WorldWideScience

Sample records for assuring blood safety

  1. Reactor system safety assurance

    International Nuclear Information System (INIS)

    Mattson, R.J.

    1984-01-01

    The philosophy of reactor safety is that design should follow established and conservative engineering practices, there should be safety margins in all modes of plant operation, special systems should be provided for accidents, and safety systems should have redundant components. This philosophy provides ''defense in depth.'' Additionally, the safety of nuclear power plants relies on ''safety systems'' to assure acceptable response to design basis events. Operating experience has shown the need to study plant response to more frequent upset conditions and to account for the influence of operators and non-safety systems on overall performance. Defense in depth is being supplemented by risk and reliability assessment

  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. 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

  4. 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...

  5. Improving patient safety through quality assurance.

    Science.gov (United States)

    Raab, Stephen S

    2006-05-01

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

  6. Modelling blood safety

    NARCIS (Netherlands)

    Janssen, M.P.

    2010-01-01

    This thesis describes the development and application of methods and models to support decision making on safety measures aimed at preventing the transmission of infections by blood donors. Safety measures refer to screening tests for blood donors, quarantine periods for blood plasma, or methods for

  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. Dynamic Safety Cases for Through-Life Safety Assurance

    Science.gov (United States)

    Denney, Ewen; Pai, Ganesh; Habli, Ibrahim

    2015-01-01

    We describe dynamic safety cases, a novel operationalization of the concept of through-life safety assurance, whose goal is to enable proactive safety management. Using an example from the aviation systems domain, we motivate our approach, its underlying principles, and a lifecycle. We then identify the key elements required to move towards a formalization of the associated framework.

  9. FURNAS activities in safety and quality assurance

    International Nuclear Information System (INIS)

    Dezordi, W.L.; Correa Filho, S.M.; Sacco, W.; Morais, L.H.G. de

    1980-01-01

    The aspects involved in the quality assurance performed by FURNAS for Nuclear Power Plant - Angra Unit I, are shown. Furnas' responsabilities in the licensing regarding reactor safety are also discussed. A summary of the computer codes used in the licensing process is given. (e.G.) [pt

  10. 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

  11. Role of quality assurance in reactor safety

    International Nuclear Information System (INIS)

    Roedel, J.A.

    1975-01-01

    A quality assurance program based on common sense, designed to accomplish what is reasonable and necessary, giving proper consideration to safety and economics can be an effective and essential management tool for the design, construction and operation of safe and economical nuclear power plants

  12. Software Quality Assurance for Nuclear Safety Systems

    International Nuclear Information System (INIS)

    Sparkman, D R; Lagdon, R

    2004-01-01

    The US Department of Energy has undertaken an initiative to improve the quality of software used to design and operate their nuclear facilities across the United States. One aspect of this initiative is to revise or create new directives and guides associated with quality practices for the safety software in its nuclear facilities. Safety software includes the safety structures, systems, and components software and firmware, support software and design and analysis software used to ensure the safety of the facility. DOE nuclear facilities are unique when compared to commercial nuclear or other industrial activities in terms of the types and quantities of hazards that must be controlled to protect workers, public and the environment. Because of these differences, DOE must develop an approach to software quality assurance that ensures appropriate risk mitigation by developing a framework of requirements that accomplishes the following goals: (sm b ullet) Ensures the software processes developed to address nuclear safety in design, operation, construction and maintenance of its facilities are safe (sm b ullet) Considers the larger system that uses the software and its impacts (sm b ullet) Ensures that the software failures do not create unsafe conditions Software designers for nuclear systems and processes must reduce risks in software applications by incorporating processes that recognize, detect, and mitigate software failure in safety related systems. It must also ensure that fail safe modes and component testing are incorporated into software design. For nuclear facilities, the consideration of risk is not necessarily sufficient to ensure safety. Systematic evaluation, independent verification and system safety analysis must be considered for software design, implementation, and operation. The software industry primarily uses risk analysis to determine the appropriate level of rigor applied to software practices. This risk-based approach distinguishes safety

  13. Positioning Food Safety in Halal Assurance

    OpenAIRE

    Demirci, M, N; Soon, Jan Mei; Wallace, Carol Anne

    2016-01-01

    Muslims follow the religion of Islam and the food they eat should be Halal, meaning lawful or permissible. Muslims are allowed to eat halal and wholesome food that has been provided for them. However, some of the main prohibitions are swine flesh, blood, carrion, animals not slaughtered according to Islamic laws and alcoholic drinks. At present Halal assurance is in a complicated state, with various Halal standards differing from each other without gaining mutual acceptance. The world is star...

  14. 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.

  15. International organisations assure nuclear safety competence

    International Nuclear Information System (INIS)

    Alonso, A.

    2000-01-01

    Irrespective of current views on the future of nuclear power programmes, concerns are arising with respect to the long-term ability to preserve safety competence because student enrollments in nuclear engineering are decreasing rapidly and experienced staff are reaching retirement age. 'Assuring Nuclear Safety Competence into the 21. Century' was discussed in depth by workshop participants. The need for a long-term strategic view was emphasised, and policy recommendations were made. These proceedings will be of particular interest to those playing a policy role in the nuclear industry, regulatory bodies and the education sector

  16. Quality assurance for software important to safety

    International Nuclear Information System (INIS)

    2000-01-01

    Software applications play an increasingly relevant role in nuclear power plant systems. This is particularly true of software important to safety used in both: calculations for the design, testing and analysis of nuclear reactor systems (design, engineering and analysis software); and monitoring, control and safety functions as an integral part of the reactor systems (monitoring, control and safety system software). Computer technology is advancing at a fast pace, offering new possibilities in nuclear reactor design, construction, commissioning, operation, maintenance and decommissioning. These advances also present new issues which must be considered both by the utility and by the regulatory organization. Refurbishment of ageing instrumentation and control systems in nuclear power plants and new safety related application areas have emerged, with direct (e.g. interfaces with safety systems) and indirect (e.g. operator intervention) implications for safety. Currently, there exist several international standards and guides on quality assurance for software important to safety. However, none of the existing documents provides comprehensive guidance to the developer, manager and regulator during all phases of the software life-cycle. The present publication was developed taking into account the large amount of available documentation, the rapid development of software systems and the need for updated guidance on h ow to do it . It provides information and guidance for defining and implementing quality assurance programmes covering the entire life-cycle of software important to safety. Expected users are managers, performers and assessors from nuclear utilities, regulatory bodies, suppliers and technical support organizations involved with the development and use of software applied in nuclear power plants

  17. Management services, quality assurance, and safety

    International Nuclear Information System (INIS)

    Anon.

    1987-01-01

    Broad technical and administrative support for the programmatic research and development activities of the Fusion Energy Division is provided by the Management Services Section and by the division's quality assurance (QA) and safety programs. Support is provided through effective communication with division programmatic staff and through the coordination of resources from disciplines outside the division. The QA activity in the division emphasizes the development and documentation of a QA program that conforms to national standards, the review and approval of engineering documents, supplier surveillance, identification and documentation of nonconforming items, audits, and QA assessments/plans. The division's safety activities include a formal safety program, emergency planning activities, and environmental protection services. Efforts devoted to the removal of hazardous wastes from division facilities were expanded during 1986

  18. IAEA code and safety guides on quality assurance

    International Nuclear Information System (INIS)

    Raisic, N.

    1980-01-01

    In the framework of its programme in safety standards development, the IAEA has recently published a Code of Practice on Quality Assurance for Safety in Nuclear Power Plants. The Code establishes minimum requirements for quality assurance which Member States should use in the context of their own nuclear safety requirements. A series of 10 Safety Guides which describe acceptable methods of implementing the requirements of specific sections of the Code are in preparation. (orig.)

  19. Evaluation of reliability assurance approaches to operational nuclear safety

    International Nuclear Information System (INIS)

    Mueller, C.J.; Bezella, W.A.

    1984-01-01

    This report discusses the results of research to evaluate existing and/or recommended safety/reliability assurance activities among nuclear and other high technology industries for potential nuclear industry implementation. Since the Three Mile Island (TMI) accident, there has been increased interest in the use of reliability programs (RP) to assure the performance of nuclear safety systems throughout the plant's lifetime. Recently, several Nuclear Regulatory Commission (NRC) task forces or safety issue review groups have recommended RPs for assuring the continuing safety of nuclear reactor plants. 18 references

  20. [Innovative technology and blood safety].

    Science.gov (United States)

    Begue, S; Morel, P; Djoudi, R

    2016-11-01

    If technological innovations are not enough alone to improve blood safety, their contributions for several decades in blood transfusion are major. The improvement of blood donation (new apheresis devices, RFID) or blood components (additive solutions, pathogen reduction technology, automated processing of platelets concentrates) or manufacturing process of these products (by automated processing of whole blood), all these steps where technological innovations were implemented, lead us to better traceability, more efficient processes, quality improvement of blood products and therefore increased blood safety for blood donors and patients. If we are on the threshold of a great change with the progress of pathogen reduction technology (for whole blood and red blood cells), we hope to see production of ex vivo red blood cells or platelets who are real and who open new conceptual paths on blood safety. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  1. Technology and Tool Development to Support Safety and Mission Assurance

    Science.gov (United States)

    Denney, Ewen; Pai, Ganesh

    2017-01-01

    The Assurance Case approach is being adopted in a number of safety-mission-critical application domains in the U.S., e.g., medical devices, defense aviation, automotive systems, and, lately, civil aviation. This paradigm refocuses traditional, process-based approaches to assurance on demonstrating explicitly stated assurance goals, emphasizing the use of structured rationale, and concrete product-based evidence as the means for providing justified confidence that systems and software are fit for purpose in safely achieving mission objectives. NASA has also been embracing assurance cases through the concepts of Risk Informed Safety Cases (RISCs), as documented in the NASA System Safety Handbook, and Objective Hierarchies (OHs) as put forth by the Agency's Office of Safety and Mission Assurance (OSMA). This talk will give an overview of the work being performed by the SGT team located at NASA Ames Research Center, in developing technologies and tools to engineer and apply assurance cases in customer projects pertaining to aviation safety. We elaborate how our Assurance Case Automation Toolset (AdvoCATE) has not only extended the state-of-the-art in assurance case research, but also demonstrated its practical utility. We have successfully developed safety assurance cases for a number of Unmanned Aircraft Systems (UAS) operations, which underwent, and passed, scrutiny both by the aviation regulator, i.e., the FAA, as well as the applicable NASA boards for airworthiness and flight safety, flight readiness, and mission readiness. We discuss our efforts in expanding AdvoCATE capabilities to support RISCs and OHs under a project recently funded by OSMA under its Software Assurance Research Program. Finally, we speculate on the applicability of our innovations beyond aviation safety to such endeavors as robotic, and human spaceflight.

  2. Quality assurance and nuclear power plant safety

    International Nuclear Information System (INIS)

    Mullan, J.V.

    1983-01-01

    Quality assurance in the nuclear industry was born in the late 1960s. Atomic Energy Control Board staff began its regulatory practice on quality assurance during that period. In this presentation the author traces the circumstances that first led to the establishment of Canadian nuclear power plant quality assurance programmes, summarizes progress over the last decade and a half, and outlines the current regulatory approach and what has been learned so far

  3. 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...

  4. Probabilistic studies for a safety assurance program

    International Nuclear Information System (INIS)

    Iyer, S.S.; Davis, J.F.

    1985-01-01

    The adequate supply of energy is always a matter of concern for any country. Nuclear power has played, and will continue to play an important role in supplying this energy. However, safety in nuclear power production is a fundamental prerequisite in fulfilling this role. This paper outlines a program to ensure safe operation of a nuclear power plant utilizing the Probabilistic Safety Studies

  5. 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.

  6. Quality assurance requirements for the computer software and safety analyses

    International Nuclear Information System (INIS)

    Husarecek, J.

    1992-01-01

    The requirements are given as placed on the development, procurement, maintenance, and application of software for the creation or processing of data during the design, construction, operation, repair, maintenance and safety-related upgrading of nuclear power plants. The verification and validation processes are highlighted, and the requirements put on the software documentation are outlined. The general quality assurance principles applied to safety analyses are characterized. (J.B.). 1 ref

  7. Nuclear and radiation safety assurance federal target programme management system

    International Nuclear Information System (INIS)

    Kryukov, O.V.; Vasil'ev, V.A.; Nikishin, D.A.; Linge, I.I.; Obodinskij, A.N.

    2012-01-01

    The Federal Program Nuclear and Radiation Safety Assurance for 2008-2015 is presented. Specifics of Federal target program management as well as changes to program management are discussed. Data on evaluation of management effectiveness is given. Further efforts to resolve the nuclear legacy problem in Russia are also presented [ru

  8. 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).

  9. Safety Assurance for Irradiating Experiments in the Advanced Test Reactor

    Energy Technology Data Exchange (ETDEWEB)

    T. A. Tomberlin; S. B. Grover

    2004-11-01

    The Advanced Test Reactor (ATR), located at the Idaho National Engineering and Environmental Laboratory (INEEL), was specifically designed to provide a high neutron flux test environment for conducting a variety of experiments. This paper addresses the safety assurance process for two general types of experiments conducted in the ATR facility and how the safety analyses for experiments are related to the ATR safety basis. One type of experiment is more routine and generally represents greater risks; therefore, this type of experiment is addressed in more detail in the ATR safety basis. This allows the individual safety analysis for this type of experiment to be more standardized. The second type of experiment is defined in more general terms in the ATR safety basis and is permitted under more general controls. Therefore, the individual safety analysis for the second type of experiment tends to be more unique and is tailored to each experiment.

  10. Safety Assurance for Irradiating Experiments in the Advanced Test Reactor

    International Nuclear Information System (INIS)

    T. A. Tomberlin; S. B. Grover

    2004-01-01

    The Advanced Test Reactor (ATR), located at the Idaho National Engineering and Environmental Laboratory (INEEL), was specifically designed to provide a high neutron flux test environment for conducting a variety of experiments. This paper addresses the safety assurance process for two general types of experiments conducted in the ATR facility and how the safety analyses for experiments are related to the ATR safety basis. One type of experiment is more routine and generally represents greater risks; therefore, this type of experiment is addressed in more detail in the ATR safety basis. This allows the individual safety analysis for this type of experiment to be more standardized. The second type of experiment is defined in more general terms in the ATR safety basis and is permitted under more general controls. Therefore, the individual safety analysis for the second type of experiment tends to be more unique and is tailored to each experiment

  11. 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

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

    OpenAIRE

    Kukla S.

    2016-01-01

    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 wor...

  13. Assuring nuclear safety competence into the 21. century

    International Nuclear Information System (INIS)

    2000-01-01

    Irrespective of current views on the future of nuclear power programmes, concerns are arising with respect to the long-term ability to preserve safety competence because student enrollments in nuclear engineering are decreasing rapidly and experienced staff are reaching retirement age. 'Assuring Nuclear Safety Competence into the 21. Century' was discussed in depth by workshop participants. The need for a long-term strategic view was emphasised, and policy recommendations were made. These proceedings will be of particular interest to those playing a policy role in the nuclear industry, regulatory bodies and the education sector. (author)

  14. Organizing safety: conditions for successful information assurance programs.

    Science.gov (United States)

    Collmann, Jeff; Coleman, Johnathan; Sostrom, Kristen; Wright, Willie

    2004-01-01

    Organizations must continuously seek safety. When considering computerized health information systems, "safety" includes protecting the integrity, confidentiality, and availability of information assets such as patient information, key components of the technical information system, and critical personnel. "High Reliability Theory" (HRT) argues that organizations with strong leadership support, continuous training, redundant safety mechanisms, and "cultures of high reliability" can deploy and safely manage complex, risky technologies such as nuclear weapons systems or computerized health information systems. In preparation for the Health Insurance Portability and Accountability Act (HIPAA) of 1996, the Office of the Assistant Secretary of Defense (Health Affairs), the Offices of the Surgeons General of the United States Army, Navy and Air Force, and the Telemedicine and Advanced Technology Research Center (TATRC), US Army Medical Research and Materiel Command sponsored organizational, doctrinal, and technical projects that individually and collectively promote conditions for a "culture of information assurance." These efforts include sponsoring the "P3 Working Group" (P3WG), an interdisciplinary, tri-service taskforce that reviewed all relevant Department of Defense (DoD), Miliary Health System (MHS), Army, Navy and Air Force policies for compliance with the HIPAA medical privacy and data security regulations; supporting development, training, and deployment of OCTAVE(sm), a self-directed information security risk assessment process; and sponsoring development of the Risk Information Management Resource (RIMR), a Web-enabled enterprise portal about health information assurance.

  15. 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.

  16. Assuring fish safety and quality in international fish trade

    International Nuclear Information System (INIS)

    Ababouch, Lahsen . E-mail lahsen.ababouch@fao.org

    2006-01-01

    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

  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. Guidance for implementing an environmental, safety, and health-assurance program. Volume 15. A model plan for line organization environmental, safety, and health-assurance programs

    Energy Technology Data Exchange (ETDEWEB)

    Ellingson, A.C.; Trauth, C.A. Jr.

    1982-01-01

    This is 1 of 15 documents designed to illustrate how an Environmental, Safety and Health (ES and H) Assurance Program may be implemented. The generic definition of ES and H Assurance Programs is given in a companion document entitled An Environmental, Safety and Health Assurance Program Standard. This particular document presents a model operational-level ES and H Assurance Program that may be used as a guide by an operational-level organization in developing its own plan. The model presented here reflects the guidance given in the total series of 15 documents.

  19. 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.

  20. Integrating Safety and Mission Assurance into Systems Engineering Modeling Practices

    Science.gov (United States)

    Beckman, Sean; Darpel, Scott

    2015-01-01

    During the early development of products, flight, or experimental hardware, emphasis is often given to the identification of technical requirements, utilizing such tools as use case and activity diagrams. Designers and project teams focus on understanding physical and performance demands and challenges. It is typically only later, during the evaluation of preliminary designs that a first pass, if performed, is made to determine the process, safety, and mission quality assurance requirements. Evaluation early in the life cycle, though, can yield requirements that force a fundamental change in design. This paper discusses an alternate paradigm for using the concepts of use case or activity diagrams to identify safety hazard and mission quality assurance risks and concerns using the same systems engineering modeling tools being used to identify technical requirements. It contains two examples of how this process might be used in the development of a space flight experiment, and the design of a Human Powered Pizza Delivery Vehicle, along with the potential benefits to decrease development time, and provide stronger budget estimates.

  1. Software quality assurance plans for safety-critical software

    International Nuclear Information System (INIS)

    Liddle, P.

    2006-01-01

    Application software is defined as safety-critical if a fault in the software could prevent the system components from performing their nuclear-safety functions. Therefore, for nuclear-safety systems, the AREVA TELEPERM R XS (TXS) system is classified 1E, as defined in the Inst. of Electrical and Electronics Engineers (IEEE) Std 603-1998. The application software is classified as Software Integrity Level (SIL)-4, as defined in IEEE Std 7-4.3.2-2003. The AREVA NP Inc. Software Program Manual (SPM) describes the measures taken to ensure that the TELEPERM XS application software attains a level of quality commensurate with its importance to safety. The manual also describes how TELEPERM XS correctly performs the required safety functions and conforms to established technical and documentation requirements, conventions, rules, and standards. The program manual covers the requirements definition, detailed design, integration, and test phases for the TELEPERM XS application software, and supporting software created by AREVA NP Inc. The SPM is required for all safety-related TELEPERM XS system applications. The program comprises several basic plans and practices: 1. A Software Quality-Assurance Plan (SQAP) that describes the processes necessary to ensure that the software attains a level of quality commensurate with its importance to safety function. 2. A Software Safety Plan (SSP) that identifies the process to reasonably ensure that safety-critical software performs as intended during all abnormal conditions and events, and does not introduce any new hazards that could jeopardize the health and safety of the public. 3. A Software Verification and Validation (V and V) Plan that describes the method of ensuring the software is in accordance with the requirements. 4. A Software Configuration Management Plan (SCMP) that describes the method of maintaining the software in an identifiable state at all times. 5. A Software Operations and Maintenance Plan (SO and MP) that

  2. 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.

  3. Assuring future competence in nuclear safety in Finland

    International Nuclear Information System (INIS)

    Koskinen, K.

    2004-01-01

    Full text: Background: Within last few years we have been faced the fact that ageing of experts in nuclear safety field cannot be ignored in Finland. A great number of all experts/specialists with special competence on nuclear safety studied in the early 70's and had their first permanent jobs in the 'golden era' of nuclear power. These experts are going to retire within next ten years. Therefore both the regulatory body and licensees in Finland have the situation where the age distribution of staff member has become distorted. Also the amount of students in universities which have nuclear technology as their major subject has diminished remarkably until the decision of the new nuclear power plant unit in Finland was made in May 2001. After that the amount of students has risen. Assuring competences within the regulatory body STUK adopted the systematic approach to training in early 90's, this method is widely presented in IAEA TECDOC 1254 (2001). However, the very low turnover of staff led to decrease of training needs and therefore also the systematic training efforts decreased. In 2001 a need to restart the systematic approach to assuring competences was identified. To improve competence management at the regulatory body a competence analysis was carried out and a human resource plan for nuclear safety area for the near future was made. Competence analysis is a method which is quite commonly used on public sector and governmental organisations in Finland. STUK studied carefully the models used in other public sector organisations and adjusted the method to its own purposes. The model used has four competence categories: substance related, management skills, common working skills and STUK related working skills. Substance related competences were defined and described at working unit level. Descriptions for the rest three categories were made at STUK level and those were common for all departments. Substance related competencies common to all working at the

  4. 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.

  5. Safety assurance for nuclear chemical plants - regulatory practice in the UK

    International Nuclear Information System (INIS)

    Driscoll, J.; Charlesworth, F.

    1983-01-01

    This paper describes the legislation and licensing requirements for nuclear installations as well as the related safety assurance procedures in the UK. Developments in safety assurance practice are identified and discussed in relation to the role of the regulator and of the operator. (NEA) [fr

  6. Quality assurance and radiation safety in positron emission tomography

    International Nuclear Information System (INIS)

    Kmetyuk, Ya.V.; Radosh, H.V.; Bezshyyko, O.A.; Golinka-Bezshyyko, L.O.; Kadenko, I.M.; Kazinova, O.A.; Nagai, A.O.

    2012-01-01

    Scientific studies, clinical experience and economic analysis have shown that the positron emission tomography (PET) is clinically and cost effective cancer diagnostics method. Combined PET and computed tomography (PET/CT) has proven clinical utility, particularly in the diagnosis, staging or restaging malignant disease and metastases, surgical planning, radiation therapy planning and evaluation of treatment response. The use of PET/CT has grown substantially in the past few years, with an increasing number of hospitals and installations of PET/CT imaging centers each year. In the same time combination of 2 procedures, each of which impart a radiation dose and, as a result, increases the deleterious influence for health, creates additional radiation safety issues. In these conditions the role of quality assurance (QA) and quality control (QC) programs is getting more and more important. We considered main QA and radiation safety requirements for whole PET technology chain from radio-pharmacy facilities to PET/CT scanning and patient release criteria. All these issues were considered and assessed having the example of PET facilities and technology chain of All-Ukrainian Center for Radiosurgery of the Clinical Hospital 'Feofania'

  7. 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

  8. The assurance as a result of blood chemical analysis by ISO-GUM and QE

    Energy Technology Data Exchange (ETDEWEB)

    Iwaki, Y., E-mail: yasuo.iwaki@nifty.ne.j

    2010-07-01

    calculated from the Effective Free Degree (EFD) which thought the number of samples is important. Free degree is based on maximum likelihood method of an improved information criterion (AIC) for a Quality Control (QC). The assurance performance of ISO-GUM is come out by set up of the confidence interval [3] and is decided. The result of research of 'Decided level/Minimum Detectable Concentration (DL/MDC)' was able to profit by the operation. QE has developed for the QC of industry. However, these have been processed by regression analysis by making frequency probability of a statistic value into normalized distribution. The occurrence probability of the statistics value of a fault element which is accompanied element by a natural phenomenon becomes an abnormal distribution in many cases. The abnormal distribution needs to obtain an assurance value by other method than statistical work of type B in ISO-GUM. It is tried fusion the improvement of worker by QE became important for reservation of the reliability of measurement accuracy and safety. This research was to make the result of Blood Chemical Analysis (BCA) in the field of clinical test. (imeko tc1-tc7 symposium in london)

  9. Assuring safety without animal testing: Unilever's ongoing research programme to deliver novel ways to assure consumer safety.

    Science.gov (United States)

    Westmoreland, Carl; Carmichael, Paul; Dent, Matt; Fentem, Julia; MacKay, Cameron; Maxwell, Gavin; Pease, Camilla; Reynolds, Fiona

    2010-01-01

    Assuring consumer safety without the generation of new animal data is currently a considerable challenge. However, through the application of new technologies and the further development of risk-based approaches for safety assessment, we remain confident it is ultimately achievable. For many complex, multi-organ consumer safety endpoints, the development, evaluation and application of new, non-animal approaches is hampered by a lack of biological understanding of the underlying mechanistic processes involved. The enormity of this scientific challenge should not be underestimated. To tackle this challenge a substantial research programme was initiated by Unilever in 2004 to critically evaluate the feasibility of a new conceptual approach based upon the following key components: 1.Developing new, exposure-driven risk assessment approaches. 2.Developing new biological (in vitro) and computer-based (in silico) predictive models. 3.Evaluating the applicability of new technologies for generating data (e.g. "omics", informatics) and for integrating new types of data (e.g. systems approaches) for risk-based safety assessment. Our research efforts are focussed in the priority areas of skin allergy, cancer and general toxicity (including inhaled toxicity). In all of these areas, a long-term investment is essential to increase the scientific understanding of the underlying biology and molecular mechanisms that we believe will ultimately form a sound basis for novel risk assessment approaches. Our research programme in these priority areas consists of in-house research as well as Unilever-sponsored academic research, involvement in EU-funded projects (e.g. Sens-it-iv, Carcinogenomics), participation in cross-industry collaborative research (e.g. Colipa, EPAA) and ongoing involvement with other scientific initiatives on non-animal approaches to risk assessment (e.g. UK NC3Rs, US "Human Toxicology Project" consortium).

  10. 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.

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

    Science.gov (United States)

    2010-07-01

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

  12. 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.

  13. 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.

  14. New Paradigm in Nuclear Safety from Quality Assurance to Safety Management System

    International Nuclear Information System (INIS)

    Lim, Nam-Jin; Park, Chan-Gook; Nam, Ji-Hee; Kim, Kwan-Hyun; Kwon, Hyuk-il; Lee, Young-Gun Lee

    2006-01-01

    The initial concept of Quality Control (QC) controlling the quality of products is now evolving toward the Management System (MS) achieving safety, through Quality Assurance (QA) ensuring the quality of products and Quality Management (QM) managing the quality by a systematic approach. Nuclear safety can be achieved through an integrated MS that ensures the health, environmental, security, quality and economic requirements being considered together with nuclear safety requirements. MS approach is developed through realizing that most of nuclear accidents had occurred not by the malfunction of hardware or equipment, but by the human error. The MS is a set of inter-related or interacting elements (system) that establishes policies and objectives and which enables those objectives to be achieved in an efficient and effective way

  15. The Role Of Quality Assurance Program For Safety Operation Of Nuclear Installations

    International Nuclear Information System (INIS)

    Harjanto, N.T.; Purwadi, K.P.; Boru, D.S.; Farida; Suharni

    2000-01-01

    Nuclear installations expose potential hazard of radiation, therefore in their construction, operation and maintenance, it is necessary to consider safety aspect, in which the safety requirements which has been determined must be met. One of the requirements that is absolutely needed is quality assurance, which covers arrangement of quality assurance program, organization and administration of the implementation of quality assurance, and supervision. Quality Assurance program is a guideline containing quality policies and basic determination on the realization of activities that effect the quality of equipment's and items used in the operation of nuclear installations in order that the operation of nuclear installation can run safety and in accordance with their design aims and operation limits. Quality Assurance Program includes document control, design control, supply control, control of equipment s and items, operation/process control, inspection and control of equipment test, and control of nonconformance and corrections. General system of nuclear installation operation is equipped with safety and supporting systems. These systems must apply the quality assurance program that cover control of activities in the systems. In the implementation of the quality assurance program, it is necessary to establish procedures, work guidelines/instructions, and quality recording that constitutes documents of quality system 2 nd , 3 th , and 4 th level after the quality assurance program. To ensure the effectivity and to prove whether the realization of the program has been pursuant to the determined requirements, an internal audit must be conducted accordingly

  16. Quality assurance for safety in the radioactive waste management: a quality assurance system in Novi Han radioactive waste repository

    International Nuclear Information System (INIS)

    Petrova, A.; Kolev, I.

    2000-01-01

    Novi Han Radioactive Waste Repository (RWR) is still the only place in Bulgaria for storage of low and intermediate level radioactive waste. It is necessary to establish and maintain a Quality Assurance (QA) system to ensure that the RWR can be operated safely with regard to the health and safety of the general public and site personnel. A QA system has to establish the basic requirements for quality assurance in order to enhance nuclear safety by continuously improving the methods employed to achieve quality. It is envisaged that the QA system for the Novi Han RWR will cover the operation and maintenance of the radioactive waste disposal facilities, the radiation protection and monitoring of the site, as well as the scientific and technology development aspects. The functions of the Novi Han RWR presume the availability of an environmental management system. It is appropriate to establish a QA system based on the requirements of the ISO Standards 9001 and 14000, using the recommendations of the IAEA (Quality assurance for safety in NPPs and other nuclear installations, code and safety guides Q1-Q14). (authors)

  17. Blood safety in the world updated

    Institute of Scientific and Technical Information of China (English)

    Silvano Wandel

    2010-01-01

    @@ Blood safety is of paramount importance in any medical context, given that it represents one of the most impor-tant supportive procedures in medicine. Nearly all medical fields that lead with very critical patients will depend on blood products as part of supporting medical strategies (both clinical and surgical). Thus, it is im-portant that every country in the world relies on a well established national blood program.

  18. Role of Informatics in Patient Safety and Quality Assurance.

    Science.gov (United States)

    Nakhleh, Raouf E

    2015-06-01

    Quality assurance encompasses monitoring daily processes for accurate, timely, and complete reports in surgical pathology. Quality assurance also includes implementation of policies and procedures that prevent or detect errors in a timely manner. This article presents uses of informatics in quality assurance. Three main foci are critical to the general improvement of diagnostic surgical pathology. First is the application of informatics to specimen identification with lean methods for real-time statistical control of specimen receipt and processing. Second is the development of case reviews before sign-out. Third is the development of information technology in communication of results to assure treatment in a timely manner. Copyright © 2015 Elsevier Inc. All rights reserved.

  19. DAAS: Data Analytics for Assurance of Safety, Phase I

    Data.gov (United States)

    National Aeronautics and Space Administration — Assuring safe operations in the National Airspace (NAS) encompasses monitoring a variety of systems simultaneously and in real time. It is helpful to imagine NAS as...

  20. Philosophy of safety assurance after the Fukushima Daiichi accident. From views of experts

    International Nuclear Information System (INIS)

    Hisada, Tsukasa

    2014-01-01

    Knowledge incorporating meetings were held to exchange views of experts in order to learn respective safety concept and philosophy of safety assurance except nuclear area, how should be prepared for beyond expectation and what was needed to build social credibility, and how to upgrade safety measures of nuclear power station after the Fukushima Daiichi accident. Meeting had been held twice a year since FY2012 and two lecturers were invited at each meeting to give a lecture on the specified theme such as safety assurance in aviation area and chemical plants, and 'safety target of engineering system'. Common or different views on safety assurance between nuclear and other areas were identified, and risk concept and sincere attitude of explaining engineer were mentioned quite important for preparation for beyond expectation and building social credibility. (T. Tanaka)

  1. Code of practice on quality assurance for safety in nuclear power plants

    International Nuclear Information System (INIS)

    1988-01-01

    The code sets forth the management principles and objectives to be met during the implementation of activities in different phases of the nuclear power plants (NPPs) for assuring safety. It is intended for use by organisations and individuals responsible for safety related functions in design, manufacturing, construction, commissioning, operation and decommissioning of NPPs. It covers the functions of management, performance, verification and corrective action. It also deals with the quality assurance records. (M.G.B.)

  2. Software quality assurance for safety analysis and risk management at the Savannah River Site

    International Nuclear Information System (INIS)

    Ades, M.J.; Toffer, H.; Crowe, R.D.

    1991-01-01

    As part of its Reactor Operations Improvement Program at the Savannah River Site (SRS), Westinghouse Savannah River Company (WSRC), in cooperation with the Westinghouse Hanford Company, has developed and implemented quality assurance for safety-related software for technical programs essential to the safety and reliability of reactor operations. More specifically, the quality assurance process involved the development and implementation of quality standards and attendant procedures based on industry software quality standards. These procedures were then applied to computer codes in reactor safety and probabilistic risk assessment analyses. This paper provides a review of the major aspects of the WSRC safety-related software quality assurance. In particular, quality assurance procedures are described for the different life cycle phases of the software that include the Requirements, Software Design and Implementation, Testing and Installation, Operation and Maintenance, and Retirement Phases. For each phase, specific provisions are made to categorize the range of activities, the level of responsibilities, and the documentation needed to assure the control of the software. The software quality assurance procedures developed and implemented are evolutionary in nature, and thus, prone to further refinements. These procedures, nevertheless, represent an effective controlling tool for the development, production, and operation of safety-related software applicable to reactor safety and probabilistic risk assessment analyses

  3. Code on the safety of nuclear power plants: Quality assurance

    International Nuclear Information System (INIS)

    1988-01-01

    This revised Code provides the principles and objectives for the establishment and implementation of quality assurance programmes applied to both the overall and each of the constituent activities associated with a nuclear power plant project. The quality assurance principles enumerated in the present Code can be usefully applied to nuclear facilities other than nuclear power plants. The quality assurance programme encompasses: (1) the activities that are necessary to achieve the appropriate quality of the respective item or service; and (2) the activities that are necessary for verifying that the required quality is achieved and that objective evidence is produced to that effect. Quality assurance is an essential aspect of good management and the quality assurance programme is the main management tool for a disciplined approach to all activities affecting quality, including, where appropriate, verification that each task has been satisfactorily performed and that necessary corrective actions have been implemented. The principles and objectives provided by the Code are applicable by all those responsible for the nuclear power plant, by plant designers, suppliers, architect-engineers, plant constructors, plant operators and other organizations participating in activities affecting quality. The Code is a revision of the previous Code of Practice (1978) on the same subject of interest to regulatory bodies and experts in quality assurance for design, siting and operation of nuclear power plants. Contents: Definitions; 1. Introduction; 2. Quality assurance programmes; 3. Organization; 4. Document control; 5. Design control; 6. Procurement control; 7. Control of items; 8. Process control; 9. Inspection and test control; 10. Non-conformance control; 11. Corrective actions; 12, Records; 13. Audits

  4. Application of quality assurance program to safety related aging equipment or components

    International Nuclear Information System (INIS)

    Papaiya, N.C.

    1990-01-01

    This paper addresses how quality assurance programs and their criteria are applied to safety related and aging equipment or components used in commercial nuclear plant applications. The QA Programs referred to are 10CFR50 Appendix B and EPRI NP-5652. The QA programs as applicable are applied to equipment/component aging qualification, preventive maintenance, surveillance testing and procurement engineering. The intent of this paper is not the technical issues, methods and research of aging. The paper addresses QA program's application to age-related equipment or components in safety related applications. Quality Assurance Program 10CFR50 Appendix B applies to all safety related aging components or equipment related to the qualification program and associated preventive maintenance and surveillance testing programs. Quality Assurance involvement with procurement engineering for age-related commercial grade items supports EPRI NP-5652 and assures that the dedicated OGI is equal to the item purchased as a basic component to 10CFR50 Appendix B requirements

  5. Manual on quality assurance for computer software related to the safety of nuclear power plants

    International Nuclear Information System (INIS)

    1988-01-01

    The objective of the Manual is to provide guidance in the assurance of quality of specification, design, maintenance and use of computer software related to items and activities important to safety (hereinafter referred to as safety related) in nuclear power plants. This guidance is consistent with, and supplements, the requirements and recommendations of Quality Assurance for Safety in Nuclear Power Plants: A Code of Practice, 50-C-QA, and related Safety Guides on quality assurance for nuclear power plants. Annex A identifies the IAEA documents referenced in the Manual. The Manual is intended to be of use to all those who, in any way, are involved with software for safety related applications for nuclear power plants, including auditors who may be called upon to audit management systems and product software. Figs

  6. Development of a quality assurance safety assessment database for near surface radioactive waste disposal

    International Nuclear Information System (INIS)

    Park, J. W.; Kim, C. L.; Park, J. B.; Lee, E. Y.; Lee, Y. M.; Kang, C. H.; Zhou, W.; Kozak, M. W.

    2003-01-01

    A quality assurance safety assessment database, called QUARK (QUality Assurance program for Radioactive waste management in Korea), has been developed to manage both analysis information and parameter database for safety assessment of Low- and Intermediate-Level radioactive Waste (LILW) disposal facility in Korea. QUARK is such a tool that serves QA purposes for managing safety assessment information properly and securely. In QUARK, the information is organized and linked to maximize the integrity of information and traceability. QUARK provides guidance to conduct safety assessment analysis, from scenario generation to result analysis, and provides a window to inspect and trace previous safety assessment analysis and parameter values. QUARK also provides default database for safety assessment staff who construct input data files using SAGE(Safety Assessment Groundwater Evaluation), a safety assessment computer code

  7. Call for NDT leadership role in assuring safety of nuclear power

    International Nuclear Information System (INIS)

    Anders, W.A.; Simpson, J.W.

    1976-01-01

    Nondestructive Testing and its potential role in assuring the safety of nuclear power were given emphasis at a conference on Nondestructive Testing in the Nuclear Industry sponsored by the American Society for Metals Dec. 1--3 in Denver, Colo. Excerpts from two major addresses challenging the NDT community to assume leadership in solving nuclear safety problems are presented

  8. Safety assurance logic techniques for evaluation of accident prevention and mitigation

    International Nuclear Information System (INIS)

    McWethy, L.M.; Hagan, J.W.

    1976-01-01

    Safety assurance methods have been developed and applied in reactor safety assessments of FFTF. These methods promote visibility of the total safety provided by the plant, both in prevention of off-normal or accident conditions as well as provision of various features which terminate conditions within acceptable bounds if such conditions should occur. One of the primary techniques applied in safety assurance is the development of safety assurance diagrams. These diagrams explicitly identify the multiple lines of defense which prevent accident progression. The diagrams graphically demonstrate the defense-in-depth provided by the plant for each postulated occurrence. Lines of defense are shown against ever having an occurrence in the first place; thus giving appropriate emphasis on accident prevention, and visibility to the designer's role in promoting this level of safety. These diagrams, or accident process trees, also show graphically the various paths of postulated accident progression to their logical termination. Evaluation of the importance and strength of each line-of-defense assures fulfillment of the safety objectives of the overall plant system

  9. A complex tool and three simple approaches to improving quality assurance and safety in external radiotherapy

    International Nuclear Information System (INIS)

    Salinas, F; Sansogne, R; Arbiser, S; Suarez, V; Franco, M; Escobar, J

    2012-01-01

    Quality assurance and safety controls in radiation therapy delivery processes that involve the Physics Department of an institution are commonly time consuming tasks. Carrying out daily controls in very busy clinics without compromising patient schedule is challenging. This work describes the usage of Electronic Portal Imaging Devices in combination with some in-house software to simplify and systematize three different tasks of the Physics Department Quality Assurance Program, improving the easiness, reliability and velocity of daily tests (author)

  10. Roles of the operator and the safety services in nuclear power plant quality assurance

    International Nuclear Information System (INIS)

    Widmer, M.; Perrot, J.

    1985-01-01

    With regard to the operation of nuclear power plants, Electricite de France formally recognized in 1973 that it was necessary for safety reasons and economically acceptable to adopt organizational principles of quality assurance that would be applicable both to its own activities and to those of its suppliers. Generally speaking, the form and spirit of the quality assurance programme chosen is based largely on the Code of Practice No. 50-C-QA. In particular, the programme focuses on the flexible character of quality assurance requirements and stresses that in the final analysis product quality depends above all on those to whom the project has been assigned, because it is they who are responsible for meeting the quality objectives set. Ten years of experience with the suppliers of Electricite de France has shown that these suppliers, after some initial difficulty, have been able to adapt the application of quality assurance so as to achieve satisfactory quality as regards both safety and availability. In the case of the French standard nuclear power plants, quality assurance is particularly important thanks to the traceability which it affords and to the allowance for corrective measures which it demands. The safety services normally take action related to quality assurance in three ways: through regulation, the analysis of measures to assure plant safety, and plant supervision. As regards regulation, an order has just been published relating to design, construction and operational quality in base-load nuclear power plants. The requirements laid down in this document incorporate the recommendations of the IAEA Code on quality assurance. (author)

  11. Report on probabilistic safety assessment (PSA) quality assurance in utilization of risk information

    International Nuclear Information System (INIS)

    2006-12-01

    Recently in Japan, introduction of nuclear safety regulations using risk information such as probabilistic safety assessment (PSA) has been considered and utilization of risk information in the rational and practical measures on safety assurance has made a progress to start with the operation or inspection area. The report compiled results of investigation and studies of PSA quality assurance in risk-informed activities in the USA. Relevant regulatory guide and standard review plan as well as issues and recommendations were reviewed for technical adequacy and advancement of probabilistic risk assessment technology in risk-informed decision making. Useful and important information to be referred as issues in PSA quality assurance was identified. (T. Tanaka)

  12. 78 FR 54510 - New Entrant Safety Assurance Program Operational Test

    Science.gov (United States)

    2013-09-04

    ... safety management controls; (2) consider their effects on small businesses; and (3) consider establishing alternate locations where such reviews may be conducted for the convenience of small businesses. In response... safety review within 18 months of starting interstate operations. [49 U.S.C. 31144(g)]. In issuing these...

