WorldWideScience

Sample records for assuring blood safety

  1. Reactor system safety assurance

    International Nuclear Information System (INIS)

    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. 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

  3. 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.

  4. Causal Models for Safety Assurance Technologies Project

    Data.gov (United States)

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

  5. Safety Assurance in NextGen

    Science.gov (United States)

    HarrisonFleming, Cody; Spencer, Melissa; Leveson, Nancy; Wilkinson, Chris

    2012-01-01

    The generation of minimum operational, safety, performance, and interoperability requirements is an important aspect of safely integrating new NextGen components into the Communication Navigation Surveillance and Air Traffic Management (CNS/ATM) system. These requirements are used as part of the implementation and approval processes. In addition, they provide guidance to determine the levels of design assurance and performance that are needed for each element of the new NextGen procedures, including aircraft, operator, and Air Navigation and Service Provider. Using the enhanced Airborne Traffic Situational Awareness for InTrail Procedure (ATSA-ITP) as an example, this report describes some limitations of the current process used for generating safety requirements and levels of required design assurance. An alternative process is described, as well as the argument for why the alternative can generate more comprehensive requirements and greater safety assurance than the current approach.

  6. Software Quality Assurance for Nuclear Safety Systems

    International Nuclear Information System (INIS)

    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: (smbullet) Ensures the software processes developed to address nuclear safety in design, operation, construction and maintenance of its facilities are safe (smbullet) Considers the larger system that uses the software and its impacts (smbullet) 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

  7. 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.

  8. Integrating Safety and Mission Assurance in Design

    Science.gov (United States)

    Cianciola, Chris; Crane, Kenneth

    2008-01-01

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

  9. Quality assurance for software important to safety

    International Nuclear Information System (INIS)

    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 how 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

  10. Nuclear power plant safety and reliability assurance

    International Nuclear Information System (INIS)

    The philosophy of nuclear power plant safety is that design should follow established and conservative engineering practices, there should be safety margins in all modes of plant operations, special systems should be provided for response to accidents, and safety systems should have redundant components. This philosophy provides ''defense in depth.'' In recent years, with the accumulation of operating experience and the unexpected complexity of the present generation of light water reactors, the defense in depth philosophy has been supplemented by risk and reliability assessments. Reliability assurance programs based on these probabilistic engineering assessments provide a means of integrating design review, maintenance, testing, replacement of parts, failure reporting, and corrective action, so that the protection of the plant and the public can be systematically ensured

  11. A method of safety assurance for fusion experimental reactor

    International Nuclear Information System (INIS)

    The present report describes safety assurance method for fusion experimental reactor. The ALARA (As Low As Reasonably Achievable) principle for a normal condition and the defence in depth principle for states deviated from the normal condition can be used as basic principles of safety assurance of the reactor. The method includes safety design for systems, importance categorization method to impose suitable demands to their systems, safety evaluation method to validate the design and application of the method. It is considered that this method can be a strong candidate for safety assurance method. (author)

  12. Coalmine Safety Assurance Information System Based on GIS

    Institute of Scientific and Technical Information of China (English)

    LIU Qiao-xi; MAO Shan-jun; MA Ai-nai; MAO Yun-de; BAO Qing-guo

    2003-01-01

    The mine ventilation and safety is one of the most important factors to influence on the coal production.More attention has been paid to manage safety information in scientific, efficient, and real-time way. Therefore, it is important to develop a practical mine safety assurance information system (CSAIS). Based on analyzing the actual management mode for ventilation and safety on mine, the paper studies the structure and function of the mine safety assurance information system based on GIS in detail. Moreover, it also suggests some applications and solutions. By combining with the practical situation, the paper realizes the whole function of the present system.

  13. 78 FR 54510 - New Entrant Safety Assurance Program Operational Test

    Science.gov (United States)

    2013-09-04

    ... Process'' on May 13, 2002 (67 FR 31978), which became effective January 1, 2003. Subpart D of 49 CFR part... determine if the carrier is exercising basic safety management controls. On December 16, 2008 (73 FR 76472... TRANSPORTATION Federal Motor Carrier Safety Administration New Entrant Safety Assurance Program Operational...

  14. Analysis of quality assurance programmes for HIV screening in blood transfusion centres in Delhi.

    OpenAIRE

    Dhingra-Kumar, N.; Sharma, A.K.; N Madan

    1997-01-01

    The safety of blood transfusion has attained tremendous importance because of the problems posed by acquired immunodeficiency syndrome (AIDS) and other transfusion-transmissible diseases. While performing screening tests for human immunodeficiency virus (HIV) antibodies in donated blood is indispensable, it is also essential to introduce an effective quality assurance programme covering inspection of specimens, review of record-keeping, maintenance of equipment, and verification of results. W...

  15. Viral metagenomics and blood safety.

    Science.gov (United States)

    Sauvage, V; Eloit, M

    2016-02-01

    The characterization of the human blood-associated viral community (also called blood virome) is essential for epidemiological surveillance and to anticipate new potential threats for blood transfusion safety. Currently, the risk of blood-borne agent transmission of well-known viruses (HBV, HCV, HIV and HTLV) can be considered as under control in high-resource countries. However, other viruses unknown or unsuspected may be transmitted to recipients by blood-derived products. This is particularly relevant considering that a significant proportion of transfused patients are immunocompromised and more frequently subjected to fatal outcomes. Several measures to prevent transfusion transmission of unknown viruses have been implemented including the exclusion of at-risk donors, leukocyte reduction of donor blood, and physicochemical treatment of the different blood components. However, up to now there is no universal method for pathogen inactivation, which would be applicable for all types of blood components and, equally effective for all viral families. In addition, among available inactivation procedures of viral genomes, some of them are recognized to be less effective on non-enveloped viruses, and inadequate to inactivate higher viral titers in plasma pools or derivatives. Given this, there is the need to implement new methodologies for the discovery of unknown viruses that may affect blood transfusion. Viral metagenomics combined with High Throughput Sequencing appears as a promising approach for the identification and global surveillance of new and/or unexpected viruses that could impair blood transfusion safety. PMID:26778104

  16. The regulatory goal of assuring nuclear safety

    International Nuclear Information System (INIS)

    The fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear facilities are operated, as well as decommissioned, in an acceptably safe manner. However, in meeting this objective the regulator must keep in mind that it is the operator that has responsibility for safely operating a nuclear facility; the role of the regulator is to oversee the operator activities as related to assuming that responsibility. There are currently many sources of information available to the regulator pertaining to safety at any given nuclear facility, such as inspection reports, operating experience reports, research results, periodic safety reviews, probabilistic safety analysis (PSA) results, insights from IAEA reviews and other similar information. A major challenge for the regulator is to systematically collect and analyse this information in order to arrive at an integrated assessment of the level of safety of the particular facility and then to make a judgement about its acceptability. In order to assist member countries in addressing this challenging question, the Committee on Nuclear Regulatory Activities (CNRA) of the OECD Nuclear Energy Agency (NEA) has sponsored this report. The primary focus of the report is on how the regulatory body can systematically collect and make an integrated analysis of all the relevant safety information available to it and arrive at a sound judgement on the acceptability of the level of safety of the facilities that it regulates. It therefore follows that the target audience for this report is primarily nuclear regulators, although the information and ideas may also be of interest to nuclear operators, other nuclear industry organisations and segments of civil society. (author)

  17. 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.

  18. 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 m

  19. NATURAL GAS STORAGE ROLE IN ENERGY SAFETY ASSURANCE IN POLAND

    OpenAIRE

    Stanis³aw Brzeziñski

    2008-01-01

    : In the paper author considers possibility of natural gas storage in natural underground stores in large scale. The author presents natural gas stores in Poland with their technical and economical features and chances of their extension. He also presents influence of large scale gas storage on energy safety assurance.

  20. Assurance of environmental safety through containment

    International Nuclear Information System (INIS)

    In the initial years of nuclear power stations, safety strategy focused on ''design basis accidents'' which incorporated a broad scenario of accident possibilities, and which acted as an envelope for all accidents taken into account during the licensing procedure. The later sixties began consideration of accidents beyond the design basis accidents. These severe accidents could be assumed to be the result of an accident coupled with an independent and extensive failure of protection and safety systems. Containments and their safeguard systems have been designed for radiation source terms which could only occur under some severe accident conditions. However, containments to date have not been designed for the mechanical and thermal loads that could accompany severe accidents. Containments will be capable of accommodating the effects of severe accidents with relatively modest changes to the present containment designs, many of which changes are already contemplated in the next generation plants

  1. 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

  2. Quality assurance - the key to safety and availability during operation

    International Nuclear Information System (INIS)

    Social demands require that the trust and acceptance of the critical general public be attained by demonstrating the safety and quality of nuclear installations. Efforts in recent years have therefore focused on thorough (planning, erection, operation) quality assurance as part of an effective system analysis. Here logistical QA management of the operation of nuclear power plants assumes a key role in terms of safety and availability. The QA option also enables enhancement of cost-effectiveness in all process-oriented areas from production, preventive and corrective maintenance to plant monitoring and in-service inspections. Quality assurance is therefore synonymous with organizational, personnel and technical aspects of plant management. Selected examples are used to illustrate where quality assurance can make valuable contributions to improving plant management: plant organization and the description of relevant work sequences; man/machine interface and the importance of communication; selective maintenance and in-service inspections with reliable information on quality; updating of plant documentation; quality audit by QA specialists as a monitoring and feedback system. (author). 16 figs., 5 refs

  3. 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.

  4. Assuring fish safety and quality in international fish trade

    International Nuclear Information System (INIS)

    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

  5. 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.

  6. 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.

  7. Building a Culture of Patient Safety - Report of the Commission on Patient Safety and Quality Assurance

    OpenAIRE

    Department of Health

    2008-01-01

    The Commission on Patient Safety and Quality Assurance was established in January 2007 and reported to the Minister in July 2008. The report was considered by government in January 2009 which agreed the implementation process. The overall objective of the Commission was to develop clear and practical recommendations to ensure that safety and quality of care for patients is paramount within the healthcare system. The Commission’s report set out a wide range of policy measures that will d...

  8. Assuring future competence in nuclear safety in Finland

    International Nuclear Information System (INIS)

    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

  9. Software quality assurance plans for safety-critical software

    International Nuclear Information System (INIS)

    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 TELEPERMR 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

  10. 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.

  11. 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.

  12. 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). PMID:21113564

  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. PMID:23171300

  14. 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.

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

    Science.gov (United States)

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

    2014-11-01

    The French military blood institute (FMBI) is the only military blood supplier in France. FMBI operates independently and autonomously under the Ministry of Defense's supervision, and accordingly, to the French, European and NATO technical and safety guidelines. FMBI is in charge of the collection, preparation and distribution of blood products to supply transfusion support to armed forces, especially during overseas operations. In overseas military, a primary physician is responsible for haemovigilance in permanent relation with an expert in the FMBI to manage any adverse reaction. Additionally, traceability of delivered or collected blood products during overseas operation represents a priority, allowing an appropriate management of transfusion inquiries and assessment of practices aiming to improve and update procedures and training. Transfusion safety in overseas operation is based on regular and specific training of people concerned by blood supply chain in exceptional situation. PMID:25284434

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

    International Nuclear Information System (INIS)

    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

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

    International Nuclear Information System (INIS)

    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 2nd, 3th, and 4th 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

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

    International Nuclear Information System (INIS)

    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)

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

    International Nuclear Information System (INIS)

    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)

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

    International Nuclear Information System (INIS)

    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

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

    International Nuclear Information System (INIS)

    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

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

    International Nuclear Information System (INIS)

    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

  3. [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. PMID:25578550

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

    International Nuclear Information System (INIS)

    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

  5. Assuring consumer safety without animals: Applications for tissue engineering

    OpenAIRE

    Westmoreland, Carl; Holmes, Anthony M

    2009-01-01

    Humans are exposed to a variety of chemicals in their everyday lives through interactions with the environment and through the use of consumer products. It is a basic requirement that these products are tested to assure they are safe under normal and reasonably foreseeable conditions of use. Within the European Union, the majority of tests used for generating toxicological data rely on animals. However recent changes in legislation (e.g., 7th amendment of the Cosmetics Directive and REACH) ar...

  6. Safety in radiation therapy: quality assurance of computerized system

    International Nuclear Information System (INIS)

    The development of computerized systems in radiotherapy opens new challenging possibilities. There is however a major risk of specific errors if the use of such systems is not properly controlled. On the other hand, the software sophistication, such as encountered in modern treatment planning systems (TPS), makes it very difficult to set up efficient quality assurance programs compatible with the workload of users in charge of daily routine. From the analysis of previous accidents involving TPS, we can conclude that the major risks are erroneous calculations of monitor units resulting from a poor understanding of the software capabilities combined to a lack of vigilance with respect to the data obtained from a computer. To reduce the risks, it is necessary to setup a comprehensive quality assurance program covering all steps of the process, including commissioning of a new system and systematic checks of individual treatment plans. Such a program offers the users the opportunity to acquire a deeper understanding of the system and avoid potential pitfalls. There is presently a lack of consensus for an international protocol related to quality assurance of computerized systems in radiotherapy. It is therefore important to define protocols at the national level, with special consideration of the aspects which are more likely to generate significant errors. (author)

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

    International Nuclear Information System (INIS)

    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)

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

    International Nuclear Information System (INIS)

    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)

  9. 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).

  10. Management of National Nuclear Power Programs for assured safety

    International Nuclear Information System (INIS)

    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)

  11. Implementation of quality assurance program for operational safety of P2TBDU installation

    International Nuclear Information System (INIS)

    According to Decree of Head of BAPETEN No : 07/Ka-BAPETEN/V-99 which determines the duties to perform the quality assurance function for each nuclear installation, the Head of P2TBDU has decided to perform and maintain the quality assurance program controlling each activity which may influence the safety. The P2TBDU Quality Assurance Program has been arranged and put into force since 1993, however the implementation of the program has not been effective as expected. The change of organization structure shall cause the changes of organisation's function and main duty, therefore it requires that the change/revision be made to accommodate the new policy on the quality assurance program. The Quality Assurance Program revision 1 has been arranged and put into force since Nov. 19, 1999 which incorporated the change of the organizational structure. The effectiveness of implementation of the program shall extremely be determined y commitment of the P2TBDU management as well as awareness of each personal of the organization on the necessity of Quality Assurance Program for operational safety of the installation. (author)

  12. 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.

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

    Science.gov (United States)

    Kimura, Aya Hirata

    2012-01-01

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

  14. The Development of Quality Assurance and Visualization for Safety Assessment System

    International Nuclear Information System (INIS)

    Site Information and Total Environmental data management System (SITES) is an integrated program for overall data acquisition, environmental monitoring, and safety analysis. SITES is composed of three main modules such as site database system, safety assessment system and environmental monitoring system named SECURE, SAINT and SUDAL, respectively. SAINT abbreviated for Safety Assessment Integration system is the integrated interface for the radioactive waste safety assessment codes in the SITES. SAINT is developed for the application and analysis of data from SECURE and for the systematic management of the resulted data from the safety assessment. The Quality Assurance module in SAINT is implemented to enhance the reliability of safety assessment results. The visualization in SAINT is purposed of reliability, comprehension of safety assessment results and user's convenience which can easily recognize the assessment results using the geographic information. (authors)

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

    International Nuclear Information System (INIS)

    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

  16. Safety assurance of RBMK-type NPPs against explosion effects

    International Nuclear Information System (INIS)

    This presentation covers the following subjects: concept of the RBMK type NPPs safety under special impacts; analysis of potential sources of air impact wave for RBMK type category 1 buildings and structures, analysis of explosive danger sources located on the NPP site; analysis of explosive danger sources on ground transport main roads; outside the NPP site; from marine water area; analysis of loads acting on category 1 RBMK type NPP building constructions at spontaneous explosion. The loading level and design limits are compared. According to calculations the effect of air impact wave from existing potential sources of explosion can be dangerous for RBMK type NPP building and structures. Preliminary assessment had shown that strengthening the building supporting structures up to level required for safety is connected with a considerable work. An alternative is proposed, to develop complex administrative and technical measures for decreasing the air impact wave loads on the basis of marginal distance principle. The obtained experimental values would allow specification of design models of behaviour of RBMK type buildings and structures under spontaneous explosion effects

  17. Modern Approaches to Safety Assurance of a New Generation of Sodium Fast Reactors

    International Nuclear Information System (INIS)

    In the stage of designing sodium cooled fast reactors (SFRs) of a new generation there is a task to improve their inherent safety up to the level higher than that of the previous SFR designs. Modern safety requirements to the SFR of the fourth generation are described. Through the example of the BN-1200 reactor, approaches to safety assurance are demonstrated using development of inherent safety properties up to a brand new level compared to that of the earlier commercial reactor designs (BN-600 and BN-800). Also, passive safety devices and systems applied in the BN-1200 design are described. The goal is to eliminate the necessity for evacuation of residents under conditions of any possible realistic accidents. The paper presents properties of inherent self-protection of the BN-1200 reactor and estimation of their effectiveness in terms of safety assurance. The basic design approaches concerning safety are considered, including additional measures as applied to the BN-1200 reactor. These include measures aimed at the elimination or minimization of sodium leaks; design approaches to the passive shutdown systems (PSS) using various operation principles, namely: hydraulically suspended absorber rods operating in case of coolant flow rate decrease (PSS-H) and absorber rods operating in the case of increase of the core outlet coolant temperature above a certain value (PSS-T); passive decay heat removal system; sodium plenum above the core; gastight compartment above the reactor; core catcher made of refractory metal; and reactor guard vessel. (author)

  18. 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.

  19. Assuring future competence in nuclear safety in Finland

    International Nuclear Information System (INIS)

    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

  20. The laboratory is a key partner in assuring patient safety.

    Science.gov (United States)

    Stankovic, Ana K

    2004-12-01

    Medical errors have a great impact on patient outcomes. They can cause serious injury to patients or even result in their deaths. However, morbidity and mortality can sometimes be prevented by the timely and effective action of health care workers. Several IOM Reports have focused on the problem of errors in the United States health care system and identified gaps that need to be addressed. As part of the overall health care system, clinical laboratories are vulnerable to medical errors. Because of significant efforts on the part of both the laboratories and the manufacturers of laboratory equipment and reagents, the errors in the analytic phase of the total testing process now represent the smallest portion of testing errors. Currently, laboratory testing errors occur most frequently in the preanalytic phase. The primary reason for the high prevalence of preanalytic errors is that, at the present time, it is difficult to monitor all preanalytic variables and to implement necessary improvement processes, particularly when some of the variables (like phlebotomy) are not under the control of the laboratory. Considerable efforts have been made by laboratory professionals and other stakeholders to decrease testing errors. Minimal quality requirements have been set through regulations for both laboratory testing and the manufacture of medical equipment and reagents. At the same time, nonregulatory approaches have greatly affected the quality of laboratory testing. These include laboratory standards, various quality improvement programs, voluntary reporting of adverse events, and, in the near future, the National Report on the Quality of Laboratory Services. The introduction of successful approaches from other industries, such as Six Sigma and Lean, also will help reduce the rate of laboratory errors. The clinical laboratory has done more than most other sectors of health care to decrease the occurrence of medical errors, making it a key partner inpatient safety. PMID

  1. FDA'S food ingredient approval process: Safety assurance based on scientific assessment.

    Science.gov (United States)

    Rulis, Alan M; Levitt, Joseph A

    2009-02-01

    Fifty years ago, the Food and Drug Administration (FDA) began implementing new provisions of the Federal Food, Drug, and Cosmetic Act aimed at assuring the safety of new food additives before they enter the marketplace. Today, the agency's procedures for premarket evaluation of food additive safety have evolved into a scientifically rigorous, sound and dependable system whose objective and independent evaluations by FDA scientists assure that new food additives are safe for their intended uses before they arrive on the consumer's plate. Although controversy often surrounds food additives in the popular media and culture, and science-based challenges to FDA's decisions do arise, the agency's original safety judgments successfully withstand these challenges time and again. This article reviews the basic components of the FDA's decision-making process for evaluating the safety of new food additives, and identifies characteristics of this process that are central to assuring that FDA's decisions are marked by scientific rigor and high integrity, and can continue to be relied on by consumers. PMID:18983884

  2. 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)

    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

  3. 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)

    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

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

    International Nuclear Information System (INIS)

    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

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

    International Nuclear Information System (INIS)

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

    International Nuclear Information System (INIS)

    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

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

    OpenAIRE

    Sonawane A; Singh Meghraj; Kumar J. V. K.; Kulkarni Arti; Shirva V; Pradhan A

    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 rev...

  8. 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.

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

    International Nuclear Information System (INIS)

    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)

  10. 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.

  11. Quality Assurance for the Safety and Security of Radioactive Sources in Pakistan

    International Nuclear Information System (INIS)

    The paper deals with the safety and security of radioactive sources that are used by different establishments of Pakistan Atomic Energy Commission (PAEC), with emphasis on the quality assurance to make their best use for the benefit of humans and to eliminate the risk of their malicious use to protect people and environment, as per IAEA recommendation. The outcome of this study identifies the strengths and good practices used in PAEC establishments for safety and security of radioactive sources. It also identifies the gaps that exist between present practices and in the codes and guidelines of the IAEA and the Pakistan Nuclear Regulatory Authority. (author)

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

    International Nuclear Information System (INIS)

    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)

  13. International small dam safety assurance policy benchmarks to avoid dam failure flood disasters in developing countries

    Science.gov (United States)

    Pisaniello, John D.; Dam, Tuyet Thi; Tingey-Holyoak, Joanne L.

    2015-12-01

    In developing countries small dam failure disasters are common yet research on their dam safety management is lacking. This paper reviews available small dam safety assurance policy benchmarks from international literature, synthesises them for applicability in developing countries, and provides example application through a case study of Vietnam. Generic models from 'minimum' to 'best' practice (Pisaniello, 1997) are synthesised with the World Bank's 'essential' and 'desirable' elements (Bradlow et al., 2002) leading to novel policy analysis and design criteria for developing countries. The case study involved 22 on-site dam surveys finding micro level physical and management inadequacies that indicates macro dam safety management policy performs far below the minimum benchmark in Vietnam. Moving assurance policy towards 'best practice' is necessary to improve the safety of Vietnam's considerable number of hazardous dams to acceptable community standards, but firstly achieving 'minimum practice' per the developed guidance is essential. The policy analysis/design process provides an exemplar for other developing countries to follow for avoiding dam failure flood disasters.

  14. Safety assurance for a modern NPP design with WWER-1000 reactor

    International Nuclear Information System (INIS)

    Conclusion: In the design of active safety systems the following requirements should be considered: All system should have 4 components, each for a specific determined function; The number of components is determined on the base of a single failure; assurance of spatial separation of the safety systems and built-in protection of the channels preventing the possibility of common cause failure (fire, flooding); the control system should be designed to be safe in case of failure; for minimizing the human error, there should be automated systems for blocking the operator’s actions which violate the implementation of the safety functions; the safety system is equipped with independent power supply (diesel generator), design according to the requirements of the safety system. The quality of the safety is improved by using of passive safety systems: double containment; 8 additional backs for core cooling; 12 heat exchangers for passive heat removal for unlimited period; new passive system for boron insertion for bringing the reactor in sub-critical condition

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

    International Nuclear Information System (INIS)

    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

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

    International Nuclear Information System (INIS)

    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

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

    International Nuclear Information System (INIS)

    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 238PuO2-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

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

    International Nuclear Information System (INIS)

    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)

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

    Science.gov (United States)

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

    2015-03-01

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

  20. 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.

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

    International Nuclear Information System (INIS)

    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)

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

    Science.gov (United States)

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

    2014-02-01

    Social and economic development, along with increased health care coverage, has caused a sharp increase in the clinical demand for blood in China. Whole blood collection has increased rapidly in the past decade but has failed to keep pace with the ever-increasing demand. Overall, the country's blood safety has been improved with 99% of whole blood donations collected from voluntary unpaid donors. However, the unmet clinical demand for blood and the increasing incidence of human immunodeficiency virus and syphilis in the general population pose new challenges to China's blood banking system. To ensure a safe and adequate blood supply, continued efforts are required to recruit and retain a sufficient number of low-risk voluntary blood donors, improve donor prescreening and blood testing process, ease donor restrictions, and strengthen patient blood management. PMID:23710600

  3. 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)

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

    International Nuclear Information System (INIS)

    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)

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

    International Nuclear Information System (INIS)

    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

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

    International Nuclear Information System (INIS)

    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)

  7. Quality assurance of nuclear power plants - an important factor for nuclear safety and radiation protection

    International Nuclear Information System (INIS)

    The nuclear technology may have some undesirable effects on society with the long term storage and deposition of long lived radioactive wastes as well as with some nonproliferation issues. One of the most important factors influencing the safety of a nuclear power plant is the correct and reliable functioning of the control and safety systems including all I≅C equipment inside the plant and in the controlled environment outside the plant. In fact during normal operation these systems substitute the operator's control of the NPP and give time to the operators to perform the necessary calculations and take the proper measures to ensure the desired operational status. In this respect it is particularly important that all these systems and instrumentation are properly qualified so that all the information regarding the reliability, operability, seismic protection etc. can be correct and the algorithms installed in the safety systems can function properly and effectively. A special concern is the proper qualification of the radiation protection equipment because this directly influences the health of the operating personnel. The report presents some important requirements concerning quality assurance and qualification of I≅C systems in the Kozloduy NPP, as well as the way this is supervised in Bulgaria. (author)

  8. Probability of loss of assured safety in temperature dependent systems with multiple weak and strong links.

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, Jay Dean (ProStat, Mesa, AZ); Oberkampf, William Louis; Helton, Jon Craig (Arizona State University, Tempe, AZ)

    2004-12-01

    Relationships to determine the probability that a weak link (WL)/strong link (SL) safety system will fail to function as intended in a fire environment are investigated. In the systems under study, failure of the WL system before failure of the SL system is intended to render the overall system inoperational and thus prevent the possible occurrence of accidents with potentially serious consequences. Formal developments of the probability that the WL system fails to deactivate the overall system before failure of the SL system (i.e., the probability of loss of assured safety, PLOAS) are presented for several WWSL configurations: (i) one WL, one SL, (ii) multiple WLs, multiple SLs with failure of any SL before any WL constituting failure of the safety system, (iii) multiple WLs, multiple SLs with failure of all SLs before any WL constituting failure of the safety system, and (iv) multiple WLs, multiple SLs and multiple sublinks in each SL with failure of any sublink constituting failure of the associated SL and failure of all SLs before failure of any WL constituting failure of the safety system. The indicated probabilities derive from time-dependent temperatures in the WL/SL system and variability (i.e., aleatory uncertainty) in the temperatures at which the individual components of this system fail and are formally defined as multidimensional integrals. Numerical procedures based on quadrature (i.e., trapezoidal rule, Simpson's rule) and also on Monte Carlo techniques (i.e., simple random sampling, importance sampling) are described and illustrated for the evaluation of these integrals. Example uncertainty and sensitivity analyses for PLOAS involving the representation of uncertainty (i.e., epistemic uncertainty) with probability theory and also with evidence theory are presented.

