Science.gov

Sample records for assuring blood safety

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

    PubMed

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

    2013-11-01

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

  2. 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

  3. 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.

  4. 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.

  5. Safety assurance of complex integrated systems

    NASA Technical Reports Server (NTRS)

    Abrignani, Vincent A.; Jordan, John R.

    1991-01-01

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

  6. Assuring NASA's Safety and Mission Critical Software

    NASA Technical Reports Server (NTRS)

    Deadrick, Wesley

    2015-01-01

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

  7. Software Safety Assurance of Programmable Logic

    NASA Technical Reports Server (NTRS)

    Berens, Kalynnda

    2002-01-01

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

  8. 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.

  9. Safety Assurance in NextGen

    NASA Technical Reports Server (NTRS)

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

    2012-01-01

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

  10. 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. Comprehensive Lifecycle for Assuring System Safety

    NASA Technical Reports Server (NTRS)

    Knight, John C.; Rowanhill, Jonathan C.

    2017-01-01

    CLASS is a novel approach to the enhancement of system safety in which the system safety case becomes the focus of safety engineering throughout the system lifecycle. CLASS also expands the role of the safety case across all phases of the system's lifetime, from concept formation to decommissioning. As CLASS has been developed, the concept has been generalized to a more comprehensive notion of assurance becoming the driving goal, where safety is an important special case. This report summarizes major aspects of CLASS and contains a bibliography of papers that provide additional details.

  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. 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

  14. 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

  15. 71 FR 76729 - New Entrant Safety Assurance Process

    Federal Register 2010, 2011, 2012, 2013, 2014

    2006-12-21

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

  16. 73 FR 76471 - New Entrant Safety Assurance Process

    Federal Register 2010, 2011, 2012, 2013, 2014

    2008-12-16

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

  17. 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.

  18. 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.

  19. 67 FR 31978 - New Entrant Safety Assurance Process

    Federal Register 2010, 2011, 2012, 2013, 2014

    2002-05-13

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

  20. 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.

  1. [Innovative technology and blood safety].

    PubMed

    Begue, S; Morel, P; Djoudi, R

    2016-11-01

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

  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. Safety assured financial evaluation of maintenance

    NASA Astrophysics Data System (ADS)

    Erguina, Vera

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

  5. 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.

  6. 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.

  7. Safety and Mission Assurance: A NASA Perspective

    NASA Technical Reports Server (NTRS)

    Higginbotham, Scott A.

    2016-01-01

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

  8. [Assuring food safety and nutritional quality].

    PubMed

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

    2014-01-01

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

  9. On the Provision of Safety Assurance via Safety Kernels for Modern Weapon Systems

    DTIC Science & Technology

    2006-03-22

    UNCLASSIFIED Defense Technical Information Center Compilation Part Notice ADP022173 TITLE: On the Provision of Safety Assurance via Safety Kernels...for Modern Weapon Systems DISTRIBUTION: Approved for public release, distribution unlimited This paper is part of the following report: TITLE...The component part is provided here to allow users access to individually authored sections f proceedings, annals, symposia, etc. However, the

  10. 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.

  11. 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.

  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.

  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. 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. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  15. 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.

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

    PubMed

    Westmoreland, Carl; Holmes, Anthony M

    2009-04-01

    Humans are exposed to a variety of chemicals in their everyday lives through interactions with the environment and through the use of consumer products. It is a basic requirement that these products are tested to assure they are safe under normal and reasonably foreseeable conditions of use. Within the European Union, the majority of tests used for generating toxicological data rely on animals. However recent changes in legislation (e.g., 7(th) amendment of the Cosmetics Directive and REACH) are driving researchers to develop and adopt non-animal alternative methods with which to assure human safety. Great strides have been made to this effect, but what other opportunities/technologies exist that could expedite this? Tissue engineering has increasing scope to contribute to replacing animals with scientifically robust alternatives in basic research and safety testing, but is this application of the technology being fully exploited? This review highlights how the consumer products industry is applying tissue engineering to ensure chemicals are safe for human use without using animals, and identifies areas for future development and application of the technology.

  17. 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.

  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. 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.

  20. SAFEGUARD: An Assured Safety Net Technology for UAS

    NASA Technical Reports Server (NTRS)

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

    2016-01-01

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

  1. Assuring safety without animal testing: Unilever's ongoing research programme to deliver novel ways to assure consumer safety.

    PubMed

    Westmoreland, Carl; Carmichael, Paul; Dent, Matt; Fentem, Julia; MacKay, Cameron; Maxwell, Gavin; Pease, Camilla; Reynolds, Fiona

    2010-01-01

    Assuring consumer safety without the generation of new animal data is currently a considerable challenge. However, through the application of new technologies and the further development of risk-based approaches for safety assessment, we remain confident it is ultimately achievable. For many complex, multi-organ consumer safety endpoints, the development, evaluation and application of new, non-animal approaches is hampered by a lack of biological understanding of the underlying mechanistic processes involved. The enormity of this scientific challenge should not be underestimated. To tackle this challenge a substantial research programme was initiated by Unilever in 2004 to critically evaluate the feasibility of a new conceptual approach based upon the following key components: 1.Developing new, exposure-driven risk assessment approaches. 2.Developing new biological (in vitro) and computer-based (in silico) predictive models. 3.Evaluating the applicability of new technologies for generating data (e.g. "omics", informatics) and for integrating new types of data (e.g. systems approaches) for risk-based safety assessment. Our research efforts are focussed in the priority areas of skin allergy, cancer and general toxicity (including inhaled toxicity). In all of these areas, a long-term investment is essential to increase the scientific understanding of the underlying biology and molecular mechanisms that we believe will ultimately form a sound basis for novel risk assessment approaches. Our research programme in these priority areas consists of in-house research as well as Unilever-sponsored academic research, involvement in EU-funded projects (e.g. Sens-it-iv, Carcinogenomics), participation in cross-industry collaborative research (e.g. Colipa, EPAA) and ongoing involvement with other scientific initiatives on non-animal approaches to risk assessment (e.g. UK NC3Rs, US "Human Toxicology Project" consortium).

  2. 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.

  3. 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. SPPE...

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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.

  10. 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…

  11. 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…

  12. 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 pollution...

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

    ERIC Educational Resources Information Center

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

    2004-01-01

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

  14. 74 FR 42833 - New Entrant Safety Assurance Process: Implementation of Section 210(b) of the Motor Carrier...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2009-08-25

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

  15. 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 the...

  16. Assuring rural hospital patient safety: what should be the priorities?

    PubMed

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

    2004-01-01

    Since reports on patient safety were issued by the Institute of Medicine, a number of interventions have been recommended and standards designed to improve hospital patient safety, including the Leapfrog, evidence-based safety standards. These standards are based on research conducted largely in urban hospitals, and it may not be possible to generalize them to rural hospitals. The absence of rural-relevant patient safety standards and interventions may diminish purchaser and public perceptions of rural hospitals, further undermining the financial stability of rural hospitals. This study sought to assess the current evidence concerning rural hospital patient safety and to identify a set of rural-relevant patient safety interventions that the majority of small rural hospitals could readily implement and that rural hospitals, purchasers, consumers, and others would find relevant and useful. These interventions should help rural hospitals prioritize patient safety efforts. As background, we reviewed literature; interviewed representatives of provider, payer, consumer, and governmental groups in 8 states; and calculated patient safety indicator rates in rural hospitals using the Agency for Healthcare Research and Quality's Health Care Cost and Utilization Project National Inpatient Sample. Based on the research literature and patient safety recommendations from national organizations, we developed a list of potentially important patient safety areas for rural hospitals. The rural relevance of these safety interventions was evaluated by a national expert panel in terms of the frequency of the problem, ability to implement, and the internal and external value to rural providers, purchasers, and consumers. The limited available research suggests that patient safety events and medical errors may be less likely to occur in rural than in urban hospitals. We identified 9 areas of patient safety and 26 priority patient safety interventions relevant to rural hospitals. Many of

  17. NASA Post-Columbia Safety & Mission Assurance, Review and Assessment Initiatives

    NASA Astrophysics Data System (ADS)

    Newman, J. Steven; Wander, Stephen M.; Vecellio, Don; Miller, Andrew J.

    2005-12-01

    On February 1, 2003, NASA again experienced a tragic accident as the Space Shuttle Columbia broke apart upon reentry, resulting in the loss of seven astronauts. Several of the findings and observations of the Columbia Accident Investigation Board addressed the need to strengthen the safety and mission assurance function at NASA. This paper highlights key steps undertaken by the NASA Office of Safety and Mission Assurance (OSMA) to establish a stronger and more- robust safety and mission assurance function for NASA programs, projects, facilities and operations. This paper provides an overview of the interlocking OSMA Review and Assessment Division (RAD) institutional and programmatic processes designed to 1) educate, inform, and prepare for audits, 2) verify requirements flow-down, 3) verify process capability, 4) verify compliance with requirements, 5) support risk management decision making, 6) facilitate secure web- based collaboration, and 7) foster continual improvement and the use of lessons learned.

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-04

    ... Motor Carrier Safety Administration (FMCSA) announces an operational test of procedural changes to the... for up to 12 months. It is applicable to new entrant motor carriers domiciled in the States of... entrant motor carriers that can demonstrate basic safety management controls by submitting compliance...

  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. © 2012 The Author. Transfusion Medicine © 2012 British Blood Transfusion Society.

  20. 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).

  1. Oxygen therapeutics: perfluorocarbons and blood substitute safety.

    PubMed

    Cohn, Claudia S; Cushing, Melissa M

    2009-04-01

    Current demands over the blood supply in developed and developing nations will compound over time. Red cell substitutes have a promising value proposition for transfusion services, because they hold the promise of increasing the availability of blood products and removing donor and contamination safety risks. In this article, the authors note that existing products suffer from critical shortcomings such as vasoactivity; they also point out that substitutes not based on human blood introduce potentially more complex safety hurdles. The authors discuss the attributes of an ideal blood substitute, and the mechanism and current status of perfluorocarbons; they also review the shortcomings of all oxygen therapeutic products in development today.

  2. 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.

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

    PubMed

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

    2004-02-01

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

  4. The role of microbiological testing in systems for assuring the safety of beef.

    PubMed

    Brown, M H; Gill, C O; Hollingsworth, J; Nickelson, R; Seward, S; Sheridan, J J; Stevenson, T; Sumner, J L; Theno, D M; Usborne, W R; Zink, D

    2000-12-05

    The use of microbiological testing in systems for assuring the safety of beef was considered at a meeting arranged by the International Livestock Educational Foundation as part of the International Livestock Congress, TX, USA, during February, 2000. The 11 invited participants from industry and government research organizations concurred in concluding that microbiological testing is necessary for the implementation and maintenance of effective Hazard Analysis Critical Control Point (HACCP) systems, which are the only means of assuring the microbiological safety of beef; that microbiological testing for HACCP purposes must involve the enumeration of indicator organisms rather than the detection of pathogens; that the efficacy of process control should be assessed against performance criteria and food safety objectives that refer to the numbers of indicator organisms in product; that sampling procedures should allow indicator organisms to be enumerated at very low numbers; and that food safety objectives and microbiological criteria are better related to variables, rather than attributes sampling plans.

  5. 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.

  6. 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…

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

    NASA Technical Reports Server (NTRS)

    Malone, Roy W.; Livingston, John M.

    2010-01-01

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

  8. 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…

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

    SciTech Connect

    Tanke, J.M.

    1997-05-22

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

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

    PubMed

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

    2015-12-01

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

  11. [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.

  12. Tainted blood: Probing safety practices in the Danish blood system.

    PubMed

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

    2015-09-01

    The existing literature on donor screening in transfusion medicine tends to distinguish between social concerns about discrimination and medical concerns about safety. In this article, we argue that the bifurcation into social and medical concerns is problematic. We build our case on a qualitative study of the historical rise and current workings of safety practices in the Danish blood system. Here, we identify a strong focus on contamination in order to avoid 'tainted blood', at the expense of working with risks that could be avoided through enhanced blood monitoring practices. Of further significance to this focus are the social dynamics found at the heart of safety practices aimed at avoiding contamination. We argue that such dynamics need more attention, in order to achieve good health outcomes in transfusion medicine. Thus, we conclude that, to ensure continuously safe blood systems, we need to move beyond the bifurcation of the social and medical aspects of blood supply as two separate issues and approach social dynamics as key medical safety questions. © The Author(s) 2014.

  13. Nanoscale sensors for assuring the safety of food products.

    PubMed

    Wang, Yun; Duncan, Timothy V

    2017-04-01

    As far as chemical analysis is concerned, foods are among the most difficult matrices to work with because they are complex, heterogeneous substances with a high degree of variety. Assaying foods for trace levels of chemical and microbiological substances is a challenge that often requires the application of time-consuming, expensive analytical instrumentation in dedicated facilities populated by highly trained personnel. Therefore there is a continued demand for new analytical technologies that can detect small concentrations of chemicals or microbes in a more cost- and time-effective manner, preferably in the field, on the production line, and/or non-destructively, with little to no sample pre-treatment, and possibly by individuals with scant scientific training. In the last decade, nanotechnology - a branch of science that takes advantage of the unique chemical and physical properties of matter on the nanoscale - has created new opportunities for both qualitative and quantitative detection of vapors/gasses, small molecules, biopolymers, and even living microbes in a fraction of the time and expense of traditional analytical techniques. This article offers a focused review of recent progress in nanotechnology-enabled biosensing as applied to foods and related matrices, paying particular attention to trends in the field, recent breakthroughs, and current areas of need. Special focus is paid to two primary categories of nanobiosensors - optical and electrochemical - and the discussion includes a comparison of their various strengths and weaknesses as they pertain ensuring the safety of the food supply.

  14. 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.

  15. 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.

  16. 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.

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

    NASA Technical Reports Server (NTRS)

    Johnson, Teresa A.

    2006-01-01

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

  18. 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.

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

    NASA Technical Reports Server (NTRS)

    Darpel, Scott; Beckman, Sean

    2016-01-01

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

  20. Certification Strategies using Run-Time Safety Assurance for Part 23 Autopilot Systems

    NASA Technical Reports Server (NTRS)

    Hook, Loyd R.; Clark, Matthew; Sizoo, David; Skoog, Mark A.; Brady, James

    2016-01-01

    Part 23 aircraft operation, and in particular general aviation, is relatively unsafe when compared to other common forms of vehicle travel. Currently, there exists technologies that could increase safety statistics for these aircraft; however, the high burden and cost of performing the requisite safety critical certification processes for these systems limits their proliferation. For this reason, many entities, including the Federal Aviation Administration, NASA, and the US Air Force, are considering new options for certification for technologies that will improve aircraft safety. Of particular interest, are low cost autopilot systems for general aviation aircraft, as these systems have the potential to positively and significantly affect safety statistics. This paper proposes new systems and techniques, leveraging run-time verification, for the assurance of general aviation autopilot systems, which would be used to supplement the current certification process and provide a viable path for near-term low-cost implementation. In addition, discussions on preliminary experimentation and building the assurance case for a system, based on these principles, is provided.

  1. 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.

  2. Patient blood management equals patient safety.

    PubMed

    Zacharowski, Kai; Spahn, Donat R

    2016-06-01

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

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

    PubMed

    Lindholm, A

    1988-01-01

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

  4. Evaluation of Design Assurance Regulations for Safety of Space Navigation Services

    NASA Astrophysics Data System (ADS)

    Ratti, B.; Sarno, M.; De Andreis, C.

    2005-12-01

    The European Space Agency (ESA), the European Community (EC), and the European Organisation for the Safety of Air Navigation (Eurocontrol) are contributing to the development of a Global positioning and Navigation Satellite System, known as GNSS. The development programme is carried out in two main steps:• GNSS-1: the first-generation system, based on signals received from the GPS (USA) and GLONASS (Russia) constellations, and augmentation systems like EGNOS (European Geostationary Navigation Overlay Service)• GNSS-2: the second-generation system, that will achieve the ultimate objective of European sovereignty for position determination, navigation and time dissemination. This system, named Galileo, comprises a global space and ground control infrastructure.The Galileo navigation signal will be used in the frame of safety-critical transport applications, thus it is necessary to assess the space safety assurance activity against the civil safety regulations and safety management system.. RTCA DO-254 and IEC 61508 standards, considered as part of best practice engineering references, for the development of safety- related systems in most applications, were selected during phases B2 and C0 of the Galileo project for this purpose.

  5. 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.

  6. 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).

  7. 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.

  8. Assurance Cases

    DTIC Science & Technology

    2015-01-26

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

  9. 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 and...

  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. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

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

    NASA Technical Reports Server (NTRS)

    Guarro, Sergio B.

    2010-01-01

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

  12. 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.

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

    NASA Astrophysics Data System (ADS)

    Hadley, John

    2005-09-01

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

  14. 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.

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

    PubMed Central

    Chukwuemeka, Iregbu Kenneth; Samuel, Yakubu

    2014-01-01

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

  16. 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.

  17. 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.

  18. 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.

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

    SciTech Connect

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

    1985-01-01

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

  20. Blood stem cell procurement: donor safety issues.

    PubMed

    Anderlini, P; Przepiorka, D; Körbling, M; Champlin, R

    1998-06-01

    Allogeneic transplantation of rhG-CSF-mobilized peripheral blood stem cells (PBSCs) is now being increasingly performed, but safety considerations for hematologically normal PBSC donors have not been fully addressed. Experience in this area is rapidly accumulating, however, and on the basis of currently available data, a consensus is gradually emerging on several issues: (1) rhG-CSF treatment and PBSC collection seem to have an acceptable short-term safety profile in normal donors. There is a need for continued safety monitoring, however. (2) rhG-CSF doses up to 10 microg/kg/day show a consistent dose-response relationship with the mobilization (and collection) of CD34+ progenitor cells, and this dose is acceptable for routine clinical use. Whether higher doses are superior (or cost-effective) remains to be determined, and they may produce more severe side-effects. The potential risks of marked leukocytosis (arbitrarily defined as a leukocyte count of more than 70 x 10(9)/l) have been a concern, and rhG-CSF dose reduction is performed by many centers to maintain leukocyte counts below this level. (3) Transient post-donation cytopenias, involving granulocytes, lymphocytes and platelets, may occur and are at least partly related to the leukapheresis procedure. These are generally asymptomatic and self-limited; follow-up blood counts are not necessarily required. Reinfusion of autologous platelet-rich plasma should be considered for donors with expected post-donation thrombocytopenia (platelet count <80-100 x 10(9)/l). (4) Donors should meet the eligibility criteria which apply to donors of apheresis platelets, with the exception that pediatric (as well as elderly) donors may also be considered. There is insufficient information at this time to clearly establish definite contraindications for PBSC collection in a hematologically normal donor. Potential contraindications include the presence of inflammatory, autoimmune or rheumatologic disorders, as well as

  1. 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.

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

    PubMed

    Py, J-Y

    2010-12-01

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

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

    NASA Technical Reports Server (NTRS)

    Withrow, Colleen A.; Reveley, Mary S.

    2015-01-01

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

  4. 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.

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

    PubMed Central

    Collins, Christopher M.

    2010-01-01

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

  6. Assuring safety of inherently unsafe medications: the FDA risk evaluation and mitigation strategies.

    PubMed

    Nelson, Lewis S; Loh, Meredith; Perrone, Jeanmarie

    2014-06-01

    The decision to approve a drug for clinical use is based on an understanding of its benefits versus the risks. Although efficacy is generally understood at the time of submission to the FDA for approval, the risks are more difficult to assess. Both PubMed (from 2000 to 2012) and the FDA website (www.fda.gov) were searched using the search terms "risk evaluation and mitigation strategy" (REMS). Articles for review were selected by relevance to topic, and their references were searched as well for additional relevant resources. Since the search results were not expected to contain research studies, formal quality assessment and inclusion and exclusion criteria were not utilized resulting in a narrative review. Few directly relevant research studies exist, although supporting documents such as government reports were available. For effective drugs with unclear or concerning safety records, the FDA has the option of requiring a risk evaluation and mitigation strategy, which allows a systematic approach to track and assure safe medication use. Over 100 different medications are currently covered by REMS, and each REMS is developed individually based on the needs of the specific drug or class. Although likely associated with improvements in medication safety, the potential benefit, limitations, and consequences of REMS are not yet fully understood.

  7. 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.

  8. 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)

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

    PubMed

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

    2013-08-01

    From 15 to 17 June 2011, a dedicated workshop was held on the subject of in vitro models for mammalian spermatogenesis and their applications in toxicological hazard and risk assessment. The workshop was sponsored by the Dutch ASAT initiative (Assuring Safety without Animal Testing), which aims at promoting innovative approaches toward toxicological hazard and risk assessment on the basis of human and in vitro data, and replacement of animal studies. Participants addressed the state of the art regarding human and animal evidence for compound mediated testicular toxicity, reviewed existing alternative assay models, and brainstormed about future approaches, specifically considering tissue engineering. The workshop recognized the specific complexity of testicular function exemplified by dedicated cell types with distinct functionalities, as well as different cell compartments in terms of microenvironment and extracellular matrix components. This complexity hampers quick results in the realm of alternative models. Nevertheless, progress has been achieved in recent years, and innovative approaches in tissue engineering may open new avenues for mimicking testicular function in vitro. Although feasible, significant investment is deemed essential to be able to bring new ideas into practice in the laboratory. For the advancement of in vitro testicular toxicity testing, one of the most sensitive end points in regulatory reproductive toxicity testing, such an investment is highly desirable. Copyright © 2013. Published by Elsevier Inc. All rights reserved.

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

    PubMed

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

    2005-04-15

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

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

    SciTech Connect

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

    2012-09-01

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

  12. 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.

