Sample records for assuring blood safety

  1. Does a liberal national transfusion law assure blood safety? A survey of blood bank directors' perspectives in Lebanon. (United States)

    Haddad, Antoine; Bou Assi, Tarek; Ammar, Walid; Baz, Elizabeth


    In transfusion medicine today, 'zero risk' has become a universal objective. Thus, we investigated whether the level of blood safety as defined by Lebanese legislation is satisfactory. Our work covered the period from September 2008 to June 2012. First, we studied each chapter in law and regulations, and compared them with the latest French regulations. The standards of Good Manufacturing Practice, characteristics of blood products and their storage, and the overall organization and haemovigilance for recipients and donors are not defined. Our analysis revealed numerous problems in today's blood safety situation. There is, for example, no clear definition or identification of the different blood safety components. Then, we conducted a national survey of blood bank directors to assess their perception of blood safety in Lebanon. Our survey revealed a negative perception (52.4 per cent) of the current blood safety situation, with more than 90 per cent of respondents in favor of national regulatory improvements.

  2. GSFC Safety and Mission Assurance Organization (United States)

    Kelly, Michael P.


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

  3. Causal Models for Safety Assurance Technologies Project (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...

  4. Globalisation and blood safety. (United States)

    Farrugia, Albert


    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

  5. Safety Assurance in NextGen (United States)

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


    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. Dynamic Safety Cases for Through-Life Safety Assurance (United States)

    Denney, Ewen; Pai, Ganesh; Habli, Ibrahim


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

  7. Safety and Mission Assurance Knowledge Management Retention (United States)

    Johnson, Teresa A.


    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 (United States)

    Cianciola, Chris; Crane, Kenneth


    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. 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


    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.

  10. 78 FR 54510 - New Entrant Safety Assurance Program Operational Test (United States)


    ... motor carrier received its USDOT Number. The Agency currently devotes the same resources in travel costs and staff time to on-site reviews of low-risk and higher-risk new entrant motor carriers. The FMCSA... TRANSPORTATION Federal Motor Carrier Safety Administration New Entrant Safety Assurance Program Operational...

  11. Safety assured financial evaluation of maintenance (United States)

    Erguina, Vera

    Management decisions in complex industrial facilities usually consider both the economic and environmental aspects of the plant's performance. For nuclear power plants (NPPs), safety is also a very substantial issue. The objectives of this dissertation are to develop and demonstrate a novel useful conceptual model that could be used to allocate maintenance funds for a nuclear power plant in such a way as to meet all specified safety requirements and objectives, while achieving a high degree of economic performance. The model is based on the general theory that the reliability of a plant at any time is a function of its initial reliability and the maintenance history of the individual plant components (Smith, 1997). Such a model can assist in evaluating strategic management decisions regarding allocation of funds for nuclear power plant maintenance. It could be used as a simulation tool; various scenarios could be studied to answer "what if" questions. Simulations of this type will allow a better understanding of the relationship between maintenance, economic performance, and safety, and consequently will lead to better decision making. The novelty of this model is tied to the intimate relationship that it develops between maintenance activities at a nuclear plant, and their relationship to prescribed safety requirements and to the economic performance of that plant.

  12. Safety Assurance Process for FRMS: eJcase Implementation

    NARCIS (Netherlands)

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


    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

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

    CERN Document Server

    Sittig, Dean F


    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

  14. Nuclear Safety and the Role of Quality Assurance

    Energy Technology Data Exchange (ETDEWEB)

    Kwon, Hyuk-il; Park, Chan-Gook; Nam, Ji-Hee; Kim, Kwan-Hyun; Lee, Young-Gun; Lim, Nam-Jin [Korea Atomic Energy Research Institute, Taejon (Korea, Republic of)


    At the early stage of industrialization, quality of a product is determined and achieved by the skill and know-how of a craftsman who made his product. With the development of industry, however, products were diversified and became increasingly complicated. And, the necessity of quality verification by an independent expert, i.e. inspector, became imperative as a means of quality control and quality assurance. Quality should not be a hostage of a consequent tremendous disaster by an accident or malfunction of a product, but should be achieved by pre-planned and systematic control and management actions to assure safe operations. Quality assurance in the nuclear industry is most important because the failure of a safe operation of nuclear power plants or nuclear facilities would cause tremendous disaster to public safety.

  15. Rigid performance requirements assure public safety by regulations

    Energy Technology Data Exchange (ETDEWEB)

    Nickell, R.E.; Glass, R.E.


    Title 10, Part 71 of the Code of Federal Regulations (10 CFR 71) provides a set of prescriptive performance test requirements for spent nuclear fuel and high-level waste transport packaging containment systems. The hypothetical accident conditions, which involve a sequence of impact, puncture, fire, and water immersion events, are referred to as rigid because of their extremely prescriptive nature. These hypothetical accident events have now been placed within the context of real transportation accidents, at least for conventional austenitic stainless steel/ lead gamma shielded cask designs. The assurance of public safety, including the issue of safety margin for very severe accident events is discussed in this paper for both conventional and innovative cask design concepts. A particular risk assessment approach that follows from work at the Lawrence Livermore National Laboratory is suggested.

  16. Rigid performance requirements assure public safety by regulations

    Energy Technology Data Exchange (ETDEWEB)

    Nickell, R.E.; Glass, R.E.


    Title 10, Part 71 of the Code of Federal Regulations (10 CFR 71) provides a set of prescriptive performance test requirements for spent nuclear fuel and high-level waste transport packaging containment systems. The hypothetical accident conditions, which involve a sequence of impact, puncture, fire, and water immersion events, are referred to as rigid because of their extremely prescriptive nature. These hypothetical accident events have now been placed within the context of real transportation accidents, at least for conventional austenitic stainless steel/lead gamma shielded cask designs. The assurance of public safety, including the issue of safety margin for very severe accident events, is discussed in this paper for both conventional and innovative cask design concepts. A particular risk assessment approach that follows from work at the Lawrence Livermore National Laboratory is suggested. 6 refs., 2 figs.

  17. Assuring consumer safety without animals: Applications for tissue engineering. (United States)

    Westmoreland, Carl; Holmes, Anthony M


    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., 7(th) amendment of the Cosmetics Directive and REACH) are driving researchers to develop and adopt non-animal alternative methods with which to assure human safety. Great strides have been made to this effect, but what other opportunities/technologies exist that could expedite this? Tissue engineering has increasing scope to contribute to replacing animals with scientifically robust alternatives in basic research and safety testing, but is this application of the technology being fully exploited? This review highlights how the consumer products industry is applying tissue engineering to ensure chemicals are safe for human use without using animals, and identifies areas for future development and application of the technology.

  18. Cascade Distillation System Design for Safety and Mission Assurance (United States)

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


    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.

  19. SAFEGUARD: An Assured Safety Net Technology for UAS (United States)

    Dill, Evan T.; Young, Steven D.; Hayhurst, Kelly J.


    As demands increase to use unmanned aircraft systems (UAS) for a broad spectrum of commercial applications, regulatory authorities are examining how to safely integrate them without loss of safety or major disruption to existing airspace operations. This work addresses the development of the Safeguard system as an assured safety net technology for UAS. The Safeguard system monitors and enforces conformance to a set of rules defined prior to flight (e.g., geospatial stay-out or stay-in regions, speed limits, altitude limits). Safeguard operates independently of the UAS autopilot and is strategically designed in a way that can be realized by a small set of verifiable functions to simplify compliance with regulatory standards for commercial aircraft. A framework is described that decouples the system from any other devices on the UAS as well as introduces complementary positioning source(s) for applications that require integrity and availability beyond what the Global Positioning System (GPS) can provide. Additionally, the high level logic embedded within the software is presented, as well as the steps being taken toward verification and validation (V&V) of proper functionality. Next, an initial prototype implementation of the described system is disclosed. Lastly, future work including development, testing, and system V&V is summarized.

  20. Final Report of the NASA Office of Safety and Mission Assurance Agile Benchmarking Team (United States)

    Wetherholt, Martha


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

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


    Bolbate, N


    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.

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


    Westmoreland, Carl; Holmes, Anthony M


    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...

  3. Blood safety in the world updated

    Institute of Scientific and Technical Information of China (English)

    Silvano Wandel


    @@ 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.

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

    Directory of Open Access Journals (Sweden)

    van Duijn Gerrit


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

  5. Management of National Nuclear Power Programs for assured safety

    Energy Technology Data Exchange (ETDEWEB)

    Connolly, T.J. (ed.)


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

  6. [Haemovigilance and blood safety in overseas military]. (United States)

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


    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.

  7. The Safety Journey: Using a Safety Maturity Model for Safety Planning and Assurance in the UK Coal Mining Industry

    Directory of Open Access Journals (Sweden)

    Patrick Foster


    Full Text Available A Safety Maturity Model was developed for use in UK coal mining operations in order to assess the level of compliance and effectiveness with a recently introduced standards based safety management system. The developed model allowed for a “self-assessment” of the maturity to be undertaken by teams from the individual sites. Assessments were undertaken at all sites (surface and underground and in some cases within each site (e.g., underground operations, surface coal preparation plant. Once the level of maturity was established, improvement plans were developed to improve the maturity of individual standards that were weaker than the average and/or improve the maturity as a whole. The model was likened to a journey as there was a strong focus on continual improvement and effectiveness of the standards, rather than pure compliance. The model has been found to be a practical and useful tool by sites as a means of identifying strengths and weaknesses within their systems, and as a means of assurance with the safety management system standards.

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

    NARCIS (Netherlands)

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


    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 p

  9. Feminist Heuristics: Transforming the Foundation of Food Quality and Safety Assurance Systems (United States)

    Kimura, Aya Hirata


    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…

  10. Risk Classification and Risk-based Safety and Mission Assurance (United States)

    Leitner, Jesse A.


    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.

  11. FDA'S food ingredient approval process: Safety assurance based on scientific assessment. (United States)

    Rulis, Alan M; Levitt, Joseph A


    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.

  12. Patient blood management equals patient safety. (United States)

    Zacharowski, Kai; Spahn, Donat R


    Patient blood management (PBM) can be defined in many ways and may consist of hundreds of single measures to improve patient safety. Traditionally, PBM is based on three pillars and defined as (i) optimization of the endogenous red blood cell (RBC) mass through the targeted stimulation of erythropoiesis and the treatment of modifiable underlying disorders; (ii) minimization of diagnostic, interventional, and surgical blood loss to preserve the patient's RBC mass; and (iii) optimization of the patient-specific tolerance to anemia through strict adherence to physiological transfusion thresholds [1-4]. However, for this review, we have chosen the following three peri-interventional parts: (1) diagnosis and therapy of anemia, (2) optimal hemotherapy, and (3) minimization of hospital-acquired anemia. PBM is an evidence-based, multidisciplinary preventive, and therapeutic approach focusing each patient. The PBM concept involves the use of safe and effective medical and surgical methods and techniques designed to prevent peri-interventional anemia, rationalize use of blood products, and set good blood management measures in an effort to improve patient safety and outcome.

  13. Safety of blood and blood products in Scandinavia today. (United States)

    Lindholm, A


    The safety of blood and blood products in Scandinavia today is high. An absolutely safe blood supply is, however, an unattainable goal. The dominating risk is transmission of non-A, non-B virus (NANBV). The calculated per blood unit risk is 1:200. The incidence of cirrhosis due to post-transfusion hepatitis NANB is calculated to at most 0.1% among recipients of blood components from about 5 donors. Other risk factors are transmission of hepatitis B virus (HBV), human immunodeficiency virus (HIV-1) and cytomegalovirus (CMV). The prevalence of HBsAg among first time donors is about 0.05% (Sweden). In Scandinavia, anti-HIV-1 has been found in 0.001% of donations from start of screening in 1985 to December 1987. The prevalence was higher in Denmark, lower in Finland (and perhaps Iceland). The prevalence has declined during the last years. As of June 1988, 117 patients in the Scandinavian countries have been infected by blood components, all but 2 before screening was introduced. Besides these, 226 haemophiliacs have been infected by, in almost all cases, imported clotting factor concentrates before heat treatment was introduced. Most of the infected patients are still asymptomatic. About 70% of blood donors have anti-CMV, a few percent of which will transmit CMV-infection, with severe symptoms, to immunosuppressed patients without anti-CMV.

  14. [Blood transfusion and supply chain management safety]. (United States)

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


    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.

  15. John F. Kennedy Space Center, Safety, Reliability, Maintainability and Quality Assurance, Survey and Audit Program (United States)


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

  16. Safety and Mission Assurance Knowledge Management Retention: Managing Knowledge for Successful Mission Operations (United States)

    Johnson, Teresa A.


    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.

  17. Early Engagement of Safety and Mission Assurance Expertise Using Systems Engineering Tools: A Risk-Based Approach to Early Identification of Safety and Assurance Requirements (United States)

    Darpel, Scott; Beckman, Sean


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

  18. International small dam safety assurance policy benchmarks to avoid dam failure flood disasters in developing countries (United States)

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


    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.

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

    Energy Technology Data Exchange (ETDEWEB)


    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 /sup 238/PuO/sub 2/-fueled organic Rankine cycle turbine power system to provide a design output of 500 to 2000 W. Included in this volume are: launch and flight safety considerations; quality assurance techniques and procedures to be followed through system fabrication, assembly and inspection; and the reliability program made up of reliability prediction analysis, failure mode analysis and criticality analysis. (LCL)

  20. Risk-Informed Safety Assurance and Probabilistic Assessment of Mission-Critical Software-Intensive Systems (United States)

    Guarro, Sergio B.


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

  1. Operational effectiveness and quality assurance mechanisms with stochastic demand of blood supply: blood bank case study. (United States)

    Smith, Alan D


    A general overview of various blood products operational effectiveness and related strategies that can be utilised by service providers (in particular, healthcare providers) is presented in the present study. In terms of the massive volumes of blood products, the North American blood centres collect more than eight million units of whole blood, which represents appropriately 50% of the US and Quebec, Canada?s volunteer donor blood supply. A case study of the quality inspection and inventory control concerns of the Central Blood Bank, located in the metropolitan area of Pittsburgh, PA, is presented. Initially, brief introduction to its general operating environment is followed by sections describing its general situation, quality-service initiatives, and followed by a fairly detailed discussion of the practical applications of lessons learned from the case study.

  2. 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)


    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.

  3. Which agents threaten blood safety in the future? (United States)

    Kitchen, A D; Barbara, J A


    The safety of the blood supply is critical to many parts of modern medicine. In a time when prescriber's and the public's expectations are increasing, it is essential that transfusion services globally ensure the safety of the blood supply. There are, however, many threats to this safety, one being the appearance of new infectious agents. Such agents may be truly 'novel', or may be existing agents, known but not routinely screened for, posing a new or increased threat. However, before an agent is considered to be a true threat to blood safety it must be well characterized, and evidence must be presented that (i) transfusion transmission is a significant route of spread, and (ii) the agent causes significant clinical disease. If either of these criteria are not met, the question has to be asked as to whether the agent is truly a threat to blood safety.

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

    NARCIS (Netherlands)

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


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

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

    NARCIS (Netherlands)

    Stierum, R.; Aarts, J.M.M.J.G.; Boorsma, J.; Bosgra, S.; Caiment, F.; Ezendam, J.; Greuping, R.; Hendriksen, P.; Soeteman-Hernandez, L.G.; Jennen, D.; Kleinjans, J.; Kroese, D.; Kuper, F.; Loveren, van H.; Monshouwer, M.; Russel, F.; Someren, van E.; Tsamou, M.; Groothuis, G.


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

  6. Analysis of Aviation Safety Reporting System Incident Data Associated with the Technical Challenges of the System-Wide Safety and Assurance Technologies Project (United States)

    Withrow, Colleen A.; Reveley, Mary S.


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

  7. Safety and Mission Assurance for In-House Design Lessons Learned from Ares I Upper Stage (United States)

    Anderson, Joel M.


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

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

    Directory of Open Access Journals (Sweden)

    Smit Pieter W


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

  9. 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.


    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)

  10. Material & equipment, procurement & maintenance: Impact on blood safety. (United States)

    Emmanuel, Jean C


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

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

    Energy Technology Data Exchange (ETDEWEB)

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


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

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


    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.

  13. ASVCP guidelines: quality assurance for portable blood glucose meter (glucometer) use in veterinary medicine. (United States)

    Gerber, Karen L; Freeman, Kathleen P


    Portable blood glucose meters (PBGM, glucometers) are a convenient, cost effective, and quick means to assess patient blood glucose concentration. The number of commercially available PBGM is constantly increasing, making it challenging to determine whether certain glucometers may have benefits over others for veterinary testing. The challenge in selection of an appropriate glucometer from a quality perspective is compounded by the variety of analytic methods used to quantify glucose concentrations and disparate statistical analysis in many published studies. These guidelines were developed as part of the ASVCP QALS committee response to establish recommendations to improve the quality of testing using point-of-care testing (POCT) handheld and benchtop devices in veterinary medicine. They are intended for clinical pathologists and laboratory professionals to provide them with background knowledge and specific recommendations for quality assurance (QA) and quality control (QC), and to serve as a resource to assist the provision of advice to veterinarians and technicians to improve the quality of results obtained when using PBGM. These guidelines are not intended to be all-inclusive; rather they provide a minimum standard for management of PBGM in the veterinary setting.

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

    Energy Technology Data Exchange (ETDEWEB)

    Servomaa, A. [ed.


    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)

  15. Campaigns and Awareness Raising Strategies in Traffic Safety (CAST). Deliverable 0.5: Quality assurance report.

    NARCIS (Netherlands)

    Twisk, D. & Hoekstra, T.


    This deliverable describes the quality assurance process and its results. More specifically, the individual requirements and outcomes of the quality assurance process are reported. Furthermore, the implementation of the guidelines that were drawn up in advance are discussed. (Author/publisher)

  16. Netcentric Information Orchestration: Assuring Information and System Quality in Public Safety Networks

    NARCIS (Netherlands)

    Bharosa, N.


    During daily operations, relief agencies such as police, fire brigade and medical services manage information in accordance with their respective processes and organization structure. When disaster strikes, the ad-hoc combinations of such hierarchy based information systems fail to assure high infor

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

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


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

  18. Surgical innovation-enhanced quality and the processes that assure patient/provider safety: A surgical conundrum. (United States)

    Bruny, Jennifer; Ziegler, Moritz


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

  19. Assuring food safety: the complementary tasks and standards of the World Organisation for Animal Health and the Codex Alimentarius Commission. (United States)

    Slorach, S A


    The Agreement on the Application of Sanitary and Phytosanitary Measures of the World Trade Organization specifically recognises the international standards developed by the World Organisation for Animal Health (OIE) and the Codex Alimentarius Commission (CAC). OIE standards focus on animal health and zoonoses and those of the CAC on food safety, but since zoonoses can affect food safety, it is vital that the two organisations cooperate closely to avoid duplication of effort, gaps and conflicting standards. The OIE has established an Animal Production Food Safety Working Group to promote cooperation with the CAC and to act as a steering committee for the OIE's work programme on the development of standards aimed at protecting consumers from foodborne hazards arising from animals at the production level of the food chain. This paper describes briefly how standards are developed by the OIE and the CAC and gives examples of how the tasks and standards of the two organisations complement each other in helping to assure food safety. The areas covered include meat hygiene, the identification and traceability of live animals, model certificates for international trade, antimicrobial resistance, veterinary drugs, animal feed, and salmonellosis.

  20. 76 FR 26300 - Meeting of the Advisory Committee on Blood Safety and Availability (United States)


    ... Human Services (HHS) is hereby giving notice that the Advisory Committee on Blood Safety and... HUMAN SERVICES Meeting of the Advisory Committee on Blood Safety and Availability AGENCY: Department of.... James Berger, Associate Public Health Advisor for Blood, Organ and Tissue Safety, Office of...

  1. 75 FR 61143 - Meeting of the Advisory Committee on Blood Safety and Availability (United States)


    ... Human Services is hereby giving notice that the Advisory Committee on Blood Safety and Availability... HUMAN SERVICES Meeting of the Advisory Committee on Blood Safety and Availability AGENCY: Office of the... INFORMATION CONTACT: Jerry A. Holmberg, PhD, Executive Secretary, Advisory Committee on Blood Safety...

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

    Directory of Open Access Journals (Sweden)

    Pragati Chigurupati


    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.

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

    NARCIS (Netherlands)

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


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

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

    Directory of Open Access Journals (Sweden)

    Manoj S. Charde


    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.

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

    Energy Technology Data Exchange (ETDEWEB)

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


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

  6. Safety assurance of cosmetics in Japan: current situation and future prospects. (United States)

    Inomata, Shinji


    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.

  7. Pathogen Inactivation Technologies: The Advent of Pathogen-Reduced Blood Components to Reduce Blood Safety Risk. (United States)

    Devine, Dana V; Schubert, Peter


    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.

  8. Software Assurance Using Structured Assurance Case Models. (United States)

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


    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 model, which has been widely used for assuring system safety, for its potential application to software assurance. We describe the structured assurance model and examine its application and use for software assurance. We identify strengths and weaknesses of this approach and suggest areas for further investigation and testing.

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

    NARCIS (Netherlands)

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


    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.

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

    NARCIS (Netherlands)

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


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

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


    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.


    Directory of Open Access Journals (Sweden)

    Maria Śmiechowska


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

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


    ... of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue... HUMAN SERVICES Meeting of the Advisory Committee on Blood and Tissue Safety and Availability AGENCY... FURTHER INFORMATION CONTACT: Mr. James Berger, Senior Advisor for Blood and Tissue Safety Policy,...

  14. 78 FR 28848 - Meeting of the Advisory Committee on Blood and Tissue Safety and Availability (United States)


    ... of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue... HUMAN SERVICES Meeting of the Advisory Committee on Blood and Tissue Safety and Availability AGENCY..., and Senior Advisor for Blood and Tissue Safety Policy, Office of the Assistant Secretary for...

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

    Cockburn, Andrew


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

  16. Bacteriological safety of blood collected for transfusion at university of gondar hospital blood bank, northwest ethiopia. (United States)

    Wondimu, Hailegebriel; Addis, Zelalem; Moges, Feleke; Shiferaw, Yitayal


    Background. Transfusion associated bacterial infection has remained more frequent with a sever risk of morbidity and mortality. This study assessed the bacteriological safety of blood collected for transfusion. Method. A cross-sectional study was conducted at University of Gondar hospital blood bank from December 2011 to June 2012. Bacterial isolation, identification, and antimicrobial susceptibility tests were done as per the standard procedure. Chi-square test and P value were used to assess associations between risk factors and the bacterial isolation rate. Results. Twenty-one (15.33%) blood units were found contaminated with bacteria, and 95.24% contamination was due to external sources. The commonly isolated bacteria were Staphylococcus aureus, Coagulase negative Staphylococci, Escherichia coli, Klebsiella species, Streptococci species, Enterobacter species, and Citrobacter species. All of the bacteria isolated were 100% sensitive to Gentamicin, Chloramphenicol, Amoxicillin, and Doxycycline. Multiple antimicrobial resistances were observed in 66.7% of the isolates. Not using glove by phlebotomist, touching disinfected phlebotomy site and double puncture at the same hand or both hands of a donor were found to be risk factors for bacterial contamination. Conclusion. Bacterial contamination of blood to be transfused is a common problem in the hospital. So attention should be given to activities performed at the blood bank for safe transfusion practices.

  17. An outline of a risk assessment-based system of meat safety assurance and its future prospects. (United States)

    Berends, B R; van Knapen, F


    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

  18. Optical biosensors for food quality and safety assurance-a review. (United States)

    Narsaiah, K; Jha, Shyam Narayan; Bhardwaj, Rishi; Sharma, Rajiv; Kumar, Ramesh


    Food quality and safety is a scientific discipline describing handling, preparation and storage of food in ways that prevent food borne illness. Food serves as a growth medium for microorganisms that can be pathogenic or cause food spoilage. Therefore, it is imperative to have stringent laws and standards for the preparation, packaging and transportation of food. The conventional methods for detection of food contamination based on culturing, colony counting, chromatography and immunoassay are tedious and time consuming while biosensors have overcome some of these disadvantages. There is growing interest in biosensors due to high specificity, convenience and quick response. Optical biosensors show greater potential for the detection of pathogens, pesticide and drug residues, hygiene monitoring, heavy metals and other toxic substances in the food to check whether it is safe for consumption or not. This review focuses on optical biosensors, the recent developments in the associated instrumentation with emphasis on fiber optic and surface plasmon resonance (SPR) based biosensors for detecting a range of analytes in food samples, the major advantages and challenges associated with optical biosensors. It also briefly covers the different methods employed for the immobilization of bio-molecules used in developing biosensors.

  19. 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


    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.

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

    Energy Technology Data Exchange (ETDEWEB)

    Lacroix, M. [Canadian Irradiation Center, Research Laboratory in Sciences Applied to Food, INRS-Institut Armand-Frappier, 531 Boulevard des Prairies, Laval, Quebec (Canada)], E-mail:; 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)


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

  1. Applications of radiation processing in combination with conventional treatments to assure food safety: New development (United States)

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


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

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

    Directory of Open Access Journals (Sweden)

    Pietersz RNI


    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 

  3. 76 FR 68192 - Meeting of the Advisory Committee on Blood Safety and Availability (United States)


    ... Blood Safety and Availability AGENCY: Department of Health and Human Services, Office of the Secretary... Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood Safety and Availability (ACBSA) will hold a meeting. The meeting will be...

  4. 75 FR 28619 - Meeting of the Advisory Committee on Blood Safety and Availability (United States)


    ... HUMAN SERVICES Meeting of the Advisory Committee on Blood Safety and Availability AGENCY: Department of... Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood Safety and Availability (ACBSA) will hold a meeting. The meeting will be...

  5. Campaigns and Awareness Raising Strategies in Traffic Safety (CAST). Deliverable 0.3: Programme handbook for Quality Assurance QA procedures.

    NARCIS (Netherlands)

    Twisk, D.


    The Programme Handbook for Quality Assurance (QA) Procedures contains information about the quality assurance process and dissemination of study results. It includes the format to be used for various progress, effort and cost reports and it provides a list of duties for the steering committee and th

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


    Pietersz RNI; van der Meer PF


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

  7. 77 FR 67012 - Meeting of the Advisory Committee on Blood and Tissue Safety and Availability (United States)


    ... of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue... HUMAN SERVICES Meeting of the Advisory Committee on Blood and Tissue Safety and Availability AGENCY..., Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Senior Advisor for Blood Policy...

  8. Blood donor selection and deferral pattern as an important tool for blood safety in a tertiary care hospital

    Directory of Open Access Journals (Sweden)

    Manisha Shrivastava


    Full Text Available Context: Blood donor selection criteria based on science and regulatory rules influence donor as well recipient safety and demographics. Aim: To evaluate and analyze the blood donor deferral pattern and its causes among blood donors in a tertiary care hospital blood bank and to review its influence on blood safety. Settings and Design: Hospital based blood bank, retrospective analysis. Subjects and Methods: The data available as donor deferral record over a period of 13 years from 2001 to 2013 was analyzed. Results: The blood donor deferral rate was 11.5%, the deferral rate in various categories was 4.8%, 4.7%, 1.6%, and 0.3% in Category 1, Category 2, Category 3, and Category 4, respectively. The majority of deferrals were temporary deferrals (62.8% of young donors. The maximum number of donors deferred (28.2% due to a history of jaundice (permanent followed by 19.4% due to low hemoglobin (temporary. History of malaria, intake of medicines, infections, underweight, last blood donation within 3 months (temporary deferral, and history of heart and lung diseases, diabetes, and with suspicious identity (permanent deferral were other major causes identified. Conclusion: The pattern of donor deferral identified is an important tool for blood safety and also provides key areas to focus on a region or policy formulation nationally for donor selection as well ensure donor safety. The value of determining donor deferral pattern by the categories described is in calling back donors deferred due to temporary reasons and can help retain pool of motivated blood donors.

  9. [Quality and quality assurance, a European problem]. (United States)

    Schmitt, H


    The problem of quality and quality assurance for the free exchange of blood and blood products in Europe is discussed. The background of all discussion of quality is the categorical theory of Aristoteles. The philosophical basis is described. The fundamental law of the daily work of a blood center has to be a philosophy of quality which depends on the sociodemographic situation in the region. This basic varies from country to country in Europe. The importance of the supranational bodies in Europe is mentioned. The weightness of the Code of Ethics is discussed. Virus safety, purity and validity of blood and blood products are described as parameters of the quality aspects. Finally it is confirmed that a well running blood program is a multicategorical problem.

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

    DEFF Research Database (Denmark)

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


    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 impro...

  11. 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.


    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

  12. Effect of delayed link failure on probability of loss of assured safety in temperature-dependent systems with multiple weak and strong links.

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, J. D. (ProStat, Mesa, AZ); Oberkampf, William Louis; Helton, Jon Craig (Arizona State University, Tempe, AZ)


    Weak link (WL)/strong link (SL) systems constitute important parts of the overall operational design of high consequence systems, with the SL system designed to permit operation of the system only under intended conditions and the WL system designed to prevent the unintended operation of the system under accident conditions. Degradation of the system under accident conditions into a state in which the WLs have not deactivated the system and the SLs have failed in the sense that they are in a configuration that could permit operation of the system is referred to as loss of assured safety. The probability of such degradation conditional on a specific set of accident conditions is referred to as probability of loss of assured safety (PLOAS). Previous work has developed computational procedures for the calculation of PLOAS under fire conditions for a system involving multiple WLs and SLs and with the assumption that a link fails instantly when it reaches its failure temperature. Extensions of these procedures are obtained for systems in which there is a temperature-dependent delay between the time at which a link reaches its failure temperature and the time at which that link actually fails.

