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Sample records for assuring blood safety

  1. Safety Assurance in Obstetrical Ultrasound

    PubMed Central

    Miller, Douglas L

    2008-01-01

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

  2. Safety assurance in obstetrical ultrasound.

    PubMed

    Miller, Douglas L

    2008-04-01

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

  3. Safety Assurance for ATR Irradiations

    SciTech Connect

    S. Blaine Grover

    2006-10-01

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

  4. Globalisation and blood safety.

    PubMed

    Farrugia, Albert

    2009-05-01

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

  5. GSFC Safety and Mission Assurance Organization

    NASA Technical Reports Server (NTRS)

    Kelly, Michael P.

    2010-01-01

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

  6. Safety and Mission Assurance: A NASA Perspective

    NASA Technical Reports Server (NTRS)

    Higginbotham, Scott Alan

    2011-01-01

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

  7. Blood Gas Quality Assurance System

    PubMed Central

    Pickler, Lee

    1979-01-01

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

  8. Assuring NASA's Safety and Mission Critical Software

    NASA Technical Reports Server (NTRS)

    Deadrick, Wesley

    2015-01-01

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

  9. Software Safety Assurance of Programmable Logic

    NASA Technical Reports Server (NTRS)

    Berens, Kalynnda

    2002-01-01

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

  10. Safety and Mission Assurance Performance Metric

    NASA Technical Reports Server (NTRS)

    Holsomback, Jerry; Kuo, Fred; Wade, Jim

    2005-01-01

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

  11. Safety Assurance in NextGen

    NASA Technical Reports Server (NTRS)

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

    2012-01-01

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

  12. Dynamic Safety Cases for Through-Life Safety Assurance

    NASA Technical Reports Server (NTRS)

    Denney, Ewen; Pai, Ganesh; Habli, Ibrahim

    2015-01-01

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

  13. Software Quality Assurance for Nuclear Safety Systems

    SciTech Connect

    Sparkman, D R; Lagdon, R

    2004-05-16

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

  14. Safety and Mission Assurance Knowledge Management Retention

    NASA Technical Reports Server (NTRS)

    Johnson, Teresa A.

    2006-01-01

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

  15. Integrating Safety and Mission Assurance in Design

    NASA Technical Reports Server (NTRS)

    Cianciola, Chris; Crane, Kenneth

    2008-01-01

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

  16. Evaluation of reliability assurance approaches to operational nuclear safety

    SciTech Connect

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

    1984-01-01

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

  17. New safety assurance for biological skin covers.

    PubMed

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

    2002-01-01

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-04

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

  19. Office of Safety and Mission Assurance Review Report

    NASA Technical Reports Server (NTRS)

    2000-01-01

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

  20. Viral metagenomics and blood safety.

    PubMed

    Sauvage, V; Eloit, M

    2016-02-01

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

  1. Ensuring patient safety blood transfusision.

    PubMed

    Higgins, Dan; Jones, David

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

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

    NASA Technical Reports Server (NTRS)

    Malone, Roy W.; Safie, Fayssal M.

    2010-01-01

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

  3. Virginia Tech: The Challenge of Assuring Safety

    ERIC Educational Resources Information Center

    Rikleen, Lauren Stiller

    2007-01-01

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

  4. TOPAZ-2 Nuclear Power System safety assurance

    SciTech Connect

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

    1993-01-15

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

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

    SciTech Connect

    T. A. Tomberlin; S. B. Grover

    2004-11-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

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

    PubMed

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

    2004-01-01

    Organizations must continuously seek safety. When considering computerized health information systems, "safety" includes protecting the integrity, confidentiality, and availability of information assets such as patient information, key components of the technical information system, and critical personnel. "High Reliability Theory" (HRT) argues that organizations with strong leadership support, continuous training, redundant safety mechanisms, and "cultures of high reliability" can deploy and safely manage complex, risky technologies such as nuclear weapons systems or computerized health information systems. In preparation for the Health Insurance Portability and Accountability Act (HIPAA) of 1996, the Office of the Assistant Secretary of Defense (Health Affairs), the Offices of the Surgeons General of the United States Army, Navy and Air Force, and the Telemedicine and Advanced Technology Research Center (TATRC), US Army Medical Research and Materiel Command sponsored organizational, doctrinal, and technical projects that individually and collectively promote conditions for a "culture of information assurance." These efforts include sponsoring the "P3 Working Group" (P3WG), an interdisciplinary, tri-service taskforce that reviewed all relevant Department of Defense (DoD), Miliary Health System (MHS), Army, Navy and Air Force policies for compliance with the HIPAA medical privacy and data security regulations; supporting development, training, and deployment of OCTAVE(sm), a self-directed information security risk assessment process; and sponsoring development of the Risk Information Management Resource (RIMR), a Web-enabled enterprise portal about health information assurance. PMID:15650526

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

    PubMed

    Lachance, Paul A

    2004-04-15

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

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

    NASA Technical Reports Server (NTRS)

    Malone, Roy W., Jr.

