WorldWideScience

Sample records for assuring blood safety

  1. Air Operators’ Safety Assurance System

    Directory of Open Access Journals (Sweden)

    Xie Zhi-Hui

    2017-01-01

    Full Text Available Construction of air operators’ safety assurance system is important for national civil aviation authority to perform the safety oversight work systematically and efficiently on the air operators. The system is a combination of management process, tools, information platform, which utilize system configuration model and data collection tools to accomplish the air operator system design evaluation and performance evaluation, and output the advice for national civil aviation authority inspectors to take action to improve the air operators’ safety design and performance according to the regulation. Process has been designed to realize design and performance evaluation, and strengthen the safety assurance function during the air operator certification and surveillance phases. Based on the system configuration model, risk indicators, data collection tools and other tools, the system could perform configuration setting, planning, task assignment, data collection, analysis and action during the certification and surveillance. The application of the safety assurance system to different operators has been considered.

  2. GSFC Safety and Mission Assurance Organization

    Science.gov (United States)

    Kelly, Michael P.

    2010-01-01

    This viewgraph presentation reviews NASA Goddard Space Flight Center's approach to safety and mission assurance. The contents include: 1) NASA GSFC Background; 2) Safety and Mission Assurance Directorate; 3) The Role of SMA-D and the Technical Authority; 4) GSFC Mission assurance Requirements; 5) GSFC Systems Review Office (SRO); 6) GSFC Supply Chain Management Program; and 7) GSFC ISO9001/AS9100 Status Brief.

  3. Assuring bridge safety and serviceability in Europe

    Science.gov (United States)

    2010-08-01

    U.S. engineers need advanced tools and protocols to better assess and assure safety and serviceability of bridges. The Federal Highway Administration, American Association of State Highway and Transportation Officials, and National Cooperative Highwa...

  4. Causal Models for Safety Assurance Technologies Project

    Data.gov (United States)

    National Aeronautics and Space Administration — Fulfillment of NASA's System-Wide Safety and Assurance Technology (SSAT) project at NASA requires leveraging vast amounts of data into actionable knowledge. Models...

  5. Assuring NASA's Safety and Mission Critical Software

    Science.gov (United States)

    Deadrick, Wesley

    2015-01-01

    What is IV&V? Independent Verification and Validation (IV&V) is an objective examination of safety and mission critical software processes and products. Independence: 3 Key parameters: Technical Independence; Managerial Independence; Financial Independence. NASA IV&V perspectives: Will the system's software: Do what it is supposed to do?; Not do what it is not supposed to do?; Respond as expected under adverse conditions?. Systems Engineering: Determines if the right system has been built and that it has been built correctly. IV&V Technical Approaches: Aligned with IEEE 1012; Captured in a Catalog of Methods; Spans the full project lifecycle. IV&V Assurance Strategy: The IV&V Project's strategy for providing mission assurance; Assurance Strategy is driven by the specific needs of an individual project; Implemented via an Assurance Design; Communicated via Assurance Statements.

  6. Globalisation and blood safety.

    Science.gov (United States)

    Farrugia, Albert

    2009-05-01

    Globalisation may be viewed as the growing interdependence of countries worldwide through the increasing volume and variety of cross-border transactions in goods and services, and also through the more rapid and widespread diffusion of technology. Globalisation is not just an economic phenomenon, although it is frequently described as such, but includes commerce, disease and travel, and immigration, and as such it affects blood safety and supply in various ways. The relatively short travel times offered by modern aviation can result in the rapid spread of blood-borne pathogens before measures to counteract transmission can be put in place; this would have happened with SARS if the basic life cycle of the SARS virus included an asymptomatic viraemia. This risk can be amplified by ecological factors which effect the spread of these pathogens once they are transferred to a naïve ecosystem, as happened with West Nile Virus (WNV) in North America. The rationalization and contraction of the plasma products industry may be viewed as one aspect of globalisation imposed by the remorseless inevitability of the market; the effect of this development on the safety and supply of products has yet to be seen, but the oversight and assurance of a shrinking number of players will present particular challenges. Similarly, the monopolization of technology, through patent enforcement which puts access beyond the reach of developing countries, can have an effect on blood safety. The challenges presented to blood safety by globalisation are heightening the tensions between the traditional focus on the product safety - zero risk paradigm and the need to view the delivery of safe blood as an integrated process. As an illustration of this tension, donor deferral measures imposed by globalisation-induced risks such as vCJD and WNV have resulted in the loss of the safest and most committed portion of the blood donor population in many Western countries, leading to an increased risk to

  7. Comprehensive Lifecycle for Assuring System Safety

    Science.gov (United States)

    Knight, John C.; Rowanhill, Jonathan C.

    2017-01-01

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

  8. Safety Assurance Process for FRMS : EJcase Implementation

    NARCIS (Netherlands)

    Stewart, S.; Koornneef, F.; Akselsson, R.; Barton, P.

    2009-01-01

    Chapter 6: Safety Assurance Process for FRMS - eJcase Implementation The European Commission HILAS project (Human Integration into the Lifecycle of Aviation Systems - a project supported by the European Commission’s 6th Framework between 2005-2009) was focused on using human factors knowledge and

  9. Safety and Mission Assurance Knowledge Management Retention

    Science.gov (United States)

    Johnson, Teresa A.

    2006-01-01

    This viewgraph presentation reviews the issues surrounding the management of knowledge in regards to safety and mission assurance. The JSC workers who were hired in the 1960's are slated to retire in the next two to three years. The experiences and knowledge of these NASA workers must be identified, and disseminated. This paper reviews some of the strategies that the S&MA is developing to capture that valuable institutional knowledge.

  10. Integrating Safety and Mission Assurance in Design

    Science.gov (United States)

    Cianciola, Chris; Crane, Kenneth

    2008-01-01

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

  11. 78 FR 54510 - New Entrant Safety Assurance Program Operational Test

    Science.gov (United States)

    2013-09-04

    ... TRANSPORTATION Federal Motor Carrier Safety Administration New Entrant Safety Assurance Program Operational Test... Motor Carrier Safety Administration (FMCSA) announces an operational test of procedural changes to the New Entrant Safety Assurance Program. The operational test began in July 2013 and will be in effect...

  12. Food safety and quality assurance : foods of animal origin

    National Research Council Canada - National Science Library

    Hughes, Keith L; Hinton, Michael H; Hubbert, William T; Hagstad, Harry V; Spangler, Elizabeth

    1996-01-01

    The second edition of Food Safety and Quality Assurance is a basic reference for veterinarians, extension specialists, and others who help food-animal producers throughout the food chain to provide...

  13. Changing the Safety and Mission Assurance (S and MA) Paradigm

    Science.gov (United States)

    Malone, Roy W.; Safie, Fayssal M.

    2010-01-01

    This slide presentation reviews the change in the work and impact of the Safety and Mission Assurance directorate at Marshall Space Flight Center. It reviews the background and the reasons given for a strong Safety & Mission Assurance presence in all planning for space flight. This was pointed out by the Rogers Commission Report after the Space Challenger accident, by the Columbia Accident Investigation Board (CAIB) and by a 2006 NASA Exploration Safety Study (NESS) Team. The overall objective of the work in this area was to improve and maintain S&MA expertise and skills. Training for this work was improved and the S&MA organization was reorganized. This has resulted in a paradigm shift for NASA's safety efforts, which is described. The presentation then reviews the impact of the new S&MA work in the Ares I design and development.

  14. Safety and Mission Assurance: A NASA Perspective

    Science.gov (United States)

    Higginbotham, Scott A.

    2016-01-01

    Manned spaceflight is an incredibly complex and inherently risky human endeavor. As the result of the lessons learned through years of triumph and tragedy, the National Aeronautics and Space Administration (NASA) has embraced a comprehensive and integrated approach to the challenge of ensuring safety and mission success. This presentation will provide an overview of some of the techniques employed in this effort, with a focus on the processing operations performed at the Kennedy Space Center (KSC).

  15. Safer electronic health records safety assurance factors for EHR resilience

    CERN Document Server

    Sittig, Dean F

    2015-01-01

    This important volume provide a one-stop resource on the SAFER Guides along with the guides themselves and information on their use, development, and evaluation. The Safety Assurance Factors for EHR Resilience (SAFER) guides, developed by the editors of this book, identify recommended practices to optimize the safety and safe use of electronic health records (EHRs). These guides are designed to help organizations self-assess the safety and effectiveness of their EHR implementations, identify specific areas of vulnerability, and change their cultures and practices to mitigate risks.This book pr

  16. Changing the S and MA [Safety and Mission Assurance] Paradigm

    Science.gov (United States)

    Malone, Roy W., Jr.

    2010-01-01

    Objectives: 1) Optimize S&MA organization to best facilitate Shuttle transition in 2010, successfully support Ares developmental responsibilities, and minimize the impacts of the gap between last Shuttle flight and start of Ares V Project. 2) Improve leveraging of critical skills and experience between Shuttle and Ares. 3) Split technical and supervisory functions to facilitate technical penetration. 4) Create Chief Safety and Mission Assurance Officer (CSO) stand-alone position for successfully implementation of S&MA Technical Authority. 5) Minimize disruption to customers. 6) Provide early involvement of S&MA leadership team and frequent/open communications with S&MA team members and steak-holders.

  17. Assuring fish safety and quality in international fish trade

    Energy Technology Data Exchange (ETDEWEB)

    Ababouch, Lahsen [United Nations, Food and Agricultural Organization, Chief, Fish Utilization and Marketing Services, FAO Headquarters, F-607 Rome (Italy)]. E-mail lahsen.ababouch@fao.org

    2006-07-01

    International trade in fishery commodities reached US$ 58.2 billion 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 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.

  18. Work Done For the Safety and Assurance Directorate

    Science.gov (United States)

    Struhar, Paul T., Jr.

    2004-01-01

    The Safety and Assurance Directorate (SAAD) has a vision. The vision is to be an essential part of NASA Glenn's journey to excellence. SAAD is in charge of leading safety, security, and quality and is important to our customers. When it comes to programmatic and technical decision making and implementation, SAAD provides clear safety, reliability, maintainable, quality assurance and security. I worked on a couple different things during my internship with Sandra Hardy. I did a lot of logistics for meeting and trips. I helped run the budget for the SAAD directorate. I also worked with Rich Miller for one week and we took water samples and ran tests. We also calibrated the different equipment. There is a lot more to meetings than people see. I did one for a retirement party. I had to get work orders and set up the facilities where the event is going to take place. I also set up a trip to Plum Brook Station. I had to order vans and talk with the people up there to see when a good time was. I also had to make invitations and coordinate everything. I also help Sandy run the numbers in the budget. We use excel to do this, which makes it a lot easier. things. He is in the environmental safety office. I learned how to collaborate the equipment using alpha and beta sources. I went out with him and we took water samples and tested them for conductivity and chlorine. I have learned a lot in the short time I've been here. It has been a great experience and I have has the pleasure of meeting and working with great people.

  19. Cascade Distillation System Design for Safety and Mission Assurance

    Science.gov (United States)

    Sarguisingh, Miriam; Callahan, Michael R.; Okon, Shira

    2015-01-01

    Per the NASA Human Health, Life Support and Habitation System Technology Area 06 report "crewed missions venturing beyond Low-Earth Orbit (LEO) will require technologies with improved reliability, reduced mass, self-sufficiency, and minimal logistical needs as an emergency or quick-return option will not be feasible".1 To meet this need, the development team of the second generation Cascade Distillation System (CDS 2.0) chose a development approach that explicitly incorporate consideration of safety, mission assurance, and autonomy. The CDS 2.0 preliminary design focused on establishing a functional baseline that meets the CDS core capabilities and performance. The critical design phase is now focused on incorporating features through a deliberative process of establishing the systems failure modes and effects, identifying mitigation strategies, and evaluating the merit of the proposed actions through analysis and test. This paper details results of this effort on the CDS 2.0 design.

  20. Final Report of the NASA Office of Safety and Mission Assurance Agile Benchmarking Team

    Science.gov (United States)

    Wetherholt, Martha

    2016-01-01

    To ensure that the NASA Safety and Mission Assurance (SMA) community remains in a position to perform reliable Software Assurance (SA) on NASAs critical software (SW) systems with the software industry rapidly transitioning from waterfall to Agile processes, Terry Wilcutt, Chief, Safety and Mission Assurance, Office of Safety and Mission Assurance (OSMA) established the Agile Benchmarking Team (ABT). The Team's tasks were: 1. Research background literature on current Agile processes, 2. Perform benchmark activities with other organizations that are involved in software Agile processes to determine best practices, 3. Collect information on Agile-developed systems to enable improvements to the current NASA standards and processes to enhance their ability to perform reliable software assurance on NASA Agile-developed systems, 4. Suggest additional guidance and recommendations for updates to those standards and processes, as needed. The ABT's findings and recommendations for software management, engineering and software assurance are addressed herein.

  1. Quality and Safety Assurance of Iron Casts and Manufacturing Processes

    Directory of Open Access Journals (Sweden)

    Kukla S.

    2016-06-01

    Full Text Available The scope of this work focuses on the aspects of quality and safety assurance of the iron cast manufacturing processes. Special attention was given to the processes of quality control and after-machining of iron casts manufactured on automatic foundry lines. Due to low level of automation and huge work intensity at this stage of the process, a model area was established which underwent reorganization in accordance with the assumptions of the World Class Manufacturing (WCM. An analysis of work intensity was carried out and the costs were divided in order to identify operations with no value added, particularly at individual manufacturing departments. Also an analysis of ergonomics at work stations was carried out to eliminate activities that are uncomfortable and dangerous to the workers' health. Several solutions were proposed in terms of rationalization of work organization at iron cast after-machining work stations. The proposed solutions were assessed with the use of multi-criteria assessment tools and then the best variant was selected based on the assumed optimization criteria. The summary of the obtained results reflects benefits from implementation of the proposed solutions.

  2. Quality Management, Quality Assurance and Quality Control in Blood Establishments

    OpenAIRE

    Bolbate, N

    2008-01-01

    Quality terms and the roots of the matter are analyzed according to European Committee’s recommendations. Essence of process and product quality control as well as essence of quality assurance is described. Quality system’s structure including quality control, quality assurance and management is justified in the article.

  3. Health economics of blood transfusion safety

    NARCIS (Netherlands)

    Hulst, Marinus van

    2008-01-01

    The HIV/AIDS disaster in transfusion medicine shaped the future agendas for blood transfusion safety. More than ever before, the implementation of interventions which could improve blood transfusion safety was driven merely by availability of technology. The introduction of new expensive

  4. Blood transfusion safety: a new philosophy.

    Science.gov (United States)

    Franklin, I M

    2012-12-01

    Blood transfusion safety has had a chequered history, and there are current and future challenges. Internationally, there is no clear consensus for many aspects of the provision of safe blood, although pan-national legislation does provide a baseline framework in the European Union. Costs are rising, and new safety measures can appear expensive, especially when tested against some other medical interventions, such as cancer treatment and vaccination programmes. In this article, it is proposed that a comprehensive approach is taken to the issue of blood transfusion safety that considers all aspects of the process rather than considering only new measures. The need for an agreed level of safety for specified and unknown risks is also suggested. The importance of providing care and support for those inadvertently injured as a result of transfusion problems is also made. Given that the current blood safety decision process often uses a utilitarian principle for decision making--through the calculation of Quality Adjusted Life Years--an alternative philosophy is proposed. A social contract for blood safety, based on the principles of 'justice as fairness' developed by John Rawls, is recommended as a means of providing an agreed level of safety, containing costs and providing support for any adverse outcomes. © 2012 The Author. Transfusion Medicine © 2012 British Blood Transfusion Society.

  5. Management of National Nuclear Power Programs for assured safety

    Energy Technology Data Exchange (ETDEWEB)

    Connolly, T.J. (ed.)

    1985-01-01

    Topics discussed in this report include: nuclear utility organization; before the Florida Public Service Commission in re: St. Lucie Unit No. 2 cost recovery; nuclear reliability improvement and safety operations; nuclear utility management; training of nuclear facility personnel; US experience in key areas of nuclear safety; the US Nuclear Regulatory Commission - function and process; regulatory considerations of the risk of nuclear power plants; overview of the processes of reliability and risk management; management significance of risk analysis; international and domestic institutional issues for peaceful nuclear uses; the role of the Institute of Nuclear Power Operations (INPO); and nuclear safety activities of the International Atomic Energy Agency (IAEA).

  6. Unilever food safety assurance system for refined vegetable oils and fats

    Directory of Open Access Journals (Sweden)

    van Duijn Gerrit

    2010-03-01

    Full Text Available The Unilever Food Safety Assurance system for refined oils and fats is based on risk assessments for the presence of contaminants or pesticide residues in crude oils, and refining process studies to validate the removal of these components. Crude oil risk assessments were carried out by combining supply chain visits, and analyses of the contaminant and pesticide residue levels in a large number of crude oil samples. Contaminants like poly-aromatic hydrocarbons and hydrocarbons of mineral origin, and pesticide residues can largely be removed by refining. For many years, this Food Safety Assurance System has proven to be effective in controlling contaminant levels in refined vegetable oils and fats.

  7. [Haemovigilance and blood safety in overseas military].

    Science.gov (United States)

    Sailliol, A; Plang, S; Martinaud, C; Pouget, T; Vedy, S; Clavier, B; Cellarier, V; Roche, C; Civadier, C; Ausset, S

    2014-11-01

    The French military blood institute (FMBI) is the only military blood supplier in France. FMBI operates independently and autonomously under the Ministry of Defense's supervision, and accordingly, to the French, European and NATO technical and safety guidelines. FMBI is in charge of the collection, preparation and distribution of blood products to supply transfusion support to armed forces, especially during overseas operations. In overseas military, a primary physician is responsible for haemovigilance in permanent relation with an expert in the FMBI to manage any adverse reaction. Additionally, traceability of delivered or collected blood products during overseas operation represents a priority, allowing an appropriate management of transfusion inquiries and assessment of practices aiming to improve and update procedures and training. Transfusion safety in overseas operation is based on regular and specific training of people concerned by blood supply chain in exceptional situation. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  8. Assurance of reliability and safety in liquid hydrocarbons marine transportation and storing

    Science.gov (United States)

    Korshunov, G. I.; Polyakov, S. L.; Shunmin, Li

    2017-10-01

    The problems of assurance of safety and reliability in the liquid hydrocarbons marine transportation and storing are described. The requirements of standard IEC61511 have to be fulfilled for the load/unload in tanker’s system under dynamic loads on the pipeline system. The safety zones for fires of the type “fireball” and the spillage have to be determined when storing the liquid hydrocarbons. An example of the achieved necessary safety level of the duplicated load system, the conditions of the pipelines reliable operation under dynamic loads, the principles of the method of the liquid hydrocarbons storage safety zones under possible accident conditions are represented.

  9. Assuring health and safety performance on construction projects ...

    African Journals Online (AJOL)

    This article presents findings from an investigation conducted in Botswana and South Africa on how construction clients could influence health and safety (H&S) performance on construction projects. The continued poor state of construction H&S and the inability of designers and contractors to influence an industry-wide ...

  10. Feminist Heuristics: Transforming the Foundation of Food Quality and Safety Assurance Systems

    Science.gov (United States)

    Kimura, Aya Hirata

    2012-01-01

    Food safety and quality assurance systems have emerged as a key mechanism of food governance in recent years and are also popular among alternative agrofood movements, such as the organic and fair trade movements. Rural sociologists have identified many problems with existing systems, including corporate cooptation, the marginalization of small…

  11. 30 CFR 250.806 - Safety and pollution prevention equipment quality assurance requirements.

    Science.gov (United States)

    2010-07-01

    ... quality assurance requirements. 250.806 Section 250.806 Mineral Resources MINERALS MANAGEMENT SERVICE... of Safety and Pollution Prevention Equipment Used in Offshore Oil and Gas Operations; and (ii) API... specifications of API Spec 6A and 6AV1. All SSSVs must meet the technical specifications of API Specification 14A...

  12. Assuring safety without animal testing: the case for the human testis in vitro

    NARCIS (Netherlands)

    Chapin, R.E.; Boekelheide, K.; Cortvrindt, R.; Duursen, van M.; Gant, T.; Jegou, B.; Marczylo, E.; Pelt, van A.M.; Post, J.N.; Roelofs, M.J.; Schlatt, S.; Teerds, K.J.; Toppari, J.; Piersma, A.H.

    2013-01-01

    From 15 to 17 June 2011, a dedicated workshop was held on the subject of in vitro models for mammalian spermatogenesis and their applications in toxicological hazard and risk assessment. The workshop was sponsored by the Dutch ASAT initiative (Assuring Safety without Animal Testing), which aims at

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

    Science.gov (United States)

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

    2017-01-01

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

  14. Risk Classification and Risk-based Safety and Mission Assurance

    Science.gov (United States)

    Leitner, Jesse A.

    2014-01-01

    Recent activities to revamp and emphasize the need to streamline processes and activities for Class D missions across the agency have led to various interpretations of Class D, including the lumping of a variety of low-cost projects into Class D. Sometimes terms such as Class D minus are used. In this presentation, mission risk classifications will be traced to official requirements and definitions as a measure to ensure that projects and programs align with the guidance and requirements that are commensurate for their defined risk posture. As part of this, the full suite of risk classifications, formal and informal will be defined, followed by an introduction to the new GPR 8705.4 that is currently under review.GPR 8705.4 lays out guidance for the mission success activities performed at the Classes A-D for NPR 7120.5 projects as well as for projects not under NPR 7120.5. Furthermore, the trends in stepping from Class A into higher risk posture classifications will be discussed. The talk will conclude with a discussion about risk-based safety and mission assuranceat GSFC.

  15. Nanoscale sensors for assuring the safety of food products.

    Science.gov (United States)

    Wang, Yun; Duncan, Timothy V

    2017-04-01

    As far as chemical analysis is concerned, foods are among the most difficult matrices to work with because they are complex, heterogeneous substances with a high degree of variety. Assaying foods for trace levels of chemical and microbiological substances is a challenge that often requires the application of time-consuming, expensive analytical instrumentation in dedicated facilities populated by highly trained personnel. Therefore there is a continued demand for new analytical technologies that can detect small concentrations of chemicals or microbes in a more cost- and time-effective manner, preferably in the field, on the production line, and/or non-destructively, with little to no sample pre-treatment, and possibly by individuals with scant scientific training. In the last decade, nanotechnology - a branch of science that takes advantage of the unique chemical and physical properties of matter on the nanoscale - has created new opportunities for both qualitative and quantitative detection of vapors/gasses, small molecules, biopolymers, and even living microbes in a fraction of the time and expense of traditional analytical techniques. This article offers a focused review of recent progress in nanotechnology-enabled biosensing as applied to foods and related matrices, paying particular attention to trends in the field, recent breakthroughs, and current areas of need. Special focus is paid to two primary categories of nanobiosensors - optical and electrochemical - and the discussion includes a comparison of their various strengths and weaknesses as they pertain ensuring the safety of the food supply. Published by Elsevier Ltd.

  16. John F. Kennedy Space Center, Safety, Reliability, Maintainability and Quality Assurance, Survey and Audit Program

    Science.gov (United States)

    1994-01-01

    This document is the product of the KSC Survey and Audit Working Group composed of civil service and contractor Safety, Reliability, and Quality Assurance (SR&QA) personnel. The program described herein provides standardized terminology, uniformity of survey and audit operations, and emphasizes process assessments rather than a program based solely on compliance. The program establishes minimum training requirements, adopts an auditor certification methodology, and includes survey and audit metrics for the audited organizations as well as the auditing organization.

  17. Safety and Mission Assurance Knowledge Management Retention: Managing Knowledge for Successful Mission Operations

    Science.gov (United States)

    Johnson, Teresa A.

    2006-01-01

    Knowledge Management is a proactive pursuit for the future success of any large organization faced with the imminent possibility that their senior managers/engineers with gained experiences and lessons learned plan to retire in the near term. Safety and Mission Assurance (S&MA) is proactively pursuing unique mechanism to ensure knowledge learned is retained and lessons learned captured and documented. Knowledge Capture Event/Activities/Management helps to provide a gateway between future retirees and our next generation of managers/engineers. S&MA hosted two Knowledge Capture Events during 2005 featuring three of its retiring fellows (Axel Larsen, Dave Whittle and Gary Johnson). The first Knowledge Capture Event February 24, 2005 focused on two Safety and Mission Assurance Safety Panels (Space Shuttle System Safety Review Panel (SSRP); Payload Safety Review Panel (PSRP) and the latter event December 15, 2005 featured lessons learned during Apollo, Skylab, and Space Shuttle which could be applicable in the newly created Crew Exploration Vehicle (CEV)/Constellation development program. Gemini, Apollo, Skylab and the Space Shuttle promised and delivered exciting human advances in space and benefits of space in people s everyday lives on earth. Johnson Space Center's Safety & Mission Assurance team work over the last 20 years has been mostly focused on operations we are now beginning the Exploration development program. S&MA will promote an atmosphere of knowledge sharing in its formal and informal cultures and work processes, and reward the open dissemination and sharing of information; we are asking "Why embrace relearning the "lessons learned" in the past?" On the Exploration program the focus will be on Design, Development, Test, & Evaluation (DDT&E); therefore, it is critical to understand the lessons from these past programs during the DDT&E phase.

  18. Patient safety in home hemodialysis: quality assurance and serious adverse events in the home setting.

    Science.gov (United States)

    Pauly, Robert P; Eastwood, Deborah O; Marshall, Mark R

    2015-04-01

    Interest in home hemodialysis (HD) is high because of the reported benefits and its excellent safety record. However, the potential for serious adverse events (AEs) exists when patients perform HD in their homes without supervision. We review the epidemiology of dialysis-related emergencies during home HD, and present a conceptual and practical framework for the prevention and management of serious AEs for those patients performing home HD. In addition, we describe a formal monitored and iterative quality assurance program, and make suggestions for the future development of safety strategies to mitigate the risk of AEs in home HD. © 2015 International Society for Hemodialysis.

  19. Early Engagement of Safety and Mission Assurance Expertise Using Systems Engineering Tools: A Risk-Based Approach to Early Identification of Safety and Assurance Requirements

    Science.gov (United States)

    Darpel, Scott; Beckman, Sean

    2016-01-01

    Decades of systems engineering practice have demonstrated that the earlier the identification of requirements occurs, the lower the chance that costly redesigns will needed later in the project life cycle. A better understanding of all requirements can also improve the likelihood of a design's success. Significant effort has been put into developing tools and practices that facilitate requirements determination, including those that are part of the model-based systems engineering (MBSE) paradigm. These efforts have yielded improvements in requirements definition, but have thus far focused on a design's performance needs. The identification of safety & mission assurance (S&MA) related requirements, in comparison, can occur after preliminary designs are already established, yielding forced redesigns. Engaging S&MA expertise at an earlier stage, facilitated by the use of MBSE tools, and focused on actual project risk, can yield the same type of design life cycle improvements that have been realized in technical and performance requirements.

  20. Certification Strategies using Run-Time Safety Assurance for Part 23 Autopilot Systems

    Science.gov (United States)

    Hook, Loyd R.; Clark, Matthew; Sizoo, David; Skoog, Mark A.; Brady, James

    2016-01-01

    Part 23 aircraft operation, and in particular general aviation, is relatively unsafe when compared to other common forms of vehicle travel. Currently, there exists technologies that could increase safety statistics for these aircraft; however, the high burden and cost of performing the requisite safety critical certification processes for these systems limits their proliferation. For this reason, many entities, including the Federal Aviation Administration, NASA, and the US Air Force, are considering new options for certification for technologies that will improve aircraft safety. Of particular interest, are low cost autopilot systems for general aviation aircraft, as these systems have the potential to positively and significantly affect safety statistics. This paper proposes new systems and techniques, leveraging run-time verification, for the assurance of general aviation autopilot systems, which would be used to supplement the current certification process and provide a viable path for near-term low-cost implementation. In addition, discussions on preliminary experimentation and building the assurance case for a system, based on these principles, is provided.

  1. Probabilistic analysis of the safety margin assured by shear strength models of stirrup reinforced concrete beams

    Directory of Open Access Journals (Sweden)

    Jaskulski Roman

    2017-01-01

    Full Text Available The aim of this study was to assess the safety margin assured by stirrups of reinforced concrete elements subjected to shear. The safety margin was assessed by means of Monte Carlo simulation. The impact of the strength of steel and spacing of stirrups on the results was analysed as well. The used models of shear resistance were taken from the Polish standards PN-84/B-03264 and PN-EN 1992-1-1:2008. The safety margin, expressed as the logarithm of the probability of not achieving the design value of the design ultimate shear capacity was analysed as well as the impact of different assumptions on the obtained results. An attempt was made to assess the “sensitivity” of models to changes of the basic parameters of the probability distribution function of their selected variables.

  2. [Blood transfusion and supply chain management safety].

    Science.gov (United States)

    Quaranta, Jean-François; Caldani, Cyril; Cabaud, Jean-Jacques; Chavarin, Patricia; Rochette-Eribon, Sandrine

    2015-02-01

    The level of safety attained in blood transfusion now makes this a discipline better managed care activities. This was achieved both by scientific advances and policy decisions regulating and supervising the activity, as well as by the quality system, which we recall that affects the entire organizational structure, responsibilities, procedures, processes and resources in place to achieve quality management. So, an effective quality system provides a framework within which activities are established, performed in a quality-focused way and continuously monitored to improve outcomes. This system quality has to irrigate all the actors of the transfusion, just as much the establishments of blood transfusion than the health establishments. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  3. The NASA Commercial Crew Program (CCP) Shared Assurance Model for Safety

    Science.gov (United States)

    Kirkpatrick, Paul D.

    2014-01-01

    NASA established the Commercial Crew Program in order to provide human access to the International Space Station and low earth orbit via the commercial (nongovernmental) sector. A particular challenge to NASA is how to determine the commercial provider's transportation system complies with Programmatic safety requirements while at the same time allowing the provider the flexibility to demonstrate compliance. This will be accomplished through the use of Shared Assurance and Risk Based Assessment by NASA thus shifting more responsibility to the Provider. This model will be the focus of this presentation.

  4. DICOM index tracker enterprise: advanced system for enterprise-wide quality assurance and patient safety monitoring

    Science.gov (United States)

    Zhang, Min; Pavlicek, William; Panda, Anshuman; Langer, Steve G.; Morin, Richard; Fetterly, Kenneth A.; Paden, Robert; Hanson, James; Wu, Lin-Wei; Wu, Teresa

    2015-03-01

    DICOM Index Tracker (DIT) is an integrated platform to harvest rich information available from Digital Imaging and Communications in Medicine (DICOM) to improve quality assurance in radiology practices. It is designed to capture and maintain longitudinal patient-specific exam indices of interests for all diagnostic and procedural uses of imaging modalities. Thus, it effectively serves as a quality assurance and patient safety monitoring tool. The foundation of DIT is an intelligent database system which stores the information accepted and parsed via a DICOM receiver and parser. The database system enables the basic dosimetry analysis. The success of DIT implementation at Mayo Clinic Arizona calls for the DIT deployment at the enterprise level which requires significant improvements. First, for geographically distributed multi-site implementation, the first bottleneck is the communication (network) delay; the second is the scalability of the DICOM parser to handle the large volume of exams from different sites. To address this issue, DICOM receiver and parser are separated and decentralized by site. To facilitate the enterprise wide Quality Assurance (QA), a notable challenge is the great diversities of manufacturers, modalities and software versions, as the solution DIT Enterprise provides the standardization tool for device naming, protocol naming, physician naming across sites. Thirdly, advanced analytic engines are implemented online which support the proactive QA in DIT Enterprise.

  5. Seminar on safety assessment and quality assurance. Strategy and practice.; Seminarium om granskning foer saekerhet och kvalitet. Strategi och praxis

    Energy Technology Data Exchange (ETDEWEB)

    Hammar, L. [ed.] [ES-konsult AB (Sweden)

    1997-07-01

    The seminar was arranged as a part of the Nordic RAK-1 project within the Nordic reactor safety program (NKS). Improvements of safety of nuclear technology like construction, manufacturing, production of components etc. can be achieved by means of closer safety assessment at the suppliers stage and of requirements of quality assurance. Practical experience at the Finnish and Swedish reactors (Forsmark, Ringhals and others) with reactor safety and radiation protection was reported. Independent non-governmental external safety audits, for instance WANO Peer Review, have been planned. Resources for safety assurance are a critical problem, particularly in Sweden with regard to the extensive modernization program for the older nuclear power plants. Distribution of responsibility for nuclear safety between the authorities and the nuclear industry was discussed. (EG).

  6. Risk-Informed Safety Assurance and Probabilistic Assessment of Mission-Critical Software-Intensive Systems

    Science.gov (United States)

    Guarro, Sergio B.

    2010-01-01

    This report validates and documents the detailed features and practical application of the framework for software intensive digital systems risk assessment and risk-informed safety assurance presented in the NASA PRA Procedures Guide for Managers and Practitioner. This framework, called herein the "Context-based Software Risk Model" (CSRM), enables the assessment of the contribution of software and software-intensive digital systems to overall system risk, in a manner which is entirely compatible and integrated with the format of a "standard" Probabilistic Risk Assessment (PRA), as currently documented and applied for NASA missions and applications. The CSRM also provides a risk-informed path and criteria for conducting organized and systematic digital system and software testing so that, within this risk-informed paradigm, the achievement of a quantitatively defined level of safety and mission success assurance may be targeted and demonstrated. The framework is based on the concept of context-dependent software risk scenarios and on the modeling of such scenarios via the use of traditional PRA techniques - i.e., event trees and fault trees - in combination with more advanced modeling devices such as the Dynamic Flowgraph Methodology (DFM) or other dynamic logic-modeling representations. The scenarios can be synthesized and quantified in a conditional logic and probabilistic formulation. The application of the CSRM method documented in this report refers to the MiniAERCam system designed and developed by the NASA Johnson Space Center.

  7. [Safety and quality assurance management in radiation oncology "what is the role for qualiticians?": example of the Centre Alexis Vautrin].

    Science.gov (United States)

    Aigle, D; Sobczyk, C; Androni, M-L; Peiffert, D; Beckendorf, V; Marchesi, V; Buchheit, I; Noel, A

    2009-10-01

    Since 2007, the Centre Alexis-Vautrin Cancer Institute in Nancy began its safety and quality assurance management policy in the department of radiation oncology. This development induced a collaborative workflow between the quality unit and the department of radiation oncology, with a definition of the responsibilities. The quality unit provides its methodology for the quality assurance, the professionals of the radiation oncology department their expertise. In parallel, a quality referee was nominated in the radiation oncology department to implement the projects for improvement, linked with the quality assurance unit, and under the control of the radiation oncology department staff.

  8. The development and validation of dried blood spots for external quality assurance of syphilis serology

    Directory of Open Access Journals (Sweden)

    Smit Pieter W

    2013-02-01

    Full Text Available Abstract Background Syphilis causes up to 1,500,000 congenital syphilis cases annually. These could be prevented if all pregnant women were screened, and those with syphilis treated with a single dose of penicillin before 28 weeks gestation. In recent years, rapid point-of-care tests have allowed greater access to syphilis screening, especially in rural or remote areas, but the lack of quality assurance of rapid testing has been a concern. We determined the feasibility of using dried blood spots (DBS as specimens for quality assurance of syphilis serological assays. Methods We developed DBS extraction protocols for use with Treponema pallidum particle agglutination assay (TPPA, Treponema pallidum haemagglutination assay (TPHA and an enzyme immunoassay (EIA and compared the results with those using matching plasma samples from the same patient. Results Since DBS samples showed poor performance with TPHA and EIA (TPHA sensitivity was 50.5% (95% confidence interval: 39.9–61.2% and EIA specificity was 50.4% (95% CI: 43.7–57.1%, only the DBS TPPA was used in the final evaluation. DBS TPPA showed an sensitivity of 95.5% (95% CI: 91.3–98.0% and a specificity of 99.0% (95% CI: 98.1–99.5% compared to TPPA using plasma samples as a reference. Conclusion DBS samples can be recommended for use with TPPA, and may be of value for external quality assurance of point-of-care syphilis testing.

  9. Approaches to advancing blood safety through haemovigilance: A ...

    African Journals Online (AJOL)

    Background: Blood transfusion is always associated with some level of risk. Haemovigilance is a risk monitoring system integral to the practice of transfusion medicine whose ultimate purpose is to improve the quality and safety of transfusion therapy. Objective: To examine the contribution of haemovigilance to blood safety, ...

  10. Radiological safety status and quality assurance audit of medical X-ray diagnostic installations in India

    Directory of Open Access Journals (Sweden)

    Sonawane A

    2010-01-01

    Full Text Available We conducted a radiological safety and quality assurance (QA audit of 118 medical X-ray diagnostic machines installed in 45 major hospitals in India. The main objective of the audit was to verify compliance with the regulatory requirements stipulated by the national regulatory body. The audit mainly covered accuracy check of accelerating potential (kVp, linearity of tube current (mA station and timer, congruence of radiation and optical field, and total filtration; in addition, we also reviewed medical X-ray diagnostic installations with reference to room layout of X-ray machines and conduct of radiological protection survey. A QA kit consisting of a kVp Test-O-Meter (ToM (Model RAD/FLU-9001, dose Test-O-Meter (ToM (Model 6001, ionization chamber-based radiation survey meter model Gun Monitor and other standard accessories were used for the required measurements. The important areas where there was noncompliance with the national safety code were: inaccuracy of kVp calibration (23%, lack of congruence of radiation and optical field (23%, nonlinearity of mA station (16% and timer (9%, improper collimator/diaphragm (19.6%, faulty adjustor knob for alignment of field size (4%, nonavailability of warning light (red light at the entrance of the X-ray room (29%, and use of mobile protective barriers without lead glass viewing window (14%. The present study on the radiological safety status of diagnostic X-ray installations may be a reasonably good representation of the situation in the country as a whole. The study contributes significantly to the improvement of radiological safety by the way of the steps already taken and by providing a vital feed back to the national regulatory body.

  11. Assuring safety without animal testing concept (ASAT). Integration of human disease data with in vitro data to improve toxicology testing

    NARCIS (Netherlands)

    Stierum, Rob; Aarts, Jac; Boorsma, Andre; Bosgra, Sieto; Caiment, Florian; Ezendam, Janine; Greupink, Rick; Hendriksen, Peter; Soeteman-Hernandez, Lya G.; Jennen, Danyel; Kleinjans, Jos; Kroese, Dinant; Kuper, Frieke; van Loveren, Henk; Monshouwer, Mario; Russel, Frans; van Someren, Eugene; Tsamou, Maria; Groothuis, Geny

    2014-01-01

    According to the Assuring Safety Without Animal Testing (ASAT) principle, risk assessment may ultimately become possible without the use of animals (Fentem et al., (2004). Altern. Lab. Anim. 32, 617-623). The ASAT concept takes human disease mechanisms as starting point and tries to define if

  12. Safety and Mission Assurance for In-House Design Lessons Learned from Ares I Upper Stage

    Science.gov (United States)

    Anderson, Joel M.

    2011-01-01

    This viewgraph presentation identifies lessons learned in the course of the Ares I Upper Stage design and in-house development effort. The contents include: 1) Constellation Organization; 2) Upper Stage Organization; 3) Presentation Structure; 4) Lesson-Importance of Systems Engineering/Integration; 5) Lesson-Importance of Early S&MA Involvement; 6) Lesson-Importance of Appropriate Staffing Levels; 7) Lesson-Importance S&MA Team Deployment; 8) Lesson-Understanding of S&MA In-Line Engineering versus Assurance; 9) Lesson-Importance of Close Coordination between Supportability and Reliability/Maintainability; 10) Lesson-Importance of Engineering Data Systems; 11) Lesson-Importance of Early Development of Supporting Databases; 12) Lesson-Importance of Coordination with Safety Assessment/Review Panels; 13) Lesson-Implementation of Software Reliability; 14) Lesson-Implementation of S&MA Technical Authority/Chief S&MA Officer; 15) Lesson-Importance of S&MA Evaluation of Project Risks; 16) Lesson-Implementation of Critical Items List and Government Mandatory Inspections; 17) Lesson-Implementation of Critical Items List Mandatory Inspections; 18) Lesson-Implementation of Test Article Safety Analysis; and 19) Lesson-Importance of Procurement Quality.

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

    Science.gov (United States)

    Withrow, Colleen A.; Reveley, Mary S.

    2015-01-01

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

  14. Pacific Northwest Laboratory annual report for 1988 to the Assistant Secretary for Environment, Safety, and Health: Part 5, Environment, safety, health, and quality assurance

    Energy Technology Data Exchange (ETDEWEB)

    Faust, L.G.; Pennell, W.T.; Selby, J.M.

    1989-02-01

    This document summarizes the research programs now underway at Battelle's Pacific Northwest Laboratory in the areas of environmental safety, health, and quality assurance. Topics include internal irradiation, emergency plans, dose equivalents, risk assessment, dose equivalents, surveys, neutron dosimetry, and radiation accidents. (TEM)

  15. PREVENTIVE MEASURES FOR THE IMPROVEMENT OF THE SAFETY OF BLOOD TRANSFUSION AND VIRTUAL TRANSFUSION LABORATORY

    Directory of Open Access Journals (Sweden)

    Primož Rožman

    2002-04-01

    Full Text Available Background. Even though blood transfusion is a relatively safe form of therapy, because of the eventual administrative errors in the transfusion chain between the blood donor and the recipient of blood, transfusion errors still occur. Therefore, it is imperative to ensure an utmost extent of safety and reliability of all transfusion related procedures. The safety of blood transfusion can be improved by preventive actions, i.e. implementation of the total quality management concept, haemovigilance and virtual transfusion laboratory. In the resulting system, the information web, robotics, computer sciences and communication technologies ensure safe and reliable identification of the patients, blood donors, corresponding test samples and blood products. Apart form this; the modern technologies enable the automation of laboratory testing, the integrity of laboratory results and enable an optimal use of blood.Conclusions. For an improved transfusion safety in Slovenia, adoption of corresponding prevention as well as haemovigilance is necessary. Identification errors can be prevented by implementation of the wristbands systems with the code bars for the tagging of the patient and his biological samples, whereas the administrative errors in the blood bank and transfusion laboratory can be prevented by implementation of information systems and automation.We assume that the virtual transfusion laboratory will become an integral part of the new Slovenian transfusion web and will speed up, unify and simplify today’s methods of ordering and administering blood products. To the attending physician, it will enable the choice of optimal transfusion therapy schedule and at the same time, it will enable the supervision of individual orders, deviations and indications, all of which is needed in order to analyse and improve the quality and the costs of the treatment. These services represent the first obligatory step for the modernisation of the transfusion

  16. Probability of loss of assured safety in systems with multiple time-dependent failure modes.

    Energy Technology Data Exchange (ETDEWEB)

    Helton, Jon Craig; Pilch, Martin.; Sallaberry, Cedric Jean-Marie.

    2012-09-01

    Weak link (WL)/strong link (SL) systems are important parts of the overall operational design of high-consequence systems. In such designs, the SL system is very robust and is intended to permit operation of the entire system under, and only under, intended conditions. In contrast, the WL system is intended to fail in a predictable and irreversible manner under accident conditions and render the entire system inoperable before an accidental operation of the SL system. The likelihood that the WL system will fail to deactivate the entire system before the SL system fails (i.e., degrades into a configuration that could allow an accidental operation of the entire system) is referred to as probability of loss of assured safety (PLOAS). Representations for PLOAS for situations in which both link physical properties and link failure properties are time-dependent are derived and numerically evaluated for a variety of WL/SL configurations, including PLOAS defined by (i) failure of all SLs before failure of any WL, (ii) failure of any SL before failure of any WL, (iii) failure of all SLs before failure of all WLs, and (iv) failure of any SL before failure of all WLs. The effects of aleatory uncertainty and epistemic uncertainty in the definition and numerical evaluation of PLOAS are considered.

  17. Assuring safety without animal testing: the case for the human testis in vitro.

    Science.gov (United States)

    Chapin, Robert E; Boekelheide, Kim; Cortvrindt, Rita; van Duursen, Majorie B M; Gant, Tim; Jegou, Bernard; Marczylo, Emma; van Pelt, Ans M M; Post, Janine N; Roelofs, Maarke J E; Schlatt, Stefan; Teerds, Katja J; Toppari, Jorma; Piersma, Aldert H

    2013-08-01

    From 15 to 17 June 2011, a dedicated workshop was held on the subject of in vitro models for mammalian spermatogenesis and their applications in toxicological hazard and risk assessment. The workshop was sponsored by the Dutch ASAT initiative (Assuring Safety without Animal Testing), which aims at promoting innovative approaches toward toxicological hazard and risk assessment on the basis of human and in vitro data, and replacement of animal studies. Participants addressed the state of the art regarding human and animal evidence for compound mediated testicular toxicity, reviewed existing alternative assay models, and brainstormed about future approaches, specifically considering tissue engineering. The workshop recognized the specific complexity of testicular function exemplified by dedicated cell types with distinct functionalities, as well as different cell compartments in terms of microenvironment and extracellular matrix components. This complexity hampers quick results in the realm of alternative models. Nevertheless, progress has been achieved in recent years, and innovative approaches in tissue engineering may open new avenues for mimicking testicular function in vitro. Although feasible, significant investment is deemed essential to be able to bring new ideas into practice in the laboratory. For the advancement of in vitro testicular toxicity testing, one of the most sensitive end points in regulatory reproductive toxicity testing, such an investment is highly desirable. Copyright © 2013. Published by Elsevier Inc. All rights reserved.

  18. Radiation safety and quality control assurance in X-ray diagnostics 1998; Saeteilyturvallisuus ja laadunvarmistus roentgendiagnostiikassa 1998

    Energy Technology Data Exchange (ETDEWEB)

    Servomaa, A. [ed.

    1998-03-01

    The report is based on a seminar course of lectures `Radiation safety and quality assurance in X-ray diagnostics 1998` organized by the Radiation and Nuclear Safety Authority (STUK) in Finland. The lectures included actual information on X-ray examinations: methods of quality assurance, methods of measuring and calculating patient doses, examination frequencies, patient doses, occupational doses, and radiation risks. Paediatric X-ray examinations and interventional procedures were the most specific topics. The new Council Directive 97/43/Euratom on medical exposure, and the European Guidelines on quality criteria for diagnostic radiographic images, were discussed in several lectures. Lectures on general radiation threats and preparedness, examples of radiation accidents, and emergency preparedness in hospitals were also included. (editor)

  19. Blood transfusion safety; current status and challenges in Nigeria

    Science.gov (United States)

    Aneke, John C.; Okocha, Chide E.

    2017-01-01

    The attainment of blood transfusion safety in Nigeria (and probably the rest of Sub-Saharan Africa) remains an uphill task due to a number of factors, ranging from shortage of blood, poor implementation of blood transfusion guidelines, infrastructural deficits to high prevalence of transfusion-transmissible infections (TTIs), particularly hepatitis and human immune deficiency viruses. We reviewed available data on blood transfusion practices and safety in Nigeria using the PubMed, PubMed Central, Google Scholar, and African Index Medicus search engines, through a combination of word and phrases relevant to the subject. The World Health Organization has been in the forefront of efforts to establish safe, available, and affordable blood transfusion services in most parts of Africa through encouraging adequate blood donor recruitment, donor blood testing, and collection as well developing strategies for the rational use of blood. Even though modest improvement has been recorded, particularly with regards to donor blood screening for common TTIs, considerable efforts are needed in the form of robust public enlightenment campaigns (on blood donation) and continuous system improvement to drive the current transfusion practices in the country toward safety and self-sustenance. PMID:28316432

  20. Approaches to advancing blood safety through haemovigilance: A ...

    African Journals Online (AJOL)

    Approaches to advancing blood safety through haemovigilance: A review. ... Abstract. Background: Blood transfusion is always associated with some level of risk. Haemovigilance ... Data sources: The internet and journals on the topic of haemovigilance and development of haemovigilance systems in the English language.

  1. Application of quality assurance human factors and reliability principles to the prevention of major environment, safety, and health incidents

    Energy Technology Data Exchange (ETDEWEB)

    Trauth, C.A. Jr.; Ellingson, A.C.; Farr, D.E.; Jercinovic, L.M.

    1978-12-01

    The study described in this report is part of a program to investigate how proven principles and techniques from the disciplines of quality assurance, reliability, and human factors might be used, or modified, to support environment, health, and safety programs. This report describes a study undertaken to determine whether there appears to be genuine, potential benefit from the use or modification of such principles or techniques in accident prevention. Results are based on a hindsight analysis of major accidents which have occurred.

  2. [Blood transfusion - safety of the inventory].

    Science.gov (United States)

    Tissot, Jean-Daniel; Danic, Bruno; Schneider, Thierry

    2015-02-01

    Over the years, transfusion medicine has been faced to many different problems, notably those related to transmission of pathogens. Major progresses have been accomplished in terms of security. However, nowadays, the discipline is confronted to the day-to-day variability and availability of blood products. More and more donors are excluded from blood donation due to various reasons, and the donor selection criteria have increased over the years, influencing the number of donors able to give blood. This paradox represents one of the constraints that transfusion medicine should resolve in the future. This paper presents some aspects either common or different between France and Switzerland. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  3. Blood safety and availability: continuing challenges in China's blood banking system.

    Science.gov (United States)

    Shi, Ling; Wang, Jing-Xing; Stevens, Lori; Ness, Paul; Shan, Hua

    2014-02-01

    Social and economic development, along with increased health care coverage, has caused a sharp increase in the clinical demand for blood in China. Whole blood collection has increased rapidly in the past decade but has failed to keep pace with the ever-increasing demand. Overall, the country's blood safety has been improved with 99% of whole blood donations collected from voluntary unpaid donors. However, the unmet clinical demand for blood and the increasing incidence of human immunodeficiency virus and syphilis in the general population pose new challenges to China's blood banking system. To ensure a safe and adequate blood supply, continued efforts are required to recruit and retain a sufficient number of low-risk voluntary blood donors, improve donor prescreening and blood testing process, ease donor restrictions, and strengthen patient blood management. © 2013 American Association of Blood Banks.

  4. Approaches to advancing blood safety through haemovigilance: a review.

    Science.gov (United States)

    Mwangi, J W; Kimani, D; Oduor, M

    2009-12-01

    Blood transfusion is always associated with some level of risk. Haemovigilance is a risk monitoring system integral to the practice of transfusion medicine whose ultimate purpose is to improve the quality and safety of transfusion therapy. To examine the contribution of haemovigilance to blood safety, including the approaches that some countries have taken to institute haemovigilance, and explore routes through which countries without such systems can achieve them. The internet and journals on the topic of haemovigilance and development of haemovigilance systems in the English language. Reputable journals on the topic of haemovigilance were examined for abstracts and papers. Abstracts based on known credible and distinguished sources were selected. Information on haemovigilance and the processes of developing haemovigilance in various countries was reviewed. The information from selected papers and abstracts was used for writing this paper. Varying processes for haemovigilance have been adopted by different countries. The more advanced systems have national/regional coordinating mechanisms. Availability of haemovigilance data has given transfusion services a clear understanding of problems associated with transfusion that need to be solved so as to improve transfusion safety. Although countries in sub-Saharan Africa have made considerable progress in enhancing blood safety in the recent past, nationally coordinated haemovigilance systems are lacking. Focus on haemovigilance systems is considered the next frontier to be conquered in enhancing blood safety in the region.

  5. Can a decentralized blood system ensure self-sufficiency and blood safety? The Lebanese experience.

    Science.gov (United States)

    Haddad, Antoine; Bou Assi, Tarek; Garraud, Olivier

    2017-08-01

    Lebanon has adopted a liberal economic system that also applies to healthcare procurement. There is no national Lebanese blood transfusion service and the blood supply is divided between a large number of licensed (45 per cent) and unlicensed (55 per cent) blood banks, many of them issuing a very limited number of blood components. All blood banks are hospital based and operate the entire transfusion chain, from collection to the release of blood units. Blood donation is voluntary and non-remunerated in 20-25 per cent of donations; it relies principally on replacement donations. Recently, Lebanon has faced political instability and war, and now welcomes an enormous number of refugees from neighboring countries at war. This has had an important impact on heath care and on the transfusion supply. We discuss the impact of the blood donation organization on the transfusion safety and ethics, to set the foundation for a more developed and safer transfusion programs.

  6. Surgical innovation-enhanced quality and the processes that assure patient/provider safety: A surgical conundrum.

    Science.gov (United States)

    Bruny, Jennifer; Ziegler, Moritz

    2015-12-01

    Innovation is a crucial part of surgical history that has led to enhancements in the quality of surgical care. This comprises both changes which are incremental and those which are frankly disruptive in nature. There are situations where innovation is absolutely required in order to achieve quality improvement or process improvement. Alternatively, there are innovations that do not necessarily arise from some need, but simply are a new idea that might be better. All change must assure a significant commitment to patient safety and beneficence. Innovation would ideally enhance patient care quality and disease outcomes, as well stimulate and facilitate further innovation. The tensions between innovative advancement and patient safety, risk and reward, and demonstrated effectiveness versus speculative added value have created a contemporary "surgical conundrum" that must be resolved by a delicate balance assuring optimal patient/provider outcomes. This article will explore this delicate balance and the rules that govern it. Recommendations are made to facilitate surgical innovation through clinical research. In addition, we propose options that investigators and institutions may use to address competing priorities. Copyright © 2015 Elsevier Inc. All rights reserved.