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

    Energy Technology Data Exchange (ETDEWEB)

    Servonmaa, A. [ed.


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

    Directory of Open Access Journals (Sweden)

    H Abolghasemi


    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.

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

    NARCIS (Netherlands)

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


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

  16. Efficacy, Safety and Mechanisms of Blood Flow Restricted Exercise (United States)

    Ploutz-Snyder, Lori


    This 20 minute talk will review studies in the peer-reviewed literature related to the effectiveness of blood flow restricted exercise as an exercise training program. There is controversy regarding the talk with cover the effectiveness of various exercise protocols and these differences will be compared and contrasted. Unpublished data from my laboratory at Syracuse University will be presented (see other abstract), as well as some unpublished work from the labs of Manini, Clark and Rasmussen (none are NASA funded).

  17. 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)


    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.

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

    DEFF Research Database (Denmark)

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


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

  19. Quality assurance of metabolomics. (United States)

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


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

  20. WHO informal consultation on the application of molecular methods to assure the quality, safety and efficacy of vaccines, Geneva, Switzerland, 7-8 April 2005. (United States)

    Shin, Jinho; Wood, David; Robertson, James; Minor, Philip; Peden, Keith


    In April 2005, the World Health Organization convened an informal consultation on molecular methods to assure the quality, safety and efficacy of vaccines. The consultation was attended by experts from national regulatory authorities, vaccine industry and academia. Crosscutting issues on the application of molecular methods for a number of vaccines that are currently in use or under development were presented, and specific methods for further collaborative studies were discussed and identified. The main points of recommendation from meeting participants were fourfold: (i) that molecular methods should be encouraged; (ii) that collaborative studies are needed for many methods/applications; (iii) that basic science should be promoted; and (iv) that investment for training, equipment and facilities should be encouraged.

  1. 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


    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.

  2. Assurance Cases (United States)


    2015 Carnegie Mellon University Assurance Cases Software Engineering Institute Carnegie Mellon University Pittsburgh, PA 15213 Charles B...1. REPORT DATE 26 JAN 2015 2. REPORT TYPE N/A 3. DATES COVERED 4. TITLE AND SUBTITLE Assurance Cases 5a. CONTRACT NUMBER 5b. GRANT NUMBER... Assurance Cases Charles B. Weinstock, January 2015 © 2015 Carnegie Mellon University Copyright 2015 Carnegie Mellon University This material is based upon

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


    ... HUMAN SERVICES Nominations to the Advisory Committee on Blood Safety and Availability AGENCY: Office of... Committee for up to four-year terms. DATES: All nominations must be received no later than 4 p.m. EDT on... nominate themselves for consideration of appointment to the Committee. All nominations must include...

  4. 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


    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.

  5. Blood donation in China: sustaining efforts and challenges in achieving safety and availability. (United States)

    Yin, Yong-Hua; Li, Chang-Qing; Liu, Zhong


    China has entered a new phase in blood safety and availability through persistent efforts in the past decades. Based on national data from 2008 to 2012, we present a comprehensive review on the blood services ranging from policy and organization, supply, donors, screening and processing, and clinical use to government response in contemporary China. Current evidence suggests that the Chinese blood industries, after continual efforts in reforms on the legal framework and national management system, have been in a relatively steady but bottleneck stage. Although the blood industries have had an impressive track record on management and resolving problems, such as low availability, limited donors, deficient laboratory tests, shortage of blood products, and unnecessary clinical usage of blood still exist nationwide. While medical technology and services have seen a rapid increase in progress in recent years, they have not coordinated with the development of the national health care system. This article presents an analysis with detailed data, rich contents, and recent response from the Chinese government, allowing readers to appreciate how China, a country with more than 19.13% of the world's population, has long endeavored to improve safety and availability of blood. Meantime, the article sincerely welcomes the guidance on policymaking and technical assistance from the international community. Data in this article do not include those of Hong Kong, Macao, or Taiwan.

  6. Mission Assurance and Flight Safety of Manned Space Flight: Implications for Future Exploration of the Moon and Mars (United States)

    Kezirian, M. T.


    As NASA implements the nation's Vision for Space Exploration to return to the moon and travel to Mars, new considerations will be be given to the processes governing design and operations of manned spaceflight. New objectives bring new technical challenges; Safety will drive many of these decisions.

  7. Blood transfusions in critical care: improving safety through technology & process analysis. (United States)

    Aulbach, Rebecca K; Brient, Kathy; Clark, Marie; Custard, Kristi; Davis, Carolyn; Gecomo, Jonathan; Ho, Judy Ong


    A multidisciplinary safety initiative transformed blood transfusion practices at St. Luke's Episcopal Hospital in Houston, Texas. An intense analysis of a mistransfusion using the principles of a Just Culture and the process of Cause Mapping identified system and human performance factors that led to the transfusion error. Multiple initiatives were implemented including technology, education and human behaviour change. The wireless technology of Pyxis Transfusion Verification by CareFusion is effective with the rapid infusion module efficient for use in critical care. Improvements in blood transfusion safety were accomplished by thoroughly evaluating the process of transfusions and by implementing wireless electronic transfusion verification technology. During the 27 months following implementation of the CareFusion Transfusion Verification there have been zero cases of transfusing mismatched blood.

  8. Leucoreduction of blood components: an effective way to increase blood safety? (United States)

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


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

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

    Energy Technology Data Exchange (ETDEWEB)

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


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

  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.


    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. 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


    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.

  12. 10 CFR 76.93 - Quality assurance. (United States)


    ... 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...

  13. [Contributions of the Council of Europe's Blood Transfusion Steering Committee to the determination of rules for the selection of donors of blood and blood components and the study of sexual behaviors having an impact on blood safety]. (United States)

    Behr-Gross, M-E; Heiden, M; Norda, R


    In November 2009, the Council of Europe's Blood Transfusion Steering Committee created a group of experts to explore the problem of behaviors having an impact on the management of donors of blood and blood components and on blood transfusion safety in Europe. This ad hoc group sought a harmonised interpretation of temporary exclusion (or temporary deferral), as opposed to permanent exclusion (or permanent deferral), in the context of the selection of donors of blood and blood components. It was also given the mandate to assess, on the basis of available data, the possibility of differentiating "at risk" behaviours from behaviours "at high risk" of contamination by serious infectious diseases transmitted by blood, blood components or derived therapeutic products. The primary objective of this work was to ensure the safety of blood, blood components and derived therapeutic products for future recipients by promoting a risk analysis-based approach, given that some countries envisaged amending their provisions for donor selection. However, a risk analysis can only be performed on groups, not individuals, which may give the impression of a discriminatory approach, so it needed to be justified in the context of transfusion safety. A collaborative project, which included an investigation phase, led to the drafting of a technical memorandum that summarised the data collected in ten Council of Europe member states on the selection criteria for blood donors and the epidemiology of infectious diseases (with a focus on human immunodeficiency virus) in the general population and among blood donors. The technical memorandum was published in 2011 on the European Directorate for the Quality of Medicines and Healthcare website dedicated to this project. A draft resolution of the Committee of Ministers of the Council of Europe was then developed by the Council of Europe's Blood Transfusion Steering Committee. This text was circulated among member and observer states of the Council

  14. Quality and safety of herbal medical products: regulation and the need for quality assurance along the value chains. (United States)

    Heinrich, Michael


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

  15. Water storage equity and safety assurance policy to mitigate potential 'dual-extreme cumulative threats' in agricultural catchments (United States)

    Pisaniello, John D.; Tingey-Holyoak, Joanne L.


    Farm dams that are not managed properly at the individual level can create water storage equity and safety threats to downstream communities and the environment that aggregate at the catchment level: a potential 'dual-extreme cumulative' problem. The paper provides indicative evidence and develops understanding of this novel phenomenon and associated policy needs within the Australian setting comprising dual hydrologic extremes of floods and droughts, further exacerbated by climate change. This is achieved through comparative case studies involving surveys of both dam owner perceptions and dam management practices in four States representing a complete range of integrated policy approaches from weak to strong. Survey results find most farmers do not believe dam maintenance is important, will undertake spillway blocking and do not plan for emergencies. These results are supported by physical on-site findings of farmers neglecting dams and blocking or under-designing spillways, in turn storing more water than they are entitled and creating unsafe dams at both the individual and cumulative levels. From detailed cross-case comparative assessment against policy context, it emerges that on-farm perceptions and practices form a range of 'acceptability' of dam management that directly reflects policy strength and integration in each setting. The paper advances the international small dams policy, agricultural water management and hydrology literatures, evidencing the need for effective integrated policy to mitigate dual extreme cumulative threats. Importantly, guidance is provided to jurisdictions internationally with high inter-annual rainfall variation on how best to design integrated policy that can achieve both water storage equity and safety in agricultural catchments.

  16. NASA's Approach to Software Assurance (United States)

    Wetherholt, Martha


    NASA defines software assurance as: the planned and systematic set of activities that ensure conformance of software life cycle processes and products to requirements, standards, and procedures via quality, safety, reliability, and independent verification and validation. NASA's implementation of this approach to the quality, safety, reliability, security and verification and validation of software is brought together in one discipline, software assurance. Organizationally, NASA has software assurance at each NASA center, a Software Assurance Manager at NASA Headquarters, a Software Assurance Technical Fellow (currently the same person as the SA Manager), and an Independent Verification and Validation Organization with its own facility. An umbrella risk mitigation strategy for safety and mission success assurance of NASA's software, software assurance covers a wide area and is better structured to address the dynamic changes in how software is developed, used, and managed, as well as it's increasingly complex functionality. Being flexible, risk based, and prepared for challenges in software at NASA is essential, especially as much of our software is unique for each mission.

  17. 30 CFR 74.9 - Quality assurance. (United States)


    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality assurance. 74.9 Section 74.9 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH COAL MINE DUST SAMPLING DEVICES Requirements for Continuous Personal Dust Monitors § 74.9 Quality assurance....

  18. [Blood Safety in the XXI century. Transfusion transmitted infectious diseases. International and Mexican view]. (United States)

    Rojo Medina, Julieta


    Currently worldwide, the transfusion of blood components cannot be done without residual risks, as compared to those countries with a high human development index, mostly in Europe, that have blood donation systems based on 100% repeat volunteer donors and use molecular biology techniques in screening for infectious diseases. In Latin America and the Caribbean countries, prevention of transfusion-transmissible diseases requires special and different strategies due to several factors: the high prevalence of replacement donors, their specific geographical location, climate, genetic, and sociocultural status of the population make them vulnerable to endemic diseases such as dengue, malaria, and Chagas disease. Thus it is necessary to create local approaches to increase blood safety and achieve the goals set by the Pan American Health Organization.

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

    Directory of Open Access Journals (Sweden)

    Paula Loureiro


    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.

  20. Quality assurance

    Energy Technology Data Exchange (ETDEWEB)

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


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

  1. The margin of safety in the use of a straight path centrifugal blood pump. (United States)

    Kijima, T; Nojiri, C; Oshiyama, H; Horiuchi, K; Nogawa, A; Hamasaki, H; Ogihara, M; Katsuda, H S; Amano, N; Fukasawa, H


    A new centrifugal blood pump with a rotor that arranges 6 straight paths radially was developed for open heart surgery and temporary circulatory support. We describe comparative studies of the margin of safety in the practical use of the new pump. This pump was evaluated for temperature increase, cavitation, and pressure sensitivity. Two commercially available centrifugal pumps, the Biomedicus cone type and the Sarns 3M impeller type, were used as control pumps. The temperature increase in the new pump was four times slower than in the impeller pump when the outlet and the inlet of the pump was clamped. No sign of cavitation was observed when 0.1 ml air was introduced to the pump inlet under a negative pressure of 200 mm Hg in fresh bovine blood. As for pressure sensitivity of centrifugal pumps in practical applications, circuit resistance was a more essential factor than flow-pressure curves of the pump.

  2. Safety of human blood products: inactivation of retroviruses by heat treatment at 60 degrees C. (United States)

    Hilfenhaus, J; Mauler, R; Friis, R; Bauer, H


    Acquired immune deficiency syndrome (AIDS) can be transferred to patients by blood transfusions or human blood preparations, such as cryoprecipitates or factor VIII concentrates. Retroviruses have been discussed as infectious AIDS agents and more recently human T-lymphotropic retroviruses designated as HTLV type III and LAV (lymphadenopathy-associated virus) have been isolated from AIDS patients. Whether heat treatment at 60 degrees C (pasteurization) of liquid human plasma protein preparations inactivates retroviruses was therefore investigated. Pasteurization had already been included in the routine manufacturing process of human plasma protein preparations in order to guarantee safety with regard to hepatitis B. Since high titer preparations of human retroviruses were not available, heat inactivation was studied using Rous sarcoma virus added to the various plasma protein preparations tested. This retrovirus which was obtained in preparations of 6.0 log10 FFU/ml was shown to be at least as heat stable as two mammalian retroviruses studied, i.e., feline and simian sarcoma virus. In all of eight different plasma protein preparations tested, Rous sarcoma virus was completely inactivated after a heat treatment lasting no longer than 4 hr. It is thus concluded that pasteurization of liquid plasma protein preparations at 60 degrees C over a period of 10 hr must confer safety to these products with respect to AIDS, provided that the AIDS agents are retroviruses of comparable heat stability as Rous sarcoma virus and the mammalian retroviruses tested.

  3. Managing blood pressure control in Asian patients: safety and efficacy of losartan. (United States)

    Cheung, Tommy Tsang; Cheung, Bernard Man Yung


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

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

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


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

  5. Quality assurance in the ambulatory care setting. (United States)

    Tyler, R D


    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.

  6. 30 CFR 15.8 - Quality assurance. (United States)


    ... 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...

  7. 30 CFR 7.7 - Quality assurance. (United States)


    ... 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. Quality Assurance: One School's Response. (United States)

    Wittemann, K. Joseph


    Since 1987, the Virginia Commonwealth University School of Dentistry has established a system of committee responsibilities for quality assurance, involving the committees for clinical affairs, academic performance, safety and therapeutics, and a council composed largely of department chairs. Additional review of procedures and records management…

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

    Directory of Open Access Journals (Sweden)

    Rolf Burghaus

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

  10. Malaria and blood transfusion: major issues of blood safety in malaria-endemic countries and strategies for mitigating the risk of Plasmodium parasites. (United States)

    Abdullah, Saleh; Karunamoorthi, Kaliyaperumal


    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

  11. Comparing efficacy and safety of 2 methods of tranexamic acid administration in reducing blood loss following total knee arthroplasty (United States)

    Fu, Yu; Shi, Zhigang; Han, Bing; Ye, Yong; You, Tao; Jing, Juehua; Li, Jun


    Abstract Background: The purpose of this systematic review and meta-analysis of randomized controlled trials (RCTs) were to gather data to evaluate the efficacy and safety of topical tranexamic acid (TXA) versus intravenous (IV) TXA for blood loss after a total knee arthroplasty (TKA). Methods: Electronic databases: Pubmed, Web of Science, Cochrane library, and Embase from inception to June 2016 were searched. RCTs that comparing topical with IV TXA for blood loss control in patients prepared for TKA were included in this meta-analysis. The Cochrane risk of bias tool was used to appraise risk of bias. The primary outcomes were needed for transfusion, total blood loss, and blood loss in drainage. Secondary outcomes are hemoglobin (Hb) value at 24-hour post TKA and complication (deep venous thrombosis [DVT] and infection). The efficacy of blood loss was tested by total blood loss, drainage volume, Hb drop, and the Hb value at 24 hours after TKA. The safety was measured by the occurrence of DVT and infection. Continuous outcomes were expressed as the mean difference with the respective 95% confidence intervals (CIs). Discontinuous outcomes were expressed as the relative risk with 95% CIs. Stata 12.0 software (Stata Corp., College Station, TX) was used for the meta-analysis. Results: A total of 14 articles involving 1390 patients were finally included for this meta-analysis. The pooled results revealed that there were no significant difference between the need for transfusion, total blood loss, blood loss in drainage, Hb value at 24-hour post TKA, the occurrence of complications (infection and DVT) between topical administration of TXA and IV TXA. Conclusion: Topical TXA has similar efficacy for blood loss control to IV TXA without sacrificing safety in TKA. However, the dose of topical TXA and IV TXA is different, thus, optimal timing and dose of TXA are still needed to explore the maximum effect of TXA. PMID:27977593

  12. SAFETY

    CERN Multimedia

    Niels Dupont


    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...

  13. 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


    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 number NCT01267734.

  14. Safety

    CERN Multimedia


    Please note that the safety codes A9, A10 AND A11 (ex annexes of SAPOCO/42) entitled respectively "Safety responsibilities in the divisions" "The safety policy committee (SAPOCO) and safety officers' committees" and "Administrative procedure following a serious accident or incident" are available on the web at the following URLs: Code A9: Code A10: Code A11: Paper copies can also be obtained from the TIS divisional secretariat, e-mail: TIS Secretariat

  15. Safety and Feasibility of Achieving Lower Systolic Blood Pressure Goals in Persons With Type 2 Diabetes: The SANDS Trial (United States)

    Weir, Matthew R.; Yeh, Fawn; Silverman, Angela; Devereux, Richard B.; Galloway, James M.; Henderson, Jeffrey A.; Howard, William J.; Russell, Marie; Wilson, Charlton; Ratner, Robert; Sorkin, John; Umans, Jason; Fleg, Jerome L.; Stylianou, Mario; Lee, Elisa; Howard, Barbara V.


    The Stop Atherosclerosis in Native Diabetics Study (SANDS) was a randomized open-label clinical trial in type 2 diabetics designed to examine the effects of intensive reduction of blood pressure, aggressive vs standard goals (≤115 / 75 mm Hg vs ≤130 / 80 mm Hg), and low-density lipoprotein (LDL) cholesterol on the composite outcome of change in carotid intimal-medial thickness and cardiovascular events. The study demonstrated that in conjunction with a lower LDL cholesterol target of 70 mg/ dL, aggressive systolic blood pressure–lowering resulted in a reduction in carotid intimal-medial thickness and left ventricular mass without measurable differences in cardiovascular events. The blood pressure treatment algorithm included renin-angiotensin system blockade, with other agents added if necessary. The authors conclude that both standard and more aggressive systolic blood pressure reduction can be achieved with excellent safety and good tolerability in patients with type 2 diabetes mellitus. PMID:19817934

  16. Quality Assurance - Construction

    DEFF Research Database (Denmark)

    Gaarslev, Axel


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

  17. 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


    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.

  18. Redefining and expanding quality assurance. (United States)

    Robins, J L


    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.

  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.


    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 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)



    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

  1. Blood gas and patient safety: considerations based on experience developed in accordance with the Risk Management perspective. (United States)

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


    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.

  2. The first results demonstrating efficiency and safety of a double-column whole blood method of LDL-apheresis. (United States)

    Hequet, O; Le, Q H; Rigal, D; Mekhloufi, F; Jaeger, S; Sassolas, A; Groisne, L; Moulin, P


    LDL-apheresis is a treatment for familial hypercholesterolemia in addition to diet and drug therapy. In the past, LDL-apheresis techniques consisted in separating plasma from blood and adsorbing plasma LDL-C whereas recent methods remove LDL-C directly from whole blood. The whole blood system developed by Kaneka consists of a single-column (Liposorber DL-75) treatment (SCWB) but a double-column whole blood (DCWB) method has recently been developed (Liposorber DL-50 x 2). When 1.6 blood volumes (plus 1l) were processed, acute reductions of total cholesterol and LDL-C were 67.9+/-6% and 80.2+/-4.5%, respectively. The performances of the DCWB method were compared to other LDL-apheresis methods. Assessed in 10 patients, the DCWB method is more efficient than the SCWB method with higher reduction rates of LDL-C (79.7+/-4.9 vs. 68.2+/-5.0% papheresis method consisting of preliminary plasma separation followed by plasma LDL-C adsorption and used as first line apheresis therapy (80.5+/-4.5 vs. 79.0+/-5.9%). The safety of DCWB was demonstrated in 12 patients with only a low frequency of mild and transient adverse effects (4%). In conclusion, the DCWB LDL-apheresis method provides efficient removal of LDL-C, a low level of adverse effects, and a shortened duration of the procedure.

  3. Multinational Quality Assurance (United States)

    Kinser, Kevin


    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…

  4. Role of National Accreditation Board of Hospitals and Healthcare Providers (NABH core indicators monitoring in quality and safety of blood transfusion

    Directory of Open Access Journals (Sweden)

    Anshu Gupta


    Full Text Available Context: Certain quality indicators are mandatory in the maintenance and improvement of quality in blood transfusion. Monitoring of such indicators should be done regularly and deficiencies are to be corrected for effective blood transfusion services. Aims: To study the usefulness of monitoring of the National Accreditation Board for Hospitals and Healthcare Providers (NABH core indicators in blood transfusion and in the maintenance of hemovigilance. Settings and Design: Hemovigilance is a "quality process" to improve quality and increase the safety of blood transfusion. It covers and surveys all activities of the blood transfusion chain from donors to recipients. Core indicators′ monitoring is a part of the hemovigilance process. Materials and Methods: A 2-year retrospective study was conducted in a blood storage unit of a NABH accredited tertiary care hospital of a metropolitan city. Four NABH core indicators in blood transfusion were observed and monitored by the clinical and blood storage unit staff of different levels. Results: It was observed that there was an improvement in quality by core indicators monitoring with decreased wastage of blood and blood components, decreased average turnaround time for issue of blood and blood components, and lesser number of transfusion reactions. Conclusion: This study demonstrated that monitoring of NABH core indicators results in the enhancement of quality and safety in blood transfusion services, reducing the incidence of transfusion reactions.

  5. Blood (United States)

    ... Also, blood is either Rh-positive or Rh-negative. So if you have type A blood, it's either A positive or A negative. Which type you are is important if you need a blood transfusion. And your Rh factor could be important ...

  6. Real-time blood cross-matching sensor for intelligent management of transfusion safety. (United States)

    Ramasubramanian, M K; Anthony, Steven R


    Blood transfusion errors are not uncommon. In some cases the error is fatal. This is primarily due to lack of an automated system at the point of application and over-reliance on bar-coding and paperwork to catch these critical errors. In emergency situations, human errors contribute to transfusion and transplantation of incompatible blood types and organs resulting in rejection and possible fatality. We present a sensing concept that will monitor blood compatibility between the patient and the transfusion bag before allowing the valve to open for transfusion to take place. This will eliminate all transfusion errors and provide 100% safe transfusions automatically. The operating principle of the sensor is based on the light scattering characteristics of dilute blood and the effect of agglutination on scattering. The device proposed is an optical system based on spectrophotometric methods. The device configuration, and results from several tests with combinations of known blood samples will be presented.

  7. Insight into "Calculated Risk": An Application to the Prioritization of Emerging Infectious Diseases for Blood Transfusion Safety. (United States)

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


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

  8. Efficacy and Safety of Frozen Blood for Transfusion in Trauma Patients - A Multi-Center Trial (United States)


    shown to be a major risk factor for post-injury multiple organ failure [24,26,27,29,46,47]. Koch et al. found associations between age of blood...of stay, acute respiratory distress syndrome, acute renal failure, transfusion reaction, deep venous thrombosis , and mortality) were recorded. Acute...Blackwell J, Ciesla DJ, et al. Age of transfused blood is an independent risk factor for postinjury multiple organ failure. Am J Surg. 1999; 178(6):570

  9. 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


    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.

  10. SAFETY

    CERN Multimedia

    M. Plagge, C. Schaefer and N. Dupont


    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...

  11. SAFETY

    CERN Multimedia

    C. Schaefer and N. Dupont


      “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...

  12. [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]. (United States)

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


    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.

  13. Individualized conditioning regimes in cord blood transplantation : Towards improved and predictable safety and efficacy

    NARCIS (Netherlands)

    Admiraal, R; Boelens, J J


    INTRODUCTION: The conditioning regimen used in cord blood transplantation (CBT) may significantly impact the outcomes. Variable pharmacokinetics (PK) of drugs used may further influence outcome. Individualized dosing takes inter-patient differences in PK into account, tailoring drug dose for each in

  14. Development and implementation challenges of a quality assured HIV infant diagnosis program in Nigeria using dried blood spots and DNA polymerase chain reaction. (United States)

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


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

  15. High assurance services computing

    CERN Document Server


    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

  16. Building Assured Systems Framework (United States)


    Extraction (FX) Techniques to Reverse Engineer Virtual Machines Mark Pleszkoch, Stacy Prowell, Cory F. Cohen, and Jeffrey S. Havrilla 6.3 Assured...Cory F. Cohen and Jeffrey S. Havrilla 5.1.2 Potential attack methods, 5.2.1 Historic and potential operational attack methods, 6.3 Assured

  17. Towards Run-time Assurance of Advanced Propulsion Algorithms (United States)

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


    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.

  18. 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)


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

  19. [Jean-Jacques Lefrère: A miscarried ambition for blood safety in francophone Africa]. (United States)

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


    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.

  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


    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. Quality Control of the Key Link of Safety Management of Blood%血液安全管理关键环节质量控制

    Institute of Scientific and Technical Information of China (English)



    输血是临床抢救和治疗病人不可缺少的重要手段,同时输血安全也日益受到重视,已成为一个重要的公共安全问题。加强血液安全管理,保证输血安全关键环节包括:科学判断献血者资格,严格血液采集;加强实验室管理,构建血液检测安全屏障;建立疫情报告制度,屏蔽不合格献血者;严格成分血液制备,确保贮存运输条件;科学评估输血指征,合理有效输血;做好输血前检查,保证输血安全有效;核对输血相关信息,填写输血记录。影响输血安全的因素很多,关键因素是“人”,只有牢固树立血液质量理念,建立输血质量管理体系,人人牢记质量,个个关注质量,不断完善血液从采集到输注(即血管到血管)整个流程的质量管理,血站和临床紧密结合,环环相扣,树立输血存在风险意识,科学合理用血,提高输血技术水平,才能保障临床用血安全有效。%Blood transfusion is an important means for clinical treatment and patients indispensable, and blood transfusion safety has received increasing attention, has become an important issue of public safety. strengthen the blood safety management, ensure the safety of blood transfusion: including key scientific judgment donors qualification, strict blood collection; strengthen the management of the laboratory, construction of blood safety barrier; establish the epidemic reporting system, shielding the unqualified blood donors; strict blood component preparation, ensure storage and transportation conditions;scientific evaluation of the indications for transfusion, reasonable and effective blood transfusion; do the examination before the blood transfusion, ensure blood transfusion is safe and effective; check the transfusion related information, fill in the record of the transfusion. Many factors influence the safety of blood transfusion, the key factor is "people", only to

  2. Occupational safety during the remediation of a contaminated site: monitoring of PCDD/PCDF levels in blood of employees

    Energy Technology Data Exchange (ETDEWEB)

    Rottler, H. [Eurofins Oekometric, Bayreuth (Germany); Uffinger, H. [Tiefbau-Berufsgenossenschaft (TBG), Arbeitsmedizinischer Dienst, Frankfurt/Main (Germany)


    In connection with road construction activities a dioxin contaminated site was discovered during the 1990's in a German city, containing residues of early industrial activities. PCDD/PCDF levels up to 41 ng I-TEQ/g dry matter could be detected in the material with a 1,2,3,4,7,8-HxCDF dominated pattern. This pattern is very similar to samples related to the production and use of chlorine in the early 20{sup th} century. Furthermore, sandy material showing a deviating and 1,2,3,7,8-PeCDF dominated pattern with an at least a factor of 10 lower concentrations was found. A remediation program was initiated including removal of contaminated soil and installing a drainage layer below the final asphalt layer sealing the site. Occupational safety for employees involved in any on-site activities was of primary importance following regulations for work in contaminated areas and for preventive occupational medicine. Hygiene was strictly obeyed. On-site monitoring via chromatographic dust analysis was performed by surveying engineers. Employees working in contaminated areas wore Air-Filters A2P3 with motor support. The mandatory personal safety equipment included dust-proof protective suits for single use, chemical-proof gloves and boots. In this context, it was the task of the Employer's Liability Insurance Association (Tiefbau- Berufsgenossenschaft, TBG) to strictly control compliance of occupational safety measures. The occupational medical service of this association was commissioned monitoring the health situation of the employees involved. Among other parameters, the corresponding control program included monitoring of PCDD/PCDF blood levels to identify possible alterations.

  3. Model Based Mission Assurance: Emerging Opportunities for Robotic Systems (United States)

    Evans, John W.; DiVenti, Tony


    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).

  4. The Blood Quality Monitoring Network System's Role in the Safety of Blood Transfusion%血液质量监测网络体系在输血安全中的作用

    Institute of Scientific and Technical Information of China (English)

    胡秀兰; 田志彬; 李忠杰; 玄红霞; 陈书芳


    目的探寻建立血站血液质量监测网络体系,确保血液质量与安全。方法对献血者献血前的血液标本进行初筛,对采血场所、关键原辅材料、关键设备进行质量控制,同时加强采后血液的质量监测以及各供血库的监测。结果比较质量监测网络体系建立前后血液质量情况,发现血液质量监测网络体系建立后血液质量有明显提高。结论建立完整有效、安全的血液质量监测网络体系,对血液的采集、检验、保存、运送和使用等多个环节进行血液质量监测,监控血液"从血管到血管"的全过程,确保献血者、用血者身体健康和生命安全。%Objective To explore the establishment of a blood bank blood quality monitoring network system to ensure the quality and safety of blood. Methods for screening blood donors before blood samples, blood col ection establishments, the key raw materials, key equipment for quality control quality, while strengthening the postharvest quality monitoring of blood as wel as monitoring for blood banks. Results the comparative quality monitoring network system to establish the quality of blood before and after situation, significantly improved blood quality monitoring network system to establish the quality of blood. Conclusions to establish a complete and ef ective, safe blood quality monitoring network system for blood col ection, testing, preservation, transportation and use of other aspects of the blood quality monitoring, monitoring of blood"from the blood vessels to the blood vessels,"the whole process to ensure donors with blood by the health and safety of life.