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

    PubMed

    Emmanuel, Jean C

    2010-01-01

    Blood Transfusion Safety is dependent on effectively organised and managed blood services, which have adequate financial resources, skilled manpower, appropriate infrastructure and quality management systems in place. 80% of the world's population has access to 20% of the supply blood products, of which little is consistently safe. HIV highlighted the importance of blood safety. The lack of effective blood services in low human development index (LHDI), developing countries, has lead to international funding and capacity building for more than three decades. The initial strategies focused on providing HIV testing reagents to prevention transmission, however this only addresses one part of blood safety. Blood safety is not only dependent on preventing HIV transmission. In many populations there are other infectious agents, which have a higher prevalence. Ensuring the correct blood is provided to the patient depends on: well managed services with effective leadership and adequate budgets; capacity building and retention of skilled experienced staff; availability of laboratory equipment, correctly maintained; blood cold chain systems; procedures for tendering, purchasing and ensuring an unbroken supply of reagents and consumables; and quality management systems. Barriers for simplified effective tendering, procurement and contracting require urgent attention and coordination of all funding organisations to ensure an unbroken supply of reagents. Copyright 2009. Published by Elsevier Ltd.

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

    PubMed Central

    Aneke, John C.; Okocha, Chide E.

    2017-01-01

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

  15. Iron and blood donation- an under-recognised safety issue.

    PubMed

    Farrugia, A

    2007-01-01

    A growing body of evidence suggests that iron status is frequently affected by blood donation. Iron deficiency may be assessed through iron storage depletion measured by serum ferritin. These measurements indicate a high incidence of iron deficiency in repeat donors. This is not ameliorated through increasing pre-donation haemoglobin cut-offs. Depletion of tissue--rather then storage--iron, may be assessed by measurement of the serum transferrin receptor; such measurements in repeat donors indicate tissue iron depletion, but to a much lesser extent than storage iron depletion. A fuller understanding on how repeat donation affects donor health will allow better haematological criteria for donor selection to be developed. Blood agencies and standard-setting authorities need to accord the issue of donor iron and donation status as high a priority as that of any blood safety issue involving patient safety, if the safety and supply of the blood system is to be maintained.

  16. 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.

  17. Intrauterine abstinence syndrome (IAS) during buprenorphine inductions and methadone tapers: can we assure the safety of the fetus?

    PubMed

    McCarthy, John J

    2012-02-01

    An intrauterine abstinence syndrome (IAS) is a potentially fatal consequence of maternal opiate withdrawal. This study reviews the evidence for this syndrome. Withdrawal also creates an adverse environment for the developing fetal brain that can have long-term health effects. Effective methadone treatment eliminates risks of fetal withdrawal. However, concerns about neonatal abstinence syndrome (NAS) in methadone-exposed neonates have resulted in efforts to withdraw women from methadone during pregnancy or to use buprenorphine, a mixed agonist/antagonist opiate in place of methadone. Both approaches necessarily expose the fetus to either acute or chronic withdrawal. Routine fetal monitoring is not able to detect such symptoms, unless they are life-threatening. Therefore, the safety of the fetus during buprenorphine inductions or methadone tapers cannot be assured and the fetus should be protected from such procedures. Further research into methods of diagnosing IAS and its developmental consequences is needed to assure that attempts to reduce NAS do not harm the fetus.

  18. 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. © 2013 American Association of Blood Banks.

  19. 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 wells...

  20. 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 wells...

  1. 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 wells...

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

    ERIC Educational Resources Information Center

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

    2004-01-01

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

  3. 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. 49 CFR Appendix C to Part 236 - Safety Assurance Criteria and Processes

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ..., Part 17, 21, and 23. (vi) Safety of High-Speed Ground Transportation Systems. Analytical Methodology... RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RULES, STANDARDS, AND INSTRUCTIONS GOVERNING THE...: 2003, Railway Applications: Communications, Signaling, and Processing Systems-Safety Related Electronic...

  5. 49 CFR Appendix C to Part 236 - Safety Assurance Criteria and Processes

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ..., Part 17, 21, and 23. (vi) Safety of High-Speed Ground Transportation Systems. Analytical Methodology... RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RULES, STANDARDS, AND INSTRUCTIONS GOVERNING THE...: 2003, Railway Applications: Communications, Signaling, and Processing Systems-Safety Related Electronic...

  6. Safety cases for medical devices and health information technology: involving health-care organisations in the assurance of safety.

    PubMed

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

    2013-09-01

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

  7. 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.

  8. 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

  9. WHO's blood-safety initiative: a vain effort?

    PubMed

    Larkin, M

    2000-04-08

    On April 7, 2000, the WHO launched the new blood-safety campaign, which aims to increase the availability of safe blood in developing countries. The organization issued facts and figures on the state of the world's blood supply to spur governments to establish national transfusion systems. However, critics reported that the approach is unworkable in the very regions that it aims to protect. Jean Emmanuel, WHO director of blood safety and clinical technology, claimed that efficacy of transfusion services depends on national coordination and government support. On the other hand, Josef DeCosas, director of the Southern African AIDS Training Program in Zimbabwe, states that the success of organized blood-transfusion services in Zimbabwe depends on the network of roads and telephones and the availability of vehicles and fuel. In other African countries, these organized central blood-transfusion services take an enormous chunk of the health care budget. Furthermore, he stated that the central blood-bank scheme of the WHO would work for only a short while and would eventually fall since it does not complement the rest of the health care system, road system and electric supply.

  10. The potential of viral metagenomics in blood transfusion safety.

    PubMed

    Sauvage, V; Gomez, J; Boizeau, L; Laperche, S

    2017-09-01

    Thanks to the significant advent of high throughput sequencing in the last ten years, it is now possible via metagenomics to define the spectrum of the microbial sequences present in human blood samples. Therefore, metagenomics sequencing appears as a promising approach for the identification and global surveillance of new, emerging and/or unexpected viruses that could impair blood transfusion safety. However, despite considerable advantages compared to the traditional methods of pathogen identification, this non-targeted approach presents several drawbacks including a lack of sensitivity and sequence contaminant issues. With further improvements, especially to increase sensitivity, metagenomics sequencing should become in a near future an additional diagnostic tool in infectious disease field and especially in blood transfusion safety. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

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

    PubMed

    Slapak, Colleen; Fredrich, Nanci; Wagner, Jeffrey

    2011-12-01

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

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

    PubMed

    Slorach, S A

    2006-08-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  14. 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

    ... (6) identification of infectious disease transmission issues for blood, organs, blood stem cells and..., ethical and legal issues related to the safety of blood, blood products, and tissues; (4) the impact of...

  15. [Improving blood safety: errors management in transfusion medicine].

    PubMed

    Bujandrić, Nevenka; Grujić, Jasmina; Krga-Milanović, Mirjana

    2014-01-01

    The concept of blood safety includes the entire transfusion chain starting with the collection of blood from the blood donor, and ending with blood transfusion to the patient. The concept involves quality management system as the systematic monitoring of adverse reactions and incidents regarding the blood donor or patient. Monitoring of near-miss errors show the critical points in the working process and increase transfusion safety. The aim of the study was to present the analysis results of adverse and unexpected events in transfusion practice with a potential risk to the health of blood donors and patients. One-year retrospective study was based on the collection, analysis and interpretation of written reports on medical errors in the Blood Transfusion Institute of Vojvodina. Errors were distributed according to the type, frequency and part of the working process where they occurred. Possible causes and corrective actions were described for each error. The study showed that there were not errors with potential health consequences for the blood donor/patient. Errors with potentially damaging consequences for patients were detected throughout the entire transfusion chain. Most of the errors were identified in the preanalytical phase. The human factor was responsible for the largest number of errors. Error reporting system has an important role in the error management and the reduction of transfusion-related risk of adverse events and incidents. The ongoing analysis reveals the strengths and weaknesses of the entire process and indicates the necessary changes. Errors in transfusion medicine can be avoided in a large percentage and prevention is cost-effective, systematic and applicable.

  16. 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.

  17. Exposing exposure: enhancing patient safety through automated data mining of nuclear medicine reports for quality assurance and organ dose monitoring.

    PubMed

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

    2012-08-01

    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. 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. 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. 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.

  18. 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

  19. [Organize quality assurance as in aviation; improve patient safety in Dutch hospitals].

    PubMed

    Haerkens, Marck H T M; Beekmann, Roland T A; van den Elzen, Guus J P; Lansbergen, Michael D I; Berlijn, Dick L

    2009-01-01

    Failing teamwork is a major cause of adverse events in hospitals in the Netherlands. Training team-skills can improve the safety standards in clinical heath care. An adapted version of Crew Resource Management (CRM) training is proving to be a usable format in the hospital environment. We emphasize that paying attention to the subject of safety has to start early in medical education in order to incorporate non-technical skills into the hospital culture.

  20. Methods of analysis for toxic elements in food products. 3. Limit of determination of methods for assuring safety

    SciTech Connect

    Skurikhin, I.M.

    1989-03-01

    To evaluate the suitability of the analytical methods used in determining food safety, a new metrological characteristic ''MQS'' is suggested. MQS is defined as the absolute minimum quantity in micrograms of a substance that can be determined in a test solution (solubilized test portion). MQS accounts for 2 factors: (a) the necessity for a reliable determination of ML (maximum permitted level, i.e., regulatory tolerance), and (b) the optimum quantity of test portion of a food product to be analyzed, and thus assists in evaluating the suitability of a method to assure food safety. The MQS of 8 toxic elements in any food are As, 3; Cd, 0.5; Cu, 20; Fe, 50; Hg, 0.2; Pb, 4; Sn, 200; Zn, 100 micrograms. To characterize the applicability of any given method, the specific minimum limit of determination, MQSM, must be established for each method. The method in question may be used to control food safety only if MQSM is less than MQS. MQSM values are given for the common polarographic and colorimetric methods for determining these elements.

  1. 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.

  2. 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

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

    SciTech Connect

    Benedict, S.

    2015-06-15

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

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

    PubMed

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

    2007-12-01

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

  5. 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.

  6. 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. 2008 FRAME.

  7. 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

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

    PubMed

    Cockburn, Andrew

    2002-09-11

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

  9. Safety Assurance Factors for Electronic Health Record Resilience (SAFER): study protocol.

    PubMed

    Singh, Hardeep; Ash, Joan S; Sittig, Dean F

    2013-04-12

    Implementation and use of electronic health records (EHRs) could lead to potential improvements in quality of care. However, the use of EHRs also introduces unique and often unexpected patient safety risks. Proactive assessment of risks and vulnerabilities can help address potential EHR-related safety hazards before harm occurs; however, current risk assessment methods are underdeveloped. The overall objective of this project is to develop and validate proactive assessment tools to ensure that EHR-enabled clinical work systems are safe and effective. This work is conceptually grounded in an 8-dimension model of safe and effective health information technology use. Our first aim is to develop self-assessment guides that can be used by health care institutions to evaluate certain high-risk components of their EHR-enabled clinical work systems. We will solicit input from subject matter experts and relevant stakeholders to develop guides focused on 9 specific risk areas and will subsequently pilot test the guides with individuals representative of likely users. The second aim will be to examine the utility of the self-assessment guides by beta testing the guides at selected facilities and conducting on-site evaluations. Our multidisciplinary team will use a variety of methods to assess the content validity and perceived usefulness of the guides, including interviews, naturalistic observations, and document analysis. The anticipated output of this work will be a series of self-administered EHR safety assessment guides with clear, actionable, checklist-type items. Proactive assessment of patient safety risks increases the resiliency of health care organizations to unanticipated hazards of EHR use. The resulting products and lessons learned from the development of the assessment guides are expected to be helpful to organizations that are beginning the EHR selection and implementation process as well as those that have already implemented EHRs. Findings from our project

  10. The infectious disease blood safety risk of Australian hemochromatosis donations.

    PubMed

    Hoad, Veronica; Bentley, Peter; Bell, Barbara; Pathak, Praveen; Chan, Hiu Tat; Keller, Anthony

    2016-12-01

    It has been suggested that blood donors with hereditary hemochromatosis may pose an increased infectious disease risk and adversely affect recipient outcomes. This study compares the infectious disease risk of whole blood (WB) donors enrolled as therapeutic (T) donors to voluntary WB donors to evaluate the safety of blood products provided by the T donors. This was a retrospective cohort study of all WB donations at the Australian Red Cross Blood Service who donated between January 1, 2011, and December 31, 2013, comparing a yearly mean of 11,789 T donors with 107,773 total donations and a yearly mean of 468,889 voluntary WB donors with 2,584,705 total donations. We compared postdonation notification of infectious illnesses, bacterial contamination screening results, and positive tests for blood borne viruses in T and WB donors. Rates of transfusion-transmissible infections in donations destined for component manufacture were significantly lower in therapeutic donations compared to voluntary donations (8.4 vs. 21.6 per 100,000 donations). Bacterial contamination (43.0 vs. 45.9 per 100,000 donations) and postdonation illness reporting (136.2 vs. 110.8 per 100,000 donations) were similar in both cohorts. The Australian therapeutic venisection program enables T donors to provide a safe and acceptable source of donated WB that has a low infectious disease risk profile. © 2016 AABB.

  11. 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

  12. Mucocutaneous blood contact: blood release behavior of safety peripheral intravenous catheters.

    PubMed

    Wittmann, Andreas; Köver, Jan; Kralj, Nenad; Gasthaus, Klaus; Tosch, Marco; Hofmann, Friedrich

    2013-12-01

    Protection against needlestick injuries has significantly improved in recent years thanks to so-called "safety devices." However, a potential drawback occasionally reported by users is a risk of blood splashing. If this blood comes in contact with the mucous membranes, it could lead to an infection. Five safety peripheral intravenous catheter brands were examined in a laboratory test. To simulate the extreme situations, which may arise through human use, the introducer needle was withdrawn from the catheter at 2 different angles whereby an industrial robot was used to simulate the sequence of this movement. Each brand was tested 30 times. The experiment was carried out using radioactively labeled human whole blood. The measurements for the transmitted volume of blood was taken both from an artificial head and from a surface measuring 18.5 cm by 26.5 cm at a height of 30 cm above the catheter; scintigraphy was used to take the measurements. The volume of blood droplets potentially splashing into the mucous membranes was in the range of 1 nL. For normal virus concentrations in the blood of sick patients, this dose is too small to cause hepatitis C and HIV. Copyright © 2013 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

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

    PubMed

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

    2007-04-11

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

  14. 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

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

    PubMed

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

    2017-01-01

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

  16. 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. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. Safety assurance of non-deterministic flight controllers in aircraft applications

    NASA Astrophysics Data System (ADS)

    Noriega, Alfonso

    Loss of control is a serious problem in aviation that primarily affects General Aviation. Technological advancements can help mitigate the problem, but the FAA certification process makes certain solutions economically unfeasible. This investigation presents the design of a generic adaptive autopilot that could potentially lead to a single certification for use in several makes and models of aircraft. The autopilot consists of a conventional controller connected in series with a robust direct adaptive model reference controller. In this architecture, the conventional controller is tuned once to provide outer-loop guidance and navigation to a reference model. The adaptive controller makes unknown aircraft behave like the reference model, allowing the conventional controller to successfully provide navigation without the need for retuning. A strong theoretical foundation is presented as an argument for the safety and stability of the controller. The stability proof of direct adaptive controllers require that the plant being controlled has no unstable transmission zeros and has a nonzero high frequency gain. Because most conventional aircraft do not readily meet these requirements, a process known as sensor blending was used. Sensor blending consists of using a linear combination of the plant's outputs that has no unstable transmission zeros and has a nonzero high frequency gain to drive the adaptive controller. Although this method does not present a problem for regulators, it can lead to a steady state error in tracking applications. The sensor blending theory was expanded to take advantage of the system's dynamics to allow for zero steady state error tracking. This method does not need knowledge of the specific system's dynamics, but instead uses the structure of the A and B matrices to perform the blending for the general case. The generic adaptive autopilot was tested in two high-fidelity nonlinear simulators of two typical General Aviation aircraft. The results

  18. 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

  19. 76 FR 68192 - Meeting of the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-03

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

  20. 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.

  1. 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.

  2. 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.

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

    PubMed

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

    2004-06-01

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

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

    PubMed

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

    2013-01-01

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

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

    PubMed

    Cazenave, Jean-Pierre

    2010-12-01

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

  6. Whole blood pathogen reduction technology and blood safety in sub-Saharan Africa: A systematic review with regional discussion.

    PubMed

    Nkohkwo, Asa'ah; Agbor, Gabriel; Asongalem, Emmanuel; Tagny, Claude; Asonganyi, Tazoacha

    2016-01-01

    Despite vast improvements in transfusion services in sub-Saharan Africa over the last decade, there remain serious concerns on the safety and adequacy of the blood supply across the region. This review paper ascertains the role of pathogen reduction technology (PRT) in improving blood safety and supply adequacy in the region. The state of blood safety in sub-Saharan Africa was reviewed. Meetings, seminars and correspondence were undertaken with key clinicians, scientists and professional bodies in the region, including the World Health Organization's Regional Office for Africa, to examine the suitability of PRT for improving the safety of whole blood transfusion, a prevalent transfusion format in the region. Existing literature suggests that combining PRT with current blood safety measures (such as serology) would improve the safety and adequacy of the blood supply for transfusions in sub-Saharan Africa. This was echoed by the findings of the stakeholder meetings. Following a detailed appraisal of two leading PRT systems, the Mirasol(®) PRT System and the Cerus S-303 System, we suggest that companies conduct comprehensive toxicological evaluation of the agents used for PRT and publish this in the scientific literature. We also recommend that the safety and efficacy of these technologies should be established in a randomised clinical trial conducted in sub-Saharan Africa.

  7. Whole blood pathogen reduction technology and blood safety in sub-Saharan Africa: A systematic review with regional discussion

    PubMed Central

    Agbor, Gabriel; Asongalem, Emmanuel; Tagny, Claude; Asonganyi, Tazoacha

    2016-01-01

    Background Despite vast improvements in transfusion services in sub-Saharan Africa over the last decade, there remain serious concerns on the safety and adequacy of the blood supply across the region. Objective This review paper ascertains the role of pathogen reduction technology (PRT) in improving blood safety and supply adequacy in the region. Method The state of blood safety in sub-Saharan Africa was reviewed. Meetings, seminars and correspondence were undertaken with key clinicians, scientists and professional bodies in the region, including the World Health Organization’s Regional Office for Africa, to examine the suitability of PRT for improving the safety of whole blood transfusion, a prevalent transfusion format in the region. Results Existing literature suggests that combining PRT with current blood safety measures (such as serology) would improve the safety and adequacy of the blood supply for transfusions in sub-Saharan Africa. This was echoed by the findings of the stakeholder meetings. Conclusion Following a detailed appraisal of two leading PRT systems, the Mirasol® PRT System and the Cerus S-303 System, we suggest that companies conduct comprehensive toxicological evaluation of the agents used for PRT and publish this in the scientific literature. We also recommend that the safety and efficacy of these technologies should be established in a randomised clinical trial conducted in sub-Saharan Africa. PMID:28879109

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

    PubMed

    Morisi, G; Patriarca, M; Taggi, F

    1989-01-01

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

  9. NASA assurance terms and definitions

    NASA Technical Reports Server (NTRS)

    1993-01-01

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

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

    PubMed

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

    2007-01-01

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

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

    PubMed

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

    1994-12-01

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

  12. 75 FR 61143 - Meeting of the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-04

    ... public health parameters around safety and availability of the blood supply and blood products, (2) broad public health, ethical and legal issues related to transfusion and transplantation safety, and (3) the... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND...

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

    PubMed

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

    2010-12-01

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

  14. 76 FR 15982 - Nominations to the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-22

    ... of policy issues to include: (1) Definition of public health parameters around safety and availability of the blood supply and blood products, (2) broad public health, ethical and legal issues related...) 453-8803. FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Associate Public Health Advisor for Blood...

  15. 78 FR 12062 - Nominations to the Advisory Committee on Blood and Tissue Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-21

    ... issues for blood, organs, blood stem cells and tissues. The Committee consists of 23 voting members... products, and tissues; (3) broad public health, ethical and legal issues related to the safety of blood... the ethical standards of conduct for federal employees. Upon entering the position and annually...

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

    PubMed

    Schmitt, H

    1994-01-01

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

  17. [Blood transfusion safety in a limited resources setting: the elaboration of a rational National Blood Policy in Togo].

    PubMed

    Sodahlon, Yao K; Segbena, Akoeté Y; Prince-David, Mireille; Gbo, Kossivi A; Fargier, Marie-Paule; North, Marie-Louise; Malvy, Denis Jean-Marie

    2004-01-01

    up of a system of blood collection, storage and distribution around these centres; promotion of voluntary and anonymous blood donation; promotion of quality assurance in the system and of good blood prescription practice; development and implementation of an appropriate and simple information system for better management; identification of a sustainable and equitable financing system in which the State must play a key role. The implementation of the National Blood Policy; and in particular the achievement of its goals requires: i) permanent State commitment; ii) the building of a rational action plan - with a financing framework for all blood transfusion partners; and iii) regular program evaluation. Copyright John Libbey Eurotext 2003.

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

    PubMed Central

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

    2015-01-01

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

  19. 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.

  20. Safety and Efficacy of Unwashed Filtered Wound Drainage Blood Reinfused Following Orthopaedic Surgery

    DTIC Science & Technology

    1992-12-24

    OFFICE OF NAVAL RESEARCH CONTRACT N00014-88-C-0118 TECHNICAL REPORT 92-08 SAFETY AND EFFICACY OF UNWASHED FILTERED WOUND DRAINAGE BLOOD REINFUSED...unwashed Filtered Wound Drainage Blood Reinfused Following Orthopaedic Surgery Autologous blood products are being used increasingly to fulfill the...in whom shed blood was collected using one of two wound drainage systems, the Orth-evacTM or the SolcotransR, and reinfused postoperatively using

  1. 76 FR 26300 - Meeting of the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-06

    .... James Berger, Associate Public Health Advisor for Blood, Organ and Tissue Safety, Office of the... asked to review the WHA 63.22 on human organ and tissue transplantation and if appropriate, make... reactions on the practices, safety, quality, efficacy, epidemiology and ethics of donations...

  2. 75 FR 71444 - Renewal of Charter for the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-23

    ... and guidance includes, but is not limited to: (1) Definition of public health parameters around safety and availability of the blood and blood products; (2) broad public health, ethical, and legal issues... issues that encompass broad public health and societal implications that cannot be resolved through...

  3. Quality assurance of metabolomics.

    PubMed

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

    2015-01-01

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

  4. Accuracy and precision of four value-added blood glucose meters: the Abbott Optium, the DDI Prodigy, the HDI True Track, and the HypoGuard Assure Pro.