    2010-01-01

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

  11. Safety of the Blood Supply in Latin America

    PubMed Central

    Schmunis, Gabriel A.; Cruz, Jose R.

    2005-01-01

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

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

    PubMed

    Ababouch, Lahsen

    2006-01-01

    International trade in fishery commodities reached US 58.2 billion dollars in 2002, a 5% improvement relative to 2000 and a 45% increase over 1992 levels. Within this global trade, developing countries registered a net trade surplus of US 17.4 billion dollars in 2002 and accounted for almost 50% by value and 55% of fish exports by volume. This globalization of fish trade, coupled with technological developments in food production, handling, processing and distribution, and the increasing awareness and demand of consumers for safe and high quality food have put food safety and quality assurance high in public awareness and a priority for many governments. Consequently, many countries have tightened food safety controls, imposing additional costs and requirements on imports. As early as 1980, there was an international drive towards adopting preventative HACCP-based safety and quality systems. More recently, there has been a growing awareness of the importance of an integrated, multidisciplinary approach to food safety and quality throughout the entire food chain. Implementation of this approach requires an enabling policy and regulatory environment at national and international levels with clearly defined rules and standards, establishment of appropriate food control systems and programmes at national and local levels, and provision of appropriate training and capacity building. This paper discusses the international framework for fish safety and quality, with particular emphasis on the United Nation's Food and Agricultural Organization's (FAO) strategy to promote international harmonization and capacity building. PMID:17052733

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

    SciTech Connect

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

    1982-01-01

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

  14. Work Done For the Safety and Assurance Directorate

    NASA Technical Reports Server (NTRS)

    Struhar, Paul T., Jr.

    2004-01-01

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

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

    NASA Technical Reports Server (NTRS)

    Beckman, Sean; Darpel, Scott

    2015-01-01

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

  16. Software quality assurance plans for safety-critical software

    SciTech Connect

    Liddle, P.

    2006-07-01

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

  17. Cascade Distillation System Design for Safety and Mission Assurance

    NASA Technical Reports Server (NTRS)

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

    2015-01-01

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

  18. Cascade Distillation System Design for Safety and Mission Assurance

    NASA Technical Reports Server (NTRS)

    Sargusingh, Miriam J.; Callahan, Michael R.

    2015-01-01

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

  19. Blood transfusion safety: a new philosophy.

    PubMed

    Franklin, I M

    2012-12-01

    Blood transfusion safety has had a chequered history, and there are current and future challenges. Internationally, there is no clear consensus for many aspects of the provision of safe blood, although pan-national legislation does provide a baseline framework in the European Union. Costs are rising, and new safety measures can appear expensive, especially when tested against some other medical interventions, such as cancer treatment and vaccination programmes. In this article, it is proposed that a comprehensive approach is taken to the issue of blood transfusion safety that considers all aspects of the process rather than considering only new measures. The need for an agreed level of safety for specified and unknown risks is also suggested. The importance of providing care and support for those inadvertently injured as a result of transfusion problems is also made. Given that the current blood safety decision process often uses a utilitarian principle for decision making--through the calculation of Quality Adjusted Life Years--an alternative philosophy is proposed. A social contract for blood safety, based on the principles of 'justice as fairness' developed by John Rawls, is recommended as a means of providing an agreed level of safety, containing costs and providing support for any adverse outcomes. PMID:23171300

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

    NASA Technical Reports Server (NTRS)

    Wetherholt, Martha

    2016-01-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

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

    NASA Astrophysics Data System (ADS)

    Gregory, Frederick D.

    1996-09-01

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

  3. [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

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

    PubMed

    Nakhleh, Raouf E

    2015-06-01

    Quality assurance encompasses monitoring daily processes for accurate, timely, and complete reports in surgical pathology. Quality assurance also includes implementation of policies and procedures that prevent or detect errors in a timely manner. This article presents uses of informatics in quality assurance. Three main foci are critical to the general improvement of diagnostic surgical pathology. First is the application of informatics to specimen identification with lean methods for real-time statistical control of specimen receipt and processing. Second is the development of case reviews before sign-out. Third is the development of information technology in communication of results to assure treatment in a timely manner. PMID:26065802

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

    PubMed

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

    2003-07-01

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

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

    PubMed

    Trouvin, Jean-Hugues

    2005-11-30

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

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

    NASA Technical Reports Server (NTRS)

    2002-01-01

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

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

    ERIC Educational Resources Information Center

    Craft, Nick

    2003-01-01

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

  9. Assure

    Integrated Risk Information System (IRIS)