  5. Software quality assurance handbook

    Energy Technology Data Exchange (ETDEWEB)


    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.

  6. General safety considerations

    Energy Technology Data Exchange (ETDEWEB)



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

  7. General safety considerations

    Energy Technology Data Exchange (ETDEWEB)



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

  8. Safety Validation of Repeated Blood-Brain Barrier Disruption Using Focused Ultrasound. (United States)

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


    The purpose of this study was to investigate the effects on the brain of multiple sessions of blood-brain barrier (BBB) disruption using focused ultrasound (FUS) in combination with micro-bubbles over a range of acoustic exposure levels. Six weekly sessions of FUS, using acoustical pressures between 0.66 and 0.80 MPa, were performed under magnetic resonance guidance. The success and degree of BBB disruption was estimated by signal enhancement of post-contrast T1-weighted imaging of the treated area. Histopathological analysis was performed after the last treatment. The consequences of repeated BBB disruption varied from no indications of vascular damage to signs of micro-hemorrhages, macrophage infiltration, micro-scar formations and cystic cavities. The signal enhancement on the contrast-enhanced T1-weighted imaging had limited value for predicting small-vessel damage. T2-weighted imaging corresponded well with the effects on histopathology and could be used to study treatment effects over time. This study demonstrates that repeated BBB disruption by FUS can be performed with no or limited damage to the brain tissue.

  9. RAVEN Quality Assurance Activities

    Energy Technology Data Exchange (ETDEWEB)

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


    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.

  10. Performance assurance program plan

    Energy Technology Data Exchange (ETDEWEB)

    Rogers, B.H.


    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.

  11. Requirements for blood and blood components intended for transfusion or for further manufacturing use. Final rule. (United States)


    The Food and Drug Administration (FDA) is amending the regulations applicable to blood and blood components, including Source Plasma, to make the donor eligibility and testing requirements more consistent with current practices in the blood industry, to more closely align the regulations with current FDA recommendations, and to provide flexibility to accommodate advancing technology. In order to better assure the safety of the nation's blood supply and to help protect donor health, FDA is revising the requirements for blood establishments to test donors for infectious disease, and to determine that donors are eligible to donate and that donations are suitable for transfusion or further manufacture. FDA is also requiring establishments to evaluate donors for factors that may adversely affect the safety, purity, and potency of blood and blood components or the health of a donor during the donation process. Accordingly, these regulations establish requirements for donor education, donor history, and donor testing. These regulations also implement a flexible framework to help both FDA and industry to more effectively respond to new or emerging infectious agents that may affect blood product safety.

  12. Quality assurance and product quality

    Energy Technology Data Exchange (ETDEWEB)

    Lacroix, D.; Bastiani, P. de [COGEMA Logistics (AREVA Group) (France)


    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.

  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


    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


    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. Vega flow assurance system

    Energy Technology Data Exchange (ETDEWEB)

    Larsen, Marit; Munaweera, Sampath


    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)

  16. Formal Assurance Arguments: A Solution In Search of a Problem? (United States)

    Graydon, Patrick J.


    An assurance case comprises evidence and argument showing how that evidence supports assurance claims (e.g., about safety or security). It is unsurprising that some computer scientists have proposed formalizing assurance arguments: most associate formality with rigor. But while engineers can sometimes prove that source code refines a formal specification, it is not clear that formalization will improve assurance arguments or that this benefit is worth its cost. For example, formalization might reduce the benefits of argumentation by limiting the audience to people who can read formal logic. In this paper, we present (1) a systematic survey of the literature surrounding formal assurance arguments, (2) an analysis of errors that formalism can help to eliminate, (3) a discussion of existing evidence, and (4) suggestions for experimental work to definitively answer the question.

  17. Benchmarking Software Assurance Implementation (United States)


    product The chicken#. (a.k.a. Process Focused Assessment ) – Management Systems ( ISO 9001 , ISO 27001, ISO 2000) – Capability Maturity Models (CMMI...Assurance PRM, RMM, Assurance for CMMI)) – Lifecycle Processes ( ISO /IEEE 15288, ISO /IEEE 12207) – COBIT, ITIL, MS SDL, OSAMM, BSIMM 5 The egg...a.k.a Product Focused Assessments) – SCAP - NIST-SCAP – ISO /OMG W3C – KDM, BPMN, RIF, XMI, RDF – OWASP Top 10 – SANS TOP 25 – Secure Code Check Lists

  18. Just in Time Assurance (United States)


    Just in Time Assurance Ji Al F PhD U i it f Id hm ves- oss, , n vers y o a o Director Center for Secure and Dependable Computing W. Mark Vanfleet...COVERED 00-00-2010 to 00-00-2010 4. TITLE AND SUBTITLE Just in Time Assurance 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6...discusses how practical and affordable recertification can become the norm instead of the rare exception 2 What Does Just in Time Mean? Manufacturing

  19. The limits of sterility assurance. (United States)

    von Woedtke, Thomas; Kramer, Axel


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

  20. Mission Operations Assurance (United States)

    Faris, Grant


    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.

  1. [The francophone Africa blood transfusion research network: a five-year report]. (United States)

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


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

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


    Meng Wang; Xin-Feng Zheng; Lei-Sheng Jiang


    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...

  3. 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


    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.

  4. BYU Food Quality Assurance Laboratory (United States)

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

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

    DEFF Research Database (Denmark)

    Kristoffersen, Dorte; Lindeberg, Tobias


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

  6. [Medical quality assurance today]. (United States)

    Schäfer, Robert D


    Both the quality and performance of health systems are strongly influenced by the number and the qualification of the professional staff. Quality assurance programs help to analyse causalities which are responsible for medical malpractice. On the basis of the experiences gained by the performance of established Quality Assurance Programs (QAP) in the North Rhine area since 1982 various aspects of the efficiency of these programs will be discussed. The implementation of legal regulations making these programs mandatory is criticised not only for its bureaucratic effect but also for the attempt to exclude professional experts from the interpretation of results. It is recommended to liberalize these regulations in order to facilitate improvement of methods and participation of the medical profession.

  7. Power transformers quality assurance

    CERN Document Server

    Dasgupta, Indrajit


    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

  8. 医院输血科生物安全管理现状及对策%Current management of biological safety in hospital blood transfusion and countermeasures

    Institute of Scientific and Technical Information of China (English)

    吴争胜; 蒋璐茜; 陈秉宇


    目的 根据浙江省输血科(血库)生物安全建设的现状,探讨进行规范化管理的方法. 方法 随机调查浙江省30所医院输血科(血库)存在的生物安全隐患,探讨制定切实可行的管理措施. 结果 综合性医院输血科生物安全管理方面存在诸多隐患,其中管理制度、操作规程等完善的合格率仅60.0%,66.7%输血科工作区布局不够合理、工作人员感染防范意识较差、医疗废弃物处理不规范等,个人防护的基本配置>90.0%,但实际使用率欠佳. 结论 必须严格执行生物安全的法律法规,制定和健全规章制度,才能确保输血科生物安全,有效预防与控制医院感染.%OBJECTIVE To approach standardized management of biological safety in blood transfusion based upon the present situation in this field in Zhejiang.METHODS A randomized survey of hidden hazardous factors threatening biological safety was conducted among the departments of blood transfusion in 30 hospitals and the data were statistically analyzed.RESULTS Several risky issues were found in the management of blood transfusion and biological safety.The qualified rate of supervising system and operating rules was only 60.0 %, unreasonable layout of workspace, poor awareness of prevention of infection, inadequate disposition of medical wastes accounted for 66.7%, staff's body sheltering was equipped over 90.0%, but the actual using rate was unexpectedly low.CONCLUSION In order to ensure the biological safety in blood transfusion and effective prevention and control of hospital infection, the relevant laws and regulations concerning biological safety should be established and strictly carried out.

  9. 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


    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.

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

    Energy Technology Data Exchange (ETDEWEB)

    Rolle, A.; Buhlemann, L. [Bundesanstalt fuer Materialforschung und -pruefung (BAM), Berlin (Germany)


    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.

  11. Era of blood component therapy: time for mandatory pre-donation platelet count for maximizing donor safety and optimizing quality of platelets. (United States)

    Das, Sudipta Sekhar; Zaman, R U; Biswas, Dipak


    Blood bank regulatory agencies including the Drug and Cosmetics Act (DCA) of India do not mandate a predonation platelet count in whole blood donation. Mandating such practice will definitely optimize the quality of random donor platelets (RDP) in terms of platelet yield and patient therapeutic benefit. We observed poor platelet yield in RDP concentrates prepared at our center with a significant number not meeting the DCA guideline of ≥ 4.5 × 10(10) per bag processed from 450 ml of whole blood. Therefore we planned this study to evaluate the pre-donation hematological values in our blood donor population and effect of these values on the quality of platelet concentrates. The prospective study included 221 blood donors eligible for donating 450 ml of whole blood (WB). Following the departmental standard operating procedure (SOP) RDPs were prepared using the 'Top & Bottom' quadruple bag system and automated component extractor. Quality of RDP was assessed as per departmental protocol. All results were recorded and subsequently transcribed to SPSS working sheet. A significant (pblood counts has been observed after WB donation. Mean donor Hb and platelets reduced by 0.72 g/dl and 22.1 × 10(6)/ml respectively. Quality of RDPs in terms of platelet yield was significantly better (pcount was >200 × 10(6)/ml. Although platelet yield significantly correlated with the donor platelet count however quality of RDPs in terms of red cell contamination showed no correlation with the donor hematocrit. Platelet yield in random donor platelets is a concern in Eastern India. A platelet yield of 4.5 × 10(10) per bag as mandated by the DCA of India was only achieved when the donor platelet count was >200 × 10(6)/ml. Posttransfusion platelet recovery (PPR) was unsatisfactory in the transfused patient. Introduction of pre-donation platelet count in whole blood donation will maximize donor safety and optimize patient platelet transfusion management.

  12. Acquisition of certification on quality assurance system ISO9002 in the Tokai Reprocessing Center

    Energy Technology Data Exchange (ETDEWEB)

    Masui, Jinichi; Kobayashi, Kentaro; Iwasaki, Shogo; Fukanoki, Shinji [Japan Nuclear Cycle Development Inst., Tokai Works, Tokai Reprocessing Center, Tokai, Ibaraki (Japan)


    On September 6th 2001, Tokai Reprocessing Center obtained Certification under Quality Assurance System ISO9002: 2nd edition 1994 (JIS Z9902: 1998)-Model for quality assurance in production, installation and servicing. In Tokai Reprocessing Plant, quality assurance activities have been undertaken to contribute to the safety and stable operation of the plant based on the JEAG4101 since 1983. Since 1995, the establishment of a quality assurance system based on the ISO9000 series has been underway, and with the fire and explosion incident at the Bituminization Demonstration Facility as a turning point, this activity has been accelerated and certification obtained under ISO9002. These procedures have strengthened quality assurance activities in the plant operation and transparency of the business has been improved for society through an objective evaluation conducted by the International Organization for Standardization. This report describes the details of quality assurance activities until the acquisition of certification and the outline of the established quality assurance system. (author)

  13. Patient safety: Safety culture and patient safety ethics

    DEFF Research Database (Denmark)

    Madsen, Marlene Dyrløv


    and interviews with staff and management in four hospital departments. The appendix contains the Patient Safety Culture Questionnaire tool that I have developed, tested and revised for use in theDanish hospital setting based on the research projects on safety culture described in papers 3, 4 and 5. Paper 6......Patient safety - the prevention of medical error and adverse events - and the initiative of developing safety cultures to assure patients from harm have become one of the central concerns in quality improvement in healthcare both nationally andinternationally. This subject raises numerous...... the problems, and suggest possible solutions for improving patient safety through the promotion of safety culture and ethics. I seek to illuminate theissues of patient safety from several perspectives; the organizational healthcare system, in particular the healthcare workers perspectives and experiences...

  14. Microsurgical versus endovascular interventions for blood-blister aneurysms of the internal carotid artery: systematic review of literature and meta-analysis on safety and efficacy. (United States)

    Shah, Sumedh S; Gersey, Zachary C; Nuh, Mohamed; Ghonim, Hesham T; Elhammady, Mohamed Samy; Peterson, Eric C


    OBJECTIVE Blood-blister aneurysms (BBAs) of the internal carotid artery (ICA) have a poor natural history associated with high morbidity and mortality. Currently, both surgical and endovascular techniques are employed to treat BBAs; thus, the authors sought to perform a meta-analysis to compare the efficacy and safety of these approaches. METHODS A literature search of PubMed, MEDLINE, and Google Scholar online databases was performed to include pertinent English-language studies from 2005 to 2015 that discussed the efficacy and safety of either surgical or endovascular therapies to treat BBAs. RESULTS Thirty-six papers describing 256 patients with BBAs treated endovascularly (122 procedures) or surgically (139 procedures) were examined for data related to therapeutic efficacy and safety. Pooled analysis of 9 papers demonstrated immediate and late (mean 20.9 months) aneurysm occlusion rates of 88.9% (95% CI 77.6%-94.8%) and 88.4% (95% CI 76.7%-94.6%), respectively, in surgically treated patients. Pooled analysis of 12 papers revealed immediate and late aneurysm obliteration rates of 63.9% (95% CI 52.3%-74.1%) and 75.9% (95% CI 65.9%-83.7%), respectively, in endovascularly treated aneurysms. Procedure-related complications and overall poor neurological outcomes were slightly greater in the surgically treated cases than in the endovascularly treated cases (27.8% [95% CI 19.6%-37.8%] vs 26.2% [95% CI 18.4%-35.8%]), indicating that endovascular therapy may provide better outcomes. CONCLUSIONS Blood-blister aneurysms are rare, challenging lesions with a poor prognosis. Although surgical management potentially offers superior aneurysm obliteration rates immediately after treatment and at the long-term follow-up, endovascular therapy may have a better safety profile and provide better functional outcomes than surgery. A registry of patients treated for BBAs may be warranted to better document the natural course of the disease as well as treatment outcomes.

  15. 16 CFR 1101.32 - Reasonable steps to assure information is accurate. (United States)


    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Reasonable steps to assure information is accurate. 1101.32 Section 1101.32 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INFORMATION DISCLOSURE UNDER SECTION 6(b) OF THE CONSUMER PRODUCT SAFETY ACT Reasonable Steps Commission Will Take...

  16. 16 CFR 1101.33 - Reasonable steps to assure information release is fair in the circumstances. (United States)


    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Reasonable steps to assure information release is fair in the circumstances. 1101.33 Section 1101.33 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INFORMATION DISCLOSURE UNDER SECTION 6(b) OF THE CONSUMER PRODUCT SAFETY ACT Reasonable...

  17. Tainted blood

    DEFF Research Database (Denmark)

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


    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....

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

    NARCIS (Netherlands)

    O'Dwyer, B.


    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

  19. Determinants for conducting food safety culture research

    NARCIS (Netherlands)

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


    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

  20. FESA Quality Assurance

    CERN Document Server

    CERN. Geneva


    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.

  1. Construction quality assurance report

    Energy Technology Data Exchange (ETDEWEB)

    Roscha, V.


    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.

  2. 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

  3. Recent Trends in Quality Assurance (United States)

    Amaral, Alberto; Rosa, Maria Joao


    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…

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

    Energy Technology Data Exchange (ETDEWEB)



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

  5. A Milestone of Aeromedical Research Contributions to Civil Aviation Safety: The 1000th Report in the CARI/OAM Series (United States)


    of crash dieting , and of blood donations in conjunction with simulated altitude exposures. Vision: A Major Research Issue Studies from the research...attitudes and of perceived stress. Data obtained included ambulatory electrocardiograms (ECGs), urine samples analyzed for 17- ketogenic steroids...ratios for potential development of radiation-induced cancers continue to be calculated to assure travelers and flight crews of the safety of air

  6. State Safety Programme and State Safety Plan - Part one – State Safety Programme structure

    Directory of Open Access Journals (Sweden)

    Peter Vittek


    Full Text Available State Safety Programme and plan are considered the main instruments in safety management. In that matter, this paper focuses on their description and simultaneously tries to clarify a need and significance of their establishment and implementation within respective state. All elements, defined in ICAO doc. 9859 as State Safety Programme (SSP fundamentals, are separately described. These elements are divided into four groups, further detailed in individual chapters – State Safety Policy and objectives, State Safety Risk management, State safety assurance, State Safety Promotion.

  7. 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


    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

  8. 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:


    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


    Directory of Open Access Journals (Sweden)

    M. Sh. Khubutiya


    Full Text Available 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.

  10. Evaluation and Safety Control Mechanism of Endotoxin Detection in Whole Blood and Blood Components%全血和成分血内毒素检测评估及其安全控制机制的评价

    Institute of Scientific and Technical Information of China (English)

    鲍自谦; 刘怡


    Objective Through dynamic monitoring bacterial endotoxin and cultivating whole blood and blood components,consistence between endotoxin level and bacterial culture results,association between the clinic fever reaction and blood endotoxin were evaluated.Furthermore,the effectiveness of safety control mechanism on bacterium and endotoxin was assessed.Methods From March to April 2009,a total of 300 blood samples of volunteer donors from our blood center were included in this study.Based on the sample varieties,all of these samples were divided into 3 groups:the whole blood group (n=50),suspended red blood cell (RBC) components group (n=150) and platelet (PLT) components group (n=100).Meanwhile 361 healthy donors from the street during January to February 2009,were chosen as a control group,and their endotoxin results would be used as normal reference range.Dynamic turbidity was used as the quantitative detection method of bacterial endotoxin.Endotoxin content in each group was individually detected during their blood preservations.And the endotoxin content results of each group in different blood preservation period and their bacterial cultivating results were analyzed by variance of repeated measurement data.Moreover,the samples from clinical transfusion fever reaction were detected for endotoxin level.Results Normal blood endotoxin reference range from the control group was (0-0.193) EU/mL.PLT suspension group (W=0.635,P =0.0585),and suspended RBC group (W =0.334,P =0.583) had no significant differences in endotoxin concentration of three periods.There were significant differences in endotoxin in whole blood group of three periods (W=0.860,P=0.014).The endotoxin level of whole blood and blood components was (0.005-0.188) EU/mL,and all bacterial cultivating results were negative.Endotoxin concentration in blood samples of transfusion fever reaction was (0.023-0.145) EU/mL.Conclusions While cultivating results of whole blood and blood components were negative

  11. 2007 special equipment safety

    Institute of Scientific and Technical Information of China (English)


    @@ The General Administration of Quality Supervision, Inspection and Quarantine of P.R.China (AQSIQ) issued a notice on May 28, 2007,requiring various locations to rectify their procedures for checking special equipment and hoisting machines for hidden problems. To further clarify and implement responsibility in the safety management of special equipment in enterprises, inspection responsibilities and test organizations related to technical assurance are to be established. Further, quality inspection departments will be supervised by law in order to improve special equipment safety.

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

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


    Objective The aim of this meta-analysis and systematic review is to evaluate the safety and efficacy of Chinese herbal medicine (CHM) for chronic prostatitis (CP) associated with damp-heat and blood-stasis syndromes. Methods An electronic search of 13 databases up to May 2016 was screened to identify randomized controlled trials comparing the safety and efficacy of CHM for the treatment of CP associated with damp-heat and blood-stasis syndromes. Studies reporting on effective rates, adverse events, National Institutes of Health chronic prostatitis symptom index (NIH-CPSI) scores, and symptom index of Chinese medicine for chronic prostatitis (SI-CM) scores as outcomes were included in the analysis. Data were analyzed by fixed- or random-effect models using the Review Manager software. Results Thirteen articles with the modified Jadad score ≥4 were identified. It was found that CHM was superior to placebo in increasing the efficacy (odds ratio: 6.72, 95% confidence interval [CI]: 2.78–9.48, P<0.00001) and reducing the SI-CM scores (standardized mean difference: −1.08, 95% CI: −1.35 to −0.81, P<0.00001). Oral CHMs were significantly more effective than placebo at reducing NIH-CPSI scores, with a mean difference of −1.39 (95% CI: −1.87 to −0.92, P<0.00001). Nevertheless, no significant differences were found between Prostant and placebo (standardized mean difference: −0.23, 95% CI: −0.46 to 0.01, P=0.06). The frequency of adverse events associated with oral CHM was similar to that associated with placebo (risk ratio: 1.36, 95% CI: 0.72–2.55, P=0.34) and less than that associated with Prostant (risk ratio: 1.63, 95% CI: 1.14–2.34, P=0.008). Conclusion Our novel analysis demonstrates that CHM ranks highest in terms of improvement of CP associated with damp-heat and blood-stasis syndromes. While Prostant showed some efficacy in this disorder, it was associated with a smaller reduction in NIH-CPSI scores. In conclusion, CHM monotherapy is safe and

  13. Quality Assurance Training Tracking (QATTS) (United States)

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


    The papr describes how, rather than building "bridges" across centuries, quality assurance (QA) personnel have the opportunity to build bridges across technical disciplines, between public and private organizations, and between different QA groups. As reviewers and auditors of a...

  15. Occupational exposure to blood and body fluids: new postexposure prophylaxis recommendations. United States Occupational Safety and Health Administration. (United States)

    Cuny, E; Carpenter, W M


    Dental health care professionals continue to suffer exposure incidents from instruments contaminated with blood and/or body fluids from patients. Each of these cases requires that a rigid protocol be followed for their evaluation. New information regarding the risk factors for HIV-seroconversion following an exposure incident have been identified. Recent data has demonstrated that a 79 percent reduction in disease transmission may be possible with a new combination drug therapy. The anti-retroviral drugs included in this new regimen are now standard in the management of occupational exposure to HIV. Several factors set dentistry apart from other health care occupations, and these differences appear to have an effect on the risks associated with occupational exposures. This article explores these risk factors and the new recommendations for postexposure care.

  16. Thoughts on Internal and External Quality Assurance (United States)

    Zhang, Jianxin


    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…

  17. 10 CFR 71.37 - Quality assurance. (United States)


    ... 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...

  18. 40 CFR 51.363 - Quality assurance. (United States)


    ... 40 Protection of Environment 2 2010-07-01 2010-07-01 false Quality assurance. 51.363 Section 51... Requirements § 51.363 Quality assurance. An ongoing quality assurance program shall be implemented to discover... impede program performance. The quality assurance and quality control procedures shall be...

  19. 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


    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.

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

    Energy Technology Data Exchange (ETDEWEB)

    Fishler, B


    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.

  1. 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))


    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

  2. Enhancing Transfusion Safety: Nurse’s Role

    Directory of Open Access Journals (Sweden)

    Kyriazi Vasiliki


    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.

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

    Directory of Open Access Journals (Sweden)

    Wang Z


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

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

    Seghatchian, Jerard; Amiral, Jean


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

  5. 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)



    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

  6. Long-Term Safety of Repeated Blood-Brain Barrier Opening via Focused Ultrasound with Microbubbles in Non-Human Primates Performing a Cognitive Task.

    Directory of Open Access Journals (Sweden)

    Matthew E Downs

    Full Text Available Focused Ultrasound (FUS coupled with intravenous administration of microbubbles (MB is a non-invasive technique that has been shown to reliably open (increase the permeability of the blood-brain barrier (BBB in multiple in vivo models including non-human primates (NHP. This procedure has shown promise for clinical and basic science applications, yet the safety and potential neurological effects of long term application in NHP requires further investigation under parameters shown to be efficacious in that species (500 kHz, 200-400 kPa, 4-5 μm MB, 2 minute sonication. In this study, we repeatedly opened the BBB in the caudate and putamen regions of the basal ganglia of 4 NHP using FUS with systemically-administered MB over 4-20 months. We assessed the safety of the FUS with MB procedure using MRI to detect edema or hemorrhaging in the brain. Contrast enhanced T1-weighted MRI sequences showed a 98% success rate for openings in the targeted regions. T2-weighted and SWI sequences indicated a lack edema in the majority of the cases. We investigated potential neurological effects of the FUS with MB procedure through quantitative cognitive testing of' visual, cognitive, motivational, and motor function using a random dot motion task with reward magnitude bias presented on a touchpanel display. Reaction times during the task significantly increased on the day of the FUS with MB procedure. This increase returned to baseline within 4-5 days after the procedure. Visual motion discrimination thresholds were unaffected. Our results indicate FUS with MB can be a safe method for repeated opening of the BBB at the basal ganglia in NHP for up to 20 months without any long-term negative physiological or neurological effects with the parameters used.

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

    Energy Technology Data Exchange (ETDEWEB)

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


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

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

    CERN Document Server

    American Society for Testing and Materials. Philadelphia


    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...

  9. Japan Co-op's Assurance Policy on Food Safety and Its Implications%日本神户生协的食品安全保障策略及启示

    Institute of Scientific and Technical Information of China (English)

    王海航; 缪里英


    Japan Retail Co-operatives(Co-op for short) are cooperative associations to make purchase of daily commodi- ties for their members, also capital contributors, with the aim of improving their members' life in economy and culture. With the development of consumer cooperative movement, Co-op has distinguished itself as distribution business group while keep- ing the characteristics of consumers movement group. A relevant survey conducted by Institute of Co-op Integrated Research shows that good quality, safety of the products and the important position of food in Co-op are what its members trust and expect most. Through a case study of Japan Co-op Kobe, the largest cooperative in Japan and in the world, this article makes an attempt to find out the reason why Co-op enjoys trust and popularity and how it makes its food safe.%生协综合研究所的相关调查显示,生协会员对生协最为信任也最为期待的是产品的质量和安全。通过分析神户生协在食品安全质量方面所采取的严格自主检查制度、上门咨询订货送货制度、直营工厂和物流系统管理、导入生态理念的产直机制等特色食品经营管理策略.得出生协会员的广泛参与是神户生协实现食品“稳定、安全、放心”的关键所在,也是神户生协扎根阪神地区深得消费者信赖和支持的关键所在的结论。

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

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


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

  11. Mission Assurance: Issues and Challenges (United States)


    JFQ), Summer 1995. [9] Alberts , C.J. & Dorofee, A.J., “Mission Assurance Analysis Protocol (MAAP): Assessing Risk in Complex Environments... CAMUS : Automatically Mapping Cyber Assets to Missions and Users,” Proc. of the 2010 Military Communications Conference (MILCOM 2009), 2009. [23

  12. Quality Assurance Program. QAP Workbook. (United States)

    Pelavin Research Inst., Washington, DC.

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

  13. Legacy Management CERCLA Sites. Quality Assurance Project Plan

    Energy Technology Data Exchange (ETDEWEB)

    Riddle, Donna L.


    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

  14. Quality and safety in radiotherapy

    CERN Document Server

    Pawlicki, Todd


    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

  15. Trends in Area of Safety Communications within Industrial Networks

    Directory of Open Access Journals (Sweden)

    Maria Franekova


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

  16. Quality assurance for environmental analytical chemistry: 1980

    Energy Technology Data Exchange (ETDEWEB)

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


    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.

  17. Quality assurance - how to involve the employees

    DEFF Research Database (Denmark)

    Jørgensen, Michael Søgaard


    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....

  18. Blood Types (United States)

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

  19. Safety analysis procedures for PHWR

    Energy Technology Data Exchange (ETDEWEB)

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


    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.

  20. Safety of autologous blood component transfusion during cesarean section in patients with Rh(D)-negative blood group%Rh(D)阴性血型病人剖宫产术中成分式自体输血的安全性

    Institute of Scientific and Technical Information of China (English)

    周春波; 叶松; 严海雅; 张檀; 黄巧波; 陈俊妍; 孙志强


    Objective To investigate the safety of autologous blood component transfusion during cesarean section in patients with Rh (D)-negative blood group.Methods Thirty ASA Ⅰ or Ⅱ patients of Rh (D)-negative blood group, aged 20-35 yr, weighing 50-80 kg, undergoing elective cesarean section, were enrolled in this study.After lactated Ringer' s solution 7 ml/kg was infused, blood was obtained from radial artery at a rate of 60-80ml/min, and blood volume was maintained by simultaneous infusion of 6% hydroxyethyl starch 130/0.4 at the same rate. The collected blood was subjected to two cycles of autologous blood component separation. Blood collecting during each cycle was stopped 15 s after red blood cells were separated. The autologous blood was infused when the blood loss≥20% of blood volume. The autologous blood was infused after suture of the uterus when the blood loss 0.05).脐动脉血pH值、BE和乳酸浓度均在正常范围内.胎儿娩出后1、5 min时Apgar评分分别为(9.0±0.8)、(9.2±0.8)分;术中出血量(405±28)ml,所有病人未输注异体血.结论 Rh(D)阴性血型病人剖宫产术中成分式自体输血的安全性良好.

  1. 40 CFR 31.45 - Quality assurance. (United States)


    ... 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,...

  2. 40 CFR 30.54 - Quality assurance. (United States)


    ... 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...

  3. 40 CFR 194.22 - Quality assurance. (United States)


    ... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Quality assurance. 194.22 Section 194... General Requirements § 194.22 Quality assurance. (a)(1) As soon as practicable after April 9, 1996, the Department shall adhere to a quality assurance program that implements the requirements of ASME...

  4. Solar consumer assurance network briefing book

    Energy Technology Data Exchange (ETDEWEB)

    Connor, Lynda


    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)

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

    Energy Technology Data Exchange (ETDEWEB)

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


    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).

  6. Requirement Assurance: A Verification Process (United States)

    Alexander, Michael G.


    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.