    PubMed

    Sheffield, Catherine A; Kane, Michael P; Bakst, Gary; Busch, Robert S; Abelseth, Jill M; Hamilton, Robert A

    2009-09-01

    This study compared the accuracy and precision of four value-added glucose meters. Finger stick glucose measurements in diabetes patients were performed using the Abbott Diabetes Care (Alameda, CA) Optium, Diagnostic Devices, Inc. (Miami, FL) DDI Prodigy, Home Diagnostics, Inc. (Fort Lauderdale, FL) HDI True Track Smart System, and Arkray, USA (Minneapolis, MN) HypoGuard Assure Pro. Finger glucose measurements were compared with laboratory reference results. Accuracy was assessed by a Clarke error grid analysis (EGA), a Parkes EGA, and within 5%, 10%, 15%, and 20% of the laboratory value criteria (chi2 analysis). Meter precision was determined by calculating absolute mean differences in glucose values between duplicate samples (Kruskal-Wallis test). Finger sticks were obtained from 125 diabetes patients, of which 90.4% were Caucasian, 51.2% were female, 83.2% had type 2 diabetes, and average age of 59 years (SD 14 years). Mean venipuncture blood glucose was 151 mg/dL (SD +/-65 mg/dL; range, 58-474 mg/dL). Clinical accuracy by Clarke EGA was demonstrated in 94% of Optium, 82% of Prodigy, 61% of True Track, and 77% of the Assure Pro samples (P < 0.05 for Optium and True Track compared to all others). By Parkes EGA, the True Track was significantly less accurate than the other meters. Within 5% accuracy was achieved in 34%, 24%, 29%, and 13%, respectively (P < 0.05 for Optium, Prodigy, and Assure Pro compared to True Track). Within 10% accuracy was significantly greater for the Optium, Prodigy, and Assure Pro compared to True Track. Significantly more Optium results demonstrated within 15% and 20% accuracy compared to the other meter systems. The HDI True Track was significantly less precise than the other meter systems. The Abbott Optium was significantly more accurate than the other meter systems, whereas the HDI True Track was significantly less accurate and less precise compared to the other meter systems.

  5. 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

  6. The Hermes safety strategy

    NASA Astrophysics Data System (ADS)

    Rosso, R.

    1992-08-01

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

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

    SciTech Connect

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

    1994-10-01

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

  8. The management of blood safety in the presence of uncertain risk: a United kingdom perspective.

    PubMed

    Watkins, Nicholas A; Dobra, Stephen; Bennett, Peter; Cairns, John; Turner, Marc L

    2012-07-01

    Millions of patients in the UK benefit from the use of both plasma derivatives and blood components that are seen as critical interventions in current medicine. Measures are in place to significantly reduce the risks associated with blood transfusion and plasma derivatives; however, these measures themselves are not risk free. Over the past 20 years, advances in technology and regulation have seen major reductions in the risks associated with transfusion. International blood services, industry, and regulators strive to maintain safety levels through constant monitoring, assessment, and response to changing risk factors. Regulation of screening tests together with the development and introduction of nucleic acid technique tests for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus has improved blood safety. However, other risks, including the changing epidemiology of transfusion-transmitted infections, bacterial contamination of platelets, incorrect blood component transfusion, and variant Creutzfeldt-Jakob disease, require further attention. Risks such as these are often complex, and there is a difficult balance to be struck between donors/recipients' benefit and adequacy of blood supply. The introduction of any new safety measure therefore requires robust, evidence-based evaluation of associated benefit, both clinical and economical. This review presents a UK perspective on how the safety of the blood supply is maintained in the face of uncertain risks. Copyright © 2012. Published by Elsevier Inc.

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

    PubMed

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

    2008-11-30

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

  10. The PARTI Architecture Assurance

    DTIC Science & Technology

    2008-10-01

    example safety critical system, 2, Issues Guidance Papers ( IGPs ) that further explain key concepts or requirements of the STAN- DARD, The guidance...Organisation (2009) IGP -OOl: Guidance Notes for Project Offices. Published as part of [20]. 4. Defence Material Organisation (2009) IGP -002: Methodsfor Safety...Architecture Analysis. Published as part of [20]. 5. Defence Material Organisation (2009) IGP -003: Methods for Design Assurance. Published as part of

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

    PubMed

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

    2012-04-01

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

  12. 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…

  13. 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).

  14. 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).

  15. Risk Evaluation and Mitigation Strategies (REMSs): Are They Improving Drug Safety? A Critical Review of REMSs Requiring Elements to Assure Safe Use (ETASU).

    PubMed

    Boudes, Pol F

    2017-06-01

    Risk Evaluation and Mitigation Strategies (REMSs) with Elements to Assure Safe Use (ETASU) are requested for drugs with significant safety risks. We reviewed REMS programs issued since 2011 to evaluate their rationales, characteristics, and consistencies, and evaluated their impact on improving drug safety. We conducted a literature search and a survey of relevant websites (FDA, manufacturers, and REMSs). ETASU characteristics were summarized. REMS risks were compared with labeled risks, including black box warnings. Forty-two programs were analyzed. Seven incorporated drugs of the same class. Most drugs (57%) were indicated for an orphan disease. A single risk was mentioned in 24 REMSs, and multiple risks in 18. Embryo-fetal toxicity and abuse or misuse were the most frequent risks. All risks were identified during clinical development but some were hypothetical. Thirty-six drugs had a black box warning. REMS risks and black box risks differed for 11 drugs. A drug with multiple indications could have a REMS for one of them but not for another. Most REMSs required prescriber training and certification, half required dispenser certification and patient enrolment. REMSs were revised multiple times and only three (7%) were discontinued. No data were available to establish whether REMSs were effective in improving drug safety. Some REMSs were deemed inefficient. REMSs with ETASU continue to be implemented but their impact on improving drug safety is still not documented. Hence, one of the main requirements of the FDA Amendments Act of 2007 is not being addressed. In addition, REMSs are complex and their logic is inconsistent; we recommend a thorough re-evaluation of the REMS program.

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

    PubMed

    Ilinskaya, Anna N; Dobrovolskaia, Marina A

    2013-06-01

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

  17. The safety of brachial artery puncture for arterial blood sampling.

    PubMed

    Okeson, G C; Wulbrecht, P H

    1998-09-01

    This study was designed to determine the incidence of complications in a sample of 6,185 brachial artery punctures for arterial blood gas analysis. The study sample was comprised of adult patients who had arterial blood gas analysis ordered in the course of their clinical evaluations in a multispecialty clinic and hospital affiliated with a university school of medicine. Subjects were entered prospectively at the time the procedure was done. The overall incidence of all complications was 2.0%. Immediate limb pain or parenthesias occurred in 1.1%, while the onset of symptoms was delayed up to 24 h in 0.9%. Hematoma formation occurred in only 0.06%. None of the complications was considered to be of major impact, in that none was associated with limb ischemia or other objective abnormalities. Only one subject required analgesic medication to control pain that ultimately subsided spontaneously without deficit. We believe that brachial artery puncture, when properly performed, is a safe and reliable alternative route for obtaining arterial blood for gas analysis.

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

    PubMed Central

    Ilinskaya, Anna N; Dobrovolskaia, Marina A

    2014-01-01

    Nanoparticle interactions with the blood coagulation system can be beneficial or adverse depending on the intended use of a nanomaterial. Nanoparticles can be engineered to be procoagulant or to carry coagulation-initiating factors to treat certain disorders. Likewise, they can be designed to be anticoagulant or to carry anticoagulant drugs to intervene in other pathological conditions in which coagulation is a concern. An overview of the coagulation system was given and a discussion of a desirable interface between this system and engineered nanomaterials was assessed in part I, which was published in the May 2013 issue of Nanomedicine. Unwanted pro- and anti-coagulant properties of nanoparticles represent significant concerns in the field of nanomedicine, and often hamper the development and transition into the clinic of many promising engineered nanocarriers. This part will focus on the undesirable effects of engineered nanomaterials on the blood coagulation system. We will discuss the relationship between the physicochemical properties of nanoparticles (e.g., size, charge and hydrophobicity) that determine their negative effects on the blood coagulation system in order to understand how manipulation of these properties can help to overcome unwanted side effects. PMID:23730696

  19. 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.

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

    PubMed Central

    Makroo, Raj Nath; Bhatia, Aakanksha

    2017-01-01

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

  1. 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

  2. Algorithm-based arterial blood sampling recognition increasing safety in point-of-care diagnostics.

    PubMed

    Peter, Jörg; Klingert, Wilfried; Klingert, Kathrin; Thiel, Karolin; Wulff, Daniel; Königsrainer, Alfred; Rosenstiel, Wolfgang; Schenk, Martin

    2017-08-04

    To detect blood withdrawal for patients with arterial blood pressure monitoring to increase patient safety and provide better sample dating. Blood pressure information obtained from a patient monitor was fed as a real-time data stream to an experimental medical framework. This framework was connected to an analytical application which observes changes in systolic, diastolic and mean pressure to determine anomalies in the continuous data stream. Detection was based on an increased mean blood pressure caused by the closing of the withdrawal three-way tap and an absence of systolic and diastolic measurements during this manipulation. For evaluation of the proposed algorithm, measured data from animal studies in healthy pigs were used. Using this novel approach for processing real-time measurement data of arterial pressure monitoring, the exact time of blood withdrawal could be successfully detected retrospectively and in real-time. The algorithm was able to detect 422 of 434 (97%) blood withdrawals for blood gas analysis in the retrospective analysis of 7 study trials. Additionally, 64 sampling events for other procedures like laboratory and activated clotting time analyses were detected. The proposed algorithm achieved a sensitivity of 0.97, a precision of 0.96 and an F1 score of 0.97. Arterial blood pressure monitoring data can be used to perform an accurate identification of individual blood samplings in order to reduce sample mix-ups and thereby increase patient safety.

  3. Algorithm-based arterial blood sampling recognition increasing safety in point-of-care diagnostics

    PubMed Central

    Peter, Jörg; Klingert, Wilfried; Klingert, Kathrin; Thiel, Karolin; Wulff, Daniel; Königsrainer, Alfred; Rosenstiel, Wolfgang; Schenk, Martin

    2017-01-01

    AIM To detect blood withdrawal for patients with arterial blood pressure monitoring to increase patient safety and provide better sample dating. METHODS Blood pressure information obtained from a patient monitor was fed as a real-time data stream to an experimental medical framework. This framework was connected to an analytical application which observes changes in systolic, diastolic and mean pressure to determine anomalies in the continuous data stream. Detection was based on an increased mean blood pressure caused by the closing of the withdrawal three-way tap and an absence of systolic and diastolic measurements during this manipulation. For evaluation of the proposed algorithm, measured data from animal studies in healthy pigs were used. RESULTS Using this novel approach for processing real-time measurement data of arterial pressure monitoring, the exact time of blood withdrawal could be successfully detected retrospectively and in real-time. The algorithm was able to detect 422 of 434 (97%) blood withdrawals for blood gas analysis in the retrospective analysis of 7 study trials. Additionally, 64 sampling events for other procedures like laboratory and activated clotting time analyses were detected. The proposed algorithm achieved a sensitivity of 0.97, a precision of 0.96 and an F1 score of 0.97. CONCLUSION Arterial blood pressure monitoring data can be used to perform an accurate identification of individual blood samplings in order to reduce sample mix-ups and thereby increase patient safety. PMID:28828302

  4. 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.

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. Emerging infectious disease agents and blood safety in Australia: spotlight on Zika virus.

    PubMed

    Kiely, Philip; Wood, Erica M; Gambhir, Manoj; Cheng, Allen C; McQuilten, Zoe K; Seed, Clive R

    2017-06-05

    Emerging infectious diseases (EIDs) are infectious diseases whose incidence has increased in humans in the past 20 years or could increase in the near future. EID agents may represent a threat to blood safety if they infect humans, cause a clinically significant illness, include an asymptomatic blood phase in the course of infection, and are transmissible by transfusion. EID agents are typically not well characterised, but there is a consensus that we can expect ongoing outbreaks. Strategies to manage the risk to blood safety from EIDs include ongoing surveillance, regular risk assessments, modelling transfusion transmission risk, and deferral of donors with a recent travel history to outbreak areas. The 2015-16 Zika virus (ZIKV) outbreak in the Americas is the largest reported ZIKV outbreak to date, and it highlights the unpredictable nature of EID outbreaks and how quickly they can become a major public health problem. This ZIKV outbreak has provided evidence of a causal link between the virus and microcephaly in newborns. In assessing the potential risk of ZIKV to blood safety in Australia, it should be noted that a relatively small number of imported ZIKV infections have been reported in Australia, there have been no reported cases of local ZIKV transmission, and the geographical distribution of the potential ZIKV mosquito vector in Australia (Aedes aegypti) is limited to northern Queensland. Moreover, reported transfusion-transmitted ZIKV cases worldwide are rare. At present, ZIKV represents a low risk to blood safety in Australia.

  11. 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.

  12. Ready-made allogeneic ABO-specific serum eye drops: production from regular male blood donors, clinical routine, safety and efficacy.

    PubMed

    Harritshøj, Lene Holm; Nielsen, Connie; Ullum, Henrik; Hansen, Morten Bagge; Julian, Hanne Olsen

    2014-12-01

    To overcome problems and delays of the preparation of autologous serum eye drops, a production line of ABO-specific allogeneic serum eye drops from male blood donors was set up in a blood bank. Feasibility, clinical routine, safety and efficacy were evaluated in a cohort of patients with severe ocular surface disorders. Serum was derived from 450 ml whole-blood donations from regular male blood donors, produced and tested according to good manufacturing practice and legislation regulating blood products in Denmark. Serum was diluted to 20% (v/v) with NaCl 0.9%, filtered, bottled, registered and stored at -30°C in the blood bank. Upon request, frozen ABO-identical serum drops in lots of 14 bottles could be provided immediately. Safety and efficacy were evaluated in 34 patients with severe ocular surface disease refractory to conventional medical therapy. Patients were treated six times daily for minimum 2-4 weeks. Objective findings and subjective symptoms were compared between day 0 and after 4 weeks of treatment using the Wilcoxon signed-rank test. Clinically, no side-effects were observed. In total, 59% of the patients with ocular surface changes improved objectively (slit-lamp examination). Partial or full healing of corneal changes, as well as subjective relief of symptoms, was observed in 16 of 20 patients with keratoconjunctivitis sicca (p < 0.001). The 14 patients with persistent epithelial defect experienced neither objective nor subjective improvements during serum treatment. Ready-made ABO-identical allogeneic serum eye drops were straightforwardly produced, quality-assured and registered as a safe standard blood product for the treatment of certain cases of severe dry eye disease. Therapeutic efficacy was comparable to previous reports on autologous serum drops. © 2014 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  13. Atlas-based and DTI-guided quantification of human brain cerebral blood flow: feasibility, quality assurance, spatial heterogeneity and age effects.

    PubMed

    Hasan, Khader M; Ali, Hiba; Shad, Mujeeb U

    2013-10-01

    Accurate and noninvasive quantification of regional cerebral blood perfusion (CBF) of the human brain tissue would advance the study of the complex interplay between human brain structure and function, in both health and disease. Despite the plethora of works on CBF in gray matter, a detailed quantitative white matter perfusion atlas has not been presented on healthy adults using the International Consortium for Brain Mapping atlases. In this study, we present a host of assurance measures such as temporal stability, spatial heterogeneity and age effects of regional and global CBF in selected deep, cortical gray matter and white matter tracts identified and quantified using diffusion tensor imaging (DTI). We utilized whole brain high-resolution DTI combined with arterial spin labeling to quantify regional CBF on 15 healthy adults aged 23.2-57.1years. We present total brain and regional CBF, corresponding volume, mean diffusivity and fractional anisotropy spatial heterogeneity, and dependence on age as additional quality assurance measures to compare with published trends using both MRI and nuclear medicine methods. Total CBF showed a steady decrease with age in gray matter (r=-0.58; P=.03), whereas total CBF of white matter did not significantly change with age (r=0.11; P=.7). This quantitative report offers a preliminary baseline of CBF, volume and DTI measurements for the design of future multicenter and clinical studies utilizing noninvasive perfusion and DT-MRI. Copyright © 2013 Elsevier Inc. All rights reserved.

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

    PubMed

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

    2016-09-01

    Standard quality assurance (QA) of cryopreserved peripheral blood stem cells (PBSC) uses post-thaw viable CD34(+) cell counts. In 2013, concerns arose at Great Ormond Street Hospital (GOSH) about 8 patients with delayed engraftment following myeloablative chemotherapy with cryopreserved cell rescue, despite adequate post-thaw viable cell counts in all cases. Root cause analysis was undertaken; investigations suggested the freeze process itself was a contributing factor to suboptimal engraftment. Experiments were undertaken in which a single PBSC product was divided into three and cryopreserved in parallel using a control-rate freezer (CRF) or passive freezing method (-80°C freezer) at GOSH, or the same passive freezing at another laboratory. Viable CD34(+) counts were equivalent and adequate in each. Granulocyte-monocyte colony-forming unit assays demonstrated colonies from the products cryopreserved using passive freezing (both laboratories), but no colonies from products cryopreserved using the CRF. The CRF was shown to be operating within manufacturer's specifications with freeze-profile within acceptable limits. This experience has important implications for quality assurance for all transplant programmes, particularly those using cryopreserved products. The failure of post-thaw viable CD34(+) counts, the most widely used routine QA test available, to ensure PBSC function is of great concern and should prompt reassessment of protocols and QA procedures. © 2016 John Wiley & Sons Ltd.

  15. Safety in the preparation of cytotoxic drugs: How to integrate gravimetric control in the quality assurance policy?

    PubMed

    Lecordier, J; Heluin, Y; Plivard, C; Bureau, A; Mouawad, C; Chaillot, B; Lahet, J-J

    2011-02-01

    We present the way to integrate gravimetric control (GC) in a centralized preparation of cytotoxic drugs unit. Two different modalities are described. In the first strategy, the balance is located inside the isolator, whereas in the second, it is located outside in order to remove many technical and ergonomic constraints. These two modalities are compared in terms of benefits and limits. GC consists in comparing the observed weight variation with the expected weight variation using a precision balance. According to the B-in strategy, this variation is directly attributable to the weight of the cytotoxic solution injected, whereas with the B-out strategy, the weight of various additional components must be taken into account. Five hundred and seventy-seven preparations have been weighed. For "B-in" strategy, the 95% confidence interval is [1.02-1.14%] and every preparation is below the threshold of 5%. For "B-out" strategy, the 95% confidence interval is [2.34-2.63%] and 94% of preparations are below the threshold of 5%. B-in strategy is distinctly more precise than B-out strategy and can be applied to all preparations. However, B-out strategy is a feasible option in practice and enables the detection of an important mistake. All in all, results obtained from B-out strategy can be considered as a quality indicator in the production line. Results of GC are helpful in the final step of release, which the pharmacist is responsible for. Many contributions in the quality assurance policy could justify using of GC in every unit. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

  16. 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.

  17. Viral safety of solvent-detergent treated blood products.

    PubMed

    Horowitz, B; Prince, A M; Horowitz, M S; Watklevicz, C

    1993-01-01

    Laboratory research commencing in 1982 led to licensing in the United States in 1985 of a solvent/detergent (SD)-treated anti-haemophilic factor (AHF) concentrate. Licensing was based on (a) studies demonstrating the inactivation of several marker viruses [vesicular stomatitis virus (VSV), Sindbis virus, Sendai virus], human immunodeficiency virus (HIV), hepatitis B virus (HBV), and non-A, non-B hepatitis virus [NANBHV; now known to be principally hepatitis C virus (HCV)] added to AHF just before treatment, (b) the realization that the principal viruses of concern in a transfusion setting (e.g. HIV, HBV, NANBHV) were all lipid-enveloped, and (c) laboratory, preclinical and clinical evidence indicating that AHF and other proteins present in the preparation were unaffected. The applicability of the SD method to a wide range of products and preparations, high process recoveries, and a growing body of viral safety information linked with the failure of several other virus inactivation methods to eliminate hepatitis transmission fostered the adoption of SD technology by more than 50 organizations world-wide. SD mixtures are now used in the preparation of products as diverse as intermediate purity and monoclonal antibody purified AHF and other coagulation factor concentrates, fibrin glue, normal and hyperimmune IgG and IgM preparations including those derived from tissue culture, plasma for transfusion, and various diagnostic controls. Over four million doses of SD-treated products have been administered, and numerous laboratory and clinical studies designed to assess virus safety have been conducted. SD treatment has been shown to inactivate > or = 10(9.2) tissue culture infectious doses (TCID50) of VSV, > or = 10(8.8) TCID50 of Sindbis virus, > or = 10(6.0) TCID50 of Sendai virus, > or = 10(7.3) duck infectious doses of duck HBV, > or = 10(11.0) degrees TCID50 of HIV-1, > or = 10(6.0) TCID50 of HIV-2, > or = 10(6.0) chimpanzee infectious doses (CID50) of HBV, > or = 10

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

    PubMed

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

    2017-01-01

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

  19. 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.

  20. 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.

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

    PubMed

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

    2017-01-01

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

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

    PubMed

    Robbins, Anthony

    2012-08-01

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

  3. Blood transfer devices for malaria rapid diagnostic tests: evaluation of accuracy, safety and ease of use

    PubMed Central

    2011-01-01

    Background Malaria rapid diagnostic tests (RDTs) are increasingly used by remote health personnel with minimal training in laboratory techniques. RDTs must, therefore, be as simple, safe and reliable as possible. Transfer of blood from the patient to the RDT is critical to safety and accuracy, and poses a significant challenge to many users. Blood transfer devices were evaluated for accuracy and precision of volume transferred, safety and ease of use, to identify the most appropriate devices for use with RDTs in routine clinical care. Methods Five devices, a loop, straw-pipette, calibrated pipette, glass capillary tube, and a new inverted cup device, were evaluated in Nigeria, the Philippines and Uganda. The 227 participating health workers used each device to transfer blood from a simulated finger-prick site to filter paper. For each transfer, the number of attempts required to collect and deposit blood and any spilling of blood during transfer were recorded. Perceptions of ease of use and safety of each device were recorded for each participant. Blood volume transferred was calculated from the area of blood spots deposited on filter paper. Results The overall mean volumes transferred by devices differed significantly from the target volume of 5 microliters (p < 0.001). The inverted cup (4.6 microliters) most closely approximated the target volume. The glass capillary was excluded from volume analysis as the estimation method used is not compatible with this device. The calibrated pipette accounted for the largest proportion of blood exposures (23/225, 10%); exposures ranged from 2% to 6% for the other four devices. The inverted cup was considered easiest to use in blood collection (206/226, 91%); the straw-pipette and calibrated pipette were rated lowest (143/225 [64%] and 135/225 [60%] respectively). Overall, the inverted cup was the most preferred device (72%, 163/227), followed by the loop (61%, 138/227). Conclusions The performance of blood transfer devices

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

    PubMed

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

    2011-04-01

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

  5. 76 FR 76732 - Nominations to the Advisory Committee on Blood Safety and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-08

    ...] [FR Doc No: 2011-31534] DEPARTMENT OF HEALTH AND HUMAN SERVICES Nominations to the Advisory Committee on Blood Safety and Availability AGENCY: Office of the Secretary, Department of Health and Human... and Human Services (HHS). Management support for the activities of this Committee is the...

