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Sample records for assuring blood safety

  1. Alternative strategies in assuring blood safety: An overview.

    PubMed

    Epstein, Jay S

    2010-01-01

    Assuring transfusion safety is an essential element of health care in all countries, requiring government commitment, national policy and a legal framework. Fundamental safety strategies include selection of low risk donors, Good Manufacturing Practices in preparation of blood components, and appropriate clinical use including avoidance of unnecessary transfusions. Hemovigilance, including surveillance for known adverse events and sentinel reporting of unexpected adverse events, enhances safety through benchmarking to promote best practices and by enabling rapid responses to new threats. Preventing transmission of infectious diseases is a principal safety concern. Selection of low risk donors includes use of screening questions to elicit risk factors known to be associated with transmissible infections. Laboratory testing for specific infectious disease markers is an established strategy for interdicting contaminated donations. The sensitivity, specificity, and operational convenience of laboratory testing have improved over time and newer technologies are imminent. Donor screening and laboratory testing, while highly effective in reducing risk, cannot eliminate all risk from known agents and must be developed de novo to address emerging infections. In contrast, pathogen reduction technologies offer the possibility for robust inactivation of a broad spectrum of blood transmissible agents and provide an added safeguard against newly emerging infectious threats of most types. Current pathogen reduction methods also inactivate leukocytes, adding safety benefits similar to leukocyte removal and product irradiation. However, to date, concerns about the safety and efficacy of cellular blood components treated by pathogen reduction have prevented approval of these technologies in the U.S. and Canada. FDA is promoting clinical and basic scientific studies to clarify these issues and would consider alternative approaches to assuring blood safety if pathogen reduction

  2. Does a liberal national transfusion law assure blood safety? A survey of blood bank directors' perspectives in Lebanon.

    PubMed

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

    2013-11-01

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

  3. 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

  4. 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.

  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. 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

  7. 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

  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 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.

  11. 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.

  12. 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.

  13. 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.

  14. Assuring the quality of safety analyses and safety analysis documentation

    SciTech Connect

    J. E. Johnson

    2000-05-03

    Planning, preparation, and submittal of safety analysis reports might be pursued in a manner similar to a quality-related procurement, where customer needs, expectations and acceptance criteria are established in advance. Then the product/service provider, the contractor, should apply various quality control processes to assure the desired characteristics of the product safety analysis documents. Improving the quality and acceptability to DOE of safety documents at first submittal should result in a more expeditious DOE review and approval process, thereby reducing costs of network and recycle through reviews.

  15. Assuring the Quality of Safety Analyses and Safety Analysis Documentation

    SciTech Connect

    Johnson, John Edwin

    2000-05-01

    Planning, preparation, and submittal of safety analysis reports might be pursued in a manner similar to a quality-related procurement, where customer needs, expectations and acceptance criteria are established in advance. Then the product/service provider, the contractor, should apply various quality control processes to assure the desired characteristics of the product safety analysis documents. Improving the quality and acceptability to DOE of safety documents at first submittal should result in a more expeditious DOE review and approval process, thereby reducing costs of network and recycle through reviews.

  16. 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...

  17. Assuring nuclear plant safety before and after license renewal

    SciTech Connect

    Berto, D.S. )

    1992-01-01

    It is important in establishing a plant license renewal program that the specific goals of the program be identified at the very start. A detailed program can then be developed to focus on the stated goals, and efforts not related to accomplishing these specific goals can be excluded from the program. The goal of establishing and performing a license renewal evaluation is, of course, to obtain a renewed operating license from the US Nuclear Regulatory Commission (NRC). This goal is tied directly to the closely related goal of assuring plant safety during the license renewal term. The goal of assuring plant safety (without unnecessary costs) is the focus of the discussion in this paper. Assuring plant safety during the license renewal term is directly coupled with assuring plant safety during the current license term.

  18. 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.

  19. 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…

  20. 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.

  1. 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

  2. [The safety of blood donors].

    PubMed

    Courchelle, J; Baudry, C; Bourboul, M-C; Coudurier, N

    2011-04-01

    For a long time, safety has been patient-centred and taken for granted. Indeed, it needed a dramatic accident and the study of post-donation information for the question to be looked into again. However, under various statutory, organizational aspects and the professionalization of the staffs, safety has always accompanied the donor throughout its course of donation. Self-sufficiency is, certainly, the first mission of the Établissement Français du Sang: while we have to supply patients with sufficient blood products complying with quality criteria, we must not however forget the essential respect for the safety of the donor.

  3. 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...

  4. 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...

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

    PubMed

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

    1997-01-01

    The safety of blood transfusion has attained tremendous importance because of the problems posed by acquired immunodeficiency syndrome (AIDS) and other transfusion-transmissible diseases. While performing screening tests for human immunodeficiency virus (HIV) antibodies in donated blood is indispensable, it is also essential to introduce an effective quality assurance programme covering inspection of specimens, review of record-keeping, maintenance of equipment, and verification of results. We carried out an analysis of such quality assurance programmes during routine annual inspection of 11 blood transfusion centres in Delhi, India. The following parameters were studied: standardization of sample collection and handling; adherence to the recommended technical procedure; use of standard operating procedure; proper use of test reagents; laboratory record-keeping; proper handling of HIV-positive blood units; recording and communication of results; observation of safety guidelines; equipment quality control; and training of staff. A pretested closed-type questionnaire with a weighted scoring system was used for evaluation. Performance for each parameter was graded as follows: 76-100%, excellent; 51-75%, good; 26-50%, fair; and < 25%, poor. Centres were categorized according to the total score obtained for all parameters. Overall performance > 50% was considered satisfactory. Of the 11 centres, none was excellent overall, five were considered satisfactory, and six were unsatisfactory.

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. Safety of the blood supply in Latin America.

    PubMed

    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.

  17. SAFEGUARD: An Assured Safety Net Technology for UAS

    NASA Technical Reports Server (NTRS)

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

    2016-01-01

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

  18. 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.

  19. 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....

  20. Plant protection system to assure criticality safety in uranium extraction

    SciTech Connect

    Wilson, R.E.

    1988-01-01

    The criticality safety of uranium reprocessing at the Idaho Chemical Processing Plant depends on the control of the uranium concentration in large vessels. Many of these controls are high-quality barriers meeting the standards of a plant protective system (PPS). The first-cycle extraction PPS has been in use since 1979; the second-cycle extraction system will be equipped with a PPS shortly and the fluorinel dissolution process has had an extensive PPS since startup in 1984. The criteria for these PPSs are based on reactor development technology standard C16-IT and standard 603 of the Institute of Electrical and Electronics Engineers. These reactor plant standards were adapted and formalized for the conditions of fuel processing. The application to the first-cycle extraction operation is described in this paper. The PPS has worked reliably and effectively since its installation. Component malfunction causes inadvertent system trips less than annually. The system provides assurance of a controlled operation with little effect on productivity. As such it relieves the burden on operational supervision. In the only know PPS challenge, the CX nitric acid concentration monitor detected the results of a nitric acid leak into the makeup tank after sampling and prevented an increase in uranium concentration in the downstream mixer settler vessel.

  1. 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.

  2. 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

  3. 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…

  4. 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.

  5. [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.

  6. [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

  7. 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...

  8. Assuring Rural Hospital Patient Safety: What Should Be the Priorities?

    ERIC Educational Resources Information Center

    Coburn, Andrew F.; Wakefield, Mary; Casey, Michelle; Moscovice, Ira; Payne, Susan; Loux, Stephenie

    2004-01-01

    Context: Since reports on patient safety were issued by the Institute of Medicine, a number of interventions have been recommended and standards designed to improve hospital patient safety, including the Leapfrog, evidence-based safety standards. These standards are based on research conducted largely in urban hospitals, and it may not be possible…

  9. 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...

  10. 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).

  11. 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.

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

    SciTech Connect

    Moon, D.W.

    1988-10-01

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

  13. [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

  14. Safety aspects of cord blood banking.

    PubMed

    Warwick, R M; Barbara, J A

    1998-06-01

    The safety of cord blood for transplantation depends upon a considered approach to donor selection, testing and processing of donations. It should be undertaken within a total quality system and good manufacturing practice facilities. Protocols should be developed based upon risk assessment and cost efficiency. In this context the retesting of donors for HIV is considered and the risk of a serological window period HIV transmission by cord blood illustrated to be minimal compared to the risks of transplant procedures or of not having a donor. PMID:9712492

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

    PubMed

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

    2015-02-01

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

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

    PubMed

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

    2004-02-01

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

  17. 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…

  18. 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.

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

    SciTech Connect

    Lak Kim, C.; Yo Yun, B.; Lee, K.J.; Moon Park, S.; Wan Park, J.; Ho Choi, S.

    2007-07-01

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

  20. 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.

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. 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...

  11. 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.

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

    PubMed

    Emmanuel, Jean C

    2010-01-01

    Blood Transfusion Safety is dependent on effectively organised and managed blood services, which have adequate financial resources, skilled manpower, appropriate infrastructure and quality management systems in place. 80% of the world's population has access to 20% of the supply blood products, of which little is consistently safe. HIV highlighted the importance of blood safety. The lack of effective blood services in low human development index (LHDI), developing countries, has lead to international funding and capacity building for more than three decades. The initial strategies focused on providing HIV testing reagents to prevention transmission, however this only addresses one part of blood safety. Blood safety is not only dependent on preventing HIV transmission. In many populations there are other infectious agents, which have a higher prevalence. Ensuring the correct blood is provided to the patient depends on: well managed services with effective leadership and adequate budgets; capacity building and retention of skilled experienced staff; availability of laboratory equipment, correctly maintained; blood cold chain systems; procedures for tendering, purchasing and ensuring an unbroken supply of reagents and consumables; and quality management systems. Barriers for simplified effective tendering, procurement and contracting require urgent attention and coordination of all funding organisations to ensure an unbroken supply of reagents. PMID:20079663

  13. 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.

  14. [Blood transfusion - safety of the inventory].

    PubMed

    Tissot, Jean-Daniel; Danic, Bruno; Schneider, Thierry

    2015-02-01

    Over the years, transfusion medicine has been faced to many different problems, notably those related to transmission of pathogens. Major progresses have been accomplished in terms of security. However, nowadays, the discipline is confronted to the day-to-day variability and availability of blood products. More and more donors are excluded from blood donation due to various reasons, and the donor selection criteria have increased over the years, influencing the number of donors able to give blood. This paradox represents one of the constraints that transfusion medicine should resolve in the future. This paper presents some aspects either common or different between France and Switzerland.

  15. 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.

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

    NASA Technical Reports Server (NTRS)

    Anderson, Joel M.

    2011-01-01

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

  17. 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.

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

    NASA Technical Reports Server (NTRS)

    Withrow, Colleen A.; Reveley, Mary S.

    2015-01-01

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

  19. 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)

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

    PubMed

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

    1990-01-01

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

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

    PubMed

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

    2013-08-01

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

  2. 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.

  3. Interdisciplinary process improvement for enhancing blood transfusion safety.

    PubMed

    LaRocco, Mark; Brient, Kathy

    2010-01-01

    We describe a multipronged, multidisciplinary effort to improve the safety of blood transfusion in our hospital. System-wide practices related to the ordering, delivery, and transfusion of blood products were addressed including: (1) appropriate selection of patients and utilization of blood, (2) accurate blood product labeling and tracking, (3) reliable transportation of blood products between the transfusion service laboratory and the bedside, (4) electronic verification of patients and products at the point of transfusion, and (5) documentation of transfusion events in the patient's medical record. By implementing new technologies and focusing LEAN process improvement techniques on the preanalytical, analytical, and postanalytical phases of the transfusion cycle, we have been able to significantly reduce the risk of transfusion error in our patient population.

  4. 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.

  5. 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

  6. 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

    ... FURTHER INFORMATION CONTACT: Mr. James Berger, Senior Advisor for Blood and Tissue Safety Policy, Office..., 2013. James J. Berger, Senior Advisor for Blood and Tissue Safety Policy. BILLING CODE 4150-41-P...

  7. 75 FR 28619 - Meeting of the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-21

    ... availability of the blood supply and blood products, (2) broad public health, ethical and legal issues related to transfusion and transplantation safety, and (3) the implications for safety and the...

  8. 75 FR 71444 - Renewal of Charter for the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-23

    ... and availability of the blood and blood products; (2) broad public health, ethical, and legal issues related to transfusion and transplantation safety; and (3) implications for safety and availability...

  9. 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...

  10. 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...

  11. 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...

  12. Safety of blood donations following a natural disaster.

    PubMed

    Busch, M P; Guiltinan, A; Skettino, S; Cordell, R; Zeger, G; Kleinman, S

    1991-10-01

    To evaluate the relative safety of blood donations given in response to a major disaster, donor demographics and infectious disease test results were compared for donations made during the 10 days following the October 17, 1989, San Francisco Bay Area earthquake and those made during the preceding 6 months. These comparisons were made for donations given to the regional blood center in the area that was immediately affected by the disaster (Irwin Memorial Blood Centers) and for those given in an unaffected region (Los Angeles/Orange Counties Region, American Red Cross Blood Services). The rate of donation increased more than 200 percent during the 5 days following the earthquake in both the disaster-affected and unaffected regions. Both the disaster-affected and unaffected regions observed significant increases in the proportions of donations by first-time donors, by persons aged 20 to 39 years, and by women. The rates of confirmed positivity for infectious disease markers for post-earthquake donations did not differ significantly from rates for homologous donations given during the preceding 6 months, particularly when the rates were adjusted for the increased representation of first-time donors. Approximately 39 percent of post-earthquake first-time donors gave blood again within the following 6-month period. It is concluded that donations given after major disasters are essentially as safe as routine donations and that active efforts to recruit these donors again can be undertaken without reservation.

  13. 49 CFR Appendix C to Part 236 - Safety Assurance Criteria and Processes

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    .... (iii) N-version programming concept. This concept requires a processor-based product to use at least... for Safety Validation of Computer Controlled Subsystems. Volume II: Development of a Safety...

