Science.gov

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.

    PubMed

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

    2013-11-01

    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

    NASA Technical Reports Server (NTRS)

    Kelly, Michael P.

    2010-01-01

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

  3. Safety and Mission Assurance: A NASA Perspective

    NASA Technical Reports Server (NTRS)

    Higginbotham, Scott Alan

    2011-01-01

    Safety and Mission Assurance (S&MA) consists of the safety, reliability, maintainability, software assurance and quality disciplines, which are applied to reduce the probability of mishaps and ensure mission success. NASA uses a risk management process which requires various organizations to identify, analyze and mitigate/control risks associated with operations and decision making processes.

  4. Safety assurance of complex integrated systems

    NASA Technical Reports Server (NTRS)

    Abrignani, Vincent A.; Jordan, John R.

    1991-01-01

    Interface hazard analysis (IHA) is used as a 'tool' to systematically assess safety for the integration of a diverse set of experiments and payload hardware into the Spacelab carrier which flies in the Space Shuttle's Orbiter cargo bay. The IHA when performed by a thorough analysis provides safety assurance of complex integrated systems by systematically linking analysis efforts performed by the organizations thus providing the respective elements to be integrated into an objective, unique analysis. Particular attention is given to verification methods of the safety assurance of the Spacelab carrier and its experiment payload for which the IHA was performed.

  5. Globalisation and blood safety.

    PubMed

    Farrugia, Albert

    2009-05-01

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

  6. Assuring NASA's Safety and Mission Critical Software

    NASA Technical Reports Server (NTRS)

    Deadrick, Wesley

    2015-01-01

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

  7. Software Safety Assurance of Programmable Logic

    NASA Technical Reports Server (NTRS)

    Berens, Kalynnda

    2002-01-01

    Programmable Logic (PLC, FPGA, ASIC) devices are hybrids - hardware devices that are designed and programmed like software. As such, they fall in an assurance gray area. Programmable Logic is usually tested and verified as hardware, and the software aspects are ignored, potentially leading to safety or mission success concerns. The objective of this proposal is to first determine where and how Programmable Logic (PL) is used within NASA and document the current methods of assurance. Once that is known, raise awareness of the PL software aspects within the NASA engineering community and provide guidance for the use and assurance of PL form a software perspective.

  8. Safety and Mission Assurance Performance Metric

    NASA Technical Reports Server (NTRS)

    Holsomback, Jerry; Kuo, Fred; Wade, Jim

    2005-01-01

    The safety and mission assurance (S&MA) performance metric is a method that provides a process through which the managers of a large, complex program can readily understand and assess the accepted risk, the problems, and the associated reliability of the program. Conceived for original use in helping to assure the safety and success of the International Space Station (ISS) program, the S&MA performance metric also can be applied to other large and complex programs and projects. The S&MA-performance-metric data products comprise one or more tables (possibly also one or more graphs) that succinctly display all of the information relevant (and no information that is irrelevant) to management decisions that must be made to assure the safety and success of a program or project, thereby facilitating such decisions.

  9. Safety Assurance in NextGen

    NASA Technical Reports Server (NTRS)

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

    2012-01-01

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

  10. Dynamic Safety Cases for Through-Life Safety Assurance

    NASA Technical Reports Server (NTRS)

    Denney, Ewen; Pai, Ganesh; Habli, Ibrahim

    2015-01-01

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

  11. 71 FR 76729 - New Entrant Safety Assurance Process

    Federal Register 2010, 2011, 2012, 2013, 2014

    2006-12-21

    ... Parts 365, 385, 387, and 390 RIN 2126-AA59 New Entrant Safety Assurance Process AGENCY: Federal Motor... comments. SUMMARY: FMCSA proposes changes to the New Entrant Safety Assurance Process that would raise the... proposes changes to the New Entrant Safety Assurance Process to improve the agency's ability to identify...

  12. 73 FR 76471 - New Entrant Safety Assurance Process

    Federal Register 2010, 2011, 2012, 2013, 2014

    2008-12-16

    ... CFR Parts 365, 385, 387, and 390 RIN 2126-AA59 New Entrant Safety Assurance Process AGENCY: Federal... MCSIA, FMCSA published an interim final rule (IFR) titled New Entrant Safety Assurance Process (67 FR... entrants are subject to the New Entrant Safety Assurance Process. Mexico-domiciled new entrants are...

  13. Safety and Mission Assurance Knowledge Management Retention

    NASA Technical Reports Server (NTRS)

    Johnson, Teresa A.

    2006-01-01

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

  14. Integrating Safety and Mission Assurance in Design

    NASA Technical Reports Server (NTRS)

    Cianciola, Chris; Crane, Kenneth

    2008-01-01

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

  15. 78 FR 54510 - New Entrant Safety Assurance Program Operational Test

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-04

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

  16. 67 FR 31978 - New Entrant Safety Assurance Process

    Federal Register 2010, 2011, 2012, 2013, 2014

    2002-05-13

    ... Federal Motor Carrier Safety Administration 49 CFR Part 385 RIN 2126-AA59 New Entrant Safety Assurance Process AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Interim Final Rule (IFR... public and congressional interest in the new entrant safety assurance process. OMB has designated...

  17. Office of Safety and Mission Assurance Review Report

    NASA Technical Reports Server (NTRS)

    2000-01-01

    This document summarizes questions and concerns raised during the 1999 IV&V Facility's Annual Review Presentation to the Office of Safety and Mission Assurance (OSMA). Recommendations are provided for issues and action items identified.

  18. [Innovative technology and blood safety].

    PubMed

    Begue, S; Morel, P; Djoudi, R

    2016-11-01

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

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

    NASA Technical Reports Server (NTRS)

    Malone, Roy W.; Safie, Fayssal M.

    2010-01-01

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

  20. TOPAZ-2 Nuclear Power System safety assurance

    SciTech Connect

    Nikitin, V.P.; Ogloblin, B.G.; Lutov, Y.I.; Luppov, A.N.; Shalaev, A.I. ); Ponomarev-Stepnoi, N.N.; Usov, V.A.; Nechaev, Y.A. )

    1993-01-15

    TOPAZ-2 Nuclear Power System (NPS) safety philosophy is based on the requirement that the reactor shall not be critical during all kinds of operations prior to its start-up on the safe orbit (except for physical start-up). Potentially dangerous operation were analyzed and both computational and experimental studies were carried out.

  1. Safety and Mission Assurance: A NASA Perspective

    NASA Technical Reports Server (NTRS)

    Higginbotham, Scott A.

    2016-01-01

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

  2. [Assuring food safety and nutritional quality].

    PubMed

    E, Alonzo; V, Pontieri; V, Cannizzaro; R, La Carrubba; P, Pisana; M, Raiti; M, Fardella

    2014-01-01

    Nutrition needs increasingly integration between Food Safety and Nutritional Prevention, duties, in Italy, since I 998 the Food Hygiene and Nutrition services (SIAN) do. Furthermore, working in Evidence Based Prevention (EBP) is necessary to improve the prevention and make it more useful to people health, so it must be used tested efficacy methods, above all in a unsuitable economic and human sources contest. In order to improve the prevention and working in EBP, SIAN have devised and achieved some Nutritional Prevention Projects, interregional, regional and local wide net-working, by using process and efficacy indicators, in some projects also user's satisfaction indicators are used. Project's results will be used to work in EBP ever more in order to improve the prevention and make it repeatable and sustainable to prevent the gradual and constant increase of chronic-degenerative diseases an consequently health costs.

  3. Viral metagenomics and blood safety.

    PubMed

    Sauvage, V; Eloit, M

    2016-02-01

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

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

    PubMed

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

    2004-01-01

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

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

    NASA Technical Reports Server (NTRS)

    Malone, Roy W., Jr.

    2010-01-01

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

  6. Assuring fish safety and quality in international fish trade.

    PubMed

    Ababouch, Lahsen

    2006-01-01

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

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

    SciTech Connect

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

    1982-01-01

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

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

    PubMed

    Westmoreland, Carl; Holmes, Anthony M

    2009-04-01

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

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

    NASA Technical Reports Server (NTRS)

    Beckman, Sean; Darpel, Scott

    2015-01-01

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

  10. Cascade Distillation System Design for Safety and Mission Assurance

    NASA Technical Reports Server (NTRS)

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

    2015-01-01

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

  11. Cascade Distillation System Design for Safety and Mission Assurance

    NASA Technical Reports Server (NTRS)

    Sargusingh, Miriam J.; Callahan, Michael R.

    2015-01-01

    Per the NASA Human Health, Life Support and Habitation System Technology Area 06 report "crewed missions venturing beyond Low-Earth Orbit (LEO) will require technologies with improved reliability, reduced mass, self-sufficiency, and minimal logistical needs as an emergency or quick-return option will not be feasible." To meet this need, the development team of the second generation Cascade Distillation System (CDS 2.0) opted a development approach that explicitely incorporate consideration of safety, mission assurance, and autonomy. The CDS 2.0 prelimnary 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 mitigative 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.

  12. SAFEGUARD: An Assured Safety Net Technology for UAS

    NASA Technical Reports Server (NTRS)

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

    2016-01-01

    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.

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

    NASA Technical Reports Server (NTRS)

    Wetherholt, Martha

    2016-01-01

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

  14. Safety and mission assurance in a better, faster, cheaper environment

    NASA Astrophysics Data System (ADS)

    Gregory, Frederick D.

    1996-09-01

    To provide the American people with an exciting aeronautics and space program that provides more tangible value in products and services and more relevance to the public, NASA has developed a philosophy that emphasizes better, faster, and cheaper ways of conducting business. The integration of safety, reliability and quality assurance (SR&QA) products and services into all NASA's programs and projects, from beginning to end, and the implementation of progressive quality management and contracting practices are direct applications of this philosophy. NASA's new test effectiveness program integrates the oribital performance and reliability experience of prior spacecraft with new design processes and improved telemetry to achieve higher performance and reliability, faster, and at reduced cost. As United States government leaders for ISO 9000 implementation, NASA is promoting single quality systems for contractors, the use of advanced quality practices, and methods for the implementation of baseline quality systems with the appropriate oversight to further low cost, high performance programs in the future. To remain vital in today's era of fiscal constraint, NASA must be efficient, effective, and relevant. The innovative integration and application of SR&QA tools, techniques, and management approaches in all NASA's programs and projects will play an integral role in achieving this end.

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

    PubMed

    Nakhleh, Raouf E

    2015-06-01

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

  16. 30 CFR 250.806 - Safety and pollution prevention equipment quality assurance requirements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 2 2011-07-01 2011-07-01 false Safety and pollution prevention equipment quality assurance requirements. 250.806 Section 250.806 Mineral Resources BUREAU OF OCEAN ENERGY... pollution prevention equipment quality assurance requirements. (a) General requirements. (1) Except...

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

    NASA Technical Reports Server (NTRS)

    2002-01-01

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

  18. Assuring Safety in Bus Transportation--Update on Federal Legislation.

    ERIC Educational Resources Information Center

    Craft, Nick

    2003-01-01

    Discusses the growing use of vans for transportation by child care centers and increasing concerns about van safety. Presents information on relevant federal legislation related to motor vehicle safety and the safety standards of the National Highway Traffic Safety Administration. Recommends that child care programs replace retiring vans with…

  19. Assure

    Integrated Risk Information System (IRIS)

    Assure ; CASRN 76578 - 14 - 8 Human health assessment information on a chemical substance is included in the IRIS database only after a comprehensive review of toxicity data , as outlined in the IRIS assessment development process . Sections I ( Health Hazard Assessments for Noncarcinogenic Effects

  20. Blood transfusion safety: a new philosophy.

    PubMed

    Franklin, I M

    2012-12-01

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

  1. 74 FR 42833 - New Entrant Safety Assurance Process: Implementation of Section 210(b) of the Motor Carrier...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2009-08-25

    ... Process: Implementation of Section 210(b) of the Motor Carrier Safety Improvement Act of 1999 AGENCY... Entrant Safety Assurance Process and seek information concerning issues that should be considered in the... published an interim final rule (IFR) titled ``New Entrant Safety Assurance Process'' (67 FR 31978),...

  2. Management of National Nuclear Power Programs for assured safety

    SciTech Connect

    Connolly, T.J.

    1985-01-01

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

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

    PubMed

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

    2014-11-01

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

  4. Safety Assurances at Space Test Centres: Lessons Learned

    NASA Astrophysics Data System (ADS)

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

    2010-09-01

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

  5. Challenges of assuring crew safety in space shuttle missions with international cargoes.

    PubMed

    Vongsouthy, C; Stenger-Nguyen, P A; Nguyen, H V; Nguyen, P H; Huang, M C; Alexander, R G

    2004-02-01

    The top priority in America's manned space flight program is the assurance of crew and vehicle safety. This priority gained greater focus during and after the Space Shuttle return-to-flight mission (STS-26). One of the interesting challenges has been to assure crew safety and adequate protection of the Space Shuttle, as a national resource, from increasingly diverse cargoes and operations. The control of hazards associated with the deployment of complex payloads and cargoes has involved many international participants. These challenges are examined in some detail along with examples of how crew safety has evolved in the manned space program and how the international partners have addressed various scenarios involving control and mitigation of potential hazards to crew and vehicle safety.

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

    NASA Astrophysics Data System (ADS)

    Malone, Roy W.; Livingston, John M.

    2010-09-01

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

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

    NASA Technical Reports Server (NTRS)

    Malone, Roy W.; Livingston, John M.

    2010-01-01

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

  8. 49 CFR Appendix C to Part 236 - Safety Assurance Criteria and Processes

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Safety Assurance Concepts as described in IEEE-1483 standard to ensure that failures are detected and the... of the standards listed below should be used unless otherwise provided. (i) IEEE standards as follows: (A) IEEE 1483-2000, Standard for the Verification of Vital Functions in Processor-Based Systems...

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

    ERIC Educational Resources Information Center

    Kimura, Aya Hirata

    2012-01-01

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

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

    SciTech Connect

    Tanke, J.M.

    1997-05-22

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

  11. Exclusion criteria for assuring safety of single-incision laparoscopic cholecystectomy.

    PubMed

    Kawaguchi, Yoshikuni; Ishizawa, Takeaki; Nagata, Rihito; Kaneko, Junichi; Sakamoto, Yoshihiro; Aoki, Taku; Sugawara, Yasuhiko; Hasegawa, Kiyoshi; Kokudo, Norihiro

    2015-12-01

    Despite increasing popularity of single-incision laparoscopic cholecystectomy (SILC), indication criteria assuring safety of SILC has yet to be established. In the present study, the subjects consisted of 146 consecutive patients undergoing conventional laparoscopic cholecystectomy (CLC) or SILC. SILC was indicated after excluding patients who met following criteria: age > 75 years, obesity, operative scar, cardiopulmonary diseases, acute cholecystitis, choledocholithiasis and abnormal bile duct anatomy. Thirty-four patients were excluded from the SILC candidates (moderate/high-risk CLC group). Among the 112 potential candidates, SILC was indicated for 23 patients (21%, SILC group) and the remaining 89 patients (79%) underwent CLC (low-risk CLC group). In the SILC group, operation time was longer than in the low-risk CLC group (171 [113-286] vs. 126 [72-240] min, p < 0.01), but the periods requiring painkiller was shorter. That led to reduced length of hospital stay compared to low-risk CLC group (2 [2-4] vs. 4 [2-12] days, p < 0.01). Between the low-risk CLC and moderate/high-risk CLC group, operation time was significantly longer and amount of blood loss was larger in the latter group. No complications were encountered in the SILC group. SILC can be indicated safely as far as appropriate criteria is adopted for excluding patients in whom complicated laparoscopic procedures are needed.

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

    NASA Technical Reports Server (NTRS)

    Leitner, Jesse A.

    2014-01-01

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

  13. Patient blood management equals patient safety.

    PubMed

    Zacharowski, Kai; Spahn, Donat R

    2016-06-01

    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.

  14. Safety of blood and blood products in Scandinavia today.

    PubMed

    Lindholm, A

    1988-01-01

    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.

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

    PubMed

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

    2015-02-01

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

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

    NASA Technical Reports Server (NTRS)

    1994-01-01

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

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

    NASA Technical Reports Server (NTRS)

    Johnson, Teresa A.

    2006-01-01

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

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

    NASA Technical Reports Server (NTRS)

    Darpel, Scott; Beckman, Sean

    2016-01-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2015-12-01

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

  20. Safety assurance of assistive devices based on a two-level checking scheme.

    PubMed

    Lin, Hua-Sheng; Chang, Yi-Chu; Chen, Chiun-Fan; Luh, Jer-Junn; Chiou, Ying-Han; Lai, Jin-Shin; Kuog, T-S

    2005-01-01

    The increasing number of physically challenged individuals has boosted the demand of powered wheelchairs. This paper is on the subject of a DSP (Digital Signal Processors) based assistive system, which is associated with a two-level checking scheme. The assistive system takes on the M3S (Multiple Master Multiple Slave) regulation for the assurance of safety. The CAN (Control Area Networks) embedded module in the DSP provides robust transmission of information within the system. The hardware interfaces based on the two-level checking scheme is implemented in input devices (e.g. joystick, head control apparatus) and in output devices (e.g. manipulator, prime mover motors).

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

    NASA Technical Reports Server (NTRS)

    Kirkpatrick, Paul D.

    2014-01-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2015-03-01

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

  3. Assurance Cases

    DTIC Science & Technology

    2015-01-26

    2015 Carnegie Mellon University Maturity of Assurance Case Technology Developed in late 90s in Europe Used for safety cases in Europe for over 20 years...The UK Ministry of Defence requires generation of a compelling case to support claims that specific safety requirements are met: “The safety case...assurance case consistent with 15026-2. Developed to help organize and structure safety cases in a readily reviewable form Used successfully for over a

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

    NASA Technical Reports Server (NTRS)

    Guarro, Sergio B.

    2010-01-01

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

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

    PubMed

    Ishikura, Satoshi

    2008-11-01

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

  6. [Immunological blood transfusion safety and selection of red blood cells issued from hospital blood banks].

    PubMed

    Py, J-Y

    2010-12-01

    Allogeneic red blood cells transfusion is always an immunological challenge and the choice of the blood products is crucial for the patient safety. But this choice may be hampered by the quality or the quantity of the available supply. In the end, the lack of transfusion may be more harmful than transfusion. The balance between patients' needs and blood centres supplying is always delicate. The conditions are not the same for all blood groups. Things are easier for the KEL1 phenotype, where the supply must ensure only 92.5% of KEL: -1 red blood cells instead of the 91% expected. More complicated is the situation for group O red blood cells with 47 versus 43%. But the major problem concerns RH: -1 red blood cells, for which the needs reach 20.1 versus 15%. These challenges require a lot of efforts from blood centres staffs to influence blood donors' recruitment and appointments. A justified and carefully selected blood products issuing may be of great help, especially for group O RH: -1 red blood cells. Therefore, hospital blood banks must have ad hoc procedures and a trained staff to put them into practice.

  7. Operational effectiveness and quality assurance mechanisms with stochastic demand of blood supply: blood bank case study.

    PubMed

    Smith, Alan D

    2011-01-01

    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.

  8. Quality assurance in blood culture: A retrospective study of blood culture contamination rate in a tertiary hospital in Nigeria

    PubMed Central

    Chukwuemeka, Iregbu Kenneth; Samuel, Yakubu

    2014-01-01

    Background: Blood culture is a critical tool for diagnosing septicaemia. Quite frequently, contamination of blood sample poses a great challenge to accurate diagnosis. This study evaluated the rate of blood culture contamination in our hospital over a one-year period. Materials and Methods: It was a retrospective study of 1032 blood cultures carried out in a clinical laboratory of a tertiary hospital in North Central part of Nigeria between 2010 and 2011. Results: There were 730 blood cultures from paediatric and 302 adult patients. The overall yield was 22%; 107 out of the 730 were contaminated giving a contamination rate of 10.4%. Contamination rate was higher in children than in adult (11% vs 8%) specimen. These rates were much higher than the acceptable benchmark of 2-3%. The main contaminants were coagulase negative Staphylococcus, Bacillus species, Diphtheroids and Enterococcus species. Conclusion: Contamination rate is high, and mainly due to normal skin flora, suggesting aseptic collection challenges as the main cause. We recommend a review of the entire process of blood collection for culture and analysis with a view to instituting appropriate quality assurance measures to reduce the contamination rate. PMID:25013249

  9. The new science of fiber safety: Assuring the safety of fiber-based materials for acoustic and noise control applications

    NASA Astrophysics Data System (ADS)

    Hadley, John

    2005-09-01

    In 2001, the International Agency for Research on Cancer (IARC) assembled a group of 18 international experts on the health effects of fibers. Their task was to review the available science on the health aspects of glass, rock, and slag wool fibers. The group of experts determined that glass, rock, and slag wool insulation fibers should be removed from the IARC list of possible carcinogens. That decision was based fundamentally on the development of new science that has led to an understanding of those properties of fibers which affect their potential biological activity. This presentation will provide both an overview of this new science and provide guidelines to assure the safety of fiber-based materials used in acoustic and noise-control applications.

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

    SciTech Connect

    Johnson, Jay Dean; Oberkampf, William Louis; Helton, Jon Craig

    2004-12-01

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

  11. Progress on resolution of major surety issues. [Safety, environmental protection, safeguards, reliability, quality assurance

    SciTech Connect

    Bell, C.R.; Boudreau, J.M.

    1985-01-01

    This paper presents a summary of the major surety issues (safety, environmental protection, sageguards, reliability, quality assurance) that have been identified during Phase I of the SP-100 Program and the progress that has been made in analyzing the most important of these issues in the context of the conceptual design effort. These issues have been identified as inadvertent criticality, toxic material release and dispersion, radiation exposure following end-of-life reentry, potential diversion of special nuclear material, failure to achieve end-of-life neutronic shutdown, and structural predictability for end-of-life re-entry or boost. Because of the complexity of these issues, a simplified conservative approach was taken during Phase I. Progress on these issues has been mainly in the area of increased understanding of the issues, identification of design features to resolve the issues, and quantitative evaluations of the surety characteristics of the various design concepts.

  12. Safety, Reliability, and Quality Assurance Provisions for the Office of Aeronautics, Exploration and Technology Centers

    NASA Technical Reports Server (NTRS)

    1991-01-01

    This Handbook establishes general safety, reliability, and quality assurance (SR&QA) guidelines for use on flight and ground-based projects conducted at the Ames, Langley, and Lewis Research Centers, hereafter identified as the Office of Aeronautics, Exploration and Technology (OAET) Centers. This document is applicable to all projects and operations conducted at these Centers except for those projects covered by more restrictive provisions such as the Space Shuttle, Space Station, and unmanned spacecraft programs. This Handbook is divided into two parts. The first (Chapters 1 and 2) establishes the SR&QA guidelines applicable to the OAET Centers, and the second (Appendices A, B, C, and D) provides examples and definitions for the total SR&QA program. Each center should implement SR&QA programs using these guidelines with tailoring appropriate to the special projects conducted by each Center. This Handbook is issued in loose-leaf form and will be revised by page changes.

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

    PubMed

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

    2010-10-01

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

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

    NASA Technical Reports Server (NTRS)

    Withrow, Colleen A.; Reveley, Mary S.

    2015-01-01

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

  15. Validity of the rule-of-fractions for assuring criticality safety margins

    SciTech Connect

    Finch, D.R.; Williamson, T.G.

    1991-10-01

    A computational study was performed to determine the validity of the Rule-Of-Fractions for assuring criticality safety margins. The form of the Rule-of-Fractions examined was the equation: {summation}{sub i} A{sub i}/ a{sub i} {le} 1 where a{sub i} is the quantity of fissile/fissionable nuclide present, and A{sub i} is the quantity of the same nuclide i that corresponds to a known margin in K{sub eff}. The study considered binary mixtures of two nuclides that exactly satisfied the equality condition of the equation. K{sub eff} values of homogeneous and heterogeneous binary mixtures of fissile/fissionable nuclides in metal and solution form were considered in spherical geometry. Results were compared to Rule-Of-Fraction predicted K{sub eff} values using an assumed linear relationship. Calculations were performed with the ANISN code with Hansen-Roach and ENDF/B-IV cross sections. The results of this study demonstrated that the Rule-Of-Fractions in the above equation does not always maintain criticality safety margins in K{sub eff} for mixtures of nuclides.

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

    NASA Technical Reports Server (NTRS)

    Anderson, Joel M.

    2011-01-01

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

  17. Numerical field calculations considering the human subject for engineering and safety assurance in MRI

    PubMed Central

    Collins, Christopher M.

    2010-01-01

    Numerical calculations of static, switched, and radiofrequency (RF) electromagnetic (EM) fields considering the geometry and EM properties of the human body are used increasingly in MRI to explain observed phenomena, explore the limitations of various approaches, engineer improved techniques and technology, and assure safety. As the static field strengths and RF field frequencies in MRI have increased in recent years, the value of these methods has become more pronounced and their use has become more widespread. With the recent growth in parallel reception techniques and the advent of transmit RF arrays, the utility of these calculations will become only more critical to continued progress of MRI. Proper relation of field calculation results to the MRI experiment can require significant understanding of MRI physics, EM field principles, MRI coil hardware, and EM field safety. Here some fundamental principles are reviewed and current approaches and applications are catalogued to aid the reader in finding resources valuable in beginning field calculations for their own applications in MR, with an eye to the current needs and future utility of numerical field calculations in MRI. PMID:18384179

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

    SciTech Connect

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

    1989-02-01

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

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

    PubMed

    Emmanuel, Jean C

    2010-01-01

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

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

    PubMed Central

    Aneke, John C.; Okocha, Chide E.

