75 FR 16140 - Common Formats for Patient Safety Data Collection and Event Reporting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-31

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Common Formats for Patient Safety Data Collection and Event Reporting AGENCY: Agency for Healthcare Research and... mandatory reporting system, collaborative/voluntary reporting system, research-related reporting system, or...

Avation Safety Reporting System (ASRS) 40th Anniversary

NASA Image and Video Library

2016-09-28

Avation Safety Reporting System (ASRS) 40th Anniversary lunch and open house at the Sunnyvale office. Thomas A Edwards, Deputy Center Director NASA Ames (Left), presents a plaque On the anniversary of the aviation safety reporting system, this award is in recognition of 18 years of outstanding leadership as Program Director, resulting in strong program growth, expanded partnership and a widely recognized impact on National and Global transportation safety. Presented to Linda J. Connell, ASRS Program Director (Right)

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

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

Not Available

1992-03-01

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

A review and discussion of flight management system incidents reported to the Aviation Safety Reporting System

DOT National Transportation Integrated Search

1992-02-01

This report covers the activities related to the description, classification and : analysis of the types and kinds of flight crew errors, incidents and actions, as : reported to the Aviation Safety Reporting System (ASRS) database, that can occur as ...

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

PubMed

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

2017-08-01

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

Urban and suburban arterial safety performance functions : final report.

DOT National Transportation Integrated Search

2016-06-30

This report documents findings from a comprehensive set of safety performance functions developed for the entire urban-suburban : arterial road segment system on the state highway system in Washington. Conventional urban suburban safety performance :...

Targeting errors in the ICU: use of a national database.

PubMed

Kleinpell, Ruth; Thompson, David; Kelso, Lynn; Pronovost, Peter J

2006-12-01

The authors believe that as we move from viewing adverse event reporting system as punitive, and as the safety culture improves, reporting will likely increase. Voluntary incident reporting systems can be used to improve patient safety in the ICU by identifying broken or inadequate systems that lead to adverse events [26]. Voluntary external reporting systems such as the ICUSRS can be used to target errors and produce evidence-based best practice measures to improve patient safety in the ICU.

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

PubMed

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.

NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

1979-01-01

The human factors frequency considered a cause of or contributor to hazardous events onboard air carriers are examined with emphasis on distractions. Safety reports that have been analyzed, processed, and entered into the aviation safety reporting system data base are discussed. A sampling of alert bulletins and responses to them is also presented.

Creating the Web-based Intensive Care Unit Safety Reporting System

PubMed Central

Holzmueller, Christine G.; Pronovost, Peter J.; Dickman, Fern; Thompson, David A.; Wu, Albert W.; Lubomski, Lisa H.; Fahey, Maureen; Steinwachs, Donald M.; Engineer, Lilly; Jaffrey, Ali; Morlock, Laura L.; Dorman, Todd

2005-01-01

In an effort to improve patient safety, researchers at the Johns Hopkins University designed and implemented a comprehensive Web-based Intensive Care Unit Safety Reporting System (ICUSRS). The ICUSRS collects data about adverse events and near misses from all staff in the ICU. This report reflects data on 854 reports from 18 diverse ICUs across the United States. Reporting is voluntary, and data collected is confidential, with patient, provider, and reporter information deidentified. Preliminary data include system factors reported, degree of patient harm, reporting times, and evaluations of the system. Qualitative and quantitative data are reported back to the ICU site study teams and frontline staff through monthly reports, case discussions, and a quarterly newsletter. PMID:15561794

A safety incident reporting system for primary care. A systematic literature review and consensus procedure by the LINNEAUS collaboration on patient safety in primary care

PubMed Central

Klemp, Kerstin; Zwart, Dorien; Hansen, Jørgen; Hellebek, Torben; Luettel, Dagmar; Verstappen, Wim; Beyer, Martin; Gerlach, Ferdin M.; Hoffmann, Barbara; Esmail, Aneez

2015-01-01

Background: Incident reporting is widely used in both patient safety improvement programmes, and in research on patient safety. Objective: To identify the key requirements for incident reporting systems in primary care; to develop an Internet-based incident reporting and learning system for primary care. Methods: A literature review looking at the purpose, design and requirements of an incident reporting system (IRS) was used to update an existing incident reporting system, widely used in Germany. Then, an international expert panel with knowledge on IRS developed the criteria for the design of a new web-based incident reporting system for European primary care. A small demonstration project was used to create a web-based reporting system, to be made freely available for practitioners and researchers. The expert group compiled recommendations regarding the desirable features of an incident reporting system for European primary care. These features covered the purpose of reporting, who should be involved in reporting, the mode of reporting, design considerations, feedback mechanisms and preconditions necessary for the implementation of an IRS. Results: A freely available web-based reporting form was developed, based on these criteria. It can be modified for local contexts. Practitioners and researchers can use this system as a means of recording patient safety incidents in their locality and use it as a basis for learning from errors. Conclusion: The LINNEAUS collaboration has provided a freely available incident reporting system that can be modified for a local context and used throughout Europe. PMID:26339835

On Building an Ontological Knowledge Base for Managing Patient Safety Events.

PubMed

Liang, Chen; Gong, Yang

2015-01-01

Over the past decade, improving healthcare quality and safety through patient safety event reporting systems has drawn much attention. Unfortunately, such systems are suffering from low data quality, inefficient data entry and ineffective information retrieval. For improving the systems, we develop a semantic web ontology based on the WHO International Classification for Patient Safety (ICPS) and AHRQ Common Formats for patient safety event reporting. The ontology holds potential in enhancing knowledge management and information retrieval, as well as providing flexible data entry and case analysis for both reporters and reviewers of patient safety events. In this paper, we detailed our efforts in data acquisition, transformation, implementation and initial evaluation of the ontology.

Nature of Blame in Patient Safety Incident Reports: Mixed Methods Analysis of a National Database.

PubMed

Cooper, Jennifer; Edwards, Adrian; Williams, Huw; Sheikh, Aziz; Parry, Gareth; Hibbert, Peter; Butlin, Amy; Donaldson, Liam; Carson-Stevens, Andrew

2017-09-01

A culture of blame and fear of retribution are recognized barriers to reporting patient safety incidents. The extent of blame attribution in safety incident reports, which may reflect the underlying safety culture of health care systems, is unknown. This study set out to explore the nature of blame in family practice safety incident reports. We characterized a random sample of family practice patient safety incident reports from the England and Wales National Reporting and Learning System. Reports were analyzed according to prespecified classification systems to describe the incident type, contributory factors, outcomes, and severity of harm. We developed a taxonomy of blame attribution, and we then used descriptive statistical analyses to identify the proportions of blame types and to explore associations between incident characteristics and one type of blame. Health care professionals making family practice incident reports attributed blame to a person in 45% of cases (n = 975 of 2,148; 95% CI, 43%-47%). In 36% of cases, those who reported the incidents attributed fault to another person, whereas 2% of those reporting acknowledged personal responsibility. Blame was commonly associated with incidents where a complaint was anticipated. The high frequency of blame in these safety, incident reports may reflect a health care culture that leads to blame and retribution, rather than to identifying areas for learning and improvement, and a failure to appreciate the contribution of system factors in others' behavior. Successful improvement in patient safety through the analysis of incident reports is unlikely without achieving a blame-free culture. © 2017 Annals of Family Medicine, Inc.

Nature of Blame in Patient Safety Incident Reports: Mixed Methods Analysis of a National Database

PubMed Central

Cooper, Jennifer; Edwards, Adrian; Williams, Huw; Sheikh, Aziz; Parry, Gareth; Hibbert, Peter; Butlin, Amy; Donaldson, Liam; Carson-Stevens, Andrew

2017-01-01

PURPOSE A culture of blame and fear of retribution are recognized barriers to reporting patient safety incidents. The extent of blame attribution in safety incident reports, which may reflect the underlying safety culture of health care systems, is unknown. This study set out to explore the nature of blame in family practice safety incident reports. METHODS We characterized a random sample of family practice patient safety incident reports from the England and Wales National Reporting and Learning System. Reports were analyzed according to prespecified classification systems to describe the incident type, contributory factors, outcomes, and severity of harm. We developed a taxonomy of blame attribution, and we then used descriptive statistical analyses to identify the proportions of blame types and to explore associations between incident characteristics and one type of blame. RESULTS Health care professionals making family practice incident reports attributed blame to a person in 45% of cases (n = 975 of 2,148; 95% CI, 43%–47%). In 36% of cases, those who reported the incidents attributed fault to another person, whereas 2% of those reporting acknowledged personal responsibility. Blame was commonly associated with incidents where a complaint was anticipated. CONCLUSIONS The high frequency of blame in these safety, incident reports may reflect a health care culture that leads to blame and retribution, rather than to identifying areas for learning and improvement, and a failure to appreciate the contribution of system factors in others’ behavior. Successful improvement in patient safety through the analysis of incident reports is unlikely without achieving a blame-free culture. PMID:28893816

Overview of Risk Mitigation for Safety-Critical Computer-Based Systems

NASA Technical Reports Server (NTRS)

Torres-Pomales, Wilfredo

2015-01-01

This report presents a high-level overview of a general strategy to mitigate the risks from threats to safety-critical computer-based systems. In this context, a safety threat is a process or phenomenon that can cause operational safety hazards in the form of computational system failures. This report is intended to provide insight into the safety-risk mitigation problem and the characteristics of potential solutions. The limitations of the general risk mitigation strategy are discussed and some options to overcome these limitations are provided. This work is part of an ongoing effort to enable well-founded assurance of safety-related properties of complex safety-critical computer-based aircraft systems by developing an effective capability to model and reason about the safety implications of system requirements and design.

Analysis of Aviation Safety Reporting System Incident Data Associated With the Technical Challenges of the Vehicle Systems Safety Technology Project

NASA Technical Reports Server (NTRS)

Withrow, Colleen A.; Reveley, Mary S.

2014-01-01

This analysis was conducted to support the Vehicle Systems Safety Technology (VSST) Project of the Aviation Safety Program (AVsP) milestone VSST4.2.1.01, "Identification of VSST-Related Trends." In particular, this is a review of incident data from the NASA Aviation Safety Reporting System (ASRS). The following three VSST-related technical challenges (TCs) were the focus of the incidents searched in the ASRS database: (1) Vechicle health assurance, (2) Effective crew-system interactions and decisions in all conditions; and (3) Aircraft loss of control prevention, mitigation, and recovery.

Implementation of a Data-Based Medical Event Reporting System in the U.S. Department of Defense

DTIC Science & Technology

2005-05-01

where patient safety events warrant further investigation. Introduction Department of Defense Instruction 6025.17 established the Military Health ...Administration (VHA) Patient Safety Reporting Program for error tracking and reporting within all military health care facilities. 5 On August 16, 2001...DoD Instruction number 6025.17 “established a Military Health System Patient Safety Center (MHSPSC), including a MHS Patient Safety Registry (MHSPSR

Safety Management Information Statistics (SAMIS) - 1991 Annual Report

DOT National Transportation Integrated Search

1993-02-01

The Safety Management Information Statistics 1991 Annual Report is a compilation and analysis of mass transit accident and casualty statistics reported by transit systems in the United States during 1991, under FTA's Section 15 reporting system.

Increasing Patient Safety Event Reporting in an Emergency Medicine Residency.

PubMed

Steen, Sven; Jaeger, Cassie; Price, Lindsay; Griffen, David

2017-01-01

Patient safety event reporting is an important component for fostering a culture of safety. Our tertiary care hospital utilizes a computerized patient safety event reporting system that has been historically underutilized by residents and faculty, despite encouragement of its use. The objective of this quality project was to increase patient safety event reporting within our Emergency Medicine residency program. Knowledge of event reporting was evaluated with a survey. Eighteen residents and five faculty participated in a formal educational session on event reporting followed by feedback every two months on events reported and actions taken. The educational session included description of which events to report and the logistics of accessing the reporting system. Participants received a survey after the educational intervention to assess resident familiarity and comfort with using the system. The total number of events reported was obtained before and after the educational session. After the educational session, residents reported being more confident in knowing what to report as a patient safety event, knowing how to report events, how to access the reporting tool, and how to enter a patient safety event. In the 14 months preceding the educational session, an average of 0.4 events were reported per month from the residency. In the nine months following the educational session, an average of 3.7 events were reported per month by the residency. In addition, the reported events resulted in meaningful actions taken by the hospital to improve patient safety, which were shared with the residents. Improvement efforts including an educational session, feedback to the residency of events reported, and communication of improvements resulting from reported events successfully increased the frequency of safety event reporting in an Emergency Medicine residency.

An examination of safety reports involving electronic flight bags and portable electronic devices

DOT National Transportation Integrated Search

2014-06-01

The purpose of this research was to develop a better understanding of safety considerations with the use of Electronic Flight Bags (EFBs) and Portable Electronic Devices (PEDs) by examining safety reports from Aviation Safety Reporting System (ASRS),...

77 FR 58616 - Pipeline Safety: Information Collection Activities, Revision to Gas Transmission and Gathering...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-21

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2012-0024] Pipeline Safety: Information Collection Activities, Revision to Gas Transmission and Gathering Pipeline Systems Annual Report, Gas Transmission and Gathering Pipeline Systems Incident Report...

Medical students' perceptions of a novel institutional incident reporting system : A thematic analysis.

PubMed

Gordon, Morris; Parakh, Dillan

2017-10-01

Errors in healthcare are a major patient safety issue, with incident reporting a key solution. The incident reporting system has been integrated within a new medical curriculum, encouraging medical students to take part in this key safety process. The aim of this study was to describe the system and assess how students perceived the reporting system with regards to its role in enhancing safety. Employing a thematic analysis, this study used interviews with medical students at the end of the first year. Thematic indices were developed according to the information emerging from the data. Through open, axial and then selective stages of coding, an understanding of how the system was perceived was established. Analysis of the interview specified five core themes: (1) Aims of the incident reporting system; (2) internalized cognition of the system; (3) the impact of the reporting system; (4) threshold for reporting; (5) feedback on the systems operation. Selective analysis revealed three overriding findings: lack of error awareness and error wisdom as underpinned by key theoretical constructs, student support of the principle of safety, and perceptions of a blame culture. Students did not interpret reporting as a manner to support institutional learning and safety, rather many perceived it as a tool for a blame culture. The impact reporting had on students was unexpected and may give insight into how other undergraduates and early graduates interpret such a system. Future studies should aim to produce interventions that can support a reporting culture.

Evaluation Of The Vehicle Radar Safety Systems Rashid Radar Safety Brake Collision Warning System, Final Report

DOT National Transportation Integrated Search

1988-02-01

THIS EVALUATION OF THE VEHICLE RADAR SAFETY SYSTEMS? ANTI-COLLISION DEVICE (HEREAFTER VRSS) WAS UNDERTAKEN BY THE OPERATOR PERFORMANCE AND SAFETY ANALYSIS DIVISION OF THE TRANSPORTATION SYSTEMS CENTER AT THE REQUEST OF THE NATIONAL HIGHWAY TRAFFIC SA...

EMS helicopter incidents reported to the NASA Aviation Safety Reporting System

NASA Technical Reports Server (NTRS)

Connell, Linda J.; Reynard, William D.

1993-01-01

The objectives of this evaluation were to: Identify the types of safety-related incidents reported to the Aviation Safety Reporting System (ASRS) in Emergency Medical Service (EMS) helicopter operations; Describe the operational conditions surrounding these incidents, such as weather, airspace, flight phase, time of day; and Assess the contribution to these incidents of selected human factors considerations, such as communication, distraction, time pressure, workload, and flight/duty impact.

Learning from Taiwan patient-safety reporting system.

PubMed

Lin, Chung-Chih; Shih, Chung-Liang; Liao, Hsun-Hsiang; Wung, Cathy H Y

2012-12-01

The aim of this study is to create a national database to record incidents that endanger patient safety. We try to identify systemic problems in hospitals in order to avoid safety incidents in the future and improve the quality of healthcare. The Taiwan Patient Safety Reporting System employs a voluntary notification model. We define 13 types of patient safety incidents, and the reports of different types of incidents are recorded using common terminology. Statistical analysis is used to identify the incident type, time of occurrence, location, person who reported the incident, and possible reasons for frequently occurring incidents. There were 340 hospitals that joined this program from 2005 to 2010. Over 128,271 incident events were reported and analyzed. The three most common incidents were drug-related incidents, falls, and endo tube related incidents. By analyzing the time of occurrence of incidents, we found that drug-related incidents usually occurred between 8 and 10 am. Falls and endo tube incidents usually occurred between 4 and 6 am. The most common location was wards (57.6%), followed by intensive care areas (13.5%), and pharmacies (9.1%). Among hospital staff, nurses reported the highest number of incidents (68.9%), followed by pharmacists (14.5%) and administrative staff (5.5%). The number of incidents reported by doctors was much lower (1.2%). Most staff members who reported incidents had been working for less than five years (58.1%). The unified reporting system was found to improve the recording and analysis of patient safety incidents. To encourage hospital staff to report incidents, hospitals need to be assisted in establishing an internal report and management system for safety incidents. Hospitals also need a protection mechanism to allow staff members to report incidents without the fear of punishment. By identifying the root causes of safety incidents and sharing the lessons learned across hospitals is the only way such incidents can be stopped from happening again. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Human factors in airport surface incidents : an analysis of pilot reports submitted to the Aviation Safety Reporting System (ASRS)

DOT National Transportation Integrated Search

2006-12-01

The purpose of this study was to examine human factors involved in airport surface incidents as reported by pilots. Reports submitted to the : Aviation Safety Reporting System (ASRS) are a good source of information regarding the human performance is...

NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

Billings, C. E.; Lauber, J. K.; Funkhouser, H.; Lyman, E. G.; Huff, E. M.

1976-01-01

The origins and development of the NASA Aviation Safety Reporting System (ASRS) are briefly reviewed. The results of the first quarter's activity are summarized and discussed. Examples are given of bulletins describing potential air safety hazards, and the disposition of these bulletins. During the first quarter of operation, the ASRS received 1464 reports; 1407 provided data relevant to air safety. All reports are being processed for entry into the ASRS data base. During the reporting period, 130 alert bulletins describing possible problems in the aviation system were generated and disseminated. Responses were received from FAA and others regarding 108 of the alert bulletins. Action was being taken with respect to 70 of the 108 responses received. Further studies are planned of a number of areas, including human factors problems related to automation of the ground and airborne portions of the national aviation system.

33 CFR 96.250 - What documents and reports must a safety management system have?

Code of Federal Regulations, 2010 CFR

2010-07-01

...) Safety management system document and data maintenance (1) Procedures which establish and maintain control of all documents and data relevant to the safety management system. (2) Documents are available at... safety management system have? 96.250 Section 96.250 Navigation and Navigable Waters COAST GUARD...

NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

1977-01-01

During the third quarter of operation of the Aviation Safety Reporting System (ASRS), 1429 reports concerning aviation safety were received from pilots, air traffic controllers, and others in the national aviation system. Details of the administration and results of the program are discussed. The design and construction of the ASRS data base are briefly presented. Altitude deviations and potential aircraft conflicts associated with misunderstood clearances were studied and the results are discussed. Summary data regarding alert bulletins, examples of alert bulletins and responses to them, and a sample of deidentified ASRS reports are provided.

Overview of Energy Systems' safety analysis report programs

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

Not Available

1992-03-01

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

Flight deck party line issues : an Aviation Safety Reporting System analysis

DOT National Transportation Integrated Search

1995-06-01

This document describes an analysis of the Aviation Safety Reporting System : (ASRS) database with regards to human factors aspects concerning the : implementation of Data Link into the flightdeck. The ASRS database contains : thousands of reports co...

Integrated care: an Information Model for Patient Safety and Vigilance Reporting Systems.

PubMed

Rodrigues, Jean-Marie; Schulz, Stefan; Souvignet, Julien

2015-01-01

Quality management information systems for safety as a whole or for specific vigilances share the same information types but are not interoperable. An international initiative tries to develop an integrated information model for patient safety and vigilance reporting to support a global approach of heath care quality.

A Synthetic Vision Preliminary Integrated Safety Analysis

NASA Technical Reports Server (NTRS)

Hemm, Robert; Houser, Scott

2001-01-01

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

WE-G-BRA-03: Developing a Culture of Patient Safety Utilizing the National Radiation Oncology Incident Learning System (ROILS)

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

Hasson, B; Workie, D; Geraghty, C

Purpose: To transition from an in-house incident reporting system to a ROILS standards system with the intent to develop a safety focused culture in the Department and enroll in ROILS. Methods: Since the AAPM Safety Summit (2010) several safety and reporting systems have been implemented within the Department. Specific checklists and SBAR reporting systems were introduced. However, the active learning component was lost due to reporting being viewed with distrust and possible retribution.To Facilitate introducing ROILS each leader in the Department received a copy of the ROILS participation guide. Four specific tasks were assigned to each leader: develop a reportingmore » tree, begin the ROILS based system, facilitate adopting ROILS Terminology, and educate the staff on expectations of safety culture. Next, the ROILS questions were broken down into area specific questions (10–15) per departmental area. Excel spreadsheets were developed for each area and setup for error reporting entries. The Role of the Process Improvement Committee (PI) has been modified to review and make recommendations based on the ROILS entries. Results: The ROILS based Reporting has been in place for 4 months. To date 64 reports have been entered. Since the adoption of ROILS the reporting of incidents has increased from 2/month to 18/month on average. Three reports had a dosimetric effect on the patient (<5%) dose variance. The large majority of entries have been Characterized as Processes not followed or not sure how to Characterize, and Human Behavior. Conclusion: The majority of errors are typo’s that create confusion. The introduction of the ROILS standards has provided a platform for making changes to policies that increase patient safety. The goal is to develop a culture that sees reporting at a national level as a safe and effective way to improve our safety, and to dynamically learn from other institutions reporting.« less

NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

1976-01-01

During the second quarter of the Aviation Safety Reporting System (ASRS) operation, 1,497 reports were received from pilots, controllers, and others in the national aviation system. Details of the administration and results of the program to date are presented. Examples of alert bulletins disseminated to the aviation community are presented together with responses to those bulletins. Several reports received by ASRS are also presented to illustrate the diversity of topics covered by reports to the system.

Feedback from incident reporting: information and action to improve patient safety.

PubMed

Benn, J; Koutantji, M; Wallace, L; Spurgeon, P; Rejman, M; Healey, A; Vincent, C

2009-02-01

Effective feedback from incident reporting systems in healthcare is essential if organisations are to learn from failures in the delivery of care. Despite the wide-scale development and implementation of incident reporting in healthcare, studies in the UK suggest that information concerning system vulnerabilities could be better applied to improve operational safety within organisations. In this article, the findings and implications of research to identify forms of effective feedback from incident reporting are discussed, to promote best practices in this area. The research comprised a mixed methods review to investigate mechanisms of effective feedback for healthcare, drawing upon experience within established reporting programmes in high-risk industry and transport domains. Systematic searches of published literature were undertaken, and 23 case studies describing incident reporting programmes with feedback were identified for analysis from the international healthcare literature. Semistructured interviews were undertaken with 19 subject matter experts across a range of domains, including: civil aviation, maritime, energy, rail, offshore production and healthcare. In analysis, qualitative information from several sources was synthesised into practical requirements for developing effective feedback in healthcare. Both action and information feedback mechanisms were identified, serving safety awareness, improvement and motivational functions. The provision of actionable feedback that visibly improved systems was highlighted as important in promoting future reporting. Fifteen requirements for the design of effective feedback systems were identified, concerning: the role of leadership, the credibility and content of information, effective dissemination channels, the capacity for rapid action and the need for feedback at all levels of the organisation, among others. Above all, the safety-feedback cycle must be closed by ensuring that reporting, analysis and investigation result in timely corrective actions that effectively address vulnerabilities in existing work systems. Limited research evidence exists concerning the issue of effective forms of safety feedback within healthcare. Much valuable operational knowledge resides in safety management communities within high-risk industries. Multiple means of feeding back recommended actions and safety information may be usefully employed to promote safety awareness, improve clinical processes and promote future reporting. Further work is needed to establish best practices for feedback systems in healthcare that effectively close the safety loop.

Patient Safety Incident Reporting: Current Trends and Gaps Within the Canadian Health System.

PubMed

Boucaud, Sarah; Dorschner, Danielle

2016-01-01

Patient safety incidents are a national-level phenomenon, requiring a pan-Canadian approach to ensure that incidents are reported and lessons are learned and broadly disseminated. This work explores the variation in current provincial and local approaches to reporting through a literature review. Trends are consolidated and recommendations are offered to foster better alignment of existing systems. These include adopting a common terminology, defining the patient role in reporting, increasing system users' perception of safety and further investigating the areas of home and community care in ensuring standard approaches at the local level. These steps can promote alignment, reducing barriers to a future pan-Canadian reporting and learning system.

76 FR 12300 - Safety Management System for Certificated Airports; Extension of Comment Period

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-07

...-0997; Notice No. 10-14] RIN 2120-AJ38 Safety Management System for Certificated Airports; Extension of...: Background On October 7, 2010, the FAA published Notice No. 10-14, entitled ``Safety Management System for... conclusions from the safety management systems proof of concept. The FAA anticipates making this report...

Using a quantitative risk register to promote learning from a patient safety reporting system.

PubMed

Mansfield, James G; Caplan, Robert A; Campos, John S; Dreis, David F; Furman, Cathie

2015-02-01

Patient safety reporting systems are now used in most health care delivery organizations. These systems, such as the one in use at Virginia Mason (Seattle) since 2002, can provide valuable reports of risk and harm from the front lines of patient care. In response to the challenge of how to quantify and prioritize safety opportunities, a risk register system was developed and implemented. Basic risk register concepts were refined to provide a systematic way to understand risks reported by staff. The risk register uses a comprehensive taxonomy of patient risk and algorithmically assigns each patient safety report to 1 of 27 risk categories in three major domains (Evaluation, Treatment, and Critical Interactions). For each category, a composite score was calculated on the basis of event rate, harm, and cost. The composite scores were used to identify the "top five" risk categories, and patient safety reports in these categories were analyzed in greater depth to find recurrent patterns of risk and associated opportunities for improvement. The top five categories of risk were easy to identify and had distinctive "profiles" of rate, harm, and cost. The ability to categorize and rank risks across multiple dimensions yielded insights not previously available. These results were shared with leadership and served as input for planning quality and safety initiatives. This approach provided actionable input for the strategic planning process, while at the same time strengthening the Virginia Mason culture of safety. The quantitative patient safety risk register serves as one solution to the challenge of extracting valuable safety lessons from large numbers of incident reports and could profitably be adopted by other organizations.

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

DOT National Transportation Integrated Search

2010-12-01

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

Early Warning: Development of Confidential Incident Reporting Systems

NASA Technical Reports Server (NTRS)

OLeary, Mike J.; Chappell, Sheryl L.; Connell, Linda (Technical Monitor)

1996-01-01

Accidents hardly ever happen without warning. The combination, or sequence, of failures and mistakes that cause an accident may indeed be unique but the individual failures and mistakes rarely are. In the USA in 1974 the crews on two different aircraft misunderstood the same aeronautical chart and descended towards their destination dangerously early towards a mountain. The first crew were in good weather conditions and could see the mountain and resolved their misinterpretation of the chart. The second crew six weeks later were not so lucky. In cloud they had no clues to point out their mistake nor the presence of the mountain. The resulting crash and the ensuing inquiry, which brought to light the previous incident, shocked the country but gave it the impetus to instigate a safety reporting system. This system eventually became the NASA's Aviation Safety Reporting System (ASRS). The programme collects incident reports from pilots, controllers, mechanics, cabin attendants and many others involved in aviation operations. By disseminating this safety information the ASRS has helped enormously to give US airlines and airspace the highest safety standards. Accident prevention is a goal sought by everyone in the aviation industry and establishing effective incident reporting programmes can go a long way toward achieving that goal. This article will describe the steps and issues required to establish an incident reporting system. The authors summarize the lessons learned from the ASRS, now in its twentieth year of operation and from the Confidential Human Factors Reporting (HER) Programme run by British Airways, an airline that is a recognized world leader in safety reporting and analysis. The differences between government and airline operation of confidential safety reporting systems will be addressed.

78 FR 71036 - Pipeline Safety: Random Drug Testing Rate; Contractor Management Information System Reporting...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-27

... PHMSA-2013-0248] Pipeline Safety: Random Drug Testing Rate; Contractor Management Information System Reporting; and Obtaining Drug and Alcohol Management Information System Sign-In Information AGENCY: Pipeline... Management Information System (MIS) Data; and New Method for Operators to Obtain User Name and Password for...

Pilot-controller communication errors : an analysis of Aviation Safety Reporting System (ASRS) reports

DOT National Transportation Integrated Search

1998-08-01

The purpose of this study was to identify the factors that contribute to pilot-controller communication errors. Resports submitted to the Aviation Safety Reporting System (ASRS) offer detailed accounts of specific types of errors and a great deal of ...

78 FR 14877 - Pipeline Safety: Incident and Accident Reports

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-07

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket ID PHMSA-2013-0028] Pipeline Safety: Incident and Accident Reports AGENCY: Pipeline and Hazardous Materials... PHMSA F 7100.2--Incident Report--Natural and Other Gas Transmission and Gathering Pipeline Systems and...

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

PubMed

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.

Developing and Testing the Health Care Safety Hotline

PubMed Central

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.

2017-01-01

Abstract 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. PMID:28845353

RPP-PRT-58489, Revision 1, One Systems Consistent Safety Analysis Methodologies Report. 24590-WTP-RPT-MGT-15-014

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

Gupta, Mukesh; Niemi, Belinda; Paik, Ingle

2015-09-02

In 2012, One System Nuclear Safety performed a comparison of the safety bases for the Tank Farms Operations Contractor (TOC) and Hanford Tank Waste Treatment and Immobilization Plant (WTP) (RPP-RPT-53222 / 24590-WTP-RPT-MGT-12-018, “One System Report of Comparative Evaluation of Safety Bases for Hanford Waste Treatment and Immobilization Plant Project and Tank Operations Contract”), and identified 25 recommendations that required further evaluation for consensus disposition. This report documents ten NSSC approved consistent methodologies and guides and the results of the additional evaluation process using a new set of evaluation criteria developed for the evaluation of the new methodologies.

Health Care Worker Fatigue.

PubMed

Gardner, Lea Anne; Dubeck, Deborah

2016-08-01

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

Sharing adverse drug event data using business intelligence technology.

PubMed

Horvath, Monica M; Cozart, Heidi; Ahmad, Asif; Langman, Matthew K; Ferranti, Jeffrey

2009-03-01

Duke University Health System uses computerized adverse drug event surveillance as an integral part of medication safety at 2 community hospitals and an academic medical center. This information must be swiftly communicated to organizational patient safety stakeholders to find opportunities to improve patient care; however, this process is encumbered by highly manual methods of preparing the data. Following the examples of other industries, we deployed a business intelligence tool to provide dynamic safety reports on adverse drug events. Once data were migrated into the health system data warehouse, we developed census-adjusted reports with user-driven prompts. Drill down functionality enables navigation from aggregate trends to event details by clicking report graphics. Reports can be accessed by patient safety leadership either through an existing safety reporting portal or the health system performance improvement Web site. Elaborate prompt screens allow many varieties of reports to be created quickly by patient safety personnel without consultation with the research analyst. The reduction in research analyst workload because of business intelligence implementation made this individual available to additional patient safety projects thereby leveraging their talents more effectively. Dedicated liaisons are essential to ensure clear communication between clinical and technical staff throughout the development life cycle. Design and development of the business intelligence model for adverse drug event data must reflect the eccentricities of the operational system, especially as new areas of emphasis evolve. Future usability studies examining the data presentation and access model are needed.

Development of Incident Report Database for Organizational Learning

NASA Astrophysics Data System (ADS)

Otsuka, Yuichi; Abe, Tomotaka; Noguchi, Hiroshi; Makinouchi, Akifumi

The necessity of an incident reporting system has recently been increasing for hospitals. Japan Council for Quality Health Care (JCQHC) started operating a national incident reporting system to which domestic hospitals would report their incidents. However, the reporting system obtained an additional problem for the hospitals. They managed their own systems which collected reports by papers. The purposes of the reporting systems was to analyze considerable causes involved in incidents to improve the quality of patient safety management. On the contrary, the national reporting system aimed at collecting a statistical tendency of normal incidents. Simultaneously operating the two systems would be too much workload for safety managers. The load may have the managers rest only a short time for summarizing occurrences, not enough for analyzing their causes. However, to the authors' knowledge, there has not been an integrating policy of the two forms to adapt them to practical situations in patient safety management. The scope of this paper is to establish the integrated form in order to use in analyzing the causes of incidents as well as reporting for the national system. We have developed new data base system using XML + XSLT and Java Servlet. The developed system is composed of three computers; DB server , DB client and Data sending server. To investigate usability of the developed system, we conducted a monitoring test by real workers in reporting workplaces. The result of subjective evaluations by examinees was so preferable for the developed system. The results of usability test and the achievement of increasing the number of reports after the introduction can demonstrate the enough effectiveness of the developed system for supporting the activity of patient safety management.

Laboratory evaluation of alcohol safety interlock systems. Volume 1 : summary report

DOT National Transportation Integrated Search

1974-01-01

The report contains the results of an experimental and analytical evaluation of instruments and techniques designed to prevent an intoxicated driver from operating his automobile. The prototype 'Alcohol Safety Interlock Systems' tested were developed...

Identification of Crew-Systems Interactions and Decision Related Trends

NASA Technical Reports Server (NTRS)

Jones, Sharon Monica; Evans, Joni K.; Reveley, Mary S.; Withrow, Colleen A.; Ancel, Ersin; Barr, Lawrence

2013-01-01

NASA Vehicle System Safety Technology (VSST) project management uses systems analysis to identify key issues and maintain a portfolio of research leading to potential solutions to its three identified technical challenges. Statistical data and published safety priority lists from academic, industry and other government agencies were reviewed and analyzed by NASA Aviation Safety Program (AvSP) systems analysis personnel to identify issues and future research needs related to one of VSST's technical challenges, Crew Decision Making (CDM). The data examined in the study were obtained from the National Transportation Safety Board (NTSB) Aviation Accident and Incident Data System, Federal Aviation Administration (FAA) Accident/Incident Data System and the NASA Aviation Safety Reporting System (ASRS). In addition, this report contains the results of a review of safety priority lists, information databases and other documented references pertaining to aviation crew systems issues and future research needs. The specific sources examined were: Commercial Aviation Safety Team (CAST) Safety Enhancements Reserved for Future Implementation (SERFIs), Flight Deck Automation Issues (FDAI) and NTSB Most Wanted List and Open Recommendations. Various automation issues taxonomies and priority lists pertaining to human factors, automation and flight design were combined to create a list of automation issues related to CDM.

Electronic clinical safety reporting system: a benefits evaluation.

PubMed

Elliott, Pamela; Martin, Desmond; Neville, Doreen

2014-06-11

Eastern Health, a large health care organization in Newfoundland and Labrador (NL), started a staged implementation of an electronic occurrence reporting system (used interchangeably with "clinical safety reporting system") in 2008, completing Phase One in 2009. The electronic clinical safety reporting system (CSRS) was designed to replace a paper-based system. The CSRS involves reporting on occurrences such as falls, safety/security issues, medication errors, treatment and procedural mishaps, medical equipment malfunctions, and close calls. The electronic system was purchased from a vendor in the United Kingdom that had implemented the system in the United Kingdom and other places, such as British Columbia. The main objective of the new system was to improve the reporting process with the goal of improving clinical safety. The project was funded jointly by Eastern Health and Canada Health Infoway. The objectives of the evaluation were to: (1) assess the CSRS on achieving its stated objectives (particularly, the benefits realized and lessons learned), and (2) identify contributions, if any, that can be made to the emerging field of electronic clinical safety reporting. The evaluation involved mixed methods, including extensive stakeholder participation, pre/post comparative study design, and triangulation of data where possible. The data were collected from several sources, such as project documentation, occurrence reporting records, stakeholder workshops, surveys, focus groups, and key informant interviews. The findings provided evidence that frontline staff and managers support the CSRS, identifying both benefits and areas for improvement. Many benefits were realized, such as increases in the number of occurrences reported, in occurrences reported within 48 hours, in occurrences reported by staff other than registered nurses, in close calls reported, and improved timelines for notification. There was also user satisfaction with the tool regarding ease of use, accessibility, and consistency. The implementation process encountered challenges related to customizing the software and the development of the classification system for coding occurrences. This impacted on the ability of the managers to close-out files in a timely fashion. The issues that were identified, and suggestions for improvements to the form itself, were shared with the Project Team as soon as they were noted. Changes were made to the system before the rollout. There were many benefits realized from the new system that can contribute to improved clinical safety. The participants preferred the electronic system over the paper-based system. The lessons learned during the implementation process resulted in recommendations that informed the rollout of the system in Eastern Health, and in other health care organizations in the province of Newfoundland and Labrador. This study also informed the evaluation of other health organizations in the province, which was completed in 2013.

Comprehensive Lifecycle for Assuring System Safety

NASA Technical Reports Server (NTRS)

Knight, John C.; Rowanhill, Jonathan C.

2017-01-01

CLASS is a novel approach to the enhancement of system safety in which the system safety case becomes the focus of safety engineering throughout the system lifecycle. CLASS also expands the role of the safety case across all phases of the system's lifetime, from concept formation to decommissioning. As CLASS has been developed, the concept has been generalized to a more comprehensive notion of assurance becoming the driving goal, where safety is an important special case. This report summarizes major aspects of CLASS and contains a bibliography of papers that provide additional details.

Safety Management Information Statistics (SAMIS) - 1995 Annual Report

DOT National Transportation Integrated Search

1997-04-01

The Safety Management Information Statistics 1995 Annual Report is a compilation and analysis of transit accident, casualty and crime statistics reported under the Federal Transit Administration's National Transit Database Reporting by transit system...

Improving patient safety incident reporting systems by focusing upon feedback - lessons from English and Welsh trusts.

PubMed

Wallace, Louise M; Spurgeon, Peter; Benn, Jonathan; Koutantji, Maria; Vincent, Charles

2009-08-01

This paper describes practical implications and learning from a multi-method study of feedback from patient safety incident reporting systems. The study was performed using the Safety Action and Information Feedback from Incident Reporting model, a model of the requirements of the feedback element of a patient safety incident reporting and learning system, derived from a scoping review of research and expert advice from world leaders in safety in high-risk industries. We present the key findings of the studies conducted in the National Health Services (NHS) trusts in England and Wales in 2006. These were a survey completed by risk managers for 351 trusts in England and Wales, three case studies including interviews with staff concerning an example of good practice feedback and an audit of 90 trusts clinical risk staff newsletters. We draw on an Expert Workshop that included 71 experts from the NHS, from regulatory bodies in health care, Royal Colleges, Health and Safety Executive and safety agencies in health care and high-risk industries (commercial aviation, rail and maritime industries). We draw recommendations of enduring relevance to the UK NHS that can be used by trust staff to improve their systems. The recommendations will be of relevance in general terms to health services worldwide.

Quality and Safety Education for Nurses (QSEN): The Key is Systems Thinking.

PubMed

Dolansky, Mary A; Moore, Shirley M

2013-09-30

Over a decade has passed since the Institute of Medicine's reports on the need to improve the American healthcare system, and yet only slight improvement in quality and safety has been reported. The Quality and Safety Education for Nurses (QSEN) initiative was developed to integrate quality and safety competencies into nursing education. The current challenge is for nurses to move beyond the application of QSEN competencies to individual patients and families and incorporate systems thinking in quality and safety education and healthcare delivery. This article provides a history of QSEN and proposes a framework in which systems thinking is a critical aspect in the application of the QSEN competencies. We provide examples of how using this framework expands nursing focus from individual care to care of the system and propose ways to teach and measure systems thinking. The conclusion calls for movement from personal effort and individual care to a focus on care of the system that will accelerate improvement of healthcare quality and safety.

The Application of Software Safety to the Constellation Program Launch Control System

NASA Technical Reports Server (NTRS)

Kania, James; Hill, Janice

2011-01-01

The application of software safety practices on the LCS project resulted in the successful implementation of the NASA Software Safety Standard NASA-STD-8719.138 and CxP software safety requirements. The GOP-GEN-GSW-011 Hazard Report was the first report developed at KSC to identify software hazard causes and their controls. This approach can be applied to similar large software - intensive systems where loss of control can lead to a hazard.

Patient Safety Reporting Systems: Sustained Quality Improvement Using a Multidisciplinary Team and “Good Catch” Awards

PubMed Central

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

2014-01-01

Background Since 1999, hospitals have made substantial commitments to healthcare quality and patient safety through individual initiatives of executive leadership involvement in quality, investments in safety culture, education and training for medical students and residents in quality and safety, the creation of patient safety committees, and implementation of patient safety reporting systems. Cohesive quality and safety approaches have become comprehensive programs to identify and mitigate hazards that could harm patients. This article moves to the next level with an intense refocusing of attention on one of the individual components of a comprehensive program--the patient safety reporting system—with a goal of maximized usefulness of the reports and long-term sustainability of quality improvements arising from them. Methods A six-phase framework was developed to deal with patient safety hazards: identify, report, analyze, mitigate, reward, and follow up. Unique features of this process included a multidisciplinary team to review reports, mitigate hazards, educate and empower providers, recognize the identifying/reporting individuals or groups with “Good Catch” awards, and follow up to determine if quality improvements were sustained over time. Results To date, 29 patient safety hazards have gone through this process with “Good Catch” awards being granted at our institution. These awards were presented at various times over the past 4 years since the process began in 2008. Follow-up revealed that 86% of the associated quality improvements have been sustained over time since the awards were given. We present the details of two of these “Good Catch” awards: vials of heparin with an unusually high concentration of the drug that posed a potential overdose hazard and a rapid infusion device that resisted practitioner control. Conclusion A multidisciplinary team's analysis and mitigation of hazards identified in a patient safety reporting system, positive recognition with a “Good Catch” award, education of practitioners, and long-term follow-up resulted in an outcome of sustained quality improvement initiatives. PMID:22946251

Avation Safety Reporting System (ASRS) 40th Anniversary.

NASA Image and Video Library

2016-09-28

Avation Safety Reporting System (ASRS) 40th Anniversary lunch and open house at the Sunnyvale office. Linda J. Connell, ASRS Program Director (left); Dr. John Lauber, Resident Scientist and early pioneer of the ASRS at Ames, 1972-1985 (Right).

Safety of High Speed Ground Transportation Systems : Analytical Methodology for Safety Validation of Computer Controlled Subsystems : Volume 2. Development of a Safety Validation Methodology

DOT National Transportation Integrated Search

1995-01-01

This report describes the development of a methodology designed to assure that a sufficiently high level of safety is achieved and maintained in computer-based systems which perform safety cortical functions in high-speed rail or magnetic levitation ...

From Board to Bedside: How the Application of Financial Structures to Safety and Quality Can Drive Accountability in a Large Health Care System.

PubMed

Austin, J Matthew; Demski, Renee; Callender, Tiffany; Lee, K H Ken; Hoffman, Ann; Allen, Lisa; Radke, Deborah A; Kim, Yungjin; Werthman, Ronald J; Peterson, Ronald R; Pronovost, Peter J

2017-04-01

As the health care system in the United States places greater emphasis on the public reporting of quality and safety data and its use to determine payment, provider organizations must implement structures that ensure discipline and rigor regarding these data. An academic health system, as part of a performance management system, applied four key components of a financial reporting structure to support the goal of top-to-bottom accountability for improving quality and safety. The four components implemented by Johns Hopkins Medicine were governance, accountability, reporting of consolidated quality performance statements, and auditing. Governance is provided by the health system's Patient Safety and Quality Board Committee, which reviews goals and strategy for patient safety and quality, reviews quarterly performance for each entity, and holds organizational leaders accountable for performance. An accountability plan includes escalating levels of review corresponding to the number of months an entity misses the defined performance target for a measure. A consolidated quality statement helps inform the Patient Safety and Quality Board Committee and leadership on key quality and safety issues. An audit evaluates the efficiency and effectiveness of processes for data collection, validation, and storage, as to ensure the accuracy and completeness of quality measure reporting. If hospitals and health systems truly want to prioritize improvements in safety and quality, they will need to create a performance management system that ensures data validity and supports performance accountability. Without valid data, it is difficult to know whether a performance gap is due to data quality or clinical quality. Copyright © 2017 The Joint Commission. Published by Elsevier Inc. All rights reserved.

Motorcoach and school bus fire safety analysis.

DOT National Transportation Integrated Search

2016-11-01

This report documents a motorcoach and school bus fire safety analysis performed by the John A. Volpe National Transportation Systems Center (Volpe) for the Federal Motor Carrier Safety Administration. This report aims to: 1) identify the causes, fre...

