Lift truck safety review

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

Cadwallader, L.C.

1997-03-01

This report presents safety information about powered industrial trucks. The basic lift truck, the counterbalanced sit down rider truck, is the primary focus of the report. Lift truck engineering is briefly described, then a hazard analysis is performed on the lift truck. Case histories and accident statistics are also given. Rules and regulations about lift trucks, such as the US Occupational Safety an Health Administration laws and the Underwriter`s Laboratories standards, are discussed. Safety issues with lift trucks are reviewed, and lift truck safety and reliability are discussed. Some quantitative reliability values are given.

Recognising safety critical events: can automatic video processing improve naturalistic data analyses?

PubMed

Dozza, Marco; González, Nieves Pañeda

2013-11-01

New trends in research on traffic accidents include Naturalistic Driving Studies (NDS). NDS are based on large scale data collection of driver, vehicle, and environment information in real world. NDS data sets have proven to be extremely valuable for the analysis of safety critical events such as crashes and near crashes. However, finding safety critical events in NDS data is often difficult and time consuming. Safety critical events are currently identified using kinematic triggers, for instance searching for deceleration below a certain threshold signifying harsh braking. Due to the low sensitivity and specificity of this filtering procedure, manual review of video data is currently necessary to decide whether the events identified by the triggers are actually safety critical. Such reviewing procedure is based on subjective decisions, is expensive and time consuming, and often tedious for the analysts. Furthermore, since NDS data is exponentially growing over time, this reviewing procedure may not be viable anymore in the very near future. This study tested the hypothesis that automatic processing of driver video information could increase the correct classification of safety critical events from kinematic triggers in naturalistic driving data. Review of about 400 video sequences recorded from the events, collected by 100 Volvo cars in the euroFOT project, suggested that drivers' individual reaction may be the key to recognize safety critical events. In fact, whether an event is safety critical or not often depends on the individual driver. A few algorithms, able to automatically classify driver reaction from video data, have been compared. The results presented in this paper show that the state of the art subjective review procedures to identify safety critical events from NDS can benefit from automated objective video processing. In addition, this paper discusses the major challenges in making such video analysis viable for future NDS and new potential

The objective impact of clinical peer review on hospital quality and safety.

PubMed

Edwards, Marc T

2011-01-01

Despite its importance, the objective impact of clinical peer review on the quality and safety of care has not been studied. Data from 296 acute care hospitals show that peer review program and related organizational factors can explain up to 18% of the variation in standardized measures of quality and patient safety. The majority of programs rely on an outmoded and dysfunctional process model. Adoption of best practices informed by the continuing study of peer review program effectiveness has the potential to significantly improve patient outcomes.

Practicing chemical process safety: a look at the layers of protection.

PubMed

Sanders, Roy E

2004-11-11

This presentation will review a few public perceptions of safety in chemical plants and refineries, and will compare these plant workplace risks to some of the more traditional occupations. The central theme of this paper is to provide a "within-the-fence" view of many of the process safety practices that world class plants perform to pro-actively protect people, property, profits as well as the environment. It behooves each chemical plant and refinery to have their story on an image-rich presentation to stress stewardship and process safety. Such a program can assure the company's employees and help convince the community that many layers of safety protection within our plants are effective, and protect all from harm.

Postharvest processes of edible insects in Africa: A review of processing methods, and the implications for nutrition, safety and new products development.

PubMed

Mutungi, C; Irungu, F G; Nduko, J; Mutua, F; Affognon, H; Nakimbugwe, D; Ekesi, S; Fiaboe, K K M

2017-08-30

In many African cultures, insects are part of the diet of humans and domesticated animals. Compared to conventional food and feed sources, insects have been associated with a low ecological foot print because fewer natural resources are required for their production. To this end, the Food and Agriculture Organization of the United Nations recognized the role that edible insects can play in improving global food and nutrition security; processing technologies, as well as packaging and storage techniques that improve shelf-life were identified as being crucial. However, knowledge of these aspects in light of nutritional value, safety, and functionality is fragmentary and needs to be consolidated. This review attempts to contribute to this effort by evaluating the available evidence on postharvest processes for edible insects in Africa, with the aim of identifying areas that need research impetus. It further draws attention to potential postharvest technology options for overcoming hurdles associated with utilization of insects for food and feed. A greater research thrust is needed in processing and this can build on traditional knowledge. The focus should be to establish optimal techniques that improve presentation, quality and safety of products, and open possibilities to diversify use of edible insects for other benefits.

Timing of Formal Phase Safety Reviews for Large-Scale Integrated Hazard Analysis

NASA Technical Reports Server (NTRS)

Massie, Michael J.; Morris, A. Terry

2010-01-01

Integrated hazard analysis (IHA) is a process used to identify and control unacceptable risk. As such, it does not occur in a vacuum. IHA approaches must be tailored to fit the system being analyzed. Physical, resource, organizational and temporal constraints on large-scale integrated systems impose additional direct or derived requirements on the IHA. The timing and interaction between engineering and safety organizations can provide either benefits or hindrances to the overall end product. The traditional approach for formal phase safety review timing and content, which generally works well for small- to moderate-scale systems, does not work well for very large-scale integrated systems. This paper proposes a modified approach to timing and content of formal phase safety reviews for IHA. Details of the tailoring process for IHA will describe how to avoid temporary disconnects in major milestone reviews and how to maintain a cohesive end-to-end integration story particularly for systems where the integrator inherently has little to no insight into lower level systems. The proposal has the advantage of allowing the hazard analysis development process to occur as technical data normally matures.

Report of the Shuttle Processing Review Team

NASA Technical Reports Server (NTRS)

1993-01-01

The intent of this report is to summarize the assessment of the shuttle processing operations at the Kennedy Space Center (KSC) as requested by the NASA Administrator. He requested a team reaffirmation that safety is the number one priority and review operations to ensure confidence in the shuttle processing procedures at KSC.

Rodent Control Pesticide Safety Review

EPA Pesticide Factsheets

EPA completed a safety review in 2008 of rat and mouse poison products. Many companies' products have our safety measures that reduce risks to humans, pets, and non-target wildlife. Products must be sold with bait stations that securely contain the poison.

The Cosmetic Ingredient Review Program-Expert Safety Assessments of Cosmetic Ingredients in an Open Forum.

PubMed

Boyer, Ivan J; Bergfeld, Wilma F; Heldreth, Bart; Fiume, Monice M; Gill, Lillian J

The Cosmetic Ingredient Review (CIR) is a nonprofit program to assess the safety of ingredients in personal care products in an open, unbiased, and expert manner. Cosmetic Ingredient Review was established in 1976 by the Personal Care Products Council (PCPC), with the support of the US Food and Drug Administration (USFDA) and the Consumer Federation of America (CFA). Cosmetic Ingredient Review remains the only scientific program in the world committed to the systematic, independent review of cosmetic ingredient safety in a public forum. Cosmetic Ingredient Review operates in accordance with procedures modeled after the USFDA process for reviewing over-the-counter drugs. Nine voting panel members are distinguished, such as medical professionals, scientists, and professors. Three nonvoting liaisons are designated by the USFDA, CFA, and PCPC to represent government, consumer, and industry, respectively. The annual rate of completing safety assessments accelerated from about 100 to more than 400 ingredients by implementing grouping and read-across strategies and other approaches. As of March 2017, CIR had reviewed 4,740 individual cosmetic ingredients, including 4,611 determined to be safe as used or safe with qualifications, 12 determined to be unsafe, and 117 ingredients for which the information is insufficient to determine safety. Examples of especially challenging safety assessments and issues are presented here, including botanicals. Cosmetic Ingredient Review continues to strengthen its program with the ongoing cooperation of the USFDA, CFA, the cosmetics industry, and everyone else interested in contributing to the process.

NASA/MSFC FY-82 atmospheric processes research review

NASA Technical Reports Server (NTRS)

Turner, R. E. (Compiler)

1982-01-01

The NASA/MSFC FY-82 Atmospheric Processes Research Program was reviewed. The review covered research tasks in the areas of upper atmosphere, global weather, and severe storms and local weather. Also included was research on aviation safety environmental hazards. The research project summaries, in narrative outline form, supplied by the individual investigators together with the agenda and other information about the review are presented.

Electron beam processing of fresh produce - A critical review

NASA Astrophysics Data System (ADS)

Pillai, Suresh D.; Shayanfar, Shima

2018-02-01

To meet the increasing global demand for fresh produce, robust processing methods that ensures both the safety and quality of fresh produce are needed. Since fresh produce cannot withstand thermal processing conditions, most of common safety interventions used in other foods are ineffective. Electron beam (eBeam) is a non-thermal technology that can be used to extend the shelf life and ensure the microbiological safety of fresh produce. There have been studies documenting the application of eBeam to ensure both safety and quality in fresh produce, however, there are still unexplored areas that still need further research. This is a critical review on the current literature on the application of eBeam technology for fresh produce.

National Ignition Facility Construction Safety Management Review

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

Warner, B.E.

2000-02-01

An accident occurred at the NIF construction site on January 13, 2000, in which a worker sustained a serious injury when a 42-inch-diameter duct fell during installation. Following the accident, NIF Project Management chartered two review teams: (1) an Incident Analysis Team to independently assess the direct and root causes of the accident, and (2) a Management Review Team to review the roles and responsibilities of the line, support, and construction management organizations involved. This report provides a discussion of the information gathered by the Management Review Team and provides a list of observations and recommendations based on an analysismore » of the information. The Management Review Team includes senior managers who represent several Directorates within LLNL and DOE OAK: Dick Billia representing Engineering; Dave Leary representing Business Services and Public Affairs; Jim Jackson representing Hazards Control; Chuck Taylor representing DOE OAK; Arnie Clobes representing the ICF/NIF Program; and Jon Yatabe and Bruce Warner (Chairperson) representing the NIF Project. The attached letter from the NIF Project Manager, Ed Moses, to the Management Review Team contains the team's Charter. The team was asked to evaluate the effectiveness of the line management and its supporting safety functions in managing safety during NIF construction. The evaluation was to include the current conventional facility construction, which is 85% complete, and upcoming activities such as Beampath Infrastructure System installation, which will begin in the next six months and which represents a significant amount of work over the next two to three years. The remainder of this document describes the Management Review Team's review process (Section 2), its observations gathered during the review (Section 3), and its recommendations to the NIF Project Manager based on those observations (Section 4).« less

Using a 3D CAD plant model to simplify process hazard reviews

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

Tolpa, G.

A Hazard and Operability (HAZOP) review is a formal predictive procedure used to identify potential hazard and operability problems associated with certain processes and facilities. The HAZOP procedure takes place several times during the life cycle of the facility. Replacing plastic models, layout and detail drawings with a 3D CAD electronic model, provides access to process safety information and a detailed level of plant topology that approaches the visualization capability of the imagination. This paper describes the process that is used for adding the use of a 3D CAD model to flowsheets and proven computer programs for the conduct ofmore » hazard and operability reviews. Using flowsheets and study nodes as a road map for the review the need for layout and other detail drawings is all but eliminated. Using the 3D CAD model again for a post-P and ID HAZOP supports conformance to layout and safety requirements, provides superior visualization of the plant configuration and preserves the owners equity in the design. The response from the review teams are overwhelmingly in favor of this type of review over a review that uses only drawings. Over the long term the plant model serves more than just process hazards analysis. Ongoing use of the model can satisfy the required access to process safety information, OHSA documentation and other legal requirements. In this paper extensive instructions address the logic for the process hazards analysis and the preparation required to assist anyone who wishes to add the use of a 3D model to their review.« less

Process safety improvement--quality and target zero.

PubMed

Van Scyoc, Karl

2008-11-15

Process safety practitioners have adopted quality management principles in design of process safety management systems with positive effect, yet achieving safety objectives sometimes remain a distant target. Companies regularly apply tools and methods which have roots in quality and productivity improvement. The "plan, do, check, act" improvement loop, statistical analysis of incidents (non-conformities), and performance trending popularized by Dr. Deming are now commonly used in the context of process safety. Significant advancements in HSE performance are reported after applying methods viewed as fundamental for quality management. In pursuit of continual process safety improvement, the paper examines various quality improvement methods, and explores how methods intended for product quality can be additionally applied to continual improvement of process safety. Methods such as Kaizen, Poke yoke, and TRIZ, while long established for quality improvement, are quite unfamiliar in the process safety arena. These methods are discussed for application in improving both process safety leadership and field work team performance. Practical ways to advance process safety, based on the methods, are given.

Standardized severe maternal morbidity review: rationale and process.

PubMed

Kilpatrick, Sarah J; Berg, Cynthia; Bernstein, Peter; Bingham, Debra; Delgado, Ana; Callaghan, William M; Harris, Karen; Lanni, Susan; Mahoney, Jeanne; Main, Elliot; Nacht, Amy; Schellpfeffer, Michael; Westover, Thomas; Harper, Margaret

2014-08-01

Severe maternal morbidity and mortality have been rising in the United States. To begin a national effort to reduce morbidity, a specific call to identify all pregnant and postpartum women experiencing admission to an intensive care unit or receipt of 4 or more units of blood for routine review has been made. While advocating for review of these cases, no specific guidance for the review process was provided. Therefore, the aim of this expert opinion is to present guidelines for a standardized severe maternal morbidity interdisciplinary review process to identify systems, professional, and facility factors that can be ameliorated, with the overall goal of improving institutional obstetric safety and reducing severe morbidity and mortality among pregnant and recently pregnant women. This opinion was developed by a multidisciplinary working group that included general obstetrician-gynecologists, maternal-fetal medicine subspecialists, certified nurse-midwives, and registered nurses all with experience in maternal mortality reviews. A process for standardized review of severe maternal morbidity addressing committee organization, review process, medical record abstraction and assessment, review culture, data management, review timing, and review confidentiality is presented. Reference is made to a sample severe maternal morbidity abstraction and assessment form.

A literature review of safety culture.

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

Cole, Kerstan Suzanne; Stevens-Adams, Susan Marie; Wenner, Caren A.

2013-03-01

Workplace safety has been historically neglected by organizations in order to enhance profitability. Over the past 30 years, safety concerns and attention to safety have increased due to a series of disastrous events occurring across many different industries (e.g., Chernobyl, Upper Big-Branch Mine, Davis-Besse etc.). Many organizations have focused on promoting a healthy safety culture as a way to understand past incidents, and to prevent future disasters. There is an extensive academic literature devoted to safety culture, and the Department of Energy has also published a significant number of documents related to safety culture. The purpose of the current endeavormore » was to conduct a review of the safety culture literature in order to understand definitions, methodologies, models, and successful interventions for improving safety culture. After reviewing the literature, we observed four emerging themes. First, it was apparent that although safety culture is a valuable construct, it has some inherent weaknesses. For example, there is no common definition of safety culture and no standard way for assessing the construct. Second, it is apparent that researchers know how to measure particular components of safety culture, with specific focus on individual and organizational factors. Such existing methodologies can be leveraged for future assessments. Third, based on the published literature, the relationship between safety culture and performance is tenuous at best. There are few empirical studies that examine the relationship between safety culture and safety performance metrics. Further, most of these studies do not include a description of the implementation of interventions to improve safety culture, or do not measure the effect of these interventions on safety culture or performance. Fourth, safety culture is best viewed as a dynamic, multi-faceted overall system composed of individual, engineered and organizational models. By addressing all three

Obtaining Valid Safety Data for Software Safety Measurement and Process Improvement

NASA Technical Reports Server (NTRS)

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

2010-01-01

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

Medication safety programs in primary care: a scoping review.

PubMed

Khalil, Hanan; Shahid, Monica; Roughead, Libby

2017-10-01

Medication safety plays an essential role in all healthcare organizations; improving this area is paramount to quality and safety of any wider healthcare program. While several medication safety programs in the hospital setting have been described and the associated impact on patient safety evaluated, no systematic reviews have described the impact of medication safety programs in the primary care setting. A preliminary search of the literature demonstrated that no systematic reviews, meta-analysis or scoping reviews have reported on medication safety programs in primary care; instead they have focused on specific interventions such as medication reconciliation or computerized physician order entry. This scoping review sought to map the current medication safety programs used in primary care. The current scoping review sought to examine the characteristics of medication safety programs in the primary care setting and to map evidence on the outcome measures used to assess the effectiveness of medication safety programs in improving patient safety. The current review considered participants of any age and any condition using care obtained from any primary care services. We considered studies that focussed on the characteristics of medication safety programs and the outcome measures used to measure the effectiveness of these programs on patient safety in the primary care setting. The context of this review was primary care settings, primary healthcare organizations, general practitioner clinics, outpatient clinics and any other clinics that do not classify patients as inpatients. We considered all quantitative studied published in English. A three-step search strategy was utilized in this review. Data were extracted from the included studies to address the review question. The data extracted included type of medication safety program, author, country of origin, aims and purpose of the study, study population, method, comparator, context, main findings and outcome

Determinants of safety outcomes and performance: A systematic literature review of research in four high-risk industries.

PubMed

Cornelissen, Pieter A; Van Hoof, Joris J; De Jong, Menno D T

2017-09-01

In spite of increasing governmental and organizational efforts, organizations still struggle to improve the safety of their employees as evidenced by the yearly 2.3 million work-related deaths worldwide. Occupational safety research is scattered and inaccessible, especially for practitioners. Through systematically reviewing the safety literature, this study aims to provide a comprehensive overview of behavioral and circumstantial factors that endanger or support employee safety. A broad search on occupational safety literature using four online bibliographical databases yielded 27.527 articles. Through a systematic reviewing process 176 online articles were identified that met the inclusion criteria (e.g., original peer-reviewed research; conducted in selected high-risk industries; published between 1980-2016). Variables and the nature of their interrelationships (i.e., positive, negative, or nonsignificant) were extracted, and then grouped and classified through a process of bottom-up coding. The results indicate that safety outcomes and performance prevail as dependent research areas, dependent on variables related to management & colleagues, work(place) characteristics & circumstances, employee demographics, climate & culture, and external factors. Consensus was found for five variables related to safety outcomes and seven variables related to performance, while there is debate about 31 other relationships. Last, 21 variables related to safety outcomes and performance appear understudied. The majority of safety research has focused on addressing negative safety outcomes and performance through variables related to others within the organization, the work(place) itself, employee demographics, and-to a lesser extent-climate & culture and external factors. This systematic literature review provides both scientists and safety practitioners an overview of the (under)studied behavioral and circumstantial factors related to occupational safety behavior. Scientists

NASA Post-Columbia Safety & Mission Assurance, Review and Assessment Initiatives

NASA Astrophysics Data System (ADS)

Newman, J. Steven; Wander, Stephen M.; Vecellio, Don; Miller, Andrew J.

2005-12-01

On February 1, 2003, NASA again experienced a tragic accident as the Space Shuttle Columbia broke apart upon reentry, resulting in the loss of seven astronauts. Several of the findings and observations of the Columbia Accident Investigation Board addressed the need to strengthen the safety and mission assurance function at NASA. This paper highlights key steps undertaken by the NASA Office of Safety and Mission Assurance (OSMA) to establish a stronger and more- robust safety and mission assurance function for NASA programs, projects, facilities and operations. This paper provides an overview of the interlocking OSMA Review and Assessment Division (RAD) institutional and programmatic processes designed to 1) educate, inform, and prepare for audits, 2) verify requirements flow-down, 3) verify process capability, 4) verify compliance with requirements, 5) support risk management decision making, 6) facilitate secure web- based collaboration, and 7) foster continual improvement and the use of lessons learned.

Safety Sufficiency for NextGen: Assessment of Selected Existing Safety Methods, Tools, Processes, and Regulations

NASA Technical Reports Server (NTRS)

Xu, Xidong; Ulrey, Mike L.; Brown, John A.; Mast, James; Lapis, Mary B.

2013-01-01

NextGen is a complex socio-technical system and, in many ways, it is expected to be more complex than the current system. It is vital to assess the safety impact of the NextGen elements (technologies, systems, and procedures) in a rigorous and systematic way and to ensure that they do not compromise safety. In this study, the NextGen elements in the form of Operational Improvements (OIs), Enablers, Research Activities, Development Activities, and Policy Issues were identified. The overall hazard situation in NextGen was outlined; a high-level hazard analysis was conducted with respect to multiple elements in a representative NextGen OI known as OI-0349 (Automation Support for Separation Management); and the hazards resulting from the highly dynamic complexity involved in an OI-0349 scenario were illustrated. A selected but representative set of the existing safety methods, tools, processes, and regulations was then reviewed and analyzed regarding whether they are sufficient to assess safety in the elements of that OI and ensure that safety will not be compromised and whether they might incur intolerably high costs.

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...

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

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

Browne, E.T.

1981-03-01

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

A review of models relevant to road safety.

PubMed

Hughes, B P; Newstead, S; Anund, A; Shu, C C; Falkmer, T

2015-01-01

It is estimated that more than 1.2 million people die worldwide as a result of road traffic crashes and some 50 million are injured per annum. At present some Western countries' road safety strategies and countermeasures claim to have developed into 'Safe Systems' models to address the effects of road related crashes. Well-constructed models encourage effective strategies to improve road safety. This review aimed to identify and summarise concise descriptions, or 'models' of safety. The review covers information from a wide variety of fields and contexts including transport, occupational safety, food industry, education, construction and health. The information from 2620 candidate references were selected and summarised in 121 examples of different types of model and contents. The language of safety models and systems was found to be inconsistent. Each model provided additional information regarding style, purpose, complexity and diversity. In total, seven types of models were identified. The categorisation of models was done on a high level with a variation of details in each group and without a complete, simple and rational description. The models identified in this review are likely to be adaptable to road safety and some of them have previously been used. None of systems theory, safety management systems, the risk management approach, or safety culture was commonly or thoroughly applied to road safety. It is concluded that these approaches have the potential to reduce road trauma. Copyright © 2014 Elsevier Ltd. All rights reserved.

Safety Education Impact and Good Practice: A Review

ERIC Educational Resources Information Center

Mulvaney, Caroline A.; Watson, Michael C.; Errington, Gail

2012-01-01

Purpose: The aim of this literature review was to examine recent evidence of the impact of safety education for children and young people on unintentional injury rates and to update an earlier review. Evidence was sought that linked safety education for children and young people in schools, centres and other settings with changes in knowledge,…

School Safety Review Checklist

ERIC Educational Resources Information Center

Vermont Department of Education, 2005

2005-01-01

The School Safety Review Checklist is an important component of the broader school crisis resources that have been developed by the Vermont School Crisis Planning Team. The Team is comprised of members from the law enforcement, emergency management, health, and education organizations who have worked throughout the year to update school and…

A systematic review of patient safety in mental health: a protocol based on the inpatient setting.

PubMed

D'Lima, Danielle; Archer, Stephanie; Thibaut, Bethan Ines; Ramtale, Sonny Christian; Dewa, Lindsay H; Darzi, Ara

2016-11-29

Despite the growing international interest in patient safety as a discipline, there has been a lack of exploration of its application to mental health. It cannot be assumed that findings based upon physical health in acute care hospitals can be applied to mental health patients, disorders and settings. To the authors' knowledge, there has only been one review of the literature that focuses on patient safety research in mental health settings, conducted in Canada in 2008. We have identified a need to update this review and develop the methodology in order to strengthen the findings and disseminate internationally for advancement in the field. This systematic review will explore the existing research base on patient safety in mental health within the inpatient setting. To conduct this systematic review, a thorough search across multiple databases will be undertaken, based upon four search facets ("mental health", "patient safety", "research" and "inpatient setting"). The search strategy has been developed based upon the Canadian review accompanied with input from the National Reporting and Learning System (NRLS) taxonomy of patient safety incidents and the Diagnostic and Statistical Manual of Mental Disorders (fifth edition). The screening process will involve perspectives from at least two researchers at all stages with a third researcher invited to review when discrepancies require resolution. Initial inclusion and exclusion criteria have been developed and will be refined iteratively throughout the process. Quality assessment and data extraction of included articles will be conducted by at least two researchers. A data extraction form will be developed, piloted and iterated as necessary in accordance with the research question. Extracted information will be analysed thematically. We believe that this systematic review will make a significant contribution to the advancement of patient safety in mental health inpatient settings. The findings will enable the

Occupational Safety Review of High Technology Facilities

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

Lee Cadwallader

2005-01-31

This report contains reviews of operating experiences, selected accident events, and industrial safety performance indicators that document the performance of the major US DOE magnetic fusion experiments and particle accelerators. These data are useful to form a basis for the occupational safety level at matured research facilities with known sets of safety rules and regulations. Some of the issues discussed are radiation safety, electromagnetic energy exposure events, and some of the more widespread issues of working at height, equipment fires, confined space work, electrical work, and other industrial hazards. Nuclear power plant industrial safety data are also included for comparison.

Safety Review Panel (SRP) Special Topic Presentation on the Iodine Compatible Water Container (ICWC)

NASA Technical Reports Server (NTRS)

Thomas, Evan A.

2008-01-01

This viewgraph presentation reviews the safety requirements for the Iodine Compatible Water Container (ICWC). The topics include: 1) ICWC Team; 2) Purpose of presentation; 3) Background/Description of ICWC System; 4) Current status of ICWC Project; 5) HTV launch NCR Processing; 6) Tox 1 containment NCR processing; and 7) ISS on-orbit failure propagation and fault tolerance NCR processing.

Adapting viral safety assurance strategies to continuous processing of biological products.

PubMed

Johnson, Sarah A; Brown, Matthew R; Lute, Scott C; Brorson, Kurt A

2017-01-01

There has been a recent drive in commercial large-scale production of biotechnology products to convert current batch mode processing to continuous processing manufacturing. There have been reports of model systems capable of adapting and linking upstream and downstream technologies into a continuous manufacturing pipeline. However, in many of these proposed continuous processing model systems, viral safety has not been comprehensively addressed. Viral safety and detection is a highly important and often expensive regulatory requirement for any new biological product. To ensure success in the adaption of continuous processing to large-scale production, there is a need to consider the development of approaches that allow for seamless incorporation of viral testing and clearance/inactivation methods. In this review, we outline potential strategies to apply current viral testing and clearance/inactivation technologies to continuous processing, as well as modifications of existing unit operations to ensure the successful integration of viral clearance into the continuous processing of biological products. Biotechnol. Bioeng. 2017;114: 21-32. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Safety Behaviors in Adults With Social Anxiety: Review and Future Directions.

PubMed

Piccirillo, Marilyn L; Taylor Dryman, M; Heimberg, Richard G

2016-09-01

Safety behaviors are considered an important factor in the maintenance of social anxiety disorder (SAD). Safety behaviors are typically employed by socially anxious individuals to reduce anxiety in feared social situations. However, by preventing individuals with social anxiety from gathering evidence that would disconfirm their maladaptive beliefs about social situations, the use of safety behaviors ultimately maintains social anxiety over time. Twenty years ago, Wells and colleagues (1995) demonstrated that use of safety behaviors diminishes the efficacy of exposure treatment for SAD, suggesting that reduction in the use of safety behaviors during exposure can enhance treatment response. Research on safety behaviors has expanded considerably since Wells et al.'s seminal publication, and our understanding of the role safety behaviors may play in the maintenance of social anxiety has grown in breadth and depth. In this paper, we present a detailed review of the published research on safety behaviors relevant to social anxiety and social-anxiety-related processes. Finally, we evaluate the impact of safety behaviors on the outcome of treatment for SAD, and we look to the literature on safety behaviors in other anxiety disorders to inform our understanding of use of safety behaviors during exposure and to facilitate future research in SAD. Copyright © 2015. Published by Elsevier Ltd.

10 CFR 830.203 - Unreviewed safety question process.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Unreviewed safety question process. 830.203 Section 830.203 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.203 Unreviewed safety question process. (a) The contractor responsible for a hazard category 1, 2, or 3 DOE...

Using systematic review in occupational safety and health.

PubMed

Howard, John; Piacentino, John; MacMahon, Kathleen; Schulte, Paul

2017-11-01

Evaluation of scientific evidence is critical in developing recommendations to reduce risk. Healthcare was the first scientific field to employ a systematic review approach for synthesizing research findings to support evidence-based decision-making and it is still the largest producer and consumer of systematic reviews. Systematic reviews in the field of occupational safety and health are being conducted, but more widespread use and adoption would strengthen assessments. In 2016, NIOSH asked RAND to develop a framework for applying the traditional systematic review elements to the field of occupational safety and health. This paper describes how essential systematic review elements can be adapted for use in occupational systematic reviews to enhance their scientific quality, objectivity, transparency, reliability, utility, and acceptability. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

Translating New Science Into the Drug Review Process

PubMed Central

Rouse, Rodney; Kruhlak, Naomi; Weaver, James; Burkhart, Keith; Patel, Vikram; Strauss, David G.

2017-01-01

In 2011, the US Food and drug Administration (FDA) developed a strategic plan for regulatory science that focuses on developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. In line with this, the Division of Applied Regulatory Science was created to move new science into the Center for Drug Evaluation and Research (CDER) review process and close the gap between scientific innovation and drug review. The Division, located in the Office of Clinical Pharmacology, is unique in that it performs mission-critical applied research and review across the translational research spectrum including in vitro and in vivo laboratory research, in silico computational modeling and informatics, and integrated clinical research covering clinical pharmacology, experimental medicine, and postmarket analyses. The Division collaborates with Offices throughout CDER, across the FDA, other government agencies, academia, and industry. The Division is able to rapidly form interdisciplinary teams of pharmacologists, biologists, chemists, computational scientists, and clinicians to respond to challenging regulatory questions for specific review issues and for longer-range projects requiring the development of predictive models, tools, and biomarkers to speed the development and regulatory evaluation of safe and effective drugs. This article reviews the Division’s recent work and future directions, highlighting development and validation of biomarkers; novel humanized animal models; translational predictive safety combining in vitro, in silico, and in vivo clinical biomarkers; chemical and biomedical informatics tools for safety predictions; novel approaches to speed the development of complex generic drugs, biosimilars, and antibiotics; and precision medicine. PMID:29568713

HFE safety reviews of advanced nuclear power plant control rooms

NASA Technical Reports Server (NTRS)

Ohara, John

1994-01-01

Advanced control rooms (ACR's) will utilize human-system interface (HSI) technologies that may have significant implications for plant safety in that they will affect the operator's overall role and means of interacting with the system. The Nuclear Regulatory Commission (NRC) reviews the human factors engineering (HFE) aspects of HSI's to ensure that they are designed to good HFE principles and support performance and reliability in order to protect public health and safety. However, the only available NRC guidance was developed more than ten years ago, and does not adequately address the human performance issues and technology changes associated with ACR's. Accordingly, a new approach to ACR safety reviews was developed based upon the concept of 'convergent validity'. This approach to ACR safety reviews is described.

Discretionary Review by the Occupational Safety and Health Review Commission: Is It Necessary?

ERIC Educational Resources Information Center

Moran, Robert D.

1974-01-01

Deficiencies in the Occupational Safety and Health Review Commission (OSAHRC), a court system created to carry out adjudicatory functions under the Williams-Steiger Occupational Safety and Health Act of 1970, are exposed and alternative solutions offered. (JT)

IRQN award paper: Operational rounds: a practical administrative process to improve safety and clinical services in radiology.

PubMed

Donnelly, Lane F; Dickerson, Julie M; Lehkamp, Todd W; Gessner, Kevin E; Moskovitz, Jay; Hutchinson, Sally

2008-11-01

As part of a patient safety program in the authors' department of radiology, operational rounds have been instituted. This process consists of radiology leaders' visiting imaging divisions at the site of imaging and discussing frontline employees' concerns about patient safety, the quality of care, and patient and family satisfaction. Operational rounds are executed at a time to optimize the number of attendees. Minutes that describe the issues identified, persons responsible for improvement, and updated improvement plan status are available to employees online. Via this process, multiple patient safety and other issues have been identified and remedied. The authors believe that the process has improved patient safety, the quality of care, and the efficiency of operations. Since the inception of the safety program, the mean number of days between serious safety events involving radiology has doubled. The authors review the background around such walk rounds, describe their particular program, and give multiple illustrative examples of issues identified and improvement plans put in place.

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

49 CFR 659.27 - Internal safety and security reviews.

Code of Federal Regulations, 2010 CFR

2010-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the..., indicating that the rail transit agency is in compliance with its system safety program plan and system... security reviews indicate that the rail transit agency is not in compliance with its system safety program...

Leadership, safety climate, and continuous quality improvement: impact on process quality and patient safety.

PubMed

McFadden, Kathleen L; Stock, Gregory N; Gowen, Charles R

2014-10-01

Successful amelioration of medical errors represents a significant problem in the health care industry. There is a need for greater understanding of the factors that lead to improved process quality and patient safety outcomes in hospitals. We present a research model that shows how transformational leadership, safety climate, and continuous quality improvement (CQI) initiatives are related to objective quality and patient safety outcome measures. The proposed framework is tested using structural equation modeling, based on data collected for 204 hospitals, and supplemented with objective outcome data from the Centers for Medicare and Medicaid Services. The results provide empirical evidence that a safety climate, which is connected to the chief executive officer's transformational leadership style, is related to CQI initiatives, which are linked to improved process quality. A unique finding of this study is that, although CQI initiatives are positively associated with improved process quality, they are also associated with higher hospital-acquired condition rates, a measure of patient safety. Likewise, safety climate is directly related to improved patient safety outcomes. The notion that patient safety climate and CQI initiatives are not interchangeable or universally beneficial is an important contribution to the literature. The results confirm the importance of using CQI to effectively enhance process quality in hospitals, and patient safety climate to improve patient safety outcomes. The overall pattern of findings suggests that simultaneous implementation of CQI initiatives and patient safety climate produces greater combined benefits.

Leadership, safety climate, and continuous quality improvement: impact on process quality and patient safety.

PubMed

McFadden, Kathleen L; Stock, Gregory N; Gowen, Charles R

2015-01-01

Successful amelioration of medical errors represents a significant problem in the health care industry. There is a need for greater understanding of the factors that lead to improved process quality and patient safety outcomes in hospitals. We present a research model that shows how transformational leadership, safety climate, and continuous quality improvement (CQI) initiatives are related to objective quality and patient safety outcome measures. The proposed framework is tested using structural equation modeling, based on data collected for 204 hospitals, and supplemented with objective outcome data from the Centers for Medicare and Medicaid Services. The results provide empirical evidence that a safety climate, which is connected to the chief executive officer's transformational leadership style, is related to CQI initiatives, which are linked to improved process quality. A unique finding of this study is that, although CQI initiatives are positively associated with improved process quality, they are also associated with higher hospital-acquired condition rates, a measure of patient safety. Likewise, safety climate is directly related to improved patient safety outcomes. The notion that patient safety climate and CQI initiatives are not interchangeable or universally beneficial is an important contribution to the literature. The results confirm the importance of using CQI to effectively enhance process quality in hospitals, and patient safety climate to improve patient safety outcomes. The overall pattern of findings suggests that simultaneous implementation of CQI initiatives and patient safety climate produces greater combined benefits.

Nonthermal processing technologies as food safety intervention processes

USDA-ARS?s Scientific Manuscript database

Foods should provide sensorial satisfaction and nutrition to people. Yet, foodborne pathogens cause significant illness and lose of life to human kind every year. A processing intervention step may be necessary prior to the consumption to ensure the safety of foods. Nonthermal processing technologi...

14 CFR 414.19 - Technical criteria for reviewing a safety approval application.

Code of Federal Regulations, 2011 CFR

2011-01-01

...-developed criteria must define— (i) Design and minimum performance; (ii) Quality assurance system... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Technical criteria for reviewing a safety... AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING SAFETY APPROVALS Safety Approval Review and...

Experiments To Demonstrate Chemical Process Safety Principles.

ERIC Educational Resources Information Center

Dorathy, Brian D.; Mooers, Jamisue A.; Warren, Matthew M.; Mich, Jennifer L.; Murhammer, David W.

2001-01-01

Points out the need to educate undergraduate chemical engineering students on chemical process safety and introduces the content of a chemical process safety course offered at the University of Iowa. Presents laboratory experiments demonstrating flammability limits, flash points, electrostatic, runaway reactions, explosions, and relief design.…

TOY SAFETY SURVEILLANCE FROM ONLINE REVIEWS

PubMed Central

Winkler, Matt; Abrahams, Alan S.; Gruss, Richard; Ehsani, Johnathan P.

2016-01-01

Toy-related injuries account for a significant number of childhood injuries and the prevention of these injuries remains a goal for regulatory agencies and manufacturers. Text-mining is an increasingly prevalent method for uncovering the significance of words using big data. This research sets out to determine the effectiveness of text-mining in uncovering potentially dangerous children’s toys. We develop a danger word list, also known as a ‘smoke word’ list, from injury and recall text narratives. We then use the smoke word lists to score over one million Amazon reviews, with the top scores denoting potential safety concerns. We compare the smoke word list to conventional sentiment analysis techniques, in terms of both word overlap and effectiveness. We find that smoke word lists are highly distinct from conventional sentiment dictionaries and provide a statistically significant method for identifying safety concerns in children’s toy reviews. Our findings indicate that text-mining is, in fact, an effective method for the surveillance of safety concerns in children’s toys and could be a gateway to effective prevention of toy-product-related injuries. PMID:27942092

Clinical perspective: creating an effective practice peer review process-a primer.

PubMed

Gandhi, Manisha; Louis, Frances S; Wilson, Shae H; Clark, Steven L

2017-03-01

Peer review serves as an important adjunct to other hospital quality and safety programs. Despite its importance, the available literature contains virtually no guidance regarding the structure and function of effective peer review committees. This Clinical Perspective provides a summary of the purposes, structure, and functioning of effective peer review committees. We also discuss important legal considerations that are a necessary component of such processes. This discussion includes useful templates for case selection and review. Proper committee structure, membership, work flow, and leadership as well as close cooperation with the hospital medical executive committee and legal representatives are essential to any effective peer review process. A thoughtful, fair, systematic, and organized approach to creating a peer review process will lead to confidence in the committee by providers, hospital leadership, and patients. If properly constructed, such committees may also assist in monitoring and enforcing compliance with departmental protocols, thus reducing harm and promoting high-quality practice. Copyright © 2016 Elsevier Inc. All rights reserved.

Narrative review of the UK Patient Safety Research Portfolio.

PubMed

Waring, Justin; Rowley, Emma; Dingwall, Robert; Palmer, Cecily; Murcott, Toby

2010-01-01

The UK Patient Safety Research Portfolio (PSRP) commissioned 38 studies investigating the threats to patient safety in various clinical settings and evaluating safety-related service interventions. This paper reviews 27 of these studies, drawing out emergent and cross-cutting themes in terms of theory, research methods and thematic findings. Given the diversity of PSRP studies, the paper takes a narrative approach that allows for qualitative description, interpretation and synthesis of the studies and their findings. The theoretical review shows the majority of PSRP studies draw upon a patient safety 'orthodoxy', developed from the concepts and models associated with the human factors approach. The methodological review shows that a diverse range of research designs and techniques have been utilized. Although many follow in the 'scientific' tradition, interpretative, mixed and innovative methods have been integral to research. The thematic review of findings highlights significant contributions to knowledge in the areas of 'people', 'organizations', and 'technology'. As well as identifying the various sources of risk in the organization and delivery of patient care, the studies also evaluate and make recommendations about service change and improvement. The PSRP has provided the foundations for significant theoretical, methodological and empirical advances in the area of patient safety. The findings and recommendations make important contributions to policy formulation and implementation as well as professional and managerial practice. Through this body of research the PSRP has supported the formation and growth of a thriving research community across academic, policy and professional communities.

Status of patient safety culture in Arab countries: a systematic review

PubMed Central

Almashrafi, Ahmed; Banarsee, Ricky

2017-01-01

Objectives To explore the status of patient safety culture in Arab countries based on the findings of the Hospital Survey on Patient Safety Culture (HSPSC). Design Systematic review. Methods We performed electronic searches of the MEDLINE, EMBASE, CINAHL, ProQuest and PsychINFO, Google Scholar and PubMed databases, with manual searches of bibliographies of included articles and key journals. We included studies that were conducted in the Arab countries that were focused on patient safety culture. 2 reviewers independently verified that the studies met the inclusion criteria and critically assessed the quality of the studies. Results 18 studies met our inclusion criteria. The review identified that non-punitive response to error is seen as a serious issue which needs to be improved. Healthcare professionals in the Arab countries tend to think that a ‘culture of blame’ still exists that prevents them from reporting incidents. We found an overall similarity between the reported composite score for dimension of teamwork within units in all of the reviewed studies. Teamwork within units was found to be better than teamwork across hospital units. All of the reviewed studies reported that organisational learning and continuous improvement was satisfactory as the average score of this dimension for all studies was 73.2%. Moreover, the review found that communication openness seems to be a concerning issue for healthcare professionals in the Arab countries. Conclusions There is a need to promote patient safety culture as a strategy for improving the patient safety in the Arab world. Improving patient safety culture should include all stakeholders, like policymakers, healthcare providers and those responsible for medical education. This review was limited only to English language publications. The varied settings in which the HSPSC was used may have influenced the areas of strengths and weaknesses as healthcare workers' perception of safety culture may differ. PMID

Natural Language Processing and Its Implications for the Future of Medication Safety: A Narrative Review of Recent Advances and Challenges.

PubMed

Wong, Adrian; Plasek, Joseph M; Montecalvo, Steven P; Zhou, Li

2018-06-09

The safety of medication use has been a priority in the United States since the late 1930s. Recently, it has gained prominence due to the increasing amount of data suggesting that a large amount of patient harm is preventable and can be mitigated with effective risk strategies that have not been sufficiently adopted. Adverse events from medications are part of clinical practice, but the ability to identify a patient's risk and to minimize that risk must be a priority. The ability to identify adverse events has been a challenge due to limitations of available data sources, which are often free text. The use of natural language processing (NLP) may help to address these limitations. NLP is the artificial intelligence domain of computer science that uses computers to manipulate unstructured data (i.e., narrative text or speech data) in the context of a specific task. In this narrative review, we illustrate the fundamentals of NLP and discuss NLP's application to medication safety in four data sources: electronic health records, Internet-based data, published literature, and reporting systems. Given the magnitude of available data from these sources, a growing area is the use of computer algorithms to help automatically detect associations between medications and adverse effects. The main benefit of NLP is in the time savings associated with automation of various medication safety tasks such as the medication reconciliation process facilitated by computers, as well as the potential for near-real time identification of adverse events for postmarketing surveillance such as those posted on social media that would otherwise go unanalyzed. NLP is limited by a lack of data sharing between health care organizations due to insufficient interoperability capabilities, inhibiting large-scale adverse event monitoring across populations. We anticipate that future work in this area will focus on the integration of data sources from different domains to improve the ability to

Updating Human Factors Engineering Guidelines for Conducting Safety Reviews of Nuclear Power Plants

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

O, J.M.; Higgins, J.; Stephen Fleger - NRC

The U.S. Nuclear Regulatory Commission (NRC) reviews the human factors engineering (HFE) programs of applicants for nuclear power plant construction permits, operating licenses, standard design certifications, and combined operating licenses. The purpose of these safety reviews is to help ensure that personnel performance and reliability are appropriately supported. Detailed design review procedures and guidance for the evaluations is provided in three key documents: the Standard Review Plan (NUREG-0800), the HFE Program Review Model (NUREG-0711), and the Human-System Interface Design Review Guidelines (NUREG-0700). These documents were last revised in 2007, 2004 and 2002, respectively. The NRC is committed to the periodicmore » update and improvement of the guidance to ensure that it remains a state-of-the-art design evaluation tool. To this end, the NRC is updating its guidance to stay current with recent research on human performance, advances in HFE methods and tools, and new technology being employed in plant and control room design. This paper describes the role of HFE guidelines in the safety review process and the content of the key HFE guidelines used. Then we will present the methodology used to develop HFE guidance and update these documents, and describe the current status of the update program.« less

Review of BART "C" Car Fire Safety Characteristics

DOT National Transportation Integrated Search

1987-09-01

The report presents the results of a review of the fire safety characteristics of the prototype BART "C" Car. Initiated in response to a request from the Urban Mass Transportation Administration (UMTA) Region IX Administrator, the review has been str...