  14. 49 CFR Appendix C to Part 236 - Safety Assurance Criteria and Processes

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    .... (iii) N-version programming concept. This concept requires a processor-based product to use at least... for Safety Validation of Computer Controlled Subsystems. Volume II: Development of a Safety...

  15. 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…

  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. 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.

  18. 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.

  19. 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.

  20. 76 FR 68192 - Meeting of the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-03

    ... CONTACT: Mr. James Berger, Acting Executive Secretary, ACBSA, Office of the Assistant Secretary for Health.... Berger, Acting Executive Secretary, Advisory Committee on Blood Safety and Availability. BILLING...

  1. 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

  2. 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.

  3. 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

  4. Perceived safety of donor blood and blood substitutes for transfusion: the role of informational frame, patient groups and stress appraisals.

    PubMed

    Ferguson, E; Leaviss, J; Townsend, E; Fleming, P; Lowe, K C

    2005-10-01

    Patients express concerns about the safety of donated blood. Do they have similar concerns about potential 'blood substitutes' and does the way information is presented on these options alter patients' perceptions? A two (informational frame: gain or loss) by four (transfusion type: human donor blood, human haemoglobin, bovine haemoglobin or perfluorocarbon emulsion substitutes) by three (patient group: adult haemophiliac/leukaemia patients, relatives/friends of haemophiliac/leukaemia patients and controls) between-subjects design was used. There were 82 patients, 118 relatives/friends and 263 controls from the UK. Blood substitutes were perceived as being significantly less safe than donor blood. Perceptions of safety were greater when transfusion information (regardless of transfusion type or patient group) was presented as gains rather than losses. Different demographic and psychological factors predicted perceived safety (e.g. sex) and perceived risk (e.g. age and experience).

  5. 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.

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

    PubMed

    Cockburn, Andrew

    2002-09-11

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

  7. 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

  8. 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

  9. Substantial Improvements in Performance Indicators Achieved in a Peripheral Blood Mononuclear Cell Cryopreservation Quality Assurance Program Using Single Donor Samples▿

    PubMed Central

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

    2007-01-01

    Storage of high-quality cryopreserved peripheral blood mononuclear cells (PBMC) is often a requirement for multicenter clinical trials and requires a reproducibly high standard of practice. A quality assurance program (QAP) was established to assess an Australia-wide network of laboratories in the provision of high-quality PBMC (determined by yield, viability, and function), using blood taken from single donors (human immunodeficiency virus [HIV] positive and HIV negative) and shipped to each site for preparation and cryopreservation of PBMC. The aim of the QAP was to provide laboratory accreditation for participation in clinical trials and cohort studies which require preparation and cryopreservation of PBMC and to assist all laboratories to prepare PBMC with a viability of >80% and yield of >50% following thawing. Many laboratories failed to reach this standard on the initial QAP round. Interventions to improve performance included telephone interviews with the staff at each laboratory, two annual wet workshops, and direct access to a senior scientist to discuss performance following each QAP round. Performance improved substantially in the majority of sites that initially failed the QAP (P = 0.002 and P = 0.001 for viability and yield, respectively). In a minority of laboratories, there was no improvement (n = 2), while a high standard was retained at the laboratories that commenced with adequate performance (n = 3). These findings demonstrate that simple interventions and monitoring of PBMC preparation and cryopreservation from multiple laboratories can significantly improve performance and contribute to maintenance of a network of laboratories accredited for quality PBMC fractionation and cryopreservation. PMID:17050740

  10. Performance review of the National Blood Safety Improvement Project in Korea (2004-2009)

    PubMed Central

    Kim, Sinyoung; Kim, Moon Jung; Lee, Sang Won; Shin, Young Hack; Choi, Young Sil; Lee, Dong Han

    2013-01-01

    Background In 2004, the Korean government and blood transfusion community deliberated on the issue of a national blood system reform and agreed to implement a 5-year project (2004-2009) to further improve safety measures. Our study delineates the basis of the current national blood program and analyzes the performance of this 5-year project initiated by the Korean government. Methods A performance review of the 5-year project was conducted from May 2009 to February 2010 using various approaches. Numerous data and documentation were collected from the Korean Red Cross and the Korean Centers for Disease Control and Prevention and reviewed by experts. Approximately 20 interviews with representatives of stakeholder groups were conducted to gather information, opinions, and perceptions. We conducted a nationwide field survey on a total of 144 blood donor centers. Results Among the 5 major categories of the 5-year project, blood donor recruitment, laboratory testing, and product manufacturing were improved in terms of quality performance. Specifically, government's financial support ensured that the infrastructure of blood donor centers and blood laboratory centers improved. The pivotal role of the government contributed to improvements in the national blood program and enhanced national surveillance for blood safety. Conclusion Korea has made a tremendous effort with positive outcomes to provide safety measures for blood products for transfusion in its citizens. In all areas of blood management, from blood donations to transfusions, continuous developments in monitoring safety standards and practices are paramount. PMID:23826584

  11. Optical biosensors for food quality and safety assurance-a review.

    PubMed

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

    2012-08-01

    Food quality and safety is a scientific discipline describing handling, preparation and storage of food in ways that prevent food borne illness. Food serves as a growth medium for microorganisms that can be pathogenic or cause food spoilage. Therefore, it is imperative to have stringent laws and standards for the preparation, packaging and transportation of food. The conventional methods for detection of food contamination based on culturing, colony counting, chromatography and immunoassay are tedious and time consuming while biosensors have overcome some of these disadvantages. There is growing interest in biosensors due to high specificity, convenience and quick response. Optical biosensors show greater potential for the detection of pathogens, pesticide and drug residues, hygiene monitoring, heavy metals and other toxic substances in the food to check whether it is safe for consumption or not. This review focuses on optical biosensors, the recent developments in the associated instrumentation with emphasis on fiber optic and surface plasmon resonance (SPR) based biosensors for detecting a range of analytes in food samples, the major advantages and challenges associated with optical biosensors. It also briefly covers the different methods employed for the immobilization of bio-molecules used in developing biosensors. PMID:23904648

  12. Optical biosensors for food quality and safety assurance-a review.

    PubMed

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

    2012-08-01

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

  13. 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.

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

    PubMed

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

    2004-06-01

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

  15. 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

  16. 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.

  17. 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.

  18. 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.

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

    PubMed Central

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

    2015-01-01

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

  20. 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.

  1. 76 FR 76732 - Nominations to the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-08

    ... Mr. James Berger, Acting Director, Blood Safety and Availability, Office of the Assistant Secretary..., consultancies, and research grants and/or contracts. Dated: November 30, 2011. James J. Berger,...

  2. Investments in blood safety improve the availability of blood to underserved areas in a sub-Saharan African country

    PubMed Central

    Pitman, J. P.; Wilkinson, R.; Basavaraju, S. V.; von Finckenstein, B.; Sibinga, C. Smit; Marfin, A. A.; Postma, M. J.; Mataranyika, M.; Tobias, J.; Lowrance, D. W.

    2015-01-01

    Background and Objectives Since 2004, several African countries, including Namibia, have received assistance from the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). Gains have been documented in the safety and number of collected units in these countries, but the distribution of blood has not been described. Materials and Methods Nine years of data on blood requests and issues from Namibia were stratified by region to describe temporal and spatial changes in the number and type of blood components issued to Namibian healthcare facilities nationally. Results Between 2004 and 2007 (early years of PEPFAR support) and 2008–2011 (peak years of PEPFAR support), the average number of red cell units issued annually increased by 23.5% in seven densely populated but less-developed regions in northern Namibia; by 30% in two regions with urban centres; and by 35.1% in four sparsely populated rural regions. Conclusion Investments in blood safety and a policy decision to emphasize distribution of blood to underserved regions improved blood availability in remote rural areas and increased the proportion of units distributed as components. However, disparities persist in the distribution of blood between Namibia’s urban and rural regions. PMID:26478742

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

    PubMed

    Schmitt, H

    1994-01-01

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

  4. 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).

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

    PubMed

    Ilinskaya, Anna N; Dobrovolskaia, Marina A

    2013-06-01

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

  6. 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

  7. 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.

  8. 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.

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

    PubMed

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

    2016-05-01

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

  10. 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

  11. 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.

  12. 76 FR 26300 - Meeting of the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-06

    ... human origin for transplantation will be solicited. In addition, the Committee will be asked for... HUMAN SERVICES Meeting of the Advisory Committee on Blood Safety and Availability AGENCY: Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health....

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-22

    ... below. ADDRESSES: All nominations should be mailed or delivered to Mr. James Berger, Associate Public...) 453-8803. FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Associate Public Health Advisor for Blood, Organ and Tissue Safety. Contact information for Mr. Berger is provided above. A copy of the...

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

    PubMed

    Custer, Brian; Janssen, Mart P

    2015-08-01

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

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

    PubMed

    Busby, Helen; Kent, Julie; Farrell, Anne-Maree

    2014-01-01

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

  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. Post-thaw viability of cryopreserved peripheral blood stem cells (PBSC) does not guarantee functional activity: important implications for quality assurance of stem cell transplant programmes.

    PubMed

    Morgenstern, Daniel A; Ahsan, Gulrukh; Brocklesby, Margaret; Ings, Stuart; Balsa, Carmen; Veys, Paul; Brock, Penelope; Anderson, John; Amrolia, Persis; Goulden, Nicholas; Cale, Catherine M; Watts, Michael J

    2016-09-01

    Standard quality assurance (QA) of cryopreserved peripheral blood stem cells (PBSC) uses post-thaw viable CD34(+) cell counts. In 2013, concerns arose at Great Ormond Street Hospital (GOSH) about 8 patients with delayed engraftment following myeloablative chemotherapy with cryopreserved cell rescue, despite adequate post-thaw viable cell counts in all cases. Root cause analysis was undertaken; investigations suggested the freeze process itself was a contributing factor to suboptimal engraftment. Experiments were undertaken in which a single PBSC product was divided into three and cryopreserved in parallel using a control-rate freezer (CRF) or passive freezing method (-80°C freezer) at GOSH, or the same passive freezing at another laboratory. Viable CD34(+) counts were equivalent and adequate in each. Granulocyte-monocyte colony-forming unit assays demonstrated colonies from the products cryopreserved using passive freezing (both laboratories), but no colonies from products cryopreserved using the CRF. The CRF was shown to be operating within manufacturer's specifications with freeze-profile within acceptable limits. This experience has important implications for quality assurance for all transplant programmes, particularly those using cryopreserved products. The failure of post-thaw viable CD34(+) counts, the most widely used routine QA test available, to ensure PBSC function is of great concern and should prompt reassessment of protocols and QA procedures. PMID:27291859

  18. Post-thaw viability of cryopreserved peripheral blood stem cells (PBSC) does not guarantee functional activity: important implications for quality assurance of stem cell transplant programmes.

    PubMed

    Morgenstern, Daniel A; Ahsan, Gulrukh; Brocklesby, Margaret; Ings, Stuart; Balsa, Carmen; Veys, Paul; Brock, Penelope; Anderson, John; Amrolia, Persis; Goulden, Nicholas; Cale, Catherine M; Watts, Michael J

    2016-09-01

    Standard quality assurance (QA) of cryopreserved peripheral blood stem cells (PBSC) uses post-thaw viable CD34(+) cell counts. In 2013, concerns arose at Great Ormond Street Hospital (GOSH) about 8 patients with delayed engraftment following myeloablative chemotherapy with cryopreserved cell rescue, despite adequate post-thaw viable cell counts in all cases. Root cause analysis was undertaken; investigations suggested the freeze process itself was a contributing factor to suboptimal engraftment. Experiments were undertaken in which a single PBSC product was divided into three and cryopreserved in parallel using a control-rate freezer (CRF) or passive freezing method (-80°C freezer) at GOSH, or the same passive freezing at another laboratory. Viable CD34(+) counts were equivalent and adequate in each. Granulocyte-monocyte colony-forming unit assays demonstrated colonies from the products cryopreserved using passive freezing (both laboratories), but no colonies from products cryopreserved using the CRF. The CRF was shown to be operating within manufacturer's specifications with freeze-profile within acceptable limits. This experience has important implications for quality assurance for all transplant programmes, particularly those using cryopreserved products. The failure of post-thaw viable CD34(+) counts, the most widely used routine QA test available, to ensure PBSC function is of great concern and should prompt reassessment of protocols and QA procedures.

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

    PubMed

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

    2013-05-01

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

  20. Quality assurance of metabolomics.

    PubMed

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

    2015-01-01

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

  1. 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

  2. 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.

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

    PubMed

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

    2007-03-01

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

  4. 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.

  5. Proceedings of a consensus conference: Risk-Based Decision Making for Blood Safety.

    PubMed

    Leach Bennett, Judie; Blajchman, Morris A; Delage, Gilles; Fearon, Margaret; Devine, Dana

    2011-10-01

    Blood safety decision making has become increasingly complex, and a framework for risk-based decision making is, thus, needed. The purpose of this consensus conference was to bring together international experts in an effort to develop the foundations for such a framework. These proceedings are described with a view to making available to the transfusion medicine community the considerable amount of information and insight that was presented and that emerged through debate by the experts, panel members, and delegates.

  6. Proceedings of a consensus conference: Risk-Based Decision Making for Blood Safety.

    PubMed

    Leach Bennett, Judie; Blajchman, Morris A; Delage, Gilles; Fearon, Margaret; Devine, Dana

    2011-10-01

    Blood safety decision making has become increasingly complex, and a framework for risk-based decision making is, thus, needed. The purpose of this consensus conference was to bring together international experts in an effort to develop the foundations for such a framework. These proceedings are described with a view to making available to the transfusion medicine community the considerable amount of information and insight that was presented and that emerged through debate by the experts, panel members, and delegates. PMID:21763103

  7. 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…

  8. [Blood Safety in the XXI century. Transfusion transmitted infectious diseases. International and Mexican view].

    PubMed

    Rojo Medina, Julieta

    2014-01-01

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

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

    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.