  7. Review: The procurement, storage and quality assurance of frozen blood and tissue biospecimens

    Directory of Open Access Journals (Sweden)

    Manoj S. Charde

    2014-05-01

    Full Text Available The preserved frozen biospecimens are ideal for evaluating the genome, transcriptome, and proteome. Here we present a current overview of experimental data regarding procurement, storage, and quality assurance that can informthe handling of frozen biospecimens. Degradation of frozen biospecimens can be affected by collecting methodology, premortem agonal changes and warm ischemic time during surgery.  Tissue storage at− 80 °C can preserve DNA and protein but RNA show degradation at 5 years, therefore storage at − 150 °C provides significant advantages.  Histologic quality assurance of tissue biospecimens is typically performed at the time of surgery but should also be conducted on the aliquot to be distributed because of tissue heterogeneity.Additional qualityassurance testing should be dictated by the anticipated downstream applications.

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

    Science.gov (United States)

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

    2013-09-01

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

  9. Improving blood safety: Errors management in transfusion medicine

    Directory of Open Access Journals (Sweden)

    Bujandrić Nevenka

    2014-01-01

    Full Text Available Introduction. The concept of blood safety includes the entire transfusion chain starting with the collection of blood from the blood donor, and ending with blood transfusion to the patient. The concept involves quality management system as the systematic monitoring of adverse reactions and incidents regarding the blood donor or patient. Monitoring of near-miss errors show the critical points in the working process and increase transfusion safety. Objective. The aim of the study was to present the analysis results of adverse and unexpected events in transfusion practice with a potential risk to the health of blood donors and patients. Methods. One-year retrospective study was based on the collection, analysis and interpretation of written reports on medical errors in the Blood Transfusion Institute of Vojvodina. Results. Errors were distributed according to the type, frequency and part of the working process where they occurred. Possible causes and corrective actions were described for each error. The study showed that there were not errors with potential health consequences for the blood donor/patient. Errors with potentially damaging consequences for patients were detected throughout the entire transfusion chain. Most of the errors were identified in the preanalytical phase. The human factor was responsible for the largest number of errors. Conclusion. Error reporting system has an important role in the error management and the reduction of transfusion-related risk of adverse events and incidents. The ongoing analysis reveals the strengths and weaknesses of the entire process and indicates the necessary changes. Errors in transfusion medicine can be avoided in a large percentage and prevention is costeffective, systematic and applicable.

  10. Medical devices, electronic health records and assuring patient safety : Future challenges?

    NARCIS (Netherlands)

    Kalkman, Cor J.|info:eu-repo/dai/nl/078251818

    2015-01-01

    The patient safety movement was triggered by publications showing that modern health care is more unsafe than road travel and that more patients are killed annually by avoidable adverse events than by breast cancer [1]. As a result, an urgent need to improve patient safety has dominated

  11. Systematic assessment of core assurance activities in a company specific food safety management system

    NARCIS (Netherlands)

    Luning, P.A.; Marcelis, W.J.; Rovira, J.; Spiegel, van der M.; Uyttendaele, M.; Jacxsens, L.

    2009-01-01

    The dynamic environment wherein agri-food companies operate and the high requirements on food safety force companies to critically judge and improve their food safety management system (FSMS) and its performance. The objective of this study was to develop a diagnostic instrument enabling a

  12. Exposing exposure: enhancing patient safety through automated data mining of nuclear medicine reports for quality assurance and organ dose monitoring.

    Science.gov (United States)

    Ikuta, Ichiro; Sodickson, Aaron; Wasser, Elliot J; Warden, Graham I; Gerbaudo, Victor H; Khorasani, Ramin

    2012-08-01

    To develop and validate an open-source informatics toolkit capable of creating a radiation exposure data repository from existing nuclear medicine report archives and to demonstrate potential applications of such data for quality assurance and longitudinal patient-specific radiation dose monitoring. This study was institutional review board approved and HIPAA compliant. Informed consent was waived. An open-source toolkit designed to automate the extraction of data on radiopharmaceuticals and administered activities from nuclear medicine reports was developed. After iterative code training, manual validation was performed on 2359 nuclear medicine reports randomly selected from September 17, 1985, to February 28, 2011. Recall (sensitivity) and precision (positive predictive value) were calculated with 95% binomial confidence intervals. From the resultant institutional data repository, examples of usage in quality assurance efforts and patient-specific longitudinal radiation dose monitoring obtained by calculating organ doses from the administered activity and radiopharmaceutical of each examination were provided. Validation statistics yielded a combined recall of 97.6% ± 0.7 (95% confidence interval) and precision of 98.7% ± 0.5. Histograms of administered activity for fluorine 18 fluorodeoxyglucose and iodine 131 sodium iodide were generated. An organ dose heatmap which displays a sample patient's dose accumulation from multiple nuclear medicine examinations was created. Large-scale repositories of radiation exposure data can be extracted from institutional nuclear medicine report archives with high recall and precision. Such repositories enable new approaches in radiation exposure patient safety initiatives and patient-specific radiation dose monitoring.

  13. The safety assurance method of railway control systems using object oriented languages

    Science.gov (United States)

    Sumiła, Marek; Lewiński, Andrzej

    2010-01-01

    The paper deals with introduction of safety rules to the software designed for railway control systems. The basic assumption is related to software designed using high level language UML with possibility of modelling, verification, functional testing and simulation in CASE environment. The object methodology - the base of UML regards the software implementation with respect to safety and real time control corresponding to UIC recommendations and CENELEC standards.

  14. Quantifying radiation safety and quality in medical imaging, part 3: the quality assurance scorecard.

    Science.gov (United States)

    Reiner, Bruce I

    2009-10-01

    The practice of medical imaging is fraught with inconsistency as it relates to quality assurance, which is due in part to the lack of standardization and objective quality-centric data. By applying the scientific methods of Shewhart and Deming to medical imaging quality assessment, one can devise an objective, data-driven quality model, encompassing the various steps and processes that take place within the medical imaging chain. Through automated recording, tracking, and analysis of these quality data elements, a quantitative scorecard can be derived that provides an objective measure of quality performance, relating to each individual process, participating stakeholder, and technology being used. Through meta-analysis of these quality-centric data, best practice guidelines can be created, which in turn promote quality as the major differentiating feature of service providers.

  15. TU-A-304-03: Quality Assurance, Safety, and Other Practical Aspects of SBRT

    Energy Technology Data Exchange (ETDEWEB)

    Benedict, S. [UC Davis Cancer Center (United States)

    2015-06-15

    Increased use of SBRT and hypo fractionation in radiation oncology practice has posted a number of challenges to medical physicist, ranging from planning, image-guided patient setup and on-treatment monitoring, to quality assurance (QA) and dose delivery. This symposium is designed to provide updated knowledge necessary for the safe and efficient implementation of SBRT in various linac platforms, including the emerging digital linacs equipped with high dose rate FFF beams. Issues related to 4D CT, PET and MRI simulations, 3D/4D CBCT guided patient setup, real-time image guidance during SBRT dose delivery using gated/un-gated VMAT or IMRT, and technical advancements in QA of SBRT (in particular, strategies dealing with high dose rate FFF beams) will be addressed. The symposium will help the attendees to gain a comprehensive understanding of the SBRT workflow and facilitate their clinical implementation of the state-of-art imaging and planning techniques. Learning Objectives: Present background knowledge of SBRT, describe essential requirements for safe implementation of SBRT, and discuss issues specific to SBRT treatment planning and QA. Update on the use of multi-dimensional (3D and 4D) and multi-modality (CT, beam-level X-ray imaging, pre- and on-treatment 3D/4D MRI, PET, robotic ultrasound, etc.) for reliable guidance of SBRT. Provide a comprehensive overview of emerging digital linacs and summarize the key geometric and dosimetric features of the new generation of linacs for substantially improved SBRT. Discuss treatment planning and quality assurance issues specific to SBRT. Research grant from Varian Medical Systems.

  16. Mucocutaneous blood contact: blood release behavior of safety peripheral intravenous catheters.

    Science.gov (United States)

    Wittmann, Andreas; Köver, Jan; Kralj, Nenad; Gasthaus, Klaus; Tosch, Marco; Hofmann, Friedrich

    2013-12-01

    Protection against needlestick injuries has significantly improved in recent years thanks to so-called "safety devices." However, a potential drawback occasionally reported by users is a risk of blood splashing. If this blood comes in contact with the mucous membranes, it could lead to an infection. Five safety peripheral intravenous catheter brands were examined in a laboratory test. To simulate the extreme situations, which may arise through human use, the introducer needle was withdrawn from the catheter at 2 different angles whereby an industrial robot was used to simulate the sequence of this movement. Each brand was tested 30 times. The experiment was carried out using radioactively labeled human whole blood. The measurements for the transmitted volume of blood was taken both from an artificial head and from a surface measuring 18.5 cm by 26.5 cm at a height of 30 cm above the catheter; scintigraphy was used to take the measurements. The volume of blood droplets potentially splashing into the mucous membranes was in the range of 1 nL. For normal virus concentrations in the blood of sick patients, this dose is too small to cause hepatitis C and HIV. Copyright © 2013 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

  17. The infectious disease blood safety risk of Australian hemochromatosis donations.

    Science.gov (United States)

    Hoad, Veronica; Bentley, Peter; Bell, Barbara; Pathak, Praveen; Chan, Hiu Tat; Keller, Anthony

    2016-12-01

    It has been suggested that blood donors with hereditary hemochromatosis may pose an increased infectious disease risk and adversely affect recipient outcomes. This study compares the infectious disease risk of whole blood (WB) donors enrolled as therapeutic (T) donors to voluntary WB donors to evaluate the safety of blood products provided by the T donors. This was a retrospective cohort study of all WB donations at the Australian Red Cross Blood Service who donated between January 1, 2011, and December 31, 2013, comparing a yearly mean of 11,789 T donors with 107,773 total donations and a yearly mean of 468,889 voluntary WB donors with 2,584,705 total donations. We compared postdonation notification of infectious illnesses, bacterial contamination screening results, and positive tests for blood borne viruses in T and WB donors. Rates of transfusion-transmissible infections in donations destined for component manufacture were significantly lower in therapeutic donations compared to voluntary donations (8.4 vs. 21.6 per 100,000 donations). Bacterial contamination (43.0 vs. 45.9 per 100,000 donations) and postdonation illness reporting (136.2 vs. 110.8 per 100,000 donations) were similar in both cohorts. The Australian therapeutic venisection program enables T donors to provide a safe and acceptable source of donated WB that has a low infectious disease risk profile. © 2016 AABB.

  18. SAFETY CONSIDERATIONS WITH BLOOD FLOW RESTRICTED RESISTANCE TRAINING

    Directory of Open Access Journals (Sweden)

    Alan Kacin

    2015-11-01

    Full Text Available Blood flow restricted resistance (BFRR training with pneumatic tourniquet has been suggested as an alternative for conventional weight training due to the proven benefits for muscle strength and hypertrophy using relatively low resistance, hence reducing the mechanical stress across a joint. As such, it has become an important part of rehabilitation programs used in either injured or operated athletes. Despite a general consensus on effectiveness of BFRR training for muscle conditioning, there are several uncertainties regarding the interplay of various extrinsic and intrinsic factors on its safety and efficiency, which are being reviewed from a clinical perspective. Among extrinsic factors tourniquet cuff pressure, size and shape have been identified as key for safety and efficiency. Among intrinsic factors, limb anthropometrics, patient history and presence of cardiac, vascular, metabolic or peripheral neurologic conditions have been recognized as most important. Though there are a few potential safety concerns connected to BFRR training, the following have been identified as the most probable and health-hazardous: (a mechanical injury to the skin, muscle, and peripheral nerves, (b venous thrombosis due to vascular damage and disturbed hemodynamics and (c augmented arterial blood pressure responses due to combined high body exertion and increased peripheral vascular resistance. Based on reviewed literature and authors’ personal experience with the use of BFRR training in injured athletes, some guidelines for its safe application are outlined. Also, a comprehensive risk assessment tool for screening of subjects prior to their inclusion in a BFRR training program is being introduced.

  19. Safety assurance of cosmetics in Japan: current situation and future prospects.

    Science.gov (United States)

    Inomata, Shinji

    2014-01-01

    The Japanese Pharmaceutical Affairs Law distinguishes cosmetics from quasi-drugs, and specifies that they must have a mild effect on the human body and must be safe to use over the long term. Therefore, the safety of cosmetics needs to be thoroughly evaluated and confirmed, taking into account the type of cosmetic, application method, conditions of use and so on. Post-marketing surveys of customers' complaints and case reports of adverse effects are important to monitor and confirm the safety of products. Although manufacturing and marketing of cosmetics are becoming more globalized, the regulations relevant to cosmetics safety still vary from country to country. Thus, compliance with different regulations in various markets is a major issue for producers. In particular, further development of alternatives to animal testing remains an urgent global issue.

  20. 49 CFR Appendix C to Part 236 - Safety Assurance Criteria and Processes

    Science.gov (United States)

    2010-10-01

    ..., Part 17, 21, and 23. (vi) Safety of High-Speed Ground Transportation Systems. Analytical Methodology... INSTALLATION, INSPECTION, MAINTENANCE, AND REPAIR OF SIGNAL AND TRAIN CONTROL SYSTEMS, DEVICES, AND APPLIANCES... application to processor-based signal and train control systems are recognized as acceptable with respect to...

  1. Food safety assurance systems: Microbiological testing, sampling plans, and microbiological criteria

    NARCIS (Netherlands)

    Zwietering, M.H.; Ross, T.; Gorris, L.G.M.

    2014-01-01

    Microbiological criteria give information about the quality or safety of foods. A key component of a microbiological criterion is the sampling plan. Considering: (1) the generally low level of pathogens that are deemed tolerable in foods, (2) large batch sizes, and (3) potentially substantial

  2. Pathogen Inactivation Technologies: The Advent of Pathogen-Reduced Blood Components to Reduce Blood Safety Risk.

    Science.gov (United States)

    Devine, Dana V; Schubert, Peter

    2016-06-01

    Pathogen inactivation technologies represent a shift in blood safety from a reactive approach to a proactive protective strategy. Commercially available technologies demonstrate effective killing of most viruses, bacteria, and parasites and are capable of inactivating passenger leukocytes in blood products. The use of pathogen inactivation causes a decrease in the parameters of products that can be readily measured in laboratory assays but that do not seem to cause any alteration in hemostatic effect of plasma or platelet transfusions. Effort needs to be made to further develop these technologies so that the negative quality impact is ameliorated without reducing the pathogen inactivation effectiveness. Copyright © 2016 Elsevier Inc. All rights reserved.

  3. Assuring consumer safety without animal testing: a feasibility case study for skin sensitisation.

    Science.gov (United States)

    Maxwell, Gavin; Aleksic, Maja; Aptula, Aynur; Carmichael, Paul; Fentem, Julia; Gilmour, Nicola; Mackay, Cameron; Pease, Camilla; Pendlington, Ruth; Reynolds, Fiona; Scott, Daniel; Warner, Guy; Westmoreland, Carl

    2008-11-01

    Allergic Contact Dermatitis (ACD; chemical-induced skin sensitisation) represents a key consumer safety endpoint for the cosmetics industry. At present, animal tests (predominantly the mouse Local Lymph Node Assay) are used to generate skin sensitisation hazard data for use in consumer safety risk assessments. An animal testing ban on chemicals to be used in cosmetics will come into effect in the European Union (EU) from March 2009. This animal testing ban is also linked to an EU marketing ban on products containing any ingredients that have been subsequently tested in animals, from March 2009 or March 2013, depending on the toxicological endpoint of concern. Consequently, the testing of cosmetic ingredients in animals for their potential to induce skin sensitisation will be subject to an EU marketing ban, from March 2013 onwards. Our conceptual framework and strategy to deliver a non-animal approach to consumer safety risk assessment can be summarised as an evaluation of new technologies (e.g. 'omics', informatics), leading to the development of new non-animal (in silico and in vitro) predictive models for the generation and interpretation of new forms of hazard characterisation data, followed by the development of new risk assessment approaches to integrate these new forms of data and information in the context of human exposure. Following the principles of the conceptual framework, we have been investigating existing and developing new technologies, models and approaches, in order to explore the feasibility of delivering consumer safety risk assessment decisions in the absence of new animal data. We present here our progress in implementing this conceptual framework, with the skin sensitisation endpoint used as a case study. 2008 FRAME.

  4. FOOD QUALITY AND SAFETY ASSURANCE IN TERMS OF LOSS AND WASTE LIMITATION

    Directory of Open Access Journals (Sweden)

    Maria Śmiechowska

    2016-06-01

    Full Text Available One of the greatest challenges of 21st century is satisfying the food needs of the fast growing population of the world. Food must fulfill quality and safety standards.  The access to safe and appropriate food is not the same everywhere.  Food excess and, in consequence, food waste is present in many regions of the world. This study is meant to explain the causes of food waste on the basis of the author’s own research and study results of other scientists. The lack of authenticity and falsification belong to the new factors endangering food safety and food waste related thereto. This analysis proves that the authenticity of food improves its safety through the implementation of quality management systems, the appropriate system of food labelling and food identification by means of applicable law regulations, supervision and control systems. Main aim of this study is to address why, even though there are so many quality standards and systems, a significant problem with food loss and waste constantly occurs. Waste-causing factors have been determined on the example of bread and the handling of unconsumed bread has been attempted in this study. Waste limiting actions are necessary as food production is significantly overburdening the natural environment and generating increasing amount of waste, hazardous to the clean air. 

  5. Assuring the safety of genetically modified (GM) foods: the importance of an holistic, integrative approach.

    Science.gov (United States)

    Cockburn, Andrew

    2002-09-11

    Genes change continuously by natural mutation and recombination enabling man to select and breed crops having the most desirable traits such as yield or flavour. Genetic modification (GM) is a recent development which allows specific genes to be identified, isolated, copied and inserted into other plants with a high level of specificity. The food safety considerations for GM crops are basically the same as those arising from conventionally bred crops, very few of which have been subject to any testing yet are generally regarded as being safe to eat. In contrast a rigorous safety testing paradigm has been developed for GM crops, which utilises a systematic, stepwise and holistic approach. The resultant science based process, focuses on a classical evaluation of the toxic potential of the introduced novel trait and the wholesomeness of the transformed crop. In addition, detailed consideration is given to the history and safe use of the parent crop as well as that of the gene donor. The overall safety evaluation is conducted under the concept known as substantial equivalence which is enshrined in all international crop biotechnology guidelines. This provides the framework for a comparative approach to identify the similarities and differences between the GM product and its comparator which has a known history of safe use. By building a detailed profile on each step in the transformation process, from parent to new crop, and by thoroughly evaluating the significance from a safety perspective, of any differences that may be detected, a very comprehensive matrix of information is constructed which enables the conclusion as to whether the GM crop, derived food or feed is as safe as its traditional counterpart. Using this approach in the evaluation of more than 50 GM crops which have been approved worldwide, the conclusion has been that foods and feeds derived from genetically modified crops are as safe and nutritious as those derived from traditional crops. The lack of

  6. Assuring process safety in the transfer of hydrogen cyanide manufacturing technology.

    Science.gov (United States)

    Maxwell, Gary R; Edwards, Victor H; Robertson, Mark; Shah, Kamal

    2007-04-11

    This paper outlines the critical issues to be addressed in the transfer of hydrogen cyanide (HCN) manufacturing technology to a licensee. Process safety management (PSM) is of critical importance because of the toxicity, flammability and reactivity of HCN. The critical issues are based on experience that DuPont has gained (1) while safely manufacturing hydrogen cyanide for over 50 years, and (2) while DuPont has safely licensed HCN technology to other firms at locations around the world. DuPont's HCN experience has been combined with Aker Kvaerner's project engineering experience to insure the safe transfer of HCN technology to a licensee.

  7. Safety and Mission Assurance Analyses Supporting Crewing Options for the International Space Station

    Science.gov (United States)

    Wade, James

    2005-12-01

    In the wake of the Columbia accident, the ISS Program and NASA were faced with deciding whether the station should be manned with three crew, two crew, or demanned completely. Initially, several analyses were conducted across the ISS Program which identified the logistics, reliability, science, and safety aspects of the various crew options. However, no one analysis could completely determine which crew option was best. The ISS team was able to identify the relevant information such that an informed, balanced decision could be made. This was accomplished by directing a reliability analysis which identified specific risks with subsystem performance, as well as the logistics analysis which identified the projected spares which would be required to maintain acceptable performance. Additionally, the safety team performed an assessment of hazard reports in order to identify any controls with a dependency on crew size. In parallel with this effort, the reliability & maintainability team performed a review of critical items (CILs) in order to identify any CIL operational workarounds which would be affected by crew size. Finally, the ISS probabilistic risk assessment (PRA) tool provided a risk versus risk comparison between the various crew options. The assessment showed little change in risk to crew when crew size was reduced from 3 to 2 crewmembers. However, the assessment showed an increase in the probability of loss of ISS should the station be demanned.

  8. A status review of photovoltaic power conversion equipment reliability, safety, and quality assurance protocols

    Energy Technology Data Exchange (ETDEWEB)

    Hacke, Peter; Lokanath, Sumanth; Williams, Paul; Vasan, Arvind; Sochor, Paul; TamizhMani, GovindaSamy; Shinohara, Hirofumi; Kurtz, Sarah

    2018-02-01

    Data indicate that the inverter is the element of the photovoltaic plant that has the highest number of service calls and the greatest operation and maintenance cost burden. This paper describes the projects and relevant background needed in developing design qualification standards that would serve to establish a minimum level of reliability, along with a review of photovoltaic inverter quality and safety standards, most of which are in their infancy. We compare stresses and levels for accelerated testing of inverters proposed in the standard drafts, and those proposed by manufacturers and purchasers of inverters. We also review bases for the methods, stress types, and stress levels for durability testing of key inverter components. Many of the test protocols appear to need more comprehensive inclusion of stress factors existing in the natural environment such as wind driven rain, dust, and grid disturbances. Further understanding of how temperature, humidity ingress, and voltage bias affect the inverters and their components is also required. We provide data indicating inconsistent quality of the inverters and the durability of components leading to greater cost for the photovoltaic plant operator. Accordingly, the recommendation for data collection within quality standards for obtaining cost of ownership metrics is made. Design validation testing using realistic operation, environmental, and connection conditions, including under end-use field conditions with feedback for continuous improvement is recommended for inclusion within a quality standard.

  9. Applications of radiation processing in combination with conventional treatments to assure food safety: New development

    Science.gov (United States)

    Lacroix, M.; Turgis, M.; Borsa, J.; Millette, M.; Salmieri, S.; Caillet, S.; Han, J.

    2009-11-01

    Spice extracts under the form of essential oils (Eos) were tested for their efficiency to increase the relative bacterial radiosensitivity (RBR) of Listeria monocytogenes, Escherichia coli and Salmonellatyphi in culture media under different atmospheric conditions. The selected Eos were tested for their ability to reduce the dose necessary to eliminate E. coli and S.typhi in medium fat ground beef (23% fat) and Listeria in ready-to-eat carrots when packed under air or under atmosphere rich in oxygen (MAP). Results have demonstrated that depending of the compound added and the combined treatment used, the RBR increased from 2 to 4 times. In order to evaluate the industrial feasibility, EOs were added in ground beef at a concentration which does not affect the taste and treated at a dose of 1.5 kGy. The content of total mesophilic aerobic, E. coli, Salmonella, total coliform, lactic acid bacteria, and Pseudomonas was determined during 28 days. The results showed that the combined treatment (radiation and EOs) can eliminate Salmonella and E. coli when done under air. When done under MAP, Pseudomonas could be eliminated and a shelf life of more than 28 days was observed. An active edible coating containing EOs was also developed and sprayed on ready-to-eat carrots before radiation treatment and Listeria was evaluated. A complete inhibition of Listeria was obtained at a dose of 0.5 kGy when applied under MAP. Our results have shown that the combination of an edible coating, MAP, and radiation can be used to maintain the safety of meat and vegetables.

  10. Applications of radiation processing in combination with conventional treatments to assure food safety: New development

    Energy Technology Data Exchange (ETDEWEB)

    Lacroix, M. [Canadian Irradiation Center, Research Laboratory in Sciences Applied to Food, INRS-Institut Armand-Frappier, 531 Boulevard des Prairies, Laval, Quebec (Canada)], E-mail: monique.lacroix@iaf.inrs.ca; Turgis, M. [Canadian Irradiation Center, Research Laboratory in Sciences Applied to Food, INRS-Institut Armand-Frappier, 531 Boulevard des Prairies, Laval, Quebec (Canada); Borsa, J. [MDS Nordion, 447 March Road, Kanata, Ontario, K2K 2P7 (Canada); Millette, M.; Salmieri, S.; Caillet, S. [Canadian Irradiation Center, Research Laboratory in Sciences Applied to Food, INRS-Institut Armand-Frappier, 531 Boulevard des Prairies, Laval, Quebec (Canada); Han, J. [Sungkyunkwan University, Department of Food Science and Biotechnology, Suwon 440-746 (Korea, Republic of)

    2009-11-15

    Spice extracts under the form of essential oils (Eos) were tested for their efficiency to increase the relative bacterial radiosensitivity (RBR) of Listeria monocytogenes, Escherichia coli and Salmonellatyphi in culture media under different atmospheric conditions. The selected Eos were tested for their ability to reduce the dose necessary to eliminate E. coli and S.typhi in medium fat ground beef (23% fat) and Listeria in ready-to-eat carrots when packed under air or under atmosphere rich in oxygen (MAP). Results have demonstrated that depending of the compound added and the combined treatment used, the RBR increased from 2 to 4 times. In order to evaluate the industrial feasibility, EOs were added in ground beef at a concentration which does not affect the taste and treated at a dose of 1.5 kGy. The content of total mesophilic aerobic, E. coli, Salmonella, total coliform, lactic acid bacteria, and Pseudomonas was determined during 28 days. The results showed that the combined treatment (radiation and EOs) can eliminate Salmonella and E. coli when done under air. When done under MAP, Pseudomonas could be eliminated and a shelf life of more than 28 days was observed. An active edible coating containing EOs was also developed and sprayed on ready-to-eat carrots before radiation treatment and Listeria was evaluated. A complete inhibition of Listeria was obtained at a dose of 0.5 kGy when applied under MAP. Our results have shown that the combination of an edible coating, MAP, and radiation can be used to maintain the safety of meat and vegetables.

  11. Expensive blood safety initiatives may offer less benefit than we think

    DEFF Research Database (Denmark)

    Kamper-Jørgensen, Mads; Hjalgrim, Henrik; Edgren, Gustaf

    2010-01-01

    Various blood safety initiatives have ensured a historically low risk of infection transmission through blood transfusion. Although further prevention of infection transmission is possible through, for example, nucleic acid testing and future introduction of pathogen inactivation, such initiatives...

  12. Processing and storage of blood components: strategies to improve patient safety

    Directory of Open Access Journals (Sweden)

    Pietersz RNI

    2015-08-01

    Full Text Available Ruby NI Pietersz, Pieter F van der Meer Department of Product and Process Development, Sanquin Blood Bank, Amsterdam, the Netherlands Abstract: This review focuses on safety improvements of blood processing of various blood components and their respective storage. A solid quality system to ensure safe and effective blood components that are traceable from a donor to the patient is the foundation of a safe blood supply. To stimulate and guide this process, National Health Authorities should develop guidelines for blood transfusion, including establishment of a quality system. Blood component therapy enabled treatment of patients with blood constituents that were missing, only thus preventing reactions to unnecessarily transfused elements. Leukoreduction prevents many adverse reactions and also improves the quality of the blood components during storage. The safety of red cells and platelets is improved by replacement of plasma with preservative solutions, which results in the reduction of isoantibodies and plasma proteins. Automation of blood collection, separation of whole blood into components, and consecutive processing steps, such as preparation of platelet concentrate from multiple donations, improves the consistent composition of blood components. Physicians can better prescribe the number of transfusions and therewith reduce donor exposure and/or the risk of pathogen transmission. Pathogen reduction in cellular blood components is the latest development in improving the safety of blood transfusions for patients. Keywords: blood components, red cell concentrates, platelet concentrates, plasma, transfusion, safety 

  13. Inactivation of TSE agents: safety of blood and blood-derived products.

    Science.gov (United States)

    Taylor, D M

    2003-02-01

    Evidence relating to whether the blood of individuals with sporadic Creutzfeldt-Jakob disease is infectious is discussed. The conclusion is that this is unproven. Similar consideration is given to the blood of individuals with variant Creutzfeldt-Jakob disease; it is concluded that there is no convincing evidence that the blood is infectious but reasons for caution are presented. There is discussion regarding factors that add to the safety of plasma-derived therapeutic products, including the capacity of the manufacturing processes to inactivate or remove infectivity by the chemical and physical processes involved. There is extended discussion regarding the inactivation of these types of agents and the few reliable options available in worst-case scenarios such as the processing of instruments used neurosurgically on known or suspected cases. The most effective method is exposure to 1 M sodium hydroxide during autoclaving at 121 degrees C. The inappropriateness of applying any of the most effective methods to blood and blood-products because they are harsh and denaturing is discussed. Nevertheless, such procedures have potential application to the plant used in the manufacture of plasma-products. Evidence is presented which suggests that even more modest treatments (the use of lower concentrations of sodium hydroxide at lower temperatures) are effective when applied to surfaces that are free from any tissue contamination, as is the case with plant used to manufacture plasma-derived products. This evidence has come from studies carried out by the gelatin manufacturers of Europe regarding the capability of their manufacturing systems to inactivate the causal agent of bovine spongiform encephalopathy.

  14. Processing and storage of blood components: strategies to improve patient safety

    OpenAIRE

    Pietersz RNI; van der Meer PF

    2015-01-01

    Ruby NI Pietersz, Pieter F van der Meer Department of Product and Process Development, Sanquin Blood Bank, Amsterdam, the Netherlands Abstract: This review focuses on safety improvements of blood processing of various blood components and their respective storage. A solid quality system to ensure safe and effective blood components that are traceable from a donor to the patient is the foundation of a safe blood supply. To stimulate and guide this process, National Health Authorities should d...

  15. [Self-sufficiency, needs, prescription and safety of blood products].

    Science.gov (United States)

    Folléa, G; Monsellier, M; Grimfeld, A; Pelletier, B; Lassale, B; Morel, P; Samama, C M; Hermine, O; Lefrère, J-J

    2013-05-01

    The current issues debate will bring together experts around the themes of self-sufficiency (in its national and European aspects) and of needs in cellular blood products. The point of view of the manufacturer and prescribers of blood products will be confronted. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  16. Review of the Constellation Level II Safety, Reliability, and Quality Assurance (SR&QA) Requirements Documents during Participation in the Constellation Level II SR&QA Forum

    Science.gov (United States)

    Cameron, Kenneth D.; Gentz, Steven J.; Beil, Robert J.; Minute, Stephen A.; Currie, Nancy J.; Scott, Steven S.; Thomas, Walter B., III; Smiles, Michael D.; Schafer, Charles F.; Null, Cynthia H.; hide

    2009-01-01

    At the request of the Exploration Systems Mission Directorate (ESMD) and the Constellation Program (CxP) Safety, Reliability; and Quality Assurance (SR&QA) Requirements Director, the NASA Engineering and Safety Center (NESC) participated in the Cx SR&QA Requirements forum. The Requirements Forum was held June 24-26; 2008, at GRC's Plum Brook Facility. The forums purpose was to gather all stakeholders into a focused meeting to help complete the process of refining the CxP to refine its Level II SR&QA requirements or defining project-specific requirements tailoring. Element prime contractors had raised specific questions about the wording and intent of many requirements in areas they felt were driving costs without adding commensurate value. NESC was asked to provide an independent and thorough review of requirements that contractors believed were driving Program costs, by active participation in the forum. This document contains information from the forum.

  17. Blood protein derivative viral safety: observations and analysis.

    OpenAIRE

    Horowitz, B.

    1990-01-01

    The well-documented viral safety of albumin arises from several factors operating in concert, including virus removal during preparation, immune neutralization, serendipitous inactivation, virus sterilization through pasteurization. Safety with respect to HBV transmission was achieved even prior to the development of sensitive screening tests for HBsAg, as can be predicted given the initial virus load and the influence of factors affecting removal and inactivation. Coagulation factor concentr...

  18. Radiation safety and quality assurance in diagnostic x-ray imaging 1999; Saeteilyturvallisuus ja laadunvarmistus roentgendiagnostiikassa 1999

    Energy Technology Data Exchange (ETDEWEB)

    Servonmaa, A. [ed.

    1999-04-01

    In the European Union, the Directive 97/43/Euratom concerning the medical use of radiation brings many new tasks to radiation users. Quality assurance, patient dose measurement, staff training and clinical audit are among the most essential of these tasks. The Finnish radiation legislation has been modified to comply with the Directive. Much work is still required for practical implementation of these rules. This report deals with applications of the medical radiation Directive. Most applications are still at the planning stage, and clear guidance is lacking. However, the users have to know in time about these plans and future duties concerning them. Experience on quality assurance and clinical audit in hospitals are especially valuable in providing practical information on benefits and problems of these practices. Other radiation related topics, such as radiation risks, radioactivity in foods, and use of radiation in other European countries, are also included in the report. (orig.)

  19. Improving health profile of blood donors as a consequence of transfusion safety efforts

    DEFF Research Database (Denmark)

    Edgren, Gustaf; Tran, Trung Nam; Hjalgrim, Henrik

    2007-01-01

    BACKGROUND: Transfusion safety rests heavily on the health of blood donors. Although they are perceived as being healthier than average, little is known about their long-term disease patterns and to which extent the blood banks' continuous efforts to optimize donor selection has resulted...... in improvements. Mortality and cancer incidence among blood donors in Sweden and Denmark was investigated. STUDY DESIGN AND METHODS: All computerized blood bank databases were compiled into one database, which was linked to national population and health data registers. With a retrospective cohort study design, 1......,110,329 blood donors were followed for up to 35 years from first computer-registered blood donation to death, emigration, or December 31, 2002. Standardized mortality and incidence ratios expressed relative risk of death and cancer comparing blood donors to the general population. RESULTS: Blood donors had...

  20. Delta check for blood groups: A step ahead in blood safety

    Directory of Open Access Journals (Sweden)

    Raj Nath Makroo

    2017-01-01

    Conclusion: Delta checks proved to be an effective tool for detecting blood group errors and prevention of accidental mismatched blood transfusions. Preanalytical errors in patient identification or sample labeling were the most frequent.

  1. Quality assurance of metabolomics.

    Science.gov (United States)

    Bouhifd, Mounir; Beger, Richard; Flynn, Thomas; Guo, Lining; Harris, Georgina; Hogberg, Helena; Kaddurah-Daouk, Rima; Kamp, Hennicke; Kleensang, Andre; Maertens, Alexandra; Odwin-DaCosta, Shelly; Pamies, David; Robertson, Donald; Smirnova, Lena; Sun, Jinchun; Zhao, Liang; Hartung, Thomas

    2015-01-01

    Metabolomics promises a holistic phenotypic characterization of biological responses to toxicants. This technology is based on advanced chemical analytical tools with reasonable throughput, including mass-spectroscopy and NMR. Quality assurance, however - from experimental design, sample preparation, metabolite identification, to bioinformatics data-mining - is urgently needed to assure both quality of metabolomics data and reproducibility of biological models. In contrast to microarray-based transcriptomics, where consensus on quality assurance and reporting standards has been fostered over the last two decades, quality assurance of metabolomics is only now emerging. Regulatory use in safety sciences, and even proper scientific use of these technologies, demand quality assurance. In an effort to promote this discussion, an expert workshop discussed the quality assurance needs of metabolomics. The goals for this workshop were 1) to consider the challenges associated with metabolomics as an emerging science, with an emphasis on its application in toxicology and 2) to identify the key issues to be addressed in order to establish and implement quality assurance procedures in metabolomics-based toxicology. Consensus has still to be achieved regarding best practices to make sure sound, useful, and relevant information is derived from these new tools.

  2. Blood Safety Status in WHO African Region Countries: Lessons Learnt from Mauritius

    Science.gov (United States)

    Sonoo, Janaki; Musango, Laurent; Nikiema, Jean Baptiste; Lapnet-Moustapha, Thomas

    2017-01-01

    In 2001, the WHO Office for Africa adopted a strategy for blood safety defining four targets. This paper describes the progress made by Mauritius in the implementation of this strategy. The blood safety indicators were collected and compared with the norms recommended by WHO. The country has formulated its blood policy and developed a strategic plan for its implementation since 2004. The total number of blood donations increased from 31,228 in 2002 to 43,742 in 2016, giving an annual blood collection rate evolving from 26.3 per 1000 inhabitants in 2002 to 34.2 per 1000 inhabitants in 2016. The percentage of voluntary donations rose from 60% to 82.5%. Since 2002, all the blood units collected have been tested for the mandatory infectious markers. The Blood Transfusion Service has been certified ISO2008-9001 and nucleic acid testing has been introduced. The preparation of blood components increased from 60% to 98.2%. The most transfused blood components were red cell concentrates, platelet concentrates, and fresh frozen plasma. In addition to transfusion activities, there were other departments performing antenatal serology, tissue typing, special investigations, and reagent preparation. Despite the progress made, some challenges remain, namely, legal framework and haemovigilance system. A regulatory system for blood needs to be established. PMID:29181226

  3. Blood Safety Status in WHO African Region Countries: Lessons Learnt from Mauritius

    Directory of Open Access Journals (Sweden)

    André Loua

    2017-01-01

    Full Text Available In 2001, the WHO Office for Africa adopted a strategy for blood safety defining four targets. This paper describes the progress made by Mauritius in the implementation of this strategy. The blood safety indicators were collected and compared with the norms recommended by WHO. The country has formulated its blood policy and developed a strategic plan for its implementation since 2004. The total number of blood donations increased from 31,228 in 2002 to 43,742 in 2016, giving an annual blood collection rate evolving from 26.3 per 1000 inhabitants in 2002 to 34.2 per 1000 inhabitants in 2016. The percentage of voluntary donations rose from 60% to 82.5%. Since 2002, all the blood units collected have been tested for the mandatory infectious markers. The Blood Transfusion Service has been certified ISO2008-9001 and nucleic acid testing has been introduced. The preparation of blood components increased from 60% to 98.2%. The most transfused blood components were red cell concentrates, platelet concentrates, and fresh frozen plasma. In addition to transfusion activities, there were other departments performing antenatal serology, tissue typing, special investigations, and reagent preparation. Despite the progress made, some challenges remain, namely, legal framework and haemovigilance system. A regulatory system for blood needs to be established.

  4. Insight into "Calculated Risk" : An Application to the Prioritization of Emerging Infectious Diseases for Blood Transfusion Safety

    NARCIS (Netherlands)

    Neslo, R. E J; Oei, W.; Janssen, M. P.|info:eu-repo/dai/nl/304818208

    Increasing identification of transmissions of emerging infectious diseases (EIDs) by blood transfusion raised the question which of these EIDs poses the highest risk to blood safety. For a number of the EIDs that are perceived to be a threat to blood safety, evidence on actual disease or

  5. Nanoparticles and the blood coagulation system. Part II: safety concerns

    Science.gov (United States)

    Ilinskaya, Anna N; Dobrovolskaia, Marina A

    2014-01-01

    Nanoparticle interactions with the blood coagulation system can be beneficial or adverse depending on the intended use of a nanomaterial. Nanoparticles can be engineered to be procoagulant or to carry coagulation-initiating factors to treat certain disorders. Likewise, they can be designed to be anticoagulant or to carry anticoagulant drugs to intervene in other pathological conditions in which coagulation is a concern. An overview of the coagulation system was given and a discussion of a desirable interface between this system and engineered nanomaterials was assessed in part I, which was published in the May 2013 issue of Nanomedicine. Unwanted pro- and anti-coagulant properties of nanoparticles represent significant concerns in the field of nanomedicine, and often hamper the development and transition into the clinic of many promising engineered nanocarriers. This part will focus on the undesirable effects of engineered nanomaterials on the blood coagulation system. We will discuss the relationship between the physicochemical properties of nanoparticles (e.g., size, charge and hydrophobicity) that determine their negative effects on the blood coagulation system in order to understand how manipulation of these properties can help to overcome unwanted side effects. PMID:23730696

  6. An Application Example Analysis of Quality Assurance Program for STELLA(Sodium Integral Effect Test Loop for Safety Simulation and Assessment) Project

    Energy Technology Data Exchange (ETDEWEB)

    Jung, Minhwan; Gam, Dayoung; Eoh, Jae-Hyuk; Jeong, Ji-Young [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2015-05-15

    KAERI has been conducting various basic R and D activities in the field of nuclear technology. In addition, KAERI is now participating in the Generation IV International Forum (GIF), preparing for the development of key technologies for Generation IV nuclear energy system, including Sodium cooled Fast Reactor (SFR) development. All of the key technologies for SFR development need an appropriate level of QA activities to achieve the GIF safety and performance objectives. Therefore, QA activities have been conducted as an essential part of the national SFR project. As a result, QAM (Quality Assurance Manual) and QAP (Quality Assurance Procedures) have been developed for the SFR project, which are based on ASME NQA-1, KEPIC QAP and the GIF Quality Management System Guidelines. In this work, the introduction background and application examples of the QA program for the STELLA project were investigated. Application of the QA for the STELLA project has great significance because the QA has been mainly applied for the nuclear power plant area in operation, which helps ensure the reliability of the test data and completeness of the research performance. Nevertheless, developing more appropriate QA procedures remains a major task because some parts of them are not applicable to the Na-experiment.

  7. [Economic analysis versus the principle of guaranteed safety in blood transfusion].

    Science.gov (United States)

    Moatti, J P; Loubière, S; Rotily, M

    2000-06-01

    This article shows that policies aimed at reducing risks of infectious agents transmissible through blood unfortunately follow a law of 'diminishing returns': increasing marginal costs have to be devoted for limited reductions in the risks of contamination through blood donations. Therefore, the economic cost-effectiveness analysis is appropriate to identify screening strategies which may minimize costs to reach a certain level of safety. Moreover, economic analysis can contribute to public debates about the level of residual risk that society is willing to accept. Empirical results from French studies about screening for hepatitis C virus (HCV) in individuals who have received blood transfusions and in blood donations are presented to illustrate these points.

  8. Guidance for the design and management of a maintenance plan to assure safety and improve the predictability of a DOE nuclear irradiation facility. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Booth, R.S.; Kryter, R.C.; Shepard, R.L.; Smith, O.L. [Oak Ridge National Lab., TN (United States); Upadhyaya, B.R. [Univ. of Tennessee, Knoxville, TN (United States). Dept. of Nuclear Engineering; Rowan, W.J.

    1994-10-01

    A program is recommended for planning the maintenance of DOE nuclear facilities that will help safety and enhance availability throughout a facility`s life cycle. While investigating the requirements for maintenance activities, a major difference was identified between the strategy suitable for a conventional power reactor and one for a research reactor facility: the latter should provide a high degree of predicted availability (referred to hereafter as ``predictability``) to its users, whereas the former should maximize total energy production. These differing operating goals necessitate different maintenance strategies. A strategy for scheduling research reactor facility operation and shutdown for maintenance must balance safety, reliability,and predicted availability. The approach developed here is based on three major elements: (1) a probabilistic risk analysis of the balance between assured reliability and predictability (presented in Appendix C), (2) an assessment of the safety and operational impact of maintenance activities applied to various components of the facility, and (3) a data base of historical and operational information on the performance and requirements for maintenance of various components. These factors are integrated into a set of guidelines for designing a new highly maintainable facility, for preparing flexible schedules for improved maintenance of existing facilities, and for anticipating the maintenance required to extend the life of an aging facility. Although tailored to research reactor facilities, the methodology has broader applicability and may therefore be used to improved the maintenance of power reactors, particularly in anticipation of peak load demands.

  9. Evaluation of fluid warmer safety using hemorheologic analysis with outdated human blood.

    Science.gov (United States)

    Kim, Hee Jung; Yoo, Sung Mook; Chung, Jae Ho; Kim, Tae Sik; Lee, Sung Ho; Son, Ho Sung

    2016-01-01

    A newly developed fluid warmer (ThermoSens®) has a direct blood warming plate, which can result in hemolysis or red blood cell injury during heating. Therefore, to evaluate the safety of heating blood products with a fluid warmer, we conducted laboratory tests to study hemolysis and erythrocyte rheology. We used outdated human blood taken from a Korean blood bank. Packed red blood cells mixed with 100 mL isotonic saline was passed through the fluid warmer. Blood flow was achieved by either gravity or 300 mmHg pressure. Blood samples were analyzed before and after heating for hemolysis marker and erythrocyte rheology parameters. The temperatures at the outlet were higher than 38°C at gravity and 300 mmHg pressure, respectively. There were no significant differences in hemolysis markers (hemoglobin, hematocrit, lactate dehydrogenase, and plasma free hemoglobin) or erythrocyte rheology (deformability, disaggregating shear stress, and aggregation index) between before and after heating (p >  0.05) except LDH at gravity (p = 0.0001). The ThermoSens® fluid warmer caused no erythrocyte injury or negative effects on rheology during heating. Regarding medical device development, hemorheologic analysis can be useful for safety evaluation of medical devices that directly contact blood for temperature modulation.

  10. Atlas-based and DTI-guided quantification of human brain cerebral blood flow: feasibility, quality assurance, spatial heterogeneity and age effects.

    Science.gov (United States)

    Hasan, Khader M; Ali, Hiba; Shad, Mujeeb U

    2013-10-01

    Accurate and noninvasive quantification of regional cerebral blood perfusion (CBF) of the human brain tissue would advance the study of the complex interplay between human brain structure and function, in both health and disease. Despite the plethora of works on CBF in gray matter, a detailed quantitative white matter perfusion atlas has not been presented on healthy adults using the International Consortium for Brain Mapping atlases. In this study, we present a host of assurance measures such as temporal stability, spatial heterogeneity and age effects of regional and global CBF in selected deep, cortical gray matter and white matter tracts identified and quantified using diffusion tensor imaging (DTI). We utilized whole brain high-resolution DTI combined with arterial spin labeling to quantify regional CBF on 15 healthy adults aged 23.2-57.1years. We present total brain and regional CBF, corresponding volume, mean diffusivity and fractional anisotropy spatial heterogeneity, and dependence on age as additional quality assurance measures to compare with published trends using both MRI and nuclear medicine methods. Total CBF showed a steady decrease with age in gray matter (r=-0.58; P=.03), whereas total CBF of white matter did not significantly change with age (r=0.11; P=.7). This quantitative report offers a preliminary baseline of CBF, volume and DTI measurements for the design of future multicenter and clinical studies utilizing noninvasive perfusion and DT-MRI. Copyright © 2013 Elsevier Inc. All rights reserved.

  11. Essence of demands of standard ISO 22000:2005 in aspect of assurances of milk health safety Istota wymagań standardu ISO 22000:2005 w aspekcie zapewnienia bezpieczeństwa zdrowotnego mleka

    Directory of Open Access Journals (Sweden)

    Justyna Górna

    2008-09-01

    Full Text Available The article presents the essence of demands of ISO 22000 as a standard which allows of control milk health safety in a more effective way. The implementation of system HACCP in the dairy companies undoubtedly make for more safety health products, however microbiological research of pasterized milk shows that it is scarce. The elementary advantage for organization which comes from food quality management system meeting demands included in standard ISO 22000 is undoubtedly assurance of legal demands concerning production of food safety and more effective control of risk of food safety. The dairy companies should aspire for implementation of more rigorous standard ISO 22000:2005.

  12. 75 FR 22758 - Notice of Intent To Prepare a Draft Environmental Impact Statement and Dam Safety Assurance...

    Science.gov (United States)

    2010-04-30

    ... the Federal action to remediate seismic, seepage, and hydrologic dam safety concerns at the Martis... existing seismic, seepage, and hydrologic issues. Compounding this risk is the large population downstream... inadequate; d. The site is in a high seismic zone and it is probable that the dam and spillway are...

  13. Risk Evaluation and Mitigation Strategies (REMSs): Are They Improving Drug Safety? A Critical Review of REMSs Requiring Elements to Assure Safe Use (ETASU).

    Science.gov (United States)

    Boudes, Pol F

    2017-06-01

    Risk Evaluation and Mitigation Strategies (REMSs) with Elements to Assure Safe Use (ETASU) are requested for drugs with significant safety risks. We reviewed REMS programs issued since 2011 to evaluate their rationales, characteristics, and consistencies, and evaluated their impact on improving drug safety. We conducted a literature search and a survey of relevant websites (FDA, manufacturers, and REMSs). ETASU characteristics were summarized. REMS risks were compared with labeled risks, including black box warnings. Forty-two programs were analyzed. Seven incorporated drugs of the same class. Most drugs (57%) were indicated for an orphan disease. A single risk was mentioned in 24 REMSs, and multiple risks in 18. Embryo-fetal toxicity and abuse or misuse were the most frequent risks. All risks were identified during clinical development but some were hypothetical. Thirty-six drugs had a black box warning. REMS risks and black box risks differed for 11 drugs. A drug with multiple indications could have a REMS for one of them but not for another. Most REMSs required prescriber training and certification, half required dispenser certification and patient enrolment. REMSs were revised multiple times and only three (7%) were discontinued. No data were available to establish whether REMSs were effective in improving drug safety. Some REMSs were deemed inefficient. REMSs with ETASU continue to be implemented but their impact on improving drug safety is still not documented. Hence, one of the main requirements of the FDA Amendments Act of 2007 is not being addressed. In addition, REMSs are complex and their logic is inconsistent; we recommend a thorough re-evaluation of the REMS program.

  14. Dengue viremia in blood donors in Northern India: Challenges of emerging dengue outbreaks to blood transfusion safety

    Directory of Open Access Journals (Sweden)

    Sadhana Mangwana

    2015-01-01

    Full Text Available Backdround: Emerging infectious diseases pose threats to the general human population; including recipients of blood transfusions. Dengue is spreading rapidly to new areas and with increasing frequency of major outbreaks. Screening blood for dengue antigens in dengue-endemic countries would be costly and should, therefore, be recommended only after careful assessment of risk for infection and cost. Aim: A prospective study was conducted to establish the magnitude of the threat that dengue poses to blood safety where it is sporadic with seasonal variations, to quantify risk and to assess that whether screening is feasible and cost-effective. Materials and Methods: Nonstructural protein 1 (NS1 antigen test was done on 1709 donations during dengue outbreak in the months August to November 2013 as an additional test using Bio-Rad Platelia Dengue NS1AG test kit which is one step sandwich format microplate enzyme immunoassay using murine monoclonal antibodies for capture and revelation. Chi-square test was used to find statistical significance. Results and Conclusions: Majority cases were whole blood, replacement, male donors with 76.10% donors in <35 years age group. About 17.85% were single donor platelet donations. NS1 antigen in all donors was negative. In the past, dengue affected mainly children who do not donate blood. With the changing trend, mean age of infection increased affecting the population that does donate blood, further reducing blood donation pool. Further studies need to be done in different geographic regions of the country during dengue transmission season to establish maximum incidence of viremic donations, rates of transfusion transmission and clinical consequences in recipients. If risk is found to be substantial, decision will be taken by the policymakers at what threshold screening should be instituted to ensure safe blood transfusion.

  15. 10 CFR 76.93 - Quality assurance.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Quality assurance. 76.93 Section 76.93 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.93 Quality assurance. The Corporation shall establish, maintain, and execute a quality assurance program satisfying each of...

  16. Leucoreduction of blood components: an effective way to increase blood safety?

    Science.gov (United States)

    Bianchi, Maria; Vaglio, Stefania; Pupella, Simonetta; Marano, Giuseppe; Facco, Giuseppina; Liumbruno, Giancarlo M.; Grazzini, Giuliano

    2016-01-01

    Over the past 30 years, it has been demonstrated that removal of white blood cells from blood components is effective in preventing some adverse reactions such as febrile non-haemolytic transfusion reactions, immunisation against human leucocyte antigens and human platelet antigens, and transmission of cytomegalovirus. In this review we discuss indications for leucoreduction and classify them into three categories: evidence-based indications for which the clinical efficacy is proven, indications based on the analysis of observational clinical studies with very consistent results and indications for which the clinical efficacy is partial or unproven. PMID:26710353

  17. Pacific Northwest Laboratory annual report for 1989 to the Assistant Secretary for Environment, Safety, and Health - Part 5: Environment, Safety, Health, and Quality Assurance

    Energy Technology Data Exchange (ETDEWEB)

    Faust, L.G.; Doctor, P.G.; Selby, J.M.

    1990-04-01

    Part 5 of the 1989 Annual Report to the US Department of Energy's Assistant Secretary for Environment, Safety, and Health presents Pacific Northwest Laboratory's progress on work performed for the Office of Environmental Guidance and Compliance, the Office of Environmental Audit, the Office of National Environmental Policy Act Project Assistance, the Office of Nuclear Safety, the Office of Safety Compliance, and the Office of Policy and Standards. For each project, as identified by the Field Work Proposal, there is an article describing progress made during fiscal year 1989. Authors of these articles represent a broad spectrum of capabilities derived from five of the seven technical centers of the Laboratory, reflecting the interdisciplinary nature of the work. 35 refs., 1 fig.

  18. Safety in the preparation of cytotoxic drugs: How to integrate gravimetric control in the quality assurance policy?

    Science.gov (United States)

    Lecordier, J; Heluin, Y; Plivard, C; Bureau, A; Mouawad, C; Chaillot, B; Lahet, J-J

    2011-02-01

    We present the way to integrate gravimetric control (GC) in a centralized preparation of cytotoxic drugs unit. Two different modalities are described. In the first strategy, the balance is located inside the isolator, whereas in the second, it is located outside in order to remove many technical and ergonomic constraints. These two modalities are compared in terms of benefits and limits. GC consists in comparing the observed weight variation with the expected weight variation using a precision balance. According to the B-in strategy, this variation is directly attributable to the weight of the cytotoxic solution injected, whereas with the B-out strategy, the weight of various additional components must be taken into account. Five hundred and seventy-seven preparations have been weighed. For "B-in" strategy, the 95% confidence interval is [1.02-1.14%] and every preparation is below the threshold of 5%. For "B-out" strategy, the 95% confidence interval is [2.34-2.63%] and 94% of preparations are below the threshold of 5%. B-in strategy is distinctly more precise than B-out strategy and can be applied to all preparations. However, B-out strategy is a feasible option in practice and enables the detection of an important mistake. All in all, results obtained from B-out strategy can be considered as a quality indicator in the production line. Results of GC are helpful in the final step of release, which the pharmacist is responsible for. Many contributions in the quality assurance policy could justify using of GC in every unit. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

  19. Pacific Northwest Laboratory annual report for 1987 to the Assistant Secretary for Environment, Safety, and Health: Part 5: Environment, safety, health, and quality assurance

    Energy Technology Data Exchange (ETDEWEB)

    Faust, L.G.; Steelman, B.L.; Selby, J.M.