Delivering on the Promise of CLER: A Patient Safety Rotation That Aligns Resident Education With Hospital Processes.

PubMed

Patel, Ekta; Muthusamy, Veena; Young, John Q

2018-06-01

Residency programs must provide training in patient safety. Yet, significant gaps exist among published patient safety curricula. The authors developed a rotation designed to be scalable to an entire residency, built on sound pedagogy, aligned with hospital safety processes, and effective in improving educational outcomes. From July 2015 to May 2017, each second-year resident completed the two-week rotation. Residents engaged the foundational science asynchronously via multiple modalities and then practiced applying key concepts during a mock root cause analysis. Next, each resident performed a special review of an actual adverse patient event and presented findings to the hospital's Special Review Committee (SRC). Multiple educational outcomes were assessed, including resident satisfaction and attitudes (postrotation survey), changes in knowledge via pre- and posttest, quality of the residents' written safety analyses and oral presentations (per survey of SRC members), and organizational changes that resulted from the residents' reviews. Twenty-two residents completed the rotation. Most components were rated favorably; 80% (12/15 respondents) indicated interest in future patient safety work. Knowledge improved by 44.3% (P < .0001; pretest mean 23.7, posttest mean 34.2). Compared to faculty, SRC members rated the quality of residents' written reviews as superior and the quality of the rated oral presentations as either comparable or superior. The reviews identified a variety of safety vulnerabilities and led to multiple corrective actions. The authors will evaluate the curriculum in a controlled trial with better measures of change in behavior. Further tests of the curriculum's scalability to other contexts are needed.

Description and Yield of Current Quality and Safety Review in Selected US Academic Emergency Departments.

PubMed

Griffey, Richard Thomas; Schneider, Ryan M; Sharp, Brian R; Pothof, Jeffrey J; Hodkins, Sheridan; Capp, Roberta; Wiler, Jennifer L; Sreshta, Neil; Sather, John E; Sampson, Christopher S; Powell, Jonathan T; Groner, Kathryn Y; Adler, Lee M

2017-06-29

Quality and safety review for performance improvement is important for systems of care and is required for US academic emergency departments (EDs). Assessment of the impact of patient safety initiatives in the context of increasing burdens of quality measurement compels standardized, meaningful, high-yield approaches for performance review. Limited data describe how quality and safety reviews are currently conducted and how well they perform in detecting patient harm and areas for improvement. We hypothesized that decades-old approaches used in many academic EDs are inefficient and low yield for identifying patient harm. We conducted a prospective observational study to evaluate the efficiency and yield of current quality review processes at five academic EDs for a 12-month period. Sites provided descriptions of their current practice and collected summary data on the number and severity of events identified in their reviews and the referral sources that led to their capture. Categories of common referral sources were established at the beginning of the study. Sites used the Institute for Healthcare Improvement's definition in defining an adverse event and a modified National Coordinating Council for Medication Error Reporting and Prevention (MERP) Index for grading severity of events. Participating sites had similar processes for quality review, including a two-level review process, monthly reviews and conferences, similar screening criteria, and a grading system for evaluating cases. In 60 months of data collection, we reviewed a total of 4735 cases and identified 381 events. This included 287 near-misses, errors/events (MERP A-I) and 94 adverse events (AEs) (MERP E-I). The overall AE rate (event rate with harm) was 1.99 (95% confidence interval = 1.62%-2.43%), ranging from 1.24% to 3.47% across sites. The overall rate of quality concerns (events without harm) was 6.06% (5.42%-6.78%), ranging from 2.96% to 10.95% across sites. Seventy-two-hour returns were the

Food safety management systems performance in African food processing companies: a review of deficiencies and possible improvement strategies.

PubMed

Kussaga, Jamal B; Jacxsens, Liesbeth; Tiisekwa, Bendantunguka Pm; Luning, Pieternel A

2014-08-01

This study seeks to provide insight into current deficiencies in food safety management systems (FSMS) in African food-processing companies and to identify possible strategies for improvement so as to contribute to African countries' efforts to provide safe food to both local and international markets. This study found that most African food products had high microbiological and chemical contamination levels exceeding the set (legal) limits. Relative to industrialized countries, the study identified various deficiencies at government, sector/branch, retail and company levels which affect performance of FSMS in Africa. For instance, very few companies (except exporting and large companies) have implemented HACCP and ISO 22000:2005. Various measures were proposed to be taken at government (e.g. construction of risk-based legislative frameworks, strengthening of food safety authorities, recommend use of ISO 22000:2005, and consumers' food safety training), branch/sector (e.g. sector-specific guidelines and third-party certification), retail (develop stringent certification standards and impose product specifications) and company levels (improving hygiene, strict raw material control, production process efficacy, and enhancing monitoring systems, assurance activities and supportive administrative structures). By working on those four levels, FSMS of African food-processing companies could be better designed and tailored towards their production processes and specific needs to ensure food safety. © 2014 Society of Chemical Industry.

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

Healthcare Staff Wellbeing, Burnout, and Patient Safety: A Systematic Review

PubMed Central

Hall, Louise H.; Johnson, Judith; Watt, Ian; Tsipa, Anastasia; O’Connor, Daryl B.

2016-01-01

Objective To determine whether there is an association between healthcare professionals’ wellbeing and burnout, with patient safety. Design Systematic research review. Data Sources PsychInfo (1806 to July 2015), Medline (1946 to July 2015), Embase (1947 to July 2015) and Scopus (1823 to July 2015) were searched, along with reference lists of eligible articles. Eligibility Criteria for Selecting Studies Quantitative, empirical studies that included i) either a measure of wellbeing or burnout, and ii) patient safety, in healthcare staff populations. Results Forty-six studies were identified. Sixteen out of the 27 studies that measured wellbeing found a significant correlation between poor wellbeing and worse patient safety, with six additional studies finding an association with some but not all scales used, and one study finding a significant association but in the opposite direction to the majority of studies. Twenty-one out of the 30 studies that measured burnout found a significant association between burnout and patient safety, whilst a further four studies found an association between one or more (but not all) subscales of the burnout measures employed, and patient safety. Conclusions Poor wellbeing and moderate to high levels of burnout are associated, in the majority of studies reviewed, with poor patient safety outcomes such as medical errors, however the lack of prospective studies reduces the ability to determine causality. Further prospective studies, research in primary care, conducted within the UK, and a clearer definition of healthcare staff wellbeing are needed. Implications This review illustrates the need for healthcare organisations to consider improving employees’ mental health as well as creating safer work environments when planning interventions to improve patient safety. Systematic Review Registration PROSPERO registration number: CRD42015023340. PMID:27391946

[Should we establish patient safety leadership walkrounds? A systematic review].

PubMed

Girerd-Genessay, I; Michel, P

2015-10-01

Used for over a decade, patient safety leadership walkrounds (PSLWs) is a managerial method designed to enhance the implementation of safety measures in hospitals. In order to determine the effect of PSLWs in French hospitals, we reviewed the literature on participant perceptions and the impact of PSLW on the overall culture of safety. We conducted a systematic review of articles assessing the impact of PSLWs on the culture of safety (comparative studies) or the perceptions of caregivers and managers (qualitative studies). Five studies investigating safety culture and three studies investigating participant perception were identified. PSLWs were associated with an improvement in safety culture and the overall safety climate. The presence of caregivers during the PSLWs was important to achieve improvement. PSLWs improved the dialogue between caregivers and managers, and improved knowledge on care safety. Some problems concerning managerial PSLW attendance and counter-productive attitudes have occasionally been reported. PSLWs improve safety culture. Their effectiveness depends on the way they are implemented. They should initially be tested in France to ensure their feasibility and acceptability in our healthcare system. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Inhibition of Fear by Learned Safety Signals: minisymposium review

PubMed Central

Fernando, Anushka B. P.; Kazama, Andy M.; Jovanovic, Tanja; Ostroff, Linnaea E.; Sangha, Susan

2012-01-01

Safety signals are learned cues that predict the non-occurrence of an aversive event. As such, safety signals are potent inhibitors of fear and stress responses. Investigations of safety signal learning have increased over the last few years due in part to the finding that traumatized persons are unable to utilize safety cues to inhibit fear, making it a clinically relevant phenotype. The goal of this review is to present recent advances relating to the neural and behavioral mechanisms of safety learning and expression in rodents, non-human primates and humans. PMID:23055481

Quo Vadis Payload Safety?

NASA Technical Reports Server (NTRS)

Fodroci, Michael P.; Schwartz, MaryBeth

2008-01-01

As we complete the preparations for the fourth Hubble Space Telescope (HST) servicing mission, we note an anniversary approaching: it was 30 years ago in July that the first HST payload safety review panel meeting was held. This, in turn, was just over a year after the very first payload safety review, a Phase 0 review for the Tracking and Data Relay Satellite and its Inertial Upper Stage, held in June of 1977. In adapting a process that had been used in the review and certification of earlier Skylab payloads, National Aeronautics and Space Administration (NASA) engineers sought to preserve the lessons learned in the development of technical payload safety requirements, while creating a new process that would serve the very different needs of the new space shuttle program. Their success in this undertaking is substantiated by the fact that this process and these requirements have proven to be remarkably robust, flexible, and adaptable. Furthermore, the payload safety process has, to date, served us well in the critical mission of safeguarding our astronauts, cosmonauts, and spaceflight participants. Both the technical requirements and their interpretation, as well as the associated process requirements have grown, evolved, been streamlined, and have been adapted to fit multiple programs, including the International Space Station (ISS) program, the Shuttle/Mir program, and most recently the United States Constellation program. From its earliest days, it was anticipated that the payload safety process would be international in scope, and so it has been. European Space Agency (ESA), Japan Aerospace Exploration Agency (JAXA), German Space Agency (DLR), Canadian Space Agency (CSA), Russian Space Agency (RSA), and many additional countries have flown payloads on both the space shuttle and on the ISS. Our close cooperation and long-term working relationships have culminated in the franchising of the payload safety review process itself to our partners in ESA, which in

Economic evaluation in patient safety: a literature review of methods.

PubMed

de Rezende, Bruna Alves; Or, Zeynep; Com-Ruelle, Laure; Michel, Philippe

2012-06-01

Patient safety practices, targeting organisational changes for improving patient safety, are implemented worldwide but their costs are rarely evaluated. This paper provides a review of the methods used in economic evaluation of such practices. International medical and economics databases were searched for peer-reviewed publications on economic evaluations of patient safety between 2000 and 2010 in English and French. This was complemented by a manual search of the reference lists of relevant papers. Grey literature was excluded. Studies were described using a standardised template and assessed independently by two researchers according to six quality criteria. 33 articles were reviewed that were representative of different patient safety domains, data types and evaluation methods. 18 estimated the economic burden of adverse events, 3 measured the costs of patient safety practices and 12 provided complete economic evaluations. Healthcare-associated infections were the most common subject of evaluation, followed by medication-related errors and all types of adverse events. Of these, 10 were selected that had adequately fulfilled one or several key quality criteria for illustration. This review shows that full cost-benefit/utility evaluations are rarely completed as they are resource intensive and often require unavailable data; some overcome these difficulties by performing stochastic modelling and by using secondary sources. Low methodological transparency can be a problem for building evidence from available economic evaluations. Investing in the economic design and reporting of studies with more emphasis on defining study perspectives, data collection and methodological choices could be helpful for strengthening our knowledge base on practices for improving patient safety.

SRTC criticality safety technical review: Nuclear Criticality Safety Evaluation 93-04 enriched uranium receipt

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

Rathbun, R.

Review of NMP-NCS-930087, {open_quotes}Nuclear Criticality Safety Evaluation 93-04 Enriched Uranium Receipt (U), July 30, 1993, {close_quotes} was requested of SRTC (Savannah River Technology Center) Applied Physics Group. The NCSE is a criticality assessment to determine the mass limit for Engineered Low Level Trench (ELLT) waste uranium burial. The intent is to bury uranium in pits that would be separated by a specified amount of undisturbed soil. The scope of the technical review, documented in this report, consisted of (1) an independent check of the methods and models employed, (2) independent HRXN/KENO-V.a calculations of alternate configurations, (3) application of ANSI/ANS 8.1,more » and (4) verification of WSRC Nuclear Criticality Safety Manual procedures. The NCSE under review concludes that a 500 gram limit per burial position is acceptable to ensure the burial site remains in a critically safe configuration for all normal and single credible abnormal conditions. This reviewer agrees with that conclusion.« less

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 8 2011-10-01 2011-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 8 2013-10-01 2013-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 8 2014-10-01 2014-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 8 2012-10-01 2012-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

49 CFR 1106.4 - The Safety Integration Plan process.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 8 2010-10-01 2010-10-01 false The Safety Integration Plan process. 1106.4... CONSIDERATION OF SAFETY INTEGRATION PLANS IN CASES INVOLVING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL § 1106.4 The Safety Integration Plan process. (a) Each applicant in a transaction subject...

Launch Services Safety Overview

NASA Technical Reports Server (NTRS)

Loftin, Charles E.

2008-01-01

NASA/KSC Launch Services Division Safety (SA-D) services include: (1) Assessing the safety of the launch vehicle (2) Assessing the safety of NASA ELV spacecraft (S/C) / launch vehicle (LV) interfaces (3) Assessing the safety of spacecraft processing to ensure resource protection of: - KSC facilities - KSC VAFB facilities - KSC controlled property - Other NASA assets (4) NASA personnel safety (5) Interfacing with payload organizations to review spacecraft for adequate safety implementation and compliance for integrated activities (6) Assisting in the integration of safety activities between the payload, launch vehicle, and processing facilities

29 CFR 2200.108 - Official Seal of the Occupational Safety and Health Review Commission.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 29 Labor 9 2014-07-01 2014-07-01 false Official Seal of the Occupational Safety and Health Review... Occupational Safety and Health Review Commission. The seal of the Commission shall consist of: A gold eagle... background, encircled by a white band edged in black and inscribed “Occupational Safety and Health Review...

29 CFR 2200.108 - Official Seal of the Occupational Safety and Health Review Commission.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 29 Labor 9 2013-07-01 2013-07-01 false Official Seal of the Occupational Safety and Health Review... Occupational Safety and Health Review Commission. The seal of the Commission shall consist of: A gold eagle... background, encircled by a white band edged in black and inscribed “Occupational Safety and Health Review...

29 CFR 2200.108 - Official Seal of the Occupational Safety and Health Review Commission.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 29 Labor 9 2012-07-01 2012-07-01 false Official Seal of the Occupational Safety and Health Review... Occupational Safety and Health Review Commission. The seal of the Commission shall consist of: A gold eagle... background, encircled by a white band edged in black and inscribed “Occupational Safety and Health Review...

Effect of electronic device use on pedestrian safety : a literature review.

DOT National Transportation Integrated Search

2016-04-01

This literature review on the effect of electronic device use on pedestrian safety is part of a research project sponsored by the Office of Behavioral Safety Research in the National Highway Traffic Safety Administration (NHTSA). An extensive literat...

Occupational safety and health management in the construction industry: a review.

PubMed

Jaafar, Mohd Hafiidz; Arifin, Kadir; Aiyub, Kadaruddin; Razman, Muhammad Rizal; Ishak, Muhammad Izzuddin Syakir; Samsurijan, Mohamad Shaharudin

2017-09-11

The construction industry plays a significant role in contributing to the economy and development globally. During the process of construction, various hazards coupled with the unique nature of the industry contribute to high fatality rates. This review refers to previous published studies and related Malaysian legislation documents. Four main elements consisting of human, worksite, management and external elements which cause occupational accidents and illnesses were identified. External and management elements are the underlying causes contributing to occupational safety and health (OSH), while human and worksite elements are more apparent causes of occupational accidents and illnesses. An effective OSH management approach is required to contain all hazards at construction sites. An approach to OSH management constructed by elements of policy, process, personnel and incentive developed in previous work is explored. Changes to the sub-elements according to previous studies and the related Malaysian legislation are also covered in this review.

Impact of the time-out process on safety attitude in a tertiary neurosurgical department.

PubMed

McLaughlin, Nancy; Winograd, Deborah; Chung, Hallie R; Van de Wiele, Barbara; Martin, Neil A

2014-11-01

In July 2011, the UCLA Health System released its current time-out process protocol used across the Health System. Numerous interventions were performed to improve checklist completion and time-out process observance. This study assessed the impact of the current protocol for the time-out on healthcare providers' safety attitude and operating room safety climate. All members involved in neurosurgical procedures in the main operating room of the Ronald Reagan UCLA Medical Center were asked to anonymously complete an online survey on their overall perception of the time-out process. The survey was completed by 93 of 128 members of the surgical team. Overall, 98.9% felt that performing a pre-incision time-out improves patient safety. The majority of respondents (97.8%) felt that the team member introductions helped to promote a team spirit during the case. In addition, 93.5% felt that performing a time-out helped to ensure all team members were comfortable to voice safety concerns throughout the case. All respondents felt that the attending surgeon should be present during the time-out and 76.3% felt that he/she should lead the time-out. Unanimously, it was felt that the review of anticipated critical elements by the attending surgeon was helpful to respondents' role during the case. Responses revealed that although the time-out brings the team together physically, it does not necessarily reinforce teamwork. The time-out process favorably impacted team members' safety attitudes and perception as well as overall safety climate in neurosurgical ORs. Survey responses identified leadership training and teamwork training as two avenues for future improvement. Copyright © 2014 Elsevier Inc. All rights reserved.

The relationship between resident burnout and safety-related and acceptability-related quality of healthcare: a systematic literature review.

PubMed

Dewa, Carolyn S; Loong, Desmond; Bonato, Sarah; Trojanowski, Lucy; Rea, Margaret

2017-11-09

There has been increasing interest in examining the relationship between physician wellbeing and quality of patient care. However, few reviews have specifically focused on resident burnout and quality of patient care. The purpose of this systematic literature review of the current scientific literature is to address the question, "How does resident burnout affect the quality of healthcare related to the dimensions of acceptability and safety?" This systematic literature review uses a multi-step screening process of publicly available peer-reviewed studies from five electronic databases: (1) Medline Current, (2) Medline In-process, (3) PsycINFO, (4) Embase, and (5) Web of Science. The electronic literature search resulted in the identification of 4638 unique citations. Of these, 10 articles were included in the review. Studies were assessed for risk of bias. Of the 10 studies that met the inclusion criteria, eight were conducted in the US, one in The Netherlands, and one in Mexico. Eight of the 10 studies focused on patient safety. The results of these included studies suggest there is moderate evidence that burnout is associated with patient safety (i.e., resident self-perceived medical errors and sub-optimal care). There is less evidence that specific dimensions of burnout are related to acceptability (i.e., quality of care, communication with patients). The results of this systematic literature review suggest a relationship between patient safety and burnout. These results potentially have important implications for the medical training milieu because residents are still in training and at the same time are asked to teach students. The results also indicate a need for more evidence-based interventions that support continued research examining quality of care measures, especially as they relate to acceptability.

Health and safety impacts of nuclear, geothermal, and fossil-fuel electric generation in California. Volume 9. Methodologies for review of the health and safety aspects of proposed nuclear, geothermal, and fossil-fuel sites and facilities

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

Nero, A.V.; Quinby-Hunt, M.S.

1977-01-01

This report sets forth methodologies for review of the health and safety aspects of proposed nuclear, geothermal, and fossil-fuel sites and facilities for electric power generation. The review is divided into a Notice of Intention process and an Application for Certification process, in accordance with the structure to be used by the California Energy Resources Conservation and Development Commission, the first emphasizing site-specific considerations, the second examining the detailed facility design as well. The Notice of Intention review is divided into three possible stages: an examination of emissions and site characteristics, a basic impact analysis, and an assessment of publicmore » impacts. The Application for Certification review is divided into five possible stages: a review of the Notice of Intention treatment, review of the emission control equipment, review of the safety design, review of the general facility design, and an overall assessment of site and facility acceptability.« less

Healthcare Staff Wellbeing, Burnout, and Patient Safety: A Systematic Review.

PubMed

Hall, Louise H; Johnson, Judith; Watt, Ian; Tsipa, Anastasia; O'Connor, Daryl B

2016-01-01

To determine whether there is an association between healthcare professionals' wellbeing and burnout, with patient safety. Systematic research review. PsychInfo (1806 to July 2015), Medline (1946 to July 2015), Embase (1947 to July 2015) and Scopus (1823 to July 2015) were searched, along with reference lists of eligible articles. Quantitative, empirical studies that included i) either a measure of wellbeing or burnout, and ii) patient safety, in healthcare staff populations. Forty-six studies were identified. Sixteen out of the 27 studies that measured wellbeing found a significant correlation between poor wellbeing and worse patient safety, with six additional studies finding an association with some but not all scales used, and one study finding a significant association but in the opposite direction to the majority of studies. Twenty-one out of the 30 studies that measured burnout found a significant association between burnout and patient safety, whilst a further four studies found an association between one or more (but not all) subscales of the burnout measures employed, and patient safety. Poor wellbeing and moderate to high levels of burnout are associated, in the majority of studies reviewed, with poor patient safety outcomes such as medical errors, however the lack of prospective studies reduces the ability to determine causality. Further prospective studies, research in primary care, conducted within the UK, and a clearer definition of healthcare staff wellbeing are needed. This review illustrates the need for healthcare organisations to consider improving employees' mental health as well as creating safer work environments when planning interventions to improve patient safety. PROSPERO registration number: CRD42015023340.

Technical Letter Report: Evaluation and Analysis of a Few International Periodic Safety Review Summary Reports

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

Chopra, Omesh K.; Diercks, Dwight R.; Ma, David Chia-Chiun

At the request of the United States (U.S.) government, the International Atomic Energy Agency (IAEA) assembled a team of 20 senior safety experts to review the regulatory framework for the safety of operating nuclear power plants in the United States. This review focused on the effectiveness of the regulatory functions implemented by the NRC and on its commitment to nuclear safety and continuous improvement. One suggestion resulting from that review was that the U.S. Nuclear Regulatory Commission (NRC) incorporate lessons learned from periodic safety reviews (PSRs) performed in other countries as an input to the NRC’s assessment processes. In themore » U.S., commercial nuclear power plants (NPPs) are granted an initial 40-year operating license, which may be renewed for additional 20-year periods, subject to complying with regulatory requirements. The NRC has established a framework through its inspection, and operational experience processes to ensure the safe operation of licensed nuclear facilities on an ongoing basis. In contrast, most other countries do not impose a specific time limit on the operating licenses for NPPs, they instead require that the utility operating the plant perform PSRs, typically at approximately 10-year intervals, to assure continued safe operation until the next assessment. The staff contracted with Argonne National Laboratory (Argonne) to perform a pilot review of selected translated PSR assessment reports and related documentation from foreign nuclear regulatory authorities to identify any potential new regulatory insights regarding license renewal-related topics and NPP operating experience (OpE). A total of 14 PSR assessment documents from 9 countries were reviewed. For all of the countries except France, individual reports were provided for each of the plants reviewed. In the case of France, three reports were provided that reviewed the performance assessment of thirty-four 900-MWe reactors of similar design commissioned

Safety Considerations in the Chemical Process Industries

NASA Astrophysics Data System (ADS)

Englund, Stanley M.

There is an increased emphasis on chemical process safety as a result of highly publicized accidents. Public awareness of these accidents has provided a driving force for industry to improve its safety record. There has been an increasing amount of government regulation.

Identifying nontechnical skills associated with safety in the emergency department: a scoping review of the literature.

PubMed

Flowerdew, Lynsey; Brown, Ruth; Vincent, Charles; Woloshynowych, Maria

2012-05-01

Understanding the nontechnical skills specifically applicable to the emergency department (ED) is essential to facilitate training and more broadly consider interventions to reduce error. The aim of this scoping review is to first identify and then explore in depth the nontechnical skills linked to safety in the ED. The review was conducted in 2 stages. In stage 1, online databases were searched for published empirical studies linking nontechnical skills to safety and performance in the ED. Articles were analyzed to identify key ED nontechnical skills. In stage 2, these key skills were used to generate additional key words, which enabled a second search of the literature to be undertaken and expand on the evidence available for review. In stage 1, 11 articles were retrieved for data analysis and 9 core emergency medicine nontechnical skills were identified. These were communicating, managing workload, anticipating, situational awareness, supervising and providing feedback, leadership, maintaining standards, using assertiveness, and decisionmaking. In stage 2, a secondary search, using these 9 skills and related terms, uncovered a further 21 relevant articles. Therefore, 32 articles were used to describe the main nontechnical skills linked to safety in the ED. This article highlights the challenges of reviewing a topic for which the terms are not clearly defined in the literature. A novel methodological approach is described that provides a structured and transparent process for reviewing the literature in emerging areas of interest. A series of literature reviews focusing on individual nontechnical skills will provide a clearer understanding of how the skills identified contribute to safety in the ED. Copyright © 2011 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

The Evolution of Process Safety: Current Status and Future Direction.

PubMed

Mannan, M Sam; Reyes-Valdes, Olga; Jain, Prerna; Tamim, Nafiz; Ahammad, Monir

2016-06-07

The advent of the industrial revolution in the nineteenth century increased the volume and variety of manufactured goods and enriched the quality of life for society as a whole. However, industrialization was also accompanied by new manufacturing and complex processes that brought about the use of hazardous chemicals and difficult-to-control operating conditions. Moreover, human-process-equipment interaction plus on-the-job learning resulted in further undesirable outcomes and associated consequences. These problems gave rise to many catastrophic process safety incidents that resulted in thousands of fatalities and injuries, losses of property, and environmental damages. These events led eventually to the necessity for a gradual development of a new multidisciplinary field, referred to as process safety. From its inception in the early 1970s to the current state of the art, process safety has come to represent a wide array of issues, including safety culture, process safety management systems, process safety engineering, loss prevention, risk assessment, risk management, and inherently safer technology. Governments and academic/research organizations have kept pace with regulatory programs and research initiatives, respectively. Understanding how major incidents impact regulations and contribute to industrial and academic technology development provides a firm foundation to address new challenges, and to continue applying science and engineering to develop and implement programs to keep hazardous materials within containment. Here the most significant incidents in terms of their impact on regulations and the overall development of the field of process safety are described.

16 CFR 1021.4 - Overview of environmental review process for CPSC actions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Overview of environmental review process for CPSC actions. 1021.4 Section 1021.4 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL... detailed fashion. (See § 1021.10(a), below.) It contains sufficient information to form a basis for...

An electronic safety screening process during inpatient computerized physician order entry improves the efficiency of magnetic resonance imaging exams.

PubMed

Schneider, Erika; Ruggieri, Paul; Fromwiller, Lauren; Underwood, Reginald; Gurland, Brooke; Yurkschatt, Cynthia; Kubiak, Kevin; Obuchowski, Nancy A

2013-12-01

Delays between order and magnetic resonance (MR) exam often result when using the conventional paper-based MR safety screening process. The impact of an electronic MR safety screening process imbedded in a computerized physician order entry (CPOE) system was evaluated. Retrospective chart review of 4 months of inpatient MR exam orders and reports was performed before and after implementation of electronic MR safety documentation. Time from order to MR exam completion, time from MR exam completion to final radiology report, and time from first order to final report were analyzed by exam anatomy. Length of stay (LOS) and date of service within the admission were also analyzed. We evaluated 1947 individual MR orders in 1549 patients under an institutional review board exemption and a waiver of informed consent. Implementation of the electronic safety screening process resulted in a significant decrease of 1.1 hours (95% confidence interval 1.0-1.3 hours) in the mean time between first order to final report and a nonsignificant decrease of 0.8 hour in the median time from first order to exam end. There was a 1-day reduction (P = .697) in the time from admission to the MR exam compared to the paper process. No significant change in LOS was found except in neurological intensive care patients imaged within the first 24 hours of their admission, where a mean 0.9-day decrease was found. Benefits of an electronic process for MR safety screening include enabling inpatients to have decreased time to MR exams, thus enabling earlier diagnosis and treatment and reduced LOS. Copyright © 2013 AUR. Published by Elsevier Inc. All rights reserved.

Certification Processes for Safety-Critical and Mission-Critical Aerospace Software

NASA Technical Reports Server (NTRS)

Nelson, Stacy

2003-01-01

This document is a quick reference guide with an overview of the processes required to certify safety-critical and mission-critical flight software at selected NASA centers and the FAA. Researchers and software developers can use this guide to jumpstart their understanding of how to get new or enhanced software onboard an aircraft or spacecraft. The introduction contains aerospace industry definitions of safety and safety-critical software, as well as, the current rationale for certification of safety-critical software. The Standards for Safety-Critical Aerospace Software section lists and describes current standards including NASA standards and RTCA DO-178B. The Mission-Critical versus Safety-Critical software section explains the difference between two important classes of software: safety-critical software involving the potential for loss of life due to software failure and mission-critical software involving the potential for aborting a mission due to software failure. The DO-178B Safety-critical Certification Requirements section describes special processes and methods required to obtain a safety-critical certification for aerospace software flying on vehicles under auspices of the FAA. The final two sections give an overview of the certification process used at Dryden Flight Research Center and the approval process at the Jet Propulsion Lab (JPL).

Review of Exploration Systems Development (ESD) Integrated Hazard Development Process. Volume 1; Appendices

NASA Technical Reports Server (NTRS)

Smiles, Michael D.; Blythe, Michael P.; Bejmuk, Bohdan; Currie, Nancy J.; Doremus, Robert C.; Franzo, Jennifer C.; Gordon, Mark W.; Johnson, Tracy D.; Kowaleski, Mark M.; Laube, Jeffrey R.

2015-01-01

The Chief Engineer of the Exploration Systems Development (ESD) Office requested that the NASA Engineering and Safety Center (NESC) perform an independent assessment of the ESD's integrated hazard development process. The focus of the assessment was to review the integrated hazard analysis (IHA) process and identify any gaps/improvements in the process (e.g., missed causes, cause tree completeness, missed hazards). This document contains the outcome of the NESC assessment.

Review of Exploration Systems Development (ESD) Integrated Hazard Development Process. Appendices; Volume 2

NASA Technical Reports Server (NTRS)

Smiles, Michael D.; Blythe, Michael P.; Bejmuk, Bohdan; Currie, Nancy J.; Doremus, Robert C.; Franzo, Jennifer C.; Gordon, Mark W.; Johnson, Tracy D.; Kowaleski, Mark M.; Laube, Jeffrey R.

2015-01-01

The Chief Engineer of the Exploration Systems Development (ESD) Office requested that the NASA Engineering and Safety Center (NESC) perform an independent assessment of the ESD's integrated hazard development process. The focus of the assessment was to review the integrated hazard analysis (IHA) process and identify any gaps/improvements in the process (e.g. missed causes, cause tree completeness, missed hazards). This document contains the outcome of the NESC assessment.

Tank waste remediation system nuclear criticality safety program management review

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

BRADY RAAP, M.C.

1999-06-24

This document provides the results of an internal management review of the Tank Waste Remediation System (TWRS) criticality safety program, performed in advance of the DOE/RL assessment for closure of the TWRS Nuclear Criticality Safety Issue, March 1994. Resolution of the safety issue was identified as Hanford Federal Facility Agreement and Consent Order (Tri-Party Agreement) Milestone M-40-12, due September 1999.

Integrating system safety into the basic systems engineering process

NASA Technical Reports Server (NTRS)

Griswold, J. W.

1971-01-01

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

A Review of General Aviation Safety (1984-2017).

PubMed

Boyd, Douglas D

2017-07-01

General aviation includes all civilian aviation apart from operations involving paid passenger transport. Unfortunately, this category of aviation holds a lackluster safety record, accounting for 94% of civil aviation fatalities. In 2014, of 1143 general aviation accidents, 20% were fatal compared with 0 of 29 airline mishaps in the United States. Herein, research findings over the past 30 yr will be reviewed. Accident risk factors (e.g., adverse weather, geographical region, post-impact fire, gender differences) will be discussed. The review will also summarize the development and implementation of stringent crashworthiness designs with multi-axis dynamic testing and head-injury protection and its impact on mitigating occupant injury severity. The benefits and drawbacks of new technology and human factor considerations associated with increased general aviation automation will be debated. Data on the safety of the aging general aviation population and increased drug usage will also be described. Finally, areas in which general aviation occupant survival could be improved and injury severity mitigated will be discussed with the view of equipping aircraft with 1) crash-resistant fuel tanks to reduce post-impact conflagration; 2) after-market ballistic parachutes for older aircraft; and 3) current generation electronic locator beacons to hasten site access by first responders.Boyd DD. A review of general aviation safety (1984-2017). Aerosp Med Hum Perform. 2017; 88(7):657-664.

Safety cases for medical devices and health information technology: involving health-care organisations in the assurance of safety.

PubMed

Sujan, Mark A; Koornneef, Floor; Chozos, Nick; Pozzi, Simone; Kelly, Tim

2013-09-01

In the United Kingdom, there are more than 9000 reports of adverse events involving medical devices annually. The regulatory processes in Europe and in the United States have been challenged as to their ability to protect patients effectively from unreasonable risk and harm. Two of the major shortcomings of current practice include the lack of transparency in the safety certification process and the lack of involvement of service providers. We reviewed recent international standardisation activities in this area, and we reviewed regulatory practices in other safety-critical industries. The review showed that the use of safety cases is an accepted practice in UK safety-critical industries, but at present, there is little awareness of this concept in health care. Safety cases have the potential to provide greater transparency and confidence in safety certification and to act as a communication tool between manufacturers, service providers, regulators and patients.

A Review of Recent Advances in Perioperative Patient Safety.

PubMed

Fowler, Alexander J

2013-01-01

Major complications in surgery affect up to 16% of surgical procedures. Over the past 50 years, many patient safety initiatives have attempted to reduce such complications. Since the formation of the National Patient Safety Agency in 2001, there have been major advances in patient safety. Most recently, the production and implementation of the Surgical Safety Checklist by the World Health Organisation (WHO), a checklist ensuring that certain 'never events' (wrong-site surgery, wrong operation etc.) do not occur, irrespective of healthcare allowance. In this review, a summary of recent advances in patient safety are considered - including improvements in communication, understanding of human factors that cause mistakes, and strategies developed to minimise these. Additionally, the synthesis of best medical practice and harm minimisation is examined, with particular emphasis on communication and appreciation of human factors in the operating theatre. This is based on the resource management systems developed in other high risk industries (e.g. nuclear), and has also been adopted for other high risk medical areas. The WHO global movement to reduce surgical mortality has been highly successful, especially in the healthcare systems of developing nations where mortality reductions of up to 50% have been observed, and reductions in patient complications of 4%. Incident reporting has long been a key component of patient safety and continues to be so; allowing reflection and improved guideline formation. All patients are placed at risk in the surgical environment. It is crucial that this risk is minimised, whilst optimising the patient's outcome. In this review, recent advances in perioperative patient safety are examined and placed in context.

Aviation and healthcare: a comparative review with implications for patient safety.

PubMed

Kapur, Narinder; Parand, Anam; Soukup, Tayana; Reader, Tom; Sevdalis, Nick

2016-01-01

Safety in aviation has often been compared with safety in healthcare. Following a recent article in this journal, the UK government set up an Independent Patient Safety Investigation Service, to emulate a similar well-established body in aviation. On the basis of a detailed review of relevant publications that examine patient safety in the context of aviation practice, we have drawn up a table of comparative features and a conceptual framework for patient safety. Convergence and divergence of safety-related behaviours across aviation and healthcare were derived and documented. Key safety-related domains that emerged included Checklists, Training, Crew Resource Management, Sterile Cockpit, Investigation and Reporting of Incidents and Organisational Culture. We conclude that whilst healthcare has much to learn from aviation in certain key domains, the transfer of lessons from aviation to healthcare needs to be nuanced, with the specific characteristics and needs of healthcare borne in mind. On the basis of this review, it is recommended that healthcare should emulate aviation in its resourcing of staff who specialise in human factors and related psychological aspects of patient safety and staff wellbeing. Professional and post-qualification staff training could specifically include Cognitive Bias Avoidance Training, as this appears to play a key part in many errors relating to patient safety and staff wellbeing.

Exploring the theory, barriers and enablers for patient and public involvement across health, social care and patient safety: a protocol for a systematic review of reviews.

PubMed

Ocloo, Josephine; Garfield, Sarah; Dawson, Shoba; Dean Franklin, Bryony

2017-10-24

The emergence of patient and public involvement (PPI) in healthcare in the UK can be traced as far back as the 1970s. More recently, campaigns by harmed patients and their relatives have emerged as a result of clinical failings in the NHS, challenging paternalistic healthcare, which have led to a new focus on PPI in quality and safety, nationally and internationally. Evidence suggests that PPI within patient safety is often atheoretical and located within a biomedical discourse. This review will explore the literature on PPI across patient safety, healthcare and social care to identify theory, barriers and enablers that can be used to develop PPI in patient safety. Systematic searches of three electronic bibliographic databases will be conducted, using both MeSH and free-text terms to identify empirical literature published from database inception to May 2017. The screening process will involve input from at least two researchers and any disagreement will be resolved through discussion with a third reviewer. Initial inclusion and exclusion criteria have been developed and will be refined iteratively throughout the process. Data extraction from included articles will be conducted by at least two researchers using a data extraction form. Extracted information will be analysed using a narrative review approach, which synthesises data using a descriptive method. No ethical approval is required for this review as no empirical data were collected. We believe that the findings and recommendations from this review will be particularly relevant for an audience of academics and policymakers. The findings will, therefore, be written up and disseminated in international peer-reviewed journals and academic conferences with a health focus. They will also be disseminated to leading health policy organisations in the NHS, such as NHS England and NHS Improvement and national policy bodies such as the Health Foundation. © Article author(s) (or their employer(s) unless otherwise

Office of Safety and Mission Assurance Review Report

NASA Technical Reports Server (NTRS)

2000-01-01

This document summarizes questions and concerns raised during the 1999 IV&V Facility's Annual Review Presentation to the Office of Safety and Mission Assurance (OSMA). Recommendations are provided for issues and action items identified.

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

PubMed

Salahuddin, Lizawati; Ismail, Zuraini

2015-11-01

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

41 CFR 128-1.8009 - Review of Seismic Safety Program.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Review of Seismic Safety Program. 128-1.8009 Section 128-1.8009 Public Contracts and Property Management Federal Property Management Regulations System (Continued) DEPARTMENT OF JUSTICE 1-INTRODUCTION 1.80-Seismic Safety Program...

Lessons learned from process incident databases and the process safety incident database (PSID) approach sponsored by the Center for Chemical Process Safety.

PubMed

Sepeda, Adrian L

2006-03-17

Learning from the experiences of others has long been recognized as a valued and relatively painless process. In the world of process safety, this learning method is an essential tool since industry has neither the time and resources nor the willingness to experience an incident before taking corrective or preventative steps. This paper examines the need for and value of process safety incident databases that collect incidents of high learning value and structure them so that needed information can be easily and quickly extracted. It also explores how they might be used to prevent incidents by increasing awareness and by being a tool for conducting PHAs and incident investigations. The paper then discusses how the CCPS PSID meets those requirements, how PSID is structured and managed, and its attributes and features.

A longitudinal study of clinical peer review's impact on quality and safety in U.S. hospitals.

PubMed

Edwards, Marc T

2013-01-01

Clinical peer review is the dominant method of event analysis in U.S. hospitals. It is pivotal to medical staff efforts to improve quality and safety, yet the quality assurance process model that has prevailed for the past 30 years evokes fear and is fundamentally antithetical to a culture of safety. Two prior national studies characterized a quality improvement model that corrects this dysfunction but failed to demonstrate progress toward its adoption despite a high rate of program change between 2007 and 2009. This study's online survey of 470 organizations participating in either of the prior studies further assessed relationships between clinical peer review program factors, including the degree of conformance to the quality improvement model (the QI model score), and subjectively measured program impact variables. Among the 300 hospitals (64%) that responded, the median QI model score was only 60 on a 100-point scale. Scores increased somewhat for the 2007 cohort (mean pair-wise difference of 5.9 [2-10]), but not for the 2009 cohort. The QI model is expanded as the result of the finding that self-reporting of adverse events, near misses, and hazardous conditions--an essential practice in high-reliability organizations--is no longer rare in hospitals. Self-reporting and the quality of case review are additional multivariate predictors of the perceived ongoing impact of clinical peer review on quality and safety, medical staff perceptions of the program, and medical staff engagement in quality and safety initiatives. Hospital leaders and trustees who seek to improve patient outcomes should facilitate the adoption of this best practice model for clinical peer review.

Background to new entrant safety fitness assurance process

DOT National Transportation Integrated Search

2000-03-01

This report presents the results of background research leading to the development of a New Entrant Safety Fitness Assurance Process, a prequalification and monitoring program for motor carriers entering interstate service. The New Entrant Safety Fit...

29 CFR 2200.108 - Official Seal of the Occupational Safety and Health Review Commission.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 29 Labor 9 2011-07-01 2011-07-01 false Official Seal of the Occupational Safety and Health Review... HEALTH REVIEW COMMISSION RULES OF PROCEDURE Miscellaneous Provisions § 2200.108 Official Seal of the Occupational Safety and Health Review Commission. The seal of the Commission shall consist of: A gold eagle...

29 CFR 2200.108 - Official Seal of the Occupational Safety and Health Review Commission.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 9 2010-07-01 2010-07-01 false Official Seal of the Occupational Safety and Health Review... HEALTH REVIEW COMMISSION RULES OF PROCEDURE Miscellaneous Provisions § 2200.108 Official Seal of the Occupational Safety and Health Review Commission. The seal of the Commission shall consist of: A gold eagle...

Trends in HFE Methods and Tools and Their Applicability to Safety Reviews

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

O'Hara, J.M.; Plott, C.; Milanski, J.

2009-09-30

The U.S. Nuclear Regulatory Commission's (NRC) conducts human factors engineering (HFE) safety reviews of applicant submittals for new plants and for changes to existing plants. The reviews include the evaluation of the methods and tools (M&T) used by applicants as part of their HFE program. The technology used to perform HFE activities has been rapidly evolving, resulting in a whole new generation of HFE M&Ts. The objectives of this research were to identify the current trends in HFE methods and tools, determine their applicability to NRC safety reviews, and identify topics for which the NRC may need additional guidance tomore » support the NRC's safety reviews. We conducted a survey that identified over 100 new HFE M&Ts. The M&Ts were assessed to identify general trends. Seven trends were identified: Computer Applications for Performing Traditional Analyses, Computer-Aided Design, Integration of HFE Methods and Tools, Rapid Development Engineering, Analysis of Cognitive Tasks, Use of Virtual Environments and Visualizations, and Application of Human Performance Models. We assessed each trend to determine its applicability to the NRC's review by considering (1) whether the nuclear industry is making use of M&Ts for each trend, and (2) whether M&Ts reflecting the trend can be reviewed using the current design review guidance. We concluded that M&T trends that are applicable to the commercial nuclear industry and are expected to impact safety reviews may be considered for review guidance development. Three trends fell into this category: Analysis of Cognitive Tasks, Use of Virtual Environments and Visualizations, and Application of Human Performance Models. The other trends do not need to be addressed at this time.« less

Why is patient safety so hard? A selective review of ethnographic studies.

PubMed

Dixon-Woods, Mary

2010-01-01

Ethnographic studies are valuable in studying patient safety. This is a narrative review of four reports of ethnographic studies of patient safety in UK hospitals conducted as part of the Patient Safety Research Programme. Three of these studies were undertaken in operating theatres and one in an A&E Department. The studies found that hospitals were rarely geared towards ensuring perfect performances. The coordination and mobilization of the large number of inter-dependent processes and resources needed to support the achievement of tasks was rarely optimal. This produced significant strain that staff learned to tolerate by developing various compensatory strategies. Teamwork and inter-professional communication did not always function sufficiently well to ensure that basic procedural information was shared or that the required sequence of events was planned. Staff did not always do the right things, for a wide range of different reasons, including contestations about what counted as the right thing. Structures of authority and accountability were not always clear or well-functioning. Patient safety incidents were usually not reported, though there were many different reasons for this. It can be concluded that securing patient safety is hard. There are multiple interacting influences on safety, and solutions need to be based on a sound understanding of the nature of the problems and which approaches are likely to be best suited to resolving them. Some solutions that appear attractive and straightforward are likely to founder. Addressing safety problems requires acknowledgement that patient safety is not simply a technical issue, but a site of organizational and professional politics.

