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.

Effects and Satisfaction of Medical Device Safety Information Reporting System Using Electronic Medical Record.

PubMed

Jang, Hye Jung; Choi, Young Deuk; Kim, Nam Hyun

2017-04-01

This paper describes an evaluation study on the effectiveness of developing an in-hospital medical device safety information reporting system for managing safety information, including adverse incident data related to medical devices, following the enactment of the Medical Device Act in Korea. Medical device safety information reports were analyzed for 190 cases that took place prior to the application of a medical device safety information reporting system and during a period when the reporting system was used. Also, questionnaires were used to measure the effectiveness of the medical device safety information reporting system. The analysis was based on the questionnaire responses of 15 reporters who submitted reports in both the pre- and post-reporting system periods. Sixty-two reports were submitted in paper form, but after the system was set up, this number more than doubled to 128 reports in electronic form. In terms of itemized reporting, a total of 45 items were reported. Before the system was used, 23 items had been reported, but this increased to 32 items after the system was put to use. All survey variables of satisfaction received a mean of over 3 points, while positive attitude , potential benefits , and positive benefits all exceeded 4 points, each receiving 4.20, 4.20, and 4.13, respectively. Among the variables, time-consuming and decision-making had the lowest mean values, each receiving 3.53. Satisfaction was found to be high for system quality and user satisfaction , but relatively low for time-consuming and decision-making . We were able to verify that effective reporting and monitoring of adverse incidents and the safety of medical devices can be implemented through the establishment of an in-hospital medical device safety information reporting system that can enhance patient safety and medical device risk management.

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 ...

Analysis of Aviation Safety Reporting System Incident Data Associated with the Technical Challenges of the System-Wide Safety and Assurance Technologies Project

NASA Technical Reports Server (NTRS)

Withrow, Colleen A.; Reveley, Mary S.

2015-01-01

The Aviation Safety Program (AvSP) System-Wide Safety and Assurance Technologies (SSAT) Project asked the AvSP Systems and Portfolio Analysis Team to identify SSAT-related trends. SSAT had four technical challenges: advance safety assurance to enable deployment of NextGen systems; automated discovery of precursors to aviation safety incidents; increasing safety of human-automation interaction by incorporating human performance, and prognostic algorithm design for safety assurance. This report reviews incident data from the NASA Aviation Safety Reporting System (ASRS) for system-component-failure- or-malfunction- (SCFM-) related and human-factor-related incidents for commercial or cargo air carriers (Part 121), commuter airlines (Part 135), and general aviation (Part 91). The data was analyzed by Federal Aviation Regulations (FAR) part, phase of flight, SCFM category, human factor category, and a variety of anomalies and results. There were 38 894 SCFM-related incidents and 83 478 human-factorrelated incidents analyzed between January 1993 and April 2011.

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

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.

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

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).

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.

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).

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.

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.

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

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...

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.

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 ...

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.

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.

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.

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...

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.

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

Lessons learnt from the development of the Patient Safety Incidents Reporting an Learning System for the Spanish National Health System: SiNASP.

PubMed

Vallejo-Gutiérrez, Paula; Bañeres-Amella, Joaquim; Sierra, Eduardo; Casal, Jesús; Agra, Yolanda

2014-01-01

To describe the development process and characteristics of a patient safety incidents reporting system to be implemented in the Spanish National Health System, based on the context and the needs of the different stakeholders. Literature review and analysis of most relevant reporting systems, identification of more than 100 stakeholder's (patients, professionals, regional governments representatives) expectations and requirements, analysis of the legal context, consensus of taxonomy, development of the software and pilot test. Patient Safety Events Reporting and Learning system (Sistema de Notificación y Aprendizajepara la Seguridad del Paciente, SiNASP) is a generic reporting system for all types of incidents related to patient safety, voluntary, confidential, non punitive, anonymous or nominative with anonimization, system oriented, with local analysis of cases and based on the WHO International Classification for Patient Safety. The electronic program has an on-line form for reporting, a software to manage the incidents and improvement plans, and a scoreboard with process indicators to monitor the system. The reporting system has been designed to respond to the needs and expectations identified by the stakeholders, taking into account the lessons learned from the previous notification systems, the characteristics of the National Health System and the existing legal context. The development process presented and the characteristics of the system provide a comprehensive framework that can be used for future deployments of similar patient safety systems. Copyright © 2013 SECA. Published by Elsevier Espana. All rights reserved.

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.

Traffic safety facts 1997 : a compilation of motor vehicle crash data from the fatality analysis reporting system and the general estimates system

DOT National Transportation Integrated Search

1998-11-01

In this annual report, Traffic Safety Facts 1997: A Compilation of Motor Vehicle Crash Data from the Fatality Analysis Reporting System and the General Estimates System, the National Highway Traffic Safety Administration (NHTSA) presents descriptive ...

Traffic safety facts 2007 : 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

In this annual report, Traffic Safety Facts 2007: A Compilation of Motor Vehicle Crash Data from the Fatality : Analysis Reporting System and the General Estimates System, the National Highway Traffic Safety Administration : (NHTSA) presents descript...

Traffic safety facts 2008 : a compilation of motor vehicle crash data from the fatality analysis reporting system and the general estimates system

DOT National Transportation Integrated Search

2008-01-01

In this annual report, Traffic Safety Facts 2008: A Compilation of Motor Vehicle Crash Data from the Fatality Analysis Reporting System and the General Estimates System, the National Highway Traffic Safety Administration (NHTSA) presents descriptive ...

Traffic safety facts 2009 : a compilation of motor vehicle crash data from the fatality analysis reporting system and the general estimates system

DOT National Transportation Integrated Search

2009-01-01

In this annual report, Traffic Safety Facts 2009: A Compilation of Motor Vehicle Crash Data from the Fatality Analysis Reporting System and the General Estimates System, the National Highway Traffic Safety Administration (NHTSA) presents descriptive ...

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.

Review of Safety Reports Involving Electronic Flight Bags.

DOT National Transportation Integrated Search

2010-04-01

Safety events in which Electronic Flight Bags (EFBs) were a factor are reviewed. Relevant reports were obtained from the public Aviation Safety Reporting System (ASRS) database and the National Transportation Safety Board (NTSB) accident report datab...

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.

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...

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...

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.

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.

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

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

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 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...

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...

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.

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.

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.

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

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.

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.

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

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.

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/.

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.

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

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 :...

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...

Patient Safety Learning Systems: A Systematic Review and Qualitative Synthesis.

PubMed

2017-01-01

A patient safety learning system (sometimes called a critical incident reporting system) refers to structured reporting, collation, and analysis of critical incidents. To inform a provincial working group's recommendations for an Ontario Patient Safety Event Learning System, a systematic review was undertaken to determine design features that would optimize its adoption into the health care system and would inform implementation strategies. The objective of this review was to address two research questions: (a) what are the barriers to and facilitators of successful adoption of a patient safety learning system reported by health professionals and (b) what design components maximize successful adoption and implementation? To answer the first question, we used a published systematic review. To answer the second question, we used scoping study methodology. Common barriers reported in the literature by health care professionals included fear of blame, legal penalties, the perception that incident reporting does not improve patient safety, lack of organizational support, inadequate feedback, lack of knowledge about incident reporting systems, and lack of understanding about what constitutes an error. Common facilitators included a non-accusatory environment, the perception that incident reporting improves safety, clarification of the route of reporting and of how the system uses reports, enhanced feedback, role models (such as managers) using and promoting reporting, legislated protection of those who report, ability to report anonymously, education and training opportunities, and clear guidelines on what to report. Components of a patient safety learning system that increased successful adoption and implementation were emphasis on a blame-free culture that encourages reporting and learning, clear guidelines on how and what to report, making sure the system is user-friendly, organizational development support for data analysis to generate meaningful learning outcomes

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.

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

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 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...

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...

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) - 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...

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 ...

System safety checklist Skylab program report

NASA Technical Reports Server (NTRS)

Mcnail, E. M.

1974-01-01

Design criteria statement applicable to a wide variety of flight systems, experiments and other payloads, associated ground support equipment and facility support systems are presented. The document reflects a composite of experience gained throughout the aerospace industry prior to Skylab and additional experience gained during the Skylab Program. It has been prepared to provide current and future program organizations with a broad source of safety-related design criteria and to suggest methods for systematic and progressive application of the criteria beginning with preliminary development of design requirements and specifications. Recognizing the users obligation to shape the checklist to his particular needs, a summary of the historical background, rationale, objectives, development and implementation approach, and benefits based on Skylab experience has been included.

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 ...

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...

NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

1977-01-01

A decline in reports concerning small aircraft was noted; more reports involved transport aircraft, professional pilots, instrument meteorological conditions, and weather problems. A study of 136 reports of operational problems in terminal radar service areas was made. Pilot, controller, and system factors were found to be associated with these occurrences. Information transfer difficulties were prominent. Misunderstandings by pilots, and in some cases by controllers, of the policies and limitations of terminal radar programs were observed.

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

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)

1980-01-01

Knowledge of limitations of the Air Traffic Control system in conflict avoidance capabilities is discussed. Assumptions and expectations held by by airmen regarding the capabilities of the system are presented. Limitations related to communication are described and problems associated with visual approaches, airspace configurations, and airport layouts are discussed. A number of pilot and controller reports illustrative of three typical problem types: occurrences involving pilots who have limited experience; reports describing inflight calls for assistance; and flights in which pilots have declined to use available radar services are presented. Examples of Alert Bulletins and the FAA responses to them are included.

Pre-Departure Clearance (PDC): An Analysis of Aviation Safety Reporting System Reports Concerning PDC Related Errors

NASA Technical Reports Server (NTRS)

Montalyo, Michael L.; Lebacqz, J. Victor (Technical Monitor)

1994-01-01

Airlines operating in the United States are required to operate under instrument flight rules (EFR). Typically, a clearance is issued via voice transmission from clearance delivery at the departing airport. In 1990, the Federal Aviation Administration (FAA) began deployment of the Pre-Departure Clearance (PDC) system at 30 U.S. airports. The PDC system utilizes aeronautical datalink and Aircraft Communication and Reporting System (ACARS) to transmit departure clearances directly to the pilot. An objective of the PDC system is to provide an immediate reduction in voice congestion over the clearance delivery frequency. Participating airports report that this objective has been met. However, preliminary analysis of 42 Aviation Safety Reporting System (ASRS) reports has revealed problems in PDC procedures and formatting which have caused errors in the proper execution of the clearance. It must be acknowledged that this technology, along with other advancements on the flightdeck, is adding more responsibility to the crew and increasing the opportunity for error. The present study uses these findings as a basis for further coding and analysis of an additional 82 reports obtained from an ASRS database search. These reports indicate that clearances are often amended or exceptions are added in order to accommodate local ATC facilities. However, the onboard ACARS is limited in its ability to emphasize or highlight these changes which has resulted in altitude and heading deviations along with increases in ATC workload. Furthermore, few participating airports require any type of PDC receipt confirmation. In fact, 35% of all ASRS reports dealing with PDC's include failure to acquire the PDC at all. Consequently, this study examines pilots' suggestions contained in ASRS reports in order to develop recommendations to airlines and ATC facilities to help reduce the amount of incidents that occur.

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.

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.

NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

1978-01-01

An analytical study of reports relating to cockpit altitude alert systems was performed. A recent change in the Federal Air Regulation permits the system to be modified so that the alerting signal approaching altitude has only a visual component; the auditory signal would continue to be heard if a deviation from an assigned altitude occurred. Failure to observe altitude alert signals and failure to reset the system were the commonest cause of altitude deviations related to this system. Cockpit crew distraction was the most frequent reason for these failures. It was noted by numerous reporters that the presence of altitude alert system made them less aware of altitude; this lack of altitude awareness is discussed. Failures of crew coordination were also noted. It is suggested that although modification of the altitude alert system may be highly desirable in short-haul aircraft, it may not be desirable for long-haul aircraft in which cockpit workloads are much lower for long periods of time. In these cockpits, the aural alert approaching altitudes is perceived as useful and helpful. If the systems are to be modified, it appears that additional emphasis on altitude awareness during recurrent training will be necessary; it is also possible that flight crew operating procedures during climb and descent may need examination with respect to monitoring responsibilities. A selection of alert bulletins and responses to them is presented.

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...

2012 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

Dumont, Alan G.

2012-01-01

This report provides a NASA Range Safety (NRS) overview for current and potential range users. This report contains articles which cover a variety of subject areas, summaries of various NASA Range Safety Program (RSP) 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 2012 NASA Range Safety Annual Report include a program overview and 2012 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.

2010 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

Dumont, Alan G.

2010-01-01

this report provides a NASA Range Safety overview for current and potential range users. This report contains articles which cover a variety of subject areas, summaries of various NASA Range Safety Program activities conducted 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 done in the future. Specific topics discussed in the 2010 NASA Range Safety Annual Report include a program overview and 2010 highlights; Range Safety Training; Range Safety Policy revision; 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. Once again, the web-based format was used to present the annual report.

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),...

System safety education focused on flight safety

NASA Technical Reports Server (NTRS)

Holt, E.

1971-01-01

The measures necessary for achieving higher levels of system safety are analyzed with an eye toward maintaining the combat capability of the Air Force. Several education courses were provided for personnel involved in safety management. Data include: (1) Flight Safety Officer Course, (2) Advanced Safety Program Management, (3) Fundamentals of System Safety, and (4) Quantitative Methods of Safety Analysis.

2009 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

2010-01-01

This year, NASA Range Safety transitioned to a condensed annual report to allow for Secretariat support to the Range Safety Group, Risk Committee. Although much shorter than in previous years, this report contains full-length articles concerning various subject areas, as well as links to past reports. Additionally, summaries from various NASA Range Safety Program activities that took place throughout the year are presented, as well as information on several projects that may have a profound impact on the way business will be done in the future. The sections include a program overview and 2009 highlights; Range Safety Training; Range Safety Policy; Independent Assessments Support to Program Operations at all ranges conducting NASA launch operations; a continuing overview of emerging range safety-related technologies; and status reports from all of the NASA Centers that have Range Safety responsibilities.

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.

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...

2011 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

Dumont, Alan G.