  6. 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

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

    PubMed

    Heinrich, Michael

    2015-07-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2017-02-01

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

  9. Quality assurance program plan for Building 327

    SciTech Connect

    Tanke, J.M.

    1997-05-22

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

  10. NASA's Approach to Software Assurance

    NASA Technical Reports Server (NTRS)

    Wetherholt, Martha

    2015-01-01

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

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

    PubMed

    Custer, Brian; Janssen, Mart P

    2015-08-01

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

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

    PubMed

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

    2010-06-01

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

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

    PubMed

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

    2016-05-01

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

  15. Availability, safety and quality of blood for transfusion in the Americas.

    PubMed

    Cruz, José Ramiro; Pérez-Rosales, María Dolores

    2005-01-01

    This article has two objectives: (1) to present for countries and territories of the Region of the Americas data on the number of blood donations, proportion of voluntary blood donors versus remunerated blood donors, coverage of screening for infectious agents, and separation of donated blood into its components and (2) to explore the relationships of those characteristics with economic and organisational factors in the countries and territories. We carried out comparative analyses using population and health information gathered annually by the Pan American Health Organization (PAHO) from national health officials from the countries in the Americas, as well as economic information (gross national product (GNP) per capita) obtained from publications of the World Bank. There is a direct correlation between the availability of blood for transfusion and GNP per capita. Seven countries with a GNP per capita above US dollar 10,000 per year account for 38% of the Regional population but 68% of the Regional blood donations. Voluntary blood donation is more common in the countries with better blood availability. There is no association between GNP per capita and coverage of screening for infectious agents. Nevertheless, of the six countries with a GNP per capita below US dollar 1,000, only one of the six screens all units for human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B surface antigen (HBsAg). Countries with a higher proportion of voluntary blood donors tend to have lower prevalence rates of infectious markers. Separation of blood into its components is also more common in countries with higher blood donation rates. The availability, safety and quality of blood for transfusion in the Americas needs to be improved. As part of that effort, national policies and strategies must be put into place so that the resources already allocated for blood services are better utilised.

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

    PubMed

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

    2015-07-29

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

  17. Assurance of safety of recycled paperboard for food packaging through comprehensive analysis of potential migrants is unrealistic.

    PubMed

    Biedermann, Maurus; Grob, Koni

    2013-06-07

    A method for determining potentially health-relevant components in paperboard used for packaging dry foods as comprehensively as technically feasible was applied to a sample of recycled paperboard. The task was specified by a detection limit in food of 0.01mg/kg, from which a detection limit of 0.1mg/kg in paperboard was derived. Extracts from the paperboard were preseparated into seven fractions by high performance liquid chromatography (HPLC) and transferred on-line to gas chromatography with flame ionization detection (GC-FID). The chromatograms visualize the high complexity of the material that may migrate into foods at toxicologically potentially relevant concentrations. Since only a minority of the substances was also detectable in fresh fiber board, most must have originated from chemicals used in the paper and board fed into the recycling process. Significant variability between recycled paperboards of four manufacturers was observed because of varying feedstocks. Using comprehensive two-dimensional GC (GC×GC) with time of flight mass spectrometry (TOF-MS), more than 250 substances were counted that probably exceeded the detection limit and were probably of sufficient volatility for migration into dry food. It is concluded in three main messages to risk managers: (i) since most potential migrants have not been adequately evaluated, many not even identified, the safety required by Article 3 of EU Regulation 1935/2004 has not been ensured; (ii) the number of substances potentially migrating into food above 0.01mg/kg is too large to realistically be brought under control; (iii) a barrier reducing the migration into food by a factor of 100 over the life time of a product would keep the migration of all except a few well known substances below 0.01mg/kg in food. Copyright © 2013 Elsevier B.V. All rights reserved.

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

    PubMed

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

    2006-02-01

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

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

    PubMed

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

    2006-07-01

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

  20. The Center for HIV/AIDS Vaccine Immunology (CHAVI) Multi-site Quality Assurance Program for Cryopreserved Human Peripheral Blood Mononuclear Cells

    PubMed Central

    Sarzotti-Kelsoe, Marcella; Needham, Leila K.; Rountree, Wes; Bainbridge, John; Gray, Clive M.; Fiscus, Susan A.; Ferrari, Guido; Stevens, Wendy S.; Stager, Susan L.; Binz, Whitney; Louzao, Raul; Long, Kristy O.; Mokgotho, Pauline; Moodley, Niranjini; Mackay, Melanie; Kerkau, Melissa; McMillion, Takesha; Kirchherr, Jennifer; Soderberg, Kelly A.; Haynes, Barton F.; Denny, Thomas N.

    2014-01-01

    The Center for HIV/AIDS Vaccine Immunology (CHAVI) consortium was established to determine the host and virus factors associated with HIV transmission, infection and containment of virus replication, with the goal of advancing the development of an HIV protective vaccine. Studies to meet this goal required the use of cryopreserved Peripheral Blood Mononuclear Cell (PBMC) specimens, and therefore it was imperative that a quality assurance (QA) oversight program be developed to monitor PBMC samples obtained from study participants at multiple international sites. Nine site-affiliated laboratories in Africa and the USA collected and processed PBMCs, and cryopreserved PBMC were shipped to CHAVI repositories in Africa and the USA for long-term storage. A three-stage program was designed, based on Good Clinical Laboratory Practices (GCLP), to monitor PBMC integrity at each step of this process. The first stage evaluated the integrity of fresh PBMCs for initial viability, overall yield, and processing time at the site-affiliated laboratories (Stage 1); for the second stage, the repositories determined post-thaw viability and cell recovery of cryopreserved PBMC, received from the site-affiliated laboratories (Stage 2); the third stage assessed the long-term specimen storage at each repository (Stage 3). Overall, the CHAVI PBMC QA oversight program results highlight the relative importance of each of these stages to the ultimate goal of preserving specimen integrity from peripheral blood collection to long-term repository storage. PMID:24910414

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

    PubMed

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

    2014-01-01

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

  2. 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

  3. 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.

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

    PubMed

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

    2013-05-01

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

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

    PubMed

    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

    2015-09-01

    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. 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). 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. 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.

  6. 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

  7. Quality assurance and quality control of thrombelastography and rotational Thromboelastometry: the UK NEQAS for blood coagulation experience.

    PubMed

    Kitchen, Dianne P; Kitchen, Steve; Jennings, Ian; Woods, Tim; Walker, Isobel

    2010-10-01

    Global hemostasis devices are currently being employed in operating rooms to assess the bleeding risk and outcomes for patients undergoing surgery. Two devices currently available are the TEG (Thromboelastograph; Haemoscope Corp., Niles, IL) and the ROTEM (Rotation Thromboelastometer; Pentapharm GmbH, Munich, Germany). Both measure the speed of clot formation, the strength of the clot when formed, and clot fibrinolysis kinetics. The two devices use different parameters so no cross comparisons of results can be made. The devices are usually operated by a member of the operating team and not a laboratory scientist; thus their testing and performance is generally not laboratory controlled, despite quality control being required to ensure reliable results. The UK National External Quality Assessment Scheme (NEQAS) for Blood Coagulation has undertaken a series of exercises evaluating the provision of External Quality Assessment (EQA) material for these devices. A series of four studies have taken place using lyophilized plasmas as the test material. Up to 18 TEG users and 10 ROTEM users have been involved in testing two samples per study, for a total of eight samples tested. The samples were normal plasmas, factor VIII or XI deficient samples, or normal plasmas spiked with heparin. The precision of the tests varied greatly for both devices, with coefficients of variances ranging from 7.1 to 39.9% for TEG and 7.0 to 83.6% for ROTEM. Some centers returned results that were sufficiently different from those obtained by other participants to predict alterations in patient management decisions. Our data indicate that regular EQA/proficiency testing is needed for these devices. © Thieme Medical Publishers.

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

    PubMed

    Cazenave, Jean-Pierre

    2006-01-01

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

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

    PubMed

    Rojo Medina, Julieta

    2014-01-01

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

  10. Quality Interaction Between Mission Assurance and Project Team Members

    NASA Technical Reports Server (NTRS)

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

    2006-01-01

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

  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.

  12. Utilizing Radiofrequency Identification Technology to Improve Safety and Management of Blood Bank Supply Chains.

    PubMed

    Coustasse, Alberto; Meadows, Pamela; Hall, Robert S; Hibner, Travis; Deslich, Stacie

    2015-11-01

    The importance of efficiency in the supply chain of perishable products, such as the blood products used in transfusion services, cannot be overstated. Many problems can occur, such as the outdating of products, inventory management issues, patient misidentification, and mistransfusion. The purpose of this article was to identify the benefits and barriers associated with radiofrequency identification (RFID) usage in improving the blood bank supply chain. The methodology for this study was a qualitative literature review following a systematic approach. The review was limited to sources published from 2000 to 2014 in the English language. Sixty-five sources were found, and 56 were used in this research study. According to the finding of the present study, there are numerous benefits and barriers to RFID utilization in blood bank supply chains. RFID technology offers several benefits with regard to blood bank product management, including decreased transfusion errors, reduction of product loss, and more efficient inventory management. Barriers to RFID implementation include the cost associated with system implementation and patient privacy issues. Implementation of an RFID system can be a significant investment. However, when observing the positive impact that such systems may have on transfusion safety and inventory management, the cost associated with RFID systems can easily be justified. RFID in blood bank inventory management is vital to ensuring efficient product inventory management and positive patient outcomes.

  13. Blood Cytokines as Biomarkers of In Vivo Toxicity in Preclinical Safety Assessment: Considerations for Their Use

    PubMed Central

    Tarrant, Jacqueline M.

    2010-01-01

    In the drive to develop drugs with well-characterized and clinically monitorable safety profiles, there is incentive to expand the repertoire of safety biomarkers for toxicities without routine markers or premonitory detection. Biomarkers in blood are pursued because of specimen accessibility, opportunity for serial monitoring, quantitative measurement, and the availability of assay platforms. Cytokines, chemokines, and growth factors (here referred to collectively as cytokines) show robust modulation in proximal events of inflammation, immune response, and repair. These are key general processes in many toxicities; therefore, cytokines are commonly identified during biomarker discovery studies. In addition, multiplexed cytokine immunoassays are easily applied to biomarker discovery and routine toxicity studies to measure blood cytokines. However, cytokines pose several challenges as safety biomarkers because of a short serum half-life; low to undetectable baseline levels; lack of tissue-specific or toxicity-specific expression; complexities related to cytokine expression with multiorgan involvement; and species, strain, and interindividual differences. Additional challenges to their application are caused by analytical, methodological, and study design–related variables. A final consideration is the strength of the relationship between changes in cytokine levels and the development of phenotypic or functional manifestations of toxicity. These factors should inform the integrated judgment-based qualification of novel biomarkers in preclinical, and potentially clinical, risk assessment. The dearth of robust, predictive cytokine biomarkers for specific toxicities is an indication of the significant complexity of these challenges. This review will consider the current state of the science and recommendations for appropriate application of cytokines in preclinical safety assessment. PMID:20447938

  14. 30 CFR 15.8 - Quality assurance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Quality assurance. 15.8 Section 15.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... § 15.8 Quality assurance. (a) Applicants granted an approval or an extension of approval under...

  15. 30 CFR 7.7 - Quality assurance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Quality assurance. 7.7 Section 7.7 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY General § 7.7 Quality assurance. Applicants...

  16. 30 CFR 14.8 - Quality assurance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

  17. 30 CFR 15.8 - Quality assurance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Quality assurance. 15.8 Section 15.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... § 15.8 Quality assurance. (a) Applicants granted an approval or an extension of approval under...

  18. 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...

  19. 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...

  20. 30 CFR 15.8 - Quality assurance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Quality assurance. 15.8 Section 15.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... § 15.8 Quality assurance. (a) Applicants granted an approval or an extension of approval under...

  1. 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...

  2. 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...

  3. 30 CFR 7.7 - Quality assurance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Quality assurance. 7.7 Section 7.7 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY General § 7.7 Quality assurance. Applicants...

  4. 30 CFR 7.7 - Quality assurance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Quality assurance. 7.7 Section 7.7 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY General § 7.7 Quality assurance. Applicants...

  5. 30 CFR 14.8 - Quality assurance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  6. Quality Assurance: One School's Response.

    ERIC Educational Resources Information Center

    Wittemann, K. Joseph

    1990-01-01

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

  7. 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. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. Making whole blood available in austere medical environments: donor performance and safety.

    PubMed

    Eliassen, Håkon S; Aandstad, Anders; Bjerkvig, Christopher; Fosse, Theodor; Audun Hervig, Tor; Pidcoke, Heather F; Strandenes, Geir

    2016-04-01

    To provide whole blood on the battlefield can be a challenge, but a buddy system protocol is both an elegant and the only currently available means to supply blood to a Special Forces team in far-forward locations. Our aim was to investigate donor-safety associated with such a protocol. This study was a randomized, double-blinded, controlled trial that aimed to evaluate the immediate effects of a 450 cc blood donation on physical performance in fatigued and dehydrated Special Forces soldiers. The primary outcome variables were absolute and relative maximal oxygen uptake (VO2max ), exercise tolerance time (ETT) and heart rate (HR). Relative VO2max decreased by 7.1% in the donation group between pre and posttest, compared to no change in the control group. Absolute VO2max decreased by 11.2 and 3.6% between pre and posttest in the donation and control groups, respectively. Mean ETT in the donation group was on average 92 seconds shorter compared to baseline, which represents a decrease of 9.5%. Donating blood after a week of strenuous physical activity is feasible for Special Forces personnel. While the donation results in some diminishment of VO2max , a 3.6%-11.2% decrease in relative VO2max , and in elevation of submaximal HR levels highly trained personnel continue to perform well both at both sub-maximal and maximal effort levels. © 2016 AABB.

  9. Assuring quality.

    PubMed

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

    2008-08-09

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

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

    PubMed

    Cheung, Tommy Tsang; Cheung, Bernard Man Yung

    2014-01-01

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

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

    PubMed

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

    2013-03-01

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

  12. 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.

  13. 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.

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

    NASA Astrophysics Data System (ADS)

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

    2010-03-01

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

  15. Quality assurance in bariatric surgery.

    PubMed

    Rendon, Stewart E; Pories, Walter J

    2005-08-01

    Quality assurance is a function that exists in manufacturing,engineering, and the service industry. Bariatric surgery is an undertaking with a special form of consumer product and service. In this day of limited resources and significant value exchanges among stakeholders (ie, patients, surgeons, third-party payers),the goal of the bariatric community is to deliver quality outcomes with safety, efficacy, and efficiency. The American Society for Bariatric Surgery and the Surgical Review Corporation, in conjunction with the bariatric community, will use quality assurance methods to produce quality outcomes that will satisfy the value exchanges of all stakeholders.

  16. 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…

  17. 10 CFR 830.122 - Quality assurance criteria.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

  18. 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...

  19. 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...

  20. 49 CFR 180.505 - Quality assurance program.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

  2. 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...

  3. 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 program...

  4. Efficacy and safety profile of autologous blood versus tetracycline pleurodesis for malignant pleural effusion.

    PubMed

    Keeratichananont, Warangkana; Limthon, Theeranan; Keeratichananont, Suriya

    2015-04-01

    Autologous blood pleurodesis (ABP) is used for the treatment of pneumothorax with a good efficacy. The aim of this study is to determine the efficacy and safety of ABP in the treatment of malignant pleural effusion (MPE). A prospective study was conducted at Songklanagarind Hospital, Thailand. Symptomatic MPE patients were randomized to receive pleurodesis with either autologous blood or tetracycline. In the ABP group, 100 ml of autologous venous blood was instilled via chest tube followed by 50 ml of sterile normal saline (NSS). In the tetracycline group, 20 ml of 1% lidocaine diluted in 30 ml NSS was instilled followed by 1 g of tetracycline diluted in 100 ml of NSS. The chest tube was clamped for 2 hours, then reconnected to suction and removed. Pleurodesis effectiveness was evaluated according to Paladine's criteria and adverse events were recorded. A total of 48 symptomatic MPE patients were recruited. Of these, 24 cases were randomized to receive ABP and 24 cases received tetracycline. There was no difference between the two groups in baseline characteristics. The overall success rate of pleurodesis was the same in both the autologous blood group and the tetracycline group (83.4% versus 87.5%, p = 0.36). In the ABP group, the pain score and fever were significantly lower (8.3% versus 29.1%, p = 0.003) and there was a small percentage of cases that needed analgesia (4.2% versus 75%, p < 0.001); no serious events occurred. ABP was as effective as tetracycline in the treatment of MPE. ABP produced less pain and fever, and could shorten the hospital stay. © The Author(s), 2015.

  5. The comparison of heparinized insulin syringes and safety-engineered blood gas syringes used in arterial blood gas sampling in the ED setting (randomized controlled study).

    PubMed

    Baskın, Sevcan Baki; Oray, Neşe Çolak; Yanturalı, Sedat; Bayram, Başak

    2014-05-01

    The arterial blood gas measurement process is a painful and invasive procedure, often uncomfortable for both the patient and the physician. Because the patient-related factors that determine the difficulty of the process cannot be controlled, the physician-related factors and blood gas measurement techniques are a modifiable area of improvement that ought to be considered. Many hospitals use insulin syringes or syringes washed with heparin for the purpose of blood gas measurement because they do not have blood gas-specific syringes. In this prospective cross-sectional study, we aimed to compare safety-engineered blood gas syringes and conventional heparinized syringes used during the arterial blood gas extraction process in terms of ease of operation, the physician-patient satisfaction, laboratory appropriateness, and complications. Our study included patients whose arterial blood gas needed to be measured in the emergency department and who agreed to participate in the study. Patients were randomly divided into 2 groups. The arterial blood gas of the patients from the first group was measured by using conventional heparinized syringes, whereas safety-engineered blood gas syringes were used to measure the arterial blood gas of the patients from the second group. The groups were compared in terms of demographic data, the number of attempts, the physician and patient satisfaction, early and late-term complications, and laboratory appropriateness of the taken sample. A total of 550 patients were included in our study in a 2-month study period. There were no significant differences between patients in terms of sex, age, weight, height, body mass index, and wrist circumference. In addition, the number of attempts (P=.489), patients' pain level during the procedure (P=.145), and the degree of difficulty of the procedure according to the patient (P=.109) and physician (P=.554) were not significantly different between the groups. After arterial blood gas extraction

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

    PubMed

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

    2011-04-22

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

  7. [Usefulness of reticulocyte hemoglobin equivalent for the safety of pre-operative autologous blood donation].

    PubMed

    Shibayama, Masami; Takami, Akiyoshi; Kimura, Mika; Takamichi, Sayuri; Sakai, Yoshio; Wada, Takashi

    2011-06-01

    Pre-operative autologous blood donation (PABD) provides safe blood for patients at the expense of the risk of iron deficiency anemia that may compromise the patients. The reticulocyte hemoglobin equivalent (RET-He) is an indirect measure of the functional iron available for the erythropoiesis over the previous 2-3 days. The aim of this study was to evaluate the clinical usefulness of RET-He quickly measured by the automated hematology analyzer Sysmex XE-2100 in patients undergoing PABD at our hospital. Receiver-operating characteristic curve analysis revealed that RET-He was reliable in the diagnosis of iron deficiency anemia. Two of 14 patients in the absence of post-PABD iron replacement developed marked anemia with low RET-He levels after PABD, suggesting that this anemia was due to iron deficiency. Of 26 patients receiving post-PABD iron replacement, 8 who had already showed low RET-He levels at PABD developed statistically significant reduction in hemoglobin levels after PABD despite adequate iron replacement, indicating that the 8 patients had iron deficiency prior to PABD. These findings suggest that automated measurement of RET-He may contribute to improve the safety of PABD.

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

    PubMed Central

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

    2011-01-01

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

  9. 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.

  10. Efficiency and safety of tranexamic acid in reducing blood loss in total shoulder arthroplasty

    PubMed Central

    Sun, Chuan-Xiu; Zhang, Lu; Mi, Li-Dong; Du, Guang-Yu; Sun, Xue-Gang; He, Sheng-Wei

    2017-01-01

    Abstract Objective: This meta-analysis aimed to evaluate the efficiency and safety of tranexamic acid for reducing blood loss and transfusion requirements in patients undergoing total shoulder arthroplasty. Methods: A systematic search was performed in Embase (1980–2017.04, embase.com), Medline (1966–2017.04, medline.com), PubMed (1966–2017.04, pubmed.com), ScienceDirect (1985–2017.04, sciencedirect.com), and Web of Science (1950–2017.04, webofknowledge.com). Study which assessed the efficiency and safety of tranexamic acid in total shoulder arthroplasty was selected. Meta-analysis was performed using Stata 11.0 software. Results: In all, 484 patients from 2 randomized controlled trials (RCTs) and 2 non-RCTs were subjected to meta-analysis. The present meta-analysis demonstrated that there was less total blood loss (mean difference [MD] −172.16, 95% confidence interval [CI] −35.46 to −308.87, P = .01, d = 0.33) and transfusion rate (odds ratio 0.34, 95% CI 0.13 to 0.91, P = .03, d = 0.29) in tranexamic acid groups compared with the control groups. There were no significant differences in duration of surgery (MD 0.02, 95% CI −0.12 to 0.22, P = .89, d = 0.19), length of stay (MD −0.06, 95% CI −0.26 to 0.14, P = .56, d = 0.20), or incidence of adverse effects such as deep venous thrombosis (odds ratio 1.15, 95% CI 0.33 to 4.00, P = .83, d = 0.53). Conclusion: Clinical application of tranexamic acid seemed to result in significant reductions in total blood loss, hemoglobin decline and transfusion requirements following total shoulder arthroplasty. Moreover, no increased risk of the thrombotic events was identified. Due to the limited quality of the evidence currently available, higher quality RCTs are required. PMID:28562553

  11. 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

  12. 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

    ... (23 U.S.C. CHAPTER 4) A APPENDIX A TO PART 1200 Highways NATIONAL HIGHWAY TRAFFIC SAFETY... basis of sex; (c) Section 504 of the Rehabilitation Act of 1973, as amended (29 U.S.C. 794), and the... company-owned, rented, or personally-owned vehicles. The National Highway Traffic Safety...