Aviation and healthcare: a comparative review with implications for patient safety

PubMed Central

Parand, Anam; Soukup, Tayana; Reader, Tom; Sevdalis, Nick

2015-01-01

Safety in aviation has often been compared with safety in healthcare. Following a recent article in this journal, the UK government set up an Independent Patient Safety Investigation Service, to emulate a similar well-established body in aviation. On the basis of a detailed review of relevant publications that examine patient safety in the context of aviation practice, we have drawn up a table of comparative features and a conceptual framework for patient safety. Convergence and divergence of safety-related behaviours across aviation and healthcare were derived and documented. Key safety-related domains that emerged included Checklists, Training, Crew Resource Management, Sterile Cockpit, Investigation and Reporting of Incidents and Organisational Culture. We conclude that whilst healthcare has much to learn from aviation in certain key domains, the transfer of lessons from aviation to healthcare needs to be nuanced, with the specific characteristics and needs of healthcare borne in mind. On the basis of this review, it is recommended that healthcare should emulate aviation in its resourcing of staff who specialise in human factors and related psychological aspects of patient safety and staff wellbeing. Professional and post-qualification staff training could specifically include Cognitive Bias Avoidance Training, as this appears to play a key part in many errors relating to patient safety and staff wellbeing. PMID:26770817

Safety of ceftriaxone in paediatrics: a systematic review protocol.

PubMed

Zeng, Linan; Choonara, Imti; Zhang, Lingli; Xue, Song; Chen, Zhe; He, Miaomiao

2017-08-21

Ceftriaxone is widely used in children in the treatment of sepsis. However, concerns have been raised about the safety of ceftriaxone, especially in young children. The aim of this review is to systematically evaluate the safety of ceftriaxone in children of all age groups. MEDLINE, PubMed, Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, International Pharmaceutical Abstracts and adverse drug reaction (ADR) monitoring systems will be systematically searched for randomised controlled trials (RCTs), cohort studies, case-control studies, cross-sectional studies, case series and case reports evaluating the safety of ceftriaxone in children. The Cochrane risk of bias tool, Newcastle-Ottawa and quality assessment tools developed by the National Institutes of Health will be used for quality assessment. Meta-analysis of the incidence of ADRs from RCTs and prospective studies will be done. Subgroup analyses will be performed for age and dosage regimen. Formal ethical approval is not required as no primary data are collected. This systematic review will be disseminated through a peer-reviewed publication and at conference meetings. CRD42017055428. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Critical safety assurance factors for manned spacecraft - A fire safety perspective

NASA Technical Reports Server (NTRS)

Rodney, George A.

1990-01-01

Safety assurance factors for manned spacecraft are discussed with a focus on the Space Station Freedom. A hazard scenario is provided to demonstrate a process commonly used by safety engineers and other analysts to identify onboard safety risks. Fire strategies are described, including a review of fire extinguishing agents being considered for the Space Station. Lessons learned about fire safety technology in other areas are also noted. NASA and industry research on fire safety applications is discussed. NASA's approach to ensuring safety for manned spacecraft is addressed in the context of its multidiscipline program.

Driver Issues: Commercial Motor Vehicle Safety Literature Review

DOT National Transportation Integrated Search

2007-06-01

The objective of this project was to provide the Federal Motor Carrier Safety Administration (FMCSA) with a more complete understanding of the non-regulatory factors which make for safer commercial motor vehicle (CMV) drivers. Through the review of a...

A Review of Research on Driving Styles and Road Safety.

PubMed

Sagberg, Fridulv; Selpi; Piccinini, Giulio Francesco Bianchi; Engström, Johan

2015-11-01

The aim of this study was to outline a conceptual framework for understanding driving style and, on this basis, review the state-of-the-art research on driving styles in relation to road safety. Previous research has indicated a relationship between the driving styles adopted by drivers and their crash involvement. However, a comprehensive literature review of driving style research is lacking. A systematic literature search was conducted, including empirical, theoretical, and methodological research, on driving styles related to road safety. A conceptual framework was proposed whereby driving styles are viewed in terms of driving habits established as a result of individual dispositions as well as social norms and cultural values. Moreover, a general scheme for categorizing and operationalizing driving styles was suggested. On this basis, existing literature on driving styles and indicators was reviewed. Links between driving styles and road safety were identified and individual and sociocultural factors influencing driving style were reviewed. Existing studies have addressed a wide variety of driving styles, and there is an acute need for a unifying conceptual framework in order to synthesize these results and make useful generalizations. There is a considerable potential for increasing road safety by means of behavior modification. Naturalistic driving observations represent particularly promising approaches to future research on driving styles. Knowledge about driving styles can be applied in programs for modifying driver behavior and in the context of usage-based insurance. It may also be used as a means for driver identification and for the development of driver assistance systems. © 2015, Human Factors and Ergonomics Society.

Patient safety risks associated with telecare: a systematic review and narrative synthesis of the literature.

PubMed

Guise, Veslemøy; Anderson, Janet; Wiig, Siri

2014-11-25

Patient safety risk in the homecare context and patient safety risk related to telecare are both emerging research areas. Patient safety issues associated with the use of telecare in homecare services are therefore not clearly understood. It is unclear what the patient safety risks are, how patient safety issues have been investigated, and what research is still needed to provide a comprehensive picture of risks, challenges and potential harm to patients due to the implementation and use of telecare services in the home. Furthermore, it is unclear how training for telecare users has addressed patient safety issues. A systematic review of the literature was conducted to identify patient safety risks associated with telecare use in homecare services and to investigate whether and how these patient safety risks have been addressed in telecare training. Six electronic databases were searched in addition to hand searches of key items, reference tracking and citation tracking. Strict inclusion and exclusion criteria were set. All included items were assessed according to set quality criteria and subjected to a narrative synthesis to organise and synthesize the findings. A human factors systems framework of patient safety was used to frame and analyse the results. 22 items were included in the review. 11 types of patient safety risks associated with telecare use in homecare services emerged. These are in the main related to the nature of homecare tasks and practices, and person-centred characteristics and capabilities, and to a lesser extent, problems with the technology and devices, organisational issues, and environmental factors. Training initiatives related to safe telecare use are not described in the literature. There is a need to better identify and describe patient safety risks related to telecare services to improve understandings of how to avoid and minimize potential harm to patients. This process can be aided by reframing known telecare implementation

14 CFR 415.117 - Ground safety.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Ground safety. 415.117 Section 415.117... From a Non-Federal Launch Site § 415.117 Ground safety. (a) General. An applicant's safety review document must include a ground safety analysis report, and a ground safety plan for its launch processing...

14 CFR 415.117 - Ground safety.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Ground safety. 415.117 Section 415.117... From a Non-Federal Launch Site § 415.117 Ground safety. (a) General. An applicant's safety review document must include a ground safety analysis report, and a ground safety plan for its launch processing...

Defining and Measuring Safety Climate: A Review of the Construction Industry Literature.

PubMed

Schwatka, Natalie V; Hecker, Steven; Goldenhar, Linda M

2016-06-01

Safety climate measurements can be used to proactively assess an organization's effectiveness in identifying and remediating work-related hazards, thereby reducing or preventing work-related ill health and injury. This review article focuses on construction-specific articles that developed and/or measured safety climate, assessed safety climate's relationship with other safety and health performance indicators, and/or used safety climate measures to evaluate interventions targeting one or more indicators of safety climate. Fifty-six articles met our inclusion criteria, 80% of which were published after 2008. Our findings demonstrate that researchers commonly defined safety climate as perception based, but the object of those perceptions varies widely. Within the wide range of indicators used to measure safety climate, safety policies, procedures, and practices were the most common, followed by general management commitment to safety. The most frequently used indicators should and do reflect that the prevention of work-related ill health and injury depends on both organizational and employee actions. Safety climate scores were commonly compared between groups (e.g. management and workers, different trades), and often correlated with subjective measures of safety behavior rather than measures of ill health or objective safety and health outcomes. Despite the observed limitations of current research, safety climate has been promised as a useful feature of research and practice activities to prevent work-related ill health and injury. Safety climate survey data can reveal gaps between management and employee perceptions, or between espoused and enacted policies, and trigger communication and action to narrow those gaps. The validation of safety climate with safety and health performance data offers the potential for using safety climate measures as a leading indicator of performance. We discuss these findings in relation to the related concept of safety culture and

Hospital Board Oversight of Quality and Patient Safety: A Narrative Review and Synthesis of Recent Empirical Research

PubMed Central

Millar, Ross; Mannion, Russell; Freeman, Tim; Davies, Huw TO

2013-01-01

Context Recurring problems with patient safety have led to a growing interest in helping hospitals’ governing bodies provide more effective oversight of the quality and safety of their services. National directives and initiatives emphasize the importance of action by boards, but the empirical basis for informing effective hospital board oversight has yet to receive full and careful review. Methods This article presents a narrative review of empirical research to inform the debate about hospital boards’ oversight of quality and patient safety. A systematic and comprehensive search identified 122 papers for detailed review. Much of the empirical work appeared in the last ten years, is from the United States, and employs cross-sectional survey methods. Findings Recent empirical studies linking board composition and processes with patient outcomes have found clear differences between high- and low-performing hospitals, highlighting the importance of strong and committed leadership that prioritizes quality and safety and sets clear and measurable goals for improvement. Effective oversight is also associated with well-informed and skilled board members. External factors (such as regulatory regimes and the publication of performance data) might also have a role in influencing boards, but detailed empirical work on these is scant. Conclusions Health policy debates recognize the important role of hospital boards in overseeing patient quality and safety, and a growing body of empirical research has sought to elucidate that role. This review finds a number of areas of guidance that have some empirical support, but it also exposes the relatively inchoate nature of the field. Greater theoretical and methodological development is required if we are to secure more evidence-informed governance systems and practices that can contribute to safer care. PMID:24320168

[Evidence-based effectiveness of road safety interventions: a literature review].

PubMed

Novoa, Ana M; Pérez, Katherine; Borrell, Carme

2009-01-01

Only road safety interventions with scientific evidence supporting their effectiveness should be implemented. The objective of this study was to identify and summarize the available evidence on the effectiveness of road safety interventions in reducing road traffic collisions, injuries and deaths. All literature reviews published in scientific journals that assessed the effectiveness of one or more road safety interventions and whose outcome measure was road traffic crashes, injuries or fatalities were included. An exhaustive search was performed in scientific literature databases. The interventions were classified according to the evidence of their effectiveness in reducing road traffic injuries (effective interventions, insufficient evidence of effectiveness, ineffective interventions) following the structure of the Haddon matrix. Fifty-four reviews were included. Effective interventions were found before, during and after the collision, and across all factors: a) the individual: the graduated licensing system (31% road traffic injury reduction); b) the vehicle: electronic stability control system (2 to 41% reduction); c) the infrastructure: area-wide traffic calming (0 to 20%), and d) the social environment: speed cameras (7 to 30%). Certain road safety interventions are ineffective, mostly road safety education, and others require further investigation. The most successful interventions are those that reduce or eliminate the hazard and do not depend on changes in road users' behavior or on their knowledge of road safety issues. Interventions based exclusively on education are ineffective in reducing road traffic injuries.

The drug regulatory and review process in Guyana.

PubMed

Woo-Ming, R B

1993-01-01

After the old "Sale of Food and Drugs" Ordinance, Cap. 144 was repealed, the new Food and Drugs Act was enacted in 1971. This new Act has considerable flexibility and gives the Minister extensive authority to make Regulations (for carrying out the purposes and provisions of the Act). The Act controls the manufacture, importation, sale, advertising, labeling, packaging, and distribution of drug samples, and the testing of drugs. The Act also controls raw materials and finished products of drugs at the point of entry into the country, with a single agency coordinating both the inspection and analytical services. Developing countries could ensure the procurement of safe, good quality, and effective drugs and devices with the enactment of a similar Food and Drugs Act only. Rapid assessment of Drug Safety, Quality and Efficacy is done through Guyana's participation in the WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce. This certification scheme is highly commendable especially to third-world countries. The Food and Drug Regulations (1977) have several unique features for drug, cosmetic and device control and they allow for a system of centralized control with limited staff to enforce the legislation. In summary, enforcement of legislative control of imported pharmaceuticals and product evaluation can be considered strong points in the drug regulatory and review process in Guyana. A cautious attitude is observed so as to ensure efficacy, safety, and quality of drugs entering the market. This Drug Regulatory and Review Process is recommended for implementation by third-world countries with outdated drug legislation.(ABSTRACT TRUNCATED AT 250 WORDS)

Processes Contributing to the Maintenance of Flying Phobia: A Narrative Review

PubMed Central

Clark, Gavin I.; Rock, Adam J.

2016-01-01

Flying phobia is a highly prevalent anxiety disorder, which causes sufferers significant distress and life interference. The processes which maintain flying phobia remain poorly understood. A systematic search of the literature was performed to identify what research has been conducted into the processes which may be involved in the fear of flying and whether processes which are believed to maintain other anxiety disorder diagnoses have been investigated in flying phobia. The results of the literature review are presented and related to existing cognitive behavioral theory and research. The results indicate that little research has been conducted into a number of areas considered important in the wider cognitive behavioral literature on anxiety disorders: namely attention, mental imagery, memory, worry, and safety-seeking behaviors. The review proposes a hypothetical model, derived from cognitive behavioral theory, for the processes which may be involved in maintaining flying phobia, and considers a number of areas for future research. PMID:27313550

78 FR 11204 - Accreditation and Reaccreditation Process for Firms Under the Third Party Review Program: Part I...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-15

...] Accreditation and Reaccreditation Process for Firms Under the Third Party Review Program: Part I; Draft Guidance... announcing the availability of the draft guidance entitled ``Accreditation and Reaccreditation Process for... Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), requires FDA...

Occupational health and safety issues affecting young workers: a literature review.

PubMed

Laberge, Marie; Ledoux, Elise

2011-01-01

Many overview articles, reports, book chapters and literature reviews have examined the health and safety of young workers. These sources discuss the relationships between the work conditions of young workers and the various indicators of accidents and occupational diseases. Breslin et al. [12,13] conducted two literature reviews of quantitative studies to determine which factors best predicted work accidents and occupational disorders in young people. The present article proposes a review of young people's occupational health and safety (OHS) factors (e.g., demographic, individual, professional, organizational, temporal and operational factors) in both qualitative and quantitative studies. Five types of problems were analyzed in greater depth, namely MSD symptoms, respiratory, allergy and toxicological problems, mental health and well-being, alcohol and drug consumption, and fatigue. This review likewise examines related dimensions that allow us to adopt a more global perspective on this subject by considering such elements as young people's values, their knowledge and attitudes, safety practices in companies, the safe integration of young people, and rehabilitation. A total of 189 scientific articles were selected on the basis of certain criteria. These articles came from refereed OHS journals published between 1994 and 2005.

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

PubMed

2017-01-01

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

A systematic review of the safety climate intervention literature: Past trends and future directions.

PubMed

Lee, Jin; Huang, Yueng-Hsiang; Cheung, Janelle H; Chen, Zhuo; Shaw, William S

2018-04-26

Safety climate represents the meaningfulness of safety and how safety is valued in an organization. The contributions of safety climate to organizational safety have been well documented. There is a dearth of empirical research, however, on specific safety climate interventions and their effectiveness. The present study aims at examining the trend of safety climate interventions and offering compiled information for designing and implementing evidence-based safety climate interventions. Our literature search yielded 384 titles that were inspected by three examiners. Using a stepwise process that allowed for assessment of interobserver agreement, 19 full articles were selected and reviewed. Results showed that 10 out of the 19 articles (52.6%) were based on a quasi-experimental pre- and postintervention design, whereas 42.1% (n = 8) studies were based on a mixed-design approach (including both between- and within-subject design). All interventions in these 19 studies involved either safety-/health-related communication or education/training. Improvement of safety leadership was also a common component of safety climate interventions. According to the socio-technical systems classification of intervention strategies, all studies were categorized as interventions focusing on improving organizational and managerial structure as well as the personnel subsystem; four of them also aimed at improving technological aspects of work, and five of them aimed at improving the physical work subsystem. In general, a vast majority of the studies (89.5%, n = 17) showed a statistically significant improvement in safety climate across their organizations postintervention. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

40 CFR 68.65 - Process safety information.

Code of Federal Regulations, 2012 CFR

2012-07-01

... (CONTINUED) CHEMICAL ACCIDENT PREVENTION PROVISIONS Program 3 Prevention Program § 68.65 Process safety... data; (4) Reactivity data: (5) Corrosivity data; (6) Thermal and chemical stability data; and (7...; (ii) Process chemistry; (iii) Maximum intended inventory; (iv) Safe upper and lower limits for such...

Nuclear Safety

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

Silver, E G

This document is a review journal that covers significant developments in the field of nuclear safety. Its scope includes the analysis and control of hazards associated with nuclear energy, operations involving fissionable materials, and the products of nuclear fission and their effects on the environment. Primary emphasis is on safety in reactor design, construction, and operation; however, the safety aspects of the entire fuel cycle, including fuel fabrication, spent-fuel processing, nuclear waste disposal, handling of radioisotopes, and environmental effects of these operations, are also treated.

[The transition process from the intensive care unit to the ward: a review of the literature].

PubMed

Vázquez Calatayud, M; Portillo, M C

2013-01-01

The optimum transition process from the ICU to the ward is key to avoiding the appearance of anxiety in the patient and family, increase of re-admissions in the ICU with the consequent increase in costs and jeopardization to the patient's safety. 1) To identify, study and give a critical presentation of the existing evidence on how patients, families and nurses experience the transition from ICU to the ward; 2) to analyze the possible interventions available for the development of an optimum transition process. A review was made of the evidence available in the main databases. In addition, several journals specialized in Intensive Care were reviewed. Studies with a qualitative, quantitative or mixed approach and reviews on the subject with a systematic methodology or narrative reviews were included. A total of 23 papers were selected for review, 10 of which were qualitative studies, 11 quantitative and two had combined methodology. «Transfer anxiety» was identified after the analysis of these articles as one of the recurring aspects. Discrepancies regarding who should take responsibility for the preparation of the transition process and when it should be performed were also found. In the literature reviewed, several interventions have been proposed to facilitate an optimal transition process such as developing information brochures, creating a profile of practicing nursing liaison between the ICU and the ward and ICU discharge report. This review emphasizes the importance of taking into account the perspectives of patients, families and nurses to perform optimal planning of the transition of the patient from the ICU to the ward to ensure their safety. Copyright © 2012 Elsevier España, S.L. y SEEIUC. All rights reserved.

Reviewing methodologically disparate data: a practical guide for the patient safety research field.

PubMed

Brown, Katrina F; Long, Susannah J; Athanasiou, Thanos; Vincent, Charles A; Kroll, J Simon; Sevdalis, Nick

2012-02-01

This article addresses key questions frequently asked by researchers conducting systematic reviews in patient safety. This discipline is relatively young, and asks complex questions about complex aspects of health care delivery and experience, therefore its studies are typically methodologically heterogeneous, non-randomized and complex; but content rich and highly relevant to practice. Systematic reviews are increasingly necessary to drive forward practice and research in this area, but the data do not always lend themselves to 'standard' review methodologies. This accessible 'how-to' article demonstrates that data diversity need not preclude high-quality systematic reviews. It draws together information from published guidelines and experience within our multidisciplinary patient safety research group to provide entry-level advice for the clinician-researcher new to systematic reviewing, to non-biomedical research data or to both. It offers entry-level advice, illustrated with detailed practical examples, on defining a research question, creating a comprehensive search strategy, selecting articles for inclusion, assessing study quality, extracting data, synthesizing data and evaluating the impact of your review. The article concludes with a comment on the vital role of robust systematic reviews in the continuing advancement of the patient safety field. © 2010 Blackwell Publishing Ltd.

Dialysis Facility Safety: Processes and Opportunities.

PubMed

Garrick, Renee; Morey, Rishikesh

2015-01-01

Unintentional human errors are the source of most safety breaches in complex, high-risk environments. The environment of dialysis care is extremely complex. Dialysis patients have unique and changing physiology, and the processes required for their routine care involve numerous open-ended interfaces between providers and an assortment of technologically advanced equipment. Communication errors, both within the dialysis facility and during care transitions, and lapses in compliance with policies and procedures are frequent areas of safety risk. Some events, such as air emboli and needle dislodgments occur infrequently, but are serious risks. Other adverse events include medication errors, patient falls, catheter and access-related infections, access infiltrations and prolonged bleeding. A robust safety system should evaluate how multiple, sequential errors might align to cause harm. Systems of care can be improved by sharing the results of root cause analyses, and "good catches." Failure mode effects and analyses can be used to proactively identify and mitigate areas of highest risk, and methods drawn from cognitive psychology, simulation training, and human factor engineering can be used to advance facility safety. © 2015 Wiley Periodicals, Inc.

Spaceflight Safety on the North Coast of America

NASA Technical Reports Server (NTRS)

Ciancone, Michael L.; Havenhill, Maria T.; Terlep, Judith A.

1996-01-01

Spaceflight Safety (SFS) engineers at NASA Lewis Research Center (LeRC) are responsible for evaluating the microgravity fluids and combustion experiments, payloads and facilities developed at NASA LeRC which are manifested for spaceflight on the Space Shuttle, the Russian space station Mir, and/or the International Space Station (ISS). An ongoing activity at NASA LeRC is the comprehensive training of its SFS engineers through the creation and use of safety tools and processes. Teams of SFS engineers worked on the development of an Internet website (containing a spaceflight safety knowledge database and electronic templates of safety products) and the establishment of a technical peer review process (known as the Safety Assurance for Lewis Spaceflight Activities (SALSA) review).

Risk-based process safety assessment and control measures design for offshore process facilities.

PubMed

Khan, Faisal I; Sadiq, Rehan; Husain, Tahir

2002-09-02

Process operation is the most hazardous activity next to the transportation and drilling operation on an offshore oil and gas (OOG) platform. Past experiences of onshore and offshore oil and gas activities have revealed that a small mis-happening in the process operation might escalate to a catastrophe. This is of especial concern in the OOG platform due to the limited space and compact geometry of the process area, less ventilation, and difficult escape routes. On an OOG platform, each extra control measure, which is implemented, not only occupies space on the platform and increases congestion but also adds extra load to the platform. Eventualities in the OOG platform process operation can be avoided through incorporating the appropriate control measures at the early design stage. In this paper, the authors describe a methodology for risk-based process safety decision making for OOG activities. The methodology is applied to various offshore process units, that is, the compressor, separators, flash drum and driers of an OOG platform. Based on the risk potential, appropriate safety measures are designed for each unit. This paper also illustrates that implementation of the designed safety measures reduces the high Fatal accident rate (FAR) values to an acceptable level.

The Implementation and Maintenance of a Behavioral Safety Process in a Petroleum Refinery

ERIC Educational Resources Information Center

Myers, Wanda V.; McSween, Terry E.; Medina, Rixio E.; Rost, Kristen; Alvero, Alicia M.

2010-01-01

A values-centered and team-based behavioral safety process was implemented in a petroleum oil refinery. Employee teams defined the refinery's safety values and related practices, which were used to guide the process design and implementation. The process included (a) a safety assessment; (b) the clarification of safety-related values and related…

The relationship between physician burnout and quality of healthcare in terms of safety and acceptability: a systematic review

PubMed Central

Dewa, Carolyn S; Loong, Desmond; Bonato, Sarah; Trojanowski, Lucy

2017-01-01

Objectives This study reviews the current state of the published peer-reviewed literature related to physician burnout and two quality of care dimensions. The purpose of this systematic literature review is to address the question, ‘How does physician burnout affect the quality of healthcare related to the dimensions of acceptability and safety?’ Design Using a multiphase screening process, this systematic literature review is based on publically available peer-reviewed studies published between 2002 and 2017. Six electronic databases were searched: (1) MEDLINE Current, (2) MEDLINE In-process, (3) MEDLINE Epub Ahead of Print, (4) PsycINFO, (5) Embase and (6) Web of Science. Setting Physicians practicing in civilian settings. Participants Practicing physicians who have completed training. Primary and secondary outcome measures Quality of healthcare related to acceptability (ie, patient satisfaction, physician communication and physician attitudes) and safety (ie, minimising risks or harm to patients). Results 4114 unique citations were identified. Of these, 12 articles were included in the review. Two studies were rated as having high risk of bias and 10 as having moderate risk. Four studies were conducted in North America, four in Europe, one in the Middle East and three in East Asia. Results of this systematic literature review suggest there is moderate evidence that burnout is associated with safety-related quality of care. Because of the variability in the way patient acceptability-related quality of care was measured and the inconsistency in study findings, the evidence supporting the relationship between burnout and patient acceptability-related quality of care is less strong. Conclusions The focus on direct care-related quality highlights additional ways that physician burnout affects the healthcare system. These studies can help to inform decisions about how to improve patient care by addressing physician burnout. Continued work looking at the

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.

Do safety checklists improve teamwork and communication in the operating room? A systematic review.

PubMed

Russ, Stephanie; Rout, Shantanu; Sevdalis, Nick; Moorthy, Krishna; Darzi, Ara; Vincent, Charles

2013-12-01

The aim of this systematic review was to assess the impact of surgical safety checklists on the quality of teamwork and communication in the operating room (OR). Safety checklists have been shown to impact positively on patient morbidity and mortality following surgery, but it is unclear whether this clinical improvement is related to an improvement in OR teamwork and communication. A systematic search strategy of MEDLINE, EMBASE, PsycINFO, Google Scholar, and the Cochrane Database for Systematic Reviews was undertaken to obtain relevant articles. After de-duplication and the addition of limits, 315 articles were screened for inclusion by 2 researchers and all articles meeting a set of prespecified inclusion criteria were retained. Information regarding the type of checklist, study design, assessment tools used, outcomes, and study limitations was extracted. Twenty articles formed the basis of this systematic review. All articles described an empirical study relating to a case-specific safety checklist for surgery as the primary intervention, with some measure of change/improvement in teamwork and/or communication relating to its use. The methods for assessing teamwork and communication varied greatly, including surveys, observations, interviews, and 360° assessments. The evidence suggests that safety checklists improve the perceived quality of OR teamwork and communication and reduce observable errors relating to poor team skills. This is likely to function through establishing an open platform for communication at the start of a procedure: encouraging the sharing of critical case-related information, promoting team coordination and decision making, flagging knowledge gaps, and enhancing team cohesion. However, the evidence would also suggest that when used suboptimally or when individuals have not bought in to the process, checklists may conversely have a negative impact on the function of the team. Safety checklists are beneficial for OR teamwork and

Engineering and Safety Partnership Enhances Safety of the Space Shuttle Program (SSP)

NASA Technical Reports Server (NTRS)

Duarte, Alberto

2007-01-01

Project Management must use the risk assessment documents (RADs) as tools to support their decision making process. Therefore, these documents have to be initiated, developed, and evolved parallel to the life of the project. Technical preparation and safety compliance of these documents require a great deal of resources. Updating these documents after-the-fact not only requires substantial increase in resources - Project Cost -, but this task is also not useful and perhaps an unnecessary expense. Hazard Reports (HRs), Failure Modes and Effects Analysis (FMEAs), Critical Item Lists (CILs), Risk Management process are, among others, within this category. A positive action resulting from a strong partnership between interested parties is one way to get these documents and related processes and requirements, released and updated in useful time. The Space Shuttle Program (SSP) at the Marshall Space Flight Center has implemented a process which is having positive results and gaining acceptance within the Agency. A hybrid Panel, with equal interest and responsibilities for the two larger organizations, Safety and Engineering, is the focal point of this process. Called the Marshall Safety and Engineering Review Panel (MSERP), its charter (Space Shuttle Program Directive 110 F, April 15, 2005), and its Operating Control Plan emphasizes the technical and safety responsibilities over the program risk documents: HRs; FMEA/CILs; Engineering Changes; anomalies/problem resolutions and corrective action implementations, and trend analysis. The MSERP has undertaken its responsibilities with objectivity, assertiveness, dedication, has operated with focus, and has shown significant results and promising perspectives. The MSERP has been deeply involved in propulsion systems and integration, real time technical issues and other relevant reviews, since its conception. These activities have transformed the propulsion MSERP in a truly participative and value added panel, making a

Commercialization of Kennedy Space Center Instrumentation Developed to Improve Safety, Reliability, Cost Effectiveness of Space Shuttle Processing, Launch, and Landing

NASA Technical Reports Server (NTRS)

Helms, William R.; Starr, Stanley O.

1997-01-01

Priorities and achievements of the Kennedy Space Center (KSF) Instrumentation Laboratories in improving operational safety and decreasing processing costs associated with the Shuttle vehicle are addressed. Technologies that have been or are in the process of technology transfer are reviewed, and routes by which commercial concerns can obtain licenses to other KSF Instrumentation Laboratory technologies are discussed.

Mobile site safety review for the transuranic (TRU) waste characterization program

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

Not Available

1996-11-01

This Safety Review Document (SRD) applies to the Active/Passive Neutron Examination and Assay (APNEA) system installed on a Lockheed Martin Specialty Components, Inc., (Specialty Components) trailer. The APNEA is designed to perform nuclear waste drum assay. The purpose of this document is to describe the safety features of the APNEA system.

A Review of Interventions To Increase Driving Safety among Teenage Drivers.

ERIC Educational Resources Information Center

Mattox, John R., II

Young drivers across the United States represent a persistent traffic safety problem. Many interventions have been imposed on these drivers but few studies have evaluated the impact of these interventions on risky behaviors or traffic safety measures. To fill this gap, a review was undertaken to examine the most rigorous methodological evaluations…

Safety of human papillomavirus vaccines: a review

PubMed Central

Stillo, Michela; Carrillo Santisteve, Paloma; Lopalco, Pier Luigi

2015-01-01

Introduction: Between 2006 and 2009, two different human papillomavirus virus (HPV) vaccines were licensed for use: a quadrivalent (qHPVv) and a bivalent (bHPVv) vaccine. Since 2008, HPV vaccination programmes have been implemented in the majority of the industrialized countries. Since 2013, HPV vaccination has been part of the national programs of 66 countries including almost all countries in North America and Western Europe. Despite all the efforts made by individual countries, coverage rates are lower than expected. Vaccine safety represents one of the main concerns associated with the lack of acceptance of HPV vaccination both in the European Union/European Economic Area and elsewhere. Areas covered: Safety data published on bivalent and quadrivalent HPV vaccines, both in pre-licensure and post-licensure phase, are reviewed. Expert opinion: Based on the latest scientific evidence, both HPV vaccines seem to be safe. Nevertheless, public concern and rumors about adverse events (AE) represent an important barrier to overcome in order to increase vaccine coverage. Passive surveillance of AEs is an important tool for detecting safety signals, but it should be complemented by activities aimed at assessing the real cause of all suspect AEs. Improved vaccine safety surveillance is the first step for effective communication based on scientific evidence. PMID:25689872

Safety of human papillomavirus vaccines: a review.

PubMed

Stillo, Michela; Carrillo Santisteve, Paloma; Lopalco, Pier Luigi

2015-05-01

Between 2006 and 2009, two different human papillomavirus virus (HPV) vaccines were licensed for use: a quadrivalent (qHPVv) and a bivalent (bHPVv) vaccine. Since 2008, HPV vaccination programmes have been implemented in the majority of the industrialized countries. Since 2013, HPV vaccination has been part of the national programs of 66 countries including almost all countries in North America and Western Europe. Despite all the efforts made by individual countries, coverage rates are lower than expected. Vaccine safety represents one of the main concerns associated with the lack of acceptance of HPV vaccination both in the European Union/European Economic Area and elsewhere. Safety data published on bivalent and quadrivalent HPV vaccines, both in pre-licensure and post-licensure phase, are reviewed. Based on the latest scientific evidence, both HPV vaccines seem to be safe. Nevertheless, public concern and rumors about adverse events (AE) represent an important barrier to overcome in order to increase vaccine coverage. Passive surveillance of AEs is an important tool for detecting safety signals, but it should be complemented by activities aimed at assessing the real cause of all suspect AEs. Improved vaccine safety surveillance is the first step for effective communication based on scientific evidence.

Safety Analysis of Soybean Processing for Advanced Life Support

NASA Technical Reports Server (NTRS)

Hentges, Dawn L.

1999-01-01

Soybeans (cv. Hoyt) is one of the crops planned for food production within the Advanced Life Support System Integration Testbed (ALSSIT), a proposed habitat simulation for long duration lunar/Mars missions. Soybeans may be processed into a variety of food products, including soymilk, tofu, and tempeh. Due to the closed environmental system and importance of crew health maintenance, food safety is a primary concern on long duration space missions. Identification of the food safety hazards and critical control points associated with the closed ALSSIT system is essential for the development of safe food processing techniques and equipment. A Hazard Analysis Critical Control Point (HACCP) model was developed to reflect proposed production and processing protocols for ALSSIT soybeans. Soybean processing was placed in the type III risk category. During the processing of ALSSIT-grown soybeans, critical control points were identified to control microbiological hazards, particularly mycotoxins, and chemical hazards from antinutrients. Critical limits were suggested at each CCP. Food safety recommendations regarding the hazards and risks associated with growing, harvesting, and processing soybeans; biomass management; and use of multifunctional equipment were made in consideration of the limitations and restraints of the closed ALSSIT.

Usability and Safety in Electronic Medical Records Interface Design: A Review of Recent Literature and Guideline Formulation.

PubMed

Zahabi, Maryam; Kaber, David B; Swangnetr, Manida

2015-08-01

The objectives of this study were to (a) review electronic medical record (EMR) and related electronic health record (EHR) interface usability issues, (b) review how EMRs have been evaluated with safety analysis techniques along with any hazard recognition, and (c) formulate design guidelines and a concept for enhanced EMR interfaces with a focus on diagnosis and documentation processes. A major impact of information technology in health care has been the introduction of EMRs. Although numerous studies indicate use of EMRs to increase health care quality, there remain concerns with usability issues and safety. A literature search was conducted using Compendex, PubMed, CINAHL, and Web of Science databases to find EMR research published since 2000. Inclusion criteria included relevant English-language papers with subsets of keywords and any studies (manually) identified with a focus on EMR usability. Fifty studies met the inclusion criteria. Results revealed EMR and EHR usability problems to include violations of natural dialog, control consistency, effective use of language, effective information presentation, and customization principles as well as a lack of error prevention, minimization of cognitive load, and feedback. Studies focusing on EMR system safety made no objective assessments and applied only inductive reasoning methods for hazard recognition. On the basis of the identified usability problems and structure of safety analysis techniques, we provide EMR design guidelines and a design concept focused on the diagnosis process and documentation. The design guidelines and new interface concept can be used for prototyping and testing enhanced EMRs. © 2015, Human Factors and Ergonomics Society.

Passenger safety, health, and comfort: a review.

PubMed

Rayman, R B

1997-05-01

Since the birth of aviation medicine approximately 80 yrs ago, practitioners and scientists have given their attention primarily to flight deck crew, cabin crew, and ground support personnel. However, in more recent years we have broadened our horizons to include the safety, health, and comfort of passengers flying commercial aircraft. This will be even more compelling as more passengers take to the air in larger aircraft and flying longer hours to more distant destinations. Further, we can expect to see more older passengers because people in many countries are living longer, healthier lives. The author first discusses the stresses imposed by ordinary commercial flight upon travelers such as airport tumult, barometric pressure changes, immobility, jet lag, noise/ vibration, and radiation. Medical considerations are next addressed describing inflight illness and medical care capability aboard U.S. air carriers. Passenger safety, cabin air quality, and the preventive medicine aspects of air travel are next reviewed in the context of passenger safety, health, and comfort. Recommendations are addressed to regulator agencies, airlines aircraft manufacturers, and the aerospace medicine community.

Prevention through pre-review in occupational health and safety.

PubMed Central

Richter, E D; Kretzmer, D

1980-01-01

Occupational health problems have needlessly been produced at many worksites as a consequence of their not having been anticipated during design and construction. Pre-review may be an effective and efficient mechanism for preventive intervention in occupational health and safety. Legal and administrative precedents are cited from the United States and other countries. Proposals are presented, with Israel as an example, which aim to implement the principle of pre-review. PMID:7352610

Food Safety Evaluation Based on Near Infrared Spectroscopy and Imaging: A Review.

PubMed

Fu, Xiaping; Ying, Yibin

2016-08-17

In recent years, due to the increasing consciousness of food safety and human health, much progress has been made in developing rapid and nondestructive techniques for the evaluation of food hazards, food authentication, and traceability. Near infrared (NIR) spectroscopy and imaging techniques have gained wide acceptance in many fields because of their advantages over other analytical techniques. Following a brief introduction of NIR spectroscopy and imaging basics, this review mainly focuses on recent NIR spectroscopy and imaging applications for food safety evaluation, including (1) chemical hazards detection; (2) microbiological hazards detection; (3) physical hazards detection; (4) new technology-induced food safety concerns; and (5) food traceability. The review shows NIR spectroscopy and imaging to be effective tools that will play indispensable roles for food safety evaluation. In addition, on-line/real-time applications of these techniques promise to be a huge growth field in the near future.

A Systematic Review of the Use of Social Media for Food Safety Risk Communication.

PubMed

Overbey, Katie N; Jaykus, Lee-Ann; Chapman, Benjamin J

2017-09-01

This article covers the current published literature related to the use of social media in food safety and infectious disease communication. The aim was to analyze literature recommendations and draw conclusions about how best to utilize social media for food safety risk communication going forward. A systematic literature review was conducted, and 24 articles were included for analysis. The inclusion criteria were (i) original peer-reviewed articles and (ii) primary focus on communication through social media about food safety and/or infectious diseases. Studies were coded for themes about social media applications, benefits, limitations, and best practices. Trust and personal beliefs were important drivers of social media use. The wide reach, immediacy, and information gathering capacities of social media were frequently cited benefits. Suggestions for social media best practices were inconsistent among studies, and study designs were highly variable. More evidence-based suggestions are needed to better establish guidelines for social media use in food safety and infectious disease risk communication. The information gleaned from this review can be used to create effective messages for shaping food safety behaviors.

A Review on Internet of Things for Defense and Public Safety

PubMed Central

Fraga-Lamas, Paula; Fernández-Caramés, Tiago M.; Suárez-Albela, Manuel; Castedo, Luis; González-López, Miguel

2016-01-01

The Internet of Things (IoT) is undeniably transforming the way that organizations communicate and organize everyday businesses and industrial procedures. Its adoption has proven well suited for sectors that manage a large number of assets and coordinate complex and distributed processes. This survey analyzes the great potential for applying IoT technologies (i.e., data-driven applications or embedded automation and intelligent adaptive systems) to revolutionize modern warfare and provide benefits similar to those in industry. It identifies scenarios where Defense and Public Safety (PS) could leverage better commercial IoT capabilities to deliver greater survivability to the warfighter or first responders, while reducing costs and increasing operation efficiency and effectiveness. This article reviews the main tactical requirements and the architecture, examining gaps and shortcomings in existing IoT systems across the military field and mission-critical scenarios. The review characterizes the open challenges for a broad deployment and presents a research roadmap for enabling an affordable IoT for defense and PS. PMID:27782052

A novel program to improve patient safety by integrating peer review into the emergency medicine residency curriculum.

PubMed

Strayer, Reuben J; Shy, Bradley D; Shearer, Peter L

2014-12-01

Evaluating the quality of care as part of a quality improvement process is required in many clinical environments by accrediting bodies. It produces metrics used to evaluate department and individual provider performance, provides outcomes-based feedback to clinicians, and identifies ways to reduce error. To improve patient safety and train our residents to perform peer review, we expanded our quality assurance program from a narrow, administrative process carried out by a small number of attendings to an educationally focused activity of much greater scope incorporating all residents on a monthly basis. We developed an explicit system by which residents analyze sets of high-risk cases and record their impressions onto structured databases, which are reviewed by faculty. At monthly meetings, results from the month's case reviews are presented, learning points discussed, and corrective actions are proposed. By integrating Clinical Quality Review (CQR) as a core, continuous component of the residency curriculum, we increased the number of cases reviewed more than 10-fold and implemented a variety of clinical process improvements. An anonymous survey conducted after 2 years of resident-led CQR indicated that residents value their exposure to the peer review process and feel it benefits them as clinicians, but also that the program requires a significant investment of time that can be burdensome. Copyright © 2014 Elsevier Inc. All rights reserved.

[Ecological security of wastewater treatment processes: a review].

PubMed

Yang, Sai; Hua, Tao

2013-05-01

Though the regular indicators of wastewater after treatment can meet the discharge requirements and reuse standards, it doesn't mean the effluent is harmless. From the sustainable point of view, to ensure the ecological and human security, comprehensive toxicity should be considered when discharge standards are set up. In order to improve the ecological security of wastewater treatment processes, toxicity reduction should be considered when selecting and optimizing the treatment processes. This paper reviewed the researches on the ecological security of wastewater treatment processes, with the focus on the purposes of various treatment processes, including the processes for special wastewater treatment, wastewater reuse, and for the safety of receiving waters. Conventional biological treatment combined with advanced oxidation technologies can enhance the toxicity reduction on the base of pollutants removal, which is worthy of further study. For the process aimed at wastewater reuse, the integration of different process units can complement the advantages of both conventional pollutants removal and toxicity reduction. For the process aimed at ecological security of receiving waters, the emphasis should be put on the toxicity reduction optimization of process parameters and process unit selection. Some suggestions for the problems in the current research and future research directions were put forward.

New graduate registered nurses' knowledge of patient safety and practice: A literature review.

PubMed

Murray, Melanie; Sundin, Deborah; Cope, Vicki

2018-01-01

To critically appraise available literature and summarise evidence pertaining to the patient safety knowledge and practices of new graduate registered nurses. Responsibility for patient safety should not be limited to the practice of the bedside nurses, rather the responsibility of all in the healthcare system. Previous research identified lapses in safety across the health care, more specifically with new practitioners. Understanding these gaps and what may be employed to counteract them is vital to ensuring patient safety. A focused review of research literature. The review used key terms and Boolean operators across a 5-year time frame in CINAHL, Medline, psycINFO and Google Scholar for research articles pertaining to the area of enquiry. Eighty-four articles met the inclusion criteria, 39 discarded due to irrelevant material and 45 articles were included in the literature review. This review acknowledges that nursing has different stages of knowledge and practice capabilities. A theory-practice gap for new graduate registered nurses exists, and transition to practice is a key learning period setting new nurses on the path to becoming expert practitioners. Within the literature, there was little to no acknowledgement of patient safety knowledge of the newly registered nurse. Issues raised in the 1970s remain a concern for today's new graduate registered nurses. Research has recognised several factors affecting transition from nursing student to new graduate registered nurse. These factors are leaving new practitioners open to potential errors and risking patient safety. Understanding the knowledge of a new graduate registered nurse upon entering clinical practice may assist in organisations providing appropriate clinical and theoretical support to these nurses during their transition. © 2017 John Wiley & Sons Ltd.

Work zone safety analysis and modeling: a state-of-the-art review.