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

    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.

  11. 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.

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 10 CFR 830.121 - Quality Assurance Program (QAP).

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ...) Integrate the quality assurance criteria with the Safety Management System, or describe how the quality assurance criteria apply to the Safety Management System. (3) Use voluntary consensus standards in its... Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.121...

  18. 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

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

    PubMed

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

    2013-03-01

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

  20. The margin of safety in the use of a straight path centrifugal blood pump.

    PubMed

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

    1994-09-01

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

  1. Blood safety and the choice of anti-hemophilic factor concentrate.

    PubMed

    Valentino, Leonard A; Oza, Veeral M

    2006-09-01

    Hemophilia is a congenital disorder due to the deficiency of the activity of factor VIII (classical hemophilia A) or IX (Christmas disease or hemophilia B). Bleeding is common and may result in long-term complications or even death. Bleeding may be treated or prevented by infusion of factor concentrates however these drugs are not without risk. Clinicians often feel ill prepared to provide accurate and impartial information regarding these drugs. This review will provide the reader with an historical yet up to date perspective on blood safety as it relates to the choice of concentrates to treat hemophilia.

  2. 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

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

    PubMed

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

    2006-02-01

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

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

    PubMed

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

    2006-07-01

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

  5. NASA's Approach to Software Assurance

    NASA Technical Reports Server (NTRS)

    Wetherholt, Martha

    2015-01-01

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

  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. Quality assurance.

    PubMed

    Hannan, T

    1991-01-01

    Modern health care is changing--we have more chronic disease, increasing demands for documentation from government and legal bodies, and greater emphasis on disease screening and prevention. Quality assurance is important in developing health care services to meet these changing needs because it provides standards by which we can measure the activities involved in the delivery of health care, and quality assurance programmes are more likely to ensure that the predefined standards of health care are being met. This paper provides: (i) an acceptable definition of quality assurance (QA); (ii) an explanation of why we need it; (iii) evidence that the medical decision-making process is failing under the modern technological advances; and (iv) guidelines for meeting future health care standards by using the modern technological tools of computers and computer software to support the beleaguered clinical decision-making process.

  8. Safety of human blood products: inactivation of retroviruses by heat treatment at 60 degrees C.

    PubMed

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

    1985-04-01

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

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

    PubMed

    Cheung, Tommy Tsang; Cheung, Bernard Man Yung

    2014-01-01

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

  10. 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.

  11. [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.

  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. 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

  14. 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.

  15. Evaluation of the Efficacy and Safety of Rivaroxaban Using a Computer Model for Blood Coagulation

    PubMed Central

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

    2011-01-01

    Rivaroxaban is an oral, direct Factor Xa inhibitor approved in the European Union and several other countries for the prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery and is in advanced clinical development for the treatment of thromboembolic disorders. Its mechanism of action is antithrombin independent and differs from that of other anticoagulants, such as warfarin (a vitamin K antagonist), enoxaparin (an indirect thrombin/Factor Xa inhibitor) and dabigatran (a direct thrombin inhibitor). A blood coagulation computer model has been developed, based on several published models and preclinical and clinical data. Unlike previous models, the current model takes into account both the intrinsic and extrinsic pathways of the coagulation cascade, and possesses some unique features, including a blood flow component and a portfolio of drug action mechanisms. This study aimed to use the model to compare the mechanism of action of rivaroxaban with that of warfarin, and to evaluate the efficacy and safety of different rivaroxaban doses with other anticoagulants included in the model. Rather than reproducing known standard clinical measurements, such as the prothrombin time and activated partial thromboplastin time clotting tests, the anticoagulant benchmarking was based on a simulation of physiologically plausible clotting scenarios. Compared with warfarin, rivaroxaban showed a favourable sensitivity for tissue factor concentration inducing clotting, and a steep concentration–effect relationship, rapidly flattening towards higher inhibitor concentrations, both suggesting a broad therapeutic window. The predicted dosing window is highly accordant with the final dose recommendation based upon extensive clinical studies. PMID:21526168

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

    PubMed

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

    2011-01-01

    Rivaroxaban is an oral, direct Factor Xa inhibitor approved in the European Union and several other countries for the prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery and is in advanced clinical development for the treatment of thromboembolic disorders. Its mechanism of action is antithrombin independent and differs from that of other anticoagulants, such as warfarin (a vitamin K antagonist), enoxaparin (an indirect thrombin/Factor Xa inhibitor) and dabigatran (a direct thrombin inhibitor). A blood coagulation computer model has been developed, based on several published models and preclinical and clinical data. Unlike previous models, the current model takes into account both the intrinsic and extrinsic pathways of the coagulation cascade, and possesses some unique features, including a blood flow component and a portfolio of drug action mechanisms. This study aimed to use the model to compare the mechanism of action of rivaroxaban with that of warfarin, and to evaluate the efficacy and safety of different rivaroxaban doses with other anticoagulants included in the model. Rather than reproducing known standard clinical measurements, such as the prothrombin time and activated partial thromboplastin time clotting tests, the anticoagulant benchmarking was based on a simulation of physiologically plausible clotting scenarios. Compared with warfarin, rivaroxaban showed a favourable sensitivity for tissue factor concentration inducing clotting, and a steep concentration-effect relationship, rapidly flattening towards higher inhibitor concentrations, both suggesting a broad therapeutic window. The predicted dosing window is highly accordant with the final dose recommendation based upon extensive clinical studies. PMID:21526168

  17. Training with blood flow restriction. Mechanisms, gain in strength and safety.

    PubMed

    Heitkamp, H C

    2015-05-01

    Blood flow restriction training has proven to be effective, but it is not well known and is limited by initially producing discomfort. Blood flow restriction (BFR) induces hypoxia and metabolic effects, as well as reduction of proteolysis and induction of anabolic processes. Growth hormone levels are regularly increased. Controversies exist concerning neuromuscular effects. Twenty-eight of 30 studies, showed an increase in strength usually associated with muscle hypertrophy in both men and women, although data for women are sparse. Initial reports exist on positive effects on bone health after measuring rises in bone markers. A gain in strength has also been reported in non-occluded muscles after BFR training. BFR without training can lead to a rise in strength and reduce atrophy in knee extensor muscles during immobilisation. Controversial results have been observed concerning changes in aerobic capacity. Up to now no standard BFR training guidelines exist. Occlusion pressure, intensity of training, number of sets and duration of a training unit remain unclear. Presently, an occlusion pressure of 150 mmHg may be recommended with an intensity of 20 % 1-repetition maximum (1 RM), and wider cuffs are more efficient than narrow ones. Between training sets BFR should be continued. Rheologic investigations after BFR have shown no evidence for increased risk of thrombosis, when studying possible contraindications. Safety aspects for older patients must be more thoroughly addressed. The low-intensity needed may establish this training method in cardiac and pulmonary patients after future research.

  18. 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...

  19. 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...

  20. 10 CFR 830.122 - Quality assurance criteria.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 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...

  1. Quality assurance in the ambulatory care setting.

    PubMed

    Tyler, R D

    1989-01-01

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

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

    PubMed

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

    2013-12-01

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

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

    PubMed

    Seghatchian, Jerard

    2015-04-01

    This brief paper is based on the Coimbra 'conference presentation by the moderator', prior to the two main lectures on pathogen reduction treatment [PRT] of plasma. Being an educationist and teacher in core and having a great interest to simplify the message convey to conference' participants and readers I decided to maintain the slide format of the presentation. To highlight most effectively the role played by pathogen reduction to supplement the multilayer-strategy already in place, emphasizes were placed by going back to basic focusing on: where we were, where we are now and where we are going!. The unresolved problems of viral safety of blood components and criteria of universal acceptability of PRT are highlighted so is the need for further DDR strategies both in incremental and innovative ways. Finally the issue of who would benefit from implementation of PRT is described based on published data and also providing some visionary foresights for the long term benefits of PRT in both optimizing the safety of blood supply and helping at least in health care containment. I hope this new approach will be useful to readers, providing at least some conceptual and technical supports in understanding the role of PRT in optimizing the safety of blood supply. PMID:25748230

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

    PubMed

    Seghatchian, Jerard

    2015-04-01

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

  5. 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

  6. 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...

  7. 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...

  8. 30 CFR 7.7 - Quality assurance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  9. 30 CFR 15.8 - Quality assurance.

    Code of Federal Regulations, 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...

  10. Safety and Feasibility of Achieving Lower Systolic Blood Pressure Goals in Persons With Type 2 Diabetes: The SANDS Trial

    PubMed Central

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

    2009-01-01

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

  11. 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

  12. 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 ...

  13. 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 ...

  14. 75 FR 61143 - Meeting of the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-04

    ... public health, ethical and legal issues related to transfusion and transplantation safety, and (3) the... recommendations including elements of a strategic plan for transfusion and transplantation safety. The review is intended to align the transfusion and transplantation safety initiatives to the Secretary's...

  15. 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…

  16. 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.

  17. 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

    ..., Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Senior Advisor for Blood Policy and...: November 2, 2012. James J. Berger, Senior Advisor for Blood Policy, Executive Secretary ACBTSA....

  18. 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 Assurance Program (QAP). (a) Contractors conducting activities, including providing items or services, that affect, or may affect, the...

  19. 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...

  20. 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

  1. 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

  2. 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

    ..., Rockville, MD, 20852. FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Designated Federal Officer, ACBTSA..., 2013. James J. Berger, Designated Federal Official, ACBTSA and Senior Advisor for Blood and...

  3. 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.

  4. 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

  5. 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

    ... on the basis of race, color or national origin (and 49 CFR Part 21); (b) Title IX of the Education..., 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...

  6. 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

    ... on the basis of race, color or national origin (and 49 CFR Part 21); (b) Title IX of the Education..., 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...

  7. Beef Quality Assurance in Feedlots.

    PubMed

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

    2015-07-01

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

  8. 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

  9. 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

  10. 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.

  11. 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

  12. 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

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

    PubMed Central

    Porcella, Aleta; Walker, Kristy

    2005-01-01

    Supported by a grant from the Agency for Healthcare Research and Quality, a University of Iowa Hospitals and Clinics interdisciplinary research team created an online data-capture-response tool utilizing wireless mobile devices and bar code technology to track and improve blood products administration process. The tool captures 1) sample collection, 2) sample arrival in the blood bank, 3) blood product dispense from blood bank, and 4) administration. At each step, the scanned patient wristband ID bar code is automatically compared to scanned identification barcode on requisition, sample, and/or product, and the system presents either a confirmation or an error message to the user. Following an eight-month, 5 unit, staged pilot, a ‘big bang,’ hospital-wide implementation occurred on February 7, 2005. Pilot period and preliminary house-wide data indicate improved error capture with the new barcode process over the old manual process. PMID:16779113

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

    PubMed

    Porcella, Aleta; Walker, Kristy

    2005-01-01

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

  15. Challenges in High-Assurance Runtime Verification

    NASA Technical Reports Server (NTRS)

    Goodloe, Alwyn E.

    2016-01-01

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

  16. Half a decade of mini-pool nucleic acid testing: Cost-effective way for improving blood safety in India

    PubMed Central

    Chandrashekar, Shivaram

    2014-01-01

    Background and Objectives: It is well established that Nucleic acid testing (NAT) reduces window phase of transfusion transmissible infections (TTI) and helps improve blood safety. NAT testing can be done individually or in pools. The objectives of this study were to determine the utility, feasibility and cost effectiveness of an in-house minipool-NAT(MP-NAT). Materials and Methods: Blood donors were screened by history, tested by ELISA and sero-negative samples were subjected to an in-house NAT by using reverse transcriptase-polymerase chain reaction (RT-PCR). Testing was done in mini-pools of size eight (8). Positive pools were repeated with individual samples. Results: During the study period of Oct 2005-Sept 2010 (5 years) all blood donors (n=53729) were screened by ELISA. Of which 469 (0.87%) were positive for HIV-1, HBV or HCV. Sero-negative samples (n=53260) were screened by in-house MP-NAT. HIV-NAT yield was 1/53260 (n=1) and HBV NAT yield (n=2) was 1/26630. Conclusion: NAT yield was lower than other India studies possibly due to the lower sero-reactivity amongst our donors. Nevertheless it intercepted 9 lives including the components prepared. The in-house assay met our objective of improving blood safety at nominal cost and showed that it is feasible to set up small molecular biology units in medium-large sized blood banks and deliver blood within 24-48 hours. The utility of NAT (NAT yield) will vary based on the donor population, the type of serological test used, the nature of kit employed and the sensitivity of NAT test used. The limitations of our in-house MP-NAT consisted of stringent sample preparation requirements, with labor and time involved. The benefits of our MP-NAT were that it acted as a second level of check for ELISA tests, was relatively inexpensive compared to ID-NAT and did not need sophisticated equipment. PMID:24678172

  17. 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)

  18. 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.

  19. 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…

  20. 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.

  1. 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.

  2. 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.

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

    ClinicalTrials.gov

    2016-09-21

    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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-21

    ... address listed below. ADDRESSES: All nominations should be mailed or delivered to Mr. James Berger, Senior... INFORMATION CONTACT: Mr. James Berger, Senior Advisor for Blood Policy. Contact information for Mr. Berger is... contacting Mr. Berger or by accessing the ACBTSA Web site at...

  5. 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.