  9. Blood safety in the United States: Current status and challenges

    Institute of Scientific and Technical Information of China (English)

    R. Y. Dodd

    2010-01-01

    @@ Introduction Since the emergence of AIDS/HIV in the 1980s,blood safety has been considered to be a priority in the Unit-ed States (US). Not only is a great deal of attention paid to the major transfusion transmissible infections,but there is also concern about emerging infections.Although blood is collected by a range of independent organizations in the US, it is highly regulated by the US Food and Drug Administration and most blood collec-tion agencies are also subject to voluntary accreditation through professional organizations such as AABB.

  10. Assuring CANDU nuclear safety competence in Korea: regulatory research and development program

    International Nuclear Information System (INIS)

    According to a two-reactor policy developed in the late 1980s in Korea, the national short and mid-term power reactor strategy has been established in such a way PWR should play a principal role in the development of nuclear power plants and CANDU a supplementary role taking advantage of its localization potentials. However, the diversification of reactor types and vendors has caused some difficulties in the process of the individual nuclear power plants licensing and regulation. During the licensing of Wolsong units 2, 3 and 4, every effort has been made to harmonize the Canadian regulations with those of Korea by establishing the various and specific regulatory positions and guidelines. The safety assuring method of CANDU reactors has been improved subatantially through these efforts, resulting in the improvement of regulatory system and procedure in Korea. However, the incident of heavy water leaks from Wolsong unit 3 in October 1999 and recently raised CANDU generic safety issues, such as feeder wall thinning, have motivated the need to re-emphasize the operational safety of CANDUs. As the necessity of improving and developing regulatory requirements, procedures, and technologies considering the design and operating characteristics of CANDUs was recognized, a need of a new mid-and long-term R and D program with an aim to develop and improve regulatory infrastructure such as legal system, generic regulatory requirements and technical standards for CANDUs was sought. The regulatory research programs for CANDUs were launched last August and the 1st phase of the project will go on to March 2002. The R and D program consists of four sub-programs; (i) development of regulatory requirments and technical standard, (ii) development of regulatory inspection manuals, (iii) development of performance indicators (PIs), and (iv) development of Safety Review Guides(SRGs). In this paper, the overview of the mid- and long-term regulatory R and D program for CANDU NPPs and its

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

    International Nuclear Information System (INIS)

    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)

  12. 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. PMID:21170188

  13. 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.

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

    International Nuclear Information System (INIS)

    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

  15. 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)

  16. The Role of R and D Technical Support for the Assessment, Assurance and Improvement of Nuclear Installation Safety

    International Nuclear Information System (INIS)

    In the introduction of this paper some specific safety aspects of CANDU Cernavoda NPP are considered, emphasizing the importance and the contents of the technical support, including R and D components, for the assessment, assurance and the continued improvement of the nuclear installations safety on a medium and long term basis, with references to the Convention on nuclear safety. It focuses on techniques of nuclear safety assessment, as an essentially step for periodic verification of nuclear safety and the identification of the measures for assurance and improvements of nuclear safety. Considered as an important component of the technical support, the R and D activity in INR Pitesti devoted to the Cernavoda NPP nuclear safety has as main objectives the maintenance and development of the methods and evaluation tools used for the prediction of the plant behavior during accident conditions as well as maintenance and development of the experimental data for different plant components. In this respect the main activities carried out at INR Pitesti in the frame of the nuclear safety and reactor physics R and D program are presented. It is emphasized the importance of maintaining and developing a national competence in the field in order to provide a technical support on a medium and long term basis for a safe operation of the nuclear power plant as well as for a further consolidation of a positive perception of the public for nuclear power

  17. 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.

  18. 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.

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

    International Nuclear Information System (INIS)

    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

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

    International Nuclear Information System (INIS)

    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)

  1. 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. PMID:23612449

  2. Argonne National Laboratory Internal Appraisal Program environment, safety, health/quality assurance oversight

    Energy Technology Data Exchange (ETDEWEB)

    Winner, G.L.; Siegfried, Y.S.; Forst, S.P.; Meshenberg, M.J.

    1995-06-01

    Argonne National Laboratory`s Internal Appraisal Program has developed a quality assurance team member training program. This program has been developed to provide training to non-quality assurance professionals. Upon successful completion of this training and approval of the Internal Appraisal Program Manager, these personnel are considered qualified to assist in the conduct of quality assurance assessments. The training program has been incorporated into a self-paced, computerized, training session.

  3. Decree of the Czechoslovak Atomic Energy Commission No. 436/1990 on quality assurance of selected facilities with respect to nuclear safety of nuclear facilities

    International Nuclear Information System (INIS)

    The Decree specifies basic quality assurance requirements applicable to machines, their parts and materials, civil engineering structures, means for automated control of technological processes including hardware and software, and electricity supply systems related to nuclear safety of nuclear facilities, and stipulates binding procedures for the implementation of technical and organizational provisions associated with the quality of selected equipment to ensure nuclear safety of nuclear facilities. Safety classes are defined for selected equipment. Requirements laid on safety assurance documentation are specified, and requirements placed on safety assurance programmes, their preparation, finalization and approval are defined. Quality assurance requirements are also specified with respect to the designing, manufacture, construction, operation, repair, modification and decommissioning of nuclear facilities. The Decree entered into force on 1 December 1990. (J.B.)

  4. 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)

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1978-12-01

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

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

    Science.gov (United States)

    Devine, Dana V; Schubert, Peter

    2016-06-01

    Pathogen inactivation technologies represent a shift in blood safety from a reactive approach to a proactive protective strategy. Commercially available technologies demonstrate effective killing of most viruses, bacteria, and parasites and are capable of inactivating passenger leukocytes in blood products. The use of pathogen inactivation causes a decrease in the parameters of products that can be readily measured in laboratory assays but that do not seem to cause any alteration in hemostatic effect of plasma or platelet transfusions. Effort needs to be made to further develop these technologies so that the negative quality impact is ameliorated without reducing the pathogen inactivation effectiveness. PMID:27112999

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

    International Nuclear Information System (INIS)

    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

  8. Assuring nuclear safety education into the 21st century in Sweden

    International Nuclear Information System (INIS)

    Full text: In many countries in the Western world there has been a concern for the future competence in nuclear safety in particular and nuclear technology in general. There have been many reasons for this concern, i.e. nuclear power has been debated in many countries, declining research in nuclear safety - and technology area, retiring professors are not replaced and in the case of Sweden the parliament has decided to phase out nuclear power (which resulted in that Barsebaeck 1 reactor was shut down in 1999). Since the beginning of the 1990's the Swedish Centre for Nuclear Technology (SKC) was established and financed by SKI, ABB-Atom (later Westinghouse) and the Swedish utilities. The purpose was to support PhD students with full PhD grants in topics related to nuclear technology. The budget was in the year 2001 about 10 MSEK/year. In Sweden the Government's appropriations directive to SKI for 2001 (and the following years) states that 'SKI shall take action to ensure that the competence required for the safety and non-proliferation work is maintained and developed within SKI as well as at the licensees and elsewhere in the country'. From an educational point of view the year 2001 was a crucial year since undergraduate and postgraduate education at universities and institutes of technology wound up in the risk zone when several professors in nuclear subjects retired. In this situation the Royal Institute of Technology (KTH) announced that financial support was needed in order to fill some of these positions. This applied to the professorships in Nuclear Chemistry and Reactor Technology at KTH. KTH also needed support for the professorship in Reactor Physics. Chalmers University in Technology (Chalmers), on the other hand, had decided to appoint a replacement for the professorship in Nuclear Chemistry. This situation was resolved for the professorship in Nuclear Chemistry at KTH as the Swedish Nuclear Fuel and Waste Management Company decided to support this

  9. 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.

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

    Directory of Open Access Journals (Sweden)

    Asa'ah Nkohkwo

    2016-02-01

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

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

    Science.gov (United States)

    2010-07-01

    ... includes the following: (i) Surface safety valves (SSV) and actuators; (ii) Underwater safety valves (USV..., remanufacturing, or hot work such as welding, you must replace it with certified SPPE. (c) Recognizing...

  12. Implementation of human factors activities for assuring nuclear and radiation safety

    International Nuclear Information System (INIS)

    Implementation of safety culture in the nuclear and radiation facilities should be achieved by introduction of organizational, educational, fitness for duty and recruitment measures focused to the safety goal. Adequate level of nuclear and radiation safety should be achieved by changes in working procedures, level of knowledge, the way of communication and the level of individual working availability. These changes demand modifications of workers' attitudes and facility's policy to the safety and these changes lead to the implementation of safety culture. (author). 3 refs

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

    International Nuclear Information System (INIS)

    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.)

  14. 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 

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

    International Nuclear Information System (INIS)

    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)

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

    International Nuclear Information System (INIS)

    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)

  17. Safety Assurance Factors for Electronic Health Record Resilience (SAFER): study protocol

    OpenAIRE

    Singh, Hardeep; Ash, Joan S.; Sittig, Dean F.

    2013-01-01

    Background Implementation and use of electronic health records (EHRs) could lead to potential improvements in quality of care. However, the use of EHRs also introduces unique and often unexpected patient safety risks. Proactive assessment of risks and vulnerabilities can help address potential EHR-related safety hazards before harm occurs; however, current risk assessment methods are underdeveloped. The overall objective of this project is to develop and validate proactive assessment tools to...

  18. 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. PMID:24389794

  19. Quick assessment tool for assurance of structural safety in the building process

    NARCIS (Netherlands)

    Terwel, K.C.; Jansen, S.J.T.

    2014-01-01

    From forensic investigation it is known that many structural failures can be attributed to human errors and organizational factors. To provide project leaders with information on the current state of factors in the building process influencing structural safety, we developed a quick assessment tool.

  20. A study of the noncompliance of blood banks on safety and quality parameters in blood donation camps in Bengaluru

    Directory of Open Access Journals (Sweden)

    Rajat Kumar Agarwal

    2015-01-01

    Full Text Available Aims: The compliance of safety and quality parameters laid out by national and international guidelines in outdoor blood donation camps has not been studied in India. Our study aimed at identifying, monitoring, analyzing, and developing preventive strategies for several key parameters associated with the quality and safety of outdoor voluntary blood donation camps (VBDC. Settings: The study covered a total of 424 VBDCs at various locations in Bengaluru, Karnataka (South India from 2009 to 2013. Seven government hospitals based blood banks, three private hospitals based blood banks and two voluntary standalone blood banks participated in the VBDCs included in the study. Materials and Methods: At the onset, the quality and safety standards to be followed were discussed and agreed upon. During the study, noncompliance (NC to the agreed upon standards were recorded and shared. Periodic trainings were also organized to help minimize NC. Results: One or more instances of NC in 73% of the VBDCs. Highest NC were observed associated with punctuality (34%, wearing gloves (16%, hemoglobin (Hb estimation (11% and donor screening and selection other than Hb check (8-9%. Conclusion: For all 16 parameters under study, significant NC was observed. As a whole private hospital based blood banks were more noncompliant. The high degree of NC to matters relating to quality and safety in VBDCs is high and warrants for urgent attention and further study. Our study also shows that regular monitoring and systematic and strategic intervention can decrease the rate of NC.

  1. Comments upon the Ordinance on the Assurance of Atomic Safety and Radiation Protection

    International Nuclear Information System (INIS)

    The comments centre upon the provisions governing responsibilities in the use of atomic energy and the protection against its hazards; licensing, governmental surveillance, and monitoring; radiation protection and nuclear safety; radiation protection limit values; and requirements on qualification and further training. They outline the functions of the National Board for Atomic Safety and Radiation Protection as the regulatory body of the Council of Ministers of the German Democratic Republic; the provisions laid down to protect workers, the population and the environment; and the scientific foundations of limit values. Moreover, they set out the possibilities under administrative law, and the action provided for by criminal law, to enforce the pertinent legal regulations. An annex covers legal regulations and guidelines relating to special uses of atomic energy. References and a subject index complete the comments

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

    International Nuclear Information System (INIS)

    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. PMID:19025323

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

    International Nuclear Information System (INIS)

    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)

    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. 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

    ,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 an...... selection criteria for blood donation. Blood donors recruited in more recent years exhibited a lower relative mortality than those who started earlier. CONCLUSION: Blood donors enjoy better than average health. Explicit and informal requirements for blood donation in Scandinavia, although mostly of a simple......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...

  7. Revitalizing quality assurance

    International Nuclear Information System (INIS)

    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)

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

    International Nuclear Information System (INIS)

    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

  9. Investments in blood safety improve the availability of blood to underserved areas in a sub-saharan african country

    NARCIS (Netherlands)

    Pitman, J.P.; Wilkinson, R.L.; Basavaraju, S.V.; Von Finckenstein, B.G.; Sibinga, C.T.H.; Marfin, A.; Postma, M.J.; Mataranyika, M.N.; Tobias, J.L.

    2014-01-01

    Background: Since 2004, several African countries, including Namibia, have received assistance from the U.S. President's Emergency Plan for AIDS Relief (PEPFAR). Aims: Gains have been documented in the safety and number of collected units in these countries, but the distribution of blood has not bee

  10. An outline of a risk assessment-based system of meat safety assurance and its future prospects.

    Science.gov (United States)

    Berends, B R; van Knapen, F

    1999-10-01

    Discussed are the outlines of a risk assessment-based system of meat safety assurance to replace the current meat inspection. An example of a system that uses the Hazard Analysis of Critical Control Points (HACCP)-principles in the entire production chain from stable to table is also given. Continuous evaluation of risks is the main driving force of the new system. Only then the system has the means to remain flexible and provide for the data necessary to convince trade partners that the products they buy are safe. A monitoring system that keeps track of the important health hazards in the entire chain from stable to table is therefore necessary. This includes monitoring of cases of disease in the human population caused by the hazardous agents of concern. Coordination of the monitoring and control and processing of the information is done by an independent body. Furthermore, the system demands a production from stable to table that is based on the ideas of Integrated Quality Control (IQC), HACCP, and certification of production processes and quality control procedures. Clear legislation provides for criteria about acceptable or unacceptable health risks for the consumer and determines at what moments which risks should be controlled by the producers. Simultaneously, the legislation has to be flexible enough to be able to adapt quickly to any changes in risks, or in the way risks should be controlled. In the new system current meat inspection can easily be carried out by employees of the slaughter houses and is no longer a direct responsibility of the authorities. The authorities only demand certain safety levels and verify whether producers stick to these. Producers remain fully responsible for the safety and quality of their products, and fully liable in case of any damage to the consumers' health. However, it is to be expected that some EU Member-States miss the organizational and agricultural basis for a successful application of the new system. Consequences

  11. Medicinal plants in the treatment of women's disorders: Analytical strategies to assure quality, safety and efficacy.

    Science.gov (United States)

    Masullo, Milena; Montoro, Paola; Mari, Angela; Pizza, Cosimo; Piacente, Sonia

    2015-09-10

    During last decades an increasing number of herbal products specifically targeting women's disorders has appeared in the worldwide marketplace. This growth highlights the need for a critical evaluation of quality, safety and efficacy of these products. Analytical techniques applied to the quality control of the main medicinal plants used for women health (relief of menopause and menstrual related symptoms) have been reviewed. Thanks to the innovation in analytical technology, identification and detection of secondary metabolites dramatically improved. In particular, hyphenated techniques have proved to be the most suitable for the rapid identification of compounds in plant matrix. Moreover, taking into account that differences in sample quality are not only found in the main compounds or in the chemical markers but also in the low-concentration compounds, fingerprint analysis might be a simple way for identification and quality control of herbal products containing a large number of low amounts of unknown compounds. Furthermore in several papers the informations obtained from the analysis of a plant have been processed by statistical elaborations. Medicinal plants here discussed are classified on the basis of the chemical markers used for their quality control. PMID:25863356

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

    International Nuclear Information System (INIS)

    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

  13. 76 FR 76732 - Nominations to the Advisory Committee on Blood Safety and Availability

    Science.gov (United States)

    2011-12-08

    ..., transfusion organ and tissue transplantation, bioethics, and/or related disciplines. Nominations should be... health, ethical, and legal issues related to transfusion and transplantation safety, and (3) the... Public Health Advisor for Blood, Organ and Tissue Safety Policy, Department of Health and Human...

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

    International Nuclear Information System (INIS)

    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.

  15. Blood safety measures and the role of central blood institute in Japan

    Institute of Scientific and Technical Information of China (English)

    Kenji Tadokoro

    2010-01-01

    @@ 1 Japanese Blood Programme Japanese Red Cross Blood Service is the sole conductor of blood service in Japan. It collects 5.3 million volun-tary non-remunerated donations from 127 million popu-lations and distributes 18 million units ( one unit = 200 ml,2 million Liter) blood matching the medical needs.A part of plasma is supplied to the JRCBS fractionation center and other 3 commercial manufacturers for pro-duction of plasma derivatives.

  16. Introduction to Iranian Blood Transfusion Organization and Blood Safety in Iran

    Directory of Open Access Journals (Sweden)

    H Abolghasemi

    2009-03-01

    Full Text Available "nCurrently, in Iran blood transfusion is an integral part of the national health system and blood donation is voluntary and non­remu­nerated and blood and its components may not be a source of profit. In 1974 and following establishment of Iranian Blood Transfusion Organization (IBTO all blood transfusion activities from donor recruitment to production of blood com­po­nents and delivery of blood and blood products were centralized. The activities of IBTO are followed the laws and regu­la­tions of Ministry of Health and criteria of Iran National Regulatory Authority. In order to meet the country's demand in 2007 IBTO collected about 1.7 millions units of blood from the population of 70 millions. In 1979 coincided with the Is­lamic revolution the number of  blood units collected throughout the country were 124,000 units or 3.4 unit per 1000 popu­la­tion whereas after about 30 years this increased to about 25 unit per 1000 population. With improving the pool of vol­un­tary donors, IBTO has been successful in excluding "family replacement" donation since 2007 and reached to 100% volun­tary and nonremunerated blood donation. Currently more than 92% of blood donors in Iran are male and contribution of fe­male in blood donation is less than 8%. Although all donated blood in Iran screened for HBsAg since 1974, screening of blood units for HIV and HCV started since 1989 and 1996, respectively. The frequency of HBV infection in blood do­nors showed a significant decline from 1.79% in 1998 to 0.4% in 2007. The overall frequency of HCV and HIV infection are 0.13% and 0.004% respectively.

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

    International Nuclear Information System (INIS)

    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.

  18. 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.

  19. 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.

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

    OpenAIRE

    Ilinskaya, Anna N; Dobrovolskaia, Marina A.

    2013-01-01

    Nanoparticle interactions with the blood coagulation system can be beneficial or adverse depending on the intended use of a nanomaterial. Nanoparticles can be engineered to be procoagulant or to carry coagulation-initiating factors to treat certain disorders. Likewise, they can be designed to be anticoagulant or to carry anticoagulant drugs to intervene in other pathological conditions in which coagulation is a concern. An overview of the coagulation system was given and a discussion of a des...

  1. 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.

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

    DEFF Research Database (Denmark)

    Kamper-Jørgensen, Mads; Hjalgrim, Henrik; Edgren, Gustaf; Titlestad, Kjell; Ullum, Henrik; Shanwell, Agneta; Reilly, Marie; Melbye, Mads; Nyrén, Olof; Rostgaard, Klaus

    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....

  3. Optoelectronic blood oximetry as a tool of health safety monitoring

    Science.gov (United States)

    Cysewska-Sobusiak, Anna

    2001-08-01

    A metrological approach of some selected problems connected with the significant field of biomedical optics i.e., monitoring of arterial blood oxygenation by use of the tissues as optical media exposed to the controlled light action, has been presented. The subject of the measurements based on utilization of the selection absorption properties of blood is the hemoglobin oxygen saturation. Using optoelectronic sensing allows to convert sophisticated effects of noninvasive light-living tissue interaction to electrical signals which may be convenient to measure. Pulse oximetry which is based upon such a way of sensing and processing, is the recent advance in noninvasive oximetry. The unique advantages of that marvelous diagnostic technique have caused to recommend pulse oximeters as standard equipment in intensive care and other critical situations impending hypoxemia appearance. However, end-users of the pulse oximeters not always are aware of that these devices fall under specific limitations, of both physiological and technical nature. The author of this paper is a metrologist and deals mainly with various interdisciplinary problems of a measurement reliability including the aspects such as uncertainty of an outcome accessible to the user, causes affecting sensitivity, resolution and repeatability of processing function, and response time and stability of results. Referring to the subject discussed herein, and taking into account some open questions, the author's contribution is her own experience in modeling as well as in in vivo measuring of transilluminated living objects. A proposed novel use of the known pulse oximetry concept may be considered as complementary results against a general review background of the achievements obtained in oximetry as the state-of-the-art, and furthermore, the developing studies which are still in progress.

  4. 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)

    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

  5. 76 FR 15982 - Nominations to the Advisory Committee on Blood Safety and Availability

    Science.gov (United States)

    2011-03-22

    ... incurred to attend meetings and conduct committee-related business, in accordance with Standard Government..., or socioeconomic status. The Standards of Ethical Conduct for Employees of the Executive Branch are.... James J. Berger, Associate Public Health Advisor for Blood, Organ and Tissue Safety. BILLING CODE...

  6. 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. PMID:25855475

  7. Towards improvement in quality assurance

    International Nuclear Information System (INIS)

    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

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

    Science.gov (United States)

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

    2009-01-01

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

  9. Healthcare Software Assurance

    OpenAIRE

    Cooper, Jason G.; Pauley, Keith A.

    2006-01-01

    Software assurance is a rigorous, lifecycle phase-independent set of activities which ensure completeness, safety, and reliability of software processes and products. This is accomplished by guaranteeing conformance to all requirements, standards, procedures, and regulations. These assurance processes are even more important when coupled with healthcare software systems, embedded software in medical instrumentation, and other healthcare-oriented life-critical systems. The current Food and Dru...

  10. Does a perception of increased blood safety mean increased blood transfusion? An assessment of the risk compensation theory in Canada

    Directory of Open Access Journals (Sweden)

    Wilson Kumanan

    2004-06-01

    Full Text Available Abstract Background The risk compensation theory is a widely used concept in transport economics to analyze driver risk behaviour. This article explores the feasibility of applying the theory in blood transfusion to raise important questions regarding the increased blood safety measures and their possible effects on blood usage (e.g., the appropriateness in transfusion. Further, it presents the findings of a pilot survey of physicians in Canada. Discussion While studies have attempted to define transfusion appropriateness, this article argues that if the risk compensation theory holds true for transfusion practice, physicians may actually be transfusing more. This may increase the possibility of contracting other unknown risks, such as the variant Creutzfeldt-Jakob Disease (vCJD, as well as increasing the risk of non-infectious transfusion risks, such as transfusion reactions. Summary A much larger study involving psychosocial assessment of physician decision making process to fully assess physician behaviour within the context of risk compensation theory and transfusion practice in Canada is needed to further explore this area.

  11. 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.)

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

    Science.gov (United States)

    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 pericardial flushing (CPPF) with an irrigation solution may reduce blood loss by preventing the accumulation of clots. In this pilot study, the safety and feasibility of CPPF were evaluated and the effect on blood loss and other related complications was investigated. Methods Between November 2011 and April 2012 twenty-one adult patients undergoing surgery for congenital heart disease (CHD) received CPPF from sternal closure up to 12 h postoperative. With an inflow Redivac drain that was inserted through one of the chest tube incision holes, an irrigation solution (NaCl 0.9% at 38 °C) was delivered to the pericardial cavity using a volume controlled flushing system. Safety aspects, feasibility issues and complications were registered. The mean actual blood loss in the CPPF group was compared to the mean of a retrospective group (n = 126). Results CPPF was successfully completed in 20 (95.2%) patients, and no method related complications were observed. Feasibility was good in this experimental setting. Patients receiving CPPF showed a 30% (P = 0.038) decrease in mean actual blood loss 12 h postoperatively. 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. PMID:26501121

  13. Separation Assurance and Collision Avoidance

    Science.gov (United States)

    Lauderdale, Todd

    2010-01-01

    Objective SACA-1: Determine the level of safety provided by tactical separation assurance safety monitoring systems for UAS missions. a) Rationale: Continuous mission-risk monitoring can provide equivalent levels of safety for UAS operations possibly reducing the burden on other safety systems. b) Approach: Utilize and adapt algorithms and approaches developed for the NextGen Airspace Systems Program for UAS applications.

  14. Practical experience with quality assurance and quality control of instrumentation and control systems - the safety assessors view

    International Nuclear Information System (INIS)

    The paper shows up the inital situation (approx. 1974) concerning QA and QC of I and C-Systems of the Austrian Nuclear Power PLant at Zwentendorf. The main problems were the diversity of manufacturers, QA-levels, parameters. Good communication between all involved parts (vendor, utility, safety assessors) turned out to be one of the most important prerequisites for the safety review work. Then it is exposed how the safety review work was done and some highlights are mentioned. (auth.)

