Quality and safety aspects in histopathology laboratory

PubMed Central

Adyanthaya, Soniya; Jose, Maji

2013-01-01

Histopathology is an art of analyzing and interpreting the shapes, sizes and architectural patterns of cells and tissues within a given specific clinical background and a science by which the image is placed in the context of knowledge of pathobiology, to arrive at an accurate diagnosis. To function effectively and safely, all the procedures and activities of histopathology laboratory should be evaluated and monitored accurately. In histopathology laboratory, the concept of quality control is applicable to pre-analytical, analytical and post-analytical activities. Ensuring safety of working personnel as well as environment is also highly important. Safety issues that may come up in a histopathology lab are primarily those related to potentially hazardous chemicals, biohazardous materials, accidents linked to the equipment and instrumentation employed and general risks from electrical and fire hazards. This article discusses quality management system which can ensure quality performance in histopathology laboratory. The hazards in pathology laboratories and practical safety measures aimed at controlling the dangers are also discussed with the objective of promoting safety consciousness and the practice of laboratory safety. PMID:24574660

[Establishment of Quality Control System of Nucleic Acid Detection for Ebola Virus in Sierra Leone-China Friendship Biological Safety Laboratory].

PubMed

Wang, Qin; Zhang, Yong; Nie, Kai; Wang, Huanyu; Du, Haijun; Song, Jingdong; Xiao, Kang; Lei, Wenwen; Guo, Jianqiang; Wei, Hejiang; Cai, Kun; Wang, Yanhai; Wu, Jiang; Gerald, Bangura; Kamara, Idrissa Laybohr; Liang, Mifang; Wu, Guizhen; Dong, Xiaoping

2016-03-01

The quality control process throughout the Ebola virus nucleic acid detection in Sierra Leone-China Friendship Biological Safety Laboratory (SLE-CHN Biosafety Lab) was described in detail, in order to comprehensively display the scientific, rigorous, accurate and efficient practice in detection of Ebola virus of first batch detection team in SLE-CHN Biosafety Lab. Firstly, the key points of laboratory quality control system was described, including the managements and organizing, quality control documents and information management, instrument, reagents and supplies, assessment, facilities design and space allocation, laboratory maintenance and biosecurity. Secondly, the application of quality control methods in the whole process of the Ebola virus detection, including before the test, during the test and after the test, was analyzed. The excellent and professional laboratory staffs, the implementation of humanized management are the cornerstone of the success; High-level biological safety protection is the premise for effective quality control and completion of Ebola virus detection tasks. And professional logistics is prerequisite for launching the laboratory diagnosis of Ebola virus. The establishment and running of SLE-CHN Biosafety Lab has landmark significance for the friendship between Sierra Leone and China, and the lab becomes the most important base for Ebola virus laboratory testing in Sierra Leone.

Obstetric Safety and Quality.

PubMed

Pettker, Christian M; Grobman, William A

2015-07-01

Obstetric safety and quality is an emerging and important topic not only as a result of the pressures of patient and regulatory expectations, but also because of the genuine interest of caregivers to reduce harm, improve outcomes, and optimize care. Although each seeks to improve care by using scientific approaches beyond human physiology and pathophysiology, patient safety methodologies seek to avoid preventable adverse events, whereas health care quality projects aim to achieve the best possible outcomes. It is well-documented that an increasingly complex medical system controlled by human workers is a circumstance subject to recurrent failure. A safety culture encourages a proactive approach to mitigate failure before, during, and after it occurs. This article highlights the key concepts in health care safety and quality and reviews the background of the quality improvement sciences with particular emphasis on obstetric outcomes and quality measures.

Evaluating the Effectiveness of Two Teaching Strategies to Improve Nursing Students' Knowledge, Skills, and Attitudes About Quality Improvement and Patient Safety.

PubMed

Maxwell, Karen L; Wright, Vivian H

The purpose of this study was to evaluate two teaching strategies with regard to quality and safety education for nurses content on quality improvement and safety. Two groups (total of 64 students) participated in online learning or online learning in conjunction with a flipped classroom. A pretest/posttest control group design was used. The use of online modules in conjunction with the flipped classroom had a greater effect on increasing nursing students' knowledge of quality improvement than the use of online modules only. There was no statistically significant difference between the groups for safety.

[Update on microbiological quality assurance meat and meat products in Morocco].

PubMed

Rachidi, H; Latrache, H

2018-03-01

Food safety has become an absolute necessity in all countries. As a result, Morocco has taken several measures and actions to develop food safety and food-borne disease control. This study aimed to highlight the level of improvement in the quality assurance of meat and meat products in Morocco. It is based on a non-exhaustive review of the regulatory texts governing food safety in the country, as well as a statistical study on establishments of meat and meat products adopting a self-checking system and approved by the National Office of Sanitary Safety of Food. Morocco has introduced several laws and regulations requiring sanitary control of food products. Also, the number of establishments of meat and meat products adopting a system of self-control and approved by the National Office of Sanitary Safety of Food has improved significantly. It has increased from 58 in 2007 to 273 in 2016. The adoption of self-monitoring systems allows better access to international markets, improved quality of food products and a considerable reduction in microbial contamination. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

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.

[Preliminary studies on critical control point of traceability system in wolfberry].

PubMed

Liu, Sai; Xu, Chang-Qing; Li, Jian-Ling; Lin, Chen; Xu, Rong; Qiao, Hai-Li; Guo, Kun; Chen, Jun

2016-07-01

As a traditional Chinese medicine, wolfberry (Lycium barbarum) has a long cultivation history and a good industrial development foundation. With the development of wolfberry production, the expansion of cultivation area and the increased attention of governments and consumers on food safety, the quality and safety requirement of wolfberry is higher demanded. The quality tracing and traceability system of production entire processes is the important technology tools to protect the wolfberry safety, and to maintain sustained and healthy development of the wolfberry industry. Thus, this article analyzed the wolfberry quality management from the actual situation, the safety hazard sources were discussed according to the HACCP (hazard analysis and critical control point) and GAP (good agricultural practice for Chinese crude drugs), and to provide a reference for the traceability system of wolfberry. Copyright© by the Chinese Pharmaceutical Association.

Prevention and control of food safety risks: the role of governments, food producers, marketers, and academia.

PubMed

Lupien, John R

2007-01-01

Food systems are rapidly changing as world population grows, increasing urbanization occurs, consumer tastes and preferences change and differ in various countries and cultures, large scale food production increases, and food imports and exports grow in volume and value. Consumers in all countries have become more insistent that foods available in the marketplace are of good quality and safe, and do not pose risks to them and their families. Publicity about food risk problems and related risks, including chemical and microbiological contamination of foods, mad-cow disease, avian flu, industrial chemical contamination all have made consumers and policy makers more aware of the need of the control of food safety risk factors in all countries. To discuss changes in food systems, and in consumer expectations, that have placed additional stress on the need for better control of food safety risks. Food producers, processors, and marketers have additional food law and regulations to meet; government agencies must increase monitoring and enforcement of adequate food quality and safety legislation and coordinate efforts between agriculture, health, trade, justice and customs agencies; and academia must take action to strengthen the education of competent food legislation administrators, inspectorate, and laboratory personnel for work in government and industry, including related food and food safety research . Both Government and the food industry must assure that adequate control programs are in place to control the quality and safety of all foods, raw or processed, throughout the food chain from production to final consumption. This includes appropriate laboratory facilities to perform necessary analysis of foods for risk and quality factors, and to carry out a wide range of food science, toxicological and related research.

Layoffs and tradeoffs: production, quality, and safety demands under the threat of job loss.

PubMed

Probst, Tahira M

2002-07-01

Employees often face a conflict between production targets, quality assurance, and adherence to safety policies. In a time when layoffs are on the rise, it is important to understand the effects of employee job insecurity on these potentially competing demands. A laboratory experiment manipulated the threat of layoffs in a simulated organization and assessed its effect on employee productivity, product quality, and adherence to safety policies. Results suggest that student participants faced with the threat of layoffs were more productive, yet violated more safety rules and produced lower quality outputs, than participants in the control condition. Implications for organizations contemplating layoffs and directions for future research are discussed.

The complications of controlling agency time discretion: FDA review deadlines and postmarket drug safety.

PubMed

Carpenter, Daniel; Chattopadhyay, Jacqueline; Moffitt, Susan; Nall, Clayton

2012-01-01

Public agencies have discretion on the time domain, and politicians deploy numerous policy instruments to constrain it. Yet little is known about how administrative procedures that affect timing also affect the quality of agency decisions. We examine whether administrative deadlines shape decision timing and the observed quality of decisions. Using a unique and rich dataset of FDA drug approvals that allows us to examine decision timing and quality, we find that this administrative tool induces a piling of decisions before deadlines, and that these “just-before-deadline” approvals are linked with higher rates of postmarket safety problems (market withdrawals, severe safety warnings, safety alerts). Examination of data from FDA advisory committees suggests that the deadlines may impede quality by impairing late-stage deliberation and agency risk communication. Our results both support and challenge reigning theories about administrative procedures, suggesting they embody expected control-expertise trade-offs, but may also create unanticipated constituency losses.

Control of Suspect/Counterfeit and Defective Items

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

Sheriff, Marnelle L.

2013-09-03

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

Improving Elementary School Quality Through the Use of a Social-Emotional and Character Development Program: A Matched-Pair, Cluster-Randomized, Controlled Trial in Hawai’i

PubMed Central

Snyder, Frank J.; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac J.; Flay, Brian R.

2012-01-01

BACKGROUND School safety and quality affect student learning and success. This study examined the effects of a comprehensive elementary school-wide social-emotional and character education program, Positive Action, on teacher, parent, and student perceptions of school safety and quality utilizing a matched-pair, cluster-randomized, controlled design. The Positive Action Hawai’i trial included 20 racially/ethnically diverse schools and was conducted from 2002–2003 through 2005–2006. METHODS School-level archival data, collected by the Hawai’i Department of Education, were used to examine program effects at 1-year post-trial. Teacher, parent, and student data were analyzed to examine indicators of school quality such as student safety and well-being, involvement, and satisfaction, as well as overall school quality. Matched-paired t-tests were used for the primary analysis, and sensitivity analyses included permutation tests and random-intercept growth curve models. RESULTS Analyses comparing change from baseline to 1-year post-trial revealed that intervention schools demonstrated significantly improved school quality compared to control schools, with 21%, 13%, and 16% better overall school quality scores as reported by teachers, parents, and students, respectively. Teacher, parent, and student reports on individual school-quality indicators showed improvement in student safety and well-being, involvement, satisfaction, quality student support, focused and sustained action, standards-based learning, professionalism and system capacity, and coordinated team work. Teacher reports also showed an improvement in the responsiveness of the system. CONCLUSIONS School quality was substantially improved, providing evidence that a school-wide social-emotional and character education program can enhance school quality and facilitate whole-school change. PMID:22142170

Improving elementary school quality through the use of a social-emotional and character development program: a matched-pair, cluster-randomized, controlled trial in Hawai'i.

PubMed

Snyder, Frank J; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac J; Flay, Brian R

2012-01-01

School safety and quality affect student learning and success. This study examined the effects of a comprehensive elementary school-wide social-emotional and character education program, Positive Action, on teacher, parent, and student perceptions of school safety and quality utilizing a matched-pair, cluster-randomized, controlled design. The Positive Action Hawai'i trial included 20 racially/ethnically diverse schools and was conducted from 2002-2003 through 2005-2006. School-level archival data, collected by the Hawai'i Department of Education, were used to examine program effects at 1-year post-trial. Teacher, parent, and student data were analyzed to examine indicators of school quality such as student safety and well-being, involvement, and satisfaction, as well as overall school quality. Matched-paired t-tests were used for the primary analysis, and sensitivity analyses included permutation tests and random-intercept growth curve models. Analyses comparing change from baseline to 1-year post-trial revealed that intervention schools demonstrated significantly improved school quality compared to control schools, with 21%, 13%, and 16% better overall school quality scores as reported by teachers, parents, and students, respectively. Teacher, parent, and student reports on individual school-quality indicators showed improvement in student safety and well-being, involvement, satisfaction, quality student support, focused and sustained action, standards-based learning, professionalism and system capacity, and coordinated team work. Teacher reports also showed an improvement in the responsiveness of the system. School quality was substantially improved, providing evidence that a school-wide social-emotional and character education program can enhance school quality and facilitate whole-school change. © 2011, American School Health Association.

Assuring fish safety and quality in international fish trade.

PubMed

Ababouch, Lahsen

2006-01-01

International trade in fishery commodities reached US 58.2 billion dollars in 2002, a 5% improvement relative to 2000 and a 45% increase over 1992 levels. Within this global trade, developing countries registered a net trade surplus of US 17.4 billion dollars in 2002 and accounted for almost 50% by value and 55% of fish exports by volume. This globalization of fish trade, coupled with technological developments in food production, handling, processing and distribution, and the increasing awareness and demand of consumers for safe and high quality food have put food safety and quality assurance high in public awareness and a priority for many governments. Consequently, many countries have tightened food safety controls, imposing additional costs and requirements on imports. As early as 1980, there was an international drive towards adopting preventative HACCP-based safety and quality systems. More recently, there has been a growing awareness of the importance of an integrated, multidisciplinary approach to food safety and quality throughout the entire food chain. Implementation of this approach requires an enabling policy and regulatory environment at national and international levels with clearly defined rules and standards, establishment of appropriate food control systems and programmes at national and local levels, and provision of appropriate training and capacity building. This paper discusses the international framework for fish safety and quality, with particular emphasis on the United Nation's Food and Agricultural Organization's (FAO) strategy to promote international harmonization and capacity building.

Strategic Importance of the US Army Veterinary Service in an NBC Environment

DTIC Science & Technology

1999-04-01

all branches of the Department of Defense. That support includes food safety and quality assurance; zoonotic disease control and prevention; medical...environment as it relates to food safety and quality assurance. The focus of the paper is to examine the current threat from weapons of mass destruction

Recent Developments in Hyperspectral Imaging for Assessment of Food Quality and Safety

PubMed Central

Huang, Hui; Liu, Li; Ngadi, Michael O.

2014-01-01

Hyperspectral imaging which combines imaging and spectroscopic technology is rapidly gaining ground as a non-destructive, real-time detection tool for food quality and safety assessment. Hyperspectral imaging could be used to simultaneously obtain large amounts of spatial and spectral information on the objects being studied. This paper provides a comprehensive review on the recent development of hyperspectral imaging applications in food and food products. The potential and future work of hyperspectral imaging for food quality and safety control is also discussed. PMID:24759119

Improving Elementary School Quality through the Use of a Social-Emotional and Character Development Program: A Matched-Pair, Cluster-Randomized, Controlled Trial in Hawai'i

ERIC Educational Resources Information Center

Snyder, Frank J.; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac J.; Flay, Brian R.

2012-01-01

Background: School safety and quality affect student learning and success. This study examined the effects of a comprehensive elementary school-wide social-emotional and character education program, Positive Action, on teacher, parent, and student perceptions of school safety and quality utilizing a matched-pair, cluster-randomized, controlled…

Quality Attribute Techniques Framework

NASA Astrophysics Data System (ADS)

Chiam, Yin Kia; Zhu, Liming; Staples, Mark

The quality of software is achieved during its development. Development teams use various techniques to investigate, evaluate and control potential quality problems in their systems. These “Quality Attribute Techniques” target specific product qualities such as safety or security. This paper proposes a framework to capture important characteristics of these techniques. The framework is intended to support process tailoring, by facilitating the selection of techniques for inclusion into process models that target specific product qualities. We use risk management as a theory to accommodate techniques for many product qualities and lifecycle phases. Safety techniques have motivated the framework, and safety and performance techniques have been used to evaluate the framework. The evaluation demonstrates the ability of quality risk management to cover the development lifecycle and to accommodate two different product qualities. We identify advantages and limitations of the framework, and discuss future research on the framework.

Sampling the food processing environment: taking up the cudgel for preventive quality management in food processing environments.

PubMed

Wagner, Martin; Stessl, Beatrix

2014-01-01

The Listeria monitoring program for Austrian cheese factories was established in 1988. The basic idea is to control the introduction of L. monocytogenes into the food processing environment, preventing the pathogen from contaminating the food under processing. The Austrian Listeria monitoring program comprises four levels of investigation, dealing with routine monitoring of samples and consequences of finding a positive sample. Preventive quality control concepts attempt to detect a foodborne hazard along the food processing chain, prior to food delivery, retailing, and consumption. The implementation of a preventive food safety concept provokes a deepened insight by the manufacturers into problems concerning food safety. The development of preventive quality assurance strategies contributes to the national food safety status and protects public health.

The effect of chlorine dioxide and chitosan/essential oil coatings on the safety and quality of fresh blueberries

USDA-ARS?s Scientific Manuscript database

Blueberries are high-value fruit with strong antioxidant capacity and other health-promoting benefits. Controlled release chlorine dioxide (ClO2) or chitosan coating plus different essential oils were applied to fresh blueberries to preserve their quality and safety during postharvest storage. In vi...

Advanced Manufacturing Systems in Food Processing and Packaging Industry

NASA Astrophysics Data System (ADS)

Shafie Sani, Mohd; Aziz, Faieza Abdul

2013-06-01

In this paper, several advanced manufacturing systems in food processing and packaging industry are reviewed, including: biodegradable smart packaging and Nano composites, advanced automation control system consists of fieldbus technology, distributed control system and food safety inspection features. The main purpose of current technology in food processing and packaging industry is discussed due to major concern on efficiency of the plant process, productivity, quality, as well as safety. These application were chosen because they are robust, flexible, reconfigurable, preserve the quality of the food, and efficient.

The new Israeli feed safety law: challenges in relation to animal and public health.

PubMed

Barel, Shimon; Elad, Dani; Cuneah, Olga; Shimshoni, Jakob A

2017-03-01

The Israeli feed safety legislation, which came to prominence in the early 1970s, has undergone a major change from simple feed safety and quality regulations to a more holistic concept of control of feed safety and quality throughout the whole feed production chain, from farm to the end user table. In February 2014, a new law was approved by the Israeli parliament, namely the Control of Animal Feed Law, which is expected to enter into effect in 2017. The law is intended to regulate the production and marketing of animal feed, guaranteeing the safety and quality of animal products throughout the production chain. The responsibility on the implementation of the new feed law was moved from the Plant Protection Inspection Service to the Veterinary Services and Animal Health. In preparation for the law's implementation, we have characterized the various sources and production lines of feed for farm and domestic animals in Israel and assessed the current feed safety challenges in terms of potential hazards or undesirable substances. Moreover, the basic requirements for feed safety laboratories, which are mandatory for analyzing and testing for potential contaminants, are summarized for each of the contaminants discussed. © 2016 Society of Chemical Industry. © 2016 Society of Chemical Industry.

A Comprehensive Review of Spirit Drink Safety Standards and Regulations from an International Perspective.

PubMed

Pang, Xiao-Na; Li, Zhao-Jie; Chen, Jing-Yu; Gao, Li-Juan; Han, Bei-Zhong

2017-03-01

Standards and regulations related to spirit drinks have been established by different countries and international organizations to ensure the safety and quality of spirits. Here, we introduce the principles of food safety and quality standards for alcoholic beverages and then compare the key indicators used in the distinct standards of the Codex Alimentarius Commission, the European Union, the People's Republic of China, the United States, Canada, and Australia. We also discuss in detail the "maximum level" of the following main contaminants of spirit drinks: methanol, higher alcohols, ethyl carbamate, hydrocyanic acid, heavy metals, mycotoxins, phthalates, and aldehydes. Furthermore, the control measures used for potential hazards are introduced. Harmonization of the current requirements based on comprehensive scope analysis and the risk assessment approach will enhance both the trade and quality of distilled spirits. This review article provides valuable information that will enable producers, traders, governments, and researchers to increase their knowledge of spirit drink safety requirements, control measures, and research trends.

21 CFR 106.1 - Status and applicability of the quality control procedures regulation.

Code of Federal Regulations, 2011 CFR

2011-04-01

... AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES... infant formula meets the safety, quality, and nutrient requirements of section 412 of the act and the..., processing, and packaging of an infant formula shall render such formula adulterated under section 412(a)(1...

21 CFR 106.1 - Status and applicability of the quality control procedures regulation.

Code of Federal Regulations, 2010 CFR

2010-04-01

... AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES... infant formula meets the safety, quality, and nutrient requirements of section 412 of the act and the..., processing, and packaging of an infant formula shall render such formula adulterated under section 412(a)(1...

Consumer Choice between Food Safety and Food Quality: The Case of Farm-Raised Atlantic Salmon

PubMed Central

Haghiri, Morteza

2016-01-01

Since the food incidence of polychlorinated biphenyls in farm-raised Atlantic salmon, its market demand has drastically changed as a result of consumers mistrust in both the quality and safety of the product. Policymakers have been trying to find ways to ensure consumers that farm-raised Atlantic salmon is safe. One of the suggested policies is the implementation of integrated traceability methods and quality control systems. This article examines consumer choice between food safety and food quality to purchase certified farm-raised Atlantic salmon, defined as a product that has passed through various stages of traceability systems in the province of Newfoundland and Labrador, Canada. PMID:28231118

Watershed safety and quality control by safety threshold method

NASA Astrophysics Data System (ADS)

Da-Wei Tsai, David; Mengjung Chou, Caroline; Ramaraj, Rameshprabu; Liu, Wen-Cheng; Honglay Chen, Paris

2014-05-01

Taiwan was warned as one of the most dangerous countries by IPCC and the World Bank. In such an exceptional and perilous island, we would like to launch the strategic research of land-use management on the catastrophe prevention and environmental protection. This study used the watershed management by "Safety Threshold Method" to restore and to prevent the disasters and pollution on island. For the deluge prevention, this study applied the restoration strategy to reduce total runoff which was equilibrium to 59.4% of the infiltration each year. For the sediment management, safety threshold management could reduce the sediment below the equilibrium of the natural sediment cycle. In the water quality issues, the best strategies exhibited the significant total load reductions of 10% in carbon (BOD5), 15% in nitrogen (nitrate) and 9% in phosphorus (TP). We found out the water quality could meet the BOD target by the 50% peak reduction with management. All the simulations demonstrated the safety threshold method was helpful to control the loadings within the safe range of disasters and environmental quality. Moreover, from the historical data of whole island, the past deforestation policy and the mistake economic projects were the prime culprits. Consequently, this study showed a practical method to manage both the disasters and pollution in a watershed scale by the land-use management.

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

PubMed Central

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

2014-01-01

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

Modeling for influenza vaccines and adjuvants profile for safety prediction system using gene expression profiling and statistical tools

PubMed Central

Sasaki, Eita; Momose, Haruka; Hiradate, Yuki; Furuhata, Keiko; Takai, Mamiko; Asanuma, Hideki; Ishii, Ken J.

2018-01-01

Historically, vaccine safety assessments have been conducted by animal testing (e.g., quality control tests and adjuvant development). However, classical evaluation methods do not provide sufficient information to make treatment decisions. We previously identified biomarker genes as novel safety markers. Here, we developed a practical safety assessment system used to evaluate the intramuscular, intraperitoneal, and nasal inoculation routes to provide robust and comprehensive safety data. Influenza vaccines were used as model vaccines. A toxicity reference vaccine (RE) and poly I:C-adjuvanted hemagglutinin split vaccine were used as toxicity controls, while a non-adjuvanted hemagglutinin split vaccine and AddaVax (squalene-based oil-in-water nano-emulsion with a formulation similar to MF59)-adjuvanted hemagglutinin split vaccine were used as safety controls. Body weight changes, number of white blood cells, and lung biomarker gene expression profiles were determined in mice. In addition, vaccines were inoculated into mice by three different administration routes. Logistic regression analyses were carried out to determine the expression changes of each biomarker. The results showed that the regression equations clearly classified each vaccine according to its toxic potential and inoculation amount by biomarker expression levels. Interestingly, lung biomarker expression was nearly equivalent for the various inoculation routes. The results of the present safety evaluation were confirmed by the approximation rate for the toxicity control. This method may contribute to toxicity evaluation such as quality control tests and adjuvant development. PMID:29408882

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

PubMed

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

2012-08-01

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

Expanding the scope of practice for radiology managers: radiation safety duties.

PubMed

Orders, Amy B; Wright, Donna

2003-01-01

In addition to financial responsibilities and patient care duties, many medical facilities also expect radiology department managers to wear "safety" hats and complete fundamental quality control/quality assurance, conduct routine safety surveillance in the department, and to meet regulatory demands in the workplace. All managers influence continuous quality improvement initiatives, from effective utilization of resource and staffing allocations, to efficacy of patient scheduling tactics. It is critically important to understand continuous quality improvement (CQI) and its relationship with the radiology manager, specifically quality assurance/quality control in routine work, as these are the fundamentals of institutional safety, including radiation safety. When an institution applies for a registration for radiation-producing devices or a license for the use of radioactive materials, the permit granting body has specific requirements, policies and procedures that must be satisfied in order to be granted a permit and to maintain it continuously. In the 32 U.S. Agreement states, which are states that have radiation safety programs equivalent to the Nuclear Regulatory Commission programs, individual facilities apply for permits through the local governing body of radiation protection. Other states are directly licensed by the Nuclear Regulatory Commission and associated regulatory entities. These regulatory agencies grant permits, set conditions for use in accordance with state and federal laws, monitor and enforce radiation safety activities, and audit facilities for compliance with their regulations. Every radiology department and associated areas of radiation use are subject to inspection and enforcement policies in order to ensure safety of equipment and personnel. In today's business practice, department managers or chief technologists may actively participate in the duties associated with institutional radiation safety, especially in smaller institutions, while other facilities may assign the duties and title of "radiation safety officer" to a radiologist or other management, per the requirements of regulatory agencies in that state. Radiation safety in a medical setting can be delineated into two main categories--equipment and personnel requirements--each having very specific guidelines. The literature fails to adequately address the blatant link between radiology department managers and radiation safety duties. The breadth and depth of this relationship is of utmost concern and warrants deeper insight as the demands of the regulatory agencies increase with the new advances in technology, procedures and treatments associated with radiation-producing devices and radioactive materials.

Data protection and the patient's right to safety.

PubMed

Herveg, Jean

2014-06-01

The article investigates the issue of knowing whether or not the proposal for a general data protection regulation could improve the patient's safety. This has been analyzed through the four main contributions that should be expected at least from data protection to the patient's safety. In our view, data protection should help supporting efficient information systems in healthcare, increasing data quality, strengthening the patient's rights and drawing the legal framework for performing quality control procedures. Compared to the current legal framework, it is not sure that the proposal might improve any of these contributions to the patient's safety.

48 CFR 252.209-7010 - Critical Safety Items.

Code of Federal Regulations, 2014 CFR

2014-10-01

... personal injury or loss of life; or (iii) An uncommanded engine shutdown that jeopardizes safety. Design... personal injury or loss of life. (b) Identification of critical safety items. One or more of the items... control activity: (Insert additional lines as necessary) (c) Heightened quality assurance surveillance...

48 CFR 252.209-7010 - Critical Safety Items.

Code of Federal Regulations, 2013 CFR

2013-10-01

... personal injury or loss of life; or (iii) An uncommanded engine shutdown that jeopardizes safety. Design... personal injury or loss of life. (b) Identification of critical safety items. One or more of the items... control activity: (Insert additional lines as necessary) (c) Heightened quality assurance surveillance...

48 CFR 252.209-7010 - Critical Safety Items.

Code of Federal Regulations, 2012 CFR

2012-10-01

... personal injury or loss of life; or (iii) An uncommanded engine shutdown that jeopardizes safety. Design... personal injury or loss of life. (b) Identification of critical safety items. One or more of the items... control activity: (Insert additional lines as necessary) (c) Heightened quality assurance surveillance...

48 CFR 252.209-7010 - Critical Safety Items.

Code of Federal Regulations, 2011 CFR

2011-10-01

... personal injury or loss of life; or (iii) An uncommanded engine shutdown that jeopardizes safety. Design... personal injury or loss of life. (b) Identification of critical safety items. One or more of the items... control activity: (Insert additional lines as necessary) (c) Heightened quality assurance surveillance...

SUPERFUND TREATABILITY CLEARINGHOUSE: SOIL STABILIZATION PILOT STUDY, UNITED CHROME NPL SITE PILOT STUDY AND HEALTH AND SAFETY PROGRAM, UNITED CHROME NPL SITE PILOT STUDY

EPA Science Inventory

This document is a project plan for a pilot study at the United Chrome NPL site, Corvallis, Oregon and includes the health and safety and quality assurance/quality control plans. The plan reports results of a bench-scale study of the treatment process as iieasured by the ...

21 CFR 107.50 - Terms and conditions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Center for Food Safety and Applied Nutrition concludes that additional or modified quality control... also typically represented and labeled for use to provide dietary management for diseases or conditions... regulations promulgated under section 412(a)(2) of the act, the quality control procedure requirements of part...

Assessment of Primary Production of Horticultural Safety Management Systems of Mushroom Farms in South Africa.

PubMed

Dzingirayi, Garikayi; Korsten, Lise

2016-07-01

Growing global consumer concern over food safety in the fresh produce industry requires producers to implement necessary quality assurance systems. Varying effectiveness has been noted in how countries and food companies interpret and implement food safety standards. A diagnostic instrument (DI) for global fresh produce industries was developed to measure the compliancy of companies with implemented food safety standards. The DI is made up of indicators and descriptive grids for context factors and control and assurance activities to measure food safety output. The instrument can be used in primary production to assess food safety performance. This study applied the DI to measure food safety standard compliancy of mushroom farming in South Africa. Ten farms representing almost half of the industry farms and more than 80% of production were independently assessed for their horticultural safety management system (HSMS) compliance via in-depth interviews with each farm's quality assurance personnel. The data were processed using Microsoft Office Excel 2010 and are represented in frequency tables. The diagnosis revealed that the mushroom farming industry had an average food safety output. The farms were implementing an average-toadvanced HSMS and operating in a medium-risk context. Insufficient performance areas in HSMSs included inadequate hazard analysis and analysis of control points, low specificity of pesticide assessment, and inadequate control of suppliers and incoming materials. Recommendations to the industry and current shortcomings are suggested for realization of an improved industry-wide food safety assurance system.

Medical Devices; Immunology and Microbiology Devices; Classification of the Assayed Quality Control Material for Clinical Microbiology Assays. Final order.

PubMed

2017-07-27

The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.

Verification and Implementation of Operations Safety Controls for Flight Missions

NASA Technical Reports Server (NTRS)

Smalls, James R.; Jones, Cheryl L.; Carrier, Alicia S.

2010-01-01

There are several engineering disciplines, such as reliability, supportability, quality assurance, human factors, risk management, safety, etc. Safety is an extremely important engineering specialty within NASA, and the consequence involving a loss of crew is considered a catastrophic event. Safety is not difficult to achieve when properly integrated at the beginning of each space systems project/start of mission planning. The key is to ensure proper handling of safety verification throughout each flight/mission phase. Today, Safety and Mission Assurance (S&MA) operations engineers continue to conduct these flight product reviews across all open flight products. As such, these reviews help ensure that each mission is accomplished with safety requirements along with controls heavily embedded in applicable flight products. Most importantly, the S&MA operations engineers are required to look for important design and operations controls so that safety is strictly adhered to as well as reflected in the final flight product.

40 CFR 455.21 - Specialized definitions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... pollution control blowdown, steam jet blowdown, vacuum pump water, pump seal water, safety equipment.../process laboratory quality control wastewater. Notwithstanding any other regulation, process wastewater...

40 CFR 455.21 - Specialized definitions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... pollution control blowdown, steam jet blowdown, vacuum pump water, pump seal water, safety equipment.../process laboratory quality control wastewater. Notwithstanding any other regulation, process wastewater...

40 CFR 455.21 - Specialized definitions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... pollution control blowdown, steam jet blowdown, vacuum pump water, pump seal water, safety equipment.../process laboratory quality control wastewater. Notwithstanding any other regulation, process wastewater...

Mindfulness Meditation for Chronic Pain: Systematic Review and Meta-analysis.

PubMed

Hilton, Lara; Hempel, Susanne; Ewing, Brett A; Apaydin, Eric; Xenakis, Lea; Newberry, Sydne; Colaiaco, Ben; Maher, Alicia Ruelaz; Shanman, Roberta M; Sorbero, Melony E; Maglione, Margaret A

2017-04-01

Chronic pain patients increasingly seek treatment through mindfulness meditation. This study aims to synthesize evidence on efficacy and safety of mindfulness meditation interventions for the treatment of chronic pain in adults. We conducted a systematic review on randomized controlled trials (RCTs) with meta-analyses using the Hartung-Knapp-Sidik-Jonkman method for random-effects models. Quality of evidence was assessed using the GRADE approach. Outcomes included pain, depression, quality of life, and analgesic use. Thirty-eight RCTs met inclusion criteria; seven reported on safety. We found low-quality evidence that mindfulness meditation is associated with a small decrease in pain compared with all types of controls in 30 RCTs. Statistically significant effects were also found for depression symptoms and quality of life. While mindfulness meditation improves pain and depression symptoms and quality of life, additional well-designed, rigorous, and large-scale RCTs are needed to decisively provide estimates of the efficacy of mindfulness meditation for chronic pain.

[Recommendations for inspections of the French nuclear safety authority].

PubMed

Rousse, C; Chauvet, B

2015-10-01

The French nuclear safety authority is responsible for the control of radiation protection in radiotherapy since 2002. Controls are based on the public health and the labour codes and on the procedures defined by the controlled health care facility for its quality and safety management system according to ASN decision No. 2008-DC-0103. Inspectors verify the adequacy of the quality and safety management procedures and their implementation, and select process steps on the basis of feedback from events notified to ASN. Topics of the inspection are communicated to the facility at the launch of a campaign, which enables them to anticipate the inspectors' expectations. In cases where they are not physicians, inspectors are not allowed to access information covered by medical confidentiality. The consulted documents must therefore be expunged of any patient-identifying information. Exchanges before the inspection are intended to facilitate the provision of documents that may be consulted. Finally, exchange slots between inspectors and the local professionals must be organized. Based on improvements achieved by the health care centres and on recommendations from a joint working group of radiotherapy professionals and the nuclear safety authority, changes will be made in the control procedure that will be implemented when developing the inspection program for 2016-2019. Copyright © 2015. Published by Elsevier SAS.

[Quality control in anesthesiology].

PubMed

Muñoz-Ramón, J M

1995-03-01

The process of quality control and auditing of anesthesiology allows us to evaluate care given by a service and solve problems that are detected. Quality control is a basic element of care giving and is only secondarily an area of academic research; it is therefore a meaningless effort if the information does not serve to improve departmental procedures. Quality assurance procedures assume certain infrastructural requirements and an initial period of implementation and adjustment. The main objectives of quality control are the reduction of morbidity and mortality due to anesthesia, assurance of the availability and proper management of resources and, finally, the well-being and safety of the patient.

A Comparative Study of Natural Antimicrobial Delivery Systems for Microbial Safety and Quality of Fresh-Cut Lettuce.

PubMed

Hill, Laura E; Oliveira, Daniela A; Hills, Katherine; Giacobassi, Cassie; Johnson, Jecori; Summerlin, Harvey; Taylor, T Matthew; Gomes, Carmen L

2017-05-01

Nanoencapsulation can provide a means to effectively deliver antimicrobial compounds and enhance the safety of fresh produce. However, to date there are no studies which directly compares how different nanoencapsulation systems affect fresh produce safety and quality. This study compared the effects on quality and safety of fresh-cut lettuce treated with free and nanoencapsulated natural antimicrobial, cinnamon bark extract (CBE). A challenge study compared antimicrobial efficacy of 3 different nanoencapsulated CBE systems. The most effective antimicrobial treatment against Listeria monocytogenes was chitosan-co-poly-N-isopropylacrylamide (chitosan-PNIPAAM) encapsulated CBE, with a reduction on bacterial load up to 2 log 10 CFU/g (P < 0.05) compared to the other encapsulation systems when fresh-cut lettuce was stored at 5 °C and 10 °C for 15 d. Subsequently, chitosan-PNIPAAM-CBE nanoparticles (20, 40, and 80 mg/mL) were compared to a control and free CBE (400, 800, and 1600 μg/mL) for its effects on fresh-cut lettuce quality over 15 d at 5 °C. By the 10th day, the most effective antimicrobial concentration was 80 mg/mL for chitosan-PNIPAAM-CBE, up to 2 log 10 CFU/g reduction (P < 0.05), compared with the other treatments. There was no significant difference between control and treated samples up to day 10 for the quality attributes evaluated. Chitosan-PNIPAAM-CBE nanoparticles effectively inhibited spoilage microorganisms' growth and extended fresh-cut lettuce shelf-life. Overall, nanoencapsulation provided a method to effectively deliver essential oil and enhanced produce safety, while creating little to no detrimental quality changes on the fresh-cut lettuce. © 2017 Institute of Food Technologists®.

The Kaiser Permanente implant registries: effect on patient safety, quality improvement, cost effectiveness, and research opportunities.

PubMed

Paxton, Elizabeth W; Inacio, Maria Cs; Kiley, Mary-Lou

2012-01-01

Considering the high cost, volume, and patient safety issues associated with medical devices, monitoring of medical device performance is critical to ensure patient safety and quality of care. The purpose of this article is to describe the Kaiser Permanente (KP) implant registries and to highlight the benefits of these implant registries on patient safety, quality, cost effectiveness, and research. Eight KP implant registries leverage the integrated health care system's administrative databases and electronic health records system. Registry data collected undergo quality control and validation as well as statistical analysis. Patient safety has been enhanced through identification of affected patients during major recalls, identification of risk factors associated with outcomes of interest, development of risk calculators, and surveillance programs for infections and adverse events. Effective quality improvement activities included medical center- and surgeon-specific profiles for use in benchmarking reports, and changes in practice related to registry information output. Among the cost-effectiveness strategies employed were collaborations with sourcing and contracting groups, and assistance in adherence to formulary device guidelines. Research studies using registry data included postoperative complications, resource utilization, infection risk factors, thromboembolic prophylaxis, effects of surgical delay on concurrent injuries, and sports injury patterns. The unique KP implant registries provide important information and affect several areas of our organization, including patient safety, quality improvement, cost-effectiveness, and research.

[The Scope, Quality and Safety Requirements of Drug Abuse Testing].

PubMed

Küme, Tuncay; Karakükcü, Çiğdem; Pınar, Aslı; Coşkunol, Hakan

2017-01-01

The aim of this review is to inform about the scopes and requirements of drug abuse testing. Drug abuse testing is one of the tools for determination of drug use. It must fulfill the quality and safety requirements in judgmental legal and administrative decisions. Drug abuse testing must fulfill some requirements like selection of the appropriate test matrix, appropriate screening test panel, sampling in detection window, patient consent, identification of the donor, appropriate collection site, sample collection with observation, identification and control of the sample, specimen custody chain in preanalytical phase; analysis in authorized laboratories, specimen validity tests, reliable testing METHODS, strict quality control, two-step analysis in analytical phase; storage of the split specimen, confirmation of the split specimen in the objection, result custody chain, appropriate cut-off concentration, the appropriate interpretation of the result in postanalytical phase. The workflow and analytical processes of drug abuse testing are explained in last regulation of the Department of Medical Laboratory Services, Ministry of Health in Turkey. The clinical physicians have to know and apply the quality and safety requirements in drug abuse testing according to last regulations in Turkey.

[Testing of medicinal products produced from pooled plasma].

PubMed

Unkelbach, U; Hunfeld, A; Breitner-Ruddock, S

2014-10-01

Medicinal products produced from human plasma fall under the administrative batch release procedure of the competent authority. In Germany, this has been carried out since 1995 by the Paul Ehrlich Institute (PEI), the responsible state control agency for blood products. Medicinal products released for the European and national market are tested for quality, efficacy and safety. Experimental testing of the final product and the starting materials, the plasma pools, as well as control of the production documentation guarantee a constantly high product safety. In the 28,000 batches tested since the beginning of the state controlled batch release testing of these blood products at the PEI, there has been no transmission of infectious viruses (HIV, HBV and HCV) to any patient. The batch release has made a contribution to the improvement of product quality. This procedure is still an important tool to ensure safety of blood products. The PEI is integrated in the batch release network of the European Directorate for the Quality of Medicines & Health Care (EDQM) in Strasbourg. Regulations and guidelines for official control authority batch release (OCABR) ensure harmonized procedures for mutual recognition of batch release on the European level. The EU certificates and German national certificates are requested and accepted in over 70 countries worldwide. Experimental testing in the EU and the requisite certificates have developed into a seal of quality for the world market.

[Introduction of hazard analysis and critical control points (HACCP) principles at the flight catering food production plant].

PubMed

Popova, A Yu; Trukhina, G M; Mikailova, O M

In the article there is considered the quality control and safety system implemented in the one of the largest flight catering food production plant for airline passengers and flying squad. The system for the control was based on the Hazard Analysis And Critical Control Points (HACCP) principles and developed hygienic and antiepidemic measures. There is considered the identification of hazard factors at stages of the technical process. There are presented results of the analysis data of monitoring for 6 critical control points over the five-year period. The quality control and safety system permit to decline food contamination risk during acceptance, preparation and supplying of in-flight meal. There was proved the efficiency of the implemented system. There are determined further ways of harmonization and implementation for HACCP principles in the plant.

Association between poor sleep, fatigue, and safety outcomes in Emergency Medical Services providers

PubMed Central

Patterson, P. Daniel; Weaver, Matthew D.; Frank, Rachel C.; Warner, Charles W.; Martin-Gill, Christian; Guyette, Francis X.; Fairbanks, Rollin J.; Hubble, Michael W.; Songer, Thomas J.; Callaway, Clifton W.; Kelsey, Sheryl F.; Hostler, David

2011-01-01

Objective To determine the association between poor sleep quality, fatigue, and self-reported safety outcomes among Emergency Medical Services (EMS) workers. Methods We used convenience sampling of EMS agencies and a cross-sectional survey design. We administered the 19-item Pittsburgh Sleep Quality Index (PSQI), 11-item Chalder Fatigue Questionnaire (CFQ), and 44-item EMS Safety Inventory (EMS-SI) to measure sleep quality, fatigue, and safety outcomes, respectively. We used a consensus process to develop the EMS-SI, which was designed to capture three composite measurements of EMS worker injury, medical errors and adverse events (AE), and safety compromising behaviors. We used hierarchical logistic regression to test the association between poor sleep quality, fatigue, and three composite measures of EMS worker safety outcomes. Results We received 547 surveys from 30 EMS agencies (a 35.6% mean agency response rate). The mean PSQI score exceeded the benchmark for poor sleep (6.9, 95%CI 6.6, 7.2). Greater than half of respondents were classified as fatigued (55%, 95%CI 50.7, 59.3). Eighteen percent of respondents reported an injury (17.8%, 95%CI 13.5, 22.1), forty-one percent a medical error or AE (41.1%, 95%CI 36.8, 45.4), and 89% (95%CI 87, 92) safety compromising behaviors. After controlling for confounding, we identified 1.9 greater odds of injury (95%CI 1.1, 3.3), 2.2 greater odds of medical error or AE (95%CI 1.4, 3.3), and 3.6 greater odds of safety compromising behavior (95%CI 1.5, 8.3) among fatigued respondents versus non-fatigued respondents. Conclusions In this sample of EMS workers, poor sleep quality and fatigue is common. We provide preliminary evidence of an association between sleep quality, fatigue, and safety outcomes. PMID:22023164

42 CFR 84.42 - Proposed quality control plans; approval by the Institute.

Code of Federal Regulations, 2011 CFR

2011-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for...

42 CFR 84.42 - Proposed quality control plans; approval by the Institute.

Code of Federal Regulations, 2014 CFR

2014-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for...

42 CFR 84.42 - Proposed quality control plans; approval by the Institute.

Code of Federal Regulations, 2013 CFR

2013-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for...

42 CFR 84.42 - Proposed quality control plans; approval by the Institute.

Code of Federal Regulations, 2010 CFR

2010-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for...

42 CFR 84.42 - Proposed quality control plans; approval by the Institute.

Code of Federal Regulations, 2012 CFR

2012-10-01

... OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES... determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for...

Advanced strategies for quality control of Chinese medicines.

PubMed

Zhao, Jing; Ma, Shuang-Cheng; Li, Shao-Ping

2018-01-05

Quality control is always the critical issue for Chinese medicines (CMs) with their worldwide increasing use. Different from western medicine, CMs are usually considered that multiple constituents are responsible for the therapeutic effects. Therefore, quality control of CMs is a challenge. In 2011, the strategies for quantification, related to the markers, reference compounds and approaches, in quality control of CMs were reviewed (Li, et al., J. Pharm. Biomed. Anal., 2011, 55, 802-809). Since then, some new strategies have been proposed in these fields. Therefore, the review on the strategies for quality control of CMs should be updated to improve the safety and efficacy of CMs. Herein, novel strategies related to quality marker discovery, reference compound development and advanced approaches (focused on glyco-analysis) for quality control, during 2011-2016, were summarized and discussed. Copyright © 2017 Elsevier B.V. All rights reserved.

Effect of Community Engagement Interventions on Patient Safety and Risk Reduction Efforts in Primary Health Facilities: Evidence from Ghana

PubMed Central

Alhassan, Robert Kaba; Nketiah-Amponsah, Edward; Spieker, Nicole; Arhinful, Daniel Kojo; Ogink, Alice; van Ostenberg, Paul; Rinke de Wit, Tobias F.

2015-01-01

Background Patient safety and quality care remain major challenges to Ghana’s healthcare system. Like many health systems in Africa, this is largely because demand for healthcare is outstripping available human and material resource capacity of healthcare facilities and new investment is insufficient. In the light of these demand and supply constraints, systematic community engagement (SCE) in healthcare quality assessment can be a feasible and cost effective option to augment existing quality improvement interventions. SCE entails structured use of existing community groups to assess healthcare quality in health facilities. Identified quality gaps are discussed with healthcare providers, improvements identified and rewards provided if the quality gaps are closed. Purpose This paper evaluates whether or not SCE, through the assessment of health service quality, improves patient safety and risk reduction efforts by staff in healthcare facilities. Methods A randomized control trail was conducted in 64 primary healthcare facilities in the Greater Accra and Western regions of Ghana. Patient risk assessments were conducted in 32 randomly assigned intervention and control facilities. Multivariate multiple regression test was used to determine effect of the SCE interventions on staff efforts towards reducing patient risk. Spearman correlation test was used to ascertain associations between types of community groups engaged and risk assessment scores of healthcare facilities. Findings Clinic staff efforts towards increasing patient safety and reducing risk improved significantly in intervention facilities especially in the areas of leadership/accountability (Coef. = 10.4, p<0.05) and staff competencies (Coef. = 7.1, p<0.05). Improvement in service utilization and health resources could not be attributed to the interventions because these were outside the control of the study and might have been influenced by institutional or national level developments between the baseline and follow-up period. Community groups that were gender balanced, religious/faith-based, and had structured leadership appeared to be better options for effective SCE in healthcare quality assessment. Conclusion Community engagement in healthcare quality assessment is a feasible client-centered quality improvement option that should be discussed for possible scale-up in Ghana and other resource poor countries in Africa. PMID:26619143

Effect of Community Engagement Interventions on Patient Safety and Risk Reduction Efforts in Primary Health Facilities: Evidence from Ghana.

PubMed

Alhassan, Robert Kaba; Nketiah-Amponsah, Edward; Spieker, Nicole; Arhinful, Daniel Kojo; Ogink, Alice; van Ostenberg, Paul; Rinke de Wit, Tobias F

2015-01-01

Patient safety and quality care remain major challenges to Ghana's healthcare system. Like many health systems in Africa, this is largely because demand for healthcare is outstripping available human and material resource capacity of healthcare facilities and new investment is insufficient. In the light of these demand and supply constraints, systematic community engagement (SCE) in healthcare quality assessment can be a feasible and cost effective option to augment existing quality improvement interventions. SCE entails structured use of existing community groups to assess healthcare quality in health facilities. Identified quality gaps are discussed with healthcare providers, improvements identified and rewards provided if the quality gaps are closed. This paper evaluates whether or not SCE, through the assessment of health service quality, improves patient safety and risk reduction efforts by staff in healthcare facilities. A randomized control trail was conducted in 64 primary healthcare facilities in the Greater Accra and Western regions of Ghana. Patient risk assessments were conducted in 32 randomly assigned intervention and control facilities. Multivariate multiple regression test was used to determine effect of the SCE interventions on staff efforts towards reducing patient risk. Spearman correlation test was used to ascertain associations between types of community groups engaged and risk assessment scores of healthcare facilities. Clinic staff efforts towards increasing patient safety and reducing risk improved significantly in intervention facilities especially in the areas of leadership/accountability (Coef. = 10.4, p<0.05) and staff competencies (Coef. = 7.1, p<0.05). Improvement in service utilization and health resources could not be attributed to the interventions because these were outside the control of the study and might have been influenced by institutional or national level developments between the baseline and follow-up period. Community groups that were gender balanced, religious/faith-based, and had structured leadership appeared to be better options for effective SCE in healthcare quality assessment. Community engagement in healthcare quality assessment is a feasible client-centered quality improvement option that should be discussed for possible scale-up in Ghana and other resource poor countries in Africa.

42 CFR 84.43 - Quality control records; review by the Institute; revocation of approval.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Quality control records; review by the Institute; revocation of approval. 84.43 Section 84.43 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY...

42 CFR 84.43 - Quality control records; review by the Institute; revocation of approval.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Quality control records; review by the Institute; revocation of approval. 84.43 Section 84.43 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY...

42 CFR 84.43 - Quality control records; review by the Institute; revocation of approval.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Quality control records; review by the Institute; revocation of approval. 84.43 Section 84.43 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY...

42 CFR 84.43 - Quality control records; review by the Institute; revocation of approval.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Quality control records; review by the Institute; revocation of approval. 84.43 Section 84.43 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY...

42 CFR 84.43 - Quality control records; review by the Institute; revocation of approval.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Quality control records; review by the Institute; revocation of approval. 84.43 Section 84.43 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY...

Considering chance in quality and safety performance measures: an analysis of performance reports by boards in English NHS trusts.

PubMed

Schmidtke, Kelly Ann; Poots, Alan J; Carpio, Juan; Vlaev, Ivo; Kandala, Ngianga-Bakwin; Lilford, Richard J

2017-01-01

Hospital board members are asked to consider large amounts of quality and safety data with a duty to act on signals of poor performance. However, in order to do so it is necessary to distinguish signals from noise (chance). This article investigates whether data in English National Health Service (NHS) acute care hospital board papers are presented in a way that helps board members consider the role of chance in their decisions. Thirty English NHS trusts were selected at random and their board papers retrieved. Charts depicting quality and safety were identified. Categorical discriminations were then performed to document the methods used to present quality and safety data in board papers, with particular attention given to whether and how the charts depicted the role of chance, that is, by including control lines or error bars. Thirty board papers, containing a total of 1488 charts, were sampled. Only 88 (6%) of these charts depicted the role of chance, and only 17 of the 30 board papers included any charts depicting the role of chance. Of the 88 charts that attempted to represent the role of chance, 16 included error bars and 72 included control lines. Only 6 (8%) of the 72 control charts indicated where the control lines had been set (eg, 2 vs 3 SDs). Hospital board members are expected to consider large amounts of information. Control charts can help board members distinguish signals from noise, but often boards are not using them. We discuss demand-side and supply-side barriers that could be overcome to increase use of control charts in healthcare. 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/.

Evaluation of boldenone as a growth promoter in broilers: safety and meat quality aspects.

PubMed

Elmajdoub, Abdelrazzag; Garbaj, Aboubaker; Abolghait, Said; El-Mahmoudy, Abubakr

2016-04-01

The object of this study was to evaluate the safety and meat quality criteria in broilers following intramuscular injection of boldenone. Twenty-four broiler chicks, divided into two groups, were used in the present study. Boldenone was injected intramuscularly at a single-dose level of 5 mg/kg body weight into 12 broiler chicks at 2 weeks old; the other 12 chicks were injected with sesame oil and kept as controls. Blood samples were collected from the wing and metatarsal veins after 1, 2, and 3 weeks through the experimental course for hematological and clinic-chemical safety parameters. On the last day, chicks were humanely sacrificed and livers and kidneys were removed for histopathological examination. Breast muscles were also removed to assess meat-quality parameters. Boldenone significantly (p < 0.05) increased total erythrocytic count and hemoglobin and hematocrit values, while mean corpuscular hemoglobin and mean corpuscular hemoglobin concentration indices decreased. Leukogram showed leukopenia, lymphopenia, and granulocytosis (p < 0.05) as compared to control. Hepatorenal biomarkers, including alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, urea, and creatinine were significantly (p < 0.05) higher than the corresponding control values. Additionally, boldenone significantly (p < 0.05) increased metabolic markers, including total protein, globulins, cholesterol, triacylglycerols, and glucose, with parallel decreases in albumin and albumin/globulin ratio. Degenerative changes were recorded in liver and kidney tissues from chicks treated with boldenone. Muscle samples exhibited raised pH values and higher microbial counts as compared to the corresponding control. These data may discourage the use of boldenone as a growth promoter in broilers due to safety and meat quality reasons. Copyright © 2016. Published by Elsevier B.V.

[Technological innovations in radiation oncology require specific quality controls].

PubMed

Lenaerts, E; Mathot, M

2014-01-01

During the last decade, the field of radiotherapy has benefited from major technological innovations and continuously improving treatment efficacy, comfort and safety of patients. This mainly concerns the imaging techniques that allow 4D CT scan recording the respiratory phases, on-board imaging on linear accelerators that ensure perfect positioning of the patient for treatment and irradiation techniques that reduce very significantly the duration of treatment sessions without compromising quality of the treatment plan, including IMRT (Intensity Modulated Radiation Therapy) and VMAT (Volumetric Modulated Arc therapy). In this context of rapid technological change, it is the responsibility of medical physicists to regularly and precisely monitor the perfect functioning of new techniques to ensure patient safety. This requires the use of specific quality control equipment best suited to these new techniques. We will briefly describe the measurement system Delta4 used to control individualized treatment plan for each patient treated with VMAT technology.

Effects of efforts to optimise morbidity and mortality rounds to serve contemporary quality improvement and educational goals: a systematic review.

PubMed

Smaggus, Andrew; Mrkobrada, Marko; Marson, Alanna; Appleton, Andrew

2018-01-01

The quality and safety movement has reinvigorated interest in optimising morbidity and mortality (M&M) rounds. We performed a systematic review to identify effective means of updating M&M rounds to (1) identify and address quality and safety issues, and (2) address contemporary educational goals. Relevant databases (Medline, Embase, PubMed, Education Resource Information Centre, Cumulative Index to Nursing and Allied Health Literature, Healthstar, and Global Health) were searched to identify primary sources. Studies were included if they (1) investigated an intervention applied to M&M rounds, (2) reported outcomes relevant to the identification of quality and safety issues, or educational outcomes relevant to quality improvement (QI), patient safety or general medical education and (3) included a control group. Study quality was assessed using the Medical Education Research Study Quality Instrument and Newcastle-Ottawa Scale-Education instruments. Given the heterogeneity of interventions and outcome measures, results were analysed thematically. The final analysis included 19 studies. We identified multiple effective strategies (updating objectives, standardising elements of rounds and attaching rounds to a formal quality committee) to optimise M&M rounds for a QI/safety purpose. These efforts were associated with successful integration of quality and safety content into rounds, and increased implementation of QI interventions. Consistent effects on educational outcomes were difficult to identify, likely due to the use of methodologies ill-fitted for educational research. These results are encouraging for those seeking to optimise the quality and safety mission of M&M rounds. However, the inability to identify consistent educational effects suggests the investigation of M&M rounds could benefit from additional methodologies (qualitative, mixed methods) in order to understand the complex mechanisms driving learning at M&M rounds. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

10 CFR 71.101 - Quality assurance requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... quality assurance actions related to control of the physical characteristics and quality of the material... through 71.137 and satisfying any specific provisions that are applicable to the licensee's activities... assurance requirement's importance to safety. (c) Approval of program. (1) Before the use of any package for...

NAVIGATING A QUALITY ROUTE TO A NATIONAL SAFETY AWARD

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

PREVETTE SS

Deming quality methodologies applied to safety are recognized with the National Safety Council's annual Robert W. Campbell Award. Over the last ten years, the implementation of Statistical Process Control and quality methodologies at the U.S. Department of Energy's Hanford Site have contributed to improved safety. Improvements attributed to Statistical Process Control are evidenced in Occupational Safety and Health records and documented through several articles in Quality Progress and the American Society of Safety Engineers publication, Professional Safety. Statistical trending of safety, quality, and occurrence data continues to playa key role in improving safety and quality at what has been calledmore » the world's largest environmental cleanup project. DOE's Hanford Site played a pivotal role in the nation's defense beginning in the 1940s, when it was established as part of the Manhattan Project. After more than 50 years of producing material for nuclear weapons, Hanford, which covers 586 square miles in southeastern Washington state, is now focused on three outcomes: (1) Restoring the Columbia River corridor for multiple uses; (2) Transitioning the central plateau to support long-term waste management; and (3) Putting DOE assets to work for the future. The current environmental cleanup mission faces challenges of overlapping technical, political, regulatory, environmental, and cultural interests. From Oct. 1, 1996 through Sept. 30, 2008, Fluor Hanford was a prime contractor to the Department of Energy's Richland Operations Office. In this role, Fluor Hanford managed several major cleanup activities that included dismantling former nuclear-processing facilities, cleaning up the Site's contaminated groundwater, retrieving and processing transuranic waste for shipment and disposal off-site, maintaining the Site's infrastructure, providing security and fire protection, and operating the Volpentest HAMMER Training and Education Center. On October 1,2008, a transition occurred that changed Fluor's role at Hanford. Fluor's work at Hanford was split in two with the technical scope being assumed by the CH2M HILL Plateau Remediation Company (CHPRC) CHPRC is now spearheading much of the cleanup work associated with former nuclear-processing facilities, contaminated groundwater, and transuranic waste. Fluor is an integrated subcontractor to CH PRC in this effort. In addition, at the time of this writing, while the final outcome is being determined for the new Mission Support Contract, Fluor Hanford has had its contract extended to provide site-wide services that include security, fire protection, infrastructure, and operating the HAMMER facility. The emphasis has to be on doing work safely, delivering quality work, controlling costs, and meeting deadlines. Statistical support is provided by Fluor to the PRC, within Fluor Hanford, and to a third contractor, Washington Closure Hanford, which is tasked with cleaning up approximately 210 square miles designated as the Columbia River corridor along the outer edge of the Hanford Site. The closing months of Fluor Hanford's 12 year contract were busy, characterized by special events that capped its work as a prime cleanup contractor, transitions of work scope and personnel, and the completion numerous activities. At this time, Fluor's work and approach to safety were featured in state and national forums. A 'Blockbuster' presentation at the Washington State Governor's Industrial Safety Conference in September 2008 featured Fluor Hanford's Chief Operating Officer, a company Safety Representative, and me. Simultaneously, an award ceremony in Anaheim, Calif. recognized Fluor Hanford as the winner of the 2008 Robert W. Campbell Award. The Robert W. Campbell Award is co-sponsored by Exxon Mobil Corporation and the National Safety Council. Named after a pioneer of industrial safety, the Campbell Award recognizes organizations that demonstrate how integration of environmental, health and safety (EHS) management into business operations is a cornerstone of their corporate success. Fluor Hanford received the award for corporations with more than 1,000 employees. Campbell Award winners undergo rigorous assessments that include site visits and comprehensive evaluations of their commitment to, and implementation of, EHS practices. Award winners work with an international partnership of 21 organizations to develop case studies that illustrate their superior EHS programs and best practices, for use by top business and engineering schools worldwide. Quality methodologies in place at Fluor Hanford played a key role in the award process. Fluor Hanford's integrated use of Statistical Process Control and Pareto Charts for analyzing and displaying EHS performance were viewed favorably by the award judges.« less

Approaches to Quality Risk Management When Using Single-Use Systems in the Manufacture of Biologics.