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

    SciTech Connect

    Khericha, Soli T

    2002-06-01

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

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

    PubMed

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

    2013-05-01

    Daidzein, an estrogen-like product, becomes increasingly popular as a dietary supplement, particularly for postpeak-estrus animals seeking a safe natural alternative to play a role of estrogen. However, there is little available safety data of it for raisers and consumers. A subchronic laying hen safety study was conducted to examine if the high-dose daidzein could affect the safety of hens selves, including laying performance, clinical blood parameters and organs development. Seven hundred and sixty-eight 56-week-old Hyline Brown were randomly assigned to 4 groups with 8 replicates of 24 birds each and 3weeks later fed diets supplemented with 0, 10, 50 and 100mg of daidzein/kg for 12weeks. The mortality was significantly decreased (P<0.05). No treatment related adverse clinical signs were observed. Mean egg production, egg mass and feed conversion of whole experiment period was significantly influenced by dietary daidzein supplement (P<0.05), showing significant quadratic response to increasing dietary daidzein supplement (P=0.029, P=0.003 and P=0.019, respectively). There was no statistically significant changes in haematology (P>0.05). In clinical chemistry parameters, total protein, total cholesterol, calcium and phosphorus were significantly affected by dietary daidzein supplement (P<0.05). The no observed adverse effect level (NOAEL) is considered to be 50mg/kg. PMID:23391597

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

    PubMed Central

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

    2016-01-01

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

  9. 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

  10. Safety and efficiency considerations for the introduction of electronic ordering in a blood bank.

    PubMed

    Georgiou, Andrew; Greenfield, Tony; Callen, Joanne; Westbrook, Johanna I

    2009-06-01

    The introduction of computerized provider order entry (CPOE) systems is associated with major changes in work processes. Implementation strategies need to consider how the technology will affect and be affected by the organization in which it is being installed. The aim of this study was to examine the potential effect of the introduction of a CPOE system on key work processes in a hospital blood bank by using qualitative data from focus groups, interviews, and participant observation and quantitative data of telephone communication. We found that work practices in the blood bank are made up of a mosaic of collaborative processes underpinned by communication channels to facilitate safe and efficient work practices. The introduction of CPOE systems requires consideration of these channels and of the ways that CPOE may disrupt existing communication processes. There needs to be high levels of staff preparedness to minimize patient risk and optimize performance.

  11. 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

  12. 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.

  13. 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.

  14. 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

  15. [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

  16. Hyperthermia quality assurance results.

    PubMed

    Shrivastava, P N; Saylor, T K; Matloubieh, A Y; Paliwal, B R

    1988-01-01

    The Hyperthermia Physics Center (HPC), under contract with the National Cancer Institute (NCI), has conducted review-type quality assurance (QA) measurements at the five Hyperthermia Equipment Evaluation Centers involved in evaluating the clinical efficacy of a variety of devices for delivering heat treatments to deep-seated human tumours. A summary of the QA protocol, results, testing procedures, standards, criteria, conclusions and recommendations are presented in this paper. The QA review measurements indicate (a) that 81.5 per cent of temperatures surveyed were within the 0.2 degrees C HPC criterion (91 per cent were within 0.4 degrees C), (b) that only 66 per cent of power indications were within the 10 per cent criterion, (c) that the heat patterns in a phantom produced by the BSD Annular Phased Array (AA) had significant variability, (d) that each treatment facility had at least a few potentially occupiable locations where the maximum permissible American National Standards Institute standards of electromagnetic leakage were exceeded, and (e) that these levels of accuracy and safety were achieved only after stringent inhouse QA efforts. From the combined data, it is concluded that the temperature accuracy in this cooperative trial was sufficient to justify a common analysis of clinical data as presented in this series. Also, stringent quality control of every parameter must continue to be stressed in all future hyperthermia trials.

  17. 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

  18. 20 CFR 655.203 - Assurances.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 20 Employees' Benefits 3 2011-04-01 2011-04-01 false Assurances. 655.203 Section 655.203 Employees' Benefits EMPLOYMENT AND TRAINING ADMINISTRATION, DEPARTMENT OF LABOR TEMPORARY EMPLOYMENT OF FOREIGN... laws, including employment related health and safety laws; (c) The job opportunity is open to...

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

    PubMed

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

    2016-02-01

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

  1. 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.

  2. 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.

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

    PubMed

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

    1994-01-01

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

  4. Technical note: preventive maintenance quality assurance.

    PubMed

    Russell, D

    1992-01-01

    Performance improvements in healthcare and, specifically, in clinical engineering are required by the Joint Commission on the Accreditation of Healthcare Organizations' Plant Technology and Safety Management (PTSM) documents. The goals of healthcare service quality assurance are to establish performance requirements and improve patient outcomes. It is important that these goals be kept in the forefront of the design of clinical engineering quality assurance planning. Indicator/threshold pairs must be carefully chosen on the basis of some logical relation to the desired goals of the overall program. PMID:10120060

  5. 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.

  6. 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.

  7. 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).

  8. 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.

  9. Assuring safety in the National Ignition Facility

    SciTech Connect

    Becker, D R; Brereton, S J; Brumburgh, G P; Pryatel, J A; Wolfe, C R; Yatabe, J M

    1998-04-28

    The National Ignition Facility (NIF) is a US Department of Energy inertial confinement laser fusion facility currently under construction at the Lawrence Livermore National Laboratory (LLNL). The NIF mission is to achieve inertial confinement fusion (ICF) ignition, access physical conditions in matter of interest to nuclear weapons effects testing, contribute to the development of inertial fusion for electrical power production, and to support basic science and technology.

  10. 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.

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

    NASA Technical Reports Server (NTRS)

    Canfield, Amy

    2016-01-01

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

  12. 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 ...

  13. [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.

  14. Quality Assurance: Patient Chart Reviews

    NASA Astrophysics Data System (ADS)

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

    2009-07-01

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

  15. 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)

  16. 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

  17. 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.

  18. 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…

  19. 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.

  20. Quality assurance in Zambia.

    PubMed

    Reinke, J; Tembo, J; Limbambala, M F; Chikuta, S; Zaenger, D

    1996-01-01

    Primary health care reforms in Zambia have focused on the themes of effective leadership, community involvement, and improved service quality. To achieve these goals, the Ministry of Health's structure has been decentralized and a Health Reforms Implementation Team (including a Quality Assurance Unit) has been established. This unit collaborates with government and private sector organizations and professional groups in areas such as strategic planning, problem solving, facility assessment, standards setting, and indicator development. Each province has two linkage facilitators who provide district-level training and support to quality assurance coaches. As part of this process, staff at Nanga Rural Health Center in Mazabuka District selected patient privacy as a priority quality assurance issue and established an enclosed area for patient interviews. This measure facilitated increased patient disclosure about and comfort with discussing sensitive medical issues such as family planning and sexually transmitted diseases. Next, the health center staff examined the problem of pharmaceutical shortages, and user fees were identified as a means of purchasing commonly unavailable drugs. At the Magoye Rural Health Center, quality assurance assessment led to the consolidation of services such as infant weighing and immunization at the same location, thereby significantly increasing service utilization.

  1. 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.

  2. 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

  3. 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.

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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.

  10. 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

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

    PubMed

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

    2010-01-01

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

  12. 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.

  13. 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

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

    PubMed

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

    2000-01-01

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

  15. 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.

  16. 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.

  17. 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).

  18. 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

  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.

  20. Operating and Assurance Program Plan. Revision 4

    SciTech Connect

    Not Available

    1994-07-01

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

  1. 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.

  2. 16 CFR 1633.6 - Quality assurance requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Quality assurance requirements. 1633.6 Section 1633.6 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE FLAMMABILITY (OPEN FLAME) OF MATTRESS SETS The Standard § 1633.6 Quality...

  3. 16 CFR 1633.6 - Quality assurance requirements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Quality assurance requirements. 1633.6 Section 1633.6 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE FLAMMABILITY (OPEN FLAME) OF MATTRESS SETS The Standard § 1633.6 Quality...

  4. 16 CFR 1633.6 - Quality assurance requirements.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Quality assurance requirements. 1633.6 Section 1633.6 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE FLAMMABILITY (OPEN FLAME) OF MATTRESS SETS The Standard § 1633.6 Quality...

  5. 16 CFR 1633.6 - Quality assurance requirements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Quality assurance requirements. 1633.6 Section 1633.6 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE FLAMMABILITY (OPEN FLAME) OF MATTRESS SETS The Standard § 1633.6 Quality...

  6. 16 CFR 1633.6 - Quality assurance requirements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Quality assurance requirements. 1633.6 Section 1633.6 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE FLAMMABILITY (OPEN FLAME) OF MATTRESS SETS The Standard § 1633.6 Quality...

  7. 10 CFR 72.142 - Quality assurance organization.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Quality assurance organization. 72.142 Section 72.142 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF... considerations are opposed to safety considerations, are provided. Because of the many variables involved,...

  8. 10 CFR 72.142 - Quality assurance organization.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Quality assurance organization. 72.142 Section 72.142 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF... considerations are opposed to safety considerations, are provided. Because of the many variables involved,...

  9. 10 CFR 72.142 - Quality assurance organization.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Quality assurance organization. 72.142 Section 72.142 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF... considerations are opposed to safety considerations, are provided. Because of the many variables involved,...

  10. 10 CFR 72.142 - Quality assurance organization.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Quality assurance organization. 72.142 Section 72.142 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF... considerations are opposed to safety considerations, are provided. Because of the many variables involved,...

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  13. 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.

  14. Safety and efficacy of G-CSF mobilization and collection of autologous peripheral blood stem cells in children with cerebral palsy.

    PubMed

    Moon, Jin-Hwa; Kim, Mi Jung; Song, Soon-Young; Lee, Young-Jun; Choi, Yun Young; Kim, Seung Hyun; Lee, Young-Ho

    2013-12-01

    We hypothesized that mobilized peripheral blood stem cells (PBSCs) could be useful for treating neurological impairments and therefore assessed the safety of administering G-CSF followed by collecting PBSC in children with cerebral palsy (CP). G-CSF (10 μg/kg/day) was administered subcutaneously for 5 days, and apheresis was performed to collect PBSC via central venous catheter. G-CSF-related events occurred in 3 patients (fever in 2, irritability in 1). No catheter-related complications were reported. None of the patients needed platelet transfusion or calcium replacement during apheresis. Mobilization with G-CSF followed by PBSC collection appears to be safe and feasible in CP children.

  15. 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

  16. 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…

  17. Evaluation Research and Quality Assurance.

    ERIC Educational Resources Information Center

    Pesta, George; Respress, Trinetia; Major, Aline K.; Arazan, Christine; Coxe, Terry

    2002-01-01

    Describes the Juvenile Justice Educational Enhancement Program's implementation of an evaluation research-driven quality assurance process for Florida's juvenile justice educational programs. Reviews the literature on juvenile justice educational practices and describes the educational quality assurance standards and annual modifications that draw…

  18. Project Specific Quality Assurance Plan

    SciTech Connect

    Pedersen, K.S.

    1995-09-27

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

  19. 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

  20. 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

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

    PubMed Central

    2011-01-01

    Background A successful integration of the automated blood sampling (ABS) and telemetry (ABST) system is described. The new ABST system facilitates concomitant collection of physiological variables with blood and urine samples for determination of drug concentrations and other biochemical measures in the same rat without handling artifact. Method Integration was achieved by designing a 13 inch circular receiving antenna that operates as a plug-in replacement for the existing pair of DSI's orthogonal antennas which is compatible with the rotating cage and open floor design of the BASi Culex® ABS system. The circular receiving antenna's electrical configuration consists of a pair of electrically orthogonal half-toroids that reinforce reception of a dipole transmitter operating within the coil's interior while reducing both external noise pickup and interference from other adjacent dipole transmitters. Results For validation, measured baclofen concentration (ABST vs. satellite (μM): 69.6 ± 23.8 vs. 76.6 ± 19.5, p = NS) and mean arterial pressure (ABST vs. traditional DSI telemetry (mm Hg): 150 ± 5 vs.147 ± 4, p = NS) variables were quantitatively and qualitatively similar between rats housed in the ABST system and traditional home cage approaches. Conclusion The ABST system offers unique advantages over traditional between-group study paradigms that include improved data quality and significantly reduced animal use. The superior within-group model facilitates assessment of multiple physiological and biochemical responses to test compounds in the same animal. The ABST also provides opportunities to evaluate temporal relations between parameters and to investigate anomalous outlier events because drug concentrations, physiological and biochemical measures for each animal are available for comparisons. PMID:21244682

  2. 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.

  3. 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

  4. 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 ...

  5. 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.

  6. 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

  7. Radiation shielding quality assurance

    NASA Astrophysics Data System (ADS)

    Um, Dallsun

    For the radiation shielding quality assurance, the validity and reliability of the neutron transport code MCNP, which is now one of the most widely used radiation shielding analysis codes, were checked with lot of benchmark experiments. And also as a practical example, follows were performed in this thesis. One integral neutron transport experiment to measure the effect of neutron streaming in iron and void was performed with Dog-Legged Void Assembly in Knolls Atomic Power Laboratory in 1991. Neutron flux was measured six different places with the methane detectors and a BF-3 detector. The main purpose of the measurements was to provide benchmark against which various neutron transport calculation tools could be compared. Those data were used in verification of Monte Carlo Neutron & Photon Transport Code, MCNP, with the modeling for that. Experimental results and calculation results were compared in both ways, as the total integrated value of neutron fluxes along neutron energy range from 10 KeV to 2 MeV and as the neutron spectrum along with neutron energy range. Both results are well matched with the statistical error +/-20%. MCNP results were also compared with those of TORT, a three dimensional discrete ordinates code which was developed by Oak Ridge National Laboratory. MCNP results are superior to the TORT results at all detector places except one. This means that MCNP is proved as a very powerful tool for the analysis of neutron transport through iron & air and further it could be used as a powerful tool for the radiation shielding analysis. For one application of the analysis of variance (ANOVA) to neutron and gamma transport problems, uncertainties for the calculated values of critical K were evaluated as in the ANOVA on statistical data.

  8. 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...

  9. 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

  10. 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

  11. 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.

  12. Assuring quality of color graphics for aerospace interfaces

    NASA Astrophysics Data System (ADS)

    Arend, Lawrence E.

    2003-06-01

    Aerospace information displays require some form of quality assurance due to public safety concerns. However, the color design methodologies, standards, and guidelines employed in development of earlier displays are insufficient to guide current designs, which have reached map-like complexity. For these displays designers can only assure legibility and good attention management with designs that consider relations among all of the graphic elements. Quality assurance needs to focus on performance in context rather than graphic elements. We are investigating web-based color-guidance tools to help advance the design and review processes. Individual performance issues that guidance statements address are demonstrated in the context of a hyperlinked network of supporting infornation at varying levels of technical detail. Draft color designs can be developed and modified in this environment using web-based design tools that visualize the consequences of particular choices and the interactions among the chosen colors.