  15. Guidance Note on Health Care Worker Safety from HIV and Other Blood Borne Infections

    OpenAIRE

    Gold, Julian; Tomkins, Maggy; Melling, Phillip; Bates, Nicholas

    2004-01-01

    The safety of heath care workers (HCWs) who take care of people with HIV/AIDS and other infectious diseases is of paramount importance. Occupational transmission of blood borne infections is not regarded as a common problem in developed country settings, but this is not the case in resource poor countries where the incidence and impact of such exposures is under-reported and is now becomin...

  16. Quality assurance in design

    International Nuclear Information System (INIS)

    Full text: Safety of the nuclear power plant depends on design, manufacturing, construction, commissioning and operation of plant. To ensure that all the constituent phases are performed as per intent, quality assurance is extremely important. NPCIL has developed a quality assurance programme for all above constituent phases for ensuring safety of public and site personnel. A topical quality assurance document at corporate level gives broad based policy document on quality assurance programme of NPCIL. For design and engineering services, a quality assurance programme has been developed based on ISO 9001 and AERB Code No. SC/QA. To ensure nuclear reactor safety, the design activities are carried out under controlled conditions which include: (i) establishment and maintenance of procedures describing how the design activities are to be carried out, (ii) assignment of design tasks to appropriately qualified and experienced personnel, (iii) compliance with codes, standards and regulatory requirements, (iv) incorporation of customer feedbacks/corrective and preventative actions, (v) compliance with quality plans and procedures., (vi) design control, (vii) proper document and data control, (viii) use of validated soft wares, (ix) review of consultants design, design documents at appropriate stages, (x) preparation, review and approval of designs and design documents by competent persons, (xi) AERB review of safety related design basis reports (DBRs), (xii) periodic internal quality audits for verifying the compliance to QA system, (xiii) periodic external audits by ISO 9001 certifying agency and NPCIL QA directorate, (xiv) Nonconformance control

  17. Dried blood spots are a useful tool for quality assurance of rapid HIV testing in Kigali, Rwanda.

    OpenAIRE

    Chaillet, P; Zachariah, R.; Harries, K; Rusanganwa, E; Harries, A. D.

    2009-01-01

    A study was conducted in two primary health facilities in Kigali, Rwanda, to determine whether dried blood spots (DBS) used for quality control of HIV testing would give comparable results with serum after being stored for a period of 14 days and 30 days at ambient temperature. DBS and serum specimens were collected from patients undergoing HIV testing. ELISA performed on serum at baseline (gold standard) was compared with DBS results. The study included a total of 491 patients, comprising 92...

  18. 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)

    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

  19. 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.

  20. 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)

    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

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

    Science.gov (United States)

    Loureiro, Paula; de Almeida-Neto, Cesar; Proietti, Anna Bárbara Carneiro; Capuani, Ligia; Gonçalez, Thelma Terezinha; de Oliveira, Claudia Di Lorenzo; Leão, Silvana Carneiro; Lopes, Maria Inês; Sampaio, Divaldo; Patavino, Giuseppina Maria; Ferreira, João Eduardo; Blatyta, Paula Fraiman; Lopes, Maria Esther Duarte; Mendrone-Junior, Alfredo; Salles, Nanci Alves; King, Melissa; Murphy, Edward; Busch, Michael; Custer, Brian; Sabino, Ester Cerdeira

    2014-03-01

    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. PMID:24790542

  2. 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.

  3. Quality-Assurance Program Plan

    International Nuclear Information System (INIS)

    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

  4. Summary report of the Department of Energy, Division of Operational and Environmental Safety: Quality Assurance Programs 9 through 12

    International Nuclear Information System (INIS)

    Analaytical 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 Measurement 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 34 laboratories. EML performed multiple analyses on the samples, however, the results are considered intercomparisons, not standards. The program is summarized, and data for Quality Assessment Programs (QAP) 9 through 12 are evaluated

  5. 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.

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

    International Nuclear Information System (INIS)

    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

  7. Safety of predeposit autologous blood donation in the third trimester of pregnancy.

    Science.gov (United States)

    Lindenbaum, C R; Schwartz, I R; Chhibber, G; Teplick, F B; Cohen, A W

    1990-05-01

    The option of predeposit autologous blood donation (PABD) before elective surgery has been gaining popularity as a means of eliminating the transmission of the acquired immune deficiency syndrome and hepatitis. It also prevents potential antigen sensitization and transfusion reactions. The use of PABD in pregnant women has been described, but its safety for both mother and fetus, especially in the first and third trimester, has not been established. After studying 16 third-trimester pregnant women with antenatal surveillance techniques and continuous fetal monitoring, we concluded that PABD is a safe procedure for both mother and fetus. PMID:2352248

  8. Acute effects of electromagnetic stimulation of the brain on cortical activity, cortical blood flow, blood pressure and heart rate in the cat: an evaluation of safety.

    OpenAIRE

    Eyre, J A; Flecknell, P. A.; Kenyon, B R; Koh, T H; Miller, S.

    1990-01-01

    The influence of repeated high intensity electromagnetic stimulation of the brain on cortical activity, cortical blood flow, blood pressure and heart rate has been investigated in the cat, to evaluate the safety of the method. The observations have been made in preparations under propofol anaesthesia before, during and after periods of anoxia. Electromagnetic stimulation of the brain evoked activity in descending motor pathways and was recorded by activity in the median nerve and by muscle tw...

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

    International Nuclear Information System (INIS)

    An overview of the Finnish national research programme on the Nuclear Power Plant Structural Safety, being carried out from 1990 to 1995, 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). 17 refs, 15 figs, 1 tab

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1988-02-01

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

  11. 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)

    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

  12. Experiment Safety Assurance Package for Mixed Oxide Fuel Irradiation in an Average Power Position (I-24) in the Advanced Test Reactor

    Energy Technology Data Exchange (ETDEWEB)

    J. M . Ryskamp; R. C. Howard; R. C. Pedersen; S. T. Khericha

    1998-10-01

    The Fissile Material Disposition Program Light Water Reactor Mixed Oxide Fuel Irradiation Test Project Plan details a series of test irradiations designed to investigate the use of weapons-grade plutonium in MOX fuel for light water reactors (LWR) (Cowell 1996a, Cowell 1997a, Thoms 1997a). Commercial MOX fuel has been successfully used in overseas reactors for many years; however, weapons-derived test fuel contains small amounts of gallium (about 2 parts per million). A concern exists that the gallium may migrate out of the fuel and into the clad, inducing embrittlement. For preliminary out-of-pile experiments, Wilson (1997) states that intermetallic compound formation is the principal interaction mechanism between zircaloy cladding and gallium. This interaction is very limited by the low mass of gallium, so problems are not expected with the zircaloy cladding, but an in-pile experiment is needed to confirm the out-of-pile experiments. Ryskamp (1998) provides an overview of this experiment and its documentation. The purpose of this Experiment Safety Assurance Package (ESAP) is to demonstrate the safe irradiation and handling of the mixed uranium and plutonium oxide (MOX) Fuel Average Power Test (APT) experiment as required by Advanced Test Reactor (ATR) Technical Safety Requirement (TSR) 3.9.1 (LMITCO 1998). This ESAP addresses the specific operation of the MOX Fuel APT experiment with respect to the operating envelope for irradiation established by the Upgraded Final Safety Analysis Report (UFSAR) Lockheed Martin Idaho Technologies Company (LMITCO 1997a). Experiment handling activities are discussed herein.

  13. The use of software quality assurance techniques in the validation of results in nuclear thermal-hydraulic safety research

    International Nuclear Information System (INIS)

    The Nuclear Engineering Department at Israel Electric Company has been engaged for a number of years in a joint research agreement with the Technion Nuclear Reactor Research Group on various thermal-hydraulic aspects of reactor design and safety. Besides developing their own analytical models, the researchers rely heavily on the RELAPS computer code in their analyses. The RELAPS series are general purpose, thermal-hydraulic system codes, used to simulate system response (such as the RCS) to transients and accidents. They are based on solving the equations of conservation of mass, energy and momentum within the system being modeled, where the model is a series of control volumes connected by junctions. The equations are solved simultaneously in each volume and junction using a finite difference numerical scheme. As an example, a recent report refers to containment response to a large LOCA in an AP600-like advanced rector. This work has been performed using RELAPS/Mod2. Accidents like LOCA represent design base events necessary to verify the adequacy of the emergency core cooling system, the passive containment system and other safety systems. The validation of simulation results is therefore important to the IEC staff responsible for monitoring the research. (author); 3 refs

  14. 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. PMID:19894488

  15. 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. PMID:23636093

  16. 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...

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

    International Nuclear Information System (INIS)

    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.)

  18. Nova laser assurance-management system

    International Nuclear Information System (INIS)

    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

  19. 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

  20. The blood pressure-lowering effect and safety of chlorogenic acid from green coffee bean extract in essential hypertension.

    Science.gov (United States)

    Watanabe, Takuya; Arai, Yoichi; Mitsui, Yuki; Kusaura, Tatsuya; Okawa, Wataru; Kajihara, Yasushi; Saito, Ikuo

    2006-07-01

    Chlorogenic acids (CGA) in green coffee bean extract (GCE) reduce blood pressure in spontaneously hypertensive rats and humans. The authors examined the blood pressure-lowering effect and safety of CGA in patients with mild hypertension through a placebo-controlled, randomized clinical trial. Subjects (n = 28) were randomized to receive treatment with CGA (140 mg/day) from GCE or placebo. Blood pressure, pulse rate, body mass index, routine blood test, hematochemistry, urinalysis, and subjective symptoms were recorded throughout the study. In the CGA group, but not the placebo group, blood pressure (systolic and diastolic) decreased significantly during the ingestion period. There was no difference in body mass index and pulse rate between groups, nor were there any apparent side effects. Thus, CGA from GCE is effective in decreasing blood pressure and safe for patients with mild hypertension. PMID:16820341

  1. Quality assurance in nuclear power plant

    International Nuclear Information System (INIS)

    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.)

  2. Financial assurances

    International Nuclear Information System (INIS)

    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

  3. Flow assurance

    Energy Technology Data Exchange (ETDEWEB)

    Mullins, O.C.; Dong, C. [Schlumberger-Doll Research Center, Cambridge, MA (United States); Elshahawi, H. [Shell Exploration and Production Company, The Hague (Netherlands)

    2008-07-01

    This study emphasized the need for considering flow assurance for producing oil and gas, particularly in high cost areas such as deepwater. Phase behaviour studies, sticking propensities, and interfacial interactions have been investigated in many laboratory studies using asphaltenes, wax, hydrates, organic and inorganic scale, and even diamondoids. However, the spatial variation of reservoir fluids has received little attention, despite the fact that it is one of the most important factors affecting flow assurance. This issue was difficult to address in a systematic way in the past because of cost constraints. Today, reservoir fluid variation and flow assurance can be considered at the outset of a project given the technological advances in downhole fluid analysis. This study described the origins of reservoir fluid compositional variations and the controversies surrounding them. It also described the indispensable chemical analytical technology. The impact of these reservoir fluid compositional variations on flow assurance considerations was also discussed. A methodology that accounts for these variations at the outset in flow assurance evaluation was also presented.

  4. Introduction to quality assurance

    International Nuclear Information System (INIS)

    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.)

  5. Quality assurance within regulatory bodies

    International Nuclear Information System (INIS)

    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

  6. Quality assurance records system

    International Nuclear Information System (INIS)

    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

  7. 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.

  8. Prevalence of p24 antigen among a cohort of HIV antibody negative blood donors in Sokoto, North Western Nigeria - the question of safety of blood transfusion in Nigeria

    Science.gov (United States)

    Osaro, Erhabor; Mohammed, Ndakotsu; Zama, Isaac; Yakubu, Abdulrahaman; Dorcas, Ikhuenbor; Festus, Aghedo; Kwaifa, Ibrahim; Sani, Ibrahim

    2014-01-01

    Introduction Blood transfusions remain a substantial source of HIV in SSA particularly among children and pregnant women. Aims and objectives: This aim of this retrospective study was to investigate the prevalence of p24 antigen among HIV antibody seronegative blood donors in Sokoto, North West Nigeria. Methods A total of 15,061 HIV antibody negative blood donors with mean age and age range (29.2 ± 8.18 and 18-50 years) were screened for p24 antigen between January 2010 to July 2013 using the Diapro Diagnostic immunoassay kit for P24 antigen (King Hawk Pharmaceuticals Beijing China). Results The overall prevalence of p24 antigen among the HIV antibody negative donors sample was 5.84%. The yearly prevalence was 9.79, 8.12, 2.7 and 2.84% respectively in 2010, 2011, 2012 and 2013. Of the total number of blood donor tested, 14,968 (99.38%) were males while 93 (0.62%) were females. The prevalence of P24 antigen was significantly higher among male blood donors 873 (5.8%) compared to females 7(0.05%), (p= 0.001). P24 positivity was significantly higher among blood group O blood donors compared to A, B and AB donors (494 (3.29%) compared to 184 (1.89%), 196 (1.30%) and 6 (0.04%)) respectively, p = 0.001). The prevalence of P24 antigen was significantly higher among Rhesus positive blood donors compared to Rhesus negative (807 (5.36%) versus 73 (0.48%), p =0.001). Conclusion Blood transfusion in Nigeria is associated with increased risk of HIV transmission. There is the urgent need to optimize the screening of blood donors in Nigeria by the inclusion of p24 antigen testing into the blood donor screening menu. The Nigerian government urgently need to adopt the WHO blood safety strategies to reduce the risk of transmission of HIV through blood transfusion. PMID:25419301

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

    OpenAIRE

    Sadhana Mangwana

    2015-01-01

    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 pos...

  10. Quality assurance in radiotherapy

    International Nuclear Information System (INIS)

    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

  11. 10 CFR 830.121 - Quality Assurance Program (QAP).

    Science.gov (United States)

    2010-01-01

    ...) Integrate the quality assurance criteria with the Safety Management System, or describe how the quality assurance criteria apply to the Safety Management System. (3) Use voluntary consensus standards in its... 10 Energy 4 2010-01-01 2010-01-01 false Quality Assurance Program (QAP). 830.121 Section...

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

    Directory of Open Access Journals (Sweden)

    Rada M. Grubovic

    2014-09-01

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

  13. Current Probiotics—Safety Assured?

    OpenAIRE

    Salminen, Seppo; Wright, Atte von

    2011-01-01

    Traditionally probiotics are defined as viable microorganisms (bacteria or yeasts) that have a beneficial effect on the health of the host. Probiotics are used in fermented dairy products, but also in other foods, clinical foods and pharmaceutical preparations and they are also increasingly used as added functional ingredients in non-fermented foods. The selection of new probiotic organisms targets on new strains and even genera that are more beneficial or specific. When totally novel microbe...

  14. The variant Creutzfeldt-Jakob Disease: Risk, uncertainty or safety in the use of blood and blood derivatives?

    Science.gov (United States)

    Liras, Antonio

    2008-01-01

    It has been long since French physician Jean-Baptiste Denys carried out the first successful blood transfusion to a human being. Using bird feathers as canules, sheep blood was transfused to a young man. The patient died soon after Denys' treatment and Denys was accused of murder. In the XXI century, known as the biotechnology century, we face new challenges in Medicine. New emerging and reemerging diseases, such as Creutzfeldt-Jakob disease (CJD) or "mad cow disease" and its human variant (vCJD), challenge the biosafety aspects of a widely extended and extremely useful technique, that is, the perfusion of blood, of its derived components and of other pharmacological products obtained from plasma. To face these new challenges we need innovative prevention strategies. PMID:18573217

  15. Quality assurance

    International Nuclear Information System (INIS)

    Quality checks are essential to assure production of high quality plants and to have end-users confidence. Quality standards require the establishment of suitable tests to maintain quality control. The choice of explant source, freedom of the donor plant from viruses, disease causing fungi, bacteria, viroids, phytoplasmas, vigour and conformity of the variety, and elimination of somaclonal variants are critical for maintaining plant quality. Variety identification by proper labeling at all stages is essential to ensure varietal identity. (author)

  16. The variant Creutzfeldt-Jakob Disease: Risk, uncertainty or safety in the use of blood and blood derivatives?

    OpenAIRE

    Liras, Antonio

    2008-01-01

    It has been long since French physician Jean-Baptiste Denys carried out the first successful blood transfusion to a human being. Using bird feathers as canules, sheep blood was transfused to a young man. The patient died soon after Denys' treatment and Denys was accused of murder. In the XXI century, known as the biotechnology century, we face new challenges in Medicine. New emerging and reemerging diseases, such as Creutzfeldt-Jakob disease (CJD) or "mad cow disease" and its human variant (v...

  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)

    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. Blood plasma fractionaing and the safety against viruses; Kessho bunkaku to uirusu anzensei

    Energy Technology Data Exchange (ETDEWEB)

    Tomono, T.

    1997-05-05

    This paper describes the outline of a typical method of fractionating blood plasma for blood plasma fractional products, and introduces various kinds of operation contributing to the study of measures against viruses. The main fractional products include human blood serum albumin (Alb), human immunoglobulin (IgG) and a blood coagulation factor products. Although blood plasma can be used for the first two product, fresh freezed blood plasma is needed for the coagulation factor products. The blood plasma fractionating methods include methods utilizing the solubility difference of protein, methods, such as chromatography in which the interaction between blood plasma and protein is utilized, and methods utilizing a physical field. The virus inactivation methods include heat treatment methods, treatment methods using an organic solvent and a surfactant, and photochemical inactivation methods, by ultraviolet ray irradiation. The virus removing methods include the Cone fractionating method, methods of removing viruses by chromatography, and membrane filtration removing methods. 12 refs., 5 figs., 3 tabs.

  19. Patient Safety with Blood Products Administration Using Wireless and Bar-Code Technology

    OpenAIRE

    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 scanne...

  20. Quality assurance

    International Nuclear Information System (INIS)

    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

  1. Quality assurance during site construction

    International Nuclear Information System (INIS)

    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)

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

    OpenAIRE

    Lee Young-Ho; Choi Kyung; Moon Jin; Jun Hyun-Joo; Kang Hye-Ryeong; Oh Se-In; Kim Hyung; Um Jang; Kim Mi; Choi Yun; Lee Young-Jun; Kim Hee-Jin; Lee Jong-Hwa; Son Su; Choi Soo-Jin

    2012-01-01

    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 effic...

  3. Quality assurance in the ambulatory care setting.

    Science.gov (United States)

    Tyler, R D

    1989-01-01

    One of the most utilitarian developments in the field of quality assurance in health care has been the introduction of industrial concepts of quality management. These concepts, coupled with buyer demand for accountability, are bringing new perspectives to health care quality assurance. These perspectives provide a new view of quality assurance as a major responsibility and strategic opportunity for management; a competitive and marketable commodity; and a method of improving safety, effectiveness, and satisfaction with medical care. PMID:10313405

  4. Quality assurance program

    International Nuclear Information System (INIS)

    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

  5. 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

    2016-02-01

    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

  6. Grading of quality assurance requirements

    International Nuclear Information System (INIS)

    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

  7. 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...

  8. 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...

  9. 30 CFR 14.8 - Quality assurance.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality assurance. 14.8 Section 14.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... Quality assurance. Applicants granted an approval or an extension of approval under this Part must: (a)...

  10. 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.

  11. Healthy Family 2009: Assuring Healthy Aging

    Science.gov (United States)

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

  12. Design quality assurance for nuclear power plants

    International Nuclear Information System (INIS)

    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

  13. The effectiveness and safety of L-amlodipine besylate for blood pressure control in patients with mild to moderate essential hypertension

    Institute of Scientific and Technical Information of China (English)

    贾坦

    2013-01-01

    Objective To evaluate the effectiveness and safety of L-amlodipine besylate for blood pressure control in patients with mild to moderate essential hypertension.Methods A total of 1051 mild to moderate essential

  14. Concepts of nuclear quality assurance

    International Nuclear Information System (INIS)

    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)

  15. Blood gas and patient safety: considerations based on experience developed in accordance with the Risk Management perspective.

    Science.gov (United States)

    Rambaldi, Marco; Baranzoni, Mariateresa; Coppolecchia, Pasquale; Moschello, Jennifer N; Novaco, Francesca

    2007-01-01

    It is the responsibility of health organizations to guarantee a high level of healthcare by using adequate methodologies and instruments, creating secure conditions for treatment, and preventing adverse events due to human or system errors. It is necessary to introduce Risk Management programs, and in particular to promote Clinical Risk Management, one of the constituent elements of Clinical Governance, to assure the delivery of high-quality performance and services. In the point-of-care testing (POCT) context, using an analysis of our experiences, we discuss the entire analytical process, including acquisition and usage, while focusing on blood gas analyzers. Our experience confirms that within a Clinical Governance framework, it is necessary to apply, even when choosing instruments, a systematic vision that is not limited to analytical validation, but also includes an in-depth analysis of the impact in a specific context. Assessment of the correlated risks, independent of the analytical methodology used, is indispensable in a clinical environment to identify the most suitable approach for such risks. A study of the latent factors can be proactively performed to identify (and stimulate) what the pre-organizational environment (producer companies) can offer in terms of product orientation to effectively reduce correlated risk during use. Among the different options for possible treatment of risk, one involves the transfer of the assumption of risk to third parties (e.g., maintenance and quality controls). Transferring the responsibility for control operations to the operator of the instrument, which follows the quality controls with total autonomy, is equivalent to transferring the correlated risk for the clinician (in the POCT case) to the producer, who becomes the guarantor. In practice this is equivalent to a specific assurance stipulation with zero cost. PMID:17579531

  16. Risk-informed graded quality assurance

    International Nuclear Information System (INIS)

    The grading of quality assurance (QA) controls at nuclear power plant aims at assuring an acceptable safety level but also at allocating QA resources cost-effectively. Historically, QA requirements stem from the safety classification of the systems, structures and components based on deterministic safety criteria. Risk-informed approaches applying the probabilistic safety assessment (PSA) are considered as one solution to rationalise and potentially relax the QA system. In this paper, risk-based conditions are formulated for the assignment of QA grades. The risk-based formulation is a reference model to explore possibilities, requirements and obstacles of this application of PSA. (orig.)

  17. Westinghouse Water Reactor Divisions quality assurance plan

    International Nuclear Information System (INIS)

    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

  18. Graded quality assurance in procurement

    International Nuclear Information System (INIS)

    The Code of Federal Regulations, Part 50, Appendix B, requires every applicant for an operating license to include in its final safety analysis report information pertaining to the managerial and administrative controls to be used to ensure safe operation. This appendix establishes quality assurance requirements for the design, construction, and operation of those structures, systems, and components (SSC) that perform safety-related functions. The activities affecting safety-related SSC functions include designing, purchasing, fabricating, and so forth, Title 10 CFR 50.65 established requirements to ensure that the maintenance activities conducted by licensees are effective. This is also known as the maintenance rule

  19. Quality assurance considerations in nuclear waste management

    International Nuclear Information System (INIS)

    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

  20. 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.

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

    OpenAIRE

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

    2008-01-01

    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 ...

  2. Individual donor-nucleic acid testing for human immunodeficiency virus-1, hepatitis C virus and hepatitis B virus and its role in blood safety

    OpenAIRE

    Rajesh Kumar; Sonia Gupta; Amarjit Kaur; Manvi Gupta

    2015-01-01

    Background: Transfusion-transmitted infections (TTIs) are one of the biggest threats to blood transfusion safety. Nucleic acid testing (NAT) in blood donor screening has been implemented in many countries to reduce the risk of TTIs. NAT shortens this window period, thereby offering blood centers a much higher sensitivity for detecting viral infections. Aims: The objective was to assess the role of individual donor-NAT (ID-NAT) for human immunodeficiency virus-1 (HIV-1), hepatitis C virus (HCV...

  3. 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

  4. 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...

  5. 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.

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

    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.

  7. 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...

  8. Safety

    International Nuclear Information System (INIS)

    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.)

  9. 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. PMID:1286566

  10. Introduction to quality assurance

    International Nuclear Information System (INIS)

    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.)

  11. Safety evaluation of daidzein in laying hens: part I. Effects on laying performance, clinical blood parameters, and organs development.

    Science.gov (United States)

    Shi, S R; Gu, H; Chang, L L; Wang, Z Y; Tong, H B; Zou, J M

    2013-05-01

    Daidzein, an estrogen-like product, becomes increasingly popular as a dietary supplement, particularly for postpeak-estrus animals seeking a safe natural alternative to play a role of estrogen. However, there is little available safety data of it for raisers and consumers. A subchronic laying hen safety study was conducted to examine if the high-dose daidzein could affect the safety of hens selves, including laying performance, clinical blood parameters and organs development. Seven hundred and sixty-eight 56-week-old Hyline Brown were randomly assigned to 4 groups with 8 replicates of 24 birds each and 3weeks later fed diets supplemented with 0, 10, 50 and 100mg of daidzein/kg for 12weeks. The mortality was significantly decreased (P0.05). In clinical chemistry parameters, total protein, total cholesterol, calcium and phosphorus were significantly affected by dietary daidzein supplement (P<0.05). The no observed adverse effect level (NOAEL) is considered to be 50mg/kg. PMID:23391597

  12. Quality management and quality assurance

    International Nuclear Information System (INIS)

    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.)

  13. Software Assurance Using Structured Assurance Case Models

    OpenAIRE

    Rhodes, Thomas; Boland, Frederick; Fong, Elizabeth; Kass, Michael

    2010-01-01

    Software assurance is an important part of the software development process to reduce risks and ensure that the software is dependable and trustworthy. Software defects and weaknesses can often lead to software errors and failures and to exploitation by malicious users. Testing, certification and accreditation have been traditionally used in the software assurance process to attempt to improve software trustworthiness. In this paper, we examine a methodology known as a structured assurance mo...

