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

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

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.

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

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.

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.

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

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.

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

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

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.

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

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

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

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.

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.

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

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

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

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

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

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.

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

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.

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.

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

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.

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

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.

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.

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.

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

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

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.

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

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)

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

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

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

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

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

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.

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.

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)

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.

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

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...

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

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...

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

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.

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.

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.

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

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.

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)

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.

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

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.

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.

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

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.

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.

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.

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.

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.

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

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.

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)

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.

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.

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

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

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.

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.

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.

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.

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.

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

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.

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

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...

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

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.

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

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

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

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)

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)

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

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.

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

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.

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).

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)

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.

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

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)

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.

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.

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.

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.

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

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.

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.

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.

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.

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

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)

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.

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.

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.

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

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

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

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

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...

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

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

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.

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...

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.

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)

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

Features, Events, and Processes: Disruptive Events

Energy Technology Data Exchange (ETDEWEB)

J. King

2004-03-31

The primary purpose of this analysis is to evaluate seismic- and igneous-related features, events, and processes (FEPs). These FEPs represent areas of natural system processes that have the potential to produce disruptive events (DE) that could impact repository performance and are related to the geologic processes of tectonism, structural deformation, seismicity, and igneous activity. Collectively, they are referred to as the DE FEPs. This evaluation determines which of the DE FEPs are excluded from modeling used to support the total system performance assessment for license application (TSPA-LA). The evaluation is based on the data and results presented in supporting analysis reports, model reports, technical information, or corroborative documents that are cited in the individual FEP discussions in Section 6.2 of this analysis report.

Features, Events, and Processes: Disruptive Events

International Nuclear Information System (INIS)

J. King

2004-01-01

The primary purpose of this analysis is to evaluate seismic- and igneous-related features, events, and processes (FEPs). These FEPs represent areas of natural system processes that have the potential to produce disruptive events (DE) that could impact repository performance and are related to the geologic processes of tectonism, structural deformation, seismicity, and igneous activity. Collectively, they are referred to as the DE FEPs. This evaluation determines which of the DE FEPs are excluded from modeling used to support the total system performance assessment for license application (TSPA-LA). The evaluation is based on the data and results presented in supporting analysis reports, model reports, technical information, or corroborative documents that are cited in the individual FEP discussions in Section 6.2 of this analysis report

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

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.

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.

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.

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.

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

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

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

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

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.

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...

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

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.…

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.

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...

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

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.

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

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.

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

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.

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

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.

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 ...

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.

Features, Events, and Processes: Disruptive Events

International Nuclear Information System (INIS)

P. Sanchez

2004-01-01

The purpose of this analysis report is to evaluate and document the inclusion or exclusion of the disruptive events features, events, and processes (FEPs) with respect to modeling used to support the total system performance assessment for 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 63.114 (d), (e), and (f) [DIRS 156605]. The FEPs addressed in this report deal with both seismic and igneous disruptive events, such as fault displacements through the repository and an igneous intrusion into the repository. For included FEPs, this analysis summarizes the implementation of the FEP in 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). Previous versions of this report were developed to support the total system performance assessments (TSPA) for various prior repository designs. This revision addresses the repository design for the license application (LA)

Features, Events, and Processes: Disruptive Events

Energy Technology Data Exchange (ETDEWEB)

P. Sanchez

2004-11-08

The purpose of this analysis report is to evaluate and document the inclusion or exclusion of the disruptive events features, events, and processes (FEPs) with respect to modeling used to support the total system performance assessment for 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 63.114 (d), (e), and (f) [DIRS 156605]. The FEPs addressed in this report deal with both seismic and igneous disruptive events, such as fault displacements through the repository and an igneous intrusion into the repository. For included FEPs, this analysis summarizes the implementation of the FEP in 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). Previous versions of this report were developed to support the total system performance assessments (TSPA) for various prior repository designs. This revision addresses the repository design for the license application (LA).

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

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.

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.

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

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...

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.

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

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.

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.

NPP unusual events: data, analysis and application

International Nuclear Information System (INIS)

Tolstykh, V.