    2017-01-01

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

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

    SciTech Connect

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

    2012-09-01

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

  2. Development of a Safety Monitoring and Assurance System for chilled food products.

    PubMed

    Koutsoumanis, K; Taoukis, P S; Nychas, G J E

    2005-04-15

    The principles of a novel chill chain management policy, coded Safety Monitoring and Assurance System (SMAS) for the optimisation of the distribution of chilled food products within the chill chain are developed. In this system, a new approach based on actual risk evaluation at important points of the chill chain is used in order to promote products to the next stage of distribution. This evaluation based on product's time-temperature history, variation in product's characteristics (e.g. a(w), pH, etc.), and the use of predictive models for the growth of food pathogens, allows to give priority to products in such a way that risk at consumption time is minimized. The effectiveness of SMAS was evaluated against the First In First Out (FIFO) approach, the current method for food distribution, in a case study on the risk of listeriosis of cooked ham using the Monte Carlo simulation technique. Furthermore, the two approaches were compared for their effect on the quality of the products in terms of remaining shelf life at the time of consumption. The results showed that following the SMAS approach the risk of listerisosis is significantly lower while the spoiled products at the time of consumption are significantly reduced compared to FIFO approach.

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

    PubMed

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

    2013-08-01

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

  4. 78 FR 12062 - Nominations to the Advisory Committee on Blood and Tissue Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-21

    ... blood transfusion and tissue transplantation; and (6) identification of infectious disease transmission... knowledgeable in blood banking, transfusion medicine, plasma therapies, transfusion and transplantation safety... HUMAN SERVICES Nominations to the Advisory Committee on Blood and Tissue Safety and Availability...

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

    NASA Astrophysics Data System (ADS)

    Iwaki, Y.

    2010-07-01

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

  6. 30 CFR 250.806 - Safety and pollution prevention equipment quality assurance requirements.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 2 2014-07-01 2014-07-01 false Safety and pollution prevention equipment... CONTINENTAL SHELF Oil and Gas Production Safety Systems § 250.806 Safety and pollution prevention equipment... this section, you may install only certified safety and pollution prevention equipment (SPPE) in...

  7. 30 CFR 250.806 - Safety and pollution prevention equipment quality assurance requirements.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 2 2013-07-01 2013-07-01 false Safety and pollution prevention equipment... CONTINENTAL SHELF Oil and Gas Production Safety Systems § 250.806 Safety and pollution prevention equipment... this section, you may install only certified safety and pollution prevention equipment (SPPE) in...

  8. 30 CFR 250.806 - Safety and pollution prevention equipment quality assurance requirements.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 2 2012-07-01 2012-07-01 false Safety and pollution prevention equipment... CONTINENTAL SHELF Oil and Gas Production Safety Systems § 250.806 Safety and pollution prevention equipment... this section, you may install only certified safety and pollution prevention equipment (SPPE) in...

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

    PubMed

    Slapak, Colleen; Fredrich, Nanci; Wagner, Jeffrey

    2011-12-01

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

  10. Application of Gap Analysis to Education: A Case Study of the Food Safety and Quality Assurance Program at the University of Guelph

    ERIC Educational Resources Information Center

    Fuchs, C.; Wilcock, A.; Aung, M.

    2004-01-01

    This study was designed to identify the skills and knowledge deemed important for food safety professionals and the degree to which the Food Safety and Quality Assurance (FSQA) program at the Univ. of Guelph helps students to develop these skills. The research included 2 phases: interviews were conducted to identify these skill and knowledge…

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

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  12. West Nile Virus in Europe and Safety of Blood Transfusion

    PubMed Central

    Pisani, Giulio; Cristiano, Karen; Pupella, Simonetta; Liumbruno, Giancarlo Maria

    2016-01-01

    Summary West Nile virus (WNV) has become an increasing issue in the transfusion setting since 2002, when it was firstly shown in the USA that it can be transmitted through blood transfusion. Since then, several precautionary measures have been introduced in Europe in order to reduce the possible risk of transmission via transfusion/solid organ transplantation. In addition, the epidemiological surveillance has been tightened and the network for communication of human WNV cases strengthened. This review will focus on WNV circulation and the safety of blood in Europe. PMID:27403087

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

    PubMed

    Bruny, Jennifer; Ziegler, Moritz

    2015-12-01

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

  14. Adequacy and pattern of blood donations in north-eastern Nigeria: the implications for blood safety.

    PubMed

    Ahmed, S G; Ibrahim, U A; Hassan, A W

    2007-12-01

    In a retrospective analysis, the quantities, patterns and adequacy of blood donations made, between 1984 and 2006, at the University of Maiduguri Teaching Hospital in north-eastern Nigeria were explored and related to blood safety in the study area. The types of blood donor were reviewed and the annual increments in the number of donations made were estimated and compared with the annual increments in the numbers of in-patients managed at the study hospital. The mean annual increment in the number of blood donations (4%) fell well below the mean annual increment in in-patient numbers (11%). The blood donations received at the hospital fell into four types: voluntary, family-replacement, commercial and pre-deposit autologous donations. Over the study period, the percentage of donations falling into the voluntary and family-replacement categories fell from 31% to 5% and from 49% to 23%, respectively. These falls were matched by increases in the percentages of donations categorised as commercial and autologous, which rose from 20% to 63%, and from 1% to 9%, respectively. By the end of the study period, the quantity of blood being donated at the hospital was grossly inadequate and predominantly derived from family and commercial donors, who were found to be generally inferior, in terms of blood safety, to voluntary donors. There is an urgent need to rectify this situation by setting up a functional and national blood-transfusion service in Nigeria.

  15. Assuring food safety: the complementary tasks and standards of the World Organisation for Animal Health and the Codex Alimentarius Commission.

    PubMed

    Slorach, S A

    2006-08-01

    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.

  16. 75 FR 61143 - Meeting of the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-04

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

  17. 75 FR 28619 - Meeting of the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-21

    ... HUMAN SERVICES Meeting of the Advisory Committee on Blood Safety and Availability AGENCY: Department of... Advisory Committee on Blood Safety and Availability (ACBSA) will hold a meeting. The meeting will be open... Secretary, Advisory Committee on Blood Safety and Availability, Office of Public Health and...

  18. 76 FR 26300 - Meeting of the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-06

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

  19. 49 CFR Appendix C to Part 236 - Safety Assurance Criteria and Processes

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... INSTALLATION, INSPECTION, MAINTENANCE, AND REPAIR OF SIGNAL AND TRAIN CONTROL SYSTEMS, DEVICES, AND APPLIANCES... results of system safety analyses provided in the RSPP, PSP, PTCIP, PTCDP, and PTCSP documents as... associated with the design principle not followed. (1) System safety under normal operating conditions....

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

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... INSTALLATION, INSPECTION, MAINTENANCE, AND REPAIR OF SIGNAL AND TRAIN CONTROL SYSTEMS, DEVICES, AND APPLIANCES... results of system safety analyses provided in the RSPP, PSP, PTCIP, PTCDP, and PTCSP documents as... associated with the design principle not followed. (1) System safety under normal operating conditions....

  1. Software assurance standard

    NASA Technical Reports Server (NTRS)

    1992-01-01

    This standard specifies the software assurance program for the provider of software. It also delineates the assurance activities for the provider and the assurance data that are to be furnished by the provider to the acquirer. In any software development effort, the provider is the entity or individual that actually designs, develops, and implements the software product, while the acquirer is the entity or individual who specifies the requirements and accepts the resulting products. This standard specifies at a high level an overall software assurance program for software developed for and by NASA. Assurance includes the disciplines of quality assurance, quality engineering, verification and validation, nonconformance reporting and corrective action, safety assurance, and security assurance. The application of these disciplines during a software development life cycle is called software assurance. Subsequent lower-level standards will specify the specific processes within these disciplines.

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

    SciTech Connect

    Benedict, S.

    2015-06-15

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

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

    PubMed

    Inomata, Shinji

    2014-01-01

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

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

    PubMed

    Devine, Dana V; Schubert, Peter

    2016-06-01

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

  5. Software Assurance Using Structured Assurance Case Models

    PubMed Central

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

    2010-01-01

    Software assurance is an important part of the software development process to reduce risks and ensure that the software is dependable and trustworthy. Software defects and weaknesses can often lead to software errors and failures and to exploitation by malicious users. Testing, certification and accreditation have been traditionally used in the software assurance process to attempt to improve software trustworthiness. In this paper, we examine a methodology known as a structured assurance 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. PMID:27134787

  6. 49 CFR Appendix C to Part 236 - Safety Assurance Criteria and Processes

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... INSTALLATION, INSPECTION, MAINTENANCE, AND REPAIR OF SIGNAL AND TRAIN CONTROL SYSTEMS, DEVICES, AND APPLIANCES... application to processor-based signal and train control systems are recognized as acceptable with respect to...: 2003, Railway Applications: Communications, Signaling, and Processing Systems-Safety Related...

  7. 49 CFR Appendix C to Part 236 - Safety Assurance Criteria and Processes

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... INSTALLATION, INSPECTION, MAINTENANCE, AND REPAIR OF SIGNAL AND TRAIN CONTROL SYSTEMS, DEVICES, AND APPLIANCES... application to processor-based signal and train control systems are recognized as acceptable with respect to...: 2003, Railway Applications: Communications, Signaling, and Processing Systems-Safety Related...

  8. The procurement, storage, and quality assurance of frozen blood and tissue biospecimens in pathology, biorepository, and biobank settings

    PubMed Central

    Shabihkhani, Maryam; Lucey, Gregory M.; Wei, Bowen; Mareninov, Sergey; Lou, Jerry J.; Vinters, Harry V.; Singer, Elyse J.; Cloughesy, Timothy F.; Yong, William H.

    2014-01-01

    Well preserved frozen biospecimens are ideal for evaluating the genome, transcriptome, and proteome. While papers reviewing individual aspects of frozen biospecimens are available, we present a current overview of experimental data regarding procurement, storage, and quality assurance that can inform the handling of frozen biospecimens. Frozen biospecimen degradation can be influenced by factors independent of the collection methodology including tissue type, premortem agonal changes, and warm ischemia time during surgery. Rapid stabilization of tissues by snap freezing immediately can mitigate artifactually altered gene expression and, less appreciated, protein phosphorylation profiles. Collection protocols may be adjusted for specific tissue types as cellular ischemia tolerance varies widely. If data is not available for a particular tissue type, a practical goal is snap freezing within 20 minutes. Tolerance for freeze-thaw events is also tissue type dependent. Tissue storage at −80°C can preserve DNA and protein for years but RNA can show degradation at 5 years. For −80°C freezers, aliquots frozen in RNAlater or similar RNA stabilizing solutions is a consideration. It remains unresolved as to whether storage at −150°C provides significant advantages relative to −80°C. 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. Biobanking protocols for blood and its components are highly dependent on intended use and multiple collection tube types may be needed. Additional quality assurance testing should be dictated by the anticipated downstream applications. PMID:24424103

  9. 76 FR 68192 - Meeting of the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-03

    ... Blood Safety and Availability AGENCY: Department of Health and Human Services, Office of the Secretary... Advisory Committee on Blood Safety and Availability (ACBSA) will hold a meeting. The meeting will be open... Assistant Secretary for Health, on a broad range of issues involving the safety and availability of...

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

    PubMed

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

    2008-11-01

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

  11. 75 FR 71444 - Renewal of Charter for the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-23

    ... HUMAN SERVICES Renewal of Charter for the Advisory Committee on Blood Safety and Availability AGENCY... the Advisory Committee on Blood Safety and Availability (ACBSA). FOR FURTHER INFORMATION CONTACT: Jerry Holmberg, PhD; Senior Advisor for Blood Policy and Executive Secretary, Advisory Committee...

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

    PubMed

    Cockburn, Andrew

    2002-09-11

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

  13. Exposing Exposure: Enhancing Patient Safety through Automated Data Mining of Nuclear Medicine Reports for Quality Assurance and Organ Dose Monitoring

    PubMed Central

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

    2012-01-01

    Purpose: To develop and validate an open-source informatics toolkit capable of creating a radiation exposure data repository from existing nuclear medicine report archives and to demonstrate potential applications of such data for quality assurance and longitudinal patient-specific radiation dose monitoring. Materials and Methods: This study was institutional review board approved and HIPAA compliant. Informed consent was waived. An open-source toolkit designed to automate the extraction of data on radiopharmaceuticals and administered activities from nuclear medicine reports was developed. After iterative code training, manual validation was performed on 2359 nuclear medicine reports randomly selected from September 17, 1985, to February 28, 2011. Recall (sensitivity) and precision (positive predictive value) were calculated with 95% binomial confidence intervals. From the resultant institutional data repository, examples of usage in quality assurance efforts and patient-specific longitudinal radiation dose monitoring obtained by calculating organ doses from the administered activity and radiopharmaceutical of each examination were provided. Results: Validation statistics yielded a combined recall of 97.6% ± 0.7 (95% confidence interval) and precision of 98.7% ± 0.5. Histograms of administered activity for fluorine 18 fluorodeoxyglucose and iodine 131 sodium iodide were generated. An organ dose heatmap which displays a sample patient’s dose accumulation from multiple nuclear medicine examinations was created. Conclusion: Large-scale repositories of radiation exposure data can be extracted from institutional nuclear medicine report archives with high recall and precision. Such repositories enable new approaches in radiation exposure patient safety initiatives and patient-specific radiation dose monitoring. © RSNA, 2012 PMID:22627599

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

    PubMed

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

    2007-04-11

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

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

    PubMed

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

    2017-01-01

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

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

    PubMed

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

    2013-01-01

    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.

    PubMed

    Berends, B R; van Knapen, F

    1999-10-01

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

  18. [Universal implementation of pathogen inactivation in labile blood products is a major step towards transfusion safety].

    PubMed

    Cazenave, Jean-Pierre

    2010-12-01

    Transfusion of labile blood products (red cell concentrates, platelet concentrates and plasma) is vital in the absence of alternatives. Patients and doctors have always feared infections transmitted by blood, blood components and blood-derived drugs. It is potentially dangerous to delay implementation of pathogen inactivation in labile blood products pending a perfect process. Universal implementation of pathogen inactivation in labile blood products is a major step towards transfusion safety.

  19. 76 FR 76732 - Nominations to the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-08

    ... transplantation safety. The representative members are selected from the following groups: The AABB, the plasma... organization or manufacturer of blood, plasma, or other tissue test kits or equipment, and a purchaser of blood..., one of the two major distributors of blood, a trade organization, or manufacturer of blood,...

  20. 76 FR 15982 - Nominations to the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-22

    ... Blood Banks); the plasma protein fraction community; one of the two major distributors of blood on a rotating basis, a trade organization or manufacturer of blood, plasma, infectious disease screening assays... blood banking, transfusion medicine, plasma therapies, transfusion and transplantation safety,...

  1. Results of a 13 week safety assurance study with rats fed grain from glyphosate tolerant corn.

    PubMed

    Hammond, B; Dudek, R; Lemen, J; Nemeth, M

    2004-06-01

    The current study presents the results of a 13 week feeding study in rats with grain from Roundup Ready corn which is tolerant to the herbicide glyphosate. Herbicide tolerance was accomplished through the introduction of cp4 epsps coding sequences into the corn genome for in planta production of CP4 EPSPS enzymes. Unlike related corn EPSPS enzymes, CP4 EPSPS enzymes are not inhibited by the herbicide glyphosate. Purina TestDiets formulated Roundup Ready corn grain into rodent diets at levels of 11 and 33% (w/w). The responses of rats fed diets containing Roundup Ready corn grain were compared to that of rats fed diets containing non-transgenic grain (controls). All diets were nutritionally balanced and conformed to Purina Mills, Inc. specifications for Certified LabDiet 5002. There were 400 rats in the study divided into 10 groups of 20 rats/sex/group. Overall health, body weight, food consumption, clinical pathology parameters (hematology, blood chemistry, urinalysis), organ weights, gross and microscopic appearance of tissues were comparable between groups fed diets containing Roundup Ready and control corn grain. This study complements extensive agronomic, compositional and farm animal feeding studies with Roundup Ready corn grain, confirming it is as safe and nutritious as existing commercial corn hybrids.

  2. Reliability analysis in the Office of Safety, Environmental, and Mission Assurance (OSEMA)

    NASA Technical Reports Server (NTRS)

    Kauffmann, Paul J.

    1994-01-01

    The technical personnel in the SEMA office are working to provide the highest degree of value-added activities to their support of the NASA Langley Research Center mission. Management perceives that reliability analysis tools and an understanding of a comprehensive systems approach to reliability will be a foundation of this change process. Since the office is involved in a broad range of activities supporting space mission projects and operating activities (such as wind tunnels and facilities), it was not clear what reliability tools the office should be familiar with and how these tools could serve as a flexible knowledge base for organizational growth. Interviews and discussions with the office personnel (both technicians and engineers) revealed that job responsibilities ranged from incoming inspection to component or system analysis to safety and risk. It was apparent that a broad base in applied probability and reliability along with tools for practical application was required by the office. A series of ten class sessions with a duration of two hours each was organized and scheduled. Hand-out materials were developed and practical examples based on the type of work performed by the office personnel were included. Topics covered were: Reliability Systems - a broad system oriented approach to reliability; Probability Distributions - discrete and continuous distributions; Sampling and Confidence Intervals - random sampling and sampling plans; Data Analysis and Estimation - Model selection and parameter estimates; and Reliability Tools - block diagrams, fault trees, event trees, FMEA. In the future, this information will be used to review and assess existing equipment and processes from a reliability system perspective. An analysis of incoming materials sampling plans was also completed. This study looked at the issues associated with Mil Std 105 and changes for a zero defect acceptance sampling plan.

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

    NASA Astrophysics Data System (ADS)

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

    2009-11-01

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

  4. Reliability analysis in the Office of Safety, Environmental, and Mission Assurance (OSEMA)

    NASA Astrophysics Data System (ADS)

    Kauffmann, Paul J.

    1994-12-01

    The technical personnel in the SEMA office are working to provide the highest degree of value-added activities to their support of the NASA Langley Research Center mission. Management perceives that reliability analysis tools and an understanding of a comprehensive systems approach to reliability will be a foundation of this change process. Since the office is involved in a broad range of activities supporting space mission projects and operating activities (such as wind tunnels and facilities), it was not clear what reliability tools the office should be familiar with and how these tools could serve as a flexible knowledge base for organizational growth. Interviews and discussions with the office personnel (both technicians and engineers) revealed that job responsibilities ranged from incoming inspection to component or system analysis to safety and risk. It was apparent that a broad base in applied probability and reliability along with tools for practical application was required by the office. A series of ten class sessions with a duration of two hours each was organized and scheduled. Hand-out materials were developed and practical examples based on the type of work performed by the office personnel were included. Topics covered were: Reliability Systems - a broad system oriented approach to reliability; Probability Distributions - discrete and continuous distributions; Sampling and Confidence Intervals - random sampling and sampling plans; Data Analysis and Estimation - Model selection and parameter estimates; and Reliability Tools - block diagrams, fault trees, event trees, FMEA. In the future, this information will be used to review and assess existing equipment and processes from a reliability system perspective. An analysis of incoming materials sampling plans was also completed. This study looked at the issues associated with Mil Std 105 and changes for a zero defect acceptance sampling plan.

  5. Viral safety of solvent/detergent-treated blood products.

    PubMed

    Horowitz, B; Prince, A M; Hamman, J; Watklevicz, C

    1994-12-01

    Laboratory research that began in 1982 led to the licensing in the USA of a solvent/detergent (SD)-treated factor VIII concentrate in 1985. The licence was granted on the basis of several factors. First, studies had demonstrated the inactivation of several marker viruses (vesicular stomatitis virus, Sindbis virus, Sendai virus) and other viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and non-A, non-B hepatitis virus (NANBHV; now known principally to be hepatitis C virus) added to the factor VIII concentrate just before treatment. Secondly, it had been realized that the relevant viruses in transfusion (e.g. HIV, HBV, NANBHV) all had lipid envelopes. Finally, laboratory, preclinical and clinical evidence indicated that factor VIII and other proteins present in the preparation were unaffected by SD treatment. The applicability of the SD method to a wide range of products and preparations, high process recoveries and a growing body of viral safety information linked with the failure of several other virus-inactivation methods to eliminate hepatitis transmission fostered the adoption of SD technology by more than 50 organizations worldwide. SD mixtures are now used in the preparation of a diverse array of products. Numerous laboratory and clinical studies suggest that coagulation-factor concentrates and other SD-treated products prepared from plasma pools are now safer than the individual units from which they were derived. Also, a large body of evidence indicates that hepatitis A virus (HAV) is not typically transmitted by blood and blood products.(ABSTRACT TRUNCATED AT 250 WORDS)

  6. Substantial improvements in performance indicators achieved in a peripheral blood mononuclear cell cryopreservation quality assurance program using single donor samples.

    PubMed

    Dyer, Wayne B; Pett, Sarah L; Sullivan, John S; Emery, Sean; Cooper, David A; Kelleher, Anthony D; Lloyd, Andrew; Lewin, Sharon R

    2007-01-01

    Storage of high-quality cryopreserved peripheral blood mononuclear cells (PBMC) is often a requirement for multicenter clinical trials and requires a reproducibly high standard of practice. A quality assurance program (QAP) was established to assess an Australia-wide network of laboratories in the provision of high-quality PBMC (determined by yield, viability, and function), using blood taken from single donors (human immunodeficiency virus [HIV] positive and HIV negative) and shipped to each site for preparation and cryopreservation of PBMC. The aim of the QAP was to provide laboratory accreditation for participation in clinical trials and cohort studies which require preparation and cryopreservation of PBMC and to assist all laboratories to prepare PBMC with a viability of >80% and yield of >50% following thawing. Many laboratories failed to reach this standard on the initial QAP round. Interventions to improve performance included telephone interviews with the staff at each laboratory, two annual wet workshops, and direct access to a senior scientist to discuss performance following each QAP round. Performance improved substantially in the majority of sites that initially failed the QAP (P = 0.002 and P = 0.001 for viability and yield, respectively). In a minority of laboratories, there was no improvement (n = 2), while a high standard was retained at the laboratories that commenced with adequate performance (n = 3). These findings demonstrate that simple interventions and monitoring of PBMC preparation and cryopreservation from multiple laboratories can significantly improve performance and contribute to maintenance of a network of laboratories accredited for quality PBMC fractionation and cryopreservation.

  7. The interlaboratorial quality assurance program for blood lead determination. An evaluation of methods and results.

    PubMed

    Morisi, G; Patriarca, M; Taggi, F

    1989-01-01

    For over five years a national program, promoted by a working group of the Istituto Superiore di Sanità (Italian National Institute of Health), has been active in Italy for the quality control of the blood lead levels determination. The program is based on the adoption, by the laboratories, of the same known-titre materials, for the internal quality control, and on the participation in periodical collaborative exercises for the external quality evaluation. The promoting laboratory prepared the control samples, verified their homogeneity and stability and distributed them to the laboratories following a randomized procedure; then, it provided a preliminary elaboration of the results (precision, difference from the median, distribution) after each exercise, and carried out the global evaluation of the performances of each laboratory after at least one year of activity in the program using parametric (regression analysis) and non-parametric (evaluation of the results according to pre-determined acceptability criteria) statistical methods. After four years of activity, the results obtained show that the adopted scheme and the procedures used turned out to be adequate. The study of the regression parameters between the results of each laboratory and the medians of the results of all the laboratories has confirmed the validity of the graphic criterion adopted, also yielding specific information on the relative contribution of the different kinds of error (systematic, constant and/or proportional and casual) to the global error. Furthermore, the proportion of the laboratories with "good level" performances (i.e., acceptable results in at least 80% of the examined samples) has increased from approximately 30% in the first phase to approximately 50% in the fourth phase.

  8. [The management of post donation information: a fundamental element of blood safety].

    PubMed

    Hervé, I; Simonet, M; Rebibo, D; Leconte des Floris, M-F; Taouqi-Le Cann, M; Jbilou, S; Brunet, A

    2010-12-01

    Post donation information management is a fundamental axis of haemovigilance in terms of blood safety. It requires an organization ensuring a permanent reactivity, a good sensitization of French National Blood Service professionals and needs also a strong awareness of blood donors. Previous identification of stakeholders to warn during these kinds of alerts is essential to avoid the use of any blood product presenting a potential risk. The recent implementation of a consensual internal document aims to target the reinforcement of a homogeneous decision-making process, combining blood product self-sufficiency and above all recipient safety.

  9. NASA assurance terms and definitions

    NASA Technical Reports Server (NTRS)

    1993-01-01

    This publication provides a compendium of commonly used safety, reliability, maintainability, and quality assurance (SRM&QA) definitions to ensure standardized assurance communications among NASA Field Installations, Headquarters, and contractors. This list of standard assurance terms and definitions shall be utilized by all NASA organizations and contractors. Program/project tailoring of these definitions may be permitted for specific program applications.