  7. Quality assurance of qualitative analysis

    DEFF Research Database (Denmark)

    Ríos, Ángel; Barceló, Damiá; Buydens, Lutgarde


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

  8. Consistency and proportionality in policy decision-making in blood safety: the case for an all-apheresis platelet supply in Germany. (United States)

    Vamvakas, E C; Hitzler, W E


    Recently, German investigators presented the first mathematical model finding a significant increase in the risk of HIV, HCV, and HBV transmission when pools of 4 whole-blood-derived buffy-coat platelets, rather than 1 single-donor (apheresis) component, are used to provide one platelet dose. Based, in both cases, on mathematical models employing the incidence/window-period method, the relative risk of transmission from pooled versus apheresis platelets (2.2 or 2.75 for HIV, 2.7 or 3.375 for HCV, and 3.2 or 4.0 for HBV, with pools of 4 or 5 concentrates, respectively) is similar to the difference in risk before (versus after) introduction of HIV-1 and HCV RNA screening. The absolute increase in the risk from pools (1 to 2 HIV-, HCV-, or HBV-infectious platelet doses annually) is much smaller than the yield from HIV-1 and HCV RNA screening projected in the 1990s, but it becomes similar to that yield (with up to 88 infectious platelet doses intercepted) when we consider the next transfusion-transmitted pathogen to emerge in the future. Although pathogen reduction (PR) of platelets would eliminate the difference in risk between pooled and apheresis platelets vis-a-vis viral transmission, PR is not ready for implementation because the safety of PR needs to be investigated further. German transfusion guidelines should be revised to indicate the difference in risk associated with pooled versus apheresis platelets, and transition toward an all-apheresis platelet supply should commence. These actions are consistent with and proportionate to the action taken in the 1990s when screening for HIV-1 and HCV RNA was implemented.

  9. European perspectives of food safety. (United States)

    Bánáti, Diána


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

  10. Quality Interaction Between Mission Assurance and Project Team Members (United States)

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


    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.

  11. Organizational Culture and Safety (United States)

    Adams, Catherine A.


    '..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. Medical devices; immunology and microbiology devices; classification of multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures. Final order. (United States)


    The Food and Drug Administration (FDA) is classifying multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

  13. Assuring safety of blasting operations using powder inhibitors

    Energy Technology Data Exchange (ETDEWEB)

    Mullayanov, F.I.; Gumerov, A.G.; Khayrullin, N.N.; Mal' tsev, A.A.; Spiridonov, V.P.


    The essence of the proposed fire protection method consists in inhibiting the hydrocarbon-air zone in which explosive charges are set off by using powder compositions. When inserting charges the danger areas are the ground just above the borehole and when cutting oil pipelines it is the area about the tube space.

  14. Emergency exposure limits: a guide to quality assurance and safety. (United States)

    Woudenberg, F; van der Torn, P


    Emergency exposure limits (EELs) are necessary in disaster prevention, preparation, and repression. Occupational EELs are available for many chemicals, but are of low toxicological adequacy. An animal experimental EEL of high toxicological adequacy available for many irritant chemicals is the concentration causing a 50% decrease in respiratory rate (RD50). The most outstanding EELs for the general population are the emergency response planning guidelines (ERPGs). A theoretical framework for a three-limit system is developed by the European Chemical Industry Ecology and Toxicology Center (ECETOC). ECETOC found over one order of magnitude variation between assessments of several companies. Nine selected EELs were classified in three clusters of increasing degrees of seriousness of health effects. There was little consistency within clusters, making it impossible to combine EELs. It is recommended to develop a toxicologically adequate EEL in an intercontinental context with cooperation of industry and (supra)national regulatory bodies. ERPGs can be taken as a start. The framework developed by ECETOC can be used to improve the limit setting procedure. A 5- to 10-year update should become part of the procedure. Attention should be devoted to the use of expert judgment. The minimal uncertainty in EELs should be expressed by presenting ranges instead of single values.

  15. Radiation Hardness Assurance (RHA) Guideline (United States)

    Campola, Michael J.


    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


    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. Information security assurance lifecycle research

    Institute of Scientific and Technical Information of China (English)

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


    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.

  18. 16 CFR 1101.34 - Reasonable steps to assure information release is “reasonably related to effectuating the... (United States)


    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Reasonable steps to assure information release is âreasonably related to effectuating the purposes of the Actsâ the Commission administers. 1101.34 Section 1101.34 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INFORMATION DISCLOSURE...

  19. Quality Assurance Project Plan for waste tank vapor characterization

    Energy Technology Data Exchange (ETDEWEB)

    Suydam, C.D. Jr.


    This Quality Assurance Project Plan, WHC-SD-WM-QAPP-013, applies to four separate vapor sampling tasks associated with Phases 1 and 2 of the Tank Vapor Issue Resolution Program and support of the Rotary Mode Core Drilling Portable Exhauster Permit. These tasks focus on employee safety concerns and tank ventilation emission control design requirements. Previous characterization efforts and studies are of insufficient accuracy to adequately define the problem. It is believed that the technology and maturity of sampling and analytical methods can be sufficiently developed to allow the characterization of the constituents of the tank vapor space.

  20. Quality assurance in diagnostic ultrasound

    Energy Technology Data Exchange (ETDEWEB)

    Sipilae, Outi, E-mail: [HUS Helsinki Medical Imaging Center, Helsinki University Central Hospital, P.O. Box 340, 00029 HUS (Finland); Mannila, Vilma, E-mail: [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: [HUS Helsinki Medical Imaging Center, Helsinki University Central Hospital, P.O. Box 750, 00029 HUS (Finland)


    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.

  1. Functional safety of health information technology.

    LENUS (Irish Health Repository)

    Chadwick, Liam


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

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

    Directory of Open Access Journals (Sweden)

    Sudipta Sekhar Das


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

  3. Professionalism, Profession and Quality Assurance Practitioners in External Quality Assurance Agencies in Higher Education (United States)

    Cheung, Jordan C. M.


    This article seeks to spark a dialectic discussion on the establishment of a set of professional competencies for quality assurance practitioners who serve in external quality assurance agencies in higher education. Such a need is identified due to the shortage of relevant and sufficient coverage in the quality assurance literature. To…

  4. 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 detect analytical errors by comparing the a priori precision of the analytical results with the actual variability observed among replicates or duplicates. The method relies on the chi-square distribution to detect excess variability and is quite sensitive even for 5-10 results. Interference control...... serves to detect analytical bias by comparing results obtained by two different analytical methods, each relying on a different detection principle and therefore exhibiting different influence from matrix elements; only 5-10 sets of results are required to establish whether a regression line passes...

  5. Blood transfusion exposure in Denmark and Sweden

    DEFF Research Database (Denmark)

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


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

  6. 36 CFR 6.10 - Financial assurance. (United States)


    ... 36 Parks, Forests, and Public Property 1 2010-07-01 2010-07-01 false Financial assurance. 6.10 Section 6.10 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR SOLID WASTE DISPOSAL SITES IN UNITS OF THE NATIONAL PARK SYSTEM § 6.10 Financial assurance. (a) The...

  7. Tool Use Within NASA Software Quality Assurance (United States)

    Shigeta, Denise; Port, Dan; Nikora, Allen P.; Wilf, Joel


    As space mission software systems become larger and more complex, it is increasingly important for the software assurance effort to have the ability to effectively assess both the artifacts produced during software system development and the development process itself. Conceptually, assurance is a straightforward idea - it is the result of activities carried out by an organization independent of the software developers to better inform project management of potential technical and programmatic risks, and thus increase management's confidence in the decisions they ultimately make. In practice, effective assurance for large, complex systems often entails assessing large, complex software artifacts (e.g., requirements specifications, architectural descriptions) as well as substantial amounts of unstructured information (e.g., anomaly reports resulting from testing activities during development). In such an environment, assurance engineers can benefit greatly from appropriate tool support. In order to do so, an assurance organization will need accurate and timely information on the tool support available for various types of assurance activities. In this paper, we investigate the current use of tool support for assurance organizations within NASA, and describe on-going work at JPL for providing assurance organizations with the information about tools they need to use them effectively.

  8. Quality Assurance in Sub-Saharan Africa (United States)

    Materu, Peter; Righetti, Petra


    This article assesses the status and practice of higher education quality assurance in sub-Saharan Africa, focusing on degree-granting tertiary institutions. A main finding is that structured national-level quality assurance processes in African higher education are a very recent phenomenon and that most countries face major capacity constraints.…

  9. 48 CFR 2453.246 - Quality Assurance. (United States)


    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Quality Assurance. 2453.246 Section 2453.246 Federal Acquisition Regulations System DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT CLAUSES AND FORMS FORMS Prescription of Forms 2453.246 Quality Assurance....

  10. Quality Assurance in Chinese Higher Education (United States)

    Li, Yuan


    Quality assurance has been integrated into the fabric of higher education in China, with the issue of quality in higher education--how to evaluate it and how to enhance it--now taking centre stage in Chinese higher education. In the past decade, the development of quality assurance in Chinese higher education has covered a broad spectrum of…

  11. Quality assurance manual: Volume 2, Appendices

    Energy Technology Data Exchange (ETDEWEB)

    Oijala, J.E.


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

  12. Ontario's Quality Assurance Framework: A Critical Response (United States)

    Heap, James


    Ontario's Quality Assurance Framework (QAF) is reviewed and found not to meet all five criteria proposed for a strong quality assurance system focused on student learning. The QAF requires a statement of student learning outcomes and a method and means of assessing those outcomes, but it does not require that data on achievement of intended…

  13. Reinforcing Quality Assurance in Romanian Higher Education

    Directory of Open Access Journals (Sweden)

    Ana-Maria Dima


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

  14. Blood sugar test - blood (United States)

    ... blood glucose level ( hypoglycemia ) may be due to: Hypopituitarism (a pituitary gland disorder) Underactive thyroid gland or ... tonic-clonic seizure Glucagon blood test Glucagonoma Hyperthyroidism Hypopituitarism Hypothyroidism Insulinoma Low blood sugar Multiple endocrine neoplasia ( ...

  15. Efficacy and Safety of WP Series Extracorporeal Blood Tube Used in Blood Purification Therapy%用于血液净化疗法的WP系列体外循环血路管临床应用的有效性及安全性研究

    Institute of Scientific and Technical Information of China (English)

    邹建洲; 滕杰; 陈利明; 方艺; 李荣英; 丁小强


    目的:评价临床应用WP系列体外循环血路管的有效性及安全性.方法:分析临床应用血液透析用和床旁血液滤过用血路管时的血液净化治疗成功情况及患者症状、体征和实验室检查结果变化情况.结果:分别用床旁血液滤过用血路管和血液透析用血路管各治疗10例次,均顺利完成预定时间治疗.所有血路管的外观透明度、光洁度和柔软度均较好.治疗前后患者血白细胞计数、中性粒细胞比例及内毒素水平均无显著变化.在应用血液透析用血路管治疗中,2例患者出现肌肉抽搐,1例出现透析低血压,经对症处理后均好转.未发现其他不良事件.结论:WP系列血路管在血液净化治疗中有较好的可靠性和安全性.%Objective: To evaluate the efficacy and safety of WP series extracorporeal blood tubes in blood purification therapy. Methods: Observational study was used to evaluate the symptoms, signs and the diversification of laboratory data in patients treated by WP series blood tubes. Results: Patients were treated respectively for 10 sessions by hemodialysis blood tube or continuous hemofiltration blood tube. All patients successfully finished the treatment schedule at the end. Transparency. Smoothness and softness of the tested blood tube were very good. White blood cell count, neutrophil percentage and endotoxin level didn't change significantly before and after therapy (P>0.05). During the period of therapy, two patients suffered from muscle cramps and one patient suffered from intradi-alysis hypotension when treated by hemodialysis blood tube. These patients fully recovered after symptomatic treatment. Other adverse events didn't found during the period of study. Conclusions: The efficacy and safety of tested WP series blood tube are very good when used in hemodialysis therapy or continuous hemofiltration therapy.

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

    Directory of Open Access Journals (Sweden)

    Orie Yoshinari


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

  17. [Quality assurance in acupuncture therapy]. (United States)

    Kubiena, G


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

  18. SWiFT Software Quality Assurance Plan.

    Energy Technology Data Exchange (ETDEWEB)

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


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

  19. Introduction: Cybersecurity and Software Assurance Minitrack

    Energy Technology Data Exchange (ETDEWEB)

    Burns, Luanne [JHU Applied Physics Laboratory; George, Richard [JHU Applied Physics Laboratory; Linger, Richard C [ORNL


    Modern society is dependent on software systems of remarkable scope and complexity. Yet methods for assuring their security and functionality have not kept pace. The result is persistent compromises and failures despite best efforts. Cybersecurity methods must work together for situational awareness, attack prevention and detection, threat attribution, minimization of consequences, and attack recovery. Because defective software cannot be secure, assurance technologies must play a central role in cybersecurity approaches. There is increasing recognition of the need for rigorous methods for cybersecurity and software assurance. The goal of this minitrack is to develop science foundations, technologies, and practices that can improve the security and dependability of complex systems.

  20. 影响血液净化护理安全管理因素的分析和应对策略%Analysis and countermeasures of management factors affecting blood purification nursing safety

    Institute of Scientific and Technical Information of China (English)



    Objective:To explore the management factors affecting blood purification nursing safety and countermeasures.Methods:12467 cases with blood purification were selected from January 2013 to December 2013.We analyzed the nursing safety management factors in blood purification.Results:In this group,there were 176 cases of nursing adverse events.The occurence rate was 1.41% .Complications occurred in 75 cases,including hypotension,disequilibrium syndrome,muscle cramps and so on. 39 cases ad anxiety,depression and other negative emotions.34 cases had hemorrhage and hematoma puncture fistula.Treatment of that had not been recorded in 16 cases.12 cases had puncture needle factors.The reason was related to many factors,including not strong responsibility heart of nurses,patient safety management not in place,the violation of operating process,environment and safety accident and so on.Conclusion:Blood purification room should strictly implement the core system and process,strengthen the management,strengthen the professional knowledge and psychological quality training,to ensure the safety of blood purification therapy.%目的:探讨血液净化护理安全管理因素及应对措施。方法:2013年1月-2013年12月收治行血液净化患者,共计12467例次,分析血液净化护理安全管理因素。结果:本组发生176例次护理不良事件,发生率1.41%。低血压、失衡综合征、肌肉痛性痉挛等并发症75例,焦虑、抑郁等不良情绪39例,穿刺内瘘血肿、出血34例,治疗告知未及时记录16例,穿刺针管因素12例。分析原因与护士责任心不强、患者安全管理不到位、违反操作流程、环境安全意外等多种因素有关。结论:血液净化室要严格执行核心制度及操作流程,加强环节管理,加强专科知识及心理素质培训,保证血液净化治疗安全进行。

  1. The use of ozone-treated blood in the therapy of HIV infection and immune disease: a pilot study of safety and efficacy. (United States)

    Garber, G E; Cameron, D W; Hawley-Foss, N; Greenway, D; Shannon, M E


    The use of ozone therapy is reported to be effective in a variety of viral illnesses, including HIV disease. We performed a phase I study of ozone blood treatments in 10 patients in whom no significant toxicity was observed. Three patients with moderate immunodeficiency showed improvement in surrogate markers of HIV-associated immune disease. A phase II controlled and randomized double-blinded study was initiated comparing reinjection of ozone-treated blood, and reinjection of unprocessed blood for 8 weeks, followed by a 4-week observation period. Ozone had no significant effect on hematologic, biochemical or clinical toxicity when compared with placebo. CD4 cell count, interleukin-2, gamma-interferon, beta 2-microglobulin, neopterin and p24 antigen were also unaffected by both treatment arms. In conclusion, ozone therapy does not enhance parameters of immune activation nor does it diminish measureable p24 antigen in HIV-infected individuals.

  2. Implementation Guideline for Maintenance Line Operations Safety Assessment (M-LOSA) and Ramp LOSA (R-LOSA) Programs (United States)


    airlines and Maintenance Repair & Overhaul ( MROs ) communities. 53 Appendix A. Organizational Change Management – Stakeholder Strategy...Maintenance Line Operations Safety Audit MRO – Maintenance, Repair & Overhaul NOSS – Normal Operations Safety Survey QA – Quality Assurance RACI

  3. Prostaglandin E2 Enhances Human Cord Blood Stem Cell Xenotransplants and Shows Long-Term Safety in Preclinical Nonhuman Primate Transplant Models

    NARCIS (Netherlands)

    Goessling, Wolfram; Allen, Robyn S.; Guan, Xiao; Jin, Ping; Uchida, Naoya; Dovey, Michael; Harris, James M.; Metzger, Mark E.; Bonifacino, Aylin C.; Stroncek, David; Stegner, Joseph; Armant, Myriam; Schlaeger, Thorsten; Tisdale, John F.; Zon, Leonard I.; Donahue, Robert E.; North, Trista E.


    Hematopoietic stem cells (HSCs) are used in transplantation therapy to reconstitute the hematopoietic system. Human cord blood (hCB) transplantation has emerged as an attractive alternative treatment option when traditional HSC sources are unavailable; however, the absolute number of hCB HSCE.; tran

  4. Oral Levosimendan Increases Cerebral Blood Flow Velocities in Patients with a History of Stroke or Transient Ischemic Attack: A Pilot Safety Study

    Directory of Open Access Journals (Sweden)

    Matti Kivikko, MD, PhD


    Conclusions: Oral levosimendan increases cerebral blood flow velocities and diminishes NT-pro-BNP levels in patients with earlier ischemic cerebrovascular event. Daily doses up to 1.0 mg were well tolerated, whereas the 2.0 mg dose level induced an increase in ventricular extrasystoles. identifier: NCT00698763.

  5. Customers’ Perception regarding Assurance of Bancassurance Channel

    Directory of Open Access Journals (Sweden)

    Choudhury Mousumi


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

  6. 40 CFR 191.14 - Assurance requirements. (United States)


    ..., HIGH-LEVEL AND TRANSURANIC RADIOACTIVE WASTES Environmental Standards for Disposal § 191.14 Assurance... Commission (see 10 CFR Part 60 for comparable provisions applicable to facilities regulated by the...

  7. Healthy Family 2009: Assuring Healthy Aging (United States)

    ... Navigation Bar Home Current Issue Past Issues Healthy Family 2009 Assuring Healthy Aging Past Issues / Winter 2009 ... for steady, modest loss. Seek emotional support from family and friends. Expect setbacks; forgive yourself. Make physical ...

  8. Customers’ Perception regarding Assurance of Bancassurance Channel


    Choudhury Mousumi; Singh Ranjit


    Bancassurance has evolved as a strong distribution channel in India. Bancassurance means that the insurance company and the bank come together to offer insurance products from the counter of the banks to the bank’s customer. The present study attempts to analyse customers’ perception regarding assurance of bancassurance channel in providing insurance-related services. The study also tries to find out the impact of various demographic variables on customers’ perception regarding assurance of b...

  9. The Evolution of the NASA Commercial Crew Program Mission Assurance Process (United States)

    Canfield, Amy C.


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

  10. Technical Reference Suite Addressing Challenges of Providing Assurance for Fault Management Architectural Design (United States)

    Fitz, Rhonda; Whitman, Gerek


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

  11. They're Here! How to Prepare Your Blood Bank for Inspection. (United States)

    Byrne, Karen M; Frank, Ernest G; Gedman, Lauren A; Ivey, Julie R


    The importance of an inspection ready blood bank cannot be overemphasized. Various agencies perform inspections to ensure that facilities are compliant with federal and state regulations, as well as with standards defined by professional organizations. Inspections may strike fear into the staff members of the organizations being inspected. When a laboratory is in a state of constant readiness, such anxiety is likely to be lessened. Facilities may differ in structure and size and yet be held to the same standards. This article discusses the who, when, and why of laboratory safety inspections. We share helpful information gathered from various resources, including interviews with a quality assurance specialist, a blood bank manager, and an assessor, to help facilities work towards an inspection ready state.

  12. 42 CFR 422.210 - Assurances to CMS. (United States)


    ... 42 Public Health 3 2010-10-01 2010-10-01 false Assurances to CMS. 422.210 Section 422.210 Public...) MEDICARE PROGRAM MEDICARE ADVANTAGE PROGRAM Relationships With Providers § 422.210 Assurances to CMS. (a) Assurances to CMS. Each organization will provide assurance satisfactory to the Secretary that...

  13. Quality assurance in performance assessments

    Energy Technology Data Exchange (ETDEWEB)

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


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

  14. 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


    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.

  15. Quality assurance in non-interventional studies

    Directory of Open Access Journals (Sweden)

    Capan, Müge


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

  16. Preliminary results of quality assurance implementation in interventional cardiology

    Energy Technology Data Exchange (ETDEWEB)

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


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

  17. 42 CFR 457.495 - State assurance of access to care and procedures to assure quality and appropriateness of care. (United States)


    ... 42 Public Health 4 2010-10-01 2010-10-01 false State assurance of access to care and procedures to assure quality and appropriateness of care. 457.495 Section 457.495 Public Health CENTERS FOR MEDICARE... State assurance of access to care and procedures to assure quality and appropriateness of care. A...

  18. [Blood components and good practices in transfusion]. (United States)

    Andreu, Georges


    Each year, more than three millions of blood components are transfused to more than five hundred thousand patients in France. The optimal use of blood components requires that physicians prescribing blood components master the clinical indications of red blood cells concentrates, platelet concentrates and fresh frozen plasma. In addition, physicians in charge of blood component prescription should provide adequate pre- and post-transfusion information to their patients. Compliance of blood components administration in patients with safety guidelines contributes as well to their optimal use. In addition, for each blood component transfused, a proper evaluation of its safety and its efficacy should be done. Finally, a regular evaluation of transfusion practice in hospital services were blood components are used, through audits made in cooperation with their blood component provider, either blood transfusion centre or the hospital blood bank, enables to appreciate the level of compliance with safety and clinical guidelines, and more globally how the transfusion process is mastered.

  19. Seeking legitimacy for new assurance forms: The case of assurance on sustainability reporting

    NARCIS (Netherlands)

    O'Dwyer, B.; Owen, D.; Unerman, J.


    Based on the development of a more refined conception of legitimacy than has been used in prior audit/assurance and sustainability accounting research, this paper analyses how the legitimation processes adopted by sustainability assurance practitioners in a large professional services firm have co-e

  20. Effect of modifying the information and training structure on the occupational safety of health care workers in exposure to blood and body fluids: A quasi-experimental study. (United States)

    Sarbaz, Masoumeh; Kimiafar, Khalil; Taherzadeh, Zhila; Naderi, HamidReza; Eslami, Saeid


    This study was a quasi-experimental design to assess the effect of a Web-based information system on the occupational exposure to blood and body fluids (BBFs) among health care workers (HCWs). The outcome was the number of exposure incidents with BBFs among HCWs in both hospital A (intervention) and hospital B (control). The findings showed that the implementation of the Web-based information system about infection prevention and control in hospital A decreased exposure incidents with BBFs among the HCWs (P < .001).

  1. 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


    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...... and transfusion-related circulatory overload, and acute lung injury) and mortality at 28 days, 6 months and 1 year.The sample size will enable us to detect a 9% absolute difference in 90-day mortality assuming a 45% event rate with a type 1 error rate of 5% and power of 80%. An interim analysis will be performed...

  2. Safety culture

    Energy Technology Data Exchange (ETDEWEB)

    Keen, L.J. [Canadian Nuclear Safety Commission, Ottawa, Ontario (Canada)


    Safety culture has become a topic of increasing interest for industry and regulators as issues are raised on safety problems around the world. The keys to safety culture are organizational effectiveness, effective communications, organizational learning, and a culture that encourages the identification and resolution of safety issues. The necessity of a strong safety culture places an onus on all of us to continually question whether the safety measures already in place are sufficient, and are being applied. (author)

  3. Quality assurance in functional MRI

    DEFF Research Database (Denmark)

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


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

  4. Elements of a nuclear criticality safety program

    Energy Technology Data Exchange (ETDEWEB)

    Hopper, C.M.


    Nuclear criticality safety programs throughout the United States are quite successful, as compared with other safety disciplines, at protecting life and property, especially when regarded as a developing safety function with no historical perspective for the cause and effect of process nuclear criticality accidents before 1943. The programs evolved through self-imposed and regulatory-imposed incentives. They are the products of conscientious individuals, supportive corporations, obliged regulators, and intervenors (political, public, and private). The maturing of nuclear criticality safety programs throughout the United States has been spasmodic, with stability provided by the volunteer standards efforts within the American Nuclear Society. This presentation provides the status, relative to current needs, for nuclear criticality safety program elements that address organization of and assignments for nuclear criticality safety program responsibilities; personnel qualifications; and analytical capabilities for the technical definition of critical, subcritical, safety and operating limits, and program quality assurance.

  5. Assuring Mechanical Integrity of Refinery Equipment Through Global ON-Stream Inspection

    Energy Technology Data Exchange (ETDEWEB)

    John W. Berthold


    The development of global on-stream inspection technology will have a dramatic effect on how refinery operations are managed in the U.S. in the future. Global on-stream inspection will provide assurance of the mechanical integrity of critical plant equipment and will allow refineries to operate more efficiently with less impact on our environment and with an increased margin of safety.

  6. 'Sterility Testing of Blood Components and Advanced Therapy Medicinal Products' (Munich, April 29, 2010) Organized by the DGTI Section 'Safety in Hemotherapy' - Meeting Report. (United States)

    Wagner, Beate; Grabein, Beatrice


    Neither screening method completely detects all clinically relevant bacterial contaminations. The effect of sampling time and volume as well as standardization of the assay applied has also to be taken into account. Therefore, minimizing the risk of contamination during manufacture by measures such as donor selection, skin disinfection, division, and processing within closed systems remains crucial. In this context new concepts in sterility testing, especially with instable advanced therapy medicinal products (ATMPs), are needed as well as reassessment of pathogen inactivation techniques. At present hemovigilance data indicate that shortening the shelf life of platelet concentrates as introduced in Germany 2008 reduced the risk of transfusion-transmitted bacterial infections to the same extent as bacterial screening as done in Canada or the Netherlands. The evolving methodological progress, e.g. by standardizing culture methods or enhancing detection systems, requires careful follow-up in parallel to hemovigilance data in order to ensure optimal bacterial safety in hemotherapy.

  7. 贮存式自体输血在人工髋关节置换术中的安全性研究%Safety of transfusion with stored autologous blood in artificial hip replacement

    Institute of Scientific and Technical Information of China (English)

    周敏; 黄彩鹏


    Objective To evaluate the safety of transfusion with stored autologous blood in in artificial hip replacement. Methods One hundred patients underwent artificial hip replacement surgery from June 2011 to June 2014, among whom 50 cas-es receive stored autologous blood transfusion (test group) and 50 received al ogeneic blood transfusion (control group). Preop-erative and postoperative blood routine, electrolytes, and perioperative recovery were compared between two groups. Results There were no significant changes in blood routine and electrolytes of test group before and after surgery(P>0.05), while in con-trol group the blood routine indicators and blood calcium were lower and blood potassium was higher after surgery than those before surgery (P<0.05 or 0.01). In test group there was 1 case of pneumonia and 1 case of high fever, while in control group there were 3 cases of pneumonia, 5 cases of high fever and 3 cases of urinary tract infection. The length of hospital stay in test group was shorter than that in control group (6.5±1.7d vs 9.8±3.8d, P<0.05). Conclusion Stored autologous blood transfusion is safe, economic and effective with less complications for patients undergoing elective artificial hip replacement.%目的:观察贮存式自体输血在人工髋关节置换术中的临床效果,探讨在人工髋关节置换术中实施贮存式自体输血对患者安全的影响。方法收集采用贮存式自体输血的50例人工髋关节置换术患者为观察组,采用异体输血的50例患者为对照组,观察两组患者手术前后血常规、血电解质及围术期恢复情况。结果观察组患者手术前后血常规、血电解质指标未出现明显变化(P>0.05),其中发生肺炎1例,高热1例,住院时间(6.5±1.7)d。对照组患者手术后血常规指标明显低于手术前,血电解质指标中血钾高于术前,血钙低于术前(P<0.05或0.01),术后出现高热5例,肺炎3例,泌尿

  8. 16 CFR 1028.103 - Assuring compliance with this policy-research conducted or supported by any Federal Department or... (United States)


    ... Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL PROTECTION OF HUMAN SUBJECTS § 1028.103 Assuring... deliberations; and any employment or other relationship between each member and the institution; for example... application or proposal may be returned to the institution. (Approved by the Office of Management and...

  9. Dose Assurance in Radiation Processing Plants

    DEFF Research Database (Denmark)

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


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

  10. Quality assurance and organizational effectiveness in hospitals. (United States)

    Hetherington, R W


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

  11. Assuring quality in high-consequence engineering

    Energy Technology Data Exchange (ETDEWEB)

    Hoover, Marcey L.; Kolb, Rachel R.


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

  12. Medicare: a strategy for quality assurance. (United States)

    Lohr, K N


    This paper has outlined a strategy proposed by an IOM study committee for a quality review and assurance program for Medicare. The committee intended that such a program respond to several major issues, including: the burdens of harm of poor quality of care (poor performance of clinicians in both technical and interpersonal ways, unnecessary and inappropriate services, and lack of needed and appropriate services); difficulties and incentives presented by the organization and financing of healthcare; the state of scientific knowledge; the problems of adversarial, punitive, and burdensome external QA activities and the need to foster successful internal, organization-based QA programs; the adequacy of quality review and assurance methods and tools; and the human and financial resources for quality assurance. In comparison with the existing federal peer review organization program, the IOM's proposed program is intended to focus far more directly on quality assurance, cover all major settings of care, emphasize both a wide range of patient outcomes and the process of care, and have a greatly expanded program evaluation component and greater public oversight and accountability. In laying out the details of such a program, the IOM committee advanced 10 recommendations to support its proposed program. Two of these call for the Secretary of DHHS to support and expand research and educational activities designed to improve the nation's knowledge base and capacity for quality assurance. Finally, the committee emphasized both the extraordinary challenges of quality assurance and the diversity of support for addressing those challenges, noting that patients, providers, and societal agents all have a responsibility in this regard. Building the nation's capacity through additional research and expanded educational efforts is a major cornerstone of the entire enterprise.

