WorldWideScience

Sample records for regulatory instrument review

  1. Regulatory instrument review: Management of aging of LWR [light water reactor] major safety-related components

    International Nuclear Information System (INIS)

    Werry, E.V.

    1990-10-01

    This report comprises Volume 1 of a review of US nuclear plant regulatory instruments to determine the amount and kind of information they contain on managing the aging of safety-related components in US nuclear power plants. The review was conducted for the US Nuclear Regulatory Commission (NRC) by the Pacific Northwest Laboratory (PNL) under the NRC Nuclear Plant Aging Research (NPAR) Program. Eight selected regulatory instruments, e.g., NRC Regulatory Guides and the Code of Federal Regulations, were reviewed for safety-related information on five selected components: reactor pressure vessels, steam generators, primary piping, pressurizers, and emergency diesel generators. Volume 2 will be concluded in FY 1991 and will also cover selected major safety-related components, e.g., pumps, valves and cables. The focus of the review was on 26 NPAR-defined safety-related aging issues, including examination, inspection, and maintenance and repair; excessive/harsh testing; and irradiation embrittlement. The major conclusion of the review is that safety-related regulatory instruments do provide implicit guidance for aging management, but include little explicit guidance. The major recommendation is that the instruments be revised or augmented to explicitly address the management of aging

  2. Regulatory instrument review: Aging management of LWR cables, containment and basemat, reactor coolant pumps, and motor-operated valves

    International Nuclear Information System (INIS)

    Werry, E.V.; Somasundaram, S.

    1995-09-01

    The results of Stage 2 of the Regulatory Instrument Review are presented in this volume. Selected regulatory instruments, such as the Code of Federal Regulations (CFR), US Nuclear Regulatory Commission (NRC), Regulatory Guides, and ASME Codes, were investigated to determine the extent to which these regulations apply aging management to selected safety-related components in nuclear power plants. The Regulatory Instrument Review was funded by the NRC under the Nuclear Plant Aging Research (NPAR) program. Stage 2 of the review focused on four safety-related structures and components; namely, cables, containment and basemat, reactor coolant pumps, and motor-operated valves. The review suggests that the primary-emphasis of the regulatory instruments was on the design, construction, start-up, and operation of a nuclear power plant, and that aging issues were primarily addressed after an aging-related problem was recognized. This Stage 2 review confirms the results of the prior review; (see Regulatory Instrument Review: Management of Aging of LWR Major Safety-Related Components NUREG/CR-5490. The observations indicate that the regulations generally address management of age-related degradation indirectly. Specific age-related degradation phenomena frequently are dealt with in bulletins and notices or through generic issues, letters, etc. The major recommendation of this report, therefore, is that the regulatory instruments should more directly and explicitly address the aging phenomenon and the management of the age-related degradation process

  3. 'Green' preferences as regulatory policy instrument

    International Nuclear Information System (INIS)

    Brennan, Timothy J.

    2006-01-01

    We examine here the suggestion that if consumers in sufficient numbers are willing to pay the premium to have power generated using low-emission technologies, tax or permit policies become less necessary or stringent. While there are implementation difficulties with this proposal, our purpose is more fundamental: Can economics make sense of using preferences as a regulatory instrument? If 'green' preferences are exogenously given, to what extent can or should they be regarded as a substitute for other policies? Even with 'green' preferences, production and consumption of polluting goods continue to impose social costs not borne in the market. Moreover, if green preferences are regarded as a policy instrument, the 'no policy' baseline would require a problematic specification of counterfactual 'non-green' preferences. Viewing green preferences as a regulatory policy instrument is conceptually sensible if the benchmark for optimal emissions is based on value judgments apart from the preferences consumers happen to have. If so, optimal environmental protection would be defined by reference to ethical theory, or, even less favorably, by prescriptions from policy advocates who give their own preferences great weight while giving those of the public at large (and the costs they bear) very little consideration. (author)

  4. Key Regulatory Issues for Digital Instrumentation and Control Systems at Nuclear Power Plants

    International Nuclear Information System (INIS)

    Korsah, Kofi; Wood, Richard Thomas

    2008-01-01

    To help reduce the uncertainty associated with application of digital instrumentation and controls (I and C) technology in nuclear power plants, the Nuclear Regulatory Commission (NRC) has issued six Interim Staff Guidance (ISG) documents that address the current regulatory positions on what are considered the significant digital I and C issues. These six documents address the following topics: Cyber Security, Diversity and Defense-in-Depth, Risk Informed Digital I and C Regulation, Communication issues, Human Factors and the Digital I and C Licensing Process (currently issued as Draft). After allowing for further refinement based on additional technical insight gathered by NRC staff through near-term research and detailed review of relevant experience, it is expected that updated positions ultimately will be incorporated into regulatory guides and staff review procedures. This paper presents an overview of the guidance provided by the NRC-issued ISGs on key technology considerations (i.e., the first five documents above) for safety-related digital I and C systems.

  5. Review of regulatory requirements relevant to calibration of monitoring instruments in research reactors

    Energy Technology Data Exchange (ETDEWEB)

    Gomaa, Hassan; Khedr, Ahmed; El-Din Talha, Kamal [Egyptian Nuclear and Radiological Regulatory Authority, Cairo (Egypt). Nuclear Safety Engineering Dept.

    2015-05-15

    The objective of this work is to demonstrate the regulatory requirements pertaining to calibration of monitoring instruments in research reactors. The regulatory statements concerning this subject in IAEA safety standards and the implementation of such regulations in twelve countries with different levels of nuclear programs are surveyed: Australia, Bulgaria, Canada, Egypt, Finland, Germany, Hungary, Slovenia, South Korea, Spain, United Kingdom of England and United States of America. In addition, the requirements of ISO/IEC17025 and NUPIC (Nuclear Utilities Procurement Issues Committee) are compared. Seven technical and administrate aspects are suggested as the comparison criteria and the explicit expression of the statements, the level of document (i.e.: act, requirement or guide) are the considered resources. The main differences and similarities between the different approaches are identified in order to provide an input for future development of the national regulations.

  6. Regulatory requirements on the calibration and use of survey instruments

    International Nuclear Information System (INIS)

    Domondon, D.B.

    1989-01-01

    Regulatory requirements on the provision, calibration and occasions of use of survey instruments are enumerated for a number of licensed activities. Two methods of calibrating survey instruments are described. Factors that must be taken into consideration in conducting calibrations, contents of calibration reports and of the sticker attached to the instrument which are needed for the correct use of the instrument are discussed. The precautions to be observed in order to insure correct use of survey instruments are described. (Auth.)

  7. 76 FR 59066 - Notice of Regulatory Review Plan

    Science.gov (United States)

    2011-09-23

    ... [No. 2011-N-10] Notice of Regulatory Review Plan AGENCY: Federal Housing Finance Agency. ACTION... of and requesting comments on the FHFA interim regulatory review plan for review of existing... comments on all aspects of the interim regulatory review plan, including legal and policy considerations...

  8. Regulatory requirements and quality assurance of radiation monitoring instruments

    International Nuclear Information System (INIS)

    Narasimharao, K.L.; Sharma, Ranjit

    2005-01-01

    The successful utilisation of radiation sources in the fields of medicine and industry requires the accurate measurement of activity, exposure rate and dose. Many varieties of instruments are in use for measurement of these parameters and new ones are being developed. The criteria for the design of the radiation monitoring instrument include the type and intensity of the radiation, purpose of measurement and ruggedness of the instrument. Quality and reliability of radiation monitoring instruments ensure that individuals are adequately protected. Accuracy, response time and ruggedness are required to be as per the approved/ prescribed guidelines. Regulatory authorities outline the design and performance criteria for radiation monitoring instruments and prescribe the recommendations of international agencies such as IAEA, ICRU and ISO for radiological measurement assurance programme. National Standards Laboratories all over the world prescribe procedures for calibration of various radiation monitoring instruments. The instruments should be calibrated as per these guidelines and should be traceable to national standards. The calibration traceable to national/ international standards and documentation as well as limits stipulated by the competent authority ensures the expected performance of the instrument. (author)

  9. Design reviews from a regulatory perspective

    International Nuclear Information System (INIS)

    Foster, B.D.

    1991-01-01

    This paper presents views on the role of the licensing engineer in the design process with specific emphasis on design reviews and the automated information management tools that support design reviews. The licensing engineer is seen as an important member of a design review team. The initial focus of the licensing engineer during design reviews is shown to be on ensuring that applicable regulatory requirements are addressed by the design. The utility of an automated tool, such as a commitments management system, to support regulatory requirements identification is discussed. The next responsibility of the licensing engineer is seen as verifying that regulatory requirements are transformed into measurable performance requirements. Performance requirements are shown to provide the basis for developing detailed design review criteria. Licensing engineer input during design reviews is discussed. This input is shown to be especially critical in cases where review findings may impact application of regulatory requirements. The use of automated tools in supporting design reviews is discussed. An information structure is proposed to support design reviews in a regulated environment. This information structure is shown to be useful to activities beyond design reviews. Incorporation of the proposed information structure into the Licensing Support System is proposed

  10. Research and regulatory review

    International Nuclear Information System (INIS)

    Macleod, J.S.; Fryer, D.R.H.

    1979-01-01

    To enable the regulatory review to be effectively undertaken by the regulatory body, there is a need for it to have ready access to information generated by research activities. Certain advantages have been seen to be gained by the regulatory body itself directly allocating and controlling some portion of these activities. The princial reasons for reaching this conclusion are summarised and a brief description of the Inspectorates directly sponsored programme outlined. (author)

  11. 3 CFR - Regulatory Review

    Science.gov (United States)

    2010-01-01

    ... as a means of promoting regulatory goals. The fundamental principles and structures governing... review. In this time of fundamental transformation, that process—and the principles governing regulation... the Office of Management and Budget (OMB) has reviewed Federal regulations. The purposes of such...

  12. Regulatory issues of digital instrumentation and control system in Lungmen project

    International Nuclear Information System (INIS)

    Chuang, C.F.; Chou, H.P.

    2004-01-01

    The Lungmen Nuclear Power Station (LNPS) is currently under construction in Taiwan, which consists of 2 advanced boiling water reactor (ABWR) units. The instrumentation and control (IC) systems of the LNPS are based on the state-of-the-art modernized fully integrated digital design. These IC systems possess many advantages and distinguished features comparing to traditional analog IC systems, they enjoy set-point stability, self-diagnostic and automatic testing ability, fault tolerance and avoidance, low power requirements, data handling and storage capability, as well as enhanced human-machine interfaces. This paper presents regulatory overviews, regulatory requirements, current major regulatory issues, as well as the areas of regulatory concerns and the lessons learned on the digital IC systems in the Lungmen Project

  13. Review of regulatory requirements for digital I and C systems

    Energy Technology Data Exchange (ETDEWEB)

    Kwon, Kee Choon; Lee, Cheol Kwon; Lee, Jang Soo [and others

    2001-11-01

    This work analyzed and summarized systematically various regulatory requirements that are necessary to develop digital nuclear instrumentation and control (I and C) systems, especially safety systems. The requirements are categorized into system, hardware, software, and quality assurance aspects. This report provides the explanations of terms and abbreviations to help readers understand. Furthermore, appendices of this report summarize the code and standards corresponding to each principal regulatory requirement. The hierarchical structure of regulatory requirements has Nuclear Energy Laws, Enforcement Regulations of Nuclear Energy Laws, and Notifications of Ministry of Science and Technology as utmost level requirements [In case of the US, 10 CFR 50 Appendix A, 10 CFR 50 Appendix B, 10 CFR 50.55a(h), 10 CFR 50.49, etc.]. The requirements include the Draft Regulatory Guidelines for Digital I and C Systems [In case of the US, Standard Review Plan (NUREG-0800), Regulatory Guide, Branch Technical Position (BTP)], KEPIC as standards [In case of the US, IEEE Standards, IEC Standards, ISA, Military Standard, etc.], and various reports issued by Korea Institute of Nuclear Safety [In case of the US, NUREG reports, EPRI reports, etc.]. This report can be referred for the development of safety grade control equipment, plant protection system, and engineered safety feature actuation system.

  14. Review of regulatory requirements for digital I and C systems

    International Nuclear Information System (INIS)

    Kwon, Kee Choon; Lee, Cheol Kwon; Lee, Jang Soo

    2001-11-01

    This work analyzed and summarized systematically various regulatory requirements that are necessary to develop digital nuclear instrumentation and control (I and C) systems, especially safety systems. The requirements are categorized into system, hardware, software, and quality assurance aspects. This report provides the explanations of terms and abbreviations to help readers understand. Furthermore, appendices of this report summarize the code and standards corresponding to each principal regulatory requirement. The hierarchical structure of regulatory requirements has Nuclear Energy Laws, Enforcement Regulations of Nuclear Energy Laws, and Notifications of Ministry of Science and Technology as utmost level requirements [In case of the US, 10 CFR 50 Appendix A, 10 CFR 50 Appendix B, 10 CFR 50.55a(h), 10 CFR 50.49, etc.]. The requirements include the Draft Regulatory Guidelines for Digital I and C Systems [In case of the US, Standard Review Plan (NUREG-0800), Regulatory Guide, Branch Technical Position (BTP)], KEPIC as standards [In case of the US, IEEE Standards, IEC Standards, ISA, Military Standard, etc.], and various reports issued by Korea Institute of Nuclear Safety [In case of the US, NUREG reports, EPRI reports, etc.]. This report can be referred for the development of safety grade control equipment, plant protection system, and engineered safety feature actuation system

  15. Guidelines for IAEA International Regulatory Review Teams (IRRTs)

    International Nuclear Information System (INIS)

    1993-04-01

    This document is intended to be used by International regulatory review teams in reviewing the activities of a regulatory body as applicable to the regulation of nuclear power plants. The mission will, however, take note of any other activities of the regulatory body when drawing up the review report. The document does not specifically deal with the functions of a regulatory body responsible for other types of nuclear facilities or related nuclear activities, but it is intended that the concepts presented in the document could be applied where appropriate. Refs

  16. Alternative approaches to pollution control and waste management: Regulatory and economic instruments

    International Nuclear Information System (INIS)

    Bernstein, J.D.

    1993-01-01

    The purpose of the paper is to present an overview of the most common strategies and policy instruments (that is, regulatory and economic) used in developed and developing countries to achieve pollution control and waste management objectives. Although this topic has been at the center of theoretical controversy both within and outside the World Bank, the paper is not intended to contribute to this debate. Rather, its purpose is to explore how regulatory and economic instruments are used to control air and water pollution, protect ground water, and manage solid and hazardous wastes. The paper is directed to policy makers at the national, state, and local levels of government, as well as to other parties responsible for pollution control and waste management programs

  17. Regulatory review of probabilistic safety assessment (PSA) Level 2

    International Nuclear Information System (INIS)

    2001-07-01

    Probabilistic safety assessment (PSA) is increasingly being used as part of the decision making process to assess the level of safety of nuclear power plants. The methodologies in use are maturing and the insights gained from the PSAs are being used along with those from deterministic analysis. Many regulatory authorities consider the current state of the art in PSA to be sufficiently well developed for results to be used centrally in the regulatory decision making process-referred to as risk informed regulation. For these applications to be successful, it will be necessary for the regulatory authority to have a high degree of confidence in the PSA. However, at the 1994 IAEA Technical Committee Meeting on Use of PSA in the Regulatory Process and at the OECD Nuclear Energy Agency Committee for Nuclear Regulatory Activities (CNRA) 'Special Issues' meeting in 1997 on Review Procedures and Criteria for Different Regulatory Applications of PSA, it was recognized that formal regulatory review guidance for PSA did not exist. The senior regulators noted that there was a need to produce some international guidance for reviewing PSAs to establish an agreed basis for assessing whether important technological and methodological issues in PSAs are treated adequately and to verify that conclusions reached are appropriate. In 1997, the IAEA and OECD Nuclear Energy Agency agreed to produce, in cooperation, guidance on Regulatory Review of PSA. This led to the publication of IAEA-TECDOC-1135 on the Regulatory Review of Probabilistic Safety Assessment (PSA) Level 1, which gives advice for the review of Level 1 PSA for initiating events occurring at power plants. This TECDOC extends the coverage to address the regulatory review of Level 2 PSA.These publications are intended to provide guidance to regulatory authorities on how to review the PSA for a nuclear power plant to gain confidence that it has been carried out to an acceptable level of quality so that it can be used as the

  18. The regulatory instruments for the correction of energy-related environmental externalities

    International Nuclear Information System (INIS)

    Labanderia Villot, X.; Lopez Otero, X.; Rodriguez Mendez, M.

    2007-01-01

    In this paper we deal with the different regulatory instruments for the correction of energy-related environmental externalities. This objective is justified by the size and general occurrence of this type of externalities in contemporary societies. In this sense, we distinguish between three main generations of instruments: conventional regulations, market mechanisms and voluntary approaches. In all cases, some practical examples of their application are presented, albeit emphasizing the experience with the so-called market instruments and the results of hypothetical simulations for the Spanish case. As a general conclusion we underline the role of economic analysis in the design, choice and evaluation of those mechanisms, which also explains the structure and contents of the article. (Author)

  19. Technical and regulatory challenges for digital instrumentation and control and control room systems in nuclear plants

    International Nuclear Information System (INIS)

    Torok, R.; Naser, J.; Harris, T.; Keithline, K.

    2006-01-01

    There are several unsettled technical and licensing issues in the areas of instrumentation and control (I and C), human factors, and updated control room designs that need coordinated, proactive industry attention. Some of these issues are already causing protracted regulatory reviews for existing plants, and left untreated, may cause substantial delays and increased costs for new plant combined construction and operating license approvals. Both industry and the NRC will have roles in resolving the key issues and addressing them in future design efforts and regulatory reviews. Where action is needed, the industry will want to minimize costs and risks by defining industry consensus solutions with corresponding technical bases. NEI has formed a working group to coordinate industry efforts and communications with NRC staff. The working group will also help determine priorities and coordinate both new and existing plant resources. EPRI will provide technical input and guidance for the working group. In order to be able to conduct reviews in a timely fashion, the NRC will likely need to enhance and expand staff resources as existing plants are upgraded and new plant reviews become more active. The industry initiative began with a workshop sponsored by EPRI and NEI on March 28-29, 2006, which led to the creation of the NEI working group. The working group has now identified and prioritized important generic issues, established resolution paths and schedules, and identified the roles of various stakeholders including utility companies, EPRI, NEI, vendors and the NRC. Through the course of this initiative I and C issues for both existing and new plants are being addressed. This paper describes the key I and C related technical and regulatory issues and their implications for new and operating plants, and provides a status report on the efforts to resolve them. (authors)

  20. Regulatory review of safety cases and safety assessments - associated challenges

    International Nuclear Information System (INIS)

    Bennett, D.G.; Ben Belfadhel, M.; Metcalf, P.E.

    2006-01-01

    Regulatory reviews of safety cases and safety assessments are essential for credible decision making on the licensing or authorization of radioactive waste disposal facilities. Regulatory review also plays an important role in developing the safety case and in establishing stakeholders' confidence in the safety of the facility. Reviews of safety cases for radioactive waste disposal facilities need to be conducted by suitably qualified and experienced staff, following systematic and well planned review processes. Regulatory reviews should be sufficiently comprehensive in their coverage of issues potentially affecting the safety of the disposal system, and should assess the safety case against clearly established criteria. The conclusions drawn from a regulatory review, and the rationale for them should be reproducible and documented in a transparent and traceable way. Many challenges are faced when conducting regulatory reviews of safety cases. Some of these relate to issues of project and programme management, and resources, while others derive from the inherent difficulties of assessing the potential long term future behaviour of engineered and environmental systems. The paper describes approaches to the conduct of regulatory reviews and discusses some of the challenges faced. (author)

  1. Information transmission in genetic regulatory networks: a review

    International Nuclear Information System (INIS)

    Tkacik, Gasper; Walczak, Aleksandra M

    2011-01-01

    Genetic regulatory networks enable cells to respond to changes in internal and external conditions by dynamically coordinating their gene expression profiles. Our ability to make quantitative measurements in these biochemical circuits has deepened our understanding of what kinds of computations genetic regulatory networks can perform, and with what reliability. These advances have motivated researchers to look for connections between the architecture and function of genetic regulatory networks. Transmitting information between a network's inputs and outputs has been proposed as one such possible measure of function, relevant in certain biological contexts. Here we summarize recent developments in the application of information theory to gene regulatory networks. We first review basic concepts in information theory necessary for understanding recent work. We then discuss the functional complexity of gene regulation, which arises from the molecular nature of the regulatory interactions. We end by reviewing some experiments that support the view that genetic networks responsible for early development of multicellular organisms might be maximizing transmitted 'positional information'. (topical review)

  2. Regulatory review of safety cases and safety assessments for near surface

    International Nuclear Information System (INIS)

    Nys, V.

    2003-01-01

    The activities of the ASAM Regulatory Review Working Group are presented. Regulatory review of the safety assessment is made. It includes the regulatory review of post-closure safety assessment; safety case development and confidence building. The ISAM methodology is reviewed and SA system description is presented. Recommendations on the review process management are given

  3. Regulatory review of probabilistic safety assessment (PSA) level 1

    International Nuclear Information System (INIS)

    2000-02-01

    Probabilistic safety assessment (PSA) is increasingly being used as part of the decision making process to assess the level of safety of nuclear power plants. The methodologies in use are maturing and the insights gained from the PSAs are being used along with those from the deterministic analysis. Many regulatory authorities consider that the current state of the art in PSA (especially Level 1 PSA) is sufficiently well developed that it can be used centrally in the regulatory decision making process - referred to as 'risk informed regulation'. For these applications to be successful, it will be necessary for regulatory authorities to have a high degree of confidence in PSA. However, at the IAEA Technical Committee Meeting on Use of PSA in the Regulatory Process in 1994 and at the OECD Nuclear Energy Agency Committee for Nuclear Regulatory Activities (CNRA) 'Special Issues' Meeting in 1997 on Review Procedures and Criteria for Different Regulatory Applications of PSA, it was recognized that formal regulatory review guidance for PSA did not exist. The senior regulators noted that there was a need to produce some international guidance for reviewing PSAs to establish an agreed basis for assessing whether important technological and methodological issues in PSAs are treated adequately and to verify that conclusions reached are appropriate. In 1997 the IAEA and OECD Nuclear Energy Agency agreed to produce in co-operation a technical document on the regulatory review of PSA. This publication is intended to provide guidance to regulatory authorities on how to review the PSA for a nuclear power plant to gain confidence that it has been carried out to an acceptable standard so that it can be used as the basis for taking risk informed decisions within a regulatory decision making process. The document gives guidance on how to set about reviewing a PSA and on the technical issues that need to be addressed. This publication gives guidance for the review of Level 1 PSA for

  4. Report of the Survey on the Design Review of New Reactor Applications. Volume 1 - Instrumentation and Control

    International Nuclear Information System (INIS)

    Downey, Steven

    2014-06-01

    At the tenth meeting of the CNRA Working Group on the Regulation of New Reactors (WGRNR) in March 2013, the members agreed to present the responses to the Second Phase, or Design Phase, of the Licensing Process Survey as a multi-volume text. As such, each report will focus on one of the eleven general technical categories covered in the survey. The general technical categories were selected to conform to the topics covered in the International Atomic Energy Agency (IAEA) Safety Guide GS-G-4.1. This report, which is the first volume, provides a discussion of the survey responses related to Instrumentation and Control (I and C). The Instrumentation and Control category includes the twelve following technical topics: Reactor trip system, actuation systems for Engineered Safety Features (ESF), safe shutdown system, safety-related display instrumentation, information and interlock systems important to safety, controls systems, main control room, supplementary control room, diverse I and C systems, data communication systems, software reliability and cyber-security. For each technical topic, the member countries described the information provided by the applicant, the scope and level of detail of the technical review, the technical basis for granting regulatory authorisation, the skill sets required and the Level of effort needed to perform the review. Based on a comparison of the information provided in response to the survey, the following observations were made: - Among the regulatory organisations that responded to the survey, there are similarities in the design information provided by an applicant. In most countries, the design information provided by an applicant includes, but is not limited to, a description of the I and C system design and functions, a description of the verification and validation programmes, and provisions for analysis, testing, and inspection of various I and C systems. - In addition to the regulations, it is a common practice for countries

  5. Regulatory review of NPP Krsko Periodic Safety Review

    International Nuclear Information System (INIS)

    Lovincic, D.; Muehleisen, A.; Persic, A.

    2004-01-01

    At the request of the Slovenian Nuclear Safety Administration (SNSA), Krsko NPP prepared a Periodic Safety Review (PSR) program in January 2001. This is the first PSR of NPP Krsko, the only nuclear power plant in Slovenia. The program was reviewed by the IAEA mission in May 2001 and approved by SNSA in July 2001. The program is made in accordance with the IAEA Safety Guide 'Periodic Safety Review of Operational Nuclear Power Plants' No. 50-SG-012 and with European practice. It contains a systematic review of operation of the NPP Krsko, including the review of the changes as a result of the modernization of the facility. The main tasks of PSR are review of plant status for each safety factor, development of aging and life cycle management program, review of seismic design and PSHA analysis and update of regulatory compliance program. The prioritization process of findings and action plan are also important tasks of PSR. The basic safety factors of the PSR review are: Operational Experience, Safety Assessment and Analyses, Equipment Qualification and Ageing Management, Safety Culture, Emergency Planing, Environmental Impact and Radioactive Waste, Compliance with license requirements and Prioritization. It had been agreed that SNSA will have reviewed all PSR reports generated during the PSR process. At the end of 2003 the PSR Summary Report with selected recommendations for action plan was completed and delivered to SNSA for review. The paper presents regulatory review of NPP Krsko PSR with emphasis on the evaluation of the PSR issues ranking process. (author)

  6. Use of risk information in regulatory reviews

    International Nuclear Information System (INIS)

    Sagar, B.; Benke, R.; Mohanty, S.

    2004-01-01

    The regulatory framework for licensing any high-level waste repository at Yucca Mountain in the United States, calls for appropriate use of risk information to ensure operational safety during the pre-closure period and long-term safety during the post-closure period. This paper focuses on the post-closure period. Regulations in the Code of Federal Regulations (CFR), Title 10, Part 63, apply to any repository at Yucca Mountain and envision use of probabilistic methods to develop quantitative risk information. Accumulated engineering and scientific experience at Yucca Mountain and analog sites and quantitative risk information from studies conducted by the implementer, regulator, and others are combined to formulate 'risk insights,' which are then used to plan and execute regulatory reviews. The U.S. Nuclear Regulatory Commission (NRC) and the Center for Nuclear Waste Regulatory Analyses (CNWRA) recently consolidated the knowledge gained during several g ears and developed such risk insights for the potential repository at Yucca Mountain. This paper discusses the types of risk information used to generate risk insights and how the risk insights will be used in regulatory reviews. A companion paper presents more details on sensitivity analysis methods used to generate risk information. (authors)

  7. Carbon Capture and Storage Legal and Regulatory Review. Edition 2

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-07-01

    The International Energy Agency (IEA) estimates that 100 carbon capture and storage (CCS) projects must be implemented by 2020 and over 3000 by 2050 if CCS is to fully contribute to the least-cost technology portfolio for CO2 mitigation. To help countries address the many legal and regulatory issues associated with such rapid deployment, the IEA launched the Carbon Capture and Storage Legal and Regulatory Review (CCS Review) in October 2010. The CCS Review gathers contributions by national and regional governments, as well as leading organisations engaged in CCS regulatory activities, to provide a knowledge-sharing forum that supports national-level CCS regulatory development. Each contribution provides a short summary of recent and anticipated developments and highlights a particular regulatory theme (such as financial contributions to long-term stewardship). To introduce each edition, the IEA provides a brief analysis of key advances and trends. Produced bi-annually, the CCS Review provides an up-to-date snapshot of global CCS regulatory developments. The theme for the second edition of the CCS Review, released in May 2011, is long-term liability for stored CO2. Other key issues addressed include: national progress towards implementation of the EU CCS Directive; developments in marine treaties relevant to CCS; international climate change negotiations; and the development process for CCS regulation.

  8. 76 FR 18457 - Regulatory Review Schedule; Tribal Consultation

    Science.gov (United States)

    2011-04-04

    ... that the NIGC provide tribal gaming commissions access to licensing information via an online database... DEPARTMENT OF THE INTERIOR National Indian Gaming Commission 25 CFR Chapter III Regulatory Review Schedule; Tribal Consultation AGENCY: National Indian Gaming Commission. ACTION: Notice of Regulatory...

  9. Regulatory Research of the PWR Severe Accident. Information Needs and Instrumentation for Hydrogen Control and Management

    Energy Technology Data Exchange (ETDEWEB)

    Park, Gun Chul; Suh, Kune Y.; Lee, Jin Yong; Lee, Seung Dong [Seoul Nat' l Univ., Seoul (Korea, Republic of)

    2001-03-15

    The current research is concerned with generation of basic engineering data needed in the process of developing hydrogen control guidelines as part of accident management strategies for domestic nuclear power plants and formulating pertinent regulatory requirements. Major focus is placed on identification of information needs and instrumentation methods for hydrogen control and management in the primary system and in the containment, development of decision-making trees for hydrogen management and their quantification, the instrument availability under severe accident conditions, critical review of relevant hydrogen generation model and phenomena In relation to hydrogen behavior, we analyzed the severe accident related hydrogen generation in the UCN 3{center_dot}4 PWR with modified hydrogen generation model. On the basis of the hydrogen mixing experiment and related GASFLOW calculation, the necessity of 3-dimensional analysis of the hydrogen mixing was investigated. We examined the hydrogen control models related to the PAR(Passive Autocatalytic Recombiner) and performed MAAP4 calculation in relation to the decision tree to estimate the capability and the role of the PAR during a severe accident.

  10. Regulatory Research of the PWR Severe Accident. Information Needs and Instrumentation for Hydrogen Control and Management

    International Nuclear Information System (INIS)

    Park, Gun Chul; Suh, Kune Y.; Lee, Jin Yong; Lee, Seung Dong

    2001-03-01

    The current research is concerned with generation of basic engineering data needed in the process of developing hydrogen control guidelines as part of accident management strategies for domestic nuclear power plants and formulating pertinent regulatory requirements. Major focus is placed on identification of information needs and instrumentation methods for hydrogen control and management in the primary system and in the containment, development of decision-making trees for hydrogen management and their quantification, the instrument availability under severe accident conditions, critical review of relevant hydrogen generation model and phenomena In relation to hydrogen behavior, we analyzed the severe accident related hydrogen generation in the UCN 3·4 PWR with modified hydrogen generation model. On the basis of the hydrogen mixing experiment and related GASFLOW calculation, the necessity of 3-dimensional analysis of the hydrogen mixing was investigated. We examined the hydrogen control models related to the PAR(Passive Autocatalytic Recombiner) and performed MAAP4 calculation in relation to the decision tree to estimate the capability and the role of the PAR during a severe accident

  11. Experts Complete IAEA Follow-up Review of Spanish Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: Nuclear safety experts today concluded an eight-day mission to review Spain's nuclear regulator, the Nuclear Safety Council (CSN). At the request of the Spanish Government, the International Atomic Energy Agency assembled a peer-review team of five high-level regulatory experts from four nations and two IAEA staff members to conduct a follow-up assessment of an Integrated Regulatory Review Service (IRRS) mission conducted in 2008. This follow-up IRRS mission examined CSN's progress in acting upon the recommendations and suggestions made during the 2008 IRRS mission and reviewed the areas of significant regulatory changes since that review. Both reviews covered safety and security regulatory aspects of all facilities and activities in Spain. The first mission reviewed Spain's regulatory framework against IAEA Safety Standards and fostered the exchange of information and experience on safety regulation. The mission also included a peer review of the security activities within the regulatory framework. IRRS team leader Luis Reyes, Senior Executive of the US Nuclear Regulatory Commission, said today, 'In 2008, the mission found particular strengths in CSN's policy, its regulatory framework and its regulatory activities. We made a number of suggestions and recommendations for further improvement of the regulatory framework. CSN should be commended for the significant amount of efforts in addressing all the findings identified in 2008 mission.' The review team found that CSN has made significant progress toward improving its regulatory activities. Most of the findings identified in the 2008 report have been effectively addressed and therefore can be considered closed. Additional findings are being addressed in accordance with a comprehensive and systematic action plan, in particular efforts to revise the CSN Statute. Complementing the CSN strengths identified during the 2008 mission, the 2011 IRRS team noted the following strengths: Improvements in regulatory

  12. Guidelines for IAEA International Regulatory Review Teams (IRRTs)

    International Nuclear Information System (INIS)

    2002-01-01

    The IAEA International Regulatory Review Team (IRRT) programme provides advice and assistance to Member States to strengthen and enhance the effectiveness of the nuclear regulatory body whilst recognizing the ultimate responsibility of each Member State for nuclear safety. The IRRT programme, initiated in 1989, is not restricted to any particular group of Member States, whether developing or industrialized, but is available to all countries with nuclear installations in operation or approaching operation. The basic concepts, purposes and functions of a national regulatory body are well recognized in all Member States having a nuclear power programme. The IAEA Safety Standards Series publication entitled 'Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, Safety: Requirements', No. GS-R-1 (2000), provides a general consensus reference for the practices necessary for a national organization to fulfil the regulatory purposes and discharge the regulatory functions. The Requirements also defines the terms used in these guidelines. The guidance given in the Requirements recognizes that the organizational structure and regulatory processes will vary from country to country depending on their existing constitutional, legal and administrative systems; the size and structure of their nuclear programme; the technical skills and professional and financial resources available to their regulatory body, and social customs and cultural traditions. The objective of this report is to provide guidance on the basic structure of an IRRT mission and provide a common reference both across the various areas covered by an IRRT mission and across all the missions in the programme. As such, it is addressed, principally, to the team members of IRRT missions but it also provides guidance to a host regulatory body receiving a mission. This report identifies the objectives of the IRRT mission and sets out the scope of the topic areas that are

  13. Literature Review of Multicultural Instrumentation

    Science.gov (United States)

    Sarraj, Huda; Carter, Stacy; Burley, Hansel

    2015-01-01

    Demographic changes at the national level emphasize a critical need for multicultural education to be included as part of undergraduate education. This critical review of the literature examines 10 multicultural instruments that are suitable for use in K-12 or higher education institutions. This is a novel literature review in that it is the first…

  14. Instruments for measuring mental health recovery: a systematic review.

    Science.gov (United States)

    Sklar, Marisa; Groessl, Erik J; O'Connell, Maria; Davidson, Larry; Aarons, Gregory A

    2013-12-01

    Persons in recovery, providers, and policymakers alike are advocating for recovery-oriented mental health care, with the promotion of recovery becoming a prominent feature of mental health policy in the United States and internationally. One step toward creating a recovery-oriented system of care is to use recovery-oriented outcome measures. Numerous instruments have been developed to assess progress towards mental health recovery. This review identifies instruments of mental health recovery and evaluates the appropriateness of their use including their psychometric properties, ease of administration, and service-user involvement in their development. A literature search using the Medline and Psych-INFO databases was conducted, identifying 21 instruments for potential inclusion in this review, of which thirteen met inclusion criteria. Results suggest only three instruments (25%) have had their psychometric properties assessed in three or more unique samples of participants. Ease of administration varied between instruments, and for the majority of instruments, development included service user involvement. This review updates and expands previous reviews of instruments to assess mental health recovery. As mental health care continues to transform to a recovery-oriented model of service delivery, this review may facilitate selection of appropriate assessments of mental health recovery for systems to use in evaluating and improving the care they provide. © 2013.

  15. International nuclear safety experts conclude IAEA peer review of Canada's regulatory system

    International Nuclear Information System (INIS)

    2009-01-01

    that indicate areas in which improvements are necessary or desirable to continue improving effectiveness of regulatory controls,' he said. 'These are made to an organization that seeks to improve its performance. Many of them are related to areas in which CNSC has already or is in the process of implementing a programme for change.' Mr. Tomihiro Taniguchi, IAEA Deputy Director General and Head of the Department for Nuclear Safety and Security, added: 'Through the IRRS missions, both a host country and the reviewers share their experiences and lessons learned for regulatory improvements. Canada, as a mature nuclear country has also significantly contributed to this goal.' Among the particular strengths of CNSC, its policy, its regulatory framework and its regulatory activities identified by the IRRS team were: - The Canadian legislative and regulatory framework is very comprehensive, and the legal regime is effectively applied through an appropriate range of instruments; - CNSC has done commendable work over the last years in establishing and implementing a strong management system that seeks continuous improvement within the organization; - The consistent harmonized plan that considers the results of all recent audits and assessments brings together all improvement initiatives under one plan and optimizes the use of resources to deliver further improvements in key areas; - The recommendations made by the Talisman International LLC report on the NRU and reviewed by the IRRS team have been adequately addressed by the CNSC. The IRRS team also made recommendations and suggestions that may significantly enhance the overall performance of the regulatory system. Examples include: - CNSC should initiate a periodic strategic planning programme to define both short- and long-term research activities needed to support pending and potential regulatory decisions. Sufficient resources should be allocated to support the results of the programme; - CNSC should continue developing a

  16. Nuclear Regulatory Commission staff approaches to improving the integration of regulatory guidance documents and prelicensing reviews

    International Nuclear Information System (INIS)

    Johnson, R.L.

    1994-01-01

    The Nuclear Regulatory Commission staff is conducting numerous activities to improve the integration of its regulatory guidance documents (i.e., License Application Review Plan (LARP) and open-quotes Format and Content for the License Application for the High-Level Waste repositoryclose quotes (FCRG)) and pre-license application (LA) reviews. Those activities related to the regulatory guidance documents consist of: (1) developing an hierarchy of example evaluation findings for LARP; (2) identifying LARP review plan interfaces; (3) conducting an integration review of LARP review strategies; (4) correlating LARP to the ongoing technical program; and (5) revising the FCRG. Some of the more important strategies the staff is using to improve the integration of pre-LA reviews with the LA review include: (1) use of the draft LARP to guide the staff's pre-LA reviews; (2) focus detailed pre-LA reviews on key technical uncertainties; (3) identify and track concerns with DOE's program; and (4) use results of pre-LA reviews in LA reviews. The purpose of this paper is to describe these ongoing activities and strategies and discuss some of the new work that is planned to be included in LARP Revision 1 and the final FCRG, which are scheduled to be issued in late 1994. These activities reflect both the importance the staff has placed on integration and the staff's approach to improving integration in these areas. The staff anticipates that the results of these activities, when incorporated in the FCRG, LARP, and pre-LA reviews, will improve its guidance for DOE's ongoing site characterization program and LA annotated outline development

  17. IAEA Mission Concludes Peer Review of Jordan's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2014-01-01

    Senior international nuclear safety and radiation protection experts today concluded an 11-day International Atomic Energy Agency (IAEA) Integrated Regulatory Review Service (IRRS) mission to review the regulatory framework for nuclear and radiation safety in Jordan. The mission team said in its preliminary findings that Jordan's nuclear regulator, the Energy and Minerals Regulatory Commission (EMRC), faces challenges because it is a relatively new body that handles a high workload while also working to recruit, train and keep competent staff. The team also noted that a recent merger provided the regulator with more of the resources it needs to perform its duty. The team made recommendations and suggestions to the regulatory body and the Government to help them strengthen the effectiveness of Jordan's regulatory framework and functions in line with IAEA Safety Standards. The main observations of the IRRS Review team comprised the following: The regulatory body, founded in 2007 and merged with other regulators in April 2014 to form EMRC, faces large challenges in terms of its regulatory workload, management system building and staff recruitment and training; The new EMRC structure and revision of the radiation and nuclear safety law represents an important opportunity to strengthen Jordan's radiation and nuclear safety infrastructure; The Government has shown commitment to radiation and nuclear safety through measures including becoming party to international conventions. It could further demonstrate its commitment by adopting a formal national policy and strategy for safety that defines the role of the Minister of Energy in relation to EMRC and protects the independence of regulatory decision-making

  18. Carbon Capture and Storage Legal and Regulatory Review. Edition 3

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2012-07-01

    The International Energy Agency (IEA) considers carbon capture and storage (CCS) a crucial part of worldwide efforts to limit global warming by reducing greenhouse-gas emissions. The IEA estimates that emissions can be reduced to a level consistent with a 2°C global temperature increase through the broad deployment of low-carbon energy technologies – and that CCS would contribute about one-fifth of emission reductions in this scenario. Achieving this level of deployment will require that regulatory frameworks – or rather a lack thereof – do not unnecessarily impede environmentally safe demonstration and deployment of CCS, so in October 2010 the IEA launched the IEA Carbon Capture and Storage Legal and Regulatory Review. The CCS Review is a regular review of CCS regulatory progress worldwide. Produced annually, it collates contributions by national and regional governments, as well as leading organisations engaged in CCS regulatory activities, to provide a knowledge-sharing forum to support CCS framework development. Each two page contribution provides a short summary of recent and anticipated CCS regulatory developments and highlights a particular, pre-nominated regulatory theme. To introduce each edition, the IEA provides a brief analysis of key advances and trends, based on the contributions submitted. The theme for this third edition is stakeholder engagement in the development of CO2 storage projects. Other issues addressed include: regulating CO2-EOR, CCS and CO2-EOR for storage; CCS incentive policy; key, substantive issues being addressed by jurisdictions taking steps to finalise CCS regulatory framework development; and CCS legal and regulatory developments in the context of the Clean Energy Ministerial Carbon Capture, Use and Storage Action Group.

  19. The quality of systematic reviews of health-related outcome measurement instruments.

    Science.gov (United States)

    Terwee, C B; Prinsen, C A C; Ricci Garotti, M G; Suman, A; de Vet, H C W; Mokkink, L B

    2016-04-01

    Systematic reviews of outcome measurement instruments are important tools for the selection of instruments for research and clinical practice. Our aim was to assess the quality of systematic reviews of health-related outcome measurement instruments and to determine whether the quality has improved since our previous study in 2007. A systematic literature search was performed in MEDLINE and EMBASE between July 1, 2013, and June 19, 2014. The quality of the reviews was rated using a study-specific checklist. A total of 102 reviews were included. In many reviews the search strategy was considered not comprehensive; in only 59 % of the reviews a search was performed in EMBASE and in about half of the reviews there was doubt about the comprehensiveness of the search terms used for type of measurement instruments and measurement properties. In 41 % of the reviews, compared to 30 % in our previous study, the methodological quality of the included studies was assessed. In 58 %, compared to 55 %, the quality of the included instruments was assessed. In 42 %, compared to 7 %, a data synthesis was performed in which the results from multiple studies on the same instrument were somehow combined. Despite a clear improvement in the quality of systematic reviews of outcome measurement instruments in comparison with our previous study in 2007, there is still room for improvement with regard to the search strategy, and especially the quality assessment of the included studies and the included instruments, and the data synthesis.

  20. Gender and Instrument Associations, Stereotypes, and Stratification: A Literature Review

    Science.gov (United States)

    Wych, Gina M. F.

    2012-01-01

    This literature review examines and synthesizes 30 years of research into the relationship between gender and musical instruments. Specifically, the review focuses on how this relationship affects instrument selection by grade school students entering a school music program. Topics include the gender typing of musical instruments, instrument…

  1. Review report: safety and reliability issues on digital instrumentation and control systems in nuclear power plants and United States Nuclear Regulatory Commission's dispositions

    International Nuclear Information System (INIS)

    Watanabe, Norio; Suzudo, Tomoaki

    1998-09-01

    Recently, digital instrumentation and control (I and C) systems have been applied to nuclear power plants (NPPs) in various countries. Introduction of digital I and C systems, however, raises special issues on design, implementation, safety and licensing. Since FY 1997, the Japan Atomic Energy Research Institute (JAERI) has been carrying out a project, Study on Reliability of Digital I and C Systems, which includes extensive reviews of design approaches, technical standards, regulatory processes, especially, in the United States. This report summarizes the results from the study of National Research Council (NRC) and the U.S. Nuclear Regulatory Commission's (USNRC's) responses to the recommendations made by the NRC's study. That study identified six technical key issues (system aspects of digital I and C technology, software quality assurance, common-mode software failure potential, safety and reliability assessment methods, human factors and man-machine interface, dedication of commercial off-the-shelf hardware and software) and two strategic key issues (case-by-case licensing process, adequacy of technical infrastructure) that arise from the introduction of digital I and C technology and then, made recommendations to the USNRC for coping with digital I and C applications. The USNRC responded to each recommendation and showed their own dispositions in which the USNRC agreed with most of the recommendations. In Japan, it is expected that introduction of digital I and C technology is inevitable in NPPs because the vendors are gradually discontinuing support and stocking of analog components. To cope with such situations, there is a need to develop and update the standards and guidelines applicable to digital I and C technology. The key issues and the USNRC's dispositions provided in this report is believed to be useful for developing and updating them. (J.P.N.)

  2. CMOS Electrochemical Instrumentation for Biosensor Microsystems: A Review

    Directory of Open Access Journals (Sweden)

    Haitao Li

    2016-12-01

    Full Text Available Modern biosensors play a critical role in healthcare and have a quickly growing commercial market. Compared to traditional optical-based sensing, electrochemical biosensors are attractive due to superior performance in response time, cost, complexity and potential for miniaturization. To address the shortcomings of traditional benchtop electrochemical instruments, in recent years, many complementary metal oxide semiconductor (CMOS instrumentation circuits have been reported for electrochemical biosensors. This paper provides a review and analysis of CMOS electrochemical instrumentation circuits. First, important concepts in electrochemical sensing are presented from an instrumentation point of view. Then, electrochemical instrumentation circuits are organized into functional classes, and reported CMOS circuits are reviewed and analyzed to illuminate design options and performance tradeoffs. Finally, recent trends and challenges toward on-CMOS sensor integration that could enable highly miniaturized electrochemical biosensor microsystems are discussed. The information in the paper can guide next generation electrochemical sensor design.

  3. IAEA Mission Concludes Peer Review of Pakistan's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2014-01-01

    An international team of senior nuclear safety experts today concluded a nine-day International Atomic Energy Agency (IAEA) mission to review the regulatory framework for the safety of operating nuclear power plants in the United States of America (USA). The Integrated Regulatory Review Service (IRRS) mission was a follow-up to the IRRS mission to the US Nuclear Regulatory Commission (NRC) that was conducted in 2010, with the key additional aim of reviewing whether the response of the US regulatory regime to the implications of the accident at TEPCO's Fukushima Daiichi Plant had been timely and effective. The mission team concluded that the recommendations and suggestions made by the 2010 IRRS mission have been taken into account systematically under the NRC's subsequent action plan, with significant progress in many areas and many improvements carried out. One of two recommendations and 19 out of 20 suggestions made by the 2010 IRRS mission have been effectively addressed and can therefore be considered closed. The outstanding recommendation relates to the NRC's review of its Management System, which is in the process of being finalised. The IRRS team also found that the NRC acted promptly and effectively after the Fukushima accident in the interests of public health and safety, and that the report of its Near-Term Task Force represents a sound and ample basis for taking into account the lessons learned from the accident

  4. IAEA Mission Concludes Peer Review of Slovenia's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2014-01-01

    Senior international nuclear safety and radiation protection experts today concluded an eight-day International Atomic Energy Agency (IAEA) mission to review the regulatory framework for nuclear and radiation safety at the Slovenian Nuclear Safety Administration (SNSA). The team reviewed measures taken to address the recommendations and suggestions made during an earlier Integrated Regulatory Review Service (IRRS) mission conducted in 2011. The IRRS team said in its preliminary findings that Slovenia had made significant progress since the review in 2011. The team identified a good practice in the country's nuclear regulatory system additional to those identified in 2011 and made new recommendations and suggestions to SNSA and the Government to strengthen the effectiveness of the country's regulatory framework in line with IAEA Safety Standards. ''By hosting a follow-up mission, Slovenia demonstrated its commitment to enhance its regulatory programmes, including by implementing the recommendations of the 2011 mission,'' said Petr Krs, mission leader and Vice Chairman of the Czech Republic's State Office for Nuclear Safety. SNSA's Director, Andrej Stritar, welcomed the progress noted by the team, while also emphasizing that the mission highlighted important future nuclear safety challenges for Slovenia. The five-member review team, comprising experts from Belgium, the Czech Republic, France and Romania, as well as four IAEA staff members, conducted the mission at the request of the Slovenian Government from 9 to 16 September 2014. The main observations of the IRRS Review team included the following: SNSA has made significant progress in addressing the findings of the 2011 IRRS mission and has demonstrated commitment to effective implementation of the IRRS programme; The economic situation in Slovenia might in the short and long term affect SNSA's ability to maintain its capacity and competence; and A radioactive waste disposal project is stalled and the licensing

  5. Policy instruments for pollution control in developing countries.

    Science.gov (United States)

    Eskeland, G S; Jimenez, E

    1992-07-01

    Economic development in developing countries must be accomplished in a manner that does not harm the environment with pollution. Pollution harms human health and productivity. Thus appropriate strategies must be developed that promote growth, reduce poverty, and protect the environment. A review of the current literature is performed with attention paid to cost-effective interventions i.e., comparisons of regulatory and fiscal instruments that can reduce pollution. Both direct instruments (like effluent charges, tradable permits, deposit refund systems, emission regulations and regulatory agency funding for purification, cleanup, waste disposal, and enforcement) and indirect instruments (like input/output taxes and subsidies, substitution subsidies, abatement inputs, regulation of equipment and processes, and development of clean technologies) are examined. Examples are used to show how indirect instruments can be successful when monitoring and enforcement is too costly. A careful examination of distributive concerns illustrate how the effect on the poor may need particular consideration and how groups with vested interests can help evaluate the probable success of such interventions.

  6. Post-implementation review of inadequate core cooling instrumentation

    International Nuclear Information System (INIS)

    Anderson, J.L.; Anderson, R.L.; Hagen, E.W.; Morelock, T.C.; Huang, T.L.; Phillips, L.E.

    1988-01-01

    Studies of Three Mile Island (TMI) accident identified the need for additional instrumentation to detect inadequate core cooling (ICC) in nuclear power plants. Industry studies by plant owners and reactor vendors supported the conclusion that improvements were needed to help operators diagnose the approach to or existence of ICC and to provide more complete information for operator control of safety injection, flow to minimize the consequences of such an accident. In 1980, the US Nuclear Regulatory Commission (NRC) required further studies by the industry and described ICC instrumentation design requirements that included human factors and environmental considerations. On December 10, 1982, NRC issued to Babcock and Wilcox (BandW) licensees' orders for Modification of License and transmitted to all pressurized water reactor (PWR) licensees Generic Letter 82-28 to inform them of the revised NRC requirements. The instrumentation requirements for detection of ICC include upgraded subcooling margin monitors (SMMs), upgraded core exit thermocouples (CETs), and installation of a reactor coolant inventory tracking system (RCITS)

  7. Review of NRC Regulatory processes and functions

    International Nuclear Information System (INIS)

    1980-01-01

    The Advisory Committee on Reactor Safeguards (ACRS) has spent much time over many years observing and examining the NRC licensing process. The Committee is, consequently, in a position to comment on the situation, and it believes this review will be helpful to those examining the regulatory process by discussing how it works, where it is weak, and the opportunities for improvement. The Committee's review may also help put current proposals and discussions in perspective

  8. 76 FR 39234 - Federal Acquisition Regulation; Unique Procurement Instrument Identifier

    Science.gov (United States)

    2011-07-05

    ..., therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated... for procurement actions, such as delivery and task orders or basic ordering agreements, the order or... Instrument Identifier (PIID). Agencies shall have in place a process that ensures that each PIID reported to...

  9. Preparing and Conducting Review Missions of Instrumentation and Control Systems in Nuclear Power Plants

    International Nuclear Information System (INIS)

    2011-06-01

    The mission for Independent Engineering Review of Instrumentation and Control (I and C) Systems (IERICS) in Nuclear Power Plants (NPPs) has been established with the aim of conducting peer reviews of I and C design documents, implementation processes, prototype I and C systems, and actual systems already deployed in operating NPPs. Organizations in IAEA Member States, such as nuclear utilities, regulators, and technical support organizations can benefit from I and C technical reviews through requesting IERICS missions that provide a detailed technical assessment on I and C systems, as well as recommendations for improvement. The IERICS mission is conducted by a team of international subject matter experts from various complementing technical areas. The review is based on appropriate IAEA documents, such as Safety Guides and Nuclear Energy Series, and the mission's findings are summarized in a mission report, including a list of recommendations, suggestions, and identified good practices. The review is not intended to be a regulatory inspection or an audit against international codes and standards. Rather, it is a peer review aimed at improving design and implementation procedures through an exchange of technical experiences and practices at the working level. The IERICS mission is applicable at any stages of the life cycle of I and C systems in NPPs and it is initiated based on a formal request through official IAEA channels from an organization of a Member State. The formation of the IERICS mission is based on the recommendation of the IAEA Technical Working Group on Nuclear Power Plant Instrumentation and Control (TWG-NPPIC). The recommendation came from the recognition that the IAEA can play an important role in the independent assessment and review of NPP I and C systems in terms of their compliance with IAEA safety guides and technical documents.

  10. Organisation and experience of the regulatory review in the United Kingdom

    International Nuclear Information System (INIS)

    Gausden, R.; Woods, P.B.

    1979-01-01

    Regulatory requirements and stages of the review in the UK are outlined. The organisation, management and working procedures of the Inspectorate are described and the effort and timescale which have been found necessary for a satisfactory safety review is discussed. A number of problem areas in the review situation have been identified from experience and these are discussed and possible solutions proposed. They include the importance of early review of generic aspects of systems which are being considered for licensing, the place of safety principles and of detailed engineering assessment in the review process, the independence of the regulatory group's activities in its study of major technical issues and the use which should be made of outside expertise. (auth.)

  11. Review report: safety and reliability issues on digital instrumentation and control systems in nuclear power plants and United States Nuclear Regulatory Commission`s dispositions

    Energy Technology Data Exchange (ETDEWEB)

    Watanabe, Norio; Suzudo, Tomoaki [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment

    1998-09-01

    Recently, digital instrumentation and control (I and C) systems have been applied to nuclear power plants (NPPs) in various countries. Introduction of digital I and C systems, however, raises special issues on design, implementation, safety and licensing. Since FY 1997, the Japan Atomic Energy Research Institute (JAERI) has been carrying out a project, Study on Reliability of Digital I and C Systems, which includes extensive reviews of design approaches, technical standards, regulatory processes, especially, in the United States. This report summarizes the results from the study of National Research Council (NRC) and the U.S. Nuclear Regulatory Commission`s (USNRC`s) responses to the recommendations made by the NRC`s study. That study identified six technical key issues (system aspects of digital I and C technology, software quality assurance, common-mode software failure potential, safety and reliability assessment methods, human factors and man-machine interface, dedication of commercial off-the-shelf hardware and software) and two strategic key issues (case-by-case licensing process, adequacy of technical infrastructure) that arise from the introduction of digital I and C technology and then, made recommendations to the USNRC for coping with digital I and C applications. The USNRC responded to each recommendation and showed their own dispositions in which the USNRC agreed with most of the recommendations. In Japan, it is expected that introduction of digital I and C technology is inevitable in NPPs because the vendors are gradually discontinuing support and stocking of analog components. To cope with such situations, there is a need to develop and update the standards and guidelines applicable to digital I and C technology. The key issues and the USNRC`s dispositions provided in this report is believed to be useful for developing and updating them. (J.P.N.)

  12. Experts Complete IAEA Follow-up Review of Australia's Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: Nuclear and radiation safety experts today concluded an eight-day mission to review the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA), the country's nuclear regulator. At the request of the Australian Government, the International Atomic Energy Agency (IAEA) assembled a peer-review team of five regulatory experts from as many nations and three IAEA staff members to conduct a follow-up assessment of an Integrated Regulatory Review Service (IRRS) mission conducted in 2007. This follow-up IRRS mission examined ARPANSA's progress in acting upon the recommendations and suggestions made during the 2007 IRRS mission and reviewed the areas of significant regulatory changes since that review. Both reviews covered safety regulatory aspects of all facilities and activities regulated by ARPANSA. IRRS team leader Kaare Ulbak, Chief Advisor of Denmark's National Institute of Radiation Protection, said: ''ARPANSA should be commended for the significant amount of efforts in addressing all the findings identified in the 2007 mission and for inviting this follow-up review.'' The review team found that ARPANSA has made significant progress toward improving its regulatory activities, as most of the findings identified in the 2007 report have been effectively addressed and therefore can be considered closed. Complementing the ARPANSA strengths identified during the 2007 mission, the 2011 IRRS team noted the following strengths: Response to the Tepco Fukushima Dai-ichi accident; High level of in-house technical expertise in radiation safety; Recognition of the need and willingness to re-organize ARPANSA; Timely development of the national sealed source register in good coordination with other relevant organizations; and Creation of the Australian clinical dosimetry service and the national dose reference levels database. The 2011 IRRS team also made recommendations and suggestions to further strengthen ARPANSA's regulatory system, including: Making full

  13. Appetitive Pavlovian-instrumental Transfer: a review

    OpenAIRE

    Cartoni, Emilio; Balleine, Bernard; Baldassarre, Gianluca

    2016-01-01

    Reward-related cues are an important part of our daily life as they often influence and guide our actions. This paper reviews one of the experimental paradigms used to study the effects of cues, the Pavlovian to Instrumental Transfer paradigm. In this paradigm, cues associated with rewards through Pavlovian conditioning alter motivation and choice of instrumental actions. The first transfer experiments date back to the 1940s, but only in the last decade has it been fully recognised that there...

  14. International Nuclear Safety Experts Conclude IAEA Peer Review of Korea's Regulatory System

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: An international team of senior nuclear safety experts concluded today a two-week mission to review the regulatory framework for nuclear safety in the Republic of Korea. The team identified good practices and gave advice on areas for future improvements. The IAEA has conveyed the team's main conclusions to the Government of Korea, while the final report will be submitted by the end of summer 2011. At the request of the Korean Government, the IAEA assembled a team of 16 senior regulatory experts from 14 nations to conduct the Integrated Regulatory Review Service (IRRS) mission involving the Korean Ministry for Education, Science and Technology (MEST) and the Korean Institute for Nuclear Safety (KINS). The mission is a peer-review based on the IAEA Safety Standards. ''This was the first IRRS mission organized after Japan's Fukushima Daiichi nuclear accident and it included a review of the regulatory implications of that event,' explains Denis Flory, IAEA Deputy Director General and Head of the Department of Nuclear Safety and Security. William Borchardt, Executive Director of Operations from the US Nuclear Regulatory Commission and Team Leader of this mission commended the Korean authorities for their openness and commitment to sharing their experience with the world's nuclear safety community. ''IRRS missions such as the one that was just concluded here in the Republic of Korea are crucial to the enhancement of nuclear safety worldwide,'' he said. The IRRS team reviewed Korea's current regulatory framework while acknowledging the fact that the country's Government has already decided to establish, as of October 2011, a new independent regulatory body to be called Nuclear Safety Commission (NSC). As a consequence, KINS role will be as a regulatory expert organization reporting to the NSC, while MEST's role will be restricted to promoting the utilization of nuclear energy. The IRRS team identified particular strengths in the Korean regulatory system

  15. Regulatory dendritic cells in autoimmunity: A comprehensive review.

    Science.gov (United States)

    Liu, Juan; Cao, Xuetao

    2015-09-01

    Dendritic cells (DCs) are professional antigen-presenting cells (APC) with significant phenotypic heterogeneity and functional plasticity. DCs play crucial roles in initiating effective adaptive immune responses for elimination of invading pathogens and also in inducing immune tolerance toward harmless components to maintain immune homeostasis. The regulatory capacity of DCs depends on their immature state and distinct subsets, yet not restricted to the immature state and one specialized subset. The tolerogenicity of DC is controlled by a complex network of environmental signals and cellular intrinsic mechanisms. Regulatory DCs play an important role in the maintenance of immunological tolerance via the induction of T cell unresponsiveness or apoptosis, and generation of regulatory T cells. DCs play essential roles in driving autoimmunity via promoting the activation of effector T cells such as T helper 1 and T helper 17 cells, and/or suppressing the generation of regulatory T cells. Besides, a breakdown of DCs-mediated tolerance due to abnormal environmental signals or breakdown of intrinsic regulatory mechanisms is closely linked with the pathogenesis of autoimmune diseases. Novel immunotherapy taking advantage of the tolerogenic potential of regulatory DCs is being developed for treatment of autoimmune diseases. In this review, we will describe the current understanding on the generation of regulatory DC and the role of regulatory DCs in promoting tolerogenic immune responses and suppressing autoimmune responses. The emerging roles of DCs dysfunction in the pathogenesis of autoimmune diseases and the potential application of regulatory DCs in the treatment of autoimmune diseases will also be discussed. Copyright © 2015 Elsevier Ltd. All rights reserved.

  16. IAEA Mission Concludes Peer Review of UK's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2013-01-01

    Full text: Senior international nuclear safety and radiation protection experts today concluded a ten-day International Atomic Energy Agency (IAEA) mission to review the regulatory framework for nuclear and radiation safety in the United Kingdom (UK). The Integrated Regulatory Review Service (IRRS) mission team said in its preliminary findings that the UK had made considerable progress since reviews in 2006 and 2009. It also identified good practices in the country's nuclear regulatory system. In addition to following up previous missions, a key objective was to review the effectiveness of the role of the Office of Nuclear Regulation (ONR), the UK's nuclear regulator, in ensuring the safety of radioactive waste management and decommissioning, occupational radiation protection, and public and environmental exposures, including emergency planning and response. The mission also considered the response of the UK's regulatory regime to the implications of the Fukushima Daichi accident had been timely and effective. Recommendations and suggestions were made to the ONR and the Government aimed at strengthening the effectiveness of the country's regulatory framework and functions in line with IAEA Safety Standards, the control of radioactive discharges and environmental monitoring. 'The staff of ONR is clearly dedicated to their mission to secure the protection of people and society from the hazards of the nuclear industry. I am confident that ONR will use the results of this mission to further enhance their regulatory programs', said Bill Borchardt, mission leader and former Executive Director of the United States Nuclear Regulatory Commission (NRC). 'The staff were open and cooperative in their discussions; they provided the fullest practicable assistance, and accepted advice from the Team for continuous improvement in their regulatory work'. ONR's Chief Executive, John Jenkins, said that the full report of the IRRS mission will enhance regulatory effectiveness in the UK

  17. Safety Experts Complete IAEA Nuclear Regulatory Review of the United States

    International Nuclear Information System (INIS)

    2010-01-01

    Full text: An international team of senior nuclear safety experts today completed a two-week International Atomic Energy Agency (IAEA) review of the governmental and regulatory framework for nuclear safety in the United States. The team identified good practices within the U.S. system and offered suggestions for ways the U.S. Nuclear Regulatory Commission (NRC) could improve. The IAEA has conveyed the team's main conclusions to the NRC, and a final report will be submitted to the NRC in about two months. At the request of the United States, the IAEA assembled a team of 19 international experts to conduct an Integrated Regulatory Review Service (IRRS) mission. This mission was a peer review based on the IAEA Safety Standards. It was not an inspection, nor an audit. The experts came from 14 different countries: Canada, China, the Czech Republic, Finland, France, Italy, Japan, Mexico, the Republic of Korea, Slovenia, Spain, Sweden, Switzerland, and the United Kingdom. Team leader Jukka Laaksonen of Finland said: ''We found a comprehensive, consistent, and mature regulatory system run by the NRC, which has a strong drive for continuous improvement.' The scope of the mission included the U.S. regulatory framework and the regulation of the nuclear plant operation. The mission was conducted from 18 to 29 October, mainly at NRC headquarters outside of Washington, D.C. To study U.S. regulatory activities, the mission conducted a series of interviews and discussions with NRC staff and other organizations to help assess the effectiveness of the regulatory system. In addition, the team observed regulatory activities at two operating nuclear power reactors and an emergency preparedness exercise. The IAEA's IRRS coordinator Gustavo Caruso said, ''This mission represents a milestone for the IRRS program because the U.S. regulatory system is the largest in the world and many nations look to it. The IRRS is a useful tool that allows host nations to gain guidance from experienced

  18. 77 FR 59567 - Retrospective Regulatory Review Under E.O. 13563

    Science.gov (United States)

    2012-09-28

    ... #0;notices is to give interested persons an opportunity to participate in #0;the rule making prior to... Immigration Review 8 CFR Parts 1003, 1103, 1208, 1211, 1212, 1215, 1216, 1235 [EOIR No. 178] RIN 1125-AA71 Retrospective Regulatory Review Under E.O. 13563 AGENCY: Executive Office for Immigration Review, Department of...

  19. NRC review of passive reactor design certification testing programs: Overview, progress, and regulatory perspective

    Energy Technology Data Exchange (ETDEWEB)

    Levin, A.E.

    1995-09-01

    New reactor designs, employing passive safety systems, are currently under development by reactor vendors for certification under the U.S. Nuclear Regulatory Commission`s (NRC`s) design certification rule. The vendors have established testing programs to support the certification of the passive designs, to meet regulatory requirements for demonstration of passive safety system performance. The NRC has, therefore, developed a process for the review of the vendors` testing programs and for incorporation of the results of those reviews into the safety evaluations for the passive plants. This paper discusses progress in the test program reviews, and also addresses unique regulatory aspects of those reviews.

  20. Nuclear Experts Complete IAEA Follow-up Review of German Regulatory System

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: Nuclear safety experts concluded a seven-day mission to review the German Regulatory System, conducted from 4-10 September in Bonn, Stuttgart and Berlin. At the request of the Government of the Federal Republic of Germany, the International Atomic Energy Agency assembled a peer-review team of six high-level regulatory experts from six nations (Finland, France, the Netherlands, Switzerland, the UK, the US and three IAEA senior staff members) to conduct a follow-up assessment of an Integrated Regulatory Review Service (IRRS) mission conducted in 2008. This follow-up IRRS mission examined the progress in acting upon the recommendations and suggestions made during the 2008 IRRS mission and reviewed the areas of significant regulatory changes since that review at both the Federal Ministry of Environment, Nature Conservation and Nuclear Safety (BMU) and the Ministry of Environment of the federal state of Baden-Wurttemberg (UM BW). The first mission reviewed Germany's regulatory framework against IAEA Safety Standards and fostered the exchange of information and experience on safety regulation. This is a peer review based on IAEA Standards. It is not an inspection, nor an audit. The scope of the mission was limited to the safety regulation of nuclear power plants. IRRS team leader, Mr. McCree, of the US Nuclear Safety Commission (USNRC), said, ''This was an important IRRS mission, particularly given the recent Fukushima Daiichi Nuclear Power Plant accident and the related insights which underscore the importance of having an independent, credible nuclear safety regulator.'' ''The IRRS team identified several strengths of the German nuclear safety regulators, including the prompt and coordinated incident response activities of BMU and UM BW to the Fukushima accident. Some suggestions were also made to further strengthen nuclear safety regulations concerning the future work of BMU,'' he said. The review team found that important progress has been made toward

  1. Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice.