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

    PubMed Central

    Agarwal, Rajat Kumar; Dhanya, Rakesh; Parmar, Lalith G.; Vaish, Arpit; Sedai, Amit; Periyavan, Sundar

    2015-01-01

    Aims: The compliance of safety and quality parameters laid out by national and international guidelines in outdoor blood donation camps has not been studied in India. Our study aimed at identifying, monitoring, analyzing, and developing preventive strategies for several key parameters associated with the quality and safety of outdoor voluntary blood donation camps (VBDC). Settings: The study covered a total of 424 VBDCs at various locations in Bengaluru, Karnataka (South India) from 2009 to 2013. Seven government hospitals based blood banks, three private hospitals based blood banks and two voluntary standalone blood banks participated in the VBDCs included in the study. Materials and Methods: At the onset, the quality and safety standards to be followed were discussed and agreed upon. During the study, noncompliance (NC) to the agreed upon standards were recorded and shared. Periodic trainings were also organized to help minimize NC. Results: One or more instances of NC in 73% of the VBDCs. Highest NC were observed associated with punctuality (34%), wearing gloves (16%), hemoglobin (Hb) estimation (11%) and donor screening and selection other than Hb check (8-9%). Conclusion: For all 16 parameters under study, significant NC was observed. As a whole private hospital based blood banks were more noncompliant. The high degree of NC to matters relating to quality and safety in VBDCs is high and warrants for urgent attention and further study. Our study also shows that regular monitoring and systematic and strategic intervention can decrease the rate of NC. PMID:25722568

  11. [Quality and quality assurance, a European problem].

    PubMed

    Schmitt, H

    1994-01-01

    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.

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

    NASA Technical Reports Server (NTRS)

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

    2009-01-01

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

  13. Separation Assurance and Collision Avoidance

    NASA Technical Reports Server (NTRS)

    Lauderdale, Todd

    2010-01-01

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

  14. Blood transfusion safety in Africa: a literature review of infectious disease and organizational challenges.

    PubMed

    Bloch, Evan M; Vermeulen, Marion; Murphy, Edward

    2012-04-01

    Blood safety remains an important public health concern in Africa where lack of availability or provision of unsafe blood adversely impacts morbidity and mortality in the region. In recognition of this shortfall, the World Health Organization (WHO) established a goal of regional blood safety by 2012 through improved "organization and management, blood donor recruitment and collection, testing of donor blood as well as appropriate clinical use of blood" (Tagny et al: Transfusion. 2008;48:1256-1261; Tapko et al: Status of Blood Safety in the WHO African Region: Report of the 2006 Survey http://www.afro.who.int/en/divisions-a-programmes/dsd/health-technologies-a-laboratories.html. Brazzaville, Republic of Congo: WHO Regional Office for Africa; 2006). Although there has been substantial progress toward meeting these objectives, there are continued obstacles to both development and sustainability. In a setting where transfusion oversight is still being improved, transfusion-transmitted infections are of real concern. The high prevalence of some transfusion-transmissible agents such as hepatitis B virus and HIV in the general population means that some infected blood units escape detection by even well-performed laboratory testing, resulting in potential downstream transmission to patients. The spectrum of transfusion-transmitted infection include conventional as well as exotic pathogens, many of which are endemic to the region, thereby imparting ongoing challenges to recruitment and testing strategies.

  15. Efficacy, Safety and Mechanisms of Blood Flow Restricted Exercise

    NASA Technical Reports Server (NTRS)

    Ploutz-Snyder, Lori

    2009-01-01

    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).

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

    PubMed

    Ilinskaya, Anna N; Dobrovolskaia, Marina A

    2013-06-01

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

  17. The Hermes safety strategy

    NASA Astrophysics Data System (ADS)

    Rosso, R.

    1992-08-01

    The principal safety objectives and safety assurance strategies of the Hermes space vehicle program are discussed. The highlights of the Hermes safety assurance strategy are reviewed with particular reference to risk identification, risk evaluation, risk reduction, and risk acceptance. The application of the safety assurance strategy to Phase I definition studies and safety objectives of the Hermes X 2000 mission are then discussed.

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

    PubMed Central

    Makroo, Raj Nath; Bhatia, Aakanksha

    2017-01-01

    BACKGROUND: Blood grouping is the single most important test performed by each and every transfusion service. A blood group error has a potential for causing severe life-threatening complications. A number of process strategies have been adopted at various institutions to prevent the occurrence of errors at the time of phlebotomy, pretransfusion testing, and blood administration. A delta check is one such quality control tool that involves the comparison of laboratory test results with results obtained on previous samples from the same patient. MATERIALS AND METHODS: We retrieved the records of all transfusion-related incidents reported in our institute, between January 2008 and December 2014. Errors identified as “Failed Delta checks” and their root cause analyses (RCA) were reviewed. RESULTS: A total of 17,034 errors related to blood transfusion were reported. Of these, 38 were blood grouping errors. Seventeen blood group errors were identified due to failed delta checks, where the results of two individually drawn grouping samples yielded different blood group results. The RCA revealed that all of these errors occurred in the preanalytical phase of testing. Mislabeling resulting in wrong blood in tube was the most commonly identified cause, accounting for 11 of these errors, while problems with correct patient identification accounted for 5 failed delta checks. CONCLUSION: Delta checks proved to be an effective tool for detecting blood group errors and prevention of accidental mismatched blood transfusions. Preanalytical errors in patient identification or sample labeling were the most frequent. PMID:28316435

  19. Blood Transfusion Safety in Africa: A Literature Review of Infectious Disease and Organizational Challenges

    PubMed Central

    Bloch, Evan M.; Vermeulen, Marion; Murphy, Edward

    2013-01-01

    Blood safety remains an important public health concern in Africa where lack of availability or provision of unsafe blood adversely impacts morbidity and mortality in the region. In recognition of this shortfall, the World Health Organization (WHO) established a goal of regional blood safety by 2012 through improved “organization and management, blood donor recruitment and collection, testing of donor blood as well as appropriate clinical use of blood” (Tagny et al: Transfusion. 2008;48:1256–1261; Tapko et al: Status of Blood Safety in the WHO African Region: Report of the 2006 Survey http://www.afro.who.int/en/divisions-a-programmes/dsd/health-technologies-a-laboratories.html. Brazzaville, Republic of Congo: WHO Regional Office for Africa; 2006). Although there has been substantial progress toward meeting these objectives, there are continued obstacles to both development and sustainability. In a setting where transfusion oversight is still being improved, transfusion-transmitted infections are of real concern. The high prevalence of some transfusion-transmissible agents such as hepatitis B virus and HIV in the general population means that some infected blood units escape detection by even well-performed laboratory testing, resulting in potential downstream transmission to patients. The spectrum of transfusion-transmitted infection include conventional as well as exotic pathogens, many of which are endemic to the region, thereby imparting ongoing challenges to recruitment and testing strategies. PMID:21872426

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

    SciTech Connect

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

    1994-10-01

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

  1. Quality assurance of metabolomics.

    PubMed

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

    2015-01-01

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

  2. Healthcare Software Assurance

    PubMed Central

    Cooper, Jason G.; Pauley, Keith A.

    2006-01-01

    Software assurance is a rigorous, lifecycle phase-independent set of activities which ensure completeness, safety, and reliability of software processes and products. This is accomplished by guaranteeing conformance to all requirements, standards, procedures, and regulations. These assurance processes are even more important when coupled with healthcare software systems, embedded software in medical instrumentation, and other healthcare-oriented life-critical systems. The current Food and Drug Administration (FDA) regulatory requirements and guidance documentation do not address certain aspects of complete software assurance activities. In addition, the FDA’s software oversight processes require enhancement to include increasingly complex healthcare systems such as Hospital Information Systems (HIS). The importance of complete software assurance is introduced, current regulatory requirements and guidance discussed, and the necessity for enhancements to the current processes shall be highlighted. PMID:17238324

  3. Application and validation of the TTI based chill chain management system SMAS (Safety Monitoring and Assurance System) on shelf life optimization of vacuum packed chilled tuna.

    PubMed

    Tsironi, Theofania; Gogou, Eleni; Velliou, Eirini; Taoukis, Petros S

    2008-11-30

    The objective of the study was to establish a validated kinetic model for growth of spoilage bacteria on vacuum packed tuna slices in the temperature range of 0 to 15 degrees C and to evaluate the applicability of the TTI (Time Temperature Integrators) based SMAS (Safety Monitoring and Assurance System) system to improve tuna product quality at the time of consumption in comparison to the conventional First In First Out (FIFO) approach. The overall measurements of total flora and lactic acid bacteria (LAB) on the tuna samples used in a laboratory simulated field test were in close agreement with the predictions of the developed kinetic model. The spoilage profile of the TTI bearing products, handled with SMAS, was improved. Three out of the thirty products that were handled randomly, according to the FIFO approach, were already spoiled at the time of consumption (logN(LAB)>6.5) compared to no spoiled products when handled with the SMAS approach.

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

    NASA Astrophysics Data System (ADS)

    Cysewska-Sobusiak, Anna

    2001-08-01

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

  5. A congressional counterpoint: challenging the Reagan Administration on the safety of blood and blood products.

    PubMed

    Robbins, Anthony

    2012-08-01

    When the US Centers for Disease Control met a hard wall of political restraint in attempting a full response to the emergency of AIDS in the early 1980s, it was possible to move toward protection of blood and blood products from the legislative branch of government instead - despite resistance from the Red Cross, blood banks, and the Reagan Administration. A Congressional creation, the Office of Technology Assessment (OTA), received a request from the author, made on behalf of his employer, the Chairman of a Congressional Committee and a Member of the OTA Congressional Board. He asked the OTA to assess US blood policy in light of scientific and technological developments - most importantly the new disease, AIDS. The OTA issued its report in January 1985. In 1995, a new Republican majority in both legislative chambers eliminated the OTA - and thus a valuable source of policy analysis of scientific issues independent of the executive branch.

  6. Large volume leukapheresis: Efficacy and safety of processing patient's total blood volume six times.

    PubMed

    Bojanic, Ines; Dubravcic, Klara; Batinic, Drago; Cepulic, Branka Golubic; Mazic, Sanja; Hren, Darko; Nemet, Damir; Labar, Boris

    2011-04-01

    Large-volume leukapheresis (LVL) differs from standard leukapheresis by increased blood flow and an altered anticoagulation regimen. An open issue is to what degree a further increase in processed blood volume is reasonable in terms of higher yields and safety. In 30 LVL performed in patients with hematologic malignancies, 6 total blood volumes were processed. LVL resulted in a higher CD34+ cell yield without a change in graft quality. Although a marked platelet decrease can be expected, LVL is safe and can be recommended as the standard procedure for patients who mobilize low numbers of CD34+ cells and when high number of CD34+ cells are required.

  7. Mission Assurance and Flight Safety of Manned Space Flight: Implications for Future Exploration of the Moon and Mars

    NASA Technical Reports Server (NTRS)

    Kezirian, M. T.

    2007-01-01

    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.

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

    PubMed

    Custer, Brian; Janssen, Mart P

    2015-08-01

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

  9. Blood transfusions in critical care: improving safety through technology & process analysis.

    PubMed

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

    2010-06-01

    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.

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

    PubMed

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

    2016-05-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    SciTech Connect

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

    1990-04-01

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

  13. Quality Assurance.

    ERIC Educational Resources Information Center

    Massachusetts Career Development Inst., Springfield.

    This booklet is one of six texts from a workplace literacy curriculum designed to assist learners in facing the increased demands of the workplace. The booklet contains five sections that cover the following topics: (1) importance of reliability; (2) meaning of quality assurance; (3) historical development of quality assurance; (4) statistical…

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

    SciTech Connect

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

    1988-02-01

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

  15. Safety Evaluation of Hemoglobin-Albumin Cluster "HemoAct" as a Red Blood Cell Substitute.

    PubMed

    Haruki, Risa; Kimura, Takuya; Iwasaki, Hitomi; Yamada, Kana; Kamiyama, Ikuo; Kohno, Mitsutomo; Taguchi, Kazuaki; Nagao, Saori; Maruyama, Toru; Otagiri, Masaki; Komatsu, Teruyuki

    2015-07-29

    A hemoglobin (Hb) wrapped covalently by human serum albumins (HSAs), a core-shell structured hemoglobin-albumin cluster designated as "HemoAct", is an O2-carrier designed for use as a red blood cell (RBC) substitute. This report describes the blood compatibility, hemodynamic response, and pharmacokinetic properties of HemoAct, and then explains its preclinical safety. Viscosity and blood cell counting measurements revealed that HemoAct has good compatibility with whole blood. Intravenous administration of HemoAct into anesthetized rats elicited no unfavorable increase in systemic blood pressure by vasoconstriction. The half-life of (125)I-labeled HemoAct in circulating blood is markedly longer than that of HSA. Serum biochemical tests conducted 7 days after HemoAct infusion yielded equivalent values to those observed in the control group with HSA. Histopathologic inspections of the vital organs revealed no marked abnormality in their tissues. All results indicate that HemoAct has sufficient preclinical safety as an alternative material for RBC transfusion.

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

    PubMed Central

    Kent, Julie; Farrell, Anne-Maree

    2014-01-01

    The clinical use of blood has a long history, but its apparent stability belies the complexity of contemporary practices in this field. In this article, we explore how the production, supply and deployment of blood products are socially mediated, drawing on theoretical perspectives from recent work on ‘tissue economies’. We highlight the ways in which safety threats in the form of infections that might be transmitted through blood and plasma impact on this tissue economy and how these have led to a revaluation of donor bodies and restructuring of blood economies. Specifically, we consider these themes in relation to the management of recent threats to blood safety in the United Kingdom. We show that the tension between securing the supply of blood and its products and ensuring its safety may give rise to ethical concerns and reshape relations between donor and recipient bodies. PMID:23467898

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

    PubMed

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

    2017-01-01

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

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

    SciTech Connect

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

    1998-10-01

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

  19. 10 CFR 76.93 - Quality assurance.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 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...

  20. 10 CFR 76.93 - Quality assurance.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 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...

  1. 10 CFR 76.93 - Quality assurance.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 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...

  2. 10 CFR 76.93 - Quality assurance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  3. 10 CFR 76.93 - Quality assurance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 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...

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

    PubMed

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

    2017-01-01

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

  5. Nova laser assurance-management system

    SciTech Connect

    Levy, A.J.

    1983-07-18

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

  6. [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].

    PubMed

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

    2013-05-01

    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

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

    PubMed

    Heinrich, Michael

    2015-07-01

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

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

    PubMed Central

    Heinrich, Michael

    2015-01-01

    Herbal medicines and products derived from them are a diverse group of products for which different (and often limited) levels of evidence are available. As importantly, such products generally vary in their composition and are at the end of an often poorly understood value chain, which often links producers in biodiversity rich countries with the large markets in the North. This paper discusses the current regulatory framework of such herbal medical products (with a focus on the UK) and using examples from our own metabolomic research on Curcumal longa L. (turmeric, Zingiberaceae) how value chains impact on the composition and quality (and thus the safety) of such products. Overall, our recent research demonstrates the need for studying the links between producers and consumers of commodities produced in provider countries and that plant metabolomics offer a novel way of assessing the chemical variability along a value chain. PMID:25581270

  9. Water storage equity and safety assurance policy to mitigate potential 'dual-extreme cumulative threats' in agricultural catchments

    NASA Astrophysics Data System (ADS)

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

    2017-02-01

    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.

  10. Systemic Assurance

    DTIC Science & Technology

    2015-07-31

    to, warranty of fitness for purpose or merchantability, exclusivity, or results obtained from use of the material. Stevens Institute of Technology...customer organizations judge them fit for use in the mission environment. These assurance judgments must be based on evidence that a system manifests...which it is achieved. Assurance is a human judgment of fitness for use. This judgment is thus contextualized by the mission definition, the features

  11. Quality assurance program plan for Building 327

    SciTech Connect

    Tanke, J.M.

    1997-05-22

    This Quality Assurance Program Plan (QAPP) provides an overview of the quality assurance program for Building 327. The program applies to the facility safety structures, systems, and components and to activities that could affect safety structures, systems, and components. Adherence to the quality assurance program ensures the following: US Department of Energy missions and objectives are effectively accomplished; Products and services are safe, reliable, and meet or exceed the requirements and expectations of the user; Hazards to the public, to Hanford Site and facility workers, and to the environment are minimized. The format of this Quality Assurance Program Plan is structured to parallel that of 10 CFR 83 0.120, Quality Assurance Requirements. This Quality Assurance Program Plan (QAPP) provides information on how the Quality Assurance Program is implemented for the 324 Building B-Cell Safety Cleanout Project (BCCP). This QAPP is responsive to the Westinghouse Hanford Company Quality Assurance Program and Implementation Plan, WHC-SP 113 1, for 10 CFR 830.120, Nuclear Safety Management, Quality Assurance Requirements; and DOE Order 5700.6C, Quality Assurance. This QAPP supersedes PNNL PNL-MA-70 QAP Quality Assurance Plan No. WTC-050 Rev. 2, issue date May 3, 1996.

  12. NASA's Approach to Software Assurance

    NASA Technical Reports Server (NTRS)

    Wetherholt, Martha

    2015-01-01

    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.

  13. Efforts in blood safety: Integrated approach for serological diagnosis of syphilis

    PubMed Central

    Sommese, Linda; De Pascale, Maria Rosaria; Capuano, Maria; Napoli, Claudio

    2016-01-01

    Recent efforts in transfusion medicine are focused on improving blood safety as well as establishing effective and efficient diagnostic algorithms for donor screening. To date, syphilis is a transfusion-transmitted infection re-emerged in many countries as a public health threat especially among populations at specific risk. This task requires new diagnostic tools and hemovigilance programs. The current diagnostic methodologies are debated, since presenting limitations and unresolved issues with special regard to the clinical interpretation of serological patterns, especially in asymptomatic patients and in blood donors. Furthermore, the switch from the traditional to alternative diagnostic algorithms underlines the lack of a gold standard, which has not been supported by shared guidelines. Besides, a lot of ongoing clinical trials on the performance of diagnostic assays, on the serological response associated with different pharmacological treatments, as well as on the prevention programs are currently under investigation. Here, we review the recent literature about the diagnosis of syphilis especially for low-risk populations proposing the adoption of an algorithm for blood donor screening that should satisfy the need of increasing safety for transfusion-transmitted infections in the modern blood transfusion centers. PMID:27011666

  14. Results of a 90-day safety assurance study with rats fed grain from corn rootworm-protected corn.

    PubMed

    Hammond, B; Lemen, J; Dudek, R; Ward, D; Jiang, C; Nemeth, M; Burns, J

    2006-02-01

    The results of a 90-day rat feeding study with YieldGard (YieldGard Rootworm Corn is a registered trademark of Monsanto Technology, LLC.) Rootworm corn (MON 863) grain that is protected against feeding damage caused by corn rootworm larvae are presented. Corn rootworm-protection was accomplished through the introduction of a cry3Bb1 coding sequence into the corn genome for in planta production of a modified Cry3Bb1 protein from Bacillus thuringiensis. Grain from MON 863 and its near isogenic control were separately formulated into rodent diets at levels of 11% and 33% (w/w) by Purina Mills, Inc. Additionally, six groups of rats were fed diets containing grain from different conventional (non-biotechnology-derived) reference varieties. The responses of rats fed diets containing MON 863 were compared to those of rats fed grain from conventional corn varieties. All diets were nutritionally balanced and conformed to Purina Mills, Inc. specifications for Certified LabDiet 5002. There were a total of 400 rats in the study divided into 10 groups of 20 rats/sex/group. Overall health, body weight gain, food consumption, clinical pathology parameters (hematology, blood chemistry, urinalysis), organ weights, gross and microscopic appearance of tissues were comparable between groups fed diets containing MON 863 and conventional corn varieties. This study complements extensive agronomic, compositional and farm animal feeding studies with MON 863 grain, confirming that it is as safe and nutritious as existing conventional corn varieties.

  15. Results of a 90-day safety assurance study with rats fed grain from corn borer-protected corn.

    PubMed

    Hammond, B G; Dudek, R; Lemen, J K; Nemeth, M A

    2006-07-01

    The results of a 90-day rat feeding study with grain from MON 810 corn (YieldGard Cornborer -- YieldGard Cornborer is a registered trademark of Monsanto Technology, LLC) that is protected against feeding damage from corn and stalk boring lepidopteran insects are presented. Corn borer protection was accomplished through the introduction of cry1Ab coding sequences into the corn genome for in planta production of a bioactive form of Cry1Ab protein. Grain from MON 810 and its near-isogenic control was separately formulated into rodent diets at levels of 11% and 33% (w/w) by Purina Mills, Inc. (PMI). All diets were nutritionally balanced and conformed to PMI specifications for Certified LabDiet (PMI Certified LabDiet 5002 is a registered trademark of Purina Mills, Inc.) 5002. There were a total of 400 rats in the study divided into 10 groups of 20 rats/sex/group. The responses of rats fed diets containing MON 810 were compared to those of rats fed grain from conventional corn varieties. Overall health, body weight, food consumption, clinical pathology parameters (hematology, blood chemistry, urinalysis), organ weights, and gross and microscopic appearance of tissues were comparable between groups fed diets containing MON 810 and conventional corn varieties. This study complements extensive agronomic, compositional and farm animal feeding studies with MON 810 grain, confirming that it is as safe and nutritious as grain from existing commercial corn varieties.

  16. [Pathogen inactivation in labile blood products: transfusion safety and economic impact].

    PubMed

    Cazenave, Jean-Pierre

    2006-01-01

    The safety of labile blood products (red blood cell concentrates, platelet concentrates and plasma) is currently ensured by medical and biological donor selection measures. Nonetheless, in addition to the residual risk of bacterial injection of platelet concentrates and parasitic infection of red cell concentrates, there is the emerging danger associated with new viruses. Pathogen inactivation based on chemical or photochemical genomic modifications is a broad-spectrum approach. These techniques are already used to inactivate plasma, and are being developed or application to platelet and erythrocyte concentrates. Universal inactivation of all labile blood products should be possible in a few years' time, but clinical and hemovigilance studies must first show that the biological properties and therapeutic efficacy of these products are not markedly affected, and that the methods used do not lead to long-term toxicity.

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

    PubMed

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

    2015-12-01

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

  18. Quality assurance

    SciTech Connect

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

    1995-06-01

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

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

    PubMed

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

    2013-03-01

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

  20. Quality Interaction Between Mission Assurance and Project Team Members

    NASA Technical Reports Server (NTRS)

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

    2006-01-01

    This viewgraph presentation demonstrates the importance of value added Mission Assurance to flight operations in order to assure mission success and the Health and Safety of the mission, (i.e., the Spitzer space Telescope.)

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

    PubMed

    Cheung, Tommy Tsang; Cheung, Bernard Man Yung

    2014-01-01

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

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

    PubMed

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

    2009-01-01

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

  3. Mechanism and Safety at the Threshold of the Blood-Brain Barrier Opening In Vivo

    NASA Astrophysics Data System (ADS)

    Konofagou, Elisa E.; Choi, James; Baseri, Babak; Selert, Kirsten; Tung, Yao-Sheng

    2010-03-01

    Current treatments of neurological and neurodegenerative diseases are limited due to the blood-brain barrier (BBB). In this paper, the threshold of BBB opening and its dependence on the microbubble diameter as well as the associated mechanism and safety are identified in vivo. In vivo BBB opening in mice (n = 13) was achieved by systemically injecting microbubbles (Definity and 1-2 and 4-5-μm lipid-shelled, gas-filled) and applying pulsed FUS (frequency: 1.525 MHz, peak-rarefactional pressure: 150-600 kPa) to the left hippocampus through the intact skin and skull. Systemically administered, BBB-impermeable, fluorescent-tagged dextrans at 3 kDa were injected to confirm BBB opening. H&E histology was also performed to determine any associated vascular or neuronal damage. Detection of stable and inertial cavitation was performed using a passive cavitation device (PCD) in a blood vessel phantom at the same pressure amplitudes as those used in vivo. Larger microbubbles (4-5 μm) resulted in a lower threshold of BBB opening. Cavitation studies confirmed that stable cavitation occurs at the threshold of BBB opening. The mechanism of BBB opening at the threshold was identified to be mainly related to stable cavitation. Histological studies indicated that, at the BBB opening threshold, no red-blood cell extravasation or neuronal damage was noted.

  4. 30 CFR 15.8 - Quality assurance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 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...

  5. 30 CFR 7.7 - Quality assurance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 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...

  6. 30 CFR 14.8 - Quality assurance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Quality assurance. 14.8 Section 14.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... Quality assurance. Applicants granted an approval or an extension of approval under this Part must: (a)...

  7. 30 CFR 15.8 - Quality assurance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 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...

  8. 30 CFR 7.7 - Quality assurance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  9. 30 CFR 15.8 - Quality assurance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 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...

  10. 30 CFR 15.8 - Quality assurance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 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...

  11. 30 CFR 15.8 - Quality assurance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  12. 30 CFR 14.8 - Quality assurance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Quality assurance. 14.8 Section 14.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... Quality assurance. Applicants granted an approval or an extension of approval under this Part must: (a)...

  13. 30 CFR 7.7 - Quality assurance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 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...

  14. 30 CFR 7.7 - Quality assurance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 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...

