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

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.

How Agricultural Media Cover Safety Compared with Periodicals in Two Other Hazardous Industries.

PubMed

Marolf, Amanda; Heiberger, Scott; Evans, James; Joseph, Lura

2017-01-26

This analysis featured a uniquely broad look at challenges and potentials for engaging agricultural and other industrial media more effectively in covering safety. It involved a content analysis of selected industry periodicals serving agriculture, mining, and transportation, which are three of the nation's most hazardous industries, in terms of human safety. Use of the social amplification of risk framework (SARF) provided insight on safety coverage. In particular, it tested previous research indicating that media coverage tends to amplify (increase) more than attenuate (decrease) a sense of risk. Analysis involved 18 periodicals (9 agriculture, 7 transportation, and 2 mining) spanning a five-year period from 2008 to 2012. Full-text digital analysis identified terms found in safety articles across all three industries. A manual review of articles revealed the quantity and nature of safety coverage within and among these industries. Results identified 528 safety-related articles published during the period. Transportation and mining periodicals averaged more than twice as many safety articles as the agricultural periodicals. The amount of coverage within the three industries also varied greatly. Findings on the nature of coverage supported previous media research within the SARF. Coverage across all three industries was clearly oriented more to amplifying than to attenuating risk. This study adds to the understanding of variations, commonalities, challenges, and potentials for enhancing safety coverage by media serving these three industries. It also provides direction for engaging industry media more effectively in the public safety mission. The authors recommend seven areas of opportunity for further research. Copyright© by the American Society of Agricultural Engineers.

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.

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

PubMed

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

2017-06-01

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

NASA Aviation Safety Reporting System (ASRS)

NASA Technical Reports Server (NTRS)

Connell, Linda

2011-01-01

The NASA Aviation Safety Reporting System (ASRS) collects, analyzes, and distributes de-identified safety information provided through confidentially submitted reports from frontline aviation personnel. Since its inception in 1976, the ASRS has collected over 900,000 reports and has never breached the identity of the people sharing their information about events or safety issues. From this volume of data, the ASRS has released over 5,500 aviation safety alerts concerning potential hazards and safety concerns. The ASRS processes these reports, evaluates the information, and provides de-identified report information through the online ASRS Database at http://asrs.arc.nasa.gov. The NASA ASRS is also a founding member of the International Confidential Aviation Safety Systems (ICASS) group which is a collection of other national aviation reporting systems throughout the world. The ASRS model has also been replicated for application to improving safety in railroad, medical, fire fighting, and other domains. This presentation \\vill discuss confidential, voluntary, and non-punitive reporting systems and their advantages in providing information for safety improvements.

NASA Aviation Safety Reporting System (ASRS)

NASA Technical Reports Server (NTRS)

Connell, Linda J.

2017-01-01

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

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

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

Not Available

1992-03-01

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

Quarterly report on Defense Nuclear Facilities Safety Board Recommendation 90-7 for the period ending December 31, 1992

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

Cash, R.J.; Dukelow, G.T.; Forbes, C.J.

1993-03-01

This is the seventh quarterly report on the progress of activities addressing safety issues associated with Hanford Site high-level radioactive waste tanks that contain ferrocyanide compounds. In the presence of oxidizing materials, such as nitrates or nitrites, ferrocyanide can be made to explode in the laboratory by heating it to high temperatures [above 285{degrees}C (545{degrees}F)]. In the mid 1950s approximately 140 metric tons of ferrocyanide were added to 24 underground high-level radioactive waste tanks. An implementation plan (Cash 1991) responding to the Defense Nuclear Facilities Safety Board Recommendation 90-7 (FR 1990) was issued in March 1991 describing the activities thatmore » were planned and underway to address each of the six parts of Recommendation 90-7. A revision to the original plan was transmitted to US Department of Energy by Westinghouse Hanford Company in December 1992. Milestones completed this quarter are described in this report. Contents of this report include: Introduction; Defense Nuclear Facilities Safety Board Implementation Plan Task Activities (Defense Nuclear Facilities Safety Board Recommendation for enhanced temperature measurement, Recommendation for continuous temperature monitoring, Recommendation for cover gas monitoring, Recommendation for ferrocyanide waste characterization, Recommendation for chemical reaction studies, and Recommendation for emergency response planning); Schedules; and References. All actions recommended by the Defense Nuclear Facilities Safety Board for emergency planning by Hanford Site emergency preparedness organizations have been completed.« less

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.

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.

Non-reporting of work injuries and aspects of jobsite safety climate and behavioral-based safety elements among carpenters in Washington State.

PubMed

Lipscomb, Hester J; Schoenfisch, Ashley L; Cameron, Wilfrid

2015-04-01

Declining work injury rates may reflect safer work conditions as well as under-reporting. Union carpenters were invited to participate in a mailed, cross-sectional survey designed to capture information about injury reporting practices. Prevalence of non-reporting and fear of repercussions for reporting were compared across exposure to behavioral-based safety elements and three domains of the Nordic Safety Climate Questionnaire (NOSACQ-50). The majority (>75%) of the 1,155 participants felt they could report work-related injuries to their supervisor without fear of retribution, and most felt that the majority of injuries on their jobsites got reported. However, nearly half indicated it was best not to report minor injuries, and felt pressures to use their private insurance for work injury care. The prevalence of non-reporting and fear of reporting increased markedly with poorer measures of management safety justice (NOSACQ-50). Formal and informal policies and practices on jobsites likely influence injury reporting. © 2015 Wiley Periodicals, Inc.

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.

[The Spanish National Health System patient safety strategy, results for the period 2005-2007].

PubMed

Terol, E; Agra, Y; Fernández-Maíllo, M M; Casal, J; Sierra, E; Bandrés, B; García, M J; del Peso, P

2008-12-01

In 2005 the Spanish National Health System (SNHS) implemented a strategy aimed at improving patient safety in Spanish healthcare centres. Promote and develop knowledge of patient safety and a patient safety culture among health professionals and patients; design and implement adverse event information and reporting systems for learning purposes; introduce recommended safe practices in SNHS centres; promote patient safety research and public and patient involvement in patient safety policies. An Institutional Technical Committee was created with representatives from all the Spanish regions. All national organizations involved in healthcare quality and patient safety took part in the project. The strategy follows the WHO World Alliance for Patient Safety and Council of Europe recommendations. Budget allocated in the period 2005-2007: approximately EUR35 million. Around 5,000 health professionals were educated in PS concepts. Several studies were conducted on: adverse events in Hospitals and Primary Care, as well as studies to obtain information on health professionals' perceptions on safety, the use of medications and the situation regarding hospital-acquired infections. All the regions have introduced safe clinical practices related with the strategy. The strategy has been implemented in all the Spanish regions. Awareness was raised among health professionals and the public. A network of alliances has been set up with the regions, universities, schools, agencies and other organizations supporting the strategy.

75 FR 1301 - Periodic Reporting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-11

... POSTAL REGULATORY COMMISSION 39 CFR Part 3050 [Docket No. RM2010-7; Order No. 372] Periodic... in the analytical methods approved for use in periodic reporting.\\1\\ Proposal Thirty would modify the... Analytical Principles Used in Periodic Reporting (Proposals Three through Nineteen), November 13, 2009, at 36...

76 FR 297 - Periodic Reporting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-04

... POSTAL REGULATORY COMMISSION 39 CFR Part 3050 [Docket No. RM2011-5; Order No. 625] Periodic... certain analytical methods used in periodic reporting. This action responds to a Postal Service rulemaking... changes in the analytical methods approved for use in periodic reporting.\\1\\ Four separate proposals...

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.

Aviation Safety Reporting System: Process and Procedures

NASA Technical Reports Server (NTRS)

Connell, Linda J.

1997-01-01

The Aviation Safety Reporting System (ASRS) was established in 1976 under an agreement between the Federal Aviation Administration (FAA) and the National Aeronautics and Space Administration (NASA). This cooperative safety program invites pilots, air traffic controllers, flight attendants, maintenance personnel, and others to voluntarily report to NASA any aviation incident or safety hazard. The FAA provides most of the program funding. NASA administers the program, sets its policies in consultation with the FAA and aviation community, and receives the reports submitted to the program. The FAA offers those who use the ASRS program two important reporting guarantees: confidentiality and limited immunity. Reports sent to ASRS are held in strict confidence. More than 350,000 reports have been submitted since the program's beginning without a single reporter's identity being revealed. ASRS removes all personal names and other potentially identifying information before entering reports into its database. This system is a very successful, proof-of-concept for gathering safety data in order to provide timely information about safety issues. The ASRS information is crucial to aviation safety efforts both nationally and internationally. It can be utilized as the first step in safety by providing the direction and content to informed policies, procedures, and research, especially human factors. The ASRS process and procedures will be presented as one model of safety reporting feedback systems.

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.

National Partnership for Maternal Safety: Consensus Bundle on Severe Hypertension During Pregnancy and the Postpartum Period.

PubMed

Bernstein, Peter S; Martin, James N; Barton, John R; Shields, Laurence E; Druzin, Maurice L; Scavone, Barbara M; Frost, Jennifer; Morton, Christine H; Ruhl, Catherine; Slager, Joan; Tsigas, Eleni Z; Jaffer, Sara; Menard, M Kathryn

2017-08-01

Complications arising from hypertensive disorders of pregnancy are among the leading causes of preventable severe maternal morbidity and mortality. Timely and appropriate treatment has the potential to significantly reduce hypertension-related complications. To assist health care providers in achieving this goal, this patient safety bundle provides guidance to coordinate and standardize the care provided to women with severe hypertension during pregnancy and the postpartum period. This is one of several patient safety bundles developed by multidisciplinary work groups of the National Partnership for Maternal Safety under the guidance of the Council on Patient Safety in Women's Health Care. These safety bundles outline critical clinical practices that should be implemented in every maternity care setting. Similar to other bundles that have been developed and promoted by the Partnership, the hypertension safety bundle is organized into four domains: Readiness, Recognition and Prevention, Response, and Reporting and Systems Learning. Although the bundle components may be adapted to meet the resources available in individual facilities, standardization within an institution is strongly encouraged. This commentary provides information to assist with bundle implementation.

NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

1979-01-01

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

40 CFR 65.166 - Periodic reports.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., including a halogen reduction device for a low-throughput transfer rack, is used to control emissions from storage vessels or low-throughput transfer racks, the periodic report shall identify and state the cause...-throughput transfer racks, periodic reports shall include the following information: (1) Periodic reports...

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...

2007 motor vehicle occupant safety survey. Volume 5, Child safety seat report

DOT National Transportation Integrated Search

2009-04-01

The 2007 Motor Vehicle Occupant Safety Survey (MVOSS) was the sixth in a series of periodic national telephone surveys on occupant protection issues conducted for the National Highway Traffic Safety Administration (NHTSA). Data collection was conduct...

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...

The aviation safety reporting system

NASA Technical Reports Server (NTRS)

Reynard, W. D.

1984-01-01

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

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

76 FR 52915 - Periodic Reporting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-24

... proposed changes in certain analytical methods used in periodic reporting. The proposed changes are... assignment of certain flat sorting operations; bias in mixed mail tallies; and Express Mail. Establishing... consider changes in the analytical methods approved for use in periodic reporting.\\1\\ \\1\\ Petition of the...

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

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...

Mathematics and statistics research progress report, period ending June 30, 1983

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

Beauchamp, J. J.; Denson, M. V.; Heath, M. T.

1983-08-01

This report is the twenty-sixth in the series of progress reports of Mathematics and Statistics Research of the Computer Sciences organization, Union Carbide Corporation Nuclear Division. Part A records research progress in analysis of large data sets, applied analysis, biometrics research, computational statistics, materials science applications, numerical linear algebra, and risk analysis. Collaboration and consulting with others throughout the Oak Ridge Department of Energy complex are recorded in Part B. Included are sections on biological sciences, energy, engineering, environmental sciences, health and safety, and safeguards. Part C summarizes the various educational activities in which the staff was engaged. Part Dmore » lists the presentations of research results, and Part E records the staff's other professional activities during the report period.« less

NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

1977-01-01

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

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...

Safety survey report EBR-II safety survey, ANL-west health protection, industrial safety and fire protection survey

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

Dunbar, K.A.

1972-01-10

A safety survey covering the disciplines of Reactor Safety, Nuclear Criticality Safety, Health Protection and Industrial Safety and Fire Protection was conducted at the ANL-West EBR-II FEF Complex during the period January 10-18, 1972. In addition, the entire ANL-West site was surveyed for Health Protection and Industrial Safety and Fire Protection. The survey was conducted by members of the AEC Chicago Operations Office, a member of RDT-HQ and a member of the RDT-ID site office. Eighteen recommendations resulted from the survey, eleven in the area of Industrial Safety and Fire Protection, five in the area of Reactor Safety and twomore » in the area of Nuclear Criticality Safety.« less

Infanrix hexa and sudden death: a review of the periodic safety update reports submitted to the European Medicines Agency.

PubMed

Puliyel, Jacob; Sathyamala, C

2018-01-01

There have been a number of spontaneous reports of sudden unexpected death soon after the administration of Infanrix hexa (combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenza type B vaccine). The manufacturer, GlaxoSmithKline (GSK), submits confidential periodic safety update reports (PSURs) on Infanrix hexa to the European Medicines Agency (EMA). The latest is the PSUR 19. Each PSUR contains an analysis of observed/expected sudden deaths, which shows that the number of observed deaths soon after immunisation is lower than that expected by chance. This commentary focuses on that aspect of the PSUR which has a bearing on policy decisions. We analysed the data provided in the PSURs. It is apparent that the deaths acknowledged in the PSUR 16 were deleted from the PSUR 19. The number of observed deaths soon after vaccination among children older than one year was significantly higher than that expected by chance once the deleted deaths were restored and included in the analysis. The manufacturer must explain the figures that have been submitted to the regulatory authorities. The procedures undertaken by the EMA to evaluate the manufacturer's claims in the PSUR need to be reviewed. The Drugs Controller General of India nearly automatically accepts drugs and vaccines approved by the EMA. There is a need to reappraise the reliance on due diligence by the EMA.

49 CFR 385.333 - What happens at the end of the 18-month safety monitoring period?

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.333 What happens at the end of the 18-month safety monitoring period? (a) If a safety audit has been performed within... the same basis as any other carrier. (d) If a safety audit or compliance review has not been performed...

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.

Learning from Taiwan patient-safety reporting system.

PubMed

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

2012-12-01

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

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...

40 CFR 79.5 - Periodic reporting requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 17 2014-07-01 2014-07-01 false Periodic reporting requirements. 79.5...) REGISTRATION OF FUELS AND FUEL ADDITIVES General Provisions § 79.5 Periodic reporting requirements. (a) Fuel... table: Table 1 to § 79.5—Quarterly Reporting Deadlines Calendar quarter Time period covered Quartely...

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...

75 FR 38757 - Periodic Reporting Exceptions

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-06

... POSTAL REGULATORY COMMISSION 39 CFR 3055 [Docket No. RM2010-11; Order No. 481] Periodic Reporting...-permanent exceptions to certain rules on periodic reporting of service performance measurement. DATES... 202-789-6820 or [email protected] . SUPPLEMENTARY INFORMATION: Table of Contents I...

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.

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.

77 FR 21782 - International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-11

... electronic submission of individual case safety reports to regulatory authorities, automated data mining... Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum...

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

Mathematics and Statistics Research Department progress report, period ending June 30, 1982

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

Denson, M.V.; Funderlic, R.E.; Gosslee, D.G.

1982-08-01

This report is the twenty-fifth in the series of progress reports of the Mathematics and Statistics Research Department of the Computer Sciences Division, Union Carbide Corporation Nuclear Division (UCC-ND). Part A records research progress in analysis of large data sets, biometrics research, computational statistics, materials science applications, moving boundary problems, numerical linear algebra, and risk analysis. Collaboration and consulting with others throughout the UCC-ND complex are recorded in Part B. Included are sections on biology, chemistry, energy, engineering, environmental sciences, health and safety, materials science, safeguards, surveys, and the waste storage program. Part C summarizes the various educational activities inmore » which the staff was engaged. Part D lists the presentations of research results, and Part E records the staff's other professional activities during the report period.« less

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.

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.

Analytical Chemistry Division annual progress report for period ending December 31, 1989

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

Not Available

1990-04-01

The Analytical Chemistry Division of Oak Ridge National Laboratory (ORNL) is a large and diversified organization. As such, it serves a multitude of functions for a clientele that exists both in and outside of ORNL. These functions fall into the following general categories: Analytical Research, Development and Implementation; Programmatic Research, Development, and Utilization; and Technical Support. The Analytical Chemistry Division is organized into four major sections, each which may carry out any of the three types of work mentioned above. Chapters 1 through 4 of this report highlight progress within the four sections during the period January 1 to Decembermore » 31, 1989. A brief discussion of the division's role in an especially important environmental program is given in Chapter 5. Information about quality assurance, safety, and training programs is presented in Chapter 6, along with a tabulation of analyses rendered. Publications, oral presentations, professional activities, educational programs, and seminars are cited in Chapters 7 and 8. Approximately 69 articles, 41 proceedings, and 31 reports were published, and 151 oral presentations were given during this reporting period. Some 308,981 determinations were performed.« less

Mathematics and statistics research department. Progress report, period ending June 30, 1981

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

Lever, W.E.; Kane, V.E.; Scott, D.S.

1981-09-01

This report is the twenty-fourth in the series of progress reports of the Mathematics and Statistics Research Department of the Computer Sciences Division, Union Carbide Corporation - Nuclear Division (UCC-ND). Part A records research progress in biometrics research, materials science applications, model evaluation, moving boundary problems, multivariate analysis, numerical linear algebra, risk analysis, and complementary areas. Collaboration and consulting with others throughout the UCC-ND complex are recorded in Part B. Included are sections on biology and health sciences, chemistry, energy, engineering, environmental sciences, health and safety research, materials sciences, safeguards, surveys, and uranium resource evaluation. Part C summarizes the variousmore » educational activities in which the staff was engaged. Part D lists the presentations of research results, and Part E records the staff's other professional activities during the report period.« less

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...

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...

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 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.

Overview of Energy Systems' safety analysis report programs

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

Not Available

1992-03-01

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

NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

1976-01-01

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

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.

Avation Safety Reporting System (ASRS) 40th Anniversary

NASA Image and Video Library

2016-09-28

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

The NASA Aviation Safety Reporting System

NASA Technical Reports Server (NTRS)

1983-01-01

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

EMS helicopter incidents reported to the NASA Aviation Safety Reporting System

NASA Technical Reports Server (NTRS)

Connell, Linda J.; Reynard, William D.

1993-01-01

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

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

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...

Work stress and patient safety: observer-rated work stressors as predictors of characteristics of safety-related events reported by young nurses.

PubMed

Elfering, A; Semmer, N K; Grebner, S

This study investigates the link between workplace stress and the 'non-singularity' of patient safety-related incidents in the hospital setting. Over a period of 2 working weeks 23 young nurses from 19 hospitals in Switzerland documented 314 daily stressful events using a self-observation method (pocket diaries); 62 events were related to patient safety. Familiarity of safety-related events and probability of recurrence, as indicators of non-singularity, were the dependent variables in multilevel regression analyses. Predictor variables were both situational (self-reported situational control, safety compliance) and chronic variables (job stressors such as time pressure, or concentration demands and job control). Chronic work characteristics were rated by trained observers. The most frequent safety-related stressful events included incomplete or incorrect documentation (40.3%), medication errors (near misses 21%), delays in delivery of patient care (9.7%), and violent patients (9.7%). Familiarity of events and probability of recurrence were significantly predicted by chronic job stressors and low job control in multilevel regression analyses. Job stressors and low job control were shown to be risk factors for patient safety. The results suggest that job redesign to enhance job control and decrease job stressors may be an important intervention to increase patient safety.

Safety analysis and review system (SARS) assessment report

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

Browne, E.T.

