Science.gov

Sample records for assuring blood safety

  1. Safety Assurance in Obstetrical Ultrasound

    PubMed Central

    Miller, Douglas L

    2008-01-01

    Safety assurance for diagnostic ultrasound in obstetrics began with a tacit assumption of safety allowed by a federal law enacted in 1976 for then-existing medical ultrasound equipment. The implementation of the 510(k) pre-market approval process for diagnostic ultrasound resulted in the establishment of guideline upper limits for several examination categories in 1985. The obstetrical category has undergone substantial evolution from initial limits (I. e., 46 mW/cm2 spatial peak temporal average (SPTA) intensity) set in 1985. Thermal and mechanical exposure indices, which are displayed on-screen according to an Output Display Standard (ODS), were developed for safety assurance with relaxed upper limits. In 1992, with the adoption of the ODS, the allowable output for obstetrical ultrasound was increased both in terms of the average exposure (e. g. to a possible 720 mW/cm2 SPTA intensity) and of the peak exposure (via the Mechanical Index). There has been little or no subsequent research with the modern obstetrical ultrasound machines to systematically assess potential risks to the fetus using either relevant animal models of obstetrical exposure or human epidemiology studies. The assurance of safety for obstetrical ultrasound therefore is supported by three ongoing means: (I) review of a substantial but uncoordinated bioeffect research literature, (ii) the theoretical evaluation of diagnostic ultrasound exposure in terms of thermal and nonthermal mechanisms for bioeffects, and (iii) the skill and knowledge of professional sonographers. At this time, there is no specific reason to suspect that there is any significant health risk to the fetus or mother from exposure to diagnostic ultrasound in obstetrics. This assurance of safety supports the prudent use of diagnostic ultrasound in obstetrics by trained professionals for any medically indicated examination. PMID:18450141

  2. Safety assurance in obstetrical ultrasound.

    PubMed

    Miller, Douglas L

    2008-04-01

    Safety assurance for diagnostic ultrasound in obstetrics began with a tacit assumption of safety allowed by a federal law enacted in 1976 for then-existing medical ultrasound equipment. The implementation of the 510(k) pre-market-approval process for diagnostic ultrasound resulted in the establishment of guideline upper limits for several examination categories in 1985. The obstetrical category has undergone substantial evolution from initial limits (ie, 46 mW/cm2 spatial peak temporal average [SPTA] intensity) set in 1985. Thermal and mechanical exposure indices, which are displayed onscreen according to an Output Display Standard, were developed for safety assurance with relaxed upper limits. In 1992, with the adoption of the Output Display Standard, the allowable output for obstetrical ultrasound was increased in terms of both the average exposure (eg, to a possible 720 mW/cm2 SPTA intensity) and the peak exposure (via the Mechanical Index). There has been little or no subsequent research with the modern obstetrical ultrasound machines to systematically assess potential risks to the fetus using either relevant animal models of obstetrical exposure or human epidemiology studies. The assurance of safety for obstetrical ultrasound therefore is supported by three ongoing means: (1) review of a substantial but uncoordinated bioeffect research literature; (2) the theoretical evaluation of diagnostic ultrasound exposure in terms of thermal and nonthermal mechanisms for bioeffects; and (3) the skill and knowledge of professional sonographers. At this time, there is no specific reason to suspect that there is any significant health risk to the fetus or mother from exposure to diagnostic ultrasound in obstetrics. This assurance of safety supports the prudent use of diagnostic ultrasound in obstetrics by trained professionals for any medically indicated examination. PMID:18450141

  3. Safety Assurance for ATR Irradiations

    SciTech Connect

    S. Blaine Grover

    2006-10-01

    The Advanced Test Reactor (ATR) located at the Idaho National Laboratory (INL) is the world’s premiere test reactor for performing high fluence, large volume, irradiation test programs. The ATR has many capabilities and a wide variety of tests are performed in this truly one of a kind reactor, including isotope production, simple self-contained static capsule experiments, instrumented/controlled experiments, and loop testing under pressurized water conditions. Along with the five pressurized water loops, ATR may also have gas (temperature controlled) lead experiments, fuel boosted fast flux experiments, and static sealed capsules all in the core at the same time. In addition, any or all of these tests may contain fuel or moderating materials that can affect reactivity levels in the ATR core. Therefore the safety analyses required to ensure safe operation of each experiment as well as the reactor itself are complex. Each test has to be evaluated against stringent reactor control safety criteria, as well as the effects it could have on adjacent tests and the reactor as well as the consequences of those effects. The safety analyses of each experiment are summarized in a document entitled the Experiment Safety Assurance Package (ESAP). The ESAP references and employs the results of the reactor physics, thermal, hydraulic, stress, seismic, vibration, and all other analyses necessary to ensure the experiment can be irradiated safely in the ATR. The requirements for reactivity worth, chemistry compatibilities, pressure limitations, material issues, etc. are all specified in the Technical Safety Requirements and the Upgraded Final Safety Analysis Report (UFSAR) for the ATR. This paper discusses the ESAP process, types of analyses, types of safety requirements and the approvals necessary to ensure an experiment can be safely irradiated in the ATR.

  4. 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

  5. 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.

  6. 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.

  7. Blood Gas Quality Assurance System

    PubMed Central

    Pickler, Lee

    1979-01-01

    Quality assurance of health care delivery is as important as the Voluntary Effort (VE) program is to the health care industry. These two seemingly converse positions require a delicate balance. One way this balance is met is by more effectively utilizing current equipment through improved systems.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. Software Quality Assurance for Nuclear Safety Systems

    SciTech Connect

    Sparkman, D R; Lagdon, R

    2004-05-16

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

  14. 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.

  15. 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.

  16. Evaluation of reliability assurance approaches to operational nuclear safety

    SciTech Connect

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

    1984-01-01

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

  17. New safety assurance for biological skin covers.

    PubMed

    Mĕricka, P; Straková, H; Cermák, P; Stĕpánová, V; Hradecký, Z; Drahosová, M

    2002-01-01

    The described system of safety assurance of cryopreserved allogeneic and xenogeneic dermoepidermal transplants comprises serological examination of deceased tissue donors, long-term storage of sera of all donors, microbiological control of prepared allogeneic and xenogeneic dermoepidermal grafts, labelling of released tissue grafts and monitoring of temperatures inside the mechanical freezer (-80 degrees C). From a total number of 76 donors from whom tissues were collected for transplantation during 1999-2001, tissues were discarded in two instances. One because of a positive HBsAg test, the others second one because of presence of anti-HTLV antibodies. In xenogeneic dermoepidermal grafts, out of a total number of 1,203 grafts prepared during the same period, 84 (6.9%) were discarded because of the presence of pathogeneic or potentially pathogeneic microbes. The system of labelling released grafts makes unequivocal identification of the pathway from recipient to donor possible, while at the same time respecting the anonymous character of the donor's data. In xenogeneic grafts it ensures the identification of the appropriate batch. Storage of cryopreserved biological skin covers at a temperature of -80 degrees C in low temperature cabinets with emergency back-up cooling with liquid nitrogen and a supplementary source of electric power, proved very useful. The system responds to the gradual implementation of the principles of Quality Management System ISO 9000 and Good Manufacturing Practice into the activities of tissue banks. Further tightening of the demands for the safety of allo- and xeno-transplantation is foreseen in conjunction with the occurrence of transmissible spongiform encephalopathy and porcine retroviruses. PMID:12053432

  18. 78 FR 54510 - New Entrant Safety Assurance Program Operational Test

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-04

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

  19. 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.

  20. 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. PMID:26778104

  1. Ensuring patient safety blood transfusision.

    PubMed

    Higgins, Dan; Jones, David

    Blood transfusion is a relatively common procedure, and is a necessary skill for many nurses working in a range of clinical environments. Blood transfusion carries a degree of risk, and avoidable mistakes can result in serious or fatal consequences. Adverse events are largely associated with human error, so know-ledge and skills are essential. While local and national policies go some way to reducing clinical risk, a comprehensive knowledge of the blood grouping system and compatibility, and the ability to recognise, respond to and report reactions, are also necessary to optimise patient safety. An online Nursing Times Learning unit on safe blood transfusion will be launched next month. PMID:23505939

  2. 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.

  3. Virginia Tech: The Challenge of Assuring Safety

    ERIC Educational Resources Information Center

    Rikleen, Lauren Stiller

    2007-01-01

    The recent events at Virginia Tech reinforce the idea that nothing is more fundamental for college leaders to address than campus security and safety. After the tears, the makeshift memorials, and the intensely painful series of funerals, higher education must come to grips with the fact that it has just had its own September 11. Assessing and…

  4. 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.

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

    SciTech Connect

    T. A. Tomberlin; S. B. Grover

    2004-11-01

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

  6. 23 CFR Appendix C to Part 1200 - ASSURANCES FOR TEEN TRAFFIC SAFETY PROGRAM

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 23 Highways 1 2013-04-01 2013-04-01 false ASSURANCES FOR TEEN TRAFFIC SAFETY PROGRAM C APPENDIX C... STATE HIGHWAY SAFETY GRANT PROGRAMS Pt. 1200, App. C APPENDIX C TO PART 1200—ASSURANCES FOR TEEN TRAFFIC SAFETY PROGRAM State: Fiscal Year: The State has elected to implement a Teen Traffic Safety...

  7. 23 CFR Appendix C to Part 1200 - Assurances for Teen Traffic Safety Program

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 23 Highways 1 2014-04-01 2014-04-01 false Assurances for Teen Traffic Safety Program C Appendix C... STATE HIGHWAY SAFETY GRANT PROGRAMS Pt. 1200, App. C Appendix C to Part 1200—Assurances for Teen Traffic Safety Program State: Fiscal Year: The State has elected to implement a Teen Traffic Safety...

  8. Nutraceutical/drug/anti-terrorism safety assurance through traceability.

    PubMed

    Lachance, Paul A

    2004-04-15

    Nutraceuticals are naturally occurring/derived bioactive compounds that are reported to have health benefits. The delivery systems for nutraceuticals are foods (functional foods), supplements, or both. Drugs are designed to have medicinal properties for the prevention and treatment of identified diseases or signs and symptoms of disease. Counterfeit drugs contain either placebo, materials not identified in the labeling or substandard or impure materials, which may produce untoward pharmacological or toxicological effects. In addition, the consumer has the right to microbiological safety and prevention from adverse exposure to hazardous chemical(s), and other adverse compounds. Nutraceutical/drug delivery systems are viewed as approaches to (1) enhanced consumer health, (2) decreased healthcare costs, and (3) enhanced economic development. Therefore, the nutra/pharma/ceutical industry is reliant upon a strong underpinning of diversified research that addresses safety and assures chemical and biological efficacy. Significant safety through traceability can be assured by the coupling of the technologies of (a) global positioning (GPS); (b) bar/chip coding; and (c) hazard analysis critical control point (HACCP) management, coupled to rapid nanotechnology marker assays now under development. PMID:15068822

  9. 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. PMID:15650526

  10. 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.

  11. Safety of the Blood Supply in Latin America

    PubMed Central

    Schmunis, Gabriel A.; Cruz, Jose R.

    2005-01-01

    Appropriate selection of donors, use of sensitive screening tests, and the application of a mandatory quality assurance system are essential to maintain the safety of the blood supply. Laws, decrees, norms, and/or regulations covering most of these aspects of blood transfusion exist in 16 of the 17 countries in Latin America that are the subject of this review. In 17 countries, there is an information system that, although still incomplete (there are no official reports on adverse events and incidents), allows us to establish progress made on the status of the blood supply since 1993. Most advances originated in increased screening coverage for infectious diseases and better quality assurance. However, in 2001 to 2002, tainted blood may have caused infections in 12 of the 17 countries; no country reached the number of donors considered adequate, i.e., 5% of the population, to avoid blood shortages, or decreased significantly the number of blood banks, although larger blood banks are more efficient and take advantage of economies of scale. In those years, paid donors still existed in four countries and replacement donors made up >75% of the blood donors in another eight countries. In addition, countries did not report the number of voluntary donors who were repeat donors, i.e., the healthiest category. In spite of progress made, more improvements are needed. PMID:15653816

  12. 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. PMID:17052733

  13. 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.

  14. Work Done For the Safety and Assurance Directorate

    NASA Technical Reports Server (NTRS)

    Struhar, Paul T., Jr.

    2004-01-01

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

  15. 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.

  16. Software quality assurance plans for safety-critical software

    SciTech Connect

    Liddle, P.

    2006-07-01

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

  17. 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.

  18. 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.

  19. 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. PMID:23171300

  20. 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.

  1. 30 CFR 250.806 - Safety and pollution prevention equipment quality assurance requirements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  2. 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.

  3. 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. PMID:26065802

  4. [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. PMID:25284434

  5. Evaluation of the safety assurance level for Salmonella spp. throughout the food production chain in Switzerland.

    PubMed

    Sauli, I; Danuser, J; Wenk, C; Stärk, K D C

    2003-07-01

    In Switzerland. the safeguarding of food is the responsibility of industry, organizations, and governmental authorities. The dispersion of the tasks and the diversity of implemented safety measures among involved stakeholders do not allow a general overview of the national safety assurance level provided. A comprehensive evaluation of the level of safety assurance provided for foodborne pathogens such as Salmonella spp. is therefore lacking, and the prevalence of Salmonella spp. at various points in the food production chain is not known. The objectives of this study were to (i) collect data on safety measures implemented throughout the food production chain in Switzerland regarding Salmonella spp.; (ii) evaluate the safety assurance level for Salmonella spp. at each step of the production chain for chicken meat, pork, beef, and milk and dairy products (bovine origin); and (iii) gather data on the prevalence of the pathogen at each step. Data on implemented safety assurance measures for Salmonella spp. were gathered from the various stakeholders in the food production chain. The data were analyzed by a semiquantitative method that considered the quality and relevance of the implemented safety measures for Salmonella spp. The safety assurance level for Salmonella spp. was evaluated from "no safety assurance" to "very good safety assurance." Available results of testing for Salmonella spp. from 1998 to 2000 were used for calculating the prevalence of the pathogen throughout the food production chain. The results showed a varying safety assurance level for Salmonella spp. throughout the food production chain. Strengths (e.g., feed production for chickens) and weaknesses (e.g., pork production) were observed. These results serve as a basis for a rational optimization of the system. PMID:12870745

  6. [Viral safety concept: application to blood and blood products].

    PubMed

    Trouvin, Jean-Hugues

    2005-11-30

    Safety of blood and its derivatives, with regards to the risk of transmission of infectious agents such as viruses or non conventional agents, relies on a series of general principles for which national and European guidance and regulations have been drawn and regularly updated. Three main criteria contribute to the safety of these products: knowledge and control of the quality of blood or plasma as the starting material, the efficiency of the manufacturing process to remove/inactivate adventitious agents, and the testing done during the production process. In addition, vigilance routinely exercised on the products used in daily practice increases the confidence in these health products. PMID:16419908

  7. 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.

  8. 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…

  9. 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

  10. [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. PMID:25578550

  11. 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... pollution prevention equipment quality assurance requirements. (a) General requirements. (1) Except as provided in paragraph (b)(1) of this section, you may install only certified safety and...

  12. 75 FR 6004 - Notice of Intent To Prepare a Draft Environmental Impact Statement and Dam Safety Assurance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-05

    ... Statement and Dam Safety Assurance Program Modification Report for the Isabella Dam Project, Kern County, CA..., and hydrologic dam safety concerns at the Isabella Lake main and auxiliary dams. Isabella Lake is... proposed action is being conducted through the Corps' Dam Safety Assurance Program (DSAP) for...

  13. 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).

  14. 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.

  15. 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.

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

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 4 2013-10-01 2013-10-01 false Safety Assurance Criteria and Processes C Appendix C to Part 236 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RULES, STANDARDS, AND INSTRUCTIONS GOVERNING THE INSTALLATION, INSPECTION, MAINTENANCE, AND REPAIR...

  17. 49 CFR Appendix C to Part 236 - Safety Assurance Criteria and Processes

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 4 2014-10-01 2014-10-01 false Safety Assurance Criteria and Processes C Appendix C to Part 236 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RULES, STANDARDS, AND INSTRUCTIONS GOVERNING THE INSTALLATION, INSPECTION, MAINTENANCE, AND REPAIR...

  18. 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.

  19. 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…

  20. Development of a xenon/computed tomography cerebral blood flow quality assurance phantom

    SciTech Connect

    Good, W.F.; Gur, D.; Herron, J.M.; Kennedy, W.H.

    1987-09-01

    A simple, easy to use, quality assurance and performance test phantom was developed for the xenon/computed tomography (CT) cerebral blood flow method. The phantom combines an inhalation system which allows for the simulation of xenon buildup or washout in the arterial blood as well as a multisection translatable cylinder in which several sections can be scanned during a preselected protocol to simulate the CT enhancement in brain tissue during a study. The phantom and scanning protocol are described and their use is demonstrated. The results compare favorably to the theoretically expected fast, intermediate, and slow flow values designed into the phantom.

  1. 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.

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

    PubMed

    Stankovic, Ana K

    2004-12-01

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

  3. 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. PMID:22189177

  4. Quality assuring HIV point of care testing using whole blood samples.

    PubMed

    Dare-Smith, Raellene; Badrick, Tony; Cunningham, Philip; Kesson, Alison; Badman, Susan

    2016-08-01

    The Royal College of Pathologists Australasia Quality Assurance Programs (RCPAQAP), have offered dedicated external quality assurance (EQA) for HIV point of care testing (PoCT) since 2011. Prior to this, EQA for these tests was available within the comprehensive human immunodeficiency virus (HIV) module. EQA testing for HIV has typically involved the supply of serum or plasma, while in the clinic or community based settings HIV PoCT is generally performed using whole blood obtained by capillary finger-stick collection. RCPAQAP has offered EQA for HIV PoCT using stabilised whole blood since 2014. A total of eight surveys have been undertaken over a period of 2 years from 2014 to 2015. Of the 962 responses received, the overall consensus rate was found to be 98% (941/962). A total of 21 errors were detected. The majority of errors were attributable to false reactive HIV p24 antigen results (9/21, 43%), followed by false reactive HIV antibody results (8/21, 38%). There were 4/21 (19%) false negative HIV antibody results and no false negative HIV p24 antigen results reported. Overall performance was observed to vary minimally between surveys, from a low of 94% up to 99% concordant. Encouraging levels of testing proficiency for HIV PoCT are indicated by these data, but they also confirm the need for HIV PoCT sites to participate in external quality assurance programs to ensure the ongoing provision of high quality patient care. PMID:27306578

  5. Construction of a Drug Safety Assurance Information System Based on Clinical Genotyping

    PubMed Central

    Springer, John A.; Iannotti, Nicholas V.; Sprague, Jon E.; Kane, Michael D.