    Science.gov (United States)

    McCarty, Lynn S; Borgert, Christopher J; Mihaich, Ellen M

    2012-07-01

    There is an ongoing discussion on the provenance of toxicity testing data regarding how best to ensure its validity and credibility. A central argument is whether journal peer-review procedures are superior to Good Laboratory Practice (GLP) standards employed for compliance with regulatory mandates. We sought to evaluate the rationale for regulatory decision making based on peer-review procedures versus GLP standards. We examined pertinent published literature regarding how scientific data quality and validity are evaluated for peer review, GLP compliance, and development of regulations. Some contend that peer review is a coherent, consistent evaluative procedure providing quality control for experimental data generation, analysis, and reporting sufficient to reliably establish relative merit, whereas GLP is seen as merely a tracking process designed to thwart investigator corruption. This view is not supported by published analyses pointing to subjectivity and variability in peer-review processes. Although GLP is not designed to establish relative merit, it is an internationally accepted quality assurance, quality control method for documenting experimental conduct and data. Neither process is completely sufficient for establishing relative scientific soundness. However, changes occurring both in peer-review processes and in regulatory guidance resulting in clearer, more transparent communication of scientific information point to an emerging convergence in ensuring information quality. The solution to determining relative merit lies in developing a well-documented, generally accepted weight-of-evidence scheme to evaluate both peer-reviewed and GLP information used in regulatory decision making where both merit and specific relevance inform the process.

  2. International nuclear safety experts complete IAEA peer review of German regulatory system

    International Nuclear Information System (INIS)

    2008-01-01

    Full text: An international expert team has today completed a two-week IAEA review of Germany's nuclear regulatory system. The team identified good practices within the system and gave advice on some areas for further improvement. The IAEA has conveyed the initial findings to German authorities but the final report will be submitted within two months. At the request of the Government of the Federal Republic of Germany, the International Atomic Energy Agency (IAEA) assembled a team of 14 experts to conduct an Integrated Regulatory Review Service (IRRS) mission. This is a peer review based on IAEA Standards. It is not an inspection, nor an audit. The scope of the mission was limited to the safety regulation of nuclear power plants. Experts from Canada, the Czech Republic, Finland, France, Japan, the Netherlands, Republic of Korea, Spain, Switzerland, the UK, the US and from the IAEA took part in the mission, which was conducted from 7 to 19 September in Bonn, Stuttgart and Berlin. The main basis for the review was a well-prepared self-assessment made by the Federal Ministry of Environment, Nature Conservation and Nuclear Safety (BMU) and the Ministry of Environment of the federal state of Baden-Wuerttemberg (UM BW). 'The team members were impressed by the extensive preparation and dedication of the staff both at BMU and UM BW to excellence in nuclear safety,' said Mike Weightman, IRRS Team Leader and Chief Inspector of the UK nuclear regulatory body, the Nuclear Directorate of the Health and Safety Executive. 'We hope the IRRS mission will facilitate further improvements in the safety regulation of nuclear power in Germany and throughout the world.' 'Germany's invitation to undergo such a detailed review is a clear demonstration of its openness and commitment to continuously improve nuclear safety regulation,' said Philippe Jamet, Director of the IAEA's Nuclear Installation Safety Division. Among the particular strengths of BMU and UM BW associated with their

  3. 77 FR 26018 - Determination of Regulatory Review Period for Purposes of Patent Extension; Victoza

    Science.gov (United States)

    2012-05-02

    ... exercise to improve glycemic control in adults with type 2 diabetes mellitus. Subsequent to this approval...] Determination of Regulatory Review Period for Purposes of Patent Extension; Victoza AGENCY: Food and Drug... regulatory review period for Victoza and is publishing this notice of that determination as required by law...

  4. The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System.

    Science.gov (United States)

    Keyter, Andrea; Gouws, Joey; Salek, Sam; Walker, Stuart

    2018-01-01

    The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, transparency, timeliness, and predictability in the review process; and to provide recommendations for enhanced regulatory practices. A questionnaire was completed by the Medicines Control Council (MCC) to describe the organization of the authority, record key milestones and timelines in the review process and to identify good review practices (GRevPs). Currently, the MCC conducts a full assessment of quality, efficacy, and safety data in the review of all applications. The overall regulatory median approval time decreased by 14% in 2017 (1411 calendar days) compared with that of 2016, despite the 27% increase in the number of applications. However, the MCC has no target for overall approval time of new active substance applications and no targets for key review milestones. Guidelines, standard operating procedures, and review templates are in place, while the formal implementation of GRevPs and the application of an electronic document management system are planned for the near future. As the MCC transitions to the newly established South Africa Health Products Regulatory Authority, it would be crucial for the authority to recognize the opportunities for an enhanced regulatory review and should consider models such as abridged assessment, which encompass elements of risk stratification and reliance. It is hoped that resource constraints may then be alleviated and capacity developed to meet target timelines.

  5. Instruments Measuring Integrated Care: A Systematic Review of Measurement Properties.

    Science.gov (United States)

    Bautista, Mary Ann C; Nurjono, Milawaty; Lim, Yee Wei; Dessers, Ezra; Vrijhoef, Hubertus Jm

    2016-12-01

    Policy Points: Investigations on systematic methodologies for measuring integrated care should coincide with the growing interest in this field of research. A systematic review of instruments provides insights into integrated care measurement, including setting the research agenda for validating available instruments and informing the decision to develop new ones. This study is the first systematic review of instruments measuring integrated care with an evidence synthesis of the measurement properties. We found 209 index instruments measuring different constructs related to integrated care; the strength of evidence on the adequacy of the majority of their measurement properties remained largely unassessed. Integrated care is an important strategy for increasing health system performance. Despite its growing significance, detailed evidence on the measurement properties of integrated care instruments remains vague and limited. Our systematic review aims to provide evidence on the state of the art in measuring integrated care. Our comprehensive systematic review framework builds on the Rainbow Model for Integrated Care (RMIC). We searched MEDLINE/PubMed for published articles on the measurement properties of instruments measuring integrated care and identified eligible articles using a standard set of selection criteria. We assessed the methodological quality of every validation study reported using the COSMIN checklist and extracted data on study and instrument characteristics. We also evaluated the measurement properties of each examined instrument per validation study and provided a best evidence synthesis on the adequacy of measurement properties of the index instruments. From the 300 eligible articles, we assessed the methodological quality of 379 validation studies from which we identified 209 index instruments measuring integrated care constructs. The majority of studies reported on instruments measuring constructs related to care integration (33%) and patient

  6. Instruments Measuring Integrated Care: A Systematic Review of Measurement Properties

    Science.gov (United States)

    BAUTISTA, MARY ANN C.; NURJONO, MILAWATY; DESSERS, EZRA; VRIJHOEF, HUBERTUS JM

    2016-01-01

    Policy Points: Investigations on systematic methodologies for measuring integrated care should coincide with the growing interest in this field of research.A systematic review of instruments provides insights into integrated care measurement, including setting the research agenda for validating available instruments and informing the decision to develop new ones.This study is the first systematic review of instruments measuring integrated care with an evidence synthesis of the measurement properties.We found 209 index instruments measuring different constructs related to integrated care; the strength of evidence on the adequacy of the majority of their measurement properties remained largely unassessed. Context Integrated care is an important strategy for increasing health system performance. Despite its growing significance, detailed evidence on the measurement properties of integrated care instruments remains vague and limited. Our systematic review aims to provide evidence on the state of the art in measuring integrated care. Methods Our comprehensive systematic review framework builds on the Rainbow Model for Integrated Care (RMIC). We searched MEDLINE/PubMed for published articles on the measurement properties of instruments measuring integrated care and identified eligible articles using a standard set of selection criteria. We assessed the methodological quality of every validation study reported using the COSMIN checklist and extracted data on study and instrument characteristics. We also evaluated the measurement properties of each examined instrument per validation study and provided a best evidence synthesis on the adequacy of measurement properties of the index instruments. Findings From the 300 eligible articles, we assessed the methodological quality of 379 validation studies from which we identified 209 index instruments measuring integrated care constructs. The majority of studies reported on instruments measuring constructs related to care

  7. A review of instruments to measure interprofessional team-based primary care.

    Science.gov (United States)

    Shoemaker, Sarah J; Parchman, Michael L; Fuda, Kathleen Kerwin; Schaefer, Judith; Levin, Jessica; Hunt, Meaghan; Ricciardi, Richard

    2016-07-01

    Interprofessional team-based care is increasingly regarded as an important feature of delivery systems redesigned to provide more efficient and higher quality care, including primary care. Measurement of the functioning of such teams might enable improvement of team effectiveness and could facilitate research on team-based primary care. Our aims were to develop a conceptual framework of high-functioning primary care teams to identify and review instruments that measure the constructs identified in the framework, and to create a searchable, web-based atlas of such instruments (available at: http://primarycaremeasures.ahrq.gov/team-based-care/ ). Our conceptual framework was developed from existing frameworks, the teamwork literature, and expert input. The framework is based on an Input-Mediator-Output model and includes 12 constructs to which we mapped both instruments as a whole, and individual instrument items. Instruments were also reviewed for relevance to measuring team-based care, and characterized. Instruments were identified from peer-reviewed and grey literature, measure databases, and expert input. From nearly 200 instruments initially identified, we found 48 to be relevant to measuring team-based primary care. The majority of instruments were surveys (n = 44), and the remainder (n = 4) were observational checklists. Most instruments had been developed/tested in healthcare settings (n = 30) and addressed multiple constructs, most commonly communication (n = 42), heedful interrelating (n = 42), respectful interactions (n = 40), and shared explicit goals (n = 37). The majority of instruments had some reliability testing (n = 39) and over half included validity testing (n = 29). Currently available instruments offer promise to researchers and practitioners to assess teams' performance, but additional work is needed to adapt these instruments for primary care settings.

  8. A risk-based review of Instrument Air systems at nuclear power plants

    International Nuclear Information System (INIS)

    DeMoss, G.; Lofgren, E.; Rothleder, B.; Villeran, M.; Ruger, C.

    1990-01-01

    The broad objective of this analysis was to provide risk-based information to help focus regulatory actions related to Instrument Air (IA) systems at operating nuclear power plants. We first created an extensive data base of summarized and characterized IA-related events that gave a qualitative indication of the nature and severity of these events. Additionally, this data base was used to calculate the frequencies of certain events, which were used in the risk analysis. The risk analysis consisted of reviewing published PRAs and NRC Accident Sequence Precursor reports for IA-initiated accident sequences, IA interactions with frontline systems, and IA-related risk significant events. Sensitivity calculations were performed when possible. Generically, IA was found to contribute less to total risk than many safety systems; however, specific design weaknesses in safety systems, non-safety systems, and the IA system were found to be significant in risk. 22 refs., 13 figs., 24 tabs

  9. [Regulatory science: modern trends in science and education for pharmaceutical products].

    Science.gov (United States)

    Beregovykh, V V; Piatigorskaia, N V; Aladysheva, Zh I

    2012-01-01

    This article reviews modern trends in development of new instruments, standards and approaches to drugs safety, efficacy and quality assessment in USA and EU that can be called by unique term--"regulatory science" which is a new concept for Russian Federation. New education programs (curricula) developed by USA and EU universities within last 3 years are reviewed. These programs were designed in order to build workforce capable to utilize science approach for drug regulation. The principal mechanisms for financing research in regulatory science used by Food and Drug Administration are analyzed. There are no such science and relevant researches in Russian Federation despite the high demand as well as needs for the system for higher education and life-long learning education of specialists for regulatory affairs (or compliance).

  10. Safety experts complete second IAEA regulatory review of UK nuclear regulator

    International Nuclear Information System (INIS)

    2009-01-01

    Full text: Nuclear safety experts today concluded a 10-day mission to peer-review the UK Nuclear Regulator: Health and Safety Executive (HSE), Nuclear Directorate (ND). At the request of the UK Government, the International Atomic Energy Agency assembled a team of ten high-level regulatory experts from eight nations to conduct the Integrated Regulatory Review Service (IRRS) mission. The mission was the second of three planned IRRS missions for the United Kingdom. The first was held in March 2006 to begin a process to assess the nation's readiness to regulate and license new reactor designs, considered as a result of the Energy Policy review initiated by the British Prime Minister and the Secretary of State for Trade and Industry (DTI) in 2005. The IRRS team leader Mr. William Borchardt, Executive Director of Operations from the US Nuclear Regulatory Commission, stated, ''The IAEA IRRS serves an important role in both benchmarking against its safety standards and in promoting dialogue between nuclear safety regulators from around the world.'' During the 2nd mission the IRRS the team reviewed HSE/ND progress since the first IRRS mission and recent regulatory developments, the regulation of operating power plants and fuel cycle facilities, the inspection and enforcement programme for nuclear power plants and fuel cycle facilities, and the emergency preparedness and response programme. The IAEA found that HSE/ND has made significant progress toward improving its effectiveness in regulating existing nuclear power plants and in preparing to license new nuclear reactors designs. Many of the findings identified in the 2006 report had been fully addressed and therefore could be considered closed, the others are being addressed in accordance with a comprehensive action plan. IRRS team members visited the Heysham 1 Nuclear Power Plant near Lancaster, the Sellafield site at Cumbria and the Strategic Control Centre at Hutton, and they met senior managers from HSE and a UK

  11. Regulatory perspective on digital instrumentation and control systems for future advanced nuclear power plants

    International Nuclear Information System (INIS)

    Chiramal, M.

    1993-01-01

    This paper deals with the question of using digital technology in instrumentation and control systems for modern nuclear power reactors. The general opinion in the industry and among NRC staff is that such technology provides the opportunity for enhanced safety and reliable reactor operations. The major concern is the safe application of this technology so as to avoid common mode or common cause failures in systems. There are great differences between digital and analog system components. SECY-91-292 identifies some general regulatory concerns with regard to digital systems. There is clearly a lack of adequate regulatory direction on the application of digital equipment at this time, but the issue is being addressed by the industry, outside experts, and NRC staff. NRC staff presents a position on the issue of defense-in-depth and diversity with regard to insuring plant safety. Independent manual controls and readouts must be available to allow safe shutdown and monitoring of the plant in the event of safety system failures

  12. Appetitive Pavlovian-instrumental Transfer: A review.

    Science.gov (United States)

    Cartoni, Emilio; Balleine, Bernard; Baldassarre, Gianluca

    2016-12-01

    Reward-related cues are an important part of our daily life as they often influence and guide our actions. This paper reviews one of the experimental paradigms used to study the effects of cues, the Pavlovian to Instrumental Transfer paradigm. In this paradigm, cues associated with rewards through Pavlovian conditioning alter motivation and choice of instrumental actions. The first transfer experiments date back to the 1940s, but only in the last decade has it been fully recognised that there are two types of transfer, specific and general. This paper presents a systematic review of both the neural substrates and the behavioral factors affecting both types of transfer. It also examines the recent application of the paradigm to study the effect of cues on human participants, both in normal and pathological conditions, and the interactions of transfer with drugs of abuse. Finally, the paper analyses the theoretical aspects of transfer to build an overall picture of the phenomenon, from early theories to recent hierarchical accounts. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  13. Regulatory aspects of control and instrumentation: role of SCCI and a case study

    International Nuclear Information System (INIS)

    Patil, R.K.; Suresh Babu, R.M.; Roy, D.A.; Shriwalkar, Varsha

    2017-01-01

    Standing Committee for Control, Instrumentation and Computer based Systems (SCCI) was constituted in the year 2001 as an expert committee under Operating Plant Safety Review Committee (OPSRC) of BARC Safety Council (BSC). The terms of reference of SCCI include: review C and I aspects of systems affecting safety of operating plants, suggest modifications/improvements, conduct periodic review/audit and advise OPSRC on C and I matters. In this paper we share our experience in the review of safety cases of computer-based systems, specifically, review of three systems that are part of Dhruva C and I upgradation

  14. Development of a Symptom-Based Patient-Reported Outcome Instrument for Functional Dyspepsia: A Preliminary Conceptual Model and an Evaluation of the Adequacy of Existing Instruments.

    Science.gov (United States)

    Taylor, Fiona; Reasner, David S; Carson, Robyn T; Deal, Linda S; Foley, Catherine; Iovin, Ramon; Lundy, J Jason; Pompilus, Farrah; Shields, Alan L; Silberg, Debra G

    2016-10-01

    The aim was to document, from the perspective of the empirical literature, the primary symptoms of functional dyspepsia (FD), evaluate the extent to which existing questionnaires target those symptoms, and, finally, identify any missing evidence that would impact the questionnaires' use in regulated clinical trials to assess treatment efficacy claims intended for product labeling. A literature review was conducted to identify the primary symptoms of FD and existing symptom-based FD patient-reported outcome (PRO) instruments. Following a database search, abstracts were screened and articles were retrieved for review. The primary symptoms of FD were organized into a conceptual model and the PRO instruments were evaluated for conceptual coverage as well as compared against evidentiary requirements presented in the FDA's PRO Guidance for Industry. Fifty-six articles and 16 instruments assessing FD symptoms were reviewed. Concepts listed in the Rome III criteria for FD (n = 7), those assessed by existing FD instruments (n = 34), and symptoms reported by patients in published qualitative research (n = 6) were summarized in the FD conceptual model. Except for vomiting, all of the identified symptoms from the published qualitative research reports were also specified in the Rome III criteria. Only three of the 16 instruments, the Dyspepsia Symptom Severity Index (DSSI), Nepean Dyspepsia Index (NDI), and Short-Form Nepean Dyspepsia Index (SF-NDI), measure all seven FD symptoms defined by the Rome III criteria. Among these three, each utilizes a 2-week recall period and 5-point Likert-type scale, and had evidence of patient involvement in development. Despite their coverage, when these instruments were evaluated in light of regulatory expectations, several issues jeopardized their potential qualification for substantiation of a labeling claim. No existing PRO instruments that measured all seven symptoms adhered to the regulatory principles necessary to support product

  15. Concept Teaching in Instrumental Music Education: A Literature Review

    Science.gov (United States)

    Tan, Leonard

    2017-01-01

    This article is a review of research literature on the teaching of concepts in instrumental music education. It is organized in four parts (a) the value of concept teaching in large instrumental ensembles, (b) time spent teaching concepts during rehearsals, (c) approaches to concept teaching, and (d) implications for music education. Research has…

  16. International nuclear safety experts conclude IAEA peer review of China's regulatory system

    International Nuclear Information System (INIS)

    2010-01-01

    Full text: An international team of senior experts on nuclear safety regulation today completed a two-week International Atomic Energy Agency (IAEA) review of the governmental and regulatory framework for nuclear safety in the People's Republic of China. The team identified good practices within the system and gave advice on areas for future improvements. The IAEA has conveyed the team's main conclusions to the Government of the People's Republic of China. The final report will be submitted to China by Autumn 2010. At the request of Chinese authorities, the IAEA assembled a team of 22 experts to conduct an Integrated Regulatory Review Service (IRRS) mission. This mission is a peer review based on the IAEA Safety Standards . It is not an inspection, nor an audit. The experts came from 15 different countries: Australia, Canada, the Czech Republic, Finland, France, Hungary, Japan, Pakistan, the Republic of Korea, Slovenia, South Africa, Sweden, the United Kingdom, Ukraine and the United States. Mike Weightman, the United Kingdom's Head of Nuclear Directorate, HSE and HM Chief Inspector of Nuclear Installations said: ''I was honoured and pleased to lead such a team of senior regulatory experts from around the world, and I was impressed by their commitment, experience and hard work to provide their best advice possible. We had very constructive interactions with the Chinese authority to maximize the beneficial impact of the mission.'' The scope of the mission included the regulation of nuclear and radiation safety of the facilities and activities regulated by the Ministry of Environmental Protection (MEP) National Nuclear Safety Administration (NNSA). The mission was conducted from 18 to 30 July, mainly in Beijing. To observe Chinese regulatory activities, the IRRS team visited several nuclear facilities, including a nuclear power plant, a manufacturer of safety components for nuclear power plants, a research reactor, a fuel cycle facility, a waste management facility

  17. IAEA Team Concludes Peer Review of Greece's Regulatory Framework for Radiation Safety

    International Nuclear Information System (INIS)

    2012-01-01

    Full text: An international team of senior nuclear safety and radiation protection experts yesterday concluded an 11-day mission to review the regulatory framework for nuclear and radiation safety in Greece. The Integrated Regulatory Review Service (IRRS) mission, which was conducted at the request of the Government of the Hellenic Republic, noted good practices in the country's nuclear regulatory system and also identified issues for improvement for the Greek Atomic Energy Commission (GAEC) and the Greek competent authorities. These are aimed at strengthening the effectiveness of the country's regulatory framework and functions in line with IAEA Safety Standards. ''The IRRS team enjoyed excellent cooperation from the GAEC throughout its mission,'' said Tom Ryan, mission leader and Director of Regulations and Information Management at the Radiological Protection Institute of Ireland. ''The GAEC staff were very open and candid in their discussions and provided the fullest practicable assistance.'' The main observations of the IRRS Review team included: While the Greek Government's commitment to safety is being demonstrated through its actions, the development of a comprehensive national policy and strategy expressed in a consolidated statement would provide a valuable framework and guidance for future actions in terms of safety; and GAEC has effective independence. The Greek government has ensured that GAEC is effectively independent in its safety-related decision-making and that it has functional separation from entities having responsibility or interests that could unduly influence its decision making. Strengths and good practices identified by the IRRS team included: Greece actively participates in the global safety regime including all relevant safety conventions; The nation's radiation monitoring system for the detection of illicit trafficking contributes significantly to identifying potential radiation emergencies due to events within or outside the country

  18. Integrated Regulatory Review Service (IRRS) Guidelines for the Preparation and Conduct of IRRS Missions

    International Nuclear Information System (INIS)

    2013-01-01

    The IAEA Integrated Regulatory Review Service (IRRS) was established to strengthen and enhance the effectiveness of national regulatory infrastructure for nuclear safety, radiation safety, radioactive waste and transport safety, and the security of radioactive sources, while recognizing the ultimate responsibility of each Member State to ensure safety in these areas. The IRRS process sets out to accomplish this expressed purpose through consideration of both technical and policy issues of a regulatory nature against IAEA safety standards and, where appropriate, good practice elsewhere. The regulatory review process directly draws upon the wide-ranging international experience and expertise of IRRS review team members. Peer exchange on technical and policy issues gives insight into the efficiency and effectiveness of the legal and governmental framework and regulatory infrastructure for safety. Through this process, opportunities for improvement are explored and potential improvement strategies identified which may be shared with other States. IRRS missions provide an opportunity for sharing regulatory experiences, harmonizing regulatory approaches among States, and creating mutual learning opportunities among regulators. IRRS discussions focus on issues arising from the State's self-assessment and the evaluation of technical areas and policy issues. The IAEA Fundamental Safety Principles (IAEA Safety Standards Series No. SF-1) provide the basis for IAEA safety standards and IAEA safety related programmes. In support of effective regulation, the IAEA has established safety standards in the area of the Governmental, Legal and Regulatory Framework for Safety (IAEA Safety Standards Series No. GSR Part 1). These safety standards form a core component of an IRRS review. Other requirements and guidance, such as The Management System for Facilities and Activities (IAEA Safety Standards Series No. GS-R-3) and Radiation Protection and Safety of Radiation Sources

  19. A Review on the Regulatory Strategy of Human Factors Engineering Consideration in Pakistan Nuclear Facilities

    Energy Technology Data Exchange (ETDEWEB)

    Sohail, Sabir [Korea Advanced Institute of Science and Technology, Daejeon (Korea, Republic of); Choi, Seong Nam [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2013-10-15

    In this paper, the legal and regulatory infrastructure available in Pakistan for HFE requirements is assessed, and the methodology for strengthening of legal infrastructure is presented. The regulatory strategy on evaluation of HFE consideration should provide reviewers with guidance on review process. Therefore, the suggested methodology is based on preparation of guidance documents such as checklist, working procedures, S and Gs etc.; incorporation of PRM elements in regulatory system; and finally the development of PRM implementation criteria. Altogether, the scheme provide the enhancement in regulatory infrastructure and also the effective and efficient review process. The Three Mile Island (TMI) accident brought the general consensus among the nuclear community on the integration of human factors engineering (HFE) principles in all phases of nuclear power. This notion has further strengthened after the recent Fukushima nuclear accident. Much effort has been put over to incorporate the lesson learned and continuous technical evolution on HFE to device different standards. The total of 174 ergonomics standards are alone identified by Dul et al. (2004) published by International Organization for Standardization (ISO) and the European Committee for Standardization (CEN) and number of standards and HFE guidelines (S and Gs) are also published by organizations like Institute for Electrical and Electronics Engineering (IEEE), International Electrotechnical Commission (IEC), International Atomic Energy Agency (IAEA), United States Nuclear Regulatory Commission (USNRC), etc. The ambition of effective review on HFE integration in nuclear facility might be accomplished through the development of methodology for systematic implementation of S and Gs. Such kind of methodology would also be beneficial for strengthening the regulatory framework and practices for countries new in the nuclear arena and with small scale nuclear program. The objective of paper is to review the

  20. Breastfeeding Self-efficacy: A Critical Review of Available Instruments

    Science.gov (United States)

    Tuthill, Emily L.; McGrath, Jacqueline M.; Graber, Melanie; Cusson, Regina M.; Young, Sera L.

    2016-01-01

    Increasing breastfeeding rates in the United States is a national priority. Yet, initiation and duration of breastfeeding remains below national targets. Breastfeeding self-efficacy has been shown to be a strong predictor of both breastfeeding initiation and duration and is therefore an important characteristic to be able to measure. However, there is currently a myriad of instruments for measuring breastfeeding self-efficacy, which makes selection of an appropriate instrument difficult. Thus, our aim was to identify, compare, and critically review available breastfeeding self-efficacy instruments. In a systematic review, 6 breastfeeding self-efficacy instruments were identified. The instruments’ purposes, theoretical framework, final scale development, and application in 5 most recent settings were analyzed. The 6 breastfeeding self-efficacy instruments apply a number of theoretical and conceptual frameworks in their development, with Bandura’s social cognitive theory being most common. Content, construct, and predictive validity were strong for most scales. Some, but not all, have been successfully adapted to novel settings. In sum, there are several measurements of breastfeeding self-efficacy that can and should be employed to better understand reasons for suboptimal breastfeeding rates and the effects of interventions on breastfeeding self-efficacy. Instrument selection should be based on domains of primary interest, time available, peripartum timing, and assessment of previous adaptations. Failure to apply appropriate measures in research may garner results that are inconclusive, inaccurate, or nonrepresentative of true study effects. PMID:26319113

  1. Institutional review board and regulatory solutions in the dental PBRN

    DEFF Research Database (Denmark)

    Gilbert, Gregg H; Qvist, Vibeke; Moore, Sheila D

    2010-01-01

    Effectively addressing regulatory and human participant protection issues with Institutional Review Boards (IRBs, or ethics committees) and grants administration entities is an important component of conducting research in large collaborative networks. A dental practice-based research network...

  2. Workshop on Regulatory Review and Safety Assessment Issues in Repository Licensing

    International Nuclear Information System (INIS)

    Wilmot, Roger D.

    2011-02-01

    The workshop described here was organised to address more general issues regarding regulatory review of SKB's safety assessment and overall review strategy. The objectives of the workshop were: - to learn from other programmes' experiences on planning and review of a license application for a nuclear waste repository, - to offer newly employed SSM staff an opportunity to learn more about selected safety assessment issues, and - to identify and document recommendations and ideas for SSM's further planning of the licensing review

  3. Nuclear Regulatory Commission's antitrust review process: an analysis of the impacts

    International Nuclear Information System (INIS)

    1981-06-01

    The Nuclear Regulatory Commission's (NRC) antitrust process is reviewed and its impacts to small systems and applicant systems are studied. This process takes the form of a description of the NRC's antitrust review process as implemented, a generic categorization of potential impacts and individual case-by-case studies of four different utilities

  4. Taking spiritual history in clinical practice: a systematic review of instruments.

    Science.gov (United States)

    Lucchetti, Giancarlo; Bassi, Rodrigo M; Lucchetti, Alessandra L Granero

    2013-01-01

    To facilitate the addressing of spirituality in clinical practice, several authors have created instruments for obtaining a spiritual history. However, in only a few studies have authors compared these instruments. The aim of this study was to compare the most commonly used instruments for taking a spiritual history in a clinical setting. A systematic review of spiritual history assessment was conducted in five stages: identification of instruments used in the literature (databases searching); relevant articles from title and initial abstract review; exclusion and Inclusion criteria; full text retrieval and final analysis of each instrument. A total of 2,641 articles were retrieved and after the analysis, 25 instruments were included. The authors independently evaluated each instrument on 16 different aspects. The instruments with the greatest scores in the final analysis were FICA, SPIRITual History, FAITH, HOPE, and the Royal College of Psychiatrists. Concerning all 25 instruments, 20 of 25 inquire about the influence of spirituality on a person's life and 17 address religious coping. Nevertheless, only four inquire about medical practices not allowed, six deal with terminal events, nine have mnemonics to facilitate their use, and five were validated. FICA, SPIRITual History, FAITH, HOPE, and Royal College of Psychiatrists scored higher in our analysis. The use of each instrument must be individualized, according to the professional reality, time available, patient profile, and settings. Copyright © 2013 Elsevier Inc. All rights reserved.

  5. International Expert Team Concludes IAEA Peer Review of Slovakia's Regulatory Framework for Nuclear Safety

    International Nuclear Information System (INIS)

    2012-01-01

    Full text: An international team of senior nuclear safety and radiation protection experts today concluded an 11-day mission to review the regulatory framework for nuclear safety in Slovakia. At the request of the Slovak Government, the IAEA assembled a team of 12 senior regulatory experts from 12 nations to conduct the Integrated Regulatory Review Service (IRRS) mission involving the Nuclear Regulatory Authority of the Slovak Republic (UJD SR). The international experts also met officials from the Public Health Authority of the Slovak Republic (UVZ SR) regarding the regulation of occupational radiation protection in nuclear facilities. The mission is a peer review based on the IAEA Safety Standards. Marta Ziakova, Chairperson of the Nuclear Regulatory Authority of Slovak Republic, declared that ''The IRRS mission has a great value for the future development and orientation of the UJD SR.'' ''Slovakia has established a regulatory framework for nuclear safety which is in line with international standards and practice,'' said Mission Team Leader Andrej Stritar, Director of the Slovenian Nuclear Safety Administration. The main observations of the IRRS Review team included: UJD SR operates with independence and transparency; UJD SR has developed and implemented a systematic training approach to meet its competence needs; and in response to the accident at TEPCO's Fukushima Daiichi Nuclear Power Station, UJD SR has reacted and communicated to interested parties, including the public. The good practices identified by the IRRS Review Team include: UJD SR has a comprehensive and well-formalized strategic approach to informing and consulting interested parties; UJD SR has developed and implemented a structured approach to training and developing its staff; and Detailed legal requirements provide a solid basis for on-site and off-site response in nuclear emergencies coordinated with local authorities. The IRRS Review team identified areas for further improvement and believes

  6. International Nuclear and Radiation Safety Experts Conclude IAEA Peer Review of Slovenia's Regulatory System

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: An international team of senior nuclear safety experts today concluded a 10-day mission to review the regulatory framework for nuclear and radiation safety in Slovenia. The team identified good practices and gave advice on areas for future improvements. The IAEA has conveyed the team's main conclusions to the Government of Slovenia and a final report will be submitted by the end of 2011. At the request of the Slovenian Government, the IAEA assembled a team of 10 senior regulatory experts from nine nations to conduct the Integrated Regulatory Review Service (IRRS) mission involving the Slovenian Nuclear Safety Administration (SNSA). The mission is a peer review based on the IAEA Safety Standards. Andrej Stritar, Director of Slovenian Nuclear Safety Administration, stressed ''how important it is for a small country like Slovenia to tightly follow international standards in the area of nuclear safety.'' He also expressed his gratitude to the IAEA, and the countries from which team members came, for their support and for their intensive work during the last ten days. Mission Team Leader Colin Patchett, Deputy Chief Inspector from the UK's Office for Nuclear Regulation commended ''the Slovenian authorities for their commitment to nuclear and radiation safety regulation and for sharing their experience.'' The IRRS team reviewed Slovenia's current regulatory framework and all SNSA-regulated facilities and activities, as well as the regulatory implications of the TEPCO Fukushima Daiichi accident. The IRRS team identified particular strengths in the Slovenian regulatory system, including: Through its legal framework, the Slovenian government has appointed SNSA to regulate its nuclear safety program and SNSA has in place an effective process for carrying out this responsibility; and Slovenia's response to the accident at the TEPCO Fukushima Daiichi power plant has been prompt and effective. Communications with the public, development of actions for improvement

  7. Development of safety and regulatory requirements for Korean next generation reactor - Development of human factors design review guidelines (II)

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jung Woon; Oh, In Suk; Lee, Hyun Chul; Cheon, Se Woo [Korea Atomic Energy Research Institute, Taejon (Korea)

    1999-02-01

    The objective of this study is to develop human factors engineering program review guidelines and alarm system review guidelines in order to resolve the two major technical issues: '25. Human Factors Engineering Program Review Model' and '26. Review Criteria for Human Factors Aspects of Advanced Controls and Instrumentation', which are related to the development of human factors safety regulation guides being performed by KINS. For the development of human factors program review guidelines, we made a Korean version of NUREG-0711 and added our comments by considering Korean regulatory situation and the characteristics of the KNGR design, and reviewing the reference documents of NURGE-0711. We also computerized the Korean version of NUREG-0711, additional comments, and selected portion of the reference documents for the developer of safety regulation guides at KINS to see the contents comparatively at a glance and use them easily. For the development of alarm system design review guidelines, we made a Korean version of NUREG/CR-6105, which was published by NRC in 1994 as a guideline document for the human factors review of alarm systems. Then we updated the guidelines by reviewing the literature related to alarm design that published after 1994. 12 refs., 11 figs., 2 tabs. (Author)

  8. Development of safety and regulatory requirements for Korean next generation reactor - Development of human factors design review guidelines (II)

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jung Woon; Oh, In Suk; Lee, Hyun Chul; Cheon, Se Woo [Korea Atomic Energy Research Institute, Taejon (Korea)

    1999-02-01

    The objective of this study is to develop human factors engineering program review guidelines and alarm system review guidelines in order to resolve the two major technical issues: '25. Human Factors Engineering Program Review Model' and '26. Review Criteria for Human Factors Aspects of Advanced Controls and Instrumentation', which are related to the development of human factors safety regulation guides being performed by KINS. For the development of human factors program review guidelines, we made a Korean version of NUREG-0711 and added our comments by considering Korean regulatory situation and the characteristics of the KNGR design, and reviewing the reference documents of NURGE-0711. We also computerized the Korean version of NUREG-0711, additional comments, and selected portion of the reference documents for the developer of safety regulation guides at KINS to see the contents comparatively at a glance and use them easily. For the development of alarm system design review guidelines, we made a Korean version of NUREG/CR-6105, which was published by NRC in 1994 as a guideline document for the human factors review of alarm systems. Then we updated the guidelines by reviewing the literature related to alarm design that published after 1994. 12 refs., 11 figs., 2 tabs. (Author)

  9. A systematic review of instruments that measure attitudes toward homosexual men.

    Science.gov (United States)

    Grey, Jeremy A; Robinson, Beatrice Bean E; Coleman, Eli; Bockting, Walter O

    2013-01-01

    Scientific interest in the measurement of homophobia and internalized homophobia has grown over the past 30 years, and new instruments and terms have emerged. To help researchers with the challenging task of identifying appropriate measures for studies in sexual-minority health, we reviewed measures of homophobia published in the academic literature from 1970 to 2012. Instruments that measured attitudes toward male homosexuals/homosexuality or measured homosexuals' internalized attitudes toward homosexuality were identified using measurement manuals and a systematic review. A total of 23 instruments met criteria for inclusion, and their features were summarized and compared. All 23 instruments met minimal criteria for adequate scale construction, including scale development, sampling, reliability, and evidence of validity. Validity evidence was diverse and was categorized as interaction with gay men, HIV/AIDS variables, mental health, and conservative religious or political beliefs. Homophobia was additionally correlated with authoritarianism and bias, gender ideology, gender differences, and reactions to homosexual stimuli. Internalized homophobia was validated by examining relationships with disclosing one's homosexuality and level of homosexual identity development. We hope this review will make the process of instrument selection more efficient by allowing researchers to easily locate, evaluate, and choose the proper measure based on their research question and population of interest.

  10. National legislative and regulatory activities

    International Nuclear Information System (INIS)

    2016-01-01

    This section treats of the following National legislative and regulatory activities: 1 - France: General legislation, regulations and instruments; Nuclear trade (including non-proliferation); International co-operation; 2 - India: Licensing and regulatory infrastructure; Liability and compensation; 3 - Ireland: Nuclear safety and radiological protection (including nuclear emergency planning); Transport of radioactive material; Nuclear trade (including non-proliferation); 4 - Lithuania: Licensing and regulatory infrastructure; Nuclear safety and radiological protection (including nuclear emergency planning); Radioactive waste management; 5 - Luxembourg: Nuclear safety and radiological protection (including nuclear emergency planning); 6 - Slovak Republic: International co-operation; General legislation, regulations and instruments; 7 - Spain: Radioactive materials (including physical protection); Radioactive waste management; 8 - United States: Licensing and regulatory infrastructure

  11. IAEA Mission Concludes Peer Review of Viet Nam's Radiation and Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2014-01-01

    Senior international nuclear safety and radiation protection experts today concluded a 10-day International Atomic Energy Agency (IAEA) mission to review how Viet Nam's regulatory framework for nuclear and radiation safety has incorporated recommendations and suggestions from an earlier review, conducted in 2009. The Integrated Regulatory Review Service (IRRS) follow-up mission, requested by the Viet Nam Agency for Radiation and Nuclear Safety (VARANS), also reviewed the development of the regulatory safety infrastructure to support Viet Nam's nuclear power programme. The eight-member team comprised senior regulatory experts from Canada, France, Pakistan, Slovenia, United Arab Emirates and the United States of America, as well as three IAEA staff members. The IRRS team said in its preliminary assessment that Viet Nam had made progress since 2009, but that some key recommendations still needed to be addressed. Particular strengths identified by the team included: The commitment of VARANS staff to develop legislation and regulations in the field of nuclear and radiation safety; VARANS' efforts to implement practices that are in line with IAEA Safety Standards and internationally recognized good practices; A willingness to receive feedback regarding the efforts to establish and implement a regulation programme; and Progress made in developing the regulatory framework to support the introduction of nuclear power. The team identified the following areas as high-priority steps to further strengthen radiation and nuclear safety in Viet Nam: The effective independence of the regulatory decision-making process needs to be urgently addressed; Additional resources are needed to regulate existing radiation facilities and activities, as well as the country's research reactor; Efforts to increase the capacity of VARANS to regulate the developing nuclear power programme should continue; The draft Master Plan for the Development of Nuclear Power Infrastructure should be finalized

  12. The Society for Implementation Research Collaboration Instrument Review Project: a methodology to promote rigorous evaluation.

    Science.gov (United States)

    Lewis, Cara C; Stanick, Cameo F; Martinez, Ruben G; Weiner, Bryan J; Kim, Mimi; Barwick, Melanie; Comtois, Katherine A

    2015-01-08

    Identification of psychometrically strong instruments for the field of implementation science is a high priority underscored in a recent National Institutes of Health working meeting (October 2013). Existing instrument reviews are limited in scope, methods, and findings. The Society for Implementation Research Collaboration Instrument Review Project's objectives address these limitations by identifying and applying a unique methodology to conduct a systematic and comprehensive review of quantitative instruments assessing constructs delineated in two of the field's most widely used frameworks, adopt a systematic search process (using standard search strings), and engage an international team of experts to assess the full range of psychometric criteria (reliability, construct and criterion validity). Although this work focuses on implementation of psychosocial interventions in mental health and health-care settings, the methodology and results will likely be useful across a broad spectrum of settings. This effort has culminated in a centralized online open-access repository of instruments depicting graphical head-to-head comparisons of their psychometric properties. This article describes the methodology and preliminary outcomes. The seven stages of the review, synthesis, and evaluation methodology include (1) setting the scope for the review, (2) identifying frameworks to organize and complete the review, (3) generating a search protocol for the literature review of constructs, (4) literature review of specific instruments, (5) development of an evidence-based assessment rating criteria, (6) data extraction and rating instrument quality by a task force of implementation experts to inform knowledge synthesis, and (7) the creation of a website repository. To date, this multi-faceted and collaborative search and synthesis methodology has identified over 420 instruments related to 34 constructs (total 48 including subconstructs) that are relevant to implementation

  13. Workshop on Regulatory Review and Safety Assessment Issues in Repository Licensing

    Energy Technology Data Exchange (ETDEWEB)

    Wilmot, Roger D. (Galson Sciences Limited (United Kingdom))

    2011-02-15

    The workshop described here was organised to address more general issues regarding regulatory review of SKB's safety assessment and overall review strategy. The objectives of the workshop were: - to learn from other programmes' experiences on planning and review of a license application for a nuclear waste repository, - to offer newly employed SSM staff an opportunity to learn more about selected safety assessment issues, and - to identify and document recommendations and ideas for SSM's further planning of the licensing review

  14. A Review of the LHC Beam Instrumentation

    CERN Document Server

    Fischer, Cl

    1998-01-01

    This is a review of the diagnostics presently considered for LHC running in and operation. The purpose of each instrument is given and, except for the pick-ups of the Beam Position Monitoring system w hich have their position already reserved, the optimal location and an estimate of the required length along the vacuum chamber are given.

  15. 76 FR 6094 - FAA Public Forum To Conduct Regulatory Review

    Science.gov (United States)

    2011-02-03

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Parts 27 and 29 FAA Public Forum To Conduct Regulatory Review AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of public meeting. SUMMARY: The FAA announces an informal meeting to discuss the FAA rotorcraft rules, 14...

  16. Instruments to assess self-care among healthy children: A systematic review of measurement properties.

    Science.gov (United States)

    Urpí-Fernández, Ana-María; Zabaleta-Del-Olmo, Edurne; Montes-Hidalgo, Javier; Tomás-Sábado, Joaquín; Roldán-Merino, Juan-Francisco; Lluch-Canut, María-Teresa

    2017-12-01

    To identify, critically appraise and summarize the measurement properties of instruments to assess self-care in healthy children. Assessing self-care is a proper consideration for nursing practice and nursing research. No systematic review summarizes instruments of measurement validated in healthy children. Psychometric review in accordance with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) panel. MEDLINE, CINAHL, PsycINFO, Web of Science and Open Grey were searched from their inception to December 2016. Validation studies with a healthy child population were included. Search was not restricted by language. Two reviewers independently assessed the methodological quality of included studies using the COSMIN checklist. Eleven studies were included in the review assessing the measurement properties of ten instruments. There was a maximum of two studies per instrument. None of the studies evaluated the properties of test-retest reliability, measurement error, criterion validity and responsiveness. Internal consistency and structural validity were rated as "excellent" or "good" in four studies. Four studies were rated as "excellent" in content validity. Cross-cultural validity was rated as "poor" in the two studies (three instruments) which cultural adaptation was carried out. The evidence available does not allow firm conclusions about the instruments identified in terms of reliability and validity. Future research should focus on generate evidence about a wider range of measurement properties of these instruments using a rigorous methodology, as well as instrument testing on different countries and child population. © 2017 John Wiley & Sons Ltd.

  17. Review of SFR Design Safety using Preliminary Regulatory PSA Model

    International Nuclear Information System (INIS)

    Na, Hyun Ju; Lee, Yong Suk; Shin, Andong; Suh, Nam Duk

    2013-01-01

    The major objective of this research is to develop a risk model for regulatory verification of the SFR design, and thereby, make sure that the SFR design is adequate from a risk perspective. In this paper, the development result of preliminary regulatory PSA model of SFR is discussed. In this paper, development and quantification result of preliminary regulatory PSA model of SFR is discussed. It was confirmed that the importance PDRC and ADRC dampers is significant as stated in the result of KAERI PSA model. However, the importance can be changed significantly depending on assumption of CCCG and CCF factor of PDRC and ADRC dampers. SFR (sodium-cooled fast reactor) which is Gen-IV nuclear energy system, is designed to accord with the concept of stability, sustainability and proliferation resistance. KALIMER-600, which is under development in Korea, includes passive safety systems (e. g. passive reactor shutdown, passive residual heat removal, and etc.) as well as active safety systems. Risk analysis from a regulatory perspective is needed to support the regulatory body in its safety and licensing review for SFR (KALIMER-600). Safety issues should be identified in the early design phase in order to prevent the unexpected cost increase and delay of the SFR licensing schedule that may be caused otherwise

  18. Preparation of safety regulatory requirements for new technology like digital system

    International Nuclear Information System (INIS)

    2012-01-01

    The current regulatory requirements on digital instrumentation and control system have been reviewed by JNES, considering international trend discussed in DICWG of MDEP. MDEP DICWG held in OECD/NEA gives the opportunity to identify the convergence of applicable standards. The working group's activities include: identifying and prioritising the member countries' challenges, practices, and needs regarding standards and regulatory guidance on digital instrumentation and control; identifying areas of importance and needs for convergence of existing standards and guidance or development of new standards; sharing of information; and identifying common positions among the member countries for areas of particular importance and need. The DICWG drafted common positions on specific issues which are based on the existing standards, national regulatory guidance, best practices, and group inputs using an agreed process and framework. The following two general common positions are discussed and to be issued in this fiscal year. Verification and Validation throughout the life cycle of safety systems using digital computers. The Impact of Cyber Security Features on Digital I and C Safety Systems. (author)

  19. 76 FR 47527 - Retrospective Regulatory Review Under E.O. 13563

    Science.gov (United States)

    2011-08-05

    ... DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Chapter VII [Docket No. 110711380-1379-01] RIN 0694-XA37 Retrospective Regulatory Review Under E.O. 13563 AGENCY: Bureau of Industry and Security, Commerce. ACTION: Notice of inquiry. SUMMARY: The Bureau of Industry and Security (BIS...

  20. Reliability and validity of instruments measuring job satisfaction - a systematic review

    NARCIS (Netherlands)

    van Saane, N.; Sluiter, J. K.; Verbeek, J. H. A. M.; Frings-Dresen, M. H. W.

    2003-01-01

    Background Although job satisfaction research has been carried out for decades, no recent overview of job satisfaction instruments and their quality is available. Aim The aim of this systematic review is to select job satisfaction instruments of adequate reliability and validity for use as

  1. Systematic review of measurement properties of self-reported instruments for evaluating self-care in adults.

    Science.gov (United States)

    Matarese, Maria; Lommi, Marzia; De Marinis, Maria Grazia

    2017-06-01

    The aims of this study were as follows: to identify instruments developed to assess self-care in healthy adults; to determine the theory on which they were based; their validity and reliability properties and to synthesize the evidence on their measurement properties. Many instruments have been developed to assess self-care in many different populations and conditions. Clinicians and researchers should select the most appropriate self-care instrument based on the knowledge of their measurement properties. Systematic review of measurement instruments according to the protocol recommended by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) panel. PubMed, Embase, PsycINFO, Scopus and CINAHL databases were searched from inception to December 2015. Studies testing measurement properties of self-report instruments assessing self-care in healthy adults, published in the English language and in peer review journals were selected. Two reviewers independently appraised the methodological quality of the studies with the COSMIN checklist and the quality of results using specific quality criteria. Twenty-six articles were included in the review testing the measurement properties of nine instruments. Seven instruments were based on Orem's Self-care theory. Not all the measurement properties were evaluated for the identified instruments. No self-care instrument showed strong evidence supporting the evaluated measurement properties. Despite the development of several instruments to assess self-care in the adult population, no instrument can be fully recommended to clinical nurses and researchers. Further studies of high methodological quality are needed to confirm the measurement properties of these instruments. © 2016 John Wiley & Sons Ltd.

  2. Observation of nurse-patient interaction in oncology: review of assessment instruments.

    NARCIS (Netherlands)

    Caris-Verhallen, W.; Timmermans, L.; Dulmen, S. van

    2004-01-01

    The aim of this review is to identify assessment instruments that can be used for analyzing sequences and can be applied to research into nurse-patient communication in cancer care. A systematic search of the literature revealed a variety of methods and instruments applicable to studies recording

  3. 78 FR 23199 - NASA FAR Supplement Regulatory Review No. 1

    Science.gov (United States)

    2013-04-18

    ... 2700-AE01 NASA FAR Supplement Regulatory Review No. 1 AGENCY: National Aeronautics and Space Administration. ACTION: Proposed rule. SUMMARY: NASA is updating the NASA FAR Supplement (NFS) with the goal of... existing regulations. The revisions to this rule are part of NASA's retrospective plan under EO 13563...

  4. Risk Assessment Review Group report to the U.S. Nuclear Regulatory Commission

    International Nuclear Information System (INIS)

    Lewis, H.W.; Budnitz, R.J.; Kouts, H.J.C.; Loewenstein, W.B.; Rowe, W.D.; von Hippel, F.; Zachariasen, F.

    1978-09-01

    The Risk Assessment Review Group was organized by the U.S. Nuclear Regulatory Commission on July 1, 1977, with four elements to its charter: clarify the achievements and limitations of WASH-1400, the ''Rasmussen Report''; assess the peer comments thereon, and responses to those comments; study the present state of such risk assessment methodology; and recommend to the Commission how (and whether) such methodology can be used in the regulatory and licensing process. Areas of study include: risk assessment methodologies; statistical issues; completeness; the data base; and the WASH-1400 assessment of the damage to human health from radiation after a postulated accident. Specific items discussed include: Browns Ferry; common cause failure; human factors; format and scrutability; the peer review process; earthquakes; risk perception; allegations by UCS concerning WASH-1400 treatment of quality assurance and quality control; current role of probabilistic methods in the regulatory process; acts of violence; ATWS; influence of design defects in quality assurance failures; and calculation of population doses from given releases of radionuclides

  5. International Expert Team Concludes IAEA Peer Review of Poland's Regulatory Framework for Nuclear and Radiation Safety

    International Nuclear Information System (INIS)

    2013-01-01

    Full text: International safety experts last week concluded a two-week International Atomic Energy Agency (IAEA) mission to review the regulatory framework for nuclear and radiation safety in Poland. In its preliminary report, the Integrated Regulatory Review Service (IRRS) mission team found that Poland's nuclear regulator, Panstwowa Agencja Atomistyki (PAA), has a clear commitment to safety, a high level of transparency, competent staff and leadership, and a good recognition of challenges ahead related to Poland's efforts to develop nuclear power. ''Poland's regulatory framework and the work of PAA give high confidence of strong radiation protection for the Polish people. Further, there has been significant progress in the development of Poland's regulatory framework in preparation for the challenge of regulating nuclear power,'' said team leader Robert Lewis, a senior executive in the US Nuclear Regulatory Commission. The mission was conducted at the request of the Government of Poland from 15-25 April. The team was made up of 11 regulatory experts from Belgium, the Czech Republic, Finland, France, the Republic of Korea, Slovakia, Slovenia, Sweden, the United Arab Emirates, the United Kingdom and the United States, as well as five IAEA staff members. The IRRS review team was very thorough in its review, and we welcome its advice on how to continue to improve our programmes to protect people and the environment , said Janusz Wlodarski, President of PAA. The team interviewed members of PAA and officials from various ministries, as well as key players in the Polish safety framework. Such IRRS missions are peer reviews based on IAEA Safety Standards, not inspections or audits. Among its main observations the IRRS review team identified the following good practices: Applying the considerable experience of PAA's senior management to regulatory issues; The introduction of changes to Poland's laws and regulations following broad public consultation at an early stage in

  6. IAEA Team Concludes Peer Review of Sweden's Nuclear Regulatory Framework, 17 February 2012, Stockholm, Sweden

    International Nuclear Information System (INIS)

    2012-01-01

    Full text: An international team of senior nuclear safety and radiation protection experts today concluded a 12-day mission to review the regulatory framework for nuclear and radiation safety in Sweden. The Integrated Regulatory Review Service (IRRS) mission, which was conducted at the request of Sweden, noted good practices in the country's nuclear regulatory system and also made recommendations and suggestions for the Swedish Radiation Safety Authority (SSM) and the government. These are aimed at strengthening the effectiveness of the country's regulatory framework and functions in line with IAEA Safety Standards. ''Throughout the mission, the IRRS team received full cooperation from SSM staff in its review of Sweden's regulatory, technical and policy issues,'' said Georg Schwarz, mission leader and Deputy Director General of the Swiss nuclear regulator (ENSI). 'The staff were open and candid in their discussions and provided the fullest practicable assistance', he commented. The main observations of the IRRS Review team included the following: SSM operates as an independent regulator in an open and transparent manner with well-organized regulatory processes; SSM is receptive to feedback and strives to maintain a culture of continuous learning; and Following the TEPCO Fukushima Daiichi accident, SSM responded promptly to public demand for information and communicated effectively with the national government, the public and other interested parties. Good practices identified by the IRRS team included, though they are not limited to, the following: The consolidation of the two previous national regulatory authorities into SSM was successful; Overall, SSM's management system is comprehensive and contributes to staff efficiency and effectiveness; The nuclear power plant refurbishment programme as required by SSM enhanced safety; and Sweden's regulatory framework for high-level waste disposal is comprehensive and technically sound. The IRRS Review team identified

  7. 12 CFR 914.1 - Regulatory Report defined.

    Science.gov (United States)

    2010-01-01

    ... Bank. (b) Examples. Regulatory Report includes: (1) Call reports and reports of instrument-level risk... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Regulatory Report defined. 914.1 Section 914.1... DATA AVAILABILITY AND REPORTING § 914.1 Regulatory Report defined. (a) Definition. Regulatory Report...

  8. Measuring teamwork in health care settings: a review of survey instruments.

    Science.gov (United States)

    Valentine, Melissa A; Nembhard, Ingrid M; Edmondson, Amy C

    2015-04-01

    Teamwork in health care settings is widely recognized as an important factor in providing high-quality patient care. However, the behaviors that comprise effective teamwork, the organizational factors that support teamwork, and the relationship between teamwork and patient outcomes remain empirical questions in need of rigorous study. To identify and review survey instruments used to assess dimensions of teamwork so as to facilitate high-quality research on this topic. We conducted a systematic review of articles published before September 2012 to identify survey instruments used to measure teamwork and to assess their conceptual content, psychometric validity, and relationships to outcomes of interest. We searched the ISI Web of Knowledge database, and identified relevant articles using the search terms team, teamwork, or collaboration in combination with survey, scale, measure, or questionnaire. We found 39 surveys that measured teamwork. Surveys assessed different dimensions of teamwork. The most commonly assessed dimensions were communication, coordination, and respect. Of the 39 surveys, 10 met all of the criteria for psychometric validity, and 14 showed significant relationships to nonself-report outcomes. Evidence of psychometric validity is lacking for many teamwork survey instruments. However, several psychometrically valid instruments are available. Researchers aiming to advance research on teamwork in health care should consider using or adapting one of these instruments before creating a new one. Because instruments vary considerably in the behavioral processes and emergent states of teamwork that they capture, researchers must carefully evaluate the conceptual consistency between instrument, research question, and context.

  9. International Nuclear Safety Experts Conclude IAEA Peer Review of Swiss Regulatory Framework

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: A team of international nuclear safety experts today completed a two-week International Atomic Energy Agency (IAEA) review of the regulatory framework for nuclear safety in Switzerland. The Integrated Regulatory Review Service (IRRS) mission noted good practices in the Swiss system and also made recommendations for the nation's nuclear regulatory authority, the Swiss Federal Nuclear Safety Inspectorate (ENSI). ''Our team developed a good impression of the independent Swiss regulator - ENSI - and the team considered that ENSI deserves particular credit for its actions to improve Swiss safety capability following this year's nuclear accident in Japan,'' said IRRS Team Leader Jean-Christophe Niel of France. The mission's scope covered the Swiss nuclear regulatory framework for all types of nuclear-related activities regulated by ENSI. The mission was conducted from 20 November to 2 December, mainly at ENSI headquarters in Brugg. The team held extensive discussions with ENSI staff and visited many Swiss nuclear facilities. IRRS missions are peer reviews, not inspections or audits, and are conducted at the request of host nations. For the Swiss review, the IAEA assembled a team of 19 international experts from 14 countries. The experts came from Belgium, Brazil, the Czech Republic, Finland, France, Germany, Italy, the Republic of Korea, Norway, Russia, Slovakia, Sweden, the United Kingdom, and the United States. ''The findings of the IRRS mission will help us to further improve our work. That is part of our safety culture,'' said ENSI Director General Hans Wanner. ''As Switzerland argued at international nuclear safety meetings this year for a strengthening of the international monitoring of nuclear power, we will take action to fulfil the recommendations.'' The IRRS team highlighted several good practices of the Swiss regulatory system, including the following: ENSI requires Swiss nuclear operators to back-fit their facilities by continuously upgrading

  10. Review of probabilistic safety assessments by regulatory bodies

    International Nuclear Information System (INIS)

    2002-01-01

    This report provides guidance to assist regulatory bodies in carrying out reviews of the PSAs produced by utilities. In following this guidance, it is important that the regulatory body is able to satisfy itself that the PSA has been carried out to an acceptable standard and that it can be used for its intended applications. The review process becomes an important phase in determining the acceptability of the PSA since this provides a degree of assurance of the PSA scope, validity and limitations, as well as a better understanding of plants themselves. This report is also intended to assist technical experts managing or performing PSA reviews. A particular aim is to promote a standardized framework, terminology and form of documentation for the results of PSA reviews. The information presented in this report supports IAEA Safety Guide No. GS-G-1.2. Recommendations on the scope and methods to be used by the utility in the preparation of a PSA study is provided in IAEA Safety Guide No. NSG- 1.2. Information on these Safety Guides and other IAEA safety standards for nuclear power plants can be found on the following Internet site: http://www.iaea.org/ns/coordinet. The scope of this report covers the review of Level 1, 2 and 3 PSAs for event sequences occurring in all modes of plant operation (including full power, low power and shutdown). Where the scope of the analysis is narrower than this, a subset of the guidance can be identified and used. Information is provided on carrying out the review of a PSA throughout the PSA production process, i.e. from the initial decision to carry out the PSA through to the completion of the study and the production of the final PSA report. However, the same procedure can be applied to a completed PSA or to one already in progress. As a result of the performance of a PSA, changes to the design or operation of the plant are often identified that would increase the level of safety. This might include the addition of further safety

  11. Preparation of safety regulatory requirements for new technology like digital system

    International Nuclear Information System (INIS)

    Ito, Juichiro; Takita, Masami

    2011-01-01

    The current regulatory requirements on digital instrumentation and control system have been reviewed by JNES, considering international trend discussed in DICWG (Digital Instrumentation and Control Working Group) of MDEP (Multinational Design Evaluation Program). MDEP DICWG held in OECD/NEA (Organisation for Economic Co-operation and Development/Nuclear Energy Agency) gives the opportunity to identify the convergence of applicable standards. The working group's activities include: identifying and prioritising the member countries' challenges, practices, and needs regarding standards and regulatory guidance regarding digital instrumentation and control; identifying areas of importance and needs for convergence of existing standards and guidance or development of new standards; sharing of information; and identifying common positions among the member countries for areas of particular importance and need. The DICWG drafted common positions on specific issues which are based on the existing standards, national regulatory guidance, best practices, and group inputs using an agreed upon process and framework. Five general common positions are under discussion in this fiscal year. Simplicity in Design, Software Common Cause Failures, Software Tools, Data communication, Verification and Validation throughout the life cycle of safety systems using digital computers. In addition, the technical evaluation of standards of the Japan Electric Association about digital system for safety was made to support NISA (Nuclear and Industrial Safety Agency). (author)

  12. Problems and experience of regulatory review associated with plant construction and commissioning

    International Nuclear Information System (INIS)

    Commander, W.

    1979-01-01

    The work of the Assessment Branch of NII covering the regulatory review during design safety assessment, construction, commissioning and operation is described commencing with the nuclear licensing procedure through licence variations and conditions attached to the licence, to the final stages of plant construction up to commercial operation and full power production. The importance of the application of safety assessment principles is outlined, the importance of the Safety Inspectorate Schedule described, and the need to retain organisational and regulatory flexibility emphasised. (author)

  13. A comparative review of measurement instruments to inform and evaluate effectiveness of disability inclusive development.

    Science.gov (United States)

    Goujon, Nicolas; Devine, Alexandra; Baker, Sally M; Sprunt, Beth; Edmonds, Tanya J; Booth, Jennifer K; Keeffe, Jill E

    2014-01-01

    A review of existing measurement instruments was conducted to examine their suitability to measure disability prevalence and assess quality of life, protection of disability rights and community participation by people with disabilities, specifically within the context of development programs in low and middle-income countries. From a search of PubMed and the grey literature, potentially relevant measurement instruments were identified and examined for their content and psychometric properties, where possible. Criteria for inclusion were: based on the WHO's International Classification of Functioning Disability and Health (ICF), used quantitative methods, suitable for population-based studies of disability inclusive development in English and published after 1990. Characteristics of existing instruments were analysed according to components of the ICF and quality of life domains. Ten instruments were identified and reviewed according to the criteria listed above. Each version of instruments was analysed separately. Only three instruments included a component on quality of life. Domains from the ICF that were addressed by some but not all instruments included the environment, technology and communication. The measurement instruments reviewed covered the range of elements required to measure disability-inclusion within development contexts. However no single measurement instrument has the capacity to measure both disability prevalence and changes in quality of life according to contemporary disability paradigms. The review of measurement instruments supports the need for developing an instrument specifically intended to measure disability inclusive practice within development programs. Implications for Rehabilitation Surveys and tools are needed to plan disability inclusive development. Existing measurement tools to determine prevalence of disability, wellbeing, rights and access to the community were reviewed. No single validated tool exists for population

  14. Preparation of safety regulatory requirements for new technology like digital system

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2013-08-15

    The current regulatory requirements on digital instrumentation and control system have been reviewed by JNES, considering international trend discussed in DICWG of MDEP. MDEP DICWG held in OECD/NEA gives the opportunity to identify the convergence of applicable standards. The working group's activities include: identifying and prioritising the member countries' challenges, practices, and needs regarding standards and regulatory guidance on digital instrumentation and control; identifying areas of importance and needs for convergence of existing standards and guidance or development of new standards; sharing of information; and identifying common positions among the member countries for areas of particular importance and need. The DICWG drafted common positions on specific issues which are based on the existing standards, national regulatory guidance, best practices, and group inputs using an agreed process and framework. The following four general common positions have been discussed in this fiscal year. The Treatment of Common Cause Failure Resulting from Software within Digital Safety Systems, The Treatment of Hardware Description Language(HDL) Programmed Devices for Use in Nuclear Safety System, Factory Acceptance Test and Site Acceptance Test, The Use of Automatic Tests to Perform Surveilance for Digital Systems. (author)

  15. Review of Legislation and Regulatory Framework in Ukraine with Regard to Environmental Radiation Monitoring

    International Nuclear Information System (INIS)

    Goldammer, Wolfgang; Batandjieva, Borislava; Nasvit, Oleg; German, Olga

    2009-06-01

    The aim of this review is to compare the current legal basis and regulatory framework in Ukraine to the relevant international safety requirements and to identify shortcomings, such as deficiencies and internal contradictions. However, no assessment of its practical implementation is made beyond the aspects related to environmental radiation monitoring. The report focuses on 13 areas present in the in the Ukrainian legislation and regulatory framework: R-1 Radiation monitoring R-2 Definition of responsibilities R-3 Normal situations R-4 Emergencies R-5 Long-term monitoring R-6 Intervention in cases of lasting exposure R-7 Use of monitoring data R-8 Record keeping R-9 Reporting to the regulatory authority R-10 Public information R-11 Human and financial resources R-12 Transboundary aspects R-13 Quality assurance. For each topic a description of the current situation and an evaluation is carried out. Ranking is then supplied supported by its evaluation. In brief these categories are: A: The national legal and regulatory documents are harmonised in substance with the international safety requirements; B: Substantial differences exist between the national and international requirements which should be addressed with the view to harmonise the legislation; C: Substantial deficiencies exist in the legal and/or regulatory bases which results in no or at least partial compliance with international safety requirements. P: In addition practical issues are also provided to indicates where practical implementation of the legislation and regulatory basis is not adequate in all respects. This report then presents main observations and conclusions of the review. On this basis, the report derives general suggestions for improvement of the legal and regulatory bases. These should be considered by the Ukrainian Government and the regulatory authorities within an action plan to improve the legal basis for radiological monitoring of the environment and to facilitate its implementation

  16. Review of Legislation and Regulatory Framework in Ukraine with Regard to Environmental Radiation Monitoring

    Energy Technology Data Exchange (ETDEWEB)

    Goldammer, Wolfgang; Batandjieva, Borislava (Private Consultants (Ukraine)); Nasvit, Oleg (National Security and Defence Council of Ukraine, Kyiv (Ukraine)); German, Olga (Swedish Radiation Safety Authority, Stockholm (Sweden))

    2009-06-15

    The aim of this review is to compare the current legal basis and regulatory framework in Ukraine to the relevant international safety requirements and to identify shortcomings, such as deficiencies and internal contradictions. However, no assessment of its practical implementation is made beyond the aspects related to environmental radiation monitoring. The report focuses on 13 areas present in the in the Ukrainian legislation and regulatory framework: R-1 Radiation monitoring R-2 Definition of responsibilities R-3 Normal situations R-4 Emergencies R-5 Long-term monitoring R-6 Intervention in cases of lasting exposure R-7 Use of monitoring data R-8 Record keeping R-9 Reporting to the regulatory authority R-10 Public information R-11 Human and financial resources R-12 Transboundary aspects R-13 Quality assurance. For each topic a description of the current situation and an evaluation is carried out. Ranking is then supplied supported by its evaluation. In brief these categories are: A: The national legal and regulatory documents are harmonised in substance with the international safety requirements; B: Substantial differences exist between the national and international requirements which should be addressed with the view to harmonise the legislation; C: Substantial deficiencies exist in the legal and/or regulatory bases which results in no or at least partial compliance with international safety requirements. P: In addition practical issues are also provided to indicates where practical implementation of the legislation and regulatory basis is not adequate in all respects. This report then presents main observations and conclusions of the review. On this basis, the report derives general suggestions for improvement of the legal and regulatory bases. These should be considered by the Ukrainian Government and the regulatory authorities within an action plan to improve the legal basis for radiological monitoring of the environment and to facilitate its implementation

  17. Health literacy screening instruments for eHealth applications: a systematic review.

    Science.gov (United States)

    Collins, Sarah A; Currie, Leanne M; Bakken, Suzanne; Vawdrey, David K; Stone, Patricia W

    2012-06-01

    To systematically review current health literacy (HL) instruments for use in consumer-facing and mobile health information technology screening and evaluation tools. The databases, PubMed, OVID, Google Scholar, Cochrane Library and Science Citation Index, were searched for health literacy assessment instruments using the terms "health", "literacy", "computer-based," and "psychometrics". All instruments identified by this method were critically appraised according to their reported psychometric properties and clinical feasibility. Eleven different health literacy instruments were found. Screening questions, such as asking a patient about his/her need for assistance in navigating health information, were evaluated in seven different studies and are promising for use as a valid, reliable, and feasible computer-based approach to identify patients that struggle with low health literacy. However, there was a lack of consistency in the types of screening questions proposed. There is also a lack of information regarding the psychometric properties of computer-based health literacy instruments. Only English language health literacy assessment instruments were reviewed and analyzed. Current health literacy screening tools demonstrate varying benefits depending on the context of their use. In many cases, it seems that a single screening question may be a reliable, valid, and feasible means for establishing health literacy. A combination of screening questions that assess health literacy and technological literacy may enable tailoring eHealth applications to user needs. Further research should determine the best screening question(s) and the best synthesis of various instruments' content and methodologies for computer-based health literacy screening and assessment. Copyright © 2012 Elsevier Inc. All rights reserved.