1981-03-01

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

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...

2007 motor vehicle occupant safety survey. Volume 1, Methodology report

DOT National Transportation Integrated Search

2008-07-01

The 2007 Motor Vehicle Occupant Safety Survey was the sixth in a series of periodic national telephone surveys on occupant protection issues conducted for the National Highway Traffic Safety Administration (NHTSA). Data collection was conducted by Sc...

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…

Safety in the Chemical Laboratory: Safety in the Chemistry Laboratories: A Specific Program.

ERIC Educational Resources Information Center

Corkern, Walter H.; Munchausen, Linda L.

1983-01-01

Describes a safety program adopted by Southeastern Louisiana University. Students are given detailed instructions on laboratory safety during the first laboratory period and a test which must be completely correct before they are allowed to return to the laboratory. Test questions, list of safety rules, and a laboratory accident report form are…

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.

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…

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...

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.

The complexity of patient safety reporting systems in UK dentistry.

PubMed

Renton, T; Master, S

2016-10-21

Since the 'Francis Report', UK regulation focusing on patient safety has significantly changed. Healthcare workers are increasingly involved in NHS England patient safety initiatives aimed at improving reporting and learning from patient safety incidents (PSIs). Unfortunately, dentistry remains 'isolated' from these main events and continues to have a poor record for reporting and learning from PSIs and other events, thus limiting improvement of patient safety in dentistry. The reasons for this situation are complex.This paper provides a review of the complexities of the existing systems and procedures in relation to patient safety in dentistry. It highlights the conflicting advice which is available and which further complicates an overly burdensome process. Recommendations are made to address these problems with systems and procedures supporting patient safety development in dentistry.

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.

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.

77 FR 41336 - Analytical Methods Used in Periodic Reporting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-13

... Methods Used in Periodic Reporting AGENCY: Postal Regulatory Commission. ACTION: Notice of filing. SUMMARY... proceeding to consider changes in analytical methods used in periodic reporting. This notice addresses... informal rulemaking proceeding to consider changes in the analytical methods approved for use in periodic...

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.

New Automated System Available for Reporting Safety Concerns | Poster

Cancer.gov

A new system has been developed for reporting safety issues in the workplace. The Environment, Health, and Safety’s (EHS’) Safety Inspection and Issue Management System (SIIMS) is an online resource where any employee can report a problem or issue, said Siobhan Tierney, program manager at EHS.

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...

76 FR 80312 - Periodic Reporting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-23

... establishing a docket to consider new measurement of Flats Sequencing Systems operations, a change in the... Mail cost model in periodic reporting of service performance measurement. Establishing this docket will...: proposed productivity measurement for Flats Sequencing System. Proposal Sixteen introduces a new method for...

Electronic clinical safety reporting system: a benefits evaluation.

PubMed

Elliott, Pamela; Martin, Desmond; Neville, Doreen

2014-06-11

Eastern Health, a large health care organization in Newfoundland and Labrador (NL), started a staged implementation of an electronic occurrence reporting system (used interchangeably with "clinical safety reporting system") in 2008, completing Phase One in 2009. The electronic clinical safety reporting system (CSRS) was designed to replace a paper-based system. The CSRS involves reporting on occurrences such as falls, safety/security issues, medication errors, treatment and procedural mishaps, medical equipment malfunctions, and close calls. The electronic system was purchased from a vendor in the United Kingdom that had implemented the system in the United Kingdom and other places, such as British Columbia. The main objective of the new system was to improve the reporting process with the goal of improving clinical safety. The project was funded jointly by Eastern Health and Canada Health Infoway. The objectives of the evaluation were to: (1) assess the CSRS on achieving its stated objectives (particularly, the benefits realized and lessons learned), and (2) identify contributions, if any, that can be made to the emerging field of electronic clinical safety reporting. The evaluation involved mixed methods, including extensive stakeholder participation, pre/post comparative study design, and triangulation of data where possible. The data were collected from several sources, such as project documentation, occurrence reporting records, stakeholder workshops, surveys, focus groups, and key informant interviews. The findings provided evidence that frontline staff and managers support the CSRS, identifying both benefits and areas for improvement. Many benefits were realized, such as increases in the number of occurrences reported, in occurrences reported within 48 hours, in occurrences reported by staff other than registered nurses, in close calls reported, and improved timelines for notification. There was also user satisfaction with the tool regarding ease of use

2007 motor vehicle occupant safety survey. Volume 3, air bags report

DOT National Transportation Integrated Search

2008-11-01

The 2007 Motor Vehicle Occupant Safety Survey was the sixth in a series of periodic national telephone surveys on occupant : protection issues conducted for the National Highway Traffic Safety Administration (NHTSA). Data collection was conducted : b...

2007 motor vehicle occupant safety survey. Volume 2, Seat belt report

DOT National Transportation Integrated Search

2008-07-01

The 2007 Motor Vehicle Occupant Safety Survey was the sixth in a series of periodic national telephone surveys on occupant protection issues conducted for the National Highway Traffic Safety Administration (NHTSA). Data collection was conducted by Sc...

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.

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

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...

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...

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...

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.

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...

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)

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

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

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.

26 CFR 301.6059-1 - Periodic report of actuary.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 26 Internal Revenue 18 2014-04-01 2014-04-01 false Periodic report of actuary. 301.6059-1 Section...-1 Periodic report of actuary. (a) In general. The actuarial report described in this section must be... funding deficiency (as defined in section 412(a)) to zero, (4) A statement by the enrolled actuary signing...

26 CFR 301.6059-1 - Periodic report of actuary.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 26 Internal Revenue 18 2012-04-01 2012-04-01 false Periodic report of actuary. 301.6059-1 Section...-1 Periodic report of actuary. (a) In general. The actuarial report described in this section must be... funding deficiency (as defined in section 412(a)) to zero, (4) A statement by the enrolled actuary signing...

26 CFR 301.6059-1 - Periodic report of actuary.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 26 Internal Revenue 18 2013-04-01 2013-04-01 false Periodic report of actuary. 301.6059-1 Section...-1 Periodic report of actuary. (a) In general. The actuarial report described in this section must be... funding deficiency (as defined in section 412(a)) to zero, (4) A statement by the enrolled actuary signing...

26 CFR 301.6059-1 - Periodic report of actuary.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 18 2011-04-01 2011-04-01 false Periodic report of actuary. 301.6059-1 Section...-1 Periodic report of actuary. (a) In general. The actuarial report described in this section must be... funding deficiency (as defined in section 412(a)) to zero, (4) A statement by the enrolled actuary signing...

26 CFR 301.6059-1 - Periodic report of actuary.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 18 2010-04-01 2010-04-01 false Periodic report of actuary. 301.6059-1 Section...-1 Periodic report of actuary. (a) In general. The actuarial report described in this section must be... funding deficiency (as defined in section 412(a)) to zero, (4) A statement by the enrolled actuary signing...

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.

Health and Safety Research Division progress report, October 1, 1988--March 31, 1990

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

Not Available

1990-09-01

The Health and Safety Research Division (HASRD) of the Oak Ridge National Laboratory (ORNL) continues to maintain an outstanding program of basic and applied research displaying a high level of creativity and achievement as documented by awards, publications, professional service, and successful completion of variety of projects. Our focus is on human health and the scientific basis for measurement and assessment of health-related impacts of energy technologies. It is our custom to publish a division progress report every 18 months that summarizes our programmatic progress and other measures of achievement over the reporting period. Since it is not feasible tomore » summarize in detail all of our work over the period covered by this report (October 1, 1988, to March 30, 1990), we intend this document to point the way to the expensive open literature that documents our findings. During the reporting period the Division continued to maintain strong programs in its traditional areas of R D, but also achieved noteworthy progress in other areas. Much of the Division's work on site characterization, development of new field instruments, compilation of data bases, and methodology development fits into this initiative. Other new work in tunneling microscopy in support of DOE's Human Genome Program and the comprehensive R D work related to surface-enhanced Raman spectroscopy have attained new and exciting results. These examples of our progress and numerous other activities are highlighted in this report.« less

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.

NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

1981-01-01

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

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

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 ...

75 FR 41531 - Brookwood-Sago Mine Safety Grants

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-16

... stated goals and current reporting period. objectives for improving safety. Conduct and report pre-test and post- test results of trainees. Course evaluations of trainer and training materials. The extent... pre-test and post- and improves safety. educational materials test results of the training materials...

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...

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 :...

77 FR 56176 - Analytical Methods Used in Periodic Reporting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-12

... POSTAL REGULATORY COMMISSION 39 CFR Part 3001 [Docket No. RM2012-7; Order No. 1459] Analytical Methods Used in Periodic Reporting AGENCY: Postal Regulatory Commission. ACTION: Notice of proposed... analytical methods approved for use in periodic reporting.\\1\\ \\1\\ Petition of the United States Postal...

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.

Aerospace Safety Advisory Panel

NASA Technical Reports Server (NTRS)

1993-01-01

The Aerospace Safety Advisory Panel (ASAP) provided oversight on the safety aspects of many NASA programs. In addition, ASAP undertook three special studies. At the request of the Administrator, the panel assessed the requirements for an assured crew return vehicle (ACRV) for the space station and reviewed the organization of the safety and mission quality function within NASA. At the behest of Congress, the panel formed an independent, ad hoc working group to examine the safety and reliability of the space shuttle main engine. Section 2 presents findings and recommendations. Section 3 consists of information in support of these findings and recommendations. Appendices A, B, C, and D, respectively, cover the panel membership, the NASA response to the findings and recommendations in the March 1992 report, a chronology of the panel's activities during the reporting period, and the entire ACRV study report.

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.

Safety and Effectiveness of Natalizumab: First Report of Interim Results of Post-Marketing Surveillance in Japan.

PubMed

Saida, Takahiko; Yokoyama, Kazumasa; Sato, Ryusuke; Makioka, Haruki; Iizuka, Yukihiko; Hase, Masakazu; Ling, Yan; Torii, Shinichi

2017-12-01

Natalizumab, a humanized anti-α4 integrin monoclonal antibody, received marketing approval in Japan in 2014 for the treatment of multiple sclerosis (MS). Because the previous large-scale clinical trials of natalizumab were mainly conducted in Europe and North American countries, and data in patients with MS from Japan were limited, we conducted an all-case post-marketing surveillance of natalizumab-treated MS patients from Japan to investigate the safety and effectiveness of natalizumab in a real-world clinical setting in Japan. Here, we report the results of an interim analysis. During the observation period of 2 years, all patients who were treated with natalizumab subsequent to its approval in Japan were followed. The effectiveness of natalizumab was assessed by examining the changes in expanded disability status scale (EDSS) score and annualized relapse rate (ARR) from baseline. Safety was assessed by analyzing the incidence of adverse drug reactions (ADRs). The safety analysis included 106 patients (mean age 39.3 years; women 62.3%) whose data were collected until the data lock point (February 7, 2016). The effectiveness analysis included 75 patients. The majority of patients had relapsing-remitting MS (93/106 patients; 87.7%). The mean length of treatment exposure in the present study was 6.6 months. During the 2-year observation period, no significant change in the EDSS was observed, while the ARR decreased significantly from baseline (72.9% reduction, p = 0.001). ADRs and serious ADRs were observed in 11.3% and 3.8% of patients, respectively; however, no new safety concerns were detected. No patient had progressive multifocal leukoencephalopathy (PML) during the present study period. The safety and effectiveness of natalizumab were confirmed in Japanese patients with MS in clinical practice. Nevertheless, potential risks including PML require continuous, careful observation. Biogen Japan Ltd (Tokyo, Japan).

How might health services capture patient-reported safety concerns in a hospital setting? An exploratory pilot study of three mechanisms.

PubMed

O'Hara, Jane Kathryn; Armitage, Gerry; Reynolds, Caroline; Coulson, Claire; Thorp, Liz; Din, Ikhlaq; Watt, Ian; Wright, John

2017-01-01

Emergent evidence suggests that patients can identify and report safety issues while in hospital. However, little is known about the best method for collecting information from patients about safety concerns. This study presents an exploratory pilot of three mechanisms for collecting data on safety concerns from patients during their hospital stay. Three mechanisms for capturing safety concerns were coproduced with healthcare professionals and patients, before being tested in an exploratory trial using cluster randomisation at the ward level. Nine wards participated, with each mechanism being tested over a 3-month study period. Patients were asked to feed back safety concerns via the mechanism on their ward (interviewing at their bedside, paper-based form or patient safety 'hotline'). Safety concerns were subjected to a two-stage review process to identify those that would meet the definition of a patient safety incident. Differences between mechanisms on a range of outcomes were analysed using inferential statistics. Safety concerns were thematically analysed to develop reporting categories. 178 patients were recruited. Patients in the face-to-face interviewing condition provided significantly more safety concerns per patient (1.91) compared with the paper-based form (0.92) and the patient safety hotline (0.43). They were also significantly more likely to report one or more concerns, with 64% reporting via the face-to-face mechanism, compared with 41% via the paper-based form and 19% via the patient safety hotline. No mechanism differed significantly in the number of classified patient safety incidents or physician-rated preventability and severity. Interviewing at the patient's bedside is likely to be the most effective means of gathering safety concerns from inpatients, potentially providing an opportunity for health services to gather patient feedback about safety from their perspective. Published by the BMJ Publishing Group Limited. For permission to use

40 CFR 79.5 - Periodic reporting requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) REGISTRATION OF FUELS AND FUEL ADDITIVES General Provisions § 79.5 Periodic reporting requirements. (a) Fuel..., October through December) commencing after the date prescribed for a particular fuel in subpart D, fuel manufacturers shall submit to the Administrator a report for each registered fuel showing (i) the range of...

40 CFR 79.5 - Periodic reporting requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) REGISTRATION OF FUELS AND FUEL ADDITIVES General Provisions § 79.5 Periodic reporting requirements. (a) Fuel..., October through December) commencing after the date prescribed for a particular fuel in subpart D, fuel manufacturers shall submit to the Administrator a report for each registered fuel showing (i) the range of...

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...

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.

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) ...

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...

Monitoring product safety in the postmarketing environment.

PubMed

Sharrar, Robert G; Dieck, Gretchen S

2013-10-01

The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.

7 CFR 981.73 - Periodic reports.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 8 2010-01-01 2010-01-01 false Periodic reports. 981.73 Section 981.73 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements and Orders; Fruits, Vegetables, Nuts), DEPARTMENT OF AGRICULTURE ALMONDS GROWN IN CALIFORNIA Order...

Creating the Web-based Intensive Care Unit Safety Reporting System

PubMed Central

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

2005-01-01

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

21 CFR 312.32 - IND safety reporting.

Code of Federal Regulations, 2014 CFR

2014-04-01

... testing. The sponsor must report any findings from animal or in vitro testing, whether or not conducted by... 21 Food and Drugs 5 2014-04-01 2014-04-01 false IND safety reporting. 312.32 Section 312.32 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR...

12 CFR 563g.18 - Current and periodic reports.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 5 2010-01-01 2010-01-01 false Current and periodic reports. 563g.18 Section 563g.18 Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE TREASURY SECURITIES OFFERINGS § 563g.18 Current and periodic reports. (a) Each savings association which files an offering circular...

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

PubMed

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

2016-03-01

Although the reporting of adverse events is a necessary first step in identifying and addressing lapses in patient safety, such events are under-reported, especially by frontline providers such as resident physicians. This study describes and tests relationships between power distance and leader inclusiveness on psychological safety and the willingness of residents to report adverse events. A total of 106 resident physicians from the departments of neurosurgery, orthopaedic surgery, emergency medicine, otolaryngology, neurology, obstetrics and gynaecology, paediatrics and general surgery in a mid-Atlantic teaching hospital were asked to complete a survey on psychological safety, perceived power distance, leader inclusiveness and intention to report adverse events. Perceived power distance (β = -0.26, standard error [SE] 0.06, 95% confidence interval [CI] -0.37 to 0.15; p < 0.001) and leader inclusiveness (β = 0.51; SE 0.07, 95% CI 0.38-0.65; p < 0.001) both significantly predicted psychological safety, which, in turn, significantly predicted intention to report adverse events (β = 0.34; SE 0.08, 95% CI 0.18-0.49; p < 0.001). Psychological safety significantly mediated the direct relationship between power distance and intention to report adverse events (indirect effect: -0.09; SE 0.02, 95% CI -0.13 to 0.04; p < 0.001). Psychological safety also significantly mediated the direct relationship between leader inclusiveness and intention to report adverse events (indirect effect: 0.17; SE 0.02, 95% CI 0.08-0.27; p = 0.001). Psychological safety was found to be a predictor of intention to report adverse events. Perceived power distance and leader inclusiveness both influenced the reporting of adverse events through the concept of psychological safety. Because adverse event reporting is shaped by relationships and culture external to the individual, it should be viewed as an organisational as much as a personal function. Supervisors and other leaders in health care

President's Child Safety Partnership. Final Report.

ERIC Educational Resources Information Center

President's Commission on Child Safety Partnership, Washington, DC.

This report presents the findings and recommendations from the President's Child Safety Partnership, a group of citizens representing business, private nonprofit groups, the government, and private individuals appointed by President Reagan to gather accurate information about the nature and extent of violence against children and to identify…

A Bibliographic Guide to Occupational Safety and Health.

ERIC Educational Resources Information Center

Pease, Sue

1981-01-01

Lists government publications, periodicals, loose-leaf services, reports, and reference materials dealing with health and safety in the work environment. Addresses for the Occupational Safety and Health Administration regional offices are provided. (FM)

Factors related to increasing safety belt use in states with safety belt use laws : second annual report to Congress, 1988.

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 ...

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

Delaware highway safety annual report : FY 2009

DOT National Transportation Integrated Search

2009-01-01

The Fiscal Year 2009 Annual Evaluation Report reflects our major : accomplishments in impacting our priority areas, and highlights the : programming initiatives undertaken to increase public awareness about : highway safety. Throughout the coming yea...

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.

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.

An observational survey of safety belt and child safety seat use in Virginia : final report : the 1990 update.

DOT National Transportation Integrated Search

1992-01-01

This report was prepared in response to a request from the Transportation Safety Administration of the Virginia Department ofMotor Vehicles for data concerning the use of safety belts and child safety seats by the occupants of vehicles bearing Virgin...

Associations between safety climate and safety management practices in the construction industry.

PubMed

Marín, Luz S; Lipscomb, Hester; Cifuentes, Manuel; Punnett, Laura

2017-06-01

Safety climate, a group-level measure of workers' perceptions regarding management's safety priorities, has been suggested as a key predictor of safety outcomes. However, its relationship with actual injury rates is inconsistent. We posit that safety climate may instead be a parallel outcome of workplace safety practices, rather than a determinant of workers' safety behaviors or outcomes. Using a sample of 25 commercial construction companies in Colombia, selected by injury rate stratum (high, medium, low), we examined the relationship between workers' safety climate perceptions and safety management practices (SMPs) reported by safety officers. Workers' perceptions of safety climate were independent of their own company's implementation of SMPs, as measured here, and its injury rates. However, injury rates were negatively related to the implementation of SMPs. Safety management practices may be more important than workers' perceptions of safety climate as direct predictors of injury rates. © 2017 Wiley Periodicals, Inc.

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.

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

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),...

17 CFR 287.2 - Periodic reports.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 17 Commodity and Securities Exchanges 3 2012-04-01 2012-04-01 false Periodic reports. 287.2 Section 287.2 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION (CONTINUED) Schedule A to Part 285 GENERAL RULES AND REGULATIONS PURSUANT TO SECTION 11(a) OF THE ASIAN DEVELOPMENT BANK ACT...

17 CFR 287.2 - Periodic reports.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Periodic reports. 287.2 Section 287.2 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION (CONTINUED) Schedule A to Part 285 GENERAL RULES AND REGULATIONS PURSUANT TO SECTION 11(a) OF THE ASIAN DEVELOPMENT BANK ACT...