1990-01-01

Subject of the paper are the IAEA cooperative patterns of unusual events data treatment and utilization of the operating safety experience feedback. The Incident Reporting System (IRS) and the Analysis of Safety Significant Event Team (ASSET) are discussed. The IRS methodology in collection, handling, assessment and dissemination of data on NPP unusual events (deviations, incidents and accidents) occurring during operations, surveillance and maintenance is outlined by the reports gathering and issuing practice, the experts assessment procedures and the parameters of the system. After 7 years of existence the IAEA-IRS contains over 1000 reports and receives 1.5-4% of the total information on unusual events. The author considers the reports only as detailed technical 'records' of events requiring assessment. The ASSET approaches implying an in-depth occurrences analysis directed towards level-1 PSA utilization are commented on. The experts evaluated root causes for the reported events and some trends are presented. Generally, internal events due to unexpected paths of water in the nuclear installations, occurrences related to the integrity of the primary heat transport systems, events associated with the engineered safety systems and events involving human factor represent the large groups deserving close attention. Personal recommendations on how to use the events related information use for NPP safety improvement are given. 2 tabs (R.Ts)

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

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.

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.

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.

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.

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.

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

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

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.

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)

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.)

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.

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

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.

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.

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

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

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

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.

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.

[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.

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.

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)

Recurring events - Volume 2

International Nuclear Information System (INIS)

2003-04-01

The feedback of operating experience from nuclear power plants (NPP) is intended to help avoid occurrence or recurrence of safety significant events. Regulatory bodies, and utilities operating nuclear power plants, have established operating experience feedback systems since the beginning of commercial nuclear power production. Well-established operating experience feedback systems exist on national and international level. An example of an international system is the Incident Reporting System (IRS) jointly operated by the International Atomic Energy Agency (IAEA) and the Nuclear Energy Agency (NEA). There also are systems maintained by the operating organizations, including the World Association of Nuclear Operators (WANO), and owner groups of different NPP vendors. Committee on the Safety of Nuclear Installations (CSNI) Working Group on Operating Experience (WGOE; formerly Principal Working Group No. 1, PWG1) carried out a study on recurring events some years ago. This report, published in 1999, highlighted some areas of safety significance involving recurrent events in different NPPs around the world. Based on the important findings of this report, CSNI requested two additional studies: 1. first an international workshop should be organized and second, 2. a task group should be established to develop a second report on the topic and to evaluate the findings of the workshop. The workshop, hosted by the Swiss Regulatory Authority, HSK, was held in Switzerland in March 2002. It was attended by 32 experts representing the regulatory, nuclear power plant, vendor, and international agency communities. Several insights and recommendations were presented and are integrated in this report with respect to causes of recurring events: - Operating experience feedback processes had not always been effective, that is, the existing operating experiences had not been effectively applied, - Actions to be taken were not implemented in a timely manner, - The root cause was not

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

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.

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

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...

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.

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

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.

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.

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

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

Contributory factors in surgical incidents as delineated by a confidential reporting system.

Science.gov (United States)

Mushtaq, F; O'Driscoll, C; Smith, Fct; Wilkins, D; Kapur, N; Lawton, R

2018-05-01

Background Confidential reporting systems play a key role in capturing information about adverse surgical events. However, the value of these systems is limited if the reports that are generated are not subjected to systematic analysis. The aim of this study was to provide the first systematic analysis of data from a novel surgical confidential reporting system to delineate contributory factors in surgical incidents and document lessons that can be learned. Methods One-hundred and forty-five patient safety incidents submitted to the UK Confidential Reporting System for Surgery over a 10-year period were analysed using an adapted version of the empirically-grounded Yorkshire Contributory Factors Framework. Results The most common factors identified as contributing to reported surgical incidents were cognitive limitations (30.09%), communication failures (16.11%) and a lack of adherence to established policies and procedures (8.81%). The analysis also revealed that adverse events were only rarely related to an isolated, single factor (20.71%) - with the majority of cases involving multiple contributory factors (79.29% of all cases had more than one contributory factor). Examination of active failures - those closest in time and space to the adverse event - pointed to frequent coupling with latent, systems-related contributory factors. Conclusions Specific patterns of errors often underlie surgical adverse events and may therefore be amenable to targeted intervention, including particular forms of training. The findings in this paper confirm the view that surgical errors tend to be multi-factorial in nature, which also necessitates a multi-disciplinary and system-wide approach to bringing about improvements.

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.

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.

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...

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

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.

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).

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.

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

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.