PubMed

Ishii-Watabe, Akiko; Hirose, Akihiko; Katori, Noriko; Hashii, Norikata; Arai, Susumu; Awatsu, Hirotoshi; Eiza, Akira; Hara, Yoshiaki; Hattori, Hideshi; Inoue, Tomomi; Isono, Tetsuya; Iwakura, Masahiro; Kajihara, Daisuke; Kasahara, Nobuo; Matsuda, Hiroyuki; Murakami, Sei; Nakagawa, Taishiro; Okumura, Takehiro; Omasa, Takeshi; Takuma, Shinya; Terashima, Iyo; Tsukahara, Masayoshi; Tsutsui, Maiko; Yano, Takahiro; Kawasaki, Nana

2015-10-01

Biologics manufacturing technology has made great progress in the last decade. One of the most promising new technologies is the single-use system, which has improved the efficiency of biologics manufacturing processes. To ensure safety of biologics when employing such single-use systems in the manufacturing process, various issues need to be considered including possible extractables/leachables and particles arising from the components used in single-use systems. Japanese pharmaceutical manufacturers, together with single-use suppliers, members of the academia and regulatory authorities have discussed the risks of using single-use systems and established control strategies for the quality assurance of biologics. In this study, we describe approaches for quality risk management when employing single-use systems in the manufacturing of biologics. We consider the potential impact of impurities related to single-use components on drug safety and the potential impact of the single-use system on other critical quality attributes as well as the stable supply of biologics. We also suggest a risk-mitigating strategy combining multiple control methods which includes the selection of appropriate single-use components, their inspections upon receipt and before releasing for use and qualification of single-use systems. Communication between suppliers of single-use systems and the users, as well as change controls in the facilities both of suppliers and users, are also important in risk-mitigating strategies. Implementing these control strategies can mitigate the risks attributed to the use of single-use systems. This study will be useful in promoting the development of biologics as well as in ensuring their safety, quality and stable supply.

Treatment of Knee Osteoarthritis With Allogeneic Bone Marrow Mesenchymal Stem Cells: A Randomized Controlled Trial.

PubMed

Vega, Aurelio; Martín-Ferrero, Miguel Angel; Del Canto, Francisco; Alberca, Mercedes; García, Veronica; Munar, Anna; Orozco, Lluis; Soler, Robert; Fuertes, Juan Jose; Huguet, Marina; Sánchez, Ana; García-Sancho, Javier

2015-08-01

Osteoarthritis is the most prevalent joint disease and a common cause of joint pain, functional loss, and disability. Conventional treatments demonstrate only modest clinical benefits without lesion reversal. Autologous mesenchymal stromal cell (MSC) treatments have shown feasibility, safety, and strong indications for clinical efficacy. We performed a randomized, active control trial to assess the feasibility and safety of treating osteoarthritis with allogeneic MSCs, and we obtain information regarding the efficacy of this treatment. We randomized 30 patients with chronic knee pain unresponsive to conservative treatments and showing radiological evidence of osteoarthritis into 2 groups of 15 patients. The test group was treated with allogeneic bone marrow MSCs by intra-articular injection of 40 × 10(6) cells. The control group received intra-articular hyaluronic acid (60 mg, single dose). Clinical outcomes were followed for 1 year and included evaluations of pain, disability, and quality of life. Articular cartilage quality was assessed by quantitative magnetic resonance imaging T2 mapping. Feasibility and safety were confirmed and indications of clinical efficacy were identified. The MSC-treated patients displayed significant improvement in algofunctional indices versus the active controls treated with hyaluronic acid. Quantification of cartilage quality by T2 relaxation measurements showed a significant decrease in poor cartilage areas, with cartilage quality improvements in MSC-treated patients. Allogeneic MSC therapy may be a valid alternative for the treatment of chronic knee osteoarthritis that is more logistically convenient than autologous MSC treatment. The intervention is simple, does not require surgery, provides pain relief, and significantly improves cartilage quality.

Application of a risk management system to improve drinking water safety.

PubMed

Jayaratne, Asoka

2008-12-01

The use of a comprehensive risk management framework is considered a very effective means of managing water quality risks. There are many risk-based systems available to water utilities such as ISO 9001 and Hazard Analysis and Critical Control Point (HACCP). In 2004, the World Health Organization's (WHO) Guidelines for Drinking Water Quality recommended the use of preventive risk management approaches to manage water quality risks. This paper describes the framework adopted by Yarra Valley Water for the development of its Drinking Water Quality Risk Management Plan incorporating HACCP and ISO 9001 systems and demonstrates benefits of Water Safety Plans such as HACCP. Copyright IWA Publishing 2008.

A systematic review of randomized controlled trials for prevention or treatment of atopic dermatitis in dogs: 2008-2011 update.

PubMed

Olivry, Thierry; Bizikova, Petra

2013-02-01

The management of atopic dermatitis (AD) in dogs relies mainly on the use of interventions to reduce pruritus and skin lesions. To provide a critical analysis of recent clinical trials reporting the efficacy and safety of interventions for canine AD. Systematic review of randomized controlled trials (RCTs) published, presented or completed between 2008 and 2011, which enrolled dogs with AD. The search was done using electronic databases, reviewing published meeting abstracts and sending queries to professional email lists. Trials reporting the efficacy of interventions aimed at treating, preventing or reducing glucocorticoid usage in atopic dogs were selected. Twenty-one RCTs were included. We found further moderate-quality evidence of efficacy and safety of oral glucocorticoids and ciclosporin for treatment of canine AD. There was additional moderate-quality evidence of the efficacy of a topical glucocorticoid spray containing hydrocortisone aceponate. Low-quality evidence was found for the efficacy and safety of injectable recombinant interferons, a budesonide leave-on conditioner, a ciclosporin topical nano-emulsion and oral fexofenadine. There is low-quality evidence of efficacy of oral masitinib, with a need for monitoring for protein-losing nephropathy. Finally, we uncovered low-quality evidence of efficacy of a commercial diet as a glucocorticoid-sparing intervention and of a glucocorticoid spray as a flare-delaying measure. Very low-quality evidence was found for the efficacy of other interventions. Topical or oral glucocorticoids and oral ciclosporin remain the interventions with highest evidence for efficacy and relative safety for treatment of canine AD. © 2013 The Authors. Veterinary Dermatology © 2013 ESVD and ACVD.

Automatic and remote controlled ictal SPECT injection for seizure focus localization by use of a commercial contrast agent application pump.

PubMed

Feichtinger, Michael; Eder, Hans; Holl, Alexander; Körner, Eva; Zmugg, Gerda; Aigner, Reingard; Fazekas, Franz; Ott, Erwin

2007-07-01

In the presurgical evaluation of patients with partial epilepsy, the ictal single photon emission computed tomography (SPECT) is a useful noninvasive diagnostic tool for seizure focus localization. To achieve optimal SPECT scan quality, ictal tracer injection should be carried out as quickly as possible after the seizure onset and under highest safety conditions possible. Compared to the commonly used manual injection, an automatic administration of the radioactive tracer may provide higher quality standards for this procedure. In this study, therefore, we retrospectively analyzed efficiency and safety of an automatic injection system for ictal SPECT tracer application. Over a 31-month period, 26 patients underwent ictal SPECT by use of an automatic remote-controlled injection pump originally designed for CT-contrast agent application. Various factors were reviewed, including latency of ictal injection, radiation safety parameters, and ictal seizure onset localizing value. Times between seizure onset and tracer injection ranged between 3 and 48 s. In 21 of 26 patients ictal SPECT supported the localization of the epileptogenic focus in the course of the presurgical evaluation. In all cases ictal SPECT tracer injection was performed with a high degree of safety to patients and staff. Ictal SPECT by use of a remote-controlled CT-contrast agent injection system provides a high scan quality and is a safe and confirmatory presurgical evaluation technique in the epilepsy-monitoring unit.

Safety considerations of lithium-thionyl chloride cells

NASA Astrophysics Data System (ADS)

Subbarao, Surampudi; Halpert, Gerald; Stein, Irving

1986-06-01

The use of spirally wound lithium-thionyl chloride (Li-SOCl2) cells is currently limited because of their hazardous behavior. Safety hazards have ranged from mild venting of toxic materials to violent explosions and fires. These incidents may be related to both user- and manufacturer-induced causes. Many explanations have been offered to explain the unsafe behavior of the cells under operating and abuse conditions. Explanations fall into two categories: (1) thermal mechanisms, and (2) chemical mechanisms. However, it is quite difficult to separate the two. Both may be responsible for cell venting or explosion. Some safety problems encountered with these cells also may be due to design deficiencies and ineffective quality control during cell fabrication. A well-coordinated basic and applied research program is needed to develop safe Li-SOCl2 cells. Recommendations include: (1) learnig more about Li-SOL2 cell chemistry; (2) modeling cell and battery behavior; (3) optimizing cell design for safety and performance, (4) implementing quality control procedures; and (5) educating users.

Safety considerations of lithium-thionyl chloride cells

NASA Technical Reports Server (NTRS)

Subbarao, Surampudi; Halpert, Gerald; Stein, Irving

1986-01-01

The use of spirally wound lithium-thionyl chloride (Li-SOCl2) cells is currently limited because of their hazardous behavior. Safety hazards have ranged from mild venting of toxic materials to violent explosions and fires. These incidents may be related to both user- and manufacturer-induced causes. Many explanations have been offered to explain the unsafe behavior of the cells under operating and abuse conditions. Explanations fall into two categories: (1) thermal mechanisms, and (2) chemical mechanisms. However, it is quite difficult to separate the two. Both may be responsible for cell venting or explosion. Some safety problems encountered with these cells also may be due to design deficiencies and ineffective quality control during cell fabrication. A well-coordinated basic and applied research program is needed to develop safe Li-SOCl2 cells. Recommendations include: (1) learnig more about Li-SOL2 cell chemistry; (2) modeling cell and battery behavior; (3) optimizing cell design for safety and performance, (4) implementing quality control procedures; and (5) educating users.

Safety issues with herbal products.

PubMed

Marrone, C M

1999-12-01

To review safety issues associated with the use of herbal products. Literature accessed through MEDLINE and other Internet search engines. Key search terms included herbs, dietary supplements, and safety. A misconception exists among consumers that herbal remedies are safe because they are natural. In an effort to provide healthcare practitioners with information necessary for a patient discussion, a review of safety concerns with herbal products was conducted. Several safety concerns exist with herbal products including lack of safety data, absence of quality-control requirements for potency and purity, and lenient labeling standards.

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

PubMed

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

2009-01-01

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

DASHBOARDS & CONTROL CHARTS EXPERIENCES IN IMPROVING SAFETY AT HANFORD WASHINGTON

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

PREVETTE, S.S.

2006-02-27

The aim of this paper is to demonstrate the integration of safety methodology, quality tools, leadership, and teamwork at Hanford and their significant positive impact on safe performance of work. Dashboards, Leading Indicators, Control charts, Pareto Charts, Dr. W. Edward Deming's Red Bead Experiment, and Dr. Deming's System of Profound Knowledge have been the principal tools and theory of an integrated management system. Coupled with involved leadership and teamwork, they have led to significant improvements in worker safety and protection, and environmental restoration at one of the nation's largest nuclear cleanup sites.

Controlling for quality in the hospital cost function.

PubMed

Carey, Kathleen; Stefos, Theodore

2011-06-01

This paper explores the relationship between the cost and quality of hospital care from the perspective of applied microeconomics. It addresses both theoretical and practical complexities entailed in incorporating hospital quality into the estimation of hospital cost functions. That literature is extended with an empirical analysis that examines the use of 15 Patient Safety Indicators (PSIs) as measures of hospital quality. A total operating cost function is estimated on 2,848 observations from five states drawn from the period 2001 to 2007. In general, findings indicate that the PSIs are successful in capturing variation in hospital cost due to adverse patient safety events. Measures that rely on the aggregate number of adverse events summed over PSIs are found to be superior to risk-adjusted rates for individual PSIs. The marginal cost of an adverse event is estimated to be $22,413. The results contribute to a growing business case for inpatient safety in hospital services.

76 FR 9025 - Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-16

... consumer protection, the Agency issued GLP regulations. The regulations specify minimum standards for the proper conduct of safety testing and contain sections on facilities, personnel, equipment, standard operating procedures (SOPs), test and control articles, quality assurance, protocol and conduct of a safety...

Management of microbial food safety in the Arab countries

USDA-ARS?s Scientific Manuscript database

Microbial food safety remains a major economical and public health concern in the Arab countries. Over the several past years, many of these countries have attempted to revise and upgrade food quality control and surveillance programs. However, these systems vary in scope and effectiveness. This rev...

U.S. Army Public Health Command (Provisional ) - Organization Overview and Environmental Health Engineering Services

DTIC Science & Technology

2010-06-15

Veterinary Medical care for Government-Owned Animals Zoonotic disease surveillance and control Food safety and food defense quality assurance...surveillance and epidemiology • Laboratory services • Health risk assessment • Zoonotic disease surveillance and control • Food safety and food...Command vs Technical – Lack of flexibility in resource cross leveling • 1994: VETCOM activated with HQ at Ft. Sam Houston Texas VETCOM Mission Food

[Study on the optimization of monitoring indicators of drinking water quality during health supervision].

PubMed

Ye, Bixiong; E, Xueli; Zhang, Lan

2015-01-01

To optimize non-regular drinking water quality indices (except Giardia and Cryptosporidium) of urban drinking water. Several methods including drinking water quality exceed the standard, the risk of exceeding standard, the frequency of detecting concentrations below the detection limit, water quality comprehensive index evaluation method, and attribute reduction algorithm of rough set theory were applied, redundancy factor of water quality indicators were eliminated, control factors that play a leading role in drinking water safety were found. Optimization results showed in 62 unconventional water quality monitoring indicators of urban drinking water, 42 water quality indicators could be optimized reduction by comprehensively evaluation combined with attribute reduction of rough set. Optimization of the water quality monitoring indicators and reduction of monitoring indicators and monitoring frequency could ensure the safety of drinking water quality while lowering monitoring costs and reducing monitoring pressure of the sanitation supervision departments.

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

NASA Technical Reports Server (NTRS)

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

2010-01-01

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

Effect on asphalt quality due to nighttime construction : final report.

DOT National Transportation Integrated Search

2017-06-01

The objectives of this project were to identify and analyze the nighttime paving traffic control standards in other states and compare the effects of daytime vs. nighttime paving on quality, safety, costs, and construction time. Surveys of various De...

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.

Quality and human society

NASA Astrophysics Data System (ADS)

Stoll, W.

1991-02-01

Quality of products and services is seen as a necessity in our modern world. Quality also has important cross-links to safety in our society. It is however suggested, that human beings are living in their industrial environment under the stress of a fractured personality with anxieties and frustrations. Some cultural comparisons with other industrial nations are given. Quality control tailored to human nature is recommended.

Effects of Individual Nurse and Hospital Characteristics on Patient Adverse Events and Quality of Care: A Multilevel Analysis.

PubMed

Lee, Seung Eun; Vincent, Catherine; Dahinten, V Susan; Scott, Linda D; Park, Chang Gi; Dunn Lopez, Karen

2018-06-14

This study aimed to investigate effects of individual nurse and hospital characteristics on patient adverse events and quality of care using a multilevel approach. This is a secondary analysis of a combination of nurse survey data (N = 1,053 nurses) and facility data (N = 63 hospitals) in Canada. Multilevel ordinal logistic regression was employed to examine effects of individual nurse and hospital characteristics on patient adverse events. Multilevel linear regressions were used to investigate effects of individual nurse and hospital characteristics on quality of care. Organizational safety culture was associated with patient adverse events and quality of care. Controlling for effects of nurse and hospital characteristics, nurses in hospitals with a stronger safety culture were 64% less likely to report administration of wrong medication, time, or dose; 58% less likely to report patient falls with injury; and 60% less likely to report urinary tract infections; and were more likely to report higher levels of quality of care. Additionally, the effects of individual-level baccalaureate education and years of experience on quality of care differed across hospitals, and hospital-level nurse education interacted with individual-level baccalaureate education. This study makes significant contributions to existing knowledge regarding the positive effect of organizational safety culture on patient adverse events and quality of care. Healthcare organizations should strive to improve their safety culture by creating environments where healthcare providers trust each other, work collaboratively, and share accountability for patient safety and care quality. © 2018 Sigma Theta Tau International.

Quantitative analysis of Sudan dye adulteration in paprika powder using FTIR spectroscopy

USDA-ARS?s Scientific Manuscript database

The presence of Sudan dye used illegally for coloring in food stuffs has become a point of food safety concern, especially in paprika- and chili-containing food products. Fourier transform infrared (FTIR) spectroscopy has been extensively used as an analytical method for quality control and safety m...

Applications of artificial neural networks (ANNs) in food science.

PubMed

Huang, Yiqun; Kangas, Lars J; Rasco, Barbara A

2007-01-01

Artificial neural networks (ANNs) have been applied in almost every aspect of food science over the past two decades, although most applications are in the development stage. ANNs are useful tools for food safety and quality analyses, which include modeling of microbial growth and from this predicting food safety, interpreting spectroscopic data, and predicting physical, chemical, functional and sensory properties of various food products during processing and distribution. ANNs hold a great deal of promise for modeling complex tasks in process control and simulation and in applications of machine perception including machine vision and electronic nose for food safety and quality control. This review discusses the basic theory of the ANN technology and its applications in food science, providing food scientists and the research community an overview of the current research and future trend of the applications of ANN technology in the field.

Selection of chemical markers for the quality control of medicinal plants of the genus Cecropia.

PubMed

Rivera-Mondragón, Andrés; Ortíz, Orlando O; Bijttebier, Sebastiaan; Vlietinck, Arnold; Apers, Sandra; Pieters, Luc; Caballero-George, Catherina

2017-12-01

Several Cecropia (Cecropiaceae) species are traditionally used in Latin America for the treatment of a variety of diseases including diabetes, arterial hypertension, asthma, bronchitis, anxiety, and inflammation. At present, a number of commercial products based on these plants have been introduced into the market with very little information on methods for guaranteeing their quality and safety. This work proposes potential chemical markers for the quality control of the raw materials of Cecropia obtusifolia Bertol., Cecropia peltata L., Cecropia glaziovii Snethl., Cecropia pachystachya Trécul, and Cecropia hololeuca Miq. The Herbal Chemical Marker Ranking System (Herb MaRS) developed by the National Institute of Complementary Medicine (NICM) at the University of Western Sydney was used for selecting chemical markers for the quality control of selected medicinal species of Cecropia. This review covers the period from 1982 to 2016. Chlorogenic acid, flavonoidal glycosides (orientin, isoorientin, vitexin, isovitexin, and rutin), catechin, epicatechin, procyanidins (B2, B5, and C1), steroids (β-sitosterol), and triterpenoids (α-amyrin, pomolic, tormentic and ursolic acids) were selected as chemical markers for the quality control of the leaves. It is necessary to establish comprehensive standards for guaranteeing quality, safety and efficacy of herbal drugs. The selection of adequate chemical markers for quality control purposes requires a good knowledge about the chemical composition of medicinal plants and their associated biological properties. To the best of our knowledge this review article is the first to address the identification and quantitative determination of the chemical markers for the genus Cecropia.

Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents).

PubMed

Calixto, J B

2000-02-01

This review highlights the current advances in knowledge about the safety, efficacy, quality control, marketing and regulatory aspects of botanical medicines. Phytotherapeutic agents are standardized herbal preparations consisting of complex mixtures of one or more plants which contain as active ingredients plant parts or plant material in the crude or processed state. A marked growth in the worldwide phytotherapeutic market has occurred over the last 15 years. For the European and USA markets alone, this will reach about $7 billion and $5 billion per annum, respectively, in 1999, and has thus attracted the interest of most large pharmaceutical companies. Insufficient data exist for most plants to guarantee their quality, efficacy and safety. The idea that herbal drugs are safe and free from side effects is false. Plants contain hundreds of constituents and some of them are very toxic, such as the most cytotoxic anti-cancer plant-derived drugs, digitalis and the pyrrolizidine alkaloids, etc. However, the adverse effects of phytotherapeutic agents are less frequent compared with synthetic drugs, but well-controlled clinical trials have now confirmed that such effects really exist. Several regulatory models for herbal medicines are currently available including prescription drugs, over-the-counter substances, traditional medicines and dietary supplements. Harmonization and improvement in the processes of regulation is needed, and the general tendency is to perpetuate the German Commission E experience, which combines scientific studies and traditional knowledge (monographs). Finally, the trend in the domestication, production and biotechnological studies and genetic improvement of medicinal plants, instead of the use of plants harvested in the wild, will offer great advantages, since it will be possible to obtain uniform and high quality raw materials which are fundamental to the efficacy and safety of herbal drugs.

[On the improvement of the legal support of the food safety in the conditions of trade and economic integration of states-members of the Customs union and the Russian Federation's accession to the WTO].

PubMed

Bragina, I V; Aksenova, O I; Bokit'ko, B G; Gorsky, A A

2013-01-01

In the article priority activities of The Federal Service for the Oversight of Consumer Protection and Welfare on improvement of standard legal support of safety of foodstuff and control of compliance of foodstuff to legislation requirements are reported. The main documents directed on harmonization of the international requirements with national ones and requirements of the Customs union on safety of foodstuff are submitted. Work within a framework of Russian Federation's accession to the WTO is described. And data on control of quality and safety of foodstuff are provided also.

Truth in Reporting: How Data Capture Methods Obfuscate Actual Surgical Site Infection Rates within a Health Care Network System.

PubMed

Bordeianou, Liliana; Cauley, Christy E; Antonelli, Donna; Bird, Sarah; Rattner, David; Hutter, Matthew; Mahmood, Sadiqa; Schnipper, Deborah; Rubin, Marc; Bleday, Ronald; Kenney, Pardon; Berger, David

2017-01-01

Two systems measure surgical site infection rates following colorectal surgeries: the American College of Surgeons National Surgical Quality Improvement Program and the Centers for Disease Control and Prevention National Healthcare Safety Network. The Centers for Medicare & Medicaid Services pay-for-performance initiatives use National Healthcare Safety Network data for hospital comparisons. This study aimed to compare database concordance. This is a multi-institution cohort study of systemwide Colorectal Surgery Collaborative. The National Surgical Quality Improvement Program requires rigorous, standardized data capture techniques; National Healthcare Safety Network allows 5 data capture techniques. Standardized surgical site infection rates were compared between databases. The Cohen κ-coefficient was calculated. This study was conducted at Boston-area hospitals. National Healthcare Safety Network or National Surgical Quality Improvement Program patients undergoing colorectal surgery were included. Standardized surgical site infection rates were the primary outcomes of interest. Thirty-day surgical site infection rates of 3547 (National Surgical Quality Improvement Program) vs 5179 (National Healthcare Safety Network) colorectal procedures (2012-2014). Discrepancies appeared: National Surgical Quality Improvement Program database of hospital 1 (N = 1480 patients) routinely found surgical site infection rates of approximately 10%, routinely deemed rate "exemplary" or "as expected" (100%). National Healthcare Safety Network data from the same hospital and time period (N = 1881) revealed a similar overall surgical site infection rate (10%), but standardized rates were deemed "worse than national average" 80% of the time. Overall, hospitals using less rigorous capture methods had improved surgical site infection rates for National Healthcare Safety Network compared with standardized National Surgical Quality Improvement Program reports. The correlation coefficient between standardized infection rates was 0.03 (p = 0.88). During 25 site-time period observations, National Surgical Quality Improvement Program and National Healthcare Safety Network data matched for 52% of observations (13/25). κ = 0.10 (95% CI, -0.1366 to 0.3402; p = 0.403), indicating poor agreement. This study investigated hospitals located in the Northeastern United States only. Variation in Centers for Medicare & Medicaid Services-mandated National Healthcare Safety Network infection surveillance methodology leads to unreliable results, which is apparent when these results are compared with standardized data. High-quality data would improve care quality and compare outcomes among institutions.

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.

Nuclear Technology Series. Course 8: Reactor Safety.

ERIC Educational Resources Information Center

Center for Occupational Research and Development, Inc., Waco, TX.

This technical specialty course is one of thirty-five courses designed for use by two-year postsecondary institutians in five nuclear technician curriculum areas: (1) radiation protection technician, (2) nuclear instrumentation and control technician, (3) nuclear materials processing technician, (4) nuclear quality-assurance/quality-control…

A day in the life of a pharmacovigilance case processor.

PubMed

Bhangale, Ritesh; Vaity, Sayali; Kulkarni, Niranjan

2017-01-01

Pharmacovigilance (PV) has grown significantly in India in the last couple of decades. The etymological roots for the word "pharmacovigilance" are "Pharmakon" (Greek for drug) and "Vigilare" (Latin for to keep watch). It relies on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. The PV data processing cycle starts with data collection in computerized systems followed by complete data entry which includes adverse event coding, drug coding, causality and expectedness assessment, narrative writing, quality control, and report submissions followed by data storage and maintenance. A case processor plays an important role in conducting these various tasks. The case processor should also manage drug safety information, possess updated knowledge about global drug safety regulations, summarize clinical safety data, participate in meetings, write narratives with medical input from a physician, report serious adverse events to the regulatory authorities, participate in the training of operational staff on drug safety issues, quality control work of other staff in the department, and take on any other task as assigned by the manager or medical director within the capabilities of the drug safety associate. There can be challenges while handling all these tasks at a time, hence the associate will have to maintain a balance to overcome them and keep on updating their knowledge on drug safety regulations, which in turn, would help in increasing their learning curve.

An Evaluation of the Effects of Human Factors and Ergonomics on Health Care and Patient Safety Practices: A Systematic Review

PubMed Central

Zhang, Longhao; Zhao, Pujing; Chen, Ying; Zhang, Mingming

2015-01-01

Background From the viewpoint of human factors and ergonomics (HFE), errors often occur because of the mismatch between the system, technique and characteristics of the human body. HFE is a scientific discipline concerned with understanding interactions between human behavior, system design and safety. Objective To evaluate the effectiveness of HFE interventions in improving health care workers’ outcomes and patient safety and to assess the quality of the available evidence. Methods We searched databases, including MEDLINE, EMBASE, BIOSIS Previews and the CBM (Chinese BioMedical Literature Database), for articles published from 1996 to Mar.2015. The quality assessment tool was based on the risk of bias criteria developed by the Cochrane Effective Practice and Organization of Care (EPOC) Group. The interventions of the included studies were categorized into four relevant domains, as defined by the International Ergonomics Association. Results For this descriptive study, we identified 8, 949 studies based on our initial search. Finally, 28 studies with 3,227 participants were included. Among the 28 included studies, 20 studies were controlled studies, two of which were randomized controlled trials. The other eight studies were before/after surveys, without controls. Most of the studies were of moderate or low quality. Five broad categories of outcomes were identified in this study: 1) medical errors or patient safety, 2) health care workers’ quality of working life (e.g. reduced fatigue, discomfort, workload, pain and injury), 3) user performance (e.g., efficiency or accuracy), 4) health care workers’ attitudes towards the interventions(e.g., satisfaction and preference), and 5) economic evaluations. Conclusion The results showed that the interventions positively affected the outcomes of health care workers. Few studies considered the financial merits of these interventions. Most of the included studies were of moderate quality. This review highlights the need for scientific and standardized guidelines regarding how HFE should be implemented in health care. PMID:26067774

Closed-loop control of anesthesia: a primer for anesthesiologists.

PubMed

Dumont, Guy A; Ansermino, J Mark

2013-11-01

Feedback control is ubiquitous in nature and engineering and has revolutionized safety in fields from space travel to the automobile. In anesthesia, automated feedback control holds the promise of limiting the effects on performance of individual patient variability, optimizing the workload of the anesthesiologist, increasing the time spent in a more desirable clinical state, and ultimately improving the safety and quality of anesthesia care. The benefits of control systems will not be realized without widespread support from the health care team in close collaboration with industrial partners. In this review, we provide an introduction to the established field of control systems research for the everyday anesthesiologist. We introduce important concepts such as feedback and modeling specific to control problems and provide insight into design requirements for guaranteeing the safety and performance of feedback control systems. We focus our discussion on the optimization of anesthetic drug administration.

Characterization of a whole, inactivated influenza (H5N1) vaccine.

PubMed

Tada, Yoshikazu

2008-11-01

Effective vaccines against the highly pathogenic influenza A/H5N1 virus are being developed worldwide. In Japan, two adjuvanted, inactivated, whole-virion influenza vaccines were recently developed and licensed as mock-up, pre-pandemic vaccine formulations by the Ministry of Health and Labor Welfare of Japan. During the vaccine design and development process, various obstacles were overcome and, in this report, we introduce the non clinical production, immunogenicity data in human and development process that was associated with egg-derived adjuvanted, inactivated, whole-virion influenza A (H5N1) vaccine. Pilot lots of H5N1 vaccine were produced using the avirulent H5N1 reference strain A/Vietnam/1194/2004 (H5N1) NIBRG-14 and administered following adsorption with aluminum hydroxide as an adjuvant. Quality control and formulation stability tests were performed before clinical trials were initiated (phase I-III). The research foundation for microbial diseases of Osaka University (BIKEN) carried out vaccine production, quality control, stability testing and the phase I clinical trial in addition to overseeing the licensing of this vaccine. Mitsubishi Chemical Safety Institute Ltd. carried out the non clinical pharmacological toxicity and safety studies and the Japanese medical association carried out the phase II/III trials. Phase I-III trials took place in 2006. The production processes were well controlled by established tests and validations. Vaccine quality was confirmed by quality control, stability and pre-clinical tests, and the vaccine was approved as a mock-up, pre-pandemic vaccine by the Ministry of Health and Labor Welfare of Japan. Numerous safety and efficacy procedures were carried out prior to the approval of the described vaccine formulation. Some of these procedures were of particular importance e.g., vaccine development, validation, and quality control tests that included strict monitoring of the hemagglutinin (HA) content of the vaccine formulations. Improving vaccine productivity, shortening the production period and improving antigen yield of the avirulent vaccine strains were also considered important vaccine development criteria.

Efficacy and safety of Suanzaoren decoction for primary insomnia: a systematic review of randomized controlled trials

PubMed Central

2013-01-01

Background Insomnia is a widespread human health problem, but there currently are the limitations of conventional therapies available. Suanzaoren decoction (SZRD) is a well known classic Chinese herbal prescription for insomnia and has been treating people’s insomnia for more than thousand years. The objective of this study was to evaluate the efficacy and safety of SZRD for insomnia. Methods A systematic literature search was performed for 6 databases up to July of 2012 to identify randomized control trials (RCTs) involving SZRD for insomniac patients. The methodological quality of RCTs was assessed independently using the Cochrane Handbook for Systematic Reviews of Interventions. Results Twelve RCTs with total of 1376 adult participants were identified. The methodological quality of all included trials are no more than 3/8 score. Majority of the RCTs concluded that SZRD was more significantly effective than benzodiazepines for treating insomnia. Despite these positive outcomes, there were many methodological shortcomings in the studies reviewed, including insufficient information about randomization generation and absence of allocation concealment, lack of blinding and no placebo control, absence of intention-to-treat analysis and lack of follow-ups, selective publishing and reporting, and small number of sample sizes. A number of clinical heterogeneity such as diagnosis, intervention, control, and outcome measures were also reviewed. Only 3 trials reported adverse events, whereas the other 9 trials did not provide the safety information. Conclusions Despite the apparent reported positive findings, there is insufficient evidence to support efficacy of SZRD for insomnia due to the poor methodological quality and the small number of trials of the included studies. SZRD seems generally safe, but is insufficient evidence to make conclusions on the safety because fewer studies reported the adverse events. Further large sample-size and well-designed RCTs are needed. PMID:23336848

Recommendations for assessing water quality and safety on board merchant ships.

PubMed

Grappasonni, Iolanda; Cocchioni, Mario; Degli Angioli, Rolando; Saturnino, Andrea; Sibilio, Fabio; Scuri, Stefania; Amenta, Francesco

2013-01-01

Health and diseases on board ships may depend on water. Interventions to improve the quality of water may bring to significant benefits to health and water stores/supply and should be controlledto protect health. This paper has reviewed the main regulations for the control of water safety and qualityon board ships and presents some practical recommendations for keeping water healthy and safe in passenger and cargo merchant ships. The main international regulations and guidelines on the topic were analysed. Guidelines forWater Quality on Board Merchant Ships Including Passenger Vessels of Health Protection Agency, World Health Organisation (WHO) Guide to Ship Sanitation, WHO Guidelines for Drinking Water Quality, WHO Water Safety Plan and the United States Center for Disease Control and Prevention Vessel Sanitation Program were examined. Recommendations for passenger and, if available, for cargo ships were collected and compared. Recommended questionnaire: A questionnaire summarising the main information to collect for assessingthe enough quality of water for the purposes it should be used on board is proposed. The need of havinga crew member with water assessment duties on board, trained for performing these activities properlyis discussed. Water quality on board ships should be monitored routinely. Monitoring should be directedto chemical and microbiological parameters for identifying possible contamination sources, using specifickits by a designed crew member. More detailed periodic assessments should be under the responsibility ofspecialised personnel/laboratories and should be based on sample collection from all tanks and sites of waterdistribution. It is important to select a properly trained crew member on board for monitoring water quality.

Randomized Trial of Reducing Ambulatory Malpractice and Safety Risk: Results of the Massachusetts PROMISES Project.

PubMed

Schiff, Gordon D; Reyes Nieva, Harry; Griswold, Paula; Leydon, Nicholas; Ling, Judy; Federico, Frank; Keohane, Carol; Ellis, Bonnie R; Foskett, Cathy; Orav, E John; Yoon, Catherine; Goldmann, Don; Weissman, Joel S; Bates, David W; Biondolillo, Madeleine; Singer, Sara J

2017-08-01

Evaluate application of quality improvement approaches to key ambulatory malpractice risk and safety areas. In total, 25 small-to-medium-sized primary care practices (16 intervention; 9 control) in Massachusetts. Controlled trial of a 15-month intervention including exposure to a learning network, webinars, face-to-face meetings, and coaching by improvement advisors targeting "3+1" high-risk domains: test result, referral, and medication management plus culture/communication issues evaluated by survey and chart review tools. Chart reviews conducted at baseline and postintervention for intervention sites. Staff and patient survey data collected at baseline and postintervention for intervention and control sites. Chart reviews demonstrated significant improvements in documentation of abnormal results, patient notification, documentation of an action or treatment plan, and evidence of a completed plan (all P<0.001). Mean days between laboratory test date and evidence of completed action/treatment plan decreased by 19.4 days (P<0.001). Staff surveys showed modest but nonsignificant improvement for intervention practices relative to controls overall and for the 3 high-risk domains that were the focus of PROMISES. A consortium of stakeholders, quality improvement tools, coaches, and learning network decreased selected ambulatory safety risks often seen in malpractice claims.

Nuclear Technology Series. Course 24: Nuclear Systems and Safety.

ERIC Educational Resources Information Center

Center for Occupational Research and Development, Inc., Waco, TX.

This technical specialty course is one of thirty-five courses designed for use by two-year postsecondary institutions in five nuclear technician curriculum areas: (1) radiation protection technician, (2) nuclear instrumentation and control technician, (3) nuclear materials processing technician, (4) nuclear quality-assurance/quality-control…

Managing safety and quality through the red meat chain.

PubMed

Desmarchelier, P; Fegan, N; Smale, N; Small, A

2007-09-01

To successfully manage food safety and quality risks in meat production, a holistic approach is required. The ideal would be a fully integrated assurance system, with effective controls applied at all stages. However, the red meat industry is by nature somewhat fragmented, and a truly integrated system is not at present achievable in all but a few operations. This paper describes a variety of assurance initiatives, and explores how targeted research and development can be used to augment assurance programmes by providing underpinning knowledge, using the Australian beef and lamb industry as an example.

Thermal pasteurization of ready-to-eat foods and vegetables: Critical factors for process design and effects on quality.

PubMed

Peng, Jing; Tang, Juming; Barrett, Diane M; Sablani, Shyam S; Anderson, Nathan; Powers, Joseph R

2017-09-22

Increasing consumer desire for high quality ready-to-eat foods makes thermal pasteurization important to both food producers and researchers. To be in compliance with the Food Safety Modernization Act (FSMA), food companies seek regulatory and scientific guidelines to ensure that their products are safe. Clearly understanding the regulations for chilled or frozen foods is of fundamental importance to the design of thermal pasteurization processes for vegetables that meet food safety requirements. This article provides an overview of the current regulations and guidelines for pasteurization in the U.S. and in Europe for control of bacterial pathogens. Poorly understood viral pathogens, in terms of their survival in thermal treatments, are an increasing concern for both food safety regulators and scientists. New data on heat resistance of viruses in different foods are summarized. Food quality attributes are sensitive to thermal degradation. A review of thermal kinetics of inactivation of quality-related enzymes in vegetables and the effects of thermal pasteurization on vegetable quality is presented. The review also discusses shelf-life of thermally pasteurized vegetables.

The impact of the implementation of physician assistants in inpatient care: A multicenter matched-controlled study

PubMed Central

van Vught, Anneke J. A. H.; Peters, Yvonne A. S.; Meermans, Geert; Peute, Joseph G. M.; Postma, Cornelis. T.; Smit, P. Casper; Verdaasdonk, Emiel; de Vries Reilingh, Tammo S.; Wensing, Michel; Laurant, Miranda G. H.

2017-01-01

Background Medical care for admitted patients in hospitals is increasingly reallocated to physician assistants (PAs). There is limited evidence about the consequences for the quality and safety of care. This study aimed to determine the effects of substitution of inpatient care from medical doctors (MDs) to PAs on patients’ length of stay (LOS), quality and safety of care, and patient experiences with the provided care. Methods In a multicenter matched-controlled study, the traditional model in which only MDs are employed for inpatient care (MD model) was compared with a mixed model in which besides MDs also PAs are employed (PA/MD model). Thirty-four wards were recruited across the Netherlands. Patients were followed from admission till one month after discharge. Primary outcome measure was patients’ LOS. Secondary outcomes concerned eleven indicators for quality and safety of inpatient care and patients’ experiences with the provided care. Results Data on 2,307 patients from 34 hospital wards was available. The involvement of PAs was not significantly associated with LOS (β 1.20, 95%CI 0.99–1.40, p = .062). None of the indicators for quality and safety of care were different between study arms. However, the involvement of PAs was associated with better experiences of patients (β 0.49, 95% CI 0.22–0.76, p = .001). Conclusions This study did not find differences regarding LOS and quality of care between wards on which PAs, in collaboration with MDs, provided medical care for the admitted patients, and wards on which only MDs provided medical care. Employing PAs seems to be safe and seems to lead to better patient experiences. Trial registration ClinicalTrials.gov Identifier: NCT01835444 PMID:28793317

Quality Control: (Material) Safety Data Sheets.

PubMed

Allen, Loyd V

2017-01-01

Safety Data Sheets (formerly Material Safety Data Sheets) are a system for cataloging information on chemicals, chemical compounds, and chemical mixtures and include instructions for the safe use and potential hazards associated with a particular material or product. At present, there are 16 sections of Safety Data Sheets, and these sections are discussed in this article. Two United States Pharmacopeia compounding-related chapters (<795> and <800>) refer to Safety Data Sheets, and this article provides a brief discussion on the terminology contained within those chapters. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

The quest to standardize hemodialysis care.

PubMed

Hegbrant, Jörgen; Gentile, Giorgio; Strippoli, Giovanni F M

2011-01-01

A large global dialysis provider's core activities include providing dialysis care with excellent quality, ensuring a low variability across the clinic network and ensuring strong focus on patient safety. In this article, we summarize the pertinent components of the quality assurance and safety program of the Diaverum Renal Services Group. Concerning medical performance, the key components of a successful quality program are setting treatment targets; implementing evidence-based guidelines and clinical protocols; consistently, regularly, prospectively and accurately collecting data from all clinics in the network; processing collected data to provide feedback to clinics in a timely manner, incorporating information on interclinic and intercountry variations; and revising targets, guidelines and clinical protocols based on sound scientific data. The key activities for ensuring patient safety include a standardized approach to education, i.e. a uniform education program including control of theoretical knowledge and clinical competencies; implementation of clinical policies and procedures in the organization in order to reduce variability and potential defects in clinic practice; and auditing of clinical practice on a regular basis. By applying a standardized and systematic continuous quality improvement approach throughout the entire organization, it has been possible for Diaverum to progressively improve medical performance and ensure patient safety. Copyright © 2011 S. Karger AG, Basel.

Microbiological Food Safety Surveillance in China

PubMed Central

Pei, Xiaoyan; Li, Ning; Guo, Yunchang; Liu, Xiumei; Yan, Lin; Li, Ying; Yang, Shuran; Hu, Jing; Zhu, Jianghui; Yang, Dajin

2015-01-01

Microbiological food safety surveillance is a system that collects data regarding food contamination by foodborne pathogens, parasites, viruses, and other harmful microbiological factors. It helps to understand the spectrum of food safety, timely detect food safety hazards, and provide relevant data for food safety supervision, risk assessment, and standards-setting. The study discusses the microbiological surveillance of food safety in China, and introduces the policies and history of the national microbiological surveillance system. In addition, the function and duties of different organizations and institutions are provided in this work, as well as the generation and content of the surveillance plan, quality control, database, and achievement of the microbiological surveillance of food safety in China. PMID:26343705

A Comprehensive Quality Evaluation System for Complex Herbal Medicine Using PacBio Sequencing, PCR-Denaturing Gradient Gel Electrophoresis, and Several Chemical Approaches

PubMed Central

Zheng, Xiasheng; Zhang, Peng; Liao, Baosheng; Li, Jing; Liu, Xingyun; Shi, Yuhua; Cheng, Jinle; Lai, Zhitian; Xu, Jiang; Chen, Shilin

2017-01-01

Herbal medicine is a major component of complementary and alternative medicine, contributing significantly to the health of many people and communities. Quality control of herbal medicine is crucial to ensure that it is safe and sound for use. Here, we investigated a comprehensive quality evaluation system for a classic herbal medicine, Danggui Buxue Formula, by applying genetic-based and analytical chemistry approaches to authenticate and evaluate the quality of its samples. For authenticity, we successfully applied two novel technologies, third-generation sequencing and PCR-DGGE (denaturing gradient gel electrophoresis), to analyze the ingredient composition of the tested samples. For quality evaluation, we used high performance liquid chromatography assays to determine the content of chemical markers to help estimate the dosage relationship between its two raw materials, plant roots of Huangqi and Danggui. A series of surveys were then conducted against several exogenous contaminations, aiming to further access the efficacy and safety of the samples. In conclusion, the quality evaluation system demonstrated here can potentially address the authenticity, quality, and safety of herbal medicines, thus providing novel insight for enhancing their overall quality control. Highlight: We established a comprehensive quality evaluation system for herbal medicine, by combining two genetic-based approaches third-generation sequencing and DGGE (denaturing gradient gel electrophoresis) with analytical chemistry approaches to achieve the authentication and quality connotation of the samples. PMID:28955365

A Comprehensive Quality Evaluation System for Complex Herbal Medicine Using PacBio Sequencing, PCR-Denaturing Gradient Gel Electrophoresis, and Several Chemical Approaches.

PubMed

Zheng, Xiasheng; Zhang, Peng; Liao, Baosheng; Li, Jing; Liu, Xingyun; Shi, Yuhua; Cheng, Jinle; Lai, Zhitian; Xu, Jiang; Chen, Shilin

2017-01-01

Herbal medicine is a major component of complementary and alternative medicine, contributing significantly to the health of many people and communities. Quality control of herbal medicine is crucial to ensure that it is safe and sound for use. Here, we investigated a comprehensive quality evaluation system for a classic herbal medicine, Danggui Buxue Formula, by applying genetic-based and analytical chemistry approaches to authenticate and evaluate the quality of its samples. For authenticity, we successfully applied two novel technologies, third-generation sequencing and PCR-DGGE (denaturing gradient gel electrophoresis), to analyze the ingredient composition of the tested samples. For quality evaluation, we used high performance liquid chromatography assays to determine the content of chemical markers to help estimate the dosage relationship between its two raw materials, plant roots of Huangqi and Danggui. A series of surveys were then conducted against several exogenous contaminations, aiming to further access the efficacy and safety of the samples. In conclusion, the quality evaluation system demonstrated here can potentially address the authenticity, quality, and safety of herbal medicines, thus providing novel insight for enhancing their overall quality control. Highlight : We established a comprehensive quality evaluation system for herbal medicine, by combining two genetic-based approaches third-generation sequencing and DGGE (denaturing gradient gel electrophoresis) with analytical chemistry approaches to achieve the authentication and quality connotation of the samples.

Mathematical modelling of active safety system functions as tools for development of driverless vehicles

NASA Astrophysics Data System (ADS)

Ryazantsev, V.; Mezentsev, N.; Zakharov, A.

2018-02-01

This paper is dedicated to a solution of the issue of synthesis of the vehicle longitudinal dynamics control functions (acceleration and deceleration control) based on the element base of the vehicle active safety system (ESP) - driverless vehicle development tool. This strategy helps to reduce time and complexity of integration of autonomous motion control systems (AMCS) into the vehicle architecture and allows direct control of actuators ensuring the longitudinal dynamics control, as well as reduction of time for calibration works. The “vehicle+wheel+road” longitudinal dynamics control is complicated due to the absence of the required prior information about the control object. Therefore, the control loop becomes an adaptive system, i.e. a self-adjusting monitoring system. Another difficulty is the driver’s perception of the longitudinal dynamics control process in terms of comfort. Traditionally, one doesn’t pay a lot of attention to this issue within active safety systems, and retention of vehicle steerability, controllability and stability in emergency situations are considered to be the quality criteria. This is mainly connected to its operational limits, since it is activated only in critical situations. However, implementation of the longitudinal dynamics control in the AMCS poses another challenge for the developers - providing the driver with comfortable vehicle movement during acceleration and deceleration - while the possible highest safety level in terms of the road grip is provided by the active safety system (ESP). The results of this research are: universal active safety system - AMCS interaction interface; block diagram for the vehicle longitudinal acceleration and deceleration control as one of the active safety system’s integrated functions; ideology of adaptive longitudinal dynamics control, which enables to realize the deceleration and acceleration requested by the AMCS; algorithms synthesised; analytical experiments proving the efficiency and practicability of the chosen concept.

Perspectives on Home Care Quality

PubMed Central

Kane, Rosalie A.; Kane, Robert L.; Illston, Laurel H.; Eustis, Nancy N.

1994-01-01

Home care quality assurance (QA) must consider features inherent in home care, including: multiple goals, limited provider control, and unique family roles. Successive panels of stakeholders were asked to rate the importance of selected home care outcomes. Most highly rated outcomes were freedom from exploitation, satisfaction with care, physical safety, affordability, and physical functioning. Panelists preferred outcome indicators to process and structure, and all groups emphasized “enabling” criteria. Themes highlighted included: interpersonal components of care; normalizing life for clientele; balancing quality of life with safety; developing flexible, negotiated care plans; mechanisms for accountability and case management. These themes were formulated differently according to the stakeholders' role. Providers preferred intermediate outcomes, akin to process. PMID:10140158

Quality and safety in the transitional care of the elderly (phase 2): the study protocol of a quasi-experimental intervention study for a cross-level educational programme

PubMed Central

Storm, Marianne; Groene, Oliver; Testad, Ingelin; Dyrstad, Dagrunn N; Heskestad, Randi N; Aase, Karina

2014-01-01

Introduction Transitional care and patient handover are important areas to ensure quality and safety in elderly healthcare services. Previous studies showed that healthcare professionals have little knowledge of the setting they are transferring patients to and a limited understanding of roles and functions; these constitute barriers to effective communication and shared care responsibilities across levels of care. Aim The main objective is to implement a cross-level education-based intervention programme with healthcare professionals aimed at (1) increasing professionals’ awareness and competencies about quality and safety in the transitional care of the elderly; (2) creating a discussion platform for knowledge exchange and learning across levels and units of care and (3) improving patient safety culture, in particular, in transitional care. Methods and analysis A quasi-experimental control group study design with an intervention group and a control group; this includes a pretest, post-test and 1-year follow-up test assessment of patient safety culture. Qualitative data will be collected during the intervention programme and between the measurements. The study design will be beneficial for addressing the effects of the cross-level educational intervention programme on reports of patient safety culture and for addressing the feasibility of the intervention measures. Ethics and dissemination The study has been approved by the Regional Committees for Medical and Health Research Ethics in Norway, Ref. No. 2011/1978. The study is based on informed written consent; informants can withdraw from the study at any point in time. The results will be disseminated at research conferences, in peer review journals and through public presentations outside the scientific community. PMID:25082425

Structured nursing communication on interdisciplinary acute care teams improves perceptions of safety, efficiency, understanding of care plan and teamwork as well as job satisfaction.

PubMed

Gausvik, Christian; Lautar, Ashley; Miller, Lisa; Pallerla, Harini; Schlaudecker, Jeffrey

2015-01-01

Efficient, accurate, and timely communication is required for quality health care and is strongly linked to health care staff job satisfaction. Developing ways to improve communication is key to increasing quality of care, and interdisciplinary care teams allow for improved communication among health care professionals. This study examines the patient- and family-centered use of structured interdisciplinary bedside rounds (SIBR) on an acute care for the elderly (ACE) unit in a 555-bed metropolitan community hospital. This mixed methods study surveyed 24 nurses, therapists, patient care assistants, and social workers to measure perceptions of teamwork, communication, understanding of the plan for the day, safety, efficiency, and job satisfaction. A similar survey was administered to a control group of 38 of the same staff categories on different units in the same hospital. The control group units utilized traditional physician-centric rounding. Significant differences were found in each category between the SIBR staff on the ACE unit and the control staff. Nurse job satisfaction is an important marker of retention and recruitment, and improved communication may be an important aspect of increasing this satisfaction. Furthermore, improved communication is key to maintaining a safe hospital environment with quality patient care. Interdisciplinary team rounds that take place at the bedside improve both nursing satisfaction and related communication markers of quality and safety, and may help to achieve higher nurse retention and safer patient care. These results point to the interconnectedness and dual benefit to both job satisfaction and patient quality of care that can come from enhancements to team communication.

IEC 61511 and the capital project process--a protective management system approach.

PubMed

Summers, Angela E

2006-03-17

This year, the process industry has reached an important milestone in process safety-the acceptance of an internationally recognized standard for safety instrumented systems (SIS). This standard, IEC 61511, documents good engineering practice for the assessment, design, operation, maintenance, and management of SISs. The foundation of the standard is established by several requirements in Part 1, Clauses 5-7, which cover the development of a management system aimed at ensuring that functional safety is achieved. The management system includes a quality assurance process for the entire SIS lifecycle, requiring the development of procedures, identification of resources and acquisition of tools. For maximum benefit, the deliverables and quality control checks required by the standard should be integrated into the capital project process, addressing safety, environmental, plant productivity, and asset protection. Industry has become inundated with a multitude of programs focusing on safety, quality, and cost performance. This paper introduces a protective management system, which builds upon the work process identified in IEC 61511. Typical capital project phases are integrated with the management system to yield one comprehensive program to efficiently manage process risk. Finally, the paper highlights areas where internal practices or guidelines should be developed to improve program performance and cost effectiveness.

Quality Control of Injection Molded Eyewear by Non-Contact Deflectometry

NASA Astrophysics Data System (ADS)

Speck, A.; Zelzer, B.; Langenbucher, A.; Eppig, T.

2014-07-01

Occupational eye wear such as safety spectacles are manufactured by injection molding techniques. Testing of the assembled safety spectacle lenses in transmission is state of the art, but there is a lack of surface measurement systems for occupational safety lenses. The purpose of this work was to validate a deflectometric setup for topography measurement, detection of defects and visualization of the polishing quality, e.g. casting indentations or impressions, for the production process of safety spectacles. The setup is based on a customized stereo phase measuring deflectometer (PMD), equipped with 3 cameras with f'1,2 = 16 mm and f'3 = 8.5 mm and a specified measurement uncertainty of ± 3 μm. Sixteen plastic lenses and 8 corresponding injection molds from 4 parallel cavities were used for validation of the deflectometer. For comparison an interferometric method and a reference standard (< λ/10 super polished) was used. The accuracy and bias with a spherical safety spectacle sample was below 1 μm, according to DIN ISO 5725-2.2002-12. The repeatability was 2.1 μm and 35.7 μm for a blind radius fit. In conclusion, the PMD technique is an appropriate tool for characterizing occupational safety spectacle and injections mold surfaces. With the presented setup we were able to quantify the surface quality. This can be useful and may optimize the quality of the end product, in addition to standardized measuring systems in transmission.

The History of Infant Formula: Quality, Safety, and Standard Methods.

PubMed

Wargo, Wayne F

2016-01-01

Food-related laws and regulations have existed since ancient times. Egyptian scrolls prescribed the labeling needed for certain foods. In ancient Athens, beer and wines were inspected for purity and soundness, and the Romans had a well-organized state food control system to protect consumers from fraud or bad produce. In Europe during the Middle Ages, individual countries passed laws concerning the quality and safety of eggs, sausages, cheese, beer, wine, and bread; some of these laws still exist today. But more modern dietary guidelines and food regulations have their origins in the latter half of the 19th century when the first general food laws were adopted and basic food control systems were implemented to monitor compliance. Around this time, science and food chemistry began to provide the tools to determine "purity" of food based primarily on chemical composition and to determine whether it had been adulterated in any way. Since the key chemical components of mammalian milk were first understood, infant formulas have steadily advanced in complexity as manufacturers attempt to close the compositional gap with human breast milk. To verify these compositional innovations and ensure product quality and safety, infant formula has become one of the most regulated foods in the world. The present paper examines the historical development of nutritional alternatives to breastfeeding, focusing on efforts undertaken to ensure the quality and safety from antiquity to present day. The impact of commercial infant formulas on global regulations is addressed, along with the resulting need for harmonized, fit-for-purpose, voluntary consensus standard methods.

18 CFR 806.2 - Purposes.

Code of Federal Regulations, 2010 CFR

2010-04-01

... the purposes of the compact and include, but are not limited to: (1) The promotion of interstate... health, safety and welfare; stream quality control; economic development; protection of fisheries and...

Improvement of microbiological safety and sensorial quality of pork jerky by electron beam irradiation and by addition of onion peel extract and barbecue flavor

NASA Astrophysics Data System (ADS)

Kim, Hyun-Joo; Jung, Samooel; Yong, Hae In; Bae, Young Sik; Kang, Suk Nam; Kim, Il Suk; Jo, Cheorun

2014-05-01

The combined effects of electron-beam (EB) irradiation and addition of onion peel (OP) extract and barbecue flavor (BF) on inactivation of foodborne pathogens and the quality of pork jerky was investigated. Prepared pork jerky samples were irradiated (0, 1, 2, and 4 kGy) and stored for 2 month at 25 °C. The D10 values of Listeria monocytogenes, Escherichia coli, and Salmonella typhimurium observed in the OP treated samples were 0.19, 0.18, and 0.19 kGy, whereas those in control were 0.25, 0.23, and 0.20 kGy, respectively. Irradiated samples with OP extract and BF had substantially lower total aerobic bacterial counts than the control had. Samples with added OP extract and BF had lower peroxide values than the control had. Sensory evaluation indicated that overall acceptability of treated samples was not changed up to 2 kGy. Therefore, EB irradiation, combined with OP extract and BF, has improved the microbiological safety with no negative effects on the quality of pork jerky.

Quality-assurance plan for the analysis of suspended sediment by the U.S. Geological Survey in Montana

USGS Publications Warehouse

Dodge, Kent A.; Lambing, John H.

2006-01-01

A quality-assurance plan has been developed for use by the sediment laboratory of the U.S. Geological Survey Montana Water Science Center in conducting activities related to the analysis of suspended sediment. The plan documents quality-assurance policies for sediment-laboratory certification, personnel responsibilities and training, documentation requirements, and laboratory safety. The plan also documents quality-assurance procedures related to laboratory equipment and supplies, sample management, sample analysis, analytical quality control, and data management.

Effect of Yoga in the Therapy of Irritable Bowel Syndrome: A Systematic Review.

PubMed

Schumann, Dania; Anheyer, Dennis; Lauche, Romy; Dobos, Gustav; Langhorst, Jost; Cramer, Holger

2016-12-01

This review aims to systematically survey the effects of yoga on symptoms of irritable bowel syndrome (IBS), pain, quality of life, mood, stress, and safety in patients with IBS. MEDLINE/Pubmed, Scopus, the Cochrane Library, CAM-QUEST, CAMbase, and IndMED were screened through November 2015. Randomized controlled trials comparing yoga with usual care, nonpharmacologic, or pharmacologic interventions were analyzed for patients with IBS. Primary outcomes included gastrointestinal symptoms, quality of life, and pain. Anxiety, mood, and safety were defined as secondary outcomes. Risk of bias was assessed according to the Cochrane Collaboration recommendations. Six randomized controlled trials with a total of 273 patients were included in the qualitative analysis. There was evidence for a beneficial effect of a yogic intervention over conventional treatment in IBS, with significantly decreased bowel symptoms, IBS severity, and anxiety. Furthermore, there were significant improvements in quality of life, global improvement, and physical functioning after yoga compared with no treatment. Two randomized controlled trials reported safety data stating that no adverse events occurred. Overall, risk of bias of the included studies was unclear. The findings of this systematic review suggest that yoga might be a feasible and safe adjunctive treatment for people with IBS. Nevertheless, no recommendation can be made regarding yoga as a routine intervention for patients with IBS because of major flaws in study methods. More research is needed with respect to a high-quality study design and consensus in clinical outcome measurements in IBS. ClinicalTrials.gov number, NCT02721836. Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.

Real-time product attribute control to manufacture antibodies with defined N-linked glycan levels.

PubMed

Zupke, Craig; Brady, Lowell J; Slade, Peter G; Clark, Philip; Caspary, R Guy; Livingston, Brittney; Taylor, Lisa; Bigham, Kyle; Morris, Arvia E; Bailey, Robert W

2015-01-01

Pressures for cost-effective new therapies and an increased emphasis on emerging markets require technological advancements and a flexible future manufacturing network for the production of biologic medicines. The safety and efficacy of a product is crucial, and consistent product quality is an essential feature of any therapeutic manufacturing process. The active control of product quality in a typical biologic process is challenging because of measurement lags and nonlinearities present in the system. The current study uses nonlinear model predictive control to maintain a critical product quality attribute at a predetermined value during pilot scale manufacturing operations. This approach to product quality control ensures a more consistent product for patients, enables greater manufacturing efficiency, and eliminates the need for extensive process characterization by providing direct measures of critical product quality attributes for real time release of drug product. © 2015 American Institute of Chemical Engineers.

Recent developments in intelligent packaging for enhancing food quality and safety.

PubMed

Sohail, Muhammad; Sun, Da-Wen; Zhu, Zhiwei

2018-03-07

The role of packaging cannot be denied in the life cycle of any food product. Intelligent packaging is an emerging technology in the food packaging sector. Although it still needs its full emergence in the market, its importance has been proved for the maintenance of food quality and safety. The present review describes several aspects of intelligent packaging. It first highlights different tools used in intelligent packaging and elucidates the role of these packaging devices for maintaining the quality of different food items in terms of controlling microbial growth and gas concentration, and for providing convenience and easiness to its users in the form of time temperature indication. This review also discusses other intelligent packaging solutions in supply chain management of food products to control theft and counterfeiting conducts and broaden the image of the food companies in terms of branding and marketing. Overall, intelligent packaging can ensure food quality and safety in the food industry, however there are still some concerns over this emerging technology including high cost and legal aspects, and thus future work should be performed to overcome these problems for further promoting its applications in the food industry. Moreover, work should also be carried out to combine several single intelligent packaging devices into a single one, so that most of the benefits from this emerging technology can be achieved.

Patient safety--worker safety: building a culture of safety to improve healthcare worker and patient well-being.

PubMed

Yassi, Annalee; Hancock, Tina

2005-01-01

Patient safety within the Canadian healthcare system is currently a high national priority, which merits a comprehensive understanding of the underlying causes of adverse events. Not least among these is worker health and safety, which is linked to patient outcomes. Healthcare workers have a high risk of workplace injuries and more mental health problems than most other occupational groups. Many healthcare professionals feel fatigued, stressed, in pain, or at risk of illness or injury-factors they feel impede their ability to provide consistent quality care. With this background, the Occupational Health and Safety Agency for Healthcare (OHSAH) in British Columbia, jointly governed by healthcare unions and healthcare employers, launched several major initiatives to improve the healthcare workplace. These included the promotion of safe patient handling, adaptive clothing, scheduled toileting, stroke management training, measures to improve management of aggressive behaviour and, of course, infection control-all intended to improve the safety of workers, but also to improve patient safety and quality of care. Other projects also explicitly promoting physical and mental health at work, as well as patient safety are also underway. Results of the projects are at various stages of completion, but ample evidence has already been obtained to indicate that looking after the well-being of healthcare workers results in safer and better quality patient care. While more research is needed, our work to date suggests that a comprehensive systems approach to promoting a climate of safety, which includes taking into account workplace organizational factors and physical and psychological hazards for workers, is the best way to improve the healthcare workplace and thereby patient safety.

The efficacy and safety of a proposed herbal moisturising cream for dry skin and itch relief: a randomised, double-blind, placebo-controlled trial--study protocol.

