Sample records for authorization safety study

  1. 42 CFR 87.4 - For what purposes may grants be awarded?

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH... Safety and Health Act authorizes grants for research, experiments, and demonstrations relating to occupational safety and health, including studies of the psychological factors involved. This authority...

  2. 42 CFR 87.4 - For what purposes may grants be awarded?

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH... Safety and Health Act authorizes grants for research, experiments, and demonstrations relating to occupational safety and health, including studies of the psychological factors involved. This authority...

  3. 42 CFR 87.4 - For what purposes may grants be awarded?

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH... Safety and Health Act authorizes grants for research, experiments, and demonstrations relating to occupational safety and health, including studies of the psychological factors involved. This authority...

  4. Safe Physical Activity Environments--To What Extent Are Local Government Authorities Auditing the Safety of Grassed Sporting Grounds?

    ERIC Educational Resources Information Center

    Otago, Leonie; Swan, Peter; Donaldson, Alex; Payne, Warren; Finch, Caroline

    2009-01-01

    Physical activity (PA) participation is influenced by the safety of the settings in which it is undertaken. This study describes the grounds assessment practices of Local Government Authorities (LGAs) in Victoria, Australia to ensure the safety of grassed sporting grounds. It also makes recommendations for improving these practices to maximise the…

  5. [Safety monitoring of cell-based medicinal products (CBMPs)].

    PubMed

    Funk, Markus B; Frech, Marion; Spranger, Robert; Keller-Stanislawski, Brigitte

    2015-11-01

    Cell-based medicinal products (CBMPs), a category of advanced-therapy medicinal products (ATMPs), are authorised for the European market by the European Commission by means of the centralized marketing authorisation. By conforming to the German Medicinal Products Act (Sec. 4b AMG), national authorisation can be granted by the Paul-Ehrlich-Institut in Germany exclusively for ATMPs not based on a routine manufacturing procedure. In both procedures, quality, efficacy, and safety are evaluated and the risk-benefit balance is assessed. For the centralised procedure, mainly controlled clinical trial data must be submitted, whereas the requirements for national procedures could be modified corresponding to the stage of development of the ATMP. After marketing authorization, the marketing authorization/license holder is obligated to report all serious adverse reactions to the competent authority and to provide periodic safety update reports. If necessary, post-authorization safety studies could be imposed. On the basis of these regulatory measures, the safety of advanced therapies can be monitored and improved.

  6. Note on evaluating safety performance of road infrastructure to motivate safety competition.

    PubMed

    Han, Sangjin

    2016-01-01

    Road infrastructures are usually developed and maintained by governments or public sectors. There is no competitor in the market of their jurisdiction. This monopolic feature discourages road authorities from improving the level of safety with proactive motivation. This study suggests how to apply a principle of competition for roads, in particular by means of performance evaluation. It first discusses why road infrastructure has been slow in safety oriented development and management in respect of its business model. Then it suggests some practical ways of how to promote road safety between road authorities, particularly by evaluating safety performance of road infrastructure. These are summarized as decision of safety performance indicators, classification of spatial boundaries, data collection, evaluation, and reporting. Some consideration points are also discussed to make safety performance evaluation on road infrastructure lead to better road safety management.

  7. Safety Alerts: An Observational Study in Portugal.

    PubMed

    Soares, Sara; Roque, Fátima; Teixeira Rodrigues, António; Figueiras, Adolfo; Herdeiro, Maria Teresa

    2015-09-01

    The information that is available when marketing authorizations are approved is limited. Pharmacovigilance has an important role during the postauthorization period, and alerts published by national authorities allow health care professionals to be informed about new data on safety profiles. This study therefore sought to analyze all safety alerts published by the Portuguese National Authority of Medicines and Health Products I.P. (INFARMED). We conducted an observational study of all alerts published on the INFARMED website from January 2002 through December 2014. From the data included in the alerts, the following information was abstracted: active substance name (and trade name), event that led to the alert, and the resulting safety measures. Active substances were classified according to the Anatomical Therapeutic Chemical (ATC) code. A total of 562 alerts were published, and 304 were eligible for inclusion. The musculoskeletal system was the ATC code with more alerts (n = 53), followed by the nervous system (n = 42). Communication of the information and recommendations to the health care professionals and the public in general was the most frequent safety measure (n = 128), followed by changes in the Summary of the Product Characteristics and package information leaflet (n = 66). During the study period, 26 marketing authorizations were temporarily suspended and 10 were revoked. The knowledge of the alerts published during the postmarketing period is very useful to the health care professionals for improving prescription and use of medicines and to the scientific community for the development of new researches. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

  8. Authorization basis supporting documentation for plutonium finishing plant

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    King, J.P., Fluor Daniel Hanford

    1997-03-05

    The identification and definition of the authorization basis for the Plutonium Finishing Plant (PFP) facility and operations are essential for compliance to DOE Order 5480.21, Unreviewed Safety Questions. The authorization basis, as defined in the Order, consists of those aspects of the facility design basis, i.e., the structures, systems and components (SSCS) and the operational requirements that are considered to be important to the safety of operations and are relied upon by DOE to authorize operation of the facility. These facility design features and their function in various accident scenarios are described in WHC-SD-CP-SAR-021, Plutonium Finishing Plant Final Safety Analysismore » Report (FSAR), Chapter 9, `Accident Analysis.` Figure 1 depicts the relationship of the Authorization Basis to its components and other information contained in safety documentation supporting the Authorization Basis. The PFP SSCs that are important to safety, collectively referred to as the `Safety Envelope` are discussed in various chapters of the FSAR and in WHC-SD-CP-OSR-010, Plutonium Finishing Plant Operational Safety Requirements. Other documents such as Criticality Safety Evaluation Reports (CSERS) address and support some portions of the Authorization Basis and Safety Envelope.« less

  9. Barriers to Safety Event Reporting in an Academic Radiology Department: Authority Gradients and Other Human Factors.

    PubMed

    Siewert, Bettina; Swedeen, Suzanne; Brook, Olga R; Eisenberg, Ronald L; Hochman, Mary

    2018-05-15

    Purpose To investigate barriers to reporting safety concerns in an academic radiology department and to evaluate the role of human factors, including authority gradients, as potential barriers to safety concern reporting. Materials and Methods In this institutional review board-approved, HIPAA-compliant retrospective study, an online questionnaire link was emailed four times to all radiology department staff members (n = 648) at a tertiary care institution. Survey questions included frequency of speaking up about safety concerns, perceived barriers to speaking up, and the annual number of safety concerns that respondents were unsuccessful in reporting. Respondents' sex, role in the department, and length of employment were recorded. Statistical analysis was performed with the Fisher exact test. Results The survey was completed by 363 of the 648 employees (56%). Of those 363 employees, 182 (50%) reported always speaking up about safety concerns, 134 (37%) reported speaking up most of the time, 36 (10%) reported speaking up sometimes, seven (2%) reported rarely speaking up, and four (1%) reported never speaking up. Thus, 50% of employees spoke up about safety concerns less than 100% of the time. The most frequently reported barriers to speaking up included high reporting threshold (69%), reluctance to challenge someone in authority (67%), fear of disrespect (53%), and lack of listening (52%). Conclusion Of employees in a large academic radiology department, 50% do not attain 100% reporting of safety events. The most common human barriers to speaking up are high reporting threshold, reluctance to challenge authority, fear of disrespect, and lack of listening, which suggests that existing authority gradients interfere with full reporting of safety concerns. © RSNA, 2018.

  10. The Impact of Market Orientation on Patient Safety Climate Among Hospital Nurses.

    PubMed

    Weng, Rhay-Hung; Chen, Jung-Chien; Pong, Li-Jung; Chen, Li-Mei; Lin, Tzu-Chi

    2016-03-01

    Improving market orientation and patient safety have become the key concerns of nursing management. For nurses, establishing a patient safety climate is the key to enhancing nursing quality. This study explores how market orientation affects the climate of patient safety among hospital nurses. We proposed adopting a cross-sectional research design and using questionnaires to collect responses from nurses working in two Taiwanese hospitals. Three-hundred and forty-three valid samples were obtained. Multiple regression and path analyses were conducted to test the study. Market orientation was defined as the combination of customer orientation, competitor orientation, and interfunctional coordination. Customer orientation directly affects the climate of patient safety. Although the findings only supported Hypothesis 1, competitor orientation and interfunctional coordination positively affected the patient safety climate through the mediating effects of hospital support for staff. Health care managers could encourage nurses to adopt customer-oriented perspectives to enhance their nursing care. In addition, to enhance competitor orientation, interfunctional coordination, and the patient safety climate, hospital managers could strengthen their support for staff members. © The Author(s) 2014.

  11. Monitoring safety in a phase III real-world effectiveness trial: use of novel methodology in the Salford Lung Study.

    PubMed

    Collier, Sue; Harvey, Catherine; Brewster, Jill; Bakerly, Nawar Diar; Elkhenini, Hanaa F; Stanciu, Roxana; Williams, Claire; Brereton, Jacqui; New, John P; McCrae, John; McCorkindale, Sheila; Leather, David

    2017-03-01

    The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once-daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records. The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in-depth exploration of the safety results will be the subject of future publications. The SLS used a linked database system to capture relevant data from primary care practices in Salford and South Manchester, two university hospitals and other national databases. Patient data were collated and analysed to create daily summaries that were used to alert a specialist safety team to potential safety events. Clinical research teams at participating general practitioner sites and pharmacies also captured safety events during routine consultations. Confidence in the safety monitoring processes over time allowed the methodology to be refined and streamlined without compromising patient safety or the timely collection of data. The information technology infrastructure also allowed additional details of safety information to be collected. Integration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

  12. 10 CFR 35.50 - Training for Radiation Safety Officer.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation... Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user...

  13. 10 CFR 35.50 - Training for Radiation Safety Officer.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation... Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user...

  14. 10 CFR 35.50 - Training for Radiation Safety Officer.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation... Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user...

  15. 10 CFR 35.50 - Training for Radiation Safety Officer.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation... Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user...

  16. Teen worker safety training: methods used, lessons taught, and time spent.

    PubMed

    Zierold, Kristina M

    2015-05-01

    Safety training is strongly endorsed as one way to prevent teens from performing dangerous tasks at work. The objective of this mixed methods study was to characterize the safety training that teenagers receive on the job. From 2010 through 2012, focus groups and a cross-sectional survey were conducted with working teens. The top methods of safety training reported were safety videos (42 percent) and safety lectures (25 percent). The top lessons reported by teens were "how to do my job" and "ways to spot hazards." Males, who were more likely to do dangerous tasks, received less safety training than females. Although most teens are getting safety training, it is inadequate. Lessons addressing safety behaviors are missing, training methods used are minimal, and the time spent is insignificant. More research is needed to understand what training methods and lessons should be used, and the appropriate safety training length for effectively preventing injury in working teens. In addition, more research evaluating the impact of high-quality safety training compared to poor safety training is needed to determine the best training programs for teens. © The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  17. Health Care Worker Fatigue.

    PubMed

    Gardner, Lea Anne; Dubeck, Deborah

    2016-08-01

    The Pennsylvania Patient Safety Reporting System is a confidential, statewide Internet reporting system to which all Pennsylvania hospitals, outpatient-surgery facilities, birthing centers, and abortion facilities must file information on incidents and serious events.Safety Monitor is a column from Pennsylvania's Patient Safety Authority, the authority that informs nurses on issues that can affect patient safety and presents strategies they can easily integrate into practice. For more information on the authority, visit www.patientsafetyauthority.org. For the original article discussed in this column or for other articles on patient safety, click on "Patient Safety Advisories" and then "Advisory Library" in the left-hand navigation menu.

  18. 76 FR 63988 - Pilot Project on NAFTA Trucking Provisions; Pre-Authorization Safety Audits

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

    ...-0097] Pilot Project on NAFTA Trucking Provisions; Pre-Authorization Safety Audits AGENCY: Federal Motor... public comment on data and information concerning the Pre-Authorization Safety Audits (PASAs) for two motor carriers that applied to participate in the Agency's long-haul pilot program to test and...

  19. [Safety of food additives from a German and European point of view].

    PubMed

    Gürtler, R

    2010-06-01

    There are about 300 food additives permitted in the EU for which a re-evaluation program was initiated recently. Occasionally, it is speculated that the use of single food additives might be of safety concern. First results of the re-evaluation could give an impression on how such concerns were taken into account by responsible authorities, such as the European Food Safety Authority (EFSA). For some of the food additives, the lowest dose resulting in adverse effects was lower in recent studies compared to previous studies. Thus, the acceptable daily intake (ADI) derived applying the common uncertainty factor was lower than the ADI derived using data from previous studies. Therefore, it has to be considered whether the conditions of use need to be modified for these food additives.

  20. Statistical issues in the design, conduct and analysis of two large safety studies.

    PubMed

    Gaffney, Michael

    2016-10-01

    The emergence, post approval, of serious medical events, which may be associated with the use of a particular drug or class of drugs, is an important public health and regulatory issue. The best method to address this issue is through a large, rigorously designed safety study. Therefore, it is important to elucidate the statistical issues involved in these large safety studies. Two such studies are PRECISION and EAGLES. PRECISION is the primary focus of this article. PRECISION is a non-inferiority design with a clinically relevant non-inferiority margin. Statistical issues in the design, conduct and analysis of PRECISION are discussed. Quantitative and clinical aspects of the selection of the composite primary endpoint, the determination and role of the non-inferiority margin in a large safety study and the intent-to-treat and modified intent-to-treat analyses in a non-inferiority safety study are shown. Protocol changes that were necessary during the conduct of PRECISION are discussed from a statistical perspective. Issues regarding the complex analysis and interpretation of the results of PRECISION are outlined. EAGLES is presented as a large, rigorously designed safety study when a non-inferiority margin was not able to be determined by a strong clinical/scientific method. In general, when a non-inferiority margin is not able to be determined, the width of the 95% confidence interval is a way to size the study and to assess the cost-benefit of relative trial size. A non-inferiority margin, when able to be determined by a strong scientific method, should be included in a large safety study. Although these studies could not be called "pragmatic," they are examples of best real-world designs to address safety and regulatory concerns. © The Author(s) 2016.

  1. Caring for class III obese patients.

    PubMed

    Gardner, Lea Anne

    2013-11-01

    The Pennsylvania Patient Safety Reporting System is a confidential, statewide Internet reporting system to which all Pennsylvania hospitals, outpatient-surgery facilities, and birthing centers, as well as some abortion facilities, must file information on medical errors.Safety Monitor is a column from Pennsylvania's Patient Safety Authority, the authority that informs nurses on issues that can affect patient safety and presents strategies they can easily integrate into practice. For more information on the authority, visit www.patientsafetyauthority.org. For the original article discussed in this column or for other articles on patient safety, click on "Patient Safety Advisories" and then "Advisory Library" in the left-hand navigation menu.

  2. 2016 Traffic Safety Culture Index

    MedlinePlus

    ... for Traffic Safety. For media inquiries, contact: Tamra Johnson 202-942-2079 TRJohnson@national.aaa.com Authors ... for Traffic Safety. For media inquiries, contact: Tamra Johnson 202-942-2079 TRJohnson@national.aaa.com Authors ...

  3. Professional and Personal Qualities of the Teacher in the Context of the Psychological Safety of Educational Environment

    ERIC Educational Resources Information Center

    Kulikova, Tatyana I.; Maliy, Dmitriy V.

    2017-01-01

    The article deals with the phenomenon of psychological safety of the educational environment (PSEE) in the modern school. Indicators of the educational process participants' psychological safety are revealed. The notion of the teacher's preparedness for the designing activity is defined. The authors have conducted a case study revealing integrated…

  4. The Home Inventory of Dangers and Safety Precautions--2: Addressing Critical Needs for Prescriptive Assessment Devices in Child Maltreatment and in Healthcare.

    ERIC Educational Resources Information Center

    Tymchuk, Alexander J.; Lang, Cathy M.; Doylniuk, Chrystina A.; Berney-Ficklin, Karen; Spitz, Rebecca

    1999-01-01

    Describes a study involving 29 low-income parents with learning difficulties that validated a prescriptive home-danger and safety-precaution instrument containing 14 epidemiological categories to be used in the design and evaluation of family-tailored injury prevention and safety interventions. (Author/CR)

  5. A Comprehensive Approach to Managing School Safety: Case Studies in Catalonia, Spain

    ERIC Educational Resources Information Center

    Díaz-Vicario, Anna; Gairín Sallán, Joaquín

    2017-01-01

    Background: Schools should be safe spaces for students, teaching staff and non-teaching staff. For the concept of "safety" to be meaningful, it must be interpreted broadly to encompass well-being in its widest sense. A common challenge for schools and educational authorities is, therefore, to manage school safety appropriately not only…

  6. New York Metropolitan Transportation Authority safety investigation

    DOT National Transportation Integrated Search

    1993-06-01

    The Federal Transit Administration (FTA) conducted an intensive investigation of passenger and employee safety on the New York Metropolitan Transportation Authority (MTA) and its operating elements. The investigation stressed the system safety concep...

  7. 23 CFR 1200.4 - State Highway Safety Agency-Authority and functions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... is suitably equipped and organized to carry out the State's highway safety program. (b) Authority... safety and projects administered by other State and local agencies; (3) Maintain or have ready access to information contained in State highway safety data systems, including crash, citation, adjudication, emergency...

  8. 23 CFR 1200.4 - State Highway Safety Agency-Authority and functions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... is suitably equipped and organized to carry out the State's highway safety program. (b) Authority... safety and projects administered by other State and local agencies; (3) Maintain or have ready access to information contained in State highway safety data systems, including crash, citation, adjudication, emergency...

  9. 76 FR 52231 - Restrictions on Operators Employing Former Flight Standards Service Aviation Safety Inspectors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-22

    ... Standards Service Aviation Safety Inspectors AGENCY: Federal Aviation Administration (FAA), DOT. ACTION... responsible for the oversight of, a Flight Standards Service Aviation Safety Inspector, and had direct... . SUPPLEMENTARY INFORMATION: Authority for This Rulemaking The FAA's authority to issue rules on aviation safety...

  10. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 35.57 Section 35.57 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...

  11. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ..., teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 35.57 Section 35.57 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...

  12. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ..., teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 35.57 Section 35.57 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...

  13. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ..., teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 35.57 Section 35.57 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...

  14. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 35.57 Section 35.57 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...

  15. Psychological mechanism linking abusive supervision and compulsory citizenship behavior: a moderated mediation study.

    PubMed

    Zhao, Hongdan; Peng, Zhenglong; Han, Yong; Sheard, Geoff; Hudson, Alan

    2013-01-01

    This study seeks to examine the effect of abusive supervision on the "dark side" of organizational citizenship behavior (OCB) and, specifically, compulsory citizenship behavior (CCB). The study focuses on the mediating role of psychological safety underpinning the relationship between abusive supervision and CCB, and the moderating role of Chinese traditionality in influencing the mediation. The authors tested the model with data of 434 dyads (employee-coworker pairs) in a large Chinese service company. Results indicated that psychological safety fully mediated the relationship between abusive supervision and CCB. The authors also found that Chinese traditionality moderated the strength of the mediated relationship between abusive supervision and CCB via psychological safety, such that the mediated relationship is weaker under high Chinese traditionality than under low Chinese traditionality. The article also discusses the implications, limitations, and future research directions.

  16. International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; availability. Notice.

    PubMed

    2010-01-21

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance, which is a revision of an existing guidance, discusses the types of nonclinical studies, their scope and duration, and their relation to the conduct of human clinical trials and marketing authorization for pharmaceuticals. The guidance is intended to facilitate the timely conduct of clinical trials and reduce the unnecessary use of animals and other drug development resources.

  17. Safety Assessment of Talc as Used in Cosmetics.

    PubMed

    Fiume, Monice M; Boyer, Ivan; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

    2015-01-01

    The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of talc for use in cosmetics. The safety of talc has been the subject of much debate through the years, partly because the relationship between talc and asbestos is commonly misunderstood. Industry specifications state that cosmetic-grade talc must contain no detectable fibrous, asbestos minerals. Therefore, the large amount of available animal and clinical data the Panel relied on in assessing the safety of talc only included those studies on talc that did not contain asbestos. The Panel concluded that talc is safe for use in cosmetics in the present practices of use and concentration (some cosmetic products are entirely composed of talc). Talc should not be applied to the skin when the epidermal barrier is missing or significantly disrupted. © The Author(s) 2015.

  18. Maintenance of safety behaviors via response-produced stimuli.

    PubMed

    Angelakis, Ioannis; Austin, Jennifer L

    2015-11-01

    Animal studies suggest that safety behaviors may be maintained by internally or externally produced safety signals, which function as positive reinforcers. We designed two experiments to test this phenomenon with humans. Participants played a computerized game in which they could earn or lose treasures by clicking on a map. In baseline, losses could be postponed by pressing a pedal that also produced a blue bar at the bottom of the screen. During test conditions, no losses were programmed, and pedal presses turned the bar from yellow to blue (Test 1) or blue to yellow (Test 2). In Experiment 2, new participants were exposed to the same conditions but were given information about the safety of the test environment. In both experiments, participants engaged in high rates of pedal pressing when presses were followed by blue bars, suggesting the bar functioned as a safety signal. We discuss how these findings may relate to safety behaviors commonly observed in certain mental health disorders. © The Author(s) 2015.

  19. Stakeholders' Perspectives About and Priorities for Economic Evaluation of Health and Safety Programs in Healthcare.

    PubMed

    Tompa, Emile; de Boer, Henriette; Macdonald, Sara; Alamgir, Hasanat; Koehoorn, Mieke; Guzman, Jaime

    2016-04-01

    This study identified and prioritized resources and outcomes that should be considered in more comprehensive and scientifically rigorous health and safety economic evaluations according to healthcare sector stakeholders. A literature review and stakeholder interviews identified candidate resources and outcomes and then a Delphi panel ranked them. According to the panel, the top five resources were (a) health and safety staff time; (b) training workers; (c) program planning, promotion, and evaluation costs; (d) equipment purchases and upgrades; and (e) administration costs. The top five outcomes were (a) number of injuries, illnesses, and general sickness absences; (b) safety climate; (c) days lost due to injuries, illnesses, and general sickness absences; (d) job satisfaction and engagement; and (e) quality of care and patient safety. These findings emphasize stakeholders' stated priorities and are useful as a benchmark for assessing the quality of health and safety economic evaluations and the comprehensiveness of these findings. © 2016 The Author(s).

  20. Safety assessment of modified terephthalate polymers as used in cosmetics.

    PubMed

    Becker, Lillian C; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

    2014-01-01

    The safety of 6 modified terephthalate polymers as cosmetic ingredients was assessed. These ingredients mostly function as exfoliants, bulking agents, hair fixatives, and viscosity-increasing agents-nonaqueous. Polyethylene terephthalate (PET) is used in leave-on products up to 100% and in rinse-off products up to 2%. The Cosmetic Ingredient Review Expert Panel (Panel) considered that the PET used in cosmetics is chemically equivalent to that used in medical devices. The Panel determined that the Food and Drug Administration's determination of safety of PET in several medical devices, which included human and animal safety data, can be used as the basis for the determination of safety of PET and related polymers used in cosmetics. Use studies of cosmetic eye products that contain PET demonstrated no ocular irritation or dermal sensitization. The Panel concluded that modified terephthalate polymers were safe as cosmetic ingredients in the practices of use and concentration described in this safety assessment. © The Author(s) 2014.

  1. 47 CFR 0.392 - Authority delegated.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 1 2011-10-01 2011-10-01 false Authority delegated. 0.392 Section 0.392 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL COMMISSION ORGANIZATION Delegations of Authority Public Safety and Homeland Security Bureau § 0.392 Authority delegated. The Chief, Public Safety and Homeland...

  2. 47 CFR 0.392 - Authority delegated.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 1 2010-10-01 2010-10-01 false Authority delegated. 0.392 Section 0.392 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL COMMISSION ORGANIZATION Delegations of Authority Public Safety and Homeland Security Bureau § 0.392 Authority delegated. The Chief, Public Safety and Homeland...

  3. Effectiveness of Occupational Health and Safety Training: A Systematic Review with Meta-Analysis

    ERIC Educational Resources Information Center

    Ricci, Federico; Chiesi, Andrea; Bisio, Carlo; Panari, Chiara; Pelosi, Annalisa

    2016-01-01

    Purpose: This meta-analysis aims to verify the efficacy of occupational health and safety (OHS) training in terms of knowledge, attitude and beliefs, behavior and health. Design/methodology/approach: The authors included studies published in English (2007-2014) selected from ten databases. Eligibility criteria were studies concerned with the…

  4. Predictors of Safety Training Transfer Support as In-Role Behavior of Occupational Health and Safety Professionals

    ERIC Educational Resources Information Center

    Freitas, Ana Cristina; Silva, Sílvia Agostinho; Santos, Catarina Marques

    2017-01-01

    Purpose: The purpose of this study is to identify individual and contextual influences on in-house safety trainers' role orientation toward the transfer of training (TT). Design/methodology/approach: The authors tested a model where felt-responsibility for TT mediates the influence of job resources (i.e. autonomy, access to resources, access to…

  5. Effects of outside air temperature on the preparation of antineoplastic drug solutions in biological safety cabinets.

    PubMed

    Umemura, Masayuki; Itoh, Akio; Ando, Yuichi; Yamada, Kiyofumi; Wakiya, Yoshifumi; Nabeshima, Toshitaka

    2015-08-01

    In Japan, biological safety cabinets are commonly used by medical staff to prepare antineoplastic agents. At the Division of Chemotherapy for Outpatients, Nagoya University Hospital, a class II B2 biological safety cabinet is used. The temperature inside this biological safety cabinet decreases in winter. In this study, we investigated the effect of low outside air temperature on the biological safety cabinet temperature, time required to admix antineoplastic agents, and accuracy of epirubicin weight measurement. Studies were conducted from 1 January to 31 March 2008 (winter). The outside air temperature near the biological safety cabinet intake nozzle was compared with the biological safety cabinet temperature. The correlation between the outside air temperature and the biological safety cabinet temperature, time for cyclophosphamide and gemcitabine solubilization, and accuracy of epirubicin weight measurement were investigated at low and high biological safety cabinet temperatures. The biological safety cabinet temperature correlated with the outside air temperature of 5-20℃ (p < 0.0001). Compared to cyclophosphamide and gemcitabine solubilization in the biological safety cabinet at 25℃, solubilization at 10℃ was significantly delayed (p < 0.01 and p < 0.0001, respectively). Measurement of epirubicin weight by using a syringe lacked accuracy because of epirubicin's high viscosity at low temperatures (p < 0.01). These results suggest that the biological safety cabinet temperature decreases when cool winter air is drawn into the biological safety cabinet, affecting the solubilization of antineoplastic agents. We suggest that a decrease in biological safety cabinet temperature may increase the time required to admix antineoplastic agents, thereby increasing the time for which outpatients must wait for chemotherapy. © The Author(s) 2014.

  6. A study on current risk assessments and guidelines on the use of food animal products derived from cloned animals.

    PubMed

    Hur, Sun Jin

    2017-10-01

    The author widely surveyed and analyzed the food safety issues, ethical issues, permits, and approval of animal products from animals cloned by somatic cell nuclear transfer worldwide. As a result of a 2-year survey, the author found that there is no evidence that meat and milk derived from cloned animals or their progeny pose a risk to food safety in terms of genotoxicity, adverse reproductive effects, or allergic reactions. Most countries have not approved meat and milk derived from cloned animals, and their progeny are entering the food supply. To establish the guidelines, the author suggests four principles of safety assessment for meat and milk derived from cloned animals. The four main principles for safety assessment are similarities of chemical composition, adverse reproductive effects, genotoxicity, and allergic reactions under the influence of meat and milk from cloned animals and noncloned counterparts. This principle means that meat and milk derived from a cloned animal are safe if there are no differences in the four safety assessments of meat and milk between cloned animal's progeny and noncloned counterparts. Copyright © 2017 Elsevier Ltd. All rights reserved.

  7. 29 CFR 1952.365 - Level of Federal enforcement.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... Mexico occupational health and safety plan, discretionary Federal enforcement authority under section 18... authority fully or effectively; (7) Enforcement of occupational safety and health standards at all Federal...

  8. 77 FR 62466 - Airworthiness Directives; GA200 (Pty) Ltd Airplanes

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-15

    ... Aviation Safety Authority (CASA), which is the aviation authority for the Commonwealth of Australia, has...) Related Information Refer to MCAI Civil Aviation Safety Authority (CASA) AD AD/ GA200/1, Amendment 1...

  9. 78 FR 28897 - Tennessee Valley Authority; Establishment of Atomic Safety and Licensing Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-16

    ...] Tennessee Valley Authority; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by the... CFR 2.104, 2.105, 2.300, 2.309, 2.313, 2.318, and 2.321, notice is hereby given that an Atomic Safety... comprised of the following administrative judges: Alex S. Karlin, Chairman, Atomic Safety and Licensing...

  10. Safety of Novel Microbes for Human Consumption: Practical Examples of Assessment in the European Union

    PubMed Central

    Brodmann, Theodor; Endo, Akihito; Gueimonde, Miguel; Vinderola, Gabriel; Kneifel, Wolfgang; de Vos, Willem M.; Salminen, Seppo; Gómez-Gallego, Carlos

    2017-01-01

    Novel microbes are either newly isolated genera and species from natural sources or bacterial strains derived from existing bacteria. Novel microbes are gaining increasing attention for the general aims to preserve and modify foods and to modulate gut microbiota. The use of novel microbes to improve health outcomes is of particular interest because growing evidence points to the importance of gut microbiota in human health. As well, some recently isolated microorganisms have promise for use as probiotics, although in-depth assessment of their safety is necessary. Recent examples of microorganisms calling for more detailed evaluation include Bacteroides xylanisolvens, Akkermansia muciniphila, fructophilic lactic acid bacteria (FLAB), and Faecalibacterium prausnitzii. This paper discusses each candidate's safety evaluation for novel food or novel food ingredient approval according to European Union (EU) regulations. The factors evaluated include their beneficial properties, antibiotic resistance profiling, history of safe use (if available), publication of the genomic sequence, toxicological studies in agreement with novel food regulations, and the qualified presumptions of safety. Sufficient evidences have made possible to support and authorize the use of heat-inactivated B. xylanisolvens in the European Union. In the case of A. muciniphila, the discussion focuses on earlier safety studies and the strain's suitability. FLAB are also subjected to standard safety assessments, which, along with their proximity to lactic acid bacteria generally considered to be safe, may lead to novel food authorization in the future. Further research with F. prausnitzii will increase knowledge about its safety and probiotic properties and may lead to its future use as novel food. Upcoming changes in EUU Regulation 2015/2283 on novel food will facilitate the authorization of future novel products and might increase the presence of novel microbes in the food market. PMID:28955311

  11. Assessment of Battery Technology for Rail Propulsion Application

    DOT National Transportation Integrated Search

    2017-08-01

    The study's authors conducted a review of various battery chemistries, including information on basic electrochemistry and the critical parameters that drive battery design and sizing. The authors examined the performance, life cycle, and safety of l...

  12. Charcoal and charcoal-based dentifrices: A literature review.

    PubMed

    Brooks, John K; Bashirelahi, Nasir; Reynolds, Mark A

    2017-09-01

    Sales of charcoal dentifrices and powders have rapidly emerged into the Internet marketplace. The authors conducted a literature review to examine the efficacy and safety of charcoal and charcoal-based dentifrices. The authors searched the MEDLINE and Scopus databases for clinical studies on the use of charcoal and charcoal-based dentifrices and laboratory investigations on the bioactivity or toxicity of charcoal and charcoal-based dentifrices, published through February 2017. The authors used a defined search strategy to identify randomized, controlled clinical trials with a follow-up duration of 3 months or longer. In addition, the authors selected the first 50 consecutive charcoal dentifrices from Google.com and Amazon.com for ascertainment of product assortment and advertising promotions. The authors' literature search identified 118 potentially eligible articles. Thirteen studies reported brushing the teeth with raw charcoal or soot; however, none of these studies met the inclusion criteria. Two studies offered nonspecific caries reductions, 3 studies reported deleterious outcomes (increased caries, enamel abrasion, nonquantified negative impact), and 1 study indicated only that brushing with raw charcoal had no adverse effects on oral hygiene. Seven other studies reported only on the use of charcoal for oral hygiene. Internet advertisements included unsubstantiated therapeutic claims-such as antibacterial, antifungal, antiviral, and oral detoxification, as well as potentially misleading product assertions. One-third of the charcoal dentifrices contained bentonite clay, and 1 contained betel leaves. The results of this literature review showed insufficient clinical and laboratory data to substantiate the safety and efficacy claims of charcoal and charcoal-based dentifrices. Larger-scale and well-designed studies are needed to establish conclusive evidence. Dental clinicians should advise their patients to be cautious when using charcoal and charcoal-based dentifrices with unproven claims of efficacy and safety. Copyright © 2017 American Dental Association. Published by Elsevier Inc. All rights reserved.

  13. Neighbourhood social trust and youth perceptions of safety during daily activities.

    PubMed

    Flynn, Kalen; Richmond, Therese S; Branas, Charles C; Wiebe, Douglas J

    2017-10-07

    Exposure to adverse neighbourhood conditions can negatively impact adolescent well-being and perceived safety. However, the impact of neighbourhood social trust on perceived safety is largely unknown. We studied 139 adolescent men to investigate how their perceptions of safety varied as a function of social trust levels in the neighbourhoods they traversed; neighbourhoods that were not necessarily their own. Adolescents mapped their minute-by-minute activities over a recent day and rated their perceived safety on a 10-point scale during in-person interviews. Neighbourhood social trust was measured via a citywide random sample survey. Mixed effects regression showed that, compared with their safety perceptions when in areas of low social trust, older adolescents were 73% more likely to feel unsafe when in areas of medium social trust, and 89% more likely to feel unsafe when in areas of high social trust. Inverse relationships between neighbourhood social trust and adolescents' perceived safety highlight the complex interplay between youth, environmental contexts and safety. © 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.

  14. 75 FR 3471 - International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0470... Human Clinical Trials and Marketing Authorization for Pharmaceuticals; Availability AGENCY: Food and... the availability of a guidance entitled ``M3(R2) Nonclinical Safety Studies for the Conduct of Human...

  15. Tritium safety study using Caisson Assembly (CATS) at TPL/JAEA

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Hayashi, T.; Kobayashi, K.; Iwai, Y.

    Tritium confinement is required as the most important safety Junction for a fusion reactor. In order to demonstrate the confinement performance experimentally, an unique equipment, called CATS: Caisson Assembly for Tritium Safety study, was installed in Tritium Process Laboratory of Japan Atomic Energy Agency and operated for about 10 years. Tritium confinement and migration data in CATS have been accumulated and dynamic simulation code was accumulated using these data. Contamination and decontamination behavior on various materials and new safety equipment functions have been investigated under collaborations with a lot of laboratories and universities. (authors)

  16. Identifying research priorities for patient safety in mental health: an international expert Delphi study.

    PubMed

    Dewa, Lindsay H; Murray, Kevin; Thibaut, Bethan; Ramtale, Sonny Christian; Adam, Sheila; Darzi, Ara; Archer, Stephanie

    2018-03-03

    Physical healthcare has dominated the patient safety field; research in mental healthcare is not as extensive but findings from physical healthcare cannot be applied to mental healthcare because it delivers specialised care that faces unique challenges. Therefore, a clearer focus and recognition of patient safety in mental health as a distinct research area is still needed. The study aim is to identify future research priorities in the field of patient safety in mental health. Semistructured interviews were conducted with the experts to ascertain their views on research priorities in patient safety in mental health. A three-round online Delphi study was used to ascertain consensus on 117 research priority statements. Academic and service user experts from the USA, UK, Switzerland, Netherlands, Ireland, Denmark, Finland, Germany, Sweden, Australia, New Zealand and Singapore were included. Agreement in research priorities on a five-point scale. Seventy-nine statements achieved consensus (>70%). Three out of the top six research priorities were patient driven; experts agreed that understanding the patient perspective on safety planning, on self-harm and on medication was important. This is the first international Delphi study to identify research priorities in safety in the mental field as determined by expert academic and service user perspectives. A reasonable consensus was obtained from international perspectives on future research priorities in patient safety in mental health; however, the patient perspective on their mental healthcare is a priority. The research agenda for patient safety in mental health identified here should be informed by patient safety science more broadly and used to further establish this area as a priority in its own right. The safety of mental health patients must have parity with that of physical health patients to achieve this. © 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 expressly granted.

  17. Influence of the dietary supplement health and education act on consumer beliefs about the safety and effectiveness of dietary supplements.

    PubMed

    Dodge, Tonya; Litt, Dana; Kaufman, Annette

    2011-03-01

    The authors conducted two studies to examine the influence of the U.S. Dietary Supplement Health and Education Act (DSHEA) on consumer beliefs about the safety and effectiveness of dietary supplements. Study 1 manipulated information about Food and Drug Administration (FDA) approval in the context of a dietary supplement designed to improve immune system functioning. Study 2 tested the effect of an educational intervention designed to improve knowledge about the DSHEA. Results of Study 1 highlighted deficits in consumer knowledge about FDA regulation of dietary supplements. Results also showed that information about FDA approval failed to have a statistically significant effect on beliefs about safety or effectiveness of the dietary supplement. Results of Study 2 showed that participants who were educated about the regulation of dietary supplements under the DSHEA rated dietary supplements as less safe and less effective than did participants in the control condition. The authors discuss the implications for consumers in the United States and for public policy.

  18. Liquefied natural gas (LNG) safety

    NASA Technical Reports Server (NTRS)

    Ordin, P. M.

    1977-01-01

    Bibliography, assembled from computer search of NASA Aerospace Safety Data Bank, including title of report, author, abstract, source, description of figures, key references, and key words or subject terms. Publication is indexed by key subjects and by authors. Items are relevant to design engineers and safety specialists.

  19. What stage are low-income and middle-income countries (LMICs) at with patient safety curriculum implementation and what are the barriers to implementation? A two-stage cross-sectional study.

    PubMed

    Ginsburg, Liane R; Dhingra-Kumar, Neelam; Donaldson, Liam J

    2017-06-15

    The improvement of safety in healthcare worldwide depends in part on the knowledge, skills and attitudes of staff providing care. Greater patient safety content in health professional education and training programmes has been advocated internationally. While WHO Patient Safety Curriculum Guides (for Medical Schools and Multi-Professional Curricula) have been widely disseminated in low-income and middle-income countries (LMICs) over the last several years, little is known about patient safety curriculum implementation beyond high-income countries. The present study examines patient safety curriculum implementation in LMICs. Two cross-sectional surveys were carried out. First, 88 technical officers in Ministries of Health and WHO country offices were surveyed to identify the pattern of patient safety curricula at country level. A second survey followed that gathered information from 71 people in a position to provide institution-level perspectives on patient safety curriculum implementation. The majority, 69% (30/44), of the countries were either considering whether to implement a patient safety curriculum or actively planning, rather than actually implementing, or embedding one. Most organisations recognised the need for patient safety education and training and felt a safety curriculum was compatible with the values of their organisation; however, important faculty-level barriers to patient safety curriculum implementation were identified. Key structural markers, such as dedicated financial resources and relevant assessment tools to evaluate trainees' patient safety knowledge and skills, were in place in fewer than half of organisations studied. Greater attention to patient safety curriculum implementation is needed. The barriers to patient safety curriculum implementation we identified in LMICs are not unique to these regions. We propose a framework to act as a global standard for patient safety curriculum implementation. Educating leaders through the system in order to embed patient safety culture in education and clinical settings is a critical first step. © 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.

  20. Alcohol abuse and traffic safety : a study of fatalities, DWI offenders, alcoholics, and court-related treatment approaches

    DOT National Transportation Integrated Search

    1970-06-26

    Author's abstract: Methodology and conclusions on the role of the abusive use of alcohol in traffic safety were developed through three related projects. Project I is a case-history investigation of 616 traffic fatalities from metropolitan Wayne Coun...

  1. Regulatory forum opinion piece*: supporting the need for international harmonization of safety assessments for food flavoring substances.

    PubMed

    Konishi, Yoichi; Hayashi, Shim-Mo; Fukushima, Shoji

    2014-08-01

    The advancement of technology and the growth of international commerce underscore the need for global harmonization of regulatory safety requirements and their assessment pertaining to consumer products such as drugs, medical devices, and food. This need is particularly relevant when safety requirements involve time-intensive and costly animal safety studies. Here we present the current regulatory requirements in Europe, the United States, and Japan for flavoring substances (FSs) used in foods and point out significant differences relevant to the international standardization for safety assessments that in our opinion need to be addressed and overcome. The safety assessments that are carried out for FSs in various countries are influenced by divergent definitions of FS, by the information required and available for regulatory submission, and by different regulatory procedures, including the use of decision tree approaches. The European Food Safety Authority (EFSA), the Expert Panel of the U.S. Flavor and Extract Manufacturers Association (FEMA), and the Joint Food and Agriculture Organization (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) are making efforts to improve and harmonize the safety assessment of FSs. The application of in silico methods such as quantitative structure-activity relationships and read-across strategies relying on expert input are useful as a first-step screening of the assessment. Application of the Threshold of Toxicological Concern (TTC) approach permits conclusions that are compatible with the risk assessment approaches currently used by international advisory committees. The Japanese Regulatory Authority, on the other hand, does not yet consider in silico methods but still requires in vivo and in vitro genotoxicity test data as well as repeat-dose 90-day toxicity data in at least one species, to be submitted as the first step in the safety assessment of FSs. With this article, we echo requests that have been made for xenobiotics by the pharmaceutical industry worldwide, extending them to food-related products, especially FSs. We encourage regulatory agencies to adopt globally harmonized safety assessment procedures, regulatory guidelines, and review practices for FSs to foster global trade and to reduce costs and laboratory animal use. © 2013 by The Author(s).

  2. Nonclinical safety of the sodium-glucose cotransporter 2 inhibitor empagliflozin.

    PubMed

    Bogdanffy, Matthew S; Stachlewitz, Robert F; van Tongeren, Susan; Knight, Brian; Sharp, Dale E; Ku, Warren; Hart, Susan Emeigh; Blanchard, Kerry

    2014-01-01

    Empagliflozin, a selective inhibitor of the renal tubular sodium-glucose cotransporter 2, was developed for treatment of type 2 diabetes mellitus. Nonclinical safety of empagliflozin was studied in a battery of tests to support global market authorization. Safety pharmacology studies indicated no effect of empagliflozin on measures of respiratory or central nervous system function in rats or cardiovascular safety in telemeterized dogs. In CD-1 mouse, Wistar Han rat, or beagle dogs up to 13, 26, or 52 weeks of treatment, respectively, empagliflozin exhibited a toxicity profile consistent with secondary supratherapeutic pharmacology related to glucose loss and included decreased body weight and body fat, increased food consumption, diarrhea, dehydration, decreased serum glucose and increases in other serum parameters reflective of increased protein catabolism, gluconeogenesis, and electrolyte imbalances, and urinary changes such as polyuria and glucosuria. Microscopic changes were consistently observed in kidney and included tubular nephropathy and interstitial nephritis (dog), renal mineralization (rat) and tubular epithelial cell karyomegaly, single cell necrosis, cystic hyperplasia, and hypertrophy (mouse). Empagliflozin was not genotoxic. Empagliflozin was not carcinogenic in female mice or female rats. Renal adenoma and carcinoma were induced in male mice only at exposures 45 times the maximum clinical dose. These tumors were associated with a spectrum of nonneoplastic changes suggestive of a nongenotoxic, cytotoxic, and cellular proliferation-driven mechanism. In male rats, testicular interstitial cell tumors and hemangiomas of the mesenteric lymph node were observed; both tumors are common in rats and are unlikely to be relevant to humans. These studies demonstrate the nonclinical safety of empagliflozin. © The Author(s) 2014.

  3. Safety equipment list for the 241-SY-101 RAPID mitigation project

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    MORRIS, K.L.

    1999-06-29

    This document provides the safety classification for the safety (safety class and safety RAPID Mitigation Project. This document is being issued as the project SEL until the supporting authorization basis documentation, this document will be superseded by the TWRS SEL (LMHC 1999), documentation istlralized. Upon implementation of the authorization basis significant) structures, systems, and components (SSCS) associated with the 241-SY-1O1 which will be updated to include the information contained herein.

  4. The Use of Minipigs for Preclinical Safety Assessment by the Pharmaceutical Industry: Results of an IQ DruSafe Minipig Survey.

    PubMed

    Colleton, Curtis; Brewster, David; Chester, Anne; Clarke, David O; Heining, Peter; Olaharski, Andrew; Graziano, Michael

    2016-04-01

    The use of minipigs in preclinical safety testing of pharmaceuticals is considered an alternative to the more traditional dog and nonhuman primate (NHP) nonrodent species. Substantial evidence exists to suggest that the anatomy, physiology, and biochemistry of minipigs are similar enough to humans to consider them as valid nonrodent models for pharmaceutical safety testing. Since the utilization of minipigs was last assessed over 5 years ago, the Preclinical Safety Leadership Group (DruSafe) of the International Consortium for Innovation and Quality in Pharmaceutical Development conducted this survey to provide an updated assessment of the utility, perceived value, and impediments to the use of minipigs in preclinical safety testing. Of the 32 participating members of DruSafe, 15 responded to the survey representing both large and small companies. Respondents indicated that the minipig has been utilized mostly for short-term safety assessment studies with dermal, oral, and parenteral routes of administration. Minipigs are widely accepted as appropriate models for cardiovascular assessments and have been used to a limited extent for reproductive toxicology testing. Overall responses indicated that safety testing for large molecules using this species is relatively low due to a lack of background data, reagents or biomarkers, concerns regarding immune system characterization and poor suitability for developmental toxicity assessments. Most companies utilized contract research organizations for definitive safety toxicity assessment studies. Conclusions of this survey indicate that minipig is an acceptable nonrodent species largely limited to studies using small molecules, primarily dermal products, and results are comparable to those reported 5 years ago. © The Author(s) 2016.

  5. Identifying patient and practice characteristics associated with patient-reported experiences of safety problems and harm: a cross-sectional study using a multilevel modelling approach.

    PubMed

    Ricci-Cabello, Ignacio; Reeves, David; Bell, Brian G; Valderas, Jose M

    2017-11-01

    To identify patient and family practice characteristics associated with patient-reported experiences of safety problems and harm. Cross-sectional study combining data from the individual postal administration of the validated Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) questionnaire to a random sample of patients in family practices (response rate=18.4%) and practice-level data for those practices obtained from NHS Digital. We built linear multilevel multivariate regression models to model the association between patient-level (clinical and sociodemographic) and practice-level (size and case-mix, human resources, indicators of quality and safety of care, and practice safety activation) characteristics, and outcome measures. Practices distributed across five regions in the North, Centre and South of England. 1190 patients registered in 45 practices purposefully sampled (maximal variation in practice size and levels of deprivation). Self-reported safety problems, harm and overall perception of safety. Higher self-reported levels of safety problems were associated with younger age of patients (beta coefficient 0.15) and lower levels of practice safety activation (0.44). Higher self-reported levels of harm were associated with younger age (0.13) and worse self-reported health status (0.23). Lower self-reported healthcare safety was associated with lower levels of practice safety activation (0.40). The fully adjusted models explained 4.5% of the variance in experiences of safety problems, 8.6% of the variance in harm and 4.4% of the variance in perceptions of patient safety. Practices' safety activation levels and patients' age and health status are associated with patient-reported safety outcomes in English family practices. The development of interventions aimed at improving patient safety outcomes would benefit from focusing on the identified groups. © 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.