78 FR 71033 - Pipeline Safety: Information Collection Activities, Revisions to Incident and Annual Reports for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-27

... Reports for Gas Pipeline Operators AGENCY: Pipeline and Hazardous Materials Safety Administration, DOT... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No... Pipeline Systems; PHMSA F 7100.2-1 Annual Report for Calendar Year 20xx Natural and Other Gas Transmission...

Another Approach to Enhance Airline Safety: Using Management Safety Tools

NASA Technical Reports Server (NTRS)

Lu, Chien-tsug; Wetmore, Michael; Przetak, Robert

2006-01-01

The ultimate goal of conducting an accident investigation is to prevent similar accidents from happening again and to make operations safer system-wide. Based on the findings extracted from the investigation, the "lesson learned" becomes a genuine part of the safety database making risk management available to safety analysts. The airline industry is no exception. In the US, the FAA has advocated the usage of the System Safety concept in enhancing safety since 2000. Yet, in today s usage of System Safety, the airline industry mainly focuses on risk management, which is a reactive process of the System Safety discipline. In order to extend the merit of System Safety and to prevent accidents beforehand, a specific System Safety tool needs to be applied; so a model of hazard prediction can be formed. To do so, the authors initiated this study by reviewing 189 final accident reports from the National Transportation Safety Board (NTSB) covering FAR Part 121 scheduled operations. The discovered accident causes (direct hazards) were categorized into 10 groups Flight Operations, Ground Crew, Turbulence, Maintenance, Foreign Object Damage (FOD), Flight Attendant, Air Traffic Control, Manufacturer, Passenger, and Federal Aviation Administration. These direct hazards were associated with 36 root factors prepared for an error-elimination model using Fault Tree Analysis (FTA), a leading tool for System Safety experts. An FTA block-diagram model was created, followed by a probability simulation of accidents. Five case studies and reports were provided in order to fully demonstrate the usefulness of System Safety tools in promoting airline safety.

Requirements Analysis for the Army Safety Management Information System (ASMIS)

DTIC Science & Technology

1989-03-01

8217_>’ Telephone Number « .. PNL-6819 Limited Distribution Requirements Analysis for the Army Safety Management Information System (ASMIS) Final...PNL-6819 REQUIREMENTS ANALYSIS FOR THE ARMY SAFETY MANAGEMENT INFORMATION SYSTEM (ASMIS) FINAL REPORT J. S. Littlefield A. L. Corrigan March...accidents. This accident data is available under the Army Safety Management Information System (ASMIS) which is an umbrella for many databases

Why System Safety Professionals Should Read Accident Reports

NASA Technical Reports Server (NTRS)

Holloway, C. M.; Johnson, C. W.

2006-01-01

System safety professionals, both researchers and practitioners, who regularly read accident reports reap important benefits. These benefits include an improved ability to separate myths from reality, including both myths about specific accidents and ones concerning accidents in general; an increased understanding of the consequences of unlikely events, which can help inform future designs; a greater recognition of the limits of mathematical models; and guidance on potentially relevant research directions that may contribute to safety improvements in future systems.

Integrated vehicle-based safety systems (IVBSS) : heavy truck extended pilot test summary report.

DOT National Transportation Integrated Search

2009-05-01

This report describes the findings and recommendations from the heavy-truck (HT) extended pilot test (EPT) conducted by University of Michigan Transportation Research Institute (UMTRI) and its partners under the Integrated Vehicle-Based Safety System...

Measurable improvement in patient safety culture: A departmental experience with incident learning.

PubMed

Kusano, Aaron S; Nyflot, Matthew J; Zeng, Jing; Sponseller, Patricia A; Ermoian, Ralph; Jordan, Loucille; Carlson, Joshua; Novak, Avrey; Kane, Gabrielle; Ford, Eric C

2015-01-01

Rigorous use of departmental incident learning is integral to improving patient safety and quality of care. The goal of this study was to quantify the impact of a high-volume, departmental incident learning system on patient safety culture. A prospective, voluntary, electronic incident learning system was implemented in February 2012 with the intent of tracking near-miss/no-harm incidents. All incident reports were reviewed weekly by a multiprofessional team with regular department-wide feedback. Patient safety culture was measured at baseline with validated patient safety culture survey questions. A repeat survey was conducted after 1 and 2 years of departmental incident learning. Proportional changes were compared by χ(2) or Fisher exact test, where appropriate. Between 2012 and 2014, a total of 1897 error/near-miss incidents were reported, representing an average of 1 near-miss report per patient treated. Reports were filed by a cross section of staff, with the majority of incidents reported by therapists, dosimetrists, and physicists. Survey response rates at baseline and 1 and 2 years were 78%, 80%, and 80%, respectively. Statistically significant and sustained improvements were noted in several safety metrics, including belief that the department was openly discussing ways to improve safety, the sense that reports were being used for safety improvement, and the sense that changes were being evaluated for effectiveness. None of the surveyed dimensions of patient safety culture worsened. Fewer punitive concerns were noted, with statistically significant decreases in the worry of embarrassment in front of colleagues and fear of getting colleagues in trouble. A comprehensive incident learning system can identify many areas for improvement and is associated with significant and sustained improvements in patient safety culture. These data provide valuable guidance as incident learning systems become more widely used in radiation oncology. Copyright © 2015 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

Caring for class III obese patients.

PubMed

Gardner, Lea Anne

2013-11-01

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

Safety Management Information Statistics (SAMIS) - 1994 Annual Report

DOT National Transportation Integrated Search

1996-07-01

The Safety Management Information Statistics 1994 Annual Report is a compilation and analysis of mass transit accident and casualty statistics reported by transit systems in the United States during 1994, reported under the Federal Transit Administra...

Assessment of Safety Standards for Automotive Electronic Control Systems

DOT National Transportation Integrated Search

2016-06-01

This report summarizes the results of a study that assessed and compared six industry and government safety standards relevant to the safety and reliability of automotive electronic control systems. These standards include ISO 26262 (Road Vehicles - ...

The NASA Aviation Safety Reporting System

NASA Technical Reports Server (NTRS)

1983-01-01

This is the fourteenth in a series of reports based on safety-related incidents submitted to the NASA Aviation Safety Reporting System by pilots, controllers, and, occasionally, other participants in the National Aviation System (refs. 1-13). ASRS operates under a memorandum of agreement between the National Aviation and Space Administration and the Federal Aviation Administration. The report contains, first, a special study prepared by the ASRS Office Staff, of pilot- and controller-submitted reports related to the perceived operation of the ATC system since the 1981 walkout of the controllers' labor organization. Next is a research paper analyzing incidents occurring while single-pilot crews were conducting IFR flights. A third section presents a selection of Alert Bulletins issued by ASRS, with the responses they have elicited from FAA and others concerned. Finally, the report contains a list of publications produced by ASRS with instructions for obtaining them.

Review of safety reports involving electronic flight bags

DOT National Transportation Integrated Search

2009-04-27

Electronic Flight Bags (EFBs) are a relatively new device used by pilots. Even so, 37 safety-related events involving EFBs were identified from the public online Aviation Safety Reporting System (ASRS) database as of June 2008. In addition, two accid...

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

PubMed

Vogus, Timothy J; Sutcliffe, Kathleen M

2011-01-01

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

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

PubMed

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

2014-09-01

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

Patient-reported experiences of patient safety incidents need to be utilized more systematically in promoting safe care.

PubMed

Sahlström, Merja; Partanen, Pirjo; Turunen, Hannele

2018-04-16

To analyze patient safety incidents (PSIs) reported by patients and their use in Finnish healthcare organizations. Cross-sectional study. About 15 Finnish healthcare organizations ranging from specialized hospital care to home care, outpatient and inpatient clinics, and geographically diverse areas of Finland. The study population included all Finnish patients who had voluntarily reported PSI via web-based system in 2009-15. Quantitative analysis of patients' safety reports, inductive content analysis of patients' suggestions to prevent the reoccurrence incidents and how those suggestions were used in healthcare organizations. Patients reported 656 PSIs, most of which were classified by the healthcare organizations' analysts as problems associated with information flow (32.6%) and medications (18%). Most of the incidents (65%) did not cause any harm to patients. About 76% of the reports suggested ways to prevent reoccurrence of PSIs, most of which were feasible, system-based amendments of processes for reviewing or administering treatment, anticipating risks or improving diligence in patient care. However, only 6% had led to practical implementation of corrective actions in the healthcare organizations. The results indicate that patients report diverse PSIs and suggest practical systems-based solutions to prevent their reoccurrence. However, patients' reports rarely lead to corrective actions documented in the registering system, indicating that there is substantial scope to improve utilization of patients' reports. There is also a need for strong patient safety management, including willingness and commitment of HCPs and leaders to learn from safety incidents.

A web-based incident reporting system and multidisciplinary collaborative projects for patient safety in a Japanese hospital

PubMed Central

Nakajima, K; Kurata, Y; Takeda, H

2005-01-01



Problem: When patient safety programs were mandated for Japanese health care institutions, a safety culture, a tool for collecting incident reports, an organizational arrangement for multidisciplinary collaboration, and interventional methods for improvement had to be established. Design: Observational study of effects of new patient safety programs. Setting: Osaka University Hospital, a large government-run teaching hospital. Strategy for change: A voluntary and anonymous web-based incident reporting system was introduced. For the new organizational structure a clinical risk management committee, a department of clinical quality management, and area clinical risk managers were established with their respective roles clearly defined to advance the plan-do-study-act cycle and to integrate efforts. For preventive action, alert procedures, staff education, ward rounds by peers, a system oriented approach for reducing errors, and various feedback channels were introduced. Effects of change: Continuous incident reporting by all hospital staff has been observed since the introduction of the new system. Several error inducing situations have been improved: wrong choice of drug in computer prescribing, maladministration of drugs due to a look-alike appearance or confusion about the manipulation of a medical device, and poor after hours service of the blood transfusion unit. Staff participation in educational seminars has been dramatically improved. Ward rounds have detected problematic procedures which needed to be dealt with. Lessons learnt: Patient safety programs based on a web-based incident reporting system, responsible persons, staff education, and a variety of feedback procedures can help promote a safety culture, multidisciplinary collaboration, and strong managerial leadership resulting in system oriented improvement. PMID:15805458

NASA Range Safety Annual Report 2007

NASA Technical Reports Server (NTRS)

Dumont, Alan G.

2007-01-01

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

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

DOT National Transportation Integrated Search

1993-09-01

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

Visual warning system for worker safety on roadside work-zones.

DOT National Transportation Integrated Search

2016-08-01

Growing traffic on US roadways and heavy construction machinery on road construction sites pose a critical safety : threat to construction workers. This report summarizes the design and development of a worker safety system using : Dedicated Short Ra...

Antecedents of willingness to report medical treatment errors in health care organizations: a multilevel theoretical framework.

PubMed

Naveh, Eitan; Katz-Navon, Tal

2014-01-01

To avoid errors and improve patient safety and quality of care, health care organizations need to identify the sources of failures and facilitate implementation of corrective actions. Hence, health care organizations try to collect reports and data about errors by investing enormous resources in reporting systems. However, despite health care organizations' declared goal of increasing the voluntary reporting of errors and although the Patient Safety and Quality Improvement Act of 2005 (S.544, Public Law 109-41) legalizes efforts to secure reporters from specific liabilities, the problem of underreporting of adverse events by staff members remains. The purpose of the paper is to develop a theory-based model and a set of propositions to understand the antecedents of staff members' willingness to report errors based on a literature synthesis. The model aims to explore a complex system of considerations employees use when deciding whether to report their errors or be silent about them. The model integrates the influences of three types of organizational climates (psychological safety, psychological contracts, and safety climate) and individual perceptions of the applicability of the organization's procedures and proposes their mutual influence on willingness to report errors and, as a consequence, patient safety. The model suggests that managers should try to control and influence both the way employees perceive procedure applicability and organizational context-i.e., psychological safety, no-blame contracts, and safety climate-to increase reporting and improve patient safety.

Safety analysis report for packaging (onsite) steel drum

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

McCormick, W.A.

This Safety Analysis Report for Packaging (SARP) provides the analyses and evaluations necessary to demonstrate that the steel drum packaging system meets the transportation safety requirements of HNF-PRO-154, Responsibilities and Procedures for all Hazardous Material Shipments, for an onsite packaging containing Type B quantities of solid and liquid radioactive materials. The basic component of the steel drum packaging system is the 208 L (55-gal) steel drum.

Federal Motor Carrier Safety Administration’s Advanced System Testing Utilizing a Data Acquisition System on the Highways (FAST DASH) Safety Technology Evaluation Project #2: Driver Monitoring Final Report.

DOT National Transportation Integrated Search

2016-12-01

An independent evaluation of a non-video-based onboard monitoring system (OBMS) was conducted. The objective was to determine if the OBMS system performed reliably, improved driving safety and performance, and improved fuel efficiency in a commercial...

Federal Motor Carrier Safety Administration’s advanced system testing utilizing a data acquisition system on the highways (FAST DASH) safety technology evaluation project #2 : driver monitoring, final report.

DOT National Transportation Integrated Search

2016-11-01

An independent evaluation of a non-video-based onboard monitoring system (OBMS) was conducted. The objective was to determine if the OBMS system performed reliably, improved driving safety and performance, and improved fuel efficiency in a commercial...

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

Decision support methods for the detection of adverse events in post-marketing data.

PubMed

Hauben, M; Bate, A

2009-04-01

Spontaneous reporting is a crucial component of post-marketing drug safety surveillance despite its significant limitations. The size and complexity of some spontaneous reporting system databases represent a challenge for drug safety professionals who traditionally have relied heavily on the scientific and clinical acumen of the prepared mind. Computer algorithms that calculate statistical measures of reporting frequency for huge numbers of drug-event combinations are increasingly used to support pharamcovigilance analysts screening large spontaneous reporting system databases. After an overview of pharmacovigilance and spontaneous reporting systems, we discuss the theory and application of contemporary computer algorithms in regular use, those under development, and the practical considerations involved in the implementation of computer algorithms within a comprehensive and holistic drug safety signal detection program.

Avation Safety Reporting System (ASRS) 40th Anniversary.

NASA Image and Video Library

2016-09-28

Avation Safety Reporting System (ASRS) 40th Anniversary lunch and open house at the Sunnyvale office. Linda J. Connell, ASRS Program Director (Left); Thomas A Edwards, Deputy Center Director NASA Ames; Dr. John Lauber, Resident Scientist and pioneer of the ASRS at Ames from 1972-1985 (Right).

49 CFR 191.12 - Distribution Systems: Mechanical Fitting Failure Reports

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Distribution Systems: Mechanical Fitting Failure Reports 191.12 Section 191.12 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER...

49 CFR 191.11 - Distribution system: Annual report.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Distribution system: Annual report. 191.11 Section 191.11 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE;...

49 CFR 191.9 - Distribution system: Incident report.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Distribution system: Incident report. 191.9 Section 191.9 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE;...

Obtaining Valid Safety Data for Software Safety Measurement and Process Improvement

NASA Technical Reports Server (NTRS)

Basili, Victor r.; Zelkowitz, Marvin V.; Layman, Lucas; Dangle, Kathleen; Diep, Madeline

2010-01-01

We report on a preliminary case study to examine software safety risk in the early design phase of the NASA Constellation spaceflight program. Our goal is to provide NASA quality assurance managers with information regarding the ongoing state of software safety across the program. We examined 154 hazard reports created during the preliminary design phase of three major flight hardware systems within the Constellation program. Our purpose was two-fold: 1) to quantify the relative importance of software with respect to system safety; and 2) to identify potential risks due to incorrect application of the safety process, deficiencies in the safety process, or the lack of a defined process. One early outcome of this work was to show that there are structural deficiencies in collecting valid safety data that make software safety different from hardware safety. In our conclusions we present some of these deficiencies.

Safety analysis and review system (SARS) assessment report

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

Browne, E.T.

1981-03-01

Under DOE Order 5481.1, Safety Analysis and Review System for DOE Operations, safety analyses are required for DOE projects in order to ensure that: (1) potential hazards are systematically identified; (2) potential impacts are analyzed; (3) reasonable measures have been taken to eliminate, control, or mitigate the hazards; and (4) there is documented management authorization of the DOE operation based on an objective assessment of the adequacy of the safety analysis. This report is intended to provide the DOE Office of Plans and Technology Assessment (OPTA) with an independent evaluation of the adequacy of the ongoing safety analysis effort. Asmore » part of this effort, a number of site visits and interviews were conducted, and FE SARS documents were reviewed. The latter included SARS Implementation Plans for a number of FE field offices, as well as safety analysis reports completed for certain FE operations. This report summarizes SARS related efforts at the DOE field offices visited and evaluates the extent to which they fulfill the requirements of DOE 5481.1.« less

A New Cure for Medical Errors

NASA Technical Reports Server (NTRS)

2002-01-01

In May 2000, senior officials of the U.S. Department of Veterans Affairs (VA) and NASA signed an agreement that would commit the two agencies to create the Patient Safety Reporting System (PSRS) to report: events or situations that could have resulted in accident, injury, or illness, but did not, either by chance or through timely intervention (close-calls); unexpected serious occurrences that involved a patient or employee's death, physical injury, or psychological injury; lessens learned; and safety ideas. The VA provided NASA with funding for the initial development of the new system, which automatically removes all personal names, facility names and locations, and other potentially identifying information before entering reports into its database. Designed to complement the VA's current internal reporting systems, the PSRS is modeled after NASA's Aviation Safety Reporting System, which was established in 1975 under a Memorandum of Agreement between the Federal Aviation Administration and NASA and began operation in 1976.

A Method for Evaluating the Safety Impacts of Air Traffic Automation

NASA Technical Reports Server (NTRS)

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

1998-01-01

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

Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS)

PubMed Central

Shimabukuro, Tom T.; Nguyen, Michael; Martin, David; DeStefano, Frank

2015-01-01

The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) conduct post-licensure vaccine safety monitoring using the Vaccine Adverse Event Reporting System (VAERS), a spontaneous (or passive) reporting system. This means that after a vaccine is approved, CDC and FDA continue to monitor safety while it is distributed in the marketplace for use by collecting and analyzing spontaneous reports of adverse events that occur in persons following vaccination. Various methods and statistical techniques are used to analyze VAERS data, which CDC and FDA use to guide further safety evaluations and inform decisions around vaccine recommendations and regulatory action. VAERS data must be interpreted with caution due to the inherent limitations of passive surveillance. VAERS is primarily a safety signal detection and hypothesis generating system. Generally, VAERS data cannot be used to determine if a vaccine caused an adverse event. VAERS data interpreted alone or out of context can lead to erroneous conclusions about cause and effect as well as the risk of adverse events occurring following vaccination. CDC makes VAERS data available to the public and readily accessible online. We describe fundamental vaccine safety concepts, provide an overview of VAERS for healthcare professionals who provide vaccinations and might want to report or better understand a vaccine adverse event, and explain how CDC and FDA analyze VAERS data. We also describe strengths and limitations, and address common misconceptions about VAERS. Information in this review will be helpful for healthcare professionals counseling patients, parents, and others on vaccine safety and benefit-risk balance of vaccination. PMID:26209838

Ground Operations and ASRS

NASA Technical Reports Server (NTRS)

Connell, Linda; Wichner, David; Jakey, Abegail Marie

2013-01-01

The Aviation Safety Reporting System (ASRS) in a partnership between the National Aeronautics and Space Administration (NASA), the Federal Aviation Administration (FAA), participating carriers, and labor organizations. It is designed to improve the National Airspace System by collecting and studying reports detailing unsafe conditions and events in the aviation industry. Employees are able to report safety issues or concerns with confidentiality and without fear of discipline

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

PubMed

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

2012-08-01

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

78 FR 70398 - Proposed Agency Information Collection Activities; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-25

... System Evaluation-Related Interview Data Collection. OMB Control Number: 2130-0574. Type of Request... approaches to improving safety, FRA has instituted the Confidential Close Call Reporting System (C\\3\\RS). The... reporting component, and a problem analysis/solution component. C\\3\\RS is expected to affect safety in two...

Effect of an anonymous reporting system on near-miss and harmful medical error reporting in a pediatric intensive care unit.

PubMed

Grant, Mary Jo C; Larsen, Gitte Y

2007-01-01

Adverse event reporting is a key element for improving patient safety. This study describes a new voluntary, anonymous reporting system that facilitates reporting of near-miss and patient harm events and an assessment of patient harm by the bedside care provider in a pediatric intensive care unit. The results demonstrated the effectiveness of the Patient Safety Report as a method to capture near-miss and patient harm events.

Screening Electronic Health Record-Related Patient Safety Reports Using Machine Learning.

PubMed

Marella, William M; Sparnon, Erin; Finley, Edward

2017-03-01

The objective of this study was to develop a semiautomated approach to screening cases that describe hazards associated with the electronic health record (EHR) from a mandatory, population-based patient safety reporting system. Potentially relevant cases were identified through a query of the Pennsylvania Patient Safety Reporting System. A random sample of cases were manually screened for relevance and divided into training, testing, and validation data sets to develop a machine learning model. This model was used to automate screening of remaining potentially relevant cases. Of the 4 algorithms tested, a naive Bayes kernel performed best, with an area under the receiver operating characteristic curve of 0.927 ± 0.023, accuracy of 0.855 ± 0.033, and F score of 0.877 ± 0.027. The machine learning model and text mining approach described here are useful tools for identifying and analyzing adverse event and near-miss reports. Although reporting systems are beginning to incorporate structured fields on health information technology and the EHR, these methods can identify related events that reporters classify in other ways. These methods can facilitate analysis of legacy safety reports by retrieving health information technology-related and EHR-related events from databases without fields and controlled values focused on this subject and distinguishing them from reports in which the EHR is mentioned only in passing. Machine learning and text mining are useful additions to the patient safety toolkit and can be used to semiautomate screening and analysis of unstructured text in safety reports from frontline staff.

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

PubMed

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.

Analysis of general aviation single-pilot IFR incident data obtained from the NASA Aviation Safety Reporting System

NASA Technical Reports Server (NTRS)

Bergeron, H. P.

1983-01-01

An analysis of incident data obtained from the NASA Aviation Safety Reporting System (ASRS) has been made to determine the problem areas in general aviation single-pilot IFR (SPIFR) operations. The Aviation Safety Reporting System data base is a compilation of voluntary reports of incidents from any person who has observed or been involved in an occurrence which was believed to have posed a threat to flight safety. This paper examines only those reported incidents specifically related to general aviation single-pilot IFR operations. The frequency of occurrence of factors related to the incidents was the criterion used to define significant problem areas and, hence, to suggest where research is needed. The data was cataloged into one of five major problem areas: (1) controller judgment and response problems, (2) pilot judgment and response problems, (3) air traffic control (ATC) intrafacility and interfacility conflicts, (4) ATC and pilot communication problems, and (5) IFR-VFR conflicts. In addition, several points common to all or most of the problems were observed and reported. These included human error, communications, procedures and rules, and work load.

Defining and classifying medical error: lessons for patient safety reporting systems.

PubMed

Tamuz, M; Thomas, E J; Franchois, K E

2004-02-01

It is important for healthcare providers to report safety related events, but little attention has been paid to how the definition and classification of events affects a hospital's ability to learn from its experience. To examine how the definition and classification of safety related events influences key organizational routines for gathering information, allocating incentives, and analyzing event reporting data. In semi-structured interviews, professional staff and administrators in a tertiary care teaching hospital and its pharmacy were asked to describe the existing programs designed to monitor medication safety, including the reporting systems. With a focus primarily on the pharmacy staff, interviews were audio recorded, transcribed, and analyzed using qualitative research methods. Eighty six interviews were conducted, including 36 in the hospital pharmacy. Examples are presented which show that: (1) the definition of an event could lead to under-reporting; (2) the classification of a medication error into alternative categories can influence the perceived incentives and disincentives for incident reporting; (3) event classification can enhance or impede organizational routines for data analysis and learning; and (4) routines that promote organizational learning within the pharmacy can reduce the flow of medication error data to the hospital. These findings from one hospital raise important practical and research questions about how reporting systems are influenced by the definition and classification of safety related events. By understanding more clearly how hospitals define and classify their experience, we may improve our capacity to learn and ultimately improve patient safety.

Incident reporting: Its role in aviation safety and the acquisition of human error data

NASA Technical Reports Server (NTRS)

Reynard, W. D.

1983-01-01

The rationale for aviation incident reporting systems is presented and contrasted to some of the shortcomings of accident investigation procedures. The history of the United State's Aviation Safety Reporting System (ASRS) is outlined and the program's character explained. The planning elements that resulted in the ASRS program's voluntary, confidential, and non-punitive design are discussed. Immunity, from enforcement action and misuse of the volunteered data, is explained and evaluated. Report generation techniques and the ASRS data analysis process are described; in addition, examples of the ASRS program's output and accomplishments are detailed. Finally, the value of incident reporting for the acquisition of safety information, particularly human error data, is explored.

Critical incident reporting and learning.

PubMed

Mahajan, R P

2010-07-01

The success of incident reporting in improving safety, although obvious in aviation and other high-risk industries, is yet to be seen in health-care systems. An incident reporting system which would improve patient safety would allow front-end clinicians to have easy access for reporting an incident with an understanding that their report will be handled in a non-punitive manner, and that it will lead to enhanced learning regarding the causation of the incident and systemic changes which will prevent it from recurring. At present, significant problems remain with local and national incident reporting systems. These include fear of punitive action, poor safety culture in an organization, lack of understanding among clinicians about what should be reported, lack of awareness of how the reported incidents will be analysed, and how will the reports ultimately lead to changes which will improve patient safety. In particular, lack of systematic analysis of the reports and feedback directly to the clinicians are seen as major barriers to clinical engagement. In this review, robust systematic methodology of analysing incidents is discussed. This methodology is based on human factors model, and the learning paradigm which emphasizes significant shift from traditional judicial approach to understanding how 'latent errors' may play a role in a chain of events which can set up an 'active error' to occur. Feedback directly to the clinicians is extremely important for keeping them 'in the loop' for their continued engagement, and it should target different levels of analyses. In addition to high-level information on the types of incidents, the feedback should incorporate results of the analyses of active and latent factors. Finally, it should inform what actions, and at what level/stage, have been taken in response to the reported incidents. For this, local and national systems will be required to work in close cooperation, so that the lessons can be learnt and actions taken within an organization, and across organizations. In the UK, a recently introduced speciality-specific incident reporting system for anaesthesia aims to incorporate the elements of successful reporting system, as presented in this review, to achieve enhanced clinical engagement and improved patient safety.

Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project.

PubMed

Perez, Raymond P; Finnigan, Shanda; Patel, Krupa; Whitney, Shanell; Forrest, Annemarie

2016-12-15

Use of electronic clinical trial portals has increased in recent years to assist with sponsor-investigator communication, safety reporting, and clinical trial management. Electronic portals can help reduce time and costs associated with processing paperwork and add security measures; however, there is a lack of information on clinical trial investigative staff's perceived challenges and benefits of using portals. The Clinical Trials Transformation Initiative (CTTI) sought to (1) identify challenges to investigator receipt and management of investigational new drug (IND) safety reports at oncologic investigative sites and coordinating centers and (2) facilitate adoption of best practices for communicating and managing IND safety reports using electronic portals. CTTI, a public-private partnership to improve the conduct of clinical trials, distributed surveys and conducted interviews in an opinion-gathering effort to record investigator and research staff views on electronic portals in the context of the new safety reporting requirements described in the US Food and Drug Administration's final rule (Code of Federal Regulations Title 21 Section 312). The project focused on receipt, management, and review of safety reports as opposed to the reporting of adverse events. The top challenge investigators and staff identified in using individual sponsor portals was remembering several complex individual passwords to access each site. Also, certain tasks are time-consuming (eg, downloading reports) due to slow sites or difficulties associated with particular operating systems or software. To improve user experiences, respondents suggested that portals function independently of browsers and operating systems, have intuitive interfaces with easy navigation, and incorporate additional features that would allow users to filter, search, and batch safety reports. Results indicate that an ideal system for sharing expedited IND safety information is through a central portal used by all sponsors. Until this is feasible, electronic reporting portals should at least have consistent functionality. CTTI has issued recommendations to improve the quality and use of electronic portals. ©Raymond P Perez, Shanda Finnigan, Krupa Patel, Shanell Whitney, Annemarie Forrest. Originally published in JMIR Cancer (http://cancer.jmir.org), 15.12.2016.

Experimental evaluation of second-generation alcohol safety-interlock systems

DOT National Transportation Integrated Search

1978-01-01

Author's absract: This report documents the results of laboratory testing of four "second-generation" alcohol safety-interlock systems. As a group, these systems were found to produce appreciable discrimination between sober and intoxicated subjects.

Safety of High Speed Magnetic Levitation Transportation Systems : German High-Speed Maglev Train Safety Requirements - Potential For Application in the United States

DOT National Transportation Integrated Search

1992-02-01

The safety of various magnetically levitated (maglev) trains underdevelopment for possible : implementation in the United States is ofdirect concern to the Federal Railroad Administration (FRA). : This report is the second in a series of reports addr...

A performance improvement case study in aircraft maintenance and its implications for hazard identification.

PubMed

Ward, Marie; McDonald, Nick; Morrison, Rabea; Gaynor, Des; Nugent, Tony

2010-02-01

Aircraft maintenance is a highly regulated, safety critical, complex and competitive industry. There is a need to develop innovative solutions to address process efficiency without compromising safety and quality. This paper presents the case that in order to improve a highly complex system such as aircraft maintenance, it is necessary to develop a comprehensive and ecologically valid model of the operational system, which represents not just what is meant to happen, but what normally happens. This model then provides the backdrop against which to change or improve the system. A performance report, the Blocker Report, specific to aircraft maintenance and related to the model was developed gathering data on anything that 'blocks' task or check performance. A Blocker Resolution Process was designed to resolve blockers and improve the current check system. Significant results were obtained for the company in the first trial and implications for safety management systems and hazard identification are discussed. Statement of Relevance: Aircraft maintenance is a safety critical, complex, competitive industry with a need to develop innovative solutions to address process and safety efficiency. This research addresses this through the development of a comprehensive and ecologically valid model of the system linked with a performance reporting and resolution system.

Onboard Safety Technology Survey Synthesis - Final Report

DOT National Transportation Integrated Search

2008-01-01

The Federal Motor Carrier Safety Administration (FMCSA) funded this project to collect, merge, and conduct an assessment of onboard safety system surveys and resulting data sets that may benefit commercial vehicle operations safety and future researc...

Combining System Safety and Reliability to Ensure NASA CoNNeCT's Success

NASA Technical Reports Server (NTRS)

Havenhill, Maria; Fernandez, Rene; Zampino, Edward

2012-01-01

Hazard Analysis, Failure Modes and Effects Analysis (FMEA), the Limited-Life Items List (LLIL), and the Single Point Failure (SPF) List were applied by System Safety and Reliability engineers on NASA's Communications, Navigation, and Networking reConfigurable Testbed (CoNNeCT) Project. The integrated approach involving cross reviews of these reports by System Safety, Reliability, and Design engineers resulted in the mitigation of all identified hazards. The outcome was that the system met all the safety requirements it was required to meet.

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

PubMed

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

2016-02-01

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

Proceedings of the IEEE International Workshop on Safety of Systems (1st) held in Monterey, California on 15-16 Mar 2007

DTIC Science & Technology

2007-03-01

Information Operations and Reports, 1215 Jefferson Davis Highway, Suite 1204, Arlington, VA 22202-4302, and to the Office of Management and Budget...participation included the following list of topics: Safety engineering of systems-of-systems; Building a safety culture and management of safety...provide Practitioner competence Realistic expectations on practitioners Risk management , such as how to model security problems vii

Analysis of general aviation single-pilot IFR incident data obtained from the NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

Bergeron, H. P.

1980-01-01

Data obtained from the NASA Aviation Safety Reporting System (ASRS) data base were used to determine problems in general aviation single pilot IFR operations. The data examined consisted of incident reports involving flight safety in the National Aviation System. Only those incidents involving general aviation fixed wing aircraft flying under IFR in instrument meteorological conditions were analyzed. The data were cataloged into one of five major problem areas: (1) controller judgement and response problems; (2) pilot judgement and response problems; (3) air traffic control intrafacility and interfacility conflicts; (4) ATC and pilot communications problems; and (5) IFR-VFR conflicts. The significance of the related problems, and the various underlying elements associated with each are discussed. Previous ASRS reports covering several areas of analysis are reviewed.

Safety status system for operating room devices.

PubMed

Guédon, Annetje C P; Wauben, Linda S G L; Overvelde, Marlies; Blok, Joleen H; van der Elst, Maarten; Dankelman, Jenny; van den Dobbelsteen, John J

2014-01-01

Since the increase of the number of technological aids in the operating room (OR), equipment-related incidents have come to be a common kind of adverse events. This underlines the importance of adequate equipment management to improve the safety in the OR. A system was developed to monitor the safety status (periodic maintenance and registered malfunctions) of OR devices and to facilitate the notification of malfunctions. The objective was to assess whether the system is suitable for use in an busy OR setting and to analyse its effect on the notification of malfunctions. The system checks automatically the safety status of OR devices through constant communication with the technical facility management system, informs the OR staff real-time and facilitates notification of malfunctions. The system was tested for a pilot period of six months in four ORs of a Dutch teaching hospital and 17 users were interviewed on the usability of the system. The users provided positive feedback on the usability. For 86.6% of total time, the localisation of OR devices was accurate. 62 malfunctions of OR devices were reported, an increase of 12 notifications compared to the previous year. The safety status system was suitable for an OR complex, both from a usability and technical point of view, and an increase of reported malfunctions was observed. The system eases monitoring the safety status of equipment and is a promising tool to improve the safety related to OR devices.

NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

1981-01-01

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

Traffic safety facts 1996 : a compilation of motor vehicle crash data from the fatality analysis reporting system and the general estimates system

DOT National Transportation Integrated Search

1997-12-01

This annual report presents descriptive statistics about traffic crashes of all severities, from those that result in property damage to those that result in the loss of human life. Information from two of the National Highway Traffic Safety Administ...

Traffic safety facts 2005 : a compilation of motor vehicle crash data from the fatality analysis reporting system and the general estimates system

DOT National Transportation Integrated Search

2006-01-01

This annual report presents descriptive statistics about traffic crashes of all severities, from those that result in property damage to those that result in the loss of human life. Information from two of the National Highway Traffic Safety Administ...

Traffic safety facts 2006 : a compilation of motor vehicle crash data from the fatality analysis reporting system and the general estimates system

DOT National Transportation Integrated Search

2007-01-01

This annual report presents descriptive statistics about traffic crashes of all severities, from those that result in property damage to those that result in the loss of human life. Information from two of the National Highway Traffic Safety Administ...

Traffic safety facts 2000 : a compilation of motor vehicle crash data from the fatality analysis reporting system and the general estimates system

DOT National Transportation Integrated Search

2001-12-01

This annual report presents descriptive statistics about traffic crashes of all severities, from those that result in property damage to those that result in the loss of human life. Information from two of the National Highway Traffic Safety Administ...

Traffic safety facts 2001 : a compilation of motor vehicle crash data from the fatality analysis reporting system and the general estimates system

DOT National Transportation Integrated Search

2002-12-01

This annual report presents descriptive statistics about traffic crashes of all severities, from those that result in property damage to those that result in the loss of human life. Information from two of the National Highway Traffic Safety Administ...

Traffic safety facts 1998 : a compilation of motor vehicle crash data from the fatality analysis reporting system and the general estimates system

DOT National Transportation Integrated Search

1999-10-01

This annual report presents descriptive statistics about traffic crashes of all severities, from those that result in property damage to those that result in the loss of human life. Information from two of the National Highway Traffic Safety Administ...

Traffic safety facts 2002 : a compilation of motor vehicle crash data from the fatality analysis reporting system and the general estimates system

DOT National Transportation Integrated Search

2004-01-01

This annual report presents descriptive statistics about traffic crashes of all severities, from those that result in property damage to those that result in the loss of human life. Information from two of the National Highway Traffic Safety Administ...

Traffic safety facts 2003 : a compilation of motor vehicle crash data from the fatality analysis reporting system and the general estimates system

DOT National Transportation Integrated Search

2005-01-01

This annual report presents descriptive statistics about traffic crashes of all severities, from those that result in property damage to those that result in the loss of human life. Information from two of the National Highway Traffic Safety Administ...

Traffic safety facts 1999 : a compilation of motor vehicle crash data from the fatality analysis reporting system and the general estimates system

DOT National Transportation Integrated Search

2000-12-01

This annual report presents descriptive statistics about traffic crashes of all severities, from those that result in property damage to those that result in the loss of human life. Information from two of the National Highway Traffic Safety Administ...

Traffic safety facts 1994 : a compilation of motor vehicle crash data from the fatality analysis reporting system and the general estimates system

DOT National Transportation Integrated Search

1995-08-01

This annual report presents descriptive statistics about traffic crashes of all severities, from those that result in property damage to those that result in the loss of human life. Information from two of the National Highway Traffic Safety Administ...

Can Patient Safety Incident Reports Be Used to Compare Hospital Safety? Results from a Quantitative Analysis of the English National Reporting and Learning System Data.

PubMed

Howell, Ann-Marie; Burns, Elaine M; Bouras, George; Donaldson, Liam J; Athanasiou, Thanos; Darzi, Ara

2015-01-01

The National Reporting and Learning System (NRLS) collects reports about patient safety incidents in England. Government regulators use NRLS data to assess the safety of hospitals. This study aims to examine whether annual hospital incident reporting rates can be used as a surrogate indicator of individual hospital safety. Secondly assesses which hospital characteristics are correlated with high incident reporting rates and whether a high reporting hospital is safer than those lower reporting hospitals. Finally, it assesses which health-care professionals report more incidents of patient harm, which report more near miss incidents and what hospital factors encourage reporting. These findings may suggest methods for increasing the utility of reporting systems. This study used a mix methods approach for assessing NRLS data. The data were investigated using Pareto analysis and regression models to establish which patients are most vulnerable to reported harm. Hospital factors were correlated with institutional reporting rates over one year to examine what factors influenced reporting. Staff survey findings regarding hospital safety culture were correlated with reported rates of incidents causing harm; no harm and death to understand what barriers influence error disclosure. 5,879,954 incident reports were collected from acute hospitals over the decade. 70.3% of incidents produced no harm to the patient and 0.9% were judged by the reporter to have caused severe harm or death. Obstetrics and Gynaecology reported the most no harm events [OR 1.61(95%CI: 1.12 to 2.27), p<0.01] and pharmacy was the hospital location where most near-misses were captured [OR 3.03(95%CI: 2.04 to 4.55), p<0.01]. Clinicians were significantly more likely to report death than other staff [OR 3.04(95%CI: 2.43 to 3.80) p<0.01]. A higher ratio of clinicians to beds correlated with reduced rate of harm reported [RR = -1.78(95%Cl: -3.33 to -0.23), p = 0.03]. Litigation claims per bed were significantly negatively associated with incident reports. Patient satisfaction and mortality outcomes were not significantly associated with reporting rates. Staff survey responses revealed that keeping reports confidential, keeping staff informed about incidents and giving feedback on safety initiatives increased reporting rates [r = 0.26 (p<0.01), r = 0.17 (p = 0.04), r = 0.23 (p = 0.01), r = 0.20 (p = 0.02)]. The NRLS is the largest patient safety reporting system in the world. This study did not demonstrate many hospital characteristics to significantly influence overall reporting rate. There were no association between size of hospital, number of staff, mortality outcomes or patient satisfaction outcomes and incident reporting rate. The study did show that hospitals where staff reported more incidents had reduced litigation claims and when clinician staffing is increased fewer incidents reporting patient harm are reported, whilst near misses remain the same. Certain specialties report more near misses than others, and doctors report more harm incidents than near misses. Staff survey results showed that open environments and reduced fear of punitive response increases incident reporting. We suggest that reporting rates should not be used to assess hospital safety. Different healthcare professionals focus on different types of safety incidents and focusing on these areas whilst creating a responsive, confidential learning environment will increase staff engagement with error disclosure.

Database Design to Ensure Anonymous Study of Medical Errors: A Report from the ASIPS collaborative

PubMed Central

Pace, Wilson D.; Staton, Elizabeth W.; Higgins, Gregory S.; Main, Deborah S.; West, David R.; Harris, Daniel M.

2003-01-01

Medical error reporting systems are important information sources for designing strategies to improve the safety of health care. Applied Strategies for Improving Patient Safety (ASIPS) is a multi-institutional, practice-based research project that collects and analyzes data on primary care medical errors and develops interventions to reduce error. The voluntary ASIPS Patient Safety Reporting System captures anonymous and confidential reports of medical errors. Confidential reports, which are quickly de-identified, provide better detail than do anonymous reports; however, concerns exist about the confidentiality of those reports should the database be subject to legal discovery or other security breaches. Standard database elements, for example, serial ID numbers, date/time stamps, and backups, could enable an outsider to link an ASIPS report to a specific medical error. The authors present the design and implementation of a database and administrative system that reduce this risk, facilitate research, and maintain near anonymity of the events, practices, and clinicians. PMID:12925548

Information requirements of the National Aeronautics and Space Administration's safety, environmental health, and occupational medicine programs

NASA Technical Reports Server (NTRS)

Whyte, A. A.

1978-01-01

A survey of the internal and external reporting and recordkeeping procedures of these programs was conducted and the major problems associated with them are outlined. The impact of probable future requirements on existing information systems is evaluated. This report also presents the benefits of combining the safety and health information systems into one computerized system and recommendations for the development and scope of that system.

Do we need a national incident reporting system for medical imaging?

PubMed

Itri, Jason N; Krishnaraj, Arun

2012-05-01

The essential role of an incident reporting system as a tool to improve safety and reliability has been described in high-risk industries such as aviation and nuclear power, with anesthesia being the first medical specialty to successfully integrate incident reporting into a comprehensive quality improvement strategy. Establishing an incident reporting system for medical imaging that effectively captures system errors and drives improvement in the delivery of imaging services is a key component of developing and evaluating national quality improvement initiatives in radiology. Such a national incident reporting system would be most effective if implemented as one piece of a comprehensive quality improvement strategy designed to enhance knowledge about safety, identify and learn from errors, raise standards and expectations for improvement, and create safer systems through implementation of safe practices. The potential benefits of a national incident reporting system for medical imaging include reduced morbidity and mortality, improved patient and referring physician satisfaction, reduced health care expenses and medical liability costs, and improved radiologist satisfaction. The purposes of this article are to highlight the positive impact of external reporting systems, discuss how similar advancements in quality and safety can be achieved with an incident reporting system for medical imaging in the United States, and describe current efforts within the imaging community toward achieving this goal. Copyright © 2012 American College of Radiology. Published by Elsevier Inc. All rights reserved.

78 FR 67212 - Notice of Meeting of the Transit Rail Advisory Committee for Safety (TRACS)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-08

... the safety of public transportation systems. DATES: The TRACS meeting will be held on November 21... Letter Report on the Development of the National Public Transportation Safety Plan (4) Review of the Draft Letter Report on Public Transportation Agency Plans (5) Public Comments (6) Wrap Up As previously...

New initiatives for pharmacovigilance in South Korea: introducing the Korea Institute of Drug Safety and Risk Management (KIDS).

PubMed

Shin, Ju-Young; Jung, Sun-Young; Ahn, So-Hyeon; Lee, Shin Haeng; Kim, Su-Jin; Seong, Jong-Mi; Chung, Soo-Youn; Park, Byung-Joo

2014-11-01

Pharmacovigilance plays a vital role in ensuring that patients receive appropriate medical products that are safe and effective. This paper aims to describe the history of pharmacovigilance in Korea and introduce the establishment and goal of the KIDS. In Korea, the adverse drug reactions (ADR) reporting system was launched in 1988 by the Korea Ministry of Food and Drug Safety (MFDS) and spontaneous ADR reports have been collected from health care professionals and the general public. Although the ADR reporting system has begun, the reporting rate was very low in the first 10 years, and safety actions were done passively in response to the US Food and Drug Administration (FDA) or European Medicines Agency (EMA)'s safety alert and communications. Therefore, the Korea Institute of Drug Safety and Risk Management (KIDS) was established in April 2012 as a new initiative for pharmacovigilance. The KIDS will continue to contribute to the improvement of Korean pharmacovigilance by collecting, managing, and analyzing consumer-centered drug safety information. Copyright © 2014 John Wiley & Sons, Ltd.

Barriers to Implementing a Reporting and Learning Patient Safety System: Pediatric Chiropractic Perspective.