    1988-02-01

    Part 5 of the 1987 Annual Report to the US Department of Energy's Assistant Secretary for Environment, Safety, and Health presents Pacific Northwest Laboratory's progress on work performed for the Office of Nuclear Safety, the Office of Environmental Guidance and Compliance, the Office of Environmental Audit, and the Office of National Environmental Policy Act Project Assistance. For each project, as identified by the Field Work Proposal, articles describe progress made during fiscal year 1987. Authors of these articles represent a broad spectrum of capabilities derived from five of the seven technical centers of the Laboratory, reflecting the interdisciplinary nature of the work.

  20. Nova laser assurance-management system

    Energy Technology Data Exchange (ETDEWEB)

    Levy, A.J.

    1983-07-18

    In a well managed project, Quality Assurance is an integral part of the management activities performed on a daily basis. Management assures successful performance within budget and on schedule by using all the good business, scientific, engineering, quality assurance, and safety practices available. Quality assurance and safety practices employed on Nova are put in perspective by integrating them into the overall function of good project management. The Nova assurance management system was developed using the quality assurance (QA) approach first implemented at LLNL in early 1978. The LLNL QA program is described as an introduction to the Nova assurance management system. The Nova system is described pictorially through the Nova configuration, subsystems and major components, interjecting the QA techniques which are being pragmatically used to assure the successful completion of the project.

  1. Microbial Performance of Food Safety Control and Assurance Activities in a Fresh Produce Processing Sector Measured Using a Microbial Assessment Scheme and Statistical Modeling.

    Science.gov (United States)

    Njage, Patrick Murigu Kamau; Sawe, Chemutai Tonui; Onyango, Cecilia Moraa; Habib, I; Njagi, Edmund Njeru; Aerts, Marc; Molenberghs, Geert

    2017-01-01

    Current approaches such as inspections, audits, and end product testing cannot detect the distribution and dynamics of microbial contamination. Despite the implementation of current food safety management systems, foodborne outbreaks linked to fresh produce continue to be reported. A microbial assessment scheme and statistical modeling were used to systematically assess the microbial performance of core control and assurance activities in five Kenyan fresh produce processing and export companies. Generalized linear mixed models and correlated random-effects joint models for multivariate clustered data followed by empirical Bayes estimates enabled the analysis of the probability of contamination across critical sampling locations (CSLs) and factories as a random effect. Salmonella spp. and Listeria monocytogenes were not detected in the final products. However, none of the processors attained the maximum safety level for environmental samples. Escherichia coli was detected in five of the six CSLs, including the final product. Among the processing-environment samples, the hand or glove swabs of personnel revealed a higher level of predicted contamination with E. coli , and 80% of the factories were E. coli positive at this CSL. End products showed higher predicted probabilities of having the lowest level of food safety compared with raw materials. The final products were E. coli positive despite the raw materials being E. coli negative for 60% of the processors. There was a higher probability of contamination with coliforms in water at the inlet than in the final rinse water. Four (80%) of the five assessed processors had poor to unacceptable counts of Enterobacteriaceae on processing surfaces. Personnel-, equipment-, and product-related hygiene measures to improve the performance of preventive and intervention measures are recommended.

  2. Availability, safety, and quality of blood for transfusion in the Americas

    Directory of Open Access Journals (Sweden)

    José Ramiro Cruz

    2003-03-01

    Full Text Available OBJECTIVES: This article has two objectives: (1 to present for countries and territories of the Region of the Americas data on the number of blood donations, proportion of voluntary blood donors versus remunerated blood donors, coverage of screening for infectious agents, and separation of donated blood into its components and (2 to explore the relationships of those characteristics with economic and organizational factors in the countries and territories. METHODS: We carried out comparative analyses using population and health information gathered annually by the Pan American Health Organization (PAHO from national health officials from the countries in the Americas, as well as economic information (gross national product (GNP per capita obtained from publications of the World Bank. RESULTS: There is a direct correlation between the availability of blood for transfusion and GNP per capita. Seven countries with a GNP per capita above US$ 10 000 per year account for 38% of the Regional population but 68% of the Regional blood donations. Voluntary blood donation is more common in the countries with better blood availability. There is no association between GNP per capita and coverage of screening for infectious agents. Nevertheless, of the six countries with a GNP per capita below US$ 1 000, only one of the six screens all units for human immunodeficiency virus (HIV, hepatitis C virus (HCV, and hepatitis B surface antigen (HBsAg. Countries with a higher proportion of voluntary blood donors tend to have lower prevalence rates of infectious markers. Separation of blood into its components is also more common in countries with higher blood donation rates. CONCLUSIONS: The availability, safety, and quality of blood for transfusion in the Americas needs to be improved. As part of that effort, national policies and strategies must be put into place so that the resources already allocated for blood services are better utilized.

  3. The Center for HIV/AIDS Vaccine Immunology (CHAVI) Multi-site Quality Assurance Program for Cryopreserved Human Peripheral Blood Mononuclear Cells

    Science.gov (United States)

    Sarzotti-Kelsoe, Marcella; Needham, Leila K.; Rountree, Wes; Bainbridge, John; Gray, Clive M.; Fiscus, Susan A.; Ferrari, Guido; Stevens, Wendy S.; Stager, Susan L.; Binz, Whitney; Louzao, Raul; Long, Kristy O.; Mokgotho, Pauline; Moodley, Niranjini; Mackay, Melanie; Kerkau, Melissa; McMillion, Takesha; Kirchherr, Jennifer; Soderberg, Kelly A.; Haynes, Barton F.; Denny, Thomas N.

    2014-01-01

    The Center for HIV/AIDS Vaccine Immunology (CHAVI) consortium was established to determine the host and virus factors associated with HIV transmission, infection and containment of virus replication, with the goal of advancing the development of an HIV protective vaccine. Studies to meet this goal required the use of cryopreserved Peripheral Blood Mononuclear Cell (PBMC) specimens, and therefore it was imperative that a quality assurance (QA) oversight program be developed to monitor PBMC samples obtained from study participants at multiple international sites. Nine site-affiliated laboratories in Africa and the USA collected and processed PBMCs, and cryopreserved PBMC were shipped to CHAVI repositories in Africa and the USA for long-term storage. A three-stage program was designed, based on Good Clinical Laboratory Practices (GCLP), to monitor PBMC integrity at each step of this process. The first stage evaluated the integrity of fresh PBMCs for initial viability, overall yield, and processing time at the site-affiliated laboratories (Stage 1); for the second stage, the repositories determined post-thaw viability and cell recovery of cryopreserved PBMC, received from the site-affiliated laboratories (Stage 2); the third stage assessed the long-term specimen storage at each repository (Stage 3). Overall, the CHAVI PBMC QA oversight program results highlight the relative importance of each of these stages to the ultimate goal of preserving specimen integrity from peripheral blood collection to long-term repository storage. PMID:24910414

  4. Revaluing donor and recipient bodies in the globalised blood economy: transitions in public policy on blood safety in the United Kingdom.

    Science.gov (United States)

    Busby, Helen; Kent, Julie; Farrell, Anne-Maree

    2014-01-01

    The clinical use of blood has a long history, but its apparent stability belies the complexity of contemporary practices in this field. In this article, we explore how the production, supply and deployment of blood products are socially mediated, drawing on theoretical perspectives from recent work on 'tissue economies'. We highlight the ways in which safety threats in the form of infections that might be transmitted through blood and plasma impact on this tissue economy and how these have led to a revaluation of donor bodies and restructuring of blood economies. Specifically, we consider these themes in relation to the management of recent threats to blood safety in the United Kingdom. We show that the tension between securing the supply of blood and its products and ensuring its safety may give rise to ethical concerns and reshape relations between donor and recipient bodies.

  5. A risk-based, product-level approach for assuring aquatic environmental safety of cleaning products in the context of sustainability: The Environmental Safety Check (ESC) scheme of the A.I.S.E. Charter for Sustainable Cleaning.

    Science.gov (United States)

    Pickup, John Alexander; Dewaele, Joost; Furmanski, Nicola L; Kowalczyk, Agnieszka; Luijkx, Gerard Ca; Mathieu, Sophie; Stelter, Norbert

    2017-01-01

    Cleaning products have long been a focus of efforts to improve sustainability and assure safety for the aquatic environment when disposed of after use. The latter is addressed at ingredient level through environmental risk assessment, including in formal frameworks such as REACH. Nevertheless, in the context of programs to improve overall sustainability, stakeholders demand both environmental safety assurance and progress at product level. Current product-level approaches for aquatic toxicity (e.g., USEtox™, Critical Dilution Volume) can be seen as predominantly hazard-based. The more logical approach would be risk-based, because ecotoxicity is generally threshold-dependent and hazard-based assessment produces conflicts with risk-based learnings. The development of a risk-based approach to assess formulated products is described: the International Association for Soaps, Detergents and Maintenance Products (A.I.S.E.) Charter Environmental Safety Check (ESC), which is consistent with the scientific principles underlying REACH. This is implemented through a simple spreadsheet tool and internal database of ingredient parameters including predicted no-effect concentration (PNEC) and removal rate. A novel feature is applying market volume information for both product types and ingredients to permit a risk-based calculation. To pass the ESC check, the projected environmental safety ratio (PESR) for each ingredient as formulated and dosed (unless cleared by a published risk assessment or exempted as inherently low risk) must be less than 1. The advantages of a risk-based approach are discussed. The strengths and limitations of various possible approaches to standard-setting, product-ranking and driving continuous improvement in respect of potential ecotoxic impacts on the aquatic environment are considered. It is proposed that as ecotoxicity is generally accepted to be threshold-dependent, with no effect below the threshold, the most constructive approach to continuous

  6. Quality assurance

    Energy Technology Data Exchange (ETDEWEB)

    Gillespie, B.M.; Gleckler, B.P.

    1995-06-01

    This section of the 1994 Hanford Site Environmental Report summarizes the quality assurance and quality control practices of Hanford Site environmental monitoring and surveillance programs. Samples are analyzed according to documented standard analytical procedures. This section discusses specific measures taken to ensure quality in project management, sample collection, and analytical results.

  7. Systemic Assurance

    Science.gov (United States)

    2015-07-31

    benefits. The first is direct: Cost- effective and rapid recertification is essential to support the development of systems that must adapt to changes...simulations, cyber-physical robotic systems, and extremely large commercial Java programs. An important goal is to develop incrementally compostable ...combinations of models, practices, and tools for obtaining the most cost- and schedule- effective combinations for the assurance of necessary system

  8. Utilizing Radiofrequency Identification Technology to Improve Safety and Management of Blood Bank Supply Chains.

    Science.gov (United States)

    Coustasse, Alberto; Meadows, Pamela; Hall, Robert S; Hibner, Travis; Deslich, Stacie

    2015-11-01

    The importance of efficiency in the supply chain of perishable products, such as the blood products used in transfusion services, cannot be overstated. Many problems can occur, such as the outdating of products, inventory management issues, patient misidentification, and mistransfusion. The purpose of this article was to identify the benefits and barriers associated with radiofrequency identification (RFID) usage in improving the blood bank supply chain. The methodology for this study was a qualitative literature review following a systematic approach. The review was limited to sources published from 2000 to 2014 in the English language. Sixty-five sources were found, and 56 were used in this research study. According to the finding of the present study, there are numerous benefits and barriers to RFID utilization in blood bank supply chains. RFID technology offers several benefits with regard to blood bank product management, including decreased transfusion errors, reduction of product loss, and more efficient inventory management. Barriers to RFID implementation include the cost associated with system implementation and patient privacy issues. Implementation of an RFID system can be a significant investment. However, when observing the positive impact that such systems may have on transfusion safety and inventory management, the cost associated with RFID systems can easily be justified. RFID in blood bank inventory management is vital to ensuring efficient product inventory management and positive patient outcomes.

  9. Forum for debate: Safety of allogeneic blood transfusion alternatives in the surgical/critically ill patient.

    Science.gov (United States)

    Muñoz Gómez, M; Bisbe Vives, E; Basora Macaya, M; García Erce, J A; Gómez Luque, A; Leal-Noval, S R; Colomina, M J; Comin Colet, J; Contreras Barbeta, E; Cuenca Espiérrez, J; Garcia de Lorenzo Y Mateos, A; Gomollón García, F; Izuel Ramí, M; Moral García, M V; Montoro Ronsano, J B; Páramo Fernández, J A; Pereira Saavedra, A; Quintana Diaz, M; Remacha Sevilla, Á; Salinas Argente, R; Sánchez Pérez, C; Tirado Anglés, G; Torrabadella de Reinoso, P

    2015-12-01

    In recent years, several safety alerts have questioned or restricted the use of some pharmacological alternatives to allogeneic blood transfusion in established indications. In contrast, there seems to be a promotion of other alternatives, based on blood products and/or antifibrinolytic drugs, which lack a solid scientific basis. The Multidisciplinary Autotransfusion Study Group and the Anemia Working Group España convened a multidisciplinary panel of 23 experts belonging to different healthcare areas in a forum for debate to: 1) analyze the different safety alerts referred to certain transfusion alternatives; 2) study the background leading to such alternatives, the evidence supporting them, and their consequences for everyday clinical practice, and 3) issue a weighted statement on the safety of each questioned transfusion alternative, according to its clinical use. The members of the forum maintained telematics contact for the exchange of information and the distribution of tasks, and a joint meeting was held where the conclusions on each of the items examined were presented and discussed. A first version of the document was drafted, and subjected to 4 rounds of review and updating until consensus was reached (unanimously in most cases). We present the final version of the document, approved by all panel members, and hope it will be useful for our colleagues. Copyright © 2015 Elsevier España, S.L.U. and SEMICYUC. All rights reserved.

  10. Contribution of the Retrovirus Epidemiology Donor Study (REDS to research on blood transfusion safety in Brazil

    Directory of Open Access Journals (Sweden)

    Paula Loureiro

    2014-04-01

    Full Text Available The Retrovirus Epidemiology Donor Study (REDS program was established in the United States in 1989 with the purpose of increasing blood transfusion safety in the context of the HIV/AIDS and human T-lymphotropic virus epidemics. REDS and its successor, REDS-II were at first conducted in the US, then expanded in 2006 to include international partnerships with Brazil and China. In 2011, a third wave of REDS renamed the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III was launched. This seven-year research program focuses on both blood banking and transfusion medicine research in the United States of America, Brazil, China, and South Africa. The main goal of the international programs is to reduce and prevent the transmission of HIV/AIDS and other known and emerging infectious agents through transfusion, and to address research questions aimed at understanding global issues related to the availability of safe blood. This article describes the contribution of REDS-II to transfusion safety in Brazil. Articles published from 2010 to 2013 are summarized, including database analyses to characterize blood donors, deferral rates, and prevalence, incidence and residual risk of the main blood-borne infections. Specific studies were developed to understand donor motivation, the impact of the deferral questions, risk factors and molecular surveillance among HIV-positive donors, and the natural history of Chagas disease. The purpose of this review is to disseminate the acquired knowledge and briefly summarize the findings of the REDS-II studies conducted in Brazil as well as to introduce the scope of the REDS-III program that is now in progress and will continue through 2018.

  11. Blood cytokines as biomarkers of in vivo toxicity in preclinical safety assessment: considerations for their use.

    Science.gov (United States)

    Tarrant, Jacqueline M

    2010-09-01

    In the drive to develop drugs with well-characterized and clinically monitorable safety profiles, there is incentive to expand the repertoire of safety biomarkers for toxicities without routine markers or premonitory detection. Biomarkers in blood are pursued because of specimen accessibility, opportunity for serial monitoring, quantitative measurement, and the availability of assay platforms. Cytokines, chemokines, and growth factors (here referred to collectively as cytokines) show robust modulation in proximal events of inflammation, immune response, and repair. These are key general processes in many toxicities; therefore, cytokines are commonly identified during biomarker discovery studies. In addition, multiplexed cytokine immunoassays are easily applied to biomarker discovery and routine toxicity studies to measure blood cytokines. However, cytokines pose several challenges as safety biomarkers because of a short serum half-life; low to undetectable baseline levels; lack of tissue-specific or toxicity-specific expression; complexities related to cytokine expression with multiorgan involvement; and species, strain, and interindividual differences. Additional challenges to their application are caused by analytical, methodological, and study design-related variables. A final consideration is the strength of the relationship between changes in cytokine levels and the development of phenotypic or functional manifestations of toxicity. These factors should inform the integrated judgment-based qualification of novel biomarkers in preclinical, and potentially clinical, risk assessment. The dearth of robust, predictive cytokine biomarkers for specific toxicities is an indication of the significant complexity of these challenges. This review will consider the current state of the science and recommendations for appropriate application of cytokines in preclinical safety assessment.

  12. [Medical safety management in the blood collection center of clinical laboratory].

    Science.gov (United States)

    Yoshida, Hiroshi; Kisugi, Reiko; Koike, Masaru

    2011-03-01

    Safety management is essential for providing patients with medical services. Our hospital, opened at Kashiwa in 1987, has been building up systems and taking a number of steps to reduce the blood collection related problems, including venipuncture-related infection, nerve injury, and vasovagal reflex with syncope in accordance with guidelines for the standard method of venipuncture blood collection. We also have made efforts for improving medical services, including reductions in patient waiting time and prevention of patient misidentification, medical test malpractice, and patient privacy. However, ultimately, it is of obvious significance to educate and train communication skills for humanity and friendly kindness because most of medical accidents are basically attributed to communication errors between patients and medical staff.

  13. Patient involvement in blood transfusion safety: patients' and healthcare professionals' perspective.

    Science.gov (United States)

    Davis, R; Murphy, M F; Sud, A; Noel, S; Moss, R; Asgheddi, M; Abdur-Rahman, I; Vincent, C

    2012-08-01

    Blood transfusion is one of the major areas where serious clinical consequences, even death, related to patient misidentification can occur. In the UK, healthcare professional compliance with pre-transfusion checking procedures which help to prevent misidentification errors is poor. Involving patients at a number of stages in the transfusion pathway could help prevent the occurrence of these incidents. To investigate patients' willingness to be involved and healthcare professionals' willingness to support patient involvement in pre-transfusion checking behaviours. A cross-sectional design was employed assessing willingness to participate in pre-transfusion checking behaviours (patient survey) and willingness to support patient involvement (healthcare professional survey) on a scale of 1-7. One hundred and ten patients who had received a transfusion aged between 18 and 93 (60 male) and 123 healthcare professionals (doctors, nurses and midwives) involved in giving blood transfusions to patients. Mean scores for patients' willingness to participate in safety-relevant transfusion behaviours and healthcare professionals' willingness to support patient involvement ranged from 4.96-6.27 to 4.53-6.66, respectively. Both groups perceived it most acceptable for patients to help prevent errors or omissions relating to their hospital identification wristband. Neither prior experience of receiving a blood transfusion nor professional role of healthcare staff had an effect on attitudes towards patient participation. Overall, both patients and healthcare professionals view patient involvement in transfusion-related behaviours quite favourably and appear in agreement regarding the behaviours patients should adopt an active role in. Further work is needed to determine the effectiveness of this approach to improve transfusion safety. © 2012 The Authors. Transfusion Medicine © 2012 British Blood Transfusion Society.

  14. Robustness of arterial blood gas analysis for assessment of respiratory safety pharmacology in rats.

    Science.gov (United States)

    Whiteside, Garth T; Hummel, Michele; Boulet, Jamie; Beyenhof, Jessica D; Strenkowski, Bryan; John, Janet Dell; Knappenberger, Terri; Maselli, Harry; Koetzner, Lee

    2016-01-01

    Whole body plethysmography using unrestrained animals is a common technique for assessing the respiratory risk of new drugs in safety pharmacology studies in rats. However, wide variations in experimental technique make cross laboratory comparison of data difficult and raise concerns that non-appropriate conditions may mask the deleterious effects of test compounds - in particular with suspected respiratory depressants. Therefore, the objective of this study was to evaluate the robustness of arterial blood gas analysis as an alternative to plethysmography in rats. We sought to do this by assessing the effect of different vehicles and times post-surgical catheterization on blood gas measurements, in addition to determining sensitivity to multiple opioids. Furthermore, we determined intra-lab variability from multiple datasets utilizing morphine and generated within a single lab and lastly, inter-lab variability was measured by comparing datasets generated in two separate labs. Overall, our data show that arterial blood gas analysis is a measure that is both flexible in terms of experimental conditions and highly sensitive to respiratory depressants, two key limitations when using plethysmography. As such, our data strongly advocate the adoption of arterial blood gas analysis as an investigative approach to reliably examine the respiratory depressant effects of opioids. Copyright © 2015 Elsevier Inc. All rights reserved.

  15. Drivers for change: Western Australia Patient Blood Management Program (WA PBMP), World Health Assembly (WHA) and Advisory Committee on Blood Safety and Availability (ACBSA).

    Science.gov (United States)

    Farmer, Shannon L; Towler, Simon C; Leahy, Michael F; Hofmann, Axel

    2013-03-01

    Patient blood management is now high on national and international health-system agendas. Serious supply challenges as a result of changing population dynamics, escalating cost of blood, ongoing safety challenges and questions about transfusion efficacy and outcomes are necessitating change in transfusion practice. Numerous initiatives are underway to bring about change, including the institution of comprehensive patient blood management programmes. In 2008, the Western Australia Department of Health initiated a 5-year project to implement a comprehensive health-system-wide Patient Blood Management Program with the aim of improving patient outcomes while reducing costs. Clinically, the Program was structured on the three pillars of patient blood management, namely (1) optimising the patient's own red cell mass, (2) minimising blood loss and (3) harnessing and optimising the patient-specific anaemia reserve. It employs multiple strategies to bring about a cultural change from a blood-product focus to a patient focus. This Program was undertaken in a State that already had one of the lowest red blood cell issuance rates per 1000 population in the developed world (30.47 red blood cell units per 1000 population). The Program identified reasons and drivers for practice change. From financial years 2008-09 to 2011-12, issuance has progressively decreased in Western Australia to 27.54 units per 1000. During the same years, despite increasing activity, total issuance of red blood cells to the entire State decreased from 70,103 units to 65,742. Nationally and internationally, other initiatives are underway to bring about change and implement patient blood management. The World Health Assembly in May 2010 adopted resolution WHA63.12 endorsing patient blood management and its three-pillar application. The United States Advisory Committee on Blood Safety and Availability met in 2011 to consider the implications of this resolution and its implementation. Copyright © 2012

  16. Managing blood pressure control in Asian patients: safety and efficacy of losartan

    Science.gov (United States)

    Cheung, Tommy Tsang; Cheung, Bernard Man Yung

    2014-01-01

    Hypertension is common in Asian populations and is a major cause of cardiovascular diseases. The prevalence of hypertension is increasing in many Asian countries. The overall prevalence of hypertension in India and the People’s Republic of China has been estimated to be 20.6% in men and 22.6% in women. However, the rates of detection, treatment, and control of hypertension remain low in Asia. This reflects a low level of literacy and education, as well as a low level of access to medical care. To overcome these obstacles, strategies targeted at education, promotion, and optimization of medical care, are crucial to achieve target blood pressure control. Angiotensin receptor blockers are one of the first-line treatments for essential hypertension because they confer better cardiovascular outcomes. Losartan has been widely evaluated for the management of hypertension. Although some studies suggested that the blood pressure-lowering effect of losartan is perhaps lower than for other angiotensin receptor blockers, losartan has been demonstrated to be beneficial in terms of renal protection in patients with diabetes, heart failure resulting from either systolic or diastolic dysfunction, and diuretic-induced hyperuricemia. However, most of these data were obtained from Caucasian populations. The efficacy and safety of losartan in Asian populations may be different because of genetic and ethnic variations. Therefore, the efficacy and safety of losartan in Asian patients with hypertension warrant further study. PMID:24672231

  17. Emerging Infectious Diseases and Blood Safety: Modeling the Transfusion-Transmission Risk.

    Science.gov (United States)

    Kiely, Philip; Gambhir, Manoj; Cheng, Allen C; McQuilten, Zoe K; Seed, Clive R; Wood, Erica M

    2017-07-01

    While the transfusion-transmission (TT) risk associated with the major transfusion-relevant viruses such as HIV is now very low, during the last 20 years there has been a growing awareness of the threat to blood safety from emerging infectious diseases, a number of which are known to be, or are potentially, transfusion transmissible. Two published models for estimating the transfusion-transmission risk from EIDs, referred to as the Biggerstaff-Petersen model and the European Upfront Risk Assessment Tool (EUFRAT), respectively, have been applied to several EIDs in outbreak situations. We describe and compare the methodological principles of both models, highlighting their similarities and differences. We also discuss the appropriateness of comparing results from the two models. Quantitating the TT risk of EIDs can inform decisions about risk mitigation strategies and their cost-effectiveness. Finally, we present a qualitative risk assessment for Zika virus (ZIKV), an EID agent that has caused several outbreaks since 2007. In the latest and largest ever outbreak, several probable cases of transfusion-transmission ZIKV have been reported, indicating that it is transfusion-transmissible and therefore a risk to blood safety. We discuss why quantitative modeling the TT risk of ZIKV is currently problematic. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

  18. 10 CFR 830.122 - Quality assurance criteria.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Quality assurance criteria. 830.122 Section 830.122 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.122 Quality assurance criteria. The QAP must address the following management, performance, and assessment criteria: (a...

  19. Healthy Family 2009: Assuring Healthy Aging

    Science.gov (United States)

    ... Issue Past Issues Healthy Family 2009 Assuring Healthy Aging Past Issues / Winter 2009 Table of Contents For ... please turn Javascript on. 7 Smart Steps to Aging Well 1. Control Blood Pressure You can have ...

  20. Malaria and blood transfusion: major issues of blood safety in malaria-endemic countries and strategies for mitigating the risk of Plasmodium parasites.

    Science.gov (United States)

    Abdullah, Saleh; Karunamoorthi, Kaliyaperumal

    2016-01-01

    Malaria inflicts humankind over centuries, and it remains as a major threat to both clinical medicine and public health worldwide. Though hemotherapy is a life-sustaining modality, it continues to be a possible source of disease transmission. Hence, hemovigilance is a matter of grave concern in the malaria-prone third-world countries. In order to pursue an effective research on hemovigilance, a comprehensive search has been conducted by using the premier academic-scientific databases, WHO documents, and English-language search engines. One hundred two appropriate articles were chosen for data extraction, with a particular reference to emerging pathogens transmitted through blood transfusion, specifically malaria. Blood donation screening is done through microscopic examination and immunological assays to improve the safety of blood products by detection major blood-borne pathogens, viz., HIV, HBV, HCV, syphilis, and malarial parasites. Transfusion therapy significantly dwindles the preventable morbidity and mortality attributed to various illnesses and diseases, particularly AIDS, tuberculosis, and malaria. Examination of thick and thin blood smears are performed to detect positivity and to identify the Plasmodium species, respectively. However, all of these existing diagnostic tools have their own limitations in terms of sensitivity, specificity, cost-effectiveness, and lack of resources and skilled personnel. Globally, despite the mandate need of screening blood and its components according to the blood-establishment protocols, it is seldom practiced in the low-income/poverty-stricken settings. In addition, each and every single phase of transfusion chain carries sizable inherent risks from donors to recipients. Interestingly, opportunities also lie ahead to enhance the safety of blood-supply chain and patients. It can be achieved through sustainable blood-management strategies like (1) appropriate usage of precise diagnostic tools/techniques, (2) promoting

  1. Evaluation of the efficacy and safety of rivaroxaban using a computer model for blood coagulation.

    Directory of Open Access Journals (Sweden)

    Rolf Burghaus

    Full Text Available Rivaroxaban is an oral, direct Factor Xa inhibitor approved in the European Union and several other countries for the prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery and is in advanced clinical development for the treatment of thromboembolic disorders. Its mechanism of action is antithrombin independent and differs from that of other anticoagulants, such as warfarin (a vitamin K antagonist, enoxaparin (an indirect thrombin/Factor Xa inhibitor and dabigatran (a direct thrombin inhibitor. A blood coagulation computer model has been developed, based on several published models and preclinical and clinical data. Unlike previous models, the current model takes into account both the intrinsic and extrinsic pathways of the coagulation cascade, and possesses some unique features, including a blood flow component and a portfolio of drug action mechanisms. This study aimed to use the model to compare the mechanism of action of rivaroxaban with that of warfarin, and to evaluate the efficacy and safety of different rivaroxaban doses with other anticoagulants included in the model. Rather than reproducing known standard clinical measurements, such as the prothrombin time and activated partial thromboplastin time clotting tests, the anticoagulant benchmarking was based on a simulation of physiologically plausible clotting scenarios. Compared with warfarin, rivaroxaban showed a favourable sensitivity for tissue factor concentration inducing clotting, and a steep concentration-effect relationship, rapidly flattening towards higher inhibitor concentrations, both suggesting a broad therapeutic window. The predicted dosing window is highly accordant with the final dose recommendation based upon extensive clinical studies.

  2. Evaluation of the Efficacy and Safety of Rivaroxaban Using a Computer Model for Blood Coagulation

    Science.gov (United States)

    Burghaus, Rolf; Coboeken, Katrin; Gaub, Thomas; Kuepfer, Lars; Sensse, Anke; Siegmund, Hans-Ulrich; Weiss, Wolfgang; Mueck, Wolfgang; Lippert, Joerg

    2011-01-01

    Rivaroxaban is an oral, direct Factor Xa inhibitor approved in the European Union and several other countries for the prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery and is in advanced clinical development for the treatment of thromboembolic disorders. Its mechanism of action is antithrombin independent and differs from that of other anticoagulants, such as warfarin (a vitamin K antagonist), enoxaparin (an indirect thrombin/Factor Xa inhibitor) and dabigatran (a direct thrombin inhibitor). A blood coagulation computer model has been developed, based on several published models and preclinical and clinical data. Unlike previous models, the current model takes into account both the intrinsic and extrinsic pathways of the coagulation cascade, and possesses some unique features, including a blood flow component and a portfolio of drug action mechanisms. This study aimed to use the model to compare the mechanism of action of rivaroxaban with that of warfarin, and to evaluate the efficacy and safety of different rivaroxaban doses with other anticoagulants included in the model. Rather than reproducing known standard clinical measurements, such as the prothrombin time and activated partial thromboplastin time clotting tests, the anticoagulant benchmarking was based on a simulation of physiologically plausible clotting scenarios. Compared with warfarin, rivaroxaban showed a favourable sensitivity for tissue factor concentration inducing clotting, and a steep concentration–effect relationship, rapidly flattening towards higher inhibitor concentrations, both suggesting a broad therapeutic window. The predicted dosing window is highly accordant with the final dose recommendation based upon extensive clinical studies. PMID:21526168

  3. Safety and quality assurance management in radiation oncology, What is the role for qualiticians?: example of the Centre Alexis Vautrin; Management de la qualite et de la securite en radiotherapie. Quel role pour les qualiticiens?: exemple au centre Alexis-Vautrin

    Energy Technology Data Exchange (ETDEWEB)

    Aigle, D. [Centre Alexis-Vautrin, Unite qualite et organisation, 54 - Vandoeuvre-les-Nancy (France); Sobczyk, C.; Androni, M.L.; Peiffert, D.; Beckendorf, V.; Marchesi, V.; Buchheit, I.; Noel, A. [Centre Alexis-Vautrin, Dept. de Radiotherapie, 54 - Vandoeuvre-les-Nancy (France)

    2009-10-15

    Since 2007, the Centre Alexis-Vautrin Cancer Institute in Nancy began its safety and quality assurance management policy in the department of radiation oncology. This development induced a collaborative work flow between the quality unit and the department of radiation oncology, with a definition of the responsibilities. The quality unit provides its methodology for the quality assurance, the professionals of the radiation oncology department their expertise. In parallel, a quality referee was nominated in the radiation oncology department to implement the projects for improvement, linked with the quality assurance unit, and under the control of the radiation oncology department staff. (authors)

  4. [Roundtables of SFTS Congress 2013: Needs, indications and safety of blood products; self-sufficiency in blood products].

    Science.gov (United States)

    Hermine, O; Lassale, B; Morel, P; Samama, C M; Folléa, G; Monsellier, M; Noël, S; Tissot, J-D; Lefrère, J-J

    2014-06-01

    The current issues debate brings together experts around the themes of self-sufficiency (in its national and European aspects) and of needs in cellular blood products. The point of view of the manufacturer and prescribers of blood products are confronted. Copyright © 2014. Published by Elsevier SAS.. All rights reserved.

  5. The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Park Kyung

    2012-03-01

    Full Text Available Abstract Background Second-generation drug-eluting stents (DES have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES. In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI. A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT is used more commonly than doubling the dose of clopidogrel in high-risk patients. Methods In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES and antiplatelet regimen (TAT vs DDAT. The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen. Discussion The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI. Trial registration ClincalTrials.gov number NCT01267734.

  6. The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial: study protocol for a randomized controlled trial

    Science.gov (United States)

    2012-01-01

    Background Second-generation drug-eluting stents (DES) have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES) is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES). In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI). A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT)) was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS) patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT)) is used more commonly than doubling the dose of clopidogrel in high-risk patients. Methods In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES) and antiplatelet regimen (TAT vs DDAT). The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen. Discussion The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI. Trial registration ClincalTrials.gov number NCT01267734. PMID:22463698

  7. Redefining and expanding quality assurance.

    Science.gov (United States)

    Robins, J L

    1992-12-01

    To meet the current standards of excellence necessary for blood establishments, we have learned from industry that a movement toward organization-wide quality assurance/total quality management must be made. Everyone in the organization must accept responsibility for participating in providing the highest quality products and services. Quality must be built into processes and design systems to support these quality processes. Quality assurance has been redefined to include a quality planning function described as the most effective way of designing quality into processes. A formalized quality planning process must be part of quality assurance. Continuous quality improvement has been identified as the strategy every blood establishment must support while striving for error-free processing as the long-term objective. The auditing process has been realigned to support and facilitate this same objective. Implementing organization-wide quality assurance/total quality management is one proven plan for guaranteeing the quality of the 20 million products that are transfused into 4 million patients each year and for moving toward the new order.

  8. Blood

    Science.gov (United States)

    ... organs and show how well treatments are working. Problems with your blood may include bleeding disorders, excessive clotting and platelet disorders. If you lose too much blood, you may need a transfusion. NIH: National Heart, Lung, and Blood Institute

  9. Strengthening of the Blood Safety System in the National Blood Transfusion Service - Implementation of the European Union IPA Project - at the Institute for Transfusion Medicine of the Republic of Macedonia

    Directory of Open Access Journals (Sweden)

    Rada M. Grubovic

    2014-09-01

    Full Text Available The Safety of the Blood Supply in any country is of utmost importance to safeguard patients from serious adverse events of blood transfusion. Implementation of a Quality System in the Blood Transfusion Service, with support of Government and Ministry of Health is a key element to guarantee safe blood. The IPA TAIB 2009 project - Strengthening of the Blood Safety System executed in 2013/14 provided the means to start implementing a Quality System in the Institute for Transfusion Medicine of the Republic of Macedonia. This project aimed to ultimately bring the Blood Transfusion Service to European Union standards, allowing the exchange of blood components and all other types of collaboration with other European Union countries in future. The project put the basis for unification of blood transfusion standards and operating procedures in the whole country as well as set up essential education of blood transfusion personnel.

  10. Experiment Safety Assurance Package for the 40- to 52-GWd/MT Burnup Phase of Mixed Oxide Fuel Irradiation in Small I-hole Positions in the Advanced Test Reactor

    Energy Technology Data Exchange (ETDEWEB)

    S. T. Khericha; R. C. Pedersen

    2003-09-01

    This experiment safety assurance package (ESAP) is a revision of the last mixed uranium and plutonium oxide (MOX) ESAP issued in June 2002). The purpose of this revision is to provide a basis to continue irradiation up to 52 GWd/MT burnup [as predicted by MCNP (Monte Carlo N-Particle) transport code The last ESAP provided basis for irradiation, at a linear heat generation rate (LHGR) no greater than 9 kW/ft, of the highest burnup capsule assembly to 50 GWd/MT. This ESAP extends the basis for irradiation, at a LHGR no greater than 5 kW/ft, of the highest burnup capsule assembly from 50 to 52 GWd/MT.

  11. Compliance Assurance Monitoring

    Science.gov (United States)

    Compliance assurance monitoring is intended to provide a reasonable assurance of compliance with applicable requirements under the Clean Air Act for large emission units that rely on pollution control device equipment to achieve compliance.

  12. Performance and safety of femoral central venous catheters in pediatric autologous peripheral blood stem cell collection.

    Science.gov (United States)

    Cooling, Laura; Hoffmann, Sandra; Webb, Dawn; Yamada, Chisa; Davenport, Robertson; Choi, Sung Won

    2017-12-01

    Autologous peripheral blood hematopoietic progenitor cell collection (A-HPCC) in children typically requires placement of a central venous catheter (CVC) for venous access. There is scant published data regarding the performance and safety of femoral CVCs in pediatric A-HPCC. Seven-year, retrospective study of A-HPCC in pediatric patients collected between 2009 and January 2017. Inclusion criteria were an age ≤ 21 years and A-HPCC using a femoral CVC for venous access. Femoral CVC performance was examined by CD34 collection rate, inlet rate, collection efficiency (MNC-FE, CD34-FE), bleeding, flow-related adverse events (AE), CVC removal, and product sterility testing. Statistical analysis and graphing were performed with commercial software. A total of 75/119 (63%) pediatric patients (median age 3 years) met study criteria. Only 16% of children required a CVC for ≥ 3 days. The CD34 collect rate and CD34-FE was stable over time whereas MNC-FE decreased after day 4 in 80% of patients. CD34-FE and MNC-FE showed inter- and intra-patient variability over time and appeared sensitive to plerixafor administration. Femoral CVC showed fewer flow-related AE compared to thoracic CVC, especially in pediatric patients (6.7% vs. 37%, P = 0.0005; OR = 0.12 (95%CI: 0.03-0.45). CVC removal was uneventful in 73/75 (97%) patients with hemostasis achieved after 20-30 min of pressure. In a 10-year period, there were no instances of product contamination associated with femoral CVC colonization. Femoral CVC are safe and effective for A-HPCC in young pediatric patients. Femoral CVC performance was maintained over several days with few flow-related alarms when compared to thoracic CVCs. © 2017 Wiley Periodicals, Inc.

  13. SAFETY

    CERN Multimedia

    Niels Dupont

    2013-01-01

    CERN Safety rules and Radiation Protection at CMS The CERN Safety rules are defined by the Occupational Health & Safety and Environmental Protection Unit (HSE Unit), CERN’s institutional authority and central Safety organ attached to the Director General. In particular the Radiation Protection group (DGS-RP1) ensures that personnel on the CERN sites and the public are protected from potentially harmful effects of ionising radiation linked to CERN activities. The RP Group fulfils its mandate in collaboration with the CERN departments owning or operating sources of ionising radiation and having the responsibility for Radiation Safety of these sources. The specific responsibilities concerning "Radiation Safety" and "Radiation Protection" are delegated as follows: Radiation Safety is the responsibility of every CERN Department owning radiation sources or using radiation sources put at its disposition. These Departments are in charge of implementing the requi...

  14. Reliability assurance for regulation of advanced reactors

    Energy Technology Data Exchange (ETDEWEB)

    Fullwood, R.; Lofaro, R.; Samanta, P.

    1991-12-31

    The advanced nuclear power plants must achieve higher levels of safety than the first generation of plants. Showing that this is indeed true provides new challenges to reliability and risk assessment methods in the analysis of the designs employing passive and semi-passive protection. Reliability assurance of the advanced reactor systems is important for determining the safety of the design and for determining the plant operability. Safety is the primary concern, but operability is considered indicative of good and safe operation. This paper discusses several concerns for reliability assurance of the advanced design encompassing reliability determination, level of detail required in advanced reactor submittals, data for reliability assurance, systems interactions and common cause effects, passive component reliability, PRA-based configuration control system, and inspection, training, maintenance and test requirements. Suggested approaches are provided for addressing each of these topics.

  15. 75 FR 28619 - Meeting of the Advisory Committee on Blood Safety and Availability

    Science.gov (United States)

    2010-05-21

    ... availability of the blood supply and blood products, (2) broad public health, ethical and legal issues related... subgroups, including those whose sex partners have risk behavior(s) associated with a higher prevalence of...

  16. [Quality assurance in human genetic testing].

    Science.gov (United States)

    Stuhrmann-Spangenberg, Manfred

    2015-02-01

    Advances in technical developments of genetic diagnostics for more than 50 years, as well as the fact that human genetic testing is usually performed only once in a lifetime, with additional impact for blood relatives, are determining the extraordinary importance of quality assurance in human genetic testing. Abidance of laws, directives, and guidelines plays a major role. This article aims to present the major laws, directives, and guidelines with respect to quality assurance of human genetic testing, paying careful attention to internal and external quality assurance. The information on quality assurance of human genetic testing was obtained through a web-based search of the web pages that are referred to in this article. Further information was retrieved from publications in the German Society of Human Genetics and through a PubMed-search using term quality + assurance + genetic + diagnostics. The most important laws, directives, and guidelines for quality assurance of human genetic testing are the gene diagnostics law (GenDG), the directive of the Federal Medical Council for quality control of clinical laboratory analysis (RiliBÄK), and the S2K guideline for human genetic diagnostics and counselling. In addition, voluntary accreditation under DIN EN ISO 15189:2013 offers a most recommended contribution towards quality assurance of human genetic testing. Legal restraints on quality assurance of human genetic testing as mentioned in § 5 GenDG are fulfilled once RiliBÄK requirements are followed.

  17. Blood

    Science.gov (United States)

    ... anemia. Iron deficiency anemia is the most common type of anemia and can affect people who have a diet ... 2015 More on this topic for: Teens Blood Types Donating Blood Blood Transfusions Anemia Sickle Cell Disease Hemophilia When Cancer Keeps You ...

  18. Safety testing of needle free, jet injection devices to detect contamination with blood and other tissue fluids.

    Science.gov (United States)

    Sweat, J M; Abdy, M; Weniger, B G; Harrington, R; Coyle, B; Abuknesha, R A; Gibbs, E P

    2000-01-01

    Needle free jet injection guns have been used extensively in both veterinary and human health to deliver both vaccine and drugs, but in recent years, concerns have mounted for their potential to transmit blood borne disease agents among consecutive vaccinates. A Ped-O-Jet type jet injection device was used to deliver serial subcutaneous injections of 0.5 mL saline (as a surrogate for vaccine) into calves and pigs, with intervening ejectates collected in vials to represent what the next vaccinate would have received. An enzyme linked immunosorbant assay was developed to detect species specific albumin as a marker for blood, using calibration standards from known dilutions of bovine or porcine blood. Assay sensitivity of 20 pL/mL corresponded to the estimated minimal chimpanzee infectious dose of 10 pL for hepatitis B virus. The methodology and available results for evaluating the safety of jet injector devices are reported.

  19. Rebuilding a safety culture

    Science.gov (United States)

    Rodney, George A.

    1991-01-01

    The development of a culture of safety and NASA since the Challenger accident is reviewed. The technical elements of the strengthened NASA safety program are described, including problem reporting, risk/assessment/risk management, operational safety, and safety assurance are addressed. Future directions in the development of safety are considered.

  20. Work plan, health and safety plan, and quality assurance project plan for hazardous waste removal at the CTF K-1654B underground collection tank

    Energy Technology Data Exchange (ETDEWEB)

    Panter, M.S.; Burman, S.N.; Landguth, D.C.; Uziel, M.S.

    1991-10-01

    The Central Training Facility (CTF), located on Bear Creek Road approximately two miles south of the K-25 Site, is utilized for training security personnel at Martin Marietta Energy Systems, Inc., Oak Ridge, Tennessee. At the request of the CTF staff, this plan has been developed for the removal of the waste contents in the facility's 500-gal septic tank and associated distribution box. The septic tank and distribution box were historically located beneath the K-1654B trailer and adjacent to the K-1654A Indoor Firing Range. Recently, however, the K-1654B trailer was removed to accommodate the objectives of this work plan as well as future construction activities planned at CTF. The purpose of this plan is to develop and assign responsibilities, establish personnel protection requirements and mandatory safety procedures, and provide for contingencies that may arise while operations are being conducted by ORNL/MAD at the CTF K-1654B underground collection tank site. This document addresses requirements of 29 CFR 1910.120, Final Rule, with respect to aspects of health and safety applicable to an underground collection tank waste removal.

  1. Work plan, health and safety plan, and quality assurance project plan for hazardous waste removal at the CTF K-1654B underground collection tank

    Energy Technology Data Exchange (ETDEWEB)

    Panter, M.S.; Burman, S.N.; Landguth, D.C.; Uziel, M.S.

    1991-10-01

    The Central Training Facility (CTF), located on Bear Creek Road approximately two miles south of the K-25 Site, is utilized for training security personnel at Martin Marietta Energy Systems, Inc., Oak Ridge, Tennessee. At the request of the CTF staff, this plan has been developed for the removal of the waste contents in the facility`s 500-gal septic tank and associated distribution box. The septic tank and distribution box were historically located beneath the K-1654B trailer and adjacent to the K-1654A Indoor Firing Range. Recently, however, the K-1654B trailer was removed to accommodate the objectives of this work plan as well as future construction activities planned at CTF. The purpose of this plan is to develop and assign responsibilities, establish personnel protection requirements and mandatory safety procedures, and provide for contingencies that may arise while operations are being conducted by ORNL/MAD at the CTF K-1654B underground collection tank site. This document addresses requirements of 29 CFR 1910.120, Final Rule, with respect to aspects of health and safety applicable to an underground collection tank waste removal.

  2. Quality assurance and marketing.

    Science.gov (United States)

    Demby, N A

    1985-07-01

    Although considerable efforts have been directed toward the development and utilization of marketing strategies for dental practices, little if any information exists in the specific area of the role quality assurance may play in marketing dental services. This article describes and analyzes the current relationship between quality assurance and marketing, given the complex array of factors on the horizon that may affect how dentistry is organized and delivered. It must become the role of the profession to see that the alliance between marketing and quality assurance continues and is utilized to assure the quality of care provided and accountability to the public.

  3. BLOOD

    African Journals Online (AJOL)

    benefit (altruism). '35 An individual who gives blood in replacement for that which has been given to his relation is referred to as family replacement donor. '2 But when a person donates blood for the purpose of transfusing a. defined patient, such a person is referred to as. AHMED S. G. AND HASSAN A. W. a directed donor.

  4. Introduction of a closed-system cell processor for red blood cell washing: postimplementation monitoring of safety and efficacy.

    Science.gov (United States)

    Acker, Jason P; Hansen, Adele L; Yi, Qi-Long; Sondi, Nayana; Cserti-Gazdewich, Christine; Pendergrast, Jacob; Hannach, Barbara

    2016-01-01

    After introduction of a closed-system cell processor, the effect of this product change on safety, efficacy, and utilization of washed red blood cells (RBCs) was assessed. This study was a pre-/postimplementation observational study. Efficacy data were collected from sequentially transfused washed RBCs received as prophylactic therapy by β-thalassemia patients during a 3-month period before and after implementation of the Haemonetics ACP 215 closed-system processor. Before implementation, an open system (TerumoBCT COBE 2991) was used to wash RBCs. The primary endpoint for efficacy was a change in hemoglobin (Hb) concentration corrected for the duration between transfusions. The primary endpoint for safety was the frequency of adverse transfusion reactions (ATRs) in all washed RBCs provided by Canadian Blood Services to the transfusion service for 12 months before and after implementation. Data were analyzed from more than 300 RBCs transfused to 31 recipients before implementation and 29 recipients after implementation. The number of units transfused per episode reduced significantly after implementation, from a mean of 3.5 units to a mean of 3.1 units (p processor. The ACP 215 allowed for an extended expiry time, improving inventory management and overall utilization of washed RBCs. Transfusion of fewer RBCs per episode reduced exposure of recipients to allogeneic blood products while maintaining efficacy. © 2015 AABB.

  5. Hepatitis E and blood donation safety in selected European countries: a shift to screening?

    Science.gov (United States)

    Domanović, Dragoslav; Tedder, Richard; Blümel, Johannes; Zaaijer, Hans; Gallian, Pierre; Niederhauser, Christoph; Sauleda Oliveras, Silvia; O'Riordan, Joan; Boland, Fiona; Harritshøj, Lene; Nascimento, Maria São José; Ciccaglione, Anna Rita; Politis, Constatina; Adlhoch, Cornelia; Flan, Benoit; Oualikene-Gonin, Wahiba; Rautmann, Guy; Strengers, Paul; Hewitt, Patricia

    2017-04-20

    The public health implications of hepatitis E virus (HEV) in Europe have changed due to increasing numbers of hepatitis E cases and recent reports of chronic, persistent HEV infections associated with progression to cirrhosis in immunosuppressed patients. The main infectious risk for such immunosuppressed patients is exposure to undercooked infected pork products and blood transfusion. We summarised the epidemiology of HEV infections among blood donors and also outlined any strategies to prevent transfusion-transmitted HEV, in 11 European countries. In response to the threat posed by HEV and related public and political concerns, most of the observed countries determined seroprevalence of HEV in donors and presence of HEV RNA in blood donations. France, Germany, Spain and the United Kingdom (UK) reported cases of transfusion-transmitted HEV. Ireland and the UK have already implemented HEV RNA screening of blood donations; the Netherlands will start in 2017. Germany and France perform screening for HEV RNA in several blood establishments or plasma donations intended for use in high-risk patients respectively and, with Switzerland, are considering implementing selective or universal screening nationwide. In Greece, Portugal, Italy and Spain, the blood authorities are evaluating the situation. Denmark decided not to implement the HEV screening of blood donations. This article is copyright of The Authors, 2017.

  6. Prehospital blood transfusions in pediatric trauma and nontrauma patients: a single-center review of safety and outcomes.

    Science.gov (United States)

    Fahy, Aodhnait S; Thiels, Cornelius A; Polites, Stephanie F; Parker, Maile; Ishitani, Michael B; Moir, Christopher R; Berns, Kathleen; Stubbs, James R; Jenkins, Donald H; Zietlow, Scott P; Zielinski, Martin D

    2017-07-01

    Prehospital transfusions are a novel yet increasingly accepted intervention in the adult population as part of remote damage control resuscitation, but prehospital transfusions remain controversial in children. Our purpose was to review our pediatric prehospital transfusion experience over 12 years to describe the safety of prehospital transfusion in appropriately triaged trauma and nontrauma patients. Children (prehospital transfusions of blood products were safe in this small group of appropriately triaged pediatric patients. Further studies are needed to determine if outcomes are improved and to devise a rigorous protocol for this prehospital intervention for critically ill pediatric patients.

  7. Development and implementation challenges of a quality assured HIV infant diagnosis program in Nigeria using dried blood spots and DNA polymerase chain reaction.

    Science.gov (United States)

    Audu, Rosemary; Onwuamah, Chika; Salu, Olumuyiwa; Okwuraiwe, Azuka; Ou, Chin-Yih; Bolu, Omotayo; Bond, Kyle B; Diallo, Karidia; Lu, Lydia; Jelpe, Tapdiyel; Okoye, McPaul; Ngige, Evelyn; Vertefeuille, John

    2015-04-01

    Nigeria has one of the highest HIV burdens as well as mother-to-infant transmission rates in the world. A pilot program using polymerase chain reaction (PCR)-based testing of dried blood spot (DBS) specimens was implemented to enable early identification of HIV-infected infants and timely referral and linkage to care. From February 2007 to October 2008, whole blood was collected by finger prick to prepare DBS from infants tested using the Roche Amplicor HIV-1 DNA Test, v1.5. To monitor laboratory testing quality, all of the PCR-positive and 10% of the PCR-negative DBS were retested by the same method at another reference laboratory. Three hundred and sixty-five randomly selected infants were screened using HIV rapid tests (RT) according to the national algorithm and RT-negative and PCR-positive specimens were also tested using Genscreen enzyme-linked immunosorbent assay (EIA) (Bio-Rad, France). The turnaround time (TAT) from sample collection, testing, and dispatching of results from each health facility was monitored. A total of 1,273 infants with a median age of 12.6 weeks (1 day to 71.6 weeks) participated in the program and 280 (22.0%) were PCR positive. HIV transmission levels varied greatly in the different health facilities ranging from 7.1% to 38.4%. Infants aged 48 to 72 weeks had the highest level of PCR positivity (41.1%). All PCR-positive specimens were confirmed by retesting. The mean turnaround time from DBS collection to returning of the laboratory result to the health facilities was 25 days. Three infants were found to be HIV antibody negative by rapid tests but were positive by both PCR and the fourth generation EIA. The DBS-based PCR program accurately identified all of the HIV-infected infants. However, many programmatic challenges related to the laboratory and TAT were identified.

  8. Insight into "Calculated Risk": An Application to the Prioritization of Emerging Infectious Diseases for Blood Transfusion Safety.