  18. Applications of pharmacogenomics in regulatory science: a product life cycle review.

    Science.gov (United States)

    Tan-Koi, W C; Leow, P C; Teo, Y Y

    2018-05-22

    With rapid developments of pharmacogenomics (PGx) and regulatory science, it is important to understand the current PGx integration in product life cycle, impact on clinical practice thus far and opportunities ahead. We conducted a cross-sectional review on PGx-related regulatory documents and implementation guidelines in the United States and Europe. Our review found that although PGx-related guidance in both markets span across the entire product life cycle, the scope of implementation guidelines varies across two continents. Approximately one-third of Food and Drug Administration (FDA)-approved drugs with PGx information in drug labels and half of the European labels posted on PharmGKB website contain recommendations on genetic testing. The drugs affected 19 and 15 World Health Organization Anatomical Therapeutic Chemical drug classes (fourth level) in the United States and Europe, respectively, with protein kinase inhibitors (13 drugs in the United States and 16 drugs in Europe) being most prevalent. Topics of emerging interest were novel technologies, adaptive design in clinical trial and sample collection.

  19. Regulatory Review of Early Site Permit Applications

    International Nuclear Information System (INIS)

    Scott, Michael L.

    2004-01-01

    The U.S. Nuclear Regulatory Commission (NRC) has received and is reviewing three applications for early site permits (ESPs). The ESP process allows early resolution of site-related issues affecting possible construction and operation of a new nuclear power plant. The nuclear industry views a successful and predictable ESP process as an important step in assessing whether to seek authorization to construct and operate a new generation of nuclear power reactors in the United States. Because consideration of ESP applications is a first-of-a-kind activity, a number of issues have emerged prior to and during the reviews of the first three applications. Issues have included the need for design information at the ESP stage, accident analyses, quality assurance, and seismic analyses. The NRC has been working to resolve identified issues to support a Commission decision on whether to issue an ESP approximately 33-37 months after receipt of each ESP application. (authors)

  20. Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature.

    Science.gov (United States)

    Bujar, Magdalena; McAuslane, Neil; Walker, Stuart R; Salek, Sam

    2017-01-01

    Introduction: Although pharmaceutical companies, regulatory authorities, and health technology assessment (HTA) agencies have been increasingly using decision-making frameworks, it is not certain whether these enable better quality decision making. This could be addressed by formally evaluating the quality of decision-making process within those organizations. The aim of this literature review was to identify current techniques (tools, questionnaires, surveys, and studies) for measuring the quality of the decision-making process across the three stakeholders. Methods: Using MEDLINE, Web of Knowledge, and other Internet-based search engines, a literature review was performed to systematically identify techniques for assessing quality of decision making in medicines development, regulatory review, and HTA. A structured search was applied using key words and a secondary review was carried out. In addition, the measurement properties of each technique were assessed and compared. Ten Quality Decision-Making Practices (QDMPs) developed previously were then used as a framework for the evaluation of techniques identified in the review. Due to the variation in studies identified, meta-analysis was inappropriate. Results: This review identified 13 techniques, where 7 were developed specifically to assess decision making in medicines' development, regulatory review, or HTA; 2 examined corporate decision making, and 4 general decision making. Regarding how closely each technique conformed to the 10 QDMPs, the 13 techniques assessed a median of 6 QDMPs, with a mode of 3 QDMPs. Only 2 techniques evaluated all 10 QDMPs, namely the Organizational IQ and the Quality of Decision Making Orientation Scheme (QoDoS), of which only one technique, QoDoS could be applied to assess decision making of both individuals and organizations, and it possessed generalizability to capture issues relevant to companies as well as regulatory authorities. Conclusion: This review confirmed a general

  1. A Review of International Telecommunications Industry Issues, Structure, and Regulatory Problems.

    Science.gov (United States)

    Cole, Jack E.; And Others

    Industry structure studies prior to 1968 are briefly reviewed, and an overview of industrial and technological developments up to the present is provided through synopses of more recent studies. Areas covered include overseas telephone and record carriers; the creation of the Communications Satellite Corporation; the current regulatory and…

  2. A Review on the Needs of Independent Information Channel for Regulatory Body

    International Nuclear Information System (INIS)

    Raza, Hamid Saeed; Choi, Kwang Sik

    2010-01-01

    For a regulatory body it is very important to be independent not only in its actions but also in its information gathering channels. It is thus required for an organization to get requisite information for their decision making, as well as to prevail over information asymmetries. For corporate culture, information channels sometimes prove to be extensive enough to rune valuable resources and sometime base delays. The paper will reveal nature of an independent information channel. This review will additionally confer a scenario; a regulatory body may face in case of solely depending upon licensee for its information gathering. Working in the wake of this paper comprises review of allied published materials. It might be more helpful for interested ones to persist this effort by ensuring stakeholder involvement i.e. by making this sensitive topic alive through seminars and working groups

  3. Systematic Review of Measurement Property Evidence for 8 Financial Management Instruments in Populations With Acquired Cognitive Impairment.

    Science.gov (United States)

    Engel, Lisa; Chui, Adora; Beaton, Dorcas E; Green, Robin E; Dawson, Deirdre R

    2018-03-07

    To critically appraise the measurement property evidence (ie, psychometric) for 8 observation-based financial management assessment instruments. Seven databases were searched in May 2015. Two reviewers used an independent decision-agreement process to select studies of measurement property evidence relevant to populations with adulthood acquired cognitive impairment, appraise the quality of the evidence, and extract data. Twenty-one articles were selected. This review used the COnsensus-based Standards for the selection of health Measurement Instruments review guidelines and 4-point tool to appraise evidence. After appraising the methodologic quality, the adequacy of results and volume of evidence per instrument were synthesized. Measurement property evidence with high risk of bias was excluded from the synthesis. The volume of measurement property evidence per instrument is low; most instruments had 1 to 3 included studies. Many included studies had poor methodologic quality per measurement property evidence area examined. Six of the 8 instruments reviewed had supporting construct validity/hypothesis-testing evidence of fair methodologic quality. There is a dearth of acceptable quality content validity, reliability, and responsiveness evidence for all 8 instruments. Rehabilitation practitioners assess financial management functions in adults with acquired cognitive impairments. However, there is limited published evidence to support using any of the reviewed instruments. Practitioners should exercise caution when interpreting the results of these instruments. This review highlights the importance of appraising the quality of measurement property evidence before examining the adequacy of the results and synthesizing the evidence. Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  4. Assessing health status and quality-of-life instruments: attributes and review criteria.

    Science.gov (United States)

    Aaronson, Neil; Alonso, Jordi; Burnam, Audrey; Lohr, Kathleen N; Patrick, Donald L; Perrin, Edward; Stein, Ruth E

    2002-05-01

    The field of health status and quality of life (QoL) measurement - as a formal discipline with a cohesive theoretical framework, accepted methods, and diverse applications--has been evolving for the better part of 30 years. To identify health status and QoL instruments and review them against rigorous criteria as a precursor to creating an instrument library for later dissemination, the Medical Outcomes Trust in 1994 created an independently functioning Scientific Advisory Committee (SAC). In the mid-1990s, the SAC defined a set of attributes and criteria to carry out instrument assessments; 5 years later, it updated and revised these materials to take account of the expanding theories and technologies upon which such instruments were being developed. This paper offers the SAC's current conceptualization of eight key attributes of health status and QoL instruments (i.e., conceptual and measurement model; reliability; validity; responsiveness; interpretability; respondent and administrative burden; alternate forms; and cultural and language adaptations) and the criteria by which instruments would be reviewed on each of those attributes. These are suggested guidelines for the field to consider and debate; as measurement techniques become both more familiar and more sophisticated, we expect that experts will wish to update and refine these criteria accordingly.

  5. VALIDATION OF ANALYTICAL METHODS AND INSTRUMENTATION FOR BERYLLIUM MEASUREMENT: REVIEW AND SUMMARY OF AVAILABLE GUIDES, PROCEDURES, AND PROTOCOLS

    Energy Technology Data Exchange (ETDEWEB)

    Ekechukwu, A

    2009-05-27

    Method validation is the process of evaluating whether an analytical method is acceptable for its intended purpose. For pharmaceutical methods, guidelines from the United States Pharmacopeia (USP), International Conference on Harmonisation (ICH), and the United States Food and Drug Administration (USFDA) provide a framework for performing such valications. In general, methods for regulatory compliance must include studies on specificity, linearity, accuracy, precision, range, detection limit, quantitation limit, and robustness. Elements of these guidelines are readily adapted to the issue of validation for beryllium sampling and analysis. This document provides a listing of available sources which can be used to validate analytical methods and/or instrumentation for beryllium determination. A literature review was conducted of available standard methods and publications used for method validation and/or quality control. A comprehensive listing of the articles, papers and books reviewed is given in the Appendix. Available validation documents and guides are listed therein; each has a brief description of application and use. In the referenced sources, there are varying approches to validation and varying descriptions of the valication process at different stages in method development. This discussion focuses on valication and verification of fully developed methods and instrumentation that have been offered up for use or approval by other laboratories or official consensus bodies such as ASTM International, the International Standards Organization (ISO) and the Association of Official Analytical Chemists (AOAC). This review was conducted as part of a collaborative effort to investigate and improve the state of validation for measuring beryllium in the workplace and the environment. Documents and publications from the United States and Europe are included. Unless otherwise specified, all referenced documents were published in English.

  6. Selecting Suicide Ideation Assessment Instruments: A Meta-Analytic Review

    Science.gov (United States)

    Erford, Bradley T.; Jackson, Jessica; Bardhoshi, Gerta; Duncan, Kelly; Atalay, Zumra

    2018-01-01

    Psychometric meta-analyses and reviews were provided for four commonly used suicidal ideation instruments: the Beck Scale for Suicide Ideation, the Suicide Ideation Questionnaire, the Suicide Probability Scale, and Columbia--Suicide Severity Rating Scale. Practical and technical issues and best use recommendations for screening and outcome…

  7. Safety cases for radioactive waste disposal facilities: guidance on confidence building and regulatory review IAEA-ASAM co-ordinated research project

    International Nuclear Information System (INIS)

    Ben Belfadhel, M.; Bennett, D.G.; Metcalf, P.; Nys, V.; Goldammer, W.

    2008-01-01

    The IAEA has been conducting two co-ordinated research programmes (CRPs) projects to develop and apply improved safety assessment methodologies for near-surface radioactive waste disposal facilities. The more recent of these projects, ASAM (application of safety assessment methodologies), included a Regulatory Review Working Group (RRWG) which has been working to develop guidance on how to gain confidence in safety assessments and safety cases, and on how to conduct regulatory reviews of safety assessments. This paper provides an overview of the ASAM project, focusing on the safety case and regulatory review. (authors)

  8. The cross-cultural equivalence of participation instruments: a systematic review.

    Science.gov (United States)

    Stevelink, S A M; van Brakel, W H

    2013-07-01

    Concepts such as health-related quality of life, disability and participation may differ across cultures. Consequently, when assessing such a concept using a measure developed elsewhere, it is important to test its cultural equivalence. Previous research suggested a lack of cultural equivalence testing in several areas of measurement. This paper reviews the process of cross-cultural equivalence testing of instruments to measure participation in society. An existing cultural equivalence framework was adapted and used to assess participation instruments on five categories of equivalence: conceptual, item, semantic, measurement and operational equivalence. For each category, several aspects were rated, resulting in an overall category rating of 'minimal/none', 'partial' or 'extensive'. The best possible overall study rating was five 'extensive' ratings. Articles were included if the instruments focussed explicitly on measuring 'participation' and were theoretically grounded in the ICIDH(-2) or ICF. Cross-validation articles were only included if it concerned an adaptation of an instrument developed in a high or middle-income country to a low-income country or vice versa. Eight cross-cultural validation studies were included in which five participation instruments were tested (Impact on Participation and Autonomy, London Handicap Scale, Perceived Impact and Problem Profile, Craig Handicap Assessment Reporting Technique, Participation Scale). Of these eight studies, only three received at least two 'extensive' ratings for the different categories of equivalence. The majority of the cultural equivalence ratings given were 'partial' and 'minimal/none'. The majority of the 'none/minimal' ratings were given for item and measurement equivalence. The cross-cultural equivalence testing of the participation instruments included leaves much to be desired. A detailed checklist is proposed for designing a cross-validation study. Once a study has been conducted, the checklist can

  9. Assessing patient-centred communication in teaching: a systematic review of instruments.

    Science.gov (United States)

    Brouwers, Marianne; Rasenberg, Ellemieke; van Weel, Chris; Laan, Roland; van Weel-Baumgarten, Evelyn

    2017-11-01

    Patient-centred communication is a key component of patient centredness in medical care. Therefore, adequate education in and assessment of patient-centred communication skills are necessary. In general, feedback on communication skills is most effective when it is provided directly and is systematic. This calls for adequate measurement instruments. The aim of this study was to provide a systematic review of existing instruments that measure patient centredness in doctor-patient communication and can be used to provide direct feedback. A systematic review was conducted using an extensive validated search strategy for measurement instruments in PubMed, EMBASE, PsycINFO and CINAHL. The databases were searched from their inception to 1 July 2016. Articles describing the development or evaluation of the measurement properties of instruments that measure patient centredness (by applying three or more of the six dimensions of a published definition of patient centredness) in doctor-patient communication and that can be used for the provision of direct feedback were included. The methodological quality of measurement properties was evaluated using the COSMIN checklist. Thirteen articles describing 14 instruments measuring patient centredness in doctor-patient communication were identified. These studies cover a wide range of settings and patient populations, and vary in the dimensions of patient centredness applied and in methodological quality on aspects of reliability and validity. This review gives a comprehensive overview of all instruments available for the measurement of patient centredness in doctor-patient communication that can be used for the provision of direct feedback and are described in the literature. Despite the widely felt need for valid and reliable instruments for the measurement of patient-centred communication, most of the instruments currently available have not been thoroughly investigated. Therefore, we recommend further research into and

  10. Health Literacy Screening Instruments for eHealth Applications: A Systematic Review

    Science.gov (United States)

    Collins, Sarah A.; Currie, Leanne M.; Bakken, Suzanne; Vawdrey, David K.; Stone, Patricia W.

    2012-01-01

    Objective To systematically review current health literacy (HL) instruments for use in consumer-facing and mobile health information technology screening and evaluation tools. Design The databases, PubMed, OVID, Google Scholar, Cochrane Library and Science Citation Index, were searched for health literacy assessment instruments using the terms “health”, “literacy”, “computer-based,” and “psychometrics”. All instruments identified by this method were critically appraised according to their reported psychometric properties and clinical feasibility. Results Eleven different health literacy instruments were found. Screening questions, such as asking a patient about his/her need for assistance in navigating health information, were evaluated in 7 different studies and are promising for use as a valid, reliable, and feasible computer-based approach to identify patients that struggle with low health literacy. However, there was a lack of consistency in the types of screening questions proposed. There is also a lack of information regarding the psychometric properties of computer-based health literacy instruments. Limitations Only English language health literacy assessment instruments were reviewed and analyzed. Conclusions Current health literacy screening tools demonstrate varying benefits depending on the context of their use. In many cases, it seems that a single screening question may be a reliable, valid, and feasible means for establishing health literacy. A combination of screening questions that assess health literacy and technological literacy may enable tailoring eHealth applications to user needs. Further research should determine the best screening question(s) and the best synthesis of various instruments’ content and methodologies for computer-based health literacy screening and assessment. PMID:22521719

  11. Organization and practices on regulatory review in the licensing process of nuclear power plants in Spain

    International Nuclear Information System (INIS)

    Trueba, P.

    1979-01-01

    The actual organisation, practices and experience of the JEN Nuclear Safety Department on the regulatory review in the licensing process of nuclear power plants in Spain, are presented. Topics to be covered are: The structure, organisation, staff and principal functional areas of the NSD, the academic qualifications and work experience of the NSD personnel, recruiting and training, the conduct of the regulatory review during the licensing process and working procedures, the manpower and coverage of the different technical areas, the principal problems and conclusions. (author)

  12. Intelligence Assessment Instruments in Adult Prison Populations: A Systematic Review.

    Science.gov (United States)

    van Esch, A Y M; Denzel, A D; Scherder, E J A; Masthoff, E D M

    2017-10-01

    Detection of intellectual disability (ID) in the penitentiary system is important for the following reasons: (a) to provide assistance to people with ID in understanding their legal rights and court proceedings; (b) to facilitate rehabilitation programs tailored to ID patients, which improves the enhancement of their quality of life and reduces their risk of reoffending; and (c) to provide a reliable estimate of the risk of offence recidivism. It requires a short assessment instrument that provides a reliable estimation of a person's intellectual functioning at the earliest possible stage of this process. The aim of this systematic review is (a) to provide an overview of recent short assessment instruments that provide a full-scale IQ score in adult prison populations and (b) to achieve a quality measurement of the validation studies regarding these instruments to determine which tests are most feasible in this target population. The Preferred Reporting Items for Systematic reviews and Meta-Analyses Statement is used to ensure reliability. The Satz-Mögel, an item-reduction short form of the Wechsler Adult Intelligence Scale, shows the highest correlation with the golden standard and is described to be most reliable. Nevertheless, when it comes to applicability in prison populations, the shorter and less verbal Quick Test can be preferred over others. Without affecting these conclusions, major limitations emerge from the present systematic review, which give rise to several important recommendations for further research.

  13. Evolution in performance assessment modeling as a result of regulatory review

    Energy Technology Data Exchange (ETDEWEB)

    Rowat, J.H.; Dolinar, G.M.; Stephens, M.E. [AECL Chalk River Labs., Ontario (Canada)] [and others

    1995-12-31

    AECL is planning to build the IRUS (Intrusion Resistant Underground Structure) facility for near-surface disposal of LLRW. The PSAR (preliminary safety assessment report) was subject to an initial regulatory review during mid-1992. The regulatory authority provided comments on many aspects of the safety assessment documentation including a number of questions on specific PA (Performance Assessment) modelling assumptions. As a result of these comments as well as a separate detailed review of the IRUS disposal concept, changes were made to the conceptual and mathematical models. The original disposal concept included a non-sorbing vault backfill, with a strong reliance on the wasteform as a barrier. This concept was altered to decrease reliance on the wasteform by replacing the original backfill with a sand/clinoptilolite mix, which is a better sorber of metal cations. This change lead to changes in the PA models which in turn altered the safety case for the facility. This, and other changes that impacted performance assessment modelling are the subject of this paper.

  14. Overall review strategy for the Nuclear Regulatory Commission's High-Level Waste Repository Program

    International Nuclear Information System (INIS)

    Johnson, R.L.

    1994-11-01

    The Overall Review Strategy gives general guidance to the Nuclear Regulatory Commission staff for conducting it's license application and pre-license application reviews. These reviews are in support of the Commission's construction authorization decision for a geologic repository for the disposal of high-level radioactive waste. Objectives and strategies are defined that focus the staff's reviews on determining compliance with requirements of 10 CFR Part 60. These strategies define how the staff prioritizes its reviews on those key technical uncertainties considered to be most important to repository performance. Strategies also give guidance for developing, in an integrated way, the License Application Review Plan together with supporting performance assessments, analyses, and research

  15. Comparison of ISO 9000 and recent software life cycle standards to nuclear regulatory review guidance

    International Nuclear Information System (INIS)

    Preckshot, G.G.; Scott, J.A.

    1998-01-01

    Lawrence Livermore National Laboratory is assisting the Nuclear Regulatory Commission with the assessment of certain quality and software life cycle standards to determine whether additional guidance for the U.S. nuclear regulatory context should be derived from the standards. This report describes the nature of the standards and compares the guidance of the standards to that of the recently updated Standard Review Plan

  16. Satisfaction measurement instruments for healthcare service users: a systematic review

    OpenAIRE

    Almeida, Renato Santos de; Bourliataux-Lajoinie, Stephane; Martins, Mônica

    2015-01-01

    Patient satisfaction surveys can be an interesting way to improve quality and discuss the concept of patient-centered care. This study aimed to conduct a systematic review of the validated patient satisfaction measurement instruments applied in healthcare. The systematic review searched the MEDLINE/PubMed, LILACS, SciELO, Scopus and Web of Knowledge. The search strategy used the terms: "Patient Satisfaction" AND "Patient centered care" AND "Healthcare survey OR Satisfaction questionnaire" AND...

  17. 5 CFR 847.102 - Regulatory structure.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Regulatory structure. 847.102 Section 847.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... INSTRUMENTALITIES General Provisions § 847.102 Regulatory structure. (a)(1) Subpart A of this part contains...

  18. Safety evaluation for instrumentation and control system upgrading project of Malaysian TRIGA MARK II PUSPATI Research reactor

    International Nuclear Information System (INIS)

    Ridha Roslan; Nik Mohd Faiz Khairuddin

    2013-01-01

    Full-text: Malaysian TRIGA MARK II research reactor has been in safe operation since its first criticality in 1982. The reactor is licensed to be operated by Malaysian Nuclear Agency to perform training and research development related activities. Due to its extensive operation since last three decades, the option of modifications for safety and safety-related item and component become a necessary to replace the outdated equipment to a stat-of-art, reliable technologies. This paper will present the current regulatory activities performed by Atomic Energy Licensing Board (AELB) to ensure the upgrading of analogue to digital instrumentation and control system is implemented in safe manner. The review activity includes documentation review, manufacturer quality audit and on-site inspection for commissioning. The review performed by AELB is based on The International Atomic Energy Agency (IAEA) Safety Requirements NS-R-4, entitled Safety of Research Reactors. During this endeavour, AELB seeks technical cooperation from Korea Institute of Nuclear Safety (KINS), the nuclear experts organization of the country of origin of the instrumentation and control technology. The regulatory activity is still on-going and is expected to be completed by issuance of Authorization for Restart on December 2013. (author)

  19. 75 FR 75678 - Determination of Regulatory Review Period for Purposes of Patent Extension; STELARA

    Science.gov (United States)

    2010-12-06

    ..., animal drug product, medical device, food additive, or color additive) was subject to regulatory review... or systemic therapy. Subsequent to this approval, the Patent and Trademark Office received a patent...

  20. Impact of regulatory guidances and drug regulation on risk minimization interventions in drug safety: a systematic review.

    Science.gov (United States)

    Nkeng, Lenhangmbong; Cloutier, Anne-Marie; Craig, Camille; Lelorier, Jacques; Moride, Yola

    2012-07-01

    Therapeutic risk management has received growing interest in recent years, particularly since the publication of regulatory guidances in 2005 and 2006, paralleled with a change in drug regulation. The characteristics of risk minimization interventions (RMIs) that have been implemented or approved remain inadequately explored. The aim of this study was to review RMIs published in the literature or posted on regulatory agency websites over the past 10 years, and to assess whether publication of regulatory guidances on risk management is associated with changes in the number and types of interventions. Sources were searched for RMIs published/posted between 1 January 2000 and 31 December 2009. For the literature search, MEDLINE and EMBASE databases were used using key words related to drug safety (i.e. 'drug toxicity') and the individual RMI names. The website review involved searches of major regulatory authority websites such as the European Medicines Agency, US FDA, Health Canada, the UK's Medicines and Healthcare products Regulatory Agency, Japan's Pharmaceutical and Medical Devices Agency and Australia's Therapeutic Goods Administration. The following eligibility criteria were applied for inclusion in the review: published/posted between the years 2000 and 2009, inclusive; involving drug products; use in humans; and involving RMIs, or tools used to increase the reporting of adverse events (AEs). Natural healthcare products, devices, diagnostic chemicals, pregnancy registries without follow-up, medication errors and products not used as therapy for illness were not retained. For each source, the following characteristics were extracted: nature of the intervention, target population, therapeutic area, AE(s) of special interest, country/regulatory agency and year of publication. A total of 119 unique interventions were identified in the literature (54 published in 2000-4 and 65 published in 2005-9). Interventions included educational material (n = 37; 31%), black

  1. 76 FR 14671 - Determination of Regulatory Review Period for Purposes of Patent Extension; ISTODAX

    Science.gov (United States)

    2011-03-17

    ..., medical device, food additive, or color additive) was subject to regulatory review by FDA before the item... in patients who have received at least one prior systemic therapy. Subsequent [[Page 14672

  2. Transportation of Large Wind Components: A Permitting and Regulatory Review

    Energy Technology Data Exchange (ETDEWEB)

    Levine, Aaron [National Renewable Energy Lab. (NREL), Golden, CO (United States); Cook, Jeff [National Renewable Energy Lab. (NREL), Golden, CO (United States)

    2016-09-01

    This report summarizes permitting and regulatory issues associated with transporting wind turbine blades, towers, and nacelles as well as large transformers (wind components). These wind components are commonly categorized as oversized and overweight (OSOW) and require specific permit approvals from state and local jurisdictions. The report was developed based on a Quadrennial Energy Review (QER) recommendation on logistical requirements for the transportation of 'oversized or high-consequence energy materials, equipment, and components.'

  3. 77 FR 26290 - Determination of Regulatory Review Period for Purposes of Patent Extension; KRYSTEXXA

    Science.gov (United States)

    2012-05-03

    ..., medical device, food additive, or color additive) was subject to regulatory review by FDA before the item... chronic gout in adult patients refractory to conventional therapy. Subsequent to this approval, the Patent...

  4. Averting Regulatory Enforcement: Evidence from New Source Review

    Energy Technology Data Exchange (ETDEWEB)

    Keohane, N.O.; Mansur, E.T.; Voynov, A. [Yale University, New York, NY (USA)

    2009-09-15

    This paper explores firms' response to regulatory enforcement. New Source Review (NSR), a provision of the Clean Air Act, imposes stringent emissions limitations on significantly modified older power plants. In 1999, the Environmental Protection Agency (EPA) sued owners of 46 plants for NSR violations. We study how electricity companies respond to both the perceived threat of future action, and the action itself. A discrete choice model estimates plants likelihood of being named in lawsuits increases with large historic emissions and investments. On the eve of the lawsuits, emissions at plants with a one standard deviation greater probability of being sued fell approximately 10%.

  5. 75 FR 76741 - Determination of Regulatory Review Period for Purposes of Patent Extension; SABRIL

    Science.gov (United States)

    2010-12-09

    ..., medical device, food additive, or color additive) was subject to regulatory review by FDA before the item... adults. It should be used as adjunctive therapy in patients who have responded inadequately to several...

  6. International Expert Team Concludes IAEA Peer Review of Bulgaria's Regulatory Framework for Nuclear and Radiation Safety

    International Nuclear Information System (INIS)

    2013-01-01

    Full text: An international team of senior nuclear safety and radiation protection experts today concluded a 12-day mission to review the regulatory framework for nuclear and radiation safety in Bulgaria. The Integrated Regulatory Review Service (IRRS) mission, conducted at the request of the Government of Bulgaria, identified a series of good practices and made recommendations to help enhance the overall performance of the regulatory system. IRRS missions, which were initiated in 2006, are peer reviews based on the IAEA Safety Standards; they are not inspections or audits. ''Bulgaria has a clear national policy and strategy for safety, which are well in line with international standards and practices and contribute to a high level of nuclear safety,'' said Mission Team Leader Marta Ziakova, Chairperson of the Nuclear Regulatory Authority of the Slovak Republic. The mission team, which conducted the review from 8 to 19 April, was made up of 16 senior regulatory experts from 16 nations, and six IAEA staff. ''The results of the IRRS mission will be valuable for the future development and reinforcement of the Bulgarian Nuclear Safety Agency (BNRA). The use of international standards and good practices helps to improve global harmonization in all areas of nuclear safety and radiation protection,'' said Sergey Tzotchev, Chairman of the BNRA. Among the main observations in its preliminary report, the IRRS mission team found that BNRA operates as an independent regulatory body and conducts its regulatory processes in an open and transparent manner. In line with the IAEA Action Plan on Nuclear Safety, the mission reviewed the regulatory implications for Bulgaria of the March 2011 accident at TEPCO's Fukushima Daiichi Nuclear Power Station in Japan. It found that the BNRA's response to the lessons learned from that accident was both prompt and effective. Strengths and good practices identified by the IRRS team include the following: A no-blame policy is enshrined in law for

  7. University Reactor Instrumentation Program

    International Nuclear Information System (INIS)

    Vernetson, W.G.

    1992-11-01

    Recognizing that the University Reactor Instrumentation Program was developed in response to widespread needs in the academic community for modernization and improvement of research and training reactors at institutions such as the University of Florida, the items proposed to be supported by this grant over its two year period have been selected as those most likely to reduce foreed outages, to meet regulatory concerns that had been expressed in recent years by Nuclear Regulatory Commission inspectors or to correct other facility problems and limitations. Department of Energy Grant Number DE-FG07-90ER129969 was provided to the University of Florida Training Reactor(UFTR) facility through the US Department of Energy's University Reactor Instrumentation Program. The original proposal submitted in February, 1990 requested support for UFTR facility instrumentation and equipment upgrades for seven items in the amount of $107,530 with $13,800 of this amount to be the subject of cost sharing by the University of Florida and $93,730 requested as support from the Department of Energy. A breakdown of the items requested and total cost for the proposed UFTR facility instrumentation and equipment improvements is presented

  8. Positive lists of cosmetic ingredients: Analytical methodology for regulatory and safety controls – A review

    International Nuclear Information System (INIS)

    Lores, Marta; Llompart, Maria; Alvarez-Rivera, Gerardo; Guerra, Eugenia; Vila, Marlene; Celeiro, Maria; Lamas, J. Pablo; Garcia-Jares, Carmen

    2016-01-01

    Cosmetic products placed on the market and their ingredients, must be safe under reasonable conditions of use, in accordance to the current legislation. Therefore, regulated and allowed chemical substances must meet the regulatory criteria to be used as ingredients in cosmetics and personal care products, and adequate analytical methodology is needed to evaluate the degree of compliance. This article reviews the most recent methods (2005–2015) used for the extraction and the analytical determination of the ingredients included in the positive lists of the European Regulation of Cosmetic Products (EC 1223/2009): comprising colorants, preservatives and UV filters. It summarizes the analytical properties of the most relevant analytical methods along with the possibilities of fulfilment of the current regulatory issues. The cosmetic legislation is frequently being updated; consequently, the analytical methodology must be constantly revised and improved to meet safety requirements. The article highlights the most important advances in analytical methodology for cosmetics control, both in relation to the sample pretreatment and extraction and the different instrumental approaches developed to solve this challenge. Cosmetics are complex samples, and most of them require a sample pretreatment before analysis. In the last times, the research conducted covering this aspect, tended to the use of green extraction and microextraction techniques. Analytical methods were generally based on liquid chromatography with UV detection, and gas and liquid chromatographic techniques hyphenated with single or tandem mass spectrometry; but some interesting proposals based on electrophoresis have also been reported, together with some electroanalytical approaches. Regarding the number of ingredients considered for analytical control, single analyte methods have been proposed, although the most useful ones in the real life cosmetic analysis are the multianalyte approaches. - Highlights:

  9. Positive lists of cosmetic ingredients: Analytical methodology for regulatory and safety controls – A review

    Energy Technology Data Exchange (ETDEWEB)

    Lores, Marta, E-mail: marta.lores@usc.es; Llompart, Maria; Alvarez-Rivera, Gerardo; Guerra, Eugenia; Vila, Marlene; Celeiro, Maria; Lamas, J. Pablo; Garcia-Jares, Carmen

    2016-04-07

    Cosmetic products placed on the market and their ingredients, must be safe under reasonable conditions of use, in accordance to the current legislation. Therefore, regulated and allowed chemical substances must meet the regulatory criteria to be used as ingredients in cosmetics and personal care products, and adequate analytical methodology is needed to evaluate the degree of compliance. This article reviews the most recent methods (2005–2015) used for the extraction and the analytical determination of the ingredients included in the positive lists of the European Regulation of Cosmetic Products (EC 1223/2009): comprising colorants, preservatives and UV filters. It summarizes the analytical properties of the most relevant analytical methods along with the possibilities of fulfilment of the current regulatory issues. The cosmetic legislation is frequently being updated; consequently, the analytical methodology must be constantly revised and improved to meet safety requirements. The article highlights the most important advances in analytical methodology for cosmetics control, both in relation to the sample pretreatment and extraction and the different instrumental approaches developed to solve this challenge. Cosmetics are complex samples, and most of them require a sample pretreatment before analysis. In the last times, the research conducted covering this aspect, tended to the use of green extraction and microextraction techniques. Analytical methods were generally based on liquid chromatography with UV detection, and gas and liquid chromatographic techniques hyphenated with single or tandem mass spectrometry; but some interesting proposals based on electrophoresis have also been reported, together with some electroanalytical approaches. Regarding the number of ingredients considered for analytical control, single analyte methods have been proposed, although the most useful ones in the real life cosmetic analysis are the multianalyte approaches. - Highlights:

  10. Movement kinematics and cyclic fatigue of NiTi rotary instruments: a systematic review.

    Science.gov (United States)

    Ferreira, F; Adeodato, C; Barbosa, I; Aboud, L; Scelza, P; Zaccaro Scelza, M

    2017-02-01

    The aim of this review was to provide a detailed analysis of the literature concerning the correlation between different movement kinematics and the cyclic fatigue resistance of NiTi rotary endodontic instruments. From June 2014 to August 2015, four independent reviewers comprehensively and systematically searched the Medline (PubMed), EMBASE, Web of Science, Scopus and Google Scholar databases for works published since January 2005, using the following search terms: endodontics; nickel-titanium rotary files; continuous rotation; reciprocating motion; cyclic fatigue. In addition to the electronic searches, manual searches were performed to include articles listed in the reference sections of high-impact published articles that were not indexed in the databases. Laboratory studies in English language were considered for this review. The electronic and manual searches resulted in identification of 75 articles. Based on the inclusion criteria, 32 articles were selected for analysis of full-text copies. Specific analysis was then made of 20 articles that described the effects of reciprocating and continuous movements on cyclic fatigue of the instruments. A wide range of testing conditions and methodologies have been used to compare the cyclic fatigue resistance of rotary endodontic instruments. Most studies report that reciprocating motion improves the fatigue resistance of endodontic instruments, compared to continuous rotation, independent of other variables such as the speed of rotation, the angle or radius of curvature of simulated canals, geometry and taper, or the surface characteristics of the NiTi instruments. © 2016 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  11. Development of regulatory guidance for risk-informing digital system reviews

    International Nuclear Information System (INIS)

    Arndt, S. A.

    2006-01-01

    In 1995, the U.S. Nuclear Regulatory Commission (NRC) issued the Probabilistic Risk Assessment (PRA) Policy Statement, which encourages the increased use of PRA and associated analyses in all regulatory matters to the extent supported by the state-of-the-art in PRA and the data. This policy applies, in part, to the review of digital systems, which offer the potential to improve plant safety and reliability through such features as increased hardware reliability and stability and improved failure detection capability. However, there are presently no universally accepted methods for modeling digital systems in current-generation PRAs. Further, there are ongoing debates among the PRA technical community regarding the level of detail that any digital system reliability model must have to adequately model the complex system interactions that can contribute to digital system failure modes. Moreover, for PRA modeling of digital reactor protection and control systems, direct interactions between system components and indirect interactions through controlled/supervised plant processes may necessitate the use of dynamic PRA methodologies. This situation has led the NRC to consider developing performance based rather than prescriptive regulatory guidance in this area. This paper will discuss the development of this guidance and some preliminary concepts. (authors)

  12. The Development and Evaluation of a Novel Instrument Assessing Residents' Discharge Summaries.

    Science.gov (United States)

    Hommos, Musab S; Kuperman, Ethan F; Kamath, Aparna; Kreiter, Clarence D

    2017-04-01

    To develop and determine the reliability of a novel measurement instrument assessing the quality of residents' discharge summaries. In 2014, the authors created a discharge summary evaluation instrument based on consensus recommendations from national regulatory bodies and input from primary care providers at their institution. After a brief pilot, they used the instrument to evaluate discharge summaries written by first-year internal medicine residents (n = 24) at a single U.S. teaching hospital during the 2013-2014 academic year. They conducted a generalizability study to determine the reliability of the instrument and a series of decision studies to determine the number of discharge summaries and raters needed to achieve a reliable evaluation score. The generalizability study demonstrated that 37% of the variance reflected residents' ability to generate an adequate discharge summary (true score variance). The decision studies estimated that the mean score from six discharge summary reviews completed by a unique rater for each review would yield a reliability coefficient of 0.75. Because of high interrater reliability, multiple raters per discharge summary would not significantly enhance the reliability of the mean rating. This evaluation instrument reliably measured residents' performance writing discharge summaries. A single rating of six discharge summaries can achieve a reliable mean evaluation score. Using this instrument is feasible even for programs with a limited number of inpatient encounters and a small pool of faculty preceptors.

  13. Environmental policy and economic efficiency: tradable permits versus regulatory instrument to control air pollution: a comparative approach USA/France

    International Nuclear Information System (INIS)

    Cros, Ch.

    1998-12-01

    The key issue of the thesis paradox of the weak implementation of economic instruments whereas 1) they are theoretically and also empirically considered as efficient; 2) the market imposes itself as the central reference to modem economies; and 3) economic efficiency is nowadays a legitimacy measure of public policies. Two different answers can be given: either theoretical analysis does not enable to explain the real economic efficiency of a political instrument, or environmental policies do not have economic efficiency as their main objective. The analysis take place in a context of a limited rationality and an inter-temporal consistency of public policies. The purpose is to understand the role of economic efficiency criteria during the adoption, building, and evolution of an environmental policy with an analytical point of view, and not a normative one. The institutional analysis of the American and the French pollution control policies, representative of the implementation of a trading permit system for the first, and of a regulatory instrument for the second, prove that the theoretical analysis of an instrument can not explain a real coordination, but only one organizational form among others. An institutional trajectory is the interpretation of policy instruments of policy instruments from 5 fundamental elements: the nature of the legitimacy of the policy; the nature of the regulator hypothesis on the information; the nature of the decision-making basis; the nature of the collective action. A coordination changes when the occurrence of an event moves one of the fundamental elements, and disorganizes the satisfying equilibrium of the agents. Then, the economic efficiency becomes a negotiation point. A political instrument is adopted for its own ability to solve a dysfunction without disrupting the coordination. (author)

  14. INSTRUMENTS MEASURING PERCEIVED RACISM/RACIAL DISCRIMINATION: REVIEW AND CRITIQUE OF FACTOR ANALYTIC TECHNIQUES

    Science.gov (United States)

    Atkins, Rahshida

    2015-01-01

    Several compendiums of instruments that measure perceived racism and/or discrimination are present in the literature. Other works have reviewed the psychometric properties of these instruments in terms of validity and reliability and have indicated if the instrument was factor analyzed. However, little attention has been given to the quality of the factor analysis performed. The aim of this study was to evaluate the exploratory factor analyses done on instruments measuring perceived racism/racial discrimination using guidelines from experts in psychometric theory. The techniques used for factor analysis were reviewed and critiqued and the adequacy of reporting was evaluated. Internet search engines and four electronic abstract databases were used to identify 16 relevant instruments that met the inclusion/exclusion criteria. Principal component analysis was the most frequent method of extraction (81%). Sample sizes were adequate for factor analysis in 81 percent of studies. The majority of studies reported appropriate criteria for the acceptance of un-rotated factors (81%) and justified the rotation method (75%). Exactly 94 percent of studies reported partially acceptable criteria for the acceptance of rotated factors. The majority of articles (69%) reported adequate coefficient alphas for the resultant subscales. In 81 percent of the studies, the conceptualized dimensions were supported by factor analysis. PMID:25626225

  15. Factor analysis methods and validity evidence: A systematic review of instrument development across the continuum of medical education

    Science.gov (United States)

    Wetzel, Angela Payne

    Previous systematic reviews indicate a lack of reporting of reliability and validity evidence in subsets of the medical education literature. Psychology and general education reviews of factor analysis also indicate gaps between current and best practices; yet, a comprehensive review of exploratory factor analysis in instrument development across the continuum of medical education had not been previously identified. Therefore, the purpose for this study was critical review of instrument development articles employing exploratory factor or principal component analysis published in medical education (2006--2010) to describe and assess the reporting of methods and validity evidence based on the Standards for Educational and Psychological Testing and factor analysis best practices. Data extraction of 64 articles measuring a variety of constructs that have been published throughout the peer-reviewed medical education literature indicate significant errors in the translation of exploratory factor analysis best practices to current practice. Further, techniques for establishing validity evidence tend to derive from a limited scope of methods including reliability statistics to support internal structure and support for test content. Instruments reviewed for this study lacked supporting evidence based on relationships with other variables and response process, and evidence based on consequences of testing was not evident. Findings suggest a need for further professional development within the medical education researcher community related to (1) appropriate factor analysis methodology and reporting and (2) the importance of pursuing multiple sources of reliability and validity evidence to construct a well-supported argument for the inferences made from the instrument. Medical education researchers and educators should be cautious in adopting instruments from the literature and carefully review available evidence. Finally, editors and reviewers are encouraged to recognize

  16. Positive lists of cosmetic ingredients: Analytical methodology for regulatory and safety controls - A review.

    Science.gov (United States)

    Lores, Marta; Llompart, Maria; Alvarez-Rivera, Gerardo; Guerra, Eugenia; Vila, Marlene; Celeiro, Maria; Lamas, J Pablo; Garcia-Jares, Carmen

    2016-04-07

    Cosmetic products placed on the market and their ingredients, must be safe under reasonable conditions of use, in accordance to the current legislation. Therefore, regulated and allowed chemical substances must meet the regulatory criteria to be used as ingredients in cosmetics and personal care products, and adequate analytical methodology is needed to evaluate the degree of compliance. This article reviews the most recent methods (2005-2015) used for the extraction and the analytical determination of the ingredients included in the positive lists of the European Regulation of Cosmetic Products (EC 1223/2009): comprising colorants, preservatives and UV filters. It summarizes the analytical properties of the most relevant analytical methods along with the possibilities of fulfilment of the current regulatory issues. The cosmetic legislation is frequently being updated; consequently, the analytical methodology must be constantly revised and improved to meet safety requirements. The article highlights the most important advances in analytical methodology for cosmetics control, both in relation to the sample pretreatment and extraction and the different instrumental approaches developed to solve this challenge. Cosmetics are complex samples, and most of them require a sample pretreatment before analysis. In the last times, the research conducted covering this aspect, tended to the use of green extraction and microextraction techniques. Analytical methods were generally based on liquid chromatography with UV detection, and gas and liquid chromatographic techniques hyphenated with single or tandem mass spectrometry; but some interesting proposals based on electrophoresis have also been reported, together with some electroanalytical approaches. Regarding the number of ingredients considered for analytical control, single analyte methods have been proposed, although the most useful ones in the real life cosmetic analysis are the multianalyte approaches. Copyright © 2016

  17. Measurement Properties of Instruments for Measuring of Lymphedema: Systematic Review.

    Science.gov (United States)

    Hidding, Janine T; Viehoff, Peter B; Beurskens, Carien H G; van Laarhoven, Hanneke W M; Nijhuis-van der Sanden, Maria W G; van der Wees, Philip J

    2016-12-01

    Lymphedema is a common complication of cancer treatment, resulting in swelling and subjective symptoms. Reliable and valid measurement of this side effect of medical treatment is important. The purpose of this study was to provide best evidence regarding which measurement instruments are most appropriate in measuring lymphedema in its different stages. The PubMed and Web of Science databases were used, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. Clinical studies on measurement instruments assessing lymphedema were reviewed using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) scoring instrument for quality assessment. Data on reliability, concurrent validity, convergent validity, sensitivity, specificity, applicability, and costs were extracted. Pooled data showed good intrarater intraclass correlation coefficients (ICCs) (.89) for bioimpedance spectroscopy (BIS) in the lower extremities and high intrarater and interrater ICCs for water volumetry, tape measurement, and perometry (.98-.99) in the upper extremities. In the upper extremities, the standard error of measurement was 3.6% (σ=0.7%) for water volumetry, 5.6% (σ=2.1%) for perometry, and 6.6% (σ=2.6%) for tape measurement. Sensitivity of tape measurement in the upper extremities, using different cutoff points, varied from 0.73 to 0.90, and specificity values varied from 0.72 to 0.78. No uniform definition of lymphedema was available, and a gold standard as a reference test was lacking. Items concerning risk of bias were study design, patient selection, description of lymphedema, blinding of test outcomes, and number of included participants. Measurement instruments with evidence for good reliability and validity were BIS, water volumetry, tape measurement, and perometry, where BIS can detect alterations in extracellular fluid in stage 1 lymphedema and the other measurement instruments can detect alterations in volume

  18. IOT Overview: IR Instruments

    Science.gov (United States)

    Mason, E.

    In this instrument review chapter the calibration plans of ESO IR instruments are presented and briefly reviewed focusing, in particular, on the case of ISAAC, which has been the first IR instrument at VLT and whose calibration plan served as prototype for the coming instruments.

  19. International Expert Team Concludes IAEA Peer Review of Finland's Regulatory Framework for Nuclear and Radiation Safety

    International Nuclear Information System (INIS)

    2012-01-01

    Full text: International safety experts today concluded a two-week International Atomic Energy Agency (IAEA) mission to review the regulatory framework for nuclear and radiation safety in Finland. In its preliminary report, the Integrated Regulatory Review Service (IRRS) mission team found that the Radiation and Nuclear Safety Authority of Finland (STUK) is a competent and highly credible regulator that is open and transparent and derives great strength from the technical competence of its staff. ''Finland's comprehensive regulatory framework allows STUK to operate in practice as an independent regulatory body,'' said team leader Philippe Jamet, a commissioner of the French regulatory body ASN. The mission was conducted at the request of the Government of Finland from 15-26 October. The team interviewed members of STUK and officials from various ministries, as well as key players in the Finnish safety framework. Such IRRS missions are peer reviews based on IAEA Safety Standards, not inspections or audits. The team was made up of 18 members from Bulgaria, Canada, the Czech Republic, France, Germany, Iceland, Ireland, Romania, the Russian Federation, South Africa, Slovakia, Slovenia, Spain, Sweden, the United Arab Emirates, the United Kingdom and the United States, as well as six IAEA staff members. 'The IRRS mission and preparation for it was a unique occasion that involved the whole organization, provided motivation for improvement of the safety framework in Finland and assists STUK review its mission', said Tero Varjoranta, Director General of STUK. The IRRS team identified a number of good practices and achievements, including: - STUK's excellence in its safety assessment of nuclear power plants and waste repositories, in particular its demonstration that long-term political commitment is a necessity to sustain the creation of a waste repository as well as its regulatory oversight of medical applications of radiation sources; and - STUK's excellent record in

  20. 76 FR 36927 - Determination of Regulatory Review Period for Purposes of Patent Extension; Fusilev, Levoleucovorin

    Science.gov (United States)

    2011-06-23

    ... drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA... after high-dose methotrexate therapy in osteosarcoma and is also indicated to diminish the toxicity and...

  1. Review of the Instruments Most Frequently Employed to Assess Tactics in Physical Education and Youth Sports

    Science.gov (United States)

    Arias, Jose L.; Castejon, Francisco Javier

    2012-01-01

    Investigators' increased interest in teaching game tactics requires generalizable assessment instruments that are appropriate to whatever is needed by the tactic. This literature review aims to provide information about the instruments most frequently used to assess tactics in youth sports. We found that very few studies used instruments that…

  2. Joint IAEA/NEA workshop proceedings on regulatory review of plant safety analysis - Abstracts, Summary and Conclusions

    International Nuclear Information System (INIS)

    Lacey, Derek; Drozd, Andrzej; Husarcek, Jan; Modro, Mike

    1999-01-01

    Based on the final discussion, the seminar was a valuable exchange of information and helpful in understanding the safety analysis and regulatory review issues. It gave a chance for some countries to see 'where they are' regulatory-wise with respect to other countries. There was a strong support for a follow-up workshop within the next two years. A general opinion expressed by most of the participants was that the suggested next seminar should be based more on an 'overall safety analysis' review rather than on very detailed presentations on specific issues. Also, there should be more discussions on Emergency Operating Procedures (EOPs) and emergency planning. In addition, to establish a 'common language', the development of a glossary of terms would be most helpful. In general, all of the participating countries are adapting regulatory and licensing practices previously developed by other countries. Such an approach allows to utilise and rely on a broad experience of countries with a well established nuclear power industry, strong regulatory organisation and licensing practices. Since there are obvious differences in engineering traditions and in countries' legal/regulatory frameworks, questions arise about how to reconcile these differences in adapting and developing practices suitable for a given country. It was advised as a good practice to identify from the very beginning what needs to be done and the goals to be accomplished not only in the perspective of safety and technical requirements but also in the context of the economical, political, legal and regulatory situation in a given country. There has to be a consistency in any approach, but one can never follow 'blindly' the others. It became quite obvious that the needs of countries with a big nuclear program are very different from those of 'small' countries. Adaptation of other countries' rules is a big effort in itself (e.g., Romania applying Canadian regulations). In addition, the French-German co

  3. Safety research and development in relation to regulatory review in the UKAEA

    International Nuclear Information System (INIS)

    Ablitt, J.F.

    1979-01-01

    The basic functions of the regulatory review process are defined in principle, and the need for constructive interplay between regulation on the one hand and research and development on the other, in order to avoid the dangers of being over-restrictive or too permissive, is established. A number of practical examples from operating experience are quoted, which illustrate the chosen theme. (author)

  4. The Development of an ASSA Module as an Auxiliary Tool for Assessment of Existing Plant Instrumentation and enhancement of the instruments performance

    International Nuclear Information System (INIS)

    Koo, Kil Mo; Kang, Kyung Ho; Ha, Kwang Soon; Cho, Young Ro; Cho, Young; Park, Rae Jun; Kim, Sang Baik; Kim, Hee Dong

    2007-04-01

    A review of a plant's accident management capabilities is one of the key elements in achieving regulatory closure of severe accident issues. During accidents, information and data from plant's instruments, as well as others sources, are essential for assessing the plant's status and response. Unlike for design basis accidents, there are inherently some uncertainties to instrumentation capabilities for severe accident conditions. There are many ways to obtain information during a severe accident. Moreover, precise measurements are not necessary. The redundancy and ruggedness of a plant's instrumentation provides considerable depth in the capability of existing designs. The circuit simulation analysis and diagnosis methods are used to assess instruments in detail when they give apparently abnormal readings. A new simulator, ASSA(abnormal signal simulator analysis), through an analysis of the important circuits modeling under severe accident conditions has been designed. It has three main functions which are a signal processing tool, an accident management tool, and an additional guide from the initial screen. In this paper, it can be simulated to the temperature characteristic analysis procedure of the ASSA through EQ data comparative method and using specific signal processing under severe accident condition

  5. A study on the regulatory approach of major technical issues

    Energy Technology Data Exchange (ETDEWEB)

    Chang, Keun Sun; Choi, J. T.; Kim, I. J. [Sunmoon Univ., Asan (Korea, Republic of); Lee, S. H.; Baek, W. P.; Yang, S. H. [Korea Association for Nuclear Technology, Taejon (Korea, Republic of)

    1998-06-15

    This project is to provide the regulatory direction of 4 major technical issues for the Korean Next Generation Reactors, which are parts of major technical issues resulted from the safety regulation R and D on the KNGR. The outstanding results are as follows : reliability of risk significant SSCs established during design stage must be maintained through the operating life of the plant, currently used classification method of plant conditions and safety requirement were reviewed, and a quantitative classification method is needed to be developed further, the basic regulatory directions are proposed for multiple failures such as SBO, TLOFW, multiple SGTR and ATWS, safety requirements are proposed for survivability/availability of severe accident mitigation design features by 5 items if basic requirements, selection of initial event, identification of available equipment and instruments, identification of environmental conditions and verification methods.

  6. The quantitative measurement of organizational culture in health care: a review of the available instruments.

    Science.gov (United States)

    Scott, Tim; Mannion, Russell; Davies, Huw; Marshall, Martin

    2003-06-01

    To review the quantitative instruments available to health service researchers who want to measure culture and cultural change. A literature search was conducted using Medline, Cinahl, Helmis, Psychlit, Dhdata, and the database of the King's Fund in London for articles published up to June 2001, using the phrase "organizational culture." In addition, all citations and the gray literature were reviewed and advice was sought from experts in the field to identify instruments not found on the electronic databases. The search focused on instruments used to quantify culture with a track record, or potential for use, in health care settings. For each instrument we examined the cultural dimensions addressed, the number of items for each questionnaire, the measurement scale adopted, examples of studies that had used the tool, the scientific properties of the instrument, and its strengths and limitations. Thirteen instruments were found that satisfied our inclusion criteria, of which nine have a track record in studies involving health care organizations. The instruments varied considerably in terms of their grounding in theory, format, length, scope, and scientific properties. A range of instruments with differing characteristics are available to researchers interested in organizational culture, all of which have limitations in terms of their scope, ease of use, or scientific properties. The choice of instrument should be determined by how organizational culture is conceptualized by the research team, the purpose of the investigation, intended use of the results, and availability of resources.

  7. The Preliminary Review for the Cross-Cutting Issues in the US Nuclear Regulatory Inspection Framework

    International Nuclear Information System (INIS)

    Lee, Yong Suk; Jung, Dae Wook; Cho, Nam Chul

    2008-01-01

    The research for the development of risk-informed and performance-based regulatory inspection is ongoing in KINS. In the USNRC, the cross-cutting issue is one of the main components the risk-informed and performance-based regulatory inspection process as shown in figure 1, which is named as ROP (Reactor Oversight Process). The following three cross-cutting areas implicitly affect all of the safety cornerstones in ROP. In this study, the preliminary review for the inspection practices of cross-cutting issues in the US and Korean safety regulatory system were performed. The elements of the cross-cutting issues were recently modified to emphasize the importance of safety culture, and the graded approach was applied for the inspection of cross-cutting issues in USNRC. The graded approach for the inspection of cross-cutting issues will be also needed to Korean safety regulatory system in the future

  8. The Preliminary Review for the Cross-Cutting Issues in the US Nuclear Regulatory Inspection Framework

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Yong Suk; Jung, Dae Wook [Future and Challenges Inc., Seoul (Korea, Republic of); Cho, Nam Chul [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2008-10-15

    The research for the development of risk-informed and performance-based regulatory inspection is ongoing in KINS. In the USNRC, the cross-cutting issue is one of the main components the risk-informed and performance-based regulatory inspection process as shown in figure 1, which is named as ROP (Reactor Oversight Process). The following three cross-cutting areas implicitly affect all of the safety cornerstones in ROP. In this study, the preliminary review for the inspection practices of cross-cutting issues in the US and Korean safety regulatory system were performed. The elements of the cross-cutting issues were recently modified to emphasize the importance of safety culture, and the graded approach was applied for the inspection of cross-cutting issues in USNRC. The graded approach for the inspection of cross-cutting issues will be also needed to Korean safety regulatory system in the future.

  9. A Review on Regulatory Enforcement Policy

    International Nuclear Information System (INIS)

    Lim, Ji Han; Lee, Kyung Joo; Choi, Young Sung

    2017-01-01

    This paper examine the meaning and principle of enforcement through examples from other countries. Regulatory enforcement is the last stage of safety regulation and how it is exercised when one failing to meet regulatory requirements can have significant ripple effect across the industry. Thus, right philosophy and principle should be established. It is not recommended to emphasize neither deterrence approach nor behavior modification approach. This should be also taken into consideration when setting up the principle and system of regulatory enforcement. In the process of Vienna Declaration, Europe and the U.S showed the fundamental differences in their approaches to safety regulation. Considering this, it is required to remain cautious at all times on what to be improved in the aspect of internal consistency within our system and also in the aspect of procedure.

  10. Regulatory challenges in the review of data from global clinical trials: the PMDA perspective.

    Science.gov (United States)

    Asano, K; Tanaka, A; Sato, T; Uyama, Y

    2013-08-01

    Regulatory agencies face challenges in reviewing data from global clinical trials (GCTs) in the era of globalization of drug development. One major challenge is consideration of ethnic factors in evaluating GCT data so as to extrapolate foreign population data to one's own national population. Here, we present the Pharmaceuticals and Medical Devices Agency (PMDA) perspective in reviewing GCT data in new drug applications (NDAs) and discuss future challenges for new drug approval.

  11. Theory, Instrumentation and Applications of Magnetoelastic Resonance Sensors: A Review

    Science.gov (United States)

    Grimes, Craig A.; Roy, Somnath C.; Rani, Sanju; Cai, Qingyun

    2011-01-01

    Thick-film magnetoelastic sensors vibrate mechanically in response to a time varying magnetic excitation field. The mechanical vibrations of the magnetostrictive magnetoelastic material launch, in turn, a magnetic field by which the sensor can be monitored. Magnetic field telemetry enables contact-less, remote-query operation that has enabled many practical uses of the sensor platform. This paper builds upon a review paper we published in Sensors in 2002 (Grimes, C.A.; et al. Sensors 2002, 2, 294–313), presenting a comprehensive review on the theory, operating principles, instrumentation and key applications of magnetoelastic sensing technology. PMID:22163768

  12. Theory, Instrumentation and Applications of Magnetoelastic Resonance Sensors: A Review

    Directory of Open Access Journals (Sweden)

    Craig A. Grimes

    2011-03-01

    Full Text Available Thick-film magnetoelastic sensors vibrate mechanically in response to a time varying magnetic excitation field. The mechanical vibrations of the magnetostrictive magnetoelastic material launch, in turn, a magnetic field by which the sensor can be monitored. Magnetic field telemetry enables contact-less, remote-query operation that has enabled many practical uses of the sensor platform. This paper builds upon a review paper we published in Sensors in 2002 (Grimes, C.A.; et al. Sensors 2002, 2, 294-313, presenting a comprehensive review on the theory, operating principles, instrumentation and key applications of magnetoelastic sensing technology.

  13. The measurement of collaboration within healthcare settings: a systematic review of measurement properties of instruments.

    Science.gov (United States)

    Walters, Stephen John; Stern, Cindy; Robertson-Malt, Suzanne

    2016-04-01

    There is a growing call by consumers and governments for healthcare to adopt systems and approaches to care to improve patient safety. Collaboration within healthcare settings is an important factor for improving systems of care. By using validated measurement instruments a standardized approach to assessing collaboration is possible, otherwise it is only an assumption that collaboration is occurring in any healthcare setting. The objective of this review was to evaluate and compare measurement properties of instruments that measure collaboration within healthcare settings, specifically those which have been psychometrically tested and validated. Participants could be healthcare professionals, the patient or any non-professional who contributes to a patient's care, for example, family members, chaplains or orderlies. The term participant type means the designation of any one participant; for example 'nurse', 'social worker' or 'administrator'. More than two participant types was mandatory. The focus of this review was the validity of tools used to measure collaboration within healthcare settings. The types of studies considered for inclusion were validation studies, but quantitative study designs such as randomized controlled trials, controlled trials and case studies were also eligible for inclusion. Studies that focused on Interprofessional Education, were published as an abstract only, contained patient self-reporting only or were not about care delivery were excluded. The outcome of interest was validation and interpretability of the instrument being assessed and included content validity, construct validity and reliability. Interpretability is characterized by statistics such as mean and standard deviation which can be translated to a qualitative meaning. The search strategy aimed to find both published and unpublished studies. A three-step search strategy was utilized in this review. The databases searched included PubMed, CINAHL, Embase, Cochrane Central

  14. Review Paper: Review of Instrumentation for Irradiation Testing of Nuclear Fuels and Materials

    International Nuclear Information System (INIS)

    Kim, Bong Goo; Rempe, Joy L.; Villard, Jean-Francois; Solstadd, Steinar

    2011-01-01

    Over 50 years of nuclear fuels and materials irradiation testing has led to many countries developing significant improvements in instrumentation to monitor physical parameters and to control the test conditions in material test reactors (MTRs). Recently, there is increased interest to irradiate new materials and reactor fuels for advanced pressurized water reactors and Gen-IV reactor systems, such as sodium-cooled fast reactors, very high temperature reactors, supercritical water-cooled reactors, and gas-cooled fast reactors. This review paper documents the current state of instrumentation technologies in MTRs in the world and summarizes ongoing research efforts to deploy new sensors. As described in this paper, a wide range of sensors is available to measure key parameters of interest during fuels and materials irradiations in MTRs. Ongoing development efforts focus on providing MTR users a wider range of parameter measurements with smaller, higher accuracy sensors.

  15. Strengthening of the nuclear safety regulatory body. Field evaluation review

    International Nuclear Information System (INIS)

    1996-10-01

    As a result of a request from the Preparation Committee of the Nuclear Regulatory Authority (NRA) in 1992, and as recommended by the CEC/RAMG (Commission of European Communities/Regulatory Assistance Management Group) and the Agency mission in July 1993 to the Slovak Republic, the project SLR/9/005 was approved in 1993 as a model project for the period 1994-1996. Current budge is $401,340 and disbursements to date amount to $312,873. The project time schedule has been extended to 1997. The major conclusions of this evaluation are as follows: The project responded to an urgent national need, as well as to a statutory mandate of the Agency, and was adequately co-ordinated with other international assistance programmes to NRA. The project was designed as a structured programme of assistance by means of expert missions, scientific visits and a limited amount of equipment, acting upon several key areas of NRA regulatory responsibilities. Agency assistance was provided in a timely manner. A high concentration of expert missions was noticed at the initial stages of the project, which posed some managements problems. This was corrected to some extent in the course of implementation. Additionally, some overlapping of expert mission recommendations suggests that improvements are needed in the design of such missions. The exposure to international regulatory practice and expertise has resulted in substantial developments of NRA, both in organizational and operational terms. The project can claim to have contributed to NRA having gained governmental and international confidence. NRA's role in the safety assessment of Bohunice V1 reconstruction, as well as in Bohunice V2 safety review, Bohunice A1 decommissioning and in informing the public, also points at the success achieved by the project. The institutional and financial support of the Government contributed decisively to the project achievements. (author). Figs, tabs

  16. Novel seismic instrumentation for nuclear power plants

    International Nuclear Information System (INIS)

    Bolleter, W.; Savary, C.

    1998-01-01

    Conforming to the latest issues of the Nuclear Regulatory Commission Regulatory Guide, a novel hardware and software solution for seismic instrumentation is presented. Both instrumentation and PC-based data evaluation software for post-earthquake actions are type-tested and approved by the German TUeV. Reference installations replacing obsolete analog instrumentation were successfully completed and are presented. The instrumentation consists of highly linear, solid-state capacitive accelerometers as well as digital recorders storing the signals from the sensors in situ. These recorders are linked in a star-topology network to a central unit that permanently communicates with them via fiber-optic cable or current-loop links. The central unit is responsible for alerting and synchronizes all recorders which otherwise act autonomously. Data evaluation is handled by a PC-based software package. It includes automatic data evaluation after earthquakes (batch mode), interactive data evaluation software for detailed data analysis, and software tools for remote operation, maintenance and data storage. (author)

  17. Nuclear Regulatory Commission staff development of the license application review plan for a high-level radioactive waste repository

    International Nuclear Information System (INIS)

    Johnson, R.L.; Holonich, J.J.; Lee, M.P.; Delligatti, M.S.

    1993-01-01

    The Nuclear Regulatory Commission staff has recently started a new initiative to develop the License Application Review Plan (LARP) which the staff will use in its reviews of the U.S. Department of Energy's (DOE's) license application (LA) for a geologic repository for the disposal of high-level radioactive waste (HLW). This paper describes the staff's approach for developing the LARP, the development schedule and current status, the organization and content of the LARP, and the staff's LA review strategy. Therefore, it gives a preview of the draft LARP which will be made available in late 1993. It also describes how the LARP will be used as guidance to the staff in conducting reviews of regulatory and technical issues important to the licensing of a geologic repository. Finally, the benefits to the NRC staff, DOE, and other parties are discussed

  18. Special committee review of the Nuclear Regulatory Commission's severe accident risks report (NUREG--1150)

    International Nuclear Information System (INIS)

    Kouts, H.J.C.; Apostolakis, G.; Kastenberg, W.E.; Birkhofer, E.H.A.; Hoegberg, L.G.; LeSage, L.G.; Rasmussen, N.C.; Teague, H.J.; Taylor, J.J.

    1990-08-01

    In April 1989, the Nuclear Regulatory Commission's (NRC) Office of Nuclear Regulatory Research (RES) published a draft report ''Severe Accident Risks: An Assessment for Five US Nuclear Power Plants,'' NUREG-1150. This report updated, extended and improved upon the information presented in the 1974 ''Reactor Safety Study,'' WASH-1400. Because the information in NUREG-1150 will play a significant role in implementing the NRC's Severe Accident Policy, its quality and credibility are of critical importance. Accordingly, the Commission requested that the RES conduct a peer review of NUREG-1150 to ensure that the methods, safety insights and conclusions presented are appropriate and adequately reflect the current state of knowledge with respect to reactor safety. To this end, RES formed a special committee in June of 1989 under the provisions of the Federal Advisory Committee Act. The Committee, composed of a group of recognized national and international experts in nuclear reactor safety, was charged with preparing a report reflecting their review of NUREG-1150 with respect to the adequacy of the methods, data, analysis and conclusions it set forth. The report which precedes reflects the results of this peer review

  19. Statistical challenges in a regulatory review of cardiovascular and CNS clinical trials.

    Science.gov (United States)

    Hung, H M James; Wang, Sue-Jane; Yang, Peiling; Jin, Kun; Lawrence, John; Kordzakhia, George; Massie, Tristan

    2016-01-01

    There are several challenging statistical problems identified in the regulatory review of large cardiovascular (CV) clinical outcome trials and central nervous system (CNS) trials. The problems can be common or distinct due to disease characteristics and the differences in trial design elements such as endpoints, trial duration, and trial size. In schizophrenia trials, heavy missing data is a big problem. In Alzheimer trials, the endpoints for assessing symptoms and the endpoints for assessing disease progression are essentially the same; it is difficult to construct a good trial design to evaluate a test drug for its ability to slow the disease progression. In CV trials, reliance on a composite endpoint with low event rate makes the trial size so large that it is infeasible to study multiple doses necessary to find the right dose for study patients. These are just a few typical problems. In the past decade, adaptive designs were increasingly used in these disease areas and some challenges occur with respect to that use. Based on our review experiences, group sequential designs (GSDs) have borne many successful stories in CV trials and are also increasingly used for developing treatments targeting CNS diseases. There is also a growing trend of using more advanced unblinded adaptive designs for producing efficacy evidence. Many statistical challenges with these kinds of adaptive designs have been identified through our experiences with the review of regulatory applications and are shared in this article.

  20. Instrumentation in Developing Chlorophyll Fluorescence Biosensing: A Review

    Science.gov (United States)

    Fernandez-Jaramillo, Arturo A.; Duarte-Galvan, Carlos; Contreras-Medina, Luis M.; Torres-Pacheco, Irineo; de J. Romero-Troncoso, Rene; Guevara-Gonzalez, Ramon G.; Millan-Almaraz, Jesus R.