  13. 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.

  14. Feasibility and Safety of Intra-arterial Pericyte Progenitor Cell Delivery Following Mannitol-Induced Transient Blood-Brain Barrier Opening in a Canine Model.

    PubMed

    Youn, Sung Won; Jung, Keun-Hwa; Chu, Kon; Lee, Jong-Young; Lee, Soon-Tae; Bahn, Jae-jun; Park, Dong-Kyu; Yu, Jung-Suk; Kim, So-Yun; Kim, Manho; Lee, Sang Kun; Han, Moon-Hee; Roh, Jae-Kyu

    2015-01-01

    Stem cell therapy is currently being studied with a view to rescuing various neurological diseases. Such studies require not only the discovery of potent candidate cells but also the development of methods that allow optimal delivery of those candidates to the brain tissues. Given that the blood-brain barrier (BBB) precludes cells from entering the brain, the present study was designed to test whether hyperosmolar mannitol securely opens the BBB and enhances intra-arterial cell delivery. A noninjured normal canine model in which the BBB was presumed to be closed was used to evaluate the feasibility and safety of the tested protocol. Autologous adipose tissue-derived pericytes with platelet-derived growth factor receptor β positivity were utilized. Cells were administered 5 min after mannitol pretreatment using one of following techniques: (1) bolus injection of a concentrated suspension, (2) continuous infusion of a diluted suspension, or (3) bolus injection of a concentrated suspension that had been shaken by repeated syringe pumping. Animals administered a concentrated cell suspension without mannitol pretreatment served as a control group. Vital signs, blood parameters, neurologic status, and major artery patency were kept stable throughout the experiment and the 1-month posttreatment period. Although ischemic lesions were noted on magnetic resonance imaging in several mongrel dogs with concentrated cell suspension, the injection technique using repeated syringe shaking could avert this complication. The cells were detected in both ipsilateral and contralateral cortices and were more frequent at the ipsilateral and frontal locations, whereas very few cells were observed anywhere in the brain when mannitol was not preinjected. These data suggest that intra-arterial cell infusion with mannitol pretreatment is a feasible and safe therapeutic approach in stable brain diseases such as chronic stroke.

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

    NASA Astrophysics Data System (ADS)

    Feng, D.; Eyster, C.

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

  16. 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…

  17. 34 CFR 110.23 - Assurances required.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 1 2011-07-01 2011-07-01 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...

  18. 45 CFR 84.5 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false Assurances required. 84.5 Section 84.5 Public... 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 Director, that the program or activity will...

  19. 15 CFR 8b.5 - Assurances required.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 15 Commerce and Foreign Trade 1 2011-01-01 2011-01-01 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...

  20. 45 CFR 1170.51 - Assurances required.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 3 2011-10-01 2011-10-01 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...

  1. 29 CFR 32.5 - Assurances required.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 1 2011-07-01 2011-07-01 false 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...

  2. 38 CFR 18.405 - Assurances required.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2011-07-01 2011-07-01 false Assurances required. 18... 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...

  3. 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...

  4. 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...

  5. 34 CFR 104.5 - Assurances required.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 1 2011-07-01 2011-07-01 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,...

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

    PubMed

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

    2014-01-01

    In 1992, at the request of the French labor ministry following questions on the ability of medical biology laboratories to satisfactorily measure blood lead level (PbB), a national PbB quality control came into being. Only in 1996 did this external quality control include a number of laboratories sufficient to allow for a significant retrospective evaluation. After fifteen years (1996-2011), The French National Agency for Medicines and Health Products Safety wished to exploit the database collected. The number of participating laboratories went down from 73 to 41. On the other hand, the key finding pertained to the highly improved performance of the laboratories, which was associated with a spread decrease of the results over the entire range of tested PbBs (9 to 700 μg/L). Since 2006, we have observed increasing use of the inductively coupled plasma with mass spectrometry and decreasing use of electrothermal atomic absorption spectrometry. Provided that they rely on identical metrology expertise, the two analytical techniques lead to results on all the tested concentrations that are not statistically different. PMID:24492097

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

    PubMed

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

    2014-01-01

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

  8. 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.

  9. Quality assurance from a manufacturer's standpoint

    NASA Astrophysics Data System (ADS)

    Anderson, William J.

    1991-05-01

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

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

    USGS Publications Warehouse

    Dodge, Kent A.; Lambing, John H.

    2006-01-01

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

  11. 76 FR 33188 - Quality Assurance Requirements for Respirators; Notice of Withdrawal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-08

    ... Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention and the Mine Safety and... Withdrawal AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services... Services (HHS) is withdrawing its proposed rule to update the quality assurance and control...

  12. 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...

  13. 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 FY17 National Nonprofit Organization Funding Opportunity Application ...

  14. 76 FR 16758 - DOE Response to Recommendation 2010-1 of the Defense Nuclear Facilities Safety Board, Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-25

    ... our nuclear safety requirements to assure they were clear, concise, complete, and current. In March... progress in revising key nuclear safety Directives and the DOE Nuclear Safety Policy. We have not changed... have made significant nuclear safety improvements by upgrading facility safety bases and designs and...

  15. Online trust, trustworthiness, or assurance?

    PubMed

    Cheshire, Coye

    2011-01-01

    Every day, individuals around the world retrieve, share, and exchange information on the Internet. We interact online to share personal information, find answers to questions, make financial transactions, play social games, and maintain professional and personal relationships. Sometimes our online interactions take place between two or more humans. In other cases, we rely on computers to manage information on our behalf. In each scenario, risk and uncertainty are essential for determining possible actions and outcomes. This essay highlights common deficiencies in our understanding of key concepts such as trust, trustworthiness, cooperation, and assurance in online environments. Empirical evidence from experimental work in computer-mediated environments underscores the promises and perils of overreliance on security and assurance structures as replacements for interpersonal trust. These conceptual distinctions are critical because the future shape of the Internet will depend on whether we build assurance structures to limit and control ambiguity or allow trust to emerge in the presence of risk and uncertainty.

  16. 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.

  17. Online trust, trustworthiness, or assurance?

    PubMed

    Cheshire, Coye

    2011-01-01

    Every day, individuals around the world retrieve, share, and exchange information on the Internet. We interact online to share personal information, find answers to questions, make financial transactions, play social games, and maintain professional and personal relationships. Sometimes our online interactions take place between two or more humans. In other cases, we rely on computers to manage information on our behalf. In each scenario, risk and uncertainty are essential for determining possible actions and outcomes. This essay highlights common deficiencies in our understanding of key concepts such as trust, trustworthiness, cooperation, and assurance in online environments. Empirical evidence from experimental work in computer-mediated environments underscores the promises and perils of overreliance on security and assurance structures as replacements for interpersonal trust. These conceptual distinctions are critical because the future shape of the Internet will depend on whether we build assurance structures to limit and control ambiguity or allow trust to emerge in the presence of risk and uncertainty. PMID:22167913

  18. 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.

  19. 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.

  20. Oxygen safety

    MedlinePlus

    COPD - oxygen safety; Chronic obstructive pulmonary disease - oxygen safety; Chronic obstructive airways disease - oxygen safety; Emphysema - oxygen safety; Heart failure - oxygen-safety; Palliative care - oxygen safety; ...

  1. 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

  2. 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...

  3. 76 FR 25402 - Public Notice for Waiver of Aeronautical Land-Use Assurance; Richard Downing Airport, Coshocton, OH

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-04

    ... Federal Aviation Administration Public Notice for Waiver of Aeronautical Land-Use Assurance; Richard... land for release is vacant, not required for future development, safety, or compatible land use... the Federal Register 30 days before modifying the land-use assurance that requires the property to...

  4. 10 CFR Appendix B to Part 50 - Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... of 10 CFR 52.157 to include in its final safety analysis report a description of the quality... LICENSING OF PRODUCTION AND UTILIZATION FACILITIES Pt. 50, App. B Appendix B to Part 50—Quality Assurance... report a description of the quality assurance program to be applied to the design,...

  5. 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.

  6. Safety and maximum tolerated dose of superselective intraarterial cerebral infusion of bevacizumab after osmotic blood-brain barrier disruption for recurrent malignant glioma

    PubMed Central

    Boockvar, John A.; Tsiouris, Apostolos J.; Hofstetter, Christoph P.; Kovanlikaya, Ilham I; Fralin, Sherese; Kesavabhotla, Kartik; Seedial, Stephen M.; Pannullo, Susan C.; Schwartz, Theodore H.; Stieg, Philip; Zimmerman, Robert D.; Knopman, Jared; Scheff, Ronald J.; Christos, Paul; Vallabhajosula, Shankar; Riina, Howard A.

    2013-01-01

    Object The authors assessed the safety and maximum tolerated dose of superselective intraarterial cerebral infusion (SIACI) of bevacizumab after osmotic disruption of the blood-brain barrier (BBB) with mannitol in patients with recurrent malignant glioma. Methods A total of 30 patients with recurrent malignant glioma were included in the current study. Results The authors report no dose-limiting toxicity from a single dose of SIACI of bevacizumab up to 15 mg/kg after osmotic BBB disruption with mannitol. Two groups of patients were studied; those without prior bevacizumab exposure (naïve patients; Group I) and those who had received previous intravenous bevacizumab (exposed patients; Group II). Radiographic changes demonstrated on MR imaging were assessed at 1 month postprocedure. In Group I patients, MR imaging at 1 month showed a median reduction in the area of tumor enhancement of 34.7%, a median reduction in the volume of tumor enhancement of 46.9%, a median MR perfusion (MRP) reduction of 32.14%, and a T2-weighted/FLAIR signal decrease in 9 (47.4%) of 19 patients. In Group II patients, MR imaging at 1 month showed a median reduction in the area of tumor enhancement of 15.2%, a median volume reduction of 8.3%, a median MRP reduction of 25.5%, and a T2-weighted FLAIR decrease in 0 (0%) of 11 patients. Conclusions The authors conclude that SIACI of mannitol followed by bevacizumab (up to 15 mg/kg) for recurrent malignant glioma is safe and well tolerated. Magnetic resonance imaging shows that SIACI treatment with bevacizumab can lead to reduction in tumor area, volume, perfusion, and T2-weighted/FLAIR signal. PMID:20964595

  7. 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.

  8. 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…

  9. Assuring Quality in Education Evaluation.

    ERIC Educational Resources Information Center

    Trochim, William M. K.; Visco, Ronald J.

    1986-01-01

    A number of quality assurance educational evaluation methods are illustrated. Evaluation data obtained from the Providence, Rhode Island, school district are used. The methods are: (1) from auditing, internal control; (2) from accounting, double bookkeeping; and (3) from industrial quality control, acceptance sampling and cumulative percentage…

  10. 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.

  11. 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 ...

  12. 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 ...

  13. 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.

  14. 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

  15. 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.

  16. 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.

  17. The hospital transfusion committee: a step towards improved quality assurance.

    PubMed

    Calder, L; Woodfield, G

    1991-10-01

    Quality assurance has an important contribution to make in the judicious use of scarce resources. Auckland Hospital has established a transfusion committee because there was an escalating usage of blood and blood products which are expensive prescription medicines. A pilot audit of red cell transfusions indicated that 29% of red cell transfusions may have been unnecessary. A wide range of initiatives at Auckland Hospital has reduced blood product usage. Inappropriate use of blood carries an opportunity cost and may subject patients to unnecessary risk of reactions, including potential disease transmission. Strategies which need to be employed by transfusion committees include the introduction of clinical audit, physician education, restrictions on availability, and clinical budgeting. It is recommended that transfusion committees be set up in all major hospitals.

  18. 45 CFR 96.123 - Assurances.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 1 2013-10-01 2013-10-01 false Assurances. 96.123 Section 96.123 Public Welfare... Treatment Block Grant § 96.123 Assurances. (a) The application must include assurances that: (1) the State..., and other activities as prescribed by law and, also, for the purposes prescribed by law; (2)...

  19. 45 CFR 96.123 - Assurances.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 1 2014-10-01 2014-10-01 false Assurances. 96.123 Section 96.123 Public Welfare... Treatment Block Grant § 96.123 Assurances. (a) The application must include assurances that: (1) the State..., and other activities as prescribed by law and, also, for the purposes prescribed by law; (2)...

  20. 45 CFR 96.123 - Assurances.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 1 2011-10-01 2011-10-01 false Assurances. 96.123 Section 96.123 Public Welfare... Treatment Block Grant § 96.123 Assurances. (a) The application must include assurances that: (1) the State..., and other activities as prescribed by law and, also, for the purposes prescribed by law; (2)...

  1. 22 CFR 217.5 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Assurances required. 217.5 Section 217.5... PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE General Provisions § 217.5 Assurances required. (a) Assurances. An applicant for Federal financial assistance to which this part applies...

  2. 34 CFR 100.4 - Assurances required.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 1 2011-07-01 2011-07-01 false Assurances required. 100.4 Section 100.4 Education... TITLE VI OF THE CIVIL RIGHTS ACT OF 1964 § 100.4 Assurances required. (a) General. (1) Every application... pursuant to the application, contain or be accompanied by an assurance that the program will be...

  3. 32 CFR 195.6 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 2 2010-07-01 2010-07-01 false Assurances required. 195.6 Section 195.6... TITLE VI OF THE CIVIL RIGHTS ACT OF 1964 § 195.6 Assurances required. (a) General. (1)(i) Every... financial assistance pursuant to the application, contain or be accompanied by an assurance that the...

  4. 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...

  5. 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...

  6. 45 CFR 611.4 - Assurances required.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 3 2011-10-01 2011-10-01 false Assurances required. 611.4 Section 611.4 Public... CIVIL RIGHTS ACT OF 1964 § 611.4 Assurances required. (a) General. (1) Every application for Federal... assistance pursuant to the application, contain or be accompanied by an assurance that the program will...