    Science.gov (United States)

    Neslo, R E J; Oei, W; Janssen, M P

    2017-09-01

    Increasing identification of transmissions of emerging infectious diseases (EIDs) by blood transfusion raised the question which of these EIDs poses the highest risk to blood safety. For a number of the EIDs that are perceived to be a threat to blood safety, evidence on actual disease or transmission characteristics is lacking, which might render measures against such EIDs disputable. On the other hand, the fact that we call them "emerging" implies almost by definition that we are uncertain about at least some of their characteristics. So what is the relative importance of various disease and transmission characteristics, and how are these influenced by the degree of uncertainty associated with their actual values? We identified the likelihood of transmission by blood transfusion, the presence of an asymptomatic phase of infection, prevalence of infection, and the disease impact as the main characteristics of the perceived risk of disease transmission by blood transfusion. A group of experts in the field of infectious diseases and blood transfusion ranked sets of (hypothetical) diseases with varying degrees of uncertainty associated with their disease characteristics, and used probabilistic inversion to obtain probability distributions for the weight of each of these risk characteristics. These distribution weights can be used to rank both existing and newly emerging infectious diseases with (partially) known characteristics. Analyses show that in case there is a lack of data concerning disease characteristics, it is the uncertainty concerning the asymptomatic phase and the disease impact that are the most important drivers of the perceived risk. On the other hand, if disease characteristics are well established, it is the prevalence of infection and the transmissibility of the disease by blood transfusion that will drive the perceived risk. The risk prioritization model derived provides an easy to obtain and rational expert assessment of the relative importance of

  9. Solute Carriers in the Blood-Brain Barier: Safety in Abundance.

    Science.gov (United States)

    Nałęcz, Katarzyna A

    2017-03-01

    Blood-brain barrier formed by brain capillary endothelial cells, being in contact with astrocytes endfeet and pericytes, separates extracellular fluid from plasma. Supply of necessary nutrients and removal of certain metabolites takes place due to the activity of transporting proteins from ABC (ATP binding cassette) and SLC (solute carrier) superfamilies. This review is focused on the SLC families involved in transport though the blood-brain barrier of energetic substrates (glucose, monocarboxylates, creatine), amino acids, neurotransmitters and their precursors, as well as organic ions. Members of SLC1, SLC2, SLC3/SLC7, SLC5, SLC6, SLC16, SLC22, SLC38, SLC44, SLC47 and SLCO (SLC21), whose presence in the blood-brain barriers has been demonstrated are characterized with a special emphasis put on polarity of transporters localization in a luminal (blood side) versus an abluminal (brain side) membrane.

  10. High assurance services computing

    CERN Document Server

    2009-01-01

    Covers service-oriented technologies in different domains including high assurance systemsAssists software engineers from industry and government laboratories who develop mission-critical software, and simultaneously provides academia with a practitioner's outlook on the problems of high-assurance software development

  11. [Design of a Hazard Analysis and Critical Control Points (HACCP) plan to assure the safety of a bologna product produced by a meat processing plant].

    Science.gov (United States)

    Bou Rached, Lizet; Ascanio, Norelis; Hernández, Pilar

    2004-03-01

    The Hazard Analysis and Critical Control Point (HACCP) is a systematic integral program used to identify and estimate the hazards (microbiological, chemical and physical) and the risks generated during the primary production, processing, storage, distribution, expense and consumption of foods. To establish a program of HACCP has advantages, being some of them: to emphasize more in the prevention than in the detection, to diminish the costs, to minimize the risk of manufacturing faulty products, to allow bigger trust to the management, to strengthen the national and international competitiveness, among others. The present work is a proposal based on the design of an HACCP program to guarantee the safety of the Bologna Special Type elaborated by a meat products industry, through the determination of hazards (microbiological, chemical or physical), the identification of critical control points (CCP), the establishment of critical limits, plan corrective actions and the establishment of documentation and verification procedures. The used methodology was based in the application of the seven basic principles settled down by the Codex Alimentarius, obtaining the design of this program. In view of the fact that recently the meat products are linked with pathogens like E. coli O157:H7 and Listeria monocytogenes, these were contemplated as microbiological hazard for the establishment of the HACCP plan whose application will guarantee the obtaining of a safe product.

  12. Health economics and outcomes methods in risk-based decision-making for blood safety

    NARCIS (Netherlands)

    Custer, Brian; Janssen, Mart P.

    2015-01-01

    Analytical methods appropriate for health economic assessments of transfusion safety interventions have not previously been described in ways that facilitate their use. Within the context of risk-based decision-making (RBDM), health economics can be important for optimizing decisions among competing

  13. 78 FR 66006 - Meeting of the Advisory Committee on Blood and Tissue Safety and Availability

    Science.gov (United States)

    2013-11-04

    ..., and (3) the implications for safety and availability of various economic factors affecting product... session should to contact the designated Federal official to register prior to close of business on... the close of business on December 2, 2013. It is also requested that any member of the public who...

  14. 76 FR 26300 - Meeting of the Advisory Committee on Blood Safety and Availability

    Science.gov (United States)

    2011-05-06

    ... transplantation will be considered as it relates to safety. Concerns for a globally consistent coding system for... time (limited to 5 minutes) and registration must be prior to close of business on June 3, 2011. If it... the Executive Secretary prior to the close of business on June 6, 2011. Electronic comments must...

  15. Half a decade of mini-pool nucleic acid testing: Cost-effective way for improving blood safety in India

    Directory of Open Access Journals (Sweden)

    Shivaram Chandrashekar

    2014-01-01

    Full Text Available Background and Objectives: It is well established that Nucleic acid testing (NAT reduces window phase of transfusion transmissible infections (TTI and helps improve blood safety. NAT testing can be done individually or in pools. The objectives of this study were to determine the utility, feasibility and cost effectiveness of an in-house minipool-NAT(MP-NAT. Materials and Methods: Blood donors were screened by history, tested by ELISA and sero-negative samples were subjected to an in-house NAT by using reverse transcriptase-polymerase chain reaction (RT-PCR. Testing was done in mini-pools of size eight (8. Positive pools were repeated with individual samples. Results: During the study period of Oct 2005-Sept 2010 (5 years all blood donors (n=53729 were screened by ELISA. Of which 469 (0.87% were positive for HIV-1, HBV or HCV. Sero-negative samples (n=53260 were screened by in-house MP-NAT. HIV-NAT yield was 1/53260 (n=1 and HBV NAT yield (n=2 was 1/26630. Conclusion: NAT yield was lower than other India studies possibly due to the lower sero-reactivity amongst our donors. Nevertheless it intercepted 9 lives including the components prepared. The in-house assay met our objective of improving blood safety at nominal cost and showed that it is feasible to set up small molecular biology units in medium-large sized blood banks and deliver blood within 24-48 hours. The utility of NAT (NAT yield will vary based on the donor population, the type of serological test used, the nature of kit employed and the sensitivity of NAT test used. The limitations of our in-house MP-NAT consisted of stringent sample preparation requirements, with labor and time involved. The benefits of our MP-NAT were that it acted as a second level of check for ELISA tests, was relatively inexpensive compared to ID-NAT and did not need sophisticated equipment.

  16. Quality assurance for gamma knives

    Energy Technology Data Exchange (ETDEWEB)

    Jones, E.D.; Banks, W.W.; Fischer, L.E. [Lawrence Livermore National Lab., CA (United States)

    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, 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.

  17. Safety Validation of Repeated Blood-Brain Barrier Disruption Using Focused Ultrasound

    NARCIS (Netherlands)

    Kobus, T.; Vykhodtseva, N.; Pilatou, M.; Zhang, Y.; McDannold, N.

    2016-01-01

    The purpose of this study was to investigate the effects on the brain of multiple sessions of blood-brain barrier (BBB) disruption using focused ultrasound (FUS) in combination with micro-bubbles over a range of acoustic exposure levels. Six weekly sessions of FUS, using acoustical pressures between

  18. Software quality assurance handbook

    Energy Technology Data Exchange (ETDEWEB)

    1990-09-01

    There are two important reasons for Software Quality Assurance (SQA) at Allied-Signal Inc., Kansas City Division (KCD): First, the benefits from SQA make good business sense. Second, the Department of Energy has requested SQA. This handbook is one of the first steps in a plant-wide implementation of Software Quality Assurance at KCD. The handbook has two main purposes. The first is to provide information that you will need to perform software quality assurance activities. The second is to provide a common thread to unify the approach to SQA at KCD. 2 figs.

  19. Status of blood banking and the blood supply in Afghanistan.

    Science.gov (United States)

    Ayyoubi, M Tayyeb; Konstenius, Terri; McCullough, Jeffrey C; Eastlund, Ted; Clay, Mary; Bowman, Robert; Rahmani, Ahmad Masoud; Riley, William; McCullough, Jeffrey

    2010-03-01

    As a result of more than 20 years of war in Afghanistan, its blood supply system has been damaged. We carried out an assessment of that blood supply system to determine the type and extent of assistance needed to increase blood availability and safety. An assessment tool was developed, daily activities in Afghanistan were observed, and key personnel were interviewed. Because there was no donor recruitment organization, most blood was obtained by the family replacement system. There was an inadequate supply of stored blood, which led to use of blood before screening test results for transfusion-transmitted disease were complete. Whole blood was provided but blood components were not produced. Blood was tested intermittently for human immunodeficiency virus Types 1 and 2, hepatitis B surface antigen, hepatitis C virus, and syphilis using agglutination-based screening methods. A dedicated staff is in place but to strengthen the blood supply system in Afghanistan, it will be important to address infrastructure and facilities, organization, standard operating methods, supplies and equipment, training, quality assurance, and transfusion medicine education.

  20. Model Based Mission Assurance: Emerging Opportunities for Robotic Systems

    Science.gov (United States)

    Evans, John W.; DiVenti, Tony

    2016-01-01

    The emergence of Model Based Systems Engineering (MBSE) in a Model Based Engineering framework has created new opportunities to improve effectiveness and efficiencies across the assurance functions. The MBSE environment supports not only system architecture development, but provides for support of Systems Safety, Reliability and Risk Analysis concurrently in the same framework. Linking to detailed design will further improve assurance capabilities to support failures avoidance and mitigation in flight systems. This also is leading new assurance functions including model assurance and management of uncertainty in the modeling environment. Further, the assurance cases, a structured hierarchal argument or model, are emerging as a basis for supporting a comprehensive viewpoint in which to support Model Based Mission Assurance (MBMA).

  1. EMC Compliance Assurance Monitoring

    Science.gov (United States)

    The Compliance Assurance Monitoring, or CAM, rule is designed to satisfy the requirements for monitoring and compliance certification in the Part 70 operating permits program and Title VII of the 1990 Clean Air Act Amendments

  2. RAVEN Quality Assurance Activities

    Energy Technology Data Exchange (ETDEWEB)

    Cogliati, Joshua Joseph [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2015-09-01

    This report discusses the quality assurance activities needed to raise the Quality Level of Risk Analysis in a Virtual Environment (RAVEN) from Quality Level 3 to Quality Level 2. This report also describes the general RAVEN quality assurance activities. For improving the quality, reviews of code changes have been instituted, more parts of testing have been automated, and improved packaging has been created. For upgrading the quality level, requirements have been created and the workflow has been improved.

  3. Benchmarking Software Assurance Implementation

    Science.gov (United States)

    2011-05-18

    product The chicken#. (a.k.a. Process Focused Assessment ) – Management Systems ( ISO 9001, ISO 27001 , ISO 2000) – Capability Maturity Models (CMMI...Benchmarking Software Assurance Implementation Michele Moss SSTC Conference May 18, 2011 Report Documentation Page Form ApprovedOMB No. 0704-0188...00-00-2011 4. TITLE AND SUBTITLE Benchmarking Software Assurance Implementation 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER

  4. Effectiveness and safety of nicardipine and labetalol infusion for blood pressure management in patients with intracerebral and subarachnoid hemorrhage.

    Science.gov (United States)

    Ortega-Gutierrez, Santiago; Thomas, Jiz; Reccius, Andres; Agarwal, Sachin; Lantigua, Hector; Li, Min; Carpenter, Amanda M; Mayer, Stephan A; Schmidt, J Michael; Lee, Kiwon; Claassen, Jan; Badjatia, Neeraj; Lesch, Christine

    2013-02-01

    Nicardipine and labetalol are two commonly used antihypertensives for treating elevated blood pressures in the setting of intracerebral hemorrhage (ICH) and subarachnoid hemorrhage (SAH). There are no studies comparing these two agents as continuous infusions. A retrospective chart review was conducted of patients admitted between November 2009 and January 2011 with ICH and SAH to compare effectiveness and safety between both agents. Percent time spent at goal was set as the primary outcome. The secondary outcomes included blood pressure variability, time to goal, incidence of bradycardia, tachycardia, and hypotension. A total of 81 patients were available for analysis, 10 initiated on labetalol (LAB), 57 on nicardipine (NIC), and 14 required the combination of these agents (COMB) to reach goal. We found no difference between NIC, LAB, and the COMB groups in the median percent time at goal [88 % (61-98); 93 % (51-99); 66 % (25-95), (p = NS)]. Median percentage of blood pressure variability, hypotension, and bradycardia were also comparable between groups, however, more tachycardia was observed in the COMB group versus both LAB and NIC groups (45 vs. 0 vs. 3 %; p < 0.001). Mean time to goal SBP in 24 patients who had BP readings available at 1st h of initiation was 32 ± 34 min in the NIC group and 53 ± 42 min in the LAB group (p = 0.03). Both agents appear equally effective and safe for blood pressure control in SAH and ICH during the initial admission hours. A prospective study is needed to validate these findings.

  5. SAFETY

    CERN Multimedia

    C. Schaefer and N. Dupont

    2013-01-01

      “Safety is the highest priority”: this statement from CERN is endorsed by the CMS management. An interpretation of this statement may bring you to the conclusion that you should stop working in order to avoid risks. If the safety is the priority, work is not! This would be a misunderstanding and misinterpretation. One should understand that “working safely” or “operating safely” is the priority at CERN. CERN personnel are exposed to different hazards on many levels on a daily basis. However, risk analyses and assessments are done in order to limit the number and the gravity of accidents. For example, this process takes place each time you cross the road. The hazard is the moving vehicle, the stake is you and the risk might be the risk of collision between both. The same principle has to be applied during our daily work. In particular, keeping in mind the general principles of prevention defined in the late 1980s. These principles wer...

  6. SAFETY

    CERN Document Server

    M. Plagge, C. Schaefer and N. Dupont

    2013-01-01

    Fire Safety – Essential for a particle detector The CMS detector is a marvel of high technology, one of the most precise particle measurement devices we have built until now. Of course it has to be protected from external and internal incidents like the ones that can occur from fires. Due to the fire load, the permanent availability of oxygen and the presence of various ignition sources mostly based on electricity this has to be addressed. Starting from the beam pipe towards the magnet coil, the detector is protected by flooding it with pure gaseous nitrogen during operation. The outer shell of CMS, namely the yoke and the muon chambers are then covered by an emergency inertion system also based on nitrogen. To ensure maximum fire safety, all materials used comply with the CERN regulations IS 23 and IS 41 with only a few exceptions. Every piece of the 30-tonne polyethylene shielding is high-density material, borated, boxed within steel and coated with intumescent (a paint that creates a thick co...

  7. The National Heart, Lung, and Blood Institute retrovirus epidemiology donor studies (Retrovirus Epidemiology Donor Study and Retrovirus Epidemiology Donor Study-II): twenty years of research to advance blood product safety and availability.

    Science.gov (United States)

    Kleinman, Steven; King, Melissa R; Busch, Michael P; Murphy, Edward L; Glynn, Simone A

    2012-10-01

    The Retrovirus Epidemiology Donor Study (REDS), conducted from 1989 to 2001, and the REDS-II, conducted from 2004 to 2012, were National Heart, Lung, and Blood Institute-funded, multicenter programs focused on improving blood safety and availability in the United States. The REDS-II also included international study sites in Brazil and China. The 3 major research domains of REDS/REDS-II have been infectious disease risk evaluation, blood donation availability, and blood donor characterization. Both programs have made significant contributions to transfusion medicine research methodology by the use of mathematical modeling, large-scale donor surveys, innovative methods of repository sample storage, and establishing an infrastructure that responded to potential emerging blood safety threats such as xenotropic murine leukemia virus-related virus. Blood safety studies have included protocols evaluating epidemiologic and/or laboratory aspects of human immunodeficiency virus, human T-lymphotropic virus 1/2, hepatitis C virus, hepatitis B virus, West Nile virus, cytomegalovirus, human herpesvirus 8, parvovirus B19, malaria, Creutzfeldt-Jakob disease, influenza, and Trypanosoma cruzi infections. Other analyses have characterized blood donor demographics, motivations to donate, factors influencing donor return, behavioral risk factors, donors' perception of the blood donation screening process, and aspects of donor deferral. In REDS-II, 2 large-scale blood donor protocols examined iron deficiency in donors and the prevalence of leukocyte antibodies. This review describes the major study results from over 150 peer-reviewed articles published by these 2 REDS programs. In 2011, a new 7-year program, the Recipient Epidemiology and Donor Evaluation Study-III, was launched. The Recipient Epidemiology and Donor Evaluation Study-III expands beyond donor-based research to include studies of blood transfusion recipients in the hospital setting and adds a third country, South Africa

  8. Hemovigilance in Massachusetts and the adoption of statewide hospital blood bank reporting using the National Healthcare Safety Network.

    Science.gov (United States)

    Cumming, Melissa; Osinski, Anthony; O'Hearn, Lynne; Waksmonski, Pamela; Herman, Michele; Gordon, Deborah; Griffiths, Elzbieta; Knox, Kim; McHale, Eileen; Quillen, Karen; Rios, Jorge; Pisciotto, Patricia; Uhl, Lynne; DeMaria, Alfred; Andrzejewski, Chester

    2017-02-01

    A collaboration that grew over time between local hemovigilance stakeholders and the Massachusetts Department of Public Health (MDPH) resulted in the change from a paper-based method of reporting adverse reactions and monthly transfusion activity for regulatory compliance purposes to statewide adoption of electronic reporting via the National Healthcare Safety Network (NHSN). The NHSN is a web-based surveillance system that offers the capacity to capture transfusion-related adverse events, incidents, and monthly transfusion statistics from participating facilities. Massachusetts' hospital blood banks share the data they enter into NHSN with the MDPH to satisfy reporting requirements. Users of the NHSN Hemovigilance Module adhere to specified data entry guidelines, resulting in data that are comparable and standardized. Keys to successful statewide adoption of this reporting method include the fostering of strong partnerships with local hemovigilance champions and experts, engagement of regulatory and epidemiology divisions at the state health department, the leveraging of existing relationships with hospital NHSN administrators, and the existence of a regulatory deadline for implementation. Although limitations exist, successful implementation of statewide use of the NHSN Hemovigilance Module for hospital blood bank reporting is possible. The result is standardized, actionable data at both the hospital and state level that can facilitate interfacility comparisons, benchmarking, and opportunities for practice improvement. © 2016 AABB.

  9. Blood Pressure Lowering and Safety Improvements With Liver Angiotensinogen Inhibition in Models of Hypertension and Kidney Injury.

    Science.gov (United States)

    Mullick, Adam E; Yeh, Steve T; Graham, Mark J; Engelhardt, Jeffery A; Prakash, Thazha P; Crooke, Rosanne M

    2017-09-01

    Uncontrolled hypertension is an important contributor to cardiovascular disease. Despite the armamentarium of antihypertensive treatments, there remains a need for novel agents effective in individuals who cannot reach acceptable blood pressure levels. Inhibitors targeting the renin-angiotensin-aldosterone system (RAAS) are widely used but may not optimally inhibit RAAS and demonstrate an acceptable safety profile. Experiments were conducted to characterize a series of AGT (angiotensinogen) antisense oligonucleotides (ASOs) and compare their efficacy and tolerability to traditional RAAS blockade. AGT ASOs which target multiple systemic sites of AGT versus an N-acetylgalactosamine-conjugated AGT ASO that targets the liver were compared with captopril and losartan. Spontaneously hypertensive rats fed an 8% NaCl diet, a model of malignant hypertension resistant to standard RAAS inhibitors, demonstrated robust and durable blood pressure reductions with AGT ASO treatments, which was not observed with standard RAAS blockade. Studies in rat models of acute kidney injury produced by salt deprivation revealed kidney injury with ASO treatment that reduced kidney-expressed AGT, but not in animals treated with the N-acetylgalactosamine AGT ASO despite comparable plasma AGT reductions. Administration of either captopril or losartan also produced acute kidney injury during salt deprivation. Thus, intrarenal RAAS derived from kidney AGT, and inhibited by the standard of care, contributes to the maintenance of renal function during severe RAAS challenge. Such improvements in efficacy and tolerability by a liver-selective AGT inhibitor could be desirable in individuals not at their blood pressure goal with existing RAAS blockade. © 2017 American Heart Association, Inc.

  10. Efficacy and safety of valsartan plus hydroclorothiazide for high blood pressure

    Science.gov (United States)

    Ruvolo, Antonio; Mercurio, Valentina; Fazio, Valeria; Carlomagno, Guido; Russo, Teresa; Affuso, Flora; Fazio, Serafino

    2010-01-01

    AIM: To evaluate efficacy and tolerability of the combination valsartan plus hydrochlorothiazide (160 mg and 25 mg daily, respectively) in young-middle aged males with high-normal blood pressure (BP) or first-degree arterial hypertension with evidence of target organ damage. METHODS: Twenty males with high-normal BP or first-degree hypertension associated with left ventricular concentric remodeling and/or increased aortic stiffness were enrolled. BP at rest and during exercise, and echocardiographic parameters of the left ventricle (LV), were evaluated at baseline and after 3 mo of treatment. The effects of treatment on aortic stiffness, metabolic parameters, renal and erectile function were also assessed. RESULTS: BP was significantly reduced by treatment both at rest (P < 0.001) and during exercise (P < 0.001), and 85% of patients achieved BP normalization (< 130/85 mmHg). Doppler echocardiography showed a significant reduction of LV mass (P < 0.005). LV hypertrophy was identified in 70% of subjects at baseline and in 5% after 3 mo of treatment. The ratio of early (E) to late (A) trans-mitral diastolic flow velocity increased, (P < 0.05), the relative wall thickness decreased (P < 0.05) and the left ventricular relaxation time shortened (P < 0.005). The left atrial diameter (P < 0.05) and the aortic diameter (P < 0.05) and stiffness (P < 0.005) also decreased. CONCLUSION: The full-dose combination of valsartan plus hydrochlorothiazide produced optimal BP control with regression of target organ damage, already after 3 mo, without relevant side effects. PMID:21160714

  11. The limits of sterility assurance.

    Science.gov (United States)

    von Woedtke, Thomas; Kramer, Axel

    2008-09-03

    Sterility means the absence of all viable microorganisms including viruses. At present, a sterility assurance level (SAL) of 10(-6) is generally accepted for pharmacopoeial sterilization procedures, i.e., a probability of not more than one viable microorganism in an amount of one million sterilised items of the final product. By extrapolating the reduction rates following extreme artificial initial contamination, a theoretical overall performance of the procedure of at least 12 lg increments (overkill conditions) is demanded to verify an SAL of 10(-6). By comparison, other recommendations for thermal sterilization procedures demand only evidence that the difference between the initial contamination and the number of test organisms at the end of the process amount to more than six orders of magnitude. However, a practical proof of the required level of sterility assurance of 10(-6) is not possible. Moreover, the attainability of this condition is fundamentally dubious, at least in non-thermal procedures. Thus, the question is discussed whether the undifferentiated adherence to the concept of sterility assurance on the basis of a single SAL of 10(-6) corresponds with the safety requirements in terms of patient or user safety, costs and energy efficiency. Therefore, in terms of practical considerations, a concept of tiered SALs is recommended, analogous to the comparable and well-established categorization into "High-level disinfection", "Intermediate-level disinfection" and "Low-level disinfection". The determination of such tiered SALs is geared both to the intended application of the sterilized goods, as well as to the characteristics of the products and the corresponding treatment options.In the case of aseptic preparation, filling and production procedures, a mean contamination probability of 10(-3) is assumed. In automated processes, lower contamination rates can be realized. In the case of the production of re-usable medical devices, a reduction of at least 2

  12. AVLIS Production Plant Preliminary Quality Assurance Plan and Assessment

    Energy Technology Data Exchange (ETDEWEB)

    1984-11-15

    This preliminary Quality Assurance Plan and Assessment establishes the Quality Assurance requirements for the AVLIS Production Plant Project. The Quality Assurance Plan defines the management approach, organization, interfaces, and controls that will be used in order to provide adequate confidence that the AVLIS Production Plant design, procurement, construction, fabrication, installation, start-up, and operation are accomplished within established goals and objectives. The Quality Assurance Program defined in this document includes a system for assessing those elements of the project whose failure would have a significant impact on safety, environment, schedule, cost, or overall plant objectives. As elements of the project are assessed, classifications are provided to establish and assure that special actions are defined which will eliminate or reduce the probability of occurrence or control the consequences of failure. 8 figures, 18 tables.

  13. Quality Assurance Program Description

    Energy Technology Data Exchange (ETDEWEB)

    Halford, Vaughn Edward [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Ryder, Ann Marie [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2017-07-01

    Effective May 1, 2017, led by a new executive leadership team, Sandia began operating within a new organizational structure. National Technology and Engineering Solutions of Sandia (Sandia’s) Quality Assurance Program (QAP) was established to assign responsibilities and authorities, define workflow policies and requirements, and provide for the performance and assessment of work.

  14. Medicine in Ancient Assur

    DEFF Research Database (Denmark)

    Arbøll, Troels Pank

    This dissertation is a microhistorical study of a single individual named Kiṣir-Aššur who practiced medicine in the ancient city of Assur (modern northern Iraq) in the 7th century BCE. The study provides the first detailed analysis of one healer’s education and practice in ancient Mesopotamia...

  15. Read Code Quality Assurance

    Science.gov (United States)

    Schulz, Erich; Barrett, James W.; Price, Colin

    1998-01-01

    As controlled clinical vocabularies assume an increasing role in modern clinical information systems, so the issue of their quality demands greater attention. In order to meet the resulting stringent criteria for completeness and correctness, a quality assurance system comprising a database of more than 500 rules is being developed and applied to the Read Thesaurus. The authors discuss the requirement to apply quality assurance processes to their dynamic editing database in order to ensure the quality of exported products. Sources of errors include human, hardware, and software factors as well as new rules and transactions. The overall quality strategy includes prevention, detection, and correction of errors. The quality assurance process encompasses simple data specification, internal consistency, inspection procedures and, eventually, field testing. The quality assurance system is driven by a small number of tables and UNIX scripts, with “business rules” declared explicitly as Structured Query Language (SQL) statements. Concurrent authorship, client-server technology, and an initial failure to implement robust transaction control have all provided valuable lessons. The feedback loop for error management needs to be short. PMID:9670131

  16. Quality assurance in Zambia.

    Science.gov (United States)

    Reinke, J; Tembo, J; Limbambala, M F; Chikuta, S; Zaenger, D

    1996-01-01

    Primary health care reforms in Zambia have focused on the themes of effective leadership, community involvement, and improved service quality. To achieve these goals, the Ministry of Health's structure has been decentralized and a Health Reforms Implementation Team (including a Quality Assurance Unit) has been established. This unit collaborates with government and private sector organizations and professional groups in areas such as strategic planning, problem solving, facility assessment, standards setting, and indicator development. Each province has two linkage facilitators who provide district-level training and support to quality assurance coaches. As part of this process, staff at Nanga Rural Health Center in Mazabuka District selected patient privacy as a priority quality assurance issue and established an enclosed area for patient interviews. This measure facilitated increased patient disclosure about and comfort with discussing sensitive medical issues such as family planning and sexually transmitted diseases. Next, the health center staff examined the problem of pharmaceutical shortages, and user fees were identified as a means of purchasing commonly unavailable drugs. At the Magoye Rural Health Center, quality assurance assessment led to the consolidation of services such as infant weighing and immunization at the same location, thereby significantly increasing service utilization.

  17. Providing Continuous Assurance

    NARCIS (Netherlands)

    Kocken, Jonne; Hulstijn, Joris

    2017-01-01

    It has been claimed that continuous assurance can be attained by combining continuous monitoring by management, with continuous auditing of data streams and the effectiveness of internal controls by an external auditor. However, we find that in existing literature the final step to continuous

  18. General safety considerations

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-09-01

    This document presents the full filling of the Brazilian obligations under the Convention on Nuclear Safety. The Chapter 4 of the document contains some details about the priority to safety, financial and human resources, human factors, quality assurance, safety assessment and verification, radiation protection and emergency preparedness.

  19. The safety of early fresh, whole blood transfusion among severely battle injured at US Marine Corps forward surgical care facilities in Afghanistan.

    Science.gov (United States)

    Auten, Jonathan D; Lunceford, Nicole L; Horton, Jaime L; Galarneau, Mike R; Galindo, Roger M; Shepps, Craig D; Zieber, Tara J; Dewing, Chris B

    2015-11-01

    In Afghanistan, care of the acutely injured trauma patient commonly occurred in facilities with limited blood banking capabilities. Apheresis platelets were often not available. Component therapy consisted of 1:1 packed red blood cells and fresh frozen plasma. Fresh, whole blood transfusion often augmented therapy in the severely injured patient. This study analyzed the safety of fresh, whole blood use in a resource-limited setting. A retrospective analysis was performed on a prospectively collected data set of US battle injuries presenting to three US Marine Corps (USMC) expeditionary surgical care facilities in Helmand Province, Afghanistan, between January 2010 and July 2012. Included in the review were patients with Injury Severity Scores (ISSs) of 15 or higher receiving blood transfusions. Univariate analyses were performed, followed by multivariable logistic regression to describe the relationship between the treatment group and posttreatment complications such as trauma-induced coagulopathy, infection, mortality, venous thromboembolism, and transfusion reaction. Propensity scores were calculated and included in multivariable models to adjust for potential bias in treatment selection. A total of 61 patients were identified; all were male marines with a mean (SD) age of 23.5 (3.6) years. The group receiving fresh, whole blood was noted to have higher ISSs and lower blood pressure, pH, and base deficits on arrival. Traumatic coagulopathy was significantly less common in the group receiving fresh, whole blood (odds ratio, 0.01; 95% confidence interval, 0.00-0.18). Multivariable models found no other significant differences between the treatment groups. The early use of fresh, whole blood in a resource-limited setting seems to confer a benefit in reducing traumatic coagulopathy. This study's small sample size precludes further statement on the overall safety of fresh, whole blood use. Therapy study, level IV.

  20. Creating Quality Assurance and International Transparency for Quality Assurance Agencies

    DEFF Research Database (Denmark)

    Kristoffersen, Dorte; Lindeberg, Tobias

    2004-01-01

    The paper presents the experiences gained in the pilot project on mutual recognition conducted by the quality assurance agencies in the Nordic countries and the future perspective for international quality assurance of national quality assurance agencies. The background of the project was the nee...

  1. Survey of Software Assurance Techniques for Highly Reliable Systems

    Science.gov (United States)

    Nelson, Stacy

    2004-01-01

    This document provides a survey of software assurance techniques for highly reliable systems including a discussion of relevant safety standards for various industries in the United States and Europe, as well as examples of methods used during software development projects. It contains one section for each industry surveyed: Aerospace, Defense, Nuclear Power, Medical Devices and Transportation. Each section provides an overview of applicable standards and examples of a mission or software development project, software assurance techniques used and reliability achieved.

  2. BYU Food Quality Assurance Laboratory

    Data.gov (United States)

    Federal Laboratory Consortium — The Quality Assurance Lab is located in the Eyring Science Center in the department of Nutrition, Dietetics, and Food Science. The Quality Assurance Lab has about 10...

  3. Safety and feasibility of countering neurological impairment by intravenous administration of autologous cord blood in cerebral palsy

    Directory of Open Access Journals (Sweden)

    Lee Young-Ho

    2012-03-01

    Full Text Available Abstract Backgrounds We conducted a pilot study of the infusion of intravenous autologous cord blood (CB in children with cerebral palsy (CP to assess the safety and feasibility of the procedure as well as its potential efficacy in countering neurological impairment. Methods Patients diagnosed with CP were enrolled in this study if their parents had elected to bank their CB at birth. Cryopreserved CB units were thawed and infused intravenously over 10~20 minutes. We assessed potential efficacy over 6 months by brain magnetic resonance imaging (MRI-diffusion tensor imaging (DTI, brain perfusion single-photon emission computed tomography (SPECT, and various evaluation tools for motor and cognitive functions. Results Twenty patients received autologous CB infusion and were evaluated. The types of CP were as follows: 11 quadriplegics, 6 hemiplegics, and 3 diplegics. Infusion was generally well-tolerated, although 5 patients experienced temporary nausea, hemoglobinuria, or urticaria during intravenous infusion. Diverse neurological domains improved in 5 patients (25% as assessed with developmental evaluation tools as well as by fractional anisotropy values in brain MRI-DTI. The neurologic improvement occurred significantly in patients with diplegia or hemiplegia rather than quadriplegia. Conclusions Autologous CB infusion is safe and feasible, and has yielded potential benefits in children with CP.

  4. Power transformers quality assurance

    CERN Document Server

    Dasgupta, Indrajit

    2009-01-01

    About the Book: With the view to attain higher reliability in power system operation, the quality assurance in the field of distribution and power transformers has claimed growing attention. Besides new developments in the material technology and manufacturing processes of transformers, regular diagnostic testing and maintenance of any engineering product may be ascertained by ensuring: right selection of materials and components and their quality checks. application of correct manufacturing processes any systems engineering. the user`s awareness towards preventive maintenance. The

  5. Software Quality Assurance Metrics

    Science.gov (United States)

    McRae, Kalindra A.

    2004-01-01

    Software Quality Assurance (SQA) is a planned and systematic set of activities that ensures conformance of software life cycle processes and products conform to requirements, standards and procedures. In software development, software quality means meeting requirements and a degree of excellence and refinement of a project or product. Software Quality is a set of attributes of a software product by which its quality is described and evaluated. The set of attributes includes functionality, reliability, usability, efficiency, maintainability, and portability. Software Metrics help us understand the technical process that is used to develop a product. The process is measured to improve it and the product is measured to increase quality throughout the life cycle of software. Software Metrics are measurements of the quality of software. Software is measured to indicate the quality of the product, to assess the productivity of the people who produce the product, to assess the benefits derived from new software engineering methods and tools, to form a baseline for estimation, and to help justify requests for new tools or additional training. Any part of the software development can be measured. If Software Metrics are implemented in software development, it can save time, money, and allow the organization to identify the caused of defects which have the greatest effect on software development. The summer of 2004, I worked with Cynthia Calhoun and Frank Robinson in the Software Assurance/Risk Management department. My task was to research and collect, compile, and analyze SQA Metrics that have been used in other projects that are not currently being used by the SA team and report them to the Software Assurance team to see if any metrics can be implemented in their software assurance life cycle process.

  6. Microbiological Test Data - Assuring Data Integrity.

    Science.gov (United States)

    Tidswell, Edward Charles; Sandle, Tim

    2017-10-12

    Marketed drugs and devices possess specifications including critical microbiological quality attributes purposed to assure efficacy and patient safety. These attributes are legislated requirements intended to protect the recipient patient. Sampling, microbiological testing, interpretation of data for final products, raw materials and intermediates all contribute to a cohesive assessment in the assurance of finished product quality. Traditional culture-based microbiological methods possess inherent and unavoidable variability, recognized by the compendia and which might lead to erroneous conclusion pertaining to product quality. Such variability has been associated and intrinsically linked with data integrity issues; manufacturers have subsequently been encouraged by regulatory authorities to introduce multiple microbiologists or checks to prevent such issues. Understanding microbiological variability is essential such that genuine data integrity issues are identified. Furthermore, a range of meaningful preventative strategies are feasible beyond increasing the capacity of the quality control microbiological laboratory. This short review describes the legislative requirements, inherent microbiological variability and realistic actions and activities that genuinely assure patient safety. Copyright © 2017, Parenteral Drug Association.

  7. ApproAches to AdvAncing Blood sAfety through hAemovigilAnce: A ...

    African Journals Online (AJOL)

    2009-12-01

    Dec 1, 2009 ... and anaphylaxis. the term “safe blood transfusion” implies an outcome that is totally beneficent and nonmaleficent to the patient. Safe blood practice is dependent on several factors including selection of volunteer blood donors with low risk for transfusion transmissible infections (tti), aseptic collection of.

  8. Efficacy and safety of Chinese herbal medicine for chronic prostatitis associated with damp-heat and blood-stasis syndromes: a meta-analysis and literature review.

    Science.gov (United States)

    Wang, Zhiqiang; Yuan, Lei; Wang, Yongchuan; Yang, Baizhi; Dong, Xiaohong; Gao, Zhaowang

    2016-01-01

    The aim of this meta-analysis and systematic review is to evaluate the safety and efficacy of Chinese herbal medicine (CHM) for chronic prostatitis (CP) associated with damp-heat and blood-stasis syndromes. An electronic search of 13 databases up to May 2016 was screened to identify randomized controlled trials comparing the safety and efficacy of CHM for the treatment of CP associated with damp-heat and blood-stasis syndromes. Studies reporting on effective rates, adverse events, National Institutes of Health chronic prostatitis symptom index (NIH-CPSI) scores, and symptom index of Chinese medicine for chronic prostatitis (SI-CM) scores as outcomes were included in the analysis. Data were analyzed by fixed- or random-effect models using the Review Manager software. Thirteen articles with the modified Jadad score ≥4 were identified. It was found that CHM was superior to placebo in increasing the efficacy (odds ratio: 6.72, 95% confidence interval [CI]: 2.78-9.48, P damp-heat and blood-stasis syndromes. While Prostant showed some efficacy in this disorder, it was associated with a smaller reduction in NIH-CPSI scores. In conclusion, CHM monotherapy is safe and effective for the treatment of CP associated with damp-heat and blood-stasis syndromes.

  9. Transplantation of autologous peripheral blood mononuclear cells in the subarachnoid space for amyotrophic lateral sclerosis: a safety analysis of 14 patients.

    Science.gov (United States)

    Li, Xiao-Yan; Liang, Zhan-Hua; Han, Chao; Wei, Wen-Juan; Song, Chun-Li; Zhou, Li-Na; Liu, Yang; Li, Ying; Ji, Xiao-Fei; Liu, Jing

    2017-03-01

    There is a small amount of clinical data regarding the safety and feasibility of autologous peripheral blood mononuclear cell transplantation into the subarachnoid space for the treatment of amyotrophic lateral sclerosis. The objectives of this retrospective study were to assess the safety and efficacy of peripheral blood mononuclear cell transplantation in 14 amyotrophic lateral sclerosis patients to provide more objective data for future clinical trials. After stem cell mobilization and collection, autologous peripheral blood mononuclear cells (1 × 109) were isolated and directly transplanted into the subarachnoid space of amyotrophic lateral sclerosis patients. The primary outcome measure was incidence of adverse events. Secondary outcome measures were electromyography 1 week before operation and 4 weeks after operation, Functional Independence Measurement, Berg Balance Scale, and Dysarthria Assessment Scale 1 week preoperatively and 1, 2, 4 and 12 weeks postoperatively. There was no immediate or delayed transplant-related cytotoxicity. The number of leukocytes, serum alanine aminotransferase and creatinine levels, and body temperature were within the normal ranges. Radiographic evaluation showed no serious transplant-related adverse events. Muscle strength grade, results of Functional Independence Measurement, Berg Balance Scale, and Dysarthria Assessment Scale were not significantly different before and after treatment. These findings suggest that peripheral blood mononuclear cell transplantation into the subarachnoid space for the treatment of amyotrophic lateral sclerosis is safe, but its therapeutic effect is not remarkable. Thus, a large-sample investigation is needed to assess its efficacy further.

  10. Transfusion safety in francophone African countries: an analysis of strategies for the medical selection of blood donors.

    Science.gov (United States)

    Tagny, Claude Tayou; Kouao, Maxime Diané; Touré, Hamane; Gargouri, Jalel; Fazul, Ahamada Said; Ouattara, Siaka; Anani, Ludovic; Othmani, Habiba; Feteke, Lochina; Dahourou, Honorine; Mbensa, Guy Olivier; Molé, Simplice; Nébié, Yacouba; Mbangue, Madeleine; Toukam, Michel; Boulahi, Mahommed Ould; Andriambelo, Lalatiana Valisoa; Rakoto, Olivat; Baby, Mounirou; Yahaya, Rakia; Bokilo, Amelia; Senyana, Florent; Mbanya, Dora; Shiboski, Caroline; Murphy, Edward L; Lefrère, Jean Jacques

    2012-01-01

    The goal of selecting a healthy blood donor is to safeguard donors and reduce the risks of infections and immunologic complications for recipients. To evaluate the blood donor selection process, a survey was conducted in 28 blood transfusion centers located in 15 francophone African countries. Data collected included availability of blood products, risk factors for infection identified among blood donor candidates, the processing of the information collected before blood collection, the review process for the medical history of blood donor candidates, and deferral criteria for donor candidates. During the year 2009, participating transfusion centers identified 366,924 blood donor candidates. A mean of 13% (range, 0%-36%) of the donor candidates were excluded based solely on their medical status. The main risk factors for blood-borne infections were having multiple sex partners, sexual intercourse with occasional partners, and religious scarification. Most transfusion centers collected this information verbally instead of having a written questionnaire. The topics least addressed were the possible complications relating to the donation, religious scarifications, and history of sickle cell anemia and hemorrhage. Only three centers recorded the temperature of the blood donors. The deferral criteria least reported were sickle cell anemia, piercing, scarification, and tattoo. The medical selection process was not performed systemically and thoroughly enough, given the regional epidemiologic risks. It is essential to identify the risk factors specific to francophone African countries and modify the current medical history questionnaires to develop a more effective and relevant selection process. © 2011 American Association of Blood Banks.

  11. Development of quality assurance procedures for production of sealed radiation source

    CERN Document Server

    Nam, J H; Cho, W K; Han, H S; Hong, S B; Kim, K H; Kim, S D; Lee, Y G; Lim, N J

    2001-01-01

    The quality assurance procedures for sealed radiation sources production using HANARO and RIPF have been developed. The detailed quality assurance procedures are essential to manage the whole work process effectively and ensure the quality of the produced sealed sources. Through applying this quality assurance procedures to the entire production works of the sealed radiation sources, it is expected that the quality of the products, the safety of the works and the satisfaction of the customers will be increased.

  12. The PARTI Architecture Assurance

    Science.gov (United States)

    2008-10-01

    reasoning tools. In this paper, we demonstrate the feasibility of such formal argument through the presentation of a formal verification argument for a simplified case study in Defence safety engineering.

  13. The case of sustainability assurance: constructing a new assurance service

    NARCIS (Netherlands)

    O'Dwyer, B.

    2011-01-01

    This paper presents an in-depth longitudinal case study examining the processes through which practitioners in two Big 4 professional services firms have attempted to construct sustainability assurance (independent assurance on sustainability reports). Power’s (1996, 1997, 1999, 2003) theorization

  14. Construction quality assurance report

    Energy Technology Data Exchange (ETDEWEB)

    Roscha, V.

    1994-09-08

    This report provides a summary of the construction quality assurance (CQA) observation and test results, including: The results of the geosynthetic and soil materials conformance testing. The observation and testing results associates with the installation of the soil liners. The observation and testing results associated with the installation of the HDPE geomembrane liner systems. The observation and testing results associated with the installation of the leachate collection and removal systems. The observation and testing results associated with the installation of the working surfaces. The observation and testing results associated with in-plant manufacturing process. Summary of submittal reviews by Golder Construction Services, Inc. The submittal and certification of the piping material specifications. The observation and verification associated of the Acceptance Test Procedure results of the operational equipment functions. Summary of the ECNs which are incorporated into the project.

  15. FESA Quality Assurance

    CERN Multimedia

    CERN. Geneva

    2015-01-01

    FESA is a framework used by 100+ developers at CERN to design and implement the real-time software used to control the accelerators. Each new version must be tested and qualified to ensure that no backward compatibility issues have been introduced and that there is no major bug which might prevent accelerator operations. Our quality assurance approach is based on code review and a two-level testing process. The first level is made of unit-test (Python unittest & Google tests for C++). The second level consists of integration tests running on an isolated test environment. We also use a continuous integration service (Bamboo) to ensure the tests are executed periodically and the bugs caught early. In the presentation, we will explain the reasons why we took this approach, the results and some thoughts on the pros and cons.

  16. Concrete quality assurance

    Energy Technology Data Exchange (ETDEWEB)

    Holz, N. [Harza Engineering Company, Chicago, IL (United States)

    2000-08-01

    This short article reports on progress at the world's largest civil construction project, namely China's Three Gorges hydro project. Work goes on around the clock to put in place nearly 28 M m{sup 3} of concrete. At every stage of the work there is strong emphasis on quality assurance (QA) and concrete is no exception. The US company Harza Engineering has been providing QA since the mid-1980s and concrete QA has been based on international standards. Harza personnel work in the field with supervisors developing educational tools for supervising concrete construction and quality, as well as providing training courses in concrete technology. Some details on flood control, capacity, water quality and environmental aspects are given..

  17. [Effects of xenon anesthesia on cerebral blood flow in neurosurgical patients without intracranial hypertension].

    Science.gov (United States)

    Rylova, A V; Beliaev, A Iu; Lubnin, A Iu

    2013-01-01

    Among anesthetic agents used in neurosurgery xenon appears to be the most advantageous. It preserves arterial blood pressure, assures rapid recovery and neuroprotection. But the data is lacking on xenon effect upon cerebral blood flow under anesthetic conditions. We measured flow velocity in middle cerebral artery in neurosurgical patients without intracranial hypertension during closed circuit xenon anesthesia comparing propofol and xenon effect in the same patients. In our study xenon didn't seem to induce clinically relevant changes in cerebral blood flow and preserved cerebral vascular reactivity thus proving its safety in patients without intracranial hypertension.

  18. Recent Trends in Quality Assurance

    Science.gov (United States)

    Amaral, Alberto; Rosa, Maria Joao

    2010-01-01

    In this paper we present a brief description of the evolution of quality assurance in Europe, paying particular attention to its relationship to the rising loss of trust in higher education institutions. We finalise by analysing the role of the European Commission in the setting up of new quality assurance mechanisms that tend to promote…

  19. QANU - Quality Assurance Netherlands Universities

    DEFF Research Database (Denmark)

    Jensen, Henrik Toft; Maria E., Weber; Vyt, André

    The Quality Assurance Netherlands Universities (QANU) underwent an ENQA-coordinated external review in 2016. The review was chaired by Henrik Toft Jensen, Research fellow at Roskilde University (RUC), Denmark.......The Quality Assurance Netherlands Universities (QANU) underwent an ENQA-coordinated external review in 2016. The review was chaired by Henrik Toft Jensen, Research fellow at Roskilde University (RUC), Denmark....

  20. The Safety and Therapeutic Effectiveness of Nonwashed Mediastinal Shed Blood Reinfused Into Patients Following Open Heart Surgery

    Science.gov (United States)

    1992-05-06

    Brea, CA). Total protein and albumin levels were measured by the Biuret reactions method of Kingsley [11]. Factor V (% normal), Factor VIII...mediastinal blood which could be transfused without producing hemorrhagic complications. PATIENTS AND METHODS Patients. The experimental protocol for this...related hematologic functions following cardiopulmonary bypass for open heart surgery. Methods to minimize the use of homologous blood replacement

  1. Tainted blood

    DEFF Research Database (Denmark)

    Deleuran, Ida; Sheikh, Zainab Afshan; Hoeyer, Klaus

    2015-01-01

    study of the historical rise and current workings of safety practices in the Danish blood system. Here, we identify a strong focus on contamination in order to avoid 'tainted blood', at the expense of working with risks that could be avoided through enhanced blood monitoring practices. Of further...... significance to this focus are the social dynamics found at the heart of safety practices aimed at avoiding contamination. We argue that such dynamics need more attention, in order to achieve good health outcomes in transfusion medicine. Thus, we conclude that, to ensure continuously safe blood systems, we...... need to move beyond the bifurcation of the social and medical aspects of blood supply as two separate issues and approach social dynamics as key medical safety questions....

  2. Patient safety: Safety culture and patient safety ethics

    OpenAIRE

    Madsen, Marlene Dyrløv

    2006-01-01

    Patient safety - the prevention of medical error and adverse events - and the initiative of developing safety cultures to assure patients from harm have become one of the central concerns in quality improvement in healthcare both nationally andinternationally. This subject raises numerous challenging issues of systemic, organisational, cultural and ethical relevance, which this dissertation seeks to address through the application of different disciplinary approaches. The main focus of resear...

  3. The efficacy and safety of autologous blood transfusion drainage in patients undergoing total knee arthroplasty: a meta-analysis of 16 randomized controlled trials.

    Science.gov (United States)

    Pan, Jian-Ke; Hong, Kun-Hao; Xie, Hui; Luo, Ming-Hui; Guo, Da; Liu, Jun

    2016-11-02

    Autologous blood transfusion drainage (ABTD) has been used for many years to reduce blood loss in total knee arthroplasty (TKA). We evaluate the current evidence concerning the efficiency and safety of ABTD used in TKA compared with conventional suction drainage (CSD). We performed a systematic literature search of the PubMed, Embase, Cochrane Library and four Chinese databases. All randomized controlled trials (RCTs) that compared the effects of ABTD versus CSD in TKA were included in the meta-analysis. Sixteen RCTs involving 1534 patients who compared the effects of ABTD versus CSD were included. Five of the RCTs were performed in Asia, ten in Europe, and one in North America. Patients in the ABTD group had a lower blood transfusion rate (OR: 0.25 [0.13, 0.47]; Z = 4.27, P analysis suggests that ABTD is a safe and effective method that yields a lower blood transfusion rate and fewer units transfused per patient in TKA compared with CSD.

  4. Hepatitis E virus in the countries of the Middle East and North Africa region: an awareness of an infectious threat to blood safety.

    Science.gov (United States)

    Yazbek, Soha; Kreidieh, Khalil; Ramia, Sami

    2016-02-01

    Hepatitis E virus (HEV) is mainly transmitted through contaminated water supplies which make the virus endemic in developing countries including countries of the Middle East and North Africa (MENA) region. Recent reports suggest potential risk of HEV transmission via blood transfusion. Related articles on HEV were collected by searching through the 25 countries of the MENA region using Pubmed and Medline within the past 14 years: January 2000-August 2014. One hundred articles were extracted, of which 25 were not eligible. The articles discussed the seroprevalence of HEV and HEV markers in 12 countries. Eight articles provided data on HEV in blood donors. The seroprevalence of HEV in the general MENA population ranged from 2.0 to 37.5% and was higher in males than in females. Prevalence increased with age, but exposure seems to be in early life. In the MENA region, the role of HEV as an infectious threat to blood safety is under-investigated. More data are needed to quantify the risk of transmission and to assess clinical outcomes. This requires, at least, surveillance screening of donors and recipients for HEV markers using sensitive and specific serological tests. At the present time, serious consideration should be given to selective screening for certain groups of patients (e.g., immunocompromised, pregnant women and others) who commonly require blood transfusion and are at high risk of hepatic failure or chronicity from HEV infection.

  5. Assuring Software Reliability

    Science.gov (United States)

    2014-08-01

    which include infusion pumps, undergo a scien - tific and regulatory review to evaluate their safety and effectiveness. But infusion pumps that...resources.sei.cmu.edu/ library /asset-view.cfm?AssetID=9323 [FDA 2010] U.S. Food and Drug Administration. Guidance for Industry and FDA Staff Total Product...resources.sei.cmu.edu/ library /asset-view.cfm?AssetID=9145 CMU/SEI-2014-SR-008 | 32 [Feiler 2012] Feiler, Peter; Goodenough, John; Gurfinkel, Arie; Weinstock

  6. Cord blood banking and quality issues.

    Science.gov (United States)

    Murphy, Amanda; McKenna, David; McCullough, Jeffrey

    2016-03-01

    Food and Drug Administration guidelines are designed to assure the quality and safety of the cord blood product used for transplantation. It is valuable to determine whether the actions called for in these guidelines are effective. We applied our cell therapy quality system to all cord blood units shipped into our cellular therapy laboratory for transplant at the University of Minnesota between 2011 and 2013. The quality issues were categorized as likely, potentially, or unlikely to have a clinical impact. A total of 249 units of umbilical cord blood (UCB) were received from 16 cord blood banks. A total of 159 units (64%) had a total of 245 issues. Of these, 117 (48%) pertained to medical history, 120 (49%) to quality control, and eight (3%) to labeling and documentation. Units with quality issues were no more likely to fail to engraft, and no specific kind of quality issue was associated with failure to engraft. Compared to a similar study 10 years ago, there was a decrease in the number of issues per unit. The cost of collecting, testing, processing, and storing UCB is very high. However, there may be activities that do not contribute to the quality or safety of the cord blood. The guidelines could be reviewed to determine their value based on years of experience. © 2015 AABB.

  7. Material quality assurance risk assessment.

    Science.gov (United States)

    2013-01-01

    Over the past two decades the role of SHA has shifted from quality control (QC) of materials and : placement techniques to quality assurance (QA) and acceptance. The role of the Office of Materials : Technology (OMT) has been shifting towards assuran...

  8. Quality Assurance Training Tracking (QATTS)

    Data.gov (United States)

    U.S. Environmental Protection Agency — This is metadata documentation for the Quality Assurance Training Tracking System (QATTS) which tracks Quality Assurace training given by R7 QA staff to in-house...

  9. Information Assurance Technical Framework (IATF)

    National Research Council Canada - National Science Library

    2000-01-01

    The Information Assurance Technical Framework (IATF) document was developed to help a broad audience of users both define and understand their technical needs as well as select approaches to meet those needs...