17 CFR 287.2 - Periodic reports.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 17 Commodity and Securities Exchanges 3 2013-04-01 2013-04-01 false Periodic reports. 287.2 Section 287.2 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION (CONTINUED) Schedule A to Part 285 GENERAL RULES AND REGULATIONS PURSUANT TO SECTION 11(a) OF THE ASIAN DEVELOPMENT BANK ACT...

17 CFR 287.2 - Periodic reports.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 17 Commodity and Securities Exchanges 3 2011-04-01 2011-04-01 false Periodic reports. 287.2 Section 287.2 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION (CONTINUED) Schedule A to Part 285 GENERAL RULES AND REGULATIONS PURSUANT TO SECTION 11(a) OF THE ASIAN DEVELOPMENT BANK ACT...

17 CFR 287.2 - Periodic reports.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 17 Commodity and Securities Exchanges 4 2014-04-01 2014-04-01 false Periodic reports. 287.2 Section 287.2 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION (CONTINUED) Schedule A to Part 285 GENERAL RULES AND REGULATIONS PURSUANT TO SECTION 11(a) OF THE ASIAN DEVELOPMENT BANK ACT...

40 CFR 61.275 - Periodic report.

Code of Federal Regulations, 2013 CFR

2013-07-01

... EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS National Emission Standard for Benzene Emissions From Benzene Storage Vessels § 61.275 Periodic report. (a) The owner or operator of each storage vessel to... storage vessel in which: (i) The internal floating roof is not resting on the surface of the benzene...

40 CFR 61.275 - Periodic report.

Code of Federal Regulations, 2012 CFR

2012-07-01

... EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS National Emission Standard for Benzene Emissions From Benzene Storage Vessels § 61.275 Periodic report. (a) The owner or operator of each storage vessel to... storage vessel in which: (i) The internal floating roof is not resting on the surface of the benzene...

40 CFR 61.275 - Periodic report.

Code of Federal Regulations, 2014 CFR

2014-07-01

... EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS National Emission Standard for Benzene Emissions From Benzene Storage Vessels § 61.275 Periodic report. (a) The owner or operator of each storage vessel to... storage vessel in which: (i) The internal floating roof is not resting on the surface of the benzene...

40 CFR 61.275 - Periodic report.

Code of Federal Regulations, 2011 CFR

2011-07-01

... EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS National Emission Standard for Benzene Emissions From Benzene Storage Vessels § 61.275 Periodic report. (a) The owner or operator of each storage vessel to... storage vessel in which: (i) The internal floating roof is not resting on the surface of the benzene...

Management of radioactive material safety programs at medical facilities. Final report

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

Camper, L.W.; Schlueter, J.; Woods, S.

A Task Force, comprising eight US Nuclear Regulatory Commission and two Agreement State program staff members, developed the guidance contained in this report. This report describes a systematic approach for effectively managing radiation safety programs at medical facilities. This is accomplished by defining and emphasizing the roles of an institution`s executive management, radiation safety committee, and radiation safety officer. Various aspects of program management are discussed and guidance is offered on selecting the radiation safety officer, determining adequate resources for the program, using such contractual services as consultants and service companies, conducting audits, and establishing the roles of authorized usersmore » and supervised individuals; NRC`s reporting and notification requirements are discussed, and a general description is given of how NRC`s licensing, inspection and enforcement programs work.« less

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.

14 CFR Appendix J to Part 417 - Ground Safety Analysis Report

Code of Federal Regulations, 2014 CFR

2014-01-01

... information required by this appendix. J417.3Ground safety analysis report chapters (a) Introduction. A ground... analysis report must include a chapter that provides detailed safety information about each launch vehicle... data. A hazard analysis form must contain or reference all information necessary to understand the...

14 CFR Appendix J to Part 417 - Ground Safety Analysis Report

Code of Federal Regulations, 2013 CFR

2013-01-01

... information required by this appendix. J417.3Ground safety analysis report chapters (a) Introduction. A ground... analysis report must include a chapter that provides detailed safety information about each launch vehicle... data. A hazard analysis form must contain or reference all information necessary to understand the...

14 CFR Appendix J to Part 417 - Ground Safety Analysis Report

Code of Federal Regulations, 2010 CFR

2010-01-01

... information required by this appendix. J417.3Ground safety analysis report chapters (a) Introduction. A ground... analysis report must include a chapter that provides detailed safety information about each launch vehicle... data. A hazard analysis form must contain or reference all information necessary to understand the...

14 CFR Appendix J to Part 417 - Ground Safety Analysis Report

Code of Federal Regulations, 2011 CFR

2011-01-01

... information required by this appendix. J417.3Ground safety analysis report chapters (a) Introduction. A ground... analysis report must include a chapter that provides detailed safety information about each launch vehicle... data. A hazard analysis form must contain or reference all information necessary to understand the...

14 CFR Appendix J to Part 417 - Ground Safety Analysis Report

Code of Federal Regulations, 2012 CFR

2012-01-01

... information required by this appendix. J417.3Ground safety analysis report chapters (a) Introduction. A ground... analysis report must include a chapter that provides detailed safety information about each launch vehicle... data. A hazard analysis form must contain or reference all information necessary to understand the...

National Dam Safety Program. Lipps Lake Dam (MO 30214). Mississippi - Kaskaskia - St. Louis Basin, Cape Girardeau County, Missouri. Phase I Inspection Report.

DTIC Science & Technology

1980-10-01

AD-A105 988 HOSKINSEWESTERN-SONOER EGGER INC LINCOLN NEM F/S 13/13 NATIONAL DA -M SAFETY PROGRAM. LI PS LAKE DAM (MO 3021 ). MISS! SS7 - TC(U...COMPLETING FORM i. REPORT NUMBER 12. GOVT ACCESSION NO. 3. RECIPIENT’S CATALOG NIOMBER 4. TITLE (and Subtitle) 5. TYPE OF REPORT & PERIOD COVERED Phase I Dam

Error reporting in transfusion medicine at a tertiary care centre: a patient safety initiative.

PubMed

Elhence, Priti; Shenoy, Veena; Verma, Anupam; Sachan, Deepti

2012-11-01

Errors in the transfusion process can compromise patient safety. A study was undertaken at our center to identify the errors in the transfusion process and their causes in order to reduce their occurrence by corrective and preventive actions. All near miss, no harm events and adverse events reported in the 'transfusion process' during 1 year study period were recorded, classified and analyzed at a tertiary care teaching hospital in North India. In total, 285 transfusion related events were reported during the study period. Of these, there were four adverse (1.5%), 10 no harm (3.5%) and 271 (95%) near miss events. Incorrect blood component transfusion rate was 1 in 6031 component units. ABO incompatible transfusion rate was one in 15,077 component units issued or one in 26,200 PRBC units issued and acute hemolytic transfusion reaction due to ABO incompatible transfusion was 1 in 60,309 component units issued. Fifty-three percent of the antecedent near miss events were bedside events. Patient sample handling errors were the single largest category of errors (n=94, 33%) followed by errors in labeling and blood component handling and storage in user areas. The actual and near miss event data obtained through this initiative provided us with clear evidence about latent defects and critical points in the transfusion process so that corrective and preventive actions could be taken to reduce errors and improve transfusion safety.

Correlation between safety climate and contractor safety assessment programs in construction.

PubMed

Sparer, Emily H; Murphy, Lauren A; Taylor, Kathryn M; Dennerlein, Jack T

2013-12-01

Contractor safety assessment programs (CSAPs) measure safety performance by integrating multiple data sources together; however, the relationship between these measures of safety performance and safety climate within the construction industry is unknown. Four hundred and one construction workers employed by 68 companies on 26 sites and 11 safety managers employed by 11 companies completed brief surveys containing a nine-item safety climate scale developed for the construction industry. CSAP scores from ConstructSecure, Inc., an online CSAP database, classified these 68 companies as high or low scorers, with the median score of the sample population as the threshold. Spearman rank correlations evaluated the association between the CSAP score and the safety climate score at the individual level, as well as with various grouping methodologies. In addition, Spearman correlations evaluated the comparison between manager-assessed safety climate and worker-assessed safety climate. There were no statistically significant differences between safety climate scores reported by workers in the high and low CSAP groups. There were, at best, weak correlations between workers' safety climate scores and the company CSAP scores, with marginal statistical significance with two groupings of the data. There were also no significant differences between the manager-assessed safety climate and the worker-assessed safety climate scores. A CSAP safety performance score does not appear to capture safety climate, as measured in this study. The nature of safety climate in construction is complex, which may be reflective of the challenges in measuring safety climate within this industry. Am. J. Ind. Med. 56:1463-1472, 2013. © 2013 Wiley Periodicals, Inc. © 2013 Wiley Periodicals, Inc.

Using resources for scientific-driven pharmacovigilance: from many product safety documents to one product safety master file.

PubMed

Furlan, Giovanni

2012-08-01

Current regulations require a description of the overall safety profile or the specific risks of a drug in multiple documents such as the Periodic and Development Safety Update Reports, Risk Management Plans (RMPs) and Signal Detection Reports. In a resource-constrained world, the need for preparing multiple documents reporting the same information results in shifting the focus from a thorough scientific and medical evaluation of the available data to maintaining compliance with regulatory timelines. Since the aim of drug safety is to understand and characterize product issues to take adequate risk minimization measures rather than to comply with bureaucratic requirements, there is the need to avoid redundancy. In order to identify core drug safety activities that need to be undertaken to protect patient safety and reduce the number of documents reporting the results of these activities, the author has reviewed the main topics included in the drug safety guidelines and templates. The topics and sources that need to be taken into account in the main regulatory documents have been found to greatly overlap and, in the future, as a result of the new Periodic Safety Update Report structure and requirements, in the author's opinion this overlap is likely to further increase. Many of the identified inter-document differences seemed to be substantially formal. The Development Safety Update Report, for example, requires separate presentation of the safety issues emerging from different sources followed by an overall evaluation of each safety issue. The RMP, instead, requires a detailed description of the safety issues without separate presentation of the evidence derived from each source. To some extent, however, the individual documents require an in-depth analysis of different aspects; the RMP, for example, requires an epidemiological description of the indication for which the drug is used and its risks. At the time of writing this article, this is not specifically

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.

[The experience of involvement of volunteers into maintenance of infection safety during period of implementation of mass activities].

PubMed

Imamov, A A; Balabanova, L A; Zamalieva, M A

2016-01-01

The article presents experience of Rospotrebnadzor in the Republic of Tatarstan in the field of preventive medicine concerning training of volunteers on issues of infection safety with purpose of prevention of ictuses of infection diseases during mass activities with international participation in the period of XXVII World Summer Students Games. The model of hygienic training for volunteers provides two directions: training for volunteers ’ leaders on issues of infection safety and remote course for involved volunteers. During period of preparation for the Students Games-2013 hygienic training was organized for volunteers-leaders in the field of infection safety with following attestation. The modern training technologies were applied. The volunteers-leaders familiarized with groups of infection diseases including the most dangerous ones, investigated with expert algorithm of actions to be applied in case of suspicion on infection disease in gest or participant of the Games-2013 to secure one's health and health of immediate population. The active volunteers-leaders became trainers and coaches in the field of infection safety. The second stage of infection safety training organized by youth trainers' pool in number of 30 individuals the training technology "Equal trains equal" was applied for hygienic training of volunteers involved at epidemiologically significant objects (food objects, hotels, accompaniment of guests and sportsmen). The volunteers-leaders trained to infection safety 1400 volunteers. The format of electronic personal cabinet and remote course were selected as tools of post-training monitoring.

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.

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.

Safety of vaccinations in patients with cryopyrin-associated periodic syndromes: a prospective registry based study.

PubMed

Jaeger, Veronika K; Hoffman, Hal M; van der Poll, Tom; Tilson, Hugh; Seibert, Julia; Speziale, Antonio; Junge, Guido; Franke, Kristina; Vritzali, Eleni; Hawkins, Philip N; Kuemmerle-Deschner, Jasmin; Walker, Ulrich A

2017-09-01

Pneumococcal, tetanus and influenza vaccinations are recommended for patients with cryopyrin-associated periodic syndromes (CAPS) when treated with immunosuppressive medication. The aim of this publication is to report the safety of pneumococcal and other vaccinations in CAPS patients. All CAPS patients followed in the β-CONFIDENT (Clinical Outcomes and Safety Registry study of Ilaris patients) registry were analysed if they had received a vaccination. The β-CONFIDENT registry is a global, long-term, prospective, observational registry, capturing and monitoring patients treated with canakinumab. Sixty-eight CAPS patients had received a total of 159 vaccine injections, 107 injections against influenza, 19 pneumococcal vaccinations, 12 against tetanus/diphtheria antigens and 21 other vaccinations. Fourteen per cent of injections had elicited at least one vaccine reaction. All five vaccine-related serious adverse events were associated with pneumococcal vaccination. Vaccine reactions were observed in 70% of pneumococcal vaccinations, compared with 7% in influenza and 17% in tetanus/diphtheria vaccinations. The odds ratios to react to the pneumococcal vaccines compared with influenza and tetanus/diphtheria vaccines were 31.0 (95% CI: 8, 119) and 10.8 (95% CI: 2, 74). Vaccine reactions after pneumococcal vaccinations were more severe and lasted significantly longer (up to 3 weeks) compared with other vaccinations. In two patients, pneumococcal vaccination also elicited symptoms consistent with systemic inflammation due to CAPS reactivation. Pneumococcal vaccines, unlike other vaccines, frequently trigger severe local and systemic inflammation in CAPS patients. Clinicians must balance potential benefits of pneumococcal immunization against safety concerns. The 13-valent pneumococcal conjugate vaccine might be favourable over the polysaccharide vaccine in CAPS patients. © The Author 2017. Published by Oxford University Press on behalf of the British Society for

20 CFR 416.728 - Penalty period: Second failure to report.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false Penalty period: Second failure to report. 416.728 Section 416.728 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Reports Required Penalty Deductions § 416.728 Penalty period: Second...

20 CFR 416.726 - Penalty period: First failure to report.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 20 Employees' Benefits 2 2013-04-01 2013-04-01 false Penalty period: First failure to report. 416.726 Section 416.726 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Reports Required Penalty Deductions § 416.726 Penalty period: First...

20 CFR 416.726 - Penalty period: First failure to report.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false Penalty period: First failure to report. 416.726 Section 416.726 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Reports Required Penalty Deductions § 416.726 Penalty period: First...

20 CFR 416.728 - Penalty period: Second failure to report.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 20 Employees' Benefits 2 2013-04-01 2013-04-01 false Penalty period: Second failure to report. 416.728 Section 416.728 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Reports Required Penalty Deductions § 416.728 Penalty period: Second...

Safety climate and attitude toward medication error reporting after hospital accreditation in South Korea.

PubMed

Lee, Eunjoo

2016-09-01

This study compared registered nurses' perceptions of safety climate and attitude toward medication error reporting before and after completing a hospital accreditation program. Medication errors are the most prevalent adverse events threatening patient safety; reducing underreporting of medication errors significantly improves patient safety. Safety climate in hospitals may affect medication error reporting. This study employed a longitudinal, descriptive design. Data were collected using questionnaires. A tertiary acute hospital in South Korea undergoing a hospital accreditation program. Nurses, pre- and post-accreditation (217 and 373); response rate: 58% and 87%, respectively. Hospital accreditation program. Perceived safety climate and attitude toward medication error reporting. The level of safety climate and attitude toward medication error reporting increased significantly following accreditation; however, measures of institutional leadership and management did not improve significantly. Participants' perception of safety climate was positively correlated with their attitude toward medication error reporting; this correlation strengthened following completion of the program. Improving hospitals' safety climate increased nurses' medication error reporting; interventions that help hospital administration and managers to provide more supportive leadership may facilitate safety climate improvement. Hospitals and their units should develop more friendly and intimate working environments that remove nurses' fear of penalties. Administration and managers should support nurses who report their own errors. © The Author 2016. 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.

20 CFR 416.728 - Penalty period: Second failure to report.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Penalty period: Second failure to report. 416.728 Section 416.728 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME... penalty period. The due date and the failure to report on time are the important factors in establishing a...

Bus safety study : a report to Congress.

DOT National Transportation Integrated Search

2013-11-01

Section 20021(b) of the Moving Ahead for Progress for the 21st Century (MAP-21) legislation requires the Secretary of Transportation : to submit a report of the results of a Bus Safety Study to the Committee on Banking, Housing, and Urban Affai...

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

18 CFR 12.10 - Reporting safety-related incidents.

Code of Federal Regulations, 2010 CFR

2010-04-01

... report of any death or serious injury considered or alleged to be project related must also describe any... be verified in accordance with § 12.13. (3) Accidents that are not project-related may be reported by... COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT SAFETY OF WATER POWER PROJECTS AND...

18 CFR 290.103 - Time of filing and reporting period.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Time of filing and reporting period. 290.103 Section 290.103 Conservation of Power and Water Resources FEDERAL ENERGY... POLICIES ACT OF 1978 Coverage, Compliance and Definitions § 290.103 Time of filing and reporting period...

18 CFR 290.103 - Time of filing and reporting period.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Time of filing and reporting period. 290.103 Section 290.103 Conservation of Power and Water Resources FEDERAL ENERGY... POLICIES ACT OF 1978 Coverage, Compliance and Definitions § 290.103 Time of filing and reporting period...

Comparison of food safety cognitions and self-reported food-handling behaviors with observed food safety behaviors of young adults.

PubMed

Abbot, J M; Byrd-Bredbenner, C; Schaffner, D; Bruhn, C M; Blalock, L

2009-04-01

Developing tailored and effective food safety education for young adults is critical given their future roles as caregivers likely to be preparing food for populations who may be at greater risk for foodborne disease (FBD). The objective of this study was to examine the relationship between food safety self-reported food-handling behaviors and cognitions of young adults to observed food-handling behaviors. Participants were 153 young adults (mean age 20.74+/-1.30 s.d.) attending a major American university. Each prepared a meal under observation in a controlled laboratory setting, permitted researchers to observe their home kitchen and completed an online survey assessing food safety knowledge, behavior and psychosocial measures. Descriptive statistics were generated for participants' self-reported food-handling behaviors, psychosocial characteristics, knowledge, food preparation observations and home kitchen observations. Determinants of compliance with safe food-handling procedures while preparing a meal and home food storage/rotation practices were identified using backward regression models. Participants engaged in less than half of the recommended safe food-handling practices evaluated and correctly answered only two-thirds of the food safety knowledge items. They reported positive food safety beliefs and high food safety self-efficacy. Self-reported compliance with cross-contamination prevention, disinfection procedures and knowledge of groups at greatest risk for FBD were the best measures for predicting compliance with established safe food-handling practices. Food safety education directed toward young adults should focus on increasing awareness of FBD and knowledge of proper cross-contamination prevention procedures to help promote better compliance with actual safe food handling.

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.

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.

Lessons learnt from Dental Patient Safety Case Reports

PubMed Central

Obadan, Enihomo M.; Ramoni, Rachel B.; Kalenderian, Elsbeth

2015-01-01

Background Errors are commonplace in dentistry, it is therefore our imperative as dental professionals to intercept them before they lead to an adverse event, and/or mitigate their effects when an adverse event occurs. This requires a systematic approach at both the profession-level, encapsulated in the Agency for Healthcare Research and Quality’s Patient Safety Initiative structure, as well as at the practice-level, where Crew Resource Management is a tested paradigm. Supporting patient safety at both the dental practice and profession levels relies on understanding the types and causes of errors, an area in which little is known. Methods A retrospective review of dental adverse events reported in the literature was performed. Electronic bibliographic databases were searched and data were extracted on background characteristics, incident description, case characteristics, clinic setting where adverse event originated, phase of patient care that adverse event was detected, proximal cause, type of patient harm, degree of harm and recovery actions. Results 182 publications (containing 270 cases) were identified through our search. Delayed and unnecessary treatment/disease progression after misdiagnosis was the largest type of harm reported. 24.4% of reviewed cases were reported to have experienced permanent harm. One of every ten case reports reviewed (11.1%) reported that the adverse event resulted in the death of the affected patient. Conclusions Published case reports provide a window into understanding the nature and extent of dental adverse events, but for as much as the findings revealed about adverse events, they also identified the need for more broad-based contributions to our collective body of knowledge about adverse events in the dental office and their causes. Practical Implications Siloed and incomplete contributions to our understanding of adverse events in the dental office are threats to dental patients’ safety. PMID:25925524

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.