PubMed

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

2016-04-01

A reporting and learning system is a method of monitoring the occurrence of incidents that affect patient safety. This cross-sectional survey asked pediatric chiropractors about factors that may limit their participation in such a system. The list of potential barriers for participation was developed using a systematic approach. All members of the 2 pediatric councils associated with US national chiropractic organizations were invited to complete the survey (N = 400). The cross-sectional survey was created using an online survey tool (REDCap) and sent directly to member emails addressed by the respective executive committees. Of the 400 potential respondents, 81 responded (20.3%). The most common limitations to participating were identified as time pressure (96%) and patient concerns (81%). Reporting and learning systems have been utilized to increase safety awareness in many high-risk industries. To be successful, future patient safety studies with pediatric chiropractors need to ensure these barriers are understood and addressed. © The Author(s) 2015.

Frequency of target crashes for IntelliDrive safety systems

DOT National Transportation Integrated Search

2010-10-01

This report estimates the frequency of different crash types that would potentially be addressed by various categories of Intelligent Transportation Systems as part of the IntelliDriveSM safety systems program. Crash types include light-vehicle crash...

[Measurement and study report as a part of the control system for human safety and health protection against electromagnetic fields and electromagnetic radiation (0 Hz-300 GHz)].

PubMed

Aniołczyk, Halina

2007-01-01

The National Control System for safety and health protection against electromagnetic fields (EMF) and electromagnetic radiation (EMR) (0 Hz-300 GHz) is constantly analyzed in view of Directive 2004/40/EC. Reports on the effects of investments (at the designing stage or at the stage of looking for their localization) on the environment and measurement and study reports on the objects already existing or being put into operation are important elements of this system. These documents should meet both national and European Union's legislation requirements. The overriding goal of the control system is safety and health protection of humans against electromagnetic fields in the environment and in occupational settings. The author pays a particular attention to provisions made in directives issued by relevant ministers and to Polish standards, which should be documented in measurement and study reports published by the accredited laboratories and relating to the problems of human safety and health protection. Similar requirements are valid for the Reports. Therefore, along with measurement outcomes, the reports should include data on the EMF exposure classification at work-posts and the assessment of occupational risk resulting from EMF exposure or at least thorough data facilitating such a classification.

2013 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

Dumont, Alan G.

2013-01-01

Welcome to the 2013 edition of the NASA Range Safety Annual Report. Funded by NASA Headquarters, this report provides an Agency overview for current and potential range users. This report contains articles which cover a variety of subject areas, summaries of various activities performed during the past year, links to past reports, and information on several projects that may have a profound impact on the way business will be conducted in the future. Specific topics discussed in the 2013 NASA Range Safety Annual Report include a program overview and 2013 highlights, Range Safety Training, Independent Assessments, support to Program Operations at all ranges conducting NASA launch/flight operations, a continuing overview of emerging range safety-related technologies, and status reports from all of the NASA Centers that have Range Safety responsibilities. Every effort has been made to include the most current information available. We recommend this report be used only for guidance and that the validity and accuracy of all articles be verified for updates. As is the case each year, we had a wide variety of contributors to this report from across our NASA Centers and the national range safety community at large, and I wish to thank them all. On a sad note, we lost one of our close colleagues, Dr. Jim Simpson, due to his sudden passing in December. His work advancing the envelope of autonomous flight safety systems software/hardware development leaves a lasting impression on our community. Such systems are being flight tested today and may one day be considered routine in the range safety business. The NASA family has lost a pioneer in our field, and he will surely be missed. In conclusion, it has been a very busy and productive year, and I look forward to working with all of you in NASA Centers/Programs/Projects and with the national Range Safety community in making Flight/Space activities as safe as they can be in the upcoming year.

Systematic control of nonmetallic materials for improved fire safety

NASA Technical Reports Server (NTRS)

1972-01-01

The elements of a systematic fire safety program are summarized and consist of fire safety criteria, design considerations, testing of materials, development of nonmetallic materials, nonmetallic materials information systems, design reviews, and change control. The system described in this report was developed for the Apollo spacecraft. The system can, however, be tailored to many industrial, commercial, and military activities.

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

PubMed

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 < .001). This card-based 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 important preferences and priorities for reporting medical errors and patient safety events.

Model-Based Safety Analysis

NASA Technical Reports Server (NTRS)

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

2006-01-01

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

Prototype Input and Output Data Elements for the Occupational Health and Safety Information System

NASA Technical Reports Server (NTRS)

Whyte, A. A.

1980-01-01

The National Aeronautics and Space Administration plans to implement a NASA-wide computerized information system for occupational health and safety. The system is necessary to administer the occupational health and safety programs and to meet the legal and regulatory reporting, recordkeeping, and surveillance requirements. Some of the potential data elements that NASA will require as input and output for the new occupational health and safety information system are illustrated. The data elements are shown on sample forms that have been compiled from various sources, including NASA Centers and industry.

Aviation safety data accessibility study index: a report on the issues related to public interest in aviation safety data

DOT National Transportation Integrated Search

1997-01-20

This paper reviews aviation safety data and measurement issues relevant to the determination of the best means of providing safety information to the public while ensuring the integrity of the aviation safety system. In addition , the paper examines ...

Models Extracted from Text for System-Software Safety Analyses

NASA Technical Reports Server (NTRS)

Malin, Jane T.

2010-01-01

This presentation describes extraction and integration of requirements information and safety information in visualizations to support early review of completeness, correctness, and consistency of lengthy and diverse system safety analyses. Software tools have been developed and extended to perform the following tasks: 1) extract model parts and safety information from text in interface requirements documents, failure modes and effects analyses and hazard reports; 2) map and integrate the information to develop system architecture models and visualizations for safety analysts; and 3) provide model output to support virtual system integration testing. This presentation illustrates the methods and products with a rocket motor initiation case.

The Federal Aviation Administration Plan for Research, Engineering and Development. Volume 1. Program Plan

DTIC Science & Technology

1989-01-01

Mid * Advanced Propulsion System Far * Rotor Burst Protection Reports Mid 11.4 Flight Safety / * Aircraft Icing Handbook Near Atmospheric Hazards...with operating the national aviation system include air traffic controllers, flight service specialists, maintenance technicians, safety inspectors...address the design and certification of flight deck systems and revised crew training requirements. In FY 1988, studies of safety data were initiated to

Viewpoint on ISA TR84.0.02--simplified methods and fault tree analysis.

PubMed

Summers, A E

2000-01-01

ANSI/ISA-S84.01-1996 and IEC 61508 require the establishment of a safety integrity level for any safety instrumented system or safety related system used to mitigate risk. Each stage of design, operation, maintenance, and testing is judged against this safety integrity level. Quantitative techniques can be used to verify whether the safety integrity level is met. ISA-dTR84.0.02 is a technical report under development by ISA, which discusses how to apply quantitative analysis techniques to safety instrumented systems. This paper discusses two of those techniques: (1) Simplified equations and (2) Fault tree analysis.

Patient safety problem identification and solution sharing among rural community pharmacists.

PubMed

Galt, Kimberly A; Fuji, Kevin T; Faber, Jennifer

2013-01-01

To implement a communication network for safety problem identification and solution sharing among rural community pharmacists and to report participating pharmacists' perceived value and impact of the network on patient safety after 1 year of implementation. Action research study. Rural community pharmacies in Nebraska from January 2010 to April 2011. Rural community pharmacists who voluntarily agreed to join the Pharmacists for Patient Safety Network in Nebraska. Pharmacists reported errors, near misses, and safety concerns through Web-based event reporting. A rapid feedback process was used to provide patient safety solutions to consider implementing across the network. Qualitative interviews were conducted 1 year after program implementation with participating pharmacists to assess use of the reporting system, value of the disseminated safety solutions, and perceived impact on patient safety in pharmacies. 30 of 38 pharmacists participating in the project completed the interviews. The communication network improved pharmacist awareness, promoted open discussion and knowledge sharing, contributed to practice vigilance, and led to incorporation of proactive safety prevention practices. Despite low participation in error and near-miss reporting, a dynamic communication network designed to rapidly disseminate evidence-based patient safety strategies to reduce risk was valued and effective at improving patient safety practices in rural community pharmacies.

Integrated Vehicle-Based Safety Systems (IVBSS) Light Vehicle Field Operational Test Independent Evaluation

DOT National Transportation Integrated Search

2011-10-01

This report presents the methodology and results of the independent evaluation of a prototype integrated crash warning system for : light vehicles as part of the Integrated Vehicle-Based Safety Systems initiative of the United States Department of : ...

75 FR 52587 - 2009 Fatality Analysis Reporting System (FARS)/National Automotive Sampling System General...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-26

... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration [U.S. DOT Docket Number NHTSA-2010-0122] 2009 Fatality Analysis Reporting System (FARS)/National Automotive Sampling... Administration (NHTSA)--2009 Fatality Analysis Reporting System (FARS) & National Automotive Sampling System...

Automating the Generation of Heterogeneous Aviation Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Pai, Ganesh J.; Pohl, Josef M.

2012-01-01

A safety case is a structured argument, supported by a body of evidence, which provides a convincing and valid justification that a system is acceptably safe for a given application in a given operating environment. This report describes the development of a fragment of a preliminary safety case for the Swift Unmanned Aircraft System. The construction of the safety case fragment consists of two parts: a manually constructed system-level case, and an automatically constructed lower-level case, generated from formal proof of safety-relevant correctness properties. We provide a detailed discussion of the safety considerations for the target system, emphasizing the heterogeneity of sources of safety-relevant information, and use a hazard analysis to derive safety requirements, including formal requirements. We evaluate the safety case using three classes of metrics for measuring degrees of coverage, automation, and understandability. We then present our preliminary conclusions and make suggestions for future work.

Developing a smartphone based warning system application to enhance the safety at work zones : final report.

DOT National Transportation Integrated Search

2016-05-01

Collisions in the work zone have always been a contributing factor to compromising safety on urban roadways. The National Highway Traffic Safety Administration (NHTSA) and the State Transportation Authorities have implemented many safety countermeasu...

Kentucky commercial vehicle safety applications evaluation : technical report.

DOT National Transportation Integrated Search

2008-01-31

An advanced-technology Integrated Safety and Security Enforcement System (ISSES), now deployed at three commercial vehicle inspection sites along interstate highways in Kentucky, was evaluated from the point of view of system performance, potential e...

Safety management of a complex R&D ground operating system

NASA Technical Reports Server (NTRS)

Connors, J.; Mauer, R. A.

1975-01-01

Report discusses safety program implementation for large R&D operating system. Analytical techniques are defined and suggested as tools for identifying potential hazards and determining means to effectively control or eliminate hazards.

ASAP Aerospace Safety Advisory Panel

NASA Technical Reports Server (NTRS)

2004-01-01

This is the First Quarterly Report for the newly reconstituted Aerospace Safety Advisory Panel (ASAP). The NASA Administrator rechartered the Panel on November 18,2003, to provide an independent, vigilant, and long-term oversight of NASA's safety policies and programs well beyond Return to Flight of the Space Shuttle. The charter was revised to be consistent with the original intent of Congress in enacting the statute establishing ASAP in 1967 to focus on NASA's safety and quality systems, including industrial and systems safety, risk-management and trend analysis, and the management of these activities.The charter also was revised to provide more timely feedback to NASA by requiring quarterly rather than annual reports, and by requiring ASAP to perform special assessments with immediate feedback to NASA. ASAP was positioned to help institutionalize the safety culture of NASA in the post- Stafford-Covey Return to Flight environment.

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

PubMed

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.

A Fire Safety Certification System for Board and Care Operators and Staff. SBIR Phase I: Final Report.

ERIC Educational Resources Information Center

Walker, Bonnie L.

This report describes the development and pilot testing of a fire safety certification system for board and care operators and staff who serve clients with developmental disabilities. During Phase 1, training materials were developed, including a trainer's manual, a participant's coursebook a videotape, an audiotape, and a pre-/post test which was…

A Fire Safety Certification System for Board and Care Operators and Staff. SBIR Phase II: Final Report.

ERIC Educational Resources Information Center

Walker, Bonnie L.

This report describes Phase II of a project which developed a system for delivering fire safety training to board and care providers who serve adults with developmental disabilities. Phase II focused on developing and pilot testing a "train the trainers" workshop for instructors and field testing the provider's workshop. Evaluation of…

Influence Map Methodology for Evaluating Systemic Safety Issues

NASA Technical Reports Server (NTRS)

2008-01-01

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

Early warning reporting categories analysis of recall and complaints data.

DOT National Transportation Integrated Search

2001-12-31

This analysis was performed to assist the National Highway Traffic Safety Administration (NHTSA) in identifying components and systems to be included in early warning reporting (EWR) categories that would be based upon historical safety-related recal...

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

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

Kapoor, R; Palta, J; Hagan, M

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 missmore » 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 Inc. and is deployed on the VA intranet as a Website. The Radiation Oncology Incident Reporting and Learning System software used for this program has been developed, conceptualized and maintained by TSG Innovations Inc. and is deployed on the VA intranet as a Website.« less

Assessment of documentation requirements under DOE 5481. 1, Safety Analysis and Review System (SARS)

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

Browne, E.T.

1981-03-01

This report assesses the requirements of DOE Order 5481.1, Safety Analysis and Review System for DOE Operations (SARS) in regard to maintaining SARS documentation. Under SARS, all pertinent details of the entire safety analysis and review process for each DOE operation are to be traceable from the initial identification of a hazard. This report is intended to provide assistance in identifying the points in the SARS cycle at which documentation is required, what type of documentation is most appropriate, and where it ultimately should be maintained.

78 FR 77554 - Reports, Forms and Record Keeping Requirements; Agency Information Collection Activity Under OMB...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-23

... information described is the ``Consolidated Child Restraint System Registration, Labeling and Defect...: National Highway Traffic Safety Administration Title: Consolidated Child Restraint System Registration... the Federal motor vehicle safety standard for child restraint systems (CRSs) to expand its...

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

PubMed

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

2013-04-01

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

Safety restraint use in Virginia : use rate trends from 1983 through 1995.

DOT National Transportation Integrated Search

1996-01-01

The purpose of this report was to take a retrospective glance at Virginia's experience in getting her citizens to use the automobile safety restraint systems available to them. In Virginia, data on safety belt and child safety seat use were collected...

Integrated vehicle-based safety systems : third annual report.

DOT National Transportation Integrated Search

2009-10-01

The Integrated Vehicle-Based Safety Systems (IVBSS) program is a five-year, two-phase cooperative : research program being conducted by an industry consortium led by the University of Michigan : Transportation Research Institute (UMTRI). The goal of ...

Integrated Vehicle-Based Safety Systems Third Annual Report

DOT National Transportation Integrated Search

2009-10-01

The Integrated Vehicle-Based Safety Systems (IVBSS) program is a five-year, two-phase cooperative research program being conducted by an industry consortium led by the University of Michigan Transportation Research Institute (UMTRI). The goal of the ...

Safety of High Speed Guided Ground Transportation Systems: Work Breakdown Structure

DOT National Transportation Integrated Search

1994-11-30

This report provides a systems approach to the assessment, evaluation and application of high-speed guided ground transportation (HSGGT) safety criteria and : presents one potential methodology by combining a work breakdown structure (WBS) : approach...

Estimation of potential safety benefits for pedestrian crash avoidance/mitigation systems.

DOT National Transportation Integrated Search

2017-04-01

This report presents and exercises a methodology to estimate the effectiveness and potential safety benefits of production pedestrian crash avoidance/mitigation systems. The analysis focuses on light vehicles moving forward and striking a pedestrian ...

33 CFR 169.110 - When is the northeastern reporting system in effect?

Code of Federal Regulations, 2010 CFR

2010-07-01

... reporting system in effect? 169.110 Section 169.110 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY SHIP REPORTING SYSTEMS Establishment of Two Mandatory Ship Reporting Systems for the Protection of Northern Right Whales § 169.110 When is the...

33 CFR 169.120 - When is the southeastern reporting system in effect?

Code of Federal Regulations, 2010 CFR

2010-07-01

... reporting system in effect? 169.120 Section 169.120 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY SHIP REPORTING SYSTEMS Establishment of Two Mandatory Ship Reporting Systems for the Protection of Northern Right Whales § 169.120 When is the...

Fusion Safety Program annual report, fiscal year 1994

NASA Astrophysics Data System (ADS)

Longhurst, Glen R.; Cadwallader, Lee C.; Dolan, Thomas J.; Herring, J. Stephen; McCarthy, Kathryn A.; Merrill, Brad J.; Motloch, Chester C.; Petti, David A.

1995-03-01

This report summarizes the major activities of the Fusion Safety Program in fiscal year 1994. The Idaho National Engineering Laboratory (INEL) is the designated lead laboratory and Lockheed Idaho Technologies Company is the prime contractor for this program. The Fusion Safety Program was initiated in 1979. Activities are conducted at the INEL, at other DOE laboratories, and at other institutions, including the University of Wisconsin. The technical areas covered in this report include tritium safety, beryllium safety, chemical reactions and activation product release, safety aspects of fusion magnet systems, plasma disruptions, risk assessment failure rate data base development, and thermalhydraulics code development and their application to fusion safety issues. Much of this work has been done in support of the International Thermonuclear Experimental Reactor (ITER). Also included in the report are summaries of the safety and environmental studies performed by the Fusion Safety Program for the Tokamak Physics Experiment and the Tokamak Fusion Test Reactor and of the technical support for commercial fusion facility conceptual design studies. A major activity this year has been work to develop a DOE Technical Standard for the safety of fusion test facilities.

Safety Management Information Statistics (SAMIS) - 1990 Annual Report.

DOT National Transportation Integrated Search

1992-04-01

The report is a compilation and analysis of mass transit accident and casualty statistics reported by transit systems in the United States during 1990, under the Federal Transit Administration's (FTA's) Section 15 reporting system.

2015 Accomplishments Report

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

None, None

This report covers selected highlights from the four research pathways in the LWRS Program: Materials Aging and Degradation; Risk-Informed Safety Margin Characterization; Advanced Instrumentation, Information, and Control Systems Technologies; and Reactor Safety Technologies, as well as a look-ahead at planned activities for 2017.

2016 Accomplishments Report

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

None, None

This report covers selected highlights from the four research pathways in the LWRS Program: Materials Aging and Degradation; Risk-Informed Safety Margin Characterization; Advanced Instrumentation, Information, and Control Systems Technologies; and Reactor Safety Technologies, as well as a look-ahead at planned activities for 2017.

An analysis of electronic health record-related patient safety concerns

PubMed Central

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

2014-01-01

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

75 FR 5640 - Pipeline Safety: Implementation of Revised Incident/Accident Report Forms for Distribution...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-03

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No... Distribution Systems, Gas Transmission and Gathering Systems, and Hazardous Liquid Systems AGENCY: Pipeline and.... SUMMARY: This notice advises owners and operators of gas pipeline facilities and hazardous liquid pipeline...

SER assistant: An expert system for safety evaluation reports

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

DeChaine, M.D.; Levine, S.H.; Feltus, M.A.

1993-01-01

The SER Assistant is an expert system that assists engineers to write safety evaluation reports (SERs). Section 50.59 of the Code of Federal Regulations allows modifications to be made to nuclear power plants without prior US Nuclear Regulatory Commission approval if two conditions are satisfied. First, the change must not affect the technical specifications of the plant. Second, the modification must not affect a part of the plant described in the final safety analysis report, or if it does, it must not create an unreviewed safety question. The purpose of an SER is to ensure that these conditions are satisfiedmore » for the proposed modification. The SER Assistant aids this process by providing relevant, but directed, questions and information as well as giving engineers an organized environment to document their thought processes.« less

The elements of a commercial human spaceflight safety reporting system

NASA Astrophysics Data System (ADS)

Christensen, Ian

2017-10-01

In its report on the SpaceShipTwo accident the National Transportation Safety Board (NTSB) included in its recommendations that the Federal Aviation Administration (FAA) ;in collaboration with the commercial spaceflight industry, continue work to implement a database of lessons learned from commercial space mishap investigations and encourage commercial space industry members to voluntarily submit lessons learned.; In its official response to the NTSB the FAA supported this recommendation and indicated it has initiated an iterative process to put into place a framework for a cooperative safety data sharing process including the sharing of lessons learned, and trends analysis. Such a framework is an important element of an overall commercial human spaceflight safety system.

From aviation to medicine: applying concepts of aviation safety to risk management in ambulatory care.

PubMed

Wilf-Miron, R; Lewenhoff, I; Benyamini, Z; Aviram, A

2003-02-01

The development of a medical risk management programme based on the aviation safety approach and its implementation in a large ambulatory healthcare organisation is described. The following key safety principles were applied: (1). errors inevitably occur and usually derive from faulty system design, not from negligence; (2). accident prevention should be an ongoing process based on open and full reporting; (3). major accidents are only the "tip of the iceberg" of processes that indicate possibilities for organisational learning. Reporting physicians were granted immunity, which encouraged open reporting of errors. A telephone "hotline" served the medical staff for direct reporting and receipt of emotional support and medical guidance. Any adverse event which had learning potential was debriefed, while focusing on the human cause of error within a systemic context. Specific recommendations were formulated to rectify processes conducive to error when failures were identified. During the first 5 years of implementation, the aviation safety concept and tools were successfully adapted to ambulatory care, fostering a culture of greater concern for patient safety through risk management while providing support to the medical staff.

From aviation to medicine: applying concepts of aviation safety to risk management in ambulatory care

PubMed Central

Wilf-Miron, R; Lewenhoff, I; Benyamini, Z; Aviram, A

2003-01-01



 The development of a medical risk management programme based on the aviation safety approach and its implementation in a large ambulatory healthcare organisation is described. The following key safety principles were applied: (1) errors inevitably occur and usually derive from faulty system design, not from negligence; (2) accident prevention should be an ongoing process based on open and full reporting; (3) major accidents are only the "tip of the iceberg" of processes that indicate possibilities for organisational learning. Reporting physicians were granted immunity, which encouraged open reporting of errors. A telephone "hotline" served the medical staff for direct reporting and receipt of emotional support and medical guidance. Any adverse event which had learning potential was debriefed, while focusing on the human cause of error within a systemic context. Specific recommendations were formulated to rectify processes conducive to error when failures were identified. During the first 5 years of implementation, the aviation safety concept and tools were successfully adapted to ambulatory care, fostering a culture of greater concern for patient safety through risk management while providing support to the medical staff. PMID:12571343

Correlated Topics in a Scalable Multidimensional Text Cube: Algorithms and Aviation Safety Case Study

NASA Technical Reports Server (NTRS)

Zhao, Bo; Lin, Cindy X.; Srivastava, Ashok N.; Oza, Nikunj C.; Han, Jiawei

2010-01-01

As world-wide air traffic continues to grow even at a modest pace, the overall complexity of the system will increase significantly. This increased complexity can lead to a larger number of fatalities per year even if the extremely low fatality rate that we currently enjoy is maintained. One important source of information about the safety of the aviation system is in Aviation Safety Text Reports which are written by members of the flight crew, air traffic controllers, and other parties involved with the aviation system. These anonymized narrative reports contain fixed-field contextual information about the flight but also contain free-form narratives that describe, in the author s own words, the nature of the safety incident and, in many cases, the contributing factors that led to the safety incident. Several thousand such reports are filed each month, each of which is read and analyzed by highly trained experts. However, it is possible that there are emerging safety issues due to the fact that they may be reported very infrequently and in different contexts with different descriptions. The goal of this research paper is to develop correlated topic models which uncover correlations in the subspaces defined by the intersection of numerous fixed fields and discovered correlated topics. This task requires the discovery of latent topics in the text reports and the creation of a topic cube. Furthermore, because the number of potential cells in the topic cube is very large, we discuss novel methods of pruning the search space in the topic cells, thereby making the analysis feasible. We demonstrate the new algorithms on an analysis of pilot fatigue and its contributing factors, as well as the safety incidents that are correlated with this phenomenon.

Improving Patient Safety in Public Hospitals: Developing Standard Measures to Track Medical Errors and Process Breakdowns.

PubMed

Ackerman, Sara L; Gourley, Gato; Le, Gem; Williams, Pamela; Yazdany, Jinoos; Sarkar, Urmimala

2018-03-14

The aim of the study was to develop standards for tracking patient safety gaps in ambulatory care in safety net health systems. Leaders from five California safety net health systems were invited to participate in a modified Delphi process sponsored by the Safety Promotion Action Research and Knowledge Network (SPARKNet) and the California Safety Net Institute in 2016. During each of the three Delphi rounds, the feasibility and validity of 13 proposed patient safety measures were discussed and prioritized. Surveys and transcripts from the meetings were analyzed to understand the decision-making process. The Delphi process included eight panelists. Consensus was reached to adopt 9 of 13 proposed measures. All 9 measures were unanimously considered valid, but concern was expressed about the feasibility of implementing several of the measures. Although safety net health systems face high barriers to standardized measurement, our study demonstrates that consensus can be reached on acceptable and feasible methods for tracking patient safety gaps in safety net health systems. If accompanied by the active participation key stakeholder groups, including patients, clinicians, staff, data system professionals, and health system leaders, the consensus measures reported here represent one step toward improving ambulatory patient safety in safety net health systems.

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

Nyflot, MJ; Kusano, AS; Zeng, J

Purpose: Interest in incident learning systems (ILS) for improving safety and quality in radiation oncology is growing, as evidenced by the upcoming release of the national ILS. However, an institution implementing such a system would benefit from quantitative metrics to evaluate performance and impact. We developed metrics to measure volume of reporting, severity of reported incidents, and changes in staff attitudes over time from implementation of our institutional ILS. Methods: We analyzed 2023 incidents from our departmental ILS from 2/2012–2/2014. Incidents were prospectively assigned a near-miss severity index (NMSI) at multidisciplinary review to evaluate the potential for error ranging frommore » 0 to 4 (no harm to critical). Total incidents reported, unique users reporting, and average NMSI were evaluated over time. Additionally, departmental safety attitudes were assessed through a 26 point survey adapted from the AHRQ Hospital Survey on Patient Safety Culture before, 12 months, and 24 months after implementation of the incident learning system. Results: Participation in the ILS increased as demonstrated by total reports (approximately 2.12 additional reports/month) and unique users reporting (0.51 additional users reporting/month). Also, the average NMSI of reports trended lower over time, significantly decreasing after 12 months of reporting (p<0.001) but with no significant change at months 18 or 24. In survey data significant improvements were noted in many dimensions, including perceived barriers to reporting incidents such as concern of embarrassment (37% to 18%; p=0.02) as well as knowledge of what incidents to report, how to report them, and confidence that these reports were used to improve safety processes. Conclusion: Over a two-year period, our departmental ILS was used more frequently, incidents became less severe, and staff confidence in the system improved. The metrics used here may be useful for other institutions seeking to create or evaluate their own incident learning systems.« less

Summary and evaluation of responses received on the alcohol safety interlock system

DOT National Transportation Integrated Search

1971-05-01

This report summarizes and evaluates devices and suggestions provided by respondents to the DOT Prospectus entitled "Some Considerations Related to the Development of an Alcohol Safety Interlock System (ASIS)". The responses are categorized into: (1)...

Laboratory evaluation of alcohol safety interlock systems. Volume 2 : instrument screening experiments

DOT National Transportation Integrated Search

1974-01-01

The report contains the results of an experimental and analytical evaluation of instruments and techniques designed to prevent an intoxicated driver from operating his automobile. The prototype 'Alcohol Safety Interlock Systems' tested were developed...

Integrated vehicle-based safety systems : first annual report

DOT National Transportation Integrated Search

2007-10-01

The IVBSS (Integrated Vehicle-Based Safety Systems) program is a four-year, two phase cooperative research program being conducted by an industry team led by the University of Michigan Transportation Research Institute (UMTRI). The program began in N...

Proving autonomous vehicle and advanced driver assistance systems safety : final research report.

DOT National Transportation Integrated Search

2016-02-15

The main objective of this project was to provide technology for answering : crucial safety and correctness questions about verification of autonomous : vehicle and advanced driver assistance systems based on logic. : In synergistic activities, we ha...

EHR Safety: The Way Forward to Safe and Effective Systems

PubMed Central

Walker, James M.; Carayon, Pascale; Leveson, Nancy; Paulus, Ronald A.; Tooker, John; Chin, Homer; Bothe, Albert; Stewart, Walter F.

2008-01-01

Diverse stakeholders—clinicians, researchers, business leaders, policy makers, and the public—have good reason to believe that the effective use of electronic health care records (EHRs) is essential to meaningful advances in health care quality and patient safety. However, several reports have documented the potential of EHRs to contribute to health care system flaws and patient harm. As organizations (including small hospitals and physician practices) with limited resources for care-process transformation, human-factors engineering, software safety, and project management begin to use EHRs, the chance of EHR-associated harm may increase. The authors propose a coordinated set of steps to advance the practice and theory of safe EHR design, implementation, and continuous improvement. These include setting EHR implementation in the context of health care process improvement, building safety into the specification and design of EHRs, safety testing and reporting, and rapid communication of EHR-related safety flaws and incidents. PMID:18308981

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

NASA Technical Reports Server (NTRS)

McGreevy, Michael W.

1996-01-01

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

International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of Food and Drug Administration Regional Implementation Specifications for ICH E2B(R3) Reporting to the Food and Drug Administration Adverse Event Reporting System. Notice of Availability.

PubMed

2016-06-23

The Food and Drug Administration (FDA) is announcing the availability of its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonisation (ICH) E2B(R3) Specification. FDA is making this technical specifications document available to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This document, entitled "FDA Regional Implementation Specifications for ICH E2B(R3) Implementation: Postmarket Submission of Individual Case Safety Reports (ICSRs) for Drugs and Biologics, Excluding Vaccines" supplements the "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide--Data Elements and Message Specification" final guidance for industry and describes FDA's technical approach for receiving ICSRs, for incorporating regionally controlled terminology, and for adding region-specific data elements when reporting to FAERS.

Next level of board accountability in health care quality.

PubMed

Pronovost, Peter J; Armstrong, C Michael; Demski, Renee; Peterson, Ronald R; Rothman, Paul B

2018-03-19

Purpose The purpose of this paper is to offer six principles that health system leaders can apply to establish a governance and management system for the quality of care and patient safety. Design/methodology/approach Leaders of a large academic health system set a goal of high reliability and formed a quality board committee in 2011 to oversee quality and patient safety everywhere care was delivered. Leaders of the health system and every entity, including inpatient hospitals, home care companies, and ambulatory services staff the committee. The committee works with the management for each entity to set and achieve quality goals. Through this work, the six principles emerged to address management structures and processes. Findings The principles are: ensure there is oversight for quality everywhere care is delivered under the health system; create a framework to organize and report the work; identify care areas where quality is ambiguous or underdeveloped (i.e. islands of quality) and work to ensure there is reporting and accountability for quality measures; create a consolidated quality statement similar to a financial statement; ensure the integrity of the data used to measure and report quality and safety performance; and transparently report performance and create an explicit accountability model. Originality/value This governance and management system for quality and safety functions similar to a finance system, with quality performance documented and reported, data integrity monitored, and accountability for performance from board to bedside. To the authors' knowledge, this is the first description of how a board has taken this type of systematic approach to oversee the quality of care.

Report: U.S. Chemical Safety and Hazard Investigation Board Needs to Complete More Timely Investigations

EPA Pesticide Factsheets

Report #13-P-0337, July 30, 2013. CSB does not have an effective management system to meet its established performance goal to “conduct incident investigations and safety studies concerning releases of hazardous chemical substances.”

SY Tank Farm ventilation isolation option risk assessment report

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

Powers, T.B.; Morales, S.D.

The safety of the 241-SY Tank Farm ventilation system has been under extensive scrutiny due to safety concerns associated with tank 101-SY. Hydrogen and other gases are generated and trapped in the waste below the liquid surface. Periodically, these gases are released into the dome space and vented through the exhaust system. This attention to the ventilation system has resulted in the development of several alternative ventilation system designs. The ventilation system provides the primary means of mitigation of accidents associated with flammable gases. This report provides an assessment of various alternatives ventilation system designs.

Review of Aircraft Crash Databases and Evaluation of the Probability of Aircraft Crashes on to a MAGLEV Guide-way: Technical Report

DOT National Transportation Integrated Search

1991-12-09

The System Safety & Security Division at The Volpe National Transportation System Center (VNTSC), Cambridge, MA is participating in an overall risk assessment study on the safety of High Speed Magnetic Levitation Transportation Systems ("MagLev"). Tr...

Implementation of a critical incident reporting system in a neurosurgical department.

PubMed

Kantelhardt, P; Müller, M; Giese, A; Rohde, V; Kantelhardt, S R

2011-02-01

Critical incident monitoring is an important tool for quality improvement and the maintenance of high safety standards. It was developed for aviation safety and is now widely accepted as a useful tool to reduce medical care-related morbidity and mortality. Despite this widespread acceptance, the literature has no reports on any neurosurgical applications of critical incident monitoring. We describe the introduction of a mono-institutional critical incident reporting system in a neurosurgical department. Furthermore, we have developed a formula to assess possible counterstrategies. All staff members of a neurosurgical department were advised to report critical incidents. The anonymous reporting form contained a box for the description of the incident, several multiple-choice questions on specific risk factors, place and reason for occurrence of the incident, severity of the consequences and suggested counterstrategies. The incident data was entered into an online documentation system (ADKA DokuPik) and evaluated by an external specialist. For data analysis we applied a modified assessment scheme initially designed for flight safety. Data collection was started in September 2008. The average number of reported incidents was 18 per month (currently 216 in total). Most incidents occurred on the neurosurgical ward (64%). Human error was involved in 86% of the reported incidents. The largest group of incidents consisted of medication-related problems. Accordingly, counterstrategies were developed, resulting in a decrease in the relative number of reported medication-related incidents from 42% (March 09) to 30% (September 09). Implementation of the critical incident reporting system presented no technical problems. The reporting rate was high compared to that reported in the current literature. The formulation, evaluation and introduction of specific counterstrategies to guard against selected groups of incidents may improve patient safety in neurosurgical departments. © Georg Thieme Verlag KG Stuttgart · New York.

Integrating Safety in the Aviation System: Interdepartmental Training for Pilots and Maintenance Technicians

NASA Technical Reports Server (NTRS)

Mattson, Marifran; Petrin, Donald A.; Young, John P.

2001-01-01

The study of human factors has had a decisive impact on the aviation industry. However, the entire aviation system often is not considered in researching, training, and evaluating human factors issues especially with regard to safety. In both conceptual and practical terms, we argue for the proactive management of human error from both an individual and organizational systems perspective. The results of a multidisciplinary research project incorporating survey data from professional pilots and maintenance technicians and an exploratory study integrating students from relevant disciplines are reported. Survey findings suggest that latent safety errors may occur during the maintenance discrepancy reporting process because pilots and maintenance technicians do not effectively interact with one another. The importance of interdepartmental or cross-disciplinary training for decreasing these errors and increasing safety is discussed as a primary implication.

76 FR 28326 - Pipeline Safety: National Pipeline Mapping System Data Submissions and Submission Dates for Gas...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-17

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR 191... Reports AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Issuance of... Pipeline and Hazardous Materials Safety Administration (PHMSA) published a final rule on November 26, 2010...

Nurses' Perceptions of the Impact of Work Systems and Technology on Patient Safety during the Medication Administration Process

ERIC Educational Resources Information Center

Gallagher Gordon, Mary

2012-01-01

This dissertation examines nurses' perceptions of the impacts of systems and technology utilized during the medication administration process on patient safety and the culture of medication error reporting. This exploratory research study was grounded in a model of patient safety based on Patricia Benner's Novice to Expert Skill Acquisition model,…

The Role and Quality of Software Safety in the NASA Constellation Program

NASA Technical Reports Server (NTRS)

Layman, Lucas; Basili, Victor R.; Zelkowitz, Marvin V.

2010-01-01

In this study, we examine software safety risk in the early design phase of the NASA Constellation spaceflight program. Obtaining an accurate, program-wide picture of software safety risk is difficult across multiple, independently-developing systems. We leverage one source of safety information, hazard analysis, to provide NASA quality assurance managers with information regarding the ongoing state of software safety across the program. The goal of this research is two-fold: 1) to quantify the relative importance of software with respect to system safety; and 2) to quantify the level of risk presented by software in the hazard analysis. We examined 154 hazard reports created during the preliminary design phase of three major flight hardware systems within the Constellation program. To quantify the importance of software, we collected metrics based on the number of software-related causes and controls of hazardous conditions. To quantify the level of risk presented by software, we created a metric scheme to measure the specificity of these software causes. We found that from 49-70% of hazardous conditions in the three systems could be caused by software or software was involved in the prevention of the hazardous condition. We also found that 12-17% of the 2013 hazard causes involved software, and that 23-29% of all causes had a software control. Furthermore, 10-12% of all controls were software-based. There is potential for inaccuracy in these counts, however, as software causes are not consistently scoped, and the presence of software in a cause or control is not always clear. The application of our software specificity metrics also identified risks in the hazard reporting process. In particular, we found a number of traceability risks in the hazard reports may impede verification of software and system safety.

Options for enhancing the effectiveness of Virginia's safety management system : final report.

DOT National Transportation Integrated Search

1996-02-01

In 1993, Virginia began to formalize the relationships and organizational structure for its Safety Management System (SMS). Although the SMS is no longer a federal requirement, Virginia decided to continue its implementation. The Focal Point for the ...

A Practical Risk Assessment Methodology for Safety-Critical Train Control Systems

DOT National Transportation Integrated Search

2009-07-01

This project proposes a Practical Risk Assessment Methodology (PRAM) for analyzing railroad accident data and assessing the risk and benefit of safety-critical train control systems. This report documents in simple steps the algorithms and data input...

Laboratory evaluation of alcohol safety interlock systems. Volume 3 : instrument performance at high BAL

DOT National Transportation Integrated Search

1974-01-01

This report contains the results of an experimental and analytical evaluation of instruments and techniques designed to prevent an intoxicated driver from operating his automobile. The prototype 'Alcohol Safety Interlock Systems' tested were develope...

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

Hagen, E.W.

This report reviews and evaluates the performance of the compressed-air and pressurized-nitrogen gas systems in commercial nuclear power units. The information was collected from readily available operating experiences, licensee event reports, system designs in safety analysis reports, and regulatory documents. The results are collated and analyzed for significance and impact on power plant safety performance. Under certain circumstances, the fail-safe philosophy for a piece of equipment or subsystem of the compressed-air systems initiated a series of actions culminating in reactor transient or unit scram. However, based on this study of prevailing operating experiences, reclassifying the compressed-gas systems to a highermore » safety level will neither prevent (nor mitigate) the reoccurrences of such happenings nor alleviate nuclear power plant problems caused by inadequate maintenance, operating procedures, and/or practices. Conversely, because most of the problems were derived from the sources listed previously, upgrading of both maintenance and operating procedures will not only result in substantial improvement in the performance and availability of the compressed-air (and backup nitrogen) systems but in improved overall plant performance.« less

49 CFR 191.13 - Distribution systems reporting transmission pipelines; transmission or gathering systems...

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 3 2010-10-01 2010-10-01 false Distribution systems reporting transmission pipelines; transmission or gathering systems reporting distribution pipelines. 191.13 Section 191.13 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF...

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

PubMed

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.

Safety Evaluation Report on Tennessee Valley Authority: Browns Ferry Nuclear Performance Plan: Browns Ferry Unit 2 restart

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

Not Available

1989-04-01

This safety evaluation report (SER) on the information submitted by the Tennessee Valley Authority (TVA) in its Nuclear Performance Plan, through Revision 2, for the Browns Ferry Nuclear Power Station and in supporting documents has been prepared by the US Nuclear Regulatory Commission staff. The plan addresses the plant-specific concerns requiring resolution before startup of Unit 2. The staff will inspect implementation of those programs. Where systems are common to Units 1 and 2 or to Units 2 and 3, the staff safety evaluations of those systems are included herein. 3 refs.

ORAM-SENTINEL{trademark} demonstration at Fitzpatrick. Final report

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

Lee, L.K.; Anderson, V.M.; Mohammadi, K.

1998-06-01

New York Power Authority, in cooperation with EPRI, installed the ORAM-SENTINEL{trademark} software at James A. Fitzpatrick (JAF) Nuclear Power Plant. This software incorporates models of safety systems and support systems that are used for defense-in-depth in the plant during outage and on-line periods. A secondary goal was to include some pre-analyzed risk results to validate the methodology for quantitative assessment of the plant risks during proposed on-line maintenance. During the past year, New York Power Authority personnel have become familiar with the formal computerized Safety Assessment process associated with on-line and outage maintenance. The report describes techniques and lessons learnedmore » during development of the ORAM-SENTINEL model at JAF. It overviews the systems important to the Safety Function Assessment Process and provides details on development of the Plant Transient Assessment process using the station emergency operating procedures. The assessment results are displayed by color (green, yellow, orange, red) to show decreasing safety conditions. The report describes use of the JAF Probabilistic Safety Assessment within the ORAM-SENTINEL code to calculate an instantaneous core damage frequency and the criteria by which this frequency is translated to a color indicator.« less

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

PubMed

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

2010-09-01

The value of near-miss and error reporting processes in many industries is well appreciated and typically can be supported with data that have been collected over time. While it is generally accepted that such processes are important in the radiation therapy (RT) setting, studies analyzing the effects of organized reporting and process improvement systems on operation and patient safety in individual clinics remain scarce. The purpose of this work is to report on the design and long-term use of an electronic reporting system in a RT department and compare it to the paper-based reporting system it replaced. A specifically designed web-based system was designed for reporting of individual events in RT and clinically implemented in 2007. An event was defined as any occurrence that could have, or had, resulted in a deviation in the delivery of patient care. The aim of the system was to support process improvement in patient care and safety. The reporting tool was designed so individual events could be quickly and easily reported without disrupting clinical work. This was very important because the system use was voluntary. The spectrum of reported deviations extended from minor workflow issues (e.g., scheduling) to errors in treatment delivery. Reports were categorized based on functional area, type, and severity of an event. The events were processed and analyzed by a formal process improvement group that used the data and the statistics collected through the web-based tool for guidance in reengineering clinical processes. The reporting trends for the first 24 months with the electronic system were compared to the events that were reported in the same clinic with a paper-based system over a seven-year period. The reporting system and the process improvement structure resulted in increased event reporting, improved event communication, and improved identification of clinical areas which needed process and safety improvements. The reported data were also useful for the evaluation of corrective measures and recognition of ineffective measures and efforts. The electronic system was relatively well accepted by personnel and resulted in minimal disruption of clinical work. Event reporting in the quarters with the fewest number of reported events, though voluntary, was almost four times greater than the most events reported in any one quarter with the paper-based system and remained consistent from the inception of the process through the date of this report. However, the acceptance was not universal, validating the need for improved education regarding reporting processes and systematic approaches to reporting culture development. Specially designed electronic event reporting systems in a radiotherapy setting can provide valuable data for process and patient safety improvement and are more effective reporting mechanisms than paper-based systems. Additional work is needed to develop methods that can more effectively utilize reported data for process improvement, including the development of standardized event taxonomy and a classification system for RT.

Integrated vehicle-based safety systems field operational test final program report.

DOT National Transportation Integrated Search

2011-06-01

"This document presents results from the light-vehicle and heavy-truck field operational tests performed as part of the Integrated Vehicle-Based Safety Systems (IVBSS) program. The findings are the result of analyses performed by the University of Mi...

Integrated Vehicle-Based Safety Systems Field Operational Test : Final Program Report

DOT National Transportation Integrated Search

2011-06-01

This document presents results from the light-vehicle and heavy-truck field operational tests performed as part of the Integrated Vehicle-Based Safety Systems (IVBSS) program. The findings are the result of analyses performed by the University of Mic...

Integrated vehicle-based safety systems : heavy-truck field operational test key findings report.

DOT National Transportation Integrated Search

2010-08-01

This document presents key findings from the heavy-truck field operational test conducted as : part of the Integrated Vehicle-Based Safety Systems program. These findings are the result of : analyses performed by the University of Michigan Transporta...

Integrated vehicle-based safety systems light-vehicle field operational test key findings report.

DOT National Transportation Integrated Search

2011-01-01

This document presents key findings from the light-vehicle field operational test conducted as part of the Integrated Vehicle-Based Safety Systems program. These findings are the result of analyses performed by the University of Michigan Transportati...

Integrated vehicle-based safety systems light-vehicle field operational test key findings report.

DOT National Transportation Integrated Search

2011-01-01

"This document presents key findings from the light-vehicle field operational test conducted as part of the Integrated Vehicle-Based Safety Systems program. These findings are the result of analyses performed by the University of Michigan Transportat...

Adverse drug events and the Freedom of Information Act: an apple in Eden.