  14. Quality standards, safety and efficacy of blood-derived serum eye drops: A review.

    Science.gov (United States)

    van der Meer, Pieter F; Seghatchian, Jerard; Marks, Denese C

    2016-02-01

    Serum eye drops (SEDs) are being used increasingly to treat dry eye syndrome and persistent corneal epithelial defects, and are usually prescribed when conventional treatments fail. SEDs are commonly sourced from the patient's own blood via an autologous collection. Although SEDs are clearly beneficial, they are not available for those patients that cannot donate sufficient blood, and some centres are moving to allogeneic SEDs. Many studies have reported that both allogeneic and autologous SEDs are effective. However, few large randomised controlled trials have been conducted to date, and clinical evidence is therefore limited to smaller studies. Alternatives to serum are also being explored, such as platelet lysate and products made from platelet rich plasma, as they are a rich source of growth factors. This article reviews how some centres are approaching allogeneic collections for SEDs, and alternatives to serum that are currently being explored. PMID:26847866

  15. Observing the Safety Precautions Against Blood-Borne Infections by Delivery Agents in Therapeutic and Training Hospitals of Tabriz in 2011-2012

    Directory of Open Access Journals (Sweden)

    Soheila Bani

    2014-01-01

    Full Text Available Objectives: Blood transferred disease is one of the great difficulties for human and it is counted as one of the serious problems of public health. Although health care is valuable, it has some risks such as contacting with various pathogens, especially blood transferred pathogens, so the aim of this study is to observe the safety precautions against blood-borne infections by delivery agents in therapeutic and training hospitals of Tabriz in 2012. Materials and Methods: This study is a descriptive research and all of the participants were the childbirth agents in 3 hospital of Tabriz (Alzahra , Taleghani , 29 Bahman. All of sample size was 100 persons. After obtaining informed consent, the questionnaires which contain demographic information and 24 statements that they were related to observance of safety points against blood transferred infections in childbirth rooms were given to participants to complete. The data were analyzed with SPSS software (Ver. 13. Results: Results showed that the rate of total observance of safety precautions against blood transmitted diseases was good in 54% of delivery agents and in 46% of them was average. Conclusion: Observing safety precautions against blood transmitted diseases needs motivation, effective education and necessary, that all of them should be in priority of health care planning by relevant authorities to reduce contaminated individuals and the costs of their treatment.

  16. Xenotropic Murine Leukemia Virus-Related Virus (XMRV) and the Safety of the Blood Supply.

    Science.gov (United States)

    Johnson, Andrew D; Cohn, Claudia S

    2016-10-01

    In 2006, a new virus, xenotropic murine leukemia virus-related virus (XMRV), was discovered in a cohort of U.S. men with prostate cancer. Soon after this initial finding, XMRV was also detected in samples from patients with chronic fatigue syndrome (CFS). The blood community, which is highly sensitive to the threat of emerging infectious diseases since the HIV/AIDS crisis, recommended indefinite deferral of all blood donors with a history of CFS. As XMRV research progressed, conflicting results emerged regarding the importance of this virus in the pathophysiology of prostate cancer and/or CFS. Molecular biologists traced the development of XMRV to a recombination event in a laboratory mouse that likely occurred circa 1993. The virus was propagated via cell lines derived from a tumor present in this mouse and spread through contamination of laboratory samples. Well-controlled experiments showed that detection of XMRV was due to contaminated samples and was not a marker of or a causal factor in prostate cancer or CFS. This paper traces the development of XMRV in the prostate and CFS scientific communities and explores the effect it had on the blood community. PMID:27358491

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

    Science.gov (United States)

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

    2012-10-01

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

  18. [Jean-Jacques Lefrère: A miscarried ambition for blood safety in francophone Africa].

    Science.gov (United States)

    Tayou Tagny, C; Laperche, S; Murphy, E

    2016-02-01

    The announcement of the death of Professor Jean-Jacques Lefrère caused considerable emotion and surprise within the francophone Africa blood transfusion research network. The group was created in 2007 in Paris. Each member that works within this group wanted to pay their last respects through dedicated publication for a brilliant researcher and writer. The tribute describes the creation of the group, its goals, its operations, its achievements and the prospects of its activities while emphasizing the essential role that Professor Lefrère played within the group. PMID:26762688

  19. 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 inclu

  20. The Safety of Autologous Peripheral Blood Stem Cell Transplantation by Intracoronory Infusion in Patients with Acute Myocardial Infarction

    Institute of Scientific and Technical Information of China (English)

    Zhang Ming; Li Zhanquan; Cui Lijie; Jin Yuanzhe; Yuan Long; Zhang Weiwei; Zhao Hongyuan

    2005-01-01

    Objectives Bone-marrow stem-cell transplantation has been shown to improve cardiac function in patients with acute myocardial infarction (AMI), but the safety of intracoronory infusion of autologous peripheral blood stem-cell (PBSCs) in patients with AMI is unknown. For this reason, we observe the feasibility and safety of PBSCs transplantation by intracoronory infusion in such patients. Methods 41 patients with AMI were allocated to receive granulocyte colony-stimulating factor (GCSF: Filgrastim, 300μg) with the dose of 300μg~600μg/day to mobilize the stem cell, and the duration of applying G-CSF was 5 days. On the sixth day, PBSCs were separated by Baxter CS 3000 blood cel 1 separator into suspend liquid 57 ml. Then the suspend liquid was infused into the infarct related artery (IRA)by occluding the over the wire balloon and infusing artery through balloon center lumen. In the process of the intracoronary infusion of PBSCs, the complications should be observed, which were arrhythmias including of bradycardia, sinus arrest or atrial ventricular block,premature ve. ntricular beats , ven~icular tachycardia,ventricular fibrillation; and hypotention, etc. Results There were total 10 cases with complications during the intracoronary infusion of PBSCs. The incidence of complications was 24.4% ( 10/41 ), including bradycardia was 2.4 % (1/41), sinus arrest or atrial ventricular block was 4.0% (2/41), ventricular fibrillation was 2.4 %(1/41), hypotentionwas 14.6 % (6/41).Conclusions In patients with AMI, intracoronary infusion of PBSCs is feasible and safe.

  1. Commissioning quality assurance for nuclear power plants

    International Nuclear Information System (INIS)

    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

  2. QUALITY ASSURANCE UPDATE

    Science.gov (United States)

    An overview of the air pollution quality assurance program as implemented by EMSL/RTP is presented. The discussion includes method standardization operations for both ambient air and stationary source measurements, the quality assurance audit program, the ambient air equivalency ...

  3. 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. PMID:24604846

  4. General safety aspects

    International Nuclear Information System (INIS)

    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

  5. 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…

  6. Computer software quality assurance

    International Nuclear Information System (INIS)

    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

  7. New techniques in quality assurance

    International Nuclear Information System (INIS)

    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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1991-10-01

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

  9. 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.

  10. Assurance of quality in the diagnostic X-ray department

    International Nuclear Information System (INIS)

    A handbook has been prepared on the 'Assurance of Quality in the Diagnostic X-ray Department'. Part 1 discusses applied techniques which covers organization and methods, reject analysis, radiation protection, status tests, tolerance limits, practical tests for X-ray equipment and electrical and mechanical safety. Part 2 discusses the systematic approach to quality assurance. Part 3 discusses quality assurance for computed tomography, magnetic resource imaging systems and digital subtraction angiography. (U.K.)

  11. 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...

  12. 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...

  13. Peripheral blood stem cells transplantation in patients with heart failure after myocardial infarction: their efficiency and safety

    Institute of Scientific and Technical Information of China (English)

    Xiang Gu; Houtian Xu; Minghui Li

    2007-01-01

    Objective To compare the efficiency and safety of intracoronary transplantation of peripheral blood stem cells (PBSC) between elderly and younger patients with heart failure after myocardial infarction (MI). Methods Twenty-five patients with heart failure after MI were divided into aged group(≥60 years,n=13) and non-aged group (<60years,n=12) to receive intracoronary PBSC transplantation (PBSCT) following bone marrow cells mobilized by granulocyte colony-stimulating factor (G-CSF). Clinical data including coronary lesion characteristic, left ventricular shape, infarct region area and cardiac function, as well as adverse side effects between the two groups were compared. Left ventricular function was evaluated before and 6 months after the treatment by single photon emission computed tomography (SPECT). Results At 6 months, the left ventricular ejection fraction (LVEF) and 6 minute walk test (6MWT)distance increased, while the left ventricular diastolic diameter (LVDd) decreased significantly in both groups. There were no significant difference between the two groups in absolute change in the cardiac function parameters. Conclusions The present study demonstrated that autologous intracoronary PBSCT might be safe and feasible for both old and younger patients with heart failure after MI and left ventricular function is significantly improved.

  14. 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.

  15. [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. PMID:15332359

  16. Hanford Tanks Initiative quality assurance implementation plan

    International Nuclear Information System (INIS)

    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

  17. Quality assurance in fabrication of boilers and pressure vessels

    International Nuclear Information System (INIS)

    Quality assurance for safety and reliability of boilers and pressure vessels is a systematic approach involving various stages right from material identification to final stages of testing, transportation and storage before commissioning. This paper brings out various quality . Assurance aspects to be implemented by manufacturers of boilers and pressure vessels. 1 fig

  18. 10 CFR 830.122 - Quality assurance criteria.

    Science.gov (United States)

    2010-01-01

    ... DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.122 Quality assurance...) Criterion 3—Management/Quality Improvement. (1) Establish and implement processes to detect and prevent... correcting the problem. (4) Review item characteristics, process implementation, and other...

  19. Establishing of Quality Assurance System of VATESI

    International Nuclear Information System (INIS)

    Decision to establish VATESI quality assurance system (QAS) was made in October 2000. QAS aims and procedures to be improved are listed. Description of the plan how QAS will be established is presented. VATESI counts on Finland's assistance in training on document management and developing safety regulations

  20. Establishing Quality Assurance System of VATESI

    International Nuclear Information System (INIS)

    Decision to establish VATESI quality assurance system (QAS) was made in October 2000. Experts representing Licensing Assistance Project countries have been providing support in establishing the QAS, especially specialists from France, Sweden. QAS aims and procedures to be improved are listed. In 2002 two procedures were drafted: Inspections and enforcement measures and Safety assessment

  1. Metrology assurance of atomic energy

    International Nuclear Information System (INIS)

    The metrology assurance of the Kozloduy NPP is at a satisfactory level. The assessment is carried out following the requirements of both the authorized bodies and the recent acting documents. Considering the future development of the nuclear energy and the new demands towards nuclear safety, the metrology assurance of atomic energy needs some improvement. A thorough set of measures should be developed as: preparing of standard documentation, personnel education, purchase of new highly accurate appliances, and providing conditions for the fulfillment of some qualified metrology activities. This will take an extremely difficult and long period of time with respect to the country circumstances, the energy generation and the variety of reorganizations in all management spheres. Prerequisite for this are: the metrologist' desire to fulfill the above tasks, the NPP administration concern and actions to solve the metrology assurance problems, the understanding from the authorized bodies and other scientific institutions and the assistance on the part of some western countries, mainly France. A leading part in fulfilling this problems should be played by the NEC-SA - Kozloduy NPP. (author)

  2. Fluor Pioneer Inc. Quality Assurance Program. Topical report FPI-1

    International Nuclear Information System (INIS)

    A quality assurance program is presented which applies to those design and procurement activities involving safety-related structures, systems, and components of nuclear power plants within the Fluor Pioneer scope of work

  3. High assurance services computing

    CERN Document Server

    2009-01-01

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

  4. Authentication Assurance Levels

    International Nuclear Information System (INIS)

    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.

  5. Quality assurance program

    International Nuclear Information System (INIS)

    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.)

  6. Individual donor-nucleic acid testing for human immunodeficiency virus-1, hepatitis C virus and hepatitis B virus and its role in blood safety

    Directory of Open Access Journals (Sweden)

    Rajesh Kumar

    2015-01-01

    Full Text Available Background: Transfusion-transmitted infections (TTIs are one of the biggest threats to blood transfusion safety. Nucleic acid testing (NAT in blood donor screening has been implemented in many countries to reduce the risk of TTIs. NAT shortens this window period, thereby offering blood centers a much higher sensitivity for detecting viral infections. Aims: The objective was to assess the role of individual donor-NAT (ID-NAT for human immunodeficiency virus-1 (HIV-1, hepatitis C virus (HCV and hepatitis B virus (HBV and its role in blood safety. Materials and Methods: A total of 32978 donations were tested for all three viruses using enzyme-linked immuno-sorbent assay (Vironostika ® HIV Ag-Ab, Hepanostika ® HCV ultra and hepatitis B surface antigen ultra by Biomerieux and ID-NAT using Procleix Ultrio plus ® Assay (Novartis Diagnostic, USA. All initial NAT reactive samples and serology nonreactive were retested in triplicate and NAT discriminatory assay for HIV-1, HCV and HBV were performed. Results: Of the 32978 samples, 43 (0.13% were found to be ID-NAT reactive but seronegative. Out of 43, one for HIV-1, 13 for HCV and 27 for HBV were reactive by discriminatory assays. There were two samples that were reactive for both HCV-HBV and counted as HCV-HBV co-infection NAT yield. The prevalence of these viruses in our sample, tested by ID-NAT is 0.06%, 0.71%, and 0.63% for HIV-1, HCV and HBV respectively. The combined NAT yield among blood donors was 1 in 753. Conclusion: ID-NAT testing for HIV-1, HCV and HBV can tremendously improve the efficacy of screening for protecting blood recipient from TTIs. It enables detection of these viruses that were undetected by serological test and thus helped in providing safe blood to the patients.

  7. Quality assurance plan, Westinghouse Nuclear Energy Systems Divisions

    International Nuclear Information System (INIS)

    The Quality Assurance Plan 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. This document replaces the contents of Chapter 17 Safety Analysis Reports, except for any special or unique requirements. (auth)

  8. 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.

  9. Quality assurance for gamma knives

    International Nuclear Information System (INIS)

    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

  10. Towards Run-time Assurance of Advanced Propulsion Algorithms

    Science.gov (United States)

    Wong, Edmond; Schierman, John D.; Schlapkohl, Thomas; Chicatelli, Amy

    2014-01-01

    This paper covers the motivation and rationale for investigating the application of run-time assurance methods as a potential means of providing safety assurance for advanced propulsion control systems. Certification is becoming increasingly infeasible for such systems using current verification practices. Run-time assurance systems hold the promise of certifying these advanced systems by continuously monitoring the state of the feedback system during operation and reverting to a simpler, certified system if anomalous behavior is detected. The discussion will also cover initial efforts underway to apply a run-time assurance framework to NASA's model-based engine control approach. Preliminary experimental results are presented and discussed.

  11. Efficacy and Safety of Antifibrinolytic Agents in Reducing Perioperative Blood Loss and Transfusion Requirements in Scoliosis Surgery: A Systematic Review and Meta-Analysis

    OpenAIRE

    WANG, Meng; Zheng, Xin-Feng; Jiang, Lei-Sheng

    2015-01-01

    Background Routine use of antifibrinolytic agents in spine surgery is still an issue of debate. Objective To gather scientific evidence for the efficacy and safety of antifibrinolytic agents including aprotinin, tranexamic acid (TXA) and epsilon aminocaproic acid (EACA, traditionally known as Amicar) in reducing perioperative blood loss and transfusion requirements in scoliosis surgery. Methods We conducted a systematic review and meta-analysis for randomized controlled trials (RCTs), retrosp...

  12. Tainted blood

    DEFF Research Database (Denmark)

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

    2015-01-01

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

  13. Quality assurance of radiolabeled proteins, peptides and antisense oligonucleotides

    International Nuclear Information System (INIS)

    Radiopharmaceuticals (RP) labeled with nonmetallic (I-123, C-11, F-18) and metallic radionuclides (Tc-99m, Ga-67, In-111) are used for diagnosis and therapy; they could be classified as blood flow markers, metabolic substrates, receptor ligands, peptide/proteins and antisense oligonucleotide analogs (I-123, In-111). For safety and efficacy of the test using these tracers, quality assurance (QA) of RP (Chemical, radionuclidic, radiochemical impurities, enantiomers, immunoreactivity, sterility, apyrogenicity, cell-viability) is required. This test is more critical for the RP under clinical investigations. FDA allows a maximum permissible limit of 10% of the injected radionuclide as impurity. Quality assurance of RP is carried out by thin-layer, size-exclusion and high pressure liquid chromatography. For therapeutic RP labeled with I-131 (β,γ), Re-186 (β,γ), Re-188 (β), Y-90 (β), Y-90 (β), At-211(α) and Bi-212 (α), etc., the level of chemical alterations/degradations, directly by energetic particles or indirectly by free-radicals, is higher for the α-,β- than γ-emitting RP and chemical alterations are time-dependent processes. Considering the adverse reactions (marrow-suppression), unnecessary radiation due to unbound tracers and impurities, QA of RP should be performed and impurities eliminated before RP administration

  14. Animal Drug Safety FAQs

    Science.gov (United States)

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Animal & Veterinary Home Animal & Veterinary Safety & Health Frequently Asked Questions Animal Drug Safety Frequently Asked Questions Share Tweet Linkedin ...

  15. DOE financial assurance presentation

    International Nuclear Information System (INIS)

    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.'

  16. Repository construction management and quality assurance

    International Nuclear Information System (INIS)

    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

  17. 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)

    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

  18. 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).

  19. 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.

  20. Quality Assurance in Radiotherapy

    Science.gov (United States)

    Mckenzie, Alan

    A common feature of the Radiotherapy Centres where there have been major accidents involving incorrect radiotherapy treatment is that they did not operate good Quality Assurance systems. A Quality Assurance system is sometimes called a Quality Management system, and it is designed to give assurance that quality standards are being met. One of the "spin offs" from operating a Quality Management system is that it reduces the likelihood of a radiotherapy accident. A detailed account of how to set up a quality system in radiotherapy has been given in an ESTRO booklet.2

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

    International Nuclear Information System (INIS)

    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)

  2. Quality assurance for SPECT systems

    International Nuclear Information System (INIS)

    Quality control is crucial to all aspects of nuclear medicine practice, including the measurement of radioactivity, the preparation of radiopharmaceuticals, the use of instrumentation to obtain images, computations to calculate functional parameters, and the interpretation of the results by the physician. It plays an integral part in fulfilling the regulatory requirement for establishing a comprehensive quality assurance programme as described in the International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources. In 1984, the IAEA published IAEA-TECDOC-317, Quality Control of Nuclear Medicine Instruments, which addressed the quality control of radionuclide activity calibrators (also known as dose calibrators), gamma counters, and single and multiprobe counting systems, rectilinear scanners and scintillation cameras. An updated version of IAEA-TECDOC-317 was issued in 1991 as IAEA-TECDOC-602, and this included new chapters on scanner-computer systems and single photon emission computed tomography (SPECT) systems. The rapidly increasing use of SPECT systems during the 1990s prompted the need for a further update of these publications with special emphasis on SPECT systems, planar scintillation cameras, camera-computer systems and whole body scanning systems. Since rectilinear scanners have already been, or will soon be, phased out in Member States, the current publication excludes them completely. Quality assurance and quality control aspects of instrumentation for radioactivity measurements in nuclear medicine are addressed in Technical Reports Series No. 454, Quality Assurance for Radioactivity Measurement in Nuclear Medicine. The current publication is intended to be a resource for medical physicists, technologists and other healthcare professionals who are responsible for ensuring optimal performance of imaging instruments, particularly SPECT systems, in their respective institutions. It is intended for

  3. RAVEN Quality Assurance Activities

    International Nuclear Information System (INIS)

    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.

  4. Quality Assurance Through Reimbursement

    OpenAIRE

    Shaughnessy, Peter W.; Kurowski, Bettina

    1982-01-01

    Quality assurance and reimbursement programs normally function separately in the health care field. This paper reviews objectives and certain conceptual issues associated with each type of program. Its primary intent is to summarize substantive and operational topics which must be addressed if quality of care is to be enhanced through reimbursement. The focus is on methods for integrating quality assurance and reimbursement. The final section presents topics for future research.

  5. 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.

  6. Quality assurance in radiotherapy

    International Nuclear Information System (INIS)

    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)

  7. 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.

  8. Performance assurance program plan

    Energy Technology Data Exchange (ETDEWEB)

    Rogers, B.H.

    1997-11-06

    B and W Protec, Inc. (BWP) is responsible for implementing the Performance Assurance Program for the Project Hanford Management Contract (PHMC) in accordance with DOE Order 470.1, Safeguards and Security Program (DOE 1995a). The Performance Assurance Program applies to safeguards and security (SAS) systems and their essential components (equipment, hardware, administrative procedures, Protective Force personnel, and other personnel) in direct support of Category I and H special nuclear material (SNM) protection. Performance assurance includes several Hanford Site activities that conduct performance, acceptance, operability, effectiveness, and validation tests. These activities encompass areas of training, exercises, quality assurance, conduct of operations, total quality management, self assessment, classified matter protection and control, emergency preparedness, and corrective actions tracking and trending. The objective of the Performance Assurance Program is to capture the critical data of the tests, training, etc., in a cost-effective, manageable program that reflects the overall effectiveness of the program while minimizing operational impacts. To aid in achieving this objective, BWP will coordinate the Performance Assurance Program for Fluor Daniel Hanford, Inc. (FDH) and serve as the central point for data collection.

  9. Quality assurance and protecting the environment

    International Nuclear Information System (INIS)

    The author discusses how the difficulties which inhibit the wider use of nuclear power as an environmentally attractive energy option are attributable in important measure to insufficient attention to quality assurance and related engineering standards. While significant advances have been made in both areas, they have contributed most to systems and components defined as important to safety, where they are mandatory, and less to the Balance of Plant, which has an important influence on reliability. Taking full advantage of the environmental benefits of nuclear power implies bringing the reliability of plants generally up to the levels of the best performers among them. This implies more effective application of quality assurance to the Balance of plant. It also requires that the development of plants of advanced design take advantage of the experience of earlier reactor development programs as regards quality assurance and engineering standards

  10. Challenges in mine safety

    International Nuclear Information System (INIS)

    Some of the key issues discussed are: new technology in mining and its impact on safety, risk assessment and accident prevention, information technology and mine safety, quality assurance and safety, workplace monitoring and occupational health surveys, disaster prevention and management plans, environmental concerns and public acceptance and human resource development

  11. General safety considerations

    International Nuclear Information System (INIS)

    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

  12. A basic study on molecular hydrogen (H2 inhalation in acute cerebral ischemia patients for safety check with physiological parameters and measurement of blood H2 level

    Directory of Open Access Journals (Sweden)

    Ono Hirohisa

    2012-08-01

    Full Text Available Abstract Background In animal experiments, use of molecular hydrogen ( H2 has been regarded as quite safe and effective, showing benefits in multiple pathological conditions such as ischemia-reperfusion injury of the brain, heart, kidney and transplanted tissues, traumatic and surgical injury of the brain and spinal cord, inflammation of intestine and lung , degenerative striatonigral tissue and also in many other situations. However, since cerebral ischemia patients are in old age group, the safety information needs to be confirmed. For the feasibility of H2 treatment in these patients, delivery of H2 by inhalation method needs to be checked for consistency. Methods Hydrogen concentration (HC in the arterial and venous blood was measured by gas chromatography on 3 patients, before, during and after 4% (case 1 and 3% (case2,3 H2 gas inhalation with simultaneous monitoring of physiological parameters. For a consistency study, HC in the venous blood of 10 patients were obtained on multiple occasions at the end of 30-min H2 inhalation treatment. Results The HC gradually reached a plateau level in 20 min after H2 inhalation in the blood, which was equivalent to the level reported by animal experiments. The HC rapidly decreased to 10% of the plateau level in about 6 min and 18 min in arterial and venous blood, respectively after H2 inhalation was discontinued. Physiological parameters on these 3 patients were essentially unchanged by use of hydrogen. The consistency study of 10 patients showed the HC at the end of 30-min inhalation treatment was quite variable but the inconsistency improved with more attention and encouragement. Conclusion H2 inhalation of at least 3% concentration for 30 min delivered enough HC, equivalent to the animal experiment levels, in the blood without compromising the safety. However, the consistency of H2 delivery by inhalation needs to be improved.

  13. Safety strategy

    International Nuclear Information System (INIS)

    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.)