  13. Quality assurance and human error effects on the structural safety

    International Nuclear Information System (INIS)

    Bertero, R.; Lopez, R.; Sarrate, M.

    1991-01-01

    Statistical surveys show that the frequency of failure of structures is much larger than that expected by the codes. Evidence exists that human errors (especially during the design process) is the main cause for the difference between the failure probability admitted by codes and the reality. In this paper, the attenuation of human error effects using tools of quality assurance is analyzed. In particular, the importance of the independent design review is highlighted, and different approaches are discussed. The experience from the Atucha II project, as well as the USA and German practice on independent design review, are summarized. (Author)

  14. A proposed approach for enhancing design safety assurance of future plants

    International Nuclear Information System (INIS)

    Oh, Kyu Myeng; Ahn, Sang Kyu; Lee, Chang Ju; Kim, Inn Seock

    2010-01-01

    This paper provides various insights from a detailed review of deterministic approaches typically applied to ensure design safety of nuclear power plants (NPPs) and risk-informed approaches proposed to evaluate safety of advanced reactors such as Generation IV reactors. Also considered herein are the risk-informed safety analysis (RISA) methodology suggested by Westinghouse as a means to improve the conventional accident analysis, together with the Technology Neutral Framework recently suggested by the U.S. NRC for safety evaluation of future plants. These insights from the comparative review of deterministic and risk-informed approaches could be used in further enhancing the methodology for design safety assurance of future plants

  15. Reactor safety through quality assurance and in-service inspection

    International Nuclear Information System (INIS)

    Bush, S.H.

    The quality assurance is discussed of nuclear power plant equipment with respect to the following regulations: section 50 10 CFR - supplement B, section NA-400, ASME - section III and ANSI N-54.2. Quality assurance and reliability are assessed with regard to two aspects: all preoperational functions and all operating stages of the power plant. During the production of nuclear power plant components, increased attention should be devoted to the choice of material, materials testing, production programme and to the production process. During power plant operation, care should be given to periodical in-service inspections which guarantee the plant reliability; defects should immediately be remedied or the power plant shut down. Emphasis is put on the tests of reactor welded joints in compliance with the ASME code. The results of operating tests are used as feedback in the design and testing of the components during production. The probabilities were calculated of the occurrence and elimination of defects during the manufacture and operation of a nuclear reactor. (J.B.)

  16. Management of National Nuclear Power Programs for assured safety

    International Nuclear Information System (INIS)

    Connolly, T.J.

    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)

  17. 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).

  18. Guide for reviewing safety analysis reports for packaging: Review of quality assurance requirements

    International Nuclear Information System (INIS)

    Moon, D.W.

    1988-10-01

    This review section describes quality assurance requirements applying to design, purchase, fabrication, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair, and modification of components of packaging which are important to safety. The design effort, operation's plans, and quality assurance requirements should be integrated to achieve a system in which the independent QA program is not overly stringent and the application of QA requirements is commensurate with safety significance. The reviewer must verify that the applicant's QA section in the SARP contains package-specific QA information required by DOE Orders and federal regulations that demonstrate compliance. 8 refs

  19. 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.

  20. Metamodel comparison and model comparison for safety assurance

    NARCIS (Netherlands)

    Luo, Y.; Engelen, L.J.P.; Brand, van den M.G.J.; Bondavelli, A.; Ceccarelli, A.; Ortmeier, F.

    2014-01-01

    In safety-critical domains, conceptual models are created in the form of metamodels using different concepts from possibly overlapping domains. Comparison between those conceptual models can facilitate the reuse of models from one domain to another. This paper describes the mappings detected when

  1. Technical Excellence and Communication: The Cornerstones for Successful Safety and Mission Assurance Programs

    Science.gov (United States)

    Malone, Roy W.; Livingston, John M.

    2010-01-01

    The paper describes the role of technical excellence and communication in the development and maintenance of safety and mission assurance programs. The Marshall Space Flight Center (MSFC) Safety and Mission Assurance (S&MA) organization is used to illustrate philosophies and techniques that strengthen safety and mission assurance efforts and that contribute to healthy and effective organizational cultures. The events and conditions leading to the development of the MSFC S&MA organization are reviewed. Historic issues and concerns are identified. The adverse effects of resource limitations and risk assessment roles are discussed. The structure and functions of the core safety, reliability, and quality assurance functions are presented. The current organization s mission and vision commitments serve as the starting points for the description of the current organization. The goals and objectives are presented that address the criticisms of the predecessor organizations. Additional improvements are presented that address the development of technical excellence and the steps taken to improve communication within the Center, with program customers, and with other Agency S&MA organizations.

  2. Technical Excellence and Communication, the Cornerstones for Successful Safety and Mission Assurance Programs

    Science.gov (United States)

    Malone, Roy W.; Livingston, John M.

    2010-09-01

    The paper describes the role of technical excellence and communication in the development and maintenance of safety and mission assurance programs. The Marshall Space Flight Center(MSFC) Safety and Mission Assurance(S&MA) organization is used to illustrate philosophies and techniques that strengthen safety and mission assurance efforts and that contribute to healthy and effective organizational cultures. The events and conditions leading to the development of the MSFC S&MA organization are reviewed. Historic issues and concerns are identified. The adverse effects of resource limitations and risk assessment roles are discussed. The structure and functions of the core safety, reliability, and quality assurance functions are presented. The current organization’s mission and vision commitments serve as the starting points for the description of the current organization. The goals and objectives are presented that address the criticisms of the predecessor organizations. Additional improvements are presented that address the development of technical excellence and the steps taken to improve communication within the Center, with program customers, and with other Agency S&MA organizations.

  3. Quality assurance program plan for 324 Building B-Cell safety cleanout project (BCCP)

    International Nuclear Information System (INIS)

    Tanke, J.M.

    1997-01-01

    This Quality Assurance Program Plan (QAPP) provides information on how the Quality Assurance Program is implemented for the 324 Building B-Cell Safety Cleanout Project (BCCP). This QAPP is responsive to the Westinghouse Hanford Company Quality Assurance Program and Implementation Plan, WHC-SP-1131, for 10 CFR 830.120, Nuclear Safety Management, Quality Assurance Requirements; and DOE Order 5700.6C, Quality Assurance. This QAPP supersedes PNNL PNL-MA-70 QAP Quality Assurance Plan No. WTC-050 Rev. 2, issue date May 3, 1996. This QAPP has been developed specifically for the BCCP. It applies to those items and tasks which affect the completion of activities identified in the work breakdown structure of the Project Management Plan (PMP). These activities include all aspects of decontaminating B-Cell and project related operations within the 324 Building as it relates to the specific activities of this project. General facility activities (i.e. 324 Building Operations) are covered in the Building 324 QAPP. In addition, this QAPP supports the related quality assurance activities addressed in CM-2-14, Hazardous Material Packaging and Shipping, and HSRCM-1, Hanford Site Radiological Control Manual, The 324 Building is currently transitioning from being a Pacific Northwest National Laboratory (PNNL) managed facility to a B and W Hanford Company (BWHC) managed facility. During this transition process existing, PNNL procedures and documents will be utilized until replaced by BWHC procedures and documents. These documents conform to the requirements found in PNL-MA-70, Quality Assurance Manual and PNL-MA-8 1, Hazardous Materials Shipping Manual. The Quality Assurance Program Index (QAPI) contained in Table 1 provides a matrix which shows how project activities relate to 10 CFR 83 0.120 and 5700.6C criteria. Quality Assurance program requirements will be addressed separate from the requirements specified in this document. Other Hanford Site organizations/companies may be

  4. The contribution of quality assurance to safety and reliability in nuclear power plants

    International Nuclear Information System (INIS)

    Raisic, N.

    1978-01-01

    The potential contribution of quality assurance to nuclear power plant safety and reliability is analysed. An attempt is made to establish a relationship between quality and reliability. The reliability may be expressed in quantitative terms as ''the probability that an item will perform a required function for a stated period of time''. Quality, however, cannot be expressed in simple quantitative terms but only as a set of required properties which an item should have for a specific application. The achievement of quality and additional reliability objectives is a task of project activities such as design, construction, installation, operation, etc. The elements of a quality assurance system and its functions in nuclear power projects are presented in some detail. Confidence in plant quality, which should be a basis for the regulatory body issuing the construction permit or operation licence, should be based on the capability of quality assurance activities to prevent errors and correct deficiencies in nuclear power plants. An analysis is made of those errors in plant design, manufacture, construction and operation which contribute most frequently to plant outages. It is concluded that these errors can be avoided or corrected by strict adherence to quality assurance principles and by the efficient functioning of quality assurance systems. In fact, quality assurance may be considered an effective defence against common cause failures originating in errors in the design, manufacture, installation or operation of a nuclear power plant

  5. Knowledge management for assuring high standards in nuclear safety

    International Nuclear Information System (INIS)

    Hahn, L.

    2004-01-01

    The primary incentives for introducing knowledge management in organisations active in the nuclear field are the impending loss of knowledge due to an ageing workforce and the necessity to transfer knowledge to the next generation. However, knowledge management may reach much further, and it is shown that ultimately, the goals of knowledge management are congruent with establishing, maintaining and further developing high standards of safety. Knowledge-based activities to reach these goals are discussed, and examples given for producing, utilising and sharing knowledge in organisations and in national and international networks. (author)

  6. Quality assurance of the modernized Dukovany I and C safety system software

    International Nuclear Information System (INIS)

    Karpeta, C.

    2005-01-01

    The approach to quality assurance of the software that implements the instrumentation and control functions for safety category A as per IEC 61226, which has been adopted within the 'NPP Dukovany I and C Refurbishment' project, is described. A survey of the requirements for software quality assurance of the systems that initiate protection interventions in the event of anticipated operational occurrences or accident conditions is given. The software development process applied by the system designers and manufacturers, from the software requirements specification phase to the software testing phase, is outlined. Basic information on technical audits of the software development process is also provided. (orig.)

  7. [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.

  8. 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.

  9. Assuring future competence in nuclear safety in Finland

    International Nuclear Information System (INIS)

    Koskinen, K.

    2004-01-01

    To improve competence management at the regulatory body a competence analysis was carried out and a human resource plan for nuclear safety area for the near future was made. STUK studied carefully the models used in other public sector organisations and adjusted the method to its own purposes. The model used has four competence categories: substance related, management skills, common working skills and STUK related working skills. Substance related competences were defined and described at working unit level. Descriptions for the rest three categories were made at STUK level and those were common for all departments. Results of competence analysis are encouraging. Most competence areas are covered at proper level, some will need to be improved but none was totally missing. For the future challenges extra attention should be paid to knowledge management. Two separate plans were made on the basis of these results: plan for training regulatory personnel and HR-plan (at the first stage recruiting plan for next five years). It is STUK's experience that the competence analysis is worth the trouble. It gives the organisation and employees a common conception on its competences and on future needs. It also makes it easier to motivate all staff members to use their working hours on training and capability building. On the other hand it must be admitted that it takes resources and all employees have not been very anxious to do this. The results of competence analysis should lead to some improvement projects. The progress of improvement actions should be followed-up on regularly basis. It is important not to forget to communicate the results to employees

  10. Guidance for implementing an environmental, safety and health assurance program. Volume 2. A model plan for environmental, safety and health staff audits and appraisals

    International Nuclear Information System (INIS)

    Ellingson, A.C.

    1980-09-01

    This is 1 of 15 documents designed to illustrate how an Environmental, Safety and Health (ES and H) Assurance Program may be implemented. The generic definition of ES and H Assurance Programs is given in a companion document entitled An Environmental, Safety and Health Assurance Program Standard. This document is concerned with ES and H audit and appraisal activities of an ES and H Staff Organization as they might be performed in an institution whose ES and H program is based upon the ES and H Assurance Program Standard. An annotated model plan for ES and H Staff audits and appraisals is presented and discussed

  11. Guidance for implementing an environmental, safety, and health assurance program. Volume 10. Model guidlines for line organization environmental, safety and health audits and appraisals

    International Nuclear Information System (INIS)

    Ellingson, A.C.

    1981-10-01

    This is 1 of 15 documents designed to illustrate how an Environmental, Safety and Health (ES and H) Assurance Program may be implemented. The generic definition of ES and H Assurance Programs is given in a companion document entitled An Environmental, Safety and Health Assurance Program Standard. The Standard specifies that the operational level of an institution must have an internal assurance function, and this document provides guidance for the audit/appraisal portion of the operational level's ES and H program. The appendixes include an ES and H audit checklist, a sample element rating guide, and a sample audit plan for working level line organization internal audits

  12. Role of human factor in safety assurance in the nuclear industry

    International Nuclear Information System (INIS)

    Agapov, A.M.; Mikhajlov, M.V.; Novikov, G.A.

    2010-01-01

    The authors discuss the issues of human resource activities in the Rosatom Corporation that aim to achieve and maintain the required levels of safety culture and qualification of personnel involved in the operations of nuclear energy sites. These activities are supported by the appropriate resources, organisational management structure and quality control system, legislation, regulations and methodological support. It is emphasized that systematic and versatile HR-related activities in the nuclear industry represent one of the key areas of production operations that assure safety and reliability of nuclear sites at all stages of their life cycle. Especially important is the assurance of high professional level of nuclear regulators. They believe that it would appear sensible, in addition to the existing system of training, to engage the mechanisms of rotation of personnel from utility organisations to regulatory authorities [ru

  13. Radiation safety and quality control assurance in X-ray diagnostics 1998

    International Nuclear Information System (INIS)

    Servomaa, A.

    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)

  14. Software quality assurance and software safety in the Biomed Control System

    International Nuclear Information System (INIS)

    Singh, R.P.; Chu, W.T.; Ludewigt, B.A.; Marks, K.M.; Nyman, M.A.; Renner, T.R.; Stradtner, R.

    1989-01-01

    The Biomed Control System is a hardware/software system used for the delivery, measurement and monitoring of heavy-ion beams in the patient treatment and biology experiment rooms in the Bevalac at the Lawrence Berkeley Laboratory (LBL). This paper describes some aspects of this system including historical background philosophy, configuration management, hardware features that facilitate software testing, software testing procedures, the release of new software quality assurance, safety and operator monitoring. 3 refs

  15. 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.

  16. Role of computers in quality assurance in the LLL Criticality Safety Program

    International Nuclear Information System (INIS)

    Koponen, B.L.

    1978-01-01

    Some of the aspects of computational criticality safety quality assurance that have been emphasized in recent years at LLL are summarized. In particular, computer code changes that have been made that help the criticality analyst reduce the number of errors that he makes and to locate those that he does make; and how a computerized ''benchmark'' data base aids him in the validation of his computational methods are discussed

  17. The performance regulatory approach in quality assurance: Its application to safety in nuclear power plants

    International Nuclear Information System (INIS)

    Sajaroff, Pedro M.

    2000-01-01

    In early 1991, the IAEA assembled an Advisory Group on the Comprehensive Revision of the Code and the Safety on Quality Assurance of the NUSS Programme. The Group was made up by specialists from a number of countries and from ISO, FORATOM, the EC and the IAEA itself, and its objective was completed in June 1995. This paper is aimed at describing the conceptual contents of the final draft of the revision 2 of the 50-C-QA Code 'Quality Assurance for Safety in Nuclear Power Plants and other Nuclear Facilities' (hereinafter, the Code) which is essentially based on performance. Although the performance regulatory approach is not new in Argentina and in other countries, what is indeed novel is applying performance based QA. In such a way the Code will contribute to preventing both QA misinterpretations (i.e., a formalistic regulatory requirement) and the execution of non-effective work without attaining the needed quality level (what may be seen as a pathological deviation of QA). The Code contains ten basic requirements to be adopted when QA programmes are established and implemented in nuclear power plants. The goal is improving safety through an improvement in the methods applied for attaining quality. In line with the current developments in quality management techniques, priority is given to effectiveness of the QA programme. All the involved individuals (that is those in the managerial level, those performing the work and those assessing the work performed) must contribute to quality in a co-ordinated manner. The revised Safety Guides are being introduced, standing out those non existing before. Interrelation between quality assurance, safety culture and quality culture is to be noted. Besides QA for safety-related software mentioned as an issue to be considered by the IAEA. (author)

  18. 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.

  19. Some considerations for assurance of reactor safety from experiences in research reactors

    International Nuclear Information System (INIS)

    Okamoto, Sunao; Nishihara, Hideaki; Shibata, Toshikazu

    1981-01-01

    For the purpose of assuring reactor safety and strengthening research in the related fields, a multi-disciplinary group was formed among university researchers, including social scientists, with a special allocation of the Grant-in-Aid from the Ministry of Education, Science and Culture. An excerpt from the first year's report (1979 -- 1980) is edited here, which contains an interpretation of Murphy's reliability engineering law, a scope of reactor diagnostic studies to be pursued at universities, and safety measures already implemented or suggested to be implemented in university research reactors. (author)

  20. Evidence for the safety assurance of the radiation associated equipments for stat-up check

    International Nuclear Information System (INIS)

    Takahashi, Yasuyuki; Igarashi, Hiroshi; Saito, Kyoko; Kawaharada, Yasuhiro; Hirano, Kunihiro; Murase, Kenya; Mochizuki, Teruhito

    2008-01-01

    Based on the new amendment of the Medical Service Law and the Pharmaceutical Affairs Law, the safety control for the medical equipments and devices was strengthened; and a radiological technologist should be stipulated as a safety control manager for the medical equipments and devices. Although it is thought that Start-up check is important for the safety assurance, the enforcement situation is not clear until now. In this report, on the occasion of the start-up of the new Law, questionnaire about the start up check (time and a check items) were investigated from 56 hospitals applying the visit interview. Modality by modality check up time was obtained from 261 institutions by the descriptive study paper type. Start-up check and arming up were applied for almost all modalities about 30 minutes before start of the clinical tests. The check up items for the medical equipments and devices depended on each hospital. Therefore, safety assurance should be established, cooperating with the medical equipment distributors, the hospital sharing the checked results for the patients' safety. (author)

  1. Compliance assurance for the safe transport of radioactive material. Safety guide

    International Nuclear Information System (INIS)

    2009-01-01

    The objectives of this Safety Guide are to assist competent authorities in the development and maintenance of compliance assurance programmes in connection with the transport of radioactive material, and to assist applicants, licensees and organizations in their interactions with competent authorities. In order to increase cooperation between competent authorities and to promote the uniform application of international regulations and recommendations, it is desirable to adopt a common approach to regulatory activities. This Safety Guide is intended to assist in accomplishing such a uniform application by recommending most of the actions for which competent authorities need to provide in their programmes for ensuring compliance with the Transport Regulations. This Safety Guide addresses radiation safety aspects of the transport of radioactive material; that is, the subjects that are covered by the Transport Regulations. Radioactive material may have other dangerous properties, however, such as explosiveness, flammability, pyrophoricity, chemical toxicity and corrosiveness; these properties are required to be taken into account in the regulatory control of the design and transport of packages. Physical protection and systems for accounting for and control of nuclear material are also discussed in this Safety Guide. These subjects are not within the scope of the Transport Regulations, but information on them is included here because they must be taken into account in the overall regulatory control of transport, especially when the regulatory framework is being established. Section 1 informs about the background, the objective, the scope and the structure of this publication. Section 2 provides recommendations on the responsibilities and functions of the competent authority. Section 3 provides information on the various national and international regulations and guides for the transport of radioactive material. Section 4 provides recommendations on carrying out

  2. 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.

  3. Report on nuclear industry quality assurance procedures for safety analysis computer code development and use

    International Nuclear Information System (INIS)

    Sheron, B.W.; Rosztoczy, Z.R.

    1980-08-01

    As a result of a request from Commissioner V. Gilinsky to investigate in detail the causes of an error discovered in a vendor Emergency Core Cooling System (ECCS) computer code in March, 1978, the staff undertook an extensive investigation of the vendor quality assurance practices applied to safety analysis computer code development and use. This investigation included inspections of code development and use practices of the four major Light Water Reactor Nuclear Steam Supply System vendors and a major reload fuel supplier. The conclusion reached by the staff as a result of the investigation is that vendor practices for code development and use are basically sound. A number of areas were identified, however, where improvements to existing vendor procedures should be made. In addition, the investigation also addressed the quality assurance (QA) review and inspection process for computer codes and identified areas for improvement

  4. Quality assurance for safety in nuclear power plants. A code of practice

    International Nuclear Information System (INIS)

    1978-01-01

    The Code of Practice is a part of the International Atomic Energy Agency's programme, referred to as the NUSS programme (Nuclear Safety Standards), for establishing Codes of Practice and Safety Guides relating to land-based stationary thermal neutron power plants. The documents are based on documentation and experience from various national systems and practices. The present document provides the recommended principles and objectives for the establishment and implementation of a quality assurance programme during design, manufacture, construction, commissioning and operation of structures, system and components important to safety. They are applicable by all those responsible for the power plant, by plant designers, suppliers, architect-engineers, plant constructors, plant operators and other organizations participating in activities affecting quality. The Lists of relevant definition and the Provisional List of NUSS Programme Titles are given

  5. One in a Million Given the Accident: Assuring Nuclear Weapon Safety

    Energy Technology Data Exchange (ETDEWEB)

    Weaver, Jason [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States)

    2015-08-25

    Since the introduction of nuclear weapons, there has not been a single instance of accidental or unauthorized nuclear detonation, but there have been numerous accidents and “close calls.” As the understanding of these environments has increased, the need for a robust nuclear weapon safety philosophy has grown. This paper describes some of the methods used by the Nuclear Weapon Complex today to assure nuclear weapon safety, including testing, modeling, analysis, and design features. Lastly, it also reviews safety’s continued role in the future and examines how nuclear safety’s present maturity can play a role in strengthening security and other areas and how increased coordination can improve safety and reduce long-term cost.

  6. Quality and Safety Assurance - Priority Task at Nuclear Power Projects Implementation

    International Nuclear Information System (INIS)

    Nenkova, B.; Manchev, B.; Tomov, E.

    2010-01-01

    Quality and safety assurance at implementation of nuclear power engineering projects is important and difficult task for realization. Many problems arise during this process, when many companies from different countries participate, with various kinds of activities and services provided. The scope of activities necessary for quality and safety assurance is therefore quite expanded and diverse. In order to increase the safety and reliability of Kozloduy NPP Plc (KNPP) Units 5 and 6, as well as to bring the units in conformity with the newest international requirements for quality and safety in the field of nuclear energy, a program for their modernization on the basis of different technical studies and assessments was implemented. The Units 5 and 6 Modernization Program of Kozloduy Nuclear Power Plant was composed of 212 modifications aimed to improve the safety, operability, and reliability of the Units. The Program was realized by stages during yearly planned outages since year 2002 to 2007, without additional outages. A major Program Objective was to extend the Units Life Time in at least 15 Years, under a continuous, safe, and reliable operation. The Modernization Program of Units 5 and 6 of the Bulgarian Nuclear Power Plant in Kozloduy was the first and for the time being the only one in the world, program in the field of nuclear power engineering, by which the full scope of recommendations for improvement of the Kozloduy NPP units was applied. The main goal of the National Electric Company, which is the Employer for the construction of new nuclear facility in Bulgaria, is after completion of all activities regarding construction of Belene NPP the plant to meet or exceed the requirements of the respective national and international quality and safety codes and standards, as well as the IAEA guidelines, as they are established. The objective of this report is to describe different aspects of the quality assurance according to the requirements of quality and

  7. Quality factors quantification/assurance for software related to safety in nuclear power plants

    International Nuclear Information System (INIS)

    Nunez McLeod, J.E.; Rivera, S.S.

    1997-01-01

    Quality assurance plan is needed to guarantee the software quality. The use of such a plan involves activities that should take place all along the life cycle, and which can be evaluated using the so called quality factors. This is due to the fact that the quality itself cannot be measured, but some of its manifestations can be used for this purpose. In the present work, a methodology to quantify a set of quality factors is proposed, for software based systems to be used in safety related areas in nuclear power plants. (author) [es

  8. Kilowatt isotope power system. Phase II plan. Volume V. Safety, quality assurance and reliability

    International Nuclear Information System (INIS)

    1978-01-01

    The development of a Kilowatt Isotope Power System (KIPS) was begun in 1975 for the purpose of satisfying the power requirements of satellites in the 1980's. The KIPS is a 238 PuO 2 -fueled organic Rankine cycle turbine power system to provide a design output of 500 to 2000 W. Included in this volume are: launch and flight safety considerations; quality assurance techniques and procedures to be followed through system fabrication, assembly and inspection; and the reliability program made up of reliability prediction analysis, failure mode analysis and criticality analysis

  9. 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.

  10. 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.

  11. Quality assurance of radiotherapy in cancer treatment. Toward improvement of patient safety and quality of care

    International Nuclear Information System (INIS)

    Ishikura, Satoshi

    2008-01-01

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

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

    Science.gov (United States)

    Ishikura, Satoshi

    2008-11-01

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

  13. One complex tool and three simple approaches to the improvement of quality assurance and safety in external beam radiotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Salinas, F.; Sansogne, R.; Arbiser, S.; Suarez, V., E-mail: flavio.salinas@rtp.com.ar [Vidt Centro Medico (Argentina); Franco, M., E-mail: mauricio.franco@rtp.com.ar [Centro de Radioterapia San Juan (Argentina); Escobar, J., E-mail: jorge.escobar@iprc.com.ar [Instituto Privado de Radioterapia Cuyo, Buenos Aires (Argentina)

    2013-10-01

    Quality assurance and safety controls in radiation therapy delivery processes that involve the Physics Department of an institution are commonly time consuming tasks. Carrying out daily controls in very busy clinics without compromising patient schedule is challenging. This work describes the usage of Electronic Portal Imaging Devices in combination with some in-house software to simplify and systematize three different tasks of the Physics Department Quality Assurance Program, improving the easiness, reliability and velocity of daily tests. (author)

  14. One complex tool and three simple approaches to the improvement of quality assurance and safety in external beam radiotherapy

    International Nuclear Information System (INIS)

    Salinas, F.; Sansogne, R.; Arbiser, S.; Suarez, V.; Franco, M.; Escobar, J.

    2013-01-01

    Quality assurance and safety controls in radiation therapy delivery processes that involve the Physics Department of an institution are commonly time consuming tasks. Carrying out daily controls in very busy clinics without compromising patient schedule is challenging. This work describes the usage of Electronic Portal Imaging Devices in combination with some in-house software to simplify and systematize three different tasks of the Physics Department Quality Assurance Program, improving the easiness, reliability and velocity of daily tests. (author)

  15. Material & equipment, procurement & maintenance: Impact on blood safety.

    Science.gov (United States)

    Emmanuel, Jean C

    2010-01-01

    Blood Transfusion Safety is dependent on effectively organised and managed blood services, which have adequate financial resources, skilled manpower, appropriate infrastructure and quality management systems in place. 80% of the world's population has access to 20% of the supply blood products, of which little is consistently safe. HIV highlighted the importance of blood safety. The lack of effective blood services in low human development index (LHDI), developing countries, has lead to international funding and capacity building for more than three decades. The initial strategies focused on providing HIV testing reagents to prevention transmission, however this only addresses one part of blood safety. Blood safety is not only dependent on preventing HIV transmission. In many populations there are other infectious agents, which have a higher prevalence. Ensuring the correct blood is provided to the patient depends on: well managed services with effective leadership and adequate budgets; capacity building and retention of skilled experienced staff; availability of laboratory equipment, correctly maintained; blood cold chain systems; procedures for tendering, purchasing and ensuring an unbroken supply of reagents and consumables; and quality management systems. Barriers for simplified effective tendering, procurement and contracting require urgent attention and coordination of all funding organisations to ensure an unbroken supply of reagents. Copyright 2009. Published by Elsevier Ltd.

  16. Safety analysis and review system: a Department of Energy safety assurance tool

    International Nuclear Information System (INIS)

    Rosenthal, H.B.

    1981-01-01

    The concept of the Safety Analysis and Review System is not new. It has been used within the Department and its predecessor agencies, Atomic Energy Commission (AEC) and Energy Research and Development Administration (ERDA), for over 20 years. To minimize the risks from nuclear reactor and power plants, the AEC developed a process to support management authorization of each operation through identification and analysis of potential hazards and the measures taken to control them. As the agency evolved from AEC through ERDA to the Department of Energy, its responsibilities were broadened to cover a diversity of technologies, including those associated with the development of fossil, solar, and geothermal energy. Because the safety analysis process had proved effective in a technology of high potential hazard, the Department investigated the applicability of the process to the other technologies. This paper describes the system and discusses how it is implemented within the Department

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

    Directory of Open Access Journals (Sweden)

    John C Aneke

    2017-01-01

    Full Text Available 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.

  18. Krsko NPP Quality Assurance Plan Application to Nuclear Safety Upgrade Projects (PCFV System and PAR System)

    International Nuclear Information System (INIS)

    Biscan, Romeo; Fifnja, Igor

    2014-01-01

    Nuklearna Elektrarna Krsko (NEK) has undertaken Nuclear Safety Upgrade Projects as a safety improvement driven by the lessons learned from the Fukushima-Daiichi Accident. Among other projects, new modification 1008-VA-L Passive Containment Filtered Vent (PCFV) System has been installed which acts as the last barrier minimizing the release of radioactive material into the environment in case of failure of all safety systems, and to insure containment integrity during beyond design basis accidents (BDBA). In addition, modification 1002-GH-L Severe Accident Hydrogen Control System (PAR) has been implemented to prevent and mitigate the consequences of explosive gas generation (hydrogen and carbon monoxide) in case of reactor core melting. To ensure containment integrity for all design basis accidents (DBA) and BDBA conditions, NEK has eliminated existing safety-related electrical recombiners, replaced them with two safety-related passive autocatalytic recombiners (PARs) and added 20 new PARs designed for the BDBA conditions. Krsko NPP Quality Assurance Plan has been applied to Nuclear Safety Upgrade Projects (PCFV System and PAR System) through the following activities: · Internal audit of modification process was performed. · Supplier audits were performed to evaluate QA program efficiency of the main design organization and engineering organizations. · Evaluation and approval of Suppliers were performed. · QA engineer was involved in the review and approval of 1008-VA-L and 1002-GH-L modification documentation (Conceptual Design Package, Design Modification Package, Installation Package, Field Design Change Request, Problem/Deficiency Report, and Final Documentation Package). · Purchasing documentation for modifications 1008-VA-L and 1002-GH-L (technical specifications, purchase orders) has been verified and approved by QA. · QA and QC engineers were involved in oversight of production and testing of the new 1008-VA-L and 1002-GH-L plant components.

  19. Experience in the implementation of quality assurance program and safety culture assessment of research reactor operation and maintenance

    International Nuclear Information System (INIS)

    Syarip; Suryopratomo, K.

    2001-01-01

    The implementation of quality assurance program and safety culture for research reactor operation are of importance to assure its safety status. It comprises an assessment of the quality of both technical and organizational aspects involved in safety. The method for the assessment is based on judging the quality of fulfillment of a number of essential issues for safety i.e. through audit, interview and/or discussions with personnel and management in plant. However, special consideration should be given to the data processing regarding the fuzzy nature of the data i.e. in answering the questionnaire. To accommodate this situation, the SCAP, a computer program based on fuzzy logic for assessing plant safety status, has been developed. As a case study, the experience in the assessment of Kartini research reactor safety status shows that it is strongly related to the implementation of quality assurance program in reactor operation and awareness of reactor operation staffs to safety culture practice. It is also shown that the application of the fuzzy rule in assessing reactor safety status gives a more realistic result than the traditional approach. (author)

  20. Regulatory Compliance to Assure the Safety of the Operation of a Medical Cyclotron

    International Nuclear Information System (INIS)

    Dela Cruz, Joselito

    2015-01-01

    Khealth Corporation, in Partnership with the National Kidney and Transplant Institute, has established a medical cyclotron facility to accommodate the up-and-coming needs of tracers for PET/CT in different centers and hospitals all over the country. This facility houses a 16.5 MeV GE PET trace 880 particle accelerator that can produce 14 Ci (518 GBq) of Fluorine-18. Its structure has adopted global standard designs in meeting the safety during its use, radiopharmaceutical production and distribution. Compliances were remarkably fulfilled from the building construction, machine acquisition, commissioning, operations up to the quality control and assurance. Furthermore, various regulatory challenges during the current standardization of radiopharmaceutical utilization were encountered however time dedication and efforts were wielded until all have been successfully justified and acquired. (author)

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

    Science.gov (United States)

    Sonawane, A U; Singh, Meghraj; Sunil Kumar, J V K; Kulkarni, Arti; Shirva, V K; Pradhan, A S

    2010-10-01

    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.

  2. 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.

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

    International Nuclear Information System (INIS)

    Sonawane, A.U.; Singh, Meghraj; Sunil Kumar, J.V.K.; Kulkarni, Arti; Shirva, V.K.; Pradhan, A.S.

    2010-01-01

    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. (author)

  4. 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

  5. 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.

  6. 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.

  7. Blood products: optimal use, conservation, and safety.

    Science.gov (United States)

    Cone, J; Day, L J; Johnson, G K; Murray, D G; Nelson, C L

    1990-01-01

    A review of our experience in total joint arthroplasty revealed that the cell saver was not cost-effective in the case of routine primary hip or knee replacement. Its use should be restricted to cases of revision hip and knee surgery in which infection has been ruled out. Preoperative aspiration remains the most reliable method for accomplishing this. However, if the aspiration is negative and the intra-articular fluid obtained at the time of surgery is suspicious for infection, either in appearance or on Gram stain or cell count, it is best to abandon use of the cell saver. Predonation should be routine for all hip replacement cases unless there are specific contraindications. In general, there is good acceptance of this program by patients, although a few have specifically indicated they would prefer to run the risk of homologous transfusion. Two units available for primary replacement are more than ample. In cases of revisions, a first revision justifies a minimum of 3 units. For complex revision cases involving patients with three or more previous procedures on the hip, or those requiring significant bone resection or large segment grafting, the maximum possible number of units should be obtained. Autologous blood reinfusion should be done for essentially the same indications as homologous transfusion even though risks are sharply reduced. The local source for autologous collection will then follow its own specific protocol for the disposition of remaining units. In every case, the surgical technique should be careful and directed toward limiting intraoperative blood loss.

  8. 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)

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

    International Nuclear Information System (INIS)

    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

  10. 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.

  11. IMEKO TC1-TC7 Symposium in London: The assurance as a result of blood chemical analysis by ISO-GUM and QE

    Science.gov (United States)

    Iwaki, Y.

    2010-07-01

    Degree (EFD) which thought the number of samples is important. Free degree is based on maximum likelihood method of an improved information criterion (AIC) for a Quality Control (QC). The assurance performance of ISO-GUM is come out by set up of the confidence interval [3] and is decided. The result of research of "Decided level/Minimum Detectable Concentration (DL/MDC)" was able to profit by the operation. QE has developed for the QC of industry. However, these have been processed by regression analysis by making frequency probability of a statistic value into normalized distribution. The occurrence probability of the statistics value of a fault element which is accompanied element by a natural phenomenon becomes an abnormal distribution in many cases. The abnormal distribution needs to obtain an assurance value by other method than statistical work of type B in ISO-GUM. It is tried fusion the improvement of worker by QE became important for reservation of the reliability of measurement accuracy and safety. This research was to make the result of Blood Chemical Analysis (BCA) in the field of clinical test.

  12. Cavern disposal concepts for HLW/SF: assuring operational practicality and safety with maximum programme flexibility

    International Nuclear Information System (INIS)

    McKinley, Ian G.; Apted, Mick; Umeki, Hiroyuki; Kawamura, Hideki

    2008-01-01

    Most conventional engineered barrier system (EBS) designs for HLW/SF repositories are based on concepts developed in the 1970s and 1980s that assured feasibility with high margins of safety, in order to convince national decision makers to proceed with geological disposal despite technological uncertainties. In the interval since the advent of such 'feasibility designs', significant progress has been made in reducing technological uncertainties, which has lead to a growing awareness of other, equally important uncertainties in operational implementation and challenges regarding social acceptance in many new, emerging national repository programs. As indicated by the NUMO repository concept catalogue study (NUMO, 2004), there are advantages in reassessing how previous designs can be modified and optimised in the light of improved system understanding, allowing a robust EBS to be flexibly implemented to meet nation-specific and site-specific conditions. Full-scale emplacement demonstrations, particularly those carried out underground, have highlighted many of the practical issues to be addressed; e.g., handling of compacted bentonite in humid conditions, use of concrete for support infrastructure, remote handling of heavy radioactive packages in confined conditions, quality inspection, monitoring / ease of retrieval of emplaced packages and institutional control. The CAvern REtrievable (CARE) concept reduces or avoids such issues by emplacement of HLW or SF within multi-purpose transportation / storage / disposal casks in large ventilated caverns at a depth of several hundred metres. The facility allows the caverns to serve as inspectable stores for an extended period of time (up to a few hundred years) until a decision is made to close them. At this point the caverns are backfilled and sealed as a final repository, effectively with the same safety case components as conventional 'feasibility designs'. In terms of operational practicality an d safety, the CARE

  13. Quality assurance of clinical transfusion practice by implementation of the privilege of blood prescription and computerized prospective audit of blood requests.

    Science.gov (United States)

    Marconi, M; Almini, D; Pizzi, M N; Riccardi, D; Bergamaschi, W; Giovanetti, A M; Rebulla, P; Sirchia, G

    1996-03-01

    Guidelines, algorithms and recommendations have been issued in the attempt to ensure appropriateness of transfusion practice, but the results are less than satisfactory, mainly due to the difficulty to turn paper procedures into actual practice. In our hospital we have tried to overcome this difficulty through the implementation of a quality assurance programme which includes giving the privilege of nonurgent blood prescription to a limited number of physicians and a computerized prospective audit of blood requests. The latter is performed through verification of the compliance of blood requests, which are designed to include a patient's laboratory and clinical data, with hospital guidelines for the proper use of blood. In the 12 months since implementation of the computerized prospective audit the transfusion service has evaluated 7884 requests. Of these, 63.4% (n = 4998) were for red blood cells, 21.1% (n = 1664) for platelets and 15.5% (n = 1222) for fresh frozen plasma. The prospective audit showed that 96.8% and 98.1% of requests for red units and platelets were appropriate, respectively. Conversely, approximately 27% of plasma requests did not comply with guidelines, mainly because the evidence of coagulopathy was missing. However, inappropriateness of plasma requests for elective general surgery decreased from 39% at the onset of the programme to 14% in the last trimester considered. Moreover, the evaluation by retrospective audit of the proportion of patients transfused with both red blood cells and plasma in the perioperative period out of those transfused with red blood cells only, as an indicator of unwanted reconstitution of whole blood, showed that this proportion decreased from 47.6% (320/672) in the 12 months before implementation of computerized audit to 37.8% (244/646) in the following 12 months (difference = -9.8%, 95% confidence interval of the difference from -4.5% to -15.1%; P audit is a useful tool for assuring the quality of blood requesting.

  14. Supportive measures toward safety assurance of post-disaster Fukushima Daiichi Nuclear Power Plant

    International Nuclear Information System (INIS)

    Hatazawa, Mamoru

    2012-01-01

    Toshiba group had taken supportive measures toward safety assurance of post-disaster Fukushima Daiichi Nuclear Power Plant, such as active water treatment, upgrade core cooling capability with additional water injection rout of core spray spargers, alternative cooling system of spent fuel pool with air cooler and nitrogen injection into reactor containment vessel from portable air separation system for nitrogen generation. As for a water treatment system for handling the radioactive water that had built up in the basement of the turbine building from injected water for cooling fuel debris, it was implemented at first by water treatment equipment from Areva and Kurion and now by Simplified Active Water Retrieve and Recovery System (SARRY) which Toshiba had newly developed as redundant system. Purified water could be reused for circulating injected water for reactor cooling. Strenuous efforts would be made for installation of cover building for fuel removal from spent fuel pool of unit 3 reactor and technology development for fuel debris removal using remote control robots. Portable gamma camera had been developed for decontamination works of radiation 'hot spot'. With loading SARRY on truck, mobile contaminated water treatment and contaminated soil purification system using oxalic acid solution for cesium extraction had been developed to contribute environmental remedial action in surrounding areas. (T. Tanaka)

  15. Technical assistance to Department of Energy/Office of Operational Safety Assurance Program for remedial action

    International Nuclear Information System (INIS)

    Denham, D.H.; Cross, F.T.; Kennedy, W.E. Jr.; Marks, S.; Soldat, J.K.; Stenner, R.D.