  13. Building a global information assurance program

    CERN Document Server

    Curts, Raymond J


    INTRODUCTION TO INFORMATION ASSURANCE (IA)AuthenticationConfidentialityNon-repudiationBASIC CONCEPTSAttributesInformation AttributesPure Information AttributesAttributes Influenced by the SystemSystem AttributesSecurity AttributesInformation System Support Planning PrinciplesThe Bottom Line, RevisitedInformation Assurance (IA)Commercial CapabilitiesSecurityNetwork ViewsRisk ManagementCognitive HierarchyTypes of LogicSummaryRISK, THREAT AND VULNERABILITYOVERVIEW OF SYSTEMS ENGINEERINGA Systems Engineering Case StudyCase Study BackgroundThe MissionThe GoalAn Approach Toward A SolutionCase Tools:

  14. Quality Assurance Source Requirements Traceability Database

    Energy Technology Data Exchange (ETDEWEB)



    At the Yucca Mountain Project the Project Requirements Processing System assists in the management of relationships between regulatory and national/industry standards source criteria, and Quality Assurance Requirements and Description document (DOE/R W-0333P) requirements to create compliance matrices representing respective relationships. The matrices are submitted to the U.S. Nuclear Regulatory Commission to assist in the commission's review, interpretation, and concurrence with the Yucca Mountain Project QA program document. The tool is highly customized to meet the needs of the Office of Civilian Radioactive Waste Management Office of Quality Assurance.

  15. Safety and Reproducibility of a Clinical Trial System Using Induced Blood Stage Plasmodium vivax Infection and Its Potential as a Model to Evaluate Malaria Transmission (United States)

    Elliott, Suzanne; Sekuloski, Silvana; Sikulu, Maggy; Hugo, Leon; Khoury, David; Cromer, Deborah; Davenport, Miles; Sattabongkot, Jetsumon; Ivinson, Karen; Ockenhouse, Christian; McCarthy, James


    Background Interventions to interrupt transmission of malaria from humans to mosquitoes represent an appealing approach to assist malaria elimination. A limitation has been the lack of systems to test the efficacy of such interventions before proceeding to efficacy trials in the field. We have previously demonstrated the feasibility of induced blood stage malaria (IBSM) infection with Plasmodium vivax. In this study, we report further validation of the IBSM model, and its evaluation for assessment of transmission of P. vivax to Anopheles stephensi mosquitoes. Methods Six healthy subjects (three cohorts, n = 2 per cohort) were infected with P. vivax by inoculation with parasitized erythrocytes. Parasite growth was monitored by quantitative PCR, and gametocytemia by quantitative reverse transcriptase PCR (qRT-PCR) for the mRNA pvs25. Parasite multiplication rate (PMR) and size of inoculum were calculated by linear regression. Mosquito transmission studies were undertaken by direct and membrane feeding assays over 3 days prior to commencement of antimalarial treatment, and midguts of blood fed mosquitoes dissected and checked for presence of oocysts after 7–9 days. Results The clinical course and parasitemia were consistent across cohorts, with all subjects developing mild to moderate symptoms of malaria. No serious adverse events were reported. Asymptomatic elevated liver function tests were detected in four of six subjects; these resolved without treatment. Direct feeding of mosquitoes was well tolerated. The estimated PMR was 9.9 fold per cycle. Low prevalence of mosquito infection was observed (1.8%; n = 32/1801) from both direct (4.5%; n = 20/411) and membrane (0.9%; n = 12/1360) feeds. Conclusion The P. vivax IBSM model proved safe and reliable. The clinical course and PMR were reproducible when compared with the previous study using this model. The IBSM model presented in this report shows promise as a system to test transmission-blocking interventions

  16. Right patient, Right blood

    DEFF Research Database (Denmark)

    Selberg, Hanne; Madsen, Trine Stougaard


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

  17. Modifiers for quality assurance in group facilitation

    NARCIS (Netherlands)

    Kolfschoten, G.L.; Grünbacher, P.; Briggs, R.O.


    A key task of a professional facilitator is to assure the quality of the knowledge products created through collaborative effort. To manage the quality of the knowledge a group generates, facilitators attend to, judge, and question the quality of the contributions a group makes, the decisions it mak

  18. Quality Assurance Program: Beginning Teacher Warranty. (United States)

    Barr, Robert D.

    This report discusses the Quality Assurance Program at the OSU/WOSC School of Education, a merged school serving Oregon State University and Western Oregon State College. This major reform in teacher education is designed to bring a high level of accountability to teacher education and is called a "Warranty of First-Year Teachers." If,…

  19. 38 CFR 18.405 - Assurances required. (United States)


    ...) Extent of application to institution or facility. An assurance shall apply to the entire institution or... real property as security for financing construction of new, or improvement of existing, facilities on... information required to ascertain whether the recipient has complied or is complying with the law....

  20. 15 CFR 8b.5 - Assurances required. (United States)


    ... 15 Commerce and Foreign Trade 1 2010-01-01 2010-01-01 false Assurances required. 8b.5 Section 8b.5 Commerce and Foreign Trade Office of the Secretary of Commerce PROHIBITION OF DISCRIMINATION AGAINST THE... otherwise encumber the real property as security to finance construction of new, or improvement of...

  1. Quality Assurance in University Guidance Services (United States)

    Simon, Alexandra


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

  2. 42 CFR 441.352 - State assurances. (United States)


    ... medical assistance with respect to NF, home health, private duty nursing, personal care services, home and... 42 Public Health 4 2010-10-01 2010-10-01 false State assurances. 441.352 Section 441.352 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  3. 42 CFR 93.301 - Institutional assurances. (United States)




    Directory of Open Access Journals (Sweden)

    Zora Arsovski


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

  5. MCNP{trademark} Software Quality Assurance plan

    Energy Technology Data Exchange (ETDEWEB)

    Abhold, H.M.; Hendricks, J.S.


    MCNP is a computer code that models the interaction of radiation with matter. MCNP is developed and maintained by the Transport Methods Group (XTM) of the Los Alamos National Laboratory (LANL). This plan describes the Software Quality Assurance (SQA) program applied to the code. The SQA program is consistent with the requirements of IEEE-730.1 and the guiding principles of ISO 900.

  6. Quality assurance or neo-imperialism

    DEFF Research Database (Denmark)

    Adriansen, Hanne Kirstine; Madsen, Lene Møller


    intention to do the opposite. Hence, we want to address how to make quality assurance can be made without imposing Western epistemologies. We call for an appreciation of different knowledges instead of mainstreaming in the name of internationalisation and globalisation. Capacity building of higher education...

  7. Quality Assurance in Higher Education in Zimbabwe (United States)

    Garwe, Evelyn Chiyevo


    The purpose of this paper is to furnish local and global stakeholders with detailed information regarding the development and current status of quality assurance in the Zimbabwean higher education sector. The study used document analysis, observation and interviews with key informants as sources of data. This paper addresses the dearth of…

  8. From quality assurance to total quality management


    Andreea Ionică


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

  9. Quality Assurance in Distance and Open Learning (United States)

    Mahafzah, Mohammed Hasan


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

  10. Ensuring Quality Assurance in Vocational Education (United States)

    Idialu, Ethel E.


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

  11. Quality Assurance in the Presence of Variability (United States)

    Lauenroth, Kim; Metzger, Andreas; Pohl, Klaus

    Software Product Line Engineering (SPLE) is a reuse-driven development paradigm that has been applied successfully in information system engineering and other domains. Quality assurance of the reusable artifacts of the product line (e.g. requirements, design, and code artifacts) is essential for successful product line engineering. As those artifacts are reused in several products, a defect in a reusable artifact can affect several products of the product line. A central challenge for quality assurance in product line engineering is how to consider product line variability. Since the reusable artifacts contain variability, quality assurance techniques from single-system engineering cannot directly be applied to those artifacts. Therefore, different strategies and techniques have been developed for quality assurance in the presence of variability. In this chapter, we describe those strategies and discuss in more detail one of those strategies, the so called comprehensive strategy. The comprehensive strategy aims at checking the quality of all possible products of the product line and thus offers the highest benefits, since it is able to uncover defects in all possible products of the product line. However, the central challenge for applying the comprehensive strategy is the complexity that results from the product line variability and the large number of potential products of a product line. In this chapter, we present one concrete technique that we have developed to implement the comprehensive strategy that addresses this challenge. The technique is based on model checking technology and allows for a comprehensive verification of domain artifacts against temporal logic properties.

  12. Quality Assurance for Higher Education Franchising. (United States)

    Yorke, Mantz


    The practice of "franchising" higher education programs, or provision of educational programs through vendors, is examined as it occurs in the United Kingdom as a result of recent educational policy changes. A set of principles for assuring the quality of such programs is proposed. (MSE)

  13. 43 CFR 17.4 - Assurances required. (United States)


    ... financial assistance to an institution of higher education (including assistance for construction, for... treatment of students. (2) The assurance required with respect to an institution of higher education, or any... encumber the real property as security for financing construction of new, or improvement of...

  14. 45 CFR 1110.4 - Assurances required. (United States)


    ... case of any application for Federal financial assistance to an institution of higher education... of higher education or any other institution, insofar as the assurance relates to the institution's... mortgage or otherwise encumber the real property as security for financing construction of new,...

  15. 45 CFR 80.4 - Assurances required. (United States)


    ... institution of higher education (including assistance for construction, for research, for special training... assurance required with respect to an institution of higher education, hospital, or any other institution... security for financing construction of new, or improvement of existing, facilities on such property for...

  16. 13 CFR 113.4 - Assurances required. (United States)


    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Assurances required. 113.4 Section 113.4 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION NONDISCRIMINATION IN FINANCIAL... the maturity of the recipient's financial obligations to SBA in the event of a failure to comply,...

  17. 13 CFR 112.8 - Assurances required. (United States)


    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Assurances required. 112.8 Section 112.8 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION NONDISCRIMINATION IN FEDERALLY... acceleration of the maturity of the recipient's financial obligation to the SBA in the event of a failure...

  18. [Contemporary clinical medicine--assurances and uncertainties]. (United States)

    Pacovský, V


    Selected topics in the contemporary clinical medicine are reflected. The main fields of interest and characteristic features unifying theory and praxis are outlined; specificities of clinical thinking and decision making, and conception of clinical medicine as a scientific discipline are presented. Author deals with assurances, various forms of irresolution in clinical medicine and with problems resulting from the scientific progress.

  19. Software quality assurance plan for GCS (United States)

    Duncan, Stephen E.; Bailey, Elizabeth K.


    The software quality assurance (SQA) function for the Guidance and Control Software (GCS) project which is part of a software error studies research program is described. The SQA plan outlines all of the procedures, controls, and audits to be carried out by the SQA organization to ensure adherence to the policies, procedures, and standards for the GCS project.

  20. Instructional Quality Assurance at Lansing Community College. (United States)

    Herder, Dale M.; And Others

    Drawing from the experiences of Lansing Community College (LCC), this paper offers a rationale and model for measuring instructional quality. Section I offers background on LCC's efforts to assess the quality of its courses and curricula, and to introduce such quality assurance procedures as computer-based course syllabi, department and program…

  1. 30 CFR 14.8 - Quality assurance. (United States)


    ... document. If a third party is assembling or manufacturing all or part of an approved belt, the approval... MINING PRODUCTS REQUIREMENTS FOR THE APPROVAL OF FLAME-RESISTANT CONVEYOR BELTS General Provisions § 14.8... order to assure that the finished conveyor belt will meet the flame-resistance test— (1) Flame test...

  2. Transuranic Waste Characterization Quality Assurance Program Plan

    Energy Technology Data Exchange (ETDEWEB)



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

  3. Extended Deterrence and Allied Assurance: Key Concepts and Current Challenges for U.S. Policy (United States)


    to describe the phenomena of extended deterrence. Using generic terms, extended deterrence can be described as Blue deterring adversary Red the phenomena of extended deterrence and assurance: why would a state risk blood and treasure on behalf of a third party, and how much risk on...American Forces Press Service, November 16, 2011. 52 Office of the Prime Minister of Australia, “Transcript of Press Conference, Bali ,” press release

  4. Identification of Core Competencies for an Undergraduate Food Safety Curriculum Using a Modified Delphi Approach (United States)

    Johnston, Lynette M.; Wiedmann, Martin; Orta-Ramirez, Alicia; Oliver, Haley F.; Nightingale, Kendra K.; Moore, Christina M.; Stevenson, Clinton D.; Jaykus, Lee-Ann


    Identification of core competencies for undergraduates in food safety is critical to assure courses and curricula are appropriate in maintaining a well-qualified food safety workforce. The purpose of this study was to identify and refine core competencies relevant to postsecondary food safety education using a modified Delphi method. Twenty-nine…

  5. A Microbial Assessment Scheme to measure microbial performance of Food Safety Management Systems

    NARCIS (Netherlands)

    Jacxsens, L.; Kussaga, J.; Luning, P.A.; Spiegel, van der M.; Devlieghere, F.; Uyttendaele, M.


    A Food Safety Management System (FSMS) implemented in a food processing industry is based on Good Hygienic Practices (GHP), Hazard Analysis Critical Control Point (HACCP) principles and should address both food safety control and assurance activities in order to guarantee food safety. One of the mos

  6. Significance of ALT screening in the safety of blood donation by the ALT deferred donors%ALT单项不合格献血者再次献血血液筛查结果追踪调查分析

    Institute of Scientific and Technical Information of China (English)

    黎世杰; 汪传喜; 梁华钦; 廖峭; 戎霞; 陈锦艳; 林昌周; 梁浩坚


    目的 探讨和评价ALT血液筛查项目在临床用血血液安全中的意义.方法 采用回顾性调查法对2010年10月至2012年12月期间,ALT单项阳性并再次献血的献血者血液筛查结果进行追踪调查和分析.结果 3 910例再次献血者中,HBsAg、抗-HCV、抗-HIV、抗-TP以及ALT血液筛查结果均合格3 053例,占再次献血的78.1%,ALT单项仍为阳性845例,占不合格的98.6% (845/857),ALT阴性而ELISA筛查项目阳性9例,核酸筛查阳性3例,其中ALT合并NAT阳性1例.结论 ALT血液筛查在肝炎病毒感染“窗口期”或隐匿性感染中有提示的作用,在一定程度上能减少漏检的发生,在保障血液安全中具有一定的意义.%Objective To investigate and evaluate the significance of ALT screening in the safety of blood donation.Methods The blood screening results of ALT deferred donors (October 2010 to December 2012) from the Guangzhou Blood Center were investigated and analyzed by retrospective survey method.Results Among the 3 910 2nd time blood donors with previous unqualified ALT,3 053 (78.1%) donors were found to have qualified results in the testing of HBsAg,anti-HCV,anti-HIV,anti-TP and ALT screening.845 (98.6%) were found to have unqualified result with ALT screening only.Other 11 were found to have unqualified results in either ELISA or NAT,while their ALT screening result was qualified.One donor was found to have unqualified result with both ALT and NAT.Conclusion ALT screening can play a role in the monitoring of hepatitis virus infection and in reducing the risk of transmission due to the window-period and other occult infections.

  7. Measurement Assurance for End-Item Users (United States)

    Mimbs, Scott M.


    The goal of a Quality Management System (QMS) as specified in ISO 9001 and AS9100 is to assure the end product meets specifications and customer requirements. Measuring devices, often called measuring and test equipments (MTE), provide the evidence of product conformity to the prescribed requirements. Therefore the processes which employ MTE can become a weak link to the overall QMS if proper attention is not given to development and execution of these processes. Traditionally, calibration of MTE is given more focus in industry standards and process control efforts than the equally important proper usage of the same equipment. It is a common complaint of calibration laboratory personnel that MTE users are only interested in "a sticker." If the QMS requires the MTE "to demonstrate conformity of the product," then the quality of the measurement process must be adequate for the task. This leads to an ad hoc definition; measurement assurance is a discipline that assures that all processes, activities, environments, standards, and procedures involved in making a measurement produce a result that can be rigorously evaluated for validity and accuracy. To evaluate that the existing measurement processes are providing an adequate level of quality to support the decisions based upon this measurement data, an understanding of measurement assurance basics is essential. This topic is complimentary to the calibration standard, ANSI/NCSL Z540.3-2006, which targets the calibration of MTE at the organizational level. This paper will discuss general measurement assurance when MTE is used to provide evidence of product conformity, therefore the target audience of this paper is end item users of MTE. A central focus of the paper will be the verification of tolerances and the associated risks, so calibration professionals may find the paper useful in communication with their customers, MTE users.

  8. Food-Based Safety Nets and Related Programs


    Lorge Rogers, Beatrice; Coates, Jennifer


    Food-based safety net programs support adequate consumption and contribute to assuring livelihoods. They differ from other safety net programs in that they are tied to the provision of food, either directly, or through cash-like instruments (food stamps, coupons) that may be used to purchase food. Since food provided through a safety net program may be substituted for a household’s current consumption, freeing up income for other uses, food-based transfers represent a contribution to househol...

  9. Blood CoQ10 levels and safety profile after single-dose or chronic administration of PureSorb-Q40: animal and human studies. (United States)

    Nukui, Kazuki; Yamagishi, Toshihiko; Miyawaki, Hiromi; Kettawan, Aikkarach; Okamoto, Tadashi; Belardinelli, Romualdo; Tiano, Luca; Littarru, Gian Paulo; Sato, Kiyoshi


    Coenzyme Q10 (CoQ10) is known to be highly hydrophobic and, as such, insoluble in water: this leads to serious inconvenience when trying to incorporate it in food products. Its absorption is also known to be very limited. PureSorb-Q40 (P40) (Water-soluble type CoQ10 powder, CoQ10 content 40 w/w % was developed in order to improve its use with food products and to enhance its absorption. In the present study the absorption of this novel formulation was compared to a conventional lipid soluble CoQ10 by administering both products to rats and humans. Acute, single-administration studies in rats showed that P40 has a higher absorption, compared to lipid soluble CoQ10, both in prandial and fasting states. Similarly, single administration in humans revealed a higher absorption level for P40, taken in the fasting state or together with meals. In the rat study, no adverse effects were observed with P40 at doses up to 2,000 mg/kg in both sexes. In a double-blind, placebo controlled, comparative study conducted on 46 healthy volunteers and randomly divided into two groups, in the group receiving 900~mg of CoQ10 per day, for 4 consecutive weeks, the average level at two weeks was 8.79 +/- 3.34 microg/mL, similar to the corresponding level after 4 weeks (8.33 +/- 4.04 microg/mL). After 2 weeks of washout, serum CoQ10 level decreased to 1.30 +/- 0.49 microg/mL. P40 intake did not cause any significant changes in symptoms and clinical laboratory tests as assessed by physical, hematological, blood biochemical or urinalysis. Clinical examinations also did not reveal any abnormalities. The above blood (serum) CoQ10 level at 2 weeks after start of intake was compared with other reported values. The same dose of CoQ10 (900mg/day), when administered by softgel capsules yielded a plasma CoQ10 concentration of 3.6 microg/mL, while P40 levels were 8.79 +/- 3.34 microg/mL. These levels are remarkably high for instance when compared to the corresponding levels obtained, in patients

  10. A Methodological Framework for Software Safety in Safety Critical Computer Systems

    Directory of Open Access Journals (Sweden)

    P. V. Srinivas Acharyulu


    Full Text Available Software safety must deal with the principles of safety management, safety engineering and software engineering for developing safety-critical computer systems, with the target of making the system safe, risk-free and fail-safe in addition to provide a clarified differentaition for assessing and evaluating the risk, with the principles of software risk management. Problem statement: Prevailing software quality models, standards were not subsisting in adequately addressing the software safety issues for real-time safety-critical embedded systems. At present no standard framework does exist addressing the safety management and safety engineering priniciples for the development of software safety in safety-critical computer systems. Approach: In this study we propose a methodological framework involving safety management practices, safety engineering practices and software development life cycle phases for the development of software safety. In this framework we make use of the safety management practices such as planning, defining priniciples, fixing responsibilities, creteria and targets, risk assessment, design for safety, formulating safety requirements and integrating skills and techniques to address safety issues early with a vision for assurance and so on. In this framework we have also analysed integration of applicability of generic industrial heirarchy and software development heirarchy, with derived cyclical review involving safety professionals generating a nodal point for software safety. Results: This framework is applied to safety-critical software based laboratory prototype Railroad Crossing Control System (RCCS with a limited complexity. The results have shown that all critical operations were safe and risk free. Conclusion: The development of software based on the proposed framework for RCCS have shown a clarified and improved safety-critical operations of the overall system peformance.

  11. Fire safety assessment of tunnel structures

    DEFF Research Database (Denmark)

    Gkoumas, Konstantinos; Giuliani, Luisa; Petrini, Francesco


    durability provisions, commitment to environmental aspects, issues of sustainability and safety assurance, for their whole lifecycle. The design for safety of tunnel infrastructures is a multifaceted process, since there are many aspects that need to be accounted for, regarding different aspects (e...... for upgrading fire safety provisions and tunnel management are also important for existing tunnels. In this study, following a brief introduction of issues regarding the above mentioned aspects, the structural performance of a steel rib for a tunnel infrastructure subject to fire is assessed by means...


    NARCIS (Netherlands)



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

  13. Software Assurance Curriculum Project Volume 1: Master of Software Assurance Reference Curriculum (United States)


    credits per course has often aligned with the number of hours of lecture per week, but with online and other non-traditional formats becoming increasingly...development hires people to be developers and they are then selected to be SPOCs . Ergo, assurance is a collateral duty not their main job and we...Engineering Institute SIA survivability and information assurance SOA service-oriented architecture SPOC single point of contact SQL Structured Query

  14. Architecture Level Safety Analyses for Safety-Critical Systems

    Directory of Open Access Journals (Sweden)

    K. S. Kushal


    Full Text Available The dependency of complex embedded Safety-Critical Systems across Avionics and Aerospace domains on their underlying software and hardware components has gradually increased with progression in time. Such application domain systems are developed based on a complex integrated architecture, which is modular in nature. Engineering practices assured with system safety standards to manage the failure, faulty, and unsafe operational conditions are very much necessary. System safety analyses involve the analysis of complex software architecture of the system, a major aspect in leading to fatal consequences in the behaviour of Safety-Critical Systems, and provide high reliability and dependability factors during their development. In this paper, we propose an architecture fault modeling and the safety analyses approach that will aid in identifying and eliminating the design flaws. The formal foundations of SAE Architecture Analysis & Design Language (AADL augmented with the Error Model Annex (EMV are discussed. The fault propagation, failure behaviour, and the composite behaviour of the design flaws/failures are considered for architecture safety analysis. The illustration of the proposed approach is validated by implementing the Speed Control Unit of Power-Boat Autopilot (PBA system. The Error Model Annex (EMV is guided with the pattern of consideration and inclusion of probable failure scenarios and propagation of fault conditions in the Speed Control Unit of Power-Boat Autopilot (PBA. This helps in validating the system architecture with the detection of the error event in the model and its impact in the operational environment. This also provides an insight of the certification impact that these exceptional conditions pose at various criticality levels and design assurance levels and its implications in verifying and validating the designs.

  15. 7 CFR 90.102 - Quality assurance review. (United States)


    ... Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS INTRODUCTION Quality Assurance § 90.102 Quality assurance review. (a) Each laboratory performing tests...

  16. 78 FR 7816 - Quality Assurance Program Requirements (Operations) (United States)


    ...'s Agencywide Documents Access and Management System (ADAMS): You may access publicly-available... establishment of Quality Assurance (QA) controls for the implementation of managerial and administrative... COMMISSION Quality Assurance Program Requirements (Operations) AGENCY: Nuclear Regulatory Commission....

  17. 78 FR 35072 - Proposed Revisions to Reliability Assurance Program (United States)


    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Proposed Revisions to Reliability Assurance Program AGENCY: Nuclear Regulatory Commission. ACTION... Plants: LWR Edition,'' Section 17.4, ``Reliability Assurance Program.'' DATES: Submit comments by July...

  18. 10 CFR 71.103 - Quality assurance organization. (United States)


    ... management level that assures that the required authority and organizational freedom, including sufficient... location or locations where activities are performed, the organizational structure for executing the... the organizational structure, the individual(s) assigned the responsibility for assuring...

  19. Blood smear (United States)

    ... some red blood cells shaped like spheres ( hereditary spherocytosis ) Increased breakdown of RBCs Presence of RBCs with ... normal Red blood cells, elliptocytosis Red blood cells, spherocytosis Acute lymphocytic leukemia - photomicrograph Red blood cells, multiple ...

  20. Blood culture (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 ...

  1. Blood Thinners (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 transfusions (United States)

    ... this page: // 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 ...

  3. 76 FR 58049 - Atomic Safety and Licensing Board; Honeywell International, Inc.; Metropolis Works Uranium... (United States)


    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Atomic Safety and Licensing Board; Honeywell International, Inc.; Metropolis Works Uranium... assurance for its Metropolis Works uranium conversion facility in Metropolis, Illinois. \\1\\ LBP-11-19,...

  4. Vehicle Battery Safety Roadmap Guidance

    Energy Technology Data Exchange (ETDEWEB)

    Doughty, D. H.


    The safety of electrified vehicles with high capacity energy storage devices creates challenges that must be met to assure commercial acceptance of EVs and HEVs. High performance vehicular traction energy storage systems must be intrinsically tolerant of abusive conditions: overcharge, short circuit, crush, fire exposure, overdischarge, and mechanical shock and vibration. Fail-safe responses to these conditions must be designed into the system, at the materials and the system level, through selection of materials and safety devices that will further reduce the probability of single cell failure and preclude propagation of failure to adjacent cells. One of the most important objectives of DOE's Office of Vehicle Technologies is to support the development of lithium ion batteries that are safe and abuse tolerant in electric drive vehicles. This Roadmap analyzes battery safety and failure modes of state-of-the-art cells and batteries and makes recommendations on future investments that would further DOE's mission.

  5. US Army blood program: 2025 and beyond. (United States)

    Gonzales, Richard; Taylor, Audra L; Atkinson, Andrew J; Malloy, Wilbur W; Macdonald, Victor W; Cap, Andrew P


    In preparing to support the Army in 2025 and beyond, the Army Blood Program remains actively engaged with the research and advanced development of blood products and medical technology to improve blood safety and efficacy in conjunction with the US Army Medical Research and Materiel Command. National and International Blood Bank authorities have noted that the US Army research and development efforts in providing new blood products and improving blood safety operate on the cutting edge of technology and are transformational for the global blood industry. Over the past 14 years, the Army has transformed how blood support is provided and improved the survival rate of casualties. Almost every product or process developed by or for the military has found an application in treating civilian patients. Conflicts have many unwanted consequences; however, in times of conflict, one positive aspect is the identification of novel solutions to improve the safety and efficacy of the blood supply.

  6. Contaminated soil remediation and quality assurance; Pilaantuneen maan kunnostaminen ja laadunvarmistus

    Energy Technology Data Exchange (ETDEWEB)

    Sarkkila, J.; Mroueh, U.M.; Leino-Forsman, H.


    The aim of contaminated soil remediation quality assurance is to carry out remediation activities according to plans. Besides the design work the appropriate implementation of the quality assurance covers source data and investigation methods as well as the requirements for documentation. Contaminated soil characterization and the selection of the most suitable remediation method is made with the help of various sampling and analysis methods. There are different kinds of requirements to the sampling plan depending on the type of remediation project. Quality assurance is taken into account in sampling, in sample handling and analysis as well as in the reporting of results. The most common unsaturated zone remediation methods used in Finland are introduced in this guide. These methods include excavation (as part of remediation), encapsulating, stabilization, thermal desorption, soil washing, composting, soil vapor extraction and bioventing. The methods are introduced on a general level with emphasis on their technical implementation and feasibility as well as on the eventual material requirements. Harmful environmental impacts of the methods must be identified and prevented. In order to monitor the remediation process, various chemical and physical quality assurance measurements are performed. Additionally the work safety issues related to remediation methods must be taken into account and proper documentation must be prepared. (orig.)

  7. Survival after blood transfusion

    DEFF Research Database (Denmark)

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


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

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

    Energy Technology Data Exchange (ETDEWEB)

    Lackner, M.


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

  9. Quality Assurance of Assessment and Moderation Discourses Involving Sessional Staff (United States)

    Grainger, Peter; Adie, Lenore; Weir, Katie


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

  10. 10 CFR 61.63 - Financial assurances for institutional controls. (United States)


    ... 10 Energy 2 2010-01-01 2010-01-01 false Financial assurances for institutional controls. 61.63 Section 61.63 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Financial Assurances § 61.63 Financial assurances for institutional controls. (a) Prior...

  11. 10 CFR 26.137 - Quality assurance and quality control. (United States)


    ... 10 Energy 1 2010-01-01 2010-01-01 false Quality assurance and quality control. 26.137 Section 26....137 Quality assurance and quality control. (a) Quality assurance program. Each licensee testing... metabolites. (b) Performance testing and quality control requirements for validity screening tests....