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

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

    PubMed

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

    2015-02-01

    The level of safety attained in blood transfusion now makes this a discipline better managed care activities. This was achieved both by scientific advances and policy decisions regulating and supervising the activity, as well as by the quality system, which we recall that affects the entire organizational structure, responsibilities, procedures, processes and resources in place to achieve quality management. So, an effective quality system provides a framework within which activities are established, performed in a quality-focused way and continuously monitored to improve outcomes. This system quality has to irrigate all the actors of the transfusion, just as much the establishments of blood transfusion than the health establishments. PMID:25578550

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

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 2 2011-07-01 2011-07-01 false Safety and pollution prevention equipment... pollution prevention equipment quality assurance requirements. (a) General requirements. (1) Except as provided in paragraph (b)(1) of this section, you may install only certified safety and...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-05

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

  13. Management of National Nuclear Power Programs for assured safety

    SciTech Connect

    Connolly, T.J.

    1985-01-01

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

  14. Safety Assurances at Space Test Centres: Lessons Learned

    NASA Astrophysics Data System (ADS)

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

    2010-09-01

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

  15. 49 CFR Appendix C to Part 236 - Safety Assurance Criteria and Processes

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  16. 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.

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

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

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

    NASA Astrophysics Data System (ADS)

    Malone, Roy W.; Livingston, John M.

    2010-09-01

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

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

    ERIC Educational Resources Information Center

    Kimura, Aya Hirata

    2012-01-01

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

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

    SciTech Connect

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

    1987-09-01

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

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

    NASA Technical Reports Server (NTRS)

    Leitner, Jesse A.

    2014-01-01

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

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

    PubMed

    Smith, Alan D

    2011-01-01

    A general overview of various blood products operational effectiveness and related strategies that can be utilised by service providers (in particular, healthcare providers) is presented in the present study. In terms of the massive volumes of blood products, the North American blood centres collect more than eight million units of whole blood, which represents appropriately 50% of the US and Quebec, Canada?s volunteer donor blood supply. A case study of the quality inspection and inventory control concerns of the Central Blood Bank, located in the metropolitan area of Pittsburgh, PA, is presented. Initially, brief introduction to its general operating environment is followed by sections describing its general situation, quality-service initiatives, and followed by a fairly detailed discussion of the practical applications of lessons learned from the case study. PMID:22189177

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

    PubMed

    Stankovic, Ana K

    2004-12-01

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

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

    PubMed

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

    2016-08-01

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

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

    PubMed Central

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

    2012-01-01

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

  6. 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.

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

    SciTech Connect

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

    1989-10-31

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

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

    NASA Technical Reports Server (NTRS)

    Johnson, Teresa A.

    2006-01-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2015-12-01

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

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

    NASA Astrophysics Data System (ADS)

    Murray, Daniel P.; Weil, Andre

    2010-09-01

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

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

    PubMed

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

    2005-01-01

    The increasing number of physically challenged individuals has boosted the demand of powered wheelchairs. This paper is on the subject of a DSP (Digital Signal Processors) based assistive system, which is associated with a two-level checking scheme. The assistive system takes on the M3S (Multiple Master Multiple Slave) regulation for the assurance of safety. The CAN (Control Area Networks) embedded module in the DSP provides robust transmission of information within the system. The hardware interfaces based on the two-level checking scheme is implemented in input devices (e.g. joystick, head control apparatus) and in output devices (e.g. manipulator, prime mover motors). PMID:17281868

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

    NASA Technical Reports Server (NTRS)

    Kirkpatrick, Paul D.

    2014-01-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2015-03-01

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-30

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

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

    PubMed

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

    2014-02-01

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

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

    PubMed

    Hartwig, Valentina

    2015-06-01

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

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

    PubMed

    Ishikura, Satoshi

    2008-11-01

    The process of radiotherapy (RT) is complex and involves understanding of the principles of medical physics, radiobiology, radiation safety, dosimetry, radiation treatment planning, simulation and interaction of radiation with other treatment modalities. Each step in the integrated process of RT needs quality control and quality assurance (QA) to prevent errors and to give high confidence that patients will receive the prescribed treatment correctly. Recent advances in RT, including intensity-modulated and image-guided RT, focus on the need for a systematic RTQA program that balances patient safety and quality with available resources. It is necessary to develop more formal error mitigation and process analysis methods, such as failure mode and effect analysis, to focus available QA resources optimally on process components. External audit programs are also effective. The International Atomic Energy Agency has operated both an on-site and off-site postal dosimetry audit to improve practice and to assure the dose from RT equipment. Several countries have adopted a similar approach for national clinical auditing. In addition, clinical trial QA has a significant role in enhancing the quality of care. The Advanced Technology Consortium has pioneered the development of an infrastructure and QA method for advanced technology clinical trials, including credentialing and individual case review. These activities have an impact not only on the treatment received by patients enrolled in clinical trials, but also on the quality of treatment administered to all patients treated in each institution, and have been adopted globally; by the USA, Europe and Japan also. PMID:18952706

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

    PubMed

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

    2014-01-01

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

  19. 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.