  15. 30 CFR 7.7 - Quality assurance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 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...

  16. 30 CFR 14.8 - Quality assurance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Quality assurance. 14.8 Section 14.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... Quality assurance. Applicants granted an approval or an extension of approval under this Part must: (a)...

  17. 30 CFR 14.8 - Quality assurance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Quality assurance. 14.8 Section 14.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... Quality assurance. Applicants granted an approval or an extension of approval under this Part must: (a)...

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

    PubMed

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

    2006-07-01

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

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

    PubMed

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

    2011-04-22

    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.

  20. Assuring quality.

    PubMed

    Eaton, K A; Reynolds, P A; Mason, R; Cardell, R

    2008-08-09

    All those involved in education have a strong motivation to ensure that all its aspects, including content and teaching practice, are of the highest standard. This paper describes how agencies such as the Quality Assurance Agency for Higher Education (QAA) and the General Dental Council (GDC) have established frameworks and specifications to monitor the quality of education provided in dental schools and other institutes that provide education and training for dentists and dental care professionals (DCPs). It then considers quality issues in programme and course development, techniques for assessing the quality of education, including content and presentation, and the role of students. It goes on to review the work that has been done in developing quality assessment for distance learning in dentistry. It concludes that, to date, much of the work on quality applies to education as a whole and that the assessment of the quality of e-learning in dentistry is in its infancy.

  1. Seroprevalence of Antibodies to Ross River and Barmah Forest Viruses: Possible Implications for Blood Transfusion Safety After Extreme Weather Events.

    PubMed

    Faddy, Helen; Dunford, Melanie; Seed, Clive; Olds, Andrew; Harley, David; Dean, Melinda; Racloz, Vanessa; McCarthy, Suzi; Smith, David; Flower, Robert

    2015-06-01

    Climate change is predicted to increase the transmission of many vector-borne pathogens, representing an increasing threat to a safe blood supply. In early 2011, Australia experienced catastrophic rainfall and flooding, coupled with increased arbovirus transmission. We used Ross River (RRV) and Barmah Forest (BFV) viruses as test cases to investigate the potential risk posed to Australia's blood supply after this period of increased rainfall . We estimated the risk of collecting an infected donation as one in 2,500-58,000 for RRV and one in 2,000-28,000 for BFV. Climate change may incrementally increase the arbovirus threat to blood safety.

  2. 10 CFR 830.121 - Quality Assurance Program (QAP).

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Quality Assurance Program (QAP). 830.121 Section 830.121 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.121 Quality... the Quality Assurance criteria in § 830.122. (b) The contractor responsible for a DOE nuclear...

  3. 49 CFR 180.505 - Quality assurance program.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 3 2014-10-01 2014-10-01 false Quality assurance program. 180.505 Section 180.505 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY... Qualification and Maintenance of Tank Cars § 180.505 Quality assurance program. The quality assurance...

  4. 10 CFR 830.121 - Quality Assurance Program (QAP).

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Quality Assurance Program (QAP). 830.121 Section 830.121 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.121 Quality... the Quality Assurance criteria in § 830.122. (b) The contractor responsible for a DOE nuclear...

  5. 49 CFR 180.505 - Quality assurance program.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 3 2011-10-01 2011-10-01 false Quality assurance program. 180.505 Section 180.505 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY... Qualification and Maintenance of Tank Cars § 180.505 Quality assurance program. The quality assurance...

  6. 10 CFR 830.122 - Quality assurance criteria.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false Quality assurance criteria. 830.122 Section 830.122 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.122 Quality assurance...) Criterion 3—Management/Quality Improvement. (1) Establish and implement processes to detect and...

  7. 10 CFR 830.122 - Quality assurance criteria.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Quality assurance criteria. 830.122 Section 830.122 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.122 Quality assurance...) Criterion 3—Management/Quality Improvement. (1) Establish and implement processes to detect and...

  8. Multilayer-strategy to enhance optimal safety of the blood supply: The role of pathogen inactivation for optimizing recipient safety and helping health care cost containment: Moderator views.

    PubMed

    Seghatchian, Jerard

    2015-04-01

    This brief paper is based on the Coimbra 'conference presentation by the moderator', prior to the two main lectures on pathogen reduction treatment [PRT] of plasma. Being an educationist and teacher in core and having a great interest to simplify the message convey to conference' participants and readers I decided to maintain the slide format of the presentation. To highlight most effectively the role played by pathogen reduction to supplement the multilayer-strategy already in place, emphasizes were placed by going back to basic focusing on: where we were, where we are now and where we are going!. The unresolved problems of viral safety of blood components and criteria of universal acceptability of PRT are highlighted so is the need for further DDR strategies both in incremental and innovative ways. Finally the issue of who would benefit from implementation of PRT is described based on published data and also providing some visionary foresights for the long term benefits of PRT in both optimizing the safety of blood supply and helping at least in health care containment. I hope this new approach will be useful to readers, providing at least some conceptual and technical supports in understanding the role of PRT in optimizing the safety of blood supply.

  9. Product assurance management and software product assurance

    NASA Technical Reports Server (NTRS)

    Schneider, C.; Borycki, G.; Panaroni, P.; Surbone, M.; Borcz, R.; Beddow, A. J.

    1991-01-01

    The evolution of software assurance is discussed. The definition and implementation of standards are considered. It is recommended that requirements be clarified at the start of a project. The need for quality assurance in hardware is identified as the coming trend in the production of high cost single units which call for eradication of all errors during the early stages of development. The need to apply quality assurance throughout the whole mission is stressed. The dangers of overpricing product assurance services is stressed.

  10. Blood safety implications of donors using HIV pre-exposure prophylaxis.

    PubMed

    Seed, C R; Yang, H; Lee, J F

    2017-03-31

    HIV pre-exposure prophylaxis (PrEP) is the use of one or more antiretroviral medications (in combination) to prevent HIV infection. The most commonly used PrEP medication (Truvada(®) , Gilead Sciences, Inc.) acts by inhibiting HIV-1 reverse transcriptase. If someone who is using PrEP unknowingly becomes HIV infected (termed 'PrEP breakthrough infection'), there may be suppressed viral replication resulting in a virus level undetectable by the most sensitive HIV NAT. Failure to seroconvert and seroreversion (loss of previously detectable HIV antibodies) have also both been observed with 2nd, 3rd and 4th generation screening immunoassays, as well as Western blot assays. If such a person was tested in the course of donating blood, the results may therefore be difficult to interpret. The index of suspicion for possible PrEP 'interference' should be highest in the context of concomitant low-level positive or 'greyzone' reactivity on HIV NAT and serological tests, which is an unusual pattern in acutely HIV-infected blood donors. Another possibility is detectable HIV RNA with negative HIV serology (i.e. a potential 'NAT yield' case) but without subsequent HIV seroconversion (or disappearance of HIV RNA). Excluding antiretroviral therapy or PrEP use by the donor in such circumstances would be important. The current rarity of PrEP breakthrough infection indicates that any potential safety risk is likely very small. However, considering the increasing use of PrEP we feel it is prudent for those interpreting HIV donor screening test results to consider the potential for PrEP interference.

  11. Safety of blood transfusions using 27 gauge neonatal PICC lines: an in vitro study on hemolysis.

    PubMed

    Repa, A; Mayerhofer, M; Cardona, F; Worel, N; Deindl, P; Pollak, A; Berger, A; Haiden, N

    2013-12-01

    Blood transfusions are required by the majority of extremely premature infants. Packed red blood cells (PRBCs) are usually applied via simple peripheral cannulas. In situations where no peripheral venous access is achievable, 27 Gauge (G) neonatal PICC lines - that are ideally exclusively dedicated to application of parenteral nutrition - may represent a useful alternative access for PRBC transfusions. However, transfusion via small scaled catheters may damage PRBCs and lead to hemolysis. We here evaluate whether transfusion of irradiated PRBCs via 27 G PICC lines leads to hemolysis in vitro.Experimental transfusions of gamma-irradiated PRBCs were performed at increasing velocities (2.5, 3.7, 5 ml/h; full force manual push approximating 30 ml/h) via 27 G PICC lines of 20 and 30 cm length. Parameters of hemolysis (lactate dehydrogenase, potassium and free hemoglobin) were measured from the supernatants of transfused PRBCs and the percentage of hemolysis was calculated.Potassium and lactate dehydrogenase after transfusion at increasing velocities did not differ significantly from negative controls. Free hemoglobin levels showed a small but significant increase at the slowest transfusion speed (2.5 ml/h) using the 30 cm 27 G PICC line, with a relative hemolysis of only 0.13%. A manual push (approximating 30 ml/h) showed no significant changes of parameters from baseline.We conclude that transfusion of gamma-irradiated PRBCs using a 27 G neonatal PICC line does not cause clinically relevant hemolysis in vitro. Clinical studies are needed to confirm the feasibility and safety of the approach in vivo.

  12. Blood

    MedlinePlus

    ... The liquid part, called plasma, is made of water, salts, and protein. Over half of your blood is plasma. The solid part of your blood contains red blood cells, white blood cells, and platelets. Red ...

  13. Safety Evaluation of Hemoglobin-Albumin Cluster “HemoAct” as a Red Blood Cell Substitute

    PubMed Central

    Haruki, Risa; Kimura, Takuya; Iwasaki, Hitomi; Yamada, Kana; Kamiyama, Ikuo; Kohno, Mitsutomo; Taguchi, Kazuaki; Nagao, Saori; Maruyama, Toru; Otagiri, Masaki; Komatsu, Teruyuki

    2015-01-01

    A hemoglobin (Hb) wrapped covalently by human serum albumins (HSAs), a core–shell structured hemoglobin-albumin cluster designated as “HemoAct”, is an O2-carrier designed for use as a red blood cell (RBC) substitute. This report describes the blood compatibility, hemodynamic response, and pharmacokinetic properties of HemoAct, and then explains its preclinical safety. Viscosity and blood cell counting measurements revealed that HemoAct has good compatibility with whole blood. Intravenous administration of HemoAct into anesthetized rats elicited no unfavorable increase in systemic blood pressure by vasoconstriction. The half-life of 125I-labeled HemoAct in circulating blood is markedly longer than that of HSA. Serum biochemical tests conducted 7 days after HemoAct infusion yielded equivalent values to those observed in the control group with HSA. Histopathologic inspections of the vital organs revealed no marked abnormality in their tissues. All results indicate that HemoAct has sufficient preclinical safety as an alternative material for RBC transfusion. PMID:26220366

  14. Assured Crew Return Vehicle

    NASA Technical Reports Server (NTRS)

    Stone, D. A.; Craig, J. W.; Drone, B.; Gerlach, R. H.; Williams, R. J.

    1991-01-01

    The developmental status is discussed regarding the 'lifeboat' vehicle to enhance the safety of the crew on the Space Station Freedom (SSF). NASA's Assured Crew Return Vehicle (ACRV) is intended to provide a means for returning the SSF crew to earth at all times. The 'lifeboat' philosophy is the key to managing the development of the ACRV which further depends on matrixed support and total quality management for implementation. The risk of SSF mission scenarios are related to selected ACRV mission requirements, and the system and vehicle designs are related to these precepts. Four possible ACRV configurations are mentioned including the lifting-body, Apollo shape, Discoverer shape, and a new lift-to-drag concept. The SCRAM design concept is discussed in detail with attention to the 'lifeboat' philosophy and requirements for implementation.

  15. Beef Quality Assurance in Feedlots.

    PubMed

    Smith, Robert A; Thomson, Daniel U; Lee, Tiffany L

    2015-07-01

    This article discusses the Beef Quality Assurance (BQA) program, which was created by beef producers and veterinarians. The program has evolved from antibiotic residue avoidance to include animal handling, cattle comfort, food safety, and much more. It provides guidance to producers and veterinarians on best management practices and allows the beef industry to be transparent about the practices used. Veterinarians are key to helping producers implement BQA in their beef operations.

  16. Blood

    MedlinePlus

    ... that die or are lost from the body. White Blood Cells White blood cells (WBCs, and also ... of severe pain. previous continue Diseases of the White Blood Cells Neutropenia (pronounced: new-truh-PEE-nee- ...

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

    SciTech Connect

    S. T. Khericha; R. C. Pedersen

    2003-09-01

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

  18. Redefining and expanding quality assurance.

    PubMed

    Robins, J L

    1992-12-01

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

  19. Safety.

    ERIC Educational Resources Information Center

    Education in Science, 1996

    1996-01-01

    Discusses safety issues in science, including: allergic reactions to peanuts used in experiments; explosions in lead/acid batteries; and inspection of pressure vessels, such as pressure cookers or model steam engines. (MKR)

  20. Efficacy and safety of DALI LDL-apheresis at high blood flow rates: a prospective multicenter study.

    PubMed

    Wendler, T; Schilling, R; Lennertz, A; Sodemann, K; Kleophas, W; Messner, H; Riechers, G; Wagner, J; Keller, C; Bosch, T

    2003-01-01

    Direct adsorption of lipids (DALI) is the first LDL-apheresis method compatible with whole blood. Usually, the blood flow rate is adjusted at 60-80 ml/min, which results in session times of about 2 hr. The present study was performed to test the safety and efficacy of low-density lipoprotein cholesterol (LDL-C) and lipoprotein (a) [Lp(a)] removal by DALI at high blood flow rates in order to reduce treatment time. Thirteen chronic DALI patients in seven centers suffering from hypercholesterolemia (LDL-C 162 +/- 42 mg/dl at baseline) and coronary artery disease were treated on a weekly or biweekly basis by DALI apheresis. The blood flow rate QB was held constant for at least two sessions, respectively, and was increased from 60 to 80, 120, 160, 200, and 240 ml/min. All patients had pre-existing av-fistulas. The anticoagulation was performed by a heparin bolus plus ACD-A at a ratio of citrate:blood ranging from 1:20 to 1:90. Clinically, the sessions were well tolerated and only 26/201 sessions (12%) of the treatments were fraught with minor adverse events. Acute LDL-C reductions (derived from LDL-C levels determined by lipoprotein electrophoresis) averaged 72/66/60/53/50/48% for QB=60/80/120/160/200/240 ml/min. Lp(a) reductions were 68/67/62/60/58/56%, whereas HDL-C losses were < or =10%. Routine blood chemistries and blood cell counts remained in the normal range. Treatment times averaged 142/83/45 min at Qb=60/120/240 ml/min. On average, DALI LDL-apheresis could be performed safely and effectively at high blood flow rates up to at least 120 ml/min in patients with good blood access, which significantly reduced treatment time from 142 to 83 min (-42%).

  1. Risk management in primary apicultural production. Part 2: a Hazard Analysis Critical Control Point approach to assuring the safety of unprocessed honey.

    PubMed

    Formato, Giovanni; Zilli, Romano; Condoleo, Roberto; Marozzi, Selene; Davis, Ivor; Smulders, Frans J M

    2011-06-01

    In managing risks associated with the human consumption of honey, all sectors of the production chain must be considered, including the primary production phase. Although the introduction of the Hazard Analysis Critical Control Point (HACCP) system has not been made compulsory for purposes of quality and safety control in farming operations, European legislation makes many references to the key role of primary production in food safety management and the HACCP system has been indicated as the preferred tool to ensure that consumers are provided with safe foods. This article describes a systematic HACCP-based approach to identifying, preventing and controlling food safety hazards occurring in primary apicultural production. This approach serves as a useful tool for beekeepers, food business operators, veterinary advisors, and for Food and Veterinary Official Control Bodies in their planning and conducting of audits and for establishing priorities for the evaluation of training programmes in the apicultural sector.

  2. Rebuilding a safety culture

    NASA Astrophysics Data System (ADS)

    Rodney, George A.

    1991-11-01

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

  3. Challenges in High-Assurance Runtime Verification

    NASA Technical Reports Server (NTRS)

    Goodloe, Alwyn E.

    2016-01-01

    Safety-critical systems are growing more complex and becoming increasingly autonomous. Runtime Verification (RV) has the potential to provide protections when a system cannot be assured by conventional means, but only if the RV itself can be trusted. In this paper, we proffer a number of challenges to realizing high-assurance RV and illustrate how we have addressed them in our research. We argue that high-assurance RV provides a rich target for automated verification tools in hope of fostering closer collaboration among the communities.

  4. Compliance Assurance Monitoring

    EPA Pesticide Factsheets

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

  5. Reliability assurance for regulation of advanced reactors

    SciTech Connect

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

    1991-12-31

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

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

    SciTech Connect

    Khericha, Soli T

    2002-06-01

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

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

    SciTech Connect

    Khericha, S.T.

    2002-06-30

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

  8. Multinational Quality Assurance

    ERIC Educational Resources Information Center

    Kinser, Kevin

    2011-01-01

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

  9. 78 FR 28848 - Meeting of the Advisory Committee on Blood and Tissue Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-16

    ... delivery in the era of health care reform. In particular, the Committee hopes to address the services currently performed by blood centers that are essential to the U.S. health care system, how anticipated changes in health care may affect blood centers and the provision of services, as well as how the field...

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

    PubMed Central

    Gupta, Anshu; Gupta, Chhavi

    2016-01-01

    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. PMID:27011668

  11. Real-time blood cross-matching sensor for intelligent management of transfusion safety.

    PubMed

    Ramasubramanian, M K; Anthony, Steven R

    2004-01-01

    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.

  12. Manufacturing blood ex vivo: a futuristic approach to deal with the supply and safety concerns

    PubMed Central

    Singh, Vimal K.; Saini, Abhishek; Tsuji, Kohichiro; Sharma, P. B.; Chandra, Ramesh

    2014-01-01

    Blood transfusions are routinely done in every medical regimen and a worldwide established collection, processing/storage centers provide their services for the same. There have been extreme global demands for both raising the current collections and supply of safe/adequate blood due to increasingly demanding population. With, various risks remain associated with the donor derived blood, and a number of post collection blood screening and processing methods put extreme constraints on supply system especially in the underdeveloped countries. A logistic approach to manufacture erythrocytes ex-vivo by using modern tissue culture techniques have surfaced in the past few years. There are several reports showing the possibilities of RBCs (and even platelets/neutrophils) expansion under tightly regulated conditions. In fact, ex vivo synthesis of the few units of clinical grade RBCs from a single dose of starting material such as umbilical cord blood (CB) has been well established. Similarly, many different sources are also being explored for the same purpose, such as embryonic stem cells, induced pluripotent stem cells. However, the major concerns remain elusive before the manufacture and clinical use of different blood components may be used to successfully replace the present system of donor derived blood transfusion. The most important factor shall include the large scale of RBCs production from each donated unit within a limited time period and cost of their production, both of these issues need to be handled carefully since many of the recipients among developing countries are unable to pay even for the freely available donor derived blood. Anyways, keeping these issues in mind, present article shall be focused on the possibilities of blood production and their use in the near future. PMID:25364733

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

    PubMed

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

    2017-02-23

    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

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

    SciTech Connect

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

    1991-10-01

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

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

    SciTech Connect

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

    1991-10-01

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

  16. Saving Lives, Maintaining Safety, and Science-Based Policy: Qualitative Interview Findings from the Blood Donation Rules Opinion Study (Blood DROPS)

    PubMed Central

    Siedle-Khan, Bob; Custer, Brian

    2015-01-01

    Background Indefinite deferral from donation for any man who discloses having had sex with another man even once since 1977 (MSM77) is the US FDA’s standing policy. This qualitative component of the Blood Donation Rules and Opinion Study was designed to provide insight into the perceptions and practices of current or previous donors with MSM history. Methods Forty HIV-negative MSM completed an online survey, indicating they had donated blood and were willing to be interviewed. Semi-structured, individual interviews with these key informants covered donation experience and motivations, perceptions of MSM77, policy change preferences, and possible impact of a change to a time-limited deferral. Transcripts were coded deductively and inductively, following a modified Grounded Theory approach. Analysis identified recurrent and divergent themes. Results Ninety-five percent of participants endorsed modifying MSM77. Preferred deferral length ranged from none to five years; a common opinion was that a science-based deferral period would be less than one year. Other policy change recommendations included incorporating questions about specific HIV risk behaviors to the donor questionnaire for all potential donors. Interviewees recognized HIV infection rates are higher in MSM than the general US population, but participants considered themselves low-risk for HIV, donated blood “to save lives”, and justified their recommendations as being more effective ways to identify donors at-risk for HIV. Conclusion Results suggest that MSM donors are concerned with blood safety; they can be appealed to as such. Communications about a new deferral policy should include scientific explanations and acknowledge altruistic motivations of potential donors. PMID:26271755

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

    PubMed

    Porcella, Aleta; Walker, Kristy

    2005-01-01

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

  18. Efficacy and Safety of Frozen Blood for Transfusion in Trauma Patients - A Multi-Center Trial

    DTIC Science & Technology

    2015-04-01

    C, Maginnis M, et al. Does the storage time of transfused red blood cells influence regional or global indexes of tissue oxygenation in anemic...64. Berezina TL, Zaets SB, Morgan C, Spillert CR, Kamiyama M, et al. Influence of storage on red blood cell rheological properties. J Surg Res...transfusion viability to deformability of stored red cells . Br J Haematol. 1983; 53(2):237-240. 68. Parthasarathi K, Lipowsky HH. Capillary

  19. Assessment of Cardiac Troponin I Responses in Nonhuman Primates during Restraint, Blood Collection, and Dosing in Preclinical Safety Studies.

    PubMed

    Reagan, William J; Barnes, Robert; Harris, Peter; Summers, Sandy; Lopes, Sarah; Stubbs, Makeida; Blackwell, David; Steidl-Nichols, Jill

    2017-02-01

    Limited information has been published on the use of cardiac troponin I (cTnI) as a biomarker of cardiac injury in monkeys. The purpose of these studies was to characterize the cTnI response seen in cynomolgus macaques during routine dosing and blood collection procedures typically used in preclinical safety studies and to better understand the pathogenesis of this response. We measured cTnI using two different methods, the Siemens Immulite cTnI assay and the more sensitive Siemens Troponin I-Ultra assay. We were able to demonstrate that after oral, subcutaneous, or intravenous dosing of common vehicles, as well as serial chair restraint for venipuncture blood collection, that minimal to mild transient increases in cTnI could be detected in monkeys with both assays. cTnI values typically peaked at 2, 3, 4, or 6 hr after sham dosing and returned to baseline at 22 or 24 hr. In addition, marked increases in heart rate (HR) and blood pressure (BP) occurred in monkeys during the restraint procedures, which likely initiated the cTnI release in these animals. Monkeys that were very well acclimated to the chairing procedures and had vascular access ports for blood sampling did not have marked increases in HRs and BP or increases in cTnI.

  20. Nuclear Powerplant Safety: Operations.

    ERIC Educational Resources Information Center

    Department of Energy, Washington, DC. Nuclear Energy Office.

    Powerplant systems and procedures that ensure the day-to-day health and safety of people in and around the plant is referred to as operational safety. This safety is the result of careful planning, good engineering and design, strict licensing and regulation, and environmental monitoring. Procedures that assure operational safety at nuclear…

  1. High assurance SPIRAL

    NASA Astrophysics Data System (ADS)

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

    2014-06-01

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

  2. Safety of large-volume leukapheresis for collection of peripheral blood progenitor cells.

    PubMed

    Reik, R A; Noto, T A; Fernandez, H F

    1997-01-01

    Large volume leukapheresis (LVL) reduces the number of procedures required to obtain adequate peripheral blood progenitor cells (PBPCs) for autologous hematopoietic reconstitution. LVL involves the processing of > 15 L or 5 patient blood volumes using high flow rates. We report our experience with LVL evaluating its efficiency and adverse effects in 71 adult patients with hematologic or solid organ malignancies. All were mobilized with chemotherapy and granulocyte colony-stimulating factor (G-CSF). All collections used a double lumen apheresis catheter. Mean values per LVL were as follows: blood processed, 24.6 L; patient blood volumes processed, 5.9; ACD-A used, 1,048 ml; heparin used, 6,148 units; collect time, 290 min; blood flow rate, 89 ml/min. Eighty percent of the collections were completed in one or two procedures to obtain > or = 6.0 x 10(8) MNCs/kg body weight. The most frequent side effect (39%) was parasthesia due to citrate-related hypocalcemia. This was managed with oral calcium supplements and/or slower flow rates. Post-LVL electrolyte changes were generally asymptomatic. Prophylactic oral potassium supplements were administered in 57% of cases. Other reactions included hypotension (4%), prolonged parasthesia (1.4%), and headache (1.4%). Catheter problems in 9 (13%) of the procedures were attributed to clot formation (37%) or positional effects (63%). No bleeding occurred. Post-LVL decreases in hematocrit and platelet count averaged 3.5% and 46%, respectively. Six (4%) of the procedures required red blood cell transfusions. Platelet transfusions were given in 19 (13%) of the procedures. We conclude that adverse reactions with LVL are similar to those reported for conventional PBPC collections, making it safe and efficacious as an outpatient procedure.

  3. [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].

    PubMed

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

    2004-03-01

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

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

    PubMed

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

    2013-03-01

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

  5. 40 CFR 1603.5 - Assurance of compliance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 32 2010-07-01 2010-07-01 false Assurance of compliance. 1603.5 Section 1603.5 Protection of Environment CHEMICAL SAFETY AND HAZARD INVESTIGATION BOARD RULES IMPLEMENTING THE GOVERNMENT IN THE SUNSHINE ACT § 1603.5 Assurance of compliance. (a) The General Counsel...