  12. Quality Assurance in Postgraduate Education. ENQA Workshop Report 12 (United States)

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


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

  13. Quality Assurance in Transnational Higher Education. ENQA Workshop Report 11 (United States)

    Bennett, Paul; Bergan, Sjur; Cassar, Daniela; Hamilton, Marlene; Soinila, Michele; Sursock, Andree; Uvalic-Trumbic, Stamenka; Williams, Peter


    The present report is the product of an ENQA (European Association for Quality Assurance in Higher Education) Bologna Seminar "Quality Assurance in Transnational Education: from words to action" hosted by the Quality Assurance Agency (QAA, UK) in London in December, 2008. The seminar discussed the current trends in Transnational…

  14. 75 FR 57956 - Draft Revision of the Federalwide Assurance (United States)


    ... HUMAN SERVICES Draft Revision of the Federalwide Assurance AGENCY: Department of Health and Human... Assistant Secretary for Health, is announcing the availability of the draft revised Federalwide Assurance (FWA) form and Terms of Assurance, and is seeking comment on these draft documents. OHRP is...

  15. 44 CFR 7.9 - Assurances from institutions. (United States)


    ... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Assurances from institutions...) Nondiscrimination in FEMA-Assisted Programs-General § 7.9 Assurances from institutions. (a) In the case of any application for Federal financial assistance to an institution of higher education, the assurance required...

  16. 42 CFR 93.303 - Assurances for small institutions. (United States)


    ... 42 Public Health 1 2010-10-01 2010-10-01 false Assurances for small institutions. 93.303 Section... POLICIES ON RESEARCH MISCONDUCT Responsibilities of Institutions Compliance and Assurances § 93.303 Assurances for small institutions. (a) If an institution is too small to handle research...

  17. Internal Quality Assurance System and Its Implementation in Kaunas College (United States)

    Misiunas, Mindaugas


    The article discusses the internal system of quality assurance and its implementation methods in Kaunas College. The issues of quality assurance are reviewed in the context of the European higher education area covering the three levels: European, national and institutional. The importance of quality assurance and its links with external…

  18. Safety Plan (United States)

    US Fish and Wildlife Service, Department of the Interior — The Swan Lake National Wildlife Refuge Safety Plan discusses policies for the safety of the station employees, volunteers, and public. This plan seeks to identify...

  19. Water Safety (United States)

    ... Old Feeding Your 1- to 2-Year-Old Water Safety KidsHealth > For Parents > Water Safety Print A ... best measure of protection. previous continue Making Kids Water Wise It's important to teach your kids proper ...


    Institute of Scientific and Technical Information of China (English)


    Ensuring safety while peacefully utilizing nuclear energy is a top priority for China A fter a recent earthquake in Japan caused radioactive leaks at a nuclear power plant in Tokyo, the safety of nuclear energy has again aroused public attention.

  1. Hand Safety (United States)

    ... Gardening Safety Turkey Carving Removing a Ring Español Artritis de la base del pulgar Dedo en gatillo ... Gardening Safety Turkey Carving Removing a Ring Español Artritis de la base del pulgar Dedo en gatillo ...

  2. Implementation of Programmatic Quality and the Impact on Safety (United States)

    Huls, Dale Thomas; Meehan, Kevin


    The purpose of this paper is to discuss the implementation of a programmatic quality assurance discipline within the International Space Station Program and the resulting impact on safety. NASA culture has continued to stress safety at the expense of quality when both are extremely important and both can equally influence the success or failure of a Program or Mission. Although safety was heavily criticized in the media after Colimbiaa, strong case can be made that it was the failure of quality processes and quality assurance in all processes that eventually led to the Columbia accident. Consequently, it is possible to have good quality processes without safety, but it is impossible to have good safety processes without quality. The ISS Program quality assurance function was analyzed as representative of the long-term manned missions that are consistent with the President s Vision for Space Exploration. Background topics are as follows: The quality assurance organizational structure within the ISS Program and the interrelationships between various internal and external organizations. ISS Program quality roles and responsibilities with respect to internal Program Offices and other external organizations such as the Shuttle Program, JSC Directorates, NASA Headquarters, NASA Contractors, other NASA Centers, and International Partner/participants will be addressed. A detailed analysis of implemented quality assurance responsibilities and functions with respect to NASA Headquarters, the JSC S&MA Directorate, and the ISS Program will be presented. Discussions topics are as follows: A comparison of quality and safety resources in terms of staffing, training, experience, and certifications. A benchmark assessment of the lessons learned from the Columbia Accident Investigation (CAB) Report (and follow-up reports and assessments), NASA Benchmarking, and traditional quality assurance activities against ISS quality procedures and practices. The lack of a coherent operational

  3. Lessons learned from development and quality assurance of software systems at the Halden Project

    Energy Technology Data Exchange (ETDEWEB)

    Bjorlo, T.J.; Berg, O.; Pehrsen, M.; Dahll, G.; Sivertsen, T. [OECD Halden Reactor Project (Norway)


    The OECD Halden Reactor Project has developed a number of software systems within the research programmes. These programmes have comprised a wide range of topics, like studies of software for safety-critical applications, development of different operator support systems, and software systems for building and implementing graphical user interfaces. The systems have ranged from simple prototypes to installations in process plants. In the development of these software systems, Halden has gained much experience in quality assurance of different types of software. This paper summarises the accumulated experience at the Halden Project in quality assurance of software systems. The different software systems being developed at the Halden Project may be grouped into three categories. These are plant-specific software systems (one-of-a-kind deliveries), generic software products, and safety-critical software systems. This classification has been found convenient as the categories have different requirements to the quality assurance process. In addition, the experience from use of software development tools and proprietary software systems at Halden, is addressed. The paper also focuses on the experience gained from the complete software life cycle, starting with the software planning phase and ending with software operation and maintenance.

  4. [Quality assurance in occupational health services]. (United States)

    Michalak, J


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

  5. ALMA quality assurance: concepts, procedures, and tools (United States)

    Chavan, A. M.; Tanne, S. L.; Akiyama, E.; Kurowski, R.; Randall, S.; Vila Vilaro, B.; Villard, E.


    Data produced by ALMA for the community undergoes a rigorous quality assurance (QA) process, from the initial observation ("QA0") to the final science-ready data products ("QA2"), to the QA feedback given by the Principal Investigators (PIs) when they receive the data products ("QA3"). Calibration data is analyzed to measure the performance of the observatory and predict the trend of its evolution ("QA1"). The procedure develops over different steps and involves several actors across all ALMA locations; it is made possible by the support given by dedicated software tools and a complex database of science data, meta-data and operational parameters. The life-cycle of each involved entity is well-defined, and it prevents for instance that "bad" data (that is, data not meeting the minimum quality standards) is ever processed by the ALMA pipeline. This paper describes ALMA's quality assurance concepts and procedures, including the main enabling software components.

  6. Radiation Hardness Assurance for Space Systems (United States)

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


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

  7. Evolving Principles of Office Quality Assurance


    Norman, Lee A.


    The application of medical quality assurance principles to ambulatory patient care using the traditional methods of medical chart audit, process review, and physician education has yielded generally disappointing results in improving patient care and physician performance. Newer methods assist physicians by providing patient and medical reference data at the time of a patient's visit. Techniques for tracking treatment outcomes and patients' test results and for providing instructions to patie...

  8. On the development of quality assurance

    DEFF Research Database (Denmark)

    Andersen, Jens


    Contemporary research in quality assurance indicates that large uncertainties observed in interlaboratory comparisons to a large extent originate from a lack of competence of laboratory staff. This explanation is challenged by the present article for which six technologies and multiple series of ...... of uncertainties of certified reference materials (CRMs) gave results that differed significantly from those in the certificates of the CRMs. (C) 2014 Elsevier B.V. All rights reserved....

  9. Design quality assurance for plant modifications

    Energy Technology Data Exchange (ETDEWEB)

    Ankrum, G.T.; Norkin, D.P.; Architzel, R.


    The US Nuclear Regulatory Commission's Office of Inspection and Enforcement has conducted direct inspections of the technical aspects of the nuclear plant design process for several plants under construction. It has also evaluated independent design verification programs and engineering assurance programs at a number of other plants under construction. Many of the lessons learned from these construction phase efforts are directly applicable to operating plants undergoing major modifications.

  10. Quality Assurance Program for Molecular Medicine Laboratories


    Hajia, M; Safadel, N; Samiee, S Mirab; Dahim, P; Anjarani, S; N Nafisi; Sohrabi, A; M Rafiee; Sabzavi, F; B Entekhabi


    Background: Molecular diagnostic methods have played and continuing to have a critical role in clinical laboratories in recent years. Therefore, standardization is an evolutionary process that needs to be upgrade with increasing scientific knowledge, improvement of the instruments and techniques. The aim of this study was to design a quality assurance program in order to have similar conditions for all medical laboratories engaging with molecular tests. Methods: We had to design a plan for al...

  11. Toward a Theory of Assurance Case Confidence (United States)


    assurance case claim. The framework is based on the notion of eliminative induction—the princi- ple (first put forward by Francis Bacon ) that confidence in...eliminative induction. As first proposed by Francis Bacon [Schum 2001] and extended by L. Jonathan Cohen [Cohen 1970, 1977, 1989], eliminative induction is...eliminative in- duction—the principle (first put forward by Francis Bacon ) that confidence in the truth of a hypothesis (or claim) increases as reasons for

  12. Software Assurance Measurement -- State of the Practice (United States)


    NET 39 ActionScript 39 Ada 40 C/C++ 40 Java 41 JavaScript 42 Objective-C 42 Opa 42 Packages 42 Perl 42 PHP 42 Python 42 Formal Methods... debugging of the system, which encompasses such concerns as the probable number of software errors that will be corrected at a given time in system...testing process and the economics of debugging due to error growth. Because assurance is normally judged against failure, the use of a measurement

  13. A Clinical study on the Safety Evaluation of Blood Ammonia Detection in Parenteral Nutrition for Premature Infants%血氨检测对早产儿胃肠外营养安全评估的临床研究

    Institute of Scientific and Technical Information of China (English)

    冯彬彬; 肖娟; 曹蓓; 王鷁超; 谭浩; 李素萍; 曾云清; 彭湘莲; 龚瑾; 侯皓


    目的:探讨血氨检测在早产儿胃肠外营养安全评估的价值,为早产儿早期营养支持与诊治提供临床检测依据。方法:随机选取2012年7月1日~2014年6月30日在我院妇产科出生后24小时内需胃肠外营养的早产儿56例作为实验组,选取同期出生的24例无需胃肠外营养的早产儿作为对照组。对照组患儿给予早产儿配方奶粉或母乳喂养,实验组给予等量的胃肠外营养支持。分别测定两组早产儿治疗前、治疗后2d、7d 及出院时的血氨、尿素氮、胆红素和前白蛋白等生化指标数据,比较实验组与对照组早产儿治疗期间的血氨水平变化差异。结果:两组早产儿治疗前临床资料无明显差异,治疗后第2天实验组与对照组早产儿生化指标中血氨水平和胆红素出现显著统计学差异;治疗第7天实验组与对照组早产儿生化指标中血氨水平和尿素氮指标有显著性差异。在患儿出院时实验组与对照组早产儿的血氨、尿素氮、前白蛋白、胆红素等生化指标均无明显差异。结论:早产儿胃肠外营养支持与母乳喂养早产儿的血氨指标具有明显的差异,可将血氨检测作为早产儿胃肠外营养支持安全评估的评价指标。%Objective To evaluate the safety of blood ammonia detection in parenteral nutrition for premature infants so as to provide the clinical detection basis for early nutritional support and treatment of premature infants. Methods 56 premature infants who needed parenteral nutrition within 24 hours after their birth were randomly selected in our hospital from July 1st, 2012 to June 30th, 2014 and set as the experimental group, whereas 24 cases of premature infants born in the same period with-out the need of parenteral nutrition were set as the control group. The preterm infants in the control group were given powdered formulas or breastfed,while the infants in experimental group were given the

  14. The quality assurance program at K & S

    Energy Technology Data Exchange (ETDEWEB)

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


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

  15. Topaz II preliminary safety assessment (United States)

    Marshall, Albert C.; Standley, Vaughn; Voss, Susan S.; Haskin, Eric


    The Strategic Defense Initiative Organization (SDIO) decided to investigate the possibility of launching a Russian Topaz II space nuclear power system. A preliminary safety assessment was conducted to determine whether or not a space mission could be conducted safely and within budget constraints. As part of this assessment, a safety policy and safety functional requirements were developed to guide both the safety assessment and future Topaz II activities. A review of the Russian flight safety program was conducted and documented. Our preliminary safety assessment included a top level event tree, neutronic analysis of normal and accident configurations, an evaluation of temperature coefficients of reactivity, a reentry and disposal analysis, and analysis of postulated launch abort impact accidents, and an analysis of postulated propellant fire and explosion accidents. Based on the assessment, it appears that it will be possible to safely launch the Topaz II system in the U.S. with some possible system modifications. The principal system modifications will probably include design changes to preclude water flooded criticality and to assure intact reentry.

  16. Middle East food safety perspectives. (United States)

    Idriss, Atef W; El-Habbab, Mohammad S


    Food safety and quality assurance are increasingly a major issue with the globalisation of agricultural trade, on the one hand, and intensification of agriculture, on the other. Consumer protection has become a priority in policy-making amongst the large economies of the Middle East and North Africa (MENA) countries following a number of food safety incidents. To enhance food safety, it is necessary to establish markets underpinned by knowledge and resources, including analysis of international rejections of food products from MENA countries, international laboratory accreditation, improved reporting systems and traceability, continued development and validation of analytical methods, and more work on correlating sensory evaluation with analytical results. MENA countries should develop a national strategy for food safety based on a holistic approach that extends from farm-to-fork and involves all the relevant stakeholders. Accordingly, food safety should be a regional programme, raising awareness among policy- and decision-makers of the importance of food safety and quality for consumer protection, food trade and economic development.

  17. Blood Donation (United States)

    Tests and Procedures Blood donation By Mayo Clinic Staff Blood donation is a voluntary procedure. You agree to have blood drawn so that it can ... have a disease that requires blood components. Blood donation makes all of this possible. There are several ...

  18. Construction Safety for the National Ignition Facility

    Energy Technology Data Exchange (ETDEWEB)

    Predmore, R


    This Construction Safety Program (CSP) for the National Ignition Facility (NIF) presents safety protocols and guidelines that management and workers shall follow to assure a safe and healthful work environment. Appendix A, a separate companion document, includes further applicable environmental, safety, and health requirements for the NIF Project. Specifically this document: {sm_bullet} Defines the fundamental site safety philosophy, {sm_bullet} Identifies management roles and responsibilities, {sm_bullet} Defines core safety management processes, {sm_bullet} Identifies LLNL institutional requirements, and {sm_bullet} Defines the functional areas and facilities accrued by the program and the process for transition of facilities, functional areas, and/or systems from construction to activation. Anyone willfully or thoughtlessly disregarding standards will be subject to immediate removal from the site. Thorough job planning will help ensure that these standards are met.

  19. Assessment and Assurance of Microelectronics Packaging Technology of Microelectromechanical Systems (MEMS) (United States)

    Ramesham, Rajeshuni


    Microelectromechanical systems (MEMS) have shown a significant promise in the last decade for a variety of applications such as air-bag, pressure sensors, accelerometer, microgyro, etc. Standard semiconductor microelectronics packaging needs the integrated circuits to be protected from the harsh environment, and provide electrical communication with the other parts of the circuit, facilitate thermal dissipation efficiently, and impart mechanical strength to the silicon die. Microelectronics packaging involves wafer dicing, bonding, lead attachment, encapsulation to protect from the environment, electrical integrity, and package leak tests to assure the packaging technology. In the case of MEMS the microstructures (active elements) often interfaces with the hostile environment where packaging leak tests and testing of such devices using chemical and mechanical parameters will be very difficult and expensive. Packaging of MEMS is significantly complex as they serve to protect from the environment and microstructures interact with the same environment to measure or affect the desired physical or chemical parameters. The most of the silicon circuitry is sensitive to temperature, moisture, magnetic field, light, and electromagnetic interference. The package must then protect the on-board silicon circuitry while simultaneously exposing the microsensor to the effect it 'measures to assure the MEMS technology by lowering the risk to zero. MEMS technology has a major application in developing a microspacecraft for space systems provided assurance of MEMS technology is sufficiently addressed nondestructively. This technology would eventually miniaturize many of the components of the spacecraft to reach the NASA's safety and mission assurance goal by building faster, cheaper, better, smaller spacecraft to explore the space more effectively by teaming-up with the other NASA centers using the limited resources available. This paper discusses the latest developments in the MEMS

  20. Identification of Vehicle Health Assurance Related Trends (United States)

    Phojanamongkolkij, Nipa; Evans, Joni K.; Barr, Lawrence C.; Leone, Karen M.; Reveley, Mary S.


    Trend analysis in aviation as related to vehicle health management (VHM) was performed by reviewing the most current statistical and prognostics data available from the National Transportation Safety Board (NTSB) accident, the Federal Aviation Administration (FAA) incident, and the NASA Aviation Safety Reporting System (ASRS) incident datasets. In addition, future directions in aviation technology related to VHM research areas were assessed through the Commercial Aviation Safety Team (CAST) Safety Enhancements Reserved for Future Implementations (SERFIs), the National Transportation Safety Board (NTSB) Most-Wanted List and recent open safety recommendations, the National Research Council (NRC) Decadal Survey of Civil Aeronautics, and the Future Aviation Safety Team (FAST) areas of change. Future research direction in the VHM research areas is evidently strong as seen from recent research solicitations from the Naval Air Systems Command (NAVAIR), and VHM-related technologies actively being developed by aviation industry leaders, including GE, Boeing, Airbus, and UTC Aerospace Systems. Given the highly complex VHM systems, modifications can be made in the future so that the Vehicle Systems Safety Technology Project (VSST) technical challenges address inadequate maintenance crew's trainings and skills, and the certification methods of such systems as recommended by the NTSB, NRC, and FAST areas of change.

  1. Donating Blood (United States)

    ... can't get an infection or disease from giving blood. The needles and other equipment used are sterile ... part of blood (plasma) within 72 hours after giving blood. It generally takes about 4–8 weeks to ...

  2. The quest for quality blood banking program in the new millennium the American way. (United States)

    Kim, Dae Un


    For an industry to succeed and satisfy its customers, "QUALITY" must be a primary goal. Quality has been central to blood banking from its inception, with the evolution of a Quality Program since the opening of the first blood bank in U.S. at the Cook County Hospital in 1937. Over the ensuing decades, continuous scientific progress in blood preservation, filters, viral and blood group testing, crossmatching, automation, and computerization including bar coding, etc. has contributed to the quality and safety of the blood products and transfusion service. However, with the advent of the AIDS era, an increasingly sensitized and informed public is continuously demanding that the highest level of quality be achieved and maintained in all processes involved in providing all blood products. The Food and Drug Administration (FDA) introduced the concept of a "zero risk blood supply" as the industry goal. Furthermore, the cost containment and resource-constrained environment have changed the complexity of the quality practice. Both regulatory agencies such as the FDA, the Health Care Financing Administration [HCFA, which was recently renamed as the Centers for Medicare and Medicaid Services (CMS) in July, 2001], and the State Department of Health, and accrediting agencies, such as the American Association of Blood Banks (AABB), the College of American Pathologists (CAP), and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), require blood banks and transfusion services to establish and follow a Quality Control and Quality Assurance Program for their licensing, certification and accreditation. Every laboratory has to comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) quality requirements being implemented by the CMS. The FDA guidelines assist facilities in compliance with Current Good Manufacturing Practices (cGMP). The AABB's Quality System Essentials (QSE) are based on these specifications and provide additional guidance in

  3. Safety; Avertissement

    Energy Technology Data Exchange (ETDEWEB)



    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.)

  4. Mission assurance increased with regression testing (United States)

    Lang, R.; Spezio, M.

    Knowing what to test is an important attribute in any testing campaign, especially when it has to be right or the mission could be in jeopardy. The New Horizons mission, developed and operated by the John Hopkins University Applied Physics Laboratory, received a planned major upgrade to their Mission Operations and Control (MOC) ground system architecture. Early in the mission planning it was recognized that the ground system platform would require an upgrade to assure continued support of technology used for spacecraft operations. With the planned update to the six year operational ground architecture from Solaris 8 to Solaris 10, it was critical that the new architecture maintain critical operations and control functions. The New Horizons spacecraft is heading to its historic rendezvous with Pluto in July 2015 and then proceeding into the Kuiper Belt. This paper discusses the Independent Software Acceptance Testing (ISAT) Regression test campaign that played a critical role to assure the continued success of the New Horizons mission. The New Horizons ISAT process was designed to assure all the requirements were being met for the ground software functions developed to support the mission objectives. The ISAT team developed a test plan with a series of test case designs. The test objectives were to verify that the software developed from the requirements functioned as expected in the operational environment. As the test cases were developed and executed, a regression test suite was identified at the functional level. This regression test suite would serve as a crucial resource in assuring the operational system continued to function as required with such a large scale change being introduced. Some of the New Horizons ground software changes required modifications to the most critical functions of the operational software. Of particular concern was the new MOC architecture (Solaris 10) is Intel based and little endian, and the legacy architecture (Solaris 8) was SPA

  5. Efficacy and safety of cord blood-derived dendritic cells plus cytokine-induced killer cells combined with chemotherapy in the treatment of patients with advanced gastric cancer: a randomized Phase II study

    Directory of Open Access Journals (Sweden)

    Mu Y


    Full Text Available Ying Mu,1,* Wei-hua Wang,2,* Jia-ping Xie,1 Ying-xin Zhang,2 Ya-pei Yang,2 Chang-hui Zhou2 1Department of Gastroenterology, 2Department of Central Laboratory, Liaocheng People’s Hospital, Liaocheng Clinical School of Taishan Medical University, Liaocheng, Shandong Province, People’s Republic of China *These authors contributed equally to this work Background: Cellular immunotherapy has been widely used in the treatment of solid tumors. However, the clinical application of cord blood-derived dendritic cells and cytokine-induced killer cells (CB-DC-CIK for the treatment of gastric cancer has not been frequently reported. In this study, the efficacy and safety of CB-DC-CIK for the treatment of gastric cancer were evaluated both in vitro and in vivo. Methods: The phenotypes, cytokines, and cytotoxicity of CB-DC-CIK were detected in vitro. Patients with advanced gastric cancer were divided into the following two groups: the experimental group (CB-DC-CIK combined with chemotherapy and the control group (chemotherapy alone. The curative effects and immune function were compared between the two groups. Results: First, the results showed that combination therapy significantly increased the overall disease-free survival rate (P=0.0448 compared with chemotherapy alone. The overall survival rate (P=0.0646, overall response rate (P=0.410, and disease control rate (P=0.396 were improved in the experimental group, but these changes did not reach statistical significance. Second, the percentage of T-cell subsets (CD4+, CD3-CD56+, and CD3+CD56+ and the levels of IFN-γ, TNF-α, and IL-2, which reflect immune function, were significantly increased (P<0.05 after immunotherapy. Finally, no serious side effects appeared in patients with gastric cancer after the application of cellular immunotherapy based on CB-DC-CIK. Conclusion: CB-DC-CIK combined with chemotherapy is effective and safe for the treatment of patients with advanced gastric cancer. Keywords: cord

  6. Medication safety. (United States)

    Keohane, Carol A; Bates, David W


    Patient safety is a state of mind, not a technology. The technologies used in the medical setting represent tools that must be properly designed, used well, and assessed on an on-going basis. Moreover, in all settings, building a culture of safety is pivotal for improving safety, and many nontechnologic approaches, such as medication reconciliation and teaching patients about their medications, are also essential. This article addresses the topic of medication safety and examines specific strategies being used to decrease the incidence of medication errors across various clinical settings.

  7. Visit safety

    CERN Multimedia


    Experiment areas, offices, workshops: it is possible to have co-workers or friends visit these places.     You already know about the official visits service, the VIP office, and professional visits. But do you know about the safety instruction GSI-OHS1, “Visits on the CERN site”? This is a mandatory General Safety Instruction that was created to assist you in ensuring safety for all your visits, whatever their nature—especially those that are non-official. Questions? The HSE Unit will be happy to answer them. Write to   The HSE Unit

  8. Implementing software safety in the NASA environment (United States)

    Wetherholt, Martha S.; Radley, Charles F.


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

  9. Measurement quality assurance for radioassay laboratories

    Energy Technology Data Exchange (ETDEWEB)

    McCurdy, D.E. [Yankee Atomic Environmental Laboratory, Boston, MA (United States)


    Until recently, the quality of U.S. radioassay laboratory services has been evaluated by a limited number of governmental measurement assurance programs (MAPs). The major programs have been limited to the U.S. Department of Energy (DOE), the U.S. Environmental Protection Agency (EPA) and the U.S. Nuclear Regulatory Commission (NRC). In 1988, an industry MAP was established for the nuclear power utility industry through the U.S. Council for Energy Awareness/National Institute of Standards and Technology (USCEA/NIST). This program functions as both a MAP for utility laboratories and/or their commercial contractor laboratories, and as a traceability program for the U.S. radioactive source manufacturers and the utility laboratories. Each of these generic MAPs has been initiated and is maintained to serve the specific needs of the sponsoring agency or organization. As a result, there is diversification in their approach, scope, requirements, and degree of traceability to NIST. In 1987, a writing committee was formed under the American National Standards Institute (ANSI) N42.2 committee to develop a standard to serve as the basis document for the creation of a national measurement quality assurance (MQA) program for radioassay laboratories in the U.S. The standard is entitled, {open_quotes}Measurement Quality Assurance For Radioassay Laboratories.{open_quotes} The document was developed to serve as a guide for MQA programs maintained for the specialized sectors of the radioassay community, such as bioassay, routine environmental monitoring, environmental restoration and waste management, radiopharmaceuticals, and nuclear facilities. It was the intent of the writing committee to develop a guidance document that could be utilized to establish a laboratory`s specific data quality objectives (DQOs) that govern the operational requirements of the radioassay process, including mandated protocols and recommendations.

  10. Assuring health coverage for all in India. (United States)

    Patel, Vikram; Parikh, Rachana; Nandraj, Sunil; Balasubramaniam, Priya; Narayan, Kavita; Paul, Vinod K; Kumar, A K Shiva; Chatterjee, Mirai; Reddy, K Srinath


    Successive Governments of India have promised to transform India's unsatisfactory health-care system, culminating in the present government's promise to expand health assurance for all. Despite substantial improvements in some health indicators in the past decade, India contributes disproportionately to the global burden of disease, with health indicators that compare unfavourably with other middle-income countries and India's regional neighbours. Large health disparities between states, between rural and urban populations, and across social classes persist. A large proportion of the population is impoverished because of high out-of-pocket health-care expenditures and suffers the adverse consequences of poor quality of care. Here we make the case not only for more resources but for a radically new architecture for India's health-care system. India needs to adopt an integrated national health-care system built around a strong public primary care system with a clearly articulated supportive role for the private and indigenous sectors. This system must address acute as well as chronic health-care needs, offer choice of care that is rational, accessible, and of good quality, support cashless service at point of delivery, and ensure accountability through governance by a robust regulatory framework. In the process, several major challenges will need to be confronted, most notably the very low levels of public expenditure; the poor regulation, rapid commercialisation of and corruption in health care; and the fragmentation of governance of health care. Most importantly, assuring universal health coverage will require the explicit acknowledgment, by government and civil society, of health care as a public good on par with education. Only a radical restructuring of the health-care system that promotes health equity and eliminates impoverishment due to out-of-pocket expenditures will assure health for all Indians by 2022--a fitting way to mark the 75th year of India

  11. Quality assurance management plan special analytical support

    Energy Technology Data Exchange (ETDEWEB)

    Myers, M.L.


    It is the policy of Special Analytical Support (SAS) that the analytical aspects of all environmental data generated and processed in the laboratory, subject to the Environmental Protection Agency (EPA), U.S. Department of Energy (DOE), WDOE or other project specific requirements, be of known and acceptable quality. It is the intention of this QAPP to establish and assure that an effective quality controlled management system is maintained in order to meet the quality requirements of the intended use(s) of the data.

  12. Risk assessment in the DOE Assurance Program for Remedial Action

    Energy Technology Data Exchange (ETDEWEB)

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


    This document provides information obtained during the performance of risk assessment tasks in support of the Assurance Program for Remedial Action (APRA) sponsored by the Office of Operational Safety of the Department of Energy. We have presented a method for the estimation of projected health effects at properties in the vicinity of uranium mill tailing piles due to transported tailings or emissions from the piles. Because radon and radon daughter exposure is identified as the principal factor contributing to health effects at such properties, the basis for estimating lung cancer risk as a result of such exposure is discussed in detail. Modeling of health risk due to a secondary pathway, ingestion of contaminated, home-grown food products, is also discussed since it is a potentially important additional source of exposure in certain geographic locations. Risk assessment methods used in various mill tailings reports are reviewed. The protocols for radiological surveys conducted in DOE-sponsored remedial action programs are critically reviewed with respect to their relevance to the needs of health risk estimation. The relevance of risk assessment to the APRA program is discussed briefly.

  13. Development of public health assurance technology by radiation

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Dong Ho; Lim, Sang Yong; Yang, Jae Seung (and others)


    This project was performed to develop the radiation sterilization process of public health products and RT/BT fusion technology and to secure a detection and quarantine system of irradiated food. To establish the radiation sterilization of public health goods, current status of radiation sterilization of disposable medical equipment was investigated and the manufacturing process of disposable media for microbial cultivation were developed using a gamma sterilization. In addition, microbial contamination of disposable kitchen utensils was surveyed and pathogen-free organic compost was developed by radiation sterilization. The radiation responses of bacteria including Salmonella, Vibrio, E. coli, and D. radiodurans were analyzed by DNA chip and 2-D electrophoresis. To validate the safety of surviving bacteria after irradiation, the expressions of virulence genes of pathogenic bacteria were monitored using real-time PCR, and the growth of mycotoxin-producing funguses was studied after irradiation. And also, quantitative detection methods of irradiated and inactivated Salmonella using a real-time PCR and a immuno assay. To establish the quarantine and quality assurance of irradiated food and public health products, radiation technology was applied to the fermented foods, minimally processed food and dried vegetables. Radiation effects on insects was examined and the corresponding data base was constructed. We also collaborated on the preliminary test of international trade of sea food with USA or India. To establish the official detection method of irradiated food, physical, chemical and biological detection methods for irradiated food were verified. Finally, multiple range test of irradiated food was performed.