    2012-01-01

    Chlorophyll fluorescence can be defined as the red and far-red light emitted by photosynthetic tissue when it is excited by a light source. This is an important phenomenon which permits investigators to obtain important information about the state of health of a photosynthetic sample. This article reviews the current state of the art knowledge regarding the design of new chlorophyll fluorescence sensing systems, providing appropriate information about processes, instrumentation and electronic devices. These types of systems and applications can be created to determine both comfort conditions and current problems within a given subject. The procedure to measure chlorophyll fluorescence is commonly split into two main parts; the first involves chlorophyll excitation, for which there are passive or active methods. The second part of the procedure is to closely measure the chlorophyll fluorescence response with specialized instrumentation systems. Such systems utilize several methods, each with different characteristics regarding to cost, resolution, ease of processing or portability. These methods for the most part include cameras, photodiodes and satellite images. PMID:23112686

  1. Instrumentation in Developing Chlorophyll Fluorescence Biosensing: A Review

    Directory of Open Access Journals (Sweden)

    Jesus R. Millan-Almaraz

    2012-08-01

    Full Text Available Chlorophyll fluorescence can be defined as the red and far-red light emitted by photosynthetic tissue when it is excited by a light source. This is an important phenomenon which permits investigators to obtain important information about the state of health of a photosynthetic sample. This article reviews the current state of the art knowledge regarding the design of new chlorophyll fluorescence sensing systems, providing appropriate information about processes, instrumentation and electronic devices. These types of systems and applications can be created to determine both comfort conditions and current problems within a given subject. The procedure to measure chlorophyll fluorescence is commonly split into two main parts; the first involves chlorophyll excitation, for which there are passive or active methods. The second part of the procedure is to closely measure the chlorophyll fluorescence response with specialized instrumentation systems. Such systems utilize several methods, each with different characteristics regarding to cost, resolution, ease of processing or portability. These methods for the most part include cameras, photodiodes and satellite images.

  2. Review of modern instrumentation for magnetic measurements at high pressure and low temperature

    International Nuclear Information System (INIS)

    Wang, X.; Kamenev, K.V.

    2015-01-01

    High-pressure magnetic susceptibility experiments can provide insights into the changes in magnetic behavior and electric properties which can accompany extreme compressions of material. Instrumentation plays an important role in the experimental work in this field since 1990s. Here we present a comprehensive review of the high-pressure instrumentation development for magnetic measurement from the engineering perspective in the last 20 years. Suitable nonmagnetic materials for high pressure cell are introduced initially. Then we focus on the existing cells developed for magnetic property measurement system (MPMS) SQUID magnetometer from Quantum Design (USA). Two categories of high pressure cells for this system are discussed in detail respectively. Some high pressure cells with built-in magnetic measurement system are also reviewed

  3. Measurement properties of instruments assessing permanent functional impairment of the spine: a systematic review protocol

    Science.gov (United States)

    Trask, Catherine M; Boden, Catherine; Bath, Brenna; Hendrick, Paul; Clay, Lynne; Zeng, Xiaoke; Milosavljevic, Stephan

    2018-01-01

    Introduction Permanent functional impairment (PFI) of the spine is a rating system used by compensation authorities, such as workers compensation boards, to establish an appropriate level of financial compensation for persistent loss of function. Determination of PFI of the spine is commonly based on the assessment of spinal movement combined with other measures of physical and functional impairments; however, the reliability and validity of the measurement instruments used for these evaluations have yet to be established. The aim of this study is to systematically review and synthesise the literature concerning measurement properties of the various and different instruments used for assessing PFI of the spine. Methods Three conceptual groups of terms (1) PFI, (2) spinal disorder and (3) measurement properties will be combined to search Medline, EMBASE, CINAHL, Web of Science, Scopus, PEDro, OTSeeker and Health and Safety Science Abstracts. We will examine peer-reviewed, full-text articles over the full available date range. Two reviewers will independently screen citations (title, abstract and full text) and perform data extraction. Included studies will be appraised as to their methodological quality using the COnsensus-based Standards for the selection of health Measurement INstruments criteria. Findings will be summarised and presented descriptively, with meta-analysis pursued as appropriate. Ethics and dissemination This review will summarise the current level of evidence of measurement properties of instruments used for assessing PFI of the spine. Findings of this review may be applicable to clinicians, policy-makers, workers’ compensation boards, other insurers and health and safety organisations. The findings will likely provide a foundation and direction for future research priorities for assessing spinal PFI. PROSPERO registration number CRD42017060390. PMID:29374671

  4. 76 FR 15322 - Determination of Regulatory Review Period for Purposes of Patent Extension; VPRIV

    Science.gov (United States)

    2011-03-21

    ..., medical device, food additive, or color additive) was subject to regulatory review by FDA before the item... therapy for pediatric and adult patients with type 1 Gaucher Disease. Subsequent to this approval, the...,138,262) from Shire Human Genetic Therapies, Inc., and the Patent and Trademark Office requested FDA's...

  5. Content Validity of Patient-Reported Outcome Instruments used with Pediatric Patients with Facial Differences: A Systematic Review.

    Science.gov (United States)

    Wickert, Natasha M; Wong Riff, Karen W Y; Mansour, Mark; Forrest, Christopher R; Goodacre, Timothy E E; Pusic, Andrea L; Klassen, Anne F

    2018-01-01

    Objective The aim of this systematic review was to identify patient-reported outcome (PRO) instruments used in research with children/youth with conditions associated with facial differences to identify the health concepts measured. Design MEDLINE, EMBASE, CINAHL, and PsycINFO were searched from 2004 to 2016 to identify PRO instruments used in acne vulgaris, birthmarks, burns, ear anomalies, facial asymmetries, and facial paralysis patients. We performed a content analysis whereby the items were coded to identify concepts and categorized as positive or negative content or phrasing. Results A total of 7,835 articles were screened; 6 generic and 11 condition-specific PRO instruments were used in 96 publications. Condition-specific instruments were for acne (four), oral health (two), dermatology (one), facial asymmetries (two), microtia (one), and burns (one). The PRO instruments provided 554 items (295 generic; 259 condition specific) that were sorted into 4 domains, 11 subdomains, and 91 health concepts. The most common domain was psychological (n = 224 items). Of the identified items, 76% had negative content or phrasing (e.g., "Because of the way my face looks I wish I had never been born"). Given the small number of items measuring facial appearance (n = 19) and function (n = 22), the PRO instruments reviewed lacked content validity for patients whose condition impacted facial function and/or appearance. Conclusions Treatments can change facial appearance and function. This review draws attention to a problem with content validity in existing PRO instruments. Our team is now developing a new PRO instrument called FACE-Q Kids to address this problem.

  6. 77 FR 26016 - Determination of Regulatory Review Period for Purposes of Patent Extension; Alair Bronchial...

    Science.gov (United States)

    2012-05-02

    ... approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period... asthma is not well controlled [[Page 26017

  7. Validity of instruments to measure physical activity may be questionable due to a lack of conceptual frameworks: a systematic review

    Science.gov (United States)

    2011-01-01

    Background Guidance documents for the development and validation of patient-reported outcomes (PROs) advise the use of conceptual frameworks, which outline the structure of the concept that a PRO aims to measure. It is unknown whether currently available PROs are based on conceptual frameworks. This study, which was limited to a specific case, had the following aims: (i) to identify conceptual frameworks of physical activity in chronic respiratory patients or similar populations (chronic heart disease patients or the elderly) and (ii) to assess whether the development and validation of PROs to measure physical activity in these populations were based on a conceptual framework of physical activity. Methods Two systematic reviews were conducted through searches of the Medline, Embase, PsycINFO, and Cinahl databases prior to January 2010. Results In the first review, only 2 out of 581 references pertaining to physical activity in the defined populations provided a conceptual framework of physical activity in COPD patients. In the second review, out of 103 studies developing PROs to measure physical activity or related constructs, none were based on a conceptual framework of physical activity. Conclusions These findings raise concerns about how the large body of evidence from studies that use physical activity PRO instruments should be evaluated by health care providers, guideline developers, and regulatory agencies. PMID:21967887

  8. Regulatory mechanisms for absenteeism in the health sector: a systematic review of strategies and their implementation

    Directory of Open Access Journals (Sweden)

    Kisakye AN

    2016-11-01

    Full Text Available Angela N Kisakye,1 Raymond Tweheyo,1 Freddie Ssengooba,1 George W Pariyo,2 Elizeus Rutebemberwa,1 Suzanne N Kiwanuka1 1Department of Health Policy Planning and Management, Makerere University School of Public Health, Kampala, Uganda; 2Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA Background: A systematic review was undertaken to identify regulatory mechanisms aimed at mitigating health care worker absenteeism, to describe where and how they have been implemented as well as their possible effects. The goal was to propose potential policy options for managing the problem of absenteeism among human resources for health in low- and middle-income countries. Mechanisms described in this review are at the local workplace and broader national policy level. Methods: A comprehensive online search was conducted on EMBASE, CINAHL, PubMed, Google Scholar, Google, and Social Science Citation Index using MEDLINE search terms. Retrieved studies were uploaded onto reference manager and screened by two independent reviewers. Only publications in English were included. Data were extracted and synthesized according to the objectives of the review. Results: Twenty six of the 4,975 published articles retrieved were included. All were from high-income countries and covered all cadres of health workers. The regulatory mechanisms and possible effects include 1 organizational-level mechanisms being reported as effective in curbing absenteeism in low- and middle-income countries (LMICs; 2 prohibition of private sector activities in LMICs offering benefits but presenting a challenge for the government to monitor the health workforce; 3 contractual changes from temporary to fixed posts having been associated with no reduction in absenteeism and not being appropriate for LMICs; 4 multifaceted work interventions being implemented in most settings; 5 the possibility of using financial and incentive regulatory mechanisms

  9. Validation of online psychometric instruments for common mental health disorders: a systematic review.

    Science.gov (United States)

    van Ballegooijen, Wouter; Riper, Heleen; Cuijpers, Pim; van Oppen, Patricia; Smit, Johannes H

    2016-02-25

    Online questionnaires for measuring common mental health disorders such as depression and anxiety disorders are increasingly used. The psychometrics of several pen-and-paper questionnaires have been re-examined for online use and new online instruments have been developed and tested for validity as well. This study aims to review and synthesise the literature on this subject and provide a framework for future research. We searched Medline and PsycINFO for psychometric studies on online instruments for common mental health disorders and extracted the psychometric data. Studies were coded and assessed for quality by independent raters. We included 56 studies on 62 online instruments. For common instruments such as the CES-D, MADRS-S and HADS there is mounting evidence for adequate psychometric properties. Further results are scattered over different instruments and different psychometric characteristics. Few studies included patient populations. We found at least one online measure for each of the included mental health disorders and symptoms. A small number of online questionnaires have been studied thoroughly. This study provides an overview of online instruments to refer to when choosing an instrument for assessing common mental health disorders online, and can structure future psychometric research.

  10. 77 FR 26768 - Determination of Regulatory Review Period for Purposes of Patent Extension; PROLIA

    Science.gov (United States)

    2012-05-07

    ... postmenopausal women with osteoporosis at high risk for fracture. Subsequent to this approval, the Patent and..., FDA-2010-E-0660, and FDA-2010-E-0659] Determination of Regulatory Review Period for Purposes of Patent... the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which...

  11. Computer software review procedures

    International Nuclear Information System (INIS)

    Mauck, J.L.

    1993-01-01

    This article reviews the procedures which are used to review software written for computer based instrumentation and control functions in nuclear facilities. The utilization of computer based control systems is becoming much more prevalent in such installations, in addition to being retrofit into existing systems. Currently, the Nuclear Regulatory System uses Regulatory Guide 1.152, open-quotes Criteria for Programmable Digital Computer System Software in Safety-Related Systems of Nuclear Power Plantsclose quotes and ANSI/IEEE-ANS-7-4.3.2-1982, open-quotes Application Criteria for Programmable Digital Computer Systems in Safety Systems of Nuclear Power Generating Stationsclose quotes for guidance when performing reviews of digital systems. There is great concern about the process of verification and validation of these codes, so when inspections are done of such systems, inspectors examine very closely the processes which were followed in developing the codes, the errors which were detected, how they were found, and the analysis which went into tracing down the causes behind the errors to insure such errors were not propagated again in the future

  12. Cryogenic instrumentation with cold electronics-A review

    International Nuclear Information System (INIS)

    Rao, M.G.; Scurlock, R.G.

    1986-01-01

    The low level signals from cryogenic sensors and transducers are usually carried to the electronic signal conditioning and data handling systems at ambient temperatures by long electrical leads running from the cyrogenic environment to ambient. There are many applications, outside those using superconducting devices, in which there are advantages to be gained by placing part or all of the electronic system in the cryogenic environment adjacent to the measuring point. This paper discusses the requirements for an ideal cold electronic instrumentation system and then reviews the present state of the art in relation to off-the-shelf electronic components, devices and integrated circuits, and the published literature. The integration of sensors/transducers with cold electronics is discussed and areas for development are outlined

  13. Regulatory analysis for amendments to regulations for the environmental review for renewal of nuclear power plant operating licenses. Final report

    International Nuclear Information System (INIS)

    1996-05-01

    This regulatory analysis provides the supporting information for a proposed rule that will amend the Nuclear Regulatory Commission's environmental review requirements for applications for renewal of nuclear power plant operating licenses. The objective of the proposed rulemaking is to improve regulatory efficiency by providing for the generic evaluation of certain environmental impacts associated with nuclear plant license renewal. After considering various options, the staff identified and analyzed two major alternatives. With Alternative A, the existing regulations would not be amended. This option requires that environmental reviews be performed under the existing regulations. Alternative B is to assess, on a generic basis, the environmental impacts of renewing the operating license of individual nuclear power plants, and define the issues that will need to be further analyzed on a case-by-case basis. In addition, Alternative B removes from NRC's review certain economics-related issues. The findings of this assessment are to be codified in 10 CFR 51. The staff has selected Alternative B as the preferred alternative

  14. Measurement properties of adult quality-of-life measurement instruments for eczema: protocol for a systematic review.

    Science.gov (United States)

    Apfelbacher, Christian J; Heinl, Daniel; Prinsen, Cecilia A C; Deckert, Stefanie; Chalmers, Joanne; Ofenloch, Robert; Humphreys, Rosemary; Sach, Tracey; Chamlin, Sarah; Schmitt, Jochen

    2015-04-16

    Eczema is a common chronic or chronically relapsing skin disease that has a substantial impact on quality of life (QoL). By means of a consensus-based process, the Harmonising Outcome Measures in Eczema (HOME) initiative has identified QoL as one of the four core outcome domains to be assessed in all eczema trials (Allergy 67(9):1111-7, 2012). Various measurement instruments exist to measure QoL in adults with eczema, but there is a great variability in both content and quality (for example, reliability and validity) of the instruments used, and it is not always clear if the best instrument is being used. Therefore, the aim of the proposed research is a comprehensive systematic assessment of the measurement properties of the existing measurement instruments that were developed and/or validated for the measurement of patient-reported QoL in adults with eczema. This study is a systematic review of the measurement properties of patient-reported measures of QoL developed and/or validated for adults with eczema. Medline via PubMed and EMBASE will be searched using a selection of relevant search terms. Eligible studies will be primary empirical studies evaluating, describing, or comparing measurement properties of QoL instruments for adult patients with eczema. Eligibility assessment and data abstraction will be performed independently by two reviewers. Evidence tables will be generated for study characteristics, instrument characteristics, measurement properties, and interpretability. The quality of the measurement properties will be assessed using predefined criteria. Methodological quality of studies will be assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. A best evidence synthesis will be undertaken if more than one study has investigated a particular measurement property. The proposed systematic review will produce a comprehensive assessment of measurement properties of existing QoL instruments in

  15. Fair value accounting for financial instruments: some implications for bank regulation

    OpenAIRE

    Wayne Landsman

    2006-01-01

    I identify issues that bank regulators need to consider if fair value accounting is used for determining bank regulatory capital and when making regulatory decisions. In financial reporting, US and international accounting standard setters have issued several disclosure and measurement and recognition standards for financial instruments and all indications are that both standard setters will mandate recognition of all financial instruments at fair value. To help identify important issues for ...

  16. Measurement properties of instruments assessing permanent functional impairment of the spine: a systematic review protocol.

    Science.gov (United States)

    Goes, Suelen Meira; Trask, Catherine M; Boden, Catherine; Bath, Brenna; Ribeiro, Daniel Cury; Hendrick, Paul; Clay, Lynne; Zeng, Xiaoke; Milosavljevic, Stephan

    2018-01-27

    Permanent functional impairment (PFI) of the spine is a rating system used by compensation authorities, such as workers compensation boards, to establish an appropriate level of financial compensation for persistent loss of function. Determination of PFI of the spine is commonly based on the assessment of spinal movement combined with other measures of physical and functional impairments; however, the reliability and validity of the measurement instruments used for these evaluations have yet to be established. The aim of this study is to systematically review and synthesise the literature concerning measurement properties of the various and different instruments used for assessing PFI of the spine. Three conceptual groups of terms (1) PFI, (2) spinal disorder and (3) measurement properties will be combined to search Medline, EMBASE, CINAHL, Web of Science, Scopus, PEDro, OTSeeker and Health and Safety Science Abstracts. We will examine peer-reviewed, full-text articles over the full available date range. Two reviewers will independently screen citations (title, abstract and full text) and perform data extraction. Included studies will be appraised as to their methodological quality using the COnsensus-based Standards for the selection of health Measurement INstruments criteria. Findings will be summarised and presented descriptively, with meta-analysis pursued as appropriate. This review will summarise the current level of evidence of measurement properties of instruments used for assessing PFI of the spine. Findings of this review may be applicable to clinicians, policy-makers, workers' compensation boards, other insurers and health and safety organisations. The findings will likely provide a foundation and direction for future research priorities for assessing spinal PFI. CRD42017060390. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise

  17. Calibration of dosemeters and survey instruments for photon

    International Nuclear Information System (INIS)

    Alamares, A.L.; Caseria, E.S.

    1995-01-01

    The Philippine Nuclear Research Institute (PNRI), the country's regulatory agency, through its Radiation Protection Unit of the Nuclear Regulations Licensing and Safeguard Division provides the calibration services of nuclear instruments used by various institutions. The periodic calibration and standardization of radiation and protection survey instruments are done to insure correct and valid radiation readings. It is also a regulatory requirement for radiation workers to use only operable and precalibrated survey instruments for their work with radioactive materials. The PNRI maintains and operates the Secondary Standard Dosimetry Laboratory (SSDL). It provides the periodic calibration and standardization of radiation monitoring and protection survey instruments, and also the radiological hazard and performance evaluation surveys of radiotherapy facilities and others. For the calibration of survey instruments, the standard sources of Cs-137 and Co-60 are used. The calibration procedures for survey meters and pocket dosimeters are explained. The clients served are shown. The personnel dosimetry using film badges, the application of ICRU operational quantities, and the problems encountered and recommendations are reported. (K.I.)

  18. Implementation outcome assessment instruments used in physical healthcare settings and their measurement properties: a systematic review protocol.

    Science.gov (United States)

    Khadjesari, Zarnie; Vitoratou, Silia; Sevdalis, Nick; Hull, Louise

    2017-10-08

    Over the past 10 years, research into methods that promote the uptake, implementation and sustainability of evidence-based interventions has gathered pace. However, implementation outcomes are defined in different ways and assessed by different measures; the extent to which these measures are valid and reliable is unknown. The aim of this systematic review is to identify and appraise studies that assess the measurement properties of quantitative implementation outcome instruments used in physical healthcare settings, to advance the use of precise and accurate measures. The following databases will be searched from inception to March 2017: MEDLINE, EMBASE, PsycINFO, CINAHL and the Cochrane Library. Grey literature will be sought via HMIC, OpenGrey, ProQuest for theses and Web of Science Conference Proceedings Citation Index-Science. Reference lists of included studies and relevant reviews will be hand searched. Three search strings will be combined to identify eligible studies: (1) implementation literature, (2) implementation outcomes and (3) measurement properties. Screening of titles, abstracts and full papers will be assessed for eligibility by two reviewers independently and any discrepancies resolved via consensus with the wider team. The methodological quality of the studies will be assessed using the COnsensus-based Standards for the selection of health Measurement INstruments checklist. A set of bespoke criteria to determine the quality of the instruments will be used, and the relationship between instrument usability and quality will be explored. Ethical approval is not necessary for systematic review protocols. Researchers and healthcare professionals can use the findings of this systematic review to guide the selection of implementation outcomes instruments, based on their psychometric quality, to assess the impact of their implementation efforts. The findings will also provide a useful guide for reviewers of papers and grants to determine the

  19. Implementation outcome assessment instruments used in physical healthcare settings and their measurement properties: a systematic review protocol

    Science.gov (United States)

    Vitoratou, Silia; Sevdalis, Nick; Hull, Louise

    2017-01-01

    Introduction Over the past 10 years, research into methods that promote the uptake, implementation and sustainability of evidence-based interventions has gathered pace. However, implementation outcomes are defined in different ways and assessed by different measures; the extent to which these measures are valid and reliable is unknown. The aim of this systematic review is to identify and appraise studies that assess the measurement properties of quantitative implementation outcome instruments used in physical healthcare settings, to advance the use of precise and accurate measures. Methods and analysis The following databases will be searched from inception to March 2017: MEDLINE, EMBASE, PsycINFO, CINAHL and the Cochrane Library. Grey literature will be sought via HMIC, OpenGrey, ProQuest for theses and Web of Science Conference Proceedings Citation Index-Science. Reference lists of included studies and relevant reviews will be hand searched. Three search strings will be combined to identify eligible studies: (1) implementation literature, (2) implementation outcomes and (3) measurement properties. Screening of titles, abstracts and full papers will be assessed for eligibility by two reviewers independently and any discrepancies resolved via consensus with the wider team. The methodological quality of the studies will be assessed using the COnsensus-based Standards for the selection of health Measurement INstruments checklist. A set of bespoke criteria to determine the quality of the instruments will be used, and the relationship between instrument usability and quality will be explored. Ethics and dissemination Ethical approval is not necessary for systematic review protocols. Researchers and healthcare professionals can use the findings of this systematic review to guide the selection of implementation outcomes instruments, based on their psychometric quality, to assess the impact of their implementation efforts. The findings will also provide a useful guide for

  20. A systematic review of instruments to measure depressive symptoms in patients with schizophrenia

    NARCIS (Netherlands)

    Lako, Irene M.; Bruggeman, R.; Knegtering, H.; Wiersma, D.; Schoevers, R. A.; Slooff, C. J.; Taxis, K.

    Background: Depressive symptoms require accurate recognition and monitoring in clinical practice of patients with schizophrenia. Depression instruments developed for use in depressed patients may not discriminate depressive symptoms from negative psychotic symptoms. Objective: We reviewed depression

  1. Review of risk assessment instruments for juvenile sex offenders : What is next?

    NARCIS (Netherlands)

    Hempel, I.; Buck, N.M.L.; Cima-Knijff, M.J.; van Marle, H.

    2013-01-01

    Risk assessment is considered to be a key element in the prevention of recidivism among juvenile sex offenders (JSOs), often by imposing long-term consequences based on that assessment. The authors reviewed the literature on the predictive accuracy of six well-known risk assessment instruments used

  2. Systematic review regulatory principles of non-coding RNAs in cardiovascular diseases.

    Science.gov (United States)

    Li, Yongsheng; Huo, Caiqin; Pan, Tao; Li, Lili; Jin, Xiyun; Lin, Xiaoyu; Chen, Juan; Zhang, Jinwen; Guo, Zheng; Xu, Juan; Li, Xia

    2017-08-16

    Cardiovascular diseases (CVDs) continue to be a major cause of morbidity and mortality, and non-coding RNAs (ncRNAs) play critical roles in CVDs. With the recent emergence of high-throughput technologies, including small RNA sequencing, investigations of CVDs have been transformed from candidate-based studies into genome-wide undertakings, and a number of ncRNAs in CVDs were discovered in various studies. A comprehensive review of these ncRNAs would be highly valuable for researchers to get a complete picture of the ncRNAs in CVD. To address these knowledge gaps and clinical needs, in this review, we first discussed dysregulated ncRNAs and their critical roles in cardiovascular development and related diseases. Moreover, we reviewed >28 561 published papers and documented the ncRNA-CVD association benchmarking data sets to summarize the principles of ncRNA regulation in CVDs. This data set included 13 249 curated relationships between 9503 ncRNAs and 139 CVDs in 12 species. Based on this comprehensive resource, we summarized the regulatory principles of dysregulated ncRNAs in CVDs, including the complex associations between ncRNA and CVDs, tissue specificity and ncRNA synergistic regulation. The highlighted principles are that CVD microRNAs (miRNAs) are highly expressed in heart tissue and that they play central roles in miRNA-miRNA functional synergistic network. In addition, CVD-related miRNAs are close to one another in the functional network, indicating the modular characteristic features of CVD miRNAs. We believe that the regulatory principles summarized here will further contribute to our understanding of ncRNA function and dysregulation mechanisms in CVDs. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  3. Using the IRRS to Strengthen Regulatory Competence in Ireland

    International Nuclear Information System (INIS)

    Smith, K.

    2016-01-01

    In 2015, Ireland underwent an IRRS (Integrated Regulatory Review Service) review mission. The purpose of the mission was to review Ireland’s radiation and nuclear safety regulatory framework and activities against the relevant IAEA safety standards, to report on the regulatory effectiveness and to exchange information and experience in the areas covered by the IRRS. The review mission was well-timed as there had been recent changes in the regulatory infrastructure with the merger of the Radiological Protection Institute of Ireland (RPII) and the Environmental Protection Agency (EPA) in 2014, as well as the upcoming implementation of the new Euratom Basic Safety Standards (BSS) Directive. The key objectives of the mission were to enhance the national legal, governmental and regulatory framework for nuclear and radiation safety, and national arrangements for emergency preparedness and response. The agreed scope of the review covered all relevant facilities and activities regulated in Ireland and also included medical exposures and public exposure to radon. In advance of the mission, Ireland completed a process of self-assessment and review. This process identified strengths and weaknesses in the national regulatory framework compared with the international standards. In addition to the value of having Ireland’s radiation protection framework peer reviewed by senior international experts, the mission helped to further strengthen links between all the national bodies (government, licensees, regulatory) with a role in the regulation of radiation safety. The findings from the IRRS review team’s objective evaluation of Ireland’s regulatory infrastructure are being used to prioritise actions for strengthening the regulatory framework, to provide input into the transposition of the Euratom BSS, and to support the revision of the national emergency plan for nuclear accidents. It is planned to have addressed the findings of the IRRS mission in advance of a follow up

  4. NRC perspectives on the digital system review process

    International Nuclear Information System (INIS)

    Mauck, J.L.

    1998-01-01

    Since about 1988, the USNRC has been involved in the review of digital retrofits to instrumentation and control (I and C) systems in nuclear power plants. Initially, this involvement was limited but with the advent of the 1990s, NRC involvement has become greater because of increased interest in and application of digital systems as existing analog systems become obsolete. Criteria for the design of such systems to ensure safety has been promulgated over the years and the USNRC has been actively involved both nationally and internationally with this effort. With the publication of the Zion Eagle 21 Safety Evaluation Report in 1992, Generic Letter 95-02 in April 1995 which endorses EPRI guidance document TR-102348 on digital upgrades and the latest revision to Regulatory Guide 1.152 which endorses IEEE 7.4.3.2-1993; a basic digital system review process was established. The NRC supplemented this review process with recently issued inspection procedures for use by NRC inspectors when conducting onsite reviews of digital modifications. In addition, the NRC undertook a major effort to codify the above guidance and the experience gained from digital system reviews of both operating plant modifications and advanced reactor designs, over these years into a revision to Standard Review Plan, (SRP), NUREG-0800, Chapter 7, Instrumentation and Control. This SRP revision was published in June, 1997, and included new SRP sections, branch technical positions and six new regulatory guides endorsing IEEE standards on software quality. The NRC staff believes that a stable digital system review process is now in place. (author)

  5. Informal caregiving in COPD: A systematic review of instruments and their measurement properties.

    Science.gov (United States)

    Cruz, Joana; Marques, Alda; Machado, Ana; O'Hoski, Sachi; Goldstein, Roger; Brooks, Dina

    2017-07-01

    Increasing symptoms and activity restriction associated with COPD progression greatly impact on the lives of their informal caregivers, who play a vital role in maintaining their health. An understanding of this impact is important for clinicians to support caregivers and maintain a viable patient environment at home. This systematic review aimed to identify the instruments commonly used to assess informal caregiving in COPD and describe their measurement properties in this population. Searches were conducted in PubMed, Scopus, Web of Science, CINAHL and PsycINFO and in references of key articles, until November 2016 (PROSPERO: CRD42016041401). Instruments used to assess the impact of COPD on caregivers were identified and their properties described. Quality of studies was rated using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Quality of the measurement properties of instruments was rated as 'positive', 'negative' or 'indeterminate'. Patients cared for, had moderate to very severe COPD and the sample of caregivers ranged from 24 to 406. Thirty-five instruments were used in fifty studies to assess caregivers' psychological status and mood (9 instruments), burden/distress (12 instruments), quality of life (5 instruments) or other (9 instruments). Eighteen studies assessed the measurement properties of 21 instruments, most commonly hypothesis testing (known validity) and internal consistency. Study quality varied from 'poor' to 'fair' and with many properties rated as 'indeterminate'. Although several instruments have been used to assess the impact of COPD on caregivers, an increased understanding of their properties is needed before their widespread implementation. Copyright © 2017 Elsevier Ltd. All rights reserved.

  6. Outline of the requirements of application of computer based instrumentation and control systems in the systems important to safety on Bohunice NPPs

    International Nuclear Information System (INIS)

    Bacurik, J.

    1997-01-01

    The most important regulatory requirements and issues are described related to the review, evaluation and assessment of computer-based safety-related IandC systems, with emphasis on safety instrumentation and control. These aspects include safety classification and categorization of IandC, ranking of applicable codes and standards, design evaluation on the system level, and software assessment. (author)

  7. Regulatory issues on using programmable logic device in nuclear power plants

    International Nuclear Information System (INIS)

    Park, G. Y.; Yu, Y. J.; Kim, H. T.; Kwon, Y. I.; Park, H. S.; Jeong, C. H.

    2012-01-01

    For replacing obsolete analog equipment in nuclear power plant, the Programmable Logic Devices (PLDs) using Hardware Description Language (HDL) have been widely adopted in digitalized Instrumentation and Control (I and C) systems because of its flexibility. For safety reviews on Nuclear Power Plants (NPPs,) qualifying digitalized safety I and C system using PLDs is an important issue. As an effort to provide regulatory position on using PLDs in safety I and C system, there is a research project to provide the regulatory positions against emerging issues involved with digitalisation of I and C system including using PLDs. Therefore, this paper addresses the important considerations for using PLDs in safety I and C systems such as diversity, independence and qualification, etc. In this point, this study focuses on technical reports for Field Programmable Gate Array (FPGA) from EPRI,. U.S. NRC, and relevant technical standards

  8. Regulatory issues on using programmable logic device in nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Park, G. Y.; Yu, Y. J.; Kim, H. T.; Kwon, Y. I.; Park, H. S.; Jeong, C. H. [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2012-10-15

    For replacing obsolete analog equipment in nuclear power plant, the Programmable Logic Devices (PLDs) using Hardware Description Language (HDL) have been widely adopted in digitalized Instrumentation and Control (I and C) systems because of its flexibility. For safety reviews on Nuclear Power Plants (NPPs,) qualifying digitalized safety I and C system using PLDs is an important issue. As an effort to provide regulatory position on using PLDs in safety I and C system, there is a research project to provide the regulatory positions against emerging issues involved with digitalisation of I and C system including using PLDs. Therefore, this paper addresses the important considerations for using PLDs in safety I and C systems such as diversity, independence and qualification, etc. In this point, this study focuses on technical reports for Field Programmable Gate Array (FPGA) from EPRI,. U.S. NRC, and relevant technical standards.

  9. 75 FR 21299 - Determination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT-NDA 22-254

    Science.gov (United States)

    2010-04-23

    ... additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under...). VIMPAT injection is indicated as adjunctive therapy in the treatment of partial-onset seizures in...

  10. [Validated Instruments for the Psychological Assessment of Unaccompanied Refugee Minors - a Systematic Review].

    Science.gov (United States)

    Rassenhofer, Miriam; Fegert, Jörg Michael; Plener, Paul L; Witt, Andreas

    2016-01-01

    The German care system faces a growing number of unaccompanied refugee minors (URM). URM show high levels of traumatization, a variety of psychological symptoms and lack important resilience factors. Therefore an early and valid psychological assessment is important for intervention and service planning. Yet, no systematic review on validated instruments for the assessment of this group exists. Literature search revealed one study about translators in the assessment of URM and five validated instruments for proxy and self-report. These instruments are available in several languages and showed good psychometric properties. It has to be critically stated that all instruments have been validated by a single work group within a single population. Especially with regards to changing definitions of Posttraumatic Stress Disorder within the new (and upcoming) classification systems ICD-11 and DSM-5, increased awareness for diagnostic procedures is necessary. Additionally, more validated instruments for specific psychological disorders in multiple languages are needed. Under an economic perspective the use of open access questionnaires that are available in different languages seems useful, even if they are not especially validated for URM.

  11. 75 FR 21298 - Determination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT -NDA 22-253

    Science.gov (United States)

    2010-04-23

    ... additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under... (lacosamide). VIMPAT tablets are indicated as adjunctive therapy in the treatment of partial-onset seizures in...

  12. Recent Findings on Tax-Related Regulatory Burden on SMMEs in South Africa. Literature Review and Policy Options

    OpenAIRE

    Doubell Chamberlain; Anja Smith

    2006-01-01

    Regulatory compliance costs impose a deadweight burden on firms and therefore should be minimised. In achieving this goal, it is necessary to embrace a process of smart regulation, rather than focus on deregulation. Tax compliance cost is one type of regulatory costs that is often viewed to have a large negative impact on SMMEs. To gauge the impact of this cost on small business in South Africa, this document reviews three available studies on the impact of tax compliance costs on South Afric...

  13. A historical review of portable health physics instruments and their use in radiation protection programs at Hanford, 1944 through 1988

    Energy Technology Data Exchange (ETDEWEB)

    Howell, W.P.; Kenoyer, J.L.; Kress, M.L.; Swinth, K.L.; Corbit, C.D.; Zuerner, L.V.; Fleming, D.M.; DeHaven, H.W.

    1989-09-01

    This historical review covers portable health physics instruments at Hanford from an applications viewpoint. The review provides information on specific instruments and on the general kinds of facility work environments in which the instruments have been and are being used. It provides a short, modestly technical explanation of the types of nuclear radiations, the way radiation units are quantified, and the types of nuclear radiations, the way radiation units are quantified, and the types of detection media used in portable health physics instruments. This document does not, however, cover the history of the entire Hanford program that was required to develop and/or modify the subject instruments. 11 refs., 34 figs., 2 tabs.

  14. A historical review of portable health physics instruments and their use in radiation protection programs at Hanford, 1944 through 1988

    International Nuclear Information System (INIS)

    Howell, W.P.; Kenoyer, J.L.; Kress, M.L.; Swinth, K.L.; Corbit, C.D.; Zuerner, L.V.; Fleming, D.M.; DeHaven, H.W.

    1989-09-01

    This historical review covers portable health physics instruments at Hanford from an applications viewpoint. The review provides information on specific instruments and on the general kinds of facility work environments in which the instruments have been and are being used. It provides a short, modestly technical explanation of the types of nuclear radiations, the way radiation units are quantified, and the types of nuclear radiations, the way radiation units are quantified, and the types of detection media used in portable health physics instruments. This document does not, however, cover the history of the entire Hanford program that was required to develop and/or modify the subject instruments. 11 refs., 34 figs., 2 tabs

  15. 78 FR 55118 - Seismic Instrumentation for Nuclear Power Plants

    Science.gov (United States)

    2013-09-09

    ... NUCLEAR REGULATORY COMMISSION [NRC-2013-0202] Seismic Instrumentation for Nuclear Power Plants... Reports for Nuclear Power Plants: LWR Edition,'' Section 3.7.4, ``Seismic Instrumentation.'' DATES: Submit... Nuclear Power Plants: LWR Edition'' (SRP, from the current Revision 2 to a new Revision 3). The proposed...

  16. A review of NRC regulatory processes and functions

    International Nuclear Information System (INIS)

    1981-05-01

    A reexamination by the ACRS of the Regulatory Process has been made. Objectives were to provide in a single source, ACRS' understanding of the Regulatory Process and to point out perceived weaknesses and to make appropriate recommendations for change

  17. Jones' instrument technology

    CERN Document Server

    Jones, Ernest Beachcroft; Kingham, Edward G; Radnai, Rudolf

    1985-01-01

    Jones' Instrument Technology, Volume 5: Automatic Instruments and Measuring Systems deals with general trends in automatic instruments and measuring systems. Specific examples are provided to illustrate the principles of such devices. A brief review of a considerable number of standards is undertaken, with emphasis on the IEC625 Interface System. Other relevant standards are reviewed, including the interface and backplane bus standards. This volume is comprised of seven chapters and begins with a short introduction to the principles of automatic measurements, classification of measuring system

  18. Regulatory mechanisms for absenteeism in the health sector: a systematic review of strategies and their implementation

    Science.gov (United States)

    Kisakye, Angela N; Tweheyo, Raymond; Ssengooba, Freddie; Pariyo, George W; Rutebemberwa, Elizeus; Kiwanuka, Suzanne N

    2016-01-01

    Background A systematic review was undertaken to identify regulatory mechanisms aimed at mitigating health care worker absenteeism, to describe where and how they have been implemented as well as their possible effects. The goal was to propose potential policy options for managing the problem of absenteeism among human resources for health in low- and middle-income countries. Mechanisms described in this review are at the local workplace and broader national policy level. Methods A comprehensive online search was conducted on EMBASE, CINAHL, PubMed, Google Scholar, Google, and Social Science Citation Index using MEDLINE search terms. Retrieved studies were uploaded onto reference manager and screened by two independent reviewers. Only publications in English were included. Data were extracted and synthesized according to the objectives of the review. Results Twenty six of the 4,975 published articles retrieved were included. All were from high-income countries and covered all cadres of health workers. The regulatory mechanisms and possible effects include 1) organizational-level mechanisms being reported as effective in curbing absenteeism in low- and middle-income countries (LMICs); 2) prohibition of private sector activities in LMICs offering benefits but presenting a challenge for the government to monitor the health workforce; 3) contractual changes from temporary to fixed posts having been associated with no reduction in absenteeism and not being appropriate for LMICs; 4) multifaceted work interventions being implemented in most settings; 5) the possibility of using financial and incentive regulatory mechanisms in LMICs; 6) health intervention mechanisms reducing absenteeism when integrated with exercise programs; and 7) attendance by legislation during emergencies being criticized for violating human rights in the United States and not being effective in curbing absenteeism. Conclusion Most countries have applied multiple strategies to mitigate health care

  19. Regulatory mechanisms for absenteeism in the health sector: a systematic review of strategies and their implementation.

    Science.gov (United States)

    Kisakye, Angela N; Tweheyo, Raymond; Ssengooba, Freddie; Pariyo, George W; Rutebemberwa, Elizeus; Kiwanuka, Suzanne N

    2016-01-01

    A systematic review was undertaken to identify regulatory mechanisms aimed at mitigating health care worker absenteeism, to describe where and how they have been implemented as well as their possible effects. The goal was to propose potential policy options for managing the problem of absenteeism among human resources for health in low- and middle-income countries. Mechanisms described in this review are at the local workplace and broader national policy level. A comprehensive online search was conducted on EMBASE, CINAHL, PubMed, Google Scholar, Google, and Social Science Citation Index using MEDLINE search terms. Retrieved studies were uploaded onto reference manager and screened by two independent reviewers. Only publications in English were included. Data were extracted and synthesized according to the objectives of the review. Twenty six of the 4,975 published articles retrieved were included. All were from high-income countries and covered all cadres of health workers. The regulatory mechanisms and possible effects include 1) organizational-level mechanisms being reported as effective in curbing absenteeism in low- and middle-income countries (LMICs); 2) prohibition of private sector activities in LMICs offering benefits but presenting a challenge for the government to monitor the health workforce; 3) contractual changes from temporary to fixed posts having been associated with no reduction in absenteeism and not being appropriate for LMICs; 4) multifaceted work interventions being implemented in most settings; 5) the possibility of using financial and incentive regulatory mechanisms in LMICs; 6) health intervention mechanisms reducing absenteeism when integrated with exercise programs; and 7) attendance by legislation during emergencies being criticized for violating human rights in the United States and not being effective in curbing absenteeism. Most countries have applied multiple strategies to mitigate health care worker absenteeism. The success of these

  20. Attention to gender in communication skills assessment instruments in medical education: a review.

    NARCIS (Netherlands)

    Dielissen, P.W.; Bottema, B.J.A.M.; Verdonk, P.; Lagro-Janssen, T.

    2011-01-01

    CONTEXT: Gender is increasingly regarded as an important factor in doctor-patient communication education. This review aims to assess if and how gender is addressed by current assessment instruments for communication skills in medical education. METHODS: In 2009 at Radboud University Nijmegen

  1. Instruments to assess integrated care

    DEFF Research Database (Denmark)

    Lyngsø, Anne Marie; Godtfredsen, Nina Skavlan; Høst, Dorte

    2014-01-01

    INTRODUCTION: Although several measurement instruments have been developed to measure the level of integrated health care delivery, no standardised, validated instrument exists covering all aspects of integrated care. The purpose of this review is to identify the instruments concerning how to mea...... was prevalent. It is uncertain whether development of a single 'all-inclusive' model for assessing integrated care is desirable. We emphasise the continuing need for validated instruments embedded in theoretical contexts.......INTRODUCTION: Although several measurement instruments have been developed to measure the level of integrated health care delivery, no standardised, validated instrument exists covering all aspects of integrated care. The purpose of this review is to identify the instruments concerning how...... to measure the level of integration across health-care sectors and to assess and evaluate the organisational elements within the instruments identified. METHODS: An extensive, systematic literature review in PubMed, CINAHL, PsycINFO, Cochrane Library, Web of Science for the years 1980-2011. Selected...

  2. Instrument accuracy in reactor vessel inventory tracking systems

    International Nuclear Information System (INIS)

    Anderson, J.L.; Anderson, R.L.; Morelock, T.C.; Hauang, T.L.; Phillips, L.E.

    1986-01-01

    Instrumentation needs for detection of inadequate core cooling. Studies of the Three Mile Island accident identified the need for additional instrumentation to detect inadequate core cooling (ICC) in nuclear power plants. Industry studies by plant owners and reactor vendors supported the conclusion that improvements were needed to help operators diagnose the approach to or existence of ICC as well as to provide more complete information for operator control of safety injection flow to minimize the consequences of such an accident. In 1980, the US Nuclear Regulatory Commission (NRC) required further studies by the industry and described ICC instrumentation design requirements that included human factors and environmental considerations. On December 10, 1982, NRC issued to Babcock and Wilcox (B and W) licensees orders for Modification of License and transmitted to pressurized water reactor licensees Generic Letter 82-28 to inform them of the revised NRC requirements. The instrumentation requirements include upgraded subcooling margin monitors (SMM), upgraded core exit thermocouples (CET), and installation of a reactor coolant inventory tracking system. NRC Regulatory Guide 1.97, which covers accident monitoring instrumentation, was revised (Rev. 3) to be consistent with the requirements of item II.F.2 of NUREG-0737

  3. Review and assessment of nuclear facilities by the regulatory body. Safety guide

    International Nuclear Information System (INIS)

    2004-01-01

    The purpose of this Safety Guide is to provide recommendations for regulatory bodies on reviewing and assessing the various safety related submissions made by the operator of a nuclear facility at different stages (siting, design, construction, commissioning, operation and decommissioning or closure) in the facility's lifetime to determine whether the facility complies with the applicable safety objectives and requirements. This Safety Guide covers the review and assessment of submissions in relation to the safety of nuclear facilities such as: enrichment and fuel manufacturing plants. Nuclear power plants. Other reactors such as research reactors and critical assemblies. Spent fuel reprocessing plants. And facilities for radioactive waste management, such as treatment, storage and disposal facilities. This Safety Guide also covers issues relating to the decommissioning of nuclear facilities, the closure of waste disposal facilities and site rehabilitation. Objectives, management, planning and organizational matters relating to the review and assessment process are presented in Section 2. Section 3 deals with the bases for decision making and conduct of the review and assessment process. Section 4 covers aspects relating to the assessment of this process. The Appendix provides a generic list of topics to be covered in the review and assessment process

  4. Review and assessment of nuclear facilities by the regulatory body. Safety guide

    International Nuclear Information System (INIS)

    2005-01-01

    The purpose of this Safety Guide is to provide recommendations for regulatory bodies on reviewing and assessing the various safety related submissions made by the operator of a nuclear facility at different stages (siting, design, construction, commissioning, operation and decommissioning or closure) in the facility's lifetime to determine whether the facility complies with the applicable safety objectives and requirements. This Safety Guide covers the review and assessment of submissions in relation to the safety of nuclear facilities such as: enrichment and fuel manufacturing plants. Nuclear power plants. Other reactors such as research reactors and critical assemblies. Spent fuel reprocessing plants. And facilities for radioactive waste management, such as treatment, storage and disposal facilities. This Safety Guide also covers issues relating to the decommissioning of nuclear facilities, the closure of waste disposal facilities and site rehabilitation. Objectives, management, planning and organizational matters relating to the review and assessment process are presented in Section 2. Section 3 deals with the bases for decision making and conduct of the review and assessment process. Section 4 covers aspects relating to the assessment of this process. The Appendix provides a generic list of topics to be covered in the review and assessment process

  5. Calibration and assessment of electrochemical air quality sensors by co-location with regulatory-grade instruments

    Science.gov (United States)

    Hagan, David H.; Isaacman-VanWertz, Gabriel; Franklin, Jonathan P.; Wallace, Lisa M. M.; Kocar, Benjamin D.; Heald, Colette L.; Kroll, Jesse H.

    2018-01-01

    The use of low-cost air quality sensors for air pollution research has outpaced our understanding of their capabilities and limitations under real-world conditions, and there is thus a critical need for understanding and optimizing the performance of such sensors in the field. Here we describe the deployment, calibration, and evaluation of electrochemical sensors on the island of Hawai`i, which is an ideal test bed for characterizing such sensors due to its large and variable sulfur dioxide (SO2) levels and lack of other co-pollutants. Nine custom-built SO2 sensors were co-located with two Hawaii Department of Health Air Quality stations over the course of 5 months, enabling comparison of sensor output with regulatory-grade instruments under a range of realistic environmental conditions. Calibration using a nonparametric algorithm (k nearest neighbors) was found to have excellent performance (RMSE 0.997) across a wide dynamic range in SO2 ( 2 ppm). However, since nonparametric algorithms generally cannot extrapolate to conditions beyond those outside the training set, we introduce a new hybrid linear-nonparametric algorithm, enabling accurate measurements even when pollutant levels are higher than encountered during calibration. We find no significant change in instrument sensitivity toward SO2 after 18 weeks and demonstrate that calibration accuracy remains high when a sensor is calibrated at one location and then moved to another. The performance of electrochemical SO2 sensors is also strong at lower SO2 mixing ratios (pollutant species in other areas (e.g., polluted urban regions), the calibration and validation approaches described here should be widely applicable to a range of pollutants, sensors, and environments.

  6. A review of psychological assessment instruments for use in bariatric surgery evaluations.

    Science.gov (United States)

    Marek, Ryan J; Heinberg, Leslie J; Lavery, Megan; Merrell Rish, Julie; Ashton, Kathleen

    2016-09-01

    Bariatric surgery is a viable treatment option for patients with extreme obesity and associated medical comorbidities; however, optimal surgical outcomes are not universal. Surgical societies, such as the American Society for Metabolic and Bariatric Surgery (ASMBS), recommend that patients undergo a presurgical psychological evaluation that includes reviewing patients' medical charts, conducting a comprehensive clinical interview, and employing some form of objective psychometric testing. Despite numerous societies recommending the inclusion of self-report assessments, only about 2/3 of clinics actively use psychological testing-some of which have limited empirical support to justify their use. This review aims to critically evaluate the psychometric properties of self-report measures when used in bariatric surgery settings and provide recommendations to help guide clinicians in selecting instruments to use in bariatric surgery evaluations. Recommended assessment batteries include use of a broadband instrument along with a narrowband eating measure. Suggestions for self-report measures to include in a presurgical psychological evaluation in bariatric surgery settings are also provided. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  7. An Integrative Review of Self-Efficacy Measurement Instruments in Youth with Type 1 Diabetes (T1DM)

    Science.gov (United States)

    Rasbach, Lisa; Jenkins, Carolyn; Laffel, Lori

    2014-01-01

    Purpose The purpose of this study is to assess the extant literature on instruments used to measure self-efficacy in youth with type 1 diabetes (T1DM) and their caregivers and to critically evaluate these measurements. Methods An integrative review (2003–2013) was conducted searching PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and U.S. National Library of Medicine PubMed service (PubMed) databases using key words diabetes, type 1 diabetes, and self-efficacy. The authors reviewed the resulting294 references for inclusion criteria of (a) sample of youth with T1DM or sample of caregivers of youth with T1DM, (b) description of the self-efficacy instrument as primary research, and (c) the instrument measured self-efficacy specifically related to diabetes management. Forty-five articles out of the initial 294 met criteria. Results Of the 45 articles, 10 different self-efficacy instruments were identified. The primary theoretical framework used was Bandura’s social cognitive theory and model of self-efficacy. Most participants were white middle class T1DM youth. Evaluations to assess validity often were not reported; however, a majority of studies reported high internal consistency of the instruments. Conclusions Sample homogeneity could limit the applicability of results to certain patient populations. Further psychometric analysis, including validity assessments, should be conducted in more diverse samples. Development of valid and reliable instruments for measuring self-efficacy that are sensitive to change across a wider caregiver base over time is necessary. While this review examined reliable and valid instruments used in research, future opportunities include evaluation of measuring self-efficacy in T1DM youth exposed to recent advances in diabetes management technologies. PMID:25216655

  8. A review of instruments to measure interprofessional collaboration for chronic disease management for community-living older adults.

    Science.gov (United States)

    Bookey-Bassett, Sue; Markle-Reid, Maureen; McKey, Colleen; Akhtar-Danesh, Noori

    2016-01-01

    It is acknowledged internationally that chronic disease management (CDM) for community-living older adults (CLOA) is an increasingly complex process. CDM for older adults, who are often living with multiple chronic conditions, requires coordination of various health and social services. Coordination is enabled through interprofessional collaboration (IPC) among individual providers, community organizations, and health sectors. Measuring IPC is complicated given there are multiple conceptualisations and measures of IPC. A literature review of several healthcare, psychological, and social science electronic databases was conducted to locate instruments that measure IPC at the team level and have published evidence of their reliability and validity. Five instruments met the criteria and were critically reviewed to determine their strengths and limitations as they relate to CDM for CLOA. A comparison of the characteristics, psychometric properties, and overall concordance of each instrument with salient attributes of IPC found the Collaborative Practice Assessment Tool to be the most appropriate instrument for measuring IPC for CDM in CLOA.

  9. Understanding banking regulatory and market framework in South Africa including the perceived strength, weaknesses, opportunities and threats

    Directory of Open Access Journals (Sweden)

    Tankiso Moloi

    2014-08-01

    Full Text Available Following the global financial crisis of 2007, the manner in which banks conduct their business became the subject of interest to authorities. In South Africa, most analysts argued that the financial system was insulated by the prudent regulatory system. This paper reviewed the banking regulation and market framework applicable in the South African context. In reviewing regulation and banking market framework, it was found that the principal legal instrument which seeks to achieve credibility, stability and economic growth, is the Banks Act, No. 94 of 1990 (the Banks Act. Considering the applicable regulation, the paper concluded that South Africa has a developed and well regulated banking system which compares favourably with regulatory environment applied by the developed countries. It was, however; cautioned that further regulation such as the recently announced ‘Twin Peaks’ approach to financial regulation could result in unintended consequences, such as driving a larger share of activity into the shadow banking sector.

  10. Systematic review of qualitative literature on occupational health and safety legislation and regulatory enforcement planning and implementation.

    Science.gov (United States)

    MacEachen, Ellen; Kosny, Agnieszka; Ståhl, Christian; O'Hagan, Fergal; Redgrift, Lisa; Sanford, Sarah; Carrasco, Christine; Tompa, Emile; Mahood, Quenby

    2016-01-01

    The ability of occupational health and safety (OHS) legislation and regulatory enforcement to prevent workplace injuries and illnesses is contingent on political, economic, and organizational conditions. This systematic review of qualitative research articles considers how OHS legislation and regulatory enforcement are planned and implemented. A comprehensive search of peer-reviewed, English-language articles published between 1990 and 2013 yielded 11 947 articles. We identified 34 qualitative articles as relevant, 18 of which passed our quality assessment and proceeded to meta-ethnographic synthesis. The synthesis yielded four main themes: OHS regulation formation, regulation challenges, inspector organization, and worker representation in OHS. It illuminates how OHS legislation can be based on normative suppositions about worker and employer behavior and shaped by economic and political resources of parties. It also shows how implementation of OHS legislation is affected by "general duty" law, agency coordination, resourcing of inspectorates, and ability of workers to participate in the system. The review identifies methodological gaps and identifies promising areas for further research in "grey" zones of legislation implementation.

  11. Regulatory review and barriers for the electricity supply system for distributed generation in EU-15

    DEFF Research Database (Denmark)

    Ropenus, Stephanie; Skytte, Klaus

    2005-01-01

    When distributed electricity supply surpasses a particular level, it can no longer be ignored in planning and operation of the electricity networks. Therefore, improvements of the regulatory framework of the electricity networks are required along with the growth of the electricity supply from di...... distributed generation. This paper reviews the current regulation of the grids with respect to distributed generation in EU-15 Member States and compares the different systems. Several barriers are identified.......When distributed electricity supply surpasses a particular level, it can no longer be ignored in planning and operation of the electricity networks. Therefore, improvements of the regulatory framework of the electricity networks are required along with the growth of the electricity supply from...

  12. The IAEA Integrated Regulatory Review Service Mission to Sweden in February 2012

    International Nuclear Information System (INIS)

    2012-01-01

    The Swedish Government decided on January 22, 2009 to mandate the Swedish Radiation Safety Authority, SSM, to apply for an international review of the Authority and its areas of supervision, an 'IRRS' (Integrated Regulatory Review Service) carried out by the International Atomic Energy Agency (IAEA). On February 25, 2009, SSM made a formal request to the IAEA for an IRRS in Sweden. The time period for the IRRS mission was later agreed to be 6-17 February, 2012. This report summarises the project's progress immediately prior to the IRRS mission in February 2012. The report contains the findings from the self assessment performed by SSM staff. It also contains a plan to implement measures to remedy deficiencies that have been identified and to improve the radiation safety work of the Authority

  13. Tendances Carbone no. 69 'The EU ETS within the financial instrument regulatory framework: what are the implications?'

    International Nuclear Information System (INIS)

    Patay, Magali

    2012-01-01

    Among the publications of CDC Climat Research, 'Tendances Carbone' bulletin specifically studies the developments of the European market for CO 2 allowances. This issue addresses the following points: The European Commission added carbon allowances and international credits eligible for the EU ETS to Section C, Annex I of Directive 2004/39/EC, as part of its proposal to review the Markets in Financial Instruments Directive (MiFID) on October 20 2011

  14. A comprehensive review of sensors and instrumentation methods in devices for musical expression.

    Science.gov (United States)

    Medeiros, Carolina Brum; Wanderley, Marcelo M

    2014-07-25

    Digital Musical Instruments (DMIs) are musical instruments typically composed of a control surface where user interaction is measured by sensors whose values are mapped to sound synthesis algorithms. These instruments have gained interest among skilled musicians and performers in the last decades leading to artistic practices including musical performance, interactive installations and dance. The creation of DMIs typically involves several areas, among them: arts, design and engineering. The balance between these areas is an essential task in DMI design so that the resulting instruments are aesthetically appealing, robust, and allow responsive, accurate and repeatable sensing. In this paper, we review the use of sensors in the DMI community as manifested in the proceedings of the International Conference on New Interfaces for Musical Expression (NIME 2009-2013). Focusing on the sensor technologies and signal conditioning techniques used by the NIME community. Although it has been claimed that specifications for artistic tools are harder than those for military applications, this study raises a paradox showing that in most of the cases, DMIs are based on a few basic sensors types and unsophisticated engineering solutions, not taking advantage of more advanced sensing, instrumentation and signal processing techniques that could dramatically improve their response. We aim to raise awareness of limitations of any engineering solution and to assert the benefits of advanced electronics instrumentation design in DMIs. For this, we propose the use of specialized sensors such as strain gages, advanced conditioning circuits and signal processing tools such as sensor fusion. We believe that careful electronic instrumentation design may lead to more responsive instruments.

  15. A selective review of the first 20 years of instrumental variables models in health-services research and medicine.

    Science.gov (United States)

    Cawley, John

    2015-01-01

    The method of instrumental variables (IV) is useful for estimating causal effects. Intuitively, it exploits exogenous variation in the treatment, sometimes called natural experiments or instruments. This study reviews the literature in health-services research and medical research that applies the method of instrumental variables, documents trends in its use, and offers examples of various types of instruments. A literature search of the PubMed and EconLit research databases for English-language journal articles published after 1990 yielded a total of 522 original research articles. Citations counts for each article were derived from the Web of Science. A selective review was conducted, with articles prioritized based on number of citations, validity and power of the instrument, and type of instrument. The average annual number of papers in health services research and medical research that apply the method of instrumental variables rose from 1.2 in 1991-1995 to 41.8 in 2006-2010. Commonly-used instruments (natural experiments) in health and medicine are relative distance to a medical care provider offering the treatment and the medical care provider's historic tendency to administer the treatment. Less common but still noteworthy instruments include randomization of treatment for reasons other than research, randomized encouragement to undertake the treatment, day of week of admission as an instrument for waiting time for surgery, and genes as an instrument for whether the respondent has a heritable condition. The use of the method of IV has increased dramatically in the past 20 years, and a wide range of instruments have been used. Applications of the method of IV have in several cases upended conventional wisdom that was based on correlations and led to important insights about health and healthcare. Future research should pursue new applications of existing instruments and search for new instruments that are powerful and valid.

  16. Quality appraisal of generic self-reported instruments measuring health-related productivity changes: a systematic review

    Science.gov (United States)

    2014-01-01

    Background Health impairments can result in disability and changed work productivity imposing considerable costs for the employee, employer and society as a whole. A large number of instruments exist to measure health-related productivity changes; however their methodological quality remains unclear. This systematic review critically appraised the measurement properties in generic self-reported instruments that measure health-related productivity changes to recommend appropriate instruments for use in occupational and economic health practice. Methods PubMed, PsycINFO, Econlit and Embase were systematically searched for studies whereof: (i) instruments measured health-related productivity changes; (ii) the aim was to evaluate instrument measurement properties; (iii) instruments were generic; (iv) ratings were self-reported; (v) full-texts were available. Next, methodological quality appraisal was based on COSMIN elements: (i) internal consistency; (ii) reliability; (iii) measurement error; (iv) content validity; (v) structural validity; (vi) hypotheses testing; (vii) cross-cultural validity; (viii) criterion validity; and (ix) responsiveness. Recommendations are based on evidence syntheses. Results This review included 25 articles assessing the reliability, validity and responsiveness of 15 different generic self-reported instruments measuring health-related productivity changes. Most studies evaluated criterion validity, none evaluated cross-cultural validity and information on measurement error is lacking. The Work Limitation Questionnaire (WLQ) was most frequently evaluated with moderate respectively strong positive evidence for content and structural validity and negative evidence for reliability, hypothesis testing and responsiveness. Less frequently evaluated, the Stanford Presenteeism Scale (SPS) showed strong positive evidence for internal consistency and structural validity, and moderate positive evidence for hypotheses testing and criterion validity. The

  17. Instruments used in the assessment of expectation toward a spine surgery: an integrative review

    Directory of Open Access Journals (Sweden)

    Eliane Nepomuceno

    Full Text Available Abstract OBJECTIVE To identify and describe the instruments used to assess patients' expectations toward spine surgery. METHOD An integrative review was carried out in the databases PubMed, CINAHL, LILACS and PsycINFO. RESULTS A total of 4,402 publications were identified, of which 25 met the selection criteria. Of the studies selected, only three used tools that had confirmed validity and reliability to be applied; in five studies, clinical scores were used, and were modified for the assessment of patients' expectations, and in 17 studies the researchers developed scales without an adequate description of the method used for their development and validation. CONCLUSION The assessment of patients' expectations has been methodologically conducted in different ways. Until the completion of this integrative review, only two valid and reliable instruments had been used in three of the selected studies.

  18. Review of voluntary and regulatory carbon reporting by companies around the world

    International Nuclear Information System (INIS)

    Borie, Sylvain; Decq, Juliette; Wang, Xin; Alberola, Emilie; Afriat, Marion; Gourdon, Thomas

    2016-01-01

    What countries have instituted regulations requiring companies to measure their greenhouse gas (GHG) emissions? How could these regulations be strengthened to help meet the '2 deg. C' goal adopted by all member countries at the COP21 summit? In what ways do new French regulations on reporting of significant GHG emissions constitute a major advance in carbon reporting? To complement recent news focusing on reporting of carbon emissions in France, Carbone 4 offers its readers this review to put voluntary and regulatory carbon reporting mechanisms used by companies in a global perspective

  19. Assessment by peer review of the effectiveness of a regulatory programme for radiation safety. Interim report for comment

    International Nuclear Information System (INIS)

    2002-06-01

    This document covers assessment of those aspects of a radiation protection and safety infrastructure that are implemented by the Regulatory Authority for radiation sources and practices using such sources and necessarily includes those ancillary technical services, such as dosimetry services, which directly affect the ability of the Regulatory Authority to discharge its responsibilities. The focus of the guidance in this TECDOC is on assessment of a regulatory programme intended to implement the BSS. The BSS address transportation and waste safety mainly by reference to other IAEA documents. When conducting an assessment, the Review Team members should be aware of the latest IAEA documents (or similar national documents) concerning transportation and waste safety and, if appropriate, nuclear safety, and take them into account to the extent applicable when assessing the effectiveness of the regulatory programme governing radiation protection and safety of radiation source practices in a particular State

  20. Assessment by peer review of the effectiveness of a regulatory programme for radiation safety. Interim report for comment

    International Nuclear Information System (INIS)

    2001-05-01

    This document covers assessment of those aspects of a radiation protection and safety infrastructure that are implemented by the Regulatory Authority for radiation sources and practices using such sources and necessarily includes those ancillary technical services, such as dosimetry services, which directly affect the ability of the Regulatory Authority to discharge its responsibilities. The focus of the guidance in this TECDOC is on assessment of a regulatory programme intended to implement the BSS. The BSS address transportation and waste safety mainly by reference to other IAEA documents. When conducting an assessment, the Review Team members should be aware of the latest IAEA documents (or similar national documents) concerning transportation and waste safety and, if appropriate, nuclear safety, and take them into account to the extent applicable when assessing the effectiveness of the regulatory programme governing radiation protection and safety of radiation source practices in a particular State

  1. Attention to gender in communication skills assessment instruments in medical education: a review.

    Science.gov (United States)

    Dielissen, Patrick; Bottema, Ben; Verdonk, Petra; Lagro-Janssen, Toine

    2011-03-01

    Gender is increasingly regarded as an important factor in doctor-patient communication education. This review aims to assess if and how gender is addressed by current assessment instruments for communication skills in medical education. In 2009 at Radboud University Nijmegen Medical Centre, an online search was conducted in the bibliographic databases PubMed, PsycINFO and ERIC for references about communication skills assessment instruments designed to be completed by trained faculty staff and used in medical education. The search strategy used the following search terms: 'consultation skills'; 'doctor-patient communication'; 'physician-patient relations'; 'medical education'; 'instruments'; 'measurement', and 'assessment'. Papers published between January 1999 and June 2009 were included. The assessment instruments identified were analysed for gender-specific content. The search yielded 21 communication skills assessment instruments. Only two of the 17 checklists obtained explicitly considered gender as a communication-related issue. Only six of 21 manuals considered gender in any way and none gave specific details to explain which aspects of communication behaviour should be assessed with regard to gender. Very few communication assessment instruments in medical education focus on gender. Nevertheless, interest exists in using gender in communication skills assessment. The criteria for and purpose of assessing gender in communication skills in medical education are yet to be clarified. © Blackwell Publishing Ltd 2011.

  2. Measuring spirituality and religiosity in clinical research: a systematic review of instruments available in the Portuguese language.

    Science.gov (United States)

    Lucchetti, Giancarlo; Lucchetti, Alessandra Lamas Granero; Vallada, Homero

    2013-01-01

    Despite numerous spirituality and/or religiosity (S/R) measurement tools for use in research worldwide, there is little information on S/R instruments in the Portuguese language. The aim of the present study was to map out the S/R scales available for research in the Portuguese language. Systematic review of studies found in databases. A systematic review was conducted in three phases. Phases 1 and 2: articles in Portuguese, Spanish and English, published up to November 2011, dealing with the Portuguese translation and/or validation of S/R measurement tools for clinical research, were selected from six databases. Phase 3: the instruments were grouped according to authorship, cross-cultural adaptation, internal consistency, concurrent and discriminative validity and test-retest procedures. Twenty instruments were found. Forty-five percent of these evaluated religiosity, 40% spirituality, 10% religious/spiritual coping and 5% S/R. Among these, 90% had been produced in (n = 3) or translated to (n = 15) Brazilian Portuguese and two (10%) solely to European Portuguese. Nevertheless, the majority of the instruments had not undergone in-depth psychometric analysis. Only 40% of the instruments presented concurrent validity, 45% discriminative validity and 15% a test-retest procedure. The characteristics of each instrument were analyzed separately, yielding advantages, disadvantages and psychometric properties. Currently, 20 instruments for measuring S/R are available in the Portuguese language. Most have been translated (n = 15) or developed (n = 3) in Brazil and present good internal consistency. Nevertheless, few instruments have been assessed regarding all their psychometric qualities.

  3. An integrative review of literature examining psychometric properties of instruments measuring anxiety or fear in hospitalized children.

    Science.gov (United States)

    Foster, Roxie L; Park, Jeong-hwan

    2012-06-01

    Anxiety and fear are among the most frequently reported emotional responses to hospitalization and are known to be contributing factors to pain and other negative patient outcomes. The first step in confronting unnecessary anxiety and fear is to identify valid and clinically feasible assessment instruments. The purpose of this paper is to review and evaluate instruments that measure children's fear or anxiety associated with hospitalization or painful procedures. A search was conducted of published English-language literature from 1980 through 2010 with the use of Ovid Health and Psychosocial Instruments, Medline, Nursing/Academic Edition, Cinahl, and Google Scholar. Inclusion criteria specified that the self-report instrument: 1) was developed in English; 2) was developed for and/or widely used with hospitalized children or children undergoing medical procedures or treatment; and 3) had research evidence of psychometric properties from at least five different studies. A comprehensive review of the literature revealed only five fear or anxiety instruments with adequate testing for evaluation of reliability and validity. Although all instruments have beginning psychometric adequacy, no one tool stands out as superior to the others. Therefore, we recommend that researchers and clinicians exercise caution in choosing assessment instruments, balancing potential strengths with reported limitations. Using more than one tool (triangulating) may be one way to achieve more credible results. Knowledge of credible existing instruments alerts us to what is possible today and to the imperative for research that will improve communication with children tomorrow. Copyright © 2012 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

  4. Measuring spirituality and religiosity in clinical research: a systematic review of instruments available in the Portuguese language

    Directory of Open Access Journals (Sweden)

    Giancarlo Lucchetti

    Full Text Available CONTEXT AND OBJECTIVES Despite numerous spirituality and/or religiosity (S/R measurement tools for use in research worldwide, there is little information on S/R instruments in the Portuguese language. The aim of the present study was to map out the S/R scales available for research in the Portuguese language. DESIGN AND SETTING Systematic review of studies found in databases. METHODS A systematic review was conducted in three phases. Phases 1 and 2: articles in Portuguese, Spanish and English, published up to November 2011, dealing with the Portuguese translation and/or validation of S/R measurement tools for clinical research, were selected from six databases. Phase 3: the instruments were grouped according to authorship, cross-cultural adaptation, internal consistency, concurrent and discriminative validity and test-retest procedures. RESULTS Twenty instruments were found. Forty-five percent of these evaluated religiosity, 40% spirituality, 10% religious/spiritual coping and 5% S/R. Among these, 90% had been produced in (n = 3 or translated to (n = 15 Brazilian Portuguese and two (10% solely to European Portuguese. Nevertheless, the majority of the instruments had not undergone in-depth psychometric analysis. Only 40% of the instruments presented concurrent validity, 45% discriminative validity and 15% a test-retest procedure. The characteristics of each instrument were analyzed separately, yielding advantages, disadvantages and psychometric properties. CONCLUSION Currently, 20 instruments for measuring S/R are available in the Portuguese language. Most have been translated (n = 15 or developed (n = 3 in Brazil and present good internal consistency. Nevertheless, few instruments have been assessed regarding all their psychometric qualities.

