A pilot study on the evaluation of medical student documentation: assessment of SOAP notes.

PubMed

Seo, Ji-Hyun; Kong, Hyun-Hee; Im, Sun-Ju; Roh, HyeRin; Kim, Do-Kyong; Bae, Hwa-Ok; Oh, Young-Rim

2016-06-01

The purpose of this study was evaluation of the current status of medical students' documentation of patient medical records. We checked the completeness, appropriateness, and accuracy of 95 Subjective-Objective-Assessment-Plan (SOAP) notes documented by third-year medical students who participated in clinical skill tests on December 1, 2014. Students were required to complete the SOAP note within 15 minutes of an standard patient (SP)-encounter with a SP complaining rhinorrhea and warring about meningitis. Of the 95 SOAP notes reviewed, 36.8% were not signed. Only 27.4% documented the patient's symptoms under the Objective component, although all students completed the Subjective notes appropriately. A possible diagnosis was assessed by 94.7% students. Plans were described in 94.7% of the SOAP notes. Over half the students planned workups (56.7%) for diagnosis and treatment (52.6%). Accurate documentation of the symptoms, physical findings, diagnoses, and plans were provided in 78.9%, 9.5%, 62.1%, and 38.0% notes, respectively. Our results showed that third-year medical students' SOAP notes were not complete, appropriate, or accurate. The most significant problems with completeness were the omission of students' signatures, and inappropriate documentation of the physical examinations conducted. An education and assessment program for complete and accurate medical recording has to be developed.

Safety Auditing and Assessments

NASA Technical Reports Server (NTRS)

Goodin, James Ronald (Ronnie)

2005-01-01

Safety professionals typically do not engage in audits and independent assessments with the vigor as do our quality brethren. Taking advantage of industry and government experience conducting value added Independent Assessments or Audits benefits a safety program. Most other organizations simply call this process "internal audits." Sources of audit training are presented and compared. A relation of logic between audit techniques and mishap investigation is discussed. An example of an audit process is offered. Shortcomings and pitfalls of auditing are covered.

Safety Auditing and Assessments

NASA Astrophysics Data System (ADS)

Goodin, Ronnie

2005-12-01

Safety professionals typically do not engage in audits and independent assessments with the vigor as do our quality brethren. Taking advantage of industry and government experience conducting value added Independent Assessments or Audits benefits a safety program. Most other organizations simply call this process "internal audits." Sources of audit training are presented and compared. A relation of logic between audit techniques and mishap investigation is discussed. An example of an audit process is offered. Shortcomings and pitfalls of auditing are covered.

Safety assessment of a novel active ingredient, acetyl aspartic acid, according to the EU Cosmetics Regulation and the Scientific Committee on Consumer Safety guidelines.

PubMed

Daly, P; Moran, G

2015-10-01

Acetyl aspartic acid (A-A-A) was proposed as a new novel active ingredient for use in cosmetics. The safety of A-A-A was assessed by following an in-house-developed 'New Ingredient Testing Strategy', which was designed in accordance with the Scientific Committee on Consumer Safety (SCCS) notes of guidance and the requirements of Annex I of the EU Cosmetics Regulation. The aim of the project was to determine whether A-A-A was safe for use in cosmetics and to determine a maximum permitted safe level in the formulations. A literature review was conducted, consulting over 40 different information sources. This highlighted a number of gaps which required testing data. A-A-A was tested for phototoxicity according to OECD test guideline 432, skin irritation according to OECD test guideline 439 and eye irritation according to OECD test guideline 437. Dermal absorption of A-A-A was measured according to OECD test guideline 428 and was used to calculate the margin of safety (MoS). Finally, A-A-A was tested in a human repeat insult patch test (HRIPT) and a 14-day in-use tolerance study. A-A-A was non-phototoxic and was non-irritating to skin and eyes in in vitro testing. Dermal absorption was calculated to be 5%. The MoS for A-A-A was 351, at a level of 5%, for all cosmetic product types, indicating no systemic safety toxicity concern. A-A-A at 5% under occlusive patch on a panel of 50 adult volunteers induced no skin irritation or allergic reaction in the HRIPT study. Finally, repeated application of A-A-A to the periocular area, twice per day for 14 days, in 21 female volunteers, demonstrated that 1% A-A-A was well tolerated following dermatological and ophthalmological assessment in a cosmetic formulation. A-A-A was assessed as safe by the cosmetic safety assessor for use in cosmetics at a level of 5% in all cosmetic product types, in line with the requirements of the EU Cosmetics Regulation and in accordance with the SCCS notes of guidance. © 2015 Society of Cosmetic

Assessment of Electrical Safety in Afghanistan

DTIC Science & Technology

2009-07-24

effectiveness of command efforts to ensure the electrical safety of Department of Defense occupied and constructed facilities in Afghanistan. We...March 31, 2009, we announced the Assessment of Electrical Safety in Afghanistan. The objective of this assessment was to review the effectiveness of...used contractors to review and identify electrical deficiencies to include life, health , and safety issues at FOBs. According to TF POWER

Euro-NOTES Status Paper: from the concept to clinical practice.

PubMed

Fuchs, K H; Meining, A; von Renteln, D; Fernandez-Esparrach, G; Breithaupt, W; Zornig, C; Lacy, A

2013-05-01

The concept of natural orifice transluminal endoscopic surgery (NOTES) consists of the reduction of access trauma by using a natural orifice access to the intra-abdominal cavity. This could possibly lead to less postoperative pain, quicker recovery from surgery, fewer postoperative complications, fewer wound infections, and fewer long-term problems such as hernias. The Euro-NOTES Foundation has organized yearly meetings to work on this concept to bring it safely into clinical practice. The aim of this Euro-NOTES status update is to assess the yearly scientific working group reports and provide an overview on the current clinical practice of NOTES procedures. After the Euro-NOTES meeting 2011 in Frankfurt, Germany, an analysis was started regarding the most important topics of the European working groups. All prospectively documented information was gathered from Euro-NOTES and D-NOTES working groups from 2007 to 2011. The top five topics were analyzed. The statements of the working group activities demonstrate the growing information and changing insights. The most important selected topics were infection issue, peritoneal access, education and training, platforms and new technology, closure, suture, and anastomosis. The focus on research topics changed over time. The principle of hybrid access has overcome the technical and safety limitations of pure NOTES. Currently the following NOTES access routes are established for several indications: transvaginal access for cholecystectomy, appendectomy and colon resections; transesophageal access for myotomy; transgastric access for full-thickness small-tumor resections; and transanal/transcolonic access for rectal and colon resections. NOTES and hybrid NOTES techniques have emerged for all natural orifices and were introduced into clinical practice with a good safety record. There are different indications for different natural orifices. Each technique has been optimized for the purpose of finding a safe and realistic

Comparison of case note review methods for evaluating quality and safety in health care.

PubMed

Hutchinson, A; Coster, J E; Cooper, K L; McIntosh, A; Walters, S J; Bath, P A; Pearson, M; Young, T A; Rantell, K; Campbell, M J; Ratcliffe, J

2010-02-01

To determine which of two methods of case note review--holistic (implicit) and criterion-based (explicit)--provides the most useful and reliable information for quality and safety of care, and the level of agreement within and between groups of health-care professionals when they use the two methods to review the same record. To explore the process-outcome relationship between holistic and criterion-based quality-of-care measures and hospital-level outcome indicators. Case notes of patients at randomly selected hospitals in England. In the first part of the study, retrospective multiple reviews of 684 case notes were undertaken at nine acute hospitals using both holistic and criterion-based review methods. Quality-of-care measures included evidence-based review criteria and a quality-of-care rating scale. Textual commentary on the quality of care was provided as a component of holistic review. Review teams comprised combinations of: doctors (n = 16), specialist nurses (n = 10) and clinically trained audit staff (n = 3) and non-clinical audit staff (n = 9). In the second part of the study, process (quality and safety) of care data were collected from the case notes of 1565 people with either chronic obstructive pulmonary disease (COPD) or heart failure in 20 hospitals. Doctors collected criterion-based data from case notes and used implicit review methods to derive textual comments on the quality of care provided and score the care overall. Data were analysed for intrarater consistency, inter-rater reliability between pairs of staff using intraclass correlation coefficients (ICCs) and completeness of criterion data capture, and comparisons were made within and between staff groups and between review methods. To explore the process-outcome relationship, a range of publicly available health-care indicator data were used as proxy outcomes in a multilevel analysis. Overall, 1473 holistic and 1389 criterion-based reviews were undertaken in the first part of the study

Integrated deterministic and probabilistic safety analysis for safety assessment of nuclear power plants

DOE PAGES

Di Maio, Francesco; Zio, Enrico; Smith, Curtis; ...

2015-07-06

The present special issue contains an overview of the research in the field of Integrated Deterministic and Probabilistic Safety Assessment (IDPSA) of Nuclear Power Plants (NPPs). Traditionally, safety regulation for NPPs design and operation has been based on Deterministic Safety Assessment (DSA) methods to verify criteria that assure plant safety in a number of postulated Design Basis Accident (DBA) scenarios. Referring to such criteria, it is also possible to identify those plant Structures, Systems, and Components (SSCs) and activities that are most important for safety within those postulated scenarios. Then, the design, operation, and maintenance of these “safety-related” SSCs andmore » activities are controlled through regulatory requirements and supported by Probabilistic Safety Assessment (PSA).« less

Training on N.O.T.E.S.: from history we learn.

PubMed

Al-Akash, M; Boyle, E; Tanner, W A

2009-06-01

Surgical errors occurring early in the learning curve of laparoscopic surgery providers delayed the uptake and progress of minimally invasive surgery (MIS) for years. This taught us a valuable lesson; innovations in surgical techniques should not be rapidly implemented until all aspects including applicability, feasibility and safety have been fully tested. In 2005, the Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR) published a white paper highlighting the barriers to NOTES development and identifying key elements for its progress. One of these elements is the training of future providers. Proficiency-based, virtual reality simulation will offer a feasible alternative to animal testing once the safety and efficacy parameters of NOTES are established. Recent advances in imaging including computed tomography (CT) scanning, magnetic resonance imaging (MRI) scanning, and ultrasound (US) scanning can offer improved image registration and real-time tracking. Combining these advanced imaging technologies with the newly designed virtual reality simulators will result in a fully comprehensive simulation curriculum which will offer a unique facility for future NOTES providers to train anytime, anywhere, and as much as they need to in order to achieve the pre-set proficiency levels for a variety of NOTES procedures. Furthermore they will incorporate patient-specific anatomical models obtained from patient imaging and uploaded onto the simulator to ensure face reliability and validity assurance. Training in a clean, safe environment with proximate feedback and performance analysis will help accelerate the learning curve and therefore improve patients' safety and outcomes in order to maximize the benefits of innovative access procedures such as NOTES.

Constantly evolving safety assessment protocols for GM foods.

PubMed

Sesikeran, B; Vasanthi, Siruguri

2008-01-01

he introduction of GM foods has led to the evolution of a food safety assessment paradigm that establishes safety of the GM food relative to its conventional counterpart. The GM foods currently approved and marketed in several countries have undergone extensive safety testing under a structured safety assessment framework evolved by international organizations like FAO, WHO, Codex and OECD. The major elements of safety assessment include molecular characterization of inserted genes and stability of the trait, toxicity and allergenicity potential of the expressed substances, compositional analysis, potential for gene transfer to gut microflora and unintentional effects of the genetic modification. As more number and type of food crops are being brought under the genetic modification regime, the adequacy of existing safety assessment protocols for establishing safety of these foods has been questioned. Such crops comprise GM crops with higher agronomic vigour, nutritional or health benefit/ by modification of plant metabolic pathways and those expressing bioactive substances and pharmaceuticals. The safety assessment challenges of these foods are the potential of the methods to detect unintentional effects with higher sensitivity and rigor. Development of databases on food compositions, toxicants and allergens is currently seen as an important aid to development of safety protocols. With the changing global trends in genetic modification technology future challenge would be to develop GM crops with minimum amount of inserted foreign DNA so as to reduce the burden of complex safety assessments while ensuring safety and utility of the technology.

Assessing safety awareness and knowledge and behavioral change among West Virginia loggers

PubMed Central

Helmkamp, J; Bell, J; Lundstrom, W; Ramprasad, J; Haque, A

2004-01-01

Objective: To determine if a video used during logger training influences safety attitude, knowledge, and workplace habits. Method: From April 2002 to October 2003, loggers receiving training through the West Virginia Division of Forestry were given a new safety module. This consisted of a pre-training survey, viewing video, brief introduction to field safety guide, and an immediate post-training survey. Six months after training, loggers were contacted by telephone to assess workplace behavioral changes. Results: 1197 loggers attended 80 training sessions and completed surveys; 21% were contacted at follow up. Pre-training surveys indicated that half said "accidents" were part of the job and had experienced a "close call" in their work. An overwhelming majority felt that safety management and periodic meetings were important. Over 75% indicated they would not take risks in order to make a profit. Several statistically significant improvements were noted in safety knowledge after viewing the video: logger's location in relation to the tree stump during fatal incidents and the pictorial identification of an overloaded truck and the safest cutting notch. At follow up, many of the loggers said they related to the real life victim stories portrayed in the video. Further, the field guide served as a quick and easy reference and taught them valuable tips on safe cutting and felling. Conclusions: Significant changes in safety knowledge and attitude among certified loggers resulted from viewing the video during training. Subsequent use of the video and field guide at the worksite encouraged positive change in self reported work habits and practices. PMID:15314051

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.

Research notes : safety at high-speed intersections.

DOT National Transportation Integrated Search

2010-04-01

A 2010 study for ODOT by researchers at the Oregon State University School of Civil and Construction Engineering titled, Evaluating Safety and Operations of High-Speed Signalized Intersections, examined effective means for improving safety at isolate...

When doctors share visit notes with patients: a study of patient and doctor perceptions of documentation errors, safety opportunities and the patient-doctor relationship.

PubMed

Bell, Sigall K; Mejilla, Roanne; Anselmo, Melissa; Darer, Jonathan D; Elmore, Joann G; Leveille, Suzanne; Ngo, Long; Ralston, James D; Delbanco, Tom; Walker, Jan

2017-04-01

Patient advocates and safety experts encourage adoption of transparent health records, but sceptics worry that shared notes may offend patients, erode trust or promote defensive medicine. As electronic health records disseminate, such disparate views fuel policy debates about risks and benefits of sharing visit notes with patients through portals. Presurveys and postsurveys from 99 volunteer doctors at three US sites who participated in OpenNotes and postsurveys from 4592 patients who read at least one note and submitted a survey. Patients read notes to be better informed and because they were curious; about a third read them to check accuracy. In total, 7% (331) of patients reported contacting their doctor's office about their note. Of these, 29% perceived an error, and 85% were satisfied with its resolution. Nearly all patients reported feeling better (37%) or the same (62%) about their doctor. Patients who were older (>63), male, non-white, had fair/poor self-reported health or had less formal education were more likely to report feeling better about their doctor. Among doctors, 26% anticipated documentation errors, and 44% thought patients would disagree with notes. After a year, 53% believed patient satisfaction increased, and 51% thought patients trusted them more. None reported ordering more tests or referrals. Despite concerns about errors, offending language or defensive practice, transparent notes overall did not harm the patient-doctor relationship. Rather, doctors and patients perceived relational benefits. Traditionally more vulnerable populations-non-white, those with poorer self-reported health and those with fewer years of formal education-may be particularly likely to feel better about their doctor after reading their notes. Further informing debate about OpenNotes, the findings suggest transparent records may improve patient satisfaction, trust and safety. Published by the BMJ Publishing Group Limited. For permission to use (where not already

29 CFR Appendices to Subpart L of... - Note

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 5 2010-07-01 2010-07-01 false Note Appendices to Subpart L of Part 1910 Labor Regulations... OCCUPATIONAL SAFETY AND HEALTH STANDARDS Fire Protection Pt. 1910, Subpt. L, Apps. Nt. Appendices to Subpart L of Part 1910—Note Note: The following appendices to subpart L, except appendix E, serve as...

Safety assessment of plant food supplements (PFS).

PubMed

van den Berg, Suzanne J P L; Serra-Majem, Lluis; Coppens, Patrick; Rietjens, Ivonne M C M

2011-12-01

Botanicals and botanical preparations, including plant food supplements (PFS), are widely used in Western diets. The growing use of PFS is accompanied by an increasing concern because the safety of these PFS is not generally assessed before they enter the market. Regulatory bodies have become more aware of this and are increasing their efforts to ensure the safety of PFS. The present review describes an overview of the general framework for the safety assessment of PFS, focusing on the different approaches currently in use to assess the safety of botanicals and/or botanical compounds, including their history of safe use, the tiered approach proposed by the European Food Safety Authority (EFSA), the Threshold of Toxicological Concern (TTC) and the Margin of Exposure (MOE) concept. Moreover, some examples of botanical compounds in PFS that may be of concern are discussed. Altogether, it is clear that "natural" does not equal "safe" and that PFS may contain compounds of concern at levels far above those found in the regular diet. In addition, the traditional use of a PFS compound as a herb or tea does not guarantee its safety when used as a supplement. This points at a need for stricter regulation and control of botanical containing products, especially given their expanding market volume.

Pure retroperitoneal natural orifice translumenal endoscopic surgery (NOTES) transvaginal nephrectomy using standard laparoscopic instruments: a safety and feasibility study in a porcine model.

PubMed

Wei, Dechao; Han, Yili; Li, Mingchuan; Wang, Yongxing; Chen, Yatong; Luo, Yong; Jiang, Yongguang

2016-06-11

Among the different organs used for NOTES (natural orifice translumenal endoscopic surgery) technique, the transvaginal approach may be the optimal choice because of a simple and secure closure of colpotomy site. Pure and hybrid NOTES transvaginal operations were routinely performed via transperitoneal access. In this study, we investigate the safety and feasibility of pure retroperitoneal natural orifice translumenal endoscopic surgery (NOTES) transvaginal nephrectomy using conventional laparoscopic techniques in a porcine model. Six female pigs, weighing an average of 30 kg, were used in this study. Under general anesthesia, pure retroperitoneal NOTES transvaginal nephrectomy was conducted using standard laparoscopic instruments. Posterolateral colpotomy was performed, and the incision was enlarged laterally using blunt dissection and pneumatic dilation. A single-port device was inserted to construct the operative channel. The retroperitoneal space was created using sharp and blunt dissection under endoscopic guidance up to the level of the kidney. Dissection and removal of the kidney were performed according to standard surgical procedure, and the colpotomy site was closed using interrupted sutures. The survival and complications were observed 1 week postoperatively. Our results showed that two cases failed because of peritoneal rupture. One case was successful, but required the assistance of an extra 5 mm laparoscopic trocar inserted in the flank. Three cases of pure retroperitoneal NOTES transvaginal nephrectomy were completed, and survived 1 week after the operation. In these three cases, no intra- or postoperative complications were observed. All findings confirmed the safety and feasibility of the retroperitoneal pure retroperitoneal NOTES transvaginal nephrectomy using standard laparoscopic instruments, which suggested the possibility of clinical application in human beings in the future.

Safety Assessment of Polyether Lanolins 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; Heldreth, Bart

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 39 polyether lanolin ingredients as used in cosmetics. These ingredients function mostly as hair conditioning agents, skin conditioning agent-emollients, and surfactant-emulsifying agents. The Panel reviewed available animal and clinical data, from previous CIR safety assessments of related ingredients and components. The similar structure, properties, functions, and uses of these ingredients enabled grouping them and using the available toxicological data to assess the safety of the entire group. The Panel concluded that these polyether lanolin ingredients are safe in the practices of use and concentration as given in this safety assessment.

Need for an "integrated safety assessment" of GMOs, linking food safety and environmental considerations.

PubMed

Haslberger, Alexander G

2006-05-03

Evidence for substantial environmental influences on health and food safety comes from work with environmental health indicators which show that agroenvironmental practices have direct and indirect effects on human health, concluding that "the quality of the environment influences the quality and safety of foods" [Fennema, O. Environ. Health Perspect. 1990, 86, 229-232). In the field of genetically modified organisms (GMOs), Codex principles have been established for the assessment of GM food safety and the Cartagena Protocol on Biosafety outlines international principles for an environmental assessment of living modified organisms. Both concepts also contain starting points for an assessment of health/food safety effects of GMOs in cases when the environment is involved in the chain of events that could lead to hazards. The environment can act as a route of unintentional entry of GMOs into the food supply, such as in the case of gene flow via pollen or seeds from GM crops, but the environment can also be involved in changes of GMO-induced agricultural practices with relevance for health/food safety. Examples for this include potential regional changes of pesticide uses and reduction in pesticide poisonings resulting from the use of Bt crops or influences on immune responses via cross-reactivity. Clearly, modern methods of biotechnology in breeding are involved in the reasons behind the rapid reduction of local varieties in agrodiversity, which constitute an identified hazard for food safety and food security. The health/food safety assessment of GM foods in cases when the environment is involved needs to be informed by data from environmental assessment. Such data might be especially important for hazard identification and exposure assessment. International organizations working in these areas will very likely be needed to initiate and enable cooperation between those institutions responsible for the different assessments, as well as for exchange and analysis of

Assessing safety climate in acute hospital settings: a systematic review of the adequacy of the psychometric properties of survey measurement tools.

PubMed

Alsalem, Gheed; Bowie, Paul; Morrison, Jillian

2018-05-10

The perceived importance of safety culture in improving patient safety and its impact on patient outcomes has led to a growing interest in the assessment of safety climate in healthcare organizations; however, the rigour with which safety climate tools were developed and psychometrically tested was shown to be variable. This paper aims to identify and review questionnaire studies designed to measure safety climate in acute hospital settings, in order to assess the adequacy of reported psychometric properties of identified tools. A systematic review of published empirical literature was undertaken to examine sample characteristics and instrument details including safety climate dimensions, origin and theoretical basis, and extent of psychometric evaluation (content validity, criterion validity, construct validity and internal reliability). Five questionnaire tools, designed for general evaluation of safety climate in acute hospital settings, were included. Detailed inspection revealed ambiguity around concepts of safety culture and climate, safety climate dimensions and the methodological rigour associated with the design of these measures. Standard reporting of the psychometric properties of developed questionnaires was variable, although evidence of an improving trend in the quality of the reported psychometric properties of studies was noted. Evidence of the theoretical underpinnings of climate tools was limited, while a lack of clarity in the relationship between safety culture and patient outcome measures still exists. Evidence of the adequacy of the psychometric development of safety climate questionnaire tools is still limited. Research is necessary to resolve the controversies in the definitions and dimensions of safety culture and climate in healthcare and identify related inconsistencies. More importance should be given to the appropriate validation of safety climate questionnaires before extending their usage in healthcare contexts different from those in

Safety Assessment of Chlorphenesin as Used in Cosmetics.

PubMed

Johnson, Wilbur; 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

2014-05-26

Chlorphenesin functions as a biocide in cosmetics and is used at concentrations up to 0.32% in rinse-off products and up to 0.3% in leave-on products. The Cosmetic Ingredient Review Expert Panel (Panel) noted that chlorphenesin was well absorbed when applied to the skin of rats; however, any safety concern was minimized because available data demonstrated an absence of toxicity. The Panel concluded that chlorphenesin is safe in the present practices of use and concentration. © The Author(s) 2014.

Safety assessment and detection methods of genetically modified organisms.

PubMed

Xu, Rong; Zheng, Zhe; Jiao, Guanglian

2014-01-01

Genetically modified organisms (GMOs), are gaining importance in agriculture as well as the production of food and feed. Along with the development of GMOs, health and food safety concerns have been raised. These concerns for these new GMOs make it necessary to set up strict system on food safety assessment of GMOs. The food safety assessment of GMOs, current development status of safety and precise transgenic technologies and GMOs detection have been discussed in this review. The recent patents about GMOs and their detection methods are also reviewed. This review can provide elementary introduction on how to assess and detect GMOs.

Safety huddles to proactively identify and address electronic health record safety

PubMed Central

Menon, Shailaja; Singh, Hardeep; Giardina, Traber D; Rayburn, William L; Davis, Brenda P; Russo, Elise M

2017-01-01

Objective: Methods to identify and study safety risks of electronic health records (EHRs) are underdeveloped and largely depend on limited end-user reports. “Safety huddles” have been found useful in creating a sense of collective situational awareness that increases an organization’s capacity to respond to safety concerns. We explored the use of safety huddles for identifying and learning about EHR-related safety concerns. Design: Data were obtained from daily safety huddle briefing notes recorded at a single midsized tertiary-care hospital in the United States over 1 year. Huddles were attended by key administrative, clinical, and information technology staff. We conducted a content analysis of huddle notes to identify what EHR-related safety concerns were discussed. We expanded a previously developed EHR-related error taxonomy to categorize types of EHR-related safety concerns recorded in the notes. Results: On review of daily huddle notes spanning 249 days, we identified 245 EHR-related safety concerns. For our analysis, we defined EHR technology to include a specific EHR functionality, an entire clinical software application, or the hardware system. Most concerns (41.6%) involved “EHR technology working incorrectly,” followed by 25.7% involving “EHR technology not working at all.” Concerns related to “EHR technology missing or absent” accounted for 16.7%, whereas 15.9% were linked to “user errors.” Conclusions: Safety huddles promoted discussion of several technology-related issues at the organization level and can serve as a promising technique to identify and address EHR-related safety concerns. Based on our findings, we recommend that health care organizations consider huddles as a strategy to promote understanding and improvement of EHR safety. PMID:28031286

Analysis of safety impacts of access management alternatives using the surrogate safety assessment model : final report.

DOT National Transportation Integrated Search

2017-06-01

The purpose of this study was to evaluate if the Surrogate Safety Assessment Model (SSAM) could be used to assess the safety of a highway segment or an intersection in terms of the number and type of conflicts and to compare the safety effects of mul...

Comparative safety assessment of plant-derived foods.

PubMed

Kok, E J; Keijer, J; Kleter, G A; Kuiper, H A

2008-02-01

The second generation of genetically modified (GM) plants that are moving towards the market are characterized by modifications that may be more complex and traits that more often are to the benefit of the consumer. These developments will have implications for the safety assessment of the resulting plant products. In part of the cases the same crop plant can, however, also be obtained by 'conventional' breeding strategies. The breeder will decide on a case-by-case basis what will be the best strategy to reach the set target and whether genetic modification will form part of this strategy. This article discusses important aspects of the safety assessment of complex products derived from newly bred plant varieties obtained by different breeding strategies. On the basis of this overview, we conclude that the current process of the safety evaluation of GM versus conventionally bred plants is not well balanced. GM varieties are elaborately assessed, yet at the same time other crop plants resulting from conventional breeding strategies may warrant further food safety assessment for the benefit of the consumer. We propose to develop a general screening frame for all newly developed plant varieties to select varieties that cannot, on the basis of scientific criteria, be considered as safe as plant varieties that are already on the market.

Initial development of a practical safety audit tool to assess fleet safety management practices.

PubMed

Mitchell, Rebecca; Friswell, Rena; Mooren, Lori

2012-07-01

Work-related vehicle crashes are a common cause of occupational injury. Yet, there are few studies that investigate management practices used for light vehicle fleets (i.e. vehicles less than 4.5 tonnes). One of the impediments to obtaining and sharing information on effective fleet safety management is the lack of an evidence-based, standardised measurement tool. This article describes the initial development of an audit tool to assess fleet safety management practices in light vehicle fleets. The audit tool was developed by triangulating information from a review of the literature on fleet safety management practices and from semi-structured interviews with 15 fleet managers and 21 fleet drivers. A preliminary useability assessment was conducted with 5 organisations. The audit tool assesses the management of fleet safety against five core categories: (1) management, systems and processes; (2) monitoring and assessment; (3) employee recruitment, training and education; (4) vehicle technology, selection and maintenance; and (5) vehicle journeys. Each of these core categories has between 1 and 3 sub-categories. Organisations are rated at one of 4 levels on each sub-category. The fleet safety management audit tool is designed to identify the extent to which fleet safety is managed in an organisation against best practice. It is intended that the audit tool be used to conduct audits within an organisation to provide an indicator of progress in managing fleet safety and to consistently benchmark performance against other organisations. Application of the tool by fleet safety researchers is now needed to inform its further development and refinement and to permit psychometric evaluation. Copyright © 2012 Elsevier Ltd. All rights reserved.

Animal-Free Chemical Safety Assessment

PubMed Central

Loizou, George D.

2016-01-01

The exponential growth of the Internet of Things and the global popularity and remarkable decline in cost of the mobile phone is driving the digital transformation of medical practice. The rapidly maturing digital, non-medical world of mobile (wireless) devices, cloud computing and social networking is coalescing with the emerging digital medical world of omics data, biosensors and advanced imaging which offers the increasingly realistic prospect of personalized medicine. Described as a potential “seismic” shift from the current “healthcare” model to a “wellness” paradigm that is predictive, preventative, personalized and participatory, this change is based on the development of increasingly sophisticated biosensors which can track and measure key biochemical variables in people. Additional key drivers in this shift are metabolomic and proteomic signatures, which are increasingly being reported as pre-symptomatic, diagnostic and prognostic of toxicity and disease. These advancements also have profound implications for toxicological evaluation and safety assessment of pharmaceuticals and environmental chemicals. An approach based primarily on human in vivo and high-throughput in vitro human cell-line data is a distinct possibility. This would transform current chemical safety assessment practice which operates in a human “data poor” to a human “data rich” environment. This could also lead to a seismic shift from the current animal-based to an animal-free chemical safety assessment paradigm. PMID:27493630

Assessing patient safety culture in Tunisian operating rooms: A multicenter study.

PubMed

Mallouli, Manel; Tlili, Mohamed Ayoub; Aouicha, Wiem; Ben Rejeb, Mohamed; Zedini, Chekib; Salwa, Amrani; Mtiraoui, Ali; Ben Dhiab, Mohamed; Ajmi, Thouraya

2017-04-01

To assess the patient safety culture (PSC) in operating rooms (ORs) and to determine influencing factors. A cross-sectional descriptive multicenter study which was conducted over a period of 7 months (October 2014-April 2015) using the French validated version of the Hospital Survey On Patient Safety Culture questionnaire. Of the note, 15 ORs of public and private healthcare institutions. In total, there were 368 participants including surgeons, anesthesiologists, surgical and anesthesia technicians, nurses and caregivers, divided into 316 professionals exercising in public sector and 52 working in private one. A self-administrated questionnaire investigating 10 dimensions of PSC (including 45 items), two items examining the staff perception of patient safety quality and reporting events, and five items regarding demographic characteristics of respondents. The participation rate in the study was 70.8%. All 10 dimensions were to be improved. The overall perception of patient safety had a score of 34.9%. The dimension that had the lowest score (20.5%) was the non-punitive response to error, and the one that had the highest score (41.67%) was teamwork in the ORs. Three dimensions were developed in private sector, and none in public hospitals. This study showed that the level of the PSC needs to be improved not only in public hospitals but also in private ones. The obtained results highlight the importance of implementing quality management systems and developing PSC. © 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

Safety assessment for hair-spray resins: risk assessment based on rodent inhalation studies.

PubMed

Carthew, Philip; Griffiths, Heather; Keech, Stephen; Hartop, Peter

2002-04-01

The methods involved in the safety assessment of resins used in hair-spray products have received little peer review, or debate in the published literature, despite their widespread use, in both hairdressing salons and the home. The safety assessment for these resins currently involves determining the type of lung pathology that can be caused in animal inhalation exposure studies, and establishing the no-observable-effect level (NOEL) for these pathologies. The likely human consumer exposure is determined by techniques that model the simulated exposure under "in use" conditions. From these values it is then possible to derive the likely safety factors for human exposure. An important part of this process would be to recognize the intrinsic differences between rodents and humans in terms of the respiratory doses that each species experiences during inhalation exposures, for the purpose of the safety assessment. Interspecies scaling factors become necessary when comparing the exposure doses experienced by rats, compared to humans, because of basic differences between species in lung clearance rates and the alveolar area in the lungs. The rodent inhalation data and modeled human exposure to Resin 6965, a resin polymer that is based on vinyl acetate, has been used to calculate the safety factor for human consumer exposure to this resin, under a range of "in use" exposure conditions. The use of this safety assessment process clearly demonstrates that Resin 6965 is acceptable for human consumer exposure under the conditions considered in this risk assessment.

Pharmacological mechanism-based drug safety assessment and prediction.

PubMed

Abernethy, D R; Woodcock, J; Lesko, L J

2011-06-01

Advances in cheminformatics, bioinformatics, and pharmacology in the context of biological systems are now at a point that these tools can be applied to mechanism-based drug safety assessment and prediction. The development of such predictive tools at the US Food and Drug Administration (FDA) will complement ongoing efforts in drug safety that are focused on spontaneous adverse event reporting and active surveillance to monitor drug safety. This effort will require the active collaboration of scientists in the pharmaceutical industry, academe, and the National Institutes of Health, as well as those at the FDA, to reach its full potential. Here, we describe the approaches and goals for the mechanism-based drug safety assessment and prediction program.

LANL Safety Conscious Work Environment (SCWE) Self-Assessment

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

Hargis, Barbara C.

2014-01-29

On December 21, 2012 Secretary of Energy Chu transmitted to the Defense Nuclear Facilities Safety Board (DNFSB) revised commitments on the implementation plan for Safety Culture at the Waste Treatment and Immobilization Plant. Action 2-5 was revised to require contractors and federal organizations to complete Safety Conscious Work Environment (SCWE) selfassessments and provide reports to the appropriate U.S. Department of Energy (DOE) - Headquarters Program Office by September 2013. Los Alamos National Laboratory (LANL) planned and conducted a Safety Conscious Work Environment (SCWE) Self-Assessment over the time period July through August, 2013 in accordance with the SCWE Self-Assessment Guidance providedmore » by DOE. Significant field work was conducted over the 2-week period August 5-16, 2013. The purpose of the self-assessment was to evaluate whether programs and processes associated with a SCWE are in place and whether they are effective in supporting and promoting a SCWE.« less

Recommendations of the Oligonucleotide Safety Working Group's Formulated Oligonucleotide Subcommittee for the Safety Assessment of Formulated Oligonucleotide-Based Therapeutics.

PubMed

Marlowe, Jennifer L; Akopian, Violetta; Karmali, Priya; Kornbrust, Douglas; Lockridge, Jennifer; Semple, Sean

2017-08-01

The use of lipid formulations has greatly improved the ability to effectively deliver oligonucleotides and has been instrumental in the rapid expansion of therapeutic development programs using oligonucleotide drugs. However, the development of such complex multicomponent therapeutics requires the implementation of unique, scientifically sound approaches to the nonclinical development of these drugs, based upon a hybrid of knowledge and experiences drawn from small molecule, protein, and oligonucleotide therapeutic drug development. The relative paucity of directly applicable regulatory guidance documents for oligonucleotide therapeutics in general has resulted in the generation of multiple white papers from oligonucleotide drug development experts and members of the Oligonucleotide Safety Working Group (OSWG). The members of the Formulated Oligonucleotide Subcommittee of the OSWG have utilized their collective experience working with a variety of formulations and their associated oligonucleotide payloads, as well as their insights into regulatory considerations and expectations, to generate a series of consensus recommendations for the pharmacokinetic characterization and nonclinical safety assessment of this unique class of therapeutics. It should be noted that the focus of Subcommittee discussions was on lipid nanoparticle and other types of particulate formulations of therapeutic oligonucleotides and not on conjugates or other types of modifications of oligonucleotide structure intended to facilitate delivery.

The IDEA Assessment Tool: Assessing the Reporting, Diagnostic Reasoning, and Decision-Making Skills Demonstrated in Medical Students' Hospital Admission Notes.

PubMed

Baker, Elizabeth A; Ledford, Cynthia H; Fogg, Louis; Way, David P; Park, Yoon Soo

2015-01-01

Construct: Clinical skills are used in the care of patients, including reporting, diagnostic reasoning, and decision-making skills. Written comprehensive new patient admission notes (H&Ps) are a ubiquitous part of student education but are underutilized in the assessment of clinical skills. The interpretive summary, differential diagnosis, explanation of reasoning, and alternatives (IDEA) assessment tool was developed to assess students' clinical skills using written comprehensive new patient admission notes. The validity evidence for assessment of clinical skills using clinical documentation following authentic patient encounters has not been well documented. Diagnostic justification tools and postencounter notes are described in the literature (1,2) but are based on standardized patient encounters. To our knowledge, the IDEA assessment tool is the first published tool that uses medical students' H&Ps to rate students' clinical skills. The IDEA assessment tool is a 15-item instrument that asks evaluators to rate students' reporting, diagnostic reasoning, and decision-making skills based on medical students' new patient admission notes. This study presents validity evidence in support of the IDEA assessment tool using Messick's unified framework, including content (theoretical framework), response process (interrater reliability), internal structure (factor analysis and internal-consistency reliability), and relationship to other variables. Validity evidence is based on results from four studies conducted between 2010 and 2013. First, the factor analysis (2010, n = 216) yielded a three-factor solution, measuring patient story, IDEA, and completeness, with reliabilities of .79, .88, and .79, respectively. Second, an initial interrater reliability study (2010) involving two raters demonstrated fair to moderate consensus (κ = .21-.56, ρ =.42-.79). Third, a second interrater reliability study (2011) with 22 trained raters also demonstrated fair to moderate agreement

Safety management system needs assessment.

DOT National Transportation Integrated Search

2016-04-01

The safety of the traveling public is critical as each year there are approximately 200 highway fatalities in Nebraska and numerous crash injuries. The objective of this research was to conduct a needs assessment to identify the requirements of a sta...

Methodology to assess clinical liver safety data.

PubMed

Merz, Michael; Lee, Kwan R; Kullak-Ublick, Gerd A; Brueckner, Andreas; Watkins, Paul B

2014-11-01

Analysis of liver safety data has to be multivariate by nature and needs to take into account time dependency of observations. Current standard tools for liver safety assessment such as summary tables, individual data listings, and narratives address these requirements to a limited extent only. Using graphics in the context of a systematic workflow including predefined graph templates is a valuable addition to standard instruments, helping to ensure completeness of evaluation, and supporting both hypothesis generation and testing. Employing graphical workflows interactively allows analysis in a team-based setting and facilitates identification of the most suitable graphics for publishing and regulatory reporting. Another important tool is statistical outlier detection, accounting for the fact that for assessment of Drug-Induced Liver Injury, identification and thorough evaluation of extreme values has much more relevance than measures of central tendency in the data. Taken together, systematical graphical data exploration and statistical outlier detection may have the potential to significantly improve assessment and interpretation of clinical liver safety data. A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials.

Upholding science in health, safety and environmental risk assessments and regulations.

PubMed

Aschner, Michael; Autrup, Herman N; Berry, Sir Colin L; Boobis, Alan R; Cohen, Samuel M; Creppy, Edmond E; Dekant, Wolfgang; Doull, John; Galli, Corrado L; Goodman, Jay I; Gori, Gio B; Greim, Helmut A; Joudrier, Philippe; Kaminski, Norbert E; Klaassen, Curtis D; Klaunig, James E; Lotti, Marcello; Marquardt, Hans W J; Pelkonen, Olavi; Sipes, I Glenn; Wallace, Kendall B; Yamazaki, Hiroshi

2016-09-14

A public appeal has been advanced by a large group of scientists, concerned that science has been misused in attempting to quantify and regulate unmeasurable hazards and risks. 1 The appeal recalls that science is unable to evaluate hazards that cannot be measured, and that science in such cases should not be invoked to justify risk assessments in health, safety and environmental regulations. The appeal also notes that most national and international statutes delineating the discretion of regulators are ambiguous about what rules of evidence ought to apply. Those statutes should be revised to ensure that the evidence for regulatory action is grounded on the standards of the scientific method, whenever feasible. When independent scientific evidence is not possible, policies and regulations should be informed by publicly debated trade-offs between socially desirable uses and social perceptions of affordable precaution. This article explores the premises, implications and actions supporting the appeal and its objectives. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

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.

A novel safety assessment strategy applied to non-selective extracts.

PubMed

Koster, Sander; Leeman, Winfried; Verheij, Elwin; Dutman, Ellen; van Stee, Leo; Nielsen, Lene Munch; Ronsmans, Stefan; Noteborn, Hub; Krul, Lisette

2015-06-01

A main challenge in food safety research is to demonstrate that processing of foodstuffs does not lead to the formation of substances for which the safety upon consumption might be questioned. This is especially so since food is a complex matrix in which the analytical detection of substances, and consequent risk assessment thereof, is difficult to determine. Here, a pragmatic novel safety assessment strategy is applied to the production of non-selective extracts (NSEs), used for different purposes in food such as for colouring purposes, which are complex food mixtures prepared from reference juices. The Complex Mixture Safety Assessment Strategy (CoMSAS) is an exposure driven approach enabling to efficiently assess the safety of the NSE by focussing on newly formed substances or substances that may increase in exposure during the processing of the NSE. CoMSAS enables to distinguish toxicologically relevant from toxicologically less relevant substances, when related to their respective levels of exposure. This will reduce the amount of work needed for identification, characterisation and safety assessment of unknown substances detected at low concentration, without the need for toxicity testing using animal studies. In this paper, the CoMSAS approach has been applied for elderberry and pumpkin NSEs used for food colouring purposes. Copyright © 2015 Elsevier Ltd. All rights reserved.

Mine safety assessment using gray relational analysis and bow tie model

PubMed Central

2018-01-01

Mine safety assessment is a precondition for ensuring orderly and safety in production. The main purpose of this study was to prevent mine accidents more effectively by proposing a composite risk analysis model. First, the weights of the assessment indicators were determined by the revised integrated weight method, in which the objective weights were determined by a variation coefficient method and the subjective weights determined by the Delphi method. A new formula was then adopted to calculate the integrated weights based on the subjective and objective weights. Second, after the assessment indicator weights were determined, gray relational analysis was used to evaluate the safety of mine enterprises. Mine enterprise safety was ranked according to the gray relational degree, and weak links of mine safety practices identified based on gray relational analysis. Third, to validate the revised integrated weight method adopted in the process of gray relational analysis, the fuzzy evaluation method was used to the safety assessment of mine enterprises. Fourth, for first time, bow tie model was adopted to identify the causes and consequences of weak links and allow corresponding safety measures to be taken to guarantee the mine’s safe production. A case study of mine safety assessment was presented to demonstrate the effectiveness and rationality of the proposed composite risk analysis model, which can be applied to other related industries for safety evaluation. PMID:29561875

The practice of pre-marketing safety assessment in drug development.