PubMed

Lee, Dong-Hyo; Seo, Eun-Sung; Hong, Jin-Tae; Lee, Gang-Tai; You, Young-Kyoung; Lee, Kun-Kook; Jo, Ga-Won; Kim, Nam-Kwen

2013-11-25

Moisturisers prevent and treat dry skin. They can also protect sensitive skin, improve skin tone and texture, and mask imperfections. Herbal medicines or their extracts have been available as topical formulations and cosmetics. Arctium lappa L. (Asteraceae) has been used to treat inflammatory disorders and various skin problems. It could be a candidate herbal medicine for treating dry skin condition.This study aims to establish the efficacy and safety of a proposed herbal moisturising cream containing Arctium lappa L. seed extract, which has been approved by the Korean Ministry of Food and Drug Safety for use in cosmetics. This study is a randomised, double-blind, placebo-controlled study with two parallel groups (proposed herbal moisturising cream vs. placebo cream). We will recruit 66 healthy male and female participants, aged 20 to 65 years, who have been diagnosed with dry skin conditions. Participants will be randomly allocated to receive either the proposed herbal moisturising cream or a placebo cream for four weeks. Each participant will be examined for signs and symptoms before and after using the cream. Skin hydration, sebum (oily secretion) levels and transepidermal water loss (TEWL; constitutive loss of water from the skin surface) will be assessed. Participants will also be asked to fill out a health-related quality of life questionnaire. Safety will be assessed using blood tests, urine analysis, a pregnancy test, and the assessment of vital signs. This trial will utilise high-quality methodologies in accordance with both consolidated standards for reporting trials guidelines and the guidelines for clinical trials of cosmetics products that are aimed at expressions and advertisement approval in Korea. It will evaluate the clinical efficacy and safety of a proposed herbal moisturising cream containing Arctium lappa L. seed extract to treat dry skin conditions and provide itch relief. Moreover, we will also employ health-related quality of life questionnaires to assess changes in the quality of life. The results of this study will be used to present the evidence needed to request advertising/display allowances, in compliance with the recently amended Cosmetics Act for advertisement in Korea. Current Controlled Trials ISRCTN46216631.

Radiation Safety and Quality Assurance in North American Dental Schools.

ERIC Educational Resources Information Center

Farman, Allan G.; Hines, Vickie G.

1986-01-01

A survey of dental schools that revealed processing quality control and routine maintenance checks on x-ray generators are being carried out in a timely manner is discussed. However, methods for reducing patient exposure to radiation are not being fully implemented, and some dental students are being exposed to x-rays. (Author/MLW)

[Issues in the use of medical oxygen generator with molecular sieve].

PubMed

Xu, Junfeng; Yang, Xiaoling; Zhao, Xiaolei; Bai, Jiefang; Wang, Chaojie

2014-07-01

There are some existing problems in controlling the quality of oxygen. In order to improve quality, efficiency and safety in the use of oxygen, we presented some factors which may give rise to variations in concentration of oxygen and proposed some suggestions based on the investigation and analysis of such problems.

Patients’ perceived value of pharmacy quality measures: a mixed-methods study

PubMed Central

Shiyanbola, Olayinka O; Mort, Jane R

2015-01-01

Objective To describe patients’ perceived value and use of quality measures in evaluating and choosing community pharmacies. Design Focus group methodology was combined with a survey tool. During the focus groups, participants assessed the value of the Pharmacy Quality Alliance's quality measures in evaluating and choosing a pharmacy. Also, participants completed questionnaires rating their perceived value of quality measures in evaluating a pharmacy (1 being low value and 5 being high) or choosing a pharmacy (yes/no). Thematic analysis and descriptive statistics were used to analyse the focus groups and surveys, respectively. Setting Semistructured focus groups were conducted in a private meeting space of an urban and a rural area of a Mid-western State in the USA. Participants Thirty-four adults who filled prescription medications in community pharmacies for a chronic illness were recruited in community pharmacies, senior centres and public libraries. Results While comments indicated that all measures were important, medication safety measures (eg, drug-drug interactions) were valued more highly than others. Rating of quality measure utility in evaluating a pharmacy ranged from a mean of 4.88 (‘drug-drug interactions’) to a mean of 4.0 (‘absence of controller therapy for patients with asthma’). Patients were hesitant to use quality information in choosing a pharmacy (depending on the participant's location) but might consider if moving to a new area or having had a negative pharmacy experience. Use of select quality measures to choose a pharmacy ranged from 97.1% of participants using ‘drug-drug interactions’ (medication safety measure) to 55.9% using ‘absence of controller therapy for patients with asthma’. Conclusions The study participants valued quality measures in evaluating and selecting a community pharmacy, with medication safety measures valued highest. The participants reported that the quality measures would not typically cause a switch in pharmacy but might influence their selection in certain situations. PMID:25600253

Quality assurance for gamma knives

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

Jones, E.D.; Banks, W.W.; Fischer, L.E.

1995-09-01

This report describes and summarizes the results of a quality assurance (QA) study of the Gamma Knife, a nuclear medical device used for the gamma irradiation of intracranial lesions. Focus was on the physical aspects of QA and did not address issues that are essentially medical, such as patient selection or prescription of dose. A risk-based QA assessment approach was used. Sample programs for quality control and assurance are included. The use of the Gamma Knife was found to conform to existing standards and guidelines concerning radiation safety and quality control of external beam therapies (shielding, safety reviews, radiation surveys,more » interlock systems, exposure monitoring, good medical physics practices, etc.) and to be compliant with NRC teletherapy regulations. There are, however, current practices for the Gamma Knife not covered by existing, formalized regulations, standards, or guidelines. These practices have been adopted by Gamma Knife users and continue to be developed with further experience. Some of these have appeared in publications or presentations and are slowly finding their way into recommendations of professional organizations.« less

Quality transitivity and traceability system of herbal medicine products based on quality markers.

PubMed

Liu, Changxiao; Guo, De-An; Liu, Liang

2018-05-15

Due to a variety of factors to affect the herb quality, the existing quality management model is unable to evaluate the process control. The development of the concept of "quality marker" (Q-marker) lays basis for establishing an independent process quality control system for herbal products. To ensure the highest degree of safety, effectiveness and quality process control of herbal products, it is aimed to establish a quality transitivity and traceability system of quality and process control from raw materials to finished herbal products. Based on the key issues and challenges of quality assessment, the current status of quality and process controls from raw materials to herbal medicinal products listed in Pharmacopoeia were analyzed and the research models including discovery and identification of Q-markers, analysis and quality management of risk evaluation were designed. Authors introduced a few new technologies and methodologies, such as DNA barcoding, chromatographic technologies, fingerprint analysis, chemical markers, bio-responses, risk management and solution for quality process control. The quality and process control models for herbal medicinal products were proposed and the transitivity and traceability system from raw materials to the finished products was constructed to improve the herbal quality from the entire supply and production chain. The transitivity and traceability system has been established based on quality markers, especially on how to control the production process under Good Engineering Practices, as well as to implement the risk management for quality and process control in herbal medicine production. Copyright © 2018 Elsevier GmbH. All rights reserved.

Dynamics and controls in maglev systems

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

Cai, Y.; Chen, S.S.; Rote, D.M.

1992-09-01

The dynamic response of magnetically levitated (maglev) ground transportation systems has important consequences for safety and ride quality, guideway design, and system costs. Ride quality is determined by vehicle response and by environmental factors such as humidity and noise. The dynamic response of the vehicles is the key element in determining ride quality, and vehicle stability is an important safety-related element. To design a proper guideway that provides acceptable ride quality in the stable region, vehicle dynamics must be understood. Furthermore the trade-off between guideway smoothness and the levitation and control systems must be considered if maglev systems are tomore » be economically feasible. The link between the guideway and the other maglev components is vehicle dynamics. For a commercial maglev system, vehicle dynamics must be analyzed and tested in detail. In this study, the role of dynamics and controls in maglev vehicle/guideway interactions is discussed, and the literature on modeling the dynamic interactions of vehicle/guideway and suspension controls for ground vehicles is reviewed. Particular emphasis is placed on modeling vehicle/guideway interactions and response characteristics of maglev systems for a multicar, multiload vehicle traveling on a single- or doublespan flexible guideway, including coupling effects of vehicle/guideway, comparison of concentrated and distributed loads, and ride comfort. Different control-law designs are introduced into vehicle suspensions when a simple two-degree-of-freedom vehicle model is applied. Active and semiactive control designs for primary and secondary suspensions do improve the response of vehicle and provide acceptable ride comfort. Finally, future research associated with dynamics and controls of vehicle/guideway systems is identified.« less

Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS).

PubMed

Ware, Mark A; Wang, Tongtong; Shapiro, Stan; Collet, Jean-Paul

2015-12-01

Cannabis is widely used as a self-management strategy by patients with a wide range of symptoms and diseases including chronic non-cancer pain. The safety of cannabis use for medical purposes has not been systematically evaluated. We conducted a prospective cohort study to describe safety issues among individuals with chronic non-cancer pain. A standardized herbal cannabis product (12.5% tetrahydrocannabinol) was dispensed to eligible individuals for a 1-year period; controls were individuals with chronic pain from the same clinics who were not cannabis users. The primary outcome consisted of serious adverse events and non-serious adverse events. Secondary safety outcomes included pulmonary and neurocognitive function and standard hematology, biochemistry, renal, liver, and endocrine function. Secondary efficacy parameters included pain and other symptoms, mood, and quality of life. Two hundred and fifteen individuals with chronic pain were recruited to the cannabis group (141 current users and 58 ex-users) and 216 controls (chronic pain but no current cannabis use) from 7 clinics across Canada. The median daily cannabis dose was 2.5 g/d. There was no difference in risk of serious adverse events (adjusted incidence rate ratio = 1.08, 95% confidence interval = .57-2.04) between groups. Medical cannabis users were at increased risk of non-serious adverse events (adjusted incidence rate ratio = 1.73, 95% confidence interval = 1.41-2.13); most were mild to moderate. There were no differences in secondary safety assessments. Quality-controlled herbal cannabis, when used by patients with experience of cannabis use as part of a monitored treatment program over 1 year, appears to have a reasonable safety profile. Longer-term monitoring for functional outcomes is needed. The study was registered with www.controlled-trials.com (ISRCTN19449752). This study evaluated the safety of cannabis use by patients with chronic pain over 1 year. The study found that there was a higher rate of adverse events among cannabis users compared with controls but not for serious adverse events at an average dose of 2.5 g herbal cannabis per day. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

An investigation of safety climate in OHSAS 18001-certified and non-certified organizations.

PubMed

Ghahramani, Abolfazl

2016-09-01

Many organizations worldwide have implemented Occupational Health and Safety Assessment Series (OHSAS) 18001 in their premises because of the assumed positive effects of this standard on safety. Few studies have analyzed the effect of the safety climate in OHSAS 18001-certified organizations. This case-control study used a new safety climate questionnaire to evaluate three OHSAS 18001-certified and three non-certified manufacturing companies in Iran. Hierarchical regression indicated that the safety climate was influenced by OHSAS implementation and by safety training. Employees who received safety training had better perceptions of the safety climate and its dimensions than other respondents within the certified companies. This study found that the implementation of OHSAS 18001 does not guarantee improvement of the safety climate. This study also emphasizes the need for high-quality safety training for employees of the certified companies to improve the safety climate.

Total Quality Management Implementation: Selected Readings

DTIC Science & Technology

1989-04-01

October 1986; Kaoru Ishikawa , Watj is Total Quality Control? The Japanese Way (Englewood Cliffs, NJ.r Prentice Hall, Inc. 1985), pp. 59-71 and chapter 7...and teachings of Dr. Kaoru Ishikawa and Prcfess:- Yoshikazu Tsuda. In their presentations I find ideas which conflict with current belie’s in t- s cou...responsible for S. Kaoru Ishikawa . 147iat is Total Quahn Control’ Th, Japar,,I the safety of all passengers and their belongings. w. (Englewood Hills. NJ

Analysis of medical screening and surveillance in 21 Occupational Safety and Health Administration standards: support for a generic medical surveillance standard.

PubMed

Silverstein, M

1994-09-01

Twenty-one Occupational Safety and Health Act (OSHA) standards were identified which contain medical service provisions intended to help in the identification and control of harmful health effects of workplace exposures. The utility and effectiveness of these provisions have not previously been evaluated. All 21 standards were reviewed and assigned numerical scores for each of 24 potential medical program elements. Several of these elements were combined to calculate Quality Control, Screening Utility, and Surveillance Utility scores for each standard. Total scores varied greatly, suggesting a lack of consistency and uniformity which was even more obvious when the actual regulatory language was examined. The mean Quality score was only 26% of potential points. Seventeen of 21 standards received less than half the total possible Quality score. When arrayed on a two by two matrix only two standards scored above 50% for both Screening and Surveillance Utility. It was concluded that the medical service provisions in OSHA standards are lacking in consistency and coherence. Two major shortcomings are the lack of quality control elements and the absence of surveillance features which would permit medical program results to be utilized for prevention activities including the identification and control of workplace hazards. A generic occupational medical surveillance standard could address these current weaknesses. Elements of such a generic standard are proposed.

WHO Working Group on revision of the Manual of Laboratory Methods for Testing DTP Vaccines-Report of two meetings held on 20-21 July 2006 and 28-30 March 2007, Geneva, Switzerland.

PubMed

Corbel, Michael J; Das, Rose Gaines; Lei, Dianliang; Xing, Dorothy K L; Horiuchi, Yoshinobu; Dobbelaer, Roland

2008-04-07

This report reflects the discussion and conclusions of a WHO group of experts from National Regulatory Authorities (NRAs), National Control Laboratories (NCLs), vaccine industries and other relevant institutions involved in standardization and control of diphtheria, tetanus and pertussis vaccines (DTP), held on 20-21 July 2006 and 28-30 March 2007, in Geneva Switzerland for the revision of WHO Manual for quality control of DTP vaccines. Taking into account recent developments and standardization in quality control methods and the revision of WHO recommendations for D, T, P vaccines, and a need for updating the manual has been recognized. In these two meetings the current situation of quality control methods in terms of potency, safety and identity tests for DTP vaccines and statistical analysis of data were reviewed. Based on the WHO recommendations and recent validation of testing methods, the content of current manual were reviewed and discussed. The group agreed that the principles to be observed in selecting methods included identifying those critical for assuring safety, efficacy and quality and which were consistent with WHO recommendations/requirements. Methods that were well recognized but not yet included in current Recommendations should be taken into account. These would include in vivo and/or in vitro methods for determining potency, safety testing and identity. The statistical analysis of the data should be revised and updated. It was noted that the mouse based assays for toxoid potency were still quite widely used and it was desirable to establish appropriate standards for these to enable the results to be related to the standard guinea pig assays. The working group was met again to review the first drafts and to input further suggestions or amendments to the contributions of the drafting groups. The revised manual was to be finalized and published by WHO.

[Study thought of pharmaceutical preparations quality standards by dynamic quality control technology].

PubMed

Yu, Dan-Hong; Mao, Chen-Mei; Lv, Cheng-Zhe; Jin, Hui-Zhen; Yao, Xin; Jia, Xiao-Bin

2014-07-01

Pharmaceutical preparations, particularly as a "secret recipe" of traditional Chinese medicine in medical institutions, are the product of China's medical and health industry, and they are also an important means of competing of different medical institutions. Although pharmaceutical preparations have advantages and characteristics than institutes for drug and pharmaceutical companies, the quality standards of pharmaceutical preparations in medical institutions has not reached the desired level over the years. As we all know, the quality of pharmaceutical preparations is important to ensure the efficacy, especially under the environment of people pay more sttention on drug safety and effectiveness and contry increase emphasis on the stste of pharmaceutical preparations. In view of this, we will improve the grade, stability, and clinical efficacy of pharmaceutical preparations by the advanced equipment, testing instruments and the process dynamic quality control technology. Finally, we hope we can provide new ideas for the quality control of pharmaceutical preparations.

Implementing Software Safety in the NASA Environment

NASA Technical Reports Server (NTRS)

Wetherholt, Martha S.; Radley, Charles F.

1994-01-01

Until recently, NASA did not consider allowing computers total control of flight systems. Human operators, via hardware, have constituted the ultimate safety control. In an attempt to reduce costs, NASA has come to rely more and more heavily on computers and software to control space missions. (For example. software is now planned to control most of the operational functions of the International Space Station.) Thus the need for systematic software safety programs has become crucial for mission success. Concurrent engineering principles dictate that safety should be designed into software up front, not tested into the software after the fact. 'Cost of Quality' studies have statistics and metrics to prove the value of building quality and safety into the development cycle. Unfortunately, most software engineers are not familiar with designing for safety, and most safety engineers are not software experts. Software written to specifications which have not been safety analyzed is a major source of computer related accidents. Safer software is achieved step by step throughout the system and software life cycle. It is a process that includes requirements definition, hazard analyses, formal software inspections, safety analyses, testing, and maintenance. The greatest emphasis is placed on clearly and completely defining system and software requirements, including safety and reliability requirements. Unfortunately, development and review of requirements are the weakest link in the process. While some of the more academic methods, e.g. mathematical models, may help bring about safer software, this paper proposes the use of currently approved software methodologies, and sound software and assurance practices to show how, to a large degree, safety can be designed into software from the start. NASA's approach today is to first conduct a preliminary system hazard analysis (PHA) during the concept and planning phase of a project. This determines the overall hazard potential of the system to be built. Shortly thereafter, as the system requirements are being defined, the second iteration of hazard analyses takes place, the systems hazard analysis (SHA). During the systems requirements phase, decisions are made as to what functions of the system will be the responsibility of software. This is the most critical time to affect the safety of the software. From this point, software safety analyses as well as software engineering practices are the main focus for assuring safe software. While many of the steps proposed in this paper seem like just sound engineering practices, they are the best technical and most cost effective means to assure safe software within a safe system.

[The Contribution of GMP-grade Hospital Preparation to Translational Research].

PubMed

Yonezawa, Atsushi; Kajiwara, Moto; Minami, Ikuko; Omura, Tomohiro; Nakagawa, Shunsaku; Matsubara, Kazuo

2015-01-01

Translational research is important for applying the outcomes of basic research studies to practical medical treatments. In exploratory early-phase clinical trials for an innovative therapy, researchers should generally manufacture investigational agents by themselves. To provide investigational agents with safety and high quality in clinical studies, appropriate production management and quality control are essential. In the Department of Pharmacy of Kyoto University Hospital, a manufacturing facility for sterile drugs was established, independent of existing manufacturing facilities. Manuals on production management and quality control were developed according to Good Manufacturing Practices (GMP) for Investigational New Drugs (INDs). Advanced clinical research has been carried out using investigational agents manufactured in our facility. These achievements contribute to both the safety of patients and the reliability of clinical studies. In addition, we are able to do licensing-out of our technique for the manufacture of investigational drugs. In this symposium, we will introduce our GMP grade manufacturing facility for sterile drugs and discuss the role of GMP grade hospital preparation in translational research.

Performance Measurement and Target-Setting in California's Safety Net Health Systems.

PubMed

Hemmat, Shirin; Schillinger, Dean; Lyles, Courtney; Ackerman, Sara; Gourley, Gato; Vittinghoff, Eric; Handley, Margaret; Sarkar, Urmimala

Health policies encourage implementing quality measurement with performance targets. The 2010-2015 California Medicaid waiver mandated quality measurement and reporting. In 2013, California safety net hospitals participating in the waiver set a voluntary performance target (the 90th percentile for Medicare preferred provider organization plans) for mammography screening and cholesterol control in diabetes. They did not reach the target, and the difference-in-differences analysis suggested that there was no difference for mammography ( P = .39) and low-density lipoprotein control ( P = .11) performance compared to measures for which no statewide quality improvement initiative existed. California's Medicaid waiver was associated with improved performance on a number of metrics, but this performance was not attributable to target setting on specific health conditions. Performance may have improved because of secular trends or systems improvements related to waiver funding. Relying on condition-specific targets to measure performance may underestimate improvements and disadvantage certain health systems. Achieving ambitious targets likely requires sustained fiscal, management, and workforce investments.

New & Special Grad School Programs.

ERIC Educational Resources Information Center

Ross, Steven S.

1988-01-01

Discusses some special Master of Science in engineering (MS) programs including manufacturing and quality control, safety engineering, transportation engineering, and computer related areas. Gives a table showing MS degrees, institutions, and faculty. (YP)

[Quality process control system of Chinese medicine preparation based on "holistic view"].

PubMed

Wang, Ya-Qi; Jiao, Jiao-Jiao; Wu, Zhen-Feng; Zheng, Qin; Yang, Ming

2018-01-01

"High quality, safety and effectiveness" are the primary principles for the pharmaceutical research and development process in China. The quality of products relies not only on the inspection method, but also on the design and development, process control and standardized management. The quality depends on the process control level. In this paper, the history and current development of quality control of traditional Chinese medicine (TCM) preparations are reviewed systematically. Based on the development model of international drug quality control and the misunderstanding of quality control of TCM preparations, the reasons for impacting the homogeneity of TCM preparations are analyzed and summarized. According to TCM characteristics, efforts were made to control the diversity of TCM, make "unstable" TCM into "stable" Chinese patent medicines, put forward the concepts of "holistic view" and "QbD (quality by design)", so as to create the "holistic, modular, data, standardized" model as the core of TCM preparation quality process control model. Scientific studies shall conform to the actual production of TCM preparations, and be conducive to supporting advanced equipment and technology upgrade, thoroughly applying the scientific research achievements in Chinese patent medicines, and promoting the cluster application and transformation application of TCM pharmaceutical technology, so as to improve the quality and effectiveness of the TCM industry and realize the green development. Copyright© by the Chinese Pharmaceutical Association.

Double-quality control reveals high-level toxicity in gloves used for operator protection in assisted reproductive technology.

PubMed

Lierman, Sylvie; De Sutter, Petra; Dhont, Marc; Van der Elst, Josiane

2007-10-01

To submit different glove brands to double-quality control tests using mouse embryo assay (MEA) and the human sperm motility assay (HuSMA). Operator protection against infectious body fluid contamination is a safety issue in assisted reproductive technology (ART). When using gloves in the ART laboratory, toxic substances can be transmitted to culture media, even during brief contact. Quality control study of gloves in ART. University hospital-based infertility center. Seven- to 8-week-old female B6D2F1 hybrid mice. We tested two surgical, two cleanroom, and six examination glove brands. Only gloves brands that passed both HuSMA and MEA were submitted to further QC using zona-free and/or cryopreserved MEA. Sperm motility index, two-cell and blastocyst development, blastocyst total cell number. Quality control by MEA and HuSMA identified two glove brands to be nontoxic. Our study shows that gloves used in ART can be toxic and should be tested as part of an ongoing quality control program.

Sigma Metrics Across the Total Testing Process.

PubMed

Charuruks, Navapun

2017-03-01

Laboratory quality control has been developed for several decades to ensure patients' safety, from a statistical quality control focus on the analytical phase to total laboratory processes. The sigma concept provides a convenient way to quantify the number of errors in extra-analytical and analytical phases through the defect per million and sigma metric equation. Participation in a sigma verification program can be a convenient way to monitor analytical performance continuous quality improvement. Improvement of sigma-scale performance has been shown from our data. New tools and techniques for integration are needed. Copyright © 2016 Elsevier Inc. All rights reserved.

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.

Improving food safety within the dairy chain: an application of conjoint analysis.

PubMed

Valeeva, N I; Meuwissen, M P M; Lansink, A G J M Oude; Huirne, R B M

2005-04-01

This study determined the relative importance of attributes of food safety improvement in the production chain of fluid pasteurized milk. The chain was divided into 4 blocks: "feed" (compound feed production and its transport), "farm" (dairy farm), "dairy processing" (transport and processing of raw milk, delivery of pasteurized milk), and "consumer" (retailer/catering establishment and pasteurized milk consumption). The concept of food safety improvement focused on 2 main groups of hazards: chemical (antibiotics and dioxin) and microbiological (Salmonella, Escherichia coli, Mycobacterium paratuberculosis, and Staphylococcus aureus). Adaptive conjoint analysis was used to investigate food safety experts' perceptions of the attributes' importance. Preference data from individual experts (n = 24) on 101 attributes along the chain were collected in a computer-interactive mode. Experts perceived the attributes from the "feed" and "farm" blocks as being more vital for controlling the chemical hazards; whereas the attributes from the "farm" and "dairy processing" were considered more vital for controlling the microbiological hazards. For the chemical hazards, "identification of treated cows" and "quality assurance system of compound feed manufacturers" were considered the most important attributes. For the microbiological hazards, these were "manure supply source" and "action in salmonellosis and M. paratuberculosis cases". The rather high importance of attributes relating to quality assurance and traceability systems of the chain participants indicates that participants look for food safety assurance from the preceding participants. This information has substantial decision-making implications for private businesses along the chain and for the government regarding the food safety improvement of fluid pasteurized milk.

30 CFR 905.816 - Performance standards-Surface mining activities.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Quality Control Act, Cal. Pub. Res. Code section 13000 et seq.; the California Water Code section 1200 et seq.; the California Air Pollution Control Laws, Cal. Health & Safety Code section 39000 et seq.; the..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE CALIFORNIA...

30 CFR 905.817 - Performance standards-Underground mining activities.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Quality Control Act, Cal. Pub. Res. Code section 13000 et seq.; the California Water Code section 1200 et seq.; the California Air Pollution Control Laws, Cal. Health & Safety Code section 39000 et seq.; the..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE CALIFORNIA...

30 CFR 905.817 - Performance standards-Underground mining activities.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Quality Control Act, Cal. Pub. Res. Code section 13000 et seq.; the California Water Code section 1200 et seq.; the California Air Pollution Control Laws, Cal. Health & Safety Code section 39000 et seq.; the..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE CALIFORNIA...

30 CFR 905.816 - Performance standards-Surface mining activities.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Quality Control Act, Cal. Pub. Res. Code section 13000 et seq.; the California Water Code section 1200 et seq.; the California Air Pollution Control Laws, Cal. Health & Safety Code section 39000 et seq.; the..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE CALIFORNIA...

30 CFR 905.816 - Performance standards-Surface mining activities.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Quality Control Act, Cal. Pub. Res. Code section 13000 et seq.; the California Water Code section 1200 et seq.; the California Air Pollution Control Laws, Cal. Health & Safety Code section 39000 et seq.; the..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE CALIFORNIA...

30 CFR 905.817 - Performance standards-Underground mining activities.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Quality Control Act, Cal. Pub. Res. Code section 13000 et seq.; the California Water Code section 1200 et seq.; the California Air Pollution Control Laws, Cal. Health & Safety Code section 39000 et seq.; the..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE CALIFORNIA...

30 CFR 905.816 - Performance standards-Surface mining activities.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Quality Control Act, Cal. Pub. Res. Code section 13000 et seq.; the California Water Code section 1200 et seq.; the California Air Pollution Control Laws, Cal. Health & Safety Code section 39000 et seq.; the..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE CALIFORNIA...

30 CFR 905.817 - Peformance standards-Underground mining activities.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Quality Control Act, Cal. Pub. Res. Code section 13000 et seq.; the California Water Code section 1200 et seq.; the California Air Pollution Control Laws, Cal. Health & Safety Code section 39000 et seq.; the..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE CALIFORNIA...

Efficacy and safety of nitric oxide fumigation for controlling codling moth in apples

USDA-ARS?s Scientific Manuscript database

Nitric oxide (NO) fumigation under ultralow oxygen (ULO) conditions was studied for its efficacy in controlling codling moth and effects on postharvest quality of apples. NO fumigation was effective against eggs and larvae of different sizes on artificial diet in 48 h treatments. Small larvae were...

Sci-Fri AM: Quality, Safety, and Professional Issues 01: CPQR Technical Quality Control Suite Development including Quality Control Workload Results

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

Malkoske, Kyle; Nielsen, Michelle; Brown, Erika

A close partnership between the Canadian Partnership for Quality Radiotherapy (CPQR) and the Canadian Organization of Medical Physicist’s (COMP) Quality Assurance and Radiation Safety Advisory Committee (QARSAC) has resulted in the development of a suite of Technical Quality Control (TQC) Guidelines for radiation treatment equipment, that outline specific performance objectives and criteria that equipment should meet in order to assure an acceptable level of radiation treatment quality. The framework includes consolidation of existing guidelines and/or literature by expert reviewers, structured stages of public review, external field-testing and ratification by COMP. The adopted framework for the development and maintenance of themore » TQCs ensures the guidelines incorporate input from the medical physics community during development, measures the workload required to perform the QC tests outlined in each TQC, and remain relevant (i.e. “living documents”) through subsequent planned reviews and updates. This presentation will show the Multi-Leaf Linear Accelerator document as an example of how feedback and cross-national work to achieve a robust guidance document. During field-testing, each technology was tested at multiple centres in a variety of clinic environments. As part of the defined feedback, workload data was captured. This lead to average time associated with testing as defined in each TQC document. As a result, for a medium-sized centre comprising 6 linear accelerators and a comprehensive brachytherapy program, we evaluate the physics workload to 1.5 full-time equivalent physicist per year to complete all QC tests listed in this suite.« less

[High-quality nursing health care environment: the patient safety perspective].

PubMed

Tu, Yu-Ching; Wang, Ruey-Hsia

2011-06-01

Patient safety is regarded as an important indicator of nursing care quality, and nurses hold frontline responsibility to maintain patient safety. Many countries now face healthcare provider shortfalls, and recognize a close correlation between adequate manpower and patient safety. Many healthcare organizations work to foster positive work environments in order to improve health service quality. The active participation and "buy in" of nurses, patients and policymakers are critical to maximize healthcare environment quality and improve patient safety. This article adopts Donabedian's theoretical "Structure-Process-Outcome" model of quality (Donabedian, 1988) and presumes all high-quality healthcare environment indicators to be linked to patient safety. In addition to raising public awareness regarding the influence of healthcare environment quality on patient safety, this research suggests certain indicators for tracking and assessing healthcare environment quality. Future research may design an empirical study based on these indicators to help further enhance healthcare environment quality and the professional development of nurses.

Genome sequence of the thermotolerant foodborne pathogen Salmonella enterica serovar Senftenberg ATCC 43845 and phylogenetic analysis of Loci encoding increased protein quality control mechanisms

USDA-ARS?s Scientific Manuscript database

Salmonella enterica subsp. enterica bacteria are important foodborne pathogens with major economic impact. Some isolates exhibit increased heat tolerance, a concern for food safety. Analysis of a finished-quality genome sequence of an isolate commonly used in heat resistance studies, S. enterica sub...

Devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel.

PubMed

Reddy, Viraj K; Lavoie, Marie-Claude; Verbeek, Jos H; Pahwa, Manisha

2017-11-14

Percutaneous exposure injuries from devices used for blood collection or for injections expose healthcare workers to the risk of blood borne infections such as hepatitis B and C, and human immunodeficiency virus (HIV). Safety features such as shields or retractable needles can possibly contribute to the prevention of these injuries and it is important to evaluate their effectiveness. To determine the benefits and harms of safety medical devices aiming to prevent percutaneous exposure injuries caused by needles in healthcare personnel versus no intervention or alternative interventions. We searched CENTRAL, MEDLINE, EMBASE, NHSEED, Science Citation Index Expanded, CINAHL, Nioshtic, CISdoc and PsycINFO (until 11 November 2016). We included randomised controlled trials (RCT), controlled before and after studies (CBA) and interrupted time-series (ITS) designs of the effect of safety engineered medical devices on percutaneous exposure injuries in healthcare staff. Two of the authors independently assessed study eligibility and risk of bias and extracted data. We synthesized study results with a fixed-effect or random-effects model meta-analysis where appropriate. We included six RCTs with 1838 participants, two cluster-RCTs with 795 participants and 73,454 patient days, five CBAs with approximately 22,000 participants and eleven ITS with an average of 13.8 data points. These studies evaluated safe modifications of blood collection systems, intravenous (IV) systems, injection systems, multiple devices, sharps containers and legislation on the implementation of safe devices. We estimated the needlestick injury (NSI) rate in the control groups to be about one to five NSIs per 1000 person-years. There were only two studies from low- or middle-income countries. The risk of bias was high in 20 of 24 studies. Safe blood collection systems:We found one RCT that found a safety engineered blood gas syringe having no considerable effect on NSIs (Relative Risk (RR) 0.2, 95% Confidence Interval (95% CI) 0.01 to 4.14, 550 patients, very low quality evidence). In one ITS study, safe blood collection systems decreased NSIs immediately after the introduction (effect size (ES) -6.9, 95% CI -9.5 to -4.2) but there was no further decrease over time (ES -1.2, 95% CI -2.5 to 0.1, very low quality evidence). Another ITS study evaluated an outdated recapping shield, which we did not consider further. Safe Intravenous systemsThere was very low quality evidence in two ITS studies that NSIs were reduced with the introduction of safe IV devices, whereas one RCT and one CBA study provided very low quality evidence of no effect. However, there was moderate quality evidence produced by four other RCT studies that these devices increased the number of blood splashes when the safety system had to be engaged actively (relative risk (RR) 1.6, 95% CI 1.08 to 2.36). In contrast there was low quality evidence produced by two RCTs of passive systems that showed no effect on blood splashes. Yet another RCT produced low quality evidence that a different safe active IV system also decreased the incidence of blood leakages. Safe injection devicesThere was very low quality evidence provided by one RCT and one CBA study showing that introduction of safe injection devices did not considerably change the NSI rate. One ITS study produced low quality evidence showing that the introduction of safe passive injection systems had no effect on NSI rate when compared to safe active injection systems. Multiple safe devicesThere was very low quality evidence from one CBA study and two ITS studies. According to the CBA study, the introduction of multiple safe devices resulted in a decrease in NSI,whereas the two ITS studies found no change. Safety containersOne CBA study produced very low quality evidence showing that the introduction of safety containers decreased NSI. However, two ITS studies evaluating the same intervention found inconsistent results. LegislationThere was low to moderate quality evidence in two ITS studies that introduction of legislation on the use of safety-engineered devices reduced the rate of NSIs among healthcare workers. There was also low quality evidence which showed a decrease in the trend over time for NSI rates.Twenty out of 24 studies had a high risk of bias and the lack of evidence of a beneficial effect could be due to both confounding and bias. This does not mean that these devices are not effective. For safe blood collection systems, we found very low quality evidence of inconsistent effects on NSIs. For safe passive intravenous systems, we found very low quality evidence of a decrease in NSI and a reduction in the incidence of blood leakage events but moderate quality evidence that active systems may increase exposure to blood. For safe injection needles, the introduction of multiple safety devices or the introduction of sharps containers the evidence was inconsistent or there was no clear evidence of a benefit. There was low to moderate quality evidence that introduction of legislation probably reduces NSI rates.More high-quality cluster-randomised controlled studies that include cost-effectiveness measures are needed, especially in countries where both NSIs and blood-borne infections are highly prevalent.

Safe and effective nursing shift handover with NURSEPASS: An interrupted time series.

PubMed

Smeulers, Marian; Dolman, Christine D; Atema, Danielle; van Dieren, Susan; Maaskant, Jolanda M; Vermeulen, Hester

2016-11-01

Implementation of a locally developed evidence based nursing shift handover blueprint with a bedside-safety-check to determine the effect size on quality of handover. A mixed methods design with: (1) an interrupted time series analysis to determine the effect on handover quality in six domains; (2) descriptive statistics to analyze the intercepted discrepancies by the bedside-safety-check; (3) evaluation sessions to gather experiences with the new handover process. We observed a continued trend of improvement in handover quality and a significant improvement in two domains of handover: organization/efficiency and contents. The bedside-safety-check successfully identified discrepancies on drains, intravenous medications, bandages or general condition and was highly appreciated. Use of the nursing shift handover blueprint showed promising results on effectiveness as well as on feasibility and acceptability. However, to enable long term measurement on effectiveness, evaluation with large scale interrupted times series or statistical process control is needed. Copyright © 2016 Elsevier Inc. All rights reserved.

Culture, language, and patient safety: Making the link.

PubMed

Johnstone, Megan-Jane; Kanitsaki, Olga

2006-10-01

It has been well recognized internationally that hospitals are not as safe as they should be. In order to redress this situation, health care services around the world have turned their attention to strategically implementing robust patient safety and quality care programmes to identify circumstances that put patients at risk of harm and then acting to prevent or control those risks. Despite the progress that has been made in improving hospital safety in recent years, there is emerging evidence that patients of minority cultural and language backgrounds are disproportionately at risk of experiencing preventable adverse events while in hospital compared with mainstream patient groups. One reason for this is that patient safety programmes have tended to underestimate and understate the critical relationship that exists between culture, language, and the safety and quality of care of patients from minority racial, ethno-cultural, and language backgrounds. This article suggests that the failure to recognize the critical link between culture and language (of both the providers and recipients of health care) and patient safety stands as a 'resident pathogen' within the health care system that, if not addressed, unacceptably exposes patients from minority ethno-cultural and language backgrounds to preventable adverse events in hospital contexts. It is further suggested that in order to ensure that minority as well as majority patient interests in receiving safe and quality care are properly protected, the culture-language-patient-safety link needs to be formally recognized and the vulnerabilities of patients from minority cultural and language backgrounds explicitly identified and actively addressed in patient safety systems and processes.

[New international initiatives to create systems of effective risk prediction and food safety].

PubMed

Efimochkinal, N R; Bagryantseva, E C; Dupouy, E C; Khotimchenko, S A; Permyakov, E V; Sheveleva, S A; Arnautov, O V

2016-01-01

Ensuring food safety is one of the most important problems that is directly related to health protection of the population. The problem is particularly relevant on aglobalscale because ofincreasingnumberoffood-borne diseases andimportance of the health consequence early detection. In accordance with the position of the Codex Alimentarius Commission, food safety concept also includes quality. In this case, creation of the national, supranational and international early warning systems related to the food safety, designed with the purpose to prevent or minimize risks on different stages of the food value chain in various countries, regions and climate zones specific to national nutrition and lifestyle in different groups of population, gains particular importance. The article describes the principles and working examples of international, supranational and national food safety early warning systems. Great importance is given to the hazards of microbial origin - emergent pathogens. Example of the rapid reaction to the appearance of cases, related to the melanin presence in infant formula, are presented. Analysis of the current food safety and quality control system in Russian Federation shows that main improvements are mostly related to the development of the efficient monitoring, diagnostics and rapid alert procedures forfood safety on interregional and international levels that will allow to estimate real contamination of food with the most dangerous pathogens, chemical and biological contaminants, and the development of the electronic database and scientifically proved algorithms for food safety and quality management for targeted prevention activities against existing and emerging microbiological and other etiology risks, and public health protection.

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

PubMed Central

2011-01-01

Background Adequate reporting of safety in publications of randomized controlled trials (RCTs) is a pre-requisite for accurate and comprehensive profile evaluation of conventional as well as complementary and alternative medicine (CAM) treatments. Clear and concise information on the definition, frequency, and severity of adverse events (AEs) is necessary for assessing the benefit-harm ratio of any intervention. The objectives of this study are to assess the quality of safety reporting in CAM RCTs; to explore the influence of different trial characteristics on the quality of safety reporting. Methods Survey of safety reporting in RCTs published in 2009 across 15 widely used CAM interventions identified from the Cochrane Collaboration's CAM Field specialized register of trials. Primary outcome measures, the adequacy of reporting of AEs; was defined and categorized according to the CONSORT for harms extension; the percentage of words devoted to the reporting of safety in the entire report and in the results section. Results Two-hundred and five trials were included in the review. Of these, 15% (31/205) reported that no harms were observed during the trial period. Of the remaining 174 trials reporting any safety information, only 21% (36/174) had adequate safety reporting. For all trials, the median percentage of words devoted to the reporting of safety in the results section was 2.6. Moreover, 69% (n = 141) of all trials devoted a lesser or equal percentage of words to safety compared to author affiliations. Of the predictor variables used in regression analysis, multicenter trials had more words devoted to safety in the results section than single centre trials (P = 0.045). Conclusions An evaluation of safety reporting in the reports of CAM RCTs across 15 different CAM interventions demonstrated that the reporting of harms was largely inadequate. The quality of reporting safety information in primary reports of CAM randomized trials requires improvement. PMID:21859470

A Study to Develop an Assessment Tool and Evaluate the Social Work Service Quality Assurance Plan at Walter Reed Army Medical Center, Brooke Army Medical Center, and Fitzsimons Army Medical Center

DTIC Science & Technology

1987-07-01

the plan identify methods of integration with other military services (Army Community Service, Ariny Drug and Alcohol Prevention and Control Program...home care or out-of-home care setting. 1 2 3 4 5 NA 21.2.2.4 Patient safety and infection control . 1 2 3 4 5 NA 21.2.3 Personnel who provide social...4 5 NA SO2.2.4 Patient safety and infection control . 1 2 3 4 5 NA SO.2.3 Personnel who provide social work services participate in relevant continuing

Older Adults and Food Safety

MedlinePlus

... bodies are less able to combat bacteria. For example, there is a decrease in stomach acid secretion, ... Civil Rights | No FEAR | Information Quality Complementary Content ${title} ${loading} ${title} ${loading} ibmCfg.controllers.navigation true true ...

Biocontrol strategies for Mediterranean-style fermented sausages.

PubMed

Oliveira, Márcia; Ferreira, Vânia; Magalhães, Rui; Teixeira, Paula

2018-01-01

Naturally fermented meat sausages have a long tradition in Mediterranean countries and are one of the most important groups of traditional foods consumed throughout Europe. Despite all the advances in food science and technology and increased regulatory requirements and concerns for safety and quality during the last decades, the challenge to control important foodborne pathogens in this type of meat products still persists. Simultaneously, growing consumer interest in safe, high quality and minimal processed products, with less additives/preservatives have driven the food industry and scientists in a crusade for innovative technologies to maintain the safety of these products by natural means. Biological control (biocontrol) fits well within this tendency. This review summarizes the latest achievements on biocontrol strategies applied to Mediterranean-style fermented sausages, namely: (i) bioprotective cultures; (ii) bacteriocins; and, (iii) essential oils (EOs). Copyright © 2017 Elsevier Ltd. All rights reserved.

[The system of the quality control and the safety of baby food, the prospects of its development].

PubMed

Georgieva, O V; Konovalova, L S; Kon', I Ya

In the article there is considered the substantiation of raise demands to the chemical composition of children’s food and indices of their safety, with taking into account the immaturity of metabolic and physiological processes and limitations of “depot” of nutrients in babies. Based on research results of leading experts in the field of children’s nutritiology and according to the recommendations of the Codex Alimentarius of the Commission of FAO/WHO, ESPGHAN Committee on Nutrition, the EFSA recommendations and EUDirectives there were specified requirements for the ingredient composition, content of essential components and indices of the nutritional value of substitutes for human milk and functional products for the nutrition of infants of the first year of life. There are shown stages of the development of the Russian system of hygienic requirements for baby food, and the direction of its harmonization with international and European standards, particularly for substitutes for human milk and products of dietary therapeutic and dietary preventive nutrition for babies. There are considered aspects of the introduction ofproducts and weaning food dishes into the food ration of infants. There is presented the classification ofproducts of children’s food and the assortment of each group of weaning foods. There is provided the modern legislative framework in the field of the quality and safety for infant nutrition. There was shown the difference between domestic legislation and regulatory framework of the EurAsEC Customs Union of the European countries in the field offood products safety for children older three years. There are presented proposals on the creation of the single regulatory base within the framework of the EurAsEC Customs Union for control the quality and safety of all the baby foods.

A 100-Year Review: Microbiology and safety of milk handling.

PubMed

Boor, Kathryn J; Wiedmann, Martin; Murphy, Sarah; Alcaine, Sam

2017-12-01

Microbes that may be present in milk can include pathogens, spoilage organisms, organisms that may be conditionally beneficial (e.g., lactic acid bacteria), and those that have not been linked to either beneficial or detrimental effects on product quality or human health. Although milk can contain a full range of organisms classified as microbes (i.e., bacteria, viruses, fungi, and protozoans), with few exceptions (e.g., phages that affect fermentations, fungal spoilage organisms, and, to a lesser extent, the protozoan pathogens Cryptosporidium and Giardia) dairy microbiology to date has focused predominantly on bacteria. Between 1917 and 2017, our understanding of the microbes present in milk and the tools available for studying those microbes have changed dramatically. Improved microbiological tools have enabled enhanced detection of known microbes in milk and dairy products and have facilitated better identification of pathogens and spoilage organisms that were not known or well recognized in the early 20th century. Starting before 1917, gradual introduction and refinement of pasteurization methods throughout the United States and many other parts of the world have improved the safety and quality of milk and dairy products. In parallel to pasteurization, others strategies for reducing microbial contamination throughout the dairy chain (e.g., improved dairy herd health, raw milk tests, clean-in-place technologies) also played an important role in improving microbial milk quality and safety. Despite tremendous advances in reducing microbial food safety hazards and spoilage issues, the dairy industry still faces important challenges, including but not limited to the need for improved science-based strategies for safety of raw milk cheeses, control of postprocessing contamination, and control of sporeforming pathogens and spoilage organisms. Copyright © 2017 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Aerospace Safety Advisory Panel

NASA Technical Reports Server (NTRS)

1984-01-01

An assessment of NASA's safety performance for 1983 affirms that NASA Headquarters and Center management teams continue to hold the safety of manned flight to be their prime concern, and that essential effort and resources are allocated for maintaining safety in all of the development and operational programs. Those conclusions most worthy of NASA management concentration are given along with recommendations for action concerning; product quality and utility; space shuttle main engine; landing gear; logistics and management; orbiter structural loads, landing speed, and pitch control; the shuttle processing contractor; and the safety of flight operations. It appears that much needs to be done before the Space Transportation System can achieve the reliability necessary for safe, high rate, low cost operations.

The Efficacy, Safety and Applications of Medical Hypnosis.

PubMed

Häuser, Winfried; Hagl, Maria; Schmierer, Albrecht; Hansen, Ernil

2016-04-29

The efficacy and safety of hypnotic techniques in somatic medicine, known as medical hypnosis, have not been supported to date by adequate scientific evidence. We systematically reviewed meta-analyses of randomized controlled trials (RCTs) of medical hypnosis. Relevant publications (January 2005 to June 2015) were sought in the Cochrane databases CDSR and DARE, and in PubMed. Meta-analyses involving at least 400 patients were included in the present analysis. Their methodological quality was assessed with AMSTAR (A Measurement Tool to Assess Systematic Reviews). An additional search was carried out in the CENTRAL and PubMed databases for RCTs of waking suggestion (therapeutic suggestion without formal trance induction) in somatic medicine. Out of the 391 publications retrieved, five were reports of metaanalyses that met our inclusion criteria. One of these meta-analyses was of high methodological quality; three were of moderate quality, and one was of poor quality. Hypnosis was superior to controls with respect to the reduction of pain and emotional stress during medical interventions (34 RCTs, 2597 patients) as well as the reduction of irritable bowel symptoms (8 RCTs, 464 patients). Two meta-analyses revealed no differences between hypnosis and control treatment with respect to the side effects and safety of treatment. The effect size of hypnosis on emotional stress during medical interventions was low in one meta-analysis, moderate in one, and high in one. The effect size on pain during medical interventions was low. Five RCTs indicated that waking suggestion is effective in medical procedures. Medical hypnosis is a safe and effective complementary technique for use in medical procedures and in the treatment of irritable bowel syndrome. Waking suggestions can be a component of effective doctor-patient communication in routine clinical situations.

TU-EF-BRD-04: Summing It Up: The Future of Quality and Safety Research

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

Ford, E.

Research related to quality and safety has been a staple of medical physics academic activities for a long time. From very early on, medical physicists have developed new radiation measurement equipment and analysis techniques, created ever increasingly accurate dose calculation models, and have vastly improved imaging, planning, and delivery techniques. These and other areas of interest have improved the quality and safety of radiotherapy for our patients. With the advent of TG-100, quality and safety is an area that will garner even more research interest in the future. As medical physicists pursue quality and safety research in greater numbers, itmore » is worthwhile to consider what actually constitutes research on quality and safety. For example, should the development of algorithms for real-time EPID-based in-vivo dosimetry be defined as “quality and safety” research? How about the clinical implementation of such as system? Surely the application of failure modes and effects analysis to a clinical process would be considered quality and safety research, but is this type of research that should be included in the medical physics peer-reviewed literature? The answers to such questions are of critical importance to set researchers in a direction that will provide the greatest benefit to our field and the patients we serve. The purpose of this symposium is to consider what constitutes research in the arena of quality and safety and differentiate it from other research directions. The key distinction here is developing the tool itself (e.g. algorithms for EPID dosimetry) vs. studying the impact of the tool with some quantitative metric. Only the latter would I call quality and safety research. Issues of ‘basic’ versus ‘applied’ quality and safety research will be covered as well as how the research results should be structured to provide increasing levels of support that a quality and safety intervention is effective and sustainable. Examples from existing peer-reviewed research will be used to highlight the main points. Historical, medical physicists have leveraged many areas of applied physics, engineering and biology to improve radiotherapy. Research on quality and safety is another area where physicists can have an impact. The key to further progress is to clearly define what constitutes quality and safety research for those interested in doing such research and the reviewers of that research. Learning Objectives: List several tools of quality and safety with references to peer-reviewed literature. Describe effects of mental workload on performance. Outline research in quality and safety indicators and technique analysis. Understand what quality and safety research needs to be going forward. Understand the links between cooperative group trials and quality and safety research.« less

TU-EF-BRD-01: Topics in Quality and Safety Research and Level of Evidence

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

Pawlicki, T.

Research related to quality and safety has been a staple of medical physics academic activities for a long time. From very early on, medical physicists have developed new radiation measurement equipment and analysis techniques, created ever increasingly accurate dose calculation models, and have vastly improved imaging, planning, and delivery techniques. These and other areas of interest have improved the quality and safety of radiotherapy for our patients. With the advent of TG-100, quality and safety is an area that will garner even more research interest in the future. As medical physicists pursue quality and safety research in greater numbers, itmore » is worthwhile to consider what actually constitutes research on quality and safety. For example, should the development of algorithms for real-time EPID-based in-vivo dosimetry be defined as “quality and safety” research? How about the clinical implementation of such as system? Surely the application of failure modes and effects analysis to a clinical process would be considered quality and safety research, but is this type of research that should be included in the medical physics peer-reviewed literature? The answers to such questions are of critical importance to set researchers in a direction that will provide the greatest benefit to our field and the patients we serve. The purpose of this symposium is to consider what constitutes research in the arena of quality and safety and differentiate it from other research directions. The key distinction here is developing the tool itself (e.g. algorithms for EPID dosimetry) vs. studying the impact of the tool with some quantitative metric. Only the latter would I call quality and safety research. Issues of ‘basic’ versus ‘applied’ quality and safety research will be covered as well as how the research results should be structured to provide increasing levels of support that a quality and safety intervention is effective and sustainable. Examples from existing peer-reviewed research will be used to highlight the main points. Historical, medical physicists have leveraged many areas of applied physics, engineering and biology to improve radiotherapy. Research on quality and safety is another area where physicists can have an impact. The key to further progress is to clearly define what constitutes quality and safety research for those interested in doing such research and the reviewers of that research. Learning Objectives: List several tools of quality and safety with references to peer-reviewed literature. Describe effects of mental workload on performance. Outline research in quality and safety indicators and technique analysis. Understand what quality and safety research needs to be going forward. Understand the links between cooperative group trials and quality and safety research.« less

Bilastine: new insight into antihistamine treatment.

PubMed

Ridolo, Erminia; Montagni, Marcello; Bonzano, Laura; Incorvaia, Cristoforo; Canonica, Giorgio Walter

2015-01-01

Bilastine is a new second generation H1-antihistamine recently approved for the symptomatic treatment of allergic rhinitis (AR) and chronic urticaria (CU). Bilastine epitomizes the evolution of research on antihistamines concerning both efficacy and safety. In AR treatment, a number of large controlled clinical trials documented its efficacy, as assessed by improvement of all nasal and ocular symptoms and quality of life. These outcomes show that bilastine meets current EAACI/ARIA criteria for medications used in the treatment of AR. Also in CU, the review of the literature indicates that once-daily treatment with bilastine 20 mg was effective in managing symptoms and improving patient's quality of life. Concerning safety and tolerability, the profile of bilastine is very similar to placebo and in particular the adverse effects on central nervous system are insignificant. The balance of efficacy and safety of bilastine is particularly helpful when dosages higher than standard are needed to control the symptoms, as frequently occurs in patients with urticaria, in whom antihistamines doses up to four times the standard dose may be administered.

New System of Food Control in Russia

NASA Astrophysics Data System (ADS)

Ermakova, Irina V.

Food safety is quite important for human health in all countries. Humanity has the uniform space and must take care about all parts of it. Pollution of one region leads to the same state of others regions through water, land, air, living organisms. The poor-quality or poisoned food products can pollute the territory and influence negatively on the environment. The food security is important, especially, in connection with the possibility of terrorist attacks. The Federal Service of control in sphere of protection of the rights of consumers was formed in Russia in 2004. This Service carries out the activity directly and through the territorial organizations in interaction with administrative structures in food control and inspection, namely in sanitary-epidemiological service, veterinary service, grain service, inspection of trade connections and standardization and certification. The control is carried out on the basis of laws. The law № 29-FZ concerns the quality and safety of foodstuff and how to control it. The law 134-FZ attracted the protection of the rights of legal persons and individual businessmen. The modification of the law №234-FZ about protection of the rights of consumers is connected with new food - GMOs. Great attention is paid to the safety of new food. Private companies also perform analysis of heavy metals, mycotoxins, radiation and the presence of bacteria, virus or genetically modified organisms. We would like to thank the group Pilot Study "Food chain security" for very important work concerning food safety in different countries. They help us to understand internal problems in Russia and to create the cooperation with other countries. All these steps are very important for the protection population from toxic food.

Improving teamwork: impact of structured interdisciplinary rounds on a hospitalist unit.

PubMed

O'Leary, Kevin J; Haviley, Corinne; Slade, Maureen E; Shah, Hiren M; Lee, Jungwha; Williams, Mark V

2011-02-01

Effective collaboration and teamwork is essential in providing safe and effective care. Research reveals deficiencies in teamwork on medical units involving hospitalists. The aim of this study was to assess the impact of an intervention, Structured Inter-Disciplinary Rounds (SIDR), on nurses' ratings of collaboration and teamwork. The study was a controlled trial involving an intervention and control hospitalist unit. The intervention, SIDR, combined a structured format for communication with a forum for regular interdisciplinary meetings. We asked nurses to rate the quality of communication and collaboration with hospitalists using a 5-point ordinal scale. We also assessed teamwork and safety climate using a validated instrument. Multivariable regression analyses were used to assess the impact on length of stay (LOS) and cost using both a concurrent and historic control. A total of 49 of 58 (84%) nurses completed surveys. A larger percentage of nurses rated the quality of communication and collaboration with hospitalists as high or very high on the intervention unit compared to the control unit (80% vs. 54%; P = 0.05). Nurses also rated the teamwork and safety climate significantly higher on the intervention unit (P = 0.008 and P = 0.03 for teamwork and safety climate, respectively). Multivariable analyses demonstrated no difference in the adjusted LOS and an inconsistent effect on cost. SIDR had a positive effect on nurses' ratings of collaboration and teamwork on a hospitalist unit, yet no impact on LOS and cost. Further study is required to assess the impact of SIDR on patient safety measures. Copyright © 2010 Society of Hospital Medicine.

HYGIENE PRACTICES IN URBAN RESTAURANTS AND CHALLENGES TO IMPLEMENTING FOOD SAFETY AND HAZARD ANALYSIS CRITICAL CONTROL POINTS (HACCP) PROGRAMMES IN THIKA TOWN, KENYA.

PubMed

Muinde, R K; Kiinyukia, C; Rombo, G O; Muoki, M A

2012-12-01

To determine the microbial load in food, examination of safety measures and possibility of implementing an Hazard Analysis Critical Control Points (HACCP) system. The target population for this study consisted of restaurants owners in Thika. Municipality (n = 30). Simple randomsamples of restaurantswere selected on a systematic sampling method of microbial analysis in cooked, non-cooked, raw food and water sanitation in the selected restaurants. Two hundred and ninety eight restaurants within Thika Municipality were selected. Of these, 30 were sampled for microbiological testing. From the study, 221 (74%) of the restaurants were ready to eat establishments where food was prepared early enough to hold and only 77(26%) of the total restaurants, customers made an order of food they wanted. 118(63%) of the restaurant operators/staff had knowledge on quality control on food safety measures, 24 (8%) of the restaurants applied these knowledge while 256 (86%) of the restaurants staff showed that food contains ingredients that were hazard if poorly handled. 238 (80%) of the resultants used weighing and sorting of food materials, 45 (15%) used preservation methods and the rest used dry foods as critical control points on food safety measures. The study showed that there was need for implementation of Hazard Analysis Critical Control Points (HACCP) system to enhance food safety. Knowledge of HACCP was very low with 89 (30%) of the restaurants applying some of quality measures to the food production process systems. There was contamination with Coliforms, Escherichia coli and Staphylococcus aureus microbial though at very low level. The means of Coliforms, Escherichia coli and Staphylococcus aureas microbial in sampled food were 9.7 x 103CFU/gm, 8.2 x 103 CFU/gm and 5.4 x 103 CFU/gm respectively with Coliforms taking the highest mean.

Six sigma tools for a patient safety-oriented, quality-checklist driven radiation medicine department.

PubMed

Kapur, Ajay; Potters, Louis

2012-01-01

The purpose of this work was to develop and implement six sigma practices toward the enhancement of patient safety in an electronic, quality checklist-driven, multicenter, paperless radiation medicine department. A quality checklist process map (QPM), stratified into consultation through treatment-completion stages was incorporated into an oncology information systems platform. A cross-functional quality management team conducted quality-function-deployment and define-measure-analyze-improve-control (DMAIC) six sigma exercises with a focus on patient safety. QPM procedures were Pareto-sorted in order of decreasing patient safety risk with failure mode and effects analysis (FMEA). Quantitative metrics for a grouped set of highest risk procedures were established. These included procedural delays, associated standard deviations and six sigma Z scores. Baseline performance of the QPM was established over the previous year of usage. Data-driven analysis led to simplification, standardization, and refinement of the QPM with standard deviation, slip-day reduction, and Z-score enhancement goals. A no-fly policy (NFP) for patient safety was introduced at the improve-control DMAIC phase, with a process map interlock imposed on treatment initiation in the event of FMEA-identified high-risk tasks being delayed or not completed. The NFP was introduced in a pilot phase with specific stopping rules and the same metrics used for performance assessments. A custom root-cause analysis database was deployed to monitor patient safety events. Relative to the baseline period, average slip days and standard deviations for the risk-enhanced QPM procedures improved by over threefold factors in the NFP period. The Z scores improved by approximately 20%. A trend for proactive delays instead of reactive hard stops was observed with no adverse effects of the NFP. The number of computed potential no-fly delays per month dropped from 60 to 20 over a total of 520 cases. The fraction of computed potential no-fly cases that were delayed in NFP compliance rose from 28% to 45%. Proactive delays rose to 80% of all delayed cases. For potential no-fly cases, event reporting rose from 18% to 50%, while for actually delayed cases, event reporting rose from 65% to 100%. With complex technologies, resource-compromised staff, and pressures to hasten treatment initiation, the use of the six sigma driven process interlocks may mitigate potential patient safety risks as demonstrated in this study. Copyright © 2012 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

Proteomics in food: Quality, safety, microbes, and allergens.

PubMed

Piras, Cristian; Roncada, Paola; Rodrigues, Pedro M; Bonizzi, Luigi; Soggiu, Alessio

2016-03-01

Food safety and quality and their associated risks pose a major concern worldwide regarding not only the relative economical losses but also the potential danger to consumer's health. Customer's confidence in the integrity of the food supply could be hampered by inappropriate food safety measures. A lack of measures and reliable assays to evaluate and maintain a good control of food characteristics may affect the food industry economy and shatter consumer confidence. It is imperative to create and to establish fast and reliable analytical methods that allow a good and rapid analysis of food products during the whole food chain. Proteomics can represent a powerful tool to address this issue, due to its proven excellent quantitative and qualitative drawbacks in protein analysis. This review illustrates the applications of proteomics in the past few years in food science focusing on food of animal origin with some brief hints on other types. Aim of this review is to highlight the importance of this science as a valuable tool to assess food quality and safety. Emphasis is also posed in food processing, allergies, and possible contaminants like bacteria, fungi, and other pathogens. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Annual Report to the NASA Administrator by the Aerospace Safety Advisory Panel on the Space Shuttle Program. Part 2: Summary of Information Developed in the Panel's Fact-Finding Activities

NASA Technical Reports Server (NTRS)

1977-01-01

The panel focused its attention on those areas that are considered most significant for flight success and safety. Elements required for the Approach and Landing Test Program, the Orbital Flight Test Program, and those management systems and their implementation which directly affect safety, reliability, and quality control, were investigated. Ground facilities and the training programs for the ground and flight crews were studied. Of special interest was the orbiter thermal protection subsystems.

The National Mastitis Council: A Global Organization for Mastitis Control and Milk Quality, 50 Years and Beyond.