    1986-01-01

    This project was initiated in FY 1984 to provide technical assistance to the Department of Energy (DOE), Office of Operational Safety (OOS) in developing and implementing its Assurance Program for Remedial Action (APRA), i.e., overview of the DOE remedial action programs. During this second year of the project,* the technical assistance included report and procedure reviews, and assistance with conducting the Uranium Mill Tailings Remedial Action Program (UMTRAP) Office (DOE/AL) appraisal. This included participation in preappraisal visits to UMTRAP sites in Canonsburg, Pennsylvania; Grand Junction, Colorado; and Salt Lake City, Utah. Pacific Northwest Laboratory (PNL) also transferred the PNL-developed document review software to the Oak Ridge Associated Universities (ORAU) staff in Grand Junction, Colorado, in anticipation of future document reviews by the ORAU staff. Other accomplishments have included publication of two formal documents and three project reports, preparation and presentation of five topical reports at national and international meetings, two foreign trip reports, and comments on proposed draft standards of the Environmental Protection Agency (40 CFR 193). The project manager has also participated on National Council on Radiation Protection and Measurements (NCRP) and American Society for Testing and Materials (ASTM) subcommittees developing decommissioning standards, as well as International Atomic Energy Agency (IAEA) advisory groups developing environmental monitoring guidelines

  16. Margins Associated with Loss of Assured Safety for Systems with Multiple Time-Dependent Failure Modes.

    Energy Technology Data Exchange (ETDEWEB)

    Helton, Jon C. [Arizona State Univ., Tempe, AZ (United States); Brooks, Dusty Marie [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Sallaberry, Cedric Jean-Marie. [Engineering Mechanics Corp. of Columbus, OH (United States)

    2018-02-01

    Representations for margins associated with loss of assured safety (LOAS) for weak link (WL)/strong link (SL) systems involving multiple time-dependent failure modes are developed. The following topics are described: (i) defining properties for WLs and SLs, (ii) background on cumulative distribution functions (CDFs) for link failure time, link property value at link failure, and time at which LOAS occurs, (iii) CDFs for failure time margins defined by (time at which SL system fails) – (time at which WL system fails), (iv) CDFs for SL system property values at LOAS, (v) CDFs for WL/SL property value margins defined by (property value at which SL system fails) – (property value at which WL system fails), and (vi) CDFs for SL property value margins defined by (property value of failing SL at time of SL system failure) – (property value of this SL at time of WL system failure). Included in this presentation is a demonstration of a verification strategy based on defining and approximating the indicated margin results with (i) procedures based on formal integral representations and associated quadrature approximations and (ii) procedures based on algorithms for sampling-based approximations.

  17. Safety assurance in radioactive waste management at nuclear power plants of the Northwest region of Russia

    Energy Technology Data Exchange (ETDEWEB)

    Safonov, Igor

    1999-07-01

    This presentation describes the two large operating nuclear power plants (NPP) in Northwest Russia, the Kola NPP and the Leningrad NPP. The four units at Kola are tank-type pressurised water reactors of 440 MW (electric) while the four Leningrad reactors are 1000 MW (electric) of RBMK type. Gosatomnadzor of Russia regularly conducts so-called target inspections on safety assurance for radioactive waste management at NNP. Among the many items checked during such inspections are the existence and realisation of an action plan for waste reduction, the technical state of equipment and the compliance with previous directions. The management of liquid, solid and gaseous radioactive wastes is described in some detail, and so are the violations revealed at both sites. There is also some discussion of modernisation plans for waste management. It is stated that the ecological impact of the plants is negligible and there is no hazard to people or environment. The presentation concludes with some suggestions for improving the licensing requirements for waste management.

  18. Safety assurance in radioactive waste management at nuclear power plants of the Northwest region of Russia

    International Nuclear Information System (INIS)

    Safonov, Igor

    1999-01-01

    This presentation describes the two large operating nuclear power plants (NPP) in Northwest Russia, the Kola NPP and the Leningrad NPP. The four units at Kola are tank-type pressurised water reactors of 440 MW (electric) while the four Leningrad reactors are 1000 MW (electric) of RBMK type. Gosatomnadzor of Russia regularly conducts so-called target inspections on safety assurance for radioactive waste management at NNP. Among the many items checked during such inspections are the existence and realisation of an action plan for waste reduction, the technical state of equipment and the compliance with previous directions. The management of liquid, solid and gaseous radioactive wastes is described in some detail, and so are the violations revealed at both sites. There is also some discussion of modernisation plans for waste management. It is stated that the ecological impact of the plants is negligible and there is no hazard to people or environment. The presentation concludes with some suggestions for improving the licensing requirements for waste management

  19. 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.

  20. The status of blood safety in ECO member states

    Science.gov (United States)

    Seighali, Fariba; Hosseini Divkolaye, Nasim S.; Koohi, Ebrahim; Pourfathollah, Ali A.; Rahmani, Ahmad M.

    2015-01-01

    Background Access to the information concerning blood safety is essential for managing problems and overcoming the challenges that are faced in any given region. Information on the availability and safety of blood in countries of the Economic Cooperation Organisation (ECO) is largely lacking. To address this problem, the Iranian Blood Transfusion Organisation, in collaboration with other ECO member states, initiated a research project in 2009 to collect, analyse and compare statistics on blood safety in the region. Materials and methods A modified and summarised version of the Global Database on Blood Safety (GDBS) questionnaire was used to collect data. The questionnaire was sent to all ten countries in the ECO region. The heads of the national transfusion services or focal points were requested to complete the form. Related literature and websites were also reviewed. Results Only three countries (Afghanistan, Iran and Turkey) completed the questionnaire, while other countries provided their available data on some parts of the questionnaire. The number of donations per year varied from 5 to 27/1,000 population. The rate of donors positive for human immunodeficiency virus ranged from 0.003% to 0.2%. The rate of donors positive for hepatitis C virus antibody varied from 0.05% to 3.9% while that of hepatitis B virus surface antigen ranged from 0.15% to 3.91% respectively. Discussion There is very clear diversity in blood transfusion services among ECO member states. Most countries in the region do not have a data-recording system. It is generally estimated that the need for blood is much higher than the supply in this region. Deficiencies in donor screening and a high prevalence of transfusion-transmitted infections are other important challenges. PMID:26192779

  1. Technical foundations for quality assurance of systems engineering activities for safety assessment

    International Nuclear Information System (INIS)

    Oren, T.I.; Elzas, M.S.

    1987-01-01

    Basic system design axioms and a framework for design and test derivation based on structural design are presented. Over thirty quality assurance issues are elaborated on. New dimensions to quality assurance issues in the artificial intelligence era are discussed. The last part of the article is a sequel of another one titled: ''Mode reliability and software quality assurance in simulation of nuclear fuel waste management systems'' which was published in the Proceedings of the 1985 Waste Management Conference

  2. Transfusion safety: is this the business of blood centers?

    Science.gov (United States)

    Slapak, Colleen; Fredrich, Nanci; Wagner, Jeffrey

    2011-12-01

    ATSO is in a unique position to break down organizational silos between hospitals and blood centers through the development of a collaborative relationship between the two entities. Use of the TSO as blood center staff centralizes the role into a consultative position thereby retaining the independence of the hospitals. The TSO position then becomes a value-added service offered by the blood center designed to supplement processes within the hospital.Whether the TSO is based in the hospital or the blood center, improvements are gained through appropriate utilization of blood components, reductions in hospital costs, ongoing education of hospital staff involved in transfusion practice, and increased availability of blood products within the community. Implementation and standardization of best practice processes for ordering and administration of blood products developed by TSOs leads to improved patient outcomes. As a liaison between hospitals and blood centers, the TSO integrates the mutual goal of transfusion safety: the provision of the safest blood product to the right patient at the right time for the right reason.

  3. The potential of viral metagenomics in blood transfusion safety.

    Science.gov (United States)

    Sauvage, V; Gomez, J; Boizeau, L; Laperche, S

    2017-09-01

    Thanks to the significant advent of high throughput sequencing in the last ten years, it is now possible via metagenomics to define the spectrum of the microbial sequences present in human blood samples. Therefore, metagenomics sequencing appears as a promising approach for the identification and global surveillance of new, emerging and/or unexpected viruses that could impair blood transfusion safety. However, despite considerable advantages compared to the traditional methods of pathogen identification, this non-targeted approach presents several drawbacks including a lack of sensitivity and sequence contaminant issues. With further improvements, especially to increase sensitivity, metagenomics sequencing should become in a near future an additional diagnostic tool in infectious disease field and especially in blood transfusion safety. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  4. Plasma fractionation, a useful means to improve national transfusion system and blood safety: Iran experience.

    Science.gov (United States)

    Cheraghali, A M; Abolghasemi, H

    2009-03-01

    In 1974, the government of Iran established Iranian Blood Transfusion Organization (IBTO) as national and centralized transfusion system. Since then donations of blood may not be remunerated and therapy with blood and its components are free of charges for all Iranian patients. Donations are meticulously screened through interviewing donors and lab testing the donations using serological methods. Currently, Iranian donors donate 1735 00 units of blood annually (donation index: 25/1000 population). Implementation of a highly efficient donor selection programme, including donors interview, establishment of confidential unit exclusion programme and laboratory screening of donated bloods by IBTO have led to seroprevalence rates of 0.41%, 0.12% and 0.004% for HBV, HCV and HIV in donated bloods respectively. Since 2004, IBTO has initiated a programme to enter into a contract fractionation agreement for the surplus of recovered plasma produced in its blood collecting centres. Although IBTO has used this project as a mean to improve national transfusion system through upgrading its quality assurance systems, IBTO fractionation project has played a major role in improving availability of plasma-derived medicines in Iran. During 2006-2007, this project furnished the Iran market with 44% and 14% of its needs to the intravenous immunoglobulin and albumin, respectively. Iranian experience showed that contract fractionation of plasma in countries with organized centralized transfusion system, which lack national plasma fractionation facility, in addition to substantial saving on national health resource and enhancing availability of plasma-derived medicines, could serve as a useful means to improve national blood safety profile.

  5. 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)

  6. Automated nucleic acid amplification testing in blood banks: An additional layer of blood safety

    Directory of Open Access Journals (Sweden)

    Pragati Chigurupati

    2015-01-01

    Full Text Available Context: A total of 30 million blood components are transfused each year in India. Blood safety thus becomes a top priority, especially with a population of around 1.23 billion and a high prevalence rate of human immunodeficiency virus (HIV, hepatitis B virus (HBV and hepatitis C virus (HCV in general population. Nucleic acid amplification testing (NAT in blood donor screening has been implemented in many developed countries to reduce the risk of transfusion-transmitted viral infections (TTIs. NAT takes care of the dynamics of window period of viruses and offers the safest blood pack for donation. Aims: The aim of this study is to show the value of NAT in blood screening. Settings and Design: Dhanavantari Blood Bank, Rajahmundry, Andhra Pradesh, India. Subjects and Methods: Over a period of 1 year from January 2012 to December 2012, a total number of 15,000 blood donor samples were subjected to tests for HIV, HBV, and HCV by enzyme-linked immunosorbent assay (ELISA method and 8000 ELISA nonreactive samples were subjected for NAT using multiplex polymerase chain reaction technology. Results: Of the 15,000 donors tested, 525 were seroreactive. In 8000 ELISA negative blood samples subjected to NAT, 4 donor samples were reactive for HBV. The NAT yield was 1 in 2000. Conclusions: NAT could detect HIV, HBV, and HCV cases in blood donor samples those were undetected by serological tests. NAT could interdict 2500 infectious donations among our approximate 5 million annual blood donations.

  7. IAEA's role in achieving and assuring safety in the transport of radioactive materials

    International Nuclear Information System (INIS)

    White, M.C.

    1983-01-01

    The results of the radiological impact studies, the data on shipments and the feedback from compliance assurance actions will help identify any shortcomings or weaknesses in the Regulations. The Advisory Material and the Explanatory Material, by amplifying the various requirements and elaborating the purpose and reason(s) for them, will help users understand the Regulations. These documents may also help motivate users. Quality Assurance will help prevent problems in the implementation process. Compliance Assurance will detect and lead to the rectification of failures in the implementation process. The data transfer on Certificates will aid in stopping the use of unsafe packages. 17 references

  8. Quality assurance during construction of civil engineering structures important to safety of nuclear facilities

    International Nuclear Information System (INIS)

    2011-11-01

    The present manual is developed to deal with quality assurance aspect of civil engineering structures in a greater detail. This manual gives detail to develop QA plans specific to multifarious activities of civil engineering construction

  9. An evaluation of sharp safety blood evacuation devices.

    Science.gov (United States)

    Ford, Joanna; Phillips, Peter

    This article describes an evaluation of three sharp safety blood evacuation devices in seven Welsh NHS boards and the Welsh Blood Service. Products consisted of two phlebotomy needles possessing safety shields and one phlebotomy device with wings, tubing and a retractable needle. The device companies provided the devices and appropriate training. Participating healthcare workers used the safety device instead of the conventional device to sample blood during the evaluation period and each type of device was evaluated in random order. Participants filled in a questionnaire for each type of device and then a further questionnaire comparing the two shielded evacuation needles with each other Results showed that responses to all three products were fairly positive, although each device was not liked by everyone who used it. When the two shielded evacuation devices were compared with each other, most users preferred the device with the shield positioned directly above the needle to the device with the shield at the side. However, in laboratory tests, the preferred device produced more fluid splatter than the other shielded device on activation.

  10. A modeling approach to support safety assurance in the automotive domain

    NARCIS (Netherlands)

    Luo, Y.; Brand, van den M.G.J.; Engelen, L.J.P.; Klabbers, M.D.; Selvaraj, H.; Zydek, D.; Chmaj, G.

    2015-01-01

    As safety standards are widely used in safety-critical domains, such as ISO 26262 in the automotive domain, the use of safety cases to demonstrate product safety is stimulated. It is crucial to ensure that a safety case is both correct and clear. To support this, we proposed to make use of modeling

  11. 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.

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

    OpenAIRE

    Nkohkwo, Asa?ah; Agbor, Gabriel; Asongalem, Emmanuel; Tagny, Claude; Asonganyi, Tazoacha

    2016-01-01

    Background: Despite vast improvements in transfusion services in sub-Saharan Africa over the last decade, there remain serious concerns on the safety and adequacy of the blood supply across the region. Objective: This review paper ascertains the role of pathogen reduction technology (PRT) in improving blood safety and supply adequacy in the region. Method: The state of blood safety in sub-Saharan Africa was reviewed. Meetings, seminars and correspondence were undertaken with key clinic...

  13. [Blood conservation effect and safety of shed mediastinal blood autotransfusion after cardiac surgery].

    Science.gov (United States)

    Komiya, T; Ban, K; Yamazaki, K; Date, O; Nakamura, T; Kanzaki, Y

    1998-10-01

    Autotransfusion of shed mediastinal blood after cardiac surgery has been used to reduce risks related to homologous blood transfusions. To document the efficacy and safety of autotransfusion, we compared clinical findings of 80 patients receiving shed mediastinal blood (autotransfusion group) with those of the control group of 52 patients. The amount of the autotransfusion was limited to 800 ml, given the potentially harmful effects of shed blood transfusion. The mean transfused shed volume was 314 +/- 236 ml (S.D.). The serum levels of FDP-E, D-dimer and TAT after autotransfusion were higher in the autotransfusion group than in the control group (p = 0.01, p = 0.0004, p = 0.001, respectively). However, postoperative blood loss and the rate of reexploration for bleeding were similar in the two groups. The patients receiving blood products were fewer in the autotransfusion group than those in the control group (21% vs 44%; p = 0.005). Autotransfusion did not increase postoperative complications, including infection. Thus, although autotransfusion of mediastinal shed blood has the potential to affect hemostasis, unless the amount of autotransfusion exceeds 800 ml, it appears that this method is clinically safe and effective as a mean of blood conservation.

  14. 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.

  15. 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.

  16. 49 CFR Appendix C to Part 236 - Safety Assurance Criteria and Processes

    Science.gov (United States)

    2010-10-01

    ...-safe design concept. Intrinsically fail-safe hardware circuits or systems are those that employ... system (all its elements including hardware and software) must be designed to assure safe operation with...; human errors that could impact hardware design; unsafe conditions that could occur because of an...

  17. International Conference on Human and Organizational Aspects of Assuring Nuclear Safety. Exploring 30 years of Safety Culture. Programme and Abstracts

    International Nuclear Information System (INIS)

    2016-01-01

    Thirty years ago, the International Nuclear Safety Advisory Group concluded, in its investigation of the Chernobyl accident, that one of the key lessons to be learned from that accident was the importance of a strong safety culture to maintain safe operations. Almost five years have now passed since the accident at the Fukushima Daiichi nuclear power plant, and the need to implement a systemic approach to safety that takes into account the complex and dynamic sociotechnical systems comprising nuclear infrastructure is one of the main lessons emerging from investigations. This conference will allow an international audience to take a step back and reflect upon the knowledge accumulated in the areas of human and organizational factors (HOF), safety culture and leadership for safety over the past 30 years. The objectives of the conference are to: • Review the experience gained with regard to HOF, safety culture and leadership for safety; • Share and gather experiences related to current developments, approaches, methods and research in the areas of HOF, safety culture and leadership for safety; and • Identify the future needs for building organizational resilience capabilities in order to further strengthen defence in depth for nuclear facilities and activities. The special focus of the conference will be on safety culture and the past 30 years of developments in this area.

  18. Radiation safety and quality assurance in diagnostic x-ray imaging 1999

    International Nuclear Information System (INIS)

    Servonmaa, A.

    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 safety of personnel exposed to disinfectants by introducing an Endoscopy Quality Assurance Program

    OpenAIRE

    Ahmed Gado; Basel Ebeid; Aida Abdelmohsen; Anthony Axon

    2014-01-01

    Background: Chemical disinfection is the most commonly used method in gastrointestinal endoscopy reprocessing. The main problem with chemical disinfection is that it is potentially harmful to humans. Risk assessment of employees using toxic substances is recommended and the control of exposure to these substances is required. In 2003, an endoscopy quality-assurance program was instituted in a secondary care governmental hospital in Egypt. Aim: The aim of the study was to assess the risk to...

  20. SOCTESQA - Solid Oxide Cell and Stack Testing, Safety and Quality Assurance

    OpenAIRE

    Lang, Michael; Auer, Corinna; Couturier, Karine; Nielsen, Eva Ravn; Mc Phail, Stephen; Kotsionopoulos, Nikolaos; FU, Qingxi; Liu, Qinglin

    2015-01-01

    For the successful market penetration of high temperature solid oxide fuel/electrolysis cell energy systems it is necessary to increase the quality assurance and the reliable assessment of the corresponding cells and stacks. Therefore in May 2014 the EU-funded project SOCTESQA was launched. Partners from different countries in Europe and one external party from Singapore are working together to develop uniform and industry wide test procedures and programs for solid oxide cell/stack (SOC) ass...

  1. Blood donor recruitment strategies and their impact on blood safety in Egypt.

    Science.gov (United States)

    Hussein, Eiman

    2014-02-01

    Because of the high incidence of HCV, blood safety presents a serious challenge in Egypt. Given the constrained economy which limits the implementation of nucleic acid amplification technology, proper recruitment of blood donors becomes of paramount importance. To evaluate the effectiveness of blood donor recruitment strategies, the seroprevalence of positive infectious markers among blood donors was studied. Donors' records covering the period from 2006-2012 were reviewed. Blood donations were screened for HCV antibodies, HBs antigen (HBsAg), HIV-1 and 2 and syphilis antibodies. Of 308,762 donors, 63.4% were voluntary donors (VD). VD of 2011-2012 were significantly younger than family replacement donors (RD) .The overall prevalences of HCV antibodies, HBsAg, HIV and syphilis antibodies were 4.3%, 1.22%, 0.07%, and 0.13%, respectively. All tested markers (except HIV) were significantly higher among RD, when compared to VD (P<0.0001). A consistent steady trend for decrease in HCV seropositivity was observed in RD and VD from 8.9% and 4.2% to 3.8% and 1.5%, respectively. A trend for decrease in HBsAg was demonstrated in VD from 1.2% to 0.53%. The decreasing trends in HCV antibody and HBs antigen is promising and may reflect the improved donor selection criteria. Copyright © 2013 Elsevier Ltd. All rights reserved.

  2. 78 FR 28848 - Meeting of the Advisory Committee on Blood and Tissue Safety and Availability

    Science.gov (United States)

    2013-05-16

    ... health, ethical and legal issues related to the safety of blood, blood products, and tissues; (4) the impact of various economic factors (e.g., product cost and supply) on safety and availability of blood... coordinated system to manage tissue supplies and distributions during a disaster does not exist. Past...

  3. 75 FR 28619 - Meeting of the Advisory Committee on Blood Safety and Availability

    Science.gov (United States)

    2010-05-21

    ... public health parameters around safety and availability of the blood supply and blood products, (2) broad public health, ethical and legal issues related to transfusion and transplantation safety, and (3) the implications for safety and the availability of various economic factors affecting product cost and supply...

  4. 76 FR 26300 - Meeting of the Advisory Committee on Blood Safety and Availability

    Science.gov (United States)

    2011-05-06

    ... around safety and availability of the blood supply and blood products, (2) broad public health, ethical... safety and availability of various economic factors affecting product cost and supply. In keeping with... reactions on the practices, safety, quality, efficacy, epidemiology and ethics of donations and...

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

    NARCIS (Netherlands)

    Kalkman, Cor J.

    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

  6. 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

  7. Probability evaluation in problems of structural safety and quality assurance through oriented simulation

    International Nuclear Information System (INIS)

    Puppo, A.H.

    1990-01-01

    The procedure described in this work may be considered to improve the Harbitz method by a limitation of the directions corresponding to the sampling points. By the introduction of polar coordinates n-dimensional system, these directions may be limited to those contained in an hypercone, whose axis contains the design point. Some problems with strongly convex failure domain presented in some structural systems (Igusa and Der Kiureghian, 1988; Nadim, 1990) and also in the acceptance probability of analysis and rejection of quality assurance methods may be efficiently treated. (Author) [es

  8. Situation of quality assurance for safety related buildings of nuclear power stations

    International Nuclear Information System (INIS)

    1983-01-01

    General aspects of quality assurance are discussed first. Reference is made to the legal principles of the construction decree of the State of Northrhine-Westphalia. The presently applied procedure for quality assurance can be regarded as being sufficient. The consultation of experts during all stages of the construction of the power station offers the possibility to take into account the state of science and technology at any time. In addition to the experts according to PARAGRAPH 20 of the Atomic Energy Act the licensing authorities reasonably engage an expert specialized on the construction of buildings. The structural analyses and the design documents have to be checked by a licensed examiner. Supervision (quality control) of building materials, structural parts and types of construction is performed on two levels: - Supervision carried out by the manufacturer, who has to prove the quality of his product by an orderly performance of quality control procedures based on statistical methods. - Supervision by authorized representatives, who guarantee the correct supervision of the manufacturer. The supervision by the manufacturer himself is of eminent importance. Only if this supervision is performed intensively, the limitation of the activities of authorized representatives to the degree described above is justified. (orig./HP) [de

  9. Hepatitis B Virus Blood Screening: Need for Reappraisal of Blood Safety Measures?

    Directory of Open Access Journals (Sweden)

    Daniel Candotti

    2018-02-01

    Full Text Available Over the past decades, the risk of HBV transfusion–transmission has been steadily reduced through the recruitment of volunteer donors, the selection of donors based on risk-behavior evaluation, the development of increasingly more sensitive hepatitis B antigen (HBsAg assays, the use of hepatitis B core antibody (anti-HBc screening in some low-endemic countries, and the recent implementation of HBV nucleic acid testing (NAT. Despite this accumulation of blood safety measures, the desirable zero risk goal has yet to be achieved. The residual risk of HBV transfusion–transmission appears associated with the preseroconversion window period and occult HBV infection characterized by the absence of detectable HBsAg and extremely low levels of HBV DNA. Infected donations tested false-negative with serology and/or NAT still persist and derived blood components were shown to transmit the virus, although rarely. Questions regarding the apparent redundancy of some safety measures prompted debates on how to reduce the cost of HBV blood screening. In particular, accumulating data strongly suggests that HBsAg testing may add little, if any HBV risk reduction value when HBV NAT and anti-HBc screening also apply. Absence or minimal acceptable infectious risk needs to be assessed before considering discontinuing HBsAg. Nevertheless, HBsAg remains essential in high-endemic settings where anti-HBc testing cannot be implemented without compromising blood availability. HBV screening strategy should be decided according to local epidemiology, estimate of the infectious risk, and resources.

  10. 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.

  11. 78 FR 66006 - Meeting of the Advisory Committee on Blood and Tissue Safety and Availability

    Science.gov (United States)

    2013-11-04

    ... decision making from donor to recipient. The Committee will also hear from the World Health Organization's... include: (1) Definition of public health parameters around safety and availability of blood and blood...

  12. [Organize quality assurance as in aviation; improve patient safety in Dutch hospitals].

    Science.gov (United States)

    Haerkens, Marck H T M; Beekmann, Roland T A; van den Elzen, Guus J P; Lansbergen, Michael D I; Berlijn, Dick L

    2009-01-01

    Failing teamwork is a major cause of adverse events in hospitals in the Netherlands. Training team-skills can improve the safety standards in clinical heath care. An adapted version of Crew Resource Management (CRM) training is proving to be a usable format in the hospital environment. We emphasize that paying attention to the subject of safety has to start early in medical education in order to incorporate non-technical skills into the hospital culture.

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

    Science.gov (United States)

    Nkohkwo, Asa'ah; Agbor, Gabriel; Asongalem, Emmanuel; Tagny, Claude; Asonganyi, Tazoacha

    2016-01-01

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

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

    International Nuclear Information System (INIS)

    Benedict, S.

    2015-01-01

    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

  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. 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.

  17. 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 

  18. 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

  19. Revitalizing quality assurance

    International Nuclear Information System (INIS)

    Hawkins, F.C.

    1998-01-01

    The image of someone inspecting or auditing often comes to mind when people hear the term quality assurance. Although partially correct, this image is not the complete picture. The person doing the inspecting or auditing is probably part of a traditional quality assurance organization, but that organization is only one aspect of a properly conceived and effectively implemented quality assurance system whose goal is improved facility safety and reliability. This paper introduces the underlying philosophies and basic concepts of the International Atomic Energy Agency's new quality assurance initiative that began in 1991 as part of a broad Agency-wide program to enhance nuclear safety. The first product of that initiative was publication in 1996 of a new Quality Assurance Code 50-C/SG-Q and fourteen related Safety Guides. This new suite of documents provide the technical and philosophical foundation upon which Member States can base their quality assurance programs. (author)

  20. A proposed safety assurance method and its application to the fusion experimental reactor

    International Nuclear Information System (INIS)

    Okazaki, T.; Seki, Y.; Inabe, T.; Aoki, I.

    1995-01-01

    Importance categorization and hazard identification methods have been proposed for a fusion experimental reactor. A parameter, the system index, is introduced in the categorization method. The relative importance of systems with safety functions can be classified by the largeness of the system index and whether or not the system acts as a boundary for radioactive materials. This categorization can be used as the basic principle in determining structure design assessment, seismic design criteria etc. For the hazard identification the system time energy matrix is proposed, where the time and spatial distributions of hazard energies are used. This approach is formulated more systematically than an ad-hoc identification of hazard events and it is useful to select design basis events which are employed in the assessment of safety designs. (orig.)

  1. An augmented audit program for assuring radiation safety during radiographic examination operations

    International Nuclear Information System (INIS)

    Jervey, R.A. Jr.; Papin, P.J.

    1993-01-01

    Auditing a gamma radiography program is required as part of the authorizing license. Checklists and cursory reviews are the typical approach to addressing program requirements. A more proactive approach is recommended. The audit program described was prepared for a specific set of operating conditions but can be applied to any given program. Improvements in the effectiveness of the radiography safety program can be made with additional examination and emphasis on direct observation of licensed activities

  2. Overview on recent results of the VTT's research programme on assuring nuclear power plant structural safety

    International Nuclear Information System (INIS)

    Rintamaa, R.; Aaltonen, P.; Kauppinen, P.; Keinaenen, H.; Talja, H.; Valo, M.; Wallin, K.; Toerroenen, K.

    1994-01-01

    An overview of the Finnish national research programme on the Nuclear Power Plant Structural Safety, being carried out from 1990 to 1994, is presented. The focus of this paper is on recent results in the areas of experimental and computational fracture mechanics, material deterioration due to neutron irradiation, corrosion and water chemistry, nondestructive testing methods and procedures, and verification of structural integrity assessment methods by large scale component tests. (author). 21 refs, 21 figs, 2 tabs

  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. Development of a Reliability Program approach to assuring operational nuclear safety

    International Nuclear Information System (INIS)

    Mueller, C.J.; Bezella, W.A.

    1985-01-01

    A Reliability Program (RP) model based on proven reliability techniques used in other high technology industries is being formulated for potential application in the nuclear power industry. Research findings are discussed. The reliability methods employed under NASA and military direction, commercial airline and related FAA programs were surveyed with several reliability concepts (e.g., quantitative reliability goals, reliability centered maintenance) appearing to be directly transferable. Other tasks in the RP development effort involved the benchmarking and evaluation of the existing nuclear regulations and practices relevant to safety/reliability integration. A review of current risk-dominant issues was also conducted using results from existing probabilistic risk assessment studies. The ongoing RP development tasks have concentrated on defining a RP for the operating phase of a nuclear plant's lifecycle. The RP approach incorporates safety systems risk/reliability analysis and performance monitoring activities with dedicated tasks that integrate these activities with operating, surveillance, and maintenance of the plant. The detection, root-cause evaluation and before-the-fact correction of incipient or actual systems failures as a mechanism for maintaining plant safety is a major objective of the RP

  5. Assuring nuclear safety competence into the 21. century a swedish perspective

    International Nuclear Information System (INIS)

    Lowenhielm, G.; Svensson, G.; Tiren, IN

    2000-01-01

    Many initiatives have been taken and are being considered to maintain and develop competence in the nuclear field in Sweden. The number of qualified nuclear engineering staff at the plants and at the regulatory bodies appears to be rather small for all important tasks to be carried out. Nevertheless, the current programmes indicate that one can look at future recruitment and competence with some confidence-in spite of the age profile of qualified staff with many approaching retirement. The Swedish Nuclear Power Inspectorate, (SKI), the academic community, and the Industry are conducting several research projects that support the optimistic view expressed above. Examples include: Safety research at SKI and universities: Since many years, SKI is sponsoring research in safety analysis within the framework of its Research Programme. In this programme the regulator supports two professors, one in Nuclear Power Safety at KTH and the other in the Interaction of Man, Technology and Organisation at the University of Stockholm. Swedish Centre of Nuclear Technology: A main activity of the Centre is to support PhD candidates (with scientific advice and economy) in topics related to nuclear technology. The Industry also makes great efforts to support recruitment by various initiatives: Design reconstitution projects: Each one of the older operating plants was subject to a design review that engaged a large number of young staff at the utilities and the vendors. 'Young Generation': It constitutes a communication network among young engineers at European nuclear plants, regulators, and other organisations. (authors)

  6. 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. 

  7. 76 FR 15982 - Nominations to the Advisory Committee on Blood Safety and Availability

    Science.gov (United States)

    2011-03-22

    ... Committee is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of... Mr. James Berger, Associate Public Health Advisor for Blood, Organ and Tissue Safety; Office of... Public Health Advisor for Blood, Organ and Tissue Safety. Contact information for Mr. Berger is provided...

  8. 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

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

    OpenAIRE

    Maria Śmiechowska; Filip Kłobukowski

    2016-01-01

    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 au...

  10. Nursing Student Experiences Regarding Safe Use of Electronic Health Records: A Pilot Study of the Safety and Assurance Factors for EHR Resilience Guides.

    Science.gov (United States)

    Whitt, Karen J; Eden, Lacey; Merrill, Katreena Collette; Hughes, Mckenna

    2017-01-01

    Previous research has linked improper electronic health record configuration and use with adverse patient events. In response to this problem, the US Office of the National Coordinator for Health Information Technology developed the Safety and Assurance Factors for EHR Resilience guides to evaluate electronic health records for optimal use and safety features. During the course of their education, nursing students are exposed to a variety of clinical practice settings and electronic health records. This descriptive study evaluated 108 undergraduate and 51 graduate nursing students' ratings of electronic health record features and safe practices, as well as what they learned from utilizing the computerized provider order entry and clinician communication Safety and Assurance Factors for EHR Resilience guide checklists. More than 80% of the undergraduate and 70% of the graduate students reported that they experienced user problems with electronic health records in the past. More than 50% of the students felt that electronic health records contribute to adverse patient outcomes. Students reported that many of the features assessed were not fully implemented in their electronic health record. These findings highlight areas where electronic health records can be improved to optimize patient safety. The majority of students reported that utilizing the Safety and Assurance Factors for EHR Resilience guides increased their understanding of electronic health record features.

  11. 78 FR 12062 - Nominations to the Advisory Committee on Blood and Tissue Safety and Availability

    Science.gov (United States)

    2013-02-21

    ... Committee is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of... Mr. James Berger, Senior Advisor for Blood Policy; Division of Blood and Tissue Safety and...: (240) 453-8803. FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Senior Advisor for Blood Policy...

  12. Disposal of radioactive wastes. A review of IAEA efforts to assure safety

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1961-07-15

    A variety of methods for the discharge of radioactive wastes into the ground, into water and into the air were described at an international conference in Monaco in November 1959, organized by IAEA jointly with UNESCO and with the co-operation of FAO. Many of the experts at the conference were of the view that most of the proposed, or actually applied, methods of waste disposal were compatible with safety requirements. Some differences of opinion existed about disposal into the sea. It was generally agreed that much additional research was necessary for devising the most effective and economical methods of disposal and gaining a better knowledge of the effects of the various types of disposal operations.

  13. Towards assuring the continued performance of safety-related concrete structures in nuclear power plants

    International Nuclear Information System (INIS)

    Naus, D.J.; Oland, C.B.; Ellingwood, B.; Mori, Y.; Arndt, E.G.

    1993-01-01

    The Structural Aging (SAG) Program is addressing the aging management of safety-related concrete structures in nuclear power plants for the purpose of providing improved technical bases for their continued service. Pertinent concrete structures are described in terms of their importance, design considerations, and materials of construction. Degradation factors which can potentially impact the ability of these structures to meet their functional and performance requirements are identified. A review of the performance history of the concrete components in nuclear power plants is provided. Accomplishments of the SLAG Program are summarized, i.e., development of the structural materials information center, development of a structural aging assessment methodology, evaluation of models for predicting the remaining life of in-service concrete, review of in-service inspection methods, and development of a methodology for reliability-based condition assessment and life prediction of concrete structures. On-going activities are also described

  14. The method for assurance to operational safety of cryogenics equipment through definite maintenance

    International Nuclear Information System (INIS)

    Anghel, Vasile

    2004-01-01

    The present paper reports about a method of ensuring operational safety of cryogenics equipment through specific maintenance measures which imply a definite concept of maintainability and operational reliability, methods of maintenance, necessary logistic and necessary personnel. The stages of the concept should succeed in a logical order and must be based on detailed analyses of the process of maintenance. The method starts from the operation conditions of cryogenic equipment in nuclear regime. Thus maintenance policy must be well defined within the boundaries of the nuclear plant through definition of coherent objectives and responsibility delegation for the personnel implied in maintenance activity. This method ensures performance in maintenance and an efficient feedback from equipment analysis. (author)

  15. Implementing a "quality by design" approach to assure the safety and integrity of botanical dietary supplements.

    Science.gov (United States)

    Khan, Ikhlas A; Smillie, Troy

    2012-09-28

    Natural products have provided a basis for health care and medicine to humankind since the beginning of civilization. According to the World Health Organization (WHO), approximately 80% of the world population still relies on herbal medicines for health-related benefits. In the United States, over 42% of the population claimed to have used botanical dietary supplements to either augment their current diet or to "treat" or "prevent" a particular health-related issue. This has led to the development of a burgeoning industry in the U.S. ($4.8 billion per year in 2008) to supply dietary supplements to the consumer. However, many commercial botanical products are poorly defined scientifically, and the consumer must take it on faith that the supplement they are ingesting is an accurate representation of what is listed on the label, and that it contains the purportedly "active" constituents they seek. Many dietary supplement manufacturers, academic research groups, and governmental organizations are progressively attempting to construct a better scientific understanding of natural products, herbals, and botanical dietary supplements that have co-evolved with Western-style pharmaceutical medicines. However, a deficiency of knowledge is still evident, and this issue needs to be addressed in order to achieve a significant level of safety, efficacy, and quality for commercial natural products. The authors contend that a "quality by design" approach for botanical dietary supplements should be implemented in order to ensure the safety and integrity of these products. Initiating this approach with the authentication of the starting plant material is an essential first step, and in this review several techniques that can aid in this endeavor are outlined.

  16. Safety assurance of non-deterministic flight controllers in aircraft applications

    Science.gov (United States)

    Noriega, Alfonso

    Loss of control is a serious problem in aviation that primarily affects General Aviation. Technological advancements can help mitigate the problem, but the FAA certification process makes certain solutions economically unfeasible. This investigation presents the design of a generic adaptive autopilot that could potentially lead to a single certification for use in several makes and models of aircraft. The autopilot consists of a conventional controller connected in series with a robust direct adaptive model reference controller. In this architecture, the conventional controller is tuned once to provide outer-loop guidance and navigation to a reference model. The adaptive controller makes unknown aircraft behave like the reference model, allowing the conventional controller to successfully provide navigation without the need for retuning. A strong theoretical foundation is presented as an argument for the safety and stability of the controller. The stability proof of direct adaptive controllers require that the plant being controlled has no unstable transmission zeros and has a nonzero high frequency gain. Because most conventional aircraft do not readily meet these requirements, a process known as sensor blending was used. Sensor blending consists of using a linear combination of the plant's outputs that has no unstable transmission zeros and has a nonzero high frequency gain to drive the adaptive controller. Although this method does not present a problem for regulators, it can lead to a steady state error in tracking applications. The sensor blending theory was expanded to take advantage of the system's dynamics to allow for zero steady state error tracking. This method does not need knowledge of the specific system's dynamics, but instead uses the structure of the A and B matrices to perform the blending for the general case. The generic adaptive autopilot was tested in two high-fidelity nonlinear simulators of two typical General Aviation aircraft. The results

  17. Use of decision criteria based on expected values to support decision-making in a production assurance and safety setting

    International Nuclear Information System (INIS)

    Aven, T.; Flage, R.

    2009-01-01

    We consider decision problems related to production assurance and safety. The issue is to what extent we should use decision criteria based on expected values, such as the expected net present value (E[NPV]) and the expected cost per expected number of saved lives (ICAF), to guide the decision. Such criteria are recognised as practical tools for supporting decision-making under uncertainty, but is uncertainty adequately taken into account by these criteria? Based on the prevailing practice and the existing literature, we conclude that there is a need for a clarification of the rationale of these criteria. Adjustments of the standard approaches have been suggested to reflect risks and uncertainties, but can cautionary and precautionary concerns be replaced by formulae and mechanical procedures? These issues are discussed in the present paper, particularly addressing the company level. We argue that the search for such formulae and procedures should be replaced by a more balanced perspective acknowledging that there will always be a need for management review and judgment beyond the realm of the analyses. Most of the suggested adjustments of the E[NPV] and ICAF approaches should be avoided. They add more confusion than value.

  18. Confidence in the safety of blood for transfusion: the effect of message framing.

    Science.gov (United States)

    Farrell, K; Ferguson, E; James, V; Lowe, K C

    2001-11-01

    Blood transfusion is a universally used, life-saving medical intervention. However, there are increasing concerns among patients about blood safety. This study investigates the effect of message framing, a means of presenting information, on confidence in blood transfusion safety. The same factual information regarding the safety of blood for transfusion was presented to a sample of 254 adult students (donors and nondonors) as either a gain frame (lives saved), a loss frame (lives lost), or a combined frame (a loss frame expressed in a positive context). This provided a basic two-way, between-subjects design with 1) blood donation history (donors vs. nondonors) and 2) message frame (gain, loss, and combined) functioning as the between-groups factors. It was hypothesized that participants would consider blood safer if information was presented as a gain frame. The role of stress appraisals as potential mediators of the framing effect was also explored. As predicted, participants receiving the gain-frame information were significantly more confident of the safety of blood for transfusion than those receiving loss-frame information or both. This was unaffected by donation history or appraisals of stress associated with transfusion. The extent to which blood was considered safe was negatively associated, independently of framing effects, with perceptions that transfusion was threatening. Information about transfusion should be conveyed to patients in a form focusing on the positive, rather than the negative, known facts about the safety of blood.

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

    International Nuclear Information System (INIS)

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

    2009-01-01

    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.

  20. 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.

  1. 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.

  2. Safety of retransfusing shed blood after local infiltration analgesia in total knee arthroplasty

    NARCIS (Netherlands)

    Thomassen, B.J.; Pool, L.; Van Der Flier, R.; Stienstra, R.; in 't Veld, B.A.