    2012-01-01

    To capitalize on the vast potential of patient genetic information to aid in assuring drug safety, a substantial effort is needed in both the training of healthcare professionals and the operational enablement of clinical environments. Our research aims to satisfy these needs through the development of a drug safety assurance information system (GeneScription) based on clinical genotyping that utilizes patient-specific genetic information to predict and prevent adverse drug responses. In this paper, we present the motivations for this work, the algorithms at the heart of GeneScription, and a discussion of our system and its uses. We also describe our efforts to validate GeneScription through its evaluation by practicing pharmacists and pharmacy professors and its repeated use in training pharmacists. The positive assessment of the GeneScription software tool by these domain experts provides strong validation of the importance, accuracy, and effectiveness of GeneScription. PMID:25969745

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

    SciTech Connect

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

    1989-10-31

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

  7. 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.

  8. 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.

  9. 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.

  10. The FAA's Approach to Quality Assurance in the Flight Safety Analysis of Launch and Reentry Vehicles

    NASA Astrophysics Data System (ADS)

    Murray, Daniel P.; Weil, Andre

    2010-09-01

    The U.S. Federal Aviation Administration(FAA) Office of Commercial Space Transportation’s safety mission is to ensure protection of the public, property, and the national security and foreign policy interests of the United States during commercial launch and reentry activities. As part of this mission, the FAA issues licenses to the operators of launch and reentry vehicles who successfully demonstrate compliance with FAA regulations. To meet these regulations, vehicle operators submit an application that contains, among other things, flight safety analyses of their proposed missions. In the process of evaluating these submitted analyses, the FAA often conducts its own independent analyses, using input data from the submitted license application. These analyses are conducted according to approved procedures using industry developed tools. To assist in achieving the highest levels of quality in these independent analyses, the FAA has developed a quality assurance program that consists of multiple levels of review. These reviews rely on the work of multiple teams, as well as additional, independently performed work of support contractors. This paper describes the FAA’s quality assurance process for flight safety analyses. Members of the commercial space industry may find that elements of this process can be easily applied to their own analyses, improving the quality of the material they submit to the FAA in their license applications.

  11. 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). PMID:17281868

  12. 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.

  13. 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.

  14. 75 FR 22758 - Notice of Intent To Prepare a Draft Environmental Impact Statement and Dam Safety Assurance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-30

    ... Statement and Dam Safety Assurance Program Modification Report for the Martis Creek Dam Project, Nevada... the Federal action to remediate seismic, seepage, and hydrologic dam safety concerns at the Martis Creek Dam. Martis Creek Dam is located about two miles upstream of the confluence of Martis Creek...

  15. 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.

  16. Engineering for safety assurance in MRI: analytical, numerical and experimental dosimetry.

    PubMed

    Hartwig, Valentina

    2015-06-01

    Magnetic resonance imaging (MRI) is considered a safe technology since it does not use ionizing radiation with high energy to detach electrons from atoms or molecules. However, as in any healthcare intervention, even in an MRI diagnostic procedure there are intrinsic hazards that must be understood and taken into consideration. Moreover, given the increasing number of clinical MRI examinations and the widespread availability of MR scanners with high static magnetic fields (>3T), the consideration of possible risks and health effects associated with MRI procedures is gaining in importance and the term "dosimetry" has begun to be used also for non ionizing techniques as MRI. Engineering techniques are increasingly used in MRI to explain the interactions between electromagnetic fields and the human body, analyze aspects relative to signal and image generation, and assure patient and staff safety and comfort. In this review some engineering methods to quantify the interactions between MR fields and biological tissues will be reviewed and cataloged to aid the readers in finding resources for their own applications in MRI safety assurance. This paper should not be intended as another review of the biological effects of MRI but, for the reader's convenience, the possible hazards for each kind of MR magnetic field, will be briefly described. PMID:25660641

  17. 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. PMID:18952706

  18. [Ethological competence of Perm Territory dwellers in the assurance of personal infection safety].

    PubMed

    Merzlova, N B; Serova, I A; Iagodina, A Iu

    2014-01-01

    The authors attempted to analyze preventive measures against infectious and parasitic diseases, which were used domestically by the Perm Territory population, their conjugacy with the stereotypes of attitude towards domestic animals, as well as behavioral features of compliance andcompetence in the assurance of infection safety. The found gaps in the assurance of personal infection safety (drinking unboiled water, unprotected sex, disregard of helminth prevention in domestic animals, and unwillingness to go in for sports) are coherent with the epidemiological situation in the Perm Territory and to our clinical and laboratory study of the patients of the Perm Territory Children's Clinical Hospital in 2011. Enzyme immunoassay (EIA) was used to examine 10075 patients for helminths and protozoa; parasitic diseases were detected in 2047 (20.3%) persons. The diagnostic titer of antibodies to Toxocara antigens was revealed in 677 (11.8%) children of 5700 patients examined for toxocariasis; that for Opisthorchis antigens was in 595 (37.7%) of 1578 examined for Opisthorchis infestation. The diagnostic titers for echinococcosis was found in 9 (0.75%) of 1198 patients; later on the diagnosis of hydatid disease was verified by epidemiological, clinical, and laboratory studies. Despite the inadequate informative value of EIA for the diagnosis of giardiasis, high antibody titers to Lamblia antigens were detected in 766 (47.9%) of 1599 children. PMID:25296422

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

    PubMed

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

    2014-02-01

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

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

    PubMed

    Gerber, Karen L; Freeman, Kathleen P

    2016-03-01

    Portable blood glucose meters (PBGM, glucometers) are a convenient, cost effective, and quick means to assess patient blood glucose concentration. The number of commercially available PBGM is constantly increasing, making it challenging to determine whether certain glucometers may have benefits over others for veterinary testing. The challenge in selection of an appropriate glucometer from a quality perspective is compounded by the variety of analytic methods used to quantify glucose concentrations and disparate statistical analysis in many published studies. These guidelines were developed as part of the ASVCP QALS committee response to establish recommendations to improve the quality of testing using point-of-care testing (POCT) handheld and benchtop devices in veterinary medicine. They are intended for clinical pathologists and laboratory professionals to provide them with background knowledge and specific recommendations for quality assurance (QA) and quality control (QC), and to serve as a resource to assist the provision of advice to veterinarians and technicians to improve the quality of results obtained when using PBGM. These guidelines are not intended to be all-inclusive; rather they provide a minimum standard for management of PBGM in the veterinary setting. PMID:26748942

  1. 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.

  2. 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.

  3. 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. PMID:21170188

  4. The status of blood safety in ECO member states

    PubMed Central

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

    2015-01-01

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

  5. 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.

  6. 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.

  7. 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)

  8. 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.

  9. 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

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

    SciTech Connect

    Helton, Jon Craig; Pilch, Martin M.; Sallaberry, Cedric M.

    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.

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

    SciTech Connect

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

    1995-06-01

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

  12. 76 FR 76732 - Nominations to the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-08

    ... HUMAN SERVICES Nominations to the Advisory Committee on Blood Safety and Availability AGENCY: Office of... appointment as members of the Advisory Committee on Blood Safety and Availability (ACBSA). ACBSA is a Federal... Mr. James Berger, Acting Director, Blood Safety and Availability, Office of the Assistant...

  13. 76 FR 15982 - Nominations to the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-22

    ... HUMAN SERVICES Nominations to the Advisory Committee on Blood Safety and Availability AGENCY: Office of... qualified individuals to be considered for appointment as members of the Advisory Committee on Blood Safety... Health Advisor for Blood, Organ and Tissue Safety; Office of Assistant Secretary for Health;...

  14. 76 FR 68192 - Meeting of the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-03

    ... HUMAN SERVICES Meeting of the Advisory Committee on Blood Safety and Availability AGENCY: Department of... Human Services is hereby giving notice that the Advisory Committee on Blood Safety and Availability... availability of blood and blood products. The agenda for the meeting includes discussion by the Committee...

  15. 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

    ... HUMAN SERVICES Nominations to the Advisory Committee on Blood and Tissue Safety and Availability AGENCY... nominations of qualified individuals to be considered for appointment to the Advisory Committee on Blood and... Advisor for Blood Policy; Division of Blood and Tissue Safety and Availability, Office of HIV/AIDS...

  16. 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. PMID:27112999

  17. 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...

  18. 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...

  19. 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...

  20. Bacteriological Safety of Blood Collected for Transfusion at University of Gondar Hospital Blood Bank, Northwest Ethiopia

    PubMed Central

    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. PMID:23864956

  1. 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

    ... HUMAN SERVICES Meeting of the Advisory Committee on Blood and Tissue Safety and Availability AGENCY... of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue... Executive Secretary ACBTSA, Division of Blood and Tissue Safety and Availability, Office of HIV/AIDS...

  2. 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…

  3. Preoperative Autologous Blood Donation: Waning Indications in an Era of Improved Blood Safety.

    PubMed

    Vassallo, Ralph; Goldman, Mindy; Germain, Marc; Lozano, Miguel

    2015-10-01

    A downward trend in preoperative autologous donation (PAD) continues in Europe and the Americas, with many jurisdictions only funding medically necessary collections at present. This is the result of decreasing real and perceived residual risks of allogeneic transfusion-transmitted disease and the declining need for transfusion due to patient blood management, which have also led to escalating logistical and cost constraints for PAD programs. We outline collection trends in North America, Europe, and Latin America and review the benefits, risks, effectiveness, and safety of PAD. Important elements of informed consent follow from these points. Evidence-based medical criteria for PAD and autologous transfusion are discussed as are methods to optimize autologous collection timing to regenerate donated red cells. Recommendations for identification of patients whose risk-to-benefit ratio suggests substantial benefit compared with other autologous blood salvage and anemia management alternatives conclude the review. PMID:26006319

  4. 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

  5. [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. PMID:22043595

  6. 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. PMID:26653169

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

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... improperly designed human-machine interface; installation and maintenance errors; and errors associated with... Applications: Specification and Demonstration of Reliability, Availability, Maintainability and Safety...

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

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    .... The product design must sufficiently incorporate human factors engineering that is appropriate to the... principles when designing and demonstrating the safety of products covered by subpart H or I of this part. In... associated with the design principle not followed. (1) System safety under normal operating conditions....

  9. 49 CFR Appendix C to Part 236 - Safety Assurance Criteria and Processes

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... results of system safety analyses provided in the RSPP, PSP, PTCIP, PTCDP, and PTCSP documents as appropriate. An analysis performed under this appendix must: (1) Address each of the safety principles of... system operation. Hazards categorized as unacceptable, which are determined by hazard analysis, must...

  10. Targeting of blood safety measures to affected areas with ongoing local transmission of malaria.

    PubMed

    Domanović, D; Kitchen, A; Politis, C; Panagiotopoulos, T; Bluemel, J; Van Bortel, W; Overbosch, D; Lieshout-Krikke, R; Fabra, C; Facco, G; Zeller, H

    2016-06-01

    An outbreak of locally acquired Plasmodium vivax malaria in Greece started in 2009 and peaked in 2011. Targeting of blood safety measures to affected areas with ongoing transmission of malaria raised questions of how to define spatial boundaries of such an area and when to trigger any specific blood safety measures, including whether and which blood donation screening strategy to apply. To provide scientific advice the European Centre for Disease Prevention and Control (ECDC) organised expert meetings in 2013. The outcomes of these consultations are expert opinions covering spatial targeting of blood safety measures to affected areas with ongoing local transmission of malaria and blood donation screening strategy for evidence of malaria infection in these areas. Opinions could help EU national blood safety authorities in developing a preventive strategy during malaria outbreaks. PMID:27238883

  11. Establishment and implementation of common product assurance and safety requirements for the contractors of the Columbus programme

    NASA Astrophysics Data System (ADS)

    Wessels, H.; Stephan, H. J.

    1991-08-01

    When establishing the Columbus Product Assurance (PA)/safety requirements, the international environment of the Space Station Freedom program has to be taken into account. Considerations given to multiple ways of requirement definition and stages within the European Space Agency (ESA) Procedures, Specifications, and Standards (PSS-01) series of documents and the NASA Space Station requirements are discussed. A series of adaptations introduced by way of tailoring the basic ESA and NASA requirement sets to the Columbus program's needs are described. For the implementation of these tailored requirements, a scheme is developed, which recognizes the PA/safety approach within the European industries by way of various company handbooks and manuals. The changes introduced in the PSS-01 series and the applicable NASA Space Station requirements in recent years, has coincided with the establishment of Columbus PA/safety requirements. To achieve the necessary level of cooperation between ESA and the Columbus industries, a PA Working Group (PAWG) is established. The PAWG supervises the establishement of the Common PA/Safety Plan and the Standards to be used. Due to the high number of European industries participating in the Columbus program, a positive influence on the evolution of the industrial approaches in PA/safety can be expected. Cooperation in the PAWG has brought issues to light which are related to the ESA PSS-01 series and its requirements. Due to the rapid changes of recent years, basic company documentation has not followed the development, specifically as various recent ESA projects use different project specifc issues of the evolving PSS-01 documents.

  12. 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. PMID:24389794

  13. 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.

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

    PubMed Central

    Shrivastava, Manisha; Shah, Nehal; Navaid, Seema; Agarwal, Kalpana; Sharma, Gourav

    2016-01-01

    Context: Blood donor selection criteria based on science and regulatory rules influence donor as well recipient safety and demographics. Aim: To evaluate and analyze the blood donor deferral pattern and its causes among blood donors in a tertiary care hospital blood bank and to review its influence on blood safety. Settings and Design: Hospital based blood bank, retrospective analysis. Subjects and Methods: The data available as donor deferral record over a period of 13 years from 2001 to 2013 was analyzed. Results: The blood donor deferral rate was 11.5%, the deferral rate in various categories was 4.8%, 4.7%, 1.6%, and 0.3% in Category 1, Category 2, Category 3, and Category 4, respectively. The majority of deferrals were temporary deferrals (62.8%) of young donors. The maximum number of donors deferred (28.2%) due to a history of jaundice (permanent) followed by 19.4% due to low hemoglobin (temporary). History of malaria, intake of medicines, infections, underweight, last blood donation within 3 months (temporary deferral), and history of heart and lung diseases, diabetes, and with suspicious identity (permanent deferral) were other major causes identified. Conclusion: The pattern of donor deferral identified is an important tool for blood safety and also provides key areas to focus on a region or policy formulation nationally for donor selection as well ensure donor safety. The value of determining donor deferral pattern by the categories described is in calling back donors deferred due to temporary reasons and can help retain pool of motivated blood donors. PMID:27605848

  15. 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

  16. 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. PMID:19025323

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

    SciTech Connect

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

    1985-01-01

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

  18. 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

  19. Current trends in safety assurance for tissue grafts used in burn treatment.

    PubMed

    Mericka, P

    2006-01-01

    The author presents a summary of current safety standards for allogeneic and xenogeneic biological skin grafts. The fundamental document relevant to allogeneic transplants, establishing the minimal level of safety guaranteed in European Union states, is the European Parliament and Council Directive (2004/23/EC) from March 31st 2004. This Directive determines that grafts will be prepared by a licensed or accredited tissue bank, and that this arrangement must be put in place by the member states within 2 years. In the Czech Republic licensing of tissue banks took place immediately after issuance of the Directive. Licensing was also a condition for product reimbursement by insurance companies. To gain a licence, tissue banks had to fulfil many safety criteria associated with screening of living or deceased donors for health suitability, providing traceability of the donor-recipient route, prevention of secondary and cross-contamination during processing and storage of the harvested tissues, proof of product microbiology check up, and cold chain control. The Tissue Bank of the Faculty Hospital in Hradec Králové is one of the two tissue banks that gained the broader type of 'multifunctional' licence and was granted registration number MTB 006. Obtaining the licence was facilitated by completion of a new workplace project conceived as a combination of cryogenic and clean-room technology. Currently, this tissue bank prepares cryopreserved dermoepidermal and dermal grafts as well as amnion and chorioamnion grafts. All tissue banks will have to renew their licences again according to the conditions established by a new law about human tissues and cells which is currently in preparation. Neither the Directive of the European Parliament nor the Transplantation Law of the Czech Republic regulates the issue of xenografts. Since availability of allogeneic biological covers is limited, it is significant that the WHO perspective on the use of xenogeneic biological covers, as

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

    PubMed

    Khan, Ikhlas A; Smillie, Troy

    2012-09-28

    Natural products have provided a basis for health care and medicine to humankind since the beginning of civilization. According to the World Health Organization (WHO), approximately 80% of the world population still relies on herbal medicines for health-related benefits. In the United States, over 42% of the population claimed to have used botanical dietary supplements to either augment their current diet or to "treat" or "prevent" a particular health-related issue. This has led to the development of a burgeoning industry in the U.S. ($4.8 billion per year in 2008) to supply dietary supplements to the consumer. However, many commercial botanical products are poorly defined scientifically, and the consumer must take it on faith that the supplement they are ingesting is an accurate representation of what is listed on the label, and that it contains the purportedly "active" constituents they seek. Many dietary supplement manufacturers, academic research groups, and governmental organizations are progressively attempting to construct a better scientific understanding of natural products, herbals, and botanical dietary supplements that have co-evolved with Western-style pharmaceutical medicines. However, a deficiency of knowledge is still evident, and this issue needs to be addressed in order to achieve a significant level of safety, efficacy, and quality for commercial natural products. The authors contend that a "quality by design" approach for botanical dietary supplements should be implemented in order to ensure the safety and integrity of these products. Initiating this approach with the authentication of the starting plant material is an essential first step, and in this review several techniques that can aid in this endeavor are outlined. PMID:22938174

  1. 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

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

    PubMed

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

    2015-09-10

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

  3. 76 FR 26300 - Meeting of the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-06

    ... asked to review the WHA 63.22 on human organ and tissue transplantation and if appropriate, make.... James Berger, Associate Public Health Advisor for Blood, Organ and Tissue Safety, Office of the... and legal issues related to transfusion, and transplantation safety, and (3) the implications...