21 CFR 312.32 - IND safety reports.

Code of Federal Regulations, 2010 CFR

2010-04-01

... safety reports. (a) Definitions. The following definitions of terms apply to this section:- Associated... intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include... example, under this definition, hepatic necrosis would be unexpected (by virtue of greater severity) if...

Aerospace Safety Advisory Panel Annual Report for 1999

NASA Technical Reports Server (NTRS)

Blomberg, Richard D.

2000-01-01

This report covers the activities of the Aerospace Safety Advisory Panel (ASAP) for the calendar year 1999.This was a year of notable achievements and significant frustrations. Both the Space Shuttle and International Space Station (ISS) programs were delayed.The Space Shuttle prudently postponed launches after the occurrence of a wiring short during ascent of the STS-93 mission. The ISS construction schedule slipped as a result of the Space Shuttle delays and problems the Russians experienced in readying the Service Module and its launch vehicle. Each of these setbacks was dealt with in a constructive way. The STS-93 short circuit led to detailed wiring inspections and repairs on all four orbiters as well as analysis of other key subsystems for similar types of hidden damage. The ISS launch delays afforded time for further testing, training, development, and contingency planning. The safety consciousness of the NASA and contractor workforces, from hands-on labor to top management, continues high. Nevertheless, workforce issues remain among the most serious safety concerns of the Panel. Cutbacks and reorganizations over the past several years have resulted in problems related to workforce size, critical skills, and the extent of on-the-job experience. These problems have the potential to impact safety as the Space Shuttle launch rate increases to meet the demands of the ISS and its other customers. As with last year's report, these work- force-related issues were considered of sufficient import to place them first in the material that follows. Some of the same issues of concern for the Space Shuttle and ISS arose in a review of the launch vehicle for the Terra mission that the Panel was asked by NASA to undertake. Other areas the Panel was requested to assess included the readiness of the Inertial Upper Stage for the deployment of the Chandra X-ray Observatory and the possible safety impact of electromagnetic effects on the Space Shuttle. The findings and

FAA National Aviation Safety Inspection Program. Annual Report FY90

DOT National Transportation Integrated Search

1991-06-01

This report was undertaken to document, analyze, and place : into national perspective the findings from the 1990 National : Aviation Safety Inspection Program (NASIP). This report is the : fifth in a series of annual reports covering the results of ...

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

75 FR 36615 - Pipeline Safety: Information Collection Gas Distribution Annual Report Form

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-28

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part 192 [Docket No. PHMSA-RSPA-2004-19854] Pipeline Safety: Information Collection Gas Distribution Annual Report Form AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Request...

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

21 CFR 601.93 - Postmarketing safety reporting.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Postmarketing safety reporting. 601.93 Section 601.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible...

21 CFR 314.630 - Postmarketing safety reporting.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 314.630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.630 Postmarketing safety reporting. Drug...

21 CFR 601.93 - Postmarketing safety reporting.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Postmarketing safety reporting. 601.93 Section 601.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible...

21 CFR 314.630 - Postmarketing safety reporting.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 314.630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.630 Postmarketing safety reporting. Drug...

21 CFR 601.93 - Postmarketing safety reporting.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Postmarketing safety reporting. 601.93 Section 601.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible...

21 CFR 314.630 - Postmarketing safety reporting.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 314.630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.630 Postmarketing safety reporting. Drug...

21 CFR 314.630 - Postmarketing safety reporting.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 314.630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.630 Postmarketing safety reporting. Drug...

21 CFR 314.630 - Postmarketing safety reporting.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 314.630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.630 Postmarketing safety reporting. Drug...

21 CFR 601.93 - Postmarketing safety reporting.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Postmarketing safety reporting. 601.93 Section 601.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible...

21 CFR 601.93 - Postmarketing safety reporting.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Postmarketing safety reporting. 601.93 Section 601.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible...

Safety Management Information Statistics (SAMIS) - 1993 Annual Report

DOT National Transportation Integrated Search

1995-05-01

The 1993 Safety Management Information Statistics (SAMIS) report, now in its fourth year of publication, is a compilation and analysis of transit accident and casualty statistics uniformly collected from approximately 400 transit agencies throughout ...

Independent evaluation of the transit retrofit package safety applications : final report.

DOT National Transportation Integrated Search

2015-02-01

This report presents the methodology and results of the independent evaluation of retrofit safety packages installed on transit vehicles in the : Safety Pilot Model Deploymentpart of the United States Department of Transportations Intelligent T...

78 FR 14188 - Safety Zone, Change to Enforcement Period, Patapsco River, Northwest and Inner Harbors; Baltimore...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-05

... enforcement period of a safety zone regulation for the annual movement of the historic sloop-of-war USS... sloop-of-war USS CONSTELLATION in Baltimore, Maryland on the Thursday before Memorial Day (observed... McHenry National Monument and Historic Site. Beginning at 3 p.m., the historic Sloop-of-War USS...

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

PubMed

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

2018-04-27

The aims of the study were to evaluate the amount and content of data patients and care partners reported using a real-time electronic safety tool compared with other reporting mechanisms and to understand their perspectives on safety concerns and reporting in the hospital. This study used mixed methods including 20-month preimplementation and postimplementation trial evaluating MySafeCare, a web-based application, which allows hospitalized patients/care partners to report safety concerns in real time. The study compared MySafeCare submission rates for three hospital units (oncology acute care, vascular intermediate care, medical intensive care) with submissions rates of Patient Family Relations (PFR) Department, a hospital service to address patient/family concerns. The study used triangulation of quantitative data with thematic analysis of safety concern submissions and patient/care partner interviews to understand submission content and perspectives on safety reporting. Thirty-two MySafeCare submissions were received with an average rate of 1.7 submissions per 1000 patient-days and a range of 0.3 to 4.8 submissions per 1000 patient-days across all units, indicating notable variation between units. MySafeCare submission rates were significantly higher than PFR submission rates during the postintervention period on the vascular unit (4.3 [95% confidence interval = 2.8-6.5] versus 1.5 [95% confidence interval = 0.7-3.1], Poisson) (P = 0.01). Overall trends indicated a decrease in PFR submissions after MySafeCare implementation. Triangulated data indicated patients preferred to report anonymously and did not want concerns submitted directly to their care team. MySafeCare evaluation confirmed the potential value of providing an electronic, anonymous reporting tool in the hospital to capture safety concerns in real time. Such applications should be tested further as part of patient safety programs.This is an open-access article distributed under the terms of the

Patient-reported safety incidents in older patients with long-term conditions: a large cross-sectional study

PubMed Central

Panagioti, Maria; Blakeman, Thomas; Hann, Mark; Bower, Peter

2017-01-01

Background Increasing evidence suggests that patient safety is a serious concern for older patients with long-term conditions. Despite this, there is a lack of research on safety incidents encountered by this patient group. In this study, we sought to examine patient reports of safety incidents and factors associated with reports of safety incidents in older patients with long-term conditions. Methods The baseline cross-sectional data from a longitudinal cohort study were analysed. Older patients (n=3378 aged 65 years and over) with a long-term condition registered in general practices were included in the study. The main outcome was patient-reported safety incidents including availability and appropriateness of medical tests and prescription of wrong types or doses of medication. Binary univariate and multivariate logistic regression analyses were undertaken to examine factors associated with patient-reported safety incidents. Results Safety incidents were reported by 11% of the patients. Four factors were significantly associated with patient-reported safety incidents in multivariate analyses. The experience of multiple long-term conditions (OR=1.09, 95% CI 1.05 to 1.13), a probable diagnosis of depression (OR=1.36, 95% CI 1.06 to 1.74) and greater relational continuity of care (OR=1.28, 95% CI 1.08 to 1.52) were associated with increased odds for patient-reported safety incidents. Perceived greater support and involvement in self-management was associated with lower odds for patient-reported safety incidents (OR=0.95, 95% CI 0.93 to 0.97). Conclusions We found that older patients with multimorbidity and depression are more likely to report experiences of patient safety incidents. Improving perceived support and involvement of patients in their care may help prevent patient-reported safety incidents. PMID:28559454

Parents' Self-Reported Behaviors Related to Health and Safety of Very Young Children.

ERIC Educational Resources Information Center

Hendricks, Charlotte M.; Reichert, Ann

1996-01-01

Reports a survey that documented the health and safety behaviors of parents of children in Head Start programs. Nearly all parents reported using car seats, teaching handwashing and pedestrian safety, and locking away medicine and alcohol. Sixty percent reported storing guns and bullets safely, possessing working fire extinguishers, and having…

State Safety Oversight Program : annual report for 2003

DOT National Transportation Integrated Search

2004-10-01

The Federal Transit Administration (FTA) State Safety Oversight Rule (49 CFR Part 659) requires oversight of all rail transit agencies in revenue operation after January 1, 1997. This report summarizes activities performed to implement the State Safe...

State safety oversight program : annual report for 1999

DOT National Transportation Integrated Search

2000-09-01

The Federal Transit Administration (FTA) State Safety Oversight Rule (49 CFR Part 659) requires oversight for all rail transit agencies in revenue operation after January 1, 1997. This report summarizes activities performed to implement the State Saf...

Transit safety & security statistics & analysis 2003 annual report (formerly SAMIS)

DOT National Transportation Integrated Search

2005-12-01

The Transit Safety & Security Statistics & Analysis 2003 Annual Report (formerly SAMIS) is a compilation and analysis of mass transit accident, casualty, and crime statistics reported under the Federal Transit Administrations (FTAs) National Tr...

Transit safety & security statistics & analysis 2002 annual report (formerly SAMIS)

DOT National Transportation Integrated Search

2004-12-01

The Transit Safety & Security Statistics & Analysis 2002 Annual Report (formerly SAMIS) is a compilation and analysis of mass transit accident, casualty, and crime statistics reported under the Federal Transit Administrations (FTAs) National Tr...

Dietary Supplement Adverse Event Report Data From the FDA Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS), 2004-2013.

PubMed

Timbo, Babgaleh B; Chirtel, Stuart J; Ihrie, John; Oladipo, Taiye; Velez-Suarez, Loy; Brewer, Vickery; Mozersky, Robert

2018-05-01

The Food and Drug Administration (FDA)'s Center for Food Safety and Applied Nutrition (CFSAN) oversees the safety of the nation's foods, dietary supplements, and cosmetic products. To present a descriptive analysis of the 2004-2013 dietary supplement adverse event report (AER) data from CAERS and evaluate the 2006 Dietary Supplements and Nonprescription Drug Consumer Protection Act as pertaining to dietary supplements adverse events reporting. We queried CAERS for data from the 2004-2013 AERs specifying at least 1 suspected dietary supplement product. We extracted the product name(s), the symptom(s) reported, age, sex, and serious adverse event outcomes. We examined time trends for mandatory and voluntary reporting and performed analysis using SAS v9.4 and R v3.3.0 software. Of the total AERs (n = 15 430) received from January 1, 2004, through December 31, 2013, indicating at least 1 suspected dietary supplement product, 66.9% were mandatory, 32.2% were voluntary, and 0.9% were both mandatory and voluntary. Reported serious outcomes included death, life-threatening conditions, hospitalizations, congenital anomalies/birth defects and events requiring interventions to prevent permanent impairments (5.1%). The dietary supplement adverse event reporting rate in the United States was estimated at ~2% based on CAERS data. This study characterizes CAERS dietary supplement adverse event data for the 2004-2013 period and estimates a reporting rate of 2% for dietary supplement adverse events based on CAERS data. The findings show that the 2006 Dietary Supplements and Nonprescription Drug Consumer Protection Act had a substantial impact on the reporting of adverse events.

Training Course for Compliance Safety and Health Officers. Final Report.

ERIC Educational Resources Information Center

McKnight, A. James; And Others

The report describes revision of the Compliance Safety and Health Officers (CSHO) course for the Department of Labor, Occupational Safety and Health Administration (OSHA). The CSHO's job was analyzed in depth, in accord with OSHA standards, policies, and procedures. A listing of over 1,700 violations of OSHA standards was prepared, and specialists…

Predictors of Hospital Nurses' Safety Practices: Work Environment, Workload, Job Satisfaction, and Error Reporting.

PubMed

Chiang, Hui-Ying; Hsiao, Ya-Chu; Lee, Huan-Fang

Nurses' safety practices of medication administration, prevention of falls and unplanned extubations, and handover are essentials to patient safety. This study explored the prediction between such safety practices and work environment factors, workload, job satisfaction, and error-reporting culture of 1429 Taiwanese nurses. Nurses' job satisfaction, error-reporting culture, and one environmental factor of nursing quality were found to be major predictors of safety practices. The other environment factors related to professional development and participation in hospital affairs and nurses' workload had limited predictive effects on the safety practices. Increasing nurses' attention to patient safety by improving these predictors is recommended.

Vision and commercial motor vehicle driver safety : vol. 1 : evidence report

DOT National Transportation Integrated Search

2008-06-06

The purpose of this evidence report is to address several key questions posed by the Federal Motor Carrier Safety Administration (FMCSA) that pertain to vision and commercial motor vehicle (CMV) driver safety. Each of these key questions was develope...

40 CFR 63.130 - Transfer operations provisions-periodic recordkeeping and reporting.

Code of Federal Regulations, 2012 CFR

2012-07-01

...-periodic recordkeeping and reporting. 63.130 Section 63.130 Protection of Environment ENVIRONMENTAL..., and Wastewater § 63.130 Transfer operations provisions—periodic recordkeeping and reporting. (a) Each... monitored under § 63.127 of this subpart, and listed in table 7 of this subpart or specified by the...

40 CFR 63.130 - Transfer operations provisions-periodic recordkeeping and reporting.

Code of Federal Regulations, 2013 CFR

2013-07-01

...-periodic recordkeeping and reporting. 63.130 Section 63.130 Protection of Environment ENVIRONMENTAL..., and Wastewater § 63.130 Transfer operations provisions—periodic recordkeeping and reporting. (a) Each... monitored under § 63.127 of this subpart, and listed in table 7 of this subpart or specified by the...

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.

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).

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

Meeting Report: 2013 PDA Virus & TSE Safety Forum.

PubMed

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

2014-01-01

The report provides a summary of the presentations and discussions at the Virus & TSE Safety Forum 2013 organized by the Parenteral Drug Association (PDA) and held in Berlin, Germany, from June 4 to 6, 2013. The conference was accompanied by a workshop, "Virus Spike Preparations and Virus Removal by Filtration: New Trends and Developments". The presentations and the discussion at the workshop are summarized in a separate report that will be published in this issue of the journal as well. As with previous conferences of this series, the PDA Virus & TSE Safety Forum 2013 provided again an excellent opportunity to exchange information and opinions between the industry, research organizations, and regulatory bodies. Updates on regulatory considerations related to virus and transmissible spongiform encephalopathy (TSE) safety of biopharmaceuticals were provided by agencies of the European Union (EU), the United States (US), and Singapore. The epidemiology and detection methods of new emerging pathogens like hepatitis E virus and parvovirus (PARV 4) were exemplified, and the risk of contamination of animal-derived raw materials like trypsin was considered in particular. The benefit of using new sequence-based virus detection methods was discussed. Events of bioreactor contaminations in the past drew the attention to root cause investigations and preventive actions, which were illustrated by several examples. Virus clearance data of specific unit operations were provided; the discussion focused on the mechanism of virus clearance and on the strategic concept of viral clearance integration. As in previous years, the virus safety section was followed by a TSE section that covered recent scientific findings that may influence the risk assessment of blood and cell substrates. These included the realization that interspecies transmission of TSE by blood components in sheep is greater than predicted by assays in transgenic mice. Also, the pathogenesis and possibility of

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 ...

Zero Tolerance: A Stage Adaptation of an Investigative Report on School Safety

ERIC Educational Resources Information Center

Goldstein, Tara; Wickett, Jocelyn

2009-01-01

In May 2007, 15-year-old Jordan Manners was shot and killed in the hallway of his Toronto school. In June 2007, the Toronto District School Board commissioned an investigation into school safety, which resulted in a report entitled "The Road to Health: A Final Report on School Safety." In February 2008, in an attempt to provoke…

The accuracy of pain and fatigue items across different reporting periods

PubMed Central

Broderick, Joan E.; Schwartz, Joseph E.; Vikingstad, Gregory; Pribbernow, Michelle; Grossman, Steven; Stone, Arthur A.

2008-01-01

The length of the reporting period specified for items assessing pain and fatigue varies among instruments. How the length of recall impacts the accuracy of symptom reporting is largely unknown. This study investigated the accuracy of ratings for reporting periods ranging from 1 day to 28 days for several items from widely used pain and fatigue measures (SF36v2, Brief Pain Inventory, McGill Pain Questionnaire, Brief Fatigue Inventory). Patients from a community rheumatology practice (N=83) completed momentary pain and fatigue items on average 5.4 times per day for a month using an electronic diary. Averaged momentary ratings formed the basis for comparison with recall ratings interspersed throughout the month referencing 1-day, 3-day, 7-day, and 28-day periods. As found in previous research, recall ratings were consistently inflated relative to averaged momentary ratings. Across most items, 1-day recall corresponded well to the averaged momentary assessments for the day. Several, but not all, items demonstrated substantial correlations across the different reporting periods. An additional 7 day-by-day recall task suggested that patients have increasing difficulty actually remembering symptom levels beyond the past several days. These data were collected while patients were receiving usual care and may not generalize to conditions where new interventions are being introduced and outcomes evaluated. Reporting periods can influence the accuracy of retrospective symptom reports and should be a consideration in study design. PMID:18455312

2007 motor vehicle occupant safety survey. Volume 4, Crash injury and emergency medical services report

DOT National Transportation Integrated Search

2008-12-01

The 2007 Motor Vehicle Occupant Safety Survey was the sixth in a series of periodic national telephone surveys on occupant protection issues conducted for the National Highway Traffic Safety Administration (NHTSA). Data collection was conducted by Sc...

[The effectiveness of error reporting promoting strategy on nurse's attitude, patient safety culture, intention to report and reporting rate].

PubMed

Kim, Myoungsoo

2010-04-01

The purpose of this study was to examine the impact of strategies to promote reporting of errors on nurses' attitude to reporting errors, organizational culture related to patient safety, intention to report and reporting rate in hospital nurses. A nonequivalent control group non-synchronized design was used for this study. The program was developed and then administered to the experimental group for 12 weeks. Data were analyzed using descriptive analysis, X(2)-test, t-test, and ANCOVA with the SPSS 12.0 program. After the intervention, the experimental group showed significantly higher scores for nurses' attitude to reporting errors (experimental: 20.73 vs control: 20.52, F=5.483, p=.021) and reporting rate (experimental: 3.40 vs control: 1.33, F=1998.083, p<.001). There was no significant difference in some categories for organizational culture and intention to report. The study findings indicate that strategies that promote reporting of errors play an important role in producing positive attitudes to reporting errors and improving behavior of reporting. Further advanced strategies for reporting errors that can lead to improved patient safety should be developed and applied in a broad range of hospitals.

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

Practice-specific risk perceptions and self-reported food safety practices.