  13. 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

    ... (23 U.S.C. Chapter 4) A Appendix A to Part 1200 Highways NATIONAL HIGHWAY TRAFFIC SAFETY... basis of sex; (c) Section 504 of the Rehabilitation Act of 1973, as amended (29 U.S.C. 794), and the... company-owned, rented, or personally-owned vehicles. The National Highway Traffic Safety...

  14. 23 CFR Appendix D to Part 1200 - CERTIFICATIONS AND ASSURANCES FOR NATIONAL PRIORITY SAFETY PROGRAM GRANTS (23 U.S.C. 405)

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... regulation requires all fees collected by the State from motorcyclists for the purpose of funding motorcycle... motorcyclists for the purpose of funding motorcycle training and safety programs be spent on motorcycle training... motorcyclists for the purpose of funding motorcycle training and safety programs were used for motorcycle...

  15. 23 CFR Appendix D to Part 1200 - Certifications and Assurances for National Priority Safety Program Grants (23 U.S.C. 405)

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... regulation requires all fees collected by the State from motorcyclists for the purpose of funding motorcycle... motorcyclists for the purpose of funding motorcycle training and safety programs be spent on motorcycle training... motorcyclists for the purpose of funding motorcycle training and safety programs were used for motorcycle...

  16. 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... affect, or may affect, the nuclear safety of DOE nuclear facilities must conduct work in accordance with...

  17. 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... affect, or may affect, the nuclear safety of DOE nuclear facilities must conduct work in accordance with...

  18. 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... affect, or may affect, the nuclear safety of DOE nuclear facilities must conduct work in accordance with...

  19. 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.

  20. Acute effects of electromagnetic stimulation of the brain on cortical activity, cortical blood flow, blood pressure and heart rate in the cat: an evaluation of safety.

    PubMed Central

    Eyre, J A; Flecknell, P A; Kenyon, B R; Koh, T H; Miller, S

    1990-01-01

    The influence of repeated high intensity electromagnetic stimulation of the brain on cortical activity, cortical blood flow, blood pressure and heart rate has been investigated in the cat, to evaluate the safety of the method. The observations have been made in preparations under propofol anaesthesia before, during and after periods of anoxia. Electromagnetic stimulation of the brain evoked activity in descending motor pathways and was recorded by activity in the median nerve and by muscle twitches. Following repeated series of high intensity stimulation there were no systematic changes in somatosensory evoked potentials or background EEG, nor were there signs of epileptogenic activity during electromagnetic stimulation, before, during or after periods of anoxia. No systematic changes in cortical blood flow, blood pressure or heart rate were observed during electromagnetic stimulation, before or after periods of anoxia. In conclusion, no acute adverse consequences following electromagnetic stimulation in the normal and anoxic cat brain were demonstrated. PMID:2380732

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

    PubMed

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

    2015-06-01

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

  2. Beef Quality Assurance in Feedlots.

    PubMed

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

    2015-07-01

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

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

    PubMed

    Seghatchian, Jerard

    2015-04-01

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

  4. 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.

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

    PubMed

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

    2013-12-01

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

  6. Safety of recombinant human factor XIII in a cynomolgus monkey model of extracorporeal blood circulation.

    PubMed

    Ponce, R; Armstrong, K; Andrews, K; Hensler, J; Waggie, K; Heffernan, J; Reynolds, T; Rogge, M

    2005-01-01

    Factor XIII (FXIII) is a thrombin-activated plasma coagulation factor critical for blood clot stabilization and longevity. Administration of exogenous FXIII to replenish depleted stores after major surgery, including cardiopulmonary bypass, may reduce bleeding complications and transfusion requirements. Thus, a model of extracorporeal circulation (ECC) was developed in adult male cynomolgus monkeys (Macaca fascicularis) to evaluate the nonclinical safety of recombinant human FXIII (rFXIII). The hematological and coagulation profile in study animals during and after 2 h of ECC was similar to that reported for humans during and after cardiopulmonary bypass, including observations of anemia, thrombocytopenia, and activation of coagulation and platelets. Intravenous slow bolus injection of 300 U/kg (2.1 mg/kg) or 1000 U/kg (7 mg/kg) rFXIII after 2 h of ECC was well tolerated in study animals, and was associated with a dose-dependent increase in FXIII activity. No clinically significant effects in respiration, ECG, heart rate, blood pressure, body temperature, clinical chemistry, hematology (including platelet counts), or indicators of thrombosis (thrombin:anti-thrombin complex and D-Dimer) or platelet activation (platelet factor 4 and beta-thromboglobulin) were related to rFXIII administration. Specific examination of brain, heart, lung, liver, and kidney from rFXIII-treated animals provided no evidence of histopathological alterations suggestive of subclinical hemorrhage or thrombosis. Taken as a whole, the results demonstrate the ECC model suitably replicated the clinical presentation reported for humans during and after cardiopulmonary bypass surgery, and do not suggest significant concerns regarding use of rFXIII in replacement therapy after extracorporeal circulation.

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

    PubMed

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

    2017-03-31

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

  8. 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.

  9. Initial safety and feasibility of cold-stored uncrossmatched whole blood transfusion in civilian trauma patients.

    PubMed

    Yazer, Mark H; Jackson, Byron; Sperry, Jason L; Alarcon, Louis; Triulzi, Darrell J; Murdock, Alan D

    2016-07-01

    The transfusion of cold-stored uncrossmatched whole blood (WB) has not been extensively used in civilian trauma resuscitation. This report details the initial experience with the safety and feasibility of using WB in this setting after a change of practice at a Level 1 trauma center was instituted. Up to two units of uncrossmatched group O positive WB that was leukoreduced using a platelet-sparing filter from male donors were transfused to male trauma patients with hypotension secondary to bleeding. Hemolytic marker haptoglobin and reports of transfusion reactions in these patients were followed. Additionally, transfusion volumes and outcomes were compared to a historical cohort of male trauma patients who received at least one red blood cell (RBC) unit, but not WB, during the first 24 hours of admission. There were 47 WB patients who were transfused with a mean (SD) of 1.74 (0.61) WB units. The median haptoglobin concentration on post-WB transfusion Day 1 was 25.1 (9.3) mg/dL in 7 of 30 non-group O recipients. No adverse reactions in temporal relation to the WB transfusions were reported. There were 145 male historical control patients identified who were resuscitated with component therapy; the median volume of incompatible plasma transfused to the WB versus component therapy group was not significantly different (1,000 vs. 800 mL, respectively; p = 0.38); the mean plasma:RBC (0.99 [0.47] vs. 0.77 [ 0.73], respectively; p = 0.006) and platelet:RBC (0.72 [0.40] vs. 0.51 [0.734], respectively; p < 0.0001) ratios were significantly higher in the WB group. Transfusion of two units of cold-stored uncrossmatched WB is feasible and seems to be safe in civilian trauma resuscitation. Determining the efficacy of WB with regard to reducing the number of blood products transfused in the first 24 hours or improving recipient survival will require a larger randomized trial. Therapeutic study, level IV.

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

    PubMed

    Admiraal, R; Boelens, J J

    2016-06-01

    The conditioning regimen used in cord blood transplantation (CBT) may significantly impact the outcomes. Variable pharmacokinetics (PK) of drugs used may further influence outcome. Individualized dosing takes inter-patient differences in PK into account, tailoring drug dose for each individual patient in order to reach optimal exposure. Dose individualization may result in a better predictable regimen in terms of safety and efficacy, including timely T cell reconstitution, which may result in improved survival chances. Conditioning regimens used in CBT varies significantly between and within centres. For busulfan, individualized dosing with therapeutic drug monitoring has resulted in better outcomes. Anti-thymocyte globulin (ATG), used to prevent rejection and GvHD, significantly hampers early T-cell reconstitution (IR). Timely IR is crucial in preventing viral reactivations and relapse. By individudalizing ATG, IR is better predicted and may prevent morbidity and mortality. Individualization of agents used in the conditioning regimen in CBT has proven its added value. Further fine-tuning, including new drugs and/or comprehensive models for all drugs, may result in better predictable conditioning regimens. A predictable conditioning regimen is also of interest/importance when studying adjuvant therapies, including immunotherapies (e.g. cellular vaccines or engineered T-cell) in a harmonized clinical trial design setting.

  11. 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

  12. Challenges in High-Assurance Runtime Verification

    NASA Technical Reports Server (NTRS)

    Goodloe, Alwyn E.

    2016-01-01

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

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

    PubMed

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

    2011-06-01

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

  14. Compliance Assurance Monitoring

    EPA Pesticide Factsheets

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

  15. 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.

  16. Blood

    MedlinePlus

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

  17. 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…

  18. 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.

  19. 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.

  20. KENNEDY SPACE CENTER, FLA. - NASA officials brief the media at KSC about the agency’s human space flight program. At left is moderator Allard Beutel, with NASA Headquarters. Others on the panel (left to right) are NASA Deputy Administrator Fred Gregory, Associate Administrator for Space Flight Bill Readdy and Associate Administrator for Safety and Mission Assurance Bryan O’Connor.

    NASA Image and Video Library

    2003-08-05

    KENNEDY SPACE CENTER, FLA. - NASA officials brief the media at KSC about the agency’s human space flight program. At left is moderator Allard Beutel, with NASA Headquarters. Others on the panel (left to right) are NASA Deputy Administrator Fred Gregory, Associate Administrator for Space Flight Bill Readdy and Associate Administrator for Safety and Mission Assurance Bryan O’Connor.

  1. KENNEDY SPACE CENTER, FLA. - NASA officials brief the media at KSC about the agency’s human space flight program. On the panel (left to right) are NASA Deputy Administrator Fred Gregory, Associate Administrator for Space Flight Bill Readdy and Associate Administrator for Safety and Mission Assurance Bryan O’Connor.

    NASA Image and Video Library

    2003-08-05

    KENNEDY SPACE CENTER, FLA. - NASA officials brief the media at KSC about the agency’s human space flight program. On the panel (left to right) are NASA Deputy Administrator Fred Gregory, Associate Administrator for Space Flight Bill Readdy and Associate Administrator for Safety and Mission Assurance Bryan O’Connor.

  2. Rebuilding a safety culture

    NASA Astrophysics Data System (ADS)

    Rodney, George A.

    1991-11-01

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

  3. [Quality assurance in human genetic testing].

    PubMed

    Stuhrmann-Spangenberg, Manfred

    2015-02-01

    Advances in technical developments of genetic diagnostics for more than 50 years, as well as the fact that human genetic testing is usually performed only once in a lifetime, with additional impact for blood relatives, are determining the extraordinary importance of quality assurance in human genetic testing. Abidance of laws, directives, and guidelines plays a major role. This article aims to present the major laws, directives, and guidelines with respect to quality assurance of human genetic testing, paying careful attention to internal and external quality assurance. The information on quality assurance of human genetic testing was obtained through a web-based search of the web pages that are referred to in this article. Further information was retrieved from publications in the German Society of Human Genetics and through a PubMed-search using term quality + assurance + genetic + diagnostics. The most important laws, directives, and guidelines for quality assurance of human genetic testing are the gene diagnostics law (GenDG), the directive of the Federal Medical Council for quality control of clinical laboratory analysis (RiliBÄK), and the S2K guideline for human genetic diagnostics and counselling. In addition, voluntary accreditation under DIN EN ISO 15189:2013 offers a most recommended contribution towards quality assurance of human genetic testing. Legal restraints on quality assurance of human genetic testing as mentioned in § 5 GenDG are fulfilled once RiliBÄK requirements are followed.

  4. 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.

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

    SciTech Connect

    Khericha, 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.

  6. 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)

  7. 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)

  8. Blood

    MedlinePlus

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

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

    PubMed

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

    2003-01-01

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

  10. 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.

  11. 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.

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

    SciTech Connect

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

    1991-10-01

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

  13. 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.

  14. Hanford Tanks Initiative quality assurance implementation plan

    SciTech Connect

    Huston, J.J.

    1998-06-23

    Hanford Tanks Initiative (HTI) Quality Assurance Implementation Plan for Nuclear Facilities defines the controls for the products and activities developed by HTI. Project Hanford Management Contract (PHMC) Quality Assurance Program Description (QAPD)(HNF-PRO599) is the document that defines the quality requirements for Nuclear Facilities. The QAPD provides direction for compliance to 10 CFR 830.120 Nuclear Safety Management, Quality Assurance Requirements. Hanford Tanks Initiative (HTI) is a five-year activity resulting from the technical and financial partnership of the US Department of Energy`s Office of Waste Management (EM-30), and Office of Science and Technology Development (EM-50). HTI will develop and demonstrate technologies and processes for characterization and retrieval of single shell tank waste. Activities and products associated with HTI consist of engineering, construction, procurement, closure, retrieval, characterization, and safety and licensing.

  15. Small satellite product assurance

    NASA Astrophysics Data System (ADS)

    Demontlivault, J.; Cadelec, Jacques

    1993-01-01

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

  16. Explore The NASA Safety Center

    NASA Image and Video Library

    2015-07-01

    The NASA Safety Center (NSC) reports to NASA’s Office of Safety and Mission Assurance and supports the Safety and Mission Assurance (SMA) requirements of NASA’s portfolio of programs and projects. The NSC focuses on development of the personnel, processes and tools needed for the safe and successful achievement of NASA’s strategic goals.

  17. 40 CFR 1603.5 - Assurance of compliance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  18. 20 CFR 655.203 - Assurances.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  19. [Design of a Hazard Analysis and Critical Control Points (HACCP) plan to assure the safety of a bologna product produced by a meat processing plant].

    PubMed

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

    2004-03-01

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

  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.

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

    PubMed

    Ramasubramanian, M K; Anthony, Steven R

    2004-01-01

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

  2. 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

  3. 10 CFR 72.142 - Quality assurance organization.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  4. 10 CFR 72.142 - Quality assurance organization.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  5. 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…

  6. Software Assurance Competency Model

    DTIC Science & Technology

    2013-03-01

    2010a]: Application of technologies and processes to achieve a required level of confidence that software systems and services function in the...for specific projects. L5: Analyze assurance technologies and contribute to the development of new ones. Assured Software Development L1

  7. Why Quality Assurance?

    PubMed Central

    Alexander, Leslie L.; Lewis, Nathan

    1981-01-01

    Quality assurance programs in radiology are essential and each radiologist must be committed to exert comprehensive efforts toward excellent quality control. Identification and evaluation of a radiological problem, corrective action, and good record keeping are essential features of a well-managed quality assurance program. This paper discusses the background and impact of these programs on providing safe radiologic services to patients. PMID:7218367

  8. Hepatitis E and blood donation safety in selected European countries: a shift to screening?

    PubMed Central

    Domanović, Dragoslav; Tedder, Richard; Blümel, Johannes; Zaaijer, Hans; Gallian, Pierre; Niederhauser, Christoph; Sauleda Oliveras, Silvia; O’Riordan, Joan; Boland, Fiona; Harritshøj, Lene; Nascimento, Maria São José; Ciccaglione, Anna Rita; Politis, Constatina; Adlhoch, Cornelia; Flan, Benoit; Oualikene-Gonin, Wahiba; Rautmann, Guy; Strengers, Paul; Hewitt, Patricia

    2017-01-01

    The public health implications of hepatitis E virus (HEV) in Europe have changed due to increasing numbers of hepatitis E cases and recent reports of chronic, persistent HEV infections associated with progression to cirrhosis in immunosuppressed patients. The main infectious risk for such immunosuppressed patients is exposure to undercooked infected pork products and blood transfusion. We summarised the epidemiology of HEV infections among blood donors and also outlined any strategies to prevent transfusion-transmitted HEV, in 11 European countries. In response to the threat posed by HEV and related public and political concerns, most of the observed countries determined seroprevalence of HEV in donors and presence of HEV RNA in blood donations. France, Germany, Spain and the United Kingdom (UK) reported cases of transfusion-transmitted HEV. Ireland and the UK have already implemented HEV RNA screening of blood donations; the Netherlands will start in 2017. Germany and France perform screening for HEV RNA in several blood establishments or plasma donations intended for use in high-risk patients respectively and, with Switzerland, are considering implementing selective or universal screening nationwide. In Greece, Portugal, Italy and Spain, the blood authorities are evaluating the situation. Denmark decided not to implement the HEV screening of blood donations. PMID:28449730

  9. Hepatitis E and blood donation safety in selected European countries: a shift to screening?

    PubMed

    Domanović, Dragoslav; Tedder, Richard; Blümel, Johannes; Zaaijer, Hans; Gallian, Pierre; Niederhauser, Christoph; Sauleda Oliveras, Silvia; O'Riordan, Joan; Boland, Fiona; Harritshøj, Lene; Nascimento, Maria São José; Ciccaglione, Anna Rita; Politis, Constatina; Adlhoch, Cornelia; Flan, Benoit; Oualikene-Gonin, Wahiba; Rautmann, Guy; Strengers, Paul; Hewitt, Patricia

    2017-04-20

    The public health implications of hepatitis E virus (HEV) in Europe have changed due to increasing numbers of hepatitis E cases and recent reports of chronic, persistent HEV infections associated with progression to cirrhosis in immunosuppressed patients. The main infectious risk for such immunosuppressed patients is exposure to undercooked infected pork products and blood transfusion. We summarised the epidemiology of HEV infections among blood donors and also outlined any strategies to prevent transfusion-transmitted HEV, in 11 European countries. In response to the threat posed by HEV and related public and political concerns, most of the observed countries determined seroprevalence of HEV in donors and presence of HEV RNA in blood donations. France, Germany, Spain and the United Kingdom (UK) reported cases of transfusion-transmitted HEV. Ireland and the UK have already implemented HEV RNA screening of blood donations; the Netherlands will start in 2017. Germany and France perform screening for HEV RNA in several blood establishments or plasma donations intended for use in high-risk patients respectively and, with Switzerland, are considering implementing selective or universal screening nationwide. In Greece, Portugal, Italy and Spain, the blood authorities are evaluating the situation. Denmark decided not to implement the HEV screening of blood donations. This article is copyright of The Authors, 2017.

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

    PubMed

    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.

  11. 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

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

    PubMed

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

    2017-02-23

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

  13. 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.

  14. 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.

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

    PubMed

    Porcella, Aleta; Walker, Kristy

    2005-01-01

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

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

    PubMed Central

    Siedle-Khan, Bob; Custer, Brian

    2015-01-01

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

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

    PubMed

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

    2017-02-01

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

  18. 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... Health. The Committee advises on a range of policy issues to include: (1) Definition of public health... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND...

  19. Technical note: preventive maintenance quality assurance.

    PubMed

    Russell, D

    1992-01-01

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

  20. 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).

  1. Software quality assurance handbook

    SciTech Connect

    Not Available

    1990-09-01

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

  2. Evaluation of the safety of Rh immunoglobulin by monitoring viral markers among Rh-negative female blood donors.

    PubMed

    Watanabe, K K; Busch, M P; Schreiber, G B; Zuck, T F

    2000-01-01

    Although immunoglobulin (Ig) preparations including RhIg have been noted for their record of safety, recent reports of hepatitis C virus (HCV) transmission by some Ig preparations have raised concern. This analysis examined the safety of RhIg manufactured in the US by comparing the prevalence and incidence of viral markers in Rh-negative and Rh-positive female blood donors. Demographic and viral marker data were analyzed for allogeneic donations collected from female donors of childbearing age (17-49 years of age) from April 1992 to May 1996. Prevalence and incidence rates were calculated for HCV, human immunodeficiency virus (HIV), and hepatitis B surface antigen (HBsAg). Of the 624,939 female donors included in the study, 96,355 (15.4%) were Rh-negative and 528,584 (84.6%) Rh-positive. There were no significant differences in the prevalence of HCV and HIV between Rh-negative and Rh-positive female donors. HBsAg prevalence was significantly higher among non-white compared to white donors. Following implementation of the more sensitive EIA 2.0 screening test for HCV in April 1992, prevalence and incidence rates declined over time at similar rates for Rh-negative and Rh-positive female donors. Rh-negative female donors had similar prevalence and incidence rates for most viral markers compared to Rh-positive female donors. This analysis supports the historical safety of RhIg.

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

    PubMed

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

    1997-01-01

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

  4. 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.

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-08

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

  8. Paracetamol effectiveness, safety and blood level monitoring during patent ductus arteriosus closure: a case series.

    PubMed

    Kessel, Irena; Waisman, Dan; Lavie-Nevo, Karen; Golzman, Marcelo; Lorber, Avraham; Rotschild, Avi

    2014-11-01

    Paracetamol was reported to be effective for patent ductus arteriosus (PDA) closure. We present a case series of PDA closure by paracetamol in seven premature infants. During the treatment, paracetamol blood levels did not exceed the recommended levels for analgesia and hyperthermia in six tested infants. None of the patients demonstrated significant disturbances of liver function.