  6. Index to Nuclear Safety. A technical progress review by chronology, permuted title, and author. Vol. 11, No. 1--Vol. 17, No. 6

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Cottrell, W.B.; Klein, A.

    1977-02-23

    This index to Nuclear Safety covers articles in Nuclear Safety Vol. 11, No. 1 (Jan.-Feb. 1970), through Vol. 17, No. 6 (Nov.-Dec. 1976). The index includes a chronological list of articles (including abstract) followed by KWIC and Author Indexes. Nuclear Safety, a bimonthly technical progress review prepared by the Nuclear Safety Information Center, covers all safety aspects of nuclear power reactors and associated facilities. The index lists over 350 technical articles in the last six years of publication.

  7. A Step Towards Improving Food Safety in India: Determining Baseline Knowledge and Behaviors Among Restaurant Food Handlers in Chennai.

    PubMed

    Manes, Mindi R; Kuganantham, Paraswami; Jagadeesan, Murugesan; Laxmidevi, M; Dworkin, Mark S

    2016-01-01

    With the establishment of the Food Safety and Standards Authority of India (FSSAI) and new food safety regulations, a precedent has been set to prevent foodborne illness in India. The objective of the authors' study was to identify knowledge gaps among food handlers in Chennai, Tamil Nadu, to establish priorities for future intervention. A 44-question survey was administered to 156 food handlers at 36 restaurants in Chennai between April and June of 2011. The overall mean knowledge score was 49% and knowledge gaps related to hand hygiene, proper food cooking and holding temperatures, and cross contamination were identified. Food handlers with a Medical Fitness Certificate scored significantly higher than those without a certificate, after controlling for food safety training and level of education (p < .05). As the FSSAI standards now require a medical certificate for restaurant licensure and registration, consideration should be given to include an educational component to this certification with an explanation of expected food safety behavior.

  8. Cost-effectiveness analysis: what it really means for transfusion medicine decision making.

    PubMed

    Custer, Brian; Hoch, Jeffrey S

    2009-01-01

    Some have suggested that "blood is different," and the role for cost-effectiveness is thus circumscribed. In this article, the authors start by reviewing key concepts in health economics and economic analysis methods. Examples are drawn from published blood safety studies. After explaining the underlying reasoning behind cost-effectiveness analysis, the authors point out how economic thinking is evident in some aspects of transfusion medicine. Some cost-effectiveness study results for blood safety are discussed to provide context, followed by consideration of prominent decisions that have been made in transfusion medicine field. In the last section, the authors conjecture as to why in some cases cost-effectiveness analysis appears to have greater impact than in others, noting the terrible price that is paid in mortality and morbidity when cost-effectiveness analysis is ignored. In this context, the implications of opportunity cost are discussed, and it is noted that opportunity cost should not be viewed as benefits forgone by concentrating on one aspect of blood safety and instead should be viewed as our societal willingness to misallocate resources to achieve less health for the same cost.

  9. A baseline assessment of emergency planning and preparedness in Italian universities.

    PubMed

    Marincioni, Fausto; Fraboni, Rita

    2012-04-01

    Besides offering teaching and research services, schools and universities also must provide for the safety and security of their employees, students, and visitors. This paper describes emergency preparedness in a sample of Italian universities. In particular it examines risk perception within a specific professional category (university safety and security officers) in a specific cultural context (Italy). In addition, it discusses the transposition and implementation in a European Union (EU) member state of EU Council Directive 89/391/EEC of 12 June 1989, on the introduction of measures to encourage improvements in the safety and health of workers. The findings highlight heterogeneous and fragmented emergency management models within the Italian university system, underlining the need for a stricter framework of standardised safety protocols and emergency management guidelines. The study also points out that enhancing emergency planning and preparedness in Italian universities entails increasing safety leadership, employee engagement and individual responsibility for safety and security; essentially, it necessitates improving the culture of risk prevention. © 2012 The Author(s). Disasters © Overseas Development Institute, 2012.

  10. Method of operator safety assessment for underground mobile mining equipment

    NASA Astrophysics Data System (ADS)

    Działak, Paulina; Karliński, Jacek; Rusiński, Eugeniusz

    2018-01-01

    The paper presents a method of assessing the safety of operators of mobile mining equipment (MME), which is adapted to current and future geological and mining conditions. The authors focused on underground mines, with special consideration of copper mines (KGHM). As extraction reaches into deeper layers of the deposit it can activate natural hazards, which, thus far, have been considered unusual and whose range and intensity are different depending on the field of operation. One of the main hazards that affect work safety and can become the main barrier in the exploitation of deposits at greater depths is climate threat. The authors have analysed the phenomena which may impact the safety of MME operators, with consideration of accidents that have not yet been studied and are not covered by the current safety standards for this group of miners. An attempt was made to develop a method for assessing the safety of MME operators, which takes into account the mentioned natural hazards and which is adapted to current and future environmental conditions in underground mines.

  11. Pharmacovigilance in pharmaceutical companies: An overview

    PubMed Central

    Mammì, Maria; Citraro, Rita; Torcasio, Giovanni; Cusato, Gennaro; Palleria, Caterina; di Paola, Eugenio Donato

    2013-01-01

    Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use and during clinical trials. In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products for human use. Regulation (EU) No 1235/2010 and Directive 2010/84/EU introduced new legislation on pharmacovigilance. The marketing authorization holder should be responsible for continuously monitoring the safety of its medicinal products for human use, for informing the authorities of any changes that might have an impact on the marketing authorization, and for ensuring that the product information is kept up-to-date. Marketing authorization holders (MAH) record all suspected adverse reactions occurring in the European Union or in the third countries, and which are brought to their attention spontaneously by the patients or their health care, or occurring in the context of post-authorization study. For all medicinal products is mandatory to maintain a pharmacovigilance system master file (PSMF). According to the Legislative Decree 219/2006 the MAH must submit to the competent authorities the information on suspected adverse reactions of a medicinal product, in form of a periodic safety update reports (PSURs). PMID:24347978

  12. Pharmacovigilance in pharmaceutical companies: An overview.

    PubMed

    Mammì, Maria; Citraro, Rita; Torcasio, Giovanni; Cusato, Gennaro; Palleria, Caterina; di Paola, Eugenio Donato

    2013-12-01

    Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use and during clinical trials. In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products for human use. Regulation (EU) No 1235/2010 and Directive 2010/84/EU introduced new legislation on pharmacovigilance. The marketing authorization holder should be responsible for continuously monitoring the safety of its medicinal products for human use, for informing the authorities of any changes that might have an impact on the marketing authorization, and for ensuring that the product information is kept up-to-date. Marketing authorization holders (MAH) record all suspected adverse reactions occurring in the European Union or in the third countries, and which are brought to their attention spontaneously by the patients or their health care, or occurring in the context of post-authorization study. For all medicinal products is mandatory to maintain a pharmacovigilance system master file (PSMF). According to the Legislative Decree 219/2006 the MAH must submit to the competent authorities the information on suspected adverse reactions of a medicinal product, in form of a periodic safety update reports (PSURs).

  13. Child Pedestrians' Judgments of Safe Crossing Gaps at Three Different Vehicle Approach Speeds: A Preliminary Study.

    ERIC Educational Resources Information Center

    Connelly, Marie L.; And Others

    1996-01-01

    Judgments made by four children between seven and nine years of age regarding the safety of crossing a road in front of an approaching vehicle were studied. All participants consistently allowed smaller safety gaps as vehicle speeds increased, and three children often made potentially dangerous decisions at high vehicle speeds. (Author/PB)

  14. Safety of ceftriaxone in paediatrics: a systematic review protocol.

    PubMed

    Zeng, Linan; Choonara, Imti; Zhang, Lingli; Xue, Song; Chen, Zhe; He, Miaomiao

    2017-08-21

    Ceftriaxone is widely used in children in the treatment of sepsis. However, concerns have been raised about the safety of ceftriaxone, especially in young children. The aim of this review is to systematically evaluate the safety of ceftriaxone in children of all age groups. MEDLINE, PubMed, Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, International Pharmaceutical Abstracts and adverse drug reaction (ADR) monitoring systems will be systematically searched for randomised controlled trials (RCTs), cohort studies, case-control studies, cross-sectional studies, case series and case reports evaluating the safety of ceftriaxone in children. The Cochrane risk of bias tool, Newcastle-Ottawa and quality assessment tools developed by the National Institutes of Health will be used for quality assessment. Meta-analysis of the incidence of ADRs from RCTs and prospective studies will be done. Subgroup analyses will be performed for age and dosage regimen. Formal ethical approval is not required as no primary data are collected. This systematic review will be disseminated through a peer-reviewed publication and at conference meetings. CRD42017055428. © 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.

  15. 77 FR 32136 - Agency Information Collection Activities:

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-31

    ... Fire Safety Authority of Storage of Explosive Materials. (3) Agency form number, if any, and the... safety of emergency response personnel responding to fires at sites where explosives are stored. The information is provided both orally and in writing to the authority having jurisdiction for fire safety in the...

  16. Reducing the barriers against analytical epidemiological studies in investigations of local foodborne disease outbreaks in Germany - a starter kit for local health authorities.

    PubMed

    Werber, D; Bernard, H

    2014-02-27

    Thousands of infectious food-borne disease outbreaks (FBDO) are reported annually to the European Food Safety Authority within the framework of the zoonoses Directive (2003/99/EC). Most recognised FBDO occur locally following point source exposure, but only few are investigated using analytical epidemiological studies. In Germany, and probably also in other countries of the European Union, this seems to be particularly true for those investigated by local health authorities. Analytical studies, usually cohort studies or case–control studies, are a powerful tool to identify suspect food vehicles. Therefore, from a public health and food safety perspective, their more frequent usage is highly desirable. We have developed a small toolbox consisting of a strategic concept and a simple software tool for data entry and analysis, with the objective to increase the use of analytical studies in the investigation of local point source FBDO in Germany.

  17. Forms of Safety and Their Impact on Health: An Exploration of HIV/AIDS-Related Risk and Resilience Among Trans Women in Lebanon

    PubMed Central

    KAPLAN, RACHEL L.; WAGNER, GLENN J.; NEHME, SIMON; AUNON, FRANCES; KHOURI, DANIELLE; MOKHBAT, JACQUES

    2016-01-01

    Using minority stress theory, the authors investigated risk behaviors of transgender women (trans women) in Lebanon. Using semistructured interviews, the authors explored six areas: relationships with family and friends; openness about gender and sexuality; experiences with stigma; sexual behavior; attitudes and behaviors regarding HIV testing; and perceived HIV-related norms among transgender peers. Participants voiced the importance of different forms of safety: social/emotional, physical, sexual, and financial. Strategies for obtaining safety were negotiated differently depending on social, behavioral, and structural factors in the environment. In this article, we provide study findings from the perspectives of trans women, their exposure to stigma, and the necessary navigation of environments characterized by transphobia. PMID:24588138

  18. Forms of Safety and Their Impact on Health: An Exploration of HIV/AIDS-Related Risk and Resilience Among Trans Women in Lebanon.

    PubMed

    Kaplan, Rachel L; Wagner, Glenn J; Nehme, Simon; Aunon, Frances; Khouri, Danielle; Mokhbat, Jacques

    2015-01-01

    Using minority stress theory, the authors investigated risk behaviors of transgender women (trans women) in Lebanon. Using semistructured interviews, the authors explored six areas: relationships with family and friends; openness about gender and sexuality; experiences with stigma; sexual behavior; attitudes and behaviors regarding HIV testing; and perceived HIV-related norms among transgender peers. Participants voiced the importance of different forms of safety: social/emotional, physical, sexual, and financial. Strategies for obtaining safety were negotiated differently depending on social, behavioral, and structural factors in the environment. In this article, we provide study findings from the perspectives of trans women, their exposure to stigma, and the necessary navigation of environments characterized by transphobia.

  19. Safety review of Washington Metropolitan Area Transit Authority (WMATA) metrorail operations

    DOT National Transportation Integrated Search

    1997-09-01

    A recent series of accidents and incidents at the Washington Metropolitan Area Transit Authority (WMATA) have raised concerns about the Authority's commitment to safety as its top priority. In January 1996, a train operator was killed at an end-of-th...

  20. Index to Nuclear Safety: a technical progress review by chronology, permuted title, and author, Volume 18 (1) through Volume 22 (6)

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Cottrell, W.B.; Passiakos, M.

    This index to Nuclear Safety covers articles published in Nuclear Safety, Volume 18, Number 1 (January-February 1977) through Volume 22, Number 6 (November-December 1981). The index is divided into three section: a chronological list of articles (including abstracts), a permuted-title (KWIC) index, and an author index. Nuclear Safety, a bimonthly technical progress review prepared by the Nuclear Safety Information Center, covers all safety aspects of nuclear power reactors and associated facilities. Over 300 technical articles published in Nuclear Safety in the last 5 years are listed in this index.

  1. Promoting a Culture of Safety as a Patient Safety Strategy

    PubMed Central

    Weaver, Sallie J.; Lubomksi, Lisa H.; Wilson, Renee F.; Pfoh, Elizabeth R.; Martinez, Kathryn A.; Dy, Sydney M.

    2015-01-01

    Developing a culture of safety is a core element of many efforts to improve patient safety and care quality. This systematic review identifies and assesses interventions used to promote safety culture or climate in acute care settings. The authors searched MEDLINE, CINAHL, PsycINFO, Cochrane, and EMBASE to identify relevant English-language studies published from January 2000 to October 2012. They selected studies that targeted health care workers practicing in inpatient settings and included data about change in patient safety culture or climate after a targeted intervention. Two raters independently screened 3679 abstracts (which yielded 33 eligible studies in 35 articles), extracted study data, and rated study quality and strength of evidence. Eight studies included executive walk rounds or interdisciplinary rounds; 8 evaluated multicomponent, unit-based interventions; and 20 included team training or communication initiatives. Twenty-nine studies reported some improvement in safety culture or patient outcomes, but measured outcomes were highly heterogeneous. Strength of evidence was low, and most studies were pre–post evaluations of low to moderate quality. Within these limits, evidence suggests that interventions can improve perceptions of safety culture and potentially reduce patient harm. PMID:23460092

  2. Transgenic maize event TC1507: Global status of food, feed, and environmental safety

    PubMed Central

    Baktavachalam, Gajendra B; Delaney, Bryan; Fisher, Tracey L; Ladics, Gregory S; Layton, Raymond J; Locke, Mary EH; Schmidt, Jean; Anderson, Jennifer A; Weber, Natalie N; Herman, Rod A; Evans, Steven L

    2015-01-01

    Maize (Zea mays) is a widely cultivated cereal that has been safely consumed by humans and animals for centuries. Transgenic or genetically engineered insect-resistant and herbicide-tolerant maize, are commercially grown on a broad scale. Event TC1507 (OECD unique identifier: DAS-Ø15Ø7–1) or the Herculex®# I trait, an insect-resistant and herbicide-tolerant maize expressing Cry1F and PAT proteins, has been registered for commercial cultivation in the US since 2001. A science-based safety assessment was conducted on TC1507 prior to commercialization. The safety assessment addressed allergenicity; acute oral toxicity; subchronic toxicity; substantial equivalence with conventional comparators, as well as environmental impact. Results from biochemical, physicochemical, and in silico investigations supported the conclusion that Cry1F and PAT proteins are unlikely to be either allergenic or toxic to humans. Also, findings from toxicological and animal feeding studies supported that maize with TC1507 is as safe and nutritious as conventional maize. Maize with TC1507 is not expected to behave differently than conventional maize in terms of its potential for invasiveness, gene flow to wild and weedy relatives, or impact on non-target organisms. These safety conclusions regarding TC1507 were acknowledged by over 20 regulatory agencies including United States Environment Protection Agency (US EPA), US Department of Agriculture (USDA), Canadian Food Inspection Agency (CFIA), and European Food Safety Authority (EFSA) before authorizing cultivation and/or food and feed uses. A comprehensive review of the safety studies on TC1507, as well as some benefits, are presented here to serve as a reference for regulatory agencies and decision makers in other countries where authorization of TC1507 is or will be pursued. PMID:26018138

  3. Transgenic maize event TC1507: Global status of food, feed, and environmental safety.

    PubMed

    Baktavachalam, Gajendra B; Delaney, Bryan; Fisher, Tracey L; Ladics, Gregory S; Layton, Raymond J; Locke, Mary Eh; Schmidt, Jean; Anderson, Jennifer A; Weber, Natalie N; Herman, Rod A; Evans, Steven L

    2015-01-01

    Maize (Zea mays) is a widely cultivated cereal that has been safely consumed by humans and animals for centuries. Transgenic or genetically engineered insect-resistant and herbicide-tolerant maize, are commercially grown on a broad scale. Event TC1507 (OECD unique identifier: DAS-Ø15Ø7-1) or the Herculex®(#) I trait, an insect-resistant and herbicide-tolerant maize expressing Cry1F and PAT proteins, has been registered for commercial cultivation in the US since 2001. A science-based safety assessment was conducted on TC1507 prior to commercialization. The safety assessment addressed allergenicity; acute oral toxicity; subchronic toxicity; substantial equivalence with conventional comparators, as well as environmental impact. Results from biochemical, physicochemical, and in silico investigations supported the conclusion that Cry1F and PAT proteins are unlikely to be either allergenic or toxic to humans. Also, findings from toxicological and animal feeding studies supported that maize with TC1507 is as safe and nutritious as conventional maize. Maize with TC1507 is not expected to behave differently than conventional maize in terms of its potential for invasiveness, gene flow to wild and weedy relatives, or impact on non-target organisms. These safety conclusions regarding TC1507 were acknowledged by over 20 regulatory agencies including United States Environment Protection Agency (US EPA), US Department of Agriculture (USDA), Canadian Food Inspection Agency (CFIA), and European Food Safety Authority (EFSA) before authorizing cultivation and/or food and feed uses. A comprehensive review of the safety studies on TC1507, as well as some benefits, are presented here to serve as a reference for regulatory agencies and decision makers in other countries where authorization of TC1507 is or will be pursued.

  4. 49 CFR 451.3 - Action by Approval Authority.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

  5. 49 CFR 451.3 - Action by Approval Authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

  6. 49 CFR 451.3 - Action by Approval Authority.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

  7. 49 CFR 451.3 - Action by Approval Authority.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

  8. 49 CFR 451.3 - Action by Approval Authority.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

  9. Revisiting the safety of aspartame.

    PubMed

    Choudhary, Arbind Kumar; Pretorius, Etheresia

    2017-09-01

    Aspartame is a synthetic dipeptide artificial sweetener, frequently used in foods, medications, and beverages, notably carbonated and powdered soft drinks. Since 1981, when aspartame was first approved by the US Food and Drug Administration, researchers have debated both its recommended safe dosage (40 mg/kg/d) and its general safety to organ systems. This review examines papers published between 2000 and 2016 on both the safe dosage and higher-than-recommended dosages and presents a concise synthesis of current trends. Data on the safe aspartame dosage are controversial, and the literature suggests there are potential side effects associated with aspartame consumption. Since aspartame consumption is on the rise, the safety of this sweetener should be revisited. Most of the literature available on the safety of aspartame is included in this review. Safety studies are based primarily on animal models, as data from human studies are limited. The existing animal studies and the limited human studies suggest that aspartame and its metabolites, whether consumed in quantities significantly higher than the recommended safe dosage or within recommended safe levels, may disrupt the oxidant/antioxidant balance, induce oxidative stress, and damage cell membrane integrity, potentially affecting a variety of cells and tissues and causing a deregulation of cellular function, ultimately leading to systemic inflammation. © The Author(s) 2017. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  10. 48 CFR 50.205-3 - Authorization of offers contingent upon SAFETY Act designation or certification before contract...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...; (2) To the contracting officer's knowledge, the Government has not provided advance notice so that... competition without SAFETY Act protections or the subject technology would be sold to the Government only with SAFETY Act protections. (b) Contracting officers shall not authorize offers contingent upon obtaining a...

  11. Effects of a senior practicum course on nursing students' confidence in speaking up for patient safety.

    PubMed

    Kent, Lauren; Anderson, Gabrielle; Ciocca, Rebecca; Shanks, Linda; Enlow, Michele

    2015-03-01

    As patient advocates, nurses are responsible for speaking up against unsafe practices. Nursing students must develop the confidence to speak up for patient safety so that they can hold themselves, as well as their peers and coworkers, accountable for patients' well-being. The purpose of this study was to examine the effects of a senior practicum course on confidence for speaking up for patient safety in nursing students. Confidence in speaking up for patient safety was measured with the Health Professional Education in Patient Safety Survey. The study showed a significant increase in nursing students' confidence after the senior practicum course, but there was no significant change in students' confidence in questioning someone of authority. Copyright 2015, SLACK Incorporated.

  12. Ventilator-Related Adverse Events: A Taxonomy and Findings From 3 Incident Reporting Systems.

    PubMed

    Pham, Julius Cuong; Williams, Tamara L; Sparnon, Erin M; Cillie, Tam K; Scharen, Hilda F; Marella, William M

    2016-05-01

    In 2009, researchers from Johns Hopkins University's Armstrong Institute for Patient Safety and Quality; public agencies, including the FDA; and private partners, including the Emergency Care Research Institute and the University HealthSystem Consortium (UHC) Safety Intelligence Patient Safety Organization, sought to form a public-private partnership for the promotion of patient safety (P5S) to advance patient safety through voluntary partnerships. The study objective was to test the concept of the P5S to advance our understanding of safety issues related to ventilator events, to develop a common classification system for categorizing adverse events related to mechanical ventilators, and to perform a comparison of adverse events across different adverse event reporting systems. We performed a cross-sectional analysis of ventilator-related adverse events reported in 2012 from the following incident reporting systems: the Pennsylvania Patient Safety Authority's Patient Safety Reporting System, UHC's Safety Intelligence Patient Safety Organization database, and the FDA's Manufacturer and User Facility Device Experience database. Once each organization had its dataset of ventilator-related adverse events, reviewers read the narrative descriptions of each event and classified it according to the developed common taxonomy. A Pennsylvania Patient Safety Authority, FDA, and UHC search provided 252, 274, and 700 relevant reports, respectively. The 3 event types most commonly reported to the UHC and the Pennsylvania Patient Safety Authority's Patient Safety Reporting System databases were airway/breathing circuit issue, human factor issues, and ventilator malfunction events. The top 3 event types reported to the FDA were ventilator malfunction, power source issue, and alarm failure. Overall, we found that (1) through the development of a common taxonomy, adverse events from 3 reporting systems can be evaluated, (2) the types of events reported in each database were related to the purpose of the database and the source of the reports, resulting in significant differences in reported event categories across the 3 systems, and (3) a public-private collaboration for investigating ventilator-related adverse events under the P5S model is feasible. Copyright © 2016 by Daedalus Enterprises.

  13. 31 CFR 586.515 - Payments for services rendered by the Government of the FRY (S&M) to aircraft authorized...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Government of the FRY (S&M) to aircraft authorized; aircraft and maritime safety. 586.515 Section 586.515... services rendered by the Government of the FRY (S&M) to aircraft authorized; aircraft and maritime safety... maritime traffic in international waters. ...

  14. 78 FR 76191 - Operational Tests and Inspections for Compliance With Maximum Authorized Train Speeds and Other...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-16

    ... Tests and Inspections for Compliance With Maximum Authorized Train Speeds and Other Speed Restrictions... safety advisory; Operational tests and inspections for compliance with maximum authorized train speeds and other speed restrictions. SUMMARY: FRA is issuing Safety Advisory 2013-08 to stress to railroads...

  15. Statistical classification of drug incidents due to look-alike sound-alike mix-ups.

    PubMed

    Wong, Zoie Shui Yee

    2016-06-01

    It has been recognised that medication names that look or sound similar are a cause of medication errors. This study builds statistical classifiers for identifying medication incidents due to look-alike sound-alike mix-ups. A total of 227 patient safety incident advisories related to medication were obtained from the Canadian Patient Safety Institute's Global Patient Safety Alerts system. Eight feature selection strategies based on frequent terms, frequent drug terms and constituent terms were performed. Statistical text classifiers based on logistic regression, support vector machines with linear, polynomial, radial-basis and sigmoid kernels and decision tree were trained and tested. The models developed achieved an average accuracy of above 0.8 across all the model settings. The receiver operating characteristic curves indicated the classifiers performed reasonably well. The results obtained in this study suggest that statistical text classification can be a feasible method for identifying medication incidents due to look-alike sound-alike mix-ups based on a database of advisories from Global Patient Safety Alerts. © The Author(s) 2014.

  16. Researching Reflexively With Patients and Families: Two Studies Using Video-Reflexive Ethnography to Collaborate With Patients and Families in Patient Safety Research.

    PubMed

    Collier, Aileen; Wyer, Mary

    2016-06-01

    Patient safety research has to date offered few opportunities for patients and families to be actively involved in the research process. This article describes our collaboration with patients and families in two separate studies, involving end-of-life care and infection control in acute care. We used the collaborative methodology of video-reflexive ethnography, which has been primarily used with clinicians, to involve patients and families as active participants and collaborators in our research. The purpose of this article is to share our experiences and findings that iterative researcher reflexivity in the field was critical to the progress and success of each study. We present and analyze the complexities of reflexivity-in-the-field through a framework of multilayered reflexivity. We share our lessons here for other researchers seeking to actively involve patients and families in patient safety research using collaborative visual methods. © The Author(s) 2015.

  17. Safety climate in OHSAS 18001-certified organisations: antecedents and consequences of safety behaviour.

    PubMed

    Fernández-Muñiz, Beatriz; Montes-Peón, José Manuel; Vázquez-Ordás, Camilo José

    2012-03-01

    The occupational health and safety standard OHSAS 18001 has gained considerable acceptance worldwide, and firms from diverse sectors and of varying sizes have implemented it. Despite this, very few studies have analysed safety management or the safety climate in OHSAS 18001-certified organisations. The current work aims to analyse the safety climate in these organisations, identify its dimensions, and propose and test a structural equation model that will help determine the antecedents and consequences of employees' safety behaviour. For this purpose, the authors carry out an empirical study using a sample of 131 OHSAS 18001-certified organisations located in Spain. The results show that management's commitment, and particularly communication, have an effect on safety behaviour and on safety performance, employee satisfaction, and firm competitiveness. These findings are particularly important for management since they provide evidence about the factors that should be encouraged to reduce risks and improve performance in this type of organisation. Copyright © 2011 Elsevier Ltd. All rights reserved.

  18. IRQN award paper: Operational rounds: a practical administrative process to improve safety and clinical services in radiology.

    PubMed

    Donnelly, Lane F; Dickerson, Julie M; Lehkamp, Todd W; Gessner, Kevin E; Moskovitz, Jay; Hutchinson, Sally

    2008-11-01

    As part of a patient safety program in the authors' department of radiology, operational rounds have been instituted. This process consists of radiology leaders' visiting imaging divisions at the site of imaging and discussing frontline employees' concerns about patient safety, the quality of care, and patient and family satisfaction. Operational rounds are executed at a time to optimize the number of attendees. Minutes that describe the issues identified, persons responsible for improvement, and updated improvement plan status are available to employees online. Via this process, multiple patient safety and other issues have been identified and remedied. The authors believe that the process has improved patient safety, the quality of care, and the efficiency of operations. Since the inception of the safety program, the mean number of days between serious safety events involving radiology has doubled. The authors review the background around such walk rounds, describe their particular program, and give multiple illustrative examples of issues identified and improvement plans put in place.

  19. Developing implementation strategies for firearm safety promotion in paediatric primary care for suicide prevention in two large US health systems: a study protocol for a mixed-methods implementation study.

    PubMed

    Wolk, Courtney Benjamin; Jager-Hyman, Shari; Marcus, Steven C; Ahmedani, Brian K; Zeber, John E; Fein, Joel A; Brown, Gregory K; Lieberman, Adina; Beidas, Rinad S

    2017-06-24

    The promotion of safe firearm practices, or firearms means restriction, is a promising but infrequently used suicide prevention strategy in the USA. Safety Check is an evidence-based practice for improving parental firearm safety behaviour in paediatric primary care. However, providers rarely discuss firearm safety during visits, suggesting the need to better understand barriers and facilitators to promoting this approach. This study, Adolescent Suicide Prevention In Routine clinical Encounters, aims to engender a better understanding of how to implement the three firearm components of Safety Check as a suicide prevention strategy in paediatric primary care. The National Institute of Mental Health-funded Mental Health Research Network (MHRN), a consortium of 13 healthcare systems across the USA, affords a unique opportunity to better understand how to implement a firearm safety intervention in paediatric primary care from a system-level perspective. We will collaboratively develop implementation strategies in partnership with MHRN stakeholders. First, we will survey leadership of 82 primary care practices (ie, practices serving children, adolescents and young adults) within two MHRN systems to understand acceptability and use of the three firearm components of Safety Check (ie, screening, brief counselling around firearm safety and provision of firearm locks). Then, in collaboration with MHRN stakeholders, we will use intervention mapping and the Consolidated Framework for Implementation Research to systematically develop and evaluate a multilevel menu of implementation strategies for promoting firearm safety as a suicide prevention strategy in paediatric primary care. Study procedures have been approved by the University of Pennsylvania. Henry Ford Health System and Baylor Scott & White institutional review boards (IRBs) have ceded IRB review to the University of Pennsylvania IRB. Results will be submitted for publication in peer-reviewed journals. © 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.

  20. Most common road safety engineering deficiencies in South Eastern Europe as a part of safe system approach

    NASA Astrophysics Data System (ADS)

    Jovanov, D.; Vollpracht, H. J.; Beles, H.; Popa, V.; Tolea, B. A.

    2017-10-01

    Most common road safety engineering deficiencies identified by the authors in South Eastern Europe, including Romania, have been collected together and presented in this paper as a part of road safety unbreakably connected to the safe system approach (driver-vehicle-road). In different South Eastern Europe countries Road Safety Audit (RSA), Road Safety Inspection (RSI), as well as Black Spot Management (BSM) was introduced and practical implementation experience enabled the authors to analyze the road safety problems. Typical road safety engineering deficiencies have been presented in 8 different subsections, based on PIARC (World Road Association) RSA approach. This paper presents collected common road safety problems with relevant illustrations (real pictures) with associated accident risks.

  1. Safety leadership in the teaching laboratories of electrical and electronic engineering departments at Taiwanese Universities.

    PubMed

    Wu, Tsung-Chih

    2008-01-01

    Safety has always been one of the principal goals in teaching laboratories. Laboratories cannot serve their educational purpose when accidents occur. The leadership of department heads has a major impact on laboratory safety, so this study discusses the factors affecting safety leadership in teaching laboratories. This study uses a mail survey to explore the perceived safety leadership in electrical and electronic engineering departments at Taiwanese universities. An exploratory factor analysis shows that there are three main components of safety leadership, as measured on a safety leadership scale: safety controlling, safety coaching, and safety caring. The descriptive statistics also reveals that among faculty, the perception of department heads' safety leadership is in general positive. A two-way MANOVA shows that there are interaction effects on safety leadership between university size and instructor age; there are also interaction effects between presence of a safety committee and faculty gender and faculty age. It is therefore necessary to assess organizational factors when determining whether individual factors are the cause of differing perceptions among faculty members. The author also presents advice on improving safety leadership for department heads at small universities and at universities without safety committees.

  2. 14 CFR 1204.509 - Delegation of authority to take action regarding “liquidated damage” assessments under the...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... regarding âliquidated damageâ assessments under the Contract Work Hours and Safety Standards Act, and... authority to take action regarding “liquidated damage” assessments under the Contract Work Hours and Safety... nonconstruction contracts as they are subject to the Conract Work Hours and Safety Standards Act, in regards to...

  3. 14 CFR 1204.509 - Delegation of authority to take action regarding “liquidated damage” assessments under the...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... regarding âliquidated damageâ assessments under the Contract Work Hours and Safety Standards Act, and... authority to take action regarding “liquidated damage” assessments under the Contract Work Hours and Safety... nonconstruction contracts as they are subject to the Conract Work Hours and Safety Standards Act, in regards to...

  4. Food safety knowledge and hygiene practices among veterinary medicine students at Trakia University, Bulgaria.

    PubMed

    Stratev, Deyan; Odeyemi, Olumide A; Pavlov, Alexander; Kyuchukova, Ralica; Fatehi, Foad; Bamidele, Florence A

    The results from the first survey on food safety knowledge, attitudes and hygiene practices (KAP) among veterinary medicine students in Bulgaria are reported in this study. It was designed and conducted from September to December 2015 using structured questionnaires on food safety knowledge, attitudes and practices. Data were collected from 100 undergraduate veterinary medicine students from the Trakia University, Bulgaria. It was observed that the age and the gender did not affect food safety knowledge, attitudes and practices. There was no significant difference (p>0.05) on food safety knowledge and practices among students based on the years of study. A high level of food safety knowledge was observed among the participants (85.06%), however, the practice of food safety was above average (65.28%) while attitude toward food safety was high (70%). Although there was a significant awareness of food safety knowledge among respondents, there is a need for improvement on food safety practices, interventions on food safety and foodborne diseases. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  5. Pacific Northwest Laboratory annual report for 1980 to the DOE Assistant Secretary for Environment. Part 5. Environmental assessment, control, health and safety

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Baalman, R.W.; Hays, I.D.

    1981-02-01

    Pacific Northwest Laboratory's (PNL) 1980 annual report to the DOE Assistant Secretary for Environment describes research in environment, health, and safety conducted during fiscal year 1980. Part 5 includes technology assessments for natural gas, enhanced oil recovery, oil shale, uranium mining, magnetic fusion energy, solar energy, uranium enrichment and industrial energy utilization; regional analysis studies of environmental transport and community impacts; environmental and safety engineering for LNG, oil spills, LPG, shale oil waste waters, geothermal liquid waste disposal, compressed air energy storage, and nuclear/fusion fuel cycles; operational and environmental safety studies of decommissioning, environmental monitoring, personnel dosimetry, and analysis ofmore » criticality safety; health physics studies; and epidemiological studies. Also included are an author index, organization of PNL charts and distribution lists of the annual report, along with lists of presentations and publications. (DLS)« less

  6. Measuring patient safety culture in maternal and child health institutions in China: a qualitative study.

    PubMed

    Wang, Yuanyuan; Liu, Weiwei; Shi, Huifeng; Liu, Chaojie; Wang, Yan

    2017-07-12

    Patient safety culture (PSC) plays a critical role in ensuring safe and quality care. Extensive PSC studies have been undertaken in hospitals. However, little is known about PSC in maternal and child health (MCH) institutions in China, which provide both population-based preventive services as well as individual care for patients. This study aimed to develop a theoretical framework for conceptualising PSC in MCH institutions in China. The study was undertaken in six MCH institutions (three in Hebei and three in Beijing). Participants (n=118) were recruited through stratified purposive sampling: 20 managers/administrators, 59 care providers and 39 patients. In-depth interviews were conducted with the participants. The interview data were coded using both inductive (based on the existing PSC theory developed by the Agency for Healthcare Research and Quality) and deductive (open coding arising from data) approaches. A PSC framework was formulated through axial coding that connected initial codes and selective coding that extracted a small number of themes. The interviewees considered patient safety in relation to six aspects: safety and security in public spaces, safety of medical services, privacy and information security, financial security, psychological safety and gap in services. A 12-dimensional PSC framework was developed, containing 69 items. While the existing PSC theory was confirmed by this study, some new themes emerged from the data. Patients expressed particular concerns about psychological safety and financial security. Defensive medical practices emerged as a PSC dimension that is associated with not only medical safety but also financial security and psychological safety. Patient engagement was also valued by the interviewees, especially the patients, as part of PSC. Although there are some common features in PSC across different healthcare delivery systems, PSC can also be context specific. In MCH settings in China, the meaning of 'patient safety' goes beyond the traditional definition of patients. General well-being, health and disease prevention are important anchor points for defining PSC in such settings. © 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.

  7. 14 CFR 1204.509 - Delegation of authority to take action regarding “liquidated damage” assessments under the...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... regarding âliquidated damageâ assessments under the Contract Work Hours and Safety Standards Act, and... authority to take action regarding “liquidated damage” assessments under the Contract Work Hours and Safety Standards Act, and associated labor statutes. (a) Delegation of authority. The Director, Industrial...

  8. 49 CFR 831.3 - Authority of Directors.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety, and Office of Pipeline and Hazardous Materials Safety, subject to the provisions of § 831.2 and part 800 of this...

  9. 49 CFR 831.3 - Authority of Directors.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety, and Office of Pipeline and Hazardous Materials Safety, subject to the provisions of § 831.2 and part 800 of this...

  10. 49 CFR 831.3 - Authority of Directors.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety, and Office of Pipeline and Hazardous Materials Safety, subject to the provisions of § 831.2 and part 800 of this...

  11. 49 CFR 831.3 - Authority of Directors.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety, and Office of Pipeline and Hazardous Materials Safety, subject to the provisions of § 831.2 and part 800 of this...

  12. Perceptions of Supervision Among Injured and Non-Injured Teens Working in the Retail or Service Industry.

    PubMed

    Zierold, Kristina M

    2016-04-01

    According to the National Institute for Occupational Safety and Health (NIOSH), a teen is injured every 9 minutes at work. Workplace supervision may affect whether teens are injured on the job. Because research on workplace supervision among teens is limited, the objectives of this study were to characterize the perceptions of supervision among injured and non-injured teen workers and assess the characteristics and perceptions of supervisors that may be associated with work-related injuries. In 2011, a cross-sectional survey was conducted among high school students. Teens who worked in retail or service industries (n= 270) were included in the sample. Non-injured teens were more likely to have reported that their supervisors cared about their safety, were helpful, listened well, and ensured that teen workers understood workplace safety. Most teens (70%) did not feel comfortable talking about safety issues with their supervisors. The importance of supervision and how supervisors are perceived in the workplace may be significant in creating a safety culture that leaves a lasting impression. © 2015 The Author(s).

  13. Predictors of Payer Mix and Financial Performance Among Safety Net Hospitals Prior to the Affordable Care Act.

    PubMed

    Sommers, Benjamin D; Stone, Juliana; Kane, Nancy

    2016-01-01

    The objective of this study was to use audited hospital financial statements to identify predictors of payer mix and financial performance in safety net hospitals prior to the Affordable Care Act. We analyzed the 2010 financial statements of 98 large, urban safety net hospital systems in 34 states, supplemented with data on population demographics, hospital features, and state policies. We used multivariate regression to identify independent predictors of three outcomes: 1) Medicaid-reliant payer mix (hospitals for which at least 25% of hospital days are paid for by Medicaid); 2) safety net revenue-to-cost ratio (Medicaid and Medicare Disproportionate Share Hospital payments and local government transfers, divided by charity care costs and Medicaid payment shortfall); and 3) operating margin. Medicaid-reliant payer mix was positively associated with more inclusive state Medicaid eligibility criteria and more minority patients. More inclusive Medicaid eligibility and higher Medicaid reimbursement rates positively predicted safety net revenue-to-cost ratio. University governance was the strongest positive predictor of operating margin. Safety net hospital financial performance varied considerably. Academic hospitals had higher operating margins, while more generous Medicaid eligibility and reimbursement policies improved hospitals' ability to recoup costs. Institutional and state policies may outweigh patient demographics in the financial health of safety net hospitals. © The Author(s) 2015.

  14. Integrated Framework for Patient Safety and Energy Efficiency in Healthcare Facilities Retrofit Projects.

    PubMed

    Mohammadpour, Atefeh; Anumba, Chimay J; Messner, John I

    2016-07-01

    There is a growing focus on enhancing energy efficiency in healthcare facilities, many of which are decades old. Since replacement of all aging healthcare facilities is not economically feasible, the retrofitting of these facilities is an appropriate path, which also provides an opportunity to incorporate energy efficiency measures. In undertaking energy efficiency retrofits, it is vital that the safety of the patients in these facilities is maintained or enhanced. However, the interactions between patient safety and energy efficiency have not been adequately addressed to realize the full benefits of retrofitting healthcare facilities. To address this, an innovative integrated framework, the Patient Safety and Energy Efficiency (PATSiE) framework, was developed to simultaneously enhance patient safety and energy efficiency. The framework includes a step -: by -: step procedure for enhancing both patient safety and energy efficiency. It provides a structured overview of the different stages involved in retrofitting healthcare facilities and improves understanding of the intricacies associated with integrating patient safety improvements with energy efficiency enhancements. Evaluation of the PATSiE framework was conducted through focus groups with the key stakeholders in two case study healthcare facilities. The feedback from these stakeholders was generally positive, as they considered the framework useful and applicable to retrofit projects in the healthcare industry. © The Author(s) 2016.

  15. Effects of health information technology on patient outcomes: a systematic review.

    PubMed

    Brenner, Samantha K; Kaushal, Rainu; Grinspan, Zachary; Joyce, Christine; Kim, Inho; Allard, Rhonda J; Delgado, Diana; Abramson, Erika L

    2016-09-01

    To systematically review studies assessing the effects of health information technology (health IT) on patient safety outcomes. The authors employed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement methods. MEDLINE, Cumulative Index to Nursing Allied Health (CINAHL), EMBASE, and Cochrane Library databases, from 2001 to June 2012, were searched. Descriptive and comparative studies were included that involved use of health IT in a clinical setting and measured effects on patient safety outcomes. Data on setting, subjects, information technology implemented, and type of patient safety outcomes were all abstracted. The quality of the studies was evaluated by 2 independent reviewers (scored from 0 to 10). A total of 69 studies met inclusion criteria. Quality scores ranged from 1 to 9. There were 25 (36%) studies that found benefit of health IT on direct patient safety outcomes for the primary outcome measured, 43 (62%) studies that either had non-significant or mixed findings, and 1 (1%) study for which health IT had a detrimental effect. Neither the quality of the studies nor the rate of randomized control trials performed changed over time. Most studies that demonstrated a positive benefit of health IT on direct patient safety outcomes were inpatient, single-center, and either cohort or observational trials studying clinical decision support or computerized provider order entry. Many areas of health IT application remain understudied and the majority of studies have non-significant or mixed findings. Our study suggests that larger, higher quality studies need to be conducted, particularly in the long-term care and ambulatory care settings. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  16. Managing risks of noncancer health effects at hazardous waste sites: A case study using the Reference Concentration (RfC) of trichloroethylene (TCE).

    PubMed

    Dourson, Michael L; Gadagbui, Bernard K; Thompson, Rod B; Pfau, Edward J; Lowe, John

    2016-10-01

    A method for determining a safety range for non-cancer risks is proposed, similar in concept to the range used for cancer in the management of waste sites. This safety range brings transparency to the chemical specific Reference Dose or Concentration by replacing their "order of magnitude" definitions with a scientifically-based range. EPA's multiple RfCs for trichloroethylene (TCE) were evaluated as a case study. For TCE, a multi-endpoint safety range was judged to be 3 μg/m(3) to 30 μg/m,(3) based on a review of kidney effects found in NTP (1988), thymus effects found in Keil et al. (2009) and cardiac effects found in the Johnson et al. (2003) study. This multi-endpoint safety range is derived from studies for which the appropriate averaging time corresponds to different exposure durations, and, therefore, can be applied to both long- and short-term exposures with appropriate consideration of exposure averaging times. For shorter-term exposures, averaging time should be based on the time of cardiac development in humans during fetal growth, an average of approximately 20-25 days. Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.

  17. Ethnic Minority Youth in Youth Programs: Feelings of Safety, Relationships with Adult Staff, and Perceptions of Learning Social Skills

    ERIC Educational Resources Information Center

    Lee, Sun-A; Borden, Lynne M.; Serido, Joyce; Perkins, Daniel F.

    2009-01-01

    The authors examine perceptions that young people hold regarding their participation in community-based youth programs. Specifically, this study assesses young people's sense of psychological safety, their relationships with adult staff, their learning of social skills, and how different ethnic groups experience these factors. Data for the study…

  18. 77 FR 11353 - Defense Federal Acquisition Regulation Supplement: Award Fee Reduction or Denial for Health or...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-24

    ... Denial for Health or Safety Issues (DFARS Case 2011-D033) AGENCY: Defense Acquisition Regulations System... authorities to reduce or deny award fees to companies found to jeopardize the health or safety of Government... authorities to reduce or deny award fees to companies found to jeopardize the health or safety of Government...

  19. 75 FR 57659 - Airworthiness Directives Eurocopter France (ECF) Model SA-365N1, AS-365N2, AS 365 N3, EC 155B...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-22

    ... aviation authority of the European Aviation Safety Agency (EASA). The MCAI AD reports the separation and...: DOT/FAA Southwest Region, Gary Roach, ASW-111, Aviation Safety Engineer, Rotorcraft Directorate... Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety...

  20. 7 CFR 2.51 - Deputy Under Secretary for Food Safety.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 1 2010-01-01 2010-01-01 false Deputy Under Secretary for Food Safety. 2.51 Section 2.51 Agriculture Office of the Secretary of Agriculture DELEGATIONS OF AUTHORITY BY THE SECRETARY OF AGRICULTURE AND GENERAL OFFICERS OF THE DEPARTMENT Delegations of Authority by the Under Secretary for Food Safety § 2.51 Deputy Under Secretary for...

  1. 7 CFR 2.51 - Deputy Under Secretary for Food Safety.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 1 2011-01-01 2011-01-01 false Deputy Under Secretary for Food Safety. 2.51 Section 2.51 Agriculture Office of the Secretary of Agriculture DELEGATIONS OF AUTHORITY BY THE SECRETARY OF AGRICULTURE AND GENERAL OFFICERS OF THE DEPARTMENT Delegations of Authority by the Under Secretary for Food Safety § 2.51 Deputy Under Secretary for...

  2. 7 CFR 2.51 - Deputy Under Secretary for Food Safety.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 1 2014-01-01 2014-01-01 false Deputy Under Secretary for Food Safety. 2.51 Section 2.51 Agriculture Office of the Secretary of Agriculture DELEGATIONS OF AUTHORITY BY THE SECRETARY OF AGRICULTURE AND GENERAL OFFICERS OF THE DEPARTMENT Delegations of Authority by the Under Secretary for Food Safety § 2.51 Deputy Under Secretary for...

  3. 7 CFR 2.51 - Deputy Under Secretary for Food Safety.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 1 2012-01-01 2012-01-01 false Deputy Under Secretary for Food Safety. 2.51 Section 2.51 Agriculture Office of the Secretary of Agriculture DELEGATIONS OF AUTHORITY BY THE SECRETARY OF AGRICULTURE AND GENERAL OFFICERS OF THE DEPARTMENT Delegations of Authority by the Under Secretary for Food Safety § 2.51 Deputy Under Secretary for...

  4. 7 CFR 2.51 - Deputy Under Secretary for Food Safety.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 1 2013-01-01 2013-01-01 false Deputy Under Secretary for Food Safety. 2.51 Section 2.51 Agriculture Office of the Secretary of Agriculture DELEGATIONS OF AUTHORITY BY THE SECRETARY OF AGRICULTURE AND GENERAL OFFICERS OF THE DEPARTMENT Delegations of Authority by the Under Secretary for Food Safety § 2.51 Deputy Under Secretary for...