  7. 22 CFR 209.5 - Assurance required.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Administrator of General Services (41 CFR 101-6.2). (b) Assurances from institutions. (1) In the case of any... 22 Foreign Relations 1 2011-04-01 2011-04-01 false Assurance required. 209.5 Section 209.5 Foreign... Assurance required. (a) General. (1) Every application for Federal financial assistance to which this...

  8. 22 CFR 142.5 - Assurances required.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 22 Foreign Relations 1 2011-04-01 2011-04-01 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...

  9. 45 CFR 80.4 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false Assurances required. 80.4 Section 80.4 Public... THE CIVIL RIGHTS ACT OF 1964 § 80.4 Assurances required. (a) General. (1) Every application for... the application, contain or be accompanied by an assurance that the program will be conducted or...

  10. 22 CFR 217.5 - Assurances required.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 22 Foreign Relations 1 2011-04-01 2011-04-01 false Assurances required. 217.5 Section 217.5... PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE General Provisions § 217.5 Assurances required. (a) Assurances. An applicant for Federal financial assistance to which this part applies...

  11. 29 CFR 31.6 - Assurances required.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 1 2011-07-01 2011-07-01 false 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...

  12. 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... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Assurance required. 209.5 Section 209.5 Foreign... Assurance required. (a) General. (1) Every application for Federal financial assistance to which this...

  13. 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...

  14. 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...

  15. 7 CFR 15.4 - Assurances required.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 1 2010-01-01 2010-01-01 false Assurances required. 15.4 Section 15.4 Agriculture... Assurances required. (a) General. (1) Every application for Federal financial assistance to which these... assurance that the applicant's program or activity will be conducted or the facility operated in...

  16. 45 CFR 1110.4 - Assurances required.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 3 2011-10-01 2011-10-01 false Assurances required. 1110.4 Section 1110.4 Public... HUMANITIES GENERAL NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS § 1110.4 Assurances required. (a) General... accompanied by an assurance that the program will be conducted or the facility operated in compliance with...

  17. 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…

  18. 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…

  19. 10 CFR 71.37 - Quality assurance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... quality assurance program that are applicable to the particular package design under consideration... Package Approval § 71.37 Quality assurance. (a) The applicant shall describe the quality assurance program (see Subpart H of this part) for the design, fabrication, assembly, testing, maintenance,...

  20. 10 CFR 71.37 - Quality assurance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... quality assurance program that are applicable to the particular package design under consideration... Package Approval § 71.37 Quality assurance. (a) The applicant shall describe the quality assurance program (see Subpart H of this part) for the design, fabrication, assembly, testing, maintenance,...

  1. 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...

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

    PubMed

    2015-05-27

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

  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. Quality assurance: the current challenge.

    PubMed

    Gruchy, C; Rogers, L G

    1990-04-01

    Occupational therapists are being challenged to measure and evaluate the care provided to their patients. This paper discusses the various stages of development of a quality assurance program within a large pediatric occupational therapy department. Several quality assurance activities undertaken are described, including the development of standards of clinical practice (based on the "Guidelines for the Client-Centred Practice of Occupational Therapy") and the development of assessment and documentation protocols. Outcome measurement in pediatric occupational therapy is addressed in relationship to the process measures which were developed in the department. The approaches to outcome measurement are outlined within the context of an audit attempting to evaluate the effectiveness of occupational therapy intervention based on five areas of evaluation.

  6. Information Assurance in Wireless Networks

    NASA Astrophysics Data System (ADS)

    Kabara, Joseph; Krishnamurthy, Prashant; Tipper, David

    2001-09-01

    Emerging wireless networks will contain a hybrid infrastructure based on fixed, mobile and ad hoc topologies and technologies. In such a dynamic architecture, we define information assurance as the provisions for both information security and information availability. The implications of this definition are that the wireless network architecture must (a) provide sufficient security measures, (b) be survivable under node or link attack or failure and (c) be designed such that sufficient capacity remains for all critical services (and preferably most other services) in the event of attack or component failure. We have begun a research project to investigate the provision of information assurance for wireless networks viz. survivability, security and availability and here discuss the issues and challenges therein.

  7. 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

  8. 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.

  9. 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

  10. 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.

  11. 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.

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

    PubMed

    Paushter, David M; Thomas, Stephen

    2016-03-01

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

  13. 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 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.

  15. [Food safety of GMOs].

    PubMed

    Joudrier, P

    2009-01-01

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

  16. National Patient Safety Foundation

    MedlinePlus

    ... Patient Safety Curriculum CPPS Review Course Patient Blood Management ... = null; var autoPlayDelaySeconds = 4; $navLeft.click(function() { currPanel--; $('#full-slider-nav-left').hide(); $('#full-slider- ...

  17. Research Opportunities to Improve Neonatal Red Blood Cell Transfusion.

    PubMed

    Patel, Ravi Mangal; Meyer, Erin K; Widness, John A

    2016-10-01

    Red blood cell (RBC) transfusion is a common and lifesaving therapy for anemic neonates and infants, particularly among those born prematurely or undergoing surgery. However, evidence-based indications for when to administer RBCs and adverse effects of RBC transfusion on important outcomes including necrotizing enterocolitis, survival, and long-term neurodevelopmental impairment remain uncertain. In addition, blood-banking practices for preterm and term neonates and infants have been largely developed using studies from older children and adults. Use of and refinements in emerging technologies and advances in biomarker discovery and neonatal-specific RBC transfusion databases may allow clinicians to better define and tailor RBC transfusion needs and practices to individual neonates. Decreasing the need for RBC transfusion and developing neonatal-specific approaches in the preparation of donor RBCs have potential for reducing resource utilization and cost, improving outcomes, and assuring blood safety. Finally, large donor-recipient-linked cohort studies can provide data to better understand the balance of the risks and benefits of RBC transfusion in neonates. These studies may also guide the translation of new research into best practices that can rapidly be integrated into routine care. This review highlights key opportunities in transfusion medicine and neonatology for improving the preparation and transfusion of RBCs into neonates and infants. We focus on timely, currently addressable knowledge gaps that can increase the safety and efficacy of preterm and term neonatal and infant RBC transfusion practices.

  18. Research Opportunities to Improve Neonatal Red Blood Cell Transfusion.

    PubMed

    Patel, Ravi Mangal; Meyer, Erin K; Widness, John A

    2016-10-01

    Red blood cell (RBC) transfusion is a common and lifesaving therapy for anemic neonates and infants, particularly among those born prematurely or undergoing surgery. However, evidence-based indications for when to administer RBCs and adverse effects of RBC transfusion on important outcomes including necrotizing enterocolitis, survival, and long-term neurodevelopmental impairment remain uncertain. In addition, blood-banking practices for preterm and term neonates and infants have been largely developed using studies from older children and adults. Use of and refinements in emerging technologies and advances in biomarker discovery and neonatal-specific RBC transfusion databases may allow clinicians to better define and tailor RBC transfusion needs and practices to individual neonates. Decreasing the need for RBC transfusion and developing neonatal-specific approaches in the preparation of donor RBCs have potential for reducing resource utilization and cost, improving outcomes, and assuring blood safety. Finally, large donor-recipient-linked cohort studies can provide data to better understand the balance of the risks and benefits of RBC transfusion in neonates. These studies may also guide the translation of new research into best practices that can rapidly be integrated into routine care. This review highlights key opportunities in transfusion medicine and neonatology for improving the preparation and transfusion of RBCs into neonates and infants. We focus on timely, currently addressable knowledge gaps that can increase the safety and efficacy of preterm and term neonatal and infant RBC transfusion practices. PMID:27424006

  19. European perspectives of food safety.

    PubMed

    Bánáti, Diána

    2014-08-01

    Food safety has been a growing concern among European Union (EU) citizens over the last decades. Despite the fact that food has never been safer, consumers are considerably uncertain and increasingly critical about the safety of their food. The introduction of new principles, such as the primary responsibility of producers, traceability, risk analysis, the separation of risk assessment and risk management provided a more transparent, science-based system in Europe, which can help to restore consumers' lost confidence. The present EU integrated approach to food safety 'from farm to fork' aims to assure a high level of food safety within the EU. PMID:24515443

  20. 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.

  1. 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.

  2. 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

  3. 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.

  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. 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...

  6. 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.

  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. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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.

  13. 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…

  14. 42 CFR 93.301 - Institutional assurances.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  15. 42 CFR 93.301 - Institutional assurances.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  16. 42 CFR 93.301 - Institutional assurances.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  17. 42 CFR 93.301 - Institutional assurances.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  18. 42 CFR 93.301 - Institutional assurances.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  19. Autonomous system for launch vehicle range safety

    NASA Astrophysics Data System (ADS)

    Ferrell, Bob; Haley, Sam

    2001-02-01

    The Autonomous Flight Safety System (AFSS) is a launch vehicle subsystem whose ultimate goal is an autonomous capability to assure range safety (people and valuable resources), flight personnel safety, flight assets safety (recovery of valuable vehicles and cargo), and global coverage with a dramatic simplification of range infrastructure. The AFSS is capable of determining current vehicle position and predicting the impact point with respect to flight restriction zones. Additionally, it is able to discern whether or not the launch vehicle is an immediate threat to public safety, and initiate the appropriate range safety response. These features provide for a dramatic cost reduction in range operations and improved reliability of mission success. .

  20. 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 ...

  1. Blood Disorders

    MedlinePlus

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

  2. 16 CFR 1101.33 - Reasonable steps to assure information release is fair in the circumstances.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... release in a particular situation and rather will issue a press release directed at certain localities... release is fair in the circumstances. 1101.33 Section 1101.33 Commercial Practices CONSUMER PRODUCT SAFETY... of the Acts It Administers § 1101.33 Reasonable steps to assure information release is fair in...

  3. 16 CFR 1101.33 - Reasonable steps to assure information release is fair in the circumstances.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... release in a particular situation and rather will issue a press release directed at certain localities... release is fair in the circumstances. 1101.33 Section 1101.33 Commercial Practices CONSUMER PRODUCT SAFETY... of the Acts It Administers § 1101.33 Reasonable steps to assure information release is fair in...

  4. 16 CFR 1101.33 - Reasonable steps to assure information release is fair in the circumstances.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... release in a particular situation and rather will issue a press release directed at certain localities... release is fair in the circumstances. 1101.33 Section 1101.33 Commercial Practices CONSUMER PRODUCT SAFETY... of the Acts It Administers § 1101.33 Reasonable steps to assure information release is fair in...

  5. 16 CFR 1101.33 - Reasonable steps to assure information release is fair in the circumstances.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... release in a particular situation and rather will issue a press release directed at certain localities... release is fair in the circumstances. 1101.33 Section 1101.33 Commercial Practices CONSUMER PRODUCT SAFETY... of the Acts It Administers § 1101.33 Reasonable steps to assure information release is fair in...

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

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... release in a particular situation and rather will issue a press release directed at certain localities... release is fair in the circumstances. 1101.33 Section 1101.33 Commercial Practices CONSUMER PRODUCT SAFETY... of the Acts It Administers § 1101.33 Reasonable steps to assure information release is fair in...

  7. 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…

  8. Nuclear Technology. Course 31: Quality Assurance Practices. Module 31-1, Overall Quality Assurance Program.

    ERIC Educational Resources Information Center

    Espy, John

    This first in a series of eight modules for a course titled Quality Assurance Practices describes responsibilities for quality assurance, identified how quality assurance requirements are passed on to other organizations, defines the three phases of activities of the plant, and reviews the eighteen criteria applicable to the quality assurance…

  9. Quality Assurance Reconsidered: A Case Study

    ERIC Educational Resources Information Center

    Gynnild, Vidar

    2007-01-01

    This article examines an external evaluation of the quality assurance system at the Norwegian University of Science and Technology (NTNU) conducted by The Norwegian Agency for Quality Assurance in Higher Education (NOKUT). The external audit report along with internal reports provided by the seven faculties of the university served as the major…

  10. Quality Assurance for Vendor/Processor Contracts.

    ERIC Educational Resources Information Center

    Advanced Technology, Inc., Reston, VA.

    The way that the U.S. Department of Education's Office of Student Financial Assistance (OSFA) should conduct its quality assurance function of monitoring a processing contractor is described. For the following quality assurance procedures, information is provided on the goal of the procedure, activities to be measured, measures, and the role of…

  11. 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: Interior Office of the Secretary of the Interior REQUIREMENTS FOR EQUAL OPPORTUNITY DURING CONSTRUCTION AND OPERATION OF THE ALASKA NATURAL GAS TRANSPORTATION SYSTEM § 34.5 Assurances. Every application for...

  12. 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...

  13. 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....

  14. 48 CFR 2453.246 - Quality Assurance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  15. 7 CFR 652.7 - Quality assurance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 6 2010-01-01 2010-01-01 false Quality assurance. 652.7 Section 652.7 Agriculture... AGRICULTURE SUPPORT ACTIVITIES TECHNICAL SERVICE PROVIDER ASSISTANCE General Provisions § 652.7 Quality assurance. (a) NRCS will review, in consultation with the Farm Service Agency, as appropriate, the...

  16. 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…

  17. 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... ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND OTHER NON-PROFIT ORGANIZATIONS Post-Award Requirements Reports and Records § 30.54 Quality assurance. If...

  18. Quality assurance manual: Volume 2, Appendices

    SciTech Connect

    Oijala, J.E.

    1988-06-01

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

  19. 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…

  20. 14 CFR 152.405 - Assurances.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Assurances. 152.405 Section 152.405 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRPORTS... grantee assures that it will undertake an affirmative action program, as required by 14 CFR part...

  1. Quality Assurance Program and Brain Drain

    ERIC Educational Resources Information Center

    Lien, Donald

    2008-01-01

    The number of colleges and universities in most developing countries has increased drastically over the past decades. The quality variation of these institutions is an alarming concern. Quality assurance programs are proposed and implemented. This paper evaluates the effects of quality assurance on the demand for college education, study abroad,…

  2. 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... HOMELAND SECURITY GENERAL NONDISCRIMINATION IN FEDERALLY-ASSISTED PROGRAMS (FEMA REG. 5) Nondiscrimination in FEMA-Assisted Programs-General § 7.7 Assurances required. Every application for Federal...