PubMed

Yang, Hong; Ozbay, Kaan; Ozturk, Ozgur; Xie, Kun

2015-01-01

Work zone safety is one of the top priorities for transportation agencies. In recent years, a considerable volume of research has sought to determine work zone crash characteristics and causal factors. Unlike other non-work zone-related safety studies (on both crash frequency and severity), there has not yet been a comprehensive review and assessment of methodological approaches for work zone safety. To address this deficit, this article aims to provide a comprehensive review of the existing extensive research efforts focused on work zone crash-related analysis and modeling, in the hopes of providing researchers and practitioners with a complete overview. Relevant literature published in the last 5 decades was retrieved from the National Work Zone Crash Information Clearinghouse and the Transport Research International Documentation database and other public digital libraries and search engines. Both peer-reviewed publications and research reports were obtained. Each study was carefully reviewed, and those that focused on either work zone crash data analysis or work zone safety modeling were identified. The most relevant studies are specifically examined and discussed in the article. The identified studies were carefully synthesized to understand the state of knowledge on work zone safety. Agreement and inconsistency regarding the characteristics of the work zone crashes discussed in the descriptive studies were summarized. Progress and issues about the current practices on work zone crash frequency and severity modeling are also explored and discussed. The challenges facing work zone safety research are then presented. The synthesis of the literature suggests that the presence of a work zone is likely to increase the crash rate. Crashes are not uniformly distributed within work zones and rear-end crashes are the most prevalent type of crashes in work zones. There was no across-the-board agreement among numerous papers reviewed on the relationship between work zone

Efficacy and safety data of subsequent entry biologics pertinent to nephrology practice: a systematic review.

PubMed

Marin, Judith Genevieve; Leung, Marianna; Lo, Clifford; Tsao, Nicole W; Martinusen, Daniel J

2014-01-01

Subsequent entry biologics (SEBs) may soon be a reality in Canadian nephrology practice. Understanding the worldwide experience with these agents will be valuable to Canadian clinicians. To compare the efficacy and safety data between SEBs used in nephrology practice and their reference biologic. Systematic review. Ovid MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Database of Abstracts of Review of Effects, Cochrane Central Register of Controlled Trials. Adult patients with chronic kidney disease (CKD). Our systematic review follows the process outlined by Cochrane Reviews. For efficacy data, all randomized controlled trials (RCTs), quasi-RCTs and observational trials in nephrology practice were included. For safety data, case series, case reports, review articles in nephrology practice and pharmacovigilance programs were included as well. Only epoetin SEBs trials were published in the literature. Ten studies involving three different epoetin SEBs (epoetin zeta, HX575 and epoetin theta) were included. The mean epoetin dose used did not differ significantly between the SEBs and the reference product. For epoetin zeta and epoetin theta, the mean hemoglobin levels achieved in the studies were similar between the SEBs and the reference epoetin. The HX 575 studies reported a mean absolute change in hemoglobin within the predefined equivalence margin, when compared with the reference biologic. In terms of safety data, 2 cases of pure-red-cell aplasia were linked to the subcutaneous administration of HX 575. Otherwise, the rate of adverse drug reactions was similar when epoetin SEBs were compared with the reference biologic. Our analysis is limited by the paucity of information available on SEB use in nephrology with the exception of epoetin SEBs. Methodological flaw was found in one of the epoetin zeta studies which accounted for 45% of pooled results. Little clinical difference was found between epoetin SEBs and the reference product. Although not deemed

Thirty Year Review of Safety Skill Instruction for Persons with Intellectual Disabilities

ERIC Educational Resources Information Center

Mechling, Linda C.

2008-01-01

This review synthesizes the empirical literature (1976-2006) focusing on teaching personal safety skills to persons with intellectual disabilities. Thirty-six investigations were identified which provided information on six areas of instruction: (a) pedestrian/street crossing safety; (b) home accident prevention; (c) application of first aid…

78 FR 64538 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-29

... for OMB Review; Comment Request; Safety Standards for Underground Coal Mine Ventilation--Belt Entry... the Mine Safety and Health Administration (MSHA) sponsored information collection request (ICR) titled, ``Safety Standards for Underground Coal Mine Ventilation--Belt Entry Used as an Intake Air Course to...

How important is vehicle safety in the new vehicle purchase process?

PubMed

Koppel, Sjaanie; Charlton, Judith; Fildes, Brian; Fitzharris, Michael

2008-05-01

Whilst there has been a significant increase in the amount of consumer interest in the safety performance of privately owned vehicles, the role that it plays in consumers' purchase decisions is poorly understood. The aims of the current study were to determine: how important vehicle safety is in the new vehicle purchase process; what importance consumers place on safety options/features relative to other convenience and comfort features, and how consumers conceptualise vehicle safety. In addition, the study aimed to investigate the key parameters associated with ranking 'vehicle safety' as the most important consideration in the new vehicle purchase. Participants recruited in Sweden and Spain completed a questionnaire about their new vehicle purchase. The findings from the questionnaire indicated that participants ranked safety-related factors (e.g., EuroNCAP (or other) safety ratings) as more important in the new vehicle purchase process than other vehicle factors (e.g., price, reliability etc.). Similarly, participants ranked safety-related features (e.g., advanced braking systems, front passenger airbags etc.) as more important than non-safety-related features (e.g., route navigation systems, air-conditioning etc.). Consistent with previous research, most participants equated vehicle safety with the presence of specific vehicle safety features or technologies rather than vehicle crash safety/test results or crashworthiness. The key parameters associated with ranking 'vehicle safety' as the most important consideration in the new vehicle purchase were: use of EuroNCAP, gender and education level, age, drivers' concern about crash involvement, first vehicle purchase, annual driving distance, person for whom the vehicle was purchased, and traffic infringement history. The findings from this study are important for policy makers, manufacturers and other stakeholders to assist in setting priorities with regard to the promotion and publicity of vehicle safety features

Development of a course review process.

PubMed

Persky, Adam M; Joyner, Pamela U; Cox, Wendy C

2012-09-10

To describe and assess a course review process designed to enhance course quality. A course review process led by the curriculum and assessment committees was designed for all required courses in the doctor of pharmacy (PharmD) program at a school of pharmacy. A rubric was used by the review team to address 5 areas: course layout and integration, learning outcomes, assessment, resources and materials, and learner interaction. One hundred percent of targeted courses, or 97% of all required courses, were reviewed from January to August 2010 (n=30). Approximately 3.5 recommendations per course were made, resulting in improvement in course evaluation items related to learning outcomes. Ninety-five percent of reviewers and 85% of course directors agreed that the process was objective and the course review process was important. The course review process was objective and effective in improving course quality. Future work will explore the effectiveness of an integrated, continual course review process in improving the quality of pharmacy education.

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

PubMed

Xie, Anping; Carayon, Pascale

2015-01-01

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

The role of hospital managers in quality and patient safety: a systematic review

PubMed Central

Parand, Anam; Dopson, Sue; Renz, Anna; Vincent, Charles

2014-01-01

Objectives To review the empirical literature to identify the activities, time spent and engagement of hospital managers in quality of care. Design A systematic review of the literature. Methods A search was carried out on the databases MEDLINE, PSYCHINFO, EMBASE, HMIC. The search strategy covered three facets: management, quality of care and the hospital setting comprising medical subject headings and key terms. Reviewers screened 15 447 titles/abstracts and 423 full texts were checked against inclusion criteria. Data extraction and quality assessment were performed on 19 included articles. Results The majority of studies were set in the USA and investigated Board/senior level management. The most common research designs were interviews and surveys on the perceptions of managerial quality and safety practices. Managerial activities comprised strategy, culture and data-centred activities, such as driving improvement culture and promotion of quality, strategy/goal setting and providing feedback. Significant positive associations with quality included compensation attached to quality, using quality improvement measures and having a Board quality committee. However, there is an inconsistency and inadequate employment of these conditions and actions across the sample hospitals. Conclusions There is some evidence that managers’ time spent and work can influence quality and safety clinical outcomes, processes and performance. However, there is a dearth of empirical studies, further weakened by a lack of objective outcome measures and little examination of actual actions undertaken. We present a model to summarise the conditions and activities that affect quality performance. PMID:25192876

Guidelines for Reviewers and the Editor at the Nuclear Safety Information Center.

ERIC Educational Resources Information Center

Whetsel, H. B.

The main purpose of this report is to help novice reviewers accelerate their apprenticeship at the Nuclear Safety Information Center, a computerized information service sponsored by the U.S. Atomic Energy Commission. Guidelines for reviewers are presented in Part 1; Part 2 contains guidelines for the novice editor. The goal of the reviewers and…

Review of Studies on Pedestrian and Bicyclist Safety, 1991-2007

DOT National Transportation Integrated Search

2012-06-01

This report reviews the pedestrian and bicyclist safety research literature in print as of 2007. It summarizes and synthesizes the key studies, evaluates existing knowledge and identifies research gaps and provides recommendations for future directio...

Margin of Safety Definition and Examples Used in Safety Basis Documents and the USQ Process

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

Beaulieu, R. A.

The Nuclear Safety Management final rule, 10 CFR 830, provides an undefined term, margin of safety (MOS). Safe harbors listed in 10 CFR 830, Table 2, such as DOE-STD-3009 use but do not define the term. This lack of definition has created the need for the definition. This paper provides a definition of MOS and documents examples of MOS as applied in a U.S. Department of Energy (DOE) approved safety basis for an existing nuclear facility. If we understand what MOS looks like regarding Technical Safety Requirements (TSR) parameters, then it helps us compare against other parameters that do notmore » involve a MOS. This paper also documents parameters that are not MOS. These criteria could be used to determine if an MOS exists in safety basis documents. This paper helps DOE, including the National Nuclear Security Administration (NNSA) and its contractors responsible for the safety basis improve safety basis documents and the unreviewed safety question (USQ) process with respect to MOS.« less

System safety management lessons learned from the US Army acquisition process

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

Piatt, J.A.

1989-05-01

The Assistant Secretary of the Army for Research, Development and Acquisition directed the Army Safety Center to provide an audit of the causes of accidents and safety of use restrictions on recently fielded systems by tracking residual hazards back through the acquisition process. The objective was to develop lessons learned'' that could be applied to the acquisition process to minimize mishaps in fielded systems. System safety management lessons learned are defined as Army practices or policies, derived from past successes and failures, that are expected to be effective in eliminating or reducing specific systemic causes of residual hazards. They aremore » broadly applicable and supportive of the Army structure and acquisition objectives. Pacific Northwest Laboratory (PNL) was given the task of conducting an independent, objective appraisal of the Army's system safety program in the context of the Army materiel acquisition process by focusing on four fielded systems which are products of that process. These systems included the Apache helicopter, the Bradley Fighting Vehicle (BFV), the Tube Launched, Optically Tracked, Wire Guided (TOW) Missile and the High Mobility Multipurpose Wheeled Vehicle (HMMWV). The objective of this study was to develop system safety management lessons learned associated with the acquisition process. The first step was to identify residual hazards associated with the selected systems. Since it was impossible to track all residual hazards through the acquisition process, certain well-known, high visibility hazards were selected for detailed tracking. These residual hazards illustrate a variety of systemic problems. Systemic or process causes were identified for each residual hazard and analyzed to determine why they exist. System safety management lessons learned were developed to address related systemic causal factors. 29 refs., 5 figs.« less

NASA's post-Challenger safety program - Themes and thrusts

NASA Technical Reports Server (NTRS)

Rodney, G. A.

1988-01-01

The range of managerial, technical, and procedural initiatives implemented by NASA's post-Challenger safety program is reviewed. The recommendations made by the Rogers Commission, the NASA post-Challenger review of Shuttle design, the Congressional investigation of the accident, the National Research Council, the Aerospace Safety Advisory Panel, and NASA internal advisory panels and studies are summarized. NASA safety initiatives regarding improved organizational accountability for safety, upgraded analytical techniques and methodologies for risk assessment and management, procedural initiatives in problem reporting and corrective-action tracking, ground processing, maintenance documentation, and improved technologies are discussed. Safety issues relevant to the planned Space Station are examined.

Controlled versus automatic processes: which is dominant to safety? The moderating effect of inhibitory control.

PubMed

Xu, Yaoshan; Li, Yongjuan; Ding, Weidong; Lu, Fan

2014-01-01

This study explores the precursors of employees' safety behaviors based on a dual-process model, which suggests that human behaviors are determined by both controlled and automatic cognitive processes. Employees' responses to a self-reported survey on safety attitudes capture their controlled cognitive process, while the automatic association concerning safety measured by an Implicit Association Test (IAT) reflects employees' automatic cognitive processes about safety. In addition, this study investigates the moderating effects of inhibition on the relationship between self-reported safety attitude and safety behavior, and that between automatic associations towards safety and safety behavior. The results suggest significant main effects of self-reported safety attitude and automatic association on safety behaviors. Further, the interaction between self-reported safety attitude and inhibition and that between automatic association and inhibition each predict unique variances in safety behavior. Specifically, the safety behaviors of employees with lower level of inhibitory control are influenced more by automatic association, whereas those of employees with higher level of inhibitory control are guided more by self-reported safety attitudes. These results suggest that safety behavior is the joint outcome of both controlled and automatic cognitive processes, and the relative importance of these cognitive processes depends on employees' individual differences in inhibitory control. The implications of these findings for theoretical and practical issues are discussed at the end.

Controlled versus Automatic Processes: Which Is Dominant to Safety? The Moderating Effect of Inhibitory Control

PubMed Central

Xu, Yaoshan; Li, Yongjuan; Ding, Weidong; Lu, Fan

2014-01-01

This study explores the precursors of employees' safety behaviors based on a dual-process model, which suggests that human behaviors are determined by both controlled and automatic cognitive processes. Employees' responses to a self-reported survey on safety attitudes capture their controlled cognitive process, while the automatic association concerning safety measured by an Implicit Association Test (IAT) reflects employees' automatic cognitive processes about safety. In addition, this study investigates the moderating effects of inhibition on the relationship between self-reported safety attitude and safety behavior, and that between automatic associations towards safety and safety behavior. The results suggest significant main effects of self-reported safety attitude and automatic association on safety behaviors. Further, the interaction between self-reported safety attitude and inhibition and that between automatic association and inhibition each predict unique variances in safety behavior. Specifically, the safety behaviors of employees with lower level of inhibitory control are influenced more by automatic association, whereas those of employees with higher level of inhibitory control are guided more by self-reported safety attitudes. These results suggest that safety behavior is the joint outcome of both controlled and automatic cognitive processes, and the relative importance of these cognitive processes depends on employees' individual differences in inhibitory control. The implications of these findings for theoretical and practical issues are discussed at the end. PMID:24520338

Panel Resource Management (PRM) Implementation and Effects within Safety Review Panel Settings and Dynamics

NASA Technical Reports Server (NTRS)

Taylor, Robert W.; Nash, Sally K.

2007-01-01

While technical training and advanced degree's assure proficiency at specific tasks within engineering disciplines, they fail to address the potential for communication breakdown and decision making errors familiar to multicultural environments where language barriers, intimidating personalities and interdisciplinary misconceptions exist. In an effort to minimize these pitfalls to effective panel review, NASA's lead safety engineers to the ISS Safety Review Panel (SRP), and Payload Safety Review Panel (PSRP) initiated training with their engineers, in conjunction with the panel chairs, and began a Panel Resource Management (PRM) program. The intent of this program focuses on the ability to reduce the barriers inhibiting effective participation from all panel attendees by bolstering participants confidence levels through increased communication skills, situational awareness, debriefing, and a better technical understanding of requirements and systems.

Air Travel Safety in Postoperative Breast Cancer Patients: A Systematic Review.

PubMed

Co, Michael; Ng, Judy; Kwong, Ava

2018-05-17

Air travel has long been a dilemma in post-breast cancer surgery patients. Anecdotal reports have described adverse outcomes on surgical wound, implants, and lymphedema during air travel. This review aims to evaluate the best evidence from the literature concerning the air travel safety in breast cancer patients. A comprehensive review was performed of the Medline, Embase, CINAHL, and Cochrane databases using a predefined strategy. Retrieved studies were independently screened and rated for relevance. Data were extracted by 2 researchers. We reviewed the best evidence on air travel safety in postoperative breast cancer patients. Evidence was limited in the current literature to suggest adverse effects on postoperative mastectomy wounds and drains by high-altitude travel. Similarly, adverse effects on breast implants were limited to case reports and ex vivo experiments. A systematic review of 12 studies concluded that air travel is not associated with upper limb lymphedema after breast cancer surgery. Deep-vein thrombosis (DVT) is a known complication after air travel; in addition, malignancy itself is a known risk factor for DVT. Evidence of safety to continue tamoxifen during the period of air travel is lacking in the literature. Evidence to support the use of systemic DVT prophylaxis in general postoperative breast cancer patients is also limited. Best evidence from a large retrospective study suggested that mechanical antiembolism devices and early mobilization are the only measures required. Air travel is generally safe in patients after breast cancer surgery. Copyright © 2018. Published by Elsevier Inc.

The Role of Patient Safety in the Device Purchasing Process

DTIC Science & Technology

2005-05-01

Juliana J. Brixey, Danielle Paige, James P. Turley Abstract To examine how patient safety considerations are incorporated into medical device...Despite the general awareness of patient safety, its importance, and its role in medical device comparisons and purchasing decisions, this study...into the medical device purchasing process. We presently have a set of guidelines in development to help hospitals better emphasize patient safety

Demystifying the peer-review process - workshop

EPA Science Inventory

Scientific writing and peer-review are integral parts of the publishing process. This workshop aims to demystify the peer-review process for early career scientists and provide insightful tips for streamlining the submission and peer review process for all researchers. Providing ...

The Joint Convention on the Safety of Spent fuel Management and on the safety of Radioactive Waste Management: A UK Regulator's Perspective

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

Lacey, D.; Bacon, M.L.

The UK fully supports the objective of the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management to achieve and maintain a high level of safety worldwide in spent fuel and radioactive waste management, through the enhancement of national measures and international co-operation, including where appropriate, safety-related co-operation. The UK's Health and Safety Executive, through its Nuclear Safety Directorate (NSD), has been committed to the Convention since the initial negotiations to set up the Convention and provided the president of the first review meeting in 2003. It would be wrong of anymore » nation to believe that they have all the best solutions to managing spent fuel and radioactive waste. The process of compiling reports for the Convention review meetings provides a structured process through which every contracting party can review its provisions against a common set of standards and identify for itself possible areas of improvements. The sharing of reports and the asking and answering of questions then provides a further opportunity for both sharing of experience and learning. The UK was encouraged by the spirit of constructive discussion rather than negative criticism that pervaded the first review meeting that provided an incentive for all to learn and improve. While, as could be expected of the first meeting of such a group, not everything worked as well as could be hoped for, all parties seemed committed to learn from mistakes and to make the process more effective. Lessons were learned from the Nuclear Safety Convention on the process of submitting reports electronically and the UK actively supported aims to use IAEA requirements documents as an additional focus for reports. This should, we hope, provide for even better benchmarking of achievements and provide feedback for improvements of the IAEA requirements where appropriate. In summary, the UK finds the Joint Convention process to be a

Increasing teen safety belt use: a program and literature review.

DOT National Transportation Integrated Search

2005-09-01

A comprehensive review of the scientific literature, State and Federal Government reports, and other sources of information : was conducted to determine the magnitude of the problem of teen safety belt use and to identify and summarize programs, : in...

Evaluation of Key Factors Impacting Feeding Safety in the Neonatal Intensive Care Unit: A Systematic Review.

PubMed

Matus, Bethany A; Bridges, Kayla M; Logomarsino, John V

2018-06-21

Individualized feeding care plans and safe handling of milk (human or formula) are critical in promoting growth, immune function, and neurodevelopment in the preterm infant. Feeding errors and disruptions or limitations to feeding processes in the neonatal intensive care unit (NICU) are associated with negative safety events. Feeding errors include contamination of milk and delivery of incorrect or expired milk and may result in adverse gastrointestinal illnesses. The purpose of this review was to evaluate the effect(s) of centralized milk preparation, use of trained technicians, use of bar code-scanning software, and collaboration between registered dietitians and registered nurses on feeding safety in the NICU. A systematic review of the literature was completed, and 12 articles were selected as relevant to search criteria. Study quality was evaluated using the Downs and Black scoring tool. An evaluation of human studies indicated that the use of centralized milk preparation, trained technicians, bar code-scanning software, and possible registered dietitian involvement decreased feeding-associated error in the NICU. A state-of-the-art NICU includes a centralized milk preparation area staffed by trained technicians, care supported by bar code-scanning software, and utilization of a registered dietitian to improve patient safety. These resources will provide nurses more time to focus on nursing-specific neonatal care. Further research is needed to evaluate the impact of factors related to feeding safety in the NICU as well as potential financial benefits of these quality improvement opportunities.

40 CFR 68.65 - Process safety information.

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) CHEMICAL ACCIDENT PREVENTION PROVISIONS Program 3 Prevention Program § 68.65 Process safety... data; (4) Reactivity data: (5) Corrosivity data; (6) Thermal and chemical stability data; and (7... operator shall document that equipment complies with recognized and generally accepted good engineering...

Drug use and highway safety : a review of the literature

DOT National Transportation Integrated Search

1971-07-01

This report reviews the research literature concerning several aspects of drug use as it relates to traffic safety. Some of the topics covered include the effects of drugs, types of drug users; research problems in assessing risk; laboratory findings...

Enhancing the role of case-oriented peer review to improve quality and safety in radiation oncology: Executive summary

PubMed Central

Marks, Lawrence B.; Adams, Robert D.; Pawlicki, Todd; Blumberg, Albert L.; Hoopes, David; Brundage, Michael D.; Fraass, Benedick A.

2013-01-01

This report is part of a series of white papers commissioned for the American Society for Radiation Oncology (ASTRO) Board of Directors as part of ASTRO's Target Safely Campaign, focusing on the role of peer review as an important component of a broad safety/quality assurance (QA) program. Peer review is one of the most effective means for assuring the quality of qualitative, and potentially controversial, patient-specific decisions in radiation oncology. This report summarizes many of the areas throughout radiation therapy that may benefit from the application of peer review. Each radiation oncology facility should evaluate the issues raised and develop improved ways to apply the concept of peer review to its individual process and workflow. This might consist of a daily multidisciplinary (eg, physicians, dosimetrists, physicists, therapists) meeting to review patients being considered for, or undergoing planning for, radiation therapy (eg, intention to treat and target delineation), as well as meetings to review patients already under treatment (eg, adequacy of image guidance). This report is intended to clarify and broaden the understanding of radiation oncology professionals regarding the meaning, roles, benefits, and targets for peer review as a routine quality assurance tool. It is hoped that this work will be a catalyst for further investigation, development, and study of the efficacy of peer review techniques and how these efforts can help improve the safety and quality of our treatments. PMID:24175002

[Road safety measures and their effects on traffic injuries: a systematic review].

PubMed

Aguilera, Sandra Lúcia Vieira Ulinski; Moysés, Simone Tetú; Moysés, Samuel Jorge

2014-10-01

To identify and summarize the findings of studies describing interventions aimed at reducing road traffic injuries. An integrative systematic review without meta-analysis was performed. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) were used to synthesize the findings of the articles reviewed. The keywords "traffic accidents", "review" and "public policy" were used in isolation or combined with boolean operator "And" to search PubMed, Web of Science, SciELO, and LILACS for the period between 2006 and 2011 RESULTS: Twenty-two studies were included in the systematic review. Of these, two described engineering strategies, two described other road safety policies, three described education strategies, and 15 described law enforcement policies. Law enforcement had the most effective immediate results. Engineering strategies proved important to promote a safe environment. Finally, education strategies had an informative role and served to support other strategies, but did not seem sufficient to promote cultural changes regarding road safety. Law enforcement seems to be the most effective strategy to change the behavior of drivers, especially regarding speed limits and drinking and driving.

Statewide traffic safety study phase I : review of current traffic safety research, practice, analytical procedures and databases.

DOT National Transportation Integrated Search

2005-05-01

This report synthesized the research findings of Phase I of the Statewide Traffic Safety Study of Louisiana, sponsored by the Louisiana Department of Transportation and Development. The objective of Phase I was to provide a comprehensive review of th...

A Review on Internet of Things for Defense and Public Safety.

PubMed

Fraga-Lamas, Paula; Fernández-Caramés, Tiago M; Suárez-Albela, Manuel; Castedo, Luis; González-López, Miguel

2016-10-05

The Internet of Things (IoT) is undeniably transforming the way that organizations communicate and organize everyday businesses and industrial procedures. Its adoption has proven well suited for sectors that manage a large number of assets and coordinate complex and distributed processes. This survey analyzes the great potential for applying IoT technologies (i.e., data-driven applications or embedded automation and intelligent adaptive systems) to revolutionize modern warfare and provide benefits similar to those in industry. It identifies scenarios where Defense and Public Safety (PS) could leverage better commercial IoT capabilities to deliver greater survivability to the warfighter or first responders, while reducing costs and increasing operation efficiency and effectiveness. This article reviews the main tactical requirements and the architecture, examining gaps and shortcomings in existing IoT systems across the military field and mission-critical scenarios. The review characterizes the open challenges for a broad deployment and presents a research roadmap for enabling an affordable IoT for defense and PS.

Cultural safety as an ethic of care: a praxiological process.

PubMed

McEldowney, Rose; Connor, Margaret J

2011-10-01

New writings broadening the construct of cultural safety, a construct initiated in Aotearoa New Zealand, are beginning to appear in the literature. Therefore, it is considered timely to integrate these writings and advance the construct into a new theoretical model. The new model reconfigures the constructs of cultural safety and cultural competence as an ethic of care informed by a postmodern perspective. Central to the new model are three interwoven, co-occurring components: an ethic of care, which unfolds within a praxiological process shaped by the context. Context is expanded through identifying the three concepts of relationality, generic competence, and collectivity, which are integral to each client-nurse encounter. The competence associated with cultural safety as an ethic of care is always in the process of development. Clients and nurses engage in a dialogue to establish the level of cultural safety achieved at given points in a care trajectory.

Nuclear Criticality Safety Data Book

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

Hollenbach, D. F.

The objective of this document is to support the revision of criticality safety process studies (CSPSs) for the Uranium Processing Facility (UPF) at the Y-12 National Security Complex (Y-12). This design analysis and calculation (DAC) document contains development and justification for generic inputs typically used in Nuclear Criticality Safety (NCS) DACs to model both normal and abnormal conditions of processes at UPF to support CSPSs. This will provide consistency between NCS DACs and efficiency in preparation and review of DACs, as frequently used data are provided in one reference source.

78 FR 47804 - Verification, Validation, Reviews, and Audits for Digital Computer Software Used in Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-06

..., ``Configuration Management Plans for Digital Computer Software used in Safety Systems of Nuclear Power Plants... Digital Computer Software Used in Safety Systems of Nuclear Power Plants AGENCY: Nuclear Regulatory..., Reviews, and Audits for Digital Computer Software Used in Safety Systems of Nuclear Power Plants.'' This...

Proceedings of the Second NASA Aviation Safety Program Weather Accident Prevention Review

NASA Technical Reports Server (NTRS)

Martzaklis, K. Gus (Compiler)

2003-01-01

The Second NASA Aviation Safety Program (AvSP) Weather Accident Prevention (WxAP) Annual Project Review held June 5-7, 2001, in Cleveland, Ohio, presented the NASA technical plans and accomplishments to the aviation community. NASA-developed technologies presented included an Aviation Weather Information System with associated digital communications links, electronic atmospheric reporting technologies, forward-looking turbulence warning systems, and turbulence mitigation procedures. The meeting provided feedback and insight from the aviation community of diverse backgrounds and assisted NASA in steering its plans in the direction needed to meet the national safety goal of 80-percent reduction of aircraft accidents by 2007. The proceedings of the review are enclosed.

Critical Review of Commercial Secondary Lithium-Ion Battery Safety Standards

NASA Astrophysics Data System (ADS)

Jones, Harry P.; Chapin, Thomas, J.; Tabaddor, Mahmod

2010-09-01

The development of Li-ion cells with greater energy density has lead to safety concerns that must be carefully assessed as Li-ion cells power a wide range of products from consumer electronics to electric vehicles to space applications. Documented field failures and product recalls for Li-ion cells, mostly for consumer electronic products, highlight the risk of fire, smoke, and even explosion. These failures have been attributed to the occurrence of internal short circuits and the subsequent thermal runaway that can lead to fire and explosion. As packaging for some applications include a large number of cells, the risk of failure is likely to be magnified. To address concerns about the safety of battery powered products, safety standards have been developed. This paper provides a review of various international safety standards specific to lithium-ion cells. This paper shows that though the standards are harmonized on a host of abuse conditions, most lack a test simulating internal short circuits. This paper describes some efforts to introduce internal short circuit tests into safety standards.

NASA Product Peer Review Process

NASA Technical Reports Server (NTRS)

Jenks, Ken

2009-01-01

This viewgraph presentation describes NASA's product peer review process. The contents include: 1) Inspection/Peer Review at NASA; 2) Reasons for product peer reviews; 3) Different types of peer reviews; and 4) NASA requirements for peer reviews. This presentation also includes a demonstration of an actual product peer review.

Streamlining the medication process improves safety in the intensive care unit.

PubMed

Benoit, E; Eckert, P; Theytaz, C; Joris-Frasseren, M; Faouzi, M; Beney, J

2012-09-01

Multiple interventions were made to optimize the medication process in our intensive care unit (ICU). 1 Transcriptions from the medical order form to the administration plan were eliminated by merging both into a single document; 2 the new form was built in a logical sequence and was highly structured to promote completeness and standardization of information; 3 frequently used drug names, approved units, and fixed routes were pre-printed; 4 physicians and nurses were trained with regard to the correct use of the new form. This study was aimed at evaluating the impact of these interventions on clinically significant types of medication errors. Eight types of medication errors were measured by a prospective chart review before and after the interventions in the ICU of a public tertiary care hospital. We used an interrupted time-series design to control the secular trends. Over 85 days, 9298 lines of drug prescription and/or administration to 294 patients, corresponding to 754 patient-days were collected and analysed for the three series before and three series following the intervention. Global error rate decreased from 4.95 to 2.14% (-56.8%, P < 0.001). The safety of the medication process in our ICU was improved by simple and inexpensive interventions. In addition to the optimization of the prescription writing process, the documentation of intravenous preparation, and the scheduling of administration, the elimination of the transcription in combination with the training of users contributed to reducing errors and carried an interesting potential to increase safety. © 2012 The Authors. Acta Anaesthesiologica Scandinavica © 2012 The Acta Anaesthesiologica Scandinavica Foundation.

Review of quality assessment tools for the evaluation of pharmacoepidemiological safety studies

PubMed Central

Neyarapally, George A; Hammad, Tarek A; Pinheiro, Simone P; Iyasu, Solomon

2012-01-01

Objectives Pharmacoepidemiological studies are an important hypothesis-testing tool in the evaluation of postmarketing drug safety. Despite the potential to produce robust value-added data, interpretation of findings can be hindered due to well-recognised methodological limitations of these studies. Therefore, assessment of their quality is essential to evaluating their credibility. The objective of this review was to evaluate the suitability and relevance of available tools for the assessment of pharmacoepidemiological safety studies. Design We created an a priori assessment framework consisting of reporting elements (REs) and quality assessment attributes (QAAs). A comprehensive literature search identified distinct assessment tools and the prespecified elements and attributes were evaluated. Primary and secondary outcome measures The primary outcome measure was the percentage representation of each domain, RE and QAA for the quality assessment tools. Results A total of 61 tools were reviewed. Most tools were not designed to evaluate pharmacoepidemiological safety studies. More than 50% of the reviewed tools considered REs under the research aims, analytical approach, outcome definition and ascertainment, study population and exposure definition and ascertainment domains. REs under the discussion and interpretation, results and study team domains were considered in less than 40% of the tools. Except for the data source domain, quality attributes were considered in less than 50% of the tools. Conclusions Many tools failed to include critical assessment elements relevant to observational pharmacoepidemiological safety studies and did not distinguish between REs and QAAs. Further, there is a lack of considerations on the relative weights of different domains and elements. The development of a quality assessment tool would facilitate consistent, objective and evidence-based assessments of pharmacoepidemiological safety studies. PMID:23015600

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

PubMed Central

Xie, Anping; Carayon, Pascale

2014-01-01

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

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

PubMed Central

Stavropoulou, Charitini; Doherty, Carole; Tosey, Paul

2015-01-01

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

Comparison of case note review methods for evaluating quality and safety in health care.

PubMed

Hutchinson, A; Coster, J E; Cooper, K L; McIntosh, A; Walters, S J; Bath, P A; Pearson, M; Young, T A; Rantell, K; Campbell, M J; Ratcliffe, J

2010-02-01

To determine which of two methods of case note review--holistic (implicit) and criterion-based (explicit)--provides the most useful and reliable information for quality and safety of care, and the level of agreement within and between groups of health-care professionals when they use the two methods to review the same record. To explore the process-outcome relationship between holistic and criterion-based quality-of-care measures and hospital-level outcome indicators. Case notes of patients at randomly selected hospitals in England. In the first part of the study, retrospective multiple reviews of 684 case notes were undertaken at nine acute hospitals using both holistic and criterion-based review methods. Quality-of-care measures included evidence-based review criteria and a quality-of-care rating scale. Textual commentary on the quality of care was provided as a component of holistic review. Review teams comprised combinations of: doctors (n = 16), specialist nurses (n = 10) and clinically trained audit staff (n = 3) and non-clinical audit staff (n = 9). In the second part of the study, process (quality and safety) of care data were collected from the case notes of 1565 people with either chronic obstructive pulmonary disease (COPD) or heart failure in 20 hospitals. Doctors collected criterion-based data from case notes and used implicit review methods to derive textual comments on the quality of care provided and score the care overall. Data were analysed for intrarater consistency, inter-rater reliability between pairs of staff using intraclass correlation coefficients (ICCs) and completeness of criterion data capture, and comparisons were made within and between staff groups and between review methods. To explore the process-outcome relationship, a range of publicly available health-care indicator data were used as proxy outcomes in a multilevel analysis. Overall, 1473 holistic and 1389 criterion-based reviews were undertaken in the first part of the study

Improving the governance of patient safety in emergency care: a systematic review of interventions

PubMed Central

Hesselink, Gijs; Berben, Sivera; Beune, Thimpe

2016-01-01

Objectives To systematically review interventions that aim to improve the governance of patient safety within emergency care on effectiveness, reliability, validity and feasibility. Design A systematic review of the literature. Methods PubMed, EMBASE, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Database of Systematic Reviews and PsychInfo were searched for studies published between January 1990 and July 2014. We included studies evaluating interventions relevant for higher management to oversee and manage patient safety, in prehospital emergency medical service (EMS) organisations and hospital-based emergency departments (EDs). Two reviewers independently selected candidate studies, extracted data and assessed study quality. Studies were categorised according to study quality, setting, sample, intervention characteristics and findings. Results Of the 18 included studies, 13 (72%) were non-experimental. Nine studies (50%) reported data on the reliability and/or validity of the intervention. Eight studies (44%) reported on the feasibility of the intervention. Only 4 studies (22%) reported statistically significant effects. The use of a simulation-based training programme and well-designed incident reporting systems led to a statistically significant improvement of safety knowledge and attitudes by ED staff and an increase of incident reports within EDs, respectively. Conclusions Characteristics of the interventions included in this review (eg, anonymous incident reporting and validation of incident reports by an independent party) could provide useful input for the design of an effective tool to govern patient safety in EMS organisations and EDs. However, executives cannot rely on a robust set of evidence-based and feasible tools to govern patient safety within their emergency care organisation and in the chain of emergency care. Established strategies from other high-risk sectors need to be evaluated in emergency care settings, using an

Enhancing the traditional hospital design process: a focus on patient safety.

PubMed

Reiling, John G; Knutzen, Barbara L; Wallen, Thomas K; McCullough, Susan; Miller, Ric; Chernos, Sonja

2004-03-01

In 2002 St. Joseph's Community Hospital (West Bend, WI), a member of SynergyHealth, brought together leaders in health care and systems engineering to develop a set of safety-driven facility design principles that would guide the hospital design process. DESIGNING FOR SAFETY: Hospital leadership recognized that a cross-departmental team approach would be needed and formed the 11-member Facility Design Advisory Council, which, with departmental teams and the aid of architects, was responsible for overseeing the design process and for ensuring that the safety considerations were met. The design process was a team approach, with input from national experts, patients and families, hospital staff and physicians, architects, contractors, and the community. The new facility, designed using safety-driven design principles, reflects many innovative design elements, including truly standardized patient rooms, new technology to minimize falls, and patient care alcoves for every patient room. The new hospital has been designed with maximum adaptability and flexibility in mind, to accommodate changes and provide for future growth. The architects labeled the innovative design. The Synergy Model, to describe the process of shaping the entire building and its spaces to work efficiently as a whole for the care and safety of patients. Construction began on the new facility in August 2003 and is expected to be completed in 2005.

A safety review of the medications used to treat atopic dermatitis.

PubMed

Shukla, Shweta; Feldman, Steven R; Strowd, Lindsay C

2018-02-01

Atopic dermatitis (AD) is a common disease in children and adults which causes severe physical discomfort and psychosocial distress. Recently novel therapies for AD have been FDA approved for use which creates the need to review the safety surrounding current FDA approved AD medications. Areas covered: Published clinical studies involving topical and oral FDA approved medications for AD are included in this review. Authors used PubMed research database to search for clinical trials involving AD patients. Expert opinion: AD is a common disease which currently has limited FDA approved medications. Given the chronicity of this disease, medications are needed which control disease while minimizing side effects to allow for long term use. Newer approved medications show promise but safety data is limited given their relatively new utilization for AD.

Effectiveness of health and safety in small enterprises: a systematic review of quantitative evaluations of interventions.

PubMed

Breslin, F Curtis; Kyle, Natasha; Bigelow, Philip; Irvin, Emma; Morassaei, Sara; MacEachen, Ellen; Mahood, Quenby; Couban, Rachel; Shannon, Harry; Amick, Benjamin C

2010-06-01

This systematic review was conducted to identify effective occupational health and safety interventions for small businesses. The review focused on peer-reviewed intervention studies conducted in small businesses with 100 or fewer employees, that were published in English and several other languages, and that were not limited by publication date. Multidisciplinary members of the review team identified relevant articles and assessed their quality. Studies assessed as medium or high quality had data extracted, which was then synthesized. Five studies were deemed of medium or high quality, and proceeded to data extraction and evidence synthesis. The types of interventions identified: a combination of training and safety audits; and a combination of engineering, training, safety audits, and a motivational component, showed a limited amount of evidence in improving safety outcomes. Overall, this evidence synthesis found a moderate level of evidence for intervention effectiveness, and found no evidence that any intervention had adverse effects. Even though there were few studies that adequately evaluated small business intervention, several studies demonstrate that well-designed evaluations are possible with small businesses. While stronger levels of evidence are required to make recommendations, these interventions noted above were associated with positive changes in safety-related attitudes and beliefs and workplace parties should be aware of them.

Motor Carrier Safety Fitness Determination: An Improved Process

DOT National Transportation Integrated Search

1996-12-01

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

Safety of licensed vaccines in HIV-infected persons: a systematic review protocol

PubMed Central

2014-01-01

Background Safety of vaccines remains a cornerstone of building public trust on the use of these cost-effective and life-saving public health interventions. In some settings, particularly Sub-Saharan Africa, there is a high prevalence of HIV infection and a high burden of vaccine-preventable diseases. There is evidence suggesting that the immunity induced by some commonly used vaccines is not durable in HIV-infected persons, and therefore, repeated vaccination may be considered to ensure optimal vaccine-induced immunity in this population. However, some vaccines, particularly the live vaccines, may be unsafe in HIV-infected persons. There is lack of evidence on the safety profile of commonly used vaccines among HIV-infected persons. We are therefore conducting a systematic review to assess the safety profile of routine vaccines administered to HIV-infected persons. Methods/Design We will select studies conducted in any setting where licensed and effective vaccines were administered to HIV-infected persons. We will search for eligible studies in PubMed, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, Africa-Wide, PDQ-Evidence and CINAHL as well as reference lists of relevant publications. We will screen search outputs, select studies and extract data in duplicate, resolving discrepancies by discussion and consensus. Discussion Globally, immunisation is a major public health strategy to mitigate morbidity and mortality caused by various infectious disease-causing agents. In general, there are efforts to increase vaccination coverage worldwide, and for these efforts to be successful, safety of the vaccines is paramount, even among people living with HIV, who in some situations may require repeated vaccination. Results from this systematic review will be discussed in the context of the safety of routine vaccines among HIV-infected persons. From the safety perspective, we will also discuss whether repeat vaccination strategies may be

The Implementation of Payload Safety in an Operational Environment

NASA Technical Reports Server (NTRS)

Cissom, R. D.; Horvath, Tim J.; Watson, Kristi S.; Rogers, Mark N. (Technical Monitor); Vanhooser, T. (Technical Monitor)

2002-01-01

The objective of this paper is to define the safety life-cycle process for a payload beginning with the output of the Payload Safety Review Panel and continuing through the life of the payload on-orbit. It focuses on the processes and products of the operations safety implementation through the increment preparations and real-time operations processes. In addition, the paper addresses the role of the Payload Operations and Integration Center and the interfaces to the International Partner Payload Control Centers.

Safety management of complex research operators

NASA Technical Reports Server (NTRS)

Brown, W. J.

1981-01-01

Complex research and technology operations present varied potential hazards which are addressed in a disciplined, independent safety review and approval process. Potential hazards vary from high energy fuels to hydrocarbon fuels, high pressure systems to high voltage systems, toxic chemicals to radioactive materials and high speed rotating machinery to high powered lasers. A Safety Permit System presently covers about 600 potentially hazardous operations. The Safety Management Program described is believed to be a major factor in maintaining an excellent safety record.

Does classroom-based Crew Resource Management training improve patient safety culture? A systematic review

PubMed Central

de Bruijne, Martine C; Zwijnenberg, Nicolien C; Jansma, Elise P; van Dyck, Cathy; Wagner, Cordula

2014-01-01

Aim: To evaluate the evidence of the effectiveness of classroom-based Crew Resource Management training on safety culture by a systematic review of literature. Methods: Studies were identified in PubMed, Cochrane Library, PsycINFO, and Educational Resources Information Center up to 19 December 2012. The Methods Guide for Comparative Effectiveness Reviews was used to assess the risk of bias in the individual studies. Results: In total, 22 manuscripts were included for review. Training settings, study designs, and evaluation methods varied widely. Most studies reporting only a selection of culture dimensions found mainly positive results, whereas studies reporting all safety culture dimensions of the particular survey found mixed results. On average, studies were at moderate risk of bias. Conclusion: Evidence of the effectiveness of Crew Resource Management training in health care on safety culture is scarce and the validity of most studies is limited. The results underline the necessity of more valid study designs, preferably using triangulation methods. PMID:26770720

Effects of digital countdown timer on intersection safety and efficiency: A systematic review.

PubMed

Fu, Chuanyun; Zhang, Yaping; Qi, Weiwei; Cheng, Shaowu

2016-01-01

To investigate the available evidence referring to the effectiveness of digital countdown timers (DCTs) in improving the safety and operational efficiency of signalized intersection. A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement guidelines. Relevant literature was searched from electronic databases using key terms. Based on study selection and methodological quality assessment, 14 studies were included in the review. Findings of the studies were synthesized in a narrative analysis. Three types of DCT had different effects on intersection safety and operational efficiency. Green signal countdown timers (GSCTs) reduced red light violations, type I dilemma zone distributions, and rear-end collision likelihood but increased crossing after yellow onset and had mixed impacts on type II dilemma zone distributions and intersection capacity. In contrast, red signal countdown timers (RSCTs) increased intersection capacity, although their effectiveness in reducing red light violations dissipated over time. Likewise, continuous countdown timers (CCTs) significantly enhanced intersection capacity but had mixed influences on red light violations and crossing after yellow onset. Due to the limited and inconsistent evidence regarding DCTs' effects on intersection safety and efficiency, it is not sufficient to recommend any type of DCT to be installed at signalized intersections to improve safety and operational efficiency. Nevertheless, it is apparent that both RSCTs and CCTs enhance intersection capacity, though their impacts on intersection safety are unclear. Future studies need to further verify those anticipated safe and operational benefits of DCTs with enriched field observation data.

Peer review and the publication process.