    2012-01-01

    We investigated the safety of LIA (local infiltration analgesia) combined with retransfusion of drained blood. Total knee arthroplasty patients received two peri-articular injections during surgery followed by continuous infusion, both with ropivacaine (567 mg). Ropivacaine plasma concentrations

  3. Safety and frequency of whole blood donations from elderly donors.

    Science.gov (United States)

    Müller-Steinhardt, M; Müller-Kuller, T; Weiss, C; Menzel, D; Wiesneth, M; Seifried, E; Klüter, H

    2012-02-01

    Within the coming decades, a steadily growing demand for blood products will face a shrinking blood donor population in many countries. After increasing the donor age of repeat donors for whole blood donation (WB) from 68 to 70 years in 2009 in our Blood Service, we investigated whether this is sufficient as a safe and effective strategy to sustain future blood supply. Between 1 March 2009 and 28 February 2011, WB donations from donors aged between 69 and 70 and their proportion of total donations in 2010 were determined. We analysed adverse reaction rates in donors with respect to sex and age and calculated mean annual donation frequencies. Of all invited donors, 32·5% responded and contributed 0·98% (men) and 0·56% (women) to all WB units collected in 2010. The overall and systemic adverse reaction rate per 1·000 WB donations declined by age [men: 1·10 (95%CI: 0·84-1·35) vs. 0 (0-0·8), P donation frequencies were strongly correlated with increasing age (men: r = 0·953, P donate blood. Thus, we consider donations from repeat donors aged 69-70 safe and suggest it a powerful short- to midterm strategy to, at least partially, overcome the challenges of the demographic change. © 2011 The Author(s). Vox Sanguinis © 2011 International Society of Blood Transfusion.

  4. 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.

  5. Safety and radiation risks in the labelling of blood cells

    International Nuclear Information System (INIS)

    Gonzalez, B.M.

    1994-01-01

    Risk in the management of radioactive material and biological exposition to infectious agents. Protocols and normative to observe GOOD RADIOPHARMACY Practices. Main infectious agents that may be transmitted during preparation of a blood cell radiopharmaceutical. Problems of contamination

  6. 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...

  7. Perceived blood transfusion safety: A cross-European comparison

    NARCIS (Netherlands)

    Merz, E.M.; Zijlstra, B.J.H.; de Kort, W.L.A.M.

    2016-01-01

    Background and Objectives During the past decades, blood transfusions have become an ever safer clinical procedure in developed countries. Extensive donor screening together with improved infectious disease testing has led to a minimization of risks for transfusion recipients. Still, the general

  8. Perceived blood transfusion safety: a cross-European comparison

    NARCIS (Netherlands)

    Merz, E.-M.; Zijlstra, B. J. H.; de Kort, W. L. A. M.

    2016-01-01

    During the past decades, blood transfusions have become an ever safer clinical procedure in developed countries. Extensive donor screening together with improved infectious disease testing has led to a minimization of risks for transfusion recipients. Still, the general public perceives the process

  9. Perceived blood transfusion safety. A cross-European comparison

    NARCIS (Netherlands)

    Merz, E.M.; Zijlstra, B.J.H.; De Kort, W.L.A.M.

    2016-01-01

    Background and Objectives: During the past decades, blood transfusions have become an ever safer clinical procedure in developed countries. Extensive donor screening together with improved infectious disease testing has led to a minimization of risks for transfusion recipients. Still, the general

  10. [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.

  11. Quality assurance for safety in nuclear power plants and other nuclear installations. Code and safety guides Q1-Q14. A publication within the NUSS programme

    International Nuclear Information System (INIS)

    1996-01-01

    The code provides the basic requirements for establishing and implementing quality assurance programmes for the stages of siting, design, construction, commissioning, operation and decommissioning of nuclear power plants. These basic requirements apply to all individuals and organizations, including designers, suppliers, constructors, manufacturers and operators. The basic quality assurance requirements presented in this Code also apply, with appropriate modifications, to nuclear installations other than nuclear power plants

  12. Towards improvement in quality assurance

    International Nuclear Information System (INIS)

    1987-03-01

    This first document in the series of the International Nuclear Safety Advisory Group (INSAG) Technical Notes is a general guideline for the establishment of effective quality assurance procedures at nuclear facilities. It sets out primary requirements such as quality objectives, methods for measuring the effectiveness of the quality assurance programme, priority of activities in relation to importance of safety of items, motivation of personnel

  13. Xenotropic murine leukemia virus-related virus does not pose a risk to blood recipient safety.

    Science.gov (United States)

    Dodd, Roger Y; Hackett, John; Linnen, Jeffrey M; Dorsey, Kerri; Wu, Yanyun; Zou, Shimian; Qiu, Xiaoxing; Swanson, Priscilla; Schochetman, Gerald; Gao, Kui; Carrick, James M; Krysztof, David E; Stramer, Susan L

    2012-02-01

    When xenotropic murine leukemia virus-related virus (XMRV) was first reported in association with chronic fatigue syndrome, it was suggested that it might offer a risk to blood safety. Thus, the prevalence of the virus among blood donors and, if present, its transmissibility by transfusion need to be defined. Two populations of routine blood donor samples (1435 and 13,399) were obtained for prevalence evaluations; samples from a linked donor-recipient repository were also evaluated. Samples were tested for the presence of antibodies to XMRV-related recombinant antigens and/or for XMRV RNA, using validated, high-throughput systems. The presence of antibodies to XMRV could not be confirmed among a total of 17,249 blood donors or recipients (0%; 95% confidence interval [CI], 0%-0.017%); 1763 tested samples were nonreactive for XMRV RNA (0%; 95% CI, 0%-0.17%). Evidence of infection was absent from 109 recipients and 830 evaluable blood samples tested after transfusion of a total of 3741 blood components. XMRV and related murine leukemia virus (MLV) markers are not present among a large population of blood donors and evidence of transfusion transmission could not be detected. Thus, these viruses do not currently pose a threat to blood recipient safety and further actions relating to XMRV and MLV are not justified. © 2012 American Association of Blood Banks.

  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. Quality assurance

    International Nuclear Information System (INIS)

    Kunich, M.P.; Vieth, D.L.

    1989-01-01

    This paper provides a point/counterpoint view of a quality assurance director and a project manager. It presents numerous aspects of quality assurance requirements along with analyses as to the value of each

  16. Pathogen reduction and blood transfusion safety in Africa: strengths, limitations and challenges of implementation in low-resource settings.

    Science.gov (United States)

    Ware, A D; Jacquot, C; Tobian, A A R; Gehrie, E A; Ness, P M; Bloch, E M

    2018-01-01

    Transfusion-transmitted infection risk remains an enduring challenge to blood safety in Africa. A high background incidence and prevalence of the major transfusion-transmitted infections (TTIs), dependence on high-risk donors to meet demand, suboptimal testing and quality assurance collectively contribute to the increased risk. With few exceptions, donor testing is confined to serological evaluation of human immunodeficiency virus (HIV), hepatitis B and C (HBV and HCV) and syphilis. Barriers to implementation of broader molecular methods include cost, limited infrastructure and lack of technical expertise. Pathogen reduction (PR), a term used to describe a variety of methods (e.g. solvent detergent treatment or photochemical activation) that may be applied to blood following collection, offers the means to diminish the infectious potential of multiple pathogens simultaneously. This is effective against different classes of pathogen, including the major TTIs where laboratory screening is already implemented (e.g. HIV, HBV and HCV) as well pathogens that are widely endemic yet remain unaddressed (e.g. malaria, bacterial contamination). We sought to review the available and emerging PR techniques and their potential application to resource-constrained parts of Africa, focusing on the advantages and disadvantages of such technologies. PR has been slow to be adopted even in high-income countries, primarily given the high costs of use. Logistical considerations, particularly in low-resourced parts of Africa, also raise concerns about practicality. Nonetheless, PR offers a rational, innovative strategy to contend with TTIs; technologies in development may well present a viable complement or even alternative to targeted screening in the future. © 2017 International Society of Blood Transfusion.

  17. 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 initiative...... are very costly in relation to the benefit they offer. Although estimation of the cost-effectiveness requires detailed information about the survival of transfusion recipients, previous cost-effectiveness analyses have relied on incorrect survival assumptions....

  18. Accuracy and precision of four value-added blood glucose meters: the Abbott Optium, the DDI Prodigy, the HDI True Track, and the HypoGuard Assure Pro.

    Science.gov (United States)

    Sheffield, Catherine A; Kane, Michael P; Bakst, Gary; Busch, Robert S; Abelseth, Jill M; Hamilton, Robert A

    2009-09-01

    This study compared the accuracy and precision of four value-added glucose meters. Finger stick glucose measurements in diabetes patients were performed using the Abbott Diabetes Care (Alameda, CA) Optium, Diagnostic Devices, Inc. (Miami, FL) DDI Prodigy, Home Diagnostics, Inc. (Fort Lauderdale, FL) HDI True Track Smart System, and Arkray, USA (Minneapolis, MN) HypoGuard Assure Pro. Finger glucose measurements were compared with laboratory reference results. Accuracy was assessed by a Clarke error grid analysis (EGA), a Parkes EGA, and within 5%, 10%, 15%, and 20% of the laboratory value criteria (chi2 analysis). Meter precision was determined by calculating absolute mean differences in glucose values between duplicate samples (Kruskal-Wallis test). Finger sticks were obtained from 125 diabetes patients, of which 90.4% were Caucasian, 51.2% were female, 83.2% had type 2 diabetes, and average age of 59 years (SD 14 years). Mean venipuncture blood glucose was 151 mg/dL (SD +/-65 mg/dL; range, 58-474 mg/dL). Clinical accuracy by Clarke EGA was demonstrated in 94% of Optium, 82% of Prodigy, 61% of True Track, and 77% of the Assure Pro samples (P Abbott Optium was significantly more accurate than the other meter systems, whereas the HDI True Track was significantly less accurate and less precise compared to the other meter systems.

  19. Comparison of quality assurance for performance and safety characteristics of the facility for Boron Neutron Capture therapy in Petten/NL with medical electron accelerators

    International Nuclear Information System (INIS)

    Rassow, Juergen; Stecher-Rasmussen, Finn; Voorbraak, Wim; Moss, Ray; Vroegindeweij, Corine; Hideghety, Katalin; Sauerwein, Wolfgang

    2001-01-01

    Background and purpose: The European Council Directive on health protection 97/43/EURATOM requires radiotherapy quality assurance programmes for performance and safety characteristics including acceptance and repeated tests. For Boron Neutron Capture therapy (BNCT) at the High Flux Reactor (HFR) in Petten/NL such a programme has been developed on the basis of IEC publications for medical electron accelerators. Results: The fundamental differences of clinical dosimetry for medical electron accelerators and BNCT are presented and the order of magnitude of dose components and their stability and that of the main other influencing parameter 10 B concentration for BNCT patient treatments. A comparison is given for requirements for accelerators and BNCT units indicating items which are not transferable, equal or additional. Preliminary results of in vivo measurements done with a set of 55 Mn, 63 Cu and 197 Au activation foils for all single fields for the four fractions at all 15 treated patients show with <±4% up to now a worse reproducibility than the used dose monitoring systems (±1.5%) caused by influence of hair position on the foil-skull distance. Conclusions: Despite the more complex clinical dosimetry (because of four relevant dose components, partly of different linear energy transfer (LET)) BNCT can be regulated following the principles of quality assurance procedures for therapy with medical electron accelerators. The reproducibility of applied neutron fluence (proportional to absorbed doses) and the main safety aspects are equal for all teletherapy methods including BNCT

  20. Summary report of the Department of Energy, Division of Operational and Environmental Safety: Quality Assurance Programs 1 through 4

    International Nuclear Information System (INIS)

    Welford, G.A.; Fisenne, I.M.; Sanderson, C.

    1978-01-01

    Analytical Laboratories which provide environmental monitoring data for assessment of radioactive contamination, under the Department of Energy (DOE) Contract, were requested to participate in a Quality Assurance Program. The Environmental Measurements Laboratory (EML) was asked to prepare intercomparison samples for radionuclide analysis of soil, water, air filters, tissue ash, and vegetation ash for distribution to the Analytical Laboratories. Samples were collected in the environment of DOE facilities, since only water and air samples could be conveniently spiked. A set of 6 to 8 samples is distributed quarterly to about 28 laboratories. EML performed multiple analyses on the samples, however, the results are considered intercomparisons not standards. This report summarizes the program and evaluates the data for Quality Assurance Programs (QAP) from 1 through 4

  1. 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.)

  2. Economic Consequences of Mandated Grading and Food Safety Assurance: Ex Ante Analysis of the Federal Marketing Order

    OpenAIRE

    Gray, Richard; Sumner, Daniel A.; Alston, Julian M.; Brunke, Henrich; Acquaye, Albert K. A.

    2005-01-01

    The U.S. pistachio industry, located almost exclusively in California, has grown substantially over the past thirty years and now occupies an important and growing share of the world market. In recent years, a group of growers led an initiative to establish a federal marketing order, which will work to assure consistency in the quality of California pistachios and thereby increase consumer demand and confidence in the product and enhance producer returns. The marketing order, scheduled to tak...

  3. 76 FR 76732 - Nominations to the Advisory Committee on Blood Safety and Availability

    Science.gov (United States)

    2011-12-08

    ... individuals will be nominated to the Secretary of HHS for consideration of appointment as members of the ACBSA..., Associate Public Health Advisor for Blood, Organ and Tissue Safety Policy, Department of Health and Human.... Nominations In accordance with the charter, persons nominated for appointment as members of the ACBSA should...

  4. Health economics of blood transfusion safety - focus on sub-Saharan Africa

    NARCIS (Netherlands)

    van Hulst, Marinus; Smit Sibinga, Cees Th. Smit; Postma, Maarten J.

    Background and objectives. Health economics provides a standardised methodology for valid comparisons of interventions in different fields of health care. This review discusses the health economic evaluations of strategies to enhance blood product safety in sub-Saharan Africa Methods. We reviewed

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

    Science.gov (United States)

    Custer, Brian; Janssen, Mart P

    2015-08-01

    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 interventions. The objective of this review is to address key considerations and limitations of current methods as they apply to blood safety. Because a voluntary blood supply is an example of a public good, analyses should be conducted from the societal perspective when possible. Two primary study designs are recommended for most blood safety intervention assessments: budget impact analysis (BIA), which measures the cost to implement an intervention both to the blood operator but also in a broader context, and cost-utility analysis (CUA), which measures the ratio between costs and health gain achieved, in terms of reduced morbidity and mortality, by use of an intervention. These analyses often have important limitations because data that reflect specific aspects, for example, blood recipient population characteristics or complication rates, are not available. Sensitivity analyses play an important role. The impact of various uncertain factors can be studied conjointly in probabilistic sensitivity analyses. The use of BIA and CUA together provides a comprehensive assessment of the costs and benefits from implementing (or not) specific interventions. RBDM is multifaceted and impacts a broad spectrum of stakeholders. Gathering and analyzing health economic evidence as part of the RBDM process enhances the quality, completeness, and transparency of decision-making. © 2015 AABB.

  6. 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.

  7. 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.

  8. Quality-Assurance Program Plan

    International Nuclear Information System (INIS)

    Kettell, R.A.

    1981-05-01

    This Quality Assurance Program Plan (QAPP) is provided to describe the Quality Assurance Program which is applied to the waste management activities conducted by AESD-Nevada Operations at the E-MAD Facility located in Area 25 of the Nevada Test Site. The AESD-Nevada Operations QAPP provides the necessary systematic and administrative controls to assure activities that affect quality, safety, reliability, and maintainability during design, procurement, fabrication, inspection, shipments, tests, and storage are conducted in accordance with established requirements

  9. 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.

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

    International Nuclear Information System (INIS)

    Jung, Minhwan; Gam, Dayoung; Eoh, Jae-Hyuk; Jeong, Ji-Young

    2015-01-01

    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

  11. 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

    International Nuclear Information System (INIS)

    Booth, R.S.; Kryter, R.C.; Shepard, R.L.; Smith, O.L.; Upadhyaya, B.R.; 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

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

    DEFF Research Database (Denmark)

    Njage, Patrick Murigu Kamau; Sawe, Chemutai Tonui; Onyango, Cecilia Moraa

    2017-01-01

    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...... 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...... 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...

  13. Up-to-date laboratory methods for assessing the safety of perfumery and cosmetic products in the quality assurance system of the Russian Federation

    Directory of Open Access Journals (Sweden)

    A. V. Rezaykina

    2016-01-01

    Full Text Available Most of the developed countries as well as Russian Federation have a dynamically developing quality assurance system for testing the quality of laboratory tests and safety of perfumery and cosmetic products entering the market comprising a regulatory and legal framework, physical infrastructure and appropriate methodical basis and staff. At the same time, it is necessary to develop alternative test methods adjusted to perfumery and cosmetic products on a regular basis. In addition, it is necessary to optimize methods for ensuring standard sample preparation conditions in response to new forms of cosmetic products when determining microbiological, physical, chemical and toxicological characteristics, and more accurate observation methods for clinical and laboratory indices to be approved by supervising authorities.

  14. Quality assurance

    International Nuclear Information System (INIS)

    Cante; Feger; Genevray; Hennion; Moneyron; Monneyron; Normand; Rastoin; Silberstein; Vaujour.

    1976-01-01

    The general principles of quality assurance and their applications within the French industrial and commercial regulations are presented. The conditions for the practical application of quality assurance to the different stages of the life of a nuclear power station (design, development, operation) are considered and a special mention is made of nuclear fuels and liquid sodium cooled reactors [fr

  15. Health economics of blood transfusion safety--focus on sub-Saharan Africa.

    Science.gov (United States)

    van Hulst, Marinus; Smit Sibinga, Cees Th; Postma, Maarten J

    2010-01-01

    Health economics provides a standardised methodology for valid comparisons of interventions in different fields of health care. This review discusses the health economic evaluations of strategies to enhance blood product safety in sub-Saharan Africa. We reviewed health economic methodology with special reference to cost-effectiveness analysis. We searched the literature for cost-effectiveness in blood product safety in sub-Saharan Africa. HIV-antibody screening in different settings in sub-Saharan Africa showed health gains and saved costs. Except for adding HIV-p24 screening, adding other tests such as nucleic acid amplification testing (NAT) to HIV-antibody screening displayed incremental cost-effectiveness ratios greater than the WHO/World Bank specified threshold for cost-effectiveness. The addition of HIV-p24 in combination with HCV antibody/antigen screening and multiplex (HBV, HCV and HIV) NAT in pools of 24 may also be cost-effective options for Ghana. From a health economic viewpoint, HIV-antibody screening should always be implemented in sub-Saharan Africa. The addition of HIV-p24 antigen screening, in combination with HCV antibody/antigen screening and multiplex (HBV, HCV and HIV) NAT in pools of 24 may be feasible options for Ghana. Suggestions for future health economic evaluations of blood transfusion safety interventions in sub-Saharan Africa are: mis-transfusion, laboratory quality and donor management. Copyright 2009 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.

  16. Overview of clinical efficacy and safety of pharmacologic strategies for blood conservation.

    Science.gov (United States)

    Levy, Jerrold H

    2005-09-15

    The pharmacologic management of hemostasis in patients undergoing surgery with cardiopulmonary bypass is discussed. Nearly 45 studies involving 7,000 patients have reported efficacy of aprotinin in blood conservation. Both in primary coronary artery bypass graft (CABG) surgeries and in repeat surgeries, aprotinin treatment significantly reduces the incidence of blood transfusions and the number of units of blood transfused. These effects have been observed for red blood cell, platelet, and other blood products. The safety of aprotinin treatment has been extensively evaluated in randomized clinical trials, in postmarketing databases, and in systematic reviews of the literature. Overall, data do not indicate that aprotinin treatment increases mortality, myocardial infarction, or renal failure. These findings are supported by the results of a recent meta-analysis of 35 studies in patients undergoing CABG surgery. In addition, the meta-analysis suggests that aprotinin treatment was associated with a reduced incidence of stroke and a trend toward a reduced incidence of atrial fibrillation. Although lysine analogs, desmopressin, and recombinant factor VIIa are sometimes used to reduce bleeding, only aprotinin is indicated for use during CABG surgery. The future of cardiac surgery will be marked by an increasingly complex, high-risk group of patients and a greater need for multiple pharmacologic options for reducing bleeding. Pharmacologic approaches that attenuate the activation of the hemostatic system and inflammation need to be employed to decrease coagulopathies and the need for allogeneic blood administration.

  17. Quality assurance

    International Nuclear Information System (INIS)

    1996-01-01

    The main efforts of Nuclear Regulatory Authority of the Slovak Republic (NRA SR) was focused on support of quality assurance programmes development at responsible organizations Bohunice V-1 and V-v and Mochovce NPPs and their inspection. Development of the level two documentation of a partial quality assurance programme for NPP operation continued at Mochovce NPP. Most of documentation has been submitted to NRA SR for comments and approval. NRA SR invited a mission of French experts to Mochovce NPP to review preparation and performance of internal audits that would be beneficial for improvement in this kind activities at the NPP. Bohunice NPP continued in development of a partial quality assurance programme for operation. The Quality Assurance Programme submitted to NRA SR for approval. Based on a request of Bohunice NPPs, NRA SR consulted the draft quality assurance programme developed by Siemens for stage of the 'Basic Design' of V-1 NPP upgrading. The programme had not been submitted for approval to NRA SR prior to completion of works by Siemens. Based on an internal audit that had been performed, corrective measures were proposed to meet requirements on review and approval of suppliers quality assurance programmes. Requirements related to the quality assurance at nuclear installations were prepared to be incorporated into principles of a act on peaceful use of nuclear power in Slovak Republic

  18. 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.

  19. Physical aspects of quality assurance in nuclear medicine and radiotherapy, regulatory approach of the National Nuclear Safety Center

    International Nuclear Information System (INIS)

    Gonzalez C, D.; Fuente P, A. de la; Quevedo G, J.R.; Lopez F, Y.; Varela C, C.

    2006-01-01

    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

  20. 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...

  1. Quality assurance

    OpenAIRE

    Cauchi, Maurice A.M.

    1993-01-01

    The concept of quality assurance refers more specifically to the process of objectifying and clearly enunciating goals, and providing means of assessing the outcomes. In this article the author mentions four fundamental elements of quality assurance which should be applied in the medical profession in Malta. These elements should relate to professional performance, resource utilisation, risk management and patient satisfaction. The aim of the medical professionals in Malta is to provide the b...

  2. 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.

  3. 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.

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

    International Nuclear Information System (INIS)

    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

  5. 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.

  6. Nova laser assurance-management system

    International Nuclear Information System (INIS)

    Levy, A.J.

    1983-01-01

    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

  7. 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.

  8. Financial assurances

    International Nuclear Information System (INIS)

    Paton, R.F.

    1990-01-01

    US Ecology is a full service waste management company. The company operates two of the nation's three existing low-level radioactive waste (LLRW) disposal facilities and has prepared and submitted license applications for two new LLRW disposal facilities in California and Nebraska. The issue of financial assurances is an important aspect of site development and operation. Proper financial assurances help to insure that uninterrupted operation, closure and monitoring of a facility will be maintained throughout the project's life. Unfortunately, this aspect of licensing is not like others where you can gauge acceptance by examining approved computer codes, site performance standards or applying specific technical formulas. There is not a standard financial assurance plan. Each site should develop its requirements based upon the conditions of the site, type of design, existing state or federal controls, and realistic assessments of future financial needs. Financial assurances at U.S. Ecology's existing sites in Richland, Washington, and Beatty, Nevada, have been in place for several years and are accomplished in a variety of ways by the use of corporate guarantees, corporate capital funds, third party liability insurance, and post closure/long-term care funds. In addressing financial assurances, one can divide the issue into three areas: Site development/operations, third party damages, and long-term care/cleanup

  9. Quality and safety of herbal medical products: regulation and the need for quality assurance along the value chains.

    Science.gov (United States)

    Heinrich, Michael

    2015-07-01

    Herbal medicines and products derived from them are a diverse group of products for which different (and often limited) levels of evidence are available. As importantly, such products generally vary in their composition and are at the end of an often poorly understood value chain, which often links producers in biodiversity rich countries with the large markets in the North. This paper discusses the current regulatory framework of such herbal medical products (with a focus on the UK) and using examples from our own metabolomic research on Curcumal longa L. (turmeric, Zingiberaceae) how value chains impact on the composition and quality (and thus the safety) of such products. Overall, our recent research demonstrates the need for studying the links between producers and consumers of commodities produced in provider countries and that plant metabolomics offer a novel way of assessing the chemical variability along a value chain. © 2015 The British Pharmacological Society.

  10. Computational methods assuring nuclear power plant structural integrity and safety: an overview of the recent activities at VTT

    International Nuclear Information System (INIS)

    Keinaenen, H.; Talja, H.; Rintamaa, R.

    1998-01-01

    Numerical, simplified engineering and standardised methods are applied in the safety analyses of primary circuit components and reactor pressure vessels. The integrity assessment procedures require input relating both to the steady state and transient loading actual material properties data and precise knowledge of the size and geometry of defects. Current procedures bold extensive information regarding these aspects. It is important to verify the accuracy of the different assessment methods especially in the case of complex structures and loading. The focus of this paper is on the recent results and development of computational fracture assessment methods at VTT Manufacturing Technology. The methods include effective engineering type tools for rapid structural integrity assessments and more sophisticated finite-element based methods. An integrated PC-based program system MASI for engineering fracture analysis is described. A summary of the verification of the methods in computational benchmark analyses and against the results of large scale experiments is presented. (orig.)

  11. 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.

  12. Achievement report on research and development in the Sunshine Project in fiscal 1977. Studies on hydrogen energy total systems and the safety assuring technologies thereon (Studies on preparing criteria for the safety assuring technologies for hydrogen energy total systems); 1977 nendo suiso energy total system to sono hoan gijutsu ni kansuru kenkyu seika hokokusho. Suiso energy total system no hoan gijutsu kijun no sakusei ni kansuru kenkyu

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1978-03-01

    Studies have been made on preparing criteria for the safety assuring technologies for hydrogen energy total systems. The outline of the technological guideline for hydrogen manufacturing processes in the high temperature and pressure water decomposition method is the same as that in the normal pressure water decomposition method. However, its high temperature and pressure environment can cause new safety problems. Considerations should be given on, for example, material problems in structural materials and insulation materials including electrodes and membranes, introduction of gas-liquid separation and pressure balancing devices, problems in electrolyte circulation, and safety problems that may occur because of generation of hydrogen and oxygen under high temperature and pressure conditions. This paper summarizes these matters by surveying literature data. In order to provide basic information to prepare criteria for safety assuring technologies for the gaseous hydrogen liquefaction process, surveys and studies were made based on different items of technological information and experimental study results. Safety assuring technologies were discussed on metal hydrides (promising means for storing hydrogen). Powder is used to enhance hydrogen absorbing performance, whereas the metal hydrides are pulverized as a result of repetition of absorption and discharge of hydrogen. This paper describes also metal dust explosion disaster and its risk of occurrence. (NEDO)

  13. Quality assurance in nuclear power plant

    International Nuclear Information System (INIS)

    Magalhaes, M.T. de

    1981-01-01

    The factors related to the licensing procedures of a nuclear power plant (quality assurance and safety analysis) are presented and discussed. The consequences of inadequate attitudes towards these factors are shown and suggestions to assure the safety of nuclear power plants in Brazil are presented. (E.G.) [pt

  14. Introduction to quality assurance

    International Nuclear Information System (INIS)

    Raisic, N.

    1980-01-01

    Safety requirements set forth in the regulatory requirement, codes, standards as well as other requirements for various aspects of nuclear power plant design and operation are strictly implemented through QA activities. The overall QA aim is to assure that the plant is soundly and correctly designed and that it is built, tested and operated in accordance with stringent quality standards and conservative engineering practices. In this way a high degree of freedom from faults and errors can be achieved. (orig.)

  15. Probability of Loss of Assured Safety in Systems with Multiple Time-Dependent Failure Modes: Incorporation of Delayed Link Failure in the Presence of Aleatory Uncertainty.

    Energy Technology Data Exchange (ETDEWEB)

    Helton, Jon C. [Arizona State Univ., Tempe, AZ (United States); Brooks, Dusty Marie [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Sallaberry, Cedric Jean-Marie. [Engineering Mechanics Corp. of Columbus, OH (United States)

    2018-02-01

    Probability of loss of assured safety (PLOAS) is modeled for weak link (WL)/strong link (SL) systems in which one or more WLs or SLs could potentially degrade into a precursor condition to link failure that will be followed by an actual failure after some amount of elapsed time. The following topics are considered: (i) Definition of precursor occurrence time cumulative distribution functions (CDFs) for individual WLs and SLs, (ii) Formal representation of PLOAS with constant delay times, (iii) Approximation and illustration of PLOAS with constant delay times, (iv) Formal representation of PLOAS with aleatory uncertainty in delay times, (v) Approximation and illustration of PLOAS with aleatory uncertainty in delay times, (vi) Formal representation of PLOAS with delay times defined by functions of link properties at occurrence times for failure precursors, (vii) Approximation and illustration of PLOAS with delay times defined by functions of link properties at occurrence times for failure precursors, and (viii) Procedures for the verification of PLOAS calculations for the three indicated definitions of delayed link failure.

  16. Priority needs and wisdom strategy for blood transfusion safety in developing low-resource countries.

    Science.gov (United States)

    Abdelrazik, Abeer Mohamed; Ezzat Ahmed, Ghada M

    2016-02-01

    To evaluate the implementation of alternative safety measures that reduce the risk of transfusion transmissible infections as an affordable measure in low resource countries. It is still difficult in developing countries with limited resources to mandate nucleic acid testing due to its high cost. Although NAT reduces the window period of infection, the developing countries are still in need of an efficient and effective transfusion programme before implementing the complex high cost NAT. Two thousand eight hundred eighty sero-negative first-time and repeat donations from Fayoum University Hospital blood bank were individually analysed by NAT for HIV, HBV and HCV. Only discriminatory-positive NAT were classified comparing the non-remunerated and family replacement donations. Significant discriminatory-positive differences were observed for HBV NAT results, 2 remunerated donations compared to 0 non-remunerated sero-negative donations. The discriminatory positive differences were also significant for HCV NAT results, 4 remunerated donations compared to 1 non-remunerated sero-negative donation. No sero-negative, discriminatory-positive NAT HIV case was found. Seven out of 8 discriminatory positive cases were from first time donations. In order to ensure blood safety, the recruitment and retention of voluntary, non-remunerated repeat donors should be a major commitment for low resource countries in which NAT implementation is costly and not feasible. Copyright © 2016 Elsevier Ltd. All rights reserved.

  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. 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.

  19. 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.

  20. Quality assurance

    International Nuclear Information System (INIS)

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

    1995-01-01

    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

  1. Quality assurance within regulatory bodies

    International Nuclear Information System (INIS)

    1999-06-01

    The IAEA directed extensive efforts during the years 1991 to 1995 to the integral revision of all NUSS quality assurance publications, which were approved and issued as Safety Series No.50-C/SG-Q, Quality Assurance for Safety in Nuclear Power Plants and other Nuclear Installations (1996). When these quality assurance publications were developed, their prime focus was on requirements against which work performed by the licensees could be measured and assessed by the regulatory bodies. In this way, they only helped to facilitate the functions of regulators. No requirements or recommendations were provided on how the regulators should ensure the effective implementation of their own activities. The present publication is a first attempt to collect, integrate and offer available experience to directly support performance of regulatory activities. It presents a comprehensive compilation on the application of quality assurance principles and methods by regulatory bodies to their activities. The aim is consistent good performance of regulatory activities through a systematic approach

  2. Quality assurance records system

    International Nuclear Information System (INIS)

    1979-01-01

    This Safety Guide was prepared as part of the Agency's programme, referred to as the NUSS programme, for establishing Codes of Practice and Safety Guides relating to nuclear power plants. It supplements the IAEA Code of Practice on Quality Assurance for Safety in Nuclear Power Plants (IAEA Safety Series No.50-C-QA), which requires that for each nuclear power plant a system for the generation, identification, collection, indexing, filing, storing, maintenance and disposition of quality assurance records shall be established and executed in accordance with written procedures and instructions. The purpose of this Safety Guide is to provide assistance in the establishment and operation of such a system. An orderly established and maintained records system is considered to be part of the means of providing a basis for an appropriate level of confidence that the activities which affect the quality of a nuclear power plant have been performed in accordance with the specific requirements and that the required quality has been achieved and is maintained

  3. Efficacy and safety of intravenous iron therapy as an alternative/adjunct to allogeneic blood transfusion.

    Science.gov (United States)

    Muñoz, M; Breymann, C; García-Erce, J A; Gómez-Ramírez, S; Comin, J; Bisbe, E

    2008-04-01

    Anaemia is a common condition among patients admitted to hospital medicosurgical departments, as well as in critically ill patients. Anaemia is more frequently due to absolute iron deficiency (e.g. chronic blood loss) or functional iron deficiency (e.g. chronic inflammatory states), with other causes being less frequent. In addition, preoperative anaemia is one of the major predictive factors for perioperative blood transfusion. In surgical patients, postoperative anaemia is mainly caused by perioperative blood loss, and it might be aggravated by inflammation-induced inhibition of erythropoietin and functional iron deficiency (a condition that cannot be corrected by the administration of oral iron). All these mechanisms may be involved in the anaemia of the critically ill. Intravenous iron administration seems to be safe, as very few severe side-effects were observed, and may result in hastened recovery from anaemia and lower transfusion requirements. However, it is noteworthy that many of the recommendations given for intravenous iron treatment are not supported by a high level of evidence and this must be borne in mind when making decisions regarding its application to a particular patient. Nonetheless, this also indicates the need for further large, randomized controlled trials on the safety and efficacy of intravenous iron for the treatment of anaemia in different clinical settings.

  4. RFID in the blood supply chain--increasing productivity, quality and patient safety.

    Science.gov (United States)

    Briggs, Lynne; Davis, Rodeina; Gutierrez, Alfonso; Kopetsky, Matthew; Young, Kassandra; Veeramani, Raj

    2009-01-01

    As part of an overall design of a new, standardized RFID-enabled blood transfusion medicine supply chain, an assessment was conducted for two hospitals: the University of Iowa Hospital and Clinics (UIHC) and Mississippi Baptist Health System (MBHS). The main objectives of the study were to assess RFID technological and economic feasibility, along with possible impacts to productivity, quality and patient safety. A step-by-step process analysis focused on the factors contributing to process "pain points" (errors, inefficiency, product losses). A process re-engineering exercise produced blueprints of RFID-enabled processes to alleviate or eliminate those pain-points. In addition, an innovative model quantifying the potential reduction in adverse patient effects as a result of RFID implementation was created, allowing improvement initiatives to focus on process areas with the greatest potential impact to patient safety. The study concluded that it is feasible to implement RFID-enabled processes, with tangible improvements to productivity and safety expected. Based on a comprehensive cost/benefit model, it is estimated for a large hospital (UIHC) to recover investment from implementation within two to three years, while smaller hospitals may need longer to realize ROI. More importantly, the study estimated that RFID technology could reduce morbidity and mortality effects substantially among patients receiving transfusions.

  5. Addressing safety liabilities of TfR bispecific antibodies that cross the blood-brain barrier.

    Science.gov (United States)

    Couch, Jessica A; Yu, Y Joy; Zhang, Yin; Tarrant, Jacqueline M; Fuji, Reina N; Meilandt, William J; Solanoy, Hilda; Tong, Raymond K; Hoyte, Kwame; Luk, Wilman; Lu, Yanmei; Gadkar, Kapil; Prabhu, Saileta; Ordonia, Benjamin A; Nguyen, Quyen; Lin, Yuwen; Lin, Zhonghua; Balazs, Mercedesz; Scearce-Levie, Kimberly; Ernst, James A; Dennis, Mark S; Watts, Ryan J

    2013-05-01

    Bispecific antibodies using the transferrin receptor (TfR) have shown promise for boosting antibody uptake in brain. Nevertheless, there are limited data on the therapeutic properties including safety liabilities that will enable successful development of TfR-based therapeutics. We evaluate TfR/BACE1 bispecific antibody variants in mouse and show that reducing TfR binding affinity improves not only brain uptake but also peripheral exposure and the safety profile of these antibodies. We identify and seek to address liabilities of targeting TfR with antibodies, namely, acute clinical signs and decreased circulating reticulocytes observed after dosing. By eliminating Fc effector function, we ameliorated the acute clinical signs and partially rescued a reduction in reticulocytes. Furthermore, we show that complement mediates a residual decrease in reticulocytes observed after Fc effector function is eliminated. These data raise important safety concerns and potential mitigation strategies for the development of TfR-based therapies that are designed to cross the blood-brain barrier.

  6. Quality assurance in radiotherapy

    International Nuclear Information System (INIS)

    2003-03-01

    Good radiotherapy results and safety of treatment require the radiation to be optimally applied to a specified target area and the correct dose. According to international recommendations, the average uncertainty in therapeutic dose should not exceed 5%. The need for high precision in therapeutic dose requires quality assurance covering the entire radiotherapy process. Besides the physical and technical characteristics of the therapy equipment, quality assurance must include all radiotherapy equipment and procedures that are significant for the correct magnitude and precision of application of the therapeutic dose. The duties and responsibilities pertaining to various stages of treatment must also be precisely defined. These requirements may be best implemented through a quality system. The general requirements for supervision and quality assurance of medical radiation apparatus are prescribed in section 40 of the Radiation Act (592/1991, amendment 1142/1998) and in sections 18 and 32 of the Decree of the Ministry of Social Affairs and Health on the medical use of radiation (423/2000). Guide ST 2.2 imposes requirements on structural radiation shielding of radiotherapy equipment and the premises in which it is used, and on warning and safety arrangements. Guide ST 1.1 sets out the general safety principles for radiation practices and regulatory control procedure for the use of radiation. Guide ST 1.6 provides general requirements for operational measures in the use of radiation. This Guide sets out the duties of responsible parties (the party running a radiation practice) in respect of arranging and maintaining radiotherapy quality assurance. The principles set out in this Guide and Guide ST 6.3 may be applied to radionuclide therapy

  7. 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

  8. Qualtity assurance in nuclear technology

    International Nuclear Information System (INIS)

    Roesler, U.

    1977-01-01

    The demand for safety in nuclear power plants is rooted in the Atomic Energy Act of the Federal Republic of Germany, under which 'preplanned safety' is a licensing condition. Moreover, the safety of nuclear power plants is outlined in more precise terms in the guidelines of the German Advisory Committee for Reactor Safeguards (Reaktorsicherheitskommission). The usual approach taken in this country, i.e., to establish quality assurance for each specific product, with supplementary quality assurance measures geared to systems requirements being implemented by industry, has proved to work satisfactorily. Product-based quality assurance mainly stems from the classical quality control concept, whereas systems-based quality assurance primarily is to ensure that both manufacturers and systems suppliers take all measures in advance which are needed for the satisfactory processing of an order and to achieve the quality level required. The special features and the advantages of the joint action of manufacturers, systems suppliers and experts, which are characteristic of the German approach, very clearly emerge from a comparison with practices in the United States. In the further refinement of the quality assurance concept as practised in Germany, qhich will have a particularly great impact on costs and schedules because of the manpower requirement involved, it should be carefully weighed where there are exaggerations and unnecessary complications which can no longer be justified by the demand for more safety. (orig.) [de

  9. Occurrence of lead-related symptoms below the current occupational safety and health act allowable blood lead levels.

    Science.gov (United States)

    Rosenman, Kenneth D; Sims, Amy; Luo, Zhehui; Gardiner, Joseph

    2003-05-01

    To determine the occurrence of symptoms of lead toxicity at levels below the current allowable Occupational Safety and Health Act blood lead level of 50 micrograms/dL, standardized telephone interviews were conducted of individuals reported to a statewide laboratory-based surveillance system. Four hundred and ninety-seven, or 75%, of the eligible participants were interviewed. Gastrointestinal, musculoskeletal, and nervous system symptoms increased with increasing blood lead levels. Nervous, gastrointestinal, and musculoskeletal symptoms all began to be increased in individuals with blood leads between 30-39 micrograms/dL and possibly at levels as low as 25-30 micrograms/dL for nervous system symptoms. The results of this study of increased symptoms are consistent with and provide added weight to previous results showing subclinical changes in the neurologic and renal systems and sperm counts at blood lead levels currently allowed by the Occupational Safety and Health Act.

  10. 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.

  11. Quality assurance

    International Nuclear Information System (INIS)

    Hiller, G.H.