PubMed

Chuang-Stein, Christy; Xia, H Amy

2013-01-01

The last 15 years have seen a substantial increase in efforts devoted to safety assessment by statisticians in the pharmaceutical industry. While some of these efforts were driven by regulations and public demand for safer products, much of the motivation came from the realization that there is a strong need for a systematic approach to safety planning, evaluation, and reporting at the program level throughout the drug development life cycle. An efficient process can help us identify safety signals early and afford us the opportunity to develop effective risk minimization plan early in the development cycle. This awareness has led many pharmaceutical sponsors to set up internal systems and structures to effectively conduct safety assessment at all levels (patient, study, and program). In addition to process, tools have emerged that are designed to enhance data review and pattern recognition. In this paper, we describe advancements in the practice of safety assessment during the premarketing phase of drug development. In particular, we share examples of safety assessment practice at our respective companies, some of which are based on recommendations from industry-initiated working groups on best practice in recent years.

Quality of outpatient clinical notes: a stakeholder definition derived through qualitative research.

PubMed

Hanson, Janice L; Stephens, Mark B; Pangaro, Louis N; Gimbel, Ronald W

2012-11-19

There are no empirically-grounded criteria or tools to define or benchmark the quality of outpatient clinical documentation. Outpatient clinical notes document care, communicate treatment plans and support patient safety, medical education, medico-legal investigations and reimbursement. Accurately describing and assessing quality of clinical documentation is a necessary improvement in an increasingly team-based healthcare delivery system. In this paper we describe the quality of outpatient clinical notes from the perspective of multiple stakeholders. Using purposeful sampling for maximum diversity, we conducted focus groups and individual interviews with clinicians, nursing and ancillary staff, patients, and healthcare administrators at six federal health care facilities between 2009 and 2011. All sessions were audio-recorded, transcribed and qualitatively analyzed using open, axial and selective coding. The 163 participants included 61 clinicians, 52 nurse/ancillary staff, 31 patients and 19 administrative staff. Three organizing themes emerged: 1) characteristics of quality in clinical notes, 2) desired elements within the clinical notes and 3) system supports to improve the quality of clinical notes. We identified 11 codes to describe characteristics of clinical notes, 20 codes to describe desired elements in quality clinical notes and 11 codes to describe clinical system elements that support quality when writing clinical notes. While there was substantial overlap between the aspects of quality described by the four stakeholder groups, only clinicians and administrators identified ease of translation into billing codes as an important characteristic of a quality note. Only patients rated prioritization of their medical problems as an aspect of quality. Nurses included care and education delivered to the patient, information added by the patient, interdisciplinary information, and infection alerts as important content. Perspectives of these four stakeholder

Improved patient notes from medical students during web-based teaching using faculty-calibrated peer review and self-assessment.

PubMed

McCarty, Teresita; Parkes, Marie V; Anderson, Teresa T; Mines, Jan; Skipper, Betty J; Grebosky, James

2005-10-01

This study examines the effectiveness of Calibrated Peer Review (CPR), a Web-based writing development program, to teach and assess medical students' patient note-writing skills in a standardized fashion. At the end of the clerkship year, 67 medical students were divided into three groups, introduced to CPR, and instructed in patient note-writing. Students then wrote notes for three clinical cases, presented in different order to each group. After training on faculty-calibrated standards, students evaluated their peers' notes and their own notes. Trained faculty, blinded to author, order, and group, also graded student notes. Faculty gave lower scores than students, but both groups found students' scores improved significantly from the first to the third note written. Student-written patient notes improved in quality while using CPR. The program uses approaches valued in medicine (accurate peer review and self-reflection) to enhance performance.

Bayesian-network-based safety risk assessment for steel construction projects.

PubMed

Leu, Sou-Sen; Chang, Ching-Miao

2013-05-01

There are four primary accident types at steel building construction (SC) projects: falls (tumbles), object falls, object collapse, and electrocution. Several systematic safety risk assessment approaches, such as fault tree analysis (FTA) and failure mode and effect criticality analysis (FMECA), have been used to evaluate safety risks at SC projects. However, these traditional methods ineffectively address dependencies among safety factors at various levels that fail to provide early warnings to prevent occupational accidents. To overcome the limitations of traditional approaches, this study addresses the development of a safety risk-assessment model for SC projects by establishing the Bayesian networks (BN) based on fault tree (FT) transformation. The BN-based safety risk-assessment model was validated against the safety inspection records of six SC building projects and nine projects in which site accidents occurred. The ranks of posterior probabilities from the BN model were highly consistent with the accidents that occurred at each project site. The model accurately provides site safety-management abilities by calculating the probabilities of safety risks and further analyzing the causes of accidents based on their relationships in BNs. In practice, based on the analysis of accident risks and significant safety factors, proper preventive safety management strategies can be established to reduce the occurrence of accidents on SC sites. Copyright © 2013 Elsevier Ltd. All rights reserved.

Extended time-to-collision measures for road traffic safety assessment.

PubMed

Minderhoud, M M; Bovy, P H

2001-01-01

This article describes two new safety indicators based on the time-to-collision notion suitable for comparative road traffic safety analyses. Such safety indicators can be applied in the comparison of a do-nothing case with an adapted situation, e.g. the introduction of intelligent driver support systems. In contrast to the classical time-to-collision value, measured at a cross section, the improved safety indicators use vehicle trajectories collected over a specific time horizon for a certain roadway segment to calculate the overall safety indicator value. Vehicle-specific indicator values as well as safety-critical probabilities can easily be determined from the developed safety measures. Application of the derived safety indicators is demonstrated for the assessment of the potential safety impacts of driver support systems from which it appears that some Autonomous Intelligent Cruise Control (AICC) designs are more safety-critical than the reference case without these systems. It is suggested that the indicator threshold value to be applied in the safety assessment has to be adapted when advanced AICC-systems with safe characteristics are introduced.

Safety analysis and review system (SARS) assessment report

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

Browne, E.T.

1981-03-01

Under DOE Order 5481.1, Safety Analysis and Review System for DOE Operations, safety analyses are required for DOE projects in order to ensure that: (1) potential hazards are systematically identified; (2) potential impacts are analyzed; (3) reasonable measures have been taken to eliminate, control, or mitigate the hazards; and (4) there is documented management authorization of the DOE operation based on an objective assessment of the adequacy of the safety analysis. This report is intended to provide the DOE Office of Plans and Technology Assessment (OPTA) with an independent evaluation of the adequacy of the ongoing safety analysis effort. Asmore » part of this effort, a number of site visits and interviews were conducted, and FE SARS documents were reviewed. The latter included SARS Implementation Plans for a number of FE field offices, as well as safety analysis reports completed for certain FE operations. This report summarizes SARS related efforts at the DOE field offices visited and evaluates the extent to which they fulfill the requirements of DOE 5481.1.« less

Use of the Home Safety Self-Assessment Tool (HSSAT) within Community Health Education to Improve Home Safety.

PubMed

Horowitz, Beverly P; Almonte, Tiffany; Vasil, Andrea

2016-10-01

This exploratory research examined the benefits of a health education program utilizing the Home Safety Self-Assessment Tool (HSSAT) to increase perceived knowledge of home safety, recognition of unsafe activities, ability to safely perform activities, and develop home safety plans of 47 older adults. Focus groups in two senior centers explored social workers' perspectives on use of the HSSAT in community practice. Results for the health education program found significant differences between reported knowledge of home safety (p = .02), ability to recognize unsafe activities (p = .01), safely perform activities (p = .04), and develop a safety plan (p = .002). Social workers identified home safety as a major concern and the HSSAT a promising assessment tool. Research has implications for reducing environmental fall risks.

Comprehensive safety management and assessment at rugby football competitions.

PubMed

Tajima, T; Chosa, E; Kawahara, K; Nakamura, Y; Yoshikawa, D; Yamaguchi, N; Kashiwagi, T

2014-11-01

The present study aims to improve medical systems by designing objective safety assessment criteria for rugby competitions. We evaluated 195 competitions between 2002 and 2011 using an original safety scale comprising the following sections: 1) competence of staff such as referees, medical attendants and match day doctor; 2) environment such as weather, wet bulb globe temperature and field conditions; and 3) emergency medical care systems at the competitions. Each section was subdivided into groups A, B and C according to good, normal or fair degrees of safety determined by combinations of the results.Overall safety was assessed as A, B and C for 110, 78 and 7 competitions, respectively. The assessments of individual major factors were mostly favorable for staff, but the environment and medical care systems were assessed as C in 25 and 70, respectively, of the 195 competitions. Medical management involves not having a match day doctor, but also comprehensive management including preventive factors and responses from the staff, environment and medical-care systems. 6 cases of severe injuries and accidents occurred between 2002 and 2011, which were observed in Grade A competition. These cases revealed better prognosis without obvious impairment, thus confirming the value of the present assessment scale. © Georg Thieme Verlag KG Stuttgart · New York.

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.

Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 1 - guideword applicability and method description.

PubMed

Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

2008-12-15

Layout planning plays a key role in the inherent safety performance of process plants since this design feature controls the possibility of accidental chain-events and the magnitude of possible consequences. A lack of suitable methods to promote the effective implementation of inherent safety in layout design calls for the development of new techniques and methods. In the present paper, a safety assessment approach suitable for layout design in the critical early phase is proposed. The concept of inherent safety is implemented within this safety assessment; the approach is based on an integrated assessment of inherent safety guideword applicability within the constraints typically present in layout design. Application of these guidewords is evaluated along with unit hazards and control devices to quantitatively map the safety performance of different layout options. Moreover, the economic aspects related to safety and inherent safety are evaluated by the method. Specific sub-indices are developed within the integrated safety assessment system to analyze and quantify the hazard related to domino effects. The proposed approach is quick in application, auditable and shares a common framework applicable in other phases of the design lifecycle (e.g. process design). The present work is divided in two parts: Part 1 (current paper) presents the application of inherent safety guidelines in layout design and the index method for safety assessment; Part 2 (accompanying paper) describes the domino hazard sub-index and demonstrates the proposed approach with a case study, thus evidencing the introduction of inherent safety features in layout design.

49 CFR Appendix B to Part 236 - Risk Assessment Criteria

Code of Federal Regulations, 2010 CFR

2010-10-01

... results of the application of safety design principles as noted in Appendix C to this part. The MTTHE is... fault/failure analysis must be based on the assessment of the design and implementation of all safety... associated device drivers, as well as historical performance data, analytical methods and experimental safety...

49 CFR Appendix B to Part 236 - Risk Assessment Criteria

Code of Federal Regulations, 2013 CFR

2013-10-01

... results of the application of safety design principles as noted in Appendix C to this part. The MTTHE is... fault/failure analysis must be based on the assessment of the design and implementation of all safety... associated device drivers, as well as historical performance data, analytical methods and experimental safety...

Assessment of methods used to determine the safety of the topical insect repellent N,N-diethyl-m-toluamide (DEET).

PubMed

Chen-Hussey, Vanessa; Behrens, Ron; Logan, James G

2014-06-03

N,N-diethyl-m-toluamide (DEET) has been registered for commercial use as an insect repellent for over five decades, and is used widely across the world. Concerns over the safety of DEET first emerged during the 1980s after reports of encephalopathy following DEET exposure, particularly in children. However, the role of DEET in either the illness or deaths was and remains purely speculative. In response to these cases a number of reviews and investigations of DEET safety were carried out. Here we examine the methods used and information available to determine the safety of DEET in humans. Animal testing, observational studies and intervention trials have found no evidence of severe adverse events associated with recommended DEET use. Minor adverse effects noted in animal trials were associated with very large doses and were not replicated between different test species. The safety surveillance from extensive humans use reveals no association with severe adverse events. This review compares the toxicity assessment using three different models to define the risk assessment and safety threshold for DEET use in humans and discusses the clinical consequences of the thresholds derived from the models.The theoretical risks associated with wearing an insect repellent should be weighed against the reduction or prevention of the risk of fatal or debilitating diseases including malaria, dengue, yellow fever and filariasis. With over 48 million European residents travelling to regions where vector borne diseases are a threat in 2009, restricting the concentration of DEET containing repellents to 15% or less, as modelled in the 2010 EU directive, is likely to result in extensive sub-therapeutic activity where repellents are infrequently applied. Future European travellers, as a consequence of inadequate personal protection, could potentially be at increased risk of vector borne diseases. Risk assessments of repellents should take these factors into account when setting safe

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.

Processes of technology assessment: The National Transportation Safety Board

NASA Technical Reports Server (NTRS)

Weiss, E.

1972-01-01

The functions and operations of the Safety Board as related to technology assessment are described, and a brief history of the Safety Board is given. Recommendations made for safety in all areas of transportation and the actions taken are listed. Although accident investigation is an important aspect of NTSB's activity, it is felt that the greatest contribution is in pressing for development of better accident prevention programs. Efforts of the Safety Board in changing transportation technology to improve safety and prevent accidents are illustrated.

Australian oral health case notes: assessment of forensic relevance and adherence to recording guidelines.

PubMed

Stow, L; James, H; Richards, L

2016-06-01

Dental case notes record clinical diagnoses and treatments, as well as providing continuity of patient care. They are also used for dento-legal litigation and forensic purposes. Maintaining accurate and comprehensive dental patient records is a dental worker's ethical and legal obligation. Australian registered specialist forensic odontologists were surveyed to determine the relevance of recorded case note items for dental identification. A dental case notes sample was assessed for adherence with odontologist nominated forensic value and compiled professional record keeping guidelines of forensic relevance. Frequency of item recording, confidence interval, examiner agreement and statistical significance were determined. Broad agreement existed between forensic odontologists as to which recorded dental items have most forensic relevance. Inclusion frequency of these items in sampled case notes varied widely (e.g. single area radiographic view present in 75%, CI = 65.65-82.50; completed odontogram in 56%, CI = 46.23-65.33). Recording of information specified by professional record keeping guidelines also varied, although overall inclusion was higher than for forensically desired items (e.g. patient's full name in 99%, CI = 94.01 - >99.99; named treating practitioner in 23%, CI = 15.78-32.31). Many sampled dental case notes lacked details identified as being valuable by forensic specialists and as specified by professional record keeping guidelines. © 2016 Australian Dental Association.

Risk Assessment for NOTES

DTIC Science & Technology

1991-09-01

this is probably a low risk. Risks with Fuel Transfer (5) If a pulse occurs as fuel is being dispensed, say into a lawn mower , and the fueling nozzle is...occur near combustible materials or vapors, such as gasoline fumes. WARNING: As a safety precaution, the refueling of lawn mowers or other power

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.

Safety assessment methodology in management of spent sealed sources.

PubMed

Mahmoud, Narmine Salah

2005-02-14

Environmental hazards can be caused from radioactive waste after their disposal. It was therefore important that safety assessment methodologies be developed and established to study and estimate the possible hazards, and institute certain safety methodologies that lead and prevent the evolution of these hazards. Spent sealed sources are specific type of radioactive waste. According to IAEA definition, spent sealed sources are unused sources because of activity decay, damage, misuse, loss, or theft. Accidental exposure of humans from spent sealed sources can occur at the moment they become spent and before their disposal. Because of that reason, safety assessment methodologies were tailored to suit the management of spent sealed sources. To provide understanding and confidence of this study, validation analysis was undertaken by considering the scenario of an accident that occurred in Egypt, June 2000 (the Meet-Halfa accident from an iridium-192 source). The text of this work includes consideration related to the safety assessment approaches of spent sealed sources which constitutes assessment context, processes leading an active source to be spent, accident scenarios, mathematical models for dose calculations, and radiological consequences and regulatory criteria. The text also includes a validation study, which was carried out by evaluating a theoretical scenario compared to the real scenario of Meet-Halfa accident depending on the clinical assessment of affected individuals.

76 FR 74723 - New Car Assessment Program (NCAP); Safety Labeling

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-01

... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Part 575 [Docket No. NHTSA 2010-0025] RIN 2127-AK51 New Car Assessment Program (NCAP); Safety Labeling AGENCY: National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT). ACTION...

High-Throughput Toxicity Testing: New Strategies for Assessing Chemical Safety

EPA Science Inventory

In recent years, the food industry has made progress in improving safety testing methods focused on microbial contaminants in order to promote food safety. However, food industry toxicologists must also assess the safety of food-relevant chemicals including pesticides, direct add...

24 CFR 232.525 - Note and security form.

Code of Federal Regulations, 2011 CFR

2011-04-01

... MORTGAGE INSURANCE FOR NURSING HOMES, INTERMEDIATE CARE FACILITIES, BOARD AND CARE HOMES, AND ASSISTED... Fire Safety Equipment Eligible Security Instruments § 232.525 Note and security form. The lender shall...

Assessment of Safety Standards for Automotive Electronic Control Systems

DOT National Transportation Integrated Search

2016-06-01

This report summarizes the results of a study that assessed and compared six industry and government safety standards relevant to the safety and reliability of automotive electronic control systems. These standards include ISO 26262 (Road Vehicles - ...

Why the Eurocontrol Safety Regulation Commission Policy on Safety Nets and Risk Assessment is Wrong

NASA Astrophysics Data System (ADS)

Brooker, Peter

2004-05-01

Current Eurocontrol Safety Regulation Commission (SRC) policy says that the Air Traffic Management (ATM) system (including safety minima) must be demonstrated through risk assessments to meet the Target Level of Safety (TLS) without needing to take safety nets (such as Short Term Conflict Alert) into account. This policy is wrong. The policy is invalid because it does not build rationally and consistently from ATM's firm foundations of TLS and hazard analysis. The policy is bad because it would tend to retard safety improvements. Safety net policy must rest on a clear and rational treatment of integrated ATM system safety defences. A new safety net policy, appropriate to safe ATM system improvements, is needed, which recognizes that safety nets are an integrated part of ATM system defences. The effects of safety nets in reducing deaths from mid-air collisions should be fully included in hazard analysis and safety audits in the context of the TLS for total system design.

Safety Sufficiency for NextGen: Assessment of Selected Existing Safety Methods, Tools, Processes, and Regulations

NASA Technical Reports Server (NTRS)

Xu, Xidong; Ulrey, Mike L.; Brown, John A.; Mast, James; Lapis, Mary B.

2013-01-01

NextGen is a complex socio-technical system and, in many ways, it is expected to be more complex than the current system. It is vital to assess the safety impact of the NextGen elements (technologies, systems, and procedures) in a rigorous and systematic way and to ensure that they do not compromise safety. In this study, the NextGen elements in the form of Operational Improvements (OIs), Enablers, Research Activities, Development Activities, and Policy Issues were identified. The overall hazard situation in NextGen was outlined; a high-level hazard analysis was conducted with respect to multiple elements in a representative NextGen OI known as OI-0349 (Automation Support for Separation Management); and the hazards resulting from the highly dynamic complexity involved in an OI-0349 scenario were illustrated. A selected but representative set of the existing safety methods, tools, processes, and regulations was then reviewed and analyzed regarding whether they are sufficient to assess safety in the elements of that OI and ensure that safety will not be compromised and whether they might incur intolerably high costs.

Measuring Best Practices for Workplace Safety, Health, and Well-Being: The Workplace Integrated Safety and Health Assessment.

PubMed

Sorensen, Glorian; Sparer, Emily; Williams, Jessica A R; Gundersen, Daniel; Boden, Leslie I; Dennerlein, Jack T; Hashimoto, Dean; Katz, Jeffrey N; McLellan, Deborah L; Okechukwu, Cassandra A; Pronk, Nicolaas P; Revette, Anna; Wagner, Gregory R

2018-05-01

To present a measure of effective workplace organizational policies, programs, and practices that focuses on working conditions and organizational facilitators of worker safety, health and well-being: the workplace integrated safety and health (WISH) assessment. Development of this assessment used an iterative process involving a modified Delphi method, extensive literature reviews, and systematic cognitive testing. The assessment measures six core constructs identified as central to best practices for protecting and promoting worker safety, health and well-being: leadership commitment; participation; policies, programs, and practices that foster supportive working conditions; comprehensive and collaborative strategies; adherence to federal and state regulations and ethical norms; and data-driven change. The WISH Assessment holds promise as a tool that may inform organizational priority setting and guide research around causal pathways influencing implementation and outcomes related to these approaches.

NASA Aviation Safety Program Systems Analysis/Program Assessment Metrics Review

NASA Technical Reports Server (NTRS)

Louis, Garrick E.; Anderson, Katherine; Ahmad, Tisan; Bouabid, Ali; Siriwardana, Maya; Guilbaud, Patrick

2003-01-01

The goal of this project is to evaluate the metrics and processes used by NASA's Aviation Safety Program in assessing technologies that contribute to NASA's aviation safety goals. There were three objectives for reaching this goal. First, NASA's main objectives for aviation safety were documented and their consistency was checked against the main objectives of the Aviation Safety Program. Next, the metrics used for technology investment by the Program Assessment function of AvSP were evaluated. Finally, other metrics that could be used by the Program Assessment Team (PAT) were identified and evaluated. This investigation revealed that the objectives are in fact consistent across organizational levels at NASA and with the FAA. Some of the major issues discussed in this study which should be further investigated, are the removal of the Cost and Return-on-Investment metrics, the lack of the metrics to measure the balance of investment and technology, the interdependencies between some of the metric risk driver categories, and the conflict between 'fatal accident rate' and 'accident rate' in the language of the Aviation Safety goal as stated in different sources.

Research notes : are safety corridors really safe? Evaluation of the corridor safety improvement program.

DOT National Transportation Integrated Search

1998-08-26

High accident frequencies on Oregons highway corridors are of concern to the Oregon Department of Transportation (ODOT). : ODOT adopted the Corridor Safety Improvement Program as part of an overall program of safety improvements using federal and ...

Patient safety competencies in undergraduate nursing students: a rapid evidence assessment.

PubMed

Bianchi, Monica; Bressan, Valentina; Cadorin, Lucia; Pagnucci, Nicola; Tolotti, Angela; Valcarenghi, Dario; Watson, Roger; Bagnasco, Annamaria; Sasso, Loredana

2016-12-01

To identify patient safety competencies, and determine the clinical learning environments that facilitate the development of patient safety competencies in nursing students. Patient safety in nursing education is of key importance for health professional environments, settings and care systems. To be effective, safe nursing practice requires a good integration between increasing knowledge and the different clinical practice settings. Nurse educators have the responsibility to develop effective learning processes and ensure patient safety. Rapid Evidence Assessment. MEDLINE, CINAHL, SCOPUS and ERIC were searched, yielding 500 citations published between 1 January 2004-30 September 2014. Following the Rapid Evidence Assessment process, 17 studies were included in this review. Hawker's (2002) quality assessment tool was used to assess the quality of the selected studies. Undergraduate nursing students need to develop competencies to ensure patient safety. The quality of the pedagogical atmosphere in the clinical setting has an important impact on the students' overall level of competence. Active student engagement in clinical processes stimulates their critical reasoning, improves interpersonal communication and facilitates adequate supervision and feedback. Few studies describe the nursing students' patient safety competencies and exactly what they need to learn. In addition, studies describe only briefly which clinical learning environments facilitate the development of patient safety competencies in nursing students. Further research is needed to identify additional pedagogical strategies and the specific characteristics of the clinical learning environments that encourage the development of nursing students' patient safety competencies. © 2016 John Wiley & Sons Ltd.

Edible safety requirements and assessment standards for agricultural genetically modified organisms.

PubMed

Deng, Pingjian; Zhou, Xiangyang; Zhou, Peng; Du, Zhong; Hou, Hongli; Yang, Dongyan; Tan, Jianjun; Wu, Xiaojin; Zhang, Jinzhou; Yang, Yongcun; Liu, Jin; Liu, Guihua; Li, Yonghong; Liu, Jianjun; Yu, Lei; Fang, Shisong; Yang, Xiaoke

2008-05-01

This paper describes the background, principles, concepts and methods of framing the technical regulation for edible safety requirement and assessment of agricultural genetically modified organisms (agri-GMOs) for Shenzhen Special Economic Zone in the People's Republic of China. It provides a set of systematic criteria for edible safety requirements and the assessment process for agri-GMOs. First, focusing on the degree of risk and impact of different agri-GMOs, we developed hazard grades for toxicity, allergenicity, anti-nutrition effects, and unintended effects and standards for the impact type of genetic manipulation. Second, for assessing edible safety, we developed indexes and standards for different hazard grades of recipient organisms, for the influence of types of genetic manipulation and hazard grades of agri-GMOs. To evaluate the applicability of these criteria and their congruency with other safety assessment systems for GMOs applied by related organizations all over the world, we selected some agri-GMOs (soybean, maize, potato, capsicum and yeast) as cases to put through our new assessment system, and compared our results with the previous assessments. It turned out that the result of each of the cases was congruent with the original assessment.

GCSE Assessment Notes.

ERIC Educational Resources Information Center

School Science Review, 1988

1988-01-01

Contains three articles designed to help practitioners with practical assessment for the GCSE. Articles include: "GCSE Biology Practical Assessment--Can the End Justify the Means?"; "Investigating the Effect of Catalase: GCSE Assessment Practical"; and "An Experimental Design for GCSE Physics." (CW)

There is more to risk and safety planning than dramatic risks: Mental health nurses' risk assessment and safety-management practice.

PubMed

Higgins, Agnes; Doyle, Louise; Downes, Carmel; Morrissey, Jean; Costello, Paul; Brennan, Michael; Nash, Michael

2016-04-01

Risk assessment and safety planning are considered a cornerstone of mental health practice, yet limited research exists into how mental health nurses conceptualize 'risk' and how they engage with risk assessment and safety planning. The aim of the present study was to explore mental health nurses' practices and confidence in risk assessment and safety planning. A self-completed survey was administered to 381 mental health nurses in Ireland. The findings indicate that nurses focus on risk to self and risk to others, with the risk of suicide, self-harm, substance abuse, and violence being most frequently assessed. Risk from others and 'iatrogenic' risk were less frequently considered. Overall, there was limited evidence of recovery-oriented practice in relation to risk. The results demonstrate a lack of meaningful engagement with respect to collaborative safety planning, the identification and inclusion of protective factors, and the inclusion of positive risk-taking opportunities. In addition, respondents report a lack of confidence working with positive risk taking and involving family/carers in the risk-assessment and safety-planning process. Gaps in knowledge about risk-assessment and safety-planning practice, which could be addressed through education, are identified, as are the implications of the findings for practice and research. © 2015 Australian College of Mental Health Nurses Inc.

[Safety assessment of foods derived from genetically modified plants].

PubMed

Pöting, A; Schauzu, M

2010-06-01

The placing of genetically modified plants and derived food on the market falls under Regulation (EC) No. 1829/2003. According to this regulation, applicants need to perform a safety assessment according to the Guidance Document of the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA), which is based on internationally agreed recommendations. This article gives an overview of the underlying legislation as well as the strategy and scientific criteria for the safety assessment, which should generally be based on the concept of substantial equivalence and carried out in relation to an unmodified conventional counterpart. Besides the intended genetic modification, potential unintended changes also have to be assessed with regard to potential adverse effects for the consumer. All genetically modified plants and derived food products, which have been evaluated by EFSA so far, were considered to be as safe as products derived from the respective conventional plants.

Needs analysis for developing a virtual-reality NOTES simulator.

PubMed

Sankaranarayanan, Ganesh; Matthes, Kai; Nemani, Arun; Ahn, Woojin; Kato, Masayuki; Jones, Daniel B; Schwaitzberg, Steven; De, Suvranu

2013-05-01

INTRODUCTION AND STUDY AIM: Natural orifice translumenal endoscopic surgery (NOTES) is an emerging surgical technique that requires a cautious adoption approach to ensure patient safety. High-fidelity virtual-reality-based simulators allow development of new surgical procedures and tools and train medical personnel without risk to human patients. As part of a project funded by the National Institutes of Health, we are developing the virtual transluminal endoscopic surgery trainer (VTEST) for this purpose. The objective of this study is to conduct a structured needs analysis to identify the design parameters for such a virtual-reality-based simulator for NOTES. A 30-point questionnaire was distributed at the 2011 National Orifice Surgery Consortium for Assessment and Research meeting to obtain responses from experts. Ordinal logistic regression and the Wilcoxon rank-sum test were used for analysis. A total of 22 NOTES experts participated in the study. Cholecystectomy (CE, 68 %) followed by appendectomy (AE, 63 %) (CE vs AE, p = 0.0521) was selected as the first choice for simulation. Flexible (FL, 47 %) and hybrid (HY, 47 %) approaches were equally favorable compared with rigid (RI, 6 %) with p < 0.001 for both FL versus RI and HY versus RI. The transvaginal approach was preferred 3 to 1 to the transgastric. Most participants preferred two-channel (2C) scopes (65 %) compared with single (1C) or three (3C) or more channels with p < 0.001 for both 2C versus 1C and 2C versus 3C. The importance of force feedback and the utility of a virtual NOTES simulator in training and testing new tools for NOTES were rated very high by the participants. Our study reinforces the importance of developing a virtual NOTES simulator and clearly presents expert preferences. The results of this analysis will direct our initial development of the VTEST platform.

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.

Quantitative safety assessment of air traffic control systems through system control capacity

NASA Astrophysics Data System (ADS)

Guo, Jingjing

Quantitative Safety Assessments (QSA) are essential to safety benefit verification and regulations of developmental changes in safety critical systems like the Air Traffic Control (ATC) systems. Effectiveness of the assessments is particularly desirable today in the safe implementations of revolutionary ATC overhauls like NextGen and SESAR. QSA of ATC systems are however challenged by system complexity and lack of accident data. Extending from the idea "safety is a control problem" in the literature, this research proposes to assess system safety from the control perspective, through quantifying a system's "control capacity". A system's safety performance correlates to this "control capacity" in the control of "safety critical processes". To examine this idea in QSA of the ATC systems, a Control-capacity Based Safety Assessment Framework (CBSAF) is developed which includes two control capacity metrics and a procedural method. The two metrics are Probabilistic System Control-capacity (PSC) and Temporal System Control-capacity (TSC); each addresses an aspect of a system's control capacity. And the procedural method consists three general stages: I) identification of safety critical processes, II) development of system control models and III) evaluation of system control capacity. The CBSAF was tested in two case studies. The first one assesses an en-route collision avoidance scenario and compares three hypothetical configurations. The CBSAF was able to capture the uncoordinated behavior between two means of control, as was observed in a historic midair collision accident. The second case study compares CBSAF with an existing risk based QSA method in assessing the safety benefits of introducing a runway incursion alert system. Similar conclusions are reached between the two methods, while the CBSAF has the advantage of simplicity and provides a new control-based perspective and interpretation to the assessments. The case studies are intended to investigate the

Possibilities of lasers within NOTES.

PubMed

Stepp, Herbert; Sroka, Ronald

2010-10-01

Lasers possess unique properties that render them versatile light sources particularly for NOTES. Depending on the laser light sources used, diagnostic as well as therapeutic purposes can be achieved. The diagnostic potential offered by innovative concepts such as new types of ultra-thin endoscopes and optical probes supports the physician with optical information of ultra-high resolution, tissue discrimination and manifold types of fluorescence detection. In addition, the potential 3-D capability promises enhanced recognition of tissue type and pathological status. These diagnostic techniques might enable or at least contribute to accurate and safe procedures within the spatial restrictions inherent with NOTES. The therapeutic potential ranges from induction of phototoxic effects over tissue welding, coagulation and tissue cutting to stone fragmentation. As proven in many therapeutic laser endoscopic treatment concepts, laser surgery is potentially bloodless and transmits the energy without mechanical forces. Specialized NOTES endoscopes will likely incorporate suitable probes for improving diagnostic procedures, laser fibres with advantageous light delivery possibility or innovative laser beam manipulation systems. NOTES training centres may support the propagation of the complex handling and the safety aspects for clinical use to the benefit of the patient.

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.

Note taking, review, memory, and comprehension.

PubMed

Bohay, Mark; Blakely, Daniel P; Tamplin, Andrea K; Radvansky, Gabriel A

2011-01-01

In previous work assessing memory at various levels of representation, namely the surface form, textbase, and situation model levels, participants read texts but were otherwise not actively engaged with the texts. The current study tested the influence of active engagement with the material via note taking, along with the opportunity to review such notes, and the modality of presentation (text vs. spoken). The influence of these manipulations was assessed both immediately and 1 week later. In Experiment 1 participants read a text, whereas in Experiment 2 participants watched a video recording of the material being read as a lecture. For each experiment the opportunity to take notes was manipulated within participants, and the opportunity to review these notes before the test was manipulated between participants. Note taking improved performance at the situation model level in both experiments, although there was also some suggestion of benefit for the surface form. Thus, active engagement with material, such as note taking, appears to have the greatest benefit at the deeper levels of understanding.

Health and Safety Checklist for Early Care and Education Programs to Assess Key National Health and Safety Standards.

PubMed

Alkon, Abbey; Rose, Roberta; Wolff, Mimi; Kotch, Jonathan B; Aronson, Susan S

2016-01-01

The project aims were to (1) develop an observational Health and Safety Checklist to assess health and safety practices and conditions in early care and education (ECE) programs using Stepping Stones To Caring For Our Children, 3rd Edition national standards, (2) pilot test the Checklist, completed by nurse child care health consultants, to assess feasibility, ease of completion, objectivity, validity, and reliability, and (3) revise the Checklist based on the qualitative and quantitative results of the pilot study. The observable national health and safety standards were identified and then rated by health, safety, and child care experts using a Delphi technique to validate the standards as essential to prevent harm and promote health. Then, child care health consultants recruited ECE centers and pilot tested the 124-item Checklist. The pilot study was conducted in Arizona, California and North Carolina. The psychometric properties of the Checklist were assessed. The 37 participating ECE centers had 2627 children from ethnically-diverse backgrounds and primarily low-income families. The child care health consultants found the Checklist easy to complete, objective, and useful for planning health and safety interventions. The Checklist had content and face validity, inter-rater reliability, internal consistency, and concurrent validity. Based on the child care health consultant feedback and psychometric properties of the Checklist, the Checklist was revised and re-written at an 8th grade literacy level. The Health and Safety Checklist provides a standardized instrument of observable, selected national standards to assess the quality of health and safety in ECE centers.

Quantitative assessment of prevalence of pre-analytical variables and their effect on coagulation assay. Can intervention improve patient safety?

PubMed

Bhushan, Ravi; Sen, Arijit

2017-04-01

Very few Indian studies exist on evaluation of pre-analytical variables affecting "Prothrombin Time" the commonest coagulation assay performed. The study was performed in an Indian tertiary care setting with an aim to assess quantitatively the prevalence of pre-analytical variables and their effects on the results (patient safety), for Prothrombin time test. The study also evaluated their effects on the result and whether intervention, did correct the results. The firstly evaluated the prevalence for various pre-analytical variables detected in samples sent for Prothrombin Time testing. These samples with the detected variables wherever possible were tested and result noted. The samples from the same patients were repeated and retested ensuring that no pre-analytical variable is present. The results were again noted to check for difference the intervention produced. The study evaluated 9989 samples received for PT/INR over a period of 18 months. The prevalence of different pre-analytical variables was found to be 862 (8.63%). The proportion of various pre-analytical variables detected were haemolysed samples 515 (5.16%), over filled vacutainers 62 (0.62%), under filled vacutainers 39 (0.39%), low values 205 (2.05%), clotted samples 11 (0.11%), wrong labeling 4 (0.04%), wrong vacutainer use 2 (0.02%), chylous samples 7 (0.07%) and samples with more than one variable 17 (0.17%). The comparison of percentage of samples showing errors were noted for the first variables since they could be tested with and without the variable in place. The reduction in error percentage was 91.5%, 69.2%, 81.5% and 95.4% post intervention for haemolysed, overfilled, under filled and samples collected with excess pressure at phlebotomy respectively. Correcting the variables did reduce the error percentage to a great extent in these four variables and hence the variables are found to affect "Prothrombin Time" testing and can hamper patient safety.

Environment, Safety, and Health Self-Assessment Report, Fiscal Year 2008

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

Chernowski, John

2009-02-27

Lawrence Berkeley National Laboratory's Environment, Safety, and Health (ES&H) Self-Assessment Program ensures that Integrated Safety Management (ISM) is implemented institutionally and by all divisions. The Self-Assessment Program, managed by the Office of Contract Assurance (OCA), provides for an internal evaluation of all ES&H programs and systems at LBNL. The functions of the program are to ensure that work is conducted safely, and with minimal negative impact to workers, the public, and the environment. The Self-Assessment Program is also the mechanism used to institute continuous improvements to the Laboratory's ES&H programs. The program is described in LBNL/PUB 5344, Environment, Safety, andmore » Health Self-Assessment Program and is composed of four distinct assessments: the Division Self-Assessment, the Management of Environment, Safety, and Health (MESH) review, ES&H Technical Assurance, and the Appendix B Self-Assessment. The Division Self-Assessment uses the five core functions and seven guiding principles of ISM as the basis of evaluation. Metrics are created to measure performance in fulfilling ISM core functions and guiding principles, as well as promoting compliance with applicable regulations. The five core functions of ISM are as follows: (1) Define the Scope of Work; (2) Identify and Analyze Hazards; (3) Control the Hazards; (4) Perform the Work; and (5) Feedback and Improvement. The seven guiding principles of ISM are as follows: (1) Line Management Responsibility for ES&H; (2) Clear Roles and Responsibilities; (3) Competence Commensurate with Responsibilities; (4) Balanced Priorities; (5) Identification of ES&H Standards and Requirements; (6) Hazard Controls Tailored to the Work Performed; and (7) Operations Authorization. Performance indicators are developed by consensus with OCA, representatives from each division, and Environment, Health, and Safety (EH&S) Division program managers. Line management of each division performs the Division

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.

Simulating geriatric home safety assessments in a three-dimensional virtual world.

PubMed

Andrade, Allen D; Cifuentes, Pedro; Mintzer, Michael J; Roos, Bernard A; Anam, Ramanakumar; Ruiz, Jorge G

2012-01-01

Virtual worlds could offer inexpensive and safe three-dimensional environments in which medical trainees can learn to identify home safety hazards. Our aim was to evaluate the feasibility, usability, and acceptability of virtual worlds for geriatric home safety assessments and to correlate performance efficiency in hazard identification with spatial ability, self-efficacy, cognitive load, and presence. In this study, 30 medical trainees found the home safety simulation easy to use, and their self-efficacy was improved. Men performed better than women in hazard identification. Presence and spatial ability were correlated significantly with performance. Educators should consider spatial ability and gender differences when implementing virtual world training for geriatric home safety assessments.

Safety assessment of genetically modified plants with deliberately altered composition

PubMed Central

Halford, Nigel G; Hudson, Elizabeth; Gimson, Amy; Weightman, Richard; Shewry, Peter R; Tompkins, Steven

2014-01-01

The development and marketing of ‘novel’ genetically modified (GM) crops in which composition has been deliberately altered poses a challenge to the European Union (EU)'s risk assessment processes, which are based on the concept of substantial equivalence with a non-GM comparator. This article gives some examples of these novel GM crops and summarizes the conclusions of a report that was commissioned by the European Food Safety Authority on how the EU's risk assessment processes could be adapted to enable their safety to be assessed. PMID:24735114

Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250).

PubMed

Noguera, José F; Cuadrado, Angel; Dolz, Carlos; Olea, José M; García, Juan C

2012-12-01

Natural orifice transluminal endoscopic surgery (NOTES) is a technique still in experimental development whose safety and effectiveness call for assessment through clinical trials. In this paper we present a three-arm, noninferiority, prospective randomized clinical trial of 1 year duration comparing the vaginal and transumbilical approaches for transluminal endoscopic surgery with the conventional laparoscopic approach for elective cholecystectomy. Sixty female patients between the ages of 18 and 65 years who were eligible for elective cholecystectomy were randomized in a ratio of 1:1:1 to receive hybrid transvaginal NOTES (TV group), hybrid transumbilical NOTES (TU group) or conventional laparoscopy (CL group). The main study variable was parietal complications (wound infection, bleeding, and eventration). The analysis was by intention to treat, and losses were not replaced. Cholecystectomy was successfully performed on 94% of the patients. One patient in the TU group was reconverted to CL owing to difficulty in maneuvering the endoscope. After a minimum follow-up period of 1 year, no differences were noted in the rate of parietal complications. Postoperative pain, length of hospital stay, and time off from work were similar in the three groups. No patient developed dyspareunia. Surgical time was longer among cases in which a flexible endoscope was used (CL, 47.04 min; TV, 64.85 min; TU, 59.80 min). NOTES approaches using the flexible endoscope are not inferior in safety or effectiveness to conventional laparoscopy. The transumbilical approach with flexible endoscope is as effective and safe as the transvaginal approach and is a promising, single-incision approach.

Data collection and analysis for local roadway safety assessment.

DOT National Transportation Integrated Search

2014-11-01

The project Data Analysis for Local Roadway : Assessment conducted systematic road-safety : assessment and identified major risks that can be el : iminated or reduced by pr : actical road-improvement : measures. Specifically, the primary task o...

Ex-ante assessment of the safety effects of intelligent transport systems.

PubMed

Kulmala, Risto

2010-07-01

There is a need to develop a comprehensive framework for the safety assessment of Intelligent Transport Systems (ITS). This framework should: (1) cover all three dimensions of road safety-exposure, crash risk and consequence, (2) cover, in addition to the engineering effect, also the effects due to behavioural adaptation and (3) be compatible with the other aspects of state of the art road safety theories. A framework based on nine ITS safety mechanisms is proposed and discussed with regard to the requirements set to the framework. In order to illustrate the application of the framework in practice, the paper presents a method based on the framework and the results from applying that method for twelve intelligent vehicle systems in Europe. The framework is also compared to two recent frameworks applied in the safety assessment of intelligent vehicle safety systems. Copyright 2010 Elsevier Ltd. All rights reserved.