PubMed

Levy, Alan S; Choinière, Conrad J; Fein, Sara B

2008-06-01

The relationship between risk perception and risk avoidance is typically analyzed using self-reported measures. However, in domains such as driving or food handling, the validity of responses about usual behavior is threatened because people think about the situations in which they are self-aware, such as when they encounter a hazard. Indeed, researchers have often noted a divergence between what people say about their behavior and how they actually behave. Thus, in order to draw conclusions about risk perceptions and risk avoidance from survey data, it is important to identify particular cognitive elements, such as those measured by questions about risk and safety knowledge, risk perceptions, or information search behavior, which may be effective antecedents of self-reported safety behavior. It is also important to identify and correct for potential sources of bias that may exist in the data. The authors analyze the Food and Drug Administration's 1998 Food Safety Survey to determine whether there are consistent cognitive antecedents for three types of safe food practices: preparation, eating, and cooling of foods. An assessment of measurement biases shows that endogeneity of food choices affects reports of food preparation. In addition, response bias affects reports of cooling practices as evidenced by its relation to knowledge and information search, a pattern of cognitive effects unique to cooling practices. After correcting for these biases, results show that practice-specific risk perceptions are the primary cognitive antecedents of safe food behavior, which has implications for the design of effective education messages about food safety.

Exploring the Influence of Nurse Work Environment and Patient Safety Culture on Attitudes Toward Incident Reporting.

PubMed

Yoo, Moon Sook; Kim, Kyoung Ja

2017-09-01

The aim of this study was to explore the influence of nurse work environments and patient safety culture on attitudes toward incident reporting. Patient safety culture had been known as a factor of incident reporting by nurses. Positive work environment could be an important influencing factor for the safety behavior of nurses. A cross-sectional survey design was used. The structured questionnaire was administered to 191 nurses working at a tertiary university hospital in South Korea. Nurses' perception of work environment and patient safety culture were positively correlated with attitudes toward incident reporting. A regression model with clinical career, work area and nurse work environment, and patient safety culture against attitudes toward incident reporting was statistically significant. The model explained approximately 50.7% of attitudes toward incident reporting. Improving nurses' attitudes toward incident reporting can be achieved with a broad approach that includes improvements in work environment and patient safety culture.

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.

[Patient safety: a comparison between handwritten and computerized voluntary incident reporting].

PubMed

Capucho, Helaine Carneiro; Arnas, Emilly Rasquini; Cassiani, Silvia Helena De Bortoli

2013-03-01

This study's objective was to compare two types of voluntary incident reporting methods that affect patient safety, handwritten (HR) and computerized (CR), in relation to the number of reports, type of incident reported the individual submitting the report, and quality of reports. This was a descriptive, retrospective and cross-sectional study. CR were more frequent than HR (61.2% vs. 38.6%) among the 1,089 reports analyzed and were submitted every day of the month, while HR were submitted only on weekdays. The highest number of reports referred to medication, followed by problems related to medical-hospital material and the professional who most frequently submitted reports were nurses in both cases. Overall CR presented higher quality than HR (86.1% vs. 61.7%); 36.8% of HR were illegible, a problem that was eliminated in CR. Therefore, the use of computerized incident reporting in hospitals favors qualified voluntary reports, increasing patient safety.

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.

Barriers to Safety Event Reporting in an Academic Radiology Department: Authority Gradients and Other Human Factors.

PubMed

Siewert, Bettina; Swedeen, Suzanne; Brook, Olga R; Eisenberg, Ronald L; Hochman, Mary

2018-05-15

Purpose To investigate barriers to reporting safety concerns in an academic radiology department and to evaluate the role of human factors, including authority gradients, as potential barriers to safety concern reporting. Materials and Methods In this institutional review board-approved, HIPAA-compliant retrospective study, an online questionnaire link was emailed four times to all radiology department staff members (n = 648) at a tertiary care institution. Survey questions included frequency of speaking up about safety concerns, perceived barriers to speaking up, and the annual number of safety concerns that respondents were unsuccessful in reporting. Respondents' sex, role in the department, and length of employment were recorded. Statistical analysis was performed with the Fisher exact test. Results The survey was completed by 363 of the 648 employees (56%). Of those 363 employees, 182 (50%) reported always speaking up about safety concerns, 134 (37%) reported speaking up most of the time, 36 (10%) reported speaking up sometimes, seven (2%) reported rarely speaking up, and four (1%) reported never speaking up. Thus, 50% of employees spoke up about safety concerns less than 100% of the time. The most frequently reported barriers to speaking up included high reporting threshold (69%), reluctance to challenge someone in authority (67%), fear of disrespect (53%), and lack of listening (52%). Conclusion Of employees in a large academic radiology department, 50% do not attain 100% reporting of safety events. The most common human barriers to speaking up are high reporting threshold, reluctance to challenge authority, fear of disrespect, and lack of listening, which suggests that existing authority gradients interfere with full reporting of safety concerns. © RSNA, 2018.

Linguistic analysis of large-scale medical incident reports for patient safety.

PubMed

Fujita, Katsuhide; Akiyama, Masanori; Park, Keunsik; Yamaguchi, Etsuko Nakagami; Furukawa, Hiroyuki

2012-01-01

The analysis of medical incident reports is indispensable for patient safety. The cycles between analysis of incident reports and proposals to medical staffs are a key point for improving the patient safety in the hospital. Most incident reports are composed from freely written descriptions, but an analysis of such free descriptions is not sufficient in the medical field. In this study, we aim to accumulate and reinterpret findings using structured incident information, to clarify improvements that should be made to solve the root cause of the accident, and to ensure safe medical treatment through such improvements. We employ natural language processing (NLP) and network analysis to identify effective categories of medical incident reports. Network analysis can find various relationships that are not only direct but also indirect. In addition, we compare bottom-up results obtained by NLP with existing categories based on experts' judgment. By the bottom-up analysis, the class of patient managements regarding patients' fallings and medicines in top-down analysis is created clearly. Finally, we present new perspectives on ways of improving patient safety.

Cabin Safety Subject Index,

DTIC Science & Technology

1984-01-01

1949 CABIN SAFETY SUBJECT XNDEX(U) FEDERAL AVIATION /~D-AiS 4e9 ADMINISTRATION WASHINGTON DC OFFICE OF RYIRTION MEDICINE D N POLLARD ET AL. JAN 84...City, Oklahoma 73125 13. Type of Report and Period Covered 12. Sponsoring Agency Name and AddressOffice of Aviation Medicine & Office of Flight...Regulations numbers, Air Carrier Operations Bulletin numbers, Advisory Circular numbers, and Office of Aviation Medicine report numbers. U

49 CFR 585.88 - Petition to extend period to file report.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 7 2013-10-01 2013-10-01 false Petition to extend period to file report. 585.88... Electronic Stability Control System Phase-In Reporting Requirements § 585.88 Petition to extend period to... of the time stated in § 585.86(a). The filing of a petition does not automatically extend the time...

49 CFR 585.68 - Petition to extend period to file report.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 7 2013-10-01 2013-10-01 false Petition to extend period to file report. 585.68... Tire Pressure Monitoring System Phase-in Reporting Requirements § 585.68 Petition to extend period to... of the time stated in § 585.66(a). The filing of a petition does not automatically extend the time...

49 CFR 585.68 - Petition to extend period to file report.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 7 2010-10-01 2010-10-01 false Petition to extend period to file report. 585.68... Tire Pressure Monitoring System Phase-in Reporting Requirements § 585.68 Petition to extend period to... of the time stated in § 585.66(a). The filing of a petition does not automatically extend the time...

49 CFR 585.88 - Petition to extend period to file report.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 7 2011-10-01 2011-10-01 false Petition to extend period to file report. 585.88... Electronic Stability Control System Phase-In Reporting Requirements § 585.88 Petition to extend period to... of the time stated in § 585.86(a). The filing of a petition does not automatically extend the time...

49 CFR 585.88 - Petition to extend period to file report.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 7 2010-10-01 2010-10-01 false Petition to extend period to file report. 585.88... Electronic Stability Control System Phase-In Reporting Requirements § 585.88 Petition to extend period to... of the time stated in § 585.86(a). The filing of a petition does not automatically extend the time...

49 CFR 585.88 - Petition to extend period to file report.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 7 2014-10-01 2014-10-01 false Petition to extend period to file report. 585.88... Electronic Stability Control System Phase-In Reporting Requirements § 585.88 Petition to extend period to... of the time stated in § 585.86(a). The filing of a petition does not automatically extend the time...

49 CFR 585.88 - Petition to extend period to file report.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 7 2012-10-01 2012-10-01 false Petition to extend period to file report. 585.88... Electronic Stability Control System Phase-In Reporting Requirements § 585.88 Petition to extend period to... of the time stated in § 585.86(a). The filing of a petition does not automatically extend the time...

49 CFR 585.68 - Petition to extend period to file report.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 7 2014-10-01 2014-10-01 false Petition to extend period to file report. 585.68... Tire Pressure Monitoring System Phase-in Reporting Requirements § 585.68 Petition to extend period to... of the time stated in § 585.66(a). The filing of a petition does not automatically extend the time...

49 CFR 585.68 - Petition to extend period to file report.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 7 2011-10-01 2011-10-01 false Petition to extend period to file report. 585.68... Tire Pressure Monitoring System Phase-in Reporting Requirements § 585.68 Petition to extend period to... of the time stated in § 585.66(a). The filing of a petition does not automatically extend the time...

49 CFR 585.68 - Petition to extend period to file report.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 7 2012-10-01 2012-10-01 false Petition to extend period to file report. 585.68... Tire Pressure Monitoring System Phase-in Reporting Requirements § 585.68 Petition to extend period to... of the time stated in § 585.66(a). The filing of a petition does not automatically extend the time...

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.

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

PubMed

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

2015-02-01

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

49 CFR 545.9 - Petition to extend period to file report.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 6 2012-10-01 2012-10-01 false Petition to extend period to file report. 545.9... STANDARD PHASE-IN AND SMALL-VOLUME LINE REPORTING REQUIREMENTS § 545.9 Petition to extend period to file... of the time stated in § 545.5(a). The filing of a petition does not automatically extend the time for...

49 CFR 585.4 - Petitions to extend period to file report.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 7 2013-10-01 2013-10-01 false Petitions to extend period to file report. 585.4... General § 585.4 Petitions to extend period to file report. A petition for extension of the time to submit... Seventh Street, SW., Washington, DC 20590. The filing of a petition does not automatically extend the time...

49 CFR 585.4 - Petitions to extend period to file report.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 7 2011-10-01 2011-10-01 false Petitions to extend period to file report. 585.4... General § 585.4 Petitions to extend period to file report. A petition for extension of the time to submit... Seventh Street, SW., Washington, DC 20590. The filing of a petition does not automatically extend the time...

49 CFR 545.9 - Petition to extend period to file report.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 6 2010-10-01 2010-10-01 false Petition to extend period to file report. 545.9... STANDARD PHASE-IN AND SMALL-VOLUME LINE REPORTING REQUIREMENTS § 545.9 Petition to extend period to file... of the time stated in § 545.5(a). The filing of a petition does not automatically extend the time for...

49 CFR 545.9 - Petition to extend period to file report.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 6 2013-10-01 2013-10-01 false Petition to extend period to file report. 545.9... STANDARD PHASE-IN AND SMALL-VOLUME LINE REPORTING REQUIREMENTS § 545.9 Petition to extend period to file... of the time stated in § 545.5(a). The filing of a petition does not automatically extend the time for...

49 CFR 585.4 - Petitions to extend period to file report.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 7 2014-10-01 2014-10-01 false Petitions to extend period to file report. 585.4... General § 585.4 Petitions to extend period to file report. A petition for extension of the time to submit... Seventh Street, SW., Washington, DC 20590. The filing of a petition does not automatically extend the time...

49 CFR 545.9 - Petition to extend period to file report.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 6 2014-10-01 2014-10-01 false Petition to extend period to file report. 545.9... STANDARD PHASE-IN AND SMALL-VOLUME LINE REPORTING REQUIREMENTS § 545.9 Petition to extend period to file... of the time stated in § 545.5(a). The filing of a petition does not automatically extend the time for...

49 CFR 585.4 - Petitions to extend period to file report.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 7 2012-10-01 2012-10-01 false Petitions to extend period to file report. 585.4... General § 585.4 Petitions to extend period to file report. A petition for extension of the time to submit... Seventh Street, SW., Washington, DC 20590. The filing of a petition does not automatically extend the time...

49 CFR 585.4 - Petitions to extend period to file report.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 7 2010-10-01 2010-10-01 false Petitions to extend period to file report. 585.4... General § 585.4 Petitions to extend period to file report. A petition for extension of the time to submit... Seventh Street, SW., Washington, DC 20590. The filing of a petition does not automatically extend the time...

49 CFR 545.9 - Petition to extend period to file report.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 6 2011-10-01 2011-10-01 false Petition to extend period to file report. 545.9... STANDARD PHASE-IN AND SMALL-VOLUME LINE REPORTING REQUIREMENTS § 545.9 Petition to extend period to file... of the time stated in § 545.5(a). The filing of a petition does not automatically extend the time for...

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

DOT National Transportation Integrated Search

1998-08-01

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

Safety analysis report for packaging (onsite) multicanister overpack cask

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

Edwards, W.S.

1997-07-14

This safety analysis report for packaging (SARP) documents the safety of shipments of irradiated fuel elements in the MUlticanister Overpack (MCO) and MCO Cask for a highway route controlled quantity, Type B fissile package. This SARP evaluates the package during transfers of (1) water-filled MCOs from the K Basins to the Cold Vacuum Drying Facility (CVDF) and (2) sealed and cold vacuum dried MCOs from the CVDF in the 100 K Area to the Canister Storage Building in the 200 East Area.

10 CFR 72.70 - 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. 72.70 Section 72.70 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Records...

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).

77 FR 75439 - Guidances for Industry and Investigators on Safety Reporting Requirements for Investigational New...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-20

... Reporting Requirements for INDs and BA/BE Studies'' and ``Safety Reporting Requirements for INDs and BA/BE...) and bioavailability (BA) and bioequivalence (BE) studies. DATES: Submit either electronic or written... Reporting Requirements for INDs and BA/BE Studies'' and ``Safety Reporting Requirements for INDs and BA/BE...

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.

Long-term (5 years), high daily dosage of dietary agmatine--evidence of safety: a case report.

PubMed

Gilad, Gad M; Gilad, Varda H

2014-11-01

There is presently a great interest in the therapeutic potential of agmatine, decarboxylated arginine, for various diseases. Recent clinical studies have already shown that oral agmatine sulfate given for up to 3 weeks provides a safe and, as compared with current therapeutics, more effective treatment for neuropathic pain. These studies have ushered in the use of dietary agmatine as a nutraceutical. However, in view of information paucity, assessment of long-term safety of oral agmatine treatment is now clearly required. The authors of this report undertook to assess their own health status during ongoing consumption of a high daily dosage of oral agmatine over a period of 4-5 years. A daily dose of 2.67 g agmatine sulfate was encapsulated in gelatin capsules; the regimen consists of six capsules daily, each containing 445 mg, three in the morning and three in the evening after meals. Clinical follow-up consists of periodic physical examinations and laboratory blood and urine analyses. All measurements thus far remain within normal values and good general health status is sustained throughout the study period, up to 5 years. This case study shows for the first time that the recommended high dosage of agmatine may be consumed for at least 5 years without evidence of any adverse effects. These initial findings are highly important as they provide significant evidence for the extended long-term safety of a high daily dosage of dietary agmatine--a cardinal advantage for its utility as a nutraceutical.

Aerospace Safety Advisory Panel

NASA Technical Reports Server (NTRS)

2002-01-01

This Annual Report of the Aerospace Safety Advisory Panel (ASAP) presents results of activities during calendar year 2001. The year was marked by significant achievements in the Space Shuttle and International Space Station (ISS) programs and encouraging accomplishments by the Aerospace Technology Enterprise. Unfortunately, there were also disquieting mishaps with the X-43, a LearJet, and a wind tunnel. Each mishap was analyzed in an orderly process to ascertain causes and derive lessons learned. Both these accomplishments and the responses to the mishaps led the Panel to conclude that safety and risk management is currently being well served within NASA. NASA's operations evidence high levels of safety consciousness and sincere efforts to place safety foremost. Nevertheless, the Panel's safety concerns have never been greater. This dichotomy has arisen because the focus of most NASA programs has been directed toward program survival rather than effective life cycle planning. Last year's Annual Report focused on the need for NASA to adopt a realistically long planning horizon for the aging Space Shuttle so that safety would not erode. NASA's response to the report concurred with this finding. Nevertheless, there has been a greater emphasis on current operations to the apparent detriment of long-term planning. Budget cutbacks and shifts in priorities have severely limited the resources available to the Space Shuttle and ISS for application to risk-reduction and life-extension efforts. As a result, funds originally intended for long-term safety-related activities have been used for operations. Thus, while safety continues to be well served at present, the basis for future safety has eroded. Section II of this report develops this theme in more detail and presents several important, overarching findings and recommendations that apply to many if not all of NASA's programs. Section III of the report presents other significant findings, recommendations and supporting

The Washington State Task Force on Student Transportation Safety. Final Report.

ERIC Educational Resources Information Center

Washington State Legislature, Olympia.

Findings of a study conducted by the Washington State Task Force on Student Transportation Safety are presented in this report. The data-collection process involved four phases: meetings with experts in student transportation and pedestrian safety; public meetings, informational work sessions, and tours of problems areas; task force meetings; and…

Efficacy and safety of luseogliflozin added to insulin therapy in Japanese patients with type 2 diabetes: a multicenter, 52-week, clinical study with a 16-week, double-blind period and a 36-week, open-label period.

PubMed

Seino, Yutaka; Sasaki, Takashi; Fukatsu, Atsushi; Imazeki, Hisae; Ochiai, Hidekazu; Sakai, Soichi

2018-06-01

To evaluate the efficacy and safety of luseogliflozin in Japanese patients with type 2 diabetes (T2D) inadequately controlled with insulin monotherapy. This 52-week multicenter study entailed a 16-week, double-blind period followed by a 36-week, open-label period. Patients were randomized to receive either luseogliflozin 2.5 mg (n = 159) or placebo (n = 74) during the double-blind period. All patients who entered the open-label period received luseogliflozin. Major efficacy endpoints included the changes from baseline in HbA1c, fasting plasma glucose (FPG), postprandial plasma glucose (PPG) and bodyweight. Safety assessments included adverse events, laboratory tests and vital signs. In the double-blind period, luseogliflozin significantly decreased HbA1c (-1.18%), FPG (-42.4 mg/dL), 2 hour PPG (-68.7 mg/dL) and bodyweight (-1.27 kg) compared with placebo (all p < .001); these reductions were maintained over 52 weeks. The changes from baseline at Week 52 were -1.00%, -35.1 mg/dL, -68.8 mg/dL and -1.81 kg, respectively (all p < .001). In the placebo group, favorable glycemic control and bodyweight reduction were also observed after switching to luseogliflozin. Most adverse events were mild in severity. During the double-blind period, the incidences of hypoglycemia were 20.8% and 13.5% in the luseogliflozin and placebo groups, respectively. During the 52 weeks of luseogliflozin treatment, the frequency of hypoglycemia was 33.3%, but no serious hypoglycemia occurred. The safety profile other than hypoglycemia was also acceptable. There were no new safety concerns about luseogliflozin added to insulin. Luseogliflozin added to insulin therapy significantly improved glycemic control with bodyweight reduction and was well tolerated in Japanese patients with T2D. Japan Pharmaceutical Information Center (JapicCTI-142582).

77 FR 32146 - Safety Evaluation Report, International Isotopes Fluorine Products, Inc., Fluorine Extraction...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-31

... NUCLEAR REGULATORY COMMISSION [Docket No. 40-9086; NRC-2010-0143] Safety Evaluation Report... Deconversion Plant (FEP/DUP) and will be located in Lea County, New Mexico. The NRC has prepared a Safety..., Deconversion and Enrichment Branch, Division of Fuel Cycle Safety and Safeguards, Office of Nuclear Material...

Understanding safety climate in small automobile collision repair shops.