  4. 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.

  5. 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.

  6. 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.

  7. Verification test problems for the calculation of 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 (Arizona State University, Tempe, AZ)

    2006-06-01

    Four verification test problems are presented for checking the conceptual development and computational implementation of calculations to determine the probability of loss of assured safety (PLOAS) in temperature-dependent systems with multiple weak links (WLs) and strong links (SLs). The problems are designed to test results obtained with the following definitions of loss of assured safety: (1) Failure of all SLs before failure of any WL, (2) Failure of any SL before failure of any WL, (3) Failure of all SLs before failure of all WLs, and (4) Failure of any SL before failure of all WLs. The test problems are based on assuming the same failure properties for all links, which results in problems that have the desirable properties of fully exercising the numerical integration procedures required in the evaluation of PLOAS and also possessing simple algebraic representations for PLOAS that can be used for verification of the analysis.

  8. 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).

  9. 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

  10. [The virological safety and bacterial sterility of a method for fractionating blood plasma proteins with rivanol].

    PubMed

    Zhurina, N A; Shatskaia, T L; Katushkina, N V

    1993-01-01

    The bacterial and virological safety of the method of rivanol fractionation of blood plasma proteins has been evaluated in experiments with samples of donor blood plasma mixed with the suspension of viruses and Escherichia coli used as models. The bacteriostatic action of rivanol and the elimination of bacteriophage and influenza virus from the end product at the stages of rivanol precipitation and adsorption on carbon have been established. PMID:8067072

  11. 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.

  12. 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.

  13. 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

  14. Blood donation in China: sustaining efforts and challenges in achieving safety and availability.

    PubMed

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

    2015-10-01

    China has entered a new phase in blood safety and availability through persistent efforts in the past decades. Based on national data from 2008 to 2012, we present a comprehensive review on the blood services ranging from policy and organization, supply, donors, screening and processing, and clinical use to government response in contemporary China. Current evidence suggests that the Chinese blood industries, after continual efforts in reforms on the legal framework and national management system, have been in a relatively steady but bottleneck stage. Although the blood industries have had an impressive track record on management and resolving problems, such as low availability, limited donors, deficient laboratory tests, shortage of blood products, and unnecessary clinical usage of blood still exist nationwide. While medical technology and services have seen a rapid increase in progress in recent years, they have not coordinated with the development of the national health care system. This article presents an analysis with detailed data, rich contents, and recent response from the Chinese government, allowing readers to appreciate how China, a country with more than 19.13% of the world's population, has long endeavored to improve safety and availability of blood. Meantime, the article sincerely welcomes the guidance on policymaking and technical assistance from the international community. Data in this article do not include those of Hong Kong, Macao, or Taiwan. PMID:26111254

  15. 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

    ...As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a meeting. The meeting will be open to the...

  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. Blood conservation strategies in major orthopaedic surgery: efficacy, safety and European regulations.

    PubMed

    Muñoz, M; García-Erce, J A; Villar, I; Thomas, D

    2009-01-01

    Several major orthopaedic surgical procedures may result in significant blood loss and the need for allogeneic blood transfusion (ABT). However, overall concerns about adverse effects of ABT have prompted the review of transfusion practice and the search for transfusion alternatives to decrease or avoid the use of ABT. These strategies include the correction of perioperative anaemia, pharmacological and non-pharmacologic measures to reduce blood loss, preoperative autologous blood donation and perioperative red blood cell salvage. We have reviewed the efficacy and safety of these strategies and where appropriate offer evidence-based recommendations on their use in orthopaedic surgery. We also reviewed the European regulations on ABT alternatives. Pharmacological alternatives need to be used with a total adherence to European regulations in their legal and off-label use. The administration and use of pharmacological agents to stimulate erythropoiesis or reduce blood loss needs to be within the context of attempting to use allogenic blood in a rational manner. As for autologous blood, European Directives cover preoperative autologous blood donation, but not its clinical use, and perioperative red blood cell salvage devices, but not the product yielded by them. Therefore, the development of quality standards and good practice guidelines for perioperative red blood cell salvage, as well as its inclusion in the haemovigilance programme, is urgently needed. Finally, it is noteworthy that some recommendations given for ABT alternatives are not supported by a high level of evidence and that the goal of performing major orthopaedic surgical procedures without the use of ABT may be better accomplished by combining several of these techniques within a defined algorithm. PMID:19121192

  18. 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.

  19. Safety of the blood supply in a rural area of China

    PubMed Central

    Liu, Shusen; Figueroa, Priscilla; Rou, Keming; Wu, Zunyou; Chen, Xi; Detels, Roger

    2010-01-01

    OBJECTIVE To determine the sensitivity and specificity of tests for HBsAg, HCV, and syphilis conducted by laboratories of three blood collection organizations in a rural area of China. METHODS From October to December 2003, 1068 samples were collected from blood donors presenting to the three collection centers. All samples were tested twice using two different test kits for HBsAg, HCV, and syphilis. An aliquot was sent to the China National Center for Clinical Laboratories (NCCL) to confirm the local test results. Sensitivities and specificities of the three local blood centers/banks were calculated, using the results of the NCCL as the gold standard. RESULTS The sensitivity of the three blood collection center/banks ranged from 0% to 63.2% for HBsAg. For HCV, the sensitivity was 0%, and for syphilis, ranged from 0% to 85.7%. There were no HBsAg-positives in one of the blood center/banks, and no syphilis-positives in the other. Thus, sensitivity could not be measured for these tests in these two facilities. Combining all three tests, the overall sensitivity was 55.6%. The specificity was 100%. CONCLUSION The sensitivity of the local laboratories was inadequate, and could cause possible infection for an unacceptable number of blood recipients. Action needs to be taken to improve the quality of testing to ensure the safety of the rural blood supply. PMID:20104105

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

    SciTech Connect

    Johnson, J. D.; Oberkampf, William Louis; Helton, Jon Craig

    2007-05-01

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

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

    PubMed Central

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

    2015-01-01

    Background Prolonged or excessive blood loss is a common complication after cardiac surgery. Blood remnants and clots, remaining in the pericardial space in spite of chest tube drainage, induce high fibrinolytic activity that may contribute to bleeding complications. Continuous postoperative pericardial flushing (CPPF) with an irrigation solution may reduce blood loss by preventing the accumulation of clots. In this pilot study, the safety and feasibility of CPPF were evaluated and the effect on blood loss and other related complications was investigated. Methods Between November 2011 and April 2012 twenty-one adult patients undergoing surgery for congenital heart disease (CHD) received CPPF from sternal closure up to 12 h postoperative. With an inflow Redivac drain that was inserted through one of the chest tube incision holes, an irrigation solution (NaCl 0.9% at 38 °C) was delivered to the pericardial cavity using a volume controlled flushing system. Safety aspects, feasibility issues and complications were registered. The mean actual blood loss in the CPPF group was compared to the mean of a retrospective group (n = 126). Results CPPF was successfully completed in 20 (95.2%) patients, and no method related complications were observed. Feasibility was good in this experimental setting. Patients receiving CPPF showed a 30% (P = 0.038) decrease in mean actual blood loss 12 h postoperatively. Conclusions CPPF after cardiac surgery was found to be safe and feasible in this experimental setting. The clinically relevant effect on blood loss needs to be confirmed in a randomized clinical trial. PMID:26501121

  2. 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.

  3. Producer quality assurance programs.

    PubMed

    Kla, J; Tollefson, L

    1999-03-01

    Essentially all animal commodity organizations have established quality assurance programs designed to ensure food safety and quality. Most of these programs were originally implemented to address problems with veterinary drug residues. Many of the current programs have or plan to include food safety critical control points with specific guidelines on how to control or reduce pathogen load. The continued focus placed on food safety by today's consumer demands that American producers ensure that their commodities are wholesome, safe, and of high quality in order to remain competitive in the global marketplace. Veterinarians should recognize that it is important to encourage food animal producers to participate in quality assurance programs for their clients' economic health and for food safety and protection of public health. Commodities certified as being produced under good production practices or by producers certified as following a recognized and validated quality assurance program often bring a premium price. Also, some slaughter establishments are beginning to require producers to be certified as practicing under a recognized quality assurance program before animals are accepted for processing. This practice is being driven partially by the demands placed on slaughter establishments by the US Department of Agriculture's implementation of the Pathogen Reduction, Hazard Analysis and Critical Control Point Systems regulation. Regardless of why producer trade association quality assurance programs have come into existence, veterinarians should promote the programs as an excellent mechanism to help ensure everyone's goal of a safe, wholesome food supply. PMID:10088219

  4. 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

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

    PubMed

    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

  6. Blood

    MedlinePlus

    ... solid part of your blood contains red blood cells, white blood cells, and platelets. Red blood cells (RBC) deliver oxygen from your lungs to your tissues and organs. White blood cells (WBC) fight infection and are part of your ...

  7. 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.

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

    PubMed

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

    2014-03-01

    The Retrovirus Epidemiology Donor Study (REDS) program was established in the United States in 1989 with the purpose of increasing blood transfusion safety in the context of the HIV/AIDS and human T-lymphotropic virus epidemics. REDS and its successor, REDS-II were at first conducted in the US, then expanded in 2006 to include international partnerships with Brazil and China. In 2011, a third wave of REDS renamed the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) was launched. This seven-year research program focuses on both blood banking and transfusion medicine research in the United States of America, Brazil, China, and South Africa. The main goal of the international programs is to reduce and prevent the transmission of HIV/AIDS and other known and emerging infectious agents through transfusion, and to address research questions aimed at understanding global issues related to the availability of safe blood. This article describes the contribution of REDS-II to transfusion safety in Brazil. Articles published from 2010 to 2013 are summarized, including database analyses to characterize blood donors, deferral rates, and prevalence, incidence and residual risk of the main blood-borne infections. Specific studies were developed to understand donor motivation, the impact of the deferral questions, risk factors and molecular surveillance among HIV-positive donors, and the natural history of Chagas disease. The purpose of this review is to disseminate the acquired knowledge and briefly summarize the findings of the REDS-II studies conducted in Brazil as well as to introduce the scope of the REDS-III program that is now in progress and will continue through 2018. PMID:24790542

  9. 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

  10. Healthcare software assurance.

    PubMed

    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

  11. 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. PMID:26183121

  12. Safety and Patient Acceptability of Stellate Ganglion Blockade as a Treatment Adjunct for Combat-Related Post-Traumatic Stress Disorder: A Quality Assurance Initiative

    PubMed Central

    2015-01-01

    OBJECTIVE: To perform a quality assurance and performance improvement project through review of our single center data on the safety and patient acceptability of the stellate ganglion blockade (SGB) procedure for the relief of symptoms related to chronic post-traumatic stress disorder. BACKGROUND: Our interventional pain management service has been offering trials of SGB therapy to assist with the management of the sympathetically mediated anxiety and hyperarousal symptoms of severe and treatment-refractory combat-related PTSD. There have been multiple case series in the literature describing the potential impact of this procedure for PTSD symptom management as well as the safety of image-guided procedures. We wished to ensure that we were performing this procedure safely and that patients were tolerating and accepting of this adjunctive treatment option. METHODS: We conducted a review of our quality assurance and performance improvement data over the past 18 months during which we performed 250 stellate ganglion blocks for the management of PTSD symptoms to detect any potential complications or unanticipated side effects.  We also analyzed responses from an anonymous patient de-identified survey collected regarding the comfort and satisfaction associated with the procedure. RESULTS: We did not identify any immediate post-procedural complications or delayed complications from any of the 250 procedures performed from November 2013 to April 2015. Of the 110 surveys that were returned and tabulated, 100% of the patients surveyed were overall satisfied with our process and with the procedure, 100% said they would recommend the procedure to a friend, and 95% stated that they would be willing to undergo as many repeat procedures as necessary based on little discomfort and tolerable side effects. CONCLUSION: Our quality assurance assessment suggests that in our center the SGB procedure for PTSD is a safe, well-tolerated, and acceptable

  13. 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.

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

    PubMed

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

    2016-01-01

    Whole body plethysmography using unrestrained animals is a common technique for assessing the respiratory risk of new drugs in safety pharmacology studies in rats. However, wide variations in experimental technique make cross laboratory comparison of data difficult and raise concerns that non-appropriate conditions may mask the deleterious effects of test compounds - in particular with suspected respiratory depressants. Therefore, the objective of this study was to evaluate the robustness of arterial blood gas analysis as an alternative to plethysmography in rats. We sought to do this by assessing the effect of different vehicles and times post-surgical catheterization on blood gas measurements, in addition to determining sensitivity to multiple opioids. Furthermore, we determined intra-lab variability from multiple datasets utilizing morphine and generated within a single lab and lastly, inter-lab variability was measured by comparing datasets generated in two separate labs. Overall, our data show that arterial blood gas analysis is a measure that is both flexible in terms of experimental conditions and highly sensitive to respiratory depressants, two key limitations when using plethysmography. As such, our data strongly advocate the adoption of arterial blood gas analysis as an investigative approach to reliably examine the respiratory depressant effects of opioids. PMID:26589431

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

    PubMed

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

    1990-05-01

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

  16. 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…

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

    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.

  18. 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.

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

    PubMed Central

    Cheung, Tommy Tsang; Cheung, Bernard Man Yung

    2014-01-01

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

  20. 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.

  1. [Reorganization of blood watch and transfusion safety activities in the Marseille public hospital system in partnership between the French Blood Institute Alps Mediterranean Division (EFS AM)].

    PubMed

    Lassale, B; Legrand, D; Chiaroni, J

    2010-02-01

    The Marseille public hospital system (APHM) has expressed its willingness to pool its services of immunohematology and delivery of labile blood products with those of the French blood institute Alps Mediterranean division (EFS AM). An agreement setting out the terms of this partnership was signed between the two parties. The users of the APHM and EFS AM blood watch wished to preserve the channels of distribution. Implementation of this reorganization has focused on ensuring transfusional safety, reinforcing harmonization of APHM practices, and finding ways to reduce costs. Despite joint information campaigns (to medical and paramedical personnel) carried out by the APHM and EFS AM blood watch, problems have arisen during start-up and adjustments have been necessary on both sides. The success of this project hinges on the involvement of the EFS AM in our transfusional practices, deployment of a system for diffusion of information, and consolidation of physical and human resources at the level of the APHM blood watch. PMID:20106701

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

    PubMed

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

    2013-05-01

    Bispecific antibodies using the transferrin receptor (TfR) have shown promise for boosting antibody uptake in brain. Nevertheless, there are limited data on the therapeutic properties including safety liabilities that will enable successful development of TfR-based therapeutics. We evaluate TfR/BACE1 bispecific antibody variants in mouse and show that reducing TfR binding affinity improves not only brain uptake but also peripheral exposure and the safety profile of these antibodies. We identify and seek to address liabilities of targeting TfR with antibodies, namely, acute clinical signs and decreased circulating reticulocytes observed after dosing. By eliminating Fc effector function, we ameliorated the acute clinical signs and partially rescued a reduction in reticulocytes. Furthermore, we show that complement mediates a residual decrease in reticulocytes observed after Fc effector function is eliminated. These data raise important safety concerns and potential mitigation strategies for the development of TfR-based therapies that are designed to cross the blood-brain barrier. PMID:23636093

  3. 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. PMID:19894488

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. Blood

    MedlinePlus

    ... fight infection and are part of your body's defense system. Platelets help blood to clot when you have a cut or wound. Bone marrow, the spongy material inside your bones, makes new blood cells. Blood cells ...

  10. 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

  11. 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.

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

    PubMed

    Abdullah, Saleh; Karunamoorthi, Kaliyaperumal

    2016-01-01

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

  13. 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. PMID:16820341

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

    PubMed

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

    2014-06-01

    The current issues debate brings together experts around the themes of self-sufficiency (in its national and European aspects) and of needs in cellular blood products. The point of view of the manufacturer and prescribers of blood products are confronted. PMID:24906893

  15. 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.

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

    PubMed Central

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

    2014-01-01

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

  17. 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

  18. A Model-Based Product Evaluation Protocol for Comparison of Safety-Engineered Protection Mechanisms of Winged Blood Collection Needles.

    PubMed

    Haupt, C; Spaeth, J; Ahne, T; Goebel, U; Steinmann, D

    2016-05-01

    OBJECTIVE To evaluate differences in product characteristics and user preferences of safety-engineered protection mechanisms of winged blood collection needles. DESIGN Randomized model-based simulation study. SETTING University medical center. PARTICIPANTS A total of 33 third-year medical students. METHODS Venipuncture was performed using winged blood collection needles with 4 different safety mechanisms: (a) Venofix Safety, (b) BD Vacutainer Push Button, (c) Safety-Multifly, and (d) Surshield Surflo. Each needle type was used in 3 consecutive tries: there was an uninstructed first handling, then instructions were given according to the operating manual; subsequently, a first trial and second trial were conducted. Study end points included successful activation, activation time, single-handed activation, correct activation, possible risk of needlestick injury, possibility of deactivation, and preferred safety mechanism. RESULTS The overall successful activation rate during the second trial was equal for all 4 devices (94%-100%). Median activation time was (a) 7 s, (b) 2 s, (c) 9 s, and (d) 7 s. Single-handed activation during the second trial was (a) 18%, (b) 82%, (c) 15%, and (d) 45%. Correct activation during the second trial was (a) 3%, (b) 64%, (c) 15%, and (d) 39%. Possible risk of needlestick injury during the second trial was highest with (d). Possibility of deactivation was (a) 0%, (b) 12%, (c) 9%, and (d) 18%. Individual preferences for each system were (a) 11, (b) 17, (c) 5, and (d) 0. The main reason for preference was the comprehensive safety mechanism. CONCLUSION Significant differences exist between safety mechanisms of winged blood collection needles. Infect Control Hosp Epidemiol 2016;37:505-511. PMID:26868306

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

    PubMed

    Liras, Antonio

    2008-01-01

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

  20. Blood Frequently Asked Questions

    MedlinePlus

    ... manufacturers commonly produce these blood products. Top What fees are associated with blood? While donated blood is ... donors; and quality assurance. As a result, processing fees are charged to recover costs. Processing fees for ...