  9. EMC Compliance Assurance Monitoring

    EPA Pesticide Factsheets

    The Compliance Assurance Monitoring, or CAM, rule is designed to satisfy the requirements for monitoring and compliance certification in the Part 70 operating permits program and Title VII of the 1990 Clean Air Act Amendments

  10. Quality Assurance Through Reimbursement

    PubMed Central

    Shaughnessy, Peter W.; Kurowski, Bettina

    1982-01-01

    Quality assurance and reimbursement programs normally function separately in the health care field. This paper reviews objectives and certain conceptual issues associated with each type of program. Its primary intent is to summarize substantive and operational topics which must be addressed if quality of care is to be enhanced through reimbursement. The focus is on methods for integrating quality assurance and reimbursement. The final section presents topics for future research. PMID:6807939

  11. RAVEN Quality Assurance Activities

    SciTech Connect

    Cogliati, Joshua Joseph

    2015-09-01

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

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

    NASA Technical Reports Server (NTRS)

    Canfield, Amy

    2016-01-01

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

  13. Performance assurance program plan

    SciTech Connect

    Rogers, B.H.

    1997-11-06

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

  14. RTOG quality assurance guidelines for interstitial hyperthermia.

    PubMed

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

    1991-05-01

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

  15. Ensuring the Safety of Your Endoscopic Procedure

    MedlinePlus

    ... the design of endoscopes to ensure patient safety. Quality Assurance and Training Any facility in which gastrointestinal endoscopy is performed must have an effective quality assurance program in place to ensure that endoscopes ...

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

    PubMed

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

    2016-02-01

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

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

    DTIC Science & Technology

    2012-11-01

    use up to 42 days. During this period, a known storage lesion occurs resulting in increased complications and death. We have previously shown that...profile with respect to the storage lesion compared to SLRBCs. Fifty-seven stable trauma patients who required one or two units of blood were...conclusion, CDRBCs have superior characteristics with respect to the storage lesion compared to SLRBCs. Increases in 2,3 DPG are consistent with our

  18. Femoral catheters: safety and efficacy in peripheral blood stem cell collection.

    PubMed

    Adorno, G; Zinno, F; Bruno, A; Lanti, A; Ballatore, G; Masi, M; Cudillo, L; Del Poeta, G; Riccitelli, A; Del Principe, M I; Pepe, R; Marchitelli, E; Morosetti, M; Meloni, C; Isacchi, G; Amadori, S

    1999-10-01

    Central venous access is necessary in patients candidate for peripheral blood stem cell (PBSC) collection. We report our experience with a dual lumen femoral catheter (Gamcath, 11 french), initially designed for hemodialysis. We studied 147 patients and performed 488 collections after mobilization with either G-CSF alone or chemotherapy + G-CSF, when the white blood cell count exceeded 1 x 10(9)/L, or when a measurable population of CD34+ cells (20/microL) was detected in peripheral blood. All patients received systemic anticoagulation with a low weight heparin and ultrasound examination was performed after the removal of the catheter. Seven patients developed thrombosis (4.7%), ten experienced hematomas at the site of catheter placement (6.8%) despite prophylactic platelet transfusions, while only one patient (0.6%) had a catheter-related infection. In conclusion, the short-term use of large bore femoral catheters in setting up PBSC collection seems to be associated with minimal risk of infection and low thrombotic incidence.

  19. Characterisation of occupational blood and body fluid exposures beyond the Needlestick Safety and Prevention Act

    PubMed Central

    Green-McKenzie, Judith; McCarthy, Ronda B; Shofer, Frances S

    2016-01-01

    Objective: To describe the use of mandated safety engineered sharps devices (SESDs) and personal protective equipment in healthcare workers (HCWs) with occupational body fluid exposures (BFE) since the Needlestick Safety and Prevention Act. Methods: Two questionnaires were administered, over 3 years, to HCWs who reported sharps or splash BFEs. Descriptive statistics and chi-square analysis were used. Results: Of the 498 questionnaires completed, nurses completed 262 (53%), house staff 155 (32 %), technicians 63 (13%) and phlebotomists 11 (2%). Four (1%) completers reported ‘other’ and three (1%) reported unknown. Sharps injuries accounted for 349 (70%) of the BFEs. SESDs were utilised 43% (128/299) of the time with a 54% (70/130) activation rate. Phlebotomists (80%; 8/10) and nurses (59%; 79/267) used SESDs more than doctors (27%; 31/86) and technicians (26%; 10/39) (P <0.0001). Fifty-four percent (185/207) of HCWs reported having had training on SESD use; nurses (64%; 98/154) and phlebotomists (70%; 7/8) significantly more so than house staff (44%; 59/133) and technicians (44%; 21/48) (P <0.05). Most splash BFEs were to the eyes 73% (91/149). Five percent (4/79) of HCWs used protective eyewear. Conclusions: Systematic regular training, appropriate protocols and iteratively providing the safest SESDs based on HCW experience and technological advances will further reduce the physical and emotional toll of BFEs.

  20. Management of arterial lines and blood sampling in intensive care: a threat to patient safety.

    PubMed

    Leslie, R A; Gouldson, S; Habib, N; Harris, N; Murray, H; Wells, V; Cook, T M

    2013-11-01

    In 2008, the UK National Patient Safety Agency (NPSA) made recommendations for safe arterial line management. Following a patient safety incident in our intensive care unit (ICU), we surveyed current practice in arterial line management and determined whether these recommendations had been adopted. We contacted all 241 adult ICUs in the UK; 228 (94.6%) completed the survey. Some NPSA recommendations have been widely implemented - use of sodium chloride 0.9% as flush fluid, two-person checking of fluids before use - and their practice was consistent. Others have been incompletely implemented and many areas of practice (prescription of fluids, two-person checking at shift changes, use of opaque pressure bags, arterial sampling technique) were highly variable. More importantly, the use of the wrong fluid as an arterial flush was reported by 30% of respondents for ICU practice, and a further 30% for practice elsewhere in the hospital. Our survey provides evidence of continuing risk to patients. © 2013 The Association of Anaesthetists of Great Britain and Ireland.

  1. Blood

    MedlinePlus

    ... spans vary from a few days to months. New cells are constantly being formed in the bone marrow. ... the bloodstream and are constantly being replaced by new cells. Blood also contains important proteins called clotting factors , ...

  2. Quality Assurance: Patient Chart Reviews

    NASA Astrophysics Data System (ADS)

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

    2009-07-01

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

  3. Quality Assurance: Patient Chart Reviews

    SciTech Connect

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

    2009-07-06

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

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

    PubMed

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

    2011-12-01

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

  5. [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.

  6. Crew safety. [in spaceflight

    NASA Technical Reports Server (NTRS)

    Slayton, D. K.

    1976-01-01

    Crew safety in the manned spaceflight is usually associated with a small group for safety and quality assurance. Crew safety is actually an integral part of all program phases from conception through final implementation. Factors associated with improving safety at each phase of development are discussed. Topics discussed include design, manufacture, hardware/software checkout, management reviews, training and simulation, and data retrieval and analysis. Crew safety is best accomplished by flying a successful mission.

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

    PubMed

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

    2014-03-01

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

  8. Assessment of drug-induced increases in blood pressure during drug development: report from the Cardiac Safety Research Consortium.

    PubMed

    Sager, Philip; Heilbraun, Jeffrey; Turner, J Rick; Gintant, Gary; Geiger, Mary J; Kowey, Peter R; Mansoor, George A; Mendzelevski, Boaz; Michelson, Eric L; Stockbridge, Norman; Weber, Michael A; White, William B

    2013-04-01

    This White Paper, prepared by members of the Cardiac Safety Research Consortium, discusses several important issues regarding the evaluation of blood pressure (BP) responses to drugs being developed for indications not of a direct cardiovascular (CV) nature. A wide range of drugs are associated with off-target BP increases, and both scientific attention and regulatory attention to this topic are increasing. The article provides a detailed summary of scientific discussions at a Cardiac Safety Research Consortium-sponsored Think Tank held on July 18, 2012, with the intention of moving toward consensus on how to most informatively collect and analyze BP data throughout clinical drug development to prospectively identify unacceptable CV risk and evaluate the benefit-risk relationship. The overall focus in on non-CV drugs, although many of the points also pertain to CV drugs. Brief consideration of how clinical assessment can be informed by nonclinical investigation is also outlined. These discussions present current thinking and suggestions for furthering our knowledge and understanding of off-target drug-induced BP increases and do not represent regulatory guidance. Copyright © 2013 Mosby, Inc. All rights reserved.

  9. 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

  10. 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

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

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  12. 49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  13. 49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  14. 49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  15. 49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

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

    PubMed Central

    Robati, R; Mirahmadi Nejad, E

    2015-01-01

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

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

    PubMed

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

    2017-02-01

    A collaboration that grew over time between local hemovigilance stakeholders and the Massachusetts Department of Public Health (MDPH) resulted in the change from a paper-based method of reporting adverse reactions and monthly transfusion activity for regulatory compliance purposes to statewide adoption of electronic reporting via the National Healthcare Safety Network (NHSN). The NHSN is a web-based surveillance system that offers the capacity to capture transfusion-related adverse events, incidents, and monthly transfusion statistics from participating facilities. Massachusetts' hospital blood banks share the data they enter into NHSN with the MDPH to satisfy reporting requirements. Users of the NHSN Hemovigilance Module adhere to specified data entry guidelines, resulting in data that are comparable and standardized. Keys to successful statewide adoption of this reporting method include the fostering of strong partnerships with local hemovigilance champions and experts, engagement of regulatory and epidemiology divisions at the state health department, the leveraging of existing relationships with hospital NHSN administrators, and the existence of a regulatory deadline for implementation. Although limitations exist, successful implementation of statewide use of the NHSN Hemovigilance Module for hospital blood bank reporting is possible. The result is standardized, actionable data at both the hospital and state level that can facilitate interfacility comparisons, benchmarking, and opportunities for practice improvement. © 2016 AABB.

  18. Integrated Environment for Development and Assurance

    DTIC Science & Technology

    2015-01-26

    2015 © 2015 Carnegie Mellon University The Symptom: Missed Stepper Motor Steps Stepper motor (SM) controls a valve • Commanded to achieve a specified...new desired position Safety hazard due to software design • Execution time variation results in missed steps • Leads to misaligned stepper motor ...Weight, Electrical , Fuel, Hydraulics,… 14 Integrated Development and Assurance Feiler, Jan 26, 2015 © 2015 Carnegie Mellon University Rapid Architecture

  19. Safety of the blood supply. Surrogate testing and transmission of hepatitis C in patients after massive transfusion.

    PubMed

    Morris, J A; Wilcox, T R; Reed, G W; Hunter, E B; Wallas, C H; Steane, E A; Shotts, S D; Vitsky, J L

    1994-05-01

    To define a risk profile for post-transfusion hepatitis C in patients receiving massive transfusion. Hepatitis C accounts for more than 90% of post-transfusion hepatitis. Two-hundred twenty-one of 8,765 consecutive trauma admissions to a Level I trauma center received more than 20 units of erythrocytes. Sixty-nine survivors had positive viral serologic tests at least 1 year after transfusion. Surrogate testing for hepatitis C using alanine aminotransferase (ALT) levels and antibodies to hepatitis B core antigen (Core) began in October 1986 and January 1987, respectively. Donor blood for group 1 (pre-ALT/Core) was transfused before surrogate screening was introduced. Donor blood for group 2 (post-ALT/Core) was transfused after surrogate screening. Sixty-nine patients received blood products from 4,987 donors (mean, 72.3 units of exposure). No patient tested positive for antibodies to hepatitis B surface antigen, human immunodeficiency virus, or human T-lymphotrophic virus type 1. However 23.2% tested positive for hepatitis C virus (HCV) as measured by a second-generation enzyme immunoassay (HCV 2.0) and a recombinant immunoblot assay (RIBA), and 21.7% tested positive by HCV 1.0. Antibodies to Core were found in 8.7% of patients. The risk for post-transfusion hepatitis C per unit of exposure is estimated to be 1.52% group 1 (pre-ALT/Core) and 0.239% for group 2 (post-ALT/Core). The introduction of ALT/Core donor screening by a blood bank reduced the incidence of post-transfusion hepatitis C by 84%. The risk for post-transfusion hepatitis C depends on units of exposure, screening techniques, and prevalence of hepatitis C in the donor population. In our community, the risk for post-transfusion hepatitis C is less than 0.2% per unit of exposure. The population of massively transfused patients may serve as our effective resource for monitoring the safety of the blood supply.

  20. Safety of the blood supply. Surrogate testing and transmission of hepatitis C in patients after massive transfusion.

    PubMed Central

    Morris, J A; Wilcox, T R; Reed, G W; Hunter, E B; Wallas, C H; Steane, E A; Shotts, S D; Vitsky, J L

    1994-01-01

    OBJECTIVE: To define a risk profile for post-transfusion hepatitis C in patients receiving massive transfusion. SUMMARY BACKGROUND DATA: Hepatitis C accounts for more than 90% of post-transfusion hepatitis. METHODS: Two-hundred twenty-one of 8,765 consecutive trauma admissions to a Level I trauma center received more than 20 units of erythrocytes. Sixty-nine survivors had positive viral serologic tests at least 1 year after transfusion. Surrogate testing for hepatitis C using alanine aminotransferase (ALT) levels and antibodies to hepatitis B core antigen (Core) began in October 1986 and January 1987, respectively. Donor blood for group 1 (pre-ALT/Core) was transfused before surrogate screening was introduced. Donor blood for group 2 (post-ALT/Core) was transfused after surrogate screening. RESULTS: Sixty-nine patients received blood products from 4,987 donors (mean, 72.3 units of exposure). No patient tested positive for antibodies to hepatitis B surface antigen, human immunodeficiency virus, or human T-lymphotrophic virus type 1. However 23.2% tested positive for hepatitis C virus (HCV) as measured by a second-generation enzyme immunoassay (HCV 2.0) and a recombinant immunoblot assay (RIBA), and 21.7% tested positive by HCV 1.0. Antibodies to Core were found in 8.7% of patients. The risk for post-transfusion hepatitis C per unit of exposure is estimated to be 1.52% group 1 (pre-ALT/Core) and 0.239% for group 2 (post-ALT/Core). CONCLUSIONS: The introduction of ALT/Core donor screening by a blood bank reduced the incidence of post-transfusion hepatitis C by 84%. The risk for post-transfusion hepatitis C depends on units of exposure, screening techniques, and prevalence of hepatitis C in the donor population. In our community, the risk for post-transfusion hepatitis C is less than 0.2% per unit of exposure. The population of massively transfused patients may serve as our effective resource for monitoring the safety of the blood supply. PMID:7514394

  1. Blood Pressure Lowering and Safety Improvements With Liver Angiotensinogen Inhibition in Models of Hypertension and Kidney Injury.

    PubMed

    Mullick, Adam E; Yeh, Steve T; Graham, Mark J; Engelhardt, Jeffery A; Prakash, Thazha P; Crooke, Rosanne M

    2017-09-01

    Uncontrolled hypertension is an important contributor to cardiovascular disease. Despite the armamentarium of antihypertensive treatments, there remains a need for novel agents effective in individuals who cannot reach acceptable blood pressure levels. Inhibitors targeting the renin-angiotensin-aldosterone system (RAAS) are widely used but may not optimally inhibit RAAS and demonstrate an acceptable safety profile. Experiments were conducted to characterize a series of AGT (angiotensinogen) antisense oligonucleotides (ASOs) and compare their efficacy and tolerability to traditional RAAS blockade. AGT ASOs which target multiple systemic sites of AGT versus an N-acetylgalactosamine-conjugated AGT ASO that targets the liver were compared with captopril and losartan. Spontaneously hypertensive rats fed an 8% NaCl diet, a model of malignant hypertension resistant to standard RAAS inhibitors, demonstrated robust and durable blood pressure reductions with AGT ASO treatments, which was not observed with standard RAAS blockade. Studies in rat models of acute kidney injury produced by salt deprivation revealed kidney injury with ASO treatment that reduced kidney-expressed AGT, but not in animals treated with the N-acetylgalactosamine AGT ASO despite comparable plasma AGT reductions. Administration of either captopril or losartan also produced acute kidney injury during salt deprivation. Thus, intrarenal RAAS derived from kidney AGT, and inhibited by the standard of care, contributes to the maintenance of renal function during severe RAAS challenge. Such improvements in efficacy and tolerability by a liver-selective AGT inhibitor could be desirable in individuals not at their blood pressure goal with existing RAAS blockade. © 2017 American Heart Association, Inc.

  2. Just in Time Assurance

    DTIC Science & Technology

    2010-04-01

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

  3. Safety of Frequent Venous Blood Sampling in a Pediatric Research Population

    PubMed Central

    Broder-Fingert, Sarabeth; Crowley, William F.; Boepple, Paul A.

    2009-01-01

    Objective To monitor hematological indices in otherwise normal children with central precocious puberty (CPP) who underwent frequent venous sampling as part of a longitudinal clinical research study. Study design 34 female subjects underwent frequent venous sampling (q10-20 min for 8-16 hrs) every 6 months for ≥ 3 years during and after their treatment with a GnRH analogue. Hgb, MCV and ferritin were measured prior to and following each phlebotomy session. Results At baseline, average Hgb was 12.5 ± 0.7 g/l. At conclusion of the first sampling session, Hgb fell 1.2 ± 0.1 g/l, remaining within the normal range for age. Upon 3-month follow-up, there was complete recovery of Hgb (12.6 ± 0.2 g/l). Longitudinal evaluation every 6-months for up to 3-years showed no significant differences in Hgb, MCV or ferritin levels from baseline. No clinically significant adverse effects attributable to phlebotomy were reported. Discussion When appropriate safety guidelines were followed, both acute and long-term frequent venous sampling in a pediatric population was safe. Guidelines include monitoring of hematological indices, phlebotomy volume <10cc/kg/24 hours, and iron replacement. PMID:19026428

  4. Defining Baconian Probability for Use in Assurance Argumentation

    NASA Technical Reports Server (NTRS)

    Graydon, Patrick J.

    2016-01-01

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

  5. AVLIS Production Plant Preliminary Quality Assurance Plan and Assessment

    SciTech Connect

    Not Available

    1984-11-15

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

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

    NASA Technical Reports Server (NTRS)

    Graydon, Patrick J.

    2015-01-01

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

  7. The limits of sterility assurance

    PubMed Central

    von Woedtke, Thomas; Kramer, Axel

    2008-01-01

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

  8. The limits of sterility assurance.

    PubMed

    von Woedtke, Thomas; Kramer, Axel

    2008-09-03

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

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

    PubMed

    Dowling, Claire; Patel, Seraphim Jr

    2014-11-27

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

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

    PubMed

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

    2016-02-01

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

  11. Quality Assurance for All

    ERIC Educational Resources Information Center

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

    2010-01-01

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

  12. Quality Assurance for All

    ERIC Educational Resources Information Center

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

    2010-01-01

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

  13. UST Financial Assurance Information

    EPA Pesticide Factsheets

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

  14. Benchmarking Software Assurance Implementation

    DTIC Science & Technology

    2011-05-18

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

  15. Read Code Quality Assurance

    PubMed Central

    Schulz, Erich; Barrett, James W.; Price, Colin

    1998-01-01

    As controlled clinical vocabularies assume an increasing role in modern clinical information systems, so the issue of their quality demands greater attention. In order to meet the resulting stringent criteria for completeness and correctness, a quality assurance system comprising a database of more than 500 rules is being developed and applied to the Read Thesaurus. The authors discuss the requirement to apply quality assurance processes to their dynamic editing database in order to ensure the quality of exported products. Sources of errors include human, hardware, and software factors as well as new rules and transactions. The overall quality strategy includes prevention, detection, and correction of errors. The quality assurance process encompasses simple data specification, internal consistency, inspection procedures and, eventually, field testing. The quality assurance system is driven by a small number of tables and UNIX scripts, with “business rules” declared explicitly as Structured Query Language (SQL) statements. Concurrent authorship, client-server technology, and an initial failure to implement robust transaction control have all provided valuable lessons. The feedback loop for error management needs to be short. PMID:9670131

  16. Survey of Software Assurance Techniques for Highly Reliable Systems

    NASA Technical Reports Server (NTRS)

    Nelson, Stacy

    2004-01-01

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

  17. Efficiency and safety of varying the frequency of whole blood donation (INTERVAL): a randomised trial of 45 000 donors.

    PubMed

    Di Angelantonio, Emanuele; Thompson, Simon G; Kaptoge, Stephen; Moore, Carmel; Walker, Matthew; Armitage, Jane; Ouwehand, Willem H; Roberts, David J; Danesh, John

    2017-09-20

    Limits on the frequency of whole blood donation exist primarily to safeguard donor health. However, there is substantial variation across blood services in the maximum frequency of donations allowed. We compared standard practice in the UK with shorter inter-donation intervals used in other countries. In this parallel group, pragmatic, randomised trial, we recruited whole blood donors aged 18 years or older from 25 centres across England, UK. By use of a computer-based algorithm, men were randomly assigned (1:1:1) to 12-week (standard) versus 10-week versus 8-week inter-donation intervals, and women were randomly assigned (1:1:1) to 16-week (standard) versus 14-week versus 12-week intervals. Participants were not masked to their allocated intervention group. The primary outcome was the number of donations over 2 years. Secondary outcomes related to safety were quality of life, symptoms potentially related to donation, physical activity, cognitive function, haemoglobin and ferritin concentrations, and deferrals because of low haemoglobin. This trial is registered with ISRCTN, number ISRCTN24760606, and is ongoing but no longer recruiting participants. 45 263 whole blood donors (22 466 men, 22 797 women) were recruited between June 11, 2012, and June 15, 2014. Data were analysed for 45 042 (99·5%) participants. Men were randomly assigned to the 12-week (n=7452) versus 10-week (n=7449) versus 8-week (n=7456) groups; and women to the 16-week (n=7550) versus 14-week (n=7567) versus 12-week (n=7568) groups. In men, compared with the 12-week group, the mean amount of blood collected per donor over 2 years increased by 1·69 units (95% CI 1·59-1·80; approximately 795 mL) in the 8-week group and by 0·79 units (0·69-0·88; approximately 370 mL) in the 10-week group (p<0·0001 for both). In women, compared with the 16-week group, it increased by 0·84 units (95% CI 0·76-0·91; approximately 395 mL) in the 12-week group and by 0·46 units (0·39-0·53

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

    NASA Technical Reports Server (NTRS)

    Klein, W. E.