  5. Steps towards the international regulatory acceptance of non-animal methodology in safety assessment.

    PubMed

    Sewell, Fiona; Doe, John; Gellatly, Nichola; Ragan, Ian; Burden, Natalie

    2017-10-01

    The current animal-based paradigm for safety assessment must change. In September 2016, the UK National Centre for Replacement, Refinement and Reduction of Animals in Research (NC3Rs) brought together scientists from regulatory authorities, academia and industry to review progress in bringing new methodology into regulatory use, and to identify ways to expedite progress. Progress has been slow. Science is advancing to make this possible but changes are necessary. The new paradigm should allow new methodology to be adopted once it is developed rather than being based on a fixed set of studies. Regulatory authorities can help by developing Performance-Based Standards. The most pressing need is in repeat dose toxicology, although setting standards will be more complex than in areas such as sensitization. Performance standards should be aimed directly at human safety, not at reproducing the results of animal studies. Regulatory authorities can also aid progress towards the acceptance of non-animal based methodology by promoting "safe-haven" trials where traditional and new methodology data can be submitted in parallel to build up experience in the new methods. Industry can play its part in the acceptance of new methodology, by contributing to the setting of performance standards and by actively contributing to "safe-haven" trials. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  6. Safety Assessment of Synthetic Fluorphlogopite as Used in Cosmetics.

    PubMed

    Becker, Lillian C; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

    2015-01-01

    The Cosmetic Ingredient Review Expert Panel (the Panel) reviewed the safety of synthetic fluorphlogopite as used in cosmetics. Synthetic fluorphlogopite functions as a bulking agent and a viscosity-increasing agent. The Panel reviewed available animal and human data related to this ingredient along with a previous safety assessment of other magnesium silicates. The Panel concluded that synthetic fluorphlogopite was safe as cosmetic ingredients in the practices of use and concentration as given in this safety assessment. © The Author(s) 2015.

  7. Highway Safety Program Manual: Volume 14: Pedestrian Safety.

    ERIC Educational Resources Information Center

    National Highway Traffic Safety Administration (DOT), Washington, DC.

    Volume 14 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on pedestrian safety. The purpose and objectives of a pedestrian safety program are outlined. Federal authority in the area of pedestrian safety and policies regarding a safety program…

  8. 77 FR 76232 - Airworthiness Directives; GA200 (Pty) Ltd Airplanes

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-27

    ..., Amendment 39-17187 (77 FR 55686, September 11, 2012), the Civil Aviation Safety Authority (CASA), which is...-200. (h) Related Information Refer to MCAI Civil Aviation Safety Authority (CASA) AD AD/ GA200/1...

  9. Efficacy and safety of darunavir (Prezista®) with low-dose ritonavir and other antiretroviral medications in subtype F HIV-1 infected, treatment-experienced subjects in Romania: a post-authorization, open-label, one-cohort, non-interventional, prospective study

    PubMed Central

    Benea, Otilia Elisabeta; Streinu-Cercel, Adrian; Dorobăţ, Carmen; Rugină, Sorin; Negruţiu, Lucian; Cupşa, Augustin; Duiculescu, Dan; Chiriac, Carmen; Itu, Corina; Prisăcariu, Liviu Jany; Iosif, Ionel

    2014-01-01

    Introduction The aim of the study was to assess the safety and efficacy of darunavir (Prezista®) used in subtype F human immunodeficiency virus – type 1 (HIV-1) infected, antiretroviral therapy (ART)-experienced patients in Romania in routine clinical practice. Methods This was a post-authorization, open-label, one-cohort, non-interventional, prospective study conducted at multiple sites in Romania to assess efficacy (CD4 cell count, viral load, and treatment compliance) and safety ([serious] adverse events, clinical laboratory evaluation, and vital signs) of darunavir in combination with low-dose ritonavir (DRV/r) and other antiretroviral (ARV) medications in subtype F HIV-1 infected subjects in naturalistic settings. Seventy-eight subjects were recruited by 9 investigational sites and received 600/100 mg DRV/r twice daily. Results Treatment with DRV/r administered with other ARV medications resulted in the expected, statistically relevant improvement of CD4 cell count and viral load in subjects eligible for such treatment. In addition, adherence to treatment was high and the treatment-emergent safety profile observed during this study was consistent with the established safety profile of darunavir. Conclusion DRV/r administered in combination with other ARV medications in subtype F HIV-1 infected subjects in naturalistic settings proved to be an effective and safe treatment in Romania. Trial registration NCT01253967 PMID:25276665

  10. 14 CFR § 1204.509 - Delegation of authority to take action regarding “liquidated damage” assessments under the...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... regarding âliquidated damageâ assessments under the Contract Work Hours and Safety Standards Act, and... Hours and Safety Standards Act, and associated labor statutes. (a) Delegation of authority. The Director, Industrial Relations Office, is hereby delegated the authority to act for the Administrator in all matters...

  11. Barriers to Implementing a Reporting and Learning Patient Safety System: Pediatric Chiropractic Perspective.

    PubMed

    Pohlman, Katherine A; Carroll, Linda; Hartling, Lisa; Tsuyuki, Ross T; Vohra, Sunita

    2016-04-01

    A reporting and learning system is a method of monitoring the occurrence of incidents that affect patient safety. This cross-sectional survey asked pediatric chiropractors about factors that may limit their participation in such a system. The list of potential barriers for participation was developed using a systematic approach. All members of the 2 pediatric councils associated with US national chiropractic organizations were invited to complete the survey (N = 400). The cross-sectional survey was created using an online survey tool (REDCap) and sent directly to member emails addressed by the respective executive committees. Of the 400 potential respondents, 81 responded (20.3%). The most common limitations to participating were identified as time pressure (96%) and patient concerns (81%). Reporting and learning systems have been utilized to increase safety awareness in many high-risk industries. To be successful, future patient safety studies with pediatric chiropractors need to ensure these barriers are understood and addressed. © The Author(s) 2015.

  12. 49 CFR 831.3 - Authority of Directors.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety, and Office of Pipeline and Hazardous Materials Safety, subject to the provisions of § 831.2 and part 800 of this... Transportation Other Regulations Relating to Transportation (Continued) NATIONAL TRANSPORTATION SAFETY BOARD...

  13. Enhancing patient safety: improving the patient handoff process through appreciative inquiry.

    PubMed

    Shendell-Falik, Nancy; Feinson, Michael; Mohr, Bernard J

    2007-02-01

    Patient transfers from one care giver to another are an area of high safety consequence, as is evident by many studies and the Joint Commission on Accreditation of Healthcare Organization's Patient Safety Goals. The authors describe how one hospital made measurable improvements in a patient handoff process by using an unconventional approach to change called appreciative inquiry. Rather than identifying the root causes of ineffective handoffs, appreciative inquiry was used to engage staff in identifying and building on their most effective handoff experiences.

  14. Identifying positively deviant elderly medical wards using routinely collected NHS Safety Thermometer data: an observational study.

    PubMed

    Baxter, Ruth; Taylor, Natalie; Kellar, Ian; Pye, Victoria; Mohammed, Mohammed A; Lawton, Rebecca

    2018-02-16

    The positive deviance approach seeks to identify and learn from exceptional performers. Although a framework exists to apply positive deviance within healthcare organisations, there is limited guidance to support its implementation. The approach has also rarely explored exceptional performance on broad outcomes, been implemented at ward level, or applied within the UK. This study develops and critically appraises a pragmatic method for identifying positively deviant wards using a routinely collected, broad measure of patient safety. A two-phased observational study was conducted. During phase 1, cross-sectional and temporal analyses of Safety Thermometer data were conducted to identify a discrete group of positively deviant wards that consistently demonstrated exceptional levels of safety. A group of matched comparison wards with above average performances were also identified. During phase 2, multidisciplinary staff and patients on the positively deviant and comparison wards completed surveys to explore whether their perceptions of safety supported the identification of positively deviant wards. 34 elderly medical wards within a northern region of England, UK. Multidisciplinary staff (n=161) and patients (n=188) clustered within nine positively deviant and comparison wards. Phase 1: A combination of analyses identified five positively deviant wards that performed best in the region, outperformed their organisation and performed consistently well over 12 months. Five above average matched comparator wards were also identified. Phase 2: Staff and patient perceptions of safety generally supported the identification of positively deviant wards using Safety Thermometer data, although patient perceptions of safety were less concordant with the routinely collected data. This study tentatively supports a pragmatic method of using routinely collected data to identify positively deviant elderly medical wards; however, it also highlights the various challenges that are faced when conducting the first stage of the positive deviance approach. UK Clinical Research Network Portfolio (reference-18050). © 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 expressly granted.

  15. Protocol for a multicentre, multistage, prospective study in China using system-based approaches for consistent improvement in surgical safety.

    PubMed

    Yu, Xiaochu; Jiang, Jingmei; Liu, Changwei; Shen, Keng; Wang, Zixing; Han, Wei; Liu, Xingrong; Lin, Guole; Zhang, Ye; Zhang, Ying; Ma, Yufen; Bo, Haixin; Zhao, Yupei

    2017-06-15

    Surgical safety has emerged as a crucial global health issue in the past two decades. Although several safety-enhancing tools are available, the pace of large-scale improvement remains slow, especially in developing countries such as China. The present project (Modern Surgery and Anesthesia Safety Management System Construction and Promotion) aims to develop and validate system-based integrated approaches for reducing perioperative deaths and complications using a multicentre, multistage design. The project involves collection of clinical and outcome information for 1 20 000 surgical inpatients at four regionally representative academic/teaching general hospitals in China during three sequential stages: preparation and development, effectiveness validation and improvement of implementation for promotion. These big data will provide the evidence base for the formulation, validation and improvement processes of a system-based stratified safety intervention package covering the entire surgical pathway. Attention will be directed to managing inherent patient risks and regulating medical safety behaviour. Information technology will facilitate data collection and intervention implementation, provide supervision mechanisms and guarantee transfer of key patient safety messages between departments and personnel. Changes in rates of deaths, surgical complications during hospitalisation, length of stay, system adoption and implementation rates will be analysed to evaluate effectiveness and efficiency. This study was approved by the institutional review boards of Peking Union Medical College Hospital, First Hospital of China Medical University, Qinghai Provincial People's Hospital, Xiangya Hospital Central South University and the Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences. Study findings will be disseminated via peer-reviewed journals, conference presentations and patent papers. © 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.

  16. Radiation Protection, Safety and Security Issues in Ghana.

    PubMed

    Boadu, Mary; Emi-Reynolds, Geoffrey; Amoako, Joseph Kwabena; Akrobortu, Emmanuel; Hasford, Francis

    2016-11-01

    Although the use of radioisotopes in Ghana began in 1952, the Radiation Protection Board of Ghana was established in 1993 and served as the national competent authority for authorization and inspection of practices and activities involving radiation sources until 2015. The law has been superseded by an Act of Parliament, Act 895 of 2015, mandating the Nuclear Regulatory Authority of Ghana to take charge of the regulation of radiation sources and their applications. The Radiation Protection Institute in Ghana provided technical support to the regulatory authority. Regulatory and service activities that were undertaken by the Institute include issuance of permits for handling of a radiation sources, authorization and inspection of radiation sources, radiation safety assessment, safety assessment of cellular signal towers, and calibration of radiation-emitting equipment. Practices and activities involving application of radiation are brought under regulatory control in the country through supervision by the national competent authority.

  17. Minimizing treatment planning errors in proton therapy using failure mode and effects analysis.

    PubMed

    Zheng, Yuanshui; Johnson, Randall; Larson, Gary

    2016-06-01

    Failure mode and effects analysis (FMEA) is a widely used tool to evaluate safety or reliability in conventional photon radiation therapy. However, reports about FMEA application in proton therapy are scarce. The purpose of this study is to apply FMEA in safety improvement of proton treatment planning at their center. The authors performed an FMEA analysis of their proton therapy treatment planning process using uniform scanning proton beams. The authors identified possible failure modes in various planning processes, including image fusion, contouring, beam arrangement, dose calculation, plan export, documents, billing, and so on. For each error, the authors estimated the frequency of occurrence, the likelihood of being undetected, and the severity of the error if it went undetected and calculated the risk priority number (RPN). The FMEA results were used to design their quality management program. In addition, the authors created a database to track the identified dosimetric errors. Periodically, the authors reevaluated the risk of errors by reviewing the internal error database and improved their quality assurance program as needed. In total, the authors identified over 36 possible treatment planning related failure modes and estimated the associated occurrence, detectability, and severity to calculate the overall risk priority number. Based on the FMEA, the authors implemented various safety improvement procedures into their practice, such as education, peer review, and automatic check tools. The ongoing error tracking database provided realistic data on the frequency of occurrence with which to reevaluate the RPNs for various failure modes. The FMEA technique provides a systematic method for identifying and evaluating potential errors in proton treatment planning before they result in an error in patient dose delivery. The application of FMEA framework and the implementation of an ongoing error tracking system at their clinic have proven to be useful in error reduction in proton treatment planning, thus improving the effectiveness and safety of proton therapy.

  18. Impacts of Bicycle Infrastructure in Mid-Sized Cities (IBIMS): protocol for a natural experiment study in three Canadian cities.

    PubMed

    Winters, Meghan; Branion-Calles, Michael; Therrien, Suzanne; Fuller, Daniel; Gauvin, Lise; Whitehurst, David G T; Nelson, Trisalyn

    2018-01-21

    Bicycling is promoted as a transportation and population health strategy globally. Yet bicycling has low uptake in North America (1%-2% of trips) compared with European bicycling cities (15%-40% of trips) and shows marked sex and age trends. Safety concerns due to collisions with motor vehicles are primary barriers.To attract the broader population to bicycling, many cities are making investments in bicycle infrastructure. These interventions hold promise for improving population health given the potential for increased physical activity and improved safety, but such outcomes have been largely unstudied. In 2016, the City of Victoria, Canada, committed to build a connected network of infrastructure that separates bicycles from motor vehicles, designed to attract people of 'all ages and abilities' to bicycling.This natural experiment study examines the impacts of the City of Victoria's investment in a bicycle network on active travel and safety outcomes. The specific objectives are to (1) estimate changes in active travel, perceived safety and bicycle safety incidents; (2) analyse spatial inequities in access to bicycle infrastructure and safety incidents; and (3) assess health-related economic benefits. The study is in three Canadian cities (intervention: Victoria; comparison: Kelowna, Halifax). We will administer population-based surveys in 2016, 2018 and 2021 (1000 people/city). The primary outcome is the proportion of people reporting bicycling. Secondary outcomes are perceived safety and bicycle safety incidents. Spatial analyses will compare the distribution of bicycle infrastructure and bicycle safety incidents across neighbourhoods and across time. We will also calculate the economic benefits of bicycling using WHO's Health Economic Assessment Tool. This study received approval from the Simon Fraser University Office of Research Ethics (study no. 2016s0401). Findings will be disseminated via a website, presentations to stakeholders, at academic conferences and through peer-reviewed journal articles. © 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 expressly granted.

  19. Lawn Care Pesticides. Risks Remain Uncertain While Prohibited Safety Claims Continue

    DTIC Science & Technology

    1990-03-23

    Trade Commission (FrC), under its own legislative authority to protect consumers against false and deceptive advertising , can take enforcement action...vides to the public about the safety of its products, federal enforcement actions taken against lawn care pesticide safety advertising claims, and...in reassessing the risks of these pesticides. FIFRA also authorizes EPA to take enforcement action against advertising claims made by pesticide

  20. Transsexualism and Flight Safety

    DTIC Science & Technology

    1987-05-08

    Security Classification) Transsexualism and Flight Safety 12. PERSONAL AUTHOR(S) Clements, Thomas I. and Wicks, Roland E. 13a. TYPE OF REPORT 13b. TIME... transsexual pilot with questionable judgment affecting flight safety is reported. The definition, etiology, and presenting symptoms are discussed. Three...involve all the phases of therapy and can be significant. Though the transsexual tends to have more episodes of anxiety and depression than the norm

  1. 47 CFR 80.1103 - Equipment authorization.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Equipment authorization. 80.1103 Section 80.1103 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Global Maritime Distress and Safety System (GMDSS) Equipment Requirements...

  2. 47 CFR 80.1103 - Equipment authorization.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 5 2014-10-01 2014-10-01 false Equipment authorization. 80.1103 Section 80.1103 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Global Maritime Distress and Safety System (GMDSS) Equipment Requirements...

  3. 47 CFR 80.1103 - Equipment authorization.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Equipment authorization. 80.1103 Section 80.1103 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Global Maritime Distress and Safety System (GMDSS) Equipment Requirements...

  4. 47 CFR 80.1103 - Equipment authorization.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 5 2013-10-01 2013-10-01 false Equipment authorization. 80.1103 Section 80.1103 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Global Maritime Distress and Safety System (GMDSS) Equipment Requirements...

  5. Teaching cultural safety in a New Zealand nursing education program.

    PubMed

    Richardson, Fran; Carryer, Jenny

    2005-05-01

    Cultural safety education is a concept unique to nursing in New Zealand. It involves teaching nursing students to recognize and understand the dynamics of cultural, personal, and professional power and how these shape nursing and health care relationships. This article describes the findings of a research study on the experience of teaching cultural safety. As a teacher of cultural safety, the first author was interested in exploring the experience of teaching the topic with other cultural safety teachers. A qualitative approach situated in a critical theory paradigm was used for the study. The study was informed by the ideas of Foucault and feminist theory. Fourteen women between ages 20 and 60 were interviewed about their experience of teaching cultural safety. Five women were Maori (the indigenous people of New Zealand), and 9 were Pakeha (the Maori name for New Zealanders of European descent). Following data analysis, three major themes were identified: that the Treaty of Waitangi provides for an examination of power in cultural safety education; that the broad concept of difference influences the experience of teaching cultural safety; and that the experience of teaching cultural safety has personal, professional, and political dimensions. These dimensions are experienced differently by Maori and Pakeha teachers.

  6. Towards an Inclusive Occupational Health and Safety For Informal Workers.

    PubMed

    Lund, Francie; Alfers, Laura; Santana, Vilma

    2016-08-01

    Large numbers of workers worldwide work informally. Yet the discipline and practice of occupational health and safety covers largely only formal workers, in formal work places. A comprehensive approach would have to take into account specific hazards faced by those in different occupations, working in "atypical" work places. Local authorities exert significant influence in the provision of infrastructure that impacts on health and safety, such as water and sanitation. Examples from Brazil and Ghana show that positive interventions are possible so long as informal workers are recognized as contributing to the economy. A more inclusive occupational health and safety is most likely to happen in contexts where informal workers have an organized voice and where there are responsive health and safety personnel who understand that the world of work has changed. Some policy interventions that impact on healthy and safe work will need to involve multiple stakeholders and institutions. © The Author(s) 2016.

  7. Highway Safety Program Manual: Volume 3: Motorcycle Safety.

    ERIC Educational Resources Information Center

    National Highway Traffic Safety Administration (DOT), Washington, DC.

    Volume 3 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on aspects of motorcycle safety. The purpose and specific objectives of a State motorcycle safety program are outlined. Federal authority in the highway safety area and general policies…

  8. Safety of disease-modifying drugs for multiple sclerosis in pregnancy: current challenges and future considerations for effective pharmacovigilance.

    PubMed

    Lu, Ellen; Wang, Bing Wei; Guimond, Colleen; Synnes, Anne; Sadovnick, A Dessa; Dahlgren, Leanne; Traboulsee, Anthony; Tremlett, Helen

    2013-03-01

    When contemplating a pregnancy, women treated for multiple sclerosis (MS) with a disease-modifying drug must decide to discontinue their medication before conception or risk exposing their unborn child to potential drug toxicity. Few studies exist as reference for patients and physicians, and of those available, the majority are less than ideal due to real-world constraints, ethical issues and methodological shortcomings. The authors provide a brief summary of existing animal and human data with current recommendations regarding the safety of IFN-β, glatiramer acetate, natalizumab, mitoxantrone, fingolimod and teriflunomide during pregnancy and lactation in women with MS. We also assess the quality, strengths and limitations of the existing studies including challenges with study design. The investigation of outcomes such as spontaneous abortion and congenital anomalies are highlighted with potential methodological improvements for future studies on drug safety in pregnancy suggested. The authors explore the pharmacokinetics and pharmacodynamics of the MS disease-modifying drugs for their possible mechanistic role in fetal harm and discuss the potential role of clinical trials. Future pharmacovigilance studies should continue to pursue multicenter collaboration with an emphasis on appropriate study design.

  9. The swine flu vaccine, public attitudes, and researcher interpretations: a systematic review of qualitative research.

    PubMed

    Carlsen, Benedicte; Glenton, Claire

    2016-06-24

    During pandemics, health authorities may be uncertain about the spread and severity of the disease and the effectiveness and safety of available interventions. This was the case during the swine flu (H1N1) pandemic of 2009-2010, and governments were forced to make decisions despite these uncertainties. While many countries chose to implement wide scale vaccination programmes, few accomplished their vaccination goals. Many research studies aiming to explore barriers and facilitators to vaccine uptake have been conducted in the aftermath of the pandemic, including several qualitative studies. 1. To explore public attitudes to the swine flu vaccine in different countries through a review of qualitative primary studies. 2. To describe and discuss the implications drawn by the primary study authors. Systematic review of qualitative research studies, using a broadly comparative cross case-study approach. Study quality was appraised using an adaptation of the Critical Appraisal Skills Programme (CASP) quality assessment tool. The review indicates that the public had varying opinions about disease risk and prevalence and had concerns about vaccine safety. Most primary study authors concluded that participants were uninformed, and that more information about the disease and the vaccine would have led to an increase in vaccine uptake. We find these conclusions problematic. We suggest instead that people's questions and concerns were legitimate given the uncertainties of the situation at the time and the fact that the authorities did not have the necessary information to convince the public. Our quality assessment of the included studies points to a lack of reflexivity and a lack of information about study context. We suggest that these study weaknesses are tied to primary study authors' lack of acknowledgement of the uncertainties surrounding the disease and the vaccine. While primary study authors suggest that authorities could increase vaccine uptake through increased information, we suggest instead that health authorities should be more transparent in their information and decision-making processes in future pandemic situations.

  10. [Biomedical foundation for human safety in aviation].

    PubMed

    Ushakov, I B

    2004-01-01

    According to the author, preventive medical issues of providing human safety in aviation are related to the fundamental biomedical and socio-psychological problems of human beings in the present-day world. Factual material for analysis was compiled in the study performed at the State Research and Test Institute of Military Medicine. Outlined are main vectors of the future attack on the problem.

  11. Federal inventory of energy-related biomedical and environmental research for FY 1974 and FY 1975. [TVA, NASA, National Institutes of Health, National Institute for Occupational Safety and Health

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Not Available

    1975-10-01

    Brief summaries are presented of energy-related biomedical and environmental research studies during 1974 and 1975 sponsored by the Tennessee Valley Authority, National Aeronautics and Space Administration, National Institutes of Health, and the National Institute for Occupational Safety and Health. (CH)

  12. 49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Evaluation Criteria for Mexico-Domiciled Motor Carriers A Appendix A to Subpart E of Part 365 Transportation... OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers Pt. 365, Subpt. E, App. A Appendix A to Subpart E of Part 365—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico...

  13. 49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Evaluation Criteria for Mexico-Domiciled Motor Carriers A Appendix A to Subpart E of Part 365 Transportation... OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers Pt. 365, Subpt. E, App. A Appendix A to Subpart E of Part 365—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico...

  14. 49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Evaluation Criteria for Mexico-Domiciled Motor Carriers A Appendix A to Subpart E of Part 365 Transportation... OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers Pt. 365, Subpt. E, App. A Appendix A to Subpart E of Part 365—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico...

  15. 49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Evaluation Criteria for Mexico-Domiciled Motor Carriers A Appendix A to Subpart E of Part 365 Transportation... OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers Pt. 365, Subpt. E, App. A Appendix A to Subpart E of Part 365—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico...

  16. 49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Evaluation Criteria for Mexico-Domiciled Motor Carriers A Appendix A to Subpart E of Part 365 Transportation... OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers Pt. 365, Subpt. E, App. A Appendix A to Subpart E of Part 365—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico...

  17. 49 CFR 1.53 - Delegations to the Administrator of the Pipeline and Hazardous Materials Safety Administration.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... following: (a) Pipelines. (1) Exercise the authority and carry out the functions vested in the Secretary by the Federal pipeline safety laws (49 U.S.C. 60101 et seq.). (2) Exercise the authority and carry out....C. 185). (3) Exercise the authority and carry out the functions vested in the Secretary under...

  18. 49 CFR 1.53 - Delegations to the Administrator of the Pipeline and Hazardous Materials Safety Administration.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... following: (a) Pipelines. (1) Exercise the authority and carry out the functions vested in the Secretary by the Federal pipeline safety laws (49 U.S.C. 60101 et seq.). (2) Exercise the authority and carry out....C. 185). (3) Exercise the authority and carry out the functions vested in the Secretary under...

  19. Patient safety climate in general public hospitals in China: differences associated with department and job type based on a cross-sectional survey.

    PubMed

    Zhou, Ping; Bai, Fei; Tang, Hui-Qin; Bai, Jie; Li, Min-Qi; Xue, Di

    2018-04-17

    This study analysed differences in the perceived patient safety climate among different working departments and job types in public general hospitals in China. Cross-sectional survey. Eighteen tertiary hospitals and 36 secondary hospitals from 10 areas in Shanghai, Hubei Province and Gansu Province, China. Overall, 4753 staff, including physicians, nurses, medical technicians and managers, were recruited from March to June 2015. The Patient Safety Climate in Healthcare Organisations (PSCHO) tool and the percentages of 'problematic responses' (PPRs) were used as outcome measures. Multivariable two-level random intercept models were applied in the analysis. A total of 4121 valid questionnaires were collected. Perceptions regarding the patient safety climate varied among departments and job types. Physicians responded with relatively more negative evaluations of 'organisational resources for safety', 'unit recognition and support for safety efforts', 'psychological safety', 'problem responsiveness' and overall safety climate. Paediatrics departments, intensive care units, emergency departments and clinical auxiliary departments require more attention. The PPRs for 'fear of blame and punishment' were universally significantly high, and the PPRs for 'fear of shame' and 'provision of safe care' were remarkably high, especially in some departments. Departmental differences across all dimensions and the overall safety climate primarily depended on job type. The differences suggest that strategies and measures for improving the patient safety climate should be tailored by working department and job type. © 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 expressly granted.

  20. Strengths, weaknesses and future challenges of biosimilars' development. An opinion on how to improve the knowledge and use of biosimilars in clinical practice.

    PubMed

    Scavone, Cristina; Rafaniello, Concetta; Berrino, Liberato; Rossi, Francesco; Capuano, Annalisa

    2017-12-01

    Biosimilars started receiving the marketing authorization by European Medicine Agency since 2006. The development of biosimilars follows a well-defined step-wise approach, the so-called comparability exercise, which aims to compare non-clinical (mainly quality features and biological activity) and clinical (efficacy and safety profiles) features of new biosimilars with their respective reference products. Despite the undeniable advantages of such procedure, some concerns (such as the absence of switching studies or the evaluation of efficacy and safety in all therapeutic indications) still exist about its. In particular, the European regulatory framework on biosimilars approval does not include the conduction of switching studies demonstrating the interchangeability to be carried out before marketing authorization. This is one of the main aspects that negatively affects healthcare professionals' clinical decisions on switch. In order to achieve a better knowledge on safety and efficacy of biosimilar drugs, real world data should be collected and post-marketing efficacy and safety clinical studies (including those evaluating specific endpoints, therapeutic regimens and patients population), should be planned. also the conduction of well-designed switching studies is highly advisable, especially in the case of biosimilar drugs used in oncology settings. Lastly, considering the critical role of antidrug antibodies on efficacy/safety profile of biologic drugs, studies based on therapeutic drug monitoring would be useful in order to achieve treatment optimization. Implementing the above strategies could be helpful to fill the gap in knowledge observed in the present European biosimilar regulatory framework. Copyright © 2017 Elsevier Ltd. All rights reserved.

  1. Using resources for scientific-driven pharmacovigilance: from many product safety documents to one product safety master file.

    PubMed

    Furlan, Giovanni

    2012-08-01

    Current regulations require a description of the overall safety profile or the specific risks of a drug in multiple documents such as the Periodic and Development Safety Update Reports, Risk Management Plans (RMPs) and Signal Detection Reports. In a resource-constrained world, the need for preparing multiple documents reporting the same information results in shifting the focus from a thorough scientific and medical evaluation of the available data to maintaining compliance with regulatory timelines. Since the aim of drug safety is to understand and characterize product issues to take adequate risk minimization measures rather than to comply with bureaucratic requirements, there is the need to avoid redundancy. In order to identify core drug safety activities that need to be undertaken to protect patient safety and reduce the number of documents reporting the results of these activities, the author has reviewed the main topics included in the drug safety guidelines and templates. The topics and sources that need to be taken into account in the main regulatory documents have been found to greatly overlap and, in the future, as a result of the new Periodic Safety Update Report structure and requirements, in the author's opinion this overlap is likely to further increase. Many of the identified inter-document differences seemed to be substantially formal. The Development Safety Update Report, for example, requires separate presentation of the safety issues emerging from different sources followed by an overall evaluation of each safety issue. The RMP, instead, requires a detailed description of the safety issues without separate presentation of the evidence derived from each source. To some extent, however, the individual documents require an in-depth analysis of different aspects; the RMP, for example, requires an epidemiological description of the indication for which the drug is used and its risks. At the time of writing this article, this is not specifically required by other documents. The author has identified signal detection (intended not only as adverse event disproportionate reporting, but including non-clinical, laboratory, clinical analysis data and literature screening) and characterization as the basis for the preparation of all drug safety documents, which can be viewed as different ways of presenting the results of this activity. Therefore, the author proposes to merge all the aggregate reports required by current regulations into a single document - the Drug Safety Master File. This report should contain all the available information, from any source, regarding the potential and identified risks of a drug. It should be a living document updated and submitted to regulatory authorities on an ongoing basis.

  2. Qualification of Simulation Software for Safety Assessment of Sodium Cooled Fast Reactors. Requirements and Recommendations

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Brown, Nicholas R.; Pointer, William David; Sieger, Matt

    2016-04-01

    The goal of this review is to enable application of codes or software packages for safety assessment of advanced sodium-cooled fast reactor (SFR) designs. To address near-term programmatic needs, the authors have focused on two objectives. First, the authors have focused on identification of requirements for software QA that must be satisfied to enable the application of software to future safety analyses. Second, the authors have collected best practices applied by other code development teams to minimize cost and time of initial code qualification activities and to recommend a path to the stated goal.

  3. The dental safety net in Connecticut.

    PubMed

    Beazoglou, Tryfon; Heffley, Dennis; Lepowsky, Steven; Douglass, Joanna; Lopez, Monica; Bailit, Howard

    2005-10-01

    Many poor, medically disabled and geographically isolated populations have difficulty accessing private-sector dental care and are considered underserved. To address this problem, public- and voluntary-sector organizations have established clinics and provide care to the underserved. Collectively, these clinics are known as "the dental safety net." The authors describe the dental safety net in Connecticut and examine the capacity and efficiency of this system to provide care to the noninstitutionalized underserved population of the state. The authors describe Connecticut's dental safety net in terms of dentists, allied health staff members, operatories, patient visits and patients treated per dentist per year. The authors compare the productivity of safety-net dentists with that of private practitioners. They also estimate the capacity of the safety net to treat people enrolled in Medicaid and the State Children's Health Insurance Program. The safety net is made up of dental clinics in community health centers, hospitals, the dental school and public schools. One hundred eleven dentists, 38 hygienists and 95 dental assistants staff the clinics. Safety-net dentists have fewer patient visits and patients than do private practitioners. The Connecticut safety-net system has the capacity to treat about 28.2 percent of publicly insured patients. The dental safety net is an important community resource, and greater use of allied dental personnel could substantially improve the capacity of the system to care for the poor and other underserved populations.

  4. Safety Education--An Essential Element of Technical Training

    ERIC Educational Resources Information Center

    Glazener, Everett R.; Comstock, Thomas W.

    1978-01-01

    After tracing the background of the safety movement, provisions of recent safety legislation, and the ecological and environmental impact of industrial processes, the author stresses the need for safety education in technical education programs to prepare future employees for industrial safety requirements. (MF)

  5. Safety assessment of Vitis vinifera (grape)-derived ingredients as used in cosmetics.

    PubMed

    Fiume, Monice M; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

    2014-01-01

    The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of 24 Vitis vinifera (grape)-derived ingredients and found them safe in the present practices of use and concentration in cosmetics. These ingredients function in cosmetics mostly as skin-conditioning agents, but some function as antioxidants, flavoring agents, and/or colorants. The Panel reviewed the available animal and clinical data to determine the safety of these ingredients. Additionally, some constituents of grapes have been assessed previously for safety as cosmetic ingredients by the Panel, and others are compounds that have been discussed in previous Panel safety assessments. © The Author(s) 2014.

  6. Safety climate in university and college laboratories: impact of organizational and individual factors.

    PubMed

    Wu, Tsung-Chih; Liu, Chi-Wei; Lu, Mu-Chen

    2007-01-01

    Universities and colleges serve to be institutions of education excellence; however, problems in the areas of occupational safety may undermine such goals. Occupational safety must be the concern of every employee in the organization, regardless of job position. Safety climate surveys have been suggested as important tools for measuring the effectiveness and improvement direction of safety programs. Thus, this study aims to investigate the influence of organizational and individual factors on safety climate in university and college laboratories. Employees at 100 universities and colleges in Taiwan were mailed a self-administered questionnaire survey; the response rate was 78%. Multivariate analysis of variance revealed that organizational category of ownership, the presence of a safety manager and safety committee, gender, age, title, accident experience, and safety training significantly affected the climate. Among them, accident experience and safety training affected the climate with practical significance. The authors recommend that managers should address important factors affecting safety issues and then create a positive climate by enforcing continuous improvements.

  7. Determinants of clergy behaviors promoting safety of battered Korean immigrant women.

    PubMed

    Choi, Y Joon

    2015-03-01

    Korean immigrants rely heavily on their respective churches for assistance with domestic violence. Yet, Korean clergy's responses to domestic violence are unknown. The purpose of this study was to examine factors that influence Korean clergy's responses to domestic violence in their congregations. Results showed that clergy's Korean cultural values, age, and length of residence in the United States influence their responses to domestic violence. Developing a collaborative working relationship between Korean clergy and domestic violence advocates, as well as providing training to Korean clergy targeting their knowledge, beliefs/attitudes, and skills is critical for promoting safety of battered Korean immigrant women. © The Author(s) 2015.

  8. Long-Term Safety of Textured and Smooth Breast Implants.

    PubMed

    Calobrace, M Bradley; Schwartz, Michael R; Zeidler, Kamakshi R; Pittman, Troy A; Cohen, Robert; Stevens, W Grant

    2017-12-13

    In this review, the authors provide a 20-year review and comparison of implant options and describe the evolution of breast implant surface textures; compare available implant surfaces; present long-term safety data from the 10-year US-based Core clinical studies; list the key benefits and risks associated with smooth and textured implants; and provide perspectives on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The authors explore the key benefits and risks associated with all available devices so that optimal and safe patient outcomes can be achieved. © 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

  9. A profile of fatal accidents involving alcohol

    DOT National Transportation Integrated Search

    1977-09-01

    Author's abstract: Accident investigation studies were conducted during 1971-75 in the cities of Boston, Baltimore, Oklahoma City and Albuquerque where Alcohol Safety Action Programs (ASAPs) were operating. Analysis of the four studies, plus newly av...

  10. 49 CFR 800.25 - Delegation to the Directors of Office of Aviation Safety, Office of Railroad Safety, Office of...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 7 2012-10-01 2012-10-01 false Delegation to the Directors of Office of Aviation... Office of Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety... Offices of Aviation, Railroad, Highway, Marine, and Pipeline and Hazardous Materials Safety, the authority...

  11. 49 CFR 800.25 - Delegation to the Directors of Office of Aviation Safety, Office of Railroad Safety, Office of...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 7 2014-10-01 2014-10-01 false Delegation to the Directors of Office of Aviation... Office of Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety... Offices of Aviation, Railroad, Highway, Marine, and Pipeline and Hazardous Materials Safety, the authority...

  12. 49 CFR 800.25 - Delegation to the Directors of Office of Aviation Safety, Office of Railroad Safety, Office of...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 7 2013-10-01 2013-10-01 false Delegation to the Directors of Office of Aviation... Office of Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety... Offices of Aviation, Railroad, Highway, Marine, and Pipeline and Hazardous Materials Safety, the authority...

  13. 49 CFR 800.25 - Delegation to the Directors of Office of Aviation Safety, Office of Railroad Safety, Office of...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 7 2011-10-01 2011-10-01 false Delegation to the Directors of Office of Aviation... Office of Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety... Offices of Aviation, Railroad, Highway, Marine, and Pipeline and Hazardous Materials Safety, the authority...

  14. 49 CFR 800.25 - Delegation to the Directors of Office of Aviation Safety, Office of Railroad Safety, Office of...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Office of Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety... Offices of Aviation, Railroad, Highway, Marine, and Pipeline and Hazardous Materials Safety, the authority... 49 Transportation 7 2010-10-01 2010-10-01 false Delegation to the Directors of Office of Aviation...

  15. 10 CFR 820.61 - Secretarial officer.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... environment, safety and health matters shall exercise this authority with respect to provisions relating to radiological protection of workers, the public and the environment. This authority may not be further delegated. ... Safety Requirement relates may grant a temporary or permanent exemption from that requirement as...

  16. 10 CFR 820.61 - Secretarial officer.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... environment, safety and health matters shall exercise this authority with respect to provisions relating to radiological protection of workers, the public and the environment. This authority may not be further delegated. ... Safety Requirement relates may grant a temporary or permanent exemption from that requirement as...

  17. 10 CFR 820.61 - Secretarial officer.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... environment, safety and health matters shall exercise this authority with respect to provisions relating to radiological protection of workers, the public and the environment. This authority may not be further delegated. ... Safety Requirement relates may grant a temporary or permanent exemption from that requirement as...

  18. 10 CFR 820.61 - Secretarial officer.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... environment, safety and health matters shall exercise this authority with respect to provisions relating to radiological protection of workers, the public and the environment. This authority may not be further delegated. ... Safety Requirement relates may grant a temporary or permanent exemption from that requirement as...

  19. 10 CFR 820.61 - Secretarial officer.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... environment, safety and health matters shall exercise this authority with respect to provisions relating to radiological protection of workers, the public and the environment. This authority may not be further delegated. ... Safety Requirement relates may grant a temporary or permanent exemption from that requirement as...

  20. 29 CFR 1952.125 - Changes to approved plans.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR..., concerning an internal occupational safety and health program on the Colville reservation. Under this... authority set forth in its State plan. (Federal OSHA will exercise enforcement authority over Indian-owned...

  1. 29 CFR 1952.125 - Changes to approved plans.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR..., concerning an internal occupational safety and health program on the Colville reservation. Under this... authority set forth in its State plan. (Federal OSHA will exercise enforcement authority over Indian-owned...

  2. 49 CFR 392.9a - Operating authority.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false Operating authority. 392.9a Section 392.9a Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS DRIVING OF COMMERCIAL MOTOR...

  3. 75 FR 63774 - Pipeline Safety: Safety of On-Shore Hazardous Liquid Pipelines

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-18

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part... Pipelines AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of... Gas Pipeline Safety Act of 1968, Public Law 90-481, delegated to DOT the authority to develop...

  4. 48 CFR 923.7001 - Nuclear safety.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Nuclear safety. 923.7001... Efficiency, Renewable Energy Technologies, and Occupational Safety Programs 923.7001 Nuclear safety. The DOE regulates the nuclear safety of its major facilities under its own statutory authority derived from the...

  5. Differences in Hospital Managers', Unit Managers', and Health Care Workers' Perceptions of the Safety Climate for Respiratory Protection.

    PubMed

    Peterson, Kristina; Rogers, Bonnie M E; Brosseau, Lisa M; Payne, Julianne; Cooney, Jennifer; Joe, Lauren; Novak, Debra

    2016-07-01

    This article compares hospital managers' (HM), unit managers' (UM), and health care workers' (HCW) perceptions of respiratory protection safety climate in acute care hospitals. The article is based on survey responses from 215 HMs, 245 UMs, and 1,105 HCWs employed by 98 acute care hospitals in six states. Ten survey questions assessed five of the key dimensions of safety climate commonly identified in the literature: managerial commitment to safety, management feedback on safety procedures, coworkers' safety norms, worker involvement, and worker safety training. Clinically and statistically significant differences were found across the three respondent types. HCWs had less positive perceptions of management commitment, worker involvement, and safety training aspects of safety climate than HMs and UMs. UMs had more positive perceptions of management's supervision of HCWs' respiratory protection practices. Implications for practice improvements indicate the need for frontline HCWs' inclusion in efforts to reduce safety climate barriers and better support effective respiratory protection programs and daily health protection practices. © 2016 The Author(s).

  6. The Effects of Caffeine Use on Driving Safety Among Truck Drivers Who Are Habitual Caffeine Users.

    PubMed

    Heaton, Karen; Griffin, Russell

    2015-08-01

    The purpose of this study was to describe caffeine use among a group of habitual caffeine users, truck drivers, and to explore the associations between caffeine use and critical safety events by age in the naturalistic work setting. A secondary analysis of existing data from the Naturalistic Truck Driving Study was conducted. Analyses focused on the association between sleep and caffeine consumption by duty status, comparisons of sleep and caffeine use by age, and the associations between caffeine use and safety-critical events (SCEs). Findings indicated differences in caffeine use by duty status. However, no difference in sleep time by duty status, or between sleep time and caffeine use was found regardless of when the caffeine was consumed during the 5 hours prior to sleep. Sleep time did not vary significantly by age, although increasing age was associated with decreased caffeine use. Overall, a 6% reduction in the rate of SCEs per eight ounces of caffeinated beverage consumed was found. This study makes a unique scientific contribution because it uses real-time observations of truckers in the naturalistic work setting. It also does not involve caffeine withdrawal but rather an investigation of the effects of the naturalistic consumption of caffeine on sleep and driving performance. Findings suggest that caffeine use among habitual users offers a protective effect for safety-critical driving events. Occupational health nurses may use this information to counsel workers in the use of caffeine to enhance driving safety. © 2015 The Author(s).

  7. Specialist Cohort Event Monitoring studies: a new study method for risk management in pharmacovigilance.

    PubMed

    Layton, Deborah; Shakir, Saad A W

    2015-02-01

    The evolving regulatory landscape has heightened the need for innovative, proactive, efficient and more meaningful solutions for 'real-world' post-authorization safety studies (PASS) that not only align with risk management objectives to gather additional safety monitoring information or assess a pattern of drug utilization, but also satisfy key regulatory requirements for marketing authorization holder risk management planning and execution needs. There is a need for data capture across the primary care and secondary care interface, or for exploring use of new medicines in secondary care to support conducting PASS. To fulfil this need, event monitoring has evolved. The Specialist Cohort Event Monitoring (SCEM) study is a new application that enables a cohort of patients prescribed a medicine in the hospital and secondary care settings to be monitored. The method also permits the inclusion of a comparator cohort of patients receiving standard care, or another counterfactual comparator group, to be monitored concurrently, depending on the study question. The approach has been developed in parallel with the new legislative requirement for pharmaceutical companies to undertake a risk management plan as part of post-authorization safety monitoring. SCEM studies recognize that the study population comprises those patients who may have treatment initiated under the care of specialist health care professionals and who are more complex in terms of underlying disease, co-morbidities and concomitant medications than the general disease population treated in primary care. The aims of this paper are to discuss the SCEM new-user study design, rationale and features that aim to address possible bias (such as selection bias) and current applications.

  8. What can patients tell us about the quality and safety of hospital care? Findings from a UK multicentre survey study.

    PubMed

    O'Hara, Jane K; Reynolds, Caroline; Moore, Sally; Armitage, Gerry; Sheard, Laura; Marsh, Claire; Watt, Ian; Wright, John; Lawton, Rebecca

    2018-03-15

    Patient safety measurement remains a global challenge. Patients are an important but neglected source of learning; however, little is known about what patients can add to our understanding of safety. We sought to understand the incidence and nature of patient-reported safety concerns in hospital. Feedback about the experience of safety within hospital was gathered from 2471 inpatients as part of a multicentre, waitlist cluster randomised controlled trial of an intervention, undertaken within 33 wards across three English NHS Trusts, between May 2013 and September 2014. Patient volunteers, supported by researchers, developed a classification framework of patient-reported safety concerns from a random sample of 231 reports. All reports were then classified using the patient-developed categories. Following this, all patient-reported safety concerns underwent a two-stage clinical review process for identification of patient safety incidents. Of the 2471 inpatients recruited, 579 provided 1155 patient-reported incident reports. 14 categories were developed for classification of reports, with communication the most frequently occurring (22%), followed by staffing issues (13%) and problems with the care environment (12%). 406 of the total 1155 patient incident reports (35%) were classified by clinicians as a patient safety incident according to the standard definition. 1 in 10 patients (264 patients) identified a patient safety incident, with medication errors the most frequently reported incident. Our findings suggest that patients can provide insight about safety that complements existing patient safety measurement, with a frequency of reported patient safety incidents that is similar to those obtained via case note review. However, patients provide a unique perspective about hospital safety which differs from and adds to current definitions of patient safety incidents. ISRCTN07689702; pre-results. © 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.

  9. Sensemaking and the co-production of safety: a qualitative study of primary medical care patients.

    PubMed

    Rhodes, Penny; McDonald, Ruth; Campbell, Stephen; Daker-White, Gavin; Sanders, Caroline

    2016-02-01

    This study explores the ways in which patients make sense of 'safety' in the context of primary medical care. Drawing on qualitative interviews with primary care patients, we reveal patients' conceptualisation of safety as fluid, contingent, multi-dimensional, and negotiated. Participant accounts drew attention to a largely invisible and inaccessible (but taken for granted) architecture of safety, the importance of psycho-social as well as physical dimensions and the interactions between them, informal strategies for negotiating safety, and the moral dimension of safety. Participants reported being proactive in taking action to protect themselves from potential harm. The somewhat routinised and predictable nature of the primary medical care consultation, which is very different from 'one off' inpatient spells, meant that patients were not passive recipients of care. Instead they had a stock of accumulated knowledge and experience to inform their actions. In addition to highlighting the differences and similarities between hospital and primary care settings, the study suggests that a broad conceptualisation of patient safety is required, which encompasses the safety concerns of patients in primary care settings. © 2015 The Authors. Sociology of Health & Illness published by John Wiley & Sons Ltd on behalf of Foundation for SHIL.