PubMed

Parker, David L; Brosseau, Lisa M; Bejan, Anca; Skan, Maryellen; Xi, Min

2014-01-01

In the United States, approximately 236,000 people work in 37,600 auto collision-repair businesses. Workers in the collision-repair industry may be exposed to a wide range of physical and chemical hazards. This manuscript examines the relationship of safety climate as reported by collision repair shop workers and owners to: (1) an independent business safety assessment, and (2) employee self-reported work practices. The study was conducted in the Twin Cities metropolitan area. A total of 199 workers from 49 collision shops completed a survey of self-reported work practices and safety climate. Surveys were completed by an owner or manager in all but three shops. In general, self-reported work practices were poor. Workers' scores on safety climate were uniformly lower than those of owners. For workers, there was no correlation between how well the business scored on an independent audit of business safety practices and the safety climate measures they reported. For owners, however, there was a positive correlation between safety climate scores and the business safety assessment. For workers, safety rules and procedures were associated with improved work practices for those engaged in both painting-related and body technician-related activities. The enforcement of safety rules and procedures emerged as a strong factor positively affecting self-reported work practices. These findings identify a simple, cost effective path to reducing hazards in small workplaces. © 2013 Wiley Periodicals, Inc.

Neonatal Safety Information Reported to the FDA During Drug Development Studies

PubMed Central

Avant, Debbie; Baer, Gerri; Moore, Jason; Zheng, Panli; Sorbello, Alfred; Ariagno, Ron; Yao, Lynne; Burckart, Gilbert J.; Wang, Jian

2017-01-01

Background Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates is complicated by the unique nature of the population and the level of illness. The objective of this study was to examine neonatal safety data submitted to the FDA in studies pursuant to the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) between 1998 and 2015. Methods FDA databases were searched for BPCA and/or PREA studies that enrolled neonates. Studies that enrolled a minimum of 3 neonates were analyzed for the presence and content of neonatal safety data. Results The analysis identified 40 drugs that were studied in 3 or more neonates. Of the 40 drugs, 36 drugs received a pediatric labeling change as a result of studies between 1998 and 2015, that included information from studies including neonates. Fourteen drugs were approved for use in neonates. Clinical trials for 20 of the drugs reported serious adverse events (SAEs) in neonates. The SAEs primarily involved cardiovascular events such as bradycardia and/or hypotension or laboratory abnormalities such as anemia, neutropenia, and electrolyte disturbances. Deaths were reported during studies of 9 drugs. Conclusions Our analysis revealed that SAEs were reported in studies involving 20 of the 40 drugs evaluated in neonates, with deaths identified in 9 of those studies. Patients enrolled in studies were often critically ill, which complicated determination of whether an adverse event was drug-related. We conclude that the traditional means for collecting safety information in drug development trials needs to be adjusted for neonates and will require the collaboration of regulators, industry, and the clinical and research communities to establish appropriate definitions and reporting strategies for the neonatal

Foodborne Outbreaks Reported to the U.S. Food Safety and Inspection Service, Fiscal Years 2007 through 2012.

PubMed

Robertson, Kis; Green, Alice; Allen, Latasha; Ihry, Timothy; White, Patricia; Chen, Wu-San; Douris, Aphrodite; Levine, Jeoffrey

2016-03-01

The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) works closely with federal, state, and local public health partners to investigate foodborne illness outbreaks associated with its regulated products. To provide insight into outbreaks associated with meat and poultry, outbreaks reported to FSIS during fiscal years 2007 through 2012 were evaluated. Outbreaks were classified according to the strength of evidence linking them to an FSIS-regulated product and by their epidemiological, etiological, and vehicle characteristics. Differences in outbreak characteristics between the period 2007 through 2009 and the period 2010 through 2012 were assessed using a chi-square test or Mann-Whitney U test. Of the 163 reported outbreaks eligible for analysis, 89 (55%) were identified as possibly linked to FSIS-regulated products and 74 (45%) were definitively linked to FSIS-regulated products. Overall, these outbreaks were associated with 4,132 illnesses, 772 hospitalizations, and 19 deaths. Shiga toxin-producing Escherichia coli was associated with the greatest proportion of reported outbreaks (55%), followed by Salmonella enterica (34%) and Listeria monocytogenes (7%). Meat and poultry products commercially sold as raw were linked to 125 (77%) outbreaks, and of these, 105 (80%) involved beef. Over the study period, the number of reported outbreaks definitively linked to FSIS-regulated products (P = 0.03) declined, while the proportion of culture-confirmed cases (P = 0.0001) increased. Our findings provide insight into the characteristics of outbreaks associated with meat and poultry products.

[Implementation of safety devices: biological accident prevention].

PubMed

Catalán Gómez, M Teresa; Sol Vidiella, Josep; Castellà Castellà, Manel; Castells Bo, Carolina; Losada Pla, Nuria; Espuny, Javier Lluís

2010-04-01

Accidental exposures to blood and biological material were the most frequent and potentially serious accidents in healthcare workers, reported in the Prevention of Occupational Risks Unit within 2002. Evaluate the biological percutaneous accidents decrease after a progressive introduction of safety devices. Biological accidents produced between 2.002 and 2.006 were analyzed and reported by the injured healthcare workers to the Level 2b Hospital Prevention of Occupational Risk Unit with 238 beds and 750 employees. The key of the study was the safety devices (peripheral i.v. catheter, needleless i.v. access device and capillary blood collection lancet). Within 2002, 54 percutaneous biological accidents were registered and 19 in 2006, that represents a 64.8% decreased. There has been no safety devices accident reported involving these material. Accidents registered during the implantation period occurred because safety devices were not used at that time. Safety devices have proven to be effective in reducing needle stick percutaneous accidents, so that they are a good choice in the primary prevention of biological accidents contact.

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.

20 CFR 416.730 - Penalty period: Three or more failures to report.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 20 Employees' Benefits 2 2013-04-01 2013-04-01 false Penalty period: Three or more failures to report. 416.730 Section 416.730 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Reports Required Penalty Deductions § 416.730 Penalty period...

20 CFR 416.730 - Penalty period: Three or more failures to report.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false Penalty period: Three or more failures to report. 416.730 Section 416.730 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Reports Required Penalty Deductions § 416.730 Penalty period...

75 FR 60129 - Draft Guidance for Industry and Investigators on Safety Reporting Requirements for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-29

... with the new requirements in the final rule entitled ``Investigational New Drug Safety Reporting...] Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational New... the agency considers your comment on this draft guidance before it begins work on the final version of...

Report to the Congress on depreciation recovery periods and methods

DOT National Transportation Integrated Search

2000-07-01

This report provides the results of Treasurys analysis of depreciation recovery periods : and methods under section 168. As discussed in this introduction and in more detail in the : report, an analysis of the current U.S. depreciation system invo...

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...

Writing Seveso II safety reports: new EU guidance reflecting 5 years' experience with the Directive.

PubMed

Wood, Maureen Heraty; Fabbri, Luciano; Struckl, Michael

2008-09-15

Since the coming into force of the Seveso II Directive, considerable experience has been acquired in regard to preparation of safety reports for establishments that fall under the requirements of this Directive. In light of this experience, the Amendment of the Seveso II Directive adopted by the European Parliament and the Council on 16 December 2003, gave the European Commission the mandate "to review by 31 December 2006 in close cooperation with the Member States, the existing Guidance on the Preparation of a safety report (EUR 17690)". As a result, a technical working group of Member States representing the Seveso competent authorities and the European Commission's Major Accident Hazards Bureau was established to review and re-examine the guidance. The new guidance maintains the high-level and overarching character of the older version, but improves the document through better definition of conceptual elements of the safety report and greater alignment with Annex II of the Directive, which describes the essential elements of the safety report. This paper describes the new guidance in terms of its contribution to developing a harmonized conceptual framework for preparing and reviewing safety reports within the context of Seveso II implementation. Overall, the aim of the guidance is to provide concrete advice to operators and competent authorities on the logic and expectations underlying the safety report, so as to make both preparation and review of the report a more efficient and useful exercise for all parties involved.

20 CFR 416.730 - Penalty period: Three or more failures to report.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Penalty period: Three or more failures to report. 416.730 Section 416.730 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY... period. The due date and the failure to report on time are the important factors in establishing a...

78 FR 34703 - Pipeline Safety: Information Collection Activities, Revision to Gas Distribution Annual Report

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-10

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2013-0004] Pipeline Safety: Information Collection Activities, Revision to Gas Distribution Annual Report AGENCY: Pipeline and Hazardous Materials Safety Administration, DOT. ACTION: Notice and request...

Safety training priorities

NASA Astrophysics Data System (ADS)

Thompson, N. A.; Ruck, H. W.

1984-04-01

The Air Force is interested in identifying potentially hazardous tasks and prevention of accidents. This effort proposes four methods for determining safety training priorities for job tasks in three enlisted specialties. These methods can be used to design training aimed at avoiding loss of people, time, materials, and money associated with on-the-job accidents. Job tasks performed by airmen were measured using task and job factor ratings. Combining accident reports and job inventories, subject-matter experts identified tasks associated with accidents over a 3-year period. Applying correlational, multiple regression, and cost-benefit analysis, four methods were developed for ordering hazardous tasks to determine safety training priorities.

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.

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

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.

77 FR 34457 - Pipeline Safety: Mechanical Fitting Failure Reports

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-11

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No... notice provides clarification to owners and operators of gas distribution pipeline facilities when... of a gas distribution pipeline facility to file a written report for any mechanical fitting failure...

Comprehensive School Safety Initiative Report

ERIC Educational Resources Information Center

National Institute of Justice, 2014

2014-01-01

The National Institute of Justice (NIJ) developed the Comprehensive School Safety Initiative in consultation with federal partners and Congress. It is a research-focused initiative designed to increase the safety of schools nationwide through the development of knowledge regarding the most effective and sustainable school safety interventions and…

75 FR 37310 - Health and Safety Data Reporting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-29

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 716 Health and Safety Data Reporting CFR Correction In Title 40 of the Code of Federal Regulations, Parts 700 to 789, revised as of July 1, 2009, make the following corrections: 1. At the bottom of page 86, in Sec. 716.20, paragraph (a) introductory text, in the...

LNG Safety Research: FEM3A Model Development

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

Iraj A. Salehi

This quarterly report for DE-FG26-04NT42030 covers a period from July 1, 2004 to September 30, 2004. Activity during this period included preparation of a CD containing the FEM3a FORTRAN code for distribution and organization of an LNG safety workshop. Contract negotiation between GTI and University of Arkansas continued.

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.

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.

Road safety in the Eastern Mediterranean Region--findings from the Global Road Safety Status Report.

PubMed

Soori, H; Hussain, S J; Razzak, J A

2011-10-01

A secondary data analysis using the Global Status Report on Road Safety (GSRRS) was carried out to assess the epidemiology of road traffic injuries (RTIs) and preventive strategies in the Eastern Mediterranean egion (EMR). EMR countries ranked equal first in the world for the highest number of fatalities due to RTIs (32.2 per 100 000 population). The region had about 4% of the world's vehicles with 0.097 registered vehicles per person. The number of injured cases in EMR was 210.1 per 100 000 population. Only 15% of EMR countries had a funded, independent, multisectoral body for road safety. Only 25% had mandatory seat-belt laws for both front-seat and rear-seat passengers, 60% had mandatory helmet laws for both drivers and passengers of motorized two-wheelers and 10% had child restraint laws. Road safety in EMR countries needs more attention and consideration.

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

24 CFR 1000.516 - What reporting period is covered by the annual performance report?

Code of Federal Regulations, 2013 CFR

2013-04-01

... HOUSING, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT NATIVE AMERICAN HOUSING ACTIVITIES Recipient Monitoring, Oversight and Accountability § 1000.516 What reporting period is covered by the annual...

24 CFR 1000.516 - What reporting period is covered by the annual performance report?

Code of Federal Regulations, 2014 CFR

2014-04-01

... HOUSING, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT NATIVE AMERICAN HOUSING ACTIVITIES Recipient Monitoring, Oversight and Accountability § 1000.516 What reporting period is covered by the annual...

24 CFR 1000.516 - What reporting period is covered by the annual performance report?

Code of Federal Regulations, 2012 CFR

2012-04-01

... HOUSING, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT NATIVE AMERICAN HOUSING ACTIVITIES Recipient Monitoring, Oversight and Accountability § 1000.516 What reporting period is covered by the annual...

24 CFR 1000.516 - What reporting period is covered by the annual performance report?

Code of Federal Regulations, 2011 CFR

2011-04-01

... HOUSING, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT NATIVE AMERICAN HOUSING ACTIVITIES Recipient Monitoring, Oversight and Accountability § 1000.516 What reporting period is covered by the annual...

24 CFR 1000.516 - What reporting period is covered by the annual performance report?

Code of Federal Regulations, 2010 CFR

2010-04-01

... HOUSING, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT NATIVE AMERICAN HOUSING ACTIVITIES Recipient Monitoring, Oversight and Accountability § 1000.516 What reporting period is covered by the annual...

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.

Effects of patient safety culture interventions on incident reporting in general practice: a cluster randomised trial

PubMed Central

Verbakel, Natasha J; Langelaan, Maaike; Verheij, Theo JM; Wagner, Cordula; Zwart, Dorien LM

2015-01-01

Background A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting A three-arm cluster randomised trial was conducted in a mixed method study, studying the effect of administering a patient safety culture questionnaire (intervention I), the questionnaire complemented with a practice-based workshop (intervention II) and no intervention (control) in 30 general practices in the Netherlands. Method The primary outcome, the number of reported incidents, was measured with a questionnaire at baseline and a year after. Analysis was performed using a negative binomial model. Secondary outcomes were quality and safety indicators and safety culture. Mixed effects linear regression was used to analyse the culture questionnaires. Results The number of incidents increased in both intervention groups, to 82 and 224 in intervention I and II respectively. Adjusted for baseline number of incidents, practice size and accreditation status, the study showed that practices that additionally participated in the workshop reported 42 (95% confidence interval [CI] = 9.81 to 177.50) times more incidents compared to the control group. Practices that only completed the questionnaire reported 5 (95% CI = 1.17 to 25.49) times more incidents. There were no statistically significant differences in staff perception of patient safety culture at follow-up between the three study groups. Conclusion Educating staff and facilitating discussion about patient safety culture in their own practice leads to increased reporting of incidents. It is beneficial to invest in a team-wise effort to improve patient safety. PMID:25918337

Effects of patient safety culture interventions on incident reporting in general practice: a cluster randomised trial.

PubMed

Verbakel, Natasha J; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M

2015-05-01

A constructive safety culture is essential for the successful implementation of patient safety improvements. To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. A three-arm cluster randomised trial was conducted in a mixed method study, studying the effect of administering a patient safety culture questionnaire (intervention I), the questionnaire complemented with a practice-based workshop (intervention II) and no intervention (control) in 30 general practices in the Netherlands. The primary outcome, the number of reported incidents, was measured with a questionnaire at baseline and a year after. Analysis was performed using a negative binomial model. Secondary outcomes were quality and safety indicators and safety culture. Mixed effects linear regression was used to analyse the culture questionnaires. The number of incidents increased in both intervention groups, to 82 and 224 in intervention I and II respectively. Adjusted for baseline number of incidents, practice size and accreditation status, the study showed that practices that additionally participated in the workshop reported 42 (95% confidence interval [CI] = 9.81 to 177.50) times more incidents compared to the control group. Practices that only completed the questionnaire reported 5 (95% CI = 1.17 to 25.49) times more incidents. There were no statistically significant differences in staff perception of patient safety culture at follow-up between the three study groups. Educating staff and facilitating discussion about patient safety culture in their own practice leads to increased reporting of incidents. It is beneficial to invest in a team-wise effort to improve patient safety. © British Journal of General Practice 2015.

78 FR 38803 - Pipeline Safety: Information Collection Activities, Revisions to Incident and Annual Reports for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-27

... Reports for Gas Pipeline Operators AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No... (OMB) Control No. 2137-0522, titled ``Incident and Annual Reports for Gas Pipeline Operators.'' PHMSA...

Use of portable ladders - field observations and self-reported safety performance in the cable TV industry.

PubMed

Chang, Wen-Ruey; Huang, Yueng-Hsiang; Brunette, Christopher; Lee, Jin

2017-11-01

Portable ladders incidents remain a major cause of falls from heights. This study reported field observations of environments, work conditions and safety behaviour involving portable ladders and their correlations with self-reported safety performance. Seventy-five professional installers of a company in the cable and other pay TV industry were observed for 320 ladder usages at their worksites. The participants also filled out a questionnaire to measure self-reported safety performance. Proper setup on slippery surfaces, correct method for ladder inclination setup and ladder secured at the bottom had the lowest compliance with best practices and training guidelines. The observation compliance score was found to have significant correlation with straight ladder inclined angle (Pearson's r = 0.23, p < 0.0002) and employees' self-reported safety participation (r = 0.29, p < 0.01). The results provide a broad perspective on employees' safety compliance and identify areas for improving safety behaviours. Practitioner Summary: A checklist was used while observing professional installers of a cable company for portable ladder usage at their worksites. Items that had the lowest compliance with best practices and training guidelines were identified. The results provide a broad perspective on employees' safety compliance and identify areas for improving safety behaviours.

Analytical Chemistry Division annual progress report for period ending November 30, 1977

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

Lyon, W.S.

1978-03-01

Activities for the year are summarized in sections on analytical methodology, mass and mass emission spectrometry, analytical services, bio-organic analysis, nuclear and radiochemical analysis, and quality assurance and safety. Presentations of research results in publications and reports are tabulated. (JRD)

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

76 FR 27271 - TSCA Inventory Update Reporting Modifications; Submission Period Suspension

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-11

... TSCA Inventory Update Reporting Modifications; Submission Period Suspension AGENCY: Environmental... proposed modifications to the IUR regulations. EPA is suspending the next submission period to allow additional time to finalize the proposed modifications to the IUR regulations, and to avoid finalizing...

Global status report on road safety : time for action

DOT National Transportation Integrated Search

2009-01-01

The Global status report on road safety reaffirms our understanding of road traffic injuries as a global health and development problem. More than 1.2 million people die on the world's road every year, and as many as 50 million others are injured. Ov...

Developing and Testing the Health Care Safety Hotline

PubMed Central

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

2017-01-01

Abstract This article describes the design, development, and testing of the Health Care Safety Hotline, a prototype consumer reporting system for patient safety events. The prototype was designed and developed with ongoing review by a technical expert panel and feedback obtained during a public comment period. Two health care delivery organizations in one metropolitan area collaborated with the researchers to demonstrate and evaluate the system. The prototype was deployed and elicited information from patients, family members, and caregivers through a website or an 800 phone number. The reports were considered useful and had little overlap with information received by the health care organizations through their usual risk management, customer service, and patient safety monitoring systems. However, the frequency of reporting was lower than anticipated, suggesting that further refinements, including efforts to raise awareness by actively soliciting reports from subjects, might be necessary to substantially increase the volume of useful reports. It is possible that a single technology platform could be built to meet a variety of different patient safety objectives, but it may not be possible to achieve several objectives simultaneously through a single consumer reporting system while also establishing trust with patients, caregivers, and providers. PMID:28845353

Patient Safety Competence of Nursing Students in Saudi Arabia: A Self-Reported Survey

PubMed Central

Colet, Paolo C.; Cruz, Jonas P.; Cruz, Charlie P.; Al-otaibi, Jazi; Qubeilat, Hikmet; Alquwez, Nahed

2015-01-01

Objective With the growing recognition of the significance of patient safety (PS) in educational institutions and health organizations, it is essential to understand the perspective of nursing students on their own PS competence. This study analyzed the self-reported PS competence of nursing students at a government university in Saudi Arabia. Methodology A cross-sectional self-reported survey of 191 respondents, using the Health Professional Education in Patient Safety Survey (H-PEPSS) was conducted. The survey tool reflected 6 key socio-cultural dimensions assessing competence in classroom and clinical setting. Results Female nursing students reported higher PS competence in both the classroom and clinical settings along the dimensions ‘working in teams’ and ‘communicating effectively’ while males reported higher competence in both settings as to the ‘managing safety risks’ and ‘understanding human and environmental factors’ dimensions. The respondents’ academic level and self–reported PS competence have weak negative correlation in the classroom while a strong negative correlation between the 2 variables existed in the clinical setting. Self-reported PS competence for the dimensions ‘working in teams’, ‘recognize and respond to remove immediate risks of harm’, and ‘culture of safety’ is significantly higher in classroom than in the clinical setting. Conclusion Generally, the Saudi nursing students reported varying levels of competence in the six dimensions of patient safety. Significant gap between the perceived PS competence was observed between learning settings. Educational and training interventions are suggested for implementation to bridge this gap. PMID:26715921

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...