  10. Analytical strategies for the early quality and safety assurance in the global feed chain. Approaches for nitrogen adulterants in soybean meal and mineral and transformer oils in vegetable oils

    NARCIS (Netherlands)

    Jong, de Jacob; Lopez Sanchez, Patricia; Mol, Hans

    2016-01-01

    In the past decade, several major food safety crises originated from problems with feed. Consequently, there is an urgent need for early detection of fraudulent adulteration and contamination in the feed chain. Strategies are presented for two specific cases, viz. adulterations of (i) soybean

  11. Physical aspects of quality assurance in nuclear medicine and radiotherapy, regulatory approach of the National Nuclear Safety Center; Aspectos fisicos de garantia de calidad en medicina nuclear y radioterapia. Enfoque regulatorio del centro Nacional de Seguridad Nuclear

    Energy Technology Data Exchange (ETDEWEB)

    Gonzalez C, D.; Fuente P, A. de la; Quevedo G, J.R.; Lopez F, Y. [CNSN, Calle 28 No. 504 e/5 y 7, Ave. Miramar, La Habana (Cuba); Varela C, C. [CCEEM, Calle 4 No. 455 e/19 y 21, Ave. Vedado, La Habana (Cuba)]. e-mail: cruz@orasen.co.cu

    2006-07-01

    The physical aspects of the quality guarantee in Nuclear Medicine and Radiotherapy its are of cardinal importance to guarantee the quality of the diagnoses and treatments that are carried out to the patients in this type of services. The OIEA, the OMS and other scientific and professional organizations have contributed significantly to the elaboration of recommendations, Protocols, etc. applicable in the quality control programs and safety of the Nuclear Medicine and Radiotherapy departments. In spite of the great effort developed in this sense the Installation of the programs of quality control and safety of the Nuclear Medicine and Radiotherapy departments can fail if the same ones are not based in three decisive elements that are: the existence of national regulations, the existence of the infrastructure required for it and the existence of enough qualified personnel to develop this programs. The present work shows the regulatory focus that on this topic, it has followed the National Center of Nuclear Safety of Cuba (CNSN). The same left of strengthen all the existent Synergies in the different organizations of the country and it went in two fundamental directions: installation of the regulatory requirements that govern this activity and the Authorization of a Cuban Entity, specialized in carrying out audits to the quality control and safety programs of the Nuclear Medicine and Radiotherapy departments. After 4 work years in this direction, the results confirm the validity of the experience developed by the CNSN, at the moment all the services of Nuclear Medicine and Radiotherapy of Cuba possess quality control and safety programs, these programs are annually Auditing by an Authorized entity by the CNSN and the Inspectors of the Regulatory Authority, control, during the inspections, the one execution of the established requirements in the national regulations. The work developed so far can serve, modestly, of reference to others countries of Latin America that

  12. The granulocytes in neutropenia 1 (GIN 1) study: a safety study of granulocytes collected from whole blood and stored in additive solution and plasma.

    Science.gov (United States)

    Massey, Edwin; Harding, Kay; Kahan, Brennan C; Llewelyn, Charlotte; Wynn, Robert; Moppett, John; Robinson, Stephen P; Green, Ann; Lucas, Geoff; Sadani, Deepak; Liakopoulou, Effie; Bolton-Maggs, Paula; Marks, David I; Stanworth, Simon

    2012-08-01

    To evaluate the safety of transfusing pooled, whole blood-derived granulocytes in additive solution and plasma (GASP) in 30 recipients. Demand for granulocytes in England has increased five-fold. With the advantages of reduced red cell, plasma and overall volume, GASP maintains function in vitro. Observations were recorded prior to and post transfusion. Increments were recorded at 1 h and the following morning. Leucocyte antibody screening was undertaken prior to and at 1-6 months following transfusion. Thirty patients aged between 8 months and 68 years received 221 GASP in 148 transfusion episodes. GASP contained an average of 1.0 × 10(10) granulocytes in 207 mL. Adults usually received two packs and children 10-20 mL kg(-1). Children and adults received a median [interquartile range (IQR)] dose of 12.5 (9.1-25.3) and 19.7 (12.0-25.8) × 10(9) granulocytes per transfusion, respectively. There was one episode of transfusion-associated circulatory overload (TACO) in a patient with chronic cardiac failure following 600 mL of unpooled granulocytes, other fluids and one GASP. New leucocyte alloimmunisation occurred in 3/30 recipients 10%. No other significant reactions were reported. Median peripheral blood neutrophil increments at 1 h post transfusion were 0.06 (IQR, 0.01-0.17) in children and (0.03) (IQR, 0-0.16) in adults. GASP has a similar safety profile to other sources of granulocytes for patients with refractory infection or in need of secondary prophylactic transfusion. Further studies are required to clarify the role of GASP in the treatment of neutropenic patients. © 2012 The Authors. Transfusion Medicine © 2012 British Blood Transfusion Society.

  13. Preliminary safety information document for the standard MHTGR. Volume 4

    Energy Technology Data Exchange (ETDEWEB)

    None

    1986-01-01

    This report contains information concerning: operational radionuclide control; occupational radiation protection, conduct of operations; initial test program; safety analysis; technical specifications; and quality assurance. (JDB)

  14. Determinants for conducting food safety culture research

    NARCIS (Netherlands)

    Nyarugwe, Shingai P.; Linnemann, Anita; Hofstede, Gert Jan; Fogliano, Vincenzo; Luning, Pieternel A.

    2016-01-01

    Background Foodborne outbreaks continue to occur regardless of existing food safety measures indicating the shortcomings of these measures to assure food safety. This has led to the recognition of food safety culture as a key contributory factor to the food safety performance of food

  15. Diagnosis of High Blood Pressure

    Medline Plus

    Full Text Available ... Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep Science and Sleep Disorders Lung Diseases Heart and Vascular Diseases Precision Medicine ...

  16. Patient safety: Safety culture and patient safety ethics

    DEFF Research Database (Denmark)

    Madsen, Marlene Dyrløv

    2006-01-01

    Patient safety - the prevention of medical error and adverse events - and the initiative of developing safety cultures to assure patients from harm have become one of the central concerns in quality improvement in healthcare both nationally andinternationally. This subject raises numerous...... the problems, and suggest possible solutions for improving patient safety through the promotion of safety culture and ethics. I seek to illuminate theissues of patient safety from several perspectives; the organizational healthcare system, in particular the healthcare workers perspectives and experiences......, and those of patients who experience the physical effect of poor patient safety. The dissertationconsists of nine papers and an appendix. Paper 1 describes the results of doctors and nurses attitudes towards reporting and the handling of adverse events. Paper 2 is a study and “review” of the international...

  17. Quality assurance in digital dental imaging: a systematic review.

    Science.gov (United States)

    Metsälä, Eija; Henner, Anja; Ekholm, Marja

    2014-07-01

    Doses induced by individual dental examinations are low. However, dental radiography accounts for nearly one third of the total number of radiological examinations in the European Union. Therefore, special attention is needed with regard to radiation protection. In order to lower patient doses, the staff performing dental examinations must have competence in imaging as well as in radiation protection issues. This paper presents a systematic review about the core competencies needed by the healthcare staff in performing digital dental radiological imaging quality assurance. The following databases were searched: Pubmed, Cinahl, Pro Quest and IEEXplore digital library. Also volumes of some dental imaging journals and doctoral theses of the Finnish universities educating dentists were searched. The search was performed using both MeSH terms and keywords using the option 'search all text'. The original keywords were: dental imaging, digital, x-ray, panoramic, quality, assurance, competence, competency, skills, knowledge, radiographer, radiologist technician, dentist, oral hygienist, radiation protection and their Finnish synonyms. Core competencies needed by the healthcare staff performing digital dental radiological imaging quality assurance described in the selected studies were: management of dental imaging equipment, competence in image quality and factors associated with it, dose optimization and quality assurance. In the future there will be higher doses in dental imaging due to increasing use of CBCT and digital imaging. The staff performing dental imaging must have competence in dental imaging quality assurance issues found in this review. They also have to practice ethical radiation safety culture in clinical practice.

  18. Review of SKB's Quality Assurance Programme

    Energy Technology Data Exchange (ETDEWEB)

    Baldwin, Tamara D.; Hicks, Timothy W. (Galson Sciences LTD, Oakham, Rutland (United Kingdom))

    2009-06-15

    SKB is preparing a license application for the construction of a final repository for spent nuclear fuel in Sweden. This application will be supported by the safety assessment SR-Site for the post-closure phase. The assessment of long-term safety is based on a broad range of experimental results from laboratory scale, intermediate scale and up to full scale experiments. It is essential that there is a satisfactory level of assurance that experiments have been carried of with sufficient quality, so that results can be considered to be reliable within the context of their use in safety assessment. SSM has initiated a series of reviews of SKB's methods of quality assurance and their implementation. This project includes reviews of the quality assurance (QA) procedures and instructions that have been prepared for the SR-Site assessment as well as reviews of QA implementation at the canister and buffer/backfill laboratories in Oskarshamn, Sweden. The purpose of this project is to assess SKB's quality assurance with the view of providing a good basis for subsequent quality reviews in the context of future licensing. This has been achieved by examination of a number of SKB experiments using a check list, visits to the relevant facilities, and meetings with contractors and a few members of the SKB staff. Overall, the reviewed set of QA documents and instructions do provide reasonably comprehensive coverage of quality-affecting issues relating to the SR-Site safety assessment and, if implemented correctly, will generate confidence in the reliability of the safety assessment results. The results show that the efforts involving quality assurance are increasing within the SKB programme and in general appear to be satisfactory for ongoing experiments and measurements. However, progress in development of the QA documents and instructions has been relatively recent and it may be difficult for these to be fully implemented in the short period remaining before the planned

  19. A Phase II pilot trial to evaluate safety and efficacy of ferroquine against early Plasmodium falciparum in an induced blood-stage malaria infection study.

    Science.gov (United States)

    McCarthy, James S; Rückle, Thomas; Djeriou, Elhadj; Cantalloube, Cathy; Ter-Minassian, Daniel; Baker, Mark; O'Rourke, Peter; Griffin, Paul; Marquart, Louise; Hooft van Huijsduijnen, Rob; Möhrle, Jörg J

    2016-09-13

    Ferroquine (SSR97193) is a candidate anti-malarial currently undergoing clinical trials for malaria. To better understand its pharmacokinetic (PK) and pharmacodynamic (PD) parameters the compound was tested in the experimentally induced blood stage malaria infection model in volunteers. Male and non-pregnant female aged 18-50 years were screened for this phase II, controlled, single-centre clinical trial. Subjects were inoculated with ~1800 viable Plasmodium falciparum 3D7A-infected human erythrocytes, and treated with a single-dose of 800 mg ferroquine. Blood samples were taken at defined time-points to measure PK and PD parameters. The blood concentration of ferroquine and its active metabolite, SSR97213, were measured on dry blood spot samples by ultra-performance liquid chromatography with tandem mass spectrometry (LC-MS/MS). Parasitaemia and emergence of gametocytes were monitored by quantitative PCR. Safety was determined by recording adverse events and monitoring clinical laboratory assessments during the course of the study. Eight subjects were enrolled into the study, inoculated with infected erythrocytes and treated with 800 mg ferroquine. Ferroquine was rapidly absorbed with maximal exposure after 4-8 and 4-12 h exposure for SSR97213. Non-compartmental PK analysis resulted in estimates for half-lives of 10.9 and 23.8 days for ferroquine and SSR97213, respectively. Parasite clearance as reported by parasite reduction ratio was 162.9 (95 % CI 141-188) corresponding to a parasite clearance half-life of 6.5 h (95 % CI: 6.4-6.7 h). PK/PD modelling resulted in a predicted minimal parasiticidal concentration of 20 ng/mL, and the single dosing tested in this study was predicted to maintain an exposure above this threshold for 454 h (37.8 days). Although ferroquine was overall well tolerated, transient elevated transaminase levels were observed in three subjects. Paracetamol was the only concomitant treatment among the two out of these three subjects

  20. Measures taken by the French Health Minister to ensure safety in radiotherapy treatments;Les mesures prises par la Ministre de la Sante pour assurer la securite des traitements en radiotherapie

    Energy Technology Data Exchange (ETDEWEB)

    Bachelot-Narquin, R. [Ministre de la Sante et des Sports, 75 - Paris (France)

    2009-12-15

    The objective of these measures is to restore the confidence of patients and professionals in an essential practice for the treatment of cancers and that is in constant progression. 70% of patients suffering of a cancer receive every year a radiotherapy. The national measures aim to strengthen the safety of practice, the quality of cares, the vigilance on the unwanted effects. among the measures we find in vivo dosimetry, doubling of radio physicists and then pass from 300 radio physicists in 2007 to 600 in 2012. (N.C.)

  1. Quality assurance of qualitative analysis

    DEFF Research Database (Denmark)

    Ríos, Ángel; Barceló, Damiá; Buydens, Lutgarde

    2003-01-01

    The European Commission has supported the G6MA-CT-2000-01012 project on "Metrology of Qualitative Chemical Analysis" (MEQUALAN), which was developed during 2000-2002. The final result is a document produced by a group of scientists with expertise in different areas of chemical analysis, metrology...... and quality assurance. One important part of this document deals, therefore, with aspects involved in analytical quality assurance of qualitative analysis. This article shows the main conclusions reported in the document referring to the implementation of quality principles in qualitative analysis...

  2. Quality assurance of endoscopy units.

    Science.gov (United States)

    Stebbing, John F

    2011-06-01

    This chapter reflects on how England has led the world in service development and quality assurance of endoscopy. It draws out themes of leadership, strategic vision and organisational culture. It emphasises the pivotal importance of focussing service improvement on enhancing the quality of a patient's experience of endoscopy. It describes the processes used here for quality assurance of endoscopy units and how these have dovetailed with other strands of work in transforming the English endoscopy service. The chapter presents discussion of the responses to accreditation processes and how the design of the JAG Accreditation process maximises its effectiveness. Copyright © 2011 Elsevier Ltd. All rights reserved.

  3. The Science of Mission Assurance

    Directory of Open Access Journals (Sweden)

    Kamal Jabbour

    2011-01-01

    Full Text Available The intent of this article is to describe—and prescribe—a scientific framework for assuring mission essential functions in a contested cyber environment. Such a framework has profound national security implications as the American military increasingly depends on cyberspace to execute critical mission sets. In setting forth this prescribed course of action, the article will first decompose information systems into atomic processes that manipulate information at all six phases of the information lifecycle, then systematically define the mathematical rules that govern mission assurance.

  4. Animal Product Safety Information

    Science.gov (United States)

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Animal & Veterinary Home Animal & Veterinary Safety & Health Product Safety ... for more information. How to report when your animal has a bad reaction to a drug the ...

  5. Safety evaluation of daidzein in laying hens: Effects on laying performance, hatchability, egg quality, clinical blood parameters, and organ development.

    Science.gov (United States)

    Lu, J; Qu, L; Shen, M M; Li, S M; Dou, T C; Hu, Y P; Wang, K H

    2017-07-01

    Daidzein has become increasingly popular as a dietary supplement, particularly for postpeak-estrus animals, as a safe and natural alternative estrogen-like compound. However, there is little available safety data of daidzein in laying hens. A study was conducted to examine if high-dose daidzein affected the safety of hens, including mortality, laying performance, egg quality, hematological parameters, clinical chemical parameters, organ development parameters, and hatchability. A total of 2,448 42-wk-old Rugao laying hens were randomly assigned to 4 groups with 6 replicates of 102 birds each (612 laying hens per group). After a 2-wk acclimation period, the birds were fed diets supplemented with 0, 10, 100, or 200 mg/kg of daidzein for 12 wk. The hatchability of setting eggs increased linearly with increasing dietary daidzein supplementation (P = 0.034), while the hatchability of fertile eggs also tended to increase linearly (P = 0.069). The red cell distribution width (RCDW) and coefficient variation of RCDW showed an increasing and then decreasing quadratic response to increasing dietary daidzein supplementation (P = 0.001 and 0.002, respectively). No statistically significant changes were observed in mortality, laying performance, egg quality, clinical chemistry parameters, or organ development parameters (P > 0.05). The magnitude of these hematological changes was such that they were considered to be of no toxicological significance. Therefore, a nominal daidzein concentration of 200 mg/kg is not expected to cause adverse effects following daily administration to laying hens for 84 d. © 2017 Poultry Science Association Inc.

  6. Safety and feasibility for pediatric cardiac regeneration using epicardial delivery of autologous umbilical cord blood-derived mononuclear cells established in a porcine model system.

    Science.gov (United States)

    Cantero Peral, Susana; Burkhart, Harold M; Oommen, Saji; Yamada, Satsuki; Nyberg, Scott L; Li, Xing; O'Leary, Patrick W; Terzic, Andre; Cannon, Bryan C; Nelson, Timothy J

    2015-02-01

    Congenital heart diseases (CHDs) requiring surgical palliation mandate new treatment strategies to optimize long-term outcomes. Despite the mounting evidence of cardiac regeneration, there are no long-term safety studies of autologous cell-based transplantation in the pediatric setting. We aimed to establish a porcine pipeline to evaluate the feasibility and long-term safety of autologous umbilical cord blood mononuclear cells (UCB-MNCs) transplanted into the right ventricle (RV) of juvenile porcine hearts. Piglets were born by caesarean section to enable UCB collection. Upon meeting release criteria, 12 animals were randomized in a double-blinded fashion prior to surgical delivery of test article (n=6) or placebo (n=6). The UCB-MNC (3×10(6) cells per kilogram) or control (dimethyl sulfoxide, 10%) products were injected intramyocardially into the RV under direct visualization. The cohorts were monitored for 3 months after product delivery with assessments of cardiac performance, rhythm, and serial cardiac biochemical markers, followed by terminal necropsy. No mortalities were associated with intramyocardial delivery of UCB-MNCs or placebo. Two animals from the placebo group developed local skin infection after surgery that responded to antibiotic treatment. Electrophysiological assessments revealed no arrhythmias in either group throughout the 3-month study. Two animals in the cell-therapy group had transient, subclinical dysrhythmia in the perioperative period, likely because of an exaggerated response to anesthesia. Overall, this study demonstrated that autologous UCB-MNCs can be safely collected and surgically delivered in a pediatric setting. The safety profile establishes the foundation for cell-based therapy directed at the RV of juvenile hearts and aims to accelerate cell-based therapies toward clinical trials for CHD. ©AlphaMed Press.

  7. Infection with human T-lymphotropic virus types-1 and -2 (HTLV-1 and -2): Implications for blood transfusion safety

    Science.gov (United States)

    Murphy, E.L.

    2016-01-01

    Many countries currently perform antibody screening for HTLV-1 infection in blood donors, and this intervention is likely cost-effective in preventing HTLV-1 related diseases in high prevalence countries. However, a number of high-income countries with low prevalence of HTLV-1 infection also perform universal HTLV-1 screening and debate has arisen regarding the cost-effectiveness of these strategies. Filter-based leukoreduction is likely to substantially reduce HTLV-1 transmission by removing infected lymphocytes, but actual laboratory data on its efficacy is currently lacking. Similarly, cost-effectiveness research on HTLV-1 prevention strategies is limited by poor data on prevalence, transmission efficacy and the cost of treating HTLV1 diseases. PMID:26778839

  8. Resistance to synthetic blood penetration of National Institute for Occupational Safety and Health-approved N95 filtering facepiece respirators and surgical N95 respirators

    Science.gov (United States)

    Rengasamy, Samy; Sbarra, Deborah; Nwoko, Julian; Shaffer, Ronald

    2015-01-01

    Background Surgical N95 filtering facepiece respirators (FFRs), certified by the National Institute for Occupational Safety and Health (NIOSH) as a respirator and cleared by the Food and Drug Administration (FDA) as a surgical mask, are often used to protect from the inhalation of infectious aerosols and from splashes/sprays of body fluids in health care facilities. A shortage of respirators can be expected during a pandemic. The availability of surgical N95 FFRs can potentially be increased by incorporating FDA clearance requirements in the NIOSH respirator approval process. Methods Fluid resistance of NIOSH-approved N95 FFRs, and FDA-cleared surgical N95 FFRs and surgical masks was tested using the ASTM F1862 method at 450 and 635 cm/sec velocities and compared with the results from a third-party independent laboratory. Blood penetration through different layers of filter media of masks were also analyzed visually. Results Four N95 FFR models showed no test failures at both velocities. The penetration results obtained in the NIOSH laboratory were comparable to those from the third-party independent laboratory. The number of respirator samples failing the test increased with increasing test velocity. Conclusions The results indicate that several NIOSH-approved N95 FFR models would likely pass FD clearance requirements for resistance to synthetic blood penetration. PMID:26231551

  9. The effectiveness and safety of aminocaproic acid for reducing blood loss in total knee and hip arthroplasty: A meta-analysis.

    Science.gov (United States)

    Dong, Qiang; Zhang, Yinguang; Sun, Xiang; Hu, Fangke

    2018-02-19

    This meta-analysis aimed to evaluate the safety and efficacy of aminocaproic acid in total knee arthroplasty (TKA) and total hip arthroplasty (THA). The electronic databases include PubMed, Medline, Embase, Web of Science and the Cochrane Library from inception to January 2018. Two reviewers abstracted total blood loss, hemoglobin drop, transfusion requirements, and postoperative complications. Data were using fixed-effects or random-effects models with weighted mean differences and risk difference for continuous and dichotomous variables, respectively. STATA 14.0 was used to perform the meta-analysis. Six studies encompassing 756 participants were retrieved for this meta-analysis. Our study indicated that intravenous aminocaproic acid was associated with a significantly reduction in total blood loss, hemoglobin drop and need for transfusion. Additionally, no increased risk of thromboembolic events were identified. Based on the present meta-analysis, intravenous aminocaproic acid is effective and safe in total knee and hip arthroplasty without increasing the incidence of thromboembolic events. Further studies should focus on the comparison of aminocaproic acid and TXA in arthroplasties. Copyright © 2018. Published by Elsevier Ltd.

  10. Safety of hydrogen pressure gauges.

    Science.gov (United States)

    Voth, R. O.

    1972-01-01

    Study of the relative safety afforded an operator by various hydrogen-pressure gauge case designs. It is shown that assurance of personnel safety, should a failure occur, requires careful selection of available gauge designs, together with proper mounting. Specific gauge case features and mounting requirements are recommended.

  11. Quality assurance in postgraduate medical education: implications for dermatology residency training programs.

    Science.gov (United States)

    Day, Isaiah; Lin, Andrew

    2012-01-01

    In the past few years, quality assurance has become an increasingly important part of medical education for both Canadian and American training programs. Since this emphasis on quality assurance in residency programs is recent, most faculty members involved in teaching residents in dermatology training programs would not themselves have had experience with quality assurance. As a result, satisfying this requirement may be a challenge. In this article, we review published reports in which various residency training programs have satisfied this requirement and propose projects in which dermatology residency training programs may satisfy quality assurance requirements. Using the key words residency, training, project, quality, assurance, improvement, medical errors, and safety, a literature search was conducted of English-language articles published after January 1990. There are many innovative and effective ways program directors in dermatology training programs should be able to develop projects that improve patient care, enhance resident education, and fulfill accreditation requirements.

  12. Employer-Led Quality Assurance

    Science.gov (United States)

    Tyszko, Jason A.

    2017-01-01

    Recent criticism of higher education accreditation has prompted calls for reform and sparked interest in piloting alternative quality assurance methods that better address student learning and employment outcomes. Although this debate has brought much needed attention to improving the outcomes of graduates and safeguarding federal investment in…

  13. Assurance Cases for Medical Devices

    Science.gov (United States)

    2011-04-28

    Mindmanager (or similar) is very good for brainstorming. 2.  GSNCaseMaker is a set of unsupported Visio macros. Tooling 38b 45 Assurance Cases for...very good for brainstorming. 2.  GSNCaseMaker is a set of unsupported Visio macros. S1 Argue over hazards C1 Pump is safe Cx1 Hazards: environmental

  14. Quality Assurance Program. QAP Workbook.

    Science.gov (United States)

    Pelavin Research Inst., Washington, DC.

    The Quality Assurance Program (QAP) workbook is intended to assist institutions of higher education conduct qualitative and quantitative evaluations of their financial aid operations in relation to requirements of Title IV of the Higher Education Act. The workbook provides a structured approach for incorporating a cyclical Title IV QA system into…

  15. Standard guide for establishing a quality assurance program for uranium conversion facilities

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2004-01-01

    1.1 This guide provides guidance and recommended practices for establishing a comprehensive quality assurance program for uranium conversion facilities. 1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate health and safety practices and determine the applicability of regulatory limitations prior to use. 1.3 The basic elements of a quality assurance program appear in the following order: FUNCTION SECTION Organization 5 Quality Assurance Program 6 Design Control 7 Instructions, Procedures & Drawings 8 Document Control 9 Procurement 10 Identification and Traceability 11 Processes 12 Inspection 13 Control of Measuring and Test Equipment 14 Handling, Storage and Shipping 15 Inspection, Test and Operating Status 16 Control of Nonconforming Items 17 Corrective Actions 18 Quality Assurance Records 19 Audits 20 TABLE 1 NQA-1 Basic Requirements Relat...

  16. Factors affecting the adoption of quality assurance technologies in healthcare.

    Science.gov (United States)

    Storey, John

    2013-01-01

    In the light of public concern and of strong policy emphasis on quality and safety in the nursing care of patients in hospital settings, this paper aims to focus on the factors affecting the adoption of innovative quality assurance technologies. Two sets of complementary literature were mined for key themes. Next, new empirical insights were sought. Data gathering was conducted in three phases. The first involved contact with NHS Technology Hubs and other institutions which had insights into leading centres in quality assurance technologies. The second phase was a series of telephone interviews with lead nurses in those hospitals which were identified in the first phase as comprising the leading centres. The third phase comprised a series of face to face interviews with innovators and adopters of healthcare quality assurance technologies in five hospital trusts. There were three main sets of findings. First, despite the strong policy push and the templates established at national level, there were significant variations in the nature and robustness of the quality assurance toolkits that were developed, adapted and adopted. Second, in most of the adopting cases there were important obstacles to the full adoption of the toolkits that were designed. Third, the extent and nature of the ambition of the developers varied dramatically - some wished to see their work impacting widely across the health service; others had a number of different reasons for wanting to restrict the impact of their work. The general concerns about front-line care and the various inquiries into care quality failures emphasise the need for improved and consistent care quality assurance methodologies and practice. The technology adoption literature gives only partial insight into the nature of the challenges; this paper offers specific insights into the factors inhibiting the full adoption of quality assurance technologies in ward-based care.

  17. Unresolved clinical aspects and safety hazards of blood derived- EV/MV in stored blood components: From personal memory lanes to newer perspectives on the roles of EV/MV in various biological phenomena.

    Science.gov (United States)

    Seghatchian, Jerard; Amiral, Jean

    2016-08-01

    Blood cells generate heterogeneous populations of vesicles that are delivered, as small-specialized packages of highly active cell fragments in blood circulation, having almost similar functional activities, as the mother cells. These so called extracellular vesicles are the essential part of an energy-dependent natural apoptotic process; hence their beneficial and harmful biological functions cannot be ignored. Evidence is accumulating, that cellular derived vesicles, originate from all viable cells including: megakaryocytes, platelets, red blood cells, white blood cells and endothelial cells, the highest in proportions from platelets. Shedding can also be triggered by pathological activation of inflammatory processes and activation of coagulation or complement pathways, or even by shear stress in the circulation. Structurally, so called MV/EV appear to be, sometimes inside-out and sometimes outside-in cell fragments having a bilayered phospholipid structure exposing coagulant-active phosphatidylserine, expressing various membrane receptors, and they serve as cell-to-cell shuttles for bioactive molecules such as lipids, growth factors, microRNAs, and mitochondria. Ex vivo processing of blood into its components, embodying centrifugation, processing by various apheresis procedures, leukoreduction, pathogen reduction, and finally storage in different media and different types of blood bags, also have major impacts on the generation and retention of MV content. These artificially generated small, but highly liable packages, together with the original pool of MVs collected from the donor, do exhibit differing biological activities, and are not inert elements and should be considered as a parameter of blood safety in haemovigilance programmes. Harmonization and consensus in sampling protocols, sample handling, processing, and assessment methods, in particular converting to full automation, are needed to achieve consensual interpretations. This review focuses on some of

  18. SU-E-T-05: 4D Measurement-Guided Dose Reconstruction (4D-MGDR) in End-End Quality Assurance (E2E QA) for Assessing Safety Margin in Radiosurgery (SRS) From Clinical Perspectives

    Energy Technology Data Exchange (ETDEWEB)

    Chan, M; Leung, R; Wong, M; Lee, V; Law, G; Lee, K; Tung, S [Tuen Mun Hospital, Hong Kong (China); Blanck, O [University Clinic Schleswig-Holstein, Kiel (Germany)

    2015-06-15

    Purpose: To assess the plan robustness and safety margin in SRS from 4DMGDR in E2E QA based on clinical objectives. Methods: OCTAVIUS SRS 1000 detector array and 4D phantom (PTW, Freiburg, Germany) were used to measure 5 coplanar SRS plans with 1 and 2 mm planning target volume (PTV). 3 targets were clinical, and 2 were virtual simulated to be 1mm from the brainstem (BS), and between chiasm (CS) and optic nerve (ON). Planning was done on Monaco v5.0 (Elekta, Maryland Heights, MO) to achieve 95–99% PTV and 100% gross tumor volume (GTV) prescription dose coverage. CBCT setup of the 4D phantom by 6D robotic couch was performed as for real patient. 4D-MGDR in patient CT and dosimetric analysis were performed in PTW Verisoft v6.1. The safety margin that achieved 100% GTV coverage was determined, and doses to 2% (D2%) of BS, ON and CS were assessed from E2E QA. Results: 100% GTV coverage was achieved with 1mm margin for 2 plans and 2mm margin for all plans. 98.3% and 99.4% GTV coverage were found in E2E QA for 1mm PTVs that either had sharp changing contour, or was nearby CS and ON or BS, and had either low planned minimum GTV dose (∼101% of the prescribed dose vs.∼106%) or compromised PTV coverage (95% vs. 99%). D2% to CS obtained with 4D-MGDR for one virtual target were 18.8Gy for 1mm PTV and 19.2Gy for 2mm PTV, exceeding the planned tolerance of 18Gy/3 fractions for prescription dose of 24Gy. Conclusion: 1mm margin is generally sufficient for dose planning and machine delivery errors. Irregular GTV with just enough dose coverage to spare critical organs may need 2mm margin at the costs of possible higher organ doses. 4D MGDR in an E2E QA approach can put the treatment plan evaluation in clinical perspectives.

  19. Accreditation and Quality Assurance: The Swiss Model.

    Science.gov (United States)

    Schenker-Wicki, Andrea

    2002-01-01

    Describes the establishment of Switzerland's Accreditation and Quality Assurance Board for higher education. Its advantages include that it focuses not only on fulfilling minimum standards through accreditation, but also on implementation of quality assurance mechanisms. (EV)

  20. Quality assurance - how to involve the employees

    DEFF Research Database (Denmark)

    Jørgensen, Michael Søgaard

    1996-01-01

    An overview of strategies for involvement of employees in quality assurance developement and implementation.......An overview of strategies for involvement of employees in quality assurance developement and implementation....

  1. Efficacy and safety of Chinese herbal medicine for chronic prostatitis associated with damp-heat and blood-stasis syndromes: a meta-analysis and literature review

    Directory of Open Access Journals (Sweden)

    Wang Z

    2016-09-01

    Full Text Available Zhiqiang Wang,1 Lei Yuan,1 Yongchuan Wang,2 Baizhi Yang,1 Xiaohong Dong,1 Zhaowang Gao3 1Department of Urology, Shouguang Hospital of Traditional Chinese Medicine, Shouguang, 2Department of Urology, Weifang Traditional Chinese Hospital, Weifang, 3Department of Urology, Shandong University of Traditional Chinese Medicine Affiliated Hospital, Shandong, People’s Republic of China Objective: The aim of this meta-analysis and systematic review is to evaluate the safety and efficacy of Chinese herbal medicine (CHM for chronic prostatitis (CP associated with damp-heat and blood-stasis syndromes.Methods: An electronic search of 13 databases up to May 2016 was screened to identify randomized controlled trials comparing the safety and efficacy of CHM for the treatment of CP associated with damp-heat and blood-stasis syndromes. Studies reporting on effective rates, adverse events, National Institutes of Health chronic prostatitis symptom index (NIH-CPSI scores, and symptom index of Chinese medicine for chronic prostatitis (SI-CM scores as outcomes were included in the analysis. Data were analyzed by fixed- or random-effect models using the Review Manager software.Results: Thirteen articles with the modified Jadad score ≥4 were identified. It was found that CHM was superior to placebo in increasing the efficacy (odds ratio: 6.72, 95% confidence interval [CI]: 2.78–9.48, P<0.00001 and reducing the SI-CM scores (standardized mean difference: -1.08, 95% CI: -1.35 to -0.81, P<0.00001. Oral CHMs were significantly more effective than placebo at reducing NIH-CPSI scores, with a mean difference of -1.39 (95% CI: -1.87 to -0.92, P<0.00001. Nevertheless, no significant differences were found between Prostant and placebo (standardized mean difference: -0.23, 95% CI: -0.46 to 0.01, P=0.06. The frequency of adverse events associated with oral CHM was similar to that associated with placebo (risk ratio: 1.36, 95% CI: 0.72–2.55, P=0.34 and less than that

  2. Legacy Management CERCLA Sites. Quality Assurance Project Plan

    Energy Technology Data Exchange (ETDEWEB)

    Riddle, Donna L.

    2007-05-03

    S.M. Stoller Corporation is the contractor for the Technical Assistance Contract (TAC) for the U.S. Department of Energy (DOE) Office of Legacy Management (LM) operations. Stoller employs a management system that applies to all programs, projects, and business management systems funded through DOE-LM task orders. The management system incorporates the philosophy, policies, and requirements of health and safety, environmental compliance, and quality assurance (QA) in all aspects of project planning and implementation. Health and safety requirements are documented in the Health and Safety Manual (STO 2), the Radiological Control Manual (STO 3), the Integrated Safety Management System Description (STO 10), and the Drilling Health and Safety Requirements (STO 14). Environmental compliance policy and requirements are documented in the Environmental Management Program Implementation Manual (STO 11). The QA Program is documented in the Quality Assurance Manual (STO 1). The QA Manual (STO 1) implements the specific requirements and philosophy of DOE Order 414.1C, Quality Assurance. This manual also includes the requirements of other standards that are regularly imposed by customers, regulators, or other DOE orders. Title 10 Code of Federal Regulations Part 830, “Quality Assurance Requirements,” ANSI/ASQC E4-2004, “Quality Systems for Environmental Data and Technology Programs – Requirements with Guidance for Use,” and ISO 14001-2004, “Environmental Management Systems,” have been included. These standards are similar in content. The intent of the QA Manual (STO 1) is to provide a QA management system that incorporates the requirements and philosophy of DOE and other customers within the QA Manual. Criterion 1, “Quality Assurance Program,” identifies the fundamental requirements for establishing and implementing the QA management system; QA Instruction (QAI) 1.1, “QA Program Implementation,” identifies the TAC organizations that have responsibility for

  3. Integrating quality assurance and research and development

    Energy Technology Data Exchange (ETDEWEB)

    Dronkers, J.J.

    1985-02-15

    Quality assurance programs cannot be transferred from one organization to another without attention to existing cultures and traditions. Introduction of quality assurance programs constitutes a significant change and represents a significant impact on the organizational structure and operational mode. Quality assurance professionals are change agents, but do not know how to be effective ones. Quality assurance as a body of knowledge and experience can only become accepted when its practitioners become familiar with their role as change agents. 8 references.

  4. Diagnosis of High Blood Pressure

    Medline Plus

    Full Text Available ... Science Science Home Blood Disorders and Blood Safety Sleep Science and Sleep Disorders Lung Diseases Heart and Vascular Diseases Precision ... normal for blood pressures to change when you sleep, wake up, or are excited or nervous. When ...

  5. Enhancing Transfusion Safety: Nurse’s Role

    Directory of Open Access Journals (Sweden)

    Kyriazi Vasiliki

    2011-01-01

    Full Text Available Background: Despite strict clinical measures, there are distinct steps in transfusion process which require acute attention.The nurse is responsible for insuring that the right unit is administered to the right patient. Knowledge of risks is essential toadminister and monitor transfusions safely.Aim: This study summarizes the available data concerning transfusion adverse events and provides theoretical and technicalaspects for improving transfusion practice.Methodology: A systematic review in PubMed, MedLine and MDConsult database was conducted. The research limitsincluded English texts, referring to transfusion risks and technological means aiming at transfusion safety.Results: Blood transfusion is a medical intervention that saves lives and improves the quality of life. The regulations forensuring the availability and assuring the quality of the blood component cannot avoid transfusion errors, placing patients atrisk. Most frequent errors are attributed to practitioners involved in the clinical transfusion process. Based on reports toSerious Hazards of Transfusion (SHOT the risk of transfusion error is estimated at 1:16,500. Over the last years severalcommittees have recommended guidance for enhancing the safety of blood ordering and administration. Moreover, newtechnology like barcode on patient wristband manages to improve the performance in each step.Conclusion: Safe transfusion process depends on a series of linked processes and nurses should take specific measuresreferring to pre- and post-transfusion stage. Technological innovations could help patients in need of transfusion therapy.

  6. [Quality assurance in cardiology: Germany].

    Science.gov (United States)

    Silber, S

    1996-10-01

    Quality assurance is a touchy subject: difficult to implement, time-demanding and expensive. The goal of quality assurance is to assist both the patients and the physicians. In addition to legal requirements, quality assurance is necessary for medical as well as economical reasons. It makes sense that the license to practice medicine does not automatically entail the right to perform all medical procedures; the development of new methods and the insights won from important scientific studies necessitates constant training. Furthermore, the decreasing allocation of funds for medical care combined with increased demand effected by new treatment methods and longer life expectancy force the development of instruments for specific and reasonable budgeting of medical expenditures. The primary goal of quality management in respect to economical regards must be the avoidance of unnecessary hospital admissions. But the patient must retain the right to choose the physician he prefers. The organization of the supervising structures in Germany is inconsistent: in 1995, a new Zentralstelle der Deutschen Arzteschaft zur Qualitätssicherung in der Medizin (German Physicians Headquarters for Quality Assurance in Medicine) was founded; it is proportionally staffed by representatives of the Bundesärztekammer (BAK, Federal Board of Physicians) and the Kassenärztliche Bundesvereinigung (KBV, Federal Commission of Panel Physicians). Furthermore, there is the Arbeitsgemeinschaft zur Förderung der Qualitätssicherung in der Medizin (Working Group for the Advancement of Quality Assurance in Medicine), in which the Bundesministerium für Gesundheit (Federal Ministry of Health) and the Kassenärztliche Vereinigung (KV, Public Health Insurance Providers) are represented. The KV is already seeing to it that stricter regulations govern physicians with private practice than those governing hospital physicians. There are three data banks existing on a voluntary basis for invasive diagnostic

  7. Solar consumer assurance network briefing book

    Energy Technology Data Exchange (ETDEWEB)

    Connor, Lynda

    1980-06-01

    Background information is provided on the rationale and purpose of the Solar Consumer Assurance Network (SOLCAN) program. Mechanisms being instituted by states to meet solar consumer assurance needs are identified. Mechanisms being developed with Federal government support to encourage solar consumer assurance activities are described. The operation of the FY 80 SOLCAN effort is described. (MHR)

  8. Blood Types

    Science.gov (United States)

    ... maternity. Learn About Blood Blood Facts and Statistics Blood Components Whole Blood and Red Blood Cells Platelets Plasma ... About Blood Blood Facts and Statistics Blood Types Blood Components What Happens to Donated Blood Blood and Diversity ...

  9. Patient Safety: What You Can Do to Be a Safe Patient

    Science.gov (United States)

    ... this? Submit What's this? Submit Button Additional CDC Patient Safety Websites Antibiotic / Antimicrobial Resistance Blood Safety Dialysis Safety ... Sepsis Sharps Safety - CDC Transplant Safety Vaccine Safety Patient Safety: What You Can Do to Be a Safe ...

  10. Therapeutic efficacy and safety of red blood cells treated with a chemical process (S-303) for pathogen inactivation: a Phase III clinical trial in cardiac surgery patients.

    Science.gov (United States)

    Benjamin, Richard J; McCullough, Jeffrey; Mintz, Paul D; Snyder, Edward; Spotnitz, William D; Rizzo, Robert J; Wages, David; Lin, Jin-Sying; Wood, Lindsey; Corash, Laurence; Conlan, Maureen G

    2005-11-01

    A randomized, double-blind trial is reported of the clinical efficacy of red blood cells (RBCs) treated for pathogen inactivation with S-303, a synthetic labile alkylating agent. Patients undergoing complex cardiac surgeries were randomly assigned to receive either S-303-treated (test) or conventional (control) RBC transfusion during surgery and for 6 days thereafter. Efficacy was evaluated by comparing the occurrence of a composite primary endpoint of treatment-related morbidity (myocardial infarction and renal failure) and mortality. Two-hundred twenty-three patients were randomly assigned and 148 patients who received transfusions (74 with S-303-treated RBCs and 74 with control RBCs) were evaluable. The incidence of the primary endpoint was equivalent between the two groups (22 and 21% in the S-303-treated and control RBC groups, respectively). Secondary endpoints, including hemoglobin increment (mean, 1.4 vs. 1.5 g/dL), number of RBC transfusions (mean, 4.4 vs. 3.8 units), and other blood product support, were also comparable. The adverse event profile was similar between groups; however, patients who received S-303 RBCs were significantly more likely to develop constipation and less likely to suffer supraventricular extrasystoles. Four patients (2 test and 2 control) demonstrated positive indirect antiglobulin tests with reactivity for S-303 RBCs at one or more time points before or after transfusion, without evidence of hemolysis. S-303-treated and conventional RBCs were equivalent with respect to clinical efficacy and safety in supporting the transfusion needs of cardiac surgery patients. Investigations are under way to ascertain the significance of S-303 RBC antibodies and to prevent their occurrence.

  11. Reevaluation of the utilization of arterial blood gas analysis in the Intensive Care Unit: effects on patient safety and patient outcome.

    Science.gov (United States)

    Blum, Franziska E; Lund, Elisa Takalo; Hall, Heather A; Tachauer, Allan D; Chedrawy, Edgar G; Zilberstein, Jeffrey

    2015-04-01

    Arterial blood gas (ABG) analysis is a useful tool to evaluate hypercapnia in the context of conditions and diseases affecting the lungs. Oftentimes, indications for ABG analysis are broad and nonspecific and lead to frequent testing without test results influencing patient management. Electronic charts of 300 intensive care unit (ICU) patients at a single institution were reviewed retrospectively. Reassessment of indications for ABGs led to a decrease of the number of ABGs in the ICU between March and November 2012. Data relating to ventilator days, length of stay, number of reintubations, mortality, complications after arterial puncture, demographics, and medications in 159 ICU patients between December 2011 and February 2012 (group 1) were compared with 141 ICU patients between December 2012 and February 2013 (group 2). Subgroup analysis in ventilated patients was performed. A decrease of number of ABGs per patient (6.12 ± 5.9, group 1 vs 2.03 ± 1.66, group 2 in ventilated patients; P = .007) was found along with a decrease in the number of ventilator days per patient (P = .004) and a shorter length of stay for ventilated patients in group 2 compared with group 1 (P = .04). A significant decrease of ABGs obtained in the ICU does not negatively impact patient outcome and safety. A decrease in the number of ABGs per patient allows cost-efficient patient care with a lower risk for complications. Copyright © 2014 Elsevier Inc. All rights reserved.

  12. UMTRA Project Office quality assurance program plan. Revision 6

    Energy Technology Data Exchange (ETDEWEB)

    1994-09-01

    The Uranium Mill Tailings Remedial Action (UMTRA) Project was established to accomplish remedial actions at inactive uranium mill tailings sites. The UMTRA Project`s mission is to stabilize and control the residual radioactive materials at designated sites in a safe and environmentally sound manner so as to minimize or eliminate radiation health hazards to the public. Because these efforts may involve possible risks to public health and safety, a quality assurance (QA) program that conforms to the applicable criteria has been established to control the quality of the work. This document, the Quality Assurance Program Plan (QAPP), brings into one document the essential criteria to be applied on a selective basis, depending upon the nature of the activity being conducted, and describes how those criteria shall be applied to the UMTRA Project. QA requirements contained in this QAPP shall apply to all personnel, processes, and activities, including planning, scheduling, and cost control, performed by the UMTRA Project Office and its contractors.

  13. Quality Interaction Between Mission Assurance and Project Team Members

    Science.gov (United States)

    Kwong-Fu, Helenann H.; Wilson, Robert K.

    2006-01-01

    Mission Assurance independent assessments started during the development cycle and continued through post launch operations. In operations, Health and Safety of the Observatory is of utmost importance. Therefore, Mission Assurance must ensure requirements compliance and focus on process improvements required across the operational systems including new/modified products, tools, and procedures. The deployment of the interactive model involves three objectives: Team member Interaction, Good Root Cause Analysis Practices, and Risk Assessment to avoid reoccurrences. In applying this model, we use a metric based measurement process and was found to have the most significant effect, which points to the importance of focuses on a combination of root cause analysis and risk approaches allowing the engineers the ability to prioritize and quantify their corrective actions based on a well-defined set of root cause definitions (i.e. closure criteria for problem reports), success criteria and risk rating definitions.

  14. Artificial Blood

    Directory of Open Access Journals (Sweden)

    Umit Yasar

    2012-04-01

    Full Text Available The problems and additional cost factor involved in collecting and storing human blood, as well as the pending worldwide shortages are the main driving forces in the development of blood substitutes. Studies on artificial blood basically aim to develop oxygen carrying compounds, produce stem cell-based erythrocyte cells in vitro and, implement the functions and movements of natural hemoglobin molecules found in erythrocyte cells through artificial erythrocyte cells. Consequently, major areas of research in artificial blood studies are haemoglobin-based oxygen carriers, perfluorochemicals, respirocytes and stem cells. Even though these artificial erythrocyte cells do not qualify as perfect red blood cell substitutes yet, they have many potential clinical and non clinical uses. Studies are being carried out on the elimination of side effects of blood substitutes and extensive clinical trials are being conducted to test their safety and efficacy. Artificial blood substitutes could only be used clinically for patient management following clinical trials and approvals, and will be the ultimate global solution to the problems associated with donor scarcity, blood collection and transfusion-mediated diseases. [Archives Medical Review Journal 2012; 21(2.000: 95-108

  15. Assurance of Fault Management: Risk-Significant Adverse Condition Awareness

    Science.gov (United States)

    Fitz, Rhonda

    2016-01-01

    Fault Management (FM) systems are ranked high in risk-based assessment of criticality within flight software, emphasizing the importance of establishing highly competent domain expertise to provide assurance for NASA projects, especially as spaceflight systems continue to increase in complexity. Insight into specific characteristics of FM architectures seen embedded within safety- and mission-critical software systems analyzed by the NASA Independent Verification Validation (IVV) Program has been enhanced with an FM Technical Reference (TR) suite. Benefits are aimed beyond the IVV community to those that seek ways to efficiently and effectively provide software assurance to reduce the FM risk posture of NASA and other space missions. The identification of particular FM architectures, visibility, and associated IVV techniques provides a TR suite that enables greater assurance that critical software systems will adequately protect against faults and respond to adverse conditions. The role FM has with regard to overall asset protection of flight software systems is being addressed with the development of an adverse condition (AC) database encompassing flight software vulnerabilities.Identification of potential off-nominal conditions and analysis to determine how a system responds to these conditions are important aspects of hazard analysis and fault management. Understanding what ACs the mission may face, and ensuring they are prevented or addressed is the responsibility of the assurance team, which necessarily should have insight into ACs beyond those defined by the project itself. Research efforts sponsored by NASAs Office of Safety and Mission Assurance defined terminology, categorized data fields, and designed a baseline repository that centralizes and compiles a comprehensive listing of ACs and correlated data relevant across many NASA missions. This prototype tool helps projects improve analysis by tracking ACs, and allowing queries based on project, mission

  16. Radiation Hardness Assurance (RHA) Guideline

    Science.gov (United States)

    Campola, Michael J.

    2016-01-01

    Radiation Hardness Assurance (RHA) consists of all activities undertaken to ensure that the electronics and materials of a space system perform to their design specifications after exposure to the mission space environment. The subset of interests for NEPP and the REAG, are EEE parts. It is important to register that all of these undertakings are in a feedback loop and require constant iteration and updating throughout the mission life. More detail can be found in the reference materials on applicable test data for usage on parts.

  17. Performance assurance for IT systems

    CERN Document Server

    King, Brian

    2004-01-01

    INDIVIDUAL AREAS OF INTERESTPreparing for the ChallengeAbstractIntroductionIn the BeginningThe Need to Address New ApplicationsDefinition of PerformanceThe Required SkillsPerformance Assurance Within a Project LifecycleSummaryCaveat Emptor (Let the Buyer Beware)AbstractSoftware Product LifecycleHardware Product LifecycleMarketingTechnical Reviews of ProductsLies, Damned Lies and BenchmarksAbstractIntroductionIndustry BenchmarksVendor BenchmarksIndependent BenchmarkingIn-House Benchmarking""Tricks of the Trade""Using Benchmarks Non-Functional Requirements and SolutionsAbstractIntroductionThe Pr

  18. Quality and safety in radiotherapy

    CERN Document Server

    Pawlicki, Todd

    2010-01-01

    The first text to focus solely on quality and safety in radiotherapy, this work encompasses not only traditional, more technically oriented, quality assurance activities, but also general approaches of quality and safety. It includes contributions from experts both inside and outside the field to present a global view. The task of assuring quality is no longer viewed solely as a technical, equipment-dependent endeavor. Instead, it is now recognized as depending on both the processes and the people delivering the service. Divided into seven broad categories, the text covers: Quality Management

  19. 49 CFR 385.311 - What will the safety audit consist of?

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false What will the safety audit consist of? 385.311... SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.311 What will the safety audit consist of? The safety audit will consist of a review of the new entrant's safety management systems and a...

  20. A systematic approach and tool support for GSN-based safety case assessment

    NARCIS (Netherlands)

    Luo, Y.; Brand, M. van den; Li, Z.; Saberi, A.K.

    2017-01-01

    Context. In safety-critical domains, safety cases are widely used to demonstrate the safety of systems. A safety case is an argumentation for showing confidence in the claimed safety assurance of a system, which should be comprehensible and well-structured. Typically, safety cases can be represented

  1. Trends in Area of Safety Communications within Industrial Networks

    Directory of Open Access Journals (Sweden)

    Maria Franekova

    2005-01-01

    Full Text Available The paper deals with the problems of safety communication in industrial networks for purpose of assurance of functional safety. It is intents on analysis of treats on industry networks and there is described recommended safety protections and their location into layer communication protocol applicable in fieldbus network, which they are used within safety critical processes control.

  2. Building quality into performance and safety assessment software

    Energy Technology Data Exchange (ETDEWEB)

    Wojciechowski, L.C. [Atomic Energy of Canada Limited, Pinawa, MB (Canada)

    2011-07-01

    Quality assurance is integrated throughout the development lifecycle for performance and safety assessment software. The software used in the performance and safety assessment of a Canadian deep geological repository (DGR) follows the CSA quality assurance standard CSA-N286.7 [1], Quality Assurance of Analytical, Scientific and Design Computer Programs for Nuclear Power Plants. Quality assurance activities in this standard include tasks such as verification and inspection; however, much more is involved in producing a quality software computer program. The types of errors found with different verification methods are described. The integrated quality process ensures that defects are found and corrected as early as possible. (author)

  3. HASP - The High Assurance Security Program

    OpenAIRE

    Naval Postgraduate School (U.S.); Center for Information Systems Studies Security and Research (CISR)

    2011-01-01

    This program provides a unifying conceptual framework and management structure for long range planning and coordination of focused Information Assurance research projects. The primary program goal is to support the strengthening of assurance provided by the National Information Infrastructure. Our approach includes the research and development of high assurance networks, systems, components and tools, and the open dissemination of outputs from those efforts, such as code and documentation.

  4. Assuring health and safety performance on construction projects ...

    African Journals Online (AJOL)

    Mr. Innocent Musonda, Senior Lecturer, ,Department of Construction Management ... dangerous workplaces, because of the high incidence of accidents ..... Ave = 6.60. SD. = 0.34. Commitment. Involvement. Competence. Leadership. 7.00. 6.00. 5.00. 4.00. 3.00. 2.00. 1.00. 0.00. On designers. On contractor top management.

  5. Model-Based Assurance Case+ (MBAC+): Tutorial on Modeling Radiation Hardness Assurance Activities

    Science.gov (United States)

    Austin, Rebekah; Label, Ken A.; Sampson, Mike J.; Evans, John; Witulski, Art; Sierawski, Brian; Karsai, Gabor; Mahadevan, Nag; Schrimpf, Ron; Reed, Robert A.

    2017-01-01

    This presentation will cover why modeling is useful for radiation hardness assurance cases, and also provide information on Model-Based Assurance Case+ (MBAC+), NASAs Reliability Maintainability Template, and Fault Propagation Modeling.

  6. Oxygen safety

    Science.gov (United States)

    COPD - oxygen safety; Chronic obstructive pulmonary disease - oxygen safety; Chronic obstructive airways disease - oxygen safety; Emphysema - oxygen safety; Heart failure - oxygen-safety; Palliative care - oxygen safety; Hospice - oxygen safety

  7. Medical Devices; General Hospital and Personal Use Devices; Classification of the Image Processing Device for Estimation of External Blood Loss. Final order.

    Science.gov (United States)

    2017-12-20

    The Food and Drug Administration (FDA or we) is classifying the image processing device for estimation of external blood loss into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the image processing device for estimation of external blood loss' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

  8. [Food safety of GMOs].