PubMed

Middleton, John R; Saeman, Anne; Fox, Larry K; Lombard, Jason; Hogan, Joe S; Smith, K Larry

2014-12-01

The National Mastitis Council was founded in 1961 based on the desire of a forward-thinking group of individuals to bring together "all forces of organized agriculture in the United States to combat, through every practical device, the mastitis threat to the Nation's health and food safety". What started as a small organization focused on mastitis of dairy cattle in the United States has grown into a global organization for mastitis and milk quality. Over the last 50-plus years the concerted efforts of the membership have led to the synthesis and dissemination of a considerable body of knowledge regarding udder health, milk quality, and food safety which has improved dairy cattle health and well-being and farm productivity.

A comparative study of quality and safety of Atlantic cod (Gadus morhua) fillets during cold storage, as affected by different thawing methods of pre‐rigor frozen headed and gutted fish

PubMed Central

Jónsson, Ásbjörn; Backi, Christoph Josef; Lunestad, Bjørn Tore; Karlsdóttir, Magnea G

2017-01-01

Abstract BACKGROUND The catch of marine whitefish is typically seasonal, whereas the land‐based processing industry has a need for all‐year stable supply of raw materials. This challenge can be met by applying fish frozen at sea. When using frozen fish, the methods employed for thawing may influence the safety and quality of the final product. This study aimed to investigate the applicability of novel thawing strategies in order to provide an all‐year supply of high‐quality and safe cod products. RESULTS Comparative investigations of quality and safety factors after thawing in water, with and without air circulation, and contact thawing were performed. The parameters included water‐holding capacity, thawing loss, drip loss, cooking yield, sensory evaluation and microbiological analyses (including total volatile bases nitrogen). Water thawing with air circulation provided faster thawing than water thawing without air circulation and contact thawing. For all three methods, the quality of the thawed fish was acceptable and the shelf life of the fillets during chilled storage was between 10 and 14 days post‐filleting. CONCLUSION The results show that controlled freezing of cod, followed by appropriate thawing, may provide the processing industry with an all‐year delivery of raw materials, without compromising quality and safety of the final product. © 2017 The Authors. Journal of The Science of Food and Agriculture published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry. PMID:28862323

Effects of a team-based assessment and intervention on patient safety culture in general practice: an open randomised controlled trial.

PubMed

Hoffmann, B; Müller, V; Rochon, J; Gondan, M; Müller, B; Albay, Z; Weppler, K; Leifermann, M; Mießner, C; Güthlin, C; Parker, D; Hofinger, G; Gerlach, F M

2014-01-01

The measurement of safety culture in healthcare is generally regarded as a first step towards improvement. Based on a self-assessment of safety culture, the Frankfurt Patient Safety Matrix (FraTrix) aims to enable healthcare teams to improve safety culture in their organisations. In this study we assessed the effects of FraTrix on safety culture in general practice. We conducted an open randomised controlled trial in 60 general practices. FraTrix was applied over a period of 9 months during three facilitated team sessions in intervention practices. At baseline and after 12 months, scores were allocated for safety culture as expressed in practice structure and processes (indicators), in safety climate and in patient safety incident reporting. The primary outcome was the indicator error management. During the team sessions, practice teams reflected on their safety culture and decided on about 10 actions per practice to improve it. After 12 months, no significant differences were found between intervention and control groups in terms of error management (competing probability=0.48, 95% CI 0.34 to 0.63, p=0.823), 11 further patient safety culture indicators and safety climate scales. Intervention practices showed better reporting of patient safety incidents, reflected in a higher number of incident reports (mean (SD) 4.85 (4.94) vs 3.10 (5.42), p=0.045) and incident reports of higher quality (scoring 2.27 (1.93) vs 1.49 (1.67), p=0.038) than control practices. Applied as a team-based instrument to assess safety culture, FraTrix did not lead to measurable improvements in error management. Comparable studies with more positive results had less robust study designs. In future research, validated combined methods to measure safety culture will be required. In addition, more attention should be paid to evaluation of process parameters. Implemented actions and incident reporting may be more appropriate target endpoints. German Clinical Trials Register (Deutsches Register Klinischer Studien, DRKS) No. DRKS00000145.

Ensuring Food Security Through Enhancing Microbiological Food Safety

NASA Astrophysics Data System (ADS)

Mikš-Krajnik, Marta; Yuk, Hyun-Gyun; Kumar, Amit; Yang, Yishan; Zheng, Qianwang; Kim, Min-Jeong; Ghate, Vinayak; Yuan, Wenqian; Pang, Xinyi

2015-10-01

Food safety and food security are interrelated concepts with a profound impact on the quality of human life. Food security describes the overall availability of food at different levels from global to individual household. While, food safety focuses on handling, preparation and storage of foods in order to prevent foodborne illnesses. This review focuses on innovative thermal and non-thermal technologies in the area of food processing as the means to ensure food security through improving food safety with emphasis on the reduction and control of microbiological risks. The antimicrobial efficiency and mechanism of new technologies to extend the shelf life of food product were also discussed.

Safety: Special Effects of Thermal Runaway Chapter Heading for Encyclopedia of Electrochemical Power Sources (PREPRINT)

DTIC Science & Technology

2007-11-09

been following developments related to the recent lithium ion battery recalls and is preparing itself for revising its battery safety standard...manufacturer (OEM) Critical Components Committee. In October 2006, the IPC Lithium Ion Battery Subcommittee, that represents both the major...cover process requirements, quality control and assurance for lithium ion battery cells. Electric and Hybrid Electric Vehicle Power Source Testing In

High perfomance liquid chromatography fingerprint analysis for quality control of brotowali (Tinospora crispa)

NASA Astrophysics Data System (ADS)

Syarifah, V. B.; Rafi, M.; Wahyuni, W. T.

2017-05-01

Brotowali (Tinospora crispa) is widely used in Indonesia as ingredient of herbal medicine formulation. To ensure the quality, safety, and efficacy of herbal medicine products, its chemical constituents should be continuously evaluated. High performance liquid chromatography (HPLC) fingerprint is one of powerful technique for this quality control process. In this study, HPLC fingerprint analysis method was developed for quality control of brotowali. HPLC analysis was performed in C18 column and detection was performed using photodiode array detector. The optimum mobile phase for brotowali fingerprint was acetonitrile (ACN) and 0.1% formic acid in gradient elution mode at a flow rate of 1 mL/min. The number of peaks detected in HPLC fingerprint of brotowali was 32 peaks and 23 peaks for stems and leaves, respectively. Berberine as marker compound was detected at retention time of 20.525 minutes. Evaluation of analytical performance including precision, reproducibility, and stability prove that this HPLC fingerprint analysis was reliable and could be applied for quality control of brotowali.

Is the soil quality monitoring an effective tool in consumers' protection of agricultural crops from cadmium soil contamination?-a case of the Silesia region (Poland).

PubMed

Piekut, Agata; Baranowska, Renata; Marchwińska-Wyrwał, Ewa; Ćwieląg-Drabek, Małgorzata; Hajok, Ilona; Dziubanek, Grzegorz; Grochowska-Niedworok, Elżbieta

2017-12-16

The monitoring of soil quality should be a control tool used to reduce the adverse health effects arising from exposure to toxic chemicals in soil through cultivated crop absorption. The aim of the study was to evaluate the effectiveness of the monitoring and control system of soil quality in Poland, in terms of consumer safety, for agricultural plants cultivated in areas with known serious cadmium contamination, such as Silesia Province. To achieve the objective, the contents of cadmium in soils and vegetables in the Silesia administrative area were examined. The obtained results were compared with the results of soil contamination from the quality monitoring of arable soil in Poland. The studies show a significant exceedance of the permissible values of cadmium in soil samples and the vegetables cultivated on that soil. The threat to consumer health is a valid concern, although this threat was not indicated by the results of the national monitoring of soil quality. The results indicated an unequal distribution of risk to consumers resulting from contaminated soil. Moreover, the monitoring systems should be designed at the local or regional scale to guarantee the safety of consumers of edible plants cultivated in the areas contaminated with cadmium.

Improving Employees' Safety Awareness in Healthcare Organizations Using the DMAIC Quality Improvement Approach.

PubMed

Momani, Amer; Hirzallah, Muʼath; Mumani, Ahmad

Occupational injuries and illnesses in healthcare can cause great human suffering, incur high cost, and have an adverse impact on the quality of patient care. One of the most effective solutions for addressing health and safety issues and improving decisions at the point of care rests in raising employees' safety awareness to recognize, avoid, or respond to potential problems before they arise. In this article, the DMAIC Six Sigma model (Define, Measure, Analyze, Improve, Control) is used as a systematic program to measure, improve, and sustain employees' safety awareness in healthcare organizations. We report on a case study using the model, which was implemented and validated at a local hospital. First, the occupational health and safety knowledge that each job requires was identified. Next, the degree of competence of jobholders to meet these requirements was assessed. Based on the assessment, different awareness-raising efforts were proposed and implemented. The results showed significant improvement in the overall safety awareness compliance assessed: from 74.2% to 84.4% (p < .001) after the intervention. The proposed model ensures that the organization's awareness-raising efforts serve its actual needs and produce optimized and sustained results that eventually lead to safer healthcare service.

The effect of controlled-release ClO2 on the preservation of grapefruit

USDA-ARS?s Scientific Manuscript database

The effect of controlled-release ClO2 gas on the safety and quality of grapefruit was studied. Three different tests were run: 1) isolated peel tissue with microorganism inoculation in a chamber system; 2) individual fruit with microorganism inoculation in a chamber; and 3) boxed fruit under commerc...

Innovative Training for Occupational Health and Infection Control Workplace Assessment in Health Care

ERIC Educational Resources Information Center

O'Hara, Lyndsay; Bryce, Elizabeth Ann; Scharf, Sydney; Yassi, Annalee

2012-01-01

A user-friendly, high quality workplace assessment field guide and an accompanying worksheet are invaluable tools for recognizing hazards in the hospital environment. These tools ensure that both front line workers as well as health and safety and infection control professionals can systematically evaluate hazards and formulate recommendations.…

A Vehicle Active Safety Model: Vehicle Speed Control Based on Driver Vigilance Detection Using Wearable EEG and Sparse Representation.

PubMed

Zhang, Zutao; Luo, Dianyuan; Rasim, Yagubov; Li, Yanjun; Meng, Guanjun; Xu, Jian; Wang, Chunbai

2016-02-19

In this paper, we present a vehicle active safety model for vehicle speed control based on driver vigilance detection using low-cost, comfortable, wearable electroencephalographic (EEG) sensors and sparse representation. The proposed system consists of three main steps, namely wireless wearable EEG collection, driver vigilance detection, and vehicle speed control strategy. First of all, a homemade low-cost comfortable wearable brain-computer interface (BCI) system with eight channels is designed for collecting the driver's EEG signal. Second, wavelet de-noising and down-sample algorithms are utilized to enhance the quality of EEG data, and Fast Fourier Transformation (FFT) is adopted to extract the EEG power spectrum density (PSD). In this step, sparse representation classification combined with k-singular value decomposition (KSVD) is firstly introduced in PSD to estimate the driver's vigilance level. Finally, a novel safety strategy of vehicle speed control, which controls the electronic throttle opening and automatic braking after driver fatigue detection using the above method, is presented to avoid serious collisions and traffic accidents. The simulation and practical testing results demonstrate the feasibility of the vehicle active safety model.

A Vehicle Active Safety Model: Vehicle Speed Control Based on Driver Vigilance Detection Using Wearable EEG and Sparse Representation

PubMed Central

Zhang, Zutao; Luo, Dianyuan; Rasim, Yagubov; Li, Yanjun; Meng, Guanjun; Xu, Jian; Wang, Chunbai

2016-01-01

In this paper, we present a vehicle active safety model for vehicle speed control based on driver vigilance detection using low-cost, comfortable, wearable electroencephalographic (EEG) sensors and sparse representation. The proposed system consists of three main steps, namely wireless wearable EEG collection, driver vigilance detection, and vehicle speed control strategy. First of all, a homemade low-cost comfortable wearable brain-computer interface (BCI) system with eight channels is designed for collecting the driver’s EEG signal. Second, wavelet de-noising and down-sample algorithms are utilized to enhance the quality of EEG data, and Fast Fourier Transformation (FFT) is adopted to extract the EEG power spectrum density (PSD). In this step, sparse representation classification combined with k-singular value decomposition (KSVD) is firstly introduced in PSD to estimate the driver’s vigilance level . Finally, a novel safety strategy of vehicle speed control, which controls the electronic throttle opening and automatic braking after driver fatigue detection using the above method, is presented to avoid serious collisions and traffic accidents. The simulation and practical testing results demonstrate the feasibility of the vehicle active safety model. PMID:26907278

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.

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)

TU-EF-BRD-03: Mental Workload and Performance

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

Mazur, L.

Research related to quality and safety has been a staple of medical physics academic activities for a long time. From very early on, medical physicists have developed new radiation measurement equipment and analysis techniques, created ever increasingly accurate dose calculation models, and have vastly improved imaging, planning, and delivery techniques. These and other areas of interest have improved the quality and safety of radiotherapy for our patients. With the advent of TG-100, quality and safety is an area that will garner even more research interest in the future. As medical physicists pursue quality and safety research in greater numbers, itmore » is worthwhile to consider what actually constitutes research on quality and safety. For example, should the development of algorithms for real-time EPID-based in-vivo dosimetry be defined as “quality and safety” research? How about the clinical implementation of such as system? Surely the application of failure modes and effects analysis to a clinical process would be considered quality and safety research, but is this type of research that should be included in the medical physics peer-reviewed literature? The answers to such questions are of critical importance to set researchers in a direction that will provide the greatest benefit to our field and the patients we serve. The purpose of this symposium is to consider what constitutes research in the arena of quality and safety and differentiate it from other research directions. The key distinction here is developing the tool itself (e.g. algorithms for EPID dosimetry) vs. studying the impact of the tool with some quantitative metric. Only the latter would I call quality and safety research. Issues of ‘basic’ versus ‘applied’ quality and safety research will be covered as well as how the research results should be structured to provide increasing levels of support that a quality and safety intervention is effective and sustainable. Examples from existing peer-reviewed research will be used to highlight the main points. Historical, medical physicists have leveraged many areas of applied physics, engineering and biology to improve radiotherapy. Research on quality and safety is another area where physicists can have an impact. The key to further progress is to clearly define what constitutes quality and safety research for those interested in doing such research and the reviewers of that research. Learning Objectives: List several tools of quality and safety with references to peer-reviewed literature. Describe effects of mental workload on performance. Outline research in quality and safety indicators and technique analysis. Understand what quality and safety research needs to be going forward. Understand the links between cooperative group trials and quality and safety research.« less

Alignment issues, correlation techniques and their assessment for a visible light imaging-based 3D printer quality control system

NASA Astrophysics Data System (ADS)

Straub, Jeremy

2016-05-01

Quality control is critical to manufacturing. Frequently, techniques are used to define object conformity bounds, based on historical quality data. This paper considers techniques for bespoke and small batch jobs that are not statistical model based. These techniques also serve jobs where 100% validation is needed due to the mission or safety critical nature of particular parts. One issue with this type of system is alignment discrepancies between the generated model and the physical part. This paper discusses and evaluates techniques for characterizing and correcting alignment issues between the projected and perceived data sets to prevent errors attributable to misalignment.

The Veterans Affairs National Quality Scholars program: a model for interprofessional education in quality and safety.

PubMed

Patrician, Patricia A; Dolansky, Mary A; Pair, Vincent; Bates, Mekeshia; Moore, Shirley M; Splaine, Mark; Gilman, Stuart C

2013-01-01

The Quality and Safety Education for Nurses (QSEN) project is enhancing the emphasis on quality care and patient safety content in nursing schools. A partnership between QSEN and the Veterans Affairs National Quality Scholars program resulted in a unique experiential, interdisciplinary fellowship for both nurses and physicians. This article introduces the Veterans Affairs National Quality Scholars program and provides examples of learning activities and fellows' accomplishments. Interprofessional quality and safety education at the doctoral and postdoctoral levels is germane to improving the quality of health care.

Kaiser Permanente implant registries benefit patient safety, quality improvement, cost-effectiveness.

PubMed

Paxton, Elizabeth W; Kiley, Mary-Lou; Love, Rebecca; Barber, Thomas C; Funahashi, Tadashi T; Inacio, Maria C S

2013-06-01

In response to the increased volume, risk, and cost of medical devices, in 2001 Kaiser Permanente (KP) developed implant registries to enhance patient safety and quality, and to evaluate cost-effectiveness. Using an integrated electronic health record system, administrative databases, and other institutional databases, orthopedic, cardiology, and vascular implant registries were developed in 2001, 2006, and 2011, respectively. These registries monitor patients, implants, clinical practices, and surgical outcomes for KP's 9 million members. Critical to registry success is surgeon leadership and engagement; each geographical region has a surgeon champion who provides feedback on registry initiatives and disseminates registry findings. The registries enhance patient safety by providing a variety of clinical decision tools such as risk calculators, quality reports, risk-adjusted medical center reports, summaries of surgeon data, and infection control reports to registry stakeholders. The registries are used to immediately identify patients with recalled devices, evaluate new and established device technology, and identify outlier implants. The registries contribute to cost-effectiveness initiatives through collaboration with sourcing and contracting groups and confirming adherence to device formulary guidelines. Research studies based on registry data have directly influenced clinical best practices. Registries are important tools to evaluate longitudinal device performance and safety, study the clinical indications for and outcomes of device implantation, respond promptly to recalls and advisories, and contribute to the overall high quality of care of our patients.

Microbiological quality and safety assessment of lettuce production in Brazil.

PubMed

Ceuppens, Siele; Hessel, Claudia Titze; de Quadros Rodrigues, Rochele; Bartz, Sabrina; Tondo, Eduardo César; Uyttendaele, Mieke

2014-07-02

The microbiological quality and safety of lettuce during primary production in Brazil were determined by enumeration of hygiene indicators Escherichia coli, coliforms and enterococci and detection of enteric pathogens Salmonella and E. coli O157:H7 in organic fertilizers, soil, irrigation water, lettuce crops, harvest boxes and worker's hands taken from six different lettuce farms throughout the crop growth cycle. Generic E. coli was a suitable indicator for the presence of Salmonella and E. coli O157:H7, while coliforms and enterococci were not. Few pathogens were detected: 5 salmonellae and 2 E. coli O157:H7 from 260 samples, of which only one was lettuce and the others were manure, soil and water. Most (5/7) pathogens were isolated from the same farm and all were from organic production. Statistical analysis revealed the following environmental and agro-technical risk factors for increased microbial load and pathogen prevalence in lettuce production: high temperature, flooding of lettuce fields, application of contaminated organic fertilizer, irrigation with water of inferior quality and large distances between the field and toilets. Control of the composting process of organic fertilizers and the irrigation water quality appear most crucial to improve and/or maintain the microbiological quality and safety during the primary production of lettuce. Copyright © 2014 Elsevier B.V. All rights reserved.

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.

[Application of THz technology to nondestructive detection of agricultural product quality].

PubMed

Jiang, Yu-ying; Ge, Hong-yi; Lian, Fei-yu; Zhang, Yuan; Xia, Shan-hong

2014-08-01

With recent development of THz sources and detector, applications of THz radiation to nondestructive testing and quality control have expanded in many fields, such as agriculture, safety inspection and quality control, medicine, biochemistry, communication etc. Compared with other detection technique, being a new kind of technique, THz radiation has low energy, good perspectivity, and high signal-to-noise ratio, and thus can obtain physical, chemical and biological information. This paper first introduces the basic concept of THz radiation and the major properties, then gives an extensive review of recent research progress in detection of the quality of agricultural products via THz technique, analyzes the existing shortcomings of THz detection and discusses the outlook of potential application, finally proposes the new application of THz technique to detection of quality of stored grain.

[Aquaculture in Italy. An integrated model of product quality control].

PubMed

De Giusti, Maria; Cocchieri, Renata Amodio; De Vito, Elisabetta; Grasso, Guido Maria; Ortaggi, Giancarlo; Reali, Daniela; Ricciardi, Gualtiero; Romano-Spica, Vincenzo; Boccia, Antonio

2007-01-01

Aquaculture is becoming increasingly diffuse even in Italy. The increased production introduces new problems such as product quality control and process safety. This article presents the results of a research project, funded by the Ministry of the Environment, whose aim was to evaluate and promote aquaculture product quality and safety in an environmentally responsible way. Four intensive land-based and offshore aquaculture sites were monitored to evaluate microbiological, biological and chemical (i.e. polychlorinated biphenyls and endocrine disruptors) quality of water, products and fish feed. In total 154 samples were analysed, of which 66 were water samples, 55 product samples and 33 feed samples. Salmonella and other enteric pathogens were absent in products and the aquatic environment, while other environmental pathogens of the Vibrio species were detected. Bacterial load and fecal indicators were found to be higher in off-shore products and in mussels from all aquaculture sites. PCBs were detected in all products in concentrations below 2 microg/g fresh product (Food and Drug Administration), but on average, higher concentrations were detected in off-shore products. No estrogen mimetic activity was detected in fish feed, in contrast it was detected in offshore products and water. Product quality was found to be strictly correlated with the quality of the environment. Genetically modified organisms were detected in fish feed but no integration of genetic material in products occurred.

The efficacy and safety of a proposed herbal moisturising cream for dry skin and itch relief: a randomised, double-blind, placebo-controlled trial- study protocol

PubMed Central

2013-01-01

Background Moisturisers prevent and treat dry skin. They can also protect sensitive skin, improve skin tone and texture, and mask imperfections. Herbal medicines or their extracts have been available as topical formulations and cosmetics. Arctium lappa L. (Asteraceae) has been used to treat inflammatory disorders and various skin problems. It could be a candidate herbal medicine for treating dry skin condition. This study aims to establish the efficacy and safety of a proposed herbal moisturising cream containing Arctium lappa L. seed extract, which has been approved by the Korean Ministry of Food and Drug Safety for use in cosmetics. Methods/Designs This study is a randomised, double-blind, placebo-controlled study with two parallel groups (proposed herbal moisturising cream vs. placebo cream). We will recruit 66 healthy male and female participants, aged 20 to 65 years, who have been diagnosed with dry skin conditions. Participants will be randomly allocated to receive either the proposed herbal moisturising cream or a placebo cream for four weeks. Each participant will be examined for signs and symptoms before and after using the cream. Skin hydration, sebum (oily secretion) levels and transepidermal water loss (TEWL; constitutive loss of water from the skin surface) will be assessed. Participants will also be asked to fill out a health-related quality of life questionnaire. Safety will be assessed using blood tests, urine analysis, a pregnancy test, and the assessment of vital signs. Discussion This trial will utilise high-quality methodologies in accordance with both consolidated standards for reporting trials guidelines and the guidelines for clinical trials of cosmetics products that are aimed at expressions and advertisement approval in Korea. It will evaluate the clinical efficacy and safety of a proposed herbal moisturising cream containing Arctium lappa L. seed extract to treat dry skin conditions and provide itch relief. Moreover, we will also employ health-related quality of life questionnaires to assess changes in the quality of life. The results of this study will be used to present the evidence needed to request advertising/display allowances, in compliance with the recently amended Cosmetics Act for advertisement in Korea. Trial registration Current Controlled Trials ISRCTN46216631 PMID:24274317

A nurse-delivered, clinic-based intervention to address intimate partner violence among low-income women in Mexico City: findings from a cluster randomized controlled trial.

PubMed

Gupta, Jhumka; Falb, Kathryn L; Ponta, Oriana; Xuan, Ziming; Campos, Paola Abril; Gomez, Annabel Arellano; Valades, Jimena; Cariño, Gisele; Olavarrieta, Claudia Diaz

2017-07-12

Rigorous evaluations of health sector interventions addressing intimate partner violence (IPV) in low- and middle-income countries are lacking. We aimed to assess whether an enhanced nurse-delivered intervention would reduce IPV and improve levels of safety planning behaviors, use of community resources, reproductive coercion, and mental quality of life. We randomized 42 public health clinics in Mexico City to treatment or control arms. In treatment clinics, women received the nurse-delivered session (IPV screening, supportive referrals, health/safety risk assessments) at baseline (T1), and a booster counselling session after 3 months (T2). In control clinics, women received screening and a referral card from nurses. Surveys were conducted at T1, T2, and T3 (15 months from baseline). Our main outcome was past-year physical and sexual IPV. Intent-to-treat analyses were conducted via three-level random intercepts models to evaluate the interaction term for treatment status by time. Between April and October 2013, 950 women (480 in control clinics, 470 in treatment clinics) with recent IPV experiences enrolled in the study. While reductions in IPV were observed for both women enrolled in treatment (OR, 0.40; 95% CI, 0.28-0.55; P < 0.01) and control (OR, 0.51; 95% CI, 0.36-0.72; P < 0.01) clinics at T3 (July to December 2014), no significant treatment effects were observed (OR, 0.78; 95% CI, 0.49-1.24; P = 0.30). At T2 (July to December 2013), women in treatment clinics reported significant improvements, compared to women in control clinics, in mental quality of life (β, 1.45; 95% CI, 0.14-2.75; P = 0.03) and safety planning behaviors (β, 0.41; 95% CI, 0.02-0.79; P = 0.04). While reductions in IPV levels were seen among women in both treatment and control clinics, the enhanced nurse intervention was no more effective in reducing IPV. The enhanced nursing intervention may offer short-term improvements in addressing safety planning and mental quality of life. Nurses can play a supportive role in assisting women with IPV experiences. Clinicaltrials.gov ( NCT01661504 ). Registration Date: August 2, 2012.

Liquid and gaseous oxygen safety review, volume 1

NASA Technical Reports Server (NTRS)

Lapin, A.

1972-01-01

Materials used or contained in liquid and gaseous oxygen systems are analyzed for their compatibility; and areas of possible concern in oxygen systems are outlined. Design criteria, cleaning procedures, and quality control methods are covered in detail.

77 FR 35690 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-14

... ADVIA Centaur Anti- January 20, 2012. Diagnostics Inc. HBs2 Assay and Quality Control Material. P100005... Flowonix Medical, Prometra February 7, 2012. Inc. (approved under Programmable Medasys, Inc.). Infusion...

Materials Safety - Not just Flammability and Toxic Offgassing

NASA Technical Reports Server (NTRS)

Pedley, Michael D.

2007-01-01

For many years, the safety community has focused on a limited subset of materials and processes requirements as key to safety: Materials flammability, Toxic offgassing, Propellant compatibility, Oxygen compatibility, and Stress-corrosion cracking. All these items are important, but the exclusive focus on these items neglects many other items that are equally important to materials safety. Examples include (but are not limited to): 1. Materials process control -- proper qualification and execution of manufacturing processes such as structural adhesive bonding, welding, and forging are crucial to materials safety. Limitation of discussions on materials process control to an arbitrary subset of processes, known as "critical processes" is a mistake, because any process where the quality of the product cannot be verified by inspection can potentially result in unsafe hardware 2 Materials structural design allowables -- development of valid design allowables when none exist in the literature requires extensive testing of multiple lots of materials and is extremely expensive. But, without valid allowables, structural analysis cannot verify structural safety 3. Corrosion control -- All forms of corrosion, not just stress corrosion, can affect structural integrity of hardware 4. Contamination control during ground processing -- contamination control is critical to manufacturing processes such as adhesive bonding and also to elimination foreign objects and debris (FOD) that are hazardous to the crew of manned spacecraft in microgravity environments. 5. Fasteners -- Fastener design, the use of verifiable secondary locking features, and proper verification of fastener torque are essential for proper structural performance This presentation discusses some of these key factors and the importance of considering them in ensuring the safety of space hardware.

Cost-outcome analysis in injury prevention and control: eighty-four recent estimates for the United States.

PubMed

Miller, T R; Levy, D T

2000-06-01

The objectives of this study were to review cost-outcome analyses in injury prevention and control and estimate associated benefit-cost ratios and cost per quality-adjusted life-year. Medline and Internet search, bibliographic review, and federal agency contacts identified published and unpublished studies from 1987 to 1998 for the United States. Studies of low quality and analyses of occupational, air, rail, and water transport safety programs were excluded. Selected results were recomputed to increase discount rate, benefit category, and benefit estimate comparability and to update injury incidence rates. More than half of the 84 injury prevention measures reviewed yielded net societal cost savings. Twelve measures had costs that exceeded benefits. Of 33 road safety measures analyzed, 19 yielded net cost savings. Of 34 violence prevention approaches studied, 19 yielded net cost savings, whereas 8 had costs that exceeded benefits. Interventions with the highest benefit-cost ratios included juvenile delinquent therapy programs, fire-safe cigarettes, federal road and traffic safety program funding, lane markers painted on roads, post-mounted reflectors on hazardous curves, safety belts in front seats, safety belt laws with primary enforcement, child safety seats, child bicycle helmets, enforcement of laws against serving alcohol to the intoxicated, substance abuse treatment, brief medical interventions with heavy drinkers, and a comprehensive safe communities program in a low-income neighborhood. Studies of cost-saving measures do not exist for several injury types. Injury prevention often can reduce medical costs and save lives. Wider implementation of proven measures is warranted.

Fisheries and aquaculture industries involvement to control product health and quality safety to satisfy consumer-driven objectives on retail markets in Europe.

PubMed

Roth, Eva; Rosenthal, Harald

2006-01-01

Over the past years the export of agricultural and fishery products from developing countries has substantially increased to markets within the OECD. Retailers and importers are expanding their international operations to meet consumer demands for year-round delivery of products. Moreover, consumers have become increasingly concerned about the safety of food, including those derived from aquatic resources [FAO/NACA/WHO Joint Study Group, 1999. Report food safety issues associated with products from aquaculture. WHO Technical Report Series No 883: VII, pp. 1-55]. Governments and leading businesses are responding by imposing new safety regulations and standards to the international food system (e.g. HACCP, EUREP-GAP), product liability and labeling [Reilly, A., Howgate, P., Käferstein, F., 1997. Safety hazards and the application of HACCP in aquaculture. In: Proceedings of the Second International Conference on Fish Inspection and Quality Control: A Global Focus, Arlington, VA, 19-24 May 1996. Technomic Publishing, Lancaster, PA, pp. 353-373]. Initial concerns for imports of aquacultural products from developing to industrialized countries focussed on bacterial contamination [Buras, N. 1993. Microbial safety of produce from wastewater-fed aquaculture. In: Pullin, R.V.C., Rosenthal, H., MacLean, J.L.(Eds.), Proceedings of ICLARM Conferences, vol. 31, pp. 285-295]. Today, if trade opportunities are to be maintained, these countries must adapt to a full array of regulations and standards. This paper describes four scenarios in aquaculture and fishing product trade between developing countries and countries in the European Union.

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

PubMed

Cooper, Elizabeth

2013-01-01

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

77 FR 26280 - Patient Safety Organizations: Voluntary Relinquishment From CareRise LLC

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-03

... Organizations: Voluntary Relinquishment From CareRise LLC AGENCY: Agency for Healthcare Research and Quality... relinquishment from CareRise LLC of its status as a Patient Safety Organization (PSO). The Patient Safety and... safety and the quality of health care delivery. HHS issued the Patient Safety and Quality Improvement...

Food safety and nutritional quality for the prevention of non communicable diseases: the Nutrient, hazard Analysis and Critical Control Point process (NACCP).

PubMed

Di Renzo, Laura; Colica, Carmen; Carraro, Alberto; Cenci Goga, Beniamino; Marsella, Luigi Tonino; Botta, Roberto; Colombo, Maria Laura; Gratteri, Santo; Chang, Ting Fa Margherita; Droli, Maurizio; Sarlo, Francesca; De Lorenzo, Antonino

2015-04-23

The important role of food and nutrition in public health is being increasingly recognized as crucial for its potential impact on health-related quality of life and the economy, both at the societal and individual levels. The prevalence of non-communicable diseases calls for a reformulation of our view of food. The Hazard Analysis and Critical Control Point (HACCP) system, first implemented in the EU with the Directive 43/93/CEE, later replaced by Regulation CE 178/2002 and Regulation CE 852/2004, is the internationally agreed approach for food safety control. Our aim is to develop a new procedure for the assessment of the Nutrient, hazard Analysis and Critical Control Point (NACCP) process, for total quality management (TMQ), and optimize nutritional levels. NACCP was based on four general principles: i) guarantee of health maintenance; ii) evaluate and assure the nutritional quality of food and TMQ; iii) give correct information to the consumers; iv) ensure an ethical profit. There are three stages for the application of the NACCP process: 1) application of NACCP for quality principles; 2) application of NACCP for health principals; 3) implementation of the NACCP process. The actions are: 1) identification of nutritional markers, which must remain intact throughout the food supply chain; 2) identification of critical control points which must monitored in order to minimize the likelihood of a reduction in quality; 3) establishment of critical limits to maintain adequate levels of nutrient; 4) establishment, and implementation of effective monitoring procedures of critical control points; 5) establishment of corrective actions; 6) identification of metabolic biomarkers; 7) evaluation of the effects of food intake, through the application of specific clinical trials; 8) establishment of procedures for consumer information; 9) implementation of the Health claim Regulation EU 1924/2006; 10) starting a training program. We calculate the risk assessment as follows: Risk (R) = probability (P) × damage (D). The NACCP process considers the entire food supply chain "from farm to consumer"; in each point of the chain it is necessary implement a tight monitoring in order to guarantee optimal nutritional quality.

A Narrative Review of High-Quality Literature on the Effects of Resident Duty Hours Reforms.

PubMed

Lin, Henry; Lin, Emery; Auditore, Stephanie; Fanning, Jon

2016-01-01

To summarize current high-quality studies evaluating the effect and efficacy of resident duty hours reforms (DHRs) on patient safety and resident education and well-being. The authors searched PubMed and Medline in August 2012 and again in May 2013 for literature (1987-2013) about the effects of DHRs. They assessed the quality of articles using the Medical Education Research Study Quality Instrument (MERSQI) scoring system. They considered randomized controlled trials (RCTs), partial RCTs, and all studies with a MERSQI score ≥ 14 to be "high-quality" methodology studies. A total of 72 high-quality studies met inclusion criteria. Most studies showed no change or slight improvement in mortality and complication rates after DHRs. Resident well-being was generally improved, but there was a perceived negative impact on education (knowledge acquisition, skills, and cognitive performance) following DHRs. Eleven high-quality studies assessed the impact of DHR interventions; all reported a neutral to positive impact. Seven high-quality studies assessed costs associated with DHRs and demonstrated an increase in hospital costs. The results of most studies that allow enough time for DHR interventions to take effect suggest a benefit to patient safety and resident well-being, but the effect on the quality of training remains unknown. Additional methodologically sound studies on the impact of DHRs are necessary. Priorities for future research include approaches to optimizing education and clinical proficiency and studies on the effect of intervention strategies on both education and patient safety. Such studies will provide additional information to help improve duty hours policies.

Fundamentally updating fundamentals.

PubMed

Armstrong, Gail; Barton, Amy

2013-01-01

Recent educational research indicates that the six competencies of the Quality and Safety Education for Nurses initiative are best introduced in early prelicensure clinical courses. Content specific to quality and safety has traditionally been covered in senior level courses. This article illustrates an effective approach to using quality and safety as an organizing framework for any prelicensure fundamentals of nursing course. Providing prelicensure students a strong foundation in quality and safety in an introductory clinical course facilitates early adoption of quality and safety competencies as core practice values. Copyright © 2013 Elsevier Inc. All rights reserved.

Quality and strength of patient safety climate on medical-surgical units.

PubMed

Hughes, Linda C; Chang, Yunkyung; Mark, Barbara A

2009-01-01

Describing the safety climate in hospitals is an important first step in creating work environments where safety is a priority. Yet, little is known about the patient safety climate on medical-surgical units. Study purposes were to describe quality and strength of the patient safety climate on medical-surgical units and explore hospital and unit characteristics associated with this climate. Data came from a larger organizational study to investigate hospital and unit characteristics associated with organizational, nurse, and patient outcomes. The sample for this study was 3,689 RNs on 286 medical-surgical units in 146 hospitals. Nursing workgroup and managerial commitment to safety were the two most strongly positive attributes of the patient safety climate. However, issues surrounding the balance between job duties and safety compliance and nurses' reluctance to reveal errors continue to be problematic. Nurses in Magnet hospitals were more likely to communicate about errors and participate in error-related problem solving. Nurses on smaller units and units with lower work complexity reported greater safety compliance and were more likely to communicate about and reveal errors. Nurses on smaller units also reported greater commitment to patient safety and participation in error-related problem solving. Nursing workgroup commitment to safety is a valuable resource that can be leveraged to promote a sense of personal responsibility for and shared ownership of patient safety. Managers can capitalize on this commitment by promoting a work environment in which control over nursing practice and active participation in unit decisions are encouraged and by developing channels of communication that increase staff nurse involvement in identifying patient safety issues, prioritizing unit-level safety goals, and resolving day-to-day operational problems the have the potential to jeopardize patient safety.

[Hyaluronate sodium treatment for internal derangement of temporomandibular joint: a systematic review based on randomized controlled trials].

PubMed

Li, Chunjie; Zhang, Yifan; Jia, Yuanyuan; Lü, Jun; Li, Longjiang; Shi, Zong-Dao

2011-10-01

To assess the efficacy and safety of hyaluronate sodium (HS) for internal derangement of temporomandibular joint by means of systematic review on relevant randomized controlled trials. After identifing the study question of the efficacy and safety of HS for internal derangement of temporomandibular joint, Medline, Cochrane Controlled Trials Register, EMBASE, OPEN SIGLE and CBM were searched electronically till October 3rd 2010. Hand-searching covering 19 dental journals in Chinese were also performed. Risk of bias assessment, with Cochrane Collaboration's tool, and data extraction of included studies were conducted by two reviewers in duplicate. Meta analysis was done with Revman 5.0.23 and the quality of evidence was evaluated by GRADE. 10 randomized controlled trials met the eligibility criteria and were included. All these studies had unclear risk of bias. When compared with negative control, HS showed a significant advantage on maximal mouth opening in short and long-term (P < 0.05), and clinical overall assessment in short-term (P < 0.05), but its effect on pain control and long-term effect on clinical overall assessment had no extra benefit (P > 0.05). Additionally, when compared with glucocorticoids, the participants who received HS injection would get a better clinical overall assessment in short-term and less adverse drug reactions (P < 0.05), but presented a similar temporomandibular joint pain relief and maximal mouth opening (P > 0.05). To a certain extent, HS had good efficacy and better safety than controls when treating internal derangement of temporomandibular joint. However, as the quality of some included studies were limited, more randomized controlled trials are needed to reinforce the conclusion.

[Healthcare-Associated Infection Control with Awareness of Patient Safety].

PubMed

Murakami, Nobuo

2016-03-01

In order to provide safe and secure medical care for patients, health care-associated infections (HAI) must not occur. HAI should be considered as incidents, and countermeasures should be viewed as a patient safety management itself. Healthcare-associated infection control (HAIC) is practiced by the infection control team (ICT), which is based on multidisciplinary cooperation. Team members have to recognize that it is the most important to make use of the expertise of each discipline. In addition, all members must try to respond quickly, to help the clinic staff. Visualized rapid information provision and sharing, environmental improvement, outbreak factor analysis, hand hygiene compliance rate improvement, proper antibiotic use (Antimicrobial Stewardship Program: ASP), and regional cooperation & leadership comprise the role of the ICT in the flagship hospital. Regarding this role, we present our hospital's efforts and the outcomes. In conclusion, for medical practice quality improvement, healthcare-associated infection control should be conducted thoroughly along with an awareness of patient safety.

NASA GSFC Mechanical Engineering Latest Inputs for Verification Standards (GEVS) Updates

NASA Technical Reports Server (NTRS)

Kaufman, Daniel

2003-01-01

This viewgraph presentation provides information on quality control standards in mechanical engineering. The presentation addresses safety, structural loads, nonmetallic composite structural elements, bonded structural joints, externally induced shock, random vibration, acoustic tests, and mechanical function.

Privacy, security and access with sensitive health information.

PubMed

Croll, Peter

2010-01-01

This chapter gives an educational overview of: * Confidentiality issues and the challenges faced; * The fundamental differences between privacy and security; * The different access control mechanisms; * The challenges of Internet security; * How 'safety and quality' relate to all the above.

Criteria for determining safe water conditions for underwater operations.

DOT National Transportation Integrated Search

1984-01-01

Virginia Department of Highways and Transportation employees trained in the use of SCUBA inspect certain of the Department's bridges and provide a degree of quality control for inspections done under contract. Safety standards to be followed in divin...

Implementing a patient safety and quality program across two merged pediatric institutions.

PubMed

Abramson, Erika; Hyman, Daniel; Osorio, S Nena; Kaushal, Rainu

2009-01-01

Academic centers are among the health care organizations that have used consolidation as a strategy to improve efficiency and reduce costs. In 1997, the New York Hospital and The Presbyterian Hospital underwent a full-asset merger to become New York City's largest medical center, known as the New York-Presbyterian Hospital (NYPH). In 2006, recognition of the challenges of the Children's Service Line at NYPH led to the formation of a Patient Safety and Quality Program to deliver consistently safe and effective health care. Each campus has a children's quality council, an interdisciplinary group that discusses and prioritizes safety and quality issues. The quality councils from each campus report directly to a bicampus children's quality steering committee formed to ensure that similar safety practices and standards are implemented across both children's hospitals. A safety subcommittee, which primarily coordinates and follows up on leadership safety walk rounds, and a significant-events subcommittee, which reviews morbidities and mortalities, report to each hospital's quality council. The bicampus pediatric quality and safety program is organized around five broad themes: improving the culture of safety, reducing the frequency of health care-acquired infections, reducing harm in the health care setting, using information technology to improve the quality and safety of care provided to patients and families, and measuring the effectiveness of care in key areas. Two sample initiatives--building family engagement and prevention of adverse medication events--illustrate the program's successes and challenges. Developing a pediatric safety and quality program across two campuses has been challenging but has led to important improvements at both organizations.

The Armstrong Institute: An Academic Institute for Patient Safety and Quality Improvement, Research, Training, and Practice.

PubMed

Pronovost, Peter J; Holzmueller, Christine G; Molello, Nancy E; Paine, Lori; Winner, Laura; Marsteller, Jill A; Berenholtz, Sean M; Aboumatar, Hanan J; Demski, Renee; Armstrong, C Michael

2015-10-01

Academic medical centers (AMCs) could advance the science of health care delivery, improve patient safety and quality improvement, and enhance value, but many centers have fragmented efforts with little accountability. Johns Hopkins Medicine, the AMC under which the Johns Hopkins University School of Medicine and the Johns Hopkins Health System are organized, experienced similar challenges, with operational patient safety and quality leadership separate from safety and quality-related research efforts. To unite efforts and establish accountability, the Armstrong Institute for Patient Safety and Quality was created in 2011.The authors describe the development, purpose, governance, function, and challenges of the institute to help other AMCs replicate it and accelerate safety and quality improvement. The purpose is to partner with patients, their loved ones, and all interested parties to end preventable harm, continuously improve patient outcomes and experience, and eliminate waste in health care. A governance structure was created, with care mapped into seven categories, to oversee the quality and safety of all patients treated at a Johns Hopkins Medicine entity. The governance has a Patient Safety and Quality Board Committee that sets strategic goals, and the institute communicates these goals throughout the health system and supports personnel in meeting these goals. The institute is organized into 13 functional councils reflecting their behaviors and purpose. The institute works daily to build the capacity of clinicians trained in safety and quality through established programs, advance improvement science, and implement and evaluate interventions to improve the quality of care and safety of patients.

Economic Evaluation of Occupational Safety and Health Interventions From the Employer Perspective

PubMed Central

Grimani, Aikaterini; Bergström, Gunnar; Casallas, Martha Isabel Riaño; Aboagye, Emmanuel; Jensen, Irene; Lohela-Karlsson, Malin

2018-01-01

Objectives: The aim of this systematic review was to evaluate the cost-effectiveness of occupational safety and health interventions from the employer perspective. Methods: A comprehensive literature search (2005 to 2016) in five electronic databases was conducted. Pre-2005 studies were identified from the reference lists of previous studies and systematic reviews, which have similar objective to those of this search. Results: A total of 19 randomized controlled trials and quasi-experimental studies were included, targeting diverse health problems in a number of settings. Few studies included organizational-level interventions. When viewed in relation to the methodological quality and the sufficiency of economic evidence, five of 11 cost-effective occupational safety and health (OSH) interventions appear to be promising. Conclusion: The present systematic review highlights the need for high-quality economic evidence to evaluate the cost-effectiveness of OSH interventions, especially at organizational-level, in all areas of worker health. PMID:29112631

Long-term safety and real-world effectiveness of fingolimod in relapsing multiple sclerosis

PubMed Central

Druart, Charlotte; El Sankari, Souraya; van Pesch, Vincent

2018-01-01

With a growing number of disease-modifying therapies becoming available for relapsing multiple sclerosis, there is an important need to gather real-world evidence data regarding long-term treatment effectiveness and safety in unselected patient populations. Although not providing as high a level of evidence as randomized controlled trials, and prone to bias, real-world studies from observational studies or registries nevertheless provide crucial information on real-world outcomes of a given therapy. In addition, evaluation of treatment satisfaction and impact on quality of life are increasingly regarded as complementary outcome measures. Fingolimod was the first oral disease-modifying therapy approved for relapsing multiple sclerosis. This review aims to summarize current knowledge on the long-term effectiveness and safety outcomes of multiple sclerosis patients on fingolimod. Impact on treatment satisfaction and quality of life will be discussed according to available data. PMID:29317850

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

PubMed

Wischet, Werner; Eitzinger, Claudia

2009-01-01

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

TU-FG-201-12: Designing a Risk-Based Quality Assurance Program for a Newly Implemented Y-90 Microspheres Procedure

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

Vile, D; Zhang, L; Cuttino, L

2016-06-15

Purpose: To create a quality assurance program based upon a risk-based assessment of a newly implemented SirSpheres Y-90 procedure. Methods: A process map was created for a newly implemented SirSpheres procedure at a community hospital. The process map documented each step of this collaborative procedure, as well as the roles and responsibilities of each member. From the process map, different potential failure modes were determined as well as any current controls in place. From this list, a full failure mode and effects analysis (FMEA) was performed by grading each failure mode’s likelihood of occurrence, likelihood of detection, and potential severity.more » These numbers were then multiplied to compute the risk priority number (RPN) for each potential failure mode. Failure modes were then ranked based on their RPN. Additional controls were then added, with failure modes corresponding to the highest RPNs taking priority. Results: A process map was created that succinctly outlined each step in the SirSpheres procedure in its current implementation. From this, 72 potential failure modes were identified and ranked according to their associated RPN. Quality assurance controls and safety barriers were then added for failure modes associated with the highest risk being addressed first. Conclusion: A quality assurance program was created from a risk-based assessment of the SirSpheres process. Process mapping and FMEA were effective in identifying potential high-risk failure modes for this new procedure, which were prioritized for new quality assurance controls. TG 100 recommends the fault tree analysis methodology to design a comprehensive and effective QC/QM program, yet we found that by simply introducing additional safety barriers to address high RPN failure modes makes the whole process simpler and safer.« less

The link between leadership and safety outcomes in hospitals.

PubMed

Squires, Mae; Tourangeau, Ann; Spence Laschinger, Heather K; Doran, Diane

2010-11-01

To test and refine a model examining relationships among leadership, interactional justice, quality of the nursing work environment, safety climate and patient and nurse safety outcomes. The quality of nursing work environments may pose serious threats to patient and nurse safety. Justice is an important element in work environments that support safety initiatives yet little research has been done that looks at how leader interactional justice influences safety outcomes. A cross-sectional survey was conducted with 600 acute care registered nurses (RNs) to test and refine a model linking interactional justice, the quality of nurse leader-nurse relationships, work environment and safety climate with patient and nurse outcomes. In general the hypothesized model was supported. Resonant leadership and interactional justice influenced the quality of the leader-nurse relationship which in turn affected the quality of the work environment and safety climate. This ultimately was associated with decreased reported medication errors, intentions to leave and emotional exhaustion. Quality relationships based on fairness and empathy play a pivotal role in creating positive safety climates and work environments. To advocate for safe work environments, managers must strive to develop high-quality relationships through just leadership practices. © 2010 The Authors. Journal compilation © 2010 Blackwell Publishing Ltd.

Fluorescence-based bioassays for the detection and evaluation of food materials.

PubMed

Nishi, Kentaro; Isobe, Shin-Ichiro; Zhu, Yun; Kiyama, Ryoiti

2015-10-13

We summarize here the recent progress in fluorescence-based bioassays for the detection and evaluation of food materials by focusing on fluorescent dyes used in bioassays and applications of these assays for food safety, quality and efficacy. Fluorescent dyes have been used in various bioassays, such as biosensing, cell assay, energy transfer-based assay, probing, protein/immunological assay and microarray/biochip assay. Among the arrays used in microarray/biochip assay, fluorescence-based microarrays/biochips, such as antibody/protein microarrays, bead/suspension arrays, capillary/sensor arrays, DNA microarrays/polymerase chain reaction (PCR)-based arrays, glycan/lectin arrays, immunoassay/enzyme-linked immunosorbent assay (ELISA)-based arrays, microfluidic chips and tissue arrays, have been developed and used for the assessment of allergy/poisoning/toxicity, contamination and efficacy/mechanism, and quality control/safety. DNA microarray assays have been used widely for food safety and quality as well as searches for active components. DNA microarray-based gene expression profiling may be useful for such purposes due to its advantages in the evaluation of pathway-based intracellular signaling in response to food materials.

Fluorescence-Based Bioassays for the Detection and Evaluation of Food Materials

PubMed Central

Nishi, Kentaro; Isobe, Shin-Ichiro; Zhu, Yun; Kiyama, Ryoiti

2015-01-01

We summarize here the recent progress in fluorescence-based bioassays for the detection and evaluation of food materials by focusing on fluorescent dyes used in bioassays and applications of these assays for food safety, quality and efficacy. Fluorescent dyes have been used in various bioassays, such as biosensing, cell assay, energy transfer-based assay, probing, protein/immunological assay and microarray/biochip assay. Among the arrays used in microarray/biochip assay, fluorescence-based microarrays/biochips, such as antibody/protein microarrays, bead/suspension arrays, capillary/sensor arrays, DNA microarrays/polymerase chain reaction (PCR)-based arrays, glycan/lectin arrays, immunoassay/enzyme-linked immunosorbent assay (ELISA)-based arrays, microfluidic chips and tissue arrays, have been developed and used for the assessment of allergy/poisoning/toxicity, contamination and efficacy/mechanism, and quality control/safety. DNA microarray assays have been used widely for food safety and quality as well as searches for active components. DNA microarray-based gene expression profiling may be useful for such purposes due to its advantages in the evaluation of pathway-based intracellular signaling in response to food materials. PMID:26473869

Vertical flight path steering system for aircraft

NASA Technical Reports Server (NTRS)

Lambregts, Antonius A. (Inventor)

1983-01-01

Disclosed is a vertical flight path angle steering system for aircraft, utilizing a digital flight control computer which processes pilot control inputs and aircraft response parameters into suitable elevator commands and control information for display to the pilot on a cathode ray tube. The system yields desirable airplane control handling qualities and responses as well as improvements in pilot workload and safety during airplane operation in the terminal area and under windshear conditions.

[JUSTIFICATION OF USING EQUIVALENCE OF THE INDICES OF QUALITY, SAFETY, AND EFFICACY IN DEVELOPING BIOANALOGS].

PubMed

Niyazov, R R; Goryachev, D V; Gavrishina, E V; Romodanovskii, D P; Dranitsyna, M A

2015-01-01

We describe general principles of demonstrating biosimilarity, as well as selecting the biosimilarity margins. Any change in the structure of a biological molecule can modify its functional activity. Therefore, therapeutic equivalence between a biosimilar product and the corresponding reference product cannot be demonstrated using a single criterion. To demonstrate biosimilarity between two medicinal products, their various characteristics have to be evaluated which may, directly or indirectly, justify that clinically significant differences are absent. Insufficient understanding of 6ritical quality attributes brings a risk for the biosimilar product developer. This will either increase the number of non-clinical and clinical tests and trials needed or will result in awareness that the manufacturing process needs to be improved at the late stages of development, after investing significant resources in the development process. At the same time, the specification of the biological medicinal product cannot solely ensure safety and efficacy thereof. Properly characterized and controlled manufacturing process, which ensures consistency in its attributes not adequately controlled in specifications but influencing safety and efficacy profiles and showing their relevance in non-clinical tests and clinical trials, is an additional quality assurance factor. Justification of all development strategy details, including biosimilarity margins, has to be provided each time when the development process is initiated or when proceeding to the next steps. All problems encountered by the developer have to be resolved in close communication with the regulatory authority. In order to increase the quality of investigation and developer's adherence to good practices, clinical trial results should be published in detail.

Web Information Systems for Monitoring and Control of Indoor Air Quality at Subway Stations

NASA Astrophysics Data System (ADS)

Choi, Gi Heung; Choi, Gi Sang; Jang, Joo Hyoung

In crowded subway stations indoor air quality (IAQ) is a key factor for ensuring the safety, health and comfort of passengers. In this study, a framework for web-based information system in VDN environment for monitoring and control of IAQ in subway stations is suggested. Since physical variables that describing IAQ need to be closely monitored and controlled in multiple locations in subway stations, concept of distributed monitoring and control network using wireless media needs to be implemented. Connecting remote wireless sensor network and device (LonWorks) networks to the IP network based on the concept of VDN can provide a powerful, integrated, distributed monitoring and control performance, making a web-based information system possible.

[State of supply services for industrial hygiene and safety in Colombia].

PubMed

Varona, Marcela E; Torres, Carlos Humberto; Díaz, Sonia M; Palma, Ruth Marién; Checa, Diana Milena; Conde, Juan Vicente

2012-01-01

Institutions that supply occupational health services must offer services that are reliable and of high quality across the spectrum of industrial hygiene and safety needs. Services for occupational health were identified at several institutions, and the technical quality and reliability of these services were compared in different regions of Colombia. This descriptive study identified the services available for industrial hygiene and safety in 15 cities of Colombia. A survey was conducted in 192 institutions offering such services and a statistical analysis of these results was undertaken. This sample was taken from a nationwide list of institutions purportedly licensed for this activity. Thirty-two percent (61) of the evaluated institutions provided hygiene services, and 48% (93) provided safety services. The range of health services was provided on a subcontract basis both for professional personnel and the equipment. Six institutions in the area of industrial hygiene and 1 in the area of industrial security were supplying services with pending or suspended institutional licenses. Deficiencies in the quality, infrastructure and levels of automation were identified at institutions that supply services of hygiene and industrial security. The resulting recommendatios are that the Ministry of the Social Protection fortifies mechanisms for (1) the evaluation and control of the supplied services, and (2) verify that the institutional activity is in accordance with current and valid licensing.

Low-Cost Quality Control and Nondestructive Evaluation Technologies for General Aviation Structures

NASA Technical Reports Server (NTRS)

Cramer, K. Elliott; Gavinsky, Bob; Semanskee, Grant

1998-01-01

NASA's Advanced General Aviation Transport Experiments (AGATE) Program has as a goal to reduce the overall cost of producing private aviation aircraft while maintaining the safety of these aircraft. In order to successfully meet this goal, it is necessary to develop nondestructive inspection techniques which will facilitate the production of the materials used in these aircraft and assure the quality necessary to maintain airworthiness. This paper will discuss a particular class of general aviation materials and several nondestructive inspection techniques that have proven effective for making these inspections. Additionally, this paper will discuss the investigation and application of other commercially available quality control techniques applicable to these structures.

Handling qualities related to stall/spin accidents of supersonic fighter aircraft

NASA Technical Reports Server (NTRS)

Anderson, S. B.

1984-01-01

This paper reviews the handling qualities which influence the high angle of attack (AOA) behavior of supersonic fighter aircraft in order to obtain a clearer understanding of the causes of stall/spin accidents. The results show that, because modern fighters suffer more serious consequences when control is lost, good handling qualities are essential for safe operation at high AOA. Relaxed static stability used on some fighter aircraft can result in control problems at high AOA owing to inertia coupling and the difficulty of a recovery from a deep stall. Indications are that the use of departure/spin resistance and an automatic spin prevention system will greatly improve the safety record for modern supersonic fighters.

Water quality key to protecting patients.

PubMed

Pearson, Susan

2012-11-01

According to David Graham of the Scottish National Blood Transfusion Service (SNBTS), "the importance of the safe diagnosis and treatment of patients cannot be overstated - yet the role played by water quality in patient safety has sometimes been under-stated". David Graham was speaking at a one day Pall Medical-sponsored meeting on the prevention and control of healthcare-associated waterborne infections in healthcare facilities held in Edinburgh earlier this year. David Graham, other speakers, and the chair, Consultant Microbiologist and Infection Prevention and Control Doctor for NHS Grampian, Dr Anne Marie Karcher, stressed that good quality water is essential in healthcare premises to prevent the potentially catastrophic consequences of contaminated water for some patients. Susan Pearson BSc reports.

Hospital-Level Care at Home for Acutely Ill Adults: a Pilot Randomized Controlled Trial.

PubMed

Levine, David M; Ouchi, Kei; Blanchfield, Bonnie; Diamond, Keren; Licurse, Adam; Pu, Charles T; Schnipper, Jeffrey L

2018-05-01

Hospitals are standard of care for acute illness, but hospitals can be unsafe, uncomfortable, and expensive. Providing substitutive hospital-level care in a patient's home potentially reduces cost while maintaining or improving quality, safety, and patient experience, although evidence from randomized controlled trials in the US is lacking. Determine if home hospital care reduces cost while maintaining quality, safety, and patient experience. Randomized controlled trial. Adults admitted via the emergency department with any infection or exacerbation of heart failure, chronic obstructive pulmonary disease, or asthma. Home hospital care, including nurse and physician home visits, intravenous medications, continuous monitoring, video communication, and point-of-care testing. Primary outcome was direct cost of the acute care episode. Secondary outcomes included utilization, 30-day cost, physical activity, and patient experience. Nine patients were randomized to home, 11 to usual care. Median direct cost of the acute care episode for home patients was 52% (IQR, 28%; p = 0.05) lower than for control patients. During the care episode, home patients had fewer laboratory orders (median per admission: 6 vs. 19; p < 0.01) and less often received consultations (0% vs. 27%; p = 0.04). Home patients were more physically active (median minutes, 209 vs. 78; p < 0.01), with a trend toward more sleep. No adverse events occurred in home patients, one occurred in control patients. Median direct cost for the acute care plus 30-day post-discharge period for home patients was 67% (IQR, 77%; p < 0.01) lower, with trends toward less use of home-care services (22% vs. 55%; p = 0.08) and fewer readmissions (11% vs. 36%; p = 0.32). Patient experience was similar in both groups. The use of substitutive home-hospitalization compared to in-hospital usual care reduced cost and utilization and improved physical activity. No significant differences in quality, safety, and patient experience were noted, with more definitive results awaiting a larger trial. Trial Registration NCT02864420.

16 CFR 1000.29 - Directorate for Engineering Sciences.

Code of Federal Regulations, 2010 CFR

2010-01-01

... standards, product safety tests and test methods, performance criteria, design specifications, and quality control standards for consumer products, based on engineering and scientific methods. It conducts... consumer interest groups. The Directorate conducts human factors studies and research of consumer product...

16 CFR 1000.29 - Directorate for Engineering Sciences.

Code of Federal Regulations, 2012 CFR

2012-01-01

... standards, product safety tests and test methods, performance criteria, design specifications, and quality control standards for consumer products, based on engineering and scientific methods. It conducts... consumer interest groups. The Directorate conducts human factors studies and research of consumer product...

Illinois Manufacturing Technology Curriculum.

ERIC Educational Resources Information Center

Cliffe, Roger; And Others

This manufacturing technology curriculum involves students in learning problem-solving, communication, team building, quality control, safety, math, science, and technical skills. The document begins with a section on implementation, which gives background information on the purposes and development of the curriculum, explains its rationale,…

78 FR 6819 - Patient Safety Organizations: Voluntary Relinquishment From the BREF PSO

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-31

..., Center for Quality Improvement and Patient Safety, AHRQ, 540 Gaither Road, Rockville, MD 20850; Telephone... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety... (AHRQ), HHS. ACTION: Notice of delisting. SUMMARY: The Patient Safety and Quality Improvement Act of...

Improved statistical signal detection in pharmacovigilance by combining multiple strength-of-evidence aspects in vigiRank.