PubMed

Stang, P E; Fox, J L

1992-02-01

To review some of the abuses and proper uses of the Food and Drug Administration's (FDA's) spontaneous adverse-reaction reporting system, as a way of educating the reader to its strengths and limitations. Published literature and reports based on information obtained from the FDA's database of spontaneous adverse drug-event reports. The Freedom of Information Act has increased public access to the FDA's database of spontaneous adverse drug reaction reports. As these reports are voluntarily received and reported to the FDA, their use for comparisons of drug safety is severely limited. Despite these limitations and the FDA's caveats for use of these data, consumer advocacy groups, researchers, and various pharmaceutical marketing groups have used this source to project the incidence of adverse drug reactions. The FDA's spontaneous adverse-event reporting system is designed to generate signals of unexpected adverse drug events. Use of the data gathered by this system to make drug safety comparisons is beyond their credible scope because many factors influence the reporting of adverse events. Researchers and peer reviewers should place these data in the proper perspective and support sound research into questions of drug safety.

Making Residents Part of the Safety Culture: Improving Error Reporting and Reducing Harms.

PubMed

Fox, Michael D; Bump, Gregory M; Butler, Gabriella A; Chen, Ling-Wan; Buchert, Andrew R

2017-01-30

Reporting medical errors is a focus of the patient safety movement. As frontline physicians, residents are optimally positioned to recognize errors and flaws in systems of care. Previous work highlights the difficulty of engaging residents in identification and/or reduction of medical errors and in integrating these trainees into their institutions' cultures of safety. The authors describe the implementation of a longitudinal, discipline-based, multifaceted curriculum to enhance the reporting of errors by pediatric residents at Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center. The key elements of this curriculum included providing the necessary education to identify medical errors with an emphasis on systems-based causes, modeling of error reporting by faculty, and integrating error reporting and discussion into the residents' daily activities. The authors tracked monthly error reporting rates by residents and other health care professionals, in addition to serious harm event rates at the institution. The interventions resulted in significant increases in error reports filed by residents, from 3.6 to 37.8 per month over 4 years (P < 0.0001). This increase in resident error reporting correlated with a decline in serious harm events, from 15.0 to 8.1 per month over 4 years (P = 0.01). Integrating patient safety into the everyday resident responsibilities encourages frequent reporting and discussion of medical errors and leads to improvements in patient care. Multiple simultaneous interventions are essential to making residents part of the safety culture of their training hospitals.

Application of an aviation model of incident reporting and investigation to the neurosurgical scenario: method and preliminary data.

PubMed

Ferroli, Paolo; Caldiroli, Dario; Acerbi, Francesco; Scholtze, Maurizio; Piro, Alfonso; Schiariti, Marco; Orena, Eleonora F; Castiglione, Melina; Broggi, Morgan; Perin, Alessandro; DiMeco, Francesco

2012-11-01

Incident reporting systems are universally recognized as important tools for quality improvement in all complex adaptive systems, including the operating room. Nevertheless, introducing a safety culture among neurosurgeons is a slow process, and few studies are available in the literature regarding the implementation of an incident reporting system within a neurosurgical department. The authors describe the institution of an aviation model of incident reporting and investigation in neurosurgery, focusing on the method they have used and presenting some preliminary results. In 2010, the Inpatient Safety On-Board project was developed through cooperation between a team of human factor and safety specialists with aviation backgrounds (DgSky team) and the general manager of the Fondazione Istituto Neurologico Carlo Besta. In 2011, after specific training in safety culture, the authors implemented an aviation-derived prototype of incident reporting within the Department of Neurosurgery. They then developed an experimental protocol to track, analyze, and categorize any near misses that happened in the operating room. This project officially started in January 2012, when a dedicated team of assessors was established. All members of the neurosurgical department were asked to report near misses on a voluntary, confidential, and protected form (Patient Incident Reporting System form, Besta Safety Management Programme). Reports were entered into an online database and analyzed by a dedicated team of assessors with the help of a facilitator, and an aviation-derived root cause analysis was performed. Since January 2012, 14 near misses were analyzed and classified. The near-miss contributing factors were mainly related to human factors (9 of 14 cases), technology (1 of 14 cases), organizational factors (3 of 14 cases), or procedural factors (1 of 14 cases). Implementing an incident reporting system is quite demanding; the process should involve all of the people who work within the environment under study. Persistence and strong commitment are required to enact the culture change essential in shifting from a paradigm of infallible operators to the philosophy of errare humanum est. For this paradigm shift to be successful, contributions from aviation and human factor experts are critical.

Post-licensure safety surveillance of 23-valent pneumococcal polysaccharide vaccine in the Vaccine Adverse Event Reporting System (VAERS), 1990-2013.

PubMed

Miller, Elaine R; Moro, Pedro L; Cano, Maria; Lewis, Paige; Bryant-Genevier, Marthe; Shimabukuro, Tom T

2016-05-27

23-Valent pneumococcal polysaccharide vaccine, trade name Pneumovax(®)23 (PPSV23), has been used for decades in the Unites States and has an extensive clinical record. However, limited post-licensure safety assessment has been conducted. To analyze reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following PPSV23 from 1990 to 2013 in order to characterize its safety profile. We searched the VAERS database for US reports following PPSV23 for persons vaccinated from 1990 to 2013. We assessed safety through: automated analysis of VAERS data, crude adverse event (AE) reporting rates based on PPSV23 doses distributed in the US market, clinical review of death reports and reports involving vaccine administered to pregnant women, and empirical Bayesian data mining to assess for disproportional reporting. During the study period, VAERS received 25,168 PPSV23 reports; 92% were non-serious, 67% were in females and 86% were in adults aged ≥19 years. When PPSV23 was administered alone, fever (43%), injection site erythema (28%) and injection site pain (25%) were the most commonly reported non-serious AEs in children. Injection site erythema (32%), injection site pain (27%) and injection site swelling (23%) were the most commonly reported non-serious AEs in adults. Of serious reports (2129, 8% of total), fever was most commonly reported in both children (69%) and adults (39%). There were 66 reports of death, four in children and 62 in adults. Clinical review of death reports did not reveal any concerning patterns that would suggest a causal association with PPSV23. No disproportional reporting of unexpected AEs was observed in empirical Bayesian data mining. We did not identify any new or unexpected safety concerns for PPSV23. The VAERS data are consistent with safety data from pre-licensure clinical trials and other post-licensure studies. Published by Elsevier Ltd.

Engineering Safety- and Security-Related Requirements for Software-Intensive Systems

DTIC Science & Technology

2010-04-27

Requirements Negative (shall not) Requirements Hardware Requirements equ remen s System / Documentation Requirements eve oper Requirements Operational ...Validation Actual / Proposed Defensibility C li Operational Vulnerability Analysis VulnerabilityVulnerability Safety Vulnerability performs System ...including suggestions for reducing this burden, to Washington Headquarters Services, Directorate for Information Operations and Reports, 1215 Jefferson

78 FR 41436 - Proposed Revision to Treatment of Non-Safety Systems for Passive Advanced Light Water Reactors

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-10

... Safety Analysis Reports for Nuclear Power Plants: LWR Edition,'' on a proposed new section to its... revised position on the treatment of the high winds external hazard for certain RTNSS structures, systems... winds external hazard for certain RTNSS structures, systems and components (SSCs). This position differs...

Crash Outcome Data Evaluation System (CODES) Project Safety Belt and Helmet Analyses

DOT National Transportation Integrated Search

1996-02-15

Analyses of the benefits of safety belt and helmet use were undertaken for a : Report that was sent to Congress February, 1996. NHTSA awarded grants to link : crash and injury state data and perform the analyses upon which the report was : based. The...

Vaccinovigilance in Europe--need for timeliness, standardization and resources.

PubMed Central

Lankinen, Kari S.; Pastila, Satu; Kilpi, Terhi; Nohynek, Hanna; Mäkelä, P. Helena; Olin, Patrick

2004-01-01

OBJECTIVE: To identify gaps in the systems for reporting adverse events following immunization (AEFI) in Europe by means of an interactive database constructed using a standardized approach. METHODS: A comparative survey was conducted in 1999-2000, using structured questionnaires addressed to the government authorities responsible for national immunization programmes and drug safety surveillance in all European Union (EU) Member States and in Norway and Switzerland. FINDINGS: The reporting of adverse vaccine reactions (AVRs) is covered by regulations in 13 of the 17 countries. Four countries have a specialized expert group with responsibility for vaccine safety. Only six professionals work full-time on vaccine safety in the 17 countries; in four of these countries the person is medically qualified. Fourteen countries have centralized reporting systems; in 14 countries the responsible authority is the drug regulatory agency. AEFI are reported using the procedure used for adverse drug reactions (ADRs) in all except four countries. The reporting form is not usually designed for vaccines and important details may therefore not be requested. Clinical definitions for vaccine reactions are not available. Twelve countries have appropriate official definitions for events or reactions, but the list of reportable events varies considerably between countries. The assessment of adverse vaccine reactions (AVRs) is hampered by lack of exact denominator data. Feedback to the rapporteurs was provided in 13 countries, but its quality was highly variable. CONCLUSION: The database facilitated a simple comparison of vaccinovigilance systems across participating countries. Most of the problems identified related to the reporting and analysis of AEFI could be solved through standardization and intensified international collaboration. On a national level, functional vaccinovigilance systems should be the shared responsibility of the drug regulatory authority and the national immunization programme. The resources for development and management of vaccine safety systems should be urgently improved. PMID:15640918

Analytical methodology for safety validation of computer controlled subsystems. Volume 1 : state-of-the-art and assessment of safety verification/validation methodologies

DOT National Transportation Integrated Search

1995-09-01

This report describes the development of a methodology designed to assure that a sufficiently high level of safety is achieved and maintained in computer-based systems which perform safety critical functions in high-speed rail or magnetic levitation ...

Student manual, Book 2: Orientation to occupational safety compliance in DOE

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

Colley, D.L.

1993-10-01

This is a student hand-book an Occupational Safety Compliance in DOE. Topics include the following: Electrical; materials handling & storage; inspection responsibilities & procedures; general environmental controls; confined space entry; lockout/tagout; office safety, ergonomics & human factors; medical & first aid, access to records; construction safety; injury/illness reporting system; and accident investigation procedures.

[Medication error management climate and perception for system use according to construction of medication error prevention system].

PubMed

Kim, Myoung Soo

2012-08-01

The purpose of this cross-sectional study was to examine current status of IT-based medication error prevention system construction and the relationships among system construction, medication error management climate and perception for system use. The participants were 124 patient safety chief managers working for 124 hospitals with over 300 beds in Korea. The characteristics of the participants, construction status and perception of systems (electric pharmacopoeia, electric drug dosage calculation system, computer-based patient safety reporting and bar-code system) and medication error management climate were measured in this study. The data were collected between June and August 2011. Descriptive statistics, partial Pearson correlation and MANCOVA were used for data analysis. Electric pharmacopoeia were constructed in 67.7% of participating hospitals, computer-based patient safety reporting systems were constructed in 50.8%, electric drug dosage calculation systems were in use in 32.3%. Bar-code systems showed up the lowest construction rate at 16.1% of Korean hospitals. Higher rates of construction of IT-based medication error prevention systems resulted in greater safety and a more positive error management climate prevailed. The supportive strategies for improving perception for use of IT-based systems would add to system construction, and positive error management climate would be more easily promoted.

2006 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

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

2007-01-01

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

Adverse Events to Food Supplements Containing Red Yeast Rice: Comparative Analysis of FAERS and CAERS Reporting Systems.

PubMed

Raschi, Emanuel; Girardi, Anna; Poluzzi, Elisabetta; Forcesi, Emanuele; Menniti-Ippolito, Francesca; Mazzanti, Gabriela; De Ponti, Fabrizio

2018-03-26

Food supplements containing red yeast rice (RYR) are proposed as an alternative in statin-intolerant patients, although they actually contain natural statin(s) and their safety in clinical practice is still incompletely characterized. We described and compared adverse events (AEs) associated with RYR products submitted to reporting systems maintained by the Food and Drug Administration (FDA), with a focus on liver and muscular events. We extracted RYR-related AEs from the FDA Adverse Event Reporting System (FAERS) [first quarter (Q1)-2004 to Q2-2016], a drug-based archive, and the Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS) (Q1-2004 to Q1-2017). Disproportionality via reporting odds ratio (ROR) with 95% confidence interval (CI) calculation and case-by-case inspection were performed, with a focus on muscular and hepatic AEs. One thousand three hundred AEs were extracted from FAERS (RYR mainly reported as a concomitant agent), whereas only 159 AEs were found in CAERS (RYR recorded mainly as a suspect agent). In FAERS, a large number of reports emerged for "general disorders and administration site conditions," whereas CAERS received also a high number of reports for "investigations" and "musculoskeletal and connective tissue disorders". Disproportionality analyses confirmed higher reporting of serious muscular and liver injuries: in FAERS, five cases of hepatic disorders (ROR = 13.71; 95% CI 5.44-34.57); in CAERS, 27 cases of rhabdomyolysis/myopathy (8.44; 5.44-13.10). Notwithstanding recognized limitations, these findings strengthen the importance of exploring multiple databases in safety assessment of RYR products, which should be monitored by clinicians for muscular and hepatic safety, and call for urgent review by policymakers to harmonize their regulatory status.

Patient safety: lessons learned.

PubMed

Bagian, James P

2006-04-01

The traditional approach to patient safety in health care has ranged from reticence to outward denial of serious flaws. This undermines the otherwise remarkable advances in technology and information that have characterized the specialty of medical practice. In addition, lessons learned in industries outside health care, such as in aviation, provide opportunities for improvements that successfully reduce mishaps and errors while maintaining a standard of excellence. This is precisely the call in medicine prompted by the 1999 Institute of Medicine report "To Err Is Human: Building a Safer Health System." However, to effect these changes, key components of a successful safety system must include: (1) communication, (2) a shift from a posture of reliance on human infallibility (hence "shame and blame") to checklists that recognize the contribution of the system and account for human limitations, and (3) a cultivation of non-punitive open and/or de-identified/anonymous reporting of safety concerns, including close calls, in addition to adverse events.

Patient safety incident reporting: a qualitative study of thoughts and perceptions of experts 15 years after 'To Err is Human'.

PubMed

Mitchell, Imogen; Schuster, Anne; Smith, Katherine; Pronovost, Peter; Wu, Albert

2016-02-01

One of the key recommendations of the Institute of Medicine's (IOM) report, To Err is Human, 15 years ago was for greater attention to incident reporting in healthcare, analogous to the role it has played in aviation and other high-risk industries. With the passage of time and maturation of the patient safety field, we conducted semistructured interviews with 11 international patient safety experts with knowledge of the US healthcare and meeting at least one of the following criteria: (1) involved in the development of the IOM's recommendations, (2) responsible for the design and/or implementation of national or regional incident reporting systems, (3) conducted research on patient safety/incident reporting at a national level. Five key challenges emerged to explain why incident reporting has not reached its potential: poor processing of incident reports (triaging, analysis, recommendations), inadequate engagement of doctors, insufficient subsequent visible action, inadequate funding and institutional support of incident reporting systems and inadequate usage of evolving health information technology. Leading patient safety experts acknowledge the current challenges of incident reports. The future of incident reporting lies in targeted incident reporting, effective triaging and robust analysis of the incident reports and meaningful engagement of doctors. Incident reporting must be coupled with visible, sustainable action and linkage of incident reports to the electronic health record. If the healthcare industry wants to learn from its mistakes, miss or near miss events, it will need to take incident reporting as seriously as the health budget. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Integrated vehicle-based safety systems heavy truck field operational test, methodology and results report.

DOT National Transportation Integrated Search

2010-12-01

"This document presents the methodology and results from the heavy-truck field operational test conducted as part of the Integrated Vehicle-Based Safety Systems program. These findings are the result of analyses performed by the University of Michiga...

Integrated vehicle-based safety systems light-vehicle field operational test, methodology and results report.

DOT National Transportation Integrated Search

2010-12-01

"This document presents the methodology and results from the light-vehicle field operational test conducted as part of the Integrated Vehicle-Based Safety Systems program. These findings are the result of analyses performed by the University of Michi...

[Implementation of a safety and health planning system in a teaching hospital].

PubMed

Mariani, F; Bravi, C; Dolcetti, L; Moretto, A; Palermo, A; Ronchin, M; Tonelli, F; Carrer, P

2007-01-01

University Hospital "L. Sacco" had started in 2006 a two-year project in order to set up a "Health and Safety Management System (HSMS)" referring to the technical guideline OHSAS 18001:1999 and the UNI and INAIL "Guidelines for a health and safety management system at workplace". So far, the following operations had been implemented: Setting up of a specific Commission within the Risk Management Committee; Identification and appointment of Departmental Representatives of HSMS; Carrying out of a training course addressed to Workers Representatives for Safety and Departmental Representatives of HSMS; Development of an Integrated Informative System for Prevention and Safety; Auditors qualification; Inspection of the Occupational Health Unit and the Prevention and Safety Service: reporting of critical situations and monitoring solutions adopted. Short term objectives are: Self-evaluation through check-lists of each department; Sharing of the Improvement Plan among the departments of the hospital; Planning of Health and Safety training activities in the framework of the Hospital Training Plan; Safety audit.

Safety analysis report for packaging, onsite, long-length contaminated equipment transport system

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

McCormick, W.A.

1997-05-09

This safety analysis report for packaging describes the components of the long-length contaminated equipment (LLCE) transport system (TS) and provides the analyses, evaluations, and associated operational controls necessary for the safe use of the LLCE TS on the Hanford Site. The LLCE TS will provide a standardized, comprehensive approach for the disposal of approximately 98% of LLCE scheduled to be removed from the 200 Area waste tanks.

Safety Management Information Statistics (SAMIS) - 1992 Annual Report

DOT National Transportation Integrated Search

1994-06-01

This SAMIS 1992 annual report, now in its third year of publication, is a compilation and analysis of mass transit accident and casualty statistics reported by 600 transit systems in the United States under the FTA Section 15 reporting system. This r...

Consumer reporting of adverse events following immunization.

PubMed

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 (P<0.001), most commonly for children aged less than 7 years. Consumer reports were 5% more likely to describe serious AEFI than HCP (P=0.018) and 10% more likely to result in specialist clinic attendance (P<0.001). Although online reporting 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.

Developing and deploying a patient safety program in a large health care delivery system: you can't fix what you don't know about.

PubMed

Bagian, J P; Lee, C; Gosbee, J; DeRosier, J; Stalhandske, E; Eldridge, N; Williams, R; Burkhardt, M

2001-10-01

The Veterans Administration (VA) identified patient safety as a high-priority issue in 1997 and implemented the Patient Safety Improvement (PSI) initiative throughout its entire health care system. In spring 1998 the External Panel on Patient Safety System Design recommended alternative methods to enhance reporting and thereby improve patient safety. REDESIGNING THE PSI INITIATIVE: The VA began redesigning the PSI initiative in late 1998. The dedicated National Center for Patient Safety (NCPS) was established. Using the panel's recommendations as a jumping-off point, NCPS began to identify known and suspected obstacles to implementation (such as possible punitive consequences and additional workload). NCPS adopted a prioritization scoring method, the Safety Assessment Code (SAC) Matrix, for close calls and adverse events, which requires assessing the event's actual or potential severity and the probability of occurrence. The SAC Matrix specifies actions that must be taken for given scores. Use of the SAC score permits a consistent handling of reports throughout the VA system and a rational selection of cases to be considered. A system for performing a root cause analysis (RCA) was developed to guide caregivers at the frontline. This system includes a computer-aided tool, a flipbook containing a series of six questions, and reporting of the findings back to the reporter. The final step requires that the facility's chief executive officer "concur" or "nonconcur" on each recommended corrective action. The RCA team outlines how the effectiveness of the corrective action will be evaluated to verify that the action has had the intended effect, and it ascertains that there were no unintended negative consequences. Based on successful implementation in two pilots, full-scale national rollout to the 173 facilities began in April 2000 and was concluded by the end of August 2000. NCPS supplied 3 days of training for individuals at each facility. The training included didactic components, an introduction to human factors engineering concepts, and small- and large-group simulation exercises. Facility leaders were reminded of the necessity to reinforce the point that assignment to an RCA team was considered an important duty. It is essential to design and implement a system that takes into account the concerns of the frontline personnel and is aimed at being a tool for learning and not accountability. The system must have as its primary focus the dissemination of positive actions that reduce or eliminate vulnerabilities that have been identified, not a counting exercise of the number of reports.

Display system replacement baseline research report.

DOT National Transportation Integrated Search

2000-12-01

This report provides baseline measurements on the Display System Replacement (DSR). These measurements followed six constructs: : safety, capacity, performance, workload, usability, and simulation fidelity. To collect these measurements, human factor...

The orthopaedic error index: development and application of a novel national indicator for assessing the relative safety of hospital care using a cross-sectional approach.

PubMed

Panesar, Sukhmeet S; Netuveli, Gopalakrishnan; Carson-Stevens, Andrew; Javad, Sundas; Patel, Bhavesh; Parry, Gareth; Donaldson, Liam J; Sheikh, Aziz

2013-11-21

The Orthopaedic Error Index for hospitals aims to provide the first national assessment of the relative safety of provision of orthopaedic surgery. Cross-sectional study (retrospective analysis of records in a database). The National Reporting and Learning System is the largest national repository of patient-safety incidents in the world with over eight million error reports. It offers a unique opportunity to develop novel approaches to enhancing patient safety, including investigating the relative safety of different healthcare providers and specialties. We extracted all orthopaedic error reports from the system over 1 year (2009-2010). The Orthopaedic Error Index was calculated as a sum of the error propensity and severity. All relevant hospitals offering orthopaedic surgery in England were then ranked by this metric to identify possible outliers that warrant further attention. 155 hospitals reported 48 971 orthopaedic-related patient-safety incidents. The mean Orthopaedic Error Index was 7.09/year (SD 2.72); five hospitals were identified as outliers. Three of these units were specialist tertiary hospitals carrying out complex surgery; the remaining two outlier hospitals had unusually high Orthopaedic Error Indexes: mean 14.46 (SD 0.29) and 15.29 (SD 0.51), respectively. The Orthopaedic Error Index has enabled identification of hospitals that may be putting patients at disproportionate risk of orthopaedic-related iatrogenic harm and which therefore warrant further investigation. It provides the prototype of a summary index of harm to enable surveillance of unsafe care over time across institutions. Further validation and scrutiny of the method will be required to assess its potential to be extended to other hospital specialties in the UK and also internationally to other health systems that have comparable national databases of patient-safety incidents.

Reliability Modeling Methodology for Independent Approaches on Parallel Runways Safety Analysis

NASA Technical Reports Server (NTRS)

Babcock, P.; Schor, A.; Rosch, G.

1998-01-01

This document is an adjunct to the final report An Integrated Safety Analysis Methodology for Emerging Air Transport Technologies. That report presents the results of our analysis of the problem of simultaneous but independent, approaches of two aircraft on parallel runways (independent approaches on parallel runways, or IAPR). This introductory chapter presents a brief overview and perspective of approaches and methodologies for performing safety analyses for complex systems. Ensuing chapter provide the technical details that underlie the approach that we have taken in performing the safety analysis for the IAPR concept.

75 FR 23271 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-03

... proposed information collection project: ``National Hospital Adverse Event Reporting System: Questionnaire...: Proposed Project National Hospital Adverse Event Reporting System: Questionnaire Redesign and Testing As... the impact of the PSOs and the Patient Safety Act on the use of adverse event reporting systems and...

75 FR 38102 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-01

... proposed information collection project: ``National Hospital Adverse Event Reporting System: Questionnaire...: Proposed Project National Hospital Adverse Event Reporting System: Questionnaire Redesign and Testing As... the impact of the PSOs and the Patient Safety Act on the use of adverse event reporting systems and...

A Real-Time Safety and Quality Reporting System: Assessment of Clinical Data and Staff Participation

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

Rahn, Douglas A.; Kim, Gwe-Ya; Mundt, Arno J.

Purpose: To report on the use of an incident learning system in a radiation oncology clinic, along with a review of staff participation. Methods and Materials: On September 24, 2010, our department initiated an online real-time voluntary reporting system for safety issues, called the Radiation Oncology Quality Reporting System (ROQRS). We reviewed these reports from the program's inception through January 18, 2013 (2 years, 3 months, 25 days) to assess error reports (defined as both near-misses and incidents of inaccurate treatment). Results: During the study interval, there were 60,168 fractions of external beam radiation therapy and 955 brachytherapy procedures. There were 298 entriesmore » in the ROQRS system, among which 108 errors were reported. There were 31 patients with near-misses reported and 27 patients with incidents of inaccurate treatment reported. These incidents of inaccurate treatment occurred in 68 total treatment fractions (0.11% of treatments delivered during the study interval). None of these incidents of inaccurate treatment resulted in deviation from the prescription by 5% or more. A solution to the errors was documented in ROQRS in 65% of the cases. Errors occurred as repeated errors in 22% of the cases. A disproportionate number of the incidents of inaccurate treatment were due to improper patient setup at the linear accelerator (P<.001). Physician participation in ROQRS was nonexistent initially, but improved after an education program. Conclusions: Incident learning systems are a useful and practical means of improving safety and quality in patient care.« less

Vaccine safety monitoring systems in developing countries: an example of the Vietnam model.

PubMed

Ali, Mohammad; Rath, Barbara; Thiem, Vu Dinh

2015-01-01

Only few health intervention programs have been as successful as vaccination programs with respect to preventing morbidity and mortality in developing countries. However, the success of a vaccination program is threatened by rumors and misunderstanding about the risks of vaccines. It is short-sighted to plan the introduction of vaccines into developing countries unless effective vaccine safety monitoring systems are in place. Such systems that track adverse events following immunization (AEFI) is currently lacking in most developing countries. Therefore, any rumor may affect the entire vaccination program. Public health authorities should implement the safety monitoring system of vaccines, and disseminate safety issues in a proactive mode. Effective safety surveillance systems should allow for the conduct of both traditional and alternative epidemiologic studies through the use of prospective data sets. The vaccine safety data link implemented in Vietnam in mid-2002 indicates that it is feasible to establish a vaccine safety monitoring system for the communication of vaccine safety in developing countries. The data link provided the investigators an opportunity to evaluate AEFI related to measles vaccine. Implementing such vaccine safety monitoring system is useful in all developing countries. The system should be able to make objective and clear communication regarding safety issues of vaccines, and the data should be reported to the public on a regular basis for maintaining their confidence in vaccination programs.

A Multilevel Analysis of U.S. Hospital Patient Safety Culture Relationships With Perceptions of Voluntary Event Reporting.

PubMed

Burlison, Jonathan D; Quillivan, Rebecca R; Kath, Lisa M; Zhou, Yinmei; Courtney, Sam C; Cheng, Cheng; Hoffman, James M

2016-11-03

Patient safety events offer opportunities to improve patient care, but, unfortunately, events often go unreported. Although some barriers to event reporting can be reduced with electronic reporting systems, insight on organizational and cultural factors that influence reporting frequency may help hospitals increase reporting rates and improve patient safety. The purpose of this study was to evaluate the associations between dimensions of patient safety culture and perceived reporting practices of safety events of varying severity. We conducted a cross-sectional survey study using previously collected data from The Agency for Healthcare Research and Quality Hospital Survey of Patient Safety Culture as predictors and outcome variables. The dataset included health-care professionals in U.S. hospitals, and data were analyzed using multilevel modeling techniques. Data from 223,412 individuals, 7816 work areas/units, and 967 hospitals were analyzed. Whether examining near miss, no harm, or potential for harm safety events, the dimension feedback about error accounted for the most unique predictive variance in the outcome frequency of events reported. Other significantly associated variables included organizational learning, nonpunitive response to error, and teamwork within units (all P < 0.001). As the perceived severity of the safety event increased, more culture dimensions became significantly associated with voluntary reporting. To increase the likelihood that a patient safety event will be voluntarily reported, our study suggests placing priority on improving event feedback mechanisms and communication of event-related improvements. Focusing efforts on these aspects may be more efficient than other forms of culture change.

A Multilevel Analysis of U.S. Hospital Patient Safety Culture Relationships with Perceptions of Voluntary Event Reporting

PubMed Central

Burlison, Jonathan D.; Quillivan, Rebecca R.; Kath, Lisa M.; Zhou, Yinmei; Courtney, Sam C.; Cheng, Cheng; Hoffman, James M.

2016-01-01

Objectives Patient safety events offer opportunities to improve patient care, but, unfortunately, events often go unreported. Although some barriers to event reporting can be reduced with electronic reporting systems, insight on organizational and cultural factors that influence reporting frequency may help hospitals increase reporting rates and improve patient safety. The purpose of this study was to evaluate the associations between dimensions of patient safety culture and perceived reporting practices of safety events of varying severity. Methods We conducted a cross-sectional survey study using previously collected data from The Agency for Healthcare Research and Quality Hospital Survey of Patient Safety Culture as predictors and outcome variables. The dataset included healthcare professionals in U.S. hospitals, and data were analyzed by using multilevel modeling techniques. Results Data from 223,412 individuals, 7816 work areas/units and 967 hospitals were analyzed. Whether examining Near-miss, No harm, or Potential for harm safety events, the dimension Feedback about error accounted for the most unique predictive variance in the outcome Frequency of events reported. Other significantly associated variables included Organizational learning, Nonpunitive response to error, and Teamwork within units (all p<.001). As the perceived severity of the safety event increased, more culture dimensions became significantly associated with voluntary reporting. Conclusions To increase the likelihood that a patient safety event will be voluntarily reported, our study suggests placing priority on improving event feedback mechanisms and communication of event-related improvements. Focusing efforts on these aspects may be more efficient than other forms of culture change. PMID:27820722

Adverse events following immunisation with a meningococcal serogroup B vaccine: report from post-marketing surveillance, Germany, 2013 to 2016.

PubMed

Mentzer, Dirk; Oberle, Doris; Keller-Stanislawski, Brigitte

2018-04-01

Background and aimIn January 2013, a novel vaccine against Neisseria meningitidis serogroup B, the multicomponent meningococcal serogroup B vaccine (4CMenB), was approved by the European Medicines Agency. We aimed to evaluate the safety profile of this vaccine. Methods: All adverse events following immunisation (AEFI) reported from Germany since the vaccine's launch in Germany in November 2013 through December 2016 were reviewed and analysed. Results: Through December 2016, a total of 664 individual case safety reports (ICSR) notifying 1,960 AEFI were received. A majority of vaccinees for whom AEFI were reported were children 2 to 11 years of age (n = 280; 42.2%) followed by infants and toddlers aged 28 days to 23 months (n = 170; 25.6%). General disorders and administration site conditions was the System Organ Class (SOC) with the majority of AEFI (n = 977; 49.8%), followed by nervous system disorders (n = 249; 12.7%), and skin and subcutaneous tissue disorders (n = 191; 9.7%). Screening of patient records for immune-mediated and neurological diseases did not raise any safety signal in terms of an increased proportional reporting ratio (PRR). Conclusions: The safety profile described in the Summary of Product Characteristics, in general, is confirmed by data from spontaneous reporting. No safety concerns were identified.

University Safety Culture: A Work-in-Progress?

ERIC Educational Resources Information Center

Lyons, Michael

2016-01-01

Safety management systems in Australian higher education organisations are under-researched. Limited workplace safety information can be found in the various reports on university human resources benchmarking programs, and typically they show only descriptive statistics. With the commencement of new consultation-focused regulations applying to…

Evaluation of a variable speed limit system for wet and extreme weather conditions : phase 1 report.

DOT National Transportation Integrated Search

2012-06-01

Weather presents considerable challenges to the highway system, both in terms of safety and operations. From a safety standpoint, weather (i.e. precipitation in the form of rain, snow or ice) reduces pavement friction, thus increasing the potential f...

Development of crash imminent test scenarios for Integrated Vehicle-Based Safety Systems

DOT National Transportation Integrated Search

2007-04-01

This report identifies crash imminent test scenarios based on common pre-crash scenarios for integrated vehicle-based safety systems that alert the driver of a light vehicle or a heavy truck to an impending rear-end, lane change, or run-off-road cras...

Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006-2015.

PubMed

Miller, Elaine R; Lewis, Paige; Shimabukuro, Tom T; Su, John; Moro, Pedro; Woo, Emily Jane; Jankosky, Christopher; Cano, Maria

2018-03-26

Herpes zoster (HZ), or shingles, is caused by reactivation of varicella-zoster virus in latently infected individuals. Live-attenuated HZ vaccine (zoster vaccine live, ZVL) is approved in the United States for persons aged ≥50 years and recommended by the CDC for persons ≥60 years. We analyzed U.S. reports of adverse events (AEs) following ZVL submitted to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system to monitor vaccine safety, for persons vaccinated May 1, 2006, through January 31, 2015. We conducted descriptive analysis, clinical reviews of reports with selected pre-specified conditions, and empirical Bayesian data mining. VAERS received 23,092 reports following ZVL, of which 22,120 (96%) were classified as non-serious. Of reports where age was documented (n = 18,817), 83% were in persons aged ≥60 years. Reporting rates of AEs were 106 and 4.4 per 100,000 ZVL doses distributed for all reports and serious reports, respectively. When ZVL was administered alone among persons aged ≥50 years, injection site erythema (27%), HZ (17%), injection site swelling (17%), and rash (14%) were the most commonly reported symptoms among non-serious reports; HZ (29%), pain (18%), and rash (16%) were the most commonly reported symptoms among serious reports. Six reports included laboratory evidence of vaccine-strain varicella-zoster virus (Oka/Merck strain) infection; AEs included HZ, HZ- or varicella-like illness, and local reaction with vesicles. In our review of reports of death with sufficient information to determine cause (n = 46, median age 75 years), the most common causes were heart disease (n = 28), sepsis (n = 4), and stroke (n = 3). Empirical Bayesian data mining did not detect new or unexpected safety signals. Findings from our safety review of ZVL are consistent with those from pre-licensure clinical trials and other post-licensure assessments. Transient injection-site reactions, HZ, and rashes were most frequently reported to VAERS following ZVL. Overall, our results are reassuring regarding the safety of ZVL.

33 CFR 96.250 - What documents and reports must a safety management system have?

Code of Federal Regulations, 2013 CFR

2013-07-01

... about safety and environmental pollution; and(2) Ability to request the company's help when necessary... requirements (a) Safety and environmental policy statements (1) Meet the objectives of § 96.230; and(2) Are... and affecting the safety and pollution prevention operations of the company and vessel(s); and (4) A...

33 CFR 96.250 - What documents and reports must a safety management system have?

Code of Federal Regulations, 2014 CFR

2014-07-01

... about safety and environmental pollution; and(2) Ability to request the company's help when necessary... requirements (a) Safety and environmental policy statements (1) Meet the objectives of § 96.230; and(2) Are... and affecting the safety and pollution prevention operations of the company and vessel(s); and (4) A...

33 CFR 96.250 - What documents and reports must a safety management system have?

Code of Federal Regulations, 2011 CFR

2011-07-01

... about safety and environmental pollution; and(2) Ability to request the company's help when necessary... requirements (a) Safety and environmental policy statements (1) Meet the objectives of § 96.230; and(2) Are... and affecting the safety and pollution prevention operations of the company and vessel(s); and (4) A...

33 CFR 96.250 - What documents and reports must a safety management system have?

Code of Federal Regulations, 2012 CFR

2012-07-01

... about safety and environmental pollution; and(2) Ability to request the company's help when necessary... requirements (a) Safety and environmental policy statements (1) Meet the objectives of § 96.230; and(2) Are... and affecting the safety and pollution prevention operations of the company and vessel(s); and (4) A...

Vaccine Safety

MedlinePlus

... Search Form Controls Cancel Submit Search The CDC Vaccine Safety Note: Javascript is disabled or is not ... CDC.gov . Recommend on Facebook Tweet Share Compartir Vaccine Adverse Events Reporting System (VAERS) New website and ...

A signal detection method for temporal variation of adverse effect with vaccine adverse event reporting system data.

PubMed

Cai, Yi; Du, Jingcheng; Huang, Jing; Ellenberg, Susan S; Hennessy, Sean; Tao, Cui; Chen, Yong

2017-07-05

To identify safety signals by manual review of individual report in large surveillance databases is time consuming; such an approach is very unlikely to reveal complex relationships between medications and adverse events. Since the late 1990s, efforts have been made to develop data mining tools to systematically and automatically search for safety signals in surveillance databases. Influenza vaccines present special challenges to safety surveillance because the vaccine changes every year in response to the influenza strains predicted to be prevalent that year. Therefore, it may be expected that reporting rates of adverse events following flu vaccines (number of reports for a specific vaccine-event combination/number of reports for all vaccine-event combinations) may vary substantially across reporting years. Current surveillance methods seldom consider these variations in signal detection, and reports from different years are typically collapsed together to conduct safety analyses. However, merging reports from different years ignores the potential heterogeneity of reporting rates across years and may miss important safety signals. Reports of adverse events between years 1990 to 2013 were extracted from the Vaccine Adverse Event Reporting System (VAERS) database and formatted into a three-dimensional data array with types of vaccine, groups of adverse events and reporting time as the three dimensions. We propose a random effects model to test the heterogeneity of reporting rates for a given vaccine-event combination across reporting years. The proposed method provides a rigorous statistical procedure to detect differences of reporting rates among years. We also introduce a new visualization tool to summarize the result of the proposed method when applied to multiple vaccine-adverse event combinations. We applied the proposed method to detect safety signals of FLU3, an influenza vaccine containing three flu strains, in the VAERS database. We showed that it had high statistical power to detect the variation in reporting rates across years. The identified vaccine-event combinations with significant different reporting rates over years suggested potential safety issues due to changes in vaccines which require further investigation. We developed a statistical model to detect safety signals arising from heterogeneity of reporting rates of a given vaccine-event combinations across reporting years. This method detects variation in reporting rates over years with high power. The temporal trend of reporting rate across years may reveal the impact of vaccine update on occurrence of adverse events and provide evidence for further investigations.

A first step toward understanding patient safety

PubMed Central

2016-01-01

Patient safety has become an important policy agenda in healthcare systems since publication of the 1999 report entitled "To Err Is Human." The paradigm has changed from blaming the individual for the error to identifying the weakness in the system that led to the adverse events. Anesthesia is one of the first healthcare specialties to adopt techniques and lessons from the aviation industry. The widespread use of simulation programs and the application of human factors engineering to clinical practice are the influences of the aviation industry. Despite holding relatively advanced medical technology and comparable safety records, the Korean health industry has little understanding of the systems approach to patient safety. Because implementation of the existing system and program requires time, dedication, and financial support, the Korean healthcare industry is in urgent need of developing patient safety policies and putting them into practice to improve patient safety before it is too late. PMID:27703622

SU-E-T-201: Safety-Focused Customization of Treatment Plan Documentation.

PubMed

Schubert, L; Westerly, D; Stuhr, K; Miften, M

2012-06-01

Plan report documentation contains numerous details about the treatment plan, but critical information for patient safety is often presented without special emphasis. This can make it difficult to detect errors from treatment planning and data transfer during the initial chart review. The objective of this work is to improve safety measures in radiation therapy practice by customizing the treatment plan report to emphasize safety-critical information. Commands within the template file from a commercial planning system (Eclipse, Varian Medical Systems) that automatically generates the treatment plan report were reviewed and modified. Safety-critical plan parameters were identified from published risks known to be inherent in the treatment planning process. Risks having medium to high potential impact on patient safety included incorrect patient identifiers, erroneous use of the treatment prescription, and incorrect transfer of beam parameters or consideration of accessories. Specific examples of critical information in the treatment plan report that can be overlooked during a chart review included prescribed dose per fraction and number of fractions, wedge and open field monitor units, presence of beam accessories, and table shifts for patient setup. Critical information was streamlined and concentrated. Patient and plan identification, dose prescription details, and patient positioning couch shift instructions were placed on the first page. Plan information to verify the correct data transfer to the record and verify system was re-organized in an easy to review tabular format and placed in the second page of the customized printout. Placeholders were introduced to indicate both the presence and absence of beam modifiers. Font sizes and spacing were adjusted for clarity, and departmental standards and terminology were introduced to streamline data communication among staff members. Plan reporting documentation has been customized to concentrate and emphasize safety-critical information, which should allow for a more efficient, robust chart review process. © 2012 American Association of Physicists in Medicine.

Comparison of the Safety of Seven Iodinated Contrast Media

PubMed Central

Seong, Jong-Mi; Choi, Nam-Kyong; Lee, Joongyub; Chang, Yoosoo; Kim, Ye-Jee; Yang, Bo Ram; Jin, Xue-Mei; Kim, Ju-Young

2013-01-01

We aimed to determine the characteristic adverse events (AEs) of iodinated contrast media (IOCM) and to compare the safety profiles of different IOCM. This study used the database of AEs reports submitted by healthcare professionals from 15 Regional Pharmacovigilance Centers between June 24, 2009 and December 31, 2010 in Korea. All reports of IOCM, including iopromide, iohexol, iopamidol, iomeprol, ioversol, iobitridol and iodixanol, were analyzed. Safety profiles were compared between different IOCM at the system organ level using the proportional reporting ratio (PRR) and 95% confidence interval (95% CI). Among a total of 48,261 reports, 6,524 (13.5%) reports were related to the use of IOCM. Iopromide (45.5%), iohexol (16.9%), iopamidol (14.3%) and iomeprol (10.3%) were identified as frequently reported media. 'Platelet, bleeding & clotting disorders' (PRR, 29.6; 95%CI, 1.9-472.6) and 'urinary system disorders' (PRR, 22.3; 95% CI, 17.1-29.1) were more frequently reported for iodixanol than the other IOCM. In conclusion, the frequency of AEs by organ class was significantly different between individual media. These differences among different IOCM should be considered when selecting a medium among various IOCM and when monitoring patients during and after its use to ensure optimum usage and patient safety. PMID:24339697

Identification of Vehicle Health Assurance Related Trends

NASA Technical Reports Server (NTRS)

Phojanamongkolkij, Nipa; Evans, Joni K.; Barr, Lawrence C.; Leone, Karen M.; Reveley, Mary S.

2014-01-01

Trend analysis in aviation as related to vehicle health management (VHM) was performed by reviewing the most current statistical and prognostics data available from the National Transportation Safety Board (NTSB) accident, the Federal Aviation Administration (FAA) incident, and the NASA Aviation Safety Reporting System (ASRS) incident datasets. In addition, future directions in aviation technology related to VHM research areas were assessed through the Commercial Aviation Safety Team (CAST) Safety Enhancements Reserved for Future Implementations (SERFIs), the National Transportation Safety Board (NTSB) Most-Wanted List and recent open safety recommendations, the National Research Council (NRC) Decadal Survey of Civil Aeronautics, and the Future Aviation Safety Team (FAST) areas of change. Future research direction in the VHM research areas is evidently strong as seen from recent research solicitations from the Naval Air Systems Command (NAVAIR), and VHM-related technologies actively being developed by aviation industry leaders, including GE, Boeing, Airbus, and UTC Aerospace Systems. Given the highly complex VHM systems, modifications can be made in the future so that the Vehicle Systems Safety Technology Project (VSST) technical challenges address inadequate maintenance crew's trainings and skills, and the certification methods of such systems as recommended by the NTSB, NRC, and FAST areas of change.

Development of an effective risk management system in a teaching hospital.

PubMed

Adibi, Hossein; Khalesi, Nader; Ravaghi, Hamid; Jafari, Mahdi; Jeddian, Ali Reza

2012-09-21

Unsafe health care provision is a main cause of increased mortality rate amongst hospitalized patients all over the world. A system approach to medical error and its reduction is crucial that is defined by clinical and administrative activities undertaken to identify, evaluate, and reduce the risk of injury. The aim of this study was to develop and implement a risk management system in a large teaching hospital in Iran, especially of the basis of WHO guidelines and patient safety context. WHO draft guideline and patient safety reports from different countries were reviewed for defining acceptable framework of risk management system. Also current situation of mentioned hospital in safety matter and dimensions of patient safety culture was evaluated using HSOPSC questionnaire of AHRQ. With adjustment of guidelines and hospital status, the conceptual framework was developed and next it was validated in expert panel. The members of expert panel were selected according to their role and functions and also their experiences in risk management and patient safety issues. The validated framework consisted of designating a leader and coordinator core, defining communications, and preparing the infrastructure for patient safety education and culture-building. That was developed on the basis of some values and commitments and included reactive and proactive approaches. The findings of reporting activities demonstrated that at least 3.6 percent of hospitalized patients have experienced adverse events and 5.3 percent of all deaths in the hospital related with patient safety problems. Beside the average score of 12 dimensions of patient safety culture was 46.2 percent that was considerably low. The "non-punitive responses to error" had lowest positive score with 21.2 percent. It is of paramount importance for all health organizations to lay necessary foundations in order to identify safety risks and improve the quality of care. Inadequate participation of staff in education, reporting and analyzing, underreporting and uselessness of aggregated data, limitation of human and financial resources, punitive directions and management challenges for solutions were the main executive problems which could affect the effectiveness of system.

Impact of reconstruction strategies on system performance measures : maximizing safety and mobility while minimizing life-cycle costs : final report, December 8, 2008.