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

    PubMed

    Gerber, Karen L; Freeman, Kathleen P

    2016-03-01

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

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

    SciTech Connect

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

    2004-12-01

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

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

    NASA Technical Reports Server (NTRS)

    1991-01-01

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

  3. The status of blood safety in ECO member states

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2010-10-01

    We conducted a radiological safety and quality assurance (QA) audit of 118 medical X-ray diagnostic machines installed in 45 major hospitals in India. The main objective of the audit was to verify compliance with the regulatory requirements stipulated by the national regulatory body. The audit mainly covered accuracy check of accelerating potential (kVp), linearity of tube current (mA station) and timer, congruence of radiation and optical field, and total filtration; in addition, we also reviewed medical X-ray diagnostic installations with reference to room layout of X-ray machines and conduct of radiological protection survey. A QA kit consisting of a kVp Test-O-Meter (ToM) (Model RAD/FLU-9001), dose Test-O-Meter (ToM) (Model 6001), ionization chamber-based radiation survey meter model Gun Monitor and other standard accessories were used for the required measurements. The important areas where there was noncompliance with the national safety code were: inaccuracy of kVp calibration (23%), lack of congruence of radiation and optical field (23%), nonlinearity of mA station (16%) and timer (9%), improper collimator/diaphragm (19.6%), faulty adjustor knob for alignment of field size (4%), nonavailability of warning light (red light) at the entrance of the X-ray room (29%), and use of mobile protective barriers without lead glass viewing window (14%). The present study on the radiological safety status of diagnostic X-ray installations may be a reasonably good representation of the situation in the country as a whole. The study contributes significantly to the improvement of radiological safety by the way of the steps already taken and by providing a vital feed back to the national regulatory body. PMID:21170188

  5. 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.

  6. 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.

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

    SciTech Connect

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

    1989-02-01

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

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

    NASA Astrophysics Data System (ADS)

    Iwaki, Y.

    2010-07-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    SciTech Connect

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

    2012-09-01

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

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

    SciTech Connect

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

    1995-06-01

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-08

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-22

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

  14. 78 FR 12062 - Nominations to the Advisory Committee on Blood and Tissue Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-21

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

  15. 76 FR 68192 - Meeting of the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-03

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

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

    PubMed

    Devine, Dana V; Schubert, Peter

    2016-06-01

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

  17. 30 CFR 250.806 - Safety and pollution prevention equipment quality assurance requirements.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  18. 30 CFR 250.806 - Safety and pollution prevention equipment quality assurance requirements.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  19. 30 CFR 250.806 - Safety and pollution prevention equipment quality assurance requirements.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

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

    PubMed Central

    Shiferaw, Yitayal

    2013-01-01

    Background. Transfusion associated bacterial infection has remained more frequent with a sever risk of morbidity and mortality. This study assessed the bacteriological safety of blood collected for transfusion. Method. A cross-sectional study was conducted at University of Gondar hospital blood bank from December 2011 to June 2012. Bacterial isolation, identification, and antimicrobial susceptibility tests were done as per the standard procedure. Chi-square test and P value were used to assess associations between risk factors and the bacterial isolation rate. Results. Twenty-one (15.33%) blood units were found contaminated with bacteria, and 95.24% contamination was due to external sources. The commonly isolated bacteria were Staphylococcus aureus, Coagulase negative Staphylococci, Escherichia coli, Klebsiella species, Streptococci species, Enterobacter species, and Citrobacter species. All of the bacteria isolated were 100% sensitive to Gentamicin, Chloramphenicol, Amoxicillin, and Doxycycline. Multiple antimicrobial resistances were observed in 66.7% of the isolates. Not using glove by phlebotomist, touching disinfected phlebotomy site and double puncture at the same hand or both hands of a donor were found to be risk factors for bacterial contamination. Conclusion. Bacterial contamination of blood to be transfused is a common problem in the hospital. So attention should be given to activities performed at the blood bank for safe transfusion practices. PMID:23864956

  1. 77 FR 67012 - Meeting of the Advisory Committee on Blood and Tissue Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-08

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

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

    PubMed

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

    2015-10-01

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

  3. 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…

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

    PubMed

    Cazenave, Jean-Pierre

    2010-12-01

    Transfusion of labile blood products (red cell concentrates, platelet concentrates and plasma) is vital in the absence of alternatives. Patients and doctors have always feared infections transmitted by blood, blood components and blood-derived drugs. It is potentially dangerous to delay implementation of pathogen inactivation in labile blood products pending a perfect process. Universal implementation of pathogen inactivation in labile blood products is a major step towards transfusion safety. PMID:22043595