2012-01-01

Welcome to the 2011 edition of the NASA Range Safety Annual Report. Funded by NASA Headquarters, this report provides a NASA Range Safety overview for current and potential range users. As is typical with odd year editions, this is an abbreviated Range Safety Annual Report providing updates and links to full articles from the previous year's report. It also provides more complete articles covering new subject areas, summaries of various NASA Range Safety Program activities conducted during the past year, and information on several projects that may have a profound impact on the way business will be done in the future. Specific topics discussed and updated in the 2011 NASA Range Safety Annual Report include a program overview and 2011 highlights; Range Safety Training; Range Safety Policy revision; 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. Once again the web-based format was used to present the annual report. We continually receive positive feedback on the web-based edition and hope you enjoy this year's product as well. As is the case each year, contributors to this report are too numerous to mention, but we thank individuals from the NASA Centers, the Department of Defense, and civilian organizations for their contributions. In conclusion, it has been a busy and productive year. I'd like to extend a personal Thank You to everyone who contributed to make this year a successful one, and I look forward to working with all of you in the upcoming year.

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.

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

Software Safety Risk in Legacy Safety-Critical Computer Systems

NASA Technical Reports Server (NTRS)

Hill, Janice L.; Baggs, Rhoda

2007-01-01

Safety Standards contain technical and process-oriented safety requirements. Technical requirements are those such as "must work" and "must not work" functions in the system. Process-Oriented requirements are software engineering and safety management process requirements. Address the system perspective and some cover just software in the system > NASA-STD-8719.13B Software Safety Standard is the current standard of interest. NASA programs/projects will have their own set of safety requirements derived from the standard. Safety Cases: a) Documented demonstration that a system complies with the specified safety requirements. b) Evidence is gathered on the integrity of the system and put forward as an argued case. [Gardener (ed.)] c) Problems occur when trying to meet safety standards, and thus make retrospective safety cases, in legacy safety-critical computer systems.

Exploring relationships between hospital patient safety culture and Consumer Reports safety scores.

PubMed

Smith, Scott Alan; Yount, Naomi; Sorra, Joann

2017-02-16

A number of private and public companies calculate and publish proprietary hospital patient safety scores based on publicly available quality measures initially reported by the U.S. federal government. This study examines whether patient safety culture perceptions of U.S. hospital staff in a large national survey are related to publicly reported patient safety ratings of hospitals. The Agency for Healthcare Research and Quality Hospital Survey on Patient Safety Culture (Hospital SOPS) assesses provider and staff perceptions of hospital patient safety culture. Consumer Reports (CR), a U.S. based non-profit organization, calculates and shares with its subscribers a Hospital Safety Score calculated annually from patient experience survey data and outcomes data gathered from federal databases. Linking data collected during similar time periods, we analyzed relationships between staff perceptions of patient safety culture composites and the CR Hospital Safety Score and its five components using multiple multivariate linear regressions. We analyzed data from 164 hospitals, with patient safety culture survey responses from 140,316 providers and staff, with an average of 856 completed surveys per hospital and an average response rate per hospital of 56%. Higher overall Hospital SOPS composite average scores were significantly associated with higher overall CR Hospital Safety Scores (β = 0.24, p < 0.05). For 10 of the 12 Hospital SOPS composites, higher patient safety culture scores were associated with higher CR patient experience scores on communication about medications and discharge. This study found a relationship between hospital staff perceptions of patient safety culture and the Consumer Reports Hospital Safety Score, which is a composite of patient experience and outcomes data from federal databases. As hospital managers allocate resources to improve patient safety culture within their organizations, their efforts may also indirectly improve consumer

Software Safety Risk in Legacy Safety-Critical Computer Systems

NASA Technical Reports Server (NTRS)

Hill, Janice; Baggs, Rhoda

2007-01-01

Safety-critical computer systems must be engineered to meet system and software safety requirements. For legacy safety-critical computer systems, software safety requirements may not have been formally specified during development. When process-oriented software safety requirements are levied on a legacy system after the fact, where software development artifacts don't exist or are incomplete, the question becomes 'how can this be done?' The risks associated with only meeting certain software safety requirements in a legacy safety-critical computer system must be addressed should such systems be selected as candidates for reuse. This paper proposes a method for ascertaining formally, a software safety risk assessment, that provides measurements for software safety for legacy systems which may or may not have a suite of software engineering documentation that is now normally required. It relies upon the NASA Software Safety Standard, risk assessment methods based upon the Taxonomy-Based Questionnaire, and the application of reverse engineering CASE tools to produce original design documents for legacy systems.

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.

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

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.

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.

TA-55 Final Safety Analysis Report Comparison Document and DOE Safety Evaluation Report Requirements

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

Alan Bond

2001-04-01

This document provides an overview of changes to the currently approved TA-55 Final Safety Analysis Report (FSAR) that are included in the upgraded FSAR. The DOE Safety Evaluation Report (SER) requirements that are incorporated into the upgraded FSAR are briefly discussed to provide the starting point in the FSAR with respect to the SER requirements.

NASA System Safety Handbook. Volume 2: System Safety Concepts, Guidelines, and Implementation Examples

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Benjamin, Allan; Everett, Christopher; Feather, Martin; Rutledge, Peter; Sen, Dev; Youngblood, Robert

2015-01-01

This is the second of two volumes that collectively comprise the NASA System Safety Handbook. Volume 1 (NASASP-210-580) was prepared for the purpose of presenting the overall framework for System Safety and for providing the general concepts needed to implement the framework. Volume 2 provides guidance for implementing these concepts as an integral part of systems engineering and risk management. This guidance addresses the following functional areas: 1.The development of objectives that collectively define adequate safety for a system, and the safety requirements derived from these objectives that are levied on the system. 2.The conduct of system safety activities, performed to meet the safety requirements, with specific emphasis on the conduct of integrated safety analysis (ISA) as a fundamental means by which systems engineering and risk management decisions are risk-informed. 3.The development of a risk-informed safety case (RISC) at major milestone reviews to argue that the systems safety objectives are satisfied (and therefore that the system is adequately safe). 4.The evaluation of the RISC (including supporting evidence) using a defined set of evaluation criteria, to assess the veracity of the claims made therein in order to support risk acceptance decisions.

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.

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.

Space engine safety system

NASA Technical Reports Server (NTRS)

Maul, William A.; Meyer, Claudia M.

1991-01-01

A rocket engine safety system was designed to initiate control procedures to minimize damage to the engine or vehicle or test stand in the event of an engine failure. The features and the implementation issues associated with rocket engine safety systems are discussed, as well as the specific concerns of safety systems applied to a space-based engine and long duration space missions. Examples of safety system features and architectures are given, based on recent safety monitoring investigations conducted for the Space Shuttle Main Engine and for future liquid rocket engines. Also, the general design and implementation process for rocket engine safety systems is presented.

The Interagency Nuclear Safety Review Panel's Galileo safety evaluation report

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

Nelson, R.C.; Gray, L.B.; Huff, D.A.

The safety evaluation report (SER) for Galileo was prepared by the Interagency Nuclear Safety Review Panel (INSRP) coordinators in accordance with Presidential directive/National Security Council memorandum 25. The INSRP consists of three coordinators appointed by their respective agencies, the Department of Defense, the Department of Energy (DOE), and the National Aeronautics and Space Administration (NASA). These individuals are independent of the program being evaluated and depend on independent experts drawn from the national technical community to serve on the five INSRP subpanels. The Galileo SER is based on input provided by the NASA Galileo Program Office, review and assessment ofmore » the final safety analysis report prepared by the Office of Special Applications of the DOE under a memorandum of understanding between NASA and the DOE, as well as other related data and analyses. The SER was prepared for use by the agencies and the Office of Science and Technology Policy, Executive Office of the Present for use in their launch decision-making process. Although more than 20 nuclear-powered space missions have been previously reviewed via the INSRP process, the Galileo review constituted the first review of a nuclear power source associated with launch aboard the Space Transportation System.« less

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...

Learning and feedback from the Danish patient safety incident reporting system can be improved.

PubMed

Moeller, Anders Damgaard; Rasmussen, Kurt; Nielsen, Kent Jacob

2016-06-01

The perceived usefulness of incident reporting systems is an important motivational factor for reporting. The usefulness may be facilitated by well-established feedback mechanisms and by learning processes. The aim of this study was to investigate how feedback mechanisms and learning processes were implemented at four Danish hospital units all located in one of the five Danish regions. Based on the concepts of feedback and learning from incident processes, a questionnaire was developed and distributed to 335 patient safety representatives from 200 departments at four Danish hospital units in one of the five Danish regions. The study showed that external reporters were rarely contacted for dialogue, grouped front-line staff were sparsely involved in the learning process, few evaluated the effectiveness of implemented interventions and personal factors were frequently perceived as a primary contributory factor to these incidents. In contrast, the patient safety representatives perceived their competencies as sufficient for the job, internal reporters were often contacted for dialogue, evaluation was widely used and management supported the work with incident reports. The results of the study identified several shortcomings in the implementation of learning processes and feedback mechanisms. The apparent existence of a person-focused approach stands out as an element of notice. The insufficient implementation we observed indicates that there is room for improvement in the efforts made to maximise learning from incidents in the investigated population. not relevant. not relevant.

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.

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.

21 CFR 314.540 - Postmarketing safety reporting.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Postmarketing safety reporting. 314.540 Section... New Drugs for Serious or Life-Threatening Illnesses § 314.540 Postmarketing safety reporting. Drug products approved under this program are subject to the postmarketing recordkeeping and safety reporting...

NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

1978-01-01

Reports describing various types of communication problems are presented along with summaries dealing with judgment and decision making. Concerns relating to the ground proximity warning system are summarized and several examples of true terrain proximity warnings are provided. An analytic study of reports relating to profile descents was performed. Problems were found to be associated with charting and graphic presentation of the descents, with lack of uniformity of the descent procedures among facilities using them, and with the flight crew workload engendered by profile descents, particularly when additional requirements are interposed by air traffic control during the execution of the profiles. A selection of alert bulletins and responses to them were reviewed.

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.

49 CFR 191.23 - Reporting safety-related conditions.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Reporting safety-related conditions. 191.23... HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE; ANNUAL REPORTS, INCIDENT REPORTS, AND SAFETY-RELATED...

Information Extraction for System-Software Safety Analysis: Calendar Year 2007 Year-End Report

NASA Technical Reports Server (NTRS)

Malin, Jane T.

2008-01-01

This annual report describes work to integrate a set of tools to support early model-based analysis of failures and hazards due to system-software interactions. The tools perform and assist analysts in the following tasks: 1) extract model parts from text for architecture and safety/hazard models; 2) combine the parts with library information to develop the models for visualization and analysis; 3) perform graph analysis on the models to identify possible paths from hazard sources to vulnerable entities and functions, in nominal and anomalous system-software configurations; 4) perform discrete-time-based simulation on the models to investigate scenarios where these paths may play a role in failures and mishaps; and 5) identify resulting candidate scenarios for software integration testing. This paper describes new challenges in a NASA abort system case, and enhancements made to develop the integrated tool set.

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…

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 - ...

NASA System Safety Handbook. Volume 1; System Safety Framework and Concepts for Implementation

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Benjamin, Allan; Everett, Christopher; Smith, Curtis; Stamatelatos, Michael; Youngblood, Robert

2011-01-01

System safety assessment is defined in NPR 8715.3C, NASA General Safety Program Requirements as a disciplined, systematic approach to the analysis of risks resulting from hazards that can affect humans, the environment, and mission assets. Achievement of the highest practicable degree of system safety is one of NASA's highest priorities. Traditionally, system safety assessment at NASA and elsewhere has focused on the application of a set of safety analysis tools to identify safety risks and formulate effective controls.1 Familiar tools used for this purpose include various forms of hazard analyses, failure modes and effects analyses, and probabilistic safety assessment (commonly also referred to as probabilistic risk assessment (PRA)). In the past, it has been assumed that to show that a system is safe, it is sufficient to provide assurance that the process for identifying the hazards has been as comprehensive as possible and that each identified hazard has one or more associated controls. The NASA Aerospace Safety Advisory Panel (ASAP) has made several statements in its annual reports supporting a more holistic approach. In 2006, it recommended that "... a comprehensive risk assessment, communication and acceptance process be implemented to ensure that overall launch risk is considered in an integrated and consistent manner." In 2009, it advocated for "... a process for using a risk-informed design approach to produce a design that is optimally and sufficiently safe." As a rationale for the latter advocacy, it stated that "... the ASAP applauds switching to a performance-based approach because it emphasizes early risk identification to guide designs, thus enabling creative design approaches that might be more efficient, safer, or both." For purposes of this preface, it is worth mentioning three areas where the handbook emphasizes a more holistic type of thinking. First, the handbook takes the position that it is important to not just focus on risk on an individual

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

Systemic safety project selection tool.

DOT National Transportation Integrated Search

2013-07-01

"The Systemic Safety Project Selection Tool presents a process for incorporating systemic safety planning into traditional safety management processes. The Systemic Tool provides a step-by-step process for conducting systemic safety analysis; conside...

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…

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

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.

2008 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

Lamoreaux, Richard W.

2008-01-01

Welcome to the 2008 edition of the NASA Range Safety Annual Report. Funded by NASA Headquarters, this report provides a NASA Range Safety overview for current and potential range users. This year, along with full length articles concerning various subject areas, we have provided updates to standard subjects with links back to the 2007 original article. Additionally, we present summaries from the various NASA Range Safety Program activities that took place throughout the year, as well as information on several special projects that may have a profound impact on the way we will do business in the future. The sections include a program overview and 2008 highlights of Range Safety Training; Range Safety Policy; Independent Assessments and Common Risk Analysis Tools Development; Support to Program Operations at all ranges conducting NASA launch operations; a continuing overview of emerging Range Safety-related technologies; Special Interests Items that include recent changes in the ELV Payload Safety Program and the VAS explosive siting study; and status reports from all of the NASA Centers that have Range Safety responsibilities. As is the case each year, contributors to this report are too numerous to mention, but we thank individuals from the NASA Centers, the Department of Defense, and civilian organizations for their contributions. We have made a great effort to include the most current information available. We recommend that this report be used only for guidance and that the validity and accuracy of all articles be verified for updates. This is the third year we have utilized this web-based format for the annual report. We continually receive positive feedback on the web-based edition, and we hope you enjoy this year's product as well. It has been a very busy and productive year on many fronts as you will note as you review this report. Thank you to everyone who contributed to make this year a successful one, and I look forward to working with all of you in the

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.