    1979-01-01

    This compendium intends to give fast bibliographic information and to fill the visible gap between documentation and general bibliographic information. The reader is given an outline of quality assurance and some examples of techniques from the relevant literature. The practical engineer, who is always short of time, is thus offered a quick survey and a fast deepening of his understanding by means of literature dealing specifically with his unresolved problems. The mansucript has been kept in tis original form in order to speed up tis publication. The RKW technical department limited itself to checking its contents and the adherence to the established information goals. (orig.) 891 RW/orig. 892 MB [de

  12. Chapter 8: Quality assurance

    International Nuclear Information System (INIS)

    2001-01-01

    The main efforts of Nuclear Regulatory Authority of the Slovak Republic (UJD) have been focused on inspection of quality assurance programmes of Slovak Power Stations, plc. and its daughter companies at Bohunice and Mochovce. Two quality assurance inspections in the area of periodical in service inspections (V-2 units) and tests of selected equipment (NPP V-2 units) and operation control (V-1 units) has been performed at NPPs Bohunice. One violation of decree on quality assurance of selected equipment has been found in the area of documentation archiving. The inspection concerning the implementation of quality assurance programme for operation of NPP Mochovce in the area of operation control has been performed focused on safety aspects of operation, operational procedures, control of operational events and feedback from operational experience. The results of this inspection were positive. Inspection of implementation of quality assurance programme for operation of radioactive waste repository (RU RAW) at the Mochovce location has been performed focused on receiving of containers, with radioactive wastes, containers handling, radiation monitoring, activities of documentation control and radiation protection at the repository site. No serious deficiencies have been found out. Also one inspection of experimental nuclear installations of VUJE Trnava at Jaslovske Bohunice site has been performed focused on procurement control, quality audits, documentation and quality records control when performing activities at experimental nuclear installations. The activity on development of internal quality assurance system continued. The implementation of this system will assure quality and effective fulfilment enlarged tasks of UJD with limited resources for its activity. The analyses of possible use of existing internal administrative control documentation as a basis for future quality system procedures was performed in co-operation with an external specialised organisation. The

  13. Quality assurance during site construction

    International Nuclear Information System (INIS)

    Dommke, J.; Jurgutat, H.

    1980-01-01

    During the time of planing and construction of a nuclear power plant, the following proceeding is approved: - the deliverer of a nuclear power plant provides the reports fixing the quality assurance program, it means that he is responsible to write the safety analysis report, the specifications for the erection of the components, the working manuals and specifications for testing (eg nondestr. testing) - the manufacturing of components or systems will be controlled by an own independent quality assurance group, provided that this group was checked by the quality assurance group of the applicant - the TUeV with its independent assessors will fix the requirements relating to quality assurance in its assessment. On this basis the examination of the applicants specifications, working manuals, testing specifications will be done. The efficiency of quality assurance at the manufacturer and at the applicant will be checked by the TUeV specialists by considering specifications of modifications, repairs or tolerances. A mean point of the quality assurance in Germany is the dynamic adjustment, of an action on the latest state of engineering or science. If there exists a change of rules or guidelines, the quality assurance requirements have to be fit on this state in so far as it is feasible from the technical point of view. (orig./RW)

  14. Safety and effects of two red blood cell transfusion strategies in pediatric cardiac surgery patients: a randomized controlled trial

    NARCIS (Netherlands)

    de Gast-Bakker, D. H.; de Wilde, R. B. P.; Hazekamp, M. G.; Sojak, V.; Zwaginga, J. J.; Wolterbeek, R.; de Jonge, E.; Gesink-van der Veer, B. J.

    2013-01-01

    To investigate the safety and effects of a restrictive red blood cell (RBC) transfusion strategy in pediatric cardiac surgery patients. Randomized controlled trial. Pediatric ICU in an academic tertiary care center, Leiden University Medical Center, Leiden, The Netherlands. One hundred seven

  15. Quality assurance program

    International Nuclear Information System (INIS)

    1977-07-01

    This topical report describes the Gibbs and Hill Quality Assurance Program and sets forth the methods to be followed in controlling quality-related activities performed by Gibbs and Hill and its contractors. The program is based on company experience in nuclear power and related work, and defines a system found effective in providing independent control of quality-related functions and documentation. The scope of the report covers activities involving nuclear safety-related structures, systems, and components covered by Gibbs and Hill' contractual obligation to the Utility Owner for each project

  16. Grading of quality assurance requirements

    International Nuclear Information System (INIS)

    1991-01-01

    The present Manual provides guidance and illustrative examples for applying a method by which graded quality assurance requirements may be determined and adapted to the items and services of a nuclear power plant in conformance with the requirements of the IAEA Nuclear Safety Standards (NUSS) Code and Safety Guides on quality assurance. The Manual replaces the previous publication IAEA-TECDOC-303 on the same subject. Various methods of grading quality assurance are available in a number of Member States. During the development of the present Manual it was not considered practical to attempt to resolve the differences between those methods and it was preferred to identify and benefit from the good practices available in all the methods. The method presented in this Manual deals with the aspects of management, documentation, control, verification and administration which affect quality. 1 fig., 4 tabs

  17. Establishment of a rationalized safety assurance logic aiming at FBRs with enhanced social acceptance (1). Interim report of CEA/JNC collaboration NWP-5(a) from 1999 to 2001: common view and JNC's contribution

    International Nuclear Information System (INIS)

    Niwa, Hajime; Tobita, Yoshiharu; Kurisaka, Kenichi; Kubo, Shigenobu; Kamiyama, Kenji

    2001-12-01

    This is an interim report describing the progress and the results of the collaborative research works between JNC and CEA on the safety logic in future fast reactors under the title of 'Establishment of a Rationalized Safety Assurance Logic Aiming at FBRs with Enhanced Social Acceptance' from 1999 to 2001. This contains JNC's contribution and common view of both partners. (1) Safety goals are proposed from JNC and CEA. Significant coherency is found such as to keep defense-in depth concept, mitigation measures against core melt are taken into account for containment design, evacuation free' concept is pursued, quantitative safety target is also considered as well as deterministic approach, and improvement of social acceptance is considered from the development stage of the fuel cycle including nuclear power plants. (2) Safety characteristics of each candidate coolant were compared and discussed. Gas-cooled fast reactor is a common interest area. Discussions are focused on: safety design requirements, safety evaluation events list, transient behavior analysis, core catcher designs, and so on. (3) JNC's results include criticality map for predicting CDA behavior and consequences, and CDA analysis results of lead-cooled and gas-cooled fast reactors with SIMMER-III. The collaboration on the action NWP-5a is recognized as being of great importance for the orientation of the innovative design studies. (author)

  18. Quality assurance plan, Westinghouse Water Reactor Divisions

    Energy Technology Data Exchange (ETDEWEB)

    1976-03-01

    The Quality Assurance Program used by Westinghouse Nuclear Energy Systems Water Reactor Divisions is described. The purpose of the program is to assure that the design, materials, and workmanship on Nuclear Steam Supply System (NSSS) equipment meet applicable safety requirements, fulfill the requirements of the contracts with the applicants, and satisfy the applicable codes, standards, and regulatory requirements.

  19. 30 CFR 7.7 - Quality assurance.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality assurance. 7.7 Section 7.7 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY General § 7.7 Quality assurance. Applicants granted...

  20. 30 CFR 15.8 - Quality assurance.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality assurance. 15.8 Section 15.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... § 15.8 Quality assurance. (a) Applicants granted an approval or an extension of approval under this...

  1. Design quality assurance for nuclear power plants

    International Nuclear Information System (INIS)

    1986-07-01

    This Standard contains the requirements for the quality assurance program applicable to the design phase of a nuclear plant, and is applicable to the design of safety-related equipment, systems, and structures, as identified by the owner. 1 fig

  2. Design quality assurance for nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1986-07-01

    This Standard contains the requirements for the quality assurance program applicable to the design phase of a nuclear plant, and is applicable to the design of safety-related equipment, systems, and structures, as identified by the owner. 1 fig.

  3. Concepts of nuclear quality assurance

    International Nuclear Information System (INIS)

    Randers, G.; Morris, P.A.; Pomeroy, D.

    1976-01-01

    While the safety record of the nuclear industry continues to be excellent, the forced outage rates for recent years continue to be 15% or more. Quality assurance, therefore, needs to be applied not only to nuclear safety matters, but to the goals of increased productivity and reduced construction and operating costs. Broadening the application of the general concept of quality assurance in this way leads to the introduction of reliability technology. The total activity might better be called reliability assurance. That effective quality assurance systems do pay off is described by examples from the utility industry, from a manufacturer of instruments and systems and from the experience of Westinghouse Electric Company's manufacturing divisions. The special situation of applying quality assurance to nuclear fuel is discussed. Problems include the lack of a fully developed regulatory policy in this area, incomplete understanding of the mechanism for pellet-clad interaction failures, incomplete access to manufacturers design and process information, inability to make desirable changes on a timely basis and inadequate feedback of irradiation experience. (author)

  4. Quality assurance in plant engineering

    International Nuclear Information System (INIS)

    Ohsumi, Morimichi

    1977-01-01

    Quality assurance is defined as the intentional and systematic activity carried out to obtain such reliability that the functions of nuclear power generating plants are demonstrated during the plant operation, and the section in charge has the role to organize, adjust and communicate so that the related sections can work smoothly. There are many documents concerning the quality assurance, such as quality assurance basic program, quality assurance manual, quality control plan and its manual and many specifications, etc. The content of the quality assurance is different for every step of plant planning such as at inquiry and order receiving, and prior to manufacturing, for example, inspection specification being decided for the material and the welded parts of classified pipings at the step of order receiving. Document management, engineering schedule and the custody of quality records are also quality assurance activities. Design management is controlled step by step; plant planning including safety analysis, overall layout plan, conceptual design of buildings, aseismatic design guide, heat balance and so on, system design mainly with system description, piping design including piping specification, standard dimensions of edge preparation, piping and valve lists, inspection manual, etc., detailed design, standardization of piping and design review, etc. are explained. The management of the intermediate between soft and hard parts consists of the quality check for material manufacturers and shipment inspection, etc. (Nakai, Y.)

  5. Quality assurance program plan for Building 324

    International Nuclear Information System (INIS)

    Tanke, J.M.

    1997-01-01

    This Quality Assurance Program Plan (QAPP) provides an overview of the quality assurance program for Building 324. This plan supersedes the PNNL Nuclear Facilities Quality Management System Description, PNL-NF-QMSD, Revision 2, dated March 1996. The program applies to the facility safety structures, systems, and components and to activities that could affect safety structures, systems, and components. Adherence to the quality assurance program ensures the following: US Department of Energy missions and objectives are effectively accomplished; Products and services are safe, reliable, and meet or exceed the requirements and expectations of the user; Hazards to the public, to Hanford Site and facility workers, and to the environment are minimized. The format of this Quality Assurance Program Plan is structured to parallel that of 10 CFR 83 0.120, Quality Assurance Requirements

  6. Quality assurance considerations in nuclear waste management

    International Nuclear Information System (INIS)

    Delvin, W.L.

    1982-01-01

    Proper use of quality assurance will provide the basis for an effective management control system for nuclear waste management programs. Control is essential for achieving successful programs free from costly losses and failures and for assuring the public and regulators that the environment and health and safety are being protected. The essence of quality assurance is the conscientious use of planned and systematic actions, based on selecting and applying appropriate requirements from an established quality assurance standard. Developing a quality assurance program consists of using knowledge of the technical and managerial aspects of a project to identify and evaluate risks of loss and failure and then to select appropriate quality assurance requirements that will minimize the risks. Those requirements are integrated into the project planning documents and are carried out as specific actions during the life of the project

  7. Quality assurance systems at SKODA JS

    International Nuclear Information System (INIS)

    Janecek, P.

    2000-01-01

    In addition to technical requirements put upon the design, manufacture, installation and commissioning of equipment for nuclear power plants, emphasis is laid upon quality assurance of such activities so as to secure nuclear safety of installations over the world. As the technical level of nuclear safety assurance is being enhanced continuously, the requirements are becoming more and more stringent, which is mirrored by the relevant standards and legislation. SKODA JS has always been pursuing the quality goal and has been contributing to this aspect markedly. The quality assurance system at SKODA JS helps the company to satisfy all the appropriate requirements of its customers as well as the applicable standards and regulations. (author)

  8. Westinghouse Water Reactor Divisions quality assurance plan

    International Nuclear Information System (INIS)

    1977-09-01

    The Quality Assurance Program used by Westinghouse Water Reactor Divisions is described. The purpose of the program is to assure that the design, materials, and workmanship on Nuclear Steam Supply System (NSSS) equipment meet applicable safety requirements, fulfill the requirements of the contracts with the applicants, and satisfy the applicable codes, standards, and regulatory requirements. This program satisfies the NRC Quality Assurance Criteria, 10CFR50 Appendix B, to the extent that these criteria apply to safety related NSSS equipment. Also, it follows the regulatory position provided in NRC regulatory guides and the requirements of ANSI Standard N45.2.12 as identified in this Topical Report

  9. 75 FR 61143 - Meeting of the Advisory Committee on Blood Safety and Availability

    Science.gov (United States)

    2010-10-04

    ... and availability of the blood supply and blood products, (2) broad public health, ethical and legal... availability of various economic factors affecting product cost and supply. In keeping with its established...

  10. Continuous Postoperative Pericardial Flushing: A Pilot Study on Safety, Feasibility, and Effect on Blood Loss

    NARCIS (Netherlands)

    Manshanden, Johan S. J.; Gielen, Chantal L. I.; de Borgie, Corianne A. J. M.; Klautz, Robert J. M.; de Mol, Bas A. J. M.; Koolbergen, David R.

    2015-01-01

    Background: Prolonged or excessive blood loss is a common complication after cardiac surgery. Blood remnants and clots, remaining in the pericardial space in spite of chest tube drainage, induce high fibrinolytic activity that may contribute to bleeding complications. Continuous postoperative

  11. 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.

  12. Quality assurance in the project of RECH-2 research reactor

    International Nuclear Information System (INIS)

    Goycolea Donoso, C.; Nino de Zepeda Schele, A.

    1989-01-01

    The implantation of a Quality Assurance Program for the design, supply, construction, installation, and testing of the RECH-2 research reactor, is described in this paper. The obtained results, demonstrate that a Quality Assurance Program constitutes a suitable mean to assure that the installation complies with the safety and reliability requirements. (author)

  13. Safety profile and long-term engraftment of human CD31+ blood progenitors in bone tissue engineering.

    Science.gov (United States)

    Zigdon-Giladi, Hadar; Elimelech, Rina; Michaeli-Geller, Gal; Rudich, Utai; Machtei, Eli E

    2017-07-01

    Endothelial progenitor cells (EPCs) participate in angiogenesis and induce favorable micro-environments for tissue regeneration. The efficacy of EPCs in regenerative medicine is extensively studied; however, their safety profile remains unknown. Therefore, our aims were to evaluate the safety profile of human peripheral blood-derived EPCs (hEPCs) and to assess the long-term efficacy of hEPCs in bone tissue engineering. hEPCs were isolated from peripheral blood, cultured and characterized. β tricalcium phosphate scaffold (βTCP, control) or 10 6 hEPCs loaded onto βTCP were transplanted in a nude rat calvaria model. New bone formation and blood vessel density were analyzed using histomorphometry and micro-computed tomography (CT). Safety of hEPCs using karyotype analysis, tumorigenecity and biodistribution to target organs was evaluated. On the cellular level, hEPCs retained their karyotype during cell expansion (seven passages). Five months following local hEPC transplantation, on the tissue and organ level, no inflammatory reaction or dysplastic change was evident at the transplanted site or in distant organs. Direct engraftment was evident as CD31 human antigens were detected lining vessel walls in the transplanted site. In distant organs human antigens were absent, negating biodistribution. Bone area fraction and bone height were doubled by hEPC transplantation without affecting mineral density and bone architecture. Additionally, local transplantation of hEPCs increased blood vessel density by nine-fold. Local transplantation of hEPCs showed a positive safety profile. Furthermore, enhanced angiogenesis and osteogenesis without mineral density change was found. These results bring us one step closer to first-in-human trials using hEPCs for bone regeneration. Copyright © 2017 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  14. Safety

    International Nuclear Information System (INIS)

    1998-01-01

    A brief account of activities carried out by the Nuclear power plants Jaslovske Bohunice in 1997 is presented. These activities are reported under the headings: (1) Nuclear safety; (2) Industrial and health safety; (3) Radiation safety; and Fire protection

  15. Screening for transfusion transmissible infections using rapid diagnostic tests in Africa: a potential hazard to blood safety?

    Science.gov (United States)

    Prugger, C.; Laperche, S.; Murphy, E. L.; Bloch, E. M.; Kaidarova, Z.; Tafflet, M.; Lefrère, J.-J.; Jouven, X.

    2016-01-01

    Rapid diagnostic tests (RDTs) are routinely used in African blood centres. We analysed data from two cross-sectional studies representing 95 blood centres in 29 African countries. Standardized panels of sera containing varying concentrations of anti-human immunodeficiency virus (HIV) antibodies (Ab), hepatitis B virus antigen (HBsAg) and antihepatitis C virus (HCV) Ab were screened using routine operational testing procedures at the centres. Sensitivity of detection using RDTs was high for HIV Ab-positive samples, but low for intermediately HBsAg (51·5%) and HCV Ab (40·6%)-positive samples. These findings suggest that current RDT use in Africa could pose a hazard to blood safety. PMID:26646317

  16. Quality Assurance - Construction

    DEFF Research Database (Denmark)

    Gaarslev, Axel

    1996-01-01

    Gives contains three main chapters:1. Quality Assurance initiated by external demands2. Quality Assurance initiated by internal company goals3. Innovation strategies......Gives contains three main chapters:1. Quality Assurance initiated by external demands2. Quality Assurance initiated by internal company goals3. Innovation strategies...

  17. 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)

  18. Blood

    Science.gov (United States)

    ... a reduced production of red blood cells, including: Iron deficiency anemia. Iron deficiency anemia is the most common type of anemia and ... inflammatory bowel disease are especially likely to have iron deficiency anemia. Anemia due to chronic disease. People with chronic ...

  19. Introduction to quality assurance

    International Nuclear Information System (INIS)

    Kaden, W.

    1980-01-01

    In today's interpretation 'quality assurance' means 'good management'. Quality assurance has to cover all phases of a work, but all quality assurance measures must be adapted to the relevance and complexity of the actual task. Examples are given for the preparation of quality classes, the organization of quality assurance during design and manufacturing and for auditing. Finally, efficiency and limits of quality assurance systems are described. (orig.)

  20. 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.

  1. 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.

  2. Quality management and quality assurance

    International Nuclear Information System (INIS)

    Pieroni, N.

    1991-01-01

    The main common difficulties are presented found in the implementation of effective Quality Management and Quality Assurance Programmes, based on the recommendations of the IAEA International Nuclear Safety Advisory Group, the information collected by the IAEA experts participating in its meetings, and the results of the IAEA Operational Safety Review Team missions. The difficulties were identified in several areas. The most relevant root causes can be characterized as lack of understanding of quality principles and difficulty in implementation by the responsible management. The IAEA programme is described attempting to provide advice and support in the implementation of an effective quality programme through a number of activities including: preparation of practical guidelines, training programmes for management personnel, assistance in building up qualified manpower, and promoting the quest for excellence through the exchange of experience in the implementation of effective Quality Management and Quality Assurance Programmes in nuclear power plants with good performance records. (Z.S.)

  3. Catheter-Based Measurements of Absolute Coronary Blood Flow and Microvascular Resistance: Feasibility, Safety, and Reproducibility in Humans.

    Science.gov (United States)

    Xaplanteris, Panagiotis; Fournier, Stephane; Keulards, Daniëlle C J; Adjedj, Julien; Ciccarelli, Giovanni; Milkas, Anastasios; Pellicano, Mariano; Van't Veer, Marcel; Barbato, Emanuele; Pijls, Nico H J; De Bruyne, Bernard

    2018-03-01

    The principle of continuous thermodilution can be used to calculate absolute coronary blood flow and microvascular resistance (R). The aim of the study is to explore the safety, feasibility, and reproducibility of coronary blood flow and R measurements as measured by continuous thermodilution in humans. Absolute coronary flow and R can be calculated by thermodilution by infusing saline at room temperature through a dedicated monorail catheter. The temperature of saline as it enters the vessel, the temperature of blood and saline mixed in the distal part of the vessel, and the distal coronary pressure were measured by a pressure/temperature sensor-tipped guidewire. The feasibility and safety of the method were tested in 135 patients who were referred for coronary angiography. No significant adverse events were observed; in 11 (8.1%) patients, bradycardia and concomitant atrioventricular block appeared transiently and were reversed immediately on interruption of the infusion. The reproducibility of measurements was tested in a subgroup of 80 patients (129 arteries). Duplicate measurements had a strong correlation both for coronary blood flow (ρ=0.841, P <0.001; intraclass correlation coefficient=0.89, P <0.001) and R (ρ=0.780, P <0.001; intraclass correlation coefficient=0.89, P <0.001). In Bland-Altman plots, there was no significant bias or asymmetry. Absolute coronary blood flow (in L/min) and R (in mm Hg/L/min or Wood units) can be safely and reproducibly measured with continuous thermodilution. This approach constitutes a new opportunity for the study of the coronary microcirculation. © 2018 American Heart Association, Inc.

  4. Human immunodeficiency virus prevalence, incidence, and residual transmission risk in first-time and repeat blood donations in Zimbabwe: implications on blood safety.

    Science.gov (United States)

    Mapako, Tonderai; Mvere, David A; Chitiyo, McLeod E; Rusakaniko, Simbarashe; Postma, Maarten J; van Hulst, Marinus

    2013-10-01

    National Blood Service Zimbabwe human immunodeficiency virus (HIV) risk management strategy includes screening and discarding of first-time donations, which are collected in blood packs without an anticoagulant (dry pack). To evaluate the impact of discarding first-time donations on blood safety the HIV prevalence, incidence, and residual risk in first-time and repeat donations (wet packs) were compared. Donor data from 2002 to 2010 were retrieved from a centralized national electronic donor database and retrospectively analyzed. Chi-square test was used to compare HIV prevalence with relative risk (RR), and the RR point estimates and 95% confidence interval (CI) are reported. Trend analysis was done using Cochran-Armitage trend test. HIV residual risk estimates were determined using published residual risk estimation models. Over the 9 years the overall HIV prevalence estimates are 1.29% (n = 116,058) and 0.42% (n = 434,695) for first-time and repeat donations, respectively. The overall RR was 3.1 (95% CI, 2.9-3.3; p donations in first-time was 1:7384 (range, 1:11,308-1:5356) and in repeat donors it was 1:5496 (range, 1:9943-1:3347). The significantly high HIV prevalence estimates recorded in first-time over repeat donations is indicative of the effectiveness of the HIV risk management strategy. However, comparable residual transmission risk estimates in first-time and repeat donors point to the need to further review the risk management strategies. Given the potential wastage of valuable resources, future studies should focus on the cost-effectiveness and utility of screening and discarding first-time donations. © 2013 American Association of Blood Banks.

  5. Regulatory viewpoint on nuclear fuel quality assurance

    International Nuclear Information System (INIS)

    Tripp, L.E.

    1976-01-01

    Considerations of the importance of fuel quality and performance to nuclear safety, ''as low reasonably achievable'' release of radioactive materials in reactor effluents, and past fuel performance problems demonstrate the need for strong regulatory input, review and inspection of nuclear fuel quality assurance programs at all levels. Such a regulatory program is being applied in the United States of America by the US Nuclear Regulatory Commission. Quality assurance requirements are contained within government regulations. Guidance on acceptable methods of implementing portions of the quality assurance program is contained within Regulatory Guides and other NRC documents. Fuel supplier quality assurance program descriptions are reviewed as a part of the reactor licensing process. Inspections of reactor licensee control of their fuel vendors as well as direct inspections of fuel vendor quality assurance programs are conducted on a regularly scheduled basis. (author)

  6. Patient safety with blood products administration using wireless and bar-code technology.

    Science.gov (United States)

    Porcella, Aleta; Walker, Kristy

    2005-01-01

    Supported by a grant from the Agency for Healthcare Research and Quality, a University of Iowa Hospitals and Clinics interdisciplinary research team created an online data-capture-response tool utilizing wireless mobile devices and bar code technology to track and improve blood products administration process. The tool captures 1) sample collection, 2) sample arrival in the blood bank, 3) blood product dispense from blood bank, and 4) administration. At each step, the scanned patient wristband ID bar code is automatically compared to scanned identification barcode on requisition, sample, and/or product, and the system presents either a confirmation or an error message to the user. Following an eight-month, 5 unit, staged pilot, a 'big bang,' hospital-wide implementation occurred on February 7, 2005. Preliminary results from pilot data indicate that the new barcode process captures errors 3 to 10 times better than the old manual process.

  7. Continuous Postoperative Pericardial Flushing: A Pilot Study on Safety, Feasibility, and Effect on Blood Loss

    Directory of Open Access Journals (Sweden)

    Johan S.J. Manshanden

    2015-09-01

    Conclusions: CPPF after cardiac surgery was found to be safe and feasible in this experimental setting. The clinically relevant effect on blood loss needs to be confirmed in a randomized clinical trial.

  8. Manpower requirements for quality assurance during operation

    International Nuclear Information System (INIS)

    Pratt, J.M.; Sollenberger, L.G.

    1982-01-01

    As a result of the Three Mile Island accident and the findings presented in various investigatory reports, some fundamental changes are taking place in the role and scope of quality assurance. Recent changes to United States national codes, guides and standards are analysed in order to identify the principles involved. This analysis shows that the scope of the programme is being extended beyond the equipment designated 'nuclear safety related' and greater emphasis is being placed upon the independent verification of the satisfactory performance of activities affecting safety. Such fundamental changes could lead to a significant increase in the number of quality assurance personnel required to support an operating nuclear power plant. The evolving quality assurance organization at Three Mile Island is used to illustrate how these fundamental changes could affect the quality assurance organization and manpower requirements. (author)

  9. 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

  10. Determination of safety margins for whole blood concentrations of alcohol and nineteen drugs in driving under the influence cases.

    Science.gov (United States)

    Kristoffersen, Lena; Strand, Dag Helge; Liane, Veronica Horpestad; Vindenes, Vigdis; Tvete, Ingunn Fride; Aldrin, Magne

    2016-02-01

    Legislative limits for driving under the influence of 20 non-alcohol drugs were introduced in Norway in February 2012. Per se limits corresponding to blood alcohol concentrations (BAC) of 0.2g/kg were established for 20 psychoactive drugs, and limits for graded sanctions corresponding to BACs of 0.5 and 1.2g/kg were determined for 13 of these drugs. This new legislation made it possible for the courts to make sentences based on the analytical results, similar to the situation for alcohol. To ensure that the reported concentration is as least as high as the true concentration, with a 99% safety level, safety margins had to be calculated for each of the substances. Diazepam, tetrahydrocannabinol (THC) and alcohol were used as model substances to establish a new model for estimating the safety margins. The model was compared with a previous used model established several years ago, by a similar yet much simpler model, and they were found to be in agreement. The measurement uncertainties depend on the standard batch used, the work list and the measurements' replicate. A Bayesian modelling approach was used to determine the parameters in the model, using a dataset of 4700 diazepam positive specimens and 5400 THC positive specimens. Different safety margins were considered for low and high concentration levels of diazepam (≤2μM (0.6mg/L) and >2μM) and THC (≤0.01μM (0.003mg/L) and >0.01μM). The safety margins were for diazepam 19.5% (≤2μM) and 34% (>2μM), for THC 19.5% (≤0.01μM) and 24.9% (>0.01μM). Concentration dependent safety margins for BAC were based on a dataset of 29500 alcohol positive specimens, and were in the range 10.4% (0.1g/kg) to 4.0% (4.0g/kg) at a 99% safety level. A simplified approach was used to establish safety margins for the compounds amphetamine, MDMA, methamphetamine, alprazolam, phenazepam, flunitrazepam, clonazepam, nitrazepam, oxazepam, buprenorphine, GHB, methadone, ketamine, cocaine, morphine, zolpidem and zopiclone. The

  11. Commissioning quality assurance for nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1986-09-01

    This standard contains the requirements for the quality assurance program applicable to the commissioning phase of a nuclear power plant. This standard embodies the relevant quality assurance requirements of CSA Standard CAN3-N286.0, and is the governing Standard for commissioning quality assurance activities in the event of any conflicting requirements. This Standard applies to the commissioning of safety-related equipment, systems, and structures as identified by the owner. It may be applied to other equipment, systems, and structures at the discretion of the owner. 1 fig.

  12. A Quality Assurance Program for decommissioning

    International Nuclear Information System (INIS)

    Briggs, P.M.

    1986-01-01

    Defining the Quality Assurance Program for the US Department of Energy Shippingport Station Decommissioning Project (SSDP) was a unique opportunity because this is the first full-sized commercial nuclear power plant to be decommissioned. General Electric Company defined a Quality Assurance Program that provided adequate control, yet was stripped down to the essentials. The Program is designed to provide a flexible degree of monitoring of subcontractor work, built around a core of radiation safety monitoring, detailed planning, inspection and auditing, and operated with a minimum of dedicated personnel. This paper will concentrate on the traditional quality assurance activities, leaving radiation and environmental monitoring for other presentations

  13. Quality assurance organization of the plant owner

    International Nuclear Information System (INIS)

    Staebler, K.

    1980-01-01

    It is not the primary task of the plant owner to assure the quality during erection. It is, however, his responsibility to check the quality assurance system established by the plant, the supplier and the subcontractor. In the lecture, it is shown that the plant owners do this control in the best efficient way. The special consideration of the plant owner in deciding questions of quality assurance is demonstrated by special examples. The meaning of basic safety for the plant owner is presented. (orig./RW)

  14. Commissioning quality assurance for nuclear power plants

    International Nuclear Information System (INIS)

    1986-09-01

    This standard contains the requirements for the quality assurance program applicable to the commissioning phase of a nuclear power plant. This standard embodies the relevant quality assurance requirements of CSA Standard CAN3-N286.0, and is the governing Standard for commissioning quality assurance activities in the event of any conflicting requirements. This Standard applies to the commissioning of safety-related equipment, systems, and structures as identified by the owner. It may be applied to other equipment, systems, and structures at the discretion of the owner. 1 fig

  15. The new Scandinavian Donations and Transfusions database (SCANDAT2): a blood safety resource with added versatility.

    Science.gov (United States)

    Edgren, Gustaf; Rostgaard, Klaus; Vasan, Senthil K; Wikman, Agneta; Norda, Rut; Pedersen, Ole Birger; Erikstrup, Christian; Nielsen, Kaspar René; Titlestad, Kjell; Ullum, Henrik; Melbye, Mads; Nyrén, Olof; Hjalgrim, Henrik

    2015-07-01

    Risks of transfusion-transmitted disease are currently at a record low in the developed world. Still, available methods for blood surveillance might not be sufficient to detect transmission of diseases with unknown etiologies or with very long incubation periods. We have previously created the anonymized Scandinavian Donations and Transfusions (SCANDAT) database, containing data on blood donors, blood transfusions, and transfused patients, with complete follow-up of donors and patients for a range of health outcomes. Here we describe the re-creation of SCANDAT with updated, identifiable data. We collected computerized data on blood donations and transfusions from blood banks covering all of Sweden and Denmark. After data cleaning, two structurally identical databases were created and the entire database was linked with nationwide health outcomes registers to attain complete follow-up for up to 47 years regarding hospital care, cancer, and death. After removal of erroneous records, the database contained 25,523,334 donation records, 21,318,794 transfusion records, and 3,692,653 unique persons with valid identification, presently followed over 40 million person-years, with possibility for future extension. Data quality is generally high with 96% of all transfusions being traceable to their respective donation(s) and a very high (>97%) concordance with official statistics on annual number of blood donations and transfusions. It is possible to create a binational, nationwide database with almost 50 years of follow-up of blood donors and transfused patients for a range of health outcomes. We aim to use this database for further studies of donor health, transfusion-associated risks, and transfusion-transmitted disease. © 2015 AABB.

  16. Computer software quality assurance

    International Nuclear Information System (INIS)

    Ives, K.A.

    1986-06-01

    The author defines some criteria for the evaluation of software quality assurance elements for applicability to the regulation of the nuclear industry. The author then analyses a number of software quality assurance (SQA) standards. The major extracted SQA elements are then discussed, and finally specific software quality assurance recommendations are made for the nuclear industry

  17. Data Quality Assurance Governance

    OpenAIRE

    Montserrat Gonzalez; Stephanie Suhr

    2016-01-01

    This deliverable describes the ELIXIR-EXCELERATE Quality Management Strategy, addressing EXCELERATE Ethics requirement no. 5 on Data Quality Assurance Governance. The strategy describes the essential procedures and practices within ELIXIR-EXCELERATE concerning planning of quality management, performing quality assurance and controlling quality. It also depicts the overall organisation of ELIXIR with emphasis on authority and specific responsibilities related to quality assurance.

  18. Multinational Quality Assurance

    Science.gov (United States)

    Kinser, Kevin

    2011-01-01

    Multinational colleges and universities pose numerous challenges to the traditional models of quality assurance that are designed to validate domestic higher education. When institutions cross international borders, at least two quality assurance protocols are involved. To guard against fraud and abuse, quality assurance in the host country is…

  19. 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...

  20. [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.

  1. 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.

  2. Renal denervation beyond the bifurcation: The effect of distal ablation placement on safety and blood pressure.

    Science.gov (United States)

    Beeftink, Martine M A; Spiering, Wilko; De Jong, Mark R; Doevendans, Pieter A; Blankestijn, Peter J; Elvan, Arif; Heeg, Jan-Evert; Bots, Michiel L; Voskuil, Michiel

    2017-04-01

    Renal denervation may be more effective if performed distal in the renal artery because of smaller distances between the lumen and perivascular nerves. The authors reviewed the angiographic results of 97 patients and compared blood pressure reduction in relation to the location of the denervation. No significant differences in blood pressure reduction or complications were found between patient groups divided according to their spatial distribution of the ablations (proximal to the bifurcation in both arteries, distal to the bifurcation in one artery and distal in the other artery, or distal to the bifurcation in both arteries), but systolic ambulatory blood pressure reduction was significantly related to the number of distal ablations. No differences in adverse events were observed. In conclusion, we found no reason to believe that renal denervation distal to the bifurcation poses additional risks over the currently advised approach of proximal denervation, but improved efficacy remains to be conclusively established. ©2017 Wiley Periodicals, Inc.

  3. Analysis of compatibility of current Czech initial documentation in the area of technical assurance of nuclear safety with the requirements of the EUR document

    International Nuclear Information System (INIS)

    Zdebor, J.; Zdebor, R.; Kratochvil, L.

    2001-11-01

    The publication is structured as follows: Description of existing documentation. General requirements, goals, principles and design principles: Documents being compared; Method of comparison; Results and partial evaluation of comparison of requirements between EUR and Czech regulations (basic goals and safety philosophy; quantitative safety objectives; basic design requirements; extended design requirements; external and internal threats; technical requirements; site conditions); Summary of the comparison of safety requirements. Comparison of requirements for the systems: Requirements for the nuclear reactor unit systems; Barrier systems (fuel system; reactor cooling system; containment system); Remaining systems (control systems; protection systems; coolant makeup and purification system; residual heat removal system; emergency cooling system; power systems); Common technical requirements for systems (technical requirements for systems; internal and external events). (P.A.)

  4. Management of national nuclear power programs for assured safety. Report of visit by international participants to INEL on August 24, 1985

    International Nuclear Information System (INIS)

    Rouhani, S.Z.

    1985-10-01

    Through a special arrangement with the US State Department and support from the Department of Energy a group of high ranking officials from six different countries visited the Idaho National Engineering Laboratory on August 24, 1985. They were briefed on the highlights of the US-NRC's nuclear safety research programs at the INEL. The purpose of this project was to broadcast the advancements of the US nuclear safety technology to other nations that are at the start of major programs for peaceful use of nuclear energy in their countries

  5. Reliability assurance for regulation of advanced reactors

    International Nuclear Information System (INIS)

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

    1991-01-01

    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

  6. Reliability assurance for regulation of advanced reactors

    International Nuclear Information System (INIS)

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

    1992-01-01

    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

  7. 75 FR 71444 - Renewal of Charter for the Advisory Committee on Blood Safety and Availability

    Science.gov (United States)

    2010-11-23

    ... FURTHER INFORMATION CONTACT: Jerry Holmberg, PhD; Senior Advisor for Blood Policy and Executive Secretary... provides advice and guidance to the Secretary, through the Assistant Secretary for Health, on a range of... advice and guidance includes, but is not limited to: (1) Definition of public health parameters around...

  8. Renal denervation beyond the bifurcation : The effect of distal ablation placement on safety and blood pressure

    NARCIS (Netherlands)

    Beeftink, Martine M A; Spiering, Wilko; De Jong, Mark R.; Doevendans, Pieter A.; Blankestijn, Peter J.; Elvan, Arif; Heeg, Jan Evert; Bots, Michiel L.; Voskuil, Michiel

    2017-01-01

    Renal denervation may be more effective if performed distal in the renal artery because of smaller distances between the lumen and perivascular nerves. The authors reviewed the angiographic results of 97 patients and compared blood pressure reduction in relation to the location of the denervation.

  9. 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

  10. A systematic assessment of quality assurance-based food safety management system of Chinese edible oil manufacturer in view of context characteristics

    NARCIS (Netherlands)

    Ren, Yingxue; He, Zhen; Luning, Pieternel A.

    2016-01-01

    This study uses a framework of a food safety management system-diagnostic instrument (FSMS-DI), for the assessment of the context of a Chinese edible oil manufacture through the view of a case study, and an evaluation of the performance of the FSMS of a Chinese edible oil company. The study

  11. Safety

    International Nuclear Information System (INIS)

    2001-01-01

    This annual report of the Senior Inspector for the Nuclear Safety, analyses the nuclear safety at EDF for the year 1999 and proposes twelve subjects of consideration to progress. Five technical documents are also provided and discussed concerning the nuclear power plants maintenance and safety (thermal fatigue, vibration fatigue, assisted control and instrumentation of the N4 bearing, 1300 MW reactors containment and time of life of power plants). (A.L.B.)

  12. The application of quality assurance

    International Nuclear Information System (INIS)

    Lovatt, G.B.

    1988-01-01

    The paper concerns the application of quality assurance to structures, systems and components for the design, construction and operation of nuclear power plant and fuel reprocessing plant. A description is given of:- the requirements for quality assurance, the establishment of quality assurance arrangements, quality assurance documents structure, and quality assurance manuals and programmes. Quality assurance procedures and auditing are also discussed. (U.K.)

  13. Quality assurance of nuclear energy

    International Nuclear Information System (INIS)

    1994-12-01

    It consists of 14 chapters, which are outline of quality assurance of nuclear energy, standard of quality assurance, business quality assurance, design quality assurance, purchase quality assurance, production quality assurance, a test warranty operation warranty, maintenance warranty, manufacture of nuclear power fuel warranty, computer software warranty, research and development warranty and quality audit.

  14. New techniques in quality assurance

    International Nuclear Information System (INIS)

    Fornicola, J.C.

    1987-01-01

    GPU Nuclear Corp. has a multifaceted quality assurance (QA) program. This program includes a comprehensive QA organization to help ensure its implementation. The QA organization employs various techniques in assuring quality at GPU Nuclear. These techniques not only include the typical QA/quality-control verification activities, i.e., QA engineering, quality control, and audits, but also include some new innovative techniques. Several new techniques have been developed for verifying activities. These techniques include monitoring and functional audits of safety systems. Several new techniques for assessing performance and adequacy and effectiveness of plant and QA programs, such as plant assessments and QA systems engineering evaluations, have also been developed. This paper provides an overview of these and other new techniques being employed by GPU Nuclear's QA organization

  15. Climate change projections of West Nile virus infections in Europe: implications for blood safety practices.

    Science.gov (United States)

    Semenza, Jan C; Tran, Annelise; Espinosa, Laura; Sudre, Bertrand; Domanovic, Dragoslav; Paz, Shlomit

    2016-03-08

    West Nile virus (WNV) is transmitted by mosquitoes in both urban as well as in rural environments and can be pathogenic in birds, horses and humans. Extrinsic factors such as temperature and land use are determinants of WNV outbreaks in Europe, along with intrinsic factors of the vector and virus. With a multivariate model for WNV transmission we computed the probability of WNV infection in 2014, with July 2014 temperature anomalies. We applied the July temperature anomalies under the balanced A1B climate change scenario (mix of all energy sources, fossil and non-fossil) for 2025 and 2050 to model and project the risk of WNV infection in the future. Since asymptomatic infections are common in humans (which can result in the contamination of the donated blood) we estimated the predictive prevalence of WNV infections in the blood donor population. External validation of the probability model with 2014 cases indicated good prediction, based on an Area Under Curve (AUC) of 0.871 (SD = 0.032), on the Receiver Operating Characteristic Curve (ROC). The climate change projections for 2025 reveal a higher probability of WNV infection particularly at the edges of the current transmission areas (for example in Eastern Croatia, Northeastern and Northwestern Turkey) and an even further expansion in 2050. The prevalence of infection in (blood donor) populations in the outbreak-affected districts is expected to expand in the future. Predictive modelling of environmental and climatic drivers of WNV can be a valuable tool for public health practice. It can help delineate districts at risk for future transmission. These areas can be subjected to integrated disease and vector surveillance, outreach to the public and health care providers, implementation of personal protective measures, screening of blood donors, and vector abatement activities.