DOT National Transportation Integrated Search

2008-12-08

The objective of this research is to develop a general methodological framework for planning and : evaluating the effectiveness of highway reconstruction strategies on the systems performance : measures, in particular safety, mobility, and the tot...

Investigation of the impact of the I-94 ATM system on the safety of the I-94 commons high crash area : final report.

DOT National Transportation Integrated Search

2014-05-01

Active Traffic Management (ATM) strategies are being deployed in major cities worldwide to deal with pervasive system : congestion and safety concerns. While such strategies include a diverse array of components, in the Twin Cities metropolitan : are...

Argument for a Joint Safety Reporting System

DTIC Science & Technology

2015-02-13

Process Manager for the HQ AF Safety Center (AFSEC) at Kirtland AFB, New Mexico . His primary duties included leadership and oversight of the day-to...Military Mishaps Functional Lead and Navy-Marine Corps Subject Matter Expert ( SME ) for the SIMWG, the DOD Force Risk Reduction system rolls up the service

Safety of High Speed Magnetic Levitation Transportation Systems : Magnetic Field Testing of TR-07 Maglev Vehicle and System. Volume 2. Appendices.

DOT National Transportation Integrated Search

1992-04-01

The safety of various magnetically levitated (maglev) and high speed rail (HSR) trains proposed for application in the United States is of direct concern to the Federal Railroad Administration (FRA). This report catalogs and documents detailed magnet...

Confidential reporting of patient safety events in primary care: results from a multilevel classification of cognitive and system factors.

PubMed

Kostopoulou, Olga; Delaney, Brendan

2007-04-01

To classify events of actual or potential harm to primary care patients using a multilevel taxonomy of cognitive and system factors. Observational study of patient safety events obtained via a confidential but not anonymous reporting system. Reports were followed up with interviews where necessary. Events were analysed for their causes and contributing factors using causal trees and were classified using the taxonomy. Five general medical practices in the West Midlands were selected to represent a range of sizes and types of patient population. All practice staff were invited to report patient safety events. Main outcome measures were frequencies of clinical types of events reported, cognitive types of error, types of detection and contributing factors; and relationship between types of error, practice size, patient consequences and detection. 78 reports were relevant to patient safety and analysable. They included 21 (27%) adverse events and 50 (64%) near misses. 16.7% (13/71) had serious patient consequences, including one death. 75.7% (59/78) had the potential for serious patient harm. Most reports referred to administrative errors (25.6%, 20/78). 60% (47/78) of the reports contained sufficient information to characterise cognition: "situation assessment and response selection" was involved in 45% (21/47) of these reports and was often linked to serious potential consequences. The most frequent contributing factor was work organisation, identified in 71 events. This included excessive task demands (47%, 37/71) and fragmentation (28%, 22/71). Even though most reported events were near misses, events with serious patient consequences were also reported. Failures in situation assessment and response selection, a cognitive activity that occurs in both clinical and administrative tasks, was related to serious potential harm.

Confidential reporting of patient safety events in primary care: results from a multilevel classification of cognitive and system factors

PubMed Central

Kostopoulou, Olga; Delaney, Brendan

2007-01-01

Objective To classify events of actual or potential harm to primary care patients using a multilevel taxonomy of cognitive and system factors. Methods Observational study of patient safety events obtained via a confidential but not anonymous reporting system. Reports were followed up with interviews where necessary. Events were analysed for their causes and contributing factors using causal trees and were classified using the taxonomy. Five general medical practices in the West Midlands were selected to represent a range of sizes and types of patient population. All practice staff were invited to report patient safety events. Main outcome measures were frequencies of clinical types of events reported, cognitive types of error, types of detection and contributing factors; and relationship between types of error, practice size, patient consequences and detection. Results 78 reports were relevant to patient safety and analysable. They included 21 (27%) adverse events and 50 (64%) near misses. 16.7% (13/71) had serious patient consequences, including one death. 75.7% (59/78) had the potential for serious patient harm. Most reports referred to administrative errors (25.6%, 20/78). 60% (47/78) of the reports contained sufficient information to characterise cognition: “situation assessment and response selection” was involved in 45% (21/47) of these reports and was often linked to serious potential consequences. The most frequent contributing factor was work organisation, identified in 71 events. This included excessive task demands (47%, 37/71) and fragmentation (28%, 22/71). Conclusions Even though most reported events were near misses, events with serious patient consequences were also reported. Failures in situation assessment and response selection, a cognitive activity that occurs in both clinical and administrative tasks, was related to serious potential harm. PMID:17403753

Space-Based Range Safety and Future Space Range Applications

NASA Technical Reports Server (NTRS)

Whiteman, Donald E.; Valencia, Lisa M.; Simpson, James C.

2005-01-01

The National Aeronautics and Space Administration Space-Based Telemetry and Range Safety study is a multiphase project to demonstrate the performance, flexibility and cost savings that can be realized by using space-based assets for the Range Safety (global positioning system metric tracking data, flight termination command and range safety data relay) and Range User (telemetry) functions during vehicle launches and landings. Phase 1 included flight testing S-band Range Safety and Range User hardware in 2003 onboard a high-dynamic aircraft platform at Dryden Flight Research Center (Edwards, California) using the NASA Tracking and Data Relay Satellite System as the communications link. The current effort, Phase 2, includes hardware and packaging upgrades to the S-band Range Safety system and development of a high data rate Ku-band Range User system. The enhanced Phase 2 Range Safety Unit provided real-time video for three days during the historic GlobalFlyer (Scaled Composites, Mojave, California) flight in March, 2005. Additional Phase 2 testing will include a sounding rocket test of the Range Safety system and aircraft flight testing of both systems. Future testing will include a flight test on a launch vehicle platform. This report discusses both Range Safety and Range User developments and testing with emphasis on the Range Safety system. The operational concept of a future space-based range is also discussed.

33 CFR 169.100 - What mandatory ship reporting systems are established by this subpart?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false What mandatory ship reporting systems are established by this subpart? 169.100 Section 169.100 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY SHIP REPORTING SYSTEMS Establishment of Two Mandatory Ship Reporting...

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

MITCHELL,GERRY W.; LONGLEY,SUSAN W.; PHILBIN,JEFFREY S.

This Safety Analysis Report (SAR) is prepared in compliance with the requirements of DOE Order 5480.23, Nuclear Safety Analysis Reports, and has been written to the format and content guide of DOE-STD-3009-94 Preparation Guide for U. S. Department of Energy Nonreactor Nuclear Safety Analysis Reports. The Hot Cell Facility is a Hazard Category 2 nonreactor nuclear facility, and is operated by Sandia National Laboratories for the Department of Energy. This SAR provides a description of the HCF and its operations, an assessment of the hazards and potential accidents which may occur in the facility. The potential consequences and likelihood ofmore » these accidents are analyzed and described. Using the process and criteria described in DOE-STD-3009-94, safety-related structures, systems and components are identified, and the important safety functions of each SSC are described. Additionally, information which describes the safety management programs at SNL are described in ancillary chapters of the SAR.« less

An exploration of Australian hospital pharmacists' attitudes to patient safety.

PubMed

Lalor, Daniel J; Chen, Timothy F; Walpola, Ramesh; George, Rachel A; Ashcroft, Darren M; Fois, Romano A

2015-02-01

To explore the attitudes of Australian hospital pharmacists towards patient safety in their work settings. A safety climate questionnaire was administered to all 2347 active members of the Society of Hospital Pharmacists of Australia in 2010. Part of the survey elicited free-text comments about patient safety, error and incident reporting. The comments were subjected to thematic analysis to determine the attitudes held by respondents in relation to patient safety and its quality management in their work settings. Two hundred and ten (210) of 643 survey respondents provided comments on safety and quality issues related to their work settings. The responses contained a number of dominant themes including issues of workforce and working conditions, incident reporting systems, the response when errors occur, the presence or absence of a blame culture, hospital management support for safety initiatives, openness about errors and the value of teamwork. A number of pharmacists described the development of a mature patient-safety culture - one that is open about reporting errors and active in reducing their occurrence. Others described work settings in which a culture of blame persists, stifling error reporting and ultimately compromising patient safety. Australian hospital pharmacists hold a variety of attitudes that reflect diverse workplace cultures towards patient safety, error and incident reporting. This study has provided an insight into these attitudes and the actions that are needed to improve the patient-safety culture within Australian hospital pharmacy work settings. © 2014 Royal Pharmaceutical Society.

Frontline worker perceptions of medication safety in India

PubMed Central

Sharma, Sangeeta; Tabassum, Fauzia; Khurana, Sarbjeet; Kapoor, Kaveri

2016-01-01

Background: To explore interprofessionals’ perceptions about patient safety, particularly medication safety and associated factors and barriers. Methods: A total of 389 respondents were recruited using convenience sample in the cross sectional survey. Results: Medication safety was perceived as somewhat safe (60%). One-third of respondents witnessed 3–4 or more medication errors (MEs) within the past 1 year. Out of that, one quarter were reportedly, sentinel events. More sentinel events were witnessed in public hospitals and solo practice clinics compared with corporate hospitals and nursing homes (p < 0.02). No difference was observed in the occurrence of sentinel events in accredited and nonaccredited facilities (p = 0.30). Younger respondents witnessed more MEs, whereas accredited hospitals (mostly corporate hospitals) witnessed significantly fewer MEs and graded overall safety as ‘better’. However, most MEs go unreported particularly in solo practice clinics (88%) followed by nursing homes (67%), public hospitals (54%), and corporate hospitals (42%). Error identification and subsequent disclosure was inhibited by several system factors: fear of punitive action and lack of reporting systems. General surgical (46%), medical (42%), and paediatric units (36%), were the most error-prone places. Documentation diverted all healthcare workers from direct patient care. Many doctors and pharmacists from nursing homes, solo clinics and public hospitals reported working overtime. Staff shortages and poor training were overwhelming concerns to all healthcare workers and in public hospitals. Solo clinics and nursing homes perceived more barriers; lack of reporting systems, standard protocol, and resources for patient safety and unfamiliarity with prescribed medications was their overwhelming concern. Other factors threatening MEs were a lack of team approach and openness in interdisciplinary communications, illegible medical orders, and medicines prescribed by brand names. Conclusions: Immediate interventions to improve medication safety include enforcement of legible/printed medical orders in generic names, workforce development, developing standard protocols, and a corresponding change in organizational culture. Accreditation can serve as a driver for improving patient safety. PMID:27904743

PRACA Enhancement Pilot Study Report: Engineering for Complex Systems Program (formerly Design for Safety), DFS-IC-0006

NASA Technical Reports Server (NTRS)

Korsmeyer, David; Schreiner, John

2002-01-01

This technology evaluation report documents the findings and recommendations of the Engineering for Complex Systems Program (formerly Design for Safety) PRACA Enhancement Pilot Study of the Space Shuttle Program's (SSP's) Problem Reporting and Corrective Action (PRACA) System. A team at NASA Ames Research Center (ARC) performed this Study. This Study was initiated as a follow-on to the NASA chartered Shuttle Independent Assessment Team (SIAT) review (performed in the Fall of 1999) which identified deficiencies in the current PRACA implementation. The Pilot Study was launched with an initial qualitative assessment and technical review performed during January 2000 with the quantitative formal Study (the subject of this report) started in March 2000. The goal of the PRACA Enhancement Pilot Study is to evaluate and quantify the technical aspects of the SSP PRACA systems and recommend enhancements to address deficiencies and in preparation for future system upgrades.

[EuCliD 5TM Clinic Variance Report: a means to improve the safety of patients and staff].

PubMed

Oggero, Anna Rita; Palmieri, Veronica; Cerreto, Maria; Manna, Luisa; Lettieri, Iolanda; Napoli, Antonio; Ravone, Virginia; Pelliccia, Francesco; Moretti, Manuela; Parisotto, Maria Teresa

2010-01-01

The collection of information about events in the healthcare sector has been documented internationally for more than 25 years. Incident reporting is used for the structured acquisition of information about adverse events to improve patient and healthcare staff safety, prepare corrective action, and prevent event recurrence in the future. The establishment of an incident reporting system requires that the staff involved should be capable of recognizing events which require reporting. The aim of this work was to encourage operators to use the incident reporting system and gradually achieve 100% compliance in the reporting of adverse events and corrective and preventive actions taken. The project was carried out by the staff of one NephroCare dialysis center. The parameters observed were how many times the Variance Report was used, how problems were analyzed, and how many times and by what means the medical and nursing staff took action to correct problems. Ten months from the start of the project 100% reporting was achieved. All selected adverse advents were correctly reported and corrective or preventive action was taken to improve patient care and dialysis center organization. Only effective feedback on the results achieved in terms of safety and tangible improvements by staff will allow the number of reports to be kept high, and maintain participants' compliance with the incident reporting system over the long term.

Independent Evaluation of Heavy-Truck Safety Applications Based on Vehicle-to-Vehicle and Vehicle-to-Infrastructure Communications Used in the Safety Pilot Model Deployment

DOT National Transportation Integrated Search

2016-01-01

This report presents the methodology and results of the independent evaluation of heavy trucks (HTs) in the Safety Pilot Model Deployment (SPMD); part of the United States Department of Transportations Intelligent Transportation Systems research p...

The attributes of medical event-reporting systems: experience with a prototype medical event-reporting system for transfusion medicine.

PubMed

Battles, J B; Kaplan, H S; Van der Schaaf, T W; Shea, C E

1998-03-01

To design, develop, and implement a prototype medical event-reporting system for use in transfusion medicine to improve transfusion safety by studying incidents and errors. The IDEALS concept of design was used to identify specifications for the event-reporting system, and a Delphi and subsequent nominal group technique meetings were used to reach consensus on the development of the system. An interdisciplinary panel of experts from aviation safety, nuclear power, cognitive psychology, artificial intelligence, and education and representatives of major transfusion medicine organizations participated in the development process. Setting.- Three blood centers and three hospital transfusion services implemented the reporting system. A working prototype event-reporting system was recommended and implemented. The system has seven components: detection, selection, description, classification, computation, interpretation, and local evaluation. Its unique features include no-fault reporting initiated by the individual discovering the event, who submits a report that is investigated by local quality assurance personnel and forwarded to a nonregulatory central system for computation and interpretation. An event-reporting system incorporated into present quality assurance and risk management efforts can help organizations address system structural and procedural weakness where the potential for errors can adversely affect health care outcomes. Input from the end users of the system as well as from external experts should enable this reporting system to serve as a useful model for others who may develop event-reporting systems in other medical domains.

CATS-based Agents That Err

NASA Technical Reports Server (NTRS)

Callantine, Todd J.

2002-01-01

This report describes preliminary research on intelligent agents that make errors. Such agents are crucial to the development of novel agent-based techniques for assessing system safety. The agents extend an agent architecture derived from the Crew Activity Tracking System that has been used as the basis for air traffic controller agents. The report first reviews several error taxonomies. Next, it presents an overview of the air traffic controller agents, then details several mechanisms for causing the agents to err in realistic ways. The report presents a performance assessment of the error-generating agents, and identifies directions for further research. The research was supported by the System-Wide Accident Prevention element of the FAA/NASA Aviation Safety Program.

SP-100 Program: space reactor system and subsystem investigations

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

Harty, R.B.

1983-09-30

For a space reactor power system, a comprehensive safety program will be required to assure that no undue risk is present. This report summarizes the nuclear safety review/approval process that will be required for a space reactor system. The documentation requirements are presented along with a summary of the required contents of key documents. Finally, the aerospace safety program conducted for the SNAP-10A reactor system is summarized. The results of this program are presented to show the type of program that can be expected and to provide information that could be usable in future programs.

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

PubMed Central

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

2007-01-01

Background 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. Objective 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. Results 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. Discussion 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. Conclusion 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. PMID:17472749

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

PubMed

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.

Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting team.

PubMed

Crowe, Brenda J; Xia, H Amy; Berlin, Jesse A; Watson, Douglas J; Shi, Hongliang; Lin, Stephen L; Kuebler, Juergen; Schriver, Robert C; Santanello, Nancy C; Rochester, George; Porter, Jane B; Oster, Manfred; Mehrotra, Devan V; Li, Zhengqing; King, Eileen C; Harpur, Ernest S; Hall, David B

2009-10-01

The Safety Planning, Evaluation and Reporting Team (SPERT) was formed in 2006 by the Pharmaceutical Research and Manufacturers of America. SPERT's goal was to propose a pharmaceutical industry standard for safety planning, data collection, evaluation, and reporting, beginning with planning first-in-human studies and continuing through the planning of the post-product-approval period. SPERT's recommendations are based on our review of relevant literature and on consensus reached in our discussions. An important recommendation is that sponsors create a Program Safety Analysis Plan early in development. We also give recommendations for the planning of repeated, cumulative meta-analyses of the safety data obtained from the studies conducted within the development program. These include clear definitions of adverse events of special interest and standardization of many aspects of data collection and study design. We describe a 3-tier system for signal detection and analysis of adverse events and highlight proposals for reducing "false positive" safety findings. We recommend that sponsors review the aggregated safety data on a regular and ongoing basis throughout the development program, rather than waiting until the time of submission. We recognize that there may be other valid approaches. The proactive approach we advocate has the potential to benefit patients and health care providers by providing more comprehensive safety information at the time of new product marketing and beyond.

A systematic review of human factors and ergonomics (HFE)-based healthcare system redesign for quality of care and patient safety.

PubMed

Xie, Anping; Carayon, Pascale

2015-01-01

Healthcare systems need to be redesigned to provide care that is safe, effective and efficient, and meets the multiple needs of patients. This systematic review examines how human factors and ergonomics (HFE) is applied to redesign healthcare work systems and processes and improve quality and safety of care. We identified 12 projects representing 23 studies and addressing different physical, cognitive and organisational HFE issues in a variety of healthcare systems and care settings. Some evidence exists for the effectiveness of HFE-based healthcare system redesign in improving process and outcome measures of quality and safety of care. We assessed risk of bias in 16 studies reporting the impact of HFE-based healthcare system redesign and found varying quality across studies. Future research should further assess the impact of HFE on quality and safety of care, and clearly define the mechanisms by which HFE-based system redesign can improve quality and safety of care.

Information system equality for food security--implementation of the food safety control system in Taiwan.

PubMed

Chen, Shaun C; Hsu, Guoo-Shyng Wang; Chiu, Chihwei P

2009-01-01

Food security plays a central role in governing agricultural policies in Taiwan. In addition to overuse or the illegal use of pesticide, meat leanness promoters, animal drugs and melamine in the food supply; as well as foodborne illness draws the greatest public concern due to incidents that occur every year in Taiwan. The present report demonstrates the implementation of a food safety control system in Taiwan. In order to control foodborne outbreaks effectively, the central government of the Department of Health of Taiwan launched the food safety control system which includes both the good hygienic practice (GHP) and the HACCP plan, in the last decade. From 1998 to the present, 302 food affiliations that implemented the system have been validated and accredited by a well-established audit system. The implementation of a food safety control system in compliance with international standards is of crucial importance to ensure complete safety and the high quality of foods, not only for domestic markets, but also for international trade.

Human factors considerations for the integration of unmanned aerial vehicles in the National Airspace System : an analysis of reports submitted to the Aviation Safety Reporting System (ASRS)

DOT National Transportation Integrated Search

2017-06-06

Successful integration of Unmanned Aerial Vehicle (UAV) operations into the National Airspace System requires the identification and mitigation of operational risks. This report reviews human factors issues that have been identified in operational as...

A review of medication incidents reported to the National Reporting and Learning System in England and Wales over 6 years (2005–2010)

PubMed Central

Cousins, David H; Gerrett, David; Warner, Bruce

2012-01-01

A review of all medication incidents reported to the National Reporting and Learning System (NRLS) in England in Wales between 1 January 2005 and 31 December 2010 was undertaken. The 526 186 medication incident reports represented 9.68% of all patient safety incidents. Medication incidents from acute general hospitals (394 951) represented 75% of reports. There were relatively smaller numbers of medication incident reports (44 952) from primary care, representing 8.5% of the total. Of 86 821 (16%) medication incidents reporting actual patient harm, 822 (0.9%) resulted in death or severe harm. The incidents involving medicine administration (263 228; 50%) and prescribing (97 097; 18%) were the process steps with the largest number of reports. Omitted and delayed medicine (82 028; 16%) and wrong dose (80 170; 15%) represented the largest error categories. Thirteen medicines or therapeutic groups accounted for 377 (46%) of the incidents with outcomes of death or severe harm. The National Patient Safety Agency (NPSA) has issued guidance to help minimize incidents with many of these medicines. Many recent incidents could have been prevented if the NPSA guidance had been better implemented. It is recommended that healthcare organizations in all sectors establish an effective infrastructure to oversee and promote safe medication practice, including an annual medication safety report. In the future, preventable harms from medication incidents can be further minimized by; the continued use of the NRLS to identify and prioritize important actions to improve medication safety, a central organization continuing to issue medication safety guidance to the service and better methods to ensure that the National Health Service has implemented this guidance. PMID:22188210

A Silent Safety Program

NASA Technical Reports Server (NTRS)

Goodin, James Ronald

2006-01-01

NASA's Columbia Accident Investigation Board (CAIB) referred 8 times to the NASA "Silent Safety Program." This term, "Silent Safety Program" was not an original observation but first appeared in the Rogers Commission's Investigation of the Challenger Mishap. The CAIB on page 183 of its report in the paragraph titled 'Encouraging Minority Opinion,' stated "The Naval Reactor Program encourages minority opinions and "bad news." Leaders continually emphasize that when no minority opinions are present, the responsibility for a thorough and critical examination falls to management. . . Board interviews revealed that it is difficult for minority and dissenting opinions to percolate up through the agency's hierarchy. . ." The first question and perhaps the only question is - what is a silent safety program? Well, a silent safety program may be the same as the dog that didn't bark in Sherlock Holmes' "Adventure of the Silver Blaze" because system safety should behave as a devil's advocate for the program barking on every occasion to insure a critical review inclusion. This paper evaluates the NASA safety program and provides suggestions to prevent the recurrence of the silent safety program alluded to in the Challenger Mishap Investigation. Specifically targeted in the CAM report, "The checks and balances the safety system was meant to provide were not working." A silent system safety program is not unique to NASA but could emerge in any and every organization. Principles developed by Irving Janis in his book, Groupthink, listed criteria used to evaluate an organization's cultural attributes that allows a silent safety program to evolve. If evidence validates Jams's criteria, then Jams's recommendations for preventing groupthink can also be used to improve a critical evaluation and thus prevent the development of a silent safety program.

Using Smart Pumps to Understand and Evaluate Clinician Practice Patterns to Ensure Patient Safety

PubMed Central

Mansfield, Jennifer; Jarrett, Steven

2013-01-01

Background: Safety software installed on intravenous (IV) infusion pumps has been shown to positively impact the quality of patient care through avoidance of medication errors. The data derived from the use of smart pumps are often overlooked, although these data provide helpful insight into the delivery of quality patient care. Objective: The objectives of this report are to describe the value of implementing IV infusion safety software and analyzing the data and reports generated by this system. Case study: Based on experience at the Carolinas HealthCare System (CHS), executive score cards provide an aggregate view of compliance rate, number of alerts, overrides, and edits. The report of serious errors averted (ie, critical catches) supplies the location, date, and time of the critical catch, thereby enabling management to pinpoint the end-user for educational purposes. By examining the number of critical catches, a return on investment may be calculated. Assuming 3,328 of these events each year, an estimated cost avoidance would be $29,120,000 per year for CHS. Other reports allow benchmarking between institutions. Conclusion: A review of the data about medication safety across CHS has helped garner support for a medication safety officer position with the goal of ultimately creating a safer environment for the patient. PMID:24474836

The Future of Transportation: Safety, Opportunity, and Innovation

DOT National Transportation Integrated Search

2016-12-30

This report summarizes key findings from the Future of Transportation: Safety, Opportunity, and Innovation thought leadership speaker series held at Volpe, The National Transportation Systems Center, during the summer and fall of 2016.

Motor vehicle attributes : status report

DOT National Transportation Integrated Search

1985-03-01

The Transportation Systems Center (TSC) was requested by the National Highway : Traffic Safety Administration's (NHTSA) Office of Vehicle Research to compile : and computerize a data base of vehicle safety attributes for automobiles and : trucks. The...

A systematic review of Human Factors and Ergonomics (HFE)-based healthcare system redesign for quality of care and patient safety

PubMed Central

Xie, Anping; Carayon, Pascale

2014-01-01

Healthcare systems need to be redesigned to provide care that is safe, effective and efficient, and meets the multiple needs of patients. This systematic review examines how Human Factors and Ergonomics (HFE) is applied to redesign healthcare work systems and processes and improve quality and safety of care. We identified twelve projects representing 23 studies and addressing different physical, cognitive and organizational HFE issues in a variety of healthcare systems and care settings. Some evidence exists for the effectiveness of HFE-based healthcare system redesign in improving process and outcome measures of quality and safety of care. We assessed risk of bias in 16 studies reporting the impact of HFE-based healthcare system redesign and found varying quality across studies. Future research should further assess the impact of HFE on quality and safety of care, and clearly define the mechanisms by which HFE-based system redesign can improve quality and safety of care. Practitioner Summary Existing evidence shows that HFE-based healthcare system redesign has the potential to improve quality of care and patient safety. Healthcare organizations need to recognize the importance of HFE-based healthcare system redesign to quality of care and patient safety, and invest resources to integrate HFE in healthcare improvement activities. PMID:25323570

The medical student as a patient: attitudes towards involvement in the quality and safety of health care.

PubMed

Davis, Rachel E; Joshi, Devavrata; Patel, Krishan; Briggs, M; Vincent, Charles A

2013-10-01

In recent years, factors that affect patients' willingness and ability to participate in safety-relevant behaviours have been investigated. However, how trained healthcare professionals or medical students would feel participating in safety-relevant behaviours as a patient in hospital remains largely unexplored. To investigate medical students' willingness to participate in behaviours related to the quality and safety of their health care. A cross-sectional exploratory study using a survey that addressed willingness to participate in different behaviours recommended by current patient safety initiatives. Three types of interactional behaviours (asking factual or challenging questions, notifying doctors or nurses of errors/problems) and three non-interactional behaviours (choosing a hospital based on the safety record, bringing medicines and a list of allergies into hospital, and reporting an error to a national reporting system) were assessed. One hundred and seventy-nine medical students from an inner city London teaching hospital participated in the study. Students' willingness to participate was affected (P < 0.05) by the action required by the patient and (for interactional behaviours) whether the patient was engaging in the specific action with a doctor or nurse. Students were least willing to ask 'challenging' questions to doctors and nurses and to report errors to a national reporting system. Doctors' and nurses' encouragement appeared to increase self-reported willingness to participate in behaviours where baseline willingness was low. Similar to research on lay patient populations; medical students do not view involvement in safety-related behaviours equally. Interventions should be tailored at encouraging students to participate in behaviours they are less inclined to take on an active role in. Future research is required to examine students' motivations for participation in this important but heavily under-researched area. © 2012 John Wiley & Sons Ltd.

Tranzit XPress : hazardous material fleet management and monitoring system : evaluation report

DOT National Transportation Integrated Search

1997-07-01

In this report the evaluation performed on the first phase of the Tranzit XPress system is presented. The system comprises of a traffic/safety control center, motor vehicle instrumentation, and a variety of off vehicle tools that communicate with eac...

77 FR 76299 - Towing Safety Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-27

... system (AIS), and plans to improve Coast Guard Form 2692 for reporting a marine accident, injury or death... System (AIS), and (c) Plans to improve Coast Guard Form 2692, REPORT OF MARINE ACCIDENT, INJURY OR DEATH...

10 CFR 52.79 - Contents of applications; technical information in final safety analysis report.

Code of Federal Regulations, 2010 CFR

2010-01-01

... assurance program will be implemented; (26) The applicant's organizational structure, allocations or... presents a safety analysis of the structures, systems, and components of the facility as a whole. The final... contain an analysis and evaluation of the major structures, systems, and components of the facility that...

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

Code of Federal Regulations, 2010 CFR

2010-01-01

... analysis of the structures, systems, and components of the reactor to be manufactured, with emphasis upon... assumed for this evaluation should be based upon a major accident, hypothesized for purposes of site... structures, systems, and components with the objective of assessing the risk to public health and safety...

Tracking Progress in Improving Diagnosis: A Framework for Defining Undesirable Diagnostic Events.

PubMed

Olson, Andrew P J; Graber, Mark L; Singh, Hardeep

2018-01-29

Diagnostic error is a prevalent, harmful, and costly phenomenon. Multiple national health care and governmental organizations have recently identified the need to improve diagnostic safety as a high priority. A major barrier, however, is the lack of standardized, reliable methods for measuring diagnostic safety. Given the absence of reliable and valid measures for diagnostic errors, we need methods to help establish some type of baseline diagnostic performance across health systems, as well as to enable researchers and health systems to determine the impact of interventions for improving the diagnostic process. Multiple approaches have been suggested but none widely adopted. We propose a new framework for identifying "undesirable diagnostic events" (UDEs) that health systems, professional organizations, and researchers could further define and develop to enable standardized measurement and reporting related to diagnostic safety. We propose an outline for UDEs that identifies both conditions prone to diagnostic error and the contexts of care in which these errors are likely to occur. Refinement and adoption of this framework across health systems can facilitate standardized measurement and reporting of diagnostic safety.

Assessment of the State-of-the-Art of System-Wide Safety and Assurance Technologies

NASA Technical Reports Server (NTRS)

Roychoudhury, Indranil; Reveley, Mary S.; Phojanamongkolkij, Nipa; Leone, Karen M.

2017-01-01

Since its initiation, the System-wide Safety Assurance Technologies (SSAT) Project has been focused on developing multidisciplinary tools and techniques that are verified and validated to ensure prevention of loss of property and life in NextGen and enable proactive risk management through predictive methods. To this end, four technical challenges have been listed to help realize the goals of SSAT, namely (i) assurance of flight critical systems, (ii) discovery of precursors to safety incidents, (iii) assuring safe human-systems integration, and (iv) prognostic algorithm design for safety assurance. The objective of this report is to provide an extensive survey of SSAT-related research accomplishments by researchers within and outside NASA to get an understanding of what the state-of-the-art is for technologies enabling each of the four technical challenges. We hope that this report will serve as a good resource for anyone interested in gaining an understanding of the SSAT technical challenges, and also be useful in the future for project planning and resource allocation for related research.

Surface Movement Incidents Reported to the NASA Aviation Safety Reporting System

NASA Technical Reports Server (NTRS)

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.

System Safety in an IT Service Organization

NASA Astrophysics Data System (ADS)

Parsons, Mike; Scutt, Simon

Within Logica UK, over 30 IT service projects are considered safetyrelated. These include operational IT services for airports, railway infrastructure asset management, nationwide radiation monitoring and hospital medical records services. A recent internal audit examined the processes and documents used to manage system safety on these services and made a series of recommendations for improvement. This paper looks at the changes and the challenges to introducing them, especially where the service is provided by multiple units supporting both safety and non-safety related services from multiple locations around the world. The recommendations include improvements to service agreements, improved process definitions, routine safety assessment of changes, enhanced call logging, improved staff competency and training, and increased safety awareness. Progress is reported as of today, together with a road map for implementation of the improvements to the service safety management system. A proposal for service assurance levels (SALs) is discussed as a way forward to cover the wide variety of services and associated safety risks.

Classification of antecedents towards safety use of health information technology: A systematic review.

PubMed

Salahuddin, Lizawati; Ismail, Zuraini

2015-11-01

This paper provides a systematic review of safety use of health information technology (IT). The first objective is to identify the antecedents towards safety use of health IT by conducting systematic literature review (SLR). The second objective is to classify the identified antecedents based on the work system in Systems Engineering Initiative for Patient Safety (SEIPS) model and an extension of DeLone and McLean (D&M) information system (IS) success model. A systematic literature review (SLR) was conducted from peer-reviewed scholarly publications between January 2000 and July 2014. SLR was carried out and reported based on the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement. The related articles were identified by searching the articles published in Science Direct, Medline, EMBASE, and CINAHL databases. Data extracted from the resultant studies included are to be analysed based on the work system in Systems Engineering Initiative for Patient Safety (SEIPS) model, and also from the extended DeLone and McLean (D&M) information system (IS) success model. 55 articles delineated to be antecedents that influenced the safety use of health IT were included for review. Antecedents were identified and then classified into five key categories. The categories are (1) person, (2) technology, (3) tasks, (4) organization, and (5) environment. Specifically, person is attributed by competence while technology is associated to system quality, information quality, and service quality. Tasks are attributed by task-related stressor. Organisation is related to training, organisation resources, and teamwork. Lastly, environment is attributed by physical layout, and noise. This review provides evidence that the antecedents for safety use of health IT originated from both social and technical aspects. However, inappropriate health IT usage potentially increases the incidence of errors and produces new safety risks. The review cautions future implementation and adoption of health IT to carefully consider the complex interactions between social and technical elements propound in healthcare settings. Copyright © 2015. Published by Elsevier Ireland Ltd.

Error Generation in CATS-Based Agents

NASA Technical Reports Server (NTRS)

Callantine, Todd

2003-01-01

This research presents a methodology for generating errors from a model of nominally preferred correct operator activities, given a particular operational context, and maintaining an explicit link to the erroneous contextual information to support analyses. It uses the Crew Activity Tracking System (CATS) model as the basis for error generation. This report describes how the process works, and how it may be useful for supporting agent-based system safety analyses. The report presents results obtained by applying the error-generation process and discusses implementation issues. The research is supported by the System-Wide Accident Prevention Element of the NASA Aviation Safety Program.

Training for laparoscopic pancreaticoduodenectomy.

PubMed

Kuroki, Tamotsu; Fujioka, Hikaru

2018-05-10

In recent years, laparoscopic procedures have developed rapidly, and the reports of laparoscopic pancreatic resection including laparoscopic pancreaticoduodenectomy (LPD) have increased in number. Although LPD is a complex procedure with high mortality, the training system for LPD remains unestablished. Ensuring patient safety is extremely important, even in challenging surgeries such a LPD. At present, several tools have been developed for surgical education to ensure patient safety preoperatively, such as video learning, virtual reality simulators, and cadaver training. Although LPD is reported as a safe and feasible choice, LPD is still a challenging operation. An LPD training system should be established with a board-certified system.

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

PubMed

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

2017-03-27

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

Comparing international crash statistics

DOT National Transportation Integrated Search

1999-12-01

In order to examine national developments in traffic safety, crash statistics from several of the more safety, crash statistics from several of the more United States. Data obtained from the Fatality Analysis Reporting System (FARS) and the Internati...

Two-lane rural highways safety performance functions.

DOT National Transportation Integrated Search

2016-05-01

This report documents findings from a comprehensive set of safety performance functions developed for the entire : state two-lane rural highway system in Washington. The findings indicate that random parameter models and : heterogeneous negative bino...

77 FR 22322 - Common Formats for Patient Safety Data Collection and Event Reporting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-13

... Safety Databases (NPSD). The Common Formats include two general types of formats, generic and event... Common Formats. The inventory includes many systems from the private sector, including prominent academic...

77 FR 42736 - Common Formats for Patient Safety Data Collection and Event Reporting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-20

... Safety Databases (NPSD). Since the initial release of the Common Formats in August 2008, AHRQ has.... The inventory includes many systems from the private sector, including prominent academic settings...

Enhancing rail safety now and into the 21st century : the Federal Railroad Administration's safety programs and initiatives : a report to Congress

DOT National Transportation Integrated Search

1996-10-01

By law, the Federal Railroad Administration (FRA) has responsibility for ensuring railroad safety throughout the nation. The United States railroad system consists of over 600 railroads with more than 250,000 employees, 200,000 miles of track, 1.2 mi...

Practice gaps in patient safety among dermatology residents and their teachers: a survey study of dermatology residents.

PubMed

Swary, Jillian Havey; Stratman, Erik J

2014-07-01

Curriculum and role modeling adjustments are necessary to address patient safety gaps occurring during dermatology residency. To identify the source of clinical practices among dermatology residents that affect patient safety and determine the best approach for overcoming gaps in knowledge and practice patterns that contribute to these practices. A survey-based study, performed at a national medical dermatology meeting in Itasca, Illinois, in 2012, included 142 dermatology residents from 44 residency programs in the United States and Canada. Self-reported rates of dermatology residents committing errors, identifying local systems errors, and identifying poor patient safety role modeling. Of surveyed dermatology residents, 45.2% have failed to report needle-stick injuries incurred during procedures, 82.8% reported cutting and pasting a previous author's patient history information into a medical record without confirming its validity, 96.7% reported right-left body part mislabeling during examination or biopsy, and 29.4% reported not incorporating clinical photographs of lesions sampled for biopsy in the medical record at their institution. Residents variably perform a purposeful pause ("time-out") when indicated to confirm patient, procedure, and site before biopsy, with 20.0% always doing so. In addition, 59.7% of residents work with at least 1 attending physician who intimidates the residents, reducing the likelihood of reporting safety issues they witness. Finally, 78.3% have witnessed attending physicians purposefully disregarding required safety steps. Our data reinforce the need for modified curricula, systems, and teacher development to reduce injuries, improve communication with patients and between physicians, residents, and other members of the health care team, and create an environment free of intimidation.

Development and validation of Aviation Causal Contributors for Error Reporting Systems (ACCERS).

PubMed

Baker, David P; Krokos, Kelley J

2007-04-01

This investigation sought to develop a reliable and valid classification system for identifying and classifying the underlying causes of pilot errors reported under the Aviation Safety Action Program (ASAP). ASAP is a voluntary safety program that air carriers may establish to study pilot and crew performance on the line. In ASAP programs, similar to the Aviation Safety Reporting System, pilots self-report incidents by filing a short text description of the event. The identification of contributors to errors is critical if organizations are to improve human performance, yet it is difficult for analysts to extract this information from text narratives. A taxonomy was needed that could be used by pilots to classify the causes of errors. After completing a thorough literature review, pilot interviews and a card-sorting task were conducted in Studies 1 and 2 to develop the initial structure of the Aviation Causal Contributors for Event Reporting Systems (ACCERS) taxonomy. The reliability and utility of ACCERS was then tested in studies 3a and 3b by having pilots independently classify the primary and secondary causes of ASAP reports. The results provided initial evidence for the internal and external validity of ACCERS. Pilots were found to demonstrate adequate levels of agreement with respect to their category classifications. ACCERS appears to be a useful system for studying human error captured under pilot ASAP reports. Future work should focus on how ACCERS is organized and whether it can be used or modified to classify human error in ASAP programs for other aviation-related job categories such as dispatchers. Potential applications of this research include systems in which individuals self-report errors and that attempt to extract and classify the causes of those events.

Integrated vehicle-based safety systems heavy-truck on-road test report

DOT National Transportation Integrated Search

2008-08-01

This report presents results from a series of on-road verification tests performed to determine the readiness of a prototype : integrated warning system to advance to field testing, as well as to identify areas of system performance that should be im...

Integrated vehicle-based safety systems light-vehicle on-road test report

DOT National Transportation Integrated Search

2008-08-01

This report presents results from a series of on-road verification tests performed to determine the readiness of a prototype : integrated warning system to advance to field testing, as well as to identify areas of system performance that should be im...

International recommendations for national patient safety incident reporting systems: an expert Delphi consensus-building process.

PubMed

Howell, Ann-Marie; Burns, Elaine M; Hull, Louise; Mayer, Erik; Sevdalis, Nick; Darzi, Ara

2017-02-01

Patient safety incident reporting systems (PSRS) have been established for over a decade, but uncertainty remains regarding the role that they can and ought to play in quantifying healthcare-related harm and improving care. To establish international, expert consensus on the purpose of PSRS regarding monitoring and learning from incidents and developing recommendations for their future role. After a scoping review of the literature, semi-structured interviews with experts in PSRS were conducted. Based on these findings, a survey-based questionnaire was developed and subsequently completed by a larger expert panel. Using a Delphi approach, consensus was reached regarding the ideal role of PSRSs. Recommendations for best practice were devised. Forty recommendations emerged from the Delphi procedure on the role and use of PSRS. Experts agreed reporting system should not be used as an epidemiological tool to monitor the rate of harm over time or to appraise the relative safety of hospitals. They agreed reporting is a valuable mechanism for identifying organisational safety needs. The benefit of a national system was clear with respect to medication error, device failures, hospital-acquired infections and never events as these problems often require solutions at a national level. Experts recommended training for senior healthcare professionals in incident investigation. Consensus recommendation was for hospitals to take responsibility for creating safety solutions locally that could be shared nationally. We obtained reasonable consensus among experts on aims and specifications of PSRS. This information can be used to reflect on existing and future PSRS, and their role within the wider patient safety landscape. The role of PSRS as instruments for learning needs to be elaborated and developed further internationally. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Intelligent transportation systems benefits, costs, and lessons learned : 2005 update

DOT National Transportation Integrated Search

2005-05-01

Intelligent Transportation Systems (ITS) technologies offer a clear opportunity to improve transportation safety, relieve congestion, and enhance productivity. This report is a continuation of a series of reports providing a synthesis of the informat...

[Quality management and safety culture in medicine: context and concepts].

PubMed

Wischet, Werner; Eitzinger, Claudia

2009-01-01

The publication of the IOM report "To err is human: building a safer health system" in 1999 put spotlight on the primacy of the principle of primum non nocere and made patient safety a central topic of quality management. A key conclusion of the report was the need for a well-developed safety culture. While concepts of quality management have evolved along the lines of ISO and Total Quality Management over the last decades patient safety still has not got the same amount of attention (PubMed). Evidence from other safety-critical areas but also from the field of medicine itself suggests that an efficient culture of safety is a conditio sine qua non for the sustainable improvement of patient safety. Considering these arguments the present paper aims at emphasizing the importance of an efficient culture of safety for patient safety and quality management in healthcare. In addition, key instruments of safety culture as well as their limitations will be presented.

Hair removal for Fitzpatrick skin types V and VI using light and heat energy technology.

PubMed

Sadick, Neil S; Krespi, Yoseph

2006-09-01

To determine the safety and efficacy of a light and heat energy (LHE)-based system (SkinStaion system; Radiancy Inc, Orangeburg, NY, USA) for hair removal in subjects with skin types V and VI. Thirty-one subjects with Fitzpatrick skin types V and VI were consented for treatment with the system. Twenty-six subjects completed the 12-week follow-up. Safety was evaluated at each visit and efficacy was evaluated at both follow-up visits. An average hair clearance of 41.7% from 57 treatment sites was reported at the 6-week follow-up visit and a 35.5% average hair clearance was reported at the 12-week follow-up. Edema was only reported in 2 cases (7.7%) of the study population. Eleven cases of erythema were reported following treatment. Treatment with the modified LHE system was safe and effective for hair removal in patients with skin types V and VI.

Application of Microprocessor-Based Equipment in Nuclear Power Plants - Technical Basis for a Qualification Methodology

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

Korsah, K.

This document (1) summarizes the most significant findings of the ''Qualification of Advanced Instrumentation and Control (I&C) Systems'' program initiated by the Nuclear Regulatory Commission (NRC); (2) documents a comparative analysis of U.S. and European qualification standards; and (3) provides recommendations for enhancing regulatory guidance for environmental qualification of microprocessor-based safety-related systems. Safety-related I&C system upgrades of present-day nuclear power plants, as well as I&C systems of Advanced Light-Water Reactors (ALWRs), are expected to make increasing use of microprocessor-based technology. The Nuclear Regulatory Commission (NRC) recognized that the use of such technology may pose environmental qualification challenges different from current,more » analog-based I&C systems. Hence, it initiated the ''Qualification of Advanced Instrumentation and Control Systems'' program. The objectives of this confirmatory research project are to (1) identify any unique environmental-stress-related failure modes posed by digital technologies and their potential impact on the safety systems and (2) develop the technical basis for regulatory guidance using these findings. Previous findings from this study have been documented in several technical reports. This final report in the series documents a comparative analysis of two environmental qualification standards--Institute of Electrical and Electronics Engineers (IEEE) Std 323-1983 and International Electrotechnical Commission (IEC) 60780 (1998)--and provides recommendations for environmental qualification of microprocessor-based systems based on this analysis as well as on the findings documented in the previous reports. The two standards were chosen for this analysis because IEEE 323 is the standard used in the U.S. for the qualification of safety-related equipment in nuclear power plants, and IEC 60780 is its European counterpart. In addition, the IEC document was published in 1998, and should reflect any new qualification concerns, from the European perspective, with regard to the use of microprocessor-based safety systems in power plants.« less

SCI Hazard Report Methodology

NASA Technical Reports Server (NTRS)

Mitchell, Michael S.

2010-01-01

This slide presentation reviews the methodology in creating a Source Control Item (SCI) Hazard Report (HR). The SCI HR provides a system safety risk assessment for the following Ares I Upper Stage Production Contract (USPC) components (1) Pyro Separation Systems (2) Main Propulsion System (3) Reaction and Roll Control Systems (4) Thrust Vector Control System and (5) Ullage Settling Motor System components.

