For a set of 63 Medical Dictionary for Regulatory Activities (MedDRA®) Preferred Terms (PTs), disproportionality analysis was carried out with respect to all drugs included in the AERS database, using a previously described urn-model-based algorithm. We specifically sought masking in which drug removal induced an increase in the statistical representation of a drug-event combination (DEC) that resulted in the emergence of a new SDR. We performed a series of unmasking experiments selecting drugs for removal using rational statistical decision rules based on the requirement of a reporting ratio (RR) >1, top-ranked statistical unexpectedness (SU) and relatedness as reflected in the WHO Anatomical Therapeutic Chemical level 4 (ATC4) grouping. In order to assess the possible extent of residual masking we performed two supplemental purely empirical analyses on a limited subset of data. This entailed testing every drug and drug group to determine which was most influential in uncovering masked SDRs. We assessed the strength of external evidence for a causal association for a small number of masked SDRs involving a subset of 29 drugs for which level of evidence

  4. Event Index - a LHCb Event Search System

    CERN Document Server

    INSPIRE-00392208; Kazeev, Nikita; Redkin, Artem

    2015-12-23

    LHC experiments generate up to $10^{12}$ events per year. This paper describes Event Index - an event search system. Event Index's primary function is quickly selecting subsets of events from a combination of conditions, such as the estimated decay channel or stripping lines output. Event Index is essentially Apache Lucene optimized for read-only indexes distributed over independent shards on independent nodes.

  5. Application of information retrieval approaches to case classification in the vaccine adverse event reporting system.

    Science.gov (United States)

    Botsis, Taxiarchis; Woo, Emily Jane; Ball, Robert

    2013-07-01

    Automating the classification of adverse event reports is an important step to improve the efficiency of vaccine safety surveillance. Previously we showed it was possible to classify reports using features extracted from the text of the reports. The aim of this study was to use the information encoded in the Medical Dictionary for Regulatory Activities (MedDRA(®)) in the US Vaccine Adverse Event Reporting System (VAERS) to support and evaluate two classification approaches: a multiple information retrieval strategy and a rule-based approach. To evaluate the performance of these approaches, we selected the conditions of anaphylaxis and Guillain-Barré syndrome (GBS). We used MedDRA(®) Preferred Terms stored in the VAERS, and two standardized medical terminologies: the Brighton Collaboration (BC) case definitions and Standardized MedDRA(®) Queries (SMQ) to classify two sets of reports for GBS and anaphylaxis. Two approaches were used: (i) the rule-based instruments that are available by the two terminologies (the Automatic Brighton Classification [ABC] tool and the SMQ algorithms); and (ii) the vector space model. We found that the rule-based instruments, particularly the SMQ algorithms, achieved a high degree of specificity; however, there was a cost in terms of sensitivity in all but the narrow GBS SMQ algorithm that outperformed the remaining approaches (sensitivity in the testing set was equal to 99.06 % for this algorithm vs. 93.40 % for the vector space model). In the case of anaphylaxis, the vector space model achieved higher sensitivity compared with the best values of both the ABC tool and the SMQ algorithms in the testing set (86.44 % vs. 64.11 % and 52.54 %, respectively). Our results showed the superiority of the vector space model over the existing rule-based approaches irrespective of the standardized medical knowledge represented by either the SMQ or the BC case definition. The vector space model might make automation of case definitions for

  6. The global event system

    International Nuclear Information System (INIS)

    Winans, J.

    1994-01-01

    The support for the global event system has been designed to allow an application developer to control the APS event generator and receiver boards. This is done by the use of four new record types. These records are customized and are only supported by the device support modules for the APS event generator and receiver boards. The use of the global event system and its associated records should not be confused with the vanilla EPICS events and the associated event records. They are very different

  7. Antipsychotics, glycemic disorders, and life-threatening diabetic events: a Bayesian data-mining analysis of the FDA adverse event reporting system (1968-2004).

    Science.gov (United States)

    DuMouchel, William; Fram, David; Yang, Xionghu; Mahmoud, Ramy A; Grogg, Amy L; Engelhart, Luella; Ramaswamy, Krishnan

    2008-01-01

    This analysis compared diabetes-related adverse events associated with use of different antipsychotic agents. A disproportionality analysis of the US Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) was performed. Data from the FDA postmarketing AERS database (1968 through first quarter 2004) were evaluated. Drugs studied included aripiprazole, clozapine, haloperidol, olanzapine, quetiapine, risperidone, and ziprasidone. Fourteen Medical Dictionary for Regulatory Activities (MedDRA) Primary Terms (MPTs) were chosen to identify diabetes-related adverse events; 3 groupings into higher-level descriptive categories were also studied. Three methods of measuring drug-event associations were used: proportional reporting ratio, the empirical Bayes data-mining algorithm known as the Multi-Item Gamma Poisson Shrinker, and logistic regression (LR) analysis. Quantitative measures of association strength, with corresponding confidence intervals, between drugs and specified adverse events were computed and graphed. Some of the LR analyses were repeated separately for reports from patients under and over 45 years of age. Differences in association strength were declared statistically significant if the corresponding 90% confidence intervals did not overlap. Association with various glycemic events differed for different drugs. On average, the rankings of association strength agreed with the following ordering: low association, ziprasidone, aripiprazole, haloperidol, and risperidone; medium association, quetiapine; and strong association, clozapine and olanzapine. The median rank correlation between the above ordering and the 17 sets of LR coefficients (1 set for each glycemic event) was 93%. Many of the disproportionality measures were significantly different across drugs, and ratios of disproportionality factors of 5 or more were frequently observed. There are consistent and substantial differences between atypical antipsychotic drugs in the

  8. The reliability of manual reporting of clinical events in an anesthesia information management system (AIMS).

    Science.gov (United States)

    Simpao, Allan F; Pruitt, Eric Y; Cook-Sather, Scott D; Gurnaney, Harshad G; Rehman, Mohamed A

    2012-12-01

    Manual incident reports significantly under-report adverse clinical events when compared with automated recordings of intraoperative data. Our goal was to determine the reliability of AIMS and CQI reports of adverse clinical events that had been witnessed and recorded by research assistants. The AIMS and CQI records of 995 patients aged 2-12 years were analyzed to determine if anesthesia providers had properly documented the emesis events that were observed and recorded by research assistants who were present in the operating room at the time of induction. Research assistants recorded eight cases of emesis during induction that were confirmed with the attending anesthesiologist at the time of induction. AIMS yielded a sensitivity of 38 % (95 % confidence interval [CI] 8.5-75.5 %), while the sensitivity of CQI reporting was 13 % (95 % CI 0.3-52.7 %). The low sensitivities of the AIMS and CQI reports suggest that user-reported AIMS and CQI data do not reliably include significant clinical events.

  9. Review of nuclear air treatment system related License Event Reports for the period 1985 - 1987

    International Nuclear Information System (INIS)

    Jacox, J.W.

    1989-01-01

    This paper will continue the review of HVAC/NATS related LERS presented at past Air Cleaning Conferences by Dr. D. W. Moeller and his associates. The general approach and format are similar. LER abstracts from mid 1985 through 1987 were reviewed and those related to HVAC/NATS classified and analyzed. The categories were jointly developed by Dr. Moeller, Dr. Casper Sun and myself. In appropriate cases both primary and secondary categories fora problem are given. A basic listing by category and brief statistical review are presented. Additionally a number of categories are discussed in some detail. The categories chosen for specific review are intended to highlight particular problem areas. NUREG/CR-2000 License Event Report (LER) Compilation is the basis for the initial review and coding. In essentially all cases where an LER is classified as of interest the complete LER was obtained and reviewed in full. The intent of this paper is to provide a basis for the industry to document and analyze problem areas that require additional attention. It appears that about 15% of all LERS in the subject period are HVAC/NATS related. This figure is generally consistent with those reported at the 17th DOE Nuclear Air Cleaning Conference. It is hoped that such attention will allow additional resources to be allocated to upgrade systems, procedures and training as well as in some cases government regulation

  10. Statin-associated muscular and renal adverse events: data mining of the public version of the FDA adverse event reporting system.

    Directory of Open Access Journals (Sweden)

    Toshiyuki Sakaeda

    Full Text Available OBJECTIVE: Adverse event reports (AERs submitted to the US Food and Drug Administration (FDA were reviewed to assess the muscular and renal adverse events induced by the administration of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA reductase inhibitors (statins and to attempt to determine the rank-order of the association. METHODS: After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving pravastatin, simvastatin, atorvastatin, or rosuvastatin were analyzed. Authorized pharmacovigilance tools were used for quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Myalgia, rhabdomyolysis and an increase in creatine phosphokinase level were focused on as the muscular adverse events, and acute renal failure, non-acute renal failure, and an increase in blood creatinine level as the renal adverse events. RESULTS: Based on 1,644,220 AERs from 2004 to 2009, signals were detected for 4 statins with respect to myalgia, rhabdomyolysis, and an increase in creatine phosphokinase level, but these signals were stronger for rosuvastatin than pravastatin and atorvastatin. Signals were also detected for acute renal failure, though in the case of atorvastatin, the association was marginal, and furthermore, a signal was not detected for non-acute renal failure or for an increase in blood creatinine level. CONCLUSIONS: Data mining of the FDA's adverse event reporting system, AERS, is useful for examining statin-associated muscular and renal adverse events. The data strongly suggest the necessity of well-organized clinical studies with respect to statin-associated adverse events.

  11. Statin-associated muscular and renal adverse events: data mining of the public version of the FDA adverse event reporting system.

    Science.gov (United States)

    Sakaeda, Toshiyuki; Kadoyama, Kaori; Okuno, Yasushi

    2011-01-01

    Adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) were reviewed to assess the muscular and renal adverse events induced by the administration of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) and to attempt to determine the rank-order of the association. After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving pravastatin, simvastatin, atorvastatin, or rosuvastatin were analyzed. Authorized pharmacovigilance tools were used for quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Myalgia, rhabdomyolysis and an increase in creatine phosphokinase level were focused on as the muscular adverse events, and acute renal failure, non-acute renal failure, and an increase in blood creatinine level as the renal adverse events. Based on 1,644,220 AERs from 2004 to 2009, signals were detected for 4 statins with respect to myalgia, rhabdomyolysis, and an increase in creatine phosphokinase level, but these signals were stronger for rosuvastatin than pravastatin and atorvastatin. Signals were also detected for acute renal failure, though in the case of atorvastatin, the association was marginal, and furthermore, a signal was not detected for non-acute renal failure or for an increase in blood creatinine level. Data mining of the FDA's adverse event reporting system, AERS, is useful for examining statin-associated muscular and renal adverse events. The data strongly suggest the necessity of well-organized clinical studies with respect to statin-associated adverse events.

  12. Licensee Event Report System. Evaluation of first year results, and recommendations for improvements. Supplement No. 2

    International Nuclear Information System (INIS)

    1985-09-01

    This report describes an evaluation of an industry-wide sample of Licensee Event Reports (LERs) that was conducted to determine whether or not these LERs were prepared in accordance with the requirements set forth in 10 CFR 50.73. The study was performed at the Idaho National Engineering Laboratory (INEL), by EG and G, Inc. This evaluation (NUREG/CR-4178) indicated that although the overall quality of the LERs was good, many LERs failed to meet all of the requirements. This report presents the methodology that was used to evaluate the LERs, the conclusions reached concerning problem areas in the reports, and suggestions as to how the overall quality and completeness of reports can be improved

  13. Analysis of the Interaction between Clopidogrel, Aspirin, and Proton Pump Inhibitors Using the FDA Adverse Event Reporting System Database.

    Science.gov (United States)

    Suzuki, Yukiya; Suzuki, Honami; Umetsu, Ryogo; Uranishi, Hiroaki; Abe, Junko; Nishibata, Yuri; Sekiya, Yasuaki; Miyamura, Nobuteru; Hara, Hideaki; Tsuchiya, Teruo; Kinosada, Yasutomi; Nakamura, Mitsuhiro

    2015-01-01

    Clopidogrel is an antiplatelet agent widely used in combination with aspirin to limit the occurrence of cardiovascular (embolic/thrombotic) events. Consensus guidelines recommend proton pump inhibitors (PPIs) as a gastrointestinal (GI) prophylactic measure for all patients receiving dual antiplatelet therapy with clopidogrel and aspirin. The objective of this study was to analyze the effect of the simultaneous use of clopidogrel, aspirin, and PPIs on hemorrhagic and embolic/thrombotic events using the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. Reports of hemorrhagic and embolic/thrombotic events between 2004 and 2013 were analyzed with a reporting odds ratio (ROR) algorithm and logistic regression methods. The Medical Dictionary for Regulatory Activities Preferred Terms was used to identify such events. Regarding hemorrhagic events, the adjusted RORs of the concomitant use of aspirin and clopidogrel and those of PPIs prescribed with aspirin and clopidogrel were 4.40 (95% confidence interval [CI], 4.02-4.81) and 3.40 (95% CI, 2.84-4.06), respectively. For embolic/thrombotic events, the adjusted RORs of the concomitant use of aspirin and clopidogrel and those of PPIs prescribed with aspirin and clopidogrel were 2.37 (95% CI, 2.16-2.59) and 2.38 (95% CI, 2.00-2.84), respectively. Among patients included in the FAERS database, the concurrent use of aspirin and clopidogrel with PPIs reduced the adjusted ROR of GI hemorrhagic events. PPIs had little influence on the adjusted ROR of embolic/thrombotic events. These results support the use of PPIs as a preventive measure against GI hemorrhagic events for patients receiving clopidogrel and aspirin.

  14. Hypersensitivity reactions to anticancer agents: Data mining of the public version of the FDA adverse event reporting system, AERS

    Directory of Open Access Journals (Sweden)

    Sakaeda Toshiyuki

    2011-10-01

    Full Text Available Abstract Background Previously, adverse event reports (AERs submitted to the US Food and Drug Administration (FDA database were reviewed to confirm platinum agent-associated hypersensitivity reactions. The present study was performed to confirm whether the database could suggest the hypersensitivity reactions caused by anticancer agents, paclitaxel, docetaxel, procarbazine, asparaginase, teniposide, and etoposide. Methods After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving candidate agents were analyzed. The National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 was applied to evaluate the susceptibility to hypersensitivity reactions, and standardized official pharmacovigilance tools were used for quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Results Based on 1,644,220 AERs from 2004 to 2009, the signals were detected for paclitaxel-associated mild, severe, and lethal hypersensitivity reactions, and docetaxel-associated lethal reactions. However, the total number of adverse events occurring with procarbazine, asparaginase, teniposide, or etoposide was not large enough to detect signals. Conclusions The FDA's adverse event reporting system, AERS, and the data mining methods used herein are useful for confirming drug-associated adverse events, but the number of co-occurrences is an important factor in signal detection.

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

    Science.gov (United States)

    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

  16. Extreme Energy Events Monitoring report

    CERN Document Server

    Baimukhamedova, Nigina

    2015-01-01

    Following paper reflects the progress I made on Summer Student Program within Extreme Energy Events Monitor project I was working on. During 8 week period I managed to build a simple detector system that is capable of triggering events similar to explosions (sudden change in sound levels) and measuring approximate location of the event. Source codes are available upon request and settings described further.

  17. Cognition- and Dementia-Related Adverse Effects With Sacubitril-Valsartan: Analysis of the FDA Adverse Event Report System Database.

    Science.gov (United States)

    Perlman, Amichai; Hirsh Raccah, Bruria; Matok, Ilan; Muszkat, Mordechai

    2018-05-07

    Because neprilysin is involved in the degradation of amyloid-beta, there is concern that the angiotensin-neprilysin inhibitor sacubitril-valsartan could increase the risk for dementia. We analyzed adverse event cases submitted to the Food and Drug Administration Adverse Event Report System from July 2015 to March 2017. Cognition- and dementia-related adverse event cases were defined with the use of broad and narrow structured medical queries. During the period evaluated, 9,004 adverse event reports (out of a total of 2,249,479) involved the use of sacubitril-valsartan. Based on the broad definition, sacubitril-valsartan was associated with cognition- and dementia-related adverse events in 459 reports (5.1%), but this was lower than the proportion of these reports among other medications (6.6%, reporting odds ratio [ROR] 0.72, 95% confidence interval [CI] 0.65-0.79). Restricting the comparison to cases with age >60 years and with the use of a comparator group with heart failure resulted in no association between sacubitril-valsartan and dementia-related adverse events, with the use of both the broad and the narrow definitions (ROR 0.87, 95% CI 0.76-1.02, and ROR 1.06, 95% CI 0.4-3.16, respectively). Sacubitril-valsartan is not associated with a disproportionately high rate of short-term dementia-related adverse effect reports. Long-term studies assessing cognitive outcomes are required to better establish the medication's cognition effects. Copyright © 2018 Elsevier Inc. All rights reserved.

  18. Licensee Event Report (LER) compilation, March 1992

    International Nuclear Information System (INIS)

    1992-05-01

    This monthly report contains Licensee Event Report (LER) operational information that was processed into the LER data file of the Nuclear Operations Analysis Center (NOAC) during the one month period identified on the cover of the document. The LERs, from which this information is derived, are submitted to the Nuclear Regulatory Commission (NRC) by nuclear power plant licensees in accordance with federal regulations. Procedures for LER reporting for revisions to those events occurring prior to 1984 are described in NRC Regulatory Guide 1.16 and NUREG-0161, Instructions for Preparation of Data Entry Sheets for Licensee Event Reports. For those events occurring on and after January 1, 1984, LERs are being submitted in accordance with the revised rule contained in Title 10 Part 50.73 of the Code of Federal Regulations (10 CFR 50.73 -- Licensee Event Report System) which was published in the Federal Register (Vol. 48, No. 144) on July 26, 1983. NUREG-1022, Licensee Event Report System -- Description of Systems and Guidelines for Reporting, provides supporting guidance and information on the revised LER rule. The LER summaries in this report are arranged alphabetically by facility name and then chronologically by event date for each facility. Component, system, keyword, and component vendor indexes follow the summaries. Vendors are those identified by the utility when the LER form is initiated; the keywords for the component, system, and general keyword indexes are assigned by the computer using correlation tables from the Sequence Coding and Search System

  19. Licensee Event Report (LER) compilation, April 1991

    International Nuclear Information System (INIS)

    1991-05-01

    This monthly report contains Licensee Event Report (LER) operational information that was processed into the LER data file of the Nuclear Safety Information Center (NSIC) during the one month period identified on the cover of the document. The LERs, from which this information is derived, are submitted to the Nuclear Regulatory Commission (NRC) by nuclear power plant licensees in accordance with federal regulations. Procedures for LER reporting for revisions to those events occurring prior to 1984 are described in NRC Regulatory Guide 1.16 and NUREG-0161, Instructions for Preparation of Data Entry Sheets for Licensee Event Reports. For those events occurring on and after January 1, 1984, LERs are being submitted in accordance with the revised rule contained in Title 10 Part 50.73 of the Code of Federal Regulations (10 CFR 50.73 -- Licensee Event Report System) which was published in the Federal Register (Vol. 48, No. 144) on July 26, 1983. NUREG-1022, Licensee Event Report System -- Description of Systems and Guidelines for Reporting, provides supporting guidance and information on the revised LER rule. The LER summaries in this report are arranged alphabetically by facility name and then chronologically by event date for each facility. Component, system, keyword, and component vendor indexes follow the summaries. Vendors are those identified by the utility when the LER form is initiated; the keywords for the component, system, and general keyword indexes are assigned by the computer using correlation tables from the Sequence Coding and Search System

  20. Unusual event report from Oskarshamn

    International Nuclear Information System (INIS)

    1996-01-01

    The title of the report was intended to reflect the cause of the shutdown and the report to be regarded as a summary of the deficiencies that had been revealed and remedied. No single deficiency was regarded as reportable as an unusual event, but taken together the identified deficiencies deviated from the assumed safety level to the extent that it should be reported. The unusual event report refers to two main documents presenting measures taken to return to reported safety level, one concerning technical and one organizational measures

  1. Lessons Learned from the Evolution of Mandatory Adverse Event Reporting Systems

    Science.gov (United States)

    2005-05-01

    related to treatment, such as nosocomial infections and unintended effects of drugs and medical devices, is collected by the Centers for Disease...Nontreatment-related events (such as criminal acts, specified statutory events, and nosocomial infection outbreaks) • Treatment and procedure...1.8 Ventilator death/injury 38 1.5 Anesthesia-related event 35 1.4 Infection -related event 34 1.4 Medical equipment-related 32 1.3 Maternal death

  2. Nurses' systems thinking competency, medical error reporting, and the occurrence of adverse events: a cross-sectional study.

    Science.gov (United States)

    Hwang, Jee-In; Park, Hyeoun-Ae

    2017-12-01

    Healthcare professionals' systems thinking is emphasized for patient safety. To report nurses' systems thinking competency, and its relationship with medical error reporting and the occurrence of adverse events. A cross-sectional survey using a previously validated Systems Thinking Scale (STS), was conducted. Nurses from two teaching hospitals were invited to participate in the survey. There were 407 (60.3%) completed surveys. The mean STS score was 54.5 (SD 7.3) out of 80. Nurses with higher STS scores were more likely to report medical errors (odds ratio (OR) = 1.05; 95% confidence interval (CI) = 1.02-1.08) and were less likely to be involved in the occurrence of adverse events (OR = 0.96; 95% CI = 0.93-0.98). Nurses showed moderate systems thinking competency. Systems thinking was a significant factor associated with patient safety. Impact Statement: The findings of this study highlight the importance of enhancing nurses' systems thinking capacity to promote patient safety.

  3. Development of an online morbidity, mortality, and near-miss reporting system to identify patterns of adverse events in surgical patients.

    Science.gov (United States)

    Bilimoria, Karl Y; Kmiecik, Thomas E; DaRosa, Debra A; Halverson, Amy; Eskandari, Mark K; Bell, Richard H; Soper, Nathaniel J; Wayne, Jeffrey D

    2009-04-01

    To design a Web-based system to track adverse and near-miss events, to establish an automated method to identify patterns of events, and to assess the adverse event reporting behavior of physicians. A Web-based system was designed to collect physician-reported adverse events including weekly Morbidity and Mortality (M&M) entries and anonymous adverse/near-miss events. An automated system was set up to help identify event patterns. Adverse event frequency was compared with hospital databases to assess reporting completeness. A metropolitan tertiary care center. Identification of adverse event patterns and completeness of reporting. From September 2005 to August 2007, 15,524 surgical patients were reported including 957 (6.2%) adverse events and 34 (0.2%) anonymous reports. The automated pattern recognition system helped identify 4 event patterns from M&M reports and 3 patterns from anonymous/near-miss reporting. After multidisciplinary meetings and expert reviews, the patterns were addressed with educational initiatives, correction of systems issues, and/or intensive quality monitoring. Only 25% of complications and 42% of inpatient deaths were reported. A total of 75.2% of adverse events resulting in permanent disability or death were attributed to the nature of the disease. Interventions to improve reporting were largely unsuccessful. We have developed a user-friendly Web-based system to track complications and identify patterns of adverse events. Underreporting of adverse events and attributing the complication to the nature of the disease represent a problem in reporting culture among surgeons at our institution. Similar systems should be used by surgery departments, particularly those affiliated with teaching hospitals, to identify quality improvement opportunities.

  4. Nova Event Logging System

    International Nuclear Information System (INIS)

    Calliger, R.J.; Suski, G.J.

    1981-01-01

    Nova is a 200 terawatt, 10-beam High Energy Glass Laser currently under construction at LLNL. This facility, designed to demonstrate the feasibility of laser driven inertial confinement fusion, contains over 5000 elements requiring coordinated control, data acquisition, and analysis functions. The large amounts of data that will be generated must be maintained over the life of the facility. Often the most useful but inaccessible data is that related to time dependent events associated with, for example, operator actions or experiment activity. We have developed an Event Logging System to synchronously record, maintain, and analyze, in part, this data. We see the system as being particularly useful to the physics and engineering staffs of medium and large facilities in that it is entirely separate from experimental apparatus and control devices. The design criteria, implementation, use, and benefits of such a system will be discussed

  5. Developing and Testing the Health Care Safety Hotline: A Prototype Consumer Reporting System for Patient Safety Events.

    Science.gov (United States)

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

    2017-06-01

    This article describes the design, development, and testing of the Health Care Safety Hotline, a prototype consumer reporting system for patient safety events. The prototype was designed and developed with ongoing review by a technical expert panel and feedback obtained during a public comment period. Two health care delivery organizations in one metropolitan area collaborated with the researchers to demonstrate and evaluate the system. The prototype was deployed and elicited information from patients, family members, and caregivers through a website or an 800 phone number. The reports were considered useful and had little overlap with information received by the health care organizations through their usual risk management, customer service, and patient safety monitoring systems. However, the frequency of reporting was lower than anticipated, suggesting that further refinements, including efforts to raise awareness by actively soliciting reports from subjects, might be necessary to substantially increase the volume of useful reports. It is possible that a single technology platform could be built to meet a variety of different patient safety objectives, but it may not be possible to achieve several objectives simultaneously through a single consumer reporting system while also establishing trust with patients, caregivers, and providers.

  6. Abnormal condition and events analysis for instrumentation and control systems. Volume 2: Survey and evaluation of industry practices. Final report

    International Nuclear Information System (INIS)

    McKemy, S.; Marcelli, M.; Boehmer, N.; Crandall, D.

    1996-01-01

    The ACES Project was initiated to identify a cost-effective methodology for addressing abnormal conditions and events (ACES) in digital upgrades to nuclear power plant systems, as introduced by IEEE Standard 7-4.3.2-1993. Several methodologies and techniques currently in use in the defense, aerospace, and other communities for the assurance of digital safety systems were surveyed, and although several were shown to possess desirable qualities, none sufficiently met the needs of the nuclear power industry. This report describes a tailorable methodology for performing ACES analysis that is based on the more desirable aspects of the reviewed methodologies and techniques. The methodology is applicable to both safety- and non-safety-grade systems, addresses hardware, software, and system-level concerns, and can be applied in either a lifecycle or post-design timeframe. Employing this methodology for safety systems should facilitate the digital upgrade licensing process

  7. Licensee Event Report (LER) compilation, December 1991

    International Nuclear Information System (INIS)

    1992-01-01

    This monthly report contains licensee event report (LER) operational information that was processed into the LER data file of the Nuclear Safety Information Center (NSIC) during the one month period identified on the cover of the document. The LERs, from which this information is derived, are submitted to the Nuclear Regulatory Commission (NRC) by nuclear power plant licensees in accordance with federal regulations. Procedures for LER reporting for revisions to those events occurring prior to 1984 are described in NRC Regulatory Guide 1.16 and NUREG-0161, Instructions for Preparation of Data Entry Sheets for Licensee Event Reports. For those events occurring on and after January 1, 1984, LERs are being submitted in accordance with the revised rule contained in Title 10 Part 50.73 of the Code of Federal Regulations (10 CFR 50.73 - Licensee Event Report System) which was published in the Federal Register (Vol. 48, No. 144) on July 26, 1983. NUREG-1022, Licensee Event Report System - Description of Systems and Guidelines for Reporting, provides supporting guidance and information on the revised LER rule

  8. Attitudes and Usage of the Food and Drug Administration Adverse Event Reporting System Among Gastroenterology Nurse Practitioners and Physician Assistants.

    Science.gov (United States)

    Salk, Allison; Ehrenpreis, Eli D

    2016-01-01

    The Food and Drug Administration Adverse Event Reporting System (FAERS) is used for postmarketing pharmacovigilance. Our study sought to assess attitudes and usage of the FAERS among gastroenterology nurse practitioners (NPs) and physician assistants (PAs). A survey was administered at the August 2012 Principles of Gastroenterology for the Nurse Practitioner and Physician Assistant course, held in Chicago, IL. Of the 128 respondents, 123 (96%) reported a specialty in gastroenterology or hepatology and were included in analysis. Eighty-nine participants were NPs and 32 PAs, whereas 2 did not report their profession. Although 119 (98%) agreed or strongly agreed with the statement that accurately reporting adverse drug reactions is an important process to optimize patient safety, the majority of participants (54% NPs and 81% PAs) were unfamiliar with the FAERS. In addition, only 20% of NPs and 9% of PAs reported learning about the FAERS in NP or PA schooling. Our study shows enthusiasm among gastroenterology NPs and PAs for the reporting of adverse drug reactions, coupled with a lack of familiarity with the FAERS. This presents an opportunity for enhanced education about reporting of adverse drug reactions for gastroenterology NPs and PAs.

  9. Acute renal failure with sodium-glucose-cotransporter-2 inhibitors: Analysis of the FDA adverse event report system database.

    Science.gov (United States)

    Perlman, A; Heyman, S N; Matok, I; Stokar, J; Muszkat, M; Szalat, A

    2017-12-01

    Sodium-glucose-cotransporter-2 (SGLT2) inhibitors have recently been approved for the treatment of type II diabetes mellitus (T2DM). It has been proposed that these agents could induce acute renal failure (ARF) under certain conditions. This study aimed to evaluate the association between SGLT2-inhibitors and ARF in the FDA adverse event report system (FAERS) database. We analyzed adverse event cases submitted to FAERS between January 2013 and September 2016. ARF cases were identified using a structured medical query. Medications were identified using both brand and generic names. During the period evaluated, 18,915 reports (out of a total of 3,832,015 registered in FAERS) involved the use of SGLT2-inhibitors. SGLT2-inhibitors were reportedly associated with ARF in 1224 of these cases (6.4%), and were defined as the "primary" or "secondary" cause of the adverse event in 96.8% of these cases. The proportion of reports with ARF among reports with SGLT2 inhibitor was almost three-fold higher compared to reports without these drugs (ROR 2.88, 95% CI 2.71-3.05, p SGLT2-inhibitors was significantly greater than the proportion of ARF among cases with T2DM without SGLT2-inhibitors (ROR 1.68, 95% CI 1.57-1.8, p SGLT2-inhibitors, canagliflozin was associated with a higher proportion of reports of renal failure (7.3%), compared to empagliflozin and dapagliflozin (4.7% and 4.8% respectively, p SGLT2-inhibitors are associated with an increase in the proportion of reports of ARF compared to other medications. SGLT2-inhibitor agents may differ from one another in their respective risk for ARF. Copyright © 2017 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

  10. Hybla Fair event: environmental report

    International Nuclear Information System (INIS)

    Roach, D.R.; Russell, W.L. Jr.

    1975-01-01

    A series of environmental measurements during the Hybla Fair nuclear event were made. Experimenters were unsure of conditions that would be created since there was no closure system and the experiments were close to the source. A variety of temperature, pressure, and load devices were tested. The results will aid in the design and engineering of future close-in diagnostic packages and pipes. (U.S.)

  11. Proton Pump Inhibitors and the Risk for Fracture at Specific Sites: Data Mining of the FDA Adverse Event Reporting System.

    Science.gov (United States)

    Wang, Liwei; Li, Mei; Cao, Yuying; Han, Zhengqi; Wang, Xueju; Atkinson, Elizabeth J; Liu, Hongfang; Amin, Shreyasee

    2017-07-17

    Proton pump inhibitors (PPIs) are widely used to treat gastric acid-related disorders. Concerns have been raised about potential fracture risk, especially at the hip, spine and wrist. However, fracture risk at other bone sites has not been as well studied. We investigated the association between PPIs and specific fracture sites using an aggregated knowledge-enhanced database, the Food and Drug Administration Adverse Event Reporting System Data Mining Set (AERS-DM). Proportional reporting ratio (PRR) was used to detect statistically significant associations (signals) between PPIs and fractures. We analyzed both high level terms (HLT) and preferred terms (PT) for fracture sites, defined by MedDRA (Medical Dictionary for Regulatory Activities). Of PPI users reporting fractures, the mean age was 65.3 years and the female to male ratio was 3.4:1. Results revealed signals at multiple HLT and PT fracture sites, consistent for both sexes. These included fracture sites with predominant trabecular bone, not previously reported as being associated with PPIs, such as 'rib fractures', where signals were detected for overall PPIs as well as for each of 5 generic ingredients (insufficient data for dexlansoprazole). Based on data mining from AERS-DM, PPI use appears to be associated with an increased risk for fractures at multiple sites.

  12. Consumer reporting of adverse events following immunization.

    Science.gov (United States)

    Clothier, Hazel J; Selvaraj, Gowri; Easton, Mee Lee; Lewis, Georgina; Crawford, Nigel W; Buttery, Jim P

    2014-01-01

    Surveillance of adverse events following immunisation (AEFI) is an essential component of vaccine safety monitoring. The most commonly utilized passive surveillance systems rely predominantly on reporting by health care providers (HCP). We reviewed adverse event reports received in Victoria, Australia since surveillance commencement in July 2007, to June 2013 (6 years) to ascertain the contribution of consumer (vaccinee or their parent/guardian) reporting to vaccine safety monitoring and to inform future surveillance system development directions. Categorical data included were: reporter type; serious and non-serious AEFI category; and, vaccinee age group. Chi-square test and 2-sample test of proportions were used to compare categories; trend changes were assessed using linear regression. Consumer reporting increased over the 6 years, reaching 21% of reports received in 2013 (PConsumer reports were 5% more likely to describe serious AEFI than HCP (P=0.018) and 10% more likely to result in specialist clinic attendance (Preporting increased to 32% of all report since its introduction in 2010, 85% of consumers continued to report by phone. Consumer reporting of AEFI is a valuable component of vaccine safety surveillance in addition to HCP reporting. Changes are required to AEFI reporting systems to implement efficient consumer AEFI reporting, but may be justified for their potential impact on signal detection sensitivity.

  13. Impact of an Event Reporting System on Resident Complication Reporting in Plastic Surgery Training: Addressing an ACGME and Plastic Surgery Milestone Project Core Competency.

    Science.gov (United States)

    Parikh, Rajiv P; Snyder-Warwick, Alison; Naidoo, Sybill; Skolnick, Gary B; Patel, Kamlesh B

    2017-11-01

    The Accreditation Council for Graduate Medical Education and Plastic Surgery Milestone Project has identified practice-based learning and improvement, which involves systematically analyzing current practices and implementing changes, as a core competency in residency education. In surgical care, complication reporting is an essential component of practice-based learning and improvement as complications are analyzed in morbidity and mortality conference for quality improvement. Unfortunately, current methods for capturing a comprehensive profile of complications may significantly underestimate the true occurrence of complications. Therefore, the objectives of this study are to evaluate an intervention for complication reporting and compare this to current practice, in a plastic surgery training program. This is a preintervention and postintervention study evaluating resident reporting of complications on a plastic surgery service. The intervention was an online event reporting system developed by department leadership and patient safety experts. The cohorts consisted of all patients undergoing surgery during two separate 3-month blocks bridged by an implementation period. A trained reviewer recorded complications, and this served as the reference standard. Fisher's exact test was used for binary comparisons. There were 32 complications detected in 219 patients from June to August of 2015 and 35 complications in 202 patients from October to December of 2015. The proportion of complications reported in the preintervention group was nine of 32 (28.1 percent). After the intervention, this significantly increased to 32 of 35 (91.4 percent) (p < 0.001). An intervention using an event reporting system, supported by departmental leadership, led to significant improvements in complication reporting by plastic surgery residents.

  14. Development of a Classification Scheme for Examining Adverse Events Associated with Medical Devices, Specifically the DaVinci Surgical System as Reported in the FDA MAUDE Database.

    Science.gov (United States)

    Gupta, Priyanka; Schomburg, John; Krishna, Suprita; Adejoro, Oluwakayode; Wang, Qi; Marsh, Benjamin; Nguyen, Andrew; Genere, Juan Reyes; Self, Patrick; Lund, Erik; Konety, Badrinath R

    2017-01-01

    To examine the Manufacturer and User Facility Device Experience Database (MAUDE) database to capture adverse events experienced with the Da Vinci Surgical System. In addition, to design a standardized classification system to categorize the complications and machine failures associated with the device. Overall, 1,057,000 DaVinci procedures were performed in the United States between 2009 and 2012. Currently, no system exists for classifying and comparing device-related errors and complications with which to evaluate adverse events associated with the Da Vinci Surgical System. The MAUDE database was queried for events reports related to the DaVinci Surgical System between the years 2009 and 2012. A classification system was developed and tested among 14 robotic surgeons to associate a level of severity with each event and its relationship to the DaVinci Surgical System. Events were then classified according to this system and examined by using Chi-square analysis. Two thousand eight hundred thirty-seven events were identified, of which 34% were obstetrics and gynecology (Ob/Gyn); 19%, urology; 11%, other; and 36%, not specified. Our classification system had moderate agreement with a Kappa score of 0.52. Using our classification system, we identified 75% of the events as mild, 18% as moderate, 4% as severe, and 3% as life threatening or resulting in death. Seventy-seven percent were classified as definitely related to the device, 15% as possibly related, and 8% as not related. Urology procedures compared with Ob/Gyn were associated with more severe events (38% vs 26%, p tool with moderate inter-rater agreement that can be used to better understand device-related adverse events. The majority of robotic related events were mild but associated with the device.

  15. 78 FR 9743 - Event Reporting Guidelines

    Science.gov (United States)

    2013-02-11

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0237] Event Reporting Guidelines AGENCY: Nuclear... Regulatory Commission (NRC) has issued NUREG- 1022, Revision 3, ``Event Reporting Guidelines: 10 CFR 50.72 and 50.73.'' [[Page 9744

  16. Report on Fukushima Daiichi NPP precursor events

    International Nuclear Information System (INIS)

    2014-01-01

    The main questions to be answered by this report were: The Fukushima Daiichi NPP accident, could it have been prevented? If there is a next severe accident, may it be prevented? To answer the first question, the report addressed several aspects. First, the report investigated whether precursors to the Fukushima Daiichi NPP accident existed in the operating experience; second, the reasons why these precursors did not evolve into a severe accident. Third, whether lessons learned from these precursor events were adequately considered by member countries; and finally, if the operating experience feedback system needs to be improved, based on the previous analysis. To address the second question which is much more challenging, the report considered precursor events identified through a search and analysis of the IRS database and also precursors events based on risk significance. Both methods can point out areas where further work may be needed, even if it depends heavily on design and site-specific factors. From the operating experience side, more efforts are needed to ensure timely and full implementation of lessons learnt from precursor events. Concerning risk considerations, a combined use of risk precursors and operating experience may drive to effective changes to plants to reduce risk. The report also contains a short description and evaluation of selected precursors that are related to the course of the Fukushima Daiichi NPP accident. The report addresses the question whether operating experience feedback can be effectively used to identify plant vulnerabilities and minimize potential for severe core damage accidents. Based on several of the precursor events national or international in-depth evaluations were started. The vulnerability of NPPs due to external and internal flooding has clearly been addressed. In addition to the IRS based investigation, the WGRISK was asked to identify important precursor events based on risk significance. These precursors have

  17. Retrieval system for emplaced spent unreprocessed fuel (SURF) in salt bed depository: accident event analysis and mechanical failure probabilities. Final report

    International Nuclear Information System (INIS)

    Bhaskaran, G.; McCleery, J.E.

    1979-10-01

    This report provides support in developing an accident prediction event tree diagram, with an analysis of the baseline design concept for the retrieval of emplaced spent unreprocessed fuel (SURF) contained in a degraded Canister. The report contains an evaluation check list, accident logic diagrams, accident event tables, fault trees/event trees and discussions of failure probabilities for the following subsystems as potential contributors to a failure: (a) Canister extraction, including the core and ram units; (b) Canister transfer at the hoist area; and (c) Canister hoisting. This report is the second volume of a series. It continues and expands upon the report Retrieval System for Emplaced Spent Unreprocessed Fuel (SURF) in Salt Bed Depository: Baseline Concept Criteria Specifications and Mechanical Failure Probabilities. This report draws upon the baseline conceptual specifications contained in the first report

  18. 76 FR 63565 - Event Reporting Guidelines

    Science.gov (United States)

    2011-10-13

    ...-2011-0237] Event Reporting Guidelines AGENCY: Nuclear Regulatory Commission. ACTION: Draft NUREG... comments on Draft NUREG-1022, Revision 3, ``Event Reporting Guidelines: 10 CFR 50.72 and 50.73''. The NUREG-1022 contains guidelines that the NRC staff considers acceptable for use in meeting the event reporting...

  19. Event notification system with a PLC

    International Nuclear Information System (INIS)

    Kawase, M.; Yoshikawa, Hiroshi; Sakaki, Hironao; Takahashi, Hiroki; Sako, Hiroyuki; Kamiya, Junichiro; Takayanagi, Tomohiro

    2004-01-01

    When an interlock occurs in the equipment, it is required to notify the upper rank control system of the Interlock and receive information for apparatus information in the upper rank control system as at high speed as possible. In the apparatus using FA-M3, it can respond to this by using the notice function of an event. This report shows the event notification system with a PLC based Kicker electromagnet power supply for 3GeV RCS. (author)

  20. Event Reports for Operating Reactors

    Data.gov (United States)

    Nuclear Regulatory Commission — Raw data of all the events for the last month. Raw data is presented in pipe delimited format. This data set is updated monthly on the first business day of the month.

  1. Contraceptives as possible risk factors for postpartum depression: A retrospective study of the food and drug administration adverse event reporting system, 2004-2015.

    Science.gov (United States)

    Horibe, Megumi; Hane, Yuuki; Abe, Junko; Matsui, Toshinobu; Kato, Yamato; Ueda, Natsumi; Sasaoka, Sayaka; Motooka, Yumi; Hatahira, Haruna; Hasegawa, Shiori; Kinosada, Yasutomi; Hara, Hideaki; Nakamura, Mitsuhiro

    2018-04-01

    Postpartum depression is a mood disorder that commonly affects women during the early postpartum period. The objective of this study was to analyse the association of postpartum depression with drugs (including contraceptive devices and implants) with spontaneously reported adverse events reported in the US Food and Drug Administration Adverse Event Reporting System database. Retrospective study. Reports of postpartum depression events between 2004-2015 were analysed with a reporting odds ratio (ROR) algorithm. The Medical Dictionary for Regulatory Activities was used to identify postpartum depression. The reporting odds ratios (95% confidence intervals, CI) of levonorgestrel (an intrauterine device with progestogen), etonogestrel (a hormonal contraceptive implant), sertraline and drospirenone (an oral contraceptive) were 12.5 (8.7-18.0), 14.0 (8.5-22.8), 12.2 (6.5-23.1) and 5.4 (2.7-10.9) respectively. Among the drugs in the US Food and Drug Administration Adverse Event Reporting System database, the use of contraceptives or an intrauterine device with progestogen might convey risk for postpartum depression.

  2. Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax in the Vaccine Adverse Event Reporting System (VAERS in the United States, 1990‒2015.

    Directory of Open Access Journals (Sweden)

    Pedro L Moro

    2016-07-01

    Full Text Available In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur, was licensed for use in the United States.To assess adverse events (AEs after HDCV reported to the US Vaccine Adverse Event Reporting System (VAERS, a spontaneous reporting surveillance system.We searched VAERS for US reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness, and those suggesting anaphylaxis and Guillain-Barré syndrome (GBS. Physicians reviewed available information and assigned a primary clinical category to each report using MedDRA system organ classes. Empirical Bayesian (EB data mining was used to identify disproportional AE reporting after HDCV.VAERS received 1,611 reports after HDCV; 93 (5.8% were serious. Among all reports, the three most common AEs included pyrexia (18.2%, headache (17.9%, and nausea (16.5%. Among serious reports, four deaths appeared to be unrelated to vaccination.This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies.

  3. Incidence of patient safety events and process-related human failures during intra-hospital transportation of patients: retrospective exploration from the institutional incident reporting system.

    Science.gov (United States)

    Yang, Shu-Hui; Jerng, Jih-Shuin; Chen, Li-Chin; Li, Yu-Tsu; Huang, Hsiao-Fang; Wu, Chao-Ling; Chan, Jing-Yuan; Huang, Szu-Fen; Liang, Huey-Wen; Sun, Jui-Sheng

    2017-11-03

    Intra-hospital transportation (IHT) might compromise patient safety because of different care settings and higher demand on the human operation. Reports regarding the incidence of IHT-related patient safety events and human failures remain limited. To perform a retrospective analysis of IHT-related events, human failures and unsafe acts. A hospital-wide process for the IHT and database from the incident reporting system in a medical centre in Taiwan. All eligible IHT-related patient safety events between January 2010 to December 2015 were included. Incidence rate of IHT-related patient safety events, human failure modes, and types of unsafe acts. There were 206 patient safety events in 2 009 013 IHT sessions (102.5 per 1 000 000 sessions). Most events (n=148, 71.8%) did not involve patient harm, and process events (n=146, 70.9%) were most common. Events at the location of arrival (n=101, 49.0%) were most frequent; this location accounted for 61.0% and 44.2% of events with patient harm and those without harm, respectively (pprocess step was the preparation of the transportation team (n=91, 48.9%). Contributing unsafe acts included perceptual errors (n=14, 7.5%), decision errors (n=56, 30.1%), skill-based errors (n=48, 25.8%), and non-compliance (n=68, 36.6%). Multivariate analysis showed that human failure found in the arrival and hand-off sub-process (OR 4.84, pprocess at the location of arrival and prevent errors other than omissions. Long-term monitoring of IHT-related events is also warranted. © 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.

  4. DESIGNING AN EVENT EXTRACTION SYSTEM

    Directory of Open Access Journals (Sweden)

    Botond BENEDEK

    2017-06-01

    Full Text Available In the Internet world, the amount of information available reaches very high quotas. In order to find specific information, some tools were created that automatically scroll through the existing web pages and update their databases with the latest information on the Internet. In order to systematize the search and achieve a result in a concrete form, another step is needed for processing the information returned by the search engine and generating the response in a more organized form. Centralizing events of a certain type is useful first of all for creating a news service. Through this system we are pursuing a knowledge - events from the Internet documents - extraction system. The system will recognize events of a certain type (weather, sports, politics, text data mining, etc. depending on how it will be trained (the concept it has in the dictionary. These events can be provided to the user, or it can also extract the context in which the event occurred, to indicate the initial form in which the event was embedded.

  5. Post-licensure safety monitoring of quadrivalent human papillomavirus vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2009-2015.

    Science.gov (United States)

    Arana, Jorge E; Harrington, Theresa; Cano, Maria; Lewis, Paige; Mba-Jonas, Adamma; Rongxia, Li; Stewart, Brock; Markowitz, Lauri E; Shimabukuro, Tom T

    2018-03-20

    The Food and Drug Administration (FDA) approved quadrivalent human papillomavirus vaccine (4vHPV) for use in females and males aged 9-26 years, since 2006 and 2009 respectively. We characterized reports to the Vaccine Adverse Event Reporting System (VAERS), a US spontaneous reporting system, in females and males who received 4vHPV vaccination. We searched VAERS for US reports of adverse events (AEs) following 4vHPV from January 2009 through December 2015. Signs and symptoms were coded using Medical Dictionary for Regulatory Activities (MedDRA). We calculated reporting rates and conducted empirical Bayesian data mining to identify disproportional reports. Clinicians reviewed available information, including medical records, and reports of selected pre-specified conditions. VAERS received 19,760 reports following 4vHPV; 60.2% in females, 17.2% in males, and in 22.6% sex was missing. Overall, 94.2% of reports were non-serious; dizziness, syncope and injection site reactions were commonly reported in both males and females. Headache, fatigue and nausea were commonly reported serious AEs. More than 60 million 4vHPV doses were distributed during the study period. Crude AE reporting rates were 327 reports per million 4vHPV doses distributed for all reports, and 19 per million for serious reports. Among 29 verified reports of death, there was no pattern of clustering of deaths by diagnosis, co-morbidities, age, or interval from vaccination to death. No new or unexpected safety concerns or reporting patterns of 4vHPV with clinically important AEs were detected. Safety profile of 4vHPV is consistent with data from pre-licensure trials and postmarketing safety data. Published by Elsevier Ltd.

  6. The LCLS Timing Event System

    Energy Technology Data Exchange (ETDEWEB)

    Dusatko, John; Allison, S.; Browne, M.; Krejcik, P.; /SLAC

    2012-07-23

    The Linac Coherent Light Source requires precision timing trigger signals for various accelerator diagnostics and controls at SLAC-NAL. A new timing system has been developed that meets these requirements. This system is based on COTS hardware with a mixture of custom-designed units. An added challenge has been the requirement that the LCLS Timing System must co-exist and 'know' about the existing SLC Timing System. This paper describes the architecture, construction and performance of the LCLS timing event system.

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

    Science.gov (United States)

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

    2017-04-01

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

  8. Safety of currently licensed hepatitis B surface antigen vaccines in the United States, Vaccine Adverse Event Reporting System (VAERS), 2005-2015.

    Science.gov (United States)

    Haber, Penina; Moro, Pedro L; Ng, Carmen; Lewis, Paige W; Hibbs, Beth; Schillie, Sarah F; Nelson, Noele P; Li, Rongxia; Stewart, Brock; Cano, Maria V

    2018-01-25

    Currently four recombinant hepatitis B (HepB) vaccines are in use in the United States. HepB vaccines are recommended for infants, children and adults. We assessed adverse events (AEs) following HepB vaccines reported to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system. We searched VAERS for reports of AEs following single antigen HepB vaccine and HepB-containing vaccines (either given alone or with other vaccines), from January 2005 - December 2015. We conducted descriptive analyses and performed empirical Bayesian data mining to assess disproportionate reporting. We reviewed serious reports including reports of special interest. VAERS received 20,231 reports following HepB or HepB-containing vaccines: 10,291 (51%) in persons 18 years; for 1485 (7.3%) age was missing. Dizziness and nausea (8.4% each) were the most frequently reported AEs following a single antigen HepB vaccine: fever (23%) and injection site erythema (11%) were most frequent following Hep-containing vaccines. Of the 4444 (22%) reports after single antigen HepB vaccine, 303 (6.8%) were serious, including 45 deaths. Most commonly reported cause of death was Sudden Infant Death Syndrome (197). Most common non-death serious reports following single antigen HepB vaccines among infants aged children aged 1-23 months; infections and infestation (8) among persons age 2-18 years blood and lymphatic systemic disorders; and general disorders and administration site conditions among persons age >18 years. Most common vaccination error following single antigen HepB was incorrect product storage. Review current U.S.-licensed HepB vaccines administered alone or in combination with other vaccines did not reveal new or unexpected safety concerns. Vaccination errors were identified which indicate the need for training and education of providers on HepB vaccine indications and recommendations. Published by Elsevier Ltd.

  9. Licensee Event Report (LER) compilation for month of September 1991

    International Nuclear Information System (INIS)

    1991-10-01

    This monthly report contains Licensee Event Report (LER) operational information that was processed into the LER data file of the Nuclear Safety Information Center (NSIC) during the one month period identified on the cover of the document. The LERs, from which this information is derived, are submitted to the Nuclear Regulatory Commission (NRC) by nuclear power plant licensees in accordance with federal regulations. Procedures for LER reporting for revisions to those events occurring prior to 1984 are described in NRC Regulatory Guide 1.16 and NUREG-0161, Instructions for Preparation of Data Entry Sheets for Licensee Event Reports. For these events occurring on and after January 1, 1984, LERs are being submitted in accordance with the revised rule contained in Title 10 Part 50.73 of the Code of Federal Regulations (10 CFR 50.73 -- Licensee Event Report System) which was published in the Federal Register (Vol. 48, No. 144) on July 26, 1983. NUREG-1022, Licensee Event Report System -- Description of Systems and Guidelines for Reporting, provides supporting guidance and information on the revised LER rule. The LER summaries in this report are arranged alphabetically by facility name and then chronologically by event data for each facility. Component, system, keyword, and component vendor indexes follow the summaries. Vendors are those identified by the utility when the LER form is initiated; the keywords for the component, system, and general keyword indexes are assigned by the computer using correlation tables from the Sequence Coding and Search System

  10. Licensee Event Report (LER) compilation for month of August 1991

    International Nuclear Information System (INIS)

    1991-09-01

    This monthly report contains Licensee Event Report (LER) operational information that was processed into the LER data file of the Nuclear Safety Information Center (NSIC) during the one month period identified on the cover of the document. The LERs, from which this information is derived, are submitted to the Nuclear Regulatory Commission (NRC) by nuclear power plant licensees in accordance with federal regulations. Procedures for LER reporting for revisions to those events occurring prior to 1984 are described in NRC Regulatory Guide 1.16 and NUREG-0161, Instructions for Preparation of Data Entry Sheets for Licensee Event Reports. For those events occurring on and after January 1, 1984, LERs are being submitted in accordance with the revised rule contained in Title 10 Part 50.73 of the Code of Federal Regulations (10 CFR 5.073 -- Licensee Event Report System) which was published in the Federal Register (Vol. 48, No. 144) on July 26, 1983. NUREG-1022, Licensee Event Report System -- Description of Systems and Guidelines for Reporting, provides supporting guidance and information on the revised LER rule. The LER summaries in this report are arranged alphabetically by facility name and then chronologically by event date for each facility. Component, system, keyword, and component vendor indexes follow the summaries. Vendors are those identified by the utility when the LER form is initiated; the keywords for the component, system, and general keyword indexes are assigned by the computer using correlation tables from the Sequence Coding and Search System

  11. Analysis of licensee event reports related to nuclear generating station onsite electrical system malfunctions, 1976-1978

    International Nuclear Information System (INIS)

    Bickel, J.H.; Abbott, E.C.

    1981-07-01

    This report summarizes the evaluation requested by the ACRS of 1177 LERS, submitted over a three year period, which related to onsite electrical system malfunctions. The evaluation was carried out for the purposes of identifying specific failure modes and consequences, evaluating the assumptions used in WASH-1400 on the reliability of electrical equipment, and identifying specific sequences which are significant to plant safety. The analysis performed provides a more specific identification of onsite electrical system failure modes, sequences, and consequences than was established in WASH-1400

  12. Enhanced surveillance of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccines in pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 2011-2015.

    Science.gov (United States)

    Moro, Pedro L; Cragan, Janet; Tepper, Naomi; Zheteyeva, Yenlik; Museru, Oidda; Lewis, Paige; Broder, Karen

    2016-04-29

    In October 2011, the Advisory Committee on Immunization Practices (ACIP) issued updated recommendations that all pregnant women routinely receive a dose of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine. We characterized reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received Tdap after this updated recommendation (2011-2015) and compared the pattern of adverse events (AEs) with the period before the updated recommendation (2005-2010). We searched the VAERS database for reports of AEs in pregnant women who received Tdap vaccine after the routine recommendation (11/01/2011-6/30/2015) and compared it to published data before the routine Tdap recommendation (01/01/2005-06/30/2010). We conducted clinical review of reports and available medical records. The clinical pattern of reports in the post-recommendation period was compared with the pattern before the routine Tdap recommendation. We found 392 reports of Tdap vaccination after the routine recommendation. One neonatal death but no maternal deaths were reported. No maternal or neonatal deaths were reported before the recommendation. We observed an increase in proportion of reports for stillbirths (1.5-2.8%) and injection site reactions/arm pain (4.5-11.9%) after the recommendation compared to the period before the routine recommendation for Tdap during pregnancy. We noted a decrease in reports of spontaneous abortion (16.7-1%). After the 2011 Tdap recommendation, in most reports, vaccination (79%) occurred during the third trimester compared to 4% before the 2011 Tdap recommendation. Twenty-six reports of repeat Tdap were received in VAERS; 13 did not report an AE. One medical facility accounted for 27% of all submitted reports. No new or unexpected vaccine AEs were noted among pregnant women who received Tdap after routine recommendations for maternal Tdap vaccination. Changes in reporting patterns would be expected, given the broader use of

  13. Healthcare professionals and pharmacovigilance of pediatric adverse drug reactions: a 5-year analysis of Adverse Events Reporting System database of the Food and Drug Administration.