  14. Next Generation CANDU Performance Assurance

    International Nuclear Information System (INIS)

    AECL is developing a next generation CANDU design to meet market requirements for low cost, reliable energy supplies. The primary product development objective is to achieve a capital cost substantially lower than the current nuclear plant costs, such that the next generation plant will be competitive with alternative options for large-scale base-load electricity supply. However, other customer requirements, including safety, low-operating costs and reliable performance, are being addressed as equally important design requirements. The main focus of this paper is to address the development directions that will provide performance assurance. The next generation CANDU is an evolutionary extension of the proven CANDU 6 design. There are eight CANDU 6 units in operation in four countries around the world and further three units are under construction. These units provide a sound basis for projecting highly reliable performance for the next generation CANDU. In addition, the next generation CANDU program includes development and qualification activities that will address the new features and design extensions in the advanced plant. To limit product development risk and to enhance performance assurance, the next generation CANDU design features and performance parameters have been carefully reviewed during the concept development phase and have been deliberately selected so as to be well founded on the existing CANDU knowledge base. Planned research and development activities are required only to provide confirmation of the projected performance within a modest extension of the established database. Necessary qualification tests will be carried out within the time frame of the development program, to establish a proven design prior to the start of a construction project. This development support work coupled with ongoing AECL programs to support and enhance the performance and reliability of the existing CANDU plants will provide sound assurance that the next generation

  15. Irregular antibodies screening before blood transfusion and safety in blood transfusion%输血前不规则抗体筛查与输血安全

    Institute of Scientific and Technical Information of China (English)

    苗伶俐

    2015-01-01

    Objective:To explore the importance of irregular antibodies screening before blood transfusion. Methods:From March 2009 to March 2012,3 215 cases of patients with blood transfusion were selected as treatment group,and irregular antibody was detected before blood transfusion by polybrene method and microcolumn gel test. From January 2009 to February 2009,3 113 cases of patients with blood transfusion were selected as control group,and the incidence of adverse transfusion reaction was counted. Results:The positive rate of treatment group was 0. 40%,and the positive rate of female(0. 60%,10/1 500) was 3. 5 times of male(0. 17%, 3/1 715). Of the entire female positive,maternal positive rate was 1. 14%,8/701,4. 5 times of non-maternal(0. 25%,2/799). Depart-ment of hepatobiliary surgery,general surgery and nephrology have 10 cases of positive(76. 92%,10/13),while other departments have 3 only(23. 08%,3/13). The difference was statistically significant(P<0. 05). There were 29 cases of adverse transfusion reaction in control group(0. 93%),while 3 cases in treatment group(0. 093%). The difference has statistical significance(χ2 =9. 239,P <0. 05). Conclusion:Patients with pregnant history and department of hepatobiliary surgery,general surgery and nephrology are high-risk groups in blood transfusion. With the strict implementation of irregular antibodies screening process,the occurrence rates of blood trans-fusion adverse reactions reduced apparently in clinical blood transfusion.%目的::探讨输血前不规则抗体筛查在输血安全中的重要性。方法:选取我院2009年3月至2012年3月共3215例输血患者为试验组,采用聚凝胺法、微柱凝胶法行输血前不规则抗体筛查。以2006年1月至2009年2月期间我院3113例输血患者为对照组,统计输血反应不良发生率。结果:试验组阳性率0.40%,女性阳性率(0.60%,10/1500)为男性(0.17%,3/1715)的3.5倍;女性阳性患者中,孕产妇阳性率(1.14%,8/701)是非

  16. Review of SKB's Quality Assurance Programme

    International Nuclear Information System (INIS)

    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

  17. Quality assurance and product quality

    International Nuclear Information System (INIS)

    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

  18. Quality assurance of BNCT dosimetry

    International Nuclear Information System (INIS)

    The Phase I clinical trials for boron neutron capture therapy (BNCT) started in May 1999 in Otaniemi, Espoo. For BNCT no uniform international guidance for the quality assurance of dosimetry exists, so far. Because of the complex dose distribution with several different dose components, the international recommendations on conventional radiotherapy dosimetry are not applicable in every part. Therefore, special guidance specifically for BNCT is needed. To obtain such guidelines a European collaboration project has been defined. The aim of the project is a generally accepted Code of Practice for use by all European BNCT centres. This code will introduce the traceability of the dosimetric methods to the international measurement system. It will also ensure the comparability of the results in various BNCT beams and form the basis for the comparison of the treatment results with the conventional radiotherapy or other treatment modalities. The quality assurance of the dosimetry in BNCT in Finland covers each step of the BNCT treatment, which include dose planning imaging, dose planning, boron infusion, boron kinetics, patient positioning, monitoring of the treatment beam, characterising the radiation spectrum, calibration of the beam model and the dosimetric measurements both in patients (in viva measurements) and in various phantoms. The dose planning images are obtained using a MR scanner with MRI sensitive markers and the dose distribution is computed with a dose planning software BNCTRtpe. The program and the treatment beam (DORT) model used have been verified with measurements and validated with MCNP calculations in phantom. Dosimetric intercomparison has been done with the Brookhaven BNCT beam (BMRR). Before every patient irradiation the relationship between the beam monitor pulse rate and neutron fluence rate in the beam is checked by activation measurements. Kinetic models used to estimate the time-behavior of the blood boron concentration have been verified

  19. Vega flow assurance system

    Energy Technology Data Exchange (ETDEWEB)

    Larsen, Marit; Munaweera, Sampath

    2010-07-01

    Vega is a gas condensate field located at the west coast of Norway and developed as a tie-in to the Gjoea platform. Operator is Statoil, production startup is estimated to the end of 2010. Flow assurance challenges are high reservoir pressure and temperature, hydrate and wax control, liquid accumulation and monitoring the well/template production rates. The Vega Flow Assurance System (FAS) is a software that supports monitoring and operation of the field. The FAS is based FlowManagerTM designed for real time systems. This is a flexible tool with its own steady state multiphase- and flow assurance models. Due to the long flowlines lines and the dynamic behavior, the multiphase flow simulator OLGA is also integrated in the system. Vega FAS will be used as: - An online monitoring tool - An offline what-if simulation and validation tool - An advisory control system for well production allocation. (Author)

  20. AVLIS Production Plant Preliminary Quality Assurance Plan and Assessment

    International Nuclear Information System (INIS)

    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

  1. Quality assurance considerations for nuclear power system selection

    International Nuclear Information System (INIS)

    Factors that influence the selection of a nuclear power system, from considerations of quality assurance are discussed. These are categorised as reliability, public safety, technological resources, economics, industrial security, and regulatory framework. The key quality assurance principle to be applied is to establish that the technological basis is understood and used properly. Knowledgeable and capable personnel with experience in the application are needed, and they must have access to appropriate engineering, laboratory and manufacturing facilities. A suitable balance must be maintained between the responsibilities of the seller-supplier and the purchaser-owner to assure an even-handed treatment of the implementation programme. Safety and reliability must be inherent to the regulatory framework. There must be flexibility in the purchaser-owner resources to overcome unanticipated adversity. Given these quality assurance elements, the nuclear system selection process should result in a high probability that the performance objectives will be satisfied. (U.K.)

  2. Influence of quality assurance on company management

    International Nuclear Information System (INIS)

    The implementation of quality assurance programmes affects the management of companies as it imposes certain constraints on their operation and requires a number of additional tasks to be performed. It is difficult to make a qualitative study of these constraints and their effects on cost, lead times and quality, and even more difficult to quantify them. The company must allocate the human and financial resources required to implement the programme. Like other expenditures, these must be properly managed to ensure that they are utilized most effectively. In order to assess the consequences of a quality assurance programme for the management of a company, a clear distinction must be drawn between that which relates to equipment quality (i.e. characteristics and performance) and that which results from the quality assurance of this same equipment. The constraints which quality assurance places on the performance of certain company activities are examined, and an attempt is made to point out the differences with regard to the good management practices of companies skilled in manufacturing quality installations not subject to nuclear safety requirements. The author describes a management method for these complementary tasks aimed at obtaining maximum effectiveness. The review has been limited to design verification, audits, monitoring of manufacturing and installation processes, training and certification of personnel, methods of handling non-conforming items and corrective action to be taken, and, finally, records. A number of examples are given to demonstrate the effectiveness of quality assurance in obtaining the quality of equipment and systems required to ensure the safety of nuclear power facilities

  3. Quality Assurance for All

    Science.gov (United States)

    Cheung, Peter P. T.; Tsui, Cecilia B. S.

    2010-01-01

    For higher education reform, most decision-makers aspire to achieving a higher participation rate and a respectable degree of excellence with diversity at the same time. But very few know exactly how. External quality assurance is a fair basis for differentiation but there can be doubt and resistance in some quarters. Stakeholder interests differ…

  4. Mission Operations Assurance

    Science.gov (United States)

    Faris, Grant

    2012-01-01

    Integrate the mission operations assurance function into the flight team providing: (1) value added support in identifying, mitigating, and communicating the project's risks and, (2) being an essential member of the team during the test activities, training exercises and critical flight operations.

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

    International Nuclear Information System (INIS)

    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)

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

    International Nuclear Information System (INIS)

    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)

  7. Efficacy and Safety of Antifibrinolytic Agents in Reducing Perioperative Blood Loss and Transfusion Requirements in Scoliosis Surgery: A Systematic Review and Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Meng Wang

    Full Text Available Routine use of antifibrinolytic agents in spine surgery is still an issue of debate.To gather scientific evidence for the efficacy and safety of antifibrinolytic agents including aprotinin, tranexamic acid (TXA and epsilon aminocaproic acid (EACA, traditionally known as Amicar in reducing perioperative blood loss and transfusion requirements in scoliosis surgery.We conducted a systematic review and meta-analysis for randomized controlled trials (RCTs, retrospective case-control studies, and retrospective cohort studies on the use of antifibrinolytic agents in scoliosis surgery by searching in the MEDLINE and EMBASE databases and the Cochrane Database of Systematic Reviews and Controlled Trials of papers published from January 1980 through July 2014. Safety of the antifibrinolytic agents was evaluated in all included studies, while efficacy was evaluated in RCTs.Eighteen papers with a total of 1,158 patients were eligible for inclusion in this study. Among them, 8 RCTs with 450 patients were included for evaluation of pharmacologic efficacy (1 RCT was excluded because of a lack of standard deviation data. Mean blood loss was reduced in patients with perioperative use of antifibrinolytic agents by 409.25 ml intraoperatively (95% confidence interval [CI], 196.57-621.94 ml, 250.30 ml postoperatively (95% CI, 35.31-465.30, and 601.40 ml overall (95% CI, 306.64-896.16 ml. The mean volume of blood transfusion was reduced by 474.98 ml (95% CI, 195.30-754.67 ml. The transfusion rate was 44.6% (108/242 in the patients with antifibrinolytic agents and 68.3% (142/208 in the patients with placebo. (OR 0.38; 95% CI; 0.25-0.58; P<0.00001, I2 = 9%. All studies were included for evaluation of safety, with a total of 8 adverse events reported overall (4 in the experimental group and 4 in the control group.The systematic review and meta-analysis indicated that aprotinin, TXA, and EACA all significantly reduced perioperative blood loss and transfusion requirements

  8. Reliability and quality assurance on the MOD 2 wind system

    Science.gov (United States)

    Mason, W. E. B.; Jones, B. G.

    1981-01-01

    The Safety, Reliability, and Quality Assurance (R&QA) approach developed for the largest wind turbine generator, the Mod 2, is described. The R&QA approach assures that the machine is not hazardous to the public or to the operating personnel, is operated unattended on a utility grid, demonstrates reliable operation, and helps establish the quality assurance and maintainability requirements for future wind turbine projects. The significant guideline consisted of a failure modes and effects analysis (FMEA) during the design phase, hardware inspections during parts fabrication, and three simple documents to control activities during machine construction and operation.

  9. 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...

  10. Operational safety

    International Nuclear Information System (INIS)

    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

  11. Revision of Krsko NPP Quality Assurance Plan

    International Nuclear Information System (INIS)

    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

  12. An operational health physics quality assurance program

    International Nuclear Information System (INIS)

    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

  13. The Use of Back-up Units to Enhance the Safety of Unrelated Donor Cord Blood Transplantation

    OpenAIRE

    Ponce, Doris M.; Lubin, Marissa; Gonzales, Anne Marie; Byam, Courtney; Wells, Deborah; Ferrante, Rosanna; Heller, Glenn; Giralt, Sergio; Papadopoulos, Esperanza B.; Kernan, Nancy A.; Scaradavou, Andromachi; Barker, Juliet N.

    2012-01-01

    The inability to obtain additional stem cells is a disadvantage of unrelated donor cord blood (CB) transplantation (CBT). Moreover, in the event of problems with unit shipment, compromised unit quality, thaw mishaps, or graft failure, the time to secure a back-up graft could be unacceptable. Emergent shipment of 1-2 back-up units that have been previously typed and reserved could overcome this limitation. However, the advantages of this approach are not established. Therefore, we present our ...

  14. THE PROBLEMS OF PROVIDING INFECTIOUS DISEASE SAFETY FOR ORGAN AND TISSUE DONATION BY SCREENING BLOOD-BORNE VIRAL INFECTIONS

    OpenAIRE

    M. Sh. Khubutiya; S. A. Solonin; M. A. Godkov

    2016-01-01

    It provided data on the prevalence, clinical signifi cance and methods of laboratory diagnostics for occult forms of blood-borne viral infections (BBVIs). It considered causes of such forms of infection and their signifi cance for clinical transplantation. We analyzed the existing algorithm of laboratory screening of a potential organ donor for BBVIs in Russia. It is shown that the current screening algorithm doesn’t allow detecting hidden forms of BBVIs.

  15. Safety and tolerability of fixed antihypertensive combinations in blood pressure control: focus on olmesartan medoxomil and amlodipine combination

    OpenAIRE

    Ijlal Uddin; Shakil Aslam

    2010-01-01

    Ijlal Uddin, Shakil AslamDivision of Nephrology and Hypertension, Georgetown University Hospital, Washington, District of Columbia, USAAbstract: Hypertension is a major health problem worldwide and remains underdiagnosed and undertreated. Although public awareness and control of hypertension have improved over the last decade, only one-third of hypertensive patients achieve the rather conservative blood pressure (BP) goal of <140/90 mmHg. Most hypertensive patients require more than on...

  16. Revenue assurance in utilities

    OpenAIRE

    Rihar, Miha

    2010-01-01

    In recent times utility companies have to orient to effective business due to hard market conditions. Thus, companies want to diminish business expenses and increase the revenues. Effective revenue capture is, after all, the aim of revenue assurance. Actually the revenue capture is usually not perfect and without losses. A part of revenues are always lost on the way from a service to payment, which is called revenue leakage and causes a financial loss. The revenue leakage is above all the ...

  17. 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

  18. Revenue assurance methodology

    OpenAIRE

    Filipová, Michaela

    2006-01-01

    Práce se zabývá návrhem uceleného teoreticko-metodologického rámce nové podnikové funkce revenue assurance pro telekomunikační společnosti, které usilují o systematický a koncepční přístup k zajištění a maximalizaci příjmů. Popsány jsou role revenue assurance funkce v podniku, cíle, vývojová stádia. Dále jsou popsány hrozby a konkrétní podoby úniků a nadhodnocení příjmů. Podrobně je rozebrána metodika pro plnění úkolů revenue assurance a techniky pro eliminaci úniků a nadhodnocení příjmů. Prá...

  19. Measurement quality assurance

    International Nuclear Information System (INIS)

    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

  20. Specified assurance level sampling procedure

    International Nuclear Information System (INIS)

    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

  1. The safety and immunogenicity of trivalent inactivated influenza vaccination: a study of maternal-cord blood pairs in Taiwan.

    Directory of Open Access Journals (Sweden)

    Shin-Yu Lin

    Full Text Available BACKGROUND: There are little data about adverse effects and immunogenicity of flu vaccine in Asian pregnant women. METHODS: This prospective trial (NCT01514708 enrolled 46 pregnant women who received a single intramuscular dose of trivalent flu vaccine (AdimFlu-S® containing 15 mcg of hemagglutinin for each strain/0.5 mL from influenza A (H1N1, influenza A (H3N2, and influenza B after the first trimester. Blood samples were collected at day 0 and 28 after vaccination, and at delivery. Cord blood was also collected. Hemagglutination inhibition (HAI assays were performed to determine seroprotection and seroconversion rates and fold increase in the HAI geometric mean titer (GMT. RESULTS: Twenty-eight days after vaccination the seroprotection rate against H1N1, H3N2, and influenza B was 91.3%, 84.8% and 56.5%, respectively. The GMT fold increase was 12.8, 8.4, and 4.6 for H1N1, H3N2, and influenza B, respectively. At delivery, both the seroprotection rate (86.4%, 68.2%, and 47.7% and GMT fold increase (9.4, 5.7 and 3.8 were slightly lower than day 28. The seroprotection rate and GMT fold increase in maternal and cord blood samples were comparable. No significant adverse effects were detected. CONCLUSIONS: Trivalent flu vaccine induces a strong immune response in pregnant women and their infants without adverse effects. TRIAL REGISTRATION: Clinical Trials. gov NCT01514708.

  2. Quality assurance program. Braun topical report 21

    International Nuclear Information System (INIS)

    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.)

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

    International Nuclear Information System (INIS)

    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

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

    Science.gov (United States)

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

    1993-03-01

    The role of the quality assurance liaison, the responsibilities of this position, and the evolutionary changes in duties over the last six years are described. 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.

  5. Medical radio-physics. Quality assurance. Transparency

    International Nuclear Information System (INIS)

    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.)

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

    International Nuclear Information System (INIS)

    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.''

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

    DEFF Research Database (Denmark)

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

    2013-01-01

    BACKGROUND: Transfusion of red blood cells (RBC) is recommended in septic shock and the majority of these patients receive RBC transfusion in the intensive care unit (ICU). However, benefit and harm of RBCs have not been established in this group of high-risk patients. METHODS: The Transfusion Re...... after 500 patients, and the Data Monitoring and Safety Committee will recommend the trial be stopped if a group difference in 90-day mortality with P......BACKGROUND: Transfusion of red blood cells (RBC) is recommended in septic shock and the majority of these patients receive RBC transfusion in the intensive care unit (ICU). However, benefit and harm of RBCs have not been established in this group of high-risk patients. METHODS: The Transfusion...... Requirements in Septic Shock (TRISS) trial is a multicenter trial with assessor-blinded outcome assessment, randomising 1,000 patients with septic shock in 30 Scandinavian ICUs to receive transfusion with pre-storage leuko-depleted RBC suspended in saline-adenine-glucose and mannitol (SAGM) at haemoglobin...

  8. 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. PMID:26778839

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

    Directory of Open Access Journals (Sweden)

    Kamendi Harriet W

    2011-01-01

    Full Text Available Abstract Background 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. Method 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. Results 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. Conclusion 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.

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

    Directory of Open Access Journals (Sweden)

    Archana Solanki

    2016-01-01

    Full Text Available Background: 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. Materials and Methods: 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. Results: 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. Conclusion: 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.

  11. U.S. Coast Guard, Office of Boating Safety

    Science.gov (United States)

    ... Report Recalls Product Assurance Branch Boating Safety Circulars Beacon Alerts Marine Safety Alerts Multimedia PSA's Image Library ... Grants Nonprofit Organization Grants Grant Archives Grant Links Beacon Alerts MARINE SAFETY ALERT ISSUED FOR FOAM LIFE ...

  12. Promotion of a good safety culture at Ignalina RBMKs

    International Nuclear Information System (INIS)

    The presentation discusses the following issues: politics of Ignalina nuclear power plant in the area of safety and quality assurance; check of safety conditions; the activities of the Safety committee at the Ignalina NPP

  13. 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.)

  14. CLASSIFICATION OF THE MGR HEALTH SAFETY SYSTEM

    International Nuclear Information System (INIS)

    The purpose of this analysis is to document the Quality Assurance (QA) classification of the Monitored Geologic Repository (MGR) health safety system structures, systems and components (SSCs) performed by the MGR Safety Assurance Department. This analysis also provides the basis for revision of YMP/90-55Q, Q-List (YMP 1998). The Q-List identifies those MGR SSCs subject to the requirements of DOE/RW-0333P, ''Quality Assurance Requirements and Description'' (QARD) (DOE 1998)

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

    International Nuclear Information System (INIS)

    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

  16. 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.

  17. 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.

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

    International Nuclear Information System (INIS)

    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

  19. Regulatory inspection of the implementation of quality assurance programmes

    International Nuclear Information System (INIS)

    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

  20. Regulatory inspection of the implementation of quality assurance programmes

    International Nuclear Information System (INIS)

    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

  1. Efficacy and safety of integrative medical program based on blood cooling and detoxification recipe in treating patients with hepatitis B virus related acute-on-chronic liver failure:a randomized controlled clinical study

    Institute of Scientific and Technical Information of China (English)

    刘慧敏

    2014-01-01

    Objective To evaluate the clinical efficacy and safety of integrative medical program based on blood cooling and detoxification recipe(BCDR)in treating patients with hepatitis B virus related acute-on-chronic liver failure(HBV-ACLF)of heat-toxicity accumulation syndrome(HTAS).Methods Adopting randomized controlled

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

    NARCIS (Netherlands)

    B. O'Dwyer

    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 o

  3. Quality assurance during site construction of nuclear power plants

    International Nuclear Information System (INIS)

    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

  4. Quality assurance of radiation therapy machines

    International Nuclear Information System (INIS)

    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)

  5. 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.

  6. Subsurface quality assurance practices

    International Nuclear Information System (INIS)

    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

  7. Construction quality assurance report

    Energy Technology Data Exchange (ETDEWEB)

    Roscha, V.

    1994-09-08

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

  8. 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..

  9. Construction quality assurance report

    International Nuclear Information System (INIS)

    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

  10. FESA Quality Assurance

    CERN Document Server

    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.

  11. Operational and environmental safety

    International Nuclear Information System (INIS)

    The responsibility of the DOE Office of Operational and Environmental Safety is to assure that DOE-controlled activities are conducted in a manner that will minimize risks to the public and employees and will provide protection for property and the environment. The program supports the various energy technologies by identifying and resolving safety problems; developing and issuing safety policies, standards, and criteria; assuring compliance with DOE, Federal, and state safety regulations; and establishing procedures for reporting and investigating accidents in DOE operations. Guidelines for the radiation protection of personnel; radiation monitoring at nuclear facilities; an assessment of criticality accidents by fault tree analysis; and the preparation of environmental, safety, and health standards applicable to geothermal energy development are discussed

  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. Project Specific Quality Assurance Plan

    International Nuclear Information System (INIS)

    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

  14. Project Specific Quality Assurance Plan

    Energy Technology Data Exchange (ETDEWEB)

    Pedersen, K.S.

    1995-09-27

    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. Quality assurance auditing for nuclear power plants

    International Nuclear Information System (INIS)

    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

  16. Legacy Management CERCLA Sites. Quality Assurance Project Plan

    International Nuclear Information System (INIS)

    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

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

    International Nuclear Information System (INIS)

    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

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

    International Nuclear Information System (INIS)

    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

  19. Weaving an Assurance Case from Design: A Model-Based Approach

    OpenAIRE

    Kelly, Tim; Hawkins, Richard David; Habli, Ibrahim; Kolovos, Dimitris; Paige, Richard Freeman

    2015-01-01

    Assurance cases are used to demonstrate confidence in properties of interest for a system, e.g. For safety or security. A model-based assurance case seeks to bring the benefits of model-driven engineering, such as automation, transformation and validation, to what is currently a lengthy and informal process. In this paper we develop a model-based assurance approach, based on a weaving model, which allows integration between assurance case, design and process models and meta-models. In our app...

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

    International Nuclear Information System (INIS)

    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

  1. Determinants for conducting food safety culture research

    NARCIS (Netherlands)

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

    2016-01-01

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

  2. 49 CFR 385.321 - What failures of safety management practices disclosed by the safety audit will result in a...

    Science.gov (United States)

    2010-10-01

    ... disclosed by the safety audit will result in a notice to a new entrant that its USDOT new entrant... MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.321 What failures of safety management practices disclosed by the safety audit will result in a...

  3. Quality assurance in tissue banking

    International Nuclear Information System (INIS)

    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

  4. Quality assurance for HTR fuels

    International Nuclear Information System (INIS)

    Quality Assurance (QA) for a nuclear fuel is no different from that for any other complex manufacturing process and product. However, such fuel cannot be functionally tested before use even though the consequences of a failure - e.g. lack of electricity production - are particularly costly. Risk assessment may be used to define the confidence level required and this will normally imply a ''three-legged stool'' approach to QA, the three equally vital supporting areas being validated manufacture, Quality Control and Quality Audit. In HTR fuel, primary fission product containment is achieved on a microscale by the use of carbon and silicon carbide coating barriers, pyrolytically deposited on actinide materials in the form of small spherical kernels. The coated particles are dispersed in a graphite matrix and used either as spherical balls in a pebble-bed reactor or carried as cylindrical fuel bodies in hexagonal fuel elements of a prismatic HTR. This paper reviews the QA information which has been published for HTR fuels. Over the last four years the subject has benefited from the Dragon Project having organized an international working party for discussion of QA for HTR fuels. It is important to form strong linkages at the outset between Design, Manufacture, Quality and Performance to establish the specification. The specification, derived from two main types of requirement, functional and safety, is the result of an iterative process working back from the final product aided by a Quality Factor classification. For each manufacturing step along this chain a series of input-output relationships is defined, and it is shown, with examples, how Quality Control is applied throughout as a mixture of input, in-process and output controls. The emphasis is on the primary importance of getting the product right first time. It is concluded that general experience with HTR fuel is good and the next phase of work must be mainly concerned with large-scale validation under non

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

    NARCIS (Netherlands)

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

    2016-01-01

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

  6. Ballistic quality assurance

    International Nuclear Information System (INIS)

    This review describes the ballistic quality assurance for stereotactic intracranial irradiation treatments delivered with Gamma KnifeR 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)

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2006-07-01

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

  8. Quality assurance during commissioning and operation of nuclear power plants

    International Nuclear Information System (INIS)

    This Safety Guide provides requirements and recommendations for the establishment and implementation of a quality assurance programme for activities important to safety during the commissioning, operation and decommissioning phases of a nuclear power plant. It applies to activities such as: the commissioning, inspecting, testing, operating, refuelling, maintaining, repairing, modifying and eventually shutting down and decommissioning of nuclear power plants. It also applies to associated activities related to safety, such as radiation protection, environmental monitoring, handling of radioactive wastes, responses to emergencies and physical security

  9. Quality assurance during operation of nuclear power plants

    International Nuclear Information System (INIS)

    This Safety Guide provides requirements and recommendations for the establishment and implementation of quality assurance for activities important to safety during commissioning, operation and decommissioning of a nuclear power plant, hereinafter referred to in this Guide as the operation phase or operation. It applies to activities such as: operating, inspecting, testing, commissioning, refuelling, maintaining, repairing, modifying and eventual shut-down and decommissioning of nuclear power plants. It applies also to associated activities related to safety, such as environmental monitoring and responses to emergencies

  10. Creating quality assurance and international transparency for quality assurance agencies

    DEFF Research Database (Denmark)

    Lindeberg, Tobias Høygaard; Kristoffersen, Dorte

    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‐membership provision as a basis for the evaluative procedure; and second, the pros and cons of using mutual recognition as international evaluative procedure compared with other approaches....

  11. Enhancing Transfusion Safety: Nurse’s Role

    Directory of Open Access Journals (Sweden)

    Kyriazi Vasiliki

    2011-01-01

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

  12. Safety Considerations at Construction Sites in Kuwait

    OpenAIRE

    M. A. Ezz Al Din

    1990-01-01

    The importance of safety at construction sites is explained with some background study about related matters which should be checked in order to assure safety. Some superintendents think that safety may obstruct productive work but this is not true. Whenever job pressures increase, safety performance will decrease. Also, job control has great effect on safety at sites. These two concepts are explained with the help of two studies. Interviews were made with the safety department personnel in K...

  13. FOOD SAFETY: WHAT IS ECONOMISTS' VALUE ADDED?

    OpenAIRE

    Julie A Caswell

    2003-01-01

    Economists are contributing to the food safety arena by analyzing demand for food safety, the consumer level benefits of improved food safety, the costs and benefits to companies from quality assurance for food safety, and the benefits and costs of government regulations aimed at improving food safety. In the food safety area, too much attention has been paid to risk assessment and not enough to risk management. Economists have a very important role to play in improving private and public ris...