Safety assessment guidance in the International Atomic Energy Agency RADWASS Program

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

Vovk, I.F.; Seitz, R.R.

1995-12-31

The IAEA RADWASS programme is aimed at establishing a coherent and comprehensive set of principles and standards for the safe management of waste and formulating the guidelines necessary for their application. A large portion of this programme has been devoted to safety assessments for various waste management activities. Five Safety Guides are planned to be developed to provide general guidance to enable operators and regulators to develop necessary framework for safety assessment process in accordance with international recommendations. They cover predisposal, near surface disposal, geological disposal, uranium/thorium mining and milling waste, and decommissioning and environmental restoration. The Guide on safetymore » assessment for near surface disposal is at the most advanced stage of preparation. This draft Safety Guide contains guidance on description of the disposal system, development of a conceptual model, identification and description of relevant scenarios and pathways, consequence analysis, presentation of results and confidence building. The set of RADWASS publications is currently undergoing in-depth review to ensure a harmonized approach throughout the Safety Series.« less

Assessment of the safety of foods derived from genetically modified (GM) crops.

PubMed

König, A; Cockburn, A; Crevel, R W R; Debruyne, E; Grafstroem, R; Hammerling, U; Kimber, I; Knudsen, I; Kuiper, H A; Peijnenburg, A A C M; Penninks, A H; Poulsen, M; Schauzu, M; Wal, J M

2004-07-01

This paper provides guidance on how to assess the safety of foods derived from genetically modified crops (GM crops); it summarises conclusions and recommendations of Working Group 1 of the ENTRANSFOOD project. The paper provides an approach for adapting the test strategy to the characteristics of the modified crop and the introduced trait, and assessing potential unintended effects from the genetic modification. The proposed approach to safety assessment starts with the comparison of the new GM crop with a traditional counterpart that is generally accepted as safe based on a history of human food use (the concept of substantial equivalence). This case-focused approach ensures that foods derived from GM crops that have passed this extensive test-regime are as safe and nutritious as currently consumed plant-derived foods. The approach is suitable for current and future GM crops with more complex modifications. First, the paper reviews test methods developed for the risk assessment of chemicals, including food additives and pesticides, discussing which of these methods are suitable for the assessment of recombinant proteins and whole foods. Second, the paper presents a systematic approach to combine test methods for the safety assessment of foods derived from a specific GM crop. Third, the paper provides an overview on developments in this area that may prove of use in the safety assessment of GM crops, and recommendations for research priorities. It is concluded that the combination of existing test methods provides a sound test-regime to assess the safety of GM crops. Advances in our understanding of molecular biology, biochemistry, and nutrition may in future allow further improvement of test methods that will over time render the safety assessment of foods even more effective and informative. Copryright 2004 Elsevier Ltd.

Assessment of elementary school safety restraint programs.

DOT National Transportation Integrated Search

1985-06-01

The purpose of this research was to identify elementary school (K-6) safety belt : education programs in use in the United States, to review their development, and : to make administrative and impact assessments of their use in selected States. : Six...

Social Work Assessment Notes: A Comprehensive Outcomes-Based Hospice Documentation System.

PubMed

Hansen, Angela Gregory; Martin, Ellen; Jones, Barbara L; Pomeroy, Elizabeth C

2015-08-01

This article describes the development of an integrated psychosocial patient and caregiver assessment and plan of care for hospice social work documentation. A team of hospice social workers developed the Social Work Assessment Notes as a quality improvement project in collaboration with the information technology department. Using the Social Work Assessment Tool as an organizing framework, this comprehensive hospice social work documentation system is designed to integrate assessment, planning, and outcomes measurement. The system was developed to guide the assessment of patients' and caregivers' needs related to end-of-life psychosocial issues, to facilitate collaborative care plan development, and to measure patient- and family-centered outcomes. Goals established with the patient and the caregiver are documented in the plan of care and become the foundation for patient-centered, strengths-based interventions. Likert scales are used to assign numerical severity levels for identified issues and progress made toward goals and to track the outcome of social work interventions across nine psychosocial constructs. The documentation system was developed for use in an electronic health record but can be used for paper charting. Future plans include automated aggregate outcomes measurement to identify the most effective interventions and best practices in end-of-life care.

Ultraviolet safety assessments of insect light traps.

PubMed

Sliney, David H; Gilbert, David W; Lyon, Terry

2016-01-01

Near-ultraviolet (UV-A: 315-400 nm), "black-light," electric lamps were invented in 1935 and ultraviolet insect light traps (ILTs) were introduced for use in agriculture around that time. Today ILTs are used indoors in several industries and in food-service as well as in outdoor settings. With recent interest in photobiological lamp safety, safety standards are being developed to test for potentially hazardous ultraviolet emissions. A variety of UV "Black-light" ILTs were measured at a range of distances to assess potential exposures. Realistic time-weighted human exposures are shown to be well below current guidelines for human exposure to ultraviolet radiation. These UV-A exposures would be far less than the typical UV-A exposure in the outdoor environment. Proposals are made for realistic ultraviolet safety standards for ILT products.

Safety Assessment of Acyl Glucuronides-A Simplified Paradigm.

PubMed

Smith, Dennis A; Hammond, Timothy; Baillie, Thomas A

2018-06-01

While simple O - (ether-linked) and N -glucuronide drug conjugates generally are unreactive and considered benign from a safety perspective, the acyl glucuronides that derive from metabolism of carboxylic acid-containing xenobiotics can exhibit a degree of chemical reactivity that is dependent upon their molecular structure. As a result, concerns have arisen over the safety of acyl glucuronides as a class, several members of which have been implicated in the toxicity of their respective parent drugs. However, direct evidence in support of these claims remains sparse, and due to frequently encountered species differences in the systemic exposure to acyl glucuronides (both of the parent drug and oxidized derivatives thereof), coupled with their instability in aqueous media and potential to undergo chemical rearrangement (acyl migration), qualification of these conjugates by traditional safety assessment methods can be very challenging. In this Commentary, we discuss alternative (non-acyl glucuronide) mechanisms by which carboxylic acids may cause serious adverse reactions, and propose a novel, practical approach to compare systemic exposure to acyl glucuronide metabolites in humans to that in animal species used in preclinical safety assessment based on relative estimates of the total body burden of these circulating conjugates. Copyright © 2018 by The American Society for Pharmacology and Experimental Therapeutics.

Critical safety assurance factors for manned spacecraft - A fire safety perspective

NASA Technical Reports Server (NTRS)

Rodney, George A.

1990-01-01

Safety assurance factors for manned spacecraft are discussed with a focus on the Space Station Freedom. A hazard scenario is provided to demonstrate a process commonly used by safety engineers and other analysts to identify onboard safety risks. Fire strategies are described, including a review of fire extinguishing agents being considered for the Space Station. Lessons learned about fire safety technology in other areas are also noted. NASA and industry research on fire safety applications is discussed. NASA's approach to ensuring safety for manned spacecraft is addressed in the context of its multidiscipline program.

A TIERED APPROACH TO LIFE STAGES TESTING FOR AGRICULTURAL CHEMICAL SAFETY ASSESSMENT

EPA Science Inventory

A proposal has been developed by the Agricultural Chemical Safety Assessment (ACSA) Technical Committee of the ILSI Health and Environmental Sciences Institute (HESI) for an improved approach to assessing the safety of crop protection chemicals. The goal is to ensure that studie...

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.

Assessment of patient safety culture in private and public hospitals in Peru.

PubMed

Arrieta, Alejandro; Suárez, Gabriela; Hakim, Galed

2018-04-01

To assess the patient safety culture in Peruvian hospitals from the perspective of healthcare professionals, and to test for differences between the private and public healthcare sectors. Patient safety is defined as the avoidance and prevention of patient injuries or adverse events resulting from the processes of healthcare delivery. A non-random cross-sectional study conducted online. An online survey was administered from July to August 2016, in Peru. This study reports results from Lima and Callao, which are the capital and the port region of Peru. A total of 1679 healthcare professionals completed the survey. Participants were physicians, medical residents and nurses working in healthcare facilities from the private sector and public sector. Assessment of the degree of patient safety and 12 dimensions of patient safety culture in hospital units as perceived by healthcare professionals. Only 18% of healthcare professionals assess the degree of patient safety in their unit of work as excellent or very good. Significant differences are observed between the patient safety grades in the private sector (37%) compared to the public sub-sectors (13-15%). Moreover, in all patient safety culture dimensions, healthcare professionals from the private sector give more favorable responses for patient safety, than those from the public sub-systems. The most significant difference in support comes from patient safety administrators through communication and information about errors. Overall, the degree of patient safety in Peru is low, with significant gaps that exist between the private and the public sectors.

Post-earthquake building safety assessments for the Canterbury Earthquakes

USGS Publications Warehouse

Marshall, J.; Barnes, J.; Gould, N.; Jaiswal, K.; Lizundia, B.; Swanson, David A.; Turner, F.

2012-01-01

This paper explores the post-earthquake building assessment program that was utilized in Christchurch, New Zealand following the Canterbury Sequence of earthquakes beginning with the Magnitude (Mw.) 7.1 Darfield event in September 2010. The aftershocks or triggered events, two of which exceeded Mw 6.0, continued with events in February and June 2011 causing the greatest amount of damage. More than 70,000 building safety assessments were completed following the February event. The timeline and assessment procedures will be discussed including the use of rapid response teams, selection of indicator buildings to monitor damage following aftershocks, risk assessments for demolition of red-tagged buildings, the use of task forces to address management of the heavily damaged downtown area and the process of demolition. Through the post-event safety assessment program that occurred throughout the Canterbury Sequence of earthquakes, many important lessons can be learned that will benefit future response to natural hazards that have potential to damage structures.

Patient involvement in patient safety: Protocol for developing an intervention using patient reports of organisational safety and patient incident reporting.

PubMed

Ward, Jane K; McEachan, Rosemary R C; Lawton, Rebecca; Armitage, Gerry; Watt, Ian; Wright, John

2011-05-27

Patients have the potential to provide a rich source of information on both organisational aspects of safety and patient safety incidents. This project aims to develop two patient safety interventions to promote organisational learning about safety - a patient measure of organisational safety (PMOS), and a patient incident reporting tool (PIRT) - to help the NHS prevent patient safety incidents by learning more about when and why they occur. To develop the PMOS 1) literature will be reviewed to identify similar measures and key contributory factors to error; 2) four patient focus groups will ascertain practicality and feasibility; 3) 25 patient interviews will elicit approximately 60 items across 10 domains; 4) 10 patient and clinician interviews will test acceptability and understanding. Qualitative data will be analysed using thematic content analysis.To develop the PIRT 1) individual and then combined patient and clinician focus groups will provide guidance for the development of three potential reporting tools; 2) nine wards across three hospital directorates will pilot each of the tools for three months. The best performing tool will be identified from the frequency, volume and quality of reports. The validity of both measures will be tested. 300 patients will be asked to complete the PMOS and PIRT during their stay in hospital. A sub-sample (N = 50) will complete the PMOS again one week later. Health professionals in participating wards will also be asked to complete the AHRQ safety culture questionnaire. Case notes for all patients will be reviewed. The psychometric properties of the PMOS will be assessed and a final valid and reliable version developed. Concurrent validity for the PIRT will be assessed by comparing reported incidents with those identified from case note review and the existing staff reporting scheme. In a subsequent study these tools will be used to provide information to wards/units about their priorities for patient safety. A patient

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.

Safety assessment of discharge chute isolation barrier preparation and installation. Revision 1

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

Meichle, R.H.

1994-10-10

This revision responds to RL comments and increases the discussion of the ``effective hazard categorization`` and the readiness review basis. The safety assessment is made for the activities for the preparation and installation of the discharge chute isolation barriers. The safety assessment includes a hazard assessment and comparison of potential accidents/events to those addressed by the current safety basis documentation. No significant hazards were identified. An evaluation against the USQ evaluation questions were made and the determination made that the activities do not represent a USQ. Hazard categorization techniques were used to provide a basis for readiness review classification.

Ultraviolet safety assessments of insect light traps

PubMed Central

Sliney, David H.; Gilbert, David W.; Lyon, Terry

2016-01-01

ABSTRACT Near-ultraviolet (UV-A: 315–400 nm), “black-light,” electric lamps were invented in 1935 and ultraviolet insect light traps (ILTs) were introduced for use in agriculture around that time. Today ILTs are used indoors in several industries and in food-service as well as in outdoor settings. With recent interest in photobiological lamp safety, safety standards are being developed to test for potentially hazardous ultraviolet emissions. A variety of UV “Black-light” ILTs were measured at a range of distances to assess potential exposures. Realistic time-weighted human exposures are shown to be well below current guidelines for human exposure to ultraviolet radiation. These UV-A exposures would be far less than the typical UV-A exposure in the outdoor environment. Proposals are made for realistic ultraviolet safety standards for ILT products. PMID:27043058

Open Oncology Notes: A Qualitative Study of Oncology Patients' Experiences Reading Their Cancer Care Notes.

PubMed

Kayastha, Neha; Pollak, Kathryn I; LeBlanc, Thomas W

2018-04-01

Electronic medical records increasingly allow patients access to clinician notes. Although most believe that open notes benefits patients, some suggest negative consequences. Little is known about the experiences of patients with cancer reading their medical notes; thus we aimed to describe this qualitatively. We interviewed 20 adults with metastatic or incurable cancer receiving cancer treatment. The semistructured qualitative interviews included four segments: assessing their overall experience reading notes, discussing how notes affected their cancer care experiences, reading a real note with the interviewer, and making suggestions for improvement. We used a constant comparison approach to analyze these qualitative data. We found four themes. Patients reported that notes resulted in the following: (1) increased comprehension; (2) ameliorated uncertainty, relieved anxiety, and facilitated control; (3) increased trust; and (4) for a subset of patients, increased anxiety. Patients described increased comprehension because notes refreshed their memory and clarified their understanding of visits. This helped mitigate the unfamiliarity of cancer, addressing uncertainty and relieving anxiety. Notes facilitated control, empowering patients to ask clinicians more questions. The transparency of notes also increased trust in clinicians. For a subset of patients, however, notes were emotionally difficult to read and raised concerns. Patients identified medical jargon and repetition in notes as areas for improvement. Most patients thought that reading notes improved their care experiences. A small subset of patients experienced increased distress. As reading notes becomes a routine part of the patient experience, physicians might want to elicit and address concerns that arise from notes, thereby further engaging patients in their care.

Validity of instruments to assess students' travel and pedestrian safety.

PubMed

Mendoza, Jason A; Watson, Kathy; Baranowski, Tom; Nicklas, Theresa A; Uscanga, Doris K; Hanfling, Marcus J

2010-05-18

Safe Routes to School (SRTS) programs are designed to make walking and bicycling to school safe and accessible for children. Despite their growing popularity, few validated measures exist for assessing important outcomes such as type of student transport or pedestrian safety behaviors. This research validated the SRTS school travel survey and a pedestrian safety behavior checklist. Fourth grade students completed a brief written survey on how they got to school that day with set responses. Test-retest reliability was obtained 3-4 hours apart. Convergent validity of the SRTS travel survey was assessed by comparison to parents' report. For the measure of pedestrian safety behavior, 10 research assistants observed 29 students at a school intersection for completion of 8 selected pedestrian safety behaviors. Reliability was determined in two ways: correlations between the research assistants' ratings to that of the Principal Investigator (PI) and intraclass correlations (ICC) across research assistant ratings. The SRTS travel survey had high test-retest reliability (kappa = 0.97, n = 96, p < 0.001) and convergent validity (kappa = 0.87, n = 81, p < 0.001). The pedestrian safety behavior checklist had moderate reliability across research assistants' ratings (ICC = 0.48) and moderate correlation with the PI (r = 0.55, p = < 0.01). When two raters simultaneously used the instrument, the ICC increased to 0.65. Overall percent agreement (91%), sensitivity (85%) and specificity (83%) were acceptable. These validated instruments can be used to assess SRTS programs. The pedestrian safety behavior checklist may benefit from further formative work.

Validity of instruments to assess students' travel and pedestrian safety

PubMed Central

2010-01-01

Background Safe Routes to School (SRTS) programs are designed to make walking and bicycling to school safe and accessible for children. Despite their growing popularity, few validated measures exist for assessing important outcomes such as type of student transport or pedestrian safety behaviors. This research validated the SRTS school travel survey and a pedestrian safety behavior checklist. Methods Fourth grade students completed a brief written survey on how they got to school that day with set responses. Test-retest reliability was obtained 3-4 hours apart. Convergent validity of the SRTS travel survey was assessed by comparison to parents' report. For the measure of pedestrian safety behavior, 10 research assistants observed 29 students at a school intersection for completion of 8 selected pedestrian safety behaviors. Reliability was determined in two ways: correlations between the research assistants' ratings to that of the Principal Investigator (PI) and intraclass correlations (ICC) across research assistant ratings. Results The SRTS travel survey had high test-retest reliability (κ = 0.97, n = 96, p < 0.001) and convergent validity (κ = 0.87, n = 81, p < 0.001). The pedestrian safety behavior checklist had moderate reliability across research assistants' ratings (ICC = 0.48) and moderate correlation with the PI (r = 0.55, p =< 0.01). When two raters simultaneously used the instrument, the ICC increased to 0.65. Overall percent agreement (91%), sensitivity (85%) and specificity (83%) were acceptable. Conclusions These validated instruments can be used to assess SRTS programs. The pedestrian safety behavior checklist may benefit from further formative work. PMID:20482778

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

Code of Federal Regulations, 2013 CFR

2013-10-01

... motorcyclist safety; (10) Section 2011 [23 U.S.C. 405 note], relating to child safety and child booster seat... 10306, relating to the study of safety belt use technologies; (24) Section 10307(b) [15 U.S.C. 1232 note...

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

Code of Federal Regulations, 2012 CFR

2012-10-01

... motorcyclist safety; (10) Section 2011 [23 U.S.C. 405 note], relating to child safety and child booster seat... 10306, relating to the study of safety belt use technologies; (24) Section 10307(b) [15 U.S.C. 1232 note...

Adverse Outcome Pathways can drive non-animal approaches for safety assessment

PubMed Central

Burden, Natalie; Sewell, Fiona; Andersen, Melvin E; Boobis, Alan; Chipman, J Kevin; Cronin, Mark T D; Hutchinson, Thomas H; Kimber, Ian; Whelan, Maurice

2015-01-01

Adverse Outcome Pathways (AOPs) provide an opportunity to develop new and more accurate safety assessment processes for drugs and other chemicals, and may ultimately play an important role in regulatory decision making. Not only can the development and application of AOPs pave the way for the development of improved evidence-based approaches for hazard and risk assessment, there is also the promise of a significant impact on animal welfare, with a reduced reliance on animal-based methods. The establishment of a useable and coherent knowledge framework under which AOPs will be developed and applied has been a first critical step towards realizing this opportunity. This article explores how the development of AOPs under this framework, and their application in practice, could benefit the science and practice of safety assessment, while in parallel stimulating a move away from traditional methods towards an increased acceptance of non-animal approaches. We discuss here the key areas where current, and future initiatives should be focused to enable the translation of AOPs into routine chemical safety assessment, and lasting 3Rs benefits. © 2015 The Authors. Journal of Applied Toxicology published by John Wiley & Sons Ltd. This article explores how the development and application of Adverse Outcome Pathways (AOPs) could benefit the science and practice of chemical safety assessment, with a particular focus on how their use in practice could reduce reliance on traditional animal toxicity tests. This includes discussion of the key areas where current and future initiatives should be focused to enable the translation of AOPs into routine chemical safety assessment, and lasting 3Rs benefits. PMID:25943792

Revealing and Resolving Patient Safety Defects: The Impact of Leadership WalkRounds on Frontline Caregiver Assessments of Patient Safety

PubMed Central

Frankel, Allan; Grillo, Sarah Pratt; Pittman, Mary; Thomas, Eric J; Horowitz, Lisa; Page, Martha; Sexton, Bryan

2008-01-01

Objective To evaluate the impact of rigorous WalkRounds on frontline caregiver assessments of safety climate, and to clarify the steps and implementation of rigorous WalkRounds. Data Sources/Study Setting Primary outcome variables were baseline and post WalkRounds safety climate scores from the Safety Attitudes Questionnaire (SAQ). Secondary outcomes were safety issues elicited through WalkRounds. Study period was August 2002 to April 2005; seven hospitals in Massachusetts agreed to participate; and the project was implemented in all patient care areas. Study Design Prospective study of the impact of rigorously applied WalkRounds on frontline caregivers assessments of safety climate in their patient care area. WalkRounds were conducted weekly and according to the seven-step WalkRounds Guide. The SAQ was administered at baseline and approximately 18 months post-WalkRounds implementation to all caregivers in patient care areas. Results Two of seven hospitals complied with the rigorous WalkRounds approach; hospital A was an academic teaching center and hospital B a community teaching hospital. Of 21 patient care areas, SAQ surveys were received from 62 percent of respondents at baseline and 60 percent post WalkRounds. At baseline, 10 of 21 care areas (48 percent) had safety climate scores below 60 percent, whereas post-WalkRounds three care areas (14 percent) had safety climate scores below 60 percent without improving by 10 points or more. Safety climate scale scores in hospital A were 62 percent at baseline and 77 percent post-WalkRounds (t=2.67, p=.03), and in hospital B were 46 percent at baseline and 56 percent post WalkRounds (t=2.06, p=.06). Main safety issues by category were equipment/facility (A [26 percent] and B [33 percent]) and communication (A [24 percent] and B [18 percent]). Conclusions WalkRounds implementation requires significant organizational will; sustainability requires outstanding project management and leadership engagement. In the patient

Review of quality assessment tools for the evaluation of pharmacoepidemiological safety studies

PubMed Central

Neyarapally, George A; Hammad, Tarek A; Pinheiro, Simone P; Iyasu, Solomon

2012-01-01

Objectives Pharmacoepidemiological studies are an important hypothesis-testing tool in the evaluation of postmarketing drug safety. Despite the potential to produce robust value-added data, interpretation of findings can be hindered due to well-recognised methodological limitations of these studies. Therefore, assessment of their quality is essential to evaluating their credibility. The objective of this review was to evaluate the suitability and relevance of available tools for the assessment of pharmacoepidemiological safety studies. Design We created an a priori assessment framework consisting of reporting elements (REs) and quality assessment attributes (QAAs). A comprehensive literature search identified distinct assessment tools and the prespecified elements and attributes were evaluated. Primary and secondary outcome measures The primary outcome measure was the percentage representation of each domain, RE and QAA for the quality assessment tools. Results A total of 61 tools were reviewed. Most tools were not designed to evaluate pharmacoepidemiological safety studies. More than 50% of the reviewed tools considered REs under the research aims, analytical approach, outcome definition and ascertainment, study population and exposure definition and ascertainment domains. REs under the discussion and interpretation, results and study team domains were considered in less than 40% of the tools. Except for the data source domain, quality attributes were considered in less than 50% of the tools. Conclusions Many tools failed to include critical assessment elements relevant to observational pharmacoepidemiological safety studies and did not distinguish between REs and QAAs. Further, there is a lack of considerations on the relative weights of different domains and elements. The development of a quality assessment tool would facilitate consistent, objective and evidence-based assessments of pharmacoepidemiological safety studies. PMID:23015600

A 2-year study of patient safety competency assessment in 29 clinical laboratories.

PubMed

Reed, Robyn C; Kim, Sara; Farquharson, Kara; Astion, Michael L

2008-06-01

Competency assessment is critical for laboratory operations and is mandated by the Clinical Laboratory Improvement Amendments of 1988. However, no previous reports describe methods for assessing competency in patient safety. We developed and implemented a Web-based tool to assess performance of 875 laboratory staff from 29 laboratories in patient safety. Question categories included workplace culture, categorizing error, prioritization of patient safety interventions, strength of specific interventions, and general patient safety concepts. The mean score was 85.0%, with individual scores ranging from 56% to 100% and scores by category from 81.3% to 88.6%. Of the most difficult questions (<72% correct), 6 were about intervention strength, 3 about categorizing error, 1 about workplace culture, and 1 about prioritization of interventions. Of the 13 questions about intervention strength, 6 (46%) were in the lowest quartile, suggesting that this may be a difficult topic for laboratory technologists. Computer-based competency assessments help laboratories identify topics for continuing education in patient safety.

Safety assessment for In-service Pressure Bending Pipe Containing Incomplete Penetration Defects

NASA Astrophysics Data System (ADS)

Wang, M.; Tang, P.; Xia, J. F.; Ling, Z. W.; Cai, G. Y.

2017-12-01

Incomplete penetration defect is a common defect in the welded joint of pressure pipes. While the safety classification of pressure pipe containing incomplete penetration defects, according to periodical inspection regulations in present, is more conservative. For reducing the repair of incomplete penetration defect, a scientific and applicable safety assessment method for pressure pipe is needed. In this paper, the stress analysis model of the pipe system was established for the in-service pressure bending pipe containing incomplete penetration defects. The local finite element model was set up to analyze the stress distribution of defect location and the stress linearization. And then, the applicability of two assessment methods, simplified assessment and U factor assessment method, to the assessment of incomplete penetration defects located at pressure bending pipe were analyzed. The results can provide some technical supports for the safety assessment of complex pipelines in the future.

Assessing Emotional Suffering in Palliative Care: Use of a Structured Note Template to Improve Documentation.

PubMed

Lamba, Sangeeta; Berlin, Ana; Goett, Rebecca; Ponce, Christopher B; Holland, Bart; Walther, Susanne

2016-07-01

Documentation of the emotional or psychological needs of seriously ill patients receiving specialty palliative care is endorsed by the "Measuring What Matters" project as a quality performance metric and recommended for use by hospice and palliative care programs for program improvement. The aim of this study was to increase the proportion of inpatient palliative care team encounters in which emotional or psychological needs of patients and family members were documented and to qualitatively enrich the nature of this documentation. This is a mixed-methods retrospective study of 200 patient charts reviewed before and after implementation of a structured note template (SmartPhrase) for palliative care encounters. Patterns of documentation of emotional needs pre- and post-implementation were assessed quantitatively and qualitatively using thematic analysis. A total of 158 of 200 pre-intervention charts and 185 of 200 post-intervention charts included at least one note from the palliative care team. Documentation of emotional assessment increased after SmartPhrase implementation (63.9% [101 of 158] vs. 74.6% [138 of 185]; P < 0.03). Qualitative analysis revealed a post-intervention reduction in the use of generic phrases ("emotional support provided") and an increase in the breadth and depth of emotion-related documentation. A structured note template with a prompt for emotional assessment increases the overall quantity and richness of documentation related to patient and family emotions. However, this documentation remains mostly descriptive. Additional prompting for documentation of recommendations to address identified emotional needs, and the use of screening tools for depression and anxiety, when appropriate, may be necessary for clinically meaningful quality improvements in patient care. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Post-earthquake building safety inspection: Lessons from the Canterbury, New Zealand, earthquakes

USGS Publications Warehouse

Marshall, J.; Jaiswal, Kishor; Gould, N.; Turner, F.; Lizundia, B.; Barnes, J.

2013-01-01

The authors discuss some of the unique aspects and lessons of the New Zealand post-earthquake building safety inspection program that was implemented following the Canterbury earthquake sequence of 2010–2011. The post-event safety assessment program was one of the largest and longest programs undertaken in recent times anywhere in the world. The effort engaged hundreds of engineering professionals throughout the country, and also sought expertise from outside, to perform post-earthquake structural safety inspections of more than 100,000 buildings in the city of Christchurch and the surrounding suburbs. While the building safety inspection procedure implemented was analogous to the ATC 20 program in the United States, many modifications were proposed and implemented in order to assess the large number of buildings that were subjected to strong and variable shaking during a period of two years. This note discusses some of the key aspects of the post-earthquake building safety inspection program and summarizes important lessons that can improve future earthquake response.

Current issues and perspectives in food safety and risk assessment.

PubMed

Eisenbrand, G

2015-12-01

In this review, current issues and opportunities in food safety assessment are discussed. Food safety is considered an essential element inherent in global food security. Hazard characterization is pivotal within the continuum of risk assessment, but it may be conceived only within a very limited frame as a true alternative to risk assessment. Elucidation of the mode of action underlying a given hazard is vital to create a plausible basis for human toxicology evaluation. Risk assessment, to convey meaningful risk communication, must be based on appropriate and reliable consideration of both exposure and mode of action. New perspectives, provided by monitoring human exogenous and endogenous exposure biomarkers, are considered of great promise to support classical risk extrapolation from animal toxicology. © The Author(s) 2015.

Using driving simulators to assess driving safety.

PubMed

Boyle, Linda Ng; Lee, John D

2010-05-01

Changes in drivers, vehicles, and roadways pose substantial challenges to the transportation safety community. Crash records and naturalistic driving data are useful for examining the influence of past or existing technology on drivers, and the associations between risk factors and crashes. However, they are limited because causation cannot be established and technology not yet installed in production vehicles cannot be assessed. Driving simulators have become an increasingly widespread tool to understand evolving and novel technologies. The ability to manipulate independent variables in a randomized, controlled setting also provides the added benefit of identifying causal links. This paper introduces a special issue on simulator-based safety studies. The special issue comprises 25 papers that demonstrate the use of driving simulators to address pressing transportation safety problems and includes topics as diverse as neurological dysfunction, work zone design, and driver distraction. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

Duly noted: Lessons from a two-site intervention to assess and improve the quality of clinical documentation in the electronic health record.

PubMed

Fanucchi, Laura; Yan, Donglin; Conigliaro, Rosemarie L

2016-07-06

Communication errors are identified as a root cause contributing to a majority of sentinel events. The clinical note is a cornerstone of physician communication, yet there are few published interventions on teaching note writing in the electronic health record (EHR). This is a prospective, two-site, quality improvement project to assess and improve the quality of clinical documentation in the EHR using a validated assessment tool. Internal Medicine (IM) residents at the University of Kentucky College of Medicine (UK) and Montefiore Medical Center/Albert Einstein College of Medicine (MMC) received one of two interventions during an inpatient ward month: either a lecture, or a lecture and individual feedback on progress notes. A third group of residents in each program served as control. Notes were evaluated with the Physician Documentation Quality Instrument 9 (PDQI-9). Due to a significant difference in baseline PDQI-9 scores at MMC, the sites were not combined. Of 75 residents at the UK site, 22 were eligible, 20 (91%) enrolled, 76 notes in total were scored. Of 156 residents at MMC, 22 were eligible, 18 (82%) enrolled, 40 notes in total were scored. Note quality did not improve as measured by the PDQI-9. This educational quality improvement project did not improve the quality of clinical documentation as measured by the PDQI-9. This project underscores the difficulty in improving note quality. Further efforts should explore more effective educational tools to improve the quality of clinical documentation in the EHR.

INTERPRETING SPONTANEOUS RENAL LESIONS IN SAFETY AND RISK ASSESSMENT

EPA Science Inventory

Interpreting Spontaneous Renal Lesions in Safety and Risk Assessment
Douglas C. Wolf, D.V.M., Ph.D.

Introduction

Risk assessment is a process whereby the potential adverse health effects from exposure to a xenobiotic are predicted after evaluation of the availab...

Climate change and landscape development in post-closure safety assessment of solid radioactive waste disposal: Results of an initiative of the IAEA.

PubMed

Lindborg, T; Thorne, M; Andersson, E; Becker, J; Brandefelt, J; Cabianca, T; Gunia, M; Ikonen, A T K; Johansson, E; Kangasniemi, V; Kautsky, U; Kirchner, G; Klos, R; Kowe, R; Kontula, A; Kupiainen, P; Lahdenperä, A-M; Lord, N S; Lunt, D J; Näslund, J-O; Nordén, M; Norris, S; Pérez-Sánchez, D; Proverbio, A; Riekki, K; Rübel, A; Sweeck, L; Walke, R; Xu, S; Smith, G; Pröhl, G

2018-03-01

The International Atomic Energy Agency has coordinated an international project addressing climate change and landscape development in post-closure safety assessments of solid radioactive waste disposal. The work has been supported by results of parallel on-going research that has been published in a variety of reports and peer reviewed journal articles. The project is due to be described in detail in a forthcoming IAEA report. Noting the multi-disciplinary nature of post-closure safety assessments, here, an overview of the work is given to provide researchers in the broader fields of radioecology and radiological safety assessment with a review of the work that has been undertaken. It is hoped that such dissemination will support and promote integrated understanding and coherent treatment of climate change and landscape development within an overall assessment process. The key activities undertaken in the project were: identification of the key processes that drive environmental change (mainly those associated with climate and climate change), and description of how a relevant future may develop on a global scale; development of a methodology for characterising environmental change that is valid on a global scale, showing how modelled global changes in climate can be downscaled to provide information that may be needed for characterising environmental change in site-specific assessments, and illustrating different aspects of the methodology in a number of case studies that show the evolution of site characteristics and the implications for the dose assessment models. Overall, the study has shown that quantitative climate and landscape modelling has now developed to the stage that it can be used to define an envelope of climate and landscape change scenarios at specific sites and under specific greenhouse-gas emissions assumptions that is suitable for use in quantitative post-closure performance assessments. These scenarios are not predictions of the future, but

Surrogate Safety Assessment Model (SSAM)--software user manual

DOT National Transportation Integrated Search

2008-05-01

This document presents guidelines for the installation and use of the Surrogate Safety Assessment Model (SSAM) software. For more information regarding the SSAM application, including discussion of theoretical background and the results of a series o...

A Framework for Assessment of Aviation Safety Technology Portfolios

NASA Technical Reports Server (NTRS)

Jones, Sharon M.; Reveley, Mary S.

2014-01-01

The programs within NASA's Aeronautics Research Mission Directorate (ARMD) conduct research and development to improve the national air transportation system so that Americans can travel as safely as possible. NASA aviation safety systems analysis personnel support various levels of ARMD management in their fulfillment of system analysis and technology prioritization as defined in the agency's program and project requirements. This paper provides a framework for the assessment of aviation safety research and technology portfolios that includes metrics such as projected impact on current and future safety, technical development risk and implementation risk. The paper also contains methods for presenting portfolio analysis and aviation safety Bayesian Belief Network (BBN) output results to management using bubble charts and quantitative decision analysis techniques.

AGRICULTURAL CHEMICAL SAFETY ASSESSMENT: A MULTISECTOR APPROACH TO THE MODERNIZATION OF HUMAN SAFETY REQUIREMENTS.

EPA Science Inventory

Better understanding of toxicological mechanisms, enhanced testing capabilities, and demands for more sophisticated data for safety and health risk assessment have generated international interest in improving the current testing paradigm for agricultural chemicals. To address th...

Safety Assessment of Alkyl Ethylhexanoates as Used in Cosmetics.

PubMed

Fiume, Monice; 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

2015-01-01

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 16 alkyl ethylhexanoates for use in cosmetics, concluding that these ingredients are safe in cosmetic formulations in the present practices of use and concentrations when formulated to be nonirritating. The alkyl ethylhexanoates primarily function as skin-conditioning agents in cosmetics. The highest concentration of use reported for any of the alkyl ethylhexanoates is 77.3% cetyl ethylhexanoate in rinse-off formulations used near the eye, and the highest leave-on use reported is 52% cetyl ethylhexanoate in lipstick formulations. The Panel reviewed available animal and clinical data related to these ingredients, and the similarities in structure, properties, functions, and uses of ingredients from previous CIR assessments on constituent alcohols that allowed for extrapolation of the available toxicological data to assess the safety of the entire group. © The Author(s) 2015.

Vaccine Safety

MedlinePlus

... Search Form Controls Cancel Submit Search The CDC Vaccine Safety Note: Javascript is disabled or is not ... CDC.gov . Recommend on Facebook Tweet Share Compartir Vaccine Adverse Events Reporting System (VAERS) New website and ...

Lecture Notes on Criticality Safety Validation Using MCNP & Whisper

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

Brown, Forrest B.; Rising, Michael Evan; Alwin, Jennifer Louise

Training classes for nuclear criticality safety, MCNP documentation. The need for, and problems surrounding, validation of computer codes and data area considered first. Then some background for MCNP & Whisper is given--best practices for Monte Carlo criticality calculations, neutron spectra, S(α,β) thermal neutron scattering data, nuclear data sensitivities, covariance data, and correlation coefficients. Whisper is computational software designed to assist the nuclear criticality safety analyst with validation studies with the Monte Carlo radiation transport package MCNP. Whisper's methodology (benchmark selection – C k's, weights; extreme value theory – bias, bias uncertainty; MOS for nuclear data uncertainty – GLLS) and usagemore » are discussed.« less

Assessment of insurance incentives for safety belt usage

DOT National Transportation Integrated Search

1983-05-12

This study assesses the feasibility of insurance companies to offer incentives, in the form of premium reductions or additional benefits, which would be effective in increasing safety belt usage. The insurance types considered in this report are auto...

Hazard Identification and Risk Assessment of Health and Safety Approach JSA (Job Safety Analysis) in Plantation Company

NASA Astrophysics Data System (ADS)

Sugarindra, Muchamad; Ragil Suryoputro, Muhammad; Tiya Novitasari, Adi

2017-06-01

Plantation company needed to identify hazard and perform risk assessment as an Identification of Hazard and Risk Assessment Crime and Safety which was approached by using JSA (Job Safety Analysis). The identification was aimed to identify the potential hazards that might be the risk of workplace accidents so that preventive action could be taken to minimize the accidents. The data was collected by direct observation to the workers concerned and the results were recorded on a Job Safety Analysis form. The data were as forklift operator, macerator worker, worker’s creeper, shredder worker, workers’ workshop, mechanical line worker, trolley cleaning workers and workers’ crepe decline. The result showed that shredder worker value was 30 and had the working level with extreme risk with the risk value range was above 20. So to minimize the accidents could provide Personal Protective Equipment (PPE) which were appropriate, information about health and safety, the company should have watched the activities of workers, and rewards for the workers who obey the rules that applied in the plantation.

Performance of Compiler-Assisted Memory Safety Checking

DTIC Science & Technology

2014-08-01

software developer has in mind a particular object to which the pointer should point, the intended referent. A memory access error occurs when an ac...Performance of Compiler-Assisted Memory Safety Checking David Keaton Robert C. Seacord August 2014 TECHNICAL NOTE CMU/SEI-2014-TN...based memory safety checking tool and the performance that can be achieved with two such tools whose source code is freely available. The note then

Dermal safety assessment of Arm & Hammer laundry products formulated for sensitive skin.

PubMed

Frederick, Douglas M; Vorwerk, Linda; Gupta, Archana; Ghassemi, Annahita

2017-09-01

product (Arm & Hammer Free & Clear) and other nonirritant controls. In the Wrist Band Wear test, exposure to laundered fabrics under exaggerated conditions gave similar results for the test and control products, with no objective signs of skin irritation, and no self-reported persistent adverse sensory effects. Very mild, transient and isolated sensory effects were noted in daily diaries by a small proportion of subjects, and were similar for the test and control products. The Safety In-Use tests evaluated 4-week exposure to product and laundered fabrics under realistic use conditions. There were no clinically objective signs of skin irritation, and reports of transitory, mild sensory effects were minimal and similar for the test and controls. A comprehensive skin safety program on a lightly scented sensitive skin laundry formulation (i.e. Arm & Hammer™ Sensitive Skin plus Skin-Friendly Fresh Scent) conducted among panels of self-assessed sensitive skin subjects demonstrated that the presence of a light fragrance did not adversely impact skin compatibility in any of the testing protocols when the product was compared to a similar product with no fragrance. The lightly fragranced product demonstrated overall skin compatibility and mildness when tested in a self-assessed sensitive skin population, and compared favorably to currently marketed sensitive skin products.

A Microbial Assessment Scheme to measure microbial performance of Food Safety Management Systems.

PubMed

Jacxsens, L; Kussaga, J; Luning, P A; Van der Spiegel, M; Devlieghere, F; Uyttendaele, M

2009-08-31

A Food Safety Management System (FSMS) implemented in a food processing industry is based on Good Hygienic Practices (GHP), Hazard Analysis Critical Control Point (HACCP) principles and should address both food safety control and assurance activities in order to guarantee food safety. One of the most emerging challenges is to assess the performance of a present FSMS. The objective of this work is to explain the development of a Microbial Assessment Scheme (MAS) as a tool for a systematic analysis of microbial counts in order to assess the current microbial performance of an implemented FSMS. It is assumed that low numbers of microorganisms and small variations in microbial counts indicate an effective FSMS. The MAS is a procedure that defines the identification of critical sampling locations, the selection of microbiological parameters, the assessment of sampling frequency, the selection of sampling method and method of analysis, and finally data processing and interpretation. Based on the MAS assessment, microbial safety level profiles can be derived, indicating which microorganisms and to what extent they contribute to food safety for a specific food processing company. The MAS concept is illustrated with a case study in the pork processing industry, where ready-to-eat meat products are produced (cured, cooked ham and cured, dried bacon).

Aligning the 3Rs with new paradigms in the safety assessment of chemicals.

PubMed

Burden, Natalie; Mahony, Catherine; Müller, Boris P; Terry, Claire; Westmoreland, Carl; Kimber, Ian

2015-04-01

There are currently several factors driving a move away from the reliance on in vivo toxicity testing for the purposes of chemical safety assessment. Progress has started to be made in the development and validation of non-animal methods. However, recent advances in the biosciences provide exciting opportunities to accelerate this process and to ensure that the alternative paradigms for hazard identification and risk assessment deliver lasting 3Rs benefits, whilst improving the quality and relevance of safety assessment. The NC3Rs, a UK-based scientific organisation which supports the development and application of novel 3Rs techniques and approaches, held a workshop recently which brought together over 20 international experts in the field of chemical safety assessment. The aim of this workshop was to review the current scientific, technical and regulatory landscapes, and to identify key opportunities towards reaching these goals. Here, we consider areas where further strategic investment will need to be focused if significant impact on 3Rs is to be matched with improved safety science, and why the timing is right for the field to work together towards an environment where we no longer rely on whole animal data for the accurate safety assessment of chemicals.

Mature Drivers: Traffic Safety Tips

DOT National Transportation Integrated Search

1996-01-01

This fact sheet, NHTSA Facts: Summer 1996, discusses safety tips for drivers aged 70 and older. It notes that mature drivers: rank lower in aggressive actions; tend to make necessary safety adjustments in their driving, based on their own experience;...