  6. 10 CFR 830.121 - Quality Assurance Program (QAP).

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Quality Assurance Program (QAP). 830.121 Section 830.121 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.121 Quality..., unless it is approved or rejected by DOE at an earlier date. (2) Modify the QAP as directed by DOE....

  7. 10 CFR 830.121 - Quality Assurance Program (QAP).

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 4 2012-01-01 2012-01-01 false Quality Assurance Program (QAP). 830.121 Section 830.121 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.121 Quality..., unless it is approved or rejected by DOE at an earlier date. (2) Modify the QAP as directed by DOE....

  8. 10 CFR 830.121 - Quality Assurance Program (QAP).

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false Quality Assurance Program (QAP). 830.121 Section 830.121 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.121 Quality..., unless it is approved or rejected by DOE at an earlier date. (2) Modify the QAP as directed by DOE....

  9. Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents

    PubMed Central

    Gonzalez, Daniel; Palazzi, Debra L.; Bhattacharya-Mithal, Leena; Al-Uzri, Amira; James, Laura P.; Bradley, John; Neu, Natalie; Jasion, Theresa; Hornik, Christoph P.; Smith, P. Brian; Benjamin, Daniel K.; Keedy, Kara; Fernandes, Prabhavathi

    2016-01-01

    We assessed the pharmacokinetics and safety of solithromycin, a fluoroketolide antibiotic, in a phase 1, open-label, multicenter study of 13 adolescents with suspected or confirmed bacterial infections. On days 3 to 5, the mean (standard deviation) maximum plasma concentration and area under the concentration versus time curve from 0 to 24 h were 0.74 μg/ml (0.61 μg/ml) and 9.28 μg · h/ml (6.30 μg · h/ml), respectively. The exposure and safety in this small cohort of adolescents were comparable to those for adults. (This study has been registered at ClinicalTrials.gov under registration no. NCT01966055.) PMID:26883693

  10. 77 FR 67012 - Meeting of the Advisory Committee on Blood and Tissue Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-08

    ... Infectious Disease Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human... Health. ACTION: Notice. SUMMARY: As stipulated by the Federal Advisory Committee Act, the U.S. Department..., Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Senior Advisor for Blood Policy...

  11. Safety and Tolerability of HSC835 in Patients Undergoing Single Umbilical Cord Blood Transplant

    ClinicalTrials.gov

    2017-04-04

    Single Umbilical Cord Blood Transplantation; Non-myeloablative Conditioning; Acute Myelocytic Leukemia; Acute Lymphocytic Leukemia; Chronic Myelogenous Leukemia; Myelodysplastic Syndrome; Chronic Lymphocytic Leukemia; Marginal Zone Lymphoma; Follicular Lymphomas; Large-cell Lymphoma; Hodgkin Lymphoma; Multiple Myeloma; Lymphoblastic Lymphoma; Burkitt's Lymphoma; Mantle-cell Lymphoma; Lymphoplasmacytic Lymphoma; Prolymphocytic Leukemia

  12. Small satellite product assurance

    NASA Astrophysics Data System (ADS)

    Demontlivault, J.; Cadelec, Jacques

    1993-01-01

    In order to increase the interest in small satellites, their cost must be reduced; reducing product assurance costs induced by quality requirements is a major objective. For a logical approach, small satellites are classified in three main categories: satellites for experimental operations with a short lifetime, operational satellites manufactured in small mass with long lifetime requirements, operational satellites (long lifetime required), of which only a few models are produced. The various requirements as regards the product assurance are examined for each satellite category: general requirements for space approach, reliability, electronic components, materials and processes, quality assurance, documentation, tests, and management. Ideal product assurance system integrates quality teams and engineering teams.

  13. 20 CFR 655.203 - Assurances.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... include assurances, signed by the employer, that: (a) The job opportunity is not: (1) Vacant because the... laws, including employment related health and safety laws; (c) The job opportunity is open to all... least two advertisements for the job opportunities in local newspapers of general circulation. (i)...

  14. 10 CFR 72.142 - Quality assurance organization.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  15. 10 CFR 72.142 - Quality assurance organization.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

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

    PubMed

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

    2016-02-01

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

  17. Efficacy and Safety of Frozen Blood for Transfusion in Trauma Patients

    DTIC Science & Technology

    2012-11-01

    benefits of cryopreserved blood have been well documented in the military and civilian settings. The biochemical benefits of this storage technique ...Hemoglobin was analyzed by ELISA (Bethyl Laboratories, Montgomery, TX). Haptoglobin, serum amyloid P (SAP) and C-reative protein ( CRP ) were evaluated...utilizing the Bio-Plex Pro Human Acute Phase 4-Plex Panel (Bio-Rad Laboratories Inc., Hercules, CA). SAP and CRP were studied due to their known anti

  18. Towards Run-time Assurance of Advanced Propulsion Algorithms

    NASA Technical Reports Server (NTRS)

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

    2014-01-01

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

  19. Quality assurance for gamma knives

    SciTech Connect

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

    1995-09-01

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

  20. Development and Implementation Challenges of a Quality Assured HIV Infant Diagnosis Program in Nigeria Using Dried Blood Spots and DNA Polymerase Chain Reaction

    PubMed Central

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

    2015-01-01

    Nigeria has one of the highest HIV burdens as well as mother-to-infant transmission rates in the world. A pilot program using polymerase chain reaction (PCR)-based testing of dried blood spot (DBS) specimens was implemented to enable early identification of HIV-infected infants and timely referral and linkage to care. From February 2007 to October 2008, whole blood was collected by finger prick to prepare DBS from infants < 18 months presenting in six public mother-and-child health facilities in Lagos, Nigeria. The DBS were tested using the Roche Amplicor HIV-1 DNA Test, v1.5. To monitor laboratory testing quality, all of the PCR-positive and 10% of the PCR-negative DBS were retested by the same method at another reference laboratory. Three hundred and sixty-five randomly selected infants were screened using HIV rapid tests (RT) according to the national algorithm and RT-negative and PCR-positive specimens were also tested using Genscreen enzyme-linked immunosorbent assay (EIA) (Bio-Rad, France). The turnaround time (TAT) from sample collection, testing, and dispatching of results from each health facility was monitored. A total of 1,273 infants with a median age of 12.6 weeks (1 day to 71.6 weeks) participated in the program and 280 (22.0%) were PCR positive. HIV transmission levels varied greatly in the different health facilities ranging from 7.1% to 38.4%. Infants aged 48 to 72 weeks had the highest level of PCR positivity (41.1%). All PCR-positive specimens were confirmed by retesting. The mean turnaround time from DBS collection to returning of the laboratory result to the health facilities was 25 days. Three infants were found to be HIV antibody negative by rapid tests but were positive by both PCR and the fourth generation EIA. The DBS-based PCR program accurately identified all of the HIV-infected infants. However, many programmatic challenges related to the laboratory and TAT were identified. PMID:25381805

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

    PubMed

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

    2015-04-01

    Nigeria has one of the highest HIV burdens as well as mother-to-infant transmission rates in the world. A pilot program using polymerase chain reaction (PCR)-based testing of dried blood spot (DBS) specimens was implemented to enable early identification of HIV-infected infants and timely referral and linkage to care. From February 2007 to October 2008, whole blood was collected by finger prick to prepare DBS from infants <18 months presenting in six public mother-and-child health facilities in Lagos, Nigeria. The DBS were tested using the Roche Amplicor HIV-1 DNA Test, v1.5. To monitor laboratory testing quality, all of the PCR-positive and 10% of the PCR-negative DBS were retested by the same method at another reference laboratory. Three hundred and sixty-five randomly selected infants were screened using HIV rapid tests (RT) according to the national algorithm and RT-negative and PCR-positive specimens were also tested using Genscreen enzyme-linked immunosorbent assay (EIA) (Bio-Rad, France). The turnaround time (TAT) from sample collection, testing, and dispatching of results from each health facility was monitored. A total of 1,273 infants with a median age of 12.6 weeks (1 day to 71.6 weeks) participated in the program and 280 (22.0%) were PCR positive. HIV transmission levels varied greatly in the different health facilities ranging from 7.1% to 38.4%. Infants aged 48 to 72 weeks had the highest level of PCR positivity (41.1%). All PCR-positive specimens were confirmed by retesting. The mean turnaround time from DBS collection to returning of the laboratory result to the health facilities was 25 days. Three infants were found to be HIV antibody negative by rapid tests but were positive by both PCR and the fourth generation EIA. The DBS-based PCR program accurately identified all of the HIV-infected infants. However, many programmatic challenges related to the laboratory and TAT were identified.

  2. Immune safety evaluation of polymerized porcine hemoglobin (pPolyHb): a potential red blood cell substitute.

    PubMed

    Zhu, Hongli; Yan, Kunping; Dang, Xiaodong; Huang, He; Chen, Erfang; Chen, Bang; Luo, Chao; Chang, Thomas Ming Swi; Dai, Penggao; Chen, Chao

    2011-12-01

    Polymerized Porcine Hemoglobin (pPolyHb), a hemoglobin-based oxygen carrier (HBOC), was developed as a potential red blood substitute for clinical applications. Assessment of its effects on the immune system is an important component of the overall safety evaluation of HBOC. For this purpose, we assessed three inflammation indicators, including complement C3a, IL-6, and TNF-? in cultured cells and in a rat model when pPolyHb was incubated or administrated with the cells/animals. Our results suggested that the levels of these three indicators were not statistically changed upon pPolyHb stimulation, indicating that pPolyHb is not immunotoxic to cells and animals in this aspect.

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

    PubMed

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

    2016-02-01

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

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

    PubMed

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

    2014-03-01

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

  5. Blood

    MedlinePlus

    ... increased red blood cell destruction can affect teens: G6PD deficiency. G6PD is an enzyme that helps to protect ... can cause red cells to hemolyze, or burst. G6PD deficiency is a common hereditary disease among people of ...

  6. Awareness and performance of blood transfusion standards in operating rooms of Shiraz hospitals in 2012

    PubMed Central

    Robati, R; Mirahmadi Nejad, E

    2015-01-01

    Background Assuring safety and survival of blood in vitro depends on anti-coagulation substances, blood bag characteristics, storage conditions, and transport of blood. Besides, careful selection and screening of donors as well as blood tests can minimize the transmission risk of blood-transmissible pathogens and optimize blood health. The aim of this study was to assay the level of knowledge and practices among anesthesia technicians on blood transfusion standards. Materials and Methods This descriptive cross-sectional study was performed among 85 anesthesia technicians Shiraz, Iran throughout 2012 who were examined by census using blood transfusion questionnaires and checklists. The data were analyzed using SPSS 16 software. Results The obtained findings indicated that 32.44% of the technicians have corrected knowledge of blood transfusion standards; nevertheless, 73.84% have corrected performance. Conclusions The technicians mostly performed based on their habit and experience. However, their knowledge about blood transfusion and blood bag storage was low. PMID:26131349

  7. Technical note: preventive maintenance quality assurance.

    PubMed

    Russell, D

    1992-01-01

    Performance improvements in healthcare and, specifically, in clinical engineering are required by the Joint Commission on the Accreditation of Healthcare Organizations' Plant Technology and Safety Management (PTSM) documents. The goals of healthcare service quality assurance are to establish performance requirements and improve patient outcomes. It is important that these goals be kept in the forefront of the design of clinical engineering quality assurance planning. Indicator/threshold pairs must be carefully chosen on the basis of some logical relation to the desired goals of the overall program.

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

    PubMed

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

    2017-02-01

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

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

    NASA Technical Reports Server (NTRS)

    Evans, John W.; DiVenti, Tony

    2016-01-01

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

  10. Software quality assurance handbook

    SciTech Connect

    Not Available

    1990-09-01

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

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

    NASA Technical Reports Server (NTRS)

    Canfield, Amy

    2016-01-01

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

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

    PubMed

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

    2016-02-01

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

  13. RTOG quality assurance guidelines for interstitial hyperthermia.

    PubMed

    Emami, B; Stauffer, P; Dewhirst, M W; Prionas, S; Ryan, T; Corry, P; Herman, T; Kapp, D S; Myerson, R J; Samulski, T

    1991-05-01

    This document specifies the current recommendations for quality assurance for hyperthermia administration with interstitial techniques as specified by the Radiation Therapy Oncology Group (RTOG). The document begins by providing a brief description of the physical principles behind the use of the three most commonly used methods of interstitial hyperthermia: radiofrequency (RF-LCF), microwave antennas, and ferromagnetic seeds. Emphasis is placed on features that effect quality assurance. Specific recommendations are provided for: a) Pretreatment planning and equipment performance checks, b) Implant considerations and documentation, c) Thermometry, and d) Safety procedures. Specific details regarding quality assurance issues that are common to all local and regional hyperthermia methods are outlined in previous documents sponsored by the RTOG. It is anticipated that technological advances may lead to future modifications of this document.

  14. RAVEN Quality Assurance Activities

    SciTech Connect

    Cogliati, Joshua Joseph

    2015-09-01

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

  15. Performance assurance program plan

    SciTech Connect

    Rogers, B.H.

    1997-11-06

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

  16. Safety and efficacy of packed red blood cell transfusions at different doses in very low birth weight infants

    PubMed Central

    Govande, Vinayak P.; Shetty, Ashita; Beeram, Madhava R.

    2016-01-01

    This double-blinded, randomized, crossover study evaluated the safety and effectiveness of 20 mL/kg aliquots of packed red blood cell (PRBC) transfusions versus 15 mL/kg aliquot transfusions in very low birth weight (VLBW) infants with anemia. The study enrolled 22 hemodynamically stable VLBW infants requiring PRBC transfusions, with a mean gestational age of 25.7 ± 2.2 weeks and birth weight of 804 ± 261 g. Each infant was randomized to receive one of two treatment sequences: 15 mL/kg followed by 20 mL/kg or 20 mL/kg followed by 15 mL/kg. The infants were monitored during and after transfusions, and the efficacy and safety of the treatments were evaluated. Infants had higher posttransfusion hemoglobin (13.2 g/dL vs 11.8 g/dL, P < 0.01) and hematocrit levels (38.6 g/dL vs 34.4 g/dL, P < 0.01) following 20 mL/kg PRBC transfusions when compared to 15 mL/kg transfusions. There were no differences in the incidence of tachypnea, hepatomegaly, edema, hypoxia, necrotizing enterocolitis, or vital sign instability between groups. In conclusion, high-volume PRBC transfusions (20 mL/kg) were associated with higher posttransfusion hemoglobin and hematocrit levels but no adverse effects. Higher-volume transfusions may reduce the need for multiple transfusions and therefore the number of donors the infant is exposed to. PMID:27034542

  17. Quality Assurance: Patient Chart Reviews

    NASA Astrophysics Data System (ADS)

    Oginni, B. M.; Odero, D. O.

    2009-07-01

    Recent developments in radiation therapy have immensely impacted the way the radiation dose is delivered to patients undergoing radiation treatments. However, the fundamental quality assurance (QA) issues underlying the radiation therapy still remain the accuracy of the radiation dose and the radiation safety. One of the major duties of clinical medical physicists in the radiation therapy departments still revolves around ensuring the accuracy of dose delivery to the planning target volume (PTV), the reduction of unintended radiation to normal organs and minimization of the radiation exposure to the medical personnel based on ALARA (as low as reasonably achievable) principle. Many of the errors in radiation therapy can be minimized through a comprehensive program of periodic checks. One of the QA procedures on the patient comes in the form of chart reviews which could be in either electronic or paper-based format. We present the quality assurance procedures that have to be performed on the patient records from the beginning and periodically to the end of the treatment, based on the guidelines from the American Association of Physicists in Medicine (AAPM) and American College of Physicians (ACP).

  18. Requirements for blood and blood components intended for transfusion or for further manufacturing use. Final rule.

    PubMed

    2015-05-22

    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.

  19. Infusion of ex vivo expanded T regulatory cells in adults transplanted with umbilical cord blood: safety profile and detection kinetics.

    PubMed

    Brunstein, Claudio G; Miller, Jeffrey S; Cao, Qing; McKenna, David H; Hippen, Keli L; Curtsinger, Julie; Defor, Todd; Levine, Bruce L; June, Carl H; Rubinstein, Pablo; McGlave, Philip B; Blazar, Bruce R; Wagner, John E

    2011-01-20

    Acute graft-versus-host disease (aGVHD) is associated with high risk of morbidity and mortality and is a common complication after double umbilical cord blood (UCB) transplantation. To reduce these risks, we established a method of CD4(+)CD25(+)FoxP3(+) T regulatory cell (Treg) enrichment from cryopreserved UCB followed by a 18 (+) 1-day expansion culture including anti-CD3/anti-CD28 antibody-coated beads and recombinant human interleukin-2. In a "first-in-human" clinical trial, we evaluated the safety profile of UCB Treg in 23 patients. Patients received a dose of 0.1-30 × 10(5)UCB Treg/kg after double UCB transplantation. The targeted Treg dose was achieved in 74% of cultures, with all products being suppressive in vitro (median 86% suppression at a 1:4 ratio). No infusional toxicities were observed. After infusion, UCB Treg could be detected for 14 days, with the greatest proportion of circulating CD4(+)CD127(-)FoxP3(+) cells observed on day (+)2. Compared with identically treated 108 historical controls without Treg, there was a reduced incidence of grade II-IV aGVHD (43% vs 61%, P = .05) with no deleterious effect on risks of infection, relapse, or early mortality. These results set the stage for a definitive study of UCB Treg to determine its potency in preventing allogeneic aGVHD. This study is registered at http://www.clinicaltrials.gov as NCT00602693.

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

    PubMed Central

    2012-01-01

    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. PMID:22443810

  1. Effect of neo red cells on hemodynamics and blood gas transport in canine hemorrhagic shock and its safety for vital organs.

    PubMed

    Usuba, A; Motoki, R; Sakaguchi, K; Suzuki, K; Kamitani, T

    1994-01-01

    The purpose of this study was to evaluate the effects of liposome encapsulated hemoglobin named "Neo Red Cells (NRC)" on canine hemorrhagic shock model and its safety for the vital organs in a whole blood exchange model. HEMORRHAGIC SHOCK: Nine adult mongrel dogs were used. Under mechanical ventilation inhaling room air, blood was withdrawn via an artery at a rate of 40 ml/min in order to induce hemorrhagic shock (systolic pressure below 60 mm Hg) and then NRC was transfused. For each animal, three to five cycles of bloodletting and NRC transfusion were performed. After blood exchange, total peripheral resistance index (TPRI) decreased and cardiac index (CI) increased. These changes were more marked in the high exchange group (exchange rate over 88%; five animals) than in the low exchange group (less than 88%; four animals), indicating that the low viscosity NRC reduced the load on the circulatory system. The A-V difference in oxygen content per lg hemoglobin was greater after blood exchange, indicating that oxygen binding capacity of NRC is higher than that of red blood cells. WHOLE BLOOD EXCHANGE: Five beagles were used for the blood exchange. The blood was withdrawn from an artery at a rate of 15 ml/min and NRC was infused at the same time. A dog whose blood was exchanged with hydroxyethylstarch instead of NRC died within 15 hours after blood exchange. Three dogs whose blood was exchanged with NRC (exchange rate was from 82 to 90%) have been living over a year without any side effects. A dog sacrificed on the 15th postoperative day for autopsy, microscopically showed no side effects in vital organs. We conclude that NRC is more suitable than natural blood for treatment of hemorrhagic shock and safe for vital organs.

  2. Formal Assurance Arguments: A Solution In Search of a Problem?

    NASA Technical Reports Server (NTRS)

    Graydon, Patrick J.

    2015-01-01

    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.

  3. AVLIS Production Plant Preliminary Quality Assurance Plan and Assessment

    SciTech Connect

    Not Available

    1984-11-15

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

  4. Defining Baconian Probability for Use in Assurance Argumentation

    NASA Technical Reports Server (NTRS)

    Graydon, Patrick J.

    2016-01-01

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

  5. Just in Time Assurance

    DTIC Science & Technology

    2010-04-01

    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

  6. Quality assurance tool: taking a whole-system approach.

    PubMed

    Dowling, Claire; Patel, Seraphim Jr

    2014-11-27

    The London Cancer Alliance (LCA) has developed the Quality Clinical Board Exception Report (QCBER), a tool that supports delivery of quality assurance across its member organisations through its quality assurance framework and escalation protocol. The process improves quality assurance and performance in terms of patient safety, patient satisfaction and clinical outcomes. This article describes how implementation of a robust quality assurance process supported by a simple tool can help healthcare organisations improve patient care and avoid duplication when sharing quality information among providers and across healthcare systems. It also explains how application of the tool can help organisations build evidence of best practice in the five essential Care Quality Commission areas: safety, effectiveness, care, responsiveness and good management.

  7. 49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 5 2012-10-01 2012-10-01 false Will a safety audit result in a safety fitness... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.317 Will a safety audit result in a safety fitness determination by the FMCSA? A safety audit will not result in a...

  8. 49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  9. 49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 5 2014-10-01 2014-10-01 false Will a safety audit result in a safety fitness... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.317 Will a safety audit result in a safety fitness determination by the FMCSA? A safety audit will not result in a...

  10. 49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 5 2011-10-01 2011-10-01 false Will a safety audit result in a safety fitness... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.317 Will a safety audit result in a safety fitness determination by the FMCSA? A safety audit will not result in a...

  11. 49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 5 2013-10-01 2013-10-01 false Will a safety audit result in a safety fitness... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.317 Will a safety audit result in a safety fitness determination by the FMCSA? A safety audit will not result in a...

  12. The limits of sterility assurance.

    PubMed

    von Woedtke, Thomas; Kramer, Axel

    2008-09-03

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

  13. Survey of Software Assurance Techniques for Highly Reliable Systems

    NASA Technical Reports Server (NTRS)

    Nelson, Stacy

    2004-01-01

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

  14. Modified aerospace reliability and quality assurance method for wind turbines

    NASA Technical Reports Server (NTRS)

    Klein, W. E.

    1980-01-01

    The safety, reliability, and quality assurance (SR&QA) approach developed for the first large wind turbine generator project is described. The SR&QA approach was used to assure that the machine would not be hazardous to the public or operating personnel, would operate unattended on a utility grid, would demonstrate reliable operation and would help establish the quality assurance and maintainability requirements for future wind turbine projects. A modified failure modes and effects analysis during the design phase, minimal hardware inspections during parts fabrication, and three simple documents to control activities during machine construction and operation were presented.

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

    NASA Technical Reports Server (NTRS)

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

    1981-01-01

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

  16. Quality Assurance for All

    ERIC Educational Resources Information Center

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

    2010-01-01

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

  17. UST Financial Assurance Information

    EPA Pesticide Factsheets

    Subtitle I of the Resource Conservation and Recovery Act, as amended by the Hazardous Waste Disposal Act of 1984, brought underground storage tanks (USTs) under federal regulation. As part of that regulation, Congress directed EPA to develop financial responsibility regulations for UST owners and operators. Congress wanted owners and operators of underground storage tanks (USTs) to show that they have the financial resources to clean up a site if a release occurs, correct environmental damage, and compensate third parties for injury to their property or themselves.Owners and operators have several options: obtain insurance coverage from an insurer or a risk retention group; demonstrate self-insurance using a financial test; obtain corporate guarantees, surety bonds, or letters of credit; place the required amount into a trust fund administered by a third party; or rely on coverage provided by a state financial assurance fund.Information in this data asset includes state documentation to support this requirement. Many states have developed financial assurance funds to help owners and operators meet financial responsibility requirements and to help cover the costs of cleanups. State financial assurance fund programs, which supplement or are a substitute for private insurance, have been especially useful for small-to-medium sized petroleum marketers.EPA requires its Regional Offices to conduct annual reviews of state financial assurance funds. Data is provided by s

  18. Benchmarking Software Assurance Implementation

    DTIC Science & Technology

    2011-05-18

    product The chicken#. (a.k.a. Process Focused Assessment ) – Management Systems ( ISO 9001 , ISO 27001, ISO 2000) – Capability Maturity Models (CMMI...How – Executive leadership commitment – Translate ROI to project manager vocabulary (cost, schedule, quality ) – Start small and build – Use...collaboration Vocabulary Reserved Words Software Acquisition Information Assurance Project Management System Engineering Software Engineering Software

  19. Information Assurance Study

    DTIC Science & Technology

    1998-01-01

    be a giant step forward. We are aware that the DOD already sponsors 13 Information Analysis Centers (IAC) and the Information Assurance Technology...Norton Anti-Virus Symantec Corporation http://www.symantec.com OfficeScan Trend Micro http://www.antivirus.com Panda Antivirus Panda Software http

  20. Quality assurance program plan for radionuclide airborne emissions monitoring

    SciTech Connect

    Boom, R.J.