    Science.gov (United States)

    Bigi, Caterina; Tuccori, Marco; Bocci, Guido

    2017-02-17

    To analyze the Adverse Events Reporting System (AERS) database of the Food and Drug Administration (FDA), investigating the characteristics of pediatric adverse drug reactions (ADRs) and describing the effective participation of healthcare professionals in the reporting activity. Reports of ADRs were obtained from the FDA website. Only ADRs in pediatric subjects (divided by age, by country and by professional category) were included into the analysis. The drugs suspected as primary cause of the ADRs in pediatric subjects and their principal anatomic group according to the Anatomical Therapeutic Chemical classification system were considered. To classify the ADRs, the Medical Dictionary for Regularity Activities terminology was adopted. Between 2008 and 2012, FDA collected 113,077 ADRs in pediatric patients. Of the total pediatric ADR reports, those performed by medical doctors were 32%, followed by consumers (26%) and healthcare professionals (25%). Most of the ADR reports were related to the adolescent group (39%). Healthcare professionals resulted the category with the highest rate of ADR reports in neonates and infants. Drugs acting on nervous system and antineoplastic/immunomodulating agents were the most involved the pediatric ADR reports. Pyrexia, convulsion, vomiting and accidental overdose were the reactions more reported both from healthcare professionals and medical doctors. The present study describes the pediatric ADR reports of the FDA database through healthcare professional's perspective, describing the various aspects of pediatric pharmacovigilance.

  14. Features, Events, and Processes: System Level

    Energy Technology Data Exchange (ETDEWEB)

    D. McGregor

    2004-04-19

    The primary purpose of this analysis is to evaluate System Level features, events, and processes (FEPs). The System Level FEPs typically are overarching in nature, rather than being focused on a particular process or subsystem. As a result, they are best dealt with at the system level rather than addressed within supporting process-level or subsystem level analyses and models reports. The System Level FEPs also tend to be directly addressed by regulations, guidance documents, or assumptions listed in the regulations; or are addressed in background information used in development of the regulations. This evaluation determines which of the System Level FEPs are excluded from modeling used to support the total system performance assessment for license application (TSPA-LA). The evaluation is based on the information presented in analysis reports, model reports, direct input, or corroborative documents that are cited in the individual FEP discussions in Section 6.2 of this analysis report.

  15. Data-mining for detecting signals of adverse drug reactions of fluoxetine using the Korea Adverse Event Reporting System (KAERS) database.

    Science.gov (United States)

    Kim, Seonji; Park, Kyounghoon; Kim, Mi-Sook; Yang, Bo Ram; Choi, Hyun Jin; Park, Byung-Joo

    2017-10-01

    Selective serotonin reuptake inhibitors (SSRIs) have become one of the most broadly used medications in psychiatry. Fluoxetine is the first representative antidepressant SSRI drug approved by the Food and Drug Administration (FDA) in 1987. Safety information on fluoxetine use alone was less reported than its combined use with other drugs. There were no published papers on adverse drug reactions (ADRs) of fluoxetine analyzing spontaneous adverse events reports. We detected signals of the adverse drug reactions of fluoxetine by data mining using the Korea Adverse Events Reporting System (KAERS) database. We defined signals in this study by the reporting odds ratios (ROR), proportional reporting ratios (PRR), and information components (IC) indices. The KAERS database included 860,224 AE reports, among which 866 reports contained fluoxetine. We compared the labels of fluoxetine among the United States, UK, Germany, France, China, and Korea. Some of the signals, including emotional lability, myositis, spinal stenosis, paradoxical drug reaction, drug dependence, extrapyramidal disorder, adrenal insufficiency, and intracranial hemorrhage, were not labeled in the six countries. In conclusion, we identified new signals that were not known at the time of market approval. However, certain factors should be required for signal evaluation, such as clinical significance, preventability, and causality of the detected signals. Copyright © 2017 Elsevier B.V. All rights reserved.

  16. Evaluation of epidemic intelligence systems integrated in the early alerting and reporting project for the detection of A/H5N1 influenza events.

    Directory of Open Access Journals (Sweden)

    Philippe Barboza

    Full Text Available The objective of Web-based expert epidemic intelligence systems is to detect health threats. The Global Health Security Initiative (GHSI Early Alerting and Reporting (EAR project was launched to assess the feasibility and opportunity for pooling epidemic intelligence data from seven expert systems. EAR participants completed a qualitative survey to document epidemic intelligence strategies and to assess perceptions regarding the systems performance. Timeliness and sensitivity were rated highly illustrating the value of the systems for epidemic intelligence. Weaknesses identified included representativeness, completeness and flexibility. These findings were corroborated by the quantitative analysis performed on signals potentially related to influenza A/H5N1 events occurring in March 2010. For the six systems for which this information was available, the detection rate ranged from 31% to 38%, and increased to 72% when considering the virtual combined system. The effective positive predictive values ranged from 3% to 24% and F1-scores ranged from 6% to 27%. System sensitivity ranged from 38% to 72%. An average difference of 23% was observed between the sensitivities calculated for human cases and epizootics, underlining the difficulties in developing an efficient algorithm for a single pathology. However, the sensitivity increased to 93% when the virtual combined system was considered, clearly illustrating complementarities between individual systems. The average delay between the detection of A/H5N1 events by the systems and their official reporting by WHO or OIE was 10.2 days (95% CI: 6.7-13.8. This work illustrates the diversity in implemented epidemic intelligence activities, differences in system's designs, and the potential added values and opportunities for synergy between systems, between users and between systems and users.

  17. Evaluation of Epidemic Intelligence Systems Integrated in the Early Alerting and Reporting Project for the Detection of A/H5N1 Influenza Events

    Science.gov (United States)

    Barboza, Philippe; Vaillant, Laetitia; Mawudeku, Abla; Nelson, Noele P.; Hartley, David M.; Madoff, Lawrence C.; Linge, Jens P.; Collier, Nigel; Brownstein, John S.; Yangarber, Roman; Astagneau, Pascal; on behalf of the Early Alerting, Reporting Project of the Global Health Security Initiative

    2013-01-01

    The objective of Web-based expert epidemic intelligence systems is to detect health threats. The Global Health Security Initiative (GHSI) Early Alerting and Reporting (EAR) project was launched to assess the feasibility and opportunity for pooling epidemic intelligence data from seven expert systems. EAR participants completed a qualitative survey to document epidemic intelligence strategies and to assess perceptions regarding the systems performance. Timeliness and sensitivity were rated highly illustrating the value of the systems for epidemic intelligence. Weaknesses identified included representativeness, completeness and flexibility. These findings were corroborated by the quantitative analysis performed on signals potentially related to influenza A/H5N1 events occurring in March 2010. For the six systems for which this information was available, the detection rate ranged from 31% to 38%, and increased to 72% when considering the virtual combined system. The effective positive predictive values ranged from 3% to 24% and F1-scores ranged from 6% to 27%. System sensitivity ranged from 38% to 72%. An average difference of 23% was observed between the sensitivities calculated for human cases and epizootics, underlining the difficulties in developing an efficient algorithm for a single pathology. However, the sensitivity increased to 93% when the virtual combined system was considered, clearly illustrating complementarities between individual systems. The average delay between the detection of A/H5N1 events by the systems and their official reporting by WHO or OIE was 10.2 days (95% CI: 6.7–13.8). This work illustrates the diversity in implemented epidemic intelligence activities, differences in system's designs, and the potential added values and opportunities for synergy between systems, between users and between systems and users. PMID:23472077

  18. Evaluation of epidemic intelligence systems integrated in the early alerting and reporting project for the detection of A/H5N1 influenza events.

    Science.gov (United States)

    Barboza, Philippe; Vaillant, Laetitia; Mawudeku, Abla; Nelson, Noele P; Hartley, David M; Madoff, Lawrence C; Linge, Jens P; Collier, Nigel; Brownstein, John S; Yangarber, Roman; Astagneau, Pascal

    2013-01-01

    The objective of Web-based expert epidemic intelligence systems is to detect health threats. The Global Health Security Initiative (GHSI) Early Alerting and Reporting (EAR) project was launched to assess the feasibility and opportunity for pooling epidemic intelligence data from seven expert systems. EAR participants completed a qualitative survey to document epidemic intelligence strategies and to assess perceptions regarding the systems performance. Timeliness and sensitivity were rated highly illustrating the value of the systems for epidemic intelligence. Weaknesses identified included representativeness, completeness and flexibility. These findings were corroborated by the quantitative analysis performed on signals potentially related to influenza A/H5N1 events occurring in March 2010. For the six systems for which this information was available, the detection rate ranged from 31% to 38%, and increased to 72% when considering the virtual combined system. The effective positive predictive values ranged from 3% to 24% and F1-scores ranged from 6% to 27%. System sensitivity ranged from 38% to 72%. An average difference of 23% was observed between the sensitivities calculated for human cases and epizootics, underlining the difficulties in developing an efficient algorithm for a single pathology. However, the sensitivity increased to 93% when the virtual combined system was considered, clearly illustrating complementarities between individual systems. The average delay between the detection of A/H5N1 events by the systems and their official reporting by WHO or OIE was 10.2 days (95% CI: 6.7-13.8). This work illustrates the diversity in implemented epidemic intelligence activities, differences in system's designs, and the potential added values and opportunities for synergy between systems, between users and between systems and users.

  19. Abnormal condition and events analysis for instrumentation and control systems. Volume 1: Methodology for nuclear power plant digital upgrades. Final report

    International Nuclear Information System (INIS)

    McKemy, S.; Marcelli, M.; Boehmer, N.; Crandall, D.

    1996-01-01

    The ACES project was initiated to identify a cost-effective methodology for addressing abnormal conditions and events (ACES) in digital upgrades to nuclear power plant systems, as introduced by IEEE Standard 7-4.3.2-1993. Several methodologies and techniques currently in use in the defense, aerospace, and other communities for the assurance of digital safety systems were surveyed, and although several were shown to possess desirable qualities, non sufficiently met the needs of the nuclear power industry. This report describes a tailorable methodology for performing ACES analysis that is based on the more desirable aspects of the reviewed methodologies and techniques. The methodology is applicable to both safety- and non-safety-grade systems, addresses hardware, software, and system-level concerns, and can be applied in either a lifecycle or post-design timeframe. Employing this methodology for safety systems should facilitate the digital upgrade licensing process

  20. Impact of a reengineered electronic error-reporting system on medication event reporting and care process improvements at an urban medical center.

    Science.gov (United States)

    McKaig, Donald; Collins, Christine; Elsaid, Khaled A

    2014-09-01

    A study was conducted to evaluate the impact of a reengineered approach to electronic error reporting at a 719-bed multidisciplinary urban medical center. The main outcome of interest was the monthly reported medication errors during the preimplementation (20 months) and postimplementation (26 months) phases. An interrupted time series analysis was used to describe baseline errors, immediate change following implementation of the current electronic error-reporting system (e-ERS), and trend of error reporting during postimplementation. Errors were categorized according to severity using the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Medication Error Index classifications. Reported errors were further analyzed by reporter and error site. During preimplementation, the monthly reported errors mean was 40.0 (95% confidence interval [CI]: 36.3-43.7). Immediately following e-ERS implementation, monthly reported errors significantly increased by 19.4 errors (95% CI: 8.4-30.5). The change in slope of reported errors trend was estimated at 0.76 (95% CI: 0.07-1.22). Near misses and no-patient-harm errors accounted for 90% of all errors, while errors that caused increased patient monitoring or temporary harm accounted for 9% and 1%, respectively. Nurses were the most frequent reporters, while physicians were more likely to report high-severity errors. Medical care units accounted for approximately half of all reported errors. Following the intervention, there was a significant increase in reporting of prevented errors and errors that reached the patient with no resultant harm. This improvement in reporting was sustained for 26 months and has contributed to designing and implementing quality improvement initiatives to enhance the safety of the medication use process.

  1. The contribution of the vaccine adverse event text mining system to the classification of possible Guillain-Barré syndrome reports.

    Science.gov (United States)

    Botsis, T; Woo, E J; Ball, R

    2013-01-01

    We previously demonstrated that a general purpose text mining system, the Vaccine adverse event Text Mining (VaeTM) system, could be used to automatically classify reports of an-aphylaxis for post-marketing safety surveillance of vaccines. To evaluate the ability of VaeTM to classify reports to the Vaccine Adverse Event Reporting System (VAERS) of possible Guillain-Barré Syndrome (GBS). We used VaeTM to extract the key diagnostic features from the text of reports in VAERS. Then, we applied the Brighton Collaboration (BC) case definition for GBS, and an information retrieval strategy (i.e. the vector space model) to quantify the specific information that is included in the key features extracted by VaeTM and compared it with the encoded information that is already stored in VAERS as Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms (PTs). We also evaluated the contribution of the primary (diagnosis and cause of death) and secondary (second level diagnosis and symptoms) diagnostic VaeTM-based features to the total VaeTM-based information. MedDRA captured more information and better supported the classification of reports for GBS than VaeTM (AUC: 0.904 vs. 0.777); the lower performance of VaeTM is likely due to the lack of extraction by VaeTM of specific laboratory results that are included in the BC criteria for GBS. On the other hand, the VaeTM-based classification exhibited greater specificity than the MedDRA-based approach (94.96% vs. 87.65%). Most of the VaeTM-based information was contained in the secondary diagnostic features. For GBS, clinical signs and symptoms alone are not sufficient to match MedDRA coding for purposes of case classification, but are preferred if specificity is the priority.

  2. The Contribution of the Vaccine Adverse Event Text Mining System to the Classification of Possible Guillain-Barré Syndrome Reports

    Science.gov (United States)

    Botsis, T.; Woo, E. J.; Ball, R.

    2013-01-01

    Background We previously demonstrated that a general purpose text mining system, the Vaccine adverse event Text Mining (VaeTM) system, could be used to automatically classify reports of an-aphylaxis for post-marketing safety surveillance of vaccines. Objective To evaluate the ability of VaeTM to classify reports to the Vaccine Adverse Event Reporting System (VAERS) of possible Guillain-Barré Syndrome (GBS). Methods We used VaeTM to extract the key diagnostic features from the text of reports in VAERS. Then, we applied the Brighton Collaboration (BC) case definition for GBS, and an information retrieval strategy (i.e. the vector space model) to quantify the specific information that is included in the key features extracted by VaeTM and compared it with the encoded information that is already stored in VAERS as Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms (PTs). We also evaluated the contribution of the primary (diagnosis and cause of death) and secondary (second level diagnosis and symptoms) diagnostic VaeTM-based features to the total VaeTM-based information. Results MedDRA captured more information and better supported the classification of reports for GBS than VaeTM (AUC: 0.904 vs. 0.777); the lower performance of VaeTM is likely due to the lack of extraction by VaeTM of specific laboratory results that are included in the BC criteria for GBS. On the other hand, the VaeTM-based classification exhibited greater specificity than the MedDRA-based approach (94.96% vs. 87.65%). Most of the VaeTM-based information was contained in the secondary diagnostic features. Conclusion For GBS, clinical signs and symptoms alone are not sufficient to match MedDRA coding for purposes of case classification, but are preferred if specificity is the priority. PMID:23650490

  3. Licensee Event Report (LER) compilation for month of October 1990

    International Nuclear Information System (INIS)

    1990-11-01

    This monthly report contains Licensee Event Report (LER) operational information that was processed into the LER data file of Nuclear Safety Information Center (NSIC) during the one month period identified on the cover of the document. The LERs, from which this information is derived, are submitted to the Nuclear Regulatory Commission (NRC) by nuclear power plant licensees in accordance with federal regulations. Procedures for LER reporting for revisions to those events occurring prior to 1984 are described in NRC Regulatory Guide 1.16 and NUREG-0161, Instructions for Preparation of Data Entry Sheets for Licensee Event Reports. For those events occurring on and after January 1, 1984, LERs are being submitted in accordance with the revised rule contained in Title 10 Part 50.73 of the Code of Federal Regulations (10 CFR 50.73 -- Licensee Event Report System) which was published in the Federal Register (Vol. 48, No. 144) on July 26, 1983.NUREG-1022, Licensee Event Report System -- Description of Systems and Guidelines for Reporting, provides supporting guidance and information on the revised LER rule

  4. Licensee Event Report (LER) compilation for month of October 1988

    International Nuclear Information System (INIS)

    1988-11-01

    This monthly report contains Licensee Event Report (LER) operational information that was processed into the LER data file of the Nuclear Safety Information Center (NSIC) during the one month period identified on the cover of the document. The LERs, from which this information is derived, are submitted to the Nuclear Regulatory Commission (NRC) by nuclear power plant licensees in accordance with federal regulations. Procedures for LER reporting for revisions to those events occurring prior to 1984 are described in NRC Regulatory Guide 1.16 and NUREG-1061, Instructions for Preparation of Data Entry Sheets for Licensee Event Reports. For those events occurring on and after January 1, 1984, LERs are being submitted in accordance with the revised rule contained in Title 10 Part 50.73 of the Code of Federal Regulations (10 CFR 50.73--Licensee Event Report System) which was published in the Federal Register (Vol. 48, No. 144) on July 26, 1983. NUREG-1022, Licensee Event Report System--Description of Systems and Guidelines for Reporting, provides supporting guidance and information on the revised LER rule

  5. Licensee Event Report (LER) compilation for month of August 1990

    International Nuclear Information System (INIS)

    1990-09-01

    This monthly report contains Licensee Event Report (LER) operational information that was processed into the LER data file of the Nuclear Safety Information Center (NSIC) during the one month period identified on the cover of the document. The LERs, from which this information is derived, are submitted to the Nuclear Regulatory Commission (NRC) by nuclear power plant licensees in accordance with federal regulations. Procedures for LER reporting for revisions to those events occurring prior to 1984 are described in NRC Regulatory Guide 1.16 and NUREG-0161, Instructions for Preparation of Data Entry Sheets for Licensee Event Reports. For those events occurring on and after January 1, 1984, LERs are being submitted in accordance with the revised rule contained in Title 10 Part 50.73 of the Code of Federal Regulations (10 CFR 50.73 -- Licensee Event Report System) which was published in the Federal Register (Vol. 48, No. 144) on July 26, 1983. NUREG-1022, Licensee Event Report System -- Description of Systems and Guidelines for Reporting, provides supporting guidance and information on the revised LER rule

  6. Licensee Event Report (LER) compilation for month of March 1988

    International Nuclear Information System (INIS)

    1988-04-01

    This monthly report contains Licensee Event Report (LER) operational information that was processed into the LER data file of the Nuclear Safety Information Center (NSIC) during the one-month period identified on the cover of the document. The LERS, from which this information is derived, are submitted to the Nuclear Regulatory Commission (NRC) by nuclear power plant licensees in accordance with federal regulations. Procedures for LER reporting for revisions to those events occurring prior to 1984 are described in NRC Regulatory Guide 1.16 and NUREG-1061, Instructions for preparation of data entry sheets for licensee event reports. For those events occurring on and after January 1, 1984, LERs are being submitted in accordance with the revised rule contained in Title 10 Part 50.73 of the Code of Federal Regulations (10 CFR 50.73 - Licensee Event Report System) which was published in the Federal Register (Vol. 48, No. 144) on July 26, 1983. NUREG-1022, Licensee Event Report System - Description of systems and guidelines for reporting, provides supporting guidance and information on the revised LER rule

  7. Licensee Event Report (LER) compilation for month of August 1989

    International Nuclear Information System (INIS)

    1989-09-01

    This monthly report contains Licensee Event Report (LER) operational information that was processed into the LER data file of the Nuclear Safety Information Center (NSIC) during the one month period identified on the cover of the document. The LERs, from which this information is derived, are submitted to the Nuclear Regulatory Commission (NRC) by nuclear power plant licensees in accordance with federal regulations. Procedures for LER reporting for revisions to these events occurring prior to 1984 are described in NRC Regulatory Guide 1.16 and NUREG-0161, Instructions for Preparation of Data Entry Sheets for Licensee Event Reports. For those events occurring on and after January 1, 1984, LERs are being submitted in accordance with the revised rule contained in Title 10 Part 50.73 of the Code of Federal Regulations (10 CFR 50.73 -- Licensee Event Report System) which was published in the Federal Register (Vol. 48, No. 144) on July 26, 1983. NUREG-1022, Licensee Event Report System -- Description of Systems and Guidelines for Reporting, provides supporting guidance and information on the revised LER rule

  8. Assessing the association between omalizumab and arteriothrombotic events through spontaneous adverse event reporting.

    Science.gov (United States)

    Ali, Ayad K; Hartzema, Abraham G

    2012-01-01

    Omalizumab is a monoclonal antibody, indicated for the treatment of severe allergic asthma. In Europe, there have been concerns about the cardiovascular safety of omalizumab. The objective of this study was to analyze the association between omalizumab and arterial thrombotic events in a spontaneous adverse drug reaction reporting database in the US. Reports of arterial thrombotic events submitted to the US Food and Drug Administration's Adverse Event Reporting System (AERS) between 2004 and 2011 were retrieved and analyzed by the reporting odds ratio data mining algorithm. The reporting odds ratio of arterial thrombotic events for omalizumab was compared with specific asthma medications and all drugs in the AERS. Values ≥2 were considered significant safety signals. The Medical Dictionary for Regulatory Activities Preferred Terms were used to identify arterial thrombotic events (eg, stroke, myocardial infarction). In total, 293,783 reports of arterial thrombotic events were retrieved (about 2% of all adverse drug reaction reports), corresponding to 2274 asthma drug-arterial thrombotic events pairs (omalizumab, 222; inhaled corticosteroids [ICS], 131; long-acting beta-agonists [LABA], 102; single-device combination ICS-LABA, 506; inhaled short-acting beta-agonists [SABA], 475; oral SABA, 6; inhaled antimuscarinics [AMC], 477; single-device combination AMC-SABA, 127; xanthines, 50; leukotriene modifiers, 174; and mast cell stabilizers, 4). Reporting odds ratio and 95% confidence interval values for omalizumab compared with other asthma drugs and all drugs in AERS were 2.75 (2.39-316) and 1.09 (0.95-1.24), respectively. Omalizumab ranked second after ICS in the risk of arterial thrombotic events, followed by AMC, AMC-SABA, and ICS-LABA. Omalizumab is associated with higher than expected reporting of arterial thrombotic events in asthmatic patients. This hypothesis needs further testing in robust epidemiological studies.

  9. ENGINEERED BARRIER SYSTEM FEATURES, EVENTS AND PROCESSES

    Energy Technology Data Exchange (ETDEWEB)

    Jaros, W.

    2005-08-30

    The purpose of this report is to evaluate and document the inclusion or exclusion of engineered barrier system (EBS) features, events, and processes (FEPs) with respect to models and analyses used to support the total system performance assessment for the license application (TSPA-LA). A screening decision, either Included or Excluded, is given for each FEP along with the technical basis for exclusion screening decisions. This information is required by the U.S. Nuclear Regulatory Commission (NRC) at 10 CFR 63.114 (d, e, and f) [DIRS 173273]. The FEPs addressed in this report deal with those features, events, and processes relevant to the EBS focusing mainly on those components and conditions exterior to the waste package and within the rock mass surrounding emplacement drifts. The components of the EBS are the drip shield, waste package, waste form, cladding, emplacement pallet, emplacement drift excavated opening (also referred to as drift opening in this report), and invert. FEPs specific to the waste package, cladding, and drip shield are addressed in separate FEP reports: for example, ''Screening of Features, Events, and Processes in Drip Shield and Waste Package Degradation'' (BSC 2005 [DIRS 174995]), ''Clad Degradation--FEPs Screening Arguments (BSC 2004 [DIRS 170019]), and Waste-Form Features, Events, and Processes'' (BSC 2004 [DIRS 170020]). For included FEPs, this report summarizes the implementation of the FEP in the TSPA-LA (i.e., how the FEP is included). For excluded FEPs, this analysis provides the technical basis for exclusion from TSPA-LA (i.e., why the FEP is excluded). This report also documents changes to the EBS FEPs list that have occurred since the previous versions of this report. These changes have resulted due to a reevaluation of the FEPs for TSPA-LA as identified in Section 1.2 of this report and described in more detail in Section 6.1.1. This revision addresses updates in Yucca Mountain Project

  10. ENGINEERED BARRIER SYSTEM FEATURES, EVENTS AND PROCESSES

    International Nuclear Information System (INIS)

    Jaros, W.

    2005-01-01

    The purpose of this report is to evaluate and document the inclusion or exclusion of engineered barrier system (EBS) features, events, and processes (FEPs) with respect to models and analyses used to support the total system performance assessment for the license application (TSPA-LA). A screening decision, either Included or Excluded, is given for each FEP along with the technical basis for exclusion screening decisions. This information is required by the U.S. Nuclear Regulatory Commission (NRC) at 10 CFR 63.114 (d, e, and f) [DIRS 173273]. The FEPs addressed in this report deal with those features, events, and processes relevant to the EBS focusing mainly on those components and conditions exterior to the waste package and within the rock mass surrounding emplacement drifts. The components of the EBS are the drip shield, waste package, waste form, cladding, emplacement pallet, emplacement drift excavated opening (also referred to as drift opening in this report), and invert. FEPs specific to the waste package, cladding, and drip shield are addressed in separate FEP reports: for example, ''Screening of Features, Events, and Processes in Drip Shield and Waste Package Degradation'' (BSC 2005 [DIRS 174995]), ''Clad Degradation--FEPs Screening Arguments (BSC 2004 [DIRS 170019]), and Waste-Form Features, Events, and Processes'' (BSC 2004 [DIRS 170020]). For included FEPs, this report summarizes the implementation of the FEP in the TSPA-LA (i.e., how the FEP is included). For excluded FEPs, this analysis provides the technical basis for exclusion from TSPA-LA (i.e., why the FEP is excluded). This report also documents changes to the EBS FEPs list that have occurred since the previous versions of this report. These changes have resulted due to a reevaluation of the FEPs for TSPA-LA as identified in Section 1.2 of this report and described in more detail in Section 6.1.1. This revision addresses updates in Yucca Mountain Project (YMP) administrative procedures as they

  11. Assessing the association between omalizumab and arteriothrombotic events through spontaneous adverse event reporting

    Directory of Open Access Journals (Sweden)

    Ali AK

    2012-05-01

    Full Text Available Ayad K Ali, Abraham G HartzemaDepartment of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USABackground: Omalizumab is a monoclonal antibody, indicated for the treatment of severe allergic asthma. In Europe, there have been concerns about the cardiovascular safety of omalizumab. The objective of this study was to analyze the association between omalizumab and arterial thrombotic events in a spontaneous adverse drug reaction reporting database in the US.Methods and materials: Reports of arterial thrombotic events submitted to the US Food and Drug Administration's Adverse Event Reporting System (AERS between 2004 and 2011 were retrieved and analyzed by the reporting odds ratio data mining algorithm. The reporting odds ratio of arterial thrombotic events for omalizumab was compared with specific asthma medications and all drugs in the AERS. Values ≥2 were considered significant safety signals. The Medical Dictionary for Regulatory Activities Preferred Terms were used to identify arterial thrombotic events (eg, stroke, myocardial infarction.Results: In total, 293,783 reports of arterial thrombotic events were retrieved (about 2% of all adverse drug reaction reports, corresponding to 2274 asthma drug-arterial thrombotic events pairs (omalizumab, 222; inhaled corticosteroids [ICS], 131; long-acting beta-agonists [LABA], 102; single-device combination ICS-LABA, 506; inhaled short-acting beta-agonists [SABA], 475; oral SABA, 6; inhaled antimuscarinics [AMC], 477; single-device combination AMC-SABA, 127; xanthines, 50; leukotriene modifiers, 174; and mast cell stabilizers, 4. Reporting odds ratio and 95% confidence interval values for omalizumab compared with other asthma drugs and all drugs in AERS were 2.75 (2.39–316 and 1.09 (0.95–1.24, respectively. Omalizumab ranked second after ICS in the risk of arterial thrombotic events, followed by AMC, AMC-SABA, and ICS-LABA.Conclusion: Omalizumab is

  12. Identification of a Syndrome Class of Neuropsychiatric Adverse Reactions to Mefloquine from Latent Class Modeling of FDA Adverse Event Reporting System Data.

    Science.gov (United States)

    Nevin, Remington L; Leoutsakos, Jeannie-Marie

    2017-03-01

    Although mefloquine use is known to be associated with a risk of severe neuropsychiatric adverse reactions that are often preceded by prodromal symptoms, specific combinations of neurologic or psychiatric reactions associated with mefloquine use are not well described in the literature. This study sought to identify a distinct neuropsychiatric syndrome class associated with mefloquine use in reports of adverse events. Latent class modeling of US Food and Drug Administration Adverse Event Reporting System (FAERS) data was performed using indicators defined by the Medical Dictionary for Regulatory Activities neurologic and psychiatric high-level group terms, in a study dataset of FAERS reports (n = 5332) of reactions to common antimalarial drugs. A distinct neuropsychiatric syndrome class was identified that was strongly and significantly associated with reports of mefloquine use (odds ratio = 3.92, 95% confidence interval 2.91-5.28), defined by a very high probability of symptoms of deliria (82.7%) including confusion and disorientation, and a moderate probability of other severe psychiatric and neurologic symptoms including dementia and amnesia (18.6%) and seizures (18.1%). The syndrome class was also associated with symptoms that are considered prodromal including anxiety, depression, sleep disturbance, and abnormal dreams, and neurological symptoms such as dizziness, vertigo, and paresthesias. This study confirms in FAERS reports the existence of a severe mefloquine neuropsychiatric syndrome class associated with common symptoms that may be considered prodromal. Clinical identification of the characteristic symptoms of this syndrome class may aid in improving case finding in pharmacovigilance studies of more serious adverse reactions to the drug.

  13. Report on the events of September 28, 2003 culminating in the separation of the Italian power system from the other UCTE networks

    International Nuclear Information System (INIS)

    2004-01-01

    the events and the type and quality of information exchanged among the parties concerned (TSOs and Swiss electric utilities), both before and during the events. Subsequently, SFOE failed to deliver any information, either written or verbal, and proposed adopting the UCTE interim report, issued by UCTE on October 27, as the sole source of information for the investigation concerning the Swiss transmission grids. Furthermore, SFOE required the French and Italian TSOs and the integrated Swiss electricity companies to take part in the inquiry. AEEG and CRE could therefore not agree on the organisation of the investigation proposed by SFOE: they believed that the aforementioned participation was not compatible with the necessary independence of their inquiry. Moreover, on November 20, SFOE independently and unilaterally issued a Report on the black-out in Italy on September 28, 2003, without previously consulting AEEG and CRE. Following the afore mentioned unilateral position AEEG and CRE therefore decided to continue the investigation without SFOE and, in a letter dated December 1, signed by respective Directors of AEEG and CRE, invited the integrated Swiss electricity companies directly to provide the same information already requested and obtained from the Italian and French TSOs. In a letter from Swiss Electric dated December 23, the integrated Swiss electricity companies refused to submit information to the regulators' enquiry and stated that all relevant information had already been released for other investigations (e.g., UCTE investigation, SFOE investigation and Italian Government investigation). In spite of the absence of data from the Swiss parties, the amount and quality of information gathered from the Italian and French TSOs however enabled AEEG and CRE to reach a good and fair understanding of the events and the operational procedures jointly adopted by all the system operators involved. The information retrieved by AEEG and CRE also provided a mean of

  14. The Advanced Photon Source event system

    International Nuclear Information System (INIS)

    Lenkszus, F.R.; Laird, R.

    1995-01-01

    The Advanced Photon Source, like many other facilities, requires a means of transmitting timing information to distributed control system 1/0 controllers. The APS event system provides the means of distributing medium resolution/accuracy timing events throughout the facility. It consists of VME event generators and event receivers which are interconnected with 10OMbit/sec fiber optic links at distances of up to 650m in either a star or a daisy chain configuration. The systems event throughput rate is 1OMevents/sec with a peak-to-peak timing jitter down to lOOns depending on the source of the event. It is integrated into the EPICS-based A.PS control system through record and device support. Event generators broadcast timing events over fiber optic links to event receivers which are programmed to decode specific events. Event generators generate events in response to external inputs, from internal programmable event sequence RAMS, and from VME bus writes. The event receivers can be programmed to generate both pulse and set/reset level outputs to synchronize hardware, and to generate interrupts to initiate EPICS record processing. In addition, each event receiver contains a time stamp counter which is used to provide synchronized time stamps to EPICS records

  15. Event Registration System for INR Linac

    International Nuclear Information System (INIS)

    Grekhov, O.V.; Drugakov, A.N.; Kiselev, Yu.V.

    2006-01-01

    The software of the Event registration system for the linear accelerators is described. This system allows receiving of the information on changes of operating modes of the accelerator and supervising of hundreds of key parameters of various systems of the accelerator. The Event registration system consists of the source and listeners of events. The sources of events are subroutines built in existing ACS Linac. The listeners of events are software Supervisor and Client ERS. They are used for warning the operator about change controlled parameter of the accelerator

  16. Features, Events, and Processes: system Level

    Energy Technology Data Exchange (ETDEWEB)

    D. McGregor

    2004-10-15

    The purpose of this analysis report is to evaluate and document the inclusion or exclusion of the system-level features, events, and processes (FEPs) with respect to modeling used to support the total system performance assessment for the license application (TSPA-LA). A screening decision, either Included or Excluded, is given for each FEP along with the technical basis for screening decisions. This information is required by the U.S. Nuclear Regulatory Commission (NRC) at 10 CFR 63.113 (d, e, and f) (DIRS 156605). The system-level FEPs addressed in this report typically are overarching in nature, rather than being focused on a particular process or subsystem. As a result, they are best dealt with at the system level rather than addressed within supporting process-level or subsystem-level analyses and models reports. The system-level FEPs also tend to be directly addressed by regulations, guidance documents, or assumptions listed in the regulations; or are addressed in background information used in development of the regulations. For included FEPs, this analysis summarizes the implementation of the FEP in the TSPA-LA (i.e., how the FEP is included). For excluded FEPs, this analysis provides the technical basis for exclusion from the TSPA-LA (i.e., why the FEP is excluded). The initial version of this report (Revision 00) was developed to support the total system performance assessment for site recommendation (TSPA-SR). This revision addresses the license application (LA) FEP List (DIRS 170760).

  17. Features, Events, and Processes: system Level

    International Nuclear Information System (INIS)

    D. McGregor

    2004-01-01

    The purpose of this analysis report is to evaluate and document the inclusion or exclusion of the system-level features, events, and processes (FEPs) with respect to modeling used to support the total system performance assessment for the license application (TSPA-LA). A screening decision, either Included or Excluded, is given for each FEP along with the technical basis for screening decisions. This information is required by the U.S. Nuclear Regulatory Commission (NRC) at 10 CFR 63.113 (d, e, and f) (DIRS 156605). The system-level FEPs addressed in this report typically are overarching in nature, rather than being focused on a particular process or subsystem. As a result, they are best dealt with at the system level rather than addressed within supporting process-level or subsystem-level analyses and models reports. The system-level FEPs also tend to be directly addressed by regulations, guidance documents, or assumptions listed in the regulations; or are addressed in background information used in development of the regulations. For included FEPs, this analysis summarizes the implementation of the FEP in the TSPA-LA (i.e., how the FEP is included). For excluded FEPs, this analysis provides the technical basis for exclusion from the TSPA-LA (i.e., why the FEP is excluded). The initial version of this report (Revision 00) was developed to support the total system performance assessment for site recommendation (TSPA-SR). This revision addresses the license application (LA) FEP List (DIRS 170760)

  18. An Event Reporting and Early-Warning Safety System Based on the Internet of Things for Underground Coal Mines: A Case Study

    Directory of Open Access Journals (Sweden)

    Byung Wan Jo

    2017-09-01

    Full Text Available Fatal accidents associated with underground coal mines require the implementation of high-level gas monitoring and miner’s localization approaches to promote underground safety and health. This study introduces a real-time monitoring, event-reporting and early-warning platform, based on cluster analysis for outlier detection, spatiotemporal statistical analysis, and an RSS range-based weighted centroid localization algorithm for improving safety management and preventing accidents in underground coal mines. The proposed platform seamlessly integrates monitoring, analyzing, and localization approaches using the Internet of Things (IoT, cloud computing, a real-time operational database, application gateways, and application program interfaces. The prototype has been validated and verified at the operating underground Hassan Kishore coal mine. Sensors for air quality parameters including temperature, humidity, CH4, CO2, and CO demonstrated an excellent performance, with regression constants always greater than 0.97 for each parameter when compared to their commercial equivalent. This framework enables real-time monitoring, identification of abnormal events (>90%, and verification of a miner’s localization (with <1.8 m of error in the harsh environment of underground mines. The main contribution of this study is the development of an open source, customizable, and cost-effective platform for effectively promoting underground coal mine safety. This system is helpful for solving the problems of accessibility, serviceability, interoperability, and flexibility associated with safety in coal mines.

  19. Experience feedback from event reports: the human contribution

    International Nuclear Information System (INIS)

    Swaton, E.; Tolstykh, V.

    1990-01-01

    Analysis of reported events reveals that in a large number of areas human intervention contributed to the initiation and/or development of these events. Since an accident at any nuclear power plant can have a world-wide effect on public acceptance, the need for attentive and reliable human behavior assumes an even greater significance. The identification of areas where human interaction can have an impact on safe operation is mainly relying on the analysis of events reported to the nuclear community. Any substantial compilation of safety significant operational events such as contained in the IAEA-IRS (Incident Reporting System) is bound to provide valuable and factual insights into problem areas, their origin, development, impact and some remedial actions. Thus a systematic analysis has been carried out on over 200 events where a human contribution could be identified. Some events of particular interest will be discussed and furthermore generic lessons will be presented. In addition the Assessment of Safety Significant Event Technique (ASSET) developed within IAEA which provides a structured methodology to identify not only the direct cause explaining why an individual failed but more important, insights on the root causes explaining why this latent deficiency was not detected earlier through the plant surveillance programme was applied. (author)

  20. ENGINEERED BARRIER SYSTEM FEATURES, EVENTS, AND PROCESSES

    International Nuclear Information System (INIS)

    2005-01-01

    This analysis report is one of the technical reports containing documentation of the Environmental Radiation Model for Yucca Mountain, Nevada (ERMYN), a biosphere model supporting the total system performance assessment (TSPA) for the license application (LA) for the Yucca Mountain repository. This analysis report describes the development of biosphere dose conversion factors (BDCFs) for the volcanic ash exposure scenario, and the development of dose factors for calculating inhalation dose during volcanic eruption. A graphical representation of the documentation hierarchy for the ERMYN is presented in Figure 1 - 1. This figure shows the interrelationships among the products (i.e., analysis and model reports) developed for biosphere modeling and provides an understanding of how this analysis report contributes to biosphere modeling. This report is one of two reports that develop biosphere BDCFs, which are input parameters for the TSPA model. The ''Biosphere Model Report'' (BSC 2004 [DIRS 169460]) describes in detail the ERMYN conceptual model and mathematical model. The input parameter reports, shown to the right of the Biosphere Model Report in Figure 1-1, contain detailed descriptions of the model input parameters, their development and the relationship between the parameters and specific features, events and processes (FEPs). This report describes biosphere model calculations and their output, the BDCFs, for the volcanic ash exposure scenario. This analysis receives direct input from the outputs of the ''Biosphere Model Report'' (BSC 2004 [DIRS 169460]) and from the five analyses that develop parameter values for the biosphere model (BSC 2005 [DIRS 172827]; BSC 2004 [DIRS 169672]; BSC 2004 [DIRS 169673]; BSC 2004 [DIRS 169458]; and BSC 2004 [DIRS 169459]). The results of this report are further analyzed in the ''Biosphere Dose Conversion Factor Importance and Sensitivity Analysis'' (Figure 1 - 1). The objective of this analysis was to develop the BDCFs for the

  1. Surface Management System Departure Event Data Analysis

    Science.gov (United States)

    Monroe, Gilena A.

    2010-01-01

    This paper presents a data analysis of the Surface Management System (SMS) performance of departure events, including push-back and runway departure events.The paper focuses on the detection performance, or the ability to detect departure events, as well as the prediction performance of SMS. The results detail a modest overall detection performance of push-back events and a significantly high overall detection performance of runway departure events. The overall detection performance of SMS for push-back events is approximately 55%.The overall detection performance of SMS for runway departure events nears 100%. This paper also presents the overall SMS prediction performance for runway departure events as well as the timeliness of the Aircraft Situation Display for Industry data source for SMS predictions.

  2. Serious adverse events with infliximab: analysis of spontaneously reported adverse events.

    Science.gov (United States)

    Hansen, Richard A; Gartlehner, Gerald; Powell, Gregory E; Sandler, Robert S

    2007-06-01

    Serious adverse events such as bowel obstruction, heart failure, infection, lymphoma, and neuropathy have been reported with infliximab. The aims of this study were to explore adverse event signals with infliximab by using a long period of post-marketing experience, stratifying by indication. The relative reporting of infliximab adverse events to the U.S. Food and Drug Administration (FDA) was assessed with the public release version of the adverse event reporting system (AERS) database from 1968 to third quarter 2005. On the basis of a systematic review of adverse events, Medical Dictionary for Regulatory Activities (MedDRA) terms were mapped to predefined categories of adverse events, including death, heart failure, hepatitis, infection, infusion reaction, lymphoma, myelosuppression, neuropathy, and obstruction. Disproportionality analysis was used to calculate the empiric Bayes geometric mean (EBGM) and corresponding 90% confidence intervals (EB05, EB95) for adverse event categories. Infliximab was identified as the suspect medication in 18,220 reports in the FDA AERS database. We identified a signal for lymphoma (EB05 = 6.9), neuropathy (EB05 = 3.8), infection (EB05 = 2.9), and bowel obstruction (EB05 = 2.8). The signal for granulomatous infections was stronger than the signal for non-granulomatous infections (EB05 = 12.6 and 2.4, respectively). The signals for bowel obstruction and infusion reaction were specific to patients with IBD; this suggests potential confounding by indication, especially for bowel obstruction. In light of this additional evidence of risk of lymphoma, neuropathy, and granulomatous infections, clinicians should stress this risk in the shared decision-making process.

  3. Reports about Occurrence of Events with Effect on Aviation Safety

    Directory of Open Access Journals (Sweden)

    Vladimír Plos

    2014-07-01

    Full Text Available This article deals with a system, that is established to report the events with effect on safety. This system is based on requirements published in Annex 13 to the Chicago Convention and legislative foundations laid down in Regulation L13, Regulation of the European Parliament and of the Council (EU No 376/2014, Decree No. 359/2006 Sb. and Act No. 49/1997 Sb. Standards and legislative rules precisely define the types of events that are subject of reporting and also define the structure and content of the reporting message. This content is consists mainly of the identification data about the airplane and crew, information about the route and a short description of the damage to the airplane. In the following, we discuss the possible use of such a system of mandatory reporting for the needs of safety indicators. Then there are proposals of changes in the content of the reporting message for the need of safety indicators. The present knowledge indicates that the use of all opportunities provided by the law for the reporting of events can lead to a creating of sufficient basis for safety indicators.

  4. Screening and evaluation of Second Half 1980 licensee event reports

    International Nuclear Information System (INIS)

    Waage, J.M.

    1981-09-01

    During the second part of 1980, two individual plant events occurred: Indian Point-2 (containment flooding) and Pilgrim-1 (uncontrolled blowdown). Significant event reports and update on generic problem areas and major equipment problem areas are included in this report

  5. Adverse event reporting in Czech long-term care facilities.

    Science.gov (United States)

    Hěib, Zdenřk; Vychytil, Pavel; Marx, David

    2013-04-01

    To describe adverse event reporting processes in long-term care facilities in the Czech Republic. Prospective cohort study involving a written questionnaire followed by in-person structured interviews with selected respondents. Long-term care facilities located in the Czech Republic. Staff of 111 long-term care facilities (87% of long-term care facilities in the Czech Republic). None. Sixty-three percent of long-term health-care facilities in the Czech Republic have adverse event-reporting processes already established, but these were frequently very immature programs sometimes consisting only of paper recording of incidents. Compared to questionnaire responses, in-person interview responses only partially tended to confirm the results of the written survey. Twenty-one facilities (33%) had at most 1 unconfirmed response, 31 facilities (49%) had 2 or 3 unconfirmed responses and the remaining 11 facilities (17%) had 4 or more unconfirmed responses. In-person interviews suggest that use of a written questionnaire to assess the adverse event-reporting process may have limited validity. Staff of the facilities we studied expressed an understanding of the importance of adverse event reporting and prevention, but interviews also suggested a lack of knowledge necessary for establishing a good institutional reporting system in long-term care.

  6. A software Event Summation System for MDSplus

    International Nuclear Information System (INIS)

    Davis, W.M.; Mastrovito, D.M.; Roney, P.G.; Sichta, P.

    2008-01-01

    The MDSplus data acquisition and management system uses software events for communication among interdependent processes anywhere on the network. Actions can then be triggered, such as a data-acquisition routine, or analysis or display programs waiting for data. A small amount of data, such as a shot number, can be passed with these events. Since programs sometimes need more than one data set, we developed a system on NSTX to declare composite events using logical AND and OR operations. The system is written in the IDL language, so it can be run on Linux, Macintosh or Windows platforms. Like MDSplus, the Experimental Physics and Industrial Control System (EPICS) is a core component of the NSTX software environment. The Event Summation System provides an IDL-based interface to EPICS. This permits EPICS-aware processes to be synchronized with MDSplus-aware processes, to provide, for example, engineering operators information about physics data acquisition and analysis. Reliability was a more important design consideration than performance for this system; the system's architecture includes features to support this. The system has run for weeks at a time without requiring manual intervention. Hundreds of incoming events per second can be handled reliably. All incoming and declared events are logged with a timestamp. The system can be configured easily through a single, easy-to-read text file

  7. A progress report of the switch-based data acquisition system prototype project and the application of switches from industry to high-energy physics event building

    International Nuclear Information System (INIS)

    Barsotti, E.; Booth, A.; Bowden, M.; Swoboda, C.

    1990-01-01

    A prototype of a data acquisition system based on a new scalable, highly-parallel, open-system architecture is being developed at Fermilab. The major component of the new architecture, the parallel event builder, is based on a telecommunications industry technique used in the implementation of switching systems, a barrel-shift switch. The architecture is scalable both in the expandability of the number of input channels and in the throughput of the system. Because of its scalability, the system is well suited for low to high-rate experiments, test beams and all SSC detectors. The architecture is open in that as new technologies are developed and made into commercial products (e.g., arrays of processors and workstations and standard data links), these new products can be easily integrated into the system with minimal system modifications and no modifications to the system's basic architecture. Scalability and openness should guarantee that the data acquisition system does not become obsolete during the lifetime of the experiment. The paper first gives a description of the architecture and the prototype project and then details both the prototype project's software and hardware status including details of some architecture simulation studies. Suggestions for future R and D work on the new data acquisition system architecture are then described. The paper concludes by examining interconnection networks from industry and their application to event building and to other areas of high-energy physics data acquisition systems

  8. Licensee Event Report sequence coding and search procedure workshop

    International Nuclear Information System (INIS)

    Cottrell, W.B.; Gallaher, R.B.

    1981-01-01

    Since mid-1980, the Office for Analysis and Evaluation of Operational Data (AEOD) of the Nuclear Regulatory Commission (NRC) has been developing procedures for the systematic review and analysis of Licensee Event Reports (LERs). These procedures generally address several areas of concern, including identification of significant trends and patterns, event sequence of occurrences, component failures, and system and plant effects. The AEOD and NSIC conducted a workshop on the new coding procedure at the American Museum of Science and Energy in Oak Ridge, TN, on November 24, 1980

  9. Screening and evaluation of First Half 1980 licensee event reports

    International Nuclear Information System (INIS)

    Waage, J.M.

    1981-05-01

    This program was established to identify those events which contain important operating experience and to communicate the insights gained from evaluation of such events to other plant owners and operators. This report represents a summary of that work for the LERs produced during roughly the first half of 1980. It discusses events of major significance reported during that period and summarizes those events which were identified as important. Several generic problem areas are discussed. Six major significant events took place during this period

  10. Analysis hierarchical model for discrete event systems

    Science.gov (United States)

    Ciortea, E. M.

    2015-11-01

    The This paper presents the hierarchical model based on discrete event network for robotic systems. Based on the hierarchical approach, Petri network is analysed as a network of the highest conceptual level and the lowest level of local control. For modelling and control of complex robotic systems using extended Petri nets. Such a system is structured, controlled and analysed in this paper by using Visual Object Net ++ package that is relatively simple and easy to use, and the results are shown as representations easy to interpret. The hierarchical structure of the robotic system is implemented on computers analysed using specialized programs. Implementation of hierarchical model discrete event systems, as a real-time operating system on a computer network connected via a serial bus is possible, where each computer is dedicated to local and Petri model of a subsystem global robotic system. Since Petri models are simplified to apply general computers, analysis, modelling, complex manufacturing systems control can be achieved using Petri nets. Discrete event systems is a pragmatic tool for modelling industrial systems. For system modelling using Petri nets because we have our system where discrete event. To highlight the auxiliary time Petri model using transport stream divided into hierarchical levels and sections are analysed successively. Proposed robotic system simulation using timed Petri, offers the opportunity to view the robotic time. Application of goods or robotic and transmission times obtained by measuring spot is obtained graphics showing the average time for transport activity, using the parameters sets of finished products. individually.

  11. ENGINEERED BARRIER SYSTEM FEATURES, EVENTS, AND PROCESSES

    Energy Technology Data Exchange (ETDEWEB)

    na

    2005-05-30

    This analysis report is one of the technical reports containing documentation of the Environmental Radiation Model for Yucca Mountain, Nevada (ERMYN), a biosphere model supporting the total system performance assessment (TSPA) for the license application (LA) for the Yucca Mountain repository. This analysis report describes the development of biosphere dose conversion factors (BDCFs) for the volcanic ash exposure scenario, and the development of dose factors for calculating inhalation dose during volcanic eruption. A graphical representation of the documentation hierarchy for the ERMYN is presented in Figure 1 - 1. This figure shows the interrelationships among the products (i.e., analysis and model reports) developed for biosphere modeling and provides an understanding of how this analysis report contributes to biosphere modeling. This report is one of two reports that develop biosphere BDCFs, which are input parameters for the TSPA model. The ''Biosphere Model Report'' (BSC 2004 [DIRS 169460]) describes in detail the ERMYN conceptual model and mathematical model. The input parameter reports, shown to the right of the Biosphere Model Report in Figure 1-1, contain detailed descriptions of the model input parameters, their development and the relationship between the parameters and specific features, events and processes (FEPs). This report describes biosphere model calculations and their output, the BDCFs, for the volcanic ash exposure scenario. This analysis receives direct input from the outputs of the ''Biosphere Model Report'' (BSC 2004 [DIRS 169460]) and from the five analyses that develop parameter values for the biosphere model (BSC 2005 [DIRS 172827]; BSC 2004 [DIRS 169672]; BSC 2004 [DIRS 169673]; BSC 2004 [DIRS 169458]; and BSC 2004 [DIRS 169459]). The results of this report are further analyzed in the ''Biosphere Dose Conversion Factor Importance and Sensitivity Analysis'' (Figure 1 - 1). The

  12. Adverse event reports following yellow fever vaccination, 2007-13.

    Science.gov (United States)

    Lindsey, Nicole P; Rabe, Ingrid B; Miller, Elaine R; Fischer, Marc; Staples, J Erin

    2016-05-01

    Yellow fever (YF) vaccines have been available since the 1930s and are generally considered safe and effective. However, rare reports of serious adverse events (SAE) following vaccination have prompted the Advisory Committee for Immunization Practices to periodically expand the list of conditions considered contraindications and precautions to vaccination. We describe adverse events following YF vaccination reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) from 2007 through 2013 and calculate age- and sex-specific reporting rates of all SAE, anaphylaxis, YF vaccine-associated neurologic disease (YEL-AND) and YF vaccine-associated viscerotropic disease (YEL-AVD). There were 938 adverse events following YF vaccination reported to VAERS from 2007 through 2013. Of these, 84 (9%) were classified as SAEs for a rate of 3.8 per 100 000 doses distributed. Reporting rates of SAEs increased with increasing age with a rate of 6.5 per 100 000 in persons aged 60-69 years and 10.3 for ≥70 years. The reporting rate for anaphylaxis was 1.3 per 100 000 doses distributed and was highest in persons ≤18 years (2.7 per 100 000). Reporting rates of YEL-AND and YEL-AVD were 0.8 and 0.3 per 100 000 doses distributed, respectively; both rates increased with increasing age. These findings reinforce the generally acceptable safety profile of YF vaccine, but highlight the importance of continued physician and traveller education regarding the risks and benefits of YF vaccination, particularly for older travellers. Published by Oxford University Press on behalf of the International Society of Travel Medicine, 2016. This work is written by US Government employees and is in the public domain in the United States.

  13. Trends and characteristics observed in nuclear events based on international nuclear event scale reports

    International Nuclear Information System (INIS)

    Watanabe, Norio

    2001-01-01

    The International Nuclear Event Scale (INES) is jointly operated by the IAEA and the OECD-NEA as a means designed for providing prompt, clear and consistent information related to nuclear events, that occurred at nuclear facilities, and facilitating communication between the nuclear community, the media and the public. Nuclear events are reported to the INES with the Scale', a consistent safety significance indicator, which runs from level 0, for events with no safety significance, to level 7 for a major accident with widespread health and environmental effects. Since the operation of INES was initiated in 1990, approximately 500 events have been reported and disseminated. The present paper discusses the trends observed in nuclear events, such as overall trends of the reported events and characteristics of safety significant events with level 2 or higher, based on the INES reports. (author)

  14. Discrete event systems diagnosis and diagnosability

    CERN Document Server

    Sayed-Mouchaweh, Moamar

    2014-01-01

    Discrete Event Systems: Diagnosis and Diagnosability addresses the problem of fault diagnosis of Discrete Event Systems (DES). This book provides the basic techniques and approaches necessary for the design of an efficient fault diagnosis system for a wide range of modern engineering applications. The different techniques and approaches are classified according to several criteria such as: modeling tools (Automata, Petri nets) that is used to construct the model; the information (qualitative based on events occurrences and/or states outputs, quantitative based on signal processing and data analysis) that is needed to analyze and achieve the diagnosis; the decision structure (centralized, decentralized) that is required to achieve the diagnosis. The goal of this classification is to select the efficient method to achieve the fault diagnosis according to the application constraints. This book focuses on the centralized and decentralized event based diagnosis approaches using formal language and automata as mode...

  15. Modeling and simulation of discrete event systems

    CERN Document Server

    Choi, Byoung Kyu

    2013-01-01

    Computer modeling and simulation (M&S) allows engineers to study and analyze complex systems. Discrete-event system (DES)-M&S is used in modern management, industrial engineering, computer science, and the military. As computer speeds and memory capacity increase, so DES-M&S tools become more powerful and more widely used in solving real-life problems. Based on over 20 years of evolution within a classroom environment, as well as on decades-long experience in developing simulation-based solutions for high-tech industries, Modeling and Simulation of Discrete-Event Systems is the only book on

  16. DEVS representation of dynamical systems - Event-based intelligent control. [Discrete Event System Specification

    Science.gov (United States)

    Zeigler, Bernard P.

    1989-01-01

    It is shown how systems can be advantageously represented as discrete-event models by using DEVS (discrete-event system specification), a set-theoretic formalism. Such DEVS models provide a basis for the design of event-based logic control. In this control paradigm, the controller expects to receive confirming sensor responses to its control commands within definite time windows determined by its DEVS model of the system under control. The event-based contral paradigm is applied in advanced robotic and intelligent automation, showing how classical process control can be readily interfaced with rule-based symbolic reasoning systems.