  14. Blood Clots

    Science.gov (United States)

    ... Index A-Z Blood Clots Blood clots are semi-solid masses of blood that can be stationary (thrombosis) ... treated? What are blood clots? Blood clots are semi-solid masses of blood. Normally, blood flows freely through ...

  15. Comparison of three age groups regarding safety and efficacy of drug-eluting stents (from the National Heart, Lung, and Blood Institute Dynamic Registry).

    Science.gov (United States)

    Bainey, Kevin R; Selzer, Faith; Cohen, Howard A; Marroquin, Oscar C; Holper, Elizabeth M; Graham, Michelle M; Williams, David O; Faxon, David P

    2012-01-15

    Limited data exist regarding drug-eluting stent (DES) versus bare metal stent (BMS) use in older patients. From the National Heart, Lung, and Blood Institute Dynamic Registry, 5,089 percutaneous coronary intervention (PCI)-treated patients were studied (October 2001 to August 2006). The differences in 1-year safety (death, myocardial infarction, and their composite) and efficacy (target vessel revascularization [TVR] with PCI and repeat revascularization) outcomes were compared between the patients who received DESs versus BMSs within each age group: <65 years (n = 2,680); 65 to 79 years (n = 1,942); ≥80 years (n = 443). No differences were found in the safety outcomes by stent type in any age group at 1 year. Regarding the effectiveness, lower rates of TVR with PCI and repeat revascularization were observed in the DES patients across all age groups. After propensity-adjusted analysis, the risk of TVR with PCI and repeat revascularization favored DES versus BMS with patients <65 years old (7.4% vs 14.6%, hazard ratio [HR] 0.44, 95% confidence interval [CI] 0.32 to 0.60; 12.3% vs and 17.4%, HR 0.65, 95% CI 0.51 to 0.84, respectively), 65 to 79 years old (4.8% vs 9.5%, HR 0.50, 95% CI 0.31 to 0.80; and 7.6% vs 12.3%, HR 0.62, 95% CI 0.44 to 0.88, respectively), and ≥80 years old (4.5% vs 10.4%, HR 0.15, 95% CI 0.05 to 0.44; and 6.0% vs 14.5%, HR 0.18, 95% CI 0.08 to 0.40, respectively). In conclusion, significant reductions in TVR with PCI and repeat revascularization were noted in all 3 age groups without increases in death or myocardial infarction in this large multicenter PCI registry. Our data support the use of DES, regardless of age. PMID:22000774

  16. Manual on quality assurance for the survey, evaluation and confirmation of nuclear power plant sites

    International Nuclear Information System (INIS)

    The present Manual on Quality Assurance for the Survey, Evaluation and Confirmation of Nuclear Power Plant Sites contains supporting material and illustrates examples for implementing the requirements contained in the Code of Practice on Quality Assurance for Safety in Nuclear Power Plants to the activities of survey, evaluation and confirmation of nuclear power plant sites. At the same time the Code of Practice for Safety in Nuclear Power Plant Siting, and Safety Guides in the siting series contain requirements and recommendations to implement a quality assurance programme in selected activities of the siting process. This manual is intended to provide guidance and illustrate examples on this implementation. During preparation and reviews of this Manual it was found out that the methodology of implementation of the quality assurance programme in siting activities is still under development. For these reasons it was considered appropriate to publish this Manual as a temporary publication for trial use

  17. Safety of nuclear installations

    International Nuclear Information System (INIS)

    The safety philosophy of a PWR type reactor distinguishing three levels of safety, is presented. At the first level, the concept of reactivity defining coefficients which measure the reactivity variation is introduced. At the second level, the reactor protection system establishing the design criteria to assure the high reliability, is defined. At the third level, the protection barriers to contain the consequences of accident evolution, are defined. (M.C.K.)

  18. Quality Assurance: A Balancing Act

    OpenAIRE

    Žváčková Jitka

    2015-01-01

    Language Centre Quality Assurance can be used for a wide range of purposes, from audits of services and procedures to reflection on best practices and improvements of language education. Quality Assurance systems across Europe differ considerably. The Czech Republic, unlike the UK or Spain, applies no unified national standards, therefore, the Masaryk University Language Centre (CJV MU), in compliance with the Masaryk University strategic plan, is obliged to set its own standards and procedur...

  19. Outcomes of 167 healthy sibling donors after peripheral blood stem cell mobilization with G-CSF 16μg/kg/day: efficacy and safety.

    Science.gov (United States)

    Krejci, M; Janikova, A; Folber, F; Kral, Z; Mayer, J

    2015-01-01

    Mobilization of peripheral blood stem cells (PBSC) using the granulocyte colony-stimulating factor (G-CSF) has enabled the collection even from older donors and those with comorbidities. Several clinical parameters have been reported to predict the success of PBSC mobilization. The aim of our study was to evaluate the safety of PBSC donation in a cohort of 167 sibling donors after mobilization with G-CSF 16 μg/kg/day for 5 days during short- and long term follow-up and to analyse the efficacy, toxicity and factors influencing CD34+ mobilization capacity. All 167 sibling donors completed the established mobilization protocol. The median yield was 7.9x106 CD34 cells/kg per recipient weight. The optimal target dose of CD34 cells ≥ 4.0x106/kg was achieved in 140 donors (84%). Only in 4 donors (2%) was the CD34+ yield toxicities occured.Factors associated with higher PBSC yields included age 51/μL (p 45.5 x 109/L (p = 0.003). Comorbidity score, performance status and donor weight did not significantly influence PBSC yields. Long-term follow-up was possible in 60% (101/167) of the donors. The median length of follow-up from PBSC donation was 11.9 years. Most of these donors reported good or very good general health (91%), and no hematological malignancies were observed.The mobilization of PBSC in sibling donors with G-CSF 16 μg/kg/day is an effective and safe procedure with no significant short- and long-term toxicities. PMID:26278142

  20. Regulatory activities in reactor safety

    International Nuclear Information System (INIS)

    The safety phylosophy in designs and operation of nuclear power plants and, the steps for evaluating the safety and quality assurance, in the licensing procedure are described. The CNEN organization structure and the licensing procedure for nuclear power plants in Brazil are presented. (M.C.K.)

  1. Thoughts on Internal and External Quality Assurance

    Science.gov (United States)

    Zhang, Jianxin

    2012-01-01

    Quality assurance of higher education is made up of two parts: internal quality assurance (IQA) and external quality assurance (EQA). Both belong to a union of the coexistence and balance of yin and yang. But in reality there exists a paradox of "confusion of quality assurance (QA) subject consciousness, singularity of social QA and lack of QA…

  2. 10 CFR 71.37 - Quality assurance.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Quality assurance. 71.37 Section 71.37 Energy NUCLEAR... Package Approval § 71.37 Quality assurance. (a) The applicant shall describe the quality assurance program... quality assurance program that are applicable to the particular package design under...

  3. Quality Assurance Review of SKB's Copper Corrosion Experiments

    International Nuclear Information System (INIS)

    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 out with sufficient quality, so that results can be considered to be reliable within the context of their use in safety assessment. The former named authority, SKI, has initiated a series of reviews of SKB's methods of quality assurance and their implementation. This quality assurance review is focused on the work of copper corrosion being conducted in at SKB's Hard Rock Laboratory (HRL) in Aespoe, LOT and Miniature canister (Minican) experiments. In order for the reviewers to get a broad understanding of the issue of copper corrosion both SKB reports as well as the viewpoint of MKG was collected prior to commencement of the actual review task. The purpose of this project is to assess SKB's quality assurance with the view of providing input for the preparation of the SR-Site safety assessment. This has been achieved by examination of the corrosion part of the LOT and Minican experiments using a check list, visits to the relevant facilities, and meetings with contractors and a few members of the SKB staff. The same approach for quality assurance reviews has been used earlier in similar review tasks. During the quality review of the selected projects, several QA- related issues of different degree of severity was noted by the reviewers. The most significant finding was that SKB has chosen to present only selected real-time corrosion monitoring data in TR-09-20. This was surprising and SSM expect that SKB will analyse the reason for this thoroughly. The reviewers also made other observations which can be

  4. Mechanism of Occult Hepatitis B Virus Infection and Its Effect on Blood Safety%隐匿性乙型肝炎病毒感染的机制及其对血液安全的影响

    Institute of Scientific and Technical Information of China (English)

    张蕾琳; 张轩

    2014-01-01

    血清匀月泽A早阴性者肝组织或血清中仍可检出匀月灾阅晕A,此现象称为隐匿性匀月灾感染(occult hepatitis B virus in-fection,韵月陨)。韵月陨对保障输血安全、临床诊断和匀月灾流行病学监控带来很大困难,进一步阐明其机制有利于韵月陨的预防和治疗。本文综述了近年来对韵月陨发生机制的研究进展、韵月陨对血液安全的影响以及核酸检测工作对血液安全的促进作用。%HBV DNA can be detected in one's serum or liver who is HBsAg negative in serum, and this phenomenon is called occult hepatitis B virus infection (OBI). OBI makes it particularly difficult to ensure blood transfusion safety, make clinical diagnosis and imple-ment epidemiological monitoring of HBV. Further study for the mechanism is beneficial for its prevention and treatment. This paper re-viewed the research progress of the mechanism of OBI in recent years, the impact on blood safety, and the promoting effect on blood safety of nucleic acid test.

  5. NIF Projects Controls and Information Systems Software Quality Assurance Plan

    International Nuclear Information System (INIS)

    Quality achievement for the National Ignition Facility (NIF) and the National Ignition Campaign (NIC) is the responsibility of the NIF Projects line organization as described in the NIF and Photon Science Directorate Quality Assurance Plan (NIF QA Plan). This Software Quality Assurance Plan (SQAP) is subordinate to the NIF QA Plan and establishes quality assurance (QA) activities for the software subsystems within Controls and Information Systems (CIS). This SQAP implements an activity level software quality assurance plan for NIF Projects as required by the LLNL Institutional Software Quality Assurance Program (ISQAP). Planned QA activities help achieve, assess, and maintain appropriate quality of software developed and/or acquired for control systems, shot data systems, laser performance modeling systems, business applications, industrial control and safety systems, and information technology systems. The objective of this SQAP is to ensure that appropriate controls are developed and implemented for management planning, work execution, and quality assessment of the CIS organization's software activities. The CIS line organization places special QA emphasis on rigorous configuration control, change management, testing, and issue tracking to help achieve its quality goals.

  6. NIF Projects Controls and Information Systems Software Quality Assurance Plan

    Energy Technology Data Exchange (ETDEWEB)

    Fishler, B

    2011-03-18

    Quality achievement for the National Ignition Facility (NIF) and the National Ignition Campaign (NIC) is the responsibility of the NIF Projects line organization as described in the NIF and Photon Science Directorate Quality Assurance Plan (NIF QA Plan). This Software Quality Assurance Plan (SQAP) is subordinate to the NIF QA Plan and establishes quality assurance (QA) activities for the software subsystems within Controls and Information Systems (CIS). This SQAP implements an activity level software quality assurance plan for NIF Projects as required by the LLNL Institutional Software Quality Assurance Program (ISQAP). Planned QA activities help achieve, assess, and maintain appropriate quality of software developed and/or acquired for control systems, shot data systems, laser performance modeling systems, business applications, industrial control and safety systems, and information technology systems. The objective of this SQAP is to ensure that appropriate controls are developed and implemented for management planning, work execution, and quality assessment of the CIS organization's software activities. The CIS line organization places special QA emphasis on rigorous configuration control, change management, testing, and issue tracking to help achieve its quality goals.

  7. quality assurance systems in nuclear fuel procurement and manufacturing

    International Nuclear Information System (INIS)

    Quality is the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs. Quality control is activities and techniques used to fulfill the requirements of quality. Quality assurance is a system and its main components are requirements. QA program, organization and responsibilities, design and verification, material and its control, manufacturing and process control, inspections, audits and documents: manuals, specifications, instructions. Quality assurance systems are largely based on ISO 9000 series of the International Standards Organization. ISO 9000 series has been adopted and published by Turkish Standards Institute as TS-ISO 9000. International Atomic Energy Agency also published a guide (50-SG-QA11) ''Quality Assurance in the Procurement, Design and Manufacture of Nuclear Fuel Assemblies'' in the safety guide series. In this study the role of quality control in quality assurance systems, inspection and test plans and acceptance and nonconformance quality levels will be explained in relation to nuclear fuel production. Examples of applications in quality assurance systems based on ISO 9000 will be given

  8. Mixed Waste Integrated Program Quality Assurance requirements plan

    International Nuclear Information System (INIS)

    Mixed Waste Integrated Program (MWIP) is sponsored by the US Department of Energy (DOE), Office of Technology Development, Waste Management Division. The strategic objectives of MWIP are defined in the Mixed Waste Integrated Program Strategic Plan, and expanded upon in the MWIP Program Management Plan. This MWIP Quality Assurance Requirement Plan (QARP) applies to mixed waste treatment technologies involving both hazardous and radioactive constituents. As a DOE organization, MWIP is required to develop, implement, and maintain a written Quality Assurance Program in accordance with DOE Order 4700.1 Project Management System, DOE Order 5700.6C, Quality Assurance, DOE Order 5820.2A Radioactive Waste Management, ASME NQA-1 Quality Assurance Program Requirements for Nuclear Facilities and ANSI/ASQC E4-19xx Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs. The purpose of the MWIP QA program is to establish controls which address the requirements in 5700.6C, with the intent to minimize risks and potential environmental impacts; and to maximize environmental protection, health, safety, reliability, and performance in all program activities. QA program controls are established to assure that each participating organization conducts its activities in a manner consistent with risks posed by those activities

  9. Assurance in Agent-Based Systems

    International Nuclear Information System (INIS)

    Our vision of the future of information systems is one that includes engineered collectives of software agents which are situated in an environment over years and which increasingly improve the performance of the overall system of which they are a part. At a minimum, the movement of agent and multi-agent technology into National Security applications, including their use in information assurance, is apparent today. The use of deliberative, autonomous agents in high-consequence/high-security applications will require a commensurate level of protection and confidence in the predictability of system-level behavior. At Sandia National Laboratories, we have defined and are addressing a research agenda that integrates the surety (safety, security, and reliability) into agent-based systems at a deep level. Surety is addressed at multiple levels: The integrity of individual agents must be protected by addressing potential failure modes and vulnerabilities to malevolent threats. Providing for the surety of the collective requires attention to communications surety issues and mechanisms for identifying and working with trusted collaborators. At the highest level, using agent-based collectives within a large-scale distributed system requires the development of principled design methods to deliver the desired emergent performance or surety characteristics. This position paper will outline the research directions underway at Sandia, will discuss relevant work being performed elsewhere, and will report progress to date toward assurance in agent-based systems

  10. The role of the operating organization in NPP quality assurance

    International Nuclear Information System (INIS)

    In the USSR, quality assurance problems (planning and systematic implementation of activities) associated with the construction and operation of nuclear power plants are the responsibility of the Ministry of Atomic Energy and Industry. One section of that Ministry fulfils the function of the operating body. Corporations that take part in the activities throughout the various stages of the nuclear power plant life are fully responsible for quality assurance in allocated fields only, while the body operating the plant is responsible for the overall fulfilment of the quality assurance plan at the nuclear power plant. The operating body creates the organizational structure necessary for safe nuclear power plant operation; it procures funds, materials, technical means, standards and other technical documentation; organizes physical protection and fire protection of the plant and selection and training of the operating personnel; and it supervises constantly all activities relevant to the safety aspect and is responsible for them. The results of safety-related inspections are submitted by the plant-operating body to State Surveillance and inspection authorities. The plant-operating body elaborates and, together with State Surveillance bodies, approves methodologies and programmes for the preparation and implementation of training in case of accident, and organizes this training. At present, a nuclear power plant quality assurance programme is being prepared taking into account IAEA and ISO recommendations. (Z.S.). 4 refs

  11. Quality assurance in the procurement of items and services for nuclear power plants

    International Nuclear Information System (INIS)

    Since the inception of nuclear power development in the country, maintaining high safety standards has been a matter of prime importance. Atomic Energy Regulatory Board (AERB) has been entrusted with the responsibility of laying down safety standards and framing rules and regulations in respect of regulatory and safety functions envisaged under the Atomic Energy Act of 1962. This safety guide provides guidance for assuring quality in the procurement of items and services important to nuclear power plant safety. While elaborating the requirements stated in the code of practice on quality assurance (QA) for safety in nuclear power plants, this guide provides necessary information to assist managers in the establishment of the QA programme, for procurement of items and services important to nuclear power plant safety

  12. Review of SKB's Quality Assurance Programme

    Energy Technology Data Exchange (ETDEWEB)

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

    2009-06-15

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

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

    International Nuclear Information System (INIS)

    BAM, as the competent authority for approval of special form radioactive material, attaches great importance to a detailed audit of the required quality assurance programmes for design, manufacture, testing, documentation, use, maintenance and inspection. Applicants have to submit, together with their 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. (author)

  14. Quality assurance in individual monitoring

    International Nuclear Information System (INIS)

    Measurement and assessment of radiation dose to the individual radiation worker, called 'Individual monitoring', is one of the most important aspects of radiation protection. International Commission on Radiation Protection (ICRP-75) has outlined three main objectives of personal monitoring viz assessment of the effectively equivalent dose to demonstrate compliance with managerial and regulatory requirements; to contribute to control of operation and design of facilities and in case of accidental overexposure, to provide valuable information for the initiation and support of any health surveillance and treatment. To meet these objectives, it is essential that the measurements are reliable and accurate as defined by National and International Standards. This requires setting up of well defined internal as well as external quality assurance protocol in the individual monitoring program. External quality assurance program is meant to provide a reliable and qualitative as well as quantitative assessment of the service provided by the service provider. In India, individual monitoring is based on CaSO4:Dy based TLD badge and the task of conducting external quality assurance (QA) is being performed by RP and AD, Bhabha Atomic Research Centre. The paper presents the methodology of Quality assurance, Performance evaluation standards and criteria. It discusses the results and important observations of last few QA cycles conducted for all the TLD Labs. The quality assurance check has indicated that the performance of all the Labs is satisfactory in accordance with ANSI as well as Trumpet curve methodology. It provided feedback on further improvements in the quality

  15. Waste Management Quality Assurance Plan

    International Nuclear Information System (INIS)

    Lawrence Berkeley Laboratory's Environment Department addresses its responsibilities through activities in a variety of areas. The need for a comprehensive management control system for these activities has been identified by the Department of Energy (DOE). The WM QA (Waste Management Quality Assurance) Plan is an integral part of a management system that provides controls necessary to ensure that the department's activities are planned, performed, documented, and verified. This WM QA Plan defines the requirements of the WM QA program. These requirements are derived from DOE Order 5700.6C, Quality Assurance, the LBL Operating and Assurance Program Plan (OAP, LBL PUB-3111), and other environmental compliance documents applicable to WM activities. The requirements presented herein, as well as the procedures and methodologies that direct the implementation of these requirements, will undergo review and revisions as necessary. The provisions of this QA Plan and its implementing documents apply to quality-affecting activities performed by and for WM. It is also applicable to WM contractors, vendors, and other LBL organizations associated with WM activities, except where such contractors, vendors, or organizations are governed by their own WM-approved QA programs. References used in the preparation of this document are (1) ASME NQA-1-1989, (2) ANSI/ASQC E4 (Draft), (3) Waste Management Quality Assurance Implementing Management Plan (LBL PUB-5352, Rev. 1), (4) LBL Operating and Assurance Program Plan (OAP), LBL PUB-3111, 2/3/93. A list of terms and definitions used throughout this document is included as Appendix A

  16. Querying Safety Cases

    Science.gov (United States)

    Denney, Ewen W.; Naylor, Dwight; Pai, Ganesh

    2014-01-01

    Querying a safety case to show how the various stakeholders' concerns about system safety are addressed has been put forth as one of the benefits of argument-based assurance (in a recent study by the Health Foundation, UK, which reviewed the use of safety cases in safety-critical industries). However, neither the literature nor current practice offer much guidance on querying mechanisms appropriate for, or available within, a safety case paradigm. This paper presents a preliminary approach that uses a formal basis for querying safety cases, specifically Goal Structuring Notation (GSN) argument structures. Our approach semantically enriches GSN arguments with domain-specific metadata that the query language leverages, along with its inherent structure, to produce views. We have implemented the approach in our toolset AdvoCATE, and illustrate it by application to a fragment of the safety argument for an Unmanned Aircraft System (UAS) being developed at NASA Ames. We also discuss the potential practical utility of our query mechanism within the context of the existing framework for UAS safety assurance.

  17. Fuel Receiving and Storage Station. Nuclear Regulatory Commission's safety evaluation report

    International Nuclear Information System (INIS)

    The safety evaluation report covers design of structures, components, equipment, and systems; nuclear criticality safety; radiological safety; accident analysis; conduct of operations; quality assurance; common defense and security; financial qualifications; financial protection and indemnity requirements; and technical specifications

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

    OpenAIRE

    Orie Yoshinari; Jay Udani; Hiroyoshi Moriyama; Yoshiaki Shiojima; Xiaoming Chien

    2015-01-01

    Background: Nutraceuticals and functional foods are increasingly being used to help manage hypertension. Treatment with either pumpkin or onion can significantly lower systolic and diastolic blood pressure in animal studies. Traditionally, pumpkin has been used to support healthy blood pressure, glucose tolerance and lipid levels. Onion contains high levels of flavonoids, including quercetin, which decreases blood pressure and promotes restoration of healthy endothelial function. However, hum...

  19. Case study India responds to international food safety requirements

    OpenAIRE

    Sareen, Shashi

    2003-01-01

    "As awareness grows about food safety issues, the need for countries to provide greater assurance about the safety and quality of food also grows....This brief reviews (1) how India utilizes the international framework for food safety standards set forth by the Codex Alimentarius Commission (hereafter referred to as Codex), and (2) how India provides safety assurances for exports and promotes access to international markets for exporters." from Text

  20. Traceability and Assurance Protocols in the Global Food System

    OpenAIRE

    Jones, Eluned; Poghosyan, Arsen; Gonzalez-Diaz, Francisco; Bolotova, Yuliya

    2004-01-01

    In the 21st century, the food supply chain has become a complex, interconnected system with strategies that are aimed at creating improved products to satisfy consumers' demand for safer foods. To stay competitive and ensure consumer confidence, agribusiness firms develop and implement strategies that take into account not only traditional economic factors driving the food demand, but also issues such as food safety and quality. Traceability and assurance protocols help agribusiness companies...

  1. Participation in Quality Assurance Programs in the Apple Industry

    OpenAIRE

    Bewsell, Denise; Kaine, Geoff

    2006-01-01

    There are several quality assurance (QA) programs operating in Australia for horticulturalists. The documentation of orchard activities and decision making are key features of any QA system. Activities of interest are management of pest and diseases, irrigation, fertiliser management, and fruit production and packing. This documentation provides a means of tracing product flow and is evidence that growers are acting in an environmentally responsible manner to help achieve food safety. QA syst...

  2. HACCP based quality assurance systems for organic food production systems

    OpenAIRE

    Knight, C.; Stanley, R.

    2007-01-01

    HACCP provides an effective, logical and structured means of assuring food safety. Although first used in food manufacturing operations, HACCP can be – and, increasingly is – applied to food production and handling operations at all stages in the food chain. This includes the primary production sector. The purpose of this paper is to illustrate how the principles of HACCP can be applied to organic production with special reference to the primary sector.

  3. Experience from a national quality assurance system on radiopharmaceuticals

    International Nuclear Information System (INIS)

    A national quality assurance program covering all radiopharmaceuticals used in Denmark was established in 1970. A regulatory system combining official control with a pharmacy service was developed. 15 years experience in the radiopharmaceutical area will be described. This will include a discussion on registration including the evaluation of safety and efficacy and the supply of radiopharmaceuticals. Different ways of surveying the quality of radiopharmaceuticals and results of quality control analysis will be reviewed

  4. Waste Management Quality Assurance Plan

    International Nuclear Information System (INIS)

    The WMG QAP is an integral part of a management system designed to ensure that WMG activities are planned, performed, documented, and verified in a manner that assures a quality product. A quality product is one that meets all waste acceptance criteria, conforms to all permit and regulatory requirements, and is accepted at the offsite treatment, storage, and disposal facility. In addition to internal processes, this QA Plan identifies WMG processes providing oversight and assurance to line management that waste is managed according to all federal, state, and local requirements for waste generator areas. A variety of quality assurance activities are integral to managing waste. These QA functions have been identified in the relevant procedures and in subsequent sections of this plan. The WMG QAP defines the requirements of the WMG quality assurance program. These requirements are derived from Department of Energy (DOE) Order 414.1C, Quality Assurance, Contractor Requirements Document, the LBNL Operating and Assurance Program Plan (OAP), and other applicable environmental compliance documents. The QAP and all associated WMG policies and procedures are periodically reviewed and revised, as necessary, to implement corrective actions, and to reflect changes that have occurred in regulations, requirements, or practices as a result of feedback on work performed or lessons learned from other organizations. The provisions of this QAP and its implementing documents apply to quality-affecting activities performed by the WMG; WMG personnel, contractors, and vendors; and personnel from other associated LBNL organizations, except where such contractors, vendors, or organizations are governed by their own WMG-approved QA programs

  5. Software Safety Demonstration and Idemnification

    OpenAIRE

    Hegna, Odell

    2015-01-01

    In cyber-physical systems, software may control safety-significant operations. This report discusses a method to structure software testing to measure the confidence that algorithms are true to their intended design. The subject matter appears in two main parts: theory, which shows the relationship between discrete systems theory, software, and the actuated automaton; and application, which discusses safety demonstration and indemnification, a safety assurance metric. The recommended form of ...