    1995-03-01

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

  1. Argument-Based Airworthiness Assurance of Small UAS

    NASA Technical Reports Server (NTRS)

    Denney, Ewen; Pai, Ganesh

    2015-01-01

    Presently, there are three avenues by which Unmanned Aircraft System (UAS) operations are authorized in the U.S. National Airspace System (NAS): obtaining either (i) a certificate of authorization (COA), or (ii) a special airworthiness certificate (SAC) in either the experimental, or the restricted category, or (iii) an exemption from an airworthiness certificate together with a civil COA. The first is meant primarily for public entities, such as NASA; the remaining two are the only available means for civil UAS operations. Recently, the Federal Aviation Administration (FAA) has also proposed a regulatory framework targeted for certain small UAS, specifically those weighing 55 pounds or less, although final rulemaking remains pending. We have previously shown how an assurance case can aggregate heterogeneous reasoning and safety evidence, with application to UAS safety. In this paper, we describe how assurance cases can serve as a common framework to justify overall system safety, unifying both operational aspects and airworthiness, in particular system design assurance. We also show how this approach can coexist with, and augment, existing safety analysis processes and best-practices, by transforming the artifacts they produce into structured assurance arguments. To illustrate the applicability and utility of our approach, we have been applying it for the design assurance of an unmanned rotorcraft system, intended for precision agriculture operations, as part of the NASA Unmanned Aircraft System (UAS) Integration in the National Airspace System (NAS) project.

  2. Quality Assurance for University Teaching.

    ERIC Educational Resources Information Center

    Ellis, Roger, Ed.

    This book, written from a British perspective, presents 17 papers on quality assurance in teaching at the university level. The first eight papers address issues of assuring quality and include: (1) "Quality Assurance for University Teaching; Issues and Approaches" (Roger Ellis); (2) "A British Standard for University…

  3. Quality Assurance in Nursing Homes.

    ERIC Educational Resources Information Center

    Balgopal, Pallassana R.; And Others

    This manual, developed for the nursing home employee, examines the concept of quality assurance in nursing homes, describes the benefits of an effective quality assurance program, and provides guidelines to aid nursing homes in developing an appropriate quality assurance program. After a brief introduction, a working definition of quality…

  4. [Medical quality assurance today].

    PubMed

    Schäfer, Robert D

    2008-01-01

    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.

  5. High Assurance Software

    DTIC Science & Technology

    2013-10-22

    described a publication – Pocket guide for Software Assurance Workforce, Training and Education, Eds. Gandhi , R., Department of Homeland Security (DHS... Gandhi , R. A., Presentation at the SwA Working Group Sessions - MITRE-1, McLean, VA, Bridging to the Future – Emerging Trends in Cybersecurity... Gandhi , R. A., Presentation at the 24th FISSEA’s 24th Annual Conference: March 15 - 17, 2011, National Institute of Standards and Technology Gaithersburg

  6. Software Quality Assurance Metrics

    NASA Technical Reports Server (NTRS)

    McRae, Kalindra A.

    2004-01-01

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

  7. Foundations for Software Assurance

    DTIC Science & Technology

    2013-12-01

    Psychological acceptability: It is essential that the human interface be designed for ease of use, so that users routinely and automatically apply...industries such as banking, medicine and retail . Software assurance is the commonly used term to describe this broader context. The Committee on...Service points out that, ‘The pipeline of new talent [with the skills to ensure the security of software systems] is inadequate. . . . only 40 percent

  8. Specified assurance level sampling procedure

    SciTech Connect

    Willner, O.

    1980-11-01

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

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

    PubMed Central

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

    2013-01-01

    BACKGROUND The goal of selecting a healthy blood donor is to safeguard donors and reduce the risks of infections and immunologic complications for recipients. STUDY DESIGN AND METHODS To evaluate the blood donor selection process, a survey was conducted in 28 blood transfusion centers located in 15 francophone African countries. Data collected included availability of blood products, risk factors for infection identified among blood donor candidates, the processing of the information collected before blood collection, the review process for the medical history of blood donor candidates, and deferral criteria for donor candidates. RESULTS During the year 2009, participating transfusion centers identified 366,924 blood donor candidates. A mean of 13% (range, 0%–36%) of the donor candidates were excluded based solely on their medical status. The main risk factors for blood-borne infections were having multiple sex partners, sexual intercourse with occasional partners, and religious scarification. Most transfusion centers collected this information verbally instead of having a written questionnaire. The topics least addressed were the possible complications relating to the donation, religious scarifications, and history of sickle cell anemia and hemorrhage. Only three centers recorded the temperature of the blood donors. The deferral criteria least reported were sickle cell anemia, piercing, scarification, and tattoo. CONCLUSIONS The medical selection process was not performed systemically and thoroughly enough, given the regional epidemiologic risks. It is essential to identify the risk factors specific to francophone African countries and modify the current medical history questionnaires to develop a more effective and relevant selection process. PMID:22014098

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

    MedlinePlus

    ... Product Assurance Branch Boating Safety Circulars Beacon Alerts Marine Safety Alerts Multimedia PSA's Image Library News Videos ... National Nonprofit Organization Funding Opportunity Application Deadline Announced MARINE SAFETY ALERT ISSUED FOR INFLATABLE LIFE JACKETS MARINE ...

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

    NASA Astrophysics Data System (ADS)

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

    1993-03-01

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

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

    PubMed

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

    2013-01-01

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

  13. Understanding and Evaluating Assurance Cases

    NASA Technical Reports Server (NTRS)

    Rushby, John; Xu, Xidong; Rangarajan, Murali; Weaver, Thomas L.

    2015-01-01

    Assurance cases are a method for providing assurance for a system by giving an argument to justify a claim about the system, based on evidence about its design, development, and tested behavior. In comparison with assurance based on guidelines or standards (which essentially specify only the evidence to be produced), the chief novelty in assurance cases is provision of an explicit argument. In principle, this can allow assurance cases to be more finely tuned to the specific circumstances of the system, and more agile than guidelines in adapting to new techniques and applications. The first part of this report (Sections 1-4) provides an introduction to assurance cases. Although this material should be accessible to all those with an interest in these topics, the examples focus on software for airborne systems, traditionally assured using the DO-178C guidelines and its predecessors. A brief survey of some existing assurance cases is provided in Section 5. The second part (Section 6) considers the criteria, methods, and tools that may be used to evaluate whether an assurance case provides sufficient confidence that a particular system or service is fit for its intended use. An assurance case cannot provide unequivocal "proof" for its claim, so much of the discussion focuses on the interpretation of such less-than-definitive arguments, and on methods to counteract confirmation bias and other fallibilities in human reasoning.

  14. Quality assurance in film radiography

    SciTech Connect

    Van Bellegem, L.; Vaessen, B.

    1993-12-31

    The ISO 9000 standards were originally developed during the 1980`s to provide uniform, worldwide quality assurance requirements. The EC (European Communities) adopted these standards as part of their modular approach to ``conformity assessment`` procedures, for several product categories. This includes the development of standards (specifications) which define what the purchaser wants and what the supplier agrees to provide, as well as quality system registration (certification) which increases confidence in the supplier`s ability to produce consistently. The requirements are typically most rigorous for regulated products that have a major impact on health and safety i.e film radiographic systems. This is the main reason for making available the necessary Q.C. tools in film radiography to comply with Q.A. specifications and guarantee the required consistent performance. These tools can only give satisfying support if they are dedicated, easy to use, precise and cost effective at the user`s level. The main topics for such a Q.A. package are: (1) standard for Film System classification for industrial radiography; (2) film system certification; and (3) standard for control of film processing by means of reference values i.e. pre-exposed film wedges and archiving quality control method.

  15. Software Quality Assurance Audits Guidebooks

    NASA Technical Reports Server (NTRS)

    1990-01-01

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

  16. Allowing blood donation from men who had sex with men more than 5 years ago: a model to evaluate the impact on transfusion safety in Canada.

    PubMed

    Germain, M; Robillard, P; Delage, G; Goldman, M

    2014-05-01

    Canada now allows donations from men who had sex with men (MSM) if their last sexual contact with a man was more than 5 years ago. We modelled the impact of this policy on supply and safety. Approximately 4500 new donors will be added and assuming compliance to the new policy remains unchanged, the worst-case scenario predicts the introduction of one HIV-contaminated unit in the inventory every 1072 years. This change will entail negligible additional HIV risk to recipients. A five-year deferral will also protect recipients against the theoretical concern that MSM may represent a group at higher risk of sexually transmitted, emerging blood borne pathogens.

  17. 16 CFR 1101.33 - Reasonable steps to assure information release is fair in the circumstances.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Reasonable steps to assure information release is fair in the circumstances. 1101.33 Section 1101.33 Commercial Practices CONSUMER PRODUCT SAFETY... of the Acts It Administers § 1101.33 Reasonable steps to assure information release is fair in...

  18. Natriuretic Peptides as Cardiovascular Safety Biomarkers in Rats: Comparison With Blood Pressure, Heart Rate, and Heart Weight.

    PubMed

    Engle, Steven K; Watson, David E

    2016-02-01

    Cardiovascular (CV) toxicity is an important cause of failure during drug development. Blood-based biomarkers can be used to detect CV toxicity during preclinical development and prioritize compounds at lower risk of causing such toxicities. Evidence of myocardial degeneration can be detected by measuring concentrations of biomarkers such as cardiac troponin I and creatine kinase in blood; however, detection of functional changes in the CV system, such as blood pressure, generally requires studies in animals with surgically implanted pressure transducers. This is a significant limitation because sustained changes in blood pressure are often accompanied by changes in heart rate and together can lead to cardiac hypertrophy and myocardial degeneration in animals, and major adverse cardiovascular events (MACE) in humans. Increased concentrations of NPs in blood correlate with higher risk of cardiac mortality, all-cause mortality, and MACE in humans. Their utility as biomarkers of CV function and toxicity in rodents was investigated by exploring the relationships between plasma concentrations of NTproANP and NTproBNP, blood pressure, heart rate, and heart weight in Sprague Dawley rats administered compounds that caused hypotension or hypertension, including nifedipine, fluprostenol, minoxidil, L-NAME, L-thyroxine, or sunitinib for 1-2 weeks. Changes in NTproANP and/or NTproBNP concentrations were inversely correlated with changes in blood pressure. NTproANP and NTproBNP concentrations were inconsistently correlated with relative heart weights. In addition, increased heart rate was associated with increased heart weights. These studies support the use of natriuretic peptides and heart rate to detect changes in blood pressure and cardiac hypertrophy in short-duration rat studies.

  19. Study on the postprandial blood glucose suppression effect of D-psicose in borderline diabetes and the safety of long-term ingestion by normal human subjects.

    PubMed

    Hayashi, Noriko; Iida, Tetsuo; Yamada, Takako; Okuma, Kazuhiro; Takehara, Isao; Yamamoto, Takashi; Yamada, Koji; Tokuda, Masaaki

    2010-01-01

    This clinical study was conducted to investigate the safety and effect of D-psicose on postprandial blood glucose levels in adult men and women, including borderline diabetes patients. A randomized double-blind placebo-controlled crossover experiment of single ingestion was conducted on 26 subjects who consumed zero or 5 g of D-psicose in tea with a standard meal. The blood glucose levels at fasting and 30, 60, 90, and 120 min after the meal were compared. The blood glucose level was significantly lower 30 and 60 min after the meal with D-psicose (p<0.01, p<0.05), and a significant decrease was also shown in the area under the curve (p<0.01). The results suggest that D-psicose had an effect to suppress the postprandial blood glucose elevation mainly in borderline diabetes cases. A randomized double-blind placebo-controlled parallel-group experiment of long-term ingestion was conducted on 17 normal subjects who took 5 g of D-psicose or D-glucose with meals three times a day for 12 continuous weeks. Neither any abnormal effects nor clinical problems caused by the continuous ingestion of D-psicose were found.

  20. Operating and Assurance Program Plan. Revision 4

    SciTech Connect

    Not Available

    1994-07-01

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

  1. Efficacy and Safety of Stroke Volume Variation-Guided Fluid Therapy for Reducing Blood Loss and Transfusion Requirements During Radical Cystectomy: A Randomized Clinical Trial.

    PubMed

    Kong, Yu-Gyeong; Kim, Ji Yoon; Yu, Jihion; Lim, Jinwook; Hwang, Jai-Hyun; Kim, Young-Kug

    2016-05-01

    Radical cystectomy, which is performed to treat muscle-invasive bladder tumors, is among the most difficult urological surgical procedures and puts patients at risk of intraoperative blood loss and transfusion. Fluid management via stroke volume variation (SVV) is associated with reduced intraoperative blood loss. Therefore, we evaluated the efficacy and safety of SVV-guided fluid therapy for reducing blood loss and transfusion requirements in patients undergoing radical cystectomy.This study included 48 patients who underwent radical cystectomy, and these patients were randomly allocated to the control group and maintained at <10% SVV (n = 24) or allocated to the trial group and maintained at 10% to 20% SVV (n = 24). The primary endpoints were comparisons of the amounts of intraoperative blood loss and transfused red blood cells (RBCs) between the control and trial groups during radical cystectomy. Intraoperative blood loss was evaluated through the estimated blood loss and estimated red cell mass loss. The secondary endpoints were comparisons of the postoperative outcomes between groups.A total of 46 patients were included in the final analysis: 23 patients in the control group and 23 patients in the trial group. The SVV values in the trial group were significantly higher than in the control group. Estimated blood loss, estimated red cell mass loss, and RBC transfusion requirements in the trial group were significantly lower than in the control group (734.3 ± 321.5 mL vs 1096.5 ± 623.9 mL, P = 0.019; 274.1 ± 207.8 mL vs 553.1 ± 298.7 mL, P <0.001; 0.5 ± 0.8 units vs 1.9 ± 2.2 units, P = 0.005). There were no significant differences in postoperative outcomes between the two groups.SVV-guided fluid therapy (SVV maintained at 10%-20%) can reduce blood loss and transfusion requirements in patients undergoing radical cystectomy without resulting in adverse outcomes. These findings provide useful information for

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

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  3. Construction quality assurance report

    SciTech Connect

    Roscha, V.

    1994-09-08

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

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

    PubMed Central

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

    2015-01-01

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

  5. Recent Trends in Quality Assurance

    ERIC Educational Resources Information Center

    Amaral, Alberto; Rosa, Maria Joao

    2010-01-01

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

  6. Era of blood component therapy: time for mandatory pre-donation platelet count for maximizing donor safety and optimizing quality of platelets.

    PubMed

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

    2013-12-01

    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 (p<0.001) decrement of donor blood 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 (p<0.001) when donor platelet count 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

  7. Use of ambulatory blood pressure monitoring to compare antihypertensive efficacy and safety of two angiotensin II receptor antagonists, losartan and valsartan. Losartan Trial Investigators.

    PubMed

    Monterroso, V H; Rodriguez Chavez, V; Carbajal, E T; Vogel, D R; Aroca Martinez, G J; Garcia, L H; Cuevas, J H; Lara Teran, J; Hitzenberger, G; Leao Neves, P; Middlemost, S J; Dumortier, T; Bunt, A M; Smith, R D

    2000-01-01

    The efficacy and safety of losartan and valsartan were evaluated in a multicenter, double-blind, randomized trial in patients with mild to moderate essential hypertension. Blood pressure responses to once-daily treatment with either losartan 50 mg (n = 93) or valsartan 80 mg (n = 94) for 6 weeks were assessed through measurements taken in the clinic and by 24-hour ambulatory blood pressure monitoring (ABPM). Both drugs significantly reduced clinic sitting systolic (SiSBP) and diastolic blood pressure (SiDBP) at 2, 4, and 6 weeks. Maximum reductions from baseline in SiSBP and SiDBP on 24-hour ABPM were also significant with the two treatments. The reduction in blood pressure was more consistent across patients in the losartan group, as indicated by a numerically smaller variability in change from baseline on all ABPM measures, which achieved significance at peak (P = .017) and during the day (P = .002). In addition, the numerically larger smoothness index with losartan suggested a more homogeneous antihypertensive effect throughout the 24-hour dosing interval. The antihypertensive response rate was 54% with losartan and 46% with valsartan. Three days after discontinuation of therapy, SiDBP remained below baseline in 73% of losartan and 63% of valsartan patients. Both agents were generally well tolerated. Losartan, but not valsartan, significantly decreased serum uric acid an average 0.4 mg/dL at week 6. In conclusion, once-daily losartan 50 mg and valsartan 80 mg had similar antihypertensive effects in patients with mild to moderate essential hypertension. Losartan produced a more consistent blood pressure-lowering response and significantly lowered uric acid, suggesting potentially meaningful differences between these two A II receptor antagonists.

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

    SciTech Connect

    1986-01-01

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

  9. Quality Assurance [for Persons with Developmental Disabilities].

    ERIC Educational Resources Information Center

    Lakin, Charlie, Ed.; And Others

    1993-01-01

    This newsletter feature issue focuses on quality assurance and innovative efforts to enhance service quality for persons with developmental disabilities. Individual articles include: "Redesigning Quality Assurance" (Clarence J. Sundram); "Quality Assurance, Quality Enhancement" (Charlie Lakin et al.); "Challenging…

  10. NASA Software Assurance's Roles in Research and Technology

    NASA Technical Reports Server (NTRS)

    Wetherholt, Martha

    2010-01-01

    This slide presentation reviews the interactions between the scientist and engineers doing research and technology and the software developers and others who are doing software assurance. There is a discussion of the role of the Safety and Mission Assurance (SMA) in developing software to be used for research and technology, and the importance of this role as the technology moves to the higher levels of the technology readiness levels (TRLs). There is also a call to change the way the development of software is developed.

  11. Hand Safety

    MedlinePlus

    ... Hand Safety Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening Safety Turkey Carving Removing a Ring ... Hand Safety Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening Safety Turkey Carving Removing a Ring ...

  12. Process measurement assurance program

    SciTech Connect

    Pettit, R.B.

    1996-05-01

    This paper describes a new method for determining, improving, and controlling the measurement process errors (or measurement uncertainty) of a measurement system used to monitor product as it is manufactured. The method is called the Process Measurement Assurance Program (PMAP). It integrates metrology early into the product realization process and is a step beyond statistical process control (SPC), which monitors only the product. In this method, a control standard is used to continuously monitor the status of the measurement system. Analysis of the control standard data allow the determination of the measurement error inherent in the product data and allow one to separate the variability in the manufacturing process from variability in the measurement process. These errors can be then associated with either the measurement equipment, variability of the measurement process, operator bias, or local environmental effects. Another goal of PMAP is to determine appropriate re-calibration intervals for the measurement system, which may be significantly longer or shorter than the interval typically assigned by the calibration organization.

  13. New challenges in assuring vaccine quality.

    PubMed Central

    Dellepiane, N.; Griffiths, E.; Milstien, J. B.

    2000-01-01

    In the past, quality control of vaccines depended on use of a variety of testing methods to ensure that the products were safe and potent. These methods were developed for vaccines whose safety and efficacy were based on several years worth of data. However, as vaccine production technologies have developed, so have the testing technologies. Tests are now able to detect potential hazards with a sensitivity not possible a few years ago, and an increasing array of physicochemical methods allows a much better characterization of the product. In addition to sophisticated tests, vaccine regulation entails a number of other procedures to ensure safety. These include characterization of starting materials by supplier audits, cell banking, seed lot systems, compliance with the principles of good manufacturing practices, independent release of vaccines on a lot-by-lot basis by national regulatory authorities, and enhanced pre- and post-marketing surveillance for possible adverse events following immunization. These procedures help assure vaccine efficacy and safety, and some examples are given in this article. However, some contaminants of vaccines that can be detected by newer assays raise theoretical safety concerns but their presence may be less hazardous than not giving the vaccines. Thus risk-benefit decisions must be well informed and based on scientific evidence. PMID:10743279

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

    PubMed Central

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

    2016-01-01

    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

  15. BUILDING "BRIDGES" WITH QUALITY ASSURANCE

    EPA Science Inventory

    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...

  16. The NOνA Module Factory Quality Assurance System

    NASA Astrophysics Data System (ADS)

    Smith, Alex; the NOνA Collaboration

    The NOνA experiment will measure neutrino oscillations using a long-baseline beam, a ∼220-ton near detector and a ∼14-kiloton far detector. Production of ∼12500 modules to build these detectors is an industrial scale operation requiring careful quality assurance to meet the stringent technical specifications. Unlike a typical industrial operation, this project will use primarily a part time labor force of ∼200 University of Minnesota undergraduate students managed by a small team of full time employees. The quality assurance system is involved in nearly every aspect of the production: assembly, scheduling, training, payroll, materials, machine maintenance, test data, and safety compliance. The quality assurance data collected during the assembly process allows us to quickly identify and correct any problems that arise.

  17. Risk-based requirements management framework with applications to assurance cases

    NASA Astrophysics Data System (ADS)

    Feng, D.; Eyster, C.

    The current regulatory approach for assuring device safety primarily focuses on compliance with prescriptive safety regulations and relevant safety standards. This approach, however, does not always lead to a safe system design even though safety regulations and standards have been met. In the medical device industry, several high profile recalls involving infusion pumps have prompted the regulatory agency to reconsider how device safety should be managed, reviewed and approved. An assurance case has been cited as a promising tool to address this growing concern. Assurance cases have been used in safety-critical systems for some time. Most assurance cases, if not all, in literature today are developed in an ad hoc fashion, independent from risk management and requirement development. An assurance case is a resource-intensive endeavor that requires additional effort and documentation from equipment manufacturers. Without a well-organized requirements infrastructure in place, such “ additional effort” can be substantial, to the point where the cost of adoption outweighs the benefit of adoption. In this paper, the authors present a Risk-Based Requirements and Assurance Management (RBRAM) methodology. The RBRAM is an elaborate framework that combines Risk-Based Requirements Management (RBRM) with assurance case methods. Such an integrated framework can help manufacturers leverage an existing risk management to present a comprehensive assurance case with minimal additional effort while providing a supplementary means to reexamine the integrity of the system design in terms of the mission objective. Although the example used is from the medical industry, the authors believe that the RBRAM methodology underlines the fundamental principle of risk management, and offers a simple, yet effective framework applicable to aerospace industry, perhaps, to any industry.

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

    PubMed

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

    2015-02-01

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

  19. First Indian study to establish safety of immediate-spin crossmatch for red blood cell transfusion in antibody screen-negative recipients

    PubMed Central

    Tiwari, Aseem Kumar; Aggarwal, Geet; Dara, Ravi C.; Arora, Dinesh; Gupta, Gautam Kumar; Raina, Vimarsh

    2017-01-01

    BACKGROUND AND OBJECTIVES: The US Food and Drug Administration and American Association of Blood Banks approved the type and screen approach in 1980s, long after antibody screen (AS) was introduced in 1950s. The present study omits conventional anti-human globulin (AHG) crossmatch and replaces it with immediate-spin (IS) crossmatch as part of pretransfusion testing in AS-negative patients to study the safety and effectiveness of IS crossmatch in recipients. MATERIALS AND METHODS: This prospective longitudinal study was conducted on over 5000 red cell units transfused to AS-negative patients admitted to the hospital. Pretransfusion testing comprised blood grouping and AS followed by IS crossmatch, at the time of issue of red cell unit. The patients were transfused IS compatible red cell units. AHG crossmatch was performed posttransfusion for all red cell units. Any incompatible AHG crossmatch was followed up as suspected transfusion reaction. RESULTS: A total of 5023 red cell units were transfused to 2402 patients with negative AS. 99.7% IS compatible red cell units were also compatible on posttransfusion AHG crossmatch. Anti-P1 alloantibody was identified in one patient who was transfused two IS crossmatch compatible units but later both units were incompatible on AHG crossmatch. There was no clinical or serological sign of hemolysis in the patient. CONCLUSION: In AS-negative patients, IS crossmatch is as safe as conventional AHG crossmatch and can, therefore, replace conventional AHG crossmatch protocol. PMID:28316439

  20. 75 FR 63893 - Safety Advisory 2010-03

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-18

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

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

    PubMed

    Murphy, E L

    2016-02-01

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

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

    PubMed

    Cuny, E; Carpenter, W M

    1998-04-01

    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.

  3. 10 CFR 71.37 - Quality assurance.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 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...

  4. 10 CFR 71.37 - Quality assurance.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 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...

  5. 10 CFR 71.37 - Quality assurance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 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...

  6. 40 CFR 51.363 - Quality assurance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 2 2013-07-01 2013-07-01 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...

  7. 10 CFR 71.37 - Quality assurance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  8. 10 CFR 71.37 - Quality assurance.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 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...

  9. 40 CFR 51.363 - Quality assurance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 2 2011-07-01 2011-07-01 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...

  10. Thoughts on Internal and External Quality Assurance

    ERIC Educational Resources Information Center

    Zhang, Jianxin

    2012-01-01

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

  11. Risk of human immunodeficiency virus (HIV) transmission by blood transfusions before the implementation of HIV-1 antibody screening. The Transfusion Safety Study Group.

    PubMed

    Busch, M P; Young, M J; Samson, S M; Mosley, J W; Ward, J W; Perkins, H A

    1991-01-01

    Little information is available regarding the risk of human immunodeficiency virus type 1 (HIV-1) infection for patients transfused before routine anti-HIV-1 screening of blood donors was instituted in March 1985. A model was developed for estimating both the proportion and the number of transfusion recipients in the San Francisco Bay area who were infected by HIV-1 during each of the 7 years preceding routine donor screening for anti-HIV-1. The model is based on analysis of 1) donation histories of HIV-1-infected donors identified at the regional blood center; 2) HIV-1 seroprevalence estimates for homosexual and bisexual men in San Francisco; and 3) HIV-1 infection and survival rates for recipients traced by the Transfusion Safety Study and Irwin Memorial Blood Centers' Look Back Program. The incidence of transfusion-associated HIV-1 infection is estimated to have risen rapidly from the first occurrence in 1978 to a peak in late 1982 of approximately 1.1 percent per transfused unit. The decrease after 1982 coincided with the implementation of high-risk donor deferral measures. It is estimated that, overall, approximately 2135 transfusion recipients were infected with HIV-1 in the San Francisco region alone. This number suggests a higher prevalence of transfusion-associated HIV-1 infection than has been generally recognized and indicates the need for continued tracing of potentially exposed recipients. The data also strongly support the effectiveness of early donor education and self-exclusion measures and emphasize the importance of continued research and development in this area.