Surface Movement Incidents Reported to the NASA Aviation Safety Reporting System

Science.gov (United States)

Connell, Linda J.; Hubener, Simone

1997-01-01

Increasing numbers of aircraft are operating on the surface of airports throughout the world. Airport operations are forecast to grow by more that 50%, by the year 2005. Airport surface movement traffic would therefore be expected to become increasingly congested. Safety of these surface operations will become a focus as airport capacity planning efforts proceed toward the future. Several past events highlight the prevailing risks experienced while moving aircraft during ground operations on runways, taxiways, and other areas at terminal, gates, and ramps. The 1994 St. Louis accident between a taxiing Cessna crossing an active runway and colliding with a landing MD-80 emphasizes the importance of a fail-safe system for airport operations. The following study explores reports of incidents occurring on an airport surface that did not escalate to an accident event. The Aviation Safety Reporting System has collected data on surface movement incidents since 1976. This study sampled the reporting data from June, 1993 through June, 1994. The coding of the data was accomplished in several categories. The categories include location of airport, phase of ground operation, weather /lighting conditions, ground conflicts, flight crew characteristics, human factor considerations, and airport environment. These comparisons and distributions of variables contributing to surface movement incidents can be invaluable to future airport planning, accident prevention efforts, and system-wide improvements.

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)

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.

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

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.

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

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

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)

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. ...

Negated bio-events: analysis and identification

Science.gov (United States)

2013-01-01

Background Negation occurs frequently in scientific literature, especially in biomedical literature. It has previously been reported that around 13% of sentences found in biomedical research articles contain negation. Historically, the main motivation for identifying negated events has been to ensure their exclusion from lists of extracted interactions. However, recently, there has been a growing interest in negative results, which has resulted in negation detection being identified as a key challenge in biomedical relation extraction. In this article, we focus on the problem of identifying negated bio-events, given gold standard event annotations. Results We have conducted a detailed analysis of three open access bio-event corpora containing negation information (i.e., GENIA Event, BioInfer and BioNLP’09 ST), and have identified the main types of negated bio-events. We have analysed the key aspects of a machine learning solution to the problem of detecting negated events, including selection of negation cues, feature engineering and the choice of learning algorithm. Combining the best solutions for each aspect of the problem, we propose a novel framework for the identification of negated bio-events. We have evaluated our system on each of the three open access corpora mentioned above. The performance of the system significantly surpasses the best results previously reported on the BioNLP’09 ST corpus, and achieves even better results on the GENIA Event and BioInfer corpora, both of which contain more varied and complex events. Conclusions Recently, in the field of biomedical text mining, the development and enhancement of event-based systems has received significant interest. The ability to identify negated events is a key performance element for these systems. We have conducted the first detailed study on the analysis and identification of negated bio-events. Our proposed framework can be integrated with state-of-the-art event extraction systems. The

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.

Adverse events associated with pediatric exposures to dextromethorphan.

Science.gov (United States)

Paul, Ian M; Reynolds, Kate M; Kauffman, Ralph E; Banner, William; Bond, G Randall; Palmer, Robert B; Burnham, Randy I; Green, Jody L

2017-01-01

Dextromethorphan is the most common over-the-counter (OTC) antitussive medication. We sought to characterize adverse events associated with dextromethorphan in children dextromethorphan with ≥1 adverse event from multiple U.S. sources (National Poison Data System, FDA Adverse Event Reporting System, manufacturer safety reports, news/media, medical literature) reported between 2008 and 2014. An expert panel determined the relationship between exposure and adverse events, estimated dose ingested, intent of exposure, and identified contributing factors to exposure. 1716 cases contained ≥1 adverse event deemed at least potentially related to dextromethorphan; 1417 were single product exposures. 773/1417 (55%) involved only one single-ingredient dextromethorphan product (dextromethorphan-only). Among dextromethorphan-only cases, 3% followed ingestion of a therapeutic dose; 78% followed an overdose. 69% involved unsupervised self-administration and 60% occurred in children dextromethorphan-only ingestion. Adverse events were predominantly associated with overdose, most commonly affecting the central nervous and autonomic systems.

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...