Terrain Safety Assessment in Support of the Mars Science Laboratory Mission

NASA Technical Reports Server (NTRS)

Kipp, Devin

2012-01-01

In August 2012, the Mars Science Laboratory (MSL) mission will pioneer the next generation of robotic Entry, Descent, and Landing (EDL) systems by delivering the largest and most capable rover to date to the surface of Mars. The process to select the MSL landing site took over five years and began with over 50 initial candidate sites from which four finalist sites were chosen. The four finalist sites were examined in detail to assess overall science merit, EDL safety, and rover traversability on the surface. Ultimately, the engineering assessments demonstrated a high level of safety and robustness at all four finalist sites and differences in the assessment across those sites were small enough that neither EDL safety nor rover traversability considerations could significantly discriminate among the final four sites. Thus the MSL landing site at Gale Crater was selected from among the four finalists primarily on the basis of science considerations.

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

Preliminary Marine Safety Risk Assessment, Brandon Road Lock and Dam Invasive Species Control Measures

DTIC Science & Technology

2016-12-01

i Classification | CG-926 RDC | author | audience | month year Preliminary Marine Safety Risk Assessment, Brandon Road Lock & Dam...No. 4. Title and Subtitle Preliminary Marine Safety Risk Assessment, Brandon Road Lock & Dam Invasive Species Control Measures 5. Report Date...safety due to proposed invasive species control measures located in the vicinity of the Brandon Road Lock and Dam (BRLD) Navigation Project on the

Safety Assessment of Multi Purpose Small Payload Rack(MSPR)

NASA Astrophysics Data System (ADS)

Mizutani, Yoshinobu; Takada, Satomi; Murata, Kosei; Ozawa, Daisaku; Kobayashi, Ryoji; Nakamura, Yasuhiro

2010-09-01

We are reporting summary of preliminary safety assessment for Multi Purpose Small Payload Rack(MSPR), which is one of the micro gravity experiment facilities that are being developed for the 2nd phase JEM utilization(JEM: Japanese Experiment Module) that will be launched on H-II Transfer Vehicle(HTV) 2nd flight in 2011. MSPR is used for multi-purpose micro-g experiment providing experimental spaces and work stations. MSPR has three experimental spaces; first, there is a space called Work Volume(WV) with capacity volume of approximately 350 litters, in which multiple resources including electricity, communication, and moving image functions can be used. Within this space, installation of devices can be done by simple, prompt attachment by Velcro and pins with high degree of flexibility. Second, there is Small Experiment Area(SEA), with capacity volume of approximately 70 litters, in which electricity, communication, and moving image functions can also be used in the same way as WV. These spaces protect experiment devices and specimens from contingent loads by the crewmembers. Third, there is Work Bench with area of 0.5 square meters, on which can be used for maintenance, inspection and data operations of installed devices, etc. This bench can be stored in the rack during contingency. Chamber for Combustion Experiment(CCE) that is planned to be installed in WV is a pressure-resistant experimental container that can be used to seal hazardous materials from combustion experiments. This CCE has double sealing design in chamber itself, which resist gas leakage under normal the temperature and pressure. Electricity, communication, moving image function can be used in the same way as WV. JAXA Phase 2 Safety Review Panel(SRP) has been held in April, 2010. For safety analysis of MSPR, hazards were identified based on Fault Tree Analysis methodology and then these hazards were classified into either eight ISS standard-type hazards or eight unique-type hazards that requires

Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 2-Domino Hazard Index and case study.

PubMed

Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

2008-12-15

The design of layout plans requires adequate assessment tools for the quantification of safety performance. The general focus of the present work is to introduce an inherent safety perspective at different points of the layout design process. In particular, index approaches for safety assessment and decision-making in the early stages of layout design are developed and discussed in this two-part contribution. Part 1 (accompanying paper) of the current work presents an integrated index approach for safety assessment of early plant layout. In the present paper (Part 2), an index for evaluation of the hazard related to the potential of domino effects is developed. The index considers the actual consequences of possible escalation scenarios and scores or ranks the subsequent accident propagation potential. The effects of inherent and passive protection measures are also assessed. The result is a rapid quantification of domino hazard potential that can provide substantial support for choices in the early stages of layout design. Additionally, a case study concerning selection among various layout options is presented and analyzed. The case study demonstrates the use and applicability of the indices developed in both parts of the current work and highlights the value of introducing inherent safety features early in layout design.

The impact of note taking style and note availability at retrieval on mock jurors' recall and recognition of trial information.

PubMed

Thorley, Craig; Baxter, Rebecca E; Lorek, Joanna

2016-01-01

Jurors forget critical trial information and what they do recall can be inaccurate. Jurors' recall of trial information can be enhanced by permitting them to take notes during a trial onto blank sheets of paper (henceforth called freestyle note taking). A recent innovation is the trial-ordered-notebook (TON) for jurors, which is a notebook containing headings outlining the trial proceedings and which has space beneath each heading for notes. In a direct comparison, TON note takers recalled more trial information than freestyle note takers. This study investigated whether or not note taking improves recall as a result of enhanced encoding or as a result of note access at retrieval. To assess this, mock jurors watched and freely recalled a trial video with one-fifth taking no notes, two-fifths taking freestyle notes and two-fifths using TONs. During retrieval, half of the freestyle and TON note takers could access their notes. Note taking enhanced recall, with the freestyle note takers and TON note takers without note access performing equally as well. Note taking therefore enhances encoding. Recall was greatest for the TON note takers with note access, suggesting a retrieval enhancement unique to this condition. The theoretical and applied implications of these findings are discussed.

International Harmonization of Food Safety Assessment of Pesticide Residues.

PubMed

Ambrus, Árpád

2016-01-13

This paper summarizes the development of principles and methods applied within the program of the FAO/WHO Codex Alimentarius during the past 50 years for the safety assessment of pesticide residues in food and feed and establishing maximum residue limits (MRLs) to promote free international trade and assure the safety of consumers. The role of major international organizations in this process, the FAO capacity building activities, and some problematic areas that require special attention are briefly described.

Food Safety Practices Assessment Tool: An Innovative Way to Test Food Safety Skills among Individuals with Special Needs

ERIC Educational Resources Information Center

Carbone, Elena T.; Scarpati, Stanley E.; Pivarnik, Lori F.

2013-01-01

This article describes an innovative assessment tool designed to evaluate the effectiveness of a food safety skills curriculum for learners receiving special education services. As schools respond to the increased demand for training students with special needs about food safety, the need for effective curricula and tools is also increasing. A…

Flightdeck Automation Problems (FLAP) Model for Safety Technology Portfolio Assessment

NASA Technical Reports Server (NTRS)

Ancel, Ersin; Shih, Ann T.

2014-01-01

NASA's Aviation Safety Program (AvSP) develops and advances methodologies and technologies to improve air transportation safety. The Safety Analysis and Integration Team (SAIT) conducts a safety technology portfolio assessment (PA) to analyze the program content, to examine the benefits and risks of products with respect to program goals, and to support programmatic decision making. The PA process includes systematic identification of current and future safety risks as well as tracking several quantitative and qualitative metrics to ensure the program goals are addressing prominent safety risks accurately and effectively. One of the metrics within the PA process involves using quantitative aviation safety models to gauge the impact of the safety products. This paper demonstrates the role of aviation safety modeling by providing model outputs and evaluating a sample of portfolio elements using the Flightdeck Automation Problems (FLAP) model. The model enables not only ranking of the quantitative relative risk reduction impact of all portfolio elements, but also highlighting the areas with high potential impact via sensitivity and gap analyses in support of the program office. Although the model outputs are preliminary and products are notional, the process shown in this paper is essential to a comprehensive PA of NASA's safety products in the current program and future programs/projects.

Opportunities to Apply the 3Rs in Safety Assessment Programs

PubMed Central

Sewell, Fiona; Edwards, Joanna; Prior, Helen; Robinson, Sally

2016-01-01

Abstract Before a potential new medicine can be administered to humans it is essential that its safety is adequately assessed. Safety assessment in animals forms an integral part of this process, from early drug discovery and initial candidate selection to the program of recommended regulatory tests in animals. The 3Rs (replacement, reduction, and refinement of animals in research) are integrated in the current regulatory requirements and expectations and, in the EU, provide a legal and ethical framework for in vivo research to ensure the scientific objectives are met whilst minimizing animal use and maintaining high animal welfare standards. Though the regulations are designed to uncover potential risks, they are intended to be flexible, so that the most appropriate approach can be taken for an individual product. This article outlines current and future opportunities to apply the 3Rs in safety assessment programs for pharmaceuticals, and the potential (scientific, financial, and ethical) benefits to the industry, across the drug discovery and development process. For example, improvements to, or the development of, novel, early screens (e.g., in vitro, in silico, or nonmammalian screens) designed to identify compounds with undesirable characteristics earlier in development have the potential to reduce late-stage attrition by improving the selection of compounds that require regulatory testing in animals. Opportunities also exist within the current regulatory framework to simultaneously reduce and/or refine animal use and improve scientific outcomes through improvements to technical procedures and/or adjustments to study designs. It is important that approaches to safety assessment are continuously reviewed and challenged to ensure they are science-driven and predictive of relevant effects in humans. PMID:28053076

Assessment of patient safety culture in Palestinian public hospitals.

PubMed

Hamdan, Motasem; Saleem, Abed Alra'oof

2013-04-01

To assess the prevalent patient safety culture in Palestinian public hospitals. A cross-sectional design, Arabic translated version of the Hospital Survey on Patient Safety Culture was used. All the 11 general public hospitals in the West Bank. A total of 1460 clinical and non-clinical hospital staff. No. Twelve patient safety culture composites and 2 outcome variables (patient safety grade and events reported in the past year) were measured. Most of the participants were nurses and physicians (69.2%) with direct contact with patients (92%), mainly employed in medical/surgical units (55.1%). The patient safety composites with the highest positive scores were teamwork within units (71%), organizational learning and continuous improvement (62%) and supervisor/manager expectations and actions promoting patient safety (56%). The composites with the lowest scores were non-punitive response to error (17%), frequency of events reported (35%), communication openness (36%), hospital management support for patient safety (37%) and staffing (38%). Although 53.2% of the respondents did not report any event in the past year, 63.5% rated patient safety level as 'excellent/very good'. Significant differences in patient safety scores and outcome variables were found between hospitals of different size and in relation to staff positions and work hours. This study highlights the existence of a punitive and blame culture, under-reporting of events, lack of communication openness and inadequate management support that are key challenges for patient safe hospital care. The baseline survey results are valuable for designing and implementing the patient safety program and for measuring future progress.

A Systematic Review of the Safety and Efficacy of Mesenchymal Stem Cells for Disc Degeneration: Insights and Future Directions for Regenerative Therapeutics

PubMed Central

Yim, Rita Lok-Hay; Lee, Juliana Tsz-Yan; Bow, Cora H.; Meij, Björn; Leung, Victor; Cheung, Kenneth M.C.; Vavken, Patrick

2014-01-01

Intervertebral disc degeneration is associated with low-back pain. Mesenchymal stem cells (MSCs) have been used to “regenerate” the disc. The aim of this study was to perform a systematic review of comparative controlled studies that have assessed the safety and efficacy of using MSCs for disc regeneration. Literature databases were extensively searched. Trial design, subject-type, MSC sources, injection method, disc assessment, outcome intervals, and complication events were assessed. Validity of each study was performed. Twenty-four animal studies were included with 20.8% of the studies reporting randomization of groups. Trials in humans fulfilling inclusion criteria were not noted. The studies represented 862 discs that were injected with MSCs and 1,603 discs as controls. All three types of MSCs (ie, bone marrow, synovial, and adipose tissues) showed successful inhibition of disc degeneration. Bone-marrow-derived MSCs demonstrated superior quality of repair compared with other non-MSC treatments. A 2.7% overall complication rate was noted, whereby complications were noted only in rabbits. Overall, evidence suggested that MSCs increased disc space height in the majority of animal models. This is the first systematic review to assess the safety and efficacy of MSCs for the treatment of disc degeneration. Short-term MSC transplantation is safe and effective; however, additional, larger, and higher-quality studies are needed to assess the long-term safety and efficacy. Inconsistencies in methodological design and outcome parameters prevent any robust conclusions. Human-based clinical trials are needed. Recommendations are further made to improve efficacy, reduce potential complications, and standardize techniques for future studies. PMID:25050446

Simulating Geriatric Home Safety Assessments in a Three-Dimensional Virtual World

ERIC Educational Resources Information Center

Andrade, Allen D.; Cifuentes, Pedro; Mintzer, Michael J.; Roos, Bernard A.; Anam, Ramanakumar; Ruiz, Jorge G.

2012-01-01

Virtual worlds could offer inexpensive and safe three-dimensional environments in which medical trainees can learn to identify home safety hazards. Our aim was to evaluate the feasibility, usability, and acceptability of virtual worlds for geriatric home safety assessments and to correlate performance efficiency in hazard identification with…

The in-depth safety assessment (ISA) pilot projects in Ukraine.

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

Kot, C. A.

1998-02-10

Ukraine operates pressurized water reactors of the Soviet-designed type, VVER. All Ukrainian plants are currently operating with annually renewable permits until they update their safety analysis reports (SARs). After approval of the SARS by the Ukrainian Nuclear Regulatory Authority, the plants will be granted longer-term operating licenses. In September 1995, the Nuclear Regulatory Authority and the Government Nuclear Power Coordinating Committee of Ukraine issued a new contents requirement for the safety analysis reports of VVERs in Ukraine. It contains requirements in three major areas: design basis accident (DBA) analysis, probabilistic risk assessment (PRA), and beyond design-basis accident (BDBA) analysis. Themore » DBA requirements are an expanded version of the older SAR requirements. The last two requirements, on PRA and BDBA, are new. The US Department of Energy (USDOE), through the International Nuclear Safety Program (INSP), has initiated an assistance and technology transfer program to Ukraine to assist their nuclear power stations in developing a Western-type technical basis for the new SARS. USDOE sponsored In-Depth Safety Assessments (ISAs) have been initiated at three pilot nuclear reactor units in Ukraine, South Ukraine Unit 1, Zaporizhzhya Unit 5, and Rivne Unit 1. USDOE/INSP have structured the ISA program in such a way as to provide maximum assistance and technology transfer to Ukraine while encouraging and supporting the Ukrainian plants to take the responsibility and initiative and to perform the required assessments.« less

Portable Nanoparticle-Based Sensors for Food Safety Assessment

PubMed Central

Bülbül, Gonca; Hayat, Akhtar; Andreescu, Silvana

2015-01-01

The use of nanotechnology-derived products in the development of sensors and analytical measurement methodologies has increased significantly over the past decade. Nano-based sensing approaches include the use of nanoparticles (NPs) and nanostructures to enhance sensitivity and selectivity, design new detection schemes, improve sample preparation and increase portability. This review summarizes recent advancements in the design and development of NP-based sensors for assessing food safety. The most common types of NPs used to fabricate sensors for detection of food contaminants are discussed. Selected examples of NP-based detection schemes with colorimetric and electrochemical detection are provided with focus on sensors for the detection of chemical and biological contaminants including pesticides, heavy metals, bacterial pathogens and natural toxins. Current trends in the development of low-cost portable NP-based technology for rapid assessment of food safety as well as challenges for practical implementation and future research directions are discussed. PMID:26690169

Planning the Unplanned Experiment: Assessing the Efficacy of Standards for Safety Critical Software

NASA Technical Reports Server (NTRS)

Graydon, Patrick J.; Holloway, C. Michael

2015-01-01

We need well-founded means of determining whether software is t for use in safety-critical applications. While software in industries such as aviation has an excellent safety record, the fact that software aws have contributed to deaths illustrates the need for justi ably high con dence in software. It is often argued that software is t for safety-critical use because it conforms to a standard for software in safety-critical systems. But little is known about whether such standards `work.' Reliance upon a standard without knowing whether it works is an experiment; without collecting data to assess the standard, this experiment is unplanned. This paper reports on a workshop intended to explore how standards could practicably be assessed. Planning the Unplanned Experiment: Assessing the Ecacy of Standards for Safety Critical Software (AESSCS) was held on 13 May 2014 in conjunction with the European Dependable Computing Conference (EDCC). We summarize and elaborate on the workshop's discussion of the topic, including both the presented positions and the dialogue that ensued.

Making the message meaningful: a qualitative assessment of media promoting all-terrain vehicle safety.

PubMed

Brann, Maria; Mullins, Samantha Hope; Miller, Beverly K; Eoff, Shane; Graham, James; Aitken, Mary E

2012-08-01

Millions of all-terrain vehicles (ATV) are used around the world for recreation by both adults and youth. This increase in use has led to a substantial increase in the number of injuries and fatalities each year. Effective strategies for reducing this incidence are clearly needed; however, minimal research exists regarding effective educational interventions. This study was designed to assess rural ATV riders' preferences for and assessment of safety messages. 13 focus group discussions with youth and adult ATV riders were conducted. 88 formative research participants provided feedback on existing ATV safety materials, which was used to develop more useful ATV safety messages. 60 evaluative focus group participants critiqued the materials developed for this project. Existing ATV safety materials have limited effectiveness, in part because they may not address the content or design needs of the target population. ATV riders want educational and action-oriented safety messages that inform youth and adult riders about their responsibilities to learn, educate and implement safety behaviours (eg, appropriate-sized ATV, safety gear, solo riding, speed limits, riding locations). In addition, messages should be clear, realistic, visually appealing and easily accessible. Newly designed ATV safety materials using the acronym TRIPSS (training, ride off-road, impairment, plan ahead, safety gear, single rider) meet ATV riders' safety messaging needs. To reach a target population, it is crucial to include them in the development and assessment of safety messages. Germane to this particular study, ATV riders provided essential information for creating useful ATV safety materials.

LNG safety assessment evaluation methods : task 3 letter report.

DOT National Transportation Integrated Search

2016-07-01

Sandia National Laboratories evaluated published safety assessment methods across a variety of industries including Liquefied Natural Gas (LNG), hydrogen, land and marine transportation, as well as the US Department of Defense (DOD). All the methods ...

VA OpenNotes: exploring the experiences of early patient adopters with access to clinical notes.

PubMed

Nazi, Kim M; Turvey, Carolyn L; Klein, Dawn M; Hogan, Timothy P; Woods, Susan S

2015-03-01

To explore the experience of early patient adopters who accessed their clinical notes online using the Blue Button feature of the My HealtheVet portal. A web-based survey of VA patient portal users from June 22 to September 15, 2013. 33.5% of respondents knew that clinical notes could be viewed, and nearly one in four (23.5%) said that they had viewed their notes at least once. The majority of VA Notes users agreed that accessing their notes will help them to do a better job of taking medications as prescribed (80.1%) and be better prepared for clinic visits (88.6%). Nine out of 10 users agreed that use of visit notes will help them understand their conditions better (91.8%), and better remember the plan for their care (91.9%). In contrast, 87% disagreed that VA Notes will make them worry more, and 88.4% disagreed that access to VA Notes will be more confusing than helpful. Users who had either contacted their provider or healthcare team (11.9%) or planned to (13.5%) primarily wanted to learn more about a health issue, medication, or test results (53.7%). Initial assessment of the patient experience within the first 9 months of availability provides evidence that patients both value and benefit from online access to clinical notes. These findings are congruent with OpenNotes study findings on a broader scale. Additional outreach and education is needed to enhance patient awareness. Healthcare professionals should author notes keeping in mind the opportunity patient access presents for enhanced communication. © The Author 2014. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Safety assessment of GM plants: An updated review of the scientific literature.

PubMed

Domingo, José L

2016-09-01

In a wide revision of the literature conducted in 2000, I noted that the information in scientific journals on the safety of genetically modified (GM) foods in general, and GM plants in particular, was scarce. Of course, it was not sufficient to guarantee that the consumption of these products should not mean risks for the health of the consumers. Because of the scientific interest in GM organisms (GMOs), as well as the great concern that the consumption of GM foods/plants has raised in a number of countries, I conducted two subsequent revisions (2007 and 2011) on the adverse/toxic effects of GM plants. In the present review, I have updated the information on the potential adverse health effects of GM plants consumed as food and/or feed. With only a few exceptions, the reported studies in the last six years show rather similar conclusions; that is to say, the assessed GM soybeans, rice, corn/maize and wheat would be as safe as the parental species of these plants. However, in spite of the notable increase in the available information, studies on the long-term health effects of GM plants, including tests of mutagenicity, teratogenicity and carcinogenicity seem to be still clearly necessary. Copyright © 2016 Elsevier Ltd. All rights reserved.

Assessing medical students' perceptions of patient safety: the medical student safety attitudes and professionalism survey.

PubMed

Liao, Joshua M; Etchegaray, Jason M; Williams, S Tyler; Berger, David H; Bell, Sigall K; Thomas, Eric J

2014-02-01

To develop and test the psychometric properties of a survey to measure students' perceptions about patient safety as observed on clinical rotations. In 2012, the authors surveyed 367 graduating fourth-year medical students at three U.S. MD-granting medical schools. They assessed the survey's reliability and construct and concurrent validity. They examined correlations between students' perceptions of organizational cultural factors, organizational patient safety measures, and students' intended safety behaviors. They also calculated percent positive scores for cultural factors. Two hundred twenty-eight students (62%) responded. Analyses identified five cultural factors (teamwork culture, safety culture, error disclosure culture, experiences with professionalism, and comfort expressing professional concerns) that had construct validity, concurrent validity, and good reliability (Cronbach alphas > 0.70). Across schools, percent positive scores for safety culture ranged from 28% (95% confidence interval [CI], 13%-43%) to 64% (30%-98%), while those for teamwork culture ranged from 47% (32%-62%) to 74% (66%-81%). They were low for error disclosure culture (range: 10% [0%-20%] to 27% [20%-35%]), experiences with professionalism (range: 7% [0%-15%] to 23% [16%-30%]), and comfort expressing professional concerns (range: 17% [5%-29%] to 38% [8%-69%]). Each cultural factor correlated positively with perceptions of overall patient safety as observed in clinical rotations (r = 0.37-0.69, P < .05) and at least one safety behavioral intent item. This study provided initial evidence for the survey's reliability and validity and illustrated its applicability for determining whether students' clinical experiences exemplify positive patient safety environments.

Safety risk assessment using analytic hierarchy process (AHP) during planning and budgeting of construction projects.

PubMed

Aminbakhsh, Saman; Gunduz, Murat; Sonmez, Rifat

2013-09-01

The inherent and unique risks on construction projects quite often present key challenges to contractors. Health and safety risks are among the most significant risks in construction projects since the construction industry is characterized by a relatively high injury and death rate compared to other industries. In construction project management, safety risk assessment is an important step toward identifying potential hazards and evaluating the risks associated with the hazards. Adequate prioritization of safety risks during risk assessment is crucial for planning, budgeting, and management of safety related risks. In this paper, a safety risk assessment framework is presented based on the theory of cost of safety (COS) model and the analytic hierarchy process (AHP). The main contribution of the proposed framework is that it presents a robust method for prioritization of safety risks in construction projects to create a rational budget and to set realistic goals without compromising safety. The framework provides a decision tool for the decision makers to determine the adequate accident/injury prevention investments while considering the funding limits. The proposed safety risk framework is illustrated using a real-life construction project and the advantages and limitations of the framework are discussed. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

A Practical Risk Assessment Methodology for Safety-Critical Train Control Systems

DOT National Transportation Integrated Search

2009-07-01

This project proposes a Practical Risk Assessment Methodology (PRAM) for analyzing railroad accident data and assessing the risk and benefit of safety-critical train control systems. This report documents in simple steps the algorithms and data input...

Safety assessment of foods from genetically modified crops in countries with developing economies.

PubMed

Delaney, Bryan

2015-12-01

Population growth particularly in countries with developing economies will result in a need to increase food production by 70% by the year 2050. Biotechnology has been utilized to produce genetically modified (GM) crops for insect and weed control with benefits including increased crop yield and will also be used in emerging countries. A multicomponent safety assessment paradigm has been applied to individual GM crops to determine whether they as safe as foods from non-GM crops. This paper reviews methods to assess the safety of foods from GM crops for safe consumption from the first generation of GM crops. The methods can readily be applied to new products developed within country and this paper will emphasize the concept of data portability; that safety data produced in one geographic location is suitable for safety assessment regardless of where it is utilized. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Use of evidential reasoning and AHP to assess regional industrial safety.

PubMed

Chen, Zhichao; Chen, Tao; Qu, Zhuohua; Yang, Zaili; Ji, Xuewei; Zhou, Yi; Zhang, Hui

2018-01-01

China's fast economic growth contributes to the rapid development of its urbanization process, and also renders a series of industrial accidents, which often cause loss of life, damage to property and environment, thus requiring the associated risk analysis and safety control measures to be implemented in advance. However, incompleteness of historical failure data before the occurrence of accidents makes it difficult to use traditional risk analysis approaches such as probabilistic risk analysis in many cases. This paper aims to develop a new methodology capable of assessing regional industrial safety (RIS) in an uncertain environment. A hierarchical structure for modelling the risks influencing RIS is first constructed. The hybrid of evidential reasoning (ER) and Analytical Hierarchy Process (AHP) is then used to assess the risks in a complementary way, in which AHP is hired to evaluate the weight of each risk factor and ER is employed to synthesise the safety evaluations of the investigated region(s) against the risk factors from the bottom to the top level in the hierarchy. The successful application of the hybrid approach in a real case analysis of RIS in several major districts of Beijing (capital of China) demonstrates its feasibility as well as provides risk analysts and safety engineers with useful insights on effective solutions to comprehensive risk assessment of RIS in metropolitan cities. The contribution of this paper is made by the findings on the comparison of risk levels of RIS at different regions against various risk factors so that best practices from the good performer(s) can be used to improve the safety of the others.

46 CFR 62.25-15 - Safety control systems.

Code of Federal Regulations, 2011 CFR

2011-10-01

....35-50. Note: Safety control systems include automatic and manual safety trip controls and automatic... engines. (e) Automatic safety trip control systems must— (1) Be provided where there is an immediate... 46 Shipping 2 2011-10-01 2011-10-01 false Safety control systems. 62.25-15 Section 62.25-15...

Safety assessment in the urban park environment in Alborz Province, Iran.

PubMed

Oostakhan, Morteza; Babaei, Aliakbar

2013-01-01

Urban parks, as one of the recreational and sports sectors, could cause serious injuries among different ages if the safety issues in their design are not considered. These injuries can result from the equipment in the park, including play and sports equipment, or even from environmental factors, too. Lack of safety benchmark in parks will impact on the development of future proposals. In this article, attempts are made to survey the important safety factors in the urban parks including playgrounds, fitness equipment, pedestrian surface and environmental factors into a risk assessment. Hence, a checklist of safety factors was used. A Yes or No descriptor was allocated to any factor for determining safety level. The study also suggests recommendations for future planning concerning existing failures for designers. It was found that the safety level of the regional and local parks differ from each other.

Food and Feed Safety Assessment: The Importance of Proper Sampling.

PubMed

Kuiper, Harry A; Paoletti, Claudia

2015-03-24

The general principles for safety and nutritional evaluation of foods and feed and the potential health risks associated with hazardous compounds are described as developed by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) and further elaborated in the European Union-funded project Safe Foods. We underline the crucial role of sampling in foods/feed safety assessment. High quality sampling should always be applied to ensure the use of adequate and representative samples as test materials for hazard identification, toxicological and nutritional characterization of identified hazards, as well as for estimating quantitative and reliable exposure levels of foods/feed or related compounds of concern for humans and animals. The importance of representative sampling is emphasized through examples of risk analyses in different areas of foods/feed production. The Theory of Sampling (TOS) is recognized as the only framework within which to ensure accuracy and precision of all sampling steps involved in the field-to-fork continuum, which is crucial to monitor foods and feed safety. Therefore, TOS must be integrated in the well-established FAO/WHO risk assessment approach in order to guarantee a transparent and correct frame for the risk assessment and decision making process.

Food and feed safety assessment: the importance of proper sampling.

PubMed

Kuiper, Harry A; Paoletti, Claudia

2015-01-01

The general principles for safety and nutritional evaluation of foods and feed and the potential health risks associated with hazardous compounds are described as developed by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) and further elaborated in the European Union-funded project Safe Foods. We underline the crucial role of sampling in foods/feed safety assessment. High quality sampling should always be applied to ensure the use of adequate and representative samples as test materials for hazard identification, toxicological and nutritional characterization of identified hazards, as well as for estimating quantitative and reliable exposure levels of foods/feed or related compounds of concern for humans and animals. The importance of representative sampling is emphasized through examples of risk analyses in different areas of foods/feed production. The Theory of Sampling (TOS) is recognized as the only framework within which to ensure accuracy and precision of all sampling steps involved in the field-to-fork continuum, which is crucial to monitor foods and feed safety. Therefore, TOS must be integrated in the well-established FAO/WHO risk assessment approach in order to guarantee a transparent and correct frame for the risk assessment and decision making process.

Development and application of a safety assessment methodology for waste disposals

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

Little, R.H.; Torres, C.; Schaller, K.H.

1996-12-31

As part of a European Commission funded research programme, QuantiSci (formerly the Environmental Division of Intera Information Technologies) and Instituto de Medio Ambiente of the Centro de Investigaciones Energeticas Medioambientales y Tecnologicas (IMA/CIEMAT) have developed and applied a comprehensive, yet practicable, assessment methodology for post-disposal safety assessment of land-based disposal facilities. This Safety Assessment Comparison (SACO) Methodology employs a systematic approach to the collection, evaluation and use of waste and disposal system data. It can be used to assess engineered barrier performance, the attenuating properties of host geological formations, and the long term impacts of a facility on the environmentmore » and human health, as well as allowing the comparison of different disposal options for radioactive, mixed and non-radioactive wastes. This paper describes the development of the methodology and illustrates its use.« less

Addressing Problem Behavior at Recess Using Peer Praise Notes

ERIC Educational Resources Information Center

Teerlink, Elise; Caldarella, Paul; Anderson, Darlene H.; Richardson, Michael J.; Guzman, E. Geovanni

2017-01-01

School recess, though beneficial to students in many ways, can be a problematic setting due to inadequate supervision, structure, and safety. A peer praise note (PPN) intervention was implemented on the recess playground to address these concerns at a Title I elementary school. Researchers used a single-subject reversal design across all students…

Biomarkers: Dynamic "Tools" for Health and Safety Risk Assessment

EPA Science Inventory

Today informational flow from biomarkers contributes importantly to various types of health effects research, risk assessment and risk management decisions that impact, or have the potential to impact, public health and safety. Therefore, dependent upon the nature of the health r...

Safety Assessment for a Surface Repository in the Chernobyl Exclusion Zone - Methodology for Assessing Disposal under Intervention Conditions - 13476

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

Haverkamp, B.; Krone, J.; Shybetskyi, I.

The Radioactive Waste Disposal Facility (RWDF) Buryakovka was constructed in 1986 as part of the intervention measures after the accident at Chernobyl NPP (ChNPP). Today, RWDF Buryakovka is still being operated but its maximum capacity is nearly reached. Plans for enlargement of the facility exist since more than 10 years but have not been implemented yet. In the framework of an European Commission Project DBE Technology GmbH prepared a safety analysis report of the facility in its current state (SAR) and a preliminary safety analysis report (PSAR) based on the planned enlargement. Due to its history RWDF Buryakovka does notmore » fully comply with today's best international practices and the latest Ukrainian regulations in this area. The most critical aspects are its inventory of long-lived radionuclides, and the non-existent multi-barrier waste confinement system. A significant part of the project was dedicated, therefore, to the development of a methodology for the safety assessment taking into consideration the facility's special situation and to reach an agreement with all stakeholders involved in the later review and approval procedure of the safety analysis reports. Main aspect of the agreed methodology was to analyze the safety, not strictly based on regulatory requirements but on the assessment of the actual situation of the facility including its location within the Exclusion Zone. For both safety analysis reports, SAR and PSAR, the assessment of the long-term safety led to results that were either within regulatory limits or within the limits allowing for a specific situational evaluation by the regulator. (authors)« less

Urban transport safety assessment in akure based on corresponding performance indicators

NASA Astrophysics Data System (ADS)

Oye, Adedamola; Aderinlewo, Olufikayo; Croope, Silvana

2013-03-01

The level of safety of the transportation system in Akure, Nigeria was assessed by identifying the associated road safety problems and developing the corresponding safety performance indicators. These indicators were analysed with respect to accidents that occurred within the city from the year 2005 to 2009 based on the corresponding attributable risk measures. The results of the analysis showed the state of existing safety programs in Akure town. Six safety performance indicators were identified namely alcohol and drug use, excessive speeds, protection system (use of seat belts and helmets), use of day time running lights, state of vehicles (passive safety) and road condition. These indicators were used to determine the percentage of injury accidents as follows: 83.33% and 86.36% for years 2005 and 2006 respectively, 81.46% for year 2007 while years 2008 and 2009 had 82.86% and 78.12% injury accidents respectively.

Safety assessment in schools: beyond risk: the role of child psychiatrists and other mental health professionals.

PubMed

Rappaport, Nancy; Pollack, William S; Flaherty, Lois T; Schwartz, Sarah E O; McMickens, Courtney

2015-04-01

This article presents an overview of a comprehensive school safety assessment approach for students whose behavior raises concern about their potential for targeted violence. Case vignettes highlight the features of 2 youngsters who exemplify those seen, the comprehensive nature of the assessment, and the kind of recommendations that enhance a student's safety, connection, well-being; engage families; and share responsibility of assessing safety with the school. Copyright © 2015 Elsevier Inc. All rights reserved.

Use of evidential reasoning and AHP to assess regional industrial safety

PubMed Central

Chen, Zhichao; Chen, Tao; Qu, Zhuohua; Ji, Xuewei; Zhou, Yi; Zhang, Hui

2018-01-01

China’s fast economic growth contributes to the rapid development of its urbanization process, and also renders a series of industrial accidents, which often cause loss of life, damage to property and environment, thus requiring the associated risk analysis and safety control measures to be implemented in advance. However, incompleteness of historical failure data before the occurrence of accidents makes it difficult to use traditional risk analysis approaches such as probabilistic risk analysis in many cases. This paper aims to develop a new methodology capable of assessing regional industrial safety (RIS) in an uncertain environment. A hierarchical structure for modelling the risks influencing RIS is first constructed. The hybrid of evidential reasoning (ER) and Analytical Hierarchy Process (AHP) is then used to assess the risks in a complementary way, in which AHP is hired to evaluate the weight of each risk factor and ER is employed to synthesise the safety evaluations of the investigated region(s) against the risk factors from the bottom to the top level in the hierarchy. The successful application of the hybrid approach in a real case analysis of RIS in several major districts of Beijing (capital of China) demonstrates its feasibility as well as provides risk analysts and safety engineers with useful insights on effective solutions to comprehensive risk assessment of RIS in metropolitan cities. The contribution of this paper is made by the findings on the comparison of risk levels of RIS at different regions against various risk factors so that best practices from the good performer(s) can be used to improve the safety of the others. PMID:29795593

Assessment of contributions to patient safety knowledge by the Agency for Healthcare Research and Quality-funded patient safety projects.

PubMed

Sorbero, Melony E S; Ricci, Karen A; Lovejoy, Susan; Haviland, Amelia M; Smith, Linda; Bradley, Lily A; Hiatt, Liisa; Farley, Donna O

2009-04-01

To characterize the activities of projects funded in Agency for Healthcare Research and Quality (AHRQ)'s patient safety portfolio and assess their aggregate potential to contribute to knowledge development. Information abstracted from proposals for projects funded in AHRQ's patient safety portfolio, information on safety practices from the AHRQ Evidence Report on Patient Safety Practices, and products produced by the projects. This represented one part of the process evaluation conducted as part of a longitudinal evaluation based on the Context–Input–Process–Product model. The 234 projects funded through AHRQ's patient safety portfolio examined a wide variety of patient safety issues and extended their work beyond the hospital setting to less studied parts of the health care system. Many of the projects implemented and tested practices for which the patient safety evidence report identified a need for additional evidence. The funded projects also generated a substantial body of new patient safety knowledge through a growing number of journal articles and other products. The projects funded in AHRQ's patient safety portfolio have the potential to make substantial contributions to the knowledge base on patient safety. The full value of this new knowledge remains to be confirmed through the synthesis of results

VVER Reactor Safety in Eastern Europe and Former Soviet Union

NASA Astrophysics Data System (ADS)

Papadopoulou, Demetra

2012-02-01

VVER Soviet-designed reactors that operate in Eastern Europe and former Soviet republics have heightened international concern for years due to major safety deficiencies. The governments of countries with VVER reactors have invested millions of dollars toward improving the safety of their nuclear power plants. Most of these reactors will continue to operate for the foreseeable future since they provide urgently-needed electrical power. Given this situation, this paper assesses the radiological consequences of a major nuclear accident in Eastern Europe. The paper also chronicles the efforts launched by the international nuclear community to improve the safety of the reactors and notes the progress made so far through extensive collaborative efforts in Armenia, Bulgaria, the Czech Republic, Hungary, Kazakhstan, Lithuania, Russia, Slovakia, and Ukraine to reduce the risks of nuclear accidents. Western scientific and technical staff collaborated with these countries to improve the safety of their reactor operations by strengthening the ability of the regulator to perform its oversight function, installing safety equipment and technologies, investing time in safety training, and working diligently to establish an enduring safety culture. Still, continued safety improvement efforts are necessary to ensure safe operating practices and achieve timely phase-out of older plants.

Error disclosure: a new domain for safety culture assessment.

PubMed

Etchegaray, Jason M; Gallagher, Thomas H; Bell, Sigall K; Dunlap, Ben; Thomas, Eric J

2012-07-01

To (1) develop and test survey items that measure error disclosure culture, (2) examine relationships among error disclosure culture, teamwork culture and safety culture and (3) establish predictive validity for survey items measuring error disclosure culture. All clinical faculty from six health institutions (four medical schools, one cancer centre and one health science centre) in The University of Texas System were invited to anonymously complete an electronic survey containing questions about safety culture and error disclosure. The authors found two factors to measure error disclosure culture: one factor is focused on the general culture of error disclosure and the second factor is focused on trust. Both error disclosure culture factors were unique from safety culture and teamwork culture (correlations were less than r=0.85). Also, error disclosure general culture and error disclosure trust culture predicted intent to disclose a hypothetical error to a patient (r=0.25, p<0.001 and r=0.16, p<0.001, respectively) while teamwork and safety culture did not predict such an intent (r=0.09, p=NS and r=0.12, p=NS). Those who received prior error disclosure training reported significantly higher levels of error disclosure general culture (t=3.7, p<0.05) and error disclosure trust culture (t=2.9, p<0.05). The authors created and validated a new measure of error disclosure culture that predicts intent to disclose an error better than other measures of healthcare culture. This measure fills an existing gap in organisational assessments by assessing transparent communication after medical error, an important aspect of culture.

QNOTE: an instrument for measuring the quality of EHR clinical notes.

PubMed

Burke, Harry B; Hoang, Albert; Becher, Dorothy; Fontelo, Paul; Liu, Fang; Stephens, Mark; Pangaro, Louis N; Sessums, Laura L; O'Malley, Patrick; Baxi, Nancy S; Bunt, Christopher W; Capaldi, Vincent F; Chen, Julie M; Cooper, Barbara A; Djuric, David A; Hodge, Joshua A; Kane, Shawn; Magee, Charles; Makary, Zizette R; Mallory, Renee M; Miller, Thomas; Saperstein, Adam; Servey, Jessica; Gimbel, Ronald W

2014-01-01

The outpatient clinical note documents the clinician's information collection, problem assessment, and patient management, yet there is currently no validated instrument to measure the quality of the electronic clinical note. This study evaluated the validity of the QNOTE instrument, which assesses 12 elements in the clinical note, for measuring the quality of clinical notes. It also compared its performance with a global instrument that assesses the clinical note as a whole. Retrospective multicenter blinded study of the clinical notes of 100 outpatients with type 2 diabetes mellitus who had been seen in clinic on at least three occasions. The 300 notes were rated by eight general internal medicine and eight family medicine practicing physicians. The QNOTE instrument scored the quality of the note as the sum of a set of 12 note element scores, and its inter-rater agreement was measured by the intraclass correlation coefficient. The Global instrument scored the note in its entirety, and its inter-rater agreement was measured by the Fleiss κ. The overall QNOTE inter-rater agreement was 0.82 (CI 0.80 to 0.84), and its note quality score was 65 (CI 64 to 66). The Global inter-rater agreement was 0.24 (CI 0.19 to 0.29), and its note quality score was 52 (CI 49 to 55). The QNOTE quality scores were consistent, and the overall QNOTE score was significantly higher than the overall Global score (p=0.04). We found the QNOTE to be a valid instrument for evaluating the quality of electronic clinical notes, and its performance was superior to that of the Global instrument. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Assessment of commercial NLP engines for medication information extraction from dictated clinical notes.

PubMed

Jagannathan, V; Mullett, Charles J; Arbogast, James G; Halbritter, Kevin A; Yellapragada, Deepthi; Regulapati, Sushmitha; Bandaru, Pavani

2009-04-01

We assessed the current state of commercial natural language processing (NLP) engines for their ability to extract medication information from textual clinical documents. Two thousand de-identified discharge summaries and family practice notes were submitted to four commercial NLP engines with the request to extract all medication information. The four sets of returned results were combined to create a comparison standard which was validated against a manual, physician-derived gold standard created from a subset of 100 reports. Once validated, the individual vendor results for medication names, strengths, route, and frequency were compared against this automated standard with precision, recall, and F measures calculated. Compared with the manual, physician-derived gold standard, the automated standard was successful at accurately capturing medication names (F measure=93.2%), but performed less well with strength (85.3%) and route (80.3%), and relatively poorly with dosing frequency (48.3%). Moderate variability was seen in the strengths of the four vendors. The vendors performed better with the structured discharge summaries than with the clinic notes in an analysis comparing the two document types. Although automated extraction may serve as the foundation for a manual review process, it is not ready to automate medication lists without human intervention.