  10. Evolution of a holistic systems approach to planning and managing road safety: the Victorian case study, 1970-2015.

    PubMed

    Muir, Carlyn; Johnston, Ian R; Howard, Eric

    2018-06-01

    The Victorian Safe System approach to road safety slowly evolved from a combination of the Swedish Vision Zero philosophy and the Sustainable Safety model developed by the Dutch. The Safe System approach reframes the way in which road safety is viewed and managed. This paper presents a case study of the institutional change required to underpin the transformation to a holistic approach to planning and managing road safety in Victoria, Australia. The adoption and implementation of a Safe System approach require strong institutional leadership and close cooperation among all the key agencies involved, and Victoria was fortunate in that it had a long history of strong interagency mechanisms in place. However, the challenges in the implementation of the Safe System strategy in Victoria are generally neither technical nor scientific; they are predominantly social and political. While many governments purport to develop strategies based on Safe System thinking, on-the-ground action still very much depends on what politicians perceive to be publicly acceptable, and Victoria is no exception. This is a case study of the complexity of institutional change and is presented in the hope that the lessons may prove useful for others seeking to adopt more holistic planning and management of road safety. There is still much work to be done in Victoria, but the institutional cultural shift has taken root. Ongoing efforts must be continued to achieve alert and compliant road users; however, major underpinning benefits will be achieved through focusing on road network safety improvements (achieving forgiving infrastructure, such as wire rope barriers) in conjunction with reviews of posted speed limits (to be set in response to the level of protection offered by the road infrastructure) and by the progressive introduction into the fleet of modern vehicle safety features. © 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 expressly granted.

  11. Structural equation modeling of pesticide poisoning, depression, safety, and injury.

    PubMed

    Beseler, Cheryl L; Stallones, Lorann

    2013-01-01

    The role of pesticide poisoning in risk of injuries may operate through a link between pesticide-induced depressive symptoms and reduced engagement in safety behaviors. The authors conducted structural equation modeling of cross-sectional data to examine the pattern of associations between pesticide poisoning, depressive symptoms, safety knowledge, safety behaviors, and injury. Interviews of 1637 Colorado farm operators and their spouses from 964 farms were conducted during 1993-1997. Pesticide poisoning was assessed based on a history of ever having been poisoned. The Center for Epidemiologic Studies-Depression scale was used to assess depressive symptoms. Safety knowledge and safety behaviors were assessed using ten items for each latent variable. Outcomes were safety behaviors and injuries. A total of 154 injuries occurred among 1604 individuals with complete data. Pesticide poisoning, financial problems, health, and age predicted negative affect/somatic depressive symptoms with similar effect sizes; sex did not. Depression was more strongly associated with safety behavior than was safety knowledge. Two safety behaviors were significantly associated with an increased risk of injury. This study emphasizes the importance of financial problems and health on depression, and provides further evidence for the link between neurological effects of past pesticide poisoning on risk-taking behaviors and injury.

  12. Structural empowerment and patient safety culture among registered nurses working in adult critical care units.

    PubMed

    Armellino, Donna; Quinn Griffin, Mary T; Fitzpatrick, Joyce J

    2010-10-01

    The aim of the present study was to examine the relationship between structural empowerment and patient safety culture among staff level Registered Nurses (RNs) within adult critical care units (ACCU). There is literature to support the value of RNs' structurally empowered work environments and emerging literature towards patient safety culture; the link between empowerment and patient safety culture is being discovered. A sample of 257 RNs, working within adult critical care of a tertiary hospital in the United States, was surveyed. Instruments included a background data sheet, the Conditions of Workplace Effectiveness and the Hospital Survey on Patient Safety Culture. Structural empowerment and patient safety culture were significantly correlated. As structural empowerment increased so did the RNs' perception of patient safety culture. To foster patient safety culture, nurse leaders should consider providing structurally empowering work environments for RNs. This study contributes to the body of knowledge linking structural empowerment and patient safety culture. Results link structurally empowered RNs and increased patient safety culture, essential elements in delivering efficient, competent, quality care. They inform nursing management of key factors in the nurses' environment that promote safe patient care environments. © 2010 The Authors. Journal compilation © 2010 Blackwell Publishing Ltd.

  13. MICROBIOLOGICAL SAFETY BIBLIOGRAPHY

    DTIC Science & Technology

    More than a thousand articles on biological safety in infectious disease laboratories are listed for the use of supervisors responsible for the safety of laboratory personnel. An author index is included.

  14. 29 CFR 1926.1418 - Authority to stop operation.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 8 2011-07-01 2011-07-01 false Authority to stop operation. 1926.1418 Section 1926.1418 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Cranes and Derricks in...

  15. Bibliography on Liquefied Natural Gas (LNG) safety

    NASA Technical Reports Server (NTRS)

    Ordin, P. M.

    1976-01-01

    Approximately 600 citations concerning safety of liquefied natural gas and liquid methane are presented. Each entry includes the title, author, abstract, source, description of figures, key references, and major descriptors for retrieving the document. An author index is provided as well as an index of descriptors.

  16. 77 FR 1975 - Safety Advisory: Unauthorized Marking of Compressed Gas Cylinders

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-12

    ... Jackson Plaza, Ann Arbor, MI improperly requalified and marked high pressure compressed gas cylinders... DOT specification cylinders after its authority to requalifiy high pressure cylinders expired on... that Spears Fire & Safety continued to requalify and mark high pressure cylinders after their authority...

  17. Water safety in healthcare facilities. The Vieste Charter.

    PubMed

    Bonadonna, L; Cannarozzi de Grazia, M; Capolongo, S; Casini, B; Cristina, M L; Daniele, G; D'Alessandro, D; De Giglio, O; Di Benedetto, A; Di Vittorio, G; Ferretti, E; Frascolla, B; La Rosa, G; La Sala, L; Lopuzzo, M G; Lucentini, L; Montagna, M T; Moscato, U; Pasquarella, C; Prencipe, R; Ricci, M L; Romano Spica, V; Signorelli, C; Veschetti, E

    2017-01-01

    The Study Group on Hospital Hygiene of the Italian Society of Hygiene, Preventive Medicine and Public Health (GISIO-SItI) and the Local Health Authority of Foggia, Apulia, Italy, after the National Convention "Safe water in healthcare facilities" held in Vieste-Pugnochiuso on 27-28 May 2016, present the "Vieste Charter", drawn up in collaboration with experts from the National Institute of Health and the Ministry of Health. This paper considers the risk factors that may affect the water safety in healthcare facilities and reports the current regulatory frameworks governing the management of installations and the quality of the water. The Authors promote a careful analysis of the risks that characterize the health facilities, for the control of which specific actions are recommended in various areas, including water safety plans; approval of treatments; healthcare facilities responsibility, installation and maintenance of facilities; multidisciplinary approach; education and research; regional and national coordination; communication.

  18. The natural selection of organizational and safety culture within a small to medium sized enterprise (SME).

    PubMed

    Brooks, Benjamin

    2008-01-01

    Small to Medium Sized Enterprises (SMEs) form the majority of Australian businesses. This study uses ethnographic research methods to describe the organizational culture of a small furniture-manufacturing business in southern Australia. Results show a range of cultural assumptions variously 'embedded' within the enterprise. In line with memetics - Richard Dawkin's cultural application of Charles Darwin's theory of Evolution by Natural Selection, the author suggests that these assumptions compete to be replicated and retained within the organization. The author suggests that dominant assumptions are naturally selected, and that the selection can be better understood by considering the cultural assumptions in reference to Darwin's original principles and Frederik Barth's anthropological framework of knowledge. The results are discussed with reference to safety systems, negative cultural elements called Cultural Safety Viruses, and how our understanding of this particular organizational culture might be used to build resistance to these viruses.

  19. Communicating vaccine safety during the development and introduction of vaccines.

    PubMed

    Kochhar, Sonali

    2015-01-01

    Vaccines are the best defense available against infectious diseases. Vaccine safety is of major focus for regulatory bodies, vaccine manufacturers, public health authorities, health care providers and the public as vaccines are often given to healthy children and adults as well as to pregnant woman. Safety assessment is critical at all stages of vaccine development. Effective, clear and consistent communication of the risks and benefits of vaccines and advocacy during all stages of clinical research (including the preparation, approvals, conduct of clinical trials through the post marketing phase) is critically important. This needs to be done for all major stakeholders (e.g. community members, Study Team, Health Care Providers, Ministry of Health, Regulators, Ethics Committee members, Public Health Authorities and Policy Makers). Improved stakeholder alignment would help to address some of the concerns that may affect the clinical research, licensing of vaccines and their wide-spread use in immunization programs around the world.

  20. [Hygiene, safety and occupational medicine in Niger].

    PubMed

    Moussa, F; Sékou, H

    1997-01-01

    The laws and rules governing hygiene, safety and medicine in the workplace in Niger were evaluated in this study. We used labour administration, health service and Social Security Department reports to review each type of professional activity and the risks associated with it. This enabled us to make recommendations to the authorities and to the organizations representing employers and staff, concerning the prevention of risks at work.

  1. Effects of efforts to optimise morbidity and mortality rounds to serve contemporary quality improvement and educational goals: a systematic review.

    PubMed

    Smaggus, Andrew; Mrkobrada, Marko; Marson, Alanna; Appleton, Andrew

    2018-01-01

    The quality and safety movement has reinvigorated interest in optimising morbidity and mortality (M&M) rounds. We performed a systematic review to identify effective means of updating M&M rounds to (1) identify and address quality and safety issues, and (2) address contemporary educational goals. Relevant databases (Medline, Embase, PubMed, Education Resource Information Centre, Cumulative Index to Nursing and Allied Health Literature, Healthstar, and Global Health) were searched to identify primary sources. Studies were included if they (1) investigated an intervention applied to M&M rounds, (2) reported outcomes relevant to the identification of quality and safety issues, or educational outcomes relevant to quality improvement (QI), patient safety or general medical education and (3) included a control group. Study quality was assessed using the Medical Education Research Study Quality Instrument and Newcastle-Ottawa Scale-Education instruments. Given the heterogeneity of interventions and outcome measures, results were analysed thematically. The final analysis included 19 studies. We identified multiple effective strategies (updating objectives, standardising elements of rounds and attaching rounds to a formal quality committee) to optimise M&M rounds for a QI/safety purpose. These efforts were associated with successful integration of quality and safety content into rounds, and increased implementation of QI interventions. Consistent effects on educational outcomes were difficult to identify, likely due to the use of methodologies ill-fitted for educational research. These results are encouraging for those seeking to optimise the quality and safety mission of M&M rounds. However, the inability to identify consistent educational effects suggests the investigation of M&M rounds could benefit from additional methodologies (qualitative, mixed methods) in order to understand the complex mechanisms driving learning at M&M rounds. © 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 expressly granted.

  2. Consumer acceptance of irradiated food: theory and reality

    NASA Astrophysics Data System (ADS)

    Bruhn, Christine M.

    1998-06-01

    For years most consumers have expressed less concern about food irradiation than other food processing technologies. Attitude studies have demonstrated that when given science-based information, from 60% to 90% of consumers prefer the advantages irradiation processing provides. When information is accompanied by samples, acceptance may increase to 99%. Information on irradiation should include product benefits, safety and wholesomeness, address environmental safety issues, and include endorsements by recognized health authorities. Educational and marketing programs should now be directed toward retailers and processors. Given the opportunity, consumers will buy high quality, safety-enhanced irradiated food.

  3. GPs' compliance with health and safety legislation and their occupational health needs in one London health authority.

    PubMed Central

    Kennedy, Ioanna; Williams, Siân; Reynolds, Anne; Cockcroft, Anne; Solomon, Jack; Farrow, Stephen

    2002-01-01

    This survey assessed general practitioners' (GPs') knowledge of and compliance with, health and safety legislation and occupational health guidance in one London health authority. The response rate was 85%. Although the majority of practices were aware of the most important piece of legislation--The Management of Health and Safety at Work Regulations, 1992--less than one in ten practices had carried out the required systematic risk assessments. Compliance with other health and safety legislation and related employment issues was also poor. The health of GPs and their staff may be at risk and these general practices may be vulnerable to prosecution by the Health and Safety Executive. PMID:12236278

  4. Minimizing treatment planning errors in proton therapy using failure mode and effects analysis

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Zheng, Yuanshui, E-mail: yuanshui.zheng@okc.procure.com; Johnson, Randall; Larson, Gary

    Purpose: Failure mode and effects analysis (FMEA) is a widely used tool to evaluate safety or reliability in conventional photon radiation therapy. However, reports about FMEA application in proton therapy are scarce. The purpose of this study is to apply FMEA in safety improvement of proton treatment planning at their center. Methods: The authors performed an FMEA analysis of their proton therapy treatment planning process using uniform scanning proton beams. The authors identified possible failure modes in various planning processes, including image fusion, contouring, beam arrangement, dose calculation, plan export, documents, billing, and so on. For each error, the authorsmore » estimated the frequency of occurrence, the likelihood of being undetected, and the severity of the error if it went undetected and calculated the risk priority number (RPN). The FMEA results were used to design their quality management program. In addition, the authors created a database to track the identified dosimetric errors. Periodically, the authors reevaluated the risk of errors by reviewing the internal error database and improved their quality assurance program as needed. Results: In total, the authors identified over 36 possible treatment planning related failure modes and estimated the associated occurrence, detectability, and severity to calculate the overall risk priority number. Based on the FMEA, the authors implemented various safety improvement procedures into their practice, such as education, peer review, and automatic check tools. The ongoing error tracking database provided realistic data on the frequency of occurrence with which to reevaluate the RPNs for various failure modes. Conclusions: The FMEA technique provides a systematic method for identifying and evaluating potential errors in proton treatment planning before they result in an error in patient dose delivery. The application of FMEA framework and the implementation of an ongoing error tracking system at their clinic have proven to be useful in error reduction in proton treatment planning, thus improving the effectiveness and safety of proton therapy.« less

  5. Laboratory Safety in the Biology Lab.

    ERIC Educational Resources Information Center

    Ritch, Donna; Rank, Jane

    2001-01-01

    Reports on a research project to determine if students possess and comprehend basic safety knowledge. Shows a significant increase in the amount of safety knowledge gained when students are exposed to various topics in laboratory safety and are held accountable for learning the information as required in a laboratory safety course. (Author/MM)

  6. Safety and health concerns in forestry operations

    Treesearch

    Robert B. Rummer

    1997-01-01

    The author discusses several safety models, including the "Three E?s": engineering, education, and enforcement; the Heinrich-Lateiner model; the organizational model; and the behavioral safety model. Rummer encourages approaching safety from a broader perspective, enabling the industry to track changes in all aspects and to keep leading the safety target....

  7. Commonwealth of Virginia, Department of Transportation Safety, transportation safety plan for the period July 1, 1981-June 30, 1982.

    DOT National Transportation Integrated Search

    1981-01-01

    Senate Bill 85, passed by the General Assembly in 1978, renamed the Highway Safety Division of Virginia the Department of Transportation Safety (VDTS) and authorized it to participate in the evaluation of current safety measures in all modes of trans...

  8. An epistemology of patient safety research: a framework for study design and interpretation. Part 1. Conceptualising and developing interventions.

    PubMed

    Brown, C; Hofer, T; Johal, A; Thomson, R; Nicholl, J; Franklin, B D; Lilford, R J

    2008-06-01

    This is the first of a four-part series of articles examining the epistemology of patient safety research. Parts 2 and 3 will describe different study designs and methods of measuring outcomes in the evaluation of patient safety interventions, before Part 4 suggests that "one size does not fit all". Part 1 sets the scene by defining patient safety research as a challenging form of service delivery and organisational research that has to deal (although not exclusively) with some very rare events. It then considers two inter-related ideas: a causal chain that can be used to identify where in an organisation's structure and/or processes an intervention may impact; and the need for preimplementation evaluation of proposed interventions. Finally, the paper outlines the authors' pragmatist ontological stance to patient safety research, which sets the philosophical basis for the remaining three articles.

  9. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... this part. The Food Safety Inspection Service and its officers and employees shall not be liable in...

  10. 49 CFR 365.507 - FMCSA action on the application.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS RULES... databases of the governments of Mexico and the United States. (c) Pre-authorization safety audit. Every...

  11. 49 CFR 365.507 - FMCSA action on the application.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS RULES... databases of the governments of Mexico and the United States. (c) Pre-authorization safety audit. Every...

  12. Safety Assessment of Pentaerythrityl Tetraesters as Used in Cosmetics.

    PubMed

    Becker, Lillian C; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

    2015-09-01

    The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) reviewed the safety of 16 pentaerythrityl tetraester compounds as used in cosmetics. These ingredients mostly function as hair-conditioning agents, skin-conditioning agents-miscellaneous and binders, skin-conditioning agents-occlusive, viscosity-increasing agents-nonaqueous, and skin-conditioning agents-emollient. The Panel reviewed the available animal and human data related to these ingredients and previous safety assessments of the fatty acid moieties. The Panel concluded that pentaerythrityl tetraisostearate and the other pentaerythrityl tetraester compounds were safe in the practices of use and concentration as given in this safety assessment. © The Author(s) 2015.

  13. Hazards in the hospital.

    PubMed

    Seibert, P J

    1994-02-01

    In an earlier article (JAVMA, Jan 15, 1994), the author outlined some of the first steps necessary in establishing a hospital safety program that will comply with current Occupational Safety and Health Administration (OSHA) guidelines. One of the main concerns of the OSHA guidelines is that there be written plans for managing hazardous materials, performing dangerous jobs, and dealing with other potential safety problems. In this article, the author discusses potentially hazardous situations commonly found in veterinary practices and provides details on how to minimize the risks associated with those situations and how to implement safety procedures that will comply with the OSHA guidelines.

  14. Safety philosophy of gas turbine high temperature reactor (GTHTR300)

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Shoji Katanishi; Kazuhiko Kunitomi; Shusaku Shiozawa

    2002-07-01

    Japan Atomic Energy Research Institute (JAERI) has undertaken the study of an original design concept of gas turbine high temperature reactor, the GTHTR300. The general concept of this study is development of a greatly simplified design that leads to substantially reduced technical and cost requirements. Newly proposed design features enable the GTHTR300 to be an efficient and economically competitive reactor in 2010's. Also, the GTHTR300 fully takes advantage of its inherent safety characteristics. The safety philosophy of the GTHTR300 is developed based on the HTTR (High Temperature Engineering Test Reactor) of JAERI which is the first HTGR in Japan. Majormore » features of the newly proposed safety philosophy for the GTHTR300 are described in this article. (authors)« less

  15. Addressing fear of crime in public space: gender differences in reaction to safety measures in train transit.

    PubMed

    Yavuz, Nilay; Welch, Eric W

    2010-01-01

    Research has identified several factors that affect fear of crime in public space. However, the extent to which gender moderates the effectiveness of fear-reducing measures has received little attention. Using data from the Chicago Transit Authority Customer Satisfaction Survey of 2003, this study aims to understand whether train transit security practices and service attributes affect men and women differently. Findings indicate that, while the presence of video cameras has a lower effect on women's feelings of safety compared with men, frequent and on-time service matters more to male passengers. Additionally, experience with safety-related problems affects women significantly more than men. Conclusions discuss the implications of the study for theory and gender-specific policies to improve perceptions of transit safety.

  16. Energy efficiency in urban management: Russian and world experience

    NASA Astrophysics Data System (ADS)

    Pryadko, Igor

    2017-10-01

    The article discusses the role of energetics in creating a comfortable and safe environment of modern megacities, and the problem is considered in the socio-economic aspect. The object is the energy security of the city, and the subject is the influence of urban society on the formation of energy security. In particular, the problems are raised: ecological problems of urban energy supply, the condition of surface layer of the atmosphere near electric power lines. The author assesses the actions, implemented by the urban authorities in Mytischi, in the southwestern areas of New Moscow. The author assesses these sample areas on the basis of Ch. Landry’s concept of self-training, designated for municipal authorities and urban communities, and offers several successfully implemented self-study cases and in the light of modern methods of ensuring energy security. The forecasts of creation of energy-safe space, made by modern sociologist-urbanist Leo Hollis, are taken into account. The author also considers some of the economic aspects of biosphere safety. In particular, he insists that biosphere safety, convenience, and comfort have developed into competitive advantages in the housing market.

  17. An integrated and pragmatic approach: Global plant safety management

    NASA Astrophysics Data System (ADS)

    McNutt, Jack; Gross, Andrew

    1989-05-01

    The Bhopal disaster in India in 1984 has compelled manufacturing companies to review their operations in order to minimize their risk exposure. Much study has been done on the subject of risk assessment and in refining safety reviews of plant operations. However, little work has been done to address the broader needs of decision makers in the multinational environment. The corporate headquarters of multinational organizations are concerned with identifying vulnerable areas to assure that appropriate risk-minimization measures are in force or will be taken. But the task of screening global business units for safety prowess is complicated and time consuming. This article takes a step towards simplifying this process by presenting the decisional model developed by the authors. Beginning with an overview of key issues affecting global safety management, the focus shifts to the multinational vulnerability model developed by the authors, which reflects an integration of approaches. The article concludes with a discussion of areas for further research. While the global chemical industry and major incidents therein are used for illustration, the procedures and solutions suggested here are applicable to all manufacturing operations.

  18. OSHA Laboratory Standard: Driving Force for Laboratory Safety!

    ERIC Educational Resources Information Center

    Roy, Kenneth R.

    2000-01-01

    Discusses the Occupational Safety and Health Administration's (OSHA's) Laboratory Safety Standards as the major driving force in establishing and maintaining a safe working environment for teachers and students. (Author)

  19. Impacts of Job Stress and Cognitive Failure on Patient Safety Incidents among Hospital Nurses.

    PubMed

    Park, Young-Mi; Kim, Souk Young

    2013-12-01

    This study aimed to identify the impacts of job stress and cognitive failure on patient safety incidents among hospital nurses in Korea. The study included 279 nurses who worked for at least 6 months in five general hospitals in Korea. Data were collected with self-administered questionnaires designed to measure job stress, cognitive failure, and patient safety incidents. This study showed that 27.9% of the participants had experienced patient safety incidents in the past 6 months. Factors affecting incidents were found to be shift work [odds ratio (OR) = 6.85], cognitive failure (OR = 2.92), lacking job autonomy (OR = 0.97), and job instability (OR = 1.02). Patient safety incidents were affected by shift work, cognitive failure, and job stress. Many countermeasures to reduce the incidents caused by shift work, and plans to reduce job stress to reduce the workers' cognitive failure are required. In addition, there is a necessity to reduce job instability and clearly define the scope and authority for duties that are directly related to the patient's safety.

  20. Impacts of Job Stress and Cognitive Failure on Patient Safety Incidents among Hospital Nurses

    PubMed Central

    Park, Young-Mi; Kim, Souk Young

    2013-01-01

    Background This study aimed to identify the impacts of job stress and cognitive failure on patient safety incidents among hospital nurses in Korea. Methods The study included 279 nurses who worked for at least 6 months in five general hospitals in Korea. Data were collected with self-administered questionnaires designed to measure job stress, cognitive failure, and patient safety incidents. Results This study showed that 27.9% of the participants had experienced patient safety incidents in the past 6 months. Factors affecting incidents were found to be shift work [odds ratio (OR) = 6.85], cognitive failure (OR = 2.92), lacking job autonomy (OR = 0.97), and job instability (OR = 1.02). Conclusion Patient safety incidents were affected by shift work, cognitive failure, and job stress. Many countermeasures to reduce the incidents caused by shift work, and plans to reduce job stress to reduce the workers' cognitive failure are required. In addition, there is a necessity to reduce job instability and clearly define the scope and authority for duties that are directly related to the patient's safety. PMID:24422177

  1. The association between patient safety culture and burnout and sense of coherence: A cross-sectional study in restructured and not restructured intensive care units.

    PubMed

    Vifladt, Anne; Simonsen, Bjoerg O; Lydersen, Stian; Farup, Per G

    2016-10-01

    To study the associations between registered nurses' (RNs) perception of the patient safety culture (safety culture) and burnout and sense of coherence, and to compare the burnout and sense of coherence in restructured and not restructured intensive care units (ICUs). Cross-sectional study. RNs employed at seven ICUs in six hospitals at a Norwegian Hospital Trust. One to four years before the study, three hospitals merged their general and medical ICUs into one general mixed ICU. The safety culture, burnout and sense of coherence were measured with the questionnaires Hospital Survey on Patient Safety Culture, Bergen Burnout Indicator and Sense of Coherence. Participant characteristics and working in restructured and not restructured ICUs were registered. In total, 143/289(49.5%) RNs participated. A positive safety culture was statistically significantly associated with a low score for burnout and a strong sense of coherence. No statistically significant differences were found in burnout and sense of coherence between RNs in the restructured and not restructured ICUs. In this study, a positive safety culture was associated with absence of burnout and high ability to cope with stressful situations. Burnout and sense of coherence were independent of the restructuring process. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  2. 77 FR 17504 - Agency Information Collection Activities: Proposed Collection; Comments Requested: Notification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-26

    ...: Notification to Fire Safety Authority of Storage of Explosive Materials. (3) Agency form number, if any, and... provided both orally and in writing to the authority having jurisdiction for fire safety in the locality in...] Agency Information Collection Activities: Proposed Collection; Comments Requested: Notification to Fire...

  3. 14 CFR Special Federal Aviation... - Robinson R-22/R-44 Special Training and Experience Requirements

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., may obtain an endorsement from an FAA aviation safety inspector in lieu of completing the awareness... authorized by endorsement from an FAA aviation safety inspector or authorized designated examiner that the... Experience Requirements Federal Special Federal Aviation Regulation No. 73 Aeronautics and Space FEDERAL...

  4. 33 CFR 96.490 - What further obligations exist for an organization if the Coast Guard terminates its authorization?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY VESSEL OPERATING REGULATIONS RULES FOR THE SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS Authorization of Recognized... companies and vessels must do to have their safety management systems transferred to another organization...

  5. 77 FR 64450 - Hazardous Materials: Incorporation of Certain Special Permits and Competent Authorities Into...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-22

    ... varies from the regulations provided an equivalent level of safety is maintained. An approval is a... materials regulations (HMR) provided an equivalent level of safety is maintained. A competent authority (CA... drums. Transportation of spent bleaching earth. Requalification of non-DOT specification cylinders in...

  6. Beyond safety outcomes: An investigation of the impact of safety climate on job satisfaction, employee engagement and turnover using social exchange theory as the theoretical framework.

    PubMed

    Huang, Yueng-Hsiang; Lee, Jin; McFadden, Anna C; Murphy, Lauren A; Robertson, Michelle M; Cheung, Janelle H; Zohar, Dov

    2016-07-01

    Safety climate, a measure of the degree to which safety is perceived by employees to be a priority in their company, is often implicated as a key factor in the promotion of injury-reducing behavior and safe work environments. Using social exchange theory as a theoretical basis, this study hypothesized that safety climate would be related to employees' job satisfaction, engagement, and turnover rate, highlighting the beneficial effects of safety climate beyond typical safety outcomes. Survey data were collected from 6207 truck drivers from two U.S. trucking companies. The objective turnover rate was collected one year after the survey data collection. Results showed that employees' safety climate perceptions were linked to employees' level of job satisfaction, engagement, and objective turnover rate, thus supporting the application of social exchange theory. Job satisfaction was also a significant mediator between safety climate and the two human resource outcomes (i.e., employee engagement and turnover rate). This study is among the first to assess the impact of safety climate beyond safety outcomes among lone workers (using truck drivers as an exemplar). Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  7. Adolescent Workers' Experiences of and Training for Workplace Violence.

    PubMed

    Smith, Carolyn R; Gillespie, Gordon L; Beery, Theresa A

    2015-07-01

    Adolescent workers may not be aware that violence is a safety concern in the workplace. As part of a larger mixed-methods pilot study, investigators used a self-administered survey and individual interviews with 30 adolescent workers from a chain of food service stores in a Midwestern metropolitan area to explore experiences of workplace violence (WPV) and ways of learning WPV-specific information. Participants reported experiencing verbal and sexual harassment and robberies. Most participants reported awareness of WPV-specific policies and procedures at their workplace; the ways participants reported learning WPV-specific information varied. Findings support the need for occupational safety training to assist adolescent workers prevent and mitigate potential WPV. © 2015 The Author(s).

  8. School Bus Fleet Safety: Planning and Development.

    ERIC Educational Resources Information Center

    Bieber, Robert M.

    1984-01-01

    To ensure worker safety, fleet safety managers need professional staffs, good access to top management, and sufficient authority to discharge their duties. Safety programs should include careful driver hiring; training, including orientation, testing, and practice; comprehensive accident reporting; and cooperative compliance programs with…

  9. The development of a methodology for transportation safety planning in Virginia.

    DOT National Transportation Integrated Search

    1980-01-01

    Senate Bill 85, passed by the General Assembly in 1978, renamed the former Highway Safety Division of Virginia the Department of Transportation Safety (VDTS) and authorized it to assume control over safety activities in all modes of transportation. T...

  10. Developing a smartphone based warning system application to enhance the safety at work zones : final report.

    DOT National Transportation Integrated Search

    2016-05-01

    Collisions in the work zone have always been a contributing factor to compromising safety on urban roadways. The National Highway Traffic Safety Administration (NHTSA) and the State Transportation Authorities have implemented many safety countermeasu...

  11. 75 FR 77675 - AREVA NP, Inc.; Confirmatory Order (Effective Immediately)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-13

    ..., appropriate notification of regulatory authorities, safety culture and safety conscious work environment...., outside the global AREVA organization), safety culture assessment in accordance with an accepted nuclear....e., outside the global AREVA organization), safety culture assessment in accordance with an accepted...

  12. [The role of safety climate and the relationship with job satisfaction: an exploratory study across three different occupational contexts.

    PubMed

    Emanuel, Federica; Colombo, Lara; Cortese, Claudio G; Ghislieri, Chiara

    2017-12-01

    This study examined the role of the "safety climate", or the organization's attention to health and safety of workers, and of job demand and resources in relation with job satisfaction. Wellbeing at work is a topic of growing interest, in line with the legislation and the programs on health and safety of workers and management and the evaluation of psychosocial risks. Several studies show that organizational actions concerning health and safety can be an indicator of the attention to employees' wellbeing, even if studies about the relationship between safety climate and some psychosocial outcomes are scant. The study analysed the relationship between job demand, job resources, safety climate and job satisfaction in three different occupational contexts (public authority, N = 224; social care organization, N = 115; pharmaceutical company, N = 127); workers were divided into groups based on the risk level appeared in the objective assessment of work-related stress, in order to identify differences. The self-report questionnaire gathered information about: job satisfaction, work efforts, supervisors' support, colleagues support, safety climate (α between .72 and .93). Data analysis provided: Cronbach α, analysis of variance, correlations, stepwise multiple regressions. The results showed that job satisfaction (R2 between .23 and .88) had a negative relationship with efforts and a positive relationship with job resources and safety climate. It emerges the importance of safety climate: to support and promote wellbeing at work, organizations could endorse training and information programs on health and safety for all workers and management, not only for professional groups with high-risk level. Future studies could explore the relation between safety climate and other outcomes, such as emotional exhaustion or objective indicators of organizational health (e.g. absenteeism, accidents, etc.). Copyright© by Aracne Editrice, Roma, Italy.

  13. 47 CFR 90.20 - Public Safety Pool.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 5 2014-10-01 2014-10-01 false Public Safety Pool. 90.20 Section 90.20 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Public Safety Radio Pool § 90.20 Public Safety Pool. (a) Eligibility. The following are eligible to hold authorizations in...

  14. 47 CFR 90.20 - Public Safety Pool.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 5 2013-10-01 2013-10-01 false Public Safety Pool. 90.20 Section 90.20 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Public Safety Radio Pool § 90.20 Public Safety Pool. (a) Eligibility. The following are eligible to hold authorizations in...

  15. 47 CFR 90.20 - Public Safety Pool.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Public Safety Pool. 90.20 Section 90.20 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Public Safety Radio Pool § 90.20 Public Safety Pool. (a) Eligibility. The following are eligible to hold authorizations in...

  16. Safety in the Chemical Laboratory: Developing Departmental Safety Procedures.

    ERIC Educational Resources Information Center

    Renfrew, Malcolm M., Ed.; Palladino, George F.

    1980-01-01

    Presents rationale and guidelines for development of Safety Standard Operating Procedures (Safety SOP) specific for local conditions. Includes an outline of a Safety SOP developed for a department primarily focused on undergraduate education with a wide variety of expertise from common laborer to PhD with 20 years experience. (Author/JN)

  17. 77 FR 21782 - International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-11

    ... electronic submission of individual case safety reports to regulatory authorities, automated data mining... Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum...

  18. Randomized controlled trials and real-world observational studies in evaluating cardiovascular safety of inhaled bronchodilator therapy in COPD.

    PubMed

    Kardos, Peter; Worsley, Sally; Singh, Dave; Román-Rodríguez, Miguel; Newby, David E; Müllerová, Hana

    2016-01-01

    Long-acting muscarinic antagonist (LAMA) or long-acting β2-agonist (LABA) bronchodilators and their combination are recommended for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Although the efficacy of LAMAs and LABAs has been well established through randomized controlled trials (RCTs), questions remain regarding their cardiovascular (CV) safety. Furthermore, while the safety of LAMA and LABA monotherapy has been extensively studied, data are lacking for LAMA/LABA combination therapy, and the majority of the studies that have reported on the CV safety of LAMA/LABA combination therapy were not specifically designed to assess this. Evaluation of CV safety for COPD treatments is important because many patients with COPD have underlying CV comorbidities. However, severe CV and other comorbidities are often exclusion criteria for RCTs, contributing to a lack in external validity and generalizability. Real-world observational studies are another important tool to evaluate the effectiveness and safety of COPD therapies in a broader population of patients and can improve upon the external validity limitations of RCTs. We examine what is already known regarding the CV and cerebrovascular safety of LAMA/LABA combination therapy from RCTs and real-world observational studies, and explore the advantages and limitations of data derived from each study type. We also describe an ongoing prospective, observational, comparative post-authorization safety study of a LAMA/LABA combination therapy (umeclidinium/vilanterol) and LAMA monotherapy (umeclidinium) versus tiotropium, with a focus on the relative merits of the study design.

  19. Evaluation of the organisation and effectiveness of internal audits to govern patient safety in hospitals: a mixed-methods study.

    PubMed

    van Gelderen, Saskia C; Zegers, Marieke; Boeijen, Wilma; Westert, Gert P; Robben, Paul B; Wollersheim, Hub C

    2017-07-10

    Hospital boards are legally responsible for safe healthcare. They need tools to assist them in their task of governing patient safety. Almost every Dutch hospital performs internal audits, but the effectiveness of these audits for hospital governance has never been evaluated. The aim of this study is to evaluate the organisation of internal audits and their effectiveness for hospitals boards to govern patient safety. A mixed-methods study consisting of a questionnaire regarding the organisation of internal audits among all Dutch hospitals (n=89) and interviews with stakeholders regarding the audit process and experienced effectiveness of audits within six hospitals. Response rate of the questionnaire was 76% and 43 interviews were held. In every responding hospital, the internal audits followed the plan-do-check-act cycle. Every hospital used interviews, document analysis and site visits as input for the internal audit. Boards stated that effective aspects of internal audits were their multidisciplinary scope, their structured and in-depth approach, the usability to monitor improvement activities and to change hospital policy and the fact that results were used in meetings with staff and boards of supervisors. The qualitative methods (interviews and site visits) used in internal audits enable the identification of soft signals such as unsafe culture or communication and collaboration problems. Reported disadvantages were the low frequency of internal audits and the absence of soft signals in the actual audit reports. This study shows that internal audits are regarded as effective for patient safety governance, as they help boards to identify patient safety problems, proactively steer patient safety and inform boards of supervisors on the status of patient safety. The description of the Dutch internal audits makes these audits replicable to other healthcare organisations in different settings, enabling hospital boards to complement their systems to govern patient safety. © 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.

  20. Mental models of safety: do managers and employees see eye to eye?

    PubMed

    Prussia, Gregory E; Brown, Karen A; Willis, P Geoff

    2003-01-01

    Disagreements between managers and employees about the causes of accidents and unsafe work behaviors can lead to serious workplace conflicts and distract organizations from the important work of establishing positive safety climate and reducing the incidence of accidents. In this study, the authors examine a model for predicting safe work behaviors and establish the model's consistency across managers and employees in a steel plant setting. Using the model previously described by Brown, Willis, and Prussia (2000), the authors found that when variables influencing safety are considered within a framework of safe work behaviors, managers and employees share a similar mental model. The study then contrasts employees' and managers' specific attributional perceptions. Findings from these more fine-grained analyses suggest the two groups differ in several respects about individual constructs. Most notable were contrasts in attributions based on their perceptions of safety climate. When perceived climate is poor, managers believe employees are responsible and employees believe managers are responsible for workplace safety. However, as perceived safety climate improves, managers and employees converge in their perceptions of who is responsible for safety. It can be concluded from this study that in a highly interdependent work environment, such as a steel mill, where high system reliability is essential and members possess substantial experience working together, managers and employees will share general mental models about the factors that contribute to unsafe behaviors, and, ultimately, to workplace accidents. It is possible that organizations not as tightly coupled as steel mills can use such organizations as benchmarks, seeking ways to create a shared understanding of factors that contribute to a safe work environment. Part of this improvement effort should focus on advancing organizational safety climate. As climate improves, managers and employees are likely to agree more about the causes of safe/unsafe behaviors and workplace accidents, ultimately increasing their ability to work in unison to prevent accidents and to respond appropriately when they do occur. Finally, the survey items included in this study may be useful to organizations wishing to conduct self-assessments.

  1. Examining the validity of AHRQ's patient safety indicators (PSIs): is variation in PSI composite score related to hospital organizational factors?

    PubMed

    Shin, Marlena H; Sullivan, Jennifer L; Rosen, Amy K; Solomon, Jeffrey L; Dunn, Edward J; Shimada, Stephanie L; Hayes, Jennifer; Rivard, Peter E

    2014-12-01

    Increasing use of Agency for Healthcare Research and Quality's Patient Safety Indicators (PSIs) for hospital performance measurement intensifies the need to critically assess their validity. Our study examined the extent to which variation in PSI composite score is related to differences in hospital organizational structures or processes (i.e., criterion validity). In site visits to three Veterans Health Administration hospitals with high and three with low PSI composite scores ("low performers" and "high performers," respectively), we interviewed a cross-section of hospital staff. We then coded interview transcripts for evidence in 13 safety-related domains and assessed variation across high and low performers. Evidence of leadership and coordination of work/communication (organizational process domains) was predominantly favorable for high performers only. Evidence in the other domains was either mixed, or there were insufficient data to rate the domains. While we found some evidence of criterion validity, the extent to which variation in PSI rates is related to differences in hospitals' organizational structures/processes needs further study. © The Author(s) 2014.

  2. An examination of the impact of five grade crossing safety factors on driver decision making

    DOT National Transportation Integrated Search

    2014-04-01

    The authors applied signal detection theory to model the impact : of five grade-crossing safety factors to understand their impact : on driver decision making. The safety factors were improving : commercial motor vehicle (CMV) driver safety through f...

  3. Training in quality and safety: the current landscape.

    PubMed

    Karasick, Andrew S; Nash, David B

    2015-01-01

    The current US health care environment requires and encourages the development and implementation of training programs focusing on quality improvement and patient safety. This article offers a new resource that details the basic characteristics of such physician-inclusive training programs. Specifically, program type, objectives, eligibility, cost, training length, and modality are aggregated and displayed to provide health care professionals with a new tool to facilitate individual education in the field of quality improvement and patient safety. © The Author(s) 2014.

  4. Safety Assessment of Microbial Polysaccharide Gums as Used in Cosmetics.

    PubMed

    Fiume, Monice M; Heldreth, Bart; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

    2016-07-01

    The Cosmetic Ingredient Review Expert Panel assessed the safety of 34 microbial polysaccharide gums for use in cosmetics, finding that these ingredients are safe in cosmetic formulations in the present practices of use and concentration. The microbial polysaccharide gums named in this report have a variety of reported functions in cosmetics, including emulsion stabilizer, film former, binder, viscosity-increasing agent, and skin-conditioning agent. The Panel reviewed available animal and clinical data in making its determination of safety. © The Author(s) 2016.

  5. Safety of clinical and non-clinical decision makers in telephone triage: a narrative review.

    PubMed

    Wheeler, Sheila Q; Greenberg, Mary E; Mahlmeister, Laura; Wolfe, Nicole

    2015-09-01

    Patient safety is a persistent problem in telephone triage research; however, studies have not differentiated between clinicians' and non-clinicians' respective safety. Currently, four groups of decision makers perform aspects of telephone triage: clinicians (physicians, nurses), and non-clinicians (emergency medical dispatchers (EMD) and clerical staff). Using studies published between 2002-2012, we applied Donabedian's structure-process-outcome model to examine groups' systems for evidence of system completeness (a minimum measure of structure and quality). We defined system completeness as the presence of a decision maker and four additional components: guidelines, documentation, training, and standards. Defining safety as appropriate referrals (AR) - (right time, right place with the right person), we measured each groups' corresponding AR rate percentages (outcomes). We analyzed each group's respective decision-making process as a safe match to the telephone triage task, based on each group's system structure completeness, process and AR rates (outcome). Studies uniformly noted system component presence: nurses (2-4), physicians (1), EMDs (2), clerical staff (1). Nurses had the highest average appropriate referral (AR) rates (91%), physicians' AR (82% average). Clerical staff had no system and did not perform telephone triage by standard definitions; EMDs may represent the use of the wrong system. Telephone triage appears least safe after hours when decision makers with the least complete systems (physicians, clerical staff) typically manage calls. At minimum, telephone triage decision makers should be clinicians; however, clinicians' safety calls for improvement. With improved training, standards and CDSS quality, the 24/7 clinical call center has potential to represent the national standard. © The Author(s) 2015.

  6. Monitoring injury in the New Zealand adventure tourism sector: an operator survey.

    PubMed

    Bentley, Tim A; Page, Stephen; Edwards, Joanna

    2008-01-01

    Client safety is a major risk management concern for the commercial adventure tourism sector in New Zealand. This study built on previous exploratory analyses of New Zealand adventure tourism safety, including industry surveys conducted by these authors in 1999 and 2003. The aims of the study were to provide a continuation of injury monitoring across the sector through data collected from self-reported injury incidence by industry operators and to compare findings with those from other primary and secondary research studies conducted by the authors. A postal questionnaire was used to survey all identifiable New Zealand adventure tourism operators during 2006. The questionnaire asked respondents about their recorded client injury experience, perceptions of client injury risk factors, and safety management practices. Some 21 adventure tourism activities were represented among the responding sample (n = 127), with most operations being very small in terms of staff numbers, although responding operators catered to nearly 1 million clients in total annually. Highest ranked risk factors for client injury included clients not following instructions; level of client skill, ability, and fitness; and changeable/unpredictable weather conditions. Highest client injury was reported for horse riding, ecotourism, and white water rafting sectors, although serious underreporting of minor injuries was evidenced across the sector. Slips, trips, and falls were the most frequently reported injury mechanism, while safety management measures were inconsistently applied across the sector. The industry should address reporting culture issues and safety management practices generally. Specifically, the industry should consider risk management that focuses on minor (eg, falls) as well as catastrophic events.

  7. Efficacy and safety of tofacitinib in patients with active rheumatoid arthritis: review of key Phase 2 studies.

    PubMed

    Fleischmann, Roy; Kremer, Joel; Tanaka, Yoshiya; Gruben, David; Kanik, Keith; Koncz, Tamas; Krishnaswami, Sriram; Wallenstein, Gene; Wilkinson, Bethanie; Zwillich, Samuel H; Keystone, Edward

    2016-12-01

    Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here, the safety and efficacy data from five Phase 2 studies of tofacitinib in patients with RA are summarized. Tofacitinib 1-30 mg twice daily was investigated, as monotherapy and in combination with methotrexate, in patients with RA. Tofacitinib 20 mg once daily was investigated in one study. Tofacitinib 5 and 10 mg twice daily were selected for investigation in Phase 3 studies; therefore, the efficacy and safety of tofacitinib 5 and 10 mg twice daily in Phase 2 studies are the focus of this review. Tofacitinib ≥ 5 mg twice daily was efficacious in a dose-dependent manner, with statistically significant and clinically meaningful reductions in the signs and symptoms of RA and patient-reported outcomes. The safety profile was consistent across studies. The efficacy and safety profile of tofacitinib in Phase 2 studies supported its further investigation and the selection of tofacitinib 5 mg twice daily and tofacitinib 10 mg twice daily for evaluation in Phase 3 studies. © 2016 The Authors. International Journal of Rheumatic Diseases published by Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.

  8. A safety assessment of biological therapies targeting the IL-23/IL-17 axis in inflammatory bowel diseases.

    PubMed

    Verstockt, Bram; Deleenheer, Barbara; Van Assche, Gert; Vermeire, Séverine; Ferrante, Marc

    2017-07-01

    Many different compounds targeting the interleukin 23/17 axis have been developed and successfully studied in several autoimmune diseases, including inflammatory bowel diseases. Nevertheless, interfering with key immunological pathways raises potential safety concerns. This review focuses on the safety profile of these novel biological therapies. Areas covered: A literature search until March 2017 was performed to collect safety data on different compounds targeting this pathway, with emphasis on ustekinumab and secukinumab. Firstly, the authors discuss briefly how genetics can inform about potential safety issues. Secondly, they extensively describe safety issues (common adverse events, infections, malignancies…), immunogenicity, exposure to ustekinumab in specific populations and provide advice for vaccination. Finally, they address safety profiles of secukinumab and other biological targeting the IL-23/17 axis in IBD. Expert opinion: Current evidence suggests that ustekinumab therapy overweigh the potential drug-related risks. Additional safety data beyond randomized-controlled trials, derived from statistically powered, large prospective studies with long-term follow-up are urgently needed to assess the real-life ustekinumab-related risks and to establish the correct position of these novel class of biologicals in IBD treatment. Combining immunomodulators with ustekinumab seems to be safe, though prospective data specifically addressing this topic are currently missing. Similarly, the combination of different biological therapies still has to be studied.

  9. Changes in patient safety culture after restructuring of intensive care units: Two cross-sectional studies.

    PubMed

    Vifladt, Anne; Simonsen, Bjoerg O; Lydersen, Stian; Farup, Per G

    2016-02-01

    Compare changes in registered nurses' perception of the patient safety culture in restructured and not restructured intensive care units during a four-year period. Two cross-sectional surveys were performed, in 2008/2009 (time 1) and 2012/2013 (time 2). During a period of 0-3 years after time 1, three of six hospitals merged their general and medical intensive care units (restructured). The other hospitals maintained their structure of the intensive care units (not restructured). Intensive care units in hospitals at one Norwegian hospital trust. The safety culture was measured with Hospital Survey on Patient Safety Culture. At times 1 and 2, 217/302 (72%) and 145/289 (50%) registered nurses participated. Restructuring was negatively associated with change in the safety culture, in particular, the dimensions of the safety culture within the unit level. The dimensions most vulnerable for restructuring were manager expectations and actions promoting safety, teamwork within hospital units and staffing. In this study, the restructuring of intensive care units was associated with a negative impact on the safety culture. When restructuring, the management should be particularly aware of changes in the safety culture dimensions manager expectations and actions promoting safety, teamwork within hospital units and staffing. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  10. State safety oversight program : audit of the tri-state oversight committee and the Washington metropolitan area transit authority, final audit report, March 4, 2010.

    DOT National Transportation Integrated Search

    2010-03-04

    The Federal Transit Administration (FTA) conducted an on-site audit of the safety program implemented by the Washington Metropolitan Area Transit Authority (WMATA) and overseen by the Tri-State Oversight Committee (TOC) between December 14 and 17, 20...