    Science.gov (United States)

    Joudrier, P

    2009-01-01

    In this presentation, we review the complexity of the different biological events which occur during life cell cycles. Indeed transgenesis is not an unknown event for cells. In the second part of this article, the complex and complete evaluation process destined to assure the food safety of GMOs, before they are released on the market, is describd. Some ansers to questions frequently asked about the GMOs are given. It is concludedthat GMOs are probably more safe than their conventional non-GM counterpart.

  9. Quality assurance requirements for dedication process in Angra 1

    Energy Technology Data Exchange (ETDEWEB)

    Baliza, Ana Rosa, E-mail: baliza@eletronuclear.gov.br [Eletrobras Termonuclear S.A. (ELETRONUCLEAR), Angra dos Reis, RJ (Brazil). Departamento GQO.G; Morghi, Youssef, E-mail: ymo@cdtn.br [Centro de Desenvolvimento da Tecnologia Nuclear (CDTN/CNEN-MG), Belo Horizonte, MG (Brazil)

    2015-07-01

    In Brazil the regulatory body is CNEN (Comissao Nacional de Energia Nuclear), according to its requirements, when there is not a Brazilian standard, the utilities shall follow the requirements of the designer. For Angra 1, the designer is an American company - Westinghouse. So, the requirements for dedication of U.S. NRC (United States Nuclear Regulatory Commission) shall be applied, these requirements are in 10CFR21 - Reporting of Defects and Noncompliance. According to 10CFR21, when applied to nuclear power plants licensed dedication is an acceptance process undertaken to provide reasonable assurance that a commercial grade item to be used as a basic component will perform its intended safety function and, in this respect, is deemed equivalent to an item designed and manufactured under a quality assurance program standard for nuclear power plant. This assurance is achieved by identifying the critical characteristics of the item and verifying their acceptability by inspections, tests, or analyses by the purchaser or third-party dedicating entity. (author)

  10. Quality assurance and statistical control

    DEFF Research Database (Denmark)

    Heydorn, K.

    1991-01-01

    In scientific research laboratories it is rarely possible to use quality assurance schemes, developed for large-scale analysis. Instead methods have been developed to control the quality of modest numbers of analytical results by relying on statistical control: Analysis of precision serves...... to detect analytical errors by comparing the a priori precision of the analytical results with the actual variability observed among replicates or duplicates. The method relies on the chi-square distribution to detect excess variability and is quite sensitive even for 5-10 results. Interference control...... through the origo. Calibration control is an essential link in the traceability of results. Only one or two samples of pure solid or aqueous standards with accurately known content need to be analyzed. Verification is carried out by analyzing certified reference materials from BCR, NIST, or others...

  11. Assured information flow capping architecture

    Science.gov (United States)

    Black, M. D.; Carvin, N. A.

    1985-05-01

    The Tactical Air Control System (TACS) is that set of Tactical Air Force assets used to assess the air and ground situation, and to plan, allocate, commit, and control assigned resources. Previous studies noted that the TACS elements should be more highly distributed to improve survivability in the battlefield of the future. This document reports on the results of the Assured Information Flow Capping Architecture study, which developed governing concepts for communications architectures that can support the information flow requirements of a future, distributed TACS. Architecture comprising existing and planned communications equipment were postulated and compared with a set of goals to identify deficiencies. Architectures using new equipment that resolve many of the deficiencies were then postulated, and areas needing further investigation were identified.

  12. Islay development flow assurance challenges

    Energy Technology Data Exchange (ETDEWEB)

    Helingoe, Mark; Greder, Hugues

    2010-07-01

    The Islay field is located in the Northern North Sea UK sector in the vicinity of the Alwyn Platforms. This gas condensate Brent structure is planned to be developed subsea with first gas in 2011. The main development challenge for this HPHT field comes from the early expected formation water production which is the source of major hydrate related flow assurance issues. As continuous inhibition is not feasible, Total has progressed a development scenario based on seabed conditioning prior to pipe laying so that water can be collected and temporarily inhibited at specific low points after a shut-down. It is also intended to heat trace the pipeline as a back-up solution to avoid hydrate formation. Heat tracing has so far never been implemented in Subsea developments. The Islay pilot could open the path to a new hydrate management philosophy for future developments. (Author)

  13. 20 CFR 655.1306 - Assurances and obligations of H-2A Labor Contractors.

    Science.gov (United States)

    2010-04-01

    ... OF LABOR TEMPORARY EMPLOYMENT OF FOREIGN WORKERS IN THE UNITED STATES Labor Certification Process for Temporary Agricultural Employment in the United States (H-2A Workers) § 655.1306 Assurances and obligations..., or local laws and regulations and will provide, at a minimum, the same vehicle safety standards...

  14. European perspectives of food safety.

    Science.gov (United States)

    Bánáti, Diána

    2014-08-01

    Food safety has been a growing concern among European Union (EU) citizens over the last decades. Despite the fact that food has never been safer, consumers are considerably uncertain and increasingly critical about the safety of their food. The introduction of new principles, such as the primary responsibility of producers, traceability, risk analysis, the separation of risk assessment and risk management provided a more transparent, science-based system in Europe, which can help to restore consumers' lost confidence. The present EU integrated approach to food safety 'from farm to fork' aims to assure a high level of food safety within the EU. © 2014 Society of Chemical Industry.

  15. Quality Assurance Program and Brain Drain

    Science.gov (United States)

    Lien, Donald

    2008-01-01

    The number of colleges and universities in most developing countries has increased drastically over the past decades. The quality variation of these institutions is an alarming concern. Quality assurance programs are proposed and implemented. This paper evaluates the effects of quality assurance on the demand for college education, study abroad,…

  16. 40 CFR 194.22 - Quality assurance.

    Science.gov (United States)

    2010-07-01

    ... Department shall adhere to a quality assurance program that implements the requirements of ASME NQA-1-1989 edition, ASME NQA-2a-1990 addenda, part 2.7, to ASME NQA-2-1989 edition, and ASME NQA-3-1989 edition...); corroborating data; confirmatory testing; or a quality assurance program that is equivalent in effect to ASME...

  17. Quality assurance manual: Volume 2, Appendices

    Energy Technology Data Exchange (ETDEWEB)

    Oijala, J.E.

    1988-06-01

    This paper contains quality assurance information on departments of the Stanford Linear Accelerator Center. Particular quality assurance policies and standards discussed are on: Mechanical Systems; Klystron and Microwave Department; Electronics Department; Plant Engineering; Accelerator Department; Purchasing; and Experimental Facilities Department. (LSP)

  18. Hungary Higher Education Quality Assurance System

    Directory of Open Access Journals (Sweden)

    Che Ru-shan

    2013-07-01

    Full Text Available Higher education quality assurance system has drawn much attention since 1980s. Most countries are committed to build the higher education quality assurance system to meet international standards. Under such an international trend, Hungary also actively promotes higher education reform, and established Hungarian Accreditation Committee and in order to ensure the quality of higher education.

  19. 40 CFR 30.54 - Quality assurance.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Quality assurance. 30.54 Section 30.54 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GRANTS AND OTHER FEDERAL ASSISTANCE UNIFORM... NON-PROFIT ORGANIZATIONS Post-Award Requirements Reports and Records § 30.54 Quality assurance. If the...

  20. Endorsing good quality assurance practices in molecular pathology: risks and recommendations for diagnostic laboratories and external quality assessment providers.

    Science.gov (United States)

    Tembuyser, Lien; Dequeker, Elisabeth M C

    2016-01-01

    Quality assurance is an indispensable element in a molecular diagnostic laboratory. The ultimate goal is to warrant patient safety. Several risks that can compromise high quality procedures are at stake, from sample collection to the test performed by the laboratory, the reporting of test results to clinicians, and the organization of effective external quality assessment schemes. Quality assurance should therefore be safeguarded at each level and should imply a holistic multidisciplinary approach. This review aims to provide an overview of good quality assurance practices and discusses certain risks and recommendations to promote and improve quality assurance for both diagnostic laboratories and for external quality assessment providers. The number of molecular targets is continuously rising, and new technologies are evolving. As this poses challenges for clinical implementation and increases the demand for external quality assessment, the formation of an international association for improving quality assurance in molecular pathology is called for.

  1. Failure mode and effect analysis in blood transfusion: a proactive tool to reduce risks.

    Science.gov (United States)

    Lu, Yao; Teng, Fang; Zhou, Jie; Wen, Aiqing; Bi, Yutian

    2013-12-01

    The aim of blood transfusion risk management is to improve the quality of blood products and to assure patient safety. We utilize failure mode and effect analysis (FMEA), a tool employed for evaluating risks and identifying preventive measures to reduce the risks in blood transfusion. The failure modes and effects occurring throughout the whole process of blood transfusion were studied. Each failure mode was evaluated using three scores: severity of effect (S), likelihood of occurrence (O), and probability of detection (D). Risk priority numbers (RPNs) were calculated by multiplying the S, O, and D scores. The plan-do-check-act cycle was also used for continuous improvement. Analysis has showed that failure modes with the highest RPNs, and therefore the greatest risk, were insufficient preoperative assessment of the blood product requirement (RPN, 245), preparation time before infusion of more than 30 minutes (RPN, 240), blood transfusion reaction occurring during the transfusion process (RPN, 224), blood plasma abuse (RPN, 180), and insufficient and/or incorrect clinical information on request form (RPN, 126). After implementation of preventative measures and reassessment, a reduction in RPN was detected with each risk. The failure mode with the second highest RPN, namely, preparation time before infusion of more than 30 minutes, was shown in detail to prove the efficiency of this tool. FMEA evaluation model is a useful tool in proactively analyzing and reducing the risks associated with the blood transfusion procedure. © 2013 American Association of Blood Banks.

  2. Fault Management Architectures and the Challenges of Providing Software Assurance

    Science.gov (United States)

    Savarino, Shirley; Fitz, Rhonda; Fesq, Lorraine; Whitman, Gerek

    2015-01-01

    The satellite systems Fault Management (FM) is focused on safety, the preservation of assets, and maintaining the desired functionality of the system. How FM is implemented varies among missions. Common to most is system complexity due to a need to establish a multi-dimensional structure across hardware, software and operations. This structure is necessary to identify and respond to system faults, mitigate technical risks and ensure operational continuity. These architecture, implementation and software assurance efforts increase with mission complexity. Because FM is a systems engineering discipline with a distributed implementation, providing efficient and effective verification and validation (VV) is challenging. A breakout session at the 2012 NASA Independent Verification Validation (IVV) Annual Workshop titled VV of Fault Management: Challenges and Successes exposed these issues in terms of VV for a representative set of architectures. NASA's IVV is funded by NASA's Software Assurance Research Program (SARP) in partnership with NASA's Jet Propulsion Laboratory (JPL) to extend the work performed at the Workshop session. NASA IVV will extract FM architectures across the IVV portfolio and evaluate the data set for robustness, assess visibility for validation and test, and define software assurance methods that could be applied to the various architectures and designs. This work focuses efforts on FM architectures from critical and complex projects within NASA. The identification of particular FM architectures, visibility, and associated VVIVV techniques provides a data set that can enable higher assurance that a satellite system will adequately detect and respond to adverse conditions. Ultimately, results from this activity will be incorporated into the NASA Fault Management Handbook providing dissemination across NASA, other agencies and the satellite community. This paper discusses the approach taken to perform the evaluations and preliminary findings from the

  3. Reinforcing Quality Assurance in Romanian Higher Education

    Directory of Open Access Journals (Sweden)

    Ana-Maria Dima

    2010-07-01

    Full Text Available Since 1993, the quality assurance system in Romania has gained considerable experience. This experience was recently recognized in 2008 by the ENQA: European Association for Quality Assurance in Higher Education through the admission of ARACIS as a full member of EQAR: the European Quality Assurance Register. The Board of ENQA agreed to grant ARACIS’s full membership of ENQA for five years from 2 June 2009. This article explores the benefits of membership for the Romanian Agency for Quality Assurance in Higher Education – ARACIS, comparing to other regional and global quality assurance agencies networks. The common features and differences between ARACIS and other European agencies are questioned through the frameworks of ENQA and INQAAHE as a case study.

  4. A Validated Trichinella Digestion Assay and an Associated Sampling and Quality Assurance System for Use in Testing Pork and Horse Meat

    National Research Council Canada - National Science Library

    Forbes, Lorry B; Gajadhar, Alvin A

    1999-01-01

    A revised digestion method, developed for efficiency and quality assurance, was validated for the detection of Trichinella larvae in pork and horse meat to meet requirements for food safety testing...

  5. The National Heart, Lung, and Blood Institute Recipient Epidemiology and Donor Evaluation Study (REDS-III): A research program striving to improve blood donor and transfusion recipient outcomes

    Science.gov (United States)

    Kleinman, Steven; Busch, Michael P; Murphy, Edward L; Shan, Hua; Ness, Paul; Glynn, Simone A.

    2014-01-01

    Background The Recipient Epidemiology and Donor Evaluation Study -III (REDS-III) is a 7-year multicenter transfusion safety research initiative launched in 2011 by the National Heart, Lung, and Blood Institute. Study design The domestic component involves 4 blood centers, 12 hospitals, a data coordinating center, and a central laboratory. The international component consists of distinct programs in Brazil, China, and South Africa which involve US and in-country investigators. Results REDS-III is using two major methods to address key research priorities in blood banking/transfusion medicine. First, there will be numerous analyses of large “core” databases; the international programs have each constructed a donor/donation database while the domestic program has established a detailed research database that links data from blood donors and their donations, the components made from these donations, and data extracts from the electronic medical records of the recipients of these components. Secondly, there are more than 25 focused research protocols involving transfusion recipients, blood donors, or both that are either in progress or scheduled to begin within the next 3 years. Areas of study include transfusion epidemiology and blood utilization; transfusion outcomes; non-infectious transfusion risks; HIV-related safety issues (particularly in the international programs); emerging infectious agents; blood component quality; donor health and safety; and other donor issues. Conclusions It is intended that REDS-III serve as an impetus for more widespread recipient and linked donor-recipient research in the US as well as to help assure a safe and available blood supply in the US and in international locations. PMID:24188564

  6. Organizational Culture and Safety

    Science.gov (United States)

    Adams, Catherine A.

    2003-01-01

    '..only a fool perseveres in error.' Cicero. Humans will break the most advanced technological devices and override safety and security systems if they are given the latitude. Within the workplace, the operator may be just one of several factors in causing accidents or making risky decisions. Other variables considered for their involvement in the negative and often catastrophic outcomes include the organizational context and culture. Many organizations have constructed and implemented safety programs to be assimilated into their culture to assure employee commitment and understanding of the importance of everyday safety. The purpose of this paper is to examine literature on organizational safety cultures and programs that attempt to combat vulnerability, risk taking behavior and decisions and identify the role of training in attempting to mitigate unsafe acts.

  7. Have You Given Blood Lately?

    Science.gov (United States)

    ... Products For Consumers Home For Consumers Consumer Updates Have You Given Blood Lately? Share Tweet Linkedin Pin ... material and asked to self-defer if they have risk factors that may affect blood safety. Donors ...

  8. Diagnosis of High Blood Pressure

    Medline Plus

    Full Text Available ... and Blood Safety Sleep Science and Sleep Disorders Lung Diseases Heart and Vascular Diseases Precision Medicine Activities ... Sugary foods and beverages In the National Heart, Lung, and Blood Institute (NHLBI)-sponsored Hispanic Community Health ...

  9. Diagnosis of High Blood Pressure

    Medline Plus

    Full Text Available ... Science Home Blood Disorders and Blood Safety Sleep Science and Sleep Disorders Lung Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and ...

  10. Diagnosis of High Blood Pressure

    Medline Plus

    Full Text Available ... Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep Science and Sleep Disorders Lung Diseases Heart and Vascular ...

  11. Diagnosis of High Blood Pressure

    Medline Plus

    Full Text Available ... Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep Science and ... Science A-Z Grants & Training Grants and Training Home Policies and Guidelines Funding Opportunities and Contacts Training ...

  12. A randomized comparison of platinum chromium-based everolimus-eluting stents versus cobalt chromium-based Zotarolimus-Eluting stents in all-comers receiving percutaneous coronary intervention: HOST-ASSURE (harmonizing optimal strategy for treatment of coronary artery stenosis-safety & effectiveness of drug-eluting stents & anti-platelet regimen), a randomized, controlled, noninferiority trial.

    Science.gov (United States)

    Park, Kyung Woo; Kang, Si-Hyuck; Kang, Hyun-Jae; Koo, Bon-Kwon; Park, Byoung-Eun; Cha, Kwang Soo; Rhew, Jay Young; Jeon, Hui-Kyoung; Shin, Eun-Seok; Oh, Ju Hyeon; Jeong, Myung-Ho; Kim, Sanghyun; Hwang, Kyung-Kuk; Yoon, Jung-Han; Lee, Sung Yun; Park, Tae-Ho; Moon, Keon Woong; Kwon, Hyuck-Moon; Hur, Seung-Ho; Ryu, Jae-Kean; Lee, Bong-Ryul; Park, Yong Whi; Chae, In-Ho; Kim, Hyo-Soo

    2014-07-01

    This study sought to test whether the newly developed platinum chromium (PtCr)-based everolimus-eluting stent (EES) is noninferior to the cobalt chromium (CoCr)-based zotarolimus-eluting stent (ZES) in all-comers receiving percutaneous coronary intervention (PCI). PtCr provides improved radial strength, conformability, and visibility compared with the CoCr alloy, but PtCr-based stents have not been tested in a wide range of patients receiving PCI. Also, recent case series have raised the issue of longitudinal stent deformation (LSD) with newer drug-eluting stents. We randomly assigned 3,755 all-comers receiving PCI to PtCr-EES or CoCr-ZES. The primary outcome was target lesion failure (TLF) at 1-year post-PCI, defined as the composite of cardiac death, nonfatal target vessel-related myocardial infarction, and ischemia-driven target lesion revascularization. Post-hoc angiographic analysis was performed to qualitatively and quantitatively analyze LSD. At 1 year, TLF occurred in 2.9% and 2.9% of the population in the PtCr-EES and CoCr-ZES groups, respectively (superiority p = 0.98, noninferiority p = 0.0247). There were no significant differences in the individual components of TLF as well as the patient-oriented clinical outcome. Of 5,010 stents analyzed, LSD occurred in 0.2% and 0% in the PtCr-EES and CoCr-ZES groups, respectively (p = 0.104). There was no significant difference in post-deployment stent length ratio between the 2 stents (p = 0.352). At 1 year, PtCr-EES was noninferior to CoCr-ZES in all-comers receiving PCI. Although LSD was observed only in PtCr-EES, both the stent length ratio and the frequency of LSD were not significantly different between the 2 stent types, and PtCr-EES was not associated with adverse clinical outcomes. (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-SAfety & EffectiveneSS of Drug-ElUting Stents & Anti-platelet REgimen [HOST-ASSURE]; NCT01267734). Copyright © 2014 American College of Cardiology

  13. Medical Physics Challenges for the Implementation of Quality Assurance Programmes in Radiation Oncology.

    Science.gov (United States)

    Meghzifene, A

    2017-02-01

    The importance of quality assurance in radiation therapy, as well as its positive consequences on patient treatment outcome, is well known to radiation therapy professionals. In low- and middle-income countries, the implementation of quality assurance in radiation therapy is especially challenging, due to a lack of staff training, a lack of national guidelines, a lack of quality assurance equipment and high patient daily throughput. According to the International Atomic Energy Agency (IAEA) Directory of Radiotherapy Centres, the proportion of linear accelerators compared with Co-60 machines has increased significantly in recent years in low- and middle-income countries. However, this increase in the proportion of relatively more demanding technology is not always accompanied with the necessary investment in staff training and quality assurance. The IAEA provides supports to low- and middle-income countries to develop and strengthen quality assurance programmes at institutional and national level. It also provides guidance, through its publications, on quality assurance and supports implementation of comprehensive clinical audits to identify gaps and makes recommendations for quality improvement in radiation therapy. The new AAPM TG100 report suggests a new approach to quality management in radiation therapy. If implemented, it will lead to improved cost-effectiveness of radiation therapy in all income settings. Low- and middle-income countries could greatly benefit from this new approach as it will help direct their scarce resources to areas where they can produce the optimum impact on patient care, without compromising patient safety. Copyright © 2016. Published by Elsevier Ltd.

  14. NASA Electrical, Electronic and Electromechanical (EEE) Parts Assurance, An Overview

    Science.gov (United States)

    Label, Kenneth A.; Sampson, Michael J.

    2017-01-01

    This presentation will cover NASA Electrical, Electronic and Electromechanical (EEE) Parts Assurance Structure, NASA Electronic Parts and Packaging (NEPP) Program, NASA Electronic Parts Assurance Group (NEPAG), examples of assurance challenges, and future challenges.

  15. Incompatible blood transfusion: Challenging yet lifesaving in the management of acute severe autoimmune hemolytic anemia.

    Science.gov (United States)

    Das, Sudipta Sekhar; Zaman, Rafiq Uz; Safi, Mohammad

    2014-07-01

    Autoimmune hemolytic anemia (AIHA) is characterized by the production of autoantibodies directed against red cell antigens. Most patients of AIHA arrive in the emergency or out-patient department (OPD) with severe anemia requiring urgent blood transfusion. Here we share our experience of managing these patients with incompatible blood transfusions and suggest the minimal test required to assure patient safety. A total of 14 patients admitted with severe anemia, diagnosed with AIHA and requiring blood transfusion urgently were included in the study. A series of immunohematological investigations were performed to confirm the diagnosis and issue best match packed red blood cells (PRBC) to these patients. A total of 167 PRBC units were crossmatched for 14 patients of which 46 units (28%) were found to be best match ones and 26 (56.5%) of these units were transfused. A mean turn around time of 222 min was observed in issuing the "best match" blood. Severe hemolysis was observed in all patients with a median hemoglobin increment of 0.88 g/dl after each unit PRBC transfusion. Decision to transfuse in AIHA should be based on the clinical condition of the patient. No critical patient should be denied blood transfusion due to serological incompatibility. Minimum investigations such as direct antiglobulin test (DAT), antibody screening and autocontrol should be performed to ensure transfusion safety in patients. All transfusion services should be capable of issuing "best match" PRBCs in AIHA.

  16. [Quality assurance in food production in Europe according to ISO 90000 and HACCP (Hazard Analysis and Critical Control Points)].

    Science.gov (United States)

    Jouve, J L

    1996-12-01

    HACCP is intended to make food protection programs evolve from a mainly retrospective quality control toward a preventative quality assurance approach and to provide an increased confidence in food safety. In parallel, the continuous evolution of quality concepts in the food industry resulted in the development of quality systems and quality assurance techniques with regard to the EN 29,000 (ISO 9000) series of standards. Specific to the food industry, HACCP can be seen as a very effective method to prepare specific Safety Assurance Plans (cf. the quality assurance plan concept) within a quality systems approach (Jouve, 1993). By reference to ISO 8402, a Quality Assurance Plan (QAP) basically sets out "the specific quality practices, resources and sequence of activities relevant to a particular product, service, contract or project". Quality assurance plans are more particularly useful for projects relating to new products or processes and/or comprising inter-related tasks whose interaction may be complex. In addition, in contractual or regulatory situations, such plans can be used to demonstrate the supplier's capability to meet identified objectives, specification or standards. In the food industry, the management of safety is a critical and complex issue which fits very well in the scope of application of a specific QAP; it is also where the use of HACCP is otherwise recommended by priority.

  17. 49 CFR 385.315 - Where will the safety audit be conducted?

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false Where will the safety audit be conducted? 385.315... SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.315 Where will the safety audit be conducted? The safety audit will generally be conducted at the new entrant's business premises. ...

  18. 49 CFR 385.313 - Who will conduct the safety audit?

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false Who will conduct the safety audit? 385.313 Section... FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.313 Who will conduct the safety audit? An individual certified under the FMCSA regulations to perform safety audits will conduct the safety audit. ...

  19. Quality assurance in biomarker measurement.

    Science.gov (United States)

    Aitio, A; Apostoli, P

    1995-05-01

    Quality assurance (QA) concerns the validity of all the analytical processes (from collection of the samples to interpretation of the results). It is not an abstract concept but must be adapted to the different situations such as the different exposure levels, the different analytical methods, and the context of use (risk assessment procedures, research, routine determinations). The main requirements in QA programmes regard the control of all the known sources of preanalytical and analytical variations, while the instruments with which adequate QA can be implemented are the certified materials and the quality control programmes (quality manual, internal and external quality controls). Another important concept in QA is that measurements must be placed a different metrological levels: at the highest there are the methods (definitive, reference) to be used for assessing accuracy of routine methods. QA programmes should enable a grading of biomarkers (from experimental only to full evaluated) and of the laboratories in order to identify the significance of the test and to assess the level at which a laboratory could operate.

  20. Metrological assurance in radiochemical production

    Directory of Open Access Journals (Sweden)

    Yuliya A. Tadevosyan

    2017-01-01

    Full Text Available Introduction: Radiochemical production is one of the richest in terms of data for analytical control, high-quality implementation of which is impossible without using type approved reference materials (RMs. Industry-specific institutes used to satisfy the demand for RMs, many of which nowadays have ceased this type of activities due to various reasons. The paper in question covers problems of metrological support in radiochemical production caused by the lack of type approved RMs.Materials and methods: Technologies used for obtaining homogeneous reference material for radiochemical production are described. Methods and measuring instruments used for certifying RMs are listed.Results: Results of developing certified reference materials at Mayak Production Association are given. Examples of codeveloping RMs of triuranium octoxide and plutonium dioxide are provided.Discussion and conclusions: Assessment of the current situation in terms of provision of type approved RMs is given. The paper provides data on availability of raw material, quality of instrument and methodological base in order to create a reference material production site at Mayak Production Association. Results of step-by-step solutions to problems of metrological assurance in radiochemical production are presented. Research prospects of developing RMs for inductively coupled plasma mass spectrometry are outlined. An outlook is given and practical proposals are formulated in the paper. The proposals in question are related to the interaction between institutes and enterprises of the field in terms of developing type approved RMs. 

  1. [Quality assurance in acupuncture therapy].

    Science.gov (United States)

    Kubiena, G

    1996-04-01

    Quality assurance for acupuncture therapy requires a good basic and on-going training in both conventional western medicine as well as in the theory and practice of acupuncture, the ability to synthesize the patient's objective findings and subjective feelings, and honesty with the patient and towards oneself. Thus, based on the continuous critical evaluation of the objective and subjective parameters, the question of acupunture as the optimal form of therapy for this specific case is honestly answered and one has the courage to admit failures. With regard to the theory, surveys of the acupuncture literature show that a considerable improvement in quality and honesty is necessary. There is a lack of standardised experimental methods (e.g. 28 different placebos in 28 different studies!). Especially German acupuncture journals have a disturbed relation to failures. To hide or deny failures is of no benefit neither to acupuncture, science to the relationship between the physician and the patient since the practitioner must be able to rely on the information in the literature. Furthermore, one should be open minded to alternative methods even if this means to refer a patient to a colleague.

  2. SWiFT Software Quality Assurance Plan.

    Energy Technology Data Exchange (ETDEWEB)

    Berg, Jonathan Charles [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2016-01-01

    This document describes the software development practice areas and processes which contribute to the ability of SWiFT software developers to provide quality software. These processes are designed to satisfy the requirements set forth by the Sandia Software Quality Assurance Program (SSQAP). APPROVALS SWiFT Software Quality Assurance Plan (SAND2016-0765) approved by: Department Manager SWiFT Site Lead Dave Minster (6121) Date Jonathan White (6121) Date SWiFT Controls Engineer Jonathan Berg (6121) Date CHANGE HISTORY Issue Date Originator(s) Description A 2016/01/27 Jon Berg (06121) Initial release of the SWiFT Software Quality Assurance Plan

  3. A Concept of Operations for an Integrated Vehicle Health Assurance System

    Science.gov (United States)

    Hunter, Gary W.; Ross, Richard W.; Berger, David E.; Lekki, John D.; Mah, Robert W.; Perey, Danie F.; Schuet, Stefan R.; Simon, Donald L.; Smith, Stephen W.

    2013-01-01

    This document describes a Concept of Operations (ConOps) for an Integrated Vehicle Health Assurance System (IVHAS). This ConOps is associated with the Maintain Vehicle Safety (MVS) between Major Inspections Technical Challenge in the Vehicle Systems Safety Technologies (VSST) Project within NASA s Aviation Safety Program. In particular, this document seeks to describe an integrated system concept for vehicle health assurance that integrates ground-based inspection and repair information with in-flight measurement data for airframe, propulsion, and avionics subsystems. The MVS Technical Challenge intends to maintain vehicle safety between major inspections by developing and demonstrating new integrated health management and failure prevention technologies to assure the integrity of vehicle systems between major inspection intervals and maintain vehicle state awareness during flight. The approach provided by this ConOps is intended to help optimize technology selection and development, as well as allow the initial integration and demonstration of these subsystem technologies over the 5 year span of the VSST program, and serve as a guideline for developing IVHAS technologies under the Aviation Safety Program within the next 5 to 15 years. A long-term vision of IVHAS is provided to describe a basic roadmap for more intelligent and autonomous vehicle systems.

  4. Functional safety of health information technology.

    LENUS (Irish Health Repository)

    Chadwick, Liam

    2012-03-01

    In an effort to improve patient safety and reduce adverse events, there has been a rapid growth in the utilisation of health information technology (HIT). However, little work has examined the safety of the HIT systems themselves, the methods used in their development or the potential errors they may introduce into existing systems. This article introduces the conventional safety-related systems development standard IEC 61508 to the medical domain. It is proposed that the techniques used in conventional safety-related systems development should be utilised by regulation bodies, healthcare organisations and HIT developers to provide an assurance of safety for HIT systems. In adopting the IEC 61508 methodology for HIT development and integration, inherent problems in the new systems can be identified and corrected during their development. Also, IEC 61508 should be used to develop a healthcare-specific standard to allow stakeholders to provide an assurance of a system\\'s safety.

  5. Maintenance quality assurance peer exchange 2.

    Science.gov (United States)

    2009-04-01

    This report documents a comprehensive study of twenty three maintenance quality assurance : (MQA) programs throughout the United States and Canada. The policies and standards of : each program were synthesized to create a general assessment on the co...

  6. Customers’ Perception regarding Assurance of Bancassurance Channel

    Directory of Open Access Journals (Sweden)

    Choudhury Mousumi

    2016-12-01

    Full Text Available Bancassurance has evolved as a strong distribution channel in India. Bancassurance means that the insurance company and the bank come together to offer insurance products from the counter of the banks to the bank’s customer. The present study attempts to analyse customers’ perception regarding assurance of bancassurance channel in providing insurance-related services. The study also tries to find out the impact of various demographic variables on customers’ perception regarding assurance of bancassurance channel. The study finds that customers consider bancassurance channel having high assurance in providing insurance services. It is also found in the study that there is no significant association between the demographic variables considered in the study and customers’ perception regarding assurance of bancassurance channel.

  7. Assurance on sustainability reporting : An auditor's view

    NARCIS (Netherlands)

    Wallage, Philip

    2000-01-01

    This article discusses initial experiences with a new assurance service: the verification of sustainability reports providing assertions regarding financial, environmental, and social issues. For illustration purposes, references to the verification of The Shell Report 2000 are made. Because of the

  8. Distance Learning Centres and Administrators' Quality Assurance ...

    African Journals Online (AJOL)

    systems performance. Based on the results, the study recommends that: Educational administrators should recruit qualified academic staff to teach and perform commensurate with their wealth of professional experience and qualification. Keywords: Open and Distance Learning (ODL); Quality assurance; Nigeria.

  9. Blood transfusion exposure in Denmark and Sweden

    DEFF Research Database (Denmark)

    Kamper-Jørgensen, Mads; Edgren, Gustaf; Rostgaard, Klaus

    2009-01-01

    Although essential for the evaluation of blood transfusion safety, the prevalence of blood transfusion in the general population is not presently known. This study estimated the exposure to blood transfusion in the general Scandinavian population.......Although essential for the evaluation of blood transfusion safety, the prevalence of blood transfusion in the general population is not presently known. This study estimated the exposure to blood transfusion in the general Scandinavian population....

  10. Platform for High-Assurance Cloud Computing

    Science.gov (United States)

    2016-06-01

    PLATFORM FOR HIGH-ASSURANCE CLOUD COMPUTING CORNELL UNIVERSITY JUNE 2016 FINAL TECHNICAL REPORT APPROVED FOR PUBLIC...DATES COVERED (From - To) SEP 2011 – DEC 2015 4. TITLE AND SUBTITLE PLATFORM FOR HIGH-ASSURANCE CLOUD COMPUTING 5a. CONTRACT NUMBER 5b. GRANT NUMBER...09. 13. SUPPLEMENTARY NOTES 14. ABSTRACT Cornell’s MRC effort undertook to help the military leverage cloud computing (elasticity, better data

  11. Dose Assurance in Radiation Processing Plants

    DEFF Research Database (Denmark)

    Miller, Arne; Chadwick, K.H.; Nam, J.W.

    1983-01-01

    Radiation processing relies to a large extent on dosimetry as control of proper operation. This applies in particular to radiation sterilization of medical products and food treatment, but also during development of any other process. The assurance that proper dosimetry is performed at the radiat...... at the radiation processing plant can be obtained through the mediation of an international organization, and the IAEA is now implementing a dose assurance service for industrial radiation processing....

  12. LMFBR safety and sodium boiling

    Energy Technology Data Exchange (ETDEWEB)

    Hinkle, W.D.; Tschamper, P.M.; Fontana, M.H.; Henry, R.E.; Padilla, A. Jr.

    1978-01-01

    Within the U.S. Fast Breeder Reactor Safety R and D Work Breakdown Structure for Line of Assurance 2, Limit Core Damage, the influence of sodium boiling upon the progression and termination of accidents is being studied in loss of flow, transient overpower, loss of piping integrity, loss of shutdown heat removal system and local fault situations. The pertinent analytical and experimental results of this research to date are surveyed and compared with the requirements for demonstrating the effectiveness of this line of assurance. A discussion of specific technical issues concerned with sodium boiling and the need for future development work is also presented.

  13. [Blood transfusion and infectious diseases].

    Science.gov (United States)

    Hamaguchi, Isao

    2013-05-01

    Blood transfusion is essential in current medical treatment. In the era of selling blood, around 50% of recipients seemed to be infected by hepatitis virus. After the establishment of the blood donation system and many safety measures, the risk of blood contamination has decreased markedly; however, blood products still have a risk of known and unknown pathogens. In this manuscript, we discuss the remaining problems of HBV and HIV-1. As emerging infectious diseases, we examine Trypanosoma crusi, West Nile virus, Chikungunya virus, and Dengue virus. Finally, XMRV is exemplified as a rumored virus. Gathering accurate information about pathogens and preparing for outbreaks in advance are crucial for blood safety.

  14. Quality assurance in performance assessments

    Energy Technology Data Exchange (ETDEWEB)

    Maul, P.R.; Watkins, B.M.; Salter, P.; Mcleod, R [QuantiSci Ltd, Henley-on-Thames (United Kingdom)

    1999-01-01

    Following publication of the Site-94 report, SKI wishes to review how Quality Assurance (QA) issues could be treated in future work both in undertaking their own Performance Assessment (PA) calculations and in scrutinising documents supplied by SKB (on planning a repository for spent fuels in Sweden). The aim of this report is to identify the key QA issues and to outline the nature and content of a QA plan which would be suitable for SKI, bearing in mind the requirements and recommendations of relevant standards. Emphasis is on issues which are specific to Performance Assessments for deep repositories for radioactive wastes, but consideration is also given to issues which need to be addressed in all large projects. Given the long time over which the performance of a deep repository system must be evaluated, the demonstration that a repository is likely to perform satisfactorily relies on the use of computer-generated model predictions of system performance. This raises particular QA issues which are generally not encountered in other technical areas (for instance, power station operations). The traceability of the arguments used is a key QA issue, as are conceptual model uncertainty, and code verification and validation; these were all included in the consideration of overall uncertainties in the Site-94 project. Additionally, issues which are particularly relevant to SKI include: How QA in a PA fits in with the general QA procedures of the organisation undertaking the work. The relationship between QA as applied by the regulator and the implementor of a repository development programme. Section 2 introduces the discussion of these issues by reviewing the standards and guidance which are available from national and international organisations. This is followed in Section 3 by a review of specific issues which arise from the Site-94 exercise. An outline procedure for managing QA issues in SKI is put forward as a basis for discussion in Section 4. It is hoped that

  15. Formal Foundations for Hierarchical Safety Cases

    Science.gov (United States)

    Denney, Ewen; Pai, Ganesh; Whiteside, Iain

    2015-01-01

    Safety cases are increasingly being required in many safety-critical domains to assure, using structured argumentation and evidence, that a system is acceptably safe. However, comprehensive system-wide safety arguments present appreciable challenges to develop, understand, evaluate, and manage, partly due to the volume of information that they aggregate, such as the results of hazard analysis, requirements analysis, testing, formal verification, and other engineering activities. Previously, we have proposed hierarchical safety cases, hicases, to aid the comprehension of safety case argument structures. In this paper, we build on a formal notion of safety case to formalise the use of hierarchy as a structuring technique, and show that hicases satisfy several desirable properties. Our aim is to provide a formal, theoretical foundation for safety cases. In particular, we believe that tools for high assurance systems should be granted similar assurance to the systems to which they are applied. To this end, we formally specify and prove the correctness of key operations for constructing and managing hicases, which gives the specification for implementing hicases in AdvoCATE, our toolset for safety case automation. We motivate and explain the theory with the help of a simple running example, extracted from a real safety case and developed using AdvoCATE.

  16. The efficacy and safety of a proprietary onion-pumpkin extract (OPtain120 on blood pressure: an open-label study

    Directory of Open Access Journals (Sweden)

    Orie Yoshinari

    2015-06-01

    Full Text Available Background: Nutraceuticals and functional foods are increasingly being used to help manage hypertension. Treatment with either pumpkin or onion can significantly lower systolic and diastolic blood pressure in animal studies. Traditionally, pumpkin has been used to support healthy blood pressure, glucose tolerance and lipid levels. Onion contains high levels of flavonoids, including quercetin, which decreases blood pressure and promotes restoration of healthy endothelial function. However, human trials on these food sources are limited, and the combined effects of pumpkin and onion have not been examined yet. Objective: We performed an open-label clinical study to evaluate the effects of a proprietary onion-pumpkin extract (OPtain120 on systolic and diastolic blood pressure. Methods: Healthy adults with systolic blood pressure (SBP and diastolic blood pressure (DBP in the elevated range of 140-159 and 80-90 mmHg, respectively, were enrolled in this study. Subjects consumed one capsule of onion-pumpkin extract twice daily for 12 weeks. Daily Home Blood Pressure Measurement (HBPM was taken upon waking and before bed. Office Blood Pressure Measurement (OBPM was taken in-clinic at Week 0, 6, and 12. Results: 52 subjects were screened and 12 were enrolled in the study, with a total of 10 subjects completing the study. Systolic HBPM taken before bed demonstrated a statistically significant reduction from baseline (147.23 mmHg to Week 12 (138.14 mmHg, representing a reduction of 9.09 mmHg (6.17%, p=0.021. Diastolic HBPM taken before bed demonstrated a decrease of 4.06 mmHg (4.46%, p=0.085, a significant reduction from baseline (91.07 mmHg at Week 12 (87.02 mmHg. Non-statistically significant reductions were seen in the early morning Systolic (3.14% and Diastolic (2.57% HBPM and in the Systolic (1.36% OBPM. Conclusion: OPtain120 was safely consumed over a 12-week period. OPtain120 appears to be effective in lowering Systolic Blood Pressure at bedtime in

  17. [Blood glucose self monitoring].

    Science.gov (United States)

    Wascher, Thomas C; Stechemesser, Lars

    2016-04-01

    Self monitoring of blood glucose contributes to the integrated management of diabetes mellitus. It, thus, should be available for all patients with diabetes mellitus type-1 and type-2. Self monitoring of blood glucose improves patients safety, quality of life and glucose control. The current article represents the recommendations of the Austrian Diabetes Association for the use of blood glucose self monitoring according to current scientific evidence.

  18. Technical Reference Suite Addressing Challenges of Providing Assurance for Fault Management Architectural Design

    Science.gov (United States)

    Fitz, Rhonda; Whitman, Gerek

    2016-01-01

    Research into complexities of software systems Fault Management (FM) and how architectural design decisions affect safety, preservation of assets, and maintenance of desired system functionality has coalesced into a technical reference (TR) suite that advances the provision of safety and mission assurance. The NASA Independent Verification and Validation (IV&V) Program, with Software Assurance Research Program support, extracted FM architectures across the IV&V portfolio to evaluate robustness, assess visibility for validation and test, and define software assurance methods applied to the architectures and designs. This investigation spanned IV&V projects with seven different primary developers, a wide range of sizes and complexities, and encompassed Deep Space Robotic, Human Spaceflight, and Earth Orbiter mission FM architectures. The initiative continues with an expansion of the TR suite to include Launch Vehicles, adding the benefit of investigating differences intrinsic to model-based FM architectures and insight into complexities of FM within an Agile software development environment, in order to improve awareness of how nontraditional processes affect FM architectural design and system health management. The identification of particular FM architectures, visibility, and associated IV&V techniques provides a TR suite that enables greater assurance that critical software systems will adequately protect against faults and respond to adverse conditions. Additionally, the role FM has with regard to strengthened security requirements, with potential to advance overall asset protection of flight software systems, is being addressed with the development of an adverse conditions database encompassing flight software vulnerabilities. Capitalizing on the established framework, this TR suite provides assurance capability for a variety of FM architectures and varied development approaches. Research results are being disseminated across NASA, other agencies, and the

  19. The Evolution of the NASA Commercial Crew Program Mission Assurance Process

    Science.gov (United States)

    Canfield, Amy C.

    2016-01-01

    In 2010, the National Aeronautics and Space Administration (NASA) established the Commercial Crew Program (CCP) in order to provide human access to the International Space Station and low Earth orbit via the commercial (non-governmental) sector. A particular challenge to NASA has been how to determine that the Commercial Provider's transportation system complies with programmatic safety requirements. The process used in this determination is the Safety Technical Review Board which reviews and approves provider submitted hazard reports. One significant product of the review is a set of hazard control verifications. In past NASA programs, 100% of these safety critical verifications were typically confirmed by NASA. The traditional Safety and Mission Assurance (S&MA) model does not support the nature of the CCP. To that end, NASA S&MA is implementing a Risk Based Assurance process to determine which hazard control verifications require NASA authentication. Additionally, a Shared Assurance Model is also being developed to efficiently use the available resources to execute the verifications.

  20. The safety of peri-articular local anaesthetic injection for patients undergoing total knee replacement with autologous blood transfusion: a randomised trial.

    Science.gov (United States)

    Wallace, D F; Emmett, S R; Kang, K K; Chahal, G S; Hiskens, R; Balasubramanian, S; McGuinness, K; Parsons, H; Achten, J; Costa, M L

    2012-12-01

    Intra-operative, peri-articular injection of local anaesthesia is an increasingly popular way of controlling pain following total knee replacement. At the same time, the problems associated with allogenic blood transfusion have led to interest in alternative methods for managing blood loss after total knee replacement, including the use of auto-transfusion of fluid from the patient's surgical drain. It is safe to combine peri-articular infiltration with auto-transfusion from the drain. We performed a randomised clinical trial to compare the concentration of local anaesthetic in the blood and in the fluid collected in the knee drain in patients having either a peri-articular injection or a femoral nerve block. Clinically relevant concentrations of local anaesthetic were found in the fluid from the drains of patients having peri-articular injections (4.92 μg/ml (sd 3.151)). However, none of the patients having femoral nerve blockade had detectable levels. None of the patients in either group had clinically relevant concentrations of local anaesthetic in their blood after re-transfusion. The evidence from this study suggests that it is safe to use peri-articular injection in combination with auto-transfusion of blood from peri-articular drains during knee replacement surgery.

  1. Quality assurance in non-interventional studies

    Directory of Open Access Journals (Sweden)

    Capan, Müge

    2009-11-01

    Full Text Available Nowadays, drug research and surveillance after authorisation becomes more and more important for several reasons. Non-interventional studies (NIS investigate various aspects of drug use including efficacy and safety under real life conditions. Such kind of health services research should be on a high scientific, methodological and organisational level. Therefore accompanying measures to improve or to keep the quality are highly recommended. The aim of quality management is: first to avoid bias of results by using an appropriate study design and an adequate data analysis, second to assure authenticity, completeness and validity of the data and third to identify and resolve deficiencies at an early stage. Basic principles are laid down in corresponding guidelines and recommendations of authorities, institutes and societies. Various guidelines for good epidemiological practice (GEP were published by the U.S. Food and Drug Administration (FDA and international and regional societies for epidemiology. In addition in Germany the Federal Institute for Drugs and Medical Devices (BfArM together with the Paul Ehrlich Institute (PEI and the German Association of Research-Based Pharmaceutical Companies (VFA have published respectively recommendations dealing with quality aspects of non-interventional observational studies. Key points are the advanced publishing of information about the project, developing of a study plan/protocol containing the scientific objectives, a sample size justification and a description of the planned analyses and the publishing of a summary of the results timely after completion of the study. The quality of the data can be improved by using standardized case report forms (CRF and the CRF should be reviewed and tested before start of study by some participants. A source data verification (SDV should be performed in randomly selected centres – in between 2% and 5% of the centres depending on the number of participating centres

  2. 42 CFR 457.495 - State assurance of access to care and procedures to assure quality and appropriateness of care.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false State assurance of access to care and procedures to... State assurance of access to care and procedures to assure quality and appropriateness of care. A State... appropriateness of care provided under the plan, including how the State will assure: (a) Access to well-baby care...

  3. Automating linear accelerator quality assurance

    Energy Technology Data Exchange (ETDEWEB)

    Eckhause, Tobias; Thorwarth, Ryan; Moran, Jean M., E-mail: jmmoran@med.umich.edu [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan 48109-5010 (United States); Al-Hallaq, Hania; Farrey, Karl [Department of Radiation Oncology and Cellular Oncology, The University of Chicago, Chicago, Illinois 60637 (United States); Ritter, Timothy [Ann Arbor VA Medical Center, Ann Arbor, Michigan 48109 (United States); DeMarco, John [Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California, 90048 (United States); Pawlicki, Todd; Kim, Gwe-Ya [UCSD Medical Center, La Jolla, California 92093 (United States); Popple, Richard [Department of Radiation Oncology, University of Alabama Birmingham, Birmingham, Alabama 35249 (United States); Sharma, Vijeshwar; Park, SungYong [Karmanos Cancer Institute, McLaren-Flint, Flint, Michigan 48532 (United States); Perez, Mario; Booth, Jeremy T. [Royal North Shore Hospital, Sydney, NSW 2065 (Australia)

    2015-10-15

    Purpose: The purpose of this study was 2-fold. One purpose was to develop an automated, streamlined quality assurance (QA) program for use by multiple centers. The second purpose was to evaluate machine performance over time for multiple centers using linear accelerator (Linac) log files and electronic portal images. The authors sought to evaluate variations in Linac performance to establish as a reference for other centers. Methods: The authors developed analytical software tools for a QA program using both log files and electronic portal imaging device (EPID) measurements. The first tool is a general analysis tool which can read and visually represent data in the log file. This tool, which can be used to automatically analyze patient treatment or QA log files, examines the files for Linac deviations which exceed thresholds. The second set of tools consists of a test suite of QA fields, a standard phantom, and software to collect information from the log files on deviations from the expected values. The test suite was designed to focus on the mechanical tests of the Linac to include jaw, MLC, and collimator positions during static, IMRT, and volumetric modulated arc therapy delivery. A consortium of eight institutions delivered the test suite at monthly or weekly intervals on each Linac using a standard phantom. The behavior of various components was analyzed for eight TrueBeam Linacs. Results: For the EPID and trajectory log file analysis, all observed deviations which exceeded established thresholds for Linac behavior resulted in a beam hold off. In the absence of an interlock-triggering event, the maximum observed log file deviations between the expected and actual component positions (such as MLC leaves) varied from less than 1% to 26% of published tolerance thresholds. The maximum and standard deviations of the variations due to gantry sag, collimator angle, jaw position, and MLC positions are presented. Gantry sag among Linacs was 0.336 ± 0.072 mm. The

  4. Empowering Managers, Assuring Governors: The Introduction of Dual Assurance at the University of Exeter

    Science.gov (United States)

    Weale, Gillian

    2010-01-01

    Since the start of the academic session 2007-08, the University of Exeter has been operating a unique system of governance known as dual assurance, which has replaced a more traditional system of committees sitting under Council, the governing body. This paper describes the background to the development of dual assurance at Exeter, and the reasons…

  5. A Framework for Modeling the Software Assurance Ecosystem: Insights from the Software Assurance Landscape Project

    Science.gov (United States)

    2010-08-01

    by circles—are actors in the ecosystem that include assurance solutions, individuals, standards bodies , or organizations (e.g., commercial...technology (in general and for assurance)? What is the distinguishing feature of this technology? Identify any fields, disciplines, or bodies of...Acquisition Test and Integration Operations User Recomposition F5. System Orientation F6. Notes: System Orientation F7

  6. Documentation of Hanford Site independent review of the Hanford Waste Vitrification Plant Preliminary Safety Analysis Report

    Energy Technology Data Exchange (ETDEWEB)

    Herborn, D.I.

    1991-10-01

    The requirements for Westinghouse Hanford independent review of the Preliminary Safety Analysis Report (PSAR) are contained in Section 1.0, Subsection 4.3 of WCH-CM-4-46. Specifically, this manual requires the following: (1) Formal functional reviews of the HWVP PSAR by the future operating organization (HWVP Operations), and the independent review organizations (HWVP and Environmental Safety Assurance, Environmental Assurance, and Quality Assurance); and (2) Review and approval of the HWVP PSAR by the Tank Waste Disposal (TWD) Subcouncil of the Safety and Environmental Advisory Council (SEAC), which provides independent advice to the Westinghouse Hanford President and executives on matters of safety and environmental protection. 7 refs.

  7. Preliminary results of quality assurance implementation in interventional cardiology

    Energy Technology Data Exchange (ETDEWEB)

    Nikodemova, D. [Slovak Medical Univ., Bratislava (Slovakia)

    2006-07-01

    Full text of publication follows: The dramatic increase in the frequency of the interventional procedures reflects the significant benefit which directly affects the patient. However parallel is this benefit accompanied by some concern about the consequent increase in doses to patient and staff. The question of safety has prompted the European commission and Who to issue and advise to conduct research in the area of the intervention radiology and to prepare standard protocols for quality assurance of interventional procedures. The presentation is focused on the optimization of interventional procedures in cardiology with aim to reduce the risk level of high exposures and to elaborate national standard methods of quality assurance program, as well as, the procedures used for the case of overexposure. Study was conducted at Slovak Institute of Cardiology, as well as, at Slovak Pediatric Cardiology Center, where wide variation of specific interventional procedures are performed. Skin dose date of patient were measured by Unfors Patient Skin Dosemeter P.S.D. - 4 and the values of Dose area products followed during all examinations. All technical parameters used for examinations were identified. Simultaneously were measured the personal doses of the medical staff present by the examinations. For personal dose measurements Unfors E.D.D.30 dose meter was used, as well as, T.L.D. for measurements of doses on extremities. Preliminary results confirm wide spread of patient doses and professional doses of medical staff. The causes of this spread will by discussed. (authors)

  8. Quality assurance in functional MRI

    DEFF Research Database (Denmark)

    Liu, Thomas T; Glover, Gary H; Mueller, Bryon A

    2015-01-01

    Over the past 20 years, functional magnetic resonance imaging (fMRI) has ben- efited greatly from improvements in MRI hardware and software. At the same time, fMRI researchers have pushed the technical limits of MRI systems and greatly in- fluenced the development of state-of-the-art systems....... Minimizing image noise and maximizing system stability is critical in fMRI because the blood oxygenation level- dependent (BOLD) signal changes that are used for most fMRI studies represent only a small fraction of the total MR signal. In addition, multiple imaging volumes must be acquired over time to track...... cognitive processes. As a result, MRI scanners must have excellent time-series stability to accurately measure BOLD signal changes over the course of a long time series (typically on the order of 10 min per scan). fMRI studies are particularly demanding on the scanner hardware because they utilize fast...

  9. Regulatory and Safety Requirements for Food Cultures

    Directory of Open Access Journals (Sweden)

    Svend Laulund

    2017-05-01

    Full Text Available The increased use of food cultures to ferment perishable raw materials has potentiated the need for regulations to assess and assure the safety of food cultures and their uses. These regulations differ from country to country, all aimed at assuring the safe use of food cultures which has to be guaranteed by the food culture supplier. Here we highlight national differences in regulations and review a list of methods and methodologies to assess the safety of food cultures at strain level, at production, and in the final product.

  10. Quality Assurance Plan for the AL3 Test Procedure

    CERN Document Server

    Béjar-Alonso, Isabel

    1999-01-01

    This paper describes the new quality assurance plan for the Alarms-of-Level-3 (AL3) test. The aim of the plan is to introduce engineering techniques and to standardise and simplify the procedures for carrying out tests following Safety Instruction 37 (IS37). The procedures are to co-ordinate all the services involved (fire brigade, maintenance and computer support) and to create a consistent documentation. When the procedures are implemented, it will be possible to determine with confidence how field actions are carried out and to measure actual performance. The focus will be on personnel training and documentation. It is important however to keep documentation and procedures to a reasonable level that can be maintained at appropriate intervals. The plan is the result of an internal requirement from ST/MC and a formal request from Installations Nucléaires de Base (INB).

  11. Safety and Efficacy of Losartan 50 mg in Reducing Blood Pressure among Patients with Post-Dialysis Euvolemic Hypertension: A Randomized Control Trial.