  1. 10 CFR 830.122 - Quality assurance criteria.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.122 Quality assurance criteria. The QAP must address the following management, performance, and assessment criteria: (a) Criterion 1—Management/Program. (1) Establish an organizational structure, functional...

  2. 10 CFR 830.122 - Quality assurance criteria.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.122 Quality assurance criteria. The QAP must address the following management, performance, and assessment criteria: (a) Criterion 1—Management/Program. (1) Establish an organizational structure, functional...

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

    PubMed

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

    2016-02-01

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

  4. Antibodies to Leptospira among blood donors in higher-risk areas of Australia: possible implications for transfusion safety

    PubMed Central

    Faddy, Helen; Seed, Clive; Lau, Colleen; Racloz, Vanessa; Flower, Robert; Smythe, Lee; Burns, Mary-Anne; Dohnt, Michael; Craig, Scott; Harley, Robert; Weinstein, Philip

    2015-01-01

    Background Leptospirosis is one of the most common bacterial zoonoses worldwide, and clinical manifestations range from asymptomatic infection to acute febrile illness, multi-organ failure and death. Asymptomatic, acute bacteraemia in a blood donor provides a potential for transfusion-transmission, although only a single such case from India has been recorded. Human leptospirosis is uncommon in developed countries; however, the state of Queensland in Australia has one of the highest rates among developed countries, especially after increased rainfall. This study examined the prevalence of antibodies to Leptospira spp. in blood donors residing in higher-risk areas of Australia, to evaluate the appropriateness of current blood safety guidelines. Materials and methods Plasma samples collected from blood donors residing in higher-risk areas of Australia during 2009 and 2011 were included in the study. All samples were tested for the presence of antibodies to 22 leptospiral serovars using the microscopic agglutination test. Result No sample had antibody titres suggestive of a current or recent infection, however, seven samples (1.44%, 95% CI: 0.38–2.50%) had titres suggestive of a past infection. Discussion This study provides data that may support the appropriateness of current relevant donor selection policies in Australia. Given that the risk profile for leptospirosis is expanding and that the infection is likely to become more prevalent with climate change, this disease may become more of a concern for transfusion safety in the future. PMID:24960651

  5. 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...

  6. 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...

  7. 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...

  8. 30 CFR 14.8 - Quality assurance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality assurance. 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)...

  9. 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...

  10. Healthy Family 2009: Assuring Healthy Aging

    MedlinePlus

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

  11. 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

  12. Blood transfusion safety: A study of adverse reactions at the blood bank of a tertiary care center

    PubMed Central

    Negi, Gita; Gaur, Dushyant Singh; Kaur, Rajveer

    2015-01-01

    Background: An adverse transfusion reaction (ATR) is an unfavorable reaction to the transfused unit, the severity of which may be different among individuals depending upon the type of reaction and the patient's susceptibility. Transfusion reactions may be immediate or delayed type depending on the onset and immune or nonimmune type depending on the pathogenesis. A study was conducted to study the frequency of various transfusion reactions and the associated morbidity. Materials and Methods: All ATRs occurring over a period of 3 years at a tertiary care health center were studied in detail according to the institute's protocol. Results: Of 38,013 units of blood and components that had been issued, 101 (0.2%) cases had an ATR. The most common reaction was allergic - 34/101 (33.6%) followed by febrile - 26/101 (25.7%). Other reactions included transfusion-related acute lung injury in 6/101 (5.9%) cases, and immune reactions were seen in 19/101 (18.8%) cases. Conclusion: Allergic and febrile reactions are most common and least harmful, but fatal reactions can also occur, and preventive measures must be taken to avoid such reactions. PMID:26682203

  13. Effect of Safety Measures on Bacterial Contamination Rates of Blood Components in Germany

    PubMed Central

    Walther-Wenke, Gabriele; Däubener, Walter; Heiden, Margarethe; Hoch, Jochen; Hornei, Britt; Volkers, Peter; von König, Carl Heinz Wirsing

    2011-01-01

    Summary Requirements for bacterial testing of blood components on a defined quantity as part of routine quality control were introduced in Germany by the National Advisory Committee Blood of the German Federal Ministry of Health in 1997. The philosophy was to establish standardized methods for bacterial testing. Numerous measures to reduce the risk of bacterial contamination were implemented into the blood donation and manufacturing processes between 1999 and 2002. German Blood establishments performed culture-based bacterial testing on random samples of platelet concentrates (PCs), red blood cells (RBCs) and fresh frozen plasma (FFP) and reported data out of the production periods 1998, 2001 and 2005/2006. While the bacterial contamination rate of apheresis PCs remained nearly unchanged, it decreased by 70% for pooled PCs to a rate of 0.158% in the last observation period. Leukocyte-depleted RBCs with diversion of the initial blood volume showed a contamination rate of 0.029% which is significantly lower than that of RBCs without leukocyte depletion and diversion (0.157%). The contamination rate of plasma decreased by 80%. Preventive measures resulted in a significant reduction of bacterial contamination of blood components. Long-term monitoring with standardized methods for bacteria testing supports evaluation of the cumulative effect of contamination reducing measures. PMID:22016691

  14. 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

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

    PubMed

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

    2007-01-01

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

  16. 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.

  17. Quality assurance program plan for Building 324

    SciTech Connect

    Tanke, J.M.

    1997-05-22

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

  18. College Quality Assurance Assurances. Mendip Papers 020.

    ERIC Educational Resources Information Center

    Sallis, E.; Hingley, P.

    This paper discusses the increasing interest in quality assurance in British education including its measurement and management through the introduction of a quality assurance system. The reasons and benefits of beginning a quality assurance system are discussed, and questions of what constitutes quality, whether it is quality in fact…

  19. 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... the Quality Assurance criteria in § 830.122. (b) The contractor responsible for a DOE nuclear...

  20. 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...

  1. 10 CFR 830.122 - Quality assurance criteria.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Quality assurance criteria. 830.122 Section 830.122 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.122 Quality assurance...) Criterion 1—Management/Program. (1) Establish an organizational structure, functional...

  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. 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...

  4. 49 CFR 180.505 - Quality assurance program.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 3 2012-10-01 2012-10-01 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...

  5. 49 CFR 180.505 - Quality assurance program.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 3 2013-10-01 2013-10-01 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. 75 FR 28619 - Meeting of the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-21

    ... blood supply as well as the theoretical risk of emerging infectious disease (EID) transmission. FDA has... subgroups, including those whose sex partners have risk behavior(s) associated with a higher prevalence...

  7. 78 FR 66006 - Meeting of the Advisory Committee on Blood and Tissue Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-04

    ..., (2) broad public health, ethical, and legal issues related to transfusion and transplantation safety... Transplantation. The public will have the opportunity to present their views to the Committee during a...

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

    PubMed

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

    2016-02-01

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

  9. 23 CFR Appendix A to Part 1200 - Certification and Assurances for Highway Safety Grants (23 U.S.C. Chapter 4)

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... prohibits discrimination on the basis of disabilities (and 49 CFR Part 27); (d) the Age Discrimination Act..., including but not limited to: • 23 U.S.C. Chapter 4—Highway Safety Act of 1966, as amended • 49 CFR Part 18... • 23 CFR Part 1200—Uniform Procedures for State Highway Safety Grant Programs The State has...

  10. 23 CFR Appendix A to Part 1200 - CERTIFICATION AND ASSURANCES FOR HIGHWAY SAFETY GRANTS (23 U.S.C. CHAPTER 4)

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... prohibits discrimination on the basis of disabilities (and 49 CFR Part 27); (d) the Age Discrimination Act..., including but not limited to: • 23 U.S.C. Chapter 4—Highway Safety Act of 1966, as amended • 49 CFR Part 18... • 23 CFR Part 1200—Uniform Procedures for State Highway Safety Grant Programs The State has...

  11. Blood safety: Opportunities and challenges addressed through Critical Path research at FDA.

    PubMed

    Atreya, Chintamani D; Epstein, Jay S

    2007-01-01

    New scientific discoveries and technologies create opportunities for medical and public health advancement through development of innovative products. However, novel products and technologies bring new challenges to regulation. FDA recently established a 'Critical Path' research initiative to modernize regulatory science concepts and tools to meet the challenges of the 21st century. Central to this initiative is the concept that regulatory science is distinct from the 'discovery' science that generates ideas for development of new drugs, biologics, or medical devices. In this article, the authors discuss the concepts of FDA 'Critical Path' research and review examples of such research performed in the Office of Blood Research and Review within the Center for Biologics Research and Evaluation at FDA to illustrate how the 'Critical Path' research is being used to address opportunities and challenges impacting blood and blood products.: PMID:24980841

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

    ClinicalTrials.gov

    2016-04-08

    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

  13. 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. PMID:1286566

  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. 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. PMID:26847866

  16. 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

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

    PubMed

    Johnson, Andrew D; Cohn, Claudia S

    2016-10-01

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

  18. 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.

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

    PubMed

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

    2012-10-01

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

  20. 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)

  1. [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. PMID:26762688

  2. The NHLBI Retrovirus Epidemiology Donor Studies (REDS and REDS-II): Twenty years of research to advance blood product safety and availability

    PubMed Central

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

    2012-01-01

    The Retrovirus Epidemiology Donor Study (REDS), conducted from 1989–2001, and the Retrovirus Epidemiology Donor Study-II (REDS-II), conducted from 2004–2012, were National Heart Lung and Blood Institute (NHLBI) funded multicenter programs focused on improving blood safety and availability in the United States. REDS-II also included international study sites in Brazil and China. The three major research domains of REDS/REDS-II have been infectious disease risk evaluation, blood donation availability, and blood donor characterization. Both programs have made significant contributions to transfusion medicine research methodology by the use of mathematical modeling, large-scale donor surveys, innovative methods of repository sample storage, and establishing an infrastructure that responded to potential emerging blood safety threats such as XMRV. Blood safety studies have included protocols evaluating epidemiologic and/or laboratory aspects of HIV, HTLV I/II, HCV, HBV, WNV, CMV, HHV-8, B19V, malaria, CJD, influenza, and T. cruzi infections. Other analyses have characterized: blood donor demographics, motivations to donate, factors influencing donor return, behavioral risk factors, donors’ perception of the blood donation screening process, and aspects of donor deferral. In REDS-II, two large-scale blood donor protocols examined iron deficiency in donors and the prevalence of leukocyte antibodies. This review describes the major study results from over 150 peer-reviewed articles published by these two REDS programs. In 2011, a new seven year program, the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III), was launched. REDS-III expands beyond donor-based research to include studies of blood transfusion recipients in the hospital setting, and adds a third country, South Africa, to the international program. PMID:22633182

  3. 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.

  4. Rebuilding a safety culture

    NASA Technical Reports Server (NTRS)

    Rodney, George A.

    1991-01-01

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

  5. QUALITY ASSURANCE UPDATE

    EPA Science Inventory

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

  6. Quality Assurance Project Plan

    SciTech Connect

    Holland, R. C.

    1998-06-01

    This Quality Assurance Project Plan documents the quality assurance activities for the Wastewater/Stormwater/Groundwater and Environmental Surveillance Programs. This QAPP was prepared in accordance with DOE guidance on compliance with 10CFR830.120.

  7. 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. PMID:25381805

  8. 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.

  9. 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.

  10. 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…

  11. Reliability assurance for regulation of advanced reactors

    SciTech Connect

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

    1991-01-01

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

  12. 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.

  13. Comprehensive drug screening in blood for detecting abused drugs or drugs potentially hazardous for traffic safety.

    PubMed

    Lillsunde, P; Michelson, L; Forsstrom, T; Korte, T; Schultz, E; Ariniemi, K; Portman, M; Sihvonen, M L; Seppala, T

    1996-02-01

    A comprehensive drug screening procedure for detecting drugs in the blood samples of car drivers suspected of driving under the influence of drugs, is presented. Amphetamines, cannabinoids, opioids, cocaine and benzodiazepines were screened by an immunological EMIT ETS system after acetone precipitation. Gas chromatographic methods were used to screen and quantitate basic, neutral and acidic drugs. The free amino groups of basic drugs were derivatized with heptafluorobutyric anhydride. Analysis was performed by a dual channel gas chromatograph combined with a nitrogen phosphorus and an electron capture detector. Phenyltrimethylammonium hydroxide was used as a methylathing agent for acidic substances before analysis with a gas chromatograph connected to a nitrogen phosphorus detector. A gas chromatograph/mass spectrometry was used as a common confirmation method. Tetrahydrocannabinol was quantitated after bis(trimethylsilyl)trifluoroacetamide derivatization, opiates after pentafluoropropionic anhydride derivatization and benzoylecgonine after pentafluoropropionic anhydride and pentafluoropropanol derivatization. Excluding benzodiazepines, which were confirmed with a gas chromatograph connected to a nitrogen phosphorus and an electron capture detector, the other basic drugs as well as the acidic drugs were confirmed after the same derivatization procedures as in the screening methods. Alcohols were quantitated in triplicate by gas chromatography using three different kinds of columns. Although urine is the most important specimen for screening abused drugs, it has only limited use in forensic toxicology. The described system is most useful for analyzing a wide range of substances, including illicit drugs, benzodiazepines, barbiturates, antidepressants and phenothiazenes in forensic samples when urine is not available. PMID:8819994

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

    PubMed

    Mallett, Lea H; Govande, Vinayak P; Shetty, Ashita; Beeram, Madhava R

    2016-04-01

    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. 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

  18. 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.

  19. 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…

  20. 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. PMID:23678729

  1. 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....

  2. 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....

  3. 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..., unless it is approved or rejected by DOE at an earlier date. (2) Modify the QAP as directed by DOE....

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

    PubMed

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

    2014-03-01

    There has been little blood safety research in sub-Saharan Africa, often consisting of local efforts whose findings had limited impact The "Francophone Africa Transfusion Research Network" was created in May 2007 with the objective of developing common evidence-based blood safety policies that may be adapted to each country's situation. The Group's activities to date have focused mainly on obtaining epidemiological and laboratory data on blood transfusion and on suggesting blood safety strategies, particularly in the field of TTIs. To carry out such research activities, the group works closely with the National Blood Transfusion Services (NBTS), the Regional Blood Transfusion Services (RBTS), the hospital blood banks (HBB) and collection stations. For the first 5years, four research priorities were identified: (i) descriptive studies of the characteristics of francophone African blood donors and blood centers; (ii) estimation of the residual risk of transfusion-transmitted major viral infections; (iii) an analysis of blood donor deferral strategies; and (iv) a description of TTI screening strategies and an external quality assurance system (EQAS) project. During this period, seven projects have been implemented at the national level and published and five multicenter studies were conducted and published. The present review reports the main observations and recommendations from those studies that could improve blood safety statute in Africa. PMID:24360798

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

    PubMed Central

    Kumar, Rajesh; Gupta, Sonia; Kaur, Amarjit; Gupta, Manvi

    2015-01-01

    Background: Transfusion-transmitted infections (TTIs) are one of the biggest threats to blood transfusion safety. Nucleic acid testing (NAT) in blood donor screening has been implemented in many countries to reduce the risk of TTIs. NAT shortens this window period, thereby offering blood centers a much higher sensitivity for detecting viral infections. Aims: The objective was to assess the role of individual donor-NAT (ID-NAT) for human immunodeficiency virus-1 (HIV-1), hepatitis C virus (HCV) and hepatitis B virus (HBV) and its role in blood safety. Materials and Methods: A total of 32978 donations were tested for all three viruses using enzyme-linked immuno-sorbent assay (Vironostika® HIV Ag-Ab, Hepanostika® HCV ultra and hepatitis B surface antigen ultra by Biomerieux) and ID-NAT using Procleix Ultrio plus® Assay (Novartis Diagnostic, USA). All initial NAT reactive samples and serology nonreactive were retested in triplicate and NAT discriminatory assay for HIV-1, HCV and HBV were performed. Results: Of the 32978 samples, 43 (0.13%) were found to be ID-NAT reactive but seronegative. Out of 43, one for HIV-1, 13 for HCV and 27 for HBV were reactive by discriminatory assays. There were two samples that were reactive for both HCV-HBV and counted as HCV-HBV co-infection NAT yield. The prevalence of these viruses in our sample, tested by ID-NAT is 0.06%, 0.71%, and 0.63% for HIV-1, HCV and HBV respectively. The combined NAT yield among blood donors was 1 in 753. Conclusion: ID-NAT testing for HIV-1, HCV and HBV can tremendously improve the efficacy of screening for protecting blood recipient from TTIs. It enables detection of these viruses that were undetected by serological test and thus helped in providing safe blood to the patients. PMID:26420945

  6. 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.

  7. 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.

  8. Medical Device Safety

    MedlinePlus

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Medical Devices Home Medical Devices Medical Device Safety Medical Device Safety Share Tweet Linkedin Pin it More sharing ...

  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. 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).

  11. Quality Assurance Manual

    SciTech Connect

    McGarrah, J.E.