DEVELOPMENT OF ADME DATA IN AGRICULTURAL CHEMICAL SAFETY ASSESSMENTS

EPA Science Inventory

DEVELOPMENT OF ADME DATA IN AGRICULTURAL CHEMICAL SAFETY ASSESSMENTS
Pastoor, Timothy1, Barton, Hugh2
1 Syngenta Crop Protection, Greensboro, NC, USA.
2 EPA, Office of Research and Development-NHEERL, RTP, NC, USA.

A multi-stakeholder series of discussions d...

Real-Time Safety Risk Assessment Based on a Real-Time Location System for Hydropower Construction Sites

PubMed Central

Fan, Qixiang; Qiang, Maoshan

2014-01-01

The concern for workers' safety in construction industry is reflected in many studies focusing on static safety risk identification and assessment. However, studies on real-time safety risk assessment aimed at reducing uncertainty and supporting quick response are rare. A method for real-time safety risk assessment (RTSRA) to implement a dynamic evaluation of worker safety states on construction site has been proposed in this paper. The method provides construction managers who are in charge of safety with more abundant information to reduce the uncertainty of the site. A quantitative calculation formula, integrating the influence of static and dynamic hazards and that of safety supervisors, is established to link the safety risk of workers with the locations of on-site assets. By employing the hidden Markov model (HMM), the RTSRA provides a mechanism for processing location data provided by the real-time location system (RTLS) and analyzing the probability distributions of different states in terms of false positives and negatives. Simulation analysis demonstrated the logic of the proposed method and how it works. Application case shows that the proposed RTSRA is both feasible and effective in managing construction project safety concerns. PMID:25114958

Real-time safety risk assessment based on a real-time location system for hydropower construction sites.

PubMed

Jiang, Hanchen; Lin, Peng; Fan, Qixiang; Qiang, Maoshan

2014-01-01

The concern for workers' safety in construction industry is reflected in many studies focusing on static safety risk identification and assessment. However, studies on real-time safety risk assessment aimed at reducing uncertainty and supporting quick response are rare. A method for real-time safety risk assessment (RTSRA) to implement a dynamic evaluation of worker safety states on construction site has been proposed in this paper. The method provides construction managers who are in charge of safety with more abundant information to reduce the uncertainty of the site. A quantitative calculation formula, integrating the influence of static and dynamic hazards and that of safety supervisors, is established to link the safety risk of workers with the locations of on-site assets. By employing the hidden Markov model (HMM), the RTSRA provides a mechanism for processing location data provided by the real-time location system (RTLS) and analyzing the probability distributions of different states in terms of false positives and negatives. Simulation analysis demonstrated the logic of the proposed method and how it works. Application case shows that the proposed RTSRA is both feasible and effective in managing construction project safety concerns.

Safety Assessment and Biological Effects of a New Cold Processed SilEmulsion for Dermatological Purpose

PubMed Central

Salgado, Ana; Gonçalves, Lídia; Pinto, Pedro C.; Urbano, Manuela; Ribeiro, Helena M.

2013-01-01

It is of crucial importance to evaluate the safety profile of the ingredients used in dermatological emulsions. A suitable equilibrium between safety and efficacy is a pivotal concern before the marketing of a dermatological product. The aim was to assess the safety and biological effects of a new cold processed silicone-based emulsion (SilEmulsion). The hazard, exposure, and dose-response assessment were used to characterize the risk for each ingredient. EpiSkin assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data. The efficacy of the SilEmulsion was studied using biophysical measurements in human volunteers during 21 days. According to the safety assessment of the ingredients, 1,5-pentanediol was an ingredient of special concern since its margin of safety was below the threshold of 100 (36.53). EpiSkin assay showed that the tissue viability after the application of the SilEmulsion was 92 ± 6% and, thus considered nonirritant to the skin. The human studies confirmed that the SilEmulsion was not a skin irritant and did not induce any sensitization on the volunteers, being safe for human use. Moreover, biological effects demonstrated that the SilEmulsion increased both the skin hydration and skin surface lipids. PMID:24294598

Safety assessment and biological effects of a new cold processed SilEmulsion for dermatological purpose.

PubMed

Raposo, Sara; Salgado, Ana; Gonçalves, Lídia; Pinto, Pedro C; Urbano, Manuela; Ribeiro, Helena M

2013-01-01

It is of crucial importance to evaluate the safety profile of the ingredients used in dermatological emulsions. A suitable equilibrium between safety and efficacy is a pivotal concern before the marketing of a dermatological product. The aim was to assess the safety and biological effects of a new cold processed silicone-based emulsion (SilEmulsion). The hazard, exposure, and dose-response assessment were used to characterize the risk for each ingredient. EpiSkin assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data. The efficacy of the SilEmulsion was studied using biophysical measurements in human volunteers during 21 days. According to the safety assessment of the ingredients, 1,5-pentanediol was an ingredient of special concern since its margin of safety was below the threshold of 100 (36.53). EpiSkin assay showed that the tissue viability after the application of the SilEmulsion was 92 ± 6% and, thus considered nonirritant to the skin. The human studies confirmed that the SilEmulsion was not a skin irritant and did not induce any sensitization on the volunteers, being safe for human use. Moreover, biological effects demonstrated that the SilEmulsion increased both the skin hydration and skin surface lipids.

Environment, Safety and Health Self-Assessment Report Fiscal Year 2010

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

Robinson, Scott

2011-03-23

The Lawrence Berkeley National Laboratory (LBNL) Environment, Safety, and Health (ES&H) Self-Assessment Program was established to ensure that Integrated Safety Management (ISM) is implemented institutionally and by all divisions. The ES&H Self-Assessment Program, managed by the Office of Contractor Assurance (OCA), provides for an internal evaluation of all ES&H programs and systems at LBNL. The primary objective of the program is to ensure that work is conducted safely and with minimal negative impact to workers, the public, and the environment. Self-assessment follows the five core functions and guiding principles of ISM. Self-assessment is the mechanism used to promote the continuousmore » improvement of the Laboratory's ES&H programs. The process is described in the Environment, Safety, and Health Assurance Plan (PUB-5344) and is composed of three types of self-assessments: Division ES&H Self-Assessment, ES&H Technical Assurance Program Assessment, and Division ES&H Peer Review. The Division ES&H Self-Assessment Manual (PUB-3105) provides the framework by which divisions conduct formal ES&H self-assessments to systematically identify program deficiencies. Issue-specific assessments are designed and implemented by the divisions and focus on areas of interest to division management. They may be conducted by teams and involve advance planning to ensure that appropriate resources are available. The ES&H Technical Assurance Program Manual (PUB-913E) provides the framework for systematic reviews of ES&H programs and processes. The ES&H Technical Assurance Program Assessment is designed to evaluate whether ES&H programs and processes are compliant with guiding regulations, are effective, and are properly implemented by LBNL divisions. The Division ES&H Peer Review Manual provides the framework by which division ISM systems are evaluated and improved. Peer Reviews are conducted by teams under the direction of senior division management and focus on higher

Risk Assessment in the UK Health and Safety System: Theory and Practice.

PubMed

Russ, Karen

2010-09-01

In the UK, a person or organisation that creates risk is required to manage and control that risk so that it is reduced 'So Far As Is Reasonably Practicable' (SFAIRP). How the risk is managed is to be determined by those who create the risk. They have a duty to demonstrate that they have taken action to ensure all risk is reduced SFAIRP and must have documentary evidence, for example a risk assessment or safety case, to prove that they manage the risks their activities create. The UK Health and Safety Executive (HSE) does not tell organisations how to manage the risks they create but does inspect the quality of risk identification and management. This paper gives a brief overview of where responsibility for occupational health and safety lies in the UK, and how risk should be managed through risk assessment. The focus of the paper is three recent major UK incidents, all involving fatalities, and all of which were wholly avoidable if risks had been properly assessed and managed. The paper concludes with an analysis of the common failings of risk assessments and key actions for improvement.

Immunogenicity and safety assessment of a trivalent, inactivated split influenza vaccine in Korean children: Double-blind, randomized, active-controlled multicenter phase III clinical trial.

PubMed

Han, Seung Beom; Rhim, Jung-Woo; Shin, Hye Jo; Lee, Soo Young; Kim, Hyun-Hee; Kim, Jong-Hyun; Lee, Kyung-Yil; Ma, Sang Hyuk; Park, Joon Soo; Kim, Hwang Min; Kim, Chun Soo; Kim, Dong Ho; Choi, Young Youn; Cha, Sung-Ho; Hong, Young Jin; Kang, Jin Han

2015-01-01

A multicenter, double-blind, randomized, active-control phase III clinical trial was performed to assess the immunogenicity and safety of a trivalent, inactivated split influenza vaccine. Korean children between the ages of 6 months and 18 y were enrolled and randomized into a study (study vaccine) or a control vaccine group (commercially available trivalent, inactivated split influenza vaccine) in a 5:1 ratio. Antibody responses were determined using hemagglutination inhibition assay, and post-vaccination immunogenicity was assessed based on seroconversion and seroprotection rates. For safety assessment, solicited local and systemic adverse events up to 28 d after vaccination and unsolicited adverse events up to 6 months after vaccination were evaluated. Immunogenicity was assessed in 337 and 68 children of the study and control groups. In the study vaccine group, seroconversion rates against influenza A/H1N1, A/H3N2, and B strains were 62.0% (95% CI: 56.8-67.2), 53.4% (95% CI: 48.1-58.7), and 54.9% (95% CI: 48.1-60.2), respectively. The corresponding seroprotection rates were 95.0% (95% CI: 92.6-97.3), 93.8% (95% CI: 91.2-96.4), and 95.3% (95% CI: 93.0-97.5). The lower 95% CI limits of the seroconversion and seroprotection rates were over 40% and 70%, respectively, against all strains. Seroconversion and seroprotection rates were not significantly different between the study and control vaccine groups. Furthermore, the frequencies of adverse events were not significantly different between the 2 vaccine groups, and no serious vaccination-related adverse events were noted. In conclusion, the study vaccine exhibited substantial immunogenicity and safety in Korean children and is expected to be clinically effective.

The essential SOAP note in an EHR age.

PubMed

Pearce, Patricia F; Ferguson, Laurie Anne; George, Gwen S; Langford, Cynthia A

2016-02-18

This article reviews the traditional Subjective, Objective, Assessment, and Plan (SOAP) note documentation format. The information in the SOAP note is useful to both providers and students for history taking and physical exam, and highlights the importance of including critical documentation details with or without an electronic health record.

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.

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.

247. Axial Parkway alignment along ridge top. Note the open ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

247. Axial Parkway alignment along ridge top. Note the open vistas to either side of the roadway. These are maintained through vegetation management. The wood guide rail is a primary safety feature. View is to the northeast. - Blue Ridge Parkway, Between Shenandoah National Park & Great Smoky Mountains, Asheville, Buncombe County, NC

Assessing safety of herbal products for menopausal complaints: an international perspective.

PubMed

Dog, Tieraona Low; Marles, Robin; Mahady, Gail; Gardiner, Paula; Ko, Richard; Barnes, Jo; Chavez, Mary L; Griffiths, James; Giancaspro, Gabriel; Sarma, Nandakumara D

2010-08-01

Future research of herbal products for menopausal women should include long-term safety assessments because women may use these products for prolonged periods of time. Growing numbers of women take prescription medications and concurrently use herbal products for alleviation of menopausal symptoms. Because of possible herb-drug interactions, both drug and supplement manufacturers should provide basic pharmacokinetic data to reduce the risk of adverse interactions. In addition, herbal products produced to high quality standards are essential for ensuring consumer safety. Regulatory frameworks must be in place to ensure that herbal ingredients' identities have been verified, that they have been properly quantified per unit dose, that the product is within tolerance limits for contaminants, that the product's safety and effectiveness under the recommended conditions of use have been assessed before sale to the public, and that a system is in place to detect and deal with adverse reactions when they arise. This article explores these and related concerns. Copyright 2010. Published by Elsevier Ireland Ltd.

Safety Assessment of Alkyl PEG/PPG Ethers 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 (CIR) Expert Panel assessed the safety of 131 alkyl polyethylene glycol (PEG)/polypropylene glycol ethers as used in cosmetics, concluding that these ingredients are safe in the present practices of use and concentration described in this safety assessment when formulated to be nonirritating. Most of the alkyl PEG/PPG ethers included in this review are reported to function in cosmetics as surfactants, skin-conditioning agents, and/or emulsifying agents. The alkyl PEG/PPG ethers share very similar physiochemical properties as the alkyl PEG ethers, which were reviewed previously by the CIR Expert Panel and found safe when formulated to be nonirritating. The alkyl PEG ethers differ by the inclusion of PPG repeat units, which are used to fine-tune the surfactant properties of this group. The Panel relied heavily on data on analogous ingredients, extracted from the alkyl PEG ethers and PPG reports, when making its determination of safety. © The Author(s) 2016.

Taking Action: Navigating the Common Core State Standards and Assessments. Policy Notes. Volume 21, Number 2, Fall 2013

ERIC Educational Resources Information Center

Yaffe, Deborah

2013-01-01

This issue of ETS Policy Notes (Vol 21, No. 2) highlights the discussion from "Taking Action: Navigating the Common Core State Standards and Assessments," a conference co-convened by ETS and the National Urban League (NUL) in February 2013. Part of the Saturdays at ETS series, the conference brought together researchers, funders,…

Assessment of Contributions to Patient Safety Knowledge by the Agency for Healthcare Research and Quality-Funded Patient Safety Projects

PubMed Central

Sorbero, Melony E S; Ricci, Karen A; Lovejoy, Susan; Haviland, Amelia M; Smith, Linda; Bradley, Lily A; Hiatt, Liisa; Farley, Donna O

2009-01-01

Objective To characterize the activities of projects funded in Agency for Healthcare Research and Quality (AHRQ)' patient safety portfolio and assess their aggregate potential to contribute to knowledge development. Data Sources Information abstracted from proposals for projects funded in AHRQ' patient safety portfolio, information on safety practices from the AHRQ Evidence Report on Patient Safety Practices, and products produced by the projects. Study Design This represented one part of the process evaluation conducted as part of a longitudinal evaluation based on the Context–Input–Process–Product model. Principal Findings The 234 projects funded through AHRQ' patient safety portfolio examined a wide variety of patient safety issues and extended their work beyond the hospital setting to less studied parts of the health care system. Many of the projects implemented and tested practices for which the patient safety evidence report identified a need for additional evidence. The funded projects also generated a substantial body of new patient safety knowledge through a growing number of journal articles and other products. Conclusions The projects funded in AHRQ' patient safety portfolio have the potential to make substantial contributions to the knowledge base on patient safety. The full value of this new knowledge remains to be confirmed through the synthesis of results. PMID:21456108

Is there agreement between worker self and supervisor assessment of worker safety performance? An examination in the construction industry.

PubMed

Xia, Nini; Griffin, Mark A; Wang, Xueqing; Liu, Xing; Wang, Dan

2018-06-01

Individual safety performance (behavior) critically influences safety outcomes in high-risk workplaces. Compared to the study of generic work performance on different measurements, few studies have investigated different measurements of safety performance, typically relying on employees' self-reflection of their safety behavior. This research aims to address this limitation by including worker self-reflection and other (i.e., supervisor) assessment of two worker safety performance dimensions, safety compliance and safety participation. A sample of 105 workers and 17 supervisors in 17 groups in the Chinese construction industry participated in this study. Comparisons were made between worker compliance and participation in each measurement, and between workers' and supervisors' assessment of workers' compliance and participation. Multilevel modeling was adopted to test the moderating effects on the worker self-reflection and supervisor-assessment relationship by group safety climate and the work experience of supervisors. Higher levels of safety compliance than participation were found for self-reflection and supervisor assessment. The discrepancy between the two measurements in each safety performance dimension was significant. The work experience of supervisors attenuated the discrepancy between self- and supervisor-assessment of compliance. Contrary to our expectations, the moderating effect of group safety climate was not supported. The discrepancy between worker self- and supervisor-assessment of worker safety performance, thus, suggests the importance of including alternative measurements of safety performance in addition to self-reflection. Lower levels of participation behavior in both raters suggest more research on the motivators of participatory behavior. Practical applications The discrepancy between different raters can lead to negative reactions of ratees, suggesting that managers should be aware of that difference. Assigning experienced supervisors as

Guide for the Development of Safety Assessment Report (SAR)

DTIC Science & Technology

1987-08-01

Di ’:t ib ityioe I A,;!i~abiiity Codes Dist SpdIt ora bloe INSia OEapy r TABLE OF CONTENTS PAGE III SAFETY ASSESSMENT REPORT...above. Potential hazards associated with the maintenance of the turbine engine (i.e., use of cleaning agents ) are not addressed .in the accompanying

A probability-based approach for assessment of roadway safety hardware.

DOT National Transportation Integrated Search

2017-03-14

This report presents a general probability-based approach for assessment of roadway safety hardware (RSH). It was achieved using a reliability : analysis method and computational techniques. With the development of high-fidelity finite element (FE) m...

The School Assessment for Environmental Typology (SAfETy): An Observational Measure of the School Environment.

PubMed

Bradshaw, Catherine P; Milam, Adam J; Furr-Holden, C Debra M; Johnson, Sarah Lindstrom

2015-12-01

School safety is of great concern for prevention researchers, school officials, parents, and students, yet there are a dearth of assessments that have operationalized school safety from an organizational framework using objective tools and measures. Such a tool would be important for deriving unbiased assessments of the school environment, which in turn could be used as an evaluative tool for school violence prevention efforts. The current paper presents a framework for conceptualizing school safety consistent with Crime Prevention through Environmental Design (CPTED) model and social disorganization theory, both of which highlight the importance of context as a driver for adolescents' risk for involvement in substance use and violence. This paper describes the development of a novel observational measure, called the School Assessment for Environmental Typology (SAfETy), which applies CPTED and social disorganizational frameworks to schools to measure eight indicators of school physical and social environment (i.e., disorder, trash, graffiti/vandalism, appearance, illumination, surveillance, ownership, and positive behavioral expectations). Drawing upon data from 58 high schools, we provide preliminary data regarding the validity and reliability of the SAfETy and describe patterns of the school safety indicators. Findings demonstrate the reliability and validity of the SAfETy and are discussed with regard to the prevention of violence in schools.

Skin colour assessment of replanted fingers in digital images and its reliability for the incorporation of images in nursing progress notes.

PubMed

Terashima, Taiko; Yoshimura, Sadako

2018-03-01

To determine whether nurses can accurately assess the skin colour of replanted fingers displayed as digital images on a computer screen. Colour measurement and clinical diagnostic methods for medical digital images have been studied, but reproducing skin colour on a computer screen remains difficult. The inter-rater reliability of skin colour assessment scores was evaluated. In May 2014, 21 nurses who worked on a trauma ward in Japan participated in testing. Six digital images with different skin colours were used. Colours were scored from both digital images and direct patient's observation. The score from a digital image was defined as the test score, and its difference from the direct assessment score as the difference score. Intraclass correlation coefficients were calculated. Nurses' opinions were classified and summarised. The intraclass correlation coefficients for the test scores were fair. Although the intraclass correlation coefficients for the difference scores were poor, they improved to good when three images that might have contributed to poor reliability were excluded. Most nurses stated that it is difficult to assess skin colour in digital images; they did not think it could be a substitute for direct visual assessment. However, most nurses were in favour of including images in nursing progress notes. Although the inter-rater reliability was fairly high, the reliability of colour reproduction in digital images as indicated by the difference scores was poor. Nevertheless, nurses expect the incorporation of digital images in nursing progress notes to be useful. This gap between the reliability of digital colour reproduction and nurses' expectations towards it must be addressed. High inter-rater reliability for digital images in nursing progress notes was not observed. Assessments of future improvements in colour reproduction technologies are required. Further digitisation and visualisation of nursing records might pose challenges. © 2017 John Wiley

A measurement tool to assess culture change regarding patient safety in hospital obstetrical units.

PubMed

Kenneth Milne, J; Bendaly, Nicole; Bendaly, Leslie; Worsley, Jill; FitzGerald, John; Nisker, Jeff

2010-06-01

Clinical error in acute care hospitals can only be addressed by developing a culture of safety. We sought to develop a cultural assessment survey (CAS) to assess patient safety culture change in obstetrical units. Interview prompts and a preliminary questionnaire were developed through a literature review of patient safety and "high reliability organizations," followed by interviews with members of the Managing Obstetrical Risk Efficiently (MOREOB) Program of the Society of Obstetricians and Gynaecologists of Canada. Three hundred preliminary questionnaires were mailed, and 21 interviews and 9 focus groups were conducted with the staff of 11 hospital sites participating in the program. To pilot test the CAS, 350 surveys were mailed to staff in participating hospitals, and interviews were conducted with seven nurses and five physicians who had completed the survey. Reliability analysis was conducted on four units that completed the CAS prior to and following the implementation of the first MOREOB module. Nineteen values and 105 behaviours, practices, and perceptions relating to patient safety were identified and included in the preliminary questionnaire, of which 143 of 300 (47.4%) were returned. Among the 220 cultural assessment surveys returned (62.9%), six cultural scales emerged: (1) patient safety as everyone's priority; (2) teamwork; (3) valuing individuals; (4) open communication; (5) learning; and (6) empowering individuals. The reliability analysis found all six scales to have internal reliability (Cronbach alpha), ranging from 0.72 (open communication) to 0.84 (valuing individuals). The CAS developed for this study may enable obstetrical units to assess change in patient safety culture.

Evaluating the impact of patients' online access to doctors' visit notes: designing and executing the OpenNotes project

PubMed Central

2012-01-01

Many primary care physicians were willing to participate in this "real world" experiment testing the impact of OpenNotes on their patients and their practices. Results from this trial will inform providers, policy makers, and patients who contemplate such changes at a time of exploding interest in transparency, patient safety, and improving the quality of care. PMID:22500560

Epidemiological designs for vaccine safety assessment: methods and pitfalls.

PubMed

Andrews, Nick

2012-09-01

Three commonly used designs for vaccine safety assessment post licensure are cohort, case-control and self-controlled case series. These methods are often used with routine health databases and immunisation registries. This paper considers the issues that may arise when designing an epidemiological study, such as understanding the vaccine safety question, case definition and finding, limitations of data sources, uncontrolled confounding, and pitfalls that apply to the individual designs. The example of MMR and autism, where all three designs have been used, is presented to help consider these issues. Copyright © 2011 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

Assessment of the safety-relevance of pedestrian and bicyclist programs. Volume 1, Conduct and results

DOT National Transportation Integrated Search

1983-04-01

This document (Volume One of a Two Volume Report) describes the development of a paper-and-pencil instrument for assessing the safety relevance of pedestrian and bicyclist safety education programs. The safety relevance of the program is the extent t...

Electronic health records improve clinical note quality.

PubMed

Burke, Harry B; Sessums, Laura L; Hoang, Albert; Becher, Dorothy A; Fontelo, Paul; Liu, Fang; Stephens, Mark; Pangaro, Louis N; O'Malley, Patrick G; Baxi, Nancy S; Bunt, Christopher W; Capaldi, Vincent F; Chen, Julie M; Cooper, Barbara A; Djuric, David A; Hodge, Joshua A; Kane, Shawn; Magee, Charles; Makary, Zizette R; Mallory, Renee M; Miller, Thomas; Saperstein, Adam; Servey, Jessica; Gimbel, Ronald W

2015-01-01

The clinical note documents the clinician's information collection, problem assessment, clinical management, and its used for administrative purposes. Electronic health records (EHRs) are being implemented in clinical practices throughout the USA yet it is not known whether they improve the quality of clinical notes. The goal in this study was to determine if EHRs improve the quality of outpatient clinical notes. A five and a half year longitudinal retrospective multicenter quantitative study comparing the quality of handwritten and electronic outpatient clinical visit notes for 100 patients with type 2 diabetes at three time points: 6 months prior to the introduction of the EHR (before-EHR), 6 months after the introduction of the EHR (after-EHR), and 5 years after the introduction of the EHR (5-year-EHR). QNOTE, a validated quantitative instrument, was used to assess the quality of outpatient clinical notes. Its scores can range from a low of 0 to a high of 100. Sixteen primary care physicians with active practices used QNOTE to determine the quality of the 300 patient notes. The before-EHR, after-EHR, and 5-year-EHR grand mean scores (SD) were 52.0 (18.4), 61.2 (16.3), and 80.4 (8.9), respectively, and the change in scores for before-EHR to after-EHR and before-EHR to 5-year-EHR were 18% (p<0.0001) and 55% (p<0.0001), respectively. All the element and grand mean quality scores significantly improved over the 5-year time interval. The EHR significantly improved the overall quality of the outpatient clinical note and the quality of all its elements, including the core and non-core elements. To our knowledge, this is the first study to demonstrate that the EHR significantly improves the quality of clinical notes. © The Author 2014. Published by Oxford University Press on behalf of the American Medical Informatics Association.

Nuclear power and probabilistic safety assessment (PSA): past through future applications

NASA Astrophysics Data System (ADS)

Stamatelatos, M. G.; Moieni, P.; Everline, C. J.

1995-03-01

Nuclear power reactor safety in the United States is about to enter a new era -- an era of risk- based management and risk-based regulation. First, there was the age of `prescribed safety assessment,' during which a series of design-basis accidents in eight categories of severity, or classes, were postulated and analyzed. Toward the end of that era, it was recognized that `Class 9,' or `beyond design basis,' accidents would need special attention because of the potentially severe health and financial consequences of these accidents. The accident at Three Mile Island showed that sequences of low-consequence, high-frequency events and human errors can be much more risk dominant than the Class 9 accidents. A different form of safety assessment, PSA, emerged and began to gain ground against the deterministic safety establishment. Eventually, this led to the current regulatory requirements for individual plant examinations (IPEs). The IPEs can serve as a basis for risk-based regulation and management, a concept that may ultimately transform the U.S. regulatory process from its traditional deterministic foundations to a process predicated upon PSA. Beyond the possibility of a regulatory environment predicated upon PSA lies the possibility of using PSA as the foundation for managing daily nuclear power plant operations.

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.

Characteristics and safety assessment of intractable proteins in genetically modified crops.

PubMed

Bushey, Dean F; Bannon, Gary A; Delaney, Bryan F; Graser, Gerson; Hefford, Mary; Jiang, Xiaoxu; Lee, Thomas C; Madduri, Krishna M; Pariza, Michael; Privalle, Laura S; Ranjan, Rakesh; Saab-Rincon, Gloria; Schafer, Barry W; Thelen, Jay J; Zhang, John X Q; Harper, Marc S

2014-07-01

Genetically modified (GM) crops may contain newly expressed proteins that are described as "intractable". Safety assessment of these proteins may require some adaptations to the current assessment procedures. Intractable proteins are defined here as those proteins with properties that make it extremely difficult or impossible with current methods to express in heterologous systems; isolate, purify, or concentrate; quantify (due to low levels); demonstrate biological activity; or prove equivalency with plant proteins. Five classes of intractable proteins are discussed here: (1) membrane proteins, (2) signaling proteins, (3) transcription factors, (4) N-glycosylated proteins, and (5) resistance proteins (R-proteins, plant pathogen recognition proteins that activate innate immune responses). While the basic tiered weight-of-evidence approach for assessing the safety of GM crops proposed by the International Life Sciences Institute (ILSI) in 2008 is applicable to intractable proteins, new or modified methods may be required. For example, the first two steps in Tier I (hazard identification) analysis, gathering of applicable history of safe use (HOSU) information and bioinformatics analysis, do not require protein isolation. The extremely low level of expression of most intractable proteins should be taken into account while assessing safety of the intractable protein in GM crops. If Tier II (hazard characterization) analyses requiring animal feeding are judged to be necessary, alternatives to feeding high doses of pure protein may be needed. These alternatives are discussed here. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

Assessment of cognitive safety in clinical drug development

PubMed Central

Roiser, Jonathan P.; Nathan, Pradeep J.; Mander, Adrian P.; Adusei, Gabriel; Zavitz, Kenton H.; Blackwell, Andrew D.

2016-01-01

Cognitive impairment is increasingly recognised as an important potential adverse effect of medication. However, many drug development programmes do not incorporate sensitive cognitive measurements. Here, we review the rationale for cognitive safety assessment, and explain several basic methodological principles for measuring cognition during clinical drug development, including study design and statistical analysis, from Phase I through to postmarketing. The crucial issue of how cognition should be assessed is emphasized, especially the sensitivity of measurement. We also consider how best to interpret the magnitude of any identified effects, including comparison with benchmarks. We conclude by discussing strategies for the effective communication of cognitive risks. PMID:26610416

Safety assessment of personal care products/cosmetics and their ingredients.

PubMed

Nohynek, Gerhard J; Antignac, Eric; Re, Thomas; Toutain, Herve

2010-03-01

We attempt to review the safety assessment of personal care products (PCP) and ingredients that are representative and pose complex safety issues. PCP are generally applied to human skin and mainly produce local exposure, although skin penetration or use in the oral cavity, on the face, lips, eyes and mucosa may also produce human systemic exposure. In the EU, US and Japan, the safety of PCP is regulated under cosmetic and/or drug regulations. Oxidative hair dyes contain arylamines, the most chemically reactive ingredients of PCP. Although arylamines have an allergic potential, taking into account the high number of consumers exposed, the incidence and prevalence of hair dye allergy appears to be low and stable. A recent (2001) epidemiology study suggested an association of oxidative hair dye use and increased bladder cancer risk in consumers, although this was not confirmed by subsequent or previous epidemiologic investigations. The results of genetic toxicity, carcinogenicity and reproductive toxicity studies suggest that modern hair dyes and their ingredients pose no genotoxic, carcinogenic or reproductive risk. Recent reports suggest that arylamines contained in oxidative hair dyes are N-acetylated in human or mammalian skin resulting in systemic exposure to traces of detoxified, i.e. non-genotoxic, metabolites, whereas human hepatocytes were unable to transform hair dye arylamines to potentially carcinogenic metabolites. An expert panel of the International Agency on Research of Cancer (IARC) concluded that there is no evidence for a causal association of hair dye exposure with an elevated cancer risk in consumers. Ultraviolet filters have important benefits by protecting the consumer against adverse effects of UV radiation; these substances undergo a stringent safety evaluation under current international regulations prior to their marketing. Concerns were also raised about the safety of solid nanoparticles in PCP, mainly TiO(2) and ZnO in sunscreens. However

Safety assessment of personal care products/cosmetics and their ingredients

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

Nohynek, Gerhard J., E-mail: gnohynec@rd.loreal.co; Antignac, Eric; Re, Thomas

2010-03-01

We attempt to review the safety assessment of personal care products (PCP) and ingredients that are representative and pose complex safety issues. PCP are generally applied to human skin and mainly produce local exposure, although skin penetration or use in the oral cavity, on the face, lips, eyes and mucosa may also produce human systemic exposure. In the EU, US and Japan, the safety of PCP is regulated under cosmetic and/or drug regulations. Oxidative hair dyes contain arylamines, the most chemically reactive ingredients of PCP. Although arylamines have an allergic potential, taking into account the high number of consumers exposed,more » the incidence and prevalence of hair dye allergy appears to be low and stable. A recent (2001) epidemiology study suggested an association of oxidative hair dye use and increased bladder cancer risk in consumers, although this was not confirmed by subsequent or previous epidemiologic investigations. The results of genetic toxicity, carcinogenicity and reproductive toxicity studies suggest that modern hair dyes and their ingredients pose no genotoxic, carcinogenic or reproductive risk. Recent reports suggest that arylamines contained in oxidative hair dyes are N-acetylated in human or mammalian skin resulting in systemic exposure to traces of detoxified, i.e. non-genotoxic, metabolites, whereas human hepatocytes were unable to transform hair dye arylamines to potentially carcinogenic metabolites. An expert panel of the International Agency on Research of Cancer (IARC) concluded that there is no evidence for a causal association of hair dye exposure with an elevated cancer risk in consumers. Ultraviolet filters have important benefits by protecting the consumer against adverse effects of UV radiation; these substances undergo a stringent safety evaluation under current international regulations prior to their marketing. Concerns were also raised about the safety of solid nanoparticles in PCP, mainly TiO{sub 2} and ZnO in

Applicability of "MEGA"[Eighth Note] to Sexually Abusive Youth with Low Intellectual Functioning

ERIC Educational Resources Information Center

Miccio-Fonseca, L. C.; Rasmussen, Lucinda A.

2013-01-01

The study explored the predictive validity of "Multiplex Empirically Guided Inventory of Ecological Aggregates for Assessing Sexually Abusive Children and Adolescents (Ages 4 to 19)" ("MEGA"[eighth note]; Miccio-Fonseca, 2006b), a comprehensive developmentally sensitive risk assessment outcome tool. "MEGA"[eighth note] assesses risk for coarse…

Compressed natural gas bus safety: a quantitative risk assessment.

PubMed

Chamberlain, Samuel; Modarres, Mohammad

2005-04-01

This study assesses the fire safety risks associated with compressed natural gas (CNG) vehicle systems, comprising primarily a typical school bus and supporting fuel infrastructure. The study determines the sensitivity of the results to variations in component failure rates and consequences of fire events. The components and subsystems that contribute most to fire safety risk are determined. Finally, the results are compared to fire risks of the present generation of diesel-fueled school buses. Direct computation of the safety risks associated with diesel-powered vehicles is possible because these are mature technologies for which historical performance data are available. Because of limited experience, fatal accident data for CNG bus fleets are minimal. Therefore, this study uses the probabilistic risk assessment (PRA) approach to model and predict fire safety risk of CNG buses. Generic failure data, engineering judgments, and assumptions are used in this study. This study predicts the mean fire fatality risk for typical CNG buses as approximately 0.23 fatalities per 100-million miles for all people involved, including bus passengers. The study estimates mean values of 0.16 fatalities per 100-million miles for bus passengers only. Based on historical data, diesel school bus mean fire fatality risk is 0.091 and 0.0007 per 100-million miles for all people and bus passengers, respectively. One can therefore conclude that CNG buses are more prone to fire fatality risk by 2.5 times that of diesel buses, with the bus passengers being more at risk by over two orders of magnitude. The study estimates a mean fire risk frequency of 2.2 x 10(-5) fatalities/bus per year. The 5% and 95% uncertainty bounds are 9.1 x 10(-6) and 4.0 x 10(-5), respectively. The risk result was found to be affected most by failure rates of pressure relief valves, CNG cylinders, and fuel piping.

Clinical Note Creation, Binning, and Artificial Intelligence

PubMed Central

Deliberato, Rodrigo Octávio; Stone, David J

2017-01-01

The creation of medical notes in software applications poses an intrinsic problem in workflow as the technology inherently intervenes in the processes of collecting and assembling information, as well as the production of a data-driven note that meets both individual and healthcare system requirements. In addition, the note writing applications in currently available electronic health records (EHRs) do not function to support decision making to any substantial degree. We suggest that artificial intelligence (AI) could be utilized to facilitate the workflows of the data collection and assembly processes, as well as to support the development of personalized, yet data-driven assessments and plans. PMID:28778845

The transvaginal hybrid NOTES versus conventionally assisted laparoscopic sigmoid resection for diverticular disease (TRANSVERSAL) trial: study protocol for a randomized controlled trial.

PubMed

Senft, Jonas D; Warschkow, Rene; Diener, Markus K; Tarantino, Ignazio; Steinemann, Daniel C; Lamm, Sebastian; Simon, Thomas; Zerz, Andreas; Müller-Stich, Beat P; Linke, Georg R

2014-11-20

Natural orifice transluminal endoscopic surgery (NOTES) is the consequence of further development of minimally invasive surgery to reduce abdominal incisions and surgical trauma. The potential benefits are expected to be less postoperative pain, faster convalescence, and reduced risk for incisional hernias and wound infections compared to conventional methods. Recent clinical studies have demonstrated the feasibility and safety of transvaginal NOTES, and transvaginal access is currently the most frequent clinically applied route for NOTES procedures. However, despite increasing clinical application, no firm clinical evidence is available for objective assessment of the potential benefits and risks of transvaginal NOTES compared to the current surgical standard. The TRANSVERSAL trial is designed as a randomized controlled trial to compare transvaginal hybrid NOTES and laparoscopic-assisted sigmoid resection. Female patients referred to elective sigmoid resection due to complicated or reoccurring diverticulitis of the sigmoid colon are considered eligible. The primary endpoint will be pain intensity during mobilization 24 hours postoperatively as measured by the blinded patient and blinded assessor on a visual analogue scale (VAS). Secondary outcomes include daily pain intensity and analgesic use, patient mobility, intraoperative complications, morbidity, length of stay, quality of life, and sexual function. Follow-up visits are scheduled 3, 12, and 36 months after surgery. A total sample size of 58 patients was determined for the analysis of the primary endpoint. The confirmatory analysis will be performed based on the intention-to-treat (ITT) principle. The TRANSVERSAL trial is the first study to compare transvaginal hybrid NOTES and conventionally assisted laparoscopic surgery for colonic resection in a randomized controlled setting. The results of the TRANSVERSAL trial will allow objective assessment of the potential benefits and risks of NOTES compared to the

Assessment of Native Languages for Food Safety Training Programs for Meat Industry Employees

ERIC Educational Resources Information Center

Olsen, Sherrlyn S.; Cordray, Joseph C.; Sapp, Stephen; Sebranek, Joseph G.; Anderson, Barbara; Wenger, Matt

2012-01-01

Challenges arise when teaching food safety to culturally diverse employees working in meatpacking and food manufacturing industries. A food safety training program was developed in English, translated into Spanish, and administered to 1,265 adult learners. Assessments were conducted by comparing scores before and immediately following training.…

Healthcare Databases for Drug Safety Research: Data Validity Assessment Remains Crucial.

PubMed

Rawson, Nigel S B; D'Arcy, Carl

2018-04-30

Administrative healthcare utilization databases are frequently used either individually or as a component of aggregated data for evaluating drug safety issues without taking into account their known deficiencies. All too often insufficient evidence is provided about their validity for the purposes for which they are used. The assessment of data validity is a key constituent that should be included in drug safety research studies and should take a broad multifaceted approach that encompasses both diagnostic and drug exposure data. Drug safety researchers need to continue advancing their knowledge of the data resources they use and to ensure that they and the users of their research understand the limitations of the data that are the foundation on which their research is built. Fundamental issues regarding data validity should be addressed in each use of administrative data for drug safety research.

Seismic performance assessment of base-isolated safety-related nuclear structures

USGS Publications Warehouse

Huang, Y.-N.; Whittaker, A.S.; Luco, N.

2010-01-01

Seismic or base isolation is a proven technology for reducing the effects of earthquake shaking on buildings, bridges and infrastructure. The benefit of base isolation has been presented in terms of reduced accelerations and drifts on superstructure components but never quantified in terms of either a percentage reduction in seismic loss (or percentage increase in safety) or the probability of an unacceptable performance. Herein, we quantify the benefits of base isolation in terms of increased safety (or smaller loss) by comparing the safety of a sample conventional and base-isolated nuclear power plant (NPP) located in the Eastern U.S. Scenario- and time-based assessments are performed using a new methodology. Three base isolation systems are considered, namely, (1) Friction Pendulum??? bearings, (2) lead-rubber bearings and (3) low-damping rubber bearings together with linear viscous dampers. Unacceptable performance is defined by the failure of key secondary systems because these systems represent much of the investment in a new build power plant and ensure the safe operation of the plant. For the scenario-based assessments, the probability of unacceptable performance is computed for an earthquake with a magnitude of 5.3 at a distance 7.5 km from the plant. For the time-based assessments, the annual frequency of unacceptable performance is computed considering all potential earthquakes that may occur. For both assessments, the implementation of base isolation reduces the probability of unacceptable performance by approximately four orders of magnitude for the same NPP superstructure and secondary systems. The increase in NPP construction cost associated with the installation of seismic isolators can be offset by substantially reducing the required seismic strength of secondary components and systems and potentially eliminating the need to seismically qualify many secondary components and systems. ?? 2010 John Wiley & Sons, Ltd.

75 FR 17604 - Federal Motor Vehicle Safety Standards; Roof Crush Resistance

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-07

... Safety Analysis & Forensic Engineering, LLC (SAFE) brought to our attention errors in the preamble that incorrectly attributed to it the comments of another organization, Safety Analysis, Inc. Both of these... Safety Analysis, Inc. SAFE noted that there is no affiliation between SAFE and Safety Analysis, Inc. and...

Brakes: Traffic Safety Tips

DOT National Transportation Integrated Search

1996-01-01

This fact sheet, NHTSA Facts: Summer 1996, describes traffic safety tips about brakes. It discusses drum brakes, disc brakes, and antilock braking systsms. It notes that there are government standards for brakes, and describes how to take care of bra...

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

75 FR 15485 - Pipeline Safety: Workshop on Guidelines for Integrity Assessment of Cased Pipe

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-29

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket ID...: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Notice of workshop. SUMMARY... ``Guidelines for Integrity Assessment of Cased Pipe in Gas Transmission Pipelines'' and related Frequently...

PROBABILISTIC SAFETY ASSESSMENT OF OPERATIONAL ACCIDENTS AT THE WASTE ISOLATION PILOT PLANT

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

Rucker, D.F.

2000-09-01

This report presents a probabilistic safety assessment of radioactive doses as consequences from accident scenarios to complement the deterministic assessment presented in the Waste Isolation Pilot Plant (WIPP) Safety Analysis Report (SAR). The International Council of Radiation Protection (ICRP) recommends both assessments be conducted to ensure that ''an adequate level of safety has been achieved and that no major contributors to risk are overlooked'' (ICRP 1993). To that end, the probabilistic assessment for the WIPP accident scenarios addresses the wide range of assumptions, e.g. the range of values representing the radioactive source of an accident, that could possibly have beenmore » overlooked by the SAR. Routine releases of radionuclides from the WIPP repository to the environment during the waste emplacement operations are expected to be essentially zero. In contrast, potential accidental releases from postulated accident scenarios during waste handling and emplacement could be substantial, which necessitates the need for radiological air monitoring and confinement barriers (DOE 1999). The WIPP Safety Analysis Report (SAR) calculated doses from accidental releases to the on-site (at 100 m from the source) and off-site (at the Exclusive Use Boundary and Site Boundary) public by a deterministic approach. This approach, as demonstrated in the SAR, uses single-point values of key parameters to assess the 50-year, whole-body committed effective dose equivalent (CEDE). The basic assumptions used in the SAR to formulate the CEDE are retained for this report's probabilistic assessment. However, for the probabilistic assessment, single-point parameter values were replaced with probability density functions (PDF) and were sampled over an expected range. Monte Carlo simulations were run, in which 10,000 iterations were performed by randomly selecting one value for each parameter and calculating the dose. Statistical information was then derived from the 10

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

Assessing community child passenger safety efforts in three Northwest Tribes.