  5. A systematic review of instruments that assess the implementation of hospital quality management systems.

    NARCIS (Netherlands)

    Groene, O.; Botje, D.; Suñol, R.; Lopez, M.A.; Wagner, C.

    2013-01-01

    Purpose: Health-care providers invest substantial resources to establish and implement hospital quality management systems. Nevertheless, few tools are available to assess implementation efforts and their effect on quality and safety outcomes. This review aims to (i) identify instruments to assess

  6. Risk-based Regulatory Evaluation Program methodology

    International Nuclear Information System (INIS)

    DuCharme, A.R.; Sanders, G.A.; Carlson, D.D.; Asselin, S.V.

    1987-01-01

    The objectives of this DOE-supported Regulatory Evaluation Progrwam are to analyze and evaluate the safety importance and economic significance of existing regulatory guidance in order to assist in the improvement of the regulatory process for current generation and future design reactors. A risk-based cost-benefit methodology was developed to evaluate the safety benefit and cost of specific regulations or Standard Review Plan sections. Risk-based methods can be used in lieu of or in combination with deterministic methods in developing regulatory requirements and reaching regulatory decisions

  7. Measurement properties of instruments evaluating self-care and related concepts in people with chronic obstructive pulmonary disease: A systematic review.

    Science.gov (United States)

    Clari, Marco; Matarese, Maria; Alvaro, Rosaria; Piredda, Michela; De Marinis, Maria Grazia

    2016-01-01

    The use of valid and reliable instruments for assessing self-care is crucial for the evaluation of chronic obstructive pulmonary disease (COPD) management programs. The aim of this review is to evaluate the measurement properties and theoretical foundations of instruments for assessing self-care and related concepts in people with COPD. A systematic review was conducted of articles describing the development and validation of self-care instruments. The methodological quality of the measurement properties was assessed using the COSMIN checklist. Ten studies were included evaluating five instruments: three for assessing self-care and self-management and two for assessing self-efficacy. The COPD Self-Efficacy Scale was the most studied instrument, but due to poor study methodological quality, evidence about its measurement properties is inconclusive. Evidence from the COPD Self-Management Scale is more promising, but only one study tested its properties. Due to inconclusive evidence of their measurement properties, no instrument can be recommended for clinical use. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. Human factors survey of advanced instrumentation and controls technologies in nuclear plants

    International Nuclear Information System (INIS)

    Carter, R.J.

    1992-01-01

    A survey of advanced instrumentation and controls (I ampersand C) technologies and associated human factors issues in the US and Canadian nuclear industries was carried out by a team from Oak Ridge national laboratory to provide background for the development of regulatory policy, criteria, and guides for review of advanced I ampersand C systems as well as human engineering guidelines for evaluating these systems. The survey found those components of the US nuclear industry surveyed to be quite interested in advanced I ampersand C, but very cautious in implementing such systems in nuclear facilities and power plants. The trend in the facilities surveyed is to experiment cautiously when there is an intuitive advantage or short-term payoff. In the control room, the usual practice is direct substitution of digital and microprocessor-based instruments or systems that are functionally identical to the analog instruments or systems being replaced. The most advanced I ampersand C systems were found in the Canadian CANDU plants, where the newest plant has digital system in almost 100% of its control systems and in over 70% of its plant protection system. The hypothesis that properly 'introducing digital systems increases safety' is supported by the Canadian experience. The performance of these digital systems was achieved using an appropriate quality assurance program for the software development. The ability of digital systems to detect impending failures and initiate a fail-safe action, is a significant safety issue that should be of special interest to every US utility as well as to the US Nuclear Regulatory Commission. (orig.)

  9. A Technological Review of the Instrumented Footwear for Rehabilitation with a Focus on Parkinson’s Disease Patients

    DEFF Research Database (Denmark)

    Maculewicz, Justyna; Kofoed, Lise; Serafin, Stefania

    2016-01-01

    In this review article, we summarize systems for gait rehabilitation based on instrumented footwear and present a context of their usage in Parkinson’s disease (PD) patients’ auditory and haptic rehabilitation. We focus on the needs of PD patients, but since only a few systems were made with this......In this review article, we summarize systems for gait rehabilitation based on instrumented footwear and present a context of their usage in Parkinson’s disease (PD) patients’ auditory and haptic rehabilitation. We focus on the needs of PD patients, but since only a few systems were made...

  10. A Comprehensive Review of Sensors and Instrumentation Methods in Devices for Musical Expression

    Directory of Open Access Journals (Sweden)

    Carolina Brum Medeiros

    2014-07-01

    Full Text Available Digital Musical Instruments (DMIs are musical instruments typically composed of a control surface where user interaction is measured by sensors whose values are mapped to sound synthesis algorithms. These instruments have gained interest among skilled musicians and performers in the last decades leading to artistic practices including musical performance, interactive installations and dance. The creation of DMIs typically involves several areas, among them: arts, design and engineering. The balance between these areas is an essential task in DMI design so that the resulting instruments are aesthetically appealing, robust, and allow responsive, accurate and repeatable sensing. In this paper, we review the use of sensors in the DMI community as manifested in the proceedings of the International Conference on New Interfaces for Musical Expression (NIME 2009–2013. Focusing on the sensor technologies and signal conditioning techniques used by the NIME community. Although it has been claimed that specifications for artistic tools are harder than those for military applications, this study raises a paradox showing that in most of the cases, DMIs are based on a few basic sensors types and unsophisticated engineering solutions, not taking advantage of more advanced sensing, instrumentation and signal processing techniques that could dramatically improve their response. We aim to raise awareness of limitations of any engineering solution and to assert the benefits of advanced electronics instrumentation design in DMIs. For this, we propose the use of specialized sensors such as strain gages, advanced conditioning circuits and signal processing tools such as sensor fusion. We believe that careful electronic instrumentation design may lead to more responsive instruments.

  11. Preparing and Conducting Review Missions of Instrumentation and Control Systems in Nuclear Power Plants

    International Nuclear Information System (INIS)

    2016-07-01

    The IERICS (Independent Engineering Review of Instrumentation and Control Systems) mission is a comprehensive engineering review service directly addressing strategy and the key elements for implementation of modern instrumentation and control (I&C) systems, noting in applicable cases, specific concerns related to the implementation of advanced digital I&C systems and the use of software and/or digital logic in safety applications of a nuclear power plant. The guidelines outlined in this publication provide a basic structure, common reference and checklist across the various areas covered by an IERICS mission. Publications referenced in these guidelines could provide additional useful information for the counterpart while preparing for the IERICS mission. A structure for the mission report is given in the Appendix. In 2016, this publication was revised by international experts who had participated in previous IERICS missions. The revision reflects experiences and lessons learned from the preparation and conduct of those missions

  12. Self-administered health literacy instruments for people with diabetes: systematic review of measurement properties.

    Science.gov (United States)

    Lee, Eun-Hyun; Kim, Chun-Ja; Lee, Jiyeon; Moon, Seung Hei

    2017-09-01

    The aims of this study were to identify all available self-administered instruments measuring health literacy in people with diabetes and to determine the current instrument that is the most appropriate for applying to this population in both practice and research. A systematic review of measurement properties. MEDLINE, EMBASE and CINAHL electronic databases from their inception up to 28 March 2016. The methodological quality of each included study was assessed using the COnsensus-based Standards for the selection of health Measurement INstruments checklist. The reported results for measurement properties in the studies were assessed according to Terwee's quality criteria. Thirteen self-administered instruments measuring health literacy in people with diabetes were identified, of which six (44%) were diabetes-specific instruments. The instruments that covered the broadest contents of health literacy were the Health Literacy Scale and Health Literacy Questionnaire. The (test-retest) reliability, measurement error and responsiveness were not evaluated for any instrument, while internal consistency and hypothesis testing validity were the most frequently assessed measurement properties. With the current evidence, the Health Literacy Scale may be the most appropriate instrument for patients with diabetes in practice and research. However, the structural validity of this scale needs to be further established, particularly in other language versions. It is also recommended to use the Diabetes Numeracy Test-15 along with the Health Literacy Scale to complement the lack of numeracy measures in the Health Literacy Scale. © 2017 John Wiley & Sons Ltd.

  13. A systematic review of instruments that assess the implementation of hospital quality management systems.

    Science.gov (United States)

    Groene, Oliver; Botje, Daan; Suñol, Rosa; Lopez, Maria Andrée; Wagner, Cordula

    2013-10-01

    Health-care providers invest substantial resources to establish and implement hospital quality management systems. Nevertheless, few tools are available to assess implementation efforts and their effect on quality and safety outcomes. This review aims to (i) identify instruments to assess the implementation of hospital quality management systems, (ii) describe their measurement properties and (iii) assess the effects of quality management on quality improvement and quality of care outcomes. We performed a systematic literature search from 1990 to 2011 in PubMed, CINAHL, EMBASE, Cochrane Library and Web of Science. In addition, we used snowball strategies, screened the reference lists of eligible papers, reviewed grey literature and contacted experts in the field. and data extraction Two reviewers screened eligible papers based on pre-defined inclusion and exclusion criteria and all authors extracted data. Eligible papers are described in terms of general characteristics (settings, type and level of respondents, mode of data collection), methodological properties (sampling strategy, item derivation, conceptualization of quality management, assessment of reliability and validity, scoring) and application/implementation (accounting for context, organizational adaptations, sensitivity to change, deployment and effect size). Eighteen papers were deemed eligible for inclusion. While some common domains emerged in measurement conceptualization, substantial differences in scope persist. The instruments' measurement properties were insufficiently described and only few instruments assessed links between the implementation of quality management systems (QMS) and improvement strategies or outcomes. There is currently no well-established measure to assess the implementation and effectiveness of quality management systems. Future research should address this gap.

  14. Measurement properties of adult quality-of-life measurement instruments for eczema: a systematic review.

    Science.gov (United States)

    Heinl, D; Prinsen, C A C; Deckert, S; Chalmers, J R; Drucker, A M; Ofenloch, R; Humphreys, R; Sach, T; Chamlin, S L; Schmitt, J; Apfelbacher, C

    2016-03-01

    The Harmonising Outcome Measures for Eczema (HOME) initiative has identified quality of life (QoL) as a core outcome domain to be evaluated in every eczema trial. It is unclear which of the existing QoL instruments is most appropriate for this domain. Thus, the aim of this review was to systematically assess the measurement properties of existing measurement instruments developed and/or validated for the measurement of QoL in adult eczema. We conducted a systematic literature search in PubMed and Embase identifying studies on measurement properties of adult eczema QoL instruments. For all eligible studies, we assessed the adequacy of the measurement properties and the methodological quality with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. A best evidence synthesis summarizing findings from different studies was the basis to assign four degrees of recommendation (A-D). A total of 15 articles reporting on 17 instruments were included. No instrument fulfilled the criteria for category A. Six instruments were placed in category B, meaning that they have the potential to be recommended depending on the results of further validation studies. Three instruments had poor adequacy in at least one required adequacy criterion and were therefore put in category C. The remaining eight instruments were minimally validated and were thus placed in category D. Currently, no QoL instrument can be recommended for use in adult eczema. The Quality of Life Index for Atopic Dermatitis (QoLIAD) and the Dermatology Life Quality Index (DLQI) are recommended for further validation research. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  15. Effect of geotropism on instrument readings

    International Nuclear Information System (INIS)

    Rolph, James T.

    2006-01-01

    A review of gravity's effect on instrument readings, also referred to as geotropism. In this essay a review of meter movement construction and the effect are reviewed as it applies to portable radiation instruments. Reference to the three ANSI standards and their requirements are reviewed. An alternate approach to test for the effects is offered

  16. 17 CFR 201.420 - Appeal of determinations by self-regulatory organizations.

    Science.gov (United States)

    2010-04-01

    ... self-regulatory organizations. 201.420 Section 201.420 Commodity and Securities Exchanges SECURITIES... Review § 201.420 Appeal of determinations by self-regulatory organizations. (a) Application for review... by a self-regulatory organization determination as to which a notice is required to be filed with the...

  17. Which Instruments Can Detect Submaximal Physical and Functional Capacity in Patients With Chronic Nonspecific Back Pain? A Systematic Review

    NARCIS (Netherlands)

    van der Meer, Suzan; Trippolini, Maurizio A.; van der Palen, Job; Verhoeven, Jan; Reneman, Michiel F.

    2013-01-01

    Study Design. Systematic review. Objective. To evaluate the validity of instruments that claim to detect submaximal capacity when maximal capacity is requested in patients with chronic nonspecific musculoskeletal pain. Summary of Background Data. Several instruments have been developed to measure

  18. Meteorological instrumentation for nuclear facilities

    International Nuclear Information System (INIS)

    Costa, A.C.L. da.

    1983-01-01

    The main requirements of regulatory agencies, concerning the meteorological instrumentation needed for the licensing of nuclear facilities are discussed. A description is made of the operational principles of sensors for the various meteorological parameters and associated electronic systems. An analysis of the problems associated with grounding of a typical meteorological station is presented. (Author) [pt

  19. Hydropower Regulatory and Permitting Information Desktop (RAPID) Toolkit

    Energy Technology Data Exchange (ETDEWEB)

    Levine, Aaron L [National Renewable Energy Laboratory (NREL), Golden, CO (United States)

    2017-12-19

    Hydropower Regulatory and Permitting Information Desktop (RAPID) Toolkit presentation from the WPTO FY14-FY16 Peer Review. The toolkit is aimed at regulatory agencies, consultants, project developers, the public, and any other party interested in learning more about the hydropower regulatory process.

  20. MDEP Common Position No EPR-01 - Common positions on the EPR instrumentation and controls design

    International Nuclear Information System (INIS)

    2010-01-01

    The purpose of the EPR Working Group (EPRWG) of the Multinational Design Evaluation Program (MDEP) is to identify common positions among the regulators reviewing the EPR Instrumentation and Controls (I and C) Systems in order to: 1. Promote understanding of each country 's regulatory decisions and basis for the decisions, 2. Enhance communication among the members and with external stakeholders, 3. Identify areas where harmonization and convergence of regulations, standards, and guidance can be achieved or improved, and 4. Supports standardization of new reactor designs. Since January 2008, the EPR I and C Technical Expert Subgroup (TESG) members met five times to exchange information regarding their country 's review of the EPR I and C design. The EPR I and C TESG consists of regulators from China, Canada, Finland, France, the United Kingdom, and the United States. The information exchange includes presentation of each country 's review status and technical issues, sharing of guidance documents, and sharing of regulatory decision documents. The TESG focused on the following four core areas of the EPR I and C design: 1. I and C System Independence (particularly for data communications), 2. Level of Defense and Diversity (back-up systems), 3. Qualification/quality of digital platforms, 4. Categorization/classification of systems and functions. As meetings were conducted, some areas were emphasized more depending on the significance of the issues for each country. During the TESG interactions, it became apparent that there were aspects of the EPR design where the countries had common agreement. On November 2, 2009, three of the subgroup countries, France, Finland and the United Kingdom, issued a joint regulatory position on the EPR I and C design as result of the 'Groupe Permanent' meeting in France. This statement of common positions expands upon that joint regulatory position

  1. Regulatory review - on the brink of renewal

    International Nuclear Information System (INIS)

    Braunstein, L.A.

    1993-01-01

    Under the Atomic Energy Act of 1954, US commercial nuclear energy plants are licensed to operate for 40 years each. Congress selected the 40-year term not on the basis of safety, technical, or environmental issues, but on the basis of the 40-year amortization period generally used by electric utilities for large capital investments. And nuclear power plants may apply to have their licenses renewed. Licenses for about 47 plants - totalling about 34,000 megawatts (MW) of capacity - will expire between 2000 and 2014. By 2000, 63 reactors will be more than 20 years old. Without license renewal, utilities would have to retire about 5,000 MW of capacity every year between 2010 and 2030. Moreover, the Department of Energy (DOE) estimates that renewing licenses of existing nuclear plants for 20 years would save the nation's consumers about $350 billion. The NRC has concluded that the current safety of plants, as they operate today, is adequate. Therefore, in promulgating the final rule, the commission wanted to ensure that the applicants address those technical matters that are unique to the period of plant operation beyond the initial 40 years. For this reason, the rule includes language stating that the relicensing process would examine age-related degradation unique to license renewal. Interpretation of this language is adding regulatory uncertainty to the license renewal process. NRC is reviewing its interpretation; it also has indicated that it would like to smooth out the process through the review of an actual renewal application. Utility executives, however, seem unwilling to make proposals to their boards to commit large capital investments without a clear end-point in sight. It appears that the industry is now hesitating at the renewal office door - with NRC waiting for an application, and the industry holding back

  2. Yellin's review of the Nuclear Regulatory Commission's Reactor Safety Study: comment

    International Nuclear Information System (INIS)

    Wilson, R.

    1976-01-01

    Joel Yellin (Bell J. Economics, Vol. 7, No. 1 (Spr. 1976)) reviewed the Reactor Safety Study (WASH-1400, or Rasmussen Report) published by the Nuclear Regulatory Commission and makes several criticisms. Wilson finds that some of these criticisms are much overstated, while others, although valid, are mainly criticisms of presentation. To be useful for public policy, reactor risks--and indeed all nuclear risks--must be compared with other risks society faces. Wilson feels that the Rasmussen Report is weak in these comparisons, primarily because there exist few estimates of risk in other places, but that the comparisons he does make indeed confirm that the risk is smaller than Yellin suggests. 20 references

  3. Reliability and Validity of Survey Instruments to Measure Work-Related Fatigue in the Emergency Medical Services Setting: A Systematic Review.

    Science.gov (United States)

    Patterson, P Daniel; Weaver, Matthew D; Fabio, Anthony; Teasley, Ellen M; Renn, Megan L; Curtis, Brett R; Matthews, Margaret E; Kroemer, Andrew J; Xun, Xiaoshuang; Bizhanova, Zhadyra; Weiss, Patricia M; Sequeira, Denisse J; Coppler, Patrick J; Lang, Eddy S; Higgins, J Stephen

    2018-02-15

    This study sought to systematically search the literature to identify reliable and valid survey instruments for fatigue measurement in the Emergency Medical Services (EMS) occupational setting. A systematic review study design was used and searched six databases, including one website. The research question guiding the search was developed a priori and registered with the PROSPERO database of systematic reviews: "Are there reliable and valid instruments for measuring fatigue among EMS personnel?" (2016:CRD42016040097). The primary outcome of interest was criterion-related validity. Important outcomes of interest included reliability (e.g., internal consistency), and indicators of sensitivity and specificity. Members of the research team independently screened records from the databases. Full-text articles were evaluated by adapting the Bolster and Rourke system for categorizing findings of systematic reviews, and the rated data abstracted from the body of literature as favorable, unfavorable, mixed/inconclusive, or no impact. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology was used to evaluate the quality of evidence. The search strategy yielded 1,257 unique records. Thirty-four unique experimental and non-experimental studies were determined relevant following full-text review. Nineteen studies reported on the reliability and/or validity of ten different fatigue survey instruments. Eighteen different studies evaluated the reliability and/or validity of four different sleepiness survey instruments. None of the retained studies reported sensitivity or specificity. Evidence quality was rated as very low across all outcomes. In this systematic review, limited evidence of the reliability and validity of 14 different survey instruments to assess the fatigue and/or sleepiness status of EMS personnel and related shift worker groups was identified.

  4. The impact of the long-term playing of musical instruments on the stomatognathic system - review.

    Science.gov (United States)

    Głowacka, Arleta; Matthews-Kozanecka, Maja; Kawala, Maciej; Kawala, Beata

    2014-01-01

    In this article, we have made a review of the influence of playing musical instruments on the formation of malocclusion and TMJ disorders in musicians. Primary attention was paid to the effects of wind and stringed instruments. The aim of the article was the presentation of research and opinions about this problem in the last 25 years. It is reported that long-term and repetitive playing of musical instruments, particularly stringed (violin and viola) and wind instruments can cause dysfunctions of the stomatognathic system. The impact of wind instruments was assessed in terms of the type of mouthpiece. We studied the possibility of repositioning the front teeth and reducing the width of the upper dental arch and overbite. There were also reports on the use of a specific instrument to improve the child's occlusion. Studies have also been performed on the usefulness of relaxation plates in order to improve, and even prevent, dysfunction caused by the constant stress on the same parts of the stomatognathic system. The experiments were mainly based on interviews, dental cast analyses and cephalometric analyses. Additional methods were dynamometer tests and muscle tension palpation.

  5. New technology in nuclear power plant instrumentation and control

    International Nuclear Information System (INIS)

    Anon.

    1985-01-01

    The primary topic of this book is what can be done to improve nuclear power plant operation safety and the economic benefits that can be gained with the utilization of advance instrumentation and control technology. Other topics discussed are the industry's reluctance to accept new designs determining cost effective improvements, and difficulties in meeting regulatory standards with new technology control. The subjects will be useful when considering the area of instrumentation and control for enhancing plant operation and safety. Contents: Advanced Instrumention, Plant Control and Monitoring, Plant Diagnostics and Failure Detection, Human Factors Considerations in Instrumentation and Control, NRC and Industry Perspective on Advanced Instrumentation and Control

  6. Meteorological instrumentation for nuclear installations

    International Nuclear Information System (INIS)

    Costa, A.C.L. da.

    1983-01-01

    The main requirements of regulatory agencies, concerning the meteorological instrumentation needed for the licensing of nuclear facilities are discussed. A description is made of the operational principles of sensors for the various meteorological parameters and associated electronic systems. Finally, it is presented an analysis of the problems associated with grounding of a typical meteorological station. (Author) [pt

  7. Analysis of instrumentation technology for SMART

    International Nuclear Information System (INIS)

    Hur, Seop; Koo, I. S.; Park, H. Y.; Lee, C. K.; Kim, D. H.; Suh, Y. S.; Seong, S. H.; Jang, G. S.

    1998-03-01

    It is necessary that development requirements, techniques to be developed, and development tasks and approach are established to develop the SMART instrumentation system. It is important to establish the development strategies for input for developing SMART instrumentation system. To meet above needs, the industry general and nuclear instrumentation techniques were analyzed and reviewed, respectively, based on the classification of instrumentation to analyze the industrial instrumentation techniques, and analysis results which described the inherent merits and demerits of each technique can be used for inputs to select the instruments for SMART. For the instrumentation techniques for nuclear environments, the major instrumentation techniques were reviewed, and the instrumentation system were established. The following development approaches were established based on the development requirements and the analysis results of research and development trends of industrial and nuclear instrumentation techniques. (author). 90 refs., 38 tabs., 33 figs

  8. Origins, transformations and key foci in instrumental genesis

    DEFF Research Database (Denmark)

    Tamborg, Andreas Lindenskov

    This paper investigates the origins of the instrumental genesis and instrumental orchestrations frameworks. This is done by reviewing instrumented activity situations, instrumental genesis, and instrumental orchestrations with the purpose of identifying their epistemological assumptions, what the...... and instrumental orchestrations have potential shortcomings since the technologies that currently exist in school contexts are rather different from the technologies instrumental genesis was originally developed to study.......This paper investigates the origins of the instrumental genesis and instrumental orchestrations frameworks. This is done by reviewing instrumented activity situations, instrumental genesis, and instrumental orchestrations with the purpose of identifying their epistemological assumptions, what...

  9. Measurement properties of instruments that assess participation in young people with autism spectrum disorder: a systematic review.

    Science.gov (United States)

    Lami, Francesca; Egberts, Kristine; Ure, Alexandra; Conroy, Rowena; Williams, Katrina

    2018-03-01

    To systematically review the measurement properties of instruments assessing participation in young people with autism spectrum disorder (ASD). A search was performed in MEDLINE, PsycINFO, and PubMed combining three constructs ('ASD', 'test of participation', 'measurement properties'). Results were restricted to articles including people aged 6 to 29 years. The 2539 identified articles were independently screened by two reviewers. For the included articles, data were extracted using standard forms and their risk of bias was assessed. Nine studies (8 cross-sectional) met the inclusion criteria, providing information on seven different instruments. The total sample included 634 participants, with sex available for 600 (males=494; females=106) and age available for 570, with mean age for these participants 140.58 months (SD=9.11; range=36-624). Included instruments were the school function assessment, vocational index, children's assessment of participation and enjoyment/preferences for activities of children, experience sampling method, Pediatric Evaluation of Disability Inventory, Computer Adaptive Test, adolescent and young adult activity card sort, and Patient-Reported Outcomes Measurement Information System parent-proxy peer relationships. Seven studies assessed reliability and validity; good properties were reported for half of the instruments considered. Most studies (n=6) had high risk of bias. Overall the quality of the evidence for each tool was limited. Validation of these instruments, or others that comprehensively assess participation, is needed. Future studies should follow recommended methodological standards. Seven instruments have been used to assess participation in young people with autism. One instrument, with excellent measurement properties in one study, does not comprehensively assess participation. Studies of three instruments that incorporate a more comprehensive assessment of participation have methodological limitations. Overall, limited

  10. On-line testing of nuclear plant temperature and pressure instrumentation and other critical plant equipment. IAEA regional workshop. Working material

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1999-12-31

    Under European regional TC project RER/4/011, IAEA and VUJE Training centre organized a workshop on On-line Testing of Nuclear Power Plant Temperature and Pressure Instrumentation and Other Critical Plant Equipment in Trnava, Slovak Republic, from 25 to 29 May 1998. The objective of the workshop was to review the state-of-the-art in NPP instrumentation, cover typical instrumentation problems and solutions, describe technical and regulatory requirements for verifying the performance of nuclear power plant instrumentation, describe new methods developed and applied in NPPs for on-line verification and performance of instrumentation and present new techniques using existing instrumentation to identify the on-set problems in the plant electrical, mechanical and thermal hydraulic systems. Particular emphasis was placed on temperature measurements by Resistance Temperature Detectors (RTDs) and thermocouples and pressure measurements using motion-balanced and forced-balanced pressure transmitters. This proceedings includes papers presented by the invited speakers and the participants each with an abstract as wells as a summary of the Round-Table discussions Refs, figs, tabs

  11. On-line testing of nuclear plant temperature and pressure instrumentation and other critical plant equipment. IAEA regional workshop. Working material

    International Nuclear Information System (INIS)

    1998-01-01

    Under European regional TC project RER/4/011, IAEA and VUJE Training centre organized a workshop on On-line Testing of Nuclear Power Plant Temperature and Pressure Instrumentation and Other Critical Plant Equipment in Trnava, Slovak Republic, from 25 to 29 May 1998. The objective of the workshop was to review the state-of-the-art in NPP instrumentation, cover typical instrumentation problems and solutions, describe technical and regulatory requirements for verifying the performance of nuclear power plant instrumentation, describe new methods developed and applied in NPPs for on-line verification and performance of instrumentation and present new techniques using existing instrumentation to identify the on-set problems in the plant electrical, mechanical and thermal hydraulic systems. Particular emphasis was placed on temperature measurements by Resistance Temperature Detectors (RTDs) and thermocouples and pressure measurements using motion-balanced and forced-balanced pressure transmitters. This proceedings includes papers presented by the invited speakers and the participants each with an abstract as wells as a summary of the Round-Table discussions

  12. Response of Nuclear Power Plant Instrumentation Cables Exposed to Fire Conditions.

    Energy Technology Data Exchange (ETDEWEB)

    Muna, Alice Baca [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); LaFleur, Chris Bensdotter [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Brooks, Dusty Marie [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2017-09-01

    This report presents the results of instrumentation cable tests sponsored by the US Nuclear Regulatory Commission (NRC) Office of Nuclear Regulatory Research and performed at Sandia National Laboratories (SNL). The goal of the tests was to assess thermal and electrical response behavior under fire-exposure conditions for instrumentation cables and circuits. The test objective was to assess how severe radiant heating conditions surrounding an instrumentation cable affect current or voltage signals in an instrumentation circuit. A total of thirty-nine small-scale tests were conducted. Ten different instrumentation cables were tested, ranging from one conductor to eight-twisted pairs. Because the focus of the tests was thermoset (TS) cables, only two of the ten cables had thermoplastic (TP) insulation and jacket material and the remaining eight cables were one of three different TS insulation and jacket material. Two instrumentation cables from previous cable fire testing were included, one TS and one TP. Three test circuits were used to simulate instrumentation circuits present in nuclear power plants: a 4–20 mA current loop, a 10–50 mA current loop and a 1–5 VDC voltage loop. A regression analysis was conducted to determine key variables affecting signal leakage time.

  13. Improving nuclear regulatory effectiveness

    International Nuclear Information System (INIS)

    2001-01-01

    Ensuring that nuclear installations are operated and maintained in such a way that their impact on public health and safety is as low as reasonably practicable has been and will continue to be the cornerstone of nuclear regulation. In the past, nuclear incidents provided the main impetus for regulatory change. Today, economic factors, deregulation, technological advancements, government oversight and the general requirements for openness and accountability are leading regulatory bodies to review their effectiveness. In addition, seeking to enhance the present level of nuclear safety by continuously improving the effectiveness of regulatory bodies is seen as one of the ways to strengthen public confidence in the regulatory systems. This report covers the basic concepts underlying nuclear regulatory effectiveness, advances being made and future requirements. The intended audience is primarily nuclear safety regulators, but government authorities, nuclear power plant operators and the general public may also be interested. (author)

  14. 75 FR 34749 - Determination of Regulatory Review Period for Purposes of Patent Extension; BYSTOLIC; U.S. Patent...

    Science.gov (United States)

    2010-06-18

    ... and FDA-2008-E-0267] Determination of Regulatory Review Period for Purposes of Patent Extension; BYSTOLIC; U.S. Patent Nos. 5,759,580 and 6,545,040 AGENCY: Food and Drug Administration, HHS. ACTION... determination because of the submission of applications to the Director of Patents and Trademarks, Department of...

  15. Instruments used to assess functional limitations in workers applying for disability benefit : a systematic review

    NARCIS (Netherlands)

    Spanjer, Jerry; Groothoff, Johan W.; Brouwer, Sandra

    2011-01-01

    Purpose. To systematically review the quality of the psychometric properties of instruments for assessing functional limitations in workers applying for disability benefit. Method. Electronic searches of Medline, Embase, CINAHL and PsycINFO were performed to identify studies focusing on the

  16. 17 CFR 201.421 - Commission consideration of determinations by self-regulatory organizations.

    Science.gov (United States)

    2010-04-01

    ... determinations by self-regulatory organizations. 201.421 Section 201.421 Commodity and Securities Exchanges... Commission Review § 201.421 Commission consideration of determinations by self-regulatory organizations. (a..., order review of any determination by a self-regulatory organization that could be subject to an...

  17. A review of modern instrumental methods of elemental analysis of petroleum related material. Part 2

    International Nuclear Information System (INIS)

    Nadkarni, R.A.

    1991-01-01

    In this paper a review is presented of the state of the art in elemental analysis of petroleum-related materials (crude oil, gasoline, additives, and lubricants) using modern instrumental analysis techniques. The major instrumental techniques used for elemental analysis of petroleum products include atomic absorption spectrometry (both with flame and with graphite furnace atomizer), inductively coupled plasma atomic emission spectrometry, ion chromatography, microelemental methods, neutron activation, spark source mass spectrometry, and x-ray fluorescence. Each of these techniques is compared for its advantages, disadvantages, and typical applications in the petroleum field

  18. A systematic review of instruments to assess organizational readiness for knowledge translation in health care.

    Directory of Open Access Journals (Sweden)

    Marie-Pierre Gagnon

    Full Text Available The translation of research into practices has been incomplete. Organizational readiness for change (ORC is a potential facilitator of effective knowledge translation (KT. However we know little about the best way to assess ORC. Therefore, we sought to systematically review ORC measurement instruments.We searched for published studies in bibliographic databases (Pubmed, Embase, CINAHL, PsychINFO, Web of Science, etc. up to November 1st, 2012. We included publications that developed ORC measures and/or empirically assessed ORC using an instrument at the organizational level in the health care context. We excluded articles if they did not refer specifically to ORC, did not concern the health care domain or were limited to individual-level change readiness. We focused on identifying the psychometric properties of instruments that were developed to assess readiness in an organization prior to implementing KT interventions in health care. We used the Standards for Educational and Psychological Testing to assess the psychometric properties of identified ORC measurement instruments.We found 26 eligible instruments described in 39 publications. According to the Standards for Educational and Psychological Testing, 18 (69% of a total of 26 measurement instruments presented both validity and reliability criteria. The Texas Christian University -ORC (TCU-ORC scale reported the highest instrument validity with a score of 4 out of 4. Only one instrument, namely the Modified Texas Christian University - Director version (TCU-ORC-D, reported a reliability score of 2 out of 3. No information was provided regarding the reliability and validity of five (19% instruments.Our findings indicate that there are few valid and reliable ORC measurement instruments that could be applied to KT in the health care sector. The TCU-ORC instrument presents the best evidence in terms of validity testing. Future studies using this instrument could provide more knowledge on its

  19. Assessment of the wish to hasten death in patients with advanced disease: A systematic review of measurement instruments.

    Science.gov (United States)

    Bellido-Pérez, Mercedes; Monforte-Royo, Cristina; Tomás-Sábado, Joaquín; Porta-Sales, Josep; Balaguer, Albert

    2017-06-01

    Patients with advanced conditions may present a wish to hasten death. Assessing this wish is complex due to the nature of the phenomenon and the difficulty of conceptualising it. To identify and analyse existing instruments for assessing the wish to hasten death and to rate their reported psychometric properties. Systematic review based on PRISMA guidelines. The COnsensus-based Standards for the selection of health Measurement INstruments checklist was used to evaluate the methodological quality of validation studies and the measurement properties of the instrument described. The CINAHL, PsycINFO, Pubmed and Web of Science databases were searched from inception to November 2015. A total of 50 articles involving assessment of the wish to hasten death were included. Eight concerned instrument validation and were evaluated using COnsensus-based Standards for the selection of health Measurement INstruments criteria. They reported data for between two and seven measurement properties, with ratings between fair and excellent. Of the seven instruments identified, the Desire for Death Rating Scale or the Schedule of Attitudes toward Hastened Death feature in 48 of the 50 articles. The Schedule of Attitudes toward Hastened Death is the most widely used and is the instrument whose psychometric properties have been most often analysed. Versions of the Schedule of Attitudes toward Hastened Death are available in five languages other than the original English. This systematic review has analysed existing instruments for assessing the wish to hasten death. It has also explored the methodological quality of studies that have examined the measurement properties of these instruments and offers ratings of the reported properties. These results will be useful to clinicians and researchers with an interest in a phenomenon of considerable relevance to advanced patients.

  20. Conduct of regulatory review and assessment during the licensing process for nuclear power plants

    International Nuclear Information System (INIS)

    1980-01-01

    This Safety Guide was prepared as part of the Agency's programme, referred to as the NUSS programme, for establishing Codes of Practice and Safety Guides relating to nuclear power plants. It supplements the Code of Practice on Governmental Organization for the Regulation of Nuclear Power Plants (IAEA Safety Series No. 50-C-G) and is concerned with the review and assessment by the regulatory body of all information submitted in support of licence applications, in the various phases of the licensing process. The purpose of the Guide is to provide information, recommendations and guidance for the conduct of these activities. The scope of the review and assessment will encompass the safety aspects of siting, construction, commissioning, operation and decommissioning of each nuclear power plant

  1. Is there an association between temporomandibular disorders and playing a musical instrument? A review of literature.

    Science.gov (United States)

    Attallah, M M; Visscher, C M; van Selms, M K A; Lobbezoo, F

    2014-07-01

    Temporomandibular disorders (TMDs) have a multifactorial etiology. Among others, parafunctions and oral habits have been suggested as important initiating and perpetuating factors. Playing a musical instrument that loads the masticatory system, like wind instruments and the violin or viola, has been suggested to be part of this group of etiological factors. However, the evidence base for this suggestion is lacking. Therefore, the aim of this study was to review the literature on the possible association between playing a musical instrument and developing and/or having a TMD. A PubMed search, using the query ['Music'(Mesh) AND 'Craniomandibular Disorders'(Mesh)], yielded 19 articles, 14 of which were included in this review. Six of 14 papers had a case-control or pre-test-post-test design; the remaining eight papers were case reports of expert opinions. The former papers were analysed and tabulated according to the PICO (Patient/population-Intervention-Control/comparison-Outcome/results) system; the latter ones were only summarised and tabulated. All articles with a case-control or pre-test-post-test design suggested a possible association between TMD and playing a musical instrument, especially the violin and viola. However, no clear-cut conclusion could be drawn as to whether playing a musical instrument is directly associated with TMD, or only in combination with other factors. More and better research on this topic is needed, as to enable a better counselling and possibly even a better treatment of the suffering musician. © 2014 John Wiley & Sons Ltd.

  2. Standard Review Plan for a petition for rulemaking on radioactive waste streams below regulatory concern: Expedited review in accordance with Appendix B to 10 CFR, Part 2

    International Nuclear Information System (INIS)

    Larkins, P.M.

    1989-10-01

    The Standard Review Plan (SRP) provides guidance to staff reviewers acting on rulemaking petitions in an expeditious manner to exempt from regulation radioactive waste determined to be Below Regulatory Concern (BRC), as called for in the Low-Level Radioactive Waste Policy Amendments Act of 1985. The review plan is designed to ensure the quality and uniformity of staff reviews and to present a well-defined basis for the staff's evaluation of BRC petitions. The plan serves to improve the understanding of the staff's review by interested members of the public and the industry. It also provides information about the BRC rulemaking process to a wider audience. 6 refs., 7 figs

  3. Instruments evaluating the self-directed learning abilities among nursing students and nurses: a systematic review of psychometric properties.

    Science.gov (United States)

    Cadorin, Lucia; Bressan, Valentina; Palese, Alvisa

    2017-11-25

    Modern healthcare institutions are continuously changing, and Self-Directed Learning (SDL) abilities are considered a prerequisite for both nursing students and nurses in order to be proactive about these demanding challenges. To date, no systematic reviews of existing instruments aimed at detecting and critically evaluating SDL abilities have been published. Therefore, the aims of this review are: 1) identify the instruments for assessment of SDL abilities among nursing students and nurses; 2) critically evaluate the methodological studies quality; and 3) compare the psychometric properties of the available instruments. A psychometric-systematic-review was performed. CDSR, CINAHL, ERIC, MEDLINE, PROSPERO, SCOPUS databases were searched without restrictions in time and setting. All primary studies involving nursing students or nurses, written in English and aimed at validating SDL assessment tools, were included. Studies retrieved were evaluated according to the COnsensus-based-Standards for the selection of health Measurement-INstruments (COSMIN) panel. Study inclusion, data extraction and quality assessment were performed by researchers independently. Eleven studies were included and four tools based on Knowles's theory have emerged: 1) the Self-Directed Learning Readiness Scale; 2) the Self-Directed Learning Readiness Scale for Nursing Education; 3) the Self-Rating Scale of Self-Directed Learning, and 4) the Self-Directed Learning Instrument. A few psychometric properties have been considered in each study, from two to four out of the ten required. The quality of the methodologies used was in general, from fair to poor with the exception of one instrument (the Self-Directed-Learning-Instrument). The psychometric proprieties that emerged across the tools were good in general: the Cronbach α was from 0.73 to 0.91; structural validities have also reported good indexes both in the explorative and in the confirmative factor analyses. On the basis of the findings

  4. Instruments evaluating the self-directed learning abilities among nursing students and nurses: a systematic review of psychometric properties

    Directory of Open Access Journals (Sweden)

    Lucia Cadorin

    2017-11-01

    Full Text Available Abstract Background Modern healthcare institutions are continuously changing, and Self-Directed Learning (SDL abilities are considered a prerequisite for both nursing students and nurses in order to be proactive about these demanding challenges. To date, no systematic reviews of existing instruments aimed at detecting and critically evaluating SDL abilities have been published. Therefore, the aims of this review are: 1 identify the instruments for assessment of SDL abilities among nursing students and nurses; 2 critically evaluate the methodological studies quality; and 3 compare the psychometric properties of the available instruments. Methods A psychometric-systematic-review was performed. CDSR, CINAHL, ERIC, MEDLINE, PROSPERO, SCOPUS databases were searched without restrictions in time and setting. All primary studies involving nursing students or nurses, written in English and aimed at validating SDL assessment tools, were included. Studies retrieved were evaluated according to the COnsensus-based-Standards for the selection of health Measurement-INstruments (COSMIN panel. Study inclusion, data extraction and quality assessment were performed by researchers independently. Results Eleven studies were included and four tools based on Knowles’s theory have emerged: 1 the Self-Directed Learning Readiness Scale; 2 the Self-Directed Learning Readiness Scale for Nursing Education; 3 the Self-Rating Scale of Self-Directed Learning, and 4 the Self-Directed Learning Instrument. A few psychometric properties have been considered in each study, from two to four out of the ten required. The quality of the methodologies used was in general, from fair to poor with the exception of one instrument (the Self-Directed-Learning-Instrument. The psychometric proprieties that emerged across the tools were good in general: the Cronbach α was from 0.73 to 0.91; structural validities have also reported good indexes both in the explorative and in the confirmative

  5. The Diagnostic Accuracy of Dementia-Screening Instruments With an Administration Time of 10 to 45 Minutes for Use in Secondary Care : A Systematic Review

    NARCIS (Netherlands)

    Appels, Bregje A.; Scherder, Erik

    Early screening for dementia is crucial for identifying reversible causes as well as managing, counseling, and other therapeutic interventions. Many reviews have compared the suitability of very brief screening instruments for use in primary care, but reviews on more extensive instruments in

  6. Learning from nuclear regulatory self-assessment. International peer review of the CSN report on lessons learnt from the essential service water system degradation event at the Vandellos nuclear power plant

    International Nuclear Information System (INIS)

    2006-01-01

    Nuclear regulatory self-assessment together with the benchmarking of regulatory practices against those of other countries operating nuclear power plants are key elements in maintaining a high level of nuclear safety. In that light, the Spanish Consejo de Seguridad Nuclear (CSN) formally asked the OECD Nuclear Energy Agency (NEA) to establish an international peer review team to assess the CSN report on the lessons learnt as a result of the 2004 Vandellos II event involving essential service water system degradation. The International Review Team considers the CSN report prepared in follow-up to the Vandellos event to be a commendable effort in regulatory self-assessment. The report, complemented by this international peer review, should enable the CSN to take appropriate action to ensure that its regulatory supervision is in line with best international practice. (authors)

  7. Regulatory viewpoint on nuclear fuel quality assurance

    International Nuclear Information System (INIS)

    Tripp, L.E.

    1976-01-01

    Considerations of the importance of fuel quality and performance to nuclear safety, ''as low reasonably achievable'' release of radioactive materials in reactor effluents, and past fuel performance problems demonstrate the need for strong regulatory input, review and inspection of nuclear fuel quality assurance programs at all levels. Such a regulatory program is being applied in the United States of America by the US Nuclear Regulatory Commission. Quality assurance requirements are contained within government regulations. Guidance on acceptable methods of implementing portions of the quality assurance program is contained within Regulatory Guides and other NRC documents. Fuel supplier quality assurance program descriptions are reviewed as a part of the reactor licensing process. Inspections of reactor licensee control of their fuel vendors as well as direct inspections of fuel vendor quality assurance programs are conducted on a regularly scheduled basis. (author)

  8. Nuclear instrumentation and measurement: a review based on the ANIMMA conferences

    Science.gov (United States)

    Giot, Michel; Vermeeren, Ludo; Lyoussi, Abdallah; Reynard-Carette, Christelle; Lhuillier, Christian; Mégret, Patrice; Deconinck, Frank; Gonçalves, Bruno Soares

    2017-12-01

    The ANIMMA conferences offer a unique opportunity to discover research carried out in all fields of nuclear measurements and instrumentation with applications extending from fundamental physics to fission and fusion reactors, medical imaging, environmental protection and homeland security. After four successful editions of the Conference, it was decided to prepare a review based to a large extent but not exclusively on the papers presented during the first four editions of the conference. This review is organized according to the measurement methodologies: neutronic, photonic, thermal, acoustic and optical measurements, as well as medical imaging and specific challenges linked to data acquisition and electronic hardening. The paper describes the main challenges justifying research in these different areas, and summarizes the recent progress reported. It offers researchers and engineers a way to quickly and efficiently access knowledge in highly specialized areas.

  9. Institutional barriers to DSM (demand side management): Reviewing the regulatory bargain

    Energy Technology Data Exchange (ETDEWEB)

    Warwick, W.M.

    1990-09-01

    The paper discusses traditional arguments for utility regulation in the context of the current utility environment. It reviews several DSM delivery options using a matrix of key financial considerations for utilities and consumers. The strengths and weaknesses of each option are discussed and an assessment of current prospects for DSM implementation is provided. The premise of the paper is that adoption of DSM by utilities and consumers has lagged because of technical and behavioral uncertainties. In addition, regulatory practices and DSM delivery mechanisms have not provided adequate means to extract the benefits of DSM and allocate the risks in a way that offers clear advantages over generating options. The paper concludes with a brief discussion of the potential for value of service approaches to resolve these problems.

  10. Calibration and assessment of electrochemical air quality sensors by co-location with regulatory-grade instruments

    Directory of Open Access Journals (Sweden)

    D. H. Hagan

    2018-01-01

    Full Text Available The use of low-cost air quality sensors for air pollution research has outpaced our understanding of their capabilities and limitations under real-world conditions, and there is thus a critical need for understanding and optimizing the performance of such sensors in the field. Here we describe the deployment, calibration, and evaluation of electrochemical sensors on the island of Hawai`i, which is an ideal test bed for characterizing such sensors due to its large and variable sulfur dioxide (SO2 levels and lack of other co-pollutants. Nine custom-built SO2 sensors were co-located with two Hawaii Department of Health Air Quality stations over the course of 5 months, enabling comparison of sensor output with regulatory-grade instruments under a range of realistic environmental conditions. Calibration using a nonparametric algorithm (k nearest neighbors was found to have excellent performance (RMSE < 7 ppb, MAE < 4 ppb, r2 > 0.997 across a wide dynamic range in SO2 (< 1 ppb, > 2 ppm. However, since nonparametric algorithms generally cannot extrapolate to conditions beyond those outside the training set, we introduce a new hybrid linear–nonparametric algorithm, enabling accurate measurements even when pollutant levels are higher than encountered during calibration. We find no significant change in instrument sensitivity toward SO2 after 18 weeks and demonstrate that calibration accuracy remains high when a sensor is calibrated at one location and then moved to another. The performance of electrochemical SO2 sensors is also strong at lower SO2 mixing ratios (< 25 ppb, for which they exhibit an error of less than 2.5 ppb. While some specific results of this study (calibration accuracy, performance of the various algorithms, etc. may differ for measurements of other pollutant species in other areas (e.g., polluted urban regions, the calibration and validation approaches described here should be widely applicable

  11. Clinical assessment of spasticity in children with cerebral palsy: a critical review of available instruments

    NARCIS (Netherlands)

    Scholtes, Vanessa A. B.; Becher, Jules G.; Beelen, Anita; Lankhorst, Gustaaf J.

    2006-01-01

    This study reviews the instruments used for the clinical assessment of spasticity in children with cerebral palsy, and evaluates their compliance with the concept of spasticity, defined as a velocity-dependent increase in muscle tone to passive stretch. Searches were performed in Medline, Embase,

  12. Technical evaluation of the electrical, instrumentation, and control design aspects of the override of containment purge valve isolation and other engineered safety feature signals for the Fort Calhoun Nuclear Power Plant

    International Nuclear Information System (INIS)

    Hackett, D.B.

    1980-01-01

    This report documents the technical evaluation of the electrical, instrumentation, and control design aspects of the override of containment purge valve isolation and other engineered safety feature signals for the Fort Calhoun nuclear power plant. The review criteria are based on IEEE Std-279-1971 requirements for the safety signals to all purge and ventilation isolation valves. This report is supplied as part of the Selected Electrical, Instrumentation, and Control Systems Issues Program being conducted for the US Nuclear Regulatory Commission by Lawrence Livermore Laboratory

  13. Instruments evaluating the quality of the clinical learning environment in nursing education: A systematic review of psychometric properties.

    Science.gov (United States)

    Mansutti, Irene; Saiani, Luisa; Grassetti, Luca; Palese, Alvisa

    2017-03-01

    The clinical learning environment is fundamental to nursing education paths, capable of affecting learning processes and outcomes. Several instruments have been developed in nursing education, aimed at evaluating the quality of the clinical learning environments; however, no systematic review of the psychometric properties and methodological quality of these studies has been performed to date. The aims of the study were: 1) to identify validated instruments evaluating the clinical learning environments in nursing education; 2) to evaluate critically the methodological quality of the psychometric property estimation used; and 3) to compare psychometric properties across the instruments available. A systematic review of the literature (using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines) and an evaluation of the methodological quality of psychometric properties (using the COnsensus-based Standards for the selection of health Measurement INstruments guidelines). The Medline and CINAHL databases were searched. Eligible studies were those that satisfied the following criteria: a) validation studies of instruments evaluating the quality of clinical learning environments; b) in nursing education; c) published in English or Italian; d) before April 2016. The included studies were evaluated for the methodological quality of the psychometric properties measured and then compared in terms of both the psychometric properties and the methodological quality of the processes used. The search strategy yielded a total of 26 studies and eight clinical learning environment evaluation instruments. A variety of psychometric properties have been estimated for each instrument, with differing qualities in the methodology used. Concept and construct validity were poorly assessed in terms of their significance and rarely judged by the target population (nursing students). Some properties were rarely considered (e.g., reliability, measurement error

  14. Safety analysis - current and future regulatory challenges

    Energy Technology Data Exchange (ETDEWEB)

    Jamieson, T., E-mail: Terry.Jamieson@cnsc-ccsn.gc.ca [Canadian Nuclear Safety Commission, Ottawa, ON (Canada)

    2015-07-01

    'Full text:' The current and future regulatory challenges associated with deterministic safety analysis are reviewed, including: 1. The CNSC's and safety control areas. 2. Traditional safety analysis approach. 3. Experience gained and impact. 4. Current analysis and regulatory approaches. 5. Current status. 6. Complexity and challenges In particular, the technical, regulatory and strategic aspects of these challenges are discussed. (author)

  15. Safety analysis - current and future regulatory challenges

    International Nuclear Information System (INIS)

    Jamieson, T.

    2015-01-01

    'Full text:' The current and future regulatory challenges associated with deterministic safety analysis are reviewed, including: 1. The CNSC's and safety control areas. 2. Traditional safety analysis approach. 3. Experience gained and impact. 4. Current analysis and regulatory approaches. 5. Current status. 6. Complexity and challenges In particular, the technical, regulatory and strategic aspects of these challenges are discussed. (author)

  16. A Structured Review of Generic and Specific Instruments for Measuring the Subjectively Assessed Quality of Life of Seniors

    Directory of Open Access Journals (Sweden)

    Monika Kacmarova

    2015-12-01

    Full Text Available The objective of the study is to offer a review of the instruments designed for measuring the subjectively assessed quality of life of seniors. At present it is possible to notice an increase of interest in the issue of the quality of life of specific groups of population; in addition, there is a large number of tools for its measuring. The aim of the present study is to provide a systematic review of generic and specific instruments for measuring quality of life of seniors which have been published in peer-reviewed journals and whose psychometric parameters have been verified. The search procedure formed a part of a larger retrieval search in which we analyzed 4829 abstracts in EBSCO and ProQuest Central full-text databases. We found 831 instruments which claimed to be measuring quality of life and were verified their reliability or validity. We identified 3 groups of instruments suitable for use in the senior age-group: generic methodologies applicable to adults in general, 7 generic tools and 9 specific tools designed exclusively for the senior age. The paper presents the measures designed for seniors who were analyzed and compared with regard to their psychometric parameters, purpose and theoretical framework utilized for their construction. In conclusion the authors of the study provide recommendations for the use of the selected methodologies for measuring the subjectively assessed quality of life of seniors.

  17. How Has CDER Prepared for the Nano Revolution? A Review of Risk Assessment, Regulatory Research, and Guidance Activities.

    Science.gov (United States)

    Tyner, Katherine M; Zheng, Nan; Choi, Stephanie; Xu, Xiaoming; Zou, Peng; Jiang, Wenlei; Guo, Changning; Cruz, Celia N

    2017-07-01

    The Nanotechnology Risk Assessment Working Group in the Center for Drug Evaluation and Research (CDER) within the United States Food and Drug Administration (FDA) was established to assess the potential impact of nanotechnology on drug products. One of the working group's major initiatives has been to conduct a comprehensive risk management exercise regarding the potential impact of nanomaterial pharmaceutical ingredients and excipients on drug product quality, safety, and efficacy. This exercise concluded that current review practices and regulatory guidance are capable of detecting and managing the potential risks to quality, safety, and efficacy when a drug product incorporates a nanomaterial. However, three risk management areas were identified for continued focus during the review of drug products containing nanomaterials: (1) the understanding of how to perform the characterization of nanomaterial properties and the analytical methods used for this characterization, (2) the adequacy of in vitro tests to evaluate drug product performance for drug products containing nanomaterials, and (3) the understanding of properties arising from nanomaterials that may result in different toxicity and biodistribution profiles for drug products containing nanomaterials. CDER continues to actively track the incorporation of nanomaterials in drug products and the methodologies used to characterize them, in order to continuously improve the readiness of our science- and risk-based review approaches. In parallel to the risk management exercise, CDER has also been supporting regulatory research in the area of nanotechnology, specifically focused on characterization, safety, and equivalence (between reference and new product) considerations. This article provides a comprehensive summary of regulatory and research efforts supported by CDER in the area of drug products containing nanomaterials and other activities supporting the development of this emerging technology.

  18. Material control in nuclear fuel fabrication facilities. Part II. Accountability, instrumentation and measurement techniques in fuel fabrication facilities

    International Nuclear Information System (INIS)

    Borgonovi, G.M.; McCartin, T.J.; McDaniel, T.; Miller, C.L.; Nguyen, T.

    1978-01-01

    This report describes the measurement techniques, the instrumentation, and the procedures used in accountability and control of nuclear materials, as they apply to fuel fabrication facilities. A general discussion is given of instrumentation and measurement techniques which are presently used being considered for fuel fabrication facilities. Those aspects which are most significant from the point of view of satisfying regulatory constraints have been emphasized. Sensors and measurement devices have been discussed, together with their interfacing into a computerized system designed to permit real-time data collection and analysis. Estimates of accuracy and precision of measurement techniques have been given, and, where applicable, estimates of associated costs have been presented. A general description of material control and accounting is also included. In this section, the general principles of nuclear material accounting have been reviewed first (closure of material balance). After a discussion of the most current techniques used to calculate the limit of error on inventory difference, a number of advanced statistical techniques are reviewed. The rest of the section deals with some regulatory aspects of data collection and analysis, for accountability purposes, and with the overall effectiveness of accountability in detecting diversion attempts in fuel fabrication facilities. A specific example of application of the accountability methods to a model fuel fabrication facility is given. The effect of random and systematic errors on the total material uncertainty has been discussed, together with the effect on uncertainty of the length of the accounting period

  19. Material control in nuclear fuel fabrication facilities. Part II. Accountability, instrumentation and measurement techniques in fuel fabrication facilities

    Energy Technology Data Exchange (ETDEWEB)

    Borgonovi, G.M.; McCartin, T.J.; McDaniel, T.; Miller, C.L.; Nguyen, T.

    1978-01-01

    This report describes the measurement techniques, the instrumentation, and the procedures used in accountability and control of nuclear materials, as they apply to fuel fabrication facilities. A general discussion is given of instrumentation and measurement techniques which are presently used being considered for fuel fabrication facilities. Those aspects which are most significant from the point of view of satisfying regulatory constraints have been emphasized. Sensors and measurement devices have been discussed, together with their interfacing into a computerized system designed to permit real-time data collection and analysis. Estimates of accuracy and precision of measurement techniques have been given, and, where applicable, estimates of associated costs have been presented. A general description of material control and accounting is also included. In this section, the general principles of nuclear material accounting have been reviewed first (closure of material balance). After a discussion of the most current techniques used to calculate the limit of error on inventory difference, a number of advanced statistical techniques are reviewed. The rest of the section deals with some regulatory aspects of data collection and analysis, for accountability purposes, and with the overall effectiveness of accountability in detecting diversion attempts in fuel fabrication facilities. A specific example of application of the accountability methods to a model fuel fabrication facility is given. The effect of random and systematic errors on the total material uncertainty has been discussed, together with the effect on uncertainty of the length of the accounting period.

  20. Inflammatory bowel disease-specific health-related quality of life instruments: a systematic review of measurement properties.

    Science.gov (United States)

    Chen, Xin-Lin; Zhong, Liang-Huan; Wen, Yi; Liu, Tian-Wen; Li, Xiao-Ying; Hou, Zheng-Kun; Hu, Yue; Mo, Chuan-Wei; Liu, Feng-Bin

    2017-09-15

    This review aims to critically appraise and compare the measurement properties of inflammatory bowel disease (IBD)-specific health-related quality of life instruments. Medline, EMBASE and ISI Web of Knowledge were searched from their inception to May 2016. IBD-specific instruments for patients with Crohn's disease, ulcerative colitis or IBD were enrolled. The basic characteristics and domains of the instruments were collected. The methodological quality of measurement properties and measurement properties of the instruments were assessed. Fifteen IBD-specific instruments were included, which included twelve instruments for adult IBD patients and three for paediatric IBD patients. All of the instruments were developed in North American and European countries. The following common domains were identified: IBD-related symptoms, physical, emotional and social domain. The methodological quality was satisfactory for content validity; fair in internal consistency, reliability, structural validity, hypotheses testing and criterion validity; and poor in measurement error, cross-cultural validity and responsiveness. For adult IBD patients, the IBDQ-32 and its short version (SIBDQ) had good measurement properties and were the most widely used worldwide. For paediatric IBD patients, the IMPACT-III had good measurement properties and had more translated versions. Most methodological quality should be promoted, especially measurement error, cross-cultural validity and responsiveness. The IBDQ-32 was the most widely used instrument with good reliability and validity, followed by the SIBDQ and IMPACT-III. Further validation studies are necessary to support the use of other instruments.

  1. The quality of instruments to assess the process of shared decision making: A systematic review

    Science.gov (United States)

    Bomhof-Roordink, Hanna; Smith, Ian P.; Scholl, Isabelle; Stiggelbout, Anne M.; Pieterse, Arwen H.

    2018-01-01

    Objective To inventory instruments assessing the process of shared decision making and appraise their measurement quality, taking into account the methodological quality of their validation studies. Methods In a systematic review we searched seven databases (PubMed, Embase, Emcare, Cochrane, PsycINFO, Web of Science, Academic Search Premier) for studies investigating instruments measuring the process of shared decision making. Per identified instrument, we assessed the level of evidence separately for 10 measurement properties following a three-step procedure: 1) appraisal of the methodological quality using the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist, 2) appraisal of the psychometric quality of the measurement property using three possible quality scores, 3) best-evidence synthesis based on the number of studies, their methodological and psychometrical quality, and the direction and consistency of the results. The study protocol was registered at PROSPERO: CRD42015023397. Results We included 51 articles describing the development and/or evaluation of 40 shared decision-making process instruments: 16 patient questionnaires, 4 provider questionnaires, 18 coding schemes and 2 instruments measuring multiple perspectives. There is an overall lack of evidence for their measurement quality, either because validation is missing or methods are poor. The best-evidence synthesis indicated positive results for a major part of instruments for content validity (50%) and structural validity (53%) if these were evaluated, but negative results for a major part of instruments when inter-rater reliability (47%) and hypotheses testing (59%) were evaluated. Conclusions Due to the lack of evidence on measurement quality, the choice for the most appropriate instrument can best be based on the instrument’s content and characteristics such as the perspective that they assess. We recommend refinement and validation of

  2. Is playing string or wind musical instruments a risk factor for temporomandibular dysfunction? A Systematic Review.

    Directory of Open Access Journals (Sweden)

    Alessandro Leite Cavalcanti

    2017-11-01

    Full Text Available Aim. Medical problems specifically affecting professional musicians are commonly mentioned in the literature. The present study is aimed to evaluate, through a systematic review, the possible association between the practice of string with bow and wind musical instruments and the occurrence of Temporomandibular Dysfunction (TMD. Methods. The search for articles was conducted in PubMed/Medline, Web of Science, Scopus, Lilacs, Cochrane Library, and Open Gray databases, and there was no restriction on language or date of publication. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA guidelines were followed. The MeSH terms used were: “music”; “temporomandibular joint”; “temporomandibular joint disorders”; “temporomandibular joint dysfunction syndrome”; and “occupational diseases”. Cross-sectional studies, case-control, cohort and clinical trials were included that involved the practice of string with bow and wind musical instruments and the occurrence of Temporomandibular Dysfunction (TMD. Articles were previously selected by title and abstract. Qualitative evaluation was done through the Newcastle-Ottawa Scale. Results. The literature search identified 732 studies, of which 10 met the inclusion criteria, nine of them cross-sectional studies and one a clinical intervention study. The TMD prevalence ranged from 47.0% to 89.0%. Recruitment of participants took place in professional schools and orchestras, and in bands of professional musicians. All studies reported associations between TMD and the practice of musical instruments, and violinists presented higher prevalence rates when compared to other instrument groups. Conclusion. All studies pointed to a possible association between TMD and the practice of string and wind musical instruments. More longitudinal and clinical trials studies are needed to verify any possible interrelationship.

  3. Seismic isolation of Advanced LIGO: Review of strategy, instrumentation and performance

    International Nuclear Information System (INIS)

    Matichard, F; Mittleman, R; Mason, K; Biscans, S; Barnum, S; Evans, M; Foley, S; Lantz, B; Celerier, C; Clark, D; DeBra, D; Kissel, J; Allwine, E; Abbott, B; Abbott, R; Abbott, S; Coyne, D; McIver, J; Birch, J; DeRosa, R

    2015-01-01

    The new generation of gravitational waves detectors require unprecedented levels of isolation from seismic noise. This article reviews the seismic isolation strategy and instrumentation developed for the Advanced LIGO observatories. It summarizes over a decade of research on active inertial isolation and shows the performance recently achieved at the Advanced LIGO observatories. The paper emphasizes the scientific and technical challenges of this endeavor and how they have been addressed. An overview of the isolation strategy is given. It combines multiple layers of passive and active inertial isolation to provide suitable rejection of seismic noise at all frequencies. A detailed presentation of the three active platforms that have been developed is given. They are the hydraulic pre-isolator, the single-stage internal isolator and the two-stage internal isolator. The architecture, instrumentation, control scheme and isolation results are presented for each of the three systems. Results show that the seismic isolation sub-system meets Advanced LIGO’s stringent requirements and robustly supports the operation of the two detectors. (paper)

  4. Telephone-based screening tools for mild cognitive impairment and dementia in aging studies: a review of validated instruments

    Directory of Open Access Journals (Sweden)

    Teresa Costa Castanho

    2014-02-01

    Full Text Available The decline of cognitive function in old age is a great challenge for modern society. The simultaneous increase in dementia and other neurodegenerative diseases justifies a growing need for accurate and valid cognitive assessment instruments. Although in-person testing is considered the most effective and preferred administration mode of assessment, it can pose not only a research difficulty in reaching large and diverse population samples, but it may also limit the assessment and follow-up of individuals with either physical or health limitations or reduced motivation. Therefore, telephone-based cognitive screening instruments pose an alternative and attractive strategy to in-person assessments. In order to give a current view of the state of the art of telephone-based tools for cognitive assessment in aging, this review highlights some of the existing instruments with particular focus on data validation, cognitive domains assessed, administration time and instrument limitations and advantages. From the review of the literature, performed using the databases EBSCO, Science Direct and PubMed, it was possible to verify that while telephone-based tools are useful in research and clinical practice, providing a promising approach, the methodologies still need refinement in the validation steps, including comparison with either single instruments or neurocognitive test batteries, to improve specificity and sensitivity to validly detect subtle changes in cognition that may precede cognitive impairment.

  5. First update to the US Nuclear Regulatory Commission's regulatory strategy for the high-level waste repository program

    International Nuclear Information System (INIS)

    Johnson, R.L.; Linehan, J.J.

    1991-01-01

    The US Nuclear Regulatory Commission (NRC) staff has updated its initial regulatory strategy for the High-Level Waste Repository Licensing Program. The update describes changes to the initial strategy and summarizes progress and future activities. This paper summarizes the first update of the regulatory strategy. In general the overall strategy of identifying and reducing uncertainties is unchanged. Identifying regulatory and institutional uncertainties is essentially complete, and therefore, the current and future emphasis is on reducing those regulatory and institutional uncertainties identified to date. The NRC staff has improved the methods of reducing regulatory uncertainties by (1) enhancing the technical basis preparation process for potential rulemakings and guidance and (2) designing a new guidance document, called a staff position, for clarifying regulatory uncertainties. For guiding the US DOE's reduction of technical uncertainties, the NRC staff will give more emphasis to prelicense application reviews and less emphasis on preparing staff technical positions

  6. Regulatory review and confidence building in post-closure safety assessments and safety cases for near surface disposal facilities-IAEA ASAM coordinated research programme

    International Nuclear Information System (INIS)

    Gonzales, A.; Simeonov, G.; Bennett, D.G.; Nys, V.; Ben Belfadhel, M.

    2005-01-01

    Some years ago, the IAEA successfully concluded a Coordinated Research Program (CRP) called Islam, which focussed on the development of an Improved Safety Assessment Methodology for near-surface radioactive waste disposal facilities. In November 2002, and as an extension of ISAM, the IAEA launched a new CRP called ASAM, designed to test the Application of the Safety Assessment Methodology by considering a range of near-surface disposal facilities. The ASAM work programme is being implemented by three application working groups and two cross-cutting working groups. The application working groups are testing the applicability of the ISAM methodology by assessing an existing disposal facility in Hungary, a copper mine in South Africa, and a hypothetical facility containing heterogenous wastes, such as disused sealed sources. The first cross-cutting working group is addressing a number of technical issues that are common to all near-surface disposal facilities, while the second group, the Regulatory Review Working Group (RRWG) is developing guidance on how to gain confidence in safety assessments and safety cases, and on how to conduct regulatory reviews of safety assessments. This paper provides a brief overview of the work being conducted by the Regulatory Review Working Group. (author)

  7. Structure and drafting of safeguards regulatory documents

    International Nuclear Information System (INIS)

    Cole, R.J.; Bennett, C.A.; Edelhertz, H.; Wood, M.T.; Brown, R.J.; Roberts, F.P.