Transportation statistics annual report 1999

DOT National Transportation Integrated Search

1999-01-01

The Bureau of Transportation Statistics (BTS) presents the sixth : Transportation Statistics Annual Report. Mandated by Congress, the report : discusses the U.S. transportation system, including its physical components, : economic performance, safety...

Control of Suspect/Counterfeit and Defective Items

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

Sheriff, Marnelle L.

2013-09-03

This procedure implements portions of the requirements of MSC-MP-599, Quality Assurance Program Description. It establishes the Mission Support Alliance (MSA) practices for minimizing the introduction of and identifying, documenting, dispositioning, reporting, controlling, and disposing of suspect/counterfeit and defective items (S/CIs). employees whose work scope relates to Safety Systems (i.e., Safety Class [SC] or Safety Significant [SS] items), non-safety systems and other applications (i.e., General Service [GS]) where engineering has determined that their use could result in a potential safety hazard. MSA implements an effective Quality Assurance (QA) Program providing a comprehensive network of controls and verification providing defense-in-depth by preventingmore » the introduction of S/CIs through the design, procurement, construction, operation, maintenance, and modification of processes. This procedure focuses on those safety systems, and other systems, including critical load paths of lifting equipment, where the introduction of S/CIs would have the greatest potential for creating unsafe conditions.« less

Can Disproportionality Analysis of Post-marketing Case Reports be Used for Comparison of Drug Safety Profiles?

PubMed

Michel, Christiane; Scosyrev, Emil; Petrin, Michael; Schmouder, Robert

2017-05-01

Clinical trials usually do not have the power to detect rare adverse drug reactions. Spontaneous adverse reaction reports as for example available in post-marketing safety databases such as the FDA Adverse Event Reporting System (FAERS) are therefore a valuable source of information to detect new safety signals early. To screen such large data-volumes for safety signals, data-mining algorithms based on the concept of disproportionality have been developed. Because disproportionality analysis is based on spontaneous reports submitted for a large number of drugs and adverse event types, one might consider using these data to compare safety profiles across drugs. In fact, recent publications have promoted this practice, claiming to provide guidance on treatment decisions to healthcare decision makers. In this article we investigate the validity of this approach. We argue that disproportionality cannot be used for comparative drug safety analysis beyond basic hypothesis generation because measures of disproportionality are: (1) missing the incidence denominators, (2) subject to severe reporting bias, and (3) not adjusted for confounding. Hypotheses generated by disproportionality analyses must be investigated by more robust methods before they can be allowed to influence clinical decisions.

Attitudes toward the large-scale implementation of an incident reporting system.

PubMed

Braithwaite, Jeffrey; Westbrook, Mary; Travaglia, Joanne

2008-06-01

An electronic Incident Information Management System implemented system-wide by the Department of Health, New South Wales, Australia was evaluated. We hypothesized that health professionals (i) would support the system via utilization and favourable attitudes and (ii) that their usage and attitudes would vary according to profession with nurses being most, and doctors least, favourably disposed. An online, anonymous questionnaire survey of 2185 health practitioners. Undertaking system training, satisfaction with training, reporting incidents, incident reporting rates since system introduction and attitude questions focusing on use, security and evaluation of the system and workplace safety cultures. The first hypothesis received partial support. The majority of respondents had undertaken training and rated it highly. Most had reported incidents and maintained their previous reporting levels. Most attitudes regarding using the system and its security were favourable. Mixed attitudes were held about workplace safety cultures and the value of the system. Deficiencies in quality of reporting, feedback on incident reports and resources to analyse incident data were problems identified. The second hypothesis was confirmed. Nurses were most, and doctors least, likely to undertake training, report incidents and express favourable attitudes. Allied health responses were intermediate to those of the other professions. The system implementation was relatively successful, but more so with some professions. Problems identified indicated that expectations as to the goals achievable in the short term were optimistic, but these are amenable to planned interventions.

Applying the Toyota Production System: using a patient safety alert system to reduce error.

PubMed

Furman, Cathie; Caplan, Robert

2007-07-01

In 2002, Virginia Mason Medical Center (VMMC) adapted the Toyota Production System, also known as lean manufacturing. To translate the techniques of zero defects and stopping the line into health care, the Patient Safety Alert (PSA) system requires any employee who encounters a situation that is likely to harm a patient to make an immediate report and to cease any activity that could cause further harm (stopping the line). IMPLEMENTING THE PSA SYSTEM--STOPPING THE LINE: If any VMMC employee's practice or conduct is deemed capable of causing harm to a patient, a PSA can cause that person to be stopped from working until the problem is resolved. A policy statement, senior executive commitment, dedicated resources, a 24-hour hotline, and communication were all key features of implementation. As of December 2006, 6,112 PSA reports were received: 20% from managers, 8% from physicians, 44% from nurses, and 23% from nonclinical support personnel, for example. The number of reports received per month increased from an average of 3 in 2002 to 285 in 2006. Most reports were processed within 24 hours and were resolved within 2 to 3 weeks. Implementing the PSA system has drastically increased the number of safety concerns that are resolved at VMMC, while drastically reducing the time it takes to resolve them. Transparent discussion and feedback have helped promote staff acceptance and participation.

Can incident reporting improve safety? Healthcare practitioners' views of the effectiveness of incident reporting.

PubMed

Anderson, Janet E; Kodate, Naonori; Walters, Rhiannon; Dodds, Anneliese

2013-04-01

Recent critiques of incident reporting suggest that its role in managing safety has been over emphasized. The objective of this study was to examine the perceived effectiveness of incident reporting in improving safety in mental health and acute hospital settings by asking staff about their perceptions and experiences. Qualitative research design using documentary analysis and semi-structured interviews. Two large teaching hospitals in London; one providing acute and the other mental healthcare. Sixty-two healthcare practitioners with experience of reporting and analysing incidents. Incident reporting was perceived as having a positive effect on safety, not only by leading to changes in care processes but also by changing staff attitudes and knowledge. Staff discussed examples of both instrumental and conceptual uses of the knowledge generated by incident reports. There are difficulties in using incident reports to improve safety in healthcare at all stages of the incident reporting process. Differences in the risks encountered and the organizational systems developed in the two hospitals to review reported incidents could be linked to the differences we found in attitudes to incident reporting between the two hospitals. Incident reporting can be a powerful tool for developing and maintaining an awareness of risks in healthcare practice. Using incident reports to improve care is challenging and the study highlighted the complexities involved and the difficulties faced by staff in learning from incident data.

Development of an automated assessment tool for MedWatch reports in the FDA adverse event reporting system.

PubMed

Han, Lichy; Ball, Robert; Pamer, Carol A; Altman, Russ B; Proestel, Scott

2017-09-01

As the US Food and Drug Administration (FDA) receives over a million adverse event reports associated with medication use every year, a system is needed to aid FDA safety evaluators in identifying reports most likely to demonstrate causal relationships to the suspect medications. We combined text mining with machine learning to construct and evaluate such a system to identify medication-related adverse event reports. FDA safety evaluators assessed 326 reports for medication-related causality. We engineered features from these reports and constructed random forest, L1 regularized logistic regression, and support vector machine models. We evaluated model accuracy and further assessed utility by generating report rankings that represented a prioritized report review process. Our random forest model showed the best performance in report ranking and accuracy, with an area under the receiver operating characteristic curve of 0.66. The generated report ordering assigns reports with a higher probability of medication-related causality a higher rank and is significantly correlated to a perfect report ordering, with a Kendall's tau of 0.24 ( P  = .002). Our models produced prioritized report orderings that enable FDA safety evaluators to focus on reports that are more likely to contain valuable medication-related adverse event information. Applying our models to all FDA adverse event reports has the potential to streamline the manual review process and greatly reduce reviewer workload. Published by Oxford University Press on behalf of the American Medical Informatics Association 2017. This work is written by US Government employees and is in the public domain in the United States.

Modeling and Analysis of Mixed Synchronous/Asynchronous Systems

NASA Technical Reports Server (NTRS)

Driscoll, Kevin R.; Madl. Gabor; Hall, Brendan

2012-01-01

Practical safety-critical distributed systems must integrate safety critical and non-critical data in a common platform. Safety critical systems almost always consist of isochronous components that have synchronous or asynchronous interface with other components. Many of these systems also support a mix of synchronous and asynchronous interfaces. This report presents a study on the modeling and analysis of asynchronous, synchronous, and mixed synchronous/asynchronous systems. We build on the SAE Architecture Analysis and Design Language (AADL) to capture architectures for analysis. We present preliminary work targeted to capture mixed low- and high-criticality data, as well as real-time properties in a common Model of Computation (MoC). An abstract, but representative, test specimen system was created as the system to be modeled.

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

PubMed

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

2015-03-01

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

Injury risks of EMS responders: evidence from the National Fire Fighter Near-Miss Reporting System

PubMed Central

Taylor, Jennifer A; Davis, Andrea L; Barnes, Brittany; Lacovara, Alicia V; Patel, Reema

2015-01-01

Objectives We analysed near-miss and injury events reported to the National Fire Fighter Near-Miss Reporting System (NFFNMRS) to investigate the workplace hazards and safety concerns of Emergency Medical Services (EMS) responders in the USA. Methods We reviewed 769 ‘non-fire emergency event’ reports from the NFFNMRS using a mixed methods approach. We identified 185 emergency medical calls and analysed their narrative text fields. We assigned Mechanism of Near-Miss/Injury and Nature of Injury codes and then tabulated frequencies (quantitative). We coded major themes regarding work hazards and safety concerns reported by the EMS responders (qualitative). Results Of the 185 emergency medical calls, the most commonly identified Mechanisms of Near-Miss/Injury to EMS responders was Assaults, followed by Struck-by Motor Vehicle, and Motor Vehicle Collision. The most commonly identified weapon used in an assault was a firearm. We identified 5 major domains of workplace hazards and safety concerns: Assaults by Patients, Risks from Motor Vehicles, Personal Protective Equipment, Relationships between Emergency Responders, and Policies, Procedures and Practices. Conclusions Narrative text from the NFFNMRS is a rich source of data that can be analysed quantitatively and qualitatively to provide insight into near-misses and injuries sustained by EMS responders. Near-miss reporting systems are critical components for occupational hazard surveillance. PMID:26068510

Manned space flight nuclear system safety. Volume 7: Literature review. Part 1: Literature search and evaluation

NASA Technical Reports Server (NTRS)

1972-01-01

A review of the literature used in conducting the manned space flight nuclear system safety study is presented. The objectives of the presentation are to identify and evaluate for potential application to study the existing related literature and to provide the information required to include the related literature in the NASA Aerospace Safety Research and Data Institute. More than 15,000 documents were evaluated and identification forms were prepared for 850 reports.

Annual Report by Aerospace Safety Advisory Panel

NASA Technical Reports Server (NTRS)

1980-01-01

Elements of the shuttle program that directly affect the mission success and crew safety were investigated. These elements included the shuttle orbiter, the main engine, the solid rocket boosters, avionic system, ground support equipment and the approach and landing operations. The thermal protection systems were studied in detail. Crew training and ground simulation test procedures were reviewed.

Implementation plan and cost analysis for Oregon's online crash reporting system.

DOT National Transportation Integrated Search

2011-07-01

Federal, state and local transportation agencies, law enforcement, the legislature, consulting firms, safety advocates and the : public use crash data to quantify emerging traffic safety issues and problems, determine priorities, support decision-mak...

Motor Carrier Safety Fitness Determination: An Improved Process

DOT National Transportation Integrated Search

1996-12-01

PREFACE This report was undertaken to define an improved process for motor carrier safety fitness determination. It was produced by the Research and Special Program Administration's (RSPA} John A. Volpe National Transportation Systems Center (the Vol...

Implementing instructions for KSC systems and safety training

NASA Technical Reports Server (NTRS)

1973-01-01

The requirements for the safety training program are reported for KSC including transportation, inspection, checkout operations, maintenance of launch vehicles, spacecraft, ground support equipment, and launch teams. The responsibilities and mechanics for implementing the program are outlined.

The Impact of Community-Based Outreach on Psychological Distress and Victim Safety in Women Exposed to Intimate Partner Abuse

ERIC Educational Resources Information Center

DePrince, Anne P.; Labus, Jennifer; Belknap, Joanne; Buckingham, Susan; Gover, Angela

2012-01-01

Objective: Using a longitudinal, randomized controlled trial, this study assessed the impact of a community-based outreach versus a more traditional criminal justice system-based referral program on women's distress and safety following police-reported intimate partner abuse (IPA). Method: Women (N = 236 women) with police-reported IPA were…

Confidential close call reporting system : preliminary evaluation findings.

DOT National Transportation Integrated Search

2008-12-01

The Federal Railroad Administration (FRA) is implementing a collaborative problem-solving approach to improving safety. The Confidential Close Call Reporting System (C3RS) is a human factors-based approach that is designed to reduce the accident rate...

75 FR 49869 - Changes to Standard Numbering System, Vessel Identification System, and Boating Accident Report...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-16

... Boating Accident Report Database AGENCY: Coast Guard, DHS. ACTION: Reopening of public comment period... Boating Accident Report Database. DATES: Comments and related material must either be submitted to our... Database that, collectively, are intended to improve recreational boating safety efforts, enhance law...

33 CFR 169.235 - What exemptions are there from reporting?

Code of Federal Regulations, 2012 CFR

2012-07-01

... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY SHIP REPORTING SYSTEMS Transmission of Long Range Identification and Tracking Information § 169.235 What exemptions are there from reporting? A ship is exempt from this subpart if it is— (a) Fitted with an operating automatic identification system (AIS), under 33 CFR...

33 CFR 169.235 - What exemptions are there from reporting?

Code of Federal Regulations, 2011 CFR

2011-07-01

... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY SHIP REPORTING SYSTEMS Transmission of Long Range Identification and Tracking Information § 169.235 What exemptions are there from reporting? A ship is exempt from this subpart if it is— (a) Fitted with an operating automatic identification system (AIS), under 33 CFR...

33 CFR 169.235 - What exemptions are there from reporting?

Code of Federal Regulations, 2013 CFR

2013-07-01

... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY SHIP REPORTING SYSTEMS Transmission of Long Range Identification and Tracking Information § 169.235 What exemptions are there from reporting? A ship is exempt from this subpart if it is— (a) Fitted with an operating automatic identification system (AIS), under 33 CFR...

33 CFR 169.235 - What exemptions are there from reporting?

Code of Federal Regulations, 2014 CFR

2014-07-01

... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY SHIP REPORTING SYSTEMS Transmission of Long Range Identification and Tracking Information § 169.235 What exemptions are there from reporting? A ship is exempt from this subpart if it is— (a) Fitted with an operating automatic identification system (AIS), under 33 CFR...

What Does a Hospital Survey on Patient Safety Reveal About Patient Safety Culture of Surgical Units Compared With That of Other Units?

PubMed

Shu, Qin; Cai, Miao; Tao, Hong-Bing; Cheng, Zhao-Hui; Chen, Jing; Hu, Yin-Huan; Li, Gang

2015-07-01

The objective of this study was to examine the strengths and weaknesses of surgical units as compared with other units, and to provide an opportunity to improve patient safety culture in surgical settings by suggesting targeted actions using Hospital Survey on Patient Safety Culture (HSOPSC) investigation.A Hospital Survey on Patient Safety questionnaire was conducted to physicians and nurses in a tertiary hospital in Shandong China. 12 patient safety culture dimensions and 2 outcome variables were measured.A total of 23.5% of respondents came from surgical units, and 76.5% worked in other units. The "overall perceptions of safety" (48.1% vs 40.4%, P < 0.001) and "frequency of events reported" (63.7% vs 60.7%, P = 0.001) of surgical units were higher than those of other units. However, the communication openness (38.7% vs 42.5%, P < 0.001) of surgical units was lower than in other units. Medical workers in surgical units reported more events than those in other units, and more respondents in the surgical units assess "patient safety grade" to be good/excellent. Three dimensions were considered as strengths, whereas 5 other dimensions were considered to be weaknesses in surgical units. Six dimensions have potential to aid in improving events reporting and patient safety grade. Appropriate working times will also contribute to ensuring patient safety. Medical staff with longer years of experience reported more events.Surgical units outperform the nonsurgical ones in overall perception of safety and the number of events reported but underperform in the openness of communication. Four strategies, namely deepening the understanding about patient safety of supervisors, narrowing the communication gap within and across clinical units, recruiting more workers, and employing the event reporting system and building a nonpunitive culture, are recommended to improve patient safety in surgical units in the context of 1 hospital.

A Clinical Tool for Reducing Central Nervous System Depression among Neonates Exposed to Codeine through Breast Milk

PubMed Central

Kelly, Lauren E.; Chaudhry, Shahnaz A.; Rieder, Michael J.; ‘t Jong, Geert; Moretti, Myla E.; Lausman, Andrea; Ross, Colin; Berger, Howard; Carleton, Bruce; Hayden, Michael R.; Madadi, Parvaz; Koren, Gideon

2013-01-01

Background Neonates are commonly exposed to maternal codeine through breast milk. Central Nervous System (CNS) depression has been reported in up to 24% of nurslings following codeine exposure. In 2009, we developed guidelines to improve the safety of codeine use during breastfeeding based on previously established pharmacogenetic and clinical risk factors. The primary objective of this study was to prospectively evaluate the effectiveness of these guidelines in ensuring neonatal safety. Methods and Findings Women taking codeine for pain following caesarean section were given safety guidelines, including advice to use the lowest codeine dose for no longer than four days and to switch to a non-opioid when possible. Mothers provided a saliva sample for analysis of genes involved in opioid disposition, metabolism and response. A total of 238 consenting women participated. Neonatal sedation was reported in 2.1% (5/238) of breastfeeding women taking codeine according to our safety guidelines. This rate was eight fold lower than that reported in previous prospective studies. Women reporting sedated infants were taking codeine for a significantly longer period of time (4.80±2.59 days vs. 2.52±1.58 days, p = 0.0018). While following the codeine safety guidelines, mothers were less likely to supplement with formula, reported lower rates of sedation in themselves and breastfed more frequently throughout the day when compared to previously reported rates. Genotyping analysis of cytochrome p450 2D6 (CYP2D6), uridine-diphosphate glucuronosyltransferase (UGT) 2B7, p-glycoprotein (ABCB1), the mu-opioid receptor (OPRM1) and catechol-o-demethyltransferase (COMT) did not predict codeine response in breastfeeding mother/infant pairs when following the safety guidelines. Conclusions The only cases of CNS depression occurred when the length of codeine use exceeded the guideline recommendations. Neonatal safety of codeine can be improved using evidence-based guidelines, even in those deemed by genetics to be at high risk for toxicity. PMID:23922910

Safety evaluation report on Tennessee Valley Authority: Browns Ferry nuclear performance plan

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

Not Available

1989-10-01

This safety evaluation report (SER) on the information submitted by the Tennessee Valley Authority (TVA) in its Nuclear Performance Plan, through Revision 2, for the Browns Ferry Nuclear Plant and in supporting documents has been prepared by the US Nuclear Regulatory commission staff. The Browns Ferry Nuclear Plant consists of three boiling-water reactors at a site in Limestone County, Alabama. The plan addresses the plant-specific concerns requiring resolution before the startup of Unit 2. The staff will inspect implementation of those TVA programs that address these concerns. Where systems are common to Units 1 and 2 or to Units 2more » and 3, the staff safety evaluations of those systems are included herein. 85 refs.« less

Current status of environmental, health, and safety issues of lithium ion electric vehicle batteries

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

Vimmerstedt, L.J.; Ring, S.; Hammel, C.J.

The lithium ion system considered in this report uses lithium intercalation compounds as both positive and negative electrodes and has an organic liquid electrolyte. Oxides of nickel, cobalt, and manganese are used in the positive electrode, and carbon is used in the negative electrode. This report presents health and safety issues, environmental issues, and shipping requirements for lithium ion electric vehicle (EV) batteries. A lithium-based electrochemical system can, in theory, achieve higher energy density than systems using other elements. The lithium ion system is less reactive and more reliable than present lithium metal systems and has possible performance advantages overmore » some lithium solid polymer electrolyte batteries. However, the possibility of electrolyte spills could be a disadvantage of a liquid electrolyte system compared to a solid electrolyte. The lithium ion system is a developing technology, so there is some uncertainty regarding which materials will be used in an EV-sized battery. This report reviews the materials presented in the open literature within the context of health and safety issues, considering intrinsic material hazards, mitigation of material hazards, and safety testing. Some possible lithium ion battery materials are toxic, carcinogenic, or could undergo chemical reactions that produce hazardous heat or gases. Toxic materials include lithium compounds, nickel compounds, arsenic compounds, and dimethoxyethane. Carcinogenic materials include nickel compounds, arsenic compounds, and (possibly) cobalt compounds, copper, and polypropylene. Lithiated negative electrode materials could be reactive. However, because information about the exact compounds that will be used in future batteries is proprietary, ongoing research will determine which specific hazards will apply.« less

Design and application of a tool for structuring, capitalizing and making more accessible information and lessons learned from accidents involving machinery.

PubMed

Sadeghi, Samira; Sadeghi, Leyla; Tricot, Nicolas; Mathieu, Luc

2017-12-01

Accident reports are published in order to communicate the information and lessons learned from accidents. An efficient accident recording and analysis system is a necessary step towards improvement of safety. However, currently there is a shortage of efficient tools to support such recording and analysis. In this study we introduce a flexible and customizable tool that allows structuring and analysis of this information. This tool has been implemented under TEEXMA®. We named our prototype TEEXMA®SAFETY. This tool provides an information management system to facilitate data collection, organization, query, analysis and reporting of accidents. A predefined information retrieval module provides ready access to data which allows the user to quickly identify the possible hazards for specific machines and provides information on the source of hazards. The main target audience for this tool includes safety personnel, accident reporters and designers. The proposed data model has been developed by analyzing different accident reports.

Accidents and Apathy: The Construction of the 'Robens Philosophy' of Occupational Safety and Health Regulation in Britain, 1961-1974.

PubMed

Sirrs, Christopher

2016-02-01

The 1972 Robens Report is widely regarded to have provided the underlying rationale for the 'modern' system of occupational health and safety regulation in Britain, embodied in the Health and Safety at Work Act (HSW Act) 1974. The HSW Act advanced a new, more flexible system of regulation, premised on the ideal of self-regulation by industry. This article advances a more nuanced historical understanding of the Report and its ethos-the 'Robens philosophy'-than hitherto developed, situating its assumptions about accidents, regulation and the role of the state in the social, economic and political context of Britain in the 1960s and early 1970s. Highlighting the interaction between these trends and long-established regulatory practices, the article argues that the turn to 'self-regulation' heralded by the Robens Report was highly convincing from a political and regulatory perspective at the time it was promulgated.

John M. Eisenberg Patient Safety Awards. System innovation: Veterans Health Administration National Center for Patient Safety.

PubMed

Heget, Jeffrey R; Bagian, James P; Lee, Caryl Z; Gosbee, John W

2002-12-01

In 1998 the Veterans Health Administration (VHA) created the National Center for Patient Safety (NCPS) to lead the effort to reduce adverse events and close calls systemwide. NCPS's aim is to foster a culture of safety in the Department of Veterans Affairs (VA) by developing and providing patient safety programs and delivering standardized tools, methods, and initiatives to the 163 VA facilities. To create a system-oriented approach to patient safety, NCPS looked for models in fields such as aviation, nuclear power, human factors, and safety engineering. Core concepts included a non-punitive approach to patient safety activities that emphasizes systems-based learning, the active seeking out of close calls, which are viewed as opportunities for learning and investigation, and the use of interdisciplinary teams to investigate close calls and adverse events through a root cause analysis (RCA) process. Participation by VA facilities and networks was voluntary. NCPS has always aimed to develop a program that would be applicable both within the VA and beyond. NCPS's full patient safety program was tested and implemented throughout the VA system from November 1999 to August 2000. Program components included an RCA system for use by caregivers at the front line, a system for the aggregate review of RCA results, information systems software, alerts and advisories, and cognitive acids. Following program implementation, NCPS saw a 900-fold increase in reporting of close calls of high-priority events, reflecting the level of commitment to the program by VHA leaders and staff.

Benchmarking Global Food Safety Performances: The Era of Risk Intelligence.

PubMed

Valleé, Jean-Charles Le; Charlebois, Sylvain

2015-10-01

Food safety data segmentation and limitations hamper the world's ability to select, build up, monitor, and evaluate food safety performance. Currently, there is no metric that captures the entire food safety system, and performance data are not collected strategically on a global scale. Therefore, food safety benchmarking is essential not only to help monitor ongoing performance but also to inform continued food safety system design, adoption, and implementation toward more efficient and effective food safety preparedness, responsiveness, and accountability. This comparative study identifies and evaluates common elements among global food safety systems. It provides an overall world ranking of food safety performance for 17 Organisation for Economic Co-Operation and Development (OECD) countries, illustrated by 10 indicators organized across three food safety risk governance domains: risk assessment (chemical risks, microbial risks, and national reporting on food consumption), risk management (national food safety capacities, food recalls, food traceability, and radionuclides standards), and risk communication (allergenic risks, labeling, and public trust). Results show all countries have very high food safety standards, but Canada and Ireland, followed by France, earned excellent grades relative to their peers. However, any subsequent global ranking study should consider the development of survey instruments to gather adequate and comparable national evidence on food safety.

Patient safety climate (PSC) perceptions of frontline staff in acute care hospitals: examining the role of ease of reporting, unit norms of openness, and participative leadership.

PubMed

Zaheer, Shahram; Ginsburg, Liane; Chuang, You-Ta; Grace, Sherry L

2015-01-01

Increased awareness regarding the importance of patient safety issues has led to the proliferation of theoretical conceptualizations, frameworks, and articles that apply safety experiences from high-reliability industries to medical settings. However, empirical research on patient safety and patient safety climate in medical settings still lags far behind the theoretical literature on these topics. The broader organizational literature suggests that ease of reporting, unit norms of openness, and participative leadership might be important variables for improving patient safety. The aim of this empirical study is to examine in detail how these three variables influence frontline staff perceptions of patient safety climate within health care organizations. A cross-sectional study design was used. Data were collected using a questionnaire composed of previously validated scales. The results of the study show that ease of reporting, unit norms of openness, and participative leadership are positively related to staff perceptions of patient safety climate. Health care management needs to involve frontline staff during the development and implementation stages of an error reporting system to ensure staff perceive error reporting to be easy and efficient. Senior and supervisory leaders at health care organizations must be provided with learning opportunities to improve their participative leadership skills so they can better integrate frontline staff ideas and concerns while making safety-related decisions. Finally, health care management must ensure that frontline staff are able to freely communicate safety concerns without fear of being punished or ridiculed by others.

Hydrogen Safety Issues Compared to Safety Issues with Methane and Propane

NASA Astrophysics Data System (ADS)

Green, M. A.

2006-04-01

The hydrogen economy is not possible if the safety standards currently applied to liquid hydrogen and hydrogen gas by many laboratories are applied to devices that use either liquid or gaseous hydrogen. Methane and propane are commonly used by ordinary people without the special training. This report asks, "How is hydrogen different from flammable gasses that are commonly being used all over the world?" This report compares the properties of hydrogen, methane and propane and how these properties may relate to safety when they are used in both the liquid and gaseous state. Through such an analysis, sensible safety standards for the large-scale (or even small-scale) use of liquid and gaseous hydrogen systems can be developed. This paper is meant to promote discussion of issues related to hydrogen safety so that engineers designing equipment can factor sensible safety standards into their designs.

Hydrogen Safety Issues Compared to Safety Issues with Methane andPropane

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

Green, Michael A.

The hydrogen economy is not possible if the safety standards currently applied to liquid hydrogen and hydrogen gas by many laboratories are applied to devices that use either liquid or gaseous hydrogen. Methane and propane are commonly used by ordinary people without the special training. This report asks, 'How is hydrogen different from flammable gasses that are commonly being used all over the world?' This report compares the properties of hydrogen, methane and propane and how these properties may relate to safety when they are used in both the liquid and gaseous state. Through such an analysis, sensible safety standardsmore » for the large-scale (or even small-scale) use of liquid and gaseous hydrogen systems can be developed. This paper is meant to promote discussion of issues related to hydrogen safety so that engineers designing equipment can factor sensible safety standards into their designs.« less

76 FR 49532 - Federal Motor Vehicle Safety Standards; Electronic Stability Control; Technical Report on the...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-10

... Effectiveness of Electronic Stability Control Systems for Cars and LTVs AGENCY: National Highway Traffic Safety... effectiveness of electronic stability control (ESC) for passenger cars and LTVs (light trucks and vans). Safety... probability that a vehicle would be involved in a fatal crash. For passenger cars, the reductions are 5...

42 CFR 3.102 - Process and requirements for initial and continued listing of PSOs.

Code of Federal Regulations, 2014 CFR

2014-10-01

... improve patient safety and the quality of health care delivery. (B) The PSO must have appropriately... patient safety reporting system to which health care providers (other than members of the entity's... activities, defined in § 3.20. With respect to paragraphs (5) and (6) in the definition of patient safety...

42 CFR 3.102 - Process and requirements for initial and continued listing of PSOs.

Code of Federal Regulations, 2013 CFR

2013-10-01

... improve patient safety and the quality of health care delivery. (B) The PSO must have appropriately... patient safety reporting system to which health care providers (other than members of the entity's... activities, defined in § 3.20. With respect to paragraphs (5) and (6) in the definition of patient safety...

42 CFR 3.102 - Process and requirements for initial and continued listing of PSOs.

Code of Federal Regulations, 2012 CFR

2012-10-01

... improve patient safety and the quality of health care delivery. (B) The PSO must have appropriately... patient safety reporting system to which health care providers (other than members of the entity's... activities, defined in § 3.20. With respect to paragraphs (5) and (6) in the definition of patient safety...

Emergency and backup power supplies at Department of Energy facilities: Augmented Evaluation Team -- Final report

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

Not Available

This report documents the results of the Defense Programs (DP) Augmented Evaluation Team (AET) review of emergency and backup power supplies (i.e., generator, uninterruptible power supply, and battery systems) at DP facilities. The review was conducted in response to concerns expressed by former Secretary of Energy James D. Watkins over the number of incidents where backup power sources failed to provide electrical power during tests or actual demands. The AET conducted a series of on-site reviews for the purpose of understanding the design, operation, maintenance, and safety significance of emergency and backup power (E&BP) supplies. The AET found that themore » quality of programs related to maintenance of backup power systems varies greatly among the sites visited, and often among facilities at the same site. No major safety issues were identified. However, there are areas where the AET believes the reliability of emergency and backup power systems can and should be improved. Recommendations for improving the performance of E&BP systems are provided in this report. The report also discusses progress made by Management and Operating (M&O) contractors to improve the reliability of backup sources used in safety significant applications. One area that requires further attention is the analysis and understanding of the safety implications of backup power equipment. This understanding is needed for proper graded-approach implementation of Department of Energy (DOE) Orders, and to help ensure that equipment important to the safety of DOE workers, the public, and the environment is identified, classified, recognized, and treated as such by designers, users, and maintainers. Another area considered important for improving E&BP system performance is the assignment of overall ownership responsibility and authority for ensuring that E&BP equipment performs adequately and that reliability and availability are maintained at acceptable levels.« less

Integrating natural language processing expertise with patient safety event review committees to improve the analysis of medication events.

PubMed

Fong, Allan; Harriott, Nicole; Walters, Donna M; Foley, Hanan; Morrissey, Richard; Ratwani, Raj R

2017-08-01

Many healthcare providers have implemented patient safety event reporting systems to better understand and improve patient safety. Reviewing and analyzing these reports is often time consuming and resource intensive because of both the quantity of reports and length of free-text descriptions in the reports. Natural language processing (NLP) experts collaborated with clinical experts on a patient safety committee to assist in the identification and analysis of medication related patient safety events. Different NLP algorithmic approaches were developed to identify four types of medication related patient safety events and the models were compared. Well performing NLP models were generated to categorize medication related events into pharmacy delivery delays, dispensing errors, Pyxis discrepancies, and prescriber errors with receiver operating characteristic areas under the curve of 0.96, 0.87, 0.96, and 0.81 respectively. We also found that modeling the brief without the resolution text generally improved model performance. These models were integrated into a dashboard visualization to support the patient safety committee review process. We demonstrate the capabilities of various NLP models and the use of two text inclusion strategies at categorizing medication related patient safety events. The NLP models and visualization could be used to improve the efficiency of patient safety event data review and analysis. Copyright © 2017 Elsevier B.V. All rights reserved.

Establishing a publicly available national database of US news articles reporting agriculture-related injuries and fatalities.

PubMed

Weichelt, Bryan; Salzwedel, Marsha; Heiberger, Scott; Lee, Barbara C

2018-05-22

The AgInjuryNews system and dataset are a news report repository and information source for agricultural safety professionals, policymakers, journalists, and law enforcement officials. AgInjuryNews was designed as a primary storage and retrieval system that allows users to: identify agricultural injury/fatality events; identify injury agents and emerging issues; provide safety messages for media in anticipation of trends; and raise awareness and knowledge of agricultural injuries and prevention strategies. Data are primarily collected through Google Alerts and a digital media subscription service. Articles are screened, reviewed, coded, and entered into the system. As of January 1, 2018, the system contained 3028 unique incidents. Of those, 650 involved youth, and 1807 were fatalities. The system also had registered 329 users from 39 countries. AgInjuryNews combines injury reports into one dataset and may be the most current and comprehensive publicly available collection of news reports on agricultural injuries and deaths. © 2018 Wiley Periodicals, Inc.

Impact of an electronic alert notification system embedded in radiologists' workflow on closed-loop communication of critical results: a time series analysis.

PubMed

Lacson, Ronilda; O'Connor, Stacy D; Sahni, V Anik; Roy, Christopher; Dalal, Anuj; Desai, Sonali; Khorasani, Ramin

2016-07-01

Optimal critical test result communication is a Joint Commission national patient safety goal and requires documentation of closed-loop communication among care providers in the medical record. Electronic alert notification systems can facilitate an auditable process for creating alerts for transmission and acknowledgement of critical test results. We evaluated the impact of a patient safety initiative with an alert notification system on reducing critical results lacking documented communication, and assessed potential overuse of the alerting system for communicating results. We implemented an alert notification system-Alert Notification of Critical Results (ANCR)-in January 2010. We reviewed radiology reports finalised in 2009-2014 which lacked documented communication between the radiologist and another care provider, and assessed the impact of ANCR on the proportion of such reports with critical findings, using trend analysis over 10 semiannual time periods. To evaluate potential overuse of ANCR, we assessed the proportion of reports with non-critical results among provider-communicated reports. The proportion of reports with critical results among reports without documented communication decreased significantly over 4 years (2009-2014) from 0.19 to 0.05 (p<0.0001, Cochran-Armitage trend test). The proportion of provider-communicated reports with non-critical results remained unchanged over time before and after ANCR implementation (0.20 to 0.15, p=0.45, Cochran-Armitage trend test). A patient safety initiative with an alert notification system reduced the proportion of critical results among reports lacking documented communication between care providers. We observed no change in documented communication of non-critical results, suggesting the system did not promote overuse. Future studies are needed to evaluate whether such systems prevent subsequent patient harm. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Conceptual design study of Fusion Experimental Reactor (FY86 FER): Safety

NASA Astrophysics Data System (ADS)

Seki, Yasushi; Iida, Hiromasa; Honda, Tsutomu

1987-08-01

This report describes the study on safety for FER (Fusion Experimental Reactor) which has been designed as a next step machine to the JT-60. Though the final purpose of this study is to have an image of design base accident, maximum credible accident and to assess their risk or probability, etc., as FER plant system, the emphasis of this years study is placed on fuel-gas circulation system where the tritium inventory is maximum. The report consists of two chapters. The first chapter summarizes the FER system and describes FMEA (Failure Mode and Effect Analysis) and related accident progression sequence for FER plant system as a whole. The second chapter of this report is focused on fuel-gas circulation system including purification, isotope separation and storage. Probability of risk is assessed by the probabilistic risk analysis (PRA) procedure based on FMEA, ETA and FTA.

33 CFR 169.125 - What classes of ships are required to make reports?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false What classes of ships are required to make reports? 169.125 Section 169.125 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY SHIP REPORTING SYSTEMS Establishment of Two Mandatory Ship Reporting Systems for the...

33 CFR 169.130 - When are ships required to make reports?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false When are ships required to make reports? 169.130 Section 169.130 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY SHIP REPORTING SYSTEMS Establishment of Two Mandatory Ship Reporting Systems for the Protection of...

Investigations of plastic composite materials for highway safety structures

DOT National Transportation Integrated Search

1998-08-01

This report presents a basic overview and assessment of different concepts and technologies of using polymer composites in structures generally used for highway safety. The structural systems included a highway barrier guardrail with its posts and bl...

76 FR 65778 - Pipeline Safety: Information Collection Activities

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-24

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No...: 12,120. Frequency of Collection: On occasion. 2. Title: Recordkeeping for Natural Gas Pipeline... investigating incidents. Affected Public: Operators of natural gas pipeline systems. Annual Reporting and...

Specific features of medicines safety and pharmacovigilance in Africa

PubMed Central

Pal, Shanthi N.; Olsson, Sten; Dodoo, Alexander; Bencheikh, Rachida Soulayami

2012-01-01

The thalidomide tragedy in the late 1950s and early 1960s served as a wakeup call and raised questions about the safety of medicinal products. The developed countries rose to the challenge putting in place systems to ensure the safety of medicines. However, this was not the case for low-resource settings because of prevailing factors inherent in them. This paper reviews some of these features and the current status of pharmacovigilance in Africa. The health systems in most of the 54 countries of Africa are essentially weak, lacking in basic infrastructure, personnel, equipment and facilities. The recent mass deployment of medicines to address diseases of public health significance in Africa poses additional challenges to the health system with notable safety concerns. Other safety issues of note include substandard and counterfeit medicines, medication errors and quality of medicinal products. The first national pharmacovigilance centres established in Africa with membership of the World Health Organization (WHO) international drug monitoring programme were in Morocco and South Africa in 1992. Of the 104 full member countries in the programme, there are now 24 African countries with a further nine countries as associate members. The pharmacovigilance systems operational in African countries are based essentially on spontaneous reporting facilitated by the introduction of the new tool Vigiflow. The individual case safety reports committed to the WHO global database (Vigibase) attest to the growth of pharmacovigilance in Africa with the number of reports rising from 2695 in 2000 to over 25,000 in 2010. There is need to engage the various identified challenges of the weak pharmacovigilance systems in the African setting and to focus efforts on how to provide resources, infrastructure and expertise. Raising the level of awareness among healthcare providers, developing training curricula for healthcare professionals, provisions for paediatric and geriatric pharmacovigilance, engaging the pharmaceutical industries as well as those for herbal remedies are of primary concern. PMID:25083223

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

PubMed

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

2006-11-27

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

Preliminary design review report - sludge offload system

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

Mcwethy, L.M. Westinghouse Hanford

1996-06-05

This report documents the conceptual design review of the sludge offload system for the Spent Nuclear Fuel Project. The design description, drawings, available analysis, and safety analysis were reviewed by a peer group. The design review comments and resolutions are documented.

Leveraging Event Reporting Through Knowledge Support: A Knowledge-Based Approach to Promoting Patient Fall Prevention.

PubMed

Yao, Bin; Kang, Hong; Miao, Qi; Zhou, Sicheng; Liang, Chen; Gong, Yang

2017-01-01

Patient falls are a common safety event type that impairs the healthcare quality. Strategies including solution tools and reporting systems for preventing patient falls have been developed and implemented in the U.S. However, the current strategies do not include timely knowledge support, which is in great need in bridging the gap between reporting and learning. In this study, we constructed a knowledge base of fall events by combining expert-reviewed fall prevention solutions and then integrating them into a reporting system. The knowledge base enables timely and tailored knowledge support and thus will serve as a prevailing fall prevention tool. This effort holds promise in making knowledge acquisition and management a routine process for enhancing the reporting and understanding of patient safety events.

Does lean management improve patient safety culture? An extensive evaluation of safety culture in a radiotherapy institute.

PubMed

Simons, Pascale A M; Houben, Ruud; Vlayen, Annemie; Hellings, Johan; Pijls-Johannesma, Madelon; Marneffe, Wim; Vandijck, Dominique

2015-02-01

The importance of a safety culture to maximize safety is no longer questioned. However, achieving sustainable culture improvements are less evident. Evidence is growing for a multifaceted approach, where multiple safety interventions are combined. Lean management is such an integral approach to improve safety, quality and efficiency and therefore, could be expected to improve the safety culture. This paper presents the effects of lean management activities on the patient safety culture in a radiotherapy institute. Patient safety culture was evaluated over a three year period using triangulation of methodologies. Two surveys were distributed three times, workshops were performed twice, data from an incident reporting system (IRS) was monitored and results were explored using structured interviews with professionals. Averages, chi-square, logistical and multi-level regression were used for analysis. The workshops showed no changes in safety culture, whereas the surveys showed improvements on six out of twelve dimensions of safety climate. The intention to report incidents not reaching patient-level decreased in accordance with the decreasing number of reports in the IRS. However, the intention to take action in order to prevent future incidents improved (factorial survey presented β: 1.19 with p: 0.01). Due to increased problem solving and improvements in equipment, the number of incidents decreased. Although the intention to report incidents not reaching patient-level decreased, employees experienced sustained safety awareness and an increased intention to structurally improve. The patient safety culture improved due to the lean activities combined with an organizational restructure, and actual patient safety outcomes might have improved as well. Copyright © 2014 Elsevier Ltd. All rights reserved.

Applications of teleworking based on a study of disabled workers.

PubMed

Nishina, Masahisa

2010-01-01

There are many problems involved in maintaining safety for different kinds of handicapped workers. One of the biggest problems is how these persons can commute to their workplace safely. One possible solution to this problem is using a teleworking system. This system is also good for saving money and the environment because it does not require commuting. The teleworking system has many other merits including enhanced safety and can be applied to many other aspects of life. For example, it can be used for the care of solitary elderly persons, watching small children in a two-income family, and working or providing medical treatment in remote and underpopulated areas. However, these applications are not yet common, and few reports have dealt with such merits. The case studies of disabled workers using teleworking reported here demonstrate the safety, financial and environmental benefits of teleworking.

Ending on a positive: Examining the role of safety leadership decisions, behaviours and actions in a safety critical situation.

PubMed

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

2018-01-01

Safety leadership is an important factor in supporting safe performance in the workplace. The present case study examined the role of safety leadership during the Bingham Canyon Mine high-wall failure, a significant mining incident in which no fatalities or injuries were incurred. The Critical Decision Method (CDM) was used in conjunction with a self-reporting approach to examine safety leadership in terms of decisions, behaviours and actions that contributed to the incidents' safe outcome. Mapping the analysis onto Rasmussen's Risk Management Framework (Rasmussen, 1997), the findings demonstrate clear links between safety leadership decisions, and emergent behaviours and actions across the work system. Communication and engagement based decisions featured most prominently, and were linked to different leadership practices across the work system. Further, a core sub-set of CDM decision elements were linked to the open flow and exchange of information across the work system, which was critical to supporting the safe outcome. The findings provide practical implications for the development of safety leadership capability to support safety within the mining industry. Copyright © 2017 Elsevier Ltd. All rights reserved.

WE-G-BRA-01: Patient Safety and Treatment Quality Improvement Through Incident Learning: Experience of a Non-Academic Proton Therapy Center

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

Zheng, Y; Johnson, R; Zhao, L

2015-06-15

Purpose: Incident learning has been proven to improve patient safety and treatment quality in conventional radiation therapy. However, its application in proton therapy has not been reported yet to our knowledge. In this study, we report our experience in developing and implementation of an in-house incident learning system. Methods: An incident learning system was developed based on published principles and tailored for our clinical practice and available resource about 18 months ago. The system includes four layers of error detection and report: 1) dosimetry peer review; 2) physicist plan quality assurance (QA); 3) treatment delivery issue on call and record;more » and 4) other incident report. The first two layers of QA and report were mandatory for each treatment plan through easy-to-use spreadsheets that are only accessible by the dosimetry and physicist departments. The treatment delivery issues were recorded case by case by the on call physicist. All other incidents were reported through an online incident report system, which can be anonymous. The incident report includes near misses on planning and delivery, process deviation, machine issues, work flow and documentation. Periodic incident reviews were performed. Results: In total, about 116 errors were reported through dosimetry review, 137 errors through plan QA, 83 treatment issues through physics on call record, and 30 through the online incident report. Only 8 incidents (2.2%) were considered to have a clinical impact to patients, and the rest of errors were either detected before reaching patients or had negligible dosimetric impact (<5% dose variance). Personnel training & process improvements were implemented upon periodic incident review. Conclusion: An incident learning system can be helpful in personnel training, error reduction, and patient safety and treatment quality improvement. The system needs to be catered for each clinic’s practice and available resources. Incident and knowledge sharing among proton centers are encouraged.« less

Transportation infrastructure : states' implementation of transportation management systems

DOT National Transportation Integrated Search

1997-01-13

This report focuses on the U.S. General Accounting Office's ISTEA update of the states' implementation of pavement management systems, bridges, highway safety, congestion management systems, public transportation, and intermodal management systems. A...