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

    Bruny, Jennifer; Ziegler, Moritz

    2015-12-01

    Innovation is a crucial part of surgical history that has led to enhancements in the quality of surgical care. This comprises both changes which are incremental and those which are frankly disruptive in nature. There are situations where innovation is absolutely required in order to achieve quality improvement or process improvement. Alternatively, there are innovations that do not necessarily arise from some need, but simply are a new idea that might be better. All change must assure a significant commitment to patient safety and beneficence. Innovation would ideally enhance patient care quality and disease outcomes, as well stimulate and facilitate further innovation. The tensions between innovative advancement and patient safety, risk and reward, and demonstrated effectiveness versus speculative added value have created a contemporary "surgical conundrum" that must be resolved by a delicate balance assuring optimal patient/provider outcomes. This article will explore this delicate balance and the rules that govern it. Recommendations are made to facilitate surgical innovation through clinical research. In addition, we propose options that investigators and institutions may use to address competing priorities. PMID:26653169

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

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

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

    PubMed

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

    2016-06-01

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

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

    NASA Astrophysics Data System (ADS)

    Wessels, H.; Stephan, H. J.

    1991-08-01

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

  12. 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

  13. 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

  14. 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.

  15. Software Assurance Using Structured Assurance Case Models

    PubMed Central

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

    2010-01-01

    Software assurance is an important part of the software development process to reduce risks and ensure that the software is dependable and trustworthy. Software defects and weaknesses can often lead to software errors and failures and to exploitation by malicious users. Testing, certification and accreditation have been traditionally used in the software assurance process to attempt to improve software trustworthiness. In this paper, we examine a methodology known as a structured assurance model, which has been widely used for assuring system safety, for its potential application to software assurance. We describe the structured assurance model and examine its application and use for software assurance. We identify strengths and weaknesses of this approach and suggest areas for further investigation and testing. PMID:27134787

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

    PubMed

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

    2008-11-01

    Allergic Contact Dermatitis (ACD; chemical-induced skin sensitisation) represents a key consumer safety endpoint for the cosmetics industry. At present, animal tests (predominantly the mouse Local Lymph Node Assay) are used to generate skin sensitisation hazard data for use in consumer safety risk assessments. An animal testing ban on chemicals to be used in cosmetics will come into effect in the European Union (EU) from March 2009. This animal testing ban is also linked to an EU marketing ban on products containing any ingredients that have been subsequently tested in animals, from March 2009 or March 2013, depending on the toxicological endpoint of concern. Consequently, the testing of cosmetic ingredients in animals for their potential to induce skin sensitisation will be subject to an EU marketing ban, from March 2013 onwards. Our conceptual framework and strategy to deliver a non-animal approach to consumer safety risk assessment can be summarised as an evaluation of new technologies (e.g. 'omics', informatics), leading to the development of new non-animal (in silico and in vitro) predictive models for the generation and interpretation of new forms of hazard characterisation data, followed by the development of new risk assessment approaches to integrate these new forms of data and information in the context of human exposure. Following the principles of the conceptual framework, we have been investigating existing and developing new technologies, models and approaches, in order to explore the feasibility of delivering consumer safety risk assessment decisions in the absence of new animal data. We present here our progress in implementing this conceptual framework, with the skin sensitisation endpoint used as a case study. PMID:19025323

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

    SciTech Connect

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

    1985-01-01

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

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

    PubMed Central

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

    2012-01-01

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

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

    PubMed

    Mericka, P

    2006-01-01

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

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

    PubMed

    Khan, Ikhlas A; Smillie, Troy

    2012-09-28

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

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

    PubMed

    Berends, B R; van Knapen, F

    1999-10-01

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

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

    PubMed

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

    2015-09-10

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-06

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

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

    NASA Astrophysics Data System (ADS)

    Kauffmann, Paul J.

    1994-12-01

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

  5. 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.

  6. 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.

  7. Verification test problems for the calculation of probability of loss of assured safety in temperature-dependent systems with multiple weak and strong links.

    SciTech Connect

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

    2006-06-01

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

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

    NASA Technical Reports Server (NTRS)

    Ploutz-Snyder, Lori

    2009-01-01

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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

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

    1993-01-01

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

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

    NASA Astrophysics Data System (ADS)

    Cysewska-Sobusiak, Anna

    2001-08-01

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

  12. NASA assurance terms and definitions

    NASA Technical Reports Server (NTRS)

    1993-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2015-10-01

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

  15. 78 FR 28848 - Meeting of the Advisory Committee on Blood and Tissue Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-16

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

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

    PubMed Central

    Kent, Julie; Farrell, Anne-Maree

    2014-01-01

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

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

    PubMed

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

    2009-01-01

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

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

    NASA Technical Reports Server (NTRS)

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

    2009-01-01

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

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

    PubMed Central

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

    2010-01-01

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

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

    SciTech Connect

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

    2007-05-01

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

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

    PubMed Central

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

    2015-01-01

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

  2. Separation Assurance and Collision Avoidance

    NASA Technical Reports Server (NTRS)

    Lauderdale, Todd

    2010-01-01

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

  3. Producer quality assurance programs.

    PubMed

    Kla, J; Tollefson, L

    1999-03-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-01-01

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

  6. Blood

    MedlinePlus

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

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

    PubMed

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

    2014-03-01

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

  8. 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.