  17. Topical study on IRS events involving foreign material intrusion in plant systems. First issue. Report of a consultants meeting. Working material

    International Nuclear Information System (INIS)

    1997-01-01

    Recent exchange of operational safety experience among countries, within the framework of the IRS, revealed a noticeable increase in incidents involving foreign material intrusion (FMI) in nuclear power plant systems. These incidents appeared to have safety impact, sometimes widespread, on many systems and components, including the reactor core, control rods, the secondary side, and other support systems such as the electrical, air, and water systems. Notwithstanding the economic penalties and the operational problems that can arise from the FMI, many events indicated severe component damages, challenges to safety systems and to fuel integrity. Difficulties encountered with the removal of foreign material present further challenges due to the long term effects of such material remaining in the system and interacting with either fuel cladding, with the potential of releasing fission products in coolant systems, or with the system pressure boundary with the potential for material wear and sudden failure of the pressure boundary. The FMI topic was, therefore, one of a number of topics that was recommended by the TCM in 1996 for investigation. A consultant meeting was held at the IAEA during the period 14-18 April 1997 to address this topic. Figs

  18. Identifying and Synchronizing Health Information Technology (HIT) Events from FDA Medical Device Reports.

    Science.gov (United States)

    Kang, Hong; Wang, Frank; Zhou, Sicheng; Miao, Qi; Gong, Yang

    2017-01-01

    Health information technology (HIT) events, a subtype of patient safety events, pose a major threat and barrier toward a safer healthcare system. It is crucial to gain a better understanding of the nature of the errors and adverse events caused by current HIT systems. The scarcity of HIT event-exclusive databases and event reporting systems indicates the challenge of identifying the HIT events from existing resources. FDA Manufacturer and User Facility Device Experience (MAUDE) database is a potential resource for HIT events. However, the low proportion and the rapid evolvement of HIT-related events present challenges for distinguishing them from other equipment failures and hazards. We proposed a strategy to identify and synchronize HIT events from MAUDE by using a filter based on structured features and classifiers based on unstructured features. The strategy will help us develop and grow an HIT event-exclusive database, keeping pace with updates to MAUDE toward shared learning.

  19. Generalized Detectability for Discrete Event Systems

    Science.gov (United States)

    Shu, Shaolong; Lin, Feng

    2011-01-01

    In our previous work, we investigated detectability of discrete event systems, which is defined as the ability to determine the current and subsequent states of a system based on observation. For different applications, we defined four types of detectabilities: (weak) detectability, strong detectability, (weak) periodic detectability, and strong periodic detectability. In this paper, we extend our results in three aspects. (1) We extend detectability from deterministic systems to nondeterministic systems. Such a generalization is necessary because there are many systems that need to be modeled as nondeterministic discrete event systems. (2) We develop polynomial algorithms to check strong detectability. The previous algorithms are based on observer whose construction is of exponential complexity, while the new algorithms are based on a new automaton called detector. (3) We extend detectability to D-detectability. While detectability requires determining the exact state of a system, D-detectability relaxes this requirement by asking only to distinguish certain pairs of states. With these extensions, the theory on detectability of discrete event systems becomes more applicable in solving many practical problems. PMID:21691432

  20. Integrated system checkout report

    International Nuclear Information System (INIS)

    1991-01-01

    The planning and preparation phase of the Integrated Systems Checkout Program (ISCP) was conducted from October 1989 to July 1991. A copy of the ISCP, DOE-WIPP 90--002, is included in this report as an appendix. The final phase of the Checkout was conducted from July 10, 1991, to July 23, 1991. This phase exercised all the procedures and equipment required to receive, emplace, and retrieve contact handled transuranium (CH TRU) waste filled dry bins. In addition, abnormal events were introduced to simulate various equipment failures, loose surface radioactive contamination events, and personnel injury. This report provides a detailed summary of each days activities during this period. Qualification of personnel to safely conduct the tasks identified in the procedures and the abnormal events were verified by observers familiar with the Bin-Scale CH TRU Waste Test requirements. These observers were members of the staffs of Westinghouse WID Engineering, QA, Training, Health Physics, Safety, and SNL. Observers representing a number of DOE departments, the state of new Mexico, and the Defense Nuclear Facilities Safety Board observed those Checkout activities conducted during the period from July 17, 1991, to July 23, 1991. Observer comments described in this report are those obtained from the staff member observers. 1 figs., 1 tab

  1. Notifiable events in systems for fission of nuclear fuels - nuclear power plants and research reactors with maximum output exceeding 50 kW of thermal normal rating - in the Federal Republic of Germany. Quarterly report, 2nd quarter of 1996

    International Nuclear Information System (INIS)

    1996-01-01

    There were 32 notifiable events in nuclear power plants in Germany in the second quarter of 1996. The report lists and characterises all the 32 events notified in the reporting period. The events did not involve any radioactivity release exceeding the maximum permissible limits during this period, so that there were no radiation hazards to the population or the environment. One event was classified at level 1 of the INES event scale (Anomaly). Research reactor operators in Germany reported 5 notifiable events in the reporting period. The report lists and characterises these events. These events did not involve any radioactivity release exceeding the maximum permissible limits during this period, so that there were no radiation hazards to the population or the environment. All events notified were classified into the lowest categories of safety significance of the official event scales (N, or below scale). (orig./DG) [de

  2. Adverse event reporting in cancer clinical trial publications.

    Science.gov (United States)

    Sivendran, Shanthi; Latif, Asma; McBride, Russell B; Stensland, Kristian D; Wisnivesky, Juan; Haines, Lindsay; Oh, William K; Galsky, Matthew D

    2014-01-10

    Reporting adverse events is a critical element of a clinical trial publication. In 2003, the Consolidated Standards of Reporting Trials (CONSORT) group generated recommendations regarding the appropriate reporting of adverse events. The degree to which these recommendations are followed in oncology publications has not been comprehensively evaluated. A review of citations from PubMed, Medline, and Embase published between Jan 1, 2009 and December 31, 2011, identified eligible randomized, controlled phase III trials in metastatic solid malignancies. Publications were assessed for 14 adverse event-reporting elements derived from the CONSORT harms extension statement; a completeness score (range, 0 to 14) was calculated by adding the number of elements reported. Linear regression analysis identified which publication characteristics associated with reporting completeness. A total of 175 publications, with data for 96,125 patients, were included in the analysis. The median completeness score was eight (range, three to 12). Most publications (96%) reported only adverse events occurring above a threshold rate or severity, 37% did not specify the criteria used to select which adverse events were reported, and 88% grouped together adverse events of varying severity. Regression analysis revealed that trials without a stated funding source and with an earlier year of publication had significantly lower completeness scores. Reporting of adverse events in oncology publications of randomized trials is suboptimal and characterized by substantial selectivity and heterogeneity. The development of oncology-specific standards for adverse event reporting should be established to ensure consistency and provide critical information required for medical decision-making.

  3. Standardizing Medication Error Event Reporting in the U.S. Department of Defense

    National Research Council Canada - National Science Library

    Nosek, Ronald A., Jr; McMeekin, Judy; Rake, Geoffrey W

    2005-01-01

    ...) began an aggressive examination of medical errors and the strategies for minimizing them. A primary goal was the creation of a standardized medication event reporting system, including a central registry for the compilation of reported data...

  4. Learning from nuclear regulatory self-assessment. International peer review of the CSN report on lessons learnt from the essential service water system degradation event at the Vandellos nuclear power plant

    International Nuclear Information System (INIS)

    2006-01-01

    Nuclear regulatory self-assessment together with the benchmarking of regulatory practices against those of other countries operating nuclear power plants are key elements in maintaining a high level of nuclear safety. In that light, the Spanish Consejo de Seguridad Nuclear (CSN) formally asked the OECD Nuclear Energy Agency (NEA) to establish an international peer review team to assess the CSN report on the lessons learnt as a result of the 2004 Vandellos II event involving essential service water system degradation. The International Review Team considers the CSN report prepared in follow-up to the Vandellos event to be a commendable effort in regulatory self-assessment. The report, complemented by this international peer review, should enable the CSN to take appropriate action to ensure that its regulatory supervision is in line with best international practice. (authors)

  5. Case report of a near medical event in stereotactic radiotherapy due to improper units of measure from a treatment planning system

    International Nuclear Information System (INIS)

    Gladstone, D. J.; Li, S.; Jarvis, L. A.; Hartford, A. C.

    2011-01-01

    Purpose: The authors hereby notify the Radiation Oncology community of a potentially lethal error due to improper implementation of linear units of measure in a treatment planning system. The authors report an incident in which a patient was nearly mistreated during a stereotactic radiotherapy procedure due to inappropriate reporting of stereotactic coordinates by the radiation therapy treatment planning system in units of centimeter rather than in millimeter. The authors suggest a method to detect such errors during treatment planning so they are caught and corrected prior to the patient positioning for treatment on the treatment machine. Methods: Using pretreatment imaging, the authors found that stereotactic coordinates are reported with improper linear units by a treatment planning system. The authors have implemented a redundant, independent method of stereotactic coordinate calculation. Results: Implementation of a double check of stereotactic coordinates via redundant, independent calculation is simple and accurate. Use of this technique will avoid any future error in stereotactic treatment coordinates due to improper linear units, transcription, or other similar errors. Conclusions: The authors recommend an independent double check of stereotactic treatment coordinates during the treatment planning process in order to avoid potential mistreatment of patients.

  6. Case report of a near medical event in stereotactic radiotherapy due to improper units of measure from a treatment planning system

    Energy Technology Data Exchange (ETDEWEB)

    Gladstone, D. J.; Li, S.; Jarvis, L. A.; Hartford, A. C. [Division of Radiation Oncology, Department of Medicine, Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center, Lebanon, New Hampshire 03756 (United States); Division of Radiation Oncology, Department of Medicine, Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center, Lebanon, New Hampshire 03756 and Department of Radiation Oncology, Temple University Hospital, Philadelphia, Pennsylvania 19104 (United States); Division of Radiation Oncology, Department of Medicine, Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center, Lebanon, New Hampshire 03756 (United States)

    2011-07-15

    Purpose: The authors hereby notify the Radiation Oncology community of a potentially lethal error due to improper implementation of linear units of measure in a treatment planning system. The authors report an incident in which a patient was nearly mistreated during a stereotactic radiotherapy procedure due to inappropriate reporting of stereotactic coordinates by the radiation therapy treatment planning system in units of centimeter rather than in millimeter. The authors suggest a method to detect such errors during treatment planning so they are caught and corrected prior to the patient positioning for treatment on the treatment machine. Methods: Using pretreatment imaging, the authors found that stereotactic coordinates are reported with improper linear units by a treatment planning system. The authors have implemented a redundant, independent method of stereotactic coordinate calculation. Results: Implementation of a double check of stereotactic coordinates via redundant, independent calculation is simple and accurate. Use of this technique will avoid any future error in stereotactic treatment coordinates due to improper linear units, transcription, or other similar errors. Conclusions: The authors recommend an independent double check of stereotactic treatment coordinates during the treatment planning process in order to avoid potential mistreatment of patients.

  7. Abnormal Events for Reactor System and Facilities in HANARO

    Energy Technology Data Exchange (ETDEWEB)

    Choi, Ho Young; Lee, B. H.; Lee, M.; Kang, I. H.; Lee, U. G.; Sin, H. C.; Park, C. Y.; Song, B. S.; Lee, S. H.; Han, J. S

    2006-12-15

    This report gathers abnormal events related to reactor system and facilities of HANARO that happened during its operation over 10 years since the first criticality on February 1995. The collected examples will be utilized to the HANARO's operators as a useful guide.

  8. LAN attack detection using Discrete Event Systems.

    Science.gov (United States)

    Hubballi, Neminath; Biswas, Santosh; Roopa, S; Ratti, Ritesh; Nandi, Sukumar

    2011-01-01

    Address Resolution Protocol (ARP) is used for determining the link layer or Medium Access Control (MAC) address of a network host, given its Internet Layer (IP) or Network Layer address. ARP is a stateless protocol and any IP-MAC pairing sent by a host is accepted without verification. This weakness in the ARP may be exploited by malicious hosts in a Local Area Network (LAN) by spoofing IP-MAC pairs. Several schemes have been proposed in the literature to circumvent these attacks; however, these techniques either make IP-MAC pairing static, modify the existing ARP, patch operating systems of all the hosts etc. In this paper we propose a Discrete Event System (DES) approach for Intrusion Detection System (IDS) for LAN specific attacks which do not require any extra constraint like static IP-MAC, changing the ARP etc. A DES model is built for the LAN under both a normal and compromised (i.e., spoofed request/response) situation based on the sequences of ARP related packets. Sequences of ARP events in normal and spoofed scenarios are similar thereby rendering the same DES models for both the cases. To create different ARP events under normal and spoofed conditions the proposed technique uses active ARP probing. However, this probing adds extra ARP traffic in the LAN. Following that a DES detector is built to determine from observed ARP related events, whether the LAN is operating under a normal or compromised situation. The scheme also minimizes extra ARP traffic by probing the source IP-MAC pair of only those ARP packets which are yet to be determined as genuine/spoofed by the detector. Also, spoofed IP-MAC pairs determined by the detector are stored in tables to detect other LAN attacks triggered by spoofing namely, man-in-the-middle (MiTM), denial of service etc. The scheme is successfully validated in a test bed. Copyright © 2010 ISA. Published by Elsevier Ltd. All rights reserved.

  9. Event streaming in the online system

    CERN Document Server

    Klous, S; The ATLAS collaboration

    2010-01-01

    The Large Hadron Collider (LHC), currently in operation at CERN in Geneva, is a circular 27-kilometer-circumference machine, accelerating bunches of protons in opposite directions. The bunches will cross at four different interaction points with a bunch-crossing frequency of 40MHz. ATLAS, the largest LHC experiment, registers the signals induced by particles traversing the detector components on each bunch crossing. When this happens a total of around 1.5MB of data are collected. This results in a data rate of around 60 TB/s flowing out of the detector. Note that the available event storage space is limited to about 6 PB per year. With an operational period of about 20 million seconds per year, this requires a data reduction factor of 200:000 in the trigger and data acquisition (TDAQ) system. Events included in the recording rate budget are already subdivided and organized by ATLAS during data acquisition. So, the TDAQ system does not only take care of data reduction, but also organizes the collected events. ...

  10. Patients' identification and reporting of unsafe events at six hospitals in Japan.

    Science.gov (United States)

    Hasegawa, Tomonori; Fujita, Shigeru; Seto, Kanako; Kitazawa, Takefumi; Matsumoto, Kunichika

    2011-11-01

    Hospitals and other health care organizations have increasingly recognized the need to engage patients as participants in patient safety. A study was conducted to compare patients' and health care staff's identification and reporting of such events. A questionnaire was administered at six hospitals in Japan to outpatients and inpatients from November 2004 through February 2007. Patients were asked to respond to questions about experiences of possibly unsafe events. Patients experiencing such events were then asked about the events and whether they had reported their experience to health care staff. A specialist panel classified reported events as "uneasy-dissatisfying" or "unsafe." The response rates of outpatients and inpatients were 85.4% (1,506/1,764) and 54.3% (1,738/3,198), respectively. Among the respondents (> or = 20 years of age), 125 (8.7%) of the outpatients and 185 (10.9%) of the inpatients experienced uneasy-dissatisfying or unsafe events; 35 (2.4%) of the outpatients and 67 (4.0%) of the inpatients experienced unsafe events, the percent increasing with hospital stay. Only 38 (30.4%) of the outpatients and 62 (33.5%) of the inpatients reported the unsafe events to health care staff Only 17.1% of unsafe events reported by inpatients were identified by the in-house reporting systems of adverse events and near misses. For the uneasy-dissatisfying or unsafe events that patients did not think necessary to report, the patients often felt they were self-evident or easily identifiable by health care staff, had difficulty evaluating the event, did not expect their report to bring any improvement, or even felt that reporting it would create some disadvantage in their medical treatment. Patient reporting programs and in-house reporting systems, among other detection methods, should be regarded as complementary sources of information.

  11. Exploratory trend and pattern analysis of 1981 through 1983 Licensee Event Report data. Main report. Volume 1

    International Nuclear Information System (INIS)

    Hester, O.V.; Groh, M.R.; Farmer, F.G.

    1986-10-01

    This report presents an overview of the 1981 through 1983 Sequence Coding and Search System (SCSS) data base that contains nuclear power plant operational data derived from Licensee Event Reports (LERs) submitted to the United States Nuclear Regulatory Commission (USNRC). Both overall event reporting and events related to specific components, subsystems, systems, and personnel are discussed. At all of these levels of information, software is used to generate count data for contingency tables. Contingency table analysis is the main tool for the trend and pattern analysis. The tables focus primarily on faults associated with various components and other items of interest across different plants. The abstracts and other SCSS information on the LERs accounting for unusual counts in the tables were examined to gain insights from the events. Trends and patterns in LER reporting and reporting of events for various component groups were examined through log-linear modeling techniques

  12. General practitioners′ attitudes toward reporting and learning from adverse events: results from a survey

    DEFF Research Database (Denmark)

    Mikkelsen, Thorbjørn H.; Sokolowski, Ineta; Olesen, Frede

    2006-01-01

    , and circumstances under which such exchange is accepted. SUBJECTS: A structured questionnaire sent to 1198 GPs of whom 61% responded. RESULTS. GPs had a positive attitude towards discussing adverse events in the clinic with colleagues and staff and in their continuing medical education groups. The GPs had...... a positive attitude to reporting adverse events to a database if the system granted legal and administrative immunity to reporters. The majority preferred a reporting system located at a research institute. CONCLUSION: GPs have a very positive attitude towards discussing and reporting adverse events......OBJECTIVE: To investigate GPs' attitudes to and willingness to report and learn from adverse events and to study how a reporting system should function. DESIGN: Survey. SETTING: General practice in Denmark. MAIN OUTCOME MEASURES: GPs' attitudes to exchange of experience with colleagues and others...

  13. Proarrhythmic potential of dronedarone: emerging evidence from spontaneous adverse event reporting.

    Science.gov (United States)

    Kao, David P; Hiatt, William R; Krantz, Mori J

    2012-08-01

    To characterize the frequency and type of cardiac events, including torsade de pointes, associated with dronedarone and its structural analog, amiodarone, outside of the clinical trial setting. Retrospective analysis. Spontaneous reports in the United States Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) database generated between July 1, 2009, and June 30, 2011. All reports of adverse events during the study period were reviewed to identify cardiac events associated with any approved drug in the United States. The type and number of cardiac events associated with dronedarone and amiodarone were determined. Active ingredients were identified using the Drugs@FDA database, and the Medical Dictionary for Regulatory Activities (MedDRA) was used to aggregate related adverse events. To avoid redundant reporting, all statistics were generated in reference to unique case identifiers. Dronedarone was associated with more adverse cardiovascular event reports than amiodarone (810 vs 493 reports) during the study period. Dronedarone was also associated with the most reports of torsade de pointes of any approved drug in the United States (37 reports), followed by amiodarone (29 reports). Reports of ventricular arrhythmias and cardiac arrest (138 vs 113 reports) as well as heart failure (179 vs 126 reports) were more common with dronedarone than amiodarone. Dronedarone was associated with reports of ventricular arrhythmia, cardiac arrest, and torsade de pointes in clinical practice. Whether this observation accounts for the increased risk of fatal arrhythmia observed in a recent prospective trial requires further investigation. © 2012 Pharmacotherapy Publications, Inc. All rights reserved.

  14. Operational safety experience feedback by means of unusual event reports

    International Nuclear Information System (INIS)

    1996-07-01

    Operational experience of nuclear power plants can be used to great advantage to enhance safety performance provided adequate measures are in place to collect and analyse it and to ensure that the conclusions drawn are acted upon. Feedback of operating experience is thus an extremely important tool to ensure high standards of safety in operational nuclear power plants and to improve the capability to prevent serious accidents and to learn from minor deviations and equipment failures - which can serve as early warnings -to prevent even minor events from occurring. Mechanisms also need to be developed to ensure that operating experience is shared both nationally as well as internationally. The operating experience feedback process needs to be fully and effectively established within the nuclear power plant, the utility, the regulatory organization as well as in other institutions such as technical support organizations and designers. The main purpose of this publication is to reflect the international consensus as to the general principles and practices in the operational safety experience feedback process. The examples of national practices for the whole or for particular parts of the process are given in annexes. The publication complements the IAEA Safety Series No.93 ''Systems for Reporting Unusual Events in Nuclear Power Plants'' (1989) and may also give a general guidance for Member States in fulfilling their obligations stipulated in the Nuclear Safety Convention. Figs, tabs

  15. Operational safety experience feedback by means of unusual event reports

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-07-01

    Operational experience of nuclear power plants can be used to great advantage to enhance safety performance provided adequate measures are in place to collect and analyse it and to ensure that the conclusions drawn are acted upon. Feedback of operating experience is thus an extremely important tool to ensure high standards of safety in operational nuclear power plants and to improve the capability to prevent serious accidents and to learn from minor deviations and equipment failures - which can serve as early warnings -to prevent even minor events from occurring. Mechanisms also need to be developed to ensure that operating experience is shared both nationally as well as internationally. The operating experience feedback process needs to be fully and effectively established within the nuclear power plant, the utility, the regulatory organization as well as in other institutions such as technical support organizations and designers. The main purpose of this publication is to reflect the international consensus as to the general principles and practices in the operational safety experience feedback process. The examples of national practices for the whole or for particular parts of the process are given in annexes. The publication complements the IAEA Safety Series No.93 ``Systems for Reporting Unusual Events in Nuclear Power Plants`` (1989) and may also give a general guidance for Member States in fulfilling their obligations stipulated in the Nuclear Safety Convention. Figs, tabs.

  16. Final Project Report, DynAX Innovations in Programming Models, Compilers and Runtime Systems for Dynamic Adaptive Event Driven Execution Models

    Energy Technology Data Exchange (ETDEWEB)

    Gao, Guang [ET International, Inc., Newark, DE (United States); Meister, Benoit [Reservoir Labs, Inc. New York, NY (United States); Padua, David [Univ. of Illinois, Urbana-Champaign, IL (United States); Marquez, Andres [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2015-12-31

    This report contains a summary of the work done for the Dynax Project from 9/1/2012 to 8/31/2015. Much of the information presented is discussed in further detail in other STI annual and quarterly reports. Additionally, a NCE report was submitted covering work done from the period of 9/1/2015 to 12/31/2015.

  17. Patient safety event reporting in critical care: a study of three intensive care units.

    Science.gov (United States)

    Harris, Carolyn B; Krauss, Melissa J; Coopersmith, Craig M; Avidan, Michael; Nast, Patricia A; Kollef, Marin H; Dunagan, W Claiborne; Fraser, Victoria J

    2007-04-01

    To increase patient safety event reporting in three intensive care units (ICUs) using a new voluntary card-based event reporting system and to compare and evaluate observed differences in reporting among healthcare workers across ICUs. Prospective, single-center, interventional study. A medical ICU (19 beds), surgical ICU (24 beds), and cardiothoracic ICU (17 beds) at a 1,371-bed urban teaching hospital. Adult patients admitted to these three study ICUs. Use of a new, internally designed, card-based reporting program to solicit voluntary anonymous reporting of medical errors and patient safety concerns. During a 14-month period, 714 patient safety events were reported using a new card-based reporting system, reflecting a significant increase in reporting compared with pre-intervention Web-based reporting (20.4 reported events/1,000 patient days pre-intervention to 41.7 reported events/1,000 patient days postintervention; rate ratio, 2.05; 95% confidence interval, 1.79-2.34). Nurses submitted the majority of reports (nurses, 67.1%; physicians, 23.1%; other reporters, 9.5%); however, physicians experienced the greatest increase in reporting among their group (physicians, 43-fold; nurses, 1.7-fold; other reporters, 4.3-fold) relative to pre-intervention rates. There were significant differences in the reporting of harm by job description: 31.1% of reports from nurses, 36.2% from other staff, and 17.0% from physicians described events that did not reach/affect the patient (p = .001); and 33.9% of reports from physicians, 27.2% from nurses, and 13.0% from other staff described events that caused harm (p = .005). Overall reported patient safety events per 1,000 patient days differed by ICU (medical ICU = 55.5, cardiothoracic ICU = 25.3, surgical ICU = 40.2; p reporting system increased reporting significantly compared with pre-intervention Web-based reporting and revealed significant differences in reporting by healthcare worker and ICU. These differences may reveal

  18. A computer aided treatment event recognition system in radiation therapy

    International Nuclear Information System (INIS)

    Xia, Junyi; Mart, Christopher; Bayouth, John

    2014-01-01

    Purpose: To develop an automated system to safeguard radiation therapy treatments by analyzing electronic treatment records and reporting treatment events. Methods: CATERS (Computer Aided Treatment Event Recognition System) was developed to detect treatment events by retrieving and analyzing electronic treatment records. CATERS is designed to make the treatment monitoring process more efficient by automating the search of the electronic record for possible deviations from physician's intention, such as logical inconsistencies as well as aberrant treatment parameters (e.g., beam energy, dose, table position, prescription change, treatment overrides, etc). Over a 5 month period (July 2012–November 2012), physicists were assisted by the CATERS software in conducting normal weekly chart checks with the aims of (a) determining the relative frequency of particular events in the authors’ clinic and (b) incorporating these checks into the CATERS. During this study period, 491 patients were treated at the University of Iowa Hospitals and Clinics for a total of 7692 fractions. Results: All treatment records from the 5 month analysis period were evaluated using all the checks incorporated into CATERS after the training period. About 553 events were detected as being exceptions, although none of them had significant dosimetric impact on patient treatments. These events included every known event type that was discovered during the trial period. A frequency analysis of the events showed that the top three types of detected events were couch position override (3.2%), extra cone beam imaging (1.85%), and significant couch position deviation (1.31%). The significant couch deviation is defined as the number of treatments where couch vertical exceeded two times standard deviation of all couch verticals, or couch lateral/longitudinal exceeded three times standard deviation of all couch laterals and longitudinals. On average, the application takes about 1 s per patient when

  19. A computer aided treatment event recognition system in radiation therapy

    Energy Technology Data Exchange (ETDEWEB)

    Xia, Junyi, E-mail: junyi-xia@uiowa.edu; Mart, Christopher [Department of Radiation Oncology, University of Iowa Hospitals and Clinics, 200 Hawkins Drive, Iowa City, Iowa 52242 (United States); Bayouth, John [Department of Radiation Oncology, University of Iowa Hospitals and Clinics, 200 Hawkins Drive, Iowa City, Iowa 52242 and Department of Human Oncology, University of Wisconsin - Madison, 600 Highland Avenue, K4/B55, Madison, Wisconsin 53792-0600 (United States)

    2014-01-15

    Purpose: To develop an automated system to safeguard radiation therapy treatments by analyzing electronic treatment records and reporting treatment events. Methods: CATERS (Computer Aided Treatment Event Recognition System) was developed to detect treatment events by retrieving and analyzing electronic treatment records. CATERS is designed to make the treatment monitoring process more efficient by automating the search of the electronic record for possible deviations from physician's intention, such as logical inconsistencies as well as aberrant treatment parameters (e.g., beam energy, dose, table position, prescription change, treatment overrides, etc). Over a 5 month period (July 2012–November 2012), physicists were assisted by the CATERS software in conducting normal weekly chart checks with the aims of (a) determining the relative frequency of particular events in the authors’ clinic and (b) incorporating these checks into the CATERS. During this study period, 491 patients were treated at the University of Iowa Hospitals and Clinics for a total of 7692 fractions. Results: All treatment records from the 5 month analysis period were evaluated using all the checks incorporated into CATERS after the training period. About 553 events were detected as being exceptions, although none of them had significant dosimetric impact on patient treatments. These events included every known event type that was discovered during the trial period. A frequency analysis of the events showed that the top three types of detected events were couch position override (3.2%), extra cone beam imaging (1.85%), and significant couch position deviation (1.31%). The significant couch deviation is defined as the number of treatments where couch vertical exceeded two times standard deviation of all couch verticals, or couch lateral/longitudinal exceeded three times standard deviation of all couch laterals and longitudinals. On average, the application takes about 1 s per patient when

  20. The practice of reporting adverse events in a teaching hospital

    Directory of Open Access Journals (Sweden)

    Andréia Guerra Siman

    2017-10-01

    Full Text Available Abstract OBJECTIVE Understanding the practice of reporting adverse events by health professionals. METHOD A qualitative case study carried out in a teaching hospital with participants of the Patient Safety Center and the nursing team. The collection took place from May to December 2015, and was conducted through interviews, observation and documentary research to treat the data using Content Analysis. RESULTS 31 professionals participated in the study. Three categories were elaborated: The practice of reporting adverse events; Barriers in the effective practice of notifications; The importance of reporting adverse events. CONCLUSION Notification was permeated by gaps in knowledge, fear of punishment and informal communication, generating underreporting. It is necessary to improve the interaction between leaders and professionals, with an emphasis on communication and educational practice.

  1. Marketing reporting system

    OpenAIRE

    Hanić Hasan M.

    2004-01-01

    The main components of a developed and good organized marketing information system are: internal reporting system, marketing reporting system, market research system and analytical marketing system. Marketing reporting system provides data and information about changes in business and micro marketing environment. This component of MIS ensures that marketing managers are up-to-date with what is going on, and to be informed about changes in company marketing environment.

  2. Marketing reporting system

    Directory of Open Access Journals (Sweden)

    Hanić Hasan M.

    2004-01-01

    Full Text Available The main components of a developed and good organized marketing information system are: internal reporting system, marketing reporting system, market research system and analytical marketing system. Marketing reporting system provides data and information about changes in business and micro marketing environment. This component of MIS ensures that marketing managers are up-to-date with what is going on, and to be informed about changes in company marketing environment.

  3. On reporting results from randomized controlled trials with recurrent events

    Directory of Open Access Journals (Sweden)

    Sobolev Boris G

    2008-05-01

    Full Text Available Abstract Background Evidence-based medicine has been advanced by the use of standards for reporting the design and methodology of randomized controlled trials (RCT. Indeed, without this information it is difficult to assess the quality of evidence from an RCT. Although a variety of statistical methods are available for the analysis of recurrent events, reporting the effect of an intervention on outcomes that recur is an area that remains poorly understood in clinical research. The purpose of this paper is to outline guidelines for reporting results from RCTs where the outcome of interest is a recurrent event. Methods We used a simulation study to relate an event process and results from analyses of the gamma-Poisson, independent-increment, conditional, and marginal Cox models. We reviewed the utility of regression models for the rate of a recurrent event by articulating the associated study questions, preenting the risk sets, and interpreting the regression coefficients. Results Based on a single data set produced by simulation, we reported and contrasted results from statistical methods for evaluating treatment effect from an RCT with a recurrent outcome. We showed that each model has different study questions, assumptions, risk sets, and rate ratio interpretation, and so inferences should consider the appropriateness of the model for the RCT. Conclusion Our guidelines for reporting results from an RCT involving a recurrent event suggest that the study question and the objectives of the trial, such as assessing comparable groups and estimating effect size, should determine the statistical methods. The guidelines should allow clinical researchers to report appropriate measures from an RCT for understanding the effect of intervention on the occurrence of a recurrent event.

  4. Review of licensee event reports, 1976 to 1978

    International Nuclear Information System (INIS)

    1979-09-01

    This report was prepared in response to a request by the Chairman of the US Nuclear Regulatory Commission for the Advisory Committee on Reactor Safeguards to review, with specific objectives, the Licensee Event Reports (LERs) issued fom 1976 through 1978. A principal objective of the present study was to identify those events which have implications for improved reactor safety. Approximately 8,700 LERs were filed during the three-year period under review. These described events ranging from the trivial to those of major safety significance. This study has confirmed that LERs represent a source of valuable data and information. However, it must be recognized that a detailed review of LERs will not identify all safety problems likely to be encountered in the operation of nuclear power plants. As a result of this review, a number of classes of events were identified. These classes were subsequently categorized into three groups: (a) those having potentially serious safety implications, (b) events that must be regarded as matters of concern, and (c) events of lower safety significance but with excessive frequency

  5. Analysis of loss of offsite power events reported in nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Volkanovski, Andrija, E-mail: Andrija.VOLKANOVSKI@ec.europa.eu [European Commission, Joint Research Centre, Institute for Energy and Transport, P.O. Box 2, NL-1755 ZG Petten (Netherlands); Ballesteros Avila, Antonio; Peinador Veira, Miguel [European Commission, Joint Research Centre, Institute for Energy and Transport, P.O. Box 2, NL-1755 ZG Petten (Netherlands); Kančev, Duško [Kernkraftwerk Goesgen-Daeniken AG, CH-4658 Daeniken (Switzerland); Maqua, Michael [Gesellschaft für Anlagen-und-Reaktorsicherheit (GRS) gGmbH, Schwertnergasse 1, 50667 Köln (Germany); Stephan, Jean-Luc [Institut de Radioprotection et de Sûreté Nucléaire (IRSN), BP 17 – 92262 Fontenay-aux-Roses Cedex (France)

    2016-10-15

    Highlights: • Loss of offsite power events were identified in four databases. • Engineering analysis of relevant events was done. • The dominant root cause for LOOP are human failures. • Improved maintenance procedures can decrease the number of LOOP events. - Abstract: This paper presents the results of analysis of the loss of offsite power events (LOOP) in four databases of operational events. The screened databases include: the Gesellschaft für Anlagen und Reaktorsicherheit mbH (GRS) and Institut de Radioprotection et de Sûreté Nucléaire (IRSN) databases, the IAEA International Reporting System for Operating Experience (IRS) and the U.S. Licensee Event Reports (LER). In total 228 relevant loss of offsite power events were identified in the IRSN database, 190 in the GRS database, 120 in U.S. LER and 52 in IRS database. Identified events were classified in predefined categories. Obtained results show that the largest percentage of LOOP events is registered during On power operational mode and lasted for two minutes or more. The plant centered events is the main contributor to LOOP events identified in IRSN, GRS and IAEA IRS database. The switchyard centered events are the main contributor in events registered in the NRC LER database. The main type of failed equipment is switchyard failures in IRSN and IAEA IRS, main or secondary lines in NRC LER and busbar failures in GRS database. The dominant root cause for the LOOP events are human failures during test, inspection and maintenance followed by human failures due to the insufficient or wrong procedures. The largest number of LOOP events resulted in reactor trip followed by EDG start. The actions that can result in reduction of the number of LOOP events and minimize consequences on plant safety are identified and presented.

  6. Adverse Drug Event Monitoring at the Food and Drug Administration: Your Report Can Make a Difference

    OpenAIRE

    Ahmad, Syed Rizwanuddin

    2003-01-01

    The Food and Drug Administration (FDA) is responsible not only for approving drugs but also for monitoring their safety after they reach the market. The complete adverse event profile of a drug is not known at the time of approval because of the small sample size, short duration, and limited generalizability of pre-approval clinical trials. This report describes the FDA's postmarketing surveillance system, to which many clinicians submit reports of adverse drug events encountered while treati...

  7. Web-based online system for recording and examing of events in power plants

    International Nuclear Information System (INIS)

    Seyd Farshi, S.; Dehghani, M.

    2004-01-01

    Occurrence of events in power plants could results in serious drawbacks in generation of power. This suggests high degree of importance for online recording and examing of events. In this paper an online web-based system is introduced, which records and examines events in power plants. Throughout the paper, procedures for design and implementation of this system, its features and results gained are explained. this system provides predefined level of online access to all data of events for all its users in power plants, dispatching, regional utilities and top-level managers. By implementation of electric power industry intranet, an expandable modular system to be used in different sectors of industry is offered. Web-based online recording and examing system for events offers the following advantages: - Online recording of events in power plants. - Examing of events in regional utilities. - Access to event' data. - Preparing managerial reports

  8. FEATURES, EVENTS, AND PROCESSES: SYSTEM-LEVEL AND CRITICALITY

    International Nuclear Information System (INIS)

    D.L. McGregor

    2000-01-01

    The primary purpose of this Analysis/Model Report (AMR) is to identify and document the screening analyses for the features, events, and processes (FEPs) that do not easily fit into the existing Process Model Report (PMR) structure. These FEPs include the 3 1 FEPs designated as System-Level Primary FEPs and the 22 FEPs designated as Criticality Primary FEPs. A list of these FEPs is provided in Section 1.1. This AMR (AN-WIS-MD-000019) documents the Screening Decision and Regulatory Basis, Screening Argument, and Total System Performance Assessment (TSPA) Disposition for each of the subject Primary FEPs. This AMR provides screening information and decisions for the TSPA-SR report and provides the same information for incorporation into a project-specific FEPs database. This AMR may also assist reviewers during the licensing-review process

  9. FEATURES, EVENTS, AND PROCESSES: SYSTEM-LEVEL AND CRITICALITY

    Energy Technology Data Exchange (ETDEWEB)

    D.L. McGregor

    2000-12-20

    The primary purpose of this Analysis/Model Report (AMR) is to identify and document the screening analyses for the features, events, and processes (FEPs) that do not easily fit into the existing Process Model Report (PMR) structure. These FEPs include the 3 1 FEPs designated as System-Level Primary FEPs and the 22 FEPs designated as Criticality Primary FEPs. A list of these FEPs is provided in Section 1.1. This AMR (AN-WIS-MD-000019) documents the Screening Decision and Regulatory Basis, Screening Argument, and Total System Performance Assessment (TSPA) Disposition for each of the subject Primary FEPs. This AMR provides screening information and decisions for the TSPA-SR report and provides the same information for incorporation into a project-specific FEPs database. This AMR may also assist reviewers during the licensing-review process.

  10. Eyewitness Suggestibility and Source Similarity: Intrusions of Details from One Event into Memory Reports of Another Event

    Science.gov (United States)

    Lindsay, D. Stephen; Allen, Bem P.; Chan, Jason C. K.; Dahl, Leora C.

    2004-01-01

    We explored the effect of the degree of conceptual similarity between a witnessed event and an extra-event narrative on eyewitness suggestibility. Experiments 1A and 1B replicated Allen and Lindsay's (1998) finding that subjects sometimes intrude details from a narrative description of one event into their reports of a different visual event.…

  11. Assessing the Effectiveness of the Early Aberration Reporting System (EARS) for Early Event Detection of the H1N1 (Swine Flu) Virus

    Science.gov (United States)

    2010-09-01

    From Fricker & Hanni , 2010) ..............8 Figure 6. MCHD implementation of the EARS biosurveillance system (After Fricker & Hanni , 2010...11 Figure 8. Confirmed and probable H1N1 case rate by age group from April 15–July 24, 2009 (From Hanni ...United States by age group from April 15 to July 24, 2009 (From Hanni , 2009).......................13 Figure 10. CDC Testing Recommendations for

  12. Licensee Event Report (LER) compilation for month of March 1986. Volume 5, No. 3

    International Nuclear Information System (INIS)

    1986-04-01

    This monthly report contains Licensee Event Report (LER) operational information that was processed into the LER data file of the Nuclear Safety Information Center (NSIC) during the one month period identified on the cover of the document. The LERs, from which this information is derived, are submitted to the Nuclear Regulatory Commission (NRC) by nuclear power plant licensees in accordance with federal regulations. Procedures for LER reporting for revisions to those events occurring prior to 1984 are described in NRC Regulatory Guide 1.16 and NUREG-1061. The LER summaries in this report are arranged alphabetically by facility name and then chronologically by event date for each facility. Component, system, keyword, and component vendor indexes follow the summaries. Vendors are those identified by the utility when the LER form is initiated; the keywords for the component, system, and general keyword indexes are assigned by the computer using correlation tables from the Sequence Coding and Search System

  13. Serious adverse events reported for anti-obesity medicines

    DEFF Research Database (Denmark)

    Aagaard, L; Hallgreen, C E; Hansen, Ebba Holme

    2016-01-01

    BACKGROUND: Use of anti-obesity medicines has been linked with serious cardiac and psychiatric adverse events (AEs). Spontaneous reports can provide information about serious, rare and unknown AEs occurring after time of marketing. In Europe, information about AEs reported for anti-obesity medici...... are being marketed, the utilisation of anti-obesity medicines is widespread, and therefore systematic monitoring of the safety of these medicines is necessary.International Journal of Obesity accepted article preview online, 01 August 2016. doi:10.1038/ijo.2016.135.......BACKGROUND: Use of anti-obesity medicines has been linked with serious cardiac and psychiatric adverse events (AEs). Spontaneous reports can provide information about serious, rare and unknown AEs occurring after time of marketing. In Europe, information about AEs reported for anti......-obesity medicines can be accessed in the EudraVigilance database (EV). Therefore, we aimed to identify and characterise adverse events (AEs) associated with use of anti-obesity medicines in Europe. METHODS: AE reports submitted for anti-obesity medicines (Anatomical Therapeutic Chemical [ATC] group A08A) from 2007...

  14. The logic of surveillance guidelines: an analysis of vaccine adverse event reports from an ontological perspective.

    Directory of Open Access Journals (Sweden)

    Mélanie Courtot

    Full Text Available BACKGROUND: When increased rates of adverse events following immunization are detected, regulatory action can be taken by public health agencies. However to be interpreted reports of adverse events must be encoded in a consistent way. Regulatory agencies rely on guidelines to help determine the diagnosis of the adverse events. Manual application of these guidelines is expensive, time consuming, and open to logical errors. Representing these guidelines in a format amenable to automated processing can make this process more efficient. METHODS AND FINDINGS: Using the Brighton anaphylaxis case definition, we show that existing clinical guidelines used as standards in pharmacovigilance can be logically encoded using a formal representation such as the Adverse Event Reporting Ontology we developed. We validated the classification of vaccine adverse event reports using the ontology against existing rule-based systems and a manually curated subset of the Vaccine Adverse Event Reporting System. However, we encountered a number of critical issues in the formulation and application of the clinical guidelines. We report these issues and the steps being taken to address them in current surveillance systems, and in the terminological standards in use. CONCLUSIONS: By standardizing and improving the reporting process, we were able to automate diagnosis confirmation. By allowing medical experts to prioritize reports such a system can accelerate the identification of adverse reactions to vaccines and the response of regulatory agencies. This approach of combining ontology and semantic technologies can be used to improve other areas of vaccine adverse event reports analysis and should inform both the design of clinical guidelines and how they are used in the future. AVAILABILITY: Sufficient material to reproduce our results is available, including documentation, ontology, code and datasets, at http://purl.obolibrary.org/obo/aero.

  15. Self-reported non-severe hypoglycaemic events in Europe

    DEFF Research Database (Denmark)

    Östenson, C G; Geelhoed-Duijvestijn, P; Lahtela, J

    2014-01-01

    AIMS: Hypoglycaemia presents a barrier to optimum diabetes management but data are limited on the frequency of hypoglycaemia incidents outside of clinical trials. The present study investigated the rates of self-reported non-severe hypoglycaemic events, hypoglycaemia awareness and physician...... discussion of events in people with Type 1 diabetes mellitus or insulin-treated Type 2 diabetes mellitus. METHODS: People in seven European countries aged >15 years with Type 1 diabetes or insulin-treated Type 2 diabetes (basal-only, basal-bolus and other insulin regimens) were recruited via consumer panels......, nurses, telephone recruitment and family referrals. Respondents completed four online questionnaires. The first questionnaire collected background information on demographics and hypoglycaemia-related behaviour, whilst all four questionnaires collected data on non-severe hypoglycaemic events...

  16. National Outbreak Reporting System

    Data.gov (United States)

    U.S. Department of Health & Human Services — The National Outbreak Reporting System (NORS) is a web-based platform designed to support reporting to CDC by local, state, and territorial health departments in the...

  17. Incidence and pattern of 12 years of reported transfusion adverse events in Zimbabwe: A retrospective analysis

    NARCIS (Netherlands)

    Mafirakureva, Nyashadzaishe; Khoza, Star; Mvere, David A.; Chitiyo, McLeod E.; Postma, Maarten J.; Van Hulst, Marinus

    2014-01-01

    Background. Haemovigilance hinges on a systematically structured reporting system, which unfortunately does not always exist in resource-limited settings. We determined the incidence and pattern of transfusion-related adverse events reported to the National Blood Service Zimbabwe. Materials and

  18. A Key Event Path Analysis Approach for Integrated Systems

    Directory of Open Access Journals (Sweden)

    Jingjing Liao

    2012-01-01

    Full Text Available By studying the key event paths of probabilistic event structure graphs (PESGs, a key event path analysis approach for integrated system models is proposed. According to translation rules concluded from integrated system architecture descriptions, the corresponding PESGs are constructed from the colored Petri Net (CPN models. Then the definitions of cycle event paths, sequence event paths, and key event paths are given. Whereafter based on the statistic results after the simulation of CPN models, key event paths are found out by the sensitive analysis approach. This approach focuses on the logic structures of CPN models, which is reliable and could be the basis of structured analysis for discrete event systems. An example of radar model is given to characterize the application of this approach, and the results are worthy of trust.

  19. Event storm detection and identification in communication systems

    International Nuclear Information System (INIS)

    Albaghdadi, Mouayad; Briley, Bruce; Evens, Martha

    2006-01-01

    Event storms are the manifestation of an important class of abnormal behaviors in communication systems. They occur when a large number of nodes throughout the system generate a set of events within a small period of time. It is essential for network management systems to detect every event storm and identify its cause, in order to prevent and repair potential system faults. This paper presents a set of techniques for the effective detection and identification of event storms in communication systems. First, we introduce a new algorithm to synchronize events to a single node in the system. Second, the system's event log is modeled as a normally distributed random process. This is achieved by using data analysis techniques to explore and then model the statistical behavior of the event log. Third, event storm detection is proposed using a simple test statistic combined with an exponential smoothing technique to overcome the non-stationary behavior of event logs. Fourth, the system is divided into non-overlapping regions to locate the main contributing regions of a storm. We show that this technique provides us with a method for event storm identification. Finally, experimental results from a commercially deployed multimedia communication system that uses these techniques demonstrate their effectiveness

  20. Integrated Reporting Information System -

    Data.gov (United States)

    Department of Transportation — The Integrated Reporting Information System (IRIS) is a flexible and scalable web-based system that supports post operational analysis and evaluation of the National...

  1. Why Clinicians Don't Report Adverse Drug Events: Qualitative Study.

    Science.gov (United States)

    Hohl, Corinne M; Small, Serena S; Peddie, David; Badke, Katherin; Bailey, Chantelle; Balka, Ellen

    2018-02-27

    Adverse drug events are unintended and harmful events related to medications. Adverse drug events are important for patient care, quality improvement, drug safety research, and postmarketing surveillance, but they are vastly underreported. Our objectives were to identify barriers to adverse drug event documentation and factors contributing to underreporting. This qualitative study was conducted in 1 ambulatory center, and the emergency departments and inpatient wards of 3 acute care hospitals in British Columbia between March 2014 and December 2016. We completed workplace observations and focus groups with general practitioners, hospitalists, emergency physicians, and hospital and community pharmacists. We analyzed field notes by coding and iteratively analyzing our data to identify emerging concepts, generate thematic and event summaries, and create workflow diagrams. Clinicians validated emerging concepts by applying them to cases from their clinical practice. We completed 238 hours of observations during which clinicians investigated 65 suspect adverse drug events. The observed events were often complex and diagnosed over time, requiring the input of multiple providers. Providers documented adverse drug events in charts to support continuity of care but never reported them to external agencies. Providers faced time constraints, and reporting would have required duplication of documentation. Existing reporting systems are not suited to capture the complex nature of adverse drug events or adapted to workflow and are simply not used by frontline clinicians. Systems that are integrated into electronic medical records, make use of existing data to avoid duplication of documentation, and generate alerts to improve safety may address the shortcomings of existing systems and generate robust adverse drug event data as a by-product of safer care. ©Corinne M Hohl, Serena S Small, David Peddie, Katherin Badke, Chantelle Bailey, Ellen Balka. Originally published in JMIR

  2. Transition-Systems, Event Structures, and Unfoldings

    DEFF Research Database (Denmark)

    Nielsen, Mogens; Rozenberg, Grzegorz; Thiagarajan, P.S.

    1995-01-01

    systems. Here we show that by smoothly strengthening the regional axioms for elementary transition systems, one obtains a subclass called occurrence transition system. We then prove that occurrence transition systems are the transition system model of yet another basic model of concurrency, namely, prime......A subclass of transition systems called elementary transition systems can be identified with the help of axioms based on a structural notion called regions. Elementary transition systems have been shown to be the transition system model of a basic system model of net theory called elementary net...

  3. A novel technique to extract events from access control system and locate persons

    International Nuclear Information System (INIS)

    Vincent, M.; Vaidyanathan, Mythili; Patidar, Suresh Chandra; Prabhakara Rao, G.

    2011-01-01

    Indira Gandhi Centre for Atomic Research houses many laboratories which handle radioactive materials and classified materials. Protection and accounting of men and material and critical facilities are important aspect of nuclear security. Access Control System (ACS) is used to enhance the protective measures against elevated threat environment. Access control system hardware consists of hand geometry readers, RFID readers, Controllers, Electromagnetic door locks, Turnstiles, fiber cable laying and termination etc. Access Control System controls and monitors the people accessing the secured facilities. Access Control System generates events on: 1. Showing of RFID card, 2. Rotation of turnstile, 3. Download of valid card numbers, 4. Generation of alarms etc. Access control system turnstiles are located in main entrance of a facility, entrance of inside laboratory and door locks are fixed on secured facilities. Events are stored in SQL server database. From the events stored in database a novel technique is developed to extract events and list the persons in a particular facility, list all entry/exit events on one day, list the first in and last out entries. This paper discusses the complex multi level group by queries and software developed to extract events from database, locate persons and generate reports. Software is developed as a web application in ASP.Net and query is written in SQL. User can select the doors, type of events and generate reports. Reports are generated using the master data stored about employees RFID cards and events data stored in tables. Four types of reports are generated 1. Plant Emergency Report, 2. Locate User Report, 3. Entry - Exit Report, 4. First in Last out Report. To generate plant emergency report for whole plant only events generated in outer gates have to be considered. To generate plant emergency report for inside laboratory, events generated in entrance gates have to be ignored. (author)

  4. Human error probability estimation using licensee event reports

    International Nuclear Information System (INIS)

    Voska, K.J.; O'Brien, J.N.

    1984-07-01

    Objective of this report is to present a method for using field data from nuclear power plants to estimate human error probabilities (HEPs). These HEPs are then used in probabilistic risk activities. This method of estimating HEPs is one of four being pursued in NRC-sponsored research. The other three are structured expert judgment, analysis of training simulator data, and performance modeling. The type of field data analyzed in this report is from Licensee Event reports (LERs) which are analyzed using a method specifically developed for that purpose. However, any type of field data or human errors could be analyzed using this method with minor adjustments. This report assesses the practicality, acceptability, and usefulness of estimating HEPs from LERs and comprehensively presents the method for use

  5. Detection and location of multiple events by MARS. Final report

    International Nuclear Information System (INIS)

    Wang, J.; Masso, J.F.; Archambeau, C.B.; Savino, J.M.

    1980-09-01

    Seismic data from two explosions was processed using the Systems Science and Software MARS (Multiple Arrival Recognition System) seismic event detector in an effort to determine their relative spatial and temporal separation on the basis of seismic data alone. The explosions were less than 1.0 kilometer apart and were separated by less than 0.5 sec in origin times. The seismic data consisted of nine local accelerograms (r < 1.0 km) and four regional (240 through 400 km) seismograms. The MARS processing clearly indicates the presence of multiple explosions, but the restricted frequency range of the data inhibits accurate time picks and hence limits the precision of the event location

  6. Event-Based Modularization of Reactive Systems

    NARCIS (Netherlands)

    Malakuti Khah Olun Abadi, Somayeh; Aksit, Mehmet

    2014-01-01

    There is a large number of complex software systems that have reactive behavior. As for any other software system, reactive systems are subject to evolution demands. This paper defines a set requirements that must be fulfilled so that reuse of reactive software systems can be increased. Detailed

  7. Under-reporting of Adverse Events in the Biomedical Literature

    Directory of Open Access Journals (Sweden)

    Ronald N. Kostoff

    2016-11-01

    Full Text Available Purpose: To address the under-reporting of research results, with emphasis on the underreporting/distorted reporting of adverse events in the biomedical research literature. Design/methodology/approach: A four-step approach is used:(1 To identify the characteristics of literature that make it adequate to support policy; (2 to show how each of these characteristics becomes degraded to make inadequate literature; (3 to identify incentives to prevent inadequate literature; and (4 to show policy implications of inadequate literature. Findings: This review has provided reasons for, and examples of, adverse health effects of myriad substances (1 being under-reported in the premiere biomedical literature, or (2 entering this literature in distorted form. Since there is no way to gauge the extent of this under/distorted-reporting, the quality and credibility of the ‘premiere’ biomedical literature is unknown. Therefore, any types of meta-analyses or scientometric analyses of this literature will have unknown quality and credibility. The most sophisticated scientometric analysis cannot compensate for a highly flawed database. Research limitations: The main limitation is in identifying examples of under-reporting. There are many incentives for under-reporting and few dis-incentives. Practical implications: Almost all research publications, addressing causes of disease, treatments for disease, diagnoses for disease, scientometrics of disease and health issues, and other aspects of healthcare, build upon previous healthcare-related research published. Many researchers will not have laboratories or other capabilities to replicate or validate the published research, and depend almost completely on the integrity of this literature. If the literature is distorted, then future research can be misguided, and health policy recommendations can be ineffective or worse. Originality/value: This review has examined a much wider range of technical and nontechnical

  8. Synchronous Parallel System for Emulation and Discrete Event Simulation

    Science.gov (United States)

    Steinman, Jeffrey S. (Inventor)

    2001-01-01

    A synchronous parallel system for emulation and discrete event simulation having parallel nodes responds to received messages at each node by generating event objects having individual time stamps, stores only the changes to the state variables of the simulation object attributable to the event object and produces corresponding messages. The system refrains from transmitting the messages and changing the state variables while it determines whether the changes are superseded, and then stores the unchanged state variables in the event object for later restoral to the simulation object if called for. This determination preferably includes sensing the time stamp of each new event object and determining which new event object has the earliest time stamp as the local event horizon, determining the earliest local event horizon of the nodes as the global event horizon, and ignoring events whose time stamps are less than the global event horizon. Host processing between the system and external terminals enables such a terminal to query, monitor, command or participate with a simulation object during the simulation process.

  9. Logical Discrete Event Systems in a trace theory based setting

    NARCIS (Netherlands)

    Smedinga, R.

    1993-01-01

    Discrete event systems can be modelled using a triple consisting of some alphabet (representing the events that might occur), and two trace sets (sets of possible strings) denoting the possible behaviour and the completed tasks of the system. Using this definition we are able to formulate and solve

  10. Mixed Methods Analysis of Medical Error Event Reports: A Report from the ASIPS Collaborative

    National Research Council Canada - National Science Library

    Harris, Daniel M; Westfall, John M; Fernald, Douglas H; Duclos, Christine W; West, David R; Niebauer, Linda; Marr, Linda; Quintela, Javan; Main, Deborah S

    2005-01-01

    .... This paper presents a mixed methods approach to analyzing narrative error event reports. Mixed methods studies integrate one or more qualitative and quantitative techniques for data collection and analysis...

  11. Client and event driven data hub system at CDF

    International Nuclear Information System (INIS)

    Kilminster, Ben; McFarland, Kevin; Vaiciulis, Tony; Matsunaga, Hiroyuki; Shimojima, Makoto

    2001-01-01

    The Consumer-Server Logger (CSL) system at the Collider Detector at Fermilab is a client and event driven data hub capable of receiving physics events from multiple connections, and logging them to multiple streams while distributing them to multiple online analysis programs (consumers). Its multiple-partitioned design allows data flowing through different paths of the detector sub-systems to be processed separately. The CSL system, using a set of internal memory buffers and message queues mapped to the location of events within its programs, and running on an SGI 2200 Server, is able to process at least the required 20 MB/s of constant event logging (75 Hz of 250 KB events) while also filtering up to 10 MB/s to consumers requesting specific types of events

  12. Nonstochastic Analysis of Manufacturing Systems Using Timed-Event Graphs

    DEFF Research Database (Denmark)

    Hulgaard, Henrik; Amon, Tod

    1996-01-01

    Using automated methods to analyze the temporal behavior ofmanufacturing systems has proven to be essential and quite beneficial.Popular methodologies include Queueing networks, Markov chains,simulation techniques, and discrete event systems (such as Petrinets). These methodologies are primarily...