Nuclear power plant operating experiences from the IAEA/NEA Incident Reporting System 1999-2002

International Nuclear Information System (INIS)

2003-01-01

Incident reporting has become an increasingly important aspect of the operation and regulation of all public health and safety-related industries. Diverse industries such as aeronautics, chemicals, pharmaceuticals and explosives all depend on operating experience feedback to provide lessons learned about safety. The Incident Reporting System (IRS) is an essential element of the system for feeding back international operating experience for nuclear power plants. IRS reports contain information on events of Safety significance with important lessons learned. These experiences assist in reducing or eliminating recurrence of events at other plants. The IRS is jointly operated and managed by the Nuclear Energy Agency (NEA), a semi-autonomous body within the Organisation for Economic Co-operation and Development (OECD), and the International Atomic Energy Agency (IAEA). It is important that sufficient national resources be allocated to enable timely and high quality reporting of events important to safety, and to share these events in the IRS database. The first report, which covered the period July 1996 - June 1999, was widely acclaimed and encouraged both agencies to prepare this second report in order to highlight important lessons learned from around 300 events reported to the IRS for the period July 1999 - December 2002. Several areas were selected in this report to show the range of important topics available in the IRS. These include different types of failure in a variety of plant systems, as well as human performance considerations. This report is primarily aimed at senior officials in industry and government who have decision-making roles in the nuclear power industry

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.

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.

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.

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)

Review of events at large pool-type irradiators

International Nuclear Information System (INIS)

Trager, E.A. Jr.

1989-03-01

Large pool-type gamma irradiators are used in applications such as the ''cold'' sterilization of medical and pharmaceutical supplies, and recent changes in federal regulations make it possible they will be used extensively in the preservation of foodstuffs. Because of this possible large increase in the use of irradiators, the Office of Nuclear Materials Safety and Safeguards was interested in knowing what events had occurred at irradiators. The event data would be used as background in developing new regulations on irradiators. Therefore, AEOD began a study of the operating experience at large, wet source storage gamma irradiators. The scope of the study was to assess all available operating information on large (≥ 250,000 curie), pool-type irradiators licensed by both the NRC and the Agreement States, and events at foreign facilities. The study found that about 0.12 events have been reported per irradiator-year. Most of these events were precursor events, in that there was no evidence of damage to the radioactive sources or degradation in the level of safety of the facility. Events with more significant impacts had a reported frequency of about 0.01 event per irradiator-year. However, the actual rate of occurrence of events of concern to the staff may be higher because there are few specific reporting requirements for events at irradiators. It is suggested that during development of a regulation for large pool-type irradiators consideration be given to specifying requirements for: reporting breakdowns in access control systems; periodic inspection of the source movement and suspension system; systems to detect source leakage and product contamination; allowable pool leakage; and feedback of information on operational events involving safety-important systems

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.

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

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

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

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

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

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.

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

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

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

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

Science.gov (United States)

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

2006-11-27

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

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.

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.

SU-E-T-524: Web-Based Radiation Oncology Incident Reporting and Learning System (ROIRLS)

Energy Technology Data Exchange (ETDEWEB)

Kapoor, R; Palta, J; Hagan, M [Virginia Commonwealth University, Richmond, VA (United States); National Radiation Oncology Program (10P4H), Richmond, VA (United States); Grover, S; Malik, G [TSG Innovations Inc., Richmond, VA (United States)

2014-06-01

Purpose: Describe a Web-based Radiation Oncology Incident Reporting and Learning system that has the potential to improve quality of care for radiation therapy patients. This system is an important facet of continuing effort by our community to maintain and improve safety of radiotherapy.Material and Methods: The VA National Radiation Oncology Program office has embarked on a program to electronically collect adverse events and near miss data of radiation treatment of over 25,000 veterans treated with radiotherapy annually. Software used for this program is deployed on the VAs intranet as a Website. All data entry forms (adverse event or near miss reports, work product reports) utilize standard causal, RT process step taxonomies and data dictionaries defined in AAPM and ASTRO reports on error reporting (AAPM Work Group Report on Prevention of Errors and ASTROs safety is no accident report). All reported incidents are investigated by the radiation oncology domain experts. This system encompasses the entire feedback loop of reporting an incident, analyzing it for salient details, and developing interventions to prevent it from happening again. The operational workflow is similar to that of the Aviation Safety Reporting System. This system is also synergistic with ROSIS and SAFRON. Results: The ROIRLS facilitates the collection of data that help in tracking adverse events and near misses and develop new interventions to prevent such incidents. The ROIRLS electronic infrastructure is fully integrated with each registered facility profile data thus minimizing key strokes and multiple entries by the event reporters. Conclusions: OIRLS is expected to improve the quality and safety of a broad spectrum of radiation therapy patients treated in the VA and fulfills our goal of Effecting Quality While Treating Safely The Radiation Oncology Incident Reporting and Learning System software used for this program has been developed, conceptualized and maintained by TSG Innovations

SU-E-T-524: Web-Based Radiation Oncology Incident Reporting and Learning System (ROIRLS)