PubMed

Caster, Ola; Juhlin, Kristina; Watson, Sarah; Norén, G Niklas

2014-08-01

Detection of unknown risks with marketed medicines is key to securing the optimal care of individual patients and to reducing the societal burden from adverse drug reactions. Large collections of individual case reports remain the primary source of information and require effective analytics to guide clinical assessors towards likely drug safety signals. Disproportionality analysis is based solely on aggregate numbers of reports and naively disregards report quality and content. However, these latter features are the very fundament of the ensuing clinical assessment. Our objective was to develop and evaluate a data-driven screening algorithm for emerging drug safety signals that accounts for report quality and content. vigiRank is a predictive model for emerging safety signals, here implemented with shrinkage logistic regression to identify predictive variables and estimate their respective contributions. The variables considered for inclusion capture different aspects of strength of evidence, including quality and clinical content of individual reports, as well as trends in time and geographic spread. A reference set of 264 positive controls (historical safety signals from 2003 to 2007) and 5,280 negative controls (pairs of drugs and adverse events not listed in the Summary of Product Characteristics of that drug in 2012) was used for model fitting and evaluation; the latter used fivefold cross-validation to protect against over-fitting. All analyses were performed on a reconstructed version of VigiBase(®) as of 31 December 2004, at around which time most safety signals in our reference set were emerging. The following aspects of strength of evidence were selected for inclusion into vigiRank: the numbers of informative and recent reports, respectively; disproportional reporting; the number of reports with free-text descriptions of the case; and the geographic spread of reporting. vigiRank offered a statistically significant improvement in area under the receiver operating characteristics curve (AUC) over screening based on the Information Component (IC) and raw numbers of reports, respectively (0.775 vs. 0.736 and 0.707, cross-validated). Accounting for multiple aspects of strength of evidence has clear conceptual and empirical advantages over disproportionality analysis. vigiRank is a first-of-its-kind predictive model to factor in report quality and content in first-pass screening to better meet tomorrow's post-marketing drug safety surveillance needs.

Combination of glycolic acid peel and topical 20% azelaic acid cream in melasma patients: efficacy and improvement in quality of life.

PubMed

Dayal, Surabhi; Sahu, Priyadarshini; Dua, Ruchika

2017-03-01

Glycolic acid (GA) peel is one of the most versatile agents in the treatment of melasma. GA peeling alone or in combination with topical hypopigmenting agents has shown encouraging results. However, there is paucity of controlled trial demonstrating the efficacy of glycolic peel in conjunction with topical azelaic acid (AA). We therefore sought to highlight the efficacy and safety of this combination in melasma. To assess the clinical efficacy, safety and reduction in melasma quality of life (MELASQOL) scores on combining serial GA peels with topical 20% AA cream in epidermal melasma. Sixty patients of epidermal melasma were enrolled for 24 weeks. Patients were divided into two groups: (1) Study group received serial GA peel every 3 weeks with twice daily 20% AA cream, and (2) control group received only 20% AA cream. Clinical improvement was assessed objectively using Melasma Area Severity Index (MASI). Melasma-related quality of life was measured by MELASQOL scale in both groups. Side effects were observed at each visit. The improvement in MASI and percentage decrease in MASI scoring were statistically significant 12 weeks onwards in study group as compared to control group. There was also a significant reduction in MELASQOL scores in study group as compared to control group after treatment. Minor reversible side effects were observed in both groups, which did not require cessation of therapy. GA peel enhances therapeutic efficacy of topical AA cream for treatment of melasma, with improvement in quality of life without serious side effects. © 2016 Wiley Periodicals, Inc.

Irradiation and additive combinations on the pathogen reduction and quality of poultry meat.

PubMed

Ahn, Dong U; Kim, Il Suk; Lee, Eun Joo

2013-02-01

Reduction of foodborne illnesses and deaths by improving the safety of poultry products is one of the priority areas in the United States, and developing and implementing effective food processing technologies can be very effective to accomplish that goal. Irradiation is an effective processing technology for eliminating pathogens in poultry meat. Addition of antimicrobial agents during processing can be another approach to control pathogens in poultry products. However, the adoption of irradiation technology by the meat industry is limited because of quality and health concerns about irradiated meat products. Irradiation produces a characteristic aroma as well as alters meat flavor and color that significantly affect consumer acceptance. The generation of a pink color in cooked poultry and off-odor in poultry by irradiation is a critical issue because consumers associate the presence of a pink color in cooked poultry breast meat as contaminated or undercooked, and off-odor in raw meat and off-flavor in cooked meat with undesirable chemical reactions. As a result, the meat industry has difficulties in using irradiation to achieve its food safety benefits. Antimicrobials such as sodium lactate, sodium diacetate, and potassium benzoate are extensively used to extend the shelf-life and ensure the safety of meat products. However, the use of these antimicrobial agents alone cannot guarantee the safety of poultry products. It is known that some of the herbs, spices, and antimicrobials commonly used in meat processing can have synergistic effects with irradiation in controlling pathogens in meat. Also, the addition of spices or herbs in irradiated meat improves the quality of irradiated poultry by reducing lipid oxidation and production of off-odor volatiles or masking off-flavor. Therefore, combinations of irradiation with these additives can accomplish better pathogen reduction in meat products than using them alone even at lower levels of antimicrobials/herbs and irradiation doses. Effects of irradiation and additive combinations on the pathogen reduction and quality of poultry meat will be discussed in detail.

Sustaining Vaccine Confidence in the 21st Century

PubMed Central

Hardt, Karin; Schmidt-Ott, Ruprecht; Glismann, Steffen; Adegbola, Richard A.; Meurice, François P.

2013-01-01

Vaccination provides many health and economic benefits to individuals and society, and public support for immunization programs is generally high. However, the benefits of vaccines are often not fully valued when public discussions on vaccine safety, quality or efficacy arise, and the spread of misinformation via the internet and other media has the potential to undermine immunization programs. Factors associated with improved public confidence in vaccines include evidence-based decision-making procedures and recommendations, controlled processes for licensing and monitoring vaccine safety and effectiveness and disease surveillance. Community engagement with appropriate communication approaches for each audience is a key factor in building trust in vaccines. Vaccine safety/quality issues should be handled rapidly and transparently by informing and involving those most affected and those concerned with public health in effective ways. Openness and transparency in the exchange of information between industry and other stakeholders is also important. To maximize the safety of vaccines, and thus sustain trust in vaccines, partnerships are needed between public health sector stakeholders. Vaccine confidence can be improved through collaborations that ensure high vaccine uptake rates and that inform the public and other stakeholders of the benefits of vaccines and how vaccine safety is constantly assessed, assured and communicated. PMID:26344109

Quality management and perceptions of teamwork and safety climate in European hospitals.

PubMed

Kristensen, Solvejg; Hammer, Antje; Bartels, Paul; Suñol, Rosa; Groene, Oliver; Thompson, Caroline A; Arah, Onyebuchi A; Kutaj-Wasikowska, Halina; Michel, Philippe; Wagner, Cordula

2015-12-01

This study aimed to investigate the associations of quality management systems with teamwork and safety climate, and to describe and compare differences in perceptions of teamwork climate and safety climate among clinical leaders and frontline clinicians. We used a multi-method, cross-sectional approach to collect survey data of quality management systems and perceived teamwork and safety climate. Our data analyses included descriptive and multilevel regression methods. Data on implementation of quality management system from seven European countries were evaluated including patient safety culture surveys from 3622 clinical leaders and 4903 frontline clinicians. Perceived teamwork and safety climate. Teamwork climate was reported as positive by 67% of clinical leaders and 43% of frontline clinicians. Safety climate was perceived as positive by 54% of clinical leaders and 32% of frontline clinicians. We found positive associations between implementation of quality management systems and teamwork and safety climate. Our findings, which should be placed in a broader clinical quality improvement context, point to the importance of quality management systems as a supportive structural feature for promoting teamwork and safety climate. To gain a deeper understanding of this association, further qualitative and quantitative studies using longitudinally collected data are recommended. The study also confirms that more clinical leaders than frontline clinicians have a positive perception of teamwork and safety climate. Such differences should be accounted for in daily clinical practice and when tailoring initiatives to improve teamwork and safety climate. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Preanalytical errors in medical laboratories: a review of the available methodologies of data collection and analysis.

PubMed

West, Jamie; Atherton, Jennifer; Costelloe, Seán J; Pourmahram, Ghazaleh; Stretton, Adam; Cornes, Michael

2017-01-01

Preanalytical errors have previously been shown to contribute a significant proportion of errors in laboratory processes and contribute to a number of patient safety risks. Accreditation against ISO 15189:2012 requires that laboratory Quality Management Systems consider the impact of preanalytical processes in areas such as the identification and control of non-conformances, continual improvement, internal audit and quality indicators. Previous studies have shown that there is a wide variation in the definition, repertoire and collection methods for preanalytical quality indicators. The International Federation of Clinical Chemistry Working Group on Laboratory Errors and Patient Safety has defined a number of quality indicators for the preanalytical stage, and the adoption of harmonized definitions will support interlaboratory comparisons and continual improvement. There are a variety of data collection methods, including audit, manual recording processes, incident reporting mechanisms and laboratory information systems. Quality management processes such as benchmarking, statistical process control, Pareto analysis and failure mode and effect analysis can be used to review data and should be incorporated into clinical governance mechanisms. In this paper, The Association for Clinical Biochemistry and Laboratory Medicine PreAnalytical Specialist Interest Group review the various data collection methods available. Our recommendation is the use of the laboratory information management systems as a recording mechanism for preanalytical errors as this provides the easiest and most standardized mechanism of data capture.

Safety Assurances at Space Test Centres: Lessons Learned

NASA Astrophysics Data System (ADS)

Alarcon Ruiz, Raul; O'Neil, Sean; Valls, Rafel Prades

2010-09-01

The European Space Agency’s(ESA) experts in quality, cleanliness and contamination control, safety, test facilities and test methods have accumulated valuable experience during the performance of dedicated audits of space test centres in Europe over a period of 10 years. This paper is limited to a summary of the safety findings and provides a valuable reference to the lessons learned, identifying opportunities for improvement in the areas of risk prevention measures associated to the safety of all test centre personnel, the test specimen, the test facilities and associated infrastructure. Through the analysis of the audit results the authors present what are the main lessons learned, and conclude how an effective safety management system will contribute to successful test campaigns and have a positive impact on the cost and schedule of space projects.

Automatic-Control System for Safer Brazing

NASA Technical Reports Server (NTRS)

Stein, J. A.; Vanasse, M. A.

1986-01-01

Automatic-control system for radio-frequency (RF) induction brazing of metal tubing reduces probability of operator errors, increases safety, and ensures high-quality brazed joints. Unit combines functions of gas control and electric-power control. Minimizes unnecessary flow of argon gas into work area and prevents electrical shocks from RF terminals. Controller will not allow power to flow from RF generator to brazing head unless work has been firmly attached to head and has actuated micro-switch. Potential shock hazard eliminated. Flow of argon for purging and cooling must be turned on and adjusted before brazing power applied. Provision ensures power not applied prematurely, causing damaged work or poor-quality joints. Controller automatically turns off argon flow at conclusion of brazing so potentially suffocating gas does not accumulate in confined areas.

Omalizumab Improves Quality of Life and Asthma Control in Chinese Patients With Moderate to Severe Asthma: A Randomized Phase III Study

PubMed Central

Li, Jing; Kang, Jian; Wang, Changzheng; Yang, Jing; Wang, Linda; Kottakis, Ioannis; Humphries, Michael

2016-01-01

Purpose Omalizumab is the preferred add-on therapy for patients with moderate-to-severe persistent allergic asthma and has demonstrated efficacy and safety in various ethnicities. This study evaluated the efficacy and safety of omalizumab in Chinese patients with moderate-to-severe allergic asthma. Methods This randomized, double-blind, parallel-group, placebo-controlled, phase III study assessed lung function, quality of life, asthma control, and safety of omalizumab after 24-week therapy in Chinese patients (18-75 years of age). Results A total of 616 patients were randomized (1:1) to omalizumab or placebo. The primary endpoint, least squares mean treatment difference (LSM-TD) in morning peak expiratory flow (PEF) (omalizumab vs placebo), at Weeks >20-24 was 8.85 L/min (Full analysis set; P=0.062). Per-protocol analysis set showed significant improvements with LSM-TD of 11.53 L/min in mean mPEF at Weeks >20-24 (P=0.022). The FEV1 % predicted was significantly improved with omalizumab vs placebo from 8 to 24 weeks (after 24-week treatment: LSM-TD=4.12%; P=0.001). At Week 24, a higher proportion of omalizumab-treated patients achieved clinically relevant improvements in standardized AQLQ (58.2% vs 39.3%; LSM=0.51 vs 0.10; P<0.001) and ACQ (49.5% vs 35.5%; LSM=-0.51 vs -0.34; P=0.002) scores vs placebo. Total and nighttime symptom scores reduced significantly with omalizumab vs placebo (LSM-TD=-0.21, P=0.048 and -0.12, P=0.011, respectively). Although the study was not powered to study differences in exacerbation rates (P=0.097), exacerbations in winter months were less frequent in the omalizumab vs placebo group (2 vs 21). Adverse event and severe adverse event rates were comparable between omalizumab and placebo. Conclusions Omalizumab improves lung function, quality of life, and asthma control in Chinese patients with moderate-to-severe persistent allergic asthma and has a good safety profile. PMID:27126725

Omalizumab Improves Quality of Life and Asthma Control in Chinese Patients With Moderate to Severe Asthma: A Randomized Phase III Study.

PubMed

Li, Jing; Kang, Jian; Wang, Changzheng; Yang, Jing; Wang, Linda; Kottakis, Ioannis; Humphries, Michael; Zhong, Nanshan

2016-07-01

Omalizumab is the preferred add-on therapy for patients with moderate-to-severe persistent allergic asthma and has demonstrated efficacy and safety in various ethnicities. This study evaluated the efficacy and safety of omalizumab in Chinese patients with moderate-to-severe allergic asthma. This randomized, double-blind, parallel-group, placebo-controlled, phase III study assessed lung function, quality of life, asthma control, and safety of omalizumab after 24-week therapy in Chinese patients (18-75 years of age). A total of 616 patients were randomized (1:1) to omalizumab or placebo. The primary endpoint, least squares mean treatment difference (LSM-TD) in morning peak expiratory flow (PEF) (omalizumab vs placebo), at Weeks >20-24 was 8.85 L/min (Full analysis set; P=0.062). Per-protocol analysis set showed significant improvements with LSM-TD of 11.53 L/min in mean mPEF at Weeks >20-24 (P=0.022). The FEV1 % predicted was significantly improved with omalizumab vs placebo from 8 to 24 weeks (after 24-week treatment: LSM-TD=4.12%; P=0.001). At Week 24, a higher proportion of omalizumab-treated patients achieved clinically relevant improvements in standardized AQLQ (58.2% vs 39.3%; LSM=0.51 vs 0.10; P<0.001) and ACQ (49.5% vs 35.5%; LSM=-0.51 vs -0.34; P=0.002) scores vs placebo. Total and nighttime symptom scores reduced significantly with omalizumab vs placebo (LSM-TD=-0.21, P=0.048 and -0.12, P=0.011, respectively). Although the study was not powered to study differences in exacerbation rates (P=0.097), exacerbations in winter months were less frequent in the omalizumab vs placebo group (2 vs 21). Adverse event and severe adverse event rates were comparable between omalizumab and placebo. Omalizumab improves lung function, quality of life, and asthma control in Chinese patients with moderate-to-severe persistent allergic asthma and has a good safety profile.

Complementary and Alternative Medicine Treatments for Generalized Anxiety Disorder: Systematic Review and Meta-analysis of Randomized Controlled Trials.

PubMed

Barić, Hrvoje; Đorđević, Veljko; Cerovečki, Ivan; Trkulja, Vladimir

2018-03-01

The objective was to evaluate efficacy/safety of complementary and alternative medicine (CAM) methods for generalized anxiety disorder (GAD) based on randomized controlled trials in adults. Data sources. Six electronic databases ("generalized anxiety (disorder)" and "randomized trial") and reference lists of identified publications were searched to March 2017. Eligibility: full-text publications (English, German language); CAM versus conventional treatment, placebo/sham or no treatment; GAD diagnosed according to standard criteria; and a validated scale for disease severity. Of the 6693 screened records, 32 were included (18 on biologically-based therapies, exclusively herbal preparations; eight on manipulative and body-based therapies; and three on alternative medical systems and three on mind-body therapies). Cochrane Collaboration methodology was used for quality assessment and data extraction. Direct comparisons of Kava Kava (Piper methysticum) extracts to placebo (4 quality trials, n = 233) were highly heterogeneous. Network meta-regression reduced heterogeneity and suggested a modest Kava effect [end-of-treatment Hamilton Anxiety scale score difference adjusted for baseline scores and trial duration: - 3.24 (95% CI - 6.65, 0.17; P = 0.059), Kava Kava 4 arms, n = 139; placebo 5 arms, n = 359]. Lavender (Lavandula angustifolia) extract (1 quality trial, 10 weeks, n = 523) and a combination of extracts of C. oxycantha, E. californica and magnesium (1 quality trial, 12 weeks, n = 264) were superior to placebo and balneotherapy was superior to paroxetine (1 quality trial, 8 weeks, n = 237) indicating efficacy. All other trials were small and/or of modest/low quality and/or lacked assay sensitivity. Safety reporting was poor. Evidence about efficacy/safety of most CAM methods in GAD is limited. Apparent efficacy of certain herbal preparations and body-based therapies requires further confirmation.

COMP report: CPQR technical quality control guidelines for low-dose-rate permanent seed brachytherapy.

PubMed

Beaulieu, Luc; Radford, Dee-Ann; Eduardo Villarreal-Barajas, J

2018-03-14

The Canadian Organization of Medical Physicists (COMP), in close partnership with the Canadian Partnership for Quality Radiotherapy (CPQR) has developed a series of Technical Quality Control (TQC) guidelines for radiation treatment equipment. These guidelines outline the performance objectives that equipment should meet in order to ensure an acceptable level of radiation treatment quality. The TQC guidelines have been rigorously reviewed and field tested in a variety of Canadian radiation treatment facilities. The development process enables rapid review and update to keep the guidelines current with changes in technology. This article contains detailed performance objectives and safety criteria for low-dose-rate (LDR) permanent seed brachytherapy. © 2018 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

Global Precipitation Measurement (GPM) Safety Inhibit Timeline Tool

NASA Technical Reports Server (NTRS)

Dion, Shirley

2012-01-01

The Global Precipitation Measurement (GPM) Observatory is a joint mission under the partnership by National Aeronautics and Space Administration (NASA) and the Japan Aerospace Exploration Agency (JAXA), Japan. The NASA Goddard Space Flight Center (GSFC) has the lead management responsibility for NASA on GPM. The GPM program will measure precipitation on a global basis with sufficient quality, Earth coverage, and sampling to improve prediction of the Earth's climate, weather, and specific components of the global water cycle. As part of the development process, NASA built the spacecraft (built in-house at GSFC) and provided one instrument (GPM Microwave Imager (GMI) developed by Ball Aerospace) JAXA provided the launch vehicle (H2-A by MHI) and provided one instrument (Dual-Frequency Precipitation Radar (DPR) developed by NTSpace). Each instrument developer provided a safety assessment which was incorporated into the NASA GPM Safety Hazard Assessment. Inhibit design was reviewed for hazardous subsystems which included the High Gain Antenna System (HGAS) deployment, solar array deployment, transmitter turn on, propulsion system release, GMI deployment, and DPR radar turn on. The safety inhibits for these listed hazards are controlled by software. GPM developed a "pathfinder" approach for reviewing software that controls the electrical inhibits. This is one of the first GSFC in-house programs that extensively used software controls. The GPM safety team developed a methodology to document software safety as part of the standard hazard report. As part of this process a new tool "safety inhibit time line" was created for management of inhibits and their controls during spacecraft buildup and testing during 1& Tat GSFC and at the Range in Japan. In addition to understanding inhibits and controls during 1& T the tool allows the safety analyst to better communicate with others the changes in inhibit states with each phase of hardware and software testing. The tool was very useful for communicating compliance with safety requirements especially when working with a foreign partner.

[Colonoscopy quality control as a requirement of colorectal cancer screening].

PubMed

Quintero, Enrique; Alarcón-Fernández, Onofre; Jover, Rodrigo

2013-11-01

The strategies used in population-based colorectal screening strategies culminate in colonoscopy and consequently the success of these programs largely depends on the quality of this diagnostic test. The main factors to consider when evaluating quality are scientific-technical quality, safety, patient satisfaction, and accessibility. Quality indicators allow variability among hospitals, endoscopy units and endoscopists to be determined and can identify those not achieving recommended standards. In Spain, the working group for colonoscopy quality of the Spanish Society of Gastroenterology and the Spanish Society of Gastrointestinal Endoscopy have recently drawn up a Clinical Practice Guideline that contains the available evidence on the quality of screening colonoscopy, as well as the basic requirements that must be met by endoscopy units and endoscopists carrying out this procedure. The implementation of training programs and screening colonoscopy quality controls are strongly recommended to guarantee the success of population-based colorectal cancer screening. Copyright © 2013 Elsevier España, S.L. and AEEH y AEG. All rights reserved.

Contact and non-contact ultrasonic measurement in the food industry: a review

NASA Astrophysics Data System (ADS)

Taufiq Mohd Khairi, Mohd; Ibrahim, Sallehuddin; Yunus, Mohd Amri Md; Faramarzi, Mahdi

2016-01-01

The monitoring of the food manufacturing process is vital since it determines the safety and quality level of foods which directly affect the consumers’ health. Companies which produce high quality products will gain trust from consumers. This factor helps the companies to make profits. The use of efficient and appropriate sensors for the monitoring process can also reduce cost. The food assessing process based on an ultrasonic sensor has attracted the attention of the food industry due to its excellent capabilities in several applications. The utilization of low or high frequencies for the ultrasonic transducer has provided an enormous benefit for analysing, modifying and guaranteeing the quality of food. The contact and non-contact ultrasonic modes for measurement also contributed significantly to the food processing. This paper presents a review of the application of the contact and non-contact mode of ultrasonic measurement focusing on safety and quality control areas. The results from previous researches are shown and elaborated.

New Perspectives in Monitoring Drinking Water Microbial Quality

PubMed Central

Figueras, Ma José; Borrego, Juan J.

2010-01-01

The safety of drinking water is evaluated by the results obtained from faecal indicators during the stipulated controls fixed by the legislation. However, drinking-water related illness outbreaks are still occurring worldwide. The failures that lead to these outbreaks are relatively common and typically involve preceding heavy rain and inadequate disinfection processes. The role that classical faecal indicators have played in the protection of public health is reviewed and the turning points expected for the future explored. The legislation for protecting the quality of drinking water in Europe is under revision, and the planned modifications include an update of current indicators and methods as well as the introduction of Water Safety Plans (WSPs), in line with WHO recommendations. The principles of the WSP approach and the advances signified by the introduction of these preventive measures in the future improvement of dinking water quality are presented. The expected impact that climate change will have in the quality of drinking water is also critically evaluated. PMID:21318002

The implementation of a Hazard Analysis and Critical Control Point management system in a peanut butter ice cream plant.

PubMed

Hung, Yu-Ting; Liu, Chi-Te; Peng, I-Chen; Hsu, Chin; Yu, Roch-Chui; Cheng, Kuan-Chen

2015-09-01

To ensure the safety of the peanut butter ice cream manufacture, a Hazard Analysis and Critical Control Point (HACCP) plan has been designed and applied to the production process. Potential biological, chemical, and physical hazards in each manufacturing procedure were identified. Critical control points for the peanut butter ice cream were then determined as the pasteurization and freezing process. The establishment of a monitoring system, corrective actions, verification procedures, and documentation and record keeping were followed to complete the HACCP program. The results of this study indicate that implementing the HACCP system in food industries can effectively enhance food safety and quality while improving the production management. Copyright © 2015. Published by Elsevier B.V.

Pharmaceutical quality of "party pills" raises additional safety concerns in the use of illicit recreational drugs.

PubMed

Young, Simon A; Thrimawithana, Thilini R; Antia, Ushtana; Fredatovich, John D; Na, Yonky; Neale, Peter T; Roberts, Amy F; Zhou, Huanyi; Russell, Bruce

2013-06-14

To determine the content and release kinetics of 1-benzylpiperazine (BZP) and 1-(3-trifluoromethyl-phenyl)piperazine (TFMPP) from "party pill" formulations. From these data, the possible impact of pharmaceutical quality upon the safety of such illicit formulations may be inferred. The amount of BZP and TFMPP in party pill formulations was determined using a validated HPLC method. The in-vitro release kinetics of selected party pill brands were determined using a USP dissolution apparatus (75 rpm, 37.5 degrees Celsius). The release data were then fitted to a first order release model using PLOT software and the time taken to achieve 90% release reported. Many of the tested party pill brands contained amounts of BZP and TFMPP that varied considerably from that stated on the packaging; including considerable TFMPP content in some brands not labelled to contain this drug. Dissolution studies revealed that there was considerable variability in the release kinetics between brands; in one case 90% release required >30 minutes. Lack of quality control in party pill manufacture may have led to the toxic effects reported by users unaware of the true content and release of drug from pills. More stringent regulation in the manufacture and quality control of "new generation party pills" is essential to the harm reduction campaign.

The effectiveness of an aged care specific leadership and management program on workforce, work environment, and care quality outcomes: design of a cluster randomised controlled trial.

PubMed

Jeon, Yun-Hee; Simpson, Judy M; Chenoweth, Lynn; Cunich, Michelle; Kendig, Hal

2013-10-25

A plethora of observational evidence exists concerning the impact of management and leadership on workforce, work environment, and care quality. Yet, no randomised controlled trial has been conducted to test the effectiveness of leadership and management interventions in aged care. An innovative aged care clinical leadership program (Clinical Leadership in Aged Care--CLiAC) was developed to improve managers' leadership capacities to support the delivery of quality care in Australia. This paper describes the study design of the cluster randomised controlled trial testing the effectiveness of the program. Twenty-four residential and community aged care sites were recruited as managers at each site agreed in writing to participate in the study and ensure that leaders allocated to the control arm would not be offered the intervention program. Sites undergoing major managerial or structural changes were excluded. The 24 sites were randomly allocated to receive the CLiAC program (intervention) or usual care (control), stratified by type (residential vs. community, six each for each arm). Treatment allocation was masked to assessors and staff of all participating sites. The objective is to establish the effectiveness of the CLiAC program in improving work environment, workforce retention, as well as care safety and quality, when compared to usual care. The primary outcomes are measures of work environment, care quality and safety, and staff turnover rates. Secondary outcomes include manager leadership capacity, staff absenteeism, intention to leave, stress levels, and job satisfaction. Differences between intervention and control groups will be analysed by researchers blinded to treatment allocation using linear regression of individual results adjusted for stratification and clustering by site (primary analysis), and additionally for baseline values and potential confounders (secondary analysis). Outcomes measured at the site level will be compared by cluster-level analysis. The overall costs and benefits of the program will also be assessed. The outcomes of the trial have the potential to inform actions to enhance leadership and management capabilities of the aged care workforce, address pressing issues about workforce shortages, and increase the quality of aged care services. Australian New Zealand Clinical Trials Registry (ACTRN12611001070921).

Impact of irradiation on the safety and quality of poultry and meat products: a review.

PubMed

O'Bryan, Corliss A; Crandall, Philip G; Ricke, Steven C; Olson, Dennis G

2008-05-01

For more than 100 years research on food irradiation has demonstrated that radiation will make food safer and improve the shelf life of irradiated foods. Using the current food safety technology, we may have reached the point of diminishing returns even though recent figures from the CDC show a significant drop in the number of foodborne illnesses. However, too many people continue to get sick and die from eating contaminated food. New and under utilized technologies such as food irradiation need to be re-examined to achieve new levels of safety for the food supply. Effects of irradiation on the safety and quality of meat and poultry are discussed. Irradiation control of the principle microbial pathogens including viruses, the differences among at-risk sub-populations, factors affecting the diminished rate of improvement in food safety and published D values for irradiating raw meat and poultry are presented. Currently permitted levels of irradiation are probably not sufficient to control pathogenic viruses. Typical gram-negative spoilage organisms are very sensitive to irradiation. Their destruction leads to a significant increase in the acceptable shelf life. In addition, the destruction of these normal spoilage organisms did not provide a competitive growth advantage for irradiation injured food pathogens. Another of the main focuses of this review is a detailed compilation of the effects of most of the food additives that have been proposed to minimize the negative quality effect of irradiation. Most of the antimicrobials and antioxidants used singly or in combination produced an increased lethality of irradiation and a decrease in oxidation by-products. Combinations of dosage, temperature, dietary and direct additives, storage temperature and packaging atmosphere can produce meats that the average consumer will find indistinguishable from non-irradiated meats. A discussion of the production of unique radiological by-products is also included.

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

PubMed

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

2017-04-01

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

Trichinella diagnostics and control: mandatory and best practices for ensuring food safety.

PubMed

Gajadhar, Alvin A; Pozio, Edoardo; Gamble, H Ray; Nöckler, Karsten; Maddox-Hyttel, Charlotte; Forbes, Lorry B; Vallée, Isabelle; Rossi, Patrizia; Marinculić, Albert; Boireau, Pascal

2009-02-23

Because of its role in human disease, there are increasing global requirements for reliable diagnostic and control methods for Trichinella in food animals to ensure meat safety and to facilitate trade. Consequently, there is a need for standardization of methods, programs, and best practices used in the control of Trichinella and trichinellosis. This review article describes the biology and epidemiology of Trichinella, and describes recommended test methods as well as modified and optimized procedures that are used in meat inspection programs. The use of ELISA for monitoring animals for infection in various porcine and equine pre- and post-slaughter programs, including farm or herd certification programs is also discussed. A brief review of the effectiveness of meat processing methods, such as freezing, cooking and preserving is provided. The importance of proper quality assurance and its application in all aspects of a Trichinella diagnostic system is emphasized. It includes the use of international quality standards, test validation and standardization, critical control points, laboratory accreditation, certification of analysts and proficiency testing. Also described, are the roles and locations of international and regional reference laboratories for trichinellosis where expert advice and support on research and diagnostics are available.

Weight management program for treatment-emergent weight gain in olanzapine-treated patients with schizophrenia or schizoaffective disorder: A 12-week randomized controlled clinical trial.

PubMed

Kwon, Jun Soo; Choi, Jung-Seok; Bahk, Won-Myoung; Yoon Kim, Chang; Hyung Kim, Chan; Chul Shin, Young; Park, Byung-Joo; Geun Oh, Chang

2006-04-01

The main objective was to assess the efficacy of a weight management program designed for outpatients taking olanzapine for schizophrenia or schizoaffective disorder and to compare these patients with a randomized control group. The effects of the weight management program were also assessed with regard to safety and quality of life. Forty-eight patients were enrolled in a 12-week, randomized, multicenter weight management study. Thirty-three patients were randomly allocated to an intervention group in which they received olanzapine within a weight management program. Fifteen patients were allocated to a control group in which they were given olanzapine treatment as usual outpatients. Weight, body mass index (BMI), and measurements of safety and quality of life were evaluated. The study was conducted from January 7, 2003, to September 16, 2003. Thirty-six patients (75%) completed this study. We found significant differences in weight (-3.94 +/- 3.63 kg vs. -1.48 +/- 1.88 kg, p = .006) and BMI (-1.50 +/- 1.34 vs. -0.59 +/- 0.73, p = .007) change from baseline to endpoint between the intervention and control groups, respectively. Significant differences in weight reduction were initially observed at week 8 (p = .040). No significant differences were found with regard to the safety outcomes. When the ratio of low-density lipoproteins to high-density lipoproteins was calculated, change from baseline was greater in the intervention group than the control group (-0.19 vs. -0.04), but the difference was not statistically significant (p = .556). After the completion of the weight management program, there was a trend toward statistical difference in the physical health score changes between the weight management and control groups (1.12 in the intervention group vs. -0.93 in the control group, p = .067). The weight management program was effective in terms of weight reduction in patients with schizophrenia or schizoaffective disorder taking olanzapine and was also found to be safe in terms of psychiatric symptoms, vital signs, and laboratory data. In addition, such a weight management program might improve quality of life in patients with schizophrenia or schizoaffective disorder with respect to their physical well-being.

Effects of health information technology on patient outcomes: a systematic review.

PubMed

Brenner, Samantha K; Kaushal, Rainu; Grinspan, Zachary; Joyce, Christine; Kim, Inho; Allard, Rhonda J; Delgado, Diana; Abramson, Erika L

2016-09-01

To systematically review studies assessing the effects of health information technology (health IT) on patient safety outcomes. The authors employed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement methods. MEDLINE, Cumulative Index to Nursing Allied Health (CINAHL), EMBASE, and Cochrane Library databases, from 2001 to June 2012, were searched. Descriptive and comparative studies were included that involved use of health IT in a clinical setting and measured effects on patient safety outcomes. Data on setting, subjects, information technology implemented, and type of patient safety outcomes were all abstracted. The quality of the studies was evaluated by 2 independent reviewers (scored from 0 to 10). A total of 69 studies met inclusion criteria. Quality scores ranged from 1 to 9. There were 25 (36%) studies that found benefit of health IT on direct patient safety outcomes for the primary outcome measured, 43 (62%) studies that either had non-significant or mixed findings, and 1 (1%) study for which health IT had a detrimental effect. Neither the quality of the studies nor the rate of randomized control trials performed changed over time. Most studies that demonstrated a positive benefit of health IT on direct patient safety outcomes were inpatient, single-center, and either cohort or observational trials studying clinical decision support or computerized provider order entry. Many areas of health IT application remain understudied and the majority of studies have non-significant or mixed findings. Our study suggests that larger, higher quality studies need to be conducted, particularly in the long-term care and ambulatory care settings. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Measuring hospital-wide activity volume for patient safety and infection control: a multi-centre study in Japan.

PubMed

Hayashida, Kenshi; Imanaka, Yuichi; Fukuda, Haruhisa

2007-09-03

In Japan, as in many other countries, several quality and safety assurance measures have been implemented since the 1990's. This has occurred in spite of cost containment efforts. Although government and hospital decision-makers demand comprehensive analysis of these activities at the hospital-wide level, there have been few studies that actually quantify them. Therefore, the aims of this study were to measure hospital-wide activities for patient safety and infection control through a systematic framework, and to identify the incremental volume of these activities implemented over the last five years. Using the conceptual framework of incremental activity corresponding to incremental cost, we defined the scope of patient safety and infection control activities. We then drafted a questionnaire to analyze these realms. After implementing the questionnaire, we conducted several in-person interviews with managers and other staff in charge of patient safety and infection control in seven acute care teaching hospitals in Japan. At most hospitals, nurses and clerical employees acted as the main figures in patient safety practices. The annual amount of activity ranged from 14,557 to 72,996 person-hours (per 100 beds: 6,240; per 100 staff: 3,323) across participant hospitals. Pharmacists performed more incremental activities than their proportional share. With respect to infection control activities, the annual volume ranged from 3,015 to 12,196 person-hours (per 100 beds: 1,141; per 100 staff: 613). For infection control, medical doctors and nurses tended to perform somewhat more of the duties relative to their share. We developed a systematic framework to quantify hospital-wide activities for patient safety and infection control. We also assessed the incremental volume of these activities in Japanese hospitals under the reimbursement containment policy. Government and hospital decision makers can benefit from this type of analytic framework and its empirical findings.

Design of Low Complexity Model Reference Adaptive Controllers

NASA Technical Reports Server (NTRS)

Hanson, Curt; Schaefer, Jacob; Johnson, Marcus; Nguyen, Nhan

2012-01-01

Flight research experiments have demonstrated that adaptive flight controls can be an effective technology for improving aircraft safety in the event of failures or damage. However, the nonlinear, timevarying nature of adaptive algorithms continues to challenge traditional methods for the verification and validation testing of safety-critical flight control systems. Increasingly complex adaptive control theories and designs are emerging, but only make testing challenges more difficult. A potential first step toward the acceptance of adaptive flight controllers by aircraft manufacturers, operators, and certification authorities is a very simple design that operates as an augmentation to a non-adaptive baseline controller. Three such controllers were developed as part of a National Aeronautics and Space Administration flight research experiment to determine the appropriate level of complexity required to restore acceptable handling qualities to an aircraft that has suffered failures or damage. The controllers consist of the same basic design, but incorporate incrementally-increasing levels of complexity. Derivations of the controllers and their adaptive parameter update laws are presented along with details of the controllers implementations.

Introduction to HACCP.

USDA-ARS?s Scientific Manuscript database

Introduction to HACCP Deana R. Jones, Ph.D. Egg Safety and Quality Research Unit USDA-Agricultural Research Service Russell Research Center Athens, GA Deana.Jones@ars.usda.gov HACCP is an acronym for Hazard Analysis and Critical Control Point and was initially developed by the Pillsbury Company a...

Data available on the impact of drug use on transportation safety

DOT National Transportation Integrated Search

1988-05-01

The report assesses the available data on drug use in transportation, the relevant experimental research on the impacts of drugs, and the state-of-the-art in drug analysis and toxicological quality control. The report describes and evaluates: informa...

21 CFR 107.50 - Terms and conditions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR... manufacturer shall maintain records of such quality control procedures sufficient to permit a public health... Food Safety and Applied Nutrition will review information submitted by infant formula manufacturers...

Flu vaccine shortage creates ethical issues, safety challenges.

PubMed

2004-12-01

Decisions may have to be made as to whether staff or patients get priority. Centers for Disease Control and Prevention guidelines help ease choices when it comes to inoculating workers. Quality professionals should be aware of the legal implications of their decisions.

Liquid and gaseous oxygen safety review

NASA Technical Reports Server (NTRS)

Lapin, A.

1973-01-01

Materials used in oxygen systems and allowable oxygen environments are specified for each material. Design criteria, cleaning procedures and quality control methods are covered. Guidelines for protection against hazards involved with production, transportation, storage and use of oxygen are presented. Study also lists extensive references.

Contribution of European research to risk analysis.

PubMed

Boenke, A

2001-12-01

The European Commission's, Quality of Life Research Programme, Key Action 1-Health, Food & Nutrition is mission-oriented and aims, amongst other things, at providing a healthy, safe and high-quality food supply leading to reinforced consumer confidence in the safety, of European food. Its objectives also include the enhancing of the competitiveness of the European food supply. Key Action 1 is currently supporting a number of different types of European collaborative projects in the area of risk analysis. The objectives of these projects range from the development and validation of prevention strategies including the reduction of consumers risks; development and validation of new modelling approaches, harmonization of risk assessment principles methodologies and terminology; standardization of methods and systems used for the safety evaluation of transgenic food; providing of tools for the evaluation of human viral contamination of shellfish and quality control; new methodologies for assessing the potential of unintended effects of genetically modified (genetically modified) foods; development of a risk assessment model for Cryptosporidium parvum related to the food and water industries, to the development of a communication platform for genetically modified organism, producers, retailers, regulatory authorities and consumer groups to improve safety assessment procedures, risk management strategies and risk communication; development and validation of new methods for safety testing of transgenic food; evaluation of the safety and efficacy of iron supplementation in pregnant women, evaluation of the potential cancer-preventing activity of pro- and pre-biotic ('synbiotic') combinations in human volunteers. An overview of these projects is presented here.

Infection prevention and control strategies in the era of limited resources and quality improvement: a perspective paper.

PubMed

Vandijck, Dominique; Cleemput, Irina; Hellings, Johan; Vogelaers, Dirk

2013-11-01

This paper aims to describe, using an evidence-based approach, the importance of and the resources necessary for implementing effective infection prevention and control (IPC) programmes. The intrinsic and explicit values of such strategies are presented from a clinical, health-economic and patient safety perspective. Policy makers and hospital managers are committed to providing comprehensive, accessible, and affordable healthcare of high quality. Changes in the healthcare system over time accompanied with variations in demographics and case-mix have considerably affected the availability, quality and ultimately the safety of healthcare. The main goal of an IPC programme is to prevent and control healthcare-associated infections (HAI). Many patient-, healthcare provider-, and organizational factors are associated with an increased risk for acquiring HAIs and may impact both the quality and outcome of patient care. Evidence has been published in support of having an effective IPC programme. It has been estimated that about one-third of HAIs could be prevented if key elements of the evidence-based recommendations for IPC are adequately introduced and followed. However, several healthcare agencies from over the world have reported deficits in the essential resources and components of current IPC programmes. To meet its main goal, staffing, training, and infrastructure requirements are needed. Nevertheless, and given the economic crisis, policy makers and hospital managers may be tempted to not increase or even to reduce the budget as it consumes resources and does not generate sufficient visible revenue. IPC is a critical issue in patient safety, as HAIs are by far the most common complication affecting admitted patients. The significant clinical and health-economic burden HAIs place on the healthcare system speak to the importance of getting introduced effective IPC programmes. Copyright © 2013 Australian College of Critical Care Nurses Ltd. Published by Elsevier Ltd. All rights reserved.

Experimental based experiences with the introduction of a water safety plan for a multi-located university clinic and its efficacy according to WHO recommendations

PubMed Central

Dyck, Alexander; Exner, Martin; Kramer, Axel

2007-01-01

Background Due to the high number of immunosuppressed and other predisposed patients hospitals have to control and ensure the microbiological water quality. The origin for the occurrence of pathogenic microorganisms in water pipes is the formation of biofilm. Methods For the permanent control of water safety a water safety plan (WSP) was realized as recommended by the WHO following the principle "search and destroy". The WSP is based on an established HACCP concept due to the special focus. The most important measures include the concept for sample taking depending on patient risk. 3 different categories) are distinguished: risk area1 (high infection risk), risk 2 (moderate infection risk), and risk area 3 (not increased infection risk). Additionally to the threshold value of the German law for the quality of drinking water (TrinkwV) three more limiting values were defined (warning, alert, and worst case) for immediate risk adapted reaction. Additional attention has to be focussed on lavatory sinks, which are an open bacterial reservoir. Therefore continuous disinfecting siphons were installed as part of the WSP in high risk areas. If extended technical equipment is not available, especially for immunocompromised patients the following measures are easy to realize: boiled (or sun exposed) water for nursing procedures as well alimentary use, no showering. Results Comparing data over 3 years the microbial water quality was significantly improved resulting in no new case of nosocomial Legionella pneumoniae and decrease in neonatal sepsis. Conclusion According to average situations with highly contaminated water system the management must be defined with implementation of water task force, immediate providing of special equipment, information of patients and staff and control of the water quality, an example for successful decontamination of the hospital within 24 hours is given. PMID:17355621

Establishing a Quality Control System for Stem Cell-Based Medicinal Products in China

PubMed Central

2015-01-01

Stem cell-based medicinal products (SCMPs) are emerging as novel therapeutic products. The success of its development depends on the existence of an effective quality control system, which is constituted by quality control technologies, standards, reference materials, guidelines, and the associated management system in accordance with regulatory requirements along product lifespan. However, a worldwide, effective quality control system specific for SCMPs is still far from established partially due to the limited understanding of stem cell sciences and lack of quality control technologies for accurately assessing the safety and biological effectiveness of SCMPs before clinical use. Even though, based on the existing regulations and current stem cell sciences and technologies, initial actions toward the goal of establishing such a system have been taken as exemplified by recent development of new “interim guidelines” for governing quality control along development of SCMPs and new development of the associated quality control technologies in China. In this review, we first briefly introduced the major institutions involved in the regulation of cell substrates and therapeutic cell products in China and the existing regulatory documents and technical guidelines used as critical references for developing the new interim guidelines. With focus only on nonhematopoietic stem cells, we then discussed the principal quality attributes of SCMPs as well as our thinking of proper testing approaches to be established with relevant evaluation technologies to ensure all quality requirements of SCMPs along different manufacturing processes and development stages. At the end, some regulatory and technical challenges were also discussed with the conclusion that combined efforts should be taken to promote stem cell regulatory sciences to establish the effective quality control system for SCMPs. PMID:25471126

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

PubMed

Naveh, Eitan; Katz-Navon, Tal

2014-01-01

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

Quality assurance of radiotherapy in cancer treatment: toward improvement of patient safety and quality of care.

PubMed

Ishikura, Satoshi

2008-11-01

The process of radiotherapy (RT) is complex and involves understanding of the principles of medical physics, radiobiology, radiation safety, dosimetry, radiation treatment planning, simulation and interaction of radiation with other treatment modalities. Each step in the integrated process of RT needs quality control and quality assurance (QA) to prevent errors and to give high confidence that patients will receive the prescribed treatment correctly. Recent advances in RT, including intensity-modulated and image-guided RT, focus on the need for a systematic RTQA program that balances patient safety and quality with available resources. It is necessary to develop more formal error mitigation and process analysis methods, such as failure mode and effect analysis, to focus available QA resources optimally on process components. External audit programs are also effective. The International Atomic Energy Agency has operated both an on-site and off-site postal dosimetry audit to improve practice and to assure the dose from RT equipment. Several countries have adopted a similar approach for national clinical auditing. In addition, clinical trial QA has a significant role in enhancing the quality of care. The Advanced Technology Consortium has pioneered the development of an infrastructure and QA method for advanced technology clinical trials, including credentialing and individual case review. These activities have an impact not only on the treatment received by patients enrolled in clinical trials, but also on the quality of treatment administered to all patients treated in each institution, and have been adopted globally; by the USA, Europe and Japan also.

Safety and efficacy of pharmacologic thromboprophylaxis following blunt head injury: a systematic review.

PubMed

Reeves, Fairleigh; Batty, Lachlan; Pitt, Veronica; Chau, Marisa; Pattuwage, Loyal; Gruen, Russell L

2013-10-01

Patients with blunt head injury are at high risk of venous thromboembolism. However, pharmacologic thromboprophylaxis (PTP) may cause progression of intracranial hemorrhage, and clinicians must often weigh up the risks and benefits. This review aimed to determine whether adding PTP to mechanical prophylaxis confers net benefit or harm and the optimal timing, dose, and agent for PTP in patients with blunt head injury. We searched MEDLINE, EMBASE, The Cochrane Library Central Register of Controlled Trials (CENTRAL), and www.clinicaltrials.gov on April 24, 2013, to identify controlled studies and ongoing trials that assessed the efficacy or safety of thromboprophylaxis interventions in the early management of head-injured patients. Studies were classified based on types of interventions and comparisons, and the quality of included studies was assessed using Cochrane risk-of-bias tool and the Newcastle-Ottawa Quality Assessment Scale. We intended to undertake a meta-analysis if studies were sufficiently similar. Sixteen studies met the inclusion criteria, including four randomized controlled trials. At least two randomized controlled trials were at high risk of bias owing to inadequate randomization and concealment of allocation, and observational studies were potentially confounded by substantial differences between comparison groups. Heterogeneity of included studies precluded meta-analysis. Results were mixed, with some studies supporting and others refuting addition of PTP to mechanical interventions. Little evidence was available about dose or choice of agent. The safety and efficacy of early PTP in patients without early progression of hemorrhage is unclear. There is currently insufficient evidence to guide thromboprophylaxis in patients with blunt head injury. Standardized definitions and outcome measurements would facilitate comparison of outcomes across future studies. Studies in mixed populations should report head-injured specific subgroup data. Future randomized controlled trials should investigate the efficacy and safety of early pharmacologic prophylaxis in addition to mechanical intervention. Systematic review, level IV.

Hot and Cold Therapy Eases Pain

NASA Technical Reports Server (NTRS)

2004-01-01

In the 1960s, NASA civil servant Tom Hughes worked for Marshall Space Flight Center s Quality Control Laboratory as a systems engineer. Reporting directly to Dr. Wernher von Braun, Marshall s first director, Hughes was assigned as a NASA representative for quality control at the Michoud Assembly Facility in New Orleans, Louisiana, to oversee the Saturn V rocket project. During this time, Hughes invented several technologies to improve the safety of the rocket, earning several commendations from von Braun. He also gained technical expertise in microwave technology, as NASA researched it to determine its relationship to radar.

Generating Options for Active Risk Control (GO-ARC): introducing a novel technique.

PubMed

Card, Alan J; Ward, James R; Clarkson, P John

2014-01-01

After investing significant amounts of time and money in conducting formal risk assessments, such as root cause analysis (RCA) or failure mode and effects analysis (FMEA), healthcare workers are left to their own devices in generating high-quality risk control options. They often experience difficulty in doing so, and tend toward an overreliance on administrative controls (the weakest category in the hierarchy of risk controls). This has important implications for patient safety and the cost effectiveness of risk management operations. This paper describes a before and after pilot study of the Generating Options for Active Risk Control (GO-ARC) technique, a novel tool to improve the quality of the risk control options generation process. The quantity, quality (using the three-tiered hierarchy of risk controls), variety, and novelty of risk controls generated. Use of the GO-ARC technique was associated with improvement on all measures. While this pilot study has some notable limitations, it appears that the GO-ARC technique improved the risk control options generation process. Further research is needed to confirm this finding. It is also important to note that improved risk control options are a necessary, but not sufficient, step toward the implementation of more robust risk controls. © 2013 National Association for Healthcare Quality.

The Relationship Between Professional Burnout and Quality and Safety in Healthcare: A Meta-Analysis.

PubMed

Salyers, Michelle P; Bonfils, Kelsey A; Luther, Lauren; Firmin, Ruth L; White, Dominique A; Adams, Erin L; Rollins, Angela L

2017-04-01

Healthcare provider burnout is considered a factor in quality of care, yet little is known about the consistency and magnitude of this relationship. This meta-analysis examined relationships between provider burnout (emotional exhaustion, depersonalization, and reduced personal accomplishment) and the quality (perceived quality, patient satisfaction) and safety of healthcare. Publications were identified through targeted literature searches in Ovid MEDLINE, PsycINFO, Web of Science, CINAHL, and ProQuest Dissertations & Theses through March of 2015. Two coders extracted data to calculate effect sizes and potential moderators. We calculated Pearson's r for all independent relationships between burnout and quality measures, using a random effects model. Data were assessed for potential impact of study rigor, outliers, and publication bias. Eighty-two studies including 210,669 healthcare providers were included. Statistically significant negative relationships emerged between burnout and quality (r = -0.26, 95 % CI [-0.29, -0.23]) and safety (r = -0.23, 95 % CI [-0.28, -0.17]). In both cases, the negative relationship implied that greater burnout among healthcare providers was associated with poorer-quality healthcare and reduced safety for patients. Moderators for the quality relationship included dimension of burnout, unit of analysis, and quality data source. Moderators for the relationship between burnout and safety were safety indicator type, population, and country. Rigor of the study was not a significant moderator. This is the first study to systematically, quantitatively analyze the links between healthcare provider burnout and healthcare quality and safety across disciplines. Provider burnout shows consistent negative relationships with perceived quality (including patient satisfaction), quality indicators, and perceptions of safety. Though the effects are small to medium, the findings highlight the importance of effective burnout interventions for healthcare providers. Moderator analyses suggest contextual factors to consider for future study.

[Motor skills and safety of patients with bi- or trimalleolar ankle injury : Comparison with healthy, active, age-matched control subjects].

PubMed

Loudovici-Krug, Dana; Benkenstein, Monique; Derlien, Steffen; Best, Norman

2018-06-01

Do patients with bi- or trimalleolar ankle injury show differences in motor skills and safety in comparison with healthy, active, age-matched control subjects? Prospective controlled cross-sectional study. Inclusion of 17 patients with bi- or trimalleolar ankle injury (mean 1.5 years postsurgery) and 23 healthy, active subjects of comparable age (fitness studio). Measurement instruments: motor test procedures and questionnaires. Comparison of patients and control subjects by routine daily motor function: patients < controls with the "timed 'Up & Go' test" (TUG, p = 0.011), the chair rising test and a coordination test using a gymnastic hoop (CRT and GR p > 0.05), fear of falling: patients > controls (p = 0.003) and physical activity: patients < controls (p = 0.032). There were no significant motor deficits in activities of daily life between the patients and controls, only tendencies; however, the patients showed definite limitations with an increased fear of falling and a reduced physical activity compared with the healthy control group. The resulting differences should be positively influenced by appropriate enhancement of training or participation in sports courses. The aim is to achieve a similar quality of life by a perception of safety and trust in one's own motor skills.

NASA/Navy Benchmarking Exchange (NNBE). Volume 1. Interim Report. Navy Submarine Program Safety Assurance

NASA Technical Reports Server (NTRS)

2002-01-01

The NASA/Navy Benchmarking Exchange (NNBE) was undertaken to identify practices and procedures and to share lessons learned in the Navy's submarine and NASA's human space flight programs. The NNBE focus is on safety and mission assurance policies, processes, accountability, and control measures. This report is an interim summary of activity conducted through October 2002, and it coincides with completion of the first phase of a two-phase fact-finding effort.In August 2002, a team was formed, co-chaired by senior representatives from the NASA Office of Safety and Mission Assurance and the NAVSEA 92Q Submarine Safety and Quality Assurance Division. The team closely examined the two elements of submarine safety (SUBSAFE) certification: (1) new design/construction (initial certification) and (2) maintenance and modernization (sustaining certification), with a focus on: (1) Management and Organization, (2) Safety Requirements (technical and administrative), (3) Implementation Processes, (4) Compliance Verification Processes, and (5) Certification Processes.

Implementation of Programmatic Quality and the Impact on Safety

NASA Technical Reports Server (NTRS)

Huls, Dale Thomas; Meehan, Kevin

2005-01-01

The purpose of this paper is to discuss the implementation of a programmatic quality assurance discipline within the International Space Station Program and the resulting impact on safety. NASA culture has continued to stress safety at the expense of quality when both are extremely important and both can equally influence the success or failure of a Program or Mission. Although safety was heavily criticized in the media after Colimbiaa, strong case can be made that it was the failure of quality processes and quality assurance in all processes that eventually led to the Columbia accident. Consequently, it is possible to have good quality processes without safety, but it is impossible to have good safety processes without quality. The ISS Program quality assurance function was analyzed as representative of the long-term manned missions that are consistent with the President s Vision for Space Exploration. Background topics are as follows: The quality assurance organizational structure within the ISS Program and the interrelationships between various internal and external organizations. ISS Program quality roles and responsibilities with respect to internal Program Offices and other external organizations such as the Shuttle Program, JSC Directorates, NASA Headquarters, NASA Contractors, other NASA Centers, and International Partner/participants will be addressed. A detailed analysis of implemented quality assurance responsibilities and functions with respect to NASA Headquarters, the JSC S&MA Directorate, and the ISS Program will be presented. Discussions topics are as follows: A comparison of quality and safety resources in terms of staffing, training, experience, and certifications. A benchmark assessment of the lessons learned from the Columbia Accident Investigation (CAB) Report (and follow-up reports and assessments), NASA Benchmarking, and traditional quality assurance activities against ISS quality procedures and practices. The lack of a coherent operational and sustaining quality assurance strategy for long-term manned space flight. An analysis of the ISS waiver processes and the Problem Reporting and Corrective Action (PRACA) process implemented as quality functions. Impact of current ISS Program procedures and practices with regards to operational safety and risk A discussion regarding a "defense-in-depth" approach to quality functions will be provided to address the issue of "integration vs independence" with respect to the roles of Programs, NASA Centers, and NASA Headquarters. Generic recommendations are offered to address the inadequacies identified in the implementation of ISS quality assurance. A reassessment by the NASA community regarding the importance of a "quality culture" as a component within a larger "safety culture" will generate a more effective and value-added functionality that will ultimately enhance safety.

The influence of handling qualities on safety and survivability

NASA Technical Reports Server (NTRS)

Anderson, S. B.

1977-01-01

The relationship of handling qualities to safety and survivability of military aircraft is examined which includes the following: (1) a brief discussion of the philosophy used in the military specifications for treatment of degraded handling qualities, (2) an examination of several example handling qualities problem areas which influence safety and survivability; and (3) a movie illustrating the potential dangers of inadequate handling qualities features.

Rhodiola rosea therapy for major depressive disorder: a study protocol for a randomized, double-blind, placebo- controlled trial

PubMed Central

Mao, Jun J; Li, Qing S.; Soeller, Irene; Xie, Sharon X; Amsterdam, Jay D.

2014-01-01

Background Rhodiola rosea (R. rosea), a botanical of both western and traditional Chinese medicine, has been used as a folk remedy for improving stamina and reducing stress. However, few controlled clinical trials have examined the safety and efficacy of R. rosea for the treatment of major depressive disorder (MDD). This study seeks to evaluate the safety and efficacy of R. rosea in a 12-week, randomized, double-blind, placebo-controlled, parallel group study design. Methods / Design Subjects with MDD not receiving antidepressant therapy will be randomized to either R. rosea extract 340–1,360 mg daily; sertraline 50–200 mg daily, or placebo for 12 weeks. The primary outcome measure will be change over time in the mean 17-item Hamilton Depression Rating score. Secondary outcome measures will include safety and quality of life ratings. Statistical procedures will include mixed-effects models to assess efficacy for primary and secondary outcomes. Discussion This study will provide valuable preliminary information on the safety and efficacy data of R. rosea versus conventional antidepressant therapy of MDD. It will also inform additional hypotheses and study design of future, fully powered, phase III clinical trials with R. rosea to determine its safety and efficacy in MDD. PMID:25610752

[The external quality assessment schemes for lead in blood organized by the French national agency for medicine and health product safety: a synthesis of 15 years of activity].

PubMed

Pineau, Alain; Otz, Jocelyne; Guillard, Olivier; Fauconneau, Bernard; Dumont, Gilles; François-Burg, Elisabeth

2014-01-01

In 1992, at the request of the French labor ministry following questions on the ability of medical biology laboratories to satisfactorily measure blood lead level (PbB), a national PbB quality control came into being. Only in 1996 did this external quality control include a number of laboratories sufficient to allow for a significant retrospective evaluation. After fifteen years (1996-2011), The French National Agency for Medicines and Health Products Safety wished to exploit the database collected. The number of participating laboratories went down from 73 to 41. On the other hand, the key finding pertained to the highly improved performance of the laboratories, which was associated with a spread decrease of the results over the entire range of tested PbBs (9 to 700 μg/L). Since 2006, we have observed increasing use of the inductively coupled plasma with mass spectrometry and decreasing use of electrothermal atomic absorption spectrometry. Provided that they rely on identical metrology expertise, the two analytical techniques lead to results on all the tested concentrations that are not statistically different.

Preventing Harm in the ICU-Building a Culture of Safety and Engaging Patients and Families.

PubMed

Thornton, Kevin C; Schwarz, Jennifer J; Gross, A Kendall; Anderson, Wendy G; Liu, Kathleen D; Romig, Mark C; Schell-Chaple, Hildy; Pronovost, Peter J; Sapirstein, Adam; Gropper, Michael A; Lipshutz, Angela K M

2017-09-01

Preventing harm remains a persistent challenge in the ICU despite evidence-based practices known to reduce the prevalence of adverse events. This review seeks to describe the critical role of safety culture and patient and family engagement in successful quality improvement initiatives in the ICU. We review the evidence supporting the impact of safety culture and provide practical guidance for those wishing to implement initiatives aimed at improving safety culture and more effectively integrate patients and families in such efforts. Literature review using PubMed including evaluation of key studies assessing large-scale quality improvement efforts in the ICU, impact of safety culture on patient outcomes, methodologies for quality improvement commonly used in healthcare, and patient and family engagement. Print and web-based resources from leading patient safety organizations were also searched. Our group completed a review of original studies, review articles, book chapters, and recommendations from leading patient safety organizations. Our group determined by consensus which resources would best inform this review. A strong safety culture is associated with reduced adverse events, lower mortality rates, and lower costs. Quality improvement efforts have been shown to be more effective and sustainable when paired with a strong safety culture. Different methodologies exist for quality improvement in the ICU; a thoughtful approach to implementation that engages frontline providers and administrative leadership is essential for success. Efforts to substantively include patients and families in the processes of quality improvement work in the ICU should be expanded. Efforts to establish a culture of safety and meaningfully engage patients and families should form the foundation for all safety interventions in the ICU. This review describes an approach that integrates components of several proven quality improvement methodologies to enhance safety culture in the ICU and highlights opportunities to include patients and families.

Advanced Guidance and Control Project for Reusable Launch Vehicles

NASA Technical Reports Server (NTRS)

Hanson, John M.

2000-01-01

The goals of this project are to significantly reduce the time and cost associated with guidance and control design for reusable launch vehicles, and to increase their safety and reliability. Success will lead to reduced cycle times during vehicle design and to reduced costs associated with flying to new orbits, with new payloads, and with modified vehicles. Success will also lead to more robustness to unforeseen circumstances in flight thereby enhancing safety and reducing risk. There are many guidance and control methods available that hold some promise for improvement in the desired areas. Investigators are developing a representative set of independent guidance and control methods for this project. These methods are being incorporated into a high-fidelity off is being conducted across a broad range of flight requirements. The guidance and control methods that perform the best will have demonstrated the desired qualities.