  6. The Science of Mission Assurance

    Directory of Open Access Journals (Sweden)

    Kamal Jabbour

    2011-01-01

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

  7. Fuel assurance and supply security

    International Nuclear Information System (INIS)

    Differences between uncertainties relating to uranium and to petroleum supplies are analyzed. Uranium is linked simultaneously to energy and to non-proliferation policies. The differences between the countries from which supplies are obtained are also discussed. Efforts of various international organizations to secure assured supplies are considered. The discussions at INFCE (International Nuclear Fuel Cycle Evaluation) are referred to. The part played by USA is outlined: U.S. fuel assurance proposals; analysis of the U.S. proposal. The relationship between petroleum and uranium supplies is examined, and new trends in the petroleum and uranium industries are discussed. (U.K.)

  8. Quality assurance of endoscopy units.

    Science.gov (United States)

    Stebbing, John F

    2011-06-01

    This chapter reflects on how England has led the world in service development and quality assurance of endoscopy. It draws out themes of leadership, strategic vision and organisational culture. It emphasises the pivotal importance of focussing service improvement on enhancing the quality of a patient's experience of endoscopy. It describes the processes used here for quality assurance of endoscopy units and how these have dovetailed with other strands of work in transforming the English endoscopy service. The chapter presents discussion of the responses to accreditation processes and how the design of the JAG Accreditation process maximises its effectiveness. PMID:21764004

  9. Safety philosophy in Plowshare

    International Nuclear Information System (INIS)

    A nuclear device can be detonated safely when it can ascertained that the detonation can be accomplished without injury to people, either directly or indirectly, and without unacceptable damage to the ecological system and natural or man made structures. This philosophy has its origin in the nuclear weapons testing program dating back to the first detonation in 1945 and applies without reservation to PIowshare projects. This paper therefore will outline the mechanics employed by government in implementing this safety philosophy. The talk will describe those type of actions taken by safety oriented organizations and committees to assure that necessary and desirable safety reviews are conducted. (author)

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

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2004-01-01

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

  11. 首次交会对接任务发射场加注安全保障改进%Improvement of safety assurance conditions during spacecraft propellant injection procedure for China's first rendezvous and docking mission

    Institute of Scientific and Technical Information of China (English)

    罗克; 冯雷

    2011-01-01

    载人航天器加注是航天器研制过程中安全风险最高、危险作业工序最多的环节,必须采取严密的安全防护措施,确保万无一失.通过实践探索积累经验,全面周密的设计论证,对原有加注硬件条件进行改造,工作流程进行优化,从而大幅提高本质安全度,并在首次交会对接任务中加以应用和验证,取得了良好的效果,圆满完成了“天宫一号”、“神舟八号”发射任务的加注工作.%The propellant injection for spacecraft at the launch site is the most dangerous procedure in the whole R&D process, which involves many dangerous operations. Strict protective measures must be taken to avoid any mistakes. Based on the experience of previous practices, and by adequate design and discussion aimed at improving the current hardware conditions, the operation procedures for propellant injection of spacecrafts are optimized with a great enhancement of the intrinsic safety. These approaches have been applied in China's first rendezvous and docking mission, which brings about successful accomplishment of the propellant injection of the Tiangong-Ⅰ and Shenzhou-Ⅷ spacecraft.

  12. Safety Management at PUSPATI TRIGA Reactor (RTP)

    International Nuclear Information System (INIS)

    Adequate safety measures and precautions, which follow relevant safety standards and procedures, should be in place so that personnel safety is assured. Nevertheless, the public, visitor, contractor or anyone who wishes to enter or be in the reactor building should be well informed with the safety measures applied. Furthermore, these same elements of safety are also applied to other irradiation facilities within the premises of Nuclear Malaysia. This paper will describes and explains current safety management system being enforced especially in the TRIGA PUSPATI Reactor (RTP) namely radiation monitoring system, safety equipment, safe work instruction, and interconnected internal and external health, safety and security related departments. (author)

  13. DEVELOPMENTS IN BRAZILIAN FOOD SAFETY POLICY

    OpenAIRE

    Elisabete SALAY; Caswell, Julie A.

    1998-01-01

    Brazil is an important case study of food safety policies because it is the eighth largest economy in the world in terms of Gross Domestic Product. Analysis of the policy and quality management initiatives of the Brazilian government shows that recent activities are more strongly oriented toward assuring access to international markets than to assuring the safety of food sold in domestic markets. This orientation has important implications for agribusiness firms operating in Brazil. Consumer ...

  14. Quality assurance manual: Volume 1

    International Nuclear Information System (INIS)

    Stanford Linear Accelerator Center (SLAC) is a DOE-supported research facility that carries out experimental and theoretical research in high energy physics and developmental work in new techniques for particle acceleration and experimental instrumentation. The purpose of this manual is to describe SLAC quality assurance policies and practices in various parts of the Laboratory

  15. Quality Assurance 1992-2012

    Science.gov (United States)

    Brown, Roger

    2012-01-01

    As the author's contribution to a series marking the Golden Jubilee of the Association of University Administrators, he reflects on changes in quality assurance over the past twenty years and speculates on what the future may hold for quality as the association moves into a new and very different competitive regime. He begins by discussing the…

  16. Quality assurance and statistical control

    DEFF Research Database (Denmark)

    Heydorn, K.

    In scientific research laboratories it is rarely possible to use quality assurance schemes, developed for large-scale analysis. Instead methods have been developed to control the quality of modest numbers of analytical results by relying on statistical control: Analysis of precision serves to...

  17. Quality assurance in computing software

    International Nuclear Information System (INIS)

    The paper concerns quality assurance in computing software as applied to the nuclear industry. The emergence of Software Quality Management in systems procurement over the last decade is discussed, as are some of the underlying reasons for its important role in modern procurement practice. Some of the typical aspects of control are highlighted and discussed. (author)

  18. Quality assurance during site construction

    International Nuclear Information System (INIS)

    Quality Assurance for Nuclear Power Plants under consideration of pipe assembling. Flow of Quality Requirements during: - Desing - Construction - Procurement - Prefabrication - Site. Organizational Requirements and Measurements during Erection: - Incoming Control - Material Storage - Surveillance of Tools - Weld Surveillance - Nondestructive Testing - Cleaning - Final Documentation. Qualification and Training of QA Personnel. (orig.)

  19. Policy-Based Security for Wireless Components in High Assurance Computer Systems

    OpenAIRE

    L. A. Wahsheh; J. Alves-Foss

    2007-01-01

    To enable the growth of wireless networks in high assurance computer systems, it is essential to establish a security engineering methodology that provides system security managers with a procedural engineering process to develop computer security policies. Our research demonstrates how wireless communication technology is deployed using the Multiple Independent Levels of Security (MILS) architecture for high assurance computer system design of security and safety-critical multi-enclave syste...

  20. Legacy Management CERCLA Sites. Quality Assurance Project Plan

    Energy Technology Data Exchange (ETDEWEB)

    Riddle, Donna L.

    2007-05-03

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

  1. Dukovany nuclear power plant safety

    International Nuclear Information System (INIS)

    Presentation covers recommended safety issues for the Dukovany NPP which have been solved with satisfactory conclusions. Safety issues concerned include: radiation safety; nuclear safety; security; emergency preparedness; health protection at work; fire protection; environmental protection; chemical safety; technical safety. Quality assurance programs at all stages on NPP life time is described. Report includes description of NPP staff training provision, training simulator, emergency operating procedures, emergency preparedness, Year 2000 problem, inspections and life time management. Description of Dukovany Plant Safety Analysis Projects including integrity of the equipment, modernisation, equipment innovation and safety upgrading program show that this approach corresponds to the actual practice applied in EU countries, and fulfilment of current IAEA requirements for safety enhancement of the WWER 440/213 units in the course of MORAWA Equipment Upgrading program

  2. Quality assurance manual: Volume 2, Appendices

    International Nuclear Information System (INIS)

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

  3. Chemical identification and its quality assurance

    CERN Document Server

    Milman, Boris L

    2013-01-01

    Chemical Identification and its Quality Assurance shows how to apply the principles of quality assurance for qualitative chemical analysis. The principles of identification and metrological basics are presented, in addition to the reliability and errors involved with chemical identification.

  4. Quality assurance - how to involve the employees

    DEFF Research Database (Denmark)

    Jørgensen, Michael Søgaard

    1996-01-01

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

  5. Quality assurance for environmental analytical chemistry: 1980

    International Nuclear Information System (INIS)

    The continuing quality assurance effort by the Environmental Surveillance Group is presented. Included are all standard materials now in use, their consensus or certified concentrations, quality control charts, and all quality assurance measurements made by H-8 during 1980

  6. Process chemistry {ampersand} statistics quality assurance plan

    Energy Technology Data Exchange (ETDEWEB)

    Meznarich, H.K.

    1996-08-01

    This document provides quality assurance guidelines and quality control requirements for Process Chemistry and Statistics. This document is designed on the basis of Hanford Analytical Services Quality Assurance Plan (HASQAP) technical guidelines and is used for governing process chemistry activities.

  7. Characteristics quality system assurance of university programs

    OpenAIRE

    Lucian Ion Medar

    2011-01-01

    Quality assurance program of study requires time, dedication, effort, innovative thinking and creativity. Competitive research programs monitored by quality assurance system to create the desired results on the relationship between learning and teaching methods and assessment.

  8. Quality assurance for environmental analytical chemistry: 1980

    Energy Technology Data Exchange (ETDEWEB)

    Gladney, E.S.; Goode, W.E.; Perrin, D.R.; Burns, C.E.

    1981-09-01

    The continuing quality assurance effort by the Environmental Surveillance Group is presented. Included are all standard materials now in use, their consensus or certified concentrations, quality control charts, and all quality assurance measurements made by H-8 during 1980.

  9. A Safety Argument Strategy for PCA Closed-Loop Systems: A Preliminary Proposal

    OpenAIRE

    Feng, Lu; King, Andrew L.; Chen, Sanjian; Ayoub, Anaheed; Park, Junkil; Bezzo, Nicola; Sokolsky, Oleg; Lee, Insup

    2014-01-01

    The emerging network-enabled medical devices impose new challenges for the safety assurance of medical cyber-physical systems (MCPS). In this paper, we present a case study of building a high-level safety argument for a patient-controlled analgesia (PCA) closed-loop system, with the purpose of exploring potential methodologies for assuring the safety of MCPS.

  10. Quality and safety in radiotherapy

    CERN Document Server

    Pawlicki, Todd

    2010-01-01

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

  11. Integrating quality assurance and research and development

    International Nuclear Information System (INIS)

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

  12. The role of probabilistic safety assessment and probabilistic safety criteria in nuclear power plant safety

    International Nuclear Information System (INIS)

    The purpose of this Safety Report is to provide guidelines on the role of probabilistic safety assessment (PSA) and a range of associated reference points, collectively referred to as probabilistic safety criteria (PSC), in nuclear safety. The application of this Safety Report and the supporting Safety Practice publication should help to ensure that PSA methodology is used appropriately to assess and enhance the safety of nuclear power plants. The guidelines are intended for use by nuclear power plant designers, operators and regulators. While these guidelines have been prepared with nuclear power plants in mind, the principles involved have wide application to other nuclear and non-nuclear facilities. In Section 2 of this Safety Report guidelines are established on the role PSA can play as part of an overall safety assurance programme. Section 3 summarizes guidelines for the conduct of PSAs, and in Section 4 a PSC framework is recommended and guidance is provided for the establishment of PSC values

  13. Development of quality assurance requirements - an international comparison

    International Nuclear Information System (INIS)

    Total quality management strategy and the worldwide introduction of the DIN/ISO 9000 (EN 29 000) series of standards have given new impetus to traditional quality assurance. The most important change must surely be seen in the holistic approach of total quality management and its strict orientation towards customer requirements and satisfaction. International codes and standards for the nuclear industry will also have to be brought into line as part of the process of harmonizing quality assurance system standards. One possible approach is simply to specify a supplementary 'delta' of nuclear-specific requirements to be appended to the broad range of conventional requirements. It is a particular feature of quality-assured procedures in Germany that product and/or component related quality requirements and quality verifications are defined in the specifications of the architect engineer so that full implementation of the requirements from the design phase through to the manufacturing phase is assured. Looking at the development of the European Pressurized Water Reactor (EPR) and the elaboration of 'Common Rules', it is to be anticipated that a major step will be made toward international harmonization of safety criteria. (orig.)

  14. Quality assurance: a burden or an essential tool for management?

    International Nuclear Information System (INIS)

    The role of Quality Assurance in nuclear power plant management is discussed. Customer's satisfaction has always been considered by the supplier as a key factor to achieve his company's prosperity, provided that this satisfaction can be obtained in proper economical conditions. According to ISO standards, to satisfy the customer's need is in fact the definition of quality. Some twenty years ago nuclear safety introduced an additional notion: an evidence of satisfaction of customer's needs shall be provided - this is the Quality Assurance. Many companies on which this requirement was imposed experienced it and, in some cases continue to experience it, as an additional burden, due to the customer's lack of confidence. However, Code 50.C.QA clearly states in its introduction that Quality Assurance is an essential aspect of good management. It is very difficult to segregate the Quality Assurance Programme implementation efficiency from the company management efficiency. The arguments contained in the paper result in the following possible answer to the question in the title: a burden and an essential tool for management. (Z.S.)

  15. An approach to total quality assurance

    International Nuclear Information System (INIS)

    Total Quality Assurance must be based on amalgamating three quality functions: effective quality control, competent inspection, and regularly audited Quality Assurance programmes. In applying these functions the fuel supplier must regard each of his sub-contractors as part of his own works and ensure a common policy of motivated Quality Assurance throughout his own works and those of his suppliers. (author)

  16. 40 CFR 31.45 - Quality assurance.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Quality assurance. 31.45 Section 31.45... Requirements Reports, Records, Retention, and Enforcement § 31.45 Quality assurance. If the grantee's project... quality assurance practices consisting of policies, procedures, specifications, standards,...

  17. 40 CFR 30.54 - Quality assurance.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Quality assurance. 30.54 Section 30.54... NON-PROFIT ORGANIZATIONS Post-Award Requirements Reports and Records § 30.54 Quality assurance. If the... data generation, the grantee shall develop and implement quality assurance practices consisting...

  18. Solar consumer assurance network briefing book

    Energy Technology Data Exchange (ETDEWEB)

    Connor, Lynda

    1980-06-01

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

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

    Science.gov (United States)

    2010-10-01

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

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

    Directory of Open Access Journals (Sweden)

    Orie Yoshinari

    2015-06-01

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

  1. National Patient Safety Foundation

    Science.gov (United States)

    ... Professional Learning Series Webcasts CPPS Review Course E-Learning Patient Safety Curriculum CPPS Review Course Patient Blood Management Reducing Diagnostic Error Health Info Technology Publications Ask Me 3 For ...

  2. Food Safety for Seniors

    Science.gov (United States)

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Food Home Food Foodborne Illness & Contaminants People at Risk of Foodborne Illness To Your Health! Food Safety for Seniors Share Tweet Linkedin Pin it ...

  3. Trends in Area of Safety Communications within Industrial Networks

    OpenAIRE

    Maria Franekova; Ales Janota; Karol Rastocny

    2005-01-01

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

  4. Safety analysis procedures for PHWR

    Energy Technology Data Exchange (ETDEWEB)

    Min, Byung Joo; Kim, Hyoung Tae; Yoo, Kun Joong

    2004-03-01

    The methodology of safety analyses for CANDU reactors in Canada, a vendor country, uses a combination of best-estimate physical models and conservative input parameters so as to minimize the uncertainty of the plant behavior predictions. As using the conservative input parameters, the results of the safety analyses are assured the regulatory requirements such as the public dose, the integrity of fuel and fuel channel, the integrity of containment and reactor structures, etc. However, there is not the comprehensive and systematic procedures for safety analyses for CANDU reactors in Korea. In this regard, the development of the safety analyses procedures for CANDU reactors is being conducted not only to establish the safety analyses system, but also to enhance the quality assurance of the safety assessment. In the first phase of this study, the general procedures of the deterministic safety analyses are developed. The general safety procedures are covered the specification of the initial event, selection of the methodology and accident sequences, computer codes, safety analysis procedures, verification of errors and uncertainties, etc. Finally, These general procedures of the safety analyses are applied to the Large Break Loss Of Coolant Accident (LBLOCA) in Final Safety Analysis Report (FSAR) for Wolsong units 2, 3, 4.

  5. Requirement Assurance: A Verification Process

    Science.gov (United States)

    Alexander, Michael G.

    2011-01-01

    Requirement Assurance is an act of requirement verification which assures the stakeholder or customer that a product requirement has produced its "as realized product" and has been verified with conclusive evidence. Product requirement verification answers the question, "did the product meet the stated specification, performance, or design documentation?". In order to ensure the system was built correctly, the practicing system engineer must verify each product requirement using verification methods of inspection, analysis, demonstration, or test. The products of these methods are the "verification artifacts" or "closure artifacts" which are the objective evidence needed to prove the product requirements meet the verification success criteria. Institutional direction is given to the System Engineer in NPR 7123.1A NASA Systems Engineering Processes and Requirements with regards to the requirement verification process. In response, the verification methodology offered in this report meets both the institutional process and requirement verification best practices.

  6. Quality assurance in the design

    International Nuclear Information System (INIS)

    System- and product-related quality assurance measures are completing one another. Certainly it is possible to detect a lot of defects in the single technical document by well controlled product related quality inspections and to avoid the consequences of these defects; but also a not unimportant part of defects and deviations has its origin in system linked deficiencies. The latter can be detected more easily and more securely by means of system related reviews (System audit, Product audit). But also the sole implementation of system related quality assurance measures keeps the danger to get stuck only in formality and to loose all references to the specific characteristics of the product. (orig./RW)

  7. Large hadron collider (LHC) project quality assurance plan

    International Nuclear Information System (INIS)

    The LHC Quality Assurance Plan is a set of operating principles, requirements, and practices used to support Berkeley Lab's participation in the Large Hadron Collider Project. The LHC/QAP is intended to achieve reliable, safe, and quality performance in the LHC project activities. The LHC/QAP is also designed to fulfill the following objectives: (1) The LHC/QAP is Berkeley Lab's QA program document that describes the elements necessary to integrate quality assurance, safety management, and conduct of operations into the Berkeley Lab's portion of the LHC operations. (2) The LHC/QAP provides the framework for Berkeley Lab LHC Project administrators, managers, supervisors, and staff to plan, manage, perform, and assess their Laboratory work. (3) The LHC/QAP is the compliance document that conforms to the requirements of the Laboratory's Work Smart Standards for quality assurance (DOE O 414.1, 10 CFR 830.120), facility operations (DOE O 5480.19), and safety management (DOE P 450.4)

  8. Large hadron collider (LHC) project quality assurance plan

    Energy Technology Data Exchange (ETDEWEB)

    Gullo, Lisa; Karpenko, Victor; Robinson, Kem; Turner, William; Wong, Otis

    2002-09-30

    The LHC Quality Assurance Plan is a set of operating principles, requirements, and practices used to support Berkeley Lab's participation in the Large Hadron Collider Project. The LHC/QAP is intended to achieve reliable, safe, and quality performance in the LHC project activities. The LHC/QAP is also designed to fulfill the following objectives: (1) The LHC/QAP is Berkeley Lab's QA program document that describes the elements necessary to integrate quality assurance, safety management, and conduct of operations into the Berkeley Lab's portion of the LHC operations. (2) The LHC/QAP provides the framework for Berkeley Lab LHC Project administrators, managers, supervisors, and staff to plan, manage, perform, and assess their Laboratory work. (3) The LHC/QAP is the compliance document that conforms to the requirements of the Laboratory's Work Smart Standards for quality assurance (DOE O 414.1, 10 CFR 830.120), facility operations (DOE O 5480.19), and safety management (DOE P 450.4).

  9. Quality assurance program requirements for research reactors - approved 1976

    International Nuclear Information System (INIS)

    The standard provides requirements for establishing, managing, conducting, and evaluating quality assurance programs for the design, construction, testing, modification and maintenance of research reactors and associated experiments, but not routine reactor operations. In terms of this standard: (1) quality assurance comprises those planned and systematic actions necessary to provide adequate confidence that a structure, system, or component will perform satisfactorily in service; (2) a research reactor is one used for scientific, engineering, or training purposes which operates at: (a) a thermal power level of 1 megawatt or less; or (b) a thermal power level of 10 megawatts or less and does not contain: (i) a flow loop through the core in which fueled experiments are conducted, or (ii) a liquid fuel loading, or (iii) an experimental facility in the core in excess of 16 square inches (103.2 cm2) in cross-section. Quality assurance effort is applied to safety-related items, which are defined as those physical structures, systems, and components whose intended functions are to either prevent accidents that could cause undue risk to the health and safety or the public, or to control and mitigate the consequences of such accidents

  10. Handbook for Inspectors Quality Assurance

    International Nuclear Information System (INIS)

    The contents of this book are regulatory requirements and guidelines including comparison of 10 CFR 50 and ASME section III, determination and applicable codes and standards about current code applicability and instructions of use of figure 1 chart. Also it includes CROSS Reference of regulatory guides and ANSI standards applicable to quality assurance in table 1, applicable IEEE standards for QA with brief description of purpose in table 2, reporting of defects and Noncompliance - 10 CFR 21 and reporting significant deficiencies.

  11. Developing a quality assurance metric

    OpenAIRE

    Love, Steve; Scoble, Rosa

    2006-01-01

    Abstract There are a variety of techniques that lecturers can use to get feedback on their teaching - for example, module feedback and coursework results. However, a question arises about how reliable and valid are the content that goes into these quality assurance metrics. The aim of this article is to present a new approach for collecting and analysing qualitative feedback from students that could be used...

  12. Quality assurance in preschool surveillance.

    OpenAIRE

    Wearmouth, E M; Lambert, P; Morland, R

    1994-01-01

    A quality assurance programme was used to evaluate community and primary care based preschool surveillance using the National Child Health Computer System in 40 examination centres. Quarterly reports were generated from returns from clinical medical officers and general practitioners to list non-attenders, uptake, and timeliness for the four preschool checks. These provided rapid and comparative feedback on personal performance for participating health professionals and led to marked rises in...

  13. 48 CFR 246.470 - Government contract quality assurance actions.

    Science.gov (United States)

    2010-10-01

    ... quality assurance actions. 246.470 Section 246.470 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT QUALITY ASSURANCE Government Contract Quality Assurance 246.470 Government contract quality assurance actions....

  14. Quality assurance of custom software solutions

    OpenAIRE

    Herblan, Miha

    2014-01-01

    In thesis we look at problem of software quality assurance, especially when it comes to custom solutions projects. First we look at what quality assurance is, how do we mesure it and specialty why we do it. Afterwards we go through main principles, that apply when dealing with quality assurance in general. Since quality assurance is extensive topic, we take more detailed look on one part of quality assurance that is mostly used, that is testing of software. Because we are talking about softwa...

  15. Safety culture at Ignalina NPP

    International Nuclear Information System (INIS)

    In accordance with Article 27 of the Law on Nuclear Energy of the Republic of Lithuania, the organization operating the nuclear power facility must ensure adequate safety culture. Safety culture comprises specific features and characteristics of the organisation's activities as well as human behavior ensuring that the issues of a nuclear power facility's safety will be given attention consistent with their importance. To ensure adequate level of safety culture, Ignalina NPP has been following IAEA recommendations. The INPP draws up and implements plans of safety culture assurance every year. The Director General meets with IAEA personnel on a regular basis and discusses issues that hold most interest for them. In 2005, INPP management reviewed and approved on September 30 the new policy of safety and quality assurance. The document differs from the policy approved in 1995 in that priorities are set for INPP decommissioning. It is emphasized that INPP Unit 2 operation must be terminated in the most efficient and safest manner, with adequate social security of the personnel assured and effective management system of the facility maintained. The work commenced in 2004 at the Ignalina NPP on identification and application of safety culture indicators was continued in 2005. (author)

  16. Quality Interaction Between Mission Assurance and Project Team Members

    Science.gov (United States)

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

    2006-01-01

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

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

    International Nuclear Information System (INIS)

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

  18. Blood pressure

    Science.gov (United States)

    ... the walls of the arteries is called blood pressure. Blood pressure is measured both as the heart contracts, which ... as it relaxes, which is called diastole. Normal blood pressure is considered to be a systolic blood pressure ...

  19. Blood transfusions

    Science.gov (United States)

    ... this page: //medlineplus.gov/ency/patientinstructions/000431.htm Blood transfusions To use the sharing features on this ... several sources of blood which are described below. Blood From the Public (Volunteer Blood Donation) The most ...

  20. Blood Basics

    Science.gov (United States)

    ... Patient Group Links Advocacy Toolkit Home For Patients Blood Basics Blood is a specialized body fluid. It ... about 9 pints. Jump To: The Components of Blood and Their Importance Many people have undergone blood ...

  1. Blood Thinners

    Science.gov (United States)

    If you have some kinds of heart or blood vessel disease, or if you have poor blood flow to your brain, your doctor may recommend that you take a blood thinner. Blood thinners reduce the risk of heart ...