International Nuclear Information System (INIS)

Kapoor, R; Palta, J; Hagan, M; Grover, S; Malik, G

2014-01-01

Purpose: Describe a Web-based Radiation Oncology Incident Reporting and Learning system that has the potential to improve quality of care for radiation therapy patients. This system is an important facet of continuing effort by our community to maintain and improve safety of radiotherapy.Material and Methods: The VA National Radiation Oncology Program office has embarked on a program to electronically collect adverse events and near miss data of radiation treatment of over 25,000 veterans treated with radiotherapy annually. Software used for this program is deployed on the VAs intranet as a Website. All data entry forms (adverse event or near miss reports, work product reports) utilize standard causal, RT process step taxonomies and data dictionaries defined in AAPM and ASTRO reports on error reporting (AAPM Work Group Report on Prevention of Errors and ASTROs safety is no accident report). All reported incidents are investigated by the radiation oncology domain experts. This system encompasses the entire feedback loop of reporting an incident, analyzing it for salient details, and developing interventions to prevent it from happening again. The operational workflow is similar to that of the Aviation Safety Reporting System. This system is also synergistic with ROSIS and SAFRON. Results: The ROIRLS facilitates the collection of data that help in tracking adverse events and near misses and develop new interventions to prevent such incidents. The ROIRLS electronic infrastructure is fully integrated with each registered facility profile data thus minimizing key strokes and multiple entries by the event reporters. Conclusions: OIRLS is expected to improve the quality and safety of a broad spectrum of radiation therapy patients treated in the VA and fulfills our goal of Effecting Quality While Treating Safely The Radiation Oncology Incident Reporting and Learning System software used for this program has been developed, conceptualized and maintained by TSG Innovations

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

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.

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.

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

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

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

Twitter web-service for soft agent reporting in persistent surveillance systems

Science.gov (United States)

Rababaah, Haroun; Shirkhodaie, Amir

2010-04-01

Persistent surveillance is an intricate process requiring monitoring, gathering, processing, tracking, and characterization of many spatiotemporal events occurring concurrently. Data associated with events can be readily attained by networking of hard (physical) sensors. Sensors may have homogeneous or heterogeneous (hybrid) sensing modalities with different communication bandwidth requirements. Complimentary to hard sensors are human observers or "soft sensors" that can report occurrences of evolving events via different communication devices (e.g., texting, cell phones, emails, instant messaging, etc.) to the command control center. However, networking of human observers in ad-hoc way is rather a difficult task. In this paper, we present a Twitter web-service for soft agent reporting in persistent surveillance systems (called Web-STARS). The objective of this web-service is to aggregate multi-source human observations in hybrid sensor networks rapidly. With availability of Twitter social network, such a human networking concept can not only be realized for large scale persistent surveillance systems (PSS), but also, it can be employed with proper interfaces to expedite rapid events reporting by human observers. The proposed technique is particularly suitable for large-scale persistent surveillance systems with distributed soft and hard sensor networks. The efficiency and effectiveness of the proposed technique is measured experimentally by conducting several simulated persistent surveillance scenarios. It is demonstrated that by fusion of information from hard and soft agents improves understanding of common operating picture and enhances situational awareness.

Technical assistance contractor occurrence reporting and processing system

International Nuclear Information System (INIS)

1996-08-01

Members of the Uranium Mill Tailings Remedial Action (UMTRA) Project Technical Assistance Contractor (TAC) are responsible to notify management of TAC occurrence reporting and processing system (ORPS) classified occurrences .An ORPS occurrence is an unexpected or unplanned event on DOE property which causes bodily harm, death, damage to government property, exposure to toxic or hazardous substances above acceptable limits to workers, the environment, or general public. Examples of potential reportable occurrences include, but not limited to, site personnel exposures to airborne contaminants, incidents which could expose the general public to high levels of radiation or other contaminants, a vehicle accident resulting in property damage or personnel injuries. Listed TAC manager/staff contacts, with the assistance of TAC ORPS Program Coordinators, will determine if the occurrence is reportable under Department of Energy (DOE) Order M 232.1-2. The reportable occurrences will be classified as emergency, unusual, or off-normal. If determined to be reportable, listed TAC manager/staff will verbally report the details of the occurrence to the DOE Duty Officer within 2 hours of initial notification, and provide a written report of the event by noon the following work day

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.

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.