  11. Integration into Civil Airspace Airworthiness and Safety

    DTIC Science & Technology

    2003-09-02

    Integration into Civil Airspace Airworthiness and Safety 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER......into civil airspace lPurpose : n to explore and propose French process and means for integrating UAV into civil airspace. lMethod based on : n first

  12. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

  13. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

  14. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

  15. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

  16. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

  17. 49 CFR 1.95 - Delegations to the National Highway Traffic Safety Administrator.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...-related aspects of pedestrian and bicycle safety. (e) Carry out the functions and exercise the authority...) Carry out the functions and exercise the authority vested in the Secretary for the following provisions of Title 23, U.S.C. (with respect to matters within the primary responsibility of the National...

  18. Security Implications of Physical Design Attributes in the Emergency Department.

    PubMed

    Pati, Debajyoti; Pati, Sipra; Harvey, Thomas E

    2016-07-01

    Security, a subset of safety, is equally important in the efficient delivery of patient care. The emergency department (ED) is susceptible to violence creating concerns for the safety and security of patients, staff, and visitors and for the safe and efficient delivery of care. Although there is an implicit and growing recognition of the role of the physical environment, interventions typically have been at the microlevel. The objective of this study was to identify physical design attributes that potentially influence safety and efficiency of ED operations. An exploratory, qualitative research design was adopted to examine the efficiency and safety correlates of ED physical design attributes. The study comprised a multimeasure approach involving multidisciplinary gaming, semistructured interviews, and touring interviews of frontline staff in four EDs at three hospital systems across three states. Five macro physical design attributes (issues that need to be addressed at the design stage and expensive to rectify once built) emerged from the data as factors substantially associated with security issues. They are design issues pertaining to (a) the entry zone, (b) traffic management, (c) patient room clustering, (d) centralization versus decentralization, and (e) provisions for special populations. Data from this study suggest that ED security concerns are generally associated with three sources: (a) gang-related violence, (b) dissatisfied patients, and (c) behavioral health patients. Study data show that physical design has an important role in addressing the above-mentioned concerns. Implications for ED design are outlined in the article. © The Author(s) 2016.

  19. Anger and Pedagogy

    ERIC Educational Resources Information Center

    Mayo, Cris

    2016-01-01

    In his discussion of safety on campus, Eamonn Callan (2016) suggests a way to distinguish between two sorts of safety: "dignity safety" and "intellectual safety." As much as this author has some concerns that student activists should think more about pedagogy, she is not sure that "dignity" is the best approach to…

  20. 75 FR 59658 - Airworthiness Directives; SOCATA Model TBM 700 Airplanes

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-28

    ... drive assemblies. The European Aviation Safety Agency (EASA), which is the Technical Agent for the... United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section... Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. The Proposed...

  1. [Advance in studies on Aconitum traditional Chinese medicines in toxicokinetics and metabonomics].

    PubMed

    Ma, Tian-Yu; Yu, Teng-Fei; Li, Shu-Min; Li, Gang

    2014-06-01

    Aconitum, as a kind of common traditional Chinese medicine, contains multiple biological active substances, with a very high medicinal value but high toxicity. Its major toxic ingredients are aconitine, mesaconitine and hypaconitine, which are also efficient ingredients. Therefore, the safety of its clinical application has aroused wide attention. With the constant deepening of drug development studies, people want to learn about its toxic mechanism and the regularity of its emergence and development of its toxicology, so as to make a scientific and rational assessment for its safety. Therefore, toxicokinetics and metabonomics have gradually become important content in the new drug assessment. During the development of drug performance, it is crucial to establish a scientific, objective and standardized Aconitum safety evaluation system and correctly assess and utilize its toxicity. Having summarized studies on metabonomics and toxicokinetics of Aconitum drugs in recent years, authors proposed to strengthen the studies on Aconitum drug safety assessment and establish a scientific and standardized safety evaluation system as soon as possible, in order to make the national treasure more useful.

  2. Drug development and nonclinical to clinical translational databases: past and current efforts.

    PubMed

    Monticello, Thomas M

    2015-01-01

    The International Consortium for Innovation and Quality (IQ) in Pharmaceutical Development is a science-focused organization of pharmaceutical and biotechnology companies. The mission of the Preclinical Safety Leadership Group (DruSafe) of the IQ is to advance science-based standards for nonclinical development of pharmaceutical products and to promote high-quality and effective nonclinical safety testing that can enable human risk assessment. DruSafe is creating an industry-wide database to determine the accuracy with which the interpretation of nonclinical safety assessments in animal models correctly predicts human risk in the early clinical development of biopharmaceuticals. This initiative aligns with the 2011 Food and Drug Administration strategic plan to advance regulatory science and modernize toxicology to enhance product safety. Although similar in concept to the initial industry-wide concordance data set conducted by International Life Sciences Institute's Health and Environmental Sciences Institute (HESI/ILSI), the DruSafe database will proactively track concordance, include exposure data and large and small molecules, and will continue to expand with longer duration nonclinical and clinical study comparisons. The output from this work will help identify actual human and animal adverse event data to define both the reliability and the potential limitations of nonclinical data and testing paradigms in predicting human safety in phase 1 clinical trials. © 2014 by The Author(s).

  3. The Strategy for Safety: Preventing Crises through Safety Audits

    ERIC Educational Resources Information Center

    Schwartz, Sara Goldsmith

    2013-01-01

    In this article the author demonstrates the importance of school safety audits and describes what schools should focus on in a safety audit. Ultimately, each school should determine its own safety audit strategy based on its unique circumstances, including the type of community within which it is located, the age of the students it serves, and the…

  4. Monitoring safety in a phase III real‐world effectiveness trial: use of novel methodology in the Salford Lung Study

    PubMed Central

    Harvey, Catherine; Brewster, Jill; Bakerly, Nawar Diar; Elkhenini, Hanaa F.; Stanciu, Roxana; Williams, Claire; Brereton, Jacqui; New, John P.; McCrae, John; McCorkindale, Sheila; Leather, David

    2016-01-01

    Abstract Background The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once‐daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records. Objective The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in‐depth exploration of the safety results will be the subject of future publications. Achievements The SLS used a linked database system to capture relevant data from primary care practices in Salford and South Manchester, two university hospitals and other national databases. Patient data were collated and analysed to create daily summaries that were used to alert a specialist safety team to potential safety events. Clinical research teams at participating general practitioner sites and pharmacies also captured safety events during routine consultations. Confidence in the safety monitoring processes over time allowed the methodology to be refined and streamlined without compromising patient safety or the timely collection of data. The information technology infrastructure also allowed additional details of safety information to be collected. Conclusion Integration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. PMID:27804174

  5. The likelihood of achieving quantified road safety targets: a binary logistic regression model for possible factors.

    PubMed

    Sze, N N; Wong, S C; Lee, C Y

    2014-12-01

    In past several decades, many countries have set quantified road safety targets to motivate transport authorities to develop systematic road safety strategies and measures and facilitate the achievement of continuous road safety improvement. Studies have been conducted to evaluate the association between the setting of quantified road safety targets and road fatality reduction, in both the short and long run, by comparing road fatalities before and after the implementation of a quantified road safety target. However, not much work has been done to evaluate whether the quantified road safety targets are actually achieved. In this study, we used a binary logistic regression model to examine the factors - including vehicle ownership, fatality rate, and national income, in addition to level of ambition and duration of target - that contribute to a target's success. We analyzed 55 quantified road safety targets set by 29 countries from 1981 to 2009, and the results indicate that targets that are in progress and with lower level of ambitions had a higher likelihood of eventually being achieved. Moreover, possible interaction effects on the association between level of ambition and the likelihood of success are also revealed. Copyright © 2014 Elsevier Ltd. All rights reserved.

  6. Nuclear Safety Information Center, Its Products and Services

    ERIC Educational Resources Information Center

    Buchanan, J. R.

    1970-01-01

    The Nuclear Safety Information Center (NSIC) serves as a focal point for the collection, analysis and dissemination of information related to safety problems encountered in the design, analysis, and operation of nuclear facilities. (Author/AB)

  7. Alcohol/safety public information materials catalog. Number 5

    DOT National Transportation Integrated Search

    1981-06-01

    Author's abstract: The Alcohol/Safety Public Information Materials Catalog is designed for use by persons developing public information programs on alcohol and highway safety. It lists materials produced for campaigns along with journal articles and ...

  8. [Strategic patient safety action plan for the anesthesiology and intensive care service of Ukraine: basic modules and their components].

    PubMed

    Федосюк, Роман Н

    In recent years, the problem of patient safety has become top-priority in further improvement of national healthcare systems in all developed countries. To develop a modular structure and a component composition of the strategic patient safety action plan for the anesthesiology and intensive care service of Ukraine as a part of the National Action Plan. Major domestic priorities, substantiated and made public by the author in previous works, are taken as the basis for the modular structuring of the action plan. Existing foreign prototypes, evaluated for the patient safety effectiveness and the potential for the adaptation to domestic conditions, as well as author's own innovations are offered for a component filling-up of each module. Eight modules - infectious safety, surgical safety, pharmaceutical safety, infrastructural safety, incident monitoring and reporting, education and training, research and awards - have been proposed. Individual components for each of the modules are selected from a variety of foreign prototypes and author's own developments. Inter-modular stratification of the components into short-term perspective tools and long-term perspective tools, depending on the amount of resources needed for their implementation, is carried out. The strategic patient safety action plan for the anesthesiology and intensive care service of Ukraine is the embodiment, within a particular specialty, of the wider National Action Plan developed by the First National Congress on Patient Safety (Kiev, 2012) on the initiative of the Council of Europe and aimed at the fulfillment of international obligations of Ukraine in the healthcare sector. Its implementation will contribute to enhancing the safety of anesthesia and intensive care services in Ukraine and further development of the specialty.

  9. Unstoppable The Gap Between Public Safety and Traffic Safety in the Age of Driverless Cars

    DTIC Science & Technology

    2017-03-01

    themselves, what will the increase in traffic safety cost society in terms of public safety? • What can public safety and homeland security...industry. Safer products are more marketable products, and companies that work with law enforcement for the benefit of public safety may have an...secondary public safety benefit of crime suppression. Reasonable suspicion to stop a vehicle would be an infrequent occurrence, and the legal authority

  10. Beyond the classroom: a case study of immigrant safety liaisons in residential construction.

    PubMed

    Ochsner, Michele; Marshall, Elizabeth G; Martino, Carmen; Pabelón, Marién Casillas; Kimmel, Louis; Rostran, Damaris

    2012-01-01

    Latino day laborers often work at dangerous construction sites with little power to change conditions. We describe the development, implementation, and early-stage results of a program to train immigrant day laborers as safety liaisons. These are construction workers prepared to recognize and respond to health and safety hazards. Based in Newark, NJ, the project involves collaboration between New Labor, a membership-based worker center, and university researchers and labor educators. Safety liaisons undergo training and receive ongoing support for their roles. Both qualitative and quantitative data are collected to monitor progress. Although lacking in formal authority, safety liaisons have prompted improvements at specific sites, filed OSHA complaints, and developed a local worker council. Participatory training methods, opportunities for leadership outside the classroom, and participation in project planning have strengthened liaisons' effectiveness, leadership skills, and commitment. The safety liaison approach could be adapted by worker centers and their partner organizations.

  11. 31 CFR 538.519 - Aircraft and maritime safety.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Aircraft and maritime safety. 538.519..., Authorizations, and Statements of Licensing Policy § 538.519 Aircraft and maritime safety. Specific licenses may... aircraft, and to ensure the safety of ocean-going maritime traffic in international waters. ...

  12. 31 CFR 560.528 - Aircraft safety.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false Aircraft safety. 560.528 Section 560..., Authorizations and Statements of Licensing Policy § 560.528 Aircraft safety. Specific licenses may be issued on a... the safety of civil aviation and safe operation of U.S.-origin commercial passenger aircraft. ...

  13. 14 CFR 431.33 - Safety organization.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Safety organization. 431.33 Section 431.33... Launch and Reentry of a Reusable Launch Vehicle § 431.33 Safety organization. (a) An applicant shall maintain a safety organization and document it by identifying lines of communication and approval authority...

  14. 9 CFR 149.1 - Definitions.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... the feed mill to the pork production site. Food Safety and Inspection Service (FSIS). The Food Safety... Administrator, Food Safety and Inspection Service, or any person authorized to act for the Administrator. FSIS program employee. Any individual employed by or acting as an agent on behalf of the Food Safety and...

  15. 9 CFR 149.1 - Definitions.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... the feed mill to the pork production site. Food Safety and Inspection Service (FSIS). The Food Safety... Administrator, Food Safety and Inspection Service, or any person authorized to act for the Administrator. FSIS program employee. Any individual employed by or acting as an agent on behalf of the Food Safety and...

  16. 9 CFR 149.1 - Definitions.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... the feed mill to the pork production site. Food Safety and Inspection Service (FSIS). The Food Safety... Administrator, Food Safety and Inspection Service, or any person authorized to act for the Administrator. FSIS program employee. Any individual employed by or acting as an agent on behalf of the Food Safety and...

  17. 46 CFR 115.910 - Passenger Ship Safety Certificate.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 4 2011-10-01 2011-10-01 false Passenger Ship Safety Certificate. 115.910 Section 115... Ship Safety Certificate. (a) A vessel that carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate. The Commandant authorizes the cognizant...

  18. 46 CFR 115.910 - Passenger Ship Safety Certificate.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 4 2014-10-01 2014-10-01 false Passenger Ship Safety Certificate. 115.910 Section 115... Ship Safety Certificate. (a) A vessel that carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate. The Commandant authorizes the cognizant...

  19. 46 CFR 115.910 - Passenger Ship Safety Certificate.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 4 2012-10-01 2012-10-01 false Passenger Ship Safety Certificate. 115.910 Section 115... Ship Safety Certificate. (a) A vessel that carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate. The Commandant authorizes the cognizant...

  20. 46 CFR 115.910 - Passenger Ship Safety Certificate.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 4 2013-10-01 2013-10-01 false Passenger Ship Safety Certificate. 115.910 Section 115... Ship Safety Certificate. (a) A vessel that carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate. The Commandant authorizes the cognizant...

  1. 31 CFR 560.528 - Aircraft safety.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Aircraft safety. 560.528 Section 560..., Authorizations and Statements of Licensing Policy § 560.528 Aircraft safety. Specific licenses may be issued on a... the safety of civil aviation and safe operation of U.S.-origin commercial passenger aircraft. ...

  2. A Study to Estimate the Effectiveness of Visual Testing Training for Aviation Maintenance Management

    NASA Technical Reports Server (NTRS)

    Law, Lewis Lyle

    2007-01-01

    The Air Commerce Act of 1926 set the beginning for standards in aviation maintenance. Even after deregulation in the late l970s, maintenance standards and requirements still have not changed far from their initial criteria. After a potential candidate completes Federal Aviation Administration training prerequisites, they may test for their Airframe and Powerplant (A&P) certificate. Performing maintenance in the aviation industry for a minimum of three years, the technician may then test for their Inspection Authorization (IA). After receiving their Airframe and Powerplant certificate, a technician is said to have a license to perform. At no time within the three years to eligibility for Inspection Authorization are they required to attend higher-level inspection training. What a technician learns in the aviation maintenance industry is handed down from a seasoned technician to the new hire or is developed from lessons learned on the job. Only in Europe has the Joint Aviation Authorities (JAA) required higher-level training for their aviation maintenance technicians in order to control maintenance related accidents (Lu, 2005). Throughout the 1990s both the General Accounting Office (GAO) and the National Transportation Safety Board (NTSB) made public that the FAA is historically understaffed (GAO, 1996). In a safety recommendation the NTSB stated "The Safety Board continues to lack confidence in the FAA's commitment to provide effective quality assurance and safety oversight of the ATC system (NTSB, 1990)." The Federal Aviation Administration (FAA) has been known to be proactive in creating safer skies. With such reports you would suspect the FAA to also be proactive in developing more stringent inspection training for aviation maintenance technicians. The purpose of this study is to estimate the effectiveness of higher-level inspection training, such as Visual Testing (VT) for aviation maintenance technicians, to improve the safety of aircraft and to make recommendations to management with regard to the value of such training.

  3. RN assessments of excellent quality of care and patient safety are associated with significantly lower odds of 30-day inpatient mortality: A national cross-sectional study of acute-care hospitals.

    PubMed

    Smeds-Alenius, Lisa; Tishelman, Carol; Lindqvist, Rikard; Runesdotter, Sara; McHugh, Matthew D

    2016-09-01

    Quality and safety in health care has been increasingly in focus during the past 10-15 years. Stakeholders actively discuss ways to measure safety and quality of care to improve the health care system as a whole. Defining and measuring quality and safety, however, is complicated. One underutilized resource worthy of further exploration is the use of registered nurses (RNs) as informants of overall quality of care and patient safety. However, research is still scarce or lacking regarding RN assessments of patient safety and quality of care and their relationship to objective patient outcomes. To investigate relationships between RN assessed quality of care and patient safety and 30-day inpatient mortality post-surgery in acute-care hospitals. This is a national cross-sectional study. A survey (n=>10,000 RNs); hospital organizational data (n=67); hospital discharge registry data (n>200,000 surgical patients). RN data derives from a national sample of RNs working directly with inpatient care in surgical/medical wards in acute-care hospitals in Sweden in 2010. Patient data are from the same hospitals in 2009-2010. Adjusted multivariate logistic regression models were used to estimate relationships between RN assessments and 30-day inpatient mortality. Patients cared for in hospitals where a high proportion of RNs reported excellent quality of care (the highest third of hospitals) had 23% lower odds of 30-day inpatient mortality compared to patients cared for in hospitals in the lowest third (OR 0.77, CI 0.65-0.91). Similarly, patients in hospitals where a high proportion of RNs reported excellent patient safety (highest third) had is 26% lower odds of death (OR 0.74, CI 0.60-0.91). RN assessed excellent patient safety and quality of care are related to significant reductions in odds of 30-day inpatient mortality, suggesting that positive RN reports of quality and safety can be valid indicators of these key variables. Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

  4. Study on Communication System of Social Risk Information on Nuclear Energy

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Hidekazu Yoshikawa; Toshio Sugiman; Yasunaga Wakabayashi

    2004-07-01

    As a new risk communication method for the construction of effective knowledge bases about 'safety and non-anxiety for nuclear energy', a study on new communication method of social risk information by means of electronic communication has been started, by noticing rapid expansion of internet usage in the society. The purpose of this research is to enhance the public acceptance to nuclear power in Japan by the following two aspects. The first is to develop the mutual communication system among the working persons involved in both the operation and maintenance activities for nuclear power plant, by which they will exchange theirmore » daily experiences to improve the safety conscious activities to foster 'safety culture' attitude. The other is the development of an effective risk communication system between nuclear society and the general publics about the hot issues of 'what are the concerned involved in the final disposal of high-level radioactive waste?' and 'what should we do to have social consensus to deal with this issue in future'. The authors' research plan for the above purpose is summarized as shown in Table 1. As the first step of the authors' three year research project which started from August 2003, social investigation by questionnaires by internet and postal mail, have been just recently conducted on their risk perception for the nuclear power for the people engaged in nuclear business and women in the metropolitan area, respectively, in order to obtain the relevant information on how and what should be considered for constructing effective risk communication methods of social risk information between the people within nuclear industries and the general public in society. Although there need to be discussed, the contrasting risk images as shown in Fig.1, can be depicted between the nuclear people and general public these days in Japan, from the results of the social investigation. As the conclusion of the authors' study thus far conducted, the contrasting risk perceptions by both the nuclear people and the general public which are shown in Fig. 1, will contribute to the authors' development of two risk communication systems as the next step of this research project, the one for 'Community network system to foster safety culture among nuclear workers', while the other for 'Affective risk communication network open to society'. (authors)« less

  5. Why is patient safety so hard? A selective review of ethnographic studies.

    PubMed

    Dixon-Woods, Mary

    2010-01-01

    Ethnographic studies are valuable in studying patient safety. This is a narrative review of four reports of ethnographic studies of patient safety in UK hospitals conducted as part of the Patient Safety Research Programme. Three of these studies were undertaken in operating theatres and one in an A&E Department. The studies found that hospitals were rarely geared towards ensuring perfect performances. The coordination and mobilization of the large number of inter-dependent processes and resources needed to support the achievement of tasks was rarely optimal. This produced significant strain that staff learned to tolerate by developing various compensatory strategies. Teamwork and inter-professional communication did not always function sufficiently well to ensure that basic procedural information was shared or that the required sequence of events was planned. Staff did not always do the right things, for a wide range of different reasons, including contestations about what counted as the right thing. Structures of authority and accountability were not always clear or well-functioning. Patient safety incidents were usually not reported, though there were many different reasons for this. It can be concluded that securing patient safety is hard. There are multiple interacting influences on safety, and solutions need to be based on a sound understanding of the nature of the problems and which approaches are likely to be best suited to resolving them. Some solutions that appear attractive and straightforward are likely to founder. Addressing safety problems requires acknowledgement that patient safety is not simply a technical issue, but a site of organizational and professional politics.

  6. 29 CFR 1908.1 - Purpose and scope.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Agreements between states and the Federal Occupational Safety and Health Administration (OSHA) under sections... Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR...), the Occupational Safety and Health Administration Compliance Assistance Authorization Act of 1998...

  7. 29 CFR 1908.1 - Purpose and scope.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Agreements between states and the Federal Occupational Safety and Health Administration (OSHA) under sections... Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR...), the Occupational Safety and Health Administration Compliance Assistance Authorization Act of 1998...

  8. Worker Health and Safety: An Area of Conflicts

    ERIC Educational Resources Information Center

    Ashford, Nicholas A.

    1975-01-01

    The article outlines four basic conflicts concerning occupational health and safety, discusses the nature and dimensions of health and safety problems, examines the generation of information and its diffusion, and deals briefly with some economic issues. (Author)

  9. The Impact of Language and Culture Diversity in Occupational Safety.

    PubMed

    De Jesus-Rivas, Mayra; Conlon, Helen Acree; Burns, Candace

    2016-01-01

    Occupational health nursing plays a critical part in improving the safety of foreign labor workers. The development and implementation of safety training programs do not always regularly take into account language barriers, low literacy levels, or cultural elements. This oversight can lead to more injuries and fatalities among this group. Despite established health and safety training programs, a significant number of non-native English speakers are injured or killed in preventable, occupation-related accidents. Introducing safety programs that use alternative teaching strategies such as pictograms, illustrations, and hands-on training opportunities will assist in addressing challenges for non-English laborers. Occupational health nursing has an opportunity to provide guidance on this subject and assist businesses in creating a safer and more productive work environment. © 2015 The Author(s).

  10. The Creation of a French Basic Nuclear Installation - Description of the Regulatory Process - 13293

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Mahe, Carole; Leroy, Christine

    CEA is a French government-funded technological research organization. It has to build a medium-level waste interim storage facility because the geological repository will not be available until 2025. This interim storage facility, called DIADEM, has to be available in 2017. These wastes are coming from the research facilities for spent fuel reprocessing and the dismantling of the most radioactive parts of nuclear facilities. The CEA handles the waste management by inventorying the needs and updating them regularly. The conception of the facility is mainly based on this inventory. It provides quantity and characteristics of wastes and it gives the productionmore » schedule until 2035. Beyond mass and volume, main characteristics of these radioactive wastes are chemical nature, radioisotopes, radioactivity, radiation dose, the heat emitted, corrosive or explosive gas production, etc. These characteristics provide information to study the repository safety. DIADEM mainly consists of a concrete cell, isolated from the outside, wherein stainless steel welded containers are stored, stacked in a vertical position in the racks. DIADEM is scheduled to store three types of 8 mm-thick, stainless steel cylindrical containers with an outside diameter 498 mm and height from 620 to 2120 mm. DIADEM will be a basic nuclear installation (INB in French) because of overall activity of radioactive substances stored. The creation of a French basic nuclear installation is subject to authorization according to the French law No. 2006-686 of 13 June 2006 on Transparency and Security in the Nuclear Field. The authorization takes into account the technical and financial capacities of the licensee which must allow him to conduct his project in compliance with these interests, especially to cover the costs of decommissioning the installation and conduct remediation work, and to monitor and maintain its location site or, for radioactive waste disposal installations, to cover the definitive shut-down, maintenance and surveillance expenditure. The authorization is issued by a decree adopted upon advice of the French Nuclear Safety Authority and after a public enquiry. In accordance with Decree No. 2007-1557 of November 2, 2007, the application is filed with the ministries responsible for nuclear safety and the Nuclear Safety Authority. It consists of twelve files and four records information. The favorable opinion of the Nuclear Safety Authority on the folder is required to start the public inquiry. Once the public inquiry is completed, the building permit is issued by the prefect. (authors)« less

  11. The effects of organizational commitment and structural empowerment on patient safety culture.

    PubMed

    Horwitz, Sujin K; Horwitz, Irwin B

    2017-03-20

    Purpose The purpose of this paper is to investigate the relationship between patient safety culture and two attitudinal constructs: affective organizational commitment and structural empowerment. In doing so, the main and interaction effects of the two constructs on the perception of patient safety culture were assessed using a cohort of physicians. Design/methodology/approach Affective commitment was measured with the Organizational Commitment Questionnaire, whereas structural empowerment was assessed with the Conditions of Work Effectiveness Questionnaire-II. The abbreviated versions of these surveys were administered to a cohort of 71 post-doctoral medical residents. For the data analysis, hierarchical regression analyses were performed for the main and interaction effects of affective commitment and structural empowerment on the perception of patient safety culture. Findings A total of 63 surveys were analyzed. The results revealed that both affective commitment and structural empowerment were positively related to patient safety culture. A potential interaction effect of the two attitudinal constructs on patient safety culture was tested but no such effect was detected. Research limitations/implications This study suggests that there are potential benefits of promoting affective commitment and structural empowerment for patient safety culture in health care organizations. By identifying the positive associations between the two constructs and patient safety culture, this study provides additional empirical support for Kanter's theoretical tenet that structural and organizational support together helps to shape the perceptions of patient safety culture. Originality/value Despite the wide recognition of employee empowerment and commitment in organizational research, there has still been a paucity of empirical studies specifically assessing their effects on patient safety culture in health care organizations. To the authors' knowledge, this study is the first empirical study to examine the relationship between structural empowerment as proposed by Kanter and the culture of patient safety using physicians.

  12. 47 CFR 74.25 - Temporary conditional operating authority.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Aviation Administration and determined to pose no hazard to aviation safety as required by subpart B of... has not been previously studied by the Federal Aviation Administration and cleared by the FCC; (3) The...

  13. Regulation of Health Policy: Patient Safety and the States

    DTIC Science & Technology

    2005-05-01

    the consumer perspective about patient safety. Advances in Patient Safety: Vol 1 420 Note See e.g., Public Citizen, Inc. v. U.S. Dept. of Health ...405 Regulation of Health Policy: Patient Safety and the States Joanna Weinberg, Lee H. Hilborne, Quang-Tuyen Nguyen Abstract In its 1999...regulating patient safety. The authors suggest that State patient safety regulation illustrates ongoing tensions in U.S. health policy, and conclude that

  14. Convoy Active Safety Technology - Environmental Understanding and Navigation With Use of Low Cost Sensors

    DTIC Science & Technology

    2012-08-01

    ACTIVE SAFETY TECHNOLOGY – ENVIRONMENTAL UNDERSTANDING AND NAVIGATION WITH USE OF LOW COST SENSORS David Simon Lockheed Martin MFC, Grand Prairie, TX...Understanding and Navigation with use of low cost sensors 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) David Simon ; Bernard

  15. 75 FR 3946 - Tennessee Valley Authority; Establishment of Atomic Safety and Licensing Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-25

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-438-CP, 50-439-CP; ASLBP No. 10-896-01-CP-BD01] Tennessee Valley Authority; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by the Commission dated December 29, 1972, published in the Federal Register, 37 FR 28,710 (1972), and the...

  16. 76 FR 38457 - Reports, Forms and Record Keeping Requirements Agency Information Collection Activity Under OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-30

    ..., and 30117 of the National Traffic and Motor Vehicle Safety Act of 1996, authorizes the issuance of Federal Motor Vehicle Safety Standards (FMVSS). The Secretary is authorized to issue, amend, and revoke... designed to be carried mandatory in buses and trucks that have a gross vehicle weight rating (GVWR) greater...

  17. Assessing Explosives Safety Risks, Deviations, And Consequences

    DTIC Science & Technology

    2009-07-31

    Technical Paper 23 31 July 2009 DDESB Assessing Explosives Safety Risks, Deviations, And Consequences ...Deviations, And Consequences 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK NUMBER...and approaches to assist warfighters in executing their mission, conserving resources, and maximizing operational effectiveness . When mission risk

  18. Vessel traffic safety in busy waterways: A case study of accidents in western shenzhen port.

    PubMed

    Mou, J M; Chen, P F; He, Y X; Yip, Tsz Leung; Li, W H; Tang, J; Zhang, H Z

    2016-08-03

    Throughout the world, busy waterways near large ports witness heavy vessel traffic in recent decades. The waterways are characterized by high risk in terms of loss of life, property, and pollution to environment. To facilitate maritime safety management with satisfactory efficiency and efficacy, the authors propose a framework of safety indexes to evaluate the risk level in busy waterways according to the accident severity, fatality rate and special indicators of maritime transportation. The safety indexes consist of Safety Evaluation Index (SEI) and Safety Warning Index (SWI), and are derived from the proposed risk criteria of Chinese vessel traffic. As a case study, data on vessel traffic accidents reported in the Western Shenzhen Port, South China from 1995 to 2015 are analyzed. The actual risk level of this area during the period is calculated under the framework. The implementation of the safety indexes indicate that the risk criteria and safety indexes are practicable and effective for the vessel traffic management. The methodology based on long-term accident data can significantly support the risk analysis in the macroscopic perspective for busy ports and waterways, such that SWI can act as threshold to trigger actions, while SEI can act as an indicator to measure safety status. Copyright © 2016 Elsevier Ltd. All rights reserved.

  19. The Introduction of "Safety Science" into an Undergraduate Nursing Programme at a Large University in the United Kingdom.

    PubMed

    White, Nick; Clark, Deborah; Lewis, Robin; Robson, Wayne

    2016-04-13

    Implementing safety science {a term adopted by the authors which incorporates both patient safety and human factors (Sherwood, G. (2011). Integrating quality and safety science in nursing education and practice. Journal of Research in Nursing, 16(3), 226-240. doi: 10.1177/1744987111400960)} into healthcare programmes is a major challenge facing healthcare educators worldwide (National Advisory Group on the Safety of Patients in England, 2013; World Health Organisation, 2009). Patient safety concerns relating to human factors have been well-documented over the years, and the root cause(s) of as many as 65-80 % of these events are linked to human error (Dunn et al., 2007; Reason, 2005). This paper will describe how safety science education was embedded into a pre-registration nursing programme at a large UK university. The authors argue that the processes described in this paper, may be successfully applied to other pre-registration healthcare programmes in addition to nursing.

  20. Does Health Literacy Level Influence the Effectiveness of a Kiosk-Based Intervention Delivered in the Pediatric Emergency Department?

    PubMed

    Shields, Wendy C; McDonald, Eileen M; McKenzie, Lara B; Gielen, Andrea C

    2016-01-01

    This study assesses parents' literacy skills and evaluates how literacy levels influenced the effectiveness of a health communication intervention designed to improve safety knowledge in low-income, urban families. A total of n = 450 parents of children aged 4 to 66 months completed the Rapid Estimate of Adult Literacy in Medicine (REALM) and participated in a randomized trial of an injury prevention intervention delivered via computer kiosk in a pediatric emergency department. A safety knowledge test was administered by telephone 2 to 4 weeks later. More than one-third of parents were assessed by the REALM to have marginal (30%) or inadequate (8%) reading levels; the remaining 62% of parents had adequate reading levels. REALM scores were independently associated with knowledge gains for poison storage and smoke alarms. Participants reading level had an independent and significant effect on safety knowledge outcomes. Literacy level should be considered in all patient education efforts. © The Author(s) 2015.

  1. Experimenting the hospital survey on patient safety culture in prevention facilities in Italy: psychometric properties.

    PubMed

    Tereanu, Carmen; Smith, Scott A; Sampietro, Giuseppe; Sarnataro, Francesco; Mazzoleni, Giuliana; Pesenti, Bruno; Sala, Luca C; Cecchetti, Roberto; Arvati, Massimo; Brioschi, Dania; Viscardi, Michela; Prati, Chiara; Barbaglio, Giorgio G

    2017-04-01

    The Agency for Healthcare Research and Quality Hospital Survey on Patient Safety Culture (HSOPS) was designed to assess staff views on patient safety culture in hospital. This study examines psychometrics of the Italian translation of the HSOPS for use in territorial prevention facilities. After minimal adjustments and pre-test of the Italian version, a qualitative cross-sectional study was carried out. Departments of Prevention (DPs) of four Local Health Authorities in Northern Italy. Census of medical and non-medical staff (n. 479). Web-based self-administered questionnaire. Descriptive statistics, internal reliability, Confirmatory Factor Analysis (CFA) and intercorrelations among survey composites. Initial CFA of the 12 patient safety culture composites and 42 items included in the original version of the questionnaire revealed that two dimensions (Staffing and Overall Perception of Patient Safety) and nine individual items did not perform well among Italian territorial Prevention staff. After dropping those composites and items, psychometric properties were acceptable (comparative fit index = 0.94; root mean square error of approximation = 0.04; standardized root mean square residual = 0.04). Internal consistency for each remaining composite met or exceeded the criterion 0.70. Intercorrelations were all statistically significant. Psychometric analyses provided overall support for 10 of the 12 initial patient safety culture composites and 33 of the 42 initial composite items. Although the original instrument was intended for US Hospitals, the Italian translation of the HSOPS adapted for use in territorial prevention facilities performed adequately in Italian DPs. © The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  2. 10 CFR 35.14 - Notifications.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... licensee permits the individual to work as an authorized user, an authorized nuclear pharmacist, or an... nuclear pharmacist, a Radiation Safety Officer, or an authorized medical physicist permanently...

  3. 10 CFR 35.14 - Notifications.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... licensee permits the individual to work as an authorized user, an authorized nuclear pharmacist, or an... nuclear pharmacist, a Radiation Safety Officer, or an authorized medical physicist permanently...

  4. 10 CFR 35.14 - Notifications.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... licensee permits the individual to work as an authorized user, an authorized nuclear pharmacist, or an... nuclear pharmacist, a Radiation Safety Officer, or an authorized medical physicist permanently...

  5. 10 CFR 35.14 - Notifications.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... licensee permits the individual to work as an authorized user, an authorized nuclear pharmacist, or an... nuclear pharmacist, a Radiation Safety Officer, or an authorized medical physicist permanently...

  6. 10 CFR 35.14 - Notifications.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... licensee permits the individual to work as an authorized user, an authorized nuclear pharmacist, or an... nuclear pharmacist, a Radiation Safety Officer, or an authorized medical physicist permanently...

  7. Ingestion of safety razor blade and delayed hanging in a complex suicide.

    PubMed

    Chauhan, Mohit Singh; Behera, C; Naagar, Sunil; Sreenivas, M

    2016-12-01

    Ingestion of a foreign body is mostly accidental in children and intentional in prisoners to achieve hospitalization; however, use of this method of suicide is rare. We report a case where the victim first ingested a safety razor blade, but failed to die and then hanged himself, but failed again and finally succumbed to the complications on the sixth day. He had also attempted suicide by inflicting multiple incised wounds on his neck four days before the safety blade ingestion, but none were fatal. © The Author(s) 2016.

  8. Safety climate as a mediator between foundation climates and occupational accidents: a group-level investigation.

    PubMed

    Wallace, J Craig; Popp, Eric; Mondore, Scott

    2006-05-01

    Building on recent work in occupational safety and climate, the authors examined 2 organizational foundation climates thought to be antecedents of specific safety climate and the relationships among these climates and occupational accidents. It is believed that both foundation climates (i.e., management-employee relations and organizational support) will predict safety climate, which will in turn mediate the relationship between occupational accidents and these 2 distal foundation climates. Using a sample of 9,429 transportation workers in 253 work groups, the authors tested the proposed relationships at the group level. Results supported all hypotheses. Overall it appears that different climates have direct and indirect effects on occupational accidents.

  9. Guaranteed Ride Home: Taking the Worry Out of Ridesharing

    DOT National Transportation Integrated Search

    1986-07-01

    The Highway Safety Acts of 1973 and 1976 and the Surface Transportation Acts of 1978 and 1982 provide funding authorizations for individual states to improve safety at public rail-highway crossings. Safety improvements frequently consist of the insta...

  10. The Assessment of Motivation within Maslow's Framework.

    ERIC Educational Resources Information Center

    Haymes, Michael; Green, Logan

    1982-01-01

    Reports progress in the development of the Needsort, a research tool, for the assessment of the three developmentally earliest, within Maslow's framework, conative needs (physiological, safety, belongingness). Discusses item analyses, item selection methods, reliability studies, and validation studies across a broad range of populations. (Author)

  11. Perceived safety management practices in the logistics sector.

    PubMed

    Auyong, Hui-Nee; Zailani, Suhaiza; Surienty, Lilis

    2016-03-09

    Malaysia's progress on logistics has been slowed to keep pace with its growth in trade. The Government has been pressing companies to improve the safety of their activities in order to reduce society's loss due to occupational accidents and illnesses. Occupational safety and health is a crucial part of a workplace because every worker has to take care of his/her own safety and health. The main occupational safety and health (OSH) national policy in Malaysia is the enactment of the Occupational Safety and Health Act (OSHA) 1994. Only those companies which have excellent health and safety care have good quality and productive employees. This study investigated safety management practices in the logistics sector. The present study is concerned with the human factors to safety in the logistics industry. The authors examined the perceived safety management practices of workers in the logistics sector. The purpose was to identify the perception of safety management practices of Malaysian logistics personnel. Survey questionnaires were distributed to assess logistics personnel about management commitment. The quantitative method using the availability sampling method was applied. The data gathered from the survey were analysed using SPSS software. The responses to the survey were rated according to the Likert scale type, with '1' indicating strongly disagree and '5' indicating strongly agree. One hundred and three employees of logistics functions completed the survey. The highest mean scores were found for fire apparatus, prioritisation of safety, and safety policy. The results from this study also emphasise the importance of the management's commitment in enhancing workplace safety. Specifically, companies should maintain good relations between the employer and the employee to help reduce workplace injuries.

  12. Missing focus on Human Factors – organizational and cognitive ergonomics – in the safety management for the petroleum industry

    PubMed Central

    Johnsen, Stig O; Kilskar, Stine Skaufel; Fossum, Knut Robert

    2017-01-01

    More attention has recently been given to Human Factors in petroleum accident investigations. The Human Factors areas examined in this article are organizational, cognitive and physical ergonomics. A key question to be explored is as follows: To what degree are the petroleum industry and safety authorities in Norway focusing on these Human Factors areas from the design phase? To investigate this, we conducted an innovative exploratory study of the development of four control centres in Norwegian oil and gas industry in collaboration between users, management and Human Factors experts. We also performed a literature survey and discussion with the professional Human Factors network in Norway. We investigated the Human Factors focus, reasons for not considering Human Factors and consequences of missing Human Factors in safety management. The results revealed an immature focus and organization of Human Factors. Expertise on organizational ergonomics and cognitive ergonomics are missing from companies and safety authorities and are poorly prioritized during the development. The easy observable part of Human Factors (i.e. physical ergonomics) is often in focus. Poor focus on Human Factors in the design process creates demanding conditions for human operators and impact safety and resilience. There is lack of non-technical skills such as communication and decision-making. New technical equipment such as Closed Circuit Television is implemented without appropriate use of Human Factors standards. Human Factors expertise should be involved as early as possible in the responsible organizations. Verification and validation of Human Factors should be improved and performed from the start, by certified Human Factors experts in collaboration with the workforce. The authorities should check-back that the regulatory framework of Human Factors is communicated, understood and followed. PMID:29278242

  13. Automated Communication Tools and Computer-Based Medication Reconciliation to Decrease Hospital Discharge Medication Errors.

    PubMed

    Smith, Kenneth J; Handler, Steven M; Kapoor, Wishwa N; Martich, G Daniel; Reddy, Vivek K; Clark, Sunday

    2016-07-01

    This study sought to determine the effects of automated primary care physician (PCP) communication and patient safety tools, including computerized discharge medication reconciliation, on discharge medication errors and posthospitalization patient outcomes, using a pre-post quasi-experimental study design, in hospitalized medical patients with ≥2 comorbidities and ≥5 chronic medications, at a single center. The primary outcome was discharge medication errors, compared before and after rollout of these tools. Secondary outcomes were 30-day rehospitalization, emergency department visit, and PCP follow-up visit rates. This study found that discharge medication errors were lower post intervention (odds ratio = 0.57; 95% confidence interval = 0.44-0.74; P < .001). Clinically important errors, with the potential for serious or life-threatening harm, and 30-day patient outcomes were not significantly different between study periods. Thus, automated health system-based communication and patient safety tools, including computerized discharge medication reconciliation, decreased hospital discharge medication errors in medically complex patients. © The Author(s) 2015.

  14. Chemical plant innovative safety investments decision-support methodology.

    PubMed

    Reniers, G L L; Audenaert, A

    2009-01-01

    This article examines the extent to which investing in safety during the creation of a new chemical installation proves profitable. The authors propose a management supporting cost-benefit model that identifies and evaluates investments in safety within a chemical company. This innovative model differentiates between serious accidents and less serious accidents, thus providing an authentic image of prevention-related costs and benefits. In classic cost-benefit analyses, which do not make such differentiations, only a rudimentary image of potential profitability resulting from investments in safety is obtained. The resulting management conclusions that can be drawn from such classical analyses are of a very limited nature. The proposed model, however, is applied to a real case study and the proposed investments in safety at an appointed chemical installation are weighed against the estimated hypothetical benefits resulting from the preventive measures to be installed at the installation. In the case-study carried out in question, it would appear that the proposed prevention investments are justified. Such an economic exercise may be very important to chemical corporations trying to (further) improve their safety investments.

  15. Housing tenure as a focus for reducing inequalities in the home safety environment: evidence from Growing Up in New Zealand.

    PubMed

    Berry, Sarah; Carr, Polly Atatoa; Kool, Bridget; Mohal, Jatender; Morton, Susan; Grant, Cameron

    2017-10-01

    To determine whether specific demographic characteristics are associated with the presence or absence of household safety strategies. This study was conducted within Growing Up in New Zealand, a contemporary longitudinal study of New Zealand (NZ) children. Multivariable analyses were used to examine the maternal (self-prioritised ethnicity, education, age, self-reported health) and household (area-level deprivation, tenure, crowding, residential mobility, dwelling type) determinants of household safety strategies being present in the homes of young children. In comparison to family-owned homes, privately owned rental homes were less likely (OR=0.78; 95%CI 0.65-0.92), and government-owned rental homes were more likely (OR=1.74, 95%CI 1.25-2.41) to have eight or more household safety strategies present. Living in a privately owned rental home in NZ exposes children to an environment where there are fewer household safety strategies in place. Implications for public health: Housing tenure provides a clear target focus for improving the household safety environment for NZ children. © 2017 The Authors.

  16. How do smoking cessation medicines compare with respect to their neuropsychiatric safety? A protocol for a systematic review, network meta-analysis and cost-effectiveness analysis.

    PubMed

    Thomas, Kyla H; Caldwell, Deborah; Dalili, Michael N; Gunnell, David; Munafò, Marcus R; Stevenson, Matt; Welton, Nicky J

    2017-06-17

    Cigarette smoking is one of the leading causes of early death in the UK and worldwide. Public health guidance recommends the use of varenicline, bupropion and nicotine replacement therapy (NRT) as smoking cessation aids in the UK. Additionally, the first electronic cigarette has been licensed for use as a smoking cessation medicine. However, there are ongoing concerns about the safety of these medicines. We present a protocol for a systematic review and network meta-analysis (NMA) to determine how these smoking cessation medicines compare to each other with respect to their neuropsychiatric safety in adult smokers. Secondary aims include updating the evidence regarding the effectiveness and cardiovascular safety of these medicines for use in a cost-effectiveness analysis. We will include randomised controlled trials and observational studies with control groups comparing monotherapy with varenicline, bupropion, NRT or electronic cigarette and combination therapies to each other, placebo or usual care. The primary composite safety outcome will be serious adverse events, defined as events that resulted in death, were life threatening, required hospitalisation or resulted in significant disability or congenital/birth defect. The preferred effectiveness outcome will be sustained smoking cessation defined as abstinence for a minimum of 6 months as determined by biochemical validation. We will include trials identified by previous reviews and search relevant databases for newly published trials as well as contacting study authors to identify unpublished information. We will conduct fixed-effect and random-effect meta-analyses for each pairwise comparison of treatments and outcome; where these estimates differ, we will consider reasons for heterogeneity, quantified using the between-study variance (τ 2 ). For each outcome, we will construct a NMA in a Bayesian framework which will be compared with the pair-wise results, allowing us to rank treatments. The effectiveness estimates from the NMA will be entered into a probabilistic economic model. Ethics approval is not required for this evidence synthesis study as it involves analysis of secondary data from randomised controlled trials and observational studies. The review will make an important contribution to the knowledge base around the effectiveness, safety and cost-effectiveness of smoking cessation medicines. Results will be disseminated to the general public, healthcare practitioners and clinicians, academics, industry and policy makers. CRD42016041302. © 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.

  17. Intake of arsenic and mercury from fish and seafood in a Northern Italy community.

    PubMed

    Filippini, Tommaso; Malavolti, Marcella; Cilloni, Silvia; Wise, Lauren A; Violi, Federica; Malagoli, Carlotta; Vescovi, Luciano; Vinceti, Marco

    2018-06-01

    Regular consumption of fish is generally recommended by authorities because fish is an important source of essential nutrients. However, the presence of potentially toxic contaminants in fish has raised many concerns about the food's safety for human health. In the present study, we used a validated semi-quantitative food frequency questionnaire to assess the dietary habits of a representative sample of 719 individuals (319 males and 400 females) aged 18-87 years residing in Northern Italy. We estimated weekly dietary intakes of Arsenic (As) and Mercury (Hg), and we compared them with safety standards set by the European Food Safety Authority. In this population, fish was the main contributor to As and Hg intake. The highest levels of As were in sardine, sole/flounder and cephalopods, and of Hg in the biggest, predatory fish. About the other foods, cereals were the second contributor to the intake of these elements, especially rice for As and bread for Hg, and high levels of As and Hg were also found in mushrooms, coffee and wine. Average weekly intake of both contaminants was below recommended safety limits. Copyright © 2018 Elsevier Ltd. All rights reserved.

  18. Symbolic Interactionism: A Framework for Understanding Risk-Taking Behaviors in Farm Communities.

    PubMed

    Sorensen, Julie A; Tinc, Pamela J; Weil, Rebecca; Droullard, David

    2017-01-01

    Risk behaviors are key drivers of occupationally related injuries and illnesses, considerably impacting the uptake and success of injury interventions, technologies, and practices. This is certainly true in the agricultural sector, where farmers often ignore recommended safety practices or have even been known to disable safety technologies. Although research studies have characterized specific individual safety or risk behaviors, few studies have thoroughly examined farmers' risk and safety orientations or how these develop in response to environmental and societal exposures. This study utilizes data collected over the past decade with a variety of small to midsize farm personnel to explore the meanings that farmers ascribe to risk and safety and how these influence risk and safety behaviors. In all, over 90 interviews with farmers, farm-wives, and family members were reviewed. Researchers used a grounded theory approach to identify patterns of environmental and societal exposures, as well as their impact on farmers' risk and safety orientations. Analysis revealed exposures and orientations to risk and safety, which could be largely explained through the lens of symbolic interactionism. This framework posits that people create a sense-of-self as a way of adjusting and adapting to their environment. For farmers in this study, belief in their ability to persevere allows them to succeed, despite the considerable stressors and challenges they face each day. However, this identity can, at times, be maladaptive when it is applied to safety decisions and hazard exposures. The authors discuss the implications of this research and how it may be used to productively inform future farm safety efforts.