PubMed

Ali, Parveen Azam; Watson, Roger

2016-10-01

To provide an overview of the peer review process, its various types, selection of peer reviewers, the purpose and significance of the peer review with regard to the assessment and management of quality of publications in academic journals. Discussion paper. This paper draws on information gained from literature on the peer review process and the authors' knowledge and experience of contributing as peer reviewers and editors in the field of health care, including nursing. There are various types of peer review: single blind; double blind; open; and post-publication review. The role of the reviewers in reviewing manuscripts and their contribution to the scientific and academic community remains important.

78 FR 4477 - Review of Safety Analysis Reports for Nuclear Power Plants, Introduction

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-22

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0268] Review of Safety Analysis Reports for Nuclear Power... Analysis Reports for Nuclear Power Plants: LWR Edition.'' The new subsection is the Standard Review Plan... Nuclear Power Plants: Integral Pressurized Water Reactor (iPWR) Edition.'' DATES: Comments must be filed...

The safety of serotonin-noradrenaline reuptake inhibitors (SNRIs) in pregnancy and breastfeeding: a comprehensive review.

PubMed

Bellantuono, Cesario; Vargas, Marianna; Mandarelli, Gabriele; Nardi, Bernardo; Martini, Maria Giulia

2015-05-01

The present study provides a comprehensive review of the existing literature on the safety of serotonin-noradrenaline reuptake inhibitors (SNRIs) in pregnancy and lactation. Studies published in English, reporting the use of SNRIs in pregnant and/or breastfeeding women, were identified by searching MEDLINE/Pubmed, PsycINFO, and EMBASE. Twenty-nine studies were included in the review. Altogether, the initial evidence coming from the reviewed studies suggests a lack of association between SNRIs and an increased risk of major congenital malformations. Conversely, exposure to SNRIs seems to be significantly associated with an increased risk of some perinatal complications. No neonatal adverse events emerged, so far, in the few studies concerning the safety of SNRIs during breastfeeding. Available data suggest that venlafaxine is relatively safe during pregnancy, in particular as far as major malformations are concerned, whereas considering the small number of studies published, no definitive conclusions can be drawn on its safety during breastfeeding. Because of the few studies so far published, the safety of duloxetine during pregnancy and breastfeeding remains to be well established. Copyright © 2015 John Wiley & Sons, Ltd.

Shelf life and safety concerns of bakery products--a review.

PubMed

Smith, James P; Daifas, Daphne Phillips; El-Khoury, Wassim; Koukoutsis, John; El-Khoury, Anis

2004-01-01

Bakery products are an important part of a balanced diet and, today, a wide variety of such products can be found on supermarket shelves. This includes unsweetened goods (bread, rolls, buns, crumpets, muffins and bagels), sweet goods (pancakes, doughnuts, waffles and cookies) and filled goods (fruit and meat pies, sausage rolls, pastries, sandwiches, cream cakes, pizza and quiche). However, bakery products, like many processed foods, are subject to physical, chemical and microbiological spoilage. While physical and chemical spoilage limits the shelf life of low and intermediate moisture bakery products, microbiological spoilage by bacteria, yeast and molds is the concern in high moisture products i.e., products with a water activity (a(w)) > 0.85. Furthermore, several bakery products also have been implicated infoodborne illnesses involving Salmonella spp., Listeria monoctyogenes and Bacillus cereus, while Clostridium botulinum is a concern in high moisture bakery products packaged under modified atmospheres. This extensive review is divided into two parts. Part I focuses on the spoilage concerns of low, intermediate and high moisture bakery products while Part II focuses on the safety concerns of high moisture bakery products only. In both parts, traditional and novel methods of food preservation that can be used by the bakery industry to extend the shelf life and enhance the safety of products are discussed in detail.

Safety of human papillomavirus vaccines: a review.

PubMed

Macartney, Kristine K; Chiu, Clayton; Georgousakis, Melina; Brotherton, Julia M L

2013-06-01

Vaccination to prevent human papillomavirus (HPV)-related infection leading to cancer, particularly cervical cancer, is a major public health breakthrough. There are currently two licensed HPV vaccines, both of which contain recombinant virus-like particles of HPV types 16 and 18 (which account for approximately 70 % of cervical cancer). One vaccine also protects against HPV types 6 and 11, which cause genital warts. The safety profile of both vaccines was assessed extensively in randomised controlled clinical trials conducted prior to licensure and has been further elucidated following licensure from surveillance and specific studies in large populations. This review aims to examine current evidence regarding the safety of HPV vaccines. In summary, both vaccines are associated with relatively high rates of injection site reactions, particularly pain, but this is usually of short duration and resolves spontaneously. Systemic reactions have generally been mild and self-limited. Post vaccination syncope has occurred, but can be avoided with appropriate care. Serious vaccine-attributable adverse events, such as anaphylaxis, are rare, and although not recommended for use in pregnancy, abnormal pregnancy outcomes following inadvertent administration do not appear to be associated with vaccination. HPV vaccines are used in a three-dose schedule predominantly in adolescent females: as such case reports linking vaccination with a range of new onset chronic conditions, including autoimmune diseases, have been made. However, well-conducted population-based studies show no association between HPV vaccine and a range of such conditions. Whilst this reassuring safety profile affirms the positive risk benefit of vaccination, as HPV vaccine use expands into more diverse populations, including males, ongoing safety assessment using well-conducted studies is appropriate.

Information Scanning and Processing at the Nuclear Safety Information Center.

ERIC Educational Resources Information Center

Parks, Celia; Julian, Carol

This report is a detailed manual of the information specialist's duties at the Nuclear Safety Information Center. Information specialists scan the literature for documents to be reviewed, procure the documents (books, journal articles, reports, etc.), keep the document location records, and return the documents to the plant library or other…

Women's journey to safety - the Transtheoretical model in clinical practice when working with women experiencing Intimate Partner Violence: a scientific review and clinical guidance.

PubMed

Reisenhofer, Sonia; Taft, Angela

2013-12-01

Review the applicability of the Transtheoretical model and provide updated guidance for clinicians working with women experiencing intimate partner violence. Critical review of related primary research conducted from 1990 to March 2013. Women's experiences of creating change within abusive relationships can be located within a stages of change continuum by identifying dominant behavioral clusters. The processes of change and constructs of decisional-balance and turning-points are evident in women's decision-making when they engage in change. Clinicians can use the stages of change to provide a means of assessing women's movement toward their nominated outcomes, and the processes of change, decisional-balance and turning-points, to enhance understanding of, and promote women's movement across stages in their journey to safety. Clinicians should assess women individually for immediate and ongoing safety and well-being, and identify their overarching stage of change. Clinicians can support women in identifying and implementing their personal objectives to enhance self-efficacy and create positive change movement across stages. The three primary objectives identified for clinician support are: 1. Minimizing harm and promoting well-being within an abusive relationship, 2. Achieving safety and well-being within the relationship; halting the abuse, or 3. Achieving safety by ending/leaving intimate relationships. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Critical review of the current literature on the safety of sucralose.

PubMed

Magnuson, Bernadene A; Roberts, Ashley; Nestmann, Earle R

2017-08-01

Sucralose is a non-caloric high intensity sweetener that is approved globally for use in foods and beverages. This review provides an updated summary of the literature addressing the safety of use of sucralose. Studies reviewed include chemical characterization and stability, toxicokinetics in animals and humans, assessment of genotoxicity, and animal and human feeding studies. Endpoints evaluated include effects on growth, development, reproduction, neurotoxicity, immunotoxicity, carcinogenicity and overall health status. Human clinical studies investigated potential effects of repeated consumption in individuals with diabetes. Recent studies on the safety of sucralose focused on carcinogenic potential and the effect of sucralose on the gut microflora are reviewed. Following the discovery of sweet taste receptors in the gut and studies investigating the activation of these receptors by sucralose lead to numerous human clinical studies assessing the effect of sucralose on overall glycemic control. Estimated daily intakes of sucralose in different population subgroups, including recent studies on children with special dietary needs, consistently find that the intakes of sucralose in all members of the population remain well below the acceptable daily intake. Collectively, critical review of the extensive database of research demonstrates that sucralose is safe for its intended use as a non-caloric sugar alternative. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Safety and risks of nitrous oxide labor analgesia: a review.

PubMed

Rooks, Judith P

2011-01-01

This review of the safety and risks of nitrous oxide (N(2) O) labor analgesia presents results of a search for evidence of its effects on labor, the mother, the fetus, the neonate, breastfeeding, and maternal-infant bonding. Concerns about apoptotic damage to the brains of immature mammals exposed to high doses of N(2) O during late gestation, possible cardiovascular risks from hyperhomocysteinemia caused by N(2) O, a hypothesis that children exposed to N(2) O during birth are more likely to become addicted to amphetamine drugs as adults, and possible occupational risks for those who provide care to women using N(2) O/O(2) labor analgesia are discussed in detail. Research relevant to the 4 special concerns and to the effects of N(2) O analgesia on labor and the mother-child dyad were examined in depth. Three recent reviews of the biologic, toxicologic, anesthetic, analgesic, and anxiolytic effects of N(2) O; 3 reviews of the safety of 50% N(2) O/oxygen (O(2) ) in providing analgesia in a variety of health care settings; and a 2002 systematic review of N(2) O/O(2) labor analgesia were used. Nitrous oxide analgesia is safe for mothers, neonates, and those who care for women during childbirth if the N(2) O is delivered as a 50% blend with O(2) , is self-administered, and good occupational hygiene is practiced. Because of the strong correlation between dose and harm from exposure to N(2) O, concerns based on effects of long exposure to high anesthetic-level doses of N(2) O have only tenuous, hypothetical pertinence to the safety of N(2) O/O(2) labor analgesia. Nitrous oxide labor analgesia is safe for the mother, fetus, and neonate and can be made safe for caregivers. It is simple to administer, does not interfere with the release and function of endogenous oxytocin, and has no adverse effects on the normal physiology and progress of labor. © 2011 by the American College of Nurse-Midwives.

Driver inattention and highway safety

DOT National Transportation Integrated Search

1985-01-14

The Transportation Systems Center, in support of research carried out by the : National Highway Traffic Safety Administration's Crash Avoidance Division, has : reviewed research into driver attentional processes to assess the potential for : the deve...

Driver inattention and highway safety

DOT National Transportation Integrated Search

1985-01-01

The Transportation Systems Center, in support of research carried out by the National Highway Traffic Safety Administration's Crash Avoidance Division, has reviewed research into driver attentional processes to assess the potential for the developmen...

Improving Patient Safety Culture in Primary Care: A Systematic Review.

PubMed

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

2016-09-01

Patient safety culture, described as shared values, attitudes and behavior of staff in a health-care organization, gained attention as a subject of study as it is believed to be related to the impact of patient safety improvements. However, in primary care, it is yet unknown, which effect interventions have on the safety culture. To review literature on the use of interventions that effect patient safety culture in primary care. Searches were performed in PubMed, EMBASE, CINAHL, and PsychINFO on March 4, 2013. Terms defining safety culture were combined with terms identifying intervention and terms indicating primary care. Inclusion followed if the intervention effected patient safety culture, and effect measures were reported. The search yielded 214 articles from which two were eligible for inclusion. Both studies were heterogeneous in their interventions and outcome; we present a qualitative summary. One study described the implementation of an electronic medical record system in general practices as part of patient safety improvements. The other study facilitated 2 workshops for general practices, one on risk management and another on significant event audit. Results showed signs of improvement, but the level of evidence was low because of the design and methodological problems. These studies in general practice provide a first understanding of improvement strategies and their effect in primary care. As the level of evidence was low, no clear preference can be determined. Further research is needed to help practices make an informed choice for an intervention.

[Patient safety in home care - A review of international recommendations].

PubMed

Czakert, Judith; Lehmann, Yvonne; Ewers, Michael

2018-06-08

In recent years there has been a growing trend towards nursing care at home in general as well as towards intensive home care being provided by specialized home care services in Germany. However, resulting challenges for patient safety have rarely been considered. Against this background we aimed to explore whether international recommendations for patient safety in home care in general and in intensive home care in particular already exist and how they can stimulate further practice development in Germany. A review of online English documents containing recommendations for patient safety in intensive home care was conducted. Available documents were analyzed and compared in terms of their form and content. Overall, a small number of relevant documents could be identified. None of these documents exclusively refer to the intensive home care sector. Despite their differences, however, the analysis of four selected documents showed similarities, e. g., regarding specific topics of patient safety (communication, involvement of patients and their relatives, risk assessment, medication management, qualification). Furthermore, strengths and weaknesses of the documents became apparent: e. g., an explicit understanding of patient safety, a literature-based introduction to safety topics or an adaptation of the recommendations to the specific features of home care were occasionally lacking. This document analysis provides interesting input to the formal and content-related development of specific recommendations and to practice development in Germany to improve patient safety in home care. Copyright © 2018. Published by Elsevier GmbH.

Findings of a review of spacecraft fire safety needs

NASA Technical Reports Server (NTRS)

Apostolakis, G. E.; Catton, I.; Paulos, T.; Paxton, K.; Jones, S.

1992-01-01

Discussions from a workshop to guide UCLA and NASA investigators on the state of knowledge and perceived needs in spacecraft fire safety and its risk management are reviewed, for an introduction to an analytical and experimental project in this field. The report summarizes the workshop discussions and includes the visual aids used in the presentations. Probabilistic Safety Assessment (PSA) methods, which are currently not used, would be of great value to the designs and operation of future human-crew spacecraft. Key points in the discussions were the importance of understanding and testing smoldering as a likely fire scenario in space and the need for smoke damage modeling, since many fire-risk models ignore this mechanism and consider only heat damage.

Standardized languages and notations for graphical modelling of patient care processes: a systematic review.

PubMed

Mincarone, Pierpaolo; Leo, Carlo Giacomo; Trujillo-Martín, Maria Del Mar; Manson, Jan; Guarino, Roberto; Ponzini, Giuseppe; Sabina, Saverio

2018-04-01

The importance of working toward quality improvement in healthcare implies an increasing interest in analysing, understanding and optimizing process logic and sequences of activities embedded in healthcare processes. Their graphical representation promotes faster learning, higher retention and better compliance. The study identifies standardized graphical languages and notations applied to patient care processes and investigates their usefulness in the healthcare setting. Peer-reviewed literature up to 19 May 2016. Information complemented by a questionnaire sent to the authors of selected studies. Systematic review conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Five authors extracted results of selected studies. Ten articles met the inclusion criteria. One notation and language for healthcare process modelling were identified with an application to patient care processes: Business Process Model and Notation and Unified Modeling Language™. One of the authors of every selected study completed the questionnaire. Users' comprehensibility and facilitation of inter-professional analysis of processes have been recognized, in the filled in questionnaires, as major strengths for process modelling in healthcare. Both the notation and the language could increase the clarity of presentation thanks to their visual properties, the capacity of easily managing macro and micro scenarios, the possibility of clearly and precisely representing the process logic. Both could increase guidelines/pathways applicability by representing complex scenarios through charts and algorithms hence contributing to reduce unjustified practice variations which negatively impact on quality of care and patient safety.

ASCERTAINMENT OF ON-ROAD SAFETY ERRORS BASED ON VIDEO REVIEW

PubMed Central

Dawson, Jeffrey D.; Uc, Ergun Y.; Anderson, Steven W.; Dastrup, Elizabeth; Johnson, Amy M.; Rizzo, Matthew

2011-01-01

Summary Using an instrumented vehicle, we have studied several aspects of the on-road performance of healthy and diseased elderly drivers. One goal from such studies is to ascertain the type and frequency of driving safety errors. Because the judgment of such errors is somewhat subjective, we applied a taxonomy system of 15 general safety error categories and 76 specific safety error types. We also employed and trained professional driving instructors to review the video data of the on-road drives. In this report, we illustrate our rating system on a group of 111 drivers, ages 65 to 89. These drivers made errors in 13 of the 15 error categories, comprising 42 of the 76 error types. A mean (SD) of 35.8 (12.8) safety errors per drive were noted, with 2.1 (1.7) of them being judged as serious. Our methodology may be useful in applications such as intervention studies, and in longitudinal studies of changes in driving abilities in patients with declining cognitive ability. PMID:24273753

Healthcare quality and safety: a review of policy, practice and research.

PubMed

Waring, Justin; Allen, Davina; Braithwaite, Jeffrey; Sandall, Jane

2016-02-01

Over the last two decades healthcare quality and safety have risen to the fore of health policy and research. This has largely been informed by theoretical and empirical ideas found in the fields of ergonomics and human factors. These have enabled significant advances in our understanding and management of quality and safety. However, a parallel and at time neglected sociological literature on clinical quality and safety is presented as offering additional, complementary, and at times critical insights on the problems of quality and safety. This review explores the development and contributions of both the mainstream and more sociological approaches to safety. It shows that where mainstream approaches often focus on the influence of human and local environment factors in shaping quality, a sociological perspective can deepen knowledge of the wider social, cultural and political factors that contextualise the clinical micro-system. It suggests these different perspectives can easily complement one another, offering a more developed and layered understanding of quality and safety. It also suggests that the sociological literature can bring to light important questions about the limits of the more mainstream approaches and ask critical questions about the role of social inequality, power and control in the framing of quality and safety. © 2015 Foundation for the Sociology of Health & Illness.

The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System.

PubMed

Keyter, Andrea; Gouws, Joey; Salek, Sam; Walker, Stuart

2018-01-01

The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, transparency, timeliness, and predictability in the review process; and to provide recommendations for enhanced regulatory practices. A questionnaire was completed by the Medicines Control Council (MCC) to describe the organization of the authority, record key milestones and timelines in the review process and to identify good review practices (GRevPs). Currently, the MCC conducts a full assessment of quality, efficacy, and safety data in the review of all applications. The overall regulatory median approval time decreased by 14% in 2017 (1411 calendar days) compared with that of 2016, despite the 27% increase in the number of applications. However, the MCC has no target for overall approval time of new active substance applications and no targets for key review milestones. Guidelines, standard operating procedures, and review templates are in place, while the formal implementation of GRevPs and the application of an electronic document management system are planned for the near future. As the MCC transitions to the newly established South Africa Health Products Regulatory Authority, it would be crucial for the authority to recognize the opportunities for an enhanced regulatory review and should consider models such as abridged assessment, which encompass elements of risk stratification and reliance. It is hoped that resource constraints may then be alleviated and capacity developed to meet target timelines.

Xylitol: a review on bioproduction, application, health benefits, and related safety issues.

PubMed

Ur-Rehman, Salim; Mushtaq, Zarina; Zahoor, Tahir; Jamil, Amir; Murtaza, Mian Anjum

2015-01-01

Xylitol is a pentahydroxy sugar-alcohol which exists in a very low quantity in fruits and vegetables (plums, strawberries, cauliflower, and pumpkin). On commercial scale, xylitol can be produced by chemical and biotechnological processes. Chemical production is costly and extensive in purification steps. However, biotechnological method utilizes agricultural and forestry wastes which offer the possibilities of economic production of xylitol by reducing required energy. The precursor xylose is produced from agricultural biomass by chemical and enzymatic hydrolysis and can be converted to xylitol primarily by yeast strain. Hydrolysis under acidic condition is the more commonly used practice influenced by various process parameters. Various fermentation process inhibitors are produced during chemical hydrolysis that reduce xylitol production, a detoxification step is, therefore, necessary. Biotechnological xylitol production is an integral process of microbial species belonging to Candida genus which is influenced by various process parameters such as pH, temperature, time, nitrogen source, and yeast extract level. Xylitol has application and potential for food and pharmaceutical industries. It is a functional sweetener as it has prebiotic effects which can reduce blood glucose, triglyceride, and cholesterol level. This review describes recent research developments related to bioproduction of xylitol from agricultural wastes, application, health, and safety issues.

CRITICALITY SAFETY CONTROLS AND THE SAFETY BASIS AT PFP

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

Kessler, S

2009-04-21

With the implementation of DOE Order 420.1B, Facility Safety, and DOE-STD-3007-2007, 'Guidelines for Preparing Criticality Safety Evaluations at Department of Energy Non-Reactor Nuclear Facilities', a new requirement was imposed that all criticality safety controls be evaluated for inclusion in the facility Documented Safety Analysis (DSA) and that the evaluation process be documented in the site Criticality Safety Program Description Document (CSPDD). At the Hanford site in Washington State the CSPDD, HNF-31695, 'General Description of the FH Criticality Safety Program', requires each facility develop a linking document called a Criticality Control Review (CCR) to document performance of these evaluations. Chapter 5,more » Appendix 5B of HNF-7098, Criticality Safety Program, provided an example of a format for a CCR that could be used in lieu of each facility developing its own CCR. Since the Plutonium Finishing Plant (PFP) is presently undergoing Deactivation and Decommissioning (D&D), new procedures are being developed for cleanout of equipment and systems that have not been operated in years. Existing Criticality Safety Evaluations (CSE) are revised, or new ones written, to develop the controls required to support D&D activities. Other Hanford facilities, including PFP, had difficulty using the basic CCR out of HNF-7098 when first implemented. Interpretation of the new guidelines indicated that many of the controls needed to be elevated to TSR level controls. Criterion 2 of the standard, requiring that the consequence of a criticality be examined for establishing the classification of a control, was not addressed. Upon in-depth review by PFP Criticality Safety staff, it was not clear that the programmatic interpretation of criterion 8C could be applied at PFP. Therefore, the PFP Criticality Safety staff decided to write their own CCR. The PFP CCR provides additional guidance for the evaluation team to use by clarifying the evaluation criteria in DOE-STD-3007

Concise Review: Process Development Considerations for Cell Therapy

PubMed Central

Brieva, Thomas; Raviv, Lior; Rowley, Jon; Niss, Knut; Brandwein, Harvey; Oh, Steve; Karnieli, Ohad

2015-01-01

The development of robust and well-characterized methods of production of cell therapies has become increasingly important as therapies advance through clinical trials toward approval. A successful cell therapy will be a consistent, safe, and effective cell product, regardless of the cell type or application. Process development strategies can be developed to gain efficiency while maintaining or improving safety and quality profiles. This review presents an introduction to the process development challenges of cell therapies and describes some of the tools available to address production issues. This article will provide a summary of what should be considered to efficiently advance a cellular therapy from the research stage through clinical trials and finally toward commercialization. The identification of the basic questions that affect process development is summarized in the target product profile, and considerations for process optimization are discussed. The goal is to identify potential manufacturing concerns early in the process so they may be addressed effectively and thus increase the probability that a therapy will be successful. Significance The present study contributes to the field of cell therapy by providing a resource for those transitioning a potential therapy from the research stage to clinical and commercial applications. It provides the necessary steps that, when followed, can result in successful therapies from both a clinical and commercial perspective. PMID:26315572

Model Transformation for a System of Systems Dependability Safety Case

NASA Technical Reports Server (NTRS)

Murphy, Judy; Driskell, Steve

2011-01-01

The presentation reviews the dependability and safety effort of NASA's Independent Verification and Validation Facility. Topics include: safety engineering process, applications to non-space environment, Phase I overview, process creation, sample SRM artifact, Phase I end result, Phase II model transformation, fault management, and applying Phase II to individual projects.

A systematic literature review of the effectiveness of occupational health and safety regulatory enforcement.

PubMed

Tompa, Emile; Kalcevich, Christina; Foley, Michael; McLeod, Chris; Hogg-Johnson, Sheilah; Cullen, Kim; MacEachen, Ellen; Mahood, Quenby; Irvin, Emma

2016-11-01

We aimed to determine the strength of evidence on the effectiveness of legislative and regulatory policy levers in creating incentives for organizations to improve occupational health and safety processes and outcomes. A systematic review was undertaken to assess the strength of evidence on the effectiveness of specific policy levers using a "best-evidence" synthesis approach. A structured literature search identified 11,947 citations from 13 peer-reviewed literature databases. Forty-three studies were retained for synthesis. Strong evidence was identified for three out of nine clusters. There is strong evidence that several OHS policy levers are effective in terms of reducing injuries and/or increasing compliance with legislation. This study adds to the evidence on OHS regulatory effectiveness from an earlier review. In addition to new evidence supporting previous study findings, it included new categories of evidence-compliance as an outcome, nature of enforcement, awareness campaigns, and smoke-free workplace legislation. Am. J. Ind. Med. 59:919-933, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

A Review of Research on Procedures for Teaching Safety Skills to Persons with Developmental Disabilities

ERIC Educational Resources Information Center

Dixon, Dennis R.; Bergstrom, Ryan; Smith, Marlena N.; Tarbox, Jonathan

2010-01-01

Safety skills are an important but often neglected area of training for persons with developmental disabilities (DD). The present study reviewed the literature on teaching safety skills to persons with DD. Safety skills involve a variety of behaviors such as knowing how to cross the street or what to do in case of a house fire. A number of studies…

77 FR 50723 - Verification, Validation, Reviews, and Audits for Digital Computer Software Used in Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-22

... Digital Computer Software Used in Safety Systems of Nuclear Power Plants AGENCY: Nuclear Regulatory..., ``Verification, Validation, Reviews, and Audits for Digital Computer Software used in Safety Systems of Nuclear... NRC regulations promoting the development of, and compliance with, software verification and...

Risk management systems for health care and safety development on transplantation: a review and a proposal.

PubMed

Pretagostini, R; Gabbrielli, F; Fiaschetti, P; Oliveti, A; Cenci, S; Peritore, D; Stabile, D

2010-05-01

Starting from the report on medical errors published in 1999 by the US Institute of Medicine, a number of different approaches to risk management have been developed for maximum risk reduction in health care activities. The health care authorities in many countries have focused attention on patient safety, employing action research programs that are based on quite different principles. We performed a systematic Medline research of the literature since 1999. The following key words were used, also combining boolean operators and medical subheading terms: "adverse event," "risk management," "error," and "governance." Studies published in the last 5 years were particularly classified in various groups: risk management in health care systems; safety in specific hospital activities; and health care institutions' official documents. Methods of action researches have been analysed and their characteristics compared. Their suitability for safety development in donation, retrieval, and transplantation processes were discussed in the reality of the Italian transplant network. Some action researches and studies were dedicated to entire national healthcare systems, whereas others focused on specific risks. Many research programs have undergone critical review in the literature. Retrospective analysis has centered on so-called sentinel events to particularly analyze only a minor portion of the organizational phenomena, which can be the origin of an adverse event, an incident, or an error. Sentinel events give useful information if they are studied in highly engineered and standardized organizations like laboratories or tissue establishments, but they show several limits in the analysis of organ donation, retrieval, and transplantation processes, which are characterized by prevailing human factors, with high intrinsic risk and variability. Thus, they are poorly effective to deliver sure elements to base safety management improvement programs, especially regarding

Process value of care safety: women's willingness to pay for perinatal services.

PubMed

Anezaki, Hisataka; Hashimoto, Hideki

2017-08-01

To evaluate the process value of care safety from the patient's view in perinatal services. Cross-sectional survey. Fifty two sites of mandated public neonatal health checkup in 6 urban cities in West Japan. Mothers who attended neonatal health checkups for their babies in 2011 (n = 1316, response rate = 27.4%). Willingness to pay (WTP) for physician-attended care compared with midwife care as the process-related value of care safety. WTP was estimated using conjoint analysis based on the participants' choice over possible alternatives that were randomly assigned from among eight scenarios considering attributes such as professional attendance, amenities, painless delivery, caesarean section rate, travel time and price. The WTP for physician-attended care over midwife care was estimated 1283 USD. Women who had experienced complications in prior deliveries had a 1.5 times larger WTP. We empirically evaluated the process value for safety practice in perinatal care that was larger than a previously reported accounting-based value. Our results indicate that measurement of process value from the patient's view is informative for the evaluation of safety care, and that it is sensitive to individual risk perception for the care process. © The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care.

42 CFR 457.1140 - Program specific review process: Core elements of review.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 4 2011-10-01 2011-10-01 false Program specific review process: Core elements of review. 457.1140 Section 457.1140 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF... review process: Core elements of review. In adopting the procedures for review of matters described in...

42 CFR 457.1140 - Program specific review process: Core elements of review.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Program specific review process: Core elements of review. 457.1140 Section 457.1140 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF... review process: Core elements of review. In adopting the procedures for review of matters described in...

Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications.

PubMed

Chang, Lin-Chau; Mahmood, Riaz; Qureshi, Samina; Breder, Christopher D

2017-01-01

Standardised MedDRA Queries (SMQs) have been developed since the early 2000's and used by academia, industry, public health, and government sectors for detecting safety signals in adverse event safety databases. The purpose of the present study is to characterize how SMQs are used and the impact in safety analyses for New Drug Application (NDA) and Biologics License Application (BLA) submissions to the United States Food and Drug Administration (USFDA). We used the PharmaPendium database to capture SMQ use in Summary Basis of Approvals (SBoAs) of drugs and biologics approved by the USFDA. Characteristics of the drugs and the SMQ use were employed to evaluate the role of SMQ safety analyses in regulatory decisions and the veracity of signals they revealed. A comprehensive search of the SBoAs yielded 184 regulatory submissions approved from 2006 to 2015. Search strategies more frequently utilized restrictive searches with "narrow terms" to enhance specificity over strategies using "broad terms" to increase sensitivity, while some involved modification of search terms. A majority (59%) of 1290 searches used descriptive statistics, however inferential statistics were utilized in 35% of them. Commentary from reviewers and supervisory staff suggested that a small, yet notable percentage (18%) of 1290 searches supported regulatory decisions. The searches with regulatory impact were found in 73 submissions (40% of the submissions investigated). Most searches (75% of 227 searches) with regulatory implications described how the searches were confirmed, indicating prudence in the decision-making process. SMQs have an increasing role in the presentation and review of safety analysis for NDAs/BLAs and their regulatory reviews. This study suggests that SMQs are best used for screening process, with descriptive statistics, description of SMQ modifications, and systematic verification of cases which is crucial for drawing regulatory conclusions.

Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications

PubMed Central

Chang, Lin-Chau; Mahmood, Riaz; Qureshi, Samina

2017-01-01

Purpose Standardised MedDRA Queries (SMQs) have been developed since the early 2000’s and used by academia, industry, public health, and government sectors for detecting safety signals in adverse event safety databases. The purpose of the present study is to characterize how SMQs are used and the impact in safety analyses for New Drug Application (NDA) and Biologics License Application (BLA) submissions to the United States Food and Drug Administration (USFDA). Methods We used the PharmaPendium database to capture SMQ use in Summary Basis of Approvals (SBoAs) of drugs and biologics approved by the USFDA. Characteristics of the drugs and the SMQ use were employed to evaluate the role of SMQ safety analyses in regulatory decisions and the veracity of signals they revealed. Results A comprehensive search of the SBoAs yielded 184 regulatory submissions approved from 2006 to 2015. Search strategies more frequently utilized restrictive searches with “narrow terms” to enhance specificity over strategies using “broad terms” to increase sensitivity, while some involved modification of search terms. A majority (59%) of 1290 searches used descriptive statistics, however inferential statistics were utilized in 35% of them. Commentary from reviewers and supervisory staff suggested that a small, yet notable percentage (18%) of 1290 searches supported regulatory decisions. The searches with regulatory impact were found in 73 submissions (40% of the submissions investigated). Most searches (75% of 227 searches) with regulatory implications described how the searches were confirmed, indicating prudence in the decision-making process. Conclusions SMQs have an increasing role in the presentation and review of safety analysis for NDAs/BLAs and their regulatory reviews. This study suggests that SMQs are best used for screening process, with descriptive statistics, description of SMQ modifications, and systematic verification of cases which is crucial for drawing regulatory

Review article: practical current issues in perioperative patient safety.

PubMed

Eichhorn, John H

2013-02-01

This brief review provides an overview and, importantly, a context perspective of relevant current practical issues in perioperative patient safety. The dramatic improvement in anesthesia patient safety over the last 30 years was not initiated by electronic monitors but, rather, largely by a set of behaviours known as "safety monitoring" that were then made decidedly more effective by extending the human senses through electronic monitoring, for example, capnography and pulse oximetry. In the highly developed world, this current success is threatened by complacency and production pressure. In some areas of the developing/underdeveloped world, the challenge is implementing the components of anesthesia practice that will bring safety improvements to parallel the overall current success, for instance, applying the World Federation of Societies of Anaesthesiologists (WFSA) "International Standards for A Safe Practice of Anaesthesia". Generally, expanding the current success in safety involves many practical issues. System issues involve research, effective reporting mechanisms and analysis/broadcasting of results, perioperative communication (including "speaking up to power"), and checklists. Monitoring issues involve enforcing existing published monitoring standards and also recognizing the risk of danger to the patient from hypoventilation during procedural sedation and from postoperative intravenous pain medications. Issues of clinical care include medication errors in the operating room, cerebral hypoperfusion (especially in the head-up position), dangers of airway management, postoperative residual weakness from muscle relaxants, operating room fires, and risks specific in obstetric anesthesia. Recognition of the issues outlined here and empowerment of all anesthesia professionals, from the most senior professors and administrators to the newest practitioners, should help maintain, solidify, and expand the improvements in anesthesia and perioperative patient

Building Collaboration: A Scoping Review of Cultural Competency and Safety Education and Training for Healthcare Students and Professionals in Canada.

PubMed

Guerra, Olivia; Kurtz, Donna

2017-01-01

Phenomenon: This scoping literature review summarizes current Canadian health science education and training aimed to lessen health gaps between Aboriginal and non-Aboriginal peoples. Keyword searches of peer-reviewed and gray literature databases, websites, and resources recommended by local Aboriginal community members identified 1,754 resources. Using specific inclusion and exclusion criteria, 26 resources relevant to education and training of healthcare professionals and students in Canada were selected. Information included self-assessment for cultural competency/safety skills, advocacy within Canadian healthcare, and descriptions of current programs and training approaches. In spite of increasing awareness and use of cultural competency and safety concepts, few programs have been successfully implemented. Insights: A concerted effort among health science education and training bodies to develop integrated and effective programs could result in comprehensive processes that hasten the Canadian culturally safe healthcare provision, thus reducing the gaps among populations.

78 FR 32010 - Pipeline Safety: Public Workshop on Integrity Verification Process

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-28

.... PHMSA-2013-0119] Pipeline Safety: Public Workshop on Integrity Verification Process AGENCY: Pipeline and... announcing a public workshop to be held on the concept of ``Integrity Verification Process.'' The Integrity Verification Process shares similar characteristics with fitness for service processes. At this workshop, the...

Selection of Surrogate Bacteria for Use in Food Safety Challenge Studies: A Review.

PubMed

Hu, Mengyi; Gurtler, Joshua B

2017-09-01

Nonpathogenic surrogate bacteria are prevalently used in a variety of food challenge studies in place of foodborne pathogens such as Listeria monocytogenes, Salmonella, Escherichia coli O157:H7, and Clostridium botulinum because of safety and sanitary concerns. Surrogate bacteria should have growth characteristics and/or inactivation kinetics similar to those of target pathogens under given conditions in challenge studies. It is of great importance to carefully select and validate potential surrogate bacteria when verifying microbial inactivation processes. A validated surrogate responds similar to the targeted pathogen when tested for inactivation kinetics, growth parameters, or survivability under given conditions in agreement with appropriate statistical analyses. However, a considerable number of food studies involving putative surrogate bacteria lack convincing validation sources or adequate validation processes. Most of the validation information for surrogates in these studies is anecdotal and has been collected from previous publications but may not be sufficient for given conditions in the study at hand. This review is limited to an overview of select studies and discussion of the general criteria and approaches for selecting potential surrogate bacteria under given conditions. The review also includes a list of documented bacterial pathogen surrogates and their corresponding food products and treatments to provide guidance for future studies.

Jurisdiction to review agency nonenforcement under the Federal Mine Safety and Health Act: the miner as litigant

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

Yun, J.S.

This article discusses the legal issues presented by an attempt to obtain judicial review of the Mine Safety and Health Administration's (MSHA) failure to enforce the Federal Mine Safety and Health Amendments Act of 1977. The focus is on what jurisdictional barriers confront the beneficiary or protected party or a remedial statute who tries to compel unlawfully withheld agency enforcement. The courts have generally failed to distinguish either the statutory interests of the protected party versus the regulated party or their intended roles in the statutory decision-making process. They apply the exhaustion requirement and exclusivity of remedies principle in amore » mechanical fashion. In the future, courts can focus instead upon the benefits and burdens to the statutory scheme entailed by their assumption or denial of jurisdiction. 214 references.« less

DOE explosives safety manual

NASA Astrophysics Data System (ADS)

1990-05-01

The Department of Energy (DOE) policy requires that all activities be conducted in a manner that protects the safety of the public and provides a safe and healthful workplace for employees. DOE has also prescribed that all personnel be protected in any explosives operation undertaken. The level of safety provided shall be at least equivalent to that of the best industrial practice. The risk of death or serious injury shall be limited to the lowest practicable minimum. DOE and contractors shall continually review their explosives operations with the aim of achieving further refinements and improvements in safety practices and protective features. This manual describes the Department's explosive safety requirements applicable to operations involving the development, testing, handling, and processing of explosives or assemblies containing explosives. It is intended to reflect the state-of-the-art in explosives safety. In addition, it is essential that applicable criteria and requirements for implementing this policy be readily available and known to those responsible for conducting DOE programs. This document shall be periodically reviewed and updated to establish new requirements as appropriate. Users are requested to submit suggestions for improving the DOE Explosives Safety Manual through their appropriate Operations Office to the Office of Quality Programs.

Centralized drug review processes: are they fair?

PubMed

Mitton, Craig R; McMahon, Meghan; Morgan, Steve; Gibson, Jennifer

2006-07-01

Numerous countries have implemented centralized drug review processes to assist in making drug coverage decisions. In addition to examining the final recommendations of these bodies, it is also important to ensure fairness in decision making. Accountability for reasonableness is an ethics-based framework for examining the fairness of priority setting processes. The objective of this study was to assess the fairness of four internationally established centralized drug review processes using accountability for reasonableness. Semi-structured telephone interviews were conducted with stakeholders in Canada, New Zealand, Australia and the UK (n=16). Participants were asked to evaluate their country's centralized drug review process against the four conditions of accountability for reasonableness. Each centralized drug review process satisfied at least one of the four ethical conditions, but none satisfied all four conditions. All participants viewed transparency as critical to both the legitimacy and fairness of centralized drug review processes. Additional strides need to be made in each of the four countries under study to improve the fairness of their centralized drug review processes. Ideally, a fair priority setting process should foster constructive stakeholder engagement and enhance the legitimacy of decisions made in assessing pharmaceutical products for funding. As policy makers are under increasing scrutiny in allocating limited resources, fair process should be seen as a critical component of such activity. This study represents the first attempt to conduct an international comparison of the fairness of centralized drug review agencies in the eyes of participating stakeholders.

FMCSA safety program effectiveness measurement : compliance review effectiveness model results for carriers with compliance reviews in FY 2008

DOT National Transportation Integrated Search

2012-09-30

In FY 2008, Federal and State enforcement personnel conducted 14,906 compliance reviews (CRs) on individual motor carriers. It is intended that through education, heightened safety regulation awareness, and the enforcement effects of the CR, carriers...

Use of patient safety culture instruments in operating rooms: A systematic literature review.

PubMed

Zhao, Pujng; Li, Yaqin; Li, Zhi; Jia, Pengli; Zhang, Longhao; Zhang, Mingming

2017-05-01

To identify and qualitatively describe, in a literature review, how the instruments were used to evaluate patient safety culture in the operating rooms of published studies. Systematic searches of the literature were conducted using the major database including MEDLINE, EMbase, The Cochrane Library, and four Chinese databases including Chinese Biomedical Literature Database (CBM), Wanfang Data, Chinese Scientific Journal Database (VIP), and Chinese Journals Full-text Database (CNKI) for studies published up to March 2016. We summarized and analyzed the country scope, the instrument utilized in the study, the year when the instrument was used, and fields of operating rooms. Study populations, study settings, and the time span between baseline and follow-up phase were evaluated according to the study design. We identified 1025 references, of which 99 were obtained for full-text assessment; 47 of these studies were deemed relevant and included in the literature review. Most of the studies were from the USA. The most commonly used patient safety culture instrument was Safety Attitude Questionnaire. All identified instruments were used after 2002 and across many fields. Most included studies on patient safety culture were conducted in teaching hospitals or university hospitals. The study population in the cross-sectional studies was much more than that in the before-after studies. The time span between baseline and follow-up phase of before-after studies were almost over three months. Although patient safety culture is considered important in health care and patient safety, the number of studies in which patient safety culture has been estimated using the instruments in operating rooms, is fairly small. © 2017 Chinese Cochrane Center, West China Hospital of Sichuan University and John Wiley & Sons Australia, Ltd.

Image processing for safety assessment in civil engineering.

PubMed

Ferrer, Belen; Pomares, Juan C; Irles, Ramon; Espinosa, Julian; Mas, David

2013-06-20

Behavior analysis of construction safety systems is of fundamental importance to avoid accidental injuries. Traditionally, measurements of dynamic actions in civil engineering have been done through accelerometers, but high-speed cameras and image processing techniques can play an important role in this area. Here, we propose using morphological image filtering and Hough transform on high-speed video sequence as tools for dynamic measurements on that field. The presented method is applied to obtain the trajectory and acceleration of a cylindrical ballast falling from a building and trapped by a thread net. Results show that safety recommendations given in construction codes can be potentially dangerous for workers.

Consumer food handling in the home: a review of food safety studies.

PubMed

Redmond, Elizabeth C; Griffith, Christopher J

2003-01-01

Epidemiological data from Europe, North America, Australia, and New Zealand indicate that a substantial proportion of foodborne disease is attributable to improper food preparation practices in consumers' homes. International concern about consumer food safety has prompted considerable research to evaluate domestic food-handling practices. The majority of consumer food safety studies in the last decade have been conducted in the United Kingdom and Northern Ireland (48%) and in the United States (42%). Surveys (questionnaires and interviews), the most frequent means of data collection, were used in 75% of the reviewed studies. Focus groups and observational studies have also been used. One consumer food safety study examined the relationship between pathogenic microbial contamination from raw chicken and observed food-handling behaviors, and the results of this study indicated extensive Campylobacter cross-contamination during food preparation sessions. Limited information about consumers' attitudes and intentions with regard to safe food-handling behaviors has been obtained, although a substantial amount of information about consumer knowledge and self-reported practices is available. Observation studies suggest that substantial numbers of consumers frequently implement unsafe food-handling practices. Knowledge, attitudes, intentions, and self-reported practices did not correspond to observed behaviors, suggesting that observational studies provide a more realistic indication of the food hygiene actions actually used in domestic food preparation. An improvement in consumer food-handling behavior is likely to reduce the risk and incidence of foodborne disease. The need for the development and implementation of food safety education strategies to improve specific food safety behaviors is reviewed in this paper.

Inside the Black Box: The Case Review Process of an Elder Abuse Forensic Center.

PubMed

Navarro, Adria E; Wysong, Julia; DeLiema, Marguerite; Schwartz, Elizabeth L; Nichol, Michael B; Wilber, Kathleen H

2016-08-01

Preliminary evidence suggests that elder abuse forensic centers improve victim welfare by increasing necessary prosecutions and conservatorships and reducing the recurrence of protective service referrals. Center team members gather information and make decisions designed to protect clients and their assets, yet the collective process of how these case reviews are conducted remains unexamined. The purpose of this study is to present a model describing the interprofessional approach of investigation and response to financial exploitation (FE), a frequent and complex type of abuse of vulnerable adults. To develop an understanding of the case review process at the Los Angeles County Elder Abuse Forensic Center (Center), a quasi-Delphi field study approach was used involving direct observations of meetings, surveying team members, and review from the Center's Advisory Council. The goal of this iterative analysis was to understand the case review process for suspected FE in Los Angeles County. A process map of key forensic center elements was developed that may be useful for replication in other settings. The process map includes: (a) multidisciplinary data collection, (b) key decisions for consideration, and (c) strategic actions utilized by an interprofessional team focused on elder justice. Elder justice relies on a complex system of providers. Elder abuse forensic centers provide a process designed to efficiently address client safety, client welfare, and protection of assets. Study findings provide a process map that may help other communities replicate an established multidisciplinary team, one experienced with justice system outcomes designed to protect FE victims. © The Author 2015. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Microbial bioinformatics for food safety and production

PubMed Central

Alkema, Wynand; Boekhorst, Jos; Wels, Michiel

2016-01-01

In the production of fermented foods, microbes play an important role. Optimization of fermentation processes or starter culture production traditionally was a trial-and-error approach inspired by expert knowledge of the fermentation process. Current developments in high-throughput ‘omics’ technologies allow developing more rational approaches to improve fermentation processes both from the food functionality as well as from the food safety perspective. Here, the authors thematically review typical bioinformatics techniques and approaches to improve various aspects of the microbial production of fermented food products and food safety. PMID:26082168

Emotion regulation during threat: Parsing the time course and consequences of safety signal processing

PubMed Central

HEFNER, KATHRYN R.; VERONA, EDELYN; CURTIN, JOHN. J.