Feasibility study on the acquisition of licensee event data

International Nuclear Information System (INIS)

Kato, W.Y.; Hall, R.E.; Teichmann, T.; Taylor, J.; Luckas, W.J. Jr.; Saha, P.; Samanta, P.; Fragola, J.

1983-01-01

Objective of the study was to assess the feasibility of modifying the LER reporting system as proposed by NRC-AEOD, and/or developing an alternative plan that would in addition collect information about significant events amenable to statistical analysis, such as multi-case, multi-variate analysis. The study indicated that the LERs constitute reports from a large variety of events which have in most cases many different plant parameters, both measured and currently not measured, to characterize the event. In order to determine event-specific plant parameters required for statistical and deterministic analysis, a data matrix approach was used to identify those parameters which are currently being recorded, those which could be measured and recorded, and those which are required for certain types of events involving thermal-hydraulics and neutronics as illustrative of events requiring in-depth analysis. Also included in the study was a review of INPO's Nuclear Plant Reliability Data System; NASA's Problem Reporting and Corrective Action (PRACA) program; Electricite de France's KIT system, an automatic computer-based reactor parameter monitoring and recording system; and the regulatory relationship between the FAA and the commercial airline industry

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 ...

Nuclear Power Plant Operating Experience from the IAEA/NEA International Reporting System for Operating Experience 2012-2014

International Nuclear Information System (INIS)

2018-03-01

The International Reporting System for Operating Experience (IRS) is an essential element of the international operating experience feedback system for nuclear power plants. Its fundamental objective is to contribute to improving safety of commercial nuclear power plants which are operated worldwide. IRS reports contain information on events of safety significance with important lessons learned which assist in reducing recurrence of events at other plants. This sixth publication, covering the period 2012 - 2014, follows the structure of the previous editions. It highlights important lessons based on a review of the approximately 240 event reports received from the participating countries over this period.

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).

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.

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

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

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...

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

Collecting operational event data for statistical analysis

International Nuclear Information System (INIS)

Atwood, C.L.

1994-09-01

This report gives guidance for collecting operational data to be used for statistical analysis, especially analysis of event counts. It discusses how to define the purpose of the study, the unit (system, component, etc.) to be studied, events to be counted, and demand or exposure time. Examples are given of classification systems for events in the data sources. A checklist summarizes the essential steps in data collection for statistical analysis

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...

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

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

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.

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.

Blood Pressure Elevation Associated with Topical Prostaglandin F2α Analogs: An Analysis of the Different Spontaneous Adverse Event Report Databases.

Science.gov (United States)

Ohyama, Katsuhiro; Kawakami, Haruna; Inoue, Michiko

2017-01-01

Topical prostaglandin F2α (PGF2α) analogs are widely used as the first line of therapy for glaucoma. Systemic PGF2α is suggested to increase blood pressure. Some ophthalmic formulations with β-receptor blocking or α-receptor stimulating actions are reported to cause systemic adverse events such as a decrease in heart rate and blood pressure. The objective of this study was to evaluate the association between topical PGF2α analogs and blood pressure elevation. We analyzed the reports obtained from the Food and Drug Administration Adverse Event Reporting System (FAERS) database from the first quarter of 2004 until the end of 2015 and the Japanese Adverse Drug Event Report (JADER) database from April 2004 to January 2016 for signal detection using reporting odds ratio (ROR), a method of disproportionality analyses. Signals are considered significant if the ROR estimates and lower bound of the 95% confidence interval (CI) exceed 1. Preferred terms in the Medical Dictionary for Regulatory Activities were utilized to define blood pressure elevation. A total of 6156081 reports from the FAERS and 351226 reports from the JADER were analyzed. The significant RORs with 95% CI were calculated to be 1.82 (95% CI: 1.55-2.13) for bimatoprost, 1.69 (95% CI: 1.53-1.85) for latanoprost, and 2.17 (95% CI: 1.82-2.59) for travoprost from the FAERS. From the JADER, 5.01 (95% CI: 1.59-15.8) was calculated for bimatoprost and 8.02 (95% CI: 2.94-21.9) for tafluprost. The resulting data suggest the necessity for further clinical research on blood pressure elevation associated with topical PGF2α analogs and close monitoring.

Design and implementation of a near-miss reporting system at a large, academic pediatric anesthesia department.