  19. Highway Safety Program Manual: Volume 12: Highway Design, Construction and Maintenance.

    ERIC Educational Resources Information Center

    National Highway Traffic Safety Administration (DOT), Washington, DC.

    Volume 12 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) focuses on highway design, construction and maintenance. The purpose and specific objectives of such a program are described. Federal authority in the area of highway safety and policies regarding…

  20. 31 CFR 538.519 - Aircraft and maritime safety.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false Aircraft and maritime safety. 538.519..., Authorizations, and Statements of Licensing Policy § 538.519 Aircraft and maritime safety. Specific licenses may... technology to insure the safety of civil aviation and safe operation of U.S.-origin commercial passenger...

  1. 75 FR 55366 - In the Matter of Mark M. Ficek; Order Prohibiting Involvement in NRC-Licensed Activities...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-10

    ... (Effective Immediately) Mr. Mark M. Ficek is the President, owner, and former radiation safety officer (RSO... new radiation safety officer, and due to expire on February 28, 2016. The license authorizes Mattingly... assessing Mattingly's entire radiation safety program, providing radiation safety training to the Mattingly...

  2. Highway Safety Program Manual: Volume 15: Police Traffic Services.

    ERIC Educational Resources Information Center

    National Highway Traffic Safety Administration (DOT), Washington, DC.

    Volume 15 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) focuses on police traffic services. The purpose and objectives of a police services program are described. Federal authority in the areas of highway safety and policies regarding a police traffic…

  3. Highway Safety Program Manual: Volume 6: Codes and Laws.

    ERIC Educational Resources Information Center

    National Highway Traffic Safety Administration (DOT), Washington, DC.

    Volume 6 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred safety practices) concentrates on codes and laws. The purpose and specific objectives of the Codes and Laws Program, Federal authority in the area of highway safety, and policies regarding traffic regulation are described.…

  4. The Influence of Safety, Efficacy, and Medical Condition Severity on Natural versus Synthetic Drug Preference.

    PubMed

    Meier, Brian P; Lappas, Courtney M

    2016-11-01

    Research indicates that there is a preference for natural v. synthetic products, but the influence of this preference on drug choice in the medical domain is largely unknown. We present 5 studies in which participants were asked to consider a hypothetical situation in which they had a medical issue requiring pharmacological therapy. Participants ( N = 1223) were asked to select a natural, plant-derived, or synthetic drug. In studies 1a and 1b, approximately 79% of participants selected the natural v. synthetic drug, even though the safety and efficacy of the drugs were identical. Furthermore, participants rated the natural drug as safer than the synthetic drug, and as that difference increased, the odds of choosing the natural over synthetic drug increased. In studies 2 and 3, approximately 20% of participants selected the natural drug even when they were informed that it was less safe (study 2) or less effective (study 3) than the synthetic drug. Finally, in study 4, approximately 65% of participants chose a natural over synthetic drug regardless of the severity of a specific medical condition (mild v. severe hypertension), and this choice was predicted by perceived safety and efficacy differences. Overall, these data indicate that there is a bias for natural over synthetic drugs. This bias could have implications for drug choice and usage. © The Author(s) 2015.

  5. Linking Environmental Sustainability, Health, and Safety Data in Health Care: A Research Roadmap.

    PubMed

    Kaplan, Susan B; Forst, Linda

    2017-08-01

    Limited but growing evidence demonstrates that environmental sustainability in the health-care sector can improve worker and patient health and safety. Yet these connections are not appreciated or understood by decision makers in health-care organizations or oversight agencies. Several studies demonstrate improvements in quality of care, staff satisfaction, and work productivity related to environmental improvements in the health-care sector. A pilot study conducted by the authors found that already-collected data could be used to evaluate impacts of environmental sustainability initiatives on worker and patient health and safety, yet few hospitals do so. Future research should include a policy analysis of laws that could drive efforts to integrate these areas, elucidation of organizational models that promote sharing of environmental and health and safety data, and development of tools and methods to enable systematic linkage and evaluation of these data to expand the evidence base and improve the hospital environment.

  6. Healthcare databases in Europe for studying medicine use and safety during pregnancy.

    PubMed

    Charlton, Rachel A; Neville, Amanda J; Jordan, Sue; Pierini, Anna; Damase-Michel, Christine; Klungsøyr, Kari; Andersen, Anne-Marie Nybo; Hansen, Anne Vinkel; Gini, Rosa; Bos, Jens H J; Puccini, Aurora; Hurault-Delarue, Caroline; Brooks, Caroline J; de Jong-van den Berg, Lolkje T W; de Vries, Corinne S

    2014-06-01

    The aim of this study was to describe a number of electronic healthcare databases in Europe in terms of the population covered, the source of the data captured and the availability of data on key variables required for evaluating medicine use and medicine safety during pregnancy. A sample of electronic healthcare databases that captured pregnancies and prescription data was selected on the basis of contacts within the EUROCAT network. For each participating database, a database inventory was completed. Eight databases were included, and the total population covered was 25 million. All databases recorded live births, seven captured stillbirths and five had full data available on spontaneous pregnancy losses and induced terminations. In six databases, data were usually available to determine the date of the woman's last menstrual period, whereas in the remainder, algorithms were needed to establish a best estimate for at least some pregnancies. In seven databases, it was possible to use data recorded in the databases to identify pregnancies where the offspring had a congenital anomaly. Information on confounding variables was more commonly available in databases capturing data recorded by primary-care practitioners. All databases captured maternal co-prescribing and a measure of socioeconomic status. This study suggests that within Europe, electronic healthcare databases may be valuable sources of data for evaluating medicine use and safety during pregnancy. The suitability of a particular database, however, will depend on the research question, the type of medicine to be evaluated, the prevalence of its use and any adverse outcomes of interest. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.

  7. Overview of the "epigenetic end points in toxicologic pathology and relevance to human health" session of the 2014 Society Of Toxicologic Pathology Annual Symposium.

    PubMed

    Hoenerhoff, Mark J; Hartke, James

    2015-01-01

    The theme of the Society of Toxicologic Pathology 2014 Annual Symposium was "Translational Pathology: Relevance of Toxicologic Pathology to Human Health." The 5th session focused on epigenetic end points in biology, toxicity, and carcinogenicity, and how those end points are relevant to human exposures. This overview highlights the various presentations in this session, discussing integration of epigenetics end points in toxicologic pathology studies, investigating the role of epigenetics in product safety assessment, epigenetic changes in cancers, methodologies to detect them, and potential therapies, chromatin remodeling in development and disease, and epigenomics and the microbiome. The purpose of this overview is to discuss the application of epigenetics to toxicologic pathology and its utility in preclinical or mechanistic based safety, efficacy, and carcinogenicity studies. © 2014 by The Author(s).

  8. George Washington and Civil-Military Relations During the Revolutionary War: A Study of the Establishment of Civilian Control

    DTIC Science & Technology

    2012-06-08

    Washington to the New York Committee of Safety , April 20, 1776 Introduction On June 14, 1775, the Second Continental Congress officially and collectively...guidance on providing food and shelter for the army at Congressional expense, granted him the authorities to take prisoners and to promote officers...states centered on the various state legislative bodies such New York’s Committee of Safety or the Massachusetts Provincial 77 Congress. However

  9. Efficacy and safety testing of mycotoxin-detoxifying agents in broilers following the European Food Safety Authority guidelines.

    PubMed

    Osselaere, A; Devreese, M; Watteyn, A; Vandenbroucke, V; Goossens, J; Hautekiet, V; Eeckhout, M; De Saeger, S; De Baere, S; De Backer, P; Croubels, S

    2012-08-01

    Contamination of feeds with mycotoxins is a worldwide problem and mycotoxin-detoxifying agents are used to decrease their negative effect. The European Food Safety Authority recently stated guidelines and end-points for the efficacy testing of detoxifiers. Our study revealed that plasma concentrations of deoxynivalenol and deepoxy-deoxynivalenol were too low to assess efficacy of 2 commercially available mycotoxin-detoxifying agents against deoxynivalenol after 3 wk of continuous feeding of this mycotoxin at concentrations of 2.44±0.70 mg/kg of feed and 7.54±2.20 mg/kg of feed in broilers. This correlates with the poor absorption of deoxynivalenol in poultry. A safety study with 2 commercially available detoxifying agents and veterinary drugs showed innovative results with regard to the pharmacokinetics of 2 antibiotics after oral dosing in the drinking water. The plasma and kidney tissue concentrations of oxytetracycline were significantly higher in broilers receiving a biotransforming agent in the feed compared with control birds. For amoxicillin, the plasma concentrations were significantly higher for broilers receiving an adsorbing agent in comparison to birds receiving the biotransforming agent, but not to the control group. Mycotoxin-detoxifying agents can thus interact with the oral bioavailability of antibiotics depending on the antibiotic and detoxifying agent, with possible adverse effects on the health of animals and humans.

  10. Delivering safe and effective test-result communication, management and follow-up: a mixed-methods study protocol.

    PubMed

    Dahm, Maria R; Georgiou, Andrew; Westbrook, Johanna I; Greenfield, David; Horvath, Andrea R; Wakefield, Denis; Li, Ling; Hillman, Ken; Bolton, Patrick; Brown, Anthony; Jones, Graham; Herkes, Robert; Lindeman, Robert; Legg, Michael; Makeham, Meredith; Moses, Daniel; Badmus, Dauda; Campbell, Craig; Hardie, Rae-Anne; Li, Julie; McCaughey, Euan; Sezgin, Gorkem; Thomas, Judith; Wabe, Nasir

    2018-02-15

    The failure to follow-up pathology and medical imaging test results poses patient-safety risks which threaten the effectiveness, quality and safety of patient care. The objective of this project is to: (1) improve the effectiveness and safety of test-result management through the establishment of clear governance processes of communication, responsibility and accountability; (2) harness health information technology (IT) to inform and monitor test-result management; (3) enhance the contribution of consumers to the establishment of safe and effective test-result management systems. This convergent mixed-methods project triangulates three multistage studies at seven adult hospitals and one paediatric hospital in Australia.Study 1 adopts qualitative research approaches including semistructured interviews, focus groups and ethnographic observations to gain a better understanding of test-result communication and management practices in hospitals, and to identify patient-safety risks which require quality-improvement interventions.Study 2 analyses linked sets of routinely collected healthcare data to examine critical test-result thresholds and test-result notification processes. A controlled before-and-after study across three emergency departments will measure the impact of interventions (including the use of IT) developed to improve the safety and quality of test-result communication and management processes.Study 3 adopts a consumer-driven approach, including semistructured interviews, and the convening of consumer-reference groups and community forums. The qualitative data will identify mechanisms to enhance the role of consumers in test-management governance processes, and inform the direction of the research and the interpretation of findings. Ethical approval has been granted by the South Eastern Sydney Local Health District Human Research Ethics Committee and Macquarie University. Findings will be disseminated in academic, industry and consumer journals, newsletters and conferences. © 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 expressly granted.

  11. 29 CFR 1952.295 - Level of Federal enforcement.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... regard to occupational safety and health issues covered by the Nevada plan. OSHA retains full authority... directed to any private sector maritime activities (occupational safety and health standards comparable to...

  12. 29 CFR 1952.295 - Level of Federal enforcement.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... regard to occupational safety and health issues covered by the Nevada plan. OSHA retains full authority... directed to any private sector maritime activities (occupational safety and health standards comparable to...

  13. Trends in readmission rates for safety net hospitals and non-safety net hospitals in the era of the US Hospital Readmission Reduction Program: a retrospective time series analysis using Medicare administrative claims data from 2008 to 2015.

    PubMed

    Salerno, Amy M; Horwitz, Leora I; Kwon, Ji Young; Herrin, Jeph; Grady, Jacqueline N; Lin, Zhenqiu; Ross, Joseph S; Bernheim, Susannah M

    2017-07-13

    To compare trends in readmission rates among safety net and non-safety net hospitals under the US Hospital Readmission Reduction Program (HRRP). A retrospective time series analysis using Medicare administrative claims data from January 2008 to June 2015. We examined 3254 US hospitals eligible for penalties under the HRRP, categorised as safety net or non-safety net hospitals based on the hospital's proportion of patients with low socioeconomic status. Admissions for Medicare fee-for-service patients, age ≥65 years, discharged alive, who had a valid five-digit zip code and did not have a principal discharge diagnosis of cancer or psychiatric illness were included, for a total of 52 516 213 index admissions. Mean hospital-level, all-condition, 30-day risk-adjusted standardised unplanned readmission rate, measured quarterly, along with quarterly rate of change, and an interrupted time series examining: April-June 2010, after HRRP was passed, and October-December 2012, after HRRP penalties were implemented. 58.0% (SD 15.3) of safety net hospitals and 17.1% (SD 10.4) of non-safety net hospitals' patients were in the lowest quartile of socioeconomic status. The mean safety net hospital standardised readmission rate declined from 17.0% (SD 3.7) to 13.6% (SD 3.6), whereas the mean non-safety net hospital declined from 15.4% (SD 3.0) to 12.7% (SD 2.5). The absolute difference in rates between safety net and non-safety net hospitals declined from 1.6% (95% CI 1.3 to 1.9) to 0.9% (0.7 to 1.2). The quarterly decline in standardised readmission rates was 0.03 percentage points (95% CI 0.03 to 0.02, p<0.001) greater among safety net hospitals over the entire study period, and no differential change among safety net and non-safety net hospitals was found after either HRRP was passed or penalties enacted. Since HRRP was passed and penalties implemented, readmission rates for safety net hospitals have decreased more rapidly than those for non-safety net hospitals. © 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.

  14. Using the Job Demands-Resources model to investigate risk perception, safety climate and job satisfaction in safety critical organizations.

    PubMed

    Nielsen, Morten Birkeland; Mearns, Kathryn; Matthiesen, Stig Berge; Eid, Jarle

    2011-10-01

    Using the Job Demands-Resources model (JD-R) as a theoretical framework, this study investigated the relationship between risk perception as a job demand and psychological safety climate as a job resource with regard to job satisfaction in safety critical organizations. In line with the JD-R model, it was hypothesized that high levels of risk perception is related to low job satisfaction and that a positive perception of safety climate is related to high job satisfaction. In addition, it was hypothesized that safety climate moderates the relationship between risk perception and job satisfaction. Using a sample of Norwegian offshore workers (N = 986), all three hypotheses were supported. In summary, workers who perceived high levels of risk reported lower levels of job satisfaction, whereas this effect diminished when workers perceived their safety climate as positive. Follow-up analyses revealed that this interaction was dependent on the type of risks in question. The results of this study supports the JD-R model, and provides further evidence for relationships between safety-related concepts and work-related outcomes indicating that organizations should not only develop and implement sound safety procedures to reduce the effects of risks and hazards on workers, but can also enhance other areas of organizational life through a focus on safety. © 2011 The Authors. Scandinavian Journal of Psychology © 2011 The Scandinavian Psychological Associations.

  15. Applying Goldwater-Nichols Reforms to Foster Interagency Cooperation Between Public Safety Agencies in New York City

    DTIC Science & Technology

    2007-03-01

    release; distribution is unlimited APPLYING GOLDWATER-NICHOLS REFORMS TO FOSTER INTERAGENCY COOPERATION BETWEEN PUBLIC SAFTEY AGENCIES IN NEW YORK...NAVAL POSTGRADUATE SCHOOL MONTEREY, CALIFORNIA THESIS Approved for public release; distribution is unlimited APPLYING GOLDWATER... Applying Goldwater-Nichols Reforms to Foster Interagency Cooperation Between Public Safety Agencies in New York City 6. AUTHOR(S) Joseph P

  16. Scientific Method and the Regulation of Health and Nutritional Claims by the European Food Safety Authority

    ERIC Educational Resources Information Center

    Hoad, Darren

    2011-01-01

    The protection of European consumers from the false or misleading scientific and nutritional claims of food manufacturers took a step forward with the recent opinions of the European Food Safety Authority (EFSA). As a risk assessment agency, the EFSA recently assessed and rejected a vast number of food claim forcing the withdrawal of many claims…

  17. 15 CFR 270.325 - Notice of authority to enter and inspect property where building components, materials, artifacts...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Collection and Preservation of Evidence... pursuant to the Act, any member of a Team, or any other person authorized by the Director to support a Team... property to be inspected and to carry out the duties of the Team; (2) During reasonable hours, inspect any...

  18. 15 CFR 270.325 - Notice of authority to enter and inspect property where building components, materials, artifacts...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Collection and Preservation of Evidence... pursuant to the Act, any member of a Team, or any other person authorized by the Director to support a Team... property to be inspected and to carry out the duties of the Team; (2) During reasonable hours, inspect any...

  19. 15 CFR 270.325 - Notice of authority to enter and inspect property where building components, materials, artifacts...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Collection and Preservation of Evidence... pursuant to the Act, any member of a Team, or any other person authorized by the Director to support a Team... property to be inspected and to carry out the duties of the Team; (2) During reasonable hours, inspect any...

  20. 15 CFR 270.325 - Notice of authority to enter and inspect property where building components, materials, artifacts...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Collection and Preservation of Evidence... pursuant to the Act, any member of a Team, or any other person authorized by the Director to support a Team... property to be inspected and to carry out the duties of the Team; (2) During reasonable hours, inspect any...

  1. 15 CFR 270.325 - Notice of authority to enter and inspect property where building components, materials, artifacts...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Collection and Preservation of Evidence... pursuant to the Act, any member of a Team, or any other person authorized by the Director to support a Team... property to be inspected and to carry out the duties of the Team; (2) During reasonable hours, inspect any...

  2. 49 CFR Appendix to Subpart H of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Non-North America-Domiciled...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Evaluation Criteria for Non-North America-Domiciled Motor Carriers Appendix to Subpart H of Part 385... Special Rules for New Entrant Non-North America-Domiciled Carriers Pt. 385, Subpt. H, App. Appendix to Subpart H of Part 385—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Non-North...

  3. Quality management and perceptions of teamwork and safety climate in European hospitals.

    PubMed

    Kristensen, Solvejg; Hammer, Antje; Bartels, Paul; Suñol, Rosa; Groene, Oliver; Thompson, Caroline A; Arah, Onyebuchi A; Kutaj-Wasikowska, Halina; Michel, Philippe; Wagner, Cordula

    2015-12-01

    This study aimed to investigate the associations of quality management systems with teamwork and safety climate, and to describe and compare differences in perceptions of teamwork climate and safety climate among clinical leaders and frontline clinicians. We used a multi-method, cross-sectional approach to collect survey data of quality management systems and perceived teamwork and safety climate. Our data analyses included descriptive and multilevel regression methods. Data on implementation of quality management system from seven European countries were evaluated including patient safety culture surveys from 3622 clinical leaders and 4903 frontline clinicians. Perceived teamwork and safety climate. Teamwork climate was reported as positive by 67% of clinical leaders and 43% of frontline clinicians. Safety climate was perceived as positive by 54% of clinical leaders and 32% of frontline clinicians. We found positive associations between implementation of quality management systems and teamwork and safety climate. Our findings, which should be placed in a broader clinical quality improvement context, point to the importance of quality management systems as a supportive structural feature for promoting teamwork and safety climate. To gain a deeper understanding of this association, further qualitative and quantitative studies using longitudinally collected data are recommended. The study also confirms that more clinical leaders than frontline clinicians have a positive perception of teamwork and safety climate. Such differences should be accounted for in daily clinical practice and when tailoring initiatives to improve teamwork and safety climate. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

  4. District-Owned vs Contracted Bus Service.

    ERIC Educational Resources Information Center

    Lehman, Tom; Harkin, Gary

    1979-01-01

    A synopsis of the results of a study conducted for the Bozeman, Montana, Public Schools. The study evaluated the feasibility of a district-owned vs a contracted pupil transportation system. Various aspects of school transportation were analyzed by their relationship to safety, control, service, and cost. (Author/MLF)

  5. 76 FR 64431 - Reorganization of Title 30: Bureaus of Safety and Environmental Enforcement and Ocean Energy...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-18

    ...This rule contains regulations that will be under the authority of two newly formed Bureaus, the Bureau of Safety and Environmental Enforcement (BSEE) and the Bureau of Ocean Energy Management (BOEM), both within the Department of the Interior. On May 19, 2010, the Secretary of the Interior announced the separation of the responsibilities performed by the Bureau of Ocean Energy Management, Regulation and Enforcement (BOEMRE) (formerly the Minerals Management Service) into three new separate organizations: Office of Natural Resources Revenue (ONRR), Bureau of Ocean Energy Management (BOEM), and Bureau of Safety and Environmental Enforcement (BSEE). Those regulations that will apply to the authority of BSEE organization will remain in 30 CFR chapter II, but be retitled ``Bureau of Safety and Environmental Enforcement.'' This rule removes from chapter II those regulations that will apply to the authority of BOEM and recodifies them into a new 30 CFR chapter V entitled ``Bureau of Ocean Energy Management.''

  6. Another Approach to Enhance Airline Safety: Using Management Safety Tools

    NASA Technical Reports Server (NTRS)

    Lu, Chien-tsug; Wetmore, Michael; Przetak, Robert

    2006-01-01

    The ultimate goal of conducting an accident investigation is to prevent similar accidents from happening again and to make operations safer system-wide. Based on the findings extracted from the investigation, the "lesson learned" becomes a genuine part of the safety database making risk management available to safety analysts. The airline industry is no exception. In the US, the FAA has advocated the usage of the System Safety concept in enhancing safety since 2000. Yet, in today s usage of System Safety, the airline industry mainly focuses on risk management, which is a reactive process of the System Safety discipline. In order to extend the merit of System Safety and to prevent accidents beforehand, a specific System Safety tool needs to be applied; so a model of hazard prediction can be formed. To do so, the authors initiated this study by reviewing 189 final accident reports from the National Transportation Safety Board (NTSB) covering FAR Part 121 scheduled operations. The discovered accident causes (direct hazards) were categorized into 10 groups Flight Operations, Ground Crew, Turbulence, Maintenance, Foreign Object Damage (FOD), Flight Attendant, Air Traffic Control, Manufacturer, Passenger, and Federal Aviation Administration. These direct hazards were associated with 36 root factors prepared for an error-elimination model using Fault Tree Analysis (FTA), a leading tool for System Safety experts. An FTA block-diagram model was created, followed by a probability simulation of accidents. Five case studies and reports were provided in order to fully demonstrate the usefulness of System Safety tools in promoting airline safety.

  7. The increase in prescriptions of bisphosphonates and the incidence proportion of osteonecrosis of the jaw after risk communication activities in Japan: a hospital-based cohort study†

    PubMed Central

    Sumi, Eriko; Yamazaki, Toru; Tanaka, Shiro; Yamamoto, Keiichi; Nakayama, Takeo; Bessho, Kazuhisa; Yokode, Masayuki

    2014-01-01

    Purpose The purpose of this study was to investigate the impact of risk communication about bisphosphonate (BP)-related osteonecrosis of the jaw (ONJ) on the number of reported cases to the Drug Adverse Reactions Reporting System and on the incidence proportion of ONJ in a hospital-based cohort study in Japan. Method We conducted a survey of the safety information on BP-related ONJ available from regulatory authorities, pharmaceutical manufacturers and academic associations. We also performed a trend analysis of a dataset from the Drug Adverse Reactions Reporting System and a sub-analysis, using previously constructed data from a retrospective cohort study. Results Risk communication from pharmaceutical manufacturers and academic associations began within 1 year after revisions were made to the package inserts, in October 2006. Twenty times more cases of ONJ have been reported to regulatory authority since 2007, compared with the period before 2007. In our cohort, the incidence proportion of ONJ during and after 2009 was four times greater than before 2009. During this period, BPs were frequently prescribed, whereas there was no increase in the use of alternative agents, such as selective estrogen receptor modulators. Conclusion ONJ was increasingly diagnosed after risk communication efforts, but the impact of the communications was not clear. Safety notifications were diligently disseminated after the package insert was revised. However, there was no surveillance for ONJ before the revision. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. PMID:24399628

  8. An Open-Label Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (RECAP).

    PubMed

    Costabel, Ulrich; Albera, Carlo; Lancaster, Lisa H; Lin, Chin-Yu; Hormel, Philip; Hulter, Henry N; Noble, Paul W

    2017-01-01

    RECAP (NCT00662038) was an open-label extension study in patients with idiopathic pulmonary fibrosis (IPF) who completed either the Assessment of Pirfenidone to Confirm Efficacy and Safety in Idiopathic Pulmonary Fibrosis (ASCEND) 016 phase 3 trial or the Clinical Studies Assessing Pirfenidone in Idiopathic Pulmonary Fibrosis: Research of Efficacy and Safety Outcomes (CAPACITY) 004/006 phase 3 trials. To obtain long-term safety data for pirfenidone in patients with IPF in RECAP. Of the 1,334 patients who participated in the phase 3 trials, 1,058 entered RECAP. The final analysis from enrollment (September 2008) to June 2015 is presented. Mean (SD) and median (range) pirfenidone exposures in RECAP were 122 (98) weeks and 88 (>0 to 349) weeks, respectively, with a mean daily dose of 2,091.1 mg. Cumulative total exposure was 2,482 patient exposure years (PEY). The treatment-emergent adverse event (TEAE) rate was 701.9 per 100 PEY. The serious TEAE rate was 53.5 per 100 PEY, with the most common serious TEAE being IPF (11.1 per 100 PEY). Of the 231 deaths (9.3 per 100 PEY), the most common cause was IPF (5.4 per 100 PEY). The treatment discontinuation rate due to a TEAE was 17.9 per 100 PEY; discontinuations were due to IPF (7.2 per 100 PEY), pneumonia, respiratory failure, acute respiratory failure, rash (0.5 per 100 PEY each), and nausea (0.4 per 100 PEY). For patients from CAPACITY 004/006 who entered RECAP, the mean change in percent predicted forced vital capacity from RECAP baseline at 180 weeks was -9.6%. Median on-treatment survival from the first pirfenidone dose in RECAP was 77.2 months. RECAP provides long-term follow-up and safety data for pirfenidone that were consistent with the known profile, with no new safety signals observed. © 2017 The Author(s) Published by S. Karger AG, Basel.

  9. 29 CFR 1952.105 - Level of Federal enforcement.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...), final approval relinquishes Federal OSHA authority with regard to occupational safety and health issues... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... safety and health standards which have been promulgated under Section 6 of the Act (with the exception of...

  10. 29 CFR 1903.3 - Authority for inspection.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... conducted by Department of Labor Compliance Safety and Health Officers and representatives of the Secretary... agency of the United States Government in the interest of national security, Compliance Safety and Health...

  11. 30 CFR 48.26 - Experienced miner training.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR EDUCATION AND TRAINING... observed and explained. (2) Mandatory health and safety standards. The course shall include the mandatory health and safety standards pertinent to the tasks to be assigned. (3) Authority and responsibility of...

  12. 29 CFR 1903.3 - Authority for inspection.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... conducted by Department of Labor Compliance Safety and Health Officers and representatives of the Secretary... agency of the United States Government in the interest of national security, Compliance Safety and Health...

  13. 29 CFR 1903.3 - Authority for inspection.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... conducted by Department of Labor Compliance Safety and Health Officers and representatives of the Secretary... agency of the United States Government in the interest of national security, Compliance Safety and Health...

  14. 29 CFR 1903.3 - Authority for inspection.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... conducted by Department of Labor Compliance Safety and Health Officers and representatives of the Secretary... agency of the United States Government in the interest of national security, Compliance Safety and Health...

  15. 30 CFR 48.26 - Experienced miner training.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR EDUCATION AND TRAINING... observed and explained. (2) Mandatory health and safety standards. The course shall include the mandatory health and safety standards pertinent to the tasks to be assigned. (3) Authority and responsibility of...

  16. 29 CFR 1903.3 - Authority for inspection.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... conducted by Department of Labor Compliance Safety and Health Officers and representatives of the Secretary... agency of the United States Government in the interest of national security, Compliance Safety and Health...

  17. 78 FR 65429 - Pipeline Safety: Request for Special Permit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-31

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2010-0041] Pipeline Safety: Request for Special Permit AGENCY: Pipeline and Hazardous Materials...-0041 Williams Gas Pipeline 49 CFR 192.150........ To authorize the extension Company, LLC (WGP). of a...

  18. 1996 motor vehicle occupant safety survey. Volume 4, Crash injury and emergency medical services report

    DOT National Transportation Integrated Search

    1997-11-01

    Author's abstract: The National Highway Traffic Safety Administration (NHTSA) commissioned the research firm of Schulman, Ronca & Bucuvalas, Inc. (SRBI) to conduct the 1996 Motor Vehicle Occupant Safety Survey. Between November 4, 1996 and January 5,...

  19. 29 CFR 1915.1 - Purpose and authority.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) OCCUPATIONAL SAFETY AND HEALTH STANDARDS FOR SHIPYARD EMPLOYMENT General Provisions § 1915.1... U.S.C. 941) and occupational safety and health standards issued by the Secretary pursuant to section...

  20. 29 CFR 1915.1 - Purpose and authority.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) OCCUPATIONAL SAFETY AND HEALTH STANDARDS FOR SHIPYARD EMPLOYMENT General Provisions § 1915.1... U.S.C. 941) and occupational safety and health standards issued by the Secretary pursuant to section...

  1. State of the Art: Recent Legislation on Workers' Health and Safety.

    ERIC Educational Resources Information Center

    Parmeggiani, L.

    1982-01-01

    Reviews present trends in occupational health and safety legislation. Discusses the role of the state, the development of workers' participation, trends in the organization of occupational health services, and methods and objectives of occupational safety and health. (Author/JOW)

  2. Refugee settlement workers' perspectives on home safety issues for people from refugee backgrounds.

    PubMed

    Campbell, Emma Jean; Turpin, Merrill June

    2010-12-01

    Refugees experience higher levels of emotional, psychological and physical distress than the general migrant population during settlement in a new country. Safety in the home can be a major concern and is an issue of which occupational therapists should be aware. Occupational therapists working with refugees in many contexts feel unprepared and overwhelmed. As refugee settlement workers attend to home safety of refugees during the settlement process, this study aimed to develop an in-depth understanding of their perceptions of this issue. Such information can contribute to occupational therapists' knowledge and practice when working with refugees. An exploratory qualitative case study approach used 16 semi-structured interviews and observation of a settlement worker assisting newly arrived refugees. Participants were settlement service staff (an occupational therapist, case coordinators and cultural support workers). Three themes are reported: considerations for safety in the homes of refugees; factors influencing home safety for refugees; and sensitivity to culture. Participants described tailoring home safety-related services to each individual based on factors that influence home safety and sensitivity to culture. Awareness of home safety issues can increase cultural competence and inform practice and policy. © 2010 The Authors. Australian Occupational Therapy Journal © 2010 Australian Association of Occupational Therapists.

  3. Challenges on the path to cultural safety in nursing education.

    PubMed

    Arieli, D; Friedman, V J; Hirschfeld, M J

    2012-06-01

    The purpose of this study is to identify central challenges to be addressed in cultural safety education. In recent years, the idea of cultural safety has received increased attention as a way of dealing with diversity in the nursing profession, especially in divided societies. The idea of cultural safety goes beyond recognizing and appreciating difference, to an attempt to grappling with deeper issues like inequality, conflict and histories of oppression. The paper is based on formative evaluation, using action research, of an academic nursing programme in Israel, involving Jewish and Arab students. Part of this research dealt with the integration of cultural safety education into the curriculum. The study revealed four challenges in cultural safety education: making it safe for minorities to present their culture to the majority group ('the ambassador's dilemma'), dealing with tendency of groups to deny the existence of conflict ('the one big happy family fantasy'), making dynamics of oppression discussable ('the oppressed and the oppressor') and creating conditions in which people can freely choose their individual and group identities ('the threat of identity'). Cultural safety education may be experienced as unsafe for many participants. Better understanding of the challenges of cultural safety education is necessary for making it more effective. © 2012 The Authors. International Nursing Review © 2012 International Council of Nurses.

  4. Highway Safety Program Manual: Volume 16: Debris Hazard Control and Cleanup.

    ERIC Educational Resources Information Center

    National Highway Traffic Safety Administration (DOT), Washington, DC.

    Volume 16 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on debris hazard control and cleanup. The purpose and objectives of such a program are outlined. Federal authority in the area of highway safety and policies regarding a debris control…

  5. 76 FR 1460 - Maritime Advisory Committee for Occupational Safety and Health (MACOSH); Committee Reestablishment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-10

    ... duties imposed by the Occupational Safety and Health (OSH) Act of 1970 (29 U.S.C. 655, 656). Authority to...(b) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 655(b)(1), 656(b)), the Federal... DEPARTMENT OF LABOR Occupational Safety and Health Administration Maritime Advisory Committee for...

  6. 77 FR 28451 - Unsatisfactory Safety Rating; Revocation of Operating Authority Registration; Technical Amendments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-14

    ... carrier for failure to comply with safety fitness requirements; if the Agency determines that a motor carrier is ``Unfit'' based on its Safety Fitness Determination procedures, the Agency must revoke the... failure to comply with safety fitness requirements. See 49 U.S.C. 13905(f)(1)(B) and (3). The implementing...

  7. 48 CFR 50.205-3 - Authorization of offers contingent upon SAFETY Act designation or certification before contract...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...— (i) For offers contingent upon SAFETY Act designation, a pre-qualification designation notice or a block designation; or (ii) For offers contingent upon SAFETY Act certification, a block certification... contingent upon SAFETY Act designation or certification before contract award. 50.205-3 Section 50.205-3...

  8. Agricultural occupational health and safety perspectives among Latino-American youth.

    PubMed

    Perla, M E; Iman, Esmeralda; Campos, Leticia; Perkins, Alexandra; Liebman, Amy K; Miller, Mary E; Beaudet, Nancy J; Karr, Catherine J

    2015-01-01

    Agricultural work is one of the most dangerous jobs for adolescents. Through a university-community partnership, the authors surveyed young primarily acculturated Latino-American farmworkers 14 to 18 years of age regarding their agricultural work experience. Topics included occupational health and safety education, work history, and information sources. The authors also evaluated the Rapid Clinical Assessment Tool (RCAT), a pictorial tool for identifying agricultural tasks to enhance discussion with clinical providers. One hundred forty youth with farmwork experience completed the survey; 6% reported a previous work-related injury or illness and 53% reported receiving some workplace health and safety training. Correct identification of legally restricted duties for youth varied but were generally low: participants identified working alone past 8 pm (57%), driving a forklift (56%), doing roofing work (39%), working in freezers (34%), and driving a delivery vehicle (30%). The Internet was identified as the most likely and reliable place youth would go to find information on workplace health and safety. Few (15%) reported clinician-initiated conversations on occupational health; however, a high proportion responded positively to questions regarding the usefulness of the RCAT for this purpose. This study highlights the need for workplace health and safety guidance for youth employed in agriculture. The results support Internet-based outreach and use of the RCAT to help facilitate occupational health discussions in clinical settings.

  9. Agricultural Occupational Health and Safety Perspectives Among Latino-American Youth

    PubMed Central

    Perla, M. E.; Iman, Esmeralda; Campos, Leticia; Perkins, Alexandra; Liebman, Amy K.; Miller, Mary E.; Beaudet, Nancy J.; Karr, Catherine J.

    2018-01-01

    Agricultural work is one of the most dangerous jobs for adolescents. Through a university-community partnership, the authors surveyed young primarily acculturated Latino-American farmworkers 14 to 18 years of age regarding their agricultural work experience. Topics included occupational health and safety education, work history, and information sources. The authors also evaluated the Rapid Clinical Assessment Tool (RCAT), a pictorial tool for identifying agricultural tasks to enhance discussion with clinical providers. One hundred forty youth with farmwork experience completed the survey; 6% reported a previous work-related injury or illness and 53% reported receiving some workplace health and safety training. Correct identification of legally restricted duties for youth varied but were generally low: participants identified working alone past 8 PM (57%), driving a forklift (56%), doing roofing work (39%), working in freezers (34%), and driving a delivery vehicle (30%). The Internet was identified as the most likely and reliable place youth would go to find information on workplace health and safety. Few (15%) reported clinician-initiated conversations on occupational health; however, a high proportion responded positively to questions regarding the usefulness of the RCAT for this purpose. This study highlights the need for workplace health and safety guidance for youth employed in agriculture. The results support Internet-based outreach and use of the RCAT to help facilitate occupational health discussions in clinical settings. PMID:25906275

  10. Providing feedback following Leadership WalkRounds is associated with better patient safety culture, higher employee engagement and lower burnout.

    PubMed

    Sexton, J Bryan; Adair, Kathryn C; Leonard, Michael W; Frankel, Terri Christensen; Proulx, Joshua; Watson, Sam R; Magnus, Brooke; Bogan, Brittany; Jamal, Maleek; Schwendimann, Rene; Frankel, Allan S

    2018-04-01

    There is a poorly understood relationship between Leadership WalkRounds (WR) and domains such as safety culture, employee engagement, burnout and work-life balance. This cross-sectional survey study evaluated associations between receiving feedback about actions taken as a result of WR and healthcare worker assessments of patient safety culture, employee engagement, burnout and work-life balance, across 829 work settings. 16 797 of 23 853 administered surveys were returned (70.4%). 5497 (32.7% of total) reported that they had participated in WR, and 4074 (24.3%) reported that they participated in WR with feedback. Work settings reporting more WR with feedback had substantially higher safety culture domain scores (first vs fourth quartile Cohen's d range: 0.34-0.84; % increase range: 15-27) and significantly higher engagement scores for four of its six domains (first vs fourth quartile Cohen's d range: 0.02-0.76; % increase range: 0.48-0.70). This WR study of patient safety and organisational outcomes tested relationships with a comprehensive set of safety culture and engagement metrics in the largest sample of hospitals and respondents to date. Beyond measuring simply whether WRs occur, we examine WR with feedback, as WR being done well . We suggest that when WRs are conducted, acted on, and the results are fed back to those involved, the work setting is a better place to deliver and receive care as assessed across a broad range of metrics, including teamwork, safety, leadership, growth opportunities, participation in decision-making and the emotional exhaustion component of burnout. Whether WR with feedback is a manifestation of better norms, or a cause of these norms, is unknown, but the link is demonstrably potent. © 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 expressly granted.

  11. 10 CFR 60.31 - Construction authorization.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Construction authorization. 60.31 Section 60.31 Energy... REPOSITORIES Licenses Construction Authorization § 60.31 Construction authorization. Upon review and... authorize construction if it determines: (a) Safety. That there is reasonable assurance that the types and...

  12. 10 CFR 60.31 - Construction authorization.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Construction authorization. 60.31 Section 60.31 Energy... REPOSITORIES Licenses Construction Authorization § 60.31 Construction authorization. Upon review and... authorize construction if it determines: (a) Safety. That there is reasonable assurance that the types and...

  13. Complexity perplexity: a systematic review to describe the measurement of medication regimen complexity.

    PubMed

    Paquin, Allison M; Zimmerman, Kristin M; Kostas, Tia R; Pelletier, Lindsey; Hwang, Angela; Simone, Mark; Skarf, Lara M; Rudolph, James L

    2013-11-01

    Complex medication regimens are error prone and challenging for patients, which may impact medication adherence and safety. No universal method to assess the complexity of medication regimens (CMRx) exists. The authors aim to review literature for CMRx measurements to establish consistencies and, secondarily, describe CMRx impact on healthcare outcomes. A search of EMBASE and PubMed for studies analyzing at least two medications and complexity components, among those self-managing medications, was conducted. Out of 1204 abstracts, 38 studies were included in the final sample. The majority (74%) of studies used one of five validated CMRx scales; their components and scoring were compared. Universal CMRx assessment is needed to identify and reduce complex regimens, and, thus, improve safety. The authors highlight commonalities among five scales to help build consensus. Common components (i.e., regimen factors) included dosing frequency, units per dose, and non-oral routes. Elements (e.g., twice daily) of these components (e.g., dosing frequency) and scoring varied. Patient-specific factors (e.g., dexterity, cognition) were not addressed, which is a shortcoming of current scales and a challenge for future scales. As CMRx has important outcomes, notably adherence and healthcare utilization, a standardized tool has potential for far-reaching clinical, research, and patient-safety impact.

  14. Clinical safety assessment of oral higenamine supplementation in healthy, young men.

    PubMed

    Bloomer, R J; Schriefer, J M; Gunnels, T A

    2015-10-01

    Higenamine, an herbal agent also known as norcoclaurine, is thought to stimulate β-androgenic receptors and possess lipolytic activity. It is currently making its way into the dietary supplement market. To our knowledge, no studies have been conducted to determine the safety profile of oral higenamine when used alone and in conjunction with other commonly used lipolytic agents. Forty-eight men were assigned to ingest either a placebo, higenamine, caffeine, or higenamine + caffeine + yohimbe bark extract daily for a period of 8 weeks. Before and after 4 and 8 weeks of supplementation, the following variables were measured: resting respiratory rate, heart rate, blood pressure, urinalysis, complete blood count, metabolic panel, liver enzyme activity, and lipid panel. No interaction effects were noted for any variable (p > 0.05), with no changes of statistical significance occurring across time for any of the four conditions (p > 0.05). This is the first study to determine the safety profile of oral higenamine intake in human subjects. Our data indicate that 8 weeks of daily higenamine supplementation, either alone or in conjunction with caffeine and yohimbe bark extract, does not result in a statistically significant change in any of the measured outcome variables. Additional studies, inclusive of a larger sample size, are needed to extend these initial findings. © The Author(s) 2015.

  15. Global harmonization of food safety regulation from the perspective of Korea and a novel fast automatic product recall system.

    PubMed

    Sohn, Mun-Gi; Oh, Sangsuk

    2014-08-01

    Efforts have been made for global harmonization of food safety regulations among countries through international organizations such as WTO and WHO/FAO. Global harmonization of food safety regulations is becoming increasingly important for Korean consumers because more than half of food and agricultural products are imported and consumed. Through recent reorganization of the Korean government, a consolidated national food safety authority-the Ministry of Food and Drug Safety (MFDS)-has been established for more efficient food safety control and better communication with consumers. The Automatic Sales Blocking System (ASBS), which blocks the sales of the recalled food products at the point of sale, has been implemented at over 40,000 retail food stores around the nation using state-of-the art information and communication technology (ICT) for faster recall of adulterated food products, and the e-Food Safety Control System has been developed for more efficient monitoring of national food safety surveillance situations. The National Food Safety Information Service was also established for monitoring and collecting food safety information and incidents worldwide, and shares relevant information with all stakeholders. The new approaches adopted by the Korean Food Safety Authority are expected to enhance public trust with regard to food safety issues and expedite the recall process of adulterated products from the market. © 2013 Society of Chemical Industry.

  16. 77 FR 43090 - Safety and Occupational Health Study Section: Notice of Charter Renewal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-23

    ... Clifton Road NE., Mailstop E74, Atlanta, Georgia 30333, telephone 404/498-2511 or fax 404/498-2571. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal...

  17. Safety Assessment of Alkyl Esters as Used in Cosmetics.

    PubMed

    Fiume, Monice M; Heldreth, Bart A; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

    2015-09-01

    The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of 237 alkyl esters for use in cosmetics. The alkyl esters included in this assessment have a variety of reported functions in cosmetics, with skin-conditioning agent being the most common function. The Panel reviewed available animal and clinical data in making its determination of safety on these ingredients, and where there were data gaps, similarity in structure, properties, functions, and uses of these ingredients allowed for extrapolation of the available toxicological data to assess the safety of the entire group. The Panel concluded that these ingredients are safe in cosmetic formulations in the present practices of use and concentration when formulated to be nonirritating. © The Author(s) 2015.

  18. Safety Assessment of Dialkyl Sulfosuccinate Salts as Used in Cosmetics.

    PubMed

    Fiume, Monice M; Heldreth, Bart; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

    2016-11-01

    The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 8 dialkyl sulfosuccinate salts for use in cosmetics, finding that these ingredients are safe in cosmetics in the present practices of use and concentration when formulated to be nonirritating. The dialkyl sulfosuccinate salts primarily function as surfactants in cosmetics. The Panel reviewed the new and existing available animal and clinical data in making its determination of safety. The Panel found it appropriate to extrapolate the data on diethylhexyl sodium sulfosuccinate to assess the safety of the entire group because all of the diesters are of a similar alkyl chain length, all are symmetrically substituted, and all have similar functions in cosmetic formulations. © The Author(s) 2016.

  19. A correction of misinformation regarding Herbalife.

    PubMed

    Appelhans, Kristy; Najeeullah, Raushanah; Frankos, Vasilios

    2013-10-27

    The authors of the subject article by Senadhi et al have misrepresented the safety and regulatory status of Herbalife's products. While we are very concerned with the unwarranted and unfavorable publicity that the inaccuracies listed could generate for Herbalife, we would welcome any inquiries that these authors may have to better clarify our commitment to the safety and quality of our products as has been demonstrated in part by our ability to establish positive relationships with regulatory authorities worldwide through continued cooperation and compliance. This letter clarifies the misinformation presented about Herbalife in the subject article.

  20. Improving quality and safety in nursing homes and home care: the study protocol of a mixed-methods research design to implement a leadership intervention.

    PubMed

    Wiig, Siri; Ree, Eline; Johannessen, Terese; Strømme, Torunn; Storm, Marianne; Aase, Ingunn; Ullebust, Berit; Holen-Rabbersvik, Elisabeth; Hurup Thomsen, Line; Sandvik Pedersen, Anne Torhild; van de Bovenkamp, Hester; Bal, Roland; Aase, Karina

    2018-03-28

    Nursing homes and home care face challenges across different countries as people are living longer, often with chronic conditions. There is a lack of knowledge regarding implementation and impact of quality and safety interventions as most research evidence so far is generated in hospitals. Additionally, there is a lack of effective leadership tools for quality and safety improvement work in this context. The aim of the 'Improving Quality and Safety in Primary Care-Implementing a Leadership Intervention in Nursing Homes and Homecare' (SAFE-LEAD) study is to develop and evaluate a research-based leadership guide for managers to increase quality and safety competence. The project applies a mixed-methods design and explores the implications of the leadership guide on managers' and staffs' knowledge, attitudes and practices. Four nursing homes and four home care services from different Norwegian municipalities will participate in the intervention. Surveys, process evaluation (interviews, observations) and document analyses will be conducted to evaluate the implementation and impact of the leadership intervention. A comparative study of Norway and the Netherlands will establish knowledge of the context dependency of the intervention. The study is approved by the Norwegian Centre for Research Data (2017/52324 and 54855). The results will be disseminated through scientific articles, two PhD dissertations, an anthology, presentations at national and international conferences, and in social media, newsletters and in the press. The results will generate knowledge to inform leadership practices in nursing homes and home care. Moreover, the study will build new theory on leadership interventions and the role of contextual factors in nursing homes and home care. © 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 expressly granted.

  1. "You can't be cold and scientific": community views on ethical issues in intellectual disability research.