  2. Blood culture

    Science.gov (United States)

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

  3. Reliability assurance programme guidebook for advanced light water reactors

    International Nuclear Information System (INIS)

    To facilitate the implementation of reliability assurance programmes (RAP) within future advanced reactor programmes and to ensure that the next generation of commercial nuclear reactors achieves the very high levels of safety, reliability and economy which are expected of them, in 1996, the International Atomic Energy Agency (IAEA) established a task to develop a guidebook for reliability assurance programmes. The draft RAP guidebook was prepared by an expert consultant and was reviewed/modified at an Advisory Group meeting (7-10 April 1997) and at a consults meeting (7-10 October 1997). The programme for the RAP guidebook was reported to and guided by the Technical Working Group on Advanced Technologies for Light Water Reactors (TWG-LWR). This guidebook will demonstrate how the designers and operators of future commercial nuclear plants can exploit the risk, reliability and availability engineering methods and techniques developed over the past two decades to augment existing design and operational nuclear plant decision-making capabilities. This guidebook is intended to provide the necessary understanding, insights and examples of RAP management systems and processes from which a future user can derive his own plant specific reliability assurance programmes. The RAP guidebook is intended to augment, not replace, specific reliability assurance requirements defined by the utility requirements documents and by individual nuclear steam supply system (NSSS) designers. This guidebook draws from utility experience gained during implementation of reliability and availability improvement and risk based management programmes to provide both written and diagrammatic 'how to' guidance which can be followed to assure conformance with the specific requirements outlined by utility requirements documents and in the development of a practical and effective plant specific RAP in any IAEA Member State

  4. Reactor safety research: visible demonstrations and credible computations

    International Nuclear Information System (INIS)

    The Electric Power Research Institute (EPRI) has been conducting nuclear safety research for a number of years with the primary goal of assuring the safety and reliability of nuclear plants by visibly demonstrating the existence of quantified safety margins. Many of the current safety research projects at EPRI are described under the major topics of: source term; seismic research; systems analysis and probabilistic risk assessment; safety margins demonstration; operational and safety implementation of digital technology; and core performance limits and plant transient evaluation

  5. Quality assurance in the manufacture of items for nuclear power plants

    International Nuclear Information System (INIS)

    This Safety Guide provides requirements and recommendations related to the establishment and implementation of a quality assurance programme for those organizations involved in the manufacture of items affecting the safety of nuclear power plants. The quality-assurance-related functions of a manufacturer may include activities such as designing, purchasing, fabricating, handling, shipping, storing, cleaning, inspecting, testing, modifying, repairing and maintaining. It is not the aim of the present Guide, which supplements the above-mentioned Code of Practice, to provide rules related to the quality assurance programme for the design of items. Manufacturers that generate designs shall follow the requirements and recommendations contained in the Safety Guide on Quality Assurance in the Design of Nuclear Power Plants (IAEA Safety Series No. 50-SG-QA6). All these publications form part of the Agency'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. A Provisional List of NUSS Programme Titles will be found at the end of this publication

  6. Assuring Competency in Nuclear Power Plants: Regulatory Policy and Practice

    International Nuclear Information System (INIS)

    approaches to assuring competency, these include: Implementing new programs; Requiring a systematic approach to training (SAT); Responding to audit findings using the IAEA guidelines on training programs; Anticipating and addressing potential problems; Assuring licensee remains an intelligent customer; Assuring competence after organizational changes; Building a new facility: 'pre-regulation' concerns. Outcomes of proactive inspections: Checking on a new regulation; Checking contractor qualifications before an outage; Checking qualifications of managers: two examples; Checking training after a modification; Checking training as part of a quality system review; Outcomes of reactive inspections: In depth evaluation of incident leads to increased attention to competence; Deteriorating performance traced to poor training program; Licensee needs training in root cause analysis; Two licensees lose function that tracks training in safety related positions; The authors noted the following as concluding remarks: Regulators seem to be moving towards more process based regulations and/or process based inspection methods for the oversight of competency. There is increasing attention to training and qualifications of personnel outside of operations, particularly those in maintenance positions. Competency specialists are concerned about the effects of two trends that seem to be increasing - downsizing, and the increased use of contractors. While there is an increased emphasis on human factors areas in nuclear power regulation, there is still an emphasis on technical systems and hardware by regulators and utilities. There is also concern about inadequate availability of expertise in the area of human factors in nuclear power regulators and industry

  7. Vaccine Safety

    Science.gov (United States)

    ... the safety of Tdap, Meningococcal, and HPV vaccines Human Papillomavirus (HPV) Vaccine is Very Safe Read about the safety of ... Hepatitis A Vaccine Safety Hepatitis B Vaccine Safety Human Papillomavirus (HPV) Vaccine Safety FAQs about HPV Safety Influenza (Flu) Vaccine ...

  8. JSC Safety and Mission Assurance Data Analysis Overview

    Science.gov (United States)

    Roelant, Henk

    2010-01-01

    These slides describe the data analysis methods that are used to determine inputs for probabilistic risk models supporting the Space Shuttle Program. Other applications can follow a similar path probably using different data sources. Statistical approaches are different and not addressed here. Topics included here: 1) Prior Distribution; 2) Likelihood Data; 3) Bayesian Updating; and 4) Uncertainty and Error. Note: This is a high-level discussion and is not intended to be a tutorial.

  9. Microbes and blood transfusion

    Directory of Open Access Journals (Sweden)

    Narayan S

    2001-01-01

    Full Text Available Transfusion medicine has been constantly evolving through the years with improved technologies that enhance the capability of identifying existing and newer emerging transfusion transmissible infections (TTI. In spite of the efforts made by blood banks the risk of TTI remains. This article deals with the various steps involved in ensuring blood safety, i.e. donor selection, role of screening donated blood for known and emerging infections, issues and assessment of threat posed by the risk, methodologies employed for testing and possible suggestions to improve transfusion services. While the threat of TTI remains, with a concerted effort of private and government organisations, and co-operation from the diagnostic companies, it is possible to raise the levels of blood safety. A surveillance system is also essential to identify any new agents that might pose a threat in a geographic area and to include them too in the screening process.

  10. Reactor safety systems

    International Nuclear Information System (INIS)

    The spectrum of possible accidents may become characterized by the 'maximum credible accident', which will/will not happen. Similary, the performance of safety systems in a multitude of situations is sometimes simplified to 'the emergency system will/will not work' or even 'reactors are/ are not safe'. In assessing safety, one must avoid this fallacy of reducing a complicated situation to the simple black-and-white picture of yes/no. Similarly, there is a natural tendency continually to improve the safety of a system to assure that it is 'safe enough'. Any system can be made safer and there is usually some additional cost. It is important to balance the increased safety against the increased costs. (orig.)

  11. Organizational Culture and Safety

    Science.gov (United States)

    Adams, Catherine A.

    2003-01-01

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

  12. Digital radiography for quality assurance

    International Nuclear Information System (INIS)

    The digital radiographic system AMICA-401 is described. It is a mobile system originally developed for wall thickness and diameter measurements of insulated and non-insulated pipes which is also suited for quality assurance in fabrication and maintenance. Its advantages are immediate evaluation of images, very short exposure times with reduced radiation loads, and an efficient integrated image processing software. Further, no chemical substances are required for film processing. The system can be used both in mobile and in stationary applications. Practical examples are presented and discussed. (orig.)

  13. Quality assurance and statistical control

    DEFF Research Database (Denmark)

    Heydorn, K.

    1991-01-01

    In scientific research laboratories it is rarely possible to use quality assurance schemes, developed for large-scale analysis. Instead methods have been developed to control the quality of modest numbers of analytical results by relying on statistical control: Analysis of precision serves to...... through the origo. Calibration control is an essential link in the traceability of results. Only one or two samples of pure solid or aqueous standards with accurately known content need to be analyzed. Verification is carried out by analyzing certified reference materials from BCR, NIST, or others; their...

  14. Quality assurance in digital radiography

    International Nuclear Information System (INIS)

    At present, there is no standard way of evaluating performance characteristics of digital radiography systems. Continuous measurements of performance parameters are necessary in order to obtain images of high quality. Parameters of quality assurance in digital radiography, which can be evaluated with simple, quick methods, are spatial resolution, low-contrast detectability, dynamic range and exposure dose. Spatial resolution was determined by a lead bar pattern, whereas the other parameters were measured by commercially available phantoms. Performance measurements of 10 digital subtraction angiography (DSA) units and one digital radiography system for unsubtracted digital radiography were assessed. From these results, recommendations for performance parameter levels will be discussed. (author)

  15. Radiation Hardness Assurance (RHA) Guideline

    Science.gov (United States)

    Campola, Michael J.

    2016-01-01

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

  16. Performance assurance for IT systems

    CERN Document Server

    King, Brian

    2004-01-01

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

  17. Quality assurance in digital radiography

    International Nuclear Information System (INIS)

    At present, there is no standard way of evaluating performance characteristics of digital radiography systems. Continuous measurements of performance parameters are necessary in order to obtain images of high quality. Parameters of quality assurance in digital radiography, which can be evaluated with simple, quick methods, are spatial resolution, low-contrast detectability, dynamic range and exposure dose. Spatial resolution as determined by a lead bar pattern whereas other parameters were measured by commercially available phantoms. Performance measurements of 10 digital subtraction angiography (DSA) units and one digital radiography system for unsubtracted digital radiography were assessed. Recommendations for performance parameter levels are discussed. (author)

  18. Information security assurance lifecycle research

    Institute of Scientific and Technical Information of China (English)

    XIE Cheng-shan; XUJIA Gu-yue; WANG Li

    2007-01-01

    This article proposes that problems of information security are mainly caused by the ineffective integration of people, operation, and technology, and not merely by the poor use of technology. Based on the information lifecycle, a model of the information security assurance lifecycle is presented. The crucial parts of the model are further discussed, with the information risk value and protect level, and the solution in each step of the lifecycle is presented with an ensured information risk level, in term of the integration of people, operation, and technology.

  19. Computer Generated Quality Assurance Reports

    OpenAIRE

    Hoffman, L.; Christenson, J.; Brimley, G.; Woolley, B.; McDonald, K.

    1990-01-01

    For the last 4 years, the Student Health Center at Brigham Young University has maintained its medical records on a computerized system. At present there are over 295,000 records stored on line. This medical data bank is used to generate a number of quality assurance reports designed to monitor the quality of medical care given by physicians and nurse practitioners. The ultimate purpose of these reports will be to attempt to evaluate the cognitive processes used by the clinician to try and pr...

  20. Blood Screening for Influenza

    OpenAIRE

    Hourfar, Michael Kai; Themann, Anna; Eickmann, Markus; Puthavathana, Pilaipan; Laue, Thomas; Seifried, Erhard; Schmidt, Michael

    2007-01-01

    Influenza viruses, including highly pathogenic avian influenza virus (H5N1), could threaten blood safety. We analyzed 10,272 blood donor samples with a minipool nucleic acid amplication technique. Analytical sensitivity of the method was 804 geq/mL and 444 geq/mL for generic influenza primers and influenza (H5N1) subtype–specific primers. This study demonstrates that such screening for influenza viruses is feasible.

  1. Auditing of quality assurance programs for nuclear power plants - September 1980 - (Rev.1)

    International Nuclear Information System (INIS)

    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 structures, systems, and components of nuclear power plants important to safety. Criterion XVIII, Audits, of Appendix B to 10 CFR Part 50 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 auditing of quality assurance programs for nuclear power plants. The Advisory Committee on Reactor Safeguards has been consulted concerning this guide and has concurred in the regulatory position

  2. Manual on quality assurance programme auditing

    International Nuclear Information System (INIS)

    The objective of this Manual is to provide guidance and illustrative examples of the methodology and techniques of internal and external audits that are consistent with the requirements and recommendations of the Code and the Safety Guide. The methodology and techniques are based on the practices of Member States having considerable experience in auditing QA programmes. This Manual is directed primarily towards QA programme auditors and managers and presents methods and techniques considered appropriate for the preparation and performance of audits and the evaluation of results. Its scope includes the techniques and methods used to carry out QA programme audits variously described as 'System', 'Product' and 'Process' audits. The techniques and methods described here may be used as one approach to the evaluation of suppliers' QA capabilities as defined in 50-SG-QA10. Although the Manual is primarily directed towards purchasers and suppliers, it is also relevant to regulatory organizations, such as government offices responsible for quality assurance, which carry out external audits independent of purchasers and suppliers. In such cases similar methods, procedures and techniques may be used

  3. Minimization of radiation by quality assurance

    International Nuclear Information System (INIS)

    In the Federal Republic of Germany there is such a high safety standard for nuclear power plants that very low limiting values for emissions and, consequently, low effective doses were laid down which are in part even lower than the level acknowledged internationally and by the European Community. The greatest part of civilization-dependent radiation exposure of the population is caused by the use of ionizing radiation in medicine, here again by X-ray diagnostics. But the use of radioactive materials for diagnostic and therapeutic purposes also requires corresponding rules, accommodated in the draft amendment for the Radiation Protection Ordinance subject to the principle that any unnecessary radiation exposure of persons is to be avoided and must where possible be restricted in accordance with the state of science and technology. In therapy, especially, radiation has to be handled in accordance with the requirements of medical science. Minimization and optimization of the use of radiation calls for additional and further training of personnel and, moreover, for efforts towards quality assurance, i.e. monitoring of devices and systems and its documentation, strict indications to be established by doctors, gauged, tested devices, low-dose nuclides, and optimized radiation plans, as well as risk-benefit assessments again and again. (TRV)

  4. Temporary disruption of the blood-brain barrier by use of ultrasound and microbubbles: safety and efficacy evaluation in rhesus macaques

    OpenAIRE

    McDannold, Nathan; Arvanitis, Costas D.; Vykhodtseva, Natalia; Livingstone, Margaret S

    2012-01-01

    The blood-brain barrier (BBB) prevents entry of most drugs into the brain and is a major hurdle to the use of drugs for brain tumors and other central nervous system disorders. Work in small animals has shown that ultrasound combined with an intravenously circulating microbubble agent can temporarily permeabilize the BBB. Here, we evaluated whether this targeted drug delivery method can be applied safely, reliably, and in a controlled manner on rhesus macaques using a focused ultrasound syste...

  5. Central Line Associated Blood Stream Infection Rate after Intervention and Comparing Outcome with National Healthcare Safety Network and International Nosocomial Infection Control Consortium Data

    OpenAIRE

    Bukhari, SZ; Banjar, A.; Baghdadi, SS; Baltow, BA; Ashshi, AM; Hussain, WM

    2014-01-01

    Background: Benchmarking of central line associated blood stream infection (CLABSI) rates remains a problem in developing countries due to the variations in surveillance practices and/or infection risk as non-availability of national data. Aim: The aim of the following study was to find out the CLABSI rate before and after central line (CL) bundle intervention and compare the outcome with international surveillance data. Subjects and Methods: This prospective longitudinal cohort study on adul...

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

    Directory of Open Access Journals (Sweden)

    Venkatakrishna Shyamala

    2014-01-01

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

  7. Experience in implementing the criteria set forth in the body of nuclear rules and regulations about quality assurance in a routine laboratory

    International Nuclear Information System (INIS)

    Quality assurance has meanwhile become a buzzword increasingly linked to the demand for certification of management in accordance with ISO 9000. Quality assurance has always held an important position in the body of nuclear rules and regulations. The report covers the experience obtained in implementing the criteria set forth in the body of nuclear rules and regulations, and the organization of quality assurance in the Measurement Laboratory of the Central Safety Department of the Karlsruhe Research Center. (orig.)

  8. Assessment of safety culture at INPP

    International Nuclear Information System (INIS)

    Safety Culture covers all main directions of plant activities and the plant departments involved through integration into the INPP Quality Assurance System. Safety Culture is represented by three components. The first is the clear INPP Safety and Quality Assurance Policy. Based on the Policy INPP is safely operated and managers' actions firstly aim at safety assurance. The second component is based on personal responsibility for safety and attitude of each employee of the plant. The third component is based on commitment to safety and competence of managers and employees of the plant. This component links the first two to ensure efficient management of safety at the plant. The above mentioned components including the elements which may significantly affect Safety Culture are also presented in the attachment. The concept of such model implies understanding of effect of different factors on the level of Safety Culture in the organization. In order to continuously correct safety problems, self-assessment of the Safety Culture level is performed at regular intervals. (author)

  9. The safety of nuclear power plants

    International Nuclear Information System (INIS)

    A general presentation is given of reactor safety philosophy and risk analysis. The Rasmussen report (WASH-1400) is discussed and also the Lewis Commission's evaluation of that report. The future developments in reactor safety technology are outlined with emphasis on quality assurance. (JIW)

  10. Quality assurance in diagnostic ultrasound

    Energy Technology Data Exchange (ETDEWEB)

    Sipilae, Outi, E-mail: outi.sipila@hus.fi [HUS Helsinki Medical Imaging Center, Helsinki University Central Hospital, P.O. Box 340, 00029 HUS (Finland); Mannila, Vilma, E-mail: vilma.mannila@hus.fi [HUS Helsinki Medical Imaging Center, Helsinki University Central Hospital, P.O. Box 340, 00029 HUS (Finland); Department of Physics, University of Helsinki, P.O. Box 64, 00014 Helsinki University (Finland); Vartiainen, Eija, E-mail: eija.vartiainen@hus.fi [HUS Helsinki Medical Imaging Center, Helsinki University Central Hospital, P.O. Box 750, 00029 HUS (Finland)

    2011-11-15

    Objective: To setup a practical ultrasound quality assurance protocol in a large radiological center, results from transducer tests, phantom measurements and visual checks for physical faults were compared. Materials and methods: Altogether 151 transducers from 54 ultrasound scanners, from seven different manufacturers, were tested with a Sonora FirstCall aPerio{sup TM} system (Sonora Medical Systems, Inc., Longmont, CO, USA) to detect non-functional elements. Phantom measurements using a CIRS General Purpose Phantom Model 040 (CIRS Tissue Simulation and Phantom Technology, VA, USA) were available for 135 transducers. The transducers and scanners were also checked visually for physical faults. The percentages of defective findings in these tests were computed. Results: Defective results in the FirstCall tests were found in 17% of the 151 transducers, and in 16% of the 135 transducers. Defective image quality resulted with 15% of the transducers, and 25% of the transducers had a physical flaw. In 16% of the scanners, a physical fault elsewhere than in the transducer was found. Seven percent of the transducers had a concurrent defective result both in the FirstCall test and in the phantom measurements, 8% in the FirstCall test and in the visual check, 4% in the phantom measurements and in the visual check, and 2% in all three tests. Conclusion: The tested methods produced partly complementary results and seemed all to be necessary. Thus a quality assurance protocol is forced to be rather labored, and therefore the benefits and costs must be closely followed.

  11. Quality assurance in diagnostic ultrasound

    International Nuclear Information System (INIS)

    Objective: To setup a practical ultrasound quality assurance protocol in a large radiological center, results from transducer tests, phantom measurements and visual checks for physical faults were compared. Materials and methods: Altogether 151 transducers from 54 ultrasound scanners, from seven different manufacturers, were tested with a Sonora FirstCall aPerioTM system (Sonora Medical Systems, Inc., Longmont, CO, USA) to detect non-functional elements. Phantom measurements using a CIRS General Purpose Phantom Model 040 (CIRS Tissue Simulation and Phantom Technology, VA, USA) were available for 135 transducers. The transducers and scanners were also checked visually for physical faults. The percentages of defective findings in these tests were computed. Results: Defective results in the FirstCall tests were found in 17% of the 151 transducers, and in 16% of the 135 transducers. Defective image quality resulted with 15% of the transducers, and 25% of the transducers had a physical flaw. In 16% of the scanners, a physical fault elsewhere than in the transducer was found. Seven percent of the transducers had a concurrent defective result both in the FirstCall test and in the phantom measurements, 8% in the FirstCall test and in the visual check, 4% in the phantom measurements and in the visual check, and 2% in all three tests. Conclusion: The tested methods produced partly complementary results and seemed all to be necessary. Thus a quality assurance protocol is forced to be rather labored, and therefore the benefits and costs must be closely followed.

  12. Reinforcing Quality Assurance in Romanian Higher Education

    OpenAIRE

    Ana-Maria Dima

    2010-01-01

    Since 1993, the quality assurance system in Romania has gained considerable experience. This experience was recently recognized in 2008 by the ENQA: European Association for Quality Assurance in Higher Education through the admission of ARACIS as a full member of EQAR: the European Quality Assurance Register. The Board of ENQA agreed to grant ARACIS’s full membership of ENQA for five years from 2 June 2009. This article explores the benefits of membership for the Romanian Agency for Quality A...

  13. UMTRA technical assistance contractor quality assurance program plan

    International Nuclear Information System (INIS)

    This Quality Assurance Program Plan (QAPP) provides the primary requirements for the integration of quality functions into all Technical Assistance Contractor (TAC) Project organization activities. The QAPP is the written directive authorized by the TAc Program Manager to accomplish this task and to implement procedures that provide the controls and sound management practices needed to ensure TAC contractual obligations are met. The QA program is designed to use monitoring, audit, and surveillance functions as management tools to ensure that all Project organization functions are executed in a manner that will protect public health and safety, promote the success of the Project, and meet or exceed contract requirements

  14. Life Assurance Strategy for CANDU NPP

    International Nuclear Information System (INIS)

    Nuclear Plants have a nominal 'design life' that forms the basis of equipment specification, economic evaluations and licensing for some jurisdictions. Some component in the plant may require replacement, refurbishing and or rehabilitation during the plant 'design life'. Components which are extremely difficult or economically impossible to replace will place a limit on plant life. Rehabilitation programs completed to date on older CANDU plants to improve reliability of plant components, coupled with R and D programs, experimental data and advanced analytical methods form the basis for CANDU plant component life assurance. Life assurance is verified during plant operation by comprehensive in-service inspection programs and laboratory examinations. The paper provides an overview of the experiences to date on Refurbishment and Rehabilitation programs and some Canadian approaches on the main activities involved in scoping and managing nuclear plant life assurance. A number of proactive programs are underway to anticipate, detect and mitigate potential aging degradation at an early stage to ensure plant safety and reliability. Some of these programs include; systematic plant condition assessment, refurbishment and upgrading programs, environmental qualification programs and a program of examination of components from decommissioned reactors. These programs are part of an overall nuclear power plant maintenance strategy. Beyond life assurance, a longer term approach would be geared towards life extension as a viable option for the future. Recent CANDU designs have benefited from the early CANDU experience and are expected to require less rehabilitation. Examples of changes in CANDU 6 include fuel channel design and adopting a closed component cooling water system. New designs are based on 'design life' longer than that used for economic evaluations. The approach is to design for easy replace ability for components that can be economically replaced. Specific examples

  15. The Assurance of CHRIST to His followers

    OpenAIRE

    Asumadu-Sarkodie, Samuel

    2012-01-01

    The Assurance of CHRIST to His followers. Assurance: grk. Hupostasis meaning: full and sustained confidence and trust; unwavering conviction. There is a favourite Ghanaian proverb which says "if a naked man says he will clothe you, listen to him quietly". Before someone could assure you of something, he must be self-reliant or independent. Christ Jesus has assured His followers because He is capable, has done it before, continues to do it and will do it. Isaiah 50:4-9a; talks about the qualif...

  16. 受血者不规则抗体筛查与临床输血安全的研究%Study on the Safety of Irregular Antibody Screening and Blood Transfusion in Patients

    Institute of Scientific and Technical Information of China (English)

    王波; 凌励

    2015-01-01

    目的:研究受血者不规则抗体的阳性率以及不规则抗体的分布,为提高输血安全性提供有效依据。方法对2013年6月~2015年6月在我院拟输血或者手术备血的5000例患者进行不规则抗体筛选,对抗体的特异性进行分析。结果5000例患者中,一共检出20例为抗体阳性,阳性率为0.4%。不规则阳性患者筛查中非特异性抗体1例,占5%,特异性抗体19例,占95%。特异性分布情况:抗-M最高,其次为抗-D、抗-E、抗-C等。结论筛查不规则抗体能够为临床输血的研究提供事实依据,能够提高临床输血的安全性。%Objective To study the positive rate of irregular antibodies and the distribution of irregular antibodies in the blood,so as to provide an effective basis for improving the safety of blood transfusion.Methods 5 000 cases of patients with blood transfusion or surgery in our hospital from June 2013 to June 2015 were screened by irregular antibodies,and the specificity of the antibody was analyzed.Results In 5 000 patients,the positive was 20 cases,and the positive rate was 0.4%. Irregular positive patients in the screening of non-specific antibodies was 1 cases,accounting for 5%,specific antibodies was 19 cases,accounting for 95%. Specific distribution: Anti–m,the highest,followed by anti-D,anti-E,anti-C,etc.Conclusion Screening irregular antibodies can provide a large amount of evidence for clinical research, which can greatly improve the safety of blood transfusion.

  17. Survival after blood transfusion

    DEFF Research Database (Denmark)

    Kamper-Jørgensen, Mads; Ahlgren, Martin; Rostgaard, Klaus;

    2008-01-01

    of transfusion recipients in Denmark and Sweden followed for up to 20 years after their first blood transfusion. Main outcome measure was all-cause mortality. RESULTS: A total of 1,118,261 transfusion recipients were identified, of whom 62.0 percent were aged 65 years or older at the time of their...... 17 years the SMR remained significantly 1.3-fold increased. CONCLUSION: The survival and relative mortality patterns among blood transfusion recipients were characterized with unprecedented detail and precision. Our results are relevant to assessments of the consequences of possible transfusion......-transmitted disease as well as for cost-benefit estimation of new blood safety interventions....

  18. Radiation safety audit

    International Nuclear Information System (INIS)

    Audit has been seen as one of the effective methods to ensure harmonization in radiation protection. A radiation safety audit is a formal safety performance examination of existing or future work activities by an independent team. Regular audit will assist the management in its mission to maintain the facilities environment that is inherently safe for its employees. The audits review the adequacy of facilities for the type of use, training, and competency of workers, supervision by authorized users, availability of survey instruments, security of radioactive materials, minimization of personnel exposure to radiation, safety equipment, and the required record keeping. All approved areas of use are included in these periodic audits. Any deficiency found in the audit shall be corrected as soon as possible after they are reported. Radiation safety audit is a proactive approach to improve radiation safety practices and identify and prevent any potential radiation accident. It is an excellent tool to identify potential problem to radiation users and to assure that safety measures to eliminate or reduce the problems are fully considered. Radiation safety audit will help to develop safety culture of the facility. It is intended to be the cornerstone of a safety program designed to aid the facility, staff and management in maintaining a safe environment in which activities are carried out. The initiative of this work is to evaluate the need of having a proper audit as one of the mechanism to manage the safety using ionizing radiation. This study is focused on the need of having a proper radiation safety audit to identify deviations and deficiencies of radiation protection programmes. It will be based on studies conducted on several institutes/radiation facilities in Malaysia in 2006. Steps will then be formulated towards strengthening radiation safety through proper audit. This will result in a better working situation and confidence in the radiation protection community

  19. 49 CFR 385.315 - Where will the safety audit be conducted?

    Science.gov (United States)

    2010-10-01

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

  20. 49 CFR 385.309 - What is the purpose of the safety audit?

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false What is the purpose of the safety audit? 385.309... SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.309 What is the purpose of the safety audit? The purpose of a safety audit is to: (a) Provide educational and technical assistance...