How Effective Are Incident-Reporting Systems for Improving Patient Safety? A Systematic Literature Review

PubMed Central

Stavropoulou, Charitini; Doherty, Carole; Tosey, Paul

2015-01-01

Context Incident-reporting systems (IRSs) are used to gather information about patient safety incidents. Despite the financial burden they imply, however, little is known about their effectiveness. This article systematically reviews the effectiveness of IRSs as a method of improving patient safety through organizational learning. Methods Our systematic literature review identified 2 groups of studies: (1) those comparing the effectiveness of IRSs with other methods of error reporting and (2) those examining the effectiveness of IRSs on settings, structures, and outcomes in regard to improving patient safety. We used thematic analysis to compare the effectiveness of IRSs with other methods and to synthesize what was effective, where, and why. Then, to assess the evidence concerning the ability of IRSs to facilitate organizational learning, we analyzed studies using the concepts of single-loop and double-loop learning. Findings In total, we identified 43 studies, 8 that compared IRSs with other methods and 35 that explored the effectiveness of IRSs on settings, structures, and outcomes. We did not find strong evidence that IRSs performed better than other methods. We did find some evidence of single-loop learning, that is, changes to clinical settings or processes as a consequence of learning from IRSs, but little evidence of either improvements in outcomes or changes in the latent managerial factors involved in error production. In addition, there was insubstantial evidence of IRSs enabling double-loop learning, that is, a cultural change or a change in mind-set. Conclusions The results indicate that IRSs could be more effective if the criteria for what counts as an incident were explicit, they were owned and led by clinical teams rather than centralized hospital departments, and they were embedded within organizations as part of wider safety programs. PMID:26626987

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.

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.

Traceability of Software Safety Requirements in Legacy Safety Critical Systems

NASA Technical Reports Server (NTRS)

Hill, Janice L.

2007-01-01

How can traceability of software safety requirements be created for legacy safety critical systems? Requirements in safety standards are imposed most times during contract negotiations. On the other hand, there are instances where safety standards are levied on legacy safety critical systems, some of which may be considered for reuse for new applications. Safety standards often specify that software development documentation include process-oriented and technical safety requirements, and also require that system and software safety analyses are performed supporting technical safety requirements implementation. So what can be done if the requisite documents for establishing and maintaining safety requirements traceability are not available?

1995 Bicycle and Pedestrian Safety Report

DOT National Transportation Integrated Search

1995-03-01

This report provides a review of the current data on bicycle and pedestrian : safety across the United States, finding that safety and education : programs could significantly improve bicycle and pedestrian safety in the : Dallas-Fort Worth Metropoli...

NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

1978-01-01

The study deals with 165 inadvertent operations on or into inappropriate portions of the aircraft areas at controlled airports. Pilot-initiated and controller-initiated incursions are described and discussed. It was found that a majority of the pilot-initiated occurrences involved operation without a clearance; controller-initiated occurrences usually involved failure to maintain assured separation. The factors associated with these occurrences are analyzed. It appears that a major problem in these occurrences is inadequate coordination among the various system participants. Reasons for this, and some possible solutions to various aspects of the problem, are discussed. A sample of reports from pilots and controllers is presented. These relate to undesired occurrences in air transport, general aviation, and air traffic control operations; to ATC coordination problems; and to a recurrent problem in ASRS reports, parachuting operations. A sample of alert bulletins and responses to them is presented.

Local Food Systems Food Safety Concerns.

PubMed

Chapman, Benjamin; Gunter, Chris

2018-04-01

Foodborne disease causes an estimated 48 million illnesses and 3,000 deaths annually (Scallan E, et al., Emerg Infect Dis 17:7-15, 2011), with U.S. economic costs estimated at $152 billion to $1.4 trillion annually (Roberts T, Am J Agric Econ 89:1183-1188, 2007; Scharff RL, http://www.pewtrusts.org/en/research-and-analysis/reports/0001/01/01/healthrelated-costs-from-foodborne-illness-in-the-united-states, 2010). An increasing number of these illnesses are associated with fresh fruits and vegetables. An analysis of outbreaks from 1990 to 2003 found that 12% of outbreaks and 20% of outbreak-related illnesses were associated with produce (Klein S, Smith DeWaal CS, Center for Science in the Public Interest, https://cspinet.org/sites/default/files/attachment/ddreport.pdf, June 2008; Lynch M, Tauxe R, Hedberg C, Epidemiol Infect 137:307-315, 2009). These food safety problems have resulted in various stakeholders recommending the shift to a more preventative and risk-based food safety system. A modern risk-based food safety system takes a farm-to-fork preventative approach to food safety and relies on the proactive collection and analysis of data to better understand potential hazards and risk factors, to design and evaluate interventions, and to prioritize prevention efforts. Such a system focuses limited resources at the points in the food system with the likelihood of having greatest benefit to public health. As shared kitchens, food hubs, and local food systems such as community supported agriculture are becoming more prevalent throughout the United States, so are foodborne illness outbreaks at these locations. At these locations, many with limited resources, food safety methods of prevention are rarely the main focus. This lack of focus on food safety knowledge is why a growing number of foodborne illness outbreaks are occurring at these locations.

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...

Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?

PubMed

Härmark, Linda; Raine, June; Leufkens, Hubert; Edwards, I Ralph; Moretti, Ugo; Sarinic, Viola Macolic; Kant, Agnes

2016-10-01

The role of patients as key contributors in pharmacovigilance was acknowledged in the new EU pharmacovigilance legislation. This contains several efforts to increase the involvement of the general public, including making patient adverse drug reaction (ADR) reporting systems mandatory. Three years have passed since the legislation was introduced and the key question is: does pharmacovigilance yet make optimal use of patient-reported safety information? Independent research has shown beyond doubt that patients make an important contribution to pharmacovigilance signal detection. Patient reports provide first-hand information about the suspected ADR and the circumstances under which it occurred, including medication errors, quality failures, and 'near misses'. Patient-reported safety information leads to a better understanding of the patient's experiences of the ADR. Patients are better at explaining the nature, personal significance and consequences of ADRs than healthcare professionals' reports on similar associations and they give more detailed information regarding quality of life including psychological effects and effects on everyday tasks. Current methods used in pharmacovigilance need to optimise use of the information reported from patients. To make the most of information from patients, the systems we use for collecting, coding and recording patient-reported information and the methodologies applied for signal detection and assessment need to be further developed, such as a patient-specific form, development of a severity grading and evolution of the database structure and the signal detection methods applied. It is time for a renaissance of pharmacovigilance.

Autonomous Flight Safety System

NASA Technical Reports Server (NTRS)

Ferrell, Bob; Santuro, Steve; Simpson, James; Zoerner, Roger; Bull, Barton; Lanzi, Jim

2004-01-01

Autonomous Flight Safety System (AFSS) is an independent flight safety system designed for small to medium sized expendable launch vehicles launching from or needing range safety protection while overlying relatively remote locations. AFSS replaces the need for a man-in-the-loop to make decisions for flight termination. AFSS could also serve as the prototype for an autonomous manned flight crew escape advisory system. AFSS utilizes onboard sensors and processors to emulate the human decision-making process using rule-based software logic and can dramatically reduce safety response time during critical launch phases. The Range Safety flight path nominal trajectory, its deviation allowances, limit zones and other flight safety rules are stored in the onboard computers. Position, velocity and attitude data obtained from onboard global positioning system (GPS) and inertial navigation system (INS) sensors are compared with these rules to determine the appropriate action to ensure that people and property are not jeopardized. The final system will be fully redundant and independent with multiple processors, sensors, and dead man switches to prevent inadvertent flight termination. AFSS is currently in Phase III which includes updated algorithms, integrated GPS/INS sensors, large scale simulation testing and initial aircraft flight testing.

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.

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...

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

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 ...

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

PubMed

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

2016-05-01

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

Transportation Safety Information Report : 1982 Annual Summary

DOT National Transportation Integrated Search

1983-01-01

The "Transportation Safety Information Report" is a compendium of selected national-level transportation safety statistics for all modes of transportation. The report presents and compares data for transportation fatalities, accidents, and injuries f...

Transportation Safety Information Report : 1987 Annual Summary

DOT National Transportation Integrated Search

1988-01-01

The "Transportation Safety Information Report" is a compendium of selected national-level transportation safety statistics for all modes of transportation. The report presents and compares data for transportation fatalities, accidents, and injuries f...

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

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

Transportation Safety Information Report : Second Quarter 1984

DOT National Transportation Integrated Search

1984-01-01

The "Transportation Safety Information Report" is a compendium of selected national-level transportation safety statistics for all modes of transportation. The report presents and compares data on a monthly and quarterly basis for transportation fata...

Transportation Safety Information Report : Second Quarter 1985

DOT National Transportation Integrated Search

1985-10-01

The "Transportation Safety Information Report" is a compendium of selected national-level transportation safety statistics for all modes of transportation. The report presents and compares data on a monthly and quarterly basis for transportation fata...

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.

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...

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...

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...

Air Data Report Improves Flight Safety

NASA Technical Reports Server (NTRS)

2007-01-01

NASA's Aviation Safety Program in the NASA Aeronautics Research Mission Directorate, which seeks to make aviation safer by developing tools for flight data analysis and interpretation and then by transferring these tools to the aviation industry, sponsored the development of Morning Report software. The software, created at Ames Research Center with the assistance of the Pacific Northwest National Laboratory, seeks to detect atypicalities without any predefined parameters-it spots deviations and highlights them. In 2004, Sagem Avionics Inc. entered a licensing agreement with NASA for the commercialization of the Morning Report software, and also licensed the NASA Aviation Data Integration System (ADIS) tool, which allows for the integration of data from disparate sources into the flight data analysis process. Sagem Avionics incorporated the Morning Report tool into its AGS product, a comprehensive flight operations monitoring system that helps users detect irregular or divergent practices, technical flaws, and problems that might develop when aircraft operate outside of normal procedures. Sagem developed AGS in collaboration with airlines, so that the system takes into account their technical evolutions and needs, and each airline is able to easily perform specific treatments and to build its own flight data analysis system. Further, the AGS is designed to support any aircraft and flight data recorders.

The procedure safety system

NASA Technical Reports Server (NTRS)

Obrien, Maureen E.

1990-01-01

Telerobotic operations, whether under autonomous or teleoperated control, require a much more sophisticated safety system than that needed for most industrial applications. Industrial robots generally perform very repetitive tasks in a controlled, static environment. The safety system in that case can be as simple as shutting down the robot if a human enters the work area, or even simply building a cage around the work space. Telerobotic operations, however, will take place in a dynamic, sometimes unpredictable environment, and will involve complicated and perhaps unrehearsed manipulations. This creates a much greater potential for damage to the robot or objects in its vicinity. The Procedural Safety System (PSS) collects data from external sensors and the robot, then processes it through an expert system shell to determine whether an unsafe condition or potential unsafe condition exists. Unsafe conditions could include exceeding velocity, acceleration, torque, or joint limits, imminent collision, exceeding temperature limits, and robot or sensor component failure. If a threat to safety exists, the operator is warned. If the threat is serious enough, the robot is halted. The PSS, therefore, uses expert system technology to enhance safety thus reducing operator work load, allowing him/her to focus on performing the task at hand without the distraction of worrying about violating safety criteria.

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.

Medication safety in the home care setting: Development and piloting of a Critical Incident Reporting System

PubMed

Meyer-Massetti, Carla; Krummenacher, Evelyne; Hedinger-Grogg, Barbara; Luterbacher, Stephan; Hersberger, Kurt E

2016-09-01

Background: While drug-related problems are among the most frequent adverse events in health care, little is known about their type and prevalence in home care in the current literature. The use of a Critical Incident Reporting System (CIRS), known as an economic and efficient tool to record medication errors for subsequent analysis, is widely implemented in inpatient care, but less established in ambulatory care. Recommendations on a possible format are scarce. A manual CIRS was developed based on the literature and subsequently piloted and implemented in a Swiss home care organization. Aim: The aim of this work was to implement a critical incident reporting system specifically for medication safety in home care. Results: The final CIRS form was well accepted among staff. Requiring limited resources, it allowed preliminary identification and trending of medication errors in home care. The most frequent error reports addressed medication preparation at the patients’ home, encompassing the following errors: omission (30 %), wrong dose (17.5 %) and wrong time (15 %). The most frequent underlying causes were related to working conditions (37.9 %), lacking attention (68.2 %), time pressure (22.7 %) and interruptions by patients (9.1 %). Conclusions: A manual CIRS allowed efficient data collection and subsequent analysis of medication errors in order to plan future interventions for improvement of medication safety. The development of an electronic CIRS would allow a reduction of the expenditure of time regarding data collection and analysis. In addition, it would favour the development of a national CIRS network among home care institutions.

Adverse Event Reporting: Harnessing Residents to Improve Patient Safety.

PubMed

Tevis, Sarah E; Schmocker, Ryan K; Wetterneck, Tosha B

2017-10-13

Reporting of adverse and near miss events are essential to identify system level targets to improve patient safety. Resident physicians historically report few events despite their role as front-line patient care providers. We sought to evaluate barriers to adverse event reporting in an effort to improve reporting. Our main outcomes were as follows: resident attitudes about event reporting and the frequency of event reporting before and after interventions to address reporting barriers. We surveyed first year residents regarding barriers to adverse event reporting and used this input to construct a fishbone diagram listing barriers to reporting. Barriers were addressed, and resident event reporting was compared before and after efforts were made to reduce obstacles to reporting. First year residents (97%) recognized the importance of submitting event reports; however, the majority (85%) had not submitted an event report in the first 6 months of residency. Only 7% of residents specified that they had not witnessed an adverse event in 6 months, whereas one third had witnessed 10 or more events. The main barriers were as follows: lack of knowledge about how to submit events (38%) and lack of time to submit reports (35%). After improving resident education around event reporting and simplifying the reporting process, resident event reporting increased 230% (68 to 154 annual reports, P = 0.025). We were able to significantly increase resident event reporting by educating residents about adverse events and near misses and addressing the primary barriers to event reporting. Moving forward, we will continue annual resident education about patient safety, focus on improving feedback to residents who submit reports, and empower senior residents to act as role models to junior residents in patient safety initiatives.

Patient Drug Safety Reporting: Diabetes Patients' Perceptions of Drug Safety and How to Improve Reporting of Adverse Events and Product Complaints.

PubMed

Patel, Puja; Spears, David; Eriksen, Betina Østergaard; Lollike, Karsten; Sacco, Michael

2018-03-01

Global health care manufacturer Novo Nordisk commissioned research regarding awareness of drug safety department activities and potential to increase patient feedback. Objectives were to examine patients' knowledge of pharmaceutical manufacturers' responsibilities and efforts regarding drug safety, their perceptions and experiences related to these efforts, and how these factors influence their thoughts and behaviors. Data were collected before and after respondents read a description of a drug safety department and its practices. We conducted quantitative survey research across 608 health care consumers receiving treatment for diabetes in the United States, Germany, United Kingdom, and Italy. This research validated initial, exploratory qualitative research (across 40 comparable consumers from the same countries) which served to guide design of the larger study. Before reading a drug safety department description, 55% of respondents were unaware these departments collect safety information on products and patients. After reading the description, 34% reported the department does more than they expected to ensure drug safety, and 56% reported "more confidence" in the industry as a whole. Further, 66% reported themselves more likely to report an adverse event or product complaint, and 60% reported that they were more likely to contact a drug safety department with questions. The most preferred communication methods were websites/online forums (39%), email (27%), and telephone (25%). Learning about drug safety departments elevates consumers' confidence in manufacturers' safety efforts and establishes potential for patients to engage in increased self-monitoring and reporting. Study results reveal potentially actionable insights for the industry across patient and physician programs and communications.