  14. Order of blood draw

    DEFF Research Database (Denmark)

    Cornes, Michael; van Dongen-Lases, Edmée; Grankvist, Kjell


    , CLSI) guidelines recommend that the order of draw of blood during phlebotomy should be blood culture/sterile tubes, then plain tubes/gel tubes, then tubes containing additives. This prevents contamination of sample tubes with additives from previous tubes that could cause erroneous results. There have...... Medicine Working Group for the Preanalytical Phase (EFLM WG-PRE) provides an overview and summary of the literature with regards to order of draw in venous blood collection. Given the evidence presented in this article, the EFLM WG-PRE herein concludes that a significant frequency of sample contamination...... does occur if order of draw is not followed during blood collection and when performing venipuncture under less than ideal circumstances, thus putting patient safety at risk. Moreover, given that order of draw is not difficult to follow and knowing that ideal phlebotomy conditions and protocols...

  15. Assessment of Primary Production of Horticultural Safety Management Systems of Mushroom Farms in South Africa. (United States)

    Dzingirayi, Garikayi; Korsten, Lise


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

  16. Quality Assurance of Quality Assurance Agencies from an Asian Perspective: Regulation, Autonomy and Accountability (United States)

    Hou, Angela Yung-Chi; Ince, Martin; Tsai, Sandy; Chiang, Chung Lin


    As quality guardians of higher education, quality assurance agencies are required to guarantee the credibility of the review process and to ensure the objectivity and transparency of their decisions and recommendations. These agencies are therefore expected to use a range of internal and external approaches to prove the quality of their review…

  17. A Study on a Software Quality Assurance of a Process and a Product

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Hyun Tae [Korea Atomic Energy Research Institute, Taejon (Korea, Republic of)


    Since nuclear plants and facilities have made increasing use of digital technology, the safety and reliability of software is a primary concern. Software errors are more difficult to detect and handle than hardware-related failures. It is crucial to consider the a process and a product of a software life cycle to increase the quality of a software. This paper discusses the quality assurance of a process and a product of a software life cycle based on two prominent standards, ISO 9001:2000 and CMMI.

  18. A method for critical software event execution reliability in high assurance systems

    Energy Technology Data Exchange (ETDEWEB)

    Kidd, M.E.C.


    This paper presents a method for Critical Software Event Execution Reliability (Critical SEER). The Critical SEER method is intended for high assurance software that operates in an environment where transient upsets could occur, causing a disturbance of the critical software event execution order, which could cause safety or security hazards. The method has a finite automata based module that watches (hence SEER) and tracks the critical events and ensures they occur in the proper order or else a fail safe state is forced. This method is applied during the analysis, design and implementation phases of software engineering.

  19. Safety Instructions

    CERN Multimedia


    Please note that the Safety Instructions N0 37 rev. 3 (IS 37 rev. 3) entitled ""LEVEL-3" SAFETY ALARMS AND ALARM SYSTEMS" Is available on the web at the following URL: Paper copies can also be obtained from the TIS divisional secretariat, e-mail: TIS Secretariat

  20. Safety Systems (United States)

    Halligan, Tom


    Colleges across the country are rising to the task by implementing safety programs, response strategies, and technologies intended to create a secure environment for teachers and students. Whether it is preparing and responding to a natural disaster, health emergency, or act of violence, more schools are making campus safety a top priority. At…

  1. Iron deficiency in blood donors

    Directory of Open Access Journals (Sweden)

    Armando Cortés


    nivel more high in standars of accepted of hemoglobin no help the situation and no assure the blood suplly; increased exclusion blood donors of 9% at 44.6%.

  2. Quality-assurance needs and goals in solar energy conversion

    Energy Technology Data Exchange (ETDEWEB)

    Gross, G. E.


    A discussion of the status of quality assurance activities in solar energy conversion technologies and of the needs for further efforts in this area is presented. The importance of reliability and quality assurance activities to various end users is briefly discussed. Some details of such activities in wind, active heating and cooling, and photovoltaic technologies are given. Suggestions for an inegrated reliability, quality assurance program are presented and their importance to the growth of solar energy application is discussed.

  3. LOFT pressurizer safety: relief valve reliability

    Energy Technology Data Exchange (ETDEWEB)

    Brown, E.S.


    The LOFT pressurizer self-actuating safety-relief valves are constructed to the present state-of-the-art and should have reliability equivalent to the valves in use on PWR plants in the U.S. There have been no NRC incident reports on valve failures to lift that would challenge the Technical Specification Safety Limit. Fourteen valves have been reported as lifting a few percentage points outside the +-1% Tech. Spec. surveillance tolerance (9 valves tested over and 5 valves tested under specification). There have been no incident reports on failures to reseat. The LOFT surveillance program for assuring reliability is equivalent to nuclear industry practice.

  4. Commercial Crew Program Crew Safety Strategy (United States)

    Vassberg, Nathan; Stover, Billy


    The purpose of this presentation is to explain to our international partners (ESA and JAXA) how NASA is implementing crew safety onto our commercial partners under the Commercial Crew Program. It will show them the overall strategy of 1) how crew safety boundaries have been established; 2) how Human Rating requirements have been flown down into programmatic requirements and over into contracts and partner requirements; 3) how CCP SMA has assessed CCP Certification and CoFR strategies against Shuttle baselines; 4) Discuss how Risk Based Assessment (RBA) and Shared Assurance is used to accomplish these strategies.

  5. Quality Assurance: Strategic Choices for Higher Education in Turkey

    Directory of Open Access Journals (Sweden)

    Mahmut ÖZER


    Full Text Available As the number of students and higher education institutions in the world increases and there is a growing difficulty in financing the higher education systems, decision-makers have begun to show more interest in quality assurance. As quality assurance is given special attention in European countries, developing countries such as Turkey are interested in importing quality assurance systems. It is not possible to set quality assurance without sensitivity toward quality and without having quality as a cultural practice. The most likely encountered quality assurance approach in the world is that the higher education institution itself is responsible for its quality. In addition, external quality assurance procedures used are based on (academic peer review rather than on bureaucratic evaluations. Moreover, there is a lively debate across the world regarding the bureaucratic regulations of the quality assurance agencies and institutions that restrict the autonomy of higher education institutions. Without taking into consideration of the existing centralized structure of the higher education system in Turkey, of meeting social demands for the higher education, and of current higher education enrollment rates, the possible establishment of a quality assurance mechanism that may have sanctions on universities in Turkey is a threat to already limited autonomy of universities and is having a risk of additional bureaucratic burden. By laying out the roles and responsibilities of Turkish Council of Higher Education, the government and universities, this article discusses policies that should be adopted regarding the quality assurance.

  6. National Ignition Facility Project Site Safety Program

    Energy Technology Data Exchange (ETDEWEB)

    Dun, C


    This Safety Program for the National Ignition Facility (NIF) presents safety protocols and requirements that management and workers shall follow to assure a safe and healthful work environment during activities performed on the NIF Project site. The NIF Project Site Safety Program (NPSSP) requires that activities at the NIF Project site be performed in accordance with the ''LLNL ES&H Manual'' and the augmented set of controls and processes described in this NIF Project Site Safety Program. Specifically, this document: (1) Defines the fundamental NIF site safety philosophy. (2) Defines the areas covered by this safety program (see Appendix B). (3) Identifies management roles and responsibilities. (4) Defines core safety management processes. (5) Identifies NIF site-specific safety requirements. This NPSSP sets forth the responsibilities, requirements, rules, policies, and regulations for workers involved in work activities performed on the NIF Project site. Workers are required to implement measures to create a universal awareness that promotes safe practice at the work site and will achieve NIF management objectives in preventing accidents and illnesses. ES&H requirements are consistent with the ''LLNL ES&H Manual''. This NPSSP and implementing procedures (e.g., Management Walkabout, special work procedures, etc.,) are a comprehensive safety program that applies to NIF workers on the NIF Project site. The NIF Project site includes the B581/B681 site and support areas shown in Appendix B.

  7. Research progress of impact of occult hepatitis B virus infection on safety of blood transfusion%献血者隐匿性乙型肝炎病毒感染对输血安全影响的研究进展

    Institute of Scientific and Technical Information of China (English)



    At present,hepatitis B virus surface antigen (HBsAg) is the only mandatory index of hepatitis B virus (HBV) infection for blood donor in China.Because of undetected screening sometimes,occult HBV infection (OBI) of blood donors can affect blood safety.The incidence of OBI in blood donors is different in different countries or regions,ranging from 0.000 2 % to 0.111%.OBI prevalence is relatively high in HBV high prevalence countries and regions.HBV can be transmitted to blood recipients from blood components of OBI blood donors.HBV transmission rate is high in OBI blood donors with hepatitis B core antibody (anti-HBc) positive,while low in those with hepatitis B surface antibody (anti-HBs) positive.The HBV infectivity of OBI blood donors is related to the amount of blood plasma,viral load and immune status of the recipients.In order to reduce the risk of HBV transmission by OBI blood donors,nucleic acid testing can be used while improving the detection sensitivity of HBsAg.The number of blood donors' blood samples for nucleic acid testing can be reduced,and anti-HBc screening can be used in HBV low endemic area.The authors intend to summarize the correlation between OBI blood donation and HBV infection after blood transfusion,and further explore the effects of blood components from OBI donors on blood recipients.This review aims to reveal impact of OBI on the safety of blood transfusion.%目前乙型肝炎病毒表面抗原(HBsAg)是我国进行献血者进行乙型肝炎病毒(HBV)感染筛查的唯一强制性指标.献血者隐匿性HBV感染(OBI)可能因为筛查而被漏检,影响输血安全.文献报道的献血者中OBI发生率在不同国家或地区不同,为(0.2~111)/10万.HBV高流行国家和地区中,OBI发生率亦相对较高.OBI献血者可将HBV传播给受血者,乙型肝炎核心抗体(anti-HBc)呈阳性的OBI献血者,通过血液制品传播HBV几率较大,而乙型肝炎表面抗体(anti-HBs)呈阳性的OBI献血者,通过血液制品

  8. Determinants and Stakeholders Influencing Children's Road Safety Education


    Alonso Plá, Francisco Manuel; Esteban Martínez, Cristina; Useche, Sergio A.; Manso Pérez, Violeta


    Road safety education is, widely, the best base and the greatest assurance of the future in terms of road safety prevention and promotion. Nowadays, RSE constitutes one of the main growing concerns in terms of complimentary education in many countries, taking into account, among other factors, the high rates of accidents that affect the health and welfare of childhood and adolescence. Furthermore, it is a necessity for the community health to create, train, encourage and lead positives attitu...

  9. Safety of timber: An analysis of quality control options

    NARCIS (Netherlands)

    Kovryga, A.; Stapel, P.; Van de Kuilen, J.W.G.


    The quality assurance of timber properties is important for the safety of timber structures. In the current study, the quality control options of timber are analysed under the prism of the different growth regions. Therefore, these options - machine and output control - are simulated in accordance w

  10. Artificial blood

    Directory of Open Access Journals (Sweden)

    Sarkar Suman


    Full Text Available Artificial blood is a product made to act as a substitute for red blood cells. While true blood serves many different functions, artificial blood is designed for the sole purpose of transporting oxygen and carbon dioxide throughout the body. Depending on the type of artificial blood, it can be produced in different ways using synthetic production, chemical isolation, or recombinant biochemical technology. Development of the first blood substitutes dates back to the early 1600s, and the search for the ideal blood substitute continues. Various manufacturers have products in clinical trials; however, no truly safe and effective artificial blood product is currently marketed. It is anticipated that when an artificial blood product is available, it will have annual sales of over $7.6 billion in the United States alone.

  11. Artificial blood. (United States)

    Sarkar, Suman


    Artificial blood is a product made to act as a substitute for red blood cells. While true blood serves many different functions, artificial blood is designed for the sole purpose of transporting oxygen and carbon dioxide throughout the body. Depending on the type of artificial blood, it can be produced in different ways using synthetic production, chemical isolation, or recombinant biochemical technology. Development of the first blood substitutes dates back to the early 1600s, and the search for the ideal blood substitute continues. Various manufacturers have products in clinical trials; however, no truly safe and effective artificial blood product is currently marketed. It is anticipated that when an artificial blood product is available, it will have annual sales of over $7.6 billion in the United States alone.

  12. Blood Far Forward - A Whole Blood Research and Training Program for Austere Environments (United States)


    to the use of whole blood and blood components far forward, hence the name BFF research program. After communication with Norwegian and interna- tional...medical personnel. Optimal hemotherapy in patients with massive bleeding is still debated in relation to usage of blood components , crystalloids, of collection and administration for whole blood or blood components , especially when it is provided by personnel without formal health care

  13. Consumers Valuations and choice Processes of Food Safety Enhancement Attributes: An International Study of Beef Consumers

    NARCIS (Netherlands)

    Tonsor, G.T.; Schroeder, T.C.; Pennings, J.M.E.; Mintert, J.


    Abstract Food safety concerns have had dramatic impacts on food and livestock markets in recent years. Here we examine consumer preferences for various beef food safety assurances. In particular, we evaluate the extent to which such preferences are heterogeneous within and across country-of-residenc

  14. Effects of auditing patient safety in hospital care: design of a mixed-method evaluation

    NARCIS (Netherlands)

    Hanskamp-Sebregts, M.E.; Zegers, M.; Boeijen, W.M.J.; Westert, G.P.; Gurp, P.J.M. van; Wollersheim, H.C.


    BACKGROUND: Auditing of patient safety aims at early detection of risks of adverse events and is intended to encourage the continuous improvement of patient safety. The auditing should be an independent, objective assurance and consulting system. Auditing helps an organisation accomplish its objecti

  15. Consumer Valuations of Beef Steak Food Safety Enhancement in Canada, Japan, Mexico, and the United States

    NARCIS (Netherlands)

    Tonsor, G.T.; Schroeder, T.C.; Pennings, J.M.E.; Mintert, J.


    Food safety concerns have had dramatic impacts on food and livestock markets in recent years. We examine consumer preferences for beef steak food safety assurances. We evaluate the extent to which preferences are heterogeneous within and across country-of-residence defined groups and examine the dis

  16. Quality and safety aspects of reusable plastic food packaging materials : influence of reuse on intrinsic properties

    NARCIS (Netherlands)

    Jetten, J.; Kruijf, N. de


    The aim of the project was to develop a comprehensive package of quality assurance criteria for use by the industry and by regulatory authorities to ensure the quality and safety-in-use (sensory, microbiological and chemical safety) of reused plastics for food packaging. The paper describes the inve

  17. High-Assurance Software: LDRD Report.

    Energy Technology Data Exchange (ETDEWEB)

    Hulette, Geoffrey Compton


    This report summarizes our work on methods for developing high-assurance digital systems. We present an approach for understanding and evaluating trust issues in digital systems, and for us- ing computer-checked proofs as a means for realizing this approach. We describe the theoretical background for programming with proofs based on the Curry-Howard correspondence, connect- ing the field of logic and proof theory to programs. We then describe a series of case studies, intended to demonstrate how this approach might be adopted in practice. In particular, our stud- ies elucidate some of the challenges that arise with this style of certified programming, including induction principles, generic programming, termination requirements, and reasoning over infinite state spaces.

  18. Radiation Hardness Assurance (RHA) for Space Systems (United States)

    Poivey, Christian; Buchner, Stephen


    This presentation discusses radiation hardness assurance (RHA) for space systems, providing both the programmatic aspects of RHA and the RHA procedure. 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 space radiation environment. RHA also pertains to environment definition, part selection, part testing, spacecraft layout, radiation tolerant design, and mission/system/subsystems requirements. RHA procedure consists of establishing mission requirements, defining and evaluating the radiation hazard, selecting and categorizing the appropriate parts, and evaluating circuit response to hazard. The RHA approach is based on risk management and is confined only to parts, it includes spacecraft layout, system/subsystem/circuit design, and system requirements and system operations. RHA should be taken into account in the early phases of a program including the proposal and feasibility analysis phases.

  19. SAPHIRE 8 Volume 6 - Quality Assurance

    Energy Technology Data Exchange (ETDEWEB)

    C. L. Smith; R. Nims; K. J. Kvarfordt


    The Systems Analysis Programs for Hands-on Integrated Reliability Evaluations (SAPHIRE) Version 8 is a software application developed for performing a complete probabilistic risk assessment using a personal computer running the Microsoft Windows™ operating system. SAPHIRE 8 is funded by the U.S. Nuclear Regulatory Commission (NRC). The role of the INL in this project is that of software developer and tester. This development takes place using formal software development procedures and is subject to quality assurance (QA) processes. The purpose of this document is to describe how the SAPHIRE software QA is performed for Version 8, what constitutes its parts, and limitations of those processes. In addition, this document describes the Independent Verification and Validation that was conducted for Version 8 as part of an overall QA process.

  20. ATLAS Pixel IBL: Stave Quality Assurance

    CERN Document Server

    The ATLAS collaboration


    For Run 2 of the LHC a fourth innermost Pixel Detector layer on a smaller radius beam pipe has been installed in the ATLAS Detector to add redundancy against radiation damage of the current Pixel Detector and to ensure a high quality tracking and b-tagging performance of the Inner Detector over the coming years until the High Luminosity Upgrade. State of the art components have been produced and assembled onto support structures known as staves over the last two years. In total, 20 staves have been built and qualified in a designated Quality Assurance setup at CERN of which 14 have been integrated onto the beam pipe. Results from the testing are presented.

  1. Vaccine Safety (United States)

    ... Tweet Share Compartir Back to School: Vaccines for Preteens Learn about the safety of Tdap, Meningococcal, and ... file Microsoft Word file Microsoft Excel file Audio/Video file Apple Quicktime file RealPlayer file Text file ...

  2. Quality-assurance plan for groundwater activities, U.S. Geological Survey, Washington Water Science Center (United States)

    Kozar, Mark D.; Kahle, Sue C.


    This report documents the standard procedures, policies, and field methods used by the U.S. Geological Survey’s (USGS) Washington Water Science Center staff for activities related to the collection, processing, analysis, storage, and publication of groundwater data. This groundwater quality-assurance plan changes through time to accommodate new methods and requirements developed by the Washington Water Science Center and the USGS Office of Groundwater. The plan is based largely on requirements and guidelines provided by the USGS Office of Groundwater, or the USGS Water Mission Area. Regular updates to this plan represent an integral part of the quality-assurance process. Because numerous policy memoranda have been issued by the Office of Groundwater since the previous groundwater quality assurance plan was written, this report is a substantial revision of the previous report, supplants it, and contains significant additional policies not covered in the previous report. This updated plan includes information related to the organization and responsibilities of USGS Washington Water Science Center staff, training, safety, project proposal development, project review procedures, data collection activities, data processing activities, report review procedures, and archiving of field data and interpretative information pertaining to groundwater flow models, borehole aquifer tests, and aquifer tests. Important updates from the previous groundwater quality assurance plan include: (1) procedures for documenting and archiving of groundwater flow models; (2) revisions to procedures and policies for the creation of sites in the Groundwater Site Inventory database; (3) adoption of new water-level forms to be used within the USGS Washington Water Science Center; (4) procedures for future creation of borehole geophysics, surface geophysics, and aquifer-test archives; and (5) use of the USGS Multi Optional Network Key Entry System software for entry of routine water-level data

  3. Assured Mission Support Space Architecture (AMSSA) study (United States)

    Hamon, Rob


    The assured mission support space architecture (AMSSA) study was conducted with the overall goal of developing a long-term requirements-driven integrated space architecture to provide responsive and sustained space support to the combatant commands. Although derivation of an architecture was the focus of the study, there are three significant products from the effort. The first is a philosophy that defines the necessary attributes for the development and operation of space systems to ensure an integrated, interoperable architecture that, by design, provides a high degree of combat utility. The second is the architecture itself; based on an interoperable system-of-systems strategy, it reflects a long-range goal for space that will evolve as user requirements adapt to a changing world environment. The third product is the framework of a process that, when fully developed, will provide essential information to key decision makers for space systems acquisition in order to achieve the AMSSA goal. It is a categorical imperative that military space planners develop space systems that will act as true force multipliers. AMSSA provides the philosophy, process, and architecture that, when integrated with the DOD requirements and acquisition procedures, can yield an assured mission support capability from space to the combatant commanders. An important feature of the AMSSA initiative is the participation by every organization that has a role or interest in space systems development and operation. With continued community involvement, the concept of the AMSSA will become a reality. In summary, AMSSA offers a better way to think about space (philosophy) that can lead to the effective utilization of limited resources (process) with an infrastructure designed to meet the future space needs (architecture) of our combat forces.

  4. The role of reliability graph models in assuring dependable operation of complex hardware/software systems (United States)

    Patterson-Hine, F. A.; Davis, Gloria J.; Pedar, A.


    The complexity of computer systems currently being designed for critical applications in the scientific, commercial, and military arenas requires the development of new techniques for utilizing models of system behavior in order to assure 'ultra-dependability'. The complexity of these systems, such as Space Station Freedom and the Air Traffic Control System, stems from their highly integrated designs containing both hardware and software as critical components. Reliability graph models, such as fault trees and digraphs, are used frequently to model hardware systems. Their applicability for software systems has also been demonstrated for software safety analysis and the analysis of software fault tolerance. This paper discusses further uses of graph models in the design and implementation of fault management systems for safety critical applications.

  5. Safety first!

    CERN Multimedia


    Among the many duties I assumed at the beginning of the year was the ultimate responsibility for Safety at CERN: the responsibility for the physical safety of the personnel, the responsibility for the safe operation of the facilities, and the responsibility to ensure that CERN acts in accordance with the highest standards of radiation and environmental protection.   The Safety Policy document drawn up in September 2014 is an excellent basis for the implementation of Safety in all areas of CERN’s work. I am happy to commit during my mandate to help meet its objectives, not least by ensuring the Organization makes available the necessary means to achieve its Safety objectives. One of the main objectives of the HSE (Occupational Health and Safety and Environmental Protection) unit in the coming months is to enhance the measures to minimise CERN’s impact on the environment. I believe CERN should become a role model for an environmentally-aware scientific research laboratory. Risk ...

  6. Lexique risque sécurité, financement, assurance, réassurance

    CERN Document Server

    Lesobre, Jacques; Cave, Frances J.


    La mondialisation fait de la maîtrise du risque un enjeu majeur pour la pérennité et le développement de l'activité économique à l'échelle planétaire. Le lexique risque - français, anglais et américain, s'inscrit pleinement dans cette perspective. Avec plus de 12 000 termes et locutions et 3 000 abréviations et sigles, il répond aux incertitudes et incompréhensions terminologiques en matière de sécurité, de prévention, d'analyse et de contrôle des risques (y compris financiers), d'assurance et de réassurance. Les termes, même les plus ésotériques, sont désormais à votre portée.

  7. Colonoscopy Quality Assurance in Ontario: Systematic Review and Clinical Practice Guideline

    Directory of Open Access Journals (Sweden)

    Jill Tinmouth


    Full Text Available Colonoscopy is fundamental to the diagnosis and management of digestive diseases and plays a key role in colorectal cancer (CRC screening and diagnosis. Therefore, it is important to ensure that colonoscopy is of high quality. The present guidance document updates the evidence and recommendations in Cancer Care Ontario’s 2007 Colonoscopy Standards, and was conducted under the aegis of the Program in Evidence-Based Care. It is intended to support quality improvement for colonoscopies for all indications, including follow-up to a positive fecal occult blood test, screening for individuals who have a family history of CRC and those at average risk, investigation for symptomatic patients, and surveillance of those with a history of adenomatous polyps or CRC. A systematic review was performed to evaluate the existing evidence concerning the following three key aspects of colonoscopy: physician endoscopist training and maintenance of competency; institutional quality assurance parameters; and colonoscopy quality indicators and auditable outcomes. Where appropriate, indicators were designated quality indicators (where there was sufficient evidence to recommend a specific target and auditable outcomes (insufficient evidence to recommend a specific target, but which should be monitored for quality assurance purposes. The guidance document may be used to support colonoscopy quality assurance programs to improve the quality of colonoscopy regardless of indication. Improvements in colonoscopy quality are anticipated to improve important outcomes in digestive diseases, such as reduction of the incidence of and mortality from CRC.

  8. 42 CFR 440.390 - Assurance of transportation. (United States)


    ... 42 Public Health 4 2010-10-01 2010-10-01 false Assurance of transportation. 440.390 Section 440...-Equivalent Coverage § 440.390 Assurance of transportation. If a benchmark or benchmark-equivalent plan does not include transportation to and from medically necessary covered Medicaid services, the State...

  9. 42 CFR 431.53 - Assurance of transportation. (United States)


    ... 42 Public Health 4 2010-10-01 2010-10-01 false Assurance of transportation. 431.53 Section 431.53... Requirements § 431.53 Assurance of transportation. A State plan must— (a) Specify that the Medicaid agency will ensure necessary transportation for recipients to and from providers; and (b) Describe the methods...

  10. Study on Integrated Quality Assurance System in CIMS

    Institute of Scientific and Technical Information of China (English)


    Integrated Quality Assurance System (IQAS) is an important part of CIMS.This paper introduces the architecture of IQAS,elaborates the philosophy of quality assurance and quality control in CIMS.A type of function model is proposed.Meanwhile, details of the model are described.

  11. Regulating and Quality-Assuring VET: International Developments. Research Report (United States)

    Misko, Josie


    The opening-up of the market for education and training, including vocational education and training (VET), has increased the importance of regulation and quality assurance mechanisms in ensuring the integrity of qualifications. This report investigates approaches to the regulation and quality assurance of vocational education and training in a…

  12. Product assurance policies and procedures for flight dynamics software development (United States)

    Perry, Sandra; Jordan, Leon; Decker, William; Page, Gerald; Mcgarry, Frank E.; Valett, Jon


    The product assurance policies and procedures necessary to support flight dynamics software development projects for Goddard Space Flight Center are presented. The quality assurance and configuration management methods and tools for each phase of the software development life cycles are described, from requirements analysis through acceptance testing; maintenance and operation are not addressed.

  13. 75 FR 57274 - Financial Management and Assurance; Government Auditing Standards (United States)


    ... OFFICE Financial Management and Assurance; Government Auditing Standards AGENCY: . Public Law 67-13, 42 Stat. 20. James R. Dalkin, Director, Financial Management and Assurance... necessary changes. The Advisory Council includes experts in financial and performance auditing drawn...

  14. Quality Assurance of E-learning. ENQA Workshop Report 14 (United States)

    Grifoll, Josep; Huertas, Esther; Prades, Anna; Rodriguez, Sebastian; Rubin, Yuri; Mulder, Fred; Ossiannilsson, Ebba


    E-learning in the European Higher Education Area has stampeded its way to the foreground of the Quality Assurance (QA) forum, and has become a key issue among quality assurance agencies and institutions in the European Higher Education Area (EHEA). Because internet-based learning is currently such a relevant topic, there is a dire need for the…

  15. Internal Quality Assurance Benchmarking. ENQA Workshop Report 20 (United States)

    Blackstock, Douglas; Burquel, Nadine; Comet, Nuria; Kajaste, Matti; dos Santos, Sergio Machado; Marcos, Sandra; Moser, Marion; Ponds, Henri; Scheuthle, Harald; Sixto, Luis Carlos Velon


    The Internal Quality Assurance group of ENQA (IQA Group) has been organising a yearly seminar for its members since 2007. The main objective is to share experiences concerning the internal quality assurance of work processes in the participating agencies. The overarching theme of the 2011 seminar was how to use benchmarking as a tool for…

  16. Quality Assurance in South Africa: A Reply to John Mammen (United States)

    le Grange, L.


    In this article I point out that prominence given to higher education quality assurance by contemporary states might be viewed in the context of the ascendance of neoliberalism over the past few decades and a concomitant culture of performativity. However, I argue for a shift in the angle of vision on performativity and quality assurance through a…

  17. Quality Assurance and Accreditation of Engineering Education in Jordan (United States)

    Aqlan, Faisal; Al-Araidah, Omar; Al-Hawari, Tarek


    This paper provides a study of the quality assurance and accreditation in the Jordanian higher education sector and focuses mainly on engineering education. It presents engineering education, accreditation and quality assurance in Jordan and considers the Jordan University of Science and Technology (JUST) for a case study. The study highlights the…

  18. Cui Bono? The Relevance and Impact of Quality Assurance (United States)

    Massaro, Vin


    External quality assurance of universities exists to assure society that higher education standards are adequate and, in an increasingly global market, that they are comparable internationally. Although society has accepted an implicit compact in giving autonomy to universities in return for their dispassionate service to it, there has been an…

  19. Quality assurance of absorbed energy in Charpy impact test (United States)

    Rocha, C. L. F.; Fabricio, D. A. K.; Costa, V. M.; Reguly, A.


    In order to ensure the quality assurance and comply with standard requirements, an intralaboratory study has been performed for impact Charpy tests, involving two operators. The results based on ANOVA (Analysis of Variance) and Normalized Error statistical techniques pointed out that the execution of the tests is appropriate, because the implementation of quality assurance methods showed acceptable results.