PubMed

Smith, M L; Berger, L R

2002-12-01

To identify strengths and weaknesses in community based child passenger safety programs by developing a scoring instrument and conducting observations of child restraint use in three Native American communities. The three communities are autonomous Tribal reservations in the Pacific Northwest. Their per capita incomes and rates of unemployment are comparable. In each community, 100 children under 5 years old were observed for car seat use. A six item community assessment tool (100 points maximum) awarded points for such items as the type (primary or secondary) and enforcement of child restraint laws; availability of car seats from distribution programs; extent of educational programs; and access to data on vehicle injuries. For children from birth to 4 years, the car seat use rate ranged from 12%-21%. Rates for infants (71%-80%) far exceeded rates for 1-4 year old children (5%-14%). Community scores ranged from 0 to 31.5 points. There was no correlation between scores and observed car seat use. One reason was the total lack of enforcement of restraint laws. A community assessment tool can highlight weaknesses in child passenger efforts. Linking such a tool with an objective measure of impact can be applied to other injury problems, such as fire safety or domestic violence. The very process of creating and implementing a community assessment can enhance agency collaboration and publicize evidence based "best practices" for injury prevention. Further study is needed to address methodologic issues and to examine crash and medical data in relation to community child passenger safety scores.

Safety Assessment of Probiotics

NASA Astrophysics Data System (ADS)

Lahtinen, Sampo J.; Boyle, Robert J.; Margolles, Abelardo; Frias, Rafael; Gueimonde, Miguel

Viable microbes have been a natural part of human diet throughout the history of mankind. Today, different fermented foods and other foods containing live microbes are consumed around the world, including industrialized countries, where the diet has become increasingly sterile during the last decades. By definition, probiotics are viable microbes with documented beneficial effects on host health. Probiotics have an excellent safety record, both in humans and in animals. Despite the wide and continuously increasing consumption of probiotics, adverse events related to probiotic use are extremely rare. Many popular probiotic strains such as lactobacilli and bifidobacteria can be considered as components of normal healthy intestinal microbiota, and thus are not thought to pose a risk for the host health - in contrast, beneficial effects on health are commonly reported. Nevertheless, the safety of probiotics is an important issue, in particular in the case of new potential probiotics which do not have a long history of safe use, and of probiotics belonging to species for which general assumption of safety cannot be made. Furthermore, safety of probiotics in high-risk populations such as critically ill patients and immunocompromized subjects deserves particular attention, as virtually all reported cases of bacteremia and fungemia associated with probiotic use, involve subjects with underlying diseases, compromised immune system or compromised intestinal integrity.

Validity of instruments to assess students' travel and pedestrian safety

USDA-ARS?s Scientific Manuscript database

Safe Routes to School (SRTS) programs are designed to make walking and bicycling to school,safe and accessible for children. Despite their growing popularity, few validated measures exist for assessing important outcomes such as type of student transport or pedestrian safety behaviors. This research...

Ports and Waterways Safety Assessment Workshop Report. Kahului Harbor, Maui, Hawaii, 27-28 August 2009

DTIC Science & Technology

2009-08-28

and Waterways Safety Assessment Workshop Report Maui, Hawaii 27 - 28 August 2009 Kahului Harbor Report Documentation Page Form ApprovedOMB...00-00-2009 to 00-00-2009 4. TITLE AND SUBTITLE Ports and Waterways Safety Assessment: Maui, Hawaii 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c...Harbor, Maui, Hawaii 27 - 28 August 2009 Table of Contents Page Introduction

Assessment of radiation safety awareness among nuclear medicine nurses: a pilot study

NASA Astrophysics Data System (ADS)

Yunus, N. A.; Abdullah, M. H. R. O.; Said, M. A.; Ch'ng, P. E.

2014-11-01

All nuclear medicine nurses need to have some knowledge and awareness on radiation safety. At present, there is no study to address this issue in Malaysia. The aims of this study were (1) to determine the level of knowledge and awareness on radiation safety among nuclear medicine nurses at Putrajaya Hospital in Malaysia and (2) to assess the effectiveness of a training program provided by the hospital to increase the knowledge and awareness of the nuclear medicine nurses. A total of 27 respondents attending a training program on radiation safety were asked to complete a questionnaire. The questionnaire consists 16 items and were categorized into two main areas, namely general radiation knowledge and radiation safety. Survey data were collected before and after the training and were analyzed using descriptive statistics and paired sample t-test. Respondents were scored out of a total of 16 marks with 8 marks for each area. The findings showed that the range of total scores obtained by the nuclear medicine nurses before and after the training were 6-14 (with a mean score of 11.19) and 13-16 marks (with a mean score of 14.85), respectively. Findings also revealed that the mean score for the area of general radiation knowledge (7.59) was higher than that of the radiation safety (7.26). Currently, the knowledge and awareness on radiation safety among the nuclear medicine nurses are at the moderate level. It is recommended that a national study be conducted to assess and increase the level of knowledge and awareness among all nuclear medicine nurses in Malaysia.

Use and misuse of motor-vehicle crash death rates in assessing highway-safety performance.

PubMed

O'Neill, Brian; Kyrychenko, Sergey Y

2006-12-01

The objectives of the article are to assess the extent to which comparisons of motor-vehicle crash death rates can be used to determine the effectiveness of highway-safety policies over time in a country or to compare policy effectiveness across countries. Motor-vehicle crash death rates per mile traveled in the 50 U.S. states from 1980 to 2003 are used to show the influence on these rates of factors independent of highway-safety interventions. Multiple regression models relating state death rates to various measures related to urbanization and demographics are used. The analyses demonstrate strong relationships between state death rates and urbanization and demographics. Almost 60% of the variability among the state death rates can be explained by the independent variables in the multiple regression models. When the death rates for passenger vehicle occupants (i.e., excluding motorcycle, pedestrian, and other deaths) are used in the regression models, almost 70% of the variability in the rates can be explained by urbanization and demographics. The analyses presented in the article demonstrate that motor-vehicle crash death rates are strongly influenced by factors unrelated to highway-safety countermeasures. Overall death rates should not be used as a basis for judging the effectiveness (or ineffectiveness) of specific highway-safety countermeasures or to assess overall highway-safety policies, especially across jurisdictions. There can be no substitute for the use of carefully designed scientific evaluations of highway-safety interventions that use outcome measures directly related to the intervention; e.g., motorcyclist deaths should be used to assess the effectiveness of motorcycle helmet laws. While this may seem obvious, there are numerous examples in the literature of death rates from all crashes being used to assess the effectiveness of interventions aimed at specific subsets of crashes.

Schools and Disasters: Safety and Mental Health Assessment and Interventions for Children.

PubMed

Lai, Betty S; Esnard, Ann-Margaret; Lowe, Sarah R; Peek, Lori

2016-12-01

This article draws on experiences and lessons from global disasters and utilizes the United Nations Comprehensive School Safety Framework to highlight the necessary role of safe schools in protecting children, as well as adult staff, from the immediate threats and long-term implications of disasters. Specifically, we focus on three well-established pillars of school safety: Pillar I: Safe Learning Facilities; Pillar II: Disaster Management; and Pillar III: Risk Reduction and Resilience Education. In addition, we propose a potential fourth pillar, which underscores the function of schools in postdisaster mental health assessment and intervention for children. We argue that schools offer a central location and trusted institutional space for mental health assessment and intervention after disasters. We also examine the important linkages between schools, child mental health, and household and family recovery. We conclude with recommendations for filling gaps in research and practice related to ensuring the safety of schools and the associated health and well-being of children in the face of future disasters.

Pushing and pulling: an assessment tool for occupational health and safety practitioners.

PubMed

Lind, Carl Mikael

2018-03-01

A tool has been developed for supporting practitioners when assessing manual pushing and pulling operations based on an initiative by two global companies in the manufacturing industry. The aim of the tool is to support occupational health and safety practitioners in risk assessment and risk management of pushing and pulling operations in the manufacturing and logistics industries. The tool is based on a nine-multiplier equation that includes a wide range of factors affecting an operator's health risk and capacity in pushing and pulling. These multipliers are based on psychophysical, physiological and biomechanical studies in combination with judgments from an expert group consisting of senior researchers and ergonomists. In order to consider usability, more than 50 occupational health and safety practitioners (e.g., ergonomists, managers, safety representatives and production personnel) participated in the development of the tool. An evaluation by 22 ergonomists supports that the push/pull tool is user friendly in general.

Patient safety and patient assessment in pre-hospital care: a study protocol.

PubMed

Hagiwara, Magnus Andersson; Nilsson, Lena; Strömsöe, Anneli; Axelsson, Christer; Kängström, Anna; Herlitz, Johan

2016-02-12

Patient safety issues in pre-hospital care are poorly investigated. The aim of the planned study is to survey patient safety problems in pre-hospital care in Sweden. The study is a retro-perspective structured medical record review based on the use of 11 screening criteria. Two instruments for structured medical record review are used: a trigger tool instrument designed for pre-hospital care and a newly development instrument designed to compare the pre-hospital assessment with the final hospital assessment. Three different ambulance organisations are participating in the study. Every month, one rater in each organisation randomly collects 30 medical records for review. With guidance from the review instrument, he/she independently reviews the record. Every month, the review team meet for a discussion of problematic reviews. The results will be analysed with descriptive statistics and logistic regression. The findings will make an important contribution to knowledge about patient safety issues in pre-hospital care.

Safety Assessment of Methyl Glucose Polyethers and Esters as Used in Cosmetics.

PubMed

Johnson, Wilbur; 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 Expert Panel (Panel) reviewed the safety of methyl glucose polyethers and esters which function in cosmetics as skin/hair-conditioning agents, surfactants, or viscosity increasing agents. The esters included in this assessment are mono-, di-, or tricarboxyester substituted methyl glucosides, and the polyethers are mixtures of various chain lengths. The Panel reviewed available animal and clinical data, including the molecular weights, log K ow s, and other properties in making its determination of safety on these ingredients. Where there were data gaps, similarities between molecular structures, physicochemical and biological characteristics, and functions and concentrations in cosmetics allowed for extrapolation of the available toxicological data to assess the safety of the entire group. The Panel concluded that there likely would be no significant systemic exposure from cosmetic use of these ingredients, and that these ingredients are safe in cosmetic formulations in the present practices of use and concentration. © The Author(s) 2016.

Non-animal approaches for consumer safety risk assessments: Unilever's scientific research programme.

PubMed

Carmichael, Paul; Davies, Michael; Dent, Matt; Fentem, Julia; Fletcher, Samantha; Gilmour, Nicola; MacKay, Cameron; Maxwell, Gavin; Merolla, Leona; Pease, Camilla; Reynolds, Fiona; Westmoreland, Carl

2009-12-01

Non-animal based approaches to risk assessment are now routinely used for assuring consumer safety for some endpoints (such as skin irritation) following considerable investment in developing and applying new methods over the past 20 years. Unilever's research programme into non-animal approaches for safety assessment is currently focused on the application of new technologies to risk assessments in the areas of skin allergy, cancer and general toxicity (including inhalation toxicity). In all of these areas, a long-term investment is essential to increase the scientific understanding of the underlying biological and chemical processes that we believe will ultimately form a sound basis for novel risk assessment approaches. Our research programme in these priority areas consists of in-house research as well as Unilever-sponsored academic research, involvement with EU-funded projects (e.g. Sens-it-iv, carcinoGENOMICS), participation in cross-industry collaborative research (e.g. COLIPA, EPAA) and ongoing involvement with other scientific initiatives on non-animal approaches to risk assessment (e.g. UK NC3Rs, US 'Human Toxicology Project' consortium). 2009 FRAME.

Neuropsychological Assessment of Driving Safety Risk in Older Adults With and Without Neurologic Disease

PubMed Central

Anderson, Steven W.; Aksan, Nazan; Dawson, Jeffrey D.; Uc, Ergun Y.; Johnson, Amy M.; Rizzo, Matthew

2013-01-01

Decline in cognitive abilities can be an important contributor to the driving problems encountered by older adults, and neuropsychological assessment may provide a practical approach to evaluating this aspect of driving safety risk. The purpose of the present study was to evaluate several commonly used neuropsychological tests in the assessment of driving safety risk in older adults with and without neurological disease. A further goal of this study was to identify brief combinations of neuropsychological tests that sample performances in key functional domains and thus could be used to efficiently assess driving safety risk. 345 legally licensed and active drivers over the age of 50, with either no neurologic disease (N=185), probable Alzheimer's disease (N=40), Parkinson's disease (N=91), or stroke (N=29), completed vision testing, a battery of 10 neuropsychological tests, and an 18 mile drive on urban and rural roads in an instrumented vehicle. Performances on all neuropsychological tests were significantly correlated with driving safety errors. Confirmatory factor analysis was used to identify 3 key cognitive domains assessed by the tests (speed of processing, visuospatial abilities, and memory), and several brief batteries consisting of one test from each domain showed moderate corrected correlations with driving performance. These findings are consistent with the notion that driving places demands on multiple cognitive abilities that can be affected by aging and age-related neurological disease, and that neuropsychological assessment may provide a practical off-road window into the functional status of these cognitive systems. PMID:22943767

Neuropsychological assessment of driving safety risk in older adults with and without neurologic disease.

PubMed

Anderson, Steven W; Aksan, Nazan; Dawson, Jeffrey D; Uc, Ergun Y; Johnson, Amy M; Rizzo, Matthew

2012-01-01

Decline in cognitive abilities can be an important contributor to the driving problems encountered by older adults, and neuropsychological assessment may provide a practical approach to evaluating this aspect of driving safety risk. The purpose of the present study was to evaluate several commonly used neuropsychological tests in the assessment of driving safety risk in older adults with and without neurological disease. A further goal of this study was to identify brief combinations of neuropsychological tests that sample performances in key functional domains and thus could be used to efficiently assess driving safety risk. A total of 345 legally licensed and active drivers over the age of 50, with no neurologic disease (N = 185), probable Alzheimer's disease (N = 40), Parkinson's disease (N = 91), or stroke (N = 29), completed vision testing, a battery of 10 neuropsychological tests, and an 18-mile drive on urban and rural roads in an instrumented vehicle. Performances on all neuropsychological tests were significantly correlated with driving safety errors. Confirmatory factor analysis was used to identify 3 key cognitive domains assessed by the tests (speed of processing, visuospatial abilities, and memory), and several brief batteries consisting of one test from each domain showed moderate corrected correlations with driving performance. These findings are consistent with the notion that driving places demands on multiple cognitive abilities that can be affected by aging and age-related neurological disease, and that neuropsychological assessment may provide a practical off-road window into the functional status of these cognitive systems.

Assessment of the Impact of Scheduled Postmarketing Safety Summary Analyses on Regulatory Actions

PubMed Central

Sekine, S; Pinnow, EE; Wu, E; Kurtzig, R; Hall, M; Dal Pan, GJ

2016-01-01

In addition to standard postmarketing drug safety monitoring, Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) requires the US Food and Drug Administration (FDA) to conduct a summary analysis of adverse event reports to identify risks of a drug or biologic product 18 months after product approval, or after 10,000 patients have used the product, whichever is later. We assessed the extent to which these analyses identified new safety signals and resultant safety-related label changes. Among 458 newly approved products, 300 were the subjects of a scheduled analysis; a new safety signal that resulted in a safety-related label change was found for 11 of these products. Less than 2% of 713 safety-related label changes were based on the scheduled analyses. Our study suggests that the safety summary analyses provide only marginal value over other pharmacovigilance activities. PMID:26853718

Major food safety episodes in Taiwan: implications for the necessity of international collaboration on safety assessment and management.

PubMed

Li, Jih-Heng; Yu, Wen-Jing; Lai, Yuan-Hui; Ko, Ying-Chin

2012-07-01

The major food safety episodes that occurred in Taiwan during the past decade are briefly reviewed in this paper. Among the nine major episodes surveyed, with the exception of a U.S. beef (associated with Creutzfeldt-Jakob disease)-related incident, all the others were associated with chemical toxicants. The general public, which has a layperson attitude of zero tolerance toward food safety, may panic over these food-safety-associated incidents. However, the health effects and impacts of most incidents, with the exception of the melamine incident, were essentially not fully evaluated. The mass media play an important role in determining whether a food safety concern becomes a major incident. A well-coordinated and harmonized system for domestic and international collaboration to set up standards and regulations is critical, as observed in the incidents of pork with ractopamine, Chinese hairy crab with nitrofuran antibiotics, and U.S. wheat with malathion. In the future, it can be anticipated that food safety issues will draw more attention from the general public. For unknown new toxicants or illicit adulteration of food, the establishment of a more proactive safety assessment system to monitor potential threats and provide real-time information exchange is imperative. Copyright © 2012. Published by Elsevier B.V.

Bumpers: Traffic Safety Tips

DOT National Transportation Integrated Search

1996-01-01

This fact sheet, NHTSA Facts: Summer 1996, discusses automobile bumpers. It notes that a car bumper is not a safety device to prevent or reduce injuries to people in the car. Instead, it is designed to protect the hood, trunk, grille, parking lights,...

Quantitative assessment of building fire risk to life safety.

PubMed

Guanquan, Chu; Jinhua, Sun

2008-06-01

This article presents a quantitative risk assessment framework for evaluating fire risk to life safety. Fire risk is divided into two parts: probability and corresponding consequence of every fire scenario. The time-dependent event tree technique is used to analyze probable fire scenarios based on the effect of fire protection systems on fire spread and smoke movement. To obtain the variation of occurrence probability with time, Markov chain is combined with a time-dependent event tree for stochastic analysis on the occurrence probability of fire scenarios. To obtain consequences of every fire scenario, some uncertainties are considered in the risk analysis process. When calculating the onset time to untenable conditions, a range of fires are designed based on different fire growth rates, after which uncertainty of onset time to untenable conditions can be characterized by probability distribution. When calculating occupant evacuation time, occupant premovement time is considered as a probability distribution. Consequences of a fire scenario can be evaluated according to probability distribution of evacuation time and onset time of untenable conditions. Then, fire risk to life safety can be evaluated based on occurrence probability and consequences of every fire scenario. To express the risk assessment method in detail, a commercial building is presented as a case study. A discussion compares the assessment result of the case study with fire statistics.

Nanotechnology in food science: Functionality, applicability, and safety assessment.

PubMed

He, Xiaojia; Hwang, Huey-Min

2016-10-01

Rapid development of nanotechnology is expected to transform many areas of food science and food industry with increasing investment and market share. In this article, current applications of nanotechnology in food systems are briefly reviewed. Functionality and applicability of food-related nanotechnology are highlighted in order to provide a comprehensive view on the development and safety assessment of nanotechnology in the food industry. While food nanotechnology offers great potential benefits, there are emerging concerns arising from its novel physicochemical properties. Therefore, the safety concerns and regulatory policies on its manufacturing, processing, packaging, and consumption are briefly addressed. At the end of this article, the perspectives of nanotechnology in active and intelligent packaging applications are highlighted. Copyright © 2016. Published by Elsevier B.V.

Implementation of Alternative Test Strategies for the Safety Assessment of Engineered Nanomaterials

PubMed Central

Nel, Andre

2014-01-01

Nanotechnology introduces a new field that requires novel approaches and methods for hazard and risk assessment. For an appropriate scientific platform for safety assessment, nanoscale properties and functions of engineered nanomaterials (ENMs), including how the physicochemical properties of the materials related to mechanisms of injury at the nano-bio interface, must be considered. Moreover, this rapidly advancing new field requires novel test strategies that allow multiple toxicants to be screened in robust, mechanism-based assays in which the bulk of the investigation can be carried out at the cellular and biomolecular level whilst maintaining limited animal use and is based on the contribution of toxicological pathways to the pathophysiology of disease. First, a predictive toxicological approach for the safety assessment of ENMs will be discussed against the background of a ‘21st-century vision’ for using alternative test strategies (ATSs) to perform toxicological assessment of large numbers of untested chemicals, thereby reducing a backlog that could otherwise become a problem for nanotechnology. An ATS is defined here as an alternative/reduction alternative to traditional animal testing. Secondly, the approach of selecting pathways of toxicity to screen for the pulmonary hazard potential of carbon nanotubes and metal oxides will be discussed, as well as how to use these pathways to perform high-content or high-throughput testing and how the data can be used for hazard ranking, risk assessment, regulatory decision-making and ‘safer-by-design’ strategies. Finally, the utility and disadvantages of this predictive toxicological approach to ENM safety assessment, and how it can assist the 21st- century vision, will be addressed PMID:23879741

Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials: The OMERACT Safety Working Group.

PubMed

Klokker, Louise; Tugwell, Peter; Furst, Daniel E; Devoe, Dan; Williamson, Paula; Terwee, Caroline B; Suarez-Almazor, Maria E; Strand, Vibeke; Woodworth, Thasia; Leong, Amye L; Goel, Niti; Boers, Maarten; Brooks, Peter M; Simon, Lee S; Christensen, Robin

2017-12-01

Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions. The safety issue has previously been discussed at OMERACT, but without a consistent approach to ensure harms were included in COS. Our methods include (1) identifying harmful outcomes in trials of interventions studied in patients with rheumatic diseases by a systematic literature review, (2) identifying components of safety that should be measured in such trials by use of a patient-driven approach including qualitative data collection and statistical organization of data, and (3) developing a COS through consensus processes including everyone involved. Members of OMERACT including patients, clinicians, researchers, methodologists, and industry representatives reached consensus on the need to continue the efforts on developing a COS for safety in rheumatology trials. There was a general agreement about the need to identify safety-related outcomes that are meaningful to patients, framed in terms that patients consider relevant so that they will be able to make informed decisions. The OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach.

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

NASA Astrophysics Data System (ADS)

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

2005-12-01

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

Insurance Discounts: Traffic Safety Tips

DOT National Transportation Integrated Search

1996-01-01

This fact sheet, NHTSA Facts: Summer 1996, discusses automobile insurance discounts. It relates how to obtain a discount, and details what factors can influence insurance premiums. It notes that discounts for safety features vary from insurance compa...

Integrated risk assessment and screening analysis of drinking water safety of a conventional water supply system.

PubMed

Sun, F; Chen, J; Tong, Q; Zeng, S

2007-01-01

Management of drinking water safety is changing towards an integrated risk assessment and risk management approach that includes all processes in a water supply system from catchment to consumers. However, given the large number of water supply systems in China and the cost of implementing such a risk assessment procedure, there is a necessity to first conduct a strategic screening analysis at a national level. An integrated methodology of risk assessment and screening analysis is thus proposed to evaluate drinking water safety of a conventional water supply system. The violation probability, indicating drinking water safety, is estimated at different locations of a water supply system in terms of permanganate index, ammonia nitrogen, turbidity, residual chlorine and trihalomethanes. Critical parameters with respect to drinking water safety are then identified, based on which an index system is developed to prioritize conventional water supply systems in implementing a detailed risk assessment procedure. The evaluation results are represented as graphic check matrices for the concerned hazards in drinking water, from which the vulnerability of a conventional water supply system is characterized.

Promoting the safety performance of industrial radiography using a quantitative assessment system.

PubMed

Kardan, M R; Mianji, F A; Rastkhah, N; Babakhani, A; Azad, S Borhan

2006-12-01

The increasing number of industrial radiographers and their considerable occupational exposure has been one of the main concerns of the Iran Nuclear Regulatory Authority (INRA) in recent years. In 2002, a quantitative system of evaluating the safety performance of licensees and a complementary enforcement system was introduced by the National Radiation Protection Department (NRPD). Each parameter of the practice is given a weighting factor according to its importance to safety. Assessment of the licensees is done quantitatively by summing up their scores using prepared tables. Implementing this system of evaluation showed a considerable decrease in deficiencies in the various centres. Tables are updated regularly as a result of findings during the inspections. This system is used in addition to enforcement to promote safety performance and to increase the culture of safety in industrial radiography.

Registered nurses' decision-making regarding documentation in patients' progress notes.

PubMed

Tower, Marion; Chaboyer, Wendy; Green, Quentine; Dyer, Kirsten; Wallis, Marianne

2012-10-01

To examine registered nurses' decision-making when documenting care in patients' progress notes. What constitutes effective nursing documentation is supported by available guidelines. However, ineffective documentation continues to be cited as a major cause of adverse events for patients. Decision-making in clinical practice is a complex process. To make an effective decision, the decision-maker must be situationally aware. The concept of situation awareness and its implications for making safe decisions has been examined extensively in air safety and more recently is being applied to health. The study was situated in a naturalistic paradigm. Purposive sampling was used to recruit 17 registered nurses who used think-aloud research methods when making decisions about documenting information in patients' progress notes. Follow-up interviews were conducted to validate interpretations. Data were analysed systematically for evidence of cues that demonstrated situation awareness as nurses made decisions about documentation. Three distinct decision-making scenarios were illuminated from the analysis: the newly admitted patient, the patient whose condition was as expected and the discharging patient. Nurses used mental models for decision-making in documenting in progress notes, and the cues nurses used to direct their assessment of patients' needs demonstrated situation awareness at different levels. Nurses demonstrate situation awareness at different levels in their decision-making processes. While situation awareness is important, it is also important to use an appropriate decision-making framework. Cognitive continuum theory is suggested as a decision-making model that could support situation awareness when nurses made decisions about documenting patient care. Because nurses are key decision-makers, it is imperative that effective decisions are made that translate into safe clinical care. Including situation awareness training, combined with employing cognitive

Suicide notes.

PubMed

O'Donnell, I; Farmer, R; Catalan, J

1993-07-01

Detailed case reports of incidents of suicide and attempted suicide on the London Underground railway system between 1985 and 1989 were examined for the presence of suicide notes. The incidence of note-leaving was 15%. Notes provided little insight into the causes of suicide as subjectively perceived, or strategies for suicide prevention.

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.

Research Notes - An Introduction to Openness and Evolvability Assessment

DTIC Science & Technology

2016-08-01

importance of different business and technical characteristics that combine to achieve an open solution. The complexity of most large-scale systems of...process characteristic)  Granularity of the architecture (size of functional blocks)  Modularity (cohesion and coupling)  Support for multiple...Description)  OV-3 (Operational Information Exchange Matrix)  SV-1 (Systems Interface Description)  TV-1 ( Technical Standards Profile). Note that there

Safety assessment of Cracked K-joint Structure Based on Fracture Mechanics

NASA Astrophysics Data System (ADS)

Wang, Xin; Pengyu, Yan; Jianwei, Du; Fuhai, Cai

2017-05-01

The K-joint is the main bearing structure of lattice jib crane. During frequent operation of the crane, surface cracks often occur at its weld toe, and then continue to expand until failure. The safety of the weak structure K-joint of the crane jib can be evaluated by BS7910 failure assessment standard in order to improve its utilization. The finite element model of K-joint structure with cracks is established, and its mechanical properties is analyzed by ABAQUS software, the results show that the crack depth has a great influence on the bearing capacity of the structure compared with the crack length. It is assumed that the K-joint with the semi-elliptical surface crack under the action of the tension propagate stably under the condition that the c/a (ratio of short axis to long axis of ellipse) is about 0.3. The safety assessment of K-joint with different lengths crack is presented according to the 2A failure assessment diagram of BS7910, and the critical crack of K-joint under different loads can be obtained.

Assessing Student Perceptions of School Victimization and School Safety: A Psychometric Assessment of Relevant Instruments

ERIC Educational Resources Information Center

Soderstrom, Irina R.; Elrod, Preston

2006-01-01

In an effort to assess students' perceptions of victimization in their schools, as well as their schools' safety, over 1,900 students from elementary, middle, high, and alternative schools were administered a 154-item questionnaire. The responses on the items were used to establish the psychometric properties of 19 theoretically driven scales and…

Guiding principles for the implementation of non-animal safety assessment approaches for cosmetics: skin sensitisation.

PubMed

Goebel, Carsten; Aeby, Pierre; Ade, Nadège; Alépée, Nathalie; Aptula, Aynur; Araki, Daisuke; Dufour, Eric; Gilmour, Nicola; Hibatallah, Jalila; Keller, Detlef; Kern, Petra; Kirst, Annette; Marrec-Fairley, Monique; Maxwell, Gavin; Rowland, Joanna; Safford, Bob; Schellauf, Florian; Schepky, Andreas; Seaman, Chris; Teichert, Thomas; Tessier, Nicolas; Teissier, Silvia; Weltzien, Hans Ulrich; Winkler, Petra; Scheel, Julia

2012-06-01

Characterisation of skin sensitisation potential is a key endpoint for the safety assessment of cosmetic ingredients especially when significant dermal exposure to an ingredient is expected. At present the mouse local lymph node assay (LLNA) remains the 'gold standard' test method for this purpose however non-animal test methods are under development that aim to replace the need for new animal test data. COLIPA (the European Cosmetics Association) funds an extensive programme of skin sensitisation research, method development and method evaluation and helped coordinate the early evaluation of the three test methods currently undergoing pre-validation. In May 2010, a COLIPA scientific meeting was held to analyse to what extent skin sensitisation safety assessments for cosmetic ingredients can be made in the absence of animal data. In order to propose guiding principles for the application and further development of non-animal safety assessment strategies it was evaluated how and when non-animal test methods, predictions based on physico-chemical properties (including in silico tools), threshold concepts and weight-of-evidence based hazard characterisation could be used to enable safety decisions. Generation and assessment of potency information from alternative tools which at present is predominantly derived from the LLNA is considered the future key research area. Copyright © 2012 Elsevier Inc. All rights reserved.

Assessing misclassification of vaccination status: Implications for studies of the safety of the childhood immunization schedule.

PubMed

Daley, Matthew F; Glanz, Jason M; Newcomer, Sophia R; Jackson, Michael L; Groom, Holly C; Lugg, Marlene M; McLean, Huong Q; Klein, Nicola P; Weintraub, Eric S; McNeil, Michael M

2017-04-04

To address public concern about the safety of the childhood immunization schedule, the Institute of Medicine recommended observational studies comparing adverse health outcomes of fully vaccinated children to children under-vaccinated due to parental choice. Misclassification of vaccination status could bias such studies. To assess risk of misclassification of vaccination status within the Vaccine Safety Datalink (VSD). A retrospective cohort study was conducted in three phases. In phase 1, electronic health record (EHR) data were used to identify patterns of under-vaccination during the first 24months of life potentially due to parental choice. In phase 2, a random sample of records of under-vaccinated children was manually reviewed. In phase 3, a separate sample of parents were surveyed to assess whether EHR data accurately reflected their child's vaccination status. Phases 1 and 2 were conducted at 6 VSD sites, phase 3 at 1 site. The study cohort included 361,901 children born 2004 through 2012. By 24months of age, 198,249 (54.8%) were fully vaccinated with no delays, 84,698 (23.4%) experienced delays but were fully vaccinated by 24months of age, 4865 (1.3%) received no vaccines, 3789 (1.0%) delayed starting vaccination until ≥4months of age, 4781 (1.3%) had consistent vaccine-limiting (≤2 vaccines per visit), and the remaining 65,519 (18.1%) were missing vaccine series or doses. When a diagnosis code for vaccine refusal was present in EHR data, encounter notes confirmed vaccine refusal as the reason for under-vaccination for nearly 100% of sampled records. Parent surveys confirmed these findings. Parents of under-vaccinated children were more likely to report visiting an alternative medical provider than parents of fully vaccinated children. Specific groups of children, under-vaccinated due to parental choice, can be identified with relatively low likelihood of misclassification of vaccination status using EHR-based vaccine data and diagnosis codes

A National Estimate of Performance: Statewide Highway Safety Program Assessment.

ERIC Educational Resources Information Center

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

A nationwide systematic approach to assess the developments and achievements of highway safety activities was conducted to measure program outputs from 1969 through 1974 using key indicators of performance such as ratios and percentages. A sample of 10 states was selected with overall sample of 105 local jurisdictions which would provide estimated…

INPRO Assessment of an INS in the Area of Safety of Fuel Cycle Installations

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

Raj, B.; Busurin, Y.; Depisch, F.

2006-07-01

INPRO has defined requirements organized in a hierarchy of Basic Principles, User Requirements and Criteria (consisting of an indicator and an acceptance limit) to be met by innovative nuclear reactor systems (INS) in six areas, namely: economics, safety, waste management, environment, proliferation resistance, and infrastructure. If an INS meets all requirements in all areas it represents a sustainable system for the supply of energy, capable of making a significant contribution to meeting the energy needs of the 21. century. Draft manuals have been developed, for each INPRO area, to provide guidance for performing an assessment of whether an INS meetsmore » the INPRO requirements in a given area. The manuals set out the information that needs to be assembled to perform an assessment and provide guidance on selecting the acceptance limits and, for a given INS, for determining the value of the indicators for comparison with the associated acceptance limits. Each manual also includes an example of a specific assessment to illustrate the guidance. This paper discusses the manual for performing an INPRO assessment in the area of safety of fuel cycle installations. The example, chosen solely for the purpose of illustrating the INPRO methodology, describes an assessment of an MOX fuel fabrication plant based on sol-gel technology and illustrates an assessment performed for an INS at an early stage of development. The safety issues and the assessment steps are presented in detail in the paper. (authors)« less

Safety assessment on pedestrian crossing environments using MLS data.

PubMed

Soilán, Mario; Riveiro, Belén; Sánchez-Rodríguez, Ana; Arias, Pedro

2018-02-01

In the framework of infrastructure analysis and maintenance in an urban environment, it is important to address the safety of every road user. This paper presents a methodology for the evaluation of several safety indicators on pedestrian crossing environments using geometric and radiometric information extracted from 3D point clouds collected by a Mobile Mapping System (MMS). The methodology is divided in four main modules which analyze the accessibility of the crossing area, the presence of traffic lights and traffic signs, and the visibility between a driver and a pedestrian on the proximities of a pedestrian crossing. The outputs of the analysis are exported to a Geographic Information System (GIS) where they are visualized and can be further processed in the context of city management. The methodology has been tested on approximately 30 pedestrian crossings in cluttered urban environments of two different cities. Results show that MMS are a valid mean to assess the safety of a specific urban environment, regarding its geometric conditions. Remarkable results are presented on traffic light classification, with a global F-score close to 95%. Copyright © 2017 Elsevier Ltd. All rights reserved.

Amended Safety Assessment of Isethionate Salts as Used in Cosmetics.

PubMed

Burnett, Christina L; 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

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) rereviewed the safety of 12 isethionate salts as used in cosmetics and concluded that these ingredients are safe in the present practices of use and concentration, when formulated to be nonirritating. These isethionate salts are reported to function mostly as surfactants and cleansing agents in cosmetic products. The Panel reviewed the available animal and clinical data as well as information from previous CIR reports. Although there are data gaps, the shared chemical core structure, expected similarities in physicochemical properties, and similar functions and concentrations in cosmetics enabled grouping these ingredients and reading across the available toxicological data to support the safety assessment of each ingredient.

Development of Safety Assessment Code for Decommissioning of Nuclear Facilities

NASA Astrophysics Data System (ADS)

Shimada, Taro; Ohshima, Soichiro; Sukegawa, Takenori

A safety assessment code, DecDose, for decommissioning of nuclear facilities has been developed, based on the experiences of the decommissioning project of Japan Power Demonstration Reactor (JPDR) at Japan Atomic Energy Research Institute (currently JAEA). DecDose evaluates the annual exposure dose of the public and workers according to the progress of decommissioning, and also evaluates the public dose at accidental situations including fire and explosion. As for the public, both the internal and the external doses are calculated by considering inhalation, ingestion, direct radiation from radioactive aerosols and radioactive depositions, and skyshine radiation from waste containers. For external dose for workers, the dose rate from contaminated components and structures to be dismantled is calculated. Internal dose for workers is calculated by considering dismantling conditions, e.g. cutting speed, cutting length of the components and exhaust velocity. Estimation models for dose rate and staying time were verified by comparison with the actual external dose of workers which were acquired during JPDR decommissioning project. DecDose code is expected to contribute the safety assessment for decommissioning of nuclear facilities.

Assessing Patient Activation among High-Need, High-Cost Patients in Urban Safety Net Care Settings.

PubMed

Napoles, Tessa M; Burke, Nancy J; Shim, Janet K; Davis, Elizabeth; Moskowitz, David; Yen, Irene H

2017-12-01

We sought to examine the literature using the Patient Activation Measure (PAM) or the Patient Enablement Instrument (PEI) with high-need, high-cost (HNHC) patients receiving care in urban safety net settings. Urban safety net care management programs serve low-income, racially/ethnically diverse patients living with multiple chronic conditions. Although many care management programs track patient progress with the PAM or the PEI, it is not clear whether the PAM or the PEI is an effective and appropriate tool for HNHC patients receiving care in urban safety net settings in the United States. We searched PubMed, EMBASE, Web of Science, and PsycINFO for articles published between 2004 and 2015 that used the PAM and between 1998 and 2015 that used the PEI. The search was limited to English-language articles conducted in the United States and published in peer-reviewed journals. To assess the utility of the PAM and the PEI in urban safety net care settings, we defined a HNHC patient sample as racially/ethnically diverse, low socioeconomic status (SES), and multimorbid. One hundred fourteen articles used the PAM. All articles using the PEI were conducted outside the U.S. and therefore were excluded. Nine PAM studies (8%) included participants similar to those receiving care in urban safety net settings, three of which were longitudinal. Two of the three longitudinal studies reported positive changes following interventions. Our results indicate that research on patient activation is not commonly conducted on racially and ethnically diverse, low SES, and multimorbid patients; therefore, there are few opportunities to assess the appropriateness of the PAM in such populations. Investigators expressed concerns with the potential unreliability and inappropriate nature of the PAM on multimorbid, older, and low-literacy patients. Thus, the PAM may not be able to accurately assess patient progress among HNHC patients receiving care in urban safety net settings. Assessing

Environmental, health and safety assessment of photovoltaics

NASA Technical Reports Server (NTRS)

Rose, E. C.

1983-01-01

The environmental, health, and safety (E, H and S) concerns associated with the fabrication, deployment, and decommissioning of photovoltaic (PV) systems in terrestial applications are identified and assessed. Discussion is limited to crystalline silicon technologies. The primary E, H, and S concerns that arise during collector fabrication are associated with occupational exposure to materials of undetermined toxicity or to materials that are known to be hazardous, but for which process control technology may be inadequate. Stricter exposure standards are anticipated for some materials and may indicate a need for further control technology development. Minimizing electric shock hazards is a significant concern during system construction, operation and maintenance, and decommissioning.

Leading a Classroom Discussion: Definition, Supportive Evidence, and Measurement of the "ETS"® National Observational Teaching Examination (NOTE) Assessment Series. Research Memorandum No. RM-16-09

ERIC Educational Resources Information Center

Witherspoon, Margaret; Sykes, Gary; Bell, Courtney

2016-01-01

This paper provides a description and rationale for a performance assessment of a teaching practice--leading a classroom discussion (LCD)--included in the ETS® National Observational Teaching Examination (NOTE) assessment series. In this assessment, candidates interact with a small class of virtual students represented by avatars in a…

Relationship between Risk Assessment and Compliance to Health and Safety in Ugandan Secondary Schools

ERIC Educational Resources Information Center

Sekiwu, Denis; Kabanda, Milly; Naluwemba, Esther Frances; Kaggwa, Victoria Tamale

2015-01-01

Health hazards are part and parcel of human life necessitating the provision of safety in every organizational environment (WHO regional Office for Africa, 2004). Likewise, the area of safety and accident prevention is of great concern to school improvement. The study sought to investigate the relationship between Risk Assessment and Compliancy to…

NOTES: a review of the technical problems encountered and their solutions.

PubMed

Mintz, Yoav; Horgan, Santiago; Cullen, John; Stuart, David; Falor, Eric; Talamini, Mark A

2008-08-01

Natural orifice translumenal endoscopic surgery (NOTES) is currently investigated and developed worldwide. In the past few years, multiple groups have confronted this challenge. Many technical problems are encountered in this technique due to the currently available tools for this approach. Some of the unique technical problems in NOTES include: blindly performed primary incisions; uncontrolled pneumoperitoneal pressure; no support for the endoscope in the abdominal cavity; inadequate vision; insufficient illumination; limited retraction and exposure; and the complexity of suturing and performing a safe anastomosis. In this paper, we review the problems encountered in NOTES and provide possible temporary solutions. Acute and survival studies were performed on 15 farm pigs. The hybrid technique approach (i.e., endoscopic surgery with the aid of laparoscopic vision) was performed in all cases. Procedures performed included liver biopsies, bilateral tubal ligation, oophprectomy, cholecystectomy, splenectomy and small bowel resection, and anastomosis. All attempted procedures were successfully performed. New methods and techniques were developed to overcome the technical problems. Closure of the gastrotomy was achieved by T-bar sutures and by stapler closure of the stomach incision. Small bowel anastomosis was achieved by the dual-lumen NOTES technique. The hybrid technique serves as a temporary approach to aid in developing the NOTES technique. A rectal or vaginal port of entry enables and facilitates gastrointestinal NOTES by using available laparoscopic instruments. The common operations performed today in the laparoscopic fashion could be probably performed in the NOTES approach. The safety of these procedures, however, is yet to be determined.

Clinical Note Creation, Binning, and Artificial Intelligence.

PubMed

Deliberato, Rodrigo Octávio; Celi, Leo Anthony; Stone, David J

2017-08-03

The creation of medical notes in software applications poses an intrinsic problem in workflow as the technology inherently intervenes in the processes of collecting and assembling information, as well as the production of a data-driven note that meets both individual and healthcare system requirements. In addition, the note writing applications in currently available electronic health records (EHRs) do not function to support decision making to any substantial degree. We suggest that artificial intelligence (AI) could be utilized to facilitate the workflows of the data collection and assembly processes, as well as to support the development of personalized, yet data-driven assessments and plans. ©Rodrigo Octávio Deliberato, Leo Anthony Celi, David J Stone. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 03.08.2017.