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.

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;

Manned space flight nuclear system safety. Volume 6: Space base nuclear system safety plan

NASA Technical Reports Server (NTRS)

1972-01-01

A qualitative identification of the steps required to assure the incorporation of radiological system safety principles and objectives into all phases of a manned space base program are presented. Specific areas of emphasis include: (1) radiological program management, (2) nuclear system safety plan implementation, (3) impact on program, and (4) summary of the key operation and design guidelines and requirements. The plan clearly indicates the necessity of considering and implementing radiological system safety recommendations as early as possible in the development cycle to assure maximum safety and minimize the impact on design and mission plans.

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.

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.

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.

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.

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.

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.

Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

PubMed

2010-09-29

The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

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

PubMed Central

2011-01-01

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

Safety of High Speed Magnetic Levitation Transportation Systems: Preliminary Safety Review of the Transrapid Maglev System

DOT National Transportation Integrated Search

1990-11-01

The safety of various magnetically levitated trains under development for possible : implementation in the United States is of direct concern to the Federal Railroad : Administration. This report, one in a series of planned reports on maglev safety, ...

Meeting Report: 2015 PDA Virus & TSE Safety Forum.

PubMed

Willkommen, Hannelore; Blümel, Johannes; Brorson, Kurt; Chen, Dayue; Chen, Qi; Gröner, Albrecht; Kreil, Thomas R; Ruffing, Michel; Ruiz, Sol; Scott, Dorothy; Silvester, Glenda

2016-01-01

The report provides a summary of the presentations at the Virus & TSE Safety Forum 2015 organized by the Parenteral Drug Association (PDA) and held in Cascais, Portugal, from 9 to 11 June, 2015. As with previous conferences of this series, the PDA Virus & TSE Safety Forum 2015 provided an excellent forum for the exchange of information and opinions between the industry, research organizations, and regulatory bodies. Regulatory updates on virus and TSE safety aspects illustrating current topics of discussion at regulatory agencies in Europe and the United States were provided; the conference covered emerging viruses and new virus detection systems that may be used for the investigation of human pathogenic viruses as well as the virus safety of cell substrates and of raw material of ovine/caprine or human origin. Progress of development and use of next-generation sequencing methods was shown by several examples. Virus clearance data illustrating the effectiveness of inactivation or removal methods were presented and data provided giving insight into the mechanism of action of these technologies. In the transmissible spongiform encephalopathy (TSE) part of the conference, the epidemiology of variant Creutzfeldt-Jakob disease was reviewed and an overview about diagnostic tests provided; current thinking about the spread and propagation of prions was presented and the inactivation of prions by disinfection (equipment) and in production of bovine-derived reagents (heparin) shown. The current report provides an overview about the outcomes of the 2015 PDA Virus & TSE Safety Forum, a unique event in this field. © PDA, Inc. 2016.

NASA Safety Manual. Volume 3: System Safety

NASA Technical Reports Server (NTRS)

1970-01-01

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

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...

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.

[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.

Safety of railroad passenger vehicle dynamics : final summary report

DOT National Transportation Integrated Search

2002-07-01

This report is a summary of all the work done by Foster-Miller on the passenger rail vehicle dynamic safety under the contract awarded by the FRA. The report presents key issues and findings in the safety assessments and a safety assessment methodolo...

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 ...

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

NASA Technical Reports Server (NTRS)

Malin, Jane T.

2009-01-01

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

77 FR 70409 - System Safety Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-26

...-0060, Notice No. 2] 2130-AC31 System Safety Program AGENCY: Federal Railroad Administration (FRA... passenger railroads to develop and implement a system safety program (SSP) to improve the safety of their... Division, U.S. Department of Transportation, Federal Railroad Administration, Office of Railroad Safety...

Safety awareness, pilot education, and incident reporting programs

NASA Technical Reports Server (NTRS)

Enders, J.

1984-01-01

Education in safety awareness, pilot training, and accident reporting is discussed. Safety awareness and risk management are examined. Both quantitative and qualitive risk management are explored. Information dissemination on safety is considered.

Safety and Efficacy of Lacrimal Drainage System Plugs for Dry Eye Syndrome: A Report by the American Academy of Ophthalmology.

PubMed

Marcet, Marcus M; Shtein, Roni M; Bradley, Elizabeth A; Deng, Sophie X; Meyer, Dale R; Bilyk, Jurij R; Yen, Michael T; Lee, W Barry; Mawn, Louise A

2015-08-01

To review the published literature assessing the efficacy and safety of lacrimal drainage system plug insertion for dry eye in adults. Literature searches of the PubMed and Cochrane Library databases were last conducted on March 9, 2015, without date restrictions and were limited to English language abstracts. The searches retrieved 309 unique citations. The primary authors reviewed the titles and abstracts. Inclusion criteria specified reports that provided original data on plugs for the treatment of dry eyes in at least 25 patients. Fifty-three studies of potential relevance were assigned to full-text review. The 27 studies that met the inclusion criteria underwent data abstraction by the panels. Abstracted data included study characteristics, patient characteristics, plug type, insertion technique, treatment response, and safety information. All studies were observational and rated by a methodologist as level II or III evidence. The plugs included punctal, intracanalicular, and dissolving types. Fifteen studies reported metrics of improvement in dry eye symptoms, ocular-surface status, artificial tear use, contact lens comfort, and tear break-up time. Twenty-five studies included safety data. Plug placement resulted in ≥50% improvement of symptoms, improvement in ocular-surface health, reduction in artificial tear use, and improved contact lens comfort in patients with dry eye. Serious complications from plugs were infrequent. Plug loss was the most commonly reported problem with punctal plugs, occurring on average in 40% of patients. Overall, among all plug types, approximately 9% of patients experienced epiphora and 10% required removal because of irritation from the plugs. Canaliculitis was the most commonly reported problem for intracanalicular plugs and occurred in approximately 8% of patients. Other complications were reported in less than 4% of patients on average and included tearing, discomfort, pyogenic granuloma, and dacryocystitis. On the basis of

Fluor Daniel Hanford Inc. integrated safety management system phase 1 verification final report

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

PARSONS, J.E.

1999-10-28

The purpose of this review is to verify the adequacy of documentation as submitted to the Approval Authority by Fluor Daniel Hanford, Inc. (FDH). This review is not only a review of the Integrated Safety Management System (ISMS) System Description documentation, but is also a review of the procedures, policies, and manuals of practice used to implement safety management in an environment of organizational restructuring. The FDH ISMS should support the Hanford Strategic Plan (DOE-RL 1996) to safely clean up and manage the site's legacy waste; deploy science and technology while incorporating the ISMS theme to ''Do work safely''; andmore » protect human health and the environment.« less

Manned space flight nuclear system safety. Volume 5: Nuclear System safety guidelines. Part 1: Space base nuclear safety

NASA Technical Reports Server (NTRS)

1972-01-01

The design and operations guidelines and requirements developed in the study of space base nuclear system safety are presented. Guidelines and requirements are presented for the space base subsystems, nuclear hardware (reactor, isotope sources, dynamic generator equipment), experiments, interfacing vehicles, ground support systems, range safety and facilities. Cross indices and references are provided which relate guidelines to each other, and to substantiating data in other volumes. The guidelines are intended for the implementation of nuclear safety related design and operational considerations in future space programs.

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

PubMed

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

2006-06-01

Medical errors are common, and physicians have notably been poor medical error reporters. In the SICU, reporting was generally poor and reporting by physicians was virtually nonexistent. This study was designed to observe changes in error reporting in an SICU when a new card-based system (SAFE) was introduced. Before implementation of the SAFE reporting system, education was given to all SICU healthcare providers. The SAFE system was introduced into the SICU for a 9-month period from March 2003 through November 2003, to replace an underused online system. Data were collected from the SAFE card reports and the online reporting systems during introduction, removal, and reimplementation of these cards. Reporting rates were calculated as number of reported events per 1,000 patient days. Reporting rates increased from 19 to 51 reports per 1,000 patient days after the SAFE cards were introduced into the ICU (preporting increased most, rising from 0.3 to 5.8 reports per 1,000 patient days; nursing reporting also increased from 18 to 39 reports per 1,000 patient days (both preporting declined to 0 reports per 1,000 patient days (p=0.01) and rose to 8.1 (p=0.001) when the cards were returned, similar to nursing results. A higher proportion of physician reports were events that caused harm compared with no effect (p < 0.05). A card reporting system, combined with appropriate education, improved overall reporting in the SICU, especially among physician providers. Nurses were more likely to use reporting systems than were physicians. Physician reports were more likely to be of events that caused harm.

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

Cultivating quality: implementing standardized reporting and safety checklists.

PubMed

Stevens, James D; Bader, Mary Kay; Luna, Michele A; Johnson, Linda M

2011-05-01

Developing processes to create a culture of safety. It's estimated that as many as 98,000 hospitalized patients lose their lives each year in the United States because of medical errors that could have been prevented. While standardized reporting and safety checklists have been shown to improve communication and patient safety, implementation of these tools in hospitals remains challenging. To implement standardized nurse-to-nurse reporting along with safety checklists at Mission Hospital, a 522-bed facility in Mission Viejo, California, using Lewin's change theory and Knowles's adult learning theory. Nurses were tested to assess their knowledge of the standardized nurse-to-physician reporting method called SBAR (Situation, Background, Assessment, Recommendation), their understanding of the concept of the nurse-to-nurse reporting method called SBAP (Situation, Background, Assessment, Plan), and the use of safety checklists. Then, after viewing a 22-minute educational video, they were retested. A total of 482 nurses completed the pretest and posttest. On the pretest, the nurses' mean score was 15.935 points (SD, 3.529) out of 20. On the posttest, the mean score was 18.94 (SD, 1.53) out of 20. A Wilcoxon matched-pairs signed-rank test was performed; the two-tailed P value was < 0.001. The application of Lewin's change theory and Knowles's adult learning theory was successful in the process of implementing standardized nurse-to-nurse reporting and safety checklists at Mission Hospital.

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 ...

Why system safety programs can fail

NASA Technical Reports Server (NTRS)

Hammer, W.

1971-01-01

Factors that cause system safety programs to fail are discussed from the viewpoint that in general these programs have not achieved their intended aims. The one item which is considered to contribute most to failure of a system safety program is a poor statement of work which consists of ambiguity, lack of clear definition, use of obsolete requirements, and pure typographical errors. It is pointed out that unless safety requirements are stated clearly, and where they are readily apparent as firm requirements, some of them will be overlooked by designers and contractors. The lack of clarity is stated as being a major contributing factor in system safety program failure and usually evidenced in: (1) lack of clear requirements by the procuring activity, (2) lack of clear understanding of system safety by other managers, and (3) lack of clear methodology to be employed by system safety engineers.

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.

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...

[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.

Fire Safety Tests for Spherical Resorcinol Formaldehyde Resin: Data Summary Report

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

Kim, Dong-Sang; Peterson, Reid A.; Schweiger, Michael J.

2012-07-30

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, which may be overly bounding based on the fire performance data from the manufacturer of the ion exchange resin selected for use at the WTP. To resolve this question, the fire properties of the SRF resin were measuredmore » by Southwest Research Institute (SwRI), following the American Society for Testing and Materials (ASTM) standard procedures, through a subcontract managed by Pacific Northwest National Laboratory (PNNL). For some tests, the ASTM standard procedures were not entirely appropriate or practical for the SRF resin material, so the procedures were modified and deviations from the ASTM standard procedures were noted. This report summarizes the results of fire safety tests performed and reported by SwRI. The efforts by PNNL were limited to summarizing the test results provided by SwRI into one consolidated data report. All as-received SwRI reports are attached to this report in the Appendix. Where applicable, the precision and bias of each test method, as given by each ASTM standard procedure, are included and compared with the SwRI test results of the SRF resin.« less

Does the concept of safety culture help or hinder systems thinking in safety?

PubMed

Reiman, Teemu; Rollenhagen, Carl

2014-07-01

The concept of safety culture has become established in safety management applications in all major safety-critical domains. The idea that safety culture somehow represents a "systemic view" on safety is seldom explicitly spoken out, but nevertheless seem to linger behind many safety culture discourses. However, in this paper we argue that the "new" contribution to safety management from safety culture never really became integrated with classical engineering principles and concepts. This integration would have been necessary for the development of a more genuine systems-oriented view on safety; e.g. a conception of safety in which human, technological, organisational and cultural factors are understood as mutually interacting elements. Without of this integration, researchers and the users of the various tools and methods associated with safety culture have sometimes fostered a belief that "safety culture" in fact represents such a systemic view about safety. This belief is, however, not backed up by theoretical or empirical evidence. It is true that safety culture, at least in some sense, represents a holistic term-a totality of factors that include human, organisational and technological aspects. However, the departure for such safety culture models is still human and organisational factors rather than technology (or safety) itself. The aim of this paper is to critically review the various uses of the concept of safety culture as representing a systemic view on safety. The article will take a look at the concepts of culture and safety culture based on previous studies, and outlines in more detail the theoretical challenges in safety culture as a systems concept. The paper also presents recommendations on how to make safety culture more systemic. Copyright © 2013 Elsevier Ltd. All rights reserved.

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

PubMed

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

2011-05-27

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

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.

10 CFR 72.248 - Safety analysis report updating.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Safety analysis report updating. 72.248 Section 72.248 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF... Approval of Spent Fuel Storage Casks § 72.248 Safety analysis report updating. (a) Each certificate holder...

Integrating system safety into the basic systems engineering process

NASA Technical Reports Server (NTRS)

Griswold, J. W.

1971-01-01

The basic elements of a systems engineering process are given along with a detailed description of what the safety system requires from the systems engineering process. Also discussed is the safety that the system provides to other subfunctions of systems engineering.

49 CFR 385.103 - Safety monitoring system.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false Safety monitoring system. 385.103 Section 385.103... Safety Monitoring System for Mexico-Domiciled Carriers § 385.103 Safety monitoring system. (a) General... Vehicle Safety Standards (FMVSSs), and Hazardous Materials Regulations (HMRs). (b) Roadside monitoring...