  20. The Landscape of Quality Assurance in Distance Education (United States)

    Scull, W. Reed; Kendrick, David; Shearer, Rick; Offerman, Dana


    Distance education permeates the field of professional and continuing education to such an extent that quality assurance (QA) is a topic no distance educator or administrator should avoid. Quality assurance is an issue not just for continuing education but also for higher education generally. Given the disruptive impact of distance education and…

  1. 10 CFR 4.24 - Assurances from institutions. (United States)


    ... 10 Energy 1 2010-01-01 2010-01-01 false Assurances from institutions. 4.24 Section 4.24 Energy... from institutions. (a) In the case of a grant, loan or contract involving Federal financial assistance to an institution of higher education, the assurance required by § 4.21 shall extend to...

  2. Where Is Quality Assurance Going in Dental School Curricula? (United States)

    Loupe, Michael J.


    The quality assurance consortium begun in 1979 and similar professional and foundation projects have influenced dental school curriculum development in the last decade. Other forces driving development of academic and practice programs for quality assurance include cost containment, risk management, electronic technology, and developments in…

  3. A Rotational Blended Learning Model: Enhancement and Quality Assurance (United States)

    Ghoul, Said


    Research on blended learning theory and practice is growing nowadays with a focus on the development, evaluation, and quality assurance of case studies. However, the enhancement of blended learning existing models, the specification of their online parts, and the quality assurance related specifically to them have not received enough attention.…

  4. Quality Assurance of Joint Programmes. ENQA Workshop Report 19 (United States)

    Frederiks, Mark; Grifoll, Josep; Hiltunen, Kirsi; Hopbach, Achim


    In view of the Bologna ministerial conference to be held in April 2012 in Bucharest, ENQA organised a seminar in September 2011 on Quality Assurance of Joint Programmes in collaboration with the Austrian Accreditation Council (OAR). The purpose of this seminar was twofold: first, to analyse the experience already gained in quality assurance of…

  5. 10 CFR 830.121 - Quality Assurance Program (QAP). (United States)


    ... 10 Energy 4 2010-01-01 2010-01-01 false Quality Assurance Program (QAP). 830.121 Section 830.121... Assurance Program (QAP). (a) Contractors conducting activities, including providing items or services, that... must: (1) Submit a QAP to DOE for approval and regard the QAP as approved 90 days after...

  6. Quality Assurance Program Plan for radionuclide airborne emissions monitoring

    Energy Technology Data Exchange (ETDEWEB)

    Vance, L.M.


    This Quality Assurance Program Plan (QAPP) describes the quality assurance requirements and responsibilities for radioactive airborne emissions measurements activities from regulated stacks are controlled at the Hanford Site. Detailed monitoring requirements apply to stacks exceeding 1% of the standard of 10 mrem annual effective dose equivalent to the maximally exposed individual from operations of the Hanford Site.

  7. Quality assurance and evidence in career guidance in Europe

    DEFF Research Database (Denmark)

    Plant, Peter


    Quality assurance and evidence in career guidance in Europe is based on a particular, positivtic model. Other approaches are largely neglected.......Quality assurance and evidence in career guidance in Europe is based on a particular, positivtic model. Other approaches are largely neglected....

  8. Quality assurance, information tracking, and consumer labeling. (United States)

    Caswell, Julie A


    Reducing marine-based public health risk requires strict control of several attributes of seafood products, often including location and conditions of catch or aquaculture, processing, and handling throughout the supply chain. Buyers likely will also be interested in other attributes of these products such as eco-friendliness or taste. Development of markets for improved safety, as well as for other quality attributes, requires an effective certification and tracking of these attributes as well as their communication to buyers. Several challenges must be met if labeling, particularly consumer labeling, is to support the development of markets for improved seafood safety.

  9. Blood Clots (United States)

    ... or prevent blood clots from dissolving properly. Risk factors for excessive blood clotting include Certain genetic disorders Atherosclerosis Diabetes Atrial fibrillation Overweight, obesity, and metabolic syndrome Some medicines Smoking deep vein ...

  10. Blood Transfusion (United States)

    ... to their work or home. The availability of plastic bags that can have one or more satellite bags ... in preparing the donated blood. The use of plastic bags allows the blood center to make a variety ...

  11. Analysis of the organization implemented by a nuclear operator for ensuring the safety of his facilities: contribution of case studies; Analyse de l'organisation mise en place par un exploitant nucleaire pour assurer la surete de ses installations: l'apport des etudes de cas

    Energy Technology Data Exchange (ETDEWEB)

    Jeffroy, F.; Conte, D. [Institut de Radioprotection et de Surete Nucleaire (IRSN), 92 - Clamart (France)


    This article is the chapter 6 of this book. It deals with the organization implemented by a nuclear operator and its suitability in warranting the safety of his facilities. An analysis approach has been defined which takes into consideration the formal aspect of the rules, structures and resources implemented by the organization, and which considers also the operational aspect through the collective activity of actors. The operation dynamics of the organisation has been approached through retrospective case studies aiming at understanding, from actors' contributions to the processing of events, how the characteristics of the organization were representing resources or constraints for the actors. This approach of organization through case studies must be put forward in the present day debate about cognitive ergonomics in sociology of organizations and in management. Several works try to put in relation the activity of 'front line' actors with the decisions and orientations taken at the strategic level. This supposes that one can combine an analysis of actors' activity integrating their point of view and and analysis of the structures and resources that are supplied to them by the organization. (J.S.)

  12. Analysis of the organisation implemented by a nuclear operator to carry out the safety of his installations: contribution of cases study; Analyse de l'organisation mise en place par un exploitant nucleaire pour assurer la surete de ses installations: l'apport des etudes de cas

    Energy Technology Data Exchange (ETDEWEB)

    Jeffroy, F.; Conte, D. [Institut de Radioprotection et de Surete Nucleaire (IRSN), 92 - Clamart (France); Boel, M. [Bertin Technologies, 78 - Montigny-le-Bretonneux (France)


    Sought to estimate if the organization implemented by a nuclear operator allowed him to provide the safety of its installations, we defined a step of analysis which approaches the organization on the formal plan of rules, structures and implemented resources, and on that one of its functioning understood through the actors collective activity. The functioning dynamics of the organization was approached from retrospective studies of case aiming to understand, from the actors contributions in the treatment of an event, the way whom the organization characteristics established resources or constraints for the actors. This approach of the organization through case studies, seems to us to have to be replaced in the debate opened at present in cognitive ergonomics, in sociology of organizations and in management. Numerous works indeed try to put in relation the activity of the 'first-line actors' and the decisions and the orientations taken at the strategic level, what supposes to be capable of articulating an analysis of the actors activity. (N.C.)


    CERN Multimedia

    TIS Secretariat


    Please note that the SAFETY INSTRUCTION N0 49 (IS 49) and the SAFETY NOTE N0 28 (NS 28) entitled respectively 'AVOIDING CHEMICAL POLLUTION OF WATER' and 'CERN EXHIBITIONS - FIRE PRECAUTIONS' are available on the web at the following urls: and Paper copies can also be obtained from the TIS Divisional Secretariat, email:

  14. Quality Assurance in the European Higher Education Area: The Emergence of a German Market for Quality Assurance Agencies (United States)

    Serrano-Velarde, Kathia E.


    Most European countries have introduced systematic quality assurance as part of an overall governance reform aimed at enhancing universities' autonomy. Researchers and economic entrepreneurs tend, however, to underestimate the political dimension of accreditation and evaluation when they consider the contribution of quality assurance to the…

  15. Assurance of operate reliability of rolling stock

    Institute of Scientific and Technical Information of China (English)

    Gubacheva; L.A.; Naish; N.; M.


    The safety of movement of rolling stock is mainly related to operate reliability of conjugated parts of running carriages which are characterized by their ability of no failure operation in complex conditions of service and have a sufficient high strength and wear resistance.……

  16. Assurance of operate reliability of rolling stock

    Institute of Scientific and Technical Information of China (English)


    @@ The safety of movement of rolling stock is mainly related to operate reliability of conjugated parts of running carriages which are characterized by their ability of no failure operation in complex conditions of service and have a sufficient high strength and wear resistance.

  17. Blood Facts and Statistics (United States)

    ... Facts and Statistics Printable Version Blood Facts and Statistics Facts about blood needs Facts about the blood ... to Top Learn About Blood Blood Facts and Statistics Blood Components Whole Blood and Red Blood Cells ...

  18. Quality-assurance and data management plan for groundwater activities by the U.S. Geological Survey in Kansas, 2014 (United States)

    Putnam, James E.; Hansen, Cristi V.


    As the Nation’s principle earth-science information agency, the U.S. Geological Survey (USGS) is depended on to collect data of the highest quality. This document is a quality-assurance plan for groundwater activities (GWQAP) of the Kansas Water Science Center. The purpose of this GWQAP is to establish a minimum set of guidelines and practices to be used by the Kansas Water Science Center to ensure quality in groundwater activities. Included within these practices are the assignment of responsibilities for implementing quality-assurance activities in the Kansas Water Science Center and establishment of review procedures needed to ensure the technical quality and reliability of the groundwater products. In addition, this GWQAP is intended to complement quality-assurance plans for surface-water and water-quality activities and similar plans for the Kansas Water Science Center and general project activities throughout the USGS. This document provides the framework for collecting, analyzing, and reporting groundwater data that are quality assured and quality controlled. This GWQAP presents policies directing the collection, processing, analysis, storage, review, and publication of groundwater data. In addition, policies related to organizational responsibilities, training, project planning, and safety are presented. These policies and practices pertain to all groundwater activities conducted by the Kansas Water Science Center, including data-collection programs, interpretive and research projects. This report also includes the data management plan that describes the progression of data management from data collection to archiving and publication.

  19. Mobility Network and Safety

    Directory of Open Access Journals (Sweden)

    Adriana Galderisi


    Full Text Available Mobility network is crucial for ensuring territorial safety with respect to natural and technological hazards. They represent a basic support to community’s everyday life although being exposed elements often characterized by high vulnerability to different hazards and, in the meanwhile, strategic equipments for emergency management. Physical damages or the lack in functioning of those networks may greatly increase the loss of human lives caused by hazardous events as well as produce relevant economic damages at medium and long term. Although the relevance of the mobility networks in assuring territorial safety is at present largely recognized, risk analyses have been long focused on buildings’ vulnerability or, even where they have paid attention to mobility network, they have been mainly focused on the physical damages that a given hazard could may induce on individual elements of such network. It is recent the awareness that mobility network represents a system, characterized by relevant interdependences both among its elements and among network infrastructures and urban systems. Based on these assumptions, this paper points out the heterogeneous aspects of the mobility network vulnerability and their relevance in increasing the overall territorial or urban vulnerability to hazardous events. Therefore, an in-depth investigation of the concept of mobility network vulnerability is provided, in order to highlight the aspects mostly investigated and more recent research perspectives. Finally, a case study in the Campania Region is presented in order to point out how traditional risk analyses, generally referred to individual hazards, can sometimes led to invest in the mobility network improvement or development which, targeted to increase the security of a territory result, on the opposite, in an increase of the territorial vulnerability.

  20. First Aid and Safety (United States)

    ... Playground Safety Preventing Children's Sports Injuries Safety Tips: Baseball Safety Tips: Basketball Safety Tips: Hockey Safety Tips: ... it a Medical Emergency? Knowing Your Child's Medical History Nosebleeds Seizures Serious Allergic Reactions (Anaphylaxis) Teaching Your ...

  1. Cord Blood

    Directory of Open Access Journals (Sweden)

    Saeed Abroun


    Full Text Available   Stem cells are naïve or master cells. This means they can transform into special 200 cell types as needed by body, and each of these cells has just one function. Stem cells are found in many parts of the human body, although some sources have richer concentrations than others. Some excellent sources of stem cells, such as bone marrow, peripheral blood, cord blood, other tissue stem cells and human embryos, which last one are controversial and their use can be illegal in some countries. Cord blood is a sample of blood taken from a newborn baby's umbilical cord. It is a rich source of stem cells, umbilical cord blood and tissue are collected from material that normally has no use following a child’s birth. Umbilical cord blood and tissue cells are rich sources of stem cells, which have been used in the treatment of over 80 diseases including leukemia, lymphoma and anemia as bone marrow stem cell potency.  The most common disease category has been leukemia. The next largest group is inherited diseases. Patients with lymphoma, myelodysplasia and severe aplastic anemia have also been successfully transplanted with cord blood. Cord blood is obtained by syringing out the placenta through the umbilical cord at the time of childbirth, after the cord has been detached from the newborn. Collecting stem cells from umbilical blood and tissue is ethical, pain-free, safe and simple. When they are needed to treat your child later in life, there will be no rejection or incompatibility issues, as the procedure will be using their own cells. In contrast, stem cells from donors do have these potential problems. By consider about cord blood potency, cord blood banks (familial or public were established. In IRAN, four cord blood banks has activity, Shariati BMT center cord blood bank, Royan familial cord blood banks, Royan public cord blood banks and Iranian Blood Transfusion Organ cord blood banks. Despite 50,000 sample which storage in these banks, but the

  2. Preventing Blood Clots After Orthopaedic Surgery

    Medline Plus

    Full Text Available ... Bones & Injuries Diseases & Conditions Arthritis Tumors Sports Injuries & Prevention Children Bone Health Health & Safety Treatment Treatments & Surgeries ... Your doctor will outline a program to help prevent the development of blood clots after your surgery. ...

  3. The role of gap analyses in energy assurance planning. (United States)

    Shea, Katherine


    Energy-related emergencies, such as power outages or interruptions to other energy supplies, can arise from a number of factors. Common causes include severe weather events--such as snowstorms, hurricanes, or summer storms with strong winds--as well as energy infrastructure that is overburdened, aging, or in need of repair. As past experience indicates, jurisdictions will continue to experience severe weather events, as well as confront infrastructure issues that make future power outages likely. As a result, state and local governments have turned to energy assurance planning, an energy-specific form of planning that helps jurisdictions prepare for and recover from energy emergencies. Energy assurance recognizes that power loss/disruption cannot be eradicated completely, but jurisdictions can mitigate the impact of power loss through effective planning. This article discusses the role of energy assurance planning and provides a description of what energy assurance means and why developing such plans at the state and local levels is important. In addition, this article discusses the role of statutory gap analyses in energy assurance planning and discusses how a gap analysis can be used by planners to identify trends and gaps in energy assurance. To provide context, a recently conducted statutory gap analysis analyzing national emergency backup power trends is provided as a case study. A summary of this project and key findings is included. Finally, this article briefly touches on legislation as an alternative to energy assurance planning, and provides summaries of recent legislative proposals introduced in the aftermath of Hurricane Sandy.

  4. The Columbia River Protection Supplemental Technologies Quality Assurance Project Plan

    Energy Technology Data Exchange (ETDEWEB)

    Fix, N. J.


    The U.S. Department of Energy (DOE) has conducted interim groundwater remedial activities on the Hanford Site since the mid-1990s for several groundwater contamination plumes. DOE established the Columbia River Protection Supplemental Technologies Project (Technologies Project) in 2006 to evaluate alternative treatment technologies. The objectives for the technology project are as follows: develop a 300 Area polyphosphate treatability test to immobilize uranium, design and test infiltration of a phosphate/apatite technology for Sr-90 at 100-N, perform carbon tetrachloride and chloroform attenuation parameter studies, perform vadose zone chromium characterization and geochemistry studies, perform in situ biostimulation of chromium studies for a reducing barrier at 100-D, and perform a treatability test for phytoremediation for Sr-90 at 100-N. This document provides the quality assurance guidelines that will be followed by the Technologies Project. This Quality Assurance Project Plan is based on the quality assurance requirements of DOE Order 414.1C, Quality Assurance, and 10 CFR 830, Subpart A--Quality Assurance Requirements as delineated in Pacific Northwest National Laboratory’s Standards-Based Management System. In addition, the technology project is subject to the Environmental Protection Agency (EPA) Requirements for Quality Assurance Project Plans (EPA/240/B-01/003, QA/R-5). The Hanford Analytical Services Quality Assurance Requirements Documents (HASQARD, DOE/RL-96-68) apply to portions of this project and to the subcontractors. HASQARD requirements are discussed within applicable sections of this plan.


    Directory of Open Access Journals (Sweden)

    Latika Kharb


    Full Text Available Component-based software engineering (CBSE / Component-Based Development (CBD lays emphasis on decomposition of the engineered systems into functional or logical components with well-defined interfaces used for communication across the components. Component-based software development approach is based on the idea to develop software systems by selecting appropriate off-the-shelf components and then to assemble them with a well-defined software architecture. Because the new software development paradigm is much different from the traditional approach, quality assurance for component-based software development is a new topic in the software engineering research community. Because component-based software systems are developed on an underlying process different from that of the traditional software, their quality assurance model should address both the process of components and the process of the overall system. Quality assurance for component-based software systems during the life cycle is used to analyze the components for achievement of high quality component-based software systems. Although some Quality assurance techniques and component based approach to software engineering have been studied, there is still no clear and well-defined standard or guidelines for component-based software systems. Therefore, identification of the quality assurance characteristics, quality assurance models, quality assurance tools and quality assurance metrics, are under urgent need. As a major contribution in this paper, I have proposed QAM: Quality Assurance Model for component-based software development, which covers component requirement analysis, component development, component certification, component architecture design, integration, testing, and maintenance.

  6. 75 FR 5154 - Assurant, Inc., et al.; Notice of Application and Temporary Order (United States)


    ... reinsurance contract. The Complaint alleged that Assurant violated the corporate reporting, recordkeeping, and... public reporting practices. The Complaint related to Assurant's inaccurate recording of income for...

  7. Assurance Technology Challenges of Advanced Space Systems (United States)

    Chern, E. James


    The initiative to explore space and extend a human presence across our solar system to revisit the moon and Mars post enormous technological challenges to the nation's space agency and aerospace industry. Key areas of technology development needs to enable the endeavor include advanced materials, structures and mechanisms; micro/nano sensors and detectors; power generation, storage and management; advanced thermal and cryogenic control; guidance, navigation and control; command and data handling; advanced propulsion; advanced communication; on-board processing; advanced information technology systems; modular and reconfigurable systems; precision formation flying; solar sails; distributed observing systems; space robotics; and etc. Quality assurance concerns such as functional performance, structural integrity, radiation tolerance, health monitoring, diagnosis, maintenance, calibration, and initialization can affect the performance of systems and subsystems. It is thus imperative to employ innovative nondestructive evaluation methodologies to ensure quality and integrity of advanced space systems. Advancements in integrated multi-functional sensor systems, autonomous inspection approaches, distributed embedded sensors, roaming inspectors, and shape adaptive sensors are sought. Concepts in computational models for signal processing and data interpretation to establish quantitative characterization and event determination are also of interest. Prospective evaluation technologies include ultrasonics, laser ultrasonics, optics and fiber optics, shearography, video optics and metrology, thermography, electromagnetics, acoustic emission, x-ray, data management, biomimetics, and nano-scale sensing approaches for structural health monitoring.

  8. Quality Assurance Program for Molecular Medicine Laboratories

    Directory of Open Access Journals (Sweden)

    F Sabzavi


    Full Text Available Background: Molecular diagnostic methods have played and continuing to have a critical role in clinical laboratories in recent years. Therefore, standardization is an evolutionary process that needs to be upgrade with increasing scientific knowledge, improvement of the instruments and techniques. The aim of this study was to design a quality assurance program in order to have similar conditions for all medical laboratories engaging with molecular tests.Methods: We had to design a plan for all four elements; required space conditions, equipments, training, and basic guidelines. Necessary guidelines was prepared and confirmed by the launched specific committee at the Health Reference Laboratory.Results: Several workshops were also held for medical laboratories directors and staffs, quality control manager of molecular companies, directors and nominees from universities. Accreditation of equipments and molecular material was followed parallel with rest of program. Now we are going to accredit medical laboratories and to evaluate the success of the program.Conclusion: Accreditation of medical laboratory will be succeeding if its basic elements are provided in advance. Professional practice guidelines, holding training and performing accreditation the molecular materials and equipments ensured us that laboratories are aware of best practices, proper interpretation, limitations of techniques, and technical issues. Now, active external auditing can improve the applied laboratory conditions toward the defined standard level.

  9. QART - the CERN facility for quality assurance

    CERN Multimedia

    Katarina Anthony


    How would your detector perform in a very high magnetic field? Or at 60°C and high humidity? Will it work for 10 or more years? Answering these questions requires specialised and thorough testing. This can be done at the Quality Assurance and Reliability Testing Laboratory (QART) - a top-notch testing facility based at CERN, providing invaluable support for CERN projects. The QART lab has become a service in 2011, and invites all projects to use its equipment and expertise.   A portable high-sensitivity infra-red thermal imaging video camera (top left) is used to observe the thermal profile of a silicon strip sensor (top right). The thermal images taken before (bottom left) and after (bottom right) applying voltage to the device clearly show a hot spot developing on the sensor, indicating a serious defect. The infra-red camera is an example of the variety of sophisticated equipment in the QART lab available to CERN projects for the analysis of problems and enviro...

  10. Are Thai consumers willing to pay for food safety labels? Choice experiment on fresh produce


    Wongprawmas, Rungsaran; Canavari, Maurizio; Waisarayutt, Chutima


    Thai government introduced a food safety label (Q mark) to help consumers recognizing produce with higher level of safety assurance. Producers and retailers are sceptical on whether Thai consumers place value on it, thus they are reluctant to apply to obtain certification and label. This study aims to estimate the value Thai consumers place on food safety labels for fresh produce using a discrete choice experiment approach and a mixed logit (RPL) model. A sample of 350 Thai consumers was surv...

  11. Quality assurance for image-guided radiation therapy utilizing CT-based technologies: A report of the AAPM TG-179

    Energy Technology Data Exchange (ETDEWEB)

    Bissonnette, Jean-Pierre; Balter, Peter A.; Dong Lei; Langen, Katja M.; Lovelock, D. Michael; Miften, Moyed; Moseley, Douglas J.; Pouliot, Jean; Sonke, Jan-Jakob; Yoo, Sua [Task Group 179, Department of Radiation Physics, Princess Margaret Hospital, University of Toronto, Toronto, Ontario, M5G 2M9 (Canada); Department of Radiation Physics, University of Texas M.D. Anderson Cancer Center, Houston, Texas 77030 (United States); Department of Radiation Oncology, M. D. Anderson Cancer Center Orlando, Orlando, Florida 32806 (United States); Department of Medical Physics, Memorial Sloan-Kettering Cancer Center, New York, New York 10021 (United States); Department of Radiation Oncology, University of Colorado School of Medicine, Aurora, Colorado 80045 (United States); Department of Radiation Physics, Princess Margaret Hospital, University of Toronto, Toronto, Ontario, M5G 2M9 (Canada); Department of Radiation Oncology, UCSF Comprehensive Cancer Center, 1600 Divisadero St., Suite H 1031, San Francisco, California 94143-1708 (United States); Department of Radiation Oncology, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX Amsterdam (Netherlands); Department of Radiation Oncology, Duke University, Durham, North Carolina 27710 (United States)


    Purpose: Commercial CT-based image-guided radiotherapy (IGRT) systems allow widespread management of geometric variations in patient setup and internal organ motion. This document provides consensus recommendations for quality assurance protocols that ensure patient safety and patient treatment fidelity for such systems. Methods: The AAPM TG-179 reviews clinical implementation and quality assurance aspects for commercially available CT-based IGRT, each with their unique capabilities and underlying physics. The systems described are kilovolt and megavolt cone-beam CT, fan-beam MVCT, and CT-on-rails. A summary of the literature describing current clinical usage is also provided. Results: This report proposes a generic quality assurance program for CT-based IGRT systems in an effort to provide a vendor-independent program for clinical users. Published data from long-term, repeated quality control tests form the basis of the proposed test frequencies and tolerances.Conclusion: A program for quality control of CT-based image-guidance systems has been produced, with focus on geometry, image quality, image dose, system operation, and safety. Agreement and clarification with respect to reports from the AAPM TG-101, TG-104, TG-142, and TG-148 has been addressed.

  12. Fast reactor safety program. Progress report, January-March 1980

    Energy Technology Data Exchange (ETDEWEB)



    The goal of the DOE LMFBR Safety Program is to provide a technology base fully responsive to safety considerations in the design, evaluation, licensing, and economic optimization of LMFBRs for electrical power generation. A strategy is presented that divides safety technology development into seven program elements, which have been used as the basis for the Work Breakdown Structure (WBS) for the Program. These elements include four lines of assurance (LOAs) involving core-related safety considerations, an element supporting non-core-related plant safety considerations, a safety R and D integration element, and an element for the development of test facilities and equipment to be used in Program experiments: LOA-1 (prevent accidents); LOA-2 (limit core damage); LOA-3 (maintain containment integrity); LOA-4 (attenuate radiological consequences); plant considerations; R and D integration; and facility development.

  13. Integrated Environment for Development and Assurance (United States)


    FMEA •Hazard analysis Real-time Performance •Execution time/ Deadline •Deadlock/starvation •Latency Resource Consumption •Bandwidth •CPU time •Power...Mechatronics: Actuator & Wings Safety Analysis (FHA, FMEA ) Reliability Analysis (MTTF) Aircraft system: (Tier 1) Engine, Landing Gear, Cockpit...System Component Subsystem Capture FMEA model Capture hazards Capture risk mitigation architecture Error Model Annex can be adapted to other ADLs 26

  14. System Safety in an IT Service Organization (United States)

    Parsons, Mike; Scutt, Simon

    Within Logica UK, over 30 IT service projects are considered safetyrelated. These include operational IT services for airports, railway infrastructure asset management, nationwide radiation monitoring and hospital medical records services. A recent internal audit examined the processes and documents used to manage system safety on these services and made a series of recommendations for improvement. This paper looks at the changes and the challenges to introducing them, especially where the service is provided by multiple units supporting both safety and non-safety related services from multiple locations around the world. The recommendations include improvements to service agreements, improved process definitions, routine safety assessment of changes, enhanced call logging, improved staff competency and training, and increased safety awareness. Progress is reported as of today, together with a road map for implementation of the improvements to the service safety management system. A proposal for service assurance levels (SALs) is discussed as a way forward to cover the wide variety of services and associated safety risks.

  15. Idaho National Laboratory Emergency Readiness Assurance Plan - Fiscal Year 2015

    Energy Technology Data Exchange (ETDEWEB)

    Farmer, Carl J. [Idaho National Lab. (INL), Idaho Falls, ID (United States)


    Department of Energy Order 151.1C, Comprehensive Emergency Management System requires that each Department of Energy field element documents readiness assurance activities, addressing emergency response planning and preparedness. Battelle Energy Alliance, LLC, as prime contractor at the Idaho National Laboratory (INL), has compiled this Emergency Readiness Assurance Plan to provide this assurance to the Department of Energy Idaho Operations Office. Stated emergency capabilities at the INL are sufficient to implement emergency plans. Summary tables augment descriptive paragraphs to provide easy access to data. Additionally, the plan furnishes budgeting, personnel, and planning forecasts for the next 5 years.

  16. Quality Assurance Tests of the CMS Endcap RPCs

    CERN Document Server

    Ahmed, Ijaz; Hamid Ansari, M; Irfan Asghar, M; Asghar, Sajjad; Awan, Irfan Ullah; Butt, Jamila; Hoorani, Hafeez R; Hussain, Ishtiaq; Khurshid, Taimoor; Muhammad, Saleh; Shahzad, Hassan; Aftab, Zia; Iftikhar, Mian; Khan, Mohammad Khalid; Saleh, M


    In this note, we have described the quality assurance tests performed for endcap Resistive Plate Chambers (RPCs) at two different sites, Pakistan Atomic Energy Commission (PAEC) and National Centre for Physics (NCP), in Pakistan. This paper describes various quality assurance tests both at the level of gas gaps and the chambers. The data has been obtained at different time windows during the large scale production of CMS RPCs of RE2/2 and RE2/3 type. In the quality assurance tests, we have investigated parameters like dark current, strip occupancy, cluster size and efficiency of RPCs.

  17. Flow logic for language-based safety and security

    DEFF Research Database (Denmark)

    Hansen, René Rydhof


    Society is increasingly dependent on information and communication technology. Computers are integrated into everything from toasters to control systems for critical infrastructure. Consequently even simple programming errors have the potential to wreck havoc on practically every aspect of society......-based safety and security, provide a feasible platform for developing software that can be verified and validated with a very high degree of assurance. Specifically, it is argued and demonstrated that static analysis is an indispensable technique for language- based safety and security and that the Flow Logic...... with respect to the semantics and are then used to verify a wide spectrum of pertinent safety and security properties....


    CERN Multimedia

    TIS Secretariat


    Please note that the Safety Bulletin no 4 (TIS 2002-04) entitled 'KNOW THE RISKS' is available on the web. Paper copies can also be obtained from the TIS Divisional Secretariat, e-mail: TIS Secretariat

  19. Safety Resources. (United States)

    Hoot, James L.; Bartkowiak, Elaine T.


    Lists 72 organizations and programs that deal with child safety, grouped by the following categories: (1) general; (2) general violence; (3) gun violence; (4) media violence; (5) drugs and alcohol; (6) child abuse and at-risk children; (7) parenting programs; (8) community service programs; (9) leadership programs; (10) peer counseling; (11)…

  20. Recent advances in systems safety and security

    CERN Document Server

    Stamatescu, Grigore


    This book represents a timely overview of advances in systems safety and security, based on selected, revised and extended contributions from the 2nd and 3rd editions of the International Workshop on Systems Safety and Security – IWSSS, held in 2014 and 2015, respectively, in Bucharest, Romania. It includes 14 chapters, co-authored by 34 researchers from 7 countries. The book provides an useful reference from both theoretical and applied perspectives in what concerns recent progress in this area of critical interest. Contributions, broadly grouped by core topic, address challenges related to information theoretic methods for assuring systems safety and security, cloud-based solutions, image processing approaches, distributed sensor networks and legal or risk analysis viewpoints. These are mostly accompanied by associated case studies providing additional practical value and underlying the broad relevance and impact of the field.