    1995-05-01

    In order to provide clients with quality products and services, Pacific Northwest Laboratory (PNL) has established and implemented a formal quality assurance program. These management controls are documented in this manual (PNL-MA-70) and its accompanying standards and procedures. The QA Program meets the basic requirements and supplements of ANSI/ASME NQA-1, Quality Assurance Program Requirements for Nuclear Facilities, as interpreted for PNL activities. Additional, the quality requirements are augmented to include the Total Quality approach defined in the Department of Energy Order 5700.6C, Quality Assurance. This manual provides requirements and an overview of the administrative procedures that apply to projects and activities.

  12. 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.

  13. Quality Assurance in Radiotherapy

    NASA Astrophysics Data System (ADS)

    Mckenzie, Alan

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

  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. 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.

  16. 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.

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

    PubMed Central

    2012-01-01

    Background In animal experiments, use of molecular hydrogen ( H2) has been regarded as quite safe and effective, showing benefits in multiple pathological conditions such as ischemia-reperfusion injury of the brain, heart, kidney and transplanted tissues, traumatic and surgical injury of the brain and spinal cord, inflammation of intestine and lung , degenerative striatonigral tissue and also in many other situations. However, since cerebral ischemia patients are in old age group, the safety information needs to be confirmed. For the feasibility of H2 treatment in these patients, delivery of H2 by inhalation method needs to be checked for consistency. Methods Hydrogen concentration (HC) in the arterial and venous blood was measured by gas chromatography on 3 patients, before, during and after 4% (case 1) and 3% (case2,3) H2 gas inhalation with simultaneous monitoring of physiological parameters. For a consistency study, HC in the venous blood of 10 patients were obtained on multiple occasions at the end of 30-min H2 inhalation treatment. Results The HC gradually reached a plateau level in 20 min after H2 inhalation in the blood, which was equivalent to the level reported by animal experiments. The HC rapidly decreased to 10% of the plateau level in about 6 min and 18 min in arterial and venous blood, respectively after H2 inhalation was discontinued. Physiological parameters on these 3 patients were essentially unchanged by use of hydrogen. The consistency study of 10 patients showed the HC at the end of 30-min inhalation treatment was quite variable but the inconsistency improved with more attention and encouragement. Conclusion H2 inhalation of at least 3% concentration for 30 min delivered enough HC, equivalent to the animal experiment levels, in the blood without compromising the safety. However, the consistency of H2 delivery by inhalation needs to be improved. PMID:22916706

  18. Pancreaticoduodenectomy using perioperative zymogen protein C to help prevent blood clotting: a trilogy on increased patient safety.

    PubMed

    Bruley, Duane F; Schulick, Richard D; Streiff, Michael B

    2013-01-01

    The blood clotting mechanism is a very important and complex physiologic process. Blood flow must be continuous through the blood vessels to provide essential oxygen and nutrients to the cells of the body. Dr. Melvin H. Knisely (Honorary First President of ISOTT, 1973) named and pioneered research in blood sludging and clotting which led to his nomination for the Nobel Prize by Dr. August Krogh in 1948. Abnormal clotting is a pathological state that can inhibit and prevent normal blood flow, leading to reduced oxygen transport to tissue from the microcirculation. It can result in the death of cells and tissues, including entire organs as well as the patient. Blood clotting and sludging are common occurrences during and after invasive surgery; thus, it is imperative to find safe procedures to reduce or prevent these deadly phenomena. All anticoagulants used today, for clot prevention and dissolution, can cause excessive bleeding that can lead to enormous medical expense to provide control, otherwise causing patient death. Protein C is a natural protein and is the pivotal anticoagulant in the blood. Due to the mechanism of converting the zymogen protein C (ZPC) to active protein C (APC), only when and where it is needed, and their respective half-lives in the body, the natural anticoagulant, antithrombotic characteristics of APC can be utilized without causing bleeds. PMID:23852508

  19. Quality Assurance: Patient Chart Reviews

    SciTech Connect

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

    2009-07-06

    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)

  20. 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. PMID:26609138

  1. 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.

  2. The limits of sterility assurance

    PubMed Central

    von Woedtke, Thomas; Kramer, Axel

    2008-01-01

    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

  3. 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

  4. Mission Operations Assurance

    NASA Technical Reports Server (NTRS)

    Faris, Grant

    2012-01-01

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

  5. Quality Assurance in Colleges.

    ERIC Educational Resources Information Center

    Dixon, Stella

    This document analyzes the inspection reports of the five further education (FE) colleges in Britain that have achieved a grade of 1 for quality assurance (QA), identifies key lessons for the improvement of programs in other FE colleges, and refers to helpful FE publications. The five colleges consisted of two general FE colleges, one sixth-form…

  6. 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…

  7. 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.

  8. 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.

  9. 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.

  10. Operating safety of automatic objects

    NASA Astrophysics Data System (ADS)

    Maiorov, Anatolii Vladimirovich; Moskatov, Genrikh Karlovich; Shibanov, Georgii Petrovich

    Operating-safety assurance for automatic objects (aircraft, spacecraft, and underwater vehicles) is considered in the framework of safety-automata theory and automatic-control considerations. The interaction between the operator and the safety-assurance facilities is considered. Methodological recommendations are presented on the specification of reliability requirements for the vehicles considered, as well as on automata synthesis and analysis considerations, test planning, and the analysis of test results.

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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.

  17. 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…

  18. 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 Teaching?" (Roger Ellis); (3)…

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

    PubMed Central

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

    2016-01-01

    Background: Red cell alloimmunization is an acknowledged complication of blood transfusion. Current transfusion practices for thalassemia do not cater to this risk. Serological phenotyping is usually not reliable in these cases unless performed before the first transfusion. Under such circumstances, molecular blood grouping is an effective alternative. Aim: To perform molecular blood group genotyping in chronically transfused thalassemia patients and assess the risk of antigenic exposure and incidence of alloimmunization with current transfusion protocols. Materials and Methods: Molecular blood group genotyping was performed for 47 chronically transfused thalassemia patients. Their 1-year transfusion records were retrieved to assess the antigenic exposure and the frequency thereof. Results: Of 47 patients, 6 were already alloimmunized (3 with anti-E and 3 with anti-K) and were receiving the corresponding antigen negative units. We observed that random selection of ABO and Rh D matched units resulted in 57.7% ±8.26% chance of Rh and Kell phenotype matching also. Forty-four patients had received one or more antigenic exposures at least once. The 6 already alloimmunized patients were further exposed to antigens other than the ones they were immunized to. During the study period, only one patient developed an alloantibody, anti-E with exposure to antigens C (92%) and/or E (32%) at each transfusion. Conclusion: Several factors apart from mere antigen exposure may influence the development of alloimmunization as most of our patients received antigenic exposures but not alloimmunized. Our data provide an impetus for future large-scale studies to understand the development of alloimmunization in such patients. PMID:27605852

  20. Blood lines conduct leakage current during haemodialysis: a potential safety risk during first failure, especially for patients with central dialysis catheter as access.

    PubMed

    Jonsson, P; Eliasson, G; Stegmayr, B G

    2005-11-01

    Haemodialysis (HD) machines are IEC-classified as I type B. When central dialysis catheters (CDCs) are used for access, there will be close electrical contact with the heart. To investigate the risk for HD patients, the leakage of current through the tubing set was measured during in vitro dialysis performed according to the IEC 60601-1 standard for class I cardiac floating (CF) devices. A series of eight measurements were made with Gambro GFS + 12 dialysers, first with saline and then with blood in the blood lines. The leakage current exceeded the CF limit (50 microA) at the top of the CDC using the test 'mains on applied part' for saline (median 1008 microA, range 720-1241 microA), for blood (median 610 microA, range 449-772 microA) and also for a 'single fault condition' using saline (median 68 microA, range 35-118 microA) or blood (47 microA, range 4-128 microA). In the single fault condition, the highest leakage current at the CDC (128 microA) almost exceeded the earth leakage current in normal conditions. A safety risk can appear if a single fault arises in the dialysis machine or another device connected to the same patient, or during 'mains contact to the patient'. Then the current flow may be high enough to induce arrhythmias in the patient, especially when a CDC is used. These data and the use of CDCs as access for dialysis indicate that HD machines should be classified as cardiac floating rather than body (B) devices. PMID:16594299

  1. 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.

  2. Helical tomotherapy quality assurance.

    PubMed

    Balog, John; Soisson, Emilie

    2008-01-01

    Helical tomotherapy uses a dynamic delivery in which the gantry, treatment couch, and multileaf collimator leaves are all in motion during treatment. This results in highly conformal radiotherapy, but the complexity of the delivery is partially hidden from the end-user because of the extensive integration and automation of the tomotherapy control systems. This presents a challenge to the medical physicist who is expected to be both a system user and an expert, capable of verifying relevant aspects of treatment delivery. A related issue is that a clinical tomotherapy planning system arrives at a customer's site already commissioned by the manufacturer, not by the clinical physicist. The clinical physicist and the manufacturer's representative verify the commissioning at the customer site before acceptance. Theoretically, treatment could begin immediately after acceptance. However, the clinical physicist is responsible for the safe and proper use of the machine. In addition, the therapists and radiation oncologists need to understand the important machine characteristics before treatment can proceed. Typically, treatment begins about 2 weeks after acceptance. This report presents an overview of the tomotherapy system. Helical tomotherapy has unique dosimetry characteristics, and some of those features are emphasized. The integrated treatment planning, delivery, and patient-plan quality assurance process is described. A quality assurance protocol is proposed, with an emphasis on what a clinical medical physicist could and should check. Additionally, aspects of a tomotherapy quality assurance program that could be checked automatically and remotely because of its inherent imaging system and integrated database are discussed. PMID:18406907

  3. Helical Tomotherapy Quality Assurance

    SciTech Connect

    Balog, John Soisson, Emilie

    2008-05-01

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

  4. 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.

  5. Short-Term Effects and Safety Analysis of Retrograde Autologous Blood Priming for Cardiopulmonary Bypass in Patients with Cardiac Valve Replacement Surgery.

    PubMed

    Cheng, Ming; Li, Jun-Quan; Wu, Tian-Chi; Tian, Wei-Chen

    2015-11-01

    This randomized, double-blind study evaluated the short-term effects and safety of perioperative retrograde autologous priming (RAP) for cardiopulmonary bypass (CPB) in patients with cardiac replacement surgery to determine if this approach is a better substitute for crystal liquids priming in patients with valvular heart disease. We observed that RAP significantly decreased the actual priming volume, preserved the hematocrit and hemoglobin level during CPB to a certain degree, and decreased lactate accumulation in CPB period. Moreover, RAP lowered the volume of transfusion and dosage blood products. Thus, our results showed that RAP approach effectively improved tissue perfusion and lowered intraoperative Lac levels, by reducing the hemodilution, which safely and reliably improve the microcirculation perfusion. PMID:27352335

  6. Effectiveness and safety of the Proxis system in demonstrating retrograde coronary blood flow during proximal occlusion and in capturing embolic material.

    PubMed

    Sievert, Horst; Wahr, Dennis W; Schuler, Gerhard; Schofer, Joachim J; Sutsch, Gabor; Pavliska, Jim; Skowasch, Marijke

    2004-11-01

    The Feasibility And Safety Trial for its embolic protection device during transluminal intervention in coronary vessels: a European Registry (FASTER) was designed to demonstrate that (1) the Proxis embolic protection system can control anterograde flow and reverse blood flow in native coronary arteries and saphenous vein grafts; and (2) this system can capture embolic debris. Percutaneous coronary intervention on stenotic coronary lesions revolutionized treatment of coronary disease, but is associated with the risk of major adverse cardiac events. This prospective, nonrandomized, multicenter clinical feasibility and safety study enrolled 40 patients with 51 lesions at 4 centers who underwent treatment of stenotic lesions with proximal emboli protection (Proxis system). Proxis was successfully used 95% of the time, and embolic debris was qualitatively identified in all cases. Major adverse cardiac events occurred in 2 patients (5.0%): 1 late in-stent thrombosis resulting in death and 1 non-Q-wave infarction when a lesion was crossed before deployment of the Proxis system. Mean vessel occlusion time was 4.3 +/- 2.4 minutes. Native flow reversal was sufficient in 31 patients, with a mean aspirate volume of 11.8 +/- 6.5 ml. When the infusion catheter was used to augment reflow, mean occlusion time was 4.6 minutes. In conclusion, this trial is the first to demonstrate that retrograde blood flow can be achieved during proximal occlusion and that the Proxis system can be used safely during intervention of saphenous vein grafts and native coronary arterial lesions to capture embolic material. PMID:15518607

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

    PubMed Central

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

    2015-01-01

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

  8. 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. PMID:26778839

  9. 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

  10. 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.

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

    PubMed Central

    Solanki, Archana; Singh, Abhay; Chaudhary, Rajendra

    2016-01-01

    Background: Enzyme-linked immunosorbent assay (ELISA) used for screening blood donors for transfusion transmitted infections (TTIs) can sometimes fail to detect blood donors who are recently infected or possessing the low strength of pathogen. Estimation of a grey zone in ELISA testing and repeat testing of grey zone samples can further help in reducing the risks of TTI in countries where nucleic acid amplification testing for TTIs is not feasible. Materials and Methods: Grey zone samples with optical density (OD) lying between cut-off OD and 10% below the cut-off OD (cut-off OD × 0.9) were identified during routine ELISA testing. On performing repeat ELISA testing on grey zone samples in duplicate, the samples showing both OD value below grey zone were marked nonreactive, and samples showing one or both OD value in the grey zone were marked indeterminate. The samples on repeat testing showing one or both OD above cut-off value were marked positive. Results: About 119 samples (77 for hepatitis B virus [HBV], 23 for human immunodeficiency virus [HIV], and 19 for hepatitis C virus [HCV]) were found to be in grey zone. On repeat testing of these samples in duplicate, 70 (58.8%) samples (45 for HBV, 12 for HIV, and 13 for HCV) were found to be reactive. Six (5%) samples (four for HBV, one for HIV, and one for HCV) were found to be indeterminate. Conclusion: Seventy donors initially screened negative, were found out to be potentially infectious on repeat grey zone testing. Thus, estimation of grey zone samples with repeat testing can further enhance the safety of blood transfusion. PMID:27011675

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

    MedlinePlus

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

  13. CLASSIFICATION OF THE MGR HEALTH SAFETY SYSTEM

    SciTech Connect

    J.A. Ziegler

    1999-08-31

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

  14. 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.

  15. Water Safety Quiz

    MedlinePlus

    ... Drive About Donating Blood Host a Blood Drive Training & Certification Find Classes First Aid CPR AED BLS Babysitting & Child Care Swimming Lifeguarding & Water Safety EMT CNA Train My Employees ...

  16. 10 CFR 71.101 - Quality assurance requirements.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ..., assembly, inspection, testing, operation, maintenance, repair, and modification of components of packaging... are responsible for the quality assurance requirements as they apply to design, fabrication, testing... Material Safety and Safeguards. (2) Before the fabrication, testing, or modification of any package for...

  17. 10 CFR 71.101 - Quality assurance requirements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ..., assembly, inspection, testing, operation, maintenance, repair, and modification of components of packaging... are responsible for the quality assurance requirements as they apply to design, fabrication, testing... Material Safety and Safeguards. (2) Before the fabrication, testing, or modification of any package for...

  18. 10 CFR 71.101 - Quality assurance requirements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ..., assembly, inspection, testing, operation, maintenance, repair, and modification of components of packaging... are responsible for the quality assurance requirements as they apply to design, fabrication, testing... Material Safety and Safeguards. (2) Before the fabrication, testing, or modification of any package for...

  19. 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.

  20. Competence assurance in a complex company

    SciTech Connect

    Clarke, C.C.; Sykes, R.M.

    1996-11-01

    Competence is the fundamental control that is used in industry to function in a safe and effective manner. Even after all mechanical interventions are applied within a system, the competence of human beings is relied upon to make the final decisions and to implement the ultimate actions. To be effective, an Organization must assure itself that all the controls and barriers that are necessary to keep the operations of the business within the designed envelope, are effectively working at or above the minimum required levels. This assurance applies equally to workforce competence as it does to alarms and other automatic control systems. The HSE Management System,/HSE Case methodology that evolved into regulation from the Cullen enquiry into the Piper Alpha disaster demands that specific competence must be in place, and that management must sign off that this is so. Assurance of competence involves identifying critical abilities and defining the standards to which they must be consistently performed, and then implementing a consistent and rigorous means of testing and validating the people who occupy roles that include critical abilities. This paper addresses with the methods that Shell Exploration and Production B.V. has developed to ensure that the competence are in place for critical occupational health, safety and environmental roles.

  1. 16 CFR 1101.32 - Reasonable steps to assure information is accurate.

    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 is accurate. 1101.32 Section 1101.32 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INFORMATION DISCLOSURE UNDER SECTION 6(b) OF THE CONSUMER PRODUCT SAFETY ACT Reasonable Steps Commission Will Take...

  2. 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.