49 CFR 385.103 - Safety monitoring system.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 5 2011-10-01 2011-10-01 false Safety monitoring system. 385.103 Section 385.103... Safety Monitoring System for Mexico-Domiciled Carriers § 385.103 Safety monitoring system. (a) General... Vehicle Safety Standards (FMVSSs), and Hazardous Materials Regulations (HMRs). (b) Roadside monitoring...

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...

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.

49 CFR 385.703 - Safety monitoring system.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false Safety monitoring system. 385.703 Section 385.703... Safety Monitoring System for Non-North American Carriers § 385.703 Safety monitoring system. (a) General... Vehicle Safety Standards (FMVSSs), and Hazardous Materials Regulations (HMRs). (b) Roadside monitoring...

49 CFR 385.703 - Safety monitoring system.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 5 2011-10-01 2011-10-01 false Safety monitoring system. 385.703 Section 385.703... Safety Monitoring System for Non-North American Carriers § 385.703 Safety monitoring system. (a) General... Vehicle Safety Standards (FMVSSs), and Hazardous Materials Regulations (HMRs). (b) Roadside monitoring...

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...

14 CFR 91.25 - Aviation Safety Reporting Program: Prohibition against use of reports for enforcement purposes.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Aviation Safety Reporting Program... GENERAL OPERATING AND FLIGHT RULES General § 91.25 Aviation Safety Reporting Program: Prohibition against... to the National Aeronautics and Space Administration under the Aviation Safety Reporting Program (or...

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.

System safety engineering analysis handbook

NASA Technical Reports Server (NTRS)

Ijams, T. E.

1972-01-01

The basic requirements and guidelines for the preparation of System Safety Engineering Analysis are presented. The philosophy of System Safety and the various analytic methods available to the engineering profession are discussed. A text-book description of each of the methods is included.

The President's Report on Occupational Safety and Health.

ERIC Educational Resources Information Center

Department of Health, Education, and Welfare, Washington, DC.

This report describes what has been done to implement the Occupational Safety and Health Act of 1970 during its first year of operation. The report examines the responsibilities of the Department of Labor for setting safety and health standards and also explores the activities of the Department of Health, Education, and Welfare in research and…

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...

The Evolution of System Safety at NASA

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Everett, Chris; Groen, Frank

2014-01-01

The NASA system safety framework is in the process of change, motivated by the desire to promote an objectives-driven approach to system safety that explicitly focuses system safety efforts on system-level safety performance, and serves to unify, in a purposeful manner, safety-related activities that otherwise might be done in a way that results in gaps, redundancies, or unnecessary work. An objectives-driven approach to system safety affords more flexibility to determine, on a system-specific basis, the means by which adequate safety is achieved and verified. Such flexibility and efficiency is becoming increasingly important in the face of evolving engineering modalities and acquisition models, where, for example, NASA will increasingly rely on commercial providers for transportation services to low-earth orbit. A key element of this objectives-driven approach is the use of the risk-informed safety case (RISC): a structured argument, supported by a body of evidence, that provides a compelling, comprehensible and valid case that a system is or will be adequately safe for a given application in a given environment. The RISC addresses each of the objectives defined for the system, providing a rational basis for making informed risk acceptance decisions at relevant decision points in the system life cycle.

Modelling safety of multistate systems with ageing components

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

Kołowrocki, Krzysztof; Soszyńska-Budny, Joanna

An innovative approach to safety analysis of multistate ageing systems is presented. Basic notions of the ageing multistate systems safety analysis are introduced. The system components and the system multistate safety functions are defined. The mean values and variances of the multistate systems lifetimes in the safety state subsets and the mean values of their lifetimes in the particular safety states are defined. The multi-state system risk function and the moment of exceeding by the system the critical safety state are introduced. Applications of the proposed multistate system safety models to the evaluation and prediction of the safty characteristics ofmore » the consecutive “m out of n: F” is presented as well.« less

Potential safety benefits of intelligent cruise control systems.

PubMed

Chira-Chavala, T; Yoo, S M

1994-04-01

Potential safety impact of a hypothetical intelligent cruise control system (ICCS) is evaluated in terms of changes in traffic accidents and some traffic operation characteristics affecting safety. The analysis of changes in traffic accidents is accomplished by in-depth examinations of police accident reports for four major counties in California. The evaluation of changes in traffic operation characteristics affecting safety is accomplished by vehicle simulation. The accident analysis reveals that the use of the hypothetical ICCS could potentially reduce traffic accidents by up to 7.5%. Preliminary vehicle simulation results based on a 10-vehicle convoy indicate that the use of the hypothetical ICCS could reduce frequencies of hard acceleration and deceleration, enhance speed harmonization among vehicles, and reduce incidence of "less-safe" headway.

System safety education focused on industrial engineering

NASA Technical Reports Server (NTRS)

Johnston, W. L.; Morris, R. S.

1971-01-01

An educational program, designed to train students with the specific skills needed to become safety specialists, is described. The discussion concentrates on application, selection, and utilization of various system safety analytical approaches. Emphasis is also placed on the management of a system safety program, its relationship with other disciplines, and new developments and applications of system safety techniques.

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.

Systems Thinking and Patient Safety

DTIC Science & Technology

2005-01-01

1 Prologue Systems Thinking and Patient Safety Paul M. Schyve Patient safety is a prominent theme in health care delivery today. This should... patient safety and a willingness to invest in patient safety research. This volume—published by the Agency for Healthcare Research and Quality (AHRQ...The recent advent of the health care field’s emphasis on patient safety came at a favorable time. One or two decades earlier, our response would have

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.

Preparation for global introduction of inactivated poliovirus vaccine: safety evidence from the US Vaccine Adverse Event Reporting System, 2000-12.

PubMed

Iqbal, Shahed; Shi, Jing; Seib, Katherine; Lewis, Paige; Moro, Pedro L; Woo, Emily J; Shimabukuro, Tom; Orenstein, Walter A

2015-10-01

Safety data from countries with experience in the use of inactivated poliovirus vaccine (IPV) are important for the global polio eradication strategy to introduce IPV into the immunisation schedules of all countries. In the USA, IPV has been included in the routine immunisation schedule since 1997. We aimed to analyse adverse events after IPV administration reported to the US Vaccine Adverse Event Reporting System (VAERS). We analysed all VAERS data associated with IPV submitted between Jan 1, 2000, and Dec 31, 2012, either as individual or as combination vaccines, for all age and sex groups. We analysed the number and event type (non-serious, non-fatal serious, and death reports) of individual reports, and explored the most commonly coded event terms to describe the adverse event. We classified death reports according to previously published body-system categories (respiratory, cardiovascular, neurological, gastrointestinal, other infectious, and other non-infectious) and reviewed death reports to identify the cause of death. We classified sudden infant death syndrome as a separate cause of death considering previous concerns about sudden infant syndrome after vaccines. We used empirical Bayesian data mining methods to identify disproportionate reporting of adverse events for IPV compared with other vaccines. Additional VAERS data from 1991 to 2000 were analysed to compare the safety profiles of IPV and oral poliovirus vaccine (OPV). Of the 41,792 adverse event reports submitted, 39,568 (95%) were for children younger than 7 years. 38,381 of the reports for children in this age group (97%) were for simultaneous vaccination with IPV and other vaccines (most commonly pneumococcal and acellular pertussis vaccines), whereas standalone IPV vaccines accounted for 0·5% of all reports. 34,880 reports were for non-serious events (88%), 3905 reports were for non-fatal serious events (10%), and 783 reports were death reports (2%). Injection-site erythema was the most

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

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...

78 FR 5866 - Pipeline Safety: Annual Reports and Validation

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-28

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket ID PHMSA-2012-0319] Pipeline Safety: Annual Reports and Validation AGENCY: Pipeline and Hazardous Materials... 2012 gas transmission and gathering annual reports, remind pipeline owners and operators to validate...

School Bus Safety Advisory Committee: 1999 Annual Report.

ERIC Educational Resources Information Center

Lazenberry, Dennis; Anderson, Barbara

This report summarizes the deliberations and recommendations of Minnesota's School Bus Safety Advisory Committee (SBSAC). The committee, which operates under the auspices of the Minnesota Department of Public Safety, is charged to study issues affecting the safety of students on school buses, arrive at consensus on ways to improve student safety…

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

Organizational safety culture and medical error reporting by Israeli nurses.

PubMed

Kagan, Ilya; Barnoy, Sivia

2013-09-01

To investigate the association between patient safety culture (PSC) and the incidence and reporting rate of medical errors by Israeli nurses. Self-administered structured questionnaires were distributed to a convenience sample of 247 registered nurses enrolled in training programs at Tel Aviv University (response rate = 91%). The questionnaire's three sections examined the incidence of medication mistakes in clinical practice, the reporting rate for these errors, and the participants' views and perceptions of the safety culture in their workplace at three levels (organizational, departmental, and individual performance). Pearson correlation coefficients, t tests, and multiple regression analysis were used to analyze the data. Most nurses encountered medical errors from a daily to a weekly basis. Six percent of the sample never reported their own errors, while half reported their own errors "rarely or sometimes." The level of PSC was positively and significantly correlated with the error reporting rate. PSC, place of birth, error incidence, and not having an academic nursing degree were significant predictors of error reporting, together explaining 28% of variance. This study confirms the influence of an organizational safety climate on readiness to report errors. Senior healthcare executives and managers can make a major impact on safety culture development by creating and promoting a vision and strategy for quality and safety and fostering their employees' motivation to implement improvement programs at the departmental and individual level. A positive, carefully designed organizational safety culture can encourage error reporting by staff and so improve patient safety. © 2013 Sigma Theta Tau International.

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.

[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.

Product Engineering Class in the Software Safety Risk Taxonomy for Building Safety-Critical Systems

NASA Technical Reports Server (NTRS)

Hill, Janice; Victor, Daniel

2008-01-01

When software safety requirements are imposed on legacy safety-critical systems, retrospective safety cases need to be formulated as part of recertifying the systems for further use and risks must be documented and managed to give confidence for reusing the systems. The SEJ Software Development Risk Taxonomy [4] focuses on general software development issues. It does not, however, cover all the safety risks. The Software Safety Risk Taxonomy [8] was developed which provides a construct for eliciting and categorizing software safety risks in a straightforward manner. In this paper, we present extended work on the taxonomy for safety that incorporates the additional issues inherent in the development and maintenance of safety-critical systems with software. An instrument called a Software Safety Risk Taxonomy Based Questionnaire (TBQ) is generated containing questions addressing each safety attribute in the Software Safety Risk Taxonomy. Software safety risks are surfaced using the new TBQ and then analyzed. In this paper we give the definitions for the specialized Product Engineering Class within the Software Safety Risk Taxonomy. At the end of the paper, we present the tool known as the 'Legacy Systems Risk Database Tool' that is used to collect and analyze the data required to show traceability to a particular safety standard

Inadequate safety reporting in pre-eclampsia trials: a systematic evaluation.

PubMed

Duffy, Jmn; Hirsch, M; Pealing, L; Showell, M; Khan, K S; Ziebland, S; McManus, R J

2018-06-01

Randomised trials and their syntheses in meta-analyses offer a unique opportunity to assess the frequency and severity of adverse reactions. To assess safety reporting in pre-eclampsia trials. Systematic search using bibliographic databases, including Cochrane Central Register of Controlled Trials, Embase, and MEDLINE, from inception to August 2017. Randomised trials evaluating anticonvulsant or antihypertensive medication for pre-eclampsia. Descriptive statistics appraising the adequacy of adverse reaction and toxicity reporting. We included 60 randomised trials. Six trials (10%) were registered with the International Clinical Trials Registry Platform, two registry records referred to adverse reactions, stating 'safety and toleration' and 'possible side effects' would be collected. Twenty-six trials (43%) stated the frequency of withdrawals within each study arm, and five trials (8%) adequately reported these withdrawals. Adverse reactions were inconsistently reported across eligible trials: 24 (40%) reported no serious adverse reactions and 36 (60%) reported no mild adverse reactions. The methods of definition or measurement of adverse reactions were infrequently reported within published trial reports. Pre-eclampsia trials regularly omit critical information related to safety. Despite the paucity of reporting, randomised trials collect an enormous amount of safety data. Developing and implementing a minimum data set could help to improve safety reporting, permitting a more balanced assessment of interventions by considering the trade-off between the benefits and harms. National Institute for Health Research (DRF-2014-07-051), UK; Maternity Forum, Royal Society of Medicine, UK. Developing @coreoutcomes could help to improve safety reporting in #preeclampsia trials. @NIHR_DC. © 2017 Royal College of Obstetricians and Gynaecologists.

In-space propellant systems safety. Volume 3: System safety analysis

NASA Technical Reports Server (NTRS)

1972-01-01

The primary objective was to examine from a system safety viewpoint in-space propellant logistic elements and operations to define the potential hazards and to recommend means to reduce, eliminate or control them. A secondary objective was to conduct trade studies of specific systems or operations to determine the safest of alternate approaches.

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;...

NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

1978-01-01

A sample of reports relating to operations during winter weather is presented. Several reports involving problems of judgment and decisionmaking have been selected from the numerous reports representative of this area. Problems related to aeronautical charts are discussed in a number of reports. An analytic study of reports involving potential conflicts in the immediate vicinity of uncontrolled airports was performed; the results are discussed in this report. It was found that in three-fourths of 127 such conflicts, neither pilot, or only one of the pilots, was communicating position and intentions on the appropriate frequency. The importance of providing aural transfer of information, as a backup to the visual see and avoid mode of information transfer is discussed. It was also found that a large fraction of pilots involved in potential conflicts on final approach had executed straight-in approaches, rather than the recommended traffic pattern entries, prior to the conflicts. A selection of alert bulletins and responses to them by various segments of the aviation community is presented.

Software system safety

NASA Technical Reports Server (NTRS)

Uber, James G.

1988-01-01

Software itself is not hazardous, but since software and hardware share common interfaces there is an opportunity for software to create hazards. Further, these software systems are complex, and proven methods for the design, analysis, and measurement of software safety are not yet available. Some past software failures, future NASA software trends, software engineering methods, and tools and techniques for various software safety analyses are reviewed. Recommendations to NASA are made based on this review.

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.

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.

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.

A Taxonomy of Fallacies in System Safety Arguments

NASA Technical Reports Server (NTRS)

Greenwell, William S.; Knight, John C.; Holloway, C. Michael; Pease, Jacob J.