Science.gov (United States)

Guffey, Patrick; Szolnoki, Judit; Caldwell, James; Polaner, David

2011-07-01

Current incident reporting systems encourage retrospective reporting of morbidity and mortality and have low participation rates. A near miss is an event that did not cause patient harm, but had the potential to. By tracking and analyzing near misses, systems improvements can be targeted appropriately, and future errors may be prevented. An electronic, web based, secure, anonymous reporting system for anesthesiologists was designed and instituted at The Children's Hospital, Denver. This portal was compared to an existing hospital incident reporting system. A total of 150 incidents were reported in the first 3 months of operation, compared to four entered in the same time period 1 year ago. An anesthesia-specific anonymous near-miss reporting system, which eases and facilitates data entry and can prospectively identify processes and practices that place patients at risk, was implemented at a large, academic, freestanding children's hospital. This resulted in a dramatic increase in reported events and provided data to target and drive quality and process improvement. © 2011 Blackwell Publishing Ltd.

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.

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

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.

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...

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

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

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

A System for the Feedback of Experience from Events in Nuclear Installations. Safety Guide (Spanish Edition); Un sistema de retroinformacion sobre la experiencia derivada de sucesos ocurridos en establecimientos nucleares. Guia de seguridad

Energy Technology Data Exchange (ETDEWEB)

NONE

2012-07-15

This Safety Guide provides recommendations on all the main components of operating experience feedback systems, utilizing relevant information on events and abnormal conditions that have occurred at nuclear installations around the world. It focuses on the interaction between the different systems for using operating experience feedback and constitutes an update and an extension of Part I, A National System, of Systems for Reporting Unusual Events in Nuclear Power Plants (IAEA Safety Series No. 93). Contents: 1. Introduction; 2. Main elements of a national system for the feedback of operational experience; 3. Screening of events; 4. Investigation and analysis of events; 5. Corrective actions; 6. Trending and review to recognize emergent problems; 7. Utilization, dissemination and exchange of information on operating experience; 8. Reviewing the effectiveness of the process for feedback of operational experience; 9. Quality assurance; 10. Reporting of safety related events; Appendix I: Reporting criteria and categories; Appendix II: Types of event report, timing, format and content; Appendix III: Investigation and analysis of events; Appendix IV: Approval and implementation of corrective actions; Annex I: Data management for the feedback of operating experience; Annex II: Example of elements of a national feedback system for operating experience.

Event-Triggered Output-Feedback Control for Disturbed Linear Systems

Directory of Open Access Journals (Sweden)

Hao Jiang

2018-01-01

Full Text Available In the last few decades, event-triggered control received considerable attention, because of advantages in reducing the resource utilization, such as communication load and processor. In this paper, we propose an event-triggered output-feedback controller for disturbed linear systems, in order to achieve both better resource utilization and disturbance attenuation properties at the same time. Based on our prior work on state-feedback H∞ control for disturbed systems, we propose an approach to design an output-feedback H∞ controller for the system whose states are not completely observable, and a sufficient condition guaranteeing the asymptotic stability and robustness of the system is given in the form of LMIs (Linear Matrix Inequalities.

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

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.

Application of the international nuclear events scale in Mexico

International Nuclear Information System (INIS)

Ramirez, R.

1997-01-01

Currently in Mexico, there are two nuclear power reactors and one research reactor operating. Any event related have to be reported to the regulatory body which is in charge of the evaluation and classification using the IAEA INES system. This system has been used since its creation, process in which personnel from the regulatory body was involved. This paper describes the reporting, evaluation and classification process by which events go through with the use of the INES system

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)

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

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

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...

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)

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)

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.

Properties of incident reporting systems in relation to statistical trend and pattern analysis

International Nuclear Information System (INIS)

Kalfsbeek, H.W.; Arsenis, S.P.

1990-01-01

This paper describes the properties deemed desirable for an incident reporting system in order to render it useful for extracting valid statistical trend and pattern information. The perspective under which a data collection system is seen in this paper is the following: data are essentially gathered on a set of variables describing an event or incident (the items featuring on a reporting format) in order to learn about (multiple) dependencies (called interactions) between these variables. Hence, the necessary features of the data source are highlighted and potential problem sources limiting the validity of the results to be obtained are identified. In this frame, important issues are the reporting completeness, related to the reporting criteria and reporting frequency, and of course the reporting contents and quality. The choice of the report items (the variables) and their categorization (code dictionary) may influence (bias) the insights gained from trend and pattern analyses, as may the presence or absence of a structure for correlating the reported issues within an incident. The issues addressed in this paper are brought in relation to some real world reporting systems on safety related events in Nuclear Power Plants, so that their possibilities and limitations with regard to statistical trend and pattern analysis become manifest