  3. Long-Term (Postnatal Day 70) Outcome and Safety of Intratracheal Transplantation of Human Umbilical Cord Blood-Derived Mesenchymal Stem Cells in Neonatal Hyperoxic Lung Injury

    PubMed Central

    Ahn, So Yoon; Chang, Yun Sil; Kim, Soo Yoon; Sung, Dong Kyung; Kim, Eun Sun; Rime, So Yub; Yu, Wook Joon; Choi, Soo Jin; Oh, Won Il

    2013-01-01

    Purpose This study was performed to evaluate the long-term effects and safety of intratracheal (IT) transplantation of human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) in neonatal hyperoxic lung injury at postnatal day (P)70 in a rat model. Materials and Methods Newborn Sprague Dawley rat pups were subjected to 14 days of hyperoxia (90% oxygen) within 10 hours after birth and allowed to recover at room air until sacrificed at P70. In the transplantation groups, hUCB-MSCs (5×105) were administered intratracheally at P5. At P70, various organs including the heart, lung, liver, and spleen were histologically examined, and the harvested lungs were assessed for morphometric analyses of alveolarization. ED-1, von Willebrand factor, and human-specific nuclear mitotic apparatus protein (NuMA) staining in the lungs and the hematologic profile of blood were evaluated. Results Impaired alveolar and vascular growth, which evidenced by an increased mean linear intercept and decreased amount of von Willebrand factor, respectively, and the hyperoxia-induced inflammatory responses, as evidenced by inflammatory foci and ED-1 positive alveolar macrophages, were attenuated in the P70 rat lungs by IT transplantation of hUCB-MSCs. Although rare, donor cells with human specific NuMA staining were persistently present in the P70 rat lungs. There were no gross or microscopic abnormal findings in the heart, liver, or spleen, related to the MSCs transplantation. Conclusion The protective and beneficial effects of IT transplantation of hUCB-MSCs in neonatal hyperoxic lung injuries were sustained for a prolonged recovery period without any long-term adverse effects up to P70. PMID:23364976

  4. 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

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

    PubMed

    Downs, Matthew E; Buch, Amanda; Sierra, Carlos; Karakatsani, Maria Eleni; Teichert, Tobias; 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 (500 kHz, 200-400 kPa, 4-5 μm MB, 2 minute sonication). In this study, we repeatedly opened the BBB in the caudate and putamen regions of the basal ganglia of 4 NHP using FUS with systemically-administered MB over 4-20 months. We assessed the safety of the FUS with MB procedure using MRI to detect edema or hemorrhaging in the brain. Contrast enhanced T1-weighted MRI sequences showed a 98% success rate for openings in the targeted regions. T2-weighted and SWI sequences indicated a lack edema in the majority of the cases. We investigated potential neurological effects of the FUS with MB procedure through quantitative cognitive testing of' visual, cognitive, motivational, and motor function using a random dot motion task with reward magnitude bias presented on a touchpanel display. Reaction times during the task significantly increased on the day of the FUS with MB procedure. This increase returned to baseline within 4-5 days after the procedure. Visual motion discrimination thresholds were unaffected. Our results indicate FUS with MB can be a safe method for repeated opening of the BBB at the basal ganglia in NHP for up to 20 months without any long-term negative physiological or neurological effects with the parameters used. PMID:25945493

  6. 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

  7. Quality Assurance and Nursing Education

    ERIC Educational Resources Information Center

    Strauss, Mary Beth

    1978-01-01

    Preparation for quality assurance in nursing care must begin in basic nursing education, continue through the graduate and doctoral levels, and be provided for practicing nurses through continuing education activities, according to the author. She discusses the meaning of quality assurance and its integration into the nursing curriculum. (MF)

  8. 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…

  9. [The cost of quality assurance].

    PubMed

    Materson, B J; Quintana, O

    1993-01-01

    This paper views quality assurance costs as appraisal costs. We used cost accounting techniques to estimate the cost of quality assurance activities in a large university affiliated Veteran Administration Medical Center. In addition to the personnel employed full-time for quality assurance activities, all other employees in or directly in support of clinical services were interviewed in order to determine the per cent of their work time devoted to specific quality assurance activities. The per cent time committed was multiplied by the salary and benefits package for each employee and the total computed for the facility. In addition, non-salary overhead expenses were estimated by multiplying the salary and fringe benefit costs to the ratio of total medical center non-personnel costs to total medical center costs. We found that 3.39 per cent of the total budget or $4,884,775 was devoted to quality assurance activities. The highest costs aside from the designated quality assurance personnel were for pharmacy, Laboratory, extended care (including nursing home), psychiatry, and nursing services. We did not attempt a formal benefit analysis. We concluded that quality assurance activities in a major medical center are not free. Careful cost accounting studies should be performed both to determine the cost of quality assurance and to identify its specific benefits. PMID:8322107

  10. Quality Assurance in Education Systems.

    ERIC Educational Resources Information Center

    Cuttance, Peter

    1994-01-01

    This paper provides an analysis of approaches to quality assurance and of the management of quality in general management literature and considers its application to public education systems. Key components of a fully integrated approach to quality assurance and quality management for school systems are listed. (SLD)

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

    SciTech Connect

    Not Available

    1986-01-01

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

  12. [Ballistic quality assurance].

    PubMed

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

    2012-06-01

    This review describes the ballistic quality assurance for stereotactic intracranial irradiation treatments delivered with Gamma Knife® either dedicated or adapted medical linear accelerators. Specific and periodic controls should be performed in order to check the mechanical stability for both irradiation and collimation systems. If this step remains under the responsibility of the medical physicist, it should be done in agreement with the manufacturer's technical support. At this time, there are no recent published guidelines. With technological developments, both frequency and accuracy should be assessed in each institution according to the treatment mode: single versus hypofractionnated dose, circular collimator versus micro-multileaf collimators. In addition, "end-to-end" techniques are mandatory to find the origin of potential discrepancies and to estimate the global ballistic accuracy of the delivered treatment. Indeed, they include frames, non-invasive immobilization devices, localizers, multimodal imaging for delineation and in-room positioning imaging systems. The final precision that could be reasonably achieved is more or less 1mm. PMID:22632786

  13. 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.

  14. 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.

  15. 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

  16. 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...

  17. 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.

  18. Multi-Modality Safety Assessment of Blood-Brain Barrier Opening Using Focused Ultrasound and Definity Microbubbles: A Short-Term Study

    PubMed Central

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

    2014-01-01

    As a potentially viable method of brain drug delivery, the safety profile of blood-brain barrier (BBB) opening using focused ultrasound (FUS) and ultrasound contrast agents (UCA) needs to be established. In this study, we provide a short-term (30 min or 5h survival) histological assessment of murine brains undergoing FUS-induced BBB opening. Forty-nine mice were intravenously injected with Definity® microbubbles (0.05 μl/kg) and sonicated under the following parameters: frequency of 1.525 MHz, burst length of 20 ms, PRF of 10 Hz, peak rarefactional acoustic pressures of 0.15-0.98 MPa, and two 30-s sonication intervals with an intermittent 30-s delay. The BBB opening threshold was found to be 0.15-0.3 MPa based on fluorescence and MR imaging of systemically-injected tracers. Analysis of three histological measures in H&E-stained sections revealed the safest acoustic pressure to be within the range of 0.3-0.46 MPa in all examined time periods post sonication. Across different pressure amplitudes, only the samples 30 min post-opening showed significant difference (p<0.05) in the average number of distinct damaged sites, microvacuolated sites, dark neurons, and sites with extravasated erythrocytes. Enhanced fluorescence around severed microvessels was also noted and found to be associated with the largest tissue effects while mildly diffuse BBB opening with uniform fluorescence in the parenchyma was associated with no or mild tissue injury. Region-specific areas of the sonicated brain (thalamus, hippocampal fissure, dentate gyrus, and CA3 area of hippocampus) exhibited variation in fluorescence intensity based on the position, orientation, and size of affected vessels. The results of this short-term histological analysis demonstrated the feasibility of a safe FUS-UCA-induced BBB opening under a specific set of sonication parameters and provided new insights on the mechanism of BBB opening. PMID:20800172

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

    PubMed

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

    2015-01-01

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

  20. Safety of hydrogen pressure gauges.

    NASA Technical Reports Server (NTRS)

    Voth, R. O.

    1972-01-01

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

  1. 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...

  2. 24 CFR 8.50 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Assurances required. 8.50 Section 8... URBAN DEVELOPMENT Enforcement § 8.50 Assurances required. (a) Assurances. An applicant for Federal financial assistance for a program or activity to which this part applies shall submit an assurance to...

  3. 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…

  4. 45 CFR 605.5 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 3 2010-10-01 2010-10-01 false Assurances required. 605.5 Section 605.5 Public... Provisions § 605.5 Assurances required. (a) Assurances. Recipients of Federal financial assistance to which... structures on the property, the assurance will obligate the recipient or, in the case of a...

  5. 15 CFR 8b.5 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 15 Commerce and Foreign Trade 1 2010-01-01 2010-01-01 false Assurances required. 8b.5 Section 8b.5... Assurances required. (a) Assurances. An applicant for Federal financial assistance to which this part applies shall submit an assurance, on a form specified by the Secretary, that the program or activity will...

  6. 29 CFR 32.5 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 1 2010-07-01 2010-07-01 true Assurances required. 32.5 Section 32.5 Labor Office of the... FINANCIAL ASSISTANCE General Provisions § 32.5 Assurances required. (a) Assurances. An applicant for Federal financial assistance to which this part applies shall submit an assurance, on a form specified by...

  7. 34 CFR 110.23 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Assurances required. 110.23 Section 110.23 Education... Recipients § 110.23 Assurances required. (a) Assurances. An applicant for Federal financial assistance to which these regulations apply shall sign a written assurance, on a form specified by ED, that...

  8. 45 CFR 1170.51 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 3 2010-10-01 2010-10-01 false Assurances required. 1170.51 Section 1170.51... ASSISTED PROGRAMS OR ACTIVITIES Enforcement § 1170.51 Assurances required. (a) Assurances. An applicant for Federal financial assistance to which this part applies shall submit an assurance, on a form specified...

  9. 14 CFR 1251.104 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Assurances required. 1251.104 Section 1251... HANDICAP General Provisions § 1251.104 Assurances required. (a) Assurances. An applicant for Federal financial assistance to which this part applies shall submit an assurance, on a form specified by...

  10. 34 CFR 104.5 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Assurances required. 104.5 Section 104.5 Education... Provisions § 104.5 Assurances required. (a) Assurances. An applicant for Federal financial assistance to which this part applies shall submit an assurance, on a form specified by the Assistant Secretary,...

  11. 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...

  12. Mixed Waste Integrated Program Quality Assurance requirements plan

    SciTech Connect

    Not Available

    1994-04-15

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

  13. 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.

  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. 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...

  16. Blood Disorders

    MedlinePlus

    ... and protein. Over half of your blood is plasma. The solid part of your blood contains red blood cells, white blood cells and platelets. Blood disorders affect one or more parts of the blood and prevent ...

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

    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 fair in the circumstances. 1101.33 Section 1101.33 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INFORMATION DISCLOSURE UNDER SECTION 6(b) OF THE...

  18. 76 FR 33188 - Quality Assurance Requirements for Respirators; Notice of Withdrawal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-08

    ...The Department of Health and Human Services (HHS) is withdrawing its proposed rule to update the quality assurance and control requirements for the manufacture of respirators approved under 42 CFR Part 84 by the National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention and the Mine Safety and Health Administration (MSHA). NIOSH has reviewed the......

  19. 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

  20. 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.

  1. Blood sugar test - blood

    MedlinePlus

    ... drink a certain amount of glucose ( oral glucose tolerance test ) How the Test will Feel When the ... a fasting blood glucose, HbA1c test , or glucose tolerance test , depending on your random blood glucose test ...

  2. NASA Space Shuttle Program: Shuttle Environmental Assurance (SEA) Initiative

    NASA Technical Reports Server (NTRS)

    Glover, Steve E.; McCool, Alex (Technical Monitor)

    2002-01-01

    The first Space Shuttle flight was in 1981 and the fleet was originally expected to be replaced with a new generation vehicle in the early 21st century. Space Shuttle Program (SSP) elements proactively address environmental and obsolescence concerns and continue to improve safety and supportability. The SSP manager created the Shuttle Environmental Assurance (SEA) Initiative in 2000. SEA is to provide an integrated approach for the SSP to promote environmental excellence, proactively manage materials obsolescence, and optimize associated resources.

  3. 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.

  4. 76 FR 10937 - Public Notice for Waiver of Aeronautical Land-Use Assurance Holmes County Airport, Millersburg, OH

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-28

    ... Federal Aviation Administration Public Notice for Waiver of Aeronautical Land-Use Assurance Holmes County... development, safety, or compatible land use. The intended land use is to remain vacant. Approval does not... Federal Register 30 days before modifying the land-use assurance that requires the property to be used...

  5. Waste Management Quality Assurance Plan

    SciTech Connect

    Waste Management Group

    2006-08-14

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

  6. Quality assurance of endoscopy units.

    PubMed

    Stebbing, John F

    2011-06-01

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

  7. 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.

  8. Hand Safety

    MedlinePlus

    ... en gatillo See More... Hand Anatomy Hand Safety Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening ... en gatillo See More... Hand Anatomy Hand Safety Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening ...

  9. Hand Safety

    MedlinePlus

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

  10. 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…

  11. Quality Assurance in School Health

    ERIC Educational Resources Information Center

    Newell, Susan; Schoenike, Sumner L.; Lisko, Elaine A.

    2003-01-01

    School nurses need to become more influential administrators, managers, and entrepreneurs. They must learn to lead and collaborate effectively in designing, implementing, and evaluating coordinated school health programs. Quality assurance is an essential ingredient in this process that requires accurate, timely, and confidential incident…

  12. 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.

  13. Quality assurance planning and structure.

    PubMed

    Jackman, W; Brown, L D; Al-assaf, A F; Reinke, J M; Abubaker, W; Winter, L; Murphy, G; Blumenfeld, S

    1995-01-01

    Planning for the introduction, implementation, and conduct of quality assurance activities has been the key issue from the outset of the project. Despite the various approaches to planning, no single Quality Assurance (QA) planning can be universally accepted by developing countries due to variations in the socioeconomic, cultural and political makeup of individual countries. This paper summarizes the lessons learned from the Quality Assurance Project in planning a QA program: 1) the need to understand organizational strengths and weaknesses to develop appropriate strategies for QA skills training and organizational change; 2) the need to build on existing systems or activities that support the objectives of the organization and provide an adequate foundation for the QA program; 3) the need to assign responsibility for quality assurance through the creation of QA councils and committees and the assignment of coordinators and other individuals; 4) the need to secure top-level management support to legitimize any changes; 5) the need to determine the method of introducing innovations into organizations, either by a top-down or bottom-up approach; 6) the plan should have well-defined priorities and objectives despite its flexibility as projects evolve and grow over time. PMID:12295830

  14. Vomiting blood

    MedlinePlus

    ... first part of the small intestine, or esophagus Blood clotting disorders Defects in the blood vessels of the ... as a complete blood count (CBC), blood chemistries, blood clotting tests, and liver function tests Esophagogastroduodenoscopy (EGD) (placing ...

  15. Blood pressure

    MedlinePlus Videos and Cool Tools

    Normal blood pressure is important for proper blood flow to the body’s organs and tissues. The force of the blood on the walls of the arteries is called blood pressure. Blood pressure is measured both as the heart ...

  16. Blood transfusions

    MedlinePlus

    ... homologous blood donation. Many communities have a blood bank at which any healthy person can donate blood. ... to arrange with your hospital or local blood bank before your surgery to have directed donor blood. ...

  17. Blood pressure

    MedlinePlus Videos and Cool Tools

    Normal blood pressure is important for proper blood flow to the body’s organs and tissues. The force of the blood on the walls of the arteries is called blood pressure. Blood pressure is measured both ...

  18. 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.

  19. 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

  20. 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.

  1. 45 CFR 1110.4 - Assurances required.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... General Services Administration. (41 CFR 101-6.2) (b) Continuing Federal financial assistance. Every... shall specify the form of the foregoing assurances and the extent to which like assurances will...

  2. 45 CFR 1110.4 - Assurances required.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... General Services Administration. (41 CFR 101-6.2) (b) Continuing Federal financial assistance. Every... shall specify the form of the foregoing assurances and the extent to which like assurances will...

  3. 22 CFR 209.5 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Administrator of General Services (41 CFR 101-6.2). (b) Assurances from institutions. (1) In the case of any... which like assurances will be required of subgrantees, contractors and subcontractors,...

  4. 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.

  5. 28 CFR 42.504 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...-Implementation of Section 504 of the Rehabilitation Act of 1973 General Provisions § 42.504 Assurances required... shall contain a covenant running with the land assuring nondiscrimination on the condition described...

  6. 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...

  7. 48 CFR 370.402 - Assurances.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... SPECIAL PROGRAMS AFFECTING ACQUISITION Acquisitions Involving the Use of Laboratory Animals 370.402 Assurances. (a) Assurances may be one of two following types: (1) Full Animal Welfare Assurance (AWA). An AWA... of Laboratory Animal Welfare, NIH MSC 7507, 6100 Executive Blvd., Room 3B01, Rockville,...

  8. 48 CFR 370.402 - Assurances.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... SPECIAL PROGRAMS AFFECTING ACQUISITION Acquisitions Involving the Use of Laboratory Animals 370.402 Assurances. (a) Assurances may be one of two following types: (1) Full Animal Welfare Assurance (AWA). An AWA... of Laboratory Animal Welfare, NIH MSC 7507, 6100 Executive Blvd., Room 3B01, Rockville,...

  9. 48 CFR 370.402 - Assurances.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... SPECIAL PROGRAMS AFFECTING ACQUISITION Acquisitions Involving the Use of Laboratory Animals 370.402 Assurances. (a) Assurances may be one of two following types: (1) Full Animal Welfare Assurance (AWA). An AWA... of Laboratory Animal Welfare, NIH MSC 7507, 6100 Executive Blvd., Room 3B01, Rockville,...

  10. Characteristics to Evaluate the Quality Assurance Workforce.

    ERIC Educational Resources Information Center

    Reynolds, Craig Otis

    Quality assurance is a vital part of any Navy contract administration activity. It is essential that the personnel involved in quality assurance be of extremely high caliber. The purpose of the paper is to develop a model of the educational background of an ideal quality assurance man. The paper outlines the functions which might be required of…

  11. 40 CFR 31.45 - 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. 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,...

  12. 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...

  13. 13 CFR 113.4 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Assurances required. 113.4 Section... Provisions § 113.4 Assurances required. An application for financial assistance shall, as a condition to its approval and the extension of such assistance, contain or be accompanied by an assurance that the...

  14. 43 CFR 41.115 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Assurance required. 41.115 Section 41.115... EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE Introduction § 41.115 Assurance..., be accompanied by, or be covered by a specifically identified assurance from the applicant...

  15. 15 CFR 8a.115 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 15 Commerce and Foreign Trade 1 2010-01-01 2010-01-01 false Assurance required. 8a.115 Section 8a... Assurance required. (a) General. Either at the application stage or the award stage, Federal agencies must... contain, be accompanied by, or be covered by a specifically identified assurance from the applicant...