2006-01-01

Safety cases are gaining acceptance as assurance vehicles for safety-related systems. A safety case documents the evidence and argument that a system is safe to operate; however, logical fallacies in the underlying argument may undermine a system s safety claims. Removing these fallacies is essential to reduce the risk of safety-related system failure. We present a taxonomy of common fallacies in safety arguments that is intended to assist safety professionals in avoiding and detecting fallacious reasoning in the arguments they develop and review. The taxonomy derives from a survey of general argument fallacies and a separate survey of fallacies in real-world safety arguments. Our taxonomy is specific to safety argumentation, and it is targeted at professionals who work with safety arguments but may lack formal training in logic or argumentation. We discuss the rationale for the selection and categorization of fallacies in the taxonomy. In addition to its applications to the development and review of safety cases, our taxonomy could also support the analysis of system failures and promote the development of more robust safety case patterns.

System safety management: A new discipline

NASA Technical Reports Server (NTRS)

Pope, W. C.

1971-01-01

The systems theory is discussed in relation to safety management. It is suggested that systems safety management, as a new discipline, holds great promise for reducing operating errors, conserving labor resources, avoiding operating costs due to mistakes, and for improving managerial techniques. It is pointed out that managerial failures or system breakdowns are the basic reasons for human errors and condition defects. In this respect, a recommendation is made that safety engineers stop visualizing the problem only with the individual (supervisor or employee) and see the problem from the systems point of view.

Aerospace Safety Advisory Panel Annual Report February 1996

NASA Technical Reports Server (NTRS)

1996-01-01

The Aerospace Safety Advisory Panel (ASAP) presents its annual report covering February through December 1995. Findings and recommendations include the areas of the Space Shuttle Program, the International Space Station, Aeronautics, and Other. Information to support these findings is included in this report. NASA's response to last year's annual report is included as an appendix. With regards to the Space Shuttle Program, the panel addresses the potential for safety problems due to organizational changes by increasing its scrutiny of Space Shuttle operations and planning.

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.

Safety and Sex Practices among Nebraska Adolescents. Technical Report 24.

ERIC Educational Resources Information Center

Newman, Ian M.; Perry-Hunnicutt, Christina

This report describes a range of adolescent behaviors related to their safety and the safety of others. The behaviors reported here range from ordinary safety precautions such as only swimming in supervised areas and wearing helmets when riding a motorcycle to less talked about behaviors such as using condoms during sexual intercourse and carrying…

Transportation Safety Information Report : 1988 annual summary

DOT National Transportation Integrated Search

1989-12-01

The Report is a compendium of selected national-level transportation safety statistics for all modes of transportation and for multimodal transportation of hazardous materials. The report presents and compares data for transportation fatalities, acci...

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.

Patient Safety and the Malpractice System.

PubMed

Swift, James Q

2017-05-01

The cost of health care in the United States and malpractice insurance has escalated greatly over the past 30 years. In an ideal world, the goals of the tort system would be aligned with efforts at improving safety. In fact, there is little evidence that the tort system and the processes of risk management and informed consent have improved patient safety. This article explores the disunion between patient safety and the malpractice system. Copyright © 2016 Elsevier Inc. All rights reserved.

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

Nuclear electric propulsion operational reliability and crew safety study: NEP systems/modeling report

NASA Technical Reports Server (NTRS)

Karns, James

1993-01-01

The objective of this study was to establish the initial quantitative reliability bounds for nuclear electric propulsion systems in a manned Mars mission required to ensure crew safety and mission success. Finding the reliability bounds involves balancing top-down (mission driven) requirements and bottom-up (technology driven) capabilities. In seeking this balance we hope to accomplish the following: (1) provide design insights into the achievability of the baseline design in terms of reliability requirements, given the existing technology base; (2) suggest alternative design approaches which might enhance reliability and crew safety; and (3) indicate what technology areas require significant research and development to achieve the reliability objectives.

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.

Safer Systems: A NextGen Aviation Safety Strategic Goal

NASA Technical Reports Server (NTRS)

Darr, Stephen T.; Ricks, Wendell R.; Lemos, Katherine A.

2008-01-01

The Joint Planning and Development Office (JPDO), is charged by Congress with developing the concepts and plans for the Next Generation Air Transportation System (NextGen). The National Aviation Safety Strategic Plan (NASSP), developed by the Safety Working Group of the JPDO, focuses on establishing the goals, objectives, and strategies needed to realize the safety objectives of the NextGen Integrated Plan. The three goal areas of the NASSP are Safer Practices, Safer Systems, and Safer Worldwide. Safer Practices emphasizes an integrated, systematic approach to safety risk management through implementation of formalized Safety Management Systems (SMS) that incorporate safety data analysis processes, and the enhancement of methods for ensuring safety is an inherent characteristic of NextGen. Safer Systems emphasizes implementation of safety-enhancing technologies, which will improve safety for human-centered interfaces and enhance the safety of airborne and ground-based systems. Safer Worldwide encourages coordinating the adoption of the safer practices and safer systems technologies, policies and procedures worldwide, such that the maximum level of safety is achieved across air transportation system boundaries. This paper introduces the NASSP and its development, and focuses on the Safer Systems elements of the NASSP, which incorporates three objectives for NextGen systems: 1) provide risk reducing system interfaces, 2) provide safety enhancements for airborne systems, and 3) provide safety enhancements for ground-based systems. The goal of this paper is to expose avionics and air traffic management system developers to NASSP objectives and Safer Systems strategies.

Psychological safety and error reporting within Veterans Health Administration hospitals.

PubMed

Derickson, Ryan; Fishman, Jonathan; Osatuke, Katerine; Teclaw, Robert; Ramsel, Dee

2015-03-01

In psychologically safe workplaces, employees feel comfortable taking interpersonal risks, such as pointing out errors. Previous research suggested that psychologically safe climate optimizes organizational outcomes. We evaluated psychological safety levels in Veterans Health Administration (VHA) hospitals and assessed their relationship to employee willingness of reporting medical errors. We conducted an ANOVA on psychological safety scores from a VHA employees census survey (n = 185,879), assessing variability of means across racial and supervisory levels. We examined organizational climate assessment interviews (n = 374) evaluating how many employees asserted willingness to report errors (or not) and their stated reasons. Finally, based on survey data, we identified 2 (psychologically safe versus unsafe) hospitals and compared their number of employees who would be willing/unwilling to report an error. Psychological safety increased with supervisory level (P < 0.001, η = 0.03) and was not meaningfully related to race (P < 0.001, η = 0.003). Twelve percent of employees would not report an error; retaliation fear was the most commonly mentioned deterrent. Furthermore, employees at the psychologically unsafe hospital (71% would report, 13% would not) were less willing to report an error than at the psychologically safe hospital (91% would, 0% would not). A substantial minority would not report an error and were willing to admit so in a private interview setting. Their stated reasons as well as higher psychological safety means for supervisory employees both suggest power as an important determinant. Intentions to report were associated with psychological safety, strongly suggesting this climate aspect as instrumental to improving patient safety and reducing costs.

Transportation systems safety hazard analysis tool (SafetyHAT) user guide (version 1.0)

DOT National Transportation Integrated Search

2014-03-24

This is a user guide for the transportation system Safety Hazard Analysis Tool (SafetyHAT) Version 1.0. SafetyHAT is a software tool that facilitates System Theoretic Process Analysis (STPA.) This user guide provides instructions on how to download, ...

Safety features of subcritical fluid fueled systems

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

Bell, C.R.

1995-10-01

Accelerator-driven transmutation technology has been under study at Los Alamos for several years for application to nuclear waste treatment, tritium production, energy generation, and recently, to the disposition of excess weapons plutonium. Studies and evaluations performed to date at Los Alamos have led to a current focus on a fluid-fuel, fission system operating in a neutron source-supported subcritical mode, using molten salt reactor technology and accelerator-driven proton-neutron spallation. In this paper, the safety features and characteristics of such systems are explored from the perspective of the fundamental nuclear safety objectives that any reactor-type system should address. This exploration is qualitativemore » in nature and uses current vintage solid-fueled reactors as a baseline for comparison. Based on the safety perspectives presented, such systems should be capable of meeting the fundamental nuclear safety objectives. In addition, they should be able to provide the safety robustness desired for advanced reactors. However, the manner in which safety objectives and robustness are achieved is very different from that associated with conventional reactors. Also, there are a number of safety design and operational challenges that will have to be addressed for the safety potential of such systems to be credible.« less

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

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

46 CFR 62.25-15 - Safety control systems.

Code of Federal Regulations, 2011 CFR

2011-10-01

....35-50. Note: Safety control systems include automatic and manual safety trip controls and automatic... engines. (e) Automatic safety trip control systems must— (1) Be provided where there is an immediate... 46 Shipping 2 2011-10-01 2011-10-01 false Safety control systems. 62.25-15 Section 62.25-15...

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

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.

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 ...

The Safety of School Children in Arkansas. Special Report.

ERIC Educational Resources Information Center

Kelly, Paul D.

Noting that parents are very concerned about the safety of their children and the impact school violence has on their children's academic success, this report is intended to help parents and others understand how school safety is monitored in Arkansas. The report presents information on what students say about their access to weapons and…

Onboard Monitoring and Reporting for Commercial Motor Vehicle Safety Final Report

DOT National Transportation Integrated Search

2008-02-01

This Final Report describes the process and product from the project, Onboard Monitoring and Reporting for Commercial Motor Vehicle Safety (OBMS), in which a prototypical suite of hardware and software on a class 8 truck was developed and tested. The...

Transit safety retrofit package development : final report.

DOT National Transportation Integrated Search

2014-07-01

This report provides a summary of the Transit Safety Retrofit Package (TRP) Development project and its results. The report documents results of each project phase, and provides recommended next steps as well as a vision for a next generation TRP. Th...

System theory and safety models in Swedish, UK, Dutch and Australian road safety strategies.

PubMed

Hughes, B P; Anund, A; Falkmer, T

2015-01-01

Road safety strategies represent interventions on a complex social technical system level. An understanding of a theoretical basis and description is required for strategies to be structured and developed. Road safety strategies are described as systems, but have not been related to the theory, principles and basis by which systems have been developed and analysed. Recently, road safety strategies, which have been employed for many years in different countries, have moved to a 'vision zero', or 'safe system' style. The aim of this study was to analyse the successful Swedish, United Kingdom and Dutch road safety strategies against the older, and newer, Australian road safety strategies, with respect to their foundations in system theory and safety models. Analysis of the strategies against these foundations could indicate potential improvements. The content of four modern cases of road safety strategy was compared against each other, reviewed against scientific systems theory and reviewed against types of safety model. The strategies contained substantial similarities, but were different in terms of fundamental constructs and principles, with limited theoretical basis. The results indicate that the modern strategies do not include essential aspects of systems theory that describe relationships and interdependencies between key components. The description of these strategies as systems is therefore not well founded and deserves further development. Copyright © 2014 Elsevier Ltd. All rights reserved.

Design an optimum safety policy for personnel safety management - A system dynamic approach

NASA Astrophysics Data System (ADS)

Balaji, P.

2014-10-01

Personnel safety management (PSM) ensures that employee's work conditions are healthy and safe by various proactive and reactive approaches. Nowadays it is a complex phenomenon because of increasing dynamic nature of organisations which results in an increase of accidents. An important part of accident prevention is to understand the existing system properly and make safety strategies for that system. System dynamics modelling appears to be an appropriate methodology to explore and make strategy for PSM. Many system dynamics models of industrial systems have been built entirely for specific host firms. This thesis illustrates an alternative approach. The generic system dynamics model of Personnel safety management was developed and tested in a host firm. The model was undergone various structural, behavioural and policy tests. The utility and effectiveness of model was further explored through modelling a safety scenario. In order to create effective safety policy under resource constraint, DOE (Design of experiment) was used. DOE uses classic designs, namely, fractional factorials and central composite designs. It used to make second order regression equation which serve as an objective function. That function was optimized under budget constraint and optimum value used for safety policy which shown greatest improvement in overall PSM. The outcome of this research indicates that personnel safety management model has the capability for acting as instruction tool to improve understanding of safety management and also as an aid to policy making.

Design an optimum safety policy for personnel safety management - A system dynamic approach

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

Balaji, P.

2014-10-06

Personnel safety management (PSM) ensures that employee's work conditions are healthy and safe by various proactive and reactive approaches. Nowadays it is a complex phenomenon because of increasing dynamic nature of organisations which results in an increase of accidents. An important part of accident prevention is to understand the existing system properly and make safety strategies for that system. System dynamics modelling appears to be an appropriate methodology to explore and make strategy for PSM. Many system dynamics models of industrial systems have been built entirely for specific host firms. This thesis illustrates an alternative approach. The generic system dynamicsmore » model of Personnel safety management was developed and tested in a host firm. The model was undergone various structural, behavioural and policy tests. The utility and effectiveness of model was further explored through modelling a safety scenario. In order to create effective safety policy under resource constraint, DOE (Design of experiment) was used. DOE uses classic designs, namely, fractional factorials and central composite designs. It used to make second order regression equation which serve as an objective function. That function was optimized under budget constraint and optimum value used for safety policy which shown greatest improvement in overall PSM. The outcome of this research indicates that personnel safety management model has the capability for acting as instruction tool to improve understanding of safety management and also as an aid to policy making.« less

Autonomous Flight Safety System

NASA Technical Reports Server (NTRS)

Simpson, James

2010-01-01

The Autonomous Flight Safety System (AFSS) is an independent self-contained subsystem mounted onboard a launch vehicle. AFSS has been developed by and is owned by the US Government. Autonomously makes flight termination/destruct decisions using configurable software-based rules implemented on redundant flight processors using data from redundant GPS/IMU navigation sensors. AFSS implements rules determined by the appropriate Range Safety officials.

Quality and Safety Implications of Emergency Department Information Systems

PubMed Central

Farley, Heather L.; Baumlin, Kevin M.; Hamedani, Azita G.; Cheung, Dickson S.; Edwards, Michael R.; Fuller, Drew C.; Genes, Nicholas; Griffey, Richard T.; Kelly, John J.; McClay, James C.; Nielson, Jeff; Phelan, Michael P.; Shapiro, Jason S.; Stone-Griffith, Suzanne; Pines, Jesse M.