2017-01-01

Improved understanding of fear inhibition processes can inform the etiology and treatment of anxiety disorders. Safety signals can reduce fear to threat, but precise mechanisms remain unclear. Safety signals may acquire attentional salience and affective properties (e.g., relief) independent of the threat; alternatively, safety signals may only hold affective value in the presence of simultaneous threat. To clarify such mechanisms, an experimental paradigm assessed independent processing of threat and safety cues. Participants viewed a series of red and green words from two semantic categories. Shocks were administered following red words (cue+). No shocks followed green words (cue−). Words from one category were defined as safety signals (SS); no shocks were administered on cue+ trials. Words from the other (control) category did not provide information regarding shock administration. Threat (cue+ vs. cue−) and safety (SS+ vs. SS−) were fully crossed. Startle response and ERPs were recorded. Startle response was increased during cue+ versus cue−. Safety signals reduced startle response during cue+, but had no effect on startle response during cue−. ERP analyses (PD130 and P3) suggested that participants parsed threat and safety signal information in parallel. Motivated attention was not associated with safety signals in the absence of threat. Overall, these results confirm that fear can be reduced by safety signals. Furthermore, safety signals do not appear to hold inherent hedonic salience independent of their effect during threat. Instead, safety signals appear to enable participants to engage in effective top-down emotion regulatory processes. PMID:27088643

Safety and efficacy of physical restraints for the elderly. Review of the evidence.

PubMed Central

Frank, C.; Hodgetts, G.; Puxty, J.

1996-01-01

OBJECTIVE: To critically review evidence on the safety and efficacy of physical restraints for the elderly and to provide family physicians with guidelines for rational use of restraints. DATA SOURCES: Articles cited on MEDLINE (from 1989 to November 1994) and Cinahl (from 1982 to 1994) under the MeSH heading "physical restraints." STUDY SELECTION: Articles that specifically dealt with the safety and efficacy of restraints and current patterns of use, including prevalence, risk factors, and indications, were selected. Eight original research articles were identified and critically appraised. DATA EXTRACTION: Data extracted concerned the negative sequelae of restraints and the association between restraint use and fall and injury rates. General data about current patterns of restraint use were related to safety and efficacy findings. DATA SYNTHESIS: No randomized, controlled trials of physical restraint use were found in the literature. A variety of study design, including retrospective chart review, prospective cohort studies, and case reports, found little evidence that restraints prevent injury. Some evidence suggested that restraints might increase risk of falls and injury. Restraint-reduction programs have not been shown to increase fall or injury rates. Numerous case reports document injuries or deaths resulting from restraint use or misuse. CONCLUSIONS: Although current evidence does not support the belief that restraints prevent falls and injuries and questions their safety, further prospective and controlled studies are needed to clarify these issues. Information from review and research articles was synthesized in this paper to produce guidelines for the safe and rational use of restraints. PMID:8969858

Effects of genetic, processing, or product formulation changes on efficacy and safety of probiotics.

PubMed

Sanders, Mary Ellen; Klaenhammer, Todd R; Ouwehand, Arthur C; Pot, Bruno; Johansen, Eric; Heimbach, James T; Marco, Maria L; Tennilä, Julia; Ross, R Paul; Franz, Charles; Pagé, Nicolas; Pridmore, R David; Leyer, Greg; Salminen, Seppo; Charbonneau, Duane; Call, Emma; Lenoir-Wijnkoop, Irene

2014-02-01

Commercial probiotic strains for food or supplement use can be altered in different ways for a variety of purposes. Production conditions for the strain or final product may be changed to address probiotic yield, functionality, or stability. Final food products may be modified to improve flavor and other sensory properties, provide new product formats, or respond to market opportunities. Such changes can alter the expression of physiological traits owing to the live nature of probiotics. In addition, genetic approaches may be used to improve strain attributes. This review explores whether genetic or phenotypic changes, by accident or design, might affect the efficacy or safety of commercial probiotics. We highlight key issues important to determining the need to re-confirm efficacy or safety after strain improvement, process optimization, or product formulation changes. Research pinpointing the mechanisms of action for probiotic function and the development of assays to measure them are greatly needed to better understand if such changes have a substantive impact on probiotic efficacy. © 2014 New York Academy of Sciences.

How important is vehicle safety for older consumers in the vehicle purchase process?

PubMed

Koppel, Sjaan; Clark, Belinda; Hoareau, Effie; Charlton, Judith L; Newstead, Stuart V

2013-01-01

This study aimed to investigate the importance of vehicle safety to older consumers in the vehicle purchase process. Older (n = 102), middle-aged (n = 791), and younger (n = 109) participants throughout the eastern Australian states of Victoria, New South Wales, and Queensland who had recently purchased a new or used vehicle completed an online questionnaire about their vehicle purchase process. When asked to list the 3 most important considerations in the vehicle purchase process (in an open-ended format), older consumers were mostly likely to list price as their most important consideration (43%). Similarly, when presented with a list of vehicle factors (such as price, design, Australasian New Car Assessment Program [ANCAP] rating), older consumers were most likely to identify price as the most important vehicle factor (36%). When presented with a list of vehicle features (such as automatic transmission, braking, air bags), older consumers in the current study were most likely to identify an antilock braking system (41%) as the most important vehicle feature, and 50 percent of older consumers identified a safety-related vehicle feature as the highest priority vehicle feature (50%). When asked to list up to 3 factors that make a vehicle safe, older consumers in the current study were most likely to list braking systems (35%), air bags (22%), and the driver's behavior or skill (11%). When asked about the influence of safety in the new vehicle purchase process, one third of older consumers reported that all new vehicles are safe (33%) and almost half of the older consumers rated their vehicle as safer than average (49%). A logistic regression model was developed to predict the profile of older consumers more likely to assign a higher priority to safety features in the vehicle purchasing process. The model predicted that the importance of safety-related features was influenced by several variables, including older consumers' beliefs that they could protect themselves

Centralized or decentralized perinatal surgical care for rural women: a realist review of the evidence on safety.

PubMed

Kornelsen, Jude; McCartney, Kevin; Williams, Kim

2016-08-13

The precipitous closure of rural maternity services in British Columbia (BC), Canada, and internationally has demanded a reevaluation of how to meet the perinatal surgical needs of rural women in accordance with the Triple Aim objectives of safety, cost-effectiveness, and satisfaction of all key stakeholders. There is emerging international evidence that General Practitioners with Enhanced Surgical Skills (GPESS) are a well-positioned health service solution due to their generalist nature in low-volume settings. A realist review was undertaken to evaluate international evidence on efficacious models of perinatal surgical care. This article presents findings of the safety of such practice, one discrete part of the full realist review. This paper was derived from a larger review, which used a realist review methodology to guide the approach, and adhered to the RAMESES quality standard for realist reviews. Seven academic databases were searched in December 2013, using year (1990) and language (English) limiters in keeping with a rapid review approach. Mining of bibliographies in addition to consultation with international experts led to further inclusion of academic and grey literature up to March 2014. Two hundred fifty-four articles were originally identified; 119 articles were removed from consideration for lack of fit, resulting in the review of 191 articles from the peer reviewed and grey literature. Of these, 53 pertained to safety and are considered herein. Evidence on the safety of GPESS was consistent in the literature cited. Clinical, case study, and qualitative evidence demonstrates that perinatal surgical care is equally safe when provided by GPESS and specialist physicians. Findings allow health planners to confidently build perinatal surgical services around the contribution of GPs with enhanced surgical skills and focus on educational, regulatory, and continuing professional development mechanisms to ensure their sustainability. Volume

The outcomes of recent patient safety education interventions for trainee physicians and medical students: a systematic review

PubMed Central

Kirkman, Matthew A; Sevdalis, Nick; Arora, Sonal; Baker, Paul; Vincent, Charles; Ahmed, Maria

2015-01-01

Objective To systematically review the latest evidence for patient safety education for physicians in training and medical students, updating, extending and improving on a previous systematic review on this topic. Design A systematic review. Data sources Embase, Ovid Medline and PsycINFO databases. Study selection Studies including an evaluation of patient safety training interventions delivered to trainees/residents and medical students published between January 2009 and May 2014. Data extraction The review was performed using a structured data capture tool. Thematic analysis also identified factors influencing successful implementation of interventions. Results We identified 26 studies reporting patient safety interventions: 11 involving students and 15 involving trainees/residents. Common educational content included a general overview of patient safety, root cause/systems-based analysis, communication and teamwork skills, and quality improvement principles and methodologies. The majority of courses were well received by learners, and improved patient safety knowledge, skills and attitudes. Moreover, some interventions were shown to result in positive behaviours, notably subsequent engagement in quality improvement projects. No studies demonstrated patient benefit. Availability of expert faculty, competing curricular/service demands and institutional culture were important factors affecting implementation. Conclusions There is an increasing trend for developing educational interventions in patient safety delivered to trainees/residents and medical students. However, significant methodological shortcomings remain and additional evidence of impact on patient outcomes is needed. While there is some evidence of enhanced efforts to promote sustainability of such interventions, further work is needed to encourage their wider adoption and spread. PMID:25995240

A Process-Centered Tool for Evaluating Patient Safety Performance and Guiding Strategic Improvement

DTIC Science & Technology

2005-01-01

next patient safety steps in individual health care organizations. The low priority given to Category 3 (Focus on patients , other customers , and...presents a patient safety applicator tool for implementing and assessing patient safety systems in health care institutions. The applicator tool consists...the survey rounds. The study addressed three research questions: 1. What critical processes should be included in health care patient safety systems

The Role of Fear Appeals in Improving Driver Safety: A Review of the Effectiveness of Fear-Arousing (Threat) Appeals in Road Safety Advertising

ERIC Educational Resources Information Center

Lewis, I.; Watson, B.; Tay, R.; White, K. M.

2007-01-01

This paper reviews theoretical and empirical evidence relating to the effectiveness of fear (threat) appeals in improving driver safety. The results of the review highlight the mixed and inconsistent findings that have been reported in the literature. While fear arousal appears important for attracting attention, its contribution to behaviour…

Reduction of Thoroughbred racing fatalities at New York Racing Association racetracks using a multi-disciplinary mortality review process.

PubMed

Palmer, Scott E; McDonough, Sean P; Mohammed, Hussni O

2017-07-01

Between January 1, 2013 and December 31, 2015, findings of a New York State Gaming Commission-Cornell University postmortem examination program were utilized in a multi-disciplinary mortality review process to review 129 racing fatalities at Thoroughbred racetracks operated by the New York Racing Association (NYRA). Musculoskeletal fractures comprised 79% of the fatalities; cardiopulmonary conditions accounted for 12% of the fatalities. Other causes of death included gastrointestinal (3%), respiratory (5%), and central nervous system (2%) conditions. Fetlock failure represented 50% of the musculoskeletal fatalities. The general distribution of these findings was very similar to that reported by the California Animal Health and Food Safety Laboratory System during the same period. These findings, used in conjunction with a comprehensive mortality review process and regulatory reform, have contributed to a significant reduction of the incidence of Thoroughbred racing fatalities at NYRA racetracks during the period of this review.

Annual Safety Education Review 1970.

ERIC Educational Resources Information Center

American Association for Health, Physical Education, and Recreation, Washington, DC.

This booklet presents articles completed in 1970 by the Division of Safety Education of the American Association for Health, Physical Education, and Recreation. The 11 articles deal with the following topics: a) the problem of apathy in safety education, b) the safety aspects of archery and riflery, c) weight training for high school girls, d)…

75 FR 80538 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-22

...The Department of Labor (DOL) hereby announces the submission of the Mine Safety and Health Administration (MSHA)sponsored information collection request (ICR) titled, ``Safety Defects; Examination, Correction, and Records,'' to the Office of Management and Budget (OMB) for review and approval for continued use in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35).

77 FR 43811 - Submission for OMB Review; Comment Request-Safety Standards for Full-Size Baby Cribs and Non-Full...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-26

... CONSUMER PRODUCT SAFETY COMMISSION Submission for OMB Review; Comment Request--Safety Standards for Full-Size Baby Cribs and Non-Full-Size Baby Cribs; Compliance Form AGENCY: Consumer Product Safety Commission. ACTION: Notice. SUMMARY: The Consumer Product Safety Commission (CPSC or Commission) announces...

US policies to enhance older driver safety: a systematic review of the literature.

PubMed

Dugan, Elizabeth; Barton, Kelli N; Coyle, Caitlin; Lee, Chae Man

2013-01-01

The purpose of this study was to conduct a systematic review of the literature related to state policies concerning older drivers and to draw policy conclusions about which policies appear to work to reduce older driver crashes and to identify areas needed for further research. Specific policies examined in this paper concern medical reporting and medical review, license renewal processes, and driver testing. A study was included in the systematic review if it met the following criteria: published in English between 1991and January 2013; included data on human subjects aged 65 and older residing in the United States; included information on at least one policy related to older drivers; and had a transportation-related outcome variable (e.g., crash, fatality, renewal). A total of 29 studies met inclusion criteria. Twenty-two studies investigated license renewal and seven articles examined medical reporting. In-person license renewal requirements were associated with reduced risk for fatal crashes. Restricted licenses were associated with reduced number of miles driven per week. More intensive renewal requirements and being the subject of a medical report to the licensing authority was associated with delicensure. Given the importance of driving to mobility, quality of life, and public safety, more research is needed.

Employer, use of personal protective equipment, and work safety climate: Latino poultry processing workers.

PubMed

Arcury, Thomas A; Grzywacz, Joseph G; Anderson, Andrea M; Mora, Dana C; Carrillo, Lourdes; Chen, Haiying; Quandt, Sara A

2013-02-01

This analysis describes the work safety climate of Latino poultry processing workers and notes differences by worker personal characteristics and employer; describes the use of common personal protective equipment (PPE) among workers; and examines the associations of work safety climate with use of common PPE. Data are from a cross-sectional study of 403 Latino poultry processing workers in western North Carolina. Work safety climate differed little by personal characteristics, but it did differ consistently by employer. Provision of PPE varied; for example, 27.2% of participants were provide with eye protection at no cost, 57.0% were provided with hand protection at no cost, and 84.7% were provided with protective clothing at no cost. PPE use varied by type. Provision of PPE at no cost was associated with lower work safety climate; this result was counter-intuitive. Consistent use of PPE was associated with higher work safety climate. Work safety climate is important for improving workplace safety for immigrant workers. Research among immigrant workers should document work safety climate for different employers and industries, and delineate how work safety climate affects safety behavior and injuries. Copyright © 2012 Wiley Periodicals, Inc.

The NASA Commercial Crew Program (CCP) Mission Assurance Process

NASA Technical Reports Server (NTRS)

Canfield, Amy

2016-01-01

In 2010, NASA established the Commercial Crew Program in order to provide human access to the International Space Station and low earth orbit via the commercial (non-governmental) sector. A particular challenge to NASA has been how to determine the commercial providers transportation system complies with Programmatic safety requirements. The process used in this determination is the Safety Technical Review Board which reviews and approves provider submitted Hazard Reports. One significant product of the review is a set of hazard control verifications. In past NASA programs, 100 percent of these safety critical verifications were typically confirmed by NASA. The traditional Safety and Mission Assurance (SMA) model does not support the nature of the Commercial Crew Program. To that end, NASA SMA is implementing a Risk Based Assurance (RBA) process to determine which hazard control verifications require NASA authentication. Additionally, a Shared Assurance Model is also being developed to efficiently use the available resources to execute the verifications. This paper will describe the evolution of the CCP Mission Assurance process from the beginning of the Program to its current incarnation. Topics to be covered include a short history of the CCP; the development of the Programmatic mission assurance requirements; the current safety review process; a description of the RBA process and its products and ending with a description of the Shared Assurance Model.

Medical journal peer review: process and bias.

PubMed

Manchikanti, Laxmaiah; Kaye, Alan D; Boswell, Mark V; Hirsch, Joshua A

2015-01-01

Scientific peer review is pivotal in health care research in that it facilitates the evaluation of findings for competence, significance, and originality by qualified experts. While the origins of peer review can be traced to the societies of the eighteenth century, it became an institutionalized part of the scholarly process in the latter half of the twentieth century. This was a response to the growth of research and greater subject specialization. With the current increase in the number of specialty journals, the peer review process continues to evolve to meet the needs of patients, clinicians, and policy makers. The peer review process itself faces challenges. Unblinded peer review might suffer from positive or negative bias towards certain authors, specialties, and institutions. Peer review can also suffer when editors and/or reviewers might be unable to understand the contents of the submitted manuscript. This can result in an inability to detect major flaws, or revelations of major flaws after acceptance of publication by the editors. Other concerns include potentially long delays in publication and challenges uncovering plagiarism, duplication, corruption and scientific misconduct. Conversely, a multitude of these challenges have led to claims of scientific misconduct and an erosion of faith. These challenges have invited criticism of the peer review process itself. However, despite its imperfections, the peer review process enjoys widespread support in the scientific community. Peer review bias is one of the major focuses of today's scientific assessment of the literature. Various types of peer review bias include content-based bias, confirmation bias, bias due to conservatism, bias against interdisciplinary research, publication bias, and the bias of conflicts of interest. Consequently, peer review would benefit from various changes and improvements with appropriate training of reviewers to provide quality reviews to maintain the quality and integrity of

A Case Study of Measuring Process Risk for Early Insights into Software Safety

NASA Technical Reports Server (NTRS)

Layman, Lucas; Basili, Victor; Zelkowitz, Marvin V.; Fisher, Karen L.

2011-01-01

In this case study, we examine software safety risk in three flight hardware systems in NASA's Constellation spaceflight program. We applied our Technical and Process Risk Measurement (TPRM) methodology to the Constellation hazard analysis process to quantify the technical and process risks involving software safety in the early design phase of these projects. We analyzed 154 hazard reports and collected metrics to measure the prevalence of software in hazards and the specificity of descriptions of software causes of hazardous conditions. We found that 49-70% of 154 hazardous conditions could be caused by software or software was involved in the prevention of the hazardous condition. We also found that 12-17% of the 2013 hazard causes involved software, and that 23-29% of all causes had a software control. The application of the TPRM methodology identified process risks in the application of the hazard analysis process itself that may lead to software safety risk.

Fact sheet for Applicants Intergovernmental Review Process

EPA Pesticide Factsheets

When submitting your application for Federal assistance, please observe the following steps pertaining to the intergovernmental review process. This is the Fact sheet for Applicants Intergovernmental Review Process.

Hospital Nurses' Work Environment Characteristics and Patient Safety Outcomes: A Literature Review.

PubMed

Lee, Seung Eun; Scott, Linda D

2018-01-01

This integrative literature review assesses the relationship between hospital nurses' work environment characteristics and patient safety outcomes and recommends directions for future research based on examination of the literature. Using an electronic search of five databases, 18 studies published in English between 1999 and 2016 were identified for review. All but one study used a cross-sectional design, and only four used a conceptual/theoretical framework to guide the research. No definition of work environment was provided in most studies. Differing variables and instruments were used to measure patient outcomes, and findings regarding the effects of work environment on patient outcomes were inconsistent. To clarify the relationship between nurses' work environment characteristics and patient safety outcomes, researchers should consider using a longitudinal study design, using a theoretical foundation, and providing clear operational definitions of concepts. Moreover, given the inconsistent findings of previous studies, they should choose their measurement methodologies with care.

Enhancing Safety of Artificially Ventilated Patients Using Ambient Process Analysis.

PubMed

Lins, Christian; Gerka, Alexander; Lüpkes, Christian; Röhrig, Rainer; Hein, Andreas

2018-01-01

In this paper, we present an approach for enhancing the safety of artificially ventilated patients using ambient process analysis. We propose to use an analysis system consisting of low-cost ambient sensors such as power sensor, RGB-D sensor, passage detector, and matrix infrared temperature sensor to reduce risks for artificially ventilated patients in both home and clinical environments. We describe the system concept and our implementation and show how the system can contribute to patient safety.

FMCSA safety program effectiveness measurement : compliance review effectiveness model results for carriers with compliance reviews in fiscal year 2009.

DOT National Transportation Integrated Search

2014-04-01

In FY 2009, Federal and State enforcement personnel conducted more than 15,000 compliance reviews (CRs) on individual motor carriers. It is intended that through education, heightened safety regulation awareness, and the enforcement effects of the CR...

Integrating Safety and Mission Assurance in Design

NASA Technical Reports Server (NTRS)

Cianciola, Chris; Crane, Kenneth

2008-01-01

This presentation describes how the Ares Projects are learning from the successes and failures of previous launch systems in order to maximize safety and reliability while maintaining fiscal responsibility. The Ares Projects are integrating Safety and Mission Assurance into design activities and embracing independent assessments by Quality experts in thorough reviews of designs and processes. Incorporating Lean thinking into the design process, Ares is also streamlining existing processes and future manufacturing flows which will yield savings during production. Understanding the value of early involvement of Quality experts, the Ares Projects are leading launch vehicle development into the 21st century.

Heat transfer phenomena during thermal processing of liquid particulate mixtures-A review.

PubMed

Singh, Anubhav Pratap; Singh, Anika; Ramaswamy, Hosahalli S

2017-05-03

During the past few decades, food industry has explored various novel thermal and non-thermal processing technologies to minimize the associated high-quality loss involved in conventional thermal processing. Among these are the novel agitation systems that permit forced convention in canned particulate fluids to improve heat transfer, reduce process time, and minimize heat damage to processed products. These include traditional rotary agitation systems involving end-over-end, axial, or biaxial rotation of cans and the more recent reciprocating (lateral) agitation. The invention of thermal processing systems with induced container agitation has made heat transfer studies more difficult due to problems in tracking the particle temperatures due to their dynamic motion during processing and complexities resulting from the effects of forced convection currents within the container. This has prompted active research on modeling and characterization of heat transfer phenomena in such systems. This review brings to perspective, the current status on thermal processing of particulate foods, within the constraints of lethality requirements from safety view point, and discusses available techniques of data collection, heat transfer coefficient evaluation, and the critical processing parameters that affect these heat transfer coefficients, especially under agitation processing conditions.

A Review of Safety and Design Requirements of the Artificial Pancreas.

PubMed

Blauw, Helga; Keith-Hynes, Patrick; Koops, Robin; DeVries, J Hans

2016-11-01

As clinical studies with artificial pancreas systems for automated blood glucose control in patients with type 1 diabetes move to unsupervised real-life settings, product development will be a focus of companies over the coming years. Directions or requirements regarding safety in the design of an artificial pancreas are, however, lacking. This review aims to provide an overview and discussion of safety and design requirements of the artificial pancreas. We performed a structured literature search based on three search components-type 1 diabetes, artificial pancreas, and safety or design-and extended the discussion with our own experiences in developing artificial pancreas systems. The main hazards of the artificial pancreas are over- and under-dosing of insulin and, in case of a bi-hormonal system, of glucagon or other hormones. For each component of an artificial pancreas and for the complete system we identified safety issues related to these hazards and proposed control measures. Prerequisites that enable the control algorithms to provide safe closed-loop control are accurate and reliable input of glucose values, assured hormone delivery and an efficient user interface. In addition, the system configuration has important implications for safety, as close cooperation and data exchange between the different components is essential.

Health Information Technology in Healthcare Quality and Patient Safety: Literature Review.

PubMed

Feldman, Sue S; Buchalter, Scott; Hayes, Leslie W

2018-06-04

The area of healthcare quality and patient safety is starting to use health information technology to prevent reportable events, identify them before they become issues, and act on events that are thought to be unavoidable. As healthcare organizations begin to explore the use of health information technology in this realm, it is often unclear where fiscal and human efforts should be focused. The purpose of this study was to provide a foundation for understanding where to focus health information technology fiscal and human resources as well as expectations for the use of health information technology in healthcare quality and patient safety. A literature review was conducted to identify peer-reviewed publications reporting on the actual use of health information technology in healthcare quality and patient safety. Inductive thematic analysis with open coding was used to categorize a total of 41 studies. Three pre-set categories were used: prevention, identification, and action. Three additional categories were formed through coding: challenges, outcomes, and location. This study identifies five main categories across seven study settings. A majority of the studies used health IT for identification and prevention of healthcare quality and patient safety issues. In this realm, alerts, clinical decision support, and customized health IT solutions were most often implemented. Implementation, interface design, and culture were most often noted as challenges. This study provides valuable information as organizations determine where they stand to get the most "bang for their buck" relative to health IT for quality and patient safety. Knowing what implementations are being effectivity used by other organizations helps with fiscal and human resource planning as well as managing expectations relative to cost, scope, and outcomes. The findings from this scan of the literature suggest that having organizational champion leaders that can shepherd implementation, impact culture

Applicability and feasibility of systematic review for performing evidence-based risk assessment in food and feed safety.

PubMed

Aiassa, E; Higgins, J P T; Frampton, G K; Greiner, M; Afonso, A; Amzal, B; Deeks, J; Dorne, J-L; Glanville, J; Lövei, G L; Nienstedt, K; O'connor, A M; Pullin, A S; Rajić, A; Verloo, D

2015-01-01

Food and feed safety risk assessment uses multi-parameter models to evaluate the likelihood of adverse events associated with exposure to hazards in human health, plant health, animal health, animal welfare, and the environment. Systematic review and meta-analysis are established methods for answering questions in health care, and can be implemented to minimize biases in food and feed safety risk assessment. However, no methodological frameworks exist for refining risk assessment multi-parameter models into questions suitable for systematic review, and use of meta-analysis to estimate all parameters required by a risk model may not be always feasible. This paper describes novel approaches for determining question suitability and for prioritizing questions for systematic review in this area. Risk assessment questions that aim to estimate a parameter are likely to be suitable for systematic review. Such questions can be structured by their "key elements" [e.g., for intervention questions, the population(s), intervention(s), comparator(s), and outcome(s)]. Prioritization of questions to be addressed by systematic review relies on the likely impact and related uncertainty of individual parameters in the risk model. This approach to planning and prioritizing systematic review seems to have useful implications for producing evidence-based food and feed safety risk assessment.

14 CFR 414.19 - Technical criteria for reviewing a safety approval application.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Technical criteria for reviewing a safety approval application. 414.19 Section 414.19 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL... regulations. (2) Government-developed or adopted standards. (3) Industry consensus performance-based criteria...

A review of technology and safety aspects of erbium lasers in dentistry.

PubMed

Clarkson, D M

2001-01-01

This article reviews aspects of the probable mechanisms used by erbium dental lasers for cutting dentine and enamel, describes key issues of the risk of temperature elevation and speed of cutting relative to conventional techniques and looks at issues concerned with the safety of lasers.

Cannabis for therapeutic purposes and public health and safety: a systematic and critical review.

PubMed

Sznitman, Sharon R; Zolotov, Yuval

2015-01-01

The use of Cannabis for Therapeutic Purposes (CTP) has recently become legal in many places. These policy and legal modifications may be related to changes in cannabis perceptions, availability and use and in the way cannabis is grown and sold. This may in turn have effects on public health and safety. To better understand the potential effects of CTP legalization on public health and safety, the current paper synthesizes and critically discusses the relevant literature. Twenty-eight studies were identified by a comprehensive search strategy, and their characteristics and main findings were systematically reviewed according to the following content themes: CTP and illegal cannabis use; CTP and other public health issues; CTP, crime and neighbourhood disadvantage. The research field is currently limited by a lack of theoretical and methodological rigorous studies. The review shows that the most prevalent theme of investigation so far has been the relation between CTP and illegal cannabis use. In addition, the literature review shows that there is an absence of evidence to support many common concerns related to detrimental public health and safety effects of CTP legalization. Although lack of evidence provides some reassurance that CTP legalization may not have posed a substantial threat to public health and safety, this conclusion needs to be examined in light of the limitations of studies conducted so far. Furthermore, as CTP policy continues to evolve, including incorporation of greater commercialization, it is possible that the full effects of CTP legalization have yet to take place. Ensuring study quality will allow future research to better investigate the complex role that CTP plays in relation to society at large, and public health and safety in particular. Copyright © 2014 Elsevier B.V. All rights reserved.

An Evaluation of the Decennial Review Process.

ERIC Educational Resources Information Center

Barak, Robert; And Others

Information on a review of the decennial review process required by the Arizona Board of Regents (ABOR) for every academic department in each Arizona university is presented as part of the final report by ABOR's Task Force on Excellence, Efficiency and Competitiveness. Revision in the review process and eight policy statements are discussed, and…

Participatory design of a preliminary safety checklist for general practice

PubMed Central

Bowie, Paul; Ferguson, Julie; MacLeod, Marion; Kennedy, Susan; de Wet, Carl; McNab, Duncan; Kelly, Moya; McKay, John; Atkinson, Sarah

2015-01-01

Background The use of checklists to minimise errors is well established in high reliability, safety-critical industries. In health care there is growing interest in checklists to standardise checking processes and ensure task completion, and so provide further systemic defences against error and patient harm. However, in UK general practice there is limited experience of safety checklist use. Aim To identify workplace hazards that impact on safety, health and wellbeing, and performance, and codesign a standardised checklist process. Design and setting Application of mixed methods to identify system hazards in Scottish general practices and develop a safety checklist based on human factors design principles. Method A multiprofessional ‘expert’ group (n = 7) and experienced front-line GPs, nurses, and practice managers (n = 18) identified system hazards and developed and validated a preliminary checklist using a combination of literature review, documentation review, consensus building workshops using a mini-Delphi process, and completion of content validity index exercise. Results A prototype safety checklist was developed and validated consisting of six safety domains (for example, medicines management), 22 sub-categories (for example, emergency drug supplies) and 78 related items (for example, stock balancing, secure drug storage, and cold chain temperature recording). Conclusion Hazards in the general practice work system were prioritised that can potentially impact on the safety, health and wellbeing of patients, GP team members, and practice performance, and a necessary safety checklist prototype was designed. However, checklist efficacy in improving safety processes and outcomes is dependent on user commitment, and support from leaders and promotional champions. Although further usability development and testing is necessary, the concept should be of interest in the UK and internationally. PMID:25918338

Safety management of complex research operations

NASA Technical Reports Server (NTRS)

Brown, W. J.

1981-01-01

Complex research and technology operations present many varied potential hazards which must be addressed in a disciplined independent safety review and approval process. The research and technology effort at the Lewis Research Center is divided into programmatic areas of aeronautics, space and energy. Potential hazards vary from high energy fuels to hydrocarbon fuels, high pressure systems to high voltage systems, toxic chemicals to radioactive materials and high speed rotating machinery to high powered lasers. A Safety Permit System presently covers about 600 potentially hazardous operations. The Safety Management Program described in this paper is believed to be a major factor in maintaining an excellent safety record at the Lewis Research Center.

Safety of foods treated with novel process intervention technologies

USDA-ARS?s Scientific Manuscript database

Many consumers are familiar with traditional food safety and preservation technologies such as thermal processing (cooking), salting, and pickling to inactivate common foodborne pathogens such as Salmonella spp. and Escherichia coli O157:H7. Many consumers are less familiar with other technologies s...

Diffusion of robotics into clinical practice in the United States: process, patient safety, learning curves, and the public health.

PubMed

Mirheydar, Hossein S; Parsons, J Kellogg

2013-06-01

Robotic technology disseminated into urological practice without robust comparative effectiveness data. To review the diffusion of robotic surgery into urological practice. We performed a comprehensive literature review focusing on diffusion patterns, patient safety, learning curves, and comparative costs for robotic radical prostatectomy, partial nephrectomy, and radical cystectomy. Robotic urologic surgery diffused in patterns typical of novel technology spreading among practicing surgeons. Robust evidence-based data comparing outcomes of robotic to open surgery were sparse. Although initial Level 3 evidence for robotic prostatectomy observed complication outcomes similar to open prostatectomy, subsequent population-based Level 2 evidence noted an increased prevalence of adverse patient safety events and genitourinary complications among robotic patients during the early years of diffusion. Level 2 evidence indicated comparable to improved patient safety outcomes for robotic compared to open partial nephrectomy and cystectomy. Learning curve recommendations for robotic urologic surgery have drawn exclusively on Level 4 evidence and subjective, non-validated metrics. The minimum number of cases required to achieve competency for robotic prostatectomy has increased to unrealistically high levels. Most comparative cost-analyses have demonstrated that robotic surgery is significantly more expensive than open or laparoscopic surgery. Evidence-based data are limited but suggest an increased prevalence of adverse patient safety events for robotic prostatectomy early in the national diffusion period. Learning curves for robotic urologic surgery are subjective and based on non-validated metrics. The urological community should develop rigorous, evidence-based processes by which future technological innovations may diffuse in an organized and safe manner.

A review for identification of initiating events in event tree development process on nuclear power plants

NASA Astrophysics Data System (ADS)

Riyadi, Eko H.

2014-09-01

Initiating event is defined as any event either internal or external to the nuclear power plants (NPPs) that perturbs the steady state operation of the plant, if operating, thereby initiating an abnormal event such as transient or loss of coolant accident (LOCA) within the NPPs. These initiating events trigger sequences of events that challenge plant control and safety systems whose failure could potentially lead to core damage or large early release. Selection for initiating events consists of two steps i.e. first step, definition of possible events, such as by evaluating a comprehensive engineering, and by constructing a top level logic model. Then the second step, grouping of identified initiating event's by the safety function to be performed or combinations of systems responses. Therefore, the purpose of this paper is to discuss initiating events identification in event tree development process and to reviews other probabilistic safety assessments (PSA). The identification of initiating events also involves the past operating experience, review of other PSA, failure mode and effect analysis (FMEA), feedback from system modeling, and master logic diagram (special type of fault tree). By using the method of study for the condition of the traditional US PSA categorization in detail, could be obtained the important initiating events that are categorized into LOCA, transients and external events.

[Process management in the hospital pharmacy for the improvement of the patient safety].

PubMed

Govindarajan, R; Perelló-Juncá, A; Parès-Marimòn, R M; Serrais-Benavente, J; Ferrandez-Martí, D; Sala-Robinat, R; Camacho-Calvente, A; Campabanal-Prats, C; Solà-Anderiu, I; Sanchez-Caparrós, S; Gonzalez-Estrada, J; Martinez-Olalla, P; Colomer-Palomo, J; Perez-Mañosas, R; Rodríguez-Gallego, D

2013-01-01

To define a process management model for a hospital pharmacy in order to measure, analyse and make continuous improvements in patient safety and healthcare quality. In order to implement process management, Igualada Hospital was divided into different processes, one of which was the Hospital Pharmacy. A multidisciplinary management team was given responsibility for each process. For each sub-process one person was identified to be responsible, and a working group was formed under his/her leadership. With the help of each working group, a risk analysis using failure modes and effects analysis (FMEA) was performed, and the corresponding improvement actions were implemented. Sub-process indicators were also identified, and different process management mechanisms were introduced. The first risk analysis with FMEA produced more than thirty preventive actions to improve patient safety. Later, the weekly analysis of errors, as well as the monthly analysis of key process indicators, permitted us to monitor process results and, as each sub-process manager participated in these meetings, also to assume accountability and responsibility, thus consolidating the culture of excellence. The introduction of different process management mechanisms, with the participation of people responsible for each sub-process, introduces a participative management tool for the continuous improvement of patient safety and healthcare quality. Copyright © 2012 SECA. Published by Elsevier Espana. All rights reserved.

NASA Aviation Safety Program Systems Analysis/Program Assessment Metrics Review

NASA Technical Reports Server (NTRS)

Louis, Garrick E.; Anderson, Katherine; Ahmad, Tisan; Bouabid, Ali; Siriwardana, Maya; Guilbaud, Patrick

2003-01-01

The goal of this project is to evaluate the metrics and processes used by NASA's Aviation Safety Program in assessing technologies that contribute to NASA's aviation safety goals. There were three objectives for reaching this goal. First, NASA's main objectives for aviation safety were documented and their consistency was checked against the main objectives of the Aviation Safety Program. Next, the metrics used for technology investment by the Program Assessment function of AvSP were evaluated. Finally, other metrics that could be used by the Program Assessment Team (PAT) were identified and evaluated. This investigation revealed that the objectives are in fact consistent across organizational levels at NASA and with the FAA. Some of the major issues discussed in this study which should be further investigated, are the removal of the Cost and Return-on-Investment metrics, the lack of the metrics to measure the balance of investment and technology, the interdependencies between some of the metric risk driver categories, and the conflict between 'fatal accident rate' and 'accident rate' in the language of the Aviation Safety goal as stated in different sources.

Patient safety and health policy: a history and review.

PubMed

Small, Stephen D; Barach, Paul

2002-12-01

Policy initiatives on many fronts have converged to improve patient safety. A major tension that characterizes this process is the attempt to achieve a balance between learning and control in complex systems with technical, social, and organizational components. Efforts to improve learning are marked by better information flow, discovery, flexibility in thinking, embracing of failures as learning opportunities, and core incentives to promote voluntary participation of all stakeholders in the process. Efforts to improve accountability are traditionally marked by public disclosure, meeting of certain widely disseminated standards, availability of performance measures, exposure to legal liability, and compliance with mandated directives (statutes, regulations, accreditation requirements). In some sense, these directions are mutually exclusive. Although a more collaborative regulatory-improvement model would be helpful in creating an industrywide safety culture, it is likely that learning and accountability functions will follow separate tracks. An exception would be policy that stimulates organizations to comply with regulation by showing how well and by what methods they are learning and how others can profit from these experiences. Any approach to improving patient safety should, at a minimum, include a nonpunitive in-depth mechanism for reporting incidents, postincident evaluations for identification of system changes to prevent subsequent occurrences, and state-guaranteed legislative protection from discovery for all aspects of information gathered to improve patient safety. Nonpunitive approaches have yielded useful results in other industries [43]. State and federal courts, state licensing boards, and accrediting bodies such as JCAHO all function to maintain accountability and standards; however, the very fear of existing legal liability or its misapplication are the greatest hurdles to pioneering patient-safety efforts. The health care system needs to transform

Demystifying the Occupational Safety and Health Administration inspection process.

PubMed

Price, Lowell L; Goodman, Terri

2006-04-01

Being prepared for an Occupational Safety and Health Administration (OSHA) inspection can save a facility money, as well as potentially protect employees from serious illness or injury. This article explains the OSHA inspection process, types of violations that may be cited and the appeals process for employers and employees. Actual citations given in four recent OSHA health care facility inspections are discussed and general recommendations to prepare for an OSHA site visit are given.

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

PubMed

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

2018-03-14

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

Safety focused modeling of lithium-ion batteries: A review

NASA Astrophysics Data System (ADS)

Abada, S.; Marlair, G.; Lecocq, A.; Petit, M.; Sauvant-Moynot, V.; Huet, F.

2016-02-01

Safety issues pertaining to Li-ion batteries justify intensive testing all along their value chain. However, progress in scientific knowledge regarding lithium based battery failure modes, as well as remarkable technologic breakthroughs in computing science, now allow for development and use of prediction tools to assist designers in developing safer batteries. Subsequently, this paper offers a review of significant modeling works performed in the area with a focus on the characterization of the thermal runaway hazard and their relating triggering events. Progress made in models aiming at integrating battery ageing effect and related physics is also discussed, as well as the strong interaction with modeling-focused use of testing, and the main achievements obtained towards marketing safer systems. Current limitations and new challenges or opportunities that are expected to shape future modeling activity are also put in perspective. According to market trends, it is anticipated that safety may still act as a restraint in the search for acceptable compromise with overall performance and cost of lithium-ion based and post lithium-ion rechargeable batteries of the future. In that context, high-throughput prediction tools capable of screening adequate new components properties allowing access to both functional and safety related aspects are highly desirable.

Efficacy and safety of biologic therapies for systemic lupus erythematosus treatment: systematic review and meta-analysis.

PubMed

Borba, Helena Hiemisch Lobo; Wiens, Astrid; de Souza, Thais Teles; Correr, Cassyano Januário; Pontarolo, Roberto

2014-04-01

The objectives of this study were to evaluate the efficacy, safety, and tolerability of biologic drugs compared with placebo for systemic lupus erythematosus (SLE) treatment. A systematic review evaluating the efficacy and safety of biologic therapies compared with placebo in adult SLE patients treatment was performed. Data from studies performed before September 2013 were collected from several databases (MEDLINE, Cochrane Library, SCIELO, Scopus, and International Pharmaceutical Abstracts). Study eligibility criteria included randomized, double-blind, placebo-controlled trials; regarding treatment with biologic agents in SLE adult patients; and published in English, German, Portuguese, and Spanish. Extracted data were statistically analyzed in a meta-analysis using the Review Manager (RevMan) 5.1 software. Efficacy outcomes included the SELENA-SLEDAI (Safety of Estrogens in Lupus Erythematosus National Assessment version of the SLE Disease Activity Index) score, the SRI (Systemic Lupus Erythematosus Responder Index), normalization of low C3 (<90 mg/dL), anti-double-stranded DNA positive to negative, and no new BILAG (British Isles Lupus Assessment Group index) 1A or 2B flares. Data on safety profile included adverse events, serious and severe adverse events, death, malignancy, infections, and infusion reactions. We also evaluated withdrawals from treatment due to lack of efficacy or adverse events. Thirteen randomized placebo-controlled trials met the criteria for data extraction for systematic review. A meta-analysis regarding the efficacy and safety of belimumab compared with placebo involving four of these trials was undertaken and the remainder contributed to a meta-analysis of the safety of biologic agents. In addition, two trials allowed the performance of a meta-analysis regarding the efficacy and safety of rituximab compared with placebo. Belimumab was more effective than placebo in most evaluated outcomes. No significant differences in the safety and

Rework and workarounds in nurse medication administration process: implications for work processes and patient safety.

PubMed

Halbesleben, Jonathon R B; Savage, Grant T; Wakefield, Douglas S; Wakefield, Bonnie J

2010-01-01

Health care organizations have redesigned existing and implemented new work processes intended to improve patient safety. As a consequence of these process changes, there are now intentionally designed "blocks" or barriers that limit how specific work actions, such as ordering and administering medication, are to be carried out. Health care professionals encountering these designed barriers can choose to either follow the new process, engage in workarounds to get past the block, or potentially repeat work (rework). Unfortunately, these workarounds and rework may lead to other safety concerns. The aim of this study was to examine rework and workarounds in hospital medication administration processes. Observations and semistructured interviews were conducted with 58 nurses from four hospital intensive care units focusing on the medication administration process. Using the constant comparative method, we analyzed the observation and interview data to develop themes regarding rework and workarounds. From this analysis, we developed an integrated process map of the medication administration process depicting blocks. A total of 12 blocks were reported by the participants. Based on the analysis, we categorized them as related to information exchange, information entry, and internal supply chain issues. Whereas information exchange and entry blocks tended to lead to rework, internal supply chain issues were more likely to lead to workarounds. A decentralized pharmacist on the unit may reduce work flow blocks (and, thus, workarounds and rework). Work process redesign may further address the problems of workarounds and rework.

Critical review of controlled release packaging to improve food safety and quality.

PubMed

Chen, Xi; Chen, Mo; Xu, Chenyi; Yam, Kit L

2018-03-19

Controlled release packaging (CRP) is an innovative technology that uses the package to release active compounds in a controlled manner to improve safety and quality for a wide range of food products during storage. This paper provides a critical review of the uniqueness, design considerations, and research gaps of CRP, with a focus on the kinetics and mechanism of active compounds releasing from the package. Literature data and practical examples are presented to illustrate how CRP controls what active compounds to release, when and how to release, how much and how fast to release, in order to improve food safety and quality.