  9. Healthcare Software Assurance

    PubMed Central

    Cooper, Jason G.; Pauley, Keith A.

    2006-01-01

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

  10. Healthcare software assurance.

    PubMed

    Cooper, Jason G; Pauley, Keith A

    2006-01-01

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

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

    PubMed

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

    2015-12-01

    In recent years, several safety alerts have questioned or restricted the use of some pharmacological alternatives to allogeneic blood transfusion in established indications. In contrast, there seems to be a promotion of other alternatives, based on blood products and/or antifibrinolytic drugs, which lack a solid scientific basis. The Multidisciplinary Autotransfusion Study Group and the Anemia Working Group España convened a multidisciplinary panel of 23 experts belonging to different healthcare areas in a forum for debate to: 1) analyze the different safety alerts referred to certain transfusion alternatives; 2) study the background leading to such alternatives, the evidence supporting them, and their consequences for everyday clinical practice, and 3) issue a weighted statement on the safety of each questioned transfusion alternative, according to its clinical use. The members of the forum maintained telematics contact for the exchange of information and the distribution of tasks, and a joint meeting was held where the conclusions on each of the items examined were presented and discussed. A first version of the document was drafted, and subjected to 4 rounds of review and updating until consensus was reached (unanimously in most cases). We present the final version of the document, approved by all panel members, and hope it will be useful for our colleagues. PMID:26183121

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

    PubMed Central

    2015-01-01

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

  13. 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

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

    PubMed

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

    1990-05-01

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

  15. 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.

  16. Quality Assurance.

    ERIC Educational Resources Information Center

    Massachusetts Career Development Inst., Springfield.

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

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

    SciTech Connect

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

    1990-04-01

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

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

    SciTech Connect

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

    1988-02-01

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

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

    PubMed Central

    Cheung, Tommy Tsang; Cheung, Bernard Man Yung

    2014-01-01

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

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

    PubMed

    Lassale, B; Legrand, D; Chiaroni, J

    2010-02-01

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

  1. 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.

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

    PubMed

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

    2013-05-01

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

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

    PubMed

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

    2009-01-01

    As part of an overall design of a new, standardized RFID-enabled blood transfusion medicine supply chain, an assessment was conducted for two hospitals: the University of Iowa Hospital and Clinics (UIHC) and Mississippi Baptist Health System (MBHS). The main objectives of the study were to assess RFID technological and economic feasibility, along with possible impacts to productivity, quality and patient safety. A step-by-step process analysis focused on the factors contributing to process "pain points" (errors, inefficiency, product losses). A process re-engineering exercise produced blueprints of RFID-enabled processes to alleviate or eliminate those pain-points. In addition, an innovative model quantifying the potential reduction in adverse patient effects as a result of RFID implementation was created, allowing improvement initiatives to focus on process areas with the greatest potential impact to patient safety. The study concluded that it is feasible to implement RFID-enabled processes, with tangible improvements to productivity and safety expected. Based on a comprehensive cost/benefit model, it is estimated for a large hospital (UIHC) to recover investment from implementation within two to three years, while smaller hospitals may need longer to realize ROI. More importantly, the study estimated that RFID technology could reduce morbidity and mortality effects substantially among patients receiving transfusions. PMID:19894488

  4. 10 CFR 76.93 - Quality assurance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  5. 10 CFR 76.93 - Quality assurance.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Quality assurance. 76.93 Section 76.93 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.93 Quality assurance. The Corporation shall establish, maintain, and execute a quality assurance program satisfying each...

  6. 10 CFR 76.93 - Quality assurance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Quality assurance. 76.93 Section 76.93 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.93 Quality assurance. The Corporation shall establish, maintain, and execute a quality assurance program satisfying each...

  7. 10 CFR 76.93 - Quality assurance.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Quality assurance. 76.93 Section 76.93 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.93 Quality assurance. The Corporation shall establish, maintain, and execute a quality assurance program satisfying each...

  8. 10 CFR 76.93 - Quality assurance.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Quality assurance. 76.93 Section 76.93 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.93 Quality assurance. The Corporation shall establish, maintain, and execute a quality assurance program satisfying each...

  9. Blood

    MedlinePlus

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

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

    PubMed Central

    Heinrich, Michael

    2015-01-01

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

  11. Nova laser assurance-management system

    SciTech Connect

    Levy, A.J.

    1983-07-18

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

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

    PubMed

    Abdullah, Saleh; Karunamoorthi, Kaliyaperumal

    2016-01-01

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

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

    PubMed

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

    2006-07-01

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

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

    PubMed

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

    2014-06-01

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

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

    PubMed Central

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

    2014-01-01

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

  16. 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.