    Science.gov (United States)

    Aftab, Raja Ahsan; Khan, Amer Hayat; Adnan, Azreen Syazril; Sulaiman, Syed Azhar Syed; Khan, Tahir Mehmood

    2017-12-18

    The aim of current study was to assess the effectiveness of losartan 50 mg in reducing blood pressure among post-dialysis euvolemic hypertensive patients, observing their survival trends and adverse events during the course of study. A multicentre, prospective, randomised, single-blind trial was conducted to assess the effect of losartan 50 mg every other day (EOD), once a morning (OM) among post-dialysis euvolemic hypertensive patients. Post-dialysis euvolemic assessment was done by a body composition monitor (BCM). Covariate Adaptive Randomization was used for allocation of participants to the standard or intervention arm. Of the total 229 patients, 96 (41.9%) were identified as post-dialysis euvolemic hypertensive. Final samples of 88 (40.1%) patients were randomized into standard and intervention arms. After follow-up of 12 months' pre-dialysis systolic (p < 0.001) and diastolic (p 0.01), intradialysis diastolic (p 0.02), post-dialysis systolic (p < 0.001) and diastolic (p < 0.001) blood pressure was reduced from the baseline among intervention-arm patients Compared to only pre-dialysis systolic blood pressure (p 0.003) among standard arm patients after 12 months of follow. Total of six deaths were reported among standard-arm patients compared to 2 deaths among the intervention arm. Losartan 50 mg achieve an overall significant decline in blood pressure among post-dialysis euvolemic hypertensive patients.

  12. IEEE Std 730 Software Quality Assurance: Supporting CMMI-DEV v1.3, Product and Process Quality Assurance

    Science.gov (United States)

    2011-05-27

    Architecture and Framework – CMMI ® for Acquisition, ACQ • 22 process areas – include process & product quality assurance, PPQA – CMMI ® for Services, SVC ...2011 Walz IEEE Std 730 Software Quality Assurance: Supporting CMMI -DEV v1.3, Product and Process Quality Assurance 1 John Walz 2012 President...Quality Assurance: Supporting CMMI -DEV v1.3, Product and Process Quality Assurance 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6

  13. Quality assurance and organizational effectiveness in hospitals.

    Science.gov (United States)

    Hetherington, R W

    1982-01-01

    The purpose of this paper is to explore some aspects of a general theoretical model within which research on the organizational impacts of quality assurance programs in hospitals may be examined. Quality assurance is conceptualized as an organizational control mechanism, operating primarily through increased formalization of structures and specification of procedures. Organizational effectiveness is discussed from the perspective of the problem-solving theory of organizations, wherein effective organizations are those which maintain at least average performance in all four system problem areas simultaneously (goal-attainment, integration, adaptation and pattern-maintenance). It is proposed that through the realization of mutual benefits for both professionals and the bureaucracy, quality assurance programs can maximize such effective performance in hospitals.

  14. Assuring quality in high-consequence engineering

    Energy Technology Data Exchange (ETDEWEB)

    Hoover, Marcey L.; Kolb, Rachel R.

    2014-03-01

    In high-consequence engineering organizations, such as Sandia, quality assurance may be heavily dependent on staff competency. Competency-dependent quality assurance models are at risk when the environment changes, as it has with increasing attrition rates, budget and schedule cuts, and competing program priorities. Risks in Sandia's competency-dependent culture can be mitigated through changes to hiring, training, and customer engagement approaches to manage people, partners, and products. Sandia's technical quality engineering organization has been able to mitigate corporate-level risks by driving changes that benefit all departments, and in doing so has assured Sandia's commitment to excellence in high-consequence engineering and national service.

  15. Diagnosis of High Blood Pressure

    Medline Plus

    Full Text Available ... Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep ... eating plan if you have high blood pressure. The DASH eating plan focuses on fruits, vegetables, whole grains, and other foods that are heart healthy ...

  16. Baseline Blood Pressure Effect on the Benefit and Safety of Intra-Arterial Treatment in MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands).

    Science.gov (United States)

    Mulder, Maxim J H L; Ergezen, Saliha; Lingsma, Hester F; Berkhemer, Olvert A; Fransen, Puck S S; Beumer, Debbie; van den Berg, Lucie A; Lycklama À Nijeholt, Geert; Emmer, Bart J; van der Worp, H Bart; Nederkoorn, Paul J; Roos, Yvo B W E M; van Oostenbrugge, Robert J; van Zwam, Wim H; Majoie, Charles B L M; van der Lugt, Aad; Dippel, Diederik W J

    2017-07-01

    High blood pressure (BP) is associated with poor outcome and the occurrence of symptomatic intracranial hemorrhage in acute ischemic stroke. Whether BP influences the benefit or safety of intra-arterial treatment (IAT) is not known. We aimed to assess the relation of BP with functional outcome, occurrence of symptomatic intracranial hemorrhage and effect of IAT. This is a post hoc analysis of the MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands). BP was measured at baseline, before IAT or stroke unit admission. We estimated the association of baseline BP with the score on the modified Rankin Scale at 90 days and safety parameters with ordinal and logistic regression analysis. Effect of BP on the effect of IAT was tested with multiplicative interaction terms. Systolic BP (SBP) had the best correlation with functional outcome. This correlation was U-shaped; both low and high baseline SBP were associated with poor functional outcome. Higher SBP was associated with symptomatic intracranial hemorrhage (adjusted odds ratio, 1.25 for every 10 mm Hg higher SBP [95% confidence interval, 1.09-1.44]). Between SBP and IAT, there was no interaction for functional outcome, symptomatic intracranial hemorrhage, or other safety parameters; the absolute benefit of IAT was evident for the whole SBP range. The same was found for diastolic BP. BP does not affect the benefit or safety of IAT in patients with acute ischemic stroke caused by proximal intracranial vessel occlusion. Our data provide no arguments to withhold or delay IAT based on BP. URL: http://www.isrctn.com. Unique identifier: ISRCTN10888758. © 2017 American Heart Association, Inc.

  17. Blood Disorders

    Science.gov (United States)

    ... blood cells, white blood cells and platelets. Blood disorders affect one or more parts of the blood ... They can be acute or chronic. Many blood disorders are inherited. Other causes include other diseases, side ...

  18. Quality Assurance of Forensic-Toxicological Analysis: Selected Issues

    Directory of Open Access Journals (Sweden)

    Maciej J. Bogusz

    2015-05-01

    Full Text Available In the present paper, recent trends in the formulation and application of quality assurance (QA parameters in forensic toxicology, as well as the selected validated applications published in the last five years, are reviewed. In the first part, QA aspects of the analysis of toxicologically relevant compounds in various materials are presented. In particular, QA aspects of analysis of various matrices, like seized street drugs, formalin fixed tissues, dried blood spots, oral fluid, hair, and nails are reviewed. The second part is devoted to identification as applied in general, untargeted and targeted screening; regulations and recommendations issued on international and national levels are presented in the third part, whereas existing QA programs applicable for forensic analysis are discussed in the fourth part.

  19. Factors in enhancing blood safety by nucleic acid technology testing for human immunodeficiency virus, hepatitis C virus and hepatitis B virus

    Science.gov (United States)

    Shyamala, Venkatakrishna

    2014-01-01

    In the last few decades through an awareness of transfusion transmitted infections (TTI), a majority of countries have mandated serology based blood screening assays for Human immunodeficiency virus (HIV), Hepatitis C virus (HCV), and Hepatitis B virus (HBV). However, despite improved serology assays, the transfusion transmission of HIV, HCV, and HBV continues, primarily due to release of serology negative units that are infectious because of the window period (WP) and occult HBV infections (OBI). Effective mode of nucleic acid technology (NAT) testing of the viruses can be used to minimize the risk of TTIs. This review compiles the examples of NAT testing failures for all three viruses; analyzes the causes for failure, and the suggestions from retrospective studies to minimize such failures. The results suggest the safest path to be individual donation testing (ID) format for highest sensitivity, and detection of multiple regions for rapidly mutating and recombining viruses. The role of blood screening in the context of the donation and transfusion practices in India, the donor population, and the epidemiology is also discussed. World wide, as the public awareness of TTIs increases, as the recipient rights for safe blood are legally upheld, as the possibility to manage diseases such as hepatitis through expensive and prolonged treatment becomes accessible, and the societal responsibility to shoulder the health costs as in the case for HIV becomes routine, there is much to gain by preventing infections than treating diseases. PMID:24678167

  20. Factors in enhancing blood safety by nucleic acid technology testing for human immunodeficiency virus, hepatitis C virus and hepatitis B virus

    Directory of Open Access Journals (Sweden)

    Venkatakrishna Shyamala

    2014-01-01

    Full Text Available In the last few decades through an awareness of transfusion transmitted infections (TTI, a majority of countries have mandated serology based blood screening assays for Human immunodeficiency virus (HIV, Hepatitis C virus (HCV, and Hepatitis B virus (HBV. However, despite improved serology assays, the transfusion transmission of HIV, HCV, and HBV continues, primarily due to release of serology negative units that are infectious because of the window period (WP and occult HBV infections (OBI. Effective mode of nucleic acid technology (NAT testing of the viruses can be used to minimize the risk of TTIs. This review compiles the examples of NAT testing failures for all three viruses; analyzes the causes for failure, and the suggestions from retrospective studies to minimize such failures. The results suggest the safest path to be individual donation testing (ID format for highest sensitivity, and detection of multiple regions for rapidly mutating and recombining viruses. The role of blood screening in the context of the donation and transfusion practices in India, the donor population, and the epidemiology is also discussed. World wide, as the public awareness of TTIs increases, as the recipient rights for safe blood are legally upheld, as the possibility to manage diseases such as hepatitis through expensive and prolonged treatment becomes accessible, and the societal responsibility to shoulder the health costs as in the case for HIV becomes routine, there is much to gain by preventing infections than treating diseases.

  1. Pre-donation screening of blood for transfusion transmissible infections: the gains and the pains - experience at a resource limited blood bank.

    Science.gov (United States)

    Shittu, A O; Olawumi, H O; Adewuyi, J O

    2014-09-01

    To determine whether or not pre-donation testing of blood donors affords substantial cost savings without compromise to blood transfusion safety. Pre-donation testing of blood donors for Transfusion Transmissible Infections (TTIs) is done in most developing countries because substantial cost savings are made from resources, materials and man-hours which would have been spent to procure infected blood units. Simple rapid test kits used in pre-donation testing is not as sensitive as the Enzyme Linked Immuno-sorbent Assay (ELISA) method used in post-donation screening in a quality assured manner. It is a retrospective study where records of pre- and post-donation tests done in donor clinic of University of Ilorin Teaching Hospital, between January and December 2010 were retrieved. All processes and inputs were evaluated and costs calculated for pre-donation testing by simple rapid techniques and post donation screening by ELISA. 5000 prospective donors were tested in the study period. The cost of single rapid Pre-donation testing was less than that of single ELISA Post-donation screen. The cost of double rapid Pre-donation and Post donation ELISA screen exceeded the cost of single post donation ELISA screen. Substantial cost savings were made when single rapid Pre-donation testing is relied on. More blood units were found reactive for the TTIs with the more expensive Post-donation ELISA. Pre-donation testing of blood donors was not cost effective. Although, there is an apparent savings if pre-donation testing is not followed by post-donation ELISA testing, it is done at a compromise to blood transfusion safety.

  2. Oil and gas pipelines with hydrophobic surfaces better equipped to deal with gas hydrate flow assurance issues

    DEFF Research Database (Denmark)

    Perfeldt, Christine Malmos; Sharifi, Hassan; von Solms, Nicolas

    2015-01-01

    Gas hydrate deposition can cause plugging in oil and gas pipelines with resultant flow assurance challenges. Presently, the energy industry uses chemical additives in order to manage hydrate formation, however these chemicals are expensive and may be associated with safety and environmental...

  3. The role of food quality assurance and product certification systems on marketing aspects

    Science.gov (United States)

    Petrović, Z.; Milićević, D.; Nastasijević, I.; Đorđević, V.; Trbović, D.; Velebit, B.

    2017-09-01

    The level of quality that a product offers to consumers is a fundamental aspect of competition in many markets. Consumers’ confidence in the safety and quality of foods they buy and consume is a significant support to the economic development of production organizations of this type, and therefore the overall economic development. Consumer concerns about food safety as well as the globalization of food production have also led to the existence of a global internationally linked food production and distribution system. The necessity demanded by the consumer population to provide safe food with consistent quality at an attractive price imposes a choice of an appropriate quality assurance model in accordance with the specific properties of the product and the production processes. Modern trends, especially for the last ten years in quality assurance within specific production, such as the food industry, have marked the trend of hyperproduction and a number of production and safety standards, as well as a change of approach in the certification process of organizations according to one or more standards. This can be an additional source of costs for organizations, and can burden the food business operator`s budget in order to ensure their consistent application and maintenance. Quality assurance (QA) standards are considered to be a proven mechanism for delivering quality of product.

  4. 7 CFR 15a.4 - Assurance required.

    Science.gov (United States)

    2010-01-01

    ... Federal share of the fair market value of the property is not upon such sale or transfer properly... financial assistance extended to provide real property or structures thereon, such assurance shall obligate... the real property or structures are used to provide an education program or activity. (2) In the case...

  5. From quality assurance to total quality management

    OpenAIRE

    Andreea Ionică

    2003-01-01

    Quality assurance is broadly the prevention of quality problems through planned and systematic activities. These will include the establishment of a good quality management system and the assessment of its adequacy, the audit of the operation of the system, and the review of the system itself

  6. Supervision and Quality Assurance Strategies in Education ...

    African Journals Online (AJOL)

    This paper examines the need for quality assurance and quality control strategies in improving the effectiveness of educational provision and teacher performance in schools. Governments all over the word in an attempt to educate and develop their citizens spend huge amount of money on teachers and schools but in most ...

  7. Understanding Outstanding: quality assurance in colonoscopy

    NARCIS (Netherlands)

    V. de Jonge (Vincent); J.S. Nicolaas (Jerome Sint)

    2012-01-01

    textabstractSince a couple of years, quality assurance (QA) stands at the core of the attention in the healthcare sector. Especially after the publication in 2000 of the Institute of Medicine’s report ‘To err is human’ the interest in QA has taken a quantum leap and many quality initiatives

  8. Transuranic Waste Characterization Quality Assurance Program Plan

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-04-30

    This quality assurance plan identifies the data necessary, and techniques designed to attain the required quality, to meet the specific data quality objectives associated with the DOE Waste Isolation Pilot Plant (WIPP). This report specifies sampling, waste testing, and analytical methods for transuranic wastes.

  9. Ensuring Quality Assurance in Vocational Education

    Science.gov (United States)

    Idialu, Ethel E.

    2013-01-01

    Vocational education emphasises skill acquisition. Quality assurance in vocational education is a concept that is concerned with high performance involving activities with vocational education such as teaching, learning, infrastructures, students' behaviour and the entire academic process. Quality vocational education refers to input and output of…

  10. Quality assurance in undergraduate medical education: standards ...

    African Journals Online (AJOL)

    Quality assurance in undergraduate medical education: standards for accreditation. ... South African Journal of Higher Education ... was investigated, and a set of national standards was developed for use in self-evaluations of medical schools and in the accreditation of medical education programmes in South Africa.

  11. APPROACH TO QUALITY ASSURANCE IN HIGHER EDUCATION

    Directory of Open Access Journals (Sweden)

    Zora Arsovski

    2007-03-01

    Full Text Available Quality assurance in higher education is streamed in two interconnected concepts: (1 quality management according to ISO 9000 and (2 Bologna process. In this paper both concepts are presented, with point on internal state and term plan activities for quality improvement in higher education in Serbia.

  12. Assuring Quality in Online Course Delivery

    Science.gov (United States)

    Matuga, Julia M.; Wooldridge, Deborah G.; Poirier, Sandra

    This paper examines the critical issue of assuring quality online course delivery by examining four key components of online teaching and learning. The topic of course delivery is viewed as a cultural issue that permeates processes from the design of an online course to its evaluation. First, the authors examine and review key components of and…

  13. On the development of quality assurance

    DEFF Research Database (Denmark)

    Andersen, Jens

    2014-01-01

    Contemporary research in quality assurance indicates that large uncertainties observed in interlaboratory comparisons to a large extent originate from a lack of competence of laboratory staff. This explanation is challenged by the present article for which six technologies and multiple series of ...

  14. 24 CFR 3.115 - Assurance required.

    Science.gov (United States)

    2010-04-01

    ... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Assurance required. 3.115 Section 3.115 Housing and Urban Development Office of the Secretary, Department of Housing and Urban Development NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE...

  15. Quality Assurance in Distance and Open Learning

    Science.gov (United States)

    Mahafzah, Mohammed Hasan

    2012-01-01

    E-learning has become an increasingly important teaching and learning mode in educational institutions and corporate training. The evaluation of E-learning, however, is essential for the quality assurance of E-learning courses. This paper constructs a three-phase evaluation model for E-learning courses, which includes development, process, and…

  16. Quality Assurance of Ultrasonic Diagnosis in Breast

    Energy Technology Data Exchange (ETDEWEB)

    Chung, Soo Young; Kim, Hong Dae [Hallym University, Kangnam Sacred Heart Hospital, Seoul (Korea, Republic of)

    2006-06-15

    Sonography is a subjective diagnostic method which is highly dependent on the experience of the operator and the equipment quality which requires real-time adjustments. Breast screening examination currently consists of clinical examination and mammography. Breast sonography, either supplementary to mammography or independently, is indicated for the dense breast, especially in younger women. Breast sonography is especially applicable for Korean women because of the denser breast parenchyma and the approximately 10-year younger incidence rate of breast cancer of Korean women compared to western women. To avoid unnecessary breast biopsy because of the high rate of false positive lesions in breast parenchyma, which is different from other body organs such as the liver or the kidney, a quality assurance program for breast sonography is essential. The quality assurance of breast ultrasound involves quality assurance of the equipment, imaging display and acquisition of clinical images, personnel qualifications and other aspects such as unification of lexicon, guideline of diagnostic examination and reporting system; US BI-RAD reporting system, assessment items and organization, education program, medical audit, certification issues, and medicolegal issues. A breast sonographic quality assurance system should be established before a scheme to initiate governmental medical insurance for breast sonography

  17. Quality Assurance in University Guidance Services

    Science.gov (United States)

    Simon, Alexandra

    2014-01-01

    In Europe there is no common quality assurance framework for the delivery of guidance in higher education. Using a case study approach in four university career guidance services in England, France and Spain, this article aims to study how quality is implemented in university career guidance services in terms of strategy, standards and models,…

  18. 14 CFR 152.405 - Assurances.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Assurances. 152.405 Section 152.405 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRPORTS..., subpart E, to ensure that no person shall, on the grounds of race, creed, color, national origin, or sex...

  19. Quality assurance in materials and construction

    Science.gov (United States)

    2007-06-01

    This review is a product of the FHWA 2006, National Review Program (NRP). Quality Assurance (QA) was selected for review in 2006 because the program was ranked as one of the top five areas of interest for review by FHWA. Over the last 10 years an ave...

  20. CyberCIEGE: Gaming for Information Assurance

    OpenAIRE

    Irvine, Cynthia E.; Thompson, Michael F.; Allen, Ken

    2004-01-01

    Cyber security students need to understand both the impact that poor security choices can have on an organization's health and the connect steps that can improve security within it. In short, they must understand information assurance (IA) principles and how to apply them.

  1. Assurance on sustainability reporting: An auditor's view

    NARCIS (Netherlands)

    Wallage, Philip

    2000-01-01

    This article discusses initial experiences with a new assurance service: the verification of sustainability reports providing assertions regarding financial, environmental, and social issues. For illustration purposes, references to the verification ofThe Shell Report 2000 are made. Because of the

  2. Risk-Significant Adverse Condition Awareness Strengthens Assurance of Fault Management Systems

    Science.gov (United States)

    Fitz, Rhonda

    2017-01-01

    As spaceflight systems increase in complexity, Fault Management (FM) systems are ranked high in risk-based assessment of software criticality, emphasizing the importance of establishing highly competent domain expertise to provide assurance. Adverse conditions (ACs) and specific vulnerabilities encountered by safety- and mission-critical software systems have been identified through efforts to reduce the risk posture of software-intensive NASA missions. Acknowledgement of potential off-nominal conditions and analysis to determine software system resiliency are important aspects of hazard analysis and FM. A key component of assuring FM is an assessment of how well software addresses susceptibility to failure through consideration of ACs. Focus on significant risk predicted through experienced analysis conducted at the NASA Independent Verification Validation (IVV) Program enables the scoping of effective assurance strategies with regard to overall asset protection of complex spaceflight as well as ground systems. Research efforts sponsored by NASA's Office of Safety and Mission Assurance defined terminology, categorized data fields, and designed a baseline repository that centralizes and compiles a comprehensive listing of ACs and correlated data relevant across many NASA missions. This prototype tool helps projects improve analysis by tracking ACs and allowing queries based on project, mission type, domaincomponent, causal fault, and other key characteristics. Vulnerability in off-nominal situations, architectural design weaknesses, and unexpected or undesirable system behaviors in reaction to faults are curtailed with the awareness of ACs and risk-significant scenarios modeled for analysts through this database. Integration within the Enterprise Architecture at NASA IVV enables interfacing with other tools and datasets, technical support, and accessibility across the Agency. This paper discusses the development of an improved workflow process utilizing this

  3. Phase Ia clinical evaluation of the safety and immunogenicity of the Plasmodium falciparum blood-stage antigen AMA1 in ChAd63 and MVA vaccine vectors.

    Directory of Open Access Journals (Sweden)

    Susanne H Sheehy

    Full Text Available Traditionally, vaccine development against the blood-stage of Plasmodium falciparum infection has focused on recombinant protein-adjuvant formulations in order to induce high-titer growth-inhibitory antibody responses. However, to date no such vaccine encoding a blood-stage antigen(s alone has induced significant protective efficacy against erythrocytic-stage infection in a pre-specified primary endpoint of a Phase IIa/b clinical trial designed to assess vaccine efficacy. Cell-mediated responses, acting in conjunction with functional antibodies, may be necessary for immunity against blood-stage P. falciparum. The development of a vaccine that could induce both cell-mediated and humoral immune responses would enable important proof-of-concept efficacy studies to be undertaken to address this question.We conducted a Phase Ia, non-randomized clinical trial in 16 healthy, malaria-naïve adults of the chimpanzee adenovirus 63 (ChAd63 and modified vaccinia virus Ankara (MVA replication-deficient viral vectored vaccines encoding two alleles (3D7 and FVO of the P. falciparum blood-stage malaria antigen; apical membrane antigen 1 (AMA1. ChAd63-MVA AMA1 administered in a heterologous prime-boost regime was shown to be safe and immunogenic, inducing high-level T cell responses to both alleles 3D7 (median 2036 SFU/million PBMC and FVO (median 1539 SFU/million PBMC, with a mixed CD4(+/CD8(+ phenotype, as well as substantial AMA1-specific serum IgG responses (medians of 49 µg/mL and 41 µg/mL for 3D7 and FVO AMA1 respectively that demonstrated growth inhibitory activity in vitro.ChAd63-MVA is a safe and highly immunogenic delivery platform for both alleles of the AMA1 antigen in humans which warrants further efficacy testing. ChAd63-MVA is a promising heterologous prime-boost vaccine strategy that could be applied to numerous other diseases where strong cellular and humoral immune responses are required for protection.ClinicalTrials.gov NCT01095055.

  4. Transfusion requirements in septic shock (TRISS) trial - comparing the effects and safety of liberal versus restrictive red blood cell transfusion in septic shock patients in the ICU

    DEFF Research Database (Denmark)

    Holst, Lars B; Haase, Nicolai; Wetterslev, Jørn

    2013-01-01

    BACKGROUND: Transfusion of red blood cells (RBC) is recommended in septic shock and the majority of these patients receive RBC transfusion in the intensive care unit (ICU). However, benefit and harm of RBCs have not been established in this group of high-risk patients. METHODS: The Transfusion...... Requirements in Septic Shock (TRISS) trial is a multicenter trial with assessor-blinded outcome assessment, randomising 1,000 patients with septic shock in 30 Scandinavian ICUs to receive transfusion with pre-storage leuko-depleted RBC suspended in saline-adenine-glucose and mannitol (SAGM) at haemoglobin...

  5. A Socio-technical Analysis of Information Systems Security Assurance : A Case Study for Effective Assurance

    OpenAIRE

    Chaula, Job Asheri

    2006-01-01

    This thesis examines the concepts of Information System (IS) security assurance using a socio-technical framework. IS security assurance deals with the problem of estimating how well a particular security system will function efficiently and effectively in a specific operational environment. In such environments, the IS interact with other systems such as ethical, legal, operational and administrative. Security failure in any of these systems may result in security failure of the whole system...

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

    Science.gov (United States)

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

    2016-11-01

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

  7. Accountants' Awareness And Perceptions About Assurance On XBRL Financial Statements

    National Research Council Canada - National Science Library

    Roopa Venkatesh; Jack Armitage

    2012-01-01

      The purpose of this study is to gather information about accountants' and auditors' level of knowledge of XBRL and their perceptions about the importance of providing assurance and the level of assurance needed...

  8. Process-Based Mission Assurance- Knowledge Management System

    Science.gov (United States)

    Kantzes, Zachary S.; Wander, Stephen; Otero, Suzanne; Vantine, William; Stuart, Richard

    2005-12-01

    The Process-Based Mission Assurance - Knowledge Management System (PBMA-KMS) implemented at the National Aeronautics and Space Administration (NASA) focuses on the practical application of the knowledge management (KM) theory and is based on a systems engineering management approach coupled to a continual improvement and risk management philosophy. Not to be confused with an Agency mandate, an intense focus has been placed on grassroots input to the future of the product. By providing emphasis to both Agency safety and mission success objectives and individual users' needs, the PBMA-KMS team has been able to be both reactive to Agency requirements and proactive to the needs of the community.PBMA-KMS is an excellent case study on how to use new approaches to facilitate and integrate safety into the culture of an organization. Principle discussion topics include: • Overarching themes,• Tactical approaches,• Highlights of key functionalities, and• Agency KM approach of managed Darwinism.PBMA-KMS can show how, by providing top-level guidance along with the necessary tools and support, the organization not only receives immediate value, but the long-ranging benefits of a more experienced, effective, and engaged workforce.

  9. Assurance management program for the 30 Nova laser fusion project

    Energy Technology Data Exchange (ETDEWEB)

    Levy, A.J.

    1983-11-30

    The Nova assurance management program was developed using the quality assurance (QA) approach first implemented at LLNL in early 1978. The LLNL QA program is described as an introduction to the Nova assurance management program. The Nova system is described pictorially through the Nova configuration, subsystems and major components, interjecting the QA techniques which are being pragmatically used to assure the successful completion of the project.

  10. Right patient, Right blood

    DEFF Research Database (Denmark)

    Selberg, Hanne; Madsen, Trine Stougaard

    2014-01-01

    Right patient, Right Blood Simulation based training in blood transfusion practice in nursing education Background: In spite of strict checking procedures to handling transfusion of blood severe adverse reactions are likely to happen and the major cause of morbidity occurs to be liable to human...... errors. Nursing students have limited possibility to practice safe blood transfusion during clinical placements. We introduced simulation-based workshops to reinforce safe transfusion practice and thus increase patient safety but equally important to bridge the gap between theory and practice. Objectives......: The objective of the current study was to test workshops focusing on procedures of safe blood transfusion by combining theory and practice, integrating current guidelines on safe blood transfusion and hereby help students to better recognize and handle errors and adverse reactions. Methods: 372 third year...

  11. Study Abroad Programs: Making Safety a Priority

    Science.gov (United States)

    Buddan, Michael Craig; Budden, Connie B.; Juban, Rusty; Baraya, Aristides

    2014-01-01

    Increasingly, students are participating in study abroad programs. Such programs provide participants a variety of learning experiences. Developing cross-cultural appreciation, communication skills, maturity and a less ethno-centric mindset are among the impacts study abroad programs offer. However, care must be taken to assure student safety and…

  12. GLYCOHEMOGLOBIN - COMPARISON OF 12 ANALYTICAL METHODS, APPLIED TO LYOPHILIZED HEMOLYSATES BY 101 LABORATORIES IN AN EXTERNAL QUALITY ASSURANCE PROGRAM

    NARCIS (Netherlands)

    WEYKAMP, CW; PENDERS, TJ; MUSKIET, FAJ; VANDERSLIK, W

    Stable lyophilized ethylenediaminetetra-acetic acid (EDTA)-blood haemolysates were applied in an external quality assurance programme (SKZL, The Netherlands) for glycohaemoglobin assays in 101 laboratories using 12 methods. The mean intralaboratory day-to-day coefficient of variation (CV),

  13. Operational excellence (six sigma) philosophy: Application to software quality assurance

    Energy Technology Data Exchange (ETDEWEB)

    Lackner, M.

    1997-11-01

    This report contains viewgraphs on operational excellence philosophy of six sigma applied to software quality assurance. This report outlines the following: goal of six sigma; six sigma tools; manufacturing vs administrative processes; Software quality assurance document inspections; map software quality assurance requirements document; failure mode effects analysis for requirements document; measuring the right response variables; and questions.

  14. Quality Assurance in Postgraduate Education. ENQA Workshop Report 12

    Science.gov (United States)

    Bitusikova, Alexandra; Bohrer, Janet; Borosic, Ivana; Costes, Nathalie; Edinsel, Kerim; Hollander, Karoline; Jacobsson, Gunilla; Jakopovic, Ivan Filip; Kearney, Mary-Louise; Mulder, Fred; Negyesi, Judith; Pietzonka, Manuel

    2010-01-01

    The present report follows an ENQA (European Association for Quality Assurance in Higher Education) Workshop on Quality Assurance and Postgraduate Education, hosted by the Romanian Agency for Quality Assurance in Higher Education (ARACIS) in Brasov, Romania on 12-13 March 2009. The workshop was an excellent opportunity for ENQA members to exchange…

  15. Quality Assurance of Assessment and Moderation Discourses Involving Sessional Staff

    Science.gov (United States)

    Grainger, Peter; Adie, Lenore; Weir, Katie

    2016-01-01

    Quality assurance is a major agenda in tertiary education. The casualisation of academic work, especially in teaching, is also a quality assurance issue. Casual or sessional staff members teach and assess more than 50% of all university courses in Australia, and yet the research in relation to the role sessional staff play in quality assurance of…

  16. Managerialism and the Risky Business of Quality Assurance in Universities

    Science.gov (United States)

    Davis, Annemarie

    2017-01-01

    Purpose: This paper aims to identify what is needed to enhance academic quality assurance in a university, with specific efforts to reduce the risks associated with ritualised quality assurance practices. Design/methodology/approach: The aspects to enhance academic quality assurance efforts in managerial universities are identified through a…

  17. 75 FR 9142 - Information Assurance Scholarship Program (IASP)

    Science.gov (United States)

    2010-03-01

    ... of the Secretary 32 CFR Part 240 RIN 0790-AI28 Information Assurance Scholarship Program (IASP... executing an information assurance scholarship and grant program, known as the DoD Information Assurance Scholarship Program (IASP). DATES: Comments must be received by April 30, 2010. ADDRESSES: You may submit...

  18. 75 FR 63893 - Safety Advisory 2010-03

    Science.gov (United States)

    2010-10-18

    ... communications and technology and information `overload,' '' railroad employees need to maintain complete... INFORMATION CONTACT: Ronald Hynes, Director, Office of Safety Compliance and Assurance, Office of Railroad..., telephone (202) 493-6052. SUPPLEMENTARY INFORMATION: The overall safety of railroad operations has improved...

  19. Donating Blood

    Science.gov (United States)

    ... Teens For Kids For Parents MORE ON THIS TOPIC Is It Possible to Donate Blood After Having Hepatitis B? Hepatitis Natural Disasters: How to Help Blood Blood Transfusions Blood Types Contact Us Print Resources Send to ...

  20. Blood Basics

    Science.gov (United States)

    ... Patient Group Links Advocacy Toolkit Home For Patients Blood Basics Blood is a specialized body fluid. It ... about nine pints. Jump To: The Components of Blood and Their Importance Many people have undergone blood ...

  1. Blood culture

    Science.gov (United States)

    Culture - blood ... A blood sample is needed . The site where blood will be drawn is first cleaned with an antiseptic such ... organism from the skin getting into (contaminating) the blood sample and causing a false-positive result (see ...

  2. Constancy tests and quality assurance of the activimeters used in a radiopharmaceutical production unit

    Energy Technology Data Exchange (ETDEWEB)

    Gontijo, Rodrigo M.G.; Mamede, Marcelo [Centro de Desenvolvimento da Tecnologia Nuclear (CDTN/CNEN-MG), Belo Horizonte, MG (Brazil); Ferreira, Andréa V.; Nascimento, Leonardo T.C.; Costa, Flávia M.; Silva, Juliana B., E-mail: rodrigo.gontijo@cdtn.br, E-mail: mamede.mm@gmail.com [Universidade Federal de Minas Gerais (IMA/FM/UFMG), Belo Horizonte, MG (Brazil). Departamento de Anatomia e Imagem

    2017-07-01

    Activimeters (or dose calibrators) are essential instruments to verify activity of radiopharmaceutical after production and also before the dose administration in humans or animals for molecular imaging. The efficiency and safety measurements depend on, beside other factors, constancy tests and quality assurance. Thereby, the aim of this work was to perform constancy tests and quality assurance in the activimeters of the UPPR/CDTN, based on the CNEN-NN 3.05 Brazilian standard and the manufacturer's manual. Physical inspection, auto zero, background check, camera voltage, data check and constancy test were done. In addition, accuracy and precision tests were performed using a set of standard certified radioactive sources ({sup 57}Co, {sup 133}Ba and {sup 137}Cs), according to the CNEN NN 3.05 Brazilian standard. Linearity test was also performed to evaluate the response of the equipment in over the entire range of activities used in routine. The equipment are periodically submitted to the quality control tests and the results were compared. After performing the proposed tests it is possible to conclude that activimeters are in accordance with the requirements of the CNEN standard and manufacturer's manual. A quality control checklist was prepared to guide users and to record the results of quality assurance testing to monitor the equipment performance. This initiative is part of the quality assurance program implemented at UPPR. (author)

  3. [Quality assurance in occupational health services].

    Science.gov (United States)

    Michalak, J

    1996-01-01

    The general conditions influencing the quality assurance and audit in Polish occupational health services are presented. The factors promoting or hampering the implementation of quality assurance and audits are also discussed. The major influence on the transformation of Polish occupational health services in exorted by employers who are committed to cover the costs of the obligatory prophylactic examination of their employees. This is the factor which also contributes to the improvement of quality if services. The definitions of the most important terms are reviewed to highlight their accordance with the needs of occupational health services in Poland. The examples of audit are presented and the elements of selected methods of auditing are suggested to be adopted in Poland.

  4. Radiation Hardness Assurance for Space Systems

    Science.gov (United States)

    Poivey, Christian; Day, John H. (Technical Monitor)

    2002-01-01

    The space radiation environment can lead to extremely harsh operating conditions for on-board electronic box and systems. The characteristics of the radiation environment are highly dependent on the type of mission (date, duration and orbit). Radiation accelerates the aging of the electronic parts and material and can lead to a degradation of electrical performance; it can also create transient phenomena on parts. Such damage at the part level can induce damage or functional failure at electronic box, subsystem, and system levels. A rigorous methodology is needed to ensure that the radiation environment does not compromise the functionality and performance of the electronics during the system life. This methodology is called hardness assurance. It consists of those activities undertaken to ensure that the electronic piece parts placed in the space system perform to their design specifications after exposure to the space environment. It deals with system requirements, environmental definitions, part selection, part testing, shielding and radiation tolerant design. All these elements should play together in order to produce a system tolerant to.the radiation environment. An overview of the different steps of a space system hardness assurance program is given in section 2. In order to define the mission radiation specifications and compare these requirements to radiation test data, a detailed knowledge of the space environment and the corresponding electronic device failure mechanisms is required. The presentation by J. Mazur deals with the Earth space radiation environment as well as the internal environment of a spacecraft. The presentation by J. Schwank deals with ionization effects, and the presentation by T. Weatherford deals with Single particle Event Phenomena (SEP) in semiconductor devices and microcircuits. These three presentations provide more detailed background to complement the sections 3 and 4. Part selection and categorization are discussed in section

  5. The quality assurance program at K & S

    Energy Technology Data Exchange (ETDEWEB)

    Slowey, T.W. [AAPM Accredited Dosimetry Calibration Laboratory, Nashville, TN (United States)

    1993-12-31

    K & S operates the largest and one of the most comprehensive Accredited Dosimetry Calibration Laboratories (ADCLs) in the American Association of Physicists in Medicine (AAPM) secondary laboratory system. It offers calibrations covering energies from Grenz-Ray (0.03-mm Al) to cesium-137 and cobalt-60, brachytherapy source and well chamber calibrations for low-activity sources, and, recently, high-dose-rate iridium-192. The present Quality Assurance (QA) program at K & S began with the AAPM Guidelines for Accreditation (Task Group No. 22 and No. 3, 1989) and grew over the past 10 years to include all aspects of providing a private, self-supporting calibration service from a free-standing independent facility. Some aspects of the QA program were prompted by the requirements of the nuclear power industry while other parts were from national consensus standards or the experiences of staff. Redundancy and teamwork are the most important characteristics of this QA program. K & S has participated in a National Institute of Standards and Technology (NIST) measurement quality assurance (MQA) program since 1982, and, in recent years, an ADCL intralaboratory intercomparison was conducted by Task Group 3 of the Radiation Therapy Committee of the AAPM. One measure of the credibility of a QA program is consistent performance on the MQA program and the ADCL intercomparisons over the past 10 years. An equally important measure of the ability of a program to assure quality results is the frequency of reported errors.

  6. Blood and Diversity

    Science.gov (United States)

    ... BLOOD Learn About Blood Blood Facts and Statistics Blood Components Whole Blood and Red Blood Cells Platelets Plasma ... About Blood Blood Facts and Statistics Blood Types Blood Components What Happens to Donated Blood Blood and Diversity ...

  7. Girlfriends' Health and Safety Tips

    Science.gov (United States)

    ... Professionals Girlfriends’ Health Heart Disease Prevention Mother’s Day Weddings Multimedia Badges and Buttons Podcasts National Women’s Health ... Vaccinations Violence Prevention What Should You Know About Blood Disorders in Women? Women's Safety and Health Issues ...

  8. Drug Safety

    Science.gov (United States)

    ... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...

  9. Effect of consuming a purple-fleshed sweet potato beverage on health-related biomarkers and safety parameters in Caucasian subjects with elevated levels of blood pressure and liver function biomarkers: a 4-week, open-label, non-comparative trial.

    Science.gov (United States)

    Oki, Tomoyuki; Kano, Mitsuyoshi; Watanabe, Osamu; Goto, Kazuhisa; Boelsma, Esther; Ishikawa, Fumiyasu; Suda, Ikuo

    2016-01-01

    An open-label study with one treatment arm was conducted to investigate changes in health-related biomarkers (blood pressure and liver enzyme activity) and the safety of 4 weeks of consuming a purple-fleshed sweet potato beverage in Caucasian subjects. Twenty healthy adults, 18-70 years of age, with a body mass index >25 kg/m(2), elevated blood pressure and elevated levels of liver function biomarkers consumed two cartons of purple-fleshed sweet potato beverage (125 ml, including 117 mg anthocyanin per carton) daily for 4 weeks. Hematology, serum clinical profile, dipstick urinalysis and blood pressure were determined before consumption, at 2 and 4 weeks of consumption and after a 2-week washout period. A trend was found toward lowering systolic blood pressure during the treatment period (p=0.0590). No significant changes were found in diastolic blood pressure throughout the study period. Systolic blood pressure was significantly lower after 4 weeks of consumption compared with before consumption (p=0.0125) and was significantly higher after the 2-week washout period compared with after consumption (p=0.0496). The serum alanine aminotransferase level significantly increased over time, but aspartate aminotransferase and γ-glutamyltransferase levels stayed within the normal range of reference values. Safety parameters of the blood and urine showed no clinically relevant changes. The consumption of a purple-fleshed sweet potato beverage for 4 weeks resulted in no clinically relevant changes in safety parameters of the blood and urine and showed a trend toward lowering systolic blood pressure.

  10. Reducing blood volume requirements for clinical pathology testing in toxicologic studies-points to consider.

    Science.gov (United States)

    Poitout-Belissent, Florence; Aulbach, Adam; Tripathi, Niraj; Ramaiah, Lila

    2016-12-01

    In preclinical safety assessment, blood volume requirements for various endpoints pose a major challenge. The goal of this working group was to review current practices for clinical pathology (CP) testing in preclinical toxicologic studies, and to discuss advantages and disadvantages of methods for reducing blood volume requirements. An industry-wide survey was conducted to gather information on CP instrumentation and blood collection practices for hematology, clinical biochemistry, and coagulation evaluation in laboratory animals involved in preclinical studies. Based on the survey results and collective experience of the authors, the working group proposes the following "points to consider" for CP testing: (1) For most commercial analyzers, 0.5 mL and 0.8 mL of whole blood are sufficient for hematology and biochemistry evaluation, respectively. (2) Small analyzers with low volume requirements and low throughput have limited utility in preclinical studies. (3) Sample pooling or dilution is inappropriate for many CP methods. (4) Appropriate collection sites should be determined based on blood volume requirements and technical expertise. (5) Microsampling does not provide sufficient volume given current analyzer and quality assurance requirements. (6) Study design considerations include: the use of older/larger animals (rodents), collection of CP samples before toxicokinetic samples, use of separate subsets of mice for hematology and clinical biochemistry testing, use of a priority list for clinical biochemistry, and when possible, eliminating coagulation testing. © 2016 American Society for Veterinary Clinical Pathology.

  11. Soyuz-TM-based interim Assured Crew Return Vehicle (ACRV) for the Space Station Freedom

    Science.gov (United States)

    Semenov, Yu. P.; Babkov, Oleg I.; Timchenko, Vladimir A.; Craig, Jerry W.

    1993-01-01

    The concept of using the available Soyuz-TM Assured Crew Return Vehicle (ACRV) spacecraft for the assurance of the safety of the Space Station Freedom (SSF) crew after the departure of the Space Shuttle from SSF was proposed by the NPO Energia and was accepted by NASA in 1992. The ACRV will provide the crew with the capability to evacuate a seriously injured/ill crewmember from the SSF to a ground-based care facility under medically tolerable conditions and with the capability for a safe evacuation from SSF in the events SSF becomes uninhabitable or the Space Shuttle flights are interrupted for a time that exceeds SSF ability for crew support and/or safe operations. This paper presents the main results of studies on Phase A (including studies on the service life of ACRV; spacecraft design and operations; prelaunch processing; mission support; safety, reliability, maintenance and quality and assurance; landing, and search/rescue operations; interfaces with the SSF and with Space Shuttle; crew accommodation; motion of orbital an service modules; and ACRV injection by the Expendable Launch Vehicles), along with the objectives of further work on the Phase B.

  12. Lessons learned from development and quality assurance of software systems at the Halden Project

    Energy Technology Data Exchange (ETDEWEB)

    Bjorlo, T.J.; Berg, O.; Pehrsen, M.; Dahll, G.; Sivertsen, T. [OECD Halden Reactor Project (Norway)

    1996-03-01

    The OECD Halden Reactor Project has developed a number of software systems within the research programmes. These programmes have comprised a wide range of topics, like studies of software for safety-critical applications, development of different operator support systems, and software systems for building and implementing graphical user interfaces. The systems have ranged from simple prototypes to installations in process plants. In the development of these software systems, Halden has gained much experience in quality assurance of different types of software. This paper summarises the accumulated experience at the Halden Project in quality assurance of software systems. The different software systems being developed at the Halden Project may be grouped into three categories. These are plant-specific software systems (one-of-a-kind deliveries), generic software products, and safety-critical software systems. This classification has been found convenient as the categories have different requirements to the quality assurance process. In addition, the experience from use of software development tools and proprietary software systems at Halden, is addressed. The paper also focuses on the experience gained from the complete software life cycle, starting with the software planning phase and ending with software operation and maintenance.

  13. Obtaining Valid Safety Data for Software Safety Measurement and Process Improvement

    Science.gov (United States)

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

    2010-01-01

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

  14. Survival after blood transfusion

    DEFF Research Database (Denmark)

    Kamper-Jørgensen, Mads; Ahlgren, Martin; Rostgaard, Klaus

    2008-01-01

    of transfusion recipients in Denmark and Sweden followed for up to 20 years after their first blood transfusion. Main outcome measure was all-cause mortality. RESULTS: A total of 1,118,261 transfusion recipients were identified, of whom 62.0 percent were aged 65 years or older at the time of their first...... the SMR remained significantly 1.3-fold increased. CONCLUSION: The survival and relative mortality patterns among blood transfusion recipients were characterized with unprecedented detail and precision. Our results are relevant to assessments of the consequences of possible transfusion-transmitted disease...... as well as for cost-benefit estimation of new blood safety interventions....

  15. 76 FR 58049 - Atomic Safety and Licensing Board; Honeywell International, Inc.; Metropolis Works Uranium...

    Science.gov (United States)

    2011-09-19

    ... COMMISSION Atomic Safety and Licensing Board; Honeywell International, Inc.; Metropolis Works Uranium... assurance for its Metropolis Works uranium conversion facility in Metropolis, Illinois. \\1\\ LBP-11-19, 74... Financial Assurance Requirements, Honeywell Metropolis Works, Material License No. SUB- 526 (TAC No. L32718...

  16. 77 FR 65000 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-10-24

    ... HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management Advisory Committee; Notice... be open to the public. Name of Committee: Drug Safety and Risk Management Advisory Committee. General... (REMS) with Elements to Assure Safe Use (ETASU) before CDER's Drug Safety and Risk Management Advisory...

  17. A Microbial Assessment Scheme to measure microbial performance of Food Safety Management Systems

    NARCIS (Netherlands)

    Jacxsens, L.; Kussaga, J.; Luning, P.A.; Spiegel, van der M.; Devlieghere, F.; Uyttendaele, M.

    2009-01-01

    A Food Safety Management System (FSMS) implemented in a food processing industry is based on Good Hygienic Practices (GHP), Hazard Analysis Critical Control Point (HACCP) principles and should address both food safety control and assurance activities in order to guarantee food safety. One of the

  18. Identification of Core Competencies for an Undergraduate Food Safety Curriculum Using a Modified Delphi Approach

    Science.gov (United States)

    Johnston, Lynette M.; Wiedmann, Martin; Orta-Ramirez, Alicia; Oliver, Haley F.; Nightingale, Kendra K.; Moore, Christina M.; Stevenson, Clinton D.; Jaykus, Lee-Ann

    2014-01-01

    Identification of core competencies for undergraduates in food safety is critical to assure courses and curricula are appropriate in maintaining a well-qualified food safety workforce. The purpose of this study was to identify and refine core competencies relevant to postsecondary food safety education using a modified Delphi method. Twenty-nine…

  19. Clinical efficacy and safety of primary antifungal prophylaxis with posaconazole versus fluconazole in allogeneic blood hematopoietic stem cell transplantation recipients-A retrospective analysis of a single medical center in Taiwan.

    Science.gov (United States)

    Wang, Ching-Hsun; Kan, Li-Ping; Lin, Hsin-An; Chang, Feng-Yee; Wang, Ning-Chi; Lin, Te-Yu; Chao, Tsu-Yi; Kao, Woei-Yau; Ho, Ching-Liang; Chen, Yeu-Chin; Dai, Ming-Shen; Chang, Ping-Ying; Wu, Yi-Ying; Lin, Jung-Chung

    2016-08-01

    The efficacy and safety of posaconazole compared to fluconazole as antifungal prophylaxis in patients receiving allogeneic blood hematopoietic stem cell transplantation (allo-HSCT) during the early neutropenic phase without graft-versus-host disease (GVHD) was uncertain. The medical records of allo-HSCT recipients from a single institution, who received oral fluconazole (from January 2005 to June 2011) or oral posaconazole (from June 2011 to December 2013) during the early neutropenic phase (until engraftment), were retrospectively reviewed. There were 52 allo-HSCT recipients, two of whom were younger than 18 years of age. Twelve cases received posaconazole and 40 cases received fluconazole as primary antifungal prophylaxis. The two groups had similar transplant characteristics, conditioning, and GVHD prophylaxis regimens. The fluconazole group had a higher risk for development of invasive fungal infections within 90 days after allo-HSCT (43% vs. 8.3%, p = 0.039). Kaplan-Meier analysis indicated that the cumulative incidence of invasive fungal infection for 90 days after allo-HSCT was higher in the fluconazole group (log rank test, p = 0.047). Early discontinuation of antifungal prophylaxis for intolerance was significantly lower in the posaconazole group (8.3% vs. 50%, p = 0.017). Both groups had similar rates of impaired liver function. Analysis of primary fungal prophylaxis during the early neutropenic phase following allo-HSCT indicated that posaconazole was more effective and was better tolerated than fluconazole. Both drugs had similar safety profiles. Copyright © 2014. Published by Elsevier B.V.

  20. Blood Clots

    Science.gov (United States)

    Symptoms Blood clots By Mayo Clinic Staff Blood clots are gel-like clumps of blood. They are beneficial when they form in response to an injury or a cut, plugging the injured blood vessel, which stops bleeding. Some blood clots form inside your veins without a good reason and don't ...

  1. Safety assessment for EPS electron-proton spectrometer

    Science.gov (United States)

    Gleeson, P.

    1971-01-01

    A safety analysis was conducted to identify the efforts required to assure relatively hazard free operation of the EPS and to meet the safety requirements of the program. Safety engineering criteria, principles, and techniques in applicable disciplines are stressed in the performance of the system and subsystem studies; in test planning; in the design, development, test, evaluation, and checkout of the equipment; and the operating procedures for the EPS program.

  2. Identification of Vehicle Health Assurance Related Trends

    Science.gov (United States)

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

    2014-01-01

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

  3. Measurement quality assurance for radioassay laboratories

    Energy Technology Data Exchange (ETDEWEB)

    McCurdy, D.E. [Yankee Atomic Environmental Laboratory, Boston, MA (United States)

    1993-12-31

    Until recently, the quality of U.S. radioassay laboratory services has been evaluated by a limited number of governmental measurement assurance programs (MAPs). The major programs have been limited to the U.S. Department of Energy (DOE), the U.S. Environmental Protection Agency (EPA) and the U.S. Nuclear Regulatory Commission (NRC). In 1988, an industry MAP was established for the nuclear power utility industry through the U.S. Council for Energy Awareness/National Institute of Standards and Technology (USCEA/NIST). This program functions as both a MAP for utility laboratories and/or their commercial contractor laboratories, and as a traceability program for the U.S. radioactive source manufacturers and the utility laboratories. Each of these generic MAPs has been initiated and is maintained to serve the specific needs of the sponsoring agency or organization. As a result, there is diversification in their approach, scope, requirements, and degree of traceability to NIST. In 1987, a writing committee was formed under the American National Standards Institute (ANSI) N42.2 committee to develop a standard to serve as the basis document for the creation of a national measurement quality assurance (MQA) program for radioassay laboratories in the U.S. The standard is entitled, {open_quotes}Measurement Quality Assurance For Radioassay Laboratories.{open_quotes} The document was developed to serve as a guide for MQA programs maintained for the specialized sectors of the radioassay community, such as bioassay, routine environmental monitoring, environmental restoration and waste management, radiopharmaceuticals, and nuclear facilities. It was the intent of the writing committee to develop a guidance document that could be utilized to establish a laboratory`s specific data quality objectives (DQOs) that govern the operational requirements of the radioassay process, including mandated protocols and recommendations.