    1977-09-01

    This study develops hypothesis about the relation between the structure and drafting of safeguards regulatory documents and the ability of document users to understand and implement them in a way that reflects the intent and requirements of the NRC. Four decisions are needed to improve communication: (1) Should improvement of safeguards regulatory documents as communication instruments be an explicit NRC program. (2) What specific methods of communication should be the focus of improvement efforts. (3) What actions to improve communications are feasible and desirable. (4) How should the NRC divide its available effort and resources among desirable actions in order to provide the most effective communication through regulatory documents. This volume contains: introduction, conceptual bases, legal requirements, targets, choice of documents, preparation of documents, readability, and further study of recommended changes in structure and drafting

  8. A Systematic Review of Instruments to Assess Organizational Readiness for Knowledge Translation in Health Care

    Science.gov (United States)

    Gagnon, Marie-Pierre; Attieh, Randa; Ghandour, El Kebir; Légaré, France; Ouimet, Mathieu; Estabrooks, Carole A.; Grimshaw, Jeremy

    2014-01-01

    Background The translation of research into practices has been incomplete. Organizational readiness for change (ORC) is a potential facilitator of effective knowledge translation (KT). However we know little about the best way to assess ORC. Therefore, we sought to systematically review ORC measurement instruments. Methods We searched for published studies in bibliographic databases (Pubmed, Embase, CINAHL, PsychINFO, Web of Science, etc.) up to November 1st, 2012. We included publications that developed ORC measures and/or empirically assessed ORC using an instrument at the organizational level in the health care context. We excluded articles if they did not refer specifically to ORC, did not concern the health care domain or were limited to individual-level change readiness. We focused on identifying the psychometric properties of instruments that were developed to assess readiness in an organization prior to implementing KT interventions in health care. We used the Standards for Educational and Psychological Testing to assess the psychometric properties of identified ORC measurement instruments. Findings We found 26 eligible instruments described in 39 publications. According to the Standards for Educational and Psychological Testing, 18 (69%) of a total of 26 measurement instruments presented both validity and reliability criteria. The Texas Christian University –ORC (TCU-ORC) scale reported the highest instrument validity with a score of 4 out of 4. Only one instrument, namely the Modified Texas Christian University – Director version (TCU-ORC-D), reported a reliability score of 2 out of 3. No information was provided regarding the reliability and validity of five (19%) instruments. Conclusion Our findings indicate that there are few valid and reliable ORC measurement instruments that could be applied to KT in the health care sector. The TCU-ORC instrument presents the best evidence in terms of validity testing. Future studies using this instrument could

  9. Instrument air system - Aging impact on system availability

    International Nuclear Information System (INIS)

    Villaran, M.; Subudhi, M.

    1989-01-01

    As part of ongoing efforts to understand and manage the effects of aging in nuclear power plants, an aging assessment was performed for the Instrument Air (IA) system, a system that has been the subject of much scrutiny in recent years. Despite its non-safety classification, instrument air has been a factor in a number of potentially serious events. This report presents the results of the assessment and discusses the impact of instrument air system aging on system availability and plant safety. This work was performed for the US Nuclear Regulatory Commission (NRC) as part of the Nuclear Plant Aging Research (NPAR) program. To perform the complex task of analyzing an entire system, the Aging and Life Extension Assessment Program (ALEAP) System Level Plan was developed by Brookhaven National Laboratory and applied successfully in previous system aging studies. The work presented herein was performed using two parallel work paths, as described in the ALEAP plant. One path used deterministic techniques to assess the impact of aging on compressed air system performance, while the second path used probabilistic methods. Results from both paths then were used to characterize aging in the instrument air system. Some conclusions from this work are: compressors, air system valves, and air dryers were found to make up the majority of failures; the effectiveness and quantity of preventive maintenance devoted to a component significantly affected the amount of failures experienced; review of compressed air system designs and studies using a PRA-based system model revealed that the redundancy of key components (compressors, dryers, IA/SA crossconnect valve) was an important factor in system availability; total loss of air events are uncommon

  10. Regulatory Framework and Radiation Protection as Basis for Evaluation

    International Nuclear Information System (INIS)

    Elegba, S.B.

    2010-01-01

    Regulatory Framework for Nuclear Safety and Radiation Protection International Instruments: Conventions; Safety Fundamentals; Codes of Conduct; Safety Requirements and Guide, and National Instruments:-Legislation; Regulations; Guidance Documents. The Sustainable Development Principle recognizes a duty to prevent undue burden and degradation of the environment for future generations. The prime responsibility for safety must rest with the person or organization responsible for facilities…that give rise to radiation risks” (IAEA Safety Fundamentals – SF-1). Compliance with regulations and requirements imposed by the Regulatory Body shall not relieve the organization of its prime responsibility for safety. The regulatory body shall establish and implement appropriate arrangements for a systematic approach to quality management which extend throughout the range of responsibilities and functions undertaken.”. The IAEA self-assessment model for a Regulatory Body is based on a three tier approach. This model is modular and can be used and adopted for implementation by any regulator at any stage of maturity “Start up”, “On the way”, “Mature” Small, medium size, big. The IAEA is required by its Statute to promote international cooperation while regulating safety is a national responsibility. However, radiation risks may transcend national borders and international cooperation that serves to promote and enhance safety globally by exchanging experience and by improving capabilities to control hazards, to prevent accidents, to respond to emergencies and to mitigate any harmful consequences

  11. Measurement properties of quality of life measurement instruments for infants, children and adolescents with eczema: protocol for a systematic review.

    Science.gov (United States)

    Heinl, Daniel; Prinsen, Cecilia A C; Drucker, Aaron M; Ofenloch, Robert; Humphreys, Rosemary; Sach, Tracey; Flohr, Carsten; Apfelbacher, Christian

    2016-02-09

    Eczema is a common chronic or chronically relapsing, inflammatory skin disease that exerts a substantial negative impact on quality of life (QoL). The Harmonising Outcome Measures for Eczema (HOME) initiative has used a consensus-based process which identified QoL as one of the four core outcome domains to be assessed in all eczema clinical trials. A number of measurement instruments exist to measure QoL in infants, children, and adolescents with eczema, and there is a great variability in both content and quality of the instruments used. Therefore, the objective of the proposed research is to comprehensively and systematically assess the measurement properties of the existing measurement instruments that were developed and/or validated for the measurement of patient-reported QoL in infants, children, and adolescents with eczema. This study is a systematic review of the measurement properties of patient-reported measures of QoL developed and/or validated for infants, children, and adolescents with eczema. A systematic literature search will be carried out in MEDLINE via PubMed and EMBASE using a selection of relevant search terms. Eligible studies will be primary empirical studies evaluating, describing, or comparing measurement properties of QoL instruments for infants, children, and adolescents with eczema. Two reviewers will independently perform eligibility assessment and data abstraction. Evidence tables will be used to record study characteristics, instrument characteristics, measurement properties, and interpretability. The adequacy of the measurement properties will be assessed using predefined criteria. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist will be used to evaluate the methodological quality of included studies. A best evidence synthesis will be undertaken if more than one study has examined a particular measurement property. The proposed systematic review will yield a comprehensive assessment

  12. Choice of outcomes and measurement instruments in randomised trials on eLearning in medical education: a systematic mapping review protocol.

    Science.gov (United States)

    Law, Gloria C; Apfelbacher, Christian; Posadzki, Pawel P; Kemp, Sandra; Tudor Car, Lorainne

    2018-05-17

    There will be a lack of 18 million healthcare workers by 2030. Multiplying the number of well-trained healthcare workers through innovative ways such as eLearning is highly recommended in solving this shortage. However, high heterogeneity of learning outcomes in eLearning systematic reviews reveals a lack of consistency and agreement on core learning outcomes in eLearning for medical education. In addition, there seems to be a lack of validity evidence for measurement instruments used in these trials. This undermines the credibility of these outcome measures and affects the ability to draw accurate and meaningful conclusions. The aim of this research is to address this issue by determining the choice of outcomes, measurement instruments and the prevalence of measurement instruments with validity evidence in randomised trials on eLearning for pre-registration medical education. We will conduct a systematic mapping and review to identify the types of outcomes, the kinds of measurement instruments and the prevalence of validity evidence among measurement instruments in eLearning randomised controlled trials (RCTs) in pre-registration medical education. The search period will be from January 1990 until August 2017. We will consider studies on eLearning for health professionals' education. Two reviewers will extract and manage data independently from the included studies. Data will be analysed and synthesised according to the aim of the review. Appropriate choice of outcomes and measurement tools is essential for ensuring high-quality research in the field of eLearning and eHealth. The results of this study could have positive implications for other eHealth interventions, including (1) improving quality and credibility of eLearning research, (2) enhancing the quality of digital medical education and (3) informing researchers, academics and curriculum developers about the types of outcomes and validity evidence for measurement instruments used in eLearning studies. The

  13. Soil–structure interaction analyses to locate nuclear power plant free-field seismic instrumentation

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, James J., E-mail: jasjjoh@aol.com [James J. Johnson and Associates, Alamo, CA (United States); Ake, Jon P. [US Nuclear Regulatory Commission, Washington, DC (United States); Maslenikov, Oleg R. [James J. Johnson and Associates, Alamo, CA (United States); Kenneally, Roger M. [Consultant, Seminole, FL (United States)

    2015-12-15

    Highlights: • Determine the location of seismic instrumentation so that recorded motion will be free-field motion. • Certified Designs of nuclear island for AP1000 and EPR; ABWR Reactor Building were analyzed. • Three site conditions and multiple recorded time histories were considered. • Instrumentation located 1-diameter from the edge of structure/foundation is adequate. • Acceptance criteria were probability of non-exceedance of response spectra values. - Abstract: The recorded earthquake ground motion at the nuclear power plant site is needed for several purposes. US Nuclear Regulatory Commission (NRC) Regulatory Guide 1.12, Nuclear Power Plant Instrumentation for Earthquakes, NRC (1997a), describes acceptable instrumentation to meet the requirements in NRC's regulations pertaining to earthquake engineering criteria for nuclear power plants. The ground motion data recorded by the free-field seismic instrumentation are used to compare the actual earthquake motion at the site with the design input motion. The result of the comparison determines if the Operating Basis Earthquake ground motion (OBE) has been exceeded and plant shutdown is required per the guidance in NRC Regulatory Guide 1.166, Pre-Earthquake Planning and Immediate Nuclear Power Plant Operator Postearthquake Actions, NRC (1979b). The free-field is defined as a location on the ground surface or in the site soil column that is sufficiently distant from the site structures to be essentially unaffected by the vibration of the site structures.

  14. International Approaches to Financial Instruments and Their Application in Ukraine

    OpenAIRE

    Viktor Zamlynskyy

    2013-01-01

    Introduction of International Financial Reporting Standards in Ukraine requires scientific and methodological study of their specific use in national practice. The essence and types of financial instruments have been researched. The regulatory support for their accounting in Ukraine has been established. The authors have analyzed the provisions of the International Financial Reporting Standards governing the financial instruments accounting, worked out characteristics of existing methodology ...

  15. A Qualitative Assessment of Current CCF Guidance Based on a Review of Safety System Digital Implementation Changes with Evolving Technology

    Energy Technology Data Exchange (ETDEWEB)

    Korsah, Kofi [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Muhlheim, Michael David [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Wood, Richard [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)

    2016-04-01

    The US Nuclear Regulatory Commission (NRC) is initiating a new rulemaking project to develop a digital system common-cause failure (CCF) rule. This rulemaking will review and modify or affirm the NRC's current digital system CCF policy as discussed in the Staff Requirements Memorandum to the Secretary of the Commission, Office of the NRC (SECY) 93-087, Policy, Technical, and Licensing Issues Pertaining to Evolutionary and Advanced Light Water Reactor (ALWR) Designs, and Branch Technical Position (BTP) 7-19, Guidance on Evaluation of Defense-in-Depth and Diversity in Digital Computer-Based Instrumentation and Control Systems, as well as Chapter 7, Instrumentation and Controls, in NRC Regulatory Guide (NUREG)-0800, Standard Review Plan for Review of Safety Analysis Reports for Nuclear Power Plants (ML033580677). The Oak Ridge National Laboratory (ORNL) is providing technical support to the NRC staff on the CCF rulemaking, and this report is one of several providing the technical basis to inform NRC staff members. For the task described in this report, ORNL examined instrumentation and controls (I&C) technology implementations in nuclear power plants in the light of current CCF guidance. The intent was to assess whether the current position on CCF is adequate given the evolutions in digital safety system implementations and, if gaps in the guidance were found, to provide recommendations as to how these gaps could be closed.

  16. NRC review of passive reactor design certification testing programs: Overview and regulatory perspective

    International Nuclear Information System (INIS)

    Levin, A.E.

    1993-01-01

    Reactor vendors are developing new designs for future deployment, including open-quotes passiveclose quotes light water reactors (LWRs), such as General Electric's (G.E.'s) simplified boiling water reactor (SBWR) and Westinghouse's AP600, which depend primarily on inherent processes, such as national convection and gravity feed, for safety injection and emergency core cooling. The U.S. Nuclear Regulatory Commission (NRC) has implemented a new process, certification of standardized reactor designs, for licensing these Plants. Part 52 of Title 10 of the Code of Federal Regulations (10CFR52) contains the requirements that vendors must meet for design certification. One important section, 10CFR52.47, reads open-quotes Certification of a standard design which . . . utilizes simplified, inherent, passive, or other innovative means to accomplish its safety functions will be granted only if: (1) The performance of each safety feature of the design has been demonstrated through either analysis, appropriate test programs, experience, or a combination thereof; (2) Interdependent effects among the safety features have been found acceptable by analysis, appropriate test programs, experience, or a combination thereof; and (3) Sufficient data exist on the safety features of the design to assess the analytical tools used for safety analyses. . . . The vendors have initiated programs to test innovative features of their designs and to develop data bases needed to validate their analytical codes, as required by the design certification rule. Accordingly, the NRC is reviewing and evaluating the vendors programs to ensure that they address adequately key issues concerning safety system performance. This paper provides an overview of the NRC's review process and regulatory perspective

  17. An improved instrument setpoint control program

    International Nuclear Information System (INIS)

    Cash, J.S. Jr.; George, R.T.; Kincaid, S.C.

    1991-01-01

    Instrument setpoints have a definite and often significant impact on plant safety, reliability, and availability. Although typically overshadowed by plant design, modification, and physical change activities, instrument setpoints can alter plant status and system operating characteristics just as significantly. Recognizing the need for a formal program that provides configuration control of instrument setpoints, provides a readily accessible and clearly documented basis for instrument setpoints, and integrates and coordinates operations, engineering, and maintenance activities that influence the basis for instrument setpoints, Philadelphia Electric Company (PECo) is developing an Improved Instrument Setpoint Control Program (IISCP) that incorporates current industry guidance and practices and state-of-the-art information systems technology. The IISCP was designed around PECo's then existing business processes for setpoint control, determination, and maintenance. A task force representing the various constituencies from both plants and the engineering and services organizations were formed to identify objectives and design features for the IISCP. Utilizing industry standards and guidance, regulatory documents, the experiences and good practices obtained from other utilities, and PECo's nuclear group strategies, objectives, and goals, specific objectives were identified to enhance the business processes

  18. Experience Transformed into Nuclear Regulatory Improvements in Russia

    International Nuclear Information System (INIS)

    Sapozhnikov, A.

    2016-01-01

    The third International Conference on Effective Nuclear Regulatory Systems (Canada, 2013) identified the main action items that should be addressed, implemented and followed up. The key technical and organizational areas important to strengthening reactor and spent fuel safety have been determined as following: • Regulatory lessons learned and actions taken (since the accident at the Fukushima Daiichi NPP); • Waste management and spent fuel safety; • Emergency management; • Emerging programmes; • Human and organizational factors, safety and security culture. Over time many activities based on results of the IAEA Integrated Regulatory Review Service in the Russian Federation, 2019, and post-mission, 2013, have been implemented. At present there is progress for the national action plan on nuclear safety, preparation and conducting of long term spent fuel management, complementary reviews for nuclear facilities other than Nuclear Power Plants, emergency exercises with the regulatory body participation, improving communication, development of national regulations and improvement of regulatory system in the whole. The regulatory body ensures assistance in development of national regulatory infrastructure, safety culture to the countries planning to construct Russian design facilities (NPPs, RRs). The report outlines the results and future actions to improve nuclear regulation based on systematic approach to safety and particularly reflects the specificity of taking measures for the research reactors. (author)

  19. 77 FR 28467 - Identifying and Reducing Regulatory Burdens

    Science.gov (United States)

    2012-05-14

    ... online wherever practicable. Sec. 3. Setting Priorities. In implementing and improving their... regulatory priorities, to promote public participation in retrospective review, to modernize our regulatory..., agencies shall give priority, consistent with law, to those initiatives that will produce significant...

  20. Psychometric properties of assessment instruments for autism spectrum disorder: a systematic review of Brazilian studies

    Directory of Open Access Journals (Sweden)

    Bárbara Backes

    2014-07-01

    Full Text Available Objective To systematically review the scientific literature on the psychometric properties of international instruments for the assessment of autism spectrum disorder (ASD in the Brazilian population. Methods A search of bibliographic references was conducted in six electronic databases: PsycINFO, PubMed, IndexPsi, Lilacs, Capes (theses and dissertations and SciELO. The studies were selected by two independent researchers. Results The procedure identified 11 studies of the Brazilian population that encompassed six ASD assessment tools. Given the information provided, the adaptation of the M-CHAT, a screening instrument, was the best conducted. All steps of the adaptation process were described and the changes made to the final version of the instrument were presented, which was not addressed in other studies. In terms of reliability, all of the instruments that assessed internal consistency showed adequate values. In addition, the ADI-R and the CARS adaptations also satisfactorily contemplated inter-rater reliability and test-retest indices, respectively. Finally, all studies aiming to validate instruments showed evidence of validity and sensitivity, and specificity values above 0.90 were observed in the ASQ, ADI-R and ABC. Conclusion Considering both the psychometric aspects and the copyright information, the screening instrument that currently appears to be best indicated for clinical and research use is the M-CHAT. It was also noticed that there are still no specific ASD diagnostic tools available for use in Brazil. This lack of diagnostic instruments consists in a critical situation for the improvement of clinical practice and the development of research in this area.

  1. IAEA Mission Says Chile Committed to Enhancing Safety, Sees Regulatory Challenges

    International Nuclear Information System (INIS)

    2018-01-01

    An International Atomic Energy Agency (IAEA) team of experts said Chile is committed to strengthening its regulatory framework for nuclear and radiation safety. To help achieve this aim, the team said the country should address challenges in some areas, including the need to ensure effective independence in regulatory decision-making. The Integrated Regulatory Review Service (IRRS) team today concluded a 12-day mission to assess the regulatory safety framework in Chile. The mission was conducted at the request of the Government and hosted by the Chilean Nuclear Energy Commission (CCHEN), which is responsible for regulatory supervision together with the Ministry of Health (MINSAL). The review mission covered all civilian nuclear and radiation source facilities and activities regulated in Chile.

  2. Regulatory issues resolved through design certification on the System 80+trademark standard plant design

    International Nuclear Information System (INIS)

    Ritterbusch, S.E.; Brinkman, C.B.

    1996-01-01

    The US Nuclear Regulatory Commission (NRC) has completed its review of the System 80+trademark Standard Plant Design, approving advanced design features and closing severe accident licensing issues. Final Design Approval was granted in July 1994. The NRC review was extensive, requiring written responses to over 4,950 questions and formal printing of over 50,000 Safety Analysis Report pages. New safety issues never before addressed in a regulatory atmosphere had to be resolved with detailed analysis and evaluation of design features. the System 80+ review demonstrated that regulatory issues can be firmly resolved only through presentation of a detailed design and completion of a comprehensive regulatory review

  3. Assessment of psychosocial outcomes in adolescents and young adults with cancer: a systematic review of available instruments

    Directory of Open Access Journals (Sweden)

    Wakefield CE

    2013-02-01

    Full Text Available Claire E Wakefield,1,2 Pandora Patterson,3 Fiona E J McDonald,3 Helen L Wilson,1,2 Esther Davis,3 Ursula M Sansom-Daly2,41School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, NSW, Australia; 2Centre for Children's Cancer and Blood Disorders, Sydney Children's Hospital, Sydney, NSW, Australia; 3CanTeen, Sydney, NSW, Australia; 4School of Psychology, University of New South Wales, Sydney, NSW, AustraliaPurpose: Given the burgeoning body of research relating to the psychosocial needs of adolescents and young adults (AYAs with cancer, this review aimed to evaluate the psychometric properties and appropriateness of the instruments available for use in this unique population. Specifically, we reviewed published instruments developed to assess psychological distress (depression, anxiety, stress, and fear of recurrence, psychological growth (resilience, posttraumatic growth, and benefit finding, unmet needs, coping, quality of life, identity, and mindfulness-based practices and skills in AYAs with cancer. Given the dearth of validated instruments targeting AYAs with cancer, this review also provides a summary of promising measures yet to be formally validated in this population.Methods: Five electronic databases were searched by a team of six researchers, and studies involving AYAs (who have or have had cancer aged 15–30 years, and published between 1982 and 2012 were reviewed. Of 410 abstracts, 7 instruments were identified as validated in this population, with a further 19 identified as promising.Results: While there are numerous scales to assess psychosocial outcomes in cancer, few have been specifically validated for AYAs affected by cancer, particularly in the domains of psychological distress, psychological growth, coping, unmet needs, and identity. There are relatively more instruments validated, or promising, for assessment of quality of life than scales for other domains.Conclusion: In the AYA context

  4. A review of instrumental variable estimators for Mendelian randomization.

    Science.gov (United States)

    Burgess, Stephen; Small, Dylan S; Thompson, Simon G

    2017-10-01

    Instrumental variable analysis is an approach for obtaining causal inferences on the effect of an exposure (risk factor) on an outcome from observational data. It has gained in popularity over the past decade with the use of genetic variants as instrumental variables, known as Mendelian randomization. An instrumental variable is associated with the exposure, but not associated with any confounder of the exposure-outcome association, nor is there any causal pathway from the instrumental variable to the outcome other than via the exposure. Under the assumption that a single instrumental variable or a set of instrumental variables for the exposure is available, the causal effect of the exposure on the outcome can be estimated. There are several methods available for instrumental variable estimation; we consider the ratio method, two-stage methods, likelihood-based methods, and semi-parametric methods. Techniques for obtaining statistical inferences and confidence intervals are presented. The statistical properties of estimates from these methods are compared, and practical advice is given about choosing a suitable analysis method. In particular, bias and coverage properties of estimators are considered, especially with weak instruments. Settings particularly relevant to Mendelian randomization are prioritized in the paper, notably the scenario of a continuous exposure and a continuous or binary outcome.

  5. Risk prediction in the community: A systematic review of case-finding instruments that predict adverse healthcare outcomes in community-dwelling older adults.

    LENUS (Irish Health Repository)

    O'Caoimh, Rónán

    2015-09-01

    Few case-finding instruments are available to community healthcare professionals. This review aims to identify short, valid instruments that detect older community-dwellers risk of four adverse outcomes: hospitalisation, functional-decline, institutionalisation and death. Data sources included PubMed and the Cochrane library. Data on outcome measures, patient and instrument characteristics, and trial quality (using the Quality In Prognosis Studies [QUIPS] tool), were double-extracted for derivation-validation studies in community-dwelling older adults (>50 years). Forty-six publications, representing 23 unique instruments, were included. Only five were externally validated. Mean patient age range was 64.2-84.6 years. Most instruments n=18, (78%) were derived in North America from secondary analysis of survey data. The majority n=12, (52%), measured more than one outcome with hospitalisation and the Probability of Repeated Admission score the most studied outcome and instrument respectively. All instruments incorporated multiple predictors. Activities of daily living n=16, (70%), was included most often. Accuracy varied according to instruments and outcomes; area under the curve of 0.60-0.73 for hospitalisation, 0.63-0.78 for functional decline, 0.70-0.74 for institutionalisation and 0.56-0.82 for death. The QUIPS tool showed that 5\\/23 instruments had low potential for bias across all domains. This review highlights the present need to develop short, reliable, valid instruments to case-find older adults at risk in the community.

  6. A study on the implement of regulatory issue problems about service business

    International Nuclear Information System (INIS)

    Kim, In Hwan; Shim, H. S.; Yoon, K. H.; Jun, I. Y.; Kang, W. S.; Chang, J. H.

    2004-12-01

    This study is intended to derive a proposal for revision of the Atomic Energy Law, with understanding of differences between regulatory requirements and current issues based on findings during safety review and regular inspection. The contents and scope of this study is as follows: - Deep review for service business in 'the rationalization of the radiation protection system related with use of radionuclide', studied by Korea Isotope Association and presentation in the Korea Association for radiation protection, - Efficient regulatory activity through pre-finding of current regulatory issues to be derived during safety review and regular inspection

  7. The Effects of Degraded Digital Instrumentation and Control Systems on Human-system Interfaces and Operator Performance: HFE Review Guidance and Technical Basis

    Energy Technology Data Exchange (ETDEWEB)

    O' Hara, J.M.; W. Gunther, G. Martinez-Guridi

    2010-02-26

    New and advanced reactors will use integrated digital instrumentation and control (I&C) systems to support operators in their monitoring and control functions. Even though digital systems are typically highly reliable, their potential for degradation or failure could significantly affect operator performance and, consequently, impact plant safety. The U.S. Nuclear Regulatory Commission (NRC) supported this research project to investigate the effects of degraded I&C systems on human performance and plant operations. The objective was to develop human factors engineering (HFE) review guidance addressing the detection and management of degraded digital I&C conditions by plant operators. We reviewed pertinent standards and guidelines, empirical studies, and plant operating experience. In addition, we conducted an evaluation of the potential effects of selected failure modes of the digital feedwater system on human-system interfaces (HSIs) and operator performance. The results indicated that I&C degradations are prevalent in plants employing digital systems and the overall effects on plant behavior can be significant, such as causing a reactor trip or causing equipment to operate unexpectedly. I&C degradations can impact the HSIs used by operators to monitor and control the plant. For example, sensor degradations can make displays difficult to interpret and can sometimes mislead operators by making it appear that a process disturbance has occurred. We used the information obtained as the technical basis upon which to develop HFE review guidance. The guidance addresses the treatment of degraded I&C conditions as part of the design process and the HSI features and functions that support operators to monitor I&C performance and manage I&C degradations when they occur. In addition, we identified topics for future research.

  8. A systematic review of instruments for assessing parent satisfaction with family-centred care in neonatal intensive care units.

    Science.gov (United States)

    Dall'Oglio, Immacolata; Mascolo, Rachele; Gawronski, Orsola; Tiozzo, Emanuela; Portanova, Anna; Ragni, Angela; Alvaro, Rosaria; Rocco, Gennaro; Latour, Jos M

    2018-03-01

    This systematic review synthesised and described instruments measuring parent satisfaction with the increasing standard practice of family-centred care (FCC) in neonatal intensive care units. We evaluated 11 studies published from January 2006 to March 2016: two studies validated a parent satisfaction questionnaire, and nine developed or modified previous questionnaires to use as outcome measures in their local settings. Most instruments were not tested on reliability and validity. Only two validated instruments included all six of the FCC principles and could assess parent satisfaction with FCC in neonatal intensive care units and be considered as outcome indicators for further research. ©2017 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

  9. Regulatory Aspect of Periodic Safety Review Performed in Nuclear Power Plants in the Slovak Republic

    International Nuclear Information System (INIS)

    Baszo, Z.

    2010-01-01

    The paper deals with the regulatory aspect of Nuclear Power Plant (NPP) Periodic Safety Review (PSR) as a part of license renewal process in the Slovak Republic. It summarizes the history of activities similar to PSR performed in the past for NPPs operated in the Slovak Republic. Furthermore, it describes both the requirements involved in the current Slovak legislation to be met by licensee in the Slovak Republic in this field and the procedures concerning the PSR as well. The objective and rules of PSR to be performed for NPPs in the Slovak Republic were derived from the internationally accepted International Atomic Energy Agency (IAEA) document and have been implemented into national legislation. PSR of two twin units located in Bohunice NPP and Mochovce NPP, respectively, has been initiated in the Slovak Republic based on evaluation of each area to be reviewed (safety factors) using recent methodology and practice. Other significant factors, such as ageing, modifications of NPP and the safe operation for a specified future period, have to be assessed in the frame of PSR. Report on performed PSR outlines the results of review for each area, the corrective plan, which considering mutual relations between assessed areas specifies the issues to be solved with the aim to eliminate shortcomings identified in the frame of PSR and to adopt safety improvements. The findings from PSR in the evaluated areas also serve as a source of information for updating of all documents to be attached to the written application of licensee for renewal of a nuclear power plant operating license. The presented procedure describes how the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) has reviewed the documents submitted during PSR. Based on results of submitted documents evaluation and licensee application for license renewal the license for next 10 years operation has been issued for Bohunice NPP. At present, similar procedure for Mochovce NPP unit 1 and 2 is underway.(author).

  10. What's the Regulatory Value of a Target Product Profile?

    Science.gov (United States)

    Breder, Christopher D; Du, Wenny; Tyndall, Adria

    2017-07-01

    Target product profiles (TPPs) are used as a regulatory tool for dialog on clinical development or manufacturing plans. Drugs and biologics approved by the FDA that mention TPPs are associated with more efficient regulatory review times, perhaps as a result of increased planning or because the TPP promotes well-organized regulatory dialog. Published by Elsevier Ltd.

  11. INSTRUMENTS OF HIGH RISK SEXUAL BEHAVIOR ASSESSMENT: A SYSTEMATIC REVIEW.

    Science.gov (United States)

    Mirzaei, Mojtaba; Ahmadi, Khodabakhsh; Saadat, Seyed-Hassan; Ramezani, Mohammad Arash

    2016-02-01

    Sexual behavior is a complex activity affecting all aspects of human's life. Risky sexual behaviors impose negative outcomes on family, relationships and health. Unsafe sex is the second most leading cause of disability adjusted life years worldwide. Valid and reliable tools for assessment of risky sexual behaviors are necessary for implementing preventive measures. we searched Medline and the Cochrane Library of Systematic Reviews, with the keywords of "risky sexual behavior assessment", "sexual risk assessment", "high risk sexual behavior", "sexual risk taking". By reviewing references of the articles, some complementary studies were added. Assessment can be performed by questionnaire or non-questionnaire instruments. Questionnaires vary depending on their target population, evaluation of risky sexual behavior as a whole or focusing on an associated risk factor. In order to avoid usual biases in self reports, objective biomarker assessment of unprotected sex are employed. These markers include prostate specific antigen, chromosome Y DNA and Seminogelin. Risky sexual behavior can be assessed by various subjective and objective methods. While self-reports are more feasible, objective methods offer a higher degree of reliability. Further studies for finding more feasible methods of using biomarkers are recommended.

  12. Regulatory research of the PWR severe accident information needs and instrumentation availability for hydrogen control and management

    Energy Technology Data Exchange (ETDEWEB)

    Park, Jae-Hong; Park, Gun-Chul; Suh, Kune Y.; Kang, Yun-Moon; Lee, Un-Jang; Oh, Se-Chul; Lee, Jin-Yong [Seoul Nationl Univ., Seoul (Korea, Republic of)

    1998-03-15

    During the current research period, we have set forth the methodology for identification of a severe accident, developed a framework for hydrogen management decision trees, and analyzed the literature on hydrogen management and experimental data for hydrogen bum. Specifically, we have summarized me results for information needs in a severe accident obtained in the U.S. and other countries, and applied the methodology to the reference plant YGN 3 and 4 as part of severe accident management. We have also examined the existing instruments in terms of their availability and survivability during a severe accident, and identified additionally needed information needs and instruments. We have identified dominant accident sequences for me reference plant YGN 3 and 4 to construct decision trees, and extracted available data from the IPE study of the plant. Based upon the data we have performed preliminary study on the decision tree and decision node. Last, we have examined various mechanisms for hydrogen generation and reIevant experimental data to predict me amount of hydrogen generation and governing factors in me process. We have also reviewed the hydrogen generation related models in the severe accident analysis.

  13. Assessment of the measurement properties of the post stroke motor function instruments available in Brazil: a systematic review.

    Science.gov (United States)

    Lima, Elaine; Teixeira-Salmela, Luci F; Simões, Luan; Guerra, Ana C C; Lemos, Andrea

    2016-03-15

    While there are several instruments in Brazil that measure motor function in patients after stroke, it is unknown whether the measurement properties of these instruments are appropriate. To identify the motor function instruments available in Brazil for patients after stroke. To assess the methodological quality of the studies and the results related to the measurement properties of these instruments. Two independent reviewers conducted searches on PubMed, LILACS, CINAHL, Web of Science, and Scopus. Studies that aimed to cross-culturally adapt an existing instrument or create a Brazilian instrument and test at least one measurement property related to motor function in patients after stroke were included. The methodological quality of these studies was checked by the COSMIN checklist with 4-point rating scale and the results of the measurement properties were analyzed by the criteria developed by Terwee et al. A total of 11 instruments were considered eligible, none of which were created in Brazil. The process of cross-cultural adaptation was inadequate in 10 out of 11 instruments due to the lack of back-translation or due to inappropriate target population. All of the instruments presented flaws in the measurement properties, especially reliability, internal consistency, and construct validity. The flaws observed in both cross-cultural adaptation process and testing measurement properties make the results inconclusive on the validity of the available instruments. Adequate procedures of cross-cultural adaptation and measurement properties of these instruments are strongly needed.

  14. Assessment of the measurement properties of the post stroke motor function instruments available in Brazil: a systematic review

    Directory of Open Access Journals (Sweden)

    Elaine Lima

    2016-01-01

    Full Text Available Background While there are several instruments in Brazil that measure motor function in patients after stroke, it is unknown whether the measurement properties of these instruments are appropriate. Objective To identify the motor function instruments available in Brazil for patients after stroke. To assess the methodological quality of the studies and the results related to the measurement properties of these instruments. Method Two independent reviewers conducted searches on PubMed, LILACS, CINAHL, Web of Science, and Scopus. Studies that aimed to cross-culturally adapt an existing instrument or create a Brazilian instrument and test at least one measurement property related to motor function in patients after stroke were included. The methodological quality of these studies was checked by the COSMIN checklist with 4-point rating scale and the results of the measurement properties were analyzed by the criteria developed by Terwee et al. Results A total of 11 instruments were considered eligible, none of which were created in Brazil. The process of cross-cultural adaptation was inadequate in 10 out of 11 instruments due to the lack of back-translation or due to inappropriate target population. All of the instruments presented flaws in the measurement properties, especially reliability, internal consistency, and construct validity. Conclusion The flaws observed in both cross-cultural adaptation process and testing measurement properties make the results inconclusive on the validity of the available instruments. Adequate procedures of cross-cultural adaptation and measurement properties of these instruments are strongly needed.

  15. Survey of instrumentation for environmental monitoring: major update. Volume 3. Radiation

    Energy Technology Data Exchange (ETDEWEB)

    1979-09-01

    This is the third volume of a four-volume (seven-part) series, the culmination of a comprehensive survey of instrumentation for environmental monitoring. Consideration is given to instruments and techniques presently in use and to those developed for other purposes but having possible applications to radiation monitoring. The results of the survey are given as descriptions of the physical and operating characteristics of available instruments, critical comparisons among instrumentation methods, and recommendations of promising methodology and development of new instrumentation. Information is also given regarding the pollutants to be monitored, their characteristics and forms, their sources and pathways, their effects on the ecosystem, and the means of controlling them through process and regulatory controls. The discussion is presented under sections entitled radiation sources; instrumentation: by type of radiation or instrument type; and, instrumentation for specific radionuclides. (JGB)

  16. Survey of instrumentation for environmental monitoring: major update. Volume 3. Radiation

    International Nuclear Information System (INIS)

    1979-09-01

    This is the third volume of a four-volume (seven-part) series, the culmination of a comprehensive survey of instrumentation for environmental monitoring. Consideration is given to instruments and techniques presently in use and to those developed for other purposes but having possible applications to radiation monitoring. The results of the survey are given as descriptions of the physical and operating characteristics of available instruments, critical comparisons among instrumentation methods, and recommendations of promising methodology and development of new instrumentation. Information is also given regarding the pollutants to be monitored, their characteristics and forms, their sources and pathways, their effects on the ecosystem, and the means of controlling them through process and regulatory controls. The discussion is presented under sections entitled radiation sources; instrumentation: by type of radiation or instrument type; and, instrumentation for specific radionuclides

  17. The IAEA Integrated Regulatory Review Service (IRRS) - Information Meeting Dublin

    International Nuclear Information System (INIS)

    Al Khatibeh, Ahmad

    2014-05-01

    IRRS is developed to help States evaluate the current status of compliance of their regulatory infrastructures for safety with IAEA Standards. This report discusses the function of IRRS missions as a tool for evaluating the regulatory structure for Member States. It was presented to RPII staff in a Powerpoint document in preparation for the IRRS Mission to Ireland in August 2015

  18. The relationship between time perspective and self-regulatory processes, abilities and outcomes: a protocol for a meta-analytical review.

    Science.gov (United States)

    Baird, Harriet M; Webb, Thomas L; Martin, Jilly; Sirois, Fuschia M

    2017-07-05

    Both theoretical and empirical evidence suggests that time perspective is likely to influence self-regulatory processes and outcomes. Despite the theoretical and practical significance of such relations, the relationship between time perspective and self-regulatory processes and outcomes across different measures, samples and life domains, including health, has yet to be explored. The proposed review will develop a taxonomy for classifying measures according to the self-regulatory process, ability or outcome that they are likely to reflect. Electronic scientific databases will be searched, along with relevant conference abstract booklets and citation lists. Additionally, a call for unpublished data will be submitted to relevant bodies. To be eligible for inclusion, studies must include a measure of time perspective and a measure of at least one self-regulatory process, ability and/ or outcome. Eligibility will not be restricted by publication date, language, type of sample or setting. The bivariate correlations will be extracted (or calculated) and submitted to a random-effects meta-analysis. The sample-weighted average effect size, heterogeneity, risk of bias and publication bias will be calculated, and the effects of categorical and continuous moderator variables on the effect sizes will be determined. The proposed meta-analysis will synthesise previously conducted research; thus, ethical approval is not required. The findings will be submitted for publication in an international peer-reviewed journal and reported as part of the first author’s PhD thesis. The findings will also be disseminated to the research community and, where appropriate, to other interested parties through presentations at relevant academic and non-academic conferences. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  19. Cost-benefit and regulatory decision making

    International Nuclear Information System (INIS)

    Harvie, J.

    1996-01-01

    The Atomic Energy Control Board is investigating the feasibility of developing methods for factoring cost-benefit considerations into its regulatory decision-making. This initiative results, in part, from the federal government policy requiring cost-benefit considerations to be taken into account in regulatory processes, and from the recommendations of an Advisory Panel on Regulatory Review in 1993, submitted to the Minister of Natural Resources Canada. One of these recommendations stated: 'that mechanisms be developed to examine cost benefit issues and work towards some consensus of opinion among stake holders: a task force on the subject could be an appropriate starting point'. (author)

  20. Diagnostic accuracy of portable instrumental devices to measure sleep bruxism: a systematic literature review of polysomnographic studies

    NARCIS (Netherlands)

    Manfredini, D.; Ahlberg, J.; Castroflorio, T.; Poggio, C.E.; Guarda-Nardini, L.; Lobbezoo, F.

    2014-01-01

    This study systematically reviews the sleep bruxism (SB) literature published in the MEDLINE and Scopus databases to answer the following question: What is the validity of the different portable instrumental devices that have been proposed to measure SB if compared with polysomnographic (PSG)

  1. International regulatory activities

    International Nuclear Information System (INIS)

    Anon.

    2009-01-01

    In this last part is reviewed international regulatory activities and bilateral agreements including two parts: concerning European atomic energy community with European commission proposal for a council directive setting up a community framework for nuclear safety, update of the nuclear illustrative programme in the context of the second strategic energy review, european commission recommendation on criteria for the export of radioactive waste and spent fuel to third countries and a communication on nuclear non-proliferation and the second part in relation with international atomic energy agency with a joint convention on the safety of spent fuel management and on safety of radioactive waste management (third review meeting). (N.C.)

  2. Upgrading nuclear regulatory infrastructure in Armenia

    International Nuclear Information System (INIS)

    Martirosyan, A.; Amirjanyan, A.; Kacenelenbogen, S.

    2010-01-01

    Armenia is contemplating an upgrade to its national power generation capacity to meet replacement and future energy needs. Unit 2 of ANPP is scheduled for shutdown after replacement power generation capacities are in place. A recent alternative energy study indicates viability of the nuclear option to replace this capacity. Some technology-specific proposals are being considered by the Ministry of Energy of Armenia. It is likely that the reactor technology decision will be made in the not too distant future. The existing reactor continues to be operated in the regulatory framework developed in the Soviet Union and adopted in Armenia. Given the interest in the new reactor, Armenia launched a project to review the existing system of regulation and to bring it into harmony with modern practice in preparation for the new reactor project development. The new regulatory framework will be needed as a basis for any potential tendering process. The US NRC and ANRA have agreed to perform a review and update nuclear legislation and the system of regulation in this area. The first step in this process was to develop an action plan for such program. The action plan describes the overall strategy of ANRA to modify existing or develop new processes and requirements, identifies the major Laws that need to be reviewed given practical legal considerations to construct and operate the reactor and Armenia's international obligations under various conventions. This work included review of existing models of regulation in different countries with 'small' nuclear program, including IAEA recommendations as well as existing legislation in Armenia in this area and development of a strategy for the regulatory model development. In addition, the plan to develop requirements for ANRA staffing and training needs to meet its regulatory obligations under the new reactor development process was developed

  3. Codes and standards and other guidance cited in regulatory documents

    International Nuclear Information System (INIS)

    Nickolaus, J.R.; Bohlander, K.L.

    1996-08-01

    As part of the U.S. Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program (SRP-UDP), Pacific Northwest National Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. The SRP-UDP has been completed and the SRP-Maintenance Program (SRP-MP) is now maintaining this listing. Besides updating previous information, Revision 3 adds approximately 80 citations. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC's Bulletins, Information Notices, Circulars, Enforcement Manual, Generic Letters, Inspection Manual, Policy Statements, Regulatory Guides, Standard Technical Specifications and the Standard Review Plan (NUREG-0800)

  4. Codes and standards and other guidance cited in regulatory documents

    Energy Technology Data Exchange (ETDEWEB)

    Nickolaus, J.R.; Bohlander, K.L.

    1996-08-01

    As part of the U.S. Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program (SRP-UDP), Pacific Northwest National Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. The SRP-UDP has been completed and the SRP-Maintenance Program (SRP-MP) is now maintaining this listing. Besides updating previous information, Revision 3 adds approximately 80 citations. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC`s Bulletins, Information Notices, Circulars, Enforcement Manual, Generic Letters, Inspection Manual, Policy Statements, Regulatory Guides, Standard Technical Specifications and the Standard Review Plan (NUREG-0800).

  5. Introduction of regulatory guide on cyber security of L and C systems in nuclear facilities

    International Nuclear Information System (INIS)

    Kang, Y.; Jeong, C. H.; Kim, D. I.

    2008-01-01

    In the case of unauthorized individuals, systems and entities or process threatening the instrumentation and control systems of nuclear facilities using the intrinsic vulnerabilities of digital based technologies, those systems may lose their own required functions. The loss of required functions of the systems can seriously affect the safety of nuclear facilities. Consequently, digital instrumentation and control systems, which perform functions important to safety, should be designed and operated to respond to cyber threats capitalizing on the vulnerabilities of digital based technologies. To make it possible, the developers and licensees of nuclear facilities should perform appropriate cyber security activities throughout the whole life cycle of digital instrumentation and control systems. Under the goal of securing the safety of nuclear facilities, this paper presents the regulatory on cyber security activities to remove the cyber threats that exploit the vulnerabilities of digital instrumentation and control systems and to mitigate the effect of such threats. Presented regulatory guide includes establishing the cyber security policy and plan, analyzing and classifying the cyber threats and cyber security assessment of digital instrumentation and control systems. (authors)

  6. Organisational reviews - requirements, methods and experience. Progress report 2006

    Energy Technology Data Exchange (ETDEWEB)

    Reiman, T.; Oedewald, P.; Wahlstroem, B. [VTT, Technical Research Centre of Finland (Finland); Rollenhagen, C.; Kahlbom, U. [Maelardalen University (FI)

    2007-04-15

    Organisational reviews are important instruments in the continuous quest for improved performance. In the nuclear field there has been an increasing regulatory interest in organisational performance, because incidents and accidents often point to organisational deficiencies as one of the major precursors. Many methods for organisational reviews have been proposed, but they are mostly based on ad hoc approaches to specific problems. The absence of well-established techniques for organisational reviews has already shown to cause discussions and controversies on different levels. The aim of the OrRe project is to collect the experiences from organisational reviews carried out so far and to reflect them in a theoretical model of organisational performance. Furthermore, the project aims to reflect on the criteria for the definition of the scope and content of organisational reviews. Finally, recommendations will be made for guidance for people participating in organisational reviews. This progress report describes regulatory practices in Finland and Sweden together with some case examples of organizational reviews and assessment in both countries. Some issues of concern are raised and an outline for the next year's work is proposed. Issues of concern include the sufficient depth of the assessment, the required competence in assessments, data and criteria problems, definition of the boundaries of the system to be assessed, and the necessary internal support and organisational maturity required for successful assessments. Finally, plans for next year's work are outlined. (au)

  7. Organisational reviews - requirements, methods and experience. Progress report 2006

    International Nuclear Information System (INIS)

    Reiman, T.; Oedewald, P.; Wahlstroem, B.; Rollenhagen, C.; Kahlbom, U.

    2007-04-01

    Organisational reviews are important instruments in the continuous quest for improved performance. In the nuclear field there has been an increasing regulatory interest in organisational performance, because incidents and accidents often point to organisational deficiencies as one of the major precursors. Many methods for organisational reviews have been proposed, but they are mostly based on ad hoc approaches to specific problems. The absence of well-established techniques for organisational reviews has already shown to cause discussions and controversies on different levels. The aim of the OrRe project is to collect the experiences from organisational reviews carried out so far and to reflect them in a theoretical model of organisational performance. Furthermore, the project aims to reflect on the criteria for the definition of the scope and content of organisational reviews. Finally, recommendations will be made for guidance for people participating in organisational reviews. This progress report describes regulatory practices in Finland and Sweden together with some case examples of organizational reviews and assessment in both countries. Some issues of concern are raised and an outline for the next year's work is proposed. Issues of concern include the sufficient depth of the assessment, the required competence in assessments, data and criteria problems, definition of the boundaries of the system to be assessed, and the necessary internal support and organisational maturity required for successful assessments. Finally, plans for next year's work are outlined. (au)

  8. Structure and drafting of safeguards regulatory documents

    International Nuclear Information System (INIS)

    Cole, R.J.; Bennett, C.A.; Edelhertz, H.; Wood, M.T.; Brown, R.J.; Roberts, F.P.

    1977-09-01

    Improving communication of NRU's requirements is the subject of this study. This summary is organized in terms of four decisions on whether safeguards regulatory documents as communication instruments should be an explicit NRC program, what communication methods should be focused on, what actions are feasible and desirable, and how should the NRC divide its effort and resources among desirable actions

  9. INSTRUMENTATION FOR ENVIRONMENTAL MONITORING--Radiation--Vol3Pt1

    Energy Technology Data Exchange (ETDEWEB)

    Authors, Various

    1972-01-02

    A comprehensive survey of instrumentation for environmental monitoring is being carried out by the Lawrence Berkeley Laboratory originally under a grant from the National Science Foundation and now by the Office of Health and Environmental Research of the Department of Energy. Instruments being investigated are those useful for measurements in Air Quality, Water Quality, Radiation, and Biomedicine related to environmental research and monitoring. Consideration is given to instruments and techniques presently in use and to those developed for other purposes but having possible applications to this work. The results of the survey are given as (a) descriptions of the physical and operating characteristics of available instruments, (b) critical comparisons among instrumentation methods, and (c) recommendations of promising methodology and development of new instrumentation. Information is also given regarding the pollutants to be monitored: their characteristics and forms, their sources and pathways, their effects on the ecosystem, and the means of controlling them through process and regulatory controls.

  10. Resolution of digital instrumentation and control and human factors technical and regulatory issues for new plants and for modernization of operating plants

    International Nuclear Information System (INIS)

    Naser, J.A.; Torok, R.C.; Canavan, K.T.

    2008-01-01

    There are several technical and regulatory issues in the areas of digital I and C, human factors, and control rooms needing generic resolution. If they are not generically resolved, they can contribute to protracted regulatory reviews for operating plant license amendments and substantial delays and increased costs for new plant COL approvals. Therefore; a coordinated, proactive program has been established to resolve key issues. Both Industry and NRC have roles in resolving these key issues and addressing them in future design efforts and regulatory reviews. The Industry initiative is led by the NEI Digital I and C and Human Factors Working Group. NRC has established Task Working Groups under the NRC Digital I and C Steering Committee to address the issues and interact with Industry. EPRI is providing technical input and resolution leadership for some of the issues being addressed in three of the task working groups. For the Highly Integrated Control Room - Human Factors Task area, EPRI has taken the lead in developing draft industry position technical reports for the following three issues: 1) Minimum inventory of human system interfaces, 2) Computerized procedures and associated topics of automation and soft controls, and 3) Methodology to determine the acceptability of manual operator actions response times for a BTP 7-19 software common cause failure. For the Diversity and Defense-in-Depth area, EPRI has taken the lead in developing two draft industry position technical papers on the following topics: 1) Integrating defensive measures and diversity attributes to protect against digital common cause failures and 2) Susceptibility of digital devices and components to common cause failures. For the Risk Informing area, EPRI has taken the lead in developing two draft industry position technical papers on the following topics: 1) Clarifying how to use current methods to model digital systems in a PRA and 2) Application of PRA to specific digital I and C issues

  11. PKC-theta in regulatory and effector T-cell functions

    Directory of Open Access Journals (Sweden)

    Vedran eBrezar

    2015-10-01

    Full Text Available One of the major goals in immunology research is to understand the regulatory mechanisms that underpin the rapid switch on/off of robust and efficient effector (Teff or regulatory (Tregs T-cell responses. Understanding the molecular mechanisms underlying the regulation of such responses is critical for the development of effective therapies. T-cell activation involves the engagement of T-cell receptor and co-stimulatory signals, but the subsequent recruitment of serine/threonine-specific protein Kinase C-theta (PKC-θ to the immunological synapse is instrumental for the formation of signalling complexes, that ultimately lead to a transcriptional network in T cells. Recent studies demonstrated that major differences between Teffs and Tregs occurred at the immunological synapse where its formation induces altered signalling pathways in Tregs. These pathways are characterized by reduced recruitment of PKC-θ, suggesting that PKC-θ inhibits Tregs suppressive function in a negative feedback loop. As the balance of Teffs and Tregs has been shown to be central in several diseases, it was not surprising that some studies revealed that PKC-θ plays a major role in the regulation of this balance.This review will examine recent knowledge on the role of PKC-θ in T-cell transcriptional responses and how this protein can impact on the function of both Tregs and Teffs.

  12. Review on the worldwide regulatory framework for biosimilars focusing on the Mexican case as an emerging market in Latin America.

    Science.gov (United States)

    Ibarra-Cabrera, Ricardo; Mena-Pérez, Sandra Carolina; Bondani-Guasti, Augusto; García-Arrazola, Roeb

    2013-12-01

    The global biopharmaceutical market is worth over $100 billion USD. Nearly 90% of these products will lose their patent in the next ten years, leading to the commercialization of their subsequent versions, known as 'biosimilars'. Biosimilars are much more complex molecules than chemically synthesized generics in terms of size, structure, stability, microheterogeneity, manufacture, etc. Therefore, a specific regulatory framework is needed in order to demonstrate their comparability with innovative products, as well as their quality, safety and efficacy. The EU published the first regulatory pathway in 2005 and has approved 14 biosimilars. Mexico has recently developed a clear regulatory pathway for these products. Their legal basis was established in Article 222 Bis of General Law of Health in 2009, clear specifications in the Regulation for Health Goods in 2011, and further requirements in the Mexican Official Norm NOM-EM-001-SSA1-2012. The aim of this review is to summarize the regulatory pathways for biosimilars in the world with a special focus on Mexican experience, so as contribute to the development of regulations in other countries. Copyright © 2013 Elsevier Inc. All rights reserved.

  13. Review of light water reactor regulatory requirements: Assessment of selected regulatory requirements that may have marginal importance to risk: Postaccident sampling system, Turbine missiles, Combustible gas control, Charcoal filters

    International Nuclear Information System (INIS)

    Scott, W.B.; Jamison, J.D.; Stoetzel, G.A.; Tabatabai, A.S.; Vo, T.V.

    1987-05-01

    In a study commissioned by the Nuclear Regulatory Commission (NRC), Pacific Northwest Laboratory (PNL) evaluated the costs and benefits of modifying regulatory requirements in the areas of the postaccident sampling system, turbine rotor design reviews and inspections, combustible gas control for inerted Boiling Water Reactor (BWR) containments, and impregnated charcoal filters in certain plant ventilation systems. The basic framework for the analyses was that presented in the Regulatory Analysis Guidelines (NUREG/BR-0058) and in the Handbook for Value-Impact Assessment (NUREG/CR-3568). The effects of selected modifications to regulations were evaluated in terms of such factors as public risk and costs to industry and NRC. The results indicate that potential modifications of the regulatory requirements in three of the four areas would have little impact on public risk. In the fourth area, impregnated charcoal filters in building ventilation systems do appear to limit risks to the public and plant staff. Revisions in the severe accident source term assumptions, however, may reduce the theoretical value of charcoal filters. The cost analysis indicated that substantial savings in operating costs may be realized by changing the interval of turbine rotor inspections. Small to moderate operating cost savings may be realized through postulated modifications to the postaccident sampling system requirements and to the requirements for combustible gas control in inerted BWR containments. Finally, the use of impregnated charcoal filters in ventilation systems appears to be the most cost-effective method of reducing radioiodine concentrations

  14. Regulatory Review Committee update

    Energy Technology Data Exchange (ETDEWEB)

    Steele, T. [Polishuk, Camman and Steele, London ON (Canada)

    2001-07-01

    The Committee's objectives, current membership and current issues are reviewed. Each current issue, notably the consultation process with the Ministry of Natural Resources, appeal of Ministry actions, orphan wells/security deposits, oilfield fluid disposal and labour code practices review are discussed in some detail. Dissatisfaction with the current appeals process to the Ministry is highlighted, along with a search for an all encompassing solution. The orphan well problem also received considerable attention, with similar demands for a comprehensive solution.

  15. Diagnostic performance of major depression disorder case-finding instruments used among mothers of young children in the United States: A systematic review.

    Science.gov (United States)

    Owora, Arthur H; Carabin, Hélène; Reese, Jessica; Garwe, Tabitha

    2016-09-01

    Growing recognition of the interrelated negative outcomes associated with major depression disorder (MDD) among mothers and their children has led to renewed public health interest in the early identification and treatment of maternal MDD. Healthcare providers, however, remain unsure of the validity of existing case-finding instruments. We conducted a systematic review to identify the most valid maternal MDD case-finding instrument used in the United States. We identified articles reporting the sensitivity and specificity of MDD case-finding instruments based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) by systematically searching through three electronic bibliographic databases, PubMed, PsycINFO, and EMBASE, from 1994 to 2014. Study eligibility and quality were evaluated using the Standards for the Reporting of Diagnostic Accuracy studies and Quality Assessment of Diagnostic Accuracy Studies guidelines respectively. Overall, we retrieved 996 unduplicated articles and selected 74 for full-text review. Of these, 14 articles examining 21 different instruments were included in the systematic review. The 10 item Edinburgh Postnatal Depression Scale and Postpartum Depression Screening Scale had the most stable (lowest variation) and highest diagnostic performance during the antepartum and postpartum periods (sensitivity range: 0.63-0.94 and 0.67-0.95; specificity range: 0.83-0.98 and 0.68-0.97 respectively). Greater variation in diagnostic performance was observed among studies with higher MDD prevalence. Factors that explain greater variation in instrument diagnostic performance in study populations with higher MDD prevalence were not examined. Findings suggest that the diagnostic performance of maternal MDD case-finding instruments is peripartum period-specific. Published by Elsevier B.V.

  16. The Effects of Degraded Digital Instrumentation and Control Systems on Human-system Interfaces and Operator Performance: HFE Review Guidance and Technical Basis

    International Nuclear Information System (INIS)

    O'Hara, J.M.; Gunther, W.; Martinez-Guridi, G.

    2010-01-01

    New and advanced reactors will use integrated digital instrumentation and control (I and C) systems to support operators in their monitoring and control functions. Even though digital systems are typically highly reliable, their potential for degradation or failure could significantly affect operator performance and, consequently, impact plant safety. The U.S. Nuclear Regulatory Commission (NRC) supported this research project to investigate the effects of degraded I and C systems on human performance and plant operations. The objective was to develop human factors engineering (HFE) review guidance addressing the detection and management of degraded digital I and C conditions by plant operators. We reviewed pertinent standards and guidelines, empirical studies, and plant operating experience. In addition, we conducted an evaluation of the potential effects of selected failure modes of the digital feedwater system on human-system interfaces (HSIs) and operator performance. The results indicated that I and C degradations are prevalent in plants employing digital systems and the overall effects on plant behavior can be significant, such as causing a reactor trip or causing equipment to operate unexpectedly. I and C degradations can impact the HSIs used by operators to monitor and control the plant. For example, sensor degradations can make displays difficult to interpret and can sometimes mislead operators by making it appear that a process disturbance has occurred. We used the information obtained as the technical basis upon which to develop HFE review guidance. The guidance addresses the treatment of degraded I and C conditions as part of the design process and the HSI features and functions that support operators to monitor I and C performance and manage I and C degradations when they occur. In addition, we identified topics for future research.

  17. Regulatory agencies and regulatory risk

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2008-01-01

    The aim of this paper is to show that regulatory risk is due to the discretionary behaviour of regulatory agencies, caused by a too extensive regulatory mandate provided by the legislator. The normative point of reference and a behavioural model of regulatory agencies based on the positive theory of regulation are presented. Regulatory risk with regard to the future behaviour of regulatory agencies is modelled as the consequence of the ex ante uncertainty about the relative influence of inter...

  18. Instrumentation

    International Nuclear Information System (INIS)

    Muehllehner, G.; Colsher, J.G.

    1982-01-01

    This chapter reviews the parameters which are important to positron-imaging instruments. It summarizes the options which various groups have explored in designing tomographs and the methods which have been developed to overcome some of the limitations inherent in the technique as well as in present instruments. The chapter is not presented as a defense of positron imaging versus single-photon or other imaging modality, neither does it contain a description of various existing instruments, but rather stresses their common properties and problems. Design parameters which are considered are resolution, sampling requirements, sensitivity, methods of eliminating scattered radiation, random coincidences and attenuation. The implementation of these parameters is considered, with special reference to sampling, choice of detector material, detector ring diameter and shielding and variations in point spread function. Quantitation problems discussed are normalization, and attenuation and random corrections. Present developments mentioned are noise reduction through time-of-flight-assisted tomography and signal to noise improvements through high intrinsic resolution. Extensive bibliography. (U.K.)

  19. Review: The Use of Real-Time Fluorescence Instrumentation to Monitor Ambient Primary Biological Aerosol Particles (PBAP

    Directory of Open Access Journals (Sweden)

    Mehael J. Fennelly

    2017-12-01

    Full Text Available Primary biological aerosol particles (PBAP encompass many particle types that are derived from several biological kingdoms. These aerosol particles can be composed of both whole living units such as pollen, bacteria, and fungi, as well as from mechanically formed particles, such as plant debris. They constitute a significant proportion of the overall atmospheric particle load and have been linked with adverse health issues and climatic effects on the environment. Traditional methods for their analysis have focused on the direct capture of PBAP before subsequent laboratory analysis. These analysis types have generally relied on direct optical microscopy or incubation on agar plates, followed by time-consuming microbiological investigation. In an effort to address some of these deficits, real-time fluorescence monitors have come to prominence in the analysis of PBAP. These instruments offer significant advantages over traditional methods, including the measurement of concentrations, as well as the potential to simultaneously identify individual analyte particles in real-time. Due to the automated nature of these measurements, large data sets can be collected and analyzed with relative ease. This review seeks to highlight and discuss the extensive literature pertaining to the most commonly used commercially available real-time fluorescence monitors (WIBS, UV-APS and BioScout. It discusses the instruments operating principles, their limitations and advantages, and the various environments in which they have been deployed. The review provides a detailed examination of the ambient fluorescent aerosol particle concentration profiles that are obtained by these studies, along with the various strategies adopted by researchers to analyze the substantial data sets the instruments generate. Finally, a brief reflection is presented on the role that future instrumentation may provide in revolutionizing this area of atmospheric research.

  20. Clinimetric properties of instruments to assess activities in patients with hand injury: a systematic review of the literature.

    NARCIS (Netherlands)

    Ven-Stevens, L.A.W. van de; Munneke, M.; Terwee, C.B.; Spauwen, P.H.M.; Linde, H. van der

    2009-01-01

    OBJECTIVE: To perform a systematic review of the literature to assess the clinimetric properties of instruments measuring limitations of activity. DATA SOURCES: The Medline, Cochrane Library, Picarta, Occupational Therapy-seeker, and CINAHL databases were searched for English or Dutch language

  1. Development of Risk Insights for Regulatory Review of a Near-Surface Disposal Facility for Radioactive Waste

    International Nuclear Information System (INIS)

    Esh, D.W.; Ridge, A.C.; Thaggard, M.

    2006-01-01

    Section 3116 of the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005 (NDAA) requires the Department of Energy (DOE) to consult with the Nuclear Regulatory Commission (NRC) about non-High Level Waste (HLW) determinations. In its consultative role, NRC performs technical reviews of DOE's waste determinations but does not have regulatory authority over DOE's waste disposal activities. The safety of disposal is evaluated by comparing predicted disposal facility performance to the performance objectives specified in NRC regulations for the disposal of low-level waste (10 CFR Part 61 Subpart C). The performance objectives contain criteria for protection of the public, protection of inadvertent intruders, protection of workers, and stability of the disposal site after closure. The potential radiological dose to receptors typically is evaluated with a performance assessment (PA) model that simulates the release of radionuclides from the disposal site, transport of radionuclides through the environment, and exposure of potential receptors to residual contamination for thousands of years. This paper describes NRC's development and use of independent performance assessment modeling to facilitate review of DOE's non-HLW determination for the Saltstone Disposal Facility (SDF) at the Savannah River Site. NRC's review of the safety of near-surface disposal of radioactive waste at the SDF was facilitated and focused by risk insights developed with an independent PA model. The main components of NRC's performance assessment model are presented. The development of risk insights that allow the staff to focus review efforts on those areas that are most important to satisfying the performance objectives is discussed. Uncertainty analysis was performed of the full stochastic model using genetic variable selection algorithms. The results of the uncertainty analysis were then used to guide the development of simulations of other scenarios to understand the key risk

  2. A regulatory review for products containing glutathione

    Directory of Open Access Journals (Sweden)

    Nur Hidayah Abd Rahim

    2016-01-01

    Full Text Available Glutathione is a potent antioxidant as well as has important role for DNA synthesis and repair, protein synthesis, amino acid transport, and enzyme activation. Besides this, Glutathione products are now mainly selling as whitening agent which are mainly marketing through social media (Facebook and different websites. Information is not available whether glutathione product are following the regulatory guidelines of National Pharmaceutical Control Bureau of Malaysia (NPCB for selling, advertisement and promotion. This review was carried out by extracting information about glutathione from scientific database using PubMed, Cochrane Library and Embase. Analysis of the available information, case example of glutathione products showed that a brand of glutathione (Glutacaps HQ did not show the product's registration number from NPCB, and also did not show the name, address, contact number of the advertiser, and even not found the name of the manufacture. Without providing the above mentioned information, the product is selling and promoting through social media (fb which is not allowed by the NPCB guidelines part 4.14. So far, only two clinical trials were conducted on glutathione supplementation for 4 weeks duration. There was no serious or systematic adverse effects reported in clinical trials. As the two clinic trials resulted contradictory outcomes, further studies needed for conformation of the clinic benefits of glutathione. Otherwise, random use of glutathione may be risk for the health of the people. Besides, the marketer mainly promoting glutathione as the skin whitening beauty product instead of using as health supplement, it may cause additional and serious risk to the users as the manufacturer not providing sufficient information about the product, its registration number, manufacturing company, etc.

  3. Mild cognitive impairment and deficits in instrumental activities of daily living: a systematic review.

    Science.gov (United States)

    Jekel, Katrin; Damian, Marinella; Wattmo, Carina; Hausner, Lucrezia; Bullock, Roger; Connelly, Peter J; Dubois, Bruno; Eriksdotter, Maria; Ewers, Michael; Graessel, Elmar; Kramberger, Milica G; Law, Emma; Mecocci, Patrizia; Molinuevo, José L; Nygård, Louise; Olde-Rikkert, Marcel Gm; Orgogozo, Jean-Marc; Pasquier, Florence; Peres, Karine; Salmon, Eric; Sikkes, Sietske Am; Sobow, Tomasz; Spiegel, René; Tsolaki, Magda; Winblad, Bengt; Frölich, Lutz

    2015-01-01

    There is a growing body of evidence that subtle deficits in instrumental activities of daily living (IADL) may be present in mild cognitive impairment (MCI). However, it is not clear if there are IADL domains that are consistently affected across patients with MCI. In this systematic review, therefore, we aimed to summarize research results regarding the performance of MCI patients in specific IADL (sub)domains compared with persons who are cognitively normal and/or patients with dementia. The databases PsycINFO, PubMed and Web of Science were searched for relevant literature in December 2013. Publications from 1999 onward were considered for inclusion. Altogether, 497 articles were retrieved. Reference lists of selected articles were searched for potentially relevant articles. After screening the abstracts of these 497 articles, 37 articles were included in this review. In 35 studies, IADL deficits (such as problems with medication intake, telephone use, keeping appointments, finding things at home and using everyday technology) were documented in patients with MCI. Financial capacity in patients with MCI was affected in the majority of studies. Effect sizes for group differences between patients with MCI and healthy controls were predominantly moderate to large. Performance-based instruments showed slight advantages (in terms of effect sizes) in detecting group differences in IADL functioning between patients with MCI, patients with Alzheimer's disease and healthy controls. IADL requiring higher neuropsychological functioning seem to be most severely affected in patients with MCI. A reliable identification of such deficits is necessary, as patients with MCI with IADL deficits seem to have a higher risk of converting to dementia than patients with MCI without IADL deficits. The use of assessment tools specifically designed and validated for patients with MCI is therefore strongly recommended. Furthermore, the development of performance-based assessment instruments

  4. Review and evaluation of the Nuclear Regulatory Commission safety research program for Fiscal Year 1983. Report to the Congress

    International Nuclear Information System (INIS)

    1982-02-01

    Public Law 95-209 includes a requirement that the Advisory Committee on Reactor Safeguards submit an annual report to Congress on the safety research program of the Nuclear Regulatory Commission. This report presents the results of the ACRS review and evaluation of the NRC safety research program for Fiscal Year 1983. The report contains a number of comments and recommendations

  5. Regulatory analysis technical evaluation handbook. Final report

    International Nuclear Information System (INIS)

    1997-01-01

    The purpose of this Handbook is to provide guidance to the regulatory analyst to promote preparation of quality regulatory analysis documents and to implement the policies of the Regulatory Analysis Guidelines of the US Nuclear Regulatory Commission (NUREG/BR-0058 Rev. 2). This Handbook expands upon policy concepts included in the NRC Guidelines and translates the six steps in preparing regulatory analyses into implementable methodologies for the analyst. It provides standardized methods of preparation and presentation of regulatory analyses, with the inclusion of input that will satisfy all backfit requirements and requirements of NRC's Committee to Review Generic Requirements. Information on the objectives of the safety goal evaluation process and potential data sources for preparing a safety goal evaluation is also included. Consistent application of the methods provided here will result in more directly comparable analyses, thus aiding decision-makers in evaluating and comparing various regulatory actions. The handbook is being issued in loose-leaf format to facilitate revisions. NRC intends to periodically revise the handbook as new and improved guidance, data, and methods become available

  6. Regulatory requirements related to maintenance and compliance monitoring

    International Nuclear Information System (INIS)

    Ling, A.K.H.