  13. News and Events - Nanodelivery Systems and Devices Branch

    Science.gov (United States)

    The latest news from the Nanodelivery Systems and Devices Branch and the Alliance, as well as upcoming and past events attended by the Nanodelivery Systems and Devices Branchstaff, and relevant upcoming scientific meetings.

  14. A Risk Assessment System with Automatic Extraction of Event Types

    Science.gov (United States)

    Capet, Philippe; Delavallade, Thomas; Nakamura, Takuya; Sandor, Agnes; Tarsitano, Cedric; Voyatzi, Stavroula

    In this article we describe the joint effort of experts in linguistics, information extraction and risk assessment to integrate EventSpotter, an automatic event extraction engine, into ADAC, an automated early warning system. By detecting as early as possible weak signals of emerging risks ADAC provides a dynamic synthetic picture of situations involving risk. The ADAC system calculates risk on the basis of fuzzy logic rules operated on a template graph whose leaves are event types. EventSpotter is based on a general purpose natural language dependency parser, XIP, enhanced with domain-specific lexical resources (Lexicon-Grammar). Its role is to automatically feed the leaves with input data.

  15. An expert system for prevention of abnormal event recurrence

    International Nuclear Information System (INIS)

    Nishiyama, Takuya

    1990-01-01

    A huge amount of information related to abnormal events occurring in nuclear power plants in Japan and abroad is collected and accumulated in the Nuclear Information Center at CRIEPI. This information contains a variety of knowledge which may be useful for prevention of similar trouble. An expert system named, 'Consultation System for Prevention of Abnormal-Event Recurrence (CSPAR) is being developed with the objective of preventing recurrence of similar abnormal events by offering an effective means of utilizing such knowledge. This paper presents the key points in designing and constructing the system, the system functional outline, and some demonstration examples. (author)

  16. Licensee Event Report (LER) compilation for month of February 1984. Vol. 3, No. 2

    Energy Technology Data Exchange (ETDEWEB)

    1984-03-01

    This monthly report contains LER operational information that was processed into the LER data file of the Nuclear Safety Information Center (NSIC) during this period. The LER summaries are arranged alphabetically by facility name and then chronologically by event date for each facility. Component, system, keyword, and component vendor indexes follow the summaries.

  17. Mutual Events in the Uranian satellite system in 2007

    Science.gov (United States)

    Arlot, J. E.

    2008-09-01

    observed "pole-on" and the relative inclinations of the orbits of the satellites are very difficult to know. More, this knowledge should allow us to determine the precession of Uranus which is not yet known. Another reason to improve the dynamics of the Uranian satellites is to quantify the dissipation of energy inside the satellites because of the tides: only very accurate astrometric observations may allow to reach such a result. We used two models for our purpose: the one from Laskar and Jacobson (GUST86) based upon observations made using observations made from 1911 to 1986 [1] and the one from Arlot, Lainey and Thuillot (LA06) [2] based upon a different sets of observations made from 1950 to 2006. Astrometric observations Since the mutual events are observable only every 42 years (in fact, 2007 was the first time where mutual events were observed on the Uranian system), many other astrometric observations were performed, mainly with photographic plates, CCD targets or using a meridian transit circle. These observations and their accuracy will be compared with mutual events. Note that these observations introduce some biases in the data (date of the opposition, absolute position of the planet), different than those of mutual events (equinox time). Observations of mutual events in 2007 Due to the difficulty of the observations, very few observations were made: about 15 events were observed using telescopes with apertures from 40 cm to 8 meters... The observing sites which reported observations were Marseille and Pic du Midi (France), Canarian Islands (Spain), La Silla and Paranal (Chile), Itajuba (Brazil), Tubitak (Turkey), Hanle (India) and Siding Spring (Australia). A preliminary analysis Some light curves were reduced and a comparison has been made with the theoretical calculations of the events. A preliminary analysis shows that LA06 has smaller residuals in the longitudes of the satellites than GUST86 but the residuals are equivalent in latitude. This confirms the

  18. Performance and system flexibility of the CDF Hardware Event Builder

    Energy Technology Data Exchange (ETDEWEB)

    Shaw, T.M.; Schurecht, K. (Fermi National Accelerator Lab., Batavia, IL (United States)); Sinervo, P. (Toronto Univ., ON (Canada). Dept. of Physics)

    1991-11-01

    The CDF Hardware Event Builder (1) is a flexible system which is built from a combination of three different 68020-based single width Fastbus modules. The system may contain as few as three boards or as many as fifteen, depending on the specific application. Functionally, the boards receive a command to read out the raw event data from a set of Fastbus based data buffers ( scanners''), reformat data and then write the data to a Level 3 trigger/processing farm which will decide to throw the event away or to write it to tape. The data acquisition system at CDF will utilize two nine board systems which will allow an event rate of up to 35 Hz into the Level 3 trigger. This paper will present detailed performance factors, system and individual board architecture, and possible system configurations.

  19. To what extent are adverse events found in patient records reported by patients and healthcare professionals via complaints, claims and incident reports?

    Directory of Open Access Journals (Sweden)

    van der Wal Gerrit

    2011-02-01

    Full Text Available Abstract Background Patient record review is believed to be the most useful method for estimating the rate of adverse events among hospitalised patients. However, the method has some practical and financial disadvantages. Some of these disadvantages might be overcome by using existing reporting systems in which patient safety issues are already reported, such as incidents reported by healthcare professionals and complaints and medico-legal claims filled by patients or their relatives. The aim of the study is to examine to what extent the hospital reporting systems cover the adverse events identified by patient record review. Methods We conducted a retrospective study using a database from a record review study of 5375 patient records in 14 hospitals in the Netherlands. Trained nurses and physicians using a method based on the protocol of The Harvard Medical Practice Study previously reviewed the records. Four reporting systems were linked with the database of reviewed records: 1 informal and 2 formal complaints by patients/relatives, 3 medico-legal claims by patients/relatives and 4 incident reports by healthcare professionals. For each adverse event identified in patient records the equivalent was sought in these reporting systems by comparing dates and descriptions of the events. The study focussed on the number of adverse event matches, overlap of adverse events detected by different sources, preventability and severity of consequences of reported and non-reported events and sensitivity and specificity of reports. Results In the sample of 5375 patient records, 498 adverse events were identified. Only 18 of the 498 (3.6% adverse events identified by record review were found in one or more of the four reporting systems. There was some overlap: one adverse event had an equivalent in both a complaint and incident report and in three cases a patient/relative used two or three systems to complain about an adverse event. Healthcare professionals

  20. Technology-Induced Errors and Adverse Event Reporting in an Organizational Learning Perspective.

    Science.gov (United States)

    Vinther, Line Dausel; Jensen, Christian Møller; Hjelmager, Ditte Meulengracht; Lyhne, Nicoline; Nøhr, Christian

    2017-01-01

    This paper addresses the possibilities of evaluating technology-induced errors, through the utilization of experiences of the Danish adverse event reporting system. The learning loop in the adverse event reporting system is identified and analyzed, to examine which elements can be utilized to evaluate technologies. The empirical data was collected through interviews and a workshop with members of the nursing staff at a nursing home in Aalborg, Denmark. It was found that, the establishment of sustainable feedback learning loops depends on shared visions in the organization and how creating shared visions requires involvement and participation. Secondly, care workers must possess fundamental knowledge about the technologies available to them. Thirdly comprehensive classification of adverse events should be established to allow for a systematic and goal directed feed-back process.

  1. In situ simulation: Taking reported critical incidents and adverse events back to the clinic

    DEFF Research Database (Denmark)

    Juul, Jonas; Paltved, Charlotte; Krogh, Kristian

    2014-01-01

    for content analysis4 and thematic analysis5. Medical experts and simulation faculty will design scenarios for in situ simulation training based on the analysis. Short-term observations using time logs will be performed along with interviews with key informants at the departments. Video data will be collected...... improve patient safety if coupled with training and organisational support2. Insight into the nature of reported critical incidents and adverse events can be used in writing in situ simulation scenarios and thus lead to interventions that enhance patient safety. The patient safety literature emphasises...... well-developed non-technical skills in preventing medical errors3. Furthermore, critical incidents and adverse events reporting systems comprise a knowledgebase to gain in-depth insights into patient safety issues. This study explores the use of critical incidents and adverse events reports to inform...

  2. Corporate Disclosure, Materiality, and Integrated Report: An Event Study Analysis

    Directory of Open Access Journals (Sweden)

    Maria Cleofe Giorgino

    2017-11-01

    Full Text Available Within the extensive literature investigating the impacts of corporate disclosure in supporting the sustainable growth of an organization, few studies have included in the analysis the materiality issue referred to the information being disclosed. This article aims to address this gap, exploring the effect produced on capital markets by the publication of a recent corporate reporting tool, Integrated Report (IR. The features of this tool are that it aims to represent the multidimensional impact of the organization’s activity and assumes materiality as a guiding principle of the report drafting. Adopting the event study methodology associated with a statistical significance test for categorical data, our results verify that an organization’s release of IR is able to produce a statistically significant impact on the related share prices. Moreover, the term “integrated” assigned to the reports plays a significant role in the impact on capital markets. Our findings have beneficial implications for both researchers and practitioners, adding new evidence for the IR usefulness as a corporate disclosure tool and the effect of an organization’s decision to disclose material information.

  3. Sources Of Incidental Events In Collective Water Supply System

    Directory of Open Access Journals (Sweden)

    Szpak Dawid

    2015-11-01

    Full Text Available The publication presents the main types of incidental events in collective water supply system. The special attention was addressed to the incidental events associated with a decrease in water quality, posing a threat to the health and life of inhabitants. The security method against incidental contamination in the water source was described.

  4. The evaluation of a web-based incident reporting system.

    Science.gov (United States)

    Kuo, Ya-Hui; Lee, Ting-Ting; Mills, Mary Etta; Lin, Kuan-Chia

    2012-07-01

    A Web-based reporting system is essential to report incident events anonymously and confidentially. The purpose of this study was to evaluate a Web-based reporting system in Taiwan. User satisfaction and impact of system use were evaluated through a survey answered by 249 nurses. Incident events reported in paper and electronic systems were collected for comparison purposes. Study variables included system user satisfaction, willingness to report, number of reports, severity of the events, and efficiency of the reporting process. Results revealed that senior nurses were less willing to report events, nurses on internal medicine units had higher satisfaction than others, and lowest satisfaction was related to the time it took to file a report. In addition, the Web-based reporting system was used more often than the paper system. The percentages of events reported were significantly higher in the Web-based system in laboratory, environment/device, and incidents occurring in other units, whereas the proportions of reports involving bedsores and dislocation of endotracheal tubes were decreased. Finally, moderate injury event reporting decreased, whereas minor or minimal injury event reporting increased. The study recommends that the data entry process be simplified and the network system be improved to increase user satisfaction and reporting rates.

  5. System on chip module configured for event-driven architecture

    Science.gov (United States)

    Robbins, Kevin; Brady, Charles E.; Ashlock, Tad A.

    2017-10-17

    A system on chip (SoC) module is described herein, wherein the SoC modules comprise a processor subsystem and a hardware logic subsystem. The processor subsystem and hardware logic subsystem are in communication with one another, and transmit event messages between one another. The processor subsystem executes software actors, while the hardware logic subsystem includes hardware actors, the software actors and hardware actors conform to an event-driven architecture, such that the software actors receive and generate event messages and the hardware actors receive and generate event messages.

  6. Uranium price reporting systems

    International Nuclear Information System (INIS)

    1987-09-01

    This report describes the systems for uranium price reporting currently available to the uranium industry. The report restricts itself to prices for U 3 O 8 natural uranium concentrates. Most purchases of natural uranium by utilities, and sales by producers, are conducted in this form. The bulk of uranium in electricity generation is enriched before use, and is converted to uranium hexafluoride, UF 6 , prior to enrichment. Some uranium is traded as UF 6 or as enriched uranium, particularly in the 'secondary' market. Prices for UF 6 and enriched uranium are not considered directly in this report. However, where transactions in UF 6 influence the reported price of U 3 O 8 this influence is taken into account. Unless otherwise indicated, the terms uranium and natural uranium used here refer exclusively to U 3 O 8 . (author)

  7. National inquiry system of radiological events: a viable proposal

    International Nuclear Information System (INIS)

    Xavier, Ana Maria; Cavalcante, Vera Lucia.

    1996-01-01

    The SINAER- National Inquiry System of Radiological Events is a supportive structure devised to deal with the request of help or complaints that involve sources of ionizing radiations in the national territory

  8. Online event filtering in the JADE data acquisition system

    International Nuclear Information System (INIS)

    Mills, H.E.

    1986-01-01

    The data acquisition system developed for the JADE experiment at PETRA, DESY includes the facility to use software to filter out background events. The design, implementation, testing and experience gained are discussed. (orig.)

  9. CESAS: Computerized event sequence abstracting system outlines and applications

    International Nuclear Information System (INIS)

    Watanabe, N.; Kobayashi, K.; Fujiki, K.

    1990-01-01

    For the purpose of efficient utilization of the safety-related event information on the nuclear power plants, a new computer software package CESAS has been under development. CESAS is to systematically abstract the event sequence, that is a series of sequential and causal relationships between occurrences, from the event description written in natural language of English. This system is designed to be based on the knowledge engineering technique utilized in the field of natural language processing. The analytical process in this system consists of morphemic, syntactic, semantic, and syntagmatic analyses. At this moment, the first version of CESAS has been developed and applied to several real event descriptions for studying its feasibility. This paper describes the outlines of CESAS and one of analytical results in comparison with a manually-extracted event sequence

  10. Development and Assessment of Memorial Sloan Kettering Cancer Center’s Surgical Secondary Events Grading System

    Science.gov (United States)

    Strong, Vivian E.; Selby, Luke V.; Sovel, Mindy; Disa, Joseph J.; Hoskins, William; DeMatteo, Ronald; Scardino, Peter; Jaques, David P.

    2015-01-01

    Background Studying surgical secondary events is an evolving effort with no current established system for database design, standard reporting, or definitions. Using the Clavien-Dindo classification as a guide, in 2001 we developed a Surgical Secondary Events database based on grade of event and required intervention to begin prospectively recording and analyzing all surgical secondary events (SSE). Study Design Events are prospectively entered into the database by attending surgeons, house staff, and research staff. In 2008 we performed a blinded external audit of 1,498 operations that were randomly selected to examine the quality and reliability of the data. Results 1,498 of 4,284 operations during the 3rd quarter of 2008 were audited. 79% (N=1,180) of the operations did not have a secondary event while 21% (N=318) of operations had an identified event. 91% (1,365) of operations were correctly entered into the SSE database. 97% (129/133) of missed secondary events were Grades I and II. Three Grade III (2%) and one Grade IV (1%) secondary event were missed. There were no missed Grade 5 secondary events. Conclusion Grade III – IV events are more accurately collected than Grade I – II events. Robust and accurate secondary events data can be collected by clinicians and research staff and these data can safely be used for quality improvement projects and research. PMID:25319579

  11. Operating experience feedback report - Air systems problems

    International Nuclear Information System (INIS)

    Ornstein, H.L.

    1987-12-01

    This report highlights significant operating events involving observed or potential failures of safety-related systems in U.S. plants that resulted from degraded or malfunctioning non-safety grade air systems. Based upon the evaluation of these events, the Office for Analysis and Evaluation of Operational Data (AEOD) concludes that the issue of air systems problems is an important one which requires additional NRC and industry attention. This report also provides AEOD's recommendations for corrective actions to deal with the issue. (author)

  12. Traceability of biopharmaceuticals in spontaneous reporting systems

    DEFF Research Database (Denmark)

    Vermeer, Niels S; Straus, Sabine M J M; Mantel-Teeuwisse, Aukje K

    2013-01-01

    the period 2004-2010, including ADR reports from two major SRSs: the FDA Adverse Event Reporting System (FAERS) in the US and EudraVigilance (EV) in the EU. MAIN OUTCOME MEASURES: The availability of batch numbers was determined for biopharmaceuticals, and compared with small molecule drugs...

  13. Multi Agent System Based Wide Area Protection against Cascading Events

    DEFF Research Database (Denmark)

    Liu, Zhou; Chen, Zhe; Liu, Leo

    2012-01-01

    In this paper, a multi-agent system based wide area protection scheme is proposed in order to prevent long term voltage instability induced cascading events. The distributed relays and controllers work as a device agent which not only executes the normal function automatically but also can...... the effectiveness of proposed protection strategy. The simulation results indicate that the proposed multi agent control system can effectively coordinate the distributed relays and controllers to prevent the long term voltage instability induced cascading events....

  14. Discrete event systems in dioid algebra and conventional algebra

    CERN Document Server

    Declerck, Philippe

    2013-01-01

    This book concerns the use of dioid algebra as (max, +) algebra to treat the synchronization of tasks expressed by the maximum of the ends of the tasks conditioning the beginning of another task - a criterion of linear programming. A classical example is the departure time of a train which should wait for the arrival of other trains in order to allow for the changeover of passengers.The content focuses on the modeling of a class of dynamic systems usually called "discrete event systems" where the timing of the events is crucial. Events are viewed as sudden changes in a process which i

  15. Event tree analysis for the system of hybrid reactor

    International Nuclear Information System (INIS)

    Yang Yongwei; Qiu Lijian

    1993-01-01

    The application of probabilistic risk assessment for fusion-fission hybrid reactor is introduced. A hybrid reactor system has been analysed using event trees. According to the character of the conceptual design of Hefei Fusion-fission Experimental Hybrid Breeding Reactor, the probabilities of the event tree series induced by 4 typical initiating events were calculated. The results showed that the conceptual design is safe and reasonable. through this paper, the safety character of hybrid reactor system has been understood more deeply. Some suggestions valuable to safety design for hybrid reactor have been proposed

  16. Using Indexed and Synchronous Events to Model and Validate Cyber-Physical Systems

    Directory of Open Access Journals (Sweden)

    Chen-Wei Wang

    2015-06-01

    Full Text Available Timed Transition Models (TTMs are event-based descriptions for modelling, specifying, and verifying discrete real-time systems. An event can be spontaneous, fair, or timed with specified bounds. TTMs have a textual syntax, an operational semantics, and an automated tool supporting linear-time temporal logic. We extend TTMs and its tool with two novel modelling features for writing high-level specifications: indexed events and synchronous events. Indexed events allow for concise description of behaviour common to a set of actors. The indexing construct allows us to select a specific actor and to specify a temporal property for that actor. We use indexed events to validate the requirements of a train control system. Synchronous events allow developers to decompose simultaneous state updates into actions of separate events. To specify the intended data flow among synchronized actions, we use primed variables to reference the post-state (i.e., one resulted from taking the synchronized actions. The TTM tool automatically infers the data flow from synchronous events, and reports errors on inconsistencies due to circular data flow. We use synchronous events to validate part of the requirements of a nuclear shutdown system. In both case studies, we show how the new notation facilitates the formal validation of system requirements, and use the TTM tool to verify safety, liveness, and real-time properties.

  17. Undetected latent failures of safety-related systems. Preliminary survey of events in nuclear power plants 1980-1997

    International Nuclear Information System (INIS)

    Lydell, B.

    1998-03-01

    This report summarizes results and insights from a preliminary survey of events involving undetected, latent failures of safety-related systems. The survey was limited to events where mispositioned equipment (e.g., valves, switches) remained undetected, thus rendering standby equipment or systems unavailable for short or long time periods. Typically, these events were symptoms of underlying latent errors (e.g., design errors, procedure errors, unanalyzed safety conditions) and programmatic errors. The preliminary survey identified well over 300 events. Of these, 95 events are documented in this report. Events involving mispositioned equipment are commonplace. Most events are discovered soon after occurrence, however. But as evidenced by the survey results, some events remained undetected beyond several shift changes. The recommendations developed by the survey emphasize the importance of applying modern root cause analysis techniques to the event analysis to ensure that the causes and implications of occurred events are fully understood

  18. OSCAR experiment high-density network data report: Event 3 - April 16-17, 1981

    Energy Technology Data Exchange (ETDEWEB)

    Dana, M.T.; Easter, R.C.; Thorp, J.M.

    1984-12-01

    The OSCAR (Oxidation and Scavenging Characteristics of April Rains) experiment, conducted during April 1981, was a cooperative field investigation of wet removal in cyclonic storm systems. The high-density component of OSCAR was located in northeast Indiana and included sequential precipitation chemistry measurements on a 100 by 100 km network, as well as airborne air chemistry and cloud chemistry measurements, surface air chemistry measurements, and supporting meteorological measurements. Four separate storm events were studied during the experiment. This report summarizes data taken by Pacific Northwest Laboratory (PNL) during the third storm event, April 16-17. The report contains the high-density network precipitation chemistry data, air chemistry and cloud chemistry data from the PNL aircraft, and meteorological data for the event, including standard National Weather Service products and radar and rawindsonde data from the network. 4 references, 76 figures, 6 tables.

  19. OSCAR experiment high-density network data report: Event 1 - April 8-9, 1981

    Energy Technology Data Exchange (ETDEWEB)

    Dana, M.T.; Easter, R.C.; Thorp, J.M.

    1984-12-01

    The OSCAR (Oxidation and Scavenging Characteristics of April Rains) experiment, conducted during April 1981, was a cooperative field investigation of wet removal in cyclonic storm systems. The high-densiy component of OSCAR was located in northeast Indiana and included sequential precipitation chemistry measurements on a 100 by 100 km network, as well as airborne air chemistry and cloud chemistry measurements, surface air chemistry measurements, and supporting meteorological measurements. Four separate storm events were studied during the experiment. This report summarizes data taken by Pacific Northwest Laboratory (PNL) during the first storm event, April 8-9. The report contains the high-density network precipitation chemistry data, air chemistry data from the PNL aircraft, and meteorological data for the event, including standard National Weather Service products and radar data from the network. 4 references, 72 figures, 5 tables.

  20. Analysis of adverse events with Essure hysteroscopic sterilization reported to the Manufacturer and User Facility Device Experience database.

    Science.gov (United States)

    Al-Safi, Zain A; Shavell, Valerie I; Hobson, Deslyn T G; Berman, Jay M; Diamond, Michael P

    2013-01-01

    The Manufacturer and User Facility Device Experience database may be useful for clinicians using a Food and Drug Administration-approved medical device to identify the occurrence of adverse events and complications. We sought to analyze and investigate reports associated with the Essure hysteroscopic sterilization system (Conceptus Inc., Mountain View, CA) using this database. Retrospective review of the Manufacturer and User Facility Device Experience database for events related to Essure hysteroscopic sterilization from November 2002 to February 2012 (Canadian Task Force Classification III). Online retrospective review. Online reports of patients who underwent Essure tubal sterilization. Essure tubal sterilization. Four hundred fifty-seven adverse events were reported in the study period. Pain was the most frequently reported event (217 events [47.5%]) followed by delivery catheter malfunction (121 events [26.4%]). Poststerilization pregnancy was reported in 61 events (13.3%), of which 29 were ectopic pregnancies. Other reported events included perforation (90 events [19.7%]), abnormal bleeding (44 events [9.6%]), and microinsert malposition (33 events [7.2%]). The evaluation and management of these events resulted in an additional surgical procedure in 270 cases (59.1%), of which 44 were hysterectomies. Sixty-one unintended poststerilization pregnancies were reported in the study period, of which 29 (47.5%) were ectopic gestations. Thus, ectopic pregnancy must be considered if a woman becomes pregnant after Essure hysteroscopic sterilization. Additionally, 44 women underwent hysterectomy after an adverse event reported to be associated with the use of the device. Copyright © 2013 AAGL. Published by Elsevier Inc. All rights reserved.

  1. MedWatch, the FDA Safety Information and Adverse Event Reporting Program

    Science.gov (United States)

    ... Reporting Program MedWatch: The FDA Safety Information and Adverse Event Reporting Program Share Tweet Linkedin Pin it ... approved information that can help patients avoid serious adverse events. Potential Signals of Serious Risks/New Safety ...

  2. 77 FR 11134 - Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary...

    Science.gov (United States)

    2012-02-24

    ... organizational unit responsible for adverse event reporting compliance when these conditions exist and when the...'s current thinking on postmarketing adverse event reporting for medical products and dietary...

  3. Hierarchical Discrete Event Supervisory Control of Aircraft Propulsion Systems

    Science.gov (United States)

    Yasar, Murat; Tolani, Devendra; Ray, Asok; Shah, Neerav; Litt, Jonathan S.

    2004-01-01

    This paper presents a hierarchical application of Discrete Event Supervisory (DES) control theory for intelligent decision and control of a twin-engine aircraft propulsion system. A dual layer hierarchical DES controller is designed to supervise and coordinate the operation of two engines of the propulsion system. The two engines are individually controlled to achieve enhanced performance and reliability, necessary for fulfilling the mission objectives. Each engine is operated under a continuously varying control system that maintains the specified performance and a local discrete-event supervisor for condition monitoring and life extending control. A global upper level DES controller is designed for load balancing and overall health management of the propulsion system.

  4. Benzene Monitor System report

    International Nuclear Information System (INIS)

    Livingston, R.R.

    1992-01-01

    Two systems for monitoring benzene in aqueous streams have been designed and assembled by the Savannah River Technology Center, Analytical Development Section (ADS). These systems were used at TNX to support sampling studies of the full-scale open-quotes SRAT/SME/PRclose quotes and to provide real-time measurements of benzene in Precipitate Hydrolysis Aqueous (PHA) simulant. This report describes the two ADS Benzene Monitor System (BMS) configurations, provides data on system operation, and reviews the results of scoping tests conducted at TNX. These scoping tests will allow comparison with other benzene measurement options being considered for use in the Defense Waste Processing Facility (DWPF) laboratory. A report detailing the preferred BMS configuration statistical performance during recent tests has been issued under separate title: Statistical Analyses of the At-line Benzene Monitor Study, SCS-ASG-92-066. The current BMS design, called the At-line Benzene Monitor (ALBM), allows remote measurement of benzene in PHA solutions. The authors have demonstrated the ability to calibrate and operate this system using peanut vials from a standard Hydragard trademark sampler. The equipment and materials used to construct the ALBM are similar to those already used in other applications by the DWPF lab. The precision of this system (±0.5% Relative Standard Deviation (RSD) at 1 sigma) is better than the purge ampersand trap-gas chromatograpy reference method currently in use. Both BMSs provide a direct measurement of the benzene that can be purged from a solution with no sample pretreatment. Each analysis requires about five minutes per sample, and the system operation requires no special skills or training. The analyzer's computer software can be tailored to provide desired outputs. Use of this system produces no waste stream other than the samples themselves (i.e. no organic extractants)

  5. System risk evolution analysis and risk critical event identification based on event sequence diagram

    International Nuclear Information System (INIS)

    Luo, Pengcheng; Hu, Yang

    2013-01-01

    During system operation, the environmental, operational and usage conditions are time-varying, which causes the fluctuations of the system state variables (SSVs). These fluctuations change the accidents’ probabilities and then result in the system risk evolution (SRE). This inherent relation makes it feasible to realize risk control by monitoring the SSVs in real time, herein, the quantitative analysis of SRE is essential. Besides, some events in the process of SRE are critical to system risk, because they act like the “demarcative points” of safety and accident, and this characteristic makes each of them a key point of risk control. Therefore, analysis of SRE and identification of risk critical events (RCEs) are remarkably meaningful to ensure the system to operate safely. In this context, an event sequence diagram (ESD) based method of SRE analysis and the related Monte Carlo solution are presented; RCE and risk sensitive variable (RSV) are defined, and the corresponding identification methods are also proposed. Finally, the proposed approaches are exemplified with an accident scenario of an aircraft getting into the icing region

  6. A reliable sewage quality abnormal event monitoring system.

    Science.gov (United States)

    Li, Tianling; Winnel, Melissa; Lin, Hao; Panther, Jared; Liu, Chang; O'Halloran, Roger; Wang, Kewen; An, Taicheng; Wong, Po Keung; Zhang, Shanqing; Zhao, Huijun

    2017-09-15

    With closing water loop through purified recycled water, wastewater becomes a part of source water, requiring reliable wastewater quality monitoring system (WQMS) to manage wastewater source and mitigate potential health risks. However, the development of reliable WQMS is fatally constrained by severe contamination and biofouling of sensors due to the hostile analytical environment of wastewaters, especially raw sewages, that challenges the limit of existing sensing technologies. In this work, we report a technological solution to enable the development of WQMS for real-time abnormal event detection with high reliability and practicality. A vectored high flow hydrodynamic self-cleaning approach and a dual-sensor self-diagnostic concept are adopted for WQMS to effectively encounter vital sensor failing issues caused by contamination and biofouling and ensure the integrity of sensing data. The performance of the WQMS has been evaluated over a 3-year trial period at different sewage catchment sites across three Australian states. It has demonstrated that the developed WQMS is capable of continuously operating in raw sewage for a prolonged period up to 24 months without maintenance and failure, signifying the high reliability and practicality. The demonstrated WQMS capability to reliably acquire real-time wastewater quality information leaps forward the development of effective wastewater source management system. The reported self-cleaning and self-diagnostic concepts should be applicable to other online water quality monitoring systems, opening a new way to encounter the common reliability and stability issues caused by sensor contamination and biofouling. Copyright © 2017 Elsevier Ltd. All rights reserved.

  7. Nuclear facility safeguards systems modeling using discrete event simulation

    International Nuclear Information System (INIS)

    Engi, D.

    1977-01-01

    The threat of theft or dispersal of special nuclear material at a nuclear facility is treated by studying the temporal relationships between adversaries having authorized access to the facility (insiders) and safeguards system events by using a GASP IV discrete event simulation. The safeguards system events--detection, assessment, delay, communications, and neutralization--are modeled for the general insider adversary strategy which includes degradation of the safeguards system elements followed by an attempt to steal or disperse special nuclear material. The performance measure used in the analysis is the estimated probability of safeguards system success in countering the adversary based upon a predetermined set of adversary actions. An exemplary problem which includes generated results is presented for a hypothetical nuclear facility. The results illustrate representative information that could be utilized by safeguards decision-makers

  8. Discrete event simulation versus conventional system reliability analysis approaches

    DEFF Research Database (Denmark)

    Kozine, Igor

    2010-01-01

    Discrete Event Simulation (DES) environments are rapidly developing and appear to be promising tools for building reliability and risk analysis models of safety-critical systems and human operators. If properly developed, they are an alternative to the conventional human reliability analysis models...... and systems analysis methods such as fault and event trees and Bayesian networks. As one part, the paper describes briefly the author’s experience in applying DES models to the analysis of safety-critical systems in different domains. The other part of the paper is devoted to comparing conventional approaches...

  9. Brand vs generic adverse event reporting patterns: An authorized generic-controlled evaluation of cardiovascular medications.

    Science.gov (United States)

    Alatawi, Y; Rahman, Md M; Cheng, N; Qian, J; Peissig, P L; Berg, R L; Page, C D; Hansen, R A

    2018-06-01

    Some public scepticism exists about generics in terms of whether brand and generic drugs produce identical outcomes. This study explores whether adverse event (AE) reporting patterns are similar between brand and generic drugs, using authorized generics (AGs) as a control for possible generic drug perception biases. Events reported to the FDA Adverse Event Reporting System from the years 2004-2015 were analysed. Drugs were classified as brand, AG or generic based on drug and manufacturer names. Reports were included if amlodipine, losartan, metoprolol extended release (ER) or simvastatin were listed as primary or secondary suspect drugs. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting labelled AEs compared to reporting these AEs with all other drugs. The Breslow-Day test compared RORs across brand, AG and generic. Interrupted time series analysis evaluated the impact of generic entry on reporting trends. Generics accounted for significant percentages of total U.S. reports, but AGs accounted for smaller percentages of reports, including for amlodipine (14.26%), losartan (1.48%), metoprolol ER (0.35%) and simvastatin (0.70%). Whereas the RORs were significantly different for multiple brand vs generic comparisons, the AG vs generic comparisons yielded fewer statistically significant findings. Namely, only the ROR for AG differed from generic for amlodipine with peripheral oedema (P brand and generic compared with AG and generic. Use of AGs as a control for perception biases against generics is useful, but this approach can be limited by small AG report numbers. Requiring the manufacturer name to be printed on the prescription bottle or packaging could improve the accuracy of assignment for products being reported. © 2017 John Wiley & Sons Ltd.

  10. Modelling machine ensembles with discrete event dynamical system theory

    Science.gov (United States)

    Hunter, Dan

    1990-01-01

    Discrete Event Dynamical System (DEDS) theory can be utilized as a control strategy for future complex machine ensembles that will be required for in-space construction. The control strategy involves orchestrating a set of interactive submachines to perform a set of tasks for a given set of constraints such as minimum time, minimum energy, or maximum machine utilization. Machine ensembles can be hierarchically modeled as a global model that combines the operations of the individual submachines. These submachines are represented in the global model as local models. Local models, from the perspective of DEDS theory , are described by the following: a set of system and transition states, an event alphabet that portrays actions that takes a submachine from one state to another, an initial system state, a partial function that maps the current state and event alphabet to the next state, and the time required for the event to occur. Each submachine in the machine ensemble is presented by a unique local model. The global model combines the local models such that the local models can operate in parallel under the additional logistic and physical constraints due to submachine interactions. The global model is constructed from the states, events, event functions, and timing requirements of the local models. Supervisory control can be implemented in the global model by various methods such as task scheduling (open-loop control) or implementing a feedback DEDS controller (closed-loop control).

  11. Security information and event management systems: benefits and inefficiencies

    OpenAIRE

    Κάτσαρης, Δημήτριος Σ.

    2014-01-01

    In this Master’s thesis, the new trend in computer and information security industry called Security Information and Event Management systems will be covered. The evolution, advantages and weaknesses of these systems will be described, as well as a home-based implementation with open source tools will be proposed and implemented.

  12. Importance of reportable events with regard to public acceptance

    International Nuclear Information System (INIS)

    Wehner, G.

    1983-01-01

    Although risk assessments have shown that the transport of radioactive material (RAM) only contributes a very small part of the overall risk of nuclear energy, the public is still concerned about the safety of these transport operations. This is due to the fact that during such an operation RAM may come in the vicinity of everybody and that most people are familiar with the effects of ordinary transport accidents. It is therefore important to achieve public acceptance, that means, to convince the public that transport of RAM is really safe. Four points are of special importance in this connection: (1) information of the public about the safety philosophy and the radiation protection principles developed by the International Atomic Energy Agency (IAEA) for the transport of RAM. The planned edition of explanatory material to the IAEA Safety Series No. 6 - the so-called why document - is very important for this point; (2) information about the average and maximal individual annual doses for members of the public from normal transport of RAM; (3) information of the public about accident experiences in transport of RAM and the excellent safety standard reached in this field; and (4) information of the public about the extent and the results of governmental controls in this field. In the Federal Republic of Germany the states are requested to report to the Federal Ministry of the Interior all special events occurring during handling and carriage of RAM. The main purpose of these reports is to inform the competent authorities and to draw - if necessary - the conclusion for the improvement of protective measures

  13. Towards the creation of a flexible classification scheme for voluntarily reported transfusion and laboratory safety events.

    Science.gov (United States)

    Whitehurst, Julie M; Schroder, John; Leonard, Dave; Horvath, Monica M; Cozart, Heidi; Ferranti, Jeffrey

    2012-05-18

    Transfusion and clinical laboratory services are high-volume activities involving complicated workflows across both ambulatory and inpatient environments. As a result, there are many opportunities for safety lapses, leading to patient harm and increased costs. Organizational techniques such as voluntary safety event reporting are commonly used to identify and prioritize risk areas across care settings. Creation of functional, standardized safety data structures that facilitate effective exploratory examination is therefore essential to drive quality improvement interventions. Unfortunately, voluntarily reported adverse event data can often be unstructured or ambiguously defined. To address this problem, we sought to create a "best-of-breed" patient safety classification for data contained in the Duke University Health System Safety Reporting System (SRS). Our approach was to implement the internationally recognized World Health Organization International Classification for Patient Safety Framework, supplemented with additional data points relevant to our organization. Data selection and integration into the hierarchical framework is discussed, as well as placement of the classification into the SRS. We evaluated the impact of the new SRS classification on system usage through comparisons of monthly average report rates and completion times before and after implementation. Monthly average inpatient transfusion reports decreased from 102.1 ± 14.3 to 91.6 ± 11.2, with the proportion of transfusion reports in our system remaining consistent before and after implementation. Monthly average transfusion report rates in the outpatient and homecare environments were not significantly different. Significant increases in clinical lab report rates were present across inpatient and outpatient environments, with the proportion of lab reports increasing after implementation. Report completion times increased modestly but not significantly from a practical standpoint. A

  14. Impact of High-Reliability Education on Adverse Event Reporting by Registered Nurses.

    Science.gov (United States)

    McFarland, Diane M; Doucette, Jeffrey N

    Adverse event reporting is one strategy to identify risks and improve patient safety, but, historically, adverse events are underreported by registered nurses (RNs) because of fear of retribution and blame. A program was provided on high reliability to examine whether education would impact RNs' willingness to report adverse events. Although the findings were not statistically significant, they demonstrated a positive impact on adverse event reporting and support the need to create a culture of high reliability.

  15. Spontaneous Adverse Event Reports Associated with Zolpidem in the United States 2003–2012

    Science.gov (United States)

    Wong, Carmen K.; Marshall, Nathaniel S.; Grunstein, Ronald R.; Ho, Samuel S.; Fois, Romano A.; Hibbs, David E.; Hanrahan, Jane R.; Saini, Bandana

    2017-01-01

    Study Objectives: Stimulated reporting occurs when patients and healthcare professionals are influenced or “stimulated” by media publicity to report specific drug-related adverse reactions, significantly biasing pharmacovigilance analyses. Among countries where the non-benzodiazepine hypnotic drug zolpidem is marketed, the United States experienced a comparable surge of media reporting during 2006–2009 linking the above drug with the development of complex neuropsychiatric sleep-related behaviors. However, the effect of this stimulated reporting in the United States Food and Drug Administration Adverse Event Reporting System has not been explored. Methods: Using disproportionality analyses, reporting odds ratios for zolpidem exposure and the following adverse events; parasomnia, movement-based parasomnia, nonmovement-based parasomnia, amnesia, hallucination, and suicidality were determined and compared to all other medications in the database, followed by specific comparison to the benzodiazepine hypnotic class, year-by-year from 2003 to 2012. Results: Odds ratios were increased significantly during and after the period of media publicity for parasomnias, movement-based parasomnias, amnesias and hallucinations. We also observed that zolpidem adverse drug reaction (ADR) reports have higher odds for parasomnias, movement-based parasomnias, amnesias, hallucinations, and suicidality compared to all other drugs, even before the media publicity cluster. Conclusions: Although our results indicate that zolpidem reports have higher odds for the ADR of interest even before the media publicity cluster, negative media coverage greatly exacerbated the reporting of these adverse reactions. The effect of such reporting must be borne in mind when decisions around drugs which have been the subject of intense media publicity are made by health professionals or regulatory bodies. Citation: Wong CK, Marshall NS, Grunstein RR, Ho SS, Fois RA, Hibbs DE, Hanrahan JR, Saini B

  16. Analysis of system and of course of events

    International Nuclear Information System (INIS)

    Hoertner, H.; Kersting, E.J.; Puetter, B.M.

    1986-01-01

    The analysis of the system and of the course of events is used to determine the frequency of core melt-out accidents and to describe the safety-related boundary conditions of appropriate accidents. The lecture is concerned with the effect of system changes in the reference plant and the effect of triggering events not assessed in detail or not sufficiently assessed in detail in phase A of the German Risk Study on the frequency of core melt-out accidents, the minimum requirements for system functions for controlling triggering events, i.e. to prevent core melt-out accidents, the reliability data important for reliability investigations and frequency assessments. (orig./DG) [de

  17. Event-triggered output feedback control for distributed networked systems.

    Science.gov (United States)

    Mahmoud, Magdi S; Sabih, Muhammad; Elshafei, Moustafa

    2016-01-01

    This paper addresses the problem of output-feedback communication and control with event-triggered framework in the context of distributed networked control systems. The design problem of the event-triggered output-feedback control is proposed as a linear matrix inequality (LMI) feasibility problem. The scheme is developed for the distributed system where only partial states are available. In this scheme, a subsystem uses local observers and share its information to its neighbors only when the subsystem's local error exceeds a specified threshold. The developed method is illustrated by using a coupled cart example from the literature. Copyright © 2015 ISA. Published by Elsevier Ltd. All rights reserved.

  18. Nitrated nucleosome levels and neuropsychiatric events in systemic lupus erythematosus;

    DEFF Research Database (Denmark)

    Ferreira, Isabel; Croca, Sara; Raimondo, Maria Gabriella

    2017-01-01

    BACKGROUND: In patients with systemic lupus erythematosus (SLE) there is no serological test that will reliably distinguish neuropsychiatric (NP) events due to active SLE from those due to other causes. Previously we showed that serum levels of nitrated nucleosomes (NN) were elevated in a small...... number of patients with NPSLE. Here we measured serum NN in samples from a larger population of patients with SLE and NP events to see whether elevated serum NN could be a marker for NPSLE. METHODS: We obtained serum samples from patients in the Systemic Lupus International Collaborative Clinics (SLICC...

  19. Mixed Methods Analysis of Medical Error Event Reports: A Report from the ASIPS Collaborative

    National Research Council Canada - National Science Library

    Harris, Daniel M; Westfall, John M; Fernald, Douglas H; Duclos, Christine W; West, David R; Niebauer, Linda; Marr, Linda; Quintela, Javan; Main, Deborah S

    2005-01-01

    The Applied Strategies for Improving Patient Safety (ASIPS) collaborative developed an ambulatory primary care patient safety reporting system through an Agency for Healthcare Research and Quality (AHRQ...

  20. Events

    Directory of Open Access Journals (Sweden)

    Igor V. Karyakin

    2016-02-01

    Full Text Available The 9th ARRCN Symposium 2015 was held during 21st–25th October 2015 at the Novotel Hotel, Chumphon, Thailand, one of the most favored travel destinations in Asia. The 10th ARRCN Symposium 2017 will be held during October 2017 in the Davao, Philippines. International Symposium on the Montagu's Harrier (Circus pygargus «The Montagu's Harrier in Europe. Status. Threats. Protection», organized by the environmental organization «Landesbund für Vogelschutz in Bayern e.V.» (LBV was held on November 20-22, 2015 in Germany. The location of this event was the city of Wurzburg in Bavaria.

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

    Science.gov (United States)

    Hong, Su; Li, QiuJie

    2017-04-01

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

  2. Asynchronous sampled-data approach for event-triggered systems

    Science.gov (United States)

    Mahmoud, Magdi S.; Memon, Azhar M.

    2017-11-01

    While aperiodically triggered network control systems save a considerable amount of communication bandwidth, they also pose challenges such as coupling between control and event-condition design, optimisation of the available resources such as control, communication and computation power, and time-delays due to computation and communication network. With this motivation, the paper presents separate designs of control and event-triggering mechanism, thus simplifying the overall analysis, asynchronous linear quadratic Gaussian controller which tackles delays and aperiodic nature of transmissions, and a novel event mechanism which compares the cost of the aperiodic system against a reference periodic implementation. The proposed scheme is simulated on a linearised wind turbine model for pitch angle control and the results show significant improvement against the periodic counterpart.

  3. Selection of initial events of accelerator driven subcritical system

    International Nuclear Information System (INIS)

    Wang Qianglong; Hu Liqin; Wang Jiaqun; Li Yazhou; Yang Zhiyi

    2013-01-01

    The Probabilistic Safety Assessment (PSA) is an important tool in reactor safety analysis and a significant reference to the design and operation of reactor. It is the origin and foundation of the PSA for a reactor to select the initial events. Accelerator Driven Subcritical System (ADS) has advanced design characteristics, complicated subsystems and little engineering and operating experience, which makes it much more difficult to identify the initial events of ADS. Based on the current design project of ADS, the system's safety characteristics and special issues were analyzed in this article. After a series of deductions with Master Logic Diagram (MLD) and considering the relating experience of other advanced research reactors, a preliminary initial events was listed finally, which provided the foundation for the next safety assessment. (authors)

  4. Developing Fluorescence Sensor Systems for Early Detection of Nitrification Events in Chloraminated Drinking Water Distribution Systems

    Science.gov (United States)

    Detection of nitrification events in chloraminated drinking water distribution systems remains an ongoing challenge for many drinking water utilities, including Dallas Water Utilities (DWU) and the City of Houston (CoH). Each year, these utilities experience nitrification events ...

  5. The Hidden Cost of Regulation: The Administrative Cost of Reporting Serious Reportable Events.

    Science.gov (United States)

    Blanchfield, Bonnie B; Acharya, Bijay; Mort, Elizabeth

    2018-04-01

    More than half of the 50 states (27) and the District of Columbia require reporting of Serous Reportable Events (SREs). The goal is to hold providers accountable and improve patient safety, but there is little information about the administrative cost of this reporting requirement. This study was conducted to identify costs associated with investigating and reporting SREs. This qualitative study used case study methods that included interviewing staff and review of data and documents to investigate each SRE occurring at one academic medical center during fiscal year 2013. A framework of tasks and a model to categorize costs was created. Time was summarized and costs were estimated for each SRE. The administrative cost to process 44 SREs was estimated at $353,291, an average cost of $8,029 per SRE, ranging $6,653 for an environmental-related SRE to $21,276 for a device-related SRE. Care management SREs occurred most frequently, costing an average $7,201 per SRE. Surgical SREs, the most expensive on average, cost $9,123 per SRE. Investigation of events accounted for 64.5% of total cost; public reporting, 17.2%; internal reporting, 10.2%; finance and administration, 6.0%; and 2.1%, other. Even with 26 states mandating reporting, the 17.2% incremental cost of public reporting is substantial. Policy makers should consider the opportunity costs of these resources, averaging $8,029 per SRE, when mandating reporting. The benefits of public reporting should be collectively reviewed to ensure that the incremental costs in this resource-constrained environment continue to improve patient safety and that trade-offs are acknowledged. Copyright © 2017 The Joint Commission. Published by Elsevier Inc. All rights reserved.

  6. Hybrid modelling in discrete-event control system design

    NARCIS (Netherlands)

    Beek, van D.A.; Rooda, J.E.; Gordijn, S.H.F.; Borne, P.

    1996-01-01

    Simulation-based testing of discrete-event control systems can be advantageous. There is, however, a considerable difference between languages for real-time control and simulation languages. The Chi language, presented in this paper, is suited to specification and simulation of real-time control

  7. Modular Control of Discrete-Event Systems with Coalgebra

    Czech Academy of Sciences Publication Activity Database

    Komenda, Jan; van Schuppen, J. H.

    2008-01-01

    Roč. 53, č. 2 (2008), s. 447-460 ISSN 0018-9286 R&D Projects: GA AV ČR(CZ) KJB100190609 Institutional research plan: CEZ:AV0Z10190503 Keywords : discrete-event systems * modular supervisory control * coalgebra Subject RIV: BA - General Mathematics Impact factor: 3.293, year: 2008

  8. Designing and Securing an Event Processing System for Smart Spaces

    Science.gov (United States)

    Li, Zang

    2011-01-01

    Smart spaces, or smart environments, represent the next evolutionary development in buildings, banking, homes, hospitals, transportation systems, industries, cities, and government automation. By riding the tide of sensor and event processing technologies, the smart environment captures and processes information about its surroundings as well as…

  9. Event-triggered control systems under packet losses

    NARCIS (Netherlands)

    Dolk, V.S.; Heemels, W.P.M.H.

    2017-01-01

    Networked control systems (NCSs) offer many benefits in terms of increased flexibility and maintainability but might also suffer from inevitable imperfections such as packet dropouts and limited communications resources. In this paper, (static and dynamic) event-triggered control (ETC) strategies

  10. Non-Lipschitz Dynamics Approach to Discrete Event Systems

    Science.gov (United States)

    Zak, M.; Meyers, R.

    1995-01-01

    This paper presents and discusses a mathematical formalism for simulation of discrete event dynamics (DED) - a special type of 'man- made' system designed to aid specific areas of information processing. A main objective is to demonstrate that the mathematical formalism for DED can be based upon the terminal model of Newtonian dynamics which allows one to relax Lipschitz conditions at some discrete points.

  11. Software for event oriented processing on multiprocessor systems

    International Nuclear Information System (INIS)

    Fischler, M.; Areti, H.; Biel, J.; Bracker, S.; Case, G.; Gaines, I.; Husby, D.; Nash, T.

    1984-08-01

    Computing intensive problems that require the processing of numerous essentially independent events are natural customers for large scale multi-microprocessor systems. This paper describes the software required to support users with such problems in a multiprocessor environment. It is based on experience with and development work aimed at processing very large amounts of high energy physics data

  12. Designing adverse event forms for real-world reporting: participatory research in Uganda.

    Science.gov (United States)

    Davies, Emma C; Chandler, Clare I R; Innocent, Simeon H S; Kalumuna, Charles; Terlouw, Dianne J; Lalloo, David G; Staedke, Sarah G; Haaland, Ane

    2012-01-01

    The wide-scale roll-out of artemisinin combination therapies (ACTs) for the treatment of malaria should be accompanied by continued surveillance of their safety. Post-marketing pharmacovigilance (PV) relies on adverse event (AE) reporting by clinicians, but as a large proportion of treatments are provided by non-clinicians in low-resource settings, the effectiveness of such PV systems is limited. To facilitate reporting, AE forms should be easily completed; however, most are challenging for lower-level health workers and non-clinicians to complete. Through participatory research, we sought to develop user-friendly AE report forms to capture information on events associated with ACTs.Following situation analysis, we undertook workshops with community medicine distributors and health workers in Jinja, Uganda, to develop a reporting form based on experiences and needs of users, and communication and visual perception principles. Participants gave feedback for revisions of subsequent versions. We then conducted 8 pretesting sessions with 77 potential end users to test and refine passive and active versions of the form.The development process resulted in a form that included a pictorial storyboard to communicate the rationale for the information needed and facilitate rapport between the reporter and the respondent, and a diary format to record the drug administration and event details in chronological relation to each other. Successive rounds of pretesting used qualitative and quantitative feedback to refine the form, with the final round showing over 80% of the form completed correctly by potential end users.We developed novel AE report forms that can be used by non-clinicians to capture pharmacovigilance data for anti-malarial drugs. The participatory approach was effective for developing forms that are intuitive for reporters, and motivating for respondents. The forms, or their key components, could be adapted for use in other low-literacy settings to improve quality

  13. Designing adverse event forms for real-world reporting: participatory research in Uganda.

    Directory of Open Access Journals (Sweden)

    Emma C Davies

    Full Text Available The wide-scale roll-out of artemisinin combination therapies (ACTs for the treatment of malaria should be accompanied by continued surveillance of their safety. Post-marketing pharmacovigilance (PV relies on adverse event (AE reporting by clinicians, but as a large proportion of treatments are provided by non-clinicians in low-resource settings, the effectiveness of such PV systems is limited. To facilitate reporting, AE forms should be easily completed; however, most are challenging for lower-level health workers and non-clinicians to complete. Through participatory research, we sought to develop user-friendly AE report forms to capture information on events associated with ACTs.Following situation analysis, we undertook workshops with community medicine distributors and health workers in Jinja, Uganda, to develop a reporting form based on experiences and needs of users, and communication and visual perception principles. Participants gave feedback for revisions of subsequent versions. We then conducted 8 pretesting sessions with 77 potential end users to test and refine passive and active versions of the form.The development process resulted in a form that included a pictorial storyboard to communicate the rationale for the information needed and facilitate rapport between the reporter and the respondent, and a diary format to record the drug administration and event details in chronological relation to each other. Successive rounds of pretesting used qualitative and quantitative feedback to refine the form, with the final round showing over 80% of the form completed correctly by potential end users.We developed novel AE report forms that can be used by non-clinicians to capture pharmacovigilance data for anti-malarial drugs. The participatory approach was effective for developing forms that are intuitive for reporters, and motivating for respondents. The forms, or their key components, could be adapted for use in other low-literacy settings

  14. Abstracting event-based control models for high autonomy systems

    Science.gov (United States)

    Luh, Cheng-Jye; Zeigler, Bernard P.

    1993-01-01

    A high autonomy system needs many models on which to base control, management, design, and other interventions. These models differ in level of abstraction and in formalism. Concepts and tools are needed to organize the models into a coherent whole. The paper deals with the abstraction processes for systematic derivation of related models for use in event-based control. The multifaceted modeling methodology is briefly reviewed. The morphism concepts needed for application to model abstraction are described. A theory for supporting the construction of DEVS models needed for event-based control is then presented. An implemented morphism on the basis of this theory is also described.

  15. An ATLAS event with a high mass dijet system

    CERN Multimedia

    ATLAS, Experiment

    2014-01-01

    Event with a high mass dijet system: the invariant mass of the two highest-pT jets is 2.55 TeV. The highest pT jet has a pT of 420 GeV, and an eta of -1.51, the second leading jet has pT of 320 GeV and an eta of 2.32. Jet momenta are calibrated according to the "EM+JES" scheme. No other jets are found with pT above 20 GeV. Event collected on 4 July 2010.

  16. Fuels Reporting System Data

    Data.gov (United States)

    U.S. Environmental Protection Agency — This asset includes compliance data (registrations and reports), including reports related to reformulated gasoline and conventional gasoline (anti-dumping),...

  17. Event-Triggered Fault Detection of Nonlinear Networked Systems.

    Science.gov (United States)

    Li, Hongyi; Chen, Ziran; Wu, Ligang; Lam, Hak-Keung; Du, Haiping

    2017-04-01

    This paper investigates the problem of fault detection for nonlinear discrete-time networked systems under an event-triggered scheme. A polynomial fuzzy fault detection filter is designed to generate a residual signal and detect faults in the system. A novel polynomial event-triggered scheme is proposed to determine the transmission of the signal. A fault detection filter is designed to guarantee that the residual system is asymptotically stable and satisfies the desired performance. Polynomial approximated membership functions obtained by Taylor series are employed for filtering analysis. Furthermore, sufficient conditions are represented in terms of sum of squares (SOSs) and can be solved by SOS tools in MATLAB environment. A numerical example is provided to demonstrate the effectiveness of the proposed results.

  18. Internal event analysis of Laguna Verde Unit 1 Nuclear Power Plant. System Analysis

    International Nuclear Information System (INIS)

    Huerta B, A.; Aguilar T, O.; Nunez C, A.; Lopez M, R.

    1993-01-01

    The Level 1 results of Laguna Verde Nuclear Power Plant PRA are presented in the I nternal Event Analysis of Laguna Verde Unit 1 Nuclear Power Plant , CNSNS-TR-004, in five volumes. The reports are organized as follows: CNSNS-TR-004 Volume 1: Introduction and Methodology. CNSNS-TR-004 Volume 2: Initiating Event and Accident Sequences. CNSNS-TR-004 Volume 3: System Analysis. CNSNS-TR-004 Volume 4: Accident Sequence Quantification and Results. CNSNS-TR-004 Volume 5: Appendices A, B and C. This volume presents the results of the system analysis for the Laguna Verde Unit 1 Nuclear Power Plant. The system analysis involved the development of logical models for all the systems included in the accident sequence event tree headings, and for all the support systems required to operate the front line systems. For the Internal Event analysis for Laguna Verde, 16 front line systems and 5 support systems were included. Detailed fault trees were developed for most of the important systems. Simplified fault trees focusing on major faults were constructed for those systems that can be adequately represent,ed using this kind of modeling. For those systems where fault tree models were not constructed, actual data were used to represent the dominant failures of the systems. The main failures included in the fault trees are hardware failures, test and maintenance unavailabilities, common cause failures, and human errors. The SETS and TEMAC codes were used to perform the qualitative and quantitative fault tree analyses. (Author)

  19. Safety Discrete Event Models for Holonic Cyclic Manufacturing Systems

    Science.gov (United States)

    Ciufudean, Calin; Filote, Constantin

    In this paper the expression “holonic cyclic manufacturing systems” refers to complex assembly/disassembly systems or fork/join systems, kanban systems, and in general, to any discrete event system that transforms raw material and/or components into products. Such a system is said to be cyclic if it provides the same sequence of products indefinitely. This paper considers the scheduling of holonic cyclic manufacturing systems and describes a new approach using Petri nets formalism. We propose an approach to frame the optimum schedule of holonic cyclic manufacturing systems in order to maximize the throughput while minimize the work in process. We also propose an algorithm to verify the optimum schedule.