    1980-01-01

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

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

    NASA Technical Reports Server (NTRS)

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

    1981-01-01

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

  20. Animal Drug Safety FAQs

    MedlinePlus

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Animal & Veterinary Home Animal & Veterinary Safety & Health Frequently Asked Questions Animal Drug Safety Frequently Asked Questions Share Tweet Linkedin ...

  1. 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

  2. Quality assurance program plan for radionuclide airborne emissions monitoring

    SciTech Connect

    Boom, R.J.

    1995-03-01

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

  3. The safety of early fresh, whole blood transfusion among severely battle injured at US Marine Corps forward surgical care facilities in Afghanistan.

    PubMed

    Auten, Jonathan D; Lunceford, Nicole L; Horton, Jaime L; Galarneau, Mike R; Galindo, Roger M; Shepps, Craig D; Zieber, Tara J; Dewing, Chris B

    2015-11-01

    In Afghanistan, care of the acutely injured trauma patient commonly occurred in facilities with limited blood banking capabilities. Apheresis platelets were often not available. Component therapy consisted of 1:1 packed red blood cells and fresh frozen plasma. Fresh, whole blood transfusion often augmented therapy in the severely injured patient. This study analyzed the safety of fresh, whole blood use in a resource-limited setting. A retrospective analysis was performed on a prospectively collected data set of US battle injuries presenting to three US Marine Corps (USMC) expeditionary surgical care facilities in Helmand Province, Afghanistan, between January 2010 and July 2012. Included in the review were patients with Injury Severity Scores (ISSs) of 15 or higher receiving blood transfusions. Univariate analyses were performed, followed by multivariable logistic regression to describe the relationship between the treatment group and posttreatment complications such as trauma-induced coagulopathy, infection, mortality, venous thromboembolism, and transfusion reaction. Propensity scores were calculated and included in multivariable models to adjust for potential bias in treatment selection. A total of 61 patients were identified; all were male marines with a mean (SD) age of 23.5 (3.6) years. The group receiving fresh, whole blood was noted to have higher ISSs and lower blood pressure, pH, and base deficits on arrival. Traumatic coagulopathy was significantly less common in the group receiving fresh, whole blood (odds ratio, 0.01; 95% confidence interval, 0.00-0.18). Multivariable models found no other significant differences between the treatment groups. The early use of fresh, whole blood in a resource-limited setting seems to confer a benefit in reducing traumatic coagulopathy. This study's small sample size precludes further statement on the overall safety of fresh, whole blood use. Therapy study, level IV.

  4. Efficacy and safety of olmesartan medoxomil in patients with stage 1 hypertension: blood pressure lowering and goal achievement.

    PubMed

    Wilford Germino, F

    2010-11-01

    Hypertension is a known risk factor for cardiovascular events and mortality. The risk of cardiovascular events increases with age and is linear above 115/75 mm Hg. It also doubles for every 20/10-mm Hg elevation beyond this level and at every age level. Although guidelines vary somewhat by country, the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure recommends a blood pressure (BP) goal of < 140/90 mm Hg for patients with uncomplicated hypertension and < 130/80 mm Hg for patients with type 2 diabetes mellitus (T2DM) or renal disease. Based on clinical evidence, patients with stage 1 hypertension (seated cuff systolic BP of 140-159 mm Hg or diastolic BP of 90-99 mm Hg) should be treated to targeted BP levels to reduce cardiovascular morbidity and mortality. The angiotensin II receptor blockers (ARBs) are well tolerated and demonstrate significant BP reduction. Olmesartan medoxomil (OM), an ARB, has been well studied and achieves significant BP lowering and goal achievement with good tolerability. Moreover, combination therapy comprising OM plus hydrochlorothiazide can significantly increase BP goal achievement without significantly increasing adverse events. This review evaluates clinical efficacy and safety data from 5 OM-based studies: 4 dose-titration studies and 1 factorial study. Study results demonstrate that OM ± hydrochlorothiazide is highly effective in reducing BP while enabling a majority of patients with stage 1 hypertension to achieve BP goal. In addition, OM tolerability data showed that the high achievement of BP goals was not attained at the expense of increased adverse events. This treatment is associated with low discontinuation rates, even in elderly patients and individuals with T2DM. The clinical data presented in this review support OM-based therapy as a rational and safe therapeutic option for patients with stage 1 hypertension.

  5. Blood and body fluid exposure risks among health care workers: results from the Duke Health and Safety Surveillance System.

    PubMed

    Dement, John M; Epling, Carol; Ostbye, Truls; Pompeii, Lisa A; Hunt, Debra L

    2004-12-01

    Health care workers (HCWs) are at risk of exposures to human blood and body fluids (BBF). Needlestick injuries and splashes place HCWs at risk for numerous blood-borne infections including human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV). Utilizing a new comprehensive occupational health surveillance system, the objective of this research was to better define the BBF exposure risk and risk factors among employees of a large tertiary medical center. A population of 24,425 HCWs employed in jobs with potential BBF exposures was followed for BBF exposure events from 1998 to 2002. BBF exposure rates were calculated for strata defined by age, race, gender, occupation, work location, and duration of employment. Poisson regression was used for detailed analyses of risk factors for BBF exposure. The study population reported 2,730 BBF exposures during the study period, resulting in an overall annual rate of 5.5 events/100 FTEs and a rate of 3.9 for percutaneous exposures. Higher rates were observed for males, persons employed less than 4 years, Hispanic employees, and persons less than 45 years of age. Much higher rates were observed for house staff, nurse anesthetists, inpatient nurses, phlebotomists, and surgical/operating room technicians. Poisson regression results strengthened and extended results from stratified analyses. Rates of percutaneous exposures from hollow needles were found to decrease over the study period; however, exposure rates from suture needles appear to be increasing. While continued training efforts need to be directed toward new HCWs, our data also suggest that employees who have been in their job 1-4 years continue to be at higher risk of BBF exposures. This research also points to the need for better safety devices/products and work practices to reduce suture-related injuries.

  6. Quality Assurance for University Teaching.

    ERIC Educational Resources Information Center

    Ellis, Roger, Ed.

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

  7. Quality Assurance in Nursing Homes.

    ERIC Educational Resources Information Center

    Balgopal, Pallassana R.; And Others

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

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

    PubMed

    2015-05-22

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

  9. Argument-Based Airworthiness Assurance of Small UAS

    NASA Technical Reports Server (NTRS)

    Denney, Ewen; Pai, Ganesh

    2015-01-01

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

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

    PubMed

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

    2011-01-20

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

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

    PubMed Central

    2012-01-01

    Backgrounds We conducted a pilot study of the infusion of intravenous autologous cord blood (CB) in children with cerebral palsy (CP) to assess the safety and feasibility of the procedure as well as its potential efficacy in countering neurological impairment. Methods Patients diagnosed with CP were enrolled in this study if their parents had elected to bank their CB at birth. Cryopreserved CB units were thawed and infused intravenously over 10~20 minutes. We assessed potential efficacy over 6 months by brain magnetic resonance imaging (MRI)-diffusion tensor imaging (DTI), brain perfusion single-photon emission computed tomography (SPECT), and various evaluation tools for motor and cognitive functions. Results Twenty patients received autologous CB infusion and were evaluated. The types of CP were as follows: 11 quadriplegics, 6 hemiplegics, and 3 diplegics. Infusion was generally well-tolerated, although 5 patients experienced temporary nausea, hemoglobinuria, or urticaria during intravenous infusion. Diverse neurological domains improved in 5 patients (25%) as assessed with developmental evaluation tools as well as by fractional anisotropy values in brain MRI-DTI. The neurologic improvement occurred significantly in patients with diplegia or hemiplegia rather than quadriplegia. Conclusions Autologous CB infusion is safe and feasible, and has yielded potential benefits in children with CP. PMID:22443810

  12. Safety of Allogeneic Umbilical Cord Blood Stem Cells Therapy in Patients with Severe Cerebral Palsy: A Retrospective Study.

    PubMed

    Feng, Mei; Lu, Aili; Gao, Hongxia; Qian, Caiwen; Zhang, Jun; Lin, Tongxiang; Zhao, Yuanqi

    2015-01-01

    This retrospective study aimed to assess the safety of patients with severe cerebral palsy (CP), who received allogeneic umbilical cord blood stem cells (UCBSCs) treatment from August 2009 to December 2012 in Guangdong Provincial Hospital of Chinese Medicine. A total of 47 patients with average age of 5.85 ± 6.12 years were evaluated in this study. There was no significant association with allogeneic UCBSCs treatments found in the data of the laboratory index . No casualties occurred. Some adverse events during treatments were found in 26 (55.3%) patients, including fever (42.6%) and vomiting (21.2%). Intrathecal infusion and the ages at the initiation of treatment (≤10 years old) were risk factors for the occurrence of adverse events by logistic regression analysis. However, all adverse events disappeared after symptomatic treatment. No treatment related serious adverse events were found in follow-up visits within 6 months. In conclusion, allogeneic UCBSCs treatment was relatively safe for severe CP patients.

  13. Repeated autologous umbilical cord blood infusions are feasible and had no acute safety issues in young babies with congenital hydrocephalus.

    PubMed

    Sun, Jessica M; Grant, Gerald A; McLaughlin, Colleen; Allison, June; Fitzgerald, Anne; Waters-Pick, Barbara; Kurtzberg, Joanne

    2015-12-01

    Babies with congenital hydrocephalus often experience developmental disabilities due to brain injury associated with prolonged increased pressure on the developing brain parenchyma. Umbilical cord blood (CB) infusion has favorable effects in animal models of brain hypoxia and stroke and is being investigated in clinical trials of brain injury in both children and adults. We sought to establish the safety and feasibility of repeated intravenous infusions of autologous CB in young babies with congenital hydrocephalus. Infants with severe congenital hydrocephalus and an available qualified autologous CB unit traveled to Duke for evaluation and CB infusion. When possible, the CB unit was utilized for multiple infusions. Patient and CB data were obtained at the time of infusion and analyzed retrospectively. From October 2006 to August 2014, 76 patients with congenital hydrocephalus received 143 autologous CB infusions. Most babies received repeated doses, for a total of two (n = 45), three (n = 18), or four (n = 4) infusions. There were no infusion-related adverse events. As expected, all babies experienced developmental delays. Cryopreserved CB products may be effectively manipulated to provide multiple CB doses. Repeated intravenous infusion of autologous CB is safe and feasible in young babies with congenital hydrocephalus.

  14. [Medical quality assurance today].

    PubMed

    Schäfer, Robert D

    2008-01-01

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

  15. High Assurance Software

    DTIC Science & Technology

    2013-10-22

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

  16. Software Quality Assurance Metrics

    NASA Technical Reports Server (NTRS)

    McRae, Kalindra A.

    2004-01-01

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

  17. Software Quality Assurance Metrics

    NASA Technical Reports Server (NTRS)

    McRae, Kalindra A.

    2004-01-01

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

  18. Assuring Software Reliability

    DTIC Science & Technology

    2014-08-01

    consider interactions between software and non -computer hardware. There may be an implicit assumption that software quality is always improving as once a...Justification An assurance case provides a more effective way to convey the engineering information in this report to both experts and non -experts. In...experts and non - experts. CMU/SEI-2014-SR-008 | 13 3 Causal Analysis of Software Failures The DoD RAM Guide recommendation for better

  19. Foundations for Software Assurance

    DTIC Science & Technology

    2013-12-01

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

  20. Specified assurance level sampling procedure

    SciTech Connect

    Willner, O.

    1980-11-01

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

  1. Safety and efficacy of preoperative autologous blood donation for high-risk pregnant women: experience of a large university hospital in Japan.

    PubMed

    Yamamoto, Yasuhiro; Yamashita, Takahiro; Tsuno, Nelson Hirokazu; Nagamatsu, Takeshi; Okochi, Naoko; Hyodo, Hironobu; Ikeda, Toshiyuki; Kawabata, Michiru; Kamei, Yoshimasa; Nagura, Yutaka; Sone, Shinji; Fujii, Tomoyuki; Takahashi, Koki; Kozuma, Shiro

    2014-05-01

    Preoperative autologous blood donation (PAD) has the advantages over allogeneic blood transfusion of theoretically no risk of viral infection and alloimmunization. However, there are some concerns regarding PAD in pregnant women, as they sometimes become anemic and adverse effects such as low blood pressure could be harmful to fetuses. In our hospital, the PAD program was implemented in 2006 and has been used in pregnant women at high risk of massive hemorrhage. In this study, the safety of PAD in pregnant women and its efficacy for avoiding allogeneic blood transfusion were investigated. The hospital records of pregnant women who delivered at our hospital from January 2009 to June 2012 were reviewed and those who were enrolled in the PAD program for predicted massive hemorrhage were analyzed. Among the total of 3095 deliveries, 69 cases enrolled in the PAD program were analyzed. Blood donation was performed 189 times for the 69 cases. The median donated blood volume was 1200 mL (range, 400-2000). The mean blood loss during delivery was 1976 ± 1654 mL. Autologous blood was transfused in 64 cases. Allogeneic blood transfusion was required in five cases of massive blood loss exceeding 5000 mL. In the other 64 cases, no additional allogeneic blood transfusion was required. No adverse events were observed in either the pregnant women or fetuses. For pregnant women at a high risk of massive hemorrhage, our PAD program was safe and effective for avoiding allogeneic blood transfusion. © 2014 The Authors. Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology.

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

    PubMed

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

    1994-01-01

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

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

    SciTech Connect

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

    1993-03-01

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

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

    NASA Astrophysics Data System (ADS)

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

    1993-03-01

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

  5. Human Spaceflight Safety Hearing

    NASA Image and Video Library

    2009-12-02

    Bryan O'Connor, Chief of Safety and Mission Assurance at NASA, testifies before a hearing before the House Subcommitte on Space and Aeronautics regarding Safety of Human Spaceflight on Capitol Hill, Wednesday, Dec. 2, 2009, in Washington. Photo Credit: (NASA/Bill Ingalls)

  6. Human Spaceflight Safety Hearing

    NASA Image and Video Library

    2009-12-02

    Bryan O'Connor, Chief of Safety and Mission Assurance at NASA, testifies during a hearing before the House Subcommitte on Space and Aeronautics regarding Safety of Human Spaceflight on Capitol Hill, Wednesday, Dec. 2, 2009, in Washington. Photo Credit: (NASA/Bill Ingalls)

  7. Understanding and Evaluating Assurance Cases

    NASA Technical Reports Server (NTRS)

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

    2015-01-01

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

  8. Glycemic profile and effectiveness and safety of insulin therapy in septic patients: is the blood glucose level sufficient?

    PubMed

    Szrama, Jakub; Smuszkiewicz, Piotr; Trojanowska, Iwona

    2009-10-01

    Hyperglycemia in sepsis is managed by intensive insulin therapy, which can cause hypoglycemia. The aim of the study was to evaluate the glycemic profile as well as safety and effectiveness of a nurse-controlled insulin therapy protocol in patients with severe sepsis and septic shock. The study included 16 septic patients who died (nonsurvivors) and 61 septic patients who survived. Glycemia was measured every 4 h, and the dose of insulin infusion was adjusted to maintain glycemia of 4.4 mmol/l to 8.3 mmol/l. We analyzed glycemia levels and daily variations, insulin dose, episodes of hypo- and hyperglycemia. Nonsurvivors and survivors had similar mean glycemia levels (7.38 vs. 7.08 mmol/l; p = 0.20) and insulin requirements (median [Me] = 26.9 vs. 23.9 units/d; p = 0.22; Me = 1.7 vs. 1.4 units/h; p = 0.25). Daily glycemia variation (Me = 4.81 vs. 3.03 mmol/l; p <0.001), episodes of hypoglycemia (18.8% vs. 3.3%; p = 0.02), spontaneous severe hypoglycemia (12.5% vs. 0%; p = 0.006) and hyperglycemia (75.0% vs. 45.9%; p = 0.04) were higher and more frequent in nonsurvivors. Three of 5393 blood samples (0.05%) met severe insulin-induced hypoglycemia criteria, and 74.4% of samples met the recommended range of 4.4-8.3 mmol/l. Patients who died experienced more episodes of hyperglycemia, spontaneous hypoglycemia and greater variation in the daily glycemia level. Daily glycemia variation is more reliable than a mean glycemic level in evaluating glucose homeostasis in septic patients. Few episodes of severe insulin-induced hypoglycemia occurred while using the nurse-controlled insulin therapy protocol.

  9. Advanced Software Quality Assurance

    DTIC Science & Technology

    1977-03-01

    ment Head, General Research Corporation reports are subject to Independent review by a staff member not connected with the project. This report...ö CR^-72,0 / y < BwKmTö^RoTi T^W^n TNÖ^RcTN^rTlON NAME AND ADDRESS General Research Corporation / P.O. Box 3587 / Santa Barbara, CA...Idrnlily tt* block numb«" This is a report of the work performed by General Research Corporation during the Advanced Software Quality Assurance contract

  10. West Nile virus nucleic acid persistence in whole blood months after clearance in plasma: implication for transfusion and transplantation safety

    PubMed Central

    Lanteri, Marion C.; Lee, Tzong-Hae; Wen, Li; Kaidarova, Zhanna; Bravo, Marjorie D.; Kiely, Nancy E.; Kamel, Hany T.; Tobler, Leslie H.; Norris, Philip J.; Busch, Michael P.

    2014-01-01

    BACKGROUND Previous reports of WNV RNA persistence in blood compartments have raised concerns around the remaining risk of WNV transfusion-transmission. This study characterized the dynamics of WNV viremia in blood compartments in a longitudinal cohort of 54 WNV-infected blood donors. STUDY DESIGN AND METHODS Blood samples were collected throughout the year after WNV RNA+ blood donation (index) and characterized for anti-WNV IgM and IgG antibodies and for WNV RNA by real-time reverse-transcription polymerase chain reaction. WNV viral loads were compared in plasma and whole blood samples and correlated with blood groups and clinical outcomes. RESULTS WNV RNA persisted in the red blood cell (RBC) compartment up to three months post-index in 42% of the donors. Donors with the highest WNV RNA levels in plasma at index maintained the highest WNV RNA levels in whole blood over the three months post-index. Blood group A donors maintained higher post-index WNV viral load in whole blood than blood group O individuals (P=0.027). Despite a trend for WNV RNA to persist longer in whole blood from symptomatic subjects, no significant association was found between WNV RNA levels in whole blood and disease outcome. CONCLUSION This study confirmed that WNV RNA persists in the RBC fraction in whole blood and further suggested that the level of persistence in whole blood may be a reflection of initial viral burden in plasma. The association with blood groups suggests that WNV adherence to RBCs may be mediated by molecules overrepresented at the surface of blood group A RBCs. PMID:24965017

  11. Quality assurance in film radiography

    SciTech Connect

    Van Bellegem, L.; Vaessen, B.

    1993-12-31

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

  12. Software Quality Assurance Audits Guidebooks

    NASA Technical Reports Server (NTRS)

    1990-01-01

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

  13. Assurance Limits for Vulnerable Area

    DTIC Science & Technology

    1975-08-01

    IN» At) Ml* 11(t RIA-80-U373 TECHNICAL LffiRARY AD* 0/4, "Wfr NWSC/CR/RDTR-10 ASSURANCE LIMITS FOR 5 0712 01001493 3 VULNERABLE AREA...ASSURANCE LIMITS FOR VULNERABLE AREA DATA ANALYSIS TECHNIQUES OF VULNERABILITY ASSESSMENTS PARTIAL FULFILLMENT OF FY 75 ASSESSMENT...RECIPIENT’S CATALOG NUMBER 4. TITLE (and Subtltla) ASSURANCE LIMITS FOR VULNERABLE AREA B. TYPE OF REPORT * PERIOD COVERED 1. AUTHORS

  14. Transplantation of autologous peripheral blood mononuclear cells in the subarachnoid space for amyotrophic lateral sclerosis: a safety analysis of 14 patients.

    PubMed

    Li, Xiao-Yan; Liang, Zhan-Hua; Han, Chao; Wei, Wen-Juan; Song, Chun-Li; Zhou, Li-Na; Liu, Yang; Li, Ying; Ji, Xiao-Fei; Liu, Jing

    2017-03-01

    There is a small amount of clinical data regarding the safety and feasibility of autologous peripheral blood mononuclear cell transplantation into the subarachnoid space for the treatment of amyotrophic lateral sclerosis. The objectives of this retrospective study were to assess the safety and efficacy of peripheral blood mononuclear cell transplantation in 14 amyotrophic lateral sclerosis patients to provide more objective data for future clinical trials. After stem cell mobilization and collection, autologous peripheral blood mononuclear cells (1 × 10(9)) were isolated and directly transplanted into the subarachnoid space of amyotrophic lateral sclerosis patients. The primary outcome measure was incidence of adverse events. Secondary outcome measures were electromyography 1 week before operation and 4 weeks after operation, Functional Independence Measurement, Berg Balance Scale, and Dysarthria Assessment Scale 1 week preoperatively and 1, 2, 4 and 12 weeks postoperatively. There was no immediate or delayed transplant-related cytotoxicity. The number of leukocytes, serum alanine aminotransferase and creatinine levels, and body temperature were within the normal ranges. Radiographic evaluation showed no serious transplant-related adverse events. Muscle strength grade, results of Functional Independence Measurement, Berg Balance Scale, and Dysarthria Assessment Scale were not significantly different before and after treatment. These findings suggest that peripheral blood mononuclear cell transplantation into the subarachnoid space for the treatment of amyotrophic lateral sclerosis is safe, but its therapeutic effect is not remarkable. Thus, a large-sample investigation is needed to assess its efficacy further.

  15. Lonizing radiation regulations and the dental practitioner: 3. Quality assurance in dental radiography.

    PubMed

    Rout, John; Brown, Jackie

    2012-06-01

    This is the last in a series of three articles on X-ray dose reduction and covers aspects of quality assurance. The first outlined radiation physics and protection and the second the legislation relating to radiation safety. Quality assurance is an essential part of dental radiography and is required to produce images of a consistently high standard, necessary for accurate diagnosis.