  3. 36 CFR 6.10 - Financial assurance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 1 2010-07-01 2010-07-01 false Financial assurance. 6.10... WASTE DISPOSAL SITES IN UNITS OF THE NATIONAL PARK SYSTEM § 6.10 Financial assurance. (a) The Regional Director will not require a bond or security deposit for a solid waste disposal site for which the...

  4. 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... HOMELAND SECURITY GENERAL NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE Introduction § 19.115 Assurance required. (a) General. Either at...

  5. 45 CFR 1203.5 - Assurances required.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 4 2011-10-01 2011-10-01 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,...

  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 Domestic Security DEPARTMENT OF HOMELAND SECURITY, OFFICE OF THE SECRETARY NONDISCRIMINATION ON THE BASIS....115 Assurance required. (a) General. Either at the application stage or the award stage,...

  7. 44 CFR 7.7 - Assurances required.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 44 Emergency Management and Assistance 1 2011-10-01 2011-10-01 false Assurances required. 7.7... HOMELAND SECURITY GENERAL NONDISCRIMINATION IN FEDERALLY-ASSISTED PROGRAMS (FEMA REG. 5) Nondiscrimination in FEMA-Assisted Programs-General § 7.7 Assurances required. Every application for Federal...

  8. 6 CFR 17.115 - Assurance required.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 6 Domestic Security 1 2011-01-01 2011-01-01 false Assurance required. 17.115 Section 17.115 Domestic Security DEPARTMENT OF HOMELAND SECURITY, OFFICE OF THE SECRETARY NONDISCRIMINATION ON THE BASIS....115 Assurance required. (a) General. Either at the application stage or the award stage,...

  9. 36 CFR 6.10 - Financial assurance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 36 Parks, Forests, and Public Property 1 2011-07-01 2011-07-01 false Financial assurance. 6.10... WASTE DISPOSAL SITES IN UNITS OF THE NATIONAL PARK SYSTEM § 6.10 Financial assurance. (a) The Regional Director will not require a bond or security deposit for a solid waste disposal site for which the...

  10. 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,...

  11. 44 CFR 19.115 - Assurance required.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 44 Emergency Management and Assistance 1 2011-10-01 2011-10-01 false Assurance required. 19.115... HOMELAND SECURITY GENERAL NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE Introduction § 19.115 Assurance required. (a) General. Either at...

  12. 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...

  13. 14 CFR 152.405 - Assurances.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 3 2012-01-01 2012-01-01 false Assurances. 152.405 Section 152.405 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRPORTS... grantee assures that it will undertake an affirmative action program, as required by 14 CFR part...

  14. 14 CFR 152.405 - Assurances.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 3 2013-01-01 2013-01-01 false Assurances. 152.405 Section 152.405 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRPORTS... grantee assures that it will undertake an affirmative action program, as required by 14 CFR part...

  15. 14 CFR 152.405 - Assurances.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Assurances. 152.405 Section 152.405 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRPORTS... grantee assures that it will undertake an affirmative action program, as required by 14 CFR part...

  16. 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.

  17. 50 CFR 81.9 - Assurances.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Fisheries UNITED STATES FISH AND WILDLIFE SERVICE, DEPARTMENT OF THE INTERIOR (CONTINUED) FINANCIAL ASSISTANCE-WILDLIFE SPORT FISH RESTORATION PROGRAM CONSERVATION OF ENDANGERED AND THREATENED SPECIES OF FISH, WILDLIFE, AND PLANTS-COOPERATION WITH THE STATES § 81.9 Assurances. The State must assure and certify...

  18. 50 CFR 81.9 - Assurances.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Fisheries UNITED STATES FISH AND WILDLIFE SERVICE, DEPARTMENT OF THE INTERIOR (CONTINUED) FINANCIAL ASSISTANCE-WILDLIFE SPORT FISH RESTORATION PROGRAM CONSERVATION OF ENDANGERED AND THREATENED SPECIES OF FISH, WILDLIFE, AND PLANTS-COOPERATION WITH THE STATES § 81.9 Assurances. The State must assure and certify...

  19. 50 CFR 81.9 - Assurances.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Fisheries UNITED STATES FISH AND WILDLIFE SERVICE, DEPARTMENT OF THE INTERIOR (CONTINUED) FINANCIAL ASSISTANCE-WILDLIFE SPORT FISH RESTORATION PROGRAM CONSERVATION OF ENDANGERED AND THREATENED SPECIES OF FISH, WILDLIFE, AND PLANTS-COOPERATION WITH THE STATES § 81.9 Assurances. The State must assure and certify...

  20. 14 CFR 1250.104 - Assurances.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Assurances. 1250.104 Section 1250.104 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION NONDISCRIMINATION IN FEDERALLY-ASSISTED PROGRAMS OF NASA-EFFECTUATION OF TITLE VI OF THE CIVIL RIGHTS ACT OF 1964 § 1250.104 Assurances....

  1. 14 CFR § 1250.104 - Assurances.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 5 2014-01-01 2014-01-01 false Assurances. § 1250.104 Section § 1250.104 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION NONDISCRIMINATION IN FEDERALLY-ASSISTED PROGRAMS OF NASA-EFFECTUATION OF TITLE VI OF THE CIVIL RIGHTS ACT OF 1964 § 1250.104 Assurances....

  2. 14 CFR 1250.104 - Assurances.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false Assurances. 1250.104 Section 1250.104 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION NONDISCRIMINATION IN FEDERALLY-ASSISTED PROGRAMS OF NASA-EFFECTUATION OF TITLE VI OF THE CIVIL RIGHTS ACT OF 1964 § 1250.104 Assurances....

  3. 50 CFR 600.240 - Security assurances.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 50 Wildlife and Fisheries 8 2010-10-01 2010-10-01 false Security assurances. 600.240 Section 600... ADMINISTRATION, DEPARTMENT OF COMMERCE MAGNUSON-STEVENS ACT PROVISIONS Council Membership § 600.240 Security assurances. Link to an amendment published at 75 FR 59153, Sept. 27, 2010. (a) DOC/OS will issue...

  4. 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.…

  5. Fault Management Architectures and the Challenges of Providing Software Assurance

    NASA Technical Reports Server (NTRS)

    Savarino, Shirley; Fitz, Rhonda; Fesq, Lorraine; Whitman, Gerek

    2015-01-01

    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.

  6. 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

  7. Training, Quality Assurance Factors, and Tools Investigation: a Work Report and Suggestions on Software Quality Assurance

    NASA Technical Reports Server (NTRS)

    Lee, Pen-Nan

    1991-01-01

    Previously, several research tasks have been conducted, some observations were obtained, and several possible suggestions have been contemplated involving software quality assurance engineering at NASA Johnson. These research tasks are briefly described. Also, a brief discussion is given on the role of software quality assurance in software engineering along with some observations and suggestions. A brief discussion on a training program for software quality assurance engineers is provided. A list of assurance factors as well as quality factors are also included. Finally, a process model which can be used for searching and collecting software quality assurance tools is presented.

  8. A quality assurance program for clinical pathology residents.

    PubMed

    Greenson, J K; Lee, S; Geller, S A

    1987-12-01

    A quality assurance study was undertaken to examine the clinical pathology residency program at Cedars-Sinai Medical Center. During a three-month period, clinical pathology residents kept a log of all the problems encountered while "on-call." A staff pathologist rated the performance of the resident in terms of how well he or she solved each problem. Of the 109 calls evaluated, one was judged to have been handled incorrectly, and 7 others were considered to have been answered in a conditional manner. The Blood Bank generated the largest number of calls (66), and requests for blood products were the single most common call (29). The review of all on-call problems with staff pathologists proved to be a valuable educational tool, both for the residents and staff. In addition, the study served as an impetus for development of a useful program for evaluating and, if necessary, correcting decisions made by pathology residents.

  9. ROC analysis in patient specific quality assurance

    SciTech Connect

    Carlone, Marco; MacPherson, Miller; Cruje, Charmainne; Rangel, Alejandra; McCabe, Ryan; Nielsen, Michelle

    2013-04-15

    Purpose: This work investigates the use of receiver operating characteristic (ROC) methods in patient specific IMRT quality assurance (QA) in order to determine unbiased methods to set threshold criteria for {gamma}-distance to agreement measurements. Methods: A group of 17 prostate plans was delivered as planned while a second group of 17 prostate plans was modified with the introduction of random multileaf collimator (MLC) position errors that are normally distributed with {sigma}{approx}{+-}0.5, {+-}1.0, {+-}2.0, and {+-}3.0 mm (a total of 68 modified plans were created). All plans were evaluated using five different {gamma}-criteria. ROC methodology was applied by quantifying the fraction of modified plans reported as 'fail' and unmodified plans reported as 'pass.'Results: {gamma}-based criteria were able to attain nearly 100% sensitivity/specificity in the detection of large random errors ({sigma} > 3 mm). Sensitivity and specificity decrease rapidly for all {gamma}-criteria as the size of error to be detected decreases below 2 mm. Predictive power is null with all criteria used in the detection of small MLC errors ({sigma} < 0.5 mm). Optimal threshold values were established by determining which criteria maximized sensitivity and specificity. For 3%/3 mm {gamma}-criteria, optimal threshold values range from 92% to 99%, whereas for 2%/2 mm, the range was from 77% to 94%. Conclusions: The optimal threshold values that were determined represent a maximized test sensitivity and specificity and are not subject to any user bias. When applied to the datasets that we studied, our results suggest the use of patient specific QA as a safety tool that can effectively prevent large errors (e.g., {sigma} > 3 mm) as opposed to a tool to improve the quality of IMRT delivery.

  10. NASA's Software Safety Standard

    NASA Technical Reports Server (NTRS)

    Ramsay, Christopher M.

    2005-01-01

    NASA (National Aeronautics and Space Administration) relies more and more on software to control, monitor, and verify its safety critical systems, facilities and operations. Since the 1960's there has hardly been a spacecraft (manned or unmanned) launched that did not have a computer on board that provided vital command and control services. Despite this growing dependence on software control and monitoring, there has been no consistent application of software safety practices and methodology to NASA's projects with safety critical software. Led by the NASA Headquarters Office of Safety and Mission Assurance, the NASA Software Safety Standard (STD-18l9.13B) has recently undergone a significant update in an attempt to provide that consistency. This paper will discuss the key features of the new NASA Software Safety Standard. It will start with a brief history of the use and development of software in safety critical applications at NASA. It will then give a brief overview of the NASA Software Working Group and the approach it took to revise the software engineering process across the Agency.

  11. They're Here! How to Prepare Your Blood Bank for Inspection.

    PubMed

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

    2015-01-01

    The importance of an inspection ready blood bank cannot be overemphasized. Various agencies perform inspections to ensure that facilities are compliant with federal and state regulations, as well as with standards defined by professional organizations. Inspections may strike fear into the staff members of the organizations being inspected. When a laboratory is in a state of constant readiness, such anxiety is likely to be lessened. Facilities may differ in structure and size and yet be held to the same standards. This article discusses the who, when, and why of laboratory safety inspections. We share helpful information gathered from various resources, including interviews with a quality assurance specialist, a blood bank manager, and an assessor, to help facilities work towards an inspection ready state. PMID:25673749

  12. They're Here! How to Prepare Your Blood Bank for Inspection.

    PubMed

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

    2015-01-01

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

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

    PubMed Central

    Shyamala, Venkatakrishna

    2014-01-01

    In the last few decades through an awareness of transfusion transmitted infections (TTI), a majority of countries have mandated serology based blood screening assays for Human immunodeficiency virus (HIV), Hepatitis C virus (HCV), and Hepatitis B virus (HBV). However, despite improved serology assays, the transfusion transmission of HIV, HCV, and HBV continues, primarily due to release of serology negative units that are infectious because of the window period (WP) and occult HBV infections (OBI). Effective mode of nucleic acid technology (NAT) testing of the viruses can be used to minimize the risk of TTIs. This review compiles the examples of NAT testing failures for all three viruses; analyzes the causes for failure, and the suggestions from retrospective studies to minimize such failures. The results suggest the safest path to be individual donation testing (ID) format for highest sensitivity, and detection of multiple regions for rapidly mutating and recombining viruses. The role of blood screening in the context of the donation and transfusion practices in India, the donor population, and the epidemiology is also discussed. World wide, as the public awareness of TTIs increases, as the recipient rights for safe blood are legally upheld, as the possibility to manage diseases such as hepatitis through expensive and prolonged treatment becomes accessible, and the societal responsibility to shoulder the health costs as in the case for HIV becomes routine, there is much to gain by preventing infections than treating diseases. PMID:24678167

  14. 75 FR 57956 - Draft Revision of the Federalwide Assurance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-23

    .../assurances_index.html. OHRP will consider comments received before implementing any revisions to the FWA...: www.hhs.gov/ohrp/assurances/assurances_index.html. The current FWA form has been approved by...

  15. 10 CFR 63.142 - Quality assurance criteria.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... portion of the quality assurance program at any location where activities subject to 10 CFR part 63 are... REPOSITORY AT YUCCA MOUNTAIN, NEVADA Quality Assurance § 63.142 Quality assurance criteria. (a)...

  16. 48 CFR 246.470 - Government contract quality assurance actions.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 3 2012-10-01 2012-10-01 false Government contract... ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT QUALITY ASSURANCE Government Contract Quality Assurance 246.470 Government contract quality assurance actions....

  17. 48 CFR 246.470 - Government contract quality assurance actions.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Government contract... ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT QUALITY ASSURANCE Government Contract Quality Assurance 246.470 Government contract quality assurance actions....

  18. 48 CFR 246.470 - Government contract quality assurance actions.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 3 2011-10-01 2011-10-01 false Government contract... ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT QUALITY ASSURANCE Government Contract Quality Assurance 246.470 Government contract quality assurance actions....