  20. Frequencies and trends of significant characteristics of reported events in Germany

    International Nuclear Information System (INIS)

    Farber, G.; Matthes, H.

    2001-01-01

    In the frame of its support to the German Federal Ministry for the Environment, Nature Conservation and Nuclear Safety the GRS continuously performs in-depth technical analyses of reported events at operating nuclear power reactors in Germany which can be used for the determination of plant weaknesses with regard to reactor safety. During the last 18 months, in addition to those activities, the GRS has developed a data bank model for the statistical assessment of events. This model is based on a hierarchically structured, detailed coding system with respect to technical and safety relevant characteristics of the plants and the systematic characterization of plant-specific events. The data bank model is ready for practical application. Results of a first statistical evaluation, taking into account the data sets from the time period 1996 to 1999, are meanwhile available. By increasing the amount of data it will become possible to herewith improve the statements concerning trends of safety aspects. This report describes the coding system, the evaluation model, the data input and the evaluations performed during the period beginning in April 2000. (authors)

  1. Frequencies and trends of significant characteristics of reported events in Germany

    Energy Technology Data Exchange (ETDEWEB)

    Farber, G.; Matthes, H. [Gesellschaft fuer Anlagen- und Reaktorsicherheit (GRS) mbH, Koln (Germany)

    2001-07-01

    In the frame of its support to the German Federal Ministry for the Environment, Nature Conservation and Nuclear Safety the GRS continuously performs in-depth technical analyses of reported events at operating nuclear power reactors in Germany which can be used for the determination of plant weaknesses with regard to reactor safety. During the last 18 months, in addition to those activities, the GRS has developed a data bank model for the statistical assessment of events. This model is based on a hierarchically structured, detailed coding system with respect to technical and safety relevant characteristics of the plants and the systematic characterization of plant-specific events. The data bank model is ready for practical application. Results of a first statistical evaluation, taking into account the data sets from the time period 1996 to 1999, are meanwhile available. By increasing the amount of data it will become possible to herewith improve the statements concerning trends of safety aspects. This report describes the coding system, the evaluation model, the data input and the evaluations performed during the period beginning in April 2000. (authors)

  2. Spontaneous Adverse Event Reports Associated with Zolpidem in the United States 2003-2012.

    Science.gov (United States)

    Wong, Carmen K; Marshall, Nathaniel S; Grunstein, Ronald R; Ho, Samuel S; Fois, Romano A; Hibbs, David E; Hanrahan, Jane R; Saini, Bandana

    2017-02-15

    Stimulated reporting occurs when patients and healthcare professionals are influenced or "stimulated" by media publicity to report specific drug-related adverse reactions, significantly biasing pharmacovigilance analyses. Among countries where the non-benzodiazepine hypnotic drug zolpidem is marketed, the United States experienced a comparable surge of media reporting during 2006-2009 linking the above drug with the development of complex neuropsychiatric sleep-related behaviors. However, the effect of this stimulated reporting in the United States Food and Drug Administration Adverse Event Reporting System has not been explored. Using disproportionality analyses, reporting odds ratios for zolpidem exposure and the following adverse events; parasomnia, movement-based parasomnia, nonmovement-based parasomnia, amnesia, hallucination, and suicidality were determined and compared to all other medications in the database, followed by specific comparison to the benzodiazepine hypnotic class, year-by-year from 2003 to 2012. Odds ratios were increased significantly during and after the period of media publicity for parasomnias, movement-based parasomnias, amnesias and hallucinations. We also observed that zolpidem adverse drug reaction (ADR) reports have higher odds for parasomnias, movement-based parasomnias, amnesias, hallucinations, and suicidality compared to all other drugs, even before the media publicity cluster. Although our results indicate that zolpidem reports have higher odds for the ADR of interest even before the media publicity cluster, negative media coverage greatly exacerbated the reporting of these adverse reactions. The effect of such reporting must be borne in mind when decisions around drugs which have been the subject of intense media publicity are made by health professionals or regulatory bodies. © 2017 American Academy of Sleep Medicine

  3. Safety management as a foundation for evidence-based aeromedical standards and reporting of medical events.

    Science.gov (United States)

    Evans, Anthony D; Watson, Dougal B; Evans, Sally A; Hastings, John; Singh, Jarnail; Thibeault, Claude

    2009-06-01

    The different interpretations by States (countries) of the aeromedical standards established by the International Civil Aviation Organization has resulted in a variety of approaches to the development of national aeromedical policy, and consequently a relative lack of harmonization. However, in many areas of aviation, safety management systems have been recently introduced and may represent a way forward. A safety management system can be defined as "A systematic approach to managing safety, including the necessary organizational structures, accountabilities, policies, and procedures" (1). There are four main areas where, by applying safety management principles, it may be possible to better use aeromedical data to enhance flight safety. These are: 1) adjustment of the periodicity and content of routine medical examinations to more accurately reflect aeromedical risk; 2) improvement in reporting and analysis of routine medical examination data; 3) improvement in reporting and analysis of in-flight medical events; and 4) support for improved reporting of relevant aeromedical events through the promotion of an appropriate culture by companies and regulatory authorities. This paper explores how the principles of safety management may be applied to aeromedical systems to improve their contribution to safety.

  4. Medication incidents reported to an online incident reporting system.

    LENUS (Irish Health Repository)

    Alrwisan, Adel

    2011-01-15

    AIMS: Approximately 20% of deaths from adverse events are related to medication incidents, costing the NHS an additional £500 million annually. Less than 5% of adverse events are reported. This study aims to assess the reporting rate of medication incidents in NHS facilities in the north east of Scotland, and to describe the types and outcomes of reported incidents among different services. Furthermore, we wished to quantify the proportion of reported incidents according to the reporters\\' profession. METHODS: A retrospective description was made of medication incidents reported to an online reporting system (DATIX) over a 46-month-period (July 2005 to April 2009). Reports originated from acute and community hospitals, mental health, and primary care facilities. RESULTS: Over the study period there were 2,666 incidents reported with a mean monthly reporting rate of 78.2\\/month (SD±16.9). 6.1% of all incidents resulted in harm, with insulin being the most commonly implicated medication. Nearly three-quarters (74.2%, n=1,978) of total incidents originated from acute hospitals. Administration incidents were implicated in the majority of the reported medication incidents (59%), followed by prescribing (10.8%) and dispensing (9.9%), while the nondescript "other medication incidents" accounted for 20.3% of total incidents. The majority of reports were made by nursing and midwifery staff (80%), with medical and dental professionals reporting the lowest number of incidents (n=56, 2%). CONCLUSIONS: The majority of medication incidents in this study were reported by nursing and midwifery staff, and were due to administration incidents. There is a clear need to elucidate the reasons for the limited contribution of the medical and dental professionals to reporting medication incidents.

  5. Physician Quality Reporting System

    Data.gov (United States)

    U.S. Department of Health & Human Services — PQRS is a reporting program that uses a combination of incentive payments and negative payment adjustments to promote reporting of quality information by eligible...

  6. Selective Attention in Multi-Chip Address-Event Systems

    Directory of Open Access Journals (Sweden)

    Giacomo Indiveri

    2009-06-01

    Full Text Available Selective attention is the strategy used by biological systems to cope with the inherent limits in their available computational resources, in order to efficiently process sensory information. The same strategy can be used in artificial systems that have to process vast amounts of sensory data with limited resources. In this paper we present a neuromorphic VLSI device, the “Selective Attention Chip” (SAC, which can be used to implement these models in multi-chip address-event systems. We also describe a real-time sensory-motor system, which integrates the SAC with a dynamic vision sensor and a robotic actuator. We present experimental results from each component in the system, and demonstrate how the complete system implements a real-time stimulus-driven selective attention model.

  7. Selective attention in multi-chip address-event systems.

    Science.gov (United States)

    Bartolozzi, Chiara; Indiveri, Giacomo

    2009-01-01

    Selective attention is the strategy used by biological systems to cope with the inherent limits in their available computational resources, in order to efficiently process sensory information. The same strategy can be used in artificial systems that have to process vast amounts of sensory data with limited resources. In this paper we present a neuromorphic VLSI device, the "Selective Attention Chip" (SAC), which can be used to implement these models in multi-chip address-event systems. We also describe a real-time sensory-motor system, which integrates the SAC with a dynamic vision sensor and a robotic actuator. We present experimental results from each component in the system, and demonstrate how the complete system implements a real-time stimulus-driven selective attention model.

  8. An abnormal event advisory expert system prototype for reactor operators

    International Nuclear Information System (INIS)

    Hance, D.C.

    1989-01-01

    Nuclear plant operators must respond correctly during abnormal conditions in the presence of dynamic and potentially overwhelming volumes of information. For this reason, considerable effort has been directed toward the development of nuclear plant operator aids using artificial intelligence techniques. The objective of such systems is to diagnose abnormal conditions within the plant, possibly predict consequences, and advise the operators of corrective actions in a timely manner. The objective of the work is the development of a prototype expert system to diagnose abnormal events at a nuclear power plant and advise plant operators of the event and applicable procedures in an on-line mode. The major difference between this effort and previous work is the use of plant operating procedures as a knowledge source and as an integral part of the advice provided by the expert system. The acceptance by utilities of expert systems as operator aids requires that such systems be compatible with the regulatory environment and provide economic benefits. For this reason, commercially viable operator aid systems developed in the near future must complement existing plant procedures rather than reach beyond them in a revolutionary manner. A knowledge source is the resource providing facts and relationships that are coded into the expert system program. In this case, the primary source of knowledge is a set of selected abnormal operating procedures for a modern Westinghouse pressurized water reactor

  9. Active surveillance for influenza vaccine adverse events: the integrated vaccine surveillance system.

    Science.gov (United States)

    Newes-Adeyi, Gabriella; Greece, Jacey; Bozeman, Sam; Walker, Deborah Klein; Lewis, Faith; Gidudu, Jane

    2012-02-01

    We conducted a pilot study of the Integrated Vaccine Surveillance System (IVSS), a novel active surveillance system for monitoring influenza vaccine adverse events that could be used in mass vaccination settings. We recruited 605 adult vaccinees from a convenience sample of 12 influenza vaccine clinics conducted by public health departments of two U.S. metropolitan regions. Vaccinees provided daily reports on adverse reactions following immunization (AEFI) using an interactive voice response system (IVR) or the internet for 14 consecutive days following immunization. Followup with nonrespondents was conducted through computer-assisted telephone interviewing (CATI). Data on vaccinee reports were available real-time through a dedicated secure website. 90% (545) of vaccinees made at least one daily report and 49% (299) reported consecutively for the full 14-day period. 58% (315) used internet, 20% (110) IVR, 6% (31) CATI, and 16% (89) used a combination for daily reports. Of the 545 reporters, 339 (62%) reported one or more AEFI, for a total of 594 AEFIs reported. The majority (505 or 85%) of these AEFIs were mild symptoms. It is feasible to develop a system to obtain real-time data on vaccine adverse events. Vaccinees are willing to provide daily reports for a considerable time post vaccination. Offering multiple modes of reporting encourages high response rates. Study findings on AEFIs showed that the IVSS was able to exhibit the emerging safety profile of the 2008 seasonal influenza vaccine. Copyright © 2011 Elsevier Ltd. All rights reserved.

  10. Development of INSTEC(INformation System of Trip Event Cases)

    International Nuclear Information System (INIS)

    Lee, Jeong Woon; Shim, Bong Sik; Park, Keun Oak; Cheon, Se Woo

    1996-09-01

    In this research, we established an incident analysis procedure based on the concept of interaction between plant components and developed INSTEC(INformation System of Trip Event Cases) which can manage data obtained as the result of incident analysis. The analysis procedure is consisted of the following steps; reconfiguration of incident context, identification of the paths and contents of the interaction between plant components, identification of unit event obstructing normal plant operation, identification of possible erroneous actions, decision of error modes, identification of likely causes, summarization of analysis results. INSTEC was developed to effectively present the result of incident analysis. This system offers the analyzed information such as analysis results of human error cases, operating issues and problems, recommendations to prevent a similar incident, etc. 24 tabs., 18 figs., 10 refs. (Author)

  11. Address-event-based platform for bioinspired spiking systems

    Science.gov (United States)

    Jiménez-Fernández, A.; Luján, C. D.; Linares-Barranco, A.; Gómez-Rodríguez, F.; Rivas, M.; Jiménez, G.; Civit, A.

    2007-05-01

    Address Event Representation (AER) is an emergent neuromorphic interchip communication protocol that allows a real-time virtual massive connectivity between huge number neurons, located on different chips. By exploiting high speed digital communication circuits (with nano-seconds timings), synaptic neural connections can be time multiplexed, while neural activity signals (with mili-seconds timings) are sampled at low frequencies. Also, neurons generate "events" according to their activity levels. More active neurons generate more events per unit time, and access the interchip communication channel more frequently, while neurons with low activity consume less communication bandwidth. When building multi-chip muti-layered AER systems, it is absolutely necessary to have a computer interface that allows (a) reading AER interchip traffic into the computer and visualizing it on the screen, and (b) converting conventional frame-based video stream in the computer into AER and injecting it at some point of the AER structure. This is necessary for test and debugging of complex AER systems. In the other hand, the use of a commercial personal computer implies to depend on software tools and operating systems that can make the system slower and un-robust. This paper addresses the problem of communicating several AER based chips to compose a powerful processing system. The problem was discussed in the Neuromorphic Engineering Workshop of 2006. The platform is based basically on an embedded computer, a powerful FPGA and serial links, to make the system faster and be stand alone (independent from a PC). A new platform is presented that allow to connect up to eight AER based chips to a Spartan 3 4000 FPGA. The FPGA is responsible of the network communication based in Address-Event and, at the same time, to map and transform the address space of the traffic to implement a pre-processing. A MMU microprocessor (Intel XScale 400MHz Gumstix Connex computer) is also connected to the FPGA

  12. Duke Surgery Patient Safety: an open-source application for anonymous reporting of adverse and near-miss surgical events.

    Science.gov (United States)

    Pietrobon, Ricardo; Lima, Raquel; Shah, Anand; Jacobs, Danny O; Harker, Matthew; McCready, Mariana; Martins, Henrique; Richardson, William

    2007-05-01

    Studies have shown that 4% of hospitalized patients suffer from an adverse event caused by the medical treatment administered. Some institutions have created systems to encourage medical workers to report these adverse events. However, these systems often prove to be inadequate and/or ineffective for reviewing the data collected and improving the outcomes in patient safety. To describe the Web-application Duke Surgery Patient Safety, designed for the anonymous reporting of adverse and near-miss events as well as scheduled reporting to surgeons and hospital administration. SOFTWARE ARCHITECTURE: DSPS was developed primarily using Java language running on a Tomcat server and with MySQL database as its backend. Formal and field usability tests were used to aid in development of DSPS. Extensive experience with DSPS at our institution indicate that DSPS is easy to learn and use, has good speed, provides needed functionality, and is well received by both adverse-event reporters and administrators. This is the first description of an open-source application for reporting patient safety, which allows the distribution of the application to other institutions in addition for its ability to adapt to the needs of different departments. DSPS provides a mechanism for anonymous reporting of adverse events and helps to administer Patient Safety initiatives. The modifiable framework of DSPS allows adherence to evolving national data standards. The open-source design of DSPS permits surgical departments with existing reporting mechanisms to integrate them with DSPS. The DSPS application is distributed under the GNU General Public License.

  13. Complexity of deciding detectability in discrete event systems

    Czech Academy of Sciences Publication Activity Database

    Masopust, Tomáš

    2018-01-01

    Roč. 93, July (2018), s. 257-261 ISSN 0005-1098 Institutional support: RVO:67985840 Keywords : discrete event systems * finite automata * detectability Subject RIV: BA - General Mathematics OBOR OECD: Computer science s, information science , bioinformathics (hardware development to be 2.2, social aspect to be 5.8) Impact factor: 5.451, year: 2016 https://www. science direct.com/ science /article/pii/S0005109818301730

  14. NiMax system for hadronic event generators in HEP

    International Nuclear Information System (INIS)

    Amelin, N.S.; Komogorov, M.E.

    2001-01-01

    We have suggested a new approach to the development and use of Monte Carlo event generators in high-energy physics (HEP). It is a component approach, when a complex numerical model is composed of standard components. Our approach opens a way to organize a library of HEP model components and provides a great flexibility for the construction of very powerful and realistic numerical models. To support this approach we have designed the NiMax software system (framework) written in C++

  15. Complexity of deciding detectability in discrete event systems

    Czech Academy of Sciences Publication Activity Database

    Masopust, Tomáš

    2018-01-01

    Roč. 93, July (2018), s. 257-261 ISSN 0005-1098 Institutional support: RVO:67985840 Keywords : discrete event systems * finite automata * detectability Subject RIV: BA - General Mathematics OBOR OECD: Computer sciences, information science, bioinformathics (hardware development to be 2.2, social aspect to be 5.8) Impact factor: 5.451, year: 2016 https://www.sciencedirect.com/science/article/pii/S0005109818301730

  16. The aviation safety reporting system

    Science.gov (United States)

    Reynard, W. D.

    1984-01-01

    The aviation safety reporting system, an accident reporting system, is presented. The system identifies deficiencies and discrepancies and the data it provides are used for long term identification of problems. Data for planning and policy making are provided. The system offers training in safety education to pilots. Data and information are drawn from the available data bases.

  17. Discrete-event simulation of nuclear-waste transport in geologic sites subject to disruptive events. Final report

    International Nuclear Information System (INIS)

    Aggarwal, S.; Ryland, S.; Peck, R.

    1980-01-01

    This report outlines a methodology to study the effects of disruptive events on nuclear waste material in stable geologic sites. The methodology is based upon developing a discrete events model that can be simulated on the computer. This methodology allows a natural development of simulation models that use computer resources in an efficient manner. Accurate modeling in this area depends in large part upon accurate modeling of ion transport behavior in the storage media. Unfortunately, developments in this area are not at a stage where there is any consensus on proper models for such transport. Consequently, our work is directed primarily towards showing how disruptive events can be properly incorporated in such a model, rather than as a predictive tool at this stage. When and if proper geologic parameters can be determined, then it would be possible to use this as a predictive model. Assumptions and their bases are discussed, and the mathematical and computer model are described

  18. Seismic design margin evaluation of systems and equipment required for safe shutdown of North Anna, Units 1 and 2, following an SSE (safe-shutdown earthquake) event. Technical report

    International Nuclear Information System (INIS)

    Desai, K.D.

    1981-06-01

    The Advisory Committee on Reactor Safeguards recommended that the NRC staff review in detail the capability and available seismic design margin of fluid systems and equipment used in North Anna, Units 1 and 2 to achieve safe shutdown following a site-design safe-shutdown earthquake (SSE). The staff conducted a series of plant visits and meetings with the licensee to view and discuss the seismic design methodology used for systems, equipment and their supports. The report is a description and evaluation of the seismic design criteria, design conservatisms and seismic design margin for North Anna, Units 1 and 2

  19. Prism reactor system design and analysis of postulated unscrammed events

    International Nuclear Information System (INIS)

    Van Tuyle, G.J.; Slovik, G.C.

    1991-08-01

    Key safety characteristics of the PRISM reactor system include the passive reactor shutdown characteristic and the passive shutdown heat removal system, RVACS. While these characteristics are simple in principle, the physical processes are fairly complex, particularly for the passive reactor shutdown. It has been possible to adapt independent safety analysis codes originally developed for the Clinch River Breeder Reactor review, although some limitations remain. In this paper, the analyses of postulated unscrammed events are discussed, along with limitations in the predictive capabilities and plans to correct the limitations in the near future. 6 refs., 4 figs

  20. PRISM reactor system design and analysis of postulated unscrammed events

    International Nuclear Information System (INIS)

    Van Tuyle, G.J.; Slovik, G.C.

    1991-01-01

    Key safety characteristics of the PRISM reactor system include the passive reactor shutdown characteristic and the passive shutdown heat removal system, RVACS. While these characteristics are simple in principle, the physical processes are fairly complex, particularly for the passive reactor shutdown. It has been possible to adapt independent safety analysis codes originally developed for the Clinch River Breeder Reactor review, although some limitations remain. In this paper, the analyses of postulated unscrammed events are discussed, along with limitations in the predictive capabilities and plans to correct the limitations in the near future. (author)

  1. PRISM reactor system design and analysis of postulated unscrammed events

    International Nuclear Information System (INIS)

    Van Tuyle, G.J.; Slovik, G.C.; Rosztoczy, Z.; Lane, J.

    1991-01-01

    Key safety characteristics of the PRISM reactor system include the passive reactor shutdown characteristics and the passive shutdown heat removal system, RVACS. While these characteristics are simple in principle, the physical processes are fairly complex, particularly for the passive reactor shutdown. It has been possible to adapt independent safety analysis codes originally developed for the Clinch River Breeder Reactor review, although some limitations remain. In this paper, the analyses of postulated unscrammed events are discussed, along with limitations in the predictive capabilities and plans to correct the limitations in the near future. 6 refs., 4 figs

  2. Power System Extreme Event Detection: The VulnerabilityFrontier

    Energy Technology Data Exchange (ETDEWEB)

    Lesieutre, Bernard C.; Pinar, Ali; Roy, Sandip

    2007-10-17

    In this work we apply graph theoretic tools to provide aclose bound on a frontier relating the number of line outages in a gridto the power disrupted by the outages. This frontier describes theboundary of a space relating the possible severity of a disturbance interms of power disruption, from zero to some maximum on the boundary, tothe number line outages involved in the event. We present the usefulnessof this analysis with a complete analysis of a 30 bus system, and presentresults for larger systems.

  3. Dansgaard–Oeschger events: bifurcation points in the climate system

    Directory of Open Access Journals (Sweden)

    A. A. Cimatoribus

    2013-02-01

    Full Text Available Dansgaard–Oeschger events are a prominent mode of variability in the records of the last glacial cycle. Various prototype models have been proposed to explain these rapid climate fluctuations, and no agreement has emerged on which may be the more correct for describing the palaeoclimatic signal. In this work, we assess the bimodality of the system, reconstructing the topology of the multi-dimensional attractor over which the climate system evolves. We use high-resolution ice core isotope data to investigate the statistical properties of the climate fluctuations in the period before the onset of the abrupt change. We show that Dansgaard–Oeschger events have weak early warning signals if the ensemble of events is considered. We find that the statistics are consistent with the switches between two different climate equilibrium states in response to a changing external forcing (e.g. solar, ice sheets, either forcing directly the transition or pacing it through stochastic resonance. These findings are most consistent with a model that associates Dansgaard–Oeschger with changing boundary conditions, and with the presence of a bifurcation point.

  4. Estimating rare events in biochemical systems using conditional sampling

    Science.gov (United States)

    Sundar, V. S.

    2017-01-01

    The paper focuses on development of variance reduction strategies to estimate rare events in biochemical systems. Obtaining this probability using brute force Monte Carlo simulations in conjunction with the stochastic simulation algorithm (Gillespie's method) is computationally prohibitive. To circumvent this, important sampling tools such as the weighted stochastic simulation algorithm and the doubly weighted stochastic simulation algorithm have been proposed. However, these strategies require an additional step of determining the important region to sample from, which is not straightforward for most of the problems. In this paper, we apply the subset simulation method, developed as a variance reduction tool in the context of structural engineering, to the problem of rare event estimation in biochemical systems. The main idea is that the rare event probability is expressed as a product of more frequent conditional probabilities. These conditional probabilities are estimated with high accuracy using Monte Carlo simulations, specifically the Markov chain Monte Carlo method with the modified Metropolis-Hastings algorithm. Generating sample realizations of the state vector using the stochastic simulation algorithm is viewed as mapping the discrete-state continuous-time random process to the standard normal random variable vector. This viewpoint opens up the possibility of applying more sophisticated and efficient sampling schemes developed elsewhere to problems in stochastic chemical kinetics. The results obtained using the subset simulation method are compared with existing variance reduction strategies for a few benchmark problems, and a satisfactory improvement in computational time is demonstrated.

  5. 76 FR 1170 - Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and...

    Science.gov (United States)

    2011-01-07

    ... appropriate FDA organizational unit responsible for adverse event reporting compliance when these conditions... regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking... appropriate FDA organizational unit responsible for adverse event reporting compliance when the conditions...

  6. Guidelines for submitting adverse event reports for publication

    NARCIS (Netherlands)

    Kelly, William; Arellano, Felix; Barnes, Joanne; Bergman, Ulf; Edwards, Ralph; Fernandez, Alina; Freedman, Stephen; Goldsmith, David; Huang, Kui; Jones, Judith; McLeay, Rachel; Moore, Nicholas; Stather, Rosie; Trenque, Thierry; Troutman, William; van Puijenbroek, Eugène; Williams, Frank; Wise, Robert

    2009-01-01

    Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these

  7. Corporate Disclosure, Materiality, and Integrated Report: An Event Study Analysis

    OpenAIRE

    Maria Cleofe Giorgino; Enrico Supino; Federico Barnabè

    2017-01-01

    Within the extensive literature investigating the impacts of corporate disclosure in supporting the sustainable growth of an organization, few studies have included in the analysis the materiality issue referred to the information being disclosed. This article aims to address this gap, exploring the effect produced on capital markets by the publication of a recent corporate reporting tool, Integrated Report (IR). The features of this tool are that it aims to represent the multidimensional imp...

  8. Sampling rare events in nonequilibrium and nonstationary systems.

    Science.gov (United States)

    Berryman, Joshua T; Schilling, Tanja

    2010-12-28

    Although many computational methods for rare event sampling exist, this type of calculation is not usually practical for general nonequilibrium conditions, with macroscopically irreversible dynamics and away from both stationary and metastable states. A novel method for calculating the time-series of the probability of a rare event is presented which is designed for these conditions. The method is validated for the cases of the Glauber-Ising model under time-varying shear flow, the Kawasaki-Ising model after a quench into the region between nucleation dominated and spinodal decomposition dominated phase change dynamics, and the parallel open asymmetric exclusion process. The method requires a subdivision of the phase space of the system: it is benchmarked and found to scale well for increasingly fine subdivisions, meaning that it can be applied without detailed foreknowledge of the physically important reaction pathways.

  9. Earthquake-associated events. Annual safety research report, JFY 2011

    International Nuclear Information System (INIS)

    2012-01-01

    For the tsunami and slope stability as the earthquake-associated events that increased with the revision of the regulatory guide for reviewing seismic design of nuclear power reactor facilities, related technical standard and analysis code were leveled up to support the safety examination of the country. For tsunami study, the original plan was changed due to the 2011 Tohoku earthquake tsunami, analysis code of river run-up, sedimentation, probabilistic tsunami hazard and tsunami trace database were developed. For slope study, in addition to conventional stress criteria, in order to build a slope stability evaluation method, incorporating new indicators, such as deformation and strain, the following study was conducted. The large-scale shaking table test for E-defense, the test data were obtained. The applicability of slope stability analysis code was examined by using the shaking table test data. (author)

  10. 17th East European Conference on Advances in Databases and Information Systems and Associated Satellite Events

    CERN Document Server

    Cerquitelli, Tania; Chiusano, Silvia; Guerrini, Giovanna; Kämpf, Mirko; Kemper, Alfons; Novikov, Boris; Palpanas, Themis; Pokorný, Jaroslav; Vakali, Athena

    2014-01-01

    This book reports on state-of-art research and applications in the field of databases and information systems. It includes both fourteen selected short contributions, presented at the East-European Conference on Advances in Databases and Information Systems (ADBIS 2013, September 1-4, Genova, Italy), and twenty-six papers from ADBIS 2013 satellite events. The short contributions from the main conference are collected in the first part of the book, which covers a wide range of topics, like data management, similarity searches, spatio-temporal and social network data, data mining, data warehousing, and data management on novel architectures, such as graphics processing units, parallel database management systems, cloud and MapReduce environments. In contrast, the contributions from the satellite events are organized in five different parts, according to their respective ADBIS satellite event: BiDaTA 2013 - Special Session on Big Data: New Trends and Applications); GID 2013 – The Second International Workshop ...

  11. Examining Wrong Eye Implant Adverse Events in the Veterans Health Administration With a Focus on Prevention: A Preliminary Report.

    Science.gov (United States)

    Neily, Julia; Chomsky, Amy; Orcutt, James; Paull, Douglas E; Mills, Peter D; Gilbert, Christina; Hemphill, Robin R; Gunnar, William

    2018-03-01

    The study goals were to examine wrong intraocular lens (IOL) implant adverse events in the Veterans Health Administration (VHA), identify root causes and contributing factors, and describe system changes that have been implemented to address this challenge. This study represents collaboration between the VHA's National Center for Patient Safety (NCPS) and the National Surgery Office (NSO). This report includes 45 wrong IOL implant surgery adverse events reported to established VHA NCPS and NSO databases between July 1, 2006, and June 31, 2014. There are approximately 50,000 eye implant procedures performed each year in the VHA. Wrong IOL implant surgery adverse events are reported by VHA facilities to the NCPS and the NSO. Two authors (A.C. and J.N.) coded the reports for event type (wrong lens or expired lens) and identified the primary contributing factor (coefficient κ = 0.837). A descriptive analysis was conducted, which included the reported yearly event rate. The main outcome measure was the reported wrong IOL implant surgery adverse events. There were 45 reported wrong IOL implant surgery adverse events. Between 2011 and June 30, 2014, there was a significant downward trend (P = 0.02, R = 99.7%) at a pace of -0.08 (per 10,000 cases) every year. The most frequently coded primary contributing factor was incomplete preprocedure time-out (n = 12) followed by failure to perform double check of preprocedural calculations based upon original data and implant read-back at the time the surgical eye implant was performed (n = 10). Preventing wrong IOL implant adverse events requires diligence beyond performance of the preprocedural time-out. In 2013, the VHA has modified policy to ensure double check of preprocedural calculations and implant read-back with positive impact. Continued analysis of contributing human factors and improved surgical team communication are warranted.

  12. Computer-based systems important to safety (COMPSIS) - Reporting guidelines

    International Nuclear Information System (INIS)

    1999-07-01

    The objective of this procedure is to help the user to prepare an COMPSIS report on an event so that important lessons learned are most efficiently transferred to the database. This procedure focuses on the content of the information to be provided in the report rather than on its format. The established procedure follows to large extend the procedure chosen by the IRS incident reporting system. However this database is built for I and C equipment with the purpose of the event report database to collect and disseminate information on events of significance involving Computer-Based Systems important to safety in nuclear power plants, and feedback conclusions and lessons learnt from such events. For events where human performance is dominant to draw lessons, more detailed guidance on the specific information that should be supplied is spelled out in the present procedure. This guidance differs somewhat from that for the provision of technical information, and takes into account that the engineering world is usually less familiar with human behavioural analysis than with technical analysis. The events to be reported to the COMPSIS database should be based on the national reporting criteria in the participating member countries. The aim is that all reports including computer based systems that meet each country reporting criteria should be reported. The database should give a broad picture of events/incidents occurring in operation with computer control systems. As soon as an event has been identified, the insights and lessons learnt to be conveyed to the international nuclear community shall be clearly identified. On the basis of the description of the event, the event shall be analyzed in detail under the aspect of direct and potential impact to plant safety functions. The first part should show the common involvement of operation and safety systems and the second part should show the special aspects of I and C functions, hardware and software

  13. A study for the sequence of events (SOE) system on the nuclear power plant

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Byung Chae; Jeon, Jong Sun; Lee, Sun Sung; Lee, Kyung Ho; Lee, Byung Ju; Sohn, Kwang Young [Korea Atomic Energy Research Institute, Taejon (Korea, Republic of)

    1996-06-01

    It is important to identify where and why an event or a trip is occurred in the Nuclear Power Plant(NPP) and to provide proper resolution against above situation. In order to analyze the prime cause or conspicuous reason of trouble occurred after events or trips occur, the Sequence of Events(SOE) system has been adopted in Korean NPP to acquire the sequential information along where and when an event or a trip take place. The SOE system of UCN 3 and 4 plant which is included in the Plant Data Acquisition System (PDAS), shares the 3205 computer and system software with PDAS. Sharing of the computer H/w and S/W, however, requires more complicated process to provide the events or trip signals due to the inherent characteristics of the shared system. Moreover there are high potentiality of collision between synchronization signals and data transmitted to the Plant Computer System (PCS), when the synchronization signals are sent from PCS to the three SOE processors. When this collision happens the SOE system will break down, thus it is not possible to analyze the trend of events or trips. An independent SOE system composed with single processor is proposed in this paper. To begin with, the analyses on the hardware and software of SOE and PDAS system of UCN 3 and 4 were performed to justify the problems and the resolution if it exists. In order to test the new SOE system, VMEbus, VM30 CPU, change of status I/O card and OS-9 for the operating system were adopted and the analysis for this test system was done as follows; the verification should be achieved through the simulation; the simulated signals for events are given the test system as inputs and the outputs are monitored to verify whether the sequential events logging function works well or not on PC. In conclusion, this report is expected to provide the technical background for the improvement and changing of the NPP PDAS and SOE system in the future. 18 tabs., 33 figs., 26 refs. (Author) .new.

  14. A study for the sequence of events (SOE) system on the nuclear power plant

    International Nuclear Information System (INIS)

    Lee, Byung Chae; Jeon, Jong Sun; Lee, Sun Sung; Lee, Kyung Ho; Lee, Byung Ju; Sohn, Kwang Young

    1996-06-01

    It is important to identify where and why an event or a trip is occurred in the Nuclear Power Plant(NPP) and to provide proper resolution against above situation. In order to analyze the prime cause or conspicuous reason of trouble occurred after events or trips occur, the Sequence of Events(SOE) system has been adopted in Korean NPP to acquire the sequential information along where and when an event or a trip take place. The SOE system of UCN 3 and 4 plant which is included in the Plant Data Acquisition System (PDAS), shares the 3205 computer and system software with PDAS. Sharing of the computer H/w and S/W, however, requires more complicated process to provide the events or trip signals due to the inherent characteristics of the shared system. Moreover there are high potentiality of collision between synchronization signals and data transmitted to the Plant Computer System (PCS), when the synchronization signals are sent from PCS to the three SOE processors. When this collision happens the SOE system will break down, thus it is not possible to analyze the trend of events or trips. An independent SOE system composed with single processor is proposed in this paper. To begin with, the analyses on the hardware and software of SOE and PDAS system of UCN 3 and 4 were performed to justify the problems and the resolution if it exists. In order to test the new SOE system, VMEbus, VM30 CPU, change of status I/O card and OS-9 for the operating system were adopted and the analysis for this test system was done as follows; the verification should be achieved through the simulation; the simulated signals for events are given the test system as inputs and the outputs are monitored to verify whether the sequential events logging function works well or not on PC. In conclusion, this report is expected to provide the technical background for the improvement and changing of the NPP PDAS and SOE system in the future. 18 tabs., 33 figs., 26 refs. (Author) .new

  15. Congestion Management System Process Report

    Science.gov (United States)

    1996-03-01

    In January 1995, the Indianapolis Metropolitan Planning Organization with the help of an interagency Study Review Committee began the process of developing a Congestion Management System (CMS) Plan resulting in this report. This report documents the ...

  16. 78 FR 20039 - Reportable Events and Certain Other Notification Requirements

    Science.gov (United States)

    2013-04-03

    ... for other purposes. Impact of Proposal Overall, PBGC expects the proposal to exempt or waive more than... some of those terminations might have been avoided, and PBGC might have been able to reduce the impact... accounting principles (GAAP) or International Financial Reporting Standards (IFRS). This requirement serves...

  17. Active versus passive adverse event reporting after pediatric chiropractic manual therapy: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Pohlman, Katherine A; Carroll, Linda; Tsuyuki, Ross T; Hartling, Lisa; Vohra, Sunita

    2017-12-01

    Patient safety performance can be assessed with several systems, including passive and active surveillance. Passive surveillance systems provide opportunity for health care personnel to confidentially and voluntarily report incidents, including adverse events, occurring in their work environment. Active surveillance systems systematically monitor patient encounters to seek detailed information about adverse events that occur in work environments; unlike passive surveillance, active surveillance allows for collection of both numerator (number of adverse events) and denominator (number of patients seen) data. Chiropractic manual therapy is commonly used in both adults and children, yet few studies have been done to evaluate the safety of chiropractic manual therapy for children. In an attempt to evaluate this, this study will compare adverse event reporting in passive versus active surveillance systems after chiropractic manual therapy in the pediatric population. This cluster randomized controlled trial aims to enroll 70 physicians of chiropractic (unit of randomization) to either passive or active surveillance system to report adverse events that occur after treatment for 60 consecutive pediatric (13 years of age and younger) patient visits (unit of analysis). A modified enrollment process with a two-phase consent procedure will be implemented to maintain provider blinding and minimize dropouts. The first phase of consent is for the provider to confirm their interest in a trial investigating the safety of chiropractic manual therapy. The second phase ensures that they understand the specific requirements for the group to which they were randomized. Percentages, incidence estimates, and 95% confidence intervals will be used to describe the count of reported adverse events in each group. The primary outcome will be the number and quality of the adverse event reports in the active versus the passive surveillance group. With 80% power and 5% one-sided significance

  18. Risk evaluation system for operational events and inspection findings

    International Nuclear Information System (INIS)

    Lopez G, A.; Godinez S, V.; Lopez M, R.

    2010-10-01

    The Mexican Nuclear Regulatory Commission has developed an adaptation of the US NRC Significance Determination Process (SDP) to evaluate the risk significance of operational events and inspection findings in Laguna Verde nuclear power plant. The Mexican Nuclear Regulatory Commission developed a plant specific flow chart for preliminary screening instead of the open questionnaire used by the US NRC-SDP, with the aim to improve the accuracy of the screening process. Also, the work sheets and support information tables required by the SDP were built up in an Excel application which allows to perform the risk evaluation in an automatic way, focusing the regulator staff efforts in the risk significance analysis instead of the risk calculation tasks. In order to construct this tool a simplified PRA model was developed and validated with the individual plant examination model. This paper shows the Mexican Nuclear Regulatory Commission process and some risk events evaluations performed using the Risk Evaluation System for Operational Events and Inspection Findings (SERHE, by its acronyms in Spanish). (Author)

  19. Solar proton events and their effect on space systems

    International Nuclear Information System (INIS)

    Tranquille, C.

    1994-01-01

    Solar protons present a major problem to space systems because of the ionisation and displacement effects which arise from their interaction with matter. This is likely to become a greater problem in the future due to the use of more sensitive electronic components and the proposed expansion of manned activities in space. An outline is provided of the physical processes associated with individual solar events, the solar activity cycle and the transport of solar particles between the Sun and the Earth. The problems of predicting solar event fluences, both over short- and long-term periods, are discussed. The currently available solar proton event models used for long-term forecasting are briefly reviewed, and the advantages and deficiencies of each model are investigated. Predictions using the models are compared to measurements made by the GOES-7 satellite during the rising phase of the current solar cycle. These measurements are also used to illustrate the sensitivity of the models to the choice of confidence level and to the spectral form used for extrapolation over the solar proton energy range. (author)

  20. Using Gagne’s nine events in learning management systems

    Directory of Open Access Journals (Sweden)

    Ali Gokdemir

    2015-01-01

    Full Text Available Distance education has been widely used in education. Many learning management systems (LMSs have been developed for the distance education. The use of LMSs in distance education has several benefits; however, LMSs do not maintain any elements to guide educators to design and develop instruction. The purpose of this study is to design, develop and evaluate an LMS that guides facilitators when designing instructional modules for their online courses based on Gagne’s nine events. The new LMS was developed and evaluated using the revised version of the “Waterfall Model”. The study population consists of the system administrators, course facilitators, and online students. The users of the system found the developed LMS useful. The facilitator and online students easily fulfilled the tasks specified in the developed LMS.

  1. SENTINEL EVENTS

    Directory of Open Access Journals (Sweden)

    Andrej Robida

    2004-09-01

    Full Text Available Background. The Objective of the article is a two year statistics on sentinel events in hospitals. Results of a survey on sentinel events and the attitude of hospital leaders and staff are also included. Some recommendations regarding patient safety and the handling of sentinel events are given.Methods. In March 2002 the Ministry of Health introduce a voluntary reporting system on sentinel events in Slovenian hospitals. Sentinel events were analyzed according to the place the event, its content, and root causes. To show results of the first year, a conference for hospital directors and medical directors was organized. A survey was conducted among the participants with the purpose of gathering information about their view on sentinel events. One hundred questionnaires were distributed.Results. Sentinel events. There were 14 reports of sentinel events in the first year and 7 in the second. In 4 cases reports were received only after written reminders were sent to the responsible persons, in one case no reports were obtained. There were 14 deaths, 5 of these were in-hospital suicides, 6 were due to an adverse event, 3 were unexplained. Events not leading to death were a suicide attempt, a wrong side surgery, a paraplegia after spinal anaesthesia, a fall with a femoral neck fracture, a damage of the spleen in the event of pleural space drainage, inadvertent embolization with absolute alcohol into a femoral artery and a physical attack on a physician by a patient. Analysis of root causes of sentinel events showed that in most cases processes were inadequate.Survey. One quarter of those surveyed did not know about the sentinel events reporting system. 16% were having actual problems when reporting events and 47% beleived that there was an attempt to blame individuals. Obstacles in reporting events openly were fear of consequences, moral shame, fear of public disclosure of names of participants in the event and exposure in mass media. The majority of

  2. Bridging data models and terminologies to support adverse drug event reporting using EHR data.

    Science.gov (United States)

    Declerck, G; Hussain, S; Daniel, C; Yuksel, M; Laleci, G B; Twagirumukiza, M; Jaulent, M-C

    2015-01-01

    This article is part of the Focus Theme of METHODs of Information in Medicine on "Managing Interoperability and Complexity in Health Systems". SALUS project aims at building an interoperability platform and a dedicated toolkit to enable secondary use of electronic health records (EHR) data for post marketing drug surveillance. An important component of this toolkit is a drug-related adverse events (AE) reporting system designed to facilitate and accelerate the reporting process using automatic prepopulation mechanisms. To demonstrate SALUS approach for establishing syntactic and semantic interoperability for AE reporting. Standard (e.g. HL7 CDA-CCD) and proprietary EHR data models are mapped to the E2B(R2) data model via SALUS Common Information Model. Terminology mapping and terminology reasoning services are designed to ensure the automatic conversion of source EHR terminologies (e.g. ICD-9-CM, ICD-10, LOINC or SNOMED-CT) to the target terminology MedDRA which is expected in AE reporting forms. A validated set of terminology mappings is used to ensure the reliability of the reasoning mechanisms. The percentage of data elements of a standard E2B report that can be completed automatically has been estimated for two pilot sites. In the best scenario (i.e. the available fields in the EHR have actually been filled), only 36% (pilot site 1) and 38% (pilot site 2) of E2B data elements remain to be filled manually. In addition, most of these data elements shall not be filled in each report. SALUS platform's interoperability solutions enable partial automation of the AE reporting process, which could contribute to improve current spontaneous reporting practices and reduce under-reporting, which is currently one major obstacle in the process of acquisition of pharmacovigilance data.

  3. Human visual system automatically encodes sequential regularities of discrete events.

    Science.gov (United States)

    Kimura, Motohiro; Schröger, Erich; Czigler, István; Ohira, Hideki

    2010-06-01

    For our adaptive behavior in a dynamically changing environment, an essential task of the brain is to automatically encode sequential regularities inherent in the environment into a memory representation. Recent studies in neuroscience have suggested that sequential regularities embedded in discrete sensory events are automatically encoded into a memory representation at the level of the sensory system. This notion is largely supported by evidence from investigations using auditory mismatch negativity (auditory MMN), an event-related brain potential (ERP) correlate of an automatic memory-mismatch process in the auditory sensory system. However, it is still largely unclear whether or not this notion can be generalized to other sensory modalities. The purpose of the present study was to investigate the contribution of the visual sensory system to the automatic encoding of sequential regularities using visual mismatch negativity (visual MMN), an ERP correlate of an automatic memory-mismatch process in the visual sensory system. To this end, we conducted a sequential analysis of visual MMN in an oddball sequence consisting of infrequent deviant and frequent standard stimuli, and tested whether the underlying memory representation of visual MMN generation contains only a sensory memory trace of standard stimuli (trace-mismatch hypothesis) or whether it also contains sequential regularities extracted from the repetitive standard sequence (regularity-violation hypothesis). The results showed that visual MMN was elicited by first deviant (deviant stimuli following at least one standard stimulus), second deviant (deviant stimuli immediately following first deviant), and first standard (standard stimuli immediately following first deviant), but not by second standard (standard stimuli immediately following first standard). These results are consistent with the regularity-violation hypothesis, suggesting that the visual sensory system automatically encodes sequential

  4. Control of discrete event systems modeled as hierarchical state machines

    Science.gov (United States)

    Brave, Y.; Heymann, M.

    1991-01-01

    The authors examine a class of discrete event systems (DESs) modeled as asynchronous hierarchical state machines (AHSMs). For this class of DESs, they provide an efficient method for testing reachability, which is an essential step in many control synthesis procedures. This method utilizes the asynchronous nature and hierarchical structure of AHSMs, thereby illustrating the advantage of the AHSM representation as compared with its equivalent (flat) state machine representation. An application of the method is presented where an online minimally restrictive solution is proposed for the problem of maintaining a controlled AHSM within prescribed legal bounds.

  5. The preparation of reports of a significant event at a uranium processing or uranium handling facility

    International Nuclear Information System (INIS)

    1988-08-01

    Licenses to operate uranium processing or uranium handling facilities require that certain events be reported to the Atomic Energy Control Board (AECB) and to other regulatory authorities. Reports of a significant event describe unusual events which had or could have had a significant impact on the safety of facility operations, the worker, the public or on the environment. The purpose of this guide is to suggest an acceptable method of reporting a significant event to the AECB and to describe the information that should be included. The reports of a significant event are made available to the public in accordance with the provisions of the Access to Information Act and the AECB's policy on public access to licensing information

  6. Contractor Performance Assessment Reporting System

    Data.gov (United States)

    US Agency for International Development — CPARS is a web-based system used to input data on contractor performance. Reports from the system are used as an aid in awarding contracts to contractors that...

  7. Online surveillance of media health event reporting in Nepal: digital disease detection from a One Health perspective.

    Science.gov (United States)

    Schwind, Jessica S; Norman, Stephanie A; Karmacharya, Dibesh; Wolking, David J; Dixit, Sameer M; Rajbhandari, Rajesh M; Mekaru, Sumiko R; Brownstein, John S

    2017-09-21

    Traditional media and the internet are crucial sources of health information. Media can significantly shape public opinion, knowledge and understanding of emerging and endemic health threats. As digital communication rapidly progresses, local access and dissemination of health information contribute significantly to global disease detection and reporting. Health event reports in Nepal (October 2013-December 2014) were used to characterize Nepal's media environment from a One Health perspective using HealthMap - a global online disease surveillance and mapping tool. Event variables (location, media source type, disease or risk factor of interest, and affected species) were extracted from HealthMap. A total of 179 health reports were captured from various sources including newspapers, inter-government agency bulletins, individual reports, and trade websites, yielding 108 (60%) unique articles. Human health events were reported most often (n = 85; 79%), followed by animal health events (n = 23; 21%), with no reports focused solely on environmental health. By expanding event coverage across all of the health sectors, media in developing countries could play a crucial role in national risk communication efforts and could enhance early warning systems for disasters and disease outbreaks.

  8. Interfacing system isolation experience review. Final report, August 1991

    International Nuclear Information System (INIS)

    1991-08-01

    A light water reactor power plant has auxiliary systems interconnected with the reactor coolant system that are not designed for reactor operating pressure. These principally include the shutdown heat removal systems and various emergency core cooling injection systems. There are multiple isolation valves that prevent rector vessel pressure from causing overpressurization in low pressure interfacing systems. Combinations of hardware failures or operational errors are necessary to expose these systems to overpressurization. This experience review provides insights regarding the risk that an auxiliary system might become over pressurized from the reactor system. While analyses show that for the pressures involved the probability of auxiliary system failure is low, the auxiliary system conceivably might fail outside of containment while the plant is at power. Such a potential event has come to be called an interfacing system loss of coolant accident (ISLOCA). This report provides a compilation of occurrences where valve leakage, valve failure, or valve mispositioning played a role in the ability to maintain interfacing system isolation. Seventeen U.S. BWR events, twenty three U.S. PWR events and one foreign event are discussed in the report. Eleven of the U.S. BWR events and ten U.S. PWR events are judged to relate directly to the so-called ISLOCA event in that they fulfilled one or more of the failures necessary to cause an ISLOCA. (author)

  9. Australian regulatory framework and reporting entities are hindering the lessons to be learned from adverse radiation events

    International Nuclear Information System (INIS)

    Denham, G.

    2016-01-01

    When adverse radiation events occur in the medical radiation science profession in Australia they are reported to the relevant state or territory authority. The details and cause of the incident are forwarded to the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) to be included in the Australian Radiation Incident Register. The aim of any error reporting system is to learn from previous errors and to prevent them occurring again. The information obtained from past errors is one of the most invaluable tools to prevent future adverse events. This article examines the current regulatory framework, reporting systems and radiation protection authorities in Australia and their effectiveness at improving patient safety. Several obstacles must be overcome if the systems and organisations responsible for radiation safety are to meet the expectations of both the community and the medical radiation science profession. - Highlights: • Adverse radiation events in Australia are reported to state and territory authorities. • Adverse radiation events are included in the Australian Radiation Incident Register State and territory radiation authorities have failed to implement changes agreed upon in 1999. • The Australian Radiation Incident Register requires reforms if it is to operate as an effective learning system.

  10. Atlanta Centennial Olympic Games and Paralympic Games event study, 1996. Final report, July 1996--August 1996

    Energy Technology Data Exchange (ETDEWEB)

    Amodei, R.; Bard, E.; Brong, B.; Cahoon, F.; Jasper, K.

    1998-11-01

    The Atlanta metropolitan region was the location of one of the most ambitious Intelligent Transportation Systems (ITS) deployments in the United States. This deployment included several individual projects--a Central Transportation Management Center (TMC), six Traffic Control Centers (TCCs), one Transit Information Center (TIC), The Travel Information Showcase (TIS), and the extension of the Metropolitan Atlanta Rapid Transit Authority (MARTA) Rail network and the new high-occupancy vehicle (HOV) lanes on I-85 and I-75. The 1996 Atlanta Centennial Olympic Games and Paralympic Games created a focus for these projects. All of these systems were to be brought on-line in time for the Olympic Games. This report presents the findings of the 1996 Olympic and Paralympic Games Events Study--a compilation of findings of system performance, the benefits realized, and the lessons learned during their operations over the event period. The study assessed the performance of the various Travel Demand Management (TDM) plans employed for Olympic Games traffic management.

  11. Report of Animal Investigation Program activities for the Baneberry Event

    International Nuclear Information System (INIS)

    Smith, D.D.; Black, S.C.; Giles, K.R.; Moghissi, A.A.

    1975-11-01

    On December 18, 1970, an underground nuclear test, conducted at the Nevada Test Site, released radioactive materials into the atmosphere with resultant on-site and off-site contamination. The Animal Investigation Program of the National Environmental Research Center, Las Vegas developed studies to document the distribution of fission and activation products in the tissue of domestic and wild animals residing within contaminated areas on and surrounding the Nevada Test Site. A study of radioiodine secretion in milk from cows at the experimental dairy farm, including urine and fecal excretion from four of them, was started about 24 hours after the venting. A grazing intake study, which utilized fistulated steers, was also carried out. The analytical data collected from these studies are presented in this report

  12. NEA incident reporting system: Three years' experience

    International Nuclear Information System (INIS)

    Otsuka, Y.; Haeussermann, W.

    1984-01-01

    The paper presents an overview of the NEA Incident Reporting System (IRS) which was set up to collect, assess and disseminate on safety-related incidents in nuclear power plants. The IRS information exchange is significant in two senses. First, it enables regulatory authorities and utilities in participating countries to take appropriate action to prevent the reported mishaps occurring again elsewhere. Secondly, the continuous collection and systematic analysis of such information allows identification of areas of concern where safety research should be strengthened. There are two stages in the IRS information exchange. First, the national IRS Co-ordinator selects information on significant incidents, in accordance with a common reporting threshold, from the abnormal occurrences reported to the regulatory body, to be distributed through the NEA Secretariat. This screening is intended to exclude minor events, so that only significant information is sent to participating countries. Secondly, a group of experts periodically reviews the incidents reported during the preceding twelve months to identify major areas of concern. To assist this process, a computer-based data retrieval system is being developed for IRS incident reports. The paper gives some details of the IRS mechanism and discusses reporting criteria and the information included in a report. Areas of concern derived from reported incidents, an outline of the data retrieval system, and examples of feedback of lessons learned and possibilities for international co-operation are also discussed. (author)

  13. VA Suicide Prevention Applications Network: A National Health Care System-Based Suicide Event Tracking System.

    Science.gov (United States)

    Hoffmire, Claire; Stephens, Brady; Morley, Sybil; Thompson, Caitlin; Kemp, Janet; Bossarte, Robert M

    2016-11-01

    The US Department of Veterans Affairs' Suicide Prevention Applications Network (SPAN) is a national system for suicide event tracking and case management. The objective of this study was to assess data on suicide attempts among people using Veterans Health Administration (VHA) services. We assessed the degree of data overlap on suicide attempters reported in SPAN and the VHA's medical records from October 1, 2010, to September 30, 2014-overall, by year, and by region. Data on suicide attempters in the VHA's medical records consisted of diagnoses documented with E95 codes from the International Classification of Diseases, Ninth Revision . Of 50 518 VHA patients who attempted suicide during the 4-year study period, data on fewer than half (41%) were reported in both SPAN and the medical records; nearly 65% of patients whose suicide attempt was recorded in SPAN had no data on attempted suicide in the VHA's medical records. Evaluation of administrative data suggests that use of SPAN substantially increases the collection of data on suicide attempters as compared with the use of medical records alone, but neither SPAN nor the VHA's medical records identify all suicide attempters. Further research is needed to better understand the strengths and limitations of both systems and how to best combine information across systems.

  14. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat

    DEFF Research Database (Denmark)

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I; Gøtzsche, Peter C

    2016-01-01

    BACKGROUND: Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe......Med and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about...

  15. Discrete Event Supervisory Control Applied to Propulsion Systems

    Science.gov (United States)

    Litt, Jonathan S.; Shah, Neerav

    2005-01-01

    The theory of discrete event supervisory (DES) control was applied to the optimal control of a twin-engine aircraft propulsion system and demonstrated in a simulation. The supervisory control, which is implemented as a finite-state automaton, oversees the behavior of a system and manages it in such a way that it maximizes a performance criterion, similar to a traditional optimal control problem. DES controllers can be nested such that a high-level controller supervises multiple lower level controllers. This structure can be expanded to control huge, complex systems, providing optimal performance and increasing autonomy with each additional level. The DES control strategy for propulsion systems was validated using a distributed testbed consisting of multiple computers--each representing a module of the overall propulsion system--to simulate real-time hardware-in-the-loop testing. In the first experiment, DES control was applied to the operation of a nonlinear simulation of a turbofan engine (running in closed loop using its own feedback controller) to minimize engine structural damage caused by a combination of thermal and structural loads. This enables increased on-wing time for the engine through better management of the engine-component life usage. Thus, the engine-level DES acts as a life-extending controller through its interaction with and manipulation of the engine s operation.

  16. Summary and bibliography of safety-related events at boiling-water nuclear power plants as reported in 1980

    Energy Technology Data Exchange (ETDEWEB)

    McCormack, K.E.; Gallaher, R.B.