77 FR 75699 - Pipeline Safety: Reporting of Exceedances of Maximum Allowable Operating Pressure

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-21

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No... AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA); DOT. ACTION: Notice; Issuance of... occurs. This reporting requirement is applicable to all gas transmission pipeline facility owners and...

Pre-surgery briefings and safety climate in the operating theatre.

PubMed

Allard, Jon; Bleakley, Alan; Hobbs, Adrian; Coombes, Lee

2011-08-01

In 2008, the WHO produced a surgical safety checklist against a background of a poor patient safety record in operating theatres. Formal team briefings are now standard practice in high-risk settings such as the aviation industry and improve safety, but are resisted in surgery. Research evidence is needed to persuade the surgical workforce to adopt safety procedures such as briefings. To investigate whether exposure to pre-surgery briefings is related to perception of safety climate. Three Safety Attitude Questionnaires, completed by operating theatre staff in 2003, 2004 and 2006, were used to evaluate the effects of an educational intervention introducing pre-surgery briefings. Individual practitioners who agree with the statement 'briefings are common in the operating theatre' also report a better 'safety climate' in operating theatres. The study reports a powerful link between briefing practices and attitudes towards safety. Findings build on previous work by reporting on the relationship between briefings and safety climate within a 4-year period. Briefings, however, remain difficult to establish in local contexts without appropriate team-based patient safety education. Success in establishing a safety culture, with associated practices, may depend on first establishing unidirectional, positive change in attitudes to create a safety climate.

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.

An assessment of traffic safety culture related to engagement in efforts to improve traffic safety : final report.

DOT National Transportation Integrated Search

2016-12-01

This final report summarizes the methods, results, conclusions, and recommendations derived from a survey conducted to understand values, beliefs, and attitudes regarding engagement in behaviors that impact the traffic safety of others. Results of th...

Safety Issues at the Defense Production Reactors. A Report to the U.S. Department of Energy.

ERIC Educational Resources Information Center

National Academy of Sciences - National Research Council, Washington, DC. Commission on Physical Sciences, Mathematics, and Resources.

This report provides an assessment of safety management, safety review, and safety methodology employed by the Department of Energy (DOE) and private contractors. Chapter 1, "The DOE Safety Framework," examines safety objectives for production reactors and processes to implement the objectives. Chapter 2, "Technical Issues,"…

Foremen's intervention to prevent falls and increase safety communication at residential construction sites.

PubMed

Kaskutas, Vicki; Buckner-Petty, Skye; Dale, Ann Marie; Gaal, John; Evanoff, Bradley A

2016-10-01

This research aimed to improve residential construction foremen's communication skills and safety behaviors of their crewmembers when working at heights. Eighty-four residential construction foremen participated in the 8-hr fall prevention and safety communication training. We compared pre- and post-intervention surveys from foremen and their crewmembers to measure the effect of training. Foremen and crewmembers' ratings showed improvements in fall prevention knowledge, behaviors, and safety communication and were sustained 6-months post-training, with emphasized areas demonstrating larger increases. Ratings were similar between foremen and crewmembers, suggesting that the foremen effectively taught their crew and assigned accurate ratings. Based upon associations between safety behaviors and reported falls observed in prior research, we would expect a 16.6% decrease in the one year cumulative incidence of self-reported falls post-intervention. This intervention improved safety knowledge and behaviors of a large number of workers by training construction foremen in fall prevention and safety communication skills. Am. J. Ind. Med. 59:823-831, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Reporting of meta-analyses of randomized controlled trials with a focus on drug safety: an empirical assessment.

PubMed

Hammad, Tarek A; Neyarapally, George A; Pinheiro, Simone P; Iyasu, Solomon; Rochester, George; Dal Pan, Gerald

2013-01-01

Due to the sparse nature of serious drug-related adverse events (AEs), meta-analyses combining data from several randomized controlled trials (RCTs) to evaluate drug safety issues are increasingly being conducted and published, influencing clinical and regulatory decision making. Evaluation of meta-analyses involves the assessment of both the individual constituent trials and the approaches used to combine them. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting framework is designed to enhance the reporting of systematic reviews and meta-analyses. However, PRISMA may not cover all critical elements useful in the evaluation of meta-analyses with a focus on drug safety particularly in the regulatory-public health setting. This work was conducted to (1) evaluate the adherence of a sample of published drug safety-focused meta-analyses to the PRISMA reporting framework, (2) identify gaps in this framework based on key aspects pertinent to drug safety, and (3) stimulate the development and validation of a more comprehensive reporting tool that incorporates elements unique to drug safety evaluation. We selected a sample of meta-analyses of RCTs based on review of abstracts from high-impact journals as well as top medical specialty journals between 2009 and 2011. We developed a preliminary reporting framework based on PRISMA with specific additional reporting elements critical for the evaluation of drug safety meta-analyses of RCTs. The reporting of pertinent elements in each meta-analysis was reviewed independently by two authors; discrepancies in the independent evaluations were resolved through discussions between the two authors. A total of 27 meta-analyses, 12 from highest impact journals, 13 from specialty medical journals, and 2 from Cochrane reviews, were identified and evaluated. The great majority (>85%) of PRISMA elements were addressed in more than half of the meta-analyses reviewed. However, the majority of meta

Guide for the Development of Safety Assessment Report (SAR)

DTIC Science & Technology

1987-08-01

Di ’:t ib ityioe I A,;!i~abiiity Codes Dist SpdIt ora bloe INSia OEapy r TABLE OF CONTENTS PAGE III SAFETY ASSESSMENT REPORT...above. Potential hazards associated with the maintenance of the turbine engine (i.e., use of cleaning agents ) are not addressed .in the accompanying

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...

Safety analysis report for the SR-101 inert reservoir package

DOT National Transportation Integrated Search

1998-11-01

Department of Energy (DOE) AL Weapons Surety Division (WSD) requires the SR-101 Inert Reservoir Package to : meet applicable hazardous material transportation requirements. This Safety Analysis Report (SAR) is based on : requirements in place at the ...

Food safety knowledge, attitudes and self-reported practices among Ontario high school students.

PubMed

Majowicz, Shannon E; Diplock, Kenneth J; Leatherdale, Scott T; Bredin, Chad T; Rebellato, Steven; Hammond, David; Jones-Bitton, Andria; Dubin, Joel A

2016-03-16

To measure the food safety knowledge, attitudes and self-reported practices of high school students in Ontario. We administered a school-wide paper survey to the student body (n = 2,860) of four Ontario high schools. We developed the survey by selecting questions from existing, validated questionnaires, prioritizing questions that aligned with the Canadian Partnership for Consumer Food Safety Education's educational messages and the food safety objectives from the 2013 Ontario High School Curriculum. One in five students reported currently handling food in commercial or public-serving venues; of these, 45.1% had ever taken a course that taught them how to prepare food (e.g., food and nutrition classes, food handler certification). Food safety knowledge among respondents was low. For example, 17.3% knew that the best way to determine whether hamburgers were cooked enough to eat was to measure the temperature with a food thermometer. Despite low knowledge, most respondents (72.7%) reported being confident that they could cook safe, healthy meals for themselves and their families. Safe food handling practices were frequently self-reported. Most students (86.5%) agreed that being able to cook safe, healthy meals was an important life skill, although their interest in learning about safe food handling and concern about foodborne disease were less pronounced. Our findings suggest that food safety knowledge is low, yet confidence in preparing safe, healthy meals is high, among high school students. Because work and volunteer opportunities put students in contact with both the public and food, this group is important to target for increased education about safe food handling.

The association between EMS workplace safety culture and safety outcomes.

PubMed

Weaver, Matthew D; Wang, Henry E; Fairbanks, Rollin J; Patterson, Daniel

2012-01-01

Prior studies have highlighted wide variation in emergency medical services (EMS) workplace safety culture across agencies. To determine the association between EMS workplace safety culture scores and patient or provider safety outcomes. We administered a cross-sectional survey to EMS workers affiliated with a convenience sample of agencies. We recruited these agencies from a national EMS management organization. We used the EMS Safety Attitudes Questionnaire (EMS-SAQ) to measure workplace safety culture and the EMS Safety Inventory (EMS-SI), a tool developed to capture self-reported safety outcomes from EMS workers. The EMS-SAQ provides reliable and valid measures of six domains: safety climate, teamwork climate, perceptions of management, working conditions, stress recognition, and job satisfaction. A panel of medical directors, emergency medical technicians and paramedics, and occupational epidemiologists developed the EMS-SI to measure self-reported injury, medical errors and adverse events, and safety-compromising behaviors. We used hierarchical linear models to evaluate the association between EMS-SAQ scores and EMS-SI safety outcome measures. Sixteen percent of all respondents reported experiencing an injury in the past three months, four of every 10 respondents reported an error or adverse event (AE), and 89% reported safety-compromising behaviors. Respondents reporting injury scored lower on five of the six domains of safety culture. Respondents reporting an error or AE scored lower for four of the six domains, while respondents reporting safety-compromising behavior had lower safety culture scores for five of the six domains. Individual EMS worker perceptions of workplace safety culture are associated with composite measures of patient and provider safety outcomes. This study is preliminary evidence of the association between safety culture and patient or provider safety outcomes.

[Efficacy, safety and comfort of compression therapy models in the immediate post-operative period after a greater saphenectomy. A prospective randomised study].

PubMed

Collazo Chao, Eliseo; Luque, María Antonia; González-Ripoll, Carmen

2010-10-01

There is still controversy on the best compression therapy after performing a greater saphenectomy. The purpose of this study is to establish whether the use of a controlled compression stocking has the same level of safety and efficacy as a compression bandage in the immediate post-operative period after a greater saphenectomy. A prospective, randomised, open-labelled study, comparing three groups: a) a conventional compression bandage for one week, b) a conventional compression bandage replaced by a controlled tubular compression stocking at 5h of its putting in place, c) immediate direct use of the controlled tubular compression stocking, was conducted on fifty-five consecutive outpatients with a greater saphenectomy in one of their legs, and who fulfilled the inclusion criteria. The working hypothesis was that the controlled tubular compression stocking could replace, in terms of efficacy, safety and comfort, the usual controlled compression in the immediate post-operative period after saphenous vein stripping. The analysis variables were pain, control of bleeding, analgesics in the post-operative period, bruising, incapacity during the first week after the operation and comfort level. There were no statistically significant differences found between the three types of compressions studied as regards, safety, efficacy, comfort level, pain and analgesic consumption, but there was as regards the level of convenience in favour of the use of the stocking. The controlled tubular compression stocking can replace the compression bandage with more advantages after greater saphenous vein stripping in outpatients, having the same safety and efficacy. Copyright © 2009 AEC. Published by Elsevier Espana. All rights reserved.

Implementation of the Generic Safety Analysis Report - Lessons Learned

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

Blanchard, A.

1999-06-02

The Savannah River Site has completed the development, review and approval process for the Generic Safety Analysis Report (GSAR) and implemented this information in facility SARs and BIOs. This includes the yearly revision of the GSAR and the facility-specific SARs. The process has provided us with several lessons learned.

National Dam Safety Program. Upper Mohawk Lake Dam (NJ00292), Delaware River Basin, Tributary to Paulins Kill River, Sussex County, New Jersey. Phase I Inspection Report.

DTIC Science & Technology

1981-07-01

AD-AI03 500 NEW JERSEY DEPT OF ENVIRONMENTAL PROTECTION TRENTON --ETC F/G 13/13 NATIONAL DAM SAFETY PROGRA . UPPER MOHAWK LAKE DAM (NJOO292) D0-TC...NATIONAL DAM SAFETY PROGRAM DTIC UG 3 1981 PRO F, SA G DISTl-%iL ~ Lj,,. U L TED. DEPARTMENT OF THE ARMY Philadelphie District Corps oF Engineers...GOVT ACCESSION Ni. 3. RECIPLLT*S CATALOG NUMBER ib EN/NAP-�/NJO0292-81/07 0, u)-, c J . () 4. TITLE (and Subtl) S. TYPE OF REPORT a PERIOD

Final safety analysis report for the Galileo Mission: Volume 1, Reference design document

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

Not Available

The Galileo mission uses nuclear power sources called Radioisotope Thermoelectric Generators (RTGs) to provide the spacecraft's primary electrical power. Because these generators contain nuclear material, a Safety Analysis Report (SAR) is required. A preliminary SAR and an updated SAR were previously issued that provided an evolving status report on the safety analysis. As a result of the Challenger accident, the launch dates for both Galileo and Ulysses missions were later rescheduled for November 1989 and October 1990, respectively. The decision was made by agreement between the DOE and the NASA to have a revised safety evaluation and report (FSAR) preparedmore » on the basis of these revised vehicle accidents and environments. The results of this latest revised safety evaluation are presented in this document (Galileo FSAR). Volume I, this document, provides the background design information required to understand the analyses presented in Volumes II and III. It contains descriptions of the RTGs, the Galileo spacecraft, the Space Shuttle, the Inertial Upper Stage (IUS), the trajectory and flight characteristics including flight contingency modes, and the launch site. There are two appendices in Volume I which provide detailed material properties for the RTG.« less

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...

LANL Safety Conscious Work Environment (SCWE) Self-Assessment

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

Hargis, Barbara C.

2014-01-29

On December 21, 2012 Secretary of Energy Chu transmitted to the Defense Nuclear Facilities Safety Board (DNFSB) revised commitments on the implementation plan for Safety Culture at the Waste Treatment and Immobilization Plant. Action 2-5 was revised to require contractors and federal organizations to complete Safety Conscious Work Environment (SCWE) selfassessments and provide reports to the appropriate U.S. Department of Energy (DOE) - Headquarters Program Office by September 2013. Los Alamos National Laboratory (LANL) planned and conducted a Safety Conscious Work Environment (SCWE) Self-Assessment over the time period July through August, 2013 in accordance with the SCWE Self-Assessment Guidance providedmore » by DOE. Significant field work was conducted over the 2-week period August 5-16, 2013. The purpose of the self-assessment was to evaluate whether programs and processes associated with a SCWE are in place and whether they are effective in supporting and promoting a SCWE.« less

A 2-night, 3-period, crossover study of ramelteon's efficacy and safety in older adults with chronic insomnia.

PubMed

Roth, Thomas; Seiden, David; Wang-Weigand, Sherry; Zhang, Jeffrey

2007-05-01

To assess the efficacy and safety of ramelteon, a selective melatonin MT1/MT2-receptor agonist, for insomnia treatment in older adults. In a randomized, 9-week, 3-period crossover trial conducted at 17 sleep centers, older adults (N = 100) with chronic primary insomnia (37 men, 63 women; mean age [range], 70.7 [65-83] years) were administered placebo, ramelteon 4 mg, and ramelteon 8 mg in three treatment phases for two consecutive nights. Each phase was separated by 5- to 12-day washout periods. Sleep was monitored via polysomnography. Subjective sleep parameters, using a Postsleep Questionnaire, were recorded, and residual pharmacologic effects were assessed. Statistically significant reductions in latency to persistent sleep were observed with both ramelteon 4 mg and 8 mg compared to placebo (28.7 min vs. 38.4 min, p < 0.001; 30.8 min vs. 38.4 min, p = 0.005, respectively). Total sleep time (p = 0.036 and p = 0.007, respectively) and sleep efficiency (p = 0.037 and p = 0.007, respectively) were also significantly improved with ramelteon 4 mg and 8 mg compared to placebo. Statistically significant reductions in subjective sleep latency on a Postsleep Questionnaire were reported with ramelteon 4 mg versus placebo (p = 0.037), but not ramelteon 8 mg (p = 0.120); no significant differences on other subjective sleep assessments were reported. A lack of power limits interpretation of self-reported sleep parameters. Incidences of adverse events considered treatment related were placebo (7%), ramelteon 4 mg (11%), and ramelteon 8 mg (5%). No residual pharmacologic effects were observed via Digit Symbol Substitution Test, memory recall tests (immediate and delayed), visual analog scales (feelings and mood), and Postsleep Questionnaire (level of alertness and ability to concentrate). In older adults with chronic primary insomnia, ramelteon produced significant reductions in latency to persistent sleep and increases in total sleep time and sleep efficacy, and showed no

The association between EMS workplace safety culture and safety outcomes

PubMed Central

Weaver, Matthew D.; Wang, Henry E.; Fairbanks, Rollin J.; Patterson, Daniel

2012-01-01

Objective Prior studies have highlighted wide variation in EMS workplace safety culture across agencies. We sought to determine the association between EMS workplace safety culture scores and patient or provider safety outcomes. Methods We administered a cross-sectional survey to EMS workers affiliated with a convenience sample of agencies. We recruited these agencies from a national EMS management organization. We used the EMS Safety Attitudes Questionnaire (EMS-SAQ) to measure workplace safety culture and the EMS Safety Inventory (EMS-SI), a tool developed to capture self-reported safety outcomes from EMS workers. The EMS-SAQ provides reliable and valid measures of six domains: safety climate, teamwork climate, perceptions of management, perceptions of working conditions, stress recognition, and job satisfaction. A panel of medical directors, paramedics, and occupational epidemiologists developed the EMS-SI to measure self-reported injury, medical errors and adverse events, and safety-compromising behaviors. We used hierarchical linear models to evaluate the association between EMS-SAQ scores and EMS-SI safety outcome measures. Results Sixteen percent of all respondents reported experiencing an injury in the past 3 months, four of every 10 respondents reported an error or adverse event (AE), and 90% reported safety-compromising behaviors. Respondents reporting injury scored lower on 5 of the 6 domains of safety culture. Respondents reporting an error or AE scored lower for 4 of the 6 domains, while respondents reporting safety-compromising behavior had lower safety culture scores for 5 of 6 domains. Conclusions Individual EMS worker perceptions of workplace safety culture are associated with composite measures of patient and provider safety outcomes. This study is preliminary evidence of the association between safety culture and patient or provider safety outcomes. PMID:21950463

40 CFR 63.130 - Transfer operations provisions-periodic recordkeeping and reporting.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 9 2011-07-01 2011-07-01 false Transfer operations provisions-periodic... § 63.130 Transfer operations provisions—periodic recordkeeping and reporting. (a) Each owner or... § 63.127 of this subpart, and listed in table 7 of this subpart or specified by the Administrator in...

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.

Evidence report : diabetes and commercial motor vehicle driver safety (expedited review) : September 8, 2006.

DOT National Transportation Integrated Search

2006-09-08

This report is comprised of research conducted to analyze the impact of Diabetes on Commercial Motor Vehicle Driver Safety. Federal Motor Carrier Safety Administration considers evidence, expert recommendations, and other data, however, all proposed ...

SBAR improves communication and safety climate and decreases incident reports due to communication errors in an anaesthetic clinic: a prospective intervention study.