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2016-05-01

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

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

    PubMed

    Liras, Antonio

    2008-01-01

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

  20. Blood Frequently Asked Questions

    MedlinePlus

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

  1. 10 CFR 830.122 - Quality assurance criteria.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

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

  2. 10 CFR 830.122 - Quality assurance criteria.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

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

    PubMed

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

    2016-02-01

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

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

    PubMed Central

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

    2015-01-01

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

  5. 30 CFR 15.8 - Quality assurance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Quality assurance. 15.8 Section 15.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... § 15.8 Quality assurance. (a) Applicants granted an approval or an extension of approval under...

  6. 30 CFR 7.7 - Quality assurance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Quality assurance. 7.7 Section 7.7 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY General § 7.7 Quality assurance. Applicants...

  7. 30 CFR 15.8 - Quality assurance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  8. 30 CFR 14.8 - Quality assurance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  9. 30 CFR 7.7 - Quality assurance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  10. Healthy Family 2009: Assuring Healthy Aging

    MedlinePlus

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

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

    PubMed Central

    Gupta, Anshu; Gupta, Chhavi

    2016-01-01

    Context: Certain quality indicators are mandatory in the maintenance and improvement of quality in blood transfusion. Monitoring of such indicators should be done regularly and deficiencies are to be corrected for effective blood transfusion services. Aims: To study the usefulness of monitoring of the National Accreditation Board for Hospitals and Healthcare Providers (NABH) core indicators in blood transfusion and in the maintenance of hemovigilance. Settings and Design: Hemovigilance is a quality process to improve quality and increase the safety of blood transfusion. It covers and surveys all activities of the blood transfusion chain from donors to recipients. Core indicators’ monitoring is a part of the hemovigilance process. Materials and Methods: A 2-year retrospective study was conducted in a blood storage unit of a NABH accredited tertiary care hospital of a metropolitan city. Four NABH core indicators in blood transfusion were observed and monitored by the clinical and blood storage unit staff of different levels. Results: It was observed that there was an improvement in quality by core indicators monitoring with decreased wastage of blood and blood components, decreased average turnaround time for issue of blood and blood components, and lesser number of transfusion reactions. Conclusion: This study demonstrated that monitoring of NABH core indicators results in the enhancement of quality and safety in blood transfusion services, reducing the incidence of transfusion reactions. PMID:27011668

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2011-01-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

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

    2007-01-01

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

  16. Product assurance management and software product assurance

    NASA Technical Reports Server (NTRS)

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

    1991-01-01

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

  17. Quality assurance program plan for Building 324

    SciTech Connect

    Tanke, J.M.

    1997-05-22

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

  18. 75 FR 28619 - Meeting of the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-21

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

  19. 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…

  20. 78 FR 66006 - Meeting of the Advisory Committee on Blood and Tissue Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-04

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

  1. 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...

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

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Quality Assurance Program (QAP). 830.121 Section 830.121 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.121 Quality... the Quality Assurance criteria in § 830.122. (b) The contractor responsible for a DOE nuclear...

  3. 10 CFR 830.121 - Quality Assurance Program (QAP).

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  4. 10 CFR 830.122 - Quality assurance criteria.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  5. 10 CFR 830.122 - Quality assurance criteria.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

  6. 49 CFR 180.505 - Quality assurance program.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 3 2012-10-01 2012-10-01 false Quality assurance program. 180.505 Section 180.505 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY... Qualification and Maintenance of Tank Cars § 180.505 Quality assurance program. The quality assurance...

  7. 49 CFR 180.505 - Quality assurance program.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 3 2013-10-01 2013-10-01 false Quality assurance program. 180.505 Section 180.505 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY... Qualification and Maintenance of Tank Cars § 180.505 Quality assurance program. The quality assurance...

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

    PubMed

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

    2016-02-01

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

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

    PubMed

    Atreya, Chintamani D; Epstein, Jay S

    2007-01-01

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

  10. 23 CFR Appendix A to Part 1200 - Certification and Assurances for Highway Safety Grants (23 U.S.C. Chapter 4)

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  11. 23 CFR Appendix A to Part 1200 - CERTIFICATION AND ASSURANCES FOR HIGHWAY SAFETY GRANTS (23 U.S.C. CHAPTER 4)

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

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

    ClinicalTrials.gov

    2016-04-08

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

  13. Redefining and expanding quality assurance.

    PubMed

    Robins, J L

    1992-12-01

    To meet the current standards of excellence necessary for blood establishments, we have learned from industry that a movement toward organization-wide quality assurance/total quality management must be made. Everyone in the organization must accept responsibility for participating in providing the highest quality products and services. Quality must be built into processes and design systems to support these quality processes. Quality assurance has been redefined to include a quality planning function described as the most effective way of designing quality into processes. A formalized quality planning process must be part of quality assurance. Continuous quality improvement has been identified as the strategy every blood establishment must support while striving for error-free processing as the long-term objective. The auditing process has been realigned to support and facilitate this same objective. Implementing organization-wide quality assurance/total quality management is one proven plan for guaranteeing the quality of the 20 million products that are transfused into 4 million patients each year and for moving toward the new order. PMID:1286566