    1982-03-01

    This document presents a bibliography that contains 100-word abstracts of event reports submitted to the US Nuclear Regulatory Commission concerning operational events that occurred at boiling-water-reactor nuclear power plants in 1980. The 1547 abstracts included on microfiche in this bibliography describe incidents, failures, and design or construction deficiencies that were experienced at the facilities. These abstracts are arranged alphabetically by reactor name and then chronologically for each reactor. Full-size keyword and permuted-title indexes to facilitate location of individual abstracts are provided following the text. Tables that summarize the information contained in the bibliography are also provided. The information in the tables includes a listing of the equipment items involved in the reported events and the associated number of reports for each item. Similar information is given for the various kinds of instrumentation and systems, causes of failures, deficiencies noted, and the time of occurrence (i.e., during refueling, operation, testing, or construction).

  17. NASA Aviation Safety Reporting System (ASRS)

    Science.gov (United States)

    Connell, Linda J.

    2017-01-01

    The NASA Aviation Safety Reporting System (ASRS) collects, analyzes, and distributes de-identified safety information provided through confidentially submitted reports from frontline aviation personnel. Since its inception in 1976, the ASRS has collected over 1.4 million reports and has never breached the identity of the people sharing their information about events or safety issues. From this volume of data, the ASRS has released over 6,000 aviation safety alerts concerning potential hazards and safety concerns. The ASRS processes these reports, evaluates the information, and provides selected de-identified report information through the online ASRS Database at http:asrs.arc.nasa.gov. The NASA ASRS is also a founding member of the International Confidential Aviation Safety Systems (ICASS) group which is a collection of other national aviation reporting systems throughout the world. The ASRS model has also been replicated for application to improving safety in railroad, medical, fire fighting, and other domains. This presentation will discuss confidential, voluntary, and non-punitive reporting systems and their advantages in providing information for safety improvements.

  18. [Current movements of four serious adverse events induced by medicinal drugs based on spontaneous reports in Japan].

    Science.gov (United States)

    Sudo, Chie; Azuma, Yu-ichiro; Maekawa, Keiko; Kaniwa, Nahoko; Sai, Kimie; Saito, Yoshiro

    2011-01-01

    Spontaneous reports on suspected serious adverse events caused by medicines from manufacturing/distributing pharmaceutical companies or medical institutions/pharmacies are regulated by the Pharmaceutical Affairs Law of Japan, and this system is important for post-marketing safety features. Although causal relationship between the medicine and the adverse event is not evaluated, and one incidence may be redundantly reported, this information would be useful to roughly grasp the current movements of drug-related serious adverse events, We searched open-source data of the spontaneous reports publicized by Pharmaceutical and Medical Devices Agency for 4 serious adverse events (interstitial lung disease, rhabdomyolysis, anaphylaxis, and Stevens-Johnson syndrome/toxic epidermal necrolysis) from 2004 to 2010 fiscal year (for 2010, from April 1 st to January 31th). Major drug-classes suspected to the adverse events were antineoplastics for interstitial lung disease, hyperlipidemia agents and psychotropics for rhabdomyolysis, antibiotics/chemotherapeutics, antineoplastics and intracorporeal diagnostic agents for anaphylaxis (anaphylactic shock, anaphylactic reactions, anaphylactoid shock and anaphylactoid reactions), and antibiotics/chemotherapeutics, antipyretics and analgesics, anti-inflammatory agents/common cold drugs, and antiepileptics for Stevens-Johnson syndrome/toxic epidermal necrolysis. These results would help understanding of current situations of the 4 drug-related serious adverse events in Japan.

  19. The nature and causes of unintended events reported at ten emergency departments

    Directory of Open Access Journals (Sweden)

    van der Wal Gerrit

    2009-09-01

    Full Text Available Abstract Background Several studies on patient safety have shown that a substantial number of patients suffer from unintended harm caused by healthcare management in hospitals. Emergency departments (EDs are challenging hospital settings with regard to patient safety. There is an increased sense of urgency to take effective countermeasures in order to improve patient safety. This can only be achieved if interventions tackle the dominant underlying causes. The objectives of our study are to examine the nature and causes of unintended events in EDs and the relationship between type of event and causal factor structure. Methods Study at EDs of 10 hospitals in the Netherlands. The study period per ED was 8 to 14 weeks, in which staff were asked to report unintended events. Unintended events were broadly defined as all events, no matter how seemingly trivial or commonplace, that were unintended and could have harmed or did harm a patient. Reports were analysed with a Root Cause Analysis tool (PRISMA by an experienced researcher. Results 522 unintended events were reported. Of the events 25% was related to cooperation with other departments and 20% to problems with materials/equipment. More than half of the events had consequences for the patient, most often resulting in inconvenience or suboptimal care. Most root causes were human (60%, followed by organisational (25% and technical causes (11%. Nearly half of the root causes was external, i.e. attributable to other departments in or outside the hospital. Conclusion Event reporting gives insight into diverse unintended events. The information on unintended events may help target research and interventions to increase patient safety. It seems worthwhile to direct interventions on the collaboration between the ED and other hospital departments.

  20. Severe Space Weather Events--Understanding Societal and Economic Impacts: A Workshop Report - Extended Summary

    Science.gov (United States)

    2009-01-01

    The effects of space weather on modern technological systems are well documented in both the technical literature and popular accounts. Most often cited perhaps is the collapse within 90 seconds of northeastern Canada's Hydro-Quebec power grid during the great geomagnetic storm of March 1989, which left millions of people without electricity for up to 9 hours. This event exemplifies the dramatic impact that severe space weather can have on a technology upon which modern society critically depends. Nearly two decades have passed since the March 1989 event. During that time, awareness of the risks of severe space weather has increased among the affected industries, mitigation strategies have been developed, new sources of data have become available, new models of the space environment have been created, and a national space weather infrastructure has evolved to provide data, alerts, and forecasts to an increasing number of users. Now, 20 years later and approaching a new interval of increased solar activity, how well equipped are we to manage the effects of space weather? Have recent technological developments made our critical technologies more or less vulnerable? How well do we understand the broader societal and economic impacts of severe space weather events? Are our institutions prepared to cope with the effects of a 'space weather Katrina,' a rare, but according to the historical record, not inconceivable eventuality? On May 22 and 23, 2008, a one-and-a-half-day workshop held in Washington, D.C., under the auspices of the National Research Council's (NRC's) Space Studies Board brought together representatives of industry, the federal government, and the social science community to explore these and related questions. The key themes, ideas, and insights that emerged during the presentations and discussions are summarized in 'Severe Space Weather Events--Understanding Societal and Economic Impacts: A Workshop Report' (The National Academies Press, Washington, D

  1. Development of requirements and functional specifications for crash event data recorders : final report

    Science.gov (United States)

    2004-12-01

    The U.S. DOT has conducted research on the requirements for a Crash Event Data Recorder to facilitate the reconstruction of commercial motor vehicle crashes. This report documents the work performed on the Development of Requirements and Functiona...

  2. Self reported stressful life events and exacerbations in multiple sclerosis: prospective study

    NARCIS (Netherlands)

    D. Buljevac (Dragan); W.C.J. Hop (Wim); W. Reedeker; A.C.J.W. Janssens (Cécile); F.G.A. van der Meché (Frans); P.A. van Doorn (Pieter); R.Q. Hintzen (Rogier)

    2003-01-01

    textabstractOBJECTIVE: To study the relation between self reported stressful life events not related to multiple sclerosis and the occurrence of exacerbations in relapsing-remitting multiple sclerosis. DESIGN: Longitudinal, prospective cohort study. SETTING: Outpatient clinic of

  3. Water Fluoridation Reporting System (Public Water Systems)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Water Fluoridation Reporting System (WFRS) has been developed to provide tools to assist states in managing fluoridation programs. WFRS is designed to track all...

  4. Undetected latent failures of safety-related systems. Preliminary survey of events in nuclear power plants 1980-1997

    Energy Technology Data Exchange (ETDEWEB)

    Lydell, B. [RSA Technologies, Vista, CA (United States)

    1998-03-01

    This report summarizes results and insights from a preliminary survey of events involving undetected, latent failures of safety-related systems. The survey was limited to events where mispositioned equipment (e.g., valves, switches) remained undetected, thus rendering standby equipment or systems unavailable for short or long time periods. Typically, these events were symptoms of underlying latent errors (e.g., design errors, procedure errors, unanalyzed safety conditions) and programmatic errors. The preliminary survey identified well over 300 events. Of these, 95 events are documented in this report. Events involving mispositioned equipment are commonplace. Most events are discovered soon after occurrence, however. But as evidenced by the survey results, some events remained undetected beyond several shift changes. The recommendations developed by the survey emphasize the importance of applying modern root cause analysis techniques to the event analysis to ensure that the causes and implications of occurred events are fully understood. 7 refs, 4 tabs, 3 figs. Also available at the SKI Home page: //www.ski.se.

  5. Facilitated Nurse Medication-Related Event Reporting to Improve Medication Management Quality and Safety in Intensive Care Units.

    Science.gov (United States)

    Xu, Jie; Reale, Carrie; Slagle, Jason M; Anders, Shilo; Shotwell, Matthew S; Dresselhaus, Timothy; Weinger, Matthew B

    Medication safety presents an ongoing challenge for nurses working in complex, fast-paced, intensive care unit (ICU) environments. Studying ICU nurse's medication management-especially medication-related events (MREs)-provides an approach to analyze and improve medication safety and quality. The goal of this study was to explore the utility of facilitated MRE reporting in identifying system deficiencies and the relationship between MREs and nurses' work in the ICUs. We conducted 124 structured 4-hour observations of nurses in three different ICUs. Each observation included measurement of nurse's moment-to-moment activity and self-reports of workload and negative mood. The observer then obtained MRE reports from the nurse using a structured tool. The MREs were analyzed by three experts. MREs were reported in 35% of observations. The 60 total MREs included four medication errors and seven adverse drug events. Of the 49 remaining MREs, 65% were associated with negative patient impact. Task/process deficiencies were the most common contributory factor for MREs. MRE occurrence was correlated with increased total task volume. MREs also correlated with increased workload, especially during night shifts. Most of these MREs would not be captured by traditional event reporting systems. Facilitated MRE reporting provides a robust information source about potential breakdowns in medication management safety and opportunities for system improvement.

  6. Modeling energy market dynamics using discrete event system simulation

    International Nuclear Information System (INIS)

    Gutierrez-Alcaraz, G.; Sheble, G.B.

    2009-01-01

    This paper proposes the use of Discrete Event System Simulation to study the interactions among fuel and electricity markets and consumers, and the decision-making processes of fuel companies (FUELCOs), generation companies (GENCOs), and consumers in a simple artificial energy market. In reality, since markets can reach a stable equilibrium or fail, it is important to observe how they behave in a dynamic framework. We consider a Nash-Cournot model in which marketers are depicted as Nash-Cournot players that determine supply to meet end-use consumption. Detailed engineering considerations such as transportation network flows are omitted, because the focus is upon the selection and use of appropriate market models to provide answers to policy questions. (author)

  7. Heavy ion microbeam system for study of single event effects

    International Nuclear Information System (INIS)

    Kamiya, Tomihiro; Utsunomiya, Nobuhiro; Minehara, Eiichi; Tanaka, Ryuichi; Ohmura, Miyoshi; Kohno, Kazuhiro; Iwamoto, Eiji.

    1992-01-01

    A high-energy heavy ion microbeam system has been developed and installed on a beam line of a 3 MV tandem electrostatic accelerator mainly for analysis of basic mechanism of single event upset (SEU) of semiconductor devices in spacecraft. The SEU is now the most serious problem for highly reliable spacecraft electronics system with long space mission. However, the mechanism has not been understood on the basis of microscopic process of SEU. The SEU phenomena depends not only upon hitting particles, but also upon the hit position on the microcircuit. To observe the transient charge pulse from a SEU, a single ion particle must hit exactly the desired position of the microcircuit. Such an experiment requires the microbeam spot size within 1 μm, the beam positioning accuracy within ±1 μm, and single ion hitting. The microbeam system has been designed to meet the above technical requirements. The system is equipped with two lens systems: one to control the target beam current in a wide range down to extremely low current without any change of the beam optics, and the other to focus heavy ion beams within a spot size of 1 μm. The final goal is to hit a microscopic target area with a single 15 MeV nickel ion. The beam spot size has been evaluated by Gaussian fitting of secondary electron profiles with microbeam scanning across the fine Cu mesh. The single ion detection has been also tested to generate a trigger signal for closing beam shutter to prevent further hits. This paper outlines the new microbeam system and describes methods to realize these techniques. (author)

  8. Extreme climatic events: reducing ecological and social systems vulnerabilities

    International Nuclear Information System (INIS)

    Decamps, H.; Amatore, C.; Bach, J.F.; Baccelli, F.; Balian, R.; Carpentier, A.; Charnay, P.; Cuzin, F.; Davier, M.; Dercourt, J.; Dumas, C.; Encrenaz, P.; Jeannerod, M.; Kahane, J.P.; Meunier, B.; Rebut, P.H.; Salencon, J.; Spitz, E.; Suquet, P.; Taquet, P.; Valleron, A.J.; Yoccoz, J.C.; Chapron, J.Y.; Fanon, J.; Andre, J.C.; Auger, P.; Bourrelier, P.H.; Combes, C.; Derrida, B.; Laubier, L.; Laval, K.; Le Maho, Y.; Marsily, G. De; Petit, M.; Schmidt-Laine, C.; Birot, Y.; Peyron, J.L.; Seguin, B.; Barles, S.; Besancenot, J.P.; Michel-Kerjan, E.; Hallegatte, S.; Dumas, P.; Ancey, V.; Requier-Desjardins, M.; Ducharnes, A.; Ciais, P.; Peylin, P.; Kaniewski, D.; Van Campo, E.; Planton, S.; Manuguerra, J.C.; Le Bars, Y.; Lagadec, P.; Kessler, D.; Pontikis, C.; Nussbaum, R.

    2010-01-01

    The Earth has to face more and more devastating extreme events. Between 1970 and 2009, at the worldwide scale, the 25 most costly catastrophes all took place after 1987, and for more than half of them after 2001. Among these 25 catastrophes, 23 were linked to climate conditions. France was not spared: the December 1999 storms led to 88 deaths, deprived 3.5 million households of electricity and costed more than 9 billion euros. The 2003 heat wave led to about 15000 supernumerary deaths between August 1 and August 20. The recent Xynthia storm, with its flood barrier ruptures, provoked 53 deaths in addition to many other tragedies that took place in areas liable to flooding. In the present day context of climate change, we know that we must be prepared to even more dangerous events, sometimes unexpected before. These events can have amplified effects because of the urban development, the overpopulation of coastal areas and the anthropization of natural environments. They represent real 'poverty traps' for the poorest countries of the Earth. The anticipation need is real but is our country ready to answer it? Does it have a sufficient contribution to international actions aiming at reducing risks? Is his scientific information suitable? France is not less vulnerable than other countries. It must reinforce its prevention, its response and resilience capacities in the framework of integrated policies of catastrophes risk management as well as in the framework of climate change adaptation plans. This reinforcement supposes the development of vigilance systems with a better risk coverage and benefiting by the advances gained in the meteorology and health domains. It supposes a town and country planning allowing to improve the viability of ecological and social systems - in particular by protecting their diversity. Finally, this reinforcement requires inciting financial coverage solutions for catastrophes prevention and for their management once they have taken place. A

  9. Nurse willingness to report for work in the event of an earthquake in Israel.

    Science.gov (United States)

    Ben Natan, Merav; Nigel, Simon; Yevdayev, Innush; Qadan, Mohamad; Dudkiewicz, Mickey

    2014-10-01

    To examine variables affecting nurse willingness to report for work in the event of an earthquake in Israel and whether this can be predicted through the Theory of Self-Efficacy. The nursing profession has a major role in preparing for earthquakes. Nurse willingness to report to work in the event of an earthquake has never before been examined. Self-administered questionnaires were distributed among a convenience sample of 400 nurses and nursing students in Israel during January-April 2012. High willingness to report to work in the event of an earthquake was declared by 57% of respondents. High perceived self-efficacy, level of knowledge and experience predict willingness to report to work in the event of an earthquake. Multidisciplinary collaboration and support was also cited as a meaningful factor. Perceived self-efficacy, level of knowledge, experience and the support of a multidisciplinary staff affect nurse willingness to report to work in the event of an earthquake. Nurse managers can identify factors that increase nurse willingness to report to work in the event of an earthquake and consequently develop strategies for more efficient management of their nursing workforce. © 2013 John Wiley & Sons Ltd.

  10. Incidents in transport of radioactive materials for civil use: IRSN draws lessons from events reported between 1999 and 2007

    International Nuclear Information System (INIS)

    2008-01-01

    Some 900,000 packages of radioactive materials for civil use are transported each year in France. The great majority of these shipments involve radioactive materials used in the fields of medicine, pharmaceuticals, industry or property. Transport of radioactive materials linked to the nuclear fuel cycle actually represents only 15% of transport. A great variety of material is transported, differing in weight (from a few grams to tens of tons), form, activity and packaging. The associated risks are also different: radioactive contamination, external exposure to ionising radiation, chemical risk etc. In its role of technical support to safety and radioprotection authorities, IRSN's mission is to assess the design, manufacturing, testing and use of packaging and transport systems. The Institute is also involved in the management and analysis of events that occur during transport of radioactive materials. To assist with this, the IRSN manages a database which lists reported deviations, anomalies, incidents and accidents (known in a generic way as 'events') relating to transport. With an aim of reduction of the risks related to transport, the feedback resulting from the thorough analysis of the notified events is capitalized by IRSN, just as the feedback of the assessments of the safety analysis reports of the various package designs. Based on these feedbacks, IRSN proposes axes of improvement relating to package designs and transport operations, and regulatory evolutions, as well as priority topics for the inspections carried out by the French Nuclear safety authority (ASN). The IRSN has carried out a transversal analysis of all events in transport of radioactive materials that occurred in France from 1999 to 2007 as listed in its database (i.e. 901 events). For each event, some 70 parameters have been recorded from the analysis of the notifications and reports of the events, transmitted by the operators (type of event, type of package, level on the INES scale). This

  11. Vaccine Adverse Events Reported during the First Ten Years (1998–2008 after Introduction in the State of Rondonia, Brazil

    Directory of Open Access Journals (Sweden)

    Mônica P. L. Cunha

    2013-01-01

    Full Text Available Despite good safety records, vaccines given to young children can cause adverse events. We investigated the reported adverse events following immunization (AEFI of vaccines given to children of less than seven years of age during the first ten years (1998 to 2008 in the state of Rondonia, Brazil. We worked with the events related to BCG (Bacillus Calmett-Guérin, HB (hepatitis B, DTwP/Hib (diphtheria-tetanus-pertussis+Hemophillus influenza b, DTP (diphtheria-tetanus-pertussis, MMR (mumps, measles, rubella, and YF (yellow fever vaccines because they were part of the recommended scheme. The number of doses of vaccines given was 3,231,567 with an average of AEFI of 57.2/year during the studied period. DTwP/Hib was responsible for 298 (57.8%, DTP 114 (22.9%, HB 31 (6%, MMR 28 (5.4%, BCG 24 (4.7%, and YF 20 (3.9% of the reported AEFI. The combination of the AEFI for DTwP/Hib vaccines showed the highest number of systemic (61.4% and local events (33.8%. Young children (≤1-year old were more susceptible to AEFI occurring in the 6 hours (54.2% following vaccine uptake. This study suggests significant differences in reactogenicity of vaccines and that despite limitations of the AEFI Brazilian registry system we cannot ignore underreporting and should use the system to expand our understanding of adverse events and effects.

  12. State-feedback control of fuzzy discrete-event systems.

    Science.gov (United States)

    Lin, Feng; Ying, Hao

    2010-06-01

    In a 2002 paper, we combined fuzzy logic with discrete-event systems (DESs) and established an automaton model of fuzzy DESs (FDESs). The model can effectively represent deterministic uncertainties and vagueness, as well as human subjective observation and judgment inherent to many real-world problems, particularly those in biomedicine. We also investigated optimal control of FDESs and applied the results to optimize HIV/AIDS treatments for individual patients. Since then, other researchers have investigated supervisory control problems in FDESs, and several results have been obtained. These results are mostly derived by extending the traditional supervisory control of (crisp) DESs, which are string based. In this paper, we develop state-feedback control of FDESs that is different from the supervisory control extensions. We use state space to describe the system behaviors and use state feedback in control. Both disablement and enforcement are allowed. Furthermore, we study controllability based on the state space and prove that a controller exists if and only if the controlled system behavior is (state-based) controllable. We discuss various properties of the state-based controllability. Aside from novelty, the proposed new framework has the advantages of being able to address a wide range of practical problems that cannot be effectively dealt with by existing approaches. We use the diabetes treatment as an example to illustrate some key aspects of our theoretical results.

  13. Fault diagnosis for discrete event systems: Modelling and verification

    International Nuclear Information System (INIS)

    Simeu-Abazi, Zineb; Di Mascolo, Maria; Knotek, Michal

    2010-01-01

    This paper proposes an effective way for diagnosis of discrete-event systems using a timed-automaton. It is based on the model-checking technique, thanks to time analysis of the timed model. The paper proposes a method to construct all the timed models and details the different steps used to obtain the diagnosis path. A dynamic model with temporal transitions is proposed in order to model the system. By 'dynamical model', we mean an extension of timed automata for which the faulty states are identified. The model of the studied system contains the faultless functioning states and all the faulty states. Our method is based on the backward exploitation of the dynamic model, where all possible reverse paths are searched. The reverse path is the connection of the faulty state to the initial state. The diagnosis method is based on the coherence between the faulty occurrence time and the reverse path length. A real-world batch process is used to demonstrate the modelling steps and the proposed backward time analysis method to reach the diagnosis results.

  14. Adverse events reported to the Food and Drug Administration from 2004 to 2016 for cosmetics and personal care products marketed to newborns and infants.

    Science.gov (United States)

    Cornell, Erika; Kwa, Michael; Paller, Amy S; Xu, Shuai

    2018-03-01

    Despite their ubiquitous use and several recent health controversies involving cosmetics and personal care products for children, the Food and Drug Administration has little oversight of these products and relies on consumer-submitted adverse event reports. We assessed the recently released Center for Food Safety and Applied Nutrition's Adverse Event Reporting System database for adverse event reports submitted to the Food and Drug Administration for baby personal care products and to determine whether useful insights can be derived. We extracted the Center for Food Safety and Applied Nutrition's Adverse Event Reporting System data file from 2004 to 2016 and examined the subset classified according to the Food and Drug Administration-designated product class as a baby product. Events were manually categorized into product type and symptom type to assess for trends. Only 166 total adverse events were reported to the Food and Drug Administration for baby products from 2004 to 2016. The majority of reports indicated rash or other skin reaction; 46% of reported events led to a health care visit. Pediatric dermatologists should consider submitting cosmetics and personal care product adverse event reports and encouraging consumers to do so likewise in situations in which a product adversely affects a child's health. © 2018 Wiley Periodicals, Inc.

  15. Medication Exposures and Subsequent Development of Ewing Sarcoma: A Review of FDA Adverse Event Reports

    Directory of Open Access Journals (Sweden)

    Judith U. Cope

    2015-01-01

    Full Text Available Background. Ewing sarcoma family of tumors (ESFT are rare but deadly cancers of unknown etiology. Few risk factors have been identified. This study was undertaken to ascertain any possible association between exposure to therapeutic drugs and ESFT. Methods. This is a retrospective, descriptive study. A query of the FDA Adverse Event Reporting System (FAERS was conducted for all reports of ESFT, January 1, 1998, through December 31, 2013. Report narratives were individually reviewed for patient characteristics, underlying conditions and drug exposures. Results. Over 16 years, 134 ESFT reports were identified, including 25 cases of ESFT following therapeutic drugs and biologics including immunosuppressive agents and hormones. Many cases were confounded by concomitant medications and other therapies. Conclusions. This study provides a closer look at medication use and underlying disorders in patients who later developed ESFT. While this study was not designed to demonstrate any clear causative association between ESFT and prior use of a single product or drug class, many drugs were used to treat immune-related disease and growth or hormonal disturbances. Further studies may be warranted to better understand possible immune or neuroendocrine abnormalities or exposure to specific classes of drugs that may predispose to the later development of ESFT.

  16. Synchronous Parallel Emulation and Discrete Event Simulation System with Self-Contained Simulation Objects and Active Event Objects

    Science.gov (United States)

    Steinman, Jeffrey S. (Inventor)

    1998-01-01

    The present invention is embodied in a method of performing object-oriented simulation and a system having inter-connected processor nodes operating in parallel to simulate mutual interactions of a set of discrete simulation objects distributed among the nodes as a sequence of discrete events changing state variables of respective simulation objects so as to generate new event-defining messages addressed to respective ones of the nodes. The object-oriented simulation is performed at each one of the nodes by assigning passive self-contained simulation objects to each one of the nodes, responding to messages received at one node by generating corresponding active event objects having user-defined inherent capabilities and individual time stamps and corresponding to respective events affecting one of the passive self-contained simulation objects of the one node, restricting the respective passive self-contained simulation objects to only providing and receiving information from die respective active event objects, requesting information and changing variables within a passive self-contained simulation object by the active event object, and producing corresponding messages specifying events resulting therefrom by the active event objects.

  17. Vessel Electronic Reporting System (VERS)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The VERS system is composed of a database and other related applications which facilitate the reporting of electronically collected research data via Fisheries...

  18. Perioperative anaesthetic adverse events in Thailand (PAAd THAI) study: Incident report of perioperative convulsion.

    Science.gov (United States)

    Eiamcharoenwit, Jatuporn; Akavipat, Phuping; Ariyanuchitkul, Thidarat; Wirachpisit, Nichawan; Pulnitiporn, Aksorn; Pongraweewan, Orawan

    2018-01-01

    The aim of this study was to identify the characteristics of perioperative convulsion and to suggest possible correcting strategies. The multi-centre study was conducted prospectively in 22 hospitals across Thailand in 2015. The occurrences of perioperative adverse events were collected. The data was collated by site manager and forwarded to the data management unit. All perioperative convulsion incidences were enrolled and analysed. The consensus was documented for the relevant factors and the corrective strategies. Descriptive statistics were used. From 2,000 incident reports, perioperative convulsions were found in 16 patients. Six episodes (37.5%) were related to anaesthesia, 31.3% to patients, 18.8% to surgery, and 12.5% to systemic processes. The contributing factor was an inexperienced anaesthesia performer (25%), while the corrective strategy was improvements to supervision (43.8%). Incidents of perioperative convulsion were found to be higher than during the last decade. The initiation and maintenance of safe anaesthesia should be continued.

  19. SPECTR System Operational Test Report

    International Nuclear Information System (INIS)

    Landman, W.H. Jr.

    2011-01-01

    This report overviews installation of the Small Pressure Cycling Test Rig (SPECTR) and documents the system operational testing performed to demonstrate that it meets the requirements for operations. The system operational testing involved operation of the furnace system to the design conditions and demonstration of the test article gas supply system using a simulated test article. The furnace and test article systems were demonstrated to meet the design requirements for the Next Generation Nuclear Plant. Therefore, the system is deemed acceptable and is ready for actual test article testing.

  20. Adverse event reporting in Slovenia - the influence of safety culture, supervisors and communication

    Directory of Open Access Journals (Sweden)

    Birk Karin

    2016-01-01

    Full Text Available Background/Aim. The provision of safe healthcare is considered a priority in European Union (EU member states. Along with other preventative measures in healthcare, the EU also strives to eliminate the “causes of harm to human health”. The aim of this survey was to determine whether safety culture, supervisors and communication between co-workers influence the number of adverse event reports submitted to the heads of clinical departments and to the management of an institution. Methods. This survey is based on cross-sectional analysis. It was carried out in the largest Slovenian university hospital. We received 235 completed questionnaires. Respondents included professionals in the fields of nursingcare, physiotherapy, occupational therapy and radiological technology. Results. Safety culture influences the number of adverse event reports submitted to the head of a clinical department from the organizational point of view. Supervisors and communication between co-workers do not influence the number of adverse event reports. Conclusion. It can be concluded that neither supervisors nor the level of communication between co-workers influence the frequency of adverse event reporting, while safety culture does influence it from an organizational point of view. The presumed factors only partly influence the number of submitted adverse event reports, thus other causes of under-reporting must be sought elsewhere.

  1. Lunar Rocks: Available for Year of the Solar System Events

    Science.gov (United States)

    Allen, J. S.

    2010-12-01

    sections may be use requested for college and university courses where petrographic microscopes are available for viewing. Requestors should contact Ms. Mary Luckey, Education Sample Curator. Email address: mary.k.luckey@nasa.gov NASA also loans sets of Moon rocks for use in classrooms, libraries, museums, and planetariums through the Lunar Sample Education Program. Lunar samples (three soils and three rocks) are encapsulated in a six-inch diameter clear plastic disk. A CD with PowerPoint presentations, analogue samples from Earth, a classroom activity guide, and additional printed material accompany the disks. Educators may qualify for the use of these disks by attending a content and security certification workshop sponsored by NASA's Aerospace Education Services Program (AESP). Contact Ms. Margaret Maher, AESP Director. Email address: mjm67@psu.edu NASA makes these precious samples available for the public and encourages the use of lunar rocks to highlight Year of the Solar System events. Surely these interesting specimens of another world will enhance the experience of all YSS participants so please take advantage of these lunar samples and borrow them for events and classes.

  2. 76 FR 57045 - Announcement of Requirements and Registration for “Reporting Device Adverse Events Challenge”

    Science.gov (United States)

    2011-09-15

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Announcement of Requirements and Registration for ``Reporting Device Adverse Events Challenge'' Authority: 15 U.S.C. 3719. AGENCY: Office of the National..., specifically as it relates to monitoring product safety and effectiveness. The ``Reporting Device Adverse...

  3. The validity of a patient-reported adverse drug event questionnaire using different recall periods

    NARCIS (Netherlands)

    de Vries, Sieta T; Haaijer-Ruskamp, Flora M; de Zeeuw, Dick; Denig, Petra

    2014-01-01

    PURPOSE: To assess the validity of a patient-reported adverse drug events (ADEs) questionnaire with a 3-month or 4-week recall period. METHODS: Patients receiving at least one oral glucose-lowering drug were asked to report potential ADEs they experienced related to any drug in a daily diary for a

  4. Despite 2007 law requiring FDA hotline to be included in print drug ads, reporting of adverse events by consumers still low.

    Science.gov (United States)

    Du, Dongyi; Goldsmith, John; Aikin, Kathryn J; Encinosa, William E; Nardinelli, Clark

    2012-05-01

    In 2007 the federal government began requiring drug makers to include in their print direct-to-consumer advertisements information for consumers on how to contact the Food and Drug Administration directly, either by phone or through the agency's website, to report any adverse events that they experienced after taking a prescription drug. Adverse events can range from minor skin problems like itching to serious injuries or illness that result in hospitalization, permanent disability, or even death. Even so, current rates of adverse event reporting are low. We studied adverse event reports about 123 drugs that came from patients before and after the enactment of the print advertising requirement and estimated that requirement's impact with model simulations. We found that if monthly spending on print direct-to-consumer advertising increased from zero to $7.7 million per drug, the presence of the Food and Drug Administration contact information tripled the increase in patient-reported adverse events, compared to what would have happened in the absence of the law. However, the absolute monthly increase was fewer than 0.24 reports per drug, suggesting that the public health impact of the increase was small and that the adverse event reporting rate would still be low. The study results suggest that additional measures, such as more publicity about the Adverse Event Reporting System or more consumer education, should be considered to promote patient reporting of adverse events.

  5. 2014 Runtime Systems Summit. Runtime Systems Report

    Energy Technology Data Exchange (ETDEWEB)

    Sarkar, Vivek [US Dept. of Energy, Washington, DC (United States); Budimlic, Zoran [US Dept. of Energy, Washington, DC (United States); Kulkani, Milind [US Dept. of Energy, Washington, DC (United States)

    2016-09-19

    This report summarizes runtime system challenges for exascale computing, that follow from the fundamental challenges for exascale systems that have been well studied in past reports, e.g., [6, 33, 34, 32, 24]. Some of the key exascale challenges that pertain to runtime systems include parallelism, energy efficiency, memory hierarchies, data movement, heterogeneous processors and memories, resilience, performance variability, dynamic resource allocation, performance portability, and interoperability with legacy code. In addition to summarizing these challenges, the report also outlines different approaches to addressing these significant challenges that have been pursued by research projects in the DOE-sponsored X-Stack and OS/R programs. Since there is often confusion as to what exactly the term “runtime system” refers to in the software stack, we include a section on taxonomy to clarify the terminology used by participants in these research projects. In addition, we include a section on deployment opportunities for vendors and government labs to build on the research results from these projects. Finally, this report is also intended to provide a framework for discussing future research and development investments for exascale runtime systems, and for clarifying the role of runtime systems in exascale software.

  6. The effects of power, leadership and psychological safety on resident event reporting.

    Science.gov (United States)

    Appelbaum, Nital P; Dow, Alan; Mazmanian, Paul E; Jundt, Dustin K; Appelbaum, Eric N

    2016-03-01

    Although the reporting of adverse events is a necessary first step in identifying and addressing lapses in patient safety, such events are under-reported, especially by frontline providers such as resident physicians. This study describes and tests relationships between power distance and leader inclusiveness on psychological safety and the willingness of residents to report adverse events. A total of 106 resident physicians from the departments of neurosurgery, orthopaedic surgery, emergency medicine, otolaryngology, neurology, obstetrics and gynaecology, paediatrics and general surgery in a mid-Atlantic teaching hospital were asked to complete a survey on psychological safety, perceived power distance, leader inclusiveness and intention to report adverse events. Perceived power distance (β = -0.26, standard error [SE] 0.06, 95% confidence interval [CI] -0.37 to 0.15; p leadership practices build psychological safety and minimise power distance between low- and high-status members in order to support greater reporting of adverse events. © 2016 John Wiley & Sons Ltd.

  7. Reverse translation of adverse event reports paves the way for de-risking preclinical off-targets.

    Science.gov (United States)

    Maciejewski, Mateusz; Lounkine, Eugen; Whitebread, Steven; Farmer, Pierre; DuMouchel, William; Shoichet, Brian K; Urban, Laszlo

    2017-08-08

    The Food and Drug Administration Adverse Event Reporting System (FAERS) remains the primary source for post-marketing pharmacovigilance. The system is largely un-curated, unstandardized, and lacks a method for linking drugs to the chemical structures of their active ingredients, increasing noise and artefactual trends. To address these problems, we mapped drugs to their ingredients and used natural language processing to classify and correlate drug events. Our analysis exposed key idiosyncrasies in FAERS, for example reports of thalidomide causing a deadly ADR when used against myeloma, a likely result of the disease itself; multiplications of the same report, unjustifiably increasing its importance; correlation of reported ADRs with public events, regulatory announcements, and with publications. Comparing the pharmacological, pharmacokinetic, and clinical ADR profiles of methylphenidate, aripiprazole, and risperidone, and of kinase drugs targeting the VEGF receptor, demonstrates how underlying molecular mechanisms can emerge from ADR co-analysis. The precautions and methods we describe may enable investigators to avoid confounding chemistry-based associations and reporting biases in FAERS, and illustrate how comparative analysis of ADRs can reveal underlying mechanisms.

  8. An Evaluation of Departmental Radiation Oncology Incident Reports: Anticipating a National Reporting System

    International Nuclear Information System (INIS)

    Terezakis, Stephanie A.; Harris, Kendra M.; Ford, Eric; Michalski, Jeff; DeWeese, Theodore; Santanam, Lakshmi; Mutic, Sasa; Gay, Hiram

    2013-01-01

    Purpose: Systems to ensure patient safety are of critical importance. The electronic incident reporting systems (IRS) of 2 large academic radiation oncology departments were evaluated for events that may be suitable for submission to a national reporting system (NRS). Methods and Materials: All events recorded in the combined IRS were evaluated from 2007 through 2010. Incidents were graded for potential severity using the validated French Nuclear Safety Authority (ASN) 5-point scale. These incidents were categorized into 7 groups: (1) human error, (2) software error, (3) hardware error, (4) error in communication between 2 humans, (5) error at the human-software interface, (6) error at the software-hardware interface, and (7) error at the human-hardware interface. Results: Between the 2 systems, 4407 incidents were reported. Of these events, 1507 (34%) were considered to have the potential for clinical consequences. Of these 1507 events, 149 (10%) were rated as having a potential severity of ≥2. Of these 149 events, the committee determined that 79 (53%) of these events would be submittable to a NRS of which the majority was related to human error or to the human-software interface. Conclusions: A significant number of incidents were identified in this analysis. The majority of events in this study were related to human error and to the human-software interface, further supporting the need for a NRS to facilitate field-wide learning and system improvement

  9. An Evaluation of Departmental Radiation Oncology Incident Reports: Anticipating a National Reporting System

    Energy Technology Data Exchange (ETDEWEB)

    Terezakis, Stephanie A., E-mail: stereza1@jhmi.edu [Department of Radiation Oncology and Molecular Radiation Sciences, The Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); Harris, Kendra M. [Department of Radiation Oncology and Molecular Radiation Sciences, The Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); Ford, Eric [Department of Radiation Oncology and Molecular Radiation Sciences, The Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); Department of Radiation Oncology, University of Washington, Seattle, Washington (United States); Michalski, Jeff [Department of Radiation Oncology, Washington University School of Medicine, St. Louis, Missouri (United States); DeWeese, Theodore [Department of Radiation Oncology and Molecular Radiation Sciences, The Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); Santanam, Lakshmi; Mutic, Sasa; Gay, Hiram [Department of Radiation Oncology, Washington University School of Medicine, St. Louis, Missouri (United States)

    2013-03-15

    Purpose: Systems to ensure patient safety are of critical importance. The electronic incident reporting systems (IRS) of 2 large academic radiation oncology departments were evaluated for events that may be suitable for submission to a national reporting system (NRS). Methods and Materials: All events recorded in the combined IRS were evaluated from 2007 through 2010. Incidents were graded for potential severity using the validated French Nuclear Safety Authority (ASN) 5-point scale. These incidents were categorized into 7 groups: (1) human error, (2) software error, (3) hardware error, (4) error in communication between 2 humans, (5) error at the human-software interface, (6) error at the software-hardware interface, and (7) error at the human-hardware interface. Results: Between the 2 systems, 4407 incidents were reported. Of these events, 1507 (34%) were considered to have the potential for clinical consequences. Of these 1507 events, 149 (10%) were rated as having a potential severity of ≥2. Of these 149 events, the committee determined that 79 (53%) of these events would be submittable to a NRS of which the majority was related to human error or to the human-software interface. Conclusions: A significant number of incidents were identified in this analysis. The majority of events in this study were related to human error and to the human-software interface, further supporting the need for a NRS to facilitate field-wide learning and system improvement.

  10. Adverse event reporting and developments in radiation biology after normal tissue injury: International Atomic Energy Agency consultation

    International Nuclear Information System (INIS)

    Chen Yuhchyau; Trotti, Andy; Coleman, C. Norman; Machtay, Mitchell; Mirimanoff, Rene O.; Hay, John; O'Brien, Peter C.; El-Gueddari, Brahim; Salvajoli, Joao V.; Jeremic, Branislav

    2006-01-01

    Purpose: Recent research has enhanced our understanding of radiation injury at the molecular-cellular and tissue levels; significant strides have occurred in standardization of adverse event reporting in clinical trials. In response, the International Atomic Energy Agency, through its Division of Human Health and its section for Applied Radiation Biology and Radiotherapy, organized a consultation meeting in Atlanta (October 2, 2004) to discuss developments in radiobiology, normal tissue reactions, and adverse event reporting. Methods and Materials: Representatives from cooperative groups of African Radiation Oncology Group, Curriculo Radioterapeutica Ibero Latino Americana, European Organization for Research and Treatment of Cancer, National Cancer Institute of Canada Clinical Trials Group, Radiation Therapy Oncology Group, and Trans-Tasman Radiation Oncology Group held the meeting discussion. Results: Representatives of major radiotherapy groups/organizations and prominent leaders in radiotherapy discussed current understanding of normal tissue radiobiologic effects, the design and implementation of future clinical and translational projects for normal tissue injury, and the standardization of adverse-event reporting worldwide. Conclusions: The consensus was to adopt NCI comprehensive adverse event reporting terminology and grading system (CTCAE v3.0) as the new standard for all cooperative group trials. Future plans included the implementation of coordinated research projects focusing on normal tissue biomarkers and data collection methods

  11. Real-time monitoring of clinical processes using complex event processing and transition systems.

    Science.gov (United States)

    Meinecke, Sebastian

    2014-01-01

    Dependencies between tasks in clinical processes are often complex and error-prone. Our aim is to describe a new approach for the automatic derivation of clinical events identified via the behaviour of IT systems using Complex Event Processing. Furthermore we map these events on transition systems to monitor crucial clinical processes in real-time for preventing and detecting erroneous situations.

  12. The event notification and alarm system for the Open Science Grid operations center

    Science.gov (United States)

    Hayashi, S.; Teige and, S.; Quick, R.

    2012-12-01

    The Open Science Grid Operations (OSG) Team operates a distributed set of services and tools that enable the utilization of the OSG by several HEP projects. Without these services users of the OSG would not be able to run jobs, locate resources, obtain information about the status of systems or generally use the OSG. For this reason these services must be highly available. This paper describes the automated monitoring and notification systems used to diagnose and report problems. Described here are the means used by OSG Operations to monitor systems such as physical facilities, network operations, server health, service availability and software error events. Once detected, an error condition generates a message sent to, for example, Email, SMS, Twitter, an Instant Message Server, etc. The mechanism being developed to integrate these monitoring systems into a prioritized and configurable alarming system is emphasized.

  13. The event notification and alarm system for the Open Science Grid operations center

    Energy Technology Data Exchange (ETDEWEB)

    Hayashi, S; Teige and, S; Quick, R [Indiana University, University Information Technology Services (United States)

    2012-12-13

    The Open Science Grid Operations (OSG) Team operates a distributed set of services and tools that enable the utilization of the OSG by several HEP projects. Without these services users of the OSG would not be able to run jobs, locate resources, obtain information about the status of systems or generally use the OSG. For this reason these services must be highly available. This paper describes the automated monitoring and notification systems used to diagnose and report problems. Described here are the means used by OSG Operations to monitor systems such as physical facilities, network operations, server health, service availability and software error events. Once detected, an error condition generates a message sent to, for example, Email, SMS, Twitter, an Instant Message Server, etc. The mechanism being developed to integrate these monitoring systems into a prioritized and configurable alarming system is emphasized.

  14. The event notification and alarm system for the Open Science Grid operations center

    International Nuclear Information System (INIS)

    Hayashi, S; Teige and, S; Quick, R

    2012-01-01

    The Open Science Grid Operations (OSG) Team operates a distributed set of services and tools that enable the utilization of the OSG by several HEP projects. Without these services users of the OSG would not be able to run jobs, locate resources, obtain information about the status of systems or generally use the OSG. For this reason these services must be highly available. This paper describes the automated monitoring and notification systems used to diagnose and report problems. Described here are the means used by OSG Operations to monitor systems such as physical facilities, network operations, server health, service availability and software error events. Once detected, an error condition generates a message sent to, for example, Email, SMS, Twitter, an Instant Message Server, etc. The mechanism being developed to integrate these monitoring systems into a prioritized and configurable alarming system is emphasized.

  15. The Object Event Calculus and Temporal Geographic Information Systems

    National Research Council Canada - National Science Library

    Schmidt, Thomas

    2003-01-01

    .... A brief review of temporal issues as applied to object-oriented databases is supplied. In our approach, the Event Calculus is used to provide a formalism that avoids the question of object timestamping by not applying time to objects...

  16. Guide on a national system for collecting, assessing and disseminating information on safety-related events in nuclear power plants

    International Nuclear Information System (INIS)

    1983-02-01

    There is a wide spectrum of safety significance in the events that can occur during nuclear power plant operations. It is important that lessons be learned from safety-related events (hereinafter referred to as unusual events) so as to improve the safety of nuclear power plants. Hence formal procedures should be established for this purpose. The purpose of this document is to provide guidance to Member States for establishing a system (hereinafter referred to as a national system) for collecting, storing, retrieving, assessing and disseminating information on unusual events in nuclear power plants. The guidance given is based on experience gained in the use of existing national and international systems. This guide covers a national system that is part of a programme to improve nuclear power plant safety using experience gained from operating plants both within and outside the country. Implementing the recommendations in this guide would render any national system compatible with other national systems and facilitate the participation in the IAEA System for Reporting Unusual Events with Safety Significance (hereinafter referred to as the IAEA Incident Reporting System, IAEA-IRS) for more widespread dissemination of lessons learned from nuclear power plant operation

  17. Experimental lithium system. Final report

    International Nuclear Information System (INIS)

    Kolowith, R.; Berg, J.D.; Miller, W.C.

    1985-04-01

    A full-scale mockup of the Fusion Materials Irradiation Test (FMIT) Facility lithium system was built at the Hanford Engineering Development Laboratory (HEDL). This isothermal mockup, called the Experimental Lithium System (ELS), was prototypic of FMIT, excluding the accelerator and dump heat exchanger. This 3.8 m 3 lithium test loop achieved over 16,000 hours of safe and reliable operation. An extensive test program demonstrated satisfactory performance of the system components, including the HEDL-supplied electromagnetic lithium pump, the lithium jet target, the purification and characterization hardware, as well as the auxiliary argon and vacuum systems. Experience with the test loop provided important information on system operation, performance, and reliability. This report presents a complete overview of the entire Experimental Lithium System test program and also includes a summary of such areas as instrumentation, coolant chemistry, vapor/aerosol transport, and corrosion

  18. A simple multiprocessor management system for event-parallel computing

    International Nuclear Information System (INIS)

    Bracker, S.; Gounder, K.; Hendrix, K.; Summers, D.

    1996-01-01

    Offline software using Transmission Control Protocol/Internet Protocol (TCP/IP) sockets to distribute particle physics events to multiple UNIX/RISC workstations is described. A modular, building block approach was taken that allowed tailoring to solve specific tasks efficiently and simply as they arose. The modest, initial cost was having to learn about sockets for interprocess communication. This multiprocessor management software has been used to control the reconstruction of eight billion raw data events from Fermilab Experiment E791

  19. Building a knowledge base of severe adverse drug events based on AERS reporting data using semantic web technologies.

    Science.gov (United States)

    Jiang, Guoqian; Wang, Liwei; Liu, Hongfang; Solbrig, Harold R; Chute, Christopher G

    2013-01-01

    A semantically coded knowledge base of adverse drug events (ADEs) with severity information is critical for clinical decision support systems and translational research applications. However it remains challenging to measure and identify the severity information of ADEs. The objective of the study is to develop and evaluate a semantic web based approach for building a knowledge base of severe ADEs based on the FDA Adverse Event Reporting System (AERS) reporting data. We utilized a normalized AERS reporting dataset and extracted putative drug-ADE pairs and their associated outcome codes in the domain of cardiac disorders. We validated the drug-ADE associations using ADE datasets from SIDe Effect Resource (SIDER) and the UMLS. We leveraged the Common Terminology Criteria for Adverse Event (CTCAE) grading system and classified the ADEs into the CTCAE in the Web Ontology Language (OWL). We identified and validated 2,444 unique Drug-ADE pairs in the domain of cardiac disorders, of which 760 pairs are in Grade 5, 775 pairs in Grade 4 and 2,196 pairs in Grade 3.

  20. Subscriber Response System. Progress Report.

    Science.gov (United States)

    Callais, Richard T.

    Results of preliminary tests made prior and subsequent to the installation of a two-way interactive communication system which involves a computer complex termed the Local Processing Center and subscriber terminals located in the home or business location are reported. This first phase of the overall test plan includes tests made at Theta-Com…

  1. NASA aviation safety reporting system

    Science.gov (United States)

    1981-01-01

    Aviation safety reports that relate to loss of control in flight, problems that occur as a result of similar sounding alphanumerics, and pilot incapacitation are presented. Problems related to the go around maneuver in air carrier operations, and bulletins (and FAA responses to them) that pertain to air traffic control systems and procedures are included.

  2. The NSTX Trouble Reporting System

    International Nuclear Information System (INIS)

    Sengupta, S.; Oliaro, G.

    2002-01-01

    An online Trouble Reporting System (TRS) has been introduced at the National Spherical Torus Experiment (NSTX). The TRS is used by NSTX operators to report problems that affect NSTX operations. The purpose of the TRS is to enhance NSTX reliability and maintainability by identifying components, occurrences, and trends that contribute to machine downtime. All NSTX personnel have access to the TRS. The user interface is via a web browser, such as Netscape or Internet Explorer. This web-based feature permits any X-terminal, PC, or MAC access to the TRS. The TRS is based upon a trouble reporting system developed at the DIII-D Tokamak, at General Atomics Technologies. This paper will provide a detailed description of the TRS software architecture, user interface, MS SQL server interface and operational experiences. In addition, sample data from the TRS database will be summarized and presented

  3. Retrospective Study of Reported Adverse Events Due to Complementary Health Products in Singapore From 2010 to 2016

    Directory of Open Access Journals (Sweden)

    Yimin Xu

    2018-06-01

    Full Text Available The objective of this study is to collate and analyse adverse event reports associated with the use of complementary health products (CHP submitted to the Health Sciences Authority (HSA of Singapore for the period 2010–2016 to identify various trends and signals for pharmacovigilance purposes. A total of 147,215 adverse event reports suspected to be associated with pharmaceutical products and CHP were received by HSA between 2010 and 2016. Of these, 143,191 (97.3% were associated with chemical drugs, 1,807 (1.2% with vaccines, 1,324 (0.9% with biological drugs (biologics, and 893 (0.6% with CHP. The number of adverse event reports associated with Chinese Proprietary Medicine, other complementary medicine and health supplements are presented. Eight hundred and ninety three adverse event reports associated with CHP in the 7-year period have been successfully collated and analyzed. In agreement with other studies, adverse events related to the “skin and appendages disorders” were the most commonly reported. Most of the cases involved dermal allergies (e.g., rashes associated with the use of glucosamine products and most of the adulterated products were associated with the illegal addition of undeclared drugs for pain relief. Dexamethasone, chlorpheniramine, and piroxicam were the most common adulterants detected. Reporting suspected adverse events is strongly encouraged even if the causality is not confirmed because any signs of clustering will allow rapid regulatory actions to be taken. The findings from this study help to create greater awareness on the health risks, albeit low, when consuming CHP and dispelling the common misconception that “natural” means “safe.” In particular, healthcare professionals and the general public should be aware of potential adulteration of CHP. The analysis of spontaneously reported adverse events is an important surveillance system in monitoring the safety of CHP and helps in the understanding of the

  4. Extracting HEPs from Event Reports of Domestic Nuclear Power Plants-Case Study

    Energy Technology Data Exchange (ETDEWEB)

    Park, Jinkyun; Kim, Yochan; Jung, Wondea [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2016-10-15

    it is very important to soundly estimate the human error probability (HEP) of required tasks that could degrade the operational safety of systems. To this end, it is necessary to provide the HRA practitioners with the reliable catalog of HEPs. Unfortunately, one of the common issues raised by HRA practitioners is a lack of HRA data including HEPs. Therefore, many researchers are trying to provide reliable HRA data from diverse sources, such as (1) event reports reflecting the operational experience of domestic nuclear power plants (NPPs), and (2) human performance data observed from full- and/or partial-scope simulator exercises. It is evident that the contribution of human errors to the safety of socio-technical systems is very critical. For this reason, it is important for HRA practitioners to provide reliable HRA data including HEPs. Although a full-scope simulator can be used to collect valuable HRA data, it is still necessary to extract HRA data from the review of operational experience data. If so, it is possible to expect several benefits, such as the use of HRA data gathered from the operational experience of domestic NPPs as reference information to clarify the appropriateness of those collected from full-scope simulators.

  5. EVNTRE, Code System for Event Progression Analysis for PRA

    International Nuclear Information System (INIS)

    2002-01-01

    1 - Description of program or function: EVNTRE is a generalized event tree processor that was developed for use in probabilistic risk analysis of severe accident progressions for nuclear power plants. The general nature of EVNTRE makes it applicable to a wide variety of analyses that involve the investigation of a progression of events which lead to a large number of sets of conditions or scenarios. EVNTRE efficiently processes large, complex event trees. It can assign probabilities to event tree branch points in several different ways, classify pathways or outcomes into user-specified groupings, and sample input distributions of probabilities and parameters. PSTEVNT, a post-processor program used to sort and reclassify the 'binned' data output from EVNTRE and generate summary tables, is included. 2 - Methods: EVNTRE processes event trees that are cast in the form of questions or events, with multiple choice answers for each question. Split fractions (probabilities or frequencies that sum to unity) are either supplied or calculated for the branches of each question in a path-dependent manner. EVNTRE traverses the tree, enumerating the leaves of the tree and calculating their probabilities or frequencies based upon the initial probability or frequency and the split fractions for the branches taken along the corresponding path to an individual leaf. The questions in the event tree are usually grouped to address specific phases of time regimes in the progression of the scenario or severe accident. Grouping or binning of each path through the event tree in terms of a small number of characteristics or attributes is allowed. Boolean expressions of the branches taken are used to select the appropriate values of the characteristics of interest for the given path. Typically, the user specifies a cutoff tolerance for the frequency of a pathway to terminate further exploration. Multiple sets of input to an event tree can be processed by using Monte Carlo sampling to generate

  6. Events leading to foreign material being left in the primary heat transport system

    International Nuclear Information System (INIS)

    Groom, S.H.; Benton, A.J.

    1996-01-01

    On October 6,1995, following an extensive maintenance outage which had included boiler primary side cleaning, a Primary Heat Transport (PHT) system pump run was started in preparation for ultrasonic feeder flow measurements. Wooden debris in the system resulted in failure of the shaft seals of the PHT Pump 1. The subsequent investigation and assessment of this event provided an understanding of both the pump shaft failure mechanism and the origin of the debris in the PHT system. The pump shaft failed as a result of friction-generated heat resulting from contact between the rotating shaft and the stationary seal housing. This contact was initiated by mechanical and hydraulic imbalance in the pump impeller caused by wooden debris lodged in the impeller. The origin of the wooden debris was a temporary plywood cover which was inadvertently left in a boiler following maintenance. This cover moved from the boiler to the pump impeller when the PHT pumps were started. The cover was not accounted for and verified as being removed prior to boiler closure, although a visual inspection was conducted. A detailed institutional process for component accounting and verification of removal of materials did not exist at the time of this event. Details of the methods used to establish alternative heat sinks, provide debris recovery facilities and to assess the fitness for duty of the heat transport system and fuel channels prior to reactor startup are discussed in detail elsewhere. This report will concentrate on the events leading up to and following the events which ultimately resulted in failure of the PHT pump shaft

  7. Reliability of piping system components. Volume 4: The pipe failure event database

    Energy Technology Data Exchange (ETDEWEB)

    Nyman, R; Erixon, S [Swedish Nuclear Power Inspectorate, Stockholm (Sweden); Tomic, B [ENCONET Consulting GmbH, Vienna (Austria); Lydell, B [RSA Technologies, Visat, CA (United States)

    1996-07-01

    Available public and proprietary databases on piping system failures were searched for relevant information. Using a relational database to identify groupings of piping failure modes and failure mechanisms, together with insights from published PSAs, the project team determined why, how and where piping systems fail. This report represents a compendium of technical issues important to the analysis of pipe failure events, and statistical estimation of failure rates. Inadequacies of traditional PSA methodology are addressed, with directions for PSA methodology enhancements. A `data driven and systems oriented` analysis approach is proposed to enable assignment of unique identities to risk-significant piping system component failure. Sufficient operating experience does exist to generate quality data on piping failures. Passive component failures should be addressed by today`s PSAs to allow for aging analysis and effective, on-line risk management. 42 refs, 25 figs.