PubMed

Randmaa, Maria; Mårtensson, Gunilla; Leo Swenne, Christine; Engström, Maria

2014-01-21

We aimed to examine staff members' perceptions of communication within and between different professions, safety attitudes and psychological empowerment, prior to and after implementation of the communication tool Situation-Background-Assessment-Recommendation (SBAR) at an anaesthetic clinic. The aim was also to study whether there was any change in the proportion of incident reports caused by communication errors. A prospective intervention study with comparison group using preassessments and postassessments. Questionnaire data were collected from staff in an intervention (n=100) and a comparison group (n=69) at the anaesthetic clinic in two hospitals prior to (2011) and after (2012) implementation of SBAR. The proportion of incident reports due to communication errors was calculated during a 1-year period prior to and after implementation. Anaesthetic clinics at two hospitals in Sweden. All licensed practical nurses, registered nurses and physicians working in the operating theatres, intensive care units and postanaesthesia care units at anaesthetic clinics in two hospitals were invited to participate. Implementation of SBAR in an anaesthetic clinic. The primary outcomes were staff members' perception of communication within and between different professions, as well as their perceptions of safety attitudes. Secondary outcomes were psychological empowerment and incident reports due to error of communication. In the intervention group, there were statistically significant improvements in the factors 'Between-group communication accuracy' (p=0.039) and 'Safety climate' (p=0.011). The proportion of incident reports due to communication errors decreased significantly (p<0.0001) in the intervention group, from 31% to 11%. Implementing the communication tool SBAR in anaesthetic clinics was associated with improvement in staff members' perception of communication between professionals and their perception of the safety climate as well as with a decreased proportion of

Identification of potentially emerging food safety issues by analysis of reports published by the European Community's Rapid Alert System for Food and Feed (RASFF) during a four-year period.

PubMed

Kleter, G A; Prandini, A; Filippi, L; Marvin, H J P

2009-05-01

The SAFE FOODS project undertakes to design a new approach towards the early identification of emerging food safety hazards. This study explored the utility of notifications filed through RASFF, the European Commission's Rapid Alert System for Food and Feed, to identify emerging trends in food safety issues. RASFF information and alert notifications published in the four-year period of July 2003-June 2007 were assigned to categories of products and hazards. For chronological trend analysis, a basic time unit of three months was chosen. Data within each hazard category were analyzed for chronological trends, relationships between product and hazard categories, regions of origin, and countries filing the notifications. Conspicuous trends that were observed included a rise in the incidence of food contact substances, particularly 2-isopropyl-thioxanthone, as well as of chemical substances migrating from utensils and fraud-related issues. Temporary increases were noted in the incidences of the unauthorized dye Para Red, genetically modified organisms, the pesticide isophenfos-methyl, and herring worm, Anisakis simplex. National and European authorities themselves have signaled these conspicuous trends and taken measures. It is recommended to add complementary data to RASFF data, including safety assessments, risk management measures, background data on hazards and surveillance patterns, for a holistic approach towards early identification of emerging hazards.

Workplace Violence and Perceptions of Safety Among Emergency Department Staff Members: Experiences, Expectations, Tolerance, Reporting, and Recommendations.

PubMed

Copeland, Darcy; Henry, Melissa

Workplace violence (WPV) is a widely recognized problem in emergency departments (EDs). The majority of WPV studies do not include nonclinical staff and do not address expectations of violence, tolerance to violence, or perceptions of safety. Among a multidisciplinary sample of ED staff members, specific study aims were to (a) describe exposure to WPV; (b) describe perceptions of safety, tolerance to violence, and expectation of violence; (c) describe reporting behaviors and perceived barriers to reporting violence; (d) examine relationships between demographic variables, experiences of violence, tolerance to violence, perceptions of safety, and reporting behaviors; and (e) identify perceptions of viable interventions to improve workplace safety. A cross-sectional design was used to survey ED staff members in a Level 1 Shock Trauma center. Eleven disciplines were represented in 147 completed surveys; 88% of respondents reported exposure to WPV in the previous 6 months. Members of every discipline reported exposure to WPV; 98% of the sample felt safe at work and 64% felt violence was an expected part of the job. Most violence was not reported, primarily because "nobody was hurt." Emergency department staff members expected and experienced violence; nevertheless, there was a widespread perception of safety. Perceptions of safety and reasons for not reporting did not mirror previous findings. The WPV exposure is not isolated to clinical staff members and occurs even when prevention strategies are in place. The definition of WPV and the individual's interpretation of the event might preclude reporting.

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

PubMed

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

2011-02-01

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

Return to driving after arthroscopic rotator cuff repair: patient-reported safety and maneuverability.

PubMed

Gholson, J Joseph; Lin, Albert; McGlaston, Timothy; DeAngelis, Joseph; Ramappa, Arun

2015-01-01

This survey investigated patients' return to driving after rotator cuff surgery, to determine whether pain, weakness, sling use, and narcotics correlate with self-assessed safety and maneuvering. Fifty-four patients (80.6% of those eligible) were surveyed 4 months after surgery. Return to driving ranged widely from same day to 4 months, with two not driving at 4 months; 12% reported narcotics use and 33% reported sling use. Drivers reporting weakness were more likely to feel unsafe (p = .02) and more likely to report difficulty maneuvering (p <.01). Drivers reporting pain were more likely to feel unsafe (p < .01) and more likely to report difficulty maneuvering their vehicle (p < .01). Patient-reported return to driving does not correspond to perceived safety; pain and weakness correspond with feeling unsafe and difficulty maneuvering. Although subjective, clinicians may find these self-assessments predictive when counseling patients on return to driving.

Evidence report : psychiatric disorders and commercial motor vehicle driver safety.

DOT National Transportation Integrated Search

2008-08-29

This report was prepared by ECRI Institute under subcontract to MANILA Consulting Group, Inc., which holds prime GS-10F-0177N/DTMC75-06-F-00039 with the Department of Transportations Federal Motor Carrier Safety Administration. ECRI Institute is a...

Evidence report : Musculoskeletal disorders and commercial motor vehicle driver safety.

DOT National Transportation Integrated Search

2008-04-30

This report was prepared by ECRI Institute under subcontract to MANILA Consulting Group, Inc., which holds prime GS-10F-0177N/DTMC75-06-F-00039 with the Department of Transportations Federal Motor Carrier Safety Administration. ECRI Institute is a...

1998 motor vehicle occupant safety survey. Volume 1, methodology report

DOT National Transportation Integrated Search

2000-03-01

This is the Methodology Report for the 1998 Motor Vehicle Occupant Safety Survey. The survey is conducted on a biennial basis (initiated in 1994), and is administered by telephone to a randomly selected national sample. Two questionnaires are used, e...

Achieving compatibility of state and federal safety requirements : a report to the Secretary of Transportation.

DOT National Transportation Integrated Search

1990-08-01

The Commercial Motor Vehicle Safety Regulatory Review Panel (Safety : Panel) has prepared this report in response to Sections 207, 208, and 209 of : the Motor Carrier Safety Act of 1984 (Public Law 98-554). A major goal of the : 1984 Act was to achie...

Analytical Chemistry Division. Annual progress report for period ending December 31, 1980

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

Lyon, W.S.

1981-05-01

This report is divided into: analytical methodology; mass and emission spectrometry; technical support; bio/organic analysis; nuclear and radiochemical analysis; quality assurance, safety, and tabulation of analyses; supplementary activities; and presentation of research results. Separate abstracts were prepared for the technical support, bio/organic analysis, and nuclear and radiochemical analysis. (DLC)

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.

Aerospace safety advisory panel

NASA Technical Reports Server (NTRS)

1995-01-01

The Aerospace Safety Advisory Panel (ASAP) monitored NASA's activities and provided feedback to the NASA Administrator, other NASA officials and Congress throughout the year. Particular attention was paid to the Space Shuttle, its launch processing and planned and potential safety improvements. The Panel monitored Space Shuttle processing at the Kennedy Space Center (KSC) and will continue to follow it as personnel reductions are implemented. There is particular concern that upgrades in hardware, software, and operations with the potential for significant risk reduction not be overlooked due to the extraordinary budget pressures facing the agency. The authorization of all of the Space Shuttle Main Engine (SSME) Block II components portends future Space Shuttle operations at lower risk levels and with greater margins for handling unplanned ascent events. Throughout the year, the Panel attempted to monitor the safety activities related to the Russian involvement in both space and aeronautics programs. This proved difficult as the working relationships between NASA and the Russians were still being defined as the year unfolded. NASA's concern for the unique safety problems inherent in a multi-national endeavor appears appropriate. Actions are underway or contemplated which should be capable of identifying and rectifying problem areas. The balance of this report presents 'Findings and Recommendations' (Section 2), 'Information in Support of Findings and Recommendations' (Section 3) and Appendices describing Panel membership, the NASA response to the March 1994 ASAP report, and a chronology of the panel's activities during the reporting period (Section 4).

Police accident report forms: safety device coding and enacted laws.

PubMed

Brock, K; Lapidus, G

2008-12-01

Safety device coding on state police accident report (PAR) forms was compared with provisions in state traffic safety laws. PAR forms were obtained from all 50 states and the District of Columbia (states/DC). For seat belts, 22 states/DC had a primary seat belt enforcement law vs 50 with a PAR code. For car seats, all 51 states/DC had a law and a PAR code. For booster seats, 39 states/DC had a law vs nine with a PAR code. For motorcycle helmets, 21 states/DC had an all-age rider helmet law and another 26 a partial-age law vs 50 with a PAR code. For bicycle helmets, 21 states/DC had a partial-age rider helmet law vs 48 with a PAR code. Therefore gaps in the ability of states to fully record accident data reflective of existing state traffic safety laws are revealed. Revising the PAR forms in all states to include complete variables for safety devices should be an important priority, independent of the laws.

An improved bridge safety index for narrow bridges.

DOT National Transportation Integrated Search

1983-08-01

In this report, a new bridge safety index is developed based upon an extensive : statistical study of accident data on 78 bridges. A total of 655 accidents : were recorded at these bridges over the six-year period between 1974 and 1979. : Cluster ana...

Teaching Technology by Assessing Vehicle Safety

ERIC Educational Resources Information Center

Lazaros, Edward J.

2012-01-01

According to the National Center for Injury Prevention and Control, motor vehicle crashes are the leading cause of death among Americans aged 2-34. Many states have adopted periodic motor vehicle inspection (PMVI) to ensure the safety of the highways, and states that have adopted PMVI report a reduction in highway fatalities. Deaths and injuries…

Report to NASA Committee on Aircraft Operating Problems Relative to Aviation Safety Engineering and Research Activities

NASA Technical Reports Server (NTRS)

1963-01-01

The following report highlights some of the work accomplished by the Aviation Safety Engineering and Research Division of the Flight Safety Foundations since the last report to the NASA Committee on Aircraft Operating Problems on 22 May 1963. The information presented is in summary form. Additional details may be provided upon request of the reports themselves may be obtained from AvSER.

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.

Safety compliance and safety climate: A repeated cross-sectional study in the oil and gas industry.

PubMed

Kvalheim, Sverre A; Dahl, Øyvind

2016-12-01

Violations of safety rules and procedures are commonly identified as a causal factor in accidents in the oil and gas industry. Extensive knowledge on effective management practices related to improved compliance with safety procedures is therefore needed. Previous studies of the causal relationship between safety climate and safety compliance demonstrate that the propensity to act in accordance with prevailing rules and procedures is influenced to a large degree by workers' safety climate. Commonly, the climate measures employed differ from one study to another and identical measures of safety climate are seldom tested repeatedly over extended periods of time. This research gap is addressed in the present study. The study is based on a survey conducted four times among sharp-end workers of the Norwegian oil and gas industry (N=31,350). This is done by performing multiple tests (regression analysis) over a period of 7years of the causal relationship between safety climate and safety compliance. The safety climate measure employed is identical across the 7-year period. Taking all periods together, the employed safety climate model explained roughly 27% of the variance in safety compliance. The causal relationship was found to be stable across the period, thereby increasing the reliability and the predictive validity of the factor structure. The safety climate factor that had the most powerful effect on safety compliance was work pressure. The factor structure employed shows high predictive validity and should therefore be relevant to organizations seeking to improve safety in the petroleum sector. The findings should also be relevant to other high-hazard industries where safety rules and procedures constitute a central part of the approach to managing safety. Copyright © 2016 Elsevier Ltd and National Safety Council. All rights reserved.

Characteristics of effective health and safety committees: survey results.

PubMed

Morse, Tim; Bracker, Anne; Warren, Nicholas; Goyzueta, Jeanette; Cook, Matthew

2013-02-01

Although perhaps the most common worker-management structure, there has been surprisingly little research on describing and evaluating the characteristics of health and safety committees. A survey of 380 health and safety committee members from 176 manufacturing workplaces was supplemented with administrative data and compared with reported workers' compensation rates. Survey respondents also reported perceptions of overall safety, committee, effectiveness, committee activities, and "best practices." Extensive descriptive data is presented, including a mean of 8.7 members per committee spending 1,167 hr per year on committee business for an estimate of $40,500 worth of time per committee. Higher speed to correct action items, a focus on ergonomics, and planning for safety training was associated with lower injury rates. The discrepancy between managers and hourly committee members in estimating overall safety was strongly positively associated with injury rates. Communications and worker involvement may be important to address discrepancy issues. Prospective studies are needed to distinguish directionality of associations. Copyright © 2012 Wiley Periodicals, Inc.

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.

Child Safety: A State of the State Report. An Arkansas Kids Count Special Report.

ERIC Educational Resources Information Center

Huddleston, Richard A.

This Kids Count report uses data from the Arkansas Department of Health to examine statewide trends in child safety. The findings suggested that in 1996, about one-third of child deaths in Arkansas were due to non-natural causes, with substantial racial and sex differences. Causes such as accidents, homicides, and suicides were more common for…

76 FR 47262 - Brookwood-Sago Mine Safety Grants

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-04

... industry during the current reporting period. Pre-test and post- test results of trainees. Course... funding ends. 2. Agency creates training Increase number of Pre-test and post- materials and improves quality educational test results of the safety. materials developed. training materials. Provide 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...

Ports and Waterways Safety Assessment Workshop Report. Kahului Harbor, Maui, Hawaii, 27-28 August 2009

DTIC Science & Technology

2009-08-28

and Waterways Safety Assessment Workshop Report Maui, Hawaii 27 - 28 August 2009 Kahului Harbor Report Documentation Page Form ApprovedOMB...00-00-2009 to 00-00-2009 4. TITLE AND SUBTITLE Ports and Waterways Safety Assessment: Maui, Hawaii 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c...Harbor, Maui, Hawaii 27 - 28 August 2009 Table of Contents Page Introduction

Interference with activities due to pain and fatigue: Accuracy of ratings across different reporting periods

PubMed Central

Broderick, Joan E.; Schneider, Stefan; Schwartz, Joseph E.; Stone, Arthur A.

2010-01-01

Purpose This study examined the impact of different reporting period lengths on the accuracy of items measuring interference due to pain and fatigue with work, walking, and relations with others. Methods Six items from well-established instruments (Brief Pain Inventory, Brief Fatigue Inventory, SF-36) were investigated in a prospective study of 117 patients with chronic rheumatological illness. Daily ratings were compared with recall ratings of 1, 3, 7, and 28-day reporting periods. Results The level of recall ratings (RRs) for reporting periods of 3 days or more were significantly higher than the level of aggregated end-of-day (EOD) ratings. Correspondence between aggregated EOD and RRs was good (r ≥ .80) regardless of the length of the reporting period. Ratings of interference for a single day were highly correlated with aggregated EOD for up to 14 days prior to the single rating (r ≥ .76). Conclusions Recall ratings with reporting periods of up to a month yield good correspondence with aggregated daily ratings, although the absolute level of the rating will be inflated for recall periods of 3 days or longer. PMID:20535565

Periodic catatonia with long-term treatment: a case report.

PubMed

Chen, Ruei-An; Huang, Tiao-Lai

2017-09-29

Periodic catatonia has long been a challenging diagnosis and there are no absolute guidelines for treatment when precipitating factors are also unclear. We report a schizophrenia patient with periodic catatonia with a 15-year treatment course. A possible correlation between decreased daylight exposure and periodic attacks has been observed. We describe a 49-year-old woman with periodic catatonia associated with schizophrenia with 15 years of follow-up. The patient was treated with the antipsychotics risperidone, haloperidol, loxapine and quetiapine, but catatonia still relapsed once per year during the first few years of her disease course. The treatment was consequently been switched to clozapine due to fluctuated psychotic illness, and a longer duration of remittance was achieved. Lorazepam-diazepam protocol was used for rapid relief of catatonic symptoms, and was able to significantly shorten the duration of the symptoms. In addition, we observed a possible correlation between catatonic episodes and decreased daylight exposure during the 15-year duration. Successful treatment of acute periodic catatonia was achieved with a lorazepam-diazepam protocol, and the patient remained in remission for a longer duration under clozapine treatment. Besides, the possibility of decreased daylight exposure acting as a precipitating factor was observed during our 15 years of follow-up.

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.

76 FR 10524 - Federal Motor Vehicle Safety Standards, Ejection Mitigation; Phase-In Reporting Requirements...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-25

... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Parts 571 and 585 [Docket No. NHTSA-2011-0004] RIN 2127-AK23 Federal Motor Vehicle Safety Standards, Ejection Mitigation; Phase-In Reporting Requirements; Incorporation by Reference Correction In rule document 2011-547...

[Safety monitoring of cell-based medicinal products (CBMPs)].

PubMed

Funk, Markus B; Frech, Marion; Spranger, Robert; Keller-Stanislawski, Brigitte

2015-11-01

Cell-based medicinal products (CBMPs), a category of advanced-therapy medicinal products (ATMPs), are authorised for the European market by the European Commission by means of the centralized marketing authorisation. By conforming to the German Medicinal Products Act (Sec. 4b AMG), national authorisation can be granted by the Paul-Ehrlich-Institut in Germany exclusively for ATMPs not based on a routine manufacturing procedure. In both procedures, quality, efficacy, and safety are evaluated and the risk-benefit balance is assessed. For the centralised procedure, mainly controlled clinical trial data must be submitted, whereas the requirements for national procedures could be modified corresponding to the stage of development of the ATMP. After marketing authorization, the marketing authorization/license holder is obligated to report all serious adverse reactions to the competent authority and to provide periodic safety update reports. If necessary, post-authorization safety studies could be imposed. On the basis of these regulatory measures, the safety of advanced therapies can be monitored and improved.

45 CFR 1386.23 - Periodic reports: Protection and Advocacy System.

Code of Federal Regulations, 2010 CFR

2010-10-01

... HUMAN DEVELOPMENT SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION ON DEVELOPMENTAL DISABILITIES, DEVELOPMENTAL DISABILITIES PROGRAM FORMULA GRANT PROGRAMS State System for Protection and Advocacy of the Rights of Individuals with Developmental Disabilities § 1386.23 Periodic reports...

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

Code of Federal Regulations, 2013 CFR

2013-01-01

...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2013-01-01 2013-01-01 false Contents of applications; technical information in final...

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

Code of Federal Regulations, 2012 CFR

2012-01-01

...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2012-01-01 2012-01-01 false Contents of applications; technical information in final...

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

Code of Federal Regulations, 2014 CFR

2014-01-01

...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2014-01-01 2014-01-01 false Contents of applications; technical information in final...

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

Code of Federal Regulations, 2011 CFR

2011-01-01

...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2011-01-01 2011-01-01 false Contents of applications; technical information in final...

Mandatory safety belt use legislation : alternatives for Virginia lawmakers : final report.

DOT National Transportation Integrated Search

1986-01-01

This report discusses the current environment which would influence the consideration of a mandatory safety belt use law in Virginia. First, the regulatory context fostered by the U. S. Department of Transportation's issuance of federal motor vehicle...

47 CFR 80.304 - Watch requirement during silence periods.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 5 2010-10-01 2010-10-01 false Watch requirement during silence periods. 80... Safety Watches § 80.304 Watch requirement during silence periods. Each ship station operating on... safety messages, ship stations must not transmit during the silence periods on 2182 kHz. [69 FR 64673...