49 CFR Appendix F to Part 236 - Minimum Requirements of FRA Directed Independent Third-Party Assessment of PTC System Safety...

Code of Federal Regulations, 2012 CFR

2012-10-01

... Third-Party Assessment of PTC System Safety Verification and Validation F Appendix F to Part 236... Safety Verification and Validation (a) This appendix provides minimum requirements for mandatory independent third-party assessment of PTC system safety verification and validation pursuant to subpart H or I...

49 CFR Appendix F to Part 236 - Minimum Requirements of FRA Directed Independent Third-Party Assessment of PTC System Safety...

Code of Federal Regulations, 2014 CFR

2014-10-01

... Third-Party Assessment of PTC System Safety Verification and Validation F Appendix F to Part 236... Safety Verification and Validation (a) This appendix provides minimum requirements for mandatory independent third-party assessment of PTC system safety verification and validation pursuant to subpart H or I...

49 CFR Appendix F to Part 236 - Minimum Requirements of FRA Directed Independent Third-Party Assessment of PTC System Safety...

Code of Federal Regulations, 2011 CFR

2011-10-01

... Third-Party Assessment of PTC System Safety Verification and Validation F Appendix F to Part 236... Safety Verification and Validation (a) This appendix provides minimum requirements for mandatory independent third-party assessment of PTC system safety verification and validation pursuant to subpart H or I...

49 CFR Appendix F to Part 236 - Minimum Requirements of FRA Directed Independent Third-Party Assessment of PTC System Safety...

Code of Federal Regulations, 2013 CFR

2013-10-01

... Third-Party Assessment of PTC System Safety Verification and Validation F Appendix F to Part 236... Safety Verification and Validation (a) This appendix provides minimum requirements for mandatory independent third-party assessment of PTC system safety verification and validation pursuant to subpart H or I...

Does Employee Safety Matter for Patients Too? Employee Safety Climate and Patient Safety Culture in Health Care.

PubMed

Mohr, David C; Eaton, Jennifer Lipkowitz; McPhaul, Kathleen M; Hodgson, Michael J

2015-04-22

We examined relationships between employee safety climate and patient safety culture. Because employee safety may be a precondition for the development of patient safety, we hypothesized that employee safety culture would be strongly and positively related to patient safety culture. An employee safety climate survey was administered in 2010 and assessed employees' views and experiences of safety for employees. The patient safety survey administered in 2011 assessed the safety culture for patients. We performed Pearson correlations and multiple regression analysis to examine the relationships between a composite measure of employee safety with subdimensions of patient safety culture. The regression models controlled for size, geographic characteristics, and teaching affiliation. Analyses were conducted at the group level using data from 132 medical centers. Higher employee safety climate composite scores were positively associated with all 9 patient safety culture measures examined. Standardized multivariate regression coefficients ranged from 0.44 to 0.64. Medical facilities where staff have more positive perceptions of health care workplace safety climate tended to have more positive assessments of patient safety culture. This suggests that patient safety culture and employee safety climate could be mutually reinforcing, such that investments and improvements in one domain positively impacts the other. Further research is needed to better understand the nexus between health care employee and patient safety to generalize and act upon findings.

Patient Safety Culture Assessment in Oman

PubMed Central

Al-Mandhari, Ahmed; Al-Zakwani, Ibrahim; Al-Kindi, Moosa; Tawilah, Jihane; Dorvlo, Atsu S.S.; Al-Adawi, Samir

2014-01-01

Objective To illustrate the patient safety culture in Oman as gleaned via 12 indices of patient safety culture derived from the Hospital Survey on Patient Safety Culture (HSPSC) and to compare the average positive response rates in patient safety culture between Oman and the USA, Taiwan, and Lebanon. Methods This was a cross-sectional research study employed to gauge the performance of HSPSC safety indices among health workers representing five secondary and tertiary care hospitals in the northern region of Oman. The participants (n=398) represented different professional designations of hospital staff. Analyses were performed using univariate statistics. Results The overall average positive response rate for the 12 patient safety culture dimensions of the HSPSC survey in Oman was 58%. The indices from HSPSC that were endorsed the highest included ‘organizational learning and continuous improvement’ while conversely, ‘non-punitive response to errors’ was ranked the least. There were no significant differences in average positive response rates between Oman and the United States (58% vs. 61%; p=0.666), Taiwan (58% vs. 64%; p=0.386), and Lebanon (58% vs. 61%; p=0.666). Conclusion This study provides the first empirical study on patient safety culture in Oman which is similar to those rates reported elsewhere. It highlights the specific strengths and weaknesses which may stem from the specific milieu prevailing in Oman. PMID:25170407

Patient safety culture assessment in oman.

PubMed

Al-Mandhari, Ahmed; Al-Zakwani, Ibrahim; Al-Kindi, Moosa; Tawilah, Jihane; Dorvlo, Atsu S S; Al-Adawi, Samir

2014-07-01

To illustrate the patient safety culture in Oman as gleaned via 12 indices of patient safety culture derived from the Hospital Survey on Patient Safety Culture (HSPSC) and to compare the average positive response rates in patient safety culture between Oman and the USA, Taiwan, and Lebanon. This was a cross-sectional research study employed to gauge the performance of HSPSC safety indices among health workers representing five secondary and tertiary care hospitals in the northern region of Oman. The participants (n=398) represented different professional designations of hospital staff. Analyses were performed using univariate statistics. The overall average positive response rate for the 12 patient safety culture dimensions of the HSPSC survey in Oman was 58%. The indices from HSPSC that were endorsed the highest included 'organizational learning and continuous improvement' while conversely, 'non-punitive response to errors' was ranked the least. There were no significant differences in average positive response rates between Oman and the United States (58% vs. 61%; p=0.666), Taiwan (58% vs. 64%; p=0.386), and Lebanon (58% vs. 61%; p=0.666). This study provides the first empirical study on patient safety culture in Oman which is similar to those rates reported elsewhere. It highlights the specific strengths and weaknesses which may stem from the specific milieu prevailing in Oman.

Safety assessment for the postictal confusional phase following complex partial seizure.

PubMed

Tucker, C

1985-06-01

Misunderstanding of the postictal confusional state that follows the complex partial seizure has caused emotional and physical harm to patients. Concern about this phenomenon and its effects upon the patient prompted this study to explore, describe, and document one method of intervention to lessen these harmful effects. An evaluative descriptive research design was employed to assess patient safety during and after the postictal confusional phase following a complex partial seizure. A closed-structured questionnaire and participant observation were the methods used to collect data for this study. A Level of Safety Tool was specifically designed for this study.

Progress of IRSN R&D on ITER Safety Assessment

NASA Astrophysics Data System (ADS)

Van Dorsselaere, J. P.; Perrault, D.; Barrachin, M.; Bentaib, A.; Gensdarmes, F.; Haeck, W.; Pouvreau, S.; Salat, E.; Seropian, C.; Vendel, J.

2012-08-01

The French "Institut de Radioprotection et de Sûreté Nucléaire" (IRSN), in support to the French "Autorité de Sûreté Nucléaire", is analysing the safety of ITER fusion installation on the basis of the ITER operator's safety file. IRSN set up a multi-year R&D program in 2007 to support this safety assessment process. Priority has been given to four technical issues and the main outcomes of the work done in 2010 and 2011 are summarized in this paper: for simulation of accident scenarios in the vacuum vessel, adaptation of the ASTEC system code; for risk of explosion of gas-dust mixtures in the vacuum vessel, adaptation of the TONUS-CFD code for gas distribution, development of DUST code for dust transport, and preparation of IRSN experiments on gas inerting, dust mobilization, and hydrogen-dust mixtures explosion; for evaluation of the efficiency of the detritiation systems, thermo-chemical calculations of tritium speciation during transport in the gas phase and preparation of future experiments to evaluate the most influent factors on detritiation; for material neutron activation, adaptation of the VESTA Monte Carlo depletion code. The first results of these tasks have been used in 2011 for the analysis of the ITER safety file. In the near future, this R&D global programme may be reoriented to account for the feedback of the latter analysis or for new knowledge.

Preliminary Assessment of Operational Hazards and Safety Requirements for Airborne Trajectory Management (ABTM) Roadmap Applications

NASA Technical Reports Server (NTRS)

Cotton, William B.; Hilb, Robert; Koczo, Stefan, Jr.; Wing, David J.

2016-01-01

A set of five developmental steps building from the NASA TASAR (Traffic Aware Strategic Aircrew Requests) concept are described, each providing incrementally more efficiency and capacity benefits to airspace system users and service providers, culminating in a Full Airborne Trajectory Management capability. For each of these steps, the incremental Operational Hazards and Safety Requirements are identified for later use in future formal safety assessments intended to lead to certification and operational approval of the equipment and the associated procedures. Two established safety assessment methodologies that are compliant with the FAA's Safety Management System were used leading to Failure Effects Classifications (FEC) for each of the steps. The most likely FEC for the first three steps, Basic TASAR, Digital TASAR, and 4D TASAR, is "No effect". For step four, Strategic Airborne Trajectory Management, the likely FEC is "Minor". For Full Airborne Trajectory Management (Step 5), the most likely FEC is "Major".

Framework for continuous assessment and improvement of occupational health and safety issues in construction companies.

PubMed

Mahmoudi, Shahram; Ghasemi, Fakhradin; Mohammadfam, Iraj; Soleimani, Esmaeil

2014-09-01

Construction industry is among the most hazardous industries, and needs a comprehensive and simple-to-administer tool to continuously assess and promote its health and safety performance. Through the study of various standard systems (mainly Health, Safety, and Environment Management System; Occupational Health and Safety Assessment Series 180001; and British Standard, occupational health and safety management systems-Guide 8800), seven main elements were determined for the desired framework, and then, by reviewing literature, factors affecting these main elements were determined. The relative importance of each element and its related factors was calculated at organizational and project levels. The provided framework was then implemented in three construction companies, and results were compared together. THE RESULTS OF THE STUDY SHOW THAT THE RELATIVE IMPORTANCE OF THE MAIN ELEMENTS AND THEIR RELATED FACTORS DIFFER BETWEEN ORGANIZATIONAL AND PROJECT LEVELS: leadership and commitment are the most important elements at the organization level, whereas risk assessment and management are most important at the project level. The present study demonstrated that the framework is easy to administer, and by interpreting the results, the main factors leading to the present condition of companies can be determined.

Evaluation of experimental methods for assessing safety for ultrasound radiation force elastography.

PubMed

Skurczynski, M J; Duck, F A; Shipley, J A; Bamber, J C; Melodelima, D

2009-08-01

Standard test tools have been evaluated for the assessment of safety associated with a prototype transducer intended for a novel radiation force elastographic imaging system. In particular, safety has been evaluated by direct measurement of temperature rise, using a standard thermal test object, and detection of inertial cavitation from acoustic emission. These direct measurements have been compared with values of the thermal index and mechanical index, calculated from acoustic measurements in water using standard formulae. It is concluded that measurements using a thermal test object can be an effective alternative to the calculation of thermal index for evaluating thermal hazard. Measurement of the threshold for cavitation was subject to considerable variability, and it is concluded that the mechanical index still remains the preferred standard means for assessing cavitation hazard.

Developing a model for hospital inherent safety assessment: Conceptualization and validation.

PubMed

Yari, Saeed; Akbari, Hesam; Gholami Fesharaki, Mohammad; Khosravizadeh, Omid; Ghasemi, Mohammad; Barsam, Yalda; Akbari, Hamed

2018-01-01

Paying attention to the safety of hospitals, as the most crucial institute for providing medical and health services wherein a bundle of facilities, equipment, and human resource exist, is of significant importance. The present research aims at developing a model for assessing hospitals' safety based on principles of inherent safety design. Face validity (30 experts), content validity (20 experts), construct validity (268 examples), convergent validity, and divergent validity have been employed to validate the prepared questionnaire; and the items analysis, the Cronbach's alpha test, ICC test (to measure reliability of the test), composite reliability coefficient have been used to measure primary reliability. The relationship between variables and factors has been confirmed at 0.05 significance level by conducting confirmatory factor analysis (CFA) and structural equations modeling (SEM) technique with the use of Smart-PLS. R-square and load factors values, which were higher than 0.67 and 0.300 respectively, indicated the strong fit. Moderation (0.970), simplification (0.959), substitution (0.943), and minimization (0.5008) have had the most weights in determining the inherent safety of hospital respectively. Moderation, simplification, and substitution, among the other dimensions, have more weight on the inherent safety, while minimization has the less weight, which could be due do its definition as to minimize the risk.

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.

Health, safety and environmental unit performance assessment model under uncertainty (case study: steel industry).

PubMed

Shamaii, Azin; Omidvari, Manouchehr; Lotfi, Farhad Hosseinzadeh

2017-01-01

Performance assessment is a critical objective of management systems. As a result of the non-deterministic and qualitative nature of performance indicators, assessments are likely to be influenced by evaluators' personal judgments. Furthermore, in developing countries, performance assessments by the Health, Safety and Environment (HSE) department are based solely on the number of accidents. A questionnaire is used to conduct the study in one of the largest steel production companies in Iran. With respect to health, safety, and environment, the results revealed that control of disease, fire hazards, and air pollution are of paramount importance, with coefficients of 0.057, 0.062, and 0.054, respectively. Furthermore, health and environment indicators were found to be the most common causes of poor performance. Finally, it was shown that HSE management systems can affect the majority of performance safety indicators in the short run, whereas health and environment indicators require longer periods of time. The objective of this study is to present an HSE-MS unit performance assessment model in steel industries. Moreover, we seek to answer the following question: what are the factors that affect HSE unit system in the steel industry? Also, for each factor, the extent of impact on the performance of the HSE management system in the organization is determined.

Corporate Functional Management Evaluation of the LLNL Radiation Safety Organization

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

Sygitowicz, L S

2008-03-20

A Corporate Assess, Improve, and Modernize review was conducted at Lawrence Livermore National Laboratory (LLNL) to evaluate the LLNL Radiation Safety Program and recommend actions to address the conditions identified in the Internal Assessment conducted July 23-25, 2007. This review confirms the findings of the Internal Assessment of the Institutional Radiation Safety Program (RSP) including the noted deficiencies and vulnerabilities to be valid. The actions recommended are a result of interviews with about 35 individuals representing senior management through the technician level. The deficiencies identified in the LLNL Internal Assessment of the Institutional Radiation Safety Program were discussed with Radiationmore » Safety personnel team leads, customers of Radiation Safety Program, DOE Livermore site office, and senior ES&H management. There are significant issues with the RSP. LLNL RSP is not an integrated, cohesive, consistently implemented program with a single authority that has the clear roll and responsibility and authority to assure radiological operations at LLNL are conducted in a safe and compliant manner. There is no institutional commitment to address the deficiencies that are identified in the internal assessment. Some of these deficiencies have been previously identified and corrective actions have not been taken or are ineffective in addressing the issues. Serious funding and staffing issues have prevented addressing previously identified issues in the Radiation Calibration Laboratory, Internal Dosimetry, Bioassay Laboratory, and the Whole Body Counter. There is a lack of technical basis documentation for the Radiation Calibration Laboratory and an inadequate QA plan that does not specify standards of work. The Radiation Safety Program lack rigor and consistency across all supported programs. The implementation of DOE Standard 1098-99 Radiological Control can be used as a tool to establish this consistency across LLNL. The establishment of a

Recent Developments in Hyperspectral Imaging for Assessment of Food Quality and Safety

PubMed Central

Huang, Hui; Liu, Li; Ngadi, Michael O.

2014-01-01

Hyperspectral imaging which combines imaging and spectroscopic technology is rapidly gaining ground as a non-destructive, real-time detection tool for food quality and safety assessment. Hyperspectral imaging could be used to simultaneously obtain large amounts of spatial and spectral information on the objects being studied. This paper provides a comprehensive review on the recent development of hyperspectral imaging applications in food and food products. The potential and future work of hyperspectral imaging for food quality and safety control is also discussed. PMID:24759119

Randomized clinical trials and observational studies in the assessment of drug safety.

PubMed

Sawchik, J; Hamdani, J; Vanhaeverbeek, M

2018-05-01

Randomized clinical trials are considered as the preferred design to assess the potential causal relationships between drugs or other medical interventions and intended effects. For this reason, randomized clinical trials are generally the basis of development programs in the life cycle of drugs and the cornerstone of evidence-based medicine. Instead, randomized clinical trials are not the design of choice for the detection and assessment of rare, delayed and/or unexpected effects related to drug safety. Moreover, the highly homogeneous populations resulting from restrictive eligibility criteria make randomized clinical trials inappropriate to describe comprehensively the safety profile of drugs. In that context, observational studies have a key added value when evaluating the benefit-risk balance of the drugs. However, observational studies are more prone to bias than randomized clinical trials and they have to be designed, conducted and reported judiciously. In this article, we discuss the strengths and limitations of randomized clinical trials and of observational studies, more particularly regarding their contribution to the knowledge of medicines' safety profile. In addition, we present general recommendations for the sensible use of observational data. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Note Taking on Trial: A Legal Application of Note-Taking Research

ERIC Educational Resources Information Center

Kiewra, Kenneth A.

2016-01-01

This article is about note taking, but it is not an exhaustive review of note-taking literature. Instead, it portrays the application of note-taking research to an unusual and important area of practice--the law. I was hired to serve as an expert witness on note taking in a legal case that hinged, in part, on the completeness and accuracy of…

Launch Services Safety Overview

NASA Technical Reports Server (NTRS)

Loftin, Charles E.

2008-01-01

NASA/KSC Launch Services Division Safety (SA-D) services include: (1) Assessing the safety of the launch vehicle (2) Assessing the safety of NASA ELV spacecraft (S/C) / launch vehicle (LV) interfaces (3) Assessing the safety of spacecraft processing to ensure resource protection of: - KSC facilities - KSC VAFB facilities - KSC controlled property - Other NASA assets (4) NASA personnel safety (5) Interfacing with payload organizations to review spacecraft for adequate safety implementation and compliance for integrated activities (6) Assisting in the integration of safety activities between the payload, launch vehicle, and processing facilities

ANALYSIS OF SEQUENTIAL FAILURES FOR ASSESSMENT OF RELIABILITY AND SAFETY OF MANUFACTURING SYSTEMS. (R828541)

EPA Science Inventory

Assessment of reliability and safety of a manufacturing system with sequential failures is an important issue in industry, since the reliability and safety of the system depend not only on all failed states of system components, but also on the sequence of occurrences of those...

GCSE Assessment Notes: Six GCSE Assessment Assignments.

ERIC Educational Resources Information Center

Graham, Stephen

1988-01-01

Provided are copy masters, instructions for use, and grading criteria for six problems used as part of the practical assessment for a modular science course. Each problem gives a narrative and a list of materials necessary to complete the problem. (CW)

An Employee Questionnaire for Assessing Patient Safety in Outpatient Surgery

DTIC Science & Technology

2005-01-01

461 An Employee Questionnaire for Assessing Patient Safety in Outpatient Surgery Pascale Carayon, Carla J. Alvarado, Ann Schoofs Hundt, Scott...Springman, Amanda Borgsdorf, Peter L.T. Hoonakker Abstract This paper provides information on the reliability and validity of an employee ...intervention on both employees and patients. In this paper, we describe the SEIPS employee questionnaire, which surveys various elements of the work system

Assessing the Food Safety Knowledge of University of Maine Students

ERIC Educational Resources Information Center

Ferk, Chelsea C.; Calder, Beth L.; Camire, Mary Ellen

2016-01-01

Foodborne illness is a global public health issue. Young adults may work in foodservice while they are university students, and their habits may later shape the practices and well-being of their children. The objective of this study was to establish baseline data and assess the food safety knowledge of 18- to 26-year-old Univ. of Maine students.…

An assessment of food hygiene and safety at farmers' markets.

PubMed

Worsfold, D; Worsfold, P M; Griffith, C J

2004-04-01

Farmers' markets are becoming a more significant part of the food-retailing sector. A survey of farmers' markets was conducted to assess aspects of food hygiene and safety. The views of the public using the markets were also examined. The range of farm products was wide and the methods utilised varied. The markets were usually temporary outdoor events with few facilities. Traders had received elementary food hygiene training and rated their hygiene standards highly. Less than half had risk management procedures in place, most did not perceive their produce as high-risk. They believed consumers to be mainly interested in food quality and to regard food safety issues highly. Consumers shopped at the markets because of the quality of the products sold. Their overall satisfaction with the markets was high and they raised no concerns about food safety. Given the restricted facilities at farmers' markets and the early phase of implementation of hygiene management systems by market traders, it may be precautionary to restrict the sale of farm products at farmers markets to those that are regarded as low-risk.

The role of PRA in the safety assessment of VVER Nuclear Power Plants in Ukraine.

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

Kot, C.

1999-05-10

Ukraine operates thirteen (13) Soviet-designed pressurized water reactors, VVERS. All Ukrainian plants are currently operating with annually renewable permits until they update their safety analysis reports (SARs), in accordance with new SAR content requirements issued in September 1995, by the Nuclear Regulatory Authority and the Government Nuclear Power Coordinating Committee of Ukraine. The requirements are in three major areas: design basis accident (DBA) analysis, probabilistic risk assessment (PRA), and beyond design-basis accident (BDBA) analysis. The last two requirements, on PRA and BDBA, are new, and the DBA requirements are an expanded version of the older SAR requirements. The US Departmentmore » of Energy (USDOE), as part of its Soviet-Designed Reactor Safety activities, is providing assistance and technology transfer to Ukraine to support their nuclear power plants (NPPs) in developing a Western-type technical basis for the new SARs. USDOE sponsored In-Depth Safety Assessments (ISAs) are in progress at three pilot nuclear reactor units in Ukraine, South Ukraine Unit 1, Zaporizhzhya Unit 5, and Rivne Unit 1, and a follow-on study has been initiated at Khmenytskyy Unit 1. The ISA projects encompass most areas of plant safety evaluation, but the initial emphasis is on performing a detailed, plant-specific Level 1 Internal Events PRA. This allows the early definition of the plant risk profile, the identification of risk significant accident sequences and plant vulnerabilities and provides guidance for the remainder of the safety assessments.« less

The Cosmetic Ingredient Review Program-Expert Safety Assessments of Cosmetic Ingredients in an Open Forum.

PubMed

Boyer, Ivan J; Bergfeld, Wilma F; Heldreth, Bart; Fiume, Monice M; Gill, Lillian J

The Cosmetic Ingredient Review (CIR) is a nonprofit program to assess the safety of ingredients in personal care products in an open, unbiased, and expert manner. Cosmetic Ingredient Review was established in 1976 by the Personal Care Products Council (PCPC), with the support of the US Food and Drug Administration (USFDA) and the Consumer Federation of America (CFA). Cosmetic Ingredient Review remains the only scientific program in the world committed to the systematic, independent review of cosmetic ingredient safety in a public forum. Cosmetic Ingredient Review operates in accordance with procedures modeled after the USFDA process for reviewing over-the-counter drugs. Nine voting panel members are distinguished, such as medical professionals, scientists, and professors. Three nonvoting liaisons are designated by the USFDA, CFA, and PCPC to represent government, consumer, and industry, respectively. The annual rate of completing safety assessments accelerated from about 100 to more than 400 ingredients by implementing grouping and read-across strategies and other approaches. As of March 2017, CIR had reviewed 4,740 individual cosmetic ingredients, including 4,611 determined to be safe as used or safe with qualifications, 12 determined to be unsafe, and 117 ingredients for which the information is insufficient to determine safety. Examples of especially challenging safety assessments and issues are presented here, including botanicals. Cosmetic Ingredient Review continues to strengthen its program with the ongoing cooperation of the USFDA, CFA, the cosmetics industry, and everyone else interested in contributing to the process.

Hazard Identification and Risk Assessment in Water Treatment Plant considering Environmental Health and Safety Practice

NASA Astrophysics Data System (ADS)

Falakh, Fajrul; Setiani, Onny

2018-02-01

Water Treatment Plant (WTP) is an important infrastructure to ensure human health and the environment. In its development, aspects of environmental safety and health are of concern. This paper case study was conducted at the Water Treatment Plant Company in Semarang, Central Java, Indonesia. Hazard identification and risk assessment is one part of the occupational safety and health program at the risk management stage. The purpose of this study was to identify potential hazards using hazard identification methods and risk assessment methods. Risk assessment is done using criteria of severity and probability of accident. The results obtained from this risk assessment are 22 potential hazards present in the water purification process. Extreme categories that exist in the risk assessment are leakage of chlorine and industrial fires. Chlorine and fire leakage gets the highest value because its impact threatens many things, such as industrial disasters that could endanger human life and the environment. Control measures undertaken to avoid potential hazards are to apply the use of personal protective equipment, but management will also be better managed in accordance with hazard control hazards, occupational safety and health programs such as issuing work permits, emergency response training is required, Very useful in overcoming potential hazards that have been determined.

Eliciting Student Thinking: Definition, Research Support, and Measurement of the "ETS"® National Observational Teaching Examination (NOTE) Assessment Series. Research Memorandum No. RM-16-06

ERIC Educational Resources Information Center

Qi, Yi; Sykes, Gary

2016-01-01

This report describes and provides research and scholarly support for a core practice of teaching--eliciting student thinking (EST)--that is the target for a performance assessment contributing one component of the "ETS"® National Observational Teaching Examination (NOTE) assessment series. The purpose of this report is to review the…

Assessment of herbal medicinal products: Challenges, and opportunities to increase the knowledge base for safety assessment

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

Jordan, Scott A., E-mail: scott.jordan@hc-sc.gc.c; Cunningham, David G.; Marles, Robin J.

Although herbal medicinal products (HMP) have been perceived by the public as relatively low risk, there has been more recognition of the potential risks associated with this type of product as the use of HMPs increases. Potential harm can occur via inherent toxicity of herbs, as well as from contamination, adulteration, plant misidentification, and interactions with other herbal products or pharmaceutical drugs. Regulatory safety assessment for HMPs relies on both the assessment of cases of adverse reactions and the review of published toxicity information. However, the conduct of such an integrated investigation has many challenges in terms of the quantitymore » and quality of information. Adverse reactions are under-reported, product quality may be less than ideal, herbs have a complex composition and there is lack of information on the toxicity of medicinal herbs or their constituents. Nevertheless, opportunities exist to capitalise on newer information to increase the current body of scientific evidence. Novel sources of information are reviewed, such as the use of poison control data to augment adverse reaction information from national pharmacovigilance databases, and the use of more recent toxicological assessment techniques such as predictive toxicology and omics. The integration of all available information can reduce the uncertainty in decision making with respect to herbal medicinal products. The example of Aristolochia and aristolochic acids is used to highlight the challenges related to safety assessment, and the opportunities that exist to more accurately elucidate the toxicity of herbal medicines.« less

Nuclear criticality safety: 5-day training course

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

Schlesser, J.A.

1992-11-01

This compilation of notes is presented as a source reference for the criticality safety course. It represents the contributions of many people, particularly Tom McLaughlin, the course's primary instructor. At the completion of this training course, the attendee will: be able to define terms commonly used in nuclear criticality safety; be able to appreciate the fundamentals of nuclear criticality safety; be able to identify factors which affect nuclear criticality safety; be able to identify examples of criticality controls as used at Los Alamos; be able to identify examples of circumstances present during criticality accidents; be able to identify examples ofmore » computer codes used by the nuclear criticality safety specialist; be able to identify examples of safety consciousness required in nuclear criticality safety.« less

United States Postal Service Alaska Hovercraft Demonstration Project Technology and Safety Assessment

DOT National Transportation Integrated Search

2000-02-01

This report presents the results of the technology and safety assessment of the Bethel/Kuskokwim River hovercraft service,operated by the Alaska Hovercraft Joint Venture (AHJV). The primary purpose of the service was a two-year demonstration of bypas...

2013 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

Dumont, Alan G.

2013-01-01

Welcome to the 2013 edition of the NASA Range Safety Annual Report. Funded by NASA Headquarters, this report provides an Agency overview for current and potential range users. This report contains articles which cover a variety of subject areas, summaries of various activities performed during the past year, links to past reports, and information on several projects that may have a profound impact on the way business will be conducted in the future. Specific topics discussed in the 2013 NASA Range Safety Annual Report include a program overview and 2013 highlights, Range Safety Training, Independent Assessments, support to Program Operations at all ranges conducting NASA launch/flight operations, a continuing overview of emerging range safety-related technologies, and status reports from all of the NASA Centers that have Range Safety responsibilities. Every effort has been made to include the most current information available. We recommend this report be used only for guidance and that the validity and accuracy of all articles be verified for updates. As is the case each year, we had a wide variety of contributors to this report from across our NASA Centers and the national range safety community at large, and I wish to thank them all. On a sad note, we lost one of our close colleagues, Dr. Jim Simpson, due to his sudden passing in December. His work advancing the envelope of autonomous flight safety systems software/hardware development leaves a lasting impression on our community. Such systems are being flight tested today and may one day be considered routine in the range safety business. The NASA family has lost a pioneer in our field, and he will surely be missed. In conclusion, it has been a very busy and productive year, and I look forward to working with all of you in NASA Centers/Programs/Projects and with the national Range Safety community in making Flight/Space activities as safe as they can be in the upcoming year.

Assessment of occupational health and safety hazard exposures among working college students.

PubMed

Balanay, Jo Anne G; Adesina, Adepeju; Kearney, Gregory D; Richards, Stephanie L

2014-01-01

Adolescents and young adults have higher injury rates than their adult counterparts in similar jobs. This study used the working college student population to assess health and safety hazards in the workplace, characterize related occupational diseases and injuries, and describe worker health/safety activities provided by employers. College students (≥17 years old) were assessed via online surveys about work history, workplace exposure to hazards, occupational diseases/injuries, and workplace health/safety activities. Approximately half (51%) of participants (n = 1,147) were currently employed at the time of the survey or had been employed while enrolled in college. Restaurants (other than fast food) were the most frequently reported work setting. The most reported workplace hazards included noise exposure and contact with hot liquids/surfaces. Twenty percent of working students experienced injury at work; some injuries were severe enough to limit students' normal activities for >3 days (30%) or require medical attention (44%). Men had significantly higher prevalence of injuries (P = 0.05) and near-misses (P < 0.01) at work than women. Injury occurrence was associated with near-misses (AOR = 5.08, P < 0.01) and co-worker injuries (AOR = 3.19, P < 0.01) after gender and age adjustments. Most (77%) received worker safety training and half were given personal protective equipment (PPE) by their employers. Risk reduction from workplace injuries and illnesses among working college students may be achieved by implementing occupational health and safety (OHS) strategies including incorporation of OHS in the college curriculum, promotion of OHS by university/college student health services, and improving awareness of OHS online resources among college students, employers, and educators. © 2013 Wiley Periodicals, Inc.

Effectiveness of health and safety in small enterprises: a systematic review of quantitative evaluations of interventions.

PubMed

Breslin, F Curtis; Kyle, Natasha; Bigelow, Philip; Irvin, Emma; Morassaei, Sara; MacEachen, Ellen; Mahood, Quenby; Couban, Rachel; Shannon, Harry; Amick, Benjamin C

2010-06-01

This systematic review was conducted to identify effective occupational health and safety interventions for small businesses. The review focused on peer-reviewed intervention studies conducted in small businesses with 100 or fewer employees, that were published in English and several other languages, and that were not limited by publication date. Multidisciplinary members of the review team identified relevant articles and assessed their quality. Studies assessed as medium or high quality had data extracted, which was then synthesized. Five studies were deemed of medium or high quality, and proceeded to data extraction and evidence synthesis. The types of interventions identified: a combination of training and safety audits; and a combination of engineering, training, safety audits, and a motivational component, showed a limited amount of evidence in improving safety outcomes. Overall, this evidence synthesis found a moderate level of evidence for intervention effectiveness, and found no evidence that any intervention had adverse effects. Even though there were few studies that adequately evaluated small business intervention, several studies demonstrate that well-designed evaluations are possible with small businesses. While stronger levels of evidence are required to make recommendations, these interventions noted above were associated with positive changes in safety-related attitudes and beliefs and workplace parties should be aware of them.

Use of System Safety Risk Assessments for the Space Shuttle Reusable Solid Rocket Motor (RSRM)

NASA Technical Reports Server (NTRS)

Greenhalgh, Phillip O.; McCool, Alex (Technical Monitor)

2001-01-01

This paper discusses the System Safety approach used to assess risk for the Space Shuttle Reusable Solid Rocket Motor (RSRM). Previous to the first RSRM flight in the fall of 1988, all systems were analyzed extensively to assure that hazards were identified, assessed and that the baseline risk was understood and appropriately communicated. Since the original RSRM baseline was established, Thiokol and NASA have implemented a number of initiatives that have further improved the RSRM. The robust design, completion of rigorous testing and flight success of the RSRM has resulted in a wise reluctance to make changes. One of the primary assessments required to accompany the documentation of each proposed change and aid in the decision making process is a risk assessment. Documentation supporting proposed changes, including the risk assessments from System Safety, are reviewed and assessed by Thiokol and NASA technical management. After thorough consideration, approved changes are implemented adding improvements to and reducing risk of the Space Shuttle RSRM.

Safety assessment of biotechnology-derived pharmaceuticals: ICH and beyond.

PubMed

Serabian, M A; Pilaro, A M

1999-01-01

Many scientific discussions, especially in the past 8 yr, have focused on definition of criteria for the optimal assessment of the preclinical toxicity of pharmaceuticals. With the current overlap of responsibility among centers within the Food and Drug Administration (FDA), uniformity of testing standards, when appropriate, would be desirable. These discussions have extended beyond the boundaries of the FDA and have culminated in the acceptance of formalized, internationally recognized guidances. The work of the International Committee on Harmonisation (ICH) and the initiatives developed by the FDA are important because they (a) represent a consensus scientific opinion, (b) promote consistency, (c) improve the quality of the studies performed, (d) assist the public sector in determining what may be generally acceptable to prepare product development plans, and (e) provide guidance for the sponsors in the design of preclinical toxicity studies. Disadvantages associated with such initiatives include (a) the establishment of a historical database that is difficult to relinquish, (b) the promotion of a check-the-box approach, i.e., a tendancy to perform only the minimum evaluation required by the guidelines, (c) the creation of a disincentive for industry to develop and validate new models, and (d) the creation of state-of-the-art guidances that may not allow for appropriate evaluation of novel therapies. The introduction of biotechnology-derived pharmaceuticals for clinical use has often required the application of unique approaches to assessing their safety in preclinical studies. There is much diversity among these products, which include the gene and cellular therapies, monoclonal antibodies, human-derived recombinant regulatory proteins, blood products, and vaccines. For many of the biological therapies, there will be unique product issues that may require specific modifications to protocol design and may raise additional safety concerns (e.g., immunogenicity

Integrating bioassays and analytical chemistry as an improved approach to support safety assessment of food contact materials.

PubMed

Veyrand, Julien; Marin-Kuan, Maricel; Bezencon, Claudine; Frank, Nancy; Guérin, Violaine; Koster, Sander; Latado, Hélia; Mollergues, Julie; Patin, Amaury; Piguet, Dominique; Serrant, Patrick; Varela, Jesus; Schilter, Benoît

2017-10-01

Food contact materials (FCM) contain chemicals which can migrate into food and result in human exposure. Although it is mandatory to ensure that migration does not endanger human health, there is still no consensus on how to pragmatically assess the safety of FCM since traditional approaches would require extensive toxicological and analytical testing which are expensive and time consuming. Recently, the combination of bioassays, analytical chemistry and risk assessment has been promoted as a new paradigm to identify toxicologically relevant molecules and address safety issues. However, there has been debate on the actual value of bioassays in that framework. In the present work, a FCM anticipated to release the endocrine active chemical 4-nonyphenol (4NP) was used as a model. In a migration study, the leaching of 4NP was confirmed by LC-MS/MS and GC-MS. This was correlated with an increase in both estrogenic and anti-androgenic activities as measured with bioassays. A standard risk assessment indicated that according to the food intake scenario applied, the level of 4NP measured was lower, close or slightly above the acceptable daily intake. Altogether these results show that bioassays could reveal the presence of an endocrine active chemical in a real-case FCM migration study. The levels reported were relevant for safety assessment. In addition, this work also highlighted that bioactivity measured in migrate does not necessarily represent a safety issue. In conclusion, together with analytics, bioassays contribute to identify toxicologically relevant molecules leaching from FCM and enable improved safety assessment.

Apparatus Notes.

ERIC Educational Resources Information Center

Eaton, Bruce G., Ed.

1980-01-01

Presents four notes that report new equipment and techniques of interest to physics teachers. These notes deal with collosions of atoms in solids, determining the viscosity of a liquid, measuring the speed of sound and demonstrating Doppler effect. (HM)

Development of Risk Assessment Matrix for NASA Engineering and Safety Center

NASA Technical Reports Server (NTRS)

Malone, Roy W., Jr.; Moses, Kelly

2004-01-01

This paper describes a study, which had as its principal goal the development of a sufficiently detailed 5 x 5 Risk Matrix Scorecard. The purpose of this scorecard is to outline the criteria by which technical issues can be qualitatively and initially prioritized. The tool using this score card has been proposed to be one of the information resources the NASA Engineering and Safety Center (NESC) takes into consideration when making decisions with respect to incoming information on safety concerns across the entire NASA agency. The contents of this paper discuss in detail each element of the risk matrix scorecard, definitions for those elements and the rationale behind the development of those definitions. This scorecard development was performed in parallel with the tailoring of the existing Futron Corporation Integrated Risk Management Application (IRMA) software tool. IRMA was tailored to fit NESC needs for evaluating incoming safety concerns and was renamed NESC Assessment Risk Management Application (NAFMA) which is still in developmental phase.

Approaches to the safety assessment of engineered nanomaterials (ENM) in food.

PubMed

Cockburn, Andrew; Bradford, Roberta; Buck, Neil; Constable, Anne; Edwards, Gareth; Haber, Bernd; Hepburn, Paul; Howlett, John; Kampers, Frans; Klein, Christoph; Radomski, Marek; Stamm, Hermann; Wijnhoven, Susan; Wildemann, Tanja

2012-06-01

A systematic, tiered approach to assess the safety of engineered nanomaterials (ENMs) in foods is presented. The ENM is first compared to its non-nano form counterpart to determine if ENM-specific assessment is required. Of highest concern from a toxicological perspective are ENMs which have potential for systemic translocation, are insoluble or only partially soluble over time or are particulate and bio-persistent. Where ENM-specific assessment is triggered, Tier 1 screening considers the potential for translocation across biological barriers, cytotoxicity, generation of reactive oxygen species, inflammatory response, genotoxicity and general toxicity. In silico and in vitro studies, together with a sub-acute repeat-dose rodent study, could be considered for this phase. Tier 2 hazard characterisation is based on a sentinel 90-day rodent study with an extended range of endpoints, additional parameters being investigated case-by-case. Physicochemical characterisation should be performed in a range of food and biological matrices. A default assumption of 100% bioavailability of the ENM provides a 'worst case' exposure scenario, which could be refined as additional data become available. The safety testing strategy is considered applicable to variations in ENM size within the nanoscale and to new generations of ENM. Copyright © 2012 Elsevier Ltd. All rights reserved.

Revising Lecture Notes: How Revision, Pauses, and Partners Affect Note Taking and Achievement

ERIC Educational Resources Information Center

Luo, Linlin; Kiewra, Kenneth A.; Samuelson, Lydia

2016-01-01

Note taking has been categorized as a two-stage process: the recording of notes and the review of notes. We contend that note taking might best involve a three-stage process where the missing stage is revision. This study investigated the benefits of revising lecture notes and addressed two questions: First, is revision more effective than…

Software Safety Risk in Legacy Safety-Critical Computer Systems

NASA Technical Reports Server (NTRS)

Hill, Janice; Baggs, Rhoda

2007-01-01

Safety-critical computer systems must be engineered to meet system and software safety requirements. For legacy safety-critical computer systems, software safety requirements may not have been formally specified during development. When process-oriented software safety requirements are levied on a legacy system after the fact, where software development artifacts don't exist or are incomplete, the question becomes 'how can this be done?' The risks associated with only meeting certain software safety requirements in a legacy safety-critical computer system must be addressed should such systems be selected as candidates for reuse. This paper proposes a method for ascertaining formally, a software safety risk assessment, that provides measurements for software safety for legacy systems which may or may not have a suite of software engineering documentation that is now normally required. It relies upon the NASA Software Safety Standard, risk assessment methods based upon the Taxonomy-Based Questionnaire, and the application of reverse engineering CASE tools to produce original design documents for legacy systems.

Heuristic evaluation of eNote: an electronic notes system.

PubMed

Bright, Tiffani J; Bakken, Suzanne; Johnson, Stephen B

2006-01-01

eNote is an electronic health record (EHR) system based on semi-structured narrative documents. A heuristic evaluation was conducted with a sample of five usability experts. eNote performed highly in: 1)consistency with standards and 2)recognition rather than recall. eNote needs improvement in: 1)help and documentation, 2)aesthetic and minimalist design, 3)error prevention, 4)helping users recognize, diagnosis, and recover from errors, and 5)flexibility and efficiency of use. The heuristic evaluation was an efficient method of evaluating our interface.

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.

Safety assessment in primary Mycobacterium tuberculosis smear microscopy centres in Blantyre Malawi: a facility based cross sectional survey.