  19. 48 CFR 246.470 - Government contract quality assurance actions.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 3 2013-10-01 2013-10-01 false Government contract... ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT QUALITY ASSURANCE Government Contract Quality Assurance 246.470 Government contract quality assurance actions....

  20. 48 CFR 246.470 - Government contract quality assurance actions.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 3 2014-10-01 2014-10-01 false Government contract... ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT QUALITY ASSURANCE Government Contract Quality Assurance 246.470 Government contract quality assurance actions....

  1. Formal Foundations for Hierarchical Safety Cases

    NASA Technical Reports Server (NTRS)

    Denney, Ewen; Pai, Ganesh; Whiteside, Iain

    2015-01-01

    Safety cases are increasingly being required in many safety-critical domains to assure, using structured argumentation and evidence, that a system is acceptably safe. However, comprehensive system-wide safety arguments present appreciable challenges to develop, understand, evaluate, and manage, partly due to the volume of information that they aggregate, such as the results of hazard analysis, requirements analysis, testing, formal verification, and other engineering activities. Previously, we have proposed hierarchical safety cases, hicases, to aid the comprehension of safety case argument structures. In this paper, we build on a formal notion of safety case to formalise the use of hierarchy as a structuring technique, and show that hicases satisfy several desirable properties. Our aim is to provide a formal, theoretical foundation for safety cases. In particular, we believe that tools for high assurance systems should be granted similar assurance to the systems to which they are applied. To this end, we formally specify and prove the correctness of key operations for constructing and managing hicases, which gives the specification for implementing hicases in AdvoCATE, our toolset for safety case automation. We motivate and explain the theory with the help of a simple running example, extracted from a real safety case and developed using AdvoCATE.

  2. A Concept of Operations for an Integrated Vehicle Health Assurance System

    NASA Technical Reports Server (NTRS)

    Hunter, Gary W.; Ross, Richard W.; Berger, David E.; Lekki, John D.; Mah, Robert W.; Perey, Danie F.; Schuet, Stefan R.; Simon, Donald L.; Smith, Stephen W.

    2013-01-01

    This document describes a Concept of Operations (ConOps) for an Integrated Vehicle Health Assurance System (IVHAS). This ConOps is associated with the Maintain Vehicle Safety (MVS) between Major Inspections Technical Challenge in the Vehicle Systems Safety Technologies (VSST) Project within NASA s Aviation Safety Program. In particular, this document seeks to describe an integrated system concept for vehicle health assurance that integrates ground-based inspection and repair information with in-flight measurement data for airframe, propulsion, and avionics subsystems. The MVS Technical Challenge intends to maintain vehicle safety between major inspections by developing and demonstrating new integrated health management and failure prevention technologies to assure the integrity of vehicle systems between major inspection intervals and maintain vehicle state awareness during flight. The approach provided by this ConOps is intended to help optimize technology selection and development, as well as allow the initial integration and demonstration of these subsystem technologies over the 5 year span of the VSST program, and serve as a guideline for developing IVHAS technologies under the Aviation Safety Program within the next 5 to 15 years. A long-term vision of IVHAS is provided to describe a basic roadmap for more intelligent and autonomous vehicle systems.

  3. Update on compliance assurance monitoring

    SciTech Connect

    Freeman, L.E.

    1997-12-31

    In August, 1996, EPA released a revised draft of its proposal for a Compliance Assurance Monitoring (CAM) program. The proposal, which is intended to replace the Agency`s highly controversial 1993 proposal for {open_quotes}enhanced monitoring,{close_quotes} must be finalized by mid-1997 under court order. Many had hopes that EPA`s CAM proposal, by focussing on proper operation and maintenance of required control technologies rather than enforcement of numerical emission limitations, would provide a neutral resolution of issues associated with use of continuous compliance methods to enforce standards that were developed using limited, periodic data (and are currently enforceable with periodic stack tests). However, with this second draft of the CAM rule continuing to draw criticism from both industry (primarily for its effect on existing compliance obligations) and environmental groups (in part, for not requiring direct measurement of emissions), EPA appears to be a long way from reaching that goal. In the meantime, sources and states continue to work to meet deadlines for submission of applications and for issuance of Title V operating permits that must address issues currently being debated in the CAM rulemaking.

  4. Well casing grip assurance system

    SciTech Connect

    Mosing, D.E.; Webre, C.M.

    1987-06-30

    An apparatus is described for assuring that at least one of the elevator or the spider of well casing installation apparatus is fully closed in gripping connection about a well casing before the other of the elevator or the spider may be released from fully closed gripping connection about the well casing, the continuation comprising: (a) two-position elevator valve means connected to admit fluid pressure and to optionally direct it to open and close the elevator; (b) two-position spider valve means connected to admit fluid pressure into the spider and to optionally direct the fluid pressure to open and to close the spider; (c) two-position spider position valve means connected to the elevator valve means. The spider position valve means is mechanically connected for passing the fluid pressure to the elevator valve means only when the spider is fully closed into gripping position; and (d) two-position elevator position valve means connected to the spider valve means. The elevator position valve is mechanically connected to the elevator for passing fluid pressure to the spider valve when the elevator is fully closed into gripping position.

  5. Metrics for building performance assurance

    SciTech Connect

    Koles, G.; Hitchcock, R.; Sherman, M.

    1996-07-01

    This report documents part of the work performed in phase I of a Laboratory Directors Research and Development (LDRD) funded project entitled Building Performance Assurances (BPA). The focus of the BPA effort is to transform the way buildings are built and operated in order to improve building performance by facilitating or providing tools, infrastructure, and information. The efforts described herein focus on the development of metrics with which to evaluate building performance and for which information and optimization tools need to be developed. The classes of building performance metrics reviewed are (1) Building Services (2) First Costs, (3) Operating Costs, (4) Maintenance Costs, and (5) Energy and Environmental Factors. The first category defines the direct benefits associated with buildings; the next three are different kinds of costs associated with providing those benefits; the last category includes concerns that are broader than direct costs and benefits to the building owner and building occupants. The level of detail of the various issues reflect the current state of knowledge in those scientific areas and the ability of the to determine that state of knowledge, rather than directly reflecting the importance of these issues; it intentionally does not specifically focus on energy issues. The report describes work in progress and is intended as a resource and can be used to indicate the areas needing more investigation. Other reports on BPA activities are also available.

  6. Blood clotting

    MedlinePlus Videos and Cool Tools

    ... the external bleeding stops. Clotting factors in the blood cause strands of blood-borne material, called fibrin, to stick together and ... the inside of the wound. Eventually, the cut blood vessel heals, and the blood clot dissolves after ...

  7. FAA Airworthiness Assurance NDI Validation Center (AANC) operated by Sandia National Laboratories.

    SciTech Connect

    Roach, Dennis Patrick; Hartman, Roger D.

    2010-09-01

    Airworthiness Assurance NDI Validation Center (AANC) objectives are: (1) Enhance aircraft safety and reliability; (2) Aid developing advanced aircraft designs and maintenance techniques; (3) Provide our customers with comprehensive, independent, and quantitative/qualitative evaluations of new and enhanced inspection, maintenance, and repair techniques; (4) Facilitate transferring effective technologies into the aviation industry; (5) Support FAA rulemaking process by providing guidance on content & necessary tools to meet requirements or recommendations of FARs, ADs, ACs, SBs, SSIDs, CPCP, and WFD; and (6) Coordinate with and respond to Airworthiness Assurance Working Group (AAWG) in support of FAA Aviation Rulemaking Advisory Committee (ARAC).

  8. SWiFT Software Quality Assurance Plan.

    SciTech Connect

    Berg, Jonathan Charles

    2016-01-01

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

  9. SAPHIRE 8 Software Quality Assurance Oversight

    SciTech Connect

    Kurt G. Vedros

    2011-09-01

    The software quality assurance oversight consists of updating and maintaining revision control of the SAPHIRE 8 quality assurance program documentation and of monitoring revision control of the SAPHIRE 8 source code. This report summarizes the oversight efforts through description of the revision control system (RCS) setup, operation and contents. Documents maintained under revision control include the Acceptance Test Plan (ATP), Configuration Management Plan, Quality Assurance Plan, Software Project Plan, Requirements Traceability Matrix (RTM), System Test Plan, SDP Interface Training Manual, and the SAPHIRE 8, 'New Features and Capabilities Overview'.

  10. Assuring quality in high-consequence engineering

    SciTech Connect

    Hoover, Marcey L.; Kolb, Rachel R.

    2014-03-01

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

  11. Design reliability assurance program for Korean next generation reactor

    SciTech Connect

    Lee, Beom-Su; Han, Jin-Kyu; Na, Jang Hwan; Yoo, Kyung Yeong

    1997-12-01

    The Korean Next Generation Reactor (KNGR) project is to develop standardized nuclear power plant design for the construction of future nuclear power plants in Korea. The main purpose of the KNGR project is to develop the advanced nuclear power plants, which enhance safety and economics significantly through the incorporation of design concepts for severe accident prevention and mitigation, supplementary passive safety concept, simplification and application of modularization and so on. For those, Probabilistic Safety Assessment (PSA) and availability study will be performed at the early stage of the design, and the Design Reliability Assurance Program (D-RAP) is applied in the development of the KNGR to ensure that the safety and availability evaluated in the PSA and availability study at the early phase of the design is maintained through the detailed design, construction, procurement and operation of the plants. This paper presents the D-RAP concept that could be applied at the stage of the basic design of the nuclear power plants, based on the models for the reference plants and/or similar plants. 4 refs., 1 fig.

  12. Reliability assurance program and its relationship to other regulations

    SciTech Connect

    Polich, T.J.

    1994-12-31

    The need for a safety-oriented reliability effort for the nuclear industry was identified by the U.S. Nuclear Regulatory Commission (NRC) in the Three Mile Island Action Plan (NUREG-0660) Item II.C.4. In SECY-89-013, {open_quotes}Design Requirements Related to the Evolutionary ALWR,{close_quotes} the staff stated that the reliability assurance program (RAP) would be required for design certification to ensure that the design reliability of safety-significant structures, systems, and components (SSCs) is maintained over the life of a plant. In November 1988, the staff informed the advanced light water reactor (ALWR) vendors and the Electric Power Research Institute (EPRI) that it was considering this matter. Since that time, the staff has had numerous interactions with industry regarding RAP. These include discussions and subsequent safety evaluation reports on the EPRI utilities requirements document and for both Evolutionary Designs. The RAP has also been discussed in SECY-93-087, {open_quotes}Policy, Technical, and Licensing Issues Pertaining to Evolutionary and Advanced Light-Water Reactor (ALWR) Designs{close_quotes} and SECY-94-084, {open_quotes}Policy and Technical Issues Associated With the Regulatory Treatment of Non-Safety Systems in Passive Plant Designs.{close_quotes}

  13. 28 CFR 42.504 - Assurances required.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... financial assistance is extended or for another purpose involving the provisions of similar benefits, or for... shall contain a covenant running with the land assuring nondiscrimination on the condition described...

  14. 40 CFR 191.14 - Assurance requirements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  15. 50 CFR 80.21 - Assurances.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...) FINANCIAL ASSISTANCE-WILDLIFE SPORT FISH RESTORATION PROGRAM ADMINISTRATIVE REQUIREMENTS, PITTMAN-ROBERTSON WILDLIFE RESTORATION AND DINGELL-JOHNSON SPORT FISH RESTORATION ACTS § 80.21 Assurances. The State...

  16. 40 CFR 31.45 - Quality assurance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE AGREEMENTS TO STATE AND LOCAL GOVERNMENTS Post-Award Requirements Reports, Records, Retention, and Enforcement § 31.45 Quality assurance. If the grantee's...

  17. 40 CFR 31.45 - Quality assurance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE AGREEMENTS TO STATE AND LOCAL GOVERNMENTS Post-Award Requirements Reports, Records, Retention, and Enforcement § 31.45 Quality assurance. If the grantee's...

  18. Radiation Assurance for the Space Environment

    NASA Technical Reports Server (NTRS)

    Barth, Janet L.; LaBel, Kenneth A.; Poivey, Christian

    2004-01-01

    The space radiation environment can lead to extremely harsh operating conditions for spacecraft electronic systems. A hardness assurance methodology must be followed to assure that the space radiation environment does not compromise the functionality and performance of space-based systems during the mission lifetime. The methodology includes a definition of the radiation environment, assessment of the radiation sensitivity of parts, worst-case analysis of the impact of radiation effects, and part acceptance decisions which are likely to include mitigation measures.

  19. Quality assurance program for isotopic power systems

    SciTech Connect

    Hannigan, R.L.; Harnar, R.R.

    1982-12-01

    This report summarizes the Sandia National Laboratories Quality Assurance Program that applies to non-weapon (reimbursable) Radioisotopic Thermoelectric Generators. The program has been implemented over the past 16 years on power supplies used in various space and terrestrial systems. The quality assurance (QA) activity of the program is in support of the Department of Energy, Office of Space Nuclear Projects. Basic elements of the program are described in the report and examples of program decumentation are presented.

  20. Documentation of Hanford Site independent review of the Hanford Waste Vitrification Plant Preliminary Safety Analysis Report

    SciTech Connect

    Herborn, D.I.

    1991-10-01

    The requirements for Westinghouse Hanford independent review of the Preliminary Safety Analysis Report (PSAR) are contained in Section 1.0, Subsection 4.3 of WCH-CM-4-46. Specifically, this manual requires the following: (1) Formal functional reviews of the HWVP PSAR by the future operating organization (HWVP Operations), and the independent review organizations (HWVP and Environmental Safety Assurance, Environmental Assurance, and Quality Assurance); and (2) Review and approval of the HWVP PSAR by the Tank Waste Disposal (TWD) Subcouncil of the Safety and Environmental Advisory Council (SEAC), which provides independent advice to the Westinghouse Hanford President and executives on matters of safety and environmental protection. 7 refs.