    1997-01-01

    The maintenance related regulatory requirements are identified in the regulatory documents and licence conditions. Licensee complies with these requirements by operating the nuclear power plant within the safe operating envelope as given in the operating policies and principles and do maintenance according to approved procedures and/or work plans. Safety systems are regularly tested. AECB project officers review and check to ensure that the licensee operates the nuclear power plant in accordance with the regulatory requirements and licence conditions. (author). 6 tabs

  7. Biodiversity conservation and climate mitigation: What role can economic instruments play?

    NARCIS (Netherlands)

    Ring, I.; Drechsler, M.; Teeffelen, van A.J.A.; Irawan, S.; Venter, O.

    2010-01-01

    Tradable permits and intergovernmental fiscal transfers play an increasing role in both biodiversity conservation and climate mitigation. In comparison to regulatory and planning approaches these economic instruments offer a more flexible and cost-effective approach to biodiversity conservation.

  8. Instrument choice when regulators are concerned about resource extinction

    DEFF Research Database (Denmark)

    Hansen, Lars Gårn; Jensen, Frank; Russell, Clifford

    In this paper we undertake a systematic investigation of instrument choice when preventing a population collapse rather than maximizing industry profit is the overriding concern. Contrary to what seems to be the general consensus we find that landing fees do provide more effective insurance against...... extinction than quotas under more or less the same conditions as those implying that landing fees are better at maximising industry profit. Thus, the efficiency of the regulatory instrument mainly depends on the basic information asymmetries characterizing the fishery, and is not sensitive to whether...

  9. Psychosocial measures used to assess the effectiveness of school-based nutrition education programs: review and analysis of self-report instruments for children 8 to 12 years old.

    Science.gov (United States)

    Hernández-Garbanzo, Yenory; Brosh, Joanne; Serrano, Elena L; Cason, Katherine L; Bhattarai, Ranju

    2013-01-01

    To identify the psychometric properties of evaluation instruments that measure mediators of dietary behaviors in school-aged children. Systematic search of scientific databases limited to 1999-2010. Psychometric properties related to development and testing of self-report instruments for children 8-12 years old. Systematic search of 189 articles and review of 15 instruments (20 associated articles) meeting the inclusion criteria. Search terms used included children, school, nutrition, diet, nutrition education, and evaluation. Fourteen studies used a theoretical framework to guide the instrument's development. Knowledge and self-efficacy were the most commonly used psychosocial measures. Twelve instruments focused on specific nutrition-related behaviors. Eight instruments included over 40 items and used age-appropriate response formats. Acceptable reliability properties were most commonly reported for attitude and self-efficacy measures. Although most of the instruments were reviewed by experts (n = 8) and/or pilot-tested (n = 9), only 7 were tested using both rigorous types of validity and with low-income youth. Results from this review suggest that additional research is needed to develop more robust psychosocial measures for dietary behaviors, for low-income youth audiences. Copyright © 2013 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

  10. Survey of regulatory agency review of generating unit performance

    International Nuclear Information System (INIS)

    Roach, E.M. Jr.; Tarletz, D.B.

    1985-01-01

    Regulatory agencies across the country are being called upon increasingly to monitor the management of electric utilities. Such activity, which once was relatively rare, is now common. Most frequently this oversight centers around the operating performance of generating units, both nuclear and fossil. There are, perhaps, several reasons for this increased interest in the efficient operation of generating units: increased fuel costs and fuel cost differentials, increased lead times and costs for construction of new generating units, and increased dependence on existing units because of construction programs being revised to meet decreased load growth. The monitoring of generating units has taken the form of after the fact evaluation of performance on a case-by-case basis and the implementation of productivity incentive programs. Performance standards are used in these contexts both to measure the adequacy of unit performance and to implement incentives in the form of rewards or penalties. The standard used may be a subjective test of prudent performance or some numerical index of plant performance, e.g., equivalent availability, capacity factor or heat rate. Some of the activity by regulators is reviewed in applying subjective and numerical standards and the considerations involved in applying such standards are discussed

  11. Nuclear regulatory review of licensee self-assessment (LSA)

    International Nuclear Information System (INIS)

    2003-01-01

    Licensee self-assessment (LSA) by nuclear power plant operators is described as all the activities that a licensee performs in order to identify opportunities for improvements. An LSA is part of an organisation's holistic management system, which must include other process elements. Particularly important elements are: a process for choosing which identified potential improvements should be implemented and a process of project management for implementing the improvements chosen. Nuclear regulators expect the licensee to run an effective LSA programme, which reflects the licensee's 'priority to safety'. Based on contributions from members of the NEA Committee on Nuclear Regulatory Activities (CNRA), this publication provides an overview of the current regulatory philosophy on and approaches to LSA as performed by licensees. The publication's intended audience is primarily nuclear safety regulators, but government authorities, nuclear power plant operators and the general public may also be interested. (author)

  12. Development of human factors design review guidelines

    International Nuclear Information System (INIS)

    Lee, Jung Woon; Oh, In Suk; Suh, Sang Moon; Lee, Hyun Chul

    1997-10-01

    The Objective of this study is to develop human factors engineering program review guidelines and alarm system review guidelines in order to resolve the two major technical issues: '25, Human factors engineering program review model' and '26, Review criteria for human actors aspects of advanced controls and instrumentation', which are related to the development of human factors safety regulation guides be ing performed by KINS. For the development of human factors program review guidelines, we made a Korean version of NUREG-0711 and added our comments by considering Korean regulatory situation and reviewing the reference documents of NUREG-0711. We also computerized the Korean version of NUREG-0711, additional comments, and selected portion of the reference documents for the developer of safety regulation guides in KINS to see the contents comparatively at a glance and use them easily. For the development of alarm system review guidelines, we made a Korean version of NUREG/CR-6105, which was published by NRC in 1994 as a guideline document for the human factors review of alarm systems. Then we well update the guidelines by reviewing the literature related to alarm design published after 1994

  13. Development of human factors design review guidelines

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jung Woon; Oh, In Suk; Suh, Sang Moon; Lee, Hyun Chul [Korea Atomic Energy Research Institute, Taejon (Korea)

    1997-10-01

    The objective of this study is to develop human factors engineering program review guidelines and alarm system review guidelines in order to resolve the two major technical issues: 25. Human Factors Engineering Program Review Model and 26. Review Criteria for Human Factors Aspects of Advanced Controls and Instrumentation, which are related to the development of human factors safety regulation guides being performed by KINS. For the development of human factors program review guidelines, we made a Korean version of NUREG-0711 and added our comments by considering Korean regulatory situation and reviewing the reference documents of NUREG-0711. We also computerized the Korean version of NUREG-0711, additional comments, and selected portion of the reference documents for the developer of safety regulation guides in KINS to see the contents comparatively at a glance and use them easily. For the development of alarm system review guidelines, we made a Korean version of NUREG/CR-6105, which was published by NRC in 1994 as a guideline document for the human factors review of alarm systems. Then we will update the guidelines by reviewing the literature related to alarm design published after 1994. (author). 12 refs., 5 figs., 2 tabs.

  14. Codes and standards and other guidance cited in regulatory documents. Revision 1

    International Nuclear Information System (INIS)

    Ankrum, A.; Nickolaus, J.; Vinther, R.; Maguire-Moffitt, N.; Hammer, J.; Sherfey, L.; Warner, R.

    1994-08-01

    As part of the US Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program, Pacific Northwest Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. In addition to updating previous information, Revision 1 adds citations from the NRC Inspection Manual and the Improved Standard Technical Specifications. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC's Bulletins, Information Notices, Circulars, Generic Letters, Policy Statements, Regulatory Guides, and the Standard Review Plan (NUREG-0800)

  15. Codes and standards and other guidance cited in regulatory documents. Revision 1

    Energy Technology Data Exchange (ETDEWEB)

    Ankrum, A.; Nickolaus, J.; Vinther, R.; Maguire-Moffitt, N.; Hammer, J.; Sherfey, L.; Warner, R. [Pacific Northwest Lab., Richland, WA (United States)

    1994-08-01

    As part of the US Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program, Pacific Northwest Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. In addition to updating previous information, Revision 1 adds citations from the NRC Inspection Manual and the Improved Standard Technical Specifications. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC`s Bulletins, Information Notices, Circulars, Generic Letters, Policy Statements, Regulatory Guides, and the Standard Review Plan (NUREG-0800).

  16. Regulatory system reform of occupational health and safety in China.

    Science.gov (United States)

    Wu, Fenghong; Chi, Yan

    2015-01-01

    With the explosive economic growth and social development, China's regulatory system of occupational health and safety now faces more and more challenges. This article reviews the history of regulatory system of occupational health and safety in China, as well as the current reform of this regulatory system in the country. Comprehensive, a range of laws, regulations and standards that promulgated by Chinese government, duties and responsibilities of the regulatory departments are described. Problems of current regulatory system, the ongoing adjustments and changes for modifying and improving regulatory system are discussed. The aim of reform and the incentives to drive forward more health and safety conditions in workplaces are also outlined.

  17. Assessing EU’s Transatlantic Regulatory Powers Using the Choice of Policy Instruments as Measurement of Preference Attainment

    DEFF Research Database (Denmark)

    Löfgren, Karl; Lynggaard, Kennet

    2015-01-01

    concern are the implications of the still present financial and economic crisis for global regulatory power. Both cases suggest that the actual role of the EU is more complex than either exercising or subject to global regulatory power. This concerns the relationship between the EU and the member states...

  18. Franchise Values, Regulatory Monitoring, and Capital Requirements in Optimal Bank Regulation

    DEFF Research Database (Denmark)

    Andersen, Thomas Barnebeck; Harr, Thomas

    2008-01-01

    This paper demonstrates that financial deregulation is likely to make standard prudential regulatory instruments less effective in curbing excessive risk-taking incentives among banks. This has interesting implications for optimal bank regulation. When there is an increase in competition, the opt...

  19. Regulatory issues in the maintenance of Argentine nuclear power plants

    International Nuclear Information System (INIS)

    Castro, E.; Caruso, G.

    1997-01-01

    The influence of maintenance activities upon nuclear safety and their relevance as means to detect and prevent aging make them play an outstanding role among the fields of interest of the Argentine nuclear regulatory body (ENREN). Such interest is reinforced by the fact that the data obtained during maintenance are used - among other - as inputs in the Probabilistic Safety Analyses required for those nuclear power plants. This paper provides a brief description of the original requirements by the regulatory body concerning maintenance, of the factors that led to review the criteria involved in such requirements and of the key items identified during the reviewing process. The latter shall be taken into account in the maintenance regulatory policy, for the consequent issue of new requirements from the utilities and for the eventual publication of a specific regulatory standard. (author)

  20. Cross-cultural feigning assessment: A systematic review of feigning instruments used with linguistically, ethnically, and culturally diverse samples.

    Science.gov (United States)

    Nijdam-Jones, Alicia; Rosenfeld, Barry

    2017-11-01

    The cross-cultural validity of feigning instruments and cut-scores is a critical concern for forensic mental health clinicians. This systematic review evaluated feigning classification accuracy and effect sizes across instruments and languages by summarizing 45 published peer-reviewed articles and unpublished doctoral dissertations conducted in Europe, Asia, and North America using linguistically, ethnically, and culturally diverse samples. The most common psychiatric symptom measures used with linguistically, ethnically, and culturally diverse samples included the Structured Inventory of Malingered Symptomatology, the Miller Forensic Assessment of Symptoms Test, and the Minnesota Multiphasic Personality Inventory (MMPI). The most frequently studied cognitive effort measures included the Word Recognition Test, the Test of Memory Malingering, and the Rey 15-item Memory test. The classification accuracy of these measures is compared and the implications of this research literature are discussed. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  1. Cost-benefit considerations in regulatory decision-making

    International Nuclear Information System (INIS)

    Harvie, J.D.

    1996-01-01

    The Atomic Energy Control Board is investigating the feasibility of developing methods for factoring cost-benefit considerations into its regulatory decision-making. This initiative results, in part, from the federal government policy requiring cost-benefit considerations to be taken into account in regulatory processes, and from the recommendations of an Advisory Panel on Regulatory Review in 1993, submitted to the Minister of Natural Resources Canada. One of these recommendations stated: 'that mechanisms be developed to examine cost-benefit issues and work towards some consensus of opinion among stakeholders; a task force on the subject could be an appropriate starting point'. (author)

  2. Neutron instrumentation for biology

    Energy Technology Data Exchange (ETDEWEB)

    Mason, S.A. [Institut Laue-Langevin, Grenoble (France)

    1994-12-31

    In the October 1994 round of proposals at the ILL, the external biology review sub- committee was asked to allocate neutron beam time to a wide range of experiments, on almost half the total number of scheduled neutron instruments: on 3 diffractometers, on 3 small angle scattering instruments, and on some 6 inelastic scattering spectrometers. In the 3.5 years since the temporary reactor shutdown, the ILL`s management structure has been optimized, budgets and staff have been trimmed, the ILL reactor has been re-built, and many of the instruments up-graded, many powerful (mainly Unix) workstations have been introduced, and the neighboring European Synchrotron Radiation Facility has established itself as the leading synchrotron radiation source and has started its official user program. The ILL reactor remains the world`s most intense dedicated neutron source. In this challenging context, it is of interest to review briefly the park of ILL instruments used to study the structure and energetics of small and large biological systems. A brief summary will be made of each class of experiments actually proposed in the latest ILL proposal round.

  3. Economic instruments for population diet and physical activity behaviour change: a systematic scoping review.

    Directory of Open Access Journals (Sweden)

    Ian Shemilt

    Full Text Available Unhealthy diet and low levels of physical activity are common behavioural factors in the aetiology of many non-communicable diseases. Recent years have witnessed an upsurge of policy and research interest in the use of taxes and other economic instruments to improve population health.To assemble, configure and analyse empirical research studies available to inform the public health case for using economic instruments to promote dietary and physical activity behaviour change.We conducted a systematic scoping review of evidence for the effects of specific interventions to change, or general exposure to variations in, prices or income on dietary and physical activity behaviours and corollary outcomes. Systematic electronic searches and parallel snowball searches retrieved >1 million study records. Text mining technologies were used to prioritise title-abstract records for screening. Eligible studies were selected, classified and analysed in terms of key characteristics and principal findings, using a narrative, configuring synthesis focused on implications for policy and further research.We identified 880 eligible studies, including 192 intervention studies and 768 studies that incorporated evidence for prices or income as correlates or determinants of target outcomes. Current evidence for the effects of economic instruments and exposures on diet and physical activity is limited in quality and equivocal in terms of its policy implications. Direct evidence for the effects of economic instruments is heavily skewed towards impacts on diet, with a relative lack of evidence for impacts on physical activity.The evidence-based case for using economic instruments to promote dietary and physical activity behaviour change may be less compelling than some proponents have claimed. Future research should include measurement of people's actual behavioural responses using study designs capable of generating reliable causal inferences regarding intervention

  4. Regulatory aspects of radiation protection in Indian nuclear plants

    International Nuclear Information System (INIS)

    Chander, Vipin; Pawar, S.K.; Duraisamy, S.

    2012-01-01

    Atomic Energy Act of 1962 covers the radiation safety aspects in the development, control and use of atomic energy. To carry out certain regulatory and safety functions under this act, Atomic Energy Regulatory Board (AERB) was constituted in November 15, 1983. Operating Nuclear Power Plants (NPPs) account for about 60% of occupational collective dose and about 65% of the number of radiation workers in the nuclear fuel cycle facilities. Therefore radiation protection aspects in NPPs are of prime importance. In 1970s and 1980s the high radiation exposures in NPPs was an issue with TAPS-1 and 2 reaching annual collective dose of 50 Person-Sv. In response to this, AERB constituted an expert committee to investigate the possibility of reducing collective doses in NPPs in 1988. Subsequently the recommendations of this committee were implemented in all NPPs. In 1990, International Commission on Radiological Protection (ICRP) recommended a downward revision of occupational dose limit to 20 mSv/yr from the earlier limit of 50 mSv/yr. Regulatory body endorsed these recommendations and gradually brought down the annual dose limits from 40 mSv in 1991 to 30 mSv in 1994 with the limit of 100 mSv averaged over a five year period in line with ICRP recommendations. Over the years, the regulatory body has put in place a sound regulatory frame work and mechanism to ensure adequate protection of occupational workers, members of public and environment due to operation of NPPs. Vast experiences in the field of radiation protection vis-à-vis stringent regulatory requirements such as review of exposure cases and special regulatory inspections during Biennial Shut Down (BSD) has helped in downward trends in occupational and public doses. This paper highlights the role of regulatory body in controlling the radiation doses to both occupational workers and members of public in the NPPs through a three-tier review system. The regulatory oversight, inspections and reviews has resulted in

  5. Governing towards renewable energy in the EU: competences, instruments and procedures

    NARCIS (Netherlands)

    Peeters, M.G.W.M.

    2014-01-01

    ABSTRACT Th is contribution maps new questions and explores potential problems in EU renewable energy law, focusing on competences, regulatory instruments and administrative procedures. The transition towards renewable energy concerns a major transformation of society, which cannot be done on a

  6. Patient-Reported Outcome Measures in Dysphagia: A Systematic Review of Instrument Development and Validation

    Science.gov (United States)

    Patel, Dhyanesh A.; Sharda, Rohit; Hovis, Kristen L.; Nichols, Erin E.; Sathe, Nila; Penson, David F.; Feurer, Irene D.; McPheeters, Melissa L.; Vaezi, Michael F.; Francis, David O.

    2017-01-01

    Objective Patient-reported outcome (PRO) measures are commonly used to capture patient experience with dysphagia and to evaluate treatment effectiveness. Inappropriate application can lead to distorted results in clinical studies. A systematic review of the literature on dysphagia-related PRO measures was performed to 1) identify all currently available measures and 2) to evaluate each for the presence of important measurement properties that would affect their applicability. Design MEDLINE via the PubMed interface, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument database were searched using relevant vocabulary terms and key terms related to PRO measures and dysphagia. Three independent investigators performed abstract and full text reviews. Each study meeting criteria was evaluated using an 18-item checklist developed a priori that assessed multiple domains: 1) conceptual model, 2) content validity, 3) reliability, 4) construct validity, 6) scoring and interpretation, and 7) burden and presentation. Results Of 4950 abstracts reviewed, a total of 34 dysphagia-related PRO measures (publication year 1987 – 2014) met criteria for extraction and analysis. Several PRO measures were of high quality (MADS for achalasia, SWAL-QOL and SSQ for oropharyngeal dysphagia, PROMIS-GI for general dysphagia, EORTC-QLQ-OG25 for esophageal cancer, ROMP-swallowing for Parkinson’s disease, DSQ-EoE for eosinophilic esophagitis, and SOAL for total laryngectomy-related dysphagia). In all, 17 met at least one criterion per domain. Thematic deficiencies in current measures were evident including: 1) direct patient involvement in content development, 2) empirically justified dimensionality, 3) demonstrable responsiveness to change, 4) plan for interpreting missing responses, and 5) literacy level assessment. Conclusion This is the first comprehensive systematic review assessing developmental properties of all available dysphagia

  7. VALIDATION OF ANALYTICAL METHODS AND INSTRUMENTATION FOR BERYLLIUM MEASUREMENT: REVIEW AND SUMMARY OF AVAILABLE GUIDES, PROCEDURES, AND PROTOCOLS

    Energy Technology Data Exchange (ETDEWEB)

    Ekechukwu, A.

    2008-12-17

    This document proposes to provide a listing of available sources which can be used to validate analytical methods and/or instrumentation for beryllium determination. A literature review was conducted of available standard methods and publications used for method validation and/or quality control. A comprehensive listing of the articles, papers, and books reviewed is given in Appendix 1. Available validation documents and guides are listed in the appendix; each has a brief description of application and use. In the referenced sources, there are varying approaches to validation and varying descriptions of validation at different stages in method development. This discussion focuses on validation and verification of fully developed methods and instrumentation that have been offered up for use or approval by other laboratories or official consensus bodies such as ASTM International, the International Standards Organization (ISO) and the Association of Official Analytical Chemists (AOAC). This review was conducted as part of a collaborative effort to investigate and improve the state of validation for measuring beryllium in the workplace and the environment. Documents and publications from the United States and Europe are included. Unless otherwise specified, all documents were published in English.

  8. Outlines and Outcomes of Instrumented Posterior Fusion in the Pediatric Cervical Spine: A Review Article

    Directory of Open Access Journals (Sweden)

    Kaveh Haddadi

    2016-01-01

    Full Text Available Context The most common source of cervical spine arthrodesis in the pediatric populace is the instability related to congenital or traumatic damage. Surgery of cervical spine can be challenging given slighter anatomical constructions, fewer hardened bone, and upcoming growth potential and growth. Evidence Acquisition Trainings in adult patients recommended that consuming screw constructs results in enhanced consequences with inferior amounts of instrumentation catastrophe. But, the pediatric literature is inadequate for minor retrospective series. Authors reviewed the existing pediatric cervical spine arthrodesis literature. They studied 184 abstracts from January 1976 to December 2014. An entire of 883 patients in 82 articles were involved in the evaluation. Patients were characterized as taking either posterior cervical fusion with wiring or posterior cervical fusion with screws or occipitocervical fusion. Results The etiologies faced most frequently were inherited abnormalities (54% shadowed by trauma (28%, Down syndrome (8%, and infectious, oncological, iatrogenic, or mixed causes (10%. The mean duration of follow-up was 32.5 months. Conclusions The consequences of this training are restricted by deviations in construct policy, usage of orthoses, follow-up period and fresher adjuvant produces stimulating fusions. But, a literature review recommend that instrumentation of the cervical spine in children may be harmless and more effective than using screw concepts rather than wiring methods.

  9. The use of fiscal instruments in European environmental policy: review essay

    Energy Technology Data Exchange (ETDEWEB)

    Deketelaere, K. [University of Leuven, Leuven (Belgium). Inst. for Environmental and Energy Law

    1999-08-01

    Once a government has defined its environmental goals, it can execute them by means of different policy instruments. The following environmental policy instruments can be distinguished: (1) instruments of social regulation, such as transfer of information (environmental education, environmental labels, environmental impact reports, etc.), self-regulation (environmental policy agreements, self-control), and environmental care systems; (2) instruments of financial aid, such as subsidies, soft loans, and fiscal incentives (investment deduction, tax reduction and tax exemption); (3) instruments of planning such as macro-planning and micro-planning, binding planning and non-binding planning, sectoral planning and non-sectoral planning; (4) instruments of direct regulation, such as permits, prohibitions and restrictions, and different sorts of requirements (quality-demands, product-demands, emission-demands, design demands, construction demands and production demands); (5) instruments of market regulation, such as liability rules, marketable emission rights, deposit and refund system, enforcement incentives and environmental levies. In this contribution, each of these environmental policy instruments is analyzed in general. After that, the instruments which have already been used in European environmental policy are examined. Finally, attention paid to the use of fiscal instruments in European environmental policy. 80 refs.

  10. Analytical techniques for wine analysis: An African perspective; a review

    International Nuclear Information System (INIS)

    Villiers, André de; Alberts, Phillipus; Tredoux, Andreas G.J.; Nieuwoudt, Hélène H.

    2012-01-01

    Highlights: ► Analytical techniques developed for grape and wine analysis in Africa are reviewed. ► The utility of infrared spectroscopic methods is demonstrated. ► An overview of separation of wine constituents by GC, HPLC, CE is presented. ► Novel LC and GC sample preparation methods for LC and GC are presented. ► Emerging methods for grape and wine analysis in Africa are discussed. - Abstract: Analytical chemistry is playing an ever-increasingly important role in the global wine industry. Chemical analysis of wine is essential in ensuring product safety and conformity to regulatory laws governing the international market, as well as understanding the fundamental aspects of grape and wine production to improve manufacturing processes. Within this field, advanced instrumental analysis methods have been exploited more extensively in recent years. Important advances in instrumental analytical techniques have also found application in the wine industry. This review aims to highlight the most important developments in the field of instrumental wine and grape analysis in the African context. The focus of this overview is specifically on the application of advanced instrumental techniques, including spectroscopic and chromatographic methods. Recent developments in wine and grape analysis and their application in the African context are highlighted, and future trends are discussed in terms of their potential contribution to the industry.

  11. Analytical techniques for wine analysis: An African perspective; a review

    Energy Technology Data Exchange (ETDEWEB)

    Villiers, Andre de, E-mail: ajdevill@sun.ac.za [Department of Chemistry and Polymer Science, Stellenbosch University, Private Bag X1, Matieland 7602, Stellenbosch (South Africa); Alberts, Phillipus [Department of Chemistry and Polymer Science, Stellenbosch University, Private Bag X1, Matieland 7602, Stellenbosch (South Africa); Tredoux, Andreas G.J.; Nieuwoudt, Helene H. [Institute for Wine Biotechnology, Department of Viticulture and Oenology, Stellenbosch University, Private Bag X1, Matieland 7602, Stellenbosch (South Africa)

    2012-06-12

    Highlights: Black-Right-Pointing-Pointer Analytical techniques developed for grape and wine analysis in Africa are reviewed. Black-Right-Pointing-Pointer The utility of infrared spectroscopic methods is demonstrated. Black-Right-Pointing-Pointer An overview of separation of wine constituents by GC, HPLC, CE is presented. Black-Right-Pointing-Pointer Novel LC and GC sample preparation methods for LC and GC are presented. Black-Right-Pointing-Pointer Emerging methods for grape and wine analysis in Africa are discussed. - Abstract: Analytical chemistry is playing an ever-increasingly important role in the global wine industry. Chemical analysis of wine is essential in ensuring product safety and conformity to regulatory laws governing the international market, as well as understanding the fundamental aspects of grape and wine production to improve manufacturing processes. Within this field, advanced instrumental analysis methods have been exploited more extensively in recent years. Important advances in instrumental analytical techniques have also found application in the wine industry. This review aims to highlight the most important developments in the field of instrumental wine and grape analysis in the African context. The focus of this overview is specifically on the application of advanced instrumental techniques, including spectroscopic and chromatographic methods. Recent developments in wine and grape analysis and their application in the African context are highlighted, and future trends are discussed in terms of their potential contribution to the industry.

  12. Review of NRC Commission Papers on Regulatory Basis for Licensing and Regulating Reprocessing Facilities

    Energy Technology Data Exchange (ETDEWEB)

    Park, Jae Yeong; Shin, Hyeong Ki [KINS, Daejeon (Korea, Republic of)

    2016-05-15

    Spent nuclear fuel (SNF) accumulated in nuclear power plant has been a serious issue in most countries with operating nuclear power plants. Direct disposal of SNF could be a solution of the problem but many countries including the Republic of Korea have had a hard time selecting a site for high level waste repository because of low public acceptance. SNF recycling technologies consisting of reprocessing and transmutation have been developed so as to reduce the final volume of the disposed radioactive waste and to diminish the radiotoxicity of the waste. The Republic of Korea is now developing pyroprocessing and sodium-cooled fast reactor (SFR) technology to be used for the recycling of the wastes. KAERI has a plan to construct a pyroprocessing facility with a capacity of 30 tHM/y and a facility manufacturing TRU fuel for SFR by 2025. However, to license these facility and secure the safety, the current regulatory system related to SNF treatment needs to be improved and amended since the system has been developed focusing on facilities to examine irradiated nuclear materials. Status of reprocessing facility regulations developed by U.S.NRC was reviewed based on SECY papers. U.S.NRC has approved the development of a new rule referred to nationally as '10CFR Part 7x'. Existing 10CFR 50 and 70 has been evolved mainly for nuclear power plants and fuel cycle facilities whose radiological hazard is much lower than reprocessing plants respectively. U.S.NRC also derived many regulatory gaps including safety assessment methods, technical specification, general design criteria and waste classification and continue to develop the regulatory framework limited in scope to the resolution of Gap 5.

  13. Systematic Assessment of Regulatory Competences (SARCON) V18a

    International Nuclear Information System (INIS)

    Zimmermann, Moritz

    2014-01-01

    Why Competence Management? • Arrangements for competence management is a key factor to: • Support the implementation of article 8 of CNS (Convention on Nuclear Safety – “regulatory body with adequate competence and human resources”); • Support the implementation of Modules 3 and 4 of the IRRS and other IAEA Safety Standards (Module 3: “Responsibilities and functions of the regulatory body”, Module 4: “Management system of the regulatory body”); • Identify gaps between regulatory required competences and the existing resources; • Develop and implement tools and programmes to fill the gaps; • Review periodically the competence needs and training programmes

  14. Reviews in Modern Astronomy 12, Astronomical Instruments and Methods at the turn of the 21st Century

    Science.gov (United States)

    Schielicke, Reinhard E.

    The yearbook series Reviews in Modern Astronomy of the Astronomische Gesellschaft (AG) was established in 1988 in order to bring the scientific events of the meetings of the society to the attention of the worldwide astronomical community. Reviews in Modern Astronomy is devoted exclusively to the invited Reviews, the Karl Schwarzschild Lectures, the Ludwig Biermann Award Lectures, and the highlight contributions from leading scientists reporting on recent progress and scientific achievements at their respective research institutes. Volume 12 continues the yearbook series with 16 contributions which were presented during the International Scientific Conference of the AG on ``Astronomical Instruments and Methods at the Turn of the 21st Century'' at Heidelberg from September 14 to 19, 1998

  15. Regulatory system reform of occupational health and safety in China

    Science.gov (United States)

    WU, Fenghong; CHI, Yan

    2015-01-01

    With the explosive economic growth and social development, China’s regulatory system of occupational health and safety now faces more and more challenges. This article reviews the history of regulatory system of occupational health and safety in China, as well as the current reform of this regulatory system in the country. Comprehensive, a range of laws, regulations and standards that promulgated by Chinese government, duties and responsibilities of the regulatory departments are described. Problems of current regulatory system, the ongoing adjustments and changes for modifying and improving regulatory system are discussed. The aim of reform and the incentives to drive forward more health and safety conditions in workplaces are also outlined. PMID:25843565

  16. Validity and reliability of instruments aimed at measuring Evidence-Based Practice in Physical Therapy: a systematic review of the literature.

    Science.gov (United States)

    Fernández-Domínguez, Juan Carlos; Sesé-Abad, Albert; Morales-Asencio, Jose Miguel; Oliva-Pascual-Vaca, Angel; Salinas-Bueno, Iosune; de Pedro-Gómez, Joan Ernest

    2014-12-01

    Our goal is to compile and analyse the characteristics - especially validity and reliability - of all the existing international tools that have been used to measure evidence-based clinical practice in physiotherapy. A systematic review conducted with data from exclusively quantitative-type studies synthesized in narrative format. An in-depth search of the literature was conducted in two phases: initial, structured, electronic search of databases and also journals with summarized evidence; followed by a residual-directed search in the bibliographical references of the main articles found in the primary search procedure. The studies included were assigned to members of the research team who acted as peer reviewers. Relevant information was extracted from each of the selected articles using a template that included the general characteristics of the instrument as well as an analysis of the quality of the validation processes carried out, by following the criteria of Terwee. Twenty-four instruments were found to comply with the review screening criteria; however, in all cases, they were found to be limited as regards the 'constructs' included. Besides, they can all be seen to be lacking as regards comprehensiveness associated to the validation process of the psychometric tests used. It seems that what constitutes a rigorously developed assessment instrument for EBP in physical therapy continues to be a challenge. © 2014 John Wiley & Sons, Ltd.

  17. Legal principles of regulatory administration and nuclear safety regulation

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Kyeong Hui; Cheong, Sang Kee [Hannam Univ., Taejon (Korea, Republic of)

    2000-12-15

    This research presents a critical analysis and evaluation of principles of administrative laws in order to provide framework of structural reform on the nuclear safety regulation system. The focus of this analysis and evaluation is centered around the area of origin of regulatory administrative laws; authorities of regulation; procedures of regulatory actions; regulatory enforcement; and administrative relief system. In chapter 2 the concept of regulatory administration is analysed. Chapter 3 identifies the origin of regulatory administration and the principles of administration laws. It also examines legal nature of the nuclear safety standard. In relation to regulatory authorities. Chapter 4 identifies role and responsibility of administration authorities and institutions. It also examines fundamental principles of delegation of power. Then the chapter discusses the nuclear safety regulation authorities and their roles and responsibilities. Chapter 5 classifies and examines regulatory administration actions. Chapter 6 evaluates enforcement measure for effectiveness of regulation. Finally, chapter 7 discusses the administrative relief system for reviewing unreasonable regulatory acts.

  18. Performance specifications for health physics instrumentation: portable instrumentation for use in normal work environments. Part 2. Test results

    International Nuclear Information System (INIS)

    Kenoyer, J.L.; Swinth, K.L.; Stoetzel, G.A.; Selby, J.M.

    1986-09-01

    The Pacific Northwest Laboratory evaluated a draft American National Standards Institute Standard N42.17 (ANSI N42.17) on performance specifications for health physics instrumentation through a project jointly funded by the US Department of Energy and the US Nuclear Regulatory Commission. The evaluation involved testing a representative cross section of instruments against criteria in the standard. This report presents results of the testing program. A brief history of the project is included in the introduction. The instrumentation tested is described in general terms (i.e., types, ranges); however, no direct relationship between the results and a specific instrument model is made in this report. Testing requirements in ANSI N42.17D4, Revision 1 (May 1985) are summarized and the methods by which the tests are performed are discussed. Brief descriptions of the testing equipment are included in the methods section of the report. More detailed information about the draft standard, testing requirements and procedures, and the test equipment is included in ''Performance Specifications for Health Physics Instrumentation - Portable Instrumentation for Use in Normal Work Environments, Part 1: Manual of Testing Procedures.'' Results of testing are given in two formats: test-by-test and instrument-by-instrument. Discussion is included on significant and interesting findings, on comparisons of results from the same type of instruments from same and different manufacturers, and on data grouped by manufacturer. Conclusions are made on the applicability and practicality of the proposed standard and on instrument performance. Changes that have been made to the proposed standard based on findings of the testing program are listed and discussed. 22 refs., 11 figs., 77 tabs

  19. Human factors in annunciation systems - Recommendations for a Canadian regulatory framework

    Energy Technology Data Exchange (ETDEWEB)

    Beattie, J D; Rochford, S; Vicente, K J [Humansystems Inc., ON (Canada)

    1997-09-01

    Under a contract with the Atomic Energy Control Board (AECB) of Canada, brief reviews were conducted of the annunciation systems in Canadian nuclear power plant control rooms; of regulatory practices in other countries and relevant international guidelines; and of the human factors literature related to annunciation systems. Based on these reviews, a framework is proposed for regulatory criteria which could be applied to new annunciation system designs. (author). 29 refs.

  20. Human factors in annunciation systems - Recommendations for a Canadian regulatory framework

    International Nuclear Information System (INIS)

    Beattie, J.D.; Rochford, S.; Vicente, K.J.

    1997-01-01

    Under a contract with the Atomic Energy Control Board (AECB) of Canada, brief reviews were conducted of the annunciation systems in Canadian nuclear power plant control rooms; of regulatory practices in other countries and relevant international guidelines; and of the human factors literature related to annunciation systems. Based on these reviews, a framework is proposed for regulatory criteria which could be applied to new annunciation system designs. (author). 29 refs

  1. 76 FR 13549 - Reducing Regulatory Burden; Retrospective Review Under E.O. 13563

    Science.gov (United States)

    2011-03-14

    ...'s regulatory program more effective and less burdensome in achieving its regulatory objectives by... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 15 CFR Chapter IX 50 CFR.... 13563 AGENCY: National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Request for...

  2. Integration of Bacterial Small RNAs in Regulatory Networks.

    Science.gov (United States)

    Nitzan, Mor; Rehani, Rotem; Margalit, Hanah

    2017-05-22

    Small RNAs (sRNAs) are central regulators of gene expression in bacteria, controlling target genes posttranscriptionally by base pairing with their mRNAs. sRNAs are involved in many cellular processes and have unique regulatory characteristics. In this review, we discuss the properties of regulation by sRNAs and how it differs from and combines with transcriptional regulation. We describe the global characteristics of the sRNA-target networks in bacteria using graph-theoretic approaches and review the local integration of sRNAs in mixed regulatory circuits, including feed-forward loops and their combinations, feedback loops, and circuits made of an sRNA and another regulator, both derived from the same transcript. Finally, we discuss the competition effects in posttranscriptional regulatory networks that may arise over shared targets, shared regulators, and shared resources and how they may lead to signal propagation across the network.

  3. Study on the establishment of efficient plan for regulatory activities at NPPs

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Sang Hun; Son, Mun Gyu [Korea Association for Nuclear Technology, Taejon (Korea, Republic of); Kang, Chang Sun; Yun, Jeong Ik; Ko, Hyun Seok; Lee, Young Wook [Seoul National Univ., Seoul (Korea, Republic of)

    2001-03-15

    In-operation regulatory activities at sites are very important and it should be improved to cope with accidents efficiently and quickly. In case of site survey and safety regulatory inspection regulatory system based on not regulatory headquarter but site regional office should be constructed. In other words, safety assurance and pending problem management considering site situation are needed. In this study, regulatory system at Nuclear Power Plant sites all over the world were reviewed and effective regulatory system of Korea are suggested to maximize the efficiency of license and regulatory manpower and consider the interest of local government and residents.

  4. Development of human factors design review guidelines(II)

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jung Woon; Oh, In Suk; Suh, Sang Moon; Lee, Hyun Chul [Korea Atomic Energy Research Institute, Taejon (Korea)

    1998-06-01

    The objective of this study is to develop human factors engineering program review guidelines and alarm system review guidelines in order to resolve the two major technical issues: 25. Human Factors Engineering Program Review Model and 26. Review Criteria for Human Factors Aspects of Advanced Controls and Instrumentation, which are related to the development of human factors safety regulation guides being performed by KINS. For the development of human factors program review guidelines, we made a Korean version of NUREG-0711 and added our comments by considering Korean regulatory situation and reviewing the reference documents of NUREG-0711. We also computerized the Korean version of NUREG-0711, additional comments, and selected portion of the reference documents for the developer of safety regulation guides in KINS to see the contents comparatively at a glance and use them easily. For the development of alarm system review guidelines, we made a Korean version of NUREG/CR-6105, which was published by NRC in 1994 as a guideline document for the human factors review of alarm systems. Then we will update the guidelines by reviewing the literature related to alarm design published after 1994. (author). 11 refs., 2 figs., 2 tabs.

  5. Development and evaluation of a social cognitive theory-based instrument to assess correlations for physical activity among people with spinal cord injury.

    Science.gov (United States)

    Wilroy, Jereme; Turner, Lori; Birch, David; Leaver-Dunn, Deidre; Hibberd, Elizabeth; Leeper, James

    2018-01-01

    People with spinal cord injury (SCI) are more susceptible to sedentary lifestyles because of the displacement of physical functioning and the copious barriers. Benefits of physical activity for people with SCI include physical fitness, functional capacity, social integration and psychological well-being. The purpose of this study was to develop and test a social cognitive theory-based instrument aimed to predict physical activity among people with SCI. An instrument was developed through the utilization and modification of previous items from the literature, an expert panel review, and cognitive interviewing, and tested among a sample of the SCI population using a cross-sectional design. Statistical analysis included descriptives, correlations, multiple regression, and exploratory factor analysis. The physical activity outcome variable was significantly and positively correlated with self-regulatory efficacy (r = 0.575), task self-efficacy (r = 0.491), self-regulation (r = 0.432), social support (r = 0.284), and outcome expectations (r = 0.247). Internal consistency for the constructs ranged from 0.82 to 0.96. Construct reliability values for the self-regulation (0.95), self-regulatory efficacy (0.96), task self-efficacy (0.94), social support (0.84), and outcome expectations (0.92) each exceeded the 0.70 a priori criteria. The factor analysis was conducted to seek modifications of current instrument to improve validity and reliability. The data provided support for the convergent validity of the five-factor SCT model. This study provides direction for further development of a valid and reliable instrument for predicting physical activity among people with SCI. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Reliability and Validity of Survey Instruments to Measure Work-Related Fatigue in the Emergency Medical Services Setting: A Systematic Review

    Science.gov (United States)

    2018-01-11

    Background: This study sought to systematically search the literature to identify reliable and valid survey instruments for fatigue measurement in the Emergency Medical Services (EMS) occupational setting. Methods: A systematic review study design wa...

  7. The Development of a PiSA Module for a Diagnosis of Instrumental Signals Associated with an ASSA Module for Accident Controls

    International Nuclear Information System (INIS)

    Koo, Kil Mo; Ahn, Kwang Il

    2010-05-01

    A review of a plant's accident management capabilities is one of the key elements in achieving regulatory closure of severe accident issues. During accidents, information and data from plant's instruments, as well as others sources, are essential for assessing the plant's status and response. Unlike for design basis accidents, there are inherently some uncertainties to instrumentation capabilities for severe accident conditions. There are many ways to obtain information during a severe accident. Moreover, precise measurements are not necessary. The redundancy and ruggedness of a plant's instrumentation provides considerable depth in the capability of existing designs. The circuit simulation analysis and diagnosis methods are used to assess instruments in detail when they give apparently abnormal readings. A new simulator, PiSA(Provability Instrument Signal Analysis) associated with ASSA(Abnormal Signal Simulation Analysis), through an analysis of the important circuits modeling under severe accident conditions has been designed. It has three main functions which are a signal processing tool, an accident management tool, and an additional guide from the initial screen. In this report, it can be simulated to the temperature characteristic analysis procedure of the PiSA including ASSA's data comparative methods and using specific signal processing under severe accident condition

  8. Fisheries regulatory regimes and resilience to climate change.

    Science.gov (United States)

    Ojea, Elena; Pearlman, Isaac; Gaines, Steven D; Lester, Sarah E

    2017-05-01

    Climate change is already producing ecological, social, and economic impacts on fisheries, and these effects are expected to increase in frequency and magnitude in the future. Fisheries governance and regulations can alter socio-ecological resilience to climate change impacts via harvest control rules and incentives driving fisher behavior, yet there are no syntheses or conceptual frameworks for examining how institutions and their regulatory approaches can alter fisheries resilience to climate change. We identify nine key climate resilience criteria for fisheries socio-ecological systems (SES), defining resilience as the ability of the coupled system of interacting social and ecological components (i.e., the SES) to absorb change while avoiding transformation into a different undesirable state. We then evaluate the capacity of four fisheries regulatory systems that vary in their degree of property rights, including open access, limited entry, and two types of rights-based management, to increase or inhibit resilience. Our exploratory assessment of evidence in the literature suggests that these regulatory regimes vary widely in their ability to promote resilient fisheries, with rights-based approaches appearing to offer more resilience benefits in many cases, but detailed characteristics of the regulatory instruments are fundamental.

  9. Regulatory aspects of criticality control in Australia

    International Nuclear Information System (INIS)

    Zimin, Sergei

    2003-01-01

    With the creation of Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) the Australian approach to criticality safety was revisited. Consistency with international best practices is required by the Act that created ARPANSA and this was applied to practices in criticality safety adopted in other countries. This required extensive regulatory efforts both in auditing the major Australian Nuclear Operator, Australian Nuclear Science and Technology Organisation (ANSTO), and assessing the existing in Australia criticality safety practices and implementing the required changes using the new legislative power of ARPANSA. The adopted regulatory approach is formulated through both the issued by ARPANSA licenses for nuclear installations (including reactors, fuel stores and radioactive waste stores) and the string of new regulatory documents, including the Regulatory Assessment Principles and the Regulatory Assessment Guidelines for criticality safety. The main features of the adopted regulation include the requirements of independent peer-review, ongoing refresher training coupled with annual accreditation and the reliance on the safe design rather than on an administrative control. (author)

  10. Identifying instruments to quantify financial management skills in adults with acquired cognitive impairments.

    Science.gov (United States)

    Engel, Lisa; Bar, Yael; Beaton, Dorcas E; Green, Robin E; Dawson, Deirdre R

    2016-01-01

    Financial management skills-that is, the skills needed to handle personal finances such as banking and paying bills-are essential to a person's autonomy, independence, and community living. To date, no comprehensive review of financial management skills instruments exists, making it difficult for clinicians and researchers to choose relevant instruments. The objectives of this review are to: (a) identify all available instruments containing financial management skill items that have been used with adults with acquired cognitive impairments; (b) categorize the instruments by source (i.e., observation based, self-report, proxy report); and (c) describe observation-based performance instruments by populations, overarching concepts measured, and comprehensiveness of financial management items. Objective (c) focuses on observation-based performance instruments as these measures can aid in situations where the person with cognitive impairment has poor self-awareness or where the proxy has poor knowledge of the person's current abilities. Two reviewers completed two systematic searches of five databases. Instruments were categorized by reviewing published literature, copies of the instruments, and/or communication with instrument authors. Comprehensiveness of items was based on nine key domains of financial management skills developed by the authors. A total of 88 discrete instruments were identified. Of these, 44 were categorized as observation-based performance and 44 as self- and/or proxy-reports. Of the 44 observation-based performance instruments, 8 had been developed for acquired brain injury populations and 24 for aging and dementia populations. Only 7 of the observation-based performance instruments had items spanning 6 or more of the 9 financial management skills domains. The majority of instruments were developed for aging and dementia populations, and few were comprehensive. This review provides foundation for future instrument psychometric and clinimetric

  11. 75 FR 21871 - Spring 2010 Regulatory Agenda

    Science.gov (United States)

    2010-04-26

    ... Review 10/00/10 Regulatory Flexibility Analysis Required: No Agency Contact: Tad Wysor, Environmental...: wysor.tad@epamail.epa.gov Tom Eagles, Environmental Protection Agency, Air and Radiation, 6103A...

  12. Review process for license renewal applications

    International Nuclear Information System (INIS)

    Craig, John W.; Kuo, P.T.

    1991-01-01

    In preparation for license renewal reviews, the Nuclear Regulatory Commission has recently published for public review and comment a proposed rule for license renewal and a draft Standard Review Plan as well as a draft Regulatory Guide relating to the implementation of the proposed rule. In support of future license renewal applications, the nuclear industry has also submitted 11 industry reports for NRC review and approval. This paper briefly describe how these parallel regulatory and industry activities will be factored into the NRC review process for license renewal. (author)

  13. Regulatory role of prolactin in paternal behavior in male parents: A narrative review

    Directory of Open Access Journals (Sweden)

    F Hashemian

    2016-01-01

    Full Text Available In all mammalian species, a combination of neuroendocrine and experiential factors contributes to the emergence of remarkable behavioral changes observed in parental behavior. Yet, our understanding of neuroendocrine bases of paternal behavior in humans is still preliminary and more research is needed in this area. In the present review, the authors summarized hormonal bases of paternal behavior in both human and nonhuman mammalian species and focused on studies on the regulatory role of prolactin in occurrence of paternal behavior. All peer-reviewed journal articles published before 2015 for each area discussed (parental brain, hormonal bases of maternal behavior, hormonal bases of paternal behavior and the role of prolactin in regulation of paternal behavior in nonhuman mammalian species, hormonal bases of paternal behavior and the role of prolactin in regulation of paternal behavior in humans were searched by PubMed, Medline, and Scopus for original research and review articles. Publications between 1973 and 2015 were included. Similar to female parents, elevated prolactin levels in new fathers most probably contribute to child-caring behavior and facilitate behavioral and emotional states attributed to child care. Moreover, elevated parental prolactin levels after childbirth decrease the parents′ libidos so that they invest more in parental care than in fertility behavior. According to the available clinical studies, elevation in the amounts of prolactin levels after childbirth in male parents are probably associated with paternal behavior observed in humans.

  14. Conformance to Regulatory Guide 1.97, Arkansas Nuclear One, Unit No. 1

    International Nuclear Information System (INIS)

    Stoffel, J.W.

    1985-08-01

    This EG and G Idaho, Inc., report reviews the submittals for Regulatory Guide 1.97 for Unit No. 1 of Arkansas Nuclear One and identifies areas of nonconformance to the regulatory guide. Exceptions to Regulatory Guide 1.97 are evaluated and those areas where sufficient basis for acceptability is not provided are identified

  15. Interleukin-2 and STAT5 in regulatory T cell development and function

    OpenAIRE

    Mahmud, Shawn A.; Manlove, Luke S.; Farrar, Michael A.

    2013-01-01

    Interleukin-2 and its downstream target STAT5 have effects on many aspects of immune function. This has been perhaps best documented in regulatory T cells. In this review we summarize the initial findings supporting a role for IL2 and STAT5 in regulatory T cell development and outline more recent studies describing how this critical signaling pathway entrains regulatory T cell differentiation and affects regulatory T cell function.

  16. Transcription regulatory networks analysis using CAGE

    KAUST Repository

    Tegné r, Jesper N.; Bjö rkegren, Johan L M; Ravasi, Timothy; Bajic, Vladimir

    2009-01-01

    and the fine interplay between regulatory proteins and the promoter structure governing the combinatorial regulation of gene expression. In this chapter we review how the CAGE data can be integrated with other measurements such as expression, physical

  17. Globalisation and Governance: Educational Policy Instruments and Regulatory Arrangements

    Science.gov (United States)

    Mok, Ka-Ho

    2005-07-01

    For more than a decade, the economic, social, political and cultural effects of globalisation have been central topics of debate. Those who see globalisation as a combination of economic transactions and worldwide telecommunications tend to believe that its impact is profound, inasmuch as it is fundamentally altering the way in which we live and creating hybrid cultural styles. No country is immune from the effects of globalisation, and controversy continues to reign about its positive and negative consequences. The present study identifies and examines numerous challenges posed by globalisation and their implications for educational restructuring, with special attention being given to new forms of governance; the relation between the state, the market and civil society; and governmental policy instruments for education.

  18. Nuclear Regulatory Authority Act, 2015 (Act 895)

    International Nuclear Information System (INIS)

    2015-04-01

    An Act to establish a Nuclear Regulatory Authority in Ghana. This Act provides for the regulation and management of activities and practices for the peaceful use of nuclear material or energy, and to provide for the protection of persons and the environment against the harmful effects of radiation; and to ensure the effective implementation of the country’s international obligations and for related matters. This Act replaced the Radiation Protection Instrument, of 1993 (LI 1559).

  19. Reliability programs for nuclear power plants. Regulatory standard S-98 revision 1

    International Nuclear Information System (INIS)

    2005-07-01

    The purpose of this regulatory standard is to help assure, in accordance with the purpose of the Nuclear Safety and Control Act (NSCA), that a licensee who constructs or operates a nuclear power plant (NPP) develops and implements a reliability program that assures that the systems important to safety at the plant can and will meet their defined design and performance specifications at acceptable levels of reliability throughout the lifetime of the facility. This regulatory standard describes the requirements of a reliability program for a nuclear power plant. The licensee shall implement the requirements described in this regulatory standard when a condition of a licence or other legally enforceable instrument so requires.(author)

  20. Diabetes-related emotional distress instruments: a systematic review of measurement properties.

    Science.gov (United States)

    Lee, Jiyeon; Lee, Eun-Hyun; Kim, Chun-Ja; Moon, Seung Hei

    2015-12-01

    The objectives of this study were to identify all available diabetes-related emotional distress instruments and evaluate the evidence regarding their measurement properties to help in the selection of the most appropriate instrument for use in practice and research. A systematic literature search was performed. PubMed, Embase, CINAHL, and PsycINFO were searched systematically for articles on diabetes-related emotional distress instruments. The Consensus-based Standards for the Selection of Health Measurement Instruments checklist was used to evaluate the methodological quality of the identified studies. The quality of results with respect to the measurement properties of each study was evaluated using Terwee's quality criteria. An ancillary meta-analysis was performed. Of the 2345 articles yielded by the search, 19 full-text articles evaluating 6 diabetes-related emotional distress instruments were included in this study. No instrument demonstrated evidence for all measurement properties. The Problem Areas in Diabetes scale (PAID) was the most frequently studied and the best validated of the instruments. Pooled summary estimates of the correlation coefficient between the PAID and serum glycated hemoglobin revealed a positive but weak correlation. No diabetes-related emotional distress instrument demonstrated evidence for all measurement properties. No instrument was better than another, although the PAID was the best validated and is thus recommended for use. Further psychometric studies of the diabetes-related emotional distress instruments with rigorous methodologies are required. Copyright © 2015 Elsevier Ltd. All rights reserved.

  1. Regulatory pathways for vaccines for developing countries.

    Science.gov (United States)

    Milstien, Julie; Belgharbi, Lahouari

    2004-01-01

    Vaccines that are designed for use only in developing countries face regulatory hurdles that may restrict their use. There are two primary reasons for this: most regulatory authorities are set up to address regulation of products for use only within their jurisdictions and regulatory authorities in developing countries traditionally have been considered weak. Some options for regulatory pathways for such products have been identified: licensing in the country of manufacture, file review by the European Medicines Evaluation Agency on behalf of WHO, export to a country with a competent national regulatory authority (NRA) that could handle all regulatory functions for the developing country market, shared manufacturing and licensing in a developing country with competent manufacturing and regulatory capacity, and use of a contracted independent entity for global regulatory approval. These options have been evaluated on the basis of five criteria: assurance of all regulatory functions for the life of the product, appropriateness of epidemiological assessment, applicability to products no longer used in the domestic market of the manufacturing country, reduction of regulatory risk for the manufacturer, and existing rules and regulations for implementation. No one option satisfies all criteria. For all options, national infrastructures (including the underlying regulatory legislative framework, particularly to formulate and implement local evidence-based vaccine policy) must be developed. WHO has led work to develop this capacity with some success. The paper outlines additional areas of action required by the international community to assure development and use of vaccines needed for the developing world. PMID:15042235

  2. Nuclear Regulatory Infrastructure in the Philippines

    International Nuclear Information System (INIS)

    Leonin, Teofilo V. Jr.

    2015-01-01

    Regulating the use of radioactive materials in the Philippines involves the adherence to legislation, regulations, standards and regulatory guides. It is based on a detailed review and assessment of the radiation safety program of owners and users of these materials and associated equipment against safety requirements and on additional verification of the operating practices and procedures. Republic Acts 5207 and 2067, both as amended, are implemented through the regulations which are titled Code of PNRI Regulations or CPRs are developed and issued together with supporting regulatory guides, Bulletins and other documents detailing the safety requirements. These issuance adhere to internationally accepted requirements on radiation protection, and nuclear safety and security, as well as safeguards. Design documents and technical Specifications of important radioactive materials, equipment and components are required to be submitted and reviewed by the PNRI before the issuance of an authorization in the form of a license Verification of adherence to regulations and safety requirements are periodically checked through the implementation of an inspection and enforcement program. The ISO certified regulatory management system of PNRI is documented in a QMS manual that provides guidance on all work processes. It involves systematic planning and evaluation of activities, multiple means of getting feedback on the work processes, and continuous efforts to improve its effectiveness. Efforts are implemented in order to strengthen the transparency openness, independence, technical competence and effectiveness of the regulatory body. (author)

  3. Liquid chromatography coupled to on-line post column derivatization for the determination of organic compounds: A review on instrumentation and chemistries

    International Nuclear Information System (INIS)

    Zacharis, Constantinos K.; Tzanavaras, Paraskevas D.

    2013-01-01

    Graphical abstract: -- Highlights: •Review on liquid chromatography coupled to post-column derivatization. •Overview of instrumentation for post-column derivatization. •Post-column chemistries for analysis of organic compounds. -- Abstract: Analytical derivatization either in pre or post column modes is one of the most widely used sample pretreatment techniques coupled to liquid chromatography. In the present review article we selected to discuss the post column derivatization mode for the analysis of organic compounds. The first part of the review focuses to the instrumentation of post-column setups including not only fundamental components such as pumps and reactors but also less common parts such as static mixers and back-pressure regulators; the second part of the article discusses the most popular “chemistries” that are involved in post column applications, including reagent-less approaches and new sensing platforms such as the popular gold nanoparticles. Some representative recent applications are also presented as tables

  4. Liquid chromatography coupled to on-line post column derivatization for the determination of organic compounds: A review on instrumentation and chemistries

    Energy Technology Data Exchange (ETDEWEB)

    Zacharis, Constantinos K., E-mail: zacharis@chem.auth.gr [Laboratory of Analytical Chemistry, Department of Chemistry, Aristotelian University of Thessaloniki, GR-54124 Thessaloniki (Greece); Department of Food Technology, School of Food Technology and Nutrition, Alexander Technological Educational Institute (ATEI) of Thessaloniki, 57400 Thessaloniki (Greece); Tzanavaras, Paraskevas D., E-mail: ptzanava@chem.auth.gr [Laboratory of Analytical Chemistry, Department of Chemistry, Aristotelian University of Thessaloniki, GR-54124 Thessaloniki (Greece)

    2013-10-10

    Graphical abstract: -- Highlights: •Review on liquid chromatography coupled to post-column derivatization. •Overview of instrumentation for post-column derivatization. •Post-column chemistries for analysis of organic compounds. -- Abstract: Analytical derivatization either in pre or post column modes is one of the most widely used sample pretreatment techniques coupled to liquid chromatography. In the present review article we selected to discuss the post column derivatization mode for the analysis of organic compounds. The first part of the review focuses to the instrumentation of post-column setups including not only fundamental components such as pumps and reactors but also less common parts such as static mixers and back-pressure regulators; the second part of the article discusses the most popular “chemistries” that are involved in post column applications, including reagent-less approaches and new sensing platforms such as the popular gold nanoparticles. Some representative recent applications are also presented as tables.

  5. Regulatory and licensee surveys

    International Nuclear Information System (INIS)

    2009-01-01

    Prior to the workshop two CSNI/WGHOF surveys were distributed. One survey was directed at regulatory bodies and the other was directed at plant licensees. The surveys were: 1 - Regulatory Expectations of Licensees' Arrangements to Ensure Suitable Organisational Structure, Resources and Competencies to Manage Safety (sent to WGHOF regulatory members). The survey requested that the respondents provide a brief overview of the situation related to plant organisations in their country, their regulatory expectations and their formal requirements. The survey addressed three subjects: the demonstration and documentation of organisational structures, resources and competencies, organisational changes, issues for improvement (for both current and new plants). Responses were received from eleven regulatory bodies. 2 - Approaches to Justify Organisational Suitability (sent to selected licensees). The purpose of the survey to was to gain an understanding of how licensees ensure organisational suitability, resources and competencies. This information was used to assist in the development of the issues and subjects that were addressed at the group discussion sessions. Responses were received from over fifteen licensees from nine countries. The survey requested that the licensees provide information on how they ensure effective organisational structures at their plants. The survey grouped the questions into the following four categories: organisational safety functions, resource and competence, decision-making and communication, good examples and improvement needs. The findings from these surveys were used in conjunction with other factors to identify the key issues for the workshop discussion sessions. The responses from these two surveys are discussed briefly in Sections 4 and 5 of this report. More extensive reviews of the regulatory and licensee responses are provided in Appendix 1

  6. Regulatory experiences from the spent fuel disposal step-wise implementation

    International Nuclear Information System (INIS)

    Heinonen, Jussi

    2016-01-01

    How to ensure regulatory readiness in different steps? Criteria for decision making: • Up-to-date safety requirements; • What is enough in this licensing step? Review strategy: • What is relevant in this licensing step?; • How to address (top-down or bottom-up review, own analysis, inspection)?Expertise: • Strategy for developing regulatory competences and resources; • Adapted to licensing step in question. Interaction with applicant: • important for mutual understanding; • Address main safety questions during pre-licensing – no surprises!

  7. Quality of life instruments for economic evaluations in health and social care for older people: a systematic review.

    Science.gov (United States)

    Makai, Peter; Brouwer, Werner B F; Koopmanschap, Marc A; Stolk, Elly A; Nieboer, Anna P

    2014-02-01

    Gaining health may not be the main goal of healthcare services aimed at older people, which may (also) seek to improve wellbeing. This emphasizes the need of finding appropriate outcome measures for economic evaluation of such services, particularly in long-term care, capturing more than only health-related quality of life (HrQol). This review assesses the usefulness of HrQol and wellbeing instruments for economic evaluations specifically aimed at older people, focusing on generic and preference-based questionnaires measuring wellbeing in particular. We systematically searched six databases and extracted instruments used to assess HrQol and wellbeing outcomes. Instruments were compared based on their usefulness for economic evaluation of services aimed at older people (dimensions measured, availability of utility scores, extent of validation). We identified 487 articles using 34 generic instruments: 22 wellbeing (two of which were preference-based) and 11 HrQol instruments. While standard HrQol instruments measure physical, social and psychological dimensions, wellbeing instruments contain additional dimensions such as purpose in life and achievement, security, and freedom. We found four promising wellbeing instruments for inclusion in economic evaluation: Ferrans and Powers QLI and the WHO-Qol OLD, ICECAP-O and the ASCOT. Ferrans and Powers QLI and the WHO-Qol OLD are widely validated but lack preference-weights while for ICECAP-O and the ASCOT preference-weights are available, but are less widely validated. Until preference-weights are available for the first two instruments, the ICECAP-O and the ASCOT currently appear to be the most useful instruments for economic evaluations in services aimed at older people. Their limitations are that (1) health dimensions may be captured only partially and (2) the instruments require further validation. Therefore, we currently recommend using the ICECAP-O or the ASCOT alongside the EQ-5D or SF-6D when evaluating interventions

  8. Experience and regulatory activities on advanced instrumentation and control systems applied to nuclear power plants in Korea

    International Nuclear Information System (INIS)

    Kim, B.R.

    1995-01-01

    This paper describes the status for applying microprocessor-based systems to nuclear power plants in Korea and the regulatory activities performed by Korea Institute of Nuclear Safety (KINS). And this presents the development of safety and regulatory technology for advanced I and C systems that has been carried out as a part of the next generation reactor development program in Korea. (author). 3 refs, 4 figs, 1 tab

  9. An evaluation of instruments for scoring physiological and behavioral cues of pain, non-pain related distress, and adequacy of analgesia and sedation in pediatric mechanically ventilated patients: A systematic review.

    Science.gov (United States)

    Dorfman, Tamara L; Sumamo Schellenberg, Elizabeth; Rempel, Gwen R; Scott, Shannon D; Hartling, Lisa

    2014-04-01

    Advancing technology allows for successful treatment of children with life-threatening illnesses. Effectively assessing and optimally treating a child's distress during their stay in the Pediatric Intensive Care Unit (PICU) is paramount. Objective measures of distress in mechanically ventilated pediatric patients are increasingly available but few have been evaluated. The objectives of this systematic review were to identify available instruments appropriate for measuring physiological and behavioral cues of pain, non-pain related distress, and adequacy of analgesia and sedation in mechanically ventilated pediatric patients, and evaluate these instruments in terms of their psychometric properties. A systematic review of original and validation reports of objective instruments to measure pain and non-pain related distress, and adequacy of analgesia and sedation in mechanically ventilated PICU patients was undertaken. A comprehensive search was conducted in 10 databases from January 1970 to June 2011. Reference lists of relevant articles were reviewed to identify additional articles. Studies were included in the review if they met pre-established eligibility criteria. Two independent reviewers reviewed studies for inclusion, assessed quality, and extracted data. Twenty-five articles were included, identifying 15 instruments. The instruments had different foci including: assessing pain, non-pain related distress, and sedation (n=2); assessing pain exclusively (n=4); assessing sedation exclusively (n=7), assessing sedation in mechanically ventilated muscle relaxed PICU patients (n=1); and assessing delirium in mechanically ventilated PICU patients (n=1). The Comfort Scale demonstrated the greatest clinical utility in the assessment of pain, non-pain related distress, and sedation in mechanically ventilated pediatric patients. Modified FLACC and the MAPS are more appropriate, however, for the assessment of procedural pain and other brief painful events. More work is

  10. Scoping review of pediatric tonsillectomy quality of life assessment instruments.

    Science.gov (United States)

    Kao, Stephen Shih-Teng; Peters, Micah D J; Dharmawardana, Nuwan; Stew, Benjamin; Ooi, Eng Hooi

    2017-10-01

    Sleep-disordered breathing or recurrent tonsillitis have detrimental effects on the child's physical health and quality of life. Tonsillectomy is commonly performed to treat these common conditions and improve the child's quality of life. This scoping review aims to present a comprehensive and descriptive analysis of quality of life questionnaires as a resource for clinicians and researchers when deciding which tool to use when assessing the quality of life effects after tonsillectomy. A comprehensive search strategy was undertaken across MEDLINE (PubMed), CINAHL, Embase, and Cochrane CENTRAL. Quality of life questionnaires utilized in studies investigating pediatric patients undergoing tonsillectomy for chronic tonsillitis or sleep-disordered breathing were included. Methodological quality and data extraction were conducted as per Joanna Briggs Institute methodology. Ten questionnaires were identified, consisting of six generic and four disease-specific instruments. The Pediatric Quality of Life Inventory was the most commonly utilized generic questionnaire. The Obstructive Sleep Apnea-18 was the most commonly utilized disease-specific questionnaire. This review identified a range of generic and disease-specific quality of life questionnaires utilized in pediatric patients who have undergone tonsillectomy with or without adenoidectomy for sleep-disordered breathing or chronic tonsillitis. Important aspects of each questionnaire have been summarized to aid researchers and clinicians in choosing the appropriate questionnaire when evaluating the quality of life effects of tonsillectomy. NA Laryngoscope, 127:2399-2406, 2017. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

  11. Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel

    Science.gov (United States)

    Fregni, F; Nitsche, MA; Loo, C.K.; Brunoni, AR; Marangolo, P; Leite, J; Carvalho, S; Bolognini, N; Caumo, W; Paik, NJ; Simis, M; Ueda, K; Ekhitari, H; Luu, P; Tucker, DM; Tyler, WJ; Brunelin, J; Datta, A; Juan, CH; Venkatasubramanian, G; Boggio, PS; Bikson, M

    2014-01-01

    The field of transcranial electrical stimulation (tES) has experienced significant growth in the past 15 years. One of the tES techniques leading this increased interest is transcranial direct current stimulation (tDCS). Significant research efforts have been devoted to determining the clinical potential of tDCS in humans. Despite the promising results obtained with tDCS in basic and clinical neuroscience, further progress has been impeded by a lack of clarity on international regulatory pathways. We therefore convened a group of research and clinician experts on tDCS to review the research and clinical use of tDCS. In this report, we review the regulatory status of tDCS, and we summarize the results according to research, off-label and compassionate use of tDCS in the following countries: Australia, Brazil, France, Germany, India, Iran, Italy, Portugal, South Korea, Taiwan and United States. Research use, off label treatment and compassionate use of tDCS are employed in most of the countries reviewed in this study. It is critical that a global or local effort is organized to pursue definite evidence to either approve and regulate or restrict the use of tDCS in clinical practice on the basis of adequate randomized controlled treatment trials. PMID:25983531

  12. Regulatory governance of telecommunications liberalisation in Taiwan

    International Nuclear Information System (INIS)

    Cheng, Kuo-Tai; Hebenton, Bill

    2008-01-01

    This paper examines the changing role of government and market in regulating the telecommunications sector from since 1996 in Taiwan. It contextualises the theoretical aspects of regulatory governance for institutional design and practices, and reviews the concepts and mechanisms for appraising privatisation and regulatory systems. Using a conceptual framework for researching privatisation and regulation, it describes the process and issues pertinent to telecommunications liberalisation and privatisation in Taiwan, supported by a brief presentation of theoretical points of view as well as practitioners' views. The paper presents results concerning criteria for appraising privatisation and regulatory governance and considers policy lessons that can be learned from the experiences of the Taiwanese telecommunications sector's liberalisation. (author)

  13. Regulatory governance of telecommunications liberalisation in Taiwan

    Energy Technology Data Exchange (ETDEWEB)

    Cheng, Kuo-Tai [Department of Regional Studies in Humanity and Social Sciences, National Hsin-Chu University of Education, No. 521 Nan-Da Road, Hsin-Chu 300 (China); Hebenton, Bill [School of Law, University of Manchester, M13 9PP (United Kingdom)

    2008-12-15

    This paper examines the changing role of government and market in regulating the telecommunications sector from since 1996 in Taiwan. It contextualises the theoretical aspects of regulatory governance for institutional design and practices, and reviews the concepts and mechanisms for appraising privatisation and regulatory systems. Using a conceptual framework for researching privatisation and regulation, it describes the process and issues pertinent to telecommunications liberalisation and privatisation in Taiwan, supported by a brief presentation of theoretical points of view as well as practitioners' views. The paper presents results concerning criteria for appraising privatisation and regulatory governance and considers policy lessons that can be learned from the experiences of the Taiwanese telecommunications sector's liberalisation. (author)

  14. Safety Committees for Argentinean Research Reactor - Regulatory Issues

    International Nuclear Information System (INIS)

    Perrin, Carlos D.