  16. Experiment Safety Assurance Package for the 40- to 50-GWd/MT Burnup Phase of Mixed Oxide Fuel Irradiation in Small I-Hole Positions in the Advanced Test Reactor

    Energy Technology Data Exchange (ETDEWEB)

    Khericha, S.T.

    2002-06-30

    This experiment safety assurance package (ESAP) is a revision of the last MOX ESAP issued in February 2001(Khericha 2001). The purpose of this revision is to identify the changes in the loading pattern and to provide a basis to continue irradiation up to {approx}42 GWd/MT burnup (+ 2.5%) as predicted by MCNP (Monte Carlo N-Particle) transport code before the preliminary postirradiation examination (PIE) results for 40 GWd/MT burnup are available. Note that the safety analysis performed for the last ESAP is still applicable and no additional analysis is required (Khericha 2001). In July 2001, it was decided to reconfigure the test assembly using the loading pattern for Phase IV, Part 3, at the end of Phase IV, Part 1, as the loading pattern for Phase IV, Parts 2 and 3. Three capsule assemblies will be irradiated until the highest burnup capsule assembly accumulates: {approx}50 GWd/MT burnup, based on the MCNP code predictions. The last ESAP suggests that at the end of Phase IV, Part 1, we remove the two highest burnup capsule assemblies ({at} {approx}40 GWd/MT burnup) and send them to ORNL for PIE. Then, irradiate the test assembly using the loading pattern for Phase IV, Part 2, until the highest burnup capsule reaches {approx}40 GWd/MT burnup per MCNP-predicted values.

  17. High assurance SPIRAL

    Science.gov (United States)

    Franchetti, Franz; Sandryhaila, Aliaksei; Johnson, Jeremy R.

    2014-06-01

    In this paper we introduce High Assurance SPIRAL to solve the last mile problem for the synthesis of high assurance implementations of controllers for vehicular systems that are executed in today's and future embedded and high performance embedded system processors. High Assurance SPIRAL is a scalable methodology to translate a high level specification of a high assurance controller into a highly resource-efficient, platform-adapted, verified control software implementation for a given platform in a language like C or C++. High Assurance SPIRAL proves that the implementation is equivalent to the specification written in the control engineer's domain language. Our approach scales to problems involving floating-point calculations and provides highly optimized synthesized code. It is possible to estimate the available headroom to enable assurance/performance trade-offs under real-time constraints, and enables the synthesis of multiple implementation variants to make attacks harder. At the core of High Assurance SPIRAL is the Hybrid Control Operator Language (HCOL) that leverages advanced mathematical constructs expressing the controller specification to provide high quality translation capabilities. Combined with a verified/certified compiler, High Assurance SPIRAL provides a comprehensive complete solution to the efficient synthesis of verifiable high assurance controllers. We demonstrate High Assurance SPIRALs capability by co-synthesizing proofs and implementations for attack detection and sensor spoofing algorithms and deploy the code as ROS nodes on the Landshark unmanned ground vehicle and on a Synthetic Car in a real-time simulator.

  18. General safety aspects

    International Nuclear Information System (INIS)

    1998-01-01

    In this part next aspects are described: (1) Priority to safety; (2) Financial and human resources;; (3) Human factor; (4) Operator's quality assurance system; (5) Safety assessment and Verification; (6) Radiation protection and (7) Emergency preparedness

  19. Quality assurance for fittings considering nuclear technology

    International Nuclear Information System (INIS)

    Kilian, H.J.

    1987-01-01

    Negative experience made during World War II led to the idea of quality assurance being born in the United States. Thoroughly misunderstood, it came to be incorporated in European mechanical engineering. Quality assurance there was initially considered to be a new term for the oganizational combination of all parts of an enterprise dealing with testing. German manufacturers of heavy-duty and safety fittings represented in the international market were compelled at a relatively early date to properly understand and realize a quality assurance programme. But the multi-fariousness of specifications to be applied and great number of the most different parts made eminent demands on the suitability and variability of the products developed. On the basis of 18 quality criteria the article describes the structure of 'quality' and what its consequences are for an effective quality assurance system - suited for all kinds of specifications. (orig.) [de

  20. The NHLBI Retrovirus Epidemiology Donor Studies (REDS and REDS-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.

    2012-01-01

    The Retrovirus Epidemiology Donor Study (REDS), conducted from 1989–2001, and the Retrovirus Epidemiology Donor Study-II (REDS-II), conducted from 2004–2012, were National Heart Lung and Blood Institute (NHLBI) funded multicenter programs focused on improving blood safety and availability in the United States. REDS-II also included international study sites in Brazil and China. The three 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 XMRV. Blood safety studies have included protocols evaluating epidemiologic and/or laboratory aspects of HIV, HTLV I/II, HCV, HBV, WNV, CMV, HHV-8, B19V, malaria, CJD, influenza, and T. 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, two 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 two REDS programs. In 2011, a new seven year program, the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III), was launched. REDS-III expands beyond donor-based research to include studies of blood transfusion recipients in the hospital setting, and adds a third country, South Africa, to the international program. PMID:22633182

  1. Focused ultrasound-mediated noninvasive blood-brain barrier modulation: preclinical examination of efficacy and safety in various sonication parameters.

    Science.gov (United States)

    Shin, Jaewoo; Kong, Chanho; Cho, Jae Sung; Lee, Jihyeon; Koh, Chin Su; Yoon, Min-Sik; Na, Young Cheol; Chang, Won Seok; Chang, Jin Woo

    2018-02-01

    OBJECTIVE The application of pharmacological therapeutics in neurological disorders is limited by the ability of these agents to penetrate the blood-brain barrier (BBB). Focused ultrasound (FUS) has recently gained attention for its potential application as a method for locally opening the BBB and thereby facilitating drug delivery into the brain parenchyma. However, this method still requires optimization to maximize its safety and efficacy for clinical use. In the present study, the authors examined several sonication parameters of FUS influencing BBB opening in small animals. METHODS Changes in BBB permeability were observed during transcranial sonication using low-intensity FUS in 20 adult male Sprague-Dawley rats. The authors examined the effects of FUS sonication with different sonication parameters, varying acoustic pressure, center frequency, burst duration, microbubble (MB) type, MB dose, pulse repetition frequency (PRF), and total exposure time. The focal region of BBB opening was identified by Evans blue dye. Additionally, H & E staining was used to identify blood vessel damage. RESULTS Acoustic pressure amplitude and burst duration were closely associated with enhancement of BBB opening efficiency, but these parameters were also highly correlated with tissue damage in the sonicated region. In contrast, MB types, MB dose, total exposure time, and PRF had an influence on BBB opening without conspicuous tissue damage after FUS sonication. CONCLUSIONS The study aimed to identify these influential conditions and provide safety and efficacy values for further studies. Future work based on the current results is anticipated to facilitate the implementation of FUS sonication for drug delivery in various CNS disease states in the near future.

  2. Quality assurance of nuclear fuel

    International Nuclear Information System (INIS)

    1994-01-01

    The guide presents the quality assurance requirements to be completed with in the procurement, design, manufacture, transport, handling and operation of the nuclear fuel. The guide also applies to the procurement of the control rods and the shield elements to be placed in the reactor. The guide is mainly aimed for the licensee responsible for the procurement and operation of fuel, for the fuel designer and manufacturer and for other organizations whose activities affect fuel quality, the safety of fuel transport, storage and operation. (2 refs.)

  3. Identification errors in the blood transfusion laboratory: a still relevant issue for patient safety.

    Science.gov (United States)

    Lippi, Giuseppe; Plebani, Mario

    2011-04-01

    Remarkable technological advances and increased awareness have both contributed to decrease substantially the uncertainty of the analytical phase, so that the manually intensive preanalytical activities currently represent the leading sources of errors in laboratory and transfusion medicine. Among preanalytical errors, misidentification and mistransfusion are still regarded as a considerable problem, posing serious risks for patient health and carrying huge expenses for the healthcare system. As such, a reliable policy of risk management should be readily implemented, developing through a multifaceted approach to prevent or limit the adverse outcomes related to transfusion reactions from blood incompatibility. This strategy encompasses root cause analysis, compliance with accreditation requirements, strict adherence to standard operating procedures, guidelines and recommendations for specimen collection, use of positive identification devices, rejection of potentially misidentified specimens, informatics data entry, query host communication, automated systems for patient identification and sample labeling and an adequate and safe environment. Copyright © 2011 Elsevier Ltd. All rights reserved.

  4. Hanford Tanks Initiative quality assurance implementation plan

    International Nuclear Information System (INIS)

    Huston, J.J.

    1998-01-01

    Hanford Tanks Initiative (HTI) Quality Assurance Implementation Plan for Nuclear Facilities defines the controls for the products and activities developed by HTI. Project Hanford Management Contract (PHMC) Quality Assurance Program Description (QAPD)(HNF-PRO599) is the document that defines the quality requirements for Nuclear Facilities. The QAPD provides direction for compliance to 10 CFR 830.120 Nuclear Safety Management, Quality Assurance Requirements. Hanford Tanks Initiative (HTI) is a five-year activity resulting from the technical and financial partnership of the US Department of Energy's Office of Waste Management (EM-30), and Office of Science and Technology Development (EM-50). HTI will develop and demonstrate technologies and processes for characterization and retrieval of single shell tank waste. Activities and products associated with HTI consist of engineering, construction, procurement, closure, retrieval, characterization, and safety and licensing

  5. Safety evaluation of phytosterols in laying hens: effects on laying performance, clinical blood parameters, and organ development.

    Science.gov (United States)

    Shi, S R; Shen, Y R; Chang, L L; Zhou, C J; Bo, Z; Wang, Z Y; Tong, H B; Zou, J M

    2014-03-01

    Phytosterols are intended for use as a novel food ingredient with plasma cholesterol-lowering activity. Although phytosterols are naturally present in the normal diet, daily consumption is insufficient to ensure plasma cholesterol-lowering levels. Therefore, phytosterols may be added to the diets to achieve the desired cholesterol-lowering activity. A subchronic laying hen safety study was conducted to examine if high-dose phytosterols could affect the safety of hens. Three hundred sixty 21-wk-old Hy-Line Brown laying hens were randomly assigned to 5 groups with 6 replicates of 12 birds each; after 3 wk, birds were fed diets supplemented with 0, 20, 80, 400, and 800 mg/kg of phytosterols for 12 wk. Throughout the study, clinical observations and laying performance were measured. At the end of the study, birds were subjected to a full postmortem examination: blood samples were taken for clinical pathology, selected organs were weighed, and specified tissues were taken for subsequent histological examination. No treatment-related changes that were considered to be of toxicological significance were observed. Therefore, a nominal phytosterol concentration of 800 mg/kg was considered to be the no-observed-adverse-effect level.

  6. 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.

  7. Quality assurance in tube manufacture

    International Nuclear Information System (INIS)

    Depken, H.

    1976-01-01

    Reliability in service essential for many high-technology products fabricated today. This is particularly the case within the nuclear industry. Here defective materials or components may have diastrous consequences to the safety of human beings and the environment. A new concept - Quality Assurance - originates from this industry. The concept implies that all contractors, fabricators and material manufactures involved must prove that the quality control system used, fulfits particular requirements at all manufacturing, inspection and testing stages. These requirement are laid down in two standards issued by the U.S. Atomic Energy Commission and the American Society of Mechanical Engineers. These standards are discussed in the paper. As a manufacturer of steel products for nuclear applications Sandvik has been forced to establish a quality assurance system according to these principles. The Sandvik approach is briefly described with regard to organisation and other major quality assurance activities. Further the education and training of operators and technicians is touched upon. Finally some viewpoints regarding audits performed by customers of steel manufacturers are expressed. (author)

  8. Quality assurance during preoperational testing and during startup operation

    International Nuclear Information System (INIS)

    Eisele, H.; Meyer, F.A.

    1980-01-01

    Rules and guidelines for the quality assurance. Quality assurance in the course of preoperational testing and the startup period: preoperational testing; hot functional test I; hot functional test II; initial making critical and zero power physics testing; power range testing. Startup documents: startup program; startup instructions; startup data sheet; startup sequence outlines; final startup reports. Advisory safety committee for nuclear startup. (orig./RW)

  9. Quality assurance in radiodiagnosis

    International Nuclear Information System (INIS)

    Ghilardi Netto, T.; Sao Paulo Univ., Ribeirao Preto

    1983-01-01

    The following topics are dealt with: 1) the importance of the application of a quality assurance program in radiodiagnosis, with its main consequences : improvement of imaging quality, reduction of the patient expossure rate, cost reduction and 2) how to introduce the quality assurance control in the radiodiagnostic area. (M.A.) [pt

  10. Authentication Assurance Levels

    International Nuclear Information System (INIS)

    Kouzes, Richard T.; Cash, James R.; Devaney, David M.; Geelhood, Bruce D.; Hansen, Randy R.; Melton, Ronald B.; Pitts, W. Karl

    2002-01-01

    This Common Criteria approach has been applied to create a definition of Authentication Assurance Levels that can quantify the level of assurance reached for a system subject to a set of authentication procedures. The arms-control authentication application of the Common Criteria expands on more typical information security evaluations in that it must contend with information barriers and preclude sophisticated intentional subversion attempts.

  11. Quality assurance program

    International Nuclear Information System (INIS)

    Brooks, G.L.

    The concept of levels of quality assurance as applied to CANDU-type nuclear power plant components, i.e. maintaining an appropriate cost/benefit ratio, is introduced. The design process itself has quality assurance features by virtue of multi-level review. (E.C.B.)

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

    Science.gov (United States)

    Kobus, Thiele; Vykhodtseva, Natalia; Pilatou, Magdalini; Zhang, Yongzhi; McDannold, Nathan

    2016-02-01

    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 0.66 and 0.80 MPa, were performed under magnetic resonance guidance. The success and degree of BBB disruption was estimated by signal enhancement of post-contrast T1-weighted imaging of the treated area. Histopathological analysis was performed after the last treatment. The consequences of repeated BBB disruption varied from no indications of vascular damage to signs of micro-hemorrhages, macrophage infiltration, micro-scar formations and cystic cavities. The signal enhancement on the contrast-enhanced T1-weighted imaging had limited value for predicting small-vessel damage. T2-weighted imaging corresponded well with the effects on histopathology and could be used to study treatment effects over time. This study demonstrates that repeated BBB disruption by FUS can be performed with no or limited damage to the brain tissue. Copyright © 2016 World Federation for Ultrasound in Medicine & Biology. Published by Elsevier Inc. All rights reserved.

  13. [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.

  14. Laboratory quality assurance

    International Nuclear Information System (INIS)

    Delvin, W.L.

    1977-01-01

    The elements (principles) of quality assurance can be applied to the operation of the analytical chemistry laboratory to provide an effective tool for indicating the competence of the laboratory and for helping to upgrade competence if necessary. When used, those elements establish the planned and systematic actions necessary to provide adequate confidence in each analytical result reported by the laboratory (the definition of laboratory quality assurance). The elements, as used at the Hanford Engineering Development Laboratory (HEDL), are discussed and they are qualification of analysts, written methods, sample receiving and storage, quality control, audit, and documentation. To establish a laboratory quality assurance program, a laboratory QA program plan is prepared to specify how the elements are to be implemented into laboratory operation. Benefits that can be obtained from using laboratory quality assurance are given. Experience at HEDL has shown that laboratory quality assurance is not a burden, but it is a useful and valuable tool for the analytical chemistry laboratory

  15. Surveillance of Salmonella enteritidis in layer houses: a retrospective comparison of the Food and Drug Administration's egg safety rule (2010-2011) and the California Egg Quality Assurance Program (2007-2011).

    Science.gov (United States)

    Pitesky, Maurice; Charlton, Bruce; Bland, Mark; Rolfe, Dan

    2013-03-01

    Between July 2007 and December 2011, 2660 environmental drag swab samples were collected in total from California layer flocks on behalf of the California Egg Quality Assurance Program (CEQAP), the egg safety rule (21 CFR Parts 16 and 118) of the Food and Drug Administration (FDA), or both. The samples were processed by the California Animal Health and Food Safety Lab, and positive or negative results for Salmonella enterica serovar Enteritidis (SE) were recorded. This study retrospectively compares the differences between the FDA and CEQAP programs with respect to their SE environmental sampling surveillance results. To accomplish this comparison, two different CEQAP (new and old) data sets representing different SE environmental surveillance approaches in the life of the flock were compared against each other and against the FDA's SE environmental testing plan. Significant differences were noted between the CEQAP and FDA programs with respect to the prevalence of SE in the farm environment. Analyses of the prevalence of SE at different stages in the flock's life cycle (chick papers, preproduction, midproduction, postmolt, and premarket) found the highest prevalence of SE in premarket (11.9%), followed by postmolt (3.5%) and midproduction (3.4%), and there was a tie between chick papers and preproduction (2.1%). To assess the main effects of the presence of SE in the farm environment, backwards binary logistic regression was used. Of six independent variables examined (age of flock, year, season, owner, CEQAP membership, and analysis of pooled samples vs. individual swabs), only age of flock, owner, and year were determined to be significant factors in the final model. Although CEQAP membership and pooling vs. individuals swabs were not included in the final model, Pearson chi-square tests did show significantly higher odds of SE for non-CEQAP member farms and higher odds of SE in pooled samples vs. individual swabs.

  16. 10 CFR 72.142 - Quality assurance organization.

    Science.gov (United States)

    2010-01-01

    ... activities are performed, the organizational structure for executing the quality assurance program may take... the required authority and organizational freedom. Irrespective of the organizational structure, the... functions of structures, systems, and components which are important to safety. These activities include...

  17. Quality assurance manual for the development of digital systems

    International Nuclear Information System (INIS)

    Lee, Cheol Kwon; Kwon, Kee Choon; You, Young Eun; Kim, Kwan Hyun; Park, Jung Woo; Park, Chan Seok

    2001-12-01

    A digital safety system is being developed by three companies under the Korea Nuclear I and C System R and D Program. This Quality Assurance Manual (QAM) is written to ensure the safety and reliability of the system and to meet the regulatory requirements associated with quality assurance. This QAM describes eighteen elements of quality assurance criteria required for the development of the system, which are coincident with the criteria specified in Nuclear Energy Laws and Enforcement Regulations of Nuclear Energy Laws and 10CFR50 Appendix B. This QAM is submitted to the regulatory body with other documents related to the quality assurance activities performed during the system development. And its safety, validity and fulfillment are reviewed and audited in the review process of topical report of the digital safety system

  18. Quality assurance for gamma knives

    International Nuclear Information System (INIS)

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

    1995-09-01

    This report describes and summarizes the results of a quality assurance (QA) study of the Gamma Knife, a nuclear medical device used for the gamma irradiation of intracranial lesions. Focus was on the physical aspects of QA and did not address issues that are essentially medical, such as patient selection or prescription of dose. A risk-based QA assessment approach was used. Sample programs for quality control and assurance are included. The use of the Gamma Knife was found to conform to existing standards and guidelines concerning radiation safety and quality control of external beam therapies (shielding, safety reviews, radiation surveys, 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

  19. 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.

  20. Safety and efficacy of allogeneic umbilical cord red blood cell transfusion for children with severe anaemia in a Kenyan hospital: an open-label single-arm trial

    Science.gov (United States)

    Hassall, Oliver W; Thitiri, Johnstone; Fegan, Greg; Hamid, Fauzat; Mwarumba, Salim; Denje, Douglas; Wambua, Kongo; Mandaliya, Kishor; Maitland, Kathryn; Bates, Imelda

    2015-01-01

    Summary Background In sub-Saharan Africa, children are frequently admitted with severe anaemia needing an urgent blood transfusion, but blood is often unavailable. When conventional blood supplies are inadequate, allogeneic umbilical cord blood could be a feasible alternative. The aim of this study was to assess the safety and efficacy of cord blood transfusion in children with severe anaemia. Methods Between June 26, 2007, and May 20, 2008, 413 children needing an urgent blood transfusion were admitted to Kilifi District Hospital in Kenya. Of these, 87 children were eligible for our study—ie, younger than 12 years, no signs of critical illness, and haemoglobin 100 g/L or lower (if aged 3 months or younger) or 40 g/L or lower (if older than 3 months). Cord blood was donated at Coast Provincial General Hospital, Mombasa, and screened for transfusion-transmitted infections and bacterial contamination. Red blood cells were stored vertically at 2–6°C to enable sedimentation. After transfusion, children were monitored closely for adverse events and followed up for 28 days. The primary outcome measure was the frequency and nature of adverse reactions associated with the transfusion. Secondary outcomes were the changes in haemoglobin concentrations 24 h and 28 days after transfusion, compared with pretransfusion levels. This trial is registered on ISRCTN.com, number ISRCTN66687527. Findings Of the 87 children eligible for the study, cord blood was unavailable for 24, six caregivers declined consent, and two children were withdrawn before transfusion. Therefore, 55 children received umbilical cord red blood cells from 74 donations. Ten (18%) children had ten serious adverse events and 43 (78%) had 94 adverse events; the most frequent adverse events were anaemia (n=14), weight loss (n=12), and vomiting (n=10). An independent expert panel judged none of these adverse events to be probably or certainly caused by the cord blood transfusion (one-sided 97·5% CI 0–6·5

  1. Safety and efficacy of allogeneic umbilical cord red blood cell transfusion for children with severe anaemia in a Kenyan hospital: an open-label single-arm trial.

    Science.gov (United States)

    Hassall, Oliver W; Thitiri, Johnstone; Fegan, Greg; Hamid, Fauzat; Mwarumba, Salim; Denje, Douglas; Wambua, Kongo; Mandaliya, Kishor; Maitland, Kathryn; Bates, Imelda

    2015-03-01

    In sub-Saharan Africa, children are frequently admitted with severe anaemia needing an urgent blood transfusion, but blood is often unavailable. When conventional blood supplies are inadequate, allogeneic umbilical cord blood could be a feasible alternative. The aim of this study was to assess the safety and efficacy of cord blood transfusion in children with severe anaemia. Between June 26, 2007, and May 20, 2008, 413 children needing an urgent blood transfusion were admitted to Kilifi District Hospital in Kenya. Of these, 87 children were eligible for our study--ie, younger than 12 years, no signs of critical illness, and haemoglobin 100 g/L or lower (if aged 3 months or younger) or 40 g/L or lower (if older than 3 months). Cord blood was donated at Coast Provincial General Hospital, Mombasa, and screened for transfusion-transmitted infections and bacterial contamination. Red blood cells were stored vertically at 2-6°C to enable sedimentation. After transfusion, children were monitored closely for adverse events and followed up for 28 days. The primary outcome measure was the frequency and nature of adverse reactions associated with the transfusion. Secondary outcomes were the changes in haemoglobin concentrations 24 h and 28 days after transfusion, compared with pretransfusion levels. This trial is registered on ISRCTN.com, number ISRCTN66687527. Of the 87 children eligible for the study, cord blood was unavailable for 24, six caregivers declined consent, and two children were withdrawn before transfusion. Therefore, 55 children received umbilical cord red blood cells from 74 donations. Ten (18%) children had ten serious adverse events and 43 (78%) had 94 adverse events; the most frequent adverse events were anaemia (n=14), weight loss (n=12), and vomiting (n=10). An independent expert panel judged none of these adverse events to be probably or certainly caused by the cord blood transfusion (one-sided 97·5% CI 0-6·5). Haemoglobin increased by a median of 26 g

  2. DOE financial assurance presentation

    International Nuclear Information System (INIS)

    Huck, R.

    1990-01-01

    The presentation topic is California's approach to license application review in meeting financial assurances for the proposed Ward Valley site. The purpose of the presentation is to provide information on specific financial assurance provisions contained in 10 CFR Part 61 and how California intends to satisfy those requirements. Also, as rate setter, California intends to demonstrate how it will assure allowable costs to the rate base though a financial prudency review. The key provisions of financial assurance are: 10 CFR Section 61.61 - This provision requires an applicant to demonstrate its ability to finance licensed activities; 10 CFR Section 61.62 - This provision requires an applicant to provide assurance that sufficient funds will be available for site closure and stabilization; and 10 CFR Section 61.63 - This provision requires an applicant to provide 'a copy of a binding arrangement, such as a lease, between the applicant and the disposal site owner, so that sufficient funds will be available to cover the costs of the institutional control period.' To assist California in its determination of financial assurance compliance to be demonstrated by the applicant for Part 61 requirements, is NUREG guidance document 1199 'Standard Format and Content of a License Application for a Low-Level Radioactive Waste (LLRW) Disposal Facility.' The detailed financial assurance provisions of NUREG 1199 are then embodied in NUREG 1200, 'Standard Review Plant for the Review of a License Application for a LLRW Disposal Facility.'

  3. 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.

  4. Metrics design for safety assessment

    NARCIS (Netherlands)

    Luo, Yaping; van den Brand, M.G.J.

    2016-01-01

    Context:In the safety domain, safety assessment is used to show that safety-critical systems meet the required safety objectives. This process is also referred to as safety assurance and certification. During this procedure, safety standards are used as development guidelines to keep the risk at an

  5. Repository construction management and quality assurance

    International Nuclear Information System (INIS)

    Hood, F.C.

    1984-01-01

    An emphasis on preventive rather than reactive management is key to an efficient construction management operation. Development of contingency plans to deal with unexpected adverse conditions, e.g., brine pockets during mining operations, are an integral part of the management program to ensure project safety, quality, cost, schedule and environmental objectives are met. A viable quality assurance program with active management support will optimize management effectiveness in reaching project goals. With adequate planning and perceptive application of the proper management controls, Quality Assurance becomes an essential ingredient for efficiently managing a job because it has been built into the management system rather than being an uninvolved peripheral entity. 6 references, 3 figures

  6. 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).

  7. Quality assurance in the manufacture of pressure components

    International Nuclear Information System (INIS)

    Knoedler, D.

    1979-01-01

    New regulations for nuclear power plants emphasize more quality assurance than it was the case in the past. Quality assurance is a management tool. During erection the quality assurance measures of the manufacturer, the main contractor and the required quality and the reliability of the proof of quality. The qualification of processes, equipment and personnel is a significant measure of quality assurance. The proof for quality assurance to be effective needs not only system-oriented audits, but also product audits aimed at quality characteristics of the product itself. The existing problems of examination techniques not optimized according to latest experience and of the large volume of documetation will persist in case the existing regulations are not adjusted according to the results of relevant studies. Furthermore the effectiveness of quality assurance is too often hampered by vague definitions of the safety objectives. (orig.) [de

  8. Application of project design peer review to improve quality assurance

    International Nuclear Information System (INIS)

    McClure, F.E.

    1989-01-01

    DOE ORDER 5481.1B Safety Analysis and Review Systems and DOE ORDER 6430.1A General Design Criteria require that the design of facilities shall incorporate the necessary Quality Assurance review requirements to assure that the established program quality assurance objectives are met in the design criteria and the construction documents. The use of Project Design Peer Review to satisfy these requirements is presented. The University of California manages the Lawrence Berkeley Laboratory, the Lawrence Livermore National Laboratory, and the Los Alamos National Scientific Laboratory. The 1988 University Seismic Safety Policy requires the use of independent Project Design Peer Review in its capital improvement and seismic reconstruction program

  9. prevalence of cytomegalovirus antibodies in blood donors

    African Journals Online (AJOL)

    2009-12-02

    Dec 2, 2009 ... blood products, or by transfusion of leucodepleted blood products. Objective: To determine the .... 2005; 6: 67-84. 6. Strasbourg, G. Guide to the preparation, use and quality assurance of blood components 13th edition. 2007 ...

  10. Research on quality assurance classification methodology for domestic AP1000 nuclear power projects

    International Nuclear Information System (INIS)

    Bai Jinhua; Jiang Huijie; Li Jingyan

    2012-01-01

    To meet the quality assurance classification requirements of domestic nuclear safety codes and standards, this paper analyzes the quality assurance classification methodology of domestic AP1000 nuclear power projects at present, and proposes the quality assurance classification methodology for subsequent AP1000 nuclear power projects. (authors)

  11. Quality assurance and management

    International Nuclear Information System (INIS)

    Newcomb, W.E.

    1989-01-01

    This paper traces the evolution of the quality assurance program of an office of waste management development (OWTD). The program's needs and commitment are examined. The author reports on the role of program and technical managers in such a program

  12. 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.

  13. 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.

  14. Quality assurance in radiotherapy

    International Nuclear Information System (INIS)

    Groth, S.; Meghzifene, A.; Tatsuzaki, H.; Levin, V.; Izewska, J.

    2001-01-01

    Quality assurance in the management of a patient receiving radiation therapy and the role of the radiation oncologist and medical physicist in this process is described. The constraints on available personnel are recognised and the need for further education resources and IAEA activities in education for both groups described. IAEA activities in the clinical and dosimetric aspects and the resultant publications and education have contributed to a culture of quality assurance. (author)

  15. Quality assurance in NDT

    International Nuclear Information System (INIS)

    Krishnamoorthy, K.

    2010-01-01

    The importance of Nondestructive Testing (NDT) as a Quality Control/Quality Assurance tool in the industrial domain cannot be over-emphasized. With the rapid advancement in research and technology, the NDT field is becoming larger and more sophisticated day by day. Innovative research in materials science and digital technology is paving the way for more and more new methods in NDT technology. Although the NDT technology has improved over the years, the basic 'human factor' underlying the success of the NDT field remains the same. There are two major factors that influence the 'Quality Assurance in NDT'. First, knowledgeable and skilled NDT Operators are the most important factor in assuring the reliable test results. Second, the Management oversight of the NDT operations plays a major role in assuring the overall quality of NDT. Management responsibilities include the implementation of a Quality Management System (QMS) that focuses on the NDT operations and apply all the elements of Quality Assurance relevant to NDT. Whether the NDT operations are performed in-house or by a contractor, periodic Management Self-assessments should include the following question: How can the Management assess and improve the 'Quality Assurance in NDT'? This paper attempts to answer the above question. Some practical examples are provided to illustrate the potential quality incidents that could lead to costly failures, and the role of NDT Operator and the Management in preventing such quality incidents. Also, some guidelines are provided on how the Management can apply the elements of Quality Assurance to NDT in order to assess and improve the 'Quality Assurance in NDT'. (author)

  16. SAFETY

    CERN Multimedia

    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...

  17. 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...

  18. Human immunodeficiency virus prevalence, incidence, and residual transmission risk in first-time and repeat blood donations in Zimbabwe : implications on blood safety

    NARCIS (Netherlands)

    Mapako, Tonderai; Mvere, David A.; Chitiyo, McLeod E.; Rusakaniko, Simbarashe; Postma, Maarten J.; Van Hulst, Marinus

    2013-01-01

    BACKGROUND: National Blood Service Zimbabwe human immunodeficiency virus (HIV) risk management strategy includes screening and discarding of first-time donations, which are collected in blood packs without an anticoagulant (dry pack). To evaluate the impact of discarding first-time donations on

  19. [The francophone Africa blood transfusion research network: a five-year report].

    Science.gov (United States)

    Tagny, Claude Tayou; Murphy, Edward L; Lefrère, Jean-Jacques

    2014-03-01

    There has been little blood safety research in sub-Saharan Africa, often consisting of local efforts whose findings had limited impact The "Francophone Africa Transfusion Research Network" was created in May 2007 with the objective of developing common evidence-based blood safety policies that may be adapted to each country's situation. The Group's activities to date have focused mainly on obtaining epidemiological and laboratory data on blood transfusion and on suggesting blood safety strategies, particularly in the field of TTIs. To carry out such research activities, the group works closely with the National Blood Transfusion Services (NBTS), the Regional Blood Transfusion Services (RBTS), the hospital blood banks (HBB) and collection stations. For the first 5years, four research priorities were identified: (i) descriptive studies of the characteristics of francophone African blood donors and blood centers; (ii) estimation of the residual risk of transfusion-transmitted major viral infections; (iii) an analysis of blood donor deferral strategies; and (iv) a description of TTI screening strategies and an external quality assurance system (EQAS) project. During this period, seven projects have been implemented at the national level and published and five multicenter studies were conducted and published. The present review reports the main observations and recommendations from those studies that could improve blood safety statute in Africa. Copyright © 2013. Published by Elsevier SAS.

  20. Phase 2 sampling and analysis plan, Quality Assurance Project Plan, and environmental health and safety plan for the Clinch River Remedial Investigation: An addendum to the Clinch River RCRA Facility Investigation plan

    Energy Technology Data Exchange (ETDEWEB)

    Cook, R.B.; Adams, S.M.; Beauchamp, J.J.; Bevelhimer, M.S.; Blaylock, B.G.; Brandt, C.C.; Etnier, E.L.; Ford, C.J.; Frank, M.L.; Gentry, M.J.; Greeley, M.S.; Halbrook, R.S.; Harris, R.A.; Holladay, S.K.; Hook, L.A.; Howell, P.L.; Kszos, L.A.; Levine, D.A.; Skiles, J.L.; Suter, G.W.

    1992-12-01

    This document contains a three-part addendum to the Clinch River Resource Conservation and Recovery Act (RCRA) Facility Investigation Plan. The Clinch River RCRA Facility Investigation began in 1989, as part of the comprehensive remediation of facilities on the US Department of Energy Oak Ridge Reservation (ORR). The ORR was added to the National Priorities List in December 1989. The regulatory agencies have encouraged the adoption of Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) terminology; therefore, the Clinch River activity is now referred to as the Clinch River Remedial Investigation (CRRI), not the Clinch River RCRA Facility Investigation. Part 1 of this document is the plan for sampling and analysis (S A) during Phase 2 of the CRRI. Part 2 is a revision of the Quality Assurance Project Plan for the CRRI, and Part 3 is a revision of the Environmental Health and Safety Plan for the CRRI. The Clinch River RI (CRRI) is designed to address the transport, fate, and distribution of waterborne contaminants (radionuclides, metals, and organic compounds) released from the DOE Oak Ridge Reservation (ORR) and to assess potential risks to human health and the environment associated with these contaminants. Primary areas of investigation are Melton Hill Reservoir, the Clinch River from Melton Hill Dam to its confluence with the Tennessee River, Poplar Creek, and Watts Bar Reservoir. The contaminants identified in the Clinch River/Watts Bar Reservoir (CR/WBR) downstream of the ORR are those associated with the water, suspended particles, deposited sediments, aquatic organisms, and wildlife feeding on aquatic organisms. The purpose of the Phase 2 S A Plan is to describe the proposed tasks and subtasks developed to meet the primary objectives of the CRRI.

  1. Phase 2 sampling and analysis plan, Quality Assurance Project Plan, and environmental health and safety plan for the Clinch River Remedial Investigation: An addendum to the Clinch River RCRA Facility Investigation plan

    International Nuclear Information System (INIS)

    Cook, R.B.; Adams, S.M.; Beauchamp, J.J.; Bevelhimer, M.S.; Blaylock, B.G.; Brandt, C.C.; Etnier, E.L.; Ford, C.J.; Frank, M.L.; Gentry, M.J.; Greeley, M.S.; Halbrook, R.S.; Harris, R.A.; Holladay, S.K.; Hook, L.A.; Howell, P.L.; Kszos, L.A.; Levine, D.A.; Skiles, J.L.; Suter, G.W.

    1992-12-01

    This document contains a three-part addendum to the Clinch River Resource Conservation and Recovery Act (RCRA) Facility Investigation Plan. The Clinch River RCRA Facility Investigation began in 1989, as part of the comprehensive remediation of facilities on the US Department of Energy Oak Ridge Reservation (ORR). The ORR was added to the National Priorities List in December 1989. The regulatory agencies have encouraged the adoption of Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) terminology; therefore, the Clinch River activity is now referred to as the Clinch River Remedial Investigation (CRRI), not the Clinch River RCRA Facility Investigation. Part 1 of this document is the plan for sampling and analysis (S ampersand A) during Phase 2 of the CRRI. Part 2 is a revision of the Quality Assurance Project Plan for the CRRI, and Part 3 is a revision of the Environmental Health and Safety Plan for the CRRI. The Clinch River RI (CRRI) is designed to address the transport, fate, and distribution of waterborne contaminants (radionuclides, metals, and organic compounds) released from the DOE Oak Ridge Reservation (ORR) and to assess potential risks to human health and the environment associated with these contaminants. Primary areas of investigation are Melton Hill Reservoir, the Clinch River from Melton Hill Dam to its confluence with the Tennessee River, Poplar Creek, and Watts Bar Reservoir. The contaminants identified in the Clinch River/Watts Bar Reservoir (CR/WBR) downstream of the ORR are those associated with the water, suspended particles, deposited sediments, aquatic organisms, and wildlife feeding on aquatic organisms. The purpose of the Phase 2 S ampersand A Plan is to describe the proposed tasks and subtasks developed to meet the primary objectives of the CRRI

  2. 12: Assuring the quality of critical software

    International Nuclear Information System (INIS)

    Jacky, J.; Kalet, I.

    1987-01-01

    The authors recommend quality assurance procedures for radiation therapy software. Software quality assurance deals with preventing, detecting and repairing programming errors. Error detection difficulties are most severe in computer-based control systems, for example therapy machine control systems, because it may be impossible for users to confirm correct operation while treatments are in progress, or to intervene if things go wrong. Software quality assurance techniques observed in other industries in which public safety is at risk are reviewed. In some of these industries software must be approved or certified before it can be used. Approval is subject to technical reviews and audits by experts other than the program authors. The main obstacles to adoption of these techniques in the radiation therapy field are costs, lack of familiarity and doubts regarding efficacy. 18 refs

  3. Current conceptions of industrial quality assurance

    International Nuclear Information System (INIS)

    Zeller, H.

    1978-01-01

    In the electrical engineering industry quality assurance is mainly oriented in accordance with the customers', users', and consumers' requirements concerning the quality of products (including reliability). These requirements are as manifold as the range of products itself. They do not only comprise functional criteria, but also safety against malfunctions, bodily injury or property damage. Quality assurance is embedded in the overall activities of a company; the peripheral conditions, such as organization, profitability, qualification, and responsibility of staff have to be considered. Thus, quality assurance in the electrical engineering industry proceeds in efficient systems which are adapted to the individual forms of production. These systems may include planning, testing, feedback of quality data, statistical procedures, costs and profitability. Their obvious interaction is based on the system of coordinates of integrated quality control. The paper will illustrate the basic features of this interaction by reference to various examples. (orig.) [de

  4. The NASA Commercial Crew Program (CCP) Mission Assurance Process

    Science.gov (United States)

    Canfield, Amy

    2016-01-01

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

  5. Safety

    International Nuclear Information System (INIS)

    Jones, P.M.S.

    1987-01-01

    Aspects of fission reactors are considered - control, heat removal and containment. Brief descriptions of the reactor accidents at the SL-1 reactor (1961), Windscale (1957), Browns Ferry (1975), Three Mile Island (1979) and Chernobyl (1986) are given. The idea of inherently safe reactor designs is discussed. Safety assessment is considered under the headings of preliminary hazard analysis, failure mode analysis, event trees, fault trees, common mode failure and probabalistic risk assessments. These latter can result in a series of risk distributions linked to specific groups of fault sequences and specific consequences. A frequency-consequence diagram is shown. Fatal accident incidence rates in different countries including the United Kingdom for various industries are quoted. The incidence of fatal cancers from occupational exposure to chemicals is tabulated. Human factors and the acceptability of risk are considered. (U.K.)

  6. Floating nuclear power plant safety assurance principles

    International Nuclear Information System (INIS)

    Zvonarev, B.M.; Kuchin, N.L.; Sergeev, I.V.

    1993-01-01

    In the north regions of the Russian federation and low density population areas, there is a real necessity for ecological clean energy small power sources. For this purpose, floating nuclear power plants, designed on the basis of atomic ship building engineering, are being conceptualized. It is possible to use the ship building plants for the reactor purposes. Issues such as radioactive waste management are described

  7. The challenge of Quality Assurance

    International Nuclear Information System (INIS)

    Simon, R.; Price, M.S.T.; Krischer, W.

    1985-01-01

    The safe terminal containment of hazardous wastes cannot only rely upon the geographic remoteness and the arid climates of the repository sites. Radioactive and permanently toxic chemical wastes must by prevented from returning to the human environment by natural and engineered barriers. The long-term integrity of these barriers and the safety of waste emplacement operation will be controlled by systematic actions under the common objective of Quality Assurance (QA). The following paper presents the aims of QA in the design and production of waste packages. It lists the most relevant acceptance criteria and regulatory requirements, investigates the institutional and technical problems of carrying out Quality Assurance and presents suggestions for establishing suitable organizational structures and technical programmes to provide adequate confidence in the safe nature and the performance of waste packages. In view of the technical difficulties of verifying the compliance of industrially produced waste forms with the acceptance criteria, the CEC has laid emphasis on the development of appropriate test methods in its last R and D programme. First results of the work are reviewed in the context of international progress in this field

  8. Safety of blood supply in the Caribbean countries: role of screening blood donors for markers of hepatitis B and C viruses.