2013-01-01

The Health Information Technology for Economic and Clinical Health Act of 2009 and the Centers for Medicare & Medicaid Services “meaningful use” incentive programs, in tandem with the boundless additional requirements for detailed reporting of quality metrics, have galvanized hospital efforts to implement hospital-based electronic health records. As such, emergency department information systems (EDISs) are an important and unique component of most hospitals’ electronic health records. System functionality varies greatly and affects physician decisionmaking, clinician workflow, communication, and, ultimately, the overall quality of care and patient safety. This article is a joint effort by members of the Quality Improvement and Patient Safety Section and the Informatics Section of the American College of Emergency Physicians. The aim of this effort is to examine the benefits and potential threats to quality and patient safety that could result from the choice of a particular EDIS, its implementation and optimization, and the hospital’s or physician group’s approach to continuous improvement of the EDIS. Specifically, we explored the following areas of potential EDIS safety concerns: communication failure, wrong order–wrong patient errors, poor data display, and alert fatigue. Case studies are presented that illustrate the potential harm that could befall patients from an inferior EDIS product or suboptimal execution of such a product in the clinical environment. The authors have developed 7 recommendations to improve patient safety with respect to the deployment of EDISs. These include ensuring that emergency providers actively participate in selection of the EDIS product, in the design of processes related to EDIS implementation and optimization, and in the monitoring of the system’s ongoing success or failure. Our recommendations apply to emergency departments using any type of EDIS: custom-developed systems, best-of-breed vendor systems, or

Nuclear Reactor Safety--The APS Submits its Report

ERIC Educational Resources Information Center

Physics Today, 1975

1975-01-01

Presents the summary section of the American Physical Society (APS) report on the safety features of the light-water reactor, reviews the design, construction, and operation of a reactor and outlines the primary engineered safety features. Summarizes the major recommendations of the study group. (GS)

System Safety in Aircraft Acquisition

DTIC Science & Technology

1984-01-01

Relationship Between JSSC and SOHP ..... .......... 6- 1 Some Similarities in the Departments’ Approaches to System Safety... RELATIONSHIP BETWEEN JSSC AND SOHP The annual JSSC sponsored by the safety centers coordinates safety activities. It was described recently as "an unchartered...developed an excellent working relationship . Re- presentatives from SOHP can and do influence tasks undertaken by JSSC. Con- versely, SOUP is the one

Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance.

PubMed

Banerjee, Anjan K; Okun, Sally; Edwards, I Ralph; Wicks, Paul; Smith, Meredith Y; Mayall, Stephen J; Flamion, Bruno; Cleeland, Charles; Basch, Ethan

2013-12-01

The Patient-Reported Outcomes Safety Event Reporting (PROSPER) Consortium was convened to improve safety reporting by better incorporating the perspective of the patient. PROSPER comprises industry, regulatory authority, academic, private sector and patient representatives who are interested in the area of patient-reported outcomes of adverse events (PRO-AEs). It has developed guidance on PRO-AE data, including the benefits of wider use and approaches for data capture and analysis. Patient-reported outcomes (PROs) encompass the full range of self-reporting, rather than only patient reports collected by clinicians using validated instruments. In recent years, PROs have become increasingly important across the spectrum of healthcare and life sciences. Patient-centred models of care are integrating shared decision making and PROs at the point of care; comparative effectiveness research seeks to include patients as participatory stakeholders; and industry is expanding its involvement with patients and patient groups as part of the drug development process and safety monitoring. Additionally, recent pharmacovigilance legislation from regulatory authorities in the EU and the USA calls for the inclusion of patient-reported information in benefit-risk assessment of pharmaceutical products. For patients, technological advancements have made it easier to be an active participant in one's healthcare. Simplified internet search capabilities, electronic and personal health records, digital mobile devices, and PRO-enabled patient online communities are just a few examples of tools that allow patients to gain increased knowledge about conditions, symptoms, treatment options and side effects. Despite these changes and increased attention on the perceived value of PROs, their full potential has yet to be realised in pharmacovigilance. Current safety reporting and risk assessment processes remain heavily dependent on healthcare professionals, though there are known limitations such

System safety education focused on system management

NASA Technical Reports Server (NTRS)

Grose, V. L.

1971-01-01

System safety is defined and characteristics of the system are outlined. Some of the principle characteristics include role of humans in hazard analysis, clear language for input and output, system interdependence, self containment, and parallel analysis of elements.

76 FR 14592 - Safety Management System; Withdrawal

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-17

...-06A] RIN 2120-AJ15 Safety Management System; Withdrawal AGENCY: Federal Aviation Administration (FAA... (``product/ service providers'') to develop a Safety Management System (SMS). The FAA is withdrawing the... management with a set of robust decision-making tools to use to improve safety. The FAA received 89 comments...

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...

Database management systems for process safety.

PubMed

Early, William F

2006-03-17

Several elements of the process safety management regulation (PSM) require tracking and documentation of actions; process hazard analyses, management of change, process safety information, operating procedures, training, contractor safety programs, pre-startup safety reviews, incident investigations, emergency planning, and compliance audits. These elements can result in hundreds of actions annually that require actions. This tracking and documentation commonly is a failing identified in compliance audits, and is difficult to manage through action lists, spreadsheets, or other tools that are comfortably manipulated by plant personnel. This paper discusses the recent implementation of a database management system at a chemical plant and chronicles the improvements accomplished through the introduction of a customized system. The system as implemented modeled the normal plant workflows, and provided simple, recognizable user interfaces for ease of use.

The Impact of a Patient Safety Program on Medical Error Reporting

DTIC Science & Technology

2005-05-01

307 The Impact of a Patient Safety Program on Medical Error Reporting Donald R. Woolever Abstract Background: In response to the occurrence of...a sentinel event—a medical error with serious consequences—Eglin U.S. Air Force (USAF) Regional Hospital developed and implemented a patient safety...communication, teamwork, and reporting. Objective: To determine the impact of a patient safety program on patterns of medical error reporting. Methods: This

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...

From the school of nursing quality and safety officer: nursing students' use of safety reporting tools and their perception of safety issues in clinical settings.

PubMed

Cooper, Elizabeth

2013-01-01

Improved patient safety and quality are priority goals for nurses and schools of nursing. This article describes the innovative new role of quality and safety officer (QSO) developed by one university in response to the Quality and Safety Education for Nurses challenge to increase quality and safety education for prelicensure nursing students. The article also describes the results of a study conducted by the QSO, obtaining information from prelicensure nursing students about the use of safety tools and identifying the students' perceptions of safety issues, communication, and safety reporting in the clinical setting. Responses of 145 prelicensure nursing students suggest that it is difficult to get all errors and near-miss events reported. Barriers for nursing students are similar to the barriers nurses and physicians identify in reporting errors and near-miss events. The survey reveals that safety for the patient is the primary concern of the student nurse. Copyright © 2013 Elsevier Inc. All rights reserved.

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...

Nuclear Safety for Space Systems

NASA Astrophysics Data System (ADS)

Offiong, Etim

2010-09-01

It is trite, albeit a truism, to say that nuclear power can provide propulsion thrust needed to launch space vehicles and also, to provide electricity for powering on-board systems, especially for missions to the Moon, Mars and other deep space missions. Nuclear Power Sources(NPSs) are known to provide more capabilities than solar power, fuel cells and conventional chemical means. The worry has always been that of safety. The earliest superpowers(US and former Soviet Union) have designed and launched several nuclear-powered systems, with some failures. Nuclear failures and accidents, however little the number, could be far-reaching geographically, and are catastrophic to humans and the environment. Building on the numerous research works on nuclear power on Earth and in space, this paper seeks to bring to bear, issues relating to safety of space systems - spacecrafts, astronauts, Earth environment and extra terrestrial habitats - in the use and application of nuclear power sources. It also introduces a new formal training course in Space Systems Safety.

Physics of reactor safety. Quarterly report, January--March 1977. [LMFBR

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

None

1977-06-01

This report summarizes work done on reactor safety, Monte Carlo analysis of safety-related critical assembly experiments, and planning of DEMI safety-related critical experiments. Work on reactor core thermal-hydraulics is also included.

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

PubMed

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

2009-01-01

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

49 CFR 659.19 - System safety program plan: contents.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 7 2012-10-01 2012-10-01 false System safety program plan: contents. 659.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.19 System safety program plan: contents. The system safety plan shall...

49 CFR 659.19 - System safety program plan: contents.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 7 2011-10-01 2011-10-01 false System safety program plan: contents. 659.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.19 System safety program plan: contents. The system safety plan shall...

49 CFR 659.19 - System safety program plan: contents.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 7 2013-10-01 2013-10-01 false System safety program plan: contents. 659.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.19 System safety program plan: contents. The system safety plan shall...

49 CFR 659.19 - System safety program plan: contents.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 7 2014-10-01 2014-10-01 false System safety program plan: contents. 659.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.19 System safety program plan: contents. The system safety plan shall...

49 CFR 659.19 - System safety program plan: contents.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 7 2010-10-01 2010-10-01 false System safety program plan: contents. 659.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.19 System safety program plan: contents. The system safety plan shall...

Safety climate and culture: Integrating psychological and systems perspectives.

PubMed

Casey, Tristan; Griffin, Mark A; Flatau Harrison, Huw; Neal, Andrew

2017-07-01

Safety climate research has reached a mature stage of development, with a number of meta-analyses demonstrating the link between safety climate and safety outcomes. More recently, there has been interest from systems theorists in integrating the concept of safety culture and to a lesser extent, safety climate into systems-based models of organizational safety. Such models represent a theoretical and practical development of the safety climate concept by positioning climate as part of a dynamic work system in which perceptions of safety act to constrain and shape employee behavior. We propose safety climate and safety culture constitute part of the enabling capitals through which organizations build safety capability. We discuss how organizations can deploy different configurations of enabling capital to exert control over work systems and maintain safe and productive performance. We outline 4 key strategies through which organizations to reconcile the system control problems of promotion versus prevention, and stability versus flexibility. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

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 : ...

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.

Health and safety management systems: liability or asset?

PubMed

Bennett, David

2002-01-01

Health and safety management systems have a background in theory and in various interests among employers and workplace health and safety professionals. These have resulted in a number of national systems emanating from national standard-writing centres and from employers' organizations. In some cases these systems have been recognized as national standards. The contenders for an international standard have been the International Organization of Standardization (ISO) and the International Labour Organization (ILO). The quality and environmental management systems of ISO indicate what an ISO health and safety management standard would look like. The ILO Guidelines on Safety and Health Management Systems, by contrast, are stringent, specific and potentially effective in improving health and safety performance in the workplace.

Autonomous Flight Safety System Road Test

NASA Technical Reports Server (NTRS)

Simpson, James C.; Zoemer, Roger D.; Forney, Chris S.

2005-01-01

On February 3, 2005, Kennedy Space Center (KSC) conducted the first Autonomous Flight Safety System (AFSS) test on a moving vehicle -- a van driven around the KSC industrial area. A subset of the Phase III design was used consisting of a single computer, GPS receiver, and UPS antenna. The description and results of this road test are described in this report.AFSS is a joint KSC and Wallops Flight Facility project that is in its third phase of development. AFSS is an independent subsystem intended for use with Expendable Launch Vehicles that uses tracking data from redundant onboard sensors to autonomously make flight termination decisions using software-based rules implemented on redundant flight processors. The goals of this project are to increase capabilities by allowing launches from locations that do not have or cannot afford extensive ground-based range safety assets, to decrease range costs, and to decrease reaction time for special situations.

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

NASA Astrophysics Data System (ADS)

Guo, Jingjing

Quantitative Safety Assessments (QSA) are essential to safety benefit verification and regulations of developmental changes in safety critical systems like the Air Traffic Control (ATC) systems. Effectiveness of the assessments is particularly desirable today in the safe implementations of revolutionary ATC overhauls like NextGen and SESAR. QSA of ATC systems are however challenged by system complexity and lack of accident data. Extending from the idea "safety is a control problem" in the literature, this research proposes to assess system safety from the control perspective, through quantifying a system's "control capacity". A system's safety performance correlates to this "control capacity" in the control of "safety critical processes". To examine this idea in QSA of the ATC systems, a Control-capacity Based Safety Assessment Framework (CBSAF) is developed which includes two control capacity metrics and a procedural method. The two metrics are Probabilistic System Control-capacity (PSC) and Temporal System Control-capacity (TSC); each addresses an aspect of a system's control capacity. And the procedural method consists three general stages: I) identification of safety critical processes, II) development of system control models and III) evaluation of system control capacity. The CBSAF was tested in two case studies. The first one assesses an en-route collision avoidance scenario and compares three hypothetical configurations. The CBSAF was able to capture the uncoordinated behavior between two means of control, as was observed in a historic midair collision accident. The second case study compares CBSAF with an existing risk based QSA method in assessing the safety benefits of introducing a runway incursion alert system. Similar conclusions are reached between the two methods, while the CBSAF has the advantage of simplicity and provides a new control-based perspective and interpretation to the assessments. The case studies are intended to investigate the

System Study: High-Pressure Safety Injection 1998-2014

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

Schroeder, John Alton

2015-12-01

This report presents an unreliability evaluation of the high-pressure safety injection system (HPSI) at 69 U.S. commercial nuclear power plants. Demand, run hours, and failure data from fiscal year 1998 through 2014 for selected components were obtained from the Institute of Nuclear Power Operations (INPO) Consolidated Events Database (ICES). The unreliability results are trended for the most recent 10 year period, while yearly estimates for system unreliability are provided for the entire active period. No statistically significant increasing or decreasing trends were identified in the HPSI results.

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

49 CFR 659.15 - System safety program standard.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 7 2010-10-01 2010-10-01 false System safety program standard. 659.15 Section 659... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.15 System safety program standard. (a) General requirement. Each state...

New Entrant Safety Research. Final Report.

DOT National Transportation Integrated Search

1998-04-23

This report documents a study of the safety performance and compliance of motor carriers entering interstate service, i.e., new entrants, and the possible need for a new entrant prequalification and monitoring program. The study was conducted by the ...

76 FR 5494 - Pipeline Safety: Mechanical Fitting Failure Reporting Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-01

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part... Safety: Mechanical Fitting Failure Reporting Requirements AGENCY: Pipeline and Hazardous Materials Safety... tightening. A widely accepted industry guidance document, Gas Pipeline Technical Committee (GPTC) Guide, does...

49 CFR 659.15 - System safety program standard.

Code of Federal Regulations, 2011 CFR

2011-10-01

... included in the affected rail transit agency's system safety program plan relating to the hazard management... 49 Transportation 7 2011-10-01 2011-10-01 false System safety program standard. 659.15 Section 659... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the...

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.

46 CFR 62.25-15 - Safety control systems.

Code of Federal Regulations, 2012 CFR

2012-10-01

... manual safety trip controls must be provided for all main boilers, turbines, and internal combustion... 46 Shipping 2 2012-10-01 2012-10-01 false Safety control systems. 62.25-15 Section 62.25-15... AUTOMATION General Requirements for All Automated Vital Systems § 62.25-15 Safety control systems. (a...