  14. Assured Crew Return Vehicle

    NASA Technical Reports Server (NTRS)

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

    1991-01-01

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

  15. 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

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

    PubMed

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

    2016-02-01

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

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

    PubMed

    Johnson, Andrew D; Cohn, Claudia S

    2016-10-01

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

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

    PubMed

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

    2012-10-01

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

  19. 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.

  20. [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

  1. 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)

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

    PubMed Central

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

    2012-01-01

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

  3. Rebuilding a safety culture

    NASA 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.

  4. Rebuilding a safety culture

    NASA Astrophysics Data System (ADS)

    Rodney, George A.

    1991-11-01

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

  5. QUALITY ASSURANCE UPDATE

    EPA Science Inventory

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

  6. Quality Assurance Project Plan

    SciTech Connect

    Holland, R. C.

    1998-06-01

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

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

    PubMed

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

    2015-04-01

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

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

    SciTech Connect

    Khericha, S.T.

    2002-06-30

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

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

    SciTech Connect

    Khericha, Soli T

    2002-06-01

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

  10. Multinational Quality Assurance

    ERIC Educational Resources Information Center

    Kinser, Kevin

    2011-01-01

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

  11. Reliability assurance for regulation of advanced reactors

    SciTech Connect

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

    1991-01-01

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

  12. Reliability assurance for regulation of advanced reactors

    SciTech Connect

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

    1991-12-31

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

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

    PubMed

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

    1996-02-01

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

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

    SciTech Connect

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

    1991-10-01

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

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

    SciTech Connect

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

    1991-10-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-04-01

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

  18. High assurance SPIRAL

    NASA Astrophysics Data System (ADS)

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

    2014-06-01

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

  19. Nuclear Powerplant Safety: Operations.

    ERIC Educational Resources Information Center

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

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

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

    PubMed

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

    2013-03-01

    Between July 2007 and December 2011, 2660 environmental drag swab samples were collected in total from California layer flocks on behalf of the California Egg Quality Assurance Program (CEQAP), the egg safety rule (21 CFR Parts 16 and 118) of the Food and Drug Administration (FDA), or both. The samples were processed by the California Animal Health and Food Safety Lab, and positive or negative results for Salmonella enterica serovar Enteritidis (SE) were recorded. This study retrospectively compares the differences between the FDA and CEQAP programs with respect to their SE environmental sampling surveillance results. To accomplish this comparison, two different CEQAP (new and old) data sets representing different SE environmental surveillance approaches in the life of the flock were compared against each other and against the FDA's SE environmental testing plan. Significant differences were noted between the CEQAP and FDA programs with respect to the prevalence of SE in the farm environment. Analyses of the prevalence of SE at different stages in the flock's life cycle (chick papers, preproduction, midproduction, postmolt, and premarket) found the highest prevalence of SE in premarket (11.9%), followed by postmolt (3.5%) and midproduction (3.4%), and there was a tie between chick papers and preproduction (2.1%). To assess the main effects of the presence of SE in the farm environment, backwards binary logistic regression was used. Of six independent variables examined (age of flock, year, season, owner, CEQAP membership, and analysis of pooled samples vs. individual swabs), only age of flock, owner, and year were determined to be significant factors in the final model. Although CEQAP membership and pooling vs. individuals swabs were not included in the final model, Pearson chi-square tests did show significantly higher odds of SE for non-CEQAP member farms and higher odds of SE in pooled samples vs. individual swabs. PMID:23678729

  1. 10 CFR 830.121 - Quality Assurance Program (QAP).

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-01-01

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

  3. 10 CFR 830.121 - Quality Assurance Program (QAP).

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Quality Assurance Program (QAP). 830.121 Section 830.121 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.121 Quality..., unless it is approved or rejected by DOE at an earlier date. (2) Modify the QAP as directed by DOE....

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

    PubMed

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

    2014-03-01

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

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

    PubMed Central

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

    2015-01-01

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

  6. Quality assurance for gamma knives

    SciTech Connect

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

    1995-09-01

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

  7. Towards Run-time Assurance of Advanced Propulsion Algorithms

    NASA Technical Reports Server (NTRS)

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

    2014-01-01

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

  8. Medical Device Safety

    MedlinePlus

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

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

    PubMed Central

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

    2013-01-01

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

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

    NASA Technical Reports Server (NTRS)

    Evans, John W.; DiVenti, Tony

    2016-01-01

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