An Event-Based Approach to Distributed Diagnosis of Continuous Systems

Science.gov (United States)

Daigle, Matthew; Roychoudhurry, Indranil; Biswas, Gautam; Koutsoukos, Xenofon

2010-01-01

Distributed fault diagnosis solutions are becoming necessary due to the complexity of modern engineering systems, and the advent of smart sensors and computing elements. This paper presents a novel event-based approach for distributed diagnosis of abrupt parametric faults in continuous systems, based on a qualitative abstraction of measurement deviations from the nominal behavior. We systematically derive dynamic fault signatures expressed as event-based fault models. We develop a distributed diagnoser design algorithm that uses these models for designing local event-based diagnosers based on global diagnosability analysis. The local diagnosers each generate globally correct diagnosis results locally, without a centralized coordinator, and by communicating a minimal number of measurements between themselves. The proposed approach is applied to a multi-tank system, and results demonstrate a marked improvement in scalability compared to a centralized approach.

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)

Performance of the CMS Event Builder

CERN Document Server

Andre, Jean-Marc Olivier; Branson, James; Brummer, Philipp Maximilian; Chaze, Olivier; Cittolin, Sergio; Contescu, Cristian; Craigs, Benjamin Gordon; Darlea, Georgiana Lavinia; Deldicque, Christian; Demiragli, Zeynep; Dobson, Marc; Doualot, Nicolas; Erhan, Samim; Fulcher, Jonathan Richard; Gigi, Dominique; Gladki, Maciej Szymon; Glege, Frank; Gomez Ceballos, Guillelmo; Hegeman, Jeroen Guido; Holzner, Andre Georg; Janulis, Mindaugas; Jimenez Estupinan, Raul; Masetti, Lorenzo; Meijers, Franciscus; Meschi, Emilio; Mommsen, Remigius; Morovic, Srecko; O'Dell, Vivian; Orsini, Luciano; Paus, Christoph Maria Ernst; Petrova, Petia; Pieri, Marco; Racz, Attila; Reis, Thomas; Sakulin, Hannes; Schwick, Christoph; Simelevicius, Dainius; Zejdl, Petr

2017-01-01

The data acquisition system (DAQ) of the CMS experiment at the CERN Large Hadron Collider (LHC) assembles events at a rate of 100 kHz. It transports event data at an aggregate throughput of ~100 GB/s to the high-level trigger (HLT) farm. The CMS DAQ system has been completely rebuilt during the first long shutdown of the LHC in 2013/14. The new DAQ architecture is based on state-of-the-art network technologies for the event building. For the data concentration, 10/40 Gb/s Ethernet technologies are used together with a reduced TCP/IP protocol implemented in FPGA for a reliable transport between custom electronics and commercial computing hardware. A 56 Gb/s Infiniband FDR CLOS network has been chosen for the event builder. We report on the performance of the event builder system and the steps taken to exploit the full potential of the network technologies.

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.

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

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.

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.

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

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.

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

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...

Vaccine Adverse Events

Science.gov (United States)

... for Biologics Evaluation & Research Vaccine Adverse Events Vaccine Adverse Events Share Tweet Linkedin Pin it More sharing ... in the primary immunization series in infants Report Adverse Event Report a Vaccine Adverse Event Contact FDA ( ...

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.

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.

Power System Event Ranking Using a New Linear Parameter-Varying Modeling with a Wide Area Measurement System-Based Approach

Directory of Open Access Journals (Sweden)

Mohammad Bagher Abolhasani Jabali

2017-07-01

Full Text Available Detecting critical power system events for Dynamic Security Assessment (DSA is required for reliability improvement. The approach proposed in this paper investigates the effects of events on dynamic behavior during nonlinear system response while common approaches use steady-state conditions after events. This paper presents some new and enhanced indices for event ranking based on time-domain simulation and polytopic linear parameter-varying (LPV modeling of a power system. In the proposed approach, a polytopic LPV representation is generated via linearization about some points of the nonlinear dynamic behavior of power system using wide-area measurement system (WAMS concepts and then event ranking is done based on the frequency response of the system models on the vertices. Therefore, the nonlinear behaviors of the system in the time of fault occurrence are considered for events ranking. The proposed algorithm is applied to a power system using nonlinear simulation. The comparison of the results especially in different fault conditions shows the advantages of the proposed approach and indices.

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.

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.

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