46 CFR 62.25-15 - Safety control systems.

Code of Federal Regulations, 2013 CFR

2013-10-01

... manual safety trip controls must be provided for all main boilers, turbines, and internal combustion... 46 Shipping 2 2013-10-01 2013-10-01 false Safety control systems. 62.25-15 Section 62.25-15... AUTOMATION General Requirements for All Automated Vital Systems § 62.25-15 Safety control systems. (a...

46 CFR 62.25-15 - Safety control systems.

Code of Federal Regulations, 2014 CFR

2014-10-01

... manual safety trip controls must be provided for all main boilers, turbines, and internal combustion... 46 Shipping 2 2014-10-01 2014-10-01 false Safety control systems. 62.25-15 Section 62.25-15... AUTOMATION General Requirements for All Automated Vital Systems § 62.25-15 Safety control systems. (a...

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...

[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.

Special report. Revising your fire safety plans.

PubMed

1993-12-01

Every hospital has a fire safety plan, although some fail to update their plans when circumstances change, such as when the facility is refurbished or new fire protection equipment is added, or when new wings bring in additional patients and staff. Others may fail to develop new education programs to heighten staff awareness of what is expected of them during a fire and to train employees to meet those expectations. In this report, we'll examine the new fire safety plans at two Massachusetts hospitals and the revisions they made to address these issues. We'll offer suggestions for effectively evaluating and revising your own fire safety plans.

Systems pharmacology augments drug safety surveillance

PubMed Central

Lorberbaum, Tal; Nasir, Mavra; Keiser, Michael J.; Vilar, Santiago; Hripcsak, George; Tatonetti, Nicholas P.

2014-01-01

Small molecule drugs are the foundation of modern medical practice yet their use is limited by the onset of unexpected and severe adverse events (AEs). Regulatory agencies rely on post-marketing surveillance to monitor safety once drugs are approved for clinical use. Despite advances in pharmacovigilance methods that address issues of confounding bias, clinical data of AEs are inherently noisy. Systems pharmacology– the integration of systems biology and chemical genomics – can illuminate drug mechanisms of action. We hypothesize that these data can improve drug safety surveillance by highlighting drugs with a mechanistic connection to the target phenotype (enriching true positives) and filtering those that do not (depleting false positives). We present an algorithm, the modular assembly of drug safety subnetworks (MADSS), to combine systems pharmacology and pharmacovigilance data and significantly improve drug safety monitoring for four clinically relevant adverse drug reactions. PMID:25670520

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.

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.

Factors related to increasing safety belt use in states with safety belt use laws : second annual report to Congress

DOT National Transportation Integrated Search

1989-01-01

This report is the second in a series of four annual reports to the Congress on provisions of state safety belt use laws and other programmatic factors related to increasing safety belt use levels. The first Congressional Report reviewed what was kno...

Safety analysis report for the Waste Storage Facility. Revision 2

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

Bengston, S.J.

1994-05-01

This safety analysis report outlines the safety concerns associated with the Waste Storage Facility located in the Radioactive Waste Management Complex at the Idaho National Engineering Laboratory. The three main objectives of the report are: define and document a safety basis for the Waste Storage Facility activities; demonstrate how the activities will be carried out to adequately protect the workers, public, and environment; and provide a basis for review and acceptance of the identified risk that the managers, operators, and owners will assume.

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...

Trinity cable safety system.

DOT National Transportation Integrated Search

2007-01-31

Cab1eSafety System (CASS).is being tested by the Oklahoma Department of Transportation (ODOT) along I-35 in McClain County. CASS will be compare with two other system approve by ODOT. Using C-shaped post tensioned cables, CASS is designed to...

Sociology, systems and (patient) safety: knowledge translations in healthcare policy.

PubMed

Jensen, Casper Bruun

2008-03-01

In 2000 the American Institute of Medicine, adviser to the federal government on policy matters relating to the health of the public, published the report To Err is Human: Building a Safer Health System, which was to become a call to arms for improving patient safety across the Western world. By re-conceiving healthcare as a system, it was argued that it was possible to transform the current culture of blame, which made individuals take defensive precautions against being assigned responsibility for error - notably by not reporting adverse events, into a culture of safety. The IOM report draws on several prominent social scientists in accomplishing this re-conceptualisation. But the analyses of these authors are not immediately relevant for health policy. It requires knowledge translation to make them so. This paper analyses the process of translation. The discussion is especially pertinent due to a certain looping effect between social science research and policy concerns. The case here presented is thus doubly illustrative: exemplifying first how social science is translated into health policy and secondly how the transformation required for this to function is taken as an analytical improvement that can in turn be redeployed in social research.

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...

Racial/ethnic differences in obesity and comorbidities between safety-net- and non safety-net integrated health systems

PubMed Central

Balasubramanian, Bijal A.; Garcia, Michael P.; Corley, Douglas A.; Doubeni, Chyke A.; Haas, Jennifer S.; Kamineni, Aruna; Quinn, Virginia P.; Wernli, Karen; Zheng, Yingye; Skinner, Celette Sugg

2017-01-01

Abstract Previous research shows that patients in integrated health systems experience fewer racial disparities compared with more traditional healthcare systems. Little is known about patterns of racial/ethnic disparities between safety-net and non safety-net integrated health systems. We evaluated racial/ethnic differences in body mass index (BMI) and the Charlson comorbidity index from 3 non safety-net- and 1 safety-net integrated health systems in a cross-sectional study. Multinomial logistic regression modeled comorbidity and BMI on race/ethnicity and health care system type adjusting for age, sex, insurance, and zip-code-level income The study included 1.38 million patients. Higher proportions of safety-net versus non safety-net patients had comorbidity score of 3+ (11.1% vs. 5.0%) and BMI ≥35 (27.7% vs. 15.8%). In both types of systems, blacks and Hispanics were more likely than whites to have higher BMIs. Whites were more likely than blacks or Hispanics to have higher comorbidity scores in a safety net system, but less likely to have higher scores in the non safety-nets. The odds of comorbidity score 3+ and BMI 35+ in blacks relative to whites were significantly lower in safety-net than in non safety-net settings. Racial/ethnic differences were present within both safety-net and non safety-net integrated health systems, but patterns differed. Understanding patterns of racial/ethnic differences in health outcomes in safety-net and non safety-net integrated health systems is important to tailor interventions to eliminate racial/ethnic disparities in health and health care. PMID:28296752

49 CFR 385.715 - Duration of safety monitoring system.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 5 2011-10-01 2011-10-01 false Duration of safety monitoring system. 385.715... SAFETY FITNESS PROCEDURES Safety Monitoring System for Non-North American Carriers § 385.715 Duration of safety monitoring system. (a) Each non-North America-domiciled carrier subject to this subpart will...

49 CFR 385.117 - Duration of safety monitoring system.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false Duration of safety monitoring system. 385.117... SAFETY FITNESS PROCEDURES Safety Monitoring System for Mexico-Domiciled Carriers § 385.117 Duration of safety monitoring system. (a) Each Mexico-domiciled carrier subject to this subpart will remain in the...

49 CFR 385.117 - Duration of safety monitoring system.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 5 2011-10-01 2011-10-01 false Duration of safety monitoring system. 385.117... SAFETY FITNESS PROCEDURES Safety Monitoring System for Mexico-Domiciled Carriers § 385.117 Duration of safety monitoring system. (a) Each Mexico-domiciled carrier subject to this subpart will remain in the...

49 CFR 385.715 - Duration of safety monitoring system.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false Duration of safety monitoring system. 385.715... SAFETY FITNESS PROCEDURES Safety Monitoring System for Non-North American Carriers § 385.715 Duration of safety monitoring system. (a) Each non-North America-domiciled carrier subject to this subpart will...

Critical Characteristics of Radiation Detection System Components to be Dedicated for use in Safety Class and Safety Significant System

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

DAVIS, S.J.

2000-05-25

This document identifies critical characteristics of components to be dedicated for use in Safety Class (SC) or Safety Significant (SS) Systems, Structures, or Components (SSCs). This document identifies the requirements for the components of the common radiation area monitor alarm in the WESF pool cell. These are procured as Commercial Grade Items (CGI), with the qualification testing and formal dedication to be performed at the Waste Encapsulation Storage Facility (WESF), in safety class, safety significant systems. System modifications are to be performed in accordance with the instructions provided on ECN 658230. Components for this change are commercially available and interchangeablemore » with the existing alarm configuration This document focuses on the operational requirements for alarm, declaration of the safety classification, identification of critical characteristics, and interpretation of requirements for procurement. Critical characteristics are identified herein and must be verified, followed by formal dedication, prior to the components being used in safety related applications.« less

Adverse drug event reporting systems: a systematic review

PubMed Central

Peddie, David; Wickham, Maeve E.; Badke, Katherin; Small, Serena S.; Doyle‐Waters, Mary M.; Balka, Ellen; Hohl, Corinne M.

2016-01-01

Aim Adverse drug events (ADEs) are harmful and unintended consequences of medications. Their reporting is essential for drug safety monitoring and research, but it has not been standardized internationally. Our aim was to synthesize information about the type and variety of data collected within ADE reporting systems. Methods We developed a systematic search strategy, applied it to four electronic databases, and completed an electronic grey literature search. Two authors reviewed titles and abstracts, and all eligible full‐texts. We extracted data using a standardized form, and discussed disagreements until reaching consensus. We synthesized data by collapsing data elements, eliminating duplicate fields and identifying relationships between reporting concepts and data fields using visual analysis software. Results We identified 108 ADE reporting systems containing 1782 unique data fields. We mapped them to 33 reporting concepts describing patient information, the ADE, concomitant and suspect drugs, and the reporter. While reporting concepts were fairly consistent, we found variability in data fields and corresponding response options. Few systems clarified the terminology used, and many used multiple drug and disease dictionaries such as the Medical Dictionary for Regulatory Activities (MedDRA). Conclusion We found substantial variability in the data fields used to report ADEs, limiting the comparability of ADE data collected using different reporting systems, and undermining efforts to aggregate data across cohorts. The development of a common standardized data set that can be evaluated with regard to data quality, comparability and reporting rates is likely to optimize ADE data and drug safety surveillance. PMID:27016266

Adverse drug event reporting systems: a systematic review.

PubMed

Bailey, Chantelle; Peddie, David; Wickham, Maeve E; Badke, Katherin; Small, Serena S; Doyle-Waters, Mary M; Balka, Ellen; Hohl, Corinne M

2016-07-01

Adverse drug events (ADEs) are harmful and unintended consequences of medications. Their reporting is essential for drug safety monitoring and research, but it has not been standardized internationally. Our aim was to synthesize information about the type and variety of data collected within ADE reporting systems. We developed a systematic search strategy, applied it to four electronic databases, and completed an electronic grey literature search. Two authors reviewed titles and abstracts, and all eligible full-texts. We extracted data using a standardized form, and discussed disagreements until reaching consensus. We synthesized data by collapsing data elements, eliminating duplicate fields and identifying relationships between reporting concepts and data fields using visual analysis software. We identified 108 ADE reporting systems containing 1782 unique data fields. We mapped them to 33 reporting concepts describing patient information, the ADE, concomitant and suspect drugs, and the reporter. While reporting concepts were fairly consistent, we found variability in data fields and corresponding response options. Few systems clarified the terminology used, and many used multiple drug and disease dictionaries such as the Medical Dictionary for Regulatory Activities (MedDRA). We found substantial variability in the data fields used to report ADEs, limiting the comparability of ADE data collected using different reporting systems, and undermining efforts to aggregate data across cohorts. The development of a common standardized data set that can be evaluated with regard to data quality, comparability and reporting rates is likely to optimize ADE data and drug safety surveillance. © 2016 The British Pharmacological Society.

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.

14 CFR 91.25 - Aviation Safety Reporting Program: Prohibition against use of reports for enforcement purposes.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 2 2011-01-01 2011-01-01 false Aviation Safety Reporting Program... AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIR TRAFFIC AND GENERAL OPERATING RULES GENERAL OPERATING AND FLIGHT RULES General § 91.25 Aviation Safety Reporting Program: Prohibition against...

14 CFR 91.25 - Aviation Safety Reporting Program: Prohibition against use of reports for enforcement purposes.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 2 2012-01-01 2012-01-01 false Aviation Safety Reporting Program... AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIR TRAFFIC AND GENERAL OPERATING RULES GENERAL OPERATING AND FLIGHT RULES General § 91.25 Aviation Safety Reporting Program: Prohibition against...

14 CFR 91.25 - Aviation Safety Reporting Program: Prohibition against use of reports for enforcement purposes.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 2 2014-01-01 2014-01-01 false Aviation Safety Reporting Program... AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIR TRAFFIC AND GENERAL OPERATING RULES GENERAL OPERATING AND FLIGHT RULES General § 91.25 Aviation Safety Reporting Program: Prohibition against...

14 CFR 91.25 - Aviation Safety Reporting Program: Prohibition against use of reports for enforcement purposes.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 2 2013-01-01 2013-01-01 false Aviation Safety Reporting Program... AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIR TRAFFIC AND GENERAL OPERATING RULES GENERAL OPERATING AND FLIGHT RULES General § 91.25 Aviation Safety Reporting Program: Prohibition against...

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)...

MedWatch, the FDA Safety Information and Adverse Event Reporting Program

MedlinePlus

... Information and Adverse Event Reporting Program MedWatch: The FDA Safety Information and Adverse Event Reporting Program Share ... use. [Posted 06/01/2018] More What's New FDA Approved Safety Information DailyMed (National Library of Medicine) ...

Analyzing Software Requirements Errors in Safety-Critical, Embedded Systems

NASA Technical Reports Server (NTRS)

Lutz, Robyn R.

1993-01-01

This paper analyzes the root causes of safety-related software errors in safety-critical, embedded systems. The results show that software errors identified as potentially hazardous to the system tend to be produced by different error mechanisms than non- safety-related software errors. Safety-related software errors are shown to arise most commonly from (1) discrepancies between the documented requirements specifications and the requirements needed for correct functioning of the system and (2) misunderstandings of the software's interface with the rest of the system. The paper uses these results to identify methods by which requirements errors can be prevented. The goal is to reduce safety-related software errors and to enhance the safety of complex, embedded systems.

77 FR 71561 - Health and Safety Data Reporting; Addition of Certain Chemicals

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-03

... be, incorporated into consumer products to report certain unpublished health and safety studies to... the submission of TSCA section 8(d) health and safety studies from processors and distributors of... be, incorporated into consumer products to report certain unpublished health and safety studies to...

Safety System Design for Technology Education. A Safety Guide for Technology Education Courses K-12.