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

    SciTech Connect

    Fishler, B

    2011-03-18

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

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

    USGS Publications Warehouse

    Dodge, Kent A.; Lambing, John H.

    2006-01-01

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

  14. Assurance in Agent-Based Systems

    SciTech Connect

    Gilliom, Laura R.; Goldsmith, Steven Y.

    1999-05-10

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

  15. Querying Safety Cases

    NASA Technical Reports Server (NTRS)

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

    2014-01-01

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

  16. Quality assurance from a manufacturer's standpoint

    NASA Astrophysics Data System (ADS)

    Anderson, William J.

    1991-05-01

    The efforts of a manufacturer in the area of component procurement acceptance testing are very visible, while the quality assurance work that goes on during the design and manufacture of medical imaging equipment is frequently not so apparent. Many steps in the design and production of imaging devices are carefully designed to promote not only quality of the devices when initially installed, but also the ability to maintain the device''s quality over a period of time. Customer requirements for aesthetics, performance, safety and regulatory compliance must be considered. Software, which represents over 70 of the design engineering of modern products, presents a special challenge since the quality of software cannot be tested and must be designed in. Specific hardware elements such as monitor phosphor color and uniformity deserve extra consideration. A design that allows quick diagnosis and replacement of failed components is also important.

  17. Blood Glucose Monitoring Devices

    MedlinePlus

    ... the Bar for Blood Glucose Meter Performance Recalls & Alerts Shasta Technologies GenStrip Blood Glucose Test Strips May ... Latest Recalls Report an Adverse Event MedWatch Safety Alerts News Releases Consumer Updates About FDA Contact FDA ...

  18. 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.

    PubMed

    Seghatchian, Jerard; Amiral, Jean

    2016-08-01

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

  19. Hierarchical Safety Cases

    NASA Technical Reports Server (NTRS)

    Denney, Ewen W.; Whiteside, Iain J.

    2012-01-01

    We introduce hierarchical safety cases (or hicases) as a technique to overcome some of the difficulties that arise creating and maintaining industrial-size safety cases. Our approach extends the existing Goal Structuring Notation with abstraction structures, which allow the safety case to be viewed at different levels of detail. We motivate hicases and give a mathematical account of them as well as an intuition, relating them to other related concepts. We give a second definition which corresponds closely to our implementation of hicases in the AdvoCATE Assurance Case Editor and prove the correspondence between the two. Finally, we suggest areas of future enhancement, both theoretically and practically.

  20. Energy Surety Microgrids (trademark) Supporting Renewable Technologies and Energy Assurance

    DTIC Science & Technology

    2010-11-30

    Small combustion and µ-turbines Fuel cells IC engines Small hydro and wind Solar electric and solar thermal Energy storage (batteries, flywheels...assurance (safety, security, reliability) • Facilitates integration of renewable resources and DG • Offers opportunities for CHP /Tri-power – greater...400 KW 600 KW B B B C NG ES 3xx CHP ES C Static switch and controls to isolate Microgrid from utility during outages Use breakers

  1. Modernization of software quality assurance

    NASA Technical Reports Server (NTRS)

    Bhaumik, Gokul

    1988-01-01

    The customers satisfaction depends not only on functional performance, it also depends on the quality characteristics of the software products. An examination of this quality aspect of software products will provide a clear, well defined framework for quality assurance functions, which improve the life-cycle activities of software development. Software developers must be aware of the following aspects which have been expressed by many quality experts: quality cannot be added on; the level of quality built into a program is a function of the quality attributes employed during the development process; and finally, quality must be managed. These concepts have guided our development of the following definition for a Software Quality Assurance function: Software Quality Assurance is a formal, planned approach of actions designed to evaluate the degree of an identifiable set of quality attributes present in all software systems and their products. This paper is an explanation of how this definition was developed and how it is used.

  2. Software safety - A user's practical perspective

    NASA Technical Reports Server (NTRS)

    Dunn, William R.; Corliss, Lloyd D.

    1990-01-01

    Software safety assurance philosophy and practices at the NASA Ames are discussed. It is shown that, to be safe, software must be error-free. Software developments on two digital flight control systems and two ground facility systems are examined, including the overall system and software organization and function, the software-safety issues, and their resolution. The effectiveness of safety assurance methods is discussed, including conventional life-cycle practices, verification and validation testing, software safety analysis, and formal design methods. It is concluded (1) that a practical software safety technology does not yet exist, (2) that it is unlikely that a set of general-purpose analytical techniques can be developed for proving that software is safe, and (3) that successful software safety-assurance practices will have to take into account the detailed design processes employed and show that the software will execute correctly under all possible conditions.

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

    PubMed Central

    Downs, Matthew E.; Buch, Amanda; Sierra, Carlos; Karakatsani, Maria Eleni; Chen, Shangshang; Konofagou, Elisa E.; Ferrera, Vincent P.

    2015-01-01

    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 (500kHz, 200–400 kPa, 4–5μm 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. PMID:25945493

  4. 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

    SciTech Connect

    Chan, M; Leung, R; Wong, M; Lee, V; Law, G; Lee, K; Tung, S; Blanck, O

    2015-06-15

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

  5. Multiple sessions of liposomal doxorubicin delivery via focused ultrasound mediated blood-brain barrier disruption: a safety study

    PubMed Central

    Aryal, Muna; Vykhodtseva, Natalia; Zhang, Yong-Zhi; McDannold, Nathan

    2015-01-01

    Transcranial MRI-guided focused ultrasound is a rapidly advancing method for delivering therapeutic and imaging agents to the brain. It has the ability to facilitate the passage of therapeutics from the vasculature to the brain parenchyma, which is normally protected by the blood-brain barrier (BBB). The method’s main advantages are that it is both targeted and noninvasive, and that it can be easily repeated. Studies have shown that liposomal doxorubicin (Lipo-DOX), a chemotherapy agent with promise for tumors in the central nervous system, can be delivered into the brain across BBB. However, prior studies have suggested that doxorubicin can be significantly neurotoxic, even at small concentrations. Here, we studied whether multiple sessions of Lipo-DOX administered after FUS-induced BBB disruption (FUS-BBBD) induces severe adverse events in the normal brain tissues. First, we used fluorometry to measure the doxorubicin concentrations in the brain after FUS-BBBD to ensure that a clinically relevant doxorubicin concentration was achieved in the brain. Next, we performed three weekly sessions with FUS-BBBD ± Lipo-DOX administration. Five to twelve targets were sonicated each week, following a schedule described previously in a survival study in glioma-bearing rats (Aryal et al., 2013). Five rats received three weekly sessions where i.v. injected Lipo-DOX was combined with FUS-BBBD; an additional four rats received FUS-BBBD only. Animals were euthanized 70 days from the first session and brains were examined in histology. We found that clinically-relevant concentrations of doxorubicin (4.8 ± 0.5 µg/g) were delivered to the brain with the sonication parameters (0.69 MHz; 0.55–0.81 MPa; 10 ms bursts; 1 Hz PRF; 60s duration), microbubble concentration (Definity, 10 µl/kg), and the administered Lipo-DOX dose (5.67 mg/kg) used. The resulting concentration of Lipo-DOX was reduced by 32% when it was injected 10 minutes after the last sonication compared to cases

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

    PubMed

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

    2014-01-01

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

  7. Quality Assurance 1992-2012

    ERIC Educational Resources Information Center

    Brown, Roger

    2012-01-01

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

  8. Quality Assurance Program. QAP Workbook.

    ERIC Educational Resources Information Center

    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…

  9. Metrology: Measurement Assurance Program Guidelines

    NASA Technical Reports Server (NTRS)

    Eicke, W. G.; Riley, J. P.; Riley, K. J.

    1995-01-01

    The 5300.4 series of NASA Handbooks for Reliability and Quality Assurance Programs have provisions for the establishment and utilization of a documented metrology system to control measurement processes and to provide objective evidence of quality conformance. The intent of these provisions is to assure consistency and conformance to specifications and tolerances of equipment, systems, materials, and processes procured and/or used by NASA, its international partners, contractors, subcontractors, and suppliers. This Measurement Assurance Program (MAP) guideline has the specific objectives to: (1) ensure the quality of measurements made within NASA programs; (2) establish realistic measurement process uncertainties; (3) maintain continuous control over the measurement processes; and (4) ensure measurement compatibility among NASA facilities. The publication addresses MAP methods as applied within and among NASA installations and serves as a guide to: control measurement processes at the local level (one facility); conduct measurement assurance programs in which a number of field installations are joint participants; and conduct measurement integrity (round robin) experiments in which a number of field installations participate to assess the overall quality of particular measurement processes at a point in time.

  10. Defense Healthcare Information Assurance Program

    DTIC Science & Technology

    2001-06-01

    assurance. RADIUS Prototype I • lementation As depicted in Figure 5, the DHIAP Team used ISE results ( Emerging TechnologyI to identify specific situations...VA, facility size/purpose (from outpatient clinic to regional medical center), and facility type (fixed, mobile , deployed). TATRC called for

  11. Mission Assurance: Issues and Challenges

    DTIC Science & Technology

    2010-07-15

    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. Legacy Management CERCLA Sites. Quality Assurance Project Plan

    SciTech Connect

    Riddle, Donna L.

    2007-05-03

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

  13. 49 CFR 385.311 - What will the safety audit consist of?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  14. Waste Management Quality Assurance Plan

    SciTech Connect

    Not Available

    1993-11-30

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

  15. DoD Veterinary Service Activity Role in DoD Food Safety.

    DTIC Science & Technology

    1998-01-01

    medical research and development; zoonotic disease prevention and control; and food safety and quality assurance. The latter mission is not all encompassing...within DoD. This paper reviews the division of responsibilities, within DoD, for food safety and quality assurance. The complexity of the division...and the problem it causes joint operations planners are explored. A proposal for integrating overall strategic responsibility for food safety and quality assurance into the DoD Veterinary Service Activity is developed.

  16. Quality assurance for environmental analytical chemistry: 1980

    SciTech Connect

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

    1981-09-01

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

  17. Implementing Financial Assurance for Mitigation Project Success

    EPA Pesticide Factsheets

    The Institute for Water Resources (IWR) prepared this white paper on financial assurance for mitigation project success to provide a reference resource for Corps district staff involved with establishing and overseeing financial assurances.

  18. Process chemistry {ampersand} statistics quality assurance plan

    SciTech Connect

    Meznarich, H.K.

    1996-08-01

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

  19. Maintaining plant safety margins

    SciTech Connect

    Bergeron, P.A.

    1989-01-01

    The Final Safety Analysis Report Forms the basis of demonstrating that the plant can operate safely and meet all applicable acceptance criteria. In order to assure that this continues through each operating cycle, the safety analysis is reexamined for each reload core. Operating limits are set for each reload core to assure that safety limits and applicable acceptance criteria are not exceeded for postulated events within the design basis. These operating limits form the basis for plant operation, providing barriers on various measurable parameters. The barriers are refereed to as limiting conditions for operation (LCO). The operating limits, being influenced by many factors, can change significantly from cycle to cycle. In order to be successful in demonstrating safe operation for each reload core (with adequate operating margin), it is necessary to continue to focus on ways to maintain/improve existing safety margins. Existing safety margins are a function of the plant type (boiling water reactor/pressurized water reactor (BWR/PWR)), nuclear system supply (NSSS) vendor, operating license date, core design features, plant design features, licensing history, and analytical methods used in the safety analysis. This paper summarizes the experience at Yankee Atomic Electric Company (YAEC) in its efforts to provide adequate operating margin for the plants that it supports.

  20. 40 CFR 30.54 - Quality assurance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 1 2011-07-01 2011-07-01 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...

  1. 40 CFR 194.22 - Quality assurance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 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...

  2. 40 CFR 194.22 - Quality assurance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 25 2011-07-01 2011-07-01 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...

  3. 40 CFR 31.45 - Quality assurance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 1 2014-07-01 2014-07-01 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,...

  4. 40 CFR 31.45 - Quality assurance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 1 2012-07-01 2012-07-01 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,...

  5. 40 CFR 30.54 - Quality assurance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 1 2013-07-01 2013-07-01 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...

  6. 40 CFR 31.45 - Quality assurance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 1 2013-07-01 2013-07-01 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,...

  7. 40 CFR 194.22 - Quality assurance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 26 2012-07-01 2011-07-01 true 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...

  8. 40 CFR 30.54 - Quality assurance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  9. 40 CFR 30.54 - Quality assurance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 1 2012-07-01 2012-07-01 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...

  10. 40 CFR 194.22 - Quality assurance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 25 2014-07-01 2014-07-01 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...

  11. 40 CFR 30.54 - Quality assurance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 1 2014-07-01 2014-07-01 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...

  12. 40 CFR 194.22 - Quality assurance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 26 2013-07-01 2013-07-01 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...

  13. 50 CFR 600.240 - Security assurances.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 50 Wildlife and Fisheries 10 2011-10-01 2011-10-01 false Security assurances. 600.240 Section 600... ADMINISTRATION, DEPARTMENT OF COMMERCE MAGNUSON-STEVENS ACT PROVISIONS Council Membership § 600.240 Security assurances. (a) DOC Office of Security will issue security assurances to Council members following...

  14. 50 CFR 600.240 - Security assurances.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 50 Wildlife and Fisheries 12 2012-10-01 2012-10-01 false Security assurances. 600.240 Section 600... ADMINISTRATION, DEPARTMENT OF COMMERCE MAGNUSON-STEVENS ACT PROVISIONS Council Membership § 600.240 Security assurances. (a) DOC Office of Security will issue security assurances to Council members following...

  15. 42 CFR 441.352 - State assurances.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false State assurances. 441.352 Section 441.352 Public... assurances. Unless the Medicaid agency provides the following satisfactory assurances to CMS, CMS will not... expended for home and community-based services. The State must provide for an independent audit f...

  16. 42 CFR 441.302 - State assurances.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false State assurances. 441.302 Section 441.302 Public... Community-Based Services: Waiver Requirements § 441.302 State assurances. Unless the Medicaid agency provides the following satisfactory assurances to CMS, CMS will not grant a waiver under this subpart...

  17. Solar consumer assurance network briefing book

    SciTech Connect

    Connor, Lynda

    1980-06-01

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

  18. [Food safety of GMOs].

    PubMed

    Joudrier, P

    2009-01-01

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

  19. Requirement Assurance: A Verification Process

    NASA Technical Reports Server (NTRS)

    Alexander, Michael G.

    2011-01-01

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

  20. Assuring Life in Composite Systems

    NASA Technical Reports Server (NTRS)

    Chamis, Christos c.

    2008-01-01

    A computational simulation method is presented to assure life in composite systems by using dynamic buckling of smart composite shells as an example. The combined use of composite mechanics, finite element computer codes, and probabilistic analysis enable the effective assessment of the dynamic buckling load of smart composite shells. A universal plot is generated to estimate the dynamic buckling load of composite shells at various load rates and probabilities. The shell structure is also evaluated with smart fibers embedded in the plies right below the outer plies. The results show that, on the average, the use of smart fibers improved the shell buckling resistance by about 9% at different probabilities and delayed the buckling occurrence time. The probabilistic sensitivities results indicate that uncertainties in the fiber volume ratio and ply thickness have major effects on the buckling load. The uncertainties in the electric field strength and smart material volume fraction have moderate effects and thereby in the assured life of the shell.

  1. 48 CFR 246.470 - Government contract quality assurance actions.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  2. Assurance Cases for Medical Devices

    DTIC Science & Technology

    2011-04-28

    SEI’s  Research,  Technology,  and  System   Solu2ons  program.  With  his  colleague  John   Goodenough ,  Weinstock...contact The SEI and Medical Devices *Charles B. Weinstock and John B. Goodenough , Towards an Assurance Case Practice for Medical Devices, CMU/SEI-2009-TN

  3. Consistency and proportionality in policy decision-making in blood safety: the case for an all-apheresis platelet supply in Germany.

    PubMed

    Vamvakas, E C; Hitzler, W E

    2013-01-01

    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.

  4. Quality Assurance for Clinical Trials

    PubMed Central

    Ibbott, Geoffrey S.; Haworth, Annette; Followill, David S.

    2013-01-01

    Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial, the cooperative group prepares a protocol to define the goals of the trial, the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center (RPC) is one of several quality assurance (QA) offices that is charged with assuring that participating institutions deliver doses that are clinically consistent and comparable. The RPC does this by conducting a variety of independent audits and credentialing processes. The RPC has compiled data showing that credentialing can help institutions comply with the requirements of a cooperative group clinical protocol. Phantom irradiations have been demonstrated to exercise an institution’s procedures for planning and delivering advanced external beam techniques (1–3). Similarly, RPC data indicate that a rapid review of patient treatment records or planning procedures can improve compliance with clinical trials (4). The experiences of the RPC are presented as examples of the contributions that a national clinical trials QA center can make to cooperative group trials. These experiences illustrate the critical need for comprehensive QA to assure that clinical trials are successful and cost-effective. The RPC is supported by grants CA 10953 and CA 81647 from the National Cancer Institute, NIH, DHHS. PMID:24392352

  5. Quality assurance in forensic pathology.

    PubMed

    Ong, Beng Beng; Milne, Nathan

    2009-06-01

    One of the requirements for proper running of a pathology laboratory is implementation of a quality assurance programme. Forensic pathology is not exempted, especially so when cases are increasing in complexity. It is not difficult to introduce a quality assurance programme even in a small forensic centre. Among the steps that can be implemented including introduction of a set of minimal standards in performance of the autopsy, timeliness and report writing, a vigorous peer review process either internally or externally and participation in external quality programmes. Proper documentation of the post-mortem process (photography, slides and blocks and various imaging modalities) is to be encouraged. There should be limits set on workload of pathologists as overburden is known to lower standards. A pleasant work environment is also essential. Personal continuous medical education should be made mandatory. Introduction of a quality assurance programme will not only improve standards but minimise possible negligence. The post-mortem reports will be seen to carry more weight in court.

  6. Assuring Ground-Based Detect and Avoid for UAS Operations

    NASA Technical Reports Server (NTRS)

    Denney, Ewen W.; Pai, Ganeshmadhav Jagadeesh; Berthold, Randall; Fladeland, Matthew; Storms, Bruce; Sumich, Mark

    2014-01-01

    One of the goals of the Marginal Ice Zones Observations and Processes Experiment (MIZOPEX) NASA Earth science mission was to show the operational capabilities of Unmanned Aircraft Systems (UAS) when deployed on challenging missions, in difficult environments. Given the extreme conditions of the Arctic environment where MIZOPEX measurements were required, the mission opted to use a radar to provide a ground-based detect-and-avoid (GBDAA) capability as an alternate means of compliance (AMOC) with the see-and-avoid federal aviation regulation. This paper describes how GBDAA safety assurance was provided by interpreting and applying the guidelines in the national policy for UAS operational approval. In particular, we describe how we formulated the appropriate safety goals, defined the processes and procedures for system safety, identified and assembled the relevant safety verification evidence, and created an operational safety case in compliance with Federal Aviation Administration (FAA) requirements. To the best of our knowledge, the safety case, which was ultimately approved by the FAA, is the first successful example of non-military UAS operations using GBDAA in the U.S. National Airspace System (NAS), and, therefore, the first nonmilitary application of the safety case concept in this context.

  7. European perspectives of food safety.

    PubMed

    Bánáti, Diána

    2014-08-01

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

  8. Program Environmental Assurance: Shuttle Environmental Assurance and the Future

    NASA Technical Reports Server (NTRS)

    Glover, Steve E.

    2008-01-01

    Material availability continues to be impacted by domestic and international environmental health and safety (EH&S) regulations, industrial pollution prevention goals and related vendor economics. SEA is an integrated team that works to identify, communicate and address safety and environmentally driven materials obsolescence issues and pollution prevention opportunities.

  9. Quality Interaction Between Mission Assurance and Project Team Members

    NASA Technical Reports Server (NTRS)

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

    2006-01-01

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

  10. Development of Security Software: A High Assurance Methodology

    NASA Astrophysics Data System (ADS)

    Hardin, David; Hiratzka, T. Douglas; Johnson, D. Randolph; Wagner, Lucas; Whalen, Michael

    This paper reports on a project to exercise, evaluate and enhance a methodology for developing high assurance software for an embedded system controller. In this approach, researchers at the National Security Agency capture system requirements precisely and unambiguously through functional specifications in Z. Rockwell Collins then implements these requirements using an integrated, model-based software development approach. The development effort is supported by a tool chain that provides automated code generation and support for formal verification. The specific system is a prototype high speed encryption system, although the controller could be adapted for use in a variety of critical systems in which very high assurance of correctness, reliability, and security or safety properties is essential.

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

    SciTech Connect

    Not Available

    1994-09-01

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

  12. Quality assurance methodology and applications to abdominal imaging PQI.

    PubMed

    Paushter, David M; Thomas, Stephen

    2016-03-01

    Quality assurance has increasingly become an integral part of medicine, with tandem goals of increasing patient safety and procedural quality, improving efficiency, lowering cost, and ultimately improving patient outcomes. This article reviews quality assurance methodology, ranging from the PDSA cycle to the application of lean techniques, aimed at operational efficiency, to continually evaluate and revise the health care environment. Alignment of goals for practices, hospitals, and healthcare organizations is critical, requiring clear objectives, adequate resources, and transparent reporting. In addition, there is a significant role played by regulatory bodies and oversight organizations in determining external benchmarks of quality, practice, and individual certification and reimbursement. Finally, practical application of quality principles to practice improvement projects in abdominal imaging will be presented.

  13. Quality interaction between mission assurance and project team members

    NASA Astrophysics Data System (ADS)

    Kwong-Fu, Helenann; Wilson, Robert K.

    2006-06-01

    Mission Assurance's independent assessments started during the SPITZER development cycle and continued through post-launch operations. During the operations phase, the health and safety of the observatory is of utmost importance. Therefore, Mission Assurance must ensure requirements compliance and focus on the process improvements required across the operational systems, including new/modified products, tools, and procedures. To avoid problem reoccurrences, an interactive model involving three areas was deployed: Team Member Interaction, Root Cause Analysis Practices, and Risk Assessment. In applying this model, a metric-based measurement process was found to have the most significant benefit. Considering a combination of root cause analysis and risk approaches allows project engineers to the ability to prioritize and quantify their corrective actions based on a well-defined set of root cause definitions (i.e., closure criteria for problem reports), success criteria, and risk rating definitions.

  14. Manned space flight nuclear system safety. Volume 6: Space base nuclear system safety plan

    NASA Technical Reports Server (NTRS)

    1972-01-01

    A qualitative identification of the steps required to assure the incorporation of radiological system safety principles and objectives into all phases of a manned space base program are presented. Specific areas of emphasis include: (1) radiological program management, (2) nuclear system safety plan implementation, (3) impact on program, and (4) summary of the key operation and design guidelines and requirements. The plan clearly indicates the necessity of considering and implementing radiological system safety recommendations as early as possible in the development cycle to assure maximum safety and minimize the impact on design and mission plans.

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

    NASA Technical Reports Server (NTRS)

    Fitz, Rhonda

    2016-01-01

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

  16. Aerospace Safety Advisory Panel

    NASA Astrophysics Data System (ADS)

    1993-03-01

    The Aerospace Safety Advisory Panel (ASAP) provided oversight on the safety aspects of many NASA programs. In addition, ASAP undertook three special studies. At the request of the Administrator, the panel assessed the requirements for an assured crew return vehicle (ACRV) for the space station and reviewed the organization of the safety and mission quality function within NASA. At the behest of Congress, the panel formed an independent, ad hoc working group to examine the safety and reliability of the space shuttle main engine. Section 2 presents findings and recommendations. Section 3 consists of information in support of these findings and recommendations. Appendices A, B, C, and D, respectively, cover the panel membership, the NASA response to the findings and recommendations in the March 1992 report, a chronology of the panel's activities during the reporting period, and the entire ACRV study report.

  17. The Hermes safety strategy

    NASA Astrophysics Data System (ADS)

    Rosso, R.

    The Hermes space vehicle currently in project for the European Space Agency will open the road to European autonomous manned space missions at the beginning of the 21st century. The safety objectives are very ambitious and will require the implementation of a comprehensive safety assurance program, aimed at reducing the risks to an acceptable level. The risk acceptance is based on identification, ranking and minimization of Critical Items including all potential departures from the safety requirements. Prime contractors shall prepare a Critical Item List for their elements, and submit it to the Hermes Program Directorate for review; approval of the residual open critical items shall be obtained before launch. An independent committee (HESAC) has been set up by the ESA and the French National Space Center (CNES) Directors General to assess the adequacy of the Safety Control Program.

  18. Organizational Culture and Safety

    NASA Technical Reports Server (NTRS)

    Adams, Catherine A.