Demonstration of a Safety Analysis on a Complex System

NASA Technical Reports Server (NTRS)

Leveson, Nancy; Alfaro, Liliana; Alvarado, Christine; Brown, Molly; Hunt, Earl B.; Jaffe, Matt; Joslyn, Susan; Pinnell, Denise; Reese, Jon; Samarziya, Jeffrey;

Aviation Weather Information Requirements Study

NASA Technical Reports Server (NTRS)

Keel, Byron M.; Stancil, Charles E.; Eckert, Clifford A.; Brown, Susan M.; Gimmestad, Gary G.; Richards, Mark A.; Schaffner, Philip R. (Technical Monitor)

2000-01-01

The Aviation Safety Program (AvSP) has as its goal an improvement in aviation safety by a factor of 5 over the next 10 years and a factor of 10 over the next 20 years. Since weather has a big impact on aviation safety and is associated with 30% of all aviation accidents, Weather Accident Prevention (WxAP) is a major element under this program. The Aviation Weather Information (AWIN) Distribution and Presentation project is one of three projects under this element. This report contains the findings of a study conducted by the Georgia Tech Research Institute (GTRI) under the Enhanced Weather Products effort, which is a task under AWIN. The study examines current aviation weather products and there application. The study goes on to identify deficiencies in the current system and to define requirements for aviation weather products that would lead to an increase in safety. The study also provides an overview the current set of sensors applied to the collection of aviation weather information. New, modified, or fused sensor systems are identified which could be applied in improving the current set of weather products and in addressing the deficiencies defined in the report. In addition, the study addresses and recommends possible sensors for inclusion in an electronic pilot reporting (EPIREP) system.

Manned space flight nuclear system safety. Volume 3: Reactor system preliminary nuclear safety analysis. Part 1: Reference Design Document (RDD)

NASA Technical Reports Server (NTRS)

1972-01-01

The Reference Design Document, of the Preliminary Safety Analysis Report (PSAR) - Reactor System provides the basic design and operations data used in the nuclear safety analysis of the Rector Power Module as applied to a Space Base program. A description of the power module systems, facilities, launch vehicle and mission operations, as defined in NASA Phase A Space Base studies is included. Each of two Zirconium Hydride Reactor Brayton power modules provides 50 kWe for the nominal 50 man Space Base. The INT-21 is the prime launch vehicle. Resupply to the 500 km orbit over the ten year mission is provided by the Space Shuttle. At the end of the power module lifetime (nominally five years), a reactor disposal system is deployed for boost into a 990 km high altitude (long decay time) earth orbit.

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

PubMed Central

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

2014-01-01

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

Monitoring drug safety in Astrakhan, Russia.

PubMed

Kirilochev, O O; Dorfman, I P; Umerova, A R

2015-01-01

The problem of drug safety will never disappear as new drugs are delivered in increasing numbers. They have high biological activity and adverse drug reactions (ADR) [1]. Currently, adverse drug reactions are the fourth leading cause of death for patients.There are databases of ADRs (Vigibase, Eudravigilance), but we know that ADR manifestations may vary in different countries and regions, due to the demographic, genetic characteristics of the population and the quality of manufactured drugs [2]. In this regard, the study of the ADR at the regional level is very relevant. We aimed to optimize the work on monitoring drug safety in Astrakhan region through pharmacoepidemiological research and development of computer database for analysis of information coming to the center for drug safety monitoring (CDSM). 1. To study the rates of ADR reporting and the structure in the Astrakhan region at the regional center for drug safety monitoring.2. To analyze the outcomes of registered adverse drug reactions.3. To determine the causality of adverse drug reactions.4. To identify reports on the ineffectiveness of drugs.5. To analyze the rates and structure of ADR reporting for drugs prescribed off-label. We studied spontaneous adverse event reporting. The adverse event reports received by the regional CDSM for the period of 2010 to 2014 was analyzed. The groups of drugs were categorized according by Anatomical Therapeutic Chemical classification system. The data were analyzed using Microsoft Office Excel. The likelihood of whether an ADR was actually due to the drugs was assessed with the Naranjo algorithm. The analysis of the results showed that the establishment of the CDSM in September 2010, contributed to improvement of drug safety monitoring in health facilities of the region. Noteworthy was the increasing the number of adverse event reports in 2011 and 2012, compared with the beginning of the year 2010, when the CDSM was not yet functioning.The decrease of adverse event reporting in 2013 and 2014 was due to the fact that doctors in the region had access to better ADR drug information. Along with the increasing number of adverse event reporting we also noted the increase in the number of health facilities that monitored drug safety. The number of health facilities that reported, doubled from 2010 to 2014. We observed the increase in the number of adverse event reports submitted by pharmaceutical companies. General anti-infective drugs for systemic use (class J) were the most common cause of all registered ADRs (44%). Drugs for treatment of tuberculosis (group J04A) were the cause of adverse drug reactions in 34% of reports. ADRs associated with drugs used for treating diseases of cardiovascular system accounted for 16% of case-reports; drugs belonging to the group of Alimentary tract and metabolism (class A) and to the group of Nervous System (class A) were reported to cause ADRs in 10% of cases each. Type A adverse drug reactions, which are usually a consequence of a drug's primary pharmacological effect, were detected in 45% of cases. These reactions were often registered for drugs affecting cardiovascular system (class C), nervous system (class N), dlood and blood forming organs (class B). Type B ADRs were reported in 54% of cases. These were "idiosyncratic" reactions, which could not be predicted on the basis of the drug's main pharmacological action, were not dose-related and were severe [3]. The most frequent cause of type B adverse drug reactions was the General anti-infective medicines for systemic use (Class J). The fatality rate associated with ADRs was 0.3%. Type A adverse drug reactions resulted in death in 38% of cases. Type B ADR (anaphylactic shock) accounted for 62% of the patient's deaths. The Naranjo scale determined the causality of ADRs. The "definite" ADRs were detected in 14% of reports, "probable" - in 47%, and "possible" - in 39% of cases. The rate of reporting associated with ineffectiveness of drugs amounted to 1%. Most often the lack of therapeutic effect was reported in patients receiving drugs of class C (Cardiovascular system, 31% of all cases of inefficiency of drugs). These drugs were used in accordance with their official instructions for use. The proportion of ADR reports for drugs prescribed off-label was 1.4%. The results substantiate the need to continue drug safety monitoring in the Astrakhan region. We plan to further improve the software for ADR analysis.

Active SMS-based influenza vaccine safety surveillance in Australian children.

PubMed

Pillsbury, Alexis; Quinn, Helen; Cashman, Patrick; Leeb, Alan; Macartney, Kristine

2017-12-18

Australia's novel, active surveillance system, AusVaxSafety, monitors the post-market safety of vaccines in near real time. We analysed cumulative surveillance data for children aged 6 months to 4 years who received seasonal influenza vaccine in 2015 and/or 2016 to determine: adverse event following immunisation (AEFI) rates by vaccine brand, age and concomitant vaccine administration. Parent/carer reports of AEFI occurring within 3 days of their child receiving an influenza vaccine in sentinel immunisation clinics were solicited by Short Message Service (SMS) and/or email-based survey. Retrospective data from 2 years were combined to examine specific AEFI rates, particularly fever and medical attendance as a proxy for serious adverse events (SAE), with and without concomitant vaccine administration. As trivalent influenza vaccines (TIV) were funded in Australia's National Immunisation Program (NIP) in 2015 and quadrivalent (QIV) in 2016, respectively, we compared their safety profiles. 7402 children were included. Data were reported weekly through each vaccination season; no safety signals or excess of adverse events were detected. More children who received a concomitant vaccine had fever (7.5% versus 2.8%; p < .001). Meningococcal B vaccine was associated with the highest increase in AEFI rates among children receiving a specified concomitant vaccine: 30.3% reported an AEFI compared with 7.3% who received an influenza vaccine alone (p < .001). Reported fever was strongly associated with medical attendance (OR: 42.6; 95% Confidence Interval (CI): 25.6-71.0). TIV and QIV safety profiles included low and expected AEFI rates (fever: 4.3% for TIV compared with 3.2% for QIV (p = .015); injection site reaction: 1.9% for TIV compared with 3.0% for QIV (p < .001)). There was no difference in safety profile between brands. Active participant-reported data provided timely vaccine brand-specific safety information. Our surveillance system has particular utility in monitoring the safety of influenza vaccines, given that they may vary in composition annually. Copyright © 2017 Elsevier Ltd. All rights reserved.

When bad things happen: adverse event reporting and disclosure as patient safety and risk management tools in the neonatal intensive care unit.

PubMed

Donn, Steven M; McDonnell, William M

2012-01-01

The Institute of Medicine has recommended a change in culture from "name and blame" to patient safety. This will require system redesign to identify and address errors, establish performance standards, and set safety expectations. This approach, however, is at odds with the present medical malpractice (tort) system. The current system is outcomes-based, meaning that health care providers and institutions are often sued despite providing appropriate care. Nevertheless, the focus should remain to provide the safest patient care. Effective peer review may be hindered by the present tort system. Reporting of medical errors is a key piece of peer review and education, and both anonymous reporting and confidential reporting of errors have potential disadvantages. Diagnostic and treatment errors continue to be the leading sources of allegations of malpractice in pediatrics, and the neonatal intensive care unit is uniquely vulnerable. Most errors result from systems failures rather than human error. Risk management can be an effective process to identify, evaluate, and address problems that may injure patients, lead to malpractice claims, and result in financial losses. Risk management identifies risk or potential risk, calculates the probability of an adverse event arising from a risk, estimates the impact of the adverse event, and attempts to control the risk. Implementation of a successful risk management program requires a positive attitude, sufficient knowledge base, and a commitment to improvement. Transparency in the disclosure of medical errors and a strategy of prospective risk management in dealing with medical errors may result in a substantial reduction in medical malpractice lawsuits, lower litigation costs, and a more safety-conscious environment. Thieme Medical Publishers, Inc.

Runway Safety Monitor Algorithm for Runway Incursion Detection and Alerting

NASA Technical Reports Server (NTRS)

Green, David F., Jr.; Jones, Denise R. (Technical Monitor)

2002-01-01

The Runway Safety Monitor (RSM) is an algorithm for runway incursion detection and alerting that was developed in support of NASA's Runway Incursion Prevention System (RIPS) research conducted under the NASA Aviation Safety Program's Synthetic Vision System element. The RSM algorithm provides pilots with enhanced situational awareness and warnings of runway incursions in sufficient time to take evasive action and avoid accidents during landings, takeoffs, or taxiing on the runway. The RSM currently runs as a component of the NASA Integrated Display System, an experimental avionics software system for terminal area and surface operations. However, the RSM algorithm can be implemented as a separate program to run on any aircraft with traffic data link capability. The report documents the RSM software and describes in detail how RSM performs runway incursion detection and alerting functions for NASA RIPS. The report also describes the RIPS flight tests conducted at the Dallas-Ft Worth International Airport (DFW) during September and October of 2000, and the RSM performance results and lessons learned from those flight tests.

Program strategies for increasing car seat usage in rural areas

DOT National Transportation Integrated Search

1995-03-01

Data from the Fatal Accident Reporting System (FARS) operated by the National Highway Traffic Safety Administration (NHTSA) reveal nonuse of safety restraints to be associated with most young child crash fatalities. Rural areas of the United States a...

Analysis of existing work-zone devices with MASH safety performance criteria.

DOT National Transportation Integrated Search

2009-02-01

Crashworthy, work-zone, portable sign support systems accepted under NCHRP Report No. 350 were analyzed to : predict their safety peformance according to the TL-3 MASH evaluation criteria. An analysis was conducted to determine : which hardware param...

Warrants, design, and safety of road ranger service patrols : draft final report.

DOT National Transportation Integrated Search

2016-11-01

This research project created a decision support system for managers who must decide if a roadway warrants the addition of the Safety Service Patrol (SSP). Meetings with Florida Department of Transportation (FDOT) service patrol program manager...

FMCSA safety program effectiveness measurement : Carrier Intervention Effectiveness Model, Version 1.1, technical report.

DOT National Transportation Integrated Search

2017-04-01

The Federal Motor Carrier Safety Administration (FMCSA), in cooperation with the John A. Volpe National Transportation Systems Center (Volpe), has developed a quantitative model to measure the effectiveness of motor carrier interventions in terms of ...

Recording devices for interconnected grade crossing and intersection signal systems : an informational report.

DOT National Transportation Integrated Search

2012-10-01

Over 15 years ago, the National Transportation Safety Board (NTSB) issued 29 recommendations : to improve safety at active controlled highway-rail grade crossings following the school buscommuter : train collision in Fox River Grove, Illinois. The ob...

Evaluation of the focused approach to pedestrian safety program

DOT National Transportation Integrated Search

2009-02-02

This report summarizes the results of an evaluation of the Federal Highway Administration (FHWA) Focused Approach to Pedestrian Safety Program. The study was done by the Volpe National Transportation Systems Center at the request of the FHWA Office o...

JPRS Report, Science & Technology, Japan, 4th Intelligent Robots Symposium, Volume 2

DTIC Science & Technology

1989-03-16

accidents caused by strikes by robots,5 a quantitative model for safety evaluation,6 and evaluations of actual systems7 in order to contribute to...Mobile Robot Position Referencing Using Map-Based Vision Systems.... 160 Safety Evaluation of Man-Robot System 171 Fuzzy Path Pattern of Automatic...camera are made after the robot stops to prevent damage from occurring through obstacle interference. The position of the camera is indicated on the

Annual report to the NASA Administrator by the Aerospace Safety Advisory Panel on the space shuttle program. Part 2: Summary of information developed in the panel's fact-finding activities

NASA Technical Reports Server (NTRS)

1976-01-01

Safety management areas of concern include the space shuttle main engine, shuttle avionics, orbiter thermal protection system, the external tank program, and the solid rocket booster program. The ground test program and ground support equipment system were reviewed. Systems integration and technical 'conscience' were of major priorities for the investigating teams.

Summary of Federal Aviation Administration Responses to National Transportation Safety Board Safety Recommendations.

DTIC Science & Technology

1981-07-01

reconsiderations, status reports, and followup actions. The NTSB system of priority classification for action provides for documented NTSB followup action for...controllers transmitted information to the flightcrew regarding the location and intensity of the thunderstorm system in the path of the flight, although other... system . Testimony given at a public hearing held in Omaha, Nebraska, during September 1980 indicated that the full extent of the area of precipitation and

33 CFR 169.130 - When are ships required to make reports?

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false When are ships required to make... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY SHIP REPORTING SYSTEMS Establishment of Two Mandatory Ship Reporting Systems for the Protection of Northern Right Whales § 169.130 When are ships required to make...

33 CFR 169.130 - When are ships required to make reports?

Code of Federal Regulations, 2014 CFR

2014-07-01

... 33 Navigation and Navigable Waters 2 2014-07-01 2014-07-01 false When are ships required to make... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY SHIP REPORTING SYSTEMS Establishment of Two Mandatory Ship Reporting Systems for the Protection of Northern Right Whales § 169.130 When are ships required to make...

33 CFR 169.130 - When are ships required to make reports?

Code of Federal Regulations, 2012 CFR

2012-07-01

... 33 Navigation and Navigable Waters 2 2012-07-01 2012-07-01 false When are ships required to make... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY SHIP REPORTING SYSTEMS Establishment of Two Mandatory Ship Reporting Systems for the Protection of Northern Right Whales § 169.130 When are ships required to make...

APT Blanket System Loss-of-Coolant Accident (LOCA) Based on Initial Conceptual Design - Case 4: External Pressurizer Surge Line Break Near Inlet Header

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

Hamm, L.L.

1998-10-07

This report is one of a series of reports documenting accident scenario simulations for the Accelerator Production of Tritium (APT) blanket heat removal systems. The simulations were performed in support of the Preliminary Safety Analysis Report (PSAR) for the APT.

APT Blanket System Loss-of-Coolant Accident (LOCA) Analysis Based on Initial Conceptual Design - Case 3: External HR Break at Pump Outlet without Pump Trip

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

Hamm, L.L.

1998-10-07

This report is one of a series of reports that document normal operation and accident simulations for the Accelerator Production of Tritium (APT) blanket heat removal (HR) system. These simulations were performed for the Preliminary Safety Analysis Report.

Human factors in aircraft incidents - Results of a 7-year study (Andre Allard Memorial Lecture)

NASA Technical Reports Server (NTRS)

Billings, C. E.; Reynard, W. D.

1984-01-01

It is pointed out that nearly all fatal aircraft accidents are preventable, and that most such accidents are due to human error. The present discussion is concerned with the results of a seven-year study of the data collected by the NASA Aviation Safety Reporting System (ASRS). The Aviation Safety Reporting System was designed to stimulate as large a flow as possible of information regarding errors and operational problems in the conduct of air operations. It was implemented in April, 1976. In the following 7.5 years, 35,000 reports have been received from pilots, controllers, and the armed forces. Human errors are found in more than 80 percent of these reports. Attention is given to the types of events reported, possible causal factors in incidents, the relationship of incidents and accidents, and sources of error in the data. ASRS reports include sufficient detail to permit authorities to institute changes in the national aviation system designed to minimize the likelihood of human error, and to insulate the system against the effects of errors.

Achievements and challenges of Space Station Freedom's safety review process

NASA Technical Reports Server (NTRS)

Robinson, David W.

1993-01-01

The most complex space vehicle in history, Space Station Freedom, is well underway to completion, and System Safety is a vital part of the program. The purpose is to summarize and illustrate the progress that over one-hundred System Safety engineers have made in identifying, documenting, and controlling the hazards inherent in the space station. To date, Space Station Freedom has been reviewed by NASA's safety panels through the first six assembly flights, when Freedom achieves a configuration known as Man Tended Capability. During the eight weeks of safety reviews spread out over a year and a half, over 200 preliminary hazard reports were presented. Along the way NASA and its contractors faced many challenges, made much progress, and even learned a few lessons.

Achievements and challenges of Space Station Freedom's safety review process

NASA Astrophysics Data System (ADS)

Robinson, David W.

1993-07-01

The most complex space vehicle in history, Space Station Freedom, is well underway to completion, and System Safety is a vital part of the program. The purpose is to summarize and illustrate the progress that over one-hundred System Safety engineers have made in identifying, documenting, and controlling the hazards inherent in the space station. To date, Space Station Freedom has been reviewed by NASA's safety panels through the first six assembly flights, when Freedom achieves a configuration known as Man Tended Capability. During the eight weeks of safety reviews spread out over a year and a half, over 200 preliminary hazard reports were presented. Along the way NASA and its contractors faced many challenges, made much progress, and even learned a few lessons.

Evaluation of roadside emergency call box technology : a summary report : technical assistance report.

DOT National Transportation Integrated Search

2003-04-01

Introduction Motorist aid call boxes are used to provide motorist assistance, improve safety, and can serve as an incident detection tool. More recently, Intelligent Transportation Systems (ITS) applications have been added to call box systems to enh...

The advancement of a new human factors report--'The Unique Report'--facilitating flight crew auditing of performance/operations as part of an airline's safety management system.

PubMed

Leva, M C; Cahill, J; Kay, A M; Losa, G; McDonald, N

2010-02-01

This paper presents the findings of research relating to the specification of a new human factors report, conducted as part of the work requirements for the Human Integration into the Lifecycle of Aviation Systems project, sponsored by the European Commission. Specifically, it describes the proposed concept for a unique report, which will form the basis for all operational and safety reports completed by flight crew. This includes all mandatory and optional reports. Critically, this form is central to the advancement of improved processes and technology tools, supporting airline performance management, safety management, organisational learning and knowledge integration/information-sharing activities. Specifically, this paper describes the background to the development of this reporting form, the logic and contents of this form and how reporting data will be made use of by airline personnel. This includes a description of the proposed intelligent planning process and the associated intelligent flight plan concept, which makes use of airline operational and safety analyses information. Primarily, this new reporting form has been developed in collaboration with a major Spanish airline. In addition, it has involved research with five other airlines. Overall, this has involved extensive field research, collaborative prototyping and evaluation of new reports/flight plan concepts and a number of evaluation activities. Participants have included both operational and management personnel, across different airline flight operations processes. Statement of Relevance: This paper presents the development of a reporting concept outlined through field research and collaborative prototyping within an airline. The resulting reporting function, embedded in the journey log compiled at the end of each flight, aims at enabling employees to audit the operations of the company they work for.

Safety and Security Interface Technology Initiative

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

Dr. Michael A. Lehto; Kevin J. Carroll; Dr. Robert Lowrie

Safety and Security Interface Technology Initiative Mr. Kevin J. Carroll Dr. Robert Lowrie, Dr. Micheal Lehto BWXT Y12 NSC Oak Ridge, TN 37831 865-576-2289/865-241-2772 carrollkj@y12.doe.gov Work Objective. Earlier this year, the Energy Facility Contractors Group (EFCOG) was asked to assist in developing options related to acceleration deployment of new security-related technologies to assist meeting design base threat (DBT) needs while also addressing the requirements of 10 CFR 830. NNSA NA-70, one of the working group participants, designated this effort the Safety and Security Interface Technology Initiative (SSIT). Relationship to Workshop Theme. “Supporting Excellence in Operations Through Safety Analysis,” (workshop theme)more » includes security and safety personnel working together to ensure effective and efficient operations. One of the specific workshop elements listed in the call for papers is “Safeguards/Security Integration with Safety.” This paper speaks directly to this theme. Description of Work. The EFCOG Safety Analysis Working Group (SAWG) and the EFCOG Security Working Group formed a core team to develop an integrated process involving both safety basis and security needs allowing achievement of the DBT objectives while ensuring safety is appropriately considered. This effort garnered significant interest, starting with a two day breakout session of 30 experts at the 2006 Safety Basis Workshop. A core team was formed, and a series of meetings were held to develop that process, including safety and security professionals, both contractor and federal personnel. A pilot exercise held at Idaho National Laboratory (INL) in mid-July 2006 was conducted as a feasibility of concept review. Work Results. The SSIT efforts resulted in a topical report transmitted from EFCOG to DOE/NNSA in August 2006. Elements of the report included: Drivers and Endstate, Control Selections Alternative Analysis Process, Terminology Crosswalk, Safety Basis/Security Documentation Integration, Configuration Control, and development of a shared ‘tool box’ of information/successes. Specific Benefits. The expectation or end state resulting from the topical report and associated implementation plan includes: (1) A recommended process for handling the documentation of the security and safety disciplines, including an appropriate change control process and participation by all stakeholders. (2) A means to package security systems with sufficient information to help expedite the flow of that system through the process. In addition, a means to share successes among sites, to include information and safety basis to the extent such information is transportable. (3) Identification of key security systems and associated essential security elements being installed and an arrangement for the sites installing these systems to host an appropriate team to review a specific system and determine what information is exportable. (4) Identification of the security systems’ essential elements and appropriate controls required for testing of these essential elements in the facility. (5) The ability to help refine and improve an agreed to control set at the manufacture stage.« less

Incident reporting in one UK accident and emergency department.

PubMed

Tighe, Catherine M; Woloshynowych, Maria; Brown, Ruth; Wears, Bob; Vincent, Charles

2006-01-01

Greater focus is needed on improving patient safety in modern healthcare systems and the first step to achieving this is to reliably identify the safety issues arising in healthcare. Research has shown the accident and emergency (A&E) department to be a particularly problematic environment where safety is a concern due to various factors, such as the range, nature and urgency of presenting conditions and the high turnover of patients. As in all healthcare environments clinical incident reporting in A&E is an important tool for detecting safety issues which can result in identifying solutions, learning from error and enhancing patient safety. This tool must be responsive and flexible to the local circumstances and work for the department to support the clinical governance agenda. In this paper, we describe the local processes for reporting and reviewing clinical incidents in one A&E department in a London teaching hospital and report recent changes to the system within the department. We used the historical data recorded on the Trust incident database as a representation of the information that would be available to the department in order to identify the high risk areas. In this paper, we evaluate the internal processes, the information available on the database and make recommendations to assist the emergency department in their internal processes. These will strengthen the internal review and staff feedback system so that the department can learn from incidents in a consistent manner. The process was reviewed by detailed examination of the centrally held electronic record (Datix database) of all incidents reported in a one year period. The nature of the incident and the level and accuracy of information provided in the incident reports was evaluated. There were positive aspects to the established system including evidence of positive changes made as a result of the reporting process, new initiatives to feedback to staff, and evolution of the programme for reporting and discussing the incidents internally. There appeared to be a mismatch between the recorded events and the category allocated to the incident in the historical record. In addition the database did not contain complete information for every incident, contributory factors were rarely recorded and relatively large numbers of incidents were recorded as "other" in the type of incident. There was also observed difficulty in updating the system as there is at least a months time lag between reporting or an incident and discussion/resolution of issues at the local departmental clinical risk management committee meetings. We used Leape's model for assessing the reporting system as a whole and found the system in the department to be relatively safe, fairly easy to use and moderately effective. Recommendations as a result of this study include the introduction of an electronic reporting system, limiting the number of staff who categorise the incidents--using clear definitions for classifications including a structured framework for contributory factors, and a process that allows incidents to be updated on the database locally after the discussion. This research may have implications for the incident reporting process in other specialities as well as in other hospitals.

Do specialty registrars change their attitudes, intentions and behaviour towards reporting incidents following a patient safety course?

PubMed Central

2010-01-01

Background Reporting incidents can contribute to safer health care, as an awareness of the weaknesses of a system could be considered as a starting point for improvements. It is believed that patient safety education for specialty registrars could improve their attitudes, intentions and behaviour towards incident reporting. The objective of this study was to examine the effect of a two-day patient safety course on the attitudes, intentions and behaviour concerning the voluntary reporting of incidents by specialty registrars. Methods A patient safety course was designed to increase specialty registrars' knowledge, attitudes and skills in order to recognize and cope with unintended events and unsafe situations at an early stage. Data were collected through an 11-item questionnaire before, immediately after and six months after the course was given. Results The response rate at all three points in time assessed was 100% (n = 33). There were significant changes in incident reporting attitudes and intentions immediately after the course, as well as during follow-up. However, no significant changes were found in incident reporting behaviour. Conclusions It is shown that patient safety education can have long-term positive effects on attitudes towards reporting incidents and the intentions of registrars. However, further efforts need to be undertaken to induce a real change in behaviour. PMID:20416053

Electronic availability of microgravity experiments safety and integration requirements documents

NASA Technical Reports Server (NTRS)

Hogan, Jean M.

1995-01-01

This follow-on to NASA Contractor Report 195447, Microgravity Experiments Safety and Integration Requirements Document Tree, provides the details for accessing the systems that contain the official, electronic versions of the documents initially researched in NASA Contractor Report 195447. The data in this report serves as a valuable information source for the NASA Lewis Research Center Project Documentation Center (PDC), as well as for all developers of space experiments. The PDC has acquired the hardware, software, ID's, and passwords necessary to access most of these systems and is now able to provide customers with current document information as well as immediate delivery of available documents in either electronic or hard copy format.

The systems approach to error reduction: factors influencing inoculation injury reporting in the operating theatre.

PubMed

Cutter, Jayne; Jordan, Sue

2013-11-01

To examine the frequency of, and factors influencing, reporting of mucocutaneous and percutaneous injuries in operating theatres. Surgeons and peri-operative nurses risk acquiring blood-borne viral infections during surgical procedures. Appropriate first-aid and prophylactic treatment after an injury can significantly reduce the risk of infection. However, studies indicate that injuries often go unreported. The 'systems approach' to error reduction relies on reporting incidents and near misses. Failure to report will compromise safety. A postal survey of all surgeons and peri-operative nurses engaged in exposure prone procedures in nine Welsh hospitals, face-to-face interviews with selected participants and telephone interviews with Infection Control Nurses. The response rate was 51.47% (315/612). Most respondents reported one or more percutaneous (183/315, 58.1%) and/or mucocutaneous injuries (68/315, 21.6%) in the 5 years preceding the study. Only 54.9% (112/204) reported every injury. Surgeons were poorer at reporting: 70/133 (52.6%) reported all or >50% of their injuries compared with 65/71 nurses (91.5%). Injuries are frequently under-reported, possibly compromising safety in operating theatres. A significant number of inoculation injuries are not reported. Factors influencing under-reporting were identified. This knowledge can assist managers in improving reporting and encouraging a robust safety culture within operating departments. © 2012 John Wiley & Sons Ltd.

Analysis of Aviation Safety Reporting System Incident Data Associated with the Technical Challenges of the Atmospheric Environment Safety Technology Project

NASA Technical Reports Server (NTRS)

Withrow, Colleen A.; Reveley, Mary S.

2014-01-01

This study analyzed aircraft incidents in the NASA Aviation Safety Reporting System (ASRS) that apply to two of the three technical challenges (TCs) in NASA's Aviation Safety Program's Atmospheric Environment Safety Technology Project. The aircraft incidents are related to airframe icing and atmospheric hazards TCs. The study reviewed incidents that listed their primary problem as weather or environment-nonweather between 1994 and 2011 for aircraft defined by Federal Aviation Regulations (FAR) Parts 121, 135, and 91. The study investigated the phases of flight, a variety of anomalies, flight conditions, and incidents by FAR part, along with other categories. The first part of the analysis focused on airframe-icing-related incidents and found 275 incidents out of 3526 weather-related incidents over the 18-yr period. The second portion of the study focused on atmospheric hazards and found 4647 incidents over the same time period. Atmospheric hazards-related incidents included a range of conditions from clear air turbulence and wake vortex, to controlled flight toward terrain, ground encounters, and incursions.

Final safety analysis report for the Ground Test Accelerator (GTA), Phase 2

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

NONE

1994-10-01

This document is the second volume of a 3 volume safety analysis report on the Ground Test Accelerator (GTA). The GTA program at the Los Alamos National Laboratory (LANL) is the major element of the national Neutral Particle Beam (NPB) program, which is supported by the Strategic Defense Initiative Office (SDIO). A principal goal of the national NPB program is to assess the feasibility of using hydrogen and deuterium neutral particle beams outside the Earth`s atmosphere. The main effort of the NPB program at Los Alamos concentrates on developing the GTA. The GTA is classified as a low-hazard facility, exceptmore » for the cryogenic-cooling system, which is classified as a moderate-hazard facility. This volume consists of failure modes and effects analysis; accident analysis; operational safety requirements; quality assurance program; ES&H management program; environmental, safety, and health systems critical to safety; summary of waste-management program; environmental monitoring program; facility expansion, decontamination, and decommissioning; summary of emergency response plan; summary plan for employee training; summary plan for operating procedures; glossary; and appendices A and B.« less

Towards a global system of vigilance and surveillance in unrelated donors of haematopoietic progenitor cells for transplantation.

PubMed

Shaw, B E; Chapman, J; Fechter, M; Foeken, L; Greinix, H; Hwang, W; Phillips-Johnson, L; Korhonen, M; Lindberg, B; Navarro, W H; Szer, J

2013-11-01

Safety of living donors is critical to the success of blood, tissue and organ transplantation. Structured and robust vigilance and surveillance systems exist as part of some national entities, but historically no global systems are in place to ensure conformity, harmonisation and the recognition of rare adverse events (AEs). The World Health Assembly has recently resolved to require AE/reaction (AE/R) reporting both nationally and globally. The World Marrow Donor Association (WMDA) is an international organisation promoting the safety of unrelated donors and progenitor cell products for use in haematopoietic progenitor cell (HPC) transplantation. To address this issue, we established a system for collecting, collating, analysing, distributing and reacting to serious adverse events and reactions (SAE/R) in unrelated HPC donors. The WMDA successfully instituted this reporting system with 203 SAE/R reported in 2011. The committee generated two rapid reports, reacting to specific SAE/R, resulting in practice changing policies. The system has a robust governance structure, formal feedback to the WMDA membership and transparent information flows to other agencies, specialist physicians and transplant programs and the general public.

Operational environments for electrical power wiring on NASA space systems

NASA Technical Reports Server (NTRS)

Stavnes, Mark W.; Hammoud, Ahmad N.; Bercaw, Robert W.

1994-01-01

Electrical wiring systems are used extensively on NASA space systems for power management and distribution, control and command, and data transmission. The reliability of these systems when exposed to the harsh environments of space is very critical to mission success and crew safety. Failures have been reported both on the ground and in flight due to arc tracking in the wiring harnesses, made possible by insulation degradation. This report was written as part of a NASA Office of Safety and Mission Assurance (Code Q) program to identify and characterize wiring systems in terms of their potential use in aerospace vehicles. The goal of the program is to provide the information and guidance needed to develop and qualify reliable, safe, lightweight wiring systems, which are resistant to arc tracking and suitable for use in space power applications. This report identifies the environments in which NASA spacecraft will operate, and determines the specific NASA testing requirements. A summary of related test programs is also given in this report. This data will be valuable to spacecraft designers in determining the best wiring constructions for the various NASA applications.

Integrating Data From the UK National Reporting and Learning System With Work Domain Analysis to Understand Patient Safety Incidents in Community Pharmacy.

PubMed

Phipps, Denham L; Tam, W Vanessa; Ashcroft, Darren M

2017-03-01

To explore the combined use of a critical incident database and work domain analysis to understand patient safety issues in a health-care setting. A retrospective review was conducted of incidents reported to the UK National Reporting and Learning System (NRLS) that involved community pharmacy between April 2005 and August 2010. A work domain analysis of community pharmacy was constructed using observational data from 5 community pharmacies, technical documentation, and a focus group with 6 pharmacists. Reports from the NRLS were mapped onto the model generated by the work domain analysis. Approximately 14,709 incident reports meeting the selection criteria were retrieved from the NRLS. Descriptive statistical analysis of these reports found that almost all of the incidents involved medication and that the most frequently occurring error types were dose/strength errors, incorrect medication, and incorrect formulation. The work domain analysis identified 4 overall purposes for community pharmacy: business viability, health promotion and clinical services, provision of medication, and use of medication. These purposes were served by lower-order characteristics of the work system (such as the functions, processes and objects). The tasks most frequently implicated in the incident reports were those involving medication storage, assembly, or patient medication records. Combining the insights from different analytical methods improves understanding of patient safety problems. Incident reporting data can be used to identify general patterns, whereas the work domain analysis can generate information about the contextual factors that surround a critical task.

Engineering a safe landing: engaging medical practitioners in a systems approach to patient safety.

PubMed

Brand, C; Ibrahim, J; Bain, C; Jones, C; King, B

2007-05-01

Several event studies, including the Australian Safety and Quality in Healthcare Study, emphasize gaps in safety for hospitalized patients. It is now recognized that system-based factors contribute significantly to risk of adverse events and this has led to a shift in focus of patient safety from the autonomous responsibility of medical clinicians to a systems-based approach. The aim of this study was to determine medical practitioner awareness of, level of engagement in and barriers to engagement in a systems approach to patient safety and quality. Information from acute and subacute care medical practitioners at a metropolitan public hospital was collected within an anonymous structured electronic survey, a discussion group and key informant interviews. There were 73 survey respondents (response rate 7.6%). Fifty-one (69.9%) were unaware of the Institute of Medicine report 'To Err is human'. Thirty-six (49.3%) were unaware of the Australian Quality in Healthcare Study and 12 (16.4%) had read the article. There was a positive relation identified between awareness and seniority. There was a low level of participation in systems-focused quality and safety activities and limited understanding of the role of systems in medical error causation. There was uncertainty about the changing role of medical practitioners in patient safety and perceived lack of skills to effectively engage with hospital management about safety and quality issues. Several factors are limiting engagement of medical practitioners in a systems approach to patient safety. Increased educational support is needed and may be best focused within clinical effectiveness activities pertinent to practitioner interest and expertise.

Proactive Regional Pharmacovigilance System Versus National Spontaneous Reporting for Collecting Safety Data on Concerning Off-Label Prescribing Practices: An Example with Baclofen and Alcohol Dependence in France.

PubMed

Auffret, Marine; Labreuche, Julien; Duhamel, Alain; Deheul, Sylvie; Cottencin, Olivier; Bordet, Régis; Gautier, Sophie; Rolland, Benjamin

2017-03-01

Off-label prescribing (OLP) may raise serious safety concerns that traditional spontaneous reporting of adverse drug reactions (ADRs) may not identify in a timely manner. In France, the 'Multidisciplinary Consultation Service for Off-Label Prescribing in Addiction Medicine' (CAMTEA) is a proactive regional system established to identify ADRs associated with the OLP of baclofen for alcohol dependence. The aim was to demonstrate, using the French pharmacovigilance database (FPVD), that CAMTEA allowed for the reporting of a substantial amount of ADRs, comparable in nature to those provided via spontaneous reporting. The 2012-2013 FPVD notifications associated with baclofen OLP were extracted. The ten most frequent types of ADRs among 'serious' and 'non-serious' reports were listed. The frequency of each type of ADR was compared between CAMTEA and spontaneous reporting, and the magnitudes of the differences were assessed using standardized differences. A total of 428 baclofen reports (1043 ADRs) were identified, among which 221 (51.64%) originated from CAMTEA. The ten most frequent ADRs in 'serious' reports were (1) confusion (17.3%), (2) seizures (11.5%), (3) drowsiness/sedation (11.5%), (4) agitation (10.9%), (5) coma (9.6%), (6) hallucinations (7.7%), (7) falls (7.1%), (8) behavioral disorders (5.8%), (9) withdrawal syndrome (5.1%), and (10) space-time disorientation (5.1%). A standardized difference of <0.2 was identified for six out of the ten most frequent 'serious' ADRs, and eight of the ten 'non-serious' ADRs. A proactive regional pharmacovigilance system could collect a substantial amount of safety data on a specific OLP practice. The profile of the ADRs collected was similar to that seen in the nationwide spontaneous reporting system.

Testing of state roadside safety systems. Volume I, Technical report

DOT National Transportation Integrated Search

1999-04-01

The purpose of this study is to crash test and evaluate new or modified roadside safety hardware and, where necessary, redesign the devices to improve their impact performance. The three major areas addressed in this study are the impact performance ...

Further Analysis of Motorcycle Helmet Effectiveness Using CODES Linked Data

DOT National Transportation Integrated Search

1998-01-01

Linked data from the Crash Outcome Data Evaluation System (CODES) in seven : states was used by the National Highway Traffic Safety Administration as the : basis of a 1996 Report to Congress on the Benefits of Safety Belts and : Motorcycle Helmets (D...

Recommendations for Highway Construction, Maintenance, and Service Equipment Warning Lights and Pavement Data Collection System Safety

DOT National Transportation Integrated Search

1998-10-01

This report presents the recommendations to improve the vehicle and equipment warning light policy for the Texas Department of Transportation, and improve the safety of the Department's pavement data collection activities. Research efforts include a ...

Safety of High Speed Guided Ground Transportation Systems: Collision Avoidance and Accident Survivability Volume 4: Proposed Specifications

DOT National Transportation Integrated Search

1993-03-01

This report is the fourth of four volumes concerned with developing safety guidelines and specifications for high-speed : guided ground transportation (HSGGT) collision avoidance and accident survivability. The overall approach taken in this : study ...

Safety of High Speed and Guided Ground Transportation Systems: Collision Avoidance and Accident Survivability: Volume 3

DOT National Transportation Integrated Search

1993-03-01

This report is the third of four volumes concerned with developing safety guidelines and specifications for high-speed : guided ground transportation (HSGGT) collision avoidance and accident survivability. The overall approach taken in : this study i...

Comprehensive target populations for current active safety systems using national crash databases.

PubMed

Kusano, Kristofer D; Gabler, Hampton C

2014-01-01

The objective of active safety systems is to prevent or mitigate collisions. A critical component in the design of active safety systems is the identification of the target population for a proposed system. The target population for an active safety system is that set of crashes that a proposed system could prevent or mitigate. Target crashes have scenarios in which the sensors and algorithms would likely activate. For example, the rear-end crash scenario, where the front of one vehicle contacts another vehicle traveling in the same direction and in the same lane as the striking vehicle, is one scenario for which forward collision warning (FCW) would be most effective in mitigating or preventing. This article presents a novel set of precrash scenarios based on coded variables from NHTSA's nationally representative crash databases in the United States. Using 4 databases (National Automotive Sampling System-General Estimates System [NASS-GES], NASS Crashworthiness Data System [NASS-CDS], Fatality Analysis Reporting System [FARS], and National Motor Vehicle Crash Causation Survey [NMVCCS]) the scenarios developed in this study can be used to quantify the number of police-reported crashes, seriously injured occupants, and fatalities that are applicable to proposed active safety systems. In this article, we use the precrash scenarios to identify the target populations for FCW, pedestrian crash avoidance systems (PCAS), lane departure warning (LDW), and vehicle-to-vehicle (V2V) or vehicle-to-infrastructure (V2I) systems. Crash scenarios were derived using precrash variables (critical event, accident type, precrash movement) present in all 4 data sources. This study found that these active safety systems could potentially mitigate approximately 1 in 5 of all severity and serious injury crashes in the United States and 26 percent of fatal crashes. Annually, this corresponds to 1.2 million all severity, 14,353 serious injury (MAIS 3+), and 7412 fatal crashes. In addition, we provide the source code for the crash scenarios as an appendix (see online supplement) to this article so that researchers can use the crash scenarios in future research.

Idaho National Laboratory Integrated Safety Management System FY 2016 Effectiveness Review and Declaration Report

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

Hunt, Farren J.

Idaho National Laboratory’s (INL’s) Integrated Safety Management System (ISMS) effectiveness review of fiscal year (FY) 2016 shows that INL has integrated management programs and safety elements throughout the oversight and operational activities performed at INL. The significant maturity of Contractor Assurance System (CAS) processes, as demonstrated across INL’s management systems and periodic reporting through the Management Review Meeting process, over the past two years has provided INL with current real-time understanding and knowledge pertaining to the health of the institution. INL’s sustained excellence of the Integrated Safety and effective implementation of the Worker Safety and Health Program is also evidencedmore » by other external validations and key indicators. In particular, external validations include VPP, ISO 14001, DOELAP accreditation, and key Laboratory level indicators such as ORPS (number, event frequency and severity); injury/illness indicators such as Days Away, Restricted and Transfer (DART) case rate, back & shoulder metric and open reporting indicators, demonstrate a continuous positive trend and therefore improved operational performance over the last few years. These indicators are also reflective of the Laboratory’s overall organizational and safety culture improvement. Notably, there has also been a step change in ESH&Q Leadership actions that have been recognized both locally and complex-wide. Notwithstanding, Laboratory management continues to monitor and take action on lower level negative trends in numerous areas including: Conduct of Operations, Work Control, Work Site Analysis, Risk Assessment, LO/TO, Fire Protection, and Life Safety Systems, to mention a few. While the number of severe injury cases has decreased, as evidenced by the reduction in the DART case rate, the two hand injuries and the fire truck/ambulance accident were of particular concern. Aggressive actions continue in order to understand the causes and define actions needed to prevent similar injuries and accidents in the future. While our injury rate is not where we want it to be, it is not the only indicator that defines our ISMS program, safety culture, and efforts to be a continuous learning organization. When reviewing the entire year’s performance, and all areas that integrate ISMS principles and core functions, INL has an “effective” ISMS program that is continually improving.« less

ITS Architecture Development Program, Phase I; Summary Report

DOT National Transportation Integrated Search

1994-11-01

IN-VEHICLE EMISSIONS DIAGNOSIS, COMMERCIAL VEHICLES OPERATIONS OR CVO, ADVANCED VEHICLE CONTROL AND SAFETY SYSTEMS OR AVCSS, ADVANCED PUBLIC TRANSPORTATION SYSTEMS OR APTS, INCIDENT MANAGEMENT/INCIDENT DETECTION, COLLISION AVOIDANCE SYSTEM, AUTOMATED...

A closer look at associations between hospital leadership walkrounds and patient safety climate and risk reduction: a cross-sectional study.

PubMed

Schwendimann, René; Milne, Judy; Frush, Karen; Ausserhofer, Dietmar; Frankel, Allan; Sexton, J Bryan

2013-01-01

Leadership walkrounds (WRs) are widely used in health care organizations to improve patient safety. This retrospective, cross-sectional study evaluated the association between WRs and caregiver assessments of patient safety climate and patient safety risk reduction across 49 hospitals in a nonprofit health care system. Linear regression analyses using units' participation in WRs were conducted. Survey results from 706 hospital units revealed that units with ≥ 60% of caregivers reporting exposure to at least 1 WR had a significantly higher safety climate, greater patient safety risk reduction, and a higher proportion of feedback on actions taken as a result of WRs compared with those units with <60% of caregivers reporting exposure to WRs. WR participation at the unit level reflects a frequency effect as a function of units with none/low, medium, and high leadership WR exposure.