  4. Health equity monitoring for healthcare quality assurance.

    Science.gov (United States)

    Cookson, R; Asaria, M; Ali, S; Shaw, R; Doran, T; Goldblatt, P

    2018-01-06

    Population-wide health equity monitoring remains isolated from mainstream healthcare quality assurance. As a result, healthcare organizations remain ill-informed about the health equity impacts of their decisions - despite becoming increasingly well-informed about quality of care for the average patient. We present a new and improved analytical approach to integrating health equity into mainstream healthcare quality assurance, illustrate how this approach has been applied in the English National Health Service, and discuss how it could be applied in other countries. We illustrate the approach using a key quality indicator that is widely used to assess how well healthcare is co-ordinated between primary, community and acute settings: emergency inpatient hospital admissions for ambulatory care sensitive chronic conditions ("potentially avoidable emergency admissions", for short). Whole-population data for 2015 on potentially avoidable emergency admissions in England were linked with neighborhood deprivation indices. Inequality within the populations served by 209 clinical commissioning groups (CCGs: care purchasing organizations with mean population 272,000) was compared against two benchmarks - national inequality and inequality within ten similar populations - using neighborhood-level models to simulate the gap in indirectly standardized admissions between most and least deprived neighborhoods. The modelled inequality gap for England was 927 potentially avoidable emergency admissions per 100,000 people, implying 263,894 excess hospitalizations associated with inequality. Against this national benchmark, 17% of CCGs had significantly worse-than-benchmark equity, and 23% significantly better. The corresponding figures were 11% and 12% respectively against the similar populations benchmark. Deprivation-related inequality in potentially avoidable emergency admissions varies substantially between English CCGs serving similar populations, beyond expected statistical

  5. Assuring health coverage for all in India.

    Science.gov (United States)

    Patel, Vikram; Parikh, Rachana; Nandraj, Sunil; Balasubramaniam, Priya; Narayan, Kavita; Paul, Vinod K; Kumar, A K Shiva; Chatterjee, Mirai; Reddy, K Srinath

    2015-12-12

    Successive Governments of India have promised to transform India's unsatisfactory health-care system, culminating in the present government's promise to expand health assurance for all. Despite substantial improvements in some health indicators in the past decade, India contributes disproportionately to the global burden of disease, with health indicators that compare unfavourably with other middle-income countries and India's regional neighbours. Large health disparities between states, between rural and urban populations, and across social classes persist. A large proportion of the population is impoverished because of high out-of-pocket health-care expenditures and suffers the adverse consequences of poor quality of care. Here we make the case not only for more resources but for a radically new architecture for India's health-care system. India needs to adopt an integrated national health-care system built around a strong public primary care system with a clearly articulated supportive role for the private and indigenous sectors. This system must address acute as well as chronic health-care needs, offer choice of care that is rational, accessible, and of good quality, support cashless service at point of delivery, and ensure accountability through governance by a robust regulatory framework. In the process, several major challenges will need to be confronted, most notably the very low levels of public expenditure; the poor regulation, rapid commercialisation of and corruption in health care; and the fragmentation of governance of health care. Most importantly, assuring universal health coverage will require the explicit acknowledgment, by government and civil society, of health care as a public good on par with education. Only a radical restructuring of the health-care system that promotes health equity and eliminates impoverishment due to out-of-pocket expenditures will assure health for all Indians by 2022--a fitting way to mark the 75th year of India

  6. Blood wastage management in a regional blood transfusion centre.

    Science.gov (United States)

    Javadzadeh Shahshahani, H; Taghvai, N

    2017-10-01

    The aim of this study was to determine the rate of blood component wastage before and after interventions at Yazd Blood Transfusion Center. The growing need for blood components along with blood safety issues and rising costs constantly pressurise blood centres to improve their efficiency. Reducing the quantity of discarded blood at all stages of the supply chain can decrease the total costs. Data on discarded blood components were extracted from the database of Yazd Blood Transfusion Center. Multiple interventions, including implementation of wastage management standard operating procedures and reduction of red blood cells (RBCs) inventory level, were implemented. Discard rates of blood components in the 3 years after intervention (2013-2015) were compared with the discard rates in the 3 years before interventions. The total wastage rate of blood components decreased by almost 60%. Discard rates of RBCs, platelets and plasma decreased from 9·7%, 18·5% and 5·4% to 2·9%, 10·5% and 2·3%, (P < 0·001) after intervention, respectively. The most prevalent reason for discarding units was expiration of RBCs and platelets. Plasma units were discarded mostly due to technical faults during processing. The cost saving of reduction in blood wastage was estimated to be 1,500,000 dollars. Interventions had a significant impact on the reduction of blood wastage with respect to both cost and blood supply saving. © 2017 British Blood Transfusion Society.

  7. Quality assurance or neo-imperialism

    DEFF Research Database (Denmark)

    Adriansen, Hanne Kirstine; Madsen, Lene Møller

    2013-01-01

    intention to do the opposite. Hence, we want to address how to make quality assurance can be made without imposing Western epistemologies. We call for an appreciation of different knowledges instead of mainstreaming in the name of internationalisation and globalisation. Capacity building of higher education......Capacity building within higher educational institutions in so-called developing countries is gaining momentum and likewise the research field ‘international education and development’. In this paper we address the question: How can we make capacity building of higher education in developing...... in developing countries should ensure a broader perspective of educational quality in order not to lose knowledge diversity and wisdom....

  8. Quality Assurance Framework for Mini-Grids

    Energy Technology Data Exchange (ETDEWEB)

    Esterly, Sean; Baring-Gould, Ian; Booth, Samuel

    2017-05-04

    To address the root challenges of providing quality power to remote consumers through financially viable mini-grids, the Global Lighting and Energy Access Partnership (Global LEAP) initiative of the Clean Energy Ministerial and the U.S. Department of Energy teamed with the National Renewable Energy Laboratory (NREL) and Power Africa to develop a Quality Assurance Framework (QAF) for isolated mini-grids. The framework addresses both alternating current (AC) and direct current (DC) mini-grids, and is applicable to renewable, fossil-fuel, and hybrid systems.

  9. IDENTIFYING PERFORMANCE ASSURANCE CHALLENGES FOR SMART MANUFACTURING.

    Science.gov (United States)

    Helu, Moneer; Morris, Katherine; Jung, Kiwook; Lyons, Kevin; Leong, Swee

    2015-10-01

    Smart manufacturing has the potential to address many of the challenges faced by industry. However, the manufacturing community often needs assistance to leverage available technologies to improve their systems. To assure the performance of these technologies, this paper proposes a shared knowledge base that collects problem areas, solutions, and best practices for manufacturing technology. An Implementation Risk Assessment Framework (IRAF) is also described to identify the primary weaknesses of technologies in specific manufacturing contexts. Such approaches have the potential to stimulate new ideas and drive standardization activities critical to scale up and deploy smart manufacturing technologies successfully and quickly.

  10. Diagnosis of High Blood Pressure

    Medline Plus

    Full Text Available ... Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep Science and Sleep Disorders Lung Diseases Heart and Vascular ... All Science A-Z Grants & Training Grants and ...

  11. Super Safety and Health Day at KSC

    Science.gov (United States)

    2000-01-01

    Employees take a look at this NASCAR auto being displayed during Super Safety and Health Day at KSC. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is '''Safety and Health First.''' KSC's number one goal is to '''Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.'''

  12. HAEMOVIGILANCE AND SAFE BLOOD TRANSFUSION

    Directory of Open Access Journals (Sweden)

    Marjeta Potočnik

    2004-02-01

    Full Text Available Background. Haemovigilance is a system consisting of the detection, collecting and analysis of information regarding unwanted and unexpected effects of blood transfusion that make it possible to take action in order to improve blood trasfusion safety. In a broader sense, it is defined as a set of surveillance procedures covering the whole transfusion chain from the collection of blood to the follow-up of recipients. In some European countries a haemovigilance system based on legislation was introduced during the last ten years, European Haemovigilance Network was organised and some results from the existing surveillance systems were reported. The paper presents haemovigilance activities in Slovenia.Conclusions. In Slovenia, many elements of haemovigilance are already included in the blood transfusion chain, but no unique system of data collection exists. We expect a new legislation on blood transfusion to help us with introducing a data collection system, analysis and activities in order to further improve blood transfusion safety.

  13. Blood Types

    Science.gov (United States)

    ... Teens For Kids For Parents MORE ON THIS TOPIC Is It Possible to Donate Blood After Having Hepatitis B? Health Care: What Do You Know? Donating Blood Blood Transfusions Stem Cell Transplants Contact Us Print Resources Send ...

  14. Architecture Level Safety Analyses for Safety-Critical Systems

    Directory of Open Access Journals (Sweden)

    K. S. Kushal

    2017-01-01

    Full Text Available The dependency of complex embedded Safety-Critical Systems across Avionics and Aerospace domains on their underlying software and hardware components has gradually increased with progression in time. Such application domain systems are developed based on a complex integrated architecture, which is modular in nature. Engineering practices assured with system safety standards to manage the failure, faulty, and unsafe operational conditions are very much necessary. System safety analyses involve the analysis of complex software architecture of the system, a major aspect in leading to fatal consequences in the behaviour of Safety-Critical Systems, and provide high reliability and dependability factors during their development. In this paper, we propose an architecture fault modeling and the safety analyses approach that will aid in identifying and eliminating the design flaws. The formal foundations of SAE Architecture Analysis & Design Language (AADL augmented with the Error Model Annex (EMV are discussed. The fault propagation, failure behaviour, and the composite behaviour of the design flaws/failures are considered for architecture safety analysis. The illustration of the proposed approach is validated by implementing the Speed Control Unit of Power-Boat Autopilot (PBA system. The Error Model Annex (EMV is guided with the pattern of consideration and inclusion of probable failure scenarios and propagation of fault conditions in the Speed Control Unit of Power-Boat Autopilot (PBA. This helps in validating the system architecture with the detection of the error event in the model and its impact in the operational environment. This also provides an insight of the certification impact that these exceptional conditions pose at various criticality levels and design assurance levels and its implications in verifying and validating the designs.

  15. Effectiveness and safety of 1 vs 4 h blood pressure profile with clinical and laboratory assessment for the exclusion of gestational hypertension and pre-eclampsia: a retrospective study in a university affiliated maternity hospital.

    Science.gov (United States)

    McCarthy, Elizabeth Anne; Carins, Thomas A; Hannigan, Yolanda; Bardien, Nadia; Shub, Alexis; Walker, Susan P

    2015-11-18

    We asked whether 60 compared with 240 min observation is sufficiently informative and safe for pregnancy day assessment (PDAC) of suspected pre-eclampsia (PE). A retrospective study of 209 pregnant women (475 PDAC assessments, 6 months) with routinely collected blood pressure (BP), symptom and laboratory information. We proposed a 60 min screening algorithm comprising: absence of symptoms, normal laboratory parameters and ≤1high-BP reading (systolic blood pressure, SBP 140 mm Hg or higher or diastolic blood pressure, DBP 90 mm Hg or higher). We also evaluated two less inclusive screening algorithms. We determined short-term outcomes (within 4 h): severe hypertension, proteinuric hypertension and pregnancy-induced hypertension, as well as long-term outcome: PE-related diagnoses up to the early puerperium. We assessed performance of alternate screening algorithms performance using 2×2 tables. 1 in 3 women met all screen negative criteria at 1 h. Their risk of hypertension requiring treatment in the next 3 h was 1.8% and of failing to diagnose proteinuric hypertensive PE at 4 h was 5.1%. If BP triggers were 5 mm Hg lower, 1 in 6 women would be screen-negative of whom 1.1% subsequently develops treatment-requiring hypertension and 4.5% demonstrate short-term proteinuric hypertension. We present sensitivity, specificity, negative and positive likelihood ratios for alternate screening algorithms. We endorse further research into the safest screening test where women are considered for discharge after 60 min. Safety, patient and staff satisfaction should be assessed prospectively. Any screening test should be used in conjunction with good clinical care to minimise maternal and perinatal hazards of PE. 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/

  16. Vehicle Battery Safety Roadmap Guidance

    Energy Technology Data Exchange (ETDEWEB)

    Doughty, D. H.

    2012-10-01

    The safety of electrified vehicles with high capacity energy storage devices creates challenges that must be met to assure commercial acceptance of EVs and HEVs. High performance vehicular traction energy storage systems must be intrinsically tolerant of abusive conditions: overcharge, short circuit, crush, fire exposure, overdischarge, and mechanical shock and vibration. Fail-safe responses to these conditions must be designed into the system, at the materials and the system level, through selection of materials and safety devices that will further reduce the probability of single cell failure and preclude propagation of failure to adjacent cells. One of the most important objectives of DOE's Office of Vehicle Technologies is to support the development of lithium ion batteries that are safe and abuse tolerant in electric drive vehicles. This Roadmap analyzes battery safety and failure modes of state-of-the-art cells and batteries and makes recommendations on future investments that would further DOE's mission.

  17. Development of public health assurance technology by radiation

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Dong Ho; Lim, Sang Yong; Yang, Jae Seung (and others)

    2007-07-15

    This project was performed to develop the radiation sterilization process of public health products and RT/BT fusion technology and to secure a detection and quarantine system of irradiated food. To establish the radiation sterilization of public health goods, current status of radiation sterilization of disposable medical equipment was investigated and the manufacturing process of disposable media for microbial cultivation were developed using a gamma sterilization. In addition, microbial contamination of disposable kitchen utensils was surveyed and pathogen-free organic compost was developed by radiation sterilization. The radiation responses of bacteria including Salmonella, Vibrio, E. coli, and D. radiodurans were analyzed by DNA chip and 2-D electrophoresis. To validate the safety of surviving bacteria after irradiation, the expressions of virulence genes of pathogenic bacteria were monitored using real-time PCR, and the growth of mycotoxin-producing funguses was studied after irradiation. And also, quantitative detection methods of irradiated and inactivated Salmonella using a real-time PCR and a immuno assay. To establish the quarantine and quality assurance of irradiated food and public health products, radiation technology was applied to the fermented foods, minimally processed food and dried vegetables. Radiation effects on insects was examined and the corresponding data base was constructed. We also collaborated on the preliminary test of international trade of sea food with USA or India. To establish the official detection method of irradiated food, physical, chemical and biological detection methods for irradiated food were verified. Finally, multiple range test of irradiated food was performed.

  18. Quality Assurance and Average Glandular dose Measurement in Mammography Units.

    Science.gov (United States)

    Selvan, C Senthamil; Sureka, C S

    2017-01-01

    To ensure the safe operation of mammography units, acceptance tests and quality assurance (QA) protocols have been developed by the American Association of Physicists in Medicine (AAPM), Engineers Registration Board, and International Atomic Energy Agency. Eight mammography units manufactured by five different manufacturers located in hospitals in our region were investigated following the AAPM and Atomic Energy Regulatory Board (AERB) protocols using a solid-state dosimeter-based PTW-NOMEX Multimeter and a metal-oxide-semiconductor field-effect transistor. This study evaluated different operating parameters through mechanical test, accelerating voltage (kVp) accuracy test, machine output measurement, half-value layer measurement, calibration of compression device, image quality assessment, measurement of leakage radiation, radiation survey, and average glandular dose (AGD) measurements using stereotactic needle biopsy phantom. The results show that out of eight mammography units, only a single mammography unit (U-1) passed all QA tests and 2 units passed 7 tests, 2 units passed 6 tests, and 3 units passed 5 tests out of 8 QA tests. In unit 5, the AGD value was 4 and 1.93 mGy before and after service, respectively. QA programs as recommended by AAPM and AERB should be carried out periodically to ensure safety in breast cancer screening. This work points to the importance of the regulation and effective compliance and also help in both improving the QA and reduce the glandular dose received by the patients.

  19. Blood product costing: relationship to price and clinical efficacy.

    Science.gov (United States)

    Trenchard, P M; Dixon, R

    1995-09-01

    Detailed information is provided about primary product costing and price issues as they affect transfusion manufacturing practice and clinical transfusion practice. Product price is shown to have a crucial influence upon clinical practice and associated research. By focusing particularly upon cost-benefit analysis of blood product transfusion therapy a substantive conclusion is drawn that price should equal the associated manufacturing cost. Clinical outcome studies relate clinical efficacy to the manufacturing specification of the product, which should therefore determine the product cost. Thus, the true manufacturing cost is the sum of all the process activity costs that create the final product specification, e.g. red cell number+volume reduction+leucocyte reduction+microbiological safety, for processed red cells. Sometimes different product specifications may compete for a single activity cost, e.g. one-spin processing achieves volume reduction and leucocyte reduction for processed red cells but also plasma removal for protein fractionation. A method for understanding the relative clinical importance of different products is described, which guides the cost allocation process. Furthermore, for some products there is uncertainty about the clinical benefits of some components of the specification, e.g. leucocyte load and immunomodulation, and a method is described for ranking this quality-uncertainty level objectively. The optimal costing model must ensure that the product with the highest uncertainty ranking is assured a high degree of cost stability. These concepts prepare the way for a Quality Associated Costing model for blood products that correlates with clinical efficacy.

  20. HAEMOVIGILANCE AND SAFE BLOOD TRANSFUSION

    OpenAIRE

    Marjeta Potočnik

    2004-01-01

    Background. Haemovigilance is a system consisting of the detection, collecting and analysis of information regarding unwanted and unexpected effects of blood transfusion that make it possible to take action in order to improve blood trasfusion safety. In a broader sense, it is defined as a set of surveillance procedures covering the whole transfusion chain from the collection of blood to the follow-up of recipients. In some European countries a haemovigilance system based on legislation was i...

  1. Information Assurance in Saudi Organizations - An Empirical Study

    Science.gov (United States)

    Nabi, Syed Irfan; Mirza, Abdulrahman A.; Alghathbar, Khaled

    This paper presents selective results of a survey conducted to find out the much needed insight into the status of information security in Saudi Arabian organizations. The purpose of this research is to give the state of information assurance in the Kingdom and to better understand the prevalent ground realities. The survey covered technical aspects of information security, risk management and information assurance management. The results provide deep insights in to the existing level of information assurance in various sectors that can be helpful in better understanding the intricate details of the prevalent information security in the Kingdom. Also, the results can be very useful for information assurance policy makers in the government as well as private sector organizations. There are few empirical studies on information assurance governance available in literature, especially about the Middle East and Saudi Arabia, therefore, the results are invaluable for information security researchers in improving the understanding of information assurance in this region and the Kingdom.

  2. 78 FR 5813 - 2013 Assuring Radiation Protection

    Science.gov (United States)

    2013-01-28

    ...The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Center for Devices and Radiological Health (CDRH) radiation protection program. The goal of the 2013 Assuring Radiation Protection will be to coordinate Federal, State, and Tribal activities to achieve effective solutions to present and future radiation control problems. The recipient of this cooperative agreement award will be expected to obtain the States' cooperation and participation on committees and working groups established to deal with individual problems. The recipient will also plan and facilitate an annual meeting and develop and offer educational activities to demonstrate mutually beneficial techniques, procedures, and systems relevant to the mission of assuring radiation protection. The recipient will establish committees, in accordance with Federal statutes and regulations, to address, evaluate, and propose solutions for a wide range of radiation health and protection issues. Examples of relevant areas already identified to be of interest include, but are not limited to: (1) The application of x-rays to the healing arts; (2) the application of non-medical ionizing radiation and medical/non- medical non-ionizing radiation; and (3) the control and mitigation of radiation exposure from all sources.

  3. Italian quality assurance in mental health.

    Science.gov (United States)

    Rossi, Giovanni; Agnetti, Germana; Bosio, Roberto; De Luca, Pasquale; Erlicher, Arcadio; Morganti, Carla; Neri, Giovanni; Re, Edoardo; Semisa, Domenico; Fioritti, Angelo

    2014-06-01

    Since the radical changes in Italian mental health law in the 1970s, quality assurance models have gained consensus as the most suitable service assessment tool. In the 1990s, the whole Italian National Health System changed into a corporate model, and an accreditation system was implemented.The Italian Association for Quality and Accreditation in Mental Health (Associazione Italiana per la Qualità e l'Accreditamento in Salute Mentale [QUASM]) was founded in 1984, and since then, it offers consultation and support for Mental Health Departments and Regional Governments to help them to develop psychiatric programs, self-evaluation, educational programs, and professional peer-model accreditation. The QUASM accreditation manual has now gone through several revisions, the last in 2008. Until 2008, QUASM was successful in promoting quality and facilitating both institutional and professional accreditation. However, radical changes triggered by financial crisis have jeopardized quality assurance implementation. Nowadays, the challenge for QUASM is to maintain quality and accreditation geared to excellence against prevailing leveling trends.

  4. Model Based Mission Assurance in a Model Based Systems Engineering (MBSE) Framework: State-of-the-Art Assessment

    Science.gov (United States)

    Cornford, Steven L.; Feather, Martin S.

    2016-01-01

    This report explores the current state of the art of Safety and Mission Assurance (S&MA) in projects that have shifted towards Model Based Systems Engineering (MBSE). Its goal is to provide insight into how NASA's Office of Safety and Mission Assurance (OSMA) should respond to this shift. In MBSE, systems engineering information is organized and represented in models: rigorous computer-based representations, which collectively make many activities easier to perform, less error prone, and scalable. S&MA practices must shift accordingly. The "Objective Structure Hierarchies" recently developed by OSMA provide the framework for understanding this shift. Although the objectives themselves will remain constant, S&MA practices (activities, processes, tools) to achieve them are subject to change. This report presents insights derived from literature studies and interviews. The literature studies gleaned assurance implications from reports of space-related applications of MBSE. The interviews with knowledgeable S&MA and MBSE personnel discovered concerns and ideas for how assurance may adapt. Preliminary findings and observations are presented on the state of practice of S&MA with respect to MBSE, how it is already changing, and how it is likely to change further. Finally, recommendations are provided on how to foster the evolution of S&MA to best fit with MBSE.

  5. Internal auditing and organizational governance : the combined assurance approach

    OpenAIRE

    Decaux, Loïc

    2015-01-01

    If risk is everywhere, why is not assurance? This is an especially important question for boards of directors since they are often required to attest the effectiveness and appropriateness of internal control and risk management systems, but how can a board do so without receiving holistic assurance? This dissertation tries to provide elements of solution by developing four essays around the concept of combined assurance. Originally introduced by The King III Report in South Africa, combined a...

  6. The quest for quality blood banking program in the new millennium the American way.

    Science.gov (United States)

    Kim, Dae Un

    2002-08-01

    For an industry to succeed and satisfy its customers, "QUALITY" must be a primary goal. Quality has been central to blood banking from its inception, with the evolution of a Quality Program since the opening of the first blood bank in U.S. at the Cook County Hospital in 1937. Over the ensuing decades, continuous scientific progress in blood preservation, filters, viral and blood group testing, crossmatching, automation, and computerization including bar coding, etc. has contributed to the quality and safety of the blood products and transfusion service. However, with the advent of the AIDS era, an increasingly sensitized and informed public is continuously demanding that the highest level of quality be achieved and maintained in all processes involved in providing all blood products. The Food and Drug Administration (FDA) introduced the concept of a "zero risk blood supply" as the industry goal. Furthermore, the cost containment and resource-constrained environment have changed the complexity of the quality practice. Both regulatory agencies such as the FDA, the Health Care Financing Administration [HCFA, which was recently renamed as the Centers for Medicare and Medicaid Services (CMS) in July, 2001], and the State Department of Health, and accrediting agencies, such as the American Association of Blood Banks (AABB), the College of American Pathologists (CAP), and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), require blood banks and transfusion services to establish and follow a Quality Control and Quality Assurance Program for their licensing, certification and accreditation. Every laboratory has to comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) quality requirements being implemented by the CMS. The FDA guidelines assist facilities in compliance with Current Good Manufacturing Practices (cGMP). The AABB's Quality System Essentials (QSE) are based on these specifications and provide additional guidance in

  7. Blood Facts and Statistics

    Science.gov (United States)

    ... Blood > Blood Facts and Statistics Blood Facts and Statistics Facts about blood needs Facts about the blood ... to Top Learn About Blood Blood Facts and Statistics Blood Components Whole Blood and Red Blood Cells ...

  8. Understanding What It Means for Assurance Cases to "Work"

    Science.gov (United States)

    Rinehart, David J.; Knight, John C.; Rowanhill, Jonathan

    2017-01-01

    This report is the result of our year-long investigation into assurance case practices and effectiveness. Assurance cases are a method for working toward acceptable critical system performance. They represent a significant thread of applied assurance methods extending back many decades and being employed in a range of industries and applications. Our research presented in this report includes a literature survey of over 50 sources and interviews with nearly a dozen practitioners in the field. We have organized our results into seven major claimed assurance case benefits and their supporting mechanisms, evidence, counter-evidence, and caveats.

  9. A Review of Function Allocation and En Route Separation Assurance

    Science.gov (United States)

    Lewis, Timothy A.; Aweiss, Arwa S.; Guerreiro, Nelson M.; Daiker, Ronald J.

    2016-01-01

    Today's air traffic control system has reached a limit to the number of aircraft that can be safely managed at the same time. This air traffic capacity bottleneck is a critical problem along the path to modernization for air transportation. The design of the next separation assurance system to address this problem is a cornerstone of air traffic management research today. This report reviews recent work by NASA and others in the areas of function allocation and en route separation assurance. This includes: separation assurance algorithms and technology prototypes; concepts of operations and designs for advanced separation assurance systems; and specific investigations into air-ground and human-automation function allocation.

  10. 10 CFR 63.144 - Quality assurance program change.

    Science.gov (United States)

    2010-01-01

    ... administrative improvements and clarifications, spelling corrections, punctuation, or editorial items, the... correct spelling, punctuation, or editorial items). (3) DOE shall maintain records of quality assurance...

  11. Challenges in Data Quality Assurance in Pervasive Health Monitoring Systems

    Science.gov (United States)

    Sriram, Janani; Shin, Minho; Kotz, David; Rajan, Anand; Sastry, Manoj; Yarvis, Mark

    Wearable, portable, and implantable medical sensors have ushered in a new paradigm for healthcare in which patients can take greater responsibility and caregivers can make well-informed, timely decisions. Health-monitoring systems built on such sensors have huge potential benefit to the quality of healthcare and quality of life for many people, such as patients with chronic medical conditions (such as blood-sugar sensors for diabetics), people seeking to change unhealthy behavior (such as losing weight or quitting smoking), or athletes wishing to monitor their condition and performance. To be effective, however, these systems must provide assurances about the quality of the sensor data. The sensors must be applied to the patient by a human, and the sensor data may be transported across multiple networks and devices before it is presented to the medical team. While no system can guarantee data quality, we anticipate that it will help for the system to annotate data with some measure of confidence. In this paper, we take a deeper look at potential health-monitoring usage scenarios and highlight research challenges required to ensure and assess quality of sensor data in health-monitoring systems.

  12. Order of blood draw

    DEFF Research Database (Denmark)

    Cornes, Michael; van Dongen-Lases, Edmée; Grankvist, Kjell

    2017-01-01

    , CLSI) guidelines recommend that the order of draw of blood during phlebotomy should be blood culture/sterile tubes, then plain tubes/gel tubes, then tubes containing additives. This prevents contamination of sample tubes with additives from previous tubes that could cause erroneous results. There have...... Medicine Working Group for the Preanalytical Phase (EFLM WG-PRE) provides an overview and summary of the literature with regards to order of draw in venous blood collection. Given the evidence presented in this article, the EFLM WG-PRE herein concludes that a significant frequency of sample contamination...... does occur if order of draw is not followed during blood collection and when performing venipuncture under less than ideal circumstances, thus putting patient safety at risk. Moreover, given that order of draw is not difficult to follow and knowing that ideal phlebotomy conditions and protocols...

  13. Auto Safety

    Science.gov (United States)

    ... to Talk to Your Child About the News Gun Safety Too Late for the Flu Vaccine? Eating ... many local health departments, public safety groups, hospitals, law enforcement agencies, and fire departments have technicians or ...

  14. Water Safety

    Science.gov (United States)

    ... School Counselors Kidney Stones Brain and Nervous System Water Safety KidsHealth > For Teens > Water Safety Print A ... tied to alcohol use. previous continue At the Water Park OK, so you do more splashing than ...

  15. Safety Plan

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — The Swan Lake National Wildlife Refuge Safety Plan discusses policies for the safety of the station employees, volunteers, and public. This plan seeks to identify...

  16. Water Safety

    Science.gov (United States)

    ... Staying Safe Videos for Educators Search English Español Water Safety KidsHealth / For Parents / Water Safety What's in ... remains your best measure of protection. Making Kids Water Wise It's important to teach your kids proper ...

  17. Is the Blood Donated by Habitual Nut Quid Chewers Suitable for Use in Transfusion?

    Directory of Open Access Journals (Sweden)

    Kuang-Ping Peng

    2010-02-01

    Conclusion: We suggest that to assure the quality of transfusion, the blood donated by a habitual BQ chewer should be used with caution because of its possible contamination with areca nut ingredients that may be cytotoxic to RBCs.

  18. Best practices in regulation of blood and blood products.

    Science.gov (United States)

    Epstein, Jay S

    2012-05-01

    The need for blood regulation arises from the inherent risks of blood transfusion, which are minimized through implementation of standards. Regulatory oversight is advocated by the World Health Organization (WHO) as an essential element of any blood system to ensure such standards are met. The WHO Blood Regulators Network has developed "Assessment Criteria for National Blood Regulatory Systems" that describe the legal authority and functions of a fully competent blood regulator. The core functions include licensing and/or registration of blood establishments, marketing approval of blood products, oversight of all associated substances and devices, control of clinical trials, access to an independent laboratory for product assessments, lot release, and hemovigilance systems. Regulatory policy-making for blood safety is needed to address emerging threats, to consider the risks and benefits of new products and technologies, and to respond to adverse events. Structured policy-making processes are essential to ensure that decisions are science-based, with appropriate consideration of relevant economic and social factors. Decision making is especially challenging in situations of scientific uncertainty, where prudent precautionary measures may be appropriate based on assessments of risk and feasibility of meaningful interventions. There is international interest in finding a common framework for addressing blood safety decisions. Published by Elsevier Ltd.

  19. Model-Driven Development of Safety Architectures

    Science.gov (United States)

    Denney, Ewen; Pai, Ganesh; Whiteside, Iain

    2017-01-01

    We describe the use of model-driven development for safety assurance of a pioneering NASA flight operation involving a fleet of small unmanned aircraft systems (sUAS) flying beyond visual line of sight. The central idea is to develop a safety architecture that provides the basis for risk assessment and visualization within a safety case, the formal justification of acceptable safety required by the aviation regulatory authority. A safety architecture is composed from a collection of bow tie diagrams (BTDs), a practical approach to manage safety risk by linking the identified hazards to the appropriate mitigation measures. The safety justification for a given unmanned aircraft system (UAS) operation can have many related BTDs. In practice, however, each BTD is independently developed, which poses challenges with respect to incremental development, maintaining consistency across different safety artifacts when changes occur, and in extracting and presenting stakeholder specific information relevant for decision making. We show how a safety architecture reconciles the various BTDs of a system, and, collectively, provide an overarching picture of system safety, by considering them as views of a unified model. We also show how it enables model-driven development of BTDs, replete with validations, transformations, and a range of views. Our approach, which we have implemented in our toolset, AdvoCATE, is illustrated with a running example drawn from a real UAS safety case. The models and some of the innovations described here were instrumental in successfully obtaining regulatory flight approval.

  20. Reliability-based assessment of flow assurance of hot waxy crude pipelines

    Energy Technology Data Exchange (ETDEWEB)

    Jinjun, Zhang; Wenke, Zhang; Jianlin, Ding; Bo, Yu [China University of Petroleum - Beijing (CUPB), Beijing (China)

    2009-07-01

    Waxy crude is characterized by its high pour point. Pipeline blockage may occur after prolonged shutdown of a pipeline due to crude oil gelation. Another flow assurance problem is the instable operation at a flow rate below the lowest allowable operation flow rate which is dependent on heat transfer of the pipeline and the viscosity vs. temperature relation of the crude pumped. Besides, for pipelines with thick wax deposition layer, massive depletion of wax deposit in some cases such as pipeline restart at high expelling pressure may also result in blockage of the pipeline, and the pig may be jammed during pigging as a result of thick wax deposition. Conventionally, assessment of these risks has been made by using the deterministic approach. However, many related physical quantities are subject to uncertainty and contribute to reliability of flow assurance. Therefore, the probabilistic approach is suggested and a framework of reliability based assessment of flow assurance of waxy crude pipelines is proposed in this paper. Discussions are also made on the limit state functions and target safety level. In the future study, development of an efficient and robust stochastic-numerical method is crucial. (author)

  1. SAPHIRE 8 Volume 6 - Quality Assurance

    Energy Technology Data Exchange (ETDEWEB)

    C. L. Smith; R. Nims; K. J. Kvarfordt

    2011-03-01

    The Systems Analysis Programs for Hands-on Integrated Reliability Evaluations (SAPHIRE) Version 8 is a software application developed for performing a complete probabilistic risk assessment using a personal computer running the Microsoft Windows™ operating system. SAPHIRE 8 is funded by the U.S. Nuclear Regulatory Commission (NRC). The role of the INL in this project is that of software developer and tester. This development takes place using formal software development procedures and is subject to quality assurance (QA) processes. The purpose of this document is to describe how the SAPHIRE software QA is performed for Version 8, what constitutes its parts, and limitations of those processes. In addition, this document describes the Independent Verification and Validation that was conducted for Version 8 as part of an overall QA process.

  2. High-Assurance Software: LDRD Report.

    Energy Technology Data Exchange (ETDEWEB)

    Hulette, Geoffrey Compton

    2014-06-01

    This report summarizes our work on methods for developing high-assurance digital systems. We present an approach for understanding and evaluating trust issues in digital systems, and for us- ing computer-checked proofs as a means for realizing this approach. We describe the theoretical background for programming with proofs based on the Curry-Howard correspondence, connect- ing the field of logic and proof theory to programs. We then describe a series of case studies, intended to demonstrate how this approach might be adopted in practice. In particular, our stud- ies elucidate some of the challenges that arise with this style of certified programming, including induction principles, generic programming, termination requirements, and reasoning over infinite state spaces.

  3. Exercise in Quality Assurance: A Laboratory Exercise

    DEFF Research Database (Denmark)

    Andersen, Jens Enevold Thaulov

    2009-01-01

    In recent years there has been additional focus on quality assurance in analytical chemistry, and the effort must be supported by teaching and presentation of some of the novel tools of statistics (1–6). It has been long recognized that linear calibration is not as simple as anticipated when...... uncertainties are taken into consideration (2–4). Frequently, the familiar coefficient of correlation is associated with quality of analytical results but it does not provide much information on the uncertainty of an unknown. Thus, to estimate uncertainties on measurements, more delicate tools of statistics...... are required (7–9). It is imperative that the predicted uncertainties of calibrations correspond exactly to the uncertainties obtained by repetitive measurements of unknowns. However, as shown by the present analysis, the uncertainties of calibrations by the law of propagation of errors (LPE) correspond well...

  4. F-35 Engine Quality Assurance Inspection

    Science.gov (United States)

    2015-04-27

    found in the F -15 Eagle, F -16 Fighting Falcon , F -22 Raptor, F -35 Lightning II, C-17 Globemaster III military transport, and Boeing’s KC-46 tanker...I N T E G R I T Y  E F F I C I E N C Y  A C C O U N TA B I L I T Y  E XC E L L E N C E Inspector General U.S. Department of Defense A P...R I L 2 7 , 2 0 1 5 F -35 Engine Quality Assurance Inspection Report No. DODIG-2015-111 FOR OFFICIAL USE ONLY FOR OFFICIAL USE ONLY The document

  5. Epidemiology of Hepatitis C Virus in the private blood banking ...

    African Journals Online (AJOL)

    Background: Hepatitis C Virus (HCV) is an agent of Transfusion Transmissible Infection (TTI) which serves as a threat to blood safety and sufficiency of blood and blood products supply. Objectives: This study aimed at determining the distribution patterns of HCV among potential blood donors in a private Blood Bank in ...

  6. Blood transfusion: risks and indications | Schoeman | Obstetrics and ...

    African Journals Online (AJOL)

    Blood transfusions are governed by the Human Tissue Act. Blood users and providers should be aware of their legal and clinical responsibility when using blood and blood products. The safety of blood products cannot be guaranteed and an inherent risk remains when using these products. All efforts should be made to ...

  7. Fire safety

    Science.gov (United States)

    Robert H. White; Mark A. Dietenberger

    1999-01-01

    Fire safety is an important concern in all types of construction. The high level of national concern for fire safety is reflected in limitations and design requirements in building codes. These code requirements are discussed in the context of fire safety design and evaluation in the initial section of this chapter. Since basic data on fire behavior of wood products...

  8. Topaz II preliminary safety assessment

    Science.gov (United States)

    Marshall, Albert C.; Standley, Vaughn; Voss, Susan S.; Haskin, Eric

    1993-01-01

    The Strategic Defense Initiative Organization (SDIO) decided to investigate the possibility of launching a Russian Topaz II space nuclear power system. A preliminary safety assessment was conducted to determine whether or not a space mission could be conducted safely and within budget constraints. As part of this assessment, a safety policy and safety functional requirements were developed to guide both the safety assessment and future Topaz II activities. A review of the Russian flight safety program was conducted and documented. Our preliminary safety assessment included a top level event tree, neutronic analysis of normal and accident configurations, an evaluation of temperature coefficients of reactivity, a reentry and disposal analysis, and analysis of postulated launch abort impact accidents, and an analysis of postulated propellant fire and explosion accidents. Based on the assessment, it appears that it will be possible to safely launch the Topaz II system in the U.S. with some possible system modifications. The principal system modifications will probably include design changes to preclude water flooded criticality and to assure intact reentry.

  9. Assuring the research competence of orthopedic graduates.

    Science.gov (United States)

    Konstantakos, Emmanuel K; Laughlin, Richard T; Markert, Ronald J; Crosby, Lynn A

    2010-01-01

    To assure that orthopaedic residents have the knowledge needed to critically appraise the medical/surgical literature and the skills needed to design and conduct musculoskeletal and orthopaedic research. Residency program of the Department of Orthopaedic Surgery, Sports Medicine and Rehabilitation at Wright State University Boonshoft School of Medicine, Dayton, Ohio. Established in 2005, members of the residency program's Research Team (RT) include orthopaedic faculty and residents, university faculty and graduate students, community scientists, and department staff. The membership and responsibilities of the Research Team are described. The goals of the three-month research rotation during the second year of residency and the activities of the assigned resident are reported. The work of the two research residents during the second year of their six-year program is explained. Helpful educational resources are noted, the role of the faculty research mentor defined, funding sources listed, and the financial support for RT members and research staff presented. The scholarly activity of orthopaedic surgery residents increased substantially from the five-year period before the implementation of the Research Team (September 2000 through August 2005) to the four-year period after initiation of the RT (September 2005 through November 2009). For peer-reviewed scholarship activity, publications on which residents were authors increased from 1 to 10 per year, national presentations at professional meetings increased from 6 to 11 per year, and local and regional presentations increased from 2 to 4 per year. The Research Team is an effective strategy for assuring that orthopaedic residents have the knowledge and skills to evaluate clinical care evidence and to conduct musculoskeletal and orthopaedic research. Copyright (c) 2010 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  10. Airline Safety: A Comparative Analysis.

    Science.gov (United States)

    1987-01-01

    S.TP OFR O T PEIDCV E Airline Safety: A Comparative Analysis TRlES IS1j0’~fJ 6. PERFORMING 01G. REPORT NUMBER AU TNOR( ) Sign . CONTRACT OR GRANT NUMBER...accidents. Perhaps because of an airline’s understandable sensitivity to public knowledge of its accidents, one has little assurance that each airline...62,169 0 Royal Air Maroc 81,451 0 80,861 0 (Morocco) Royal Nepal 11,885 0 19,785 0 SAA (South Africa) 57,226 0 61,618 0 SAHSA (Honduras) 32,658 0 34,894 0

  11. Can the Analytical Hierarchy Process Model Be Effectively Applied in the Prioritization of Information Assurance Defense In-Depth Measures? --A Quantitative Study

    Science.gov (United States)

    Alexander, Rodney T.

    2017-01-01

    Organizational computing devices are increasingly becoming targets of cyber-attacks, and organizations have become dependent on the safety and security of their computer networks and their organizational computing devices. Business and government often use defense in-depth information assurance measures such as firewalls, intrusion detection…

  12. Lexique risque sécurité, financement, assurance, réassurance

    CERN Document Server

    Lesobre, Jacques; Cave, Frances J.

    2008-01-01

    La mondialisation fait de la maîtrise du risque un enjeu majeur pour la pérennité et le développement de l'activité économique à l'échelle planétaire. Le lexique risque - français, anglais et américain, s'inscrit pleinement dans cette perspective. Avec plus de 12 000 termes et locutions et 3 000 abréviations et sigles, il répond aux incertitudes et incompréhensions terminologiques en matière de sécurité, de prévention, d'analyse et de contrôle des risques (y compris financiers), d'assurance et de réassurance. Les termes, même les plus ésotériques, sont désormais à votre portée.

  13. Fire safety assessment of tunnel structures

    DEFF Research Database (Denmark)

    Gkoumas, Konstantinos; Giuliani, Luisa; Petrini, Francesco

    2011-01-01

    durability provisions, commitment to environmental aspects, issues of sustainability and safety assurance, for their whole lifecycle. The design for safety of tunnel infrastructures is a multifaceted process, since there are many aspects that need to be accounted for, regarding different aspects (e.......g. structural and non structural, organizational, human behavior). This is even more truth for the fire safety design of such structures. Fire safety in tunnels is challenging because of the particular environment, bearing in mind also that a fire can occur in different phases of the tunnel’s lifecycle. Plans...... for upgrading fire safety provisions and tunnel management are also important for existing tunnels. In this study, following a brief introduction of issues regarding the above mentioned aspects, the structural performance of a steel rib for a tunnel infrastructure subject to fire is assessed by means...

  14. Construction Safety for the National Ignition Facility

    Energy Technology Data Exchange (ETDEWEB)

    Predmore, R

    2000-09-01

    This Construction Safety Program (CSP) for the National Ignition Facility (NIF) presents safety protocols and guidelines that management and workers shall follow to assure a safe and healthful work environment. Appendix A, a separate companion document, includes further applicable environmental, safety, and health requirements for the NIF Project. Specifically this document: {sm_bullet} Defines the fundamental site safety philosophy, {sm_bullet} Identifies management roles and responsibilities, {sm_bullet} Defines core safety management processes, {sm_bullet} Identifies LLNL institutional requirements, and {sm_bullet} Defines the functional areas and facilities accrued by the program and the process for transition of facilities, functional areas, and/or systems from construction to activation. Anyone willfully or thoughtlessly disregarding standards will be subject to immediate removal from the site. Thorough job planning will help ensure that these standards are met.

  15. 21 CFR 892.1940 - Radiologic quality assurance instrument.

    Science.gov (United States)

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1940 Radiologic quality assurance instrument. (a) Identification. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device. (b) Classification...

  16. 75 FR 57274 - Financial Management and Assurance; Government Auditing Standards

    Science.gov (United States)

    2010-09-20

    ... OFFICE Financial Management and Assurance; Government Auditing Standards AGENCY: Government...Jlowbookgao.gov . Public Law 67-13, 42 Stat. 20. James R. Dalkin, Director, Financial Management and Assurance... necessary changes. The Advisory Council includes experts in financial and performance auditing drawn from...

  17. 42 CFR 440.390 - Assurance of transportation.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Assurance of transportation. 440.390 Section 440...-Equivalent Coverage § 440.390 Assurance of transportation. If a benchmark or benchmark-equivalent plan does not include transportation to and from medically necessary covered Medicaid services, the State must...

  18. 42 CFR 431.53 - Assurance of transportation.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Assurance of transportation. 431.53 Section 431.53... Requirements § 431.53 Assurance of transportation. A State plan must— (a) Specify that the Medicaid agency will ensure necessary transportation for recipients to and from providers; and (b) Describe the methods that...

  19. Quality Assurance of E-learning. ENQA Workshop Report 14

    Science.gov (United States)

    Grifoll, Josep; Huertas, Esther; Prades, Anna; Rodriguez, Sebastian; Rubin, Yuri; Mulder, Fred; Ossiannilsson, Ebba

    2010-01-01

    E-learning in the European Higher Education Area has stampeded its way to the foreground of the Quality Assurance (QA) forum, and has become a key issue among quality assurance agencies and institutions in the European Higher Education Area (EHEA). Because internet-based learning is currently such a relevant topic, there is a dire need for the…

  20. Quality Assurance in Higher Education: A Review of Literature

    Science.gov (United States)

    Ryan, Tricia

    2015-01-01

    This paper examines the literature surrounding quality assurance in global higher education. It provides an overview of accreditation as a mechanism to ensure quality in higher education, examines models of QA, and explores the concept of quality (including definitions of quality and quality assurance). In addition, this paper provides a review of…

  1. A Rotational Blended Learning Model: Enhancement and Quality Assurance

    Science.gov (United States)

    Ghoul, Said

    2013-01-01

    Research on blended learning theory and practice is growing nowadays with a focus on the development, evaluation, and quality assurance of case studies. However, the enhancement of blended learning existing models, the specification of their online parts, and the quality assurance related specifically to them have not received enough attention.…

  2. 76 FR 51357 - Notice of Availability: American Assured Fuel Supply

    Science.gov (United States)

    2011-08-18

    ... of Availability: American Assured Fuel Supply AGENCY: The U.S. Department of Energy. ACTION: Notice of availability. SUMMARY: The U.S. Department of Energy (DOE) is creating the American Assured Fuel Supply (AFS), a reserve of low enriched uranium (LEU) to serve as a backup fuel supply for foreign...

  3. Quality Assurance and Accreditation of Engineering Education in Jordan

    Science.gov (United States)

    Aqlan, Faisal; Al-Araidah, Omar; Al-Hawari, Tarek

    2010-01-01

    This paper provides a study of the quality assurance and accreditation in the Jordanian higher education sector and focuses mainly on engineering education. It presents engineering education, accreditation and quality assurance in Jordan and considers the Jordan University of Science and Technology (JUST) for a case study. The study highlights the…

  4. Quality Assurance of Joint Programmes. ENQA Workshop Report 19

    Science.gov (United States)

    Frederiks, Mark; Grifoll, Josep; Hiltunen, Kirsi; Hopbach, Achim

    2012-01-01

    In view of the Bologna ministerial conference to be held in April 2012 in Bucharest, ENQA organised a seminar in September 2011 on Quality Assurance of Joint Programmes in collaboration with the Austrian Accreditation Council (OAR). The purpose of this seminar was twofold: first, to analyse the experience already gained in quality assurance of…

  5. Process of Assuring Quality in Counselling at the National Open ...

    African Journals Online (AJOL)

    The main aim of such research is to explore the possibilities of making the process of counselling interaction more learner centred, learner friendly and quality assured using Six Sigma Quality Assurance model. The paper therefore discusses the concept of open and distance education, alongside with the mission statement ...

  6. Quality Assurance in Distance Education and eLearning ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    2013-01-24

    Jan 24, 2013 ... This book documents the regulatory framework covering quality assurance in distance education in several Asian countries. It draws on the experience of 16 distance education and e-learning institutions to reveal their main challenges in developing quality assurance systems. While offering solutions to ...

  7. Illinois' Forests, 2005: Statistics, Methods, and Quality Assurance

    Science.gov (United States)

    Susan J. Crocker; Charles J. Barnett; Mark A. Hatfield

    2013-01-01

    The first full annual inventory of Illinois' forests was completed in 2005. This report contains 1) descriptive information on methods, statistics, and quality assurance of data collection, 2) a glossary of terms, 3) tables that summarize quality assurance, and 4) a core set of tabular estimates for a variety of forest resources. A detailed analysis of inventory...

  8. Quality Assurance Systems in Open and Distance Learning: A ...

    African Journals Online (AJOL)

    This article seeks to explore the role and importance of quality assurance systems in open and distance learning mode. The article begins with the introduction of quality assurance and proceeds with the definition and meaning of quality which is very complex to define. The author further proceeds to trace the history and ...

  9. Internal Quality Assurance Benchmarking. ENQA Workshop Report 20

    Science.gov (United States)

    Blackstock, Douglas; Burquel, Nadine; Comet, Nuria; Kajaste, Matti; dos Santos, Sergio Machado; Marcos, Sandra; Moser, Marion; Ponds, Henri; Scheuthle, Harald; Sixto, Luis Carlos Velon

    2012-01-01

    The Internal Quality Assurance group of ENQA (IQA Group) has been organising a yearly seminar for its members since 2007. The main objective is to share experiences concerning the internal quality assurance of work processes in the participating agencies. The overarching theme of the 2011 seminar was how to use benchmarking as a tool for…

  10. 10 CFR 830.121 - Quality Assurance Program (QAP).

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Quality Assurance Program (QAP). 830.121 Section 830.121... Assurance Program (QAP). (a) Contractors conducting activities, including providing items or services, that... must: (1) Submit a QAP to DOE for approval and regard the QAP as approved 90 days after submittal...

  11. 40 CFR 280.112 - Drawing on financial assurance mechanisms.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 26 2010-07-01 2010-07-01 false Drawing on financial assurance... OF UNDERGROUND STORAGE TANKS (UST) Financial Responsibility § 280.112 Drawing on financial assurance... agency may draw on a standby trust fund when: (1) The Director makes a final determination that a release...

  12. Quality Assurance in Distance Education and eLearning ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    24 janv. 2013 ... Quality Assurance in Distance Education and eLearning : Challenges and Solutions from Asia. Couverture du livre Quality Assurance in Distance Education and eLearning : Challenges and Solutions from Asia. Directeur(s) : Insung Jung, Tat Meng Wong et Tian Belawati. Maison(s) d'édition : SAGE, CRDI.

  13. Product assurance policies and procedures for flight dynamics software development

    Science.gov (United States)

    Perry, Sandra; Jordan, Leon; Decker, William; Page, Gerald; Mcgarry, Frank E.; Valett, Jon

    1987-01-01

    The product assurance policies and procedures necessary to support flight dynamics software development projects for Goddard Space Flight Center are presented. The quality assurance and configuration management methods and tools for each phase of the software development life cycles are described, from requirements analysis through acceptance testing; maintenance and operation are not addressed.

  14. Quality assurance and evidence in career guidance in Europe

    DEFF Research Database (Denmark)

    Plant, Peter

    2011-01-01

    Quality assurance and evidence in career guidance in Europe is based on a particular, positivtic model. Other approaches are largely neglected.......Quality assurance and evidence in career guidance in Europe is based on a particular, positivtic model. Other approaches are largely neglected....

  15. Quality Assurance Program Plan for radionuclide airborne emissions monitoring

    Energy Technology Data Exchange (ETDEWEB)

    Vance, L.M.

    1993-07-01

    This Quality Assurance Program Plan (QAPP) describes the quality assurance requirements and responsibilities for radioactive airborne emissions measurements activities from regulated stacks are controlled at the Hanford Site. Detailed monitoring requirements apply to stacks exceeding 1% of the standard of 10 mrem annual effective dose equivalent to the maximally exposed individual from operations of the Hanford Site.

  16. The Landscape of Quality Assurance in Distance Education

    Science.gov (United States)

    Scull, W. Reed; Kendrick, David; Shearer, Rick; Offerman, Dana

    2011-01-01

    Distance education permeates the field of professional and continuing education to such an extent that quality assurance (QA) is a topic no distance educator or administrator should avoid. Quality assurance is an issue not just for continuing education but also for higher education generally. Given the disruptive impact of distance education and…

  17. Teachers' motivation and its influence on quality assurance in the ...

    African Journals Online (AJOL)

    Highlighted in the paper are definitions of some terms and the significance of teachers' motivation and quality assurance to the Nigerian educational system. Different motivational theories were also highlighted in the paper in order to show the nexus between teacher motivation and quality assurance. The paper also ...

  18. Evaluation of the efficacy and safety of the ophthalmic insert Mydriasert in patients undergoing retinal angiography.

    Science.gov (United States)

    Cagini, Carlo; Caricato, Anna; Tosi, Gianluigi; Pascale, Angelo; Cesari, Claudia; Fiore, Tito

    2014-01-01

    To verify the efficacy to obtain mydriasis and cardiovascular safety of Mydriasert (ophthalmic insert containing tropicamide and phenylephrine) in diabetic and nondiabetic patients undergoing retinal angiography by comparing it with usually administered eyedrops (tropicamide 1% and phenylephrine 10%). This was a prospective randomized study. A total of 154 eyes of 77 patients were randomly divided into 2 groups: group 1 consisted of 78 eyes, group 2 consisted of 76 eyes, and the patients were monitored for pupillary dilation, blood pressure, heart rate, and possible adverse effects at 0, 20, 40, 60, and 90 minutes. No severe adverse effects were observed in either group. In the entire sample studied, the mean pupillary diameter was greater in the eyedrops group after 20 and 40 minutes, while mydriasis was similar in the 2 groups after 60 minutes. The diabetic patients treated with Mydriasert had less mydriasis than those treated with eyedrops after 20 and 40 minutes, and diabetic patients showed less mydriasis than the nondiabetic patients after 60 and 90 minutes. There was no significant between-group difference in mean heart rate or systolic and diastolic blood pressure at any of the time points. Mydriasert assures an adequate degree of mydriasis for retinal angiography in both diabetic and nondiabetic patients. There are no differences in efficacy or safety between the insert and the usually administered eyedrops, but the low total drug dose administered with the insert reduces the risk of cardiovascular side effects.

  19. Concept of Draft International Standard for a Unified Approach to Space Program Quality Assurance

    Science.gov (United States)

    Stryzhak, Y.; Vasilina, V.; Kurbatov, V.

    2002-01-01

    For want of the unified approach to guaranteed space project and product quality assurance, implementation of many international space programs has become a challenge. Globalization of aerospace industry and participation of various international ventures with diverse quality assurance requirements in big international space programs requires for urgent generation of unified international standards related to this field. To ensure successful fulfillment of space missions, aerospace companies should design and process reliable and safe products with properties complying or bettering User's (or Customer's) requirements. Quality of the products designed or processed by subcontractors (or other suppliers) should also be in compliance with the main user (customer)'s requirements. Implementation of this involved set of unified requirements will be made possible by creating and approving a system (series) of international standards under a generic title Space Product Quality Assurance based on a system consensus principle. Conceptual features of the baseline standard in this system (series) should comprise: - Procedures for ISO 9000, CEN and ECSS requirements adaptation and introduction into space product creation, design, manufacture, testing and operation; - Procedures for quality assurance at initial (design) phases of space programs, with a decision on the end product made based on the principle of independence; - Procedures to arrange incoming inspection of products delivered by subcontractors (including testing, audit of supplier's procedures, review of supplier's documentation), and space product certification; - Procedures to identify materials and primary products applied; - Procedures for quality system audit at the component part, primary product and materials supplier facilities; - Unified procedures to form a list of basic performances to be under configuration management; - Unified procedures to form a list of critical space product components, and unified

  20. Develpment of quality assurance manual for fabrication of DUPIC fuel

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Young Gun; Lee, J. W.; Kim, S. S. and others

    2001-09-01

    The Quality Assurance Manual for the fabrication of DUPIC fuel with high quality was developed. The Quality Assurance Policy established by this manual is to assure that the DUPIC fuel element supplied to customer conform to the specified requirements of customer, applicable codes and standards. The management of KAERI is committed to implementation and maintenance of the program described by this manual. This manual describes the quality assurance program for DUPIC fuel fabrication to comply with CAN3-Z299.2-85 to the extent as needed and appropriate. This manual describes the methods which DUPIC Fuel Development Team(DFDT) personnel must follow to achieve and assure high quality of our product. This manual also describes the quality management system applicable to the activities performed at DFDT.