  8. Reliability of piping system components. Volume 4: The pipe failure event database

    International Nuclear Information System (INIS)

    Nyman, R.; Erixon, S.; Tomic, B.; Lydell, B.

    1996-07-01

    Available public and proprietary databases on piping system failures were searched for relevant information. Using a relational database to identify groupings of piping failure modes and failure mechanisms, together with insights from published PSAs, the project team determined why, how and where piping systems fail. This report represents a compendium of technical issues important to the analysis of pipe failure events, and statistical estimation of failure rates. Inadequacies of traditional PSA methodology are addressed, with directions for PSA methodology enhancements. A 'data driven and systems oriented' analysis approach is proposed to enable assignment of unique identities to risk-significant piping system component failure. Sufficient operating experience does exist to generate quality data on piping failures. Passive component failures should be addressed by today's PSAs to allow for aging analysis and effective, on-line risk management. 42 refs, 25 figs

  9. Report order and identification of multidimensional stimuli: a study of event-related brain potentials.

    Science.gov (United States)

    Shieh, Kong-King; Shen, I-Hsuan

    2004-06-01

    An experiment was conducted to investigate the effect of order of report on multidimensional stimulus identification. Subjects were required to identify each two-dimensional symbol by pushing corresponding buttons on the keypad on which there were two columns representing the two dimensions. Order of report was manipulated for the dimension represented by the left or right column. Both behavioral data and event-related potentials were recorded from 14 college students. Behavioral data analysis showed that order of report had a significant effect on response times. Such results were consistent with those of previous studies. Analysis of event-related brain potentials showed significant differences in peak amplitude and mean amplitude at time windows of 120-250 msec. at Fz, F3, and F4 and of 350-750 msec. at Fz, F3, F4, Cz, and Pz. Data provided neurophysiological evidence that reporting dimensional values according to natural language habits was appropriate and less cognitively demanding.

  10. Development and Initial Validation of a Patient-Reported Adverse Drug Event Questionnaire

    NARCIS (Netherlands)

    de Vries, Sieta T.; Mol, Peter G. M.; de Zeeuw, Dick; Haaijer-Ruskamp, Flora M.; Denig, Petra

    2013-01-01

    Background Direct patient reporting of adverse drug events (ADEs) is relevant for the evaluation of drug safety. To collect such data in clinical trials and postmarketing studies, a valid questionnaire is needed that can measure all possible ADEs experienced by patients. Objective Our aim was to

  11. Bad news: The influence of news coverage and Google searches on Gardasil adverse event reporting.

    Science.gov (United States)

    Faasse, Kate; Porsius, Jarry T; Faasse, Jonathan; Martin, Leslie R

    2017-12-14

    Human papilloma virus vaccines are a safe and effective tool for reducing HPV infections that can cause cervical cancer. However, uptake of these vaccines has been suboptimal, with many people holding negative beliefs and misconceptions. Such beliefs have been linked with the experience of unpleasant side effects following medical treatment, and media coverage may heighten such concerns. The present study sought to assess the influence of news coverage (number of news articles per month) on adverse event reporting in response to Gardasil vaccination in New Zealand over a 7.5-year period, and whether the influence of news coverage was mediated by internet search activity (Google search volumes). Multiple linear regression analyses and simple mediation analyses were used, controlling for year and number of vaccinations delivered. News coverage in the previous month, and Google search volumes in the same month, were significant predictors of adverse event reporting, after accounting for vaccination rates and year. Concurrent Google search volumes partially mediated the effect of prior news coverage. The results suggest that some of the adverse events reported were not related to the vaccination itself, but to news coverage and internet search volumes, which may have contributed to public concerns about potentially unpleasant or harmful outcomes. These findings have implications for the importance of psychological and social factors in adverse event reporting, and the role of the news media in disseminating health information. Copyright © 2017 Elsevier Ltd. All rights reserved.

  12. Adverse Events in the Netherlands Vaccination Programme : Reports in 2010 and Review 1994-2010

    NARCIS (Netherlands)

    Vermeer-de Bondt PE; Moorer-Lanser N; PHaff TAJ; Oostvogels B; Wesselo C; van der Maas NAT; LCI; cib

    2012-01-01

    In 2010, 800,000 children received one or more vaccines on 1.3 million dates, with more than 7 million vaccine components. There is always some chance of adverse reactions but these are usually not severe, though sometimes frightening. This year, RIVM received 1380 reports of adverse events

  13. 78 FR 41125 - Interim Enforcement Policy for Permanent Implant Brachytherapy Medical Event Reporting

    Science.gov (United States)

    2013-07-09

    ... NUCLEAR REGULATORY COMMISSION [NRC-2013-0114] Interim Enforcement Policy for Permanent Implant Brachytherapy Medical Event Reporting AGENCY: Nuclear Regulatory Commission. ACTION: Policy statement; revision. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing an interim Enforcement Policy that allows...

  14. 75 FR 16140 - Common Formats for Patient Safety Data Collection and Event Reporting

    Science.gov (United States)

    2010-03-31

    ... FR 45457-45458. Definition of Common Formats The term ``Common Formats'' is used to describe clinical... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Common Formats for Patient Safety Data Collection and Event Reporting AGENCY: Agency for Healthcare Research and...

  15. Procedures as a Contributing Factor to Events in the Swedish Nuclear Power Plants. Analysis of a Database with Licensee Event Reports 1995-1999

    International Nuclear Information System (INIS)

    Bento, Jean-Pierre

    2002-12-01

    departure from the mean values presented herein, indicating for these units a need for focussed corrective actions. Finally, this report exemplifies how the plant operating experience can be used for the definition of corrective actions based on the detailed analysis of MTO-related causes contributing to event recurrence and to latent weaknesses in safety functions, systems and components

  16. Mobile physician reporting of clinically significant events-a novel way to improve handoff communication and supervision of resident on call activities.

    Science.gov (United States)

    Nabors, Christopher; Peterson, Stephen J; Aronow, Wilbert S; Sule, Sachin; Mumtaz, Arif; Shah, Tushar; Eskridge, Etta; Wold, Eric; Stallings, Gary W; Burak, Kathleen Kelly; Goldberg, Randy; Guo, Gary; Sekhri, Arunabh; Mathew, George; Khera, Sahil; Montoya, Jessica; Sharma, Mala; Paudel, Rajiv; Frishman, William H

    2014-12-01

    Reporting of clinically significant events represents an important mechanism by which patient safety problems may be identified and corrected. However, time pressure and cumbersome report entry procedures have discouraged the full participation of physicians. To improve the process, our internal medicine training program developed an easy-to-use mobile platform that combines the reporting process with patient sign-out. Between August 25, 2011, and January 25, 2012, our trainees entered clinically significant events into i-touch/i-phone/i-pad based devices functioning in wireless-synchrony with our desktop application. Events were collected into daily reports that were sent from the handoff system to program leaders and attending physicians to plan for rounds and to correct safety problems. Using the mobile module, residents entered 31 reportable events per month versus the 12 events per month that were reported via desktop during a previous 6-month study period. Advances in information technology now permit clinically significant events that take place during "off hours" to be identified and reported (via handoff) to next providers and to supervisors via collated reports. This information permits hospital leaders to correct safety issues quickly and effectively, while attending physicians are able to use information gleaned from the reports to optimize rounding plans and to provide additional oversight of trainee on call patient management decisions.

  17. [Development of an index system for the comprehensive evaluation on public health emergency events surveillance system in China].

    Science.gov (United States)

    Hong, Zhiheng; Ni, Daxin; Cao, Yang; Meng, Ling; Tu, Wenxiao; Li, Leilei; Li, Qun; Jin, Lianmei

    2015-06-01

    To establish a comprehensive evaluation index system for the China Public Health Emergency Events Surveillance System (CPHEESS). A draft index system was built through literature review and under the consideration of the characteristics on CPHEESS. Delphi method was adapted to determine the final index system. The index system was divided into primary, secondary and tertiary levels. There were 4 primary indicators: System structure, Network platform, Surveillance implementation reports with Data analysis and utilization. There were 16 secondary and 70 tertiary indicators being set, with System structure including 14 tertiary indicators (accounted for 20.00%), 21 Network platforms (accounted for 30.00%). Twenty-four Surveillance implementation reports (accounted for 34.29%), 11 Data analysis and utilization (accounted for 15.71%). The average score of importance of each indicators was 4.29 (3.77-4.94), with an average coefficient variation as 0.14 (0.12-0.16). The mean Chronbach's α index was 0.84 (0.81-0.89). The adaptability of each related facilities indicator was specified. The primary indicators were set in accordance with the characteristics and goals of the surveillance systems. Secondary indicators provided key elements in the management and control of the system while the tertiary indicators were available and operative. The agreement rate of experts was high with good validity and reliability. This index system could be used for CPHEESS in future.

  18. Event Processing and Variable Part of Sample Period Determining in Combined Systems Using GA

    Science.gov (United States)

    Strémy, Maximilián; Závacký, Pavol; Jedlička, Martin

    2011-01-01

    This article deals with combined dynamic systems and usage of modern techniques in dealing with these systems, focusing particularly on sampling period design, cyclic processing tasks and related processing algorithms in the combined event management systems using genetic algorithms.

  19. 'Case reporting of rare adverse events in otolaryngology': can we defend the case report?

    LENUS (Irish Health Repository)

    Dias, Andrew

    2012-01-31

    The study of errors in medicine has proliferated since the publication of The Institute of Medicine Report \\'TO ERR IS HUMAN\\' in 2000. Case nuances and process of care issues are valuable areas to explore if the goal is to provide the health care worker with the knowledge to avoid future errors. Meta-analysis and randomized controlled trials provide a large data base of evidence towards improvement and opportunities, but it is suggested that case reports can still provide valuable clinical information. The aim is to use the published literature to produce a series of rare harm case reports in E.N.T. The methods include systematic literature review. Journals searched in PUBMED were 60. Rare harm case obtained from the search were 5,322. Rare harm case reports not reported in any other form of evidence-based medicine were 40. Yes, the case report can be defended as it is an important pillar of evidence-based medicine.

  20. Making systems with mutually exclusive events analysable by standard fault tree analysis tools

    International Nuclear Information System (INIS)

    Vaurio, J.K.

    2001-01-01

    Methods are developed for analysing systems that comprise mutually exclusive events by fault tree techniques that accept only statistically independent basic events. Techniques based on equivalent models and numerical transformations are presented for phased missions and for systems with component-caused system-level common cause failures. Numerical examples illustrate the methods

  1. A Numerical Approach for Hybrid Simulation of Power System Dynamics Considering Extreme Icing Events

    DEFF Research Database (Denmark)

    Chen, Lizheng; Zhang, Hengxu; Wu, Qiuwei

    2017-01-01

    numerical simulation scheme integrating icing weather events with power system dynamics is proposed to extend power system numerical simulation. A technique is developed to efficiently simulate the interaction of slow dynamics of weather events and fast dynamics of power systems. An extended package for PSS...

  2. Is thermodynamics of the universe bounded by event horizon a Bekenstein system?

    International Nuclear Information System (INIS)

    Chakraborty, Subenoy

    2012-01-01

    In this brief communication, we have studied the validity of the first law of thermodynamics for the universe bounded by event horizon with two examples. The key point is the appropriate choice of the temperature on the event horizon. Finally, we have concluded that universe bounded by the event horizon may be a Bekenstein system and Einstein's equations and the first law of thermodynamics on the event horizons are equivalent.

  3. Is thermodynamics of the universe bounded by event horizon a Bekenstein system?

    OpenAIRE

    Chakraborty, Subenoy

    2012-01-01

    In this brief communication, we have studied the validity of the first law of thermodynamics for the universe bounded by event horizon with two examples. The key point is the appropriate choice of the temperature on the event horizon. Finally, we have concluded that universe bounded by the event horizon may be a Bekenstein system and the Einstein's equations and the first law of thermodynamics on the event horizons are equivalent.

  4. Case Report of Multiembolic Cerebrovascular Event Associated with Ramp Study Echocardiogram

    Directory of Open Access Journals (Sweden)

    Brian C. Butera

    2017-01-01

    Full Text Available The incidence of ramp test echocardiogram-associated embolic events in the setting of therapeutic anticoagulation is likely rare and has not been reported. We present such a case in a patient with a HeartMate II left ventricular assist device (LVAD whose serial head computed tomography images, deteriorating clinical course, and the multiembolic nature of the event suggest causality. If the pretest probability of pump thrombosis in an individual LVAD patient is sufficiently high, the potential risks of performing a ramp study echocardiogram may not be warranted, even in the setting of adequate anticoagulation.

  5. World wide web for database of Japanese translation on international nuclear event scale reports

    International Nuclear Information System (INIS)

    Watanabe, Norio; Hirano, Masashi

    1999-01-01

    The International Nuclear Event Scale (INES) is a means designed for providing prompt, clear and consistent information related to nuclear events, that occurred at nuclear facilities, and facilitating communication between the nuclear community, the media and the public. The INES is jointly operated by the IAEA and the OECD-NEA. Nuclear events reported are rated by the Scale', a consistent safety significance indicator. The scale runs from level 0, for events with no safety significance, to level 7 for a major accident with widespread health and environmental effects. The Japan Atomic Energy Research Institute (JAERI) has been promptly translating the INES reports into Japanese and developing a world-wide-web database for the Japanese translation, aiming at more efficient utilization of the INES information inside Japan. The present paper briefly introduces the definitions of INES rating levels and the scope of the Scale, and describes the outlines of the database (the information stored in the database, its functions and how to use it). As well, technical use of the INES reports and the availability/ effectiveness of the database are discussed. (author)

  6. A large-scale dataset of solar event reports from automated feature recognition modules

    Science.gov (United States)

    Schuh, Michael A.; Angryk, Rafal A.; Martens, Petrus C.

    2016-05-01

    The massive repository of images of the Sun captured by the Solar Dynamics Observatory (SDO) mission has ushered in the era of Big Data for Solar Physics. In this work, we investigate the entire public collection of events reported to the Heliophysics Event Knowledgebase (HEK) from automated solar feature recognition modules operated by the SDO Feature Finding Team (FFT). With the SDO mission recently surpassing five years of operations, and over 280,000 event reports for seven types of solar phenomena, we present the broadest and most comprehensive large-scale dataset of the SDO FFT modules to date. We also present numerous statistics on these modules, providing valuable contextual information for better understanding and validating of the individual event reports and the entire dataset as a whole. After extensive data cleaning through exploratory data analysis, we highlight several opportunities for knowledge discovery from data (KDD). Through these important prerequisite analyses presented here, the results of KDD from Solar Big Data will be overall more reliable and better understood. As the SDO mission remains operational over the coming years, these datasets will continue to grow in size and value. Future versions of this dataset will be analyzed in the general framework established in this work and maintained publicly online for easy access by the community.

  7. Act to keep patients safe: device-related adverse event reporting.

    Science.gov (United States)

    Schoem, Scott R; Shah, Udayan K

    2010-05-01

    Primum non nocere- "Above all do no harm." Since the first year of medical school, we have all heard and spoken this dictum countless times. Translating this dictum into action may present challenges in our daily practice. Every day, clinicians must distinguish between scientific evidence, clinical experience, and marketing claims by industry vendors of improved efficacy and safety regarding medical devices. Adverse event reporting and device failure notification are generally laid out well in hospital practice settings. Reporting beyond the local level takes on a new dimension for most surgeons. Perceived stigma from peers and corporations, lack of confidentiality, and cynicism regarding protective actions for patients should not limit one from "raising the alarm" when concerns arise about device safety or performance. This commentary aims to explain the process for reporting device-related adverse events. Copyright 2010 American Academy of Otolaryngology-Head and Neck Surgery Foundation. Published by Mosby, Inc. All rights reserved.

  8. Establishment of nuclear knowledge and information infrastructure; establishment of web-based database system for nuclear events

    Energy Technology Data Exchange (ETDEWEB)

    Park, W. J.; Kim, K. J. [Korea Atomic Energy Research Institute , Taejeon (Korea); Lee, S. H. [Korea Institute of Nuclear Safety, Taejeon (Korea)

    2001-05-01

    Nuclear events data reported by nuclear power plants are useful to prevent nuclear accidents at the power plant by examine the cause of initiating events and removal of weak points in the aspects of operational safety, and to improve nuclear safety in design and operation stages by backfitting operational experiences and practices 'Nuclear Event Evaluation Database : NEED' system distributed by CD-ROM media are upgraded to the NEED-Web (Web-based Nuclear Event Evaluation Database) version to manage event data using database system on network basis and the event data and the statistics are provided to the authorized users in the Nuclear Portal Site and publics through Internet Web services. The efforts to establish the NEED-Web system will improve the integrity of events data occurred in Korean nuclear power plant and the usability of data services, and enhance the confidence building and the transparency to the public in nuclear safety. 11 refs., 27 figs. (Author)

  9. An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions

    DEFF Research Database (Denmark)

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne

    2017-01-01

    INTRODUCTION: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region......%). The drugs most frequently reported were lisdexamphetamine (n = 40), rivaroxaban (n = 16) and warfarin (n = 15) (vaccines excluded). In 13 out of 484 reports, the ADR was associated with a fatal outcome. CONCLUSION: The findings of this study indicate that an ADEM promotes and facilitates spontaneous ADR...

  10. Department of Defense Suicide Event Report (DoDSER) Calendar Year 2014 Annual Report

    Science.gov (United States)

    2015-07-16

    diagnoses identified in suicide DoDSER reports included mood (n= 17, 28.3%), adjustment (n = 14, 23.3%) and anxiety (n = 13, 21.7%) disorders . For suicide ...n = 35, 27.3%) and substance abuse (n = 35, 27.3%) disorders . For suicide attempt DoDSER reports, the most common diagnoses identified were mood (n...diagnoses identified in suicide DoDSER reports included mood (n= 10, 17.2%), adjustment (n = 8, 13.8%) and substance abuse (n = 8, 13.8%) disorders . For

  11. Second-Order Multiagent Systems with Event-Driven Consensus Control

    Directory of Open Access Journals (Sweden)

    Jiangping Hu

    2013-01-01

    Full Text Available Event-driven control scheduling strategies for multiagent systems play a key role in future use of embedded microprocessors of limited resources that gather information and actuate the agent control updates. In this paper, a distributed event-driven consensus problem is considered for a multi-agent system with second-order dynamics. Firstly, two kinds of event-driven control laws are, respectively, designed for both leaderless and leader-follower systems. Then, the input-to-state stability of the closed-loop multi-agent system with the proposed event-driven consensus control is analyzed and the bound of the inter-event times is ensured. Finally, some numerical examples are presented to validate the proposed event-driven consensus control.

  12. Serious reportable events within the inpatient mental health care: Impact on physicians and nurses.

    Science.gov (United States)

    Martens, J; Van Gerven, E; Lannoy, K; Panella, M; Euwema, M; Sermeus, W; De Hert, M; Vanhaecht, K

    2016-07-01

    To investigate the prevalence of physicians and nurses involved in an adverse event within mental health. A quantitative, cross-sectional study was performed. Six Flemish psychiatric hospitals (Belgium) participated in this exploratory cross-sectional study. All psychiatrists and nurses working in these hospitals were invited to complete an online questionnaire in March 2013. 28 psychiatrists and 252 nurses completed the survey. 205 (73%) of the 280 respondents were personally involved at least once in an adverse event within their entire career. Respondents reported that the adverse event with the greatest impact was related to suicide in almost 64% of the cases. About one in eight respondents considered quitting their job because of it. Almost 18% declared that due to the impact of the event, they believed that the quality of the administered care was affected for longer than one month. Respondents stated that they received much support of colleagues (95%), the chief nurse (86%) and the partner (71%). Colleagues seemed to be most supportive in the recovery process. Physicians and nurses working in inpatient mental health care may be at high risk to being confronted with an adverse event at some point in their career. The influence on health professionals involved in an adverse event on their work is particularly important in the first 4-24h. Professionals at those moments had higher likelihood to be involved in another adverse event. Institutions should seriously consider giving support almost at that time. Copyright © 2016 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  13. Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting

    Directory of Open Access Journals (Sweden)

    Philipp Bruland

    2016-11-01

    Full Text Available Abstract Background Data capture is one of the most expensive phases during the conduct of a clinical trial and the increasing use of electronic health records (EHR offers significant savings to clinical research. To facilitate these secondary uses of routinely collected patient data, it is beneficial to know what data elements are captured in clinical trials. Therefore our aim here is to determine the most commonly used data elements in clinical trials and their availability in hospital EHR systems. Methods Case report forms for 23 clinical trials in differing disease areas were analyzed. Through an iterative and consensus-based process of medical informatics professionals from academia and trial experts from the European pharmaceutical industry, data elements were compiled for all disease areas and with special focus on the reporting of adverse events. Afterwards, data elements were identified and statistics acquired from hospital sites providing data to the EHR4CR project. Results The analysis identified 133 unique data elements. Fifty elements were congruent with a published data inventory for patient recruitment and 83 new elements were identified for clinical trial execution, including adverse event reporting. Demographic and laboratory elements lead the list of available elements in hospitals EHR systems. For the reporting of serious adverse events only very few elements could be identified in the patient records. Conclusions Common data elements in clinical trials have been identified and their availability in hospital systems elucidated. Several elements, often those related to reimbursement, are frequently available whereas more specialized elements are ranked at the bottom of the data inventory list. Hospitals that want to obtain the benefits of reusing data for research from their EHR are now able to prioritize their efforts based on this common data element list.

  14. Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting.

    Science.gov (United States)

    Bruland, Philipp; McGilchrist, Mark; Zapletal, Eric; Acosta, Dionisio; Proeve, Johann; Askin, Scott; Ganslandt, Thomas; Doods, Justin; Dugas, Martin

    2016-11-22

    Data capture is one of the most expensive phases during the conduct of a clinical trial and the increasing use of electronic health records (EHR) offers significant savings to clinical research. To facilitate these secondary uses of routinely collected patient data, it is beneficial to know what data elements are captured in clinical trials. Therefore our aim here is to determine the most commonly used data elements in clinical trials and their availability in hospital EHR systems. Case report forms for 23 clinical trials in differing disease areas were analyzed. Through an iterative and consensus-based process of medical informatics professionals from academia and trial experts from the European pharmaceutical industry, data elements were compiled for all disease areas and with special focus on the reporting of adverse events. Afterwards, data elements were identified and statistics acquired from hospital sites providing data to the EHR4CR project. The analysis identified 133 unique data elements. Fifty elements were congruent with a published data inventory for patient recruitment and 83 new elements were identified for clinical trial execution, including adverse event reporting. Demographic and laboratory elements lead the list of available elements in hospitals EHR systems. For the reporting of serious adverse events only very few elements could be identified in the patient records. Common data elements in clinical trials have been identified and their availability in hospital systems elucidated. Several elements, often those related to reimbursement, are frequently available whereas more specialized elements are ranked at the bottom of the data inventory list. Hospitals that want to obtain the benefits of reusing data for research from their EHR are now able to prioritize their efforts based on this common data element list.

  15. Network based on statistical multiplexing for event selection and event builder systems in high energy physics experiments

    International Nuclear Information System (INIS)

    Calvet, D.

    2000-03-01

    Systems for on-line event selection in future high energy physics experiments will use advanced distributed computing techniques and will need high speed networks. After a brief description of projects at the Large Hadron Collider, the architectures initially proposed for the Trigger and Data AcQuisition (TD/DAQ) systems of ATLAS and CMS experiments are presented and analyzed. A new architecture for the ATLAS T/DAQ is introduced. Candidate network technologies for this system are described. This thesis focuses on ATM. A variety of network structures and topologies suited to partial and full event building are investigated. The need for efficient networking is shown. Optimization techniques for high speed messaging and their implementation on ATM components are described. Small scale demonstrator systems consisting of up to 48 computers (∼1:20 of the final level 2 trigger) connected via ATM are described. Performance results are presented. Extrapolation of measurements and evaluation of needs lead to a proposal of implementation for the main network of the ATLAS T/DAQ system. (author)

  16. Clinical events in coronary patients who report low distress: adverse effect of repressive coping.

    Science.gov (United States)

    Denollet, Johan; Martens, Elisabeth J; Nyklícek, Ivan; Conraads, Viviane M; de Gelder, Beatrice

    2008-05-01

    Coronary artery disease (CAD) patients who report low distress are considered to be at low psychological risk for clinical events. However, patients with a repressive coping style may fail to detect and report signals of emotional distress. The authors hypothesized that repressive CAD patients are at risk for clinical events, despite low self-rated distress. This was a prospective 5- to 10-year follow-up study, with a mean follow-up of 6.6 years. At baseline, 731 CAD patients filled out Trait-Anxiety (distress), Marlowe-Crowne (defensiveness), and Type D scales; 159 patients were classified as "repressive," 360 as "nonrepressive," and 212 as "Type D." The primary endpoint was a composite of total mortality or myocardial infarction (MI); the secondary endpoint was cardiac mortality/MI. No patients were lost to follow-up; 91 patients had a clinical event (including 35 cardiac death and 32 MI). Repressive patients reported low levels of anxiety, anger and depression at baseline, but were at increased risk for death/MI (21/159 = 13%) compared with nonrepressive patients (22/360 = 6%), p = .009. Poor systolic function, poor exercise tolerance, 3-vessel disease, index MI and Type-D personality--but not depression, anxiety or anger--also independently predicted clinical events. After controlling for these variables, repressive patients still had a twofold increased risk of death/MI, OR = 2.17, 95% CI = 1.10-4.08, p = .025). These findings were replicated for cardiac mortality/MI. CAD patients who use a repressive coping style are at increased risk for clinical events, despite their claims of low emotional distress. This phenomenon may cause an underestimation of the effect of stress on the heart. (PsycINFO Database Record (c) 2008 APA, all rights reserved).

  17. Journalists' Occupational Stress: A Comparative Study between Reporting Critical Events and Domestic News.

    Science.gov (United States)

    Monteiro, Susana; Marques-Pinto, Alexandra

    2017-07-27

    Nowadays, journalism is considered a stressful occupation, not only due to the stress perceived in journalists' daily work but also due to the critical, potentially traumatic events they report. However, research on journalists' occupational stress in both these professional settings is still scarce. This study aims to characterize and compare occupational stress variables perceived by journalists in their daily work and in critical scenarios. Taking the Holistic Model of Occupational Stress by Nelson and Simmons (2003) as a framework, 25 Portuguese journalists, all with experience in reporting critical events, were interviewed on their perceptions of some core variables of the model: occupational stressors, distress and eustress emotional reactions, and the consequences of these experiences on their well-being. Differences among these core variables, according to the number of deployments to a critical event, were statistically analysed in order to ascertain whether repeated exposure to trauma influenced journalists' occupational stress perceptions. The data content analysis showed that occupational stressors and emotional reactions differed across settings, while the consequences associated with journalists' experiences were perceived as being mainly negative in both occupational contexts. Significant differences were identified in some of these variables according to the number of deployments to a critical event (p studies.

  18. Development of an adverse events reporting form for Korean folk medicine.

    Science.gov (United States)

    Park, Jeong Hwan; Choi, Sun-Mi; Moon, Sujeong; Kim, Sungha; Kim, Boyoung; Kim, Min-Kyeoung; Lee, Sanghun

    2017-05-01

    We developed an adverse events (AEs) reporting form for Korean folk medicine. The first version of the form was developed and tested in the clinical setting for spontaneous reporting of AEs. Additional revisions to the reporting form were made based on collected data and expert input. We developed an AEs reporting form for Korean folk medicine. The items of this form were based on patient information, folk medicine properties, and AEs. For causality assessment, folk medicine properties such as classification, common and vernacular names, scientific name, part used, harvesting time, storage conditions, purchasing route, product licensing, prescription, persons with similar exposure, any remnant of raw natural products collected from the patient, and cautions or contraindications were added. This is the first reporting form for AEs that incorporates important characteristics of Korean folk medicine. This form would have an important role in reporting adverse events for Korean folk medicine. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

  19. Control of discrete-event systems with modular or distributed structure

    Czech Academy of Sciences Publication Activity Database

    Komenda, Jan; van Schuppen, J. H.

    2007-01-01

    Roč. 388, č. 3 (2007), s. 199-226 ISSN 0304-3975 R&D Projects: GA AV ČR(CZ) KJB100190609 Institutional research plan: CEZ:AV0Z10190503 Keywords : supervisory control * modular discrete-event system * distributed discrete-event system Subject RIV: BA - General Mathematics Impact factor: 0.735, year: 2007

  20. Evaluation of corrective action data for reportable events at commercial nuclear power plants

    International Nuclear Information System (INIS)

    Mays, G.T.

    1991-01-01

    805The Nuclear Regulatory Commission (NRC) approved the adoption of cause codes for reportable events as a new performance indicator (PI) in March 1989. Corrective action data associated with the causes of events were to be compiled also. The corrective action data was considered as supplemental information but not identified formally as a performance indicator. In support of NRC, the Nuclear Operations Analysis Center (NOAC) at the Oak Ridge National Laboratory (ORNL) has been routinely evaluating licensee event reports (LERs) for cause code and corrective action data since 1989. The compilation of corrective action data by NOAC represents the first systematic and comprehensive compilation of this type data. The thrust of analyzing the corrective action data was to identify areas where licensees allocated resources to solve problems and prevent the recurrence of personnel errors and equipment failures. The predominant areas of corrective action reported by licensees are to be evaluated by NRC to compare with NRC programs designed to improve plant performance. The set of corrective action codes used to correlate with individual cause codes and included in the analyses were: training, procedural modification, corrective discipline, management change, design modification, equipment replacement/adjustment, other, and unknown. 1 fig

  1. A critical incident reporting system in anaesthesia.

    Science.gov (United States)

    Madzimbamuto, F D; Chiware, R

    2001-01-01

    To audit the recently established Critical Incident Reporting System in the Department of Anaesthesia and Critical Care Medicine, University of Zimbabwe Medical School. The system was set up with the purpose of improving the quality of care delivered by the department. Cross sectional study. A critical incident was defined as 'any adverse and reversible event in theatre, during or immediately after surgery that if it persisted without correction would cause harm to the patient'. The anaesthetic or recovery room staff filled a critical incident form anonymously. Data was collected from critical incident reporting forms for analysis. The anaesthetic service in the two teaching hospitals of Harare Central and Parirenyatwa General Hospitals. Between May and October 2000, 62 completed critical incident forms were collected. The nature of the incident and the monitoring used were recorded, the cause was classified as human, equipment or monitoring failure and the outcome for each patient reported. There was no formal system for reminding staff to fill in their critical incident forms. A total of 14,165 operations were performed over the reporting period: 62 critical incident forms were collected, reporting 130 incidents, giving a rate of 0.92% (130/14,165). Of these, 42 patients were emergencies and 20 elective. The incidents were hypotension, hypoxia, bradycardia, ECG changes, aspiration, laryngospasm, high spinal, and cardiac arrest. Monitoring present on patients who had critical incidents was: capnography 57%, oxymetry 90% and ECG 100%. Other monitors are not reported. Human error contributed in 32/62 of patients and equipment failure in 31/62 of patients. Patient outcome showed 15% died, 23% were unplanned admissions to HDU while 62% were discharged to the ward with little or no adverse outcome. Despite some under reporting, the critical incident rate was within the range reported in the literature. Supervision of juniors is not adequate, especially on call. The

  2. Latency and mode of error detection as reflected in Swedish licensee event reports

    Energy Technology Data Exchange (ETDEWEB)

    Svenson, Ola; Salo, Ilkka [Stockholm Univ., (Sweden). Dept. of Psychology

    2002-03-01

    Licensee event reports (LERs) from an industry provide important information feedback about safety to the industry itself, the regulators and to the public. LERs from four nuclear power reactors were analyzed to find out about detection times, mode of detection and qualitative differences in reports from different reactors. The reliability of the coding was satisfactory and measured as the covariance between the ratings from two independent judges. The results showed differences in detection time across the reactors. On the average about ten percent of the errors remained undetected for 100 weeks or more, but the great majority of errors were detected soon after their first appearance in the plant. On the average 40 percent of the errors were detected in regular tests and 40 per cent through alarms. Operators found about 10 per cent of the errors through noticing something abnormal in the plant. The remaining errors were detected in various other ways. There were qualitative differences between the LERs from the different reactors reflecting the different conditions in the plants. The number of reports differed by a magnitude 1:2 between the different plants. However, a greater number of LERs can indicate both higher safety standards (e.g., a greater willingness to report all possible events to be able to learn from them) and lower safety standards (e.g., reporting as few events as possible to make a good impression). It was pointed out that LERs are indispensable in order to maintain safety of an industry and that the differences between plants found in the analyses of this study indicate how error reports can be used to initiate further investigations for improved safety.

  3. Latency and mode of error detection as reflected in Swedish licensee event reports

    International Nuclear Information System (INIS)

    Svenson, Ola; Salo, Ilkka

    2002-03-01

    Licensee event reports (LERs) from an industry provide important information feedback about safety to the industry itself, the regulators and to the public. LERs from four nuclear power reactors were analyzed to find out about detection times, mode of detection and qualitative differences in reports from different reactors. The reliability of the coding was satisfactory and measured as the covariance between the ratings from two independent judges. The results showed differences in detection time across the reactors. On the average about ten percent of the errors remained undetected for 100 weeks or more, but the great majority of errors were detected soon after their first appearance in the plant. On the average 40 percent of the errors were detected in regular tests and 40 per cent through alarms. Operators found about 10 per cent of the errors through noticing something abnormal in the plant. The remaining errors were detected in various other ways. There were qualitative differences between the LERs from the different reactors reflecting the different conditions in the plants. The number of reports differed by a magnitude 1:2 between the different plants. However, a greater number of LERs can indicate both higher safety standards (e.g., a greater willingness to report all possible events to be able to learn from them) and lower safety standards (e.g., reporting as few events as possible to make a good impression). It was pointed out that LERs are indispensable in order to maintain safety of an industry and that the differences between plants found in the analyses of this study indicate how error reports can be used to initiate further investigations for improved safety

  4. Enhancing the Effectiveness of Significant Event Analysis: Exploring Personal Impact and Applying Systems Thinking in Primary Care.

    Science.gov (United States)

    Bowie, Paul; McNaughton, Elaine; Bruce, David; Holly, Deirdre; Forrest, Eleanor; Macleod, Marion; Kennedy, Susan; Power, Ailsa; Toppin, Denis; Black, Irene; Pooley, Janet; Taylor, Audrey; Swanson, Vivien; Kelly, Moya; Ferguson, Julie; Stirling, Suzanne; Wakeling, Judy; Inglis, Angela; McKay, John; Sargeant, Joan

    2016-01-01

    Significant event analysis (SEA) is well established in many primary care settings but can be poorly implemented. Reasons include the emotional impact on clinicians and limited knowledge of systems thinking in establishing why events happen and formulating improvements. To enhance SEA effectiveness, we developed and tested "guiding tools" based on human factors principles. Mixed-methods development of guiding tools (Personal Booklet-to help with emotional demands and apply a human factors analysis at the individual level; Desk Pad-to guide a team-based systems analysis; and a written Report Format) by a multiprofessional "expert" group and testing with Scottish primary care practitioners who submitted completed enhanced SEA reports. Evaluation data were collected through questionnaire, telephone interviews, and thematic analysis of SEA reports. Overall, 149/240 care practitioners tested the guiding tools and submitted completed SEA reports (62.1%). Reported understanding of how to undertake SEA improved postintervention (P systems issues (85/123, 69.1%), while most found the Report Format clear (94/123, 76.4%) and would recommend it (88/123, 71.5%). Most SEA reports adopted a systems approach to analyses (125/149, 83.9%), care improvement (74/149, 49.7), or planned actions (42/149, 28.2%). Applying human factors principles to SEA potentially enables care teams to gain a systems-based understanding of why things go wrong, which may help with related emotional demands and with more effective learning and improvement.

  5. Synthesis report: System studies Bioenergy

    International Nuclear Information System (INIS)

    Berntsson, Thore

    2003-01-01

    The present report marks the end of the research program 'System studies Bioenergy' (1998-2002). The program comprised 17 projects performed at 9 universities or research institutes. All project results were studied in order to identify: contributions to our present knowledge; possible gaps of knowledge, methodology or systems perspective that still exist; and the needs for further research. The projects can be classified into the following groups: Resource potential of forest fuels; Industrial use of biofuels; Potential for synthetic fuels (pellets, bio-oils and transportation fuels); System analysis of efficient use of biofuels; and Socio-economic analyses. The total potential for available biofuel has been estimated to be 125-175 TWh/year (excl. black liquors of paper industry). The potential demand is estimated to about 123 TWh/year, or distributed into the different sectors: Industry: 26 TWh/year, Buildings and services: 35 TWh/year, District heating: 31 TWh/year, and electric power generation (incl. cogeneration in district heating): 31 TWh/year. Further research is needed in the following areas: Systems and methodology of more generic character on optimization of production, refining and use of biofuels in order to substitute fossil fuels directly or indirectly; Heat sinks/district heating in combination with cogeneration vs. other power production in a long term perspective (> 10 years), in the light of new technologies, open markets, economic and political incentives; Energy efficiency in industry, esp. paper and pulp with its unique possibility for process integration, biofuel processing and CO 2 separation; How far should the processing/refinement of biofuels go; Importance of factors of scale; New distributed (small-scale) energy technology; International trade in biofuels; Transport and handling costs for biofuel pellets in Europe; System aspects of implementation and incentives; How are biofuels affected if CO 2 from fossil fuels can be separated and

  6. French power system reliability report 2008

    International Nuclear Information System (INIS)

    Tesseron, J.M.

    2009-06-01

    The reliability of the French power system was fully under control in 2008, despite the power outage in the eastern part of the Provence-Alpes-Cote d'Azur region on November 3, which had been dreaded for several years, since it had not been possible to set up a structurally adequate network. Pursuant to a consultation meeting, the reinforcement solution proposed by RTE was approved by the Minister of Energy, boding well for greater reliability in future. Based on the observations presented in this 2008 Report, RTE's Power System Reliability Audit Mission considers that no new recommendations are needed beyond those expressed in previous reliability reports and during reliability audits. The publication of this yearly report is in keeping with RTE's goal to promote the follow-up over time of the evolution of reliability in its various aspects. RTE thus aims to contribute to the development of reliability culture, by encouraging an improved assessment by the different players (both RTE and network users) of the role they play in building reliability, and by advocating the taking into account of reliability and benchmarking in the European organisations of Transmission System Operators. Contents: 1 - Brief overview of the evolution of the internal and external environment; 2 - Operating situations encountered: climatic conditions, supply / demand balance management, operation of interconnections, management of internal congestion, contingencies affecting the transmission facilities; 3 - Evolution of the reliability reference guide: external reference guide: directives, laws, decrees, etc, ETSO, UCTE, ENTSO-E, contracting contributing to reliability, RTE internal reference guide; 4 - Evolution of measures contributing to reliability in the equipment field: intrinsic performances of components (generating sets, protection systems, operation PLC's, instrumentation and control, automatic frequency and voltage controls, transmission facilities, control systems, load

  7. Analyzing System on A Chip Single Event Upset Responses using Single Event Upset Data, Classical Reliability Models, and Space Environment Data

    Science.gov (United States)

    Berg, Melanie; LaBel, Kenneth; Campola, Michael; Xapsos, Michael

    2017-01-01

    We are investigating the application of classical reliability performance metrics combined with standard single event upset (SEU) analysis data. We expect to relate SEU behavior to system performance requirements. Our proposed methodology will provide better prediction of SEU responses in harsh radiation environments with confidence metrics. single event upset (SEU), single event effect (SEE), field programmable gate array devises (FPGAs)

  8. Event maps in a stick-slip system

    DEFF Research Database (Denmark)

    Galvanetto, Ugo; Knudsen, Carsten

    1997-01-01

    This paper describes a one-dimensional map generated by a two degree-of-freedom mechanical system that undergoes self-sustained oscillations induced by dry friction. The iterated map allows a much simpler representation and a better understanding of some dynamic features of the system. Some appli...

  9. Auditing an Online Self-reported Interventional Radiology Adverse Event Database for Compliance and Accuracy.

    Science.gov (United States)

    Burch, Ezra A; Shyn, Paul B; Chick, Jeffrey F; Chauhan, Nikunj R

    2017-04-01

    The purpose of this study was to determine whether auditing an online self-reported interventional radiology quality assurance database improves compliance with record entry or improves the accuracy of adverse event (AE) reporting and grading. Physicians were trained in using the database before the study began. An audit of all database entries for the first 3 months, or the first quarter, was performed, at which point physicians were informed of the audit process; entries for the subsequent 3 months, or the second quarter, were again audited. Results between quarters were compared. Compliance with record entry improved from the first to second quarter, but reminders were necessary to ensure 100% compliance with record entry. Knowledge of the audit process did not significantly improve self-reporting of AE or accuracy of AE grading. However, auditing significantly changed the final AE reporting rates and grades. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  10. An evaluation of selected herbal reference texts and comparison to published reports of adverse herbal events.

    Science.gov (United States)

    Haller, Christine A; Anderson, Ilene B; Kim, Susan Y; Blanc, Paul D

    2002-01-01

    There has been a recent proliferation of medical reference texts intended to guide practitioners whose patients use herbal therapies. We systematically assessed six herbal reference texts to evaluate the information they contain on herbal toxicity. We selected six major herbal references published from 1996 to 2000 to evaluate the adequacy of their toxicological information in light of published adverse events. To identify herbs most relevant to toxicology, we reviewed herbal-related calls to our regional California Poison Control System, San Francisco division (CPCS-SF) in 1998 and identified the 12 herbs (defined as botanical dietary supplements) most frequently involved in these CPCS-SF referrals. We searched Medline (1966 to 2000) to identify published reports of adverse effects potentially related to these same 12 herbs. We scored each herbal reference text on the basis of information inclusiveness for the target 12 herbs, with a maximal overall score of 3. The herbs, identified on the basis of CPCS-SF call frequency were: St John's wort, ma huang, echinacea, guarana, ginkgo, ginseng, valerian, tea tree oil, goldenseal, arnica, yohimbe and kava kava. The overall herbal reference scores ranged from 2.2 to 0.4 (median 1.1). The Natural Medicines Comprehensive Database received the highest overall score and was the most complete and useful reference source. All of the references, however, lacked sufficient information on management of herbal medicine overdose, and several had incorrect overdose management guidelines that could negatively impact patient care. Current herbal reference texts do not contain sufficient information for the assessment and management of adverse health effects of botanical therapies.

  11. Impacts of European drought events: insights from an international database of text-based reports

    Science.gov (United States)

    Stahl, Kerstin; Kohn, Irene; Blauhut, Veit; Urquijo, Julia; De Stefano, Lucia; Acácio, Vanda; Dias, Susana; Stagge, James H.; Tallaksen, Lena M.; Kampragou, Eleni; Van Loon, Anne F.; Barker, Lucy J.; Melsen, Lieke A.; Bifulco, Carlo; Musolino, Dario; de Carli, Alessandro; Massarutto, Antonio; Assimacopoulos, Dionysis; Van Lanen, Henny A. J.

    2016-03-01

    Drought is a natural hazard that can cause a wide range of impacts affecting the environment, society, and the economy. Providing an impact assessment and reducing vulnerability to these impacts for regions beyond the local scale, spanning political and sectoral boundaries, requires systematic and detailed data regarding impacts. This study presents an assessment of the diversity of drought impacts across Europe based on the European Drought Impact report Inventory (EDII), a unique research database that has collected close to 5000 impact reports from 33 European countries. The reported drought impacts were classified into major impact categories, each of which had a number of subtypes. The distribution of these categories and types was then analyzed over time, by country, across Europe and for particular drought events. The results show that impacts on agriculture and public water supply dominate the collection of drought impact reports for most countries and for all major drought events since the 1970s, while the number and relative fractions of reported impacts in other sectors can vary regionally and from event to event. The analysis also shows that reported impacts have increased over time as more media and website information has become available and environmental awareness has increased. Even though the distribution of impact categories is relatively consistent across Europe, the details of the reports show some differences. They confirm severe impacts in southern regions (particularly on agriculture and public water supply) and sector-specific impacts in central and northern regions (e.g., on forestry or energy production). The protocol developed thus enabled a new and more comprehensive view on drought impacts across Europe. Related studies have already developed statistical techniques to evaluate the link between drought indices and the categorized impacts using EDII data. The EDII is a living database and is a promising source for further research on

  12. Mental states as part of countertransference responses in psychotherapists facing reports of traumatic events of mourning and sexual violence.

    Science.gov (United States)

    Goldfeld, Patricia; Terra, Luciana; Abuchaim, Claudio; Sordi, Anne; Wiethaeuper, Daniela; Bouchard, Marc-Andrè; Mardini, Victor; Baumgardt, Rosana; Lauerman, Marta; Ceitlin, Lúcia Helena

    2008-09-01

    The study aims to compare the mental states and countertransference responses of 92 psychodynamically oriented psychotherapists, male and female, experienced and inexperienced, facing written reports of real patients who experienced traumatic events. Two vignettes were presented: one of a sexual violence, the other the sudden death of a significant person. The Mental States Rating System (MSRS; Bouchard, Picard, Audet, Brisson, & Carrier, 1998), the MSRS Self-Report (Goldfeld & Bouchard, 2004), and the Inventory of Countertransference Behavior (ICB; Friedman & Gelso, 2000) were used. Results showed that the mourning vignette led to more reflective responses (MSRS) and the rape case was associated with more negative countertransference reactions (ICB). Female participants were more reflective (MSRS); male therapists used less mentalized states (MSRS Self-Report) and expressed more negative reactions (ICB) for both scenarios. Experienced therapists showed more positive reactions on the ICB. The construct validity of the instruments is discussed in relation to the findings.

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

    Science.gov (United States)

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

    2018-05-15

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

  14. An Event-based Approach to Hybrid Systems Diagnosability

    Data.gov (United States)

    National Aeronautics and Space Administration — Diagnosability is an important issue in the design of diagnostic systems, because it helps identify whether sufficient information is available to distinguish all...

  15. Modeling Temporal Bias of Uplift Events in Recommender Systems

    KAUST Repository

    Altaf, Basmah

    2013-01-01

    company are worthwhile because marketing tactics greatly influence the consumer behavior. Alternatively, these advertising campaigns have a discernible impact on recommendation systems which tend to promote popular items by ranking them at the top

  16. Importance sampling of rare events in chaotic systems

    DEFF Research Database (Denmark)

    Leitão, Jorge C.; Parente Lopes, João M.Viana; Altmann, Eduardo G.

    2017-01-01

    space of chaotic systems. As examples of our general framework we compute the distribution of finite-time Lyapunov exponents (in different chaotic maps) and the distribution of escape times (in transient-chaos problems). Our methods sample exponentially rare states in polynomial number of samples (in......Finding and sampling rare trajectories in dynamical systems is a difficult computational task underlying numerous problems and applications. In this paper we show how to construct Metropolis-Hastings Monte-Carlo methods that can efficiently sample rare trajectories in the (extremely rough) phase...... both low- and high-dimensional systems). An open-source software that implements our algorithms and reproduces our results can be found in reference [J. Leitao, A library to sample chaotic systems, 2017, https://github.com/jorgecarleitao/chaospp]....

  17. Event-Driven Contrastive Divergence for Spiking Neuromorphic Systems

    Directory of Open Access Journals (Sweden)

    Emre eNeftci

    2014-01-01

    Full Text Available Restricted Boltzmann Machines (RBMs and Deep Belief Networks have been demonstrated to perform efficiently in variety of applications, such as dimensionality reduction, feature learning, and classification. Their implementation on neuromorphic hardware platforms emulating large-scale networks of spiking neurons can have significant advantages from the perspectives of scalability, power dissipation and real-time interfacing with the environment. However the traditional RBM architecture and the commonly used training algorithm known as Contrastive Divergence (CD are based on discrete updates and exact arithmetics which do not directly map onto a dynamical neural substrate. Here, we present an event-driven variation of CD to train a RBM constructed with Integrate & Fire (I&F neurons, that is constrained by the limitations of existing and near future neuromorphic hardware platforms. Our strategy is based on neural sampling, which allows us to synthesize a spiking neural network that samples from a target Boltzmann distribution. The reverberating activity of the network replaces the discrete steps of the CD algorithm, while Spike Time Dependent Plasticity (STDP carries out the weight updates in an online, asynchronous fashion.We demonstrate our approach by training an RBM composed of leaky I&F neurons with STDP synapses to learn a generative model of the MNIST hand-written digit dataset, and by testing it in recognition, generation and cue integration tasks. Our results contribute to a machine learning-driven approach for synthesizing networks of spiking neurons capable of carrying out practical, high-level functionality.

  18. Event-driven contrastive divergence for spiking neuromorphic systems.

    Science.gov (United States)

    Neftci, Emre; Das, Srinjoy; Pedroni, Bruno; Kreutz-Delgado, Kenneth; Cauwenberghs, Gert

    2013-01-01

    Restricted Boltzmann Machines (RBMs) and Deep Belief Networks have been demonstrated to perform efficiently in a variety of applications, such as dimensionality reduction, feature learning, and classification. Their implementation on neuromorphic hardware platforms emulating large-scale networks of spiking neurons can have significant advantages from the perspectives of scalability, power dissipation and real-time interfacing with the environment. However, the traditional RBM architecture and the commonly used training algorithm known as Contrastive Divergence (CD) are based on discrete updates and exact arithmetics which do not directly map onto a dynamical neural substrate. Here, we present an event-driven variation of CD to train a RBM constructed with Integrate & Fire (I&F) neurons, that is constrained by the limitations of existing and near future neuromorphic hardware platforms. Our strategy is based on neural sampling, which allows us to synthesize a spiking neural network that samples from a target Boltzmann distribution. The recurrent activity of the network replaces the discrete steps of the CD algorithm, while Spike Time Dependent Plasticity (STDP) carries out the weight updates in an online, asynchronous fashion. We demonstrate our approach by training an RBM composed of leaky I&F neurons with STDP synapses to learn a generative model of the MNIST hand-written digit dataset, and by testing it in recognition, generation and cue integration tasks. Our results contribute to a machine learning-driven approach for synthesizing networks of spiking neurons capable of carrying out practical, high-level functionality.

  19. 78 FR 63221 - Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the...

    Science.gov (United States)

    2013-10-23

    ...] Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... entitled ``Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary...

  20. 75 FR 29352 - Draft Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports...

    Science.gov (United States)

    2010-05-25

    ...] Draft Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry 188 entitled ``Data Elements for Submission of Veterinary Adverse Event Reports to the Center for...

  1. Survey of reportable events in nuclear power plants in the Federal Republic of Germany. Period covered: 2nd quarter 1994

    International Nuclear Information System (INIS)

    1994-01-01

    There were 40 reportable events in the period covered. 39 events belonged to the lowest reporting category N (normal notification, INES scale 0), 1 incident belongs to the category E (immediate notification, INES scale 1). There was no release above limit of radioactivity nor were there any effects on man or environment. (orig.) [de

  2. Adaptive Event-Triggered Control Based on Heuristic Dynamic Programming for Nonlinear Discrete-Time Systems.

    Science.gov (United States)

    Dong, Lu; Zhong, Xiangnan; Sun, Changyin; He, Haibo

    2017-07-01

    This paper presents the design of a novel adaptive event-triggered control method based on the heuristic dynamic programming (HDP) technique for nonlinear discrete-time systems with unknown system dynamics. In the proposed method, the control law is only updated when the event-triggered condition is violated. Compared with the periodic updates in the traditional adaptive dynamic programming (ADP) control, the proposed method can reduce the computation and transmission cost. An actor-critic framework is used to learn the optimal event-triggered control law and the value function. Furthermore, a model network is designed to estimate the system state vector. The main contribution of this paper is to design a new trigger threshold for discrete-time systems. A detailed Lyapunov stability analysis shows that our proposed event-triggered controller can asymptotically stabilize the discrete-time systems. Finally, we test our method on two different discrete-time systems, and the simulation results are included.

  3. Non-POSIX File System for LHCb Online Event Handling

    CERN Document Server

    Garnier, J C; Cherukuwada, S S

    2011-01-01

    LHCb aims to use its O(20000) CPU cores in the high level trigger (HLT) and its 120 TB Online storage system for data reprocessing during LHC shutdown periods. These periods can last a few days for technical maintenance or only a few hours during beam interfill gaps. These jobs run on files which are staged in from tape storage to the local storage buffer. The result are again one or more files. Efficient file writing and reading is essential for the performance of the system. Rather than using a traditional shared file-system such as NFS or CIFS we have implemented a custom, light-weight, non-Posix network file-system for the handling of these files. Streaming this file-system for the data-access allows to obtain high performance, while at the same time keep the resource consumption low and add nice features not found in NFS such as high-availability, transparent fail-over of the read and write service. The writing part of this streaming service is in successful use for the Online, real-time writing of the d...

  4. Analysis of adverse events of renal impairment related to platinum-based compounds using the Japanese Adverse Drug Event Report database.

    Science.gov (United States)

    Naganuma, Misa; Motooka, Yumi; Sasaoka, Sayaka; Hatahira, Haruna; Hasegawa, Shiori; Fukuda, Akiho; Nakao, Satoshi; Shimada, Kazuyo; Hirade, Koseki; Mori, Takayuki; Yoshimura, Tomoaki; Kato, Takeshi; Nakamura, Mitsuhiro

    2018-01-01

    Platinum compounds cause several adverse events, such as nephrotoxicity, gastrointestinal toxicity, myelosuppression, ototoxicity, and neurotoxicity. We evaluated the incidence of renal impairment as adverse events are related to the administration of platinum compounds using the Japanese Adverse Drug Event Report database. We analyzed adverse events associated with the use of platinum compounds reported from April 2004 to November 2016. The reporting odds ratio at 95% confidence interval was used to detect the signal for each renal impairment incidence. We evaluated the time-to-onset profile of renal impairment and assessed the hazard type using Weibull shape parameter and used the applied association rule mining technique to discover undetected relationships such as possible risk factor. In total, 430,587 reports in the Japanese Adverse Drug Event Report database were analyzed. The reporting odds ratios (95% confidence interval) for renal impairment resulting from the use of cisplatin, oxaliplatin, carboplatin, and nedaplatin were 2.7 (2.5-3.0), 0.6 (0.5-0.7), 0.8 (0.7-1.0), and 1.3 (0.8-2.1), respectively. The lower limit of the reporting odds ratio (95% confidence interval) for cisplatin was >1. The median (lower-upper quartile) onset time of renal impairment following the use of platinum-based compounds was 6.0-8.0 days. The Weibull shape parameter β and 95% confidence interval upper limit of oxaliplatin were impairment during cisplatin use in real-world setting. The present findings demonstrate that the incidence of renal impairment following cisplatin use should be closely monitored when patients are hypertensive or diabetic, or when they are co-administered furosemide, loxoprofen, or pemetrexed. In addition, healthcare professionals should closely assess a patient's background prior to treatment.

  5. On Event/Time Triggered and Distributed Analysis of a WSN System for Event Detection, Using Fuzzy Logic

    Directory of Open Access Journals (Sweden)

    Sofia Maria Dima

    2016-01-01

    Full Text Available Event detection in realistic WSN environments is a critical research domain, while the environmental monitoring comprises one of its most pronounced applications. Although efforts related to the environmental applications have been presented in the current literature, there is a significant lack of investigation on the performance of such systems, when applied in wireless environments. Aiming at addressing this shortage, in this paper an advanced multimodal approach is followed based on fuzzy logic. The proposed fuzzy inference system (FIS is implemented on TelosB motes and evaluates the probability of fire detection while aiming towards power conservation. Additionally to a straightforward centralized approach, a distributed implementation of the above FIS is also proposed, aiming towards network congestion reduction while optimally distributing the energy consumption among network nodes so as to maximize network lifetime. Moreover this work proposes an event based execution of the aforementioned FIS aiming to further reduce the computational as well as the communication cost, compared to a periodical time triggered FIS execution. As a final contribution, performance metrics acquired from all the proposed FIS implementation techniques are thoroughly compared and analyzed with respect to critical network conditions aiming to offer realistic evaluation and thus objective conclusions’ extraction.