  16. 18 CFR 705.5 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 18 Conservation of Power and Water Resources 2 2010-04-01 2010-04-01 false Assurance required. 705... Assurance required. (a) General. Every application for Federal financial assistance to carry out a program... pursuant to the application, contain or be accompanied by an assurance that the program will be...

  17. 10 CFR 5.115 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Assurance required. 5.115 Section 5.115 Energy NUCLEAR... FEDERAL FINANCIAL ASSISTANCE Introduction § 5.115 Assurance required. (a) General. Either at the... specifically identified assurance from the applicant or recipient, satisfactory to the designated...

  18. 49 CFR 21.7 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false Assurances required. 21.7 Section 21.7... DEPARTMENT OF TRANSPORTATION-EFFECTUATION OF TITLE VI OF THE CIVIL RIGHTS ACT OF 1964 § 21.7 Assurances... Federal financial assistance pursuant to the application, contain or be accompanied by, an assurance...

  19. 31 CFR 28.115 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 1 2010-07-01 2010-07-01 false Assurance required. 28.115 Section 28....115 Assurance required. (a) General. Either at the application stage or the award stage, Federal... assistance contain, be accompanied by, or be covered by a specifically identified assurance from...

  20. 38 CFR 23.115 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Assurance required. 23... Introduction § 23.115 Assurance required. (a) General. Either at the application stage or the award stage... financial assistance contain, be accompanied by, or be covered by a specifically identified assurance...

  1. 14 CFR 1253.115 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Assurance required. 1253.115 Section 1253....115 Assurance required. (a) General. Either at the application stage or the award stage, Federal... assistance contain, be accompanied by, or be covered by a specifically identified assurance from...

  2. 43 CFR 34.5 - Assurances.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Assurances. 34.5 Section 34.5 Public Lands... OPERATION OF THE ALASKA NATURAL GAS TRANSPORTATION SYSTEM § 34.5 Assurances. Every application for a... subcontractor to which this Part applies, must contain an assurance that the recipient, contractor,...

  3. 34 CFR 106.4 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Assurance required. 106.4 Section 106.4 Education... Introduction § 106.4 Assurance required. (a) General. Every application for Federal financial assistance shall as condition of its approval contain or be accompanied by an assurance from the applicant...

  4. 22 CFR 146.115 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Assurance required. 146.115 Section 146.115... PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE Introduction § 146.115 Assurance required. (a... by, or be covered by a specifically identified assurance from the applicant or...

  5. 13 CFR 117.7 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Assurances required. 117.7 Section....7 Assurances required. An application for financial assistance administered by the Small Business... accompanied by an assurance that the recipient will comply with this part. SBA shall specify the form of...

  6. 29 CFR 35.23 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 1 2010-07-01 2010-07-01 true Assurances required. 35.23 Section 35.23 Labor Office of the... FINANCIAL ASSISTANCE FROM THE DEPARTMENT OF LABOR Duties of DOL Recipients § 35.23 Assurances required. A recipient or applicant for Federal financial assistance from DOL shall sign a written assurance, in a...

  7. 44 CFR 7.7 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Assurances required. 7.7... in FEMA-Assisted Programs-General § 7.7 Assurances required. Every application for Federal financial... assistance pursuant to the application, contain or be accompanied by an assurance that the program will...

  8. 45 CFR 1151.41 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 3 2010-10-01 2010-10-01 false Assurances required. 1151.41 Section 1151.41... Assurances required. (a) An applicant for federal financial assistance to which this part applies shall submit an assurance, on a form specified by the Chairman, that the program or activity will be...

  9. 29 CFR 36.115 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 1 2010-07-01 2010-07-01 true Assurance required. 36.115 Section 36.115 Labor Office of... RECEIVING FEDERAL FINANCIAL ASSISTANCE Introduction § 36.115 Assurance required. (a) General. Either at the... specifically identified assurance from the applicant or recipient, satisfactory to the designated...

  10. 45 CFR 1232.5 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 4 2010-10-01 2010-10-01 false Assurances required. 1232.5 Section 1232.5 Public... Provisions § 1232.5 Assurances required. (a) An applicant for Federal financial assistance to which this part applies shall submit an assurance, on a form specified by the Director, that the program or activity...

  11. 7 CFR 15a.4 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 1 2010-01-01 2010-01-01 false Assurance required. 15a.4 Section 15a.4 Agriculture... FEDERAL FINANCIAL ASSISTANCE Introduction § 15a.4 Assurance required. (a) General. Every application for... contain or be accompanied by an assurance from the applicant or recipient, satisfactory to the...

  12. 29 CFR 530.103 - Employer assurances.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 3 2010-07-01 2010-07-01 false Employer assurances. 530.103 Section 530.103 Labor... OF HOMEWORKERS IN CERTAIN INDUSTRIES Homeworker Employer Certificates § 530.103 Employer assurances... employer must provide written assurances concerning the employment of homeworkers subject to section...

  13. 22 CFR 229.115 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Assurance required. 229.115 Section 229.115... PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE Introduction § 229.115 Assurance required. (a... by, or be covered by a specifically identified assurance from the applicant or...

  14. 24 CFR 1.5 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Assurances required. 1.5 Section 1... TITLE VI OF THE CIVIL RIGHTS ACT OF 1964 § 1.5 Assurances required. (a) General. (1) Every contract for... assistance pursuant to such contract or application, contain or be accompanied by an assurance that...

  15. 13 CFR 112.8 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Assurances required. 112.8 Section... ASSISTED PROGRAMS OF SBA-EFFECTUATION OF TITLE VI OF THE CIVIL RIGHTS ACT OF 1964 § 112.8 Assurances... to its approval and the extension of such assistance, contain or be accompanied by an assurance...

  16. 28 CFR 42.105 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Assurance required. 42.105 Section 42.105... Act of 1964 1 § 42.105 Assurance required. (a) General. (1) Every application for Federal financial... pursuant to the application, contain or be accompanied by an assurance that the program will be...

  17. 44 CFR 19.115 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Assurance required. 19.115... RECEIVING FEDERAL FINANCIAL ASSISTANCE Introduction § 19.115 Assurance required. (a) General. Either at the... specifically identified assurance from the applicant or recipient, satisfactory to the designated...

  18. 45 CFR 2555.115 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 4 2010-10-01 2010-10-01 false Assurance required. 2555.115 Section 2555.115... FINANCIAL ASSISTANCE Introduction § 2555.115 Assurance required. (a) General. Either at the application... specifically identified assurance from the applicant or recipient, satisfactory to the designated...

  19. 22 CFR 142.5 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Assurances required. 142.5 Section 142.5... OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE General Provisions § 142.5 Assurances required. (a) Assurances. An applicant for Federal financial assistance to which this part applies shall...

  20. 18 CFR 1317.115 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 18 Conservation of Power and Water Resources 2 2010-04-01 2010-04-01 false Assurance required... Introduction § 1317.115 Assurance required. (a) General. Either at the application stage or the award stage... financial assistance contain, be accompanied by, or be covered by a specifically identified assurance...

  1. 5 CFR 900.405 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Assurances required. 900.405 Section 900... Assurances required. (a) General. (1) An application for Federal financial assistance to carry out a program... accompanied by, assurances that the program will be conducted or the facility operated in compliance with...

  2. 28 CFR 54.115 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Assurance required. 54.115 Section 54.115... EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE Introduction § 54.115 Assurance..., be accompanied by, or be covered by a specifically identified assurance from the applicant...

  3. 29 CFR 31.6 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 1 2010-07-01 2010-07-01 true Assurances required. 31.6 Section 31.6 Labor Office of the... OF TITLE VI OF THE CIVIL RIGHTS ACT OF 1964 § 31.6 Assurances required. (a) General. (1) Every... arrangement contain or be accompanied by an assurance that the program will be conducted or the...

  4. 24 CFR 3.115 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Assurance required. 3.115 Section 3... Introduction § 3.115 Assurance required. (a) General. Either at the application stage or the award stage... financial assistance contain, be accompanied by, or be covered by a specifically identified assurance...

  5. 49 CFR 27.9 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false Assurance required. 27.9 Section 27.9... OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE General § 27.9 Assurance required. (a) General... pursuant to the application, contain, or be accompanied by, written assurance that the program or...

  6. 6 CFR 17.115 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 6 Domestic Security 1 2010-01-01 2010-01-01 false Assurance required. 17.115 Section 17.115....115 Assurance required. (a) General. Either at the application stage or the award stage, Federal... assistance contain, be accompanied by, or be covered by a specifically identified assurance from...

  7. 22 CFR 141.4 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Assurances required. 141.4 Section 141.4... DEPARTMENT OF STATE-EFFECTUATION OF TITLE VI OF THE CIVIL RIGHTS ACT OF 1964 § 141.4 Assurances required. (a..., shall contain or be accompanied by an assurance that the program will be conducted or the...

  8. 7 CFR 15b.5 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 1 2010-01-01 2010-01-01 false Assurances required. 15b.5 Section 15b.5 Agriculture... ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE General Provisions § 15b.5 Assurances required. (a) Assurances. An applicant for Federal financial assistance to which this part applies shall submit...

  9. 32 CFR 196.115 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 2 2010-07-01 2010-07-01 false Assurance required. 196.115 Section 196.115... FINANCIAL ASSISTANCE Introduction § 196.115 Assurance required. (a) General. Either at the application stage... identified assurance from the applicant or recipient, satisfactory to the designated agency official,...

  10. 43 CFR 27.4 - Assurances.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Assurances. 27.4 Section 27.4 Public Lands... PUBLIC LAW 93-153 § 27.4 Assurances. Every application for a permit, right-of-way, public land order, or... an assurance that the recipient, contractor, or subcontractor does not and will not maintain...

  11. 49 CFR 25.115 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false Assurance required. 25.115 Section 25.115... PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE Introduction § 25.115 Assurance required. (a... by, or be covered by a specifically identified assurance from the applicant or...

  12. 36 CFR 1211.115 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 3 2010-07-01 2010-07-01 false Assurance required. 1211.115... FINANCIAL ASSISTANCE Introduction § 1211.115 Assurance required. (a) General. Either at the application... specifically identified assurance from the applicant or recipient, satisfactory to the designated...

  13. 45 CFR 86.4 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false Assurance required. 86.4 Section 86.4 Public... Assurance required. (a) General. Every application for Federal financial assistance for any education program or activity shall as condition of its approval contain or be accompanied by an assurance from...

  14. 43 CFR 17.204 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Assurances required. 17.204 Section 17.204... PROGRAMS OF THE DEPARTMENT OF THE INTERIOR Nondiscrimination on the Basis of Handicap § 17.204 Assurances required. (a) Assurances. An applicant for Federal financial assistance to which this subpart applies...

  15. 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...

  16. 50 CFR 600.240 - Security assurances.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 50 Wildlife and Fisheries 12 2013-10-01 2013-10-01 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...

  17. Assuring Residential Quality: Issues, Approaches and Instruments.

    ERIC Educational Resources Information Center

    Bersani, Hank A., Jr.

    This report begins with discussion of several issues in the field of quality assurance in residential services for individuals with developmental disabilities. The issues include definitions of key terms, the role of ideology, major types of quality assurance, and dimensions of quality assurance. The report takes the position that primary values…

  18. 40 CFR 31.45 - 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. 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,...

  19. 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...

  20. 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 Tradition: Measuring Quality by…

  1. 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)

  2. Detection of cell-free, liver-specific mRNAs in peripheral blood from rats with hepatotoxicity: a potential toxicological biomarker for safety evaluation.

    PubMed

    Miyamoto, Makoto; Yanai, Mariko; Ookubo, Shingo; Awasaki, Naoko; Takami, Kenji; Imai, Ryoetsu

    2008-12-01

    To verify the concept that cell-free organ/tissue-specific mRNAs leaking from drug-damaged organs/tissues into peripheral blood could be toxicological biomarkers for identification of the target organs of drug toxicity, we attempted to detect liver-specific mRNAs in peripheral blood from rats with chemical-induced hepatotoxicity. We selected alpha(1)-microglobulin/bikunin precursor (Ambp) and albumin mRNAs as tentative liver-specific biomarkers and successfully detected them by reverse transcription (RT)-PCR in peripheral blood 24 h after D-galactosamine HCl (D-gal) or acetaminophen administration. Moreover, albumin mRNA was detected 2 h after D-gal administration, although plasma alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels were still unchanged. On the other hand, in peripheral blood from rat with bupivacaine HCl-induced skeletal muscle damage, neither Ambp nor albumin mRNA was detectable while plasma creatine kinase, ALT, and AST levels prominently increased 2 or 12 h after dosing. Furthermore, Ambp mRNA was also detectable in filtered plasma from rats with liver damage, indicating that cell-free Ambp mRNA can be present in peripheral blood. In conclusion, cell-free, liver-specific Ambp, and albumin mRNAs were detectable in peripheral blood from rats with chemical-induced liver damage. It is believed that the detection of cell-free organ/tissue-specific mRNA in peripheral blood is a promising approach in the survey of toxicological biomarkers. PMID:18779383

  3. 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.

  4. 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.

  5. 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... to a new entrant that its USDOT new entrant registration will be revoked? (a) General. The...

  6. 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

  7. Assuring eating quality of meat.

    PubMed

    Dalen, G A

    1996-01-01

    The way of assuring quality has changed over the years, from inspection of end product to quality management systems and on-line process control. The latter concepts have had a great impact in many industries during the last decades. But the concept of Total Quality is continuos improvement so it is time to take advantage of the next generation of quality assurance tools: Quality by Design. This is the most powerful instrument in quality assurance today. Quality by design has been used with outstanding results in many industries as the automobile and the electronics industry. Maybe the meat industry will be the next? To succeed, the "eating quality attributes" that are most important to the customer must be brought into focus. The challenge to the meat research scientist is to design products and processes that take care of customer needs despite variation in the raw material and the consumer's rough handling. The Quality Management Standards are helpful in conducting the design and production process, but to focus on the right aspects, there also are need for suitable methods as Quality Function Deployment. Customer needs change and new research changes old 'truths'. This require an organisation, a quality system and a culture which can handle rapid changes and a diversity of customer needs. PMID:22060638

  8. 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....

  9. 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.

  10. 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.

  11. Medical Devices; hematology and pathology devices; reclassification of automated blood cell separator device operating by filtration principle from class III to class II. Final rule.

    PubMed

    2003-02-28

    The Food and Drug Administration (FDA) is reclassifying the automated blood cell separator (ABCS) device operating by filtration principle, intended for routine collection of blood and blood components, from class III to class II (special controls). The special control requirement for this device is an annual report with emphasis on adverse reactions to be filed by the manufacturer for a minimum of 3 years. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is reclassifying the automated blood cell separator devices operating by filtration principle into class II (special controls) because special controls, in addition to general controls, are capable of providing a reasonable assurance of safety and effectiveness of the device. PMID:12617085

  12. 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.

  13. 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.

  14. Quality Assurance Program description, Defense Waste Processing Facility (DWPF)

    SciTech Connect

    Maslar, S.R.

    1992-11-02

    This document describes the Westinghouse Savannah River Company's (WSRC) Quality Assurance Program for Defense Waste Processing at the Savannah River Site (SRS). WSRC is the operating contractor for the US Department of Energy (DOE) at the SRS. The following objectives are achieved through developing and implementing the Quality Assurance Program: (1) Ensure that the attainment of quality (in accomplishing defense high-level waste processing objectives at the SRS) is at a level commensurate with the government's responsibility for protecting public health and safety, the environment, the public investment, and for efficiently and effectively using national resources. (2) Ensure that high-level waste from qualification and production activities conform to requirements defined by OCRWM. These activities include production processes, equipment, and services; and products that are planned, designed, procured, fabricated, installed, tested, operated, maintained, modified, or produced.

  15. 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.

  16. Donating Blood

    MedlinePlus

    ... can give blood every 56 days. Before Donating Blood donation starts before you walk in the door of ... regenerate the red blood cells lost during a blood donation. An iron-fortified diet plus daily iron tablets ...

  17. Blood culture

    MedlinePlus

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

  18. Blood Thinners

    MedlinePlus

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

  19. Blood sugar test - blood

    MedlinePlus

    ... in the way you normally talk or behave Fainting spells Seizures (for the first time) SCREENING FOR ... drawn are slight, but may include: Excessive bleeding Fainting or feeling lightheaded Hematoma (blood accumulating under the ...

  20. Cytokine release assays for the prediction of therapeutic mAb safety in first-in man trials--Whole blood cytokine release assays are poorly predictive for TGN1412 cytokine storm.

    PubMed

    Vessillier, S; Eastwood, D; Fox, B; Sathish, J; Sethu, S; Dougall, T; Thorpe, S J; Thorpe, R; Stebbings, R

    2015-09-01

    The therapeutic monoclonal antibody (mAb) TGN1412 (anti-CD28 superagonist) caused near-fatal cytokine release syndrome (CRS) in all six volunteers during a phase-I clinical trial. Several cytokine release assays (CRAs) with reported predictivity for TGN1412-induced CRS have since been developed for the preclinical safety testing of new therapeutic mAbs. The whole blood (WB) CRA is the most widely used, but its sensitivity for TGN1412-like cytokine release was recently criticized. In a comparative study, using group size required for 90% power with 5% significance as a measure of sensitivity, we found that WB and 10% (v/v) WB CRAs were the least sensitive for TGN1412 as these required the largest group sizes (n = 52 and 79, respectively). In contrast, the peripheral blood mononuclear cell (PBMC) solid phase (SP) CRA was the most sensitive for TGN1412 as it required the smallest group size (n = 4). Similarly, the PBMC SP CRA was more sensitive than the WB CRA for muromonab-CD3 (anti-CD3) which stimulates TGN1412-like cytokine release (n = 4 and 4519, respectively). Conversely, the WB CRA was far more sensitive than the PBMC SP CRA for alemtuzumab (anti-CD52) which stimulates FcγRI-mediated cytokine release (n = 8 and 180, respectively). Investigation of potential factors contributing to the different sensitivities revealed that removal of red blood cells (RBCs) from WB permitted PBMC-like TGN1412 responses in a SP CRA, which in turn could be inhibited by the addition of the RBC membrane protein glycophorin A (GYPA); this observation likely underlies, at least in part, the poor sensitivity of WB CRA for TGN1412. The use of PBMC SP CRA for the detection of TGN1412-like cytokine release is recommended in conjunction with adequately powered group sizes for dependable preclinical safety testing of new therapeutic mAbs. PMID:25960173

  1. 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.