    2009-01-01

    In the field of radiological and nuclear safety, the Nuclear Regulatory Authority (ARN) of Argentina controls three research reactors and three critical assemblies, by means of evaluations, audits and inspections, in order to ensure the fulfillment of the requirements established in the Licenses, in the Regulatory Standards and in the Mandatory Documentation in general. From the Nuclear Regulatory Authority's point of view, within the general process of research reactors safety management, the Operational Organization self verification of radiological and nuclear safety plays an outstanding role. In this aspect the ARN has established specific requirements in the Regulatory Standards, in the Operation Licenses and in the Operational Limits and Conditions. These requirements include the figure of different safety committees, which act as reviewers or advisers in diverse situations. This paper describes the main characteristics of the committees, their function, scope and the regulatory documents where the requirements are included. (author)

  15. The regulatory framework of trade finance: from BASEL I to BASEL III

    Directory of Open Access Journals (Sweden)

    Claudia BAICU

    2011-09-01

    Full Text Available The global crisis revealed several weaknesses in the international framework of banking regulation. Consequently, the Basel Committee on Banking Supervision (BCBS proposed a package of measures to strengthen the resilience of the banking sector. Besides the positive effects they have on financial stability, the new regulatory provisions affect the ability of banks to provide trade finance. Therefore, the banking industry considers that regulators have not taken into account the low-risk profile of activity. Starting from this premise, the paper consists of three parts. In the first part, the role and objectives of the BCBS are presented; the second part is designed to review the most important trade instruments and to underline the tendencies in trade finance; finally, the last part highlights the regulation of trade finance under the Basel I, Basel II and Basel III regimes, and some unintended consequences of the Basel III framework.

  16. Manufacturing human mesenchymal stem cells at clinical scale: process and regulatory challenges.

    Science.gov (United States)

    Jossen, Valentin; van den Bos, Christian; Eibl, Regine; Eibl, Dieter

    2018-05-01

    Human mesenchymal stem cell (hMSC)-based therapies are of increasing interest in the field of regenerative medicine. As economic considerations have shown, allogeneic therapy seems to be the most cost-effective method. Standardized procedures based on instrumented single-use bioreactors have been shown to provide billion of cells with consistent product quality and to be superior to traditional expansions in planar cultivation systems. Furthermore, under consideration of the complex nature and requirements of allogeneic hMSC-therapeutics, a new equipment for downstream processing (DSP) was successfully evaluated. This mini-review summarizes both the current state of the hMSC production process and the challenges which have to be taken into account when efficiently producing hMSCs for the clinical scale. Special emphasis is placed on the upstream processing (USP) and DSP operations which cover expansion, harvesting, detachment, separation, washing and concentration steps, and the regulatory demands.

  17. Review of decision methodologies for evaluating regulatory actions affecting public health and safety

    International Nuclear Information System (INIS)

    Hendrickson, P.L.; McDonald, C.L.; Schilling, A.H.

    1976-12-01

    This report examines several aspects of the problems and choices facing the governmental decision maker who must take regulatory actions with multiple decision objectives and attributes. Particular attention is given to the problems facing the U.S. Nuclear Regulatory Commission (NRC) and to the decision attribute of chief concern to NRC, the protection of human health and safety, with emphasis on nuclear power plants. The study was undertaken to provide background information for NRC to use in refining its process of value/impact assessment of proposed regulatory actions. The principal conclusion is that approaches to rationally consider the value and impact of proposed regulatory actions are available. These approaches can potentially improve the decision-making process and enable the agency to better explain and defend its decisions. They also permit consistent examination of the impacts, effects of uncertainty and sensitivity to various assumptions of the alternatives being considered. Finally, these approaches can help to assure that affected parties are heard and that technical information is used appropriately and to the extent possible. The principal aspects of the regulatory decision problem covered in the report are: the legal setting for regulatory decisions which affect human health and safety, elements of the decision-making process, conceptual approaches to decision making, current approaches to decision making in several Federal agencies, and the determination of acceptable risk levels

  18. Instruments assessing attitudes toward or capability regarding self-management of osteoarthritis: a systematic review of measurement properties.

    Science.gov (United States)

    Eyles, J P; Hunter, D J; Meneses, S R F; Collins, N J; Dobson, F; Lucas, B R; Mills, K

    2017-08-01

    To make a recommendation on the "best" instrument to assess attitudes toward and/or capabilities regarding self-management of osteoarthritis (OA) based on available measurement property evidence. Electronic searches were performed in MEDLINE, EMBASE, CINAHL and PsychINFO (inception to 27 December 2016). Two reviewers independently rated measurement properties using the Consensus-based Standards for the selection of Health Measurement Instruments (COSMIN) 4-point scale. Best evidence synthesis was determined by considering COSMIN ratings for measurement property results and the level of evidence available for each measurement property of each instrument. Eight studies out of 5653 publications met the inclusion criteria, with eight instruments identified for evaluation: Multidimensional Health Locus of Control (MHLC), Perceived Behavioural Control (PBC), Patient Activation Measure (PAM), Educational Needs Assessment (ENAT), Stages of Change Questionnaire in Osteoarthritis (SCQOA), Effective Consumer Scale (EC-17) and Perceived Efficacy in Patient-Physician Interactions five item (PEPPI-5) and ten item scales. Measurement properties assessed for these instruments included internal consistency (k = 8), structural validity (k = 8), test-retest reliability (k = 2), measurement error (k = 1), hypothesis testing (k = 3) and cross-cultural validity (k = 3). No information was available for content validity, responsiveness or minimal important change (MIC)/minimal important difference (MID). The Dutch PEPPI-5 demonstrated the best measurement property evidence; strong evidence for internal consistency and structural validity but limited evidence for reliability and construct validity. Although PEPPI-5 was identified as having the best measurement properties, overall there is a poor level of evidence currently available concerning measurement properties of instruments to assess attitudes toward and/or capabilities regarding osteoarthritis self-management. Further

  19. Regulation for continuous improvements - the new regulatory strategy of SKI

    International Nuclear Information System (INIS)

    Hoegberg, L.; Svensson, G.; Viktorsson, C.

    1998-01-01

    This paper describes the new regulatory objectives and strategy of the Swedish Nuclear Power Inspectorate. Factors that have influenced the development of the regulatory strategy, including an international peer review, are discussed. In addition to general technical requirements for a defence in depth, the new strategy strongly focuses on the quality of plant safety management processes, to be monitored by process-oriented inspections. Also, quality assurance of regulatory activities is stressed. Experience gained so far shows that the regulatory approach chosen in Sweden promotes utility self assessment, quality of safety management and ownership of safety work within the utility staff. (author)

  20. Patient-reported outcome measures in dysphagia: a systematic review of instrument development and validation.

    Science.gov (United States)

    Patel, D A; Sharda, R; Hovis, K L; Nichols, E E; Sathe, N; Penson, D F; Feurer, I D; McPheeters, M L; Vaezi, M F; Francis, David O

    2017-05-01

    Patient-reported outcome (PRO) measures are commonly used to capture patient experience with dysphagia and to evaluate treatment effectiveness. Inappropriate application can lead to distorted results in clinical studies. A systematic review of the literature on dysphagia-related PRO measures was performed to (1) identify all currently available measures and (2) to evaluate each for the presence of important measurement properties that would affect their applicability. MEDLINE via the PubMed interface, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument database were searched using relevant vocabulary terms and key terms related to PRO measures and dysphagia. Three independent investigators performed abstract and full text reviews. Each study meeting criteria was evaluated using an 18-item checklist developed a priori that assessed multiple domains: (1) conceptual model, (2) content validity, (3) reliability, (4) construct validity, (6) scoring and interpretation, and (7) burden and presentation. Of 4950 abstracts reviewed, a total of 34 dysphagia-related PRO measures (publication year 1987-2014) met criteria for extraction and analysis. Several PRO measures were of high quality (MADS for achalasia, SWAL-QOL and SSQ for oropharyngeal dysphagia, PROMIS-GI for general dysphagia, EORTC-QLQ-OG25 for esophageal cancer, ROMP-swallowing for Parkinson's Disease, DSQ-EoE for eosinophilic esophagitis, and SOAL for total laryngectomy-related dysphagia). In all, 17 met at least one criterion per domain. Thematic deficiencies in current measures were evident including: (1) direct patient involvement in content development, (2) empirically justified dimensionality, (3) demonstrable responsiveness to change, (4) plan for interpreting missing responses, and (5) literacy level assessment. This is the first comprehensive systematic review assessing developmental properties of all available dysphagia-related PRO measures. We

  1. Economic instruments for obesity prevention: results of a scoping review and modified delphi survey

    Directory of Open Access Journals (Sweden)

    LaFrance Jeffrey

    2011-10-01

    Full Text Available Abstract Background Comprehensive, multi-level approaches are required to address obesity. One important target for intervention is the economic domain. The purpose of this study was to synthesize existing evidence regarding the impact of economic policies targeting obesity and its causal behaviours (diet, physical activity, and to make specific recommendations for the Canadian context. Methods Arksey and O'Malley's (2005 methodological framework for conducting scoping reviews was adopted for this study and this consisted of two phases: 1 a structured literature search and review, and 2 consultation with experts in the research field through a Delphi survey and an in-person expert panel meeting in April 2010. Results Two key findings from the scoping review included 1 consistent evidence that weight outcomes are responsive to food and beverage prices. The debate on the use of food taxes and subsidies to address obesity should now shift to how best to address practical issues in designing such policies; and 2 very few studies have examined the impact of economic instruments to promote physical activity and clear policy recommendations cannot be made at this time. Delphi survey findings emphasised the relatively modest impact any specific economic instrument would have on obesity independently. Based on empirical evidence and expert opinion, three recommendations were supported. First, to create and implement an effective health filter to review new and current agricultural polices to reduce the possibility that such policies have a deleterious impact on population rates of obesity. Second, to implement a caloric sweetened beverage tax. Third, to examine how to implement fruit and vegetable subsidies targeted at children and low income households. Conclusions In terms of economic interventions, shifting from empirical evidence to policy recommendation remains challenging. Overall, the evidence is not sufficiently strong to provide clear policy

  2. 75 FR 54917 - Criteria for Nominating Materials Licensees for the U.S. Nuclear Regulatory Commission's Agency...

    Science.gov (United States)

    2010-09-09

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0294] Criteria for Nominating Materials Licensees for the U.S. Nuclear Regulatory Commission's Agency Action Review Meeting AGENCY: Nuclear Regulatory Commission. ACTION: Request for comment. SUMMARY: It is the policy of the U.S. Nuclear Regulatory Commission...

  3. Survey on requirements for independent reviews and inspections of electrical and I and C equipment

    Energy Technology Data Exchange (ETDEWEB)

    Byman, Karin; Groenkvist, Stefan; Egerbo, Anders; Nilsson, Thomas (AaF Consult AB, Stockholm (Sweden))

    2009-03-15

    In this survey, licensing procedures for the implementation of different kinds of components and systems in nuclear power plants have been studied in four European countries: Belgium (Finland), Germany, and Switzerland. The main focus has been to describe the general features of the licensing procedures for electrical and for instrumentation and control (IandC) equipment and systems. The regulatory framework for the operation of nuclear power plants in Belgium is based on the American regulations. The licensing procedure for each modification of significance for the safety of a plant is carried out by the authorised inspection organisation (AVN), which follows its own procedures for the review of the modification file, the commissioning, and conformity check of the installation. These procedures are general and independent of the technical domain of the equipment or system and AVN uses the US regulations standard review plan (SRP) as a reference for technical reviews. The Federal Agency for Nuclear Control (FANC) is responsible for the surveillance of all nuclear activities in Belgium, but the private non-profit authorised inspection organisation (AVN) does perform inspections and other regulatory tasks delegated by FANC. Controls of electrical components and systems with regard to the general Belgian electrical regulations are performed by accredited inspection organisations. The regulatory framework for the safety of nuclear activities in Finland is domestic and detailed safety requirements are provided by the Radiation and Nuclear Safety Authority (STUK). They cover specific requirements for the licensing procedure for electrical and IandC equipment. In Finland, there are no general differences in the licensing procedure for electrical, instrumentation, and mechanical equipment and the licensing procedure is basically the same for all types of systems, structures and equipment. STUK has the responsibility for the regulatory control in Finland and may seek

  4. Instrumentation availability during severe accidents for a boiling water reactor with a Mark I containment

    International Nuclear Information System (INIS)

    Arcieri, W.C.; Hanson, D.J.

    1992-02-01

    In support of the US Nuclear Regulatory Commission Accident Management Research Program, the availability of instruments to supply accident management information during a broad range of severe accidents is evaluated for a Boiling Water Reactor with a Mark I containment. Results from this evaluation include: (1) the identification of plant conditions that would impact instrument performance and information needs during severe accidents; (2) the definition of envelopes of parameters that would be important in assessing the performance of plant instrumentation for a broad range of severe accident sequences; and (3) assessment of the availability of plant instrumentation during severe accidents

  5. Regulatory regime and its influence in the nuclear safety

    International Nuclear Information System (INIS)

    Laaksonen, J.

    1999-01-01

    Main elements of nuclear regulatory regime in general is presented. These elements are: national rules and safety regulations, system of nuclear facility licensing, activities of regulatory body. Regulatory body is needed to specify the national safety regulations, review and assess the safety documentation presented to support license application, make inspections to verify fulfilment of safety regulations and license conditions, monitor the quality of work processes of user organization, and to assess whether these processes provide a high safety level, promote high safety culture, promote maintenance and development of national infrastructure relevant to nuclear safety, etc

  6. Documents preparation and review

    International Nuclear Information System (INIS)

    1999-01-01

    Ignalina Safety Analysis Group takes active role in assisting regulatory body VATESI to prepare various regulatory documents and reviewing safety reports and other documentation presented by Ignalina NPP in the process of licensing of unit 1. The list of main documents prepared and reviewed is presented

  7. 78 FR 44403 - Unified Agenda of Federal Regulatory and Deregulatory Actions

    Science.gov (United States)

    2013-07-23

    ... agenda (the Agenda) in accordance with Public Law 96-354, ``The Regulatory Flexibility Act,'' and... goals; (2) support for the Strategic Plan organizational excellence objectives; (3) a governmental... Flexibility Act Section 610 of the Regulatory Flexibility Act (RFA) requires agencies to conduct a review...

  8. 75 FR 6404 - Regulatory Site Visit Training Program

    Science.gov (United States)

    2010-02-09

    ... review efficiency and quality, and the quality of its regulatory efforts and interactions, by providing... tissue establishments. The visits may include packaging facilities, quality control and pathology...

  9. Review on Cyber Security Programs for NPP Application

    Energy Technology Data Exchange (ETDEWEB)

    Oh, Eung Se [KEPRI, Daejeon (Korea, Republic of)

    2010-10-15

    Increased history records of cyber security (CS) attacks and concerns for computers and networks technical mishaps pull out cyber security to open places. In spite of secrete nature of security, transparent and shared knowledge of many security features are more required at modern plant floors. Korea Institute of Nuclear Safety (KINS), US Government and Nuclear Regulatory Commission (NRC) requested to develop cyber security plans and enforce their implementing to the NPPs. [KINS; CFR; RG 5.71] This paper reviews various cyber security guidelines and suggests an applicable cyber security program development models during the life cycle of NPP's Instrumentation and Control (I and C) systems

  10. Review on Cyber Security Programs for NPP Application

    International Nuclear Information System (INIS)

    Oh, Eung Se

    2010-01-01

    Increased history records of cyber security (CS) attacks and concerns for computers and networks technical mishaps pull out cyber security to open places. In spite of secrete nature of security, transparent and shared knowledge of many security features are more required at modern plant floors. Korea Institute of Nuclear Safety (KINS), US Government and Nuclear Regulatory Commission (NRC) requested to develop cyber security plans and enforce their implementing to the NPPs. [KINS] [CFR] [RG 5.71] This paper reviews various cyber security guidelines and suggests an applicable cyber security program development models during the life cycle of NPP's Instrumentation and Control (I and C) systems

  11. Development approach on usage of radiation and inspection of QA according to the change of approval procedure of safety regulatory guides

    International Nuclear Information System (INIS)

    Oh, B. J.; Ahn, H. Z.; Kim, S. W.; Yoo, S. O.; Kang, S. C.; Yang, S. H.; Han, S. J.; Kim, H. S.; Kim, H. J.

    2002-01-01

    In accordance with 2001 amendment of the Atomic Energy Act(AEA), KINS also amended its internal 'Regulation on Implementation of Entrusted AEA-related Work'. Up to now the nuclear safety-specialized institute has used its internally developed guidelines in the safety regulation. From now on, however, the institute will enhance the objectivity and transparency by having the instruments approved by the Ministry of Science ad Technology. In this paper, we introduced the major points and directions to be considered to the development of the safety regulatory guides on Inspection for the quality assurance of the nuclear reactor facilities and the use of radioisotopes, and review and inspection for dosimeter reading

  12. Modelling the liquidity ratio as macroprudential instrument

    OpenAIRE

    Jan Willem van den End; Mark Kruidhof

    2012-01-01

    The Basel III Liquidity Coverage Ratio (LCR) is a microprudential instrument to strengthen the liquidity position of banks. However, if in extreme scenarios the LCR becomes a binding constraint, the interaction of bank behaviour with the regulatory rule can have negative externalities. We simulate the systemic implications of the LCR by a liquidity stress-testing model, which takes into account the impact of bank reactions on second round feedback effects. We show that a flexible approach of ...

  13. Applying a Developmental Framework to the Self-Regulatory Difficulties of Young Children with Prenatal Alcohol Exposure: A Review.

    Science.gov (United States)

    Reid, Natasha; Petrenko, Christie L M

    2018-06-01

    Prenatal alcohol exposure (PAE) can be associated with significant difficulties in self-regulatory abilities. As such, interventions have been developed that focus on improving varying aspects of self-regulation for this population. The application of a multilevel theoretical framework that describes the development of self-regulation during early childhood could further advance the field. First, this framework could assist in elucidating mechanisms in the trajectories of early adjustment problems in this population and, second, informing the development of more precise assessment and interventions for those affected by PAE. The aims of the current review were to provide an overview of the self-regulatory framework proposed by Calkins and colleagues (e.g., Calkins, 2007; Calkins and Fox, 2002); examine the self-regulatory difficulties that are commonly experienced during infancy (i.e., 0 to 2 years) and early childhood (i.e., 3 to 8 years) in children with PAE in the context of the developmental framework; and describe how the framework can inform the development of future assessment and intervention provision for young children with PAE. The application of a developmental framework, such as proposed by Calkins and colleagues, allows for a systematic and theoretically driven approach to assessment and intervention programs for young children with PAE. Copyright © 2018 by the Research Society on Alcoholism.

  14. The 2007 ESO Instrument Calibration Workshop

    CERN Document Server

    Kaufer, Andreas; ESO Workshop

    2008-01-01

    The 2007 ESO Instrument Calibration workshop brought together more than 120 participants with the objective to a) foster the sharing of information, experience and techniques between observers, instrument developers and instrument operation teams, b) review the actual precision and limitations of the applied instrument calibration plans, and c) collect the current and future requirements by the ESO users. These present proceedings include the majority of the workshop’s contributions and document the status quo of instrument calibration at ESO in large detail. Topics covered are: Optical Spectro-Imagers, Optical Multi-Object Spectrographs, NIR and MIR Spectro-Imagers, High-Resolution Spectrographs, Integral Field Spectrographs, Adaptive Optics Instruments, Polarimetric Instruments, Wide Field Imagers, Interferometric Instruments as well as other crucial aspects such as data flow, quality control, data reduction software and atmospheric effects. It was stated in the workshop that "calibration is a life-long l...

  15. Improving clinical drug development regulatory procedures for anticonvulsants

    Directory of Open Access Journals (Sweden)

    Janković Slobodan

    2015-01-01

    Full Text Available Background: Clinical development of antiepileptic drugs is demanding due to complex character of the disorder and to diversity of its forms and etiologies. Objective: The aim of this review was to suggest improvements in regulatory procedures for clinical development of antiepileptic drugs. Methods: The following databases of scientific articles were searched: MEDLINE, SCOPUS and SCINDEKS. In total 558 publications were retrieved. The types of articles selected were reviews, reports on clinical trials and letters to the Editor. Results: There are several changes of regulatory documents necessary for improving process of clinical development of antiepileptic drugs: preference of parallel groups design for add-on trials should be explicit; the noninferiority design for monotherapy clinical trials should be acceptable; restrictive formulations when trials of antiepileptic drugs in children are in question should be avoided; requirements in regard to the efficacy measures should be harmonized among the regulatory bodies; proactive attitude towards discovery of adverse events; and precise requirements for clinical trials specifically designed to prove anti-epileptogenic effects should be made clear. Conclusion: Current regulatory documents are incomplete in many aspects; an international effort to improve and harmonize guidelines for clinical development of antiepileptic drugs is necessary for improvement of this process.

  16. Regulatory control of nuclear power plants

    International Nuclear Information System (INIS)

    2002-01-01

    The purpose of this book is to support IAEA training courses and workshops in the field of regulatory control of nuclear power plants as well as to support the regulatory bodies of Member States in their own training activities. The target group is the professional staff members of nuclear safety regulatory bodies supervising nuclear power plants and having duties and responsibilities in the following regulatory fields: regulatory framework; regulatory organization; regulatory guidance; licensing and licensing documents; assessment of safety; and regulatory inspection and enforcement. Important topics such as regulatory competence and quality of regulatory work as well as emergency preparedness and public communication are also covered. The book also presents the key issues of nuclear safety such as 'defence-in-depth' and safety culture and explains how these should be taken into account in regulatory work, e.g. during safety assessment and regulatory inspection. The book also reflects how nuclear safety has been developed during the years on the basis of operating experience feedback and results of safety research by giving topical examples. The examples cover development of operating procedures and accident management to cope with complicated incidents and severe accidents to stress the importance of regulatory role in nuclear safety research. The main target group is new staff members of regulatory bodies, but the book also offers good examples for more experienced inspectors to be used as comparison and discussion basis in internal workshops organized by the regulatory bodies for refreshing and continuing training. The book was originally compiled on the basis of presentations provided during the two regulatory control training courses in 1997 and 1998. The textbook was reviewed at the beginning of the years 2000 and 2002 by IAEA staff members and consistency with the latest revisions of safety standards have been ensured. The textbook was completed in the

  17. Optimization criteria for control and instrumentation systems in nuclear power plants

    International Nuclear Information System (INIS)

    Gonzalez, A.J.

    1978-01-01

    The system of dose limitation recently recommended by the International Commission on Radiation Protection includes, as a base for deciding what is reasonably achievable in dose reduction, the optimization of radioprotection systems. This paper, after compiling relevant points in the new system, discusses the application of optimization to control and instrumentation of radioprotection systems in nuclear power plants. Furthermore, an extension of the optimization criterion to nuclear safety systems is also presented and its application to control and instrumentation is discussed; systems including majority logics are particularly scrutinized. Finally, eventual regulatory implications are described. (author)

  18. Regulatory Challenges for Cartilage Repair Technologies.

    Science.gov (United States)

    McGowan, Kevin B; Stiegman, Glenn

    2013-01-01

    In the United States, few Food and Drug Administration (FDA)-approved options exist for the treatment of focal cartilage and osteochondral lesions. Developers of products for cartilage repair face many challenges to obtain marketing approval from the FDA. The objective of this review is to discuss the necessary steps for FDA application and approval for a new cartilage repair product. FDA Guidance Documents, FDA Panel Meetings, scientific organization recommendations, and clinicaltrials.gov were reviewed to demonstrate the current thinking of FDA and the scientific community on the regulatory process for cartilage repair therapies. Cartilage repair therapies can receive market approval from FDA as medical devices, drugs, or biologics, and the specific classification of product can affect the nonclinical, clinical, and regulatory strategy to bring the product to market. Recent FDA guidance gives an outline of the required elements to bring a cartilage repair product to market, although these standards are often very general. As a result, companies have to carefully craft their study patient population, comparator group, and clinical endpoint to best showcase their product's attributes. In addition, regulatory strategy and manufacturing process validation need to be considered early in the clinical study process to allow for timely product approval following the completion of clinical study. Although the path to regulatory approval for a cartilage repair therapy is challenging and time-consuming, proper clinical trial planning and attention to the details can eventually save companies time and money by bringing a product to the market in the most expeditious process possible.

  19. Development of human factors design review guidelines(III)

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jung Woon; Oh, In Suk; Suh, Sang Moon; Lee, Hyun Chul [Korea Atomic Energy Research Institute, Taejon (Korea, Republic of)

    1999-02-15

    The objective of this study is to develop human factors engineering program review guidelines and alarm system review guidelines in order to resolve the two major technical issues: '25, human factors engineering program review model' and '26, review criteria for human factors aspects of advanced controls and instrumentation', which are related to the development of human factors safety regulation guides being performed by KINS. For the development of human factors program review guidelines, we made a Korean version of NUREG-0711 and added our comments by considering Korean regulatory situation and reviewing the reference documents NUREG--0711, additional comments, and selected portion of the reference documents for the developer of safety regulation guides in KINS to see the contents comparatively at a glance and use them easily. For the development of alarm system review guides in KINS to see the contents comparatively at a glance and use them easily. For the development of alarm system review guidelines, we made a Korean version of NUREG/CR-6105, which was published by NRC in 1994 as a guideline document for the human factors review of alarm system. Then we will update the guidelines by reviewing the literature related to alarm design published after 1994.

  20. Development of human factors design review guidelines(III)

    International Nuclear Information System (INIS)

    Lee, Jung Woon; Oh, In Suk; Suh, Sang Moon; Lee, Hyun Chul

    1999-02-01

    The objective of this study is to develop human factors engineering program review guidelines and alarm system review guidelines in order to resolve the two major technical issues: '25, human factors engineering program review model' and '26, review criteria for human factors aspects of advanced controls and instrumentation', which are related to the development of human factors safety regulation guides being performed by KINS. For the development of human factors program review guidelines, we made a Korean version of NUREG-0711 and added our comments by considering Korean regulatory situation and reviewing the reference documents NUREG--0711, additional comments, and selected portion of the reference documents for the developer of safety regulation guides in KINS to see the contents comparatively at a glance and use them easily. For the development of alarm system review guides in KINS to see the contents comparatively at a glance and use them easily. For the development of alarm system review guidelines, we made a Korean version of NUREG/CR-6105, which was published by NRC in 1994 as a guideline document for the human factors review of alarm system. Then we will update the guidelines by reviewing the literature related to alarm design published after 1994

  1. Development of human factors design review guidelines(II)

    International Nuclear Information System (INIS)

    Lee, Jung Woon; Oh, In Suk; Suh, Sang Moon; Lee, Hyun Chul

    1998-06-01

    The objective of this study is to develop human factors engineering program review guidelines and alarm system review guidelines in order to resolve the two major technical issues: '25, human factors engineering program review model' and '26, review criteria for human factors aspects of advanced controls and instrumentation', which are related to the development of human factors safety regulation guides being performed by KINS. For the development of human factors program review guidelines, we made a Korean version of NUREG-0711 and added our comments by considering Korean regulatory situation and reviewing the reference documents NUREG--0711, additional comments, and selected portion of the reference documents for the developer of safety regulation guides in KINS to see the contents comparatively at a glance and use them easily. For the development of alarm system review guides in KINS to see the contents comparatively at a glance and use them easily. For the development of alarm system review guidelines, we made a Korean version of NUREG/CR-6105, which was published by NRC in 1994 as a guideline document for the human factors review of alarm system. Then we will update the guidelines by reviewing the literature related to alarm design published after 1994

  2. Development of human factors design review guidelines(III)

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jung Woon; Oh, In Suk; Suh, Sang Moon; Lee, Hyun Chul [Korea Atomic Energy Research Institute, Taejon (Korea, Republic of)

    1999-02-15

    The objective of this study is to develop human factors engineering program review guidelines and alarm system review guidelines in order to resolve the two major technical issues: '25, human factors engineering program review model' and '26, review criteria for human factors aspects of advanced controls and instrumentation', which are related to the development of human factors safety regulation guides being performed by KINS. For the development of human factors program review guidelines, we made a Korean version of NUREG-0711 and added our comments by considering Korean regulatory situation and reviewing the reference documents NUREG--0711, additional comments, and selected portion of the reference documents for the developer of safety regulation guides in KINS to see the contents comparatively at a glance and use them easily. For the development of alarm system review guides in KINS to see the contents comparatively at a glance and use them easily. For the development of alarm system review guidelines, we made a Korean version of NUREG/CR-6105, which was published by NRC in 1994 as a guideline document for the human factors review of alarm system. Then we will update the guidelines by reviewing the literature related to alarm design published after 1994.

  3. The regulatory infrastructure for radiation protection, the safety of radiation sources and security of radioactive materials in Ethiopia

    International Nuclear Information System (INIS)

    Gebeyehu Wolde, G.

    2003-01-01

    The application of Nuclear Techniques in Ethiopia started in the early sixties in the medical field and through time has gradually expanded to other areas. Following this growth the practice of Radiation Protection in Ethiopia dates back over 15 years. Radiation Protection Legislation 79/1993 was promulgated in December 1993, which has established an Autonomous Regulatory Authority to control and supervise the introduction and conduct of any practice involving ionizing radiation. Since 1998 the National Radiation Protection Authority has made a remarkable progress in terms of building a National Radiation Protection Infrastructure and is in a full swing transformation process towards a dynamic credible and competent regulatory Authority. The regulatory activities are designed in line with the main regulatory instruments, Notification, Authorization, Inspection and Enforcement. NRPA has a national inventory system and fully implemented the Regulatory Authority Information System (RAIS), which provides a systemic integration and will be instrumental to enhance the effectiveness of the regulatory system. A substantial progress has been made in the development and provision of support and technical services in the areas of Metrology and Calibration Services, Instrument Maintenance Service, Individual Monitoring of Personnel, Environmental and Food Monitoring and Interim Storage Facility for spent sources. Development of a national system for emergency preparedness and response is the current top agenda of NRPA. Towards ensuring an effective radiation protection and regulatory programme, NRPA is also making a proactive involvement in, expanding its outreach, information dissemination, awareness promotion and development of key human resources. In the last four years Ethiopia has been actively co-operating with IAEA in the framework of the Regional Model Projects RAF/9/024, RAF/9/028 and RAF/9/029. The inputs received through the project framework coupled with the

  4. New sources and instrumentation for neutrons in biology

    DEFF Research Database (Denmark)

    Teixeira, S. C. M.; Zaccai, G.; Ankner, J.

    2008-01-01

    Neutron radiation offers significant advantages for the study of biological molecular structure and dynamics. A broad and significant effort towards instrumental and methodological development to facilitate biology experiments at neutron sources worldwide is reviewed.......Neutron radiation offers significant advantages for the study of biological molecular structure and dynamics. A broad and significant effort towards instrumental and methodological development to facilitate biology experiments at neutron sources worldwide is reviewed....

  5. Advanced Instrumentation, Information, and Control Systems Technologies Pathway: FY 2016 External Review

    Energy Technology Data Exchange (ETDEWEB)

    Thomas, Kenneth David [Idaho National Lab. (INL), Idaho Falls, ID (United States); Hallbert, Bruce Perry [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2016-11-01

    This report describes an External Review conducted by the LWRS Program Advanced Instrumentation, Information, and Control (II&C) Systems Technologies Pathway to solicit feedback on the topics and results of the ongoing II&C research program. This review was held in conjunction with the Nuclear Energy Institute (NEI) Digital I&C Working Group meeting that was held at Idaho National Laboratory (INL) on August 9-10, 2016. Given the opportunity to visit INL and see the pathway research projects, NEI agreed that the Working Group would serve as the External Review panel for the purpose of obtaining expert input on the value and timing of the research projects. This consisted of demonstrations in the Human Systems Simulation Laboratory followed by presentations on the II&C research program in general as well as the five technology development areas. Following the meeting, the presentations were sent to each of the attendees so they could review them in more detail and refer to them in completing the feedback form. Follow-up activities were conducted with the attendees following the meeting to obtain the completed feedback forms. A total of 13 forms were returned. The feedback forms were reviewed by the pathway to compile the data and comments received, which are documented in the report. In all, the feedback provided by the External Review participants is taken to be a strong endorsement of the types of projects being conducted by the pathway, the value they hold for the nuclear plants, and the general timing of need. The feedback aligns well with the priorities, levels of efforts allocated for the research projects, and project schedules. The feedback also represents realistic observations on the practicality of some aspects of implementing these technologies. In some cases, the participants provided thoughtful challenges to certain assumptions in the formulation of the technologies or in deployment plans. These deserve further review and revision of plans if warranted

  6. Advanced Instrumentation, Information, and Control Systems Technologies Pathway: FY 2016 External Review

    International Nuclear Information System (INIS)

    Thomas, Kenneth David; Hallbert, Bruce Perry

    2016-01-01

    This report describes an External Review conducted by the LWRS Program Advanced Instrumentation, Information, and Control (II&C) Systems Technologies Pathway to solicit feedback on the topics and results of the ongoing II&C research program. This review was held in conjunction with the Nuclear Energy Institute (NEI) Digital I&C Working Group meeting that was held at Idaho National Laboratory (INL) on August 9-10, 2016. Given the opportunity to visit INL and see the pathway research projects, NEI agreed that the Working Group would serve as the External Review panel for the purpose of obtaining expert input on the value and timing of the research projects. This consisted of demonstrations in the Human Systems Simulation Laboratory followed by presentations on the II&C research program in general as well as the five technology development areas. Following the meeting, the presentations were sent to each of the attendees so they could review them in more detail and refer to them in completing the feedback form. Follow-up activities were conducted with the attendees following the meeting to obtain the completed feedback forms. A total of 13 forms were returned. The feedback forms were reviewed by the pathway to compile the data and comments received, which are documented in the report. In all, the feedback provided by the External Review participants is taken to be a strong endorsement of the types of projects being conducted by the pathway, the value they hold for the nuclear plants, and the general timing of need. The feedback aligns well with the priorities, levels of efforts allocated for the research projects, and project schedules. The feedback also represents realistic observations on the practicality of some aspects of implementing these technologies. In some cases, the participants provided thoughtful challenges to certain assumptions in the formulation of the technologies or in deployment plans. These deserve further review and revision of plans if warranted

  7. Cooperation of Ukrainian regulatory authorities in the SIP

    Energy Technology Data Exchange (ETDEWEB)

    Kutina, L.; Bachner, D.; Bykov, V.; Erickson, L.; Kondralyev, S.; Redko, V.; Simonov, I.; Vasilchenko, V. [SSTC NRS, Stusa St. 35-37, 03142, Kyiv (Ukraine)

    2003-07-01

    The State Nuclear Regulatory Committee of Ukraine (SNRCU) supported by the State Scientific and Technical Center (SSTC) and the Licensing consultant (LC - RISKAUDIT/SCIENTECH) coordinates the activities of other regulatory authorities (RA) within the Shelter Implementation Plan (SIP) licensing. A protocol on cooperation and differentiation of competence in the SIP has been agreed between SNRCU and other RA (Ecology, Health, Construction, Occupational safety, Fire). The RA intended to carry out their activities such that SIP be implemented in the most efficient way by: - providing the Chernobyl NPP with a possibility to choose optimal variants for Shelter transformation; - minimizing required regulatory steps for SIP; - reviewing SIP documents at the initial stages of development of SIP designs; - providing consultative support by technical support organizations (TSO) on the SIP designs; - relating regulatory decisions on safety issues to the competence of the inspection at the Chernobyl NPP site. Coordination of regulatory activity and cooperation in safety areas are presented.

  8. A desk evaluation review of project VIE/4/009 design and production of nuclear instruments. Project desk evaluation

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1994-12-09

    A Project Desk Evaluation (PDE) is an intensive review process, using agreed guidelines, of the design, implementation, and the output of a project. This project is exclusively dealing with the design and production of nuclear instruments. The aim of this project would be to develop a viable capability for maintenance and repair of the nuclear instruments at the Dalat Research Institute (DNRI), the premier nuclear centre in Viet Nam, and also to meet the steadily increasing needs of DNRI, as well as of other national institutions, hospitals and universities engaged in the application of nuclear technologies, particularly in the southern part of the country. Project Summary with financial data is given along with training programme. 1 tab.

  9. A desk evaluation review of project VIE/4/009 design and production of nuclear instruments. Project desk evaluation

    International Nuclear Information System (INIS)

    1994-01-01

    A Project Desk Evaluation (PDE) is an intensive review process, using agreed guidelines, of the design, implementation, and the output of a project. This project is exclusively dealing with the design and production of nuclear instruments. The aim of this project would be to develop a viable capability for maintenance and repair of the nuclear instruments at the Dalat Research Institute (DNRI), the premier nuclear centre in Viet Nam, and also to meet the steadily increasing needs of DNRI, as well as of other national institutions, hospitals and universities engaged in the application of nuclear technologies, particularly in the southern part of the country. Project Summary with financial data is given along with training programme. 1 tab

  10. Tritium instrumentation for a fusion reactor power plant

    International Nuclear Information System (INIS)

    Shank, K.E.; Easterly, C.E.

    1976-09-01

    A review of tritium instrumentation is presented. This includes a discussion of currently available in-plant instrumentation and methods required for sampling stacks, monitoring process streams and reactor coolants, analyzing occupational work areas for air and surface contamination, and personnel monitoring. Off-site instrumentation and collection techniques are also presented. Conclusions are made concerning the adequacy of existing instrumentation in relation to the monitoring needs for fusion reactors

  11. Promoting and assessment of safety culture within regulatory body

    International Nuclear Information System (INIS)

    Awasthi, Sumit; Bhattacharya, D.; Koley, J.; Krishnamurthy, P.R.

    2015-01-01

    Regulators have an important role to play in assisting organizations under their jurisdiction to develop positive safety cultures. It is therefore essential for the regulator to have a robust safety culture as an inherent strategy and communication of this strategy to the organizations it supervises. Atomic Energy Regulatory Board (AERB) emphasizes every utility to institute a good safety culture during various stages of a NPP. The regulatory requirement for establishing organisational safety culture within utility at different stages are delineated in the various AERB safety codes which are presented in the paper. Although the review and assessment of the safety culture is a part of AERB’s continual safety supervision through existing review mechanism, AERB do not use any specific indicators for safety culture assessment. However, establishing and nurturing a good safety culture within AERB helps in encouraging the utility to institute the same. At the induction level AERB provides training to its staffs for regulatory orientation which include a specific course on safety culture. Subsequently, the junior staffs are mentored by seniors while involving them in various regulatory processes and putting them as observers during regulatory decision making process. Further, AERB established a formal procedure for assessing and improving safety culture within its staff as a management system process. The paper describes as a case study the above safety culture assessment process established within AERB

  12. US regulatory system for genetically modified [genetically modified organism (GMO), rDNA or transgenic] crop cultivars.

    Science.gov (United States)

    McHughen, Alan; Smyth, Stuart

    2008-01-01

    This paper reviews the history of the federal regulatory oversight of plant agricultural biotechnology in the USA, focusing on the scientific and political forces moulding the continually evolving regulatory structure in place today. Unlike most other jurisdictions, the USA decided to adapt pre-existing legislation to encompass products of biotechnology. In so doing, it established an overarching committee (Office of Science and Technology Policy) to study and distribute various regulatory responsibilities amongst relevant agencies: the Food and Drug Administration, Environmental Protection Agency and US Department of Agriculture. This paper reviews the history and procedures of each agency in the execution of its regulatory duties and investigates the advantages and disadvantages of the US regulatory strategy.

  13. Regulatory control of physical protection systems

    International Nuclear Information System (INIS)

    Rajdeep; Mayya, Y.S.

    2017-01-01

    The safety of facilities in BARC is under the regulatory oversight of BSC. The security architecture for these facilities incorporates multiple layers of Physical Protection Systems. The demands of safety may sometimes conflict with the needs of security. Realizing the need to identify these interfaces and extend the regulatory coverage to Physical Protection Systems, a Standing Committee named Physical Protection System Review Committee (PPSRC) has been constituted as a 2"n"d tier entity of BSC. PPSRC includes experts from various domains concerned with nuclear security, viz. physical protection systems, cyber security, radiation safety, security operations, technical services and security administration

  14. Building Nuclear Safety and Security Culture Within Regulatory Body

    International Nuclear Information System (INIS)

    Huda, K.

    2016-01-01

    To achieve a higher level of nuclear safety and security, it needs to develop the safety and security culture not only in the facility but also in the regulatory body. The regulatory body, especially needs to develop the safety and security culture within the organization, because it has a function to promote and oversee the culture in the facilities. In this sense, the regulatory body should become a role model. Development of the nuclear safety and security culture should be started by properly understanding its concept and awakening the awareness of individual and organization on the importance of nuclear safety and security. For effectiveness of the culture development in the regulatory body, the following steps are suggested to be taken: setting up of the regulatory requirements, self-assessment, independent assessment review, communication with the licensee, oversight of management system implementation, and integration with regulatory activities. The paper discusses those steps in the framework of development of nuclear safety and security culture in the regulatory body, as well as some important elements in building of the culture in the nuclear facilities. (author)

  15. Calibration of solar radiation measuring instruments. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Bahm, R J; Nakos, J C

    1979-11-01

    A review of solar radiation measurement of instruments and some types of errors is given; and procedures for calibrating solar radiation measuring instruments are detailed. An appendix contains a description of various agencies who perform calibration of solar instruments and a description of the methods they used at the time this report was prepared. (WHK)

  16. Steering healthcare service delivery: a regulatory perspective.

    Science.gov (United States)

    Prakash, Gyan

    2015-01-01

    The purpose of this paper is to explore regulation in India's healthcare sector and makes recommendations needed for enhancing the healthcare service. The literature was reviewed to understand healthcare's regulatory context. To understand the current healthcare system, qualitative data were collected from state-level officials, public and private hospital staff. A patient survey was performed to assess service quality (QoS). Regulation plays a central role in driving healthcare QoS. India needs to strengthen market and institutional co-production based approaches for steering its healthcare in which delivery processes are complex and pose different challenges. This study assesses current healthcare regulation in an Indian state and presents a framework for studying and strengthening regulation. Agile regulation should be based on service delivery issues (pull approach) rather than monitoring and sanctions based regulatory environment (push approach). Healthcare pitfalls across the world seem to follow similar follies. India's complexity and experience is useful for emerging and developed economies. The author reviewed around 70 publications and synthesised them in healthcare regulatory contexts. Patient's perception of private providers could be a key input towards steering regulation. Identifying gaps across QoS dimensions would be useful in taking corrective measures.

  17. Transcription regulatory networks analysis using CAGE

    KAUST Repository

    Tegnér, Jesper N.

    2009-10-01

    Mapping out cellular networks in general and transcriptional networks in particular has proved to be a bottle-neck hampering our understanding of biological processes. Integrative approaches fusing computational and experimental technologies for decoding transcriptional networks at a high level of resolution is therefore of uttermost importance. Yet, this is challenging since the control of gene expression in eukaryotes is a complex multi-level process influenced by several epigenetic factors and the fine interplay between regulatory proteins and the promoter structure governing the combinatorial regulation of gene expression. In this chapter we review how the CAGE data can be integrated with other measurements such as expression, physical interactions and computational prediction of regulatory motifs, which together can provide a genome-wide picture of eukaryotic transcriptional regulatory networks at a new level of resolution. © 2010 by Pan Stanford Publishing Pte. Ltd. All rights reserved.

  18. Nuclear Regulatory Commission Information Digest 1992 edition

    International Nuclear Information System (INIS)

    Olive, K.

    1992-03-01

    The Nuclear Regulatory Commission Information Digest provides a summary of information about the US Nuclear Regulatory Commission (NRC), NRC's regulatory responsibilities, the activities NRC licenses, and general information on domestic and worldwide nuclear energy. This digest is a compilation of nuclear- and NRC-related data and is designed to provide a quick reference to major facts about the agency and industry it regulates. In general, the data cover 1975 through 1991, with exceptions noted. Information on generating capacity and average capacity factor for operating US commercial nuclear power reactors is obtained from monthly operating reports that are submitted directly to the NRC by the licensee. This information is reviewed by the NRC for consistency only and no independent validation and/or verification is performed

  19. Challenges in orphan drug development and regulatory policy in China.

    Science.gov (United States)

    Cheng, Alice; Xie, Zhi

    2017-01-18

    While regulatory policy is well defined for orphan drug development in the United States and Europe, rare disease policy in China is still evolving. Many Chinese patients currently pay out of pocket for international treatments that are not yet approved in China. The lack of a clear definition and therefore regulatory approval process for rare diseases has, until now, de-incentivized pharmaceutical companies to pursue rare disease drug development in China. In turn, many grassroots movements have begun to support rare disease patients and facilitate drug discovery through research. Recently, the Chinese FDA set new regulatory guidelines for drugs being developed in China, including an expedited review process for life-saving treatments. In this review, we discuss the effects of these new policy changes on and suggest potential solutions to innovate orphan drug development in China.

  20. Instrumental development and data processing

    International Nuclear Information System (INIS)

    Franzen, J.

    1978-01-01

    A review of recent developments in mass spectrometry instrumentation is presented under the following headings: introduction (scope of mass spectrometry compared with neighbouring fields); ion sources and ionization techniques; spectrometers (instrumental developments); measuring procedures; coupling techniques; data systems; conclusions (that mass spectrometry should have a broader basis and that there would be mutual profit from a better penetration of mass spectrometry into fields of routine application). (U.K.)

  1. The Development and Validation of a Generic Instrument, QoDoS, for Assessing the Quality of Decision Making.

    Science.gov (United States)

    Donelan, Ronan; Walker, Stuart; Salek, Sam

    2016-01-01

    The impact of decision-making during the development and the regulatory review of medicines greatly influences the delivery of new medicinal products. Currently, there is no generic instrument that can be used to assess the quality of decision-making. This study describes the development of the Quality of Decision-Making Orientation Scheme QoDoS(©) instrument for appraising the quality of decision-making. Semi-structured interviews about decision-making were carried out with 29 senior decision makers from the pharmaceutical industry (10), regulatory authorities (9) and contract research organizations (10). The interviews offered a qualified understanding of the subjective decision-making approach, influences, behaviors and other factors that impact such processes for individuals and organizations involved in the delivery of new medicines. Thematic analysis of the transcribed interviews was carried out using NVivo8® software. Content validity was carried out using qualitative and quantitative data by an expert panel, which led to the developmental version of the QoDoS. Further psychometric evaluations were performed, including factor analysis, item reduction, reliability testing and construct validation. The thematic analysis of the interviews yielded a 94-item initial version of the QoDoS(©) with a 5-point Likert scale. The instrument was tested for content validity using a panel of experts for language clarity, completeness, relevance and scaling, resulting in a favorable agreement by panel members with an intra-class correlation coefficient value of 0.89 (95% confidence interval = 0.56, 0.99). A 76-item QoDoS(©) (version 2) emerged from content validation. Factor analysis produced a 47-item measure with four domains. The 47-item QoDoS(©) (version 3) showed high internal consistency (n = 120, Cronbach's alpha = 0.89), high reproducibility (n = 20, intra-class correlation = 0.77) and a mean completion time of 10 min. Reliability testing and construct

  2. 76 FR 8940 - Regulatory Review of Existing DOT Regulations

    Science.gov (United States)

    2011-02-16

    ... interested in comments about factors that the Department should consider in setting priorities and selecting... set forth in our semi-annual Regulatory Agenda published in the Federal Register (see Appendix D to... rulemaking priorities. Moreover, under 49 CFR part 5, anyone may petition the Department for rulemaking or...

  3. Instrumentation requirements for the ESF thermomechanical experiments

    International Nuclear Information System (INIS)

    Pott, J.; Brechtel, C.E.

    1992-01-01

    In situ thermomechanical experiments are planned as part of the Yucca Mountain Site Characterization Project that require instruments to measure stress and displacement at temperatures that exceed the typical specifications of existing geotechnical instruments. A high degree of instrument reliability will also be required to satisfy the objectives of the experiments, therefore a study was undertaken to identify areas where improvement in instrument performance was required. A preliminary list of instruments required for the experiments was developed, based on existing test planning and analysis. Projected temperature requirements were compared to specifications of existing instruments to identify instrumentation development needs. Different instrument technologies, not currently employed in geotechnical instrumentation, were reviewed to identify potential improvements of existing designs for the high temperature environment. Technologies with strong potentials to improve instrument performance with relatively high reliability include graphite fiber composite materials, fiber optics, and video imagery

  4. Economic instruments for environmental policy making in Ontario

    International Nuclear Information System (INIS)

    Barg, S.; Duraiappah, A.; Van Exan, S.

    2000-01-01

    The conditions and approaches required for a successful implementation of economic instruments in Ontario are reviewed. The advantages and disadvantages of economic instruments are discussed, as are some design issues. Some best practices and practical experiences from Canada, the United States, and Europe are examined through the use of nine specific case studies. Each one highlights a different environmental challenge, such as energy efficiency, air pollution, water pollution, waste management along with the solutions that were implemented. The situations described were not all successful, but there is much to be learned from unsuccessful episodes. Lessons learned from the review of the case studies were presented. The points to ponder when using economic instruments in Ontario were highlighted. The command and control policy instrument must be kept in context when considering economic instruments. The reasons that underline the preference of the economic theory for economic instruments are discussed. The different types of economic instruments are described, and the considerations related to the design and comparison of economic instruments is briefly discussed. The authors concluded with several points to ponder: there are a number of options available, details must not be neglected, consultation with the interested parties is important, there is a need for frequent reassessment, and using a number of instruments is helpful. 55 refs., tabs., figs

  5. Control of training instrument

    International Nuclear Information System (INIS)

    Seo, K. W.; Joo, Y. C.; Park, J. C.; Hong, C. S.; Choi, I. K.; Cho, B. J.; Lee, H. Y.; Seo, I. S.; Park, N. K.

    1996-01-01

    This report describes the annual results on control of training instrument. The scope and contents are the following: 1. Control of Compact Nuclear Simulator 2. Control of Radiation/Radioactivity Measurement 3. Control of Non-Destructive Testing Equipment 4. Control of Chemical Equipment 5. Control of Personal Computer 6. Other related Lecture Aid Equipment. Efforts were employed to upgrade the training environment through retrofitting experimental facilities, compiling teaching materials and reforcing audio-visual aids. The Nuclear Training Center executed the open-door training courses for 2,496 engineers/scientists from the nuclear regulatory, nuclear industries, research institutes and other related organizations by means of offering 45 training courses during the fiscal year 1995. (author). 15 tabs., 7 figs., 13 refs

  6. Investigating the Quality of Project-Based Science and Technology Learning Environments in Elementary School: A Critical Review of Instruments

    Science.gov (United States)

    Thys, Miranda; Verschaffel, Lieven; Van Dooren, Wim; Laevers, Ferre

    2016-01-01

    This paper provides a systematic review of instruments that have the potential to measure the quality of project-based science and technology (S&T) learning environments in elementary school. To this end, a comprehensive literature search was undertaken for the large field of S&T learning environments. We conducted a horizontal bottom-up…

  7. Regulatory Flexibility: An Individual Differences Perspective on Coping and Emotion Regulation.

    Science.gov (United States)

    Bonanno, George A; Burton, Charles L

    2013-11-01

    People respond to stressful events in different ways, depending on the event and on the regulatory strategies they choose. Coping and emotion regulation theorists have proposed dynamic models in which these two factors, the person and the situation, interact over time to inform adaptation. In practice, however, researchers have tended to assume that particular regulatory strategies are consistently beneficial or maladaptive. We label this assumption the fallacy of uniform efficacy and contrast it with findings from a number of related literatures that have suggested the emergence of a broader but as yet poorly defined construct that we refer to as regulatory flexibility. In this review, we articulate this broader construct and define both its features and limitations. Specifically, we propose a heuristic individual differences framework and review research on three sequential components of flexibility for which propensities and abilities vary: sensitivity to context, availability of a diverse repertoire of regulatory strategies, and responsiveness to feedback. We consider the methodological limitations of research on each component, review questions that future research on flexibility might address, and consider how the components might relate to each other and to broader conceptualizations about stability and change across persons and situations. © The Author(s) 2013.

  8. Instrumentation availability for a pressurized water reactor with a large dry containment during severe accidents

    International Nuclear Information System (INIS)

    Arcieri, W.C.; Hanson, D.J.

    1991-03-01

    In support of the US Nuclear Regulatory Commission (NRC) Accident Management Research Program, the availability of instruments to supply accident management information during a broad range of severe accidents is evaluated for a pressurized water reactor with a large dry containment. Results from this evaluation include the following: (a) identification of plant conditions that would impact instrument performance and information needs during severe accidents, (b) definition of envelopes of parameters that would be important in assessing the performance of plant instrumentation for a broad range of severe accident sequences, and (c) assessment of the availability of plant instrumentation during severe accidents. 16 refs., 3 figs., 4 tabs

  9. Diagnostic accuracy of portable instrumental devices to measure sleep bruxism: a systematic literature review of polysomnographic studies.

    Science.gov (United States)

    Manfredini, D; Ahlberg, J; Castroflorio, T; Poggio, C E; Guarda-Nardini, L; Lobbezoo, F

    2014-11-01

    This study systematically reviews the sleep bruxism (SB) literature published in the MEDLINE and Scopus databases to answer the following question: What is the validity of the different portable instrumental devices that have been proposed to measure SB if compared with polysomnographic (PSG) recordings assumed as the gold standard? Four clinical studies on humans, assessing the diagnostic accuracy of portable instrumental approaches (i.e. Bitestrip, electromyography (EMG)-telemetry recordings and Bruxoff) with respect to PSG, were included in the review. Methodological shortcomings were identified by QUADAS-2 quality assessment. Findings showed contrasting results and supported only in part the validity of the described diagnostic devices with respect to PSG. The positive predictive value (PPV) of the Bitestrip device was 59-100%, with a sensitivity of 71-84·2%, whilst EMG-telemetry recordings had an unacceptable rate of false-positive findings (76·9%), counterbalanced by an almost perfect sensitivity (98·8%). The Bruxoff device had the highest accuracy values, showing an excellent agreement with PSG for both manual (area under ROC = 0·98) and automatic scoring (0·96) options as well as for the simultaneous recording of events with respect to PSG (0·89-0·91). It can be concluded that the available information on the validity of portable instrumental diagnostic approaches with respect to PSG recordings is still scarce and not solid enough to support any non-PSG technique's employ as a stand-alone diagnostic method in the research setting, with the possible exception of the Bruxoff device that needs to be further confirmed with future investigations. © 2014 John Wiley & Sons Ltd.

  10. Design aspects of safety critical instrumentation of nuclear installations

    Energy Technology Data Exchange (ETDEWEB)

    Swaminathan, P. [Electronics Group, Indira Gandhi Centre for Atomic Research, Kalpakkam 603 102, Tamil Nadu (India)]. E-mail: swamy@igcar.ernet.in

    2005-07-01

    Safety critical instrumentation systems ensure safe shutdown/configuration of the nuclear installation when process status exceeds the safety threshold limits. Design requirements for safety critical instrumentation such as functional and electrical independence, fail-safe design, and architecture to ensure the specified unsafe failure rate and safe failure rate, human machine interface (HMI), etc., are explained with examples. Different fault tolerant architectures like 1/2, 2/2, 2/3 hot stand-by are compared for safety critical instrumentation. For embedded systems, software quality assurance is detailed both during design phase and O and M phase. Different software development models such as waterfall model and spiral model are explained with examples. The error distribution in embedded system is detailed. The usage of formal method is outlined to reduce the specification error. The guidelines for coding of application software are outlined. The interface problems of safety critical instrumentation with sensors, actuators, other computer systems, etc., are detailed with examples. Testability and maintainability shall be taken into account during design phase. Online diagnostics for safety critical instrumentation is detailed with examples. Salient details of design guides from Atomic Energy Regulatory Board, International Atomic Energy Agency and standards from IEEE, BIS are given towards the design of safety critical instrumentation systems. (author)

  11. Design aspects of safety critical instrumentation of nuclear installations

    International Nuclear Information System (INIS)

    Swaminathan, P.

    2005-01-01

    Safety critical instrumentation systems ensure safe shutdown/configuration of the nuclear installation when process status exceeds the safety threshold limits. Design requirements for safety critical instrumentation such as functional and electrical independence, fail-safe design, and architecture to ensure the specified unsafe failure rate and safe failure rate, human machine interface (HMI), etc., are explained with examples. Different fault tolerant architectures like 1/2, 2/2, 2/3 hot stand-by are compared for safety critical instrumentation. For embedded systems, software quality assurance is detailed both during design phase and O and M phase. Different software development models such as waterfall model and spiral model are explained with examples. The error distribution in embedded system is detailed. The usage of formal method is outlined to reduce the specification error. The guidelines for coding of application software are outlined. The interface problems of safety critical instrumentation with sensors, actuators, other computer systems, etc., are detailed with examples. Testability and maintainability shall be taken into account during design phase. Online diagnostics for safety critical instrumentation is detailed with examples. Salient details of design guides from Atomic Energy Regulatory Board, International Atomic Energy Agency and standards from IEEE, BIS are given towards the design of safety critical instrumentation systems. (author)

  12. Advanced Measuring (Instrumentation Methods for Nuclear Installations: A Review

    Directory of Open Access Journals (Sweden)

    Wang Qiu-kuan

    2012-01-01

    Full Text Available The nuclear technology has been widely used in the world. The research of measurement in nuclear installations involves many aspects, such as nuclear reactors, nuclear fuel cycle, safety and security, nuclear accident, after action, analysis, and environmental applications. In last decades, many advanced measuring devices and techniques have been widely applied in nuclear installations. This paper mainly introduces the development of the measuring (instrumentation methods for nuclear installations and the applications of these instruments and methods.

  13. Recognition of Instrumentation Gauge in the Nuclear Power Plant

    Energy Technology Data Exchange (ETDEWEB)

    Cho, Jai Wan; Jeong, Kyung Min [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2015-10-15

    Nuclear emergency robots were developed in 2001 as the countermeasure following the criticality accident at the JCO (uranium refinery facility) in Tokaimura, Japan in 1999. We assumed that these nuclear emergency robots were deployed (or put into) for a mitigation (or management) of severe accident, for example, occurred at Fukushima Daiichi nuclear power plant. In the case, the image understanding using a color CCD camera, loaded on the nuclear emergency robot, is important. We proposed an image processing technique to read indication value of the IC water level gauges using the structural characteristics of the instrumentation panels (water level gauges) located inside the reactor building. At first, we recognized the scales on the instrumentation panel using the geometric shape of the panel. And then, we could read the values of the instrumentation gauge by calculating the slope of the needle on the gauge. Using the proposed algorithm, we deciphered instrumentation panels for the four water level gauges and indicators shown on the IC video released by TEPCO and Japanese Nuclear Regulatory Commission of Japan. In this paper, recognition of the instrumentation gauges inside reactor building of the nuclear power plant by an image processing technology is described.

  14. Surveillance of instruments by noise analysis

    International Nuclear Information System (INIS)

    Thie, J.A.

    1981-01-01

    Random fluctuations of neutron flux, temperature, and pressure in a reactor provide multifrequency excitation of the corresponding instrumentation chains. Mathematical descriptors suitable for characterizing the output, or noise, of the instrumentation are reviewed with a view toward using such noise in detecting instrument faults. Demonstrations of the feasibility of this approach in a number of reactors provide illustrative examples. Comparisons with traditional surveillance testing are made, and a number of advantages and some disadvantages of using noise analysis as a supplementary technique are pointed out

  15. Role of in-house safety analysis and research activities in regulatory decision making

    International Nuclear Information System (INIS)

    Pradhan, Santosh K.; Nagrale, Dhanesh B.; Gaikwad, Avinash J.

    2015-01-01

    Achievement of an acceptable level of nuclear safety is an essential requirement for the peaceful utilization of nuclear energy. The success of Global Nuclear Safety Regime is built upon a foundation of research. Such research has been sponsored by Governments and industry and has led to improved designs, safer and more reliable plant operation, and improvements in operating plant efficiency. A key element of this research has been the nuclear safety research performed or sponsored by regulatory organizations. In part, it has been the safety research performed or sponsored by regulatory organizations that has contributed to improved safety and has laid the foundation for activities such as risk-informed regulation, plant life extension, improved plant performance (e.g. power uprates) and new plant designs. The regulatory research program is meant to improve the regulatory authority’s knowledge where uncertainty exists, where safety margins are not well-characterized, and where regulatory decisions need to be confirmed in existing or new designs and technologies. The regulatory body get research initiated either in-house or by the licensee or through technical support organizations (TSOs). Research and analysis carried out within the regulatory body is of immense value in this context. This could be in the form of analysis of safety significant events, analysis of severe accidents, review of operating experience, independent checks of critical designs and even review of operator responses under different situations towards arriving at modifications to training programmes and licensing procedures for operating personnel. A latent benefit of regulatory research carried out by the regulators themselves is that it improves their technical competence considerably which in turn leads to high quality safety reviews and improved regulation in general. The aim of the present paper is to provide an overview of role of regulatory research and the in-house regulatory safety

  16. Does playing a musical instrument impose a risk for temporomandibular disorders? A review of literature: Stellt das Spielen eines Instruments ein Risiko für kraniomandibuläre Dysfunktionen dar? Eine Übersichtsarbeit

    NARCIS (Netherlands)

    van Selms, M.K.A.; Attallah, M.M.; Visscher, C.M.; Ahlberg, J.; Lobbezoo, F.

    2015-01-01

    Playing a musical instrument that loads the masticatory system, such as the violin or oboe, has been suggested to be part of the group of etiological factors for temporomandibular disorders (TMDs). In 2014, a review of literature was published that explicitly focused on the possible association

  17. RNA SURVEILLANCE– AN EMERGING ROLE FOR RNA REGULATORY NETWORKS IN AGING

    OpenAIRE

    Montano, Monty; Long, Kimberly

    2010-01-01

    In this review, we describe recent advances in the field of RNA regulatory biology and relate these advances to aging science. We introduce a new term, RNA surveillance, an RNA regulatory process that is conserved in metazoans, and describe how RNA surveillance represents molecular cross-talk between two emerging RNA regulatory systems – RNA interference and RNA editing. We discuss how RNA surveillance mechanisms influence mRNA and microRNA expression and activity during lifespan. Additionall...

  18. Results and Insights on the Impact of Smoke on Digital Instrumentation and Control

    Energy Technology Data Exchange (ETDEWEB)

    Tanaka, T. J. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Nowlen, S. P. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2001-01-31

    Smoke can cause interruptions and upsets in active electronics. Because nuclear power plants are replacing analog with digital instrumentation and control systems, qualification guidelines for new systems are being reviewed for severe environments such as smoke and electromagnetic interference. Active digital systems, individual components, and active circuits have been exposed to smoke in a program sponsored by the U.S. Nuclear Regulatory Commission. The circuits and systems were all monitored during the smoke exposure, indicating any immediate effects of the smoke. The major effect of smoke has been to increase leakage currents (through circuit bridging across contacts and leads) and to cause momentary upsets and failures in digital systems. This report summarizes two previous reports and presents new results from conformal coating, memory chip, and hard drive tests. The report describes practices for mitigation of smoke damage through digital system design, fire barriers, ventilation, fire suppressants, and post fire procedures.

  19. STATE INSPECTION METHODOLOGY OF ENVIRONMENTAL REGULATORY ACTIVITY FOCUSED ON THE LIFE CYCLE PROCESSESES

    Directory of Open Access Journals (Sweden)

    Yuniey Quiala Armenteros

    2016-10-01

    Full Text Available The Cuban Environmental Regulatory Activity has on the Environmental State Inspection an instrument for control and monitoring of compliance of current legal standards regarding environmental protection and rational use of natural resources. In this research, a design methodology for effective implementation of environmental regulatory activity in Cuba directed to processes is proposed; based on the life cycle assessment and the applicable environmental management standards, including new performance indicators, which form a new tool based on scientific criterions for the Center of Environmental Inspection and Control.

  20. Regulatory controls for NORM contamination: Emerging issues and strategies

    International Nuclear Information System (INIS)

    Wennerberg, Linda

    1992-01-01

    Naturally occurring and accelerator-produced radioactive material (NORM) faces the increasing likelihood of federal or state regulatory control. Public concern and limited preliminary survey data fuel the debate over the necessity, approach, and jurisdiction of a NORM regulatory strategy. This debate requires the resolution of technical controversies and potentially competing state and federal agency interests. An additional facet of the debate is the impact of regulation upon traditionally non-nuclear industries, such as oil and gas production. Regulatory response has been initiated in several states, such as Louisiana's controls on equipment used in oil and gas production, to control specific industrial activities which generate NORM. A more comprehensive, generic federal strategy to control NORM contamination is also under review by the Environmental Protection Agency. This paper will detail the emerging technical issues, federal and state regulatory strategies under consideration, and evaluate the efficacy of selected regulatory approaches. (author)