  6. Adaptive neuro-fuzzy inference systems for semi-automatic discrimination between seismic events: a study in Tehran region

    Science.gov (United States)

    Vasheghani Farahani, Jamileh; Zare, Mehdi; Lucas, Caro

    2012-04-01

    Thisarticle presents an adaptive neuro-fuzzy inference system (ANFIS) for classification of low magnitude seismic events reported in Iran by the network of Tehran Disaster Mitigation and Management Organization (TDMMO). ANFIS classifiers were used to detect seismic events using six inputs that defined the seismic events. Neuro-fuzzy coding was applied using the six extracted features as ANFIS inputs. Two types of events were defined: weak earthquakes and mining blasts. The data comprised 748 events (6289 signals) ranging from magnitude 1.1 to 4.6 recorded at 13 seismic stations between 2004 and 2009. We surveyed that there are almost 223 earthquakes with M ≤ 2.2 included in this database. Data sets from the south, east, and southeast of the city of Tehran were used to evaluate the best short period seismic discriminants, and features as inputs such as origin time of event, distance (source to station), latitude of epicenter, longitude of epicenter, magnitude, and spectral analysis (fc of the Pg wave) were used, increasing the rate of correct classification and decreasing the confusion rate between weak earthquakes and quarry blasts. The performance of the ANFIS model was evaluated for training and classification accuracy. The results confirmed that the proposed ANFIS model has good potential for determining seismic events.

  7. The sequence coding and search system: An approach for constructing and analyzing event sequences at commercial nuclear power plants

    International Nuclear Information System (INIS)

    Mays, G.T.

    1989-04-01

    The US Nuclear Regulatory Commission (NRC) has recognized the importance of the collection, assessment, and feedstock of operating experience data from commercial nuclear power plants and has centralized these activities in the Office for Analysis and Evaluation of Operational Data (AEOD). Such data is essential for performing safety and reliability analyses, especially analyses of trends and patterns to identify undesirable changes in plant performance at the earliest opportunity to implement corrective measures to preclude the occurrences of a more serious event. One of NRC's principal tools for collecting and evaluating operating experience data is the Sequence Coding and Search System (SCSS). The SCSS consists of a methodology for structuring event sequences and the requisite computer system to store and search the data. The source information for SCSS is the Licensee Event Report (LER), which is a legally required document. This paper describes the objective SCSS, the information it contains, and the format and approach for constructuring SCSS event sequences. Examples are presented demonstrating the use SCSS to support the analysis of LER data. The SCSS contains over 30,000 LERs describing events from 1980 through the present. Insights gained from working with a complex data system from the initial developmental stage to the point of a mature operating system are highlighted

  8. The sequence coding and search system: an approach for constructing and analyzing event sequences at commercial nuclear power plants

    International Nuclear Information System (INIS)

    Mays, G.T.

    1990-01-01

    The U.S. Nuclear Regulatory Commission (NRC) has recognized the importance of the collection, assessment, and feedback of operating experience data from commercial nuclear power plants and has centralized these activities in the Office for Analysis and Evaluation of Operational Data (AEOD). Such data is essential for performing safety and reliability analyses, especially analyses of trends and patterns to identify undesirable changes in plant performance at the earliest opportunity to implement corrective measures to preclude the occurrence of a more serious event. One of NRC's principal tools for collecting and evaluating operating experience data is the Sequence Coding and Search System (SCSS). The SCSS consists of a methodology for structuring event sequences and the requisite computer system to store and search the data. The source information for SCSS is the Licensee Event Report (LER), which is a legally required document. This paper describes the objectives of SCSS, the information it contains, and the format and approach for constructing SCSS event sequences. Examples are presented demonstrating the use of SCSS to support the analysis of LER data. The SCSS contains over 30,000 LERs describing events from 1980 through the present. Insights gained from working with a complex data system from the initial developmental stage to the point of a mature operating system are highlighted. Considerable experience has been gained in the areas of evolving and changing data requirements, staffing requirements, and quality control and quality assurance procedures for addressing consistency, software/hardware considerations for developing and maintaining a complex system, documentation requirements, and end-user needs. Two other approaches for constructing and evaluating event sequences are examined including the Accident Precursor Program (ASP) where sequences having the potential for core damage are identified and analyzed, and the Significant Event Compilation Tree

  9. Dietary supplement adverse events: report of a one-year poison center surveillance project.

    Science.gov (United States)

    Haller, Christine; Kearney, Tom; Bent, Stephen; Ko, Richard; Benowitz, Neal; Olson, Kent

    2008-06-01

    The safety and efficacy of dietary supplements is of growing concern to regulators, health-care providers and consumers. Few scientific data exist on clinical effects and potential toxicities of marketed products. Harmful supplements may not be identified for months or years with existing adverse event monitoring mechanisms. Retrospective review of poison center statistics to capture supplement-associated toxicity also has limitations. We collaborated with the FDA Center for Food Safety and Nutrition (CFSAN) to conduct a 1-year prospective surveillance study of dietary supplement-related poison control center calls in 2006. Prompt follow-up of symptomatic cases, laboratory analysis of implicated dietary supplements, and causality assessment by a case review expert panel were performed. Of 275 dietary supplements calls, 41% involved symptomatic exposures; and two-thirds were rated as probably or possibly related to supplement use. Eight adverse events required hospital admission. Sympathomimetic toxicity was most common, with caffeine products accounting for 47%, and yohimbe products accounting for 18% of supplement-related symptomatic cases. Suspected drug-herb interactions occurred in 6 cases, including yohimbe co-ingested with buproprion (1) and methamphetamine (3), and additive anticoagulant/antiplatelet effects of NSAIDs taken with fish oils (1) and ginkgo (1). Laboratory analysis identified a pharmacologically active substance in 4 cases; supplement toxicity was ruled unlikely when analytical testing was negative in 5 cases. Most supplement-related adverse events were minor. Clinically significant toxic effects were most frequently reported with caffeine and yohimbe-containing products. Active surveillance of poison control center reports of dietary supplement adverse events enables rapid detection of potentially harmful products, which may facilitate regulatory oversight.

  10. Rare event simulation for highly dependable systems with fast repairs

    NARCIS (Netherlands)

    Reijsbergen, D.P.; de Boer, Pieter-Tjerk; Scheinhardt, Willem R.W.; Haverkort, Boudewijn R.H.M.

    2010-01-01

    Stochastic model checking has been used recently to assess, among others, dependability measures for a variety of systems. However, the employed numerical methods, as, e.g., supported by model checking tools such as PRISM and MRMC, suffer from the state-space explosion problem. The main alternative

  11. Rare event simulation for highly dependable systems with fast repairs

    NARCIS (Netherlands)

    Reijsbergen, D.P.; de Boer, Pieter-Tjerk; Scheinhardt, Willem R.W.; Haverkort, Boudewijn R.H.M.

    Probabilistic model checking has been used recently to assess, among others, dependability measures for a variety of systems. However, the numerical methods employed, such as those supported by model checking tools such as PRISM and MRMC, suffer from the state-space explosion problem. The main

  12. Development and evaluation of a computerbased instrument supporting event analysis in NPP. Final report

    International Nuclear Information System (INIS)

    Szameitat, S.

    2002-11-01

    Information technologies (IT) in safety management are seen as opportunity to control and reduce risks. The processing of safety-critical event information, a central function of safety management, could be more efficient using computers. But organization structures are different, the processes of experience transfer are complex and the opportunities of IT are broad. To implement a support system is to question about design criteria of computer support for an event-based safety management system (eSMS). Two studies were conducted. Study 1 compares the organizational, technical and legal conditions for Safety Management in the German Nuclear Industry and the Norwegian Offshore Industry. It could identify design criteria, which independent from the operator influence the eSMS. Study 2 compares the eSMS of different nuclear power plants analyzing the organization structures and processes. Those internal and external criteria have a significant influence on a efficient design of a system support for eSMS. The third study makes the options and impact of computer support on experience transfer in eSMS as subject of discussion. For this purpose a simulation environment has been created. Groups investigated typical event scenarios from a nuclear power plant for contributing factors. The communication medium has been manipulated (face-to-face versus computer-mediated). Results of 15 groups indicate, that the collection of event information was promoted by computer-mediated communication. This is the foundation of the identification of contributing factors. The depth of analysis has not been influenced. Computer mediation hampers the learning of facts. IT can support safety management effectively. (orig.) [de

  13. Parallelized event chain algorithm for dense hard sphere and polymer systems

    International Nuclear Information System (INIS)

    Kampmann, Tobias A.; Boltz, Horst-Holger; Kierfeld, Jan

    2015-01-01

    We combine parallelization and cluster Monte Carlo for hard sphere systems and present a parallelized event chain algorithm for the hard disk system in two dimensions. For parallelization we use a spatial partitioning approach into simulation cells. We find that it is crucial for correctness to ensure detailed balance on the level of Monte Carlo sweeps by drawing the starting sphere of event chains within each simulation cell with replacement. We analyze the performance gains for the parallelized event chain and find a criterion for an optimal degree of parallelization. Because of the cluster nature of event chain moves massive parallelization will not be optimal. Finally, we discuss first applications of the event chain algorithm to dense polymer systems, i.e., bundle-forming solutions of attractive semiflexible polymers

  14. Fine grained event processing on HPCs with the ATLAS Yoda system

    CERN Document Server

    Calafiura, Paolo; The ATLAS collaboration; Guan, Wen; Maeno, Tadashi; Nilsson, Paul; Oleynik, Danila; Panitkin, Sergey; Tsulaia, Vakhtang; van Gemmeren, Peter; Wenaus, Torre

    2015-01-01

    High performance computing facilities present unique challenges and opportunities for HENP event processing. The massive scale of many HPC systems means that fractionally small utilizations can yield large returns in processing throughput. Parallel applications which can dynamically and efficiently fill any scheduling opportunities the resource presents benefit both the facility (maximal utilization) and the (compute-limited) science. The ATLAS Yoda system provides this capability to HENP-like event processing applications by implementing event-level processing in an MPI-based master-client model that integrates seamlessly with the more broadly scoped ATLAS Event Service. Fine grained, event level work assignments are intelligently dispatched to parallel workers to sustain full utilization on all cores, with outputs streamed off to destination object stores in near real time with similarly fine granularity, such that processing can proceed until termination with full utilization. The system offers the efficie...

  15. Event reporting guidelines 10 CFR 50.72 and 50.73. Revision 1

    Energy Technology Data Exchange (ETDEWEB)

    Allison, D P; Harper, M R; Jones, W R; MacKinnon, J B; Sandin, S S

    1998-01-01

    Revision 1 to NUREG-1022 clarifies the immediate notification requirements of Title 10 of the Code of Federal Regulations, Part 50, Section 50.72 (10 CFR 50.72), and the 30-day written licensee event report (LER) requirements of 10 CFR 50.73 for nuclear power plants. This revision was initiated to improve the reporting guidelines related to 10 CFR 50.72 and 50.73 and to consolidate these guidelines into a single reference document. A first draft of this document was noticed for public comment in the Federal Register on october 7, 1991 (56 FR 50598). A second draft was noticed for comment in the Federal Register on February 7, 1994 (59 FR 5614). This document updates and supersedes NUREG-1022 and its Supplements 1 and 2 (published in September 1983, February 1984, and September 1985, respectively). It does not change the reporting requirements of 10 CFR 50.72 and 50.73.

  16. Event reporting guidelines 10 CFR 50.72 and 50.73. Revision 1

    International Nuclear Information System (INIS)

    Allison, D.P.; Harper, M.R.; Jones, W.R.; MacKinnon, J.B.; Sandin, S.S.

    1998-01-01

    Revision 1 to NUREG-1022 clarifies the immediate notification requirements of Title 10 of the Code of Federal Regulations, Part 50, Section 50.72 (10 CFR 50.72), and the 30-day written licensee event report (LER) requirements of 10 CFR 50.73 for nuclear power plants. This revision was initiated to improve the reporting guidelines related to 10 CFR 50.72 and 50.73 and to consolidate these guidelines into a single reference document. A first draft of this document was noticed for public comment in the Federal Register on october 7, 1991 (56 FR 50598). A second draft was noticed for comment in the Federal Register on February 7, 1994 (59 FR 5614). This document updates and supersedes NUREG-1022 and its Supplements 1 and 2 (published in September 1983, February 1984, and September 1985, respectively). It does not change the reporting requirements of 10 CFR 50.72 and 50.73

  17. Faulted systems recovery experience. Final report, May 1992

    International Nuclear Information System (INIS)

    1992-05-01

    This report addresses the recovery (i.e., return to service from a faulted, or otherwise unavailable, condition) of important nuclear power plant front-line and support systems and equipment. It contains information based on operating experience relative to the times to recover from a variety of plant events. It also indicates the nature of the operator actions involved. This information is intended to provide useful insights to utilities who are undertaking Individual Plant Examinations (IPEs) per Generic Letter 88-20 of the Nuclear Regulatory Commission. The report provides a database of recovery experience primarily derived from Licensee Event Reports (LERs). The database contains recovery duration information for 205 demand events and 98 nondemand events. In particular, it contains recovery durations for 42 pump related and 143 valve related events that are representative of demand conditions. Experience shows that, overall, about one-half of all pumps and valves are recovered in 30 minutes or less. Specific recovery experience is dependent on the equipment type, the plant system involved, and the failure mode encountered. (author)

  18. Trajectory-probed instability and statistics of desynchronization events in coupled chaotic systems

    Energy Technology Data Exchange (ETDEWEB)

    Oliveira, Gilson F. de, E-mail: gilson@otica.ufpb.br; Chevrollier, Martine; Oriá, Marcos [Departamento de Física, Universidade Federal da Paraíba, Caixa Postal 5008, 58051-900 João Pessoa-PB (Brazil); Passerat de Silans, Thierry [Departamento de Física, Universidade Federal da Paraíba, Caixa Postal 5008, 58051-900 João Pessoa-PB (Brazil); UAF, Universidade Federal de Campina Grande, 58429-900 Campina Grande, PB (Brazil); Souza Cavalcante, Hugo L. D. de [Departamento de Informática, Centro de Informática, Universidade Federal da Paraíba, Av. dos Escoteiros s/n, Mangabeira VII, 58055-000 João Pessoa, PB (Brazil)

    2015-11-15

    Complex systems, such as financial markets, earthquakes, and neurological networks, exhibit extreme events whose mechanisms of formation are not still completely understood. These mechanisms may be identified and better studied in simpler systems with dynamical features similar to the ones encountered in the complex system of interest. For instance, sudden and brief departures from the synchronized state observed in coupled chaotic systems were shown to display non-normal statistical distributions similar to events observed in the complex systems cited above. The current hypothesis accepted is that these desynchronization events are influenced by the presence of unstable object(s) in the phase space of the system. Here, we present further evidence that the occurrence of large events is triggered by the visitation of the system's phase-space trajectory to the vicinity of these unstable objects. In the system studied here, this visitation is controlled by a single parameter, and we exploit this feature to observe the effect of the visitation rate in the overall instability of the synchronized state. We find that the probability of escapes from the synchronized state and the size of those desynchronization events are enhanced in attractors whose shapes permit the chaotic trajectories to approach the region of strong instability. This result shows that the occurrence of large events requires not only a large local instability to amplify noise, or to amplify the effect of parameter mismatch between the coupled subsystems, but also that the trajectories of the system wander close to this local instability.

  19. Trajectory-probed instability and statistics of desynchronization events in coupled chaotic systems

    International Nuclear Information System (INIS)

    Oliveira, Gilson F. de; Chevrollier, Martine; Oriá, Marcos; Passerat de Silans, Thierry; Souza Cavalcante, Hugo L. D. de

    2015-01-01

    Complex systems, such as financial markets, earthquakes, and neurological networks, exhibit extreme events whose mechanisms of formation are not still completely understood. These mechanisms may be identified and better studied in simpler systems with dynamical features similar to the ones encountered in the complex system of interest. For instance, sudden and brief departures from the synchronized state observed in coupled chaotic systems were shown to display non-normal statistical distributions similar to events observed in the complex systems cited above. The current hypothesis accepted is that these desynchronization events are influenced by the presence of unstable object(s) in the phase space of the system. Here, we present further evidence that the occurrence of large events is triggered by the visitation of the system's phase-space trajectory to the vicinity of these unstable objects. In the system studied here, this visitation is controlled by a single parameter, and we exploit this feature to observe the effect of the visitation rate in the overall instability of the synchronized state. We find that the probability of escapes from the synchronized state and the size of those desynchronization events are enhanced in attractors whose shapes permit the chaotic trajectories to approach the region of strong instability. This result shows that the occurrence of large events requires not only a large local instability to amplify noise, or to amplify the effect of parameter mismatch between the coupled subsystems, but also that the trajectories of the system wander close to this local instability

  20. Trajectory-probed instability and statistics of desynchronization events in coupled chaotic systems

    Science.gov (United States)

    de Oliveira, Gilson F.; Chevrollier, Martine; Passerat de Silans, Thierry; Oriá, Marcos; de Souza Cavalcante, Hugo L. D.

    2015-11-01

    Complex systems, such as financial markets, earthquakes, and neurological networks, exhibit extreme events whose mechanisms of formation are not still completely understood. These mechanisms may be identified and better studied in simpler systems with dynamical features similar to the ones encountered in the complex system of interest. For instance, sudden and brief departures from the synchronized state observed in coupled chaotic systems were shown to display non-normal statistical distributions similar to events observed in the complex systems cited above. The current hypothesis accepted is that these desynchronization events are influenced by the presence of unstable object(s) in the phase space of the system. Here, we present further evidence that the occurrence of large events is triggered by the visitation of the system's phase-space trajectory to the vicinity of these unstable objects. In the system studied here, this visitation is controlled by a single parameter, and we exploit this feature to observe the effect of the visitation rate in the overall instability of the synchronized state. We find that the probability of escapes from the synchronized state and the size of those desynchronization events are enhanced in attractors whose shapes permit the chaotic trajectories to approach the region of strong instability. This result shows that the occurrence of large events requires not only a large local instability to amplify noise, or to amplify the effect of parameter mismatch between the coupled subsystems, but also that the trajectories of the system wander close to this local instability.

  1. How to Take HRMS Process Management to the Next Level with Workflow Business Event System

    Science.gov (United States)

    Rajeshuni, Sarala; Yagubian, Aram; Kunamaneni, Krishna

    2006-01-01

    Oracle Workflow with the Business Event System offers a complete process management solution for enterprises to manage business processes cost-effectively. Using Workflow event messaging, event subscriptions, AQ Servlet and advanced queuing technologies, this presentation will demonstrate the step-by-step design and implementation of system solutions in order to integrate two dissimilar systems and establish communication remotely. As a case study, the presentation walks you through the process of propagating organization name changes in other applications that originated from the HRMS module without changing applications code. The solution can be applied to your particular business cases for streamlining or modifying business processes across Oracle and non-Oracle applications.

  2. Tag and Neighbor based Recommender systems for Medical events

    DEFF Research Database (Denmark)

    Bayyapu, Karunakar Reddy; Dolog, Peter

    2010-01-01

    This paper presents an extension of a multifactor recommendation approach based on user tagging with term neighbours. Neighbours of words in tag vectors and documents provide for hitting larger set of documents and not only those matching with direct tag vectors or content of the documents. Tag...... in the situations where the quality of tags is lower. We discuss the approach on the examples from the existing Medworm system to indicate the usefulness of the approach....

  3. Improving the Teaching of Discrete-Event Control Systems Using a LEGO Manufacturing Prototype

    Science.gov (United States)

    Sanchez, A.; Bucio, J.

    2012-01-01

    This paper discusses the usefulness of employing LEGO as a teaching-learning aid in a post-graduate-level first course on the control of discrete-event systems (DESs). The final assignment of the course is presented, which asks students to design and implement a modular hierarchical discrete-event supervisor for the coordination layer of a…

  4. Verification of Large State/Event Systems using Compositionality and Dependency Analysis

    DEFF Research Database (Denmark)

    Lind-Nielsen, Jørn; Andersen, Henrik Reif; Hulgaard, Henrik

    2001-01-01

    A state/event model is a concurrent version of Mealy machines used for describing embedded reactive systems. This paper introduces a technique that uses compositionality and dependency analysis to significantly improve the efficiency of symbolic model checking of state/event models. It makes...

  5. Verification of Large State/Event Systems using Compositionality and Dependency Analysis

    DEFF Research Database (Denmark)

    Lind-Nielsen, Jørn; Andersen, Henrik Reif; Behrmann, Gerd

    1999-01-01

    A state/event model is a concurrent version of Mealy machines used for describing embedded reactive systems. This paper introduces a technique that uses \\emph{compositionality} and \\emph{dependency analysis} to significantly improve the efficiency of symbolic model checking of state/event models...

  6. Systems analysis department annual progress report 1986

    International Nuclear Information System (INIS)

    Grohnheit, P.E.; Larsen, H.; Vestergaard, N.K.

    1987-02-01

    The report describes the work of the Systems Analysis Department at Risoe National Laboratory during 1986. The activities may be classified as energy systems analysis and risk and reliability analysis. The report includes a list of staff members. (author)

  7. High-Performance Monitoring Architecture for Large-Scale Distributed Systems Using Event Filtering

    Science.gov (United States)

    Maly, K.

    1998-01-01

    Monitoring is an essential process to observe and improve the reliability and the performance of large-scale distributed (LSD) systems. In an LSD environment, a large number of events is generated by the system components during its execution or interaction with external objects (e.g. users or processes). Monitoring such events is necessary for observing the run-time behavior of LSD systems and providing status information required for debugging, tuning and managing such applications. However, correlated events are generated concurrently and could be distributed in various locations in the applications environment which complicates the management decisions process and thereby makes monitoring LSD systems an intricate task. We propose a scalable high-performance monitoring architecture for LSD systems to detect and classify interesting local and global events and disseminate the monitoring information to the corresponding end- points management applications such as debugging and reactive control tools to improve the application performance and reliability. A large volume of events may be generated due to the extensive demands of the monitoring applications and the high interaction of LSD systems. The monitoring architecture employs a high-performance event filtering mechanism to efficiently process the large volume of event traffic generated by LSD systems and minimize the intrusiveness of the monitoring process by reducing the event traffic flow in the system and distributing the monitoring computation. Our architecture also supports dynamic and flexible reconfiguration of the monitoring mechanism via its Instrumentation and subscription components. As a case study, we show how our monitoring architecture can be utilized to improve the reliability and the performance of the Interactive Remote Instruction (IRI) system which is a large-scale distributed system for collaborative distance learning. The filtering mechanism represents an Intrinsic component integrated

  8. National Fire Incident Reporting System (NFIRS)

    Data.gov (United States)

    Department of Homeland Security — The National Fire Incident Reporting System (NFIRS) is a reporting standard that fire departments use to uniformly report on the full range of their activities, from...

  9. An Attempt at Matching Waking Events Into Dream Reports by Independent Judges

    Science.gov (United States)

    Wang, Jia Xi; Shen, He Yong

    2018-01-01

    Correlations between memories and dreaming has typically been studied by linking conscious experiences and dream reports, which has illustrated that dreaming reflects waking life events, thoughts, and emotions. As some research suggests that sleep has a function of memory consolidation, and dreams reflect this, researching this relationship further may uncover more useful insights. However, most related research has been conducted using the self-report method which asks participants to judge the relationship between their own conscious experiences and dreams. This method may cause errors when the research purpose is to make comparisons between different groups, because individual differences cannot be balanced out when the results are compared among groups. Based on a knowledge of metaphors and symbols, we developed two operationalized definitions for independent judges to match conscious experiences and dreams, the descriptive incorporation and the metaphorical incorporation, and tested their reliability for the matching purpose. Two independent judges were asked to complete a linking task for 212 paired event-dreams. Results showed almost half dreams can be matched by independent judges, and the independent-judge method could provide similar proportions for the linking task, when compared with the self-report method. PMID:29681873

  10. A Discrete Event System Approach to Online Testing of Speed Independent Circuits

    Directory of Open Access Journals (Sweden)

    P. K. Biswal

    2015-01-01

    Full Text Available With the increase in soft failures in deep submicron ICs, online testing is becoming an integral part of design for testability. Some techniques for online testing of asynchronous circuits are proposed in the literature, which involves development of a checker that verifies the correctness of the protocol. This checker involves Mutex blocks making its area overhead quite high. In this paper, we have adapted the Theory of Fault Detection and Diagnosis available in the literature on Discrete Event Systems to online testing of speed independent asynchronous circuits. The scheme involves development of a state based model of the circuit, under normal and various stuck-at fault conditions, and finally designing state estimators termed as detectors. The detectors monitor the circuit online and determine whether it is functioning in normal/failure mode. The main advantages are nonintrusiveness and low area overheads compared to similar schemes reported in the literature.

  11. Noether's Theorem and its Inverse of Birkhoffian System in Event Space Based on Herglotz Variational Problem

    Science.gov (United States)

    Tian, X.; Zhang, Y.

    2018-03-01

    Herglotz variational principle, in which the functional is defined by a differential equation, generalizes the classical ones defining the functional by an integral. The principle gives a variational principle description of nonconservative systems even when the Lagrangian is independent of time. This paper focuses on studying the Noether's theorem and its inverse of a Birkhoffian system in event space based on the Herglotz variational problem. Firstly, according to the Herglotz variational principle of a Birkhoffian system, the principle of a Birkhoffian system in event space is established. Secondly, its parametric equations and two basic formulae for the variation of Pfaff-Herglotz action of a Birkhoffian system in event space are obtained. Furthermore, the definition and criteria of Noether symmetry of the Birkhoffian system in event space based on the Herglotz variational problem are given. Then, according to the relationship between the Noether symmetry and conserved quantity, the Noether's theorem is derived. Under classical conditions, Noether's theorem of a Birkhoffian system in event space based on the Herglotz variational problem reduces to the classical ones. In addition, Noether's inverse theorem of the Birkhoffian system in event space based on the Herglotz variational problem is also obtained. In the end of the paper, an example is given to illustrate the application of the results.

  12. Real-time distributed fiber optic sensor for security systems: Performance, event classification and nuisance mitigation

    Science.gov (United States)

    Mahmoud, Seedahmed S.; Visagathilagar, Yuvaraja; Katsifolis, Jim

    2012-09-01

    The success of any perimeter intrusion detection system depends on three important performance parameters: the probability of detection (POD), the nuisance alarm rate (NAR), and the false alarm rate (FAR). The most fundamental parameter, POD, is normally related to a number of factors such as the event of interest, the sensitivity of the sensor, the installation quality of the system, and the reliability of the sensing equipment. The suppression of nuisance alarms without degrading sensitivity in fiber optic intrusion detection systems is key to maintaining acceptable performance. Signal processing algorithms that maintain the POD and eliminate nuisance alarms are crucial for achieving this. In this paper, a robust event classification system using supervised neural networks together with a level crossings (LCs) based feature extraction algorithm is presented for the detection and recognition of intrusion and non-intrusion events in a fence-based fiber-optic intrusion detection system. A level crossings algorithm is also used with a dynamic threshold to suppress torrential rain-induced nuisance alarms in a fence system. Results show that rain-induced nuisance alarms can be suppressed for rainfall rates in excess of 100 mm/hr with the simultaneous detection of intrusion events. The use of a level crossing based detection and novel classification algorithm is also presented for a buried pipeline fiber optic intrusion detection system for the suppression of nuisance events and discrimination of intrusion events. The sensor employed for both types of systems is a distributed bidirectional fiber-optic Mach-Zehnder (MZ) interferometer.

  13. Using event-B for critical device software systems

    CERN Document Server

    Singh, Neeraj Kumar

    2013-01-01

    Defining a new development life-cycle methodology, together with a set of associated techniques and tools to develop highly critical systems using formal techniques, this book adopts a rigorous safety assessment approach explored via several layers (from requirements analysis to automatic source code generation). This is assessed and evaluated via a standard case study: the cardiac pacemaker. Additionally a formalisation of an Electrocardiogram (ECG) is used to identify anomalies in order to improve existing medical protocols. This allows the key issue - that formal methods are not currently i

  14. Adverse events following immunisation with a meningococcal serogroup B vaccine: report from post-marketing surveillance, Germany, 2013 to 2016.

    Science.gov (United States)

    Mentzer, Dirk; Oberle, Doris; Keller-Stanislawski, Brigitte

    2018-04-01

    Background and aimIn January 2013, a novel vaccine against Neisseria meningitidis serogroup B, the multicomponent meningococcal serogroup B vaccine (4CMenB), was approved by the European Medicines Agency. We aimed to evaluate the safety profile of this vaccine. Methods: All adverse events following immunisation (AEFI) reported from Germany since the vaccine's launch in Germany in November 2013 through December 2016 were reviewed and analysed. Results: Through December 2016, a total of 664 individual case safety reports (ICSR) notifying 1,960 AEFI were received. A majority of vaccinees for whom AEFI were reported were children 2 to 11 years of age (n = 280; 42.2%) followed by infants and toddlers aged 28 days to 23 months (n = 170; 25.6%). General disorders and administration site conditions was the System Organ Class (SOC) with the majority of AEFI (n = 977; 49.8%), followed by nervous system disorders (n = 249; 12.7%), and skin and subcutaneous tissue disorders (n = 191; 9.7%). Screening of patient records for immune-mediated and neurological diseases did not raise any safety signal in terms of an increased proportional reporting ratio (PRR). Conclusions: The safety profile described in the Summary of Product Characteristics, in general, is confirmed by data from spontaneous reporting. No safety concerns were identified.

  15. AKDNR - DNR Business Reporting System (DBRS)

    Science.gov (United States)

    Skip to content State of Alaska myAlaska My Government Resident Business in Alaska Visiting Alaska Resources > IRM GPU > Main Menu DNR Business Reporting System (DBRS) The DNR Business Reporting System (DBRS) allows users to generate reports from the DNR Business databases and maps. The reports offered

  16. Modeling Temporal Bias of Uplift Events in Recommender Systems

    KAUST Repository

    Altaf, Basmah

    2013-05-08

    Today, commercial industry spends huge amount of resources in advertisement campaigns, new marketing strategies, and promotional deals to introduce their product to public and attract a large number of customers. These massive investments by a company are worthwhile because marketing tactics greatly influence the consumer behavior. Alternatively, these advertising campaigns have a discernible impact on recommendation systems which tend to promote popular items by ranking them at the top, resulting in biased and unfair decision making and loss of customers’ trust. The biasing impact of popularity of items on recommendations, however, is not fixed, and varies with time. Therefore, it is important to build a bias-aware recommendation system that can rank or predict items based on their true merit at given time frame. This thesis proposes a framework that can model the temporal bias of individual items defined by their characteristic contents, and provides a simple process for bias correction. Bias correction is done either by cleaning the bias from historical training data that is used for building predictive model, or by ignoring the estimated bias from the predictions of a standard predictor. Evaluated on two real world datasets, NetFlix and MovieLens, our framework is shown to be able to estimate and remove the bias as a result of adopted marketing techniques from the predicted popularity of items at a given time.

  17. Airport Economics: Management Control Financial Reporting Systems

    Science.gov (United States)

    Buchbinder, A.

    1972-01-01

    The development of management control financial reporting systems for airport operation is discussed. The operation of the system to provide the reports required for determining the specific revenue producing facilities of airports is described. The organization of the cost reporting centers to show the types of information provided by the system is analyzed.

  18. Final Scientific Report, Integrated Seismic Event Detection and Location by Advanced Array Processing

    Energy Technology Data Exchange (ETDEWEB)

    Kvaerna, T.; Gibbons. S.J.; Ringdal, F; Harris, D.B.

    2007-01-30

    In the field of nuclear explosion monitoring, it has become a priority to detect, locate, and identify seismic events down to increasingly small magnitudes. The consideration of smaller seismic events has implications for a reliable monitoring regime. Firstly, the number of events to be considered increases greatly; an exponential increase in naturally occurring seismicity is compounded by large numbers of seismic signals generated by human activity. Secondly, the signals from smaller events become more difficult to detect above the background noise and estimates of parameters required for locating the events may be subject to greater errors. Thirdly, events are likely to be observed by a far smaller number of seismic stations, and the reliability of event detection and location using a very limited set of observations needs to be quantified. For many key seismic stations, detection lists may be dominated by signals from routine industrial explosions which should be ascribed, automatically and with a high level of confidence, to known sources. This means that expensive analyst time is not spent locating routine events from repeating seismic sources and that events from unknown sources, which could be of concern in an explosion monitoring context, are more easily identified and can be examined with due care. We have obtained extensive lists of confirmed seismic events from mining and other artificial sources which have provided an excellent opportunity to assess the quality of existing fully-automatic event bulletins and to guide the development of new techniques for online seismic processing. Comparing the times and locations of confirmed events from sources in Fennoscandia and NW Russia with the corresponding time and location estimates reported in existing automatic bulletins has revealed substantial mislocation errors which preclude a confident association of detected signals with known industrial sources. The causes of the errors are well understood and are

  19. Final Scientific Report, Integrated Seismic Event Detection and Location by Advanced Array Processing

    International Nuclear Information System (INIS)

    Kvaerna, T.; Gibbons. S.J.; Ringdal, F; Harris, D.B.

    2007-01-01

    In the field of nuclear explosion monitoring, it has become a priority to detect, locate, and identify seismic events down to increasingly small magnitudes. The consideration of smaller seismic events has implications for a reliable monitoring regime. Firstly, the number of events to be considered increases greatly; an exponential increase in naturally occurring seismicity is compounded by large numbers of seismic signals generated by human activity. Secondly, the signals from smaller events become more difficult to detect above the background noise and estimates of parameters required for locating the events may be subject to greater errors. Thirdly, events are likely to be observed by a far smaller number of seismic stations, and the reliability of event detection and location using a very limited set of observations needs to be quantified. For many key seismic stations, detection lists may be dominated by signals from routine industrial explosions which should be ascribed, automatically and with a high level of confidence, to known sources. This means that expensive analyst time is not spent locating routine events from repeating seismic sources and that events from unknown sources, which could be of concern in an explosion monitoring context, are more easily identified and can be examined with due care. We have obtained extensive lists of confirmed seismic events from mining and other artificial sources which have provided an excellent opportunity to assess the quality of existing fully-automatic event bulletins and to guide the development of new techniques for online seismic processing. Comparing the times and locations of confirmed events from sources in Fennoscandia and NW Russia with the corresponding time and location estimates reported in existing automatic bulletins has revealed substantial mislocation errors which preclude a confident association of detected signals with known industrial sources. The causes of the errors are well understood and are

  20. Adverse events following yellow fever immunization: Report and analysis of 67 neurological cases in Brazil.

    Science.gov (United States)

    Martins, Reinaldo de Menezes; Pavão, Ana Luiza Braz; de Oliveira, Patrícia Mouta Nunes; dos Santos, Paulo Roberto Gomes; Carvalho, Sandra Maria D; Mohrdieck, Renate; Fernandes, Alexandre Ribeiro; Sato, Helena Keico; de Figueiredo, Patricia Mandali; von Doellinger, Vanessa Dos Reis; Leal, Maria da Luz Fernandes; Homma, Akira; Maia, Maria de Lourdes S

    2014-11-20

    Neurological adverse events following administration of the 17DD substrain of yellow fever vaccine (YEL-AND) in the Brazilian population are described and analyzed. Based on information obtained from the National Immunization Program through passive surveillance or intensified passive surveillance, from 2007 to 2012, descriptive analysis, national and regional rates of YFV associated neurotropic, neurological autoimmune disease, and reporting rate ratios with their respective 95% confidence intervals were calculated for first time vaccinees stratified on age and year. Sixty-seven neurological cases were found, with the highest rate of neurological adverse events in the age group from 5 to 9 years (2.66 per 100,000 vaccine doses in Rio Grande do Sul state, and 0.83 per 100,000 doses in national analysis). Two cases had a combination of neurotropic and autoimmune features. This is the largest sample of YEL-AND already analyzed. Rates are similar to other recent studies, but on this study the age group from 5 to 9 years of age had the highest risk. As neurological adverse events have in general a good prognosis, they should not contraindicate the use of yellow fever vaccine in face of risk of infection by yellow fever virus. Copyright © 2014 Elsevier Ltd. All rights reserved.

  1. Optical timing receiver for the NASA Spaceborne Ranging System. Part II: high precision event-timing digitizer

    Energy Technology Data Exchange (ETDEWEB)

    Leskovar, Branko; Turko, Bojan

    1978-08-01

    Position-resolution capabilities of the NASA Spaceborne Laser Ranging System are essentially determined by the timeresolution capabilities of its optical timing receiver. The optical timing receiver consists of a fast photoelectric device; (e.g., photomultiplier or an avalanche photodiode detector), a timing discriminator, a high-precision event-timing digitizer, and a signal-processing system. The time-resolution capabilities of the receiver are determined by the photoelectron time spread of the photoelectric device, the time walk and resolution characteristics of the timing discriminator, and the resolution of the event-timing digitizer. It is thus necessary to evaluate available fast photoelectronic devices with respect to the time-resolution capabilities, and to develop a very low time walk timing discriminator and a high-resolution event-timing digitizer to be used in the high-resolution spaceborne laser ranging system receiver. This part of the report describes the development of a high precision event-timing digitizer. The event-timing digitizer is basically a combination of a very accurate high resolution real time digital clock and an interval timer. The timing digitizer is a high resolution multiple stop clock, counting the time up to 131 days in 19.5 ps increments.

  2. Financial system loss as an example of high consequence, high frequency events

    Energy Technology Data Exchange (ETDEWEB)

    McGovern, D.E.

    1996-07-01

    Much work has been devoted to high consequence events with low frequency of occurrence. Characteristic of these events are bridge failure (such as that of the Tacoma Narrows), building failure (such as the collapse of a walkway at a Kansas City hotel), or compromise of a major chemical containment system (such as at Bhopal, India). Such events, although rare, have an extreme personal, societal, and financial impact. An interesting variation is demonstrated by financial losses due to fraud and abuse in the money management system. The impact can be huge, entailing very high aggregate costs, but these are a result of the contribution of many small attacks and not the result of a single (or few) massive events. Public awareness is raised through publicized events such as the junk bond fraud perpetrated by Milikin or gross mismanagement in the failure of the Barings Bank through unsupervised trading activities by Leeson in Singapore. These event,s although seemingly large (financial losses may be on the order of several billion dollars), are but small contributors to the estimated $114 billion loss to all types of financial fraud in 1993. This paper explores the magnitude of financial system losses and identifies new areas for analysis of high consequence events including the potential effect of malevolent intent.

  3. A behavioral framework for compositionality: linear systems, discrete event systems and hybrid systems

    NARCIS (Netherlands)

    Anak Agung Julius, A.A.J.; van der Schaft, Arjan

    2004-01-01

    In this paper we formulate a general framework based on the behavioral approach to dynamical systems, in which various issues regarding interconnection of systems can be addressed. The main part of the framework is that interconnections or compositions of systems can be modelled with interconnection

  4. The complexity of patient safety reporting systems in UK dentistry.

    Science.gov (United States)

    Renton, T; Master, S

    2016-10-21

    Since the 'Francis Report', UK regulation focusing on patient safety has significantly changed. Healthcare workers are increasingly involved in NHS England patient safety initiatives aimed at improving reporting and learning from patient safety incidents (PSIs). Unfortunately, dentistry remains 'isolated' from these main events and continues to have a poor record for reporting and learning from PSIs and other events, thus limiting improvement of patient safety in dentistry. The reasons for this situation are complex.This paper provides a review of the complexities of the existing systems and procedures in relation to patient safety in dentistry. It highlights the conflicting advice which is available and which further complicates an overly burdensome process. Recommendations are made to address these problems with systems and procedures supporting patient safety development in dentistry.

  5. Seabed resident event driven profiling system (SREP). Concept, design and tests

    Digital Repository Service at National Institute of Oceanography (India)

    Mascarenhas, A.A.M.Q.; Afzulpurkar, S.; Maurya, P.K.; Fernandes, L.; Madhan, R.; Desa, E.S.; Dabolkar, N.A.; Navelkar, G.S.; Naik, L.; Shetye, V.G.; Shetty, N.B.; Prabhudesai, S.P.; Nagvekar, S.; Vimalakumari, D.

    The seabed resident event driven profiling system (SREP) described here offers a novel, optimized approach to profiling in coastal waters from seabed to sea surface during the rough seas encountered in the southwest monsoon season (June...

  6. Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial

    International Nuclear Information System (INIS)

    Basch, Ethan; Pugh, Stephanie L.; Dueck, Amylou C.; Mitchell, Sandra A.; Berk, Lawrence; Fogh, Shannon; Rogak, Lauren J.; Gatewood, Marcha; Reeve, Bryce B.; Mendoza, Tito R.; O'Mara, Ann M.; Denicoff, Andrea M.; Minasian, Lori M.; Bennett, Antonia V.; Setser, Ann; Schrag, Deborah

    2017-01-01

    Purpose: To assess the feasibility of measuring symptomatic adverse events (AEs) in a multicenter clinical trial using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Methods and Materials: Patients enrolled in NRG Oncology's RTOG 1012 (Prophylactic Manuka Honey for Reduction of Chemoradiation Induced Esophagitis-Related Pain during Treatment of Lung Cancer) were asked to self-report 53 PRO-CTCAE items representing 30 symptomatic AEs at 6 time points (baseline; weekly ×4 during treatment; 12 weeks after treatment). Reporting was conducted via wireless tablet computers in clinic waiting areas. Compliance was defined as the proportion of visits when an expected PRO-CTCAE assessment was completed. Results: Among 226 study sites participating in RTOG 1012, 100% completed 35-minute PRO-CTCAE training for clinical research associates (CRAs); 80 sites enrolled patients, of which 34 (43%) required tablet computers to be provided. All 152 patients in RTOG 1012 agreed to self-report using the PRO-CTCAE (median age 66 years; 47% female; 84% white). Median time for CRAs to learn the system was 60 minutes (range, 30-240 minutes), and median time for CRAs to teach a patient to self-report was 10 minutes (range, 2-60 minutes). Compliance was high, particularly during active treatment, when patients self-reported at 86% of expected time points, although compliance was lower after treatment (72%). Common reasons for noncompliance were institutional errors, such as forgetting to provide computers to participants; patients missing clinic visits; Internet connectivity; and patients feeling “too sick.” Conclusions: Most patients enrolled in a multicenter chemoradiotherapy trial were willing and able to self-report symptomatic AEs at visits using tablet computers. Minimal effort was required by local site staff to support this system. The observed causes of missing data may be obviated by

  7. Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Basch, Ethan, E-mail: ebasch@med.unc.edu [Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York (United States); Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina (United States); Pugh, Stephanie L. [NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania (United States); Dueck, Amylou C. [Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, Arizona (United States); Mitchell, Sandra A. [Division of Cancer Control and Population Sciences, Outcomes Research Branch, National Cancer Institute, Rockville, Maryland (United States); Berk, Lawrence [Radiation Oncology, University of South Florida, Tampa, Florida (United States); Fogh, Shannon [Department of Radiation Oncology, University of California, San Francisco, San Francisco, California (United States); Rogak, Lauren J. [Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York (United States); Gatewood, Marcha [Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia (United States); Reeve, Bryce B. [Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina (United States); Mendoza, Tito R. [Department of Symptom Research, The University of Texas MD. Anderson Cancer Center, Houston, Texas (United States); O' Mara, Ann M.; Denicoff, Andrea M.; Minasian, Lori M. [Division of Cancer Control and Population Sciences, Outcomes Research Branch, National Cancer Institute, Rockville, Maryland (United States); Bennett, Antonia V. [Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina (United States); Setser, Ann [Setser Health Consulting, LLC, St. Louis, Missouri (United States); Schrag, Deborah [Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts (United States); and others

    2017-06-01

    Purpose: To assess the feasibility of measuring symptomatic adverse events (AEs) in a multicenter clinical trial using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Methods and Materials: Patients enrolled in NRG Oncology's RTOG 1012 (Prophylactic Manuka Honey for Reduction of Chemoradiation Induced Esophagitis-Related Pain during Treatment of Lung Cancer) were asked to self-report 53 PRO-CTCAE items representing 30 symptomatic AEs at 6 time points (baseline; weekly ×4 during treatment; 12 weeks after treatment). Reporting was conducted via wireless tablet computers in clinic waiting areas. Compliance was defined as the proportion of visits when an expected PRO-CTCAE assessment was completed. Results: Among 226 study sites participating in RTOG 1012, 100% completed 35-minute PRO-CTCAE training for clinical research associates (CRAs); 80 sites enrolled patients, of which 34 (43%) required tablet computers to be provided. All 152 patients in RTOG 1012 agreed to self-report using the PRO-CTCAE (median age 66 years; 47% female; 84% white). Median time for CRAs to learn the system was 60 minutes (range, 30-240 minutes), and median time for CRAs to teach a patient to self-report was 10 minutes (range, 2-60 minutes). Compliance was high, particularly during active treatment, when patients self-reported at 86% of expected time points, although compliance was lower after treatment (72%). Common reasons for noncompliance were institutional errors, such as forgetting to provide computers to participants; patients missing clinic visits; Internet connectivity; and patients feeling “too sick.” Conclusions: Most patients enrolled in a multicenter chemoradiotherapy trial were willing and able to self-report symptomatic AEs at visits using tablet computers. Minimal effort was required by local site staff to support this system. The observed causes of missing data may be

  8. 77 FR 22322 - Common Formats for Patient Safety Data Collection and Event Reporting

    Science.gov (United States)

    2012-04-13

    ... safety reporting systems. This inventory provides an evidence base that informs construction of the Common Formats. The inventory includes many systems from the private sector, including prominent academic... HHS Web site: http://www.PSO.AHRQ.gov/index.html . FOR FURTHER INFORMATION CONTACT: Cathryn Niane...

  9. Contributions to dataflow sub-system of the ATLAS data acquisition and event filter prototype-1 project

    International Nuclear Information System (INIS)

    Badescu, E.; Caprini, M.; Niculescu, M.; Radu, A.

    1998-01-01

    implementation of the ROB some test programs were developed and a bunch of performance measurements have been done. The high level design of the local DAQ (LDAQ) was done followed by the initial implementation of the LDAQ of the ROC. The minimal set of functions provided by the LDAQ includes: - Local control within the dataflow, both to control a data taking session and to deal with errors produced during the data taking session (it is the integration element in the ROC); - Support for event monitoring programs: a statistical sample of the events flowing in the ROC has to be provided to user programs for analysis/monitoring purposes; - Access to configuration data bases: the dataflow system configuration and the dataflow parameters will be retrieved from the data base; - Interface to back-end: LDAQ is the point in the dataflow system which connects the ROC to the back-end system for run control, the configuration database, the Message Reporting System and the Information Service; - Stand alone operation: the LDAQ will also provide the facility to run a dataflow building clock, such a single ROC, in stand alone mode (e.g. for debugging purposes). (authors)

  10. Single event monitoring system based on Java 3D and XML data binding

    International Nuclear Information System (INIS)

    Wang Liang; Chinese Academy of Sciences, Beijing; Zhu Kejun; Zhao Jingwei

    2007-01-01

    Online single event monitoring is important to BESIII DAQ System. Java3D is extension of Java Language in 3D technology, XML data binding is more efficient to handle XML document than SAX and DOM. This paper mainly introduce the implementation of BESIII single event monitoring system with Java3D and XML data binding, and interface for track fitting software with JNI technology. (authors)

  11. Evidence Report: Risk of Crew Adverse Health Event Due to Altered Immune Response

    Science.gov (United States)

    Crucian, Brian; Sams, Clarence F.

    2013-01-01

    The Risk of Crew Adverse Health Event Due to Altered Immune Response is identified by the National Aeronautics and Space Administration (NASA) Human Research Program (HRP) as a recognized risk to human health and performance in space. The HRP Program Requirements Document (PRD) defines these risks. This Evidence Report provides a summary of the evidence that has been used to identify and characterize this risk. It is known that human immune function is altered in- and post-flight, but it is unclear at present if such alterations lead to increased susceptibility to disease. Reactivation of latent viruses has been documented in crewmembers, although this reactivation has not been directly correlated with immune changes or with observed diseases. As described in this report, further research is required to better characterize the relationships between altered immune response and susceptibility to disease during and after spaceflight. This is particularly important for future deep-space exploration missions.

  12. Tank waste remediation system mission analysis report

    International Nuclear Information System (INIS)

    Acree, C.D.

    1998-01-01

    The Tank Waste Remediation System Mission Analysis Report identifies the initial states of the system and the desired final states of the system. The Mission Analysis Report identifies target measures of success appropriate to program-level accomplishments. It also identifies program-level requirements and major system boundaries and interfaces

  13. Event-Driven Control for Networked Control Systems With Quantization and Markov Packet Losses.

    Science.gov (United States)

    Yang, Hongjiu; Xu, Yang; Zhang, Jinhui

    2016-05-23

    In this paper, event-driven is used in a networked control system (NCS) which is subjected to the effect of quantization and packet losses. A discrete event-detector is used to monitor specific events in the NCS. Both an arbitrary region quantizer and Markov jump packet losses are also considered for the NCS. Based on zoom strategy and Lyapunov theory, a complete proof is given to guarantee mean square stability of the closed-loop system. Stabilization of the NCS is ensured by designing a feedback controller. Lastly, an inverted pendulum model is given to show the advantages and effectiveness of the proposed results.

  14. Choosing Appropriate Theories for Understanding Hospital Reporting of Adverse Drug Events, a Theoretical Domains Framework Approach.

    Science.gov (United States)

    Shalviri, Gloria; Yazdizadeh, Bahareh; Mirbaha, Fariba; Gholami, Kheirollah; Majdzadeh, Reza

    2018-01-01

    Adverse drug events (ADEs) may cause serious injuries including death. Spontaneous reporting of ADEs plays a great role in detection and prevention of them; however, underreporting always exists. Although several interventions have been utilized to solve this problem, they are mainly based on experience and the rationale for choosing them has no theoretical base. The vast variety of behavioural theories makes it difficult to choose appropriate theory. Theoretical domains framework (TDF) is suggested as a solution. The objective of this study was to select the best theory for evaluating ADE reporting in hospitals based on TDF. We carried out three focus group discussions with hospital pharmacists and nurses, based on TDF questions. The analysis was performed through five steps including coding discussions transcript, extracting beliefs, selecting relevant domains, matching related constructs to the extracted beliefs, and determining the appropriate theories in each domain. The theory with the highest number of matched domains and constructs was selected as the theory of choice. A total of six domains were identified relevant to ADE reporting, including "Knowledge", "Skills", "Beliefs about consequences", "Motivation and goals", "Environmental context and resources" and "Social influences". We found theory of planned behavior as the comprehensive theory to study factors influencing ADE reporting in hospitals, since it was relevant theory in five out of six relevant domains and the common theory in 55 out of 75 identified beliefs. In conclusion, we suggest theory of planned behavior for further studies on designing appropriate interventions to increase ADE reporting in hospitals.

  15. An integrated logit model for contamination event detection in water distribution systems.

    Science.gov (United States)

    Housh, Mashor; Ostfeld, Avi

    2015-05-15

    The problem of contamination event detection in water distribution systems has become one of the most challenging research topics in water distribution systems analysis. Current attempts for event detection utilize a variety of approaches including statistical, heuristics, machine learning, and optimization methods. Several existing event detection systems share a common feature in which alarms are obtained separately for each of the water quality indicators. Unifying those single alarms from different indicators is usually performed by means of simple heuristics. A salient feature of the current developed approach is using a statistically oriented model for discrete choice prediction which is estimated using the maximum likelihood method for integrating the single alarms. The discrete choice model is jointly calibrated with other components of the event detection system framework in a training data set using genetic algorithms. The fusing process of each indicator probabilities, which is left out of focus in many existing event detection system models, is confirmed to be a crucial part of the system which could be modelled by exploiting a discrete choice model for improving its performance. The developed methodology is tested on real water quality data, showing improved performances in decreasing the number of false positive alarms and in its ability to detect events with higher probabilities, compared to previous studies. Copyright © 2015 Elsevier Ltd. All rights reserved.

  16. Ultra-Low Power Sensor System for Disaster Event Detection in Metro Tunnel Systems

    Directory of Open Access Journals (Sweden)

    Jonah VINCKE

    2017-05-01

    Full Text Available In this extended paper, the concept for an ultra-low power wireless sensor network (WSN for underground tunnel systems is presented highlighting the chosen sensors. Its objectives are the detection of emergency events either from natural disasters, such as flooding or fire, or from terrorist attacks using explosives. Earlier works have demonstrated that the power consumption for the communication can be reduced such that the data acquisition (i.e. sensor sub-system becomes the most significant energy consumer. By using ultra-low power components for the smoke detector, a hydrostatic pressure sensor for water ingress detection and a passive acoustic emission sensor for explosion detection, all considered threats are covered while the energy consumption can be kept very low in relation to the data acquisition. In addition to 1 the sensor system is integrated into a sensor board. The total average power consumption for operating the sensor sub-system is measured to be 35.9 µW for lower and 7.8 µW for upper nodes.

  17. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder

    DEFF Research Database (Denmark)

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn

    2014-01-01

    OBJECTIVE: To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. DESIGN: Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events...... identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report. SETTING: 9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted to the European Medicines Agency...... for marketing approval. DATA SOURCES: Clinical study reports obtained from the EMA in 2011. RESULTS: Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly...

  18. Control of Discrete-Event Systems Automata and Petri Net Perspectives

    CERN Document Server

    Silva, Manuel; Schuppen, Jan

    2013-01-01

    Control of Discrete-event Systems provides a survey of the most important topics in the discrete-event systems theory with particular focus on finite-state automata, Petri nets and max-plus algebra. Coverage ranges from introductory material on the basic notions and definitions of discrete-event systems to more recent results. Special attention is given to results on supervisory control, state estimation and fault diagnosis of both centralized and distributed/decentralized systems developed in the framework of the Distributed Supervisory Control of Large Plants (DISC) project. Later parts of the text are devoted to the study of congested systems though fluidization, an over approximation allowing a much more efficient study of observation and control problems of timed Petri nets. Finally, the max-plus algebraic approach to the analysis and control of choice-free systems is also considered. Control of Discrete-event Systems provides an introduction to discrete-event systems for readers that are not familiar wi...

  19. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis.

    Directory of Open Access Journals (Sweden)

    Jeppe Bennekou Schroll

    2016-08-01

    Full Text Available Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials.We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were "bothersome," a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal, which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc filters, though six of

  20. Studies on switch-based event building systems in RD13

    International Nuclear Information System (INIS)

    Bee, C.P.; Eshghi, S.; Jones, R.

    1996-01-01

    One of the goals of the RD13 project at CERN is to investigate the feasibility of parallel event building system for detectors at the LHC. Studies were performed by building a prototype based on the HiPPI standard and by modeling this prototype and extended architectures with MODSIM II. The prototype used commercially available VME-HiPPI interfaces and a HiPPI switch together with a modular software. The setup was tested successfully as a parallel event building system in different configurations and with different data flow control schemes. The simulation program was used with realistic parameters from the prototype measurements to simulate large-scale event building systems. This includes simulations of a realistic setup of the ATLAS event building system. The influence of different parameters and scaling behavior were investigated. The influence of realistic event size distributions was checked with data from off-line simulations. Different control schemes for destination assignment and traffic shaping were investigated as well as a two-stage event building system. (author)

  1. The influence of international and domestic events in the evolution of forest inventory and reporting consistency in the United States

    Science.gov (United States)

    W. Brad Smith

    2009-01-01

    This article takes a brief chronological look at resource inventory and reporting and links to international influences. It explores events as drivers of more consistent data within the United States and highlights key dates and events in the evolution of inventory policy and practice. From King George to L?Ecole nationale forestiere to the Food and Agriculture...

  2. A coupled classification - evolutionary optimization model for contamination event detection in water distribution systems.

    Science.gov (United States)

    Oliker, Nurit; Ostfeld, Avi

    2014-03-15

    This study describes a decision support system, alerts for contamination events in water distribution