    Science.gov (United States)

    Cruz, Jose R; Pérez-Rosales, Maria Dolores; Zicker, Fabio; Schmunis, Gabriel A

    2005-12-01

    Blood transfusions carry risks of untoward reactions, including the transmission of infections, such as hepatitis B and C. Proper blood donor recruitment and selection, and adequate laboratory screening for infectious markers diminish the risk of transfusion-transmitted infections. To estimate the potential risk of acquiring transfusion-transmitted infections by hepatitis B or hepatitis C in 24 Caribbean countries during the period of 1996 to 2003. Official national reports for 1996, 2000-2003 of the yearly number of blood donors, screening coverage, and prevalence of serological markers for infectious diseases were used to estimate the risk of patients receiving an HBV- or HCV-positive unit of blood, and of developing an infection after receiving a positive unit. Estimates of number of infections transmitted through transfusion and number of infections prevented by screening of blood were also obtained. During the period analyzed, HBV screening coverage among blood donors was 100% in all countries with the exception of Grenada (0% in 1996) and Saint Lucia (99.5% in 2002). For HCV, only 10 countries reported universal screening in 1996, while 15 did in 2003. The number of countries that did not screen any units for HCV decreased from 11 in 1996 to five in 2003. In general, high prevalence rates of HBV (10-75 per 1000 donors) and HCV (7-19.3 per 1000 donors) markers were found in the majority of countries. We estimated that 235 infections by HCV (1:12471 donations) and two infections by HBV (1:1465373) were transmitted through transfusion because of lack of screening. On the other hand, screening of blood for transfusion prevented 21 005 HCV and 22 100 HBV infections. Blood donor recruitment and coverage of screening for transfusion-transmitted infections, especially HCV, must be improved in the Caribbean countries.

  9. Quality assurance and product quality

    International Nuclear Information System (INIS)

    Lacroix, D.; Bastiani, P. de

    2004-01-01

    The basic quality assurance requirements have to be completed by means that are oriented towards the quality of products; in COGEMA LOGISTICS our approach is based on four principles: 1) an integrated management system: Quality, health and safety, environment 2) an organization based on the responsibility of all actors, trust and transparency 3) a methodical approach to continuously improve the methods that are employed to achieve quality: -process management -corrective and preventive actions -self assessments and various surveys 4) but at the same time strong procedures for control and monitoring of all activities: -technical and quality audits (external and internal) -at source inspections -engineering activities inspections This performance-based approach is necessary to guaranty the effectiveness of the traditional formal QA means

  10. Review of SKB's Quality Assurance Programme

    International Nuclear Information System (INIS)

    Baldwin, Tamara D.; Hicks, Timothy W.

    2009-06-01

    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 licence

  11. The donor line break cannula: effect on the donation process, blood component quality and transfusion microbiology testing of an important new blood bag safety feature.

    Science.gov (United States)

    Nightingale, M J; Beard, M J; Bennett, J; Hambleton, R; Ramskill, S; Thomas, S

    2013-08-01

    The use of blood packs with an integral sampling system can result in anti-coagulant from the main bag reaching the sample pouch via the donor line, causing delayed coagulation of blood samples. In NHS Blood and Transplant, this has prevented the use of serum, the preferred matrix for transfusion microbiology (TM) testing, which has led to an increased false positive rate with ethylenediaminetetraacetic acid (EDTA) plasma. There is also a remote possibility of false negative results owing to sample dilution. Manufacturers have responded by offering packs with a donor line break cannula (DLBC) to prevent these adverse effects. The aims of this study were to assess the impact of DLBC packs on donation, blood component quality and of the potential return to serum for TM testing. DLBC packs from three manufacturers were assessed against control packs of the same dimensions and configuration. Donation duration, flow rate, platelet factor 4, prothrombin fragment 1+2, haemolysis and collection and processing incidents were compared. Results indicated no clinically significant adverse effect from the DLBC on the activation state of platelets, the coagulation cascade or increased haemolysis. Donation duration and blood collection and processing incident rates for DLBC packs were not significantly different to controls. The use of DLBC packs would reduce the complexity of manipulations during blood collection and therefore the likelihood of microbially contaminated donations (incorrect skin core diversion) and false negative TM tests. DLBC packs would enable the use of serum for TM testing with a significant reduction in false positive tests compared to EDTA plasma. © 2013 The Authors. Transfusion Medicine © 2013 British Blood Transfusion Society.

  12. Quality assurance of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Frier, M.; Hesslewood, S.R.

    1980-01-01

    A practical guide has been composed for all persons involved in the preparation and use of radiopharmaceuticals on methods used in quality assurance and their applications. These methods include the calibration of ionization chamber assay calibrators, the determination of radionuclide purity, radiochemical purity and chemical purity, particle size analysis and the measurement of pH. Quality assurance procedures are described for products not described in Compendial Monographs, or where the monograph exists, additional useful information is provided; such radiopharmaceuticals include technetium, indium-labelled and iodine-labelled products. (U.K.)

  13. Software quality assurance

    CERN Document Server

    Laporte, Claude Y

    2018-01-01

    This book introduces Software Quality Assurance (SQA) and provides an overview of standards used to implement SQA. It defines ways to assess the effectiveness of how one approaches software quality across key industry sectors such as telecommunications, transport, defense, and aerospace. * Includes supplementary website with an instructor's guide and solutions * Applies IEEE software standards as well as the Capability Maturity Model Integration for Development (CMMI) * Illustrates the application of software quality assurance practices through the use of practical examples, quotes from experts, and tips from the authors

  14. 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...Assurance PRM, RMM, Assurance for CMMI)) – Lifecycle Processes ( ISO /IEEE 15288, ISO /IEEE 12207) – COBIT, ITIL, MS SDL, OSAMM, BSIMM 5 The egg...a.k.a Product Focused Assessments) – SCAP - NIST-SCAP – ISO /OMG W3C – KDM, BPMN, RIF, XMI, RDF – OWASP Top 10 – SANS TOP 25 – Secure Code Check Lists

  15. Nuclear fuel quality assurance

    International Nuclear Information System (INIS)

    1976-01-01

    Full text: Quality assurance is used extensively in the design, construction and operation of nuclear power plants. This methodology is applied to all activities affecting the quality of a nuclear power plant in order to obtain confidence that an item or a facility will perform satisfactorily in service. Although the achievement of quality is the responsibility of all parties participating in a nuclear power project, establishment and implementation of the quality assurance programme for the whole plant is a main responsibility of the plant owner. For the plant owner, the main concern is to achieve control over the quality of purchased products or services through contractual arrangements with the vendors. In the case of purchase of nuclear fuel, the application of quality assurance might be faced with several difficulties because of the lack of standardization in nuclear fuel and the proprietary information of the fuel manufacturers on fuel design specifications and fuel manufacturing procedures. The problems of quality assurance for purchase of nuclear fuel were discussed in detail during the seminar. Due to the lack of generally acceptable standards, the successful application of the quality assurance concept to the procurement of fuel depends on how much information can be provided by the fuel manufacturer to the utility which is purchasing fuel, and in what form and how early this information can be provided. The extent of information transfer is basically set out in the individual vendor-utility contracts, with some indirect influence from the requirements of regulatory bodies. Any conflict that exists appears to come from utilities which desire more extensive control over the product they are buying. There is a reluctance on the part of vendors to permit close insight of the purchasers into their design and manufacturing procedures, but there nevertheless seems to be an increasing trend towards release of more information to the purchasers. It appears that

  16. Quality assurance inspections in the transportation packaging supplier industry

    International Nuclear Information System (INIS)

    Jankovich, J.P.

    1991-01-01

    In this paper the quality assurance inspections of the transportation packaging supplier industry, conducted by the U.S. Nuclear Regulatory Commission (NRC) on a routine basis since 1989 are discussed. The term supplier is used to include designers, fabricators, and distributors that hold NRC approved Quality Assurance Programs and Certificates of Compliance for packagings to transport radioactive materials. The objective of the inspections is to provide assurance that transportation packagings are fabricated and procured in accordance with 10 CFR Parts 21 and 71 requirements. The inspections are conducted in a systematic and comprehensive manner, utilizing uniform inspection techniques in order to assure uniformity and comparability. During the April 1989 and May 1991 period approximately 21 inspections were conducted by the Transportation Branch, Office of Nuclear Material Safety and Safeguards of the NRC. The majority of the findings were identified in the areas of quality assurance procedures, control of special processes (e.g. welding, radiography), and maintenance of QA records

  17. AVLIS Production Plant Preliminary Quality Assurance Plan and Assessment

    International Nuclear Information System (INIS)

    1984-01-01

    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

  18. Defining Baconian Probability for Use in Assurance Argumentation

    Science.gov (United States)

    Graydon, Patrick J.

    2016-01-01

    The use of assurance cases (e.g., safety cases) in certification raises questions about confidence in assurance argument claims. Some researchers propose to assess confidence in assurance cases using Baconian induction. That is, a writer or analyst (1) identifies defeaters that might rebut or undermine each proposition in the assurance argument and (2) determines whether each defeater can be dismissed or ignored and why. Some researchers also propose denoting confidence using the counts of defeaters identified and eliminated-which they call Baconian probability-and performing arithmetic on these measures. But Baconian probabilities were first defined as ordinal rankings which cannot be manipulated arithmetically. In this paper, we recount noteworthy definitions of Baconian induction, review proposals to assess confidence in assurance claims using Baconian probability, analyze how these comport with or diverge from the original definition, and make recommendations for future practice.

  19. 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...

  20. Quality assurance. 6. ed.

    International Nuclear Information System (INIS)

    Masing, W.

    1979-01-01

    Brief introduction to the quality sector. After some explanations of the terms of quality, feature, and defect, the article discusses the planning of quality and testing, industrial metrology, the test risk, quality assurance, quality enhancement, quality cost, and organisational problems. (RW) [de

  1. 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.

  2. [Integrated quality assurance].

    Science.gov (United States)

    Bögel, K; Stöhr, K

    1994-07-01

    The definition of terms and connotation of "Quality", "Quality Assurance" and "Integration" lead to an analysis and understanding of inhibiting and fostering factors of the "Health Triad" of people, animals and environment. Although "Quality" is largely or ultimately determined by the consumer, there are considerable differences as this term is applied by (a) the individual consumer, (b) the dynamic producer defending or gaining markets, (c) those engaged in traditional product manufacturing, or (d) governments setting (minimum) requirements for the sake of free trade. "Quality Assurance" offers cooperation of partners all along the food chain from "pasture to table". The managerial process turned into a continuum of responsibility and agreement on processes and product characteristics. This overcomes the disadvantages of strategies stressing distinct defense barriers. In practice this philosophy of a predominant role of defence barriers proved largely partnership destructive, in that it permitted to shift responsibilities for failures and to claim administrative competence according to momentary situations and interests. "Integrated Quality Assurance" means mutual agreement of two or more partners along the food chain (e. g. feed producers, farmers, animal health industry, veterinarians and food processors) on product characteristics and production methods. It involves essential system elements including facilities, materials, manpower, information, transport, management etc. Different principles and procedures of quality assurance have been introduced in practice, including agriculture and food processing. These different approaches are not mutually exclusive but largely of complementary nature.(ABSTRACT TRUNCATED AT 250 WORDS)

  3. 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

  4. 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.

  5. General safety considerations

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-09-01

    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.

  6. General safety considerations

    International Nuclear Information System (INIS)

    2001-01-01

    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

  7. General safety considerations

    International Nuclear Information System (INIS)

    1998-01-01

    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

  8. 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...

  9. Safety strategy

    International Nuclear Information System (INIS)

    Schultheiss, G.F.

    1980-01-01

    The basis for safety strategy in nuclear industry and especially nuclear power plants is the prevention of radioactivity release inside or outside of the technical installation. Therefore either technical or administrative measures are combined to a general strategy concept. This introduction will explain in more detail the following topics: - basic principles of safety - lines of assurance (LOA) - defense in depth - deterministic and probabilistic methods. This presentation is seen as an introduction to the more detailed discussion following in this course, nevertheless some selected examples will be used to illustrate the aspects of safety strategy development although they might be repeated later on. (orig.)

  10. 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...

  11. Physical aspects of quality assurance in cobalt teletherapy units

    Energy Technology Data Exchange (ETDEWEB)

    Ng, Kwan Hong [Malaya Univ., Kuala Lumpur (Malaysia)

    1989-06-01

    ICRU Report No. 24 states that +- 5% is a reasonable degree of accuracy to strive for in the delivery of absorbed doses to target volumes in radiotherapy. To achieve this quality assurance level, a comprehensive programme comprising both physical and clinical components is needed. The purpose of this paper is to present the rationale and guidelines for implementing a recommended quality assurance programme. It will emphasize the physical aspects pertaining to acceptance and constancy tests using Cobalt-60 teletherapy units. It will also outline a suggested schedule of quality assurance testings including radiation dosimetry, geometry and electrochemical safety. (author).

  12. Quality assurance program preparation - review of requirements and plant systems - selection of program levels

    International Nuclear Information System (INIS)

    Asmuss, G.

    1980-01-01

    The establishment and implementation for a practicable quality assurance program for a nuclear power plant demands a detailed background in the field of engineering, manufacturing, organization and quality assurance. It will be demonstrated with examples to define and control the achievement of quality related activities during the phases of design, procurement, manufactoring, commissioning and operation. In general the quality assurance program applies to all items, processes and services important to safety of nuclear power plant. The classification for safety related and non-safety related items and services demonstrate the levels of quality assurance requirements. The lecture gives an introduction of QA Program preparation under the following topics: -Basic criteria and international requirements - Interaction of QA activities - Modular and product oriented QA programs - Structuring of organization for the QA program - Identification of the main quality assurance functions and required actions - Quality Assurance Program documentation - Documentation of planning of activities - Control of program documents - Definitions. (orig./RW)

  13. Blood alcohol test results of motor vehicle deaths as an evaluation method for the Fairfax Alcohol Safety Action Project.

    Science.gov (United States)

    1973-01-01

    The Fairfax Alcohol Safety Action Project (ASAP) was started following the June 1971 approval of the proposal and working plan submitted to the Department of Transportation by the Highway Safety Division of Virginia. A total of $2,123,000 was allocat...

  14. 49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false Will a safety audit result in a safety fitness... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.317 Will a safety audit result in a safety fitness determination by the FMCSA? A safety audit will not result in a safety...

  15. Tainted blood

    DEFF Research Database (Denmark)

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

    2015-01-01

    The existing literature on donor screening in transfusion medicine tends to distinguish between social concerns about discrimination and medical concerns about safety. In this article, we argue that the bifurcation into social and medical concerns is problematic. We build our case on a qualitative...... 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...

  16. The development of quality assurance program in Reactor TRIGA PUSPATI (RTP)

    International Nuclear Information System (INIS)

    Rosli Darmawan; Mohd Rizal Mamat; Mohamad Zaid Mohamad; Mohd Ridzuan Abdul Mutalib

    2007-01-01

    One of the trivial issues in the operation of Nuclear Reactor is the safety of the system. Worldwide publicity on a few nuclear accidents as well as the notorious Hiroshima and Nagasaki bombing has always bring about general public fear on anything related to nuclear. IAEA has always emphasized on the assurance of nuclear safety for all nuclear installations and activities. According to the IAEA safety guides, all research reactors are required to implement quality assurance programs to ensure the conduct of operations are in accordance with the safety standards required. This paper discusses the activities carried out toward the establishment of Quality Assurance Program for Reaktor TRIGA PUSPATI (RTP). (Author)

  17. Effects and safety of daily ingestion of plum extract on blood pressure: randomized, double-blinded, placebo-controlledparallelgroup comparison study

    Directory of Open Access Journals (Sweden)

    Mie Nishimura

    2017-11-01

    Full Text Available Background: Hypertension is an increasing health issue in Japan. Plums are widely consumed in Japan and are reported to have various health benefits, including improvements to blood flow. However, clinical trials investigating the effects of plum extract on blood pressure have not yet been conducted. Therefore, we evaluated the effects and safety of plum extract on blood pressure in this randomized, double-blinded, and placebo-controlled parallel group comparison study. Methods: Seventy-four healthy Japanese subjects with systolic blood pressure (SBP ≥130 and <160 mmHg were randomly divided into test and placebo groups. Subjects were given either plum extract-processed food (3.0 g of plum extract, containing 30 mg of mumefural and 1.119 g of citric acid or placebo food daily for 12 weeks. Physical examinations, blood measurements, and medical interviews were performed at weeks 0, 4, 8, and 12 and at 2 weeks after the intake period. Results: SBP and diastolic blood pressure (DBP did not significantly differ between the groups. However, in subjects with grade I hypertension, DBP was significantly lower in the active test food group than in the placebo food group at week 12 and at 2 weeks after the intake period. An exploratory subgroup analysis revealed that plum extract improved DBP in subjects with normal to high obesity/class I obesity at week 12. Moreover, plum extract had positive effects on fatigue and bowel movements as determined by visual analog scale questionnaire evaluation. No abnormal changes or severe adverse events were observed in the physical examinations, blood measurements, or medical interviews in this trial. Conclusion: These results suggest that plum extract is safe for long-term intake and improves DBP in subjects with grade I hypertension.

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

    DEFF Research Database (Denmark)

    Kristoffersen, Dorte; Lindeberg, Tobias

    2004-01-01

    , on the one hand, to advance internationalisation of quality assurance of higher education, and on the other hand, allow for the differences in the national approaches to quality assurance. The paper will focus on two issues: first, the strength and weaknesses of the method employed and of the use of the ENQA......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 need...

  19. Metrology's role in quality assurance

    International Nuclear Information System (INIS)

    Zeederberg, L.B.

    1982-01-01

    Metrology, the science of measurement, is playing an increasing role in modern industry as part of an on-going quality assurance programme. At Escom, quality assurance was critical during the construction of the Koeberg nuclear facility, and also a function in controlling services provided by Escom. This article deals with the role metrology plays in quality assurance

  20. Quality assurance program plan for radionuclide airborne emissions monitoring

    International Nuclear Information System (INIS)

    Boom, R.J.

    1995-03-01

    This Quality Assurance Program Plan identifies quality assurance program requirements and addresses the various Westinghouse Hanford Company organizations and their particular responsibilities in regards to sample and data handling of airborne emissions. The Hanford Site radioactive airborne emissions requirements are defined in National Emissions Standards for Hazardous Air Pollutants (NESHAP), Code of Federal Regulations, Title 40, Part 61, Subpart H (EPA 1991a). Reporting of the emissions to the US Department of Energy is performed in compliance with requirements of US Department of Energy, Richland Operations Office Order 5400.1, General Environmental Protection Program (DOE-RL 1988). This Quality Assurance Program Plan is prepared in accordance with and to the requirements of QAMS-004/80, Guidelines and Specifications for Preparing Quality Assurance Program Plans (EPA 1983). Title 40 CFR Part 61, Appendix B, Method 114, Quality Assurance Methods (EPA 1991b) specifies the quality assurance requirements and that a program plan should be prepared to meet the requirements of this regulation. This Quality Assurance Program Plan identifies NESHAP responsibilities and how the Westinghouse Hanford Company Environmental, Safety, Health, and Quality Assurance Division will verify that the methods are properly implemented

  1. An operational health physics quality assurance program

    International Nuclear Information System (INIS)

    Costigan, S.A.; McAtee, J.L. III; Somers, W.M.; Huchton, R.L.

    1996-01-01

    DOE Order 5700.6C, Quality Assurance, stipulates QA requirements for all DOE activities. This order is now codified as 10CFR830.120, Nuclear Safety Management, Quality Assurance Requirements, which is applicable to DOE nuclear facilities. A Quality Assurance Management Plan (QAMP) was developed by the Health Physics Operations Group (ESH-1) at Los Alamos National Laboratory (LANL). The goal of the ESH-1 QAMP is to ensure that operational radiation protection activities meet the criteria outlined in DOE Order 5700.6C, DOE-ER-STD-6001-92 and 10CFR830.120. The ten required elements are QA Program, Personal Training and Qualifications, Quality Improvement, Documents and Records, Work Processes, Design, Procurement, Inspection and Acceptance Testing, Management Assessment and Independent Assessment. The QAMP has been useful for the development of QAMPs at nuclear facilities and has helped ensure uniformity of institutional requirements where Health Physics services are deployed to facilities. To implement a subset of QAMP requirements, a Quality Assurance Self-Evaluation Program (QASE) was established. This program provides a novel self-audit mechanism for the formal identification and correction of non-conforming items related to Operational Health Physics. Additionally, the QASE is a useful management tool for Radiological Control Technician Supervisors and staff and provides a tracking mechanism for ongoing problem areas. Data have been Collected for two calendar years on a number of concerns that fall into four general categories: radiological posting and labeling, instrumentation, monitoring requirements, and radiological documents/records

  2. Revision of Krsko NPP Quality Assurance Plan

    International Nuclear Information System (INIS)

    Biscan, R.; Fifnja, I.; Kavsek, D.

    2012-01-01

    International standards from nuclear power plant operation area are being frequently upgraded and revised in accordance with the continuous improvement philosophy. This philosophy applies also to the area of Quality Assurance, which has also undergone significant improvement since the early 1950s. Besides just nuclear industry, there are also other international quality standards that are being continuously developed and revised, bringing needs for upgrades also in the nuclear application. Since the beginning of Krsko NPP construction, the overall Quality Assurance program and its applicable procedures were in place to assure that all planned and systematic actions necessary to provide adequate confidence that an item or service will satisfy given requirements to quality, are in place. The overall requirements for quality as one of the major objectives for Krsko NPP operation are also set forth in the Updated Safety Analyses Report, the document that serves as a base for operating license. During more than 30 years of Krsko NPP operation, the quality requirements and related documents were revised and upgraded in several attempts. The latest revision 6 of QD-1, Quality Assurance Plan was issued during the year 2011. The bases for the revision were: Changes of the Slovenian regulatory requirements (ZVISJV, JV5, JV9?), Changes of Krsko NPP licensing documents (USAR section 13?), SNSA inspection requirements, Changes of international standards (IAEA, ISO?), Conclusions of first PSR, Implementation of ISO standards in Krsko NPP (ISO14001, ISO17025), Changes of plant procedures, etc. One of the most obvious changes was the enlargement of the QA Plan scope to cover interdisciplinary areas defined in the plant management program MD-1, such as Safety culture, Self-assessment, Human performance, Industrial Safety etc. The attachment of the QA Plan defining relationships between certain standards was also updated to provide matrix for better correlation of requirements of

  3. Quality assurance in microbiology

    OpenAIRE

    Arora D

    2004-01-01

    Quality assurance (QA) is the total process whereby the quality of laboratory reports can be guaranteed. The term quality control covers that part of QA, which primarily concerns the control of errors in the performance of tests and verification of test results. All materials, equipment and procedures must be adequately controlled. Culture media must be tested for sterility and performance. Each laboratory must have standard operating procedures (SOPs). QA of pre-analytical, analytical and po...

  4. SGHWR - quality assurance documentation

    International Nuclear Information System (INIS)

    Garrard, R.S.; Caulfield, J.

    1976-01-01

    The quality assurance program for a modern power station such as an SGHWR type reactor plant must include a record of quality achievement. The case history record which is evidence of the actual quality of the plant and is a data bank of design, manufacture, and results of inspections and tests, is described. Documentation distribution, which keeps all key areas informed of plant item quality status, and the retrieval and storage of information, are briefly discussed. (U.K.)

  5. High-Assurance Spiral

    Science.gov (United States)

    2017-11-01

    HIGH-ASSURANCE SPIRAL CARNEGIE MELLON UNIVERSITY NOVEMBER 2017 FINAL TECHNICAL REPORT APPROVED FOR PUBLIC RELEASE; DISTRIBUTION UNLIMITED STINFO...MU 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Carnegie Mellon University 5000 Forbes Ave Pittsburgh, PA 15217 8. PERFORMING ORGANIZATION...Approved for Public Release; Distribution Unlimited. Carnegie Mellon Carnegie Mellon HA SPIRAL Code Synthesis KeYmaera X Hybrid Theorem Prover

  6. 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.

  7. Assuring Software Reliability

    Science.gov (United States)

    2014-08-01

    technologies and processes to achieve a required level of confidence that software systems and services function in the intended manner. 1.3 Security Example...that took three high-voltage lines out of service and a software fail- ure (a race condition3) that disabled the computing service that notified the... service had failed. Instead of analyzing the details of the alarm server failure, the reviewers asked why the following software assurance claim had

  8. 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

  9. Measurement quality assurance

    International Nuclear Information System (INIS)

    Eisenhower, E.H.

    1988-01-01

    The quality of a radiation protection program can be no better than the quality of the measurements made to support it. In many cases, that quality is unknown and is merely implied on the basis of a calibration of a measuring instrument. If that calibration is inappropriate or is performed improperly, the measurement result will be inaccurate and misleading. Assurance of measurement quality can be achieved if appropriate procedures are followed, including periodic quality control actions that demonstrate adequate performance. Several national measurement quality assurance (MQA) programs are operational or under development in specific areas. They employ secondary standards laboratories that provide a high-quality link between the National Bureau of Standards and measurements made at the field use level. The procedures followed by these secondary laboratories to achieve MQA will be described, as well as plans for similar future programs. A growing general national interest in quality assurance, combined with strong specific motivations for MQA in the area of ionizing radiation, will provide continued demand for appropriate national programs. Such programs must, however, employ procedures that are cost effective and must be developed with participation by all affected parties

  10. Helical Tomotherapy Quality Assurance

    International Nuclear Information System (INIS)

    Balog, John; Soisson, Emilie

    2008-01-01

    Helical tomotherapy uses a dynamic delivery in which the gantry, treatment couch, and multileaf collimator leaves are all in motion during treatment. This results in highly conformal radiotherapy, but the complexity of the delivery is partially hidden from the end-user because of the extensive integration and automation of the tomotherapy control systems. This presents a challenge to the medical physicist who is expected to be both a system user and an expert, capable of verifying relevant aspects of treatment delivery. A related issue is that a clinical tomotherapy planning system arrives at a customer's site already commissioned by the manufacturer, not by the clinical physicist. The clinical physicist and the manufacturer's representative verify the commissioning at the customer site before acceptance. Theoretically, treatment could begin immediately after acceptance. However, the clinical physicist is responsible for the safe and proper use of the machine. In addition, the therapists and radiation oncologists need to understand the important machine characteristics before treatment can proceed. Typically, treatment begins about 2 weeks after acceptance. This report presents an overview of the tomotherapy system. Helical tomotherapy has unique dosimetry characteristics, and some of those features are emphasized. The integrated treatment planning, delivery, and patient-plan quality assurance process is described. A quality assurance protocol is proposed, with an emphasis on what a clinical medical physicist could and should check. Additionally, aspects of a tomotherapy quality assurance program that could be checked automatically and remotely because of its inherent imaging system and integrated database are discussed

  11. Specified assurance level sampling procedure

    International Nuclear Information System (INIS)

    Willner, O.

    1980-11-01

    In the nuclear industry design specifications for certain quality characteristics require that the final product be inspected by a sampling plan which can demonstrate product conformance to stated assurance levels. The Specified Assurance Level (SAL) Sampling Procedure has been developed to permit the direct selection of attribute sampling plans which can meet commonly used assurance levels. The SAL procedure contains sampling plans which yield the minimum sample size at stated assurance levels. The SAL procedure also provides sampling plans with acceptance numbers ranging from 0 to 10, thus, making available to the user a wide choice of plans all designed to comply with a stated assurance level

  12. Quality assurance for geologic investigations

    International Nuclear Information System (INIS)

    Delvin, W.L.; Gustafson, L.D.

    1983-01-01

    A quality assurance handbook was written to provide guidance in the application of quality assurance to geologic work activities associated with the National Waste Terminal Storage (NWTS) Program. It is intended to help geoscientists and NWTS program managers in applying quality assurance to their work activities and projects by showing how technical and quality assurance practices are integrated to provide control within those activities and projects. The use of the guidance found in this handbook should help provide consistency in the interpretation of quality assurance requirements across the various geologic activities wihtin the NWTS Program. This handbook also can assist quality assurance personnel in understanding the relationships between technical and quality assurance practices. This paper describes the handbook

  13. Quality assurance for geologic investigations

    International Nuclear Information System (INIS)

    Delvin, W.L.; Gustafson, L.D.

    1983-01-01

    A quality assurance handbook was written to provide guidance in the application of quality assurance to geologic work activities associated with the National Waste Terminal Storage (NWTS) Program. It is intended to help geoscientists and NWTS program managers in applying quality assurance to their work activitie and projects by showing how technical and quality assurance practices are integrated to provide control within those activities and projects. The use of the guidance found in this handbook should help provide consistency in the interpretation of quality assurance requirements across the various geologic activities within the NWTS Program. This handbook also can assist quality assurance personnel in understanding the relationships between technical and quality assurance practices. This paper describes the handbook

  14. The quality assurance liaison: Combined technical and quality assurance support

    International Nuclear Information System (INIS)

    Bolivar, S.L.; Day, J.L.

    1993-01-01

    This paper describes the role of the quality assurance liaison, the responsibilities of this position, and the evolutionary changes in duties over the last six years. The role of the quality assurance liaison has had a very positive impact on the Los Alamos Yucca Mountain Site Characterization (YW) quality assurance program. Having both technical and quality assurance expertise, the quality assurance liaisons are able to facilitate communications with scientists on quality assurance issues and requirements, thereby generating greater productivity in scientific investigations. The quality assurance liaisons help ensure that the scientific community knows and implements existing requirements, is aware of new or changing regulations, and is able to conduct scientific work within Project requirements. The influence of the role of the quality assurance liaison can be measured by an overall improvement in attitude of the staff regarding quality assurance requirements and improved job performance, as well as a decrease in deficiencies identified during both internal and external audits and surveillances. This has resulted in a more effective implementation of quality assurance requirements

  15. Chemical analysis quality assurance at the ICPP

    International Nuclear Information System (INIS)

    Hand, R.L.

    1990-01-01

    This document discusses the chemical analysis quality assurance program at the ICPP which involves records management, analytical methods quality control, analysis procedures and training and qualification. Since 1979, the major portion of the quality assurance program has been implemented on a central analytical computer system. The individual features provided by the system are storage, retrieval, and search capabilities over all general request and sample analysis information, automatic method selection for all process streams, automation of all method calculations, automatic assignment of bias and precision estimates at all analysis levels, with-method-use requalification, untrained or unqualified analyst method lockout, statistical testing of all process stream results for replicate agreement, automatic testing of process results against pre- established operating, safety, or failure limits at varying confidence levels, and automatic transfer and report of all analysis data plus all statistical testing to the Production Department

  16. Quality assurance program. Braun topical report 21

    International Nuclear Information System (INIS)

    1975-01-01

    The Quality Assurance (QA) policies and procedures described have been developed specifically for use in commercial nuclear projects. These policies and procedures are intended to provide assurance to Braun Management and the client that the plant will be safe, reliable, and operable, plus meet the requirements of the Nuclear Regulatory Commission, NRC. The Braun QA Manual provides QA procedures for (1) engineering and design, (2) procurement of materials, equipment, and services, and (3) construction and installation. The controls for safety-related systems established in the manual cover all phases of work from project inception to plant completion prior to operation by the owner. The manual standardizes Braun QA control procedures. These procedures are supplemented by Project QA Instructions prepared for each project. (U.S.)

  17. Quality assurance in the HIV/AIDS laboratory network of China.

    Science.gov (United States)

    Jiang, Yan; Qiu, Maofeng; Zhang, Guiyun; Xing, Wenge; Xiao, Yao; Pan, Pinliang; Yao, Jun; Ou, Chin-Yih; Su, Xueli

    2010-12-01

    In 2009, there were 8273 local screening laboratories, 254 confirmatory laboratories, 35 provincial confirmatory central laboratories and 1 National AIDS Reference Laboratory (NARL) in China. These laboratories were located in Center for Disease Control and Prevention (CDC) facilities, hospitals, blood donation clinics, maternal and child health (MCH) hospitals and border health quarantine health-care facilities. The NARL and provincial laboratories provide quality assurance through technical, bio-safety and managerial training; periodic proficiency testing; on-site supervisory inspections; and commercial serologic kit evaluations. From 2002 to 2009, more than 220 million HIV antibody tests were performed at screening laboratories, and all reactive and indeterminate samples were confirmed at confirmatory laboratories. The use of highly technically complex tests, including CD4 cell enumeration, viral load, dried blood spot (DBS)-based early infant diagnosis (EID), drug resistance (DR) genotyping, HIV-1 subtyping and incidence assays, have increased in recent years and their performance quality is closely monitored. China has made significant progress in establishing a well-coordinated HIV laboratory network and QA systems. However, the coverage and intensity of HIV testing and quality assurance programmes need to be strengthened so as to ensure that more infected persons are diagnosed and that they receive timely prevention and treatment services.

  18. Medical radio-physics. Quality assurance. Transparency

    International Nuclear Information System (INIS)

    Krembel, D.

    2009-07-01

    This short presentation, given by the national safety authority (ASN) at the meeting of July 1, 2009 of the high committee for the nuclear safety transparency and information (HCTISN), recalls, first, the missions of the ASN in the medical domain (radiation protection, control and inspections). Then it presents the reactions of the ASN in response to the increase of the number of radiological accidents since 2005: regulation reminder, circular letters, guidebooks, communication to the public and to the mass media. Finally, it defines the main priorities of the ASN with respect to radiotherapy: increase of human resources (radio-physicists shortage), declaration of incidents/accidents, quality assurance for the control of radiation doses delivered to patients, inspection of radiotherapy centres, expertise of new devices, improvement of softwares safety and ergonomics. (J.S.)

  19. The inverted cup device for blood transfer on malaria RDTs: ease of use, acceptability and safety in routine use by health workers in Nigeria.

    Science.gov (United States)

    Incardona, Sandra; Mwancha-Kwasa, Magoma; Rees-Channer, Roxanne R; Albertini, Audrey; Havumaki, Joshua; Chiodini, Peter; Oyibo, Wellington; Gonzalez, Iveth J

    2018-01-15

    Malaria rapid diagnostic tests (RDTs) are becoming widely adopted for case management at community level. However, reports and anecdotal observations indicate that the blood transfer step poses a significant challenge to many users. This study sought to evaluate the inverted cup device in the hands of health workers in everyday clinical practice, in comparison with the plastic pipette, and to determine the volume accuracy of the device made of a lower-cost plastic. The volume accuracy of inverted cup devices made of two plastics, PMMA and SBC, was compared by transferring blood 150 times onto filter paper and comparing the blood spot areas with those produced by 20 reference transfers with a calibrated micropipette. The ease of use, safety and acceptability of the inverted cup device and the pipette were evaluated by 50 health workers in Nigeria. Observations were recorded on pre-designed questionnaires, by the health workers themselves and by trained observers. Focus group discussions were also conducted. The volume accuracy assessment showed that the device made from the low-cost material (SBC) delivered a more accurate volume (mean 5.4 μL, SD 0.48 μL, range 4.5-7.0 μL) than the PMMA device (mean 5.9 μL, SD 0.48 μL, range 4.9-7.2 μL). The observational evaluation demonstrated that the inverted cup device performed better than the pipette in all aspects, e.g. higher proportions of health workers achieved successful blood collection (96%, vs. 66%), transfer of the required blood volume (90%, vs. 58%), and blood deposit without any loss (95%, vs. 50%). Majority of health workers also considered it' very easy' to use (81%),'very appropriate' for everyday use (78%), and 50% of them reported that it was their preferred BTD. The good volume accuracy and high acceptability of the inverted cup device shown in this study, along with observed ease of use and safety in hands of health workers, further strengthens prior findings which demonstrated its higher

  20. First-time whole blood donation: A critical step for donor safety and retention on first three donations.

    Science.gov (United States)

    Gillet, P; Rapaille, A; Benoît, A; Ceinos, M; Bertrand, O; de Bouyalsky, I; Govaerts, B; Lambermont, M

    2015-01-01

    Whole blood donation is generally safe although vasovagal reactions can occur (approximately 1%). Risk factors are well known and prevention measures are shown as efficient. This study evaluates the impact of the donor's retention in relation to the occurrence of vasovagal reaction for the first three blood donations. Our study of data collected over three years evaluated the impact of classical risk factors and provided a model including the best combination of covariates predicting VVR. The impact of a reaction at first donation on return rate and complication until the third donation was evaluated. Our data (523,471 donations) confirmed the classical risk factors (gender, age, donor status and relative blood volume). After stepwise variable selection, donor status, relative blood volume and their interaction were the only remaining covariates in the model. Of 33,279 first-time donors monitored over a period of at least 15 months, the first three donations were followed. Data emphasised the impact of complication at first donation. The return rate for a second donation was reduced and the risk of vasovagal reaction was increased at least until the third donation. First-time donation is a crucial step in the donors' career. Donors who experienced a reaction at their first donation have a lower return rate for a second donation and a higher risk of vasovagal reaction at least until the third donation. Prevention measures have to be processed to improve donor retention and provide blood banks with adequate blood supply. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  1. Software quality assurance | News

    Science.gov (United States)

    Financial Officer Finance Section Office of the Chief Operating Officer Facilities Engineering Services Accelerator Division Accelerator Physics Center Office of the Chief Safety Officer Environment, Safety, Health and Quality Section Office of the Chief Project Officer Office of Project Support Services Office of

  2. Hyperthermia quality assurance

    International Nuclear Information System (INIS)

    Shrivastava, P.N.; Paliwal, B.R.

    1984-01-01

    Hyperthermia Physics Center (HPC) operating under contract with the National Cancer Institute is developing a Quality Assurance program for local and regional hyperthermia. The major clinical problem in hyperthermia treatments is that they are extremely difficult to plan, execute, monitor and reproduce. A scientific basis for treatment planning can be established only after ensuring that the performance of heat generating and temperature monitoring systems are reliable. The HPC is presently concentrating on providing uniform NBS traceable calibration of thermometers and evaluation of reproducibility for power generator operation, applicator performance, phanta compositions, system calibrations and personnel shielding. The organizational plan together with recommended evaluation measurements, procedures and criteria are presented

  3. How much quality assurance?

    International Nuclear Information System (INIS)

    Beatty, R.A.; Talboy, J.H.

    1988-01-01

    This paper describes the approach used at Argonne National Laboratory to apply the techniques of quality assurance to research and development activities. The discussion includes the approach, the reasons that it is gaining acceptance, and its wide applicability. This approach is founded on the lessons learned in management of quality at Argonne National Laboratory over a period of more than 15 years. The discussion is confined to the practices at the Illinois site of the Laboratory where more than 3000 researchers and support personnel conduct basic and technology-directed research

  4. Quality assurance services

    International Nuclear Information System (INIS)

    For over 20 years the quality assurance services at the Springfields Laboratories have been concerned with manufacturing both simple and complex engineering products to the highest standard. The scientists working there have considerable expertise in the practical application of quality control and the development and design of inspection and non-destructive testing equipment. The folder contains six sheets or leaflets illustrating the work and equipment. The subjects are the mechanical standards laboratory, non-destructive testing, the digitising table, the peripheral camera, automated measurement, data handling and presentation, and the computer controlled three axis co-ordinate measuring machine. (U.K.)

  5. BWR internals life assurance

    International Nuclear Information System (INIS)

    Herrera, M.L.; Stancavage, P.P.

    1988-01-01

    Boiling water reactor (BWR) internal components play an important role in power plant life extension. Many important internals were not designed for easy removal and changes in material properties and local environmental effects due to high radiation makes stress corrosion cracking more likely and more difficult to correct. Over the past several years, operating experience has shown that inspection, monitoring and refurbishment can be accomplished for internal structures with existing technology. In addition, mitigation techniques which address the causes of degradation are available to assure that life extension targets can be met. This paper describes the many considerations and aspects when evaluating life extension for reactor vessel internals

  6. Software Quality Assurance Audits Guidebooks

    Science.gov (United States)

    1990-01-01

    The growth in cost and importance of software to NASA has caused NASA to address the improvement of software development across the agency. One of the products of this program is a series of guidebooks that define a NASA concept of the assurance processes that are used in software development. The Software Assurance Guidebook, NASA-GB-A201, issued in September, 1989, provides an overall picture of the NASA concepts and practices in software assurance. Second level guidebooks focus on specific activities that fall within the software assurance discipline, and provide more detailed information for the manager and/or practitioner. This is the second level Software Quality Assurance Audits Guidebook that describes software quality assurance audits in a way that is compatible with practices at NASA Centers.

  7. Quality assurance and reliability

    International Nuclear Information System (INIS)

    Normand, J.; Charon, M.

    1975-01-01

    Concern for obtaining high-quality products which will function properly when required to do so is nothing new - it is one manifestation of a conscientious attitude to work. However, the complexity and cost of equipment and the consequences of even temporary immobilization are such that it has become necessary to make special arrangements for obtaining high-quality products and examining what one has obtained. Each unit within an enterprise must examine its own work or arrange for it to be examined; a unit whose specific task is quality assurance is responsible for overall checking, but does not relieve other units of their responsibility. Quality assurance is a form of mutual assistance within an enterprise, designed to remove the causes of faults as far as possible. It begins very early in a project and continues through the ordering stage, construction, start-up trials and operation. Quality and hence reliability are the direct result of what is done at all stages of a project. They depend on constant attention to detail, for even a minor piece of poor workmanship can, in the case of an essential item of equipment, give rise to serious operational difficulties

  8. Operational safety

    International Nuclear Information System (INIS)

    Anon.