  2. 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.

  3. 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...

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Quality assurance in orthodontic radiography.

    PubMed

    Brown, J E

    1995-02-01

    The implementation of a Quality Assurance (QA) programme in orthodontic radiography is designed to improve the quality of the resultant radiographs and to reduce the number of repeat exposures. This is particularly desirable in orthodontic practice where the majority of patients are young and therefore more at risk from the detrimental effects of X-rays. A programme is described and QA tests are given that may be applied in the surgery. Particular emphasis is placed on QA measures for extraoral radiography, since this is frequently undertaken in the treatment of the orthodontic patient. PMID:7786872

  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. Helical tomotherapy dynamic quality assurance

    SciTech Connect

    Balog, John; Holmes, Tim; Vaden, Richard

    2006-10-15

    A multifaceted tomotherapy quality assurance procedure has been developed. This procedure tests most of the features inherent in the tomotherapy Hi-Art device. This includes the megavoltage imaging quality, spatial and temporal accuracy of the dynamic delivery properties, as well as more traditional beam output characteristics. This is accomplished with a specialized multichannel electrometer that measures collected charge every 100 ms and a Virtual Water cylindrical phantom that holds many ion chambers and differing density insert plugs. Both devices are offered with the Hi-Art product. These tests are presented as well as their sensitivity to beam and delivery variations.

  12. 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.

  13. Regulatory compliance, management assurance drive environmental audits

    SciTech Connect

    Diberto, M. )

    1994-07-01

    As environmental protection takes on greater priority, more companies are developing environmental auditing programs. Details of these programs vary, but they share a basic goal--to verify that environmental, health and safety activities comply with company policies, and federal, state and local regulations. The growth of environmental auditing has been driven by the same forces that since 1970 have changed many aspects the business-environment relationship. In addition, regulations, court case precedents and public expectations are forcing companies to disclose much more about their environmental performance than in the past. The handful of companies that developed auditing programs considered them internal tools for evaluating environmental performance in their facilities and operations. As the discipline has spread and environmental regulations have proliferated, auditing increasingly has been driven by a need to assure senior management that their companies are in compliance and sound environmental procedures are being used. To achieve these goals, companies systematically design and conduct environmental audits to address relevant concerns, and appropriately document and report all findings.

  14. 7 CFR 1724.55 - Dam safety.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Guidelines for Dam Safety,”FEMA 93, June, 1979, published by the Federal Emergency Management Agency (FEMA...“Federal Guidelines for Dam Safety”may be obtained from the Federal Emergency Management Agency, Mitigation... with Appendix E of the U.S. Army Corps of Engineers Engineering and Design Dam Safety Assurance...

  15. 7 CFR 1724.55 - Dam safety.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Guidelines for Dam Safety,”FEMA 93, June, 1979, published by the Federal Emergency Management Agency (FEMA...“Federal Guidelines for Dam Safety”may be obtained from the Federal Emergency Management Agency, Mitigation... with Appendix E of the U.S. Army Corps of Engineers Engineering and Design Dam Safety Assurance...

  16. 7 CFR 1724.55 - Dam safety.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Guidelines for Dam Safety,”FEMA 93, June, 1979, published by the Federal Emergency Management Agency (FEMA...“Federal Guidelines for Dam Safety”may be obtained from the Federal Emergency Management Agency, Mitigation... with Appendix E of the U.S. Army Corps of Engineers Engineering and Design Dam Safety Assurance...

  17. 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.

  18. 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…

  19. 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.

  20. Quality assurance for purchased catalysts

    SciTech Connect

    Puls, F.H. )

    1988-09-01

    Petrochemical industries require many different types of catalysts in process operations. A significantly portion of these requirements is being met through purchases from merchant catalyst suppliers. The importance of catalysts and of catalyst quality to these industries cannot be overstated. It is not surprising that in the quest for quality which has affected much of US industry in the last few years, catalysts were among the first products which were singled out for development of quality assurance. Currently, catalyst supplier auditing and certification procedures are being implemented. Primary emphasis is on the implementation of statistical process control procedures in the manufacture of commercially available catalyst. Thus, a trend exists to move from quality assurance (QA) and quality control (QC) for purchased catalysts to statistical process control (SPC). This development is being supported by audits of the suppliers' manufacturing quality control systems. The keystone of quality management is the concept of customer and supplier working together for their mutual advantage. The focus in this presentation will be on two topics. (1) Fixed bed catalysts: The recognition of lot-to-lot variations led to purchase specifications which then led to quality control procedures for purchased catalysts. (2) Catalyst suppliers: the limitations of quality control for catalysts will be discussed, and the efforts of catalyst suppliers to apply SPC will be mentioned.

  1. 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.

  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. Blood typing

    MedlinePlus

    ... typing. The liquid part of your blood without cells (serum) is mixed with blood that is known to be type ... ABO typing: If your blood cells stick together when mixed with: Anti-A serum, you have type A blood Anti-B serum, you have type B blood Both anti-A and ...

  4. US Army blood program: 2025 and beyond.

    PubMed

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

    2016-03-01

    In preparing to support the Army in 2025 and beyond, the Army Blood Program remains actively engaged with the research and advanced development of blood products and medical technology to improve blood safety and efficacy in conjunction with the US Army Medical Research and Materiel Command. National and International Blood Bank authorities have noted that the US Army research and development efforts in providing new blood products and improving blood safety operate on the cutting edge of technology and are transformational for the global blood industry. Over the past 14 years, the Army has transformed how blood support is provided and improved the survival rate of casualties. Almost every product or process developed by or for the military has found an application in treating civilian patients. Conflicts have many unwanted consequences; however, in times of conflict, one positive aspect is the identification of novel solutions to improve the safety and efficacy of the blood supply. PMID:27001366

  5. 16 CFR 1101.32 - Reasonable steps to assure information is accurate.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Reasonable Steps Commission Will Take To Assure Information It Discloses Is Accurate, and That Disclosure Is..., injuries or safety-related incidents involving such a product. Such persons would include, for example, a... set forth below are the steps the Commission will take to analyze the accuracy of information which...

  6. 16 CFR 1101.33 - Reasonable steps to assure information release is fair in the circumstances.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... PRODUCT SAFETY ACT Reasonable Steps Commission Will Take To Assure Information It Discloses Is Accurate... circumstances. (a) The steps set forth below are the steps the Commission has determined are reasonable to take... information disclosed clear to the public. The Commission will also take reasonable steps to disclose...

  7. 16 CFR 1101.33 - Reasonable steps to assure information release is fair in the circumstances.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... PRODUCT SAFETY ACT Reasonable Steps Commission Will Take To Assure Information It Discloses Is Accurate... circumstances. (a) The steps set forth below are the steps the Commission has determined are reasonable to take... information disclosed clear to the public. The Commission will also take reasonable steps to disclose...

  8. 16 CFR 1101.32 - Reasonable steps to assure information is accurate.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Reasonable Steps Commission Will Take To Assure Information It Discloses Is Accurate, and That Disclosure Is..., injuries or safety-related incidents involving such a product. Such persons would include, for example, a... set forth below are the steps the Commission will take to analyze the accuracy of information which...

  9. 16 CFR 1101.33 - Reasonable steps to assure information release is fair in the circumstances.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... PRODUCT SAFETY ACT Reasonable Steps Commission Will Take To Assure Information It Discloses Is Accurate... circumstances. (a) The steps set forth below are the steps the Commission has determined are reasonable to take... information disclosed clear to the public. The Commission will also take reasonable steps to disclose...

  10. 16 CFR 1101.32 - Reasonable steps to assure information is accurate.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Reasonable Steps Commission Will Take To Assure Information It Discloses Is Accurate, and That Disclosure Is..., injuries or safety-related incidents involving such a product. Such persons would include, for example, a... set forth below are the steps the Commission will take to analyze the accuracy of information which...

  11. 16 CFR 1101.32 - Reasonable steps to assure information is accurate.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Reasonable Steps Commission Will Take To Assure Information It Discloses Is Accurate, and That Disclosure Is..., injuries or safety-related incidents involving such a product. Such persons would include, for example, a... set forth below are the steps the Commission will take to analyze the accuracy of information which...

  12. 16 CFR 1101.33 - Reasonable steps to assure information release is fair in the circumstances.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... PRODUCT SAFETY ACT Reasonable Steps Commission Will Take To Assure Information It Discloses Is Accurate... circumstances. (a) The steps set forth below are the steps the Commission has determined are reasonable to take... information disclosed clear to the public. The Commission will also take reasonable steps to disclose...

  13. 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…

  14. Blood Sugar

    MedlinePlus

    Blood sugar, or glucose, is the main sugar found in your blood. It comes from the food you eat, and is your body's main source of energy. Your blood carries glucose to all of your body's cells to use ...

  15. Blood transfusions

    MedlinePlus

    ... are many reasons you may need a blood transfusion: After knee or hip replacement surgery, or other ... your body cannot make enough blood A blood transfusion is a safe and common procedure during which ...

  16. Blood typing

    MedlinePlus

    ... whether or not there are certain proteins, called antigens, on your red blood cells. Blood is often ... There are many antigens besides the major ones (A, B, and Rh). Many minor ones are not routinely detected during blood typing. If ...

  17. Assessment of Blood Glucose Regulation and Safety of Resistant Starch Formula-Based Diet in Healthy Normal and Subjects With Type 2 Diabetes.

    PubMed

    Lin, Chia-Hung; Chang, Daw-Ming; Wu, Da-Jen; Peng, Hui-Yu; Chuang, Lee-Ming

    2015-08-01

    To evaluate the effects of the new resistant starch (RS) formula, PPB-R-203, on glucose homeostasis in healthy subjects and subjects with type 2 diabetes.A cohort consisting of 40 healthy participants received test and control diets and was checked for up to 3 hours post-meal. A randomized, 2-regimen, cross-over, comparative study was conducted in 44 subjects with type 2 diabetes and glycemic control was assessed with a continuous glucose monitoring system.In healthy participants, serum glucose values and incremental areas under the glucose curves (AUC) were significantly lower in the PPB-R-203 than the control group (P < 0.05). In patients with type 2 diabetes, mean blood glucose concentrations for subjects on the control regimen were higher than those for subjects on the PPB-R-203-based regimen (7.9 ± 1.7, 95% confidence interval [CI] 7.4-8.4 vs 7.4 ± 1.6, 95% CI 6.9-7.9 mmol/L, respectively; P = 0.023). AUCs for total blood glucose and hyperglycemia (glucose >10 mmol/L) were also reduced for subjects on the PPB-R-203-based regimen as compared with those on control regimen (total blood glucose: 16.2 ± 4.0, 95% CI 14.9-17.4 vs 18.7 ± 4.0, 95% CI 17.6-20.1, P < 0.001; hyperglycemia: 4.9 ± 5.7, 95% CI 3.1-6.6 vs 6.3 ± 6.4, 95% CI 4.3-8.3 mmol/L × day, P = 0.021). However, AUC measurements for hypoglycemia (glucose <3.9 mmol/l) were not statistically significant.A PPB-R-203-based diet reduced postprandial hyperglycemia in patients with type 2 diabetes without increasing the risk of hypoglycemia or glucose excursion. PMID:26287417

  18. Assessment of Blood Glucose Regulation and Safety of Resistant Starch Formula-Based Diet in Healthy Normal and Subjects With Type 2 Diabetes

    PubMed Central

    Lin, Chia-Hung; Chang, Daw-Ming; Wu, Da-Jen; Peng, Hui-Yu; Chuang, Lee-Ming

    2015-01-01

    Abstract To evaluate the effects of the new resistant starch (RS) formula, PPB-R-203, on glucose homeostasis in healthy subjects and subjects with type 2 diabetes. A cohort consisting of 40 healthy participants received test and control diets and was checked for up to 3 hours post-meal. A randomized, 2-regimen, cross-over, comparative study was conducted in 44 subjects with type 2 diabetes and glycemic control was assessed with a continuous glucose monitoring system. In healthy participants, serum glucose values and incremental areas under the glucose curves (AUC) were significantly lower in the PPB-R-203 than the control group (P < 0.05). In patients with type 2 diabetes, mean blood glucose concentrations for subjects on the control regimen were higher than those for subjects on the PPB-R-203-based regimen (7.9 ± 1.7, 95% confidence interval [CI] 7.4–8.4 vs 7.4 ± 1.6, 95% CI 6.9–7.9 mmol/L, respectively; P = 0.023). AUCs for total blood glucose and hyperglycemia (glucose >10 mmol/L) were also reduced for subjects on the PPB-R-203-based regimen as compared with those on control regimen (total blood glucose: 16.2 ± 4.0, 95% CI 14.9–17.4 vs 18.7 ± 4.0, 95% CI 17.6–20.1, P < 0.001; hyperglycemia: 4.9 ± 5.7, 95% CI 3.1–6.6 vs 6.3 ± 6.4, 95% CI 4.3–8.3 mmol/L × day, P = 0.021). However, AUC measurements for hypoglycemia (glucose <3.9 mmol/l) were not statistically significant. A PPB-R-203-based diet reduced postprandial hyperglycemia in patients with type 2 diabetes without increasing the risk of hypoglycemia or glucose excursion. PMID:26287417

  19. 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

  20. 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.

  1. 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…

  2. 40 CFR 194.22 - Quality assurance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...); corroborating data; confirmatory testing; or a quality assurance program that is equivalent in effect to ASME... 40 Protection of Environment 26 2012-07-01 2011-07-01 true Quality assurance. 194.22 Section 194... COMPLIANCE WITH THE 40 CFR PART 191 DISPOSAL REGULATIONS Compliance Certification and...

  3. 40 CFR 194.22 - Quality assurance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...); corroborating data; confirmatory testing; or a quality assurance program that is equivalent in effect to ASME... 40 Protection of Environment 25 2014-07-01 2014-07-01 false Quality assurance. 194.22 Section 194... COMPLIANCE WITH THE 40 CFR PART 191 DISPOSAL REGULATIONS Compliance Certification and...

  4. 40 CFR 194.22 - Quality assurance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...); corroborating data; confirmatory testing; or a quality assurance program that is equivalent in effect to ASME... 40 Protection of Environment 26 2013-07-01 2013-07-01 false Quality assurance. 194.22 Section 194... COMPLIANCE WITH THE 40 CFR PART 191 DISPOSAL REGULATIONS Compliance Certification and...

  5. 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.

  6. 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…

  7. 42 CFR 441.464 - State assurances.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Self-Directed Personal Assistance Services Program § 441.464 State assurances. A State must assure that... financial accountability for funds expended for self-directed services. (1) Safeguards must prevent the... require self-directed PAS. (3) May be eligible for self-directed PAS. (c) Notification of...

  8. 42 CFR 441.464 - State assurances.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Self-Directed Personal Assistance Services Program § 441.464 State assurances. A State must assure that... financial accountability for funds expended for self-directed services. (1) Safeguards must prevent the... require self-directed PAS. (3) May be eligible for self-directed PAS. (c) Notification of...

  9. 42 CFR 441.464 - State assurances.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Self-Directed Personal Assistance Services Program § 441.464 State assurances. A State must assure that... financial accountability for funds expended for self-directed services. (1) Safeguards must prevent the... require self-directed PAS. (3) May be eligible for self-directed PAS. (c) Notification of...

  10. 14 CFR 152.405 - Assurances.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... grantee assures that it will undertake an affirmative action program, as required by 14 CFR part 152... CFR part 152, subpart E. The grantee assures that no person shall be excluded, on these grounds, from... their suborganizations, as required by 14 CFR part 152, subpart E, to the same effect. (b)...

  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. 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....

  13. 30 CFR 74.9 - Quality assurance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... CFR part 51. Persons may obtain a copy from the International Organization for Standardization at the... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Quality assurance. 74.9 Section 74.9 Mineral... DUST SAMPLING DEVICES Requirements for Continuous Personal Dust Monitors § 74.9 Quality assurance....

  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. Quality Assurance in Chinese Higher Education

    ERIC Educational Resources Information Center

    Li, Yuan

    2010-01-01

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

  16. 18 CFR 1307.7 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 18 Conservation of Power and Water Resources 2 2010-04-01 2010-04-01 false Assurances required. 1307.7 Section 1307.7 Conservation of Power and Water Resources TENNESSEE VALLEY AUTHORITY NONDISCRIMINATION WITH RESPECT TO HANDICAP § 1307.7 Assurances required. (a) TVA contributes financial...

  17. 13 CFR 113.115 - Assurance required.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Assurance required. 113.115 Section 113.115 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION NONDISCRIMINATION IN... Introduction § 113.115 Assurance required. (a) General. Either at the application stage or the award...

  18. 38 CFR 18.4 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... property are subject to regulations issued by the Administrator of General Services (41 CFR subpart 101-6.2... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Assurances required. 18.4... THE CIVIL RIGHTS ACT OF 1964 General § 18.4 Assurances required. (a) General. (1) Every...

  19. 45 CFR 1203.5 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 4 2010-10-01 2010-10-01 false Assurances required. 1203.5 Section 1203.5 Public... Assurances required. (a) General. (1) An application for Federal financial assistance to which this part... of Federal financial assistance pursuant to the application, contain or be accompanied by,...

  20. 18 CFR 1302.5 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 18 Conservation of Power and Water Resources 2 2010-04-01 2010-04-01 false Assurances required. 1302.5 Section 1302.5 Conservation of Power and Water Resources TENNESSEE VALLEY AUTHORITY... § 1302.5 Assurances required. (a) TVA contributes financial assistance only under agreements...