Development of an evidence-based framework of factors contributing to patient safety incidents in hospital settings: a systematic review

PubMed Central

McEachan, Rosemary R C; Giles, Sally J; Sirriyeh, Reema; Watt, Ian S; Wright, John

2012-01-01

Objective The aim of this systematic review was to develop a ‘contributory factors framework’ from a synthesis of empirical work which summarises factors contributing to patient safety incidents in hospital settings. Design A mixed-methods systematic review of the literature was conducted. Data sources Electronic databases (Medline, PsycInfo, ISI Web of knowledge, CINAHL and EMBASE), article reference lists, patient safety websites, registered study databases and author contacts. Eligibility criteria Studies were included that reported data from primary research in secondary care aiming to identify the contributory factors to error or threats to patient safety. Results 1502 potential articles were identified. 95 papers (representing 83 studies) which met the inclusion criteria were included, and 1676 contributory factors extracted. Initial coding of contributory factors by two independent reviewers resulted in 20 domains (eg, team factors, supervision and leadership). Each contributory factor was then coded by two reviewers to one of these 20 domains. The majority of studies identified active failures (errors and violations) as factors contributing to patient safety incidents. Individual factors, communication, and equipment and supplies were the other most frequently reported factors within the existing evidence base. Conclusions This review has culminated in an empirically based framework of the factors contributing to patient safety incidents. This framework has the potential to be applied across hospital settings to improve the identification and prevention of factors that cause harm to patients. PMID:22421911

Safety and Security Interface Technology Initiative

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

Dr. Michael A. Lehto; Kevin J. Carroll; Dr. Robert Lowrie

Safety and Security Interface Technology Initiative Mr. Kevin J. Carroll Dr. Robert Lowrie, Dr. Micheal Lehto BWXT Y12 NSC Oak Ridge, TN 37831 865-576-2289/865-241-2772 carrollkj@y12.doe.gov Work Objective. Earlier this year, the Energy Facility Contractors Group (EFCOG) was asked to assist in developing options related to acceleration deployment of new security-related technologies to assist meeting design base threat (DBT) needs while also addressing the requirements of 10 CFR 830. NNSA NA-70, one of the working group participants, designated this effort the Safety and Security Interface Technology Initiative (SSIT). Relationship to Workshop Theme. “Supporting Excellence in Operations Through Safety Analysis,” (workshop theme)more » includes security and safety personnel working together to ensure effective and efficient operations. One of the specific workshop elements listed in the call for papers is “Safeguards/Security Integration with Safety.” This paper speaks directly to this theme. Description of Work. The EFCOG Safety Analysis Working Group (SAWG) and the EFCOG Security Working Group formed a core team to develop an integrated process involving both safety basis and security needs allowing achievement of the DBT objectives while ensuring safety is appropriately considered. This effort garnered significant interest, starting with a two day breakout session of 30 experts at the 2006 Safety Basis Workshop. A core team was formed, and a series of meetings were held to develop that process, including safety and security professionals, both contractor and federal personnel. A pilot exercise held at Idaho National Laboratory (INL) in mid-July 2006 was conducted as a feasibility of concept review. Work Results. The SSIT efforts resulted in a topical report transmitted from EFCOG to DOE/NNSA in August 2006. Elements of the report included: Drivers and Endstate, Control Selections Alternative Analysis Process, Terminology Crosswalk, Safety Basis

[A systematic review of the effectiveness of workplace safety interventions].

PubMed

Baldasseroni, A; Olimpi, Nadia; Bonaccorsi, G

2009-01-01

The authors carried out a systematic review of the effectiveness of workplace safety interventions, as a part of a wider project funded by CCM, Centre for Disease Control. Several electronic bibliographic databases were checked, using a standardized string selection. The string contained the following four items: the intervention; job features; type of injury; efficacy/effectiveness. Of the various databases consulted, Web of Science was the most efficient. Overall 5531 articles were selected. After reading the title and abstract, 4695 were excluded and eventually 35 systematic reviews were selected, which synthesized 769 original articles. The main topics of the selected systematic reviews were: certain sectors (building industry, agriculture, health care); personal protective equipment; work organization and prevention management at plant level; evaluation of prevention policies by national and regional authorities. A clear need for multiple bibliographical data-base search emerged at the end of this study.

General in-situation safety behaviors are uniquely associated with post-event processing.

PubMed

Mitchell, Melissa A; Schmidt, Norman B

2014-06-01

Research suggests that state anxiety and in-situation safety behaviors are associated with post-event processing (PEP) in social anxiety. Past research has obtained mixed results on whether one or both factors contribute to PEP. The current investigation evaluated state anxiety and in-situation safety behaviors (including subtypes of in-situation safety behaviors) simultaneously to determine their relative contributions to PEP. A prospective study assessed social anxiety, state anxiety, in-situation safety behaviors, PEP, and depression in the context of a speech stressor. Consistent with theory, in-situation safety behaviors were uniquely associated with greater PEP. State anxiety was not uniquely associated with PEP. Furthermore, restricting and active subtypes of in-situation safety behaviors showed specificity to PEP. Limitations of the present study include the use of a nonclinical analog sample and retrospective reporting of PEP. These findings highlight the importance of research on in-situation safety behaviors as a potential contributor to PEP. Published by Elsevier Ltd.

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,"…

Continuous-time safety-first portfolio selection with jump-diffusion processes

NASA Astrophysics Data System (ADS)

Yan, Wei

2012-04-01

This article is concerned with continuous-time portfolio selection based on a safety-first criterion under discontinuous price processes (jump-diffusion processes). The solution of the corresponding Hamilton-Jacobi-Bellman equation of the problem is demonstrated. The analytical solutions are presented when there does not exist any riskless asset. Moreover, the problem is also discussed while there exists one riskless asset.

Factors Associated With Barcode Medication Administration Technology That Contribute to Patient Safety: An Integrative Review.

PubMed

Strudwick, Gillian; Reisdorfer, Emilene; Warnock, Caroline; Kalia, Kamini; Sulkers, Heather; Clark, Carrie; Booth, Richard

In an effort to prevent medication errors, barcode medication administration technology has been implemented in many health care organizations. An integrative review was conducted to understand the effect of barcode medication administration technology on medication errors, and characteristics of use demonstrated by nurses contribute to medication safety. Addressing poor system use may support improved patient safety through the reduction of medication administration errors.

Evaluation and review of the safety management system implementation in the Royal Thai Air Force

NASA Astrophysics Data System (ADS)

Chaiwan, Sakkarin

This study was designed to determine situation and effectiveness of the safety management system currently implemented in the Royal Thai Air Force. Reviewing the ICAO's SMS and the RTAF's SMS was conducted to identify similarities and differences between the two safety management systems. Later, the researcher acquired safety statistics from the RTAF Safety Center to investigate effectiveness of its safety system. The researcher also collected data to identify other factors affecting effectiveness of the safety system during conducting in-depth interviews. Findings and Conclusions: The study shows that the Royal Thai Air Force has never applied the International Civil Aviation Organization's Safety management System to its safety system. However, the RTAF's SMS and the ICAO's SMS have been developed based on the same concepts. These concepts are from Richard H. Woods's book, Aviation safety programs: A management handbook. However, the effectiveness of the Royal Thai Air Force's safety system is in good stance. An accident rate has been decreasing regularly but there are no known factors to describe the increasing rate, according to the participants' opinion. The participants have informed that there are many issues to be resolved to improve the RTAF's safety system. Those issues are cooperation among safety center's staffs, attitude toward safety of the RTAF senior commanders, and safety standards.

Frequency, Expected Effects, Obstacles, and Facilitators of Disclosure of Patient Safety Incidents: A Systematic Review

PubMed Central

2017-01-01

Objectives We performed a systematic review to assess and aggregate the available evidence on the frequency, expected effects, obstacles, and facilitators of disclosure of patient safety incidents (DPSI). Methods We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for this systematic review and searched PubMed, Scopus, and the Cochrane Library for English articles published between 1990 and 2014. Two authors independently conducted the title screening and abstract review. Ninety-nine articles were selected for full-text reviews. One author extracted the data and another verified them. Results There was considerable variation in the reported frequency of DPSI among medical professionals. The main expected effects of DPSI were decreased intention of the general public to file medical lawsuits and punish medical professionals, increased credibility of medical professionals, increased intention of patients to revisit and recommend physicians or hospitals, higher ratings of quality of care, and alleviation of feelings of guilt among medical professionals. The obstacles to DPSI were fear of medical lawsuits and punishment, fear of a damaged professional reputation among colleagues and patients, diminished patient trust, the complexity of the situation, and the absence of a patient safety culture. However, the factors facilitating DPSI included the creation of a safe environment for reporting patient safety incidents, as well as guidelines and education for DPSI. Conclusions The reported frequency of the experience of the general public with DPSI was somewhat lower than the reported frequency of DPSI among medical professionals. Although we identified various expected effects of DPSI, more empirical evidence from real cases is required. PMID:28372351

Identification and description of randomized controlled trials and systematic reviews on patient safety published in medical journals.

PubMed

Barajas-Nava, Leticia Andrea; Calvache, José Andrés; López-Alcalde, Jesús; Solà, Ivan; Cosp, Xavier Bonfill

2013-06-01

To identify and describe randomized controlled trials (RCTs) and systematic reviews (SRs) on patient safety published from 1973 onward. We handsearched a total of 12 medical journals published in English with contents related to patient safety to identify RCTs and SRs published between 1973 and the end of 2010. The results obtained from this search were complemented with an additional search in MEDLINE. The documents were classified by area of specialty or service in which the intervention was applied, level of preventive action, and type of patient safety incident, the latter in accordance with the International Classification for Patient Safety proposed by the World Health Organization (WHO). The main features of the identified studies are also described. A total of 787 issues of 12 journals published between 1973 and 2010 were handsearched. This procedure yielded 10,162 references, of which, 131 corresponded to RCTs and 127 to SRs. A parallel MEDLINE search identified only about two-thirds of these articles. Of all the studies identified, 83 RCTs and 64 SRs addressed interventions related to patient safety. The types of incident related to patient safety that were included most often in RCTs involved the clinical process, and for SRs, those related to resources/organizational management. On average, only 3.5 RCTs and 3.4 SRs were published per year, many of which had significant deficiencies in the reported information, such as, for instance, a lack of details on the methodology used. The number of RCTs and SRs on patient safety published in specialized journals is scarce. No studies on interventions to improve the safety of the handling of blood and derivatives, infections related to health care, nutrition, or infrastructure were identified as a result of our search. Handsearching plays a key role in the identification of all the clinical trials that could be included in SRs on patient safety interventions. Knowing the content of RCTs and SRs published on

Notification: Efficiency of the Chemical Safety Board (CSB) Investigation Process

EPA Pesticide Factsheets

October 17, 2012. The EPA OIG plans to begin fieldwork with a modified objective from our May 15, 2012, preliminary research objective on the U.S. Chemical Safety and Hazard Investigation Board’s (CSB’s) investigation process.

49 CFR 385.327 - May a new entrant request an administrative review of a determination of a failed safety audit?

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 5 2014-10-01 2014-10-01 false May a new entrant request an administrative review of a determination of a failed safety audit? 385.327 Section 385.327 Transportation Other Regulations... Program § 385.327 May a new entrant request an administrative review of a determination of a failed safety...

49 CFR 385.327 - May a new entrant request an administrative review of a determination of a failed safety audit?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false May a new entrant request an administrative review of a determination of a failed safety audit? 385.327 Section 385.327 Transportation Other Regulations... Program § 385.327 May a new entrant request an administrative review of a determination of a failed safety...

49 CFR 385.327 - May a new entrant request an administrative review of a determination of a failed safety audit?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 5 2013-10-01 2013-10-01 false May a new entrant request an administrative review of a determination of a failed safety audit? 385.327 Section 385.327 Transportation Other Regulations... Program § 385.327 May a new entrant request an administrative review of a determination of a failed safety...

49 CFR 385.327 - May a new entrant request an administrative review of a determination of a failed safety audit?

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 5 2012-10-01 2012-10-01 false May a new entrant request an administrative review of a determination of a failed safety audit? 385.327 Section 385.327 Transportation Other Regulations... Program § 385.327 May a new entrant request an administrative review of a determination of a failed safety...

Understanding the Federal Proposal Review Process.

ERIC Educational Resources Information Center

Cavin, Janis I.

Information on the peer review process for the evaluation of federal grant proposals is presented to help college grants administrators and faculty develop good proposals. This guidebook provides an overview of the policies and conventions that govern the review and selection of proposals for funding, and details the review procedures of the…

From the traditional concept of safety management to safety integrated with quality.

PubMed

García Herrero, Susana; Mariscal Saldaña, Miguel Angel; Manzanedo del Campo, Miguel Angel; Ritzel, Dale O

2002-01-01

This editorial reviews the evolution of the concepts of safety and quality that have been used in the traditional workplace. The traditional programs of safety are explored showing strengths and weaknesses. The concept of quality management is also viewed. Safety management and quality management principles, stages, and measurement are highlighted. The concepts of quality and safety guarantee are assessed. Total Quality Management concepts are reviewed and applied to safety quality. Total safety management principles are discussed. Finally, an analysis of the relationship between quality and safety from data collected from a company in Spain is presented.

Behavioral risk factors associated with listeriosis in the home: a review of consumer food safety studies.

PubMed

Evans, Ellen W; Redmond, Elizabeth C

2014-03-01

Listeria monocytogenes causes human listeriosis, which is associated with the highest hospitalization and mortality rates of all foodborne illnesses. In recent years, the incidence of listeriosis has doubled in Europe, almost exclusively among older adults (≥ 60 years of age). Food safety factors associated with increased risk of listeriosis include lack of adherence to "use by" dates and ineffective refrigerated storage of foods. Consequently, older adult consumers' implementation of safe food practices should be evaluated. This article is a review of consumer food safety cognitive and behavioral data relating to risk factors associated with listeriosis in the home as reported in 165 consumer food safety studies. Overall, only 41% of studies included assessment of consumer cognitive or behavioral data associated with listeriosis; of these studies 59% included data on safe refrigeration, 54% included data on storage time for opened ready-to-eat foods, and 49% included data on adherence to use-by dates. In most (83%) of the studies, survey-based data collection methods (questionnaires/interviews) were used; thus, the majority of findings were based on self-report (74%) and knowledge (44%). Observation (31%) and focus groups (12%) were less commonly used, resulting in a lack of actual behaviors and attitudinal data relating to listeriosis risk factors. Only 7% of studies included food safety data for older adults. Although older adults may fail to implement recommended practices, this review reveals a need for in-depth research to determine food safety attitudes and actual behaviors of older adults in conjunction with knowledge and selfreport of practices linked to increased risks of listeriosis. Such data combined with review findings would inform targeted food safety education to reduce risks associated with listeriosis in the home.

A systematic review of safety data reporting in clinical trials of vaccines against malaria, tuberculosis, and human immunodeficiency virus.

PubMed

Tamminga, Cindy; Kavanaugh, Michael; Fedders, Charlotte; Maiolatesi, Santina; Abraham, Neethu; Bonhoeffer, Jan; Heininger, Ulrich; Vasquez, Carlos S; Moorthy, Vasee S; Epstein, Judith E; Richie, Thomas L

2013-08-02

Malaria, tuberculosis (TB) and human immunodeficiency virus (HIV) are diseases with devastating effects on global public health, especially in the developing world. Clinical trials of candidate vaccines for these diseases are being conducted at an accelerating rate, and require accurate and consistent methods for safety data collection and reporting. We performed a systematic review of publications describing the safety results from clinical trials of malaria, TB and HIV vaccines, to ascertain the nature and consistency of safety data collection and reporting. The target for the review was pre-licensure trials for malaria, TB and HIV vaccines published in English from 2000 to 2009. Search strategies were customized for each of the databases utilized (MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews and the Database of Reviews and Effects). Data extracted included age of trial participants, vaccine platform, route and method of vaccine administration, duration of participant follow-up, reporting of laboratory abnormalities, and the type, case definitions, severity, reporting methods and internal reporting consistency of adverse events. Of 2278 publications screened, 124 were eligible for inclusion (malaria: 66, TB: 9, HIV: 49). Safety data reporting was found to be highly variable among publications and often incomplete: overall, 269 overlapping terms were used to describe specific adverse events. 17% of publications did not mention fever. Descriptions of severity or degree of relatedness to immunization of adverse events were frequently omitted. 26% (32/124) of publications failed to report data on serious adverse events. The review demonstrated lack of standardized safety data reporting in trials for vaccines against malaria, TB and HIV. Standardization of safety data collection and reporting should be encouraged to improve data quality and comparability. The search strategy missed studies published in languages other than English and excluded studies

Perspectives of The Interagency Nuclear Safety Review Panel (INSRP) on future nuclear powered space missions

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

Gray, L.B.; Pyatt, D.W.; Sholtis, J.A.

1993-01-10

The Interagency Nuclear Safety Review Panel (INSRP) has provided reviews of all nuclear powered spacecraft launched by the United States. The two most recent launches were Ulysses in 1990 and Galileo in 1989. One reactor was launched in 1965 (SNAP-10A). All other U.S. space missions have utilized radioisotopic thermoelectric generators (RTGs). There are several missions in the next few years that are to be nuclear powered, including one that would utilize the Topaz II reactor purchased from Russia. INSRP must realign itself to perform parallel safety assessments of a reactor powered space mission, which has not been done in aboutmore » thirty years, and RTG powered missions.« less

Another Approach to Enhance Airline Safety: Using Management Safety Tools

NASA Technical Reports Server (NTRS)

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

2006-01-01

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

Innovative safety valve selection techniques and data.

PubMed

Miller, Curt; Bredemyer, Lindsey

2007-04-11

The new valve data resources and modeling tools that are available today are instrumental in verifying that that safety levels are being met in both current installations and project designs. If the new ISA 84 functional safety practices are followed closely, good industry validated data used, and a user's maintenance integrity program strictly enforced, plants should feel confident that their design has been quantitatively reinforced. After 2 years of exhaustive reliability studies, there are now techniques and data available to support this safety system component deficiency. Everyone who has gone through the process of safety integrity level (SIL) verification (i.e. reliability math) will appreciate the progress made in this area. The benefits of these advancements are improved safety with lower lifecycle costs such as lower capital investment and/or longer testing intervals. This discussion will start with a review of the different valve, actuator, and solenoid/positioner combinations that can be used and their associated application restraints. Failure rate reliability studies (i.e. FMEDA) and data associated with the final combinations will then discussed. Finally, the impact of the selections on each safety system's SIL verification will be reviewed.

Evaluating the safety and dosing of drugs in patients with liver cirrhosis by literature review and expert opinion.

PubMed

Weersink, Rianne A; Bouma, Margriet; Burger, David M; Drenth, Joost P H; Hunfeld, Nicole G M; Kranenborg, Minke; Monster-Simons, Margje H; van Putten, Sandra A W; Metselaar, Herold J; Taxis, Katja; Borgsteede, Sander D

2016-10-12

Liver cirrhosis can have a major impact on drug pharmacokinetics and pharmacodynamics. Patients with cirrhosis often suffer from potentially preventable adverse drug reactions. Guidelines on safe prescribing for these patients are lacking. The aim of this study is to develop a systematic method for evaluating the safety and optimal dosage of drugs in patients with liver cirrhosis. For each drug, a six-step evaluation process will be followed. (1) Available evidence on the pharmacokinetics and safety of a drug in patients with liver cirrhosis will be collected from the Summary of Product Characteristics (SmPC) and a systematic literature review will be performed. (2) Data regarding two outcomes, namely pharmacokinetics and safety, will be extracted and presented in a standardised assessment report. (3) A safety classification and dosage suggestion will be proposed for each drug. (4) An expert panel will discuss the validity and clinical relevance of this suggested advice. (5) Advices will be implemented in all relevant Clinical Decision Support Systems in the Netherlands and published on a website for patients and healthcare professionals. (6) The continuity of the advices will be guaranteed by a yearly check of new literature and comments on the advices. This protocol will be applied in the evaluation of a selection of drugs: (A) drugs used to treat (complications of) liver cirrhosis, and (B) drugs frequently prescribed to the general population. Since this study does not directly involve human participants, it does not require ethical clearance. Besides implementation on a website and in clinical decision support systems, we aim to publish the generated advices of one or two drug classes in a peer-reviewed journal and at conference meetings. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Evaluating the safety and dosing of drugs in patients with liver cirrhosis by literature review and expert opinion

PubMed Central

Weersink, Rianne A; Bouma, Margriet; Burger, David M; Drenth, Joost P H; Hunfeld, Nicole G M; Kranenborg, Minke; Monster-Simons, Margje H; van Putten, Sandra A W; Metselaar, Herold J; Taxis, Katja; Borgsteede, Sander D

2016-01-01

Introduction Liver cirrhosis can have a major impact on drug pharmacokinetics and pharmacodynamics. Patients with cirrhosis often suffer from potentially preventable adverse drug reactions. Guidelines on safe prescribing for these patients are lacking. The aim of this study is to develop a systematic method for evaluating the safety and optimal dosage of drugs in patients with liver cirrhosis. Methods and analysis For each drug, a six-step evaluation process will be followed. (1) Available evidence on the pharmacokinetics and safety of a drug in patients with liver cirrhosis will be collected from the Summary of Product Characteristics (SmPC) and a systematic literature review will be performed. (2) Data regarding two outcomes, namely pharmacokinetics and safety, will be extracted and presented in a standardised assessment report. (3) A safety classification and dosage suggestion will be proposed for each drug. (4) An expert panel will discuss the validity and clinical relevance of this suggested advice. (5) Advices will be implemented in all relevant Clinical Decision Support Systems in the Netherlands and published on a website for patients and healthcare professionals. (6) The continuity of the advices will be guaranteed by a yearly check of new literature and comments on the advices. This protocol will be applied in the evaluation of a selection of drugs: (A) drugs used to treat (complications of) liver cirrhosis, and (B) drugs frequently prescribed to the general population. Ethics and dissemination Since this study does not directly involve human participants, it does not require ethical clearance. Besides implementation on a website and in clinical decision support systems, we aim to publish the generated advices of one or two drug classes in a peer-reviewed journal and at conference meetings. PMID:27733414

Illuminating e-beam processing

USDA-ARS?s Scientific Manuscript database

This month's Processing column will explore electronic beam (e-beam) processing. E-beam processing uses a low energy form of irradiation and has emerged as a highly promising treatment for both food safety and quarantine purposes. It is also used to extend food shelf life. This column will review...

Safety of ingredients used in cosmetics.

PubMed

Bergfeld, Wilma F; Belsito, Donald V; Marks, James G; Andersen, F Alan

2005-01-01

completed in the early days of the program. To consider new data, the CIR Expert Panel has instituted a re-review program. Sodium lauryl sulfate (SLS), formaldehyde, and parabens are discussed as examples. Safety assessments currently underway are listed, along with high-priority ingredients from which new work will be chosen. Although supported by the cosmetics industry, the CIR program has remained independent in its decision making, based on its open, public process; the integrity of the expert panel members; the participation of the FDA and the CFA; and the cooperation of the cosmetics industry.

Advanced Test Reactor Safety Basis Upgrade Lessons Learned Relative to Design Basis Verification and Safety Basis Management

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

G. L. Sharp; R. T. McCracken

The Advanced Test Reactor (ATR) is a pressurized light-water reactor with a design thermal power of 250 MW. The principal function of the ATR is to provide a high neutron flux for testing reactor fuels and other materials. The reactor also provides other irradiation services such as radioisotope production. The ATR and its support facilities are located at the Test Reactor Area of the Idaho National Engineering and Environmental Laboratory (INEEL). An audit conducted by the Department of Energy's Office of Independent Oversight and Performance Assurance (DOE OA) raised concerns that design conditions at the ATR were not adequately analyzedmore » in the safety analysis and that legacy design basis management practices had the potential to further impact safe operation of the facility.1 The concerns identified by the audit team, and issues raised during additional reviews performed by ATR safety analysts, were evaluated through the unreviewed safety question process resulting in shutdown of the ATR for more than three months while these concerns were resolved. Past management of the ATR safety basis, relative to facility design basis management and change control, led to concerns that discrepancies in the safety basis may have developed. Although not required by DOE orders or regulations, not performing design basis verification in conjunction with development of the 10 CFR 830 Subpart B upgraded safety basis allowed these potential weaknesses to be carried forward. Configuration management and a clear definition of the existing facility design basis have a direct relation to developing and maintaining a high quality safety basis which properly identifies and mitigates all hazards and postulated accident conditions. These relations and the impact of past safety basis management practices have been reviewed in order to identify lessons learned from the safety basis upgrade process and appropriate actions to resolve possible concerns with respect to the current ATR

A review for identification of initiating events in event tree development process on nuclear power plants

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

Riyadi, Eko H., E-mail: e.riyadi@bapeten.go.id

2014-09-30

Initiating event is defined as any event either internal or external to the nuclear power plants (NPPs) that perturbs the steady state operation of the plant, if operating, thereby initiating an abnormal event such as transient or loss of coolant accident (LOCA) within the NPPs. These initiating events trigger sequences of events that challenge plant control and safety systems whose failure could potentially lead to core damage or large early release. Selection for initiating events consists of two steps i.e. first step, definition of possible events, such as by evaluating a comprehensive engineering, and by constructing a top level logicmore » model. Then the second step, grouping of identified initiating event's by the safety function to be performed or combinations of systems responses. Therefore, the purpose of this paper is to discuss initiating events identification in event tree development process and to reviews other probabilistic safety assessments (PSA). The identification of initiating events also involves the past operating experience, review of other PSA, failure mode and effect analysis (FMEA), feedback from system modeling, and master logic diagram (special type of fault tree). By using the method of study for the condition of the traditional US PSA categorization in detail, could be obtained the important initiating events that are categorized into LOCA, transients and external events.« less

Physical Activity and Safety From Crime Among Adults: A Systematic Review.

PubMed

da Silva, Inacio C; Payne, Valerie L; Hino, Adriano Akira; Varela, Andrea Ramirez; Reis, Rodrigo S; Ekelund, Ulf; Hallal, Pedro C

2016-06-01

The aim of this study was to review the evidence to date on the association between physical activity and safety from crime. Articles with adult populations of 500+ participants investigating the association between physical activity and safety from crime were included. A methodological quality assessment was conducted using an adapted version of the Downs and Black checklist. The literature search identified 15,864 articles. After assessment of titles, abstracts and full-texts, 89 articles were included. Most articles (84.3%) were derived from high-income countries and only 3 prospective articles were identified. Articles presented high methodological quality. In 38 articles (42.7%), at least one statistically significant association in the expected direction was reported (ie, safety from crime was positively associated with physical activity). Nine articles (10.1%) found an association in the unexpected direction and 42 (47.2%) did not find statistically significant associations. The results did not change when we analyzed articles separately by sex, age, type of measurement, or domains of physical activity evaluated. The current evidence, mostly based on cross-sectional studies, suggests a lack of association between physical activity and safety from crime. Prospective studies and natural experiments are needed, particularly in areas with wide crime variability.

In-Office Endoscopic Laryngeal Laser Procedures: A Patient Safety Initiative.

PubMed

Anderson, Jennifer; Bensoussan, Yael; Townsley, Richard; Kell, Erika

2018-05-01

Objective To review complications of in-office endoscopic laryngeal laser procedures after implementation of standardized safety protocol. Methods A retrospective review was conducted of the first 2 years of in-office laser procedures at St Michaels Hospital after the introduction of a standardized safety protocol. The protocol included patient screening, procedure checklist with standardized reporting of processes, medications, and complications. Primary outcomes measured were complication rates of in-office laryngeal laser procedures. Secondary outcomes included hemodynamic changes, local anesthetic dose, laser settings, total laser/procedure time, and incidence of sedation. Results A total of 145 in-office KTP procedures performed on 65 patients were reviewed. In 98% of cases, the safety protocol was fully implemented. The overall complication rate was 4.8%. No major complications were encountered. Minor complications included vasovagal episodes and patient intolerance. The rate of patient intolerance resulting early termination of anticipated procedure was 13.1%. Total local anesthetic dose averaged 172.9 mg lidocaine per procedure. The mean amount of laser energy dispersed was 261.2 J, with mean total procedure time of 48.3 minutes. Sixteen percent of patients had preprocedure sedation. Vital signs were found to vary modestly. Systolic blood pressure was lower postprocedure in 13.8% and symptomatic in 4.1%. Discussion The review of our standardized safety protocol has revealed that in-office laser treatment for laryngeal pathology has extremely low complication rates with safe patient outcomes. Implications for Practice The trend of shifting procedures out of the operating room into the office/clinic setting requires new processes designed to promote patient safety.

Standardized Review and Approval Process for High-Cost Medication Use Promotes Value-Based Care in a Large Academic Medical System.

PubMed

Durvasula, Raghu; Kelly, Janet; Schleyer, Anneliese; Anawalt, Bradley D; Somani, Shabir; Dellit, Timothy H

2018-04-01

As healthcare costs rise and reimbursements decrease, healthcare organization leadership and clinical providers must collaborate to provide high-value healthcare. Medications are a key driver of the increasing cost of healthcare, largely as a result of the proliferation of expensive specialty drugs, including biologic agents. Such medications contribute significantly to the inpatient diagnosis-related group payment system, often with minimal or unproved benefit over less-expensive therapies. To describe a systematic review process to reduce non-evidence-based inpatient use of high-cost medications across a large multihospital academic health system. We created a Pharmacy & Therapeutics subcommittee consisting of clinicians, pharmacists, and an ethics representative. This committee developed a standardized process for a timely review (<48 hours) and approval of high-cost medications based on their clinical effectiveness, safety, and appropriateness. The engagement of clinical experts in the development of the consensus-based guidelines for the use of specific medications facilitated the clinicians' acceptance of the review process. Over a 2-year period, a total of 85 patient-specific requests underwent formal review. All reviews were conducted within 48 hours. This review process has reduced the non-evidence-based use of specialty medications and has resulted in a pharmacy savings of $491,000 in fiscal year 2016, with almost 80% of the savings occurring in the last 2 quarters, because our process has matured. The creation of a collaborative review process to ensure consistent, evidence-based utilization of high-cost medications provides value-based care, while minimizing unnecessary practice variation and reducing the cost of inpatient care.

Standardized Review and Approval Process for High-Cost Medication Use Promotes Value-Based Care in a Large Academic Medical System

PubMed Central

Durvasula, Raghu; Kelly, Janet; Schleyer, Anneliese; Anawalt, Bradley D.; Somani, Shabir; Dellit, Timothy H.

2018-01-01

Background As healthcare costs rise and reimbursements decrease, healthcare organization leadership and clinical providers must collaborate to provide high-value healthcare. Medications are a key driver of the increasing cost of healthcare, largely as a result of the proliferation of expensive specialty drugs, including biologic agents. Such medications contribute significantly to the inpatient diagnosis-related group payment system, often with minimal or unproved benefit over less-expensive therapies. Objective To describe a systematic review process to reduce non–evidence-based inpatient use of high-cost medications across a large multihospital academic health system. Methods We created a Pharmacy & Therapeutics subcommittee consisting of clinicians, pharmacists, and an ethics representative. This committee developed a standardized process for a timely review (<48 hours) and approval of high-cost medications based on their clinical effectiveness, safety, and appropriateness. The engagement of clinical experts in the development of the consensus-based guidelines for the use of specific medications facilitated the clinicians' acceptance of the review process. Results Over a 2-year period, a total of 85 patient-specific requests underwent formal review. All reviews were conducted within 48 hours. This review process has reduced the non–evidence-based use of specialty medications and has resulted in a pharmacy savings of $491,000 in fiscal year 2016, with almost 80% of the savings occurring in the last 2 quarters, because our process has matured. Conclusion The creation of a collaborative review process to ensure consistent, evidence-based utilization of high-cost medications provides value-based care, while minimizing unnecessary practice variation and reducing the cost of inpatient care.

Toward a national core course in agricultural medicine and curriculum in agricultural safety and health: the "building capacity" consensus process.

PubMed

Rudolphi, Josie M; Donham, Kelley J

2015-01-01

ABSTRACT The agricultural industry poses specific hazards and risks to its workers. Since the 1970s, the University of Iowa has been establishing programs to educate rural health care and safety professionals who in turn provide education and occupational health and safety services to farm families and farm workers. This program has been well established in the state of Iowa as a program of Iowa's Center for Agricultural Safety and Health (I-CASH). However, the National 1989 Agriculture at Risk Report indicated there was a great need for agricultural medicine training beyond Iowa's borders. In order to help meet this need, Building Capacity: A National Resource of Agricultural Medicine Professionals was initiated as a project of the National Institute for Occupational Safety and Health (NIOSH)-funded Great Plains Center for Agricultural Health in 2006. Before the first phase of this project, a consensus process was conducted with a group of safety and health professionals to determine topics and learning objectives for the course. Over 300 students attended and matriculated the agricultural medicine course during first phase of the project (2007-2010). Beginning the second phase of the project (2012-2016), an expanded advisory committee (38 internationally recognized health and safety professionals) was convened to review the progress of the first phase, make recommendations for revisions to the required topics and competencies, and discuss updates to the second edition of the course textbook (Agricultural Medicine: Occupational and Environmental Health for the Health Professions). A formal consensus process was held and included an online survey and also a face-to-face meeting. The group was charged with the responsibility of developing the next version of this course by establishing best practices and setting an agenda with the long-term goal of developing a national course in agricultural medicine.

Burn injury models of care: A review of quality and cultural safety for care of Indigenous children.

PubMed

Fraser, Sarah; Grant, Julian; Mackean, Tamara; Hunter, Kate; Holland, Andrew J A; Clapham, Kathleen; Teague, Warwick J; Ivers, Rebecca Q

2018-05-01

Safety and quality in the systematic management of burn care is important to ensure optimal outcomes. It is not clear if or how burn injury models of care uphold these qualities, or if they provide a space for culturally safe healthcare for Indigenous peoples, especially for children. This review is a critique of publically available models of care analysing their ability to facilitate safe, high-quality burn care for Indigenous children. Models of care were identified and mapped against cultural safety principles in healthcare, and against the National Health and Medical Research Council standard for clinical practice guidelines. An initial search and appraisal of tools was conducted to assess suitability of the tools in providing a mechanism to address quality and cultural safety. From the 53 documents found, 6 were eligible for review. Aspects of cultural safety were addressed in the models, but not explicitly, and were recorded very differently across all models. There was also limited or no cultural consultation documented in the models of care reviewed. Quality in the documents against National Health and Medical Research Council guidelines was evident; however, description or application of quality measures was inconsistent and incomplete. Gaps concerning safety and quality in the documented care pathways for Indigenous peoples' who sustain a burn injury and require burn care highlight the need for investigation and reform of current practices. Copyright © 2017 Elsevier Ltd and ISBI. All rights reserved.

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

PubMed

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

2012-06-01

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

Food safety and organic meats.

PubMed

Van Loo, Ellen J; Alali, Walid; Ricke, Steven C

2012-01-01

The organic meat industry in the United States has grown substantially in the past decade in response to consumer demand for nonconventionally produced products. Consumers are often not aware that the United States Department of Agriculture (USDA) organic standards are based only on the methods used for production and processing of the product and not on the product's safety. Food safety hazards associated with organic meats remain unclear because of the limited research conducted to determine the safety of organic meat from farm-to-fork. The objective of this review is to provide an overview of the published results on the microbiological safety of organic meats. In addition, antimicrobial resistance of microbes in organic food animal production is addressed. Determining the food safety risks associated with organic meat production requires systematic longitudinal studies that quantify the risks of microbial and nonmicrobial hazards from farm-to-fork.

Modular Chemical Process Intensification: A Review.

PubMed

Kim, Yong-Ha; Park, Lydia K; Yiacoumi, Sotira; Tsouris, Costas

2017-06-07

Modular chemical process intensification can dramatically improve energy and process efficiencies of chemical processes through enhanced mass and heat transfer, application of external force fields, enhanced driving forces, and combinations of different unit operations, such as reaction and separation, in single-process equipment. These dramatic improvements lead to several benefits such as compactness or small footprint, energy and cost savings, enhanced safety, less waste production, and higher product quality. Because of these benefits, process intensification can play a major role in industrial and manufacturing sectors, including chemical, pulp and paper, energy, critical materials, and water treatment, among others. This article provides an overview of process intensification, including definitions, principles, tools, and possible applications, with the objective to contribute to the future development and potential applications of modular chemical process intensification in industrial and manufacturing sectors. Drivers and barriers contributing to the advancement of process intensification technologies are discussed.

78 FR 17233 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Process...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-20

... ACTION: Notice. SUMMARY: The Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) titled, ``Process Safety Management of...., permitting electronic submission of responses. Agency: DOL-OSHA. Title of Collection: Process Safety...

Improving health care quality and safety: the role of collective learning.

PubMed

Singer, Sara J; Benzer, Justin K; Hamdan, Sami U

2015-01-01

Despite decades of effort to improve quality and safety in health care, this goal feels increasingly elusive. Successful examples of improvement are infrequently replicated. This scoping review synthesizes 76 empirical or conceptual studies (out of 1208 originally screened) addressing learning in quality or safety improvement, that were published in selected health care and management journals between January 2000 and December 2014 to deepen understanding of the role that collective learning plays in quality and safety improvement. We categorize learning activities using a theoretical model that shows how leadership and environmental factors support collective learning processes and practices, and in turn team and organizational improvement outcomes. By focusing on quality and safety improvement, our review elaborates the premise of learning theory that leadership, environment, and processes combine to create conditions that promote learning. Specifically, we found that learning for quality and safety improvement includes experimentation (including deliberate experimentation, improvisation, learning from failures, exploration, and exploitation), internal and external knowledge acquisition, performance monitoring and comparison, and training. Supportive learning environments are characterized by team characteristics like psychological safety, appreciation of differences, openness to new ideas social motivation, and team autonomy; team contextual factors including learning resources like time for reflection, access to knowledge, organizational capabilities; incentives; and organizational culture, strategy, and structure; and external environmental factors including institutional pressures, environmental dynamism and competitiveness and learning collaboratives. Lastly learning in the context of quality and safety improvement requires leadership that reinforces learning through actions and behaviors that affect people, such as coaching and trust building, and through

Improving health care quality and safety: the role of collective learning

PubMed Central

Singer, Sara J; Benzer, Justin K; Hamdan, Sami U

2015-01-01

Despite decades of effort to improve quality and safety in health care, this goal feels increasingly elusive. Successful examples of improvement are infrequently replicated. This scoping review synthesizes 76 empirical or conceptual studies (out of 1208 originally screened) addressing learning in quality or safety improvement, that were published in selected health care and management journals between January 2000 and December 2014 to deepen understanding of the role that collective learning plays in quality and safety improvement. We categorize learning activities using a theoretical model that shows how leadership and environmental factors support collective learning processes and practices, and in turn team and organizational improvement outcomes. By focusing on quality and safety improvement, our review elaborates the premise of learning theory that leadership, environment, and processes combine to create conditions that promote learning. Specifically, we found that learning for quality and safety improvement includes experimentation (including deliberate experimentation, improvisation, learning from failures, exploration, and exploitation), internal and external knowledge acquisition, performance monitoring and comparison, and training. Supportive learning environments are characterized by team characteristics like psychological safety, appreciation of differences, openness to new ideas social motivation, and team autonomy; team contextual factors including learning resources like time for reflection, access to knowledge, organizational capabilities; incentives; and organizational culture, strategy, and structure; and external environmental factors including institutional pressures, environmental dynamism and competitiveness and learning collaboratives. Lastly learning in the context of quality and safety improvement requires leadership that reinforces learning through actions and behaviors that affect people, such as coaching and trust building, and through

Safety of treatment options for spondyloarthritis: a narrative review.

PubMed

D'Angelo, Salvatore; Carriero, Antonio; Gilio, Michele; Ursini, Francesco; Leccese, Pietro; Palazzi, Carlo

2018-05-01

Spondyloarthritis (SpA) are chronic inflammatory diseases with overlapping pathogenic mechanisms and clinical features. Treatment armamentarium against SpA includes non-steroidal anti-inflammatory drugs, glucocorticoids, conventional disease-modifying antirheumatic drugs (DMARDs, including sulfasalazine, methotrexate, leflunomide, cyclosporine), targeted synthetic DMARDs (apremilast) and biological DMARDs (TNF inhibitors, anti-IL 12/23 and anti-IL-17 agents). Areas covered: A narrative review of published literature on safety profile of available SpA treatment options was performed. Readers will be provided with a comprehensive overview on frequent and rare adverse events associated with each drug listed in current SpA treatment recommendations. Expert opinion: The overall safety profile of such molecules is good and serious adverse events are rare but need to be promptly recognized and treated. However, the monitoring of adverse events is a major challenge for clinicians because it is not adequately addressed by current treatment recommendations. A tailored treatment is crucial and rheumatologists must accurately select patients in order to identify those more susceptible to develop adverse events.

Efficacy and safety of novel antipsychotics: a critical review.

PubMed

Balestrieri, Matteo; Vampini, Claudio; Bellantuono, Cesario

2000-10-01

Efficacy and safety of novel antipsychotic (AP) drugs (amisulpride, olanzapine, quetiapine, ziprasidone and zotepine) have been reviewed. Data on their antipsychotic efficacy and side effects profile have been evaluated only on the basis of controlled trials so far published. Overall, all these drugs have shown an antipsychotic efficacy on positive symptoms of schizophrenia similar to that of the conventional AP drugs. On negative symptoms, all novel AP drugs, except quetiapine and ziprasidone, demonstrated a better efficacy than haloperidol. Long-term efficacy of these AP drugs in the maintenance treatment of schizophrenia needs to be explored by further, better-designed, epidemiological studies. The safety profile shows that the novel AP drugs are generally well-tolerated and induce significantly less acute extrapyramidal side effects in comparison with haloperidol. Some methodological flaws in the experimental design of the clinical trials analysed are discussed. Although these novel AP drugs have potential clinical advantages, a number of relevant questions still remain to be addressed, in order to establish the impact of these drugs in the overall treatment of schizophrenia. Copyright 2000 John Wiley & Sons, Ltd.

Exploratory Analyses of the Effects of Managerial Support and Feedback Consequences on Behavioral Safety Maintenance

ERIC Educational Resources Information Center

Cooper, M. Dominic

2006-01-01

Reviews indicate management commitment is vital to maintain behavioral safety processes. Similarly, the impact of observation frequency on safety behaviors is thought to be important. An employee-driven process which encompassed behavioral observations, goal-setting, and feedback was implemented in a paper mill with 55 workgroups using a…

Macroergonomics in Healthcare Quality and Patient Safety

PubMed Central

Carayon, Pascale; Karsh, Ben-Tzion; Gurses, Ayse P.; Holden, Richard; Hoonakker, Peter; Hundt, Ann Schoofs; Montague, Enid; Rodriguez, Joy; Wetterneck, Tosha B.

2014-01-01

The US Institute of Medicine and healthcare experts have called for new approaches to manage healthcare quality problems. In this chapter, we focus on macroergonomics, a branch of human factors and ergonomics that is based on the systems approach and considers the organizational and sociotechnical context of work activities and processes. Selected macroergonomic approaches to healthcare quality and patient safety are described such as the SEIPS model of work system and patient safety and the model of healthcare professional performance. Focused reviews on job stress and burnout, workload, interruptions, patient-centered care, health IT and medical devices, violations, and care coordination provide examples of macroergonomics contributions to healthcare quality and patient safety. Healthcare systems and processes clearly need to be systematically redesigned; examples of macroergonomic approaches, principles and methods for healthcare system redesign are described. Further research linking macroergonomics and care processes/patient outcomes is needed. Other needs for macroergonomics research are highlighted, including understanding the link between worker outcomes (e.g., safety and well-being) and patient outcomes (e.g., patient safety), and macroergonomics of patient-centered care and care coordination. PMID:24729777

A Review of the Quality and Safety of Irradiated Food.