    1977-01-01

    The PNL Safety, Standards and Compliance Program contributed to the development and issuance of safety policies, standards, and criteria; for projects in the nuclear and nonnuclear areas. During 1976 the major emphasis was on developing criteria, instruments and methods to assure that radiation exposure to occupational personnel and to people in the environs of nuclear-related facilities is maintained at the lowest level technically and economically practicable. Progress in 1976 is reported on the preparation of guidelines for radiation exposure; Pu dosimetry studies; the preparation of an environmental monitoring handbook; and emergency instrumentation preparedness

  9. Quality assurance requirements for packaging and transportation of radioactive materials

    International Nuclear Information System (INIS)

    Barker, R.F.; MacDonald, C.E.; Doda, R.J.

    1978-01-01

    This paper discusses the new quality assurance regulations of the Nuclear Regulatory Commission (NRC) for packaging and transportation of radioactive materials. These regulations became effective on October 18, 1977. Background information concerning these regulations and packaging and transportation history is included. The quality assurance program is described with indications of how it is composed of general (administrative) provisions which must meet the 18 quality assurance criteria and be approved by the NRC; specific provisions which appear in the DOT and NRC regulations and in the individual package design approval; and other specific procedures which are not required by regulations but which are necessary for the proper control of quality. The quality assurance program is to be developed using a graded approach for the application of pertinent criteria and optimizing the required degree of safety and control efforts involved in achieving this level of safety. The licensee-user is responsible for all phases of quality assurance for packaging activities including: design, manufacture, test, use, maintenance and repair. The package design phase is considered to be particularly important in producing adequate safety in operational activities concerning packaging and transportation of radioactive materials

  10. 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.

  11. Quality assurance in production and use of special form radioactive material - focal points in BAM approvals

    International Nuclear Information System (INIS)

    Rolle, A.; Buhlemann, L.

    2004-01-01

    BAM as the competent authority for approval of special form radioactive material attaches great importance to a detailed audit of the required quality assurance programs for design, manufacture, testing, documentation, use, maintenance and inspection. Applicants have to submit, together with application documentation information on general arrangements for quality assurance, as well as on quality assurance in production and in operation. Fields where BAM has often found deficiencies are leak test methods, weld seam quality and the safety level after use

  12. Quality assurance of fuel elements

    International Nuclear Information System (INIS)

    Hoerber, J.

    1980-01-01

    The quality assurance activities for reactor fuel elements are based on a quality assurance system which implies the requirements resulting from the specifications, regulations of the authorities, national standards and international rules and regulations. The quality assurance related to production of reactor fuel will be shown for PWR fuel elements in all typical fabrication steps as conversion into UO 2 -powder, pelletizing, rodmanufacture and assembling. A wide range of destructive and nondestructive techniques is applied. Quality assurance is not only verified by testing techniques but also by process monitoring by means of parameter control in production and testing procedures. (RW)

  13. The assurance management program for the Nova laser fusion project

    International Nuclear Information System (INIS)

    Levy, A.J.

    1983-01-01

    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 Inertial Confinement Fusion (ICF) approach is explained in general terms. The laser ICF and magnetic fusion facilities are significantly different in that the laser system is used solely as a highly reliable energy source for performing plasma physics experiments related to fusion target development; by contrast, magnetic fusion facilities are themselves the experiments. The Nova project consists of a 10-beam, 74 cm aperture neodymium-glass laser experimental facility which is being constructed by the Lawrence Livermore National Laboratory (LLNL) for the U.S. Department of Energy. Nova has a total estimated cost of $176M and will become operational in the Fall of 1984. The Nova laser will be used as the high energy driver for studying the regime of ignition for ICF. 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

  14. Regulatory inspection of the implementation of quality assurance programmes

    International Nuclear Information System (INIS)

    1989-01-01

    This Manual provides guidance to Member States in the organization and performance of their regulatory inspection functions regarding the implementation of nuclear power plant quality assurance programmes. It addresses the interface between, and is consistent with, the IAEA Nuclear Safety Standards (NUSS programme) documents on quality assurance and governmental organization. The Manual offers a practical model and examples for performing regulatory inspections to ensure that the quality assurance programme is operating satisfactorily in the siting, design, manufacturing, construction, commissioning, operation and decommissioning of nuclear power plants. The primary objective is to confirm that the licensee has the capability to manage and control the effective performance of all quality assurance responsibilities during all phases of a nuclear power project. The guidance provided through this Manual for proper establishment and execution of the regulatory inspections helps to enforce the effective implementation of the quality assurance programme as a management control system that the nuclear industry should establish and use in attaining the safety and reliability objectives for nuclear installations. This enforcement action by national regulatory bodies and the emphasis on the purposes and advantages of quality assurance as an important management tool integrated within the total project task have been recommended by the IAEA International Nuclear Safety Advisory Group (INSAG). The primary intended users of this Manual are the management personnel and high level staff from regulatory bodies but it will also be helpful to management personnel from nuclear utilities and vendors. They all are inevitable partners in a nuclear power project and this document offers all of them valuable information on the better accomplishment of quality assurance activities to ensure the common objective of safe and reliable nuclear power production

  15. General rules applicable to quality assurance

    International Nuclear Information System (INIS)

    1981-11-01

    RFS or Regles Fondamentales de Surete (Basic Safety Rules) applicable to certain types of nuclear facilities lay down requirements with which compliance, for the type of facilities and within the scope of application covered by the RFS, is considered to be equivalent to compliance with technical French regulatory practice. The object of the RFS is to take advantage of standardization in the field of safety, while allowing for technical progress in that field. They are designed to enable the operating utility and contractors to know the rules pertaining to various subjects which are considered to be acceptable by the Service Central de Surete des Installations Nucleaires, or the SCSIN (Central Department for the Safety of Nuclear Facilities). These RFS should make safety analysis easier and lead to better understanding between experts and individuals concerned with the problems of nuclear safety. The SCSIN reserves the right to modify, when considered necessary, any RFS and specify, if need be, the terms under which a modification is deemed retroactive. The aim of this rule is to define a series of measures to meet these general regulatory equipments. By applying this rule, the quality assurance code of practice for nuclear power plant safety, established by the International Atomic Energy Agency (I.A.E.A.), is considered to be observed

  16. Reactor safety

    International Nuclear Information System (INIS)

    Meneley, D.A.

    The people of Ontario have begun to receive the benefits of a low cost, assured supply of electrical energy from CANDU nuclear stations. This indigenous energy source also has excellent safety characteristics. Safety has been one of the central themes of the CANDU development program from its very beginning. A great deal of work has been done to establish that public risks are small. However, safety design criteria are now undergoing extensive review, with a real prospect of more stringent requirements being applied in the future. Considering the newness of the technology it is not surprising that a consensus does not yet exist; this makes it imperative to discuss the issues. It is time to examine the policies and practice of reactor safety management in Canada to decide whether or not further restrictions are justified in the light of current knowledge

  17. 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

  18. Are your employees protected from blood-borne pathogens? OSHA standards charge textile rental companies with responsibility for worker safety.

    Science.gov (United States)

    Weller, S C

    1991-11-01

    Congress is putting pressure on OSHA to finalize its Universal Precaution standards by December. When the standards go into effect, textile rental companies that serve medical, dental, and outpatient care facilities--including private physician and dentist offices--must take steps to protect employees from blood-borne pathogens. Soiled linens, towels, gowns, and other items from any customer in risk categories link a textile rental facility and/or commercial laundry with the OSHA regulations. Read and heed this information.

  19. Impact of antigenic exposures and role of molecular blood grouping in enhancing transfusion safety in chronically transfused thalassemics.

    Science.gov (United States)

    Makroo, Raj Nath; Agrawal, Soma; Bhatia, Aakanksha; Chowdhry, Mohit; Thakur, Uday Kumar

    2016-01-01

    Red cell alloimmunization is an acknowledged complication of blood transfusion. Current transfusion practices for thalassemia do not cater to this risk. Serological phenotyping is usually not reliable in these cases unless performed before the first transfusion. Under such circumstances, molecular blood grouping is an effective alternative. To perform molecular blood group genotyping in chronically transfused thalassemia patients and assess the risk of antigenic exposure and incidence of alloimmunization with current transfusion protocols. Molecular blood group genotyping was performed for 47 chronically transfused thalassemia patients. Their 1-year transfusion records were retrieved to assess the antigenic exposure and the frequency thereof. Of 47 patients, 6 were already alloimmunized (3 with anti-E and 3 with anti-K) and were receiving the corresponding antigen negative units. We observed that random selection of ABO and Rh D matched units resulted in 57.7% ±8.26% chance of Rh and Kell phenotype matching also. Forty-four patients had received one or more antigenic exposures at least once. The 6 already alloimmunized patients were further exposed to antigens other than the ones they were immunized to. During the study period, only one patient developed an alloantibody, anti-E with exposure to antigens C (92%) and/or E (32%) at each transfusion. Several factors apart from mere antigen exposure may influence the development of alloimmunization as most of our patients received antigenic exposures but not alloimmunized. Our data provide an impetus for future large-scale studies to understand the development of alloimmunization in such patients.

  20. Impact of antigenic exposures and role of molecular blood grouping in enhancing transfusion safety in chronically transfused thalassemics

    Directory of Open Access Journals (Sweden)

    Raj Nath Makroo

    2016-01-01

    Full Text Available Background: Red cell alloimmunization is an acknowledged complication of blood transfusion. Current transfusion practices for thalassemia do not cater to this risk. Serological phenotyping is usually not reliable in these cases unless performed before the first transfusion. Under such circumstances, molecular blood grouping is an effective alternative. Aim: To perform molecular blood group genotyping in chronically transfused thalassemia patients and assess the risk of antigenic exposure and incidence of alloimmunization with current transfusion protocols. Materials and Methods: Molecular blood group genotyping was performed for 47 chronically transfused thalassemia patients. Their 1-year transfusion records were retrieved to assess the antigenic exposure and the frequency thereof. Results: Of 47 patients, 6 were already alloimmunized (3 with anti-E and 3 with anti-K and were receiving the corresponding antigen negative units. We observed that random selection of ABO and Rh D matched units resulted in 57.7% ±8.26% chance of Rh and Kell phenotype matching also. Forty-four patients had received one or more antigenic exposures at least once. The 6 already alloimmunized patients were further exposed to antigens other than the ones they were immunized to. During the study period, only one patient developed an alloantibody, anti-E with exposure to antigens C (92% and/or E (32% at each transfusion. Conclusion: Several factors apart from mere antigen exposure may influence the development of alloimmunization as most of our patients received antigenic exposures but not alloimmunized. Our data provide an impetus for future large-scale studies to understand the development of alloimmunization in such patients.

  1. West Valley Reprocessing Plant. Safety analysis report, supplement 21

    International Nuclear Information System (INIS)

    1976-01-01

    Supplement No. 21 contains responses to USNRC questions on quality assurance contained in USNRC letter to NFS dated January 22, 1976, revised pages for the safety analysis report, and Appendix IX ''Quality Assurance Manual--West Valley Construction Projects.''

  2. Operating and Assurance Program Plan. Revision 4

    Energy Technology Data Exchange (ETDEWEB)

    1994-07-01

    The LBL Operating and Assurance Program (OAP) is a management system and a set of requirements designed to maintain the level of performance necessary to achieve LBL`s programmatic and administrative objectives effectively and safely through the application of quality assurance and related conduct of operations and maintenance management principles. Implement an LBL management philosophy that supports and encourages continual improvement in performance and quality at the Laboratory. Provide an integrated approach to compliance with applicable regulatory requirements and DOE orders. The OAP is intended to meet the requirements of DOE Order 5700.6C, Quality Assurance. The Program also contains management system elements of DOE Orders 5480.19, Conduct of Operations Requirements for DOE Facilities; 5480.25, Safety of Accelerator Facilities; and 4330.4A, Maintenance Management Program, and is meant to integrate these elements into the overall LBL approach to Laboratory management. The requirements of this program apply to LBL employees and organizations, and to contractors and facility users as managed by their LBL sponsors. They are also applicable to external vendors and suppliers as specified in procurement documents and contracts.

  3. Quality assurance of radiation therapy machines

    International Nuclear Information System (INIS)

    Francois, P.

    2002-01-01

    Due to the modifications of components, to unexpected breakage of elements or to electronic dysfunctions, the performance of radiotherapy machines may decrease with age. Quality Assurance procedures and maintenance program are necessary to guarantee the performances. For linear accelerators, modus operandi of control tests and their frequency are based on regulations and recommendations widely published, that are presented here. Concerning accessories, especially those recently developed (multi-leaf collimators, dynamic wedges,...), recommendations remains to be defined. Simple tests are proposed. Concerning numerical imaging systems, widely used for three dimensional dosimetry, image quality and geometry controls must be performed with fantom tests. For portal imaging, a quality assurance program is proposed. A strict and complete Quality Assurance program is essential to guarantee quality and safety of the treatment. A regular control of linear accelerator is one of the important component of this program. It suppose the implementation of permanent tests procedures, periodically modified following technological progresses and treatment techniques. Measurements must be sensible to variations below the tolerance level defined during the installation process. The analysis of the variations of measurements with time are an objective criterion of quality. (author)

  4. 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.

  5. Subsurface quality assurance practices

    International Nuclear Information System (INIS)

    1987-08-01

    This report addresses only the concept of applying Nuclear Quality Assurance (NQA) practices to repository shaft and subsurface design and construction; how NQA will be applied; and the level of detail required in the documentation for construction of a shaft and subsurface repository in contrast to the level of detail required in the documentation for construction of a traditional mine. This study determined that NQA practices are viable, attainable, as well as required. The study identified the appropriate NQA criteria and the repository's major structures, systems, items, and activities to which the criteria are applicable. A QA plan, for design and construction, and a list of documentation, for construction, are presented. 7 refs., 1 fig., 18 tabs

  6. 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..

  7. Construction quality assurance report

    International Nuclear Information System (INIS)

    Roscha, V.

    1994-01-01

    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

  8. Lonizing radiation regulations and the dental practitioner: 3. Quality assurance in dental radiography.

    Science.gov (United States)

    Rout, John; Brown, Jackie

    2012-06-01

    This is the last in a series of three articles on X-ray dose reduction and covers aspects of quality assurance. The first outlined radiation physics and protection and the second the legislation relating to radiation safety. Quality assurance is an essential part of dental radiography and is required to produce images of a consistently high standard, necessary for accurate diagnosis.

  9. The efficiency and safety of fibrin sealant for reducing blood loss in primary total hip arthroplasty: A systematic review and meta-analysis.

    Science.gov (United States)

    Wang, Zhiyuan; Xiao, Lin; Guo, Hao; Zhao, Guanghui; Ma, Jianbing

    2017-01-01

    Total hip arthroplasty (THA) is associated with substantial blood loss. The objective of present systematic review and meta-analysis is to provide evidence from randomized controlled trials (RCTs) on the efficiency and safety of administration of fibrin sealant (FS) for reducing blood loss in patients undergoing primary THA. Potential relevant studies were identified from electronic databases including Medline, PubMed, Embase, ScienceDirect, web of science and Cochrane Library. Gray academic studies were also identified from the reference list of included studies. There was no language restriction. Pooling of data was carried out by using RevMan 5.1. Six randomized controlled trials (RCTs) met the inclusion criteria. Current meta-analysis indicated that there were significant differences in terms of total blood loss (MD = -153.77, 95% CI: -287.21 to -20.34, P = 0.02), postoperative hemoglobin level (MD = -0.25, 95% CI: -0.46 to -0.05, P = 0.02) and transfusion rate (RD = -0.12, 95% CI: -0.22 to -0.03, P = 0.01) between groups. No significant differences were found regarding the incidence of deep venous thrombosis (DVT) (RD = 0.00, 95% CI: -0.01to 0.01, P = 0.51) or other side effects. Administration of fibrin sealant in total hip arthroplasty may reduce total blood loss, postoperative hemoglobin decline and transfusion requirements. Moreover, no adverse effect was related to FS. Due to the limited quality of the evidence currently available, higher quality RCTs are required. Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  10. 24 CFR 232.630 - Assurance of completion.

    Science.gov (United States)

    2010-04-01

    ... URBAN DEVELOPMENT MORTGAGE AND LOAN INSURANCE PROGRAMS UNDER NATIONAL HOUSING ACT AND OTHER AUTHORITIES MORTGAGE INSURANCE FOR NURSING HOMES, INTERMEDIATE CARE FACILITIES, BOARD AND CARE HOMES, AND ASSISTED... Fire Safety Equipment Special Requirements § 232.630 Assurance of completion. If the property upon...

  11. Quality assurance during site construction of nuclear power plants

    International Nuclear Information System (INIS)

    1981-01-01

    This Safety Guide provides requirements and recommendations related to the establishment and implementation of a quality assurance programme for the site construction activities at nuclear power plants. These include activities such as fabricating, erecting, installing, handling, storing, cleaning, flushing, inspecting, testing, modifying, repairing, and maintaining

  12. 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…

  13. Quality assurance of operating instructions

    International Nuclear Information System (INIS)

    Asmuss, G.

    1992-01-01

    It is pointed out that the quality assurance at nuclear power stations must be supported by national and international regulations. Quality assurance is explained using the example of the design of a pressurised water reactor. The operating and emergency manuals are discussed and examples for their structure put forward. The significance of updating is emphasised. 15 figs., 19 refs

  14. Project Specific Quality Assurance Plan

    International Nuclear Information System (INIS)

    Pedersen, K.S.

    1995-01-01

    This Quality Assurance Project Plan (QAPP) identifies the Westinghouse Hanford Co. (WHC) Quality Assurance (QA) program requirements for all contractors involved in the planning and execution of the design, construction, testing and inspection of the 200 Area Effluent BAT/AKART Implementation, Project W-291

  15. Printed Circuit Board Quality Assurance

    Science.gov (United States)

    Sood, Bhanu

    2016-01-01

    PCB Assurance Summary: PCB assurance actives are informed by risk in context of the Project. Lessons are being applied across Projects for continuous improvements. Newer component technologies, smaller/high pitch devices: tighter and more demanding PCB designs: Identifying new research areas. New materials, designs, structures and test methods.

  16. R D software quality assurance

    Energy Technology Data Exchange (ETDEWEB)

    Hood, F.C.

    1991-10-01

    Research software quality assurance (QA) requirements must be adequate to strengthen development or modification objectives, but flexible enough not to restrict creativity. Application guidelines are needed for the different kinds of research and development (R D) software activities to assure project objectives are achieved.

  17. Functional safety measurement in the automotive domain : adaptation of PSM

    NARCIS (Netherlands)

    Luo, Y.; Stelma, J.; Brand, van den M.G.J.

    2015-01-01

    In the safety domain, safety standards are used as a development guideline to keep the risk at an acceptable level. Safety of the safety-critical systems can be assessed according to those safety standards. This assessment process is called safety assurance. Due to the manual work, the safety

  18. Quality assurance auditing for nuclear power plants

    International Nuclear Information System (INIS)

    1980-01-01

    This Safety Guide provides requirements and recommendations for establishing and implementing a system of internal and external audits during the design, manufacture, construction, commissioning and operation of nuclear power plants. It provides for the planning, performance, reporting and follow-up of the quality assurance audit activity. It defines in general terms the responsibilities of the auditing and audited organizations. The Guide also covers auditing in the context of supplier evaluation; it does not include inspection for the sole purpose of process control or product acceptance. Like the Code, the present Guide was prepared as part of the IAEA's programme, referred to as the NUSS programme, for establishing Codes of Practice and Safety Guides relating to land-based stationary thermal neutron power plants

  19. Legacy Management CERCLA Sites. Quality Assurance Project Plan

    International Nuclear Information System (INIS)

    2007-01-01

    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 implementing the QA

  20. Methods of Software Quality Assurance under a Nuclear Quality Assurance Program

    International Nuclear Information System (INIS)

    Kim, Jang Yeol; Lee, Young Jun; Cha, Kyung Ho; Cheon, Se Woo; Lee, Jang Soo; Kwon, Kee Choon

    2005-01-01

    This paper addresses a substantial implementation of a software quality assurance under a nuclear quality assurance program. The relationship of the responsibility between a top-level nuclear quality assurance program such as ASME/NQA-1 and its lower level software quality assurance is described. Software quality assurance activities and software quality assurance procedures during the software development life cycle are also described

  1. DOE's Assurance Program for Remedial Action (APRA)

    International Nuclear Information System (INIS)

    Denham, D.H.; Stenner, R.D.; Welty, C.G. Jr.; Needels, T.S.

    1985-01-01

    The US Department of Energy's (DOE) Office of Operational Safety (OOS) is presently developing and implementing the Assurance Program for Remedial Action (APRA) to overview DOE's Remedial Action programs. APRA's objective is to ensure the adequacy of environmental, safety and health (ES and H) protection practices within the four DOE Remedial Action programs: Grand Junction Remedial Action Program (GJRAP), Uranium Mill Tailings Remedial Action Program (UMTRAP), Formerly Utilized Sites Remedial Action Program (FUSRAP), and Surplus Facilities Management Program (SFMP). APRA encompasses all ES and H practices of DOE and its contractors/subcontractors within the four Remedial Action programs. Specific activities of APRA include document reviews, selected site visits, and program office appraisals. Technical support and assistance to OOS is being provided by APRA contractors in the evaluation of radiological standards and criteria, quality assurance measures, radiation measurements, and risk assessment practices. This paper provides an overview of these activities and discusses program to date, including the roles of OOS and the respective contractors. The contractors involved in providing technical support and assistance to OOS are Aerospace Corporation, Oak Ridge Associated Universities, and Pacific Northwest Laboratory

  2. DOE's Assurance Program for Remedial Action (APRA)

    International Nuclear Information System (INIS)

    Denham, D.H.; Stenner, R.D.; Welty, C.G. Jr.; Needels, T.S.

    1984-10-01

    The US Department of Energy's (DOE) Office of Operational Safety (OOS) is presently developing and implementing the Assurance Program for Remedial Action (APRA) to overview DOE's Remedial Action programs. APRA's objective is to ensure the adequacy of environmental, safety and health (ES and H) protection practices within the four DOE Remedial Action programs: Grand Junction Remedial Action Program (GJRAP), Uranium Mill Tailings Remedial Action Program (UMTRAP), Formerly Utilized Sites Remedial Action Program (FUSRAP), and Surplus Facilities Management Program (SFMP). APRA encompasses all ES and H practices of DOE and its contractors/subcontractors within the four Remedial Action programs. Specific activities of APRA include document reviews, selected site visits, and program office appraisals. Technical support and assistance to OOS is being provided by APRA contractors in the evaluation of radiological standards and criteria, quality assurance measures, radiation measurements, and risk assessment practices. This paper provides an overview of these activities and discusses progress to date, including the roles of OOS and the respective contractors. The contractors involved in providing technical support and assistance to OOS are Aerospace Corporation, Oak Ridge Associated Universities, and Pacific Northwest Laboratory

  3. Nevada Nuclear Waste Storage Investigations: Quality Assurance Plan

    International Nuclear Information System (INIS)

    1980-08-01

    The Nevada Nuclear Waste Storage Investigations (NNWSI) were established by DOE/NV to evaluate the geohydrologic setting and underground rock masses of the Nevada Test Site (NTS) and contiguous areas to determine whether a suitable site exists for constructing a repository for isolating highly radioactive solid wastes. Since the results of these evaluations will impact possible risks to public health and safety, a quality assurance program which conforms to the criteria given in the Code of Federal Regulations is needed to control the quality aspects of the work. This Quality Assurance Plan (QAP) describes the general quality assurance program for the overall NNWSI project under which the quality assurance programs of the individual participating organizations and support contractors are to operate. The details of how each of these groups will meet the criteria will differ among participating organizations and support contractors, and those details are given in the QAPP's listed in Appendix A. It is the purpose of this plan to show the commonality of quality assurance programs in effect within the project and to define how each element fits into the entire picture to give total quality assurance coverage for the NNWSI Project

  4. Operating the plant, quality assurance, and the job of the operating staff, Volume Twelve

    International Nuclear Information System (INIS)

    Anon.

    1986-01-01

    Subject matter includes operating the plant (the role of the operator, the control room, plant technical specifications, plant operating procedures, initial startup program, BWR/PWR plant startup, BWR/PWR steady state power operation, BWR/PWR transient operation, emergency operation), quality assurance (what is quality, what is quality control, quality assurance includes quality control, government regulation and quality assurance, administrative controls for nuclear power plants, the necessity of reviews and audits, practical quality assurance), and the job of the operating staff (the plant operating staff, plant safety, first aid and resuscitation, general plant hazards, personnel protective equipment, handling chemicals, handling compressed gas, equipment repair and maintenance, communicating with others

  5. Qualification of quality assurance program audit personnel for nuclear power plants - August 1980

    International Nuclear Information System (INIS)

    Anon.

    1981-01-01

    Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities, establishes overall quality assurance requirements for the design, construction, and operation of safety-related structures, and components of nuclear power plants. Criterion XVIII, Audits, of Appendix B establishes requirements for conducting audits of the quality assurance program. This guide describes a method acceptable to the NRC staff for complying with the Commission's regulations with regard to qualification of quality assurance program audit personnel for nuclear power plants

  6. Quality assurance in tissue banking

    International Nuclear Information System (INIS)

    Von Versen, R.; Mnig, H. J.; Bettin, D.

    1999-01-01

    Today the different kinds of human allografts have the full acceptance for the clinical application for the treatment of a very wide range of indications in many medical disciplines. An essential aspect of this acceptance of these allografts is the complete biological safety, first of all the exclusion of virus contaminations. The German Institute for Cell and Tissue Replacement (DIZG) is functioning as a national tissue bank cooperating with more than 300 hospitals in Germany and Austria. Its profile is determined by the processing of tissue allografts like cortical and cancellous bone, fascia lata, tendon as well as skin, skin substitutes and cultured autologous and allogenic kerytinocytes. DIZG is licensed by the German Federal Institute for Pharmaceuticals and Medical Products and the country health authorities. To ensure that the allografts fulfill the highest quality requirements a controlled and certified quality management system has been established. In accordance with the Good Manufacturing Practice all procedures are perform-ned on the basis of validated methods. All non-vital allografts are sterilized by a chemical sterilisation method with peracetic acid (PAA) that is validated by the Robert Koch Institute, an independent governmental institution, for the inactivation of bacteria, fungi and viruses. The used test viruses are Pseudorabies V, Polio V, Bovine Virusdiarrhoe V, Parvo V, Hepatitis A V, HIV). The DIZG quality management system (QMS) is based on ISO 9001 which is required for institutions that are involved in processing, research and education and is certified by an international auditing body. With this presentation the validation design shall be introduced and the responsibility of regional and national tissue banks for internal and external quality control and quality assurance shall be discussed

  7. Compliance assurance in the field of radioactive material transport in Russia

    International Nuclear Information System (INIS)

    Ershov, V.; Syssoev, M.

    1999-01-01

    The main provisions of the system of compliance assurance, as understood in the IAEA Safety Regulations, are presented in this article as they are applied in Russia in the field of transport of radioactive materials. The urgency of the development and enactment of the uniform programme of compliance assurance in this area is underlined since it is foreseen by the new national regulations for the safety of radioactive material transport in Russia. (author)

  8. Quality assurance in the procurement, design and manufacture of nuclear fuel assemblies

    International Nuclear Information System (INIS)

    1983-01-01

    This Safety Guide provides requirements and recommendations for quality assurance programmes that are relevant for the unique features of the procurement, design, manufacture, inspection, testing, packaging, shipping, storage, and receiving inspection of fuel assemblies for nuclear power plants. The generic quality assurance requirements of the Code and related Safety Guides are referred to where applicable, and are duplicated in this document where increased emphasis is desirable

  9. 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

    2016-02-01

    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. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  10. An integrative pharmacological approach to radio telemetry and blood sampling in pharmaceutical drug discovery and safety assessment.

    Science.gov (United States)

    Litwin, Dennis C; Lengel, David J; Kamendi, Harriet W; Bialecki, Russell A

    2011-01-18

    A successful integration of the automated blood sampling (ABS) and telemetry (ABST) system is described. The new ABST system facilitates concomitant collection of physiological variables with blood and urine samples for determination of drug concentrations and other biochemical measures in the same rat without handling artifact. Integration was achieved by designing a 13 inch circular receiving antenna that operates as a plug-in replacement for the existing pair of DSI's orthogonal antennas which is compatible with the rotating cage and open floor design of the BASi Culex® ABS system. The circular receiving antenna's electrical configuration consists of a pair of electrically orthogonal half-toroids that reinforce reception of a dipole transmitter operating within the coil's interior while reducing both external noise pickup and interference from other adjacent dipole transmitters. For validation, measured baclofen concentration (ABST vs. satellite (μM): 69.6 ± 23.8 vs. 76.6 ± 19.5, p = NS) and mean arterial pressure (ABST vs. traditional DSI telemetry (mm Hg): 150 ± 5 vs.147 ± 4, p = NS) variables were quantitatively and qualitatively similar between rats housed in the ABST system and traditional home cage approaches. The ABST system offers unique advantages over traditional between-group study paradigms that include improved data quality and significantly reduced animal use. The superior within-group model facilitates assessment of multiple physiological and biochemical responses to test compounds in the same animal. The ABST also provides opportunities to evaluate temporal relations between parameters and to investigate anomalous outlier events because drug concentrations, physiological and biochemical measures for each animal are available for comparisons.

  11. In vitro safety assessment of the strawberry tree (Arbutus unedo L.) water leaf extract and arbutin in human peripheral blood lymphocytes.

    Science.gov (United States)

    Jurica, K; Brčić Karačonji, I; Mikolić, A; Milojković-Opsenica, D; Benković, V; Kopjar, N

    2018-04-25

    Strawberry tree (Arbutus unedo L.) leaves have long been used in the traditional medicine of the Mediterranean region. One of their most bioactive constituents is the glycoside arbutin, whose presence makes A. unedo suitable as a potential substitute for bearberry [Arctostaphylos uva ursi (L.) Spreng] leaves, an herbal preparation widely used for treating urinary tract infections. The safety and biocompatibility of strawberry tree water leaf extract have not yet been documented well. This study estimated arbutin content in strawberry tree water leaf extract (STE) using high performance liquid chromatography. Furthermore, we performed an in vitro safety assessment of the 24 h exposure to three presumably non-toxic concentrations of standardized STE and arbutin in human peripheral blood lymphocytes using the apoptosis/necrosis assay, the alkaline comet assay, and the cytokinesis-block micronucleus cytome assay. The STE was also tested for total antioxidant capacity and lipid peroxidation. At a concentration corresponding to the maximum allowable daily intake of arbutin, the tested extract was not cytotoxic, had a negligible potential for causing primary DNA damage and even hindered micronuclei formation in lymphocytes. It also showed a valuable antioxidant capacity, and did not exert marked lipid peroxidation. These promising results represent a solid frame for further development of STE-based herbal preparations. Although arbutin generally had a low DNA damaging potential, the slowing down of lymphocyte proliferation observed after 24 h of exposure points to a cytostatic effect, which merits further research.

  12. HBOC-201 as an alternative to blood transfusion: efficacy and safety evaluation in a multicenter phase III trial in elective orthopedic surgery.

    Science.gov (United States)

    Jahr, Jonathan S; Mackenzie, Colin; Pearce, L Bruce; Pitman, Arkadiy; Greenburg, A Gerson

    2008-06-01

    The ability of hemoglobin based oxygen carrier-201 (HBOC-201) to safely reduce and/or eliminate perioperative transfusion was studied in orthopedic surgery patients. A randomized, single-blind, packed red blood cell (PRBC)-controlled, parallel-group multicenter study was conducted. Six hundred eighty-eight patients were randomized to treatment with HBOC-201 (H, n = 350) or PRBC (R, n = 338) at the first transfusion decision. Primary endpoints were transfusion avoidance and blinded assessment [Mann-Whitney estimator (MW)] of safety noninferiority. Groups were compared directly and by paired/matching group analyses predicated on a prospectively defined dichotomy [treatment success (HH) vs. failure (HR)] in the H arm and an equivalently defined dichotomy [3 (R3+) units PRBC] in the R arm, based on need (moderate vs. high) for additional oxygen carrying capacity. A total of 59.4% of patients in the H arm avoided PRBC transfusion. Adverse events (8.47 vs. 5.88), and serious adverse events (SAEs) (0.35 vs. 0.25) per patient were higher in the H versus R arms (p 80 years), volume overload and undertreatment contributed to this imbalance. HBOC-201 eliminated transfusion in the majority of subjects. The between arms (H vs. R) safety analysis was unfavorable and likely related to patient age, volume overload, and undertreatment and was isolated to patients that could not be managed by HBOC-201 alone. However, patients transfusion when treated with up to 10 units of HBOC-201.

  13. Safety and Observations from a Placebo-Controlled, Crossover Study to Assess Use of Autologous Umbilical Cord Blood Stem Cells to Improve Symptoms in Children with Autism.

    Science.gov (United States)

    Chez, Michael; Lepage, Christopher; Parise, Carol; Dang-Chu, Ashley; Hankins, Andrea; Carroll, Michael

    2018-04-01

    The aim of this exploratory study was to assess the safety and clinical effects of autologous umbilical cord blood (AUCB) infusion in children with idiopathic autism spectrum disorder (ASD). Twenty-nine children 2 to 6 years of age with a confirmed diagnosis of ASD participated in this randomized, blinded, placebo-controlled, crossover trial. Participants were randomized to receive AUCB or placebo, evaluated at baseline, 12, and 24 weeks, received the opposite infusion, then re-evaluated at the same time points. Evaluations included assessments of safety, Expressive One Word Picture Vocabulary Test, 4th edition, Receptive One Word Picture Vocabulary Test, 4th edition, Clinical Global Impression, Stanford-Binet Fluid Reasoning and Knowledge, and the Vineland Adaptive Behavior and Socialization Subscales. Generalized linear models were used to assess the effects of the response variables at the 12- and 24-week time periods under each condition (AUCB, placebo). There were no serious adverse events. There were trends toward improvement, particularly in socialization, but there were no statistically significant differences for any endpoints. The results of this study suggest that autologous umbilical cord infusions are safe for children with ASD. Tightly controlled trials are necessary to further progress the study of AUCB for autism. Stem Cells Translational Medicine 2018;7:333-341. © 2018 The Authors Stem Cells Translational Medicine published by Wiley Periodicals, Inc. on behalf of AlphaMed Press.

  14. Ballistic quality assurance

    International Nuclear Information System (INIS)

    Cassol, E.; Bonnet, J.; Porcheron, D.; Mazeron, J.J.; Peiffert, D.; Alapetite, C.

    2012-01-01

    This review describes the ballistic quality assurance for stereotactic intracranial irradiation treatments delivered with Gamma Knife R either dedicated or adapted medical linear accelerators. Specific and periodic controls should be performed in order to check the mechanical stability for both irradiation and collimation systems. If this step remains under the responsibility of the medical physicist, it should be done in agreement with the manufacturer's technical support. At this time, there are no recent published guidelines. With technological developments, both frequency and accuracy should be assessed in each institution according to the treatment mode: single versus hypo-fractionated dose, circular collimator versus micro-multi-leaf collimators. In addition, 'end-to-end' techniques are mandatory to find the origin of potential discrepancies and to estimate the global ballistic accuracy of the delivered treatment. Indeed, they include frames, non-invasive immobilization devices, localizers, multimodal imaging for delineation and in-room positioning imaging systems. The final precision that could be reasonably achieved is more or less 1 mm. (authors)

  15. Quality assurance and accreditation.

    Science.gov (United States)

    1997-01-01

    In 1996, the Joint Commission International (JCI), which is a partnership between the Joint Commission on Accreditation of Healthcare Organizations and Quality Healthcare Resources, Inc., became one of the contractors of the Quality Assurance Project (QAP). JCI recognizes the link between accreditation and quality, and uses a collaborative approach to help a country develop national quality standards that will improve patient care, satisfy patient-centered objectives, and serve the interest of all affected parties. The implementation of good standards provides support for the good performance of professionals, introduces new ideas for improvement, enhances the quality of patient care, reduces costs, increases efficiency, strengthens public confidence, improves management, and enhances the involvement of the medical staff. Such good standards are objective and measurable; achievable with current resources; adaptable to different institutions and cultures; and demonstrate autonomy, flexibility, and creativity. The QAP offers the opportunity to approach accreditation through research efforts, training programs, and regulatory processes. QAP work in the area of accreditation has been targeted for Zambia, where the goal is to provide equal access to cost-effective, quality health care; Jordan, where a consensus process for the development of standards, guidelines, and policies has been initiated; and Ecuador, where JCI has been asked to help plan an approach to the evaluation and monitoring of the health care delivery system.

  16. Impact of grey zone sample testing by enzyme-linked immunosorbent assay in enhancing blood safety: Experience at a tertiary care hospital in North India.

    Science.gov (United States)

    Solanki, Archana; Singh, Abhay; Chaudhary, Rajendra

    2016-01-01

    Enzyme-linked immunosorbent assay (ELISA) used for screening blood donors for transfusion transmitted infections (TTIs) can sometimes fail to detect blood donors who are recently infected or possessing the low strength of pathogen. Estimation of a grey zone in ELISA testing and repeat testing of grey zone samples can further help in reducing the risks of TTI in countries where nucleic acid amplification testing for TTIs is not feasible. Grey zone samples with optical density (OD) lying between cut-off OD and 10% below the cut-off OD (cut-off OD × 0.9) were identified during routine ELISA testing. On performing repeat ELISA testing on grey zone samples in duplicate, the samples showing both OD value below grey zone were marked nonreactive, and samples showing one or both OD value in the grey zone were marked indeterminate. The samples on repeat testing showing one or both OD above cut-off value were marked positive. About 119 samples (77 for hepatitis B virus [HBV], 23 for human immunodeficiency virus [HIV], and 19 for hepatitis C virus [HCV]) were found to be in grey zone. On repeat testing of these samples in duplicate, 70 (58.8%) samples (45 for HBV, 12 for HIV, and 13 for HCV) were found to be reactive. Six (5%) samples (four for HBV, one for HIV, and one for HCV) were found to be indeterminate. Seventy donors initially screened negative, were found out to be potentially infectious on repeat grey zone testing. Thus, estimation of grey zone samples with repeat testing can further enhance the safety of blood transfusion.

  17. Medical radio-physics. Quality assurance. Transparency; Radiophysique medicale. Assurance de la qualite. Transparence

    Energy Technology Data Exchange (ETDEWEB)

    Krembel, D.

    2009-07-15

    This short presentation, given by the national safety authority (ASN) at the meeting of July 1, 2009 of the high committee for the nuclear safety transparency and information (HCTISN), recalls, first, the missions of the ASN in the medical domain (radiation protection, control and inspections). Then it presents the reactions of the ASN in response to the increase of the number of radiological accidents since 2005: regulation reminder, circular letters, guidebooks, communication to the public and to the mass media. Finally, it defines the main priorities of the ASN with respect to radiotherapy: increase of human resources (radio-physicists shortage), declaration of incidents/accidents, quality assurance for the control of radiation doses delivered to patients, inspection of radiotherapy centres, expertise of new devices, improvement of softwares safety and ergonomics. (J.S.)

  18. Managerial attitude toward quality assurance

    International Nuclear Information System (INIS)

    Kirschenmann, H.J.

    1983-01-01

    This paper will present what relationships exist between the attitude toward quality assurance and the variables of training and experience on the part of managers within the nuclear power industry. Managerial attitude toward quality assurance was measured via questionnaires submitted to managers within architect-engineering, nuclear steam supplier, and constructor firms throughout the United States. The data from the completed questionnaires were statistically analyzed using the chi-square test and conclusions were drawn. Additional study results related to major factors for positive and negative attitudes toward quality assurance will be presented

  19. Quality assurance of polymer concrete

    International Nuclear Information System (INIS)

    Schulz, H.

    1984-01-01

    With polymer concrete, a whole range of organisational and functional measures have to be met in order to assure the required quality with an economic expenditure. Quality assurance begins in the design and does not end in the production, rather includes all fields of the enterprise. The following deals with a particular range of the total complex, the inspection methods for assuring the quality of machine components of polymer concrete, particularly machine tool bases, this being through the control of the raw material, the production and the finished product. (orig.) [de

  20. Quality assurance programme of Temelin nuclear power plant

    International Nuclear Information System (INIS)

    Eybl, J.; Nowak, O.

    1988-01-01

    The fundamental principle of the system of quality assurance in Czechoslovak nuclear power is quality assurance at all stages of the construction and operation of nuclear power plants and the grading fo measures taken, this in dependence on the impact on nuclear safety of the respective nuclear installation or its part. The system has been made fully operational during the construction of nuclear power plants in Temelin and Mochovce. State surveillance is executed by the Czechoslovak Atomic Energy Commission, and the Czech and Slovak Offices for Work Safety. Briefly discussed are the tasks of the building subcontractor of the Temelin nuclear power plant with regard to the programme of quality assurance as well as the results of the solution of the respective research tasks. The programme of quality assurance classifies the selected sections of the structure of a nuclear power plant into three safety categories. No part of the structure is classified into the first category, the second category includes, e.g., the reactor building, cooling tanks and diesel generator units, the third includes the reactor building and the building of auxiliary workshops. Attention is also paid to the problems of the qualification of personnel and to inspection activity. (Z.M.). 12 refs