    2003-01-01

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

  19. Aerospace Safety Advisory Panel

    NASA Technical Reports Server (NTRS)

    1993-01-01

    The Aerospace Safety Advisory Panel (ASAP) provided oversight on the safety aspects of many NASA programs. In addition, ASAP undertook three special studies. At the request of the Administrator, the panel assessed the requirements for an assured crew return vehicle (ACRV) for the space station and reviewed the organization of the safety and mission quality function within NASA. At the behest of Congress, the panel formed an independent, ad hoc working group to examine the safety and reliability of the space shuttle main engine. Section 2 presents findings and recommendations. Section 3 consists of information in support of these findings and recommendations. Appendices A, B, C, and D, respectively, cover the panel membership, the NASA response to the findings and recommendations in the March 1992 report, a chronology of the panel's activities during the reporting period, and the entire ACRV study report.

  20. Nuclear safety

    NASA Technical Reports Server (NTRS)

    Buden, D.

    1991-01-01

    Topics dealing with nuclear safety are addressed which include the following: general safety requirements; safety design requirements; terrestrial safety; SP-100 Flight System key safety requirements; potential mission accidents and hazards; key safety features; ground operations; launch operations; flight operations; disposal; safety concerns; licensing; the nuclear engine for rocket vehicle application (NERVA) design philosophy; the NERVA flight safety program; and the NERVA safety plan.

  1. Bug repellent safety

    MedlinePlus

    ... gone. Alternative Names Insect repellent safety Images Bee sting References Fradin MS, Carroll SP. Protection from blood- ... team. Related MedlinePlus Health Topics Insect Bites and Stings Browse the Encyclopedia A.D.A.M., Inc. ...

  2. Pilot education and safety awareness programs

    NASA Technical Reports Server (NTRS)

    Shearer, M.; Reynard, W. D.

    1984-01-01

    Guidelines necessary for the implementation of safety awareness programs for commuter airlines are discussed. A safety office can be viewed as fulfilling either an education and training function or a quality assurance function. Issues such as management structure, motivation, and cost limitations are discussed.

  3. Nuclear Powerplant Safety: Design and Planning.

    ERIC Educational Resources Information Center

    Department of Energy, Washington, DC. Nuclear Energy Office.

    The most important concern in the design, construction and operation of nuclear powerplants is safety. Nuclear power is one of the major contributors to the nation's supply of electricity; therefore, it is important to assure its safe use. Each different type of powerplant has special design features and systems to protect health and safety. One…

  4. 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.

    PubMed

    2015-05-27

    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.

  5. Space Launch System (SLS) Safety, Mission Assurance, and Risk Mitigation

    NASA Technical Reports Server (NTRS)

    May, Todd

    2013-01-01

    SLS Driving Objectives: I. Safe: a) Human-rated to provide safe and reliable systems for human missions. b) Protecting the public, NASA workforce, high-value equipment and property, and the environment from potential harm. II. Affordable: a) Maximum use of common elements and existing assets, infrastructure, and workforce. b) Constrained budget environment. c) Competitive opportunities for affordability on-ramps. III. Sustainable: a) Initial capability: 70 metric tons (t), 2017-2021. 1) Serves as primary transportation for Orion and exploration missions. 2) Provides back-up capability for crew/cargo to ISS. b) Evolved capability: 105 t and 130 t, post-2021. 1) Offers large volume for science missions and payloads. 2) Modular and flexible, right-sized for mission requirements.

  6. Assuring the Safety of Chemicals through Improved Exposure Science

    EPA Science Inventory

    Thousands of chemicals are currently in commercial use and hundreds more are introduced each year. Of these, only a small fraction has been assessed adequately for potential risks. Existing chemical testing and exposure measurement protocols are expensive and time consuming. Fu...

  7. Radiation Safety and Quality Assurance in North American Dental Schools.

    ERIC Educational Resources Information Center

    Farman, Allan G.; Hines, Vickie G.

    1986-01-01

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

  8. Radiation safety and quality assurance in North American dental schools

    SciTech Connect

    Farman, A.G.; Hines, V.G.

    1986-06-01

    A survey of North American dental schools revealed that processing quality control and routine maintenance checks on x-ray generators are, in most instances, being carried out in a timely manner. Available methods for reducing patient exposure to ionizing radiation are, however, not being fully implemented. Furthermore, in some instances, dental students are still being exposed to x-rays primarily for teaching purposes.

  9. JSC Safety and Mission Assurance Data Analysis Overview

    NASA Technical Reports Server (NTRS)

    Roelant, Henk

    2010-01-01

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

  10. Product Assurance for Spaceflight Hardware

    NASA Technical Reports Server (NTRS)

    Monroe, Mike

    1995-01-01

    This report contains information about the tasks I have completed and the valuable experience I have gained at NASA. The report is divided into two different sections followed by a program summary sheet. The first section describes the two reports I have completed for the Office of Mission Assurance (OMA). I describe the approach and the resources and facilities used to complete each report. The second section describes my experience working in the Receipt Inspection/Quality Assurance Lab (RI/QA). The first report described is a Product Assurance Plan for the Gas Permeable Polymer Materials (GPPM) mission. The purpose of the Product Assurance Plan is to define the various requirements which are to be met through completion of the GPPM mission. The GPPM experiment is a space payload which will be flown in the shuttle's SPACEHAB module. The experiment will use microgravity to enable production of complex polymeric gas permeable materials. The second report described in the first section is a Fracture Analysis for the Mir Environmental Effects Payload (MEEP). The Fracture Analysis report is a summary of the fracture control classifications for all structural elements of the MEEP. The MEEP hardware consists of four experiment carriers, each of which contains an experiment container holding a passive experiment. The MEEP hardware will be attached to the cargo bay of the space shuttle. It will be transferred by Extravehicular Activity and mounted on the Mir space station. The second section of this report describes my experiences in the RVQA lab. I listed the different equipment I used at the lab and their functions. I described the extensive inspection process that must be completed for spaceflight hardware. Included, at the end of this section, are pictures of most of the equipment used in the lab. There is a summary sheet located at the end of this report. It briefly describes the valuable experience I have gained at NASA this summer and what I will be able to take

  11. Radiation Hardness Assurance (RHA) Guideline

    NASA Technical Reports Server (NTRS)

    Campola, Michael J.

    2016-01-01

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

  12. EPA Quality Assurance Policy Statement

    EPA Pesticide Factsheets

    This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  13. Implementation of Oak Ridge National Laboratory Software Quality Assurance Requirements for COMSOL 3.4

    SciTech Connect

    Freels, James D

    2008-01-01

    It is desirable for nuclear safety-related calculations to be performed at the Oak Ridge National Laboratory (ORNL) using COMSOL. The Department of Energy (DOE) has mandated that ORNL will incorporate software quality assurance (SQA) with special attention to nuclear safety-related software applications. The author has developed a procedure for implementing these DOE-mandated SQA requirements on nuclear safety-related software applicable to the High Flux Isotope Reactor (HFIR). This paper will describe how this procedure will be implemented for COMSOL so that nuclear safety-related calculations may be performed.

  14. 16 CFR 1101.34 - Reasonable steps to assure information release is “reasonably related to effectuating the...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 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... Administers § 1101.34 Reasonable steps to assure information release is “reasonably related to...

  15. 16 CFR 1101.34 - Reasonable steps to assure information release is “reasonably related to effectuating the...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 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...

  16. Blood sugar test - blood

    MedlinePlus

    ... sugar; Blood sugar level; Fasting blood sugar; Glucose test; Diabetic screening - blood sugar test; Diabetes - blood sugar test ... The test may be done in the following ways: After you have not eaten anything for at least 8 ...

  17. 49 CFR 385.319 - What happens after completion of the safety audit?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false What happens after completion of the safety audit... REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.319 What happens after completion of the safety audit? (a) Upon completion of the safety audit, the auditor will review the...

  18. 49 CFR 385.309 - What is the purpose of the safety audit?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  20. 49 CFR 385.313 - Who will conduct the safety audit?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  1. 49 CFR 385.333 - What happens at the end of the 18-month safety monitoring period?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.333 What happens at the end of the 18-month safety monitoring period? (a) If a safety audit has been performed within... the same basis as any other carrier. (d) If a safety audit or compliance review has not been...

  2. Quality Assurance Project Plan for waste tank vapor characterization

    SciTech Connect

    Suydam, C.D. Jr.

    1993-12-01

    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.

  3. UMTRA technical assistance contractor quality assurance program plan

    SciTech Connect

    Not Available

    1994-10-01

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

  4. An Incremental Life-cycle Assurance Strategy for Critical System Certification

    DTIC Science & Technology

    2014-11-04

    safety process uses many individual methods and analyses, e.g. • hazard analysis • failure modes and effects analysis • fault trees • Markov...processes Goal: a general facility for modeling fault /error/failure behaviors that can be used for several modeling and analysis activities...Integration Strategy with SAE AADL Improving the Quality of Requirements Architecture Fault Modeling and Safety Incremental Life-cycle Assurance

  5. Product assurance technology efforts: Technical accomplishments

    NASA Technical Reports Server (NTRS)

    1985-01-01

    Product assurance technology topics addressed include: wafer acceptance procedures, test chips, test structures, test chip methodology, fault models, and the Combined Release and Radiation Effects Satellite test chip.

  6. 42 CFR 93.301 - Institutional assurances.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... assurances. (a) General policy. An institution with PHS supported biomedical or behavioral research, research... biomedical and behavioral research, research training, or activities related to that research or...

  7. 42 CFR 93.301 - Institutional assurances.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... assurances. (a) General policy. An institution with PHS supported biomedical or behavioral research, research... biomedical and behavioral research, research training, or activities related to that research or...

  8. 42 CFR 93.301 - Institutional assurances.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... assurances. (a) General policy. An institution with PHS supported biomedical or behavioral research, research... biomedical and behavioral research, research training, or activities related to that research or...

  9. 42 CFR 93.301 - Institutional assurances.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... assurances. (a) General policy. An institution with PHS supported biomedical or behavioral research, research... biomedical and behavioral research, research training, or activities related to that research or...

  10. 42 CFR 93.301 - Institutional assurances.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... assurances. (a) General policy. An institution with PHS supported biomedical or behavioral research, research... biomedical and behavioral research, research training, or activities related to that research or...

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

    PubMed Central

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

    2014-01-01

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

  12. 49 CFR 385.327 - May a new entrant request an administrative review of a determination of a failed safety audit?

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance...) take effect, the new entrant must submit its request no later than 15 days from the date of the...

  13. 49 CFR 385.327 - May a new entrant request an administrative review of a determination of a failed safety audit?

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance...) take effect, the new entrant must submit its request no later than 15 days from the date of the...

  14. 49 CFR 385.327 - May a new entrant request an administrative review of a determination of a failed safety audit?

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance...) take effect, the new entrant must submit its request no later than 15 days from the date of the...

  15. 49 CFR 385.327 - May a new entrant request an administrative review of a determination of a failed safety audit?

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance...) take effect, the new entrant must submit its request no later than 15 days from the date of the...

  16. 49 CFR 385.327 - May a new entrant request an administrative review of a determination of a failed safety audit?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance...) take effect, the new entrant must submit its request no later than 15 days from the date of the...

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

    PubMed

    Tembuyser, Lien; Dequeker, Elisabeth M C

    2016-01-01

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

  18. 10 CFR 72.248 - Safety analysis report updating.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Safety analysis report updating. 72.248 Section 72.248... Approval of Spent Fuel Storage Casks § 72.248 Safety analysis report updating. (a) Each certificate holder... section, the final safety analysis report (FSAR) to assure that the information included in the...

  19. Blood typing

    MedlinePlus

    ... ABO blood typing; Blood group; Anemia - immune hemolytic blood type; ABO blood type; A blood type; AB blood type; O blood type ... The 2 steps above can accurately determine your blood type. Rh typing uses a method similar to ABO ...

  20. Cesium legacy safety project management work plan

    SciTech Connect

    Durham, J.S.

    1998-04-21

    This Management Work Plan (MWP) describes the process flow, quality assurance controls, and the Environment, Safety, and Health requirements of the Cesium Legacy Safety Project. This MWP provides an overview of the project goals and methods for repackaging the non-conforming Type W overpacks and packaging the CsCl powder and pellets. This MWP is not intended to apply to other activities associated with the CsCl Legacy Safety Program (i.e., clean out of South Cell).

  1. Professionalism, Profession and Quality Assurance Practitioners in External Quality Assurance Agencies in Higher Education

    ERIC Educational Resources Information Center

    Cheung, Jordan C. M.

    2015-01-01

    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…

  2. NASA's Software Safety Standard

    NASA Technical Reports Server (NTRS)

    Ramsay, Christopher M.

    2005-01-01

    NASA (National Aeronautics and Space Administration) relies more and more on software to control, monitor, and verify its safety critical systems, facilities and operations. Since the 1960's there has hardly been a spacecraft (manned or unmanned) launched that did not have a computer on board that provided vital command and control services. Despite this growing dependence on software control and monitoring, there has been no consistent application of software safety practices and methodology to NASA's projects with safety critical software. Led by the NASA Headquarters Office of Safety and Mission Assurance, the NASA Software Safety Standard (STD-18l9.13B) has recently undergone a significant update in an attempt to provide that consistency. This paper will discuss the key features of the new NASA Software Safety Standard. It will start with a brief history of the use and development of software in safety critical applications at NASA. It will then give a brief overview of the NASA Software Working Group and the approach it took to revise the software engineering process across the Agency.

  3. 49 CFR 385.321 - What failures of safety management practices disclosed by the safety audit will result in a...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385...)—Operating a motor vehicle without having in effect the required minimum levels of financial responsibility coverage Single occurrence. 10. § 387.31(a)—Operating a passenger carrying vehicle without having in...

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

    NASA Technical Reports Server (NTRS)

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

    2015-01-01

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

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

    NASA Technical Reports Server (NTRS)

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

    2015-01-01

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

  6. Quality assurance and dosimetric evaluation for an endocavitary unit.

    PubMed

    Klein, E E; Purdy, J A

    1994-01-01

    The use of endocavitary contact therapy for selected rectal carcinomas continues to be an effective treatment option. Very small volumes are treated with an extremely high dose rate associated with rapid fall-off in depth and an overall high dose. The clinical benefits of the high dose rate leads to dosimetric and quality-assurance challenges. In addition, the operating room environment creates concerns in terms of dosimetry and radiation safety due to varying room line voltages and uncontrolled environments. The unit at our facility delivers 50 kVp X-rays using an SSD of 35 mm with lead-lined procotscopes of 24 and 29 mm. The dose rate is approximately 10 Gy per minute. Establishment of daily, monthly, and annual quality assurance reviews have been made and assessed. Parallel-plate ionization chambers measure outputs and relative depth dose with different phantoms. Silver bromide film is used to evaluate beam profiles. An electron diode system was chosen for day-of-treatment output checks. An ion chamber survey meter measures scatter and leakage exposure rates. Day-of-treatment output checks have assured output stability in various operating rooms. Trends in output have been confirmed by monthly ion chamber checks. Percent depth dose measurements carried out in liquid water compared well with accepted published data as did corrected polystyrene measurements. Radiation survey measurements detected acceptable exposure rate levels. The established comprehensive quality assurance program incorporates cross checking with multiple dosimetry systems. The confidence level of dose delivery has increased with the introduction of a day-of-treatment output checks.(ABSTRACT TRUNCATED AT 250 WORDS)

  7. 75 FR 13342 - Pipeline Safety: Workshop on Distribution Pipeline Construction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-19

    ... practices in natural gas distribution pipeline construction management and quality control. This workshop... to inspection findings. (2) Distribution materials, Quality Assurance/Quality Control, related best... Construction AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Notice...

  8. Formal Approaches to Ensuring the Safety of Space Software

    NASA Technical Reports Server (NTRS)

    Denney, Ewen; Fischer, Bernd

    2006-01-01

    A viewgraph describing formal approaches taken to assure the safety of space software is presented. The topics include: 1) Certifiable Program Generation; 2) Certification Framework; 3) Annotation Generation; 4) Experiments; and 5) Future Work.

  9. 48 CFR 37.604 - Quality assurance surveillance plans.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Quality assurance... assurance surveillance plans. Requirements for quality assurance and quality assurance surveillance plans are in Subpart 46.4. The Government may either prepare the quality assurance surveillance plan...

  10. Formal Foundations for Hierarchical Safety Cases

    NASA Technical Reports Server (NTRS)

    Denney, Ewen; Pai, Ganesh; Whiteside, Iain

    2015-01-01

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

  11. Tool Use Within NASA Software Quality Assurance

    NASA Technical Reports Server (NTRS)

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

    2013-01-01

    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.

  12. Exploring Quality Assurance in Sixth Form Colleges

    ERIC Educational Resources Information Center

    Stoten, David William

    2012-01-01

    Purpose: This paper aims to focus on the changing nature of quality assurance systems within the sixth form college sector. Design/methodology/approach: Ten sixth form colleges were surveyed across England and staff from varying levels within college hierarchies questioned about how quality assurance systems were implemented. Research involved…

  13. Teacher Reaction to ICP Quality Assurance Procedures.

    ERIC Educational Resources Information Center

    Leonard, Ann

    An integral part of the Quality Assurance Manual developed by Southwest Regional Laboratory (SWRL) to accompany the Kindergarten Program is the end-of-program assessment of the Instructional Concepts Program (ICP). Following completion of ICP Quality Assurance assessment, four teachers were interviewed in order to gather information pertinent to…

  14. 7 CFR 652.7 - Quality assurance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 6 2011-01-01 2011-01-01 false Quality assurance. 652.7 Section 652.7 Agriculture... AGRICULTURE SUPPORT ACTIVITIES TECHNICAL SERVICE PROVIDER ASSISTANCE General Provisions § 652.7 Quality assurance. (a) NRCS will review, in consultation with the Farm Service Agency, as appropriate, the...

  15. 7 CFR 652.7 - Quality assurance.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 6 2013-01-01 2013-01-01 false Quality assurance. 652.7 Section 652.7 Agriculture... AGRICULTURE SUPPORT ACTIVITIES TECHNICAL SERVICE PROVIDER ASSISTANCE General Provisions § 652.7 Quality assurance. (a) NRCS will review, in consultation with the Farm Service Agency, as appropriate, the...

  16. 48 CFR 2453.246 - Quality Assurance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false 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....

  17. 7 CFR 652.7 - Quality assurance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 6 2010-01-01 2010-01-01 false Quality assurance. 652.7 Section 652.7 Agriculture... AGRICULTURE SUPPORT ACTIVITIES TECHNICAL SERVICE PROVIDER ASSISTANCE General Provisions § 652.7 Quality assurance. (a) NRCS will review, in consultation with the Farm Service Agency, as appropriate, the...

  18. 48 CFR 2453.246 - Quality Assurance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 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....

  19. 7 CFR 652.7 - Quality assurance.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 6 2014-01-01 2014-01-01 false Quality assurance. 652.7 Section 652.7 Agriculture... AGRICULTURE SUPPORT ACTIVITIES TECHNICAL SERVICE PROVIDER ASSISTANCE General Provisions § 652.7 Quality assurance. (a) NRCS will review, in consultation with the Farm Service Agency, as appropriate, the...

  20. 7 CFR 652.7 - Quality assurance.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 6 2012-01-01 2012-01-01 false Quality assurance. 652.7 Section 652.7 Agriculture... AGRICULTURE SUPPORT ACTIVITIES TECHNICAL SERVICE PROVIDER ASSISTANCE General Provisions § 652.7 Quality assurance. (a) NRCS will review, in consultation with the Farm Service Agency, as appropriate, the...

  1. 48 CFR 2453.246 - Quality Assurance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false 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....

  2. 48 CFR 2453.246 - Quality Assurance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false 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....

  3. 48 CFR 2453.246 - Quality Assurance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false 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....

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

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 1 2011-01-01 2011-01-01 false Assurance required. 15a.4 Section 15a.4 Agriculture Office of the Secretary of Agriculture EDUCATION PROGRAMS OR ACTIVITIES RECEIVING OR BENEFITTING FROM FEDERAL FINANCIAL ASSISTANCE Introduction § 15a.4 Assurance required. (a) General. Every application...

  5. 7 CFR 15a.4 - Assurance required.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 1 2012-01-01 2012-01-01 false Assurance required. 15a.4 Section 15a.4 Agriculture Office of the Secretary of Agriculture EDUCATION PROGRAMS OR ACTIVITIES RECEIVING OR BENEFITTING FROM FEDERAL FINANCIAL ASSISTANCE Introduction § 15a.4 Assurance required. (a) General. Every application...

  6. 7 CFR 15a.4 - Assurance required.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 1 2014-01-01 2014-01-01 false Assurance required. 15a.4 Section 15a.4 Agriculture Office of the Secretary of Agriculture EDUCATION PROGRAMS OR ACTIVITIES RECEIVING OR BENEFITTING FROM FEDERAL FINANCIAL ASSISTANCE Introduction § 15a.4 Assurance required. (a) General. Every application...

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

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 1 2013-01-01 2013-01-01 false Assurance required. 15a.4 Section 15a.4 Agriculture Office of the Secretary of Agriculture EDUCATION PROGRAMS OR ACTIVITIES RECEIVING OR BENEFITTING FROM FEDERAL FINANCIAL ASSISTANCE Introduction § 15a.4 Assurance required. (a) General. Every application...

  8. Quality assurance manual: Volume 2, Appendices

    SciTech Connect

    Oijala, J.E.

    1988-06-01

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

  9. Assurance Policy Evaluation - Spacecraft and Strategic Systems

    DTIC Science & Technology

    2014-09-17

    Requirements for Aviation, Space and Defense Organizations” and ISO 9001 :2008 “ Quality Management Systems – Requirements” as quality requirements to be...engineering, quality assurance, and reliability; and it should be used by programs in their acquisition process. We found three common program management ...systems engineering, design, manufacturing, testing, quality assurance, risk management , reliability, maintainability, and availability requirements to

  10. Quality Assurance Reconsidered: A Case Study

    ERIC Educational Resources Information Center

    Gynnild, Vidar

    2007-01-01

    This article examines an external evaluation of the quality assurance system at the Norwegian University of Science and Technology (NTNU) conducted by The Norwegian Agency for Quality Assurance in Higher Education (NOKUT). The external audit report along with internal reports provided by the seven faculties of the university served as the major…

  11. Quality Assurance in Sub-Saharan Africa

    ERIC Educational Resources Information Center

    Materu, Peter; Righetti, Petra

    2010-01-01

    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.…

  12. 34 CFR 110.23 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... NONDISCRIMINATION ON THE BASIS OF AGE IN PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE Duties of ED... which these regulations apply shall sign a written assurance, on a form specified by ED, that the... this assurance by reference in subsequent applications to ED. (b) Duration of obligation. (1) In...

  13. 34 CFR 110.23 - Assurances required.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... NONDISCRIMINATION ON THE BASIS OF AGE IN PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE Duties of ED... which these regulations apply shall sign a written assurance, on a form specified by ED, that the... this assurance by reference in subsequent applications to ED. (b) Duration of obligation. (1) In...

  14. 34 CFR 110.23 - Assurances required.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... NONDISCRIMINATION ON THE BASIS OF AGE IN PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE Duties of ED... which these regulations apply shall sign a written assurance, on a form specified by ED, that the... this assurance by reference in subsequent applications to ED. (b) Duration of obligation. (1) In...

  15. 34 CFR 110.23 - Assurances required.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... NONDISCRIMINATION ON THE BASIS OF AGE IN PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE Duties of ED... which these regulations apply shall sign a written assurance, on a form specified by ED, that the... this assurance by reference in subsequent applications to ED. (b) Duration of obligation. (1) In...

  16. 34 CFR 110.23 - Assurances required.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... NONDISCRIMINATION ON THE BASIS OF AGE IN PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE Duties of ED... which these regulations apply shall sign a written assurance, on a form specified by ED, that the... this assurance by reference in subsequent applications to ED. (b) Duration of obligation. (1) In...

  17. 36 CFR 6.10 - Financial assurance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 36 Parks, Forests, and Public Property 1 2011-07-01 2011-07-01 false Financial assurance. 6.10... WASTE DISPOSAL SITES IN UNITS OF THE NATIONAL PARK SYSTEM § 6.10 Financial assurance. (a) The Regional... deposit or the market value of such securities must be at least equal to the required sum of the...

  18. 43 CFR 27.4 - Assurances.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ..., RIGHTS-OF-WAY, PUBLIC LAND ORDERS, AND OTHER FEDERAL AUTHORIZATIONS GRANTED OR ISSUED UNDER TITLE II OF PUBLIC LAW 93-153 § 27.4 Assurances. Every application for a permit, right-of-way, public land order, or... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Assurances. 27.4 Section 27.4 Public...

  19. Ontario's Quality Assurance Framework: A Critical Response

    ERIC Educational Resources Information Center

    Heap, James

    2013-01-01

    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…

  20. Evaluation of Quality Assurance Programs for Externships.

    ERIC Educational Resources Information Center

    Ruskiewicz, Joseph

    1982-01-01

    The procedures of the Pennsylvania College of Optometry's Office of External Educational Programs are reviewed to show how quality assurance techniques can be categorized. The format was designed to evaluate quality assurance procedures for both the educational and service aspects of eye care. (MLW)