DTIC Science & Technology

1987-01-01

Construction or Planned.................16 Figure 4: Changes in the Levels of Certain Vitamins in Different Meats Irradiated at High Doses..........24...In the twenty year5 prior to this action, irradiation had been approved for wheat, wheat products, and white potatoes but the process wa- * never used...restriu-t the ujse of . this process or require some type ol labeling. Conumri %>:~ concern about the safety and quality of irradiated food - ha

Automated discovery of safety and efficacy concerns for joint & muscle pain relief treatments from online reviews.

PubMed

Adams, David Z; Gruss, Richard; Abrahams, Alan S

2017-04-01

Product issues can cost companies millions in lawsuits and have devastating effects on a firm's sales, image and goodwill, especially in the era of social media. The ability for a system to detect the presence of safety and efficacy (S&E) concerns early on could not only protect consumers from injuries due to safety hazards, but could also mitigate financial damage to the manufacturer. Prior studies in the field of automated defect discovery have found industry-specific techniques appropriate to the automotive, consumer electronics, home appliance, and toy industries, but have not investigated pain relief medicines and medical devices. In this study, we focus specifically on automated discovery of S&E concerns in over-the-counter (OTC) joint and muscle pain relief remedies and devices. We select a dataset of over 32,000 records for three categories of Joint & Muscle Pain Relief treatments from Amazon's online product reviews, and train "smoke word" dictionaries which we use to score holdout reviews, for the presence of safety and efficacy issues. We also score using conventional sentiment analysis techniques. Compared to traditional sentiment analysis techniques, we found that smoke term dictionaries were better suited to detect product concerns from online consumer reviews, and significantly outperformed the sentiment analysis techniques in uncovering both efficacy and safety concerns, across all product subcategories. Our research can be applied to the healthcare and pharmaceutical industry in order to detect safety and efficacy concerns, reducing risks that consumers face using these products. These findings can be highly beneficial to improving quality assurance and management in joint and muscle pain relief. Copyright © 2017 Elsevier B.V. All rights reserved.

Enhancing patient safety: improving the patient handoff process through appreciative inquiry.

PubMed

Shendell-Falik, Nancy; Feinson, Michael; Mohr, Bernard J

2007-02-01

Patient transfers from one care giver to another are an area of high safety consequence, as is evident by many studies and the Joint Commission on Accreditation of Healthcare Organization's Patient Safety Goals. The authors describe how one hospital made measurable improvements in a patient handoff process by using an unconventional approach to change called appreciative inquiry. Rather than identifying the root causes of ineffective handoffs, appreciative inquiry was used to engage staff in identifying and building on their most effective handoff experiences.

Idaho National Laboratory Integrated Safety Management System FY 2013 Effectiveness Review and Declaration Report

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

Hunt, Farren

2013-12-01

Idaho National Laboratory (INL) performed an Annual Effectiveness Review of the Integrated Safety Management System (ISMS), per 48 Code of Federal Regulations (CFR) 970.5223 1, “Integration of Environment, Safety and Health into Work Planning and Execution.” The annual review assessed Integrated Safety Management (ISM) effectiveness, provided feedback to maintain system integrity, and identified target areas for focused improvements and assessments for Fiscal Year (FY) 2014. Results of the FY 2013 annual effectiveness review demonstrate that the INL’s ISMS program is “Effective” and continually improving and shows signs of being significantly strengthened. Although there have been unacceptable serious events in themore » past, there has also been significant attention, dedication, and resources focused on improvement, lessons learned and future prevention. BEA’s strategy of focusing on these improvements includes extensive action and improvement plans that include PLN 4030, “INL Sustained Operational Improvement Plan, PLN 4058, “MFC Strategic Excellence Plan,” PLN 4141, “ATR Sustained Excellence Plan,” and PLN 4145, “Radiological Control Road to Excellence,” and the development of LWP 20000, “Conduct of Research.” As a result of these action plans, coupled with other assurance activities and metrics, significant improvement in operational performance, organizational competence, management oversight and a reduction in the number of operational events is being realized. In short, the realization of the fifth core function of ISMS (feedback and continuous improvement) and the associated benefits are apparent.« less

Long-acting atypical injectable antipsychotics in the treatment of schizophrenia: safety and tolerability review.

PubMed

Cañas, Fernando; Möller, Hans-Jürgen

2010-09-01

Although atypical antipsychotics have beneficial efficacy and tolerance, non-adherence and partial adherence remain in patients treated for schizophrenia. Long-acting injectable or depot atypical antipsychotics offer better medication adherence and tolerability advantages. Currently, two drugs are available for the treatment of schizophrenia, risperidone long-acting injectable (RLAI) and olanzapine pamoate (OP). Short- and long-term safety and tolerability data on RLAI and OP from January 2006 through September 2009 were reviewed by performing Medline and PubMed searches, reviewing abstracts and poster presentations, and viewing available material from the FDA and European Medicines Agency. RLAI and OP show good short- and long-term safety when treating patients with schizophrenia, with uncommon discontinuation due to adverse effects. RLAI and OP data show rare problems with injection site reactions and patients exposed to injectable treatments prefer to continue injections. Infrequent but serious post-injection delirium sedation syndrome occurred after 1% of OP injections. Weight gain was generally higher among patients treated with OP versus RLAI. Healthcare providers, patients and family members should be made aware of the safety and benefits of long-acting injectable atypical antipsychotics in order to diminish the unnecessary restrictions of these therapies for patients with schizophrenia.

Quality and safety attributes of afghan raisins before and after processing

PubMed Central

McCoy, Stacy; Chang, Jun Won; McNamara, Kevin T; Oliver, Haley F; Deering, Amanda J

2015-01-01

Raisins are an important export commodity for Afghanistan; however, Afghan packers are unable to export to markets seeking high-quality products due to limited knowledge regarding their quality and safety. To evaluate this, Afghan raisin samples from pre-, semi-, and postprocessed raisins were obtained from a raisin packer in Kabul, Afghanistan. The raisins were analyzed and compared to U.S. standards for processed raisins. The samples tested did not meet U.S. industry standards for embedded sand and pieces of stem, total soluble solids, and titratable acidity. The Afghan raisins did meet or exceed U.S. Grade A standard for the number of cap-stems, percent damaged, crystallization levels, moisture content, and color. Following processing, the number of total aerobic bacteria, yeasts, molds, and total coliforms were within the acceptable limits. Although quality issues are present in the Afghan raisins, the process used to clean the raisins is suitable to maintain food safety standards. PMID:25650241

Improving patient safety through quality assurance.

PubMed

Raab, Stephen S

2006-05-01

Anatomic pathology laboratories use several quality assurance tools to detect errors and to improve patient safety. To review some of the anatomic pathology laboratory patient safety quality assurance practices. Different standards and measures in anatomic pathology quality assurance and patient safety were reviewed. Frequency of anatomic pathology laboratory error, variability in the use of specific quality assurance practices, and use of data for error reduction initiatives. Anatomic pathology error frequencies vary according to the detection method used. Based on secondary review, a College of American Pathologists Q-Probes study showed that the mean laboratory error frequency was 6.7%. A College of American Pathologists Q-Tracks study measuring frozen section discrepancy found that laboratories improved the longer they monitored and shared data. There is a lack of standardization across laboratories even for governmentally mandated quality assurance practices, such as cytologic-histologic correlation. The National Institutes of Health funded a consortium of laboratories to benchmark laboratory error frequencies, perform root cause analysis, and design error reduction initiatives, using quality assurance data. Based on the cytologic-histologic correlation process, these laboratories found an aggregate nongynecologic error frequency of 10.8%. Based on gynecologic error data, the laboratory at my institution used Toyota production system processes to lower gynecologic error frequencies and to improve Papanicolaou test metrics. Laboratory quality assurance practices have been used to track error rates, and laboratories are starting to use these data for error reduction initiatives.

Safety of allergen immunotherapy: a review of premedication and dose adjustment.

PubMed

Morris, A Erika; Marshall, Gailen D

2012-03-01

From the first allergen immunotherapy proposed in the early 1900s to the present day, numerous studies have proven the efficacy of allergen immunotherapy for the treatment of allergic rhinitis, allergic conjunctivitis, allergic asthma and stinging insect hypersensitivity. The major risk, however small, with allergen immunotherapy is anaphylaxis. There has been considerable interest and debate regarding risk factors for immunotherapy reactions (local and systemic) and interventions to reduce the occurrence of these reactions. One of these interventions that is especially debated regards dose adjustment for various reasons, but in particular for local reactions. In this review, we discuss the safety of immunotherapy and provide a comprehensive review of the literature regarding immunotherapy schedules and doses.

78 FR 56268 - Pipeline Safety: Public Workshop on Integrity Verification Process, Comment Extension

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-12

.... PHMSA-2013-0119] Pipeline Safety: Public Workshop on Integrity Verification Process, Comment Extension... public workshop on ``Integrity Verification Process'' which took place on August 7, 2013. The notice also sought comments on the proposed ``Integrity Verification Process.'' In response to the comments received...

Good practices on cost - effective road infrastructure safety investments.

PubMed

Yannis, George; Papadimitriou, Eleonora; Evgenikos, Petros; Dragomanovits, Anastasios

2016-12-01

The paper presents the findings of a research project aiming to quantify and subsequently classify several infrastructure-related road safety measures, based on the international experience attained through extensive and selected literature review and additionally on a full consultation process including questionnaire surveys addressed to experts and relevant workshops. Initially, a review of selected research reports was carried out and an exhaustive list of road safety infrastructure investments covering all types of infrastructure was compiled. Individual investments were classified according to the infrastructure investment area and the type of investment and were thereafter analysed on the basis of key safety components. These investments were subsequently ranked in relation to their safety effects and implementation costs and on the basis of this ranking, a set of five most promising investments was selected for an in-depth analysis. The results suggest that the overall cost effectiveness of a road safety infrastructure investment is not always in direct correlation with the safety effect and is recommended that cost-benefit ratios and safety effects are always examined in conjunction with each other in order to identify the optimum solution for a specific road safety problem in specific conditions and with specific objectives.

Medication safety infrastructure in critical-access hospitals in Florida.

PubMed

Winterstein, Almut G; Hartzema, Abraham G; Johns, Thomas E; De Leon, Jessica M; McDonald, Kathie; Henshaw, Zak; Pannell, Robert

2006-03-01

The medication safety infrastructure of critical-access hospitals (CAHs) in Florida was evaluated. Qualitative assessments, including a self-administered survey and site visits, were conducted in seven of nine CAHs between January and June 2003. The survey consisted of the Institute for Safe Medication Practices Medication Safety Self-assessment, the 2003 Joint Commission on Accreditation of Healthcare Organizations patient safety goals, health information technology (HIT) questions, and medication-use-process flow charts. On-site visits included interviews of CAH personnel who had safety responsibility and inspections of pharmacy facilities. The findings were compiled into a matrix reflecting structural and procedural components of the CAH medication safety infrastructure. The nine characteristics that emerged as targets for quality improvement (QI) were medication accessibility and storage, sterile product compounding, access to drug information, access to and utilization of patient information in medication order review, advanced safety technology, drug formularies and standardized medication protocols, safety culture, and medication reconciliation. Based on weighted importance and feasibility, QI efforts in CAHs should focus on enhancing medication order review systems, standardizing procedures for handling high-risk medications, promoting an appropriate safety culture, involvement in seamless care, and investment in HIT.

Design for Review - Applying Lessons Learned to Improve the FPGA Review Process

NASA Technical Reports Server (NTRS)

Figueiredo, Marco A.; Li, Kenneth E.

2014-01-01

Flight Field Programmable Gate Array (FPGA) designs are required to be independently reviewed. This paper provides recommendations to Flight FPGA designers to properly prepare their designs for review in order to facilitate the review process, and reduce the impact of the review time in the overall project schedule.

Integrated Approaches to Occupational Health and Safety: A Systematic Review.

PubMed

Cooklin, A; Joss, N; Husser, E; Oldenburg, B

2017-09-01

The study objective was to conduct a systematic review of the effectiveness of integrated workplace interventions that combine health promotion with occupational health and safety. Electronic databases (n = 8), including PsychInfo and MEDLINE, were systematically searched. Studies included were those that reported on workplace interventions that met the consensus definition of an "integrated approach," published in English, in the scientific literature since 1990. Data extracted were occupation, worksite, country, sample size, intervention targets, follow-up period, and results reported. Quality was assessed according to American College of Occupational and Environmental Medicine Practice Guidelines. Heterogeneity precluded formal meta-analyses. Results were classified according to the outcome(s) assessed into five categories (health promotion, injury prevention, occupational health and safety management, psychosocial, and return-on-investment). Narrative synthesis of outcomes was performed. A total of 31 eligible studies were identified; 23 (74%) were (quasi-)experimental trials. Effective interventions were most of those aimed at improving employee physical or mental health. Less consistent results were reported from integrated interventions targeting occupational health and safety management, injury prevention, or organizational cost savings. Integrated approaches have been posed as comprehensive solutions to complex issues. Empirical evidence, while still emerging, provides some support for this. Continuing investment in, and evaluation of, integrated approaches are worthwhile.

Patient Safety and Quality Improvement in Otolaryngology Education: A Systematic Review.

PubMed

Gettelfinger, John D; Paulk, P Barrett; Schmalbach, Cecelia E

2017-06-01

Objective The breadth and depth of patient safety/quality improvement (PS/QI) research dedicated to otolaryngology-head and neck surgery (OHNS) education remains unknown. This systematic review aims to define this scope and to identify knowledge gaps as well as potential areas of future study to improved PS/QI education and training in OHNS. Data Sources A computerized Ovid/Medline database search was conducted (January 1, 1965, to May 15, 2015). Similar computerized searches were conducted using Cochrane Database, PubMed, and Google Scholar. Review Methods The study protocol was developed a priori using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Articles were classified by year, subspecialty, Institute of Medicine (IOM) Crossing the Chasm categories, and World Health Organization (WHO) subclass. Results Computerized searches yielded 8743 eligible articles, 267 (3.4%) of which met otolaryngology PS/QI inclusion criteria; 51 (19%) were dedicated to resident/fellow education and training. Simulation studies (39%) and performance/competency evaluation (23.5%) were the most common focus. Most projects involved general otolaryngology (47%), rhinology (18%), and otology (16%). Classification by the IOM included effective care (45%), safety/effective care (41%), and effective and efficient care (7.8%). Most research fell into the WHO category of "identifying solutions" (61%). Conclusion Nineteen percent of OHNS PS/QI articles are dedicated to education, the majority of which are simulation and focus on effective care. Knowledges gaps for future research include facial plastics PS/QI and the WHO category of "studies translating evidence into safer care."

Modular Chemical Process Intensification: A Review

DOE PAGES

Kim, Yong-ha; Park, Lydia K.; Yiacoumi, Sotira; ...

2016-06-24

Modular chemical process intensification can dramatically improve energy and process efficiencies of chemical processes through enhanced mass and heat transfer, application of external force fields, enhanced driving forces, and combinations of different unit operations, such as reaction and separation, in single-process equipment. Dramatic improvements such as these lead to several benefits such as compactness or small footprint, energy and cost savings, enhanced safety, less waste production, and higher product quality. Because of these benefits, process intensification can play a major role in industrial and manufacturing sectors, including chemical, pulp and paper, energy, critical materials, and water treatment, among others. Thismore » article provides an overview of process intensification, including definitions, principles, tools, and possible applications, with the objective to contribute to the future development and potential applications of modular chemical process intensification in industrial and manufacturing sectors. Drivers and barriers contributing to the advancement of process intensification technologies are discussed.« less

Scoping Review of Research on the Effectiveness of Food-Safety Education Interventions Directed at Consumers.

PubMed

Sivaramalingam, Bhairavi; Young, Ian; Pham, Mai T; Waddell, Lisa; Greig, Judy; Mascarenhas, Mariola; Papadopoulos, Andrew

2015-07-01

Improper food handling by consumers at home is a major cause of foodborne illness. Therefore, effective education strategies are essential to change consumers' food safety attitudes and behaviors. The purpose of this scoping review was to identify and characterize primary literature examining the effectiveness of consumer food-safety education interventions. Ten bibliographic databases were searched using a comprehensive search strategy. Citations were identified; two reviewers screened them for relevance and characterized relevant articles. To ensure results would be applicable to end users, stakeholders were engaged to provide input on the review scope, methods, and results. We identified 246 relevant articles, of which 150 were quantitative, 66 qualitative, and 30 mixed-method research studies. Most studies (64.2%) were published in the United States, using an uncontrolled before-and-after study design (31.3%), and investigated the effectiveness of community-based training sessions and workshops (52.0%). Research gaps were found in the number of randomized controlled studies conducted, academic- and school-based courses and curricula investigated, and interventions targeting high-risk populations (e.g., pregnant women, those who are immunocompromised) and using new media channels (e.g., social media). Key opportunities to enhance the utility of future primary research investigating consumer food-safety interventions include the following: using studies based on behavior-change theories and formative research; engaging the target population in the research; using validated instruments to measures outcomes; and reporting intervention characteristics and outcomes completely. Results of this review can be used to prioritize future primary research and decision-making in this area.

A fuzzy model for assessing risk of occupational safety in the processing industry.

PubMed

Tadic, Danijela; Djapan, Marko; Misita, Mirjana; Stefanovic, Miladin; Milanovic, Dragan D

2012-01-01

Managing occupational safety in any kind of industry, especially in processing, is very important and complex. This paper develops a new method for occupational risk assessment in the presence of uncertainties. Uncertain values of hazardous factors and consequence frequencies are described with linguistic expressions defined by a safety management team. They are modeled with fuzzy sets. Consequence severities depend on current hazardous factors, and their values are calculated with the proposed procedure. The proposed model is tested with real-life data from fruit processing firms in Central Serbia.

Efficacy, safety, and economics of bracing after spine surgery: a systematic review of the literature.

PubMed

Zhu, Mary P; Tetreault, Lindsay A; Sorefan-Mangou, Fatimah; Garwood, Philip; Wilson, Jefferson R

2018-01-31

Bracing is often used after spinal surgery to immobilize the spine, improve fusion, and relieve pain. However, controversy exists regarding the efficacy, necessity, and safety of various bracing techniques in the postsurgical setting. In this systematic review, we aimed to compare the effectiveness, safety, and cost-effectiveness of postoperative bracing versus no postoperative bracing after spinal surgery in patients with several common operative spinal pathologies. A systematic review was carried out to compare postoperative bracing and no postoperative bracing. A systematic search was conducted of MEDLINE, Embase, and the Cochrane Collaboration Library from 1970 to May 2017, supplemented by manual searching of the reference list of relevant studies and previously published reviews. Studies were included if they compared disability, quality of life, functional impairment, radiographic outcomes, cost-effectiveness, or complications between patients treated with postoperative bracing and patients not receiving any postoperative bracing. Each article was critically appraised independently by two reviewers, and the overall body of evidence was rated using guidelines outlined by the Grading of Recommendation Assessment, Development and Evaluation (GRADE) Working Group. Of the 858 retrieved citations, 5 studies met the inclusion criteria and were included in this review, consisting of 4 randomized controlled trials and 1 prospective cohort study. Low to moderate evidence suggests that there are no significant differences in most measures of disability, pain, quality of life, functional impairment, radiographic outcomes, and safety between groups. Isolated studies reported statistically significant and inconsistent differences between groups with respect to Neck Disability Index at 6 weeks postoperatively or Short Form-36 Physical Component Score at 1.5, 3, 6, and 12 months postoperatively. Based on limited evidence, postoperative bracing does not result in improved

Current advances and trends in electro-Fenton process using heterogeneous catalysts - A review.

PubMed

Poza-Nogueiras, Verónica; Rosales, Emilio; Pazos, Marta; Sanromán, M Ángeles

2018-06-01

Over the last decades, advanced oxidation processes have often been used alone, or combined with other techniques, for remediation of ground and surface water pollutants. The application of heterogeneous catalysis to electrochemical advanced oxidation processes is especially useful due to its efficiency and environmental safety. Among those processes, electro-Fenton stands out as the one in which heterogeneous catalysis has been broadly applied. Thus, this review has introduced an up-to-date collation of the current knowledge of the heterogeneous electro-Fenton process, highlighting recent advances in the use of different catalysts such as iron minerals (pyrite, magnetite or goethite), prepared catalysts by the load of metals in inorganic and organic materials, nanoparticles, and the inclusion of catalysts on the cathode. The effects of physical-chemical parameters as well as the mechanisms involved are critically assessed. Finally, although the utilization of this process to remediation of wastewater overwhelmingly outnumber other utilities, several applications have been described in the context of regeneration of adsorbent or the remediation of soils as clear examples of the feasibility of the electro-Fenton process to solve different environmental problems. Copyright © 2018 Elsevier Ltd. All rights reserved.

Systematic Review of Kinship Care Effects on Safety, Permanency, and Well-Being Outcomes

ERIC Educational Resources Information Center

Winokur, Marc A.; Holtan, Amy; Batchelder, Keri E.

2018-01-01

Objective: Children in out-of-home placements typically display more educational, behavioral, and psychological problems than do their peers. This systematic review evaluated the effect of kinship care placement compared to foster care placement on the safety, permanency, and well-being of children removed from the home for maltreatment. Methods:…

Review of the regulation and safety assessment of food substances in various countries and jurisdictions.

PubMed

Magnuson, Bernadene; Munro, Ian; Abbot, Peter; Baldwin, Nigel; Lopez-Garcia, Rebeca; Ly, Karen; McGirr, Larry; Roberts, Ashley; Socolovsky, Susan

2013-01-01

This review compares the regulations, definitions and approval processes for substances intentionally added to or unintentionally present in human food in the following specific countries/jurisdictions: Argentina, Australia, Brazil, Canada, China, the European Union, Japan, Mexico, New Zealand, and the United States. This includes direct food additives, food ingredients, flavouring agents, food enzymes and/or processing aids, food contact materials, novel foods, and nanoscale materials for food applications. The regulatory authority of each target jurisdiction/country uses its own regulatory framework and although the definitions, regulations and approval processes may vary among all target countries, in general there are many similarities. In all cases, the main purpose of each authority is to establish a regulatory framework and maintain/enforce regulations to ensure that food consumed and sold within its respective countries is safe. There is a move towards harmonisation of food regulations, as illustrated by Australia and New Zealand and by Mercosur. The European Union has also established regulations, which are applicable for all member states, to establish a common authorisation procedure for direct food additives, flavourings and enzymes. Although the path for approval of different categories of food additives varies from jurisdiction to jurisdiction, there are many commonalities in terms of the data requirements and considerations for assessment of the safety of use of food additives, including the use of positive lists of approved substances, pre-market approval, and a separation between science and policy decisions. The principles applied are largely reflective of the early work by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) committees and JECFA assessments of the safety of food additives for human and animal foods.

Review of the regulation and safety assessment of food substances in various countries and jurisdictions

PubMed Central

Magnuson, Bernadene; Munro, Ian; Abbot, Peter; Baldwin, Nigel; Lopez-Garcia, Rebeca; Ly, Karen; McGirr, Larry; Roberts, Ashley; Socolovsky, Susan

2013-01-01

This review compares the regulations, definitions and approval processes for substances intentionally added to or unintentionally present in human food in the following specific countries/jurisdictions: Argentina, Australia, Brazil, Canada, China, the European Union, Japan, Mexico, New Zealand, and the United States. This includes direct food additives, food ingredients, flavouring agents, food enzymes and/or processing aids, food contact materials, novel foods, and nanoscale materials for food applications. The regulatory authority of each target jurisdiction/country uses its own regulatory framework and although the definitions, regulations and approval processes may vary among all target countries, in general there are many similarities. In all cases, the main purpose of each authority is to establish a regulatory framework and maintain/enforce regulations to ensure that food consumed and sold within its respective countries is safe. There is a move towards harmonisation of food regulations, as illustrated by Australia and New Zealand and by Mercosur. The European Union has also established regulations, which are applicable for all member states, to establish a common authorisation procedure for direct food additives, flavourings and enzymes. Although the path for approval of different categories of food additives varies from jurisdiction to jurisdiction, there are many commonalities in terms of the data requirements and considerations for assessment of the safety of use of food additives, including the use of positive lists of approved substances, pre-market approval, and a separation between science and policy decisions. The principles applied are largely reflective of the early work by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) committees and JECFA assessments of the safety of food additives for human and animal foods. PMID:23781843

Phenomenological Studies on Sodium for CSP Applications: A Safety Review

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

Armijo, Kenneth Miguel; Andraka, Charles E.

Sodium as a heat transfer fluid (HTF) can achieve temperatures above 700°C to improve power cycle performance for reducing large infrastructure costs of high-temperature systems. Current concentrating solar power (CSP) sensible HTF’s (e.g. air, salts) have poor thermal conductivity, and thus low heat transfer capabilities, requiring a large receiver. The high thermal conductivity of sodium has demonstrated high heat transfer rates on dish and towers systems, which allow a reduction in receiver area by a factor of two to four, reducing re-radiation and convection losses and cost by a similar factor. Sodium produces saturated vapor at pressures suitable for transportmore » starting at 600°C and reaches one atmosphere at 870°C, providing a wide range of suitable latent operating conditions that match proposed high temperature, isothermal input power cycles. This advantage could increase the receiver and system efficiency while lowering the cost of CSP tower systems. Although there are a number of desirable thermal performance advantages associated with sodium, its propensity to rapidly oxidize presents safety challenges. This investigation presents a literature review that captures historical operations/handling lessons for advanced sodium systems, and the current state-of-knowledge related to sodium combustion behavior. Technical and operational solutions addressing sodium safety and applications in CSP will be discussed, including unique safety hazards and advantages using latent sodium. Operation and maintenance experience from the nuclear industry with sensible and latent systems will also be discussed in the context of safety challenges and risk mitigation solutions.« less

Phenomenological studies on sodium for CSP applications: A safety review

NASA Astrophysics Data System (ADS)

Armijo, Kenneth M.; Andraka, Charles E.

2016-05-01

Sodium Heat transfer fluids (HTF) such as sodium, can achieve temperatures above 700°C to obtain power cycle performance improvements for reducing large infrastructure costs of high-temperature systems. Current concentrating solar power (CSP) sensible HTF's (e.g. air, salts) have poor thermal conductivity, and thus low heat transfer capabilities, requiring a large receiver. The high thermal conductivity of sodium has demonstrated high heat transfer rates on dish and towers systems, which allow a reduction in receiver area by a factor of two to four, reducing re-radiation and convection losses and cost by a similar factor. Sodium produces saturated vapor at pressures suitable for transport starting at 600°C and reaches one atmosphere at 870°C, providing a wide range of suitable operating conditions that match proposed high temperature, isothermal power cycles. This advantage could increase the efficiency while lowering the cost of CSP tower systems. Although there are a number of desirable thermal performance advantages associated with sensible sodium, its propensity to rapidly oxidize presents safety challenges. This investigation presents a literature review that captures historical operations/handling lessons for advanced sodium receiver designs, and the current state-of-knowledge related to sodium combustion behavior. Technical and operational solutions addressing sodium safety and applications in CSP will be discussed, including unique safety hazards and advantages using latent sodium. Lessons obtained from the nuclear industry with sensible and latent systems will also be discussed in the context of safety challenges and risk mitigation solutions.

Teamwork and patient safety in dynamic domains of healthcare: a review of the literature.

PubMed

Manser, T

2009-02-01

This review examines current research on teamwork in highly dynamic domains of healthcare such as operating rooms, intensive care, emergency medicine, or trauma and resuscitation teams with a focus on aspects relevant to the quality and safety of patient care. Evidence from three main areas of research supports the relationship between teamwork and patient safety: (1) Studies investigating the factors contributing to critical incidents and adverse events have shown that teamwork plays an important role in the causation and prevention of adverse events. (2) Research focusing on healthcare providers' perceptions of teamwork demonstrated that (a) staff's perceptions of teamwork and attitudes toward safety-relevant team behavior were related to the quality and safety of patient care and (b) perceptions of teamwork and leadership style are associated with staff well-being, which may impact clinician' ability to provide safe patient care. (3) Observational studies on teamwork behaviors related to high clinical performance have identified patterns of communication, coordination, and leadership that support effective teamwork. In recent years, research using diverse methodological approaches has led to significant progress in team research in healthcare. The challenge for future research is to further develop and validate instruments for team performance assessment and to develop sound theoretical models of team performance in dynamic medical domains integrating evidence from all three areas of team research identified in this review. This will help to improve team training efforts and aid the design of clinical work systems supporting effective teamwork and safe patient care.

INTEGRATION OF SYSTEMS ENGINEERING AND PROCESS INTENSIFICATION IN THE DESIGN OF PROCESSES FOR UTILIZING BIOBASED GLYCEROL

EPA Science Inventory

The expected results include an integrated process and mechanical design including a fabrication plan for the glycerol dehydration reactor, comprehensive heat and material balance, environmental impact assessment and comprehensive safety review. The resulting process design w...

Configuration and Data Management Process and the System Safety Professional

NASA Technical Reports Server (NTRS)

Shivers, Charles Herbert; Parker, Nelson C. (Technical Monitor)

2001-01-01

This article presents a discussion of the configuration management (CM) and the Data Management (DM) functions and provides a perspective of the importance of configuration and data management processes to the success of system safety activities. The article addresses the basic requirements of configuration and data management generally based on NASA configuration and data management policies and practices, although the concepts are likely to represent processes of any public or private organization's well-designed configuration and data management program.

Principles and Benefits of Explicitly Designed Medical Device Safety Architecture.

PubMed

Larson, Brian R; Jones, Paul; Zhang, Yi; Hatcliff, John

The complexity of medical devices and the processes by which they are developed pose considerable challenges to producing safe designs and regulatory submissions that are amenable to effective reviews. Designing an appropriate and clearly documented architecture can be an important step in addressing this complexity. Best practices in medical device design embrace the notion of a safety architecture organized around distinct operation and safety requirements. By explicitly separating many safety-related monitoring and mitigation functions from operational functionality, the aspects of a device most critical to safety can be localized into a smaller and simpler safety subsystem, thereby enabling easier verification and more effective reviews of claims that causes of hazardous situations are detected and handled properly. This article defines medical device safety architecture, describes its purpose and philosophy, and provides an example. Although many of the presented concepts may be familiar to those with experience in realization of safety-critical systems, this article aims to distill the essence of the approach and provide practical guidance that can potentially improve the quality of device designs and regulatory submissions.

[Fast Detection of Camellia Sinensis Growth Process and Tea Quality Informations with Spectral Technology: A Review].

PubMed

Peng, Ji-yu; Song, Xing-lin; Liu, Fei; Bao, Yi-dan; He, Yong

2016-03-01

The research achievements and trends of spectral technology in fast detection of Camellia sinensis growth process information and tea quality information were being reviewed. Spectral technology is a kind of fast, nondestructive, efficient detection technology, which mainly contains infrared spectroscopy, fluorescence spectroscopy, Raman spectroscopy and mass spectroscopy. The rapid detection of Camellia sinensis growth process information and tea quality is helpful to realize the informatization and automation of tea production and ensure the tea quality and safety. This paper provides a review on its applications containing the detection of tea (Camellia sinensis) growing status(nitrogen, chlorophyll, diseases and insect pest), the discrimination of tea varieties, the grade discrimination of tea, the detection of tea internal quality (catechins, total polyphenols, caffeine, amino acid, pesticide residual and so on), the quality evaluation of tea beverage and tea by-product, the machinery of tea quality determination and discrimination. This paper briefly introduces the trends of the technology of the determination of tea growth process information, sensor and industrial application. In conclusion, spectral technology showed high potential to detect Camellia sinensis growth process information, to predict tea internal quality and to classify tea varieties and grades. Suitable chemometrics and preprocessing methods is helpful to improve the performance of the model and get rid of redundancy, which provides the possibility to develop the portable machinery. Future work is to develop the portable machinery and on-line detection system is recommended to improve the further application. The application and research achievement of spectral technology concerning about tea were outlined in this paper for the first time, which contained Camellia sinensis growth, tea production, the quality and safety of tea and by-produce and so on, as well as some problems to be solved

Statin Therapy: Review of Safety and Potential Side Effects.

PubMed

Ramkumar, Satish; Raghunath, Ajay; Raghunath, Sudhakshini

2016-11-01

Hydroxymethyl glutaryl coenzyme A reductase inhibitors, commonly called statins, are some of the most commonly prescribed medications worldwide. Evidence suggests that statin therapy has significant mortality and morbidity benefit for both primary and secondary prevention from cardiovascular disease. Nonetheless, concern has been expressed regarding the adverse effects of long term statin use. The purpose of this article was to review the current medical literature regarding the safety of statins. Major trials and review articles on the safety of statins were identified in a search of the MEDLINE database from 1980 to 2016, which was limited to English articles. Myalgia is the most common side effect of statin use, with documented rates from 1-10%. Rhabdomyolysis is the most serious adverse effect from statin use, though it occurs quite rarely (less than 0.1%). The most common risk factors for statin-related myopathy include hypothyroidism, polypharmacy and alcohol abuse. Derangement in liver function tests is common, affecting up to 1% of patients; however, the clinical significance of this is unknown. Some statin drugs are potentially diabetogenic and the risk appears to increase in those patients on higher doses. Pitavastatin has not been associated with increased risk of diabetes. Statins have not been proven to increase the risk of malignancy, dementia, mood disorders or acute interstitial nephritis. However, statins do have multiple drug interactions, primarily those which interact with the cytochrome p450 enzyme group. Overall, statin drugs appear to be safe for use in the vast majority of patients. However, patients with multiple medical co-morbidities are at increased risk of adverse effects from long-term statin use.

The relationship between patient safety climate and standard precaution adherence: a systematic review of the literature

PubMed Central

Hessels, Amanda; Larson, Elaine

2015-01-01

SUMMARY Standard precaution (SP) adherence is universally suboptimal, despite being a core component of healthcare-associated infection (HCAI) prevention and healthcare worker (HCW) safety. Emerging evidence suggests that patient safety climate (PSC) factors may improve HCW behaviours. Our aim was to examine the relationship between PSC and SP adherence by HCWs in acute care hospitals. A systematic review was conducted as guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis. Three electronic databases were comprehensively searched for literature published or available in English between 2000 and 2014. Seven of 888 articles identified were eligible for final inclusion in the review. Two reviewers independently assessed study quality using a validated quality tool. The seven articles were assigned quality scores ranging from 7 to 10 of 10 possible points. Five measured all aspects of SP and two solely measured needlestick and sharps handling. Three included a secondary outcome of HCW exposure; none included HCAIs. All reported a statistically significant relationship between better PSC and greater SP adherence and used data from self-report surveys including validated PSC measures or measures of management support and leadership. Although limited in number, studies were of high quality and confirmed that PSC and SP adherence were correlated, suggesting that efforts to improve PSC may enhance adherence to a core component of HCAI prevention and HCW safety. More clearly evident is the need for additional high-quality research. PMID:26549480

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.

A primer on safety performance measures for the transportation planning process

DOT National Transportation Integrated Search

2009-09-01

This Primer is a tool to help State and local practitioners, transportation planners, and decision-makers identify, select, and use safety performance measures as a part of the transportation planning process. The Primer draws from current literature...

Applying the Extended Parallel Process Model to workplace safety messages.

PubMed

Basil, Michael; Basil, Debra; Deshpande, Sameer; Lavack, Anne M

2013-01-01

The extended parallel process model (EPPM) proposes fear appeals are most effective when they combine threat and efficacy. Three studies conducted in the workplace safety context examine the use of various EPPM factors and their effects, especially multiplicative effects. Study 1 was a content analysis examining the use of EPPM factors in actual workplace safety messages. Study 2 experimentally tested these messages with 212 construction trainees. Study 3 replicated this experiment with 1,802 men across four English-speaking countries-Australia, Canada, the United Kingdom, and the United States. The results of these three studies (1) demonstrate the inconsistent use of EPPM components in real-world work safety communications, (2) support the necessity of self-efficacy for the effective use of threat, (3) show a multiplicative effect where communication effectiveness is maximized when all model components are present (severity, susceptibility, and efficacy), and (4) validate these findings with gory appeals across four English-speaking countries.

Review of the OSHA-NIOSH Response to the Deepwater Horizon Oil Spill: Protecting the Health and Safety of Cleanup Workers.

PubMed

Michaels, David; Howard, John

2012-07-18

The fire and explosion of the Deepwater Horizon oil rig resulted in an enormous oil spill that threatened large distances of coastline. The overall response was led by the United States Coast Guard and involved the oil company BP, federal agencies, and state and local governments of five states. The Occupational Safety and Health Administration and the National Institute for Occupational Safety and Health focused extensive resources on ensuring that BP and its contractors provided safe working conditions for thousands of workers involved in the response. Federal personnel visited worksites daily, identifying hazards and means of abatement; assessed training programs to ensure that workers were adequately trained in languages they could understand; monitored chemical exposures and determined that the proper personal protective equipment was deployed; insisted on implementation of a heat mitigation program; rostered thousands of workers; and conducted extensive outreach in communities impacted by the spill. Advance planning, immediate deployment, and collaboration across agencies helped ensure that the response operations resulted in no worker fatalities, and relatively few injuries and illnesses. For future responses, improvements should be made in how safety and health information, as well as the process behind safety and health decisions, are communicated to the public. Michaels D, Howard J. Review of the OSHA-NIOSH Response to the Deepwater Horizon Oil Spill: Protecting the Health and Safety of Cleanup Workers. PLoS Currents Disasters. 2012 Jul 18.

Whole blood pathogen reduction technology and blood safety in sub-Saharan Africa: A systematic review with regional discussion

PubMed Central

Agbor, Gabriel; Asongalem, Emmanuel; Tagny, Claude; Asonganyi, Tazoacha

2016-01-01

Background Despite vast improvements in transfusion services in sub-Saharan Africa over the last decade, there remain serious concerns on the safety and adequacy of the blood supply across the region. Objective This review paper ascertains the role of pathogen reduction technology (PRT) in improving blood safety and supply adequacy in the region. Method The state of blood safety in sub-Saharan Africa was reviewed. Meetings, seminars and correspondence were undertaken with key clinicians, scientists and professional bodies in the region, including the World Health Organization’s Regional Office for Africa, to examine the suitability of PRT for improving the safety of whole blood transfusion, a prevalent transfusion format in the region. Results Existing literature suggests that combining PRT with current blood safety measures (such as serology) would improve the safety and adequacy of the blood supply for transfusions in sub-Saharan Africa. This was echoed by the findings of the stakeholder meetings. Conclusion Following a detailed appraisal of two leading PRT systems, the Mirasol® PRT System and the Cerus S-303 System, we suggest that companies conduct comprehensive toxicological evaluation of the agents used for PRT and publish this in the scientific literature. We also recommend that the safety and efficacy of these technologies should be established in a randomised clinical trial conducted in sub-Saharan Africa. PMID:28879109

Safety of regular formoterol or salmeterol in children with asthma: an overview of Cochrane reviews

PubMed Central

Cates, Christopher J; Oleszczuk, Marta; Stovold, Elizabeth; Wieland, L. Susan

2014-01-01

Background Two large surveillance studies in adults with asthma have found an increased risk of asthma-related mortality in those who took regular salmeterol as monotherapy in comparison to placebo or regular salbutamol. No similar sized surveillance studies have been carried out in children with asthma, and we remain uncertain about the comparative safety of regular combination therapy with either formoterol or salmeterol in children with asthma. Objectives We have used the paediatric trial results from Cochrane systematic reviews to assess the safety of regular formoterol or salmeterol, either as monotherapy or as combination therapy, in children with asthma. Methods We included Cochrane reviews relating to the safety of regular formoterol and salmeterol from a search of the Cochrane Database of Systematic Reviews conducted in May 2012, and ran updated searches for each of the reviews. These were independently assessed. All the reviews were assessed for quality using the AMSTAR tool. We extracted the data relating to children from each review and from new trials found in the updated searches (including risks of bias, study characteristics, serious adverse event outcomes, and control arm event rates). The safety of regular formoterol and salmeterol were assessed directly from the paediatric trials in the Cochrane reviews of monotherapy and combination therapy with each product. Then monotherapy was indirectly compared to combination therapy by looking at the differences between the pooled trial results for monotherapy and the pooled results for combination therapy. The comparative safety of formoterol and salmeterol was assessed using direct evidence from trials that randomised children to each treatment; this was combined with the result of an indirect comparison of the combination therapy trials, which represents the difference between the pooled results of each product when randomised against inhaled corticosteroids alone. Main results We identified six high

Safety of tumescent and laser-assisted liposuction: review of the literature.

PubMed

Tierney, Emily P; Kouba, David J; Hanke, C William

2011-12-01

Tumescent liposuction (TL) allows the removal of large volumes of fat with minimal blood loss or postoperative morbidity, excellent cosmesis, and a remarkable safety profile. To review the literature on the safety of tumescent liposuction, liposuction under general anesthesia and laser-assisted liposuction. Aggregate safety data on liposuction under tumescent anesthesia reveals over 100,000 body areas treated with liposuction. There were no serious complications of death, emboli, hypovolemic shock, perforation of thorax or peritoneum, thrombophlebitis, seizures, or toxic reactions to drugs. In contrast, in the plastic surgery literature, liposuction under general anesthesia was associated with complications of deep venous thrombosis or pulmonary embolus, abdominal or other organ perforation, infection, and bleeding. Most recently, survey data in the European literature analyzed data showed 72 cases of severe complications from liposuction, including 23 deaths in a 5-year period from 1998 to 2002. The most frequent complications were bacterial infections such as necrotizing fasciitis, gas gangrene, and different forms of sepsis. Further causes of lethal outcome were hemorrhages, perforation of abdominal viscera, and pulmonary embolism. Tumescent local anesthesia utilizing lidocaine with epinephrine allows the removal of large volumes of fat with minimal associated blood loss and postoperative morbidity.

Clinical intuition in the nursing process and decision-making-A mixed-studies review.

PubMed

Melin-Johansson, Christina; Palmqvist, Rebecca; Rönnberg, Linda

2017-12-01

To review what is characteristic of registered nurses' intuition in clinical settings, in relationships and in the nursing process. Intuition is a controversial concept and nurses believe that there are difficulties in how they should explain their nursing actions or decisions based on intuition. Much of the evidence from the body of research indicates that nurses value their intuition in a variety of clinical settings. More information on how nurses integrate intuition as a core element in daily clinical work would contribute to an improved understanding on how they go about this. Intuition deserves a place in evidence-based activities, where intuition is an important component associated with the nursing process. An integrative review strengthened with a mixed-studies review. Literature searches were conducted in the databases CINAHL, PubMed and PsycINFO, and literature published 1985-2016 were included. The findings in the studies were analysed with content analysis, and the synthesis process entailed a reasoning between the authors. After a quality assessment, 16 studies were included. The analysis and synthesis resulted in three categories. The characteristics of intuition in the nurse's daily clinical activities include application, assertiveness and experiences; in the relationships with patients' intuition include unique connections, mental and bodily responses, and personal qualities; and in the nursing process include support and guidance, component and clues in decision-making, and validating decisions. Intuition is more than simply a "gut feeling," and it is a process based on knowledge and care experience and has a place beside research-based evidence. Nurses integrate both analysis and synthesis of intuition alongside objective data when making decisions. They should rely on their intuition and use this knowledge in clinical practice as a support in decision-making, which increases the quality and safety of patient care. We find that intuition plays a

Safety: Preventive Medicine.

ERIC Educational Resources Information Center

Kotula, John R.; Digenakis, Anthony

1985-01-01

Underscores the need for community colleges to practice safety within the institutions and to instruct students in workplace safety procedures and requirements. Reviews Occupational Safety and Health Act (OSHA) regulations and their impact on industry and education. Looks at the legal responsibilities of colleges for safety. (DMM)

Effectiveness of assistive technology in improving the safety of people with dementia: a systematic review and meta-analysis.