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

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  17. 10 CFR 74.59 - Quality assurance and accounting requirements.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Section 74.59 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) MATERIAL CONTROL AND ACCOUNTING OF SPECIAL NUCLEAR MATERIAL Formula Quantities of Strategic Special Nuclear Material § 74.59 Quality assurance and... method listed in § 74.6, to the Director, Office of Nuclear Material Safety and Safeguards, any...

  18. Operating and Assurance Program Plan. Revision 4

    SciTech Connect

    Not Available

    1994-07-01

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

  19. Blood-stage challenge for malaria vaccine efficacy trials: a pilot study with discussion of safety and potential value.

    PubMed

    Sanderson, Frances; Andrews, Laura; Douglas, Alexander D; Hunt-Cooke, Angela; Bejon, Philip; Hill, Adrian V S

    2008-06-01

    There is increasing interest in malaria vaccines targeting the asexual blood stage of Plasmodium falciparum. Without accepted immunologic correlates of clinical protection, challenge studies are useful for assessing the efficacy of candidate vaccines in vivo in healthy volunteers. We report a pilot study of a safe and robust challenge protocol using a blood-stage inoculum. We have applied well-validated trial endpoints and twice daily real-time quantitative polymerase chain reaction monitoring of parasitemia to blood-stage challenge, which enabled direct comparison with sporozoite challenge. We found that greater accuracy in quantification of blood-stage growth rates can be achieved with blood-stage challenge. This finding may provide greater power to detect partial efficacy of many blood-stage candidate vaccines. We discuss the potential utility of blood-stage challenge studies in accelerating malaria vaccine development.

  20. [Quality assurance under professional law and law relating to health services physicians and doctors].

    PubMed

    Ratzel, R

    1998-01-01

    Medical quality assurance is guaranteed by a partially supplementary and partially contradictory systemframework of professional provisions as well as the provisions that apply to health service physicians. As far as qualifications are concerned, quality assurance is primarily the responsibility of the medical boards. Competing provisions are to be found particularly in the area of process quality. With a view to co-ordinating them, the Work Group for the Promotion of Quality Assurance in Medicine has been set up, sponsored by the Federal Medical Board, the Federal Association of National Health Service Physicians, the German Hospital Organisation and the leading statutory health insurance associations. The role of the Federal Medical Board in the field of quality assurance has been considerably upgraded pursuant to the Second Reform Index [II. NOG]. The article refers to several quality assurance projects, exploring in depth, for example, quality assurance in the areas of blood group identification and blood transfusion.

  1. Construction quality assurance report

    SciTech Connect

    Roscha, V.

    1994-09-08

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

  2. 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

  3. Quality Assurance and Nursing Education

    ERIC Educational Resources Information Center

    Strauss, Mary Beth

    1978-01-01

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

  4. Recent Trends in Quality Assurance

    ERIC Educational Resources Information Center

    Amaral, Alberto; Rosa, Maria Joao

    2010-01-01

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

  5. Printed Circuit Board Quality Assurance

    NASA Technical Reports Server (NTRS)

    Sood, Bhanu

    2016-01-01

    PCB Assurance Summary: PCB assurance actives are informed by risk in context of the Project. Lessons are being applied across Projects for continuous improvements. Newer component technologies, smaller/high pitch devices: tighter and more demanding PCB designs: Identifying new research areas. New materials, designs, structures and test methods.

  6. The risk of transfusion-acquired hepatitis-C virus infection among blood donors in Port Harcourt: the question of blood safety in Nigeria.

    PubMed

    Erhabor, O; Ejele, O A; Nwauche, C A

    2006-06-01

    This study was undertaken to establish the sero-epidemology of Hepatitis C Virus (HCV) antibodies among blood donors in Port Harcourt, Nigeria. One Thousand Five Hundred consecutive blood donors presenting to the blood transfusion unit of the University of Port Harcourt Teaching Hospital between January and April, 2003 comprising of 1481 males and 19 females were screened for hepatitis C antibodies using the commercially available Clinotech anti-HCV test strips. All initially positive samples were subsequently tested using a second-generation Trinity Biotec enzyme linked immunosorbent assay. HCV antibodies were detected in 7 (0.5%) of donors. Although statistically not significant, the overall sero prevalence of HCV antibodies was higher in males 7 (0.5%) compared to zero prevalence among females. (chi-squared = 1.94, p = 1.000). Commercial remunerated donors had a higher prevalence of anti-HCV anti-bodies 5 (0.8%) compared to family replacement donors (0.2%) (chi-squared = 1.25, p = 0.26). The highest infection rate occurred in the 18 - 27 years age group 7 (0.7%). This study shows a 0.5% prevalence of HCV antibodies among blood donors and describes their demographic characteristics. This calls for urgent implementation of a universal donor screening for HCV antibodies and setting up of a national blood transfusion service run on the basis of voluntary, non-remunerated low risk donors.

  7. The Safety and Therapeutic Effectiveness of Nonwashed Mediastinal Shed Blood Reinfused Into Patients Following Open Heart Surgery

    DTIC Science & Technology

    1992-05-06

    randomized study was designed to test the hypothesis that use of nonwashed shed mediastinal blood may exacerbate platelet dysfunction following...Brea, CA). Total protein and albumin levels were measured by the Biuret reactions method of Kingsley [11]. Factor V (% normal), Factor VIII...transfusion (shed blood vs. banked blood), throughout the course of the study. When a significant change was noted by MANOVA, the paired t- test was used

  8. Safety and Tolerability of HSC835 in Patients With Hematological Malignancies Undergoing Single Umbilical Cord Blood Transplant

    ClinicalTrials.gov

    2017-08-31

    Single Umbilical Cord Blood Transplantation; Non-myeloablative Conditioning; Acute Lymphocytic Leukemia; Myelodysplastic Syndrome; Non-Hodgkin's Lymphoma; Multiple Myeloma; Chronic Lymphocytic Leukemia

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

    PubMed

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

    2013-01-01

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

  10. Goal Structuring Notation in a Radiation Hardening Assurance Case for COTS-Based Spacecraft

    DTIC Science & Technology

    2016-03-31

    assurance case using Goal Structuring Notation (GSN) for spacecraft containing COTS parts. The GSN paradigm is applied to an SRAM single-event upset...or damage to an electronic device such as single- event latch up. The goal of this effort is to use GSN as a paradigm to create a safety case to... knowledge embodied by the models is drawn on for the assurance or safety case. The case itself can exist as a linked hierarchy facilitating a

  11. A carrier-mediated transport of toxins in a hybrid membrane. Safety barrier between a patients blood and a bioartificial liver.

    PubMed

    Stange, J; Mitzner, S

    1996-11-01

    Combination of detoxifying liver support systems with liver cell bioreactors may have additional benefits for the treatment of liver failure due to the replacement of known and unknown metabolic activities of the liver. However, the problem of side effects and possible risks caused by the use of animal hepatocytes or hepatoma cells remains unsolved which underlines the need of a safety barrier between the patients blood and the extracorporeal bioreactor. Passive filters do not meet the requirements of such membranes, because in liver failure desired and undesired molecules in the patients blood share similar physicochemical properties. That challenges the development of biologically designed separation membranes. A hybrid membrane is formed by implementation of transport proteins into a highly permeable hollow fiber. The transport of free solutes and albumin bound toxins is tested in vitro in comparison with conventional high flux membranes. The transport characteristics for tightly albumin bound toxins are significantly improved for the hybrid membrane. The transport of albumin bound toxins across the membrane is not associated with albumin. The selectivity of the transport is evaluated in vivo. No significant loss of middle molecular weight hormones attached to other carrier proteins was observed. Neither transport of immunologically relevant proteins across the membrane nor loss of valuable proteins was measured. Also in vivo, a significant reduction of protein bound toxins and a transport of metabolically relevant solutes, like amino acids, was shown. The presented hybrid membrane may be used like an "intelligent membrane" as a safety barrier between the patients blood and cell devices.

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

    ERIC Educational Resources Information Center

    Lakin, Charlie, Ed.; And Others

    1993-01-01

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

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

    NASA Technical Reports Server (NTRS)

    Wetherholt, Martha

    2010-01-01

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

  14. [Ballistic quality assurance].

    PubMed

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

    2012-06-01

    This review describes the ballistic quality assurance for stereotactic intracranial irradiation treatments delivered with Gamma Knife® either dedicated or adapted medical linear accelerators. Specific and periodic controls should be performed in order to check the mechanical stability for both irradiation and collimation systems. If this step remains under the responsibility of the medical physicist, it should be done in agreement with the manufacturer's technical support. At this time, there are no recent published guidelines. With technological developments, both frequency and accuracy should be assessed in each institution according to the treatment mode: single versus hypofractionnated dose, circular collimator versus micro-multileaf collimators. In addition, "end-to-end" techniques are mandatory to find the origin of potential discrepancies and to estimate the global ballistic accuracy of the delivered treatment. Indeed, they include frames, non-invasive immobilization devices, localizers, multimodal imaging for delineation and in-room positioning imaging systems. The final precision that could be reasonably achieved is more or less 1mm. Copyright © 2012 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.

  15. Process measurement assurance program

    SciTech Connect

    Pettit, R.B.

    1996-05-01

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

  16. Quality assurance and accreditation.

    PubMed

    1997-01-01

    In 1996, the Joint Commission International (JCI), which is a partnership between the Joint Commission on Accreditation of Healthcare Organizations and Quality Healthcare Resources, Inc., became one of the contractors of the Quality Assurance Project (QAP). JCI recognizes the link between accreditation and quality, and uses a collaborative approach to help a country develop national quality standards that will improve patient care, satisfy patient-centered objectives, and serve the interest of all affected parties. The implementation of good standards provides support for the good performance of professionals, introduces new ideas for improvement, enhances the quality of patient care, reduces costs, increases efficiency, strengthens public confidence, improves management, and enhances the involvement of the medical staff. Such good standards are objective and measurable; achievable with current resources; adaptable to different institutions and cultures; and demonstrate autonomy, flexibility, and creativity. The QAP offers the opportunity to approach accreditation through research efforts, training programs, and regulatory processes. QAP work in the area of accreditation has been targeted for Zambia, where the goal is to provide equal access to cost-effective, quality health care; Jordan, where a consensus process for the development of standards, guidelines, and policies has been initiated; and Ecuador, where JCI has been asked to help plan an approach to the evaluation and monitoring of the health care delivery system.

  17. 49 CFR 385.321 - What failures of safety management practices disclosed by the safety audit will result in a...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

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

    PubMed

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

    2014-05-01

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

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

    SciTech Connect

    1986-01-01

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

  20. New challenges in assuring vaccine quality.

    PubMed Central

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

    2000-01-01

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

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

    PubMed

    Engle, Steven K; Watson, David E

    2016-02-01

    Cardiovascular (CV) toxicity is an important cause of failure during drug development. Blood-based biomarkers can be used to detect CV toxicity during preclinical development and prioritize compounds at lower risk of causing such toxicities. Evidence of myocardial degeneration can be detected by measuring concentrations of biomarkers such as cardiac troponin I and creatine kinase in blood; however, detection of functional changes in the CV system, such as blood pressure, generally requires studies in animals with surgically implanted pressure transducers. This is a significant limitation because sustained changes in blood pressure are often accompanied by changes in heart rate and together can lead to cardiac hypertrophy and myocardial degeneration in animals, and major adverse cardiovascular events (MACE) in humans. Increased concentrations of NPs in blood correlate with higher risk of cardiac mortality, all-cause mortality, and MACE in humans. Their utility as biomarkers of CV function and toxicity in rodents was investigated by exploring the relationships between plasma concentrations of NTproANP and NTproBNP, blood pressure, heart rate, and heart weight in Sprague Dawley rats administered compounds that caused hypotension or hypertension, including nifedipine, fluprostenol, minoxidil, L-NAME, L-thyroxine, or sunitinib for 1-2 weeks. Changes in NTproANP and/or NTproBNP concentrations were inversely correlated with changes in blood pressure. NTproANP and NTproBNP concentrations were inconsistently correlated with relative heart weights. In addition, increased heart rate was associated with increased heart weights. These studies support the use of natriuretic peptides and heart rate to detect changes in blood pressure and cardiac hypertrophy in short-duration rat studies. © The Author 2015. Published by Oxford University Press on behalf of the Society of Toxicology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

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

    PubMed

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

    2010-01-01

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

  3. Hepatitis E virus in the countries of the Middle East and North Africa region: an awareness of an infectious threat to blood safety.

    PubMed

    Yazbek, Soha; Kreidieh, Khalil; Ramia, Sami

    2016-02-01

    Hepatitis E virus (HEV) is mainly transmitted through contaminated water supplies which make the virus endemic in developing countries including countries of the Middle East and North Africa (MENA) region. Recent reports suggest potential risk of HEV transmission via blood transfusion. Related articles on HEV were collected by searching through the 25 countries of the MENA region using Pubmed and Medline within the past 14 years: January 2000-August 2014. One hundred articles were extracted, of which 25 were not eligible. The articles discussed the seroprevalence of HEV and HEV markers in 12 countries. Eight articles provided data on HEV in blood donors. The seroprevalence of HEV in the general MENA population ranged from 2.0 to 37.5% and was higher in males than in females. Prevalence increased with age, but exposure seems to be in early life. In the MENA region, the role of HEV as an infectious threat to blood safety is under-investigated. More data are needed to quantify the risk of transmission and to assess clinical outcomes. This requires, at least, surveillance screening of donors and recipients for HEV markers using sensitive and specific serological tests. At the present time, serious consideration should be given to selective screening for certain groups of patients (e.g., immunocompromised, pregnant women and others) who commonly require blood transfusion and are at high risk of hepatic failure or chronicity from HEV infection.

  4. BUILDING "BRIDGES" WITH QUALITY ASSURANCE

    EPA Science Inventory

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

  5. [Quality assurance in medical care].

    PubMed

    Oberender, P; Daumann, F

    1996-01-01

    The demand for quality assurance in Germany's health care system has been on the increase since promulgation of the Germany Statutory Health Service Reform law. To control, to assure and to improve quality a vast array of different systems is used by health care providers. All these systems work in a similar manner. The desired level of quality is determined and compared with the actually achieved level. If a deviation of quality is observed, actions for quality improvement are instituted. However, there are some problems that make quality assurance a difficult problem. Since the level of quality is a result of a patient's individual evaluation it is very difficult to set a common level. Another problem is to find valid criteria to measure the degree of quality. Finally, further research is necessary to analyse benefits and costs of introducing a quality assurance system.

  6. Radiation shielding quality assurance

    NASA Astrophysics Data System (ADS)

    Um, Dallsun

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

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

    PubMed

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

    2016-05-01

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

  8. The NOνA Module Factory Quality Assurance System

    NASA Astrophysics Data System (ADS)

    Smith, Alex; the NOνA Collaboration

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

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

    NASA Astrophysics Data System (ADS)

    Feng, D.; Eyster, C.

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

  10. Cord blood banking and quality issues.

    PubMed

    Murphy, Amanda; McKenna, David; McCullough, Jeffrey

    2016-03-01

    Food and Drug Administration guidelines are designed to assure the quality and safety of the cord blood product used for transplantation. It is valuable to determine whether the actions called for in these guidelines are effective. We applied our cell therapy quality system to all cord blood units shipped into our cellular therapy laboratory for transplant at the University of Minnesota between 2011 and 2013. The quality issues were categorized as likely, potentially, or unlikely to have a clinical impact. A total of 249 units of umbilical cord blood (UCB) were received from 16 cord blood banks. A total of 159 units (64%) had a total of 245 issues. Of these, 117 (48%) pertained to medical history, 120 (49%) to quality control, and eight (3%) to labeling and documentation. Units with quality issues were no more likely to fail to engraft, and no specific kind of quality issue was associated with failure to engraft. Compared to a similar study 10 years ago, there was a decrease in the number of issues per unit. The cost of collecting, testing, processing, and storing UCB is very high. However, there may be activities that do not contribute to the quality or safety of the cord blood. The guidelines could be reviewed to determine their value based on years of experience. © 2015 AABB.

  11. First-time whole blood donation: A critical step for donor safety and retention on first three donations.

    PubMed

    Gillet, P; Rapaille, A; Benoît, A; Ceinos, M; Bertrand, O; de Bouyalsky, I; Govaerts, B; Lambermont, M

    2015-01-01

    Whole blood donation is generally safe although vasovagal reactions can occur (approximately 1%). Risk factors are well known and prevention measures are shown as efficient. This study evaluates the impact of the donor's retention in relation to the occurrence of vasovagal reaction for the first three blood donations. Our study of data collected over three years evaluated the impact of classical risk factors and provided a model including the best combination of covariates predicting VVR. The impact of a reaction at first donation on return rate and complication until the third donation was evaluated. Our data (523,471 donations) confirmed the classical risk factors (gender, age, donor status and relative blood volume). After stepwise variable selection, donor status, relative blood volume and their interaction were the only remaining covariates in the model. Of 33,279 first-time donors monitored over a period of at least 15 months, the first three donations were followed. Data emphasised the impact of complication at first donation. The return rate for a second donation was reduced and the risk of vasovagal reaction was increased at least until the third donation. First-time donation is a crucial step in the donors' career. Donors who experienced a reaction at their first donation have a lower return rate for a second donation and a higher risk of vasovagal reaction at least until the third donation. Prevention measures have to be processed to improve donor retention and provide blood banks with adequate blood supply. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  12. Thoughts on Internal and External Quality Assurance

    ERIC Educational Resources Information Center

    Zhang, Jianxin

    2012-01-01

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

  13. 10 CFR 71.37 - Quality assurance.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Quality assurance. 71.37 Section 71.37 Energy NUCLEAR... Package Approval § 71.37 Quality assurance. (a) The applicant shall describe the quality assurance program... quality assurance program that are applicable to the particular package design under...

  14. 10 CFR 71.37 - Quality assurance.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Quality assurance. 71.37 Section 71.37 Energy NUCLEAR... Package Approval § 71.37 Quality assurance. (a) The applicant shall describe the quality assurance program... quality assurance program that are applicable to the particular package design under...

  15. 10 CFR 71.37 - Quality assurance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Quality assurance. 71.37 Section 71.37 Energy NUCLEAR... Package Approval § 71.37 Quality assurance. (a) The applicant shall describe the quality assurance program... quality assurance program that are applicable to the particular package design under...

  16. 10 CFR 71.37 - Quality assurance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  17. 10 CFR 71.37 - Quality assurance.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Quality assurance. 71.37 Section 71.37 Energy NUCLEAR... Package Approval § 71.37 Quality assurance. (a) The applicant shall describe the quality assurance program... quality assurance program that are applicable to the particular package design under...

  18. Thoughts on Internal and External Quality Assurance

    ERIC Educational Resources Information Center

    Zhang, Jianxin

    2012-01-01

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

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

    PubMed Central

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

    2015-01-01

    Background Routine use of antifibrinolytic agents in spine surgery is still an issue of debate. Objective To gather scientific evidence for the efficacy and safety of antifibrinolytic agents including aprotinin, tranexamic acid (TXA) and epsilon aminocaproic acid (EACA, traditionally known as Amicar) in reducing perioperative blood loss and transfusion requirements in scoliosis surgery. Methods We conducted a systematic review and meta-analysis for randomized controlled trials (RCTs), retrospective case-control studies, and retrospective cohort studies on the use of antifibrinolytic agents in scoliosis surgery by searching in the MEDLINE and EMBASE databases and the Cochrane Database of Systematic Reviews and Controlled Trials of papers published from January 1980 through July 2014. Safety of the antifibrinolytic agents was evaluated in all included studies, while efficacy was evaluated in RCTs. Results Eighteen papers with a total of 1,158 patients were eligible for inclusion in this study. Among them, 8 RCTs with 450 patients were included for evaluation of pharmacologic efficacy (1 RCT was excluded because of a lack of standard deviation data). Mean blood loss was reduced in patients with perioperative use of antifibrinolytic agents by 409.25 ml intraoperatively (95% confidence interval [CI], 196.57–621.94 ml), 250.30 ml postoperatively (95% CI, 35.31–465.30), and 601.40 ml overall (95% CI, 306.64–896.16 ml). The mean volume of blood transfusion was reduced by 474.98 ml (95% CI, 195.30–754.67 ml). The transfusion rate was 44.6% (108/242) in the patients with antifibrinolytic agents and 68.3% (142/208) in the patients with placebo. (OR 0.38; 95% CI; 0.25–0.58; P<0.00001, I2 = 9%). All studies were included for evaluation of safety, with a total of 8 adverse events reported overall (4 in the experimental group and 4 in the control group). Conclusion The systematic review and meta-analysis indicated that aprotinin, TXA, and EACA all significantly reduced

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

    PubMed

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

    2013-12-01

    Blood bank regulatory agencies including the Drug and Cosmetics Act (DCA) of India do not mandate a predonation platelet count in whole blood donation. Mandating such practice will definitely optimize the quality of random donor platelets (RDP) in terms of platelet yield and patient therapeutic benefit. We observed poor platelet yield in RDP concentrates prepared at our center with a significant number not meeting the DCA guideline of ≥ 4.5 × 10(10) per bag processed from 450 ml of whole blood. Therefore we planned this study to evaluate the pre-donation hematological values in our blood donor population and effect of these values on the quality of platelet concentrates. The prospective study included 221 blood donors eligible for donating 450 ml of whole blood (WB). Following the departmental standard operating procedure (SOP) RDPs were prepared using the 'Top & Bottom' quadruple bag system and automated component extractor. Quality of RDP was assessed as per departmental protocol. All results were recorded and subsequently transcribed to SPSS working sheet. A significant (p<0.001) decrement of donor blood counts has been observed after WB donation. Mean donor Hb and platelets reduced by 0.72 g/dl and 22.1 × 10(6)/ml respectively. Quality of RDPs in terms of platelet yield was significantly better (p<0.001) when donor platelet count was >200 × 10(6)/ml. Although platelet yield significantly correlated with the donor platelet count however quality of RDPs in terms of red cell contamination showed no correlation with the donor hematocrit. Platelet yield in random donor platelets is a concern in Eastern India. A platelet yield of 4.5 × 10(10) per bag as mandated by the DCA of India was only achieved when the donor platelet count was >200 × 10(6)/ml. Posttransfusion platelet recovery (PPR) was unsatisfactory in the transfused patient. Introduction of pre-donation platelet count in whole blood donation will maximize donor safety and optimize patient platelet