[Systemic safety following intravitreal injections of anti-VEGF].

PubMed

Baillif, S; Levy, B; Girmens, J-F; Dumas, S; Tadayoni, R

2018-03-01

The goal of this manuscript is to assess data suggesting that intravitreal injection of anti-vascular endothelial growth factors (anti-VEGFs) could result in systemic adverse events (AEs). The class-specific systemic AEs should be similar to those encountered in cancer trials. The most frequent AE observed in oncology, hypertension and proteinuria, should thus be the most common expected in ophthalmology, but their severity should be lower because of the much lower doses of anti-VEGFs administered intravitreally. Such AEs have not been frequently reported in ophthalmology trials. In addition, pharmacokinetic and pharmacodynamic data describing systemic diffusion of anti-VEGFs should be interpreted with caution because of significant inconsistencies reported. Thus, safety data reported in ophthalmology trials and pharmacokinetic/pharmacodynamic data provide robust evidence that systemic events after intravitreal injection are very unlikely. Additional studies are needed to explore this issue further, as much remains to be understood about local and systemic side effects of anti-VEGFs. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

FY 1991 safety program status report

NASA Technical Reports Server (NTRS)

1991-01-01

In FY 1991, the NASA Safety Division continued efforts to enhance the quality and productivity of its safety oversight function. Recent initiatives set forth in areas such as training, risk management, safety assurance, operational safety, and safety information systems have matured into viable programs contributing to the safety and success of activities throughout the Agency. Efforts continued to develop a centralized intra-agency safety training program with establishment of the NASA Safety Training Center at the Johnson Space Center (JSC). The objective is to provide quality training for NASA employees and contractors on a broad range of safety-related topics. Courses developed by the Training Center will be presented at various NASA locations to minimize travel and reach the greatest number of people at the least cost. In FY 1991, as part of the ongoing efforts to enhance the total quality of NASA's safety work force, the Safety Training Center initiated development of a Certified Safety Professional review course. This course provides a comprehensive review of the skills and knowledge that well-rounded safety professionals must possess to qualify for professional certification. FY 1992 will see the course presented to NASA and contractor employees at all installations via the NASA Video Teleconference System.

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

PubMed

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

2015-12-01

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

Defense Occupational and Environmental Health Readiness System (DOEHRS) Guidance

DTIC Science & Technology

2009-07-01

TERMS Defense Occupational and Environmental Health Reporting System (DOEHRS), Industrial Hygiene, Environmental Health, Information Management System Hygiene...Information System (AF EMIS), the Air Force Enterprise Environmental, Safety, and Occupational Health Information Management System (EESOH MIS), or the

[Study of post marketing safety reevaluation of shenqi fuzheng injection].

PubMed

Ai, Qing-Hua; Li, Yuan-Yuan; Xie, Yan-Ming

2014-09-01

In order to promote the Shenqifuzheng injection (SQFZ) clinical medication safety, this study reevaluate on SQFZ post marketing safety study systematically. Including multi center large sample registration type safety monitoring research, the analysis based on national spontaneous reporting system data, the analysis based on the 20 national hospital information system data and literature research. Above the analysis, it suggests that SQFZ has good security. The more adverse drug reaction (ADR) as allergic reactions, mainly involved in the damage of skin, appendages and its systemic damage, serious person can appear allergic shock. ADR/E is more common in the elderly, may be related to medication (tumor) populations. Early warning analysis based on SRS data and literature research are of the view that "phlebitis" has a strong association with SQFZ used.

NASA Aviation Safety Reporting System

NASA Technical Reports Server (NTRS)

1980-01-01

Problems in briefing of relief by air traffic controllers are discussed, including problems that arise when duty positions are changed by controllers. Altimeter reading and setting errors as factors in aviation safety are discussed, including problems associated with altitude-including instruments. A sample of reports from pilots and controllers is included, covering the topics of ATIS broadcasts an clearance readback problems. A selection of Alert Bulletins, with their responses, is included.

Interpreting MSHA citations through the lens of occupational health and safety management systems: investigating their impact on mine injuries and illnesses 2003-2010.

PubMed

Yorio, Patrick L; Willmer, Dana R; Haight, Joel M

2014-08-01

Since the late 1980s, the U.S. Department of Labor has considered regulating a systems approach to occupational health and safety management. Recently, a health and safety management systems (HSMS) standard has returned to the regulatory agenda of both the Occupational Safety and Health Administration (OSHA) and the Mine Safety and Health Administration (MSHA). Because a mandated standard has implications for both industry and regulating bodies alike, it is imperative to gain a greater understanding of the potential effects that an HSMS regulatory approach can have on establishment-level injuries and illnesses. Through the lens of MSHA's regulatory framework, we first explore how current enforcement activities align with HSMS elements. Using MSHA data for the years 2003-2010, we then analyze the relationship between various types of enforcement activities (e.g., total number of citations, total penalty amount, and HSMS-aligned citations) and mine reportable injuries. Our findings show that the reduction in mine reportable injuries predicted by increases in MSHA enforcement ranges from negligible to 18%. The results suggest that the type and focus of the enforcement activity may be more important for accident reduction than the total number of citations issued and the associated penalty amount. © 2014 Society for Risk Analysis.

Safety-related requirements for photovoltaic modules and arrays. Final report

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

Levins, A.

1984-03-01

Underwriters Laboratories has conducted a study to identify and develop safety requirements for photovoltaic module and panel designs and configurations for residential, intermediate, and large scale applications. Concepts for safety systems, where each system is a collection of subsystems which together address the total anticipated hazard situation, are described. Descriptions of hardware, and system usefulness and viability are included. This discussion of safety systems recognizes that there is little history on which to base the expected safety related performance of a photovoltaic system. A comparison of these systems, as against the provisions of the 1984 National Electrical Code covering photovoltaicmore » systems is made. A discussion of the UL investigation of the photovoltaic module evaluated to the provisions of the Proposed UL Standard for Flat-Plate Photovoltaic Modules and Panels is included. Grounding systems, their basis and nature, and the advantages and disadvantages of each are described. The meaning of frame grounding, circuit grounding, and the type of circuit ground are covered. The development of the Standard for Flat-Plate Photovoltaic Modules and Panels has continued, and with both industry comment and a product submittal and listing, the Standard has been refined to a viable document allowing an objective safety review of photovoltaic modules and panels. How this document, and other UL documents would cover investigations of certain other photovoltaic system components is described.« less

Systems Analysis of NASA Aviation Safety Program: Final Report

NASA Technical Reports Server (NTRS)

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

2013-01-01

A three-month study (February to April 2010) of the NASA Aviation Safety (AvSafe) program was conducted. This study comprised three components: (1) a statistical analysis of currently available civilian subsonic aircraft data from the National Transportation Safety Board (NTSB), the Federal Aviation Administration (FAA), and the Aviation Safety Information Analysis and Sharing (ASIAS) system to identify any significant or overlooked aviation safety issues; (2) a high-level qualitative identification of future safety risks, with an assessment of the potential impact of the NASA AvSafe research on the National Airspace System (NAS) based on these risks; and (3) a detailed, top-down analysis of the NASA AvSafe program using an established and peer-reviewed systems analysis methodology. The statistical analysis identified the top aviation "tall poles" based on NTSB accident and FAA incident data from 1997 to 2006. A separate examination of medical helicopter accidents in the United States was also conducted. Multiple external sources were used to develop a compilation of ten "tall poles" in future safety issues/risks. The top-down analysis of the AvSafe was conducted by using a modification of the Gibson methodology. Of the 17 challenging safety issues that were identified, 11 were directly addressed by the AvSafe program research portfolio.

Short communication: Labeling Listeria with anaerobic fluorescent protein for food safety studies.

PubMed

Landete, José M; Peirotén, Ángela; Medina, Margarita; Arqués, Juan L

2017-01-01

Many food safety-related studies require the tracking of inoculated food-borne pathogens to monitor their fate in food complex environments. In the current study, we demonstrate the potential of plasmids containing the fluorescence protein gene evoglow-Pp1 (Evocatal, Dusseldorf, Germany) as a real-time reporter system for Listeria strains. This anaerobic fluorescent protein provides an easily detectable phenotype of microorganisms for food safety studies. This work is the first to report a reliable method to identify fluorescently labeled Listeria strains in food ecosystems. Copyright © 2017 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Do not blame the driver: a systems analysis of the causes of road freight crashes.

PubMed

Newnam, Sharon; Goode, Natassia

2015-03-01

Although many have advocated a systems approach in road transportation, this view has not meaningfully penetrated road safety research, practice or policy. In this study, a systems theory-based approach, Rasmussens's (1997) risk management framework and associated Accimap technique, is applied to the analysis of road freight transportation crashes. Twenty-seven highway crash investigation reports were downloaded from the National Transport Safety Bureau website. Thematic analysis was used to identify the complex system of contributory factors, and relationships, identified within the reports. The Accimap technique was then used to represent the linkages and dependencies within and across system levels in the road freight transportation industry and to identify common factors and interactions across multiple crashes. The results demonstrate how a systems approach can increase knowledge in this safety critical domain, while the findings can be used to guide prevention efforts and the development of system-based investigation processes for the heavy vehicle industry. A research agenda for developing an investigation technique to better support the application of the Accimap technique by practitioners in road freight transportation industry is proposed. Copyright © 2015 Elsevier Ltd. All rights reserved.

Global Positioning System: Observations on Quarterly Reports from the Air Force

DTIC Science & Technology

2016-10-17

Positioning System : Observations on Quarterly Reports from the Air Force The satellite-based Global Positioning System (GPS) provides positioning, navigation...infrastructure, and transportation safety. The Department of Defense (DOD)—specifically, the Air Force—develops and operates the GPS system , which...programs, including the most recent detailed assessment of the next generation operational control system (OCX) and development of military GPS

NASA Accident Precursor Analysis Handbook, Version 1.0

NASA Technical Reports Server (NTRS)

Groen, Frank; Everett, Chris; Hall, Anthony; Insley, Scott

2011-01-01

Catastrophic accidents are usually preceded by precursory events that, although observable, are not recognized as harbingers of a tragedy until after the fact. In the nuclear industry, the Three Mile Island accident was preceded by at least two events portending the potential for severe consequences from an underappreciated causal mechanism. Anomalies whose failure mechanisms were integral to the losses of Space Transportation Systems (STS) Challenger and Columbia had been occurring within the STS fleet prior to those accidents. Both the Rogers Commission Report and the Columbia Accident Investigation Board report found that processes in place at the time did not respond to the prior anomalies in a way that shed light on their true risk implications. This includes the concern that, in the words of the NASA Aerospace Safety Advisory Panel (ASAP), "no process addresses the need to update a hazard analysis when anomalies occur" At a broader level, the ASAP noted in 2007 that NASA "could better gauge the likelihood of losses by developing leading indicators, rather than continue to depend on lagging indicators". These observations suggest a need to revalidate prior assumptions and conclusions of existing safety (and reliability) analyses, as well as to consider the potential for previously unrecognized accident scenarios, when unexpected or otherwise undesired behaviors of the system are observed. This need is also discussed in NASA's system safety handbook, which advocates a view of safety assurance as driving a program to take steps that are necessary to establish and maintain a valid and credible argument for the safety of its missions. It is the premise of this handbook that making cases for safety more experience-based allows NASA to be better informed about the safety performance of its systems, and will ultimately help it to manage safety in a more effective manner. The APA process described in this handbook provides a systematic means of analyzing candidate accident precursors by evaluating anomaly occurrences for their system safety implications and, through both analytical and deliberative methods used to project to other circumstances, identifying those that portend more serious consequences to come if effective corrective action is not taken. APA builds upon existing safety analysis processes currently in practice within NASA, leveraging their results to provide an improved understanding of overall system risk. As such, APA represents an important dimension of safety evaluation; as operational experience is acquired, precursor information is generated such that it can be fed back into system safety analyses to risk-inform safety improvements. Importantly, APA utilizes anomaly data to predict risk whereas standard reliability and PRA approaches utilize failure data which often is limited and rare.

Bisphosphonates and Nonhealing Femoral Fractures: Analysis of the FDA Adverse Event Reporting System (FAERS) and International Safety Efforts

PubMed Central

Edwards, Beatrice J.; Bunta, Andrew D.; Lane, Joseph; Odvina, Clarita; Rao, D. Sudhaker; Raisch, Dennis W.; McKoy, June M.; Omar, Imran; Belknap, Steven M.; Garg, Vishvas; Hahr, Allison J.; Samaras, Athena T.; Fisher, Matthew J.; West, Dennis P.; Langman, Craig B.; Stern, Paula H.

2013-01-01

Background: In the United States, hip fracture rates have declined by 30% coincident with bisphosphonate use. However, bisphosphonates are associated with sporadic cases of atypical femoral fracture. Atypical femoral fractures are usually atraumatic, may be bilateral, are occasionally preceded by prodromal thigh pain, and may have delayed fracture-healing. This study assessed the occurrence of bisphosphonate-associated nonhealing femoral fractures through a review of data from the U.S. FDA (Food and Drug Administration) Adverse Event Reporting System (FAERS) (1996 to 2011), published case reports, and international safety efforts. Methods: We analyzed the FAERS database with use of the proportional reporting ratio (PRR) and empiric Bayesian geometric mean (EBGM) techniques to assess whether a safety signal existed. Additionally, we conducted a systematic literature review (1990 to February 2012). Results: The analysis of the FAERS database indicated a PRR of 4.51 (95% confidence interval [CI], 3.44 to 5.92) for bisphosphonate use and nonhealing femoral fractures. Most cases (n = 317) were attributed to use of alendronate (PRR = 3.32; 95% CI, 2.71 to 4.17). In 2008, international safety agencies issued warnings and required label changes. In 2010, the FDA issued a safety notification, and the American Society for Bone and Mineral Research (ASBMR) issued recommendations about bisphosphonate-associated atypical femoral fractures. Conclusions: Nonhealing femoral fractures are unusual adverse drug reactions associated with bisphosphonate use, as up to 26% of published cases of atypical femoral fractures exhibited delayed healing or nonhealing. PMID:23426763

Improving Safety through Human Factors Engineering.

PubMed

Siewert, Bettina; Hochman, Mary G

2015-10-01

Human factors engineering (HFE) focuses on the design and analysis of interactive systems that involve people, technical equipment, and work environment. HFE is informed by knowledge of human characteristics. It complements existing patient safety efforts by specifically taking into consideration that, as humans, frontline staff will inevitably make mistakes. Therefore, the systems with which they interact should be designed for the anticipation and mitigation of human errors. The goal of HFE is to optimize the interaction of humans with their work environment and technical equipment to maximize safety and efficiency. Special safeguards include usability testing, standardization of processes, and use of checklists and forcing functions. However, the effectiveness of the safety program and resiliency of the organization depend on timely reporting of all safety events independent of patient harm, including perceived potential risks, bad outcomes that occur even when proper protocols have been followed, and episodes of "improvisation" when formal guidelines are found not to exist. Therefore, an institution must adopt a robust culture of safety, where the focus is shifted from blaming individuals for errors to preventing future errors, and where barriers to speaking up-including barriers introduced by steep authority gradients-are minimized. This requires creation of formal guidelines to address safety concerns, establishment of unified teams with open communication and shared responsibility for patient safety, and education of managers and senior physicians to perceive the reporting of safety concerns as a benefit rather than a threat. © RSNA, 2015.

Safety of high-speed guided ground transportation systems : collision avoidance and accident survivability : volume 4 : proposed specifications

DOT National Transportation Integrated Search

1993-03-01

This report is the fourth of four volumes concerned with developing safety guidelines and specifications for high-speed guided ground transportation (HSGGT) collision avoidance and accident survivability. The overall approach taken in this study is t...

Safety of high-speed guided ground transportation systems : collision avoidance and accident survivability : volume 3 : accident survivability

DOT National Transportation Integrated Search

1993-03-01

This report is the third of four volumes concerned with developing safety guidelines and specifications for high-speed guided ground transportation (HSGGT) collision avoidance and accident survivability. The overall approach taken in this study is to...

Safety of High Speed and Ground Guided Transportation Systems: Collision Avoidance and Accident Survivability: Volume 1: Collision Threat

DOT National Transportation Integrated Search

1993-03-01

This report is the first of four volunes concerned with developing safety guidelines and specifications for high-speed : guided ground transportation (HSGGT) collision avoidance and accident survivability. The overall approach taken in this : study i...

NASA System Safety Framework and Concepts for Implementation

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon

2012-01-01

This report has been developed by the National Aeronautics and Space Administration (NASA) Human Exploration and Operations Mission Directorate (HEOMD) Risk Management team knowledge capture forums.. This document provides a point-in-time, cumulative, summary of actionable key lessons learned in safety framework and concepts.

Safety of High Speed Magnetic Levitation Transportation Systems : Thermal Effects and Related Safety Issues of Typical Maglev Steel Guideways

DOT National Transportation Integrated Search

1994-09-01

This report presents a theoretical analysis predicting the temperature distribution, thermal deflections, and thermal stresses that may occur in typical steel Maglev guideways under the proposed Orlando FL thermal environment. Transient, finite eleme...

Highway safety performance metrics and emergency response in an advanced transportation environment : final report.

DOT National Transportation Integrated Search

2016-06-01

Traditional highway safety performance metrics have been largely based on fatal crashes and more recently serious injury crashes. In the near future however, there may be less severe motor vehicle crashes due to advances in driver assistance systems,...

Safety of high-speed guided ground transportation systems : collision avoidance and accident survivability : volume 2 : collision avoidance

DOT National Transportation Integrated Search

1993-03-01

This report is the second of four volumes concerned with developing safety guidelines and specifications for high-speed guided ground transportation (HSGGT) collision avoidance and accident survivability. The overall approach taken in this study is t...

Making safety an integral part of 5S in healthcare.

PubMed

Ikuma, Laura H; Nahmens, Isabelina

2014-01-01

Healthcare faces major challenges with provider safety and rising costs, and many organizations are using Lean to instigate change. One Lean tool, 5S, is becoming popular for improving efficiency of physical work environments, and it can also improve safety. This paper demonstrates that safety is an integral part of 5S by examining five specific 5S events in acute care facilities. We provide two arguments for how safety is linked to 5S:1. Safety is affected by 5S events, regardless of whether safety is a specific goal and 2. Safety can and should permeate all five S's as part of a comprehensive plan for system improvement. Reports of 5S events from five departments in one health system were used to evaluate how changes made at each step of the 5S impacted safety. Safety was affected positively in each step of the 5S through initial safety goals and side effects of other changes. The case studies show that 5S can be a mechanism for improving safety. Practitioners may reap additional safety benefits by incorporating safety into 5S events through a safety analysis before the 5S, safety goals and considerations during the 5S, and follow-up safety analysis.

Y-12 PLANT NUCLEAR SAFETY HANDBOOK

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

Wachter, J.W. ed.; Bailey, M.L.; Cagle, T.J.

1963-03-27

Information needed to solve nuclear safety problems is condensed into a reference book for use by persons familiar with the field. Included are a glossary of terms; useful tables; nuclear constants; criticality calculations; basic nuclear safety limits; solution geometries and critical values; metal critical values; criticality values for intermediate, heterogeneous, and interacting systems; miscellaneous and related information; and report number, author, and subject indexes. (C.H.)

Mechanisms of slow-pitch softball injuries reported to the HQ Air Force Safety Center a 10-year descriptive study, 1993-2002.

PubMed

Burnham, Bruce R; Copley, G Bruce; Shim, Matthew J; Kemp, Philip A; Jones, Bruce H

2010-01-01

Softball is a popular sport in civilian and military populations and results in a large number of lost-workday injuries. The purpose of this study is to describe the mechanisms associated with softball injuries occurring among active duty U.S. Air Force (USAF) personnel to better identify potentially effective countermeasures. Data derived from safety reports were obtained from the USAF Ground Safety Automated System in 2003. Softball injuries for the years 1993-2002 that resulted in at least one lost workday were included in the study. Narrative data were systematically reviewed and coded in order to categorize and summarize mechanisms associated with these injuries. This report documents a total of 1181 softball-related mishap reports, involving 1171 active duty USAF members who sustained one lost-workday injury while playing softball. Eight independent mechanisms were identified. Three specific scenarios (sliding, being hit by a ball, and colliding with a player) accounted for 60% of reported softball injuries. Mechanisms of injury for activities such as playing softball, necessary for prevention planning, can be identified using the detailed information found in safety reports. This information should also be used to develop better sports injury coding systems. Within the USAF and U.S. softball community, interventions to reduce injuries related to the most common mechanisms (sliding, being hit by a ball, and colliding with a player) should be developed, implemented, and evaluated. Published by Elsevier Inc.

Intravenous medication safety and smart infusion systems: lessons learned and future opportunities.

PubMed

Keohane, Carol A; Hayes, Judy; Saniuk, Catherine; Rothschild, Jeffrey M; Bates, David W

2005-01-01

The Institute of Medicine report To Err Is Human: Building a Safe Health System greatly increased national awareness of the need to improve patient safety in general and medication safety in particular. Infusion-related errors are associated with the greatest risk of harm, and "smart" (computerized) infusion systems are currently available that can avert high-risk errors and provide previously unavailable data for continuous quality improvement (CQI) efforts. As healthcare organizations consider how to invest scarce dollars, infusion nurses have a key role to play in assessing need, evaluating technology, and selecting and implementing specific products. This article reviews the need to improve intravenous medication safety. It describes smart infusion systems and the results they have achieved. Finally, it details the lessons learned and the opportunities identified through the use of smart infusion technology at Brigham and Women's Hospital in Boston, Massachusetts.

What Does a Hospital Survey on Patient Safety Reveal About Patient Safety Culture of Surgical Units Compared With That of Other Units?

PubMed Central

Shu, Qin; Cai, Miao; Tao, Hong-bing; Cheng, Zhao-hui; Chen, Jing; Hu, Yin-huan; Li, Gang

2015-01-01

Abstract The objective of this study was to examine the strengths and weaknesses of surgical units as compared with other units, and to provide an opportunity to improve patient safety culture in surgical settings by suggesting targeted actions using Hospital Survey on Patient Safety Culture (HSOPSC) investigation. A Hospital Survey on Patient Safety questionnaire was conducted to physicians and nurses in a tertiary hospital in Shandong China. 12 patient safety culture dimensions and 2 outcome variables were measured. A total of 23.5% of respondents came from surgical units, and 76.5% worked in other units. The “overall perceptions of safety” (48.1% vs 40.4%, P < 0.001) and “frequency of events reported” (63.7% vs 60.7%, P = 0.001) of surgical units were higher than those of other units. However, the communication openness (38.7% vs 42.5%, P < 0.001) of surgical units was lower than in other units. Medical workers in surgical units reported more events than those in other units, and more respondents in the surgical units assess “patient safety grade” to be good/excellent. Three dimensions were considered as strengths, whereas 5 other dimensions were considered to be weaknesses in surgical units. Six dimensions have potential to aid in improving events reporting and patient safety grade. Appropriate working times will also contribute to ensuring patient safety. Medical staff with longer years of experience reported more events. Surgical units outperform the nonsurgical ones in overall perception of safety and the number of events reported but underperform in the openness of communication. Four strategies, namely deepening the understanding about patient safety of supervisors, narrowing the communication gap within and across clinical units, recruiting more workers, and employing the event reporting system and building a nonpunitive culture, are recommended to improve patient safety in surgical units in the context of 1 hospital. PMID:26166083

Volvo drivers' experiences with advanced crash avoidance and related technologies.

PubMed

Eichelberger, Angela H; McCartt, Anne T

2014-01-01

Crash avoidance technologies can potentially prevent or mitigate many crashes, but their success depends in part on driver acceptance. Owners of 2010-2012 model Volvo vehicles with several technologies were interviewed about their experiences. Interviews were conducted in summer 2012 with 155 owners of vehicles with City Safety as a standard feature; 145 owners with an optional technology package that included adaptive cruise control, distance alert, collision warning with full auto brake (and pedestrian detection on certain models), driver alert control, and lane departure warning; and 172 owners with both City Safety and the technology package. The survey response rates were 21 percent for owners with City Safety, 30 percent for owners with the technology package, and 27 percent for owners with both. Ten percent of owners opted out before the telephone survey began, and 18 percent declined to participate when called. Despite some annoyance, most respondents always leave the systems on, although fewer do so for lane departure warning (59%). For each of the systems, at least 80 percent of respondents with the system would want it on their next vehicle. Many respondents reported safer driving habits with the systems (e.g., following less closely with adaptive cruise control, using turn signals more often with lane departure warning). Fewer respondents reported potentially unsafe behavior, such as allowing the vehicle to brake for them at least some of the time. About one third of respondents experienced autonomous braking when they believed they were at risk of crashing, and about one fifth of respondents thought it had prevented a crash. About one fifth of respondents with the technology package reported that they were confused or misunderstood which safety system had activated in their vehicle. Consistent with the results for early adopters in the previous survey of Volvo and Infiniti owners, the present survey found that driver acceptance of the technologies remains high, although less so for lane departure warning. This study is the first to report drivers' experiences with City Safety, a collision avoidance system provided as standard equipment on certain Volvo 2010-2012 models, and driver acceptance of this system was high, although not to the same extent as the optional forward collision avoidance system. Future research should continue to monitor drivers' experiences with these technologies as they become available in more vehicles.

Report: EPA’s and Louisiana’s Efforts to Assess and Restore Public Drinking Water Systems after Hurricane Katrina

EPA Pesticide Factsheets

Report #2006-P-00014, March 7, 2006. The Louisiana Department of Health and Hospitals and drinking water systems operators provided the public with timely and accurate information about the safety and proper treatment of drinking water.

Under-reporting of work-related disorders in the workplace: a case study and review of the literature.

PubMed

Pransky, G; Snyder, T; Dembe, A; Himmelstein, J

1999-01-01

Accurate reporting of work-related conditions is necessary to monitor workplace health and safety, and to identify the interventions that are most needed. Reporting systems may be designed primarily for external agencies (OSHA or workers' compensation) or for the employer's own use. Under-reporting of workplace injuries and illnesses is common due to a variety of causes and influences. Based on previous reports, the authors were especially interested in the role of safety incentive programmes on under-reporting. Safety incentive programmes typically reward supervisors and employees for reducing workplace injury rates, and thus may unintentionally inhibit proper reporting. The authors describe a case study of several industrial facilities in order to illustrate the extent of under-reporting and the reasons for its occurrence. A questionnaire and interview survey was administered to 110 workers performing similar tasks and several managers, health, and safety personnel at each of three industrial facilities. Although less than 5% of workers had officially reported a work-related injury or illness during the past year, over 85% experienced work-related symptoms, 50% had persistent work-related problems, and 30% reported either lost time from work or work restrictions because of their ailment. Workers described several reasons for not reporting their injuries, including fear of reprisal, a belief that pain was an ordinary consequence of work activity or ageing, lack of management responsiveness after prior reports, and a desire not to lose their usual job. Interviews with management representatives revealed administrative and other barriers to reporting, stemming from their desire to attain a goal of no reported injuries, and misconceptions about requirements for recordability. The corporate and facility safety incentives appeared to have an indirect, but significant negative influence on the proper reporting of workplace injuries by workers. A variety of influences may contribute to under-reporting; because of under-reporting, worker surveys and symptom reports may provide more valuable and timely information on risks than recordable injury logs. Safety incentive programmes should be carefully designed to ensure that they provide a stimulus for safety-related changes, and to discourage under-reporting. A case-control study of similar establishments, or data before and after instituting safety incentives, would be required to more clearly establish the role of these programmes in under-reporting.

Fire Safety Tests for Cesium-Loaded Spherical Resorcinol Formaldehyde Resin: Data Summary Report

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

Kim, Dong-Sang; Schweiger, Michael J.; Peterson, Reid A.

2012-09-01

A draft safety evaluation of the scenario for spherical resorcinol formaldehyde (SRF) resin fire inside the ion exchange column was performed by the Hanford Tank Waste Treatment and Immobilization Plant (WTP) Fire Safety organization. The result of this draft evaluation suggested a potential change of the fire safety classification for the Cesium Ion Exchange Process System (CXP) emergency elution vessels, equipment, and piping. To resolve this question, the fire properties of the SRF resin were measured by Southwest Research Institute (SwRI) through a subcontract managed by Pacific Northwest National Laboratory (PNNL). The results of initial fire safety tests on themore » SRF resin were documented in a previous report (WTP-RPT-218). The present report summarizes the results of additional tests performed by SwRI on the cesium-loaded SRF resin. The efforts by PNNL were limited to summarizing the test results provided by SwRI into one consolidated data report. The as-received SwRI report is attached to this report in the Appendix A. Where applicable, the precision and bias of each test method, as given by each American Society for Testing and Materials (ASTM) standard procedure, are included and compared with the SwRI test results of the cesium-loaded SRF resin.« less

[Patient safety and errors in medicine: development, prevention and analyses of incidents].

PubMed

Rall, M; Manser, T; Guggenberger, H; Gaba, D M; Unertl, K

2001-06-01

"Patient safety" and "errors in medicine" are issues gaining more and more prominence in the eyes of the public. According to newer studies, errors in medicine are among the ten major causes of death in association with the whole area of health care. A new era has begun incorporating attention to a "systems" approach to deal with errors and their causes in the health system. In other high-risk domains with a high demand for safety (such as the nuclear power industry and aviation) many strategies to enhance safety have been established. It is time to study these strategies, to adapt them if necessary and apply them to the field of medicine. These strategies include: to teach people how errors evolve in complex working domains and how types of errors are classified; the introduction of critical incident reporting systems that are free of negative consequences for the reporters; the promotion of continuous medical education; and the development of generic problem-solving skills incorporating the extensive use of realistic simulators wherever possible. Interestingly, the field of anesthesiology--within which realistic simulators were developed--is referred to as a model for the new patient safety movement. Despite this proud track record in recent times though, there is still much to be done even in the field of anesthesiology. Overall though, the most important strategy towards a long-term improvement in patient safety will be a change of "culture" throughout the entire health care system. The "culture of blame" focused on individuals should be replaced by a "safety culture", that sees errors and critical incidents as a problem of the whole organization. The acceptance of human fallability and an open-minded non-punitive analysis of errors in the sense of a "preventive and proactive safety culture" should lead to solutions at the systemic level. This change in culture can only be achieved with a strong commitment from the highest levels of an organization. Patient safety must have the highest priority in the goals of the institution: "Primum nihil nocere"--"First, do not harm".

Provincial drug plan officials' views of the Canadian drug safety system.

PubMed

Lexchin, Joel; Wiktorowicz, Mary; Moscou, Kathy; Eggertson, Laura

2013-06-01

The Canadian constitution divides the responsibility for pharmaceuticals between the federal and provincial governments. While the provincial governments are responsible for establishing public formularies, the majority of the safety and efficacy information that the provinces use comes from the federal government. We interviewed drug plan officials from eight of the ten provinces and two of three territories regarding their views on the Canadian drug safety system. Here we report on the following categories: the federal drug approval system; the strengths and weaknesses of the federal system of postmarket pharmaceutical safety (i.e., pharmacosurveillance); resources available to support provincial formulary decision making; provincial roles in pharmacosurveillance; how the drug safety system could be improved; and the role of the Drug Safety and Effectiveness Network, a recently established virtual network designed to connect researchers throughout Canada who conduct postmarket drug research. Next, we place the Canadian system within an international context by comparing informational asymmetry between government institutions in the United States and the European Union and by looking at how institutions support each other's roles in sharing information and in jointly developing policy through the International Conference on Harmonization. Finally, we draw on international experiences and suggest potential solutions to the concerns that our key informants have identified.

[Results of provisional use of a system for voluntary anonymous reporting of incidents that threaten patient safety in the emergency medical services of Asturias].

PubMed

Galván Núñez, Pablo; Santander Barrios, María Dolores; Villa Álvarez, María Cristina; Castro Delgado, Rafael; Alonso Lorenzo, Julio C; Arcos González, Pedro

2016-06-01

To describe the reported incidents and adverse events in the emergency medical services of Asturias, Spain, and assess their consequences, delays caused, and preventability. Prospective, observational study of incidents reported by the staff of the emergency medical services of Asturias after implementation of a system devised by the researchers. Incident reports were received for 0.48% (95% CI, 0.41%-0.54%) of the emergencies attended. Patient safety was compromised in 74.7% of the reported incidents. Problems arising in the emergency response coordination center (ERCC) accounted for 37.6% of the incidents, transport problems for 13.4%, vehicular problems for 10.8%, and communication problems for 8.8%. Seventy percent of the reported incidents caused delays in care; 55% of the reported incidents that put patients at risk (according to severity assessment code ratings) corresponded to problems related to human or material resources. A total of 88.1% of the incidents reported were considered avoidable. Some type of intervention was required to attenuate the effects of 46.2% of the adverse events reported. The measures that staff members most often proposed to prevent adverse events were to increase human and material resources (28.3%), establish protocols (14.5%), and comply with quality of care recommendations (9.7%). It is important to promote a culture of safety and incident reporting among health care staff in Asturias given the number of serious adverse events. Reporting is necessary for understanding the errors made and taking steps to prevent them. The ERCC is the point in the system where incidents are particularly likely to appear and be noticed and reported.

NASA's aviation safety research and technology program

NASA Technical Reports Server (NTRS)

Fichtl, G. H.

1977-01-01

Aviation safety is challenged by the practical necessity of compromising inherent factors of design, environment, and operation. If accidents are to be avoided these factors must be controlled to a degree not often required by other transport modes. The operational problems which challenge safety seem to occur most often in the interfaces within and between the design, the environment, and operations where mismatches occur due to ignorance or lack of sufficient understanding of these interactions. Under this report the following topics are summarized: (1) The nature of operating problems, (2) NASA aviation safety research, (3) clear air turbulence characterization and prediction, (4) CAT detection, (5) Measurement of Atmospheric Turbulence (MAT) Program, (6) Lightning, (7) Thunderstorm gust fronts, (8) Aircraft ground operating problems, (9) Aircraft fire technology, (10) Crashworthiness research, (11) Aircraft wake vortex hazard research, and (12) Aviation safety reporting system.

Improving the safety of vaccine delivery.

PubMed

Evans, Huw P; Cooper, Alison; Williams, Huw; Carson-Stevens, Andrew

2016-05-03

Vaccines save millions of lives per annum as an integral part of community primary care provision worldwide. Adverse events due to the vaccine delivery process outnumber those arising from the pharmacological properties of the vaccines themselves. Whilst one in three patients receiving a vaccine will encounter some form of error, little is known about their underlying causes and how to mitigate them in practice. Patient safety incident reporting systems and adverse drug event surveillance offer a rich opportunity for understanding the underlying causes of those errors. Reducing harm relies on the identification and implementation of changes to improve vaccine safety at multiple levels: from patient interventions through to organizational actions at local, national and international levels. Here we highlight the potential for maximizing learning from patient safety incident reports to improve the quality and safety of vaccine delivery.

The effect of organisational culture on patient safety.

PubMed

Kaufman, Gerri; McCaughan, Dorothy

This article explores the links between organisational culture and patient safety. The key elements associated with a safety culture, most notably effective leadership, good teamwork, a culture of learning and fairness, and fostering patient-centred care, are discussed. The broader aspects of a systems approach to promoting quality and safety, with specific reference to clinical governance, human factors, and ergonomics principles and methods, are also briefly explored, particularly in light of the report of the public inquiry into care failings at Mid Staffordshire NHS Foundation Trust.

Testing of Safety-Critical Software Embedded in an Artificial Heart

NASA Astrophysics Data System (ADS)

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

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

Accidents and Apathy: The Construction of the ‘Robens Philosophy’ of Occupational Safety and Health Regulation in Britain, 1961–1974

PubMed Central

Sirrs, Christopher

2016-01-01

The 1972 Robens Report is widely regarded to have provided the underlying rationale for the ‘modern’ system of occupational health and safety regulation in Britain, embodied in the Health and Safety at Work Act (HSW Act) 1974. The HSW Act advanced a new, more flexible system of regulation, premised on the ideal of self-regulation by industry. This article advances a more nuanced historical understanding of the Report and its ethos—the ‘Robens philosophy’—than hitherto developed, situating its assumptions about accidents, regulation and the role of the state in the social, economic and political context of Britain in the 1960s and early 1970s. Highlighting the interaction between these trends and long-established regulatory practices, the article argues that the turn to ‘self-regulation’ heralded by the Robens Report was highly convincing from a political and regulatory perspective at the time it was promulgated. PMID:26858514

49 CFR 234.109 - Recordkeeping.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION GRADE CROSSING SAFETY, INCLUDING SIGNAL SYSTEMS, STATE ACTION PLANS, AND EMERGENCY NOTIFICATION SYSTEMS Response to Credible Reports of Warning System Malfunction at Highway-Rail...

49 CFR 234.109 - Recordkeeping.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION GRADE CROSSING SAFETY, INCLUDING SIGNAL SYSTEMS, STATE ACTION PLANS, AND EMERGENCY NOTIFICATION SYSTEMS Response to Credible Reports of Warning System Malfunction at Highway-Rail...

49 CFR 234.106 - Partial activation.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION GRADE CROSSING SAFETY, INCLUDING SIGNAL SYSTEMS, STATE ACTION PLANS, AND EMERGENCY NOTIFICATION SYSTEMS Response to Credible Reports of Warning System Malfunction at Highway-Rail...

49 CFR 234.101 - Employee notification rules.

Code of Federal Regulations, 2014 CFR

2014-10-01

....101 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION GRADE CROSSING SAFETY, INCLUDING SIGNAL SYSTEMS, STATE ACTION PLANS, AND EMERGENCY NOTIFICATION SYSTEMS Response to Credible Reports of Warning System Malfunction at...

49 CFR 234.107 - False activation.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION GRADE CROSSING SAFETY, INCLUDING SIGNAL SYSTEMS, STATE ACTION PLANS, AND EMERGENCY NOTIFICATION SYSTEMS Response to Credible Reports of Warning System Malfunction at Highway-Rail...

49 CFR 234.105 - Activation failure.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION GRADE CROSSING SAFETY, INCLUDING SIGNAL SYSTEMS, STATE ACTION PLANS, AND EMERGENCY NOTIFICATION SYSTEMS Response to Credible Reports of Warning System Malfunction at Highway-Rail...

49 CFR 234.101 - Employee notification rules.

Code of Federal Regulations, 2012 CFR

2012-10-01

....101 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION GRADE CROSSING SAFETY, INCLUDING SIGNAL SYSTEMS, STATE ACTION PLANS, AND EMERGENCY NOTIFICATION SYSTEMS Response to Credible Reports of Warning System Malfunction at...

49 CFR 234.107 - False activation.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION GRADE CROSSING SAFETY, INCLUDING SIGNAL SYSTEMS, STATE ACTION PLANS, AND EMERGENCY NOTIFICATION SYSTEMS Response to Credible Reports of Warning System Malfunction at Highway-Rail...

49 CFR 234.107 - False activation.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION GRADE CROSSING SAFETY, INCLUDING SIGNAL SYSTEMS, STATE ACTION PLANS, AND EMERGENCY NOTIFICATION SYSTEMS Response to Credible Reports of Warning System Malfunction at Highway-Rail...

49 CFR 234.106 - Partial activation.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION GRADE CROSSING SAFETY, INCLUDING SIGNAL SYSTEMS, STATE ACTION PLANS, AND EMERGENCY NOTIFICATION SYSTEMS Response to Credible Reports of Warning System Malfunction at Highway-Rail...

49 CFR 234.101 - Employee notification rules.

Code of Federal Regulations, 2013 CFR

2013-10-01

....101 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION GRADE CROSSING SAFETY, INCLUDING SIGNAL SYSTEMS, STATE ACTION PLANS, AND EMERGENCY NOTIFICATION SYSTEMS Response to Credible Reports of Warning System Malfunction at...

49 CFR 234.105 - Activation failure.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION GRADE CROSSING SAFETY, INCLUDING SIGNAL SYSTEMS, STATE ACTION PLANS, AND EMERGENCY NOTIFICATION SYSTEMS Response to Credible Reports of Warning System Malfunction at Highway-Rail...

49 CFR 234.109 - Recordkeeping.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION GRADE CROSSING SAFETY, INCLUDING SIGNAL SYSTEMS, STATE ACTION PLANS, AND EMERGENCY NOTIFICATION SYSTEMS Response to Credible Reports of Warning System Malfunction at Highway-Rail...

49 CFR 234.106 - Partial activation.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION GRADE CROSSING SAFETY, INCLUDING SIGNAL SYSTEMS, STATE ACTION PLANS, AND EMERGENCY NOTIFICATION SYSTEMS Response to Credible Reports of Warning System Malfunction at Highway-Rail...

49 CFR 234.105 - Activation failure.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION GRADE CROSSING SAFETY, INCLUDING SIGNAL SYSTEMS, STATE ACTION PLANS, AND EMERGENCY NOTIFICATION SYSTEMS Response to Credible Reports of Warning System Malfunction at Highway-Rail...

A summary and integration of research concerning single pilot IFR operational problems

NASA Technical Reports Server (NTRS)

Chapman, G. C.

1983-01-01

A review of seven research studies pertaining to Single Pilot IFR (SPIFR) operations was performed. Two studies were based on questionnaire surveys; two based on National Transportation Safety Board (NTSB) reports; two were based on Aviation Safety Reporting System (ASRS) incident reports, and one report used event analysis and statistics to forecast problems. The results obtained in each study were extracted and integrated. Results were synthesized and key issues pertaining to SPIFR operations problems were identified. The research that was recommended by the studies and that addressed the key issues is catalogued for each key issue.

Runway Safety Monitor Algorithm for Single and Crossing Runway Incursion Detection and Alerting

NASA Technical Reports Server (NTRS)

Green, David F., Jr.

2006-01-01

The Runway Safety Monitor (RSM) is an aircraft based algorithm for runway incursion detection and alerting that was developed in support of NASA's Runway Incursion Prevention System (RIPS) research conducted under the NASA Aviation Safety and Security Program's Synthetic Vision System project. The RSM algorithm provides warnings of runway incursions in sufficient time for pilots to take evasive action and avoid accidents during landings, takeoffs or when taxiing on the runway. The report documents the RSM software and describes in detail how RSM performs runway incursion detection and alerting functions for NASA RIPS. The report also describes the RIPS flight tests conducted at the Reno/Tahoe International Airport (RNO) and the Wallops Flight Facility (WAL) during July and August of 2004, and the RSM performance results and lessons learned from those flight tests.

FMCSA safety program effectiveness measurement : carrier intervention effectiveness model (CIEM), version 1.1, report for Fiscal Year 2012 interventions.

DOT National Transportation Integrated Search

2016-11-01

The Federal Motor Carrier Safety Administration (FMCSA), in cooperation with the John A. Volpe National Transportation Systems Center (Volpe), has developed a quantitative model to measure the effectiveness of motor carrier interventions in terms of ...

FMCSA Safety Program Effectiveness Measurement: Carrier Intervention Effectiveness Model (CIEM), Version 1.1 Report for Fiscal Year 2014 Interventions

DOT National Transportation Integrated Search

2018-04-01

The Federal Motor Carrier Safety Administration (FMCSA), in cooperation with the John A. Volpe National Transportation Systems Center (Volpe), has developed a quantitative model to measure the effectiveness of motor carrier interventions in terms of ...

FMCSA safety program effectiveness measurement: carrier intervention effectiveness model (CIEM), version 1.1 : report for fiscal year 2013 interventions.

DOT National Transportation Integrated Search

2017-04-01

The Federal Motor Carrier Safety Administration (FMCSA), in cooperation with the John A. Volpe National Transportation Systems Center (Volpe), has developed a quantitative model to measure the effectiveness of motor carrier interventions in terms of ...

FMCSA safety program effectiveness measurement : carrier intervention effectiveness model, version 1.0, summary report for fiscal years 2009, 2010, 2011.

DOT National Transportation Integrated Search

2015-01-01

The Federal Motor Carrier Safety Administration (FMCSA), in cooperation with the John A. Volpe National : Transportation Systems Center (Volpe), has developed a quantitative model to measure the effectiveness of motor : carrier interventions in terms...

FMCSA safety program effectiveness measurement : Carrier Intervention Effectiveness Model (CIEM), Version 1.1, report for fiscal year 2013 interventions.

DOT National Transportation Integrated Search

2017-04-01

The Federal Motor Carrier Safety Administration (FMCSA), in cooperation with the John A. Volpe National Transportation Systems Center (Volpe), has developed a quantitative model to measure the effectiveness of motor carrier interventions in terms of ...