Driving Control for Electric Power Assisted Wheelchair Based on Regenerative Brake

NASA Astrophysics Data System (ADS)

Seki, Hirokazu; Takahashi, Kazuki; Tadakuma, Susumu

This paper describes a novel safety driving control scheme for electric power assisted wheelchairs based on the regenerative braking system. “Electric power assisted wheelchair” which assists the driving force by electric motors is expected to be widely used as a mobility support system for elderly people and disabled people, however, the safe and secure driving performance especially on downhill roads must be further improved because electric power assisted wheelchairs have no braking devices. The proposed control system automatically switches the driving mode, from “assisting mode” to “braking mode”, based on the wheelchair's velocity and the declined angle and smoothly suppresses the wheelchair's acceleration based on variable duty ratio control in order to realize the safety driving and to improve the ride quality. Some experiments on the practical roads and subjective evaluation show the effectiveness of the proposed control system.

John M. Eisenberg Patient Safety and Quality Awards.

PubMed

2009-12-01

The Joint Commission Journal on Quality and Patient Safety is honored to publish articles on the recipients of the annual John M. Eisenberg Patient Safety and Quality Awards. This year, a new category was created: individual achievement at the international level.

Power Extension Package (PEP) system definition extension, orbital service module systems analysis study. Volume 10: PEP project plan

NASA Technical Reports Server (NTRS)

1979-01-01

Contents: project plan summary; project and mission objectives; related studies and technology support activities; technical summary; management; procurement approach; project definition items and schedule; resources; management review; controlled items; and safety, reliability, and quality assurance.

Highway Safety Data : costs, quality, and strategies for improvement : final report

DOT National Transportation Integrated Search

1978-05-01

The objective of the experiment is to establish the influence of various types of trucks, buses and recreational vehicles on traffic flow on rural non-controlled access highways. This influence is due primarily to the low speeds which are common for ...

Improving resident engagement in quality improvement and patient safety initiatives at the bedside: the Advocate for Clinical Education (ACE).

PubMed

Schleyer, Anneliese M; Best, Jennifer A; McIntyre, Lisa K; Ehrmantraut, Ross; Calver, Patty; Goss, J Richard

2013-01-01

Quality improvement (QI) and patient safety (PS) are essential competencies in residency training; however, the most effective means to engage physicians remains unclear. The authors surveyed all medicine and surgery physicians at their institution to describe QI/PS practices and concurrently implemented the Advocate for Clinical Education (ACE) program to determine if a physician-centered program in the context of educational structures and at the point of care improved performance. The ACE rounded with medicine and surgery teams and provided individual and team-level education and feedback targeting 4 domains: professionalism, infection control, interpreter use, and pain assessment. In a pilot, the ACE observed 2862 physician-patient interactions and 178 physicians. Self-reported compliance often was greater than the behaviors observed. Following ACE implementation, observed professionalism behaviors trended toward improvement; infection control also improved. Physicians were highly satisfied with the program. The ACE initiative is one coaching/feedback model for engaging residents in QI/PS that may warrant further study.

Enhancing the usability of CRT displays in test flight monitoring

NASA Astrophysics Data System (ADS)

Granaas, Michael M.; Sredinski, Victoria E.

1991-01-01

Enhancing the usability of Mission Control Center (MCC) CRT displays stands to improve the quality, productivity, and safety of flight-test research at the NASA Ames-Dryden Flight Research Facility. The results of this research suggests that much can be done to assist the user and improve the quality of flight research through the enhancement of current displays. This research has applications to a variety of flight data monitoring displays.

Quality and safety in medical care: what does the future hold?

PubMed

Liang, Bryan A; Mackey, Tim

2011-11-01

The rapid changes in health care policy, embracing quality and safety mandates, have culminated in programs and initiatives under the Patient Protection and Affordable Care Act. To review the context of, and anticipated quality and patient safety mandates for, delivery systems, incentives under health care reform, and models for future accountability for outcomes of care. Assessment of the provisions of Patient Protection and Affordable Care Act, other reform efforts, and reform initiatives focusing on future quality and safety provisions for health care providers. Health care reform and other efforts focus on consumerism in the context of price. Quality and safety efforts will be structured using financial incentives, best-practices research, and new delivery models that focus on reaching benchmarks while reducing costs. In addition, patient experience will be a key component of reimbursement, and a move toward "retail" approaches directed at the individual patient may supplant traditional "wholesale" efforts at attracting employers. Quality and safety have always been of prime importance in medicine. However, in the future, under health care reform and associated initiatives, a shift in the paradigm of medicine will integrate quality and safety measurement with financial incentives and a new emphasis on consumerism.

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

Fundamentals of quality and safety in diagnostic radiology.

PubMed

Bruno, Michael A; Nagy, Paul

2014-12-01

The most fundamental aspects of quality and safety in radiology are reviewed, including a brief history of the quality and safety movement as applied to radiology, the overarching considerations of organizational culture, team building, choosing appropriate goals and metrics, and the radiologist's quality "tool kit." Copyright © 2014 American College of Radiology. Published by Elsevier Inc. All rights reserved.

[Influence of Moxa Smoke on Indoor Air Quality and Strategies for Its Control].

PubMed

Yu, Chang; Wu, Qiao-Feng; Tang, Yong; Yu, Shu-Guang

2018-02-25

Moxibustion is an effective therapy for treatment of a lot of clinical problems, but the ignited moxa-induced smoke containing harmful substances may bring about indoor air pollution to affect both patients' and medical workers' health. However, there is no standards about controlling indoor air quality (IAQ) for moxibustion rooms in China. In the present study, the authors reviewed newly-published articles about some substances released from moxa smoke as inhalable particles (PM 10 and PM 2.5), formaldehyde, benzene, methylbenzene, xylene, bene[α]pyrene, total volatile organic compounds, CO, CO 2 , NO, SO 2 , NH 3 , O 3 , etc. some of which affect IAQ. On this account, the authors put forward some strategies for controlling IAQ in moxibustion clinics including setting united safe standards, enhancing ventilation, controlling moxibustion material quality and strengthening scientific research on the safety of moxa smoke control, fully playing the superiority of moxibustion therapy and reducing its unfavorable aspects in clinical practice in the future.

Quality and Safety as a Core Leadership Competency.

PubMed

Bleich, Michael R

2018-05-01

A leader's toolbox of competencies comprises knowledge, skills, and abilities in clinical care, finance, human resource management, and more. As essential as these are, a strong command of quality and safety competencies is sovereign in leading and managing, ensuring an optimal patient experience. Four core areas of quality and safety competencies are presented: systems science, knowledge workers, implementation science and big data, and quality safety tools and techniques. J Contin Educ Nurs. 2018;49(5):200-202. Copyright 2018, SLACK Incorporated.

Implementation Science: New Approaches to Integrating Quality and Safety Education for Nurses Competencies in Nursing Education.

PubMed

Dolansky, Mary A; Schexnayder, Julie; Patrician, Patricia A; Sales, Anne

Although quality and safety competencies were developed and disseminated nearly a decade ago by the Quality and Safety Education for Nurses (QSEN) project, the uptake in schools of nursing has been slow. The use of implementation science methods may be useful to accelerate quality and safety competency integration in nursing education. The article includes a definition and description of implementation science methods and practical implementation strategies for nurse educators to consider when integrating the QSEN competencies into nursing curriculum.

Optimizing Quality of Care and Patient Safety in Malaysia: The Current Global Initiatives, Gaps and Suggested Solutions.

PubMed

Jarrar, Mu'taman; Abdul Rahman, Hamzah; Don, Mohammad Sobri

2015-10-20

Demand for health care service has significantly increased, while the quality of healthcare and patient safety has become national and international priorities. This paper aims to identify the gaps and the current initiatives for optimizing the quality of care and patient safety in Malaysia. Review of the current literature. Highly cited articles were used as the basis to retrieve and review the current initiatives for optimizing the quality of care and patient safety. The country health plan of Ministry of Health (MOH) Malaysia and the MOH Malaysia Annual Reports were reviewed. The MOH has set four strategies for optimizing quality and sustaining quality of life. The 10th Malaysia Health Plan promotes the theme "1 Care for 1 Malaysia" in order to sustain the quality of care. Despite of these efforts, the total number of complaints received by the medico-legal section of the MOH Malaysia is increasing. The current global initiatives indicted that quality performance generally belong to three main categories: patient; staffing; and working environment related factors. There is no single intervention for optimizing quality of care to maintain patient safety. Multidimensional efforts and interventions are recommended in order to optimize the quality of care and patient safety in Malaysia.

Optimizing Quality of Care and Patient Safety in Malaysia: The Current Global Initiatives, Gaps and Suggested Solutions

PubMed Central

Jarrar, Mu’taman; Rahman, Hamzah Abdul; Don, Mohammad Sobri

2016-01-01

Background and Objective: Demand for health care service has significantly increased, while the quality of healthcare and patient safety has become national and international priorities. This paper aims to identify the gaps and the current initiatives for optimizing the quality of care and patient safety in Malaysia. Design: Review of the current literature. Highly cited articles were used as the basis to retrieve and review the current initiatives for optimizing the quality of care and patient safety. The country health plan of Ministry of Health (MOH) Malaysia and the MOH Malaysia Annual Reports were reviewed. Results: The MOH has set four strategies for optimizing quality and sustaining quality of life. The 10th Malaysia Health Plan promotes the theme “1 Care for 1 Malaysia” in order to sustain the quality of care. Despite of these efforts, the total number of complaints received by the medico-legal section of the MOH Malaysia is increasing. The current global initiatives indicted that quality performance generally belong to three main categories: patient; staffing; and working environment related factors. Conclusions: There is no single intervention for optimizing quality of care to maintain patient safety. Multidimensional efforts and interventions are recommended in order to optimize the quality of care and patient safety in Malaysia. PMID:26755459

Quality, risk management and patient safety: the challenge of effective integration.

PubMed

França, Margarida

2008-01-01

Nowadays we observe the development of three waves of intervention and change within healthcare services: quality management, risk management and patient safety. The Patient Safety movement has been launched at international level as a consequence of the Institute of Medicine's report--To Err is Human, and today patient safety constitutes one basic dimension of health quality subjected to the direct intervention of supranational entities (WHO, EU) and Member States' Governments. The objective of this paper is to raise awareness about the value of quality improvement (QI) methodologies and tools to sustainable healthcare quality outcomes.

Preventing and controlling foodborne disease in commercial and institutional food service settings: a systematic review of published intervention studies.

PubMed

Viator, Catherine; Blitstein, Jonathan; Brophy, Jenna E; Fraser, Angela

2015-02-01

This study reviews the current literature on behavioral and environmental food safety interventions conducted in commercial and institutional food service settings. A systematic search of the published literature yielded 268 candidate articles, from which a set of 23 articles reporting intervention outcomes was retained for evaluation. A categorization of measured outcomes is reported; studies addressed multiple outcomes ranging from knowledge, attitudes, and behavior of personal hygiene and food safety to management practices and disease rates and outbreaks. This study also investigates the quality of reported research methods used to evaluate the effectiveness of the interventions, using a nine-point quality index adapted by the authors. The observed scores suggest that there are opportunities to improve the design and reporting of research in the field of foodborne disease prevention as it applies to food safety interventions that target the food service industry. The aim is to aid researchers in this area to design higher quality studies and to produce clearer and more useful reports of their research. In turn, this can help to create a more complete evidence base that can be used to continually improve interventions in this domain.

Effects of nursing unit spatial layout on nursing team communication patterns, quality of care, and patient safety.

PubMed

Hua, Ying; Becker, Franklin; Wurmser, Teri; Bliss-Holtz, Jane; Hedges, Christine

2012-01-01

Studies investigating factors contributing to improved quality of care have found that effective team member communication is among the most critical and influential aspects in the delivery of quality care. Relatively little research has examined the role of the physical design of nursing units on communication patterns among care providers. Although the concept of decentralized unit design is intended to increase patient safety, reduce nurse fatigue, and control the noisy, chaotic, and crowded space associated with centralized nursing stations, until recently little attention has been paid to how such nursing unit designs affected communication patterns or other medical and organizational outcomes. Using a pre/post research design comparing more centralized or decentralized unit designs with a new multi-hub design, the aim of this study was to describe the relationship between the clinical spatial environment and its effect on communication patterns, nurse satisfaction, distance walked, organizational outcomes, patient safety, and patient satisfaction. Hospital institutional data indicated that patient satisfaction increased substantially. Few significant changes were found in communication patterns; no significant changes were found in nurse job satisfaction, patient falls, pressure ulcers, or organizational outcomes such as average length of stay or patient census.

ASAS Centennial Paper: Developments and future outlook for preharvest food safety.

PubMed

Oliver, S P; Patel, D A; Callaway, T R; Torrence, M E

2009-01-01

The last century of food animal agriculture is a remarkable triumph of scientific research. Knowledge derived through research has resulted in the development and use of new technologies that have increased the efficiency of food production and created a huge animal production and food manufacturing industry capable of feeding the US population while also providing significant quantities of high-quality food for export to other countries. Although the US food supply is among the safest in the world, the US Center for Disease Prevention and Control estimates that 76 million people get sick, more than 300,000 are hospitalized, and 5,000 die each year from foodborne illness. Consequently, preventing foodborne illness and death remains a major public health concern. Challenges to providing a safe, abundant, and nutritious food supply are complex because all aspects of food production, from farm to fork, must be considered. Given the national and international demand and expectations for food safety as well as the formidable challenges of producing and maintaining a safe food supply, food safety research and educational programs have taken on a new urgency. Remarkable progress has been made during the last century. Wisdom from a century of animal agriculture research now includes the realization that on-farm pathogens are intricately associated with animal health and well-being, the production of high-quality food, and profitability. In this review, some of the developments that have occurred over the last few decades are summarized, including types, sources, and concentrations of disease-causing pathogens encountered in food-producing animal environments and their association with food safety; current and future methods to control or reduce foodborne pathogens on the farm; and present and future preharvest food safety research directions. Future scientific breakthroughs will no doubt have a profound impact on animal agriculture and the production of high-quality food, but we will also be faced with moral, ethical, and societal dilemmas that must be reconciled. A strong, science-based approach that addresses all the complex issues involved in continuing to improve food safety and public health is necessary to prevent foodborne illnesses. Not only must research be conducted to solve complex food safety issues, but results of that research must also be communicated effectively to producers and consumers.

Improving Health Care Workers for Seasonal Influenza Vaccination at University Health System: A Paradigm for Closing the Quality Chasm

PubMed Central

Patterson, Jan E.; Cadena, Jose; Prigmore, Teresa; Bowling, Jason; Ayala, Beth Ann; Kirkman, Leni; Parekh, Amruta; Scepanski, Theresa

2011-01-01

Significant gaps in quality and patient safety in the US health-care system have been identified and were reported in the past decade by the Institute of Medicine. Despite recognition of these gaps in “knowing versus doing,” change in health care is slow and difficult. The quality improvement and clinical safety movement is increasing among US medical centers. Our health science center implemented the UT System Clinical Safety and Effectiveness course, providing project-based teaching of quality-improvement tools and principles of patient safety. A quality-improvement project that increased healthcare workers' influenza vaccination rate by 17.8% from that in 2008 to a rate of 76.6% in 2009 serves as a paradigm of how physicians can lead quality-improvement project teams to narrow the quality chasm (1). Local efforts to narrow the chasm are discussed in the present paper, including inter-professional education in quality improvement and clinical safety. PMID:21686222

30 CFR 250.806 - Safety and pollution prevention equipment quality assurance requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 2 2010-07-01 2010-07-01 false Safety and pollution prevention equipment... Gas Production Safety Systems § 250.806 Safety and pollution prevention equipment quality assurance... install only certified safety and pollution prevention equipment (SPPE) in wells located on the OCS. SPPE...

Transformational Leadership: The Chief Nursing Officer Role in Leading Quality and Patient Safety.

PubMed

Jones, Pam; Polancich, Shea; Steaban, Robin; Feistritzer, Nancye; Poe, Terri

This department column highlights leadership perspectives of quality and patient safety practice. The purpose of this article is to provide strategic direction for transformational quality and safety leadership as the chief nursing officer (CNO) within the academic medical center environment.

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

PubMed

Dolansky, Mary A; Moore, Shirley M

2013-09-30

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

V&V Plan for FPGA-based ESF-CCS Using System Engineering Approach.

NASA Astrophysics Data System (ADS)

Maerani, Restu; Mayaka, Joyce; El Akrat, Mohamed; Cheon, Jung Jae

2018-02-01

Instrumentation and Control (I&C) systems play an important role in maintaining the safety of Nuclear Power Plant (NPP) operation. However, most current I&C safety systems are based on Programmable Logic Controller (PLC) hardware, which is difficult to verify and validate, and is susceptible to software common cause failure. Therefore, a plan for the replacement of the PLC-based safety systems, such as the Engineered Safety Feature - Component Control System (ESF-CCS), with Field Programmable Gate Arrays (FPGA) is needed. By using a systems engineering approach, which ensures traceability in every phase of the life cycle, from system requirements, design implementation to verification and validation, the system development is guaranteed to be in line with the regulatory requirements. The Verification process will ensure that the customer and stakeholder’s needs are satisfied in a high quality, trustworthy, cost efficient and schedule compliant manner throughout a system’s entire life cycle. The benefit of the V&V plan is to ensure that the FPGA based ESF-CCS is correctly built, and to ensure that the measurement of performance indicators has positive feedback that “do we do the right thing” during the re-engineering process of the FPGA based ESF-CCS.

46 CFR 160.064-6 - Examinations, tests and inspections.

Code of Federal Regulations, 2010 CFR

2010-10-01

... labeled water safety buoyant devices shall maintain quality control of the materials used, manufacturing... available to the recognized laboratory inspector or to the Coast Guard marine inspector, or both, for review upon request. (b) Laboratory inspections and tests. Such examinations, inspections and tests as are...

Facilities Management: A Program for the 1980s.

ERIC Educational Resources Information Center

Kaiser, Harvey H.

1980-01-01

Successful facilities management is described as based on a 10-point comprehensive program including: (1) physical planning policy; (2) facilities analysis; (3) management audit; (4) space utilization; (5) capital programs; (6) deferred maintenance; (7) controlled maintenance; (8) energy conservation; (9) environmental quality, health, and safety;…

Radiology Technician (AFSC 90370).

ERIC Educational Resources Information Center

Sobczak, James

This five-volume student text is designed for use by Air Force personnel enrolled in a self-study extension course for radiology technicians. Covered in the individual volumes are radiographic fundamentals (x-ray production; primary beams; exposure devices; film, film holders, and darkrooms; control of film quality; and environmental safety);…

Raman imaging from microscopy to macroscopy: Quality and safety control of biological materials

USDA-ARS?s Scientific Manuscript database

Raman imaging can analyze biological materials by generating detailed chemical images. Over the last decade, tremendous advancements in Raman imaging and data analysis techniques have overcome problems such as long data acquisition and analysis times and poor sensitivity. This review article introdu...

77 FR 8884 - Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to a...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-15

... information (e.g., characterization, adventitious agent safety, process controls, and specifications) for the... Manufacturing Process Assessment of Physiochemical Properties Functional Activities Receptor Binding and... 351(k) application. FDA will also seek OMB approval for this information collection. In addition, this...

Intelligent walkers for the elderly: performance and safety testing of VA-PAMAID robotic walker.

PubMed

Rentschler, Andrew J; Cooper, Rory A; Blasch, Bruce; Boninger, Michael L

2003-01-01

A walker that could help navigate and avoid collisions with obstacles could help reduce health costs and increase the quality of care and independence of thousands of people. This study evaluated the safety and performance of the Veterans Affairs Personal Adaptive Mobility Aid (VA-PAMAID). We performed engineering tests on the VA-PAMAID to determine safety factors, including stability, energy consumption, fatigue life, and sensor and control malfunctions. The VA-PAMAID traveled 10.9 km on a full charge and avoided obstacles while traveling at a speed of up to 1.2 m/s. No failures occurred during static stability, climatic, or fatigue testing. Some problems were encountered during obstacle climbing and sensor and control testing. The VA-PAMAID has good range, has adequate reaction time, and is structurally sound. Clinical trials are planned to compare the device to other low-technical adaptive mobility devices.

WTEC monograph on instrumentation, control and safety systems of Canadian nuclear facilities

NASA Technical Reports Server (NTRS)

Uhrig, Robert E.; Carter, Richard J.

1993-01-01

This report updates a 1989-90 survey of advanced instrumentation and controls (I&C) technologies and associated human factors issues in the U.S. and Canadian nuclear industries carried out by a team from Oak Ridge National Laboratory (Carter and Uhrig 1990). The authors found that the most advanced I&C systems are in the Canadian CANDU plants, where the newest plant (Darlington) has digital systems in almost 100 percent of its control systems and in over 70 percent of its plant protection system. Increased emphasis on human factors and cognitive science in modern control rooms has resulted in a reduced workload for the operators and the elimination of many human errors. Automation implemented through digital instrumentation and control is effectively changing the role of the operator to that of a systems manager. The hypothesis that properly introducing digital systems increases safety is supported by the Canadian experience. The performance of these digital systems has been achieved using appropriate quality assurance programs for both hardware and software development. Recent regulatory authority review of the development of safety-critical software has resulted in the creation of isolated software modules with well defined interfaces and more formal structure in the software generation. The ability of digital systems to detect impending failures and initiate a fail-safe action is a significant safety issue that should be of special interest to nuclear utilities and regulatory authorities around the world.

Is there a relationship between high-quality performance in major teaching hospitals and residents' knowledge of quality and patient safety?

PubMed

Pingleton, Susan K; Horak, Bernard J; Davis, David A; Goldmann, Donald A; Keroack, Mark A; Dickler, Robert M

2009-11-01

The relationship of the quality of teaching hospitals' clinical performance to resident education in quality and patient safety is unclear. The authors studied residents' knowledge of these areas in major teaching hospitals with higher- and lower-quality performance rankings. They assessed the presence of formal and informal quality curricula to determine whether programmatic differences exist. The authors used qualitative research methodology with purposeful sampling. They gathered data from individual structured interviews with residents and key educational and quality leaders in six medical schools and teaching hospitals, which represented a range of quality performance rankings, geographic regions, and public or private status. No relationship emerged between a hospital's quality status, residents' curriculum, and the residents' understanding of quality. Residents' definitions of quality and safety and their knowledge of the practice-based learning and systems-based practice competencies were indistinguishable between hospitals. Residents in all programs had extensive patient safety knowledge acquired through an informal curriculum in the hospital setting. A formal curriculum existed in only two programs, both of them ambulatory settings. Residents' learning about quality and patient safety is extensive, largely through a positive informal curriculum in the teaching hospital and, less frequently, via a formal curriculum. No relationship was found between the quality performance of the teaching hospital and the residents' curriculum or understanding of quality or safety. Residents seem to learn through an informal curriculum provided by hospital initiatives and resources, and thus these data suggest the importance of major teaching hospitals in quality education.

Improving multiple sclerosis management and collecting safety information in the real world: the MSDS3D software approach.

PubMed

Haase, Rocco; Wunderlich, Maria; Dillenseger, Anja; Kern, Raimar; Akgün, Katja; Ziemssen, Tjalf

2018-04-01

For safety evaluation, randomized controlled trials (RCTs) are not fully able to identify rare adverse events. The richest source of safety data lies in the post-marketing phase. Real-world evidence (RWE) and observational studies are becoming increasingly popular because they reflect usefulness of drugs in real life and have the ability to discover uncommon or rare adverse drug reactions. Areas covered: Adding the documentation of psychological symptoms and other medical disciplines, the necessity for a complex documentation becomes apparent. The collection of high-quality data sets in clinical practice requires the use of special documentation software as the quality of data in RWE studies can be an issue in contrast to the data obtained from RCTs. The MSDS3D software combines documentation of patient data with patient management of patients with multiple sclerosis. Following a continuous development over several treatment-specific modules, we improved and expanded the realization of safety management in MSDS3D with regard to the characteristics of different treatments and populations. Expert opinion: eHealth-enhanced post-authorisation safety study may complete the fundamental quest of RWE for individually improved treatment decisions and balanced therapeutic risk assessment. MSDS3D is carefully designed to contribute to every single objective in this process.

[The Results of Self-Assessment by Medical Organizations Their Correspondence to Proposals (Practical Recommendations) of the Roszdravnadzor Concerning Organization of Internal Control of Quality and Safety of Medical Activity].

PubMed

Ivanov, I V; Shvabsky, O R; Minulin, I B

2017-11-01

The article presents the analysis of the results of internal audits (self-rating) in medical organizations implemented on the basis of Proposals (practical guidelines) of the Roszdravnadzor concerning organization of inner control of quality and safety of medical activities in medical organization (hospital). The self-rating was implemented by the medical organizations themselves according the common criteria of the Proposals as provided the following plan: planning of self-rating, collection and processing of data, application of self-rating, analysis of obtained results, preparation of report. The article uses the results of self-rating of medical organizations corresponding to following criteria: profile of activity-multi-field hospital-number of beds more than 350-state property. The self-rating was implemented according to 11 basic parts of the Proposals. The criteria were developed for every part. The evaluation lists developed on the basis of the given Proposals permitted to medical organizations to independently establish problems in their activities. Within the framework of implemented self-rating medical organizations mentioned the directions of activity related to personnel management, identification of personality of patient, support of epidemiological and surgical safety as having significant discrepancies with the Proposals and requiring implementation of improvement measures.

Development of the First World Health Organization Lentiviral Vector Standard: Toward the Production Control and Standardization of Lentivirus-Based Gene Therapy Products

PubMed Central

Zhao, Yuan; Stepto, Hannah; Schneider, Christian K

2017-01-01

Gene therapy is a rapidly evolving field. So far, there have been >2,400 gene therapy products in clinical trials and four products on the market. A prerequisite for producing gene therapy products is ensuring their quality and safety. This requires appropriately controlled and standardized production and testing procedures that result in consistent safety and efficacy. Assuring the quality and safety of lentivirus-based gene therapy products in particular presents a great challenge because they are cell-based multigene products that include viral and therapeutic proteins as well as modified cells. In addition to the continuous refinement of a product, changes in production sites and manufacturing processes have become more and more common, posing challenges to developers regarding reproducibility and comparability of results. This paper discusses the concept of developing a first World Health Organization International Standard, suitable for the standardization of assays and enabling comparison of cross-trial and cross-manufacturing results for this important vector platform. The standard will be expected to optimize the development of gene therapy medicinal products, which is especially important, given the usually orphan nature of the diseases to be treated, naturally hampering reproducibility and comparability of results. PMID:28747142

Green lasers are beyond power limits mandated by safety standards.

PubMed

Lee, M H; Fox, K; Goldwasser, S; Lau, D W M; Aliahmad, B; Sarossy, M

2016-08-01

There has been an increasing number of reports of people losing vision from laser exposure from pocket laser pointers despite the safety limit of 1 milliwatt (1mW) imposed by the Australian government. We hypothesize that this is because commercially available red and green laser pointers are exceeding their labeled power outputs. We tested the power outputs of 4 red and 4 green lasers which were purchased for less than AUD$30 each. The average of 10 measurements was recorded for each laser. We found that 3 out of 4 red lasers conformed to the 1mW safety standard; in contrast, all of the green lasers exceeded this limit, with one of the lasers recording an output of 127.9 mW. This contrast in compliance is explained by the construction of these lasers - green lasers are typically Diode Pumped Solid State (DPSS) lasers that can emit excessive infrared (IR) radiation with poor workmanship or inconsistent adherence to practices of safe design and quality control; red lasers are diode lasers which have limited power outputs due to `Catastrophic Optical Damage' (COD). Relevant professional bodies ought to advocate more strongly for stringent testing, quality control and licensing of DPSS lasers with a view towards government intervention to banning green laser pointer use.

Meditation for posttraumatic stress: Systematic review and meta-analysis.

PubMed

Hilton, Lara; Maher, Alicia Ruelaz; Colaiaco, Benjamin; Apaydin, Eric; Sorbero, Melony E; Booth, Marika; Shanman, Roberta M; Hempel, Susanne

2017-07-01

We conducted a systematic review and meta-analysis that synthesized evidence from randomized controlled trials of meditation interventions to provide estimates of their efficacy and safety in treating adults diagnosed with posttraumatic stress disorder (PTSD). This review was based on an established protocol (PROSPERO: CRD42015025782) and is reported according to PRISMA guidelines. Outcomes of interest included PTSD symptoms, depression, anxiety, health-related quality of life, functional status, and adverse events. Meta-analyses were conducted using the Hartung-Knapp-Sidik-Jonkman method for random-effects models. Quality of evidence was assessed using the Grade of Recommendations Assessment, Development, and Evaluation (GRADE) approach. In total, 10 trials on meditation interventions for PTSD with 643 participants met inclusion criteria. Across interventions, adjunctive meditation interventions of mindfulness-based stress reduction, yoga, and the mantram repetition program improve PTSD and depression symptoms compared with control groups, but the findings are based on low and moderate quality of evidence. Effects were positive but not statistically significant for quality of life and anxiety, and no studies addressed functional status. The variety of meditation intervention types, the short follow-up times, and the quality of studies limited analyses. No adverse events were reported in the included studies; only half of the studies reported on safety. Meditation appears to be effective for PTSD and depression symptoms, but in order to increase confidence in findings, more high-quality studies are needed on meditation as adjunctive treatment with PTSD-diagnosed participant samples large enough to detect statistical differences in outcomes. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

The impact of biopreservatives and storage temperature in the quality and safety of minimally processed mixed vegetables for soup.

PubMed

Alvarez, María V; Ponce, Alejandra G; Mazzucotelli, Cintia A; Moreira, María R

2015-03-30

The combined effects of bioactive agents (tea tree essential oil, propolis extract and gallic acid) and storage temperature on the microbiological and sensory quality of fresh-cut mixed vegetables for soup (celery, leek and butternut squash) were studied with the objective of preserving its quality and safety. Refrigeration temperature was confirmed as the main factor to limit the growth of spoilage and pathogenic microorganisms. Biopreservatives applied on mixed vegetables were effective only when combined with optimal refrigeration temperature (5 °C). Bioactive compounds showed slight effectiveness in controlling the microbiota present in mixed vegetables, although coliforms were greatly reduced by gallic acid and propolis treatments, achieving 0.5-2 log unit reductions during storage. Also, these agents showed antimicrobial activity against endogenous Escherichia coli and inoculated E. coli O157:H7, exerting a bacteriostatic effect and reducing population counts by 0.9-1.2 log CFU g(-1) at 10 days of refrigerated storage. The combination of propolis treatment with refrigerated storage conditions effectively preserved the sensory quality and prolonged the sensory shelf life of fresh-cut mixed vegetables by 3 days. The use of natural agents such as propolis extract to preserve the quality and safety of mixed vegetables for soup might be an interesting option to address the concerns of the consumer about the use of synthetic chemical antimicrobials potentially harmful to health. © 2014 Society of Chemical Industry.

Dynamics, stability, and control of maglev systems

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

Cai, Y.; Chen, S.S.; Rote, D.M.

1993-06-01

The dynamic response of maglev systems is important in several respects: Safety and ride quality, guideway design, and system costs. The dynamic response of vehicles is the key element in the determination of ride quality, and vehicle stability is one of the important elements relative to safety. To design a proper guideway that provides acceptable ride quality in the stable region, the vehicle dynamics must be understood. The trade-off between guideway smoothness and the levitation and control systems must be considered if maglev systems are to be economically feasible. This paper is a summary of our previous work on dynamics,more » stability and control of maglev systems. First of all, the importance of dynamics of vehicle/guideway of maglev systems is discussed. Emphasis is placed on the modeling vehicle/guideway interactions of maglev systems with a multicar, or multiload vehicle traversing on a single or double-span flexible guideway. Coupled effects of vehicle/guideway interactions in wide range of vehicle speeds with various vehicle and guideway parameters for maglev systems are investigated. Secondly, the alternative control designs of maglev vehicle suspension systems are investigated in this study to achieve safe, stable operation and acceptable ride comfort requires some form of vehicle motion control. Active and semi-active control law designs are introduced into primary and secondary suspensions of maglev vehicles. Finally, this paper discusses the stability of maglev systems based on experimental data, scoping calculations, and simple mathematical models. Divergence and flutter are obtained for coupled vibration of a three-degree-of-freedom maglev vehicle on a guideway consisting of double L-shaped aluminum segments. The theory and analysis developed in this study provides basic stability characteristics and identifies future research needs for maglev systems.« less

Dynamics, stability, and control of maglev systems

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

Cai, Y.; Chen, S.S.; Rote, D.M.

1993-01-01

The dynamic response of maglev systems is important in several respects: Safety and ride quality, guideway design, and system costs. The dynamic response of vehicles is the key element in the determination of ride quality, and vehicle stability is one of the important elements relative to safety. To design a proper guideway that provides acceptable ride quality in the stable region, the vehicle dynamics must be understood. The trade-off between guideway smoothness and the levitation and control systems must be considered if maglev systems are to be economically feasible. This paper is a summary of our previous work on dynamics,more » stability and control of maglev systems. First of all, the importance of dynamics of vehicle/guideway of maglev systems is discussed. Emphasis is placed on the modeling vehicle/guideway interactions of maglev systems with a multicar, or multiload vehicle traversing on a single or double-span flexible guideway. Coupled effects of vehicle/guideway interactions in wide range of vehicle speeds with various vehicle and guideway parameters for maglev systems are investigated. Secondly, the alternative control designs of maglev vehicle suspension systems are investigated in this study to achieve safe, stable operation and acceptable ride comfort requires some form of vehicle motion control. Active and semi-active control law designs are introduced into primary and secondary suspensions of maglev vehicles. Finally, this paper discusses the stability of maglev systems based on experimental data, scoping calculations, and simple mathematical models. Divergence and flutter are obtained for coupled vibration of a three-degree-of-freedom maglev vehicle on a guideway consisting of double L-shaped aluminum segments. The theory and analysis developed in this study provides basic stability characteristics and identifies future research needs for maglev systems.« less

Implementation and implication of total quality management on client- contractor relationship in residential projects

NASA Astrophysics Data System (ADS)

Murali, Swetha; Ponmalar, V.

2017-07-01

To make innovation and continuous improvement as a norm, some traditional practices must become unlearnt. Change for growth and competitiveness are required for sustainability for any profitable business such as the construction industry. The leading companies are willing to implement Total Quality Management (TQM) principles, to realise potential advantages and improve growth and efficiency. Ironically, researches recollected quality as the most significant provider for competitive advantage in industrial leadership. The two objectives of this paper are 1) Identify TQM effectiveness in residential projects and 2) Identify the client satisfaction/dissatisfaction areas using Analytical Hierarchy Process (AHP) and suggest effective mitigate measures. Using statistical survey techniques like set of questionnaire survey, it is observed that total quality management was applied in some leading successful organization to an extent. The main attributes for quality achievement can be defined as teamwork and better communication with single agreed goal between client and contractor. Onsite safety is a paramount attribute in the identifying quality within the residential projects. It was noticed that the process based quality methods such as onsite safe working condition; safe management system and modern engineering process safety controls etc. as interlinked functions. Training and effective communication with all stakeholders on quality management principles is essential for effective quality work. Late Only through effective TQM principles companies can avoid some contract litigations with an increased client satisfaction Index.

Provoking "Eureka" moments for effective infection control strategies.

PubMed

Pittet, Didier

2014-01-01

Safety is now a fundamental principle of patient care and a critical component of quality management. Health care-associated infection prevention strategies need to be constantly revisited and updated to be effective. The "Geneva hand hygiene model" is a typical example of a breakthrough innovatory campaign that caught fire and went viral worldwide, thanks to its adoption by the World Health Organization (WHO) as the First Global Patient Safety Challenge. The campaign remains an inspiration for further innovation. To encourage new and disruptive technologies with the potential to improve patient safety through the successful implementation of the WHO multimodal strategy, the University of Geneva Hospitals/WHO Collaborating Centre on Patient Safety, together with the Aesculap Academy, have created a series of "Hand Hygiene Excellence Awards" and "Hand Hygiene Innovation Awards" worldwide.

Assessing the influence of component processing and donor characteristics on quality of red cell concentrates using quality control data.

PubMed

Jordan, A; Chen, D; Yi, Q-L; Kanias, T; Gladwin, M T; Acker, J P

2016-07-01

Quality control (QC) data collected by blood services are used to monitor production and to ensure compliance with regulatory standards. We demonstrate how analysis of quality control data can be used to highlight the sources of variability within red cell concentrates (RCCs). We merged Canadian Blood Services QC data with manufacturing and donor records for 28 227 RCC between June 2011 and October 2014. Units were categorized based on processing method, bag manufacturer, donor age and donor sex, then assessed based on product characteristics: haemolysis and haemoglobin levels, unit volume, leucocyte count and haematocrit. Buffy-coat method (top/bottom)-processed units exhibited lower haemolysis than units processed using the whole-blood filtration method (top/top). Units from female donors exhibited lower haemolysis than male donations. Processing method influenced unit volume and the ratio of additive solution to residual plasma. Stored red blood cell characteristics are influenced by prestorage processing and donor factors. Understanding the relationship between processing, donors and RCC quality will help blood services to ensure the safety of transfused products. © 2016 International Society of Blood Transfusion.

38 CFR 17.155 - Minimum standards of safety and quality for automotive adaptive equipment.

Code of Federal Regulations, 2012 CFR

2012-07-01

... safety and quality for automotive adaptive equipment. 17.155 Section 17.155 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS MEDICAL Automotive Equipment and Driver Training § 17.155 Minimum standards of safety and quality for automotive adaptive equipment. (a) The Under Secretary for...

38 CFR 17.155 - Minimum standards of safety and quality for automotive adaptive equipment.

Code of Federal Regulations, 2014 CFR

2014-07-01

... safety and quality for automotive adaptive equipment. 17.155 Section 17.155 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS MEDICAL Automotive Equipment and Driver Training § 17.155 Minimum standards of safety and quality for automotive adaptive equipment. (a) The Under Secretary for...

38 CFR 17.155 - Minimum standards of safety and quality for automotive adaptive equipment.

Code of Federal Regulations, 2011 CFR

2011-07-01

... safety and quality for automotive adaptive equipment. 17.155 Section 17.155 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS MEDICAL Automotive Equipment and Driver Training § 17.155 Minimum standards of safety and quality for automotive adaptive equipment. (a) The Under Secretary for...

38 CFR 17.155 - Minimum standards of safety and quality for automotive adaptive equipment.

Code of Federal Regulations, 2013 CFR

2013-07-01

... safety and quality for automotive adaptive equipment. 17.155 Section 17.155 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS MEDICAL Automotive Equipment and Driver Training § 17.155 Minimum standards of safety and quality for automotive adaptive equipment. (a) The Under Secretary for...

Safety, reliability, maintainability and quality provisions for the Space Shuttle program

NASA Technical Reports Server (NTRS)

1990-01-01

This publication establishes common safety, reliability, maintainability and quality provisions for the Space Shuttle Program. NASA Centers shall use this publication both as the basis for negotiating safety, reliability, maintainability and quality requirements with Shuttle Program contractors and as the guideline for conduct of program safety, reliability, maintainability and quality activities at the Centers. Centers shall assure that applicable provisions of the publication are imposed in lower tier contracts. Centers shall give due regard to other Space Shuttle Program planning in order to provide an integrated total Space Shuttle Program activity. In the implementation of safety, reliability, maintainability and quality activities, consideration shall be given to hardware complexity, supplier experience, state of hardware development, unit cost, and hardware use. The approach and methods for contractor implementation shall be described in the contractors safety, reliability, maintainability and quality plans. This publication incorporates provisions of NASA documents: NHB 1700.1 'NASA Safety Manual, Vol. 1'; NHB 5300.4(IA), 'Reliability Program Provisions for Aeronautical and Space System Contractors'; and NHB 5300.4(1B), 'Quality Program Provisions for Aeronautical and Space System Contractors'. It has been tailored from the above documents based on experience in other programs. It is intended that this publication be reviewed and revised, as appropriate, to reflect new experience and to assure continuing viability.

Requirements for modeling airborne microbial contamination in space stations

NASA Astrophysics Data System (ADS)

Van Houdt, Rob; Kokkonen, Eero; Lehtimäki, Matti; Pasanen, Pertti; Leys, Natalie; Kulmala, Ilpo

2018-03-01

Exposure to bioaerosols is one of the facets that affect indoor air quality, especially for people living in densely populated or confined habitats, and is associated to a wide range of health effects. Good indoor air quality is thus vital and a prerequisite for fully confined environments such as space habitats. Bioaerosols and microbial contamination in these confined space stations can have significant health impacts, considering the unique prevailing conditions and constraints of such habitats. Therefore, biocontamination in space stations is strictly monitored and controlled to ensure crew and mission safety. However, efficient bioaerosol control measures rely on solid understanding and knowledge on how these bioaerosols are created and dispersed, and which factors affect the survivability of the associated microorganisms. Here we review the current knowledge gained from relevant studies in this wide and multidisciplinary area of bioaerosol dispersion modeling and biological indoor air quality control, specifically taking into account the specific space conditions.

The Effect of Line Maintenance Activity on Airline Safety Quality

NASA Technical Reports Server (NTRS)

Rhoades, Dawna L.; Reynolds, Rosemarie; Waguespack, Blaise, Jr.; Williams, Michael

2005-01-01

One of the arguments against deregulation of the airline industry has been the possibility that financially troubled carriers would be tempted to lower line maintenance spending, thus lowering maintenance quality and decreasing the overall safety of the carrier. Given the financial crisis triggered by the events of 9/11: it appears to be a good time to revisit this issue. This paper examines the quality of airline line maintenance activity and examines the impact of maintenance spending on maintenance quality and overall safety. Findings indicate that increased maintenance spending is associated with increased line maintenance activity and increased overall safety quality for the major U.S. carriers.

Assessments of the quality of randomized controlled trials published in International Journal of Urology from 1994 to 2011.

PubMed

Cho, Hee Ju; Chung, Jae Hoon; Jo, Jung Ki; Kang, Dong Hyuk; Cho, Jeong Man; Yoo, Tag Keun; Lee, Seung Wook

2013-12-01

Randomized controlled trials are one of the most reliable resources for assessing the effectiveness and safety of medical treatments. Low quality randomized controlled trials carry a large bias that can ultimately impair the reliability of their conclusions. The present study aimed to evaluate the quality of randomized controlled trials published in International Journal of Urology by using multiple quality assessment tools. Randomized controlled trials articles published in International Journal of Urology were found using the PubMed MEDLINE database, and qualitative analysis was carried out with three distinct assessment tools: the Jadad scale, the van Tulder scale and the Cochrane Collaboration Risk of Bias Tool. The quality of randomized controlled trials was analyzed by publication year, type of subjects, intervention, presence of funding and whether an institutional review board reviewed the study. A total of 68 randomized controlled trial articles were published among a total of 1399 original articles in International Journal of Urology. Among these randomized controlled trials, 10 (2.70%) were from 1994 to 1999, 23 (4.10%) were from 2000 to 2005 and 35 (4.00%) were from 2006 to 2011 (P = 0.494). On the assessment with the Jadad and van Tulder scale, the numbers and percentage of high quality randomized controlled trials increased over time. The studies that had institutional review board reviews, funding resources or that were carried out in multiple institutions had an increased percentage of high quality articles. The numbers and percentage of high-quality randomized controlled trials published in International Journal of Urology have increased over time. Furthermore, randomized controlled trials with funding resources, institutional review board reviews or carried out in multiple institutions have been found to be of higher quality compared with others not presenting these features. © 2013 The Japanese Urological Association.

Roadmap to an effective quality improvement and patient safety program implementation in a rural hospital setting.

PubMed

Ingabire, Willy; Reine, Petera M; Hedt-Gauthier, Bethany L; Hirschhorn, Lisa R; Kirk, Catherine M; Nahimana, Evrard; Nepomscene Uwiringiyemungu, Jean; Ndayisaba, Aphrodis; Manzi, Anatole

2015-12-01

Implementation lessons: (1) implementation of an effective quality improvement and patient safety program in a rural hospital setting requires collaboration between hospital leadership, Ministry of Health and other stakeholders. (2) Building Quality Improvement (QI) capacity to develop engaged QI teams supported by mentoring can improve quality and patient safety. Copyright © 2015 Elsevier Inc. All rights reserved.

Learning from high risk industries may not be straightforward: a qualitative study of the hierarchy of risk controls approach in healthcare.

PubMed

Liberati, Elisa G; Peerally, Mohammad Farhad; Dixon-Woods, Mary

2018-02-01

Though healthcare is often exhorted to learn from 'high-reliability' industries, adopting tools and techniques from those sectors may not be straightforward. We sought to examine the hierarchies of risk controls approach, used in high-risk industries to rank interventions according to supposed effectiveness in reducing risk, and widely advocated as appropriate for healthcare. Classification of risk controls proposed by clinical teams following proactive detection of hazards in their clinical systems. Classification was based on a widely used hierarchy of controls developed by the US National Institute for Occupational Safety and Health (NIOSH). A range of clinical settings in four English NHS hospitals. The four clinical teams in our study planned a total of 42 risk controls aimed at addressing safety hazards. Most (n = 35) could be classed as administrative controls, thus qualifying among the weakest type of interventions according to the HoC approach. Six risk controls qualified as 'engineering' controls, i.e. the intermediate level of the hierarchy. Only risk control qualified as 'substitution', classified as the strongest type of intervention by the HoC. Many risk controls introduced by clinical teams may cluster towards the apparently weaker end of an established hierarchy of controls. Less clear is whether the HoC approach as currently formulated is useful for the specifics of healthcare. Valuable opportunities for safety improvement may be lost if inappropriate hierarchical models are used to guide the selection of patient safety improvement interventions. Though learning from other industries may be useful, caution is needed. © The Author(s) 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care.

Brave New Workplace: Technology and Work in the New Economy.

ERIC Educational Resources Information Center

Wallace, Michael

1989-01-01

Technological innovations in factories and offices are examined in terms of 10 core issues: "high flex" workplace; control of work; organizational change; impact on skill; unemployment; educational needs and retraining; changing occupational structures; safety and health; interaction of work, leisure, and family; and quality of working life. The…

78 FR 79465 - International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-30

... Essential Medicines and Health Products (EMP): http://www.who.int/medicines/areas/quality_safety/ECDD/en... medicine: --Please mention other, if any, medical use not included in the approved indications (off label...: (Controlled substances act/ Medicines law/Poisons acts/Consumer protection acts/Generic legislation/Analogue...

Optical spectroscopy for food and beverages control

NASA Astrophysics Data System (ADS)

Mignani, Anna Grazia; Ciaccheri, Leonardo; Mencaglia, Andrea Azelio

2011-08-01

A selection of spectroscopy-based, fiber optic and micro-optic devices is presented. They have been designed and tested for monitoring the quality and safety of typical foodstuffs. The VIS-NIR spectra, considered as product fingerprints, allowed to discriminating the geographic region of production and to detecting nutritional and nutraceutic indicators.

42 CFR 494.150 - Condition: Responsibilities of the medical director.

Code of Federal Regulations, 2011 CFR

2011-10-01

... admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients... responsible for the delivery of patient care and outcomes in the facility. The medical director is accountable to the governing body for the quality of medical care provided to patients. Medical director...

42 CFR 494.150 - Condition: Responsibilities of the medical director.

Code of Federal Regulations, 2010 CFR

2010-10-01

... admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients... responsible for the delivery of patient care and outcomes in the facility. The medical director is accountable to the governing body for the quality of medical care provided to patients. Medical director...

A Hardware-in-the-Loop Simulation Platform for the Verification and Validation of Safety Control Systems

NASA Astrophysics Data System (ADS)

Rankin, Drew J.; Jiang, Jin

2011-04-01

Verification and validation (V&V) of safety control system quality and performance is required prior to installing control system hardware within nuclear power plants (NPPs). Thus, the objective of the hardware-in-the-loop (HIL) platform introduced in this paper is to verify the functionality of these safety control systems. The developed platform provides a flexible simulated testing environment which enables synchronized coupling between the real and simulated world. Within the platform, National Instruments (NI) data acquisition (DAQ) hardware provides an interface between a programmable electronic system under test (SUT) and a simulation computer. Further, NI LabVIEW resides on this remote DAQ workstation for signal conversion and routing between Ethernet and standard industrial signals as well as for user interface. The platform is applied to the testing of a simplified implementation of Canadian Deuterium Uranium (CANDU) shutdown system no. 1 (SDS1) which monitors only the steam generator level of the simulated NPP. CANDU NPP simulation is performed on a Darlington NPP desktop training simulator provided by Ontario Power Generation (OPG). Simplified SDS1 logic is implemented on an Invensys Tricon v9 programmable logic controller (PLC) to test the performance of both the safety controller and the implemented logic. Prior to HIL simulation, platform availability of over 95% is achieved for the configuration used during the V&V of the PLC. Comparison of HIL simulation results to benchmark simulations shows good operational performance of the PLC following a postulated initiating event (PIE).

Promoting engagement by patients and families to reduce adverse events in acute care settings: a systematic review

PubMed Central

Berger, Zackary; Flickinger, Tabor E; Pfoh, Elizabeth; Martinez, Kathryn A; Dy, Sydney M

2014-01-01

Introduction Patient-centeredness is central to healthcare. Hospitals should address patients’ unique needs to improve safety and quality. Patient engagement in healthcare, which may help prevent adverse events, can be approached as an independent patient safety practice (PSP) or as part of a multifactorial PSP. Objectives This review examines how interventions encouraging this engagement have been implemented in controlled trials. Methods We searched Medline, CINAHL, Embase and Cochrane from 2000 to 2012 for English language studies in hospital settings with prospective controlled designs, addressing the effectiveness or implementation of patient/family engagement in PSPs. We separately reviewed interventions implemented as part of selected broader PSPs by way of example: hand hygiene, ventilator-associated pneumonia, rapid response systems and care transitions. Results Six articles met the inclusion criteria for effectiveness with a primary focus on patient engagement. We identified 12 studies implementing patient engagement as an aspect of selected broader PSPs. A number of studies relied on patients’ possible function as a reporter of error to healthcare workers and patients as a source of reminders regarding safety behaviours, while others relied on direct activation of patients or families. Definitions of patient and family engagement were lacking, as well as evidence regarding the types of patients who might feel comfortable engaging with providers, and in what contexts. Conclusions While patient engagement in safety is appealing, there is insufficient high-quality evidence informing real-world implementation. Further work should evaluate the effectiveness of interventions on patient and family engagement and clarify the added benefit of incorporating engagement in multifaceted approaches to improve patient safety endpoints. In addition, strategies to assess and overcome barriers to patients’ willingness to actively engage in their care should be investigated. PMID:24336575

The effects, safety and acceptability of compact, pre-filled, autodisable injection devices when delivered by lay health workers.

PubMed

Glenton, Claire; Khanna, Rajesh; Morgan, Chris; Nilsen, Elin Strømme

2013-08-01

To systematically assess (i) the effects and safety and (ii) the acceptability of using lay health workers (LHWs) to deliver vaccines and medicines to mothers and children through compact pre-filled autodisable devices (CPADs). We searched electronic databases and grey literature. For the systematic review of effects and safety, we sought randomised and non-randomised controlled trials, controlled before-after studies and interrupted time series studies. For the systematic review of acceptability, we sought qualitative studies. Two researchers independently carried out data extraction, study quality assessment and thematic analysis of the qualitative data. No studies met our criteria for the review exploring the effects and safety of using LHWs to deliver CPADs. For the acceptability review, six qualitative studies assessed the acceptability of using LHWs to deliver hepatitis B vaccine, tetanus toxoid vaccine, gentamicin or oxytocin using Uniject™ devices. All studies took place in low- or middle-income countries and explored the perceptions of community members, LHWs, supervisors, health professionals or programme managers. Most of the studies were of low quality. Recipients generally accepted the intervention. Most health professionals were confident that LHWs could deliver the intervention with sufficient training and supervision, but some had problems delivering supervision. The LHWs perceived Uniject™ as effective and important and were motivated by positive responses from the community. However, some LHWs feared the consequences if harm should come to recipients. Evidence of the effects and safety of using CPADs delivered by LHWs is lacking. Evidence regarding acceptability suggests that this intervention may be acceptable although LHWs may feel vulnerable to blame. © 2013 John Wiley & Sons Ltd.

Role of a quality management system in improving patient safety - laboratory aspects.

PubMed

Allen, Lynn C

2013-09-01

The aim of this study is to describe how implementation of a quality management system (QMS) based on ISO 15189 enhances patient safety. A literature review showed that several European hospitals implemented a QMS based on ISO 9001 and assessed the impact on patient safety. An Internet search showed that problems affecting patient safety have occurred in a number of laboratories across Canada. The requirements of a QMS based on ISO 15189 are outlined, and the impact of the implementation of each requirement on patient safety is summarized. The Quality Management Program - Laboratory Services in Ontario is briefly described, and the experience of Ontario laboratories with Ontario Laboratory Accreditation, based on ISO 15189, is outlined. Several hospitals that implemented ISO 9001 reported either a positive impact or no impact on patient safety. Patient safety problems in Canadian laboratories are described. Implementation of each requirement of the QMS can be seen to have a positive effect on patient safety. Average laboratory conformance on Ontario Laboratory Accreditation is very high, and laboratories must address and resolve any nonconformities. Other standards, practices, and quality requirements may also contribute to patient safety. Implementation of a QMS based on ISO 15189 provides a solid foundation for quality in the laboratory and enhances patient safety. It helps to prevent patient safety issues; when such issues do occur, effective processes are in place for investigation and resolution. Patient safety problems in Canadian laboratories might have been prevented had effective QMSs been in place. Ontario Laboratory Accreditation has had a positive impact on quality in Ontario laboratories. Copyright © 2013 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Current food safety management systems in fish-exporting companies require further improvements to adequately cope with contextual pressure: case study.

PubMed

Onjong, Hillary Adawo; Wangoh, John; Njage, Patrick Murigu Kamau

2014-10-01

Fish-processing plants still face food safety (FS) challenges worldwide despite the existence of several quality assurance standards and food safety management systems/s (FSMSs). This study assessed performance of FSMS in fish exporting sector considering pressure from the context in which they operate. A FSMS diagnostic tool with checklist was used to assess the context, FSMS, and FS output in 9 Kenyan fish exporting companies. Majority (67%) companies operated at moderate- to high-risk context but with an average performance in control and assurance activities. This situation could be insufficient to deal with ambiguity, uncertainty, and vulnerability issues in the context characteristics. Contextual risk posed by product characteristics (nature of raw materials) and chain environment characteristics was high. Risk posed by the chain environment characteristics, low power in supplier relationships, and low degree of authority in customer relationships was high. Lack of authority in relationship with suppliers would lead to high raw material risk situation. Even though cooling facilities, a key control activity, was at an advanced level, there was inadequate packaging intervention equipment which coupled with inadequate physical intervention equipment could lead to further weakened FSMS performance. For the fish companies to improve their FSMS to higher level and enhance predictability, they should base their FSMS on scientific information sources, historical results, and own experimental trials in their preventive, intervention, and monitoring systems. Specific suggestions are derived for improvements toward higher FSMS activity levels or lower risk levels in context characteristics. Weak areas in performance of control and assurance activities in export fish-processing sector already implementing current quality assurance guidelines and standards were studied taking into consideration contextual pressure wherein the companies operate. Important mitigation measures toward improved contextual risk, core assurance, and control activities irrespective of applied food safety management systems in fish industries were suggested. © 2014 Institute of Food Technologists®

Use of animals in the development and control of viral vaccines.

PubMed

Minor, P D

1996-01-01

Animal models were central to the development of poliovaccines and remain essential in some form in the routine quality control of both live and killed vaccines. The necessity of an animal model is illustrated by the examples of mumps and measles vaccines where the existing materials, while satisfactory, have a number of drawbacks and where changes in current practice raise concerns for safety and efficacy.

The Prevalence and Control of Bacillus and Related Spore-Forming Bacteria in the Dairy Industry.

PubMed

Gopal, Nidhi; Hill, Colin; Ross, Paul R; Beresford, Tom P; Fenelon, Mark A; Cotter, Paul D

2015-01-01

Milk produced in udder cells is sterile but due to its high nutrient content, it can be a good growth substrate for contaminating bacteria. The quality of milk is monitored via somatic cell counts and total bacterial counts, with prescribed regulatory limits to ensure quality and safety. Bacterial contaminants can cause disease, or spoilage of milk and its secondary products. Aerobic spore-forming bacteria, such as those from the genera Sporosarcina, Paenisporosarcina, Brevibacillus, Paenibacillus, Geobacillus and Bacillus, are a particular concern in this regard as they are able to survive industrial pasteurization and form biofilms within pipes and stainless steel equipment. These single or multiple-species biofilms become a reservoir of spoilage microorganisms and a cycle of contamination can be initiated. Indeed, previous studies have highlighted that these microorganisms are highly prevalent in dead ends, corners, cracks, crevices, gaskets, valves and the joints of stainless steel equipment used in the dairy manufacturing plants. Hence, adequate monitoring and control measures are essential to prevent spoilage and ensure consumer safety. Common controlling approaches include specific cleaning-in-place processes, chemical and biological biocides and other novel methods. In this review, we highlight the problems caused by these microorganisms, and discuss issues relating to their prevalence, monitoring thereof and control with respect to the dairy industry.

The Prevalence and Control of Bacillus and Related Spore-Forming Bacteria in the Dairy Industry

PubMed Central

Gopal, Nidhi; Hill, Colin; Ross, Paul R.; Beresford, Tom P.; Fenelon, Mark A.; Cotter, Paul D.

2015-01-01

Milk produced in udder cells is sterile but due to its high nutrient content, it can be a good growth substrate for contaminating bacteria. The quality of milk is monitored via somatic cell counts and total bacterial counts, with prescribed regulatory limits to ensure quality and safety. Bacterial contaminants can cause disease, or spoilage of milk and its secondary products. Aerobic spore-forming bacteria, such as those from the genera Sporosarcina, Paenisporosarcina, Brevibacillus, Paenibacillus, Geobacillus and Bacillus, are a particular concern in this regard as they are able to survive industrial pasteurization and form biofilms within pipes and stainless steel equipment. These single or multiple-species biofilms become a reservoir of spoilage microorganisms and a cycle of contamination can be initiated. Indeed, previous studies have highlighted that these microorganisms are highly prevalent in dead ends, corners, cracks, crevices, gaskets, valves and the joints of stainless steel equipment used in the dairy manufacturing plants. Hence, adequate monitoring and control measures are essential to prevent spoilage and ensure consumer safety. Common controlling approaches include specific cleaning-in-place processes, chemical and biological biocides and other novel methods. In this review, we highlight the problems caused by these microorganisms, and discuss issues relating to their prevalence, monitoring thereof and control with respect to the dairy industry. PMID:26733963

Food safety - the roles and responsibilities of different sectors

NASA Astrophysics Data System (ADS)

Karabasil, N.; Bošković, T.; Dimitrijević, M.; Vasilev, D.; Đorđević, V.; Lakićević, B.; Teodorović, V.

2017-09-01

Serbia is a relatively small country but with a long tradition in food production, especially meat and meat products. Serbia, as part of its open negotiation process as a candidate country with the European Union (EU), started to harmonise its legislation with the EU, and has published a set of laws and regulations relating to the hygiene of food production and food safety, the official control of production and the welfare of animals. Therefore, the food safety system in Serbia is based on principles established in the EU. There is a need for cooperation of different sectors (government, food business operators and consumers) in the management of food safety, and every sector has its role and responsibility. This paper aims to provide analytical support for the process of upgrading safety and quality in Serbia’s food sector and explains the roles and responsibilities of different sectors in the food chain.

Regulatory control of Chinese Proprietary Medicines in Singapore.

PubMed

Yee, Shen-Kuan; Chu, Swee-Seng; Xu, Yi-Min; Choo, Peck-Lin

2005-02-01

In Singapore, there has been a growing public interest in traditional Chinese medicine (TCM), which plays an important role in the healthcare system. With effect from 1 September 1999, the control on Chinese Proprietary Medicines (CPM) was implemented in three phases over a span of 3 years. Under the CPM regulatory framework, CPM importers, wholesalers, manufacturers and re-packers must be licensed and CPM products assessed and listed by the health authority before they are allowed for sale. Product assessment is based on the criteria of safety and quality which include limits of toxic heavy metals and microbial contents. During the 3-year CPM listing exercise, irregularities were detected, including intrinsic toxicity, adulteration, substitution, contamination, misidentification, non-traditional and/or inappropriate usage, incorrect preparation, inappropriate labelling, exaggerated claims and/or advertising. The full implementation of CPM control by September 2001 saw the listing of 7943 CPM products and brought about an improvement in the quality and safety of CPM in Singapore as well as the removal of sub-standard, fake/imitation and adulterated products. The standards of practices by local CPM dealers have also been raised. These improvements have, in turn, increased the level of public confidence in CPM products in Singapore.

Work organization and health among immigrant women: Latina manual workers in North Carolina.