    PubMed

    McDonald, Katherine E; Schwartz, Nicole M; Gibbons, Colleen M; Olick, Robert S

    2015-04-01

    Perceptions, attitudes, and ethical concerns related to conducting research with adults with intellectual disability hinder scientific innovation to promote health. Yet we lack an understanding of community views on effective research policy and practice. To address this knowledge void, we qualitatively studied the views of adults with intellectual disability and those who provide them support regarding research participation of adults with intellectual disability. We found substantial support for their inclusion, particularly given the possibility of benefits to adults with intellectual disability, researchers, and society. We also found concerns for potential harm and differing ideas on how to promote safety. Our findings emphasize the importance of their inclusion in research, and the need for policies and practices that promote respect and safety. © The Author(s) 2015.

  2. Safety Assessment of Nitrocellulose and Collodion as Used in Cosmetics.

    PubMed

    Fiume, Monice M; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

    2016-07-01

    The Cosmetic Ingredient Review Expert Panel (the Panel) assessed the safety of nitrocellulose and collodion as used in cosmetics, concluding that these ingredients are safe in the present practices of use and concentration in cosmetic formulations. Both ingredients are used almost exclusively in nail product formulations. The maximum concentration of use of nitrocellulose in nail polish and enamels is 22%; for collodion, the maximum reported concentration of use in nail polish and enamel is 14%. The Panel reviewed available animal and clinical data in making its determination of safety. © The Author(s) 2016.

  3. Safety Evaluation Report on Tennessee Valley Authority: Browns Ferry Nuclear Performance Plan: Browns Ferry Unit 2 restart

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Not Available

    1989-04-01

    This safety evaluation report (SER) on the information submitted by the Tennessee Valley Authority (TVA) in its Nuclear Performance Plan, through Revision 2, for the Browns Ferry Nuclear Power Station and in supporting documents has been prepared by the US Nuclear Regulatory Commission staff. The plan addresses the plant-specific concerns requiring resolution before startup of Unit 2. The staff will inspect implementation of those programs. Where systems are common to Units 1 and 2 or to Units 2 and 3, the staff safety evaluations of those systems are included herein. 3 refs.

  4. Systems Engineering Technical Authority: A Path to Mission Success

    NASA Technical Reports Server (NTRS)

    Andary, James F.; So, Maria M.; Breindel, Barry

    2008-01-01

    The systems engineering of space missions to study planet Earth has been an important focus of the National Aeronautics and Space Administration (NASA) since its inception. But all space missions are becoming increasingly complex and this fact, reinforced by some major mishaps, has caused NASA to reevaluate their approach to achieving safety and mission success. A new approach ensures that there are adequate checks and balances in place to maximize the probability of safety and mission success. To this end the agency created the concept of Technical Authority which identifies a key individual accountable and responsible for the technical integrity of a flight mission as well as a project-independent reporting path. At the Goddard Space Flight Center (GSFC) this responsibility ultimately begins with the Mission Systems Engineer (MSE) for each satellite mission. This paper discusses the Technical Authority process and then describes some unique steps that are being taken at the GSFC to support these MSEs in meeting their responsibilities.

  5. NASA Engineering Excellence: A Case Study on Strengthening an Engineering Organization

    NASA Technical Reports Server (NTRS)

    Shivers, C. Herbert; Wessel, Vernon W.

    2006-01-01

    NASA implemented a system of technical authority following the Columbia Accident Investigation Board (CAE) report calling for independent technical authority to be exercised on the Space Shuttle Program activities via a virtual organization of personnel exercising specific technical authority responsibilities. After the current NASA Administrator reported for duty, and following the first of two planned "Shuttle Return to Flight" missions, the NASA Chief Engineer and the Administrator redirected the Independent Technical Authority to a program of Technical Excellence and Technical Authority exercised within the existing engineering organizations. This paper discusses the original implementation of technical authority and the transition to the new implementation of technical excellence, including specific measures aimed at improving safety of future Shuttle and space exploration flights.

  6. 29 CFR 1952.325 - Level of Federal enforcement.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... occupational safety and health issues covered by the Indiana plan. OSHA retains full authority over issues... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... safety and health standards which have been promulgated under section 6 of the Act do not apply with...

  7. 29 CFR 1952.375 - Level of Federal Enforcement.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... occupational safety and health issues covered by the Virginia plan. OSHA retains full authority over issues... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... safety and health standards which have been promulgated under section 6 of the Act do not apply with...

  8. 77 FR 65892 - Patient Safety Organizations: Voluntary Relinquishment From PDR Secure, LLC

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-31

    ... Organizations: Voluntary Relinquishment From PDR Secure, LLC AGENCY: Agency for Healthcare Research and Quality... Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information... Safety Act authorizes the listing of PSOs, which are entities or component organizations whose mission...

  9. 29 CFR 1953.2 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED... Occupational Safety and Health, or any representative authorized to perform any of the functions discussed in... modification made by a State to its approved occupational safety and health State plan which has an impact on...

  10. 29 CFR 1953.2 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED... Occupational Safety and Health, or any representative authorized to perform any of the functions discussed in... modification made by a State to its approved occupational safety and health State plan which has an impact on...

  11. Surgical team member assessment of the safety of surgery practice in 38 South Carolina hospitals.

    PubMed

    Singer, Sara J; Jiang, Wei; Huang, Lyen C; Gibbons, Lorri; Kiang, Mathew V; Edmondson, Lizabeth; Gawande, Atul A; Berry, William R

    2015-06-01

    We assessed surgical team member perceptions of multiple dimensions of safe surgical practice in 38 South Carolina hospitals participating in a statewide initiative to implement surgical safety checklists. Primary data were collected using a novel 35-item survey. We calculated the percentage of 1,852 respondents with strongly positive, positive, and neutral/negative responses about the safety of surgical practice, compared results by hospital and professional discipline, and examined how readiness, teamwork, and adherence related to staff perception of care quality. Overall, 78% of responses were positive about surgical safety at respondent's hospitals, but in each survey dimension, from 16% to 40% of responses were neutral/negative, suggesting significant opportunity to improve surgical safety. Respondents not reporting they would feel safe being treated in their operating rooms varied from 0% to 57% among hospitals. Surgeons responded more positively than nonsurgeons. Readiness, teamwork, and practice adherence related directly to staff perceptions of patient safety (p < .001). © The Author(s) 2015.

  12. Safety Assessment of Alumina and Aluminum Hydroxide as Used in Cosmetics.

    PubMed

    Becker, Lillian C; Boyer, Ivan; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

    2016-11-01

    This is a safety assessment of alumina and aluminum hydroxide as used in cosmetics. Alumina functions as an abrasive, absorbent, anticaking agent, bulking agent, and opacifying agent. Aluminum hydroxide functions as a buffering agent, corrosion inhibitor, and pH adjuster. The Food and Drug Administration (FDA) evaluated the safe use of alumina in several medical devices and aluminum hydroxide in over-the-counter drugs, which included a review of human and animal safety data. The Cosmetic Ingredient Review (CIR) Expert Panel considered the FDA evaluations as part of the basis for determining the safety of these ingredients as used in cosmetics. Alumina used in cosmetics is essentially the same as that used in medical devices. This safety assessment does not include metallic or elemental aluminum as a cosmetic ingredient. The CIR Expert Panel concluded that alumina and aluminum hydroxide are safe in the present practices of use and concentration described in this safety assessment. © The Author(s) 2016.

  13. New approach to assessment of medication safety in a community hospital.

    PubMed

    Patty, Christopher M; Miller, Sylvia

    2015-01-01

    Use of medications for hospitalized patients is nearly universal, and medication-related injuries are common. Accurate assessment of harm is foundational to development of effective hospital medication safety plans. Using methods nearly identical to those in large national studies, the author examined incidence and typology of medication-related injury. This practice innovation provided a community hospital with its first systematic assessment of medication-related injury. The information gained provided a clearer picture of injury and promoted collaboration.

  14. 16 CFR 1500.2 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Authority. 1500.2 Section 1500.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS HAZARDOUS SUBSTANCES AND ARTICLES; ADMINISTRATION AND ENFORCEMENT REGULATIONS § 1500.2 Authority. Authority under the...

  15. Identification and initial response to children's exposure to intimate partner violence: a qualitative synthesis of the perspectives of children, mothers and professionals.

    PubMed

    Lewis, Natalia V; Feder, Gene S; Howarth, Emma; Szilassy, Eszter; McTavish, Jill R; MacMillan, Harriet L; Wathen, Nadine

    2018-04-28

    To synthesise evidence on the acceptable identification and initial response to children's exposure to intimate partner violence (IPV) from the perspectives of providers and recipients of healthcare and social services. We conducted a thematic synthesis of qualitative research, appraised the included studies with the modified Critical Appraisal Skills Programme checklist and undertook a sensitivity analysis of the studies scored above 15. We searched eight electronic databases, checked references and citations and contacted authors of the included studies. We included qualitative studies with children, parents and providers of healthcare or social services about their experiences of identification or initial responses to children's exposure to IPV. Papers that have not been peer-reviewed were excluded as well as non-English papers. Searches identified 2039 records; 11 studies met inclusion criteria. Integrated perspectives of 42 children, 212 mothers and 251 professionals showed that sufficient training and support for professionals, good patient-professional relationship and supportive environment for patient/clients need to be in place before enquiry/disclosure of children's exposure to IPV should occur. Providers and recipients of care favour a phased enquiry about IPV initiated by healthcare professionals, which focuses on 'safety at home' and is integrated into the context of the consultation or visit. Participants agreed that an acceptable initial response prioritises child safety and includes emotional support, education about IPV and signposting to IPV services. Participants had conflicting perspectives on what constitutes acceptable engagement with children and management of safety. Sensitivity analysis produced similar results. Healthcare and social service professionals should receive sufficient training and ongoing individual and system-level support to provide acceptable identification of and initial response to children's exposure to IPV. Ideal identification and responses should use a phased approach to enquiry and the WHO Listen, Inquire about needs and concerns, Validate, Enhance safety and Support principles integrated into a trauma-informed and violence-informed model of care. © 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 expressly granted.

  16. Effectiveness of a school-based nutrition and food safety education program among primary and junior high school students in Chongqing, China.

    PubMed

    Zhou, Wen-Jie; Xu, Xiang-Long; Li, Ge; Sharma, Manoj; Qie, Ya-Ling; Zhao, Yong

    2016-03-01

    Health behavioral patterns, especially eating patterns, established in childhood often carry over into adulthood, and some of the unhealthy ones are later associated with adult morbidity and mortality. Recently, a few nutrition and food safety education programs have been implemented in primary and junior high schools in China. This study aims to examine the effectiveness of a school-based nutrition and food safety education program among primary and junior high school students in China. A mixed study design incorporating an intervention study and a quantitative survey was conducted for this research. With stratified cluster sampling, students from the 5(th) and 6(th) grade in one primary school and the 7(th) and 8(th) grade in one junior high school in Chongqing, China, were all selected and separated randomly into an intervention group (n = 501) and a control group (n = 522). Effectiveness evaluation investigations were performed at the initial time and nine-month follow-up (n = 472), respectively. Effectiveness of pre-/post-intervention and nine-month follow-up changes in scores of nutrition knowledge and food safety was assessed using a two-tailed t-test and analysis of variance. Nutrition knowledge scores for the intervention group were mean 9.03, SD±2.75 at the baseline, and 14.70±3.28 after intervention. There was a significant improvement (t = 29.78, p < 0.01). The nine-month follow-up knowledge scores of the intervention group were 12.35±2.89, which were lower than the immediately after the intervention group (t = 12.40, p<0.01), but higher than those of the baseline level (t = 18.04, p < 0.01). Food safety scores of the post-intervention were higher (p < 0.01) than that of the control group in both pre-intervention and nine-month follow-up. The control group had no significant change in the pre-post intervention. It is feasible and effective to improve nutrition and food safety knowledge among primary and junior high school students through school-based nutrition and food safety education programs. © The Author(s) 2014.

  17. Safety profile of a replication-deficient human adenovirus-vectored foot-and-mouth disease virus serotype A24 subunit vaccine in cattle.

    PubMed

    Barrera, J; Brake, D A; Kamicker, B J; Purcell, C; Kaptur, R; Schieber, T; Lechtenberg, K; Miller, T D; Ettyreddy, D; Brough, D E; Butman, B T; Colby, M; Neilan, J G

    2018-04-01

    The safety of a replication-deficient, human adenovirus-vectored foot-and-mouth disease virus (FMDV) serotype A24 Cruzeiro capsid-based subunit vaccine (AdtA24) was evaluated in five independent safety studies. The target animal safety studies were designed in compliance with United States (U.S.) regulatory requirements (Title 9, U.S. Code of Federal Regulation [9CFR]) and international standard guidelines (VICH Topic GL-44) for veterinary live vaccines. The first three studies were conducted in a total of 22 vaccinees and demonstrated that the AdtA24 master seed virus (MSV) was safe, did not revert to virulence and was not shed or spread from vaccinees to susceptible cattle or pigs. The fourth safety study conducted in 10 lactating cows using an AdtA24 vaccine serial showed that the vaccine was completely absent from milk. The fifth safety study was conducted under typical U.S. production field conditions in 500 healthy beef and dairy cattle using two AdtA24 vaccine serials. These results demonstrated that the vaccine was safe when used per the product label recommendations. Additional data collected during these five studies confirmed that AdtA24 vaccinees developed FMDV A24 and the HAd5 vaccine vector serum neutralization antibodies that test negative in a FMDV non-structural protein antibody test, confirming AdtA24 vaccine's capability to differentiate infected from vaccinated animals (DIVA). In conclusion, results from this comprehensive set of cattle studies demonstrated the safety of the replication-deficient AdtA24 vaccine and fulfilled safety-related requirements for U.S. regulatory requirements. © 2017 The Authors. Transboundary and Emerging Diseases Published by Blackwell Verlag GmbH.

  18. Participatory research and service-learning among farmers, health professional students, and experts: an agromedicine approach to farm safety and health.

    PubMed

    Guin, Susan M; Wheat, John R; Allinder, Russell S; Fanucchi, Gary J; Wiggins, Oscar S; Johnson, Gwendolyn J

    2012-01-01

    Agromedicine developments in Alabama rest heavily on the interest and support of the farm community. Participatory approaches have been advocated in order to impact the safety and health of farms. The University of Alabama Agromedicine Research Team, working closely with and guided by farmers, places emphasis on identifying areas of farmer concern related to agricultural health and safety and on developing jointly with the farmers plans to address their concerns. Agricultural extension agents were key to developing the trust relationships among farmers, health professionals, and extension personnel required for these successful agricultural safety and health developments. In this article the authors describe how the research team engaged farmers in participatory research to develop service learning activities for graduate students studying Agricultural Safety and Health at The University of Alabama. Accepting farmers' active role in research processes creates an environment that is favorable to change, while providing farmers reassurance that their health and safety is of utmost importance to the researchers.

  19. 75 FR 19248 - Subject: Safety Zone; Sea World Summer Nights Fireworks, Mission Bay, San Diego, CA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-14

    ...-AA00 Subject: Safety Zone; Sea World Summer Nights Fireworks, Mission Bay, San Diego, CA AGENCY: Coast... navigable waters of Mission Bay in support of the Sea World Summer Nights Fireworks. This safety zone is... through, or anchoring within this safety zone unless authorized by the Captain of the Port, or his...

  20. Measurement and monitoring of safety: impact and challenges of putting a conceptual framework into practice.

    PubMed

    Chatburn, Eleanor; Macrae, Carl; Carthey, Jane; Vincent, Charles

    2018-03-06

    The Measurement and Monitoring of Safety Framework provides a conceptual model to guide organisations in assessing safety. The Health Foundation funded a large-scale programme to assess the value and impact of applying the Framework in regional and frontline care settings. We explored the experiences and reflections of key participants in the programme. The study was conducted in the nine healthcare organisations in England and Scotland testing the Framework (three regional improvement bodies, six frontline settings). Post hoc interviews with clinical and managerial staff were analysed using template analysis. Participants reported that the Framework promoted a substantial shift in their thinking about how safety is actively managed in their environment. It provided a common language, facilitated a more inquisitive approach and encouraged a more holistic view of the components of safety. These changes in conceptual understanding, however, did not always translate into broader changes in practice, with many sites only addressing some aspects of the Framework. One of the three regions did embrace the Framework in its entirety and achieved wider impact with a range of interventions. This region had committed leaders who took time to fully understand the concepts, who maintained a flexible approach to exploring the utility of the Framework and who worked with frontline staff to translate the concepts for local settings. The Measuring and Monitoring of Safety Framework has the potential to support a broader and richer approach to organisational safety. Such a conceptually based initiative requires both committed leaders who themselves understand the concepts and more time to establish understanding and aims than might be needed in a standard improvement programme. © 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 expressly granted.

  1. Efficacy and safety of pilocarpine for radiation-induced xerostomia in patients with head and neck cancer: A systematic review and meta-analysis.

    PubMed

    Cheng, Cai-Qi; Xu, Hao; Liu, Ling; Wang, Rui-Nan; Liu, Yu-Ting; Li, Jing; Zhou, Xi-Kun

    2016-04-01

    Pilocarpine has been used widely in the treatment of dry mouth and glaucoma. In this review, the authors assessed the efficacy and safety of pilocarpine for patients with head and neck cancer who have radiation-induced xerostomia. The authors conducted a systematic search including meta-analyses and randomized controlled trials in the following databases: MEDLINE, Embase, Cochrane Library, and Science Citation Index Expanded. The primary outcome was the severity of xerostomia (measured using visual analog scale [VAS] scores). Adverse events were other outcomes of interest. The authors performed meta-analyses where appropriate. The authors used the Cochrane Collaboration's tool for assessing risk of bias to assess the quality of the study. The authors identified 6 studies (including 752 patients in total). The results of a meta-analysis of 3 articles showed that pilocarpine was associated with a 12-point increase in VAS score (mean difference, 12.00; 95% confidence interval [CI], 1.93-22.08; P = .02) and higher rates of adverse events compared with placebo in terms of sweating (odds ratio [OR], 3.71; 95% CI, 2.34-5.86; P < .00001). There were no differences in rhinitis (OR, 1.21; 95% CI, 0.68-2.16; P = .52) and nausea (OR, 1.44; 95% CI, 0.83-2.49; P = .19). On the basis of the best available evidence, the results of this meta-analysis provide evidence that pilocarpine offers statistically significant clinical benefits for the symptomatic treatment of radiation-induced xerostomia in patients with head and neck cancer. However, the authors of this systematic review found the best available evidence in the meta-analysis in 3 studies, 1 of which showed no effect. The authors of this systematic review suggest that these patients take 5 milligrams of pilocarpine 3 times daily, and that there is need for further study. Copyright © 2016 American Dental Association. Published by Elsevier Inc. All rights reserved.

  2. Imbuing medical professionalism in relation to safety: a study protocol for a mixed-methods intervention focused on trialling an embedded learning approach that centres on the use of a custom designed board game.

    PubMed

    Ward, Marie; McAuliffe, Eilish; Ní Shé, Éidín; Duffy, Ann; Geary, Una; Cunningham, Una; Holland, Catherine; McDonald, Nick; Egan, Karen; Korpos, Christian

    2017-07-17

    Healthcare organisations have a responsibility for ensuring that the governance of workplace settings creates a culture that supports good professional practice. Encouraging such a culture needs to start from an understanding of the factors that make it difficult for health professionals to raise issues of concern in relation to patient safety. The focus of this study is to determine whether a customised education intervention, developed as part of the study, with interns and senior house officers (SHOs) can imbue a culture of medical professionalism in relation to patient safety and support junior doctors to raise issues of concern, while shaping a culture of responsiveness and learning. We will use quantitative and qualitative methods to collect data. The sample size will be approximately 200 interns and SHOs across the two hospital sites. Two surveys will be included with one measuring leadership inclusiveness and psychological safety and a second capturing information on safety concerns that participants may have witnessed in their places of work. The PlayDecide embedded learning intervention will be developed with key stakeholders. This will be trialled in the middle stage of data collection for both interns and SHOs. A detailed content analysis will be conducted on the surveys to assess any changes in reporting following the PlayDecide intervention. This will be compared with the incident reporting levels and the results of the preintervention and postintervention leadership inclusiveness and psychological safety survey. Statistical analysis will be conducted using SPSS. Differences will be considered statistically significant at p<0.05. Semistructured interviews using a critical incident technique will be used for the ongoing analysis and evaluation of the project. These will be transcribed, de-identified and coded into themes. The study has been granted ethics approval from University College Dublin (Ref. LS-15-19-Ward-McAuliffe: Imbuing Medical Professionalism in Relation to Safety). The study results will be disseminated through peer-reviewed publications. © 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.

  3. 29 CFR 1952.95 - Level of Federal enforcement.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... safety and health issues covered by the South Carolina plan. OSHA retains full authority over issues... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... Carolina plan under section 18(e) of the Act, effective December 15, 1987, occupational safety and health...

  4. 10 CFR 820.62 - Criteria.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... granting an exemption to a DOE Nuclear Safety Requirement are determinations that the exemption: (a) Would be authorized by law; (b) Would not present an undue risk to public health and safety, the... similarly situated; or (4) The exemption would result in benefit to human health and safety that compensates...

  5. 10 CFR 820.62 - Criteria.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... granting an exemption to a DOE Nuclear Safety Requirement are determinations that the exemption: (a) Would be authorized by law; (b) Would not present an undue risk to public health and safety, the... similarly situated; or (4) The exemption would result in benefit to human health and safety that compensates...

  6. 10 CFR 820.62 - Criteria.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... granting an exemption to a DOE Nuclear Safety Requirement are determinations that the exemption: (a) Would be authorized by law; (b) Would not present an undue risk to public health and safety, the... similarly situated; or (4) The exemption would result in benefit to human health and safety that compensates...

  7. 10 CFR 820.62 - Criteria.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... granting an exemption to a DOE Nuclear Safety Requirement are determinations that the exemption: (a) Would be authorized by law; (b) Would not present an undue risk to public health and safety, the... similarly situated; or (4) The exemption would result in benefit to human health and safety that compensates...

  8. 10 CFR 820.62 - Criteria.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... granting an exemption to a DOE Nuclear Safety Requirement are determinations that the exemption: (a) Would be authorized by law; (b) Would not present an undue risk to public health and safety, the... similarly situated; or (4) The exemption would result in benefit to human health and safety that compensates...

  9. Where the Safety Rubber Meets the Shop Floor: A Confirmatory Model of Management Influence on Workplace Safety.

    DOT National Transportation Integrated Search

    1997-03-01

    The role of management in establishing a safe work environment remains a topic that receives less attention in the literature than it deserves. Many authors have focused on safety programs and associated indications of program effects. Prescriptive a...

  10. 29 CFR 1975.2 - Basis of authority.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) COVERAGE OF EMPLOYERS UNDER THE WILLIAMS-STEIGER OCCUPATIONAL SAFETY AND HEALTH ACT OF 1970 § 1975.2 Basis... Occupational Safety and Health Act of 1970, is derived mainly from the Commerce Clause of the Constitution...

  11. 78 FR 56611 - Safety Zone, Shallowbag Bay; Manteo, NC; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

    ... Part 165 Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security... as follows: PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 0 1. The authority citation... representative, unless the Captain of the Port previously announced via Marine Safety Radio Broadcast on VHF...

  12. 29 CFR 1952.165 - Level of Federal enforcement.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... occupational safety and health issues covered by the Iowa plan. OSHA retains full authority over issues which... approval of the Iowa plan under section 18(e) of the Act, effective July 2, 1985, occupational safety and...

  13. 29 CFR 1952.165 - Level of Federal enforcement.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... occupational safety and health issues covered by the Iowa plan. OSHA retains full authority over issues which... approval of the Iowa plan under section 18(e) of the Act, effective July 2, 1985, occupational safety and...

  14. 29 CFR 1952.174 - Completion of developmental steps and certification.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... approved: Authority to grant or deny temporary variances rests with the Division of Industrial Safety, and... Board hears appeals from the Division of Industrial Safety's decisions on temporary variances. (b) In....174 Section 1952.174 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH...

  15. 29 CFR 1952.174 - Completion of developmental steps and certification.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... approved: Authority to grant or deny temporary variances rests with the Division of Industrial Safety, and... Board hears appeals from the Division of Industrial Safety's decisions on temporary variances. (b) In....174 Section 1952.174 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH...

  16. 29 CFR 1952.174 - Completion of developmental steps and certification.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... approved: Authority to grant or deny temporary variances rests with the Division of Industrial Safety, and... Board hears appeals from the Division of Industrial Safety's decisions on temporary variances. (b) In....174 Section 1952.174 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH...

  17. 29 CFR 1952.174 - Completion of developmental steps and certification.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... approved: Authority to grant or deny temporary variances rests with the Division of Industrial Safety, and... Board hears appeals from the Division of Industrial Safety's decisions on temporary variances. (b) In....174 Section 1952.174 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH...

  18. Impact of individual resilience and safety climate on safety performance and psychological stress of construction workers: A case study of the Ontario construction industry.

    PubMed

    Chen, Yuting; McCabe, Brenda; Hyatt, Douglas

    2017-06-01

    The construction industry has hit a plateau in terms of safety performance. Safety climate is regarded as a leading indicator of safety performance; however, relatively little safety climate research has been done in the Canadian construction industry. Safety climate may be geographically sensitive, thus it is necessary to examine how the construct of safety climate is defined and used to improve safety performance in different regions. On the other hand, more and more attention has been paid to job related stress in the construction industry. Previous research proposed that individual resilience may be associated with a better safety performance and may help employees manage stress. Unfortunately, few empirical research studies have examined this hypothesis. This paper aims to examine the role of safety climate and individual resilience in safety performance and job stress in the Canadian construction industry. The research was based on 837 surveys collected in Ontario between June 2015 and June 2016. Structural equation modeling (SEM) techniques were used to explore the impact of individual resilience and safety climate on physical safety outcomes and on psychological stress among construction workers. The results show that safety climate not only affected construction workers' safety performance but also indirectly affected their psychological stress. In addition, it was found that individual resilience had a direct negative impact on psychological stress but had no impact on physical safety outcomes. These findings highlight the roles of both organizational and individual factors in individual safety performance and in psychological well-being. Construction organizations need to not only monitor employees' safety performance, but also to assess their employees' psychological well-being. Promoting a positive safety climate together with developing training programs focusing on improving employees' psychological health - especially post-trauma psychological health - can improve the safety performance of an organization. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  19. Authors' financial relationships with the food and beverage industry and their published positions on the fat substitute olestra.

    PubMed

    Levine, Jane; Gussow, Joan Dye; Hastings, Diane; Eccher, Amy

    2003-04-01

    This study examined the association between authors' published positions on the safety and efficacy in assisting with weight loss of the Procter & Gamble (P&G) fat substitute olestra and their financial relationships with the food and beverage industry. Journal articles about olestra, and their authors, were classified as supportive, critical, or neutral with respect to its use. Authors not known to have industry affiliations were surveyed about their financial relationships. Supportive authors were significantly more likely than critical or neutral authors to have financial relationships with P&G (80% vs 11% and 21%, respectively; P <.0001). All authors disclosing an affiliation with P&G were supportive. Because authors' published opinions were associated with their financial relationships, obtaining noncommercial funding may be more essential to maintaining objectivity than disclosing personal financial interests.

  20. 78 FR 55064 - First Responder Network Authority Board Special Review Committee Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-09

    ... Network Authority Board Special Review Committee Meeting AGENCY: National Telecommunications and... Responder Network Authority Special Review Committee. SUMMARY: The First Responder Network Authority (First... nationwide, interoperable public safety broadband network. The FirstNet Board is responsible for making...

  1. 78 FR 72666 - First Responder Network Authority Board Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-03

    ... Network Authority Board Meeting AGENCY: National Telecommunications and Information Administration, U.S... Authority. SUMMARY: The Board of the First Responder Network Authority (FirstNet) will convene open public... single nationwide, interoperable public safety broadband network. The FirstNet Board is responsible for...

  2. The Relationship Between the Learning and Patient Safety Climates of Clinical Departments and Residents' Patient Safety Behaviors.

    PubMed

    Silkens, Milou E W M; Arah, Onyebuchi A; Wagner, Cordula; Scherpbier, Albert J J A; Heineman, Maas Jan; Lombarts, Kiki M J M H

    2018-05-15

    Improving residents' patient safety behavior should be a priority in graduate medical education to ensure the safety of current and future patients. Supportive learning and patient safety climates may foster this behavior. This study examined the extent to which residents' self-reported patient safety behavior can be explained by the learning climate and patient safety climate of their clinical departments. The authors collected learning climate data from clinical departments in the Netherlands that used the web-based Dutch Residency Educational Climate Test between September 2015 and October 2016. They also gathered data on those departments' patient safety climate and on residents' self-reported patient safety behavior. They used generalized linear mixed models and multivariate general linear models to test for associations in the data. In total, 1,006 residents evaluated 143 departments in 31 teaching hospitals. Departments' patient safety climate was associated with residents' overall self-reported patient safety behavior (regression coefficient (b) = 0.33; 95% confidence interval (CI) = 0.14 - 0.52). Departments' learning climate was not associated with residents' patient safety behavior (b = 0.01; 95% CI = -0.17 - 0.19), although it was with their patient safety climate (b = 0.73; 95% CI = 0.69 - 0.77). Departments should focus on establishing a supportive patient safety climate to improve residents' patient safety behavior. Building a supportive learning climate might help to improve the patient safety climate and, in turn, residents' patient safety behavior.

  3. Akkermansia muciniphila: a novel functional microbe with probiotic properties.

    PubMed

    Gómez-Gallego, C; Pohl, S; Salminen, S; De Vos, W M; Kneifel, W

    2016-09-01

    Akkermansia muciniphila is an intestinal anaerobe which has been proposed as a new functional microbe with probiotic properties. However, the species is not included in the European Union qualified presumption of safety (QPS) list and has not yet been assessed. Moreover, products containing A. muciniphila are not on the market and are thus controlled by the Novel Foods Regulation, which requires extensive safety assessment. This review addresses the safety aspects of the use of A. muciniphila based on published information on its functions in humans and predictions based on its activity in model animals. Further, comprehensive studies related to A. muciniphila and its safety properties have gradually appeared and are summarised here. Many of the criteria required for novel food safety assessment in Europe can thus be fulfilled. However, studies focusing on the toxicological properties of A. muciniphila, including long-term and reproduction studies, have not so far been reported and are discussed in the light of the observation that most, if not all, healthy subjects are known to carry this intestinal anaerobe. As this also applies to other beneficial bacteria found in the human intestinal tract, the A. muciniphila case can be seen as a model for the comprehensive safety evaluations required by the European authorities.

  4. The moderating role of safety-specific trust on the relation between safety-specific leadership and safety citizenship behaviors.

    PubMed

    Conchie, Stacey M; Donald, Ian J

    2009-04-01

    The authors examined whether safety-specific trust moderates or mediates the relationship between safety-specific transformational leadership and subordinates' safety citizenship behavior. Data from 139 subordinate-supervisor dyads were collected from the United Kingdom construction industry and analyzed using hierarchical regression models. Results showed that safety-specific trust moderated rather than mediated the effects of safety-specific transformational leaders on subordinates' behavior. Specifically, in conditions of high and moderate safety-specific trust, leaders had a significant effect on subordinates' safety citizenship behavior. However, in conditions of low safety-specific trust, leaders did not significantly influence subordinates' safety citizenship behavior. The implications of these findings for general safety theory and practice are discussed.

  5. Is there a relationship between high-quality performance in major teaching hospitals and residents' knowledge of quality and patient safety?

    PubMed

    Pingleton, Susan K; Horak, Bernard J; Davis, David A; Goldmann, Donald A; Keroack, Mark A; Dickler, Robert M

    2009-11-01

    The relationship of the quality of teaching hospitals' clinical performance to resident education in quality and patient safety is unclear. The authors studied residents' knowledge of these areas in major teaching hospitals with higher- and lower-quality performance rankings. They assessed the presence of formal and informal quality curricula to determine whether programmatic differences exist. The authors used qualitative research methodology with purposeful sampling. They gathered data from individual structured interviews with residents and key educational and quality leaders in six medical schools and teaching hospitals, which represented a range of quality performance rankings, geographic regions, and public or private status. No relationship emerged between a hospital's quality status, residents' curriculum, and the residents' understanding of quality. Residents' definitions of quality and safety and their knowledge of the practice-based learning and systems-based practice competencies were indistinguishable between hospitals. Residents in all programs had extensive patient safety knowledge acquired through an informal curriculum in the hospital setting. A formal curriculum existed in only two programs, both of them ambulatory settings. Residents' learning about quality and patient safety is extensive, largely through a positive informal curriculum in the teaching hospital and, less frequently, via a formal curriculum. No relationship was found between the quality performance of the teaching hospital and the residents' curriculum or understanding of quality or safety. Residents seem to learn through an informal curriculum provided by hospital initiatives and resources, and thus these data suggest the importance of major teaching hospitals in quality education.

  6. Safety evaluation of HOWARU® Restore (Lactobacillus acidophilus NCFM, Lactobacillus paracasei Lpc-37, Bifidobacterium animalis subsp. lactis Bl-04 and B. lactis Bi-07) for antibiotic resistance, genomic risk factors, and acute toxicity.

    PubMed

    Morovic, Wesley; Roper, Jason M; Smith, Amy B; Mukerji, Pushkor; Stahl, Buffy; Rae, Jessica Caverly; Ouwehand, Arthur C

    2017-12-01

    Although probiotic lactobacilli and bifidobacteria are generally considered safe by various regulatory agencies, safety properties, such as absence of transferable antibiotic resistance, must still be determined for each strain prior to market introduction as a probiotic. Safety requirements for probiotics vary regionally and evaluation methods are not standardized, therefore methodologies are often adopted from food ingredients or chemicals to assess microbial safety. Four individual probiotic strains, Lactobacillus acidophilus NCFM ® , Lactobacillus paracasei Lpc-37 ® , Bifidobacterium animalis subsp. lactis strains Bl-04 ® , and Bi-07 ® , and their combination (HOWARU ® Restore) were examined for antibiotic resistance by broth microdilution culture, toxin genes by PCR and genome mining, and acute oral toxicity in rats. Only B. lactis Bl-04 exhibited antibiotic resistance above a regulated threshold due to a tetW gene previously demonstrated to be non-transferable. Genomic mining did not reveal any bacterial toxin genes known to harm mammalian hosts in any of the strains. The rodent studies did not indicate any evidence of acute toxicity following a dose of 1.7-4.1 × 10 12  CFU/kg body weight. Considering a 100-fold safety margin, this corresponds to 1.2-2.8 × 10 12  CFU for a 70 kg human. Our findings demonstrate a comprehensive approach of in vitro, in silico, and in vivo safety testing for probiotics. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.

  7. Safety climate and attitude toward medication error reporting after hospital accreditation in South Korea.

    PubMed

    Lee, Eunjoo

    2016-09-01

    This study compared registered nurses' perceptions of safety climate and attitude toward medication error reporting before and after completing a hospital accreditation program. Medication errors are the most prevalent adverse events threatening patient safety; reducing underreporting of medication errors significantly improves patient safety. Safety climate in hospitals may affect medication error reporting. This study employed a longitudinal, descriptive design. Data were collected using questionnaires. A tertiary acute hospital in South Korea undergoing a hospital accreditation program. Nurses, pre- and post-accreditation (217 and 373); response rate: 58% and 87%, respectively. Hospital accreditation program. Perceived safety climate and attitude toward medication error reporting. The level of safety climate and attitude toward medication error reporting increased significantly following accreditation; however, measures of institutional leadership and management did not improve significantly. Participants' perception of safety climate was positively correlated with their attitude toward medication error reporting; this correlation strengthened following completion of the program. Improving hospitals' safety climate increased nurses' medication error reporting; interventions that help hospital administration and managers to provide more supportive leadership may facilitate safety climate improvement. Hospitals and their units should develop more friendly and intimate working environments that remove nurses' fear of penalties. Administration and managers should support nurses who report their own errors. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  8. Safety Assessment of Panax spp Root-Derived Ingredients as Used in Cosmetics.

    PubMed

    Becker, Lillian C; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

    2015-01-01

    The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of 13 Panax spp root-derived ingredients as used in cosmetics. Panax "spp" indicates that multiple species within the genus are used in cosmetics, but not all species within that genus. Four species are being considered in this safety assessment. These ingredients function mostly as skin-conditioning agents-miscellaneous, fragrance ingredients, skin-conditioning agents-humectant, skin-conditioning agents-emollient, and cosmetic astringents. The Panel reviewed available data related to these ingredients and addressed the issue of pulegone, a constituent of these ingredients and other ingredients, such as peppermint oil. The Panel concluded that these Panax spp root-derived ingredients are safe in the practices of use and concentration as given in this safety assessment. © The Author(s) 2015.

  9. Efficacy and safety of renal denervation for Chinese patients with resistant hypertension using a microirrigated catheter: study design and protocol for a prospective multicentre randomised controlled trial.

    PubMed

    Liu, Zongjun; Shen, Li; Huang, Weijian; Zhao, Xianxian; Fang, Weiyi; Wang, Changqian; Yin, Zhaofang; Wang, Jianan; Fu, Guosheng; Liu, Xuebo; Jiang, Jianjun; Zhang, Zhihui; Li, Jingbo; Lu, Yingmin; Ge, Junbo

    2017-09-01

    Available data show that approximately 8%-18% of patients with primary hypertension will develop resistant hypertension. In recent years, catheter-based renal denervation (RDN) has emerged as a potential treatment option for resistant hypertension. A number of observational studies and randomised controlled trials among non-Chinese patients have demonstrated its potential safety and efficacy. This is a multicentre, randomised, open-label, parallel-group, active controlled trial that will investigate the efficacy and safety of a 5F saline-irrigated radiofrequency ablation (RFA) used for RDN in the treatment of Chinese patients with resistant hypertension. A total of 254 patients who have failed pharmacological therapy will be enrolled. Eligible subjects will be randomised in a 1:1 ratio to undergo RDN using the RFA plus antihypertensive medication or to receive treatment with antihypertensive medication alone. The primary outcome measure is the change in 24 hours average ambulatory systolic blood pressure from baseline to 3 months, comparing the RDN-plus-medication group with the medication-alone group. Important secondary endpoints include the change in office blood pressure from baseline to 6 months after randomisation. Safety endpoints such as changes in renal function will also be evaluated. The full analysis set, according to the intent-to-treat principle, will be established as the primary analysis population. All participants will provide informed consent; the study protocol has been approved by the Independent Ethics Committee for each site. This study is designed to investigate the efficacy and safety of RDN using a 5F saline microirrigated RFA. Findings will be shared with participating hospitals, policymakers and the academic community to promote the clinical management of resistant hypertension in China. ClinicalTrials.gov ID: NCT02900729; pre-results. © 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.

  10. Researching safety culture: deliberative dialogue with a restorative lens.

    PubMed

    Lorenzini, Elisiane; Oelke, Nelly D; Marck, Patricia Beryl; Dall'agnol, Clarice Maria

    2017-10-01

    Safety culture is a key component of patient safety. Many patient safety strategies in health care have been adapted from high-reliability organizations (HRO) such as aviation. However, to date, attempts to transform the cultures of health care settings through HRO approaches have had mixed results. We propose a methodological approach for safety culture research, which integrates the theory and practice of restoration science with the principles and methods of deliberative dialogue to support active engagement in critical reflection and collective debate. Our aim is to describe how these two innovative approaches in health services research can be used together to provide a comprehensive effective method to study and implement change in safety culture. Restorative research in health care integrates socio-ecological theory of complex adaptive systems concepts with collaborative, place-sensitive study of local practice contexts. Deliberative dialogue brings together all stakeholders to collectively develop solutions on an issue to facilitate change. Together these approaches can be used to actively engage people in the study of safety culture to gain a better understanding of its elements. More importantly, we argue that the synergistic use of these approaches offers enhanced potential to move health care professionals towards actionable strategies to improve patient safety within today's complex health care systems. © The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  11. 77 FR 6143 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-07

    ... Radiation Safety Officer (RSO), authorized medical physicist (AMP), authorized nuclear pharmacist (ANP), or...''; (3) NRC Form 313A (ANP), ``Authorized Nuclear Pharmacist Training and Experience and Preceptor...

  12. 75 FR 45697 - Safety Advisory Notice: Personal Electronic Device Related Distractions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... the Federal safety authority for the transportation of hazardous materials by air, rail, highway, and... transportation of hazardous materials. In light of PHMSA's vital safety mission, we issue this advisory bulletin... hazardous materials transportation. Issued in Washington, DC, on July 27, 2010. Magdy El-Sibaie, Associate...

  13. 78 FR 76656 - Agency Information Collection Activities; Submission for OMB Review; Comment Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-18

    ... to provide the OSHA, National Institute for Occupational Safety and Health, affected workers, and... Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information... Occupational Safety and Health Act authorizes this information collection. See 29 U.S.C. 651, 655, and 657...

  14. 10 CFR 35.415 - Safety precautions.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Safety precautions. 35.415 Section 35.415 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Manual Brachytherapy § 35.415 Safety precautions. (a... his or her designee, and an authorized user as soon as possible if the patient or human research...

  15. 10 CFR 35.410 - Safety instruction.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Safety instruction. 35.410 Section 35.410 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Manual Brachytherapy § 35.410 Safety instruction. In... designee, and an authorized user if the patient or the human research subject has a medical emergency or...

  16. 78 FR 77496 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Student...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-23

    ... (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information... maintain PRA authorization for the Student Data Form, Form OSHA-182. The Occupational Safety and Health Act... education in occupational safety and health for Federal and State compliance officers, OSHA professionals...

  17. 9 CFR 390.9 - Communications with State and other Federal government agencies.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Federal government agencies. 390.9 Section 390.9 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE ADMINISTRATIVE PROVISIONS FREEDOM OF...) The Administrator of the Food Safety and Inspection Service (FSIS), or designee, may authorize the...

  18. 78 FR 38771 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-27

    ... information that raises significant identity theft, personal safety, or privacy concerns that are not... raises personal safety or privacy concerns is released to the public when considering whether to release... customer information or information that raises identity theft, personal safety or privacy concerns that do...

  19. Highway Safety Program Manual: Volume 2: Motor Vehicle Registration.

    ERIC Educational Resources Information Center

    National Highway Traffic Safety Administration (DOT), Washington, DC.

    Volume 2 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) describes the purposes and specific objectives of motor vehicle registration. Federal authority for vehicle registration and general policies regarding vehicle registration systems are outlined.…

  20. 75 FR 54351 - Statement of Organization, Functions, and Delegations of Authority

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-07

    ... helping staff create a safe, healthful workplace environment, by assisting in the prevention of work... Health and Safety (CAJP), and insert the following: Office of Safety, Health, and Environment (CAJP). The mission of the Office of Safety, Health, and Environment (OSHE) of the Centers for Disease Control and...

  1. 78 FR 67445 - Pilot Program on NAFTA Trucking Provisions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-12

    ... comment on data and information concerning the Pre-Authorization Safety Audit (PASA) for Road Machinery Co..., or for the purpose of avoiding or hiding previous non-compliance or safety problems. Road Machinery... corrective action, the safety suspension was not enforced during roadside inspections. Road Machinery Co SA...

  2. Behavior-Based Safety and Occupational Risk Management

    ERIC Educational Resources Information Center

    Geller, E. Scott

    2005-01-01

    The behavior-based approach to managing occupational risk and preventing workplace injuries is reviewed. Unlike the typical top-down control approach to industrial safety, behavior-based safety (BBS) provides tools and procedures workers can use to take personal control of occupational risks. Strategies the author and his colleagues have been…

  3. 76 FR 78157 - Safety Zone; Eisenhower Expressway Bridge Rehabilitation Project; Chicago River South Branch...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-16

    ...-AA00 Safety Zone; Eisenhower Expressway Bridge Rehabilitation Project; Chicago River South Branch... the Eisenhower Expressway Bridge. This temporary safety zone is necessary to protect the surrounding... Bridge. Entry into this zone is prohibited unless specifically authorized by the Captain of the Port...

  4. Occupational Safety and Health Systems: A Three-Country Comparison.

    ERIC Educational Resources Information Center

    Singleton, W. T.

    1983-01-01

    This article compares the occupational safety and health systems of Switzerland, the United Kingdom, and the United States, looking at the origins of their legislation and its effects on occupational safety and health, with a view to determining what lessons may emerge, particularly for developing countries. (Author/SSH)

  5. Translating Health Services Research into Practice in the Safety Net.

    PubMed

    Moore, Susan L; Fischer, Ilana; Havranek, Edward P

    2016-02-01

    To summarize research relating to health services research translation in the safety net through analysis of the literature and case study of a safety net system. Literature review and key informant interviews at an integrated safety net hospital. This paper describes the results of a comprehensive literature review of translational science literature as applied to health care paired with qualitative analysis of five key informant interviews conducted with senior-level management at Denver Health and Hospital Authority. Results from the literature suggest that implementing innovation may be more difficult in the safety net due to multiple factors, including financial and organizational constraints. Results from key informant interviews confirmed the reality of financial barriers to innovation implementation but also implied that factors, including institutional respect for data, organizational attitudes, and leadership support, could compensate for disadvantages. Translating research into practice is of critical importance to safety net providers, which are under increased pressure to improve patient care and satisfaction. Results suggest that translational research done in the safety net can better illuminate the special challenges of this setting; more such research is needed. © Health Research and Educational Trust.

  6. The Triangle Model for evaluating the effect of health information technology on healthcare quality and safety

    PubMed Central

    Kern, Lisa M; Abramson, Erika; Kaushal, Rainu

    2011-01-01

    With the proliferation of relatively mature health information technology (IT) systems with large numbers of users, it becomes increasingly important to evaluate the effect of these systems on the quality and safety of healthcare. Previous research on the effectiveness of health IT has had mixed results, which may be in part attributable to the evaluation frameworks used. The authors propose a model for evaluation, the Triangle Model, developed for designing studies of quality and safety outcomes of health IT. This model identifies structure-level predictors, including characteristics of: (1) the technology itself; (2) the provider using the technology; (3) the organizational setting; and (4) the patient population. In addition, the model outlines process predictors, including (1) usage of the technology, (2) organizational support for and customization of the technology, and (3) organizational policies and procedures about quality and safety. The Triangle Model specifies the variables to be measured, but is flexible enough to accommodate both qualitative and quantitative approaches to capturing them. The authors illustrate this model, which integrates perspectives from both health services research and biomedical informatics, with examples from evaluations of electronic prescribing, but it is also applicable to a variety of types of health IT systems. PMID:21857023

  7. Biological fate of low-calorie sweeteners.

    PubMed

    Magnuson, Bernadene A; Carakostas, Michael C; Moore, Nadia H; Poulos, Sylvia P; Renwick, Andrew G

    2016-11-01

    With continued efforts to find solutions to rising rates of obesity and diabetes, there is increased interest in the potential health benefits of the use of low- and no-calorie sweeteners (LNCSs). Concerns about safety often deter the use of LNCSs as a tool in helping control caloric intake, even though the safety of LNCS use has been affirmed by regulatory agencies worldwide. In many cases, an understanding of the biological fate of the different LNSCs can help health professionals to address safety concerns. The objectives of this review are to compare the similarities and differences in the chemistry, regulatory status, and biological fate (including absorption, distribution, metabolism, and excretion) of the commonly used LNCSs: acesulfame potassium, aspartame, saccharin, stevia leaf extract (steviol glycoside), and sucralose. Understanding the biological fate of the different LNCSs is helpful in evaluating whether reports of biological effects in animal studies or in humans are indicative of possible safety concerns. Illustrations of the usefulness of this information to address questions about LNCSs include discussion of systemic exposure to LNCSs, the use of sweetener combinations, and the potential for effects of LNCSs on the gut microflora. © The Author(s) 2016. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  8. Reported fire safety and first-aid amenities in Airbnb venues in 16 American cities.