PubMed

Arcury, Thomas A; Grzywacz, Joseph G; Chen, Haiying; Mora, Dana C; Quandt, Sara A

2014-12-01

We sought to describe work organization attributes for employed immigrant Latinas and determine associations of work organization with physical health, mental health, and health-related quality of life. We conducted a cross-sectional survey with 319 employed Latinas in western North Carolina (2009-2011). Measures included job demands (heavy load, awkward posture, psychological demand), decision latitude (skill variety, job control), support (supervisor control, safety climate), musculoskeletal symptoms, mental health (depressive symptoms), and mental (MCS) and physical component score (PCS) health-related quality of life. Three fifths reported musculoskeletal symptoms. Mean scores for depression, MCS, and PCS were 6.2 (SE = 0.2), 38.3 (SE = 0.5), and 42.8 (SE = 0.3), respectively. Greater job demands (heavy load, awkward posture, greater psychological demand) were associated with more musculoskeletal and depressive symptoms and worse MCS. Less decision latitude (lower skill variety, job control) was associated with more musculoskeletal and depressive symptoms. Greater support (supervisor's power and safety climate) was associated with fewer depressive symptoms and better MCS. Work organization should be considered to improve occupational health of vulnerable women workers. Additional research should delineate the links between work organization and health among vulnerable workers.

RN assessments of excellent quality of care and patient safety are associated with significantly lower odds of 30-day inpatient mortality: A national cross-sectional study of acute-care hospitals.

PubMed

Smeds-Alenius, Lisa; Tishelman, Carol; Lindqvist, Rikard; Runesdotter, Sara; McHugh, Matthew D

2016-09-01

Quality and safety in health care has been increasingly in focus during the past 10-15 years. Stakeholders actively discuss ways to measure safety and quality of care to improve the health care system as a whole. Defining and measuring quality and safety, however, is complicated. One underutilized resource worthy of further exploration is the use of registered nurses (RNs) as informants of overall quality of care and patient safety. However, research is still scarce or lacking regarding RN assessments of patient safety and quality of care and their relationship to objective patient outcomes. To investigate relationships between RN assessed quality of care and patient safety and 30-day inpatient mortality post-surgery in acute-care hospitals. This is a national cross-sectional study. A survey (n=>10,000 RNs); hospital organizational data (n=67); hospital discharge registry data (n>200,000 surgical patients). RN data derives from a national sample of RNs working directly with inpatient care in surgical/medical wards in acute-care hospitals in Sweden in 2010. Patient data are from the same hospitals in 2009-2010. Adjusted multivariate logistic regression models were used to estimate relationships between RN assessments and 30-day inpatient mortality. Patients cared for in hospitals where a high proportion of RNs reported excellent quality of care (the highest third of hospitals) had 23% lower odds of 30-day inpatient mortality compared to patients cared for in hospitals in the lowest third (OR 0.77, CI 0.65-0.91). Similarly, patients in hospitals where a high proportion of RNs reported excellent patient safety (highest third) had is 26% lower odds of death (OR 0.74, CI 0.60-0.91). RN assessed excellent patient safety and quality of care are related to significant reductions in odds of 30-day inpatient mortality, suggesting that positive RN reports of quality and safety can be valid indicators of these key variables. Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Developing a Practical and Sustainable Faculty Development Program With a Focus on Teaching Quality Improvement and Patient Safety: An Alliance for Independent Academic Medical Centers National Initiative III Project.

PubMed

Rodrigue, Christopher; Seoane, Leonardo; Gala, Rajiv B; Piazza, Janice; Amedee, Ronald G

2012-01-01

Teaching the next generation of physicians requires more than traditional teaching models. The Accreditation Council for Graduate Medical Education's Next Accreditation System places considerable emphasis on developing a learning environment that fosters resident education in quality improvement and patient safety. The goal of this project was to develop a comprehensive and sustainable faculty development program with a focus on teaching quality improvement and patient safety. A multidisciplinary team representing all stakeholders in graduate medical education developed a validated survey to assess faculty and house officer baseline perceptions of their experience with faculty development opportunities, quality improvement tools and training, and resident participation in quality improvement and patient safety programs at our institution. We then developed a curriculum to address these 3 areas. Our pilot survey revealed a need for a comprehensive program to teach faculty and residents the art of teaching. Two other areas of need are (1) regular resident participation in quality improvement and patient safety efforts and (2) effective tools for developing skills and habits to analyze practices using quality improvement methods. Resident and faculty pairs in 17 Ochsner training programs developed and began quality improvement projects while completing the first learning module. Resident and faculty teams also have been working on the patient safety modules and incorporating aspects of patient safety into their individual work environments. Our team's goal is to develop a sustainable and manageable faculty development program that includes modules addressing quality improvement and patient safety in accordance with Accreditation Council for Graduate Medical Education accreditation requirements.

78 FR 6819 - Patient Safety Organizations: Voluntary Relinquishment From The Connecticut Hospital Association...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-31

..., Center for Quality Improvement and Patient Safety, AHRQ, 540 Gaither Road, Rockville, MD 20850; Telephone... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety Organizations: Voluntary Relinquishment From The Connecticut Hospital Association Federal Patient Safety...

The quality and safety culture in general hospitals: patients', physicians' and nurses' evaluation of its effect on patient satisfaction.

PubMed

Kagan, Ilya; Porat, Nurit; Barnoy, Sivia

2018-06-21

To explore the disparities between patients' and health care workers' perception of the quality and safety culture and to explore the relationship between patient perceptions, and engagement in, and satisfaction with their care and treatment. A cross-sectional study was conducted in medical-surgical wards of four Israeli general hospitals. Data were collected using a self-administered questionnaire. Fourteen medical-surgical wards of the four hospitals where data were collected. The sample comprised of 390 physicians and nurses and 726 inpatients admitted for at least 3 days. A self-administered questionnaire that covered the following topics: (i) quality and safety culture, (ii) patient engagement, (iii) patient satisfaction, (iv) an assessment of the care quality and safety in the ward and (v) sociodemographic data. The questionnaire was translated into Arabic and Russian. Sixty nine items were directed to the staff and 71 to patients. Patients evaluated the quality and safety culture significantly higher than did the health care workers. Significant correlations were found between patients' engagement in and satisfaction with their care and their quality and safety assessments. Their evaluation of this culture was the only predictor of their satisfaction and engagement. Arabic-speaking patients rated four variables, including patients' satisfaction with their care, lower than did Hebrew and Russian speakers. Patients have sufficient experience and understanding to form an opinion of the quality and safety of their care. The lower evaluation of the quality and safety culture expressed by health care workers might stem from their more realistic expectations.

Understanding biomaterial-tissue interface quality: combined in vitro evaluation

NASA Astrophysics Data System (ADS)

Gasik, Michael

2017-12-01

One of the greatest challenges in the development of new medical products and devices remains in providing maximal patient safety, efficacy and suitability for the purpose. A 'good quality' of the tissue-implant interface is one of the most critical factors for the success of the implant integration. In this paper this challenge is being discussed from the point of view of basic stimuli combination to experimental testing. The focus is in particular on bacterial effects on tissue-implant interaction (for different materials). The demonstration of the experimental evaluation of the tissue-implant interface is for dental abutment with mucosal contact. This shows that testing of the interface quality could be the most relevant in controlled conditions, which mimic as possible the clinical applications, but consider variables being under the control of the evaluator.

42 CFR 418.58 - Condition of participation: Quality assessment and performance improvement.

Code of Federal Regulations, 2011 CFR

2011-10-01

... collected to do the following: (i) Monitor the effectiveness and safety of services and quality of care. (ii..., patient safety, and quality of care. (2) Performance improvement activities must track adverse patient... care and patient safety, and that all improvement actions are evaluated for effectiveness. (3) That one...

Line-scan Raman imaging and spectroscopy platform for surface and subsurface evaluation of food safety and quality

USDA-ARS?s Scientific Manuscript database

Both surface and subsurface food inspection is important since interesting safety and quality attributes can be at different sample locations. This paper presents a multipurpose line-scan Raman platform for food safety and quality research, which can be configured for Raman chemical imaging (RCI) mo...

A strategic approach to quality improvement and patient safety education and resident integration in a general surgery residency.

PubMed

O'Heron, Colette T; Jarman, Benjamin T

2014-01-01

To outline a structured approach for general surgery resident integration into institutional quality improvement and patient safety education and development. A strategic plan to address Accreditation Council for Graduate Medical Education (ACGME) Clinical Learning Environment Review assessments for resident integration into Quality Improvement and Patient Safety initiatives is described. Gundersen Lutheran Medical Foundation is an independent academic medical center graduating three categorical residents per year within an integrated multi-specialty health system serving 19 counties over 3 states. The quality improvement and patient safety education program includes a formal lecture series, online didactic sessions, mandatory quality improvement or patient safety projects, institutional committee membership, an opportunity to serve as a designated American College of Surgeons National Surgical Quality Improvement Project and Quality in Training representative, mandatory morbidity and mortality conference attendance and clinical electives in rural surgery and international settings. Structured education regarding and participation in quality improvement and patient safety programs are able to be accomplished during general surgery residency. The long-term outcomes and benefits of these strategies are unknown at this time and will be difficult to measure with objective data. © 2013 Published by Association of Program Directors in Surgery on behalf of Association of Program Directors in Surgery.

Impact of Performance Obstacles on Intensive Care Nurses‘ Workload, Perceived Quality and Safety of Care, and Quality of Working Life

PubMed Central

Gurses, Ayse P; Carayon, Pascale; Wall, Melanie

2009-01-01

Objectives To study the impact of performance obstacles on intensive care nurses‘ workload, quality and safety of care, and quality of working life (QWL). Performance obstacles are factors that hinder nurses‘ capacity to perform their job and that are closely associated with their immediate work system. Data Sources/Study Setting Data were collected from 265 nurses in 17 intensive care units (ICUs) between February and August 2004 via a structured questionnaire, yielding a response rate of 80 percent. Study Design A cross-sectional study design was used. Data were analyzed by correlation analyses and structural equation modeling. Principal Findings Performance obstacles were found to affect perceived quality and safety of care and QWL of ICU nurses. Workload mediated the impact of performance obstacles with the exception of equipment-related issues on perceived quality and safety of care as well as QWL. Conclusions Performance obstacles in ICUs are a major determinant of nursing workload, perceived quality and safety of care, and QWL. In general, performance obstacles increase nursing workload, which in turn negatively affect perceived quality and safety of care and QWL. Redesigning the ICU work system to reduce performance obstacles may improve nurses‘ work. PMID:19207589

Reliability and quality assurance on the MOD 2 wind system

NASA Technical Reports Server (NTRS)

Mason, W. E. B.; Jones, B. G.

1981-01-01

The Safety, Reliability, and Quality Assurance (R&QA) approach developed for the largest wind turbine generator, the Mod 2, is described. The R&QA approach assures that the machine is not hazardous to the public or to the operating personnel, is operated unattended on a utility grid, demonstrates reliable operation, and helps establish the quality assurance and maintainability requirements for future wind turbine projects. The significant guideline consisted of a failure modes and effects analysis (FMEA) during the design phase, hardware inspections during parts fabrication, and three simple documents to control activities during machine construction and operation.

Implementation of a "No Fly" safety culture in a multicenter radiation medicine department.

PubMed

Potters, Louis; Kapur, Ajay

2012-01-01

The safe delivery of radiation therapy requires multiple disciplines and interactions to perform flawlessly for each patient. Because treatment is individualized and every aspect of the patient's care is unique, it is difficult to regiment a delivery process that works flawlessly. The purpose of this study is to describe one safety-directed component of our quality program called the "No Fly Policy" (NFP). Our quality assurance program for radiation therapy reviewed the entire process of care prior, during, and after a patient's treatment course. Each component of care was broken down and rebuilt within a matrix of multidisciplinary safety quality checklists (QCL). The QCL process map was subsequently streamlined with revised task due dates and stopping rules. The NFP was introduced to place a holding pattern on treatment initiation pending reconciliation of associated stopping events. The NFP was introduced in a pilot phase using a Six-Sigma process improvement approach. Quantitative analysis on the performance of the new QCLs was performed using crystal reports in the Oncology Information Systems. Root cause analysis was conducted. Notable improvements in QCL performance were observed. The variances among staff in completing tasks reduced by a factor of at least 3, suggesting better process control. Steady improvements over time indicated an increasingly compliant and controlled adoption of the new safety-oriented process map. Stopping events led to rescheduling treatments with average and maximum delays of 2 and 4 days, respectively, with no reported adverse effects. The majority of stopping events were due to incomplete plan approvals stemming from treatment planning delays. Whereas these may have previously solicited last-minute interventions, including intensity modulated radiation therapy quality assurance, the NFP enabled nonpunitive, reasonable schedule adjustments to mitigate compromises in safe delivery. Implementation of the NFP has helped to mitigate risk from expedited care, convert reactive to proactive delays, and created a checklist, process driven, and variance-reducing culture in a large, multicenter department. Copyright © 2012 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

The effectiveness of an aged care specific leadership and management program on workforce, work environment, and care quality outcomes: design of a cluster randomised controlled trial

PubMed Central

2013-01-01

Background A plethora of observational evidence exists concerning the impact of management and leadership on workforce, work environment, and care quality. Yet, no randomised controlled trial has been conducted to test the effectiveness of leadership and management interventions in aged care. An innovative aged care clinical leadership program (Clinical Leadership in Aged Care − CLiAC) was developed to improve managers’ leadership capacities to support the delivery of quality care in Australia. This paper describes the study design of the cluster randomised controlled trial testing the effectiveness of the program. Methods Twenty-four residential and community aged care sites were recruited as managers at each site agreed in writing to participate in the study and ensure that leaders allocated to the control arm would not be offered the intervention program. Sites undergoing major managerial or structural changes were excluded. The 24 sites were randomly allocated to receive the CLiAC program (intervention) or usual care (control), stratified by type (residential vs. community, six each for each arm). Treatment allocation was masked to assessors and staff of all participating sites. The objective is to establish the effectiveness of the CLiAC program in improving work environment, workforce retention, as well as care safety and quality, when compared to usual care. The primary outcomes are measures of work environment, care quality and safety, and staff turnover rates. Secondary outcomes include manager leadership capacity, staff absenteeism, intention to leave, stress levels, and job satisfaction. Differences between intervention and control groups will be analysed by researchers blinded to treatment allocation using linear regression of individual results adjusted for stratification and clustering by site (primary analysis), and additionally for baseline values and potential confounders (secondary analysis). Outcomes measured at the site level will be compared by cluster-level analysis. The overall costs and benefits of the program will also be assessed. Discussion The outcomes of the trial have the potential to inform actions to enhance leadership and management capabilities of the aged care workforce, address pressing issues about workforce shortages, and increase the quality of aged care services. Trial registration Australian New Zealand Clinical Trials Registry (ACTRN12611001070921) PMID:24160714

Ion mobility spectrometry for food quality and safety.

PubMed

Vautz, W; Zimmermann, D; Hartmann, M; Baumbach, J I; Nolte, J; Jung, J

2006-11-01

Ion mobility spectrometry is known to be a fast and sensitive technique for the detection of trace substances, and it is increasingly in demand not only for protection against explosives and chemical warfare agents, but also for new applications in medical diagnosis or process control. Generally, a gas phase sample is ionized by help of ultraviolet light, ss-radiation or partial discharges. The ions move in a weak electrical field towards a detector. During their drift they collide with a drift gas flowing in the opposite direction and, therefore, are slowed down depending on their size, shape and charge. As a result, different ions reach the detector at different drift times, which are characteristic for the ions considered. The number of ions reaching the detector are a measure of the concentration of the analyte. The method enables the identification and quantification of analytes with high sensitivity (ng l(-1) range). The selectivity can even be increased - as necessary for the analyses of complex mixtures - using pre-separation techniques such as gas chromatography or multi-capillary columns. No pre-concentration of the sample is necessary. Those characteristics of the method are preserved even in air with up to a 100% relative humidity rate. The suitability of the method for application in the field of food quality and safety - including storage, process and quality control as well as the characterization of food stuffs - was investigated in recent years for a number of representative examples, which are summarized in the following, including new studies as well: (1) the detection of metabolites from bacteria for the identification and control of their growth; (2) process control in food production - beer fermentation being an example; (3) the detection of the metabolites of mould for process control during cheese production, for quality control of raw materials or for the control of storage conditions; (4) the quality control of packaging materials during the production of polymeric materials; and (5) the characterization of products - wine being an example. The challenges of such applications were operation in humid air, fast on-line analyses of complex mixtures, high sensitivity - detection limits have to be, for example, in the range of the odour limits - and, in some cases, the necessity of mobile instrumentation. It can be shown that ion mobility spectrometry is optimally capable of fulfilling those challenges for many applications.

Documenting quality improvement and patient safety efforts: the quality portfolio. A statement from the academic hospitalist taskforce.

PubMed

Taylor, Benjamin B; Parekh, Vikas; Estrada, Carlos A; Schleyer, Anneliese; Sharpe, Bradley

2014-01-01

Physicians increasingly investigate, work, and teach to improve the quality of care and safety of care delivery. The Society of General Internal Medicine Academic Hospitalist Task Force sought to develop a practical tool, the quality portfolio, to systematically document quality and safety achievements. The quality portfolio was vetted with internal and external stakeholders including national leaders in academic medicine. The portfolio was refined for implementation to include an outlined framework, detailed instructions for use and an example to guide users. The portfolio has eight categories including: (1) a faculty narrative, (2) leadership and administrative activities, (3) project activities, (4) education and curricula, (5) research and scholarship, (6) honors, awards, and recognition, (7) training and certification, and (8) an appendix. The authors offer this comprehensive, yet practical tool as a method to document quality and safety activities. It is relevant for physicians across disciplines and institutions and may be useful as a standalone document or as an adjunct to traditional promotion documents. As the Next Accreditation System is implemented, academic medical centers will require faculty who can teach and implement the systems-based practice requirements. The quality portfolio is a method to document quality improvement and safety activities.

Hypergol Systems: Design, Buildup, and Operation

NASA Technical Reports Server (NTRS)

Baker, David; Rathgeber, Kurt

2006-01-01

This course was developed by personnel at the NASA JSC White Sands Test Facility in conjunction with the NASA Safety Training Center (NSTC). The NSTC was established in May 1991 by the NASA Headquarters Safety Directorate to provide up-to-date, high-quality, NASA specific safety training on location at NASA centers, or simultaneously to multiple centers over the Video Teleconferencing System (ViTS). Our desire is to establish and maintain a strong, long-lasting relationship with all NASA centers in order to fulfill your safety training needs on a cost-effective basis. Our ultimate goal is to provide a positive contribution to safe operations at NASA. NSTC Course 055 is a 2-day course discussing the safe usage of hypergols (hydrazine fuels and nitrogen tetroxide). During the course we will identify the hazards associated with hypergols including toxicity, reactivity, fire, and explosion. Management of risk is discussed in terms of the primary engineering controls design, buildup, and operation; and secondary controls personal protective equipment and detectors/monitors. The emphasis is on the design and buildup of compatible systems and the safe operation of these systems by technicians and engineers.

The impact of information technology and organizational focus on the visibility of patient care errors.

PubMed

Walston, Stephen L; Mwachofi, Ari; Aldosari, Bakheet; Al-Omar, Badran A; Yousef, Asmaa Al; Sheikh, Asiya

2010-01-01

INVESTIGATED: The implementation of information systems and the creation of an open culture, characterized by emphasis on patient safety and problem solving, are 2 means suggested to improve health care quality. This study examines the effects of use of information technology and focus on patient safety and problem solving on the visibility of patient care errors. A survey of nurses in Saudi Arabia is analyzed by means of factor analysis and multiregression analysis to examine nurses' use of information technology and culture in controlling errors. Our research suggests that greater use of information technology to control patient care errors may reduce the prevalence of such errors while an increased focus on patient safety and problem solving facilitates an open environment where errors can be more openly discussed and addressed. The use of technology appears to have a role in decreasing errors. Yet, an organization that focuses on problem solving and patient safety can open lines of communication and create a culture in which errors can be discussed and resolved.

Huperzine A for treatment of cognitive impairment in major depressive disorder: a systematic review of randomized controlled trials.

PubMed

Zheng, Wei; Xiang, Ying-Qiang; Ungvari, Gabor S; Chiu, F K Helen; H Ng, Chee; Wang, Ying; Xiang, Yu-Tao

2016-04-25

Acetylcholinesterase (AChE) inhibitors have been shown to be effective in treating cognitive impairment in animal models and in human subjects with major depressive disorder (MDD). Huperzine A (HupA), a Traditional Chinese Medicine derived from a genus of clubmosses known as Huperzineserrata, is a powerful AChE inhibitor that has been used as an adjunctive treatment for MDD, but no meta-analysis on HupA augmentation for MDD has yet been reported. Conduct a systematic review and meta-analysis of randomized controlled trials (RCTS) about HupA augmentation in the treatment of MDD to evaluate its efficacy and safety. Two evaluators independently searched nine English-language and Chinese-language databases, selected relevant studies that met pre-determined inclusion criteria, extracted data about outcome and safety, and conducted quality assessments and data synthesis. Three low-quality RCTs (pooled n=238) from China were identified that compared monotherapy antidepressant treatment for depression versus combined treatment with antidepressants and HupA. Participants in the studies ranged from 16 to 60 years of age. The average duration of adjunctive antidepressant and HupA treatment in the studies was only 6.7 weeks. All three studies were open label and non-blinded, so their overall quality was judged as poor. Meta-analysis of the pooled sample found no significant difference in the improvement in depressive symptoms between the two groups (weighted mean difference: -1.90 (95%CI: -4.23, 0.44), p=0.11). However, the adjunctive HupA group did have significantly greater improvement than the antidepressant only group in cognitive functioning (as assessed by the Wisconsin Card Sorting Test and the Wechsler Memory Scale-Revised) and in quality of life. There was no significant difference in the incidence of adverse drug reactions between groups. The data available on the effectiveness and safety of adjunctive treatment using HupA in patients with MDD who are receiving antidepressants is insufficient to arrive at a definitive conclusion about its efficacy and safety. Pooling of the data from three low-quality RCTs from China found no advantage of adjunctive HupA in the treatment of depressive symptoms, but adjunctive treatment with HupA was associated with a faster resolution of the cognitive symptoms that frequently accompany MDD.

Huperzine A for treatment of cognitive impairment in major depressive disorder: a systematic review of randomized controlled trials

PubMed Central

ZHENG, Wei; XIANG, Ying-Qiang; UNGVARI, Gabor S.; CHIU, F.K. Helen; H. NG, Chee; WANG, Ying; XIANG, Yu-Tao

2016-01-01

Background Acetylcholinesterase (AChE) inhibitors have been shown to be effective in treating cognitive impairment in animal models and in human subjects with major depressive disorder (MDD). Huperzine A (HupA), a Traditional Chinese Medicine derived from a genus of clubmosses known as Huperzineserrata, is a powerful AChE inhibitor that has been used as an adjunctive treatment for MDD, but no meta-analysis on HupA augmentation for MDD has yet been reported. Aim Conduct a systematic review and meta-analysis of randomized controlled trials (RCTS) about HupA augmentation in the treatment of MDD to evaluate its efficacy and safety. Methods Two evaluators independently searched nine English-language and Chinese-language databases, selected relevant studies that met pre-determined inclusion criteria, extracted data about outcome and safety, and conducted quality assessments and data synthesis. Results Three low-quality RCTs (pooled n=238) from China were identified that compared monotherapy antidepressant treatment for depression versus combined treatment with antidepressants and HupA. Participants in the studies ranged from 16 to 60 years of age. The average duration of adjunctive antidepressant and HupA treatment in the studies was only 6.7 weeks. All three studies were open label and non-blinded, so their overall quality was judged as poor. Meta-analysis of the pooled sample found no significant difference in the improvement in depressive symptoms between the two groups (weighted mean difference: -1.90 (95%CI: -4.23, 0.44), p=0.11). However, the adjunctive HupA group did have significantly greater improvement than the antidepressant only group in cognitive functioning (as assessed by the Wisconsin Card Sorting Test and the Wechsler Memory Scale-Revised) and in quality of life. There was no significant difference in the incidence of adverse drug reactions between groups. Conclusions The data available on the effectiveness and safety of adjunctive treatment using HupA in patients with MDD who are receiving antidepressants is insufficient to arrive at a definitive conclusion about its efficacy and safety. Pooling of the data from three low-quality RCTs from China found no advantage of adjunctive HupA in the treatment of depressive symptoms, but adjunctive treatment with HupA was associated with a faster resolution of the cognitive symptoms that frequently accompany MDD. PMID:27605862

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

Malkoske, Kyle; Nielsen, Michelle; Brown, Erika

The Canadian Partnership for Quality Radiotherapy (CPQR) and the Canadian Organization of Medical Physicist’s (COMP) Quality Assurance and Radiation Safety Advisory Committee (QARSAC) have worked together in the development of a suite of Technical Quality Control (TQC) Guidelines for radiation treatment equipment and technologies, that outline specific performance objectives and criteria that equipment should meet in order to assure an acceptable level of radiation treatment quality. Early community engagement and uptake survey data showed 70% of Canadian centers are part of this process and that the data in the guideline documents reflect, and are influencing the way Canadian radiation treatmentmore » centres run their technical quality control programs. As the TQC development framework matured as a cross-country initiative, guidance documents have been developed in many clinical technologies. Recently, there have been new TQC documents initiated for Gamma Knife and Cyberknife technologies where the entire communities within Canada are involved in the review process. At the same time, QARSAC reviewed the suite as a whole for the first time and it was found that some tests and tolerances overlapped across multiple documents as single tests could pertain to multiple quality control areas. The work to streamline the entire suite has allowed for improved usability of the suite while keeping the integrity of single quality control areas. The suite will be published by the JACMP, in the coming year.« less

Effectiveness, safety, and effect on quality of life of topical salicylic acid peels for treatment of postinflammatory hyperpigmentation in dark skin.

PubMed

Joshi, Smita S; Boone, Susan L; Alam, Murad; Yoo, Simon; White, Lucile; Rademaker, Alfred; Helenowski, Irene; West, Dennis P; Kundu, Roopal V

2009-04-01

There are no randomized split-face model studies investigating treatments for postinflammatory hyperpigmentation (PIH) in dark skin. To assess the efficacy, safety, and effect on quality of life of salicylic acid peels for PIH in dark skin. Ten subjects with Fitzpatrick skin phototypes IV to VI were randomized to receive two 20% salicylic acid peels followed by three 30% salicylic acid peels to half of the face. The contralateral half remained untreated. Response was evaluated by photography reviewed by three blinded dermatologists. The Visual Analog Scale, Dermatology Life Quality Index (DLQI), and treatment quality questionnaire were administered. Improvement of PIH on the treatment side according to each rater (p=.81, p=.81, p=.42) and according to the raters combined (p=.11) approached but did not reach statistical significance. Subjects' Visual Analog Scale scores indicated significantly greater improvement of PIH on the treatment side than in the control (p=.004). Quality of life measured according to the DLQI improved after treatment but not statistically significantly so (p=.13). Treatment had no significant adverse effects. Salicylic acid peels are safe in this population. Although patients rated them as clinically effective, blinded raters found a brief series of peels to have less efficacy. Measured quality of life improved nominally.

[Significance of re-evaluation and development of Chinese herbal drugs].

PubMed

Gao, Yue; Ma, Zengchun; Zhang, Boli

2012-01-01

The research of new herbal drugs involves in new herbal drugs development and renew the old drugs. It is necessary to research new herbal drugs based on the theory of traditional Chinese medicine (TCM). The current development of famous TCM focuses on the manufacture process, quality control standards, material basis and clinical research. But system management of security evaluation is deficient, the relevant system for the safety assessment TCM has not been established. The causes of security problems, security risks, target organ of toxicity, weak link of safety evaluation, and ideas of safety evaluation are discussed in this paper. The toxicology research of chinese herbal drugs is necessary based on standard of good laboratory practices (GLP), the characteristic of Chinese herbal drugs is necessary to be fully integrated into safety evaluation. The safety of new drug research is necessary to be integrated throughout the entire process. Famous Chinese medicine safety research must be paid more attention in the future.

The FDA's Experience with Emerging Genomics Technologies-Past, Present, and Future.

PubMed

Xu, Joshua; Thakkar, Shraddha; Gong, Binsheng; Tong, Weida

2016-07-01

The rapid advancement of emerging genomics technologies and their application for assessing safety and efficacy of FDA-regulated products require a high standard of reliability and robustness supporting regulatory decision-making in the FDA. To facilitate the regulatory application, the FDA implemented a novel data submission program, Voluntary Genomics Data Submission (VGDS), and also to engage the stakeholders. As part of the endeavor, for the past 10 years, the FDA has led an international consortium of regulatory agencies, academia, pharmaceutical companies, and genomics platform providers, which was named MicroArray Quality Control Consortium (MAQC), to address issues such as reproducibility, precision, specificity/sensitivity, and data interpretation. Three projects have been completed so far assessing these genomics technologies: gene expression microarrays, whole genome genotyping arrays, and whole transcriptome sequencing (i.e., RNA-seq). The resultant studies provide the basic parameters for fit-for-purpose application of these new data streams in regulatory environments, and the solutions have been made available to the public through peer-reviewed publications. The latest MAQC project is also called the SEquencing Quality Control (SEQC) project focused on next-generation sequencing. Using reference samples with built-in controls, SEQC studies have demonstrated that relative gene expression can be measured accurately and reliably across laboratories and RNA-seq platforms. Besides prediction performance comparable to microarrays in clinical settings and safety assessments, RNA-seq is shown to have better sensitivity for low expression and reveal novel transcriptomic features. Future effort of MAQC will be focused on quality control of whole genome sequencing and targeted sequencing.

The FDA’s Experience with Emerging Genomics Technologies—Past, Present, and Future

PubMed Central

Xu, Joshua; Thakkar, Shraddha; Gong, Binsheng; Tong, Weida

2016-01-01

The rapid advancement of emerging genomics technologies and their application for assessing safety and efficacy of FDA-regulated products require a high standard of reliability and robustness supporting regulatory decision-making in the FDA. To facilitate the regulatory application, the FDA implemented a novel data submission program, Voluntary Genomics Data Submission (VGDS), and also to engage the stakeholders. As part of the endeavor, for the past 10 years, the FDA has led an international consortium of regulatory agencies, academia, pharmaceutical companies, and genomics platform providers, which was named MicroArray Quality Control Consortium (MAQC), to address issues such as reproducibility, precision, specificity/sensitivity, and data interpretation. Three projects have been completed so far assessing these genomics technologies: gene expression microarrays, whole genome genotyping arrays, and whole transcriptome sequencing (i.e., RNA-seq). The resultant studies provide the basic parameters for fit-for-purpose application of these new data streams in regulatory environments, and the solutions have been made available to the public through peer-reviewed publications. The latest MAQC project is also called the SEquencing Quality Control (SEQC) project focused on next-generation sequencing. Using reference samples with built-in controls, SEQC studies have demonstrated that relative gene expression can be measured accurately and reliably across laboratories and RNA-seq platforms. Besides prediction performance comparable to microarrays in clinical settings and safety assessments, RNA-seq is shown to have better sensitivity for low expression and reveal novel transcriptomic features. Future effort of MAQC will be focused on quality control of whole genome sequencing and targeted sequencing. PMID:27116022

Identification, assessment, and control of hazards in water supply: experiences from Water Safety Plan implementations in Germany.

PubMed

Mälzer, H-J; Staben, N; Hein, A; Merkel, W

2010-01-01

According to the recommendations of the World Health Organization (WHO) for Water Safety Plans (WSP), a Technical Risk Management was developed, which considers standard demands in drinking water treatment in Germany. It was already implemented at several drinking water treatment plants of different size and treatment processes in Germany. Hazards affecting water quality, continuity, and the reliability of supply from catchment to treatment and distribution could be identified by a systematic approach, and suitable control measures were defined. Experiences are presented by detailed examples covering methods, practical consequences, and further outcomes. The method and the benefits for the water suppliers are discussed and an outlook on the future role of WSPs in German water supply is given.

Statistical process control methods allow the analysis and improvement of anesthesia care.

PubMed

Fasting, Sigurd; Gisvold, Sven E

2003-10-01

Quality aspects of the anesthetic process are reflected in the rate of intraoperative adverse events. The purpose of this report is to illustrate how the quality of the anesthesia process can be analyzed using statistical process control methods, and exemplify how this analysis can be used for quality improvement. We prospectively recorded anesthesia-related data from all anesthetics for five years. The data included intraoperative adverse events, which were graded into four levels, according to severity. We selected four adverse events, representing important quality and safety aspects, for statistical process control analysis. These were: inadequate regional anesthesia, difficult emergence from general anesthesia, intubation difficulties and drug errors. We analyzed the underlying process using 'p-charts' for statistical process control. In 65,170 anesthetics we recorded adverse events in 18.3%; mostly of lesser severity. Control charts were used to define statistically the predictable normal variation in problem rate, and then used as a basis for analysis of the selected problems with the following results: Inadequate plexus anesthesia: stable process, but unacceptably high failure rate; Difficult emergence: unstable process, because of quality improvement efforts; Intubation difficulties: stable process, rate acceptable; Medication errors: methodology not suited because of low rate of errors. By applying statistical process control methods to the analysis of adverse events, we have exemplified how this allows us to determine if a process is stable, whether an intervention is required, and if quality improvement efforts have the desired effect.

Positioning Continuing Education: Boundaries and Intersections between the Domains Continuing Education, Knowledge Translation, Patient Safety and Quality Improvement

ERIC Educational Resources Information Center

Kitto, Simon; Bell, Mary; Peller, Jennifer; Sargeant, Joan; Etchells, Edward; Reeves, Scott; Silver, Ivan

2013-01-01

Public and professional concern about health care quality, safety and efficiency is growing. Continuing education, knowledge translation, patient safety and quality improvement have made concerted efforts to address these issues. However, a coordinated and integrated effort across these domains is lacking. This article explores and discusses the…

Safe teleoperation based on flexible intraoperative planning for robot-assisted laser microsurgery.

PubMed

Mattos, Leonardo S; Caldwell, Darwin G

2012-01-01

This paper describes a new intraoperative planning system created to improve precision and safety in teleoperated laser microsurgeries. It addresses major safety issues related to real-time control of a surgical laser during teleoperated procedures, which are related to the reliability and robustness of the telecommunication channels. Here, a safe solution is presented, consisting in a new planning system architecture that maintains the flexibility and benefits of real-time teleoperation and keeps the surgeon in control of all surgical actions. The developed system is based on our virtual scalpel system for robot-assisted laser microsurgery, and allows the intuitive use of stylus to create surgical plans directly over live video of the surgical field. In this case, surgical plans are defined as graphic objects overlaid on the live video, which can be easily modified or replaced as needed, and which are transmitted to the main surgical system controller for subsequent safe execution. In the process of improving safety, this new planning system also resulted in improved laser aiming precision and improved capability for higher quality laser procedures, both due to the new surgical plan execution module, which allows very fast and precise laser aiming control. Experimental results presented herein show that, in addition to the safety improvements, the new planning system resulted in a 48% improvement in laser aiming precision when compared to the previous virtual scalpel system.

[Quality of care and safety indicators in anticoagulated patients with non-valvular auricular fibrillation and deep venous thromboembolic disease].

PubMed

Ignacio, E; Mira, J J; Campos, F J; López de Sá, E; Lorenzo, A; Caballero, F

To identify and prioritise indicators to assess the quality of care and safety of patients with non-valvular auricular fibrillation (NVAF) and deep vein thrombosis (DVT) treated with anticoagulants. Using the consensus conference technique, a group of professionals and clinical experts, the determining factors of the NVAF and DVT care process were identified, in order to define the quality and safety criteria. A proposal was made for indicators of quality and safety that were prioritised, taking into account a series of pre-established attributes. The selected indicators were classified into indicators of context, safety, action, and outcomes of the intervention in the patient. A set of 114 health care and safety quality indicators were identified, of which 35 were prioritised: 15 for NVAF and 20 for DVT. About half (49%) of the indicators (40% for NVAF and 55% for DVT) applied to patient safety, and 26% (33% for NVAF and 20% for DVT) to the outcomes of interventions in the patient. The present work presents a set of agreed indicators by a group of expert professionals that can contribute to the improvement of the quality of care of patients with NVAF and DVT treated with anticoagulants. Copyright © 2018 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

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.

Psychological Treatment of Depression in People Aged 65 Years and Over: A Systematic Review of Efficacy, Safety, and Cost-Effectiveness

PubMed Central

Jonsson, Ulf; Bertilsson, Göran; Gyllensvärd, Harald; Söderlund, Anne; Tham, Anne; Andersson, Gerhard

2016-01-01

Objectives Depression in elderly people is a major public health concern. As response to antidepressants is often unsatisfactory in this age group, there is a need for evidence-based non-pharmacological treatment options. Our objectives were twofold: firstly, to synthesize published trials evaluating efficacy, safety and cost-effectiveness of psychological treatment of depression in the elderly and secondly, to assess the quality of evidence. Method The electronic databases PubMed, EMBASE, Cochrane Library, CINAL, Scopus, and PsycINFO were searched up to 23 May 2016 for randomized controlled trials (RCTs) of psychological treatment for depressive disorders or depressive symptoms in people aged 65 years and over. Two reviewers independently assessed relevant studies for risk of bias. Where appropriate, the results were synthesized in meta-analyses. The quality of the evidence was graded according to GRADE (Grading of Recommendations Assessment, Development and Evaluation). Results Twenty-two relevant RCTs were identified, eight of which were excluded from the synthesis due to a high risk of bias. Of the remaining trials, six evaluated problem-solving therapy (PST), five evaluated other forms of cognitive behavioural therapy (CBT), and three evaluated life review/reminiscence therapy. In frail elderly with depressive symptoms, the evidence supported the efficacy of PST, with large but heterogeneous effect sizes compared with treatment as usual. The results for life-review/reminiscence therapy and CBT were also promising, but because of the limited number of trials the quality of evidence was rated as very low. Safety data were not reported in any included trial. The only identified cost-effectiveness study estimated an incremental cost per additional point reduction in Beck Depression Inventory II score for CBT compared with talking control and treatment as usual. Conclusion Psychological treatment is a feasible option for frail elderly with depressive symptoms. However, important questions about efficacy, generalizability, safety and cost-effectiveness remain. PMID:27537217

Application of miniaturized near-infrared spectroscopy for quality control of extemporaneous orodispersible films.

PubMed

Foo, Wen Chin; Widjaja, Effendi; Khong, Yuet Mei; Gokhale, Rajeev; Chan, Sui Yung

2018-02-20

Extemporaneous oral preparations are routinely compounded in the pharmacy due to a lack of suitable formulations for special populations. Such small-scale pharmacy preparations also present an avenue for individualized pharmacotherapy. Orodispersible films (ODF) have increasingly been evaluated as a suitable dosage form for extemporaneous oral preparations. Nevertheless, as with all other extemporaneous preparations, safety and quality remain a concern. Although the United States Pharmacopeia (USP) recommends analytical testing of compounded preparations for quality assurance, pharmaceutical assays are typically not routinely performed for such non-sterile pharmacy preparations, due to the complexity and high cost of conventional assay methods such as high performance liquid chromatography (HPLC). Spectroscopic methods including Raman, infrared and near-infrared spectroscopy have been successfully applied as quality control tools in the industry. The state-of-art benchtop spectrometers used in those studies have the advantage of superior resolution and performance, but are not suitable for use in a small-scale pharmacy setting. In this study, we investigated the application of a miniaturized near infrared (NIR) spectrometer as a quality control tool for identification and quantification of drug content in extemporaneous ODFs. Miniaturized near infrared (NIR) spectroscopy is suitable for small-scale pharmacy applications in view of its small size, portability, simple user interface, rapid measurement and real-time prediction results. Nevertheless, the challenge with miniaturized NIR spectroscopy is its lower resolution compared to state-of-art benchtop equipment. We have successfully developed NIR spectroscopy calibration models for identification of ODFs containing five different drugs, and quantification of drug content in ODFs containing 2-10mg ondansetron (OND). The qualitative model for drug identification produced 100% prediction accuracy. The quantitative model to predict OND drug content in ODFs was divided into two calibrations for improved accuracy: Calibration I and II covered the 2-4mg and 4-10mg ranges respectively. Validation was performed for method accuracy, linearity and precision. In conclusion, this study demonstrates the feasibility of miniaturized NIR spectroscopy as a quality control tool for small-scale, pharmacy preparations. Due to its non-destructive nature, every dosage unit can be tested thus affording positive impact on patient safety. Copyright © 2017 Elsevier B.V. All rights reserved.

Quality control system preparation for photogrammetric and laser scanning missions of Spanish national plan of aerial orthophotogpaphy (PNOA). (Polish Title: Opracowanie systemu kontroli jakości realizacji nalotów fotogrametrycznych i skaningowych dla hiszpańskiego narodowego planu ortofotomapy lotniczej (PNOA))

NASA Astrophysics Data System (ADS)

Rzonca, A.

2013-12-01

The paper presents the state of the art of quality control of photogrammetric and laser scanning data captured by airborne sensors. The described subject is very important for photogrammetric and LiDAR project execution, because the data quality a prior decides about the final product quality. On the other hand, precise and effective quality control process allows to execute the missions without wide margin of safety, especially in case of the mountain areas projects. For introduction, the author presents theoretical background of the quality control, basing on his own experience, instructions and technical documentation. He describes several variants of organization solutions. Basically, there are two main approaches: quality control of the captured data and the control of discrepancies of the flight plan and its results of its execution. Both of them are able to use test of control and analysis of the data. The test is an automatic algorithm controlling the data and generating the control report. Analysis is a less complicated process, that is based on documentation, data and metadata manual check. The example of quality control system for large area project was presented. The project is being realized periodically for the territory of all Spain and named National Plan of Aerial Orthophotography (Plan Nacional de Ortofotografía Aérea, PNOA). The system of the internal control guarantees its results soon after the flight and informs the flight team of the company. It allows to correct all the errors shortly after the flight and it might stop transferring the data to another team or company, for further data processing. The described system of data quality control contains geometrical and radiometrical control of photogrammetric data and geometrical control of LiDAR data. According to all specified parameters, it checks all of them and generates the reports. They are very helpful in case of some errors or low quality data. The paper includes the author experience in the field of data quality control, presents the conclusions and suggestions of the organization and technical aspects, with a short definition of the necessary control software.

Design of agricultural product quality safety retrospective supervision system of Jiangsu province

NASA Astrophysics Data System (ADS)

Wang, Kun

2017-08-01

In store and supermarkets to consumers can trace back agricultural products through the electronic province card to query their origin, planting, processing, packaging, testing and other important information and found that the problems. Quality and safety issues can identify the responsibility of the problem. This paper designs a retroactive supervision system for the quality and safety of agricultural products in Jiangsu Province. Based on the analysis of agricultural production and business process, the goal of Jiangsu agricultural product quality safety traceability system construction is established, and the specific functional requirements and non-functioning requirements of the retroactive system are analyzed, and the target is specified for the specific construction of the retroactive system. The design of the quality and safety traceability system in Jiangsu province contains the design of the overall design, the trace code design and the system function module.

Understanding the role of sleep quality and sleep duration in commercial driving safety.

PubMed

Lemke, Michael K; Apostolopoulos, Yorghos; Hege, Adam; Sönmez, Sevil; Wideman, Laurie

2016-12-01

Long-haul truck drivers in the United States suffer disproportionately high injury rates. Sleep is a critical factor in these outcomes, contributing to fatigue and degrading multiple aspects of safety-relevant performance. Both sleep duration and sleep quality are often compromised among truck drivers; however, much of the efforts to combat fatigue focus on sleep duration rather than sleep quality. Thus, the current study has two objectives: (1) to determine the degree to which sleep impacts safety-relevant performance among long-haul truck drivers; and (2) to evaluate workday and non-workday sleep quality and duration as predictors of drivers' safety-relevant performance. A non-experimental, descriptive, cross-sectional design was employed to collect survey and biometric data from 260 long-haul truck drivers. The Trucker Sleep Disorders Survey was developed to assess sleep duration and quality, the impact of sleep on job performance and accident risk, and other relevant work organization characteristics. Descriptive statistics assessed work organization variables, sleep duration and quality, and frequency of engaging in safety-relevant performance while sleepy. Linear regression analyses were conducted to evaluate relationships between sleep duration, sleep quality, and work organization variables with safety composite variables. Drivers reported long work hours, with over 70% of drivers working more than 11h daily. Drivers also reported a large number of miles driven per week, with an average of 2,812.61 miles per week, and frequent violations of hours-of-service rules, with 43.8% of drivers "sometimes to always" violating the "14-h rule." Sleep duration was longer, and sleep quality was better, on non-workdays compared on workdays. Drivers frequently operated motor vehicles while sleepy, and sleepiness impacted several aspects of safety-relevant performance. Sleep quality was better associated with driving while sleepy and with job performance and concentration than sleep duration. Sleep duration was better associated with accidents and accident risk than sleep quality. Sleep quality appears to be better associated with safety-relevant performance among long-haul truck drivers than sleep duration. Comprehensive and multilevel efforts are needed to meaningfully address sleep quality among drivers. Copyright © 2016 Elsevier Ltd. All rights reserved.

Quality and productivity drive innovation and improvement at United Technologies Aerospace Operations, Inc.

NASA Technical Reports Server (NTRS)

Jamar, L. G.

1986-01-01

Quality and innovation are the hallmarks of the national space program. In programs that preceded the Shuttle Program the emphasis was on meeting the risks and technical challenges of space with safety, quality, reliability, and success. At United Technologies Aerospace Operations, Inc. (UTAO), the battle has developed along four primary fronts. These fronts include programs to motivate and reward people, development and construction of optimized processes and facilities, implementation of specifically tailored management systems, and the application of appropriate measurement and control systems. Each of these initiatives is described. However, to put this quality and productivity program in perspective, UTAO and its role in the Shuttle Program are described first.

Efficacy and safety of meditative movement therapies in fibromyalgia syndrome: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Langhorst, Jost; Klose, Petra; Dobos, Gustav J; Bernardy, Kathrin; Häuser, Winfried

2013-01-01

A systematic review with meta-analysis of the efficacy and safety of meditative movement therapies (Qigong, Tai Chi and Yoga) in fibromyalgia syndrome (FMS) was carried out. We screened Clinicaltrials.Gov, Cochrane Library, PsycINFO, PubMed and Scopus (through December 2010) and the reference sections of original studies for meditative movement therapies (MMT) in FMS. Randomized controlled trials (RCT) comparing MMT to controls were analysed. Outcomes of efficacy were pain, sleep, fatigue, depression and health-related quality of life (HRQOL). Effects were summarized using standardized mean differences (SMD [95% confidence interval]). Outcomes of safety were drop out because of adverse events and serious adverse events. A total of 7 out of 117 studies with 362 subjects and a median of 12 sessions (range 8-24) were included. MMT reduced sleep disturbances (-0.61 [-0.95, -0.27]; 0.0004), fatigue (-0.66 [-0.99, -0.34]; <0.0001), depression (-0.49 [-0.76, -0.22]; 0.0004) and limitations of HRQOL (-0.59 [-0.93, -0.24]; 0.0009), but not pain (-0.35 [-0.80, 0.11]; 0.14) compared to controls at final treatment. The significant effects on sleep disturbances (-0.52 [-0.97, -0.07]; 0.02) and HRQOL (-0.66 [-1.31, -0.01]; 0.05) could be maintained after a median of 4.5 (range 3-6) months. In subgroup analyses, only Yoga yielded significant effects on pain, fatigue, depression and HRQOL at final treatment. Drop out rate because of adverse events was 3.1%. No serious adverse events were reported. MMT are safe. Yoga had short-term beneficial effects on some key domains of FMS. There is a need for high-quality studies with larger sample sizes to confirm the results.

A Review on the Rising Prevalence of International Standards: Threats or Opportunities for the Agri-Food Produce Sector in Developing Countries, with a Focus on Examples from the MENA Region.

PubMed

Faour-Klingbeil, Dima; Todd, Ewen C D

2018-03-03

Food safety standards are a necessity to protect consumers' health in today's growing global food trade. A number of studies have suggested safety standards can interrupt trade, bringing financial and technical burdens on small as well as large agri-food producers in developing countries. Other examples have shown that economical extension, key intermediaries, and funded initiatives have substantially enhanced the capacities of growers in some countries of the Middle East and North Africa (MENA) region to meet the food safety and quality requirements, and improve their access to international markets. These endeavors often compensate for the weak regulatory framework, but do not offer a sustainable solution. There is a big gap in the food safety level and control systems between countries in the MENA region and those in the developed nations. This certainly has implications for the safety of fresh produce and agricultural practices, which hinders any progress in their international food trade. To overcome the barriers of legal and private standards, food safety should be a national priority for sustainable agricultural development in the MENA countries. Local governments have a primary role in adopting the vision for developing and facilitating the implementation of their national Good Agricultural Practices (GAP) standards that are consistent with the international requirements and adapted to local policies and environment. Together, the public and private sector's support are instrumental to deliver the skills and infrastructure needed for leveraging the safety and quality level of the agri-food chain.

A Review on the Rising Prevalence of International Standards: Threats or Opportunities for the Agri-Food Produce Sector in Developing Countries, with a Focus on Examples from the MENA Region

PubMed Central

Faour-Klingbeil, Dima

2018-01-01

Food safety standards are a necessity to protect consumers’ health in today’s growing global food trade. A number of studies have suggested safety standards can interrupt trade, bringing financial and technical burdens on small as well as large agri-food producers in developing countries. Other examples have shown that economical extension, key intermediaries, and funded initiatives have substantially enhanced the capacities of growers in some countries of the Middle East and North Africa (MENA) region to meet the food safety and quality requirements, and improve their access to international markets. These endeavors often compensate for the weak regulatory framework, but do not offer a sustainable solution. There is a big gap in the food safety level and control systems between countries in the MENA region and those in the developed nations. This certainly has implications for the safety of fresh produce and agricultural practices, which hinders any progress in their international food trade. To overcome the barriers of legal and private standards, food safety should be a national priority for sustainable agricultural development in the MENA countries. Local governments have a primary role in adopting the vision for developing and facilitating the implementation of their national Good Agricultural Practices (GAP) standards that are consistent with the international requirements and adapted to local policies and environment. Together, the public and private sector’s support are instrumental to deliver the skills and infrastructure needed for leveraging the safety and quality level of the agri-food chain. PMID:29510498

Unlicensed pharmaceutical preparations for clinical patient care: Ensuring safety.

PubMed

de Wilde, Sofieke; de Jong, Maria G H; Le Brun, Paul P H; Guchelaar, Henk-Jan; Schimmel, Kirsten J M

2018-01-01

Most medicinal products dispensed to patients have marketing authorization (MA) to ensure high quality of the product, safety, and efficacy. However, in daily practice, to treat patients adequately, there is a medical need for drugs that do not hold MA. To meet this medical need, medicinal products are used in clinical care without MA (unlicensed), such as products prepared by (local) pharmacies: the pharmaceutical preparations. Three types of pharmaceutical preparations are distinguished: (i) reconstitution in excess of summary of product characteristics; (ii) adaptation of a licensed medicinal product (outside its official labeling); (iii) medicinal products from an active pharmaceutical ingredient. Although unlicensed, patients may expect the same quality for these unlicensed pharmaceutical preparations as for the licensed medicinal products. To assure this quality, a proper risk-benefit assessment and proper documentation in (centralized) patient registries and linking to a national pharmacovigilance database should be in place. Based on a risk assessment matrix, requirements for quality assurance can be determined, which has impact on the level of documentation of a pharmaceutical preparation. In this paper, the approach for good documentation including quality assurance and benefit-risk assessment will be discussed and possibilities for patient registries are described to make these crucial preparations available for regular patient care. KEY POINTS Ensuring pharmaceutical quality and performing a proper benefit-risk assessment will guarantee safe use of pharmaceutical preparations. Good documentation of (ultra-)orphan treatments can be collected in centralized patient registries and should be combined with existing information in (inter)national databases and self-reflection of patients. Linking patient registries to a centralized database for adverse drug events is highly recommended as it increases safety control of the (ultra) orphan pharmaceutical preparations. Copyright © 2017 John Wiley & Sons, Ltd.

Software-safety and software quality assurance in real-time applications Part 2: Real-time structures and languages

NASA Astrophysics Data System (ADS)

Schoitsch, Erwin

1988-07-01

Our society is depending more and more on the reliability of embedded (real-time) computer systems even in every-day life. Considering the complexity of the real world, this might become a severe threat. Real-time programming is a discipline important not only in process control and data acquisition systems, but also in fields like communication, office automation, interactive databases, interactive graphics and operating systems development. General concepts of concurrent programming and constructs for process-synchronization are discussed in detail. Tasking and synchronization concepts, methods of process communication, interrupt- and timeout handling in systems based on semaphores, signals, conditional critical regions or on real-time languages like Concurrent PASCAL, MODULA, CHILL and ADA are explained and compared with each other and with respect to their potential to quality and safety.

Runoff delay exerts a strong control on the field-scale removal of manure-borne fecal bacteria with runoff

USDA-ARS?s Scientific Manuscript database

The microbial safety of surface waters is an ongoing issue which is threatened by the transport of manure-borne bacteria to water sources used for irrigation or recreation. Predictive modeling has become an effective tool to forecast the microbial quality of water duringprecipitation events, however...

Eddy Current, Magnetic Particle and Hardness Testing, Aviation Quality Control (Advanced): 9227.04.

ERIC Educational Resources Information Center

Dade County Public Schools, Miami, FL.

This unit of instruction includes the principles of eddy current, magnetic particle and hardness testing; standards used for analyzing test results; techniques of operating equipment; interpretation of indications; advantages and limitations of these methods of testing; care and calibration of equipment; and safety and work precautions. Motion…

49 CFR 236.1015 - PTC Safety Plan content requirements and PTC System Certification.

Code of Federal Regulations, 2010 CFR

2010-10-01

... established and can maintain a quality control system for PTC system design and manufacturing acceptable to... an explanation of the design principles and assumptions; (3) A risk assessment of the as-built PTC... the specific procedures and test equipment necessary to ensure the safe and proper installation...

Army position on lithium battery safety

NASA Technical Reports Server (NTRS)

Reiss, E.

1982-01-01

User requirements for lithium sulfur batteries are presented. They include careful analysis of design and quality control, along with certain equipment specifications. Some of the specifications include: hermetically sealed cells; lithium limited cells with stoichiometry of lithium to sulfur dioxide as a ratio of one; low moisture content in the cells; and battery capacity.

Strategies for field use of baculoviruses

Treesearch

J.D. Podgwaite

1985-01-01

In recent years, there has been increased awareness in maintaining the quality of the environment. This has led to the development and use of microbial agents as alternatives to chemicals for controlling noxious insect populations. The insect pathogens in the family Baculoviridae, by virtue of their specificity, virulence, and safety for nontarget species, have become...

Discrimination and identification of Q-markers based on 'Spider-web' mode for quality control of traditional Chinese medicine.

PubMed

Jiang, Zhenzuo; Yang, Jing; Wang, Yuefei

2017-12-28

The safety and effectiveness of traditional Chinese medicine (TCM) in clinical practice is directly related to the quality of TCM. And, the quality control of TCM is a pivotal issue to the quality of TCM, but also an obstacle impeding the modernization of TCM. The purpose of this work is to compile and develop a strategy based on discrimination and identification of quality markers (Q-markers) for quality control of TCM. Mainly established by seven variables derived from four dimensions including content, stability, pharmacokinetics and pharmacology, the 'Spider-web' mode was undertaken to assess the Q-marker property of candidate compounds originated from TCM by taking regression area (A) and coefficient variation (CV) of the tested compounds into account. The importance index (ImI), ImI = A × 1/CV, was suggested to focus Q-markers. The compounds with larger regression area (A) and less coefficient variation (CV) are preferentially adopted as Q-markers, which should possess the satisfactory properties of content, stability, pharmacokinetics and pharmacological activity. To the contrary, the compounds are excluded on the grounds of the unsatisfactory Q-markers' property, less regression area (A) and larger coefficient variation (CV), which cannot represent the quality of TCM. The 'Spider-web' mode can filter out the redundant constituents and focus on the key indexes of quality control - Q-markers. The screened Q-markers possess the optimal integrated properties of content, stability, pharmacokinetics and pharmacology among the numerous and complicated ingredients of TCM, which can comprehensively characterize inherent quality of TCM. In summary, the novel strategy established in this work provides a valuable perspective for the quality control of TCM. Copyright © 2017 Elsevier GmbH. All rights reserved.

Good manufacturing practice and viral safety.

PubMed

Kerner, B

1995-07-01

The concept of virus inactivation during the manufacture of blood products raises questions about possible recontamination of the product by the environment. A strict regime of good manufacturing practice (GMP) is mandatory. The guidelines originally issued by the World Health Organization (WHO), and now law in most countries, are an excellent basis for the operation of a production plant. The following elements of GMP require special concern: (i) All functions shall be defined in a clear organization chart. (ii) Personnel shall be appropriately trained for the job and to perfect hygiene. (iii) Buildings and facilities, as well as supply systems, shall exclude the possibility of recontamination of already virus-inactivated materials. (iv) Equipment shall be easy to clean and fully sterilizable. (v) Production shall follow appropriate written procedures. (vi) The Quality Control Organization shall monitor the process by in-process controls and review the records for possible deviations. All GMP issues are coordinated by a Quality Assurance Organization that also reviews the overall performance of the operation. The maintenance of viral safety of the products basically depends upon the full commitment of all bodies involved to proper and non-negotiable GMP.

Ozone in the food industry: Principles of ozone treatment, mechanisms of action, and applications: An overview.

PubMed

Brodowska, Agnieszka Joanna; Nowak, Agnieszka; Śmigielski, Krzysztof

2017-04-10

The food contamination issue requires continuous control of food at each step of the production process. High quality and safety of products are equally important factors in the food industry. They may be achieved with several, more or less technologically advanced methodologies. In this work, we review the role, contribution, importance, and impact of ozone as a decontaminating agent used to control and eliminate the presence of microorganisms in food products as well as to extend their shelf-life and remove undesirable odors. Several researchers have been focusing on the ozone's properties and applications, proving that ozone treatment technology can be applied to all types of foods, from fruits, vegetables, spices, meat, and seafood products to beverages. A compilation of those works, presented in this review, can be a useful tool for establishing appropriate ozone treatment conditions, and factors affecting the improved quality and safety of food products. A critical evaluation of the advantages and disadvantages of ozone in the context of its application in the food industry is presented as well.

The effectiveness and safety of acupuncture for poor semen quality in infertile males: a systematic review and meta-analysis

PubMed Central

Jerng, Ui Min; Jo, Jun-Young; Lee, Seunghoon; Lee, Jin-Moo; Kwon, Ohmin

2014-01-01

The aim of this review is to evaluate the effectiveness and safety of acupuncture for poor semen quality in infertile men. We searched for relevant trials registered up to May 2013 in 14 databases. We selected randomized controlled trials (RCTs) that compared acupuncture, with or without additional treatment, against placebo, sham, no treatment, or the same additional treatment. Two reviewers independently performed the study selection, data extraction, risk of bias and reporting quality appraisal. Risk of bias and reporting quality were appraised by the Cochrane risk of bias tool, the consolidated standards of reporting trials and Standards for Reporting Interventions in Clinical Trials of Acupuncture. The outcomes were sperm motility, sperm concentration, pregnancy rate, and adverse events. Pregnancy was defined as a positive pregnancy test. Four RCTs met the eligibility criteria. Acupuncture increased the percentage of sperm with rapid progression (mean difference - 6.35, 95% confidence interval (CI): 4.38–8.32, P< 0.00001) and sperm concentration (mean difference - 6.42, 95% CI: 4.91–7.92, P< 0.00001), but these two outcomes were substantially heterogeneous among the studies (I2 = 72% and 58%, respectively). No differences in pregnancy rate were found between acupuncture and control groups (odds ratio 1.60, 95% CI: 0.70–3.69, P= 0.27, I2 = 0%). No participants experienced adverse events. The current evidence showing that acupuncture might improve poor semen quality is insufficient because of the small number of studies, inadequacy of procedures and/or insufficient information for semen analysis, high levels of heterogeneity, high risk of bias, and poor quality of reporting. Further large, well-designed RCTs are required. PMID:25038176

Implementation of quality systems by Mexican exporters of processed meat.