    PubMed

    Kennedy, Hudson R; Jones, Vanya C; Gielen, Andrea

    2018-05-07

    Airbnb helps hosts rent all or part of their home to guests as an alternative to traditional hospitality settings. Airbnb venues are not uniformly regulated across the USA. This study quantified the reported prevalence of fire safety and first-aid amenities in Airbnb venues in the USA. The sample includes 120 691 venues in 16 US cities. Proportions of host-reported smoke and carbon monoxide (CO) detectors, fire extinguishers and first-aid kits were calculated. The proportion of venues that reportedly contained amenities are as follows: smoke detectors 80% (n=96 087), CO detectors 57.5% (n=69 346), fire extinguishers 42% (n=50 884) and first-aid kits 36% (n=43 497). Among this sample of Airbnb venues, safety deficiencies were noted. While most venues had smoke alarms, approximately 1/2 had CO alarms and less than 1/2 reported having a fire extinguishers or first-aid kits. Local and state governments or Airbnb must implement regulations compliant with current National Fire Protection Association fire safety standards. © 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 expressly granted.

  9. An empowerment model of workplace support following disclosure, for people with MS.

    PubMed

    Kirk-Brown, A K; Van Dijk, P A

    2014-10-01

    Vocational interventions aimed at increasing job retention for people with multiple sclerosis (MS) are reliant upon a partnership with a supportive work environment. A better understanding of the types of psychosocial support that are most conducive to retaining employees' sense of work-efficacy will enhance the success of interventions aimed at reducing workplace barriers to job maintenance. The objective of this study is to identify the types of psychosocial support that people with MS require post-disclosure, in order to maintain their employment status. In particular, we examined the roles of psychological safety and work-efficacy. We interviewed 40 employees with MS either individually (n = 25) or within three focus groups (n = 15). These interviews were audio-taped and the content analysed, using an inductive thematic approach. Themes to emerge in organisational responses to disclosure were: a focus on ability (leading to enhanced perceptions of psychological safety and higher work-efficacy) and on disability (leading to diminished psychological safety and reduced perceptions of work-efficacy). Organisational responses to disclosure demonstrating trust and inclusive decision making, and focussing on employee abilities, enhance perceptions of psychological safety at work. This increases the likelihood that employees with MS will retain their sense of work-efficacy and reduce their intentions to leave. © The Author(s) 2014.

  10. Environmental Health and Safety Hazards Experienced by Home Health Care Providers: A Room-by-Room Analysis.

    PubMed

    Polivka, Barbara J; Wills, Celia E; Darragh, Amy; Lavender, Steven; Sommerich, Carolyn; Stredney, Donald

    2015-11-01

    The number of personnel providing in-home health care services is increasing substantially. The unique configuration of environmental hazards in individual client homes has a significant impact on the safety and health of home health care providers (HHPs). This mixed-methods study used data from a standardized questionnaire, focus groups, and individual interviews to explore environmental health and safety hazards encountered by HHPs in client homes. The participant sample (N = 68) included nurses, aides, therapists, and owners/managers from a variety of geographic locations. The most often-reported hazards were trip/slip/lift hazards, biohazards, and hazards from poor air quality, allergens, pests and rodents, and fire and burns. Frequency of identified key hazards varied by room, that is, kitchen (e.g., throw rugs, water on floor), bathroom (e.g., tight spaces for client handling), bedroom (e.g., bed too low), living room (e.g., animal waste), and hallway (e.g., clutter). Findings indicate the need for broader training to enable HHPs to identify and address hazards they encounter in client homes. © 2015 The Author(s).

  11. Role of trade unions in workplace health promotion.

    PubMed

    Johansson, Mauri; Partanen, Timo

    2002-01-01

    Since the 19th century, workers have organized in trade unions and parties to strengthen their efforts at improving workplace health and safety, job conditions, working hours, wages, job contracts, and social security. Cooperation between workers and their organizations and professionals has been instrumental in improving regulation and legislation affecting workers' health. The authors give examples of participatory research in occupational health in Denmark and Finland. The social context of workplace health promotion, particularly the role of unions and workers' safety representatives, is described in an international feasibility study. Health promotion is rife with fundamental political, socioeconomic, philosophical, ethical, gender- and ethnicity-related, psychological, and biological problems. Analysis of power and context is crucial, focusing on political systems nationally, regionally, and globally. The authors advocate defending and supporting workers and their trade unions and strengthening their influence on workplace health promotion. In the face of rapid capitalist globalization, unions represent a barricade in defense of workers' health and safety. Health promoters and related professionals are encouraged to support trade unions in their efforts to promote health for workers and other less privileged groups.

  12. Comparison of AIHA ISO 9001-based occupational health and safety management system guidance document with a manufacturer's occupational health and safety assessment instrument.

    PubMed

    Dyjack, D T; Levine, S P; Holtshouser, J L; Schork, M A

    1998-06-01

    Numerous manufacturing and service organizations have integrated or are considering integration of their respective occupational health and safety management and audit systems into the International Organization for Standardization-based (ISO) audit-driven Quality Management Systems (ISO 9000) or Environmental Management Systems (ISO 14000) models. Companies considering one of these options will likely need to identify and evaluate several key factors before embarking on such efforts. The purpose of this article is to identify and address the key factors through a case study approach. Qualitative and quantitative comparisons of the key features of the American Industrial Hygiene Association ISO-9001 harmonized Occupational Health and Safety Management System with The Goodyear Tire & Rubber Co. management and audit system were conducted. The comparisons showed that the two management systems and their respective audit protocols, although structured differently, were not substantially statistically dissimilar in content. The authors recommend that future studies continue to evaluate the advantages and disadvantages of various audit protocols. Ideally, these studies would identify those audit outcome measures that can be reliably correlated with health and safety performance.

  13. A multilevel model of patient safety culture: cross-level relationship between organizational culture and patient safety behavior in Taiwan's hospitals.

    PubMed

    Chen, I-Chi; Ng, Hui-Fuang; Li, Hung-Hui

    2012-01-01

    As health-care organizations endeavor to improve their quality of care, there is a growing recognition of the importance of establishing a culture of patient safety. The main objective of this study was to investigate the cross-level influences of organizational culture on patient safety behavior in Taiwan's hospitals. The authors measured organizational culture (bureaucratic, supportive and innovative culture), patient safety culture and behavior from 788 hospital workers among 42 hospitals in Taiwan. Multilevel analysis was applied to explore the relationship between organizational culture (group level) and patient safety behavior (individual level). Patient safety culture had positive impact on patient safety behavior in Taiwan's hospitals. The results also indicated that bureaucratic, innovative and supportive organizational cultures all had direct influence on patient safety behavior. However, only supportive culture demonstrated significant moderation effect on the relationship between patient safety culture and patient safety behavior. Furthermore, organizational culture strength was shown correlated negatively with patient safety culture variability. Overall, organizational culture plays an important role in patient safety activities. Safety behaviors of hospital staff are partly influenced by the prevailing cultural norms in their organizations and work groups. For management implications, constructed patient priority from management commitment to leadership is necessary. For academic implications, research on patient safety should consider leadership, group dynamics and organizational learning. These factors are important for understanding the barriers and the possibilities embedded in patient safety. Copyright © 2011 John Wiley & Sons, Ltd.

  14. Assessment of occupational safety risks in Floridian solid waste systems using Bayesian analysis.

    PubMed

    Bastani, Mehrad; Celik, Nurcin

    2015-10-01

    Safety risks embedded within solid waste management systems continue to be a significant issue and are prevalent at every step in the solid waste management process. To recognise and address these occupational hazards, it is necessary to discover the potential safety concerns that cause them, as well as their direct and/or indirect impacts on the different types of solid waste workers. In this research, our goal is to statistically assess occupational safety risks to solid waste workers in the state of Florida. Here, we first review the related standard industrial codes to major solid waste management methods including recycling, incineration, landfilling, and composting. Then, a quantitative assessment of major risks is conducted based on the data collected using a Bayesian data analysis and predictive methods. The risks estimated in this study for the period of 2005-2012 are then compared with historical statistics (1993-1997) from previous assessment studies. The results have shown that the injury rates among refuse collectors in both musculoskeletal and dermal injuries have decreased from 88 and 15 to 16 and three injuries per 1000 workers, respectively. However, a contrasting trend is observed for the injury rates among recycling workers, for whom musculoskeletal and dermal injuries have increased from 13 and four injuries to 14 and six injuries per 1000 workers, respectively. Lastly, a linear regression model has been proposed to identify major elements of the high number of musculoskeletal and dermal injuries. © The Author(s) 2015.

  15. Sustaining quality improvement and patient safety training in graduate medical education: lessons from social theory.

    PubMed

    Wong, Brian M; Kuper, Ayelet; Hollenberg, Elisa; Etchells, Edward E; Levinson, Wendy; Shojania, Kaveh G

    2013-08-01

    Despite an official mandate to incorporate formal quality improvement (QI) and patient safety (PS) training into graduate medical education, many QI/PS curricular efforts face implementation challenges and are not sustained. Educators are increasingly turning to sociocultural theories to address issues such as curricular uptake in medical education. The authors conducted a case study using Bourdieu's concepts of "field" and "habitus" to identify theoretically derived strategies that can promote sustained implementation of QI/PS curricula. From October 2010 through May 2011, the authors conducted semistructured interviews with principal authors of studies included in a systematic review of QI/PS curricula and with key informants (identified by study participants) who did not publish on their QI/PS curricular efforts. The authors purposively sampled to theoretical saturation and analyzed data concurrently with iterative data gathering within Bourdieu's theoretical framework. The study included 16 participants representing six specialties in the United States and Canada. Data analysis revealed that academic physicians belong to, and compete for legitimate forms of capital within, two separate but related fields associated with QI/PScurricular implementation: the "academic field" and the "health care delivery field." Respondents used specific strategies toexploit and/or redefine the prevailingforms of legitimate capital in each field to encourage changes inacademic physicians' habitus that would legitimizeQI/PS. Situating study findings in a sociocultural theory enables articulation of concrete strategies that can legitimize QI/PS in the academic and health care delivery fields. These strategies can promote sustained QI/PS curricula in graduate medical education.

  16. 77 FR 27442 - Recruitment of First Responder Network Authority Board of Directors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-10

    ... First Responder Network Authority Board of Directors AGENCY: National Telecommunications and Information... First Responder Network Authority (FirstNet). The Act created FirstNet as an independent authority within NTIA that will establish a single nationwide, interoperable public safety broadband network. The...

  17. 16 CFR 1700.2 - Authority.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Authority. 1700.2 Section 1700.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS POISON PREVENTION PACKAGING § 1700.2 Authority. Authority under the Poison Prevention Packaging Act of 1970 is...

  18. 16 CFR 1700.2 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Authority. 1700.2 Section 1700.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS POISON PREVENTION PACKAGING § 1700.2 Authority. Authority under the Poison Prevention Packaging Act of 1970 is...

  19. 16 CFR 1700.2 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Authority. 1700.2 Section 1700.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS POISON PREVENTION PACKAGING § 1700.2 Authority. Authority under the Poison Prevention Packaging Act of 1970 is...

  20. 16 CFR 1700.2 - Authority.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Authority. 1700.2 Section 1700.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS POISON PREVENTION PACKAGING § 1700.2 Authority. Authority under the Poison Prevention Packaging Act of 1970 is...

  1. 47 CFR 90.515 - Change or cancellation of authorization without hearing.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... hearing. 90.515 Section 90.515 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND... cancellation of authorization without hearing. Every application for authority to engage in developmental... authorization issued pursuant thereto will be accepted with the express understanding of the applicant that it...

  2. Automatic safety belt systems owner usage and attitudes in GM Chevettes and VW Rabbits

    DOT National Transportation Integrated Search

    1980-05-01

    Author's abstract: The study was designed to: (1) evaluate the effectiveness of automatic restraint systems in increasing belt usage, and (2) determine owner attitudes toward the system. Information gathered from owners of vehicles with automatic sys...

  3. Debate on vaccines and autoimmunity: Do not attack the author, yet discuss it methodologically.

    PubMed

    Bragazzi, Nicola Luigi; Watad, Abdulla; Amital, Howard; Shoenfeld, Yehuda

    2017-10-09

    Since Jenner, vaccines and vaccinations have stirred a hot, highly polarized debate, leading to contrasting positions and feelings, ranging from acritical enthusiasm to blind denial. On the one hand, we find anti-vaccination movements which divulge and disseminate misleading information, myths, prejudices, and even frauds, with the main aim of denying that vaccination practices represent a major public health measure, being effective in controlling infectious diseases and safeguarding the wellbeing of entire communities. Recently, the authors of many vaccine safety investigations are being personally criticized rather than the actual science being methodologically assessed and critiqued. Unfortunately, this could result in making vaccine safety science a "hazardous occupation". Critiques should focus on the science and not on the authors and on the scientists that publish reasonably high-quality science suggesting a problem with a given vaccine. These scientists require adequate professional protection so there are not disincentives to publish and to carry out researches in the field. The issues for vaccine safety are not dissimilar to other areas such as medical errors and drug safety. Copyright © 2017 Elsevier Ltd. All rights reserved.

  4. Pharmacy technician-to-pharmacist ratios: a state-driven safety and quality decision.

    PubMed

    Bess, D Todd; Carter, Jason; DeLoach, Lindsey; White, Carol L

    2014-01-01

    To discuss the policy of pharmacy technician-to-pharmacist ratios by comparing Florida as an example of legislative-led authority versus Tennessee as an example of board of pharmacy-led ruling. Over the past 2 years, the Florida legislature has debated the issue of pharmacy staffing ratios, initially leaving the Florida Board of Pharmacy with little authority to advocate for and enact safe technician staffing ratios. Anticipating this situation, the Tennessee Board of Pharmacy created rules to meet pharmacy staffing needs while protecting the authority of the pharmacist-in-charge and promoting patient safety. Before enacting rules, members of the board toured the state and talked about proposed rule changes with pharmacists. The final rule sets the pharmacy technician-to-pharmacist ratio at 2:1 but permits a 4:1 ratio based on public safety considerations and availability of at least two Certified Pharmacy Technicians. Pharmacists and leaders within the profession should conduct further research on appropriate and safe ratios of pharmacy technicians to pharmacists, with a focus on safety and quality of care.

  5. 76 FR 65378 - Safety Zone; The Florida Orchestra Pops in the Park Fireworks Display, Tampa Bay, St. Petersburg, FL

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-21

    ...-AA00 Safety Zone; The Florida Orchestra Pops in the Park Fireworks Display, Tampa Bay, St. Petersburg... temporary safety zone on the waters of Tampa Bay in the vicinity of Spa Beach in St. Petersburg, Florida..., anchoring in, or remaining within the safety zone unless authorized by the Captain of the Port St...

  6. A correction of misinformation regarding Herbalife

    PubMed Central

    Appelhans, Kristy; Najeeullah, Raushanah; Frankos, Vasilios

    2013-01-01

    The authors of the subject article by Senadhi et al have misrepresented the safety and regulatory status of Herbalife’s products. While we are very concerned with the unwarranted and unfavorable publicity that the inaccuracies listed could generate for Herbalife, we would welcome any inquiries that these authors may have to better clarify our commitment to the safety and quality of our products as has been demonstrated in part by our ability to establish positive relationships with regulatory authorities worldwide through continued cooperation and compliance. This letter clarifies the misinformation presented about Herbalife in the subject article. PMID:24179622

  7. Under-reporting of work-related disorders in the workplace: a case study and review of the literature.

    PubMed

    Pransky, G; Snyder, T; Dembe, A; Himmelstein, J

    1999-01-01

    Accurate reporting of work-related conditions is necessary to monitor workplace health and safety, and to identify the interventions that are most needed. Reporting systems may be designed primarily for external agencies (OSHA or workers' compensation) or for the employer's own use. Under-reporting of workplace injuries and illnesses is common due to a variety of causes and influences. Based on previous reports, the authors were especially interested in the role of safety incentive programmes on under-reporting. Safety incentive programmes typically reward supervisors and employees for reducing workplace injury rates, and thus may unintentionally inhibit proper reporting. The authors describe a case study of several industrial facilities in order to illustrate the extent of under-reporting and the reasons for its occurrence. A questionnaire and interview survey was administered to 110 workers performing similar tasks and several managers, health, and safety personnel at each of three industrial facilities. Although less than 5% of workers had officially reported a work-related injury or illness during the past year, over 85% experienced work-related symptoms, 50% had persistent work-related problems, and 30% reported either lost time from work or work restrictions because of their ailment. Workers described several reasons for not reporting their injuries, including fear of reprisal, a belief that pain was an ordinary consequence of work activity or ageing, lack of management responsiveness after prior reports, and a desire not to lose their usual job. Interviews with management representatives revealed administrative and other barriers to reporting, stemming from their desire to attain a goal of no reported injuries, and misconceptions about requirements for recordability. The corporate and facility safety incentives appeared to have an indirect, but significant negative influence on the proper reporting of workplace injuries by workers. A variety of influences may contribute to under-reporting; because of under-reporting, worker surveys and symptom reports may provide more valuable and timely information on risks than recordable injury logs. Safety incentive programmes should be carefully designed to ensure that they provide a stimulus for safety-related changes, and to discourage under-reporting. A case-control study of similar establishments, or data before and after instituting safety incentives, would be required to more clearly establish the role of these programmes in under-reporting.

  8. Design and Implementation of the Harvard Fellowship in Patient Safety and Quality.

    PubMed

    Gandhi, Tejal K; Abookire, Susan A; Kachalia, Allen; Sands, Kenneth; Mort, Elizabeth; Bommarito, Grace; Gagne, Jane; Sato, Luke; Weingart, Saul N

    2016-01-01

    The Harvard Fellowship in Patient Safety and Quality is a 2-year physician-oriented training program with a strong operational orientation, embedding trainees in the quality departments of participating hospitals. It also integrates didactic and experiential learning and offers the option of obtaining a master's degree in public health. The program focuses on methodologically rigorous improvement and measurement, with an emphasis on the development and implementation of innovative practice. The operational orientation is intended to foster the professional development of future quality and safety leaders. The purpose of this article is to describe the design and development of the fellowship. © The Author(s) 2014.

  9. Social learning of fear and safety is determined by the demonstrator's racial group.

    PubMed

    Golkar, Armita; Castro, Vasco; Olsson, Andreas

    2015-01-01

    Social learning offers an efficient route through which humans and other animals learn about potential dangers in the environment. Such learning inherently relies on the transmission of social information and should imply selectivity in what to learn from whom. Here, we conducted two observational learning experiments to assess how humans learn about danger and safety from members ('demonstrators') of an other social group than their own. We show that both fear and safety learning from a racial in-group demonstrator was more potent than learning from a racial out-group demonstrator. © 2015 The Author(s) Published by the Royal Society. All rights reserved.

  10. Doxapram Treatment for Apnea of Prematurity: A Systematic Review.

    PubMed

    Vliegenthart, Roseanne J S; Ten Hove, Christine H; Onland, Wes; van Kaam, Anton H L C

    2017-01-01

    Apnea of prematurity (AOP) is a common complication of preterm birth, for which caffeine is the first treatment of choice. In case of persistent AOP, doxapram has been advocated as an additional therapy. To identify and appraise all existing evidence regarding efficacy and safety of doxapram use for AOP in infants born before 34 weeks of gestational age. All studies reporting on doxapram use for AOP were identified by searching electronic databases, references from relevant studies, and abstracts from the Societies for Pediatric Research. Two reviewers independently assessed study eligibility and quality, and extracted data on study design, patient characteristics, efficacy and safety outcomes. The randomized controlled trials showed less apnea during doxapram treatment when compared to placebo, but no difference in treatment effect when compared to theophylline. No serious adverse effects were reported. We identified 28 observational studies consisting mainly of cohort studies and case series (n = 1,994). There was considerable heterogeneity in study design and quality. Most studies reported a positive effect of doxapram on apnea rate. A few studies reported on long-term outcomes with conflicting results. A range of possible doxapram-related short-term adverse effects were reported, sometimes associated with the use of higher doses. Based on the limited number of studies and level of evidence, no firm conclusions on the efficacy and safety of doxapram in preterm infants can be drawn. For this reason, routine use cannot be recommended. A large multicenter randomized controlled trial is urgently needed to provide more conclusive evidence. © 2016 The Author(s) Published by S. Karger AG, Basel.

  11. Impact of daylight saving time on road traffic collision risk: a systematic review.

    PubMed

    Carey, Rachel N; Sarma, Kiran M

    2017-07-02

    Bills have been put forward in the UK and Republic of Ireland proposing a move to Central European Time (CET). Proponents argue that such a change will have benefits for road safety, with daylight being shifted from the morning, when collision risk is lower, to the evening, when risk is higher. Studies examining the impact of daylight saving time (DST) on road traffic collision risk can help inform the debate on the potential road safety benefits of a move to CET. The objective of this systematic review was to examine the impact of DST on collision risk. Major electronic databases were searched, with no restrictions as to date of publication (the last search was performed in January 2017). Access to unpublished reports was requested through an international expert group. Studies that provided a quantitative analysis of the effect of DST on road safety-related outcomes were included. The primary outcomes of interest were road traffic collisions, injuries and fatalities. Twenty-four studies met the inclusion criteria. Seventeen examined the short-term impact of transitions around DST and 12 examined long-term effects. Findings from the short-term studies were inconsistent. The long-term findings suggested a positive effect of DST. However, this cannot be attributed solely to DST, as a range of road collision risk factors vary over time. The evidence from this review cannot support or refute the assertion that a permanent shift in light from morning to evening will have a road safety benefit. © 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.

  12. The Efficacy and Safety of HA IDF Plus (with Lidocaine) Versus HA IDF (Without Lidocaine) in Nasolabial Folds Injection: A Randomized, Multicenter, Double-Blind, Split-Face Study.

    PubMed

    Lee, Jong-Hun; Kim, Seok-Hwan; Park, Eun-Soo

    2017-04-01

    Injection-related pain of dermal fillers is a consistent and bothersome problem for patients undergoing soft tissue augmentation. Reducing the pain could improve overall patient satisfaction. The purpose of this study was to compare the pain relief, efficacy, and safety of HA IDF plus containing lidocaine with HA IDF without lidocaine during correction of nasolabial folds (NLFs). Sixty-two subjects were enrolled in a randomized, multicenter, double-blind, split-face study of HA IDF plus and HA IDF for NLF correction. For split-face study, HA IDF plus was injected to one side of NLF, and HA IDF was injected to the other side. The first evaluation variable was the injection site pain measured using a 100-mm visual analogue scale (VAS). The second evaluation variables included the global aesthetic improvement scale, wrinkle severity rating scale, and adverse events. Immediately after injection, 91.94% of subjects experienced at least 10 mm decrease in VAS scores at the side injected with HA IDF plus compared with HA IDF, and the rate of subjects is statistically significant. The two fillers were not significantly different in safety profile or wrinkle correction during the follow-up visit. HA IDF plus significantly reduced the injection-related pain during NLFs correction compared with HA IDF without altering clinical outcomes or safety. Both HA IDF plus and HA IDF were considerably tolerated and most adverse reactions were mild and transient. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

  13. Multi-sectoral action for child safety-a European study exploring implicated sectors.

    PubMed

    Scholtes, Beatrice; Schröder-Bäck, Peter; Förster, Katharina; MacKay, Morag; Vincenten, Joanne; Brand, Helmut

    2017-06-01

    Injury to children in Europe, resulting in both death and disability, constitutes a significant burden on individuals, families and society. Inequalities between high and low-income countries are growing. The World Health Organisation Health 2020 strategy calls for inter-sectoral collaboration to address injury in Europe and advocates the whole of government and whole of society approaches to wicked problems. In this study we explore which sectors (e.g. health, transport, education) are relevant for four domains of child safety (intentional injury, water, road and home safety). We used the organigraph methodology, originally developed to demonstrate how organizations work, to describe the governance of child safety interventions. Members of the European Child Safety Alliance, working in the field of child safety in 24 European countries, drew organigraphs of evidence-based interventions. They included the different actors involved and the processes between them. We analyzed the organigraphs by counting the actors presented and categorizing them into sectors using a pre-defined analysis framework. We received 44 organigraphs from participants in 24 countries. Twenty-seven sectors were identified across the four domains. Nine of the 27 identified sectors were classified as 'core sectors' (education, health, home affairs, justice, media, recreation, research, social/welfare services and consumers). This study reveals the multi-sectoral nature of child safety in practice. It provides information for stakeholders working in child safety to help them implement inter-sectoral child safety interventions taking a whole-of-government and whole-of-society approach to health governance. © The Author 2017. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

  14. Under pressure, out of control, or home alone? Reviewing research and policy debates on the occupational health and safety effects of outsourcing and home-based work.

    PubMed

    Quinlan, Michael; Bohle, Philip

    2008-01-01

    The practice of outsourcing or subcontracting of work has grown rapidly in most countries over the past two decades. Outsourcing, de-institutionalization, and a range of other practices have also resulted in a growth of home-based work. Home-based workers, even when not part of a subcontracting process, operate in an isolated situation remote from their employer and other workers. Do such work arrangements expose workers to greater risk of injury, illness, or assault? The authors reviewed international studies of the occupational health and safety (OHS) effects of subcontracting and home-based work undertaken over the past 20 years. Of the 25 studies analyzed, 92 percent found poorer OHS outcomes. The studies were examined for clues about the reasons for these negative outcomes. The authors also identified similarities and differences between subcontracting and home-based work. Despite the evidence of poor OHS outcomes, research into outsourcing has stalled in recent years. With notable exceptions, governments have taken little account of findings on these work arrangements in their laws and policies, in part because neoliberal ideas dominate national and global policy agendas. The authors examine policy challenges and regulatory responses and make suggestions for future research and policy interventions.

  15. Etomidate anaesthesia by immersion in oriental fire-bellied toads (Bombina orientalis).

    PubMed

    d'Ovidio, D; Spadavecchia, C; Angeli, G; Adami, C

    2015-10-01

    The objective of the present study was to evaluate the efficacy and the safety of etomidate anaesthesia by immersion technique in Bombina orientalis. The study comprised two phases. The first phase was carried out to identify the etomidate concentration capable of producing anaesthetic induction, as well as surgical anaesthesia, in the toads. The second phase was aimed at testing that concentration in eight additional animals. Etomidate administered via immersion at a concentration of 37.5 mg/L produced effective anaesthesia in oriental fire-bellied toads. The average duration of surgical anaesthesia was 20 min. All the toads enrolled in the study survived the anaesthesia and long-term complications did not occur. However, undesired side-effects, namely itching, myoclonus and prolonged recovery, were noticed during the perianaesthetic period. The authors concluded that etomidate anaesthesia by immersion, at a concentration of 37.5 mg/L, is suitable in oriental fire-bellied toads and produces anaesthesia of a depth and duration that is sufficient to allow the completion of various experimental procedures, without resulting in lethal complications. However, the occurrence of undesired side-effects opens a debate on the safety of this anaesthetic technique, and imposes the need for further investigation prior to proposing the latter for routine laboratory practice. © The Author(s) 2015.

  16. Bovine thrombin safety reporting: an example of study design and publication bias.

    PubMed

    Crean, Sheila; Michels, Shannon L; Moschella, Kevin; Reynolds, Matthew W

    2010-01-01

    Bovine thrombin, a popular hemostat and sealant since 1945, has recently been subjected to clinical trial testing due to reformulations in 1998. We sought to compare adverse event rates of early observational studies with those of later interventional trials. A MEDLINE-based literature search in publications that report safety in bovine thrombin exposed surgical patients was extracted and reviewed. In 38 studies, about half were case reports and 31.5% were interventional trials. In case reports, 41% of authors reported severe coagulopathic adverse events. In contrast, whereas blood complications were common in large trials, no association of harm was established for bovine thrombin product exposure and/or immunization. In this review, later clinical trials failed to reproduce the common and severe coagulopathy predicted by earlier observational studies in bovine exposed patients. This example illustrates that perceptions of safety can change as a function of study design, even for a widely adopted, well established biologic such as thrombin. Caution must be exercised in interpreting evidence from observational studies alone.

  17. [Recommendations for inspections of the French nuclear safety authority].

    PubMed

    Rousse, C; Chauvet, B

    2015-10-01

    The French nuclear safety authority is responsible for the control of radiation protection in radiotherapy since 2002. Controls are based on the public health and the labour codes and on the procedures defined by the controlled health care facility for its quality and safety management system according to ASN decision No. 2008-DC-0103. Inspectors verify the adequacy of the quality and safety management procedures and their implementation, and select process steps on the basis of feedback from events notified to ASN. Topics of the inspection are communicated to the facility at the launch of a campaign, which enables them to anticipate the inspectors' expectations. In cases where they are not physicians, inspectors are not allowed to access information covered by medical confidentiality. The consulted documents must therefore be expunged of any patient-identifying information. Exchanges before the inspection are intended to facilitate the provision of documents that may be consulted. Finally, exchange slots between inspectors and the local professionals must be organized. Based on improvements achieved by the health care centres and on recommendations from a joint working group of radiotherapy professionals and the nuclear safety authority, changes will be made in the control procedure that will be implemented when developing the inspection program for 2016-2019. Copyright © 2015. Published by Elsevier SAS.

  18. Laser and high-frequency cauthery gingivectomy in nonperiodontal indications: assessment and comparison of techniques

    NASA Astrophysics Data System (ADS)

    Bartak, Petr; Smucler, Roman

    2003-06-01

    The authors have verified the efficiency and safety of laser and high-frequency gingivectomy in non-periodontal indications. Within a prospective, non-selective study, they treated and monitored 357 dental areas in 139 teeth.Out of the total number, 248 areas were treated wtih a diode laser, 980nm; 109 areas with high-frequency electrocautery. The following parameters were monitored: a) regeneration of the marginal gingiva; b) generation of iatrogenic recessions or periodontal pockets; c) bleeding from gingival sulcus during probing; d) changes in tooth vitality; e) patient's subjective evaluation. The authors identified a high degree of safety in both laser and high-frequency gingivectomy, with no significant difference between these two methods. Laser gingivectomy appears to have a wider indication range, while high-frequency gingivectomy requires lower financial expenses.

  19. Identifying primary care patient safety research priorities in the UK: a James Lind Alliance Priority Setting Partnership.

    PubMed

    Morris, Rebecca Lauren; Stocks, Susan Jill; Alam, Rahul; Taylor, Sian; Rolfe, Carly; Glover, Steven William; Whitcombe, Joanne; Campbell, Stephen M

    2018-02-28

    To identify the top 10 unanswered research questions for primary care patient safety research. A modified nominal group technique. UK. Anyone with experience of primary care including: patients, carers and healthcare professionals. 341 patients and 86 healthcare professionals submitted questions. A top 10, and top 30, future research questions for primary care patient safety. 443 research questions were submitted by 341 patients and 86 healthcare professionals, through a national survey. After checking for relevance and rephrasing, a total of 173 questions were collated into themes. The themes were largely focused on communication, team and system working, interfaces across primary and secondary care, medication, self-management support and technology. The questions were then prioritised through a national survey, the top 30 questions were taken forward to the final prioritisation workshop. The top 10 research questions focused on the most vulnerable in society, holistic whole-person care, safer communication and coordination between care providers, work intensity, continuity of care, suicide risk, complex care at home and confidentiality. This study was the first national prioritisation exercise to identify patient and healthcare professional priorities for primary care patient safety research. The research priorities identified a range of important gaps in the existing evidence to inform everyday practice to address primary care patient safety. © 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 expressly granted.

  20. 36 CFR 1004.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 36 Parks, Forests, and Public Property 3 2014-07-01 2014-07-01 false Authorized emergency vehicles. 1004.3 Section 1004.3 Parks, Forests, and Public Property PRESIDIO TRUST VEHICLES AND TRAFFIC SAFETY § 1004.3 Authorized emergency vehicles. (a) The operator of an authorized emergency vehicle, when...

  1. 36 CFR 1004.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 3 2010-07-01 2010-07-01 false Authorized emergency vehicles. 1004.3 Section 1004.3 Parks, Forests, and Public Property PRESIDIO TRUST VEHICLES AND TRAFFIC SAFETY § 1004.3 Authorized emergency vehicles. (a) The operator of an authorized emergency vehicle, when...

  2. 33 CFR 147.5 - Delegation of authority.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false Delegation of authority. 147.5 Section 147.5 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OUTER CONTINENTAL SHELF ACTIVITIES SAFETY ZONES § 147.5 Delegation of authority. The authority to...

  3. 33 CFR 147.5 - Delegation of authority.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Delegation of authority. 147.5 Section 147.5 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OUTER CONTINENTAL SHELF ACTIVITIES SAFETY ZONES § 147.5 Delegation of authority. The authority to...

  4. 10 CFR 76.81 - Authorized use of radioactive material.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Authorized use of radioactive material. 76.81 Section 76.81 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.81 Authorized use of radioactive material. Unless otherwise authorized by law, the Corporation...

  5. 10 CFR 76.81 - Authorized use of radioactive material.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Authorized use of radioactive material. 76.81 Section 76.81 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.81 Authorized use of radioactive material. Unless otherwise authorized by law, the Corporation...

  6. 10 CFR 76.81 - Authorized use of radioactive material.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Authorized use of radioactive material. 76.81 Section 76.81 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.81 Authorized use of radioactive material. Unless otherwise authorized by law, the Corporation...

  7. 10 CFR 76.81 - Authorized use of radioactive material.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Authorized use of radioactive material. 76.81 Section 76.81 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.81 Authorized use of radioactive material. Unless otherwise authorized by law, the Corporation...

  8. 10 CFR 76.81 - Authorized use of radioactive material.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Authorized use of radioactive material. 76.81 Section 76.81 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.81 Authorized use of radioactive material. Unless otherwise authorized by law, the Corporation...

  9. Achievements and Perspectives of the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Louvat, D.; Lacoste, A.C.

    The Joint Convention on the Safety of Spent Fuel management and on the Safety of Radioactive Waste Management is the first legal instrument to directly address the safety of spent fuel and radioactive waste management on a global scale. The Joint Convention entered into force in 2001. This paper describes its process and its main achievements to date. The perspectives to establish of a Global Waste Safety Regime based on the Joint Convention are also discussed. (authors)

  10. The power of collaboration with patient safety programs: building safe passage for patients, nurses, and clinical staff.

    PubMed

    Kerfoot, Karlene M; Rapala, Kathryn; Ebright, Patricia; Rogers, Suzanne M

    2006-12-01

    Patient safety is a relatively new field, with many opinions and few effectively proven approaches. One factor is clear: optimal patient safety outcomes cannot be achieved in isolation. Although it is well recognized that multidisciplinary collaboration in the healthcare setting is necessary to effect patient safety, collaboration with resources external to healthcare-academia and industry in particular-will not only aid but also quicken the patient safety efforts. The authors outline a healthcare system's use of all available resources to build a patient safety program.

  11. Design of the Blood Pressure Goals in Dialysis pilot study.

    PubMed

    Gul, Ambreen; Miskulin, Dana; Gassman, Jennifer; Harford, Antonia; Horowitz, Bruce; Chen, Joline; Paine, Susan; Bedrick, Edward; Kusek, John W; Unruh, Mark; Zager, Philip

    2014-02-01

    Cardiovascular disease (CVD) is markedly increased among hemodialysis (HD) patients. Optimizing blood pressure (BP) among HD patients may present an important opportunity to reduce the disparity in CVD rates between HD patients and the general population. The optimal target predialysis systolic BP (SBP) among HD patients is unknown. Current international guidelines, calling for a predialysis SBP < 140 mm Hg, are based on the opinion and extrapolation from the general population. Existing randomized controlled trials (RCTs) were small and did not include prespecified BP targets. The authors described the design of the Blood Pressure in Dialysis (BID) Study, a pilot, multicenter RCT where HD patients are randomized to either a target-standardized predialysis SBP of 110 to 140 mm Hg or 155 to 165 mm Hg. This is the first study to randomize HD patients to 2 different SBP targets. Primary outcomes are feasibility and safety. Feasibility parameters include recruitment and retention rates, adherence with prescribed BP measurements and achievement and maintenance of selected BP targets. Safety parameters include rates of hypotension and other adverse and serious adverse events. The authors obtained preliminary data on changes in left ventricular mass, aortic pulse wave velocity, vascular access thromboses and health-related quality of life across study arms, which may be the secondary outcomes in the full-scale study. The data acquired in the pilot RCT will determine the feasibility and safety and inform the design of a full-scale trial, powered for hard outcomes, which may require 2000 participants.

  12. Power learning or path dependency? Investigating the roots of the European Food Safety Authority.

    PubMed

    Roederer-Rynning, Christilla; Daugbjerg, Carsten

    2010-01-01

    A key motive for establishing the European Food Safety Authority (EFSA) was restoring public confidence in the wake of multiplying food scares and the BSE crisis. Scholars, however, have paid little attention to the actual political and institutional logics that shaped this new organization. This article explores the dynamics underpinning the making of EFSA. We examine the way in which learning and power shaped its organizational architecture. It is demonstrated that the lessons drawn from the past and other models converged on the need to delegate authority to an external agency, but diverged on its mandate, concretely whether or not EFSA should assume risk management responsibilities. In this situation of competitive learning, power and procedural politics conditioned the mandate granted to EFSA. The European Commission, the European Parliament and the European Council shared a common interest in preventing the delegation of regulatory powers to an independent EU agency in food safety policy.

  13. Nevada State plan; final approval determination. Occupational Safety and Health Administration (OSHA), U.S. Department of Labor. Final State plan approval--Nevada.

    PubMed

    2000-04-18

    This document amends OSHA's regulations to reflect the Assistant Secretary's decision granting final approval to the Nevada State plan. As a result of this affirmative determination under section 18(e) of the Occupational Safety and Health Act of 1970, Federal OSHA's standards and enforcement authority no longer apply to occupational safety and health issues covered by the Nevada plan, and authority for Federal concurrent jurisdiction is relinquished. Federal enforcement jurisdiction is retained over any private sector maritime employment, private sector employers on Indian land, and any contractors or subcontractors on any Federal establishment where the land is exclusive Federal jurisdiction. Federal jurisdiction remains in effect with respect to Federal government employers and employees. Federal OSHA will also retain authority for coverage of the United States Postal Service (USPS), including USPS employees, contract employees, and contractor-operated facilities engaged in USPS mail operations.

  14. Effect of safety issues with HIV drugs on the approval process of other drugs in the same class: an analysis of European Public Assessment Reports.

    PubMed

    Arnardottir, Arna H; Haaijer-Ruskamp, Flora M; Straus, Sabine M J; de Graeff, Pieter A; Mol, Peter G M

    2011-11-01

    Knowledge on the safety of new medicines is limited at the time of market entry. Nearly half of all drugs used to treat HIV registered in the EU required ≥1 Direct Healthcare Professional Communication (DHPC) in the past 10 years for safety issues identified post-approval. The aim was to evaluate the extent to which regulators and industry have addressed the risk of safety issues for HIV drugs based on prior experience with other drugs in the same class and whether doing so impacts development time of these drugs. HIV drugs receiving ≥1 DHPC in the Netherlands between January 1999 and December 2008 were identified. Each drug with a DHPC ('index' drug) was paired with subsequently approved HIV drug(s) in the same class (Anatomical Therapeutic Chemical [ATC] 4th level) ['follow-on' drugs]. Characteristics of safety issues were extracted from the DHPCs of the 'index' drugs. European Public Assessment Reports (EPARs) were reviewed regarding whether the safety issues had been considered during development and approval. Consideration of previously identified safety issues in 'follow-on' drug applications was assessed regarding attention paid to adverse drug reaction (ADR) symptoms in pre-marketing studies, Summary of Product Characteristics (SmPC) and postmarketing commitments, and whether size of the safety population was in accordance with Regulatory guidelines. 'Index' drugs were also paired with drugs in the same class already on the market ('older' drugs). For 'older' drugs, we identified whether the safety issue led to appropriate changes in the current SmPC (January 2011) compared with the SmPC at the time of marketing authorization. Clinical development time was assessed using time from first patent application to market authorization as proxy, and comparison was made between 'index' and 'follow-on' drugs. For 9 (43%) of the 21 centrally authorized HIV drugs, 11 serious safety issues that required a DHPC were identified. Two drugs were excluded from our analysis (DHPCs related to contamination/medication error). Six 'index' drugs were paired, each with one to six 'follow-on' drugs. Three concerned drug-drug interactions (DDIs); the other three were intracranial haemorrhage, neuromuscular weakness and severe skin/hepatic reactions. All but one 'follow-on' drug had information in the EPAR on that specific ADR (i.e. attention was paid to the ADR). The DDIs were addressed in pre-marketing studies and/or the SmPC. Two of the other ADRs were addressed by postmarketing surveillance commitments; intracranial haemorrhage was not addressed. Three safety issues for two 'index' drugs could not be paired with a 'follow-on' drug as no drug in the same class was approved after the corresponding DHPCs were issued. Five of the nine safety issues were added to at least one of the current SmPCs for the 'older' drugs already on the market at the time of DHPC issue. Two safety issues were already in the SmPC of the 'older' drugs at time of market approval and two were not introduced into the SmPC of 'older' drugs. Population size to assess short-term safety complied with the guidelines for four 'index', seven 'follow-on' and three 'older' drugs; population size to assess long-term safety complied for one, three and two drugs, respectively. For five drugs, EPARs did not provide adequate information on population size. No statistically significant difference in development time between 'index' and 'follow-on' drugs was found. Generally, safety issues were taken into account in the approval process of other drugs in the class. The approaches were different and determined by the nature of the ADR. Taking safety issues into account in the approval process did not seem to impact on the time taken to perform the pre-approval clinical programme.

  15. Safety and Effectiveness of the Denali Inferior Vena Cava Filter: Intermediate Follow-Up Results.

    PubMed

    Reis, Stephen P; Kovoor, Jerry; Sutphin, Patrick D; Toomay, Seth; Trimmer, Clayton; Pillai, Anil; Reddick, Mark; Kalva, Sanjeeva P

    2016-08-01

    The purpose of the study is to evaluate the clinical safety and effectiveness of the Denali (Bard, Tempe, Arizona) retrievable inferior vena cava (IVC) filter. In this retrospective study, authors reviewed the data of Denali IVC filters placed at their institution between 2013 and 2015. The clinical presentation, indications, and procedure-related complications during placement and retrieval were evaluated. The frequency of post filter pulmonary embolism (PE) and filter-related complications was assessed. Denali filters were placed in 87 patients (47 males; mean age: 56 years). Twenty patients presented with PE, 45 with deep vein thrombosis (DVT), and 21 with both PE and DVT, 1 filter was placed prophylactically before surgery. Indications for filter placement included contraindications to anticoagulation (AC; n = 80), failure of AC (n = 4), and complications of AC (n = 3). No patients had PE on follow-up imaging after filter placement. Retrieval was attempted in 31 patients after a mean period of 125 days (range: 34-324 days). The filter was successfully removed in 31 (100%) patients. Follow-up imaging, available in 71 (82%) patients (range: 2-538 days), demonstrated penetration of 15 legs in 5 patients, caval thrombus in 3, 1 resulting in caval occlusion, <15° filter tilt in 5, and no leg fractures or crossed legs. The Denali filter is safe during deployment and readily retrievable. The overall safety following deployment is similar to those reported in the literature, and the incidence of filter fractures and migration appears to be less than the previous generation of Bard devices. © The Author(s) 2016.

  16. Clinical efficacy and safety of imepitoin in comparison with phenobarbital for the control of idiopathic epilepsy in dogs.

    PubMed

    Tipold, A; Keefe, T J; Löscher, W; Rundfeldt, C; de Vries, F

    2015-04-01

    The anticonvulsant activity and safety of imepitoin, a novel antiepileptic drug licensed in the European Union, were evaluated in a multicentre field efficacy study as well as in a safety study under laboratory conditions. Efficacy of imepitoin was compared with phenobarbital in 226 client-owned dogs in a blinded parallel group design. The administration of imepitoin twice daily in incremental doses of 10, 20 or 30 mg/kg demonstrated comparable efficacy to phenobarbital in controlling seizures in dogs. The frequency of adverse events including somnolence/sedation, polydipsia and increased appetite was significantly higher in the phenobarbital group. In phenobarbital-treated dogs, significantly increased levels of alkaline phosphatase, gamma-glutamyl-transferase and other liver enzymes occurred, while no such effect was observed in the imepitoin group. In a safety study under laboratory conditions, healthy beagle dogs were administered 0, 30, 90 or 150 mg/kg imepitoin twice daily for 26 weeks. A complete safety evaluation including histopathology was included in the study. A no-observed-adverse-event level of 90 mg/kg twice daily was determined. These results indicate that imepitoin is a potent and safe antiepileptic drug for dogs. © 2014 The Authors. Journal of Veterinary Pharmacology and Therapeutics Published by John Wiley & Sons Ltd.

  17. Safety And Promotion in the Federal Aviation Administration- Enabling Safe and Successful Commercial Space Transportation

    NASA Astrophysics Data System (ADS)

    Repcheck, Randall J.

    2010-09-01

    The United States Federal Aviation Administration’s Office of Commercial Space Transportation(AST) authorizes the launch and reentry of expendable and reusable launch vehicles and the operation of launch and reentry sites by United States citizens or within the United States. It authorizes these activities consistent with public health and safety, the safety of property, and the national security and foreign policy interests of the United States. In addition to its safety role, AST has the role to encourage, facilitate, and promote commercial space launches and reentries by the private sector. AST’s promotional role includes, among other things, the development of information of interest to industry, the sharing of information of interest through a variety of methods, and serving as an advocate for Commercial Space Transportation within the United States government. This dual safety and promotion role is viewed by some as conflicting. AST views these two roles as complementary, and important for the current state of commercial space transportation. This paper discusses how maintaining a sound safety decision-making process, maintaining a strong safety culture, and taking steps to avoid complacency can together enable safe and successful commercial space transportation.

  18. 75 FR 55360 - In the Matter of Mattingly Testing Services, Inc. Molt, MT; Order Revoking License (Effective...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-10

    ... radiation safety officer, and due to expire on February 28, 2016. The license authorizes Mattingly to... effectiveness of Mattingly's radiation safety and compliance programs by commencing an assessment of Mattingly's radiation safety program within 30 days of NRC's approval of the consultant; by reviewing Mattingly's...

  19. 76 FR 37646 - Safety Zone; Northern California Annual Fireworks Events, Fourth of July Fireworks, City of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-28

    ... Zone; Northern California Annual Fireworks Events, Fourth of July Fireworks, City of Sausalito... Guard will enforce the Fourth of July Fireworks, City of Sausalito annual safety zone. This action is... through, or anchoring in the safety zone, unless authorized by the Patrol Commander (PATCOM). DATES: The...

  20. 75 FR 33162 - Airworthiness Directives; Microturbo Saphir 20 Model 095 Auxiliary Power Units (APUs)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-11

    ... information (MCAI) issued by the European Aviation Safety Agency (EASA) to identify and correct an unsafe... States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106... the AD docket. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety...

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