PubMed

Maldonado-Siman, E; Bernal-Alcántara, R; Cadena-Meneses, J A; Altamirano-Cárdenas, J R; Martinez-Hernández, P A

2014-12-01

Requirements of hazard analysis and critical control points (HACCP) are becoming essential for international trade in food commodities as a safety assurance component. This research reports the level of the adoption of ISO 9000 and the HACCP system by Federal Inspection Type (TIF) pork-exporting enterprises. Implementation and operating costs are reported as well as the benefits involved in this food industry process. In Mexico, there are 97 companies classified as TIF enterprises, and 22 are registered as exporters of processed pork with the National Services for Safety and Quality and Animal Health of the Secretariat of Agriculture, Livestock, Rural Development, Fisheries and Food. Surveys were administered to 22 companies, with a 95.2% response rate. Enterprise characteristics were evaluated, as well as their operating activities. Fieldwork consisted of administering structured questionnaires to TIF exporters. All the surveyed enterprises had implemented HACCP, whereas the ISO 9000 regulation was applied in only 30%. Of total production, 75% is exported to 13 countries, and 25% goes to the Mexican market niche. Results indicate that the main factors for adopting HACCP are related to accessibility to international markets, improving quality, and reducing product quality audits by customers. The results also indicated that staff training was the most important issue. Microbiological testing was the highest cost of the operation. The main benefits reported were related to better access to international markets and a considerable reduction in microbial counts. This study shows the willingness of Mexican pork processors to implement food safety protocols for producing safe and quality products to compete in the international food trade.

Model-Based Safety Analysis

NASA Technical Reports Server (NTRS)

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

2006-01-01

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

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

PubMed Central

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

2015-01-01

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

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

PubMed

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

2015-05-01

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

The relationship between safety net activities and hospital financial performance

PubMed Central

2010-01-01

Background During the 1990's hospitals in the U.S were faced with cost containment charges, which may have disproportionately impacted hospitals that serve poor patients. The purposes of this paper are to study the impact of safety net activities on total profit margins and operating expenditures, and to trace these relationships over the 1990s for all U.S urban hospitals, controlling for hospital and market characteristics. Methods The primary data source used for this analysis is the Annual Survey of Hospitals from the American Hospital Association and Medicare Hospital Cost Reports for years 1990-1999. Ordinary least square, hospital fixed effects, and two-stage least square analyses were performed for years 1990-1999. Logged total profit margin and operating expenditure were the dependent variables. The safety net activities are the socioeconomic status of the population in the hospital serving area, and Medicaid intensity. In some specifications, we also included uncompensated care burden. Results We found little evidence of negative effects of safety net activities on total margin. However, hospitals serving a low socioeconomic population had lower expenditure raising concerns for the quality of the services provided. Conclusions Despite potentially negative policy and market changes during the 1990s, safety net activities do not appear to have imperiled the survival of hospitals. There may, however, be concerns about the long-term quality of the services for hospitals serving low socioeconomic population. PMID:20074367

The Effectiveness and Safety of Manual Therapy on Pain and Disability in Older Persons With Chronic Low Back Pain: A Systematic Review.

PubMed

de Luca, Katie E; Fang, Sheng Hung; Ong, Justin; Shin, Ki-Soo; Woods, Samuel; Tuchin, Peter J

2017-09-01

The aim of this study was to perform a systematic review of the literature of the effectiveness and safety of manual therapy interventions on pain and disability in older persons with chronic low back pain (LBP). A literature search of 4 electronic databases was performed (PubMed, EMBASE, OVID, and CINAHL). Inclusion criteria included randomized controlled trials of manual therapy interventions on older persons who had chronic LBP. Effectiveness was determined by extracting and examining outcomes for pain and disability, with safety determined by the report of adverse events. The PEDro scale was used for quality assessment of eligible studies. The search identified 405 articles, and 38 full-text articles were assessed. Four studies met the inclusion criteria. All trials were of good methodologic quality and had a low risk of bias. The included studies provided moderate evidence supporting the use of manual therapy to reduce pain levels and alleviate disability. A limited number of studies have investigated the effectiveness and safety of manual therapy in the management of older people with chronic LBP. The current evidence to make firm clinical recommendations is limited. Research with appropriately designed trials to investigate the effectiveness and safety of manual therapy interventions in older persons with chronic LBP is required. Copyright © 2017. Published by Elsevier Inc.

Current Assessments of Quality and Safety Competencies in Registered Professional Nurses: An Examination of Nurse Leader Perceptions

ERIC Educational Resources Information Center

Smith, Elaine Lois

2012-01-01

Quality and safety in healthcare is a national concern. It has been proposed that nurses and other clinicians need to develop a new set of competencies in order to make significant improvements in the quality and safety of patient care. These new competencies include: patient-centered care; teamwork and collaboration; evidence-based practice;…

A Comparison of Urban and Rural Kindergarten Teachers' Perceptions of School Safety for Young Children: Implications for Quality Teacher Education

ERIC Educational Resources Information Center

Wong, Yau-ho Paul

2017-01-01

Although a quality preschool supports young children's health and safety, "quality" has been defined diversely enough that its delivery has been varied among kindergarten teachers. The current study was the first to examine and compare perceptions of school safety between urban and rural kindergarten teachers. Sixty-seven Hong Kong…

Towards a sociology of healthcare safety and quality.

PubMed

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

2016-02-01

The contributions to this collection address technologies, practices, experiences and the organisation of quality and safety across a wide range of healthcare contexts. Spanning three continents, from hospital to community, maternity to mental health, they shine a light into the boardrooms, back offices and front-lines of healthcare, offering sociological insights from the perspectives of managers, clinicians and patients. We review these articles and consider how they contribute to some of the dilemmas that confront mainstream approaches to quality and safety and then look ahead to outline future lines of sociological inquiry to progress the theory and practice of quality and safety. © 2015 Foundation for the Sociology of Health & Illness.

Nursing work environment, patient safety and quality of care in pediatric hospital.

PubMed

Alves, Daniela Fernanda Dos Santos; Guirardello, Edinêis de Brito

2016-06-01

Objectives To describe the characteristics of the nursing work environment, safety attitudes, quality of care, measured by the nursing staff of the pediatric units, as well as to analyze the evolution of quality of care and hospital indicators. Methods Descriptive study with 136 nursing professionals at a paediatric hospital, conducted through personal and professional characterization form, Nursing Work Index - Revised, Safety Attitudes Questionnaire - Short Form 2006 and quality indicators. Results The professionals perceive the environment as favourable to professional practice, and consider good quality care that is also observed by reducing the incidence of adverse events and decreased length of stay. The domain job satisfaction was considered favourable to patient safety. Conclusions The work environment is favourable to nursing practice, the professionals nursing approve the quality of care and the indicators tended reducing adverse events and length of stay.

Changing conversations: teaching safety and quality in residency training.

PubMed

Voss, John D; May, Natalie B; Schorling, John B; Lyman, Jason A; Schectman, Joel M; Wolf, Andrew M D; Nadkarni, Mohan M; Plews-Ogan, Margaret

2008-11-01

Improving patient safety and quality in health care is one of medicine's most pressing challenges. Residency training programs have a unique opportunity to meet this challenge by training physicians in the science and methods of patient safety and quality improvement (QI).With support from the Health Resources and Services Administration, the authors developed an innovative, longitudinal, experiential curriculum in patient safety and QI for internal medicine residents at the University of Virginia. This two-year curriculum teaches the critical concepts and skills of patient safety and QI: systems thinking and human factors analysis, root cause analysis (RCA), and process mapping. Residents apply these skills in a series of QI and patient safety projects. The constructivist educational model creates a learning environment that actively engages residents in improving the quality and safety of their medical practice.Between 2003 and 2005, 38 residents completed RCAs of adverse events. The RCAs identified causes and proposed useful interventions that have produced important care improvements. Qualitative analysis demonstrates that the curriculum shifted residents' thinking about patient safety to a systems-based approach. Residents completed 237 outcome assessments during three years. Results indicate that seminars met predefined learning objectives and were interactive and enjoyable. Residents strongly believe they gained important skills in all domains.The challenge to improve quality and safety in health care requires physicians to learn new knowledge and skills. Graduate medical education can equip new physicians with the skills necessary to lead the movement to safer and better quality of care for all patients.This article is part of a theme issue of Academic Medicine on the Title VII health professions training programs.

42 CFR 416.43 - Conditions for coverage-Quality assessment and performance improvement.

Code of Federal Regulations, 2013 CFR

2013-10-01

... outcomes, patient safety, and quality of care. (2) Performance improvement activities must track adverse... improves patient safety by using quality indicators or performance measures associated with improved health... incorporate quality indicator data, including patient care and other relevant data regarding services...

42 CFR 416.43 - Conditions for coverage-Quality assessment and performance improvement.

Code of Federal Regulations, 2012 CFR

2012-10-01

... outcomes, patient safety, and quality of care. (2) Performance improvement activities must track adverse... improves patient safety by using quality indicators or performance measures associated with improved health... incorporate quality indicator data, including patient care and other relevant data regarding services...

42 CFR 416.43 - Conditions for coverage-Quality assessment and performance improvement.

Code of Federal Regulations, 2014 CFR

2014-10-01

... outcomes, patient safety, and quality of care. (2) Performance improvement activities must track adverse... improves patient safety by using quality indicators or performance measures associated with improved health... incorporate quality indicator data, including patient care and other relevant data regarding services...

Mindfulness for palliative care patients. Systematic review.

PubMed

Latorraca, Carolina de Oliveira Cruz; Martimbianco, Ana Luiza Cabrera; Pachito, Daniela Vianna; Pacheco, Rafael Leite; Riera, Rachel

2017-12-01

Nineteen million adults worldwide are in need of palliative care. Of those who have access to it, 80% fail to receive an efficient management of symptoms. To assess the effectiveness and safety of mindfulness meditation for palliative care patients. We searched CENTRAL, MEDLINE, Embase, LILACS, PEDro, CINAHL, PsycINFO, Opengrey, ClinicalTrials.gov and WHO-ICTRP. No restriction of language, status or date of publication was applied. We considered randomised clinical trials (RCTs) comparing any mindfulness meditation scheme vs any comparator for palliative care. Cochrane Risk of Bias (Rob) Table was used for assessing methodological quality of RCTs. Screening, data extraction and methodological assessments were performed by two reviewers. Mean differences (MD) (confidence intervals of 95% (CI 95%)) were considered for estimating effect size. Quality of evidence was appraised by GRADE. Four RCTs, 234 participants, were included. All studies presented high risk of bias in at least one RoB table criteria. We assessed 4 comparisons, but only 2 studies showed statistically significant difference for at least one outcome. 1. Mindfulness meditation (eight weeks, one session/week, daily individual practice) vs control: statistically significant difference in favour of control for quality of life - physical aspects. 2. Mindfulness meditation (single 5-minute session) vs control: benefit in favour of mindfulness for stress outcome in both time-points. None of the included studies analysed safety and harms outcomes. Although two studies have showed statistically significant difference, only one showed effectiveness of mindfulness meditation in improving perceived stress. This study focused on one single session of mindfulness of 5 minutes for adult cancer patients in palliative care, but it was considered as possessing high risk of bias. Other schemes of mindfulness meditation did not show benefit in any outcome evaluated (low and very low quality evidence). © 2017 John Wiley & Sons Ltd.

[Efficacy and safety of Danhong injection for idiopathic pulmonary fibrosis：Meta-analysis].

PubMed

Xin, Li-Li; Jiang, Miao; Zhang, Geng; Gong, Jie-Ning

2016-10-01

To systematically review the efficacy and safety of Danhong injection for patients with idiopathic pulmonary fibrosis(IPF), two researchers electronically searched PubMed, EMbase, Web of Science, Cochrane Library, CNKI, CBM, WanFang Data and VIP databases from the date of establishment to May 2016 for all randomized controlled trials(RCTs) and quasi-RCTs on the use of Danhong injection in patients with IPF. Manual search in relevant journals and search of relevant literature on other websites were also performed. The data extraction and quality assessment of included RCTs and quasi-RCT were conducted by two reviewers independently. Then, Meta-analysis was conducted by using RevMan 5.3 software. A total of 12 RCTs involving 844 patients were included, 423 cases in experiment group and 421 cases in control group. The results of meta-analysis indicated that the Danhong injection group was superior than the control group in clinical effectiveness(RR=1.36, 95%CI 1.25 to 1.49, P<0.000 01), increased DLCO value(MD=4.25, 95%CI 3.32 to 5.18, P<0.000 01), and increased PaO2 value(MD=14.51, 95%CI 12.35 to 16.68, P<0.000 01). The analysis results showed that Danhong injection could significantly reduce the level of TGF-β1 in serum. There were no serious or frequently happened adverse effects in the Danhong injection group, indicating high safety and good tolerance of Danhong injection in treatment of IPF. The current evidences suggested that Danhong injection in short term use(<12 weeks) could increase clinical effectiveness, improve DLCO and PaO2, and decrease the level of TGF-β1 in serum of IPF patients, with less adverse effects. However, these results should be carefully interpreted due to the low methodology quality and small sample size of trials, and this conclusion had to be further verified by high quality, large scale and double blinded RCTs. Copyright© by the Chinese Pharmaceutical Association.

Residual risk of bacterial contamination of platelets: six years of experience with sterility testing.

PubMed

Ramirez-Arcos, Sandra; DiFranco, Caesar; McIntyre, Terri; Goldman, Mindy

2017-09-01

Canadian Blood Services screens 100% of platelet concentrates (PCs) for bacterial contamination with the BacT/ALERT system. Quality-control sterility testing of 1% (≥10 units) of outdated PCs is performed monthly. Data from routine screening, quality-control testing, and septic reactions obtained from 2010 to 2016 are presented herein. In total, 601,988 buffy coat PC pools and 186,737 apheresis PCs were routinely screened with aerobic cultures over 6 years. Outdate quality-control testing of 8535 buffy coat and 8498 apheresis PCs was performed using aerobic and anaerobic cultures during the same period. Results were classified as "true-positives" when the same bacterium was isolated in initial and confirmatory cultures or "false-negatives" when bacteria were missed in early screening and were captured during quality-control sterility testing or through investigation of sepsis cases. During routine screening, the true-positive rates between buffy coat (0.94 per 10,000) and apheresis (0.96 per 10,000) PCs were similar (p = 0.9473). Seventy-five bacteria isolated during PC screening included Gram-positive and Gram-negative organisms. Six false-negative septic reactions were reported that implicated coagulase-negative staphylococci (n = 3) and Staphylococcus aureus (n = 3) for approximate rates of 1 per 100,000 transfusion reactions and 1 per 500,000 fatalities. During quality-control testing, the false-negative rates between buffy coat (8 per 10,000) and apheresis (9 per 10,000) PCs were similar (p = 0.7897). All 15 quality-control isolates were Gram-positive bacteria. The current bacterial screening protocol is efficacious for identifying Gram-negative bacteria. However, the high proportion of Gram-positive organisms detected on outdate quality-control testing and septic transfusion events demonstrates a residual safety risk that merits further intervention. © 2017 AABB.

Quality of Life for Diverse Older Adults in Assisted Living: The Centrality of Control.

PubMed

Koehn, Sharon D; Mahmood, Atiya N; Stott-Eveneshen, Sarah

This pilot project asked: How do ethnically diverse older adult residents of assisted living (AL) facilities in British Columbia (BC) experience quality of life? And, what role, if any, do organizational and physical environmental features play in influencing how quality of life is experienced? The study was conducted at three AL sites in BC: two ethnoculturally targeted and one nontargeted. Environmental audits at each site captured descriptive data on policies, fees, rules, staffing, meals, and activities, and the built environment of the AL building and neighborhood. Using a framework that understands the quality of life of older adults to be contingent on their capability to pursue 5 conceptual attributes-attachment, role, enjoyment, security, and control-we conducted 3 focus groups with residents (1 per site) and 6 interviews with staff (2 per site). Attributes were linked to the environmental features captured in the audits. All dimensions of the environment, especially organizational, influence tenants' capability to attain the attributes of quality of life, most importantly control. Although many tenants accept the trade-off between increased safety and diminished control that accompanies a move into AL, more could be done to minimize that loss. Social workers can advocate for the necessary multi-sectoral changes.

Learning from death: a hospital mortality reduction programme.

PubMed

Wright, John; Dugdale, Bob; Hammond, Ian; Jarman, Brian; Neary, Maria; Newton, Duncan; Patterson, Chris; Russon, Lynne; Stanley, Philip; Stephens, Rose; Warren, Erica

2006-06-01

There are wide variations in hospital mortality. Much of this variation remains unexplained and may reflect quality of care. A large acute hospital in an urban district in the North of England. Before and after evaluation of a hospital mortality reduction programme. Audit of hospital deaths to inform an evidence-based approach to identify processes of care to target for the hospital strategy. Establishment of a hospital mortality reduction group with senior leadership and support to ensure the alignment of the hospital departments to achieve a common goal. Robust measurement and regular feedback of hospital deaths using statistical process control charts and summaries of death certificates and routine hospital data. Whole system working across a health community to provide appropriate end of life care. Training and awareness in processes of high quality care such as clinical observation, medication safety and infection control. Hospital standardized mortality ratios fell significantly in the 3 years following the start of the programme from 94.6 (95% confidence interval 89.4, 99.9) in 2001 to 77.5 (95% CI 73.1, 82.1) in 2005. This translates as 905 fewer hospital deaths than expected during the period 2002-2005. Improving the safety of hospital care and reducing hospital deaths provides a clear and well supported goal from clinicians, managers and patients. Good leadership, good information, a quality improvement strategy based on good local evidence and a community-wide approach may be effective in improving the quality of processes of care sufficiently to reduce hospital mortality.

"A manager in the minds of doctors:" a comparison of new modes of control in European hospitals.

PubMed

Kuhlmann, Ellen; Burau, Viola; Correia, Tiago; Lewandowski, Roman; Lionis, Christos; Noordegraaf, Mirko; Repullo, Jose

2013-07-02

Hospital governance increasingly combines management and professional self-governance. This article maps the new emergent modes of control in a comparative perspective and aims to better understand the relationship between medicine and management as hybrid and context-dependent. Theoretically, we critically review approaches into the managerialism-professionalism relationship; methodologically, we expand cross-country comparison towards the meso-level of organisations; and empirically, the focus is on processes and actors in a range of European hospitals. The research is explorative and was carried out as part of the FP7 COST action IS0903 Medicine and Management, Working Group 2. Comprising seven European countries, the focus is on doctors and public hospitals. We use a comparative case study design that primarily draws on expert information and document analysis as well as other secondary sources. The findings reveal that managerial control is not simply an external force but increasingly integrated in medical professionalism. These processes of change are relevant in all countries but shaped by organisational settings, and therefore create different patterns of control: (1) 'integrated' control with high levels of coordination and coherent patterns for cost and quality controls; (2) 'partly integrated' control with diversity of coordination on hospital and department level and between cost and quality controls; and (3) 'fragmented' control with limited coordination and gaps between quality control more strongly dominated by medicine, and cost control by management. Our comparison highlights how organisations matter and brings the crucial relevance of 'coordination' of medicine and management across the levels (hospital/department) and the substance (cost/quality-safety) of control into perspective. Consequently, coordination may serve as a taxonomy of emergent modes of control, thus bringing new directions for cost-efficient and quality-effective hospital governance into perspective.

Work environment and health promotion needs among personnel in the faculty of medicine, Thammasat university.

PubMed

Buranatrevedh, Surasak

2013-04-01

Work environment and health promotion needs are important factors for quality of life of workers. Study occupational health and safety hazards and control measures as well as health status and health promotion needs among personnel in Faculty of Medicine, Thammasat University. This was a cross sectional study. Questionnaires were designed to collect demographic data, health status, health promotion needs, occupational health and safety hazards, and job demand/control data. Questionnaires were sent out to 181 personnel and 145 were returned filled-out (80.1%). Among them, 42.8% had physical illness or stress, 68.3% had debt problem, 20% had some problems with coworker or work environment, 65.5% had a high workload, and 64.1% felt they did not get enough work benefits. Job demand and control factors included attention from leaders, fast-pace work, relationship among coworkers, repetitive work, hard work, high stress work, and high workload The occupational safety and health system included training to use new equipment, supervisor training, work skill training, work in sitting position for long period of time, appropriate periodic health exam, appropriate medical service, proper canteen, proper salary raise, and facilities for health promotion. In the occupational health hazards, employees were working in low temperature, bright light, and had a lack of health promotion programs. Requested programs to improve quality of life were Thai traditional massage, workplace improvement, health promotion, one-day travel, and Friday's happy and healthy program. Results from the present study can be used to improve workplace environment and health of personnel in the Faculty of Medicine, Thammasat University.

[Does ultraclean air in the operating room provide greater safety?].

PubMed

van Tiel, Frank H; Buiting, Anton G; Meessen, Nico E L; Voss, Andreas; Vos, Margreet C

2010-01-01

The Dutch quality control plan for climatisation of the operating room (OR), which was published in 2005, describes the management and maintenance of the air conditioning system. This management plan proposes a standard for air quality in class 1 ORs. This has been adopted by the Dutch Orthopaedic Society, but not by other surgical societies. The British study which underlies the proposed norm for air quality in class 1 ORs, a study on the infection preventive effect of ultraclean air, dates from 1982 and is inadequately controlled for prophylactic use of antibiotics. Antibiotic prophylaxis in itself already reduces the number of surgical site infections.-More recent studies fail to show an infection preventive effect of ultraclean air in the OR. The Dutch Working Party for Infection Prevention (WIP) ought to take the initiative, together with the medical Scientific Societies and the Society of Infection Prevention and Control in the health care setting (VHIG), to establish enforceable norms for microbiological air quality and to set criteria as to which types of operations are allowed to be performed in which class of OR.

Chemical analysis of Panax quinquefolius (North American ginseng): A review.

PubMed

Wang, Yaping; Choi, Hyung-Kyoon; Brinckmann, Josef A; Jiang, Xue; Huang, Linfang

2015-12-24

Panax quinquefolius (PQ) is one of the best-selling natural health products due to its proposed beneficial anti-aging, anti-cancer, anti-stress, anti-fatigue, and anxiolytic effects. In recent years, the quality of PQ has received considerable attention. Sensitive and accurate methods for qualitative and quantitative analyses of chemical constituents are necessary for the comprehensive quality control to ensure the safety and efficacy of PQ. This article reviews recent progress in the chemical analysis of PQ and its preparations. Numerous analytical techniques, including spectroscopy, thin-layer chromatography (TLC), gas chromatography (GC), high-performance liquid chromatography (HPLC), liquid chromatography/mass spectrometry (LC/MS), high-speed centrifugal partition chromatography (HSCPC), high-performance counter-current chromatography (HPCCC), nuclear magnetic resonance spectroscopy (NMR), and immunoassay, are described. Among these techniques, HPLC coupled with mass spectrometry (MS) is the most promising method for quality control. The challenges encountered in the chemical analysis of PQ are also briefly discussed, and the remaining questions regarding the quality control of PQ that require further investigation are highlighted. Copyright © 2015 Elsevier B.V. All rights reserved.

Improving patient safety and healthcare quality: examples of good practice.

PubMed

Tingle, John

2017-07-27

John Tingle, Reader in Health Law at Nottingham Trent University, discusses a recent report by the Care Quality Commission that showcases eight NHS trusts that have improved their patient safety and healthcare quality.

FY 1991 safety program status report

NASA Technical Reports Server (NTRS)

1991-01-01

In FY 1991, the NASA Safety Division continued efforts to enhance the quality and productivity of its safety oversight function. Recent initiatives set forth in areas such as training, risk management, safety assurance, operational safety, and safety information systems have matured into viable programs contributing to the safety and success of activities throughout the Agency. Efforts continued to develop a centralized intra-agency safety training program with establishment of the NASA Safety Training Center at the Johnson Space Center (JSC). The objective is to provide quality training for NASA employees and contractors on a broad range of safety-related topics. Courses developed by the Training Center will be presented at various NASA locations to minimize travel and reach the greatest number of people at the least cost. In FY 1991, as part of the ongoing efforts to enhance the total quality of NASA's safety work force, the Safety Training Center initiated development of a Certified Safety Professional review course. This course provides a comprehensive review of the skills and knowledge that well-rounded safety professionals must possess to qualify for professional certification. FY 1992 will see the course presented to NASA and contractor employees at all installations via the NASA Video Teleconference System.

Innovative tools for quality assessment: integrated quality criteria for review of multiple study designs (ICROMS).

PubMed

Zingg, W; Castro-Sanchez, E; Secci, F V; Edwards, R; Drumright, L N; Sevdalis, N; Holmes, A H

2016-04-01

With the aim to facilitate a more comprehensive review process in public health including patient safety, we established a tool that we have termed ICROMS (Integrated quality Criteria for the Review Of Multiple Study designs), which unifies, integrates and refines current quality criteria for a large range of study designs including qualitative research. Review, pilot testing and expert consensus. The tool is the result of an iterative four phase process over two years: 1) gathering of established criteria for assessing controlled, non-controlled and qualitative study designs; 2) pilot testing of a first version in two systematic reviews on behavioural change in infection prevention and control and in antibiotic prescribing; 3) further refinement and adding of additional study designs in the context of the European Centre for Disease Prevention and Control funded project 'Systematic review and evidence-based guidance on organisation of hospital infection control programmes' (SIGHT); 4) scrutiny by the pan-European expert panel of the SIGHT project, which had the objective of ensuring robustness of the systematic review. ICROMS includes established quality criteria for randomised studies, controlled before-and-after studies and interrupted time series, and incorporates criteria for non-controlled before-and-after studies, cohort studies and qualitative studies. The tool consists of two parts: 1) a list of quality criteria specific for each study design, as well as criteria applicable across all study designs by using a scoring system; 2) a 'decision matrix', which specifies the robustness of the study by identifying minimum requirements according to the study type and the relevance of the study to the review question. The decision matrix directly determines inclusion or exclusion of a study in the review. ICROMS was applied to a series of systematic reviews to test its feasibility and usefulness in the appraisal of multiple study designs. The tool was applicable across a wide range of study designs and outcome measures. ICROMS is a comprehensive yet feasible appraisal of a large range of study designs to be included in systematic reviews addressing behaviour change studies in patient safety and public health. The tool is sufficiently flexible to be applied to a variety of other domains in health-related research. Beyond its application to systematic reviews, we envisage that ICROMS can have a positive effect on researchers to be more rigorous in their study design and more diligent in their reporting. Copyright © 2015 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Human factors systems approach to healthcare quality and patient safety

PubMed Central

Carayon, Pascale; Wetterneck, Tosha B.; Rivera-Rodriguez, A. Joy; Hundt, Ann Schoofs; Hoonakker, Peter; Holden, Richard; Gurses, Ayse P.

2013-01-01

Human factors systems approaches are critical for improving healthcare quality and patient safety. The SEIPS (Systems Engineering Initiative for Patient Safety) model of work system and patient safety is a human factors systems approach that has been successfully applied in healthcare research and practice. Several research and practical applications of the SEIPS model are described. Important implications of the SEIPS model for healthcare system and process redesign are highlighted. Principles for redesigning healthcare systems using the SEIPS model are described. Balancing the work system and encouraging the active and adaptive role of workers are key principles for improving healthcare quality and patient safety. PMID:23845724

Measuring patient safety in a UK dental hospital: development of a dental clinical effectiveness dashboard.

PubMed

Pemberton, M N; Ashley, M P; Shaw, A; Dickson, S; Saksena, A

2014-10-01

Patient safety is an important marker of quality for any healthcare organisation. In 2008, the British Government white paper entitled High quality care for all, resulting from a review led by Lord Darzi, identified patient safety as a key component of quality and discussed how it might be measured, analysed and acted upon. National and local clinically curated metrics were suggested, which could be displayed via a 'clinical dashboard'. This paper explains the development of a clinical effectiveness dashboard focused on patient safety in an English dental hospital and how it has helped us identify relevant patient safety issues in secondary dental care.

Improving Safety, Quality and Efficiency through the Management of Emerging Processes: The TenarisDalmine Experience

ERIC Educational Resources Information Center

Bonometti, Patrizia

2012-01-01

Purpose: The aim of this contribution is to describe a new complexity-science-based approach for improving safety, quality and efficiency and the way it was implemented by TenarisDalmine. Design/methodology/approach: This methodology is called "a safety-building community". It consists of a safety-behaviour social self-construction…

Total Quality Management and the System Safety Secretary

NASA Technical Reports Server (NTRS)

Elliott, Suzan E.

1993-01-01

The system safety secretary is a valuable member of the system safety team. As downsizing occurs to meet economic constraints, the Total Quality Management (TQM) approach is frequently adopted as a formula for success and, in some cases, for survival.

Modeling of endoluminal and interstitial ultrasound hyperthermia and thermal ablation: applications to device design, feedback control, and treatment planning

PubMed Central

Prakash, Punit; Salgaonkar, Vasant A.; Diederich, Chris J.

2014-01-01

Endoluminal and catheter-based ultrasound applicators are currently under development and are in clinical use for minimally invasive hyperthermia and thermal ablation of various tissue targets. Computational models play a critical role in in device design and optimization, assessment of therapeutic feasibility and safety, devising treatment monitoring and feedback control strategies, and performing patient-specific treatment planning with this technology. The critical aspects of theoretical modeling, applied specifically to endoluminal and interstitial ultrasound thermotherapy, are reviewed. Principles and practical techniques for modeling acoustic energy deposition, bioheat transfer, thermal tissue damage, and dynamic changes in the physical and physiological state of tissue are reviewed. The integration of these models and applications of simulation techniques in identification of device design parameters, development of real time feedback-control platforms, assessing the quality and safety of treatment delivery strategies, and optimization of inverse treatment plans are presented. PMID:23738697

Using Modified-ISS Model to Evaluate Medication Administration Safety During Bar Code Medication Administration Implementation in Taiwan Regional Teaching Hospital.

PubMed

Ma, Pei-Luen; Jheng, Yan-Wun; Jheng, Bi-Wei; Hou, I-Ching

2017-01-01

Bar code medication administration (BCMA) could reduce medical errors and promote patient safety. This research uses modified information systems success model (M-ISS model) to evaluate nurses' acceptance to BCMA. The result showed moderate correlation between medication administration safety (MAS) to system quality, information quality, service quality, user satisfaction, and limited satisfaction.

In-flight simulation of high agility through active control: Taming complexity by design

NASA Technical Reports Server (NTRS)

Padfield, Gareth D.; Bradley, Roy

1993-01-01

The motivation for research into helicopter agility stems from the realization that marked improvements relative to current operational types are possible, yet there is a dearth of useful criteria for flying qualities at high performance levels. Several research laboratories are currently investing resources in developing second generation airborne rotorcraft simulators. The UK's focus has been the exploitation of agility through active control technology (ACT); this paper reviews the results of studies conducted to date. The conflict between safety and performance in flight research is highlighted and the various forms of safety net to protect against system failures are described. The role of the safety pilot, and the use of actuator and flight envelope limiting are discussed. It is argued that the deep complexity of a research ACT system can only be tamed through a requirement specification assembled using design principles and cast in an operational simulation form. Work along these lines conducted at DRA is described, including the use of the Jackson System Development method and associated Ada simulation.

Quality and Safety in Health Care, Part XXI: PSOs and the Vascular Quality Initiative.

PubMed

Harolds, Jay A

2017-04-01

Congress provided for the formation of patient safety organizations (PSOs) so that physicians and other providers would come forward to improve the safety and quality of health care. Important legal safeguards for the providers and patients were put in place for PSOs. The Society for Vascular Surgery (SVS) PSO operates the Vascular Quality Initiative. The latter gathers information from certain commonly done vascular procedures. First, information is collected so a risk adjustment determination of each individual patient can be done. Then the details of every procedure are recorded for later analysis of the processes of the patient's care. In addition, outcome analysis from all procedures is carried out. This registry is an important source of data for research improving health care safety and quality.

Advance in quality assessment of Chinese materia medica using microscopic and morphological methods.

PubMed

Miao, Xiao-Su; Cui, Qing-Yu; Wang, Zhao-Yi; Liu, Xiao-Na; Zhao, An-Bang; Qiao, Yan-Jiang; Wu, Zhi-Sheng

2017-09-01

Quality evaluation plays a vital role in ensuring safety and effectiveness of Chinese materia medica (CMM). Microscopic and morphological technologies can be used to distinguish CMM's characteristics, such as shape, size, texture, section, and smell, for authenticity and quality control of CMM. The microscopic and morphological applications of novel micro-technology, colorimeter, and texture analyzer for CMM identification are summarized and the future prospect is discussed in this paper. Various styles and complex sources of CMM are systemically reviewed, including cormophyte medicinal materials, fruit and seeds, pollen grain, and spore materials. Copyright © 2017 China Pharmaceutical University. Published by Elsevier B.V. All rights reserved.

Use of Six Sigma strategies to pull the line on central line-associated bloodstream infections in a neurotrauma intensive care unit.

PubMed

Loftus, Kelli; Tilley, Terry; Hoffman, Jason; Bradburn, Eric; Harvey, Ellen

2015-01-01

The creation of a consistent culture of safety and quality in an intensive care unit is challenging. We applied the Six Sigma Define-Measure-Analyze-Improve-Control (DMAIC) model for quality improvement (QI) to develop a long-term solution to improve outcomes in a high-risk neurotrauma intensive care unit. We sought to reduce central line utilization as a cornerstone in preventing central line-associated bloodstream infections (CLABSIs). This study describes the successful application of the DMAIC model in the creation and implementation of evidence-based quality improvement designed to reduce CLABSIs to below national benchmarks.

Establishment of a New Quality Control and Vaccine Safety Test for Influenza Vaccines and Adjuvants Using Gene Expression Profiling

PubMed Central

Momose, Haruka; Mizukami, Takuo; Kuramitsu, Madoka; Takizawa, Kazuya; Masumi, Atsuko; Araki, Kumiko; Furuhata, Keiko; Yamaguchi, Kazunari; Hamaguchi, Isao

2015-01-01

We have previously identified 17 biomarker genes which were upregulated by whole virion influenza vaccines, and reported that gene expression profiles of these biomarker genes had a good correlation with conventional animal safety tests checking body weight and leukocyte counts. In this study, we have shown that conventional animal tests showed varied and no dose-dependent results in serially diluted bulk materials of influenza HA vaccines. In contrast, dose dependency was clearly shown in the expression profiles of biomarker genes, demonstrating higher sensitivity of gene expression analysis than the current animal safety tests of influenza vaccines. The introduction of branched DNA based-concurrent expression analysis could simplify the complexity of multiple gene expression approach, and could shorten the test period from 7 days to 3 days. Furthermore, upregulation of 10 genes, Zbp1, Mx2, Irf7, Lgals9, Ifi47, Tapbp, Timp1, Trafd1, Psmb9, and Tap2, was seen upon virosomal-adjuvanted vaccine treatment, indicating that these biomarkers could be useful for the safety control of virosomal-adjuvanted vaccines. In summary, profiling biomarker gene expression could be a useful, rapid, and highly sensitive method of animal safety testing compared with conventional methods, and could be used to evaluate the safety of various types of influenza vaccines, including adjuvanted vaccine. PMID:25909814

What is Taught on Firearm Safety in Undergraduate, Graduate, and Continuing Medical Education? A Review of Educational Programs.

PubMed

Puttagunta, R; Coverdale, T R; Coverdale, J

2016-10-01

Because there have been no published formal reviews on teaching of firearm safety, we set out to systematically locate and review the literature on curricula that educated physicians and other health care providers, residents across specialties, and medical students on how to counsel on firearm safety. We searched for all papers with outcomes that described firearm safety training programs for healthcare providers and trainees. Studies were identified through PubMed, Scopus, Google Scholar, PsychInfo, EMBASE, and MedEdPortal databases and electronically searched using combinations of words from general topic areas of firearms, learners, and education. We found four programs that met inclusion criteria. These targeted a narrow range of learners including medical students, pediatric residents, practicing pediatricians, and nurse practitioners. Teaching methods included lectures, case-based learning, group discussions, and audiotape training. There were two randomized controlled trials, one cohort design, and one posttest design. One of the randomized controlled trials was an office-based high quality multisite national study, although the focus of teaching was not on firearm safety alone. All studies used different outcomes, and only one study validated the outcome measures. There were no studies targeting psychiatrists or psychiatry residents. These results underscore a priority for developing firearm safety education programs in undergraduate, graduate, and continuing medical education settings.

A modern depleted uranium manufacturing facility

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

Zagula, T.A.

1995-07-01

The Specific Manufacturing Capabilities (SMC) Project located at the Idaho National Engineering Laboratory (INEL) and operated by Lockheed Martin Idaho Technologies Co. (LMIT) for the Department of Energy (DOE) manufactures depleted uranium for use in the U.S. Army MIA2 Abrams Heavy Tank Armor Program. Since 1986, SMC has fabricated more than 12 million pounds of depleted uranium (DU) products in a multitude of shapes and sizes with varying metallurgical properties while maintaining security, environmental, health and safety requirements. During initial facility design in the early 1980`s, emphasis on employee safety, radiation control and environmental consciousness was gaining momentum throughout themore » DOE complex. This fact coupled with security and production requirements forced design efforts to focus on incorporating automation, local containment and computerized material accountability at all work stations. The result was a fully automated production facility engineered to manufacture DU armor packages with virtually no human contact while maintaining security, traceability and quality requirements. This hands off approach to handling depleted uranium resulted in minimal radiation exposures and employee injuries. Construction of the manufacturing facility was complete in early 1986 with the first armor package certified in October 1986. Rolling facility construction was completed in 1987 with the first certified plate produced in the fall of 1988. Since 1988 the rolling and manufacturing facilities have delivered more than 2600 armor packages on schedule with 100% final product quality acceptance. During this period there was an annual average of only 2.2 lost time incidents and a single individual maximum radiation exposure of 150 mrem. SMC is an example of designing and operating a facility that meets regulatory requirements with respect to national security, radiation control and personnel safety while achieving production schedules and product quality.« less

An Open-Label, Analgesic Efficacy and Safety of Pituitary Radiosurgery for Patients With Opioid-Refractory Pain: Study Protocol for a Randomized Controlled Trial.

PubMed

Borius, Pierre-Yves; Garnier, Stéphanie Ranque; Baumstarck, Karine; Castinetti, Frédéric; Donnet, Anne; Guedj, Eric; Cornu, Philippe; Blond, Serge; Salas, Sébastien; Régis, Jean

2017-08-02

Hypophysectomy performed by craniotomy or percutaneous techniques leads to complete pain relief in more than 70% to 80% of cases for opioid refractory cancer pain. Radiosurgery could be an interesting alternative approach to reduce complications. To assess the analgesic efficacy compared with standard of care is the primary goal. The secondary objectives are to assess ophthalmic and endocrine tolerance, drug consumption, quality of life, and mechanisms of analgesic action. The trial is multicenter, randomized, prospective, and open-label with 2 parallel groups. This concerns patients in palliative care suffering from nociceptive or mixed cancer pain, refractory to standard opioid therapy. Participants will be randomly assigned to the control group receiving standards of care for pain according to recommendations, or to the experimental group receiving a pituitary GammaKnife (Elekta, Stockholm, Sweden) radiosurgery (160 Gy delivered in pituitary gland) associated with standards of care. Evaluation assessments will be taken at baseline, day0, day4, day7, day14, day28, day45, month3, and month6. We could expect pain improvement in 70% to 90% of cases at day4. In addition we will assess the safety of pituitary radiosurgery in a vulnerable population. The secondary endpoints could show decay of opioid consumption, good patient satisfaction, and improvement of the quality of life. The design of this study is potentially the most appropriate to demonstrate the efficacy and safety of radiosurgery for this new indication. New recommendations could be obtained in order to improve pain relief and quality of life. Copyright © 2017 by the Congress of Neurological Surgeons

Quality improvement for patient safety: project-level versus program-level learning.

PubMed

Rivard, Peter E; Parker, Victoria A; Rosen, Amy K

2013-01-01

Improving quality and patient safety is of increasing strategic importance to health care organizations. However, simply increasing the volume of quality improvement (QI) activity does not necessarily improve patient outcomes. There is a need for greater understanding of QI success factors. This study looked for differences in QI implementation across hospitals with a range of performance on Patient Safety Indicators. We conducted an exploratory comparative case study of 4 Veterans Health Administration hospitals including site visits and interviews with leaders and staff. Two themes emerged. Project-level QI learning is assessing and modifying specific QI projects relative to expectations. Program-level QI learning is assessing and modifying the overall QI endeavor. The nature of project-level QI learning was similar across sites, whereas we identified qualitative differences across organizations in program-level QI learning. The highest performing organization was evaluating and refining its overall approach to QI, whereas the others were learning how to build and control QI programs. Program-level QI learning may be key if a QI program is to succeed in improving patient outcomes. This type of organizational learning entails a big-picture, organization-wide view of QI. It also entails second-order organizational learning based on assessment not only of whether QI is being done correctly but also whether the right QI activities are being done, for the right reasons. The organization is "learning to learn." In addition to gaining mastery and control of QI, leaders regularly engage with staff in rethinking QI and experimenting with new approaches. Leaders also assess how QI activity fits in the organization's developmental journey and how it supports realization of strategy.

Efficacy and Safety of the Traditional Herbal Medicine, Gamiguibi-tang, in Patients With Cancer-Related Sleep Disturbance: A Prospective, Randomized, Wait-List-Controlled, Pilot Study.

PubMed

Lee, Jee Young; Oh, Hye Kyung; Ryu, Han Sung; Yoon, Sung Soo; Eo, Wankyu; Yoon, Seong Woo

2018-06-01

Sleep disturbance is the second most bothersome symptom in patients with cancer, and it can significantly impair their quality of life. The aim of this study was to investigate the efficacy and safety of the traditional herbal medicine Gamiguibi-tang (GGBT) in patients with cancer-related sleep disturbance. We conducted a prospective, randomized, wait-list-controlled, open-label pilot clinical trial on cancer-related sleep disturbance. Patients with cancer experiencing poor sleep quality with a Pittsburgh Sleep Quality Index of at least 6 were randomly assigned to the GGBT and wait-list groups to receive GGBT and conventional care, respectively, for 2 weeks. The primary endpoint was the Insomnia Severity Index (ISI) score. Fatigue, depression, and cognitive impairment were assessed as the secondary endpoints by using the Brief Fatigue Inventory (BFI), Beck Depression Inventory (BDI), and Montreal Cognitive Assessment (MoCA). Thirty participants who met the eligibility criteria were enrolled. Sleep disturbance assessed using the ISI improved significantly more in the GGBT group than in the wait-list group (-5.5 ± 4.4 vs 0.1 ± 1.1, P < .001). Fatigue level determined using the BFI also improved significantly more in the GGBT group than in the wait-list group (-0.8 ± 0.8 vs 0.0 ± 0.3, P = .002). The BDI and MoCA scores showed no significant changes. Adverse events were reported in two patients in the GGBT group and consisted of mild dyspepsia and mild edema. GGBT may be a potential treatment option for cancer-related sleep disturbance. Further research is needed to investigate the efficacy and safety of GGBT.

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 influencing contextual factors, including providing resources, developing culture, and taking strategic actions that support improvement. Our review highlights the importance of leadership in both promoting a supportive learning environment and implementing learning processes.

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 influencing contextual factors, including providing resources, developing culture, and taking strategic actions that support improvement. Our review highlights the importance of leadership in both promoting a supportive learning environment and implementing learning processes. PMID:29355197

Antiretroviral therapy supply chain quality control and assurance in improving people living with HIV therapeutic outcomes in Cameroon.

PubMed

Djobet, M P Ngogang; Singhe, David; Lohoue, Julienne; Kuaban, Christopher; Ngogang, Jeanne; Tambo, Ernest

2017-04-04

Evaluation of medication efficacy and safety is an essential guarantee to successful therapeutic outcome in public health practices. However, larger distribution chain supply in developing countries such as Cameroon is often challenged by counterfeit drugs, poor manufacturing, storage and degradation leading to health and patient adverse consequences. Yet, access to supply chain management in strengthening ARVs quality assurance and outcomes remains poorly documented. More than 53,000 patients have been enrolled on free ARVs medications, but little is documented on quality assurance and validity of safety for affected populations along the supply chain management since 2008. The cross sectional study was conducted in ARVs distribution units and centers in central, littoral and south west regions of Cameroon. ARVs drugs samples included Nevirapine, Efavirenz, and fixed dose combinations of Zidovudine + Lamivudine, Lamivudine + Stavudine and Zidovudine + Lamivudine + Nevirapine. Drugs packaging and labeling was assessed and galenic assays were performed at National Laboratory of quality Control of Medications and Expertise (LANACOME), Yaoundé, Cameroon. The study covered 16 structures located in eight different towns including the central ARVs store, two regional pharmaceutical procurement centers and thirteen HIV approved treatment centers and management units. A total of 35 ARVs products were collected. Only eight ARVs drugs containing Lamivudine and Stavudine presented with white stains on tablets, however these drugs were standard for all other tests performed. The others 28 ARVs products were standards to all assays performed. We concluded that ARVs drugs freely accessible and distributed to PLWHA are of good quality in Cameroon. However, with the increase number of patients under HAART since 2013, adoption of "Test and Treat" approach to reach the 90-90-90 goals and with the implementation of new national antiretroviral regimen guidelines and molecules such as boosted protease inhibitors, continuous quality control and assurance surveillance, monitoring and evaluation is recommended. Assessment of quality of formulations that are more susceptible to degradation such as pediatric formulations for averting the rising multidrug resistance trend is also desired.

Chemical and microbiological experimentation for development of environmental control and life support systems

NASA Technical Reports Server (NTRS)

Whitman, G. A.; Wilson, M. E.; Cole, H. E.; Traweek, M.

1992-01-01

Microbiological techniques are under study with a view to the identification of viable microorganisms in liquid cultures, improve the identification of stressed organisms, and determine the biocidal activity of iodine and other chemicals on isolates from recycled water. A quality-assurance program has been implemented to validate data employed in making decisions concerning engineering and human health and safety. Analytical laboratory refinements will strongly aid the development of environmental control and life-support systems.

Opinions on Fresh Produce Food Safety and Quality Standards by Fresh Produce Supply Chain Experts from the Global South and North.

PubMed

Jacxsens, Liesbeth; Van Boxstael, Sigrid; Nanyunja, Jessica; Jordaan, Danie; Luning, Pieternel; Uyttendaele, Mieke

2015-10-01

This study describes the results of an on-line survey of fresh produce supply chain experts who work with producers from the Global North (n = 41, 20 countries) and the Global South (n = 63, 29 countries). They expressed their opinion using 1 to 5 Likert scales on several items related to four types of food safety and quality standards and legislation: Codex Alimentarius standards, European Union legislation, national legislation, and private standards. The results reflect the different circumstances under which the Southern and Northern producers operate in relation to the local organization, regulation, and support of the sector; but they also indicate similar challenges, in particular, the challenge of private standards, which were perceived to demand a higher implementation effort than the other three types of standards. Private standards were also strongly perceived to exclude Southern and Northern small- and medium-scale producers from high-value markets, whereas European Union legislation was perceived to strongly exclude, in particular, small- and medium-scale Southern producers. The results further highlight concerns about costly control measures and third-party certification that are required by downstream buyers but that are mostly paid for by upstream suppliers. Food standards are seen in their dual role as a catalyst for implementation of structured food safety management systems on the one hand and as a nontariff barrier to trade on the other hand. The results of the survey also pointed up the advantages of enforcing food safety and food quality standards in terms of knowledge spillover to noncertified activities, increased revenues, and improved food safety of delivered produce. Survey results highlight the importance of technical assistance and support of producers by governments and producer cooperatives or trade associations in the implementation and certification of food standards, along with increased awareness of and training of individuals in food protection practices to ensure food safety.

42 CFR 482.21 - Condition of participation: Quality assessment and performance improvement program.

Code of Federal Regulations, 2013 CFR

2013-10-01

... quality improvement and patient safety, including the reduction of medical errors, is defined, implemented... address priorities for improved quality of care and patient safety; and that all improvement actions are... incorporate quality indicator data including patient care data, and other relevant data, for example...

42 CFR 482.21 - Condition of participation: Quality assessment and performance improvement program.

Code of Federal Regulations, 2014 CFR

2014-10-01

... quality improvement and patient safety, including the reduction of medical errors, is defined, implemented... address priorities for improved quality of care and patient safety; and that all improvement actions are... incorporate quality indicator data including patient care data, and other relevant data, for example...

42 CFR 482.21 - Condition of participation: Quality assessment and performance improvement program.

Code of Federal Regulations, 2012 CFR

2012-10-01

... quality improvement and patient safety, including the reduction of medical errors, is defined, implemented... address priorities for improved quality of care and patient safety; and that all improvement actions are... incorporate quality indicator data including patient care data, and other relevant data, for example...

New challenges in assuring vaccine quality.

PubMed Central

Dellepiane, N.; Griffiths, E.; Milstien, J. B.

2000-01-01

In the past, quality control of vaccines depended on use of a variety of testing methods to ensure that the products were safe and potent. These methods were developed for vaccines whose safety and efficacy were based on several years worth of data. However, as vaccine production technologies have developed, so have the testing technologies. Tests are now able to detect potential hazards with a sensitivity not possible a few years ago, and an increasing array of physicochemical methods allows a much better characterization of the product. In addition to sophisticated tests, vaccine regulation entails a number of other procedures to ensure safety. These include characterization of starting materials by supplier audits, cell banking, seed lot systems, compliance with the principles of good manufacturing practices, independent release of vaccines on a lot-by-lot basis by national regulatory authorities, and enhanced pre- and post-marketing surveillance for possible adverse events following immunization. These procedures help assure vaccine efficacy and safety, and some examples are given in this article. However, some contaminants of vaccines that can be detected by newer assays raise theoretical safety concerns but their presence may be less hazardous than not giving the vaccines. Thus risk-benefit decisions must be well informed and based on scientific evidence. PMID:10743279

Food Safety and Quality. Uniform, Risk-Based Inspection System Needed to Ensure Safe Food Supply,

DTIC Science & Technology

1992-06-01

Concerned about the effectiveness of the federal food safety inspection system, the Chairman, Subcommittee on Oversight and Investigations, House...federal resources for inspection, and (3) agencies are effectively coordinating their food safety and quality inspection efforts.

The REFLECT statement: methods and processes of creating reporting guidelines for randomized controlled trials for livestock and food safety.

PubMed

O'Connor, A M; Sargeant, J M; Gardner, I A; Dickson, J S; Torrence, M E; Dewey, C E; Dohoo, I R; Evans, R B; Gray, J T; Greiner, M; Keefe, G; Lefebvre, S L; Morley, P S; Ramirez, A; Sischo, W; Smith, D R; Snedeker, K; Sofos, J; Ward, M P; Wills, R

2010-01-01

The conduct of randomized controlled trials in livestock with production, health, and food-safety outcomes presents unique challenges that might not be adequately reported in trial reports. The objective of this project was to modify the CONSORT (Consolidated Standards of Reporting Trials) statement to reflect the unique aspects of reporting these livestock trials. A 2-day consensus meeting was held on November 18-19, 2008 in Chicago, IL, to achieve the objective. Before the meeting, a Web-based survey was conducted to identify issues for discussion. The 24 attendees were biostatisticians, epidemiologists, food-safety researchers, livestock production specialists, journal editors, assistant editors, and associate editors. Before the meeting, the attendees completed a Web-based survey indicating which CONSORT statement items would need to be modified to address unique issues for livestock trials. The consensus meeting resulted in the production of the REFLECT (Reporting Guidelines for Randomized Control Trials) statement for livestock and food safety and 22-item checklist. Fourteen items were modified from the CONSORT checklist, and an additional subitem was proposed to address challenge trials. The REFLECT statement proposes new terminology, more consistent with common usage in livestock production, to describe study subjects. Evidence was not always available to support modification to or inclusion of an item. The use of the REFLECT statement, which addresses issues unique to livestock trials, should improve the quality of reporting and design for trials reporting production, health, and food-safety outcomes.

Novel Driving Control of Power Assisted Wheelchair Based on Minimum Jerk Trajectory

NASA Astrophysics Data System (ADS)

Seki, Hirokazu; Sugimoto, Takeaki; Tadakuma, Susumu

This paper describes a novel trajectory control scheme for power assisted wheelchair. Human input torque patterns are always intermittent in power assisted wheelchairs, therefore, the suitable trajectories must be generated also after the human decreases his/her input torque. This paper tries to solve this significant problem based on minimum jerk model minimizing the changing rate of acceleration. The proposed control system based on minimum jerk trajectory is expected to improve the ride quality, stability and safety. Some experiments show the effectiveness of the proposed method.

Safety culture and care: a program to prevent surgical errors.

PubMed

Hemingway, Maureen White; O'Malley, Catherine; Silvestri, Sandra

2015-04-01

Surgical errors are under scrutiny in health care as part of ensuring a culture of safety in which patients receive quality care. Hospitals use safety measures to compare their performance against industry benchmarks. To understand patient safety issues, health care providers must have processes in place to analyze and evaluate the quality of the care they provide. At one facility, efforts made to improve its quality and safety led to the development of a robust safety program with resources devoted to enhancing the culture of safety in the Perioperative Services department. Improvement initiatives included changing processes for safety reporting and performance improvement plans, adding resources and nurse roles, and creating communication strategies around adverse safety events and how to improve care. One key outcome included a 54% increase in the percentage of personnel who indicated in a survey that they would speak up if they saw something negatively affecting patient care. Copyright © 2015 AORN, Inc. Published by Elsevier Inc. All rights reserved.

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.

Mission impossible? Regulatory and enforcement issues to ensure safety of dietary supplements.

PubMed

Petroczi, A; Taylor, G; Naughton, D P

2011-02-01

Dietary supplements are widely used across all ages and user groups and constitute a considerable business sector in most developed countries. Hazards relating to concentration, composition, individual contaminants and supplement interactions present an increasing public health concern. The aim of this paper is to review the literature for reported supplement contaminations (occurs in ca 25% of supplements, with anabolic steroids being the most common) and complement these findings with notifications logged in the EU's Rapid Alert System for Food and Feed (RASFF) through imports or market surveillance, typically logged for poor quality control issues. Notifications in the RASFF have steadily increased by sixfold for supplements in the past 7 years with the USA and China being the major transgressors. Finland and Italy lead in detections, mainly notifying unpermitted substances and contaminants in sexual-enhancing or weight-loss supplements. This paper highlights the paucity of enforcement. Regulating supplements as a foodstuff and not a medicine, coupled with the fact that a significant proportion of the supplement market is distributed via the Internet (hence absent from routine border control and surveillance), make ensuring and enforcing safety a very challenging task. The need for better quality control, compliance and public awareness is evident. Copyright © 2010 Elsevier Ltd. All rights reserved.

Multi-component determination and chemometric analysis of Paris polyphylla by ultra high performance liquid chromatography with photodiode array detection.

PubMed

Chen, Pei; Jin, Hong-Yu; Sun, Lei; Ma, Shuang-Cheng

2016-09-01

Multi-source analysis of traditional Chinese medicine is key to ensuring its safety and efficacy. Compared with traditional experimental differentiation, chemometric analysis is a simpler strategy to identify traditional Chinese medicines. Multi-component analysis plays an increasingly vital role in the quality control of traditional Chinese medicines. A novel strategy, based on chemometric analysis and quantitative analysis of multiple components, was proposed to easily and effectively control the quality of traditional Chinese medicines such as Chonglou. Ultra high performance liquid chromatography was more convenient and efficient. Five species of Chonglou were distinguished by chemometric analysis and nine saponins, including Chonglou saponins I, II, V, VI, VII, D, and H, as well as dioscin and gracillin, were determined in 18 min. The method is feasible and credible, and enables to improve quality control of traditional Chinese medicines and natural products. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Quality improvement of interdisciplinary rounds by leadership training based on essential quality indicators of the Interdisciplinary Rounds Assessment Scale.

PubMed

Ten Have, Elsbeth C M; Nap, Raoul E; Tulleken, Jaap E

2013-10-01

The implementation of interdisciplinary teams in the intensive care unit (ICU) has focused attention on leadership behavior. Daily interdisciplinary rounds (IDRs) in ICUs integrate leadership behavior and interdisciplinary teamwork. The purpose of this intervention study was to measure the effect of leadership training on the quality of IDRs in the ICU. A nonrandomized intervention study was conducted in four ICUs for adults. The intervention was a 1-day training session in a simulation environment and workplace-based feedback sessions. Measurement included 28 videotaped IDRs (total, 297 patient presentations) that were assessed with 10 essential quality indicators of the validated IDR Assessment Scale. Participants were 19 intensivists who previously had no formal training in leading IDRs. They were subdivided by cluster sampling into a control group (ten experienced intensivists) and intervention group (nine intensive care fellows). Mann-Whitney U test was used to compare results between control and intervention groups. Baseline measurements of control and intervention groups revealed two indicators that differed significantly. The frequency of yes ratings for the intervention group significantly increased for seven of the ten indicators from before to after intervention. The frequency of yes ratings after training was significantly greater in the intervention than control groups for eight of the ten essential quality indicators. The leadership training improved the quality of the IDRs performed in the ICUs. This may improve quality and safety of patient care.

[Endorsement of risk management and patient safety by certification of conformity in health care quality assessment].

PubMed

Waßmuth, Ralf

2015-01-01

Certification of conformity in health care should provide assurance of compliance with quality standards. This also includes risk management and patient safety. Based on a comprehensive definition of quality, beneficial effects on the management of risks and the enhancement of patient safety can be expected from certification of conformity. While these effects have strong face validity, they are currently not sufficiently supported by evidence from health care research. Whether this relates to a lack of evidence or a lack of investigation remains open. Advancing safety culture and "climate", as well as learning from adverse events rely in part on quality management and are at least in part reflected in the certification of healthcare quality. However, again, evidence of the effectiveness of such measures is limited. Moreover, additional factors related to personality, attitude and proactive action of healthcare professionals are crucial factors in advancing risk management and patient safety which are currently not adequately reflected in certification of conformity programs.

Runoff delay exerts a strong control on the field-scale removal of manure-borne fecal bacteria with runoff

USDA-ARS?s Scientific Manuscript database

The microbial safety of surface waters is an ongoing issue which is threatened by the transport of manure-borne bacteria to water sources used for irrigation or recreation. Predictive modeling has become an effective tool to forecast the microbial quality of water during precipitation events, howeve...

Timber marking guidelines to minimize chainsaw felling accidents

Treesearch

Penn A. Peters; Michael D. Erickson; Curt D. Hassler

1995-01-01

Trees are marked by foresters for retention or harvest to satisfy landowner objectives for timber sale revenues, stand improvement, wildlife habitat, water quality, and aesthetics. Another consideration when marking trees is the safety of the chainsaw feller. Can the tree that has been marked for harvest be felled safely? Will the feller be able to select and control a...

Development and Exchange of Instructional Resources in Water Quality Control Programs, III: Selecting Audio-Visual Equipment.

ERIC Educational Resources Information Center

Moon, Donald K.

This document is one in a series of reports which reviews instructional materials and equipment and offers suggestions about how to select equipment. Topics discussed include: (1) the general criteria for audio-visual equipment selection such as performance, safety, comparability, sturdiness and repairability; and (2) specific equipment criteria…

Performance Assessment in CTE: Focusing on the Cognitive, Psychomotor ...and Affective Domains

ERIC Educational Resources Information Center

Washer, Bart; Cochran, Lori

2012-01-01

When a student is performing in the psychomotor domain, the authors believe the student is also performing in the cognitive domain (sequencing steps, evaluating the situation) and in the affective domain (appreciating a job well done, quality control, safety). As Dabney Doty, former instructor at the University of Central Missouri, stated, "There…

Negotiating the Context of Online In-Service Training: "Expert" and "Non-Expert" Footings

ERIC Educational Resources Information Center

Nilsen, Mona

2010-01-01

This paper focuses on how people working in the Swedish food production industry engage in in-service training by means of computer-mediated communication. The empirical material consists of archived chat log files from a course concerning quality assurance and food safety hazards control in the preparation and handling of foodstuff. Drawing on…

2009 Mississippi Curriculum Framework: Postsecondary Occupational Safety and Health Technology. Program CIP: 15.0701

ERIC Educational Resources Information Center

Flowers, Walter M.

2009-01-01

As the world economy continues to evolve, businesses and industries must adopt new practices and processes in order to survive. Quality and cost control, work teams and participatory management, and an infusion of technology are transforming the way people work and do business. Employees are now expected to read, write, and communicate…

[Demonstrating patient safety requires acceptance of a broader scientific palette].

PubMed

Leistikow, I

2017-01-01

It is high time the medical community recognised that patient-safety research can be assessed using other scientific methods than the traditional medical ones. There is often a fundamental mismatch between the methodology of patient-safety research and the methodology used to assess the quality of this research. One example is research into the reliability and validity of record review as a method for detecting adverse events. This type of research is based on logical positivism, while record review itself is based on social constructivism. Record review does not lead to "one truth": adverse events are not measured on the basis of the records themselves, but by weighing the probability of certain situations being classifiable as adverse events. Healthcare should welcome behavioural and social sciences to its scientific palette. Restricting ourselves to the randomised control trial paradigm is short-sighted and dangerous; it deprives patients of much-needed improvements in safety.