PubMed

Majamanda, J; Ndhlovu, P; Shawa, I T

2013-12-01

Tuberculosis (TB) is caused by Mycobacterium tuberculosis and is transmitted mainly through aerosolization of infected sputum which puts laboratory workers at risk in spite of the laboratory workers' risk of infection being at 3 to 9 times higher than the general public. Laboratory safety should therefore be prioritized and optimized to provide sufficient safety to laboratory workers. To assess the safety for the laboratory workers in TB primary microscopy centres in Blantyre urban. TB primary microscopy centers in Blantyre urban were assessed in aspects of equipment availability, facility layout, and work practice, using a standardized WHO/AFRO ISO 15189 checklist for the developing countries which sets the minimum safety score at ≥80%. Each center was graded according to the score it earned upon assessment. Only one (1) microscopy center out nine (9) reached the minimum safety requirement. Four (4) centers were awarded 1 star level, four (4) centers were awarded 2 star level and only one (1) center was awarded 3 star level. In Blantyre urban, 89% of the Tuberculosis microscopy centers are failing to provide the minimum safety to the laboratory workers. Government and other stake holders should be committed in addressing the safety challenges of TB microscopy centres in the country to ensure safety for the laboratory workers. It is recommended that the study be conducted at the regional or national level for both public and private laboratories in order to have a general picture of safety in Tb microscopy centres possibly across the country.

The Safety of School Children in Arkansas. Special Report.

ERIC Educational Resources Information Center

Kelly, Paul D.

Noting that parents are very concerned about the safety of their children and the impact school violence has on their children's academic success, this report is intended to help parents and others understand how school safety is monitored in Arkansas. The report presents information on what students say about their access to weapons and…

The Effects of Safety Discrimination Training and Frequent Safety Observations on Safety-Related Behavior

ERIC Educational Resources Information Center

Taylor, Matthew A.; Alvero, Alicia M.

2012-01-01

The intent of the present study was to assess the effects of discrimination training only and in combination with frequent safety observations on five participants' safety-related behavior in a simulated office setting. The study used a multiple-baseline design across safety-related behaviors. Across all participants and behavior, safety improved…

CONTEXTUALIZED ASSESSMENT WITH BATTERED WOMEN: STRATEGIC SAFETY PLANNING TO COPE WITH MULTIPLE HARMS

PubMed Central

Lindhorst, Taryn; Nurius, Paula; Macy, Rebecca J.

2007-01-01

Given the prevalence of domestic violence and the likelihood that many victims will not receive services from specialized domestic violence providers, this article provides a framework for contextualized assessment that can be used by generalist practitioners. Drawing from stress and coping theory, the authors discuss the relevance of assessing appraisals and emotional responses within the context of environmental and individual risk and protective factors. Through an illustrative case assessment, the authors describe the contextualized assessment process and its ramifications for strategic safety planning. PMID:18167523

Probabilistic Causal Analysis for System Safety Risk Assessments in Commercial Air Transport

NASA Technical Reports Server (NTRS)

Luxhoj, James T.

2003-01-01

Aviation is one of the critical modes of our national transportation system. As such, it is essential that new technologies be continually developed to ensure that a safe mode of transportation becomes even safer in the future. The NASA Aviation Safety Program (AvSP) is managing the development of new technologies and interventions aimed at reducing the fatal aviation accident rate by a factor of 5 by year 2007 and by a factor of 10 by year 2022. A portfolio assessment is currently being conducted to determine the projected impact that the new technologies and/or interventions may have on reducing aviation safety system risk. This paper reports on advanced risk analytics that combine the use of a human error taxonomy, probabilistic Bayesian Belief Networks, and case-based scenarios to assess a relative risk intensity metric. A sample case is used for illustrative purposes.

Assessment of Food Safety Knowledge, Attitude, Self-Reported Practices, and Microbiological Hand Hygiene of Food Handlers

PubMed Central

Lee, Hui Key; Abdul Halim, Hishamuddin; Thong, Kwai Lin; Chai, Lay Ching

2017-01-01

Institutional foodborne illness outbreaks continue to hit the headlines in the country, indicating the failure of food handlers to adhere to safe practices during food preparation. Thus, this study aimed to compare the knowledge, attitude, and self-reported practices (KAP) of food safety assessment and microbiological assessment of food handlers’ hands as an indicator of hygiene practices in food premises. This study involved 85 food handlers working in a university located in Kuala Lumpur, Malaysia. The food safety KAP among food handlers (n = 67) was assessed using a questionnaire; while the hand swabs (n = 85) were tested for the total aerobic count, coliforms, and Escherichia coli, Staphylococcus aureus, Salmonella, Vibrio cholerae and Vibrio parahaemolyticus. The food handlers had moderate levels of food safety knowledge (61.7%) with good attitude (51.9/60) and self-reported practices (53.2/60). It is noteworthy that the good self-reported practices were not reflected in the microbiological assessment of food handlers’ hands, in which 65% of the food handlers examined had a total aerobic count ≥20 CFU/cm2 and Salmonella was detected on 48% of the food handlers’ hands. In conclusion, the suggestion of this study was that the food handlers had adequate food safety knowledge, but perceived knowledge failed to be translated into practices at work.

Modeling and Explaining Content: Definition, Research Support, and Measurement of the "ETS"® National Observational Teaching Examination (NOTE) Assessment Series. Research Memorandum No. RM-16-07

ERIC Educational Resources Information Center

Stickler, Leslie; Sykes, Gary

2016-01-01

This report reviews the scholarly and research evidence supporting the construct labeled modeling and explaining content (MEC), which is measured via a performance assessment in the "ETS"® National Observational Teaching Examination (NOTE) assessment series. This construct involves practices at the heart of teaching that deal with how…

Assessment of Food Safety Knowledge of High School and Transition Teachers of Special Needs Students

ERIC Educational Resources Information Center

Pivarnik, Lori F.; Patnoad, Martha S.; Richard, Nicole Leydon; Gable, Robert K.; Hirsch, Diane Wright; Madaus, Joseph; Scarpati, Stan; Carbone, Elena

2009-01-01

Adolescents with disabilities require access to general education and life skills instruction. Knowledge of food safety for this audience is important for health and valuable for work placement. The objective was to implement a survey to assess high school and transition special education teachers in RI, CT, and MA for food safety knowledge and…

A 3S Risk ?3SR? Assessment Approach for Nuclear Power: Safety Security and Safeguards.

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

Forrest, Robert; Reinhardt, Jason Christian; Wheeler, Timothy A.

Safety-focused risk analysis and assessment approaches struggle to adequately include malicious, deliberate acts against the nuclear power industry's fissile and waste material, infrastructure, and facilities. Further, existing methods do not adequately address non- proliferation issues. Treating safety, security, and safeguards concerns independently is inefficient because, at best, it may not take explicit advantage of measures that provide benefits against multiple risk domains, and, at worst, it may lead to implementations that increase overall risk due to incompatibilities. What is needed is an integrated safety, security and safeguards risk (or "3SR") framework for describing and assessing nuclear power risks that canmore » enable direct trade-offs and interactions in order to inform risk management processes -- a potential paradigm shift in risk analysis and management. These proceedings of the Sandia ePRA Workshop (held August 22-23, 2017) are an attempt to begin the discussions and deliberations to extend and augment safety focused risk assessment approaches to include security concerns and begin moving towards a 3S Risk approach. Safeguards concerns were not included in this initial workshop and are left to future efforts. This workshop focused on four themes in order to begin building out a the safety and security portions of the 3S Risk toolkit: 1. Historical Approaches and Tools 2. Current Challenges 3. Modern Approaches 4. Paths Forward and Next Steps This report is organized along the four areas described above, and concludes with a summary of key points. 2 Contact: rforres@sandia.gov; +1 (925) 294-2728« less

Evaluation of adverse events noted in children receiving continuous infusions of dexmedetomidine in the intensive care unit.

PubMed

Honey, Brooke L; Harrison, Donald L; Gormley, Andrew K; Johnson, Peter N

2010-01-01

Dexmedetomidine is an α(2)-adrenergic receptor agonist with sedative and analgesic effects in mechanically ventilated adults and children. Safety and efficacy data are limited in children. The purpose of this study is to retrospectively identify the incidence and types of adverse events noted in children receiving continuous infusions of dexmedetomidine and evaluate potential risk factors for adverse events. Between July 1, 2006, and July 31, 2007, data were collected on all children (< 18 years) who received continuous infusions of dexmedetomidine. Data collection included demographics, dexmedetomidine regimen, and type/number of adverse events. The primary endpoint was the total number of adverse events noted, including: transient hypertension, hypotension, neurological manifestations, apnea, and bradycardia. Secondary endpoints included categorization of each type of adverse event and an assessment of risk factors. A logistic regression model was used to assess the relationship of adverse events with independent variables including length of ICU stay, cumulative dose, peak infusion rate, duration of therapy, PRISM III score, and bolus dose. Thirty-six patients received dexmedetomidine representing 41 infusions. The median age was 16 months (range, 0.1-204 months) and median PRISM III score was 2 (range, 0-18). Eighteen (43.9%) patients received a bolus dose of dexmedetomidine. The median cumulative dose (mcg/kg) and peak dose (mcg/kg/hr) were 8.5 (range, 2.2-193.7) and 0.5 (range, 0.2-0.7), respectively. Dexmedetomidine was continued for a median of 20 (range, 3-263) hours. Six (14.6%) patients were slowly tapered off the continuous infusions. Twenty-one adverse events were noted in 17 patients, including 4 neurologic manifestations. Fourteen patients required interventions for adverse events. ICU length of stay was the only independent risk factor (p=0.036) for development of adverse events. Several potential adverse events were noted with dexmedetomidine

Safety Assessment for the Kozloduy National Disposal Facility in Bulgaria - 13507

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

Biurrun, E.; Haverkamp, B.; Lazaro, A.

2013-07-01

Due to the early decommissioning of four Water-Water Energy Reactors (WWER) 440-V230 reactors at the Nuclear Power Plant (NPP) near the city of Kozloduy in Bulgaria, large amounts of low and intermediate radioactive waste will arise much earlier than initially scheduled. In or-der to manage the radioactive waste from the early decommissioning, Bulgaria has intensified its efforts to provide a near surface disposal facility at Radiana with the required capacity. To this end, a project was launched and assigned in international competition to a German-Spanish consortium to provide the complete technical planning including the preparation of the Intermediate Safety Assessmentmore » Report. Preliminary results of operational and long-term safety show compliance with the Bulgarian regulatory requirements. The long-term calculations carried out for the Radiana site are also a good example of how analysis of safety assessment results can be used for iterative improvements of the assessment by pointing out uncertainties and areas of future investigations to reduce such uncertainties in regard to the potential radiological impact. The computer model used to estimate the long-term evolution of the future repository at Radiana predicted a maximum total annual dose for members of the critical group, which is carried to approximately 80 % by C-14 for a specific ingestion pathway. Based on this result and the outcome of the sensitivity analysis, existing uncertainties were evaluated and areas for reasonable future investigations to reduce these uncertainties were identified. (authors)« less

Safety and risk assessment of ceramide 3 in cosmetic products.

PubMed

Choi, Seul Min; Lee, Byung-Mu

2015-10-01

Ceramide 3 is used mainly as a moisturizer in various cosmetic products. Although several safety studies on formulations containing pseudo-ceramide or ceramide have been conducted at the preclinical and clinical levels for regulatory approval, no studies have evaluated the systemic toxicity of ceramide 3. To address this issue, we conducted a risk assessment and comprehensive toxicological review of ceramide and pseudo-ceramide. We assumed that ceramide 3 is present in various personal and cosmetic products at concentrations of 0.5-10%. Based on previously reported exposure data, the margin of safety (MOS) was calculated for product type, use pattern, and ceramide 3 concentration. Lipsticks with up to 10% ceramide 3 (MOS = 4111) are considered safe, while shampoos containing 0.5% ceramide 3 (MOS = 148) are known to be safe. Reported MOS values for body lotion applied to the hands (1% ceramide 3) and back (5% ceramide 3) were 103 and 168, respectively. We anticipate that face cream would be safe up to a ceramide 3 concentration of 3% (MOS = 149). Collectively, the MOS approach indicated no safety concerns for cosmetic products containing less than 1% ceramide 3. Copyright © 2015 Elsevier Ltd. All rights reserved.

Assessing the general safety and tolerability of vildagliptin: value of pooled analyses from a large safety database versus evaluation of individual studies

PubMed Central

Schweizer, Anja; Dejager, Sylvie; Foley, James E; Kothny, Wolfgang

2011-01-01

Aim: Analyzing safety aspects of a drug from individual studies can lead to difficult-to-interpret results. The aim of this paper is therefore to assess the general safety and tolerability, including incidences of the most common adverse events (AEs), of vildagliptin based on a large pooled database of Phase II and III clinical trials. Methods: Safety data were pooled from 38 studies of ≥12 to ≥104 weeks’ duration. AE profiles of vildagliptin (50 mg bid; N = 6116) were evaluated relative to a pool of comparators (placebo and active comparators; N = 6210). Absolute incidence rates were calculated for all AEs, serious AEs (SAEs), discontinuations due to AEs, and deaths. Results: Overall AEs, SAEs, discontinuations due to AEs, and deaths were all reported with a similar frequency in patients receiving vildagliptin (69.1%, 8.9%, 5.7%, and 0.4%, respectively) and patients receiving comparators (69.0%, 9.0%, 6.4%, and 0.4%, respectively), whereas drug-related AEs were seen with a lower frequency in vildagliptin-treated patients (15.7% vs 21.7% with comparators). The incidences of the most commonly reported specific AEs were also similar between vildagliptin and comparators, except for increased incidences of hypoglycemia, tremor, and hyperhidrosis in the comparator group related to the use of sulfonylureas. Conclusions: The present pooled analysis shows that vildagliptin was overall well tolerated in clinical trials of up to >2 years in duration. The data further emphasize the value of a pooled analysis from a large safety database versus assessing safety and tolerability from individual studies. PMID:21415917

A safety culture assessment by mixed methods at a public maternity and infant hospital in China

PubMed Central

Listyowardojo, Tita Alissa; Yan, Xiaoling; Leyshon, Stephen; Ray-Sannerud, Bobbie; Yu, Xin Yan; Zheng, Kai; Duan, Tao

2017-01-01

Objective To assess safety culture at a public maternity hospital in Shanghai, China, using a sequential mixed methods approach. The study was part of a bigger study looking at the application of the mixed methods approach to assess safety culture in health care in different organizations and countries. Methodology A mixed methods approach was utilized by first distributing the Safety Attitudes Questionnaire measuring six safety culture dimensions and five independent items to all hospital staff (n=1482) working in 18 departments at a single hospital. Afterward, semistructured interviews were conducted using convenience sampling, where 48 hospital staff from nine departments at the same hospital were individually interviewed. Results The survey received a response rate of 96%. The survey findings show significant differences between the hospital departments in almost all safety culture dimensions and independent items. Similarly, the interview findings revealed that there were different, competing priorities between departments perceived to result in a reduced quality of collaboration and bottlenecks in care delivery. Another major finding was that staff who worked more hours per week would perceive working conditions significantly more negatively. Issues related to working conditions were also the most common concerns discussed in the interviews, especially the issue on high workload. High workload was also reflected in the fact that 91.45% of survey respondents reported that they worked 40 hours or longer per week. Finally, interview findings complemented survey findings, thus providing a more complete and accurate picture of safety culture. Conclusion Hospital leaders need to prioritize interventions focused on improving the quality of cross-department collaboration and reducing workload. A mixed methods assessment of safety culture provides more meaningful, targeted results, enabling leaders to prioritize and tailor improvement efforts to increase the impact of

Staying silent about safety issues: Conceptualizing and measuring safety silence motives.

PubMed

Manapragada, Archana; Bruk-Lee, Valentina

2016-06-01

Communication between employees and supervisors about safety-related issues is an important component of a safe workplace. When supervisors receive information from employees about safety issues, they may gain otherwise-missed opportunities to correct these issues and/or prevent negative safety outcomes. A series of three studies were conducted to identify various safety silence motives, which describe the reasons that employees do not speak up to supervisors about safety-related issues witnessed in the workplace, and to develop a tool to assess these motives. Results suggest that employees stay silent about safety issues based on perceptions of altering relationships with others (relationship-based), perceptions of the organizational climate (climate-based), the assessment of the safety issue (issue-based), or characteristics of the job (job-based). We developed a 17-item measure to assess these four motives, and initial evidence was found for the construct and incremental validity of the safety silence motives measure in a sample of nurses. Copyright © 2016 Elsevier Ltd. All rights reserved.

Practice-based evidence: profiling the safety of cilostazol by text-mining of clinical notes.

PubMed

Leeper, Nicholas J; Bauer-Mehren, Anna; Iyer, Srinivasan V; Lependu, Paea; Olson, Cliff; Shah, Nigam H

2013-01-01

Peripheral arterial disease (PAD) is a growing problem with few available therapies. Cilostazol is the only FDA-approved medication with a class I indication for intermittent claudication, but carries a black box warning due to concerns for increased cardiovascular mortality. To assess the validity of this black box warning, we employed a novel text-analytics pipeline to quantify the adverse events associated with Cilostazol use in a clinical setting, including patients with congestive heart failure (CHF). We analyzed the electronic medical records of 1.8 million subjects from the Stanford clinical data warehouse spanning 18 years using a novel text-mining/statistical analytics pipeline. We identified 232 PAD patients taking Cilostazol and created a control group of 1,160 PAD patients not taking this drug using 1:5 propensity-score matching. Over a mean follow up of 4.2 years, we observed no association between Cilostazol use and any major adverse cardiovascular event including stroke (OR = 1.13, CI [0.82, 1.55]), myocardial infarction (OR = 1.00, CI [0.71, 1.39]), or death (OR = 0.86, CI [0.63, 1.18]). Cilostazol was not associated with an increase in any arrhythmic complication. We also identified a subset of CHF patients who were prescribed Cilostazol despite its black box warning, and found that it did not increase mortality in this high-risk group of patients. This proof of principle study shows the potential of text-analytics to mine clinical data warehouses to uncover 'natural experiments' such as the use of Cilostazol in CHF patients. We envision this method will have broad applications for examining difficult to test clinical hypotheses and to aid in post-marketing drug safety surveillance. Moreover, our observations argue for a prospective study to examine the validity of a drug safety warning that may be unnecessarily limiting the use of an efficacious therapy.

Eye Protection: Safety Glasses. Safety Spotlight

ERIC Educational Resources Information Center

Deck, Anita; Roy, Ken

2017-01-01

When it comes to eye safety, there are some situations in which regular safety glasses will work adequately for the needs of the STEM education classroom or laboratory. However, there are certain instances in which safety goggles must be used for safer protection. Taking the time to analyze hazards and assess the risks prior to any activity in the…

Pattern Notes.

ERIC Educational Resources Information Center

Fields, Alan

1980-01-01

Looks at an alternative method to linear notes for organizing thoughts when preparing a talk or paper. This method displays the manner in which the relationships of a subject are organized and offers a format for displaying complex inter-dependencies in place of linear notes. (Author/MER)

2008 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

Lamoreaux, Richard W.

2008-01-01

Welcome to the 2008 edition of the NASA Range Safety Annual Report. Funded by NASA Headquarters, this report provides a NASA Range Safety overview for current and potential range users. This year, along with full length articles concerning various subject areas, we have provided updates to standard subjects with links back to the 2007 original article. Additionally, we present summaries from the various NASA Range Safety Program activities that took place throughout the year, as well as information on several special projects that may have a profound impact on the way we will do business in the future. The sections include a program overview and 2008 highlights of Range Safety Training; Range Safety Policy; Independent Assessments and Common Risk Analysis Tools Development; Support to Program Operations at all ranges conducting NASA launch operations; a continuing overview of emerging Range Safety-related technologies; Special Interests Items that include recent changes in the ELV Payload Safety Program and the VAS explosive siting study; and status reports from all of the NASA Centers that have Range Safety responsibilities. As is the case each year, contributors to this report are too numerous to mention, but we thank individuals from the NASA Centers, the Department of Defense, and civilian organizations for their contributions. We have made a great effort to include the most current information available. We recommend that this report be used only for guidance and that the validity and accuracy of all articles be verified for updates. This is the third year we have utilized this web-based format for the annual report. We continually receive positive feedback on the web-based edition, and we hope you enjoy this year's product as well. It has been a very busy and productive year on many fronts as you will note as you review this report. Thank you to everyone who contributed to make this year a successful one, and I look forward to working with all of you in the

Why risk is not variance: an expository note.

PubMed

Cox, Louis Anthony Tony

2008-08-01

Variance (or standard deviation) of return is widely used as a measure of risk in financial investment risk analysis applications, where mean-variance analysis is applied to calculate efficient frontiers and undominated portfolios. Why, then, do health, safety, and environmental (HS&E) and reliability engineering risk analysts insist on defining risk more flexibly, as being determined by probabilities and consequences, rather than simply by variances? This note suggests an answer by providing a simple proof that mean-variance decision making violates the principle that a rational decisionmaker should prefer higher to lower probabilities of receiving a fixed gain, all else being equal. Indeed, simply hypothesizing a continuous increasing indifference curve for mean-variance combinations at the origin is enough to imply that a decisionmaker must find unacceptable some prospects that offer a positive probability of gain and zero probability of loss. Unlike some previous analyses of limitations of variance as a risk metric, this expository note uses only simple mathematics and does not require the additional framework of von Neumann Morgenstern utility theory.

A note on notes: note taking and containment.

PubMed

Levine, Howard B

2007-07-01

In extreme situations of massive projective identification, both the analyst and the patient may come to share a fantasy or belief that his or her own psychic reality will be annihilated if the psychic reality of the other is accepted or adopted (Britton 1998). In the example of' Dr. M and his patient, the paradoxical dilemma around note taking had highly specific transference meanings; it was not simply an instance of the generalized human response of distracted attention that Freud (1912) had spoken of, nor was it the destabilization of analytic functioning that I tried to describe in my work with Mr. L. Whether such meanings will always exist in these situations remains a matter to be determined by further clinical experience. In reopening a dialogue about note taking during sessions, I have attempted to move the discussion away from categorical injunctions about what analysis should or should not do, and instead to foster a more nuanced, dynamic, and pair-specific consideration of the analyst's functioning in the immediate context of the analytic relationship. There is, of course, a wide variety of listening styles among analysts, and each analyst's mental functioning may be affected differently by each patient whom the analyst sees. I have raised many questions in the hopes of stimulating an expanded discussion that will allow us to share our experiences and perhaps reach additional conclusions. Further consideration may lead us to decide whether note taking may have very different meanings for other analysts and analyst-patient pairs, and whether it may serve useful functions in addition to the one that I have described.

Predicate Argument Structure Frames for Modeling Information in Operative Notes

PubMed Central

Wang, Yan; Pakhomov, Serguei; Melton, Genevieve B.

2015-01-01

The rich information about surgical procedures contained in operative notes is a valuable data source for improving the clinical evidence base and clinical research. In this study, we propose a set of Predicate Argument Structure (PAS) frames for surgical action verbs to assist in the creation of an information extraction (IE) system to automatically extract details about the techniques, equipment, and operative steps from operative notes. We created PropBank style PAS frames for the 30 top surgical action verbs based on examination of randomly selected sample sentences from 3,000 Laparoscopic Cholecystectomy notes. To assess completeness of the PAS frames to represent usage of same action verbs, we evaluated the PAS frames created on sample sentences from operative notes of 6 other gastrointestinal surgical procedures. Our results showed that the PAS frames created with one type of surgery can successfully denote the usage of the same verbs in operative notes of broader surgical categories. PMID:23920664

Safety assessment characteristics of pedestrian legform impactors in vehicle-front impact tests.

PubMed

Matsui, Yasuhiro

2014-12-01

This study investigated the characteristics of safety assessment results of front-area vehicle impact tests carried out using the Transport Research Laboratory (TRL) legform impactor and a flexible legform impactor (FLEX legform impactor). Different types of vehicles (sedan, sport utility vehicle, high-roof K-car, and light cargo van) were examined. The impact locations in the study were the center of the bumper and an extremely stiff structure of the bumper (i.e., in front of the side member) of each tested vehicle. The measured injury criteria were normalized by injury assessment reference values of each legform impactor. The test results for center and side-member impacts indicated that there were no significant differences in ligament injury assessments derived from the normalized knee ligament injury measures between the TRL legform impactor and the FLEX legform impactor. Evaluations made using the TRL legform impactor and the FLEX legform impactor are thus similar in the vehicle safety investigation for knee ligament injury. Vehicle-center impact test results revealed that the tibia fracture assessments derived from the normalized tibia fracture measures did not significantly differ between the TRL legform impactor and the FLEX legform impactor. However, for an impact against an extremely stiff structure, there was a difference in the tibia fracture assessment between the FLEX legform impactor and the TRL legform impactor owing to their different sensor types. Copyright © 2014 Elsevier Ltd. All rights reserved.

Development, Dissemination, and Assessment of a Food Safety Systems Management Curriculum for Agribusiness Students in Armenia

ERIC Educational Resources Information Center

Pokharel, Siroj; Marcy, Joseph E.; Neilan, Angela M.; Cutter, Catherine N.

2017-01-01

This study addresses the development, dissemination, and assessment of a Food Safety System Management (FSSM) curriculum offered to college-aged, agribusiness students in Yerevan, Armenia. Prior to beginning the program, demographic data were collected and a paper-based pretest was administered to access the food safety knowledge, behavior, and…

Student Threat Assessment as a Standard School Safety Practice: Results from a Statewide Implementation Study

ERIC Educational Resources Information Center

Cornell, Dewey; Maeng, Jennifer L.; Burnette, Anna Grace; Jia, Yuane; Huang, Francis; Konold, Timothy; Datta, Pooja; Malone, Marisa; Meyer, Patrick

2018-01-01

Threat assessment has been widely endorsed as a school safety practice, but there is little research on its implementation. In 2013, Virginia became the first state to mandate student threat assessment in its public schools. The purpose of this study was to examine the statewide implementation of threat assessment and to identify how threat…

Population perception of surgical safety and body image trauma: a plea for scarless surgery?

PubMed

Bucher, Pascal; Pugin, François; Ostermann, Sandrine; Ris, Frederic; Chilcott, Michael; Morel, Philippe

2011-02-01

Laparoendoscopic single-site surgery (LESS) and natural orifice translumenal endoscopic surgery (NOTES) are prospected as the future of minimally invasive surgery. While scarless surgery (NOTES and LESS) is gaining increasing popularity, perception of these approaches should be investigated. An anonymous questionnaire describing laparoscopy, LESS, and NOTES was given to medical staff (n=120), paramedical staff (n=100), surgical patients (n=100), and the general population (n=100). The survey participants (median age, 37 years; range, 18-81 years) were queried about their expectations for surgical treatment and their approach preference. The first concern of the survey responders was the risk of surgical complications (92%). When asked about the respective importance of surgical safety, cure, and cosmetics, cure was placed first by 74%, safety by 33%, and cosmetics by 3%. These results were not influenced by sex, age, prior surgery or endoscopy, or education. When operative risk was similar, 90% of the participants preferred a scarless approach (75% preferred LESS and 15% preferred NOTES) to laparoscopy. The scarless approach preference was significantly higher among the younger participants (age<40 years; p=0.026), whereas sex showed no influence. The LESS preference was significantly higher among patients and the general population (86%) than among medical (67%) and paramedical (70%) staffs (p<0.001). A decreasing trend of preference for LESS and NOTES was observed with increased procedural risks. Although cure and safety remain the main concern, the population has a favorable perception of scarless surgery, even in the case of increased procedural risk, with LESS favored over NOTES. Such a popular adoption of scarless surgery should warrant the promotion of further research, technological innovations, and the establishment of surgeon training to improve its safety.

Microbiological performance of a food safety management system in a food service operation.

PubMed

Lahou, E; Jacxsens, L; Daelman, J; Van Landeghem, F; Uyttendaele, M

2012-04-01

The microbiological performance of a food safety management system in a food service operation was measured using a microbiological assessment scheme as a vertical sampling plan throughout the production process, from raw materials to final product. The assessment scheme can give insight into the microbiological contamination and the variability of a production process and pinpoint bottlenecks in the food safety management system. Three production processes were evaluated: a high-risk sandwich production process (involving raw meat preparation), a medium-risk hot meal production process (starting from undercooked raw materials), and a low-risk hot meal production process (reheating in a bag). Microbial quality parameters, hygiene indicators, and relevant pathogens (Listeria monocytogenes, Salmonella, Bacillus cereus, and Escherichia coli O157) were in accordance with legal criteria and/or microbiological guidelines, suggesting that the food safety management system was effective. High levels of total aerobic bacteria (>3.9 log CFU/50 cm(2)) were noted occasionally on gloves of food handlers and on food contact surfaces, especially in high contamination areas (e.g., during handling of raw material, preparation room). Core control activities such as hand hygiene of personnel and cleaning and disinfection (especially in highly contaminated areas) were considered points of attention. The present sampling plan was used to produce an overall microbiological profile (snapshot) to validate the food safety management system in place.

Ascending-dose study of noribogaine in healthy volunteers: pharmacokinetics, pharmacodynamics, safety, and tolerability.

PubMed

Glue, Paul; Lockhart, Michelle; Lam, Fred; Hung, Noelyn; Hung, Cheung-Tak; Friedhoff, Lawrence

2015-02-01

Noribogaine is the active metabolite of the naturally occurring psychoactive substance ibogaine, and may help suppress withdrawal symptoms in opioid-dependent subjects. The objectives of this Phase I study were to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of noribogaine. In this ascending single-dose, placebo-controlled, randomized, double-blind, parallel-group study in 36 healthy drug-free male volunteers, 4 cohorts (n = 9) received oral doses of 3, 10, 30, or 60 mg or matching placebo, with intensive safety and pharmacokinetic assessments out to 216 hours, along with pharmacodynamic assessments sensitive to the effects of mu-opioid agonists. Noribogaine was rapidly absorbed, with peak concentrations occurring 2-3 hours after oral dosing, and showed dose-linear increases of area under the concentration-time curve (AUC) and Cmax between 3 and 60 mg. The drug was slowly eliminated, with mean half-life estimates of 28-49 hours across dose groups. Apparent volume of distribution was high (mean 1417-3086 L across dose groups). No safety or tolerability issues were identified in any cohort. No mu-opioid agonist pharmacodynamic effects were noted in pupillometry or cold-pressor testing. Single oral doses of noribogaine 3-60 mg were safe and well tolerated in healthy volunteers. © 2014, The American College of Clinical Pharmacology.

29 CFR Appendix A to Subpart P of... - Model Fire Safety Plan (Non-Mandatory)

Code of Federal Regulations, 2013 CFR

2013-07-01

... 29 Labor 7 2013-07-01 2013-07-01 false Model Fire Safety Plan (Non-Mandatory) A Appendix A to...—Model Fire Safety Plan (Non-Mandatory) Model Fire Safety Plan Note: This appendix is non-mandatory and provides guidance to assist employers in establishing a Fire Safety Plan as required in § 1915.502. Table...

29 CFR Appendix A to Subpart P to... - Model Fire Safety Plan (Non-Mandatory)

Code of Federal Regulations, 2012 CFR

2012-07-01

... 29 Labor 7 2012-07-01 2012-07-01 false Model Fire Safety Plan (Non-Mandatory) A Appendix A to...—Model Fire Safety Plan (Non-Mandatory) Model Fire Safety Plan Note: This appendix is non-mandatory and provides guidance to assist employers in establishing a Fire Safety Plan as required in § 1915.502. Table...

29 CFR Appendix A to Subpart P of... - Model Fire Safety Plan (Non-Mandatory)

Code of Federal Regulations, 2014 CFR

2014-07-01

... 29 Labor 7 2014-07-01 2014-07-01 false Model Fire Safety Plan (Non-Mandatory) A Appendix A to...—Model Fire Safety Plan (Non-Mandatory) Model Fire Safety Plan Note: This appendix is non-mandatory and provides guidance to assist employers in establishing a Fire Safety Plan as required in § 1915.502. Table...

Integrating Safety Assessment Methods using the Risk Informed Safety Margins Characterization (RISMC) Approach

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

Curtis Smith; Diego Mandelli

Safety is central to the design, licensing, operation, and economics of nuclear power plants (NPPs). As the current light water reactor (LWR) NPPs age beyond 60 years, there are possibilities for increased frequency of systems, structures, and components (SSC) degradations or failures that initiate safety significant events, reduce existing accident mitigation capabilities, or create new failure modes. Plant designers commonly “over-design” portions of NPPs and provide robustness in the form of redundant and diverse engineered safety features to ensure that, even in the case of well-beyond design basis scenarios, public health and safety will be protected with a very highmore » degree of assurance. This form of defense-in-depth is a reasoned response to uncertainties and is often referred to generically as “safety margin.” Historically, specific safety margin provisions have been formulated primarily based on engineering judgment backed by a set of conservative engineering calculations. The ability to better characterize and quantify safety margin is important to improved decision making about LWR design, operation, and plant life extension. A systematic approach to characterization of safety margins and the subsequent margin management options represents a vital input to the licensee and regulatory analysis and decision making that will be involved. In addition, as research and development (R&D) in the LWR Sustainability (LWRS) Program and other collaborative efforts yield new data, sensors, and improved scientific understanding of physical processes that govern the aging and degradation of plant SSCs needs and opportunities to better optimize plant safety and performance will become known. To support decision making related to economics, readability, and safety, the RISMC Pathway provides methods and tools that enable mitigation options known as margins management strategies. The purpose of the RISMC Pathway R&D is to support plant decisions for risk

The SEURAT-1 approach towards animal free human safety assessment.

PubMed

Gocht, Tilman; Berggren, Elisabet; Ahr, Hans Jürgen; Cotgreave, Ian; Cronin, Mark T D; Daston, George; Hardy, Barry; Heinzle, Elmar; Hescheler, Jürgen; Knight, Derek J; Mahony, Catherine; Peschanski, Marc; Schwarz, Michael; Thomas, Russell S; Verfaillie, Catherine; White, Andrew; Whelan, Maurice

2015-01-01

SEURAT-1 is a European public-private research consortium that is working towards animal-free testing of chemical compounds and the highest level of consumer protection. A research strategy was formulated based on the guiding principle to adopt a toxicological mode-of-action framework to describe how any substance may adversely affect human health.The proof of the initiative will be in demonstrating the applicability of the concepts on which SEURAT-1 is built on three levels:(i) Theoretical prototypes for adverse outcome pathways are formulated based on knowledge already available in the scientific literature on investigating the toxicological mode-of-actions leading to adverse outcomes (addressing mainly liver toxicity);(ii)adverse outcome pathway descriptions are used as a guide for the formulation of case studies to further elucidate the theoretical model and to develop integrated testing strategies for the prediction of certain toxicological effects (i.e., those related to the adverse outcome pathway descriptions);(iii) further case studies target the application of knowledge gained within SEURAT-1 in the context of safety assessment. The ultimate goal would be to perform ab initio predictions based on a complete understanding of toxicological mechanisms. In the near-term, it is more realistic that data from innovative testing methods will support read-across arguments. Both scenarios are addressed with case studies for improved safety assessment. A conceptual framework for a rational integrated assessment strategy emerged from designing the case studies and is discussed in the context of international developments focusing on alternative approaches for evaluating chemicals using the new 21st century tools for toxicity testing.

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.

Department of the Navy Explosives Safety Site Approval Process Improvement Initiative

DTIC Science & Technology

2010-07-01

All applicable existing land-use restrictions, such as explosives safety quantity distance (ESQD) arcs, Hazards of Electromagnetic Radiation to... Ordnance ( HERO ) zones, air field safety zones, and munitions response program sites are noted in the ESAR.  PWO will have in place a written...N547) Naval Ordnance Safety and Security Activity Farragut Hall, 3817 Strauss Ave, Suite 108 Indian Head, MD 20640-5151 (301) 744-6059

Redundancy-Aware Topic Modeling for Patient Record Notes

PubMed Central

Cohen, Raphael; Aviram, Iddo; Elhadad, Michael; Elhadad, Noémie

2014-01-01

The clinical notes in a given patient record contain much redundancy, in large part due to clinicians’ documentation habit of copying from previous notes in the record and pasting into a new note. Previous work has shown that this redundancy has a negative impact on the quality of text mining and topic modeling in particular. In this paper we describe a novel variant of Latent Dirichlet Allocation (LDA) topic modeling, Red-LDA, which takes into account the inherent redundancy of patient records when modeling content of clinical notes. To assess the value of Red-LDA, we experiment with three baselines and our novel redundancy-aware topic modeling method: given a large collection of patient records, (i) apply vanilla LDA to all documents in all input records; (ii) identify and remove all redundancy by chosing a single representative document for each record as input to LDA; (iii) identify and remove all redundant paragraphs in each record, leaving partial, non-redundant documents as input to LDA; and (iv) apply Red-LDA to all documents in all input records. Both quantitative evaluation carried out through log-likelihood on held-out data and topic coherence of produced topics and qualitative assessement of topics carried out by physicians show that Red-LDA produces superior models to all three baseline strategies. This research contributes to the emerging field of understanding the characteristics of the electronic health record and how to account for them in the framework of data mining. The code for the two redundancy-elimination baselines and Red-LDA is made publicly available to the community. PMID:24551060

Redundancy-aware topic modeling for patient record notes.

PubMed

Cohen, Raphael; Aviram, Iddo; Elhadad, Michael; Elhadad, Noémie

2014-01-01

The clinical notes in a given patient record contain much redundancy, in large part due to clinicians' documentation habit of copying from previous notes in the record and pasting into a new note. Previous work has shown that this redundancy has a negative impact on the quality of text mining and topic modeling in particular. In this paper we describe a novel variant of Latent Dirichlet Allocation (LDA) topic modeling, Red-LDA, which takes into account the inherent redundancy of patient records when modeling content of clinical notes. To assess the value of Red-LDA, we experiment with three baselines and our novel redundancy-aware topic modeling method: given a large collection of patient records, (i) apply vanilla LDA to all documents in all input records; (ii) identify and remove all redundancy by chosing a single representative document for each record as input to LDA; (iii) identify and remove all redundant paragraphs in each record, leaving partial, non-redundant documents as input to LDA; and (iv) apply Red-LDA to all documents in all input records. Both quantitative evaluation carried out through log-likelihood on held-out data and topic coherence of produced topics and qualitative assessment of topics carried out by physicians show that Red-LDA produces superior models to all three baseline strategies. This research contributes to the emerging field of understanding the characteristics of the electronic health record and how to account for them in the framework of data mining. The code for the two redundancy-elimination baselines and Red-LDA is made publicly available to the community.

Safety culture perceptions of pharmacists in Malaysian hospitals and health clinics: a multicentre assessment using the Safety Attitudes Questionnaire

PubMed Central

Samsuri, Srima Elina; Pei Lin, Lua; Fahrni, Mathumalar Loganathan

2015-01-01

Objective To assess the safety attitudes of pharmacists, provide a profile of their domains of safety attitude and correlate their attitudes with self-reported rates of medication errors. Design A cross-sectional study utilising the Safety Attitudes Questionnaire (SAQ). Setting 3 public hospitals and 27 health clinics. Participants 117 pharmacists. Main outcome measure(s) Safety culture mean scores, variation in scores across working units and between hospitals versus health clinics, predictors of safety culture, and medication errors and their correlation. Results Response rate was 83.6% (117 valid questionnaires returned). Stress recognition (73.0±20.4) and working condition (54.8±17.4) received the highest and lowest mean scores, respectively. Pharmacists exhibited positive attitudes towards: stress recognition (58.1%), job satisfaction (46.2%), teamwork climate (38.5%), safety climate (33.3%), perception of management (29.9%) and working condition (15.4%). With the exception of stress recognition, those who worked in health clinics scored higher than those in hospitals (p<0.05) and higher scores (overall score as well as score for each domain except for stress recognition) correlated negatively with reported number of medication errors. Conversely, those working in hospital (versus health clinic) were 8.9 times more likely (p<0.01) to report a medication error (OR 8.9, CI 3.08 to 25.7). As stress recognition increased, the number of medication errors reported increased (p=0.023). Years of work experience (p=0.017) influenced the number of medication errors reported. For every additional year of work experience, pharmacists were 0.87 times less likely to report a medication error (OR 0.87, CI 0.78 to 0.98). Conclusions A minority (20.5%) of the pharmacists working in hospitals and health clinics was in agreement with the overall SAQ questions and scales. Pharmacists in outpatient and ambulatory units and those in health clinics had better perceptions of safety

Vaccine safety evaluation: Practical aspects in assessing benefits and risks.

PubMed

Di Pasquale, Alberta; Bonanni, Paolo; Garçon, Nathalie; Stanberry, Lawrence R; El-Hodhod, Mostafa; Tavares Da Silva, Fernanda

2016-12-20

Vaccines are different from most medicines in that they are administered to large and mostly healthy populations including infants and children, so there is a low tolerance for potential risks or side-effects. In addition, the long-term benefits of immunisation in reducing or eliminating infectious diseases may induce complacency due to the absence of cases. However, as demonstrated in recent measles outbreaks in Europe and United States, reappearance of the disease occurs as soon as vaccine coverage falls. Unfounded vaccine scares such as those associating the combined measles-mumps-rubella vaccine with autism, and whole-cell pertussis vaccines with encephalopathy, can also have massive impacts, resulting in reduced vaccine uptake and disease resurgence. The safety assessment of vaccines is exhaustive and continuous; beginning with non-clinical evaluation of their individual components in terms of purity, stability and sterility, continuing throughout the clinical development phase and entire duration of use of the vaccine; including post-approval. The breadth and depth of safety assessments conducted at multiple levels by a range of independent organizations increases confidence in the rigour with which any potential risks or side-effects are investigated and managed. Industry, regulatory agencies, academia, the medical community and the general public all play a role in monitoring vaccine safety. Within these stakeholder groups, the healthcare professional and vaccine provider have key roles in the prevention, identification, investigation and management of adverse events following immunisation (AEFI). Guidelines and algorithms aid in determining whether AEFI may have been caused by the vaccine, or whether it is coincidental to it. Healthcare providers are encouraged to rigorously investigate AEFIs and to report them via local reporting processes. The ultimate objective for all parties is to ensure vaccines have a favourable benefit-risk profile. Copyright �

Chemistry, manufacturing and exposure assessments to support generally recognized as safe (GRAS) determinations.

PubMed

Barraj, Leila; Murphy, Mary; Tran, Nga; Petersen, Barbara

2016-08-01

Identity, stability, purity, intended use levels in what foods and technical effects, and probable intake are among the key components in an assessment to support GRAS determinations. The specifications of identity of a food substance are an important component of the safety assessment as changes in the physical and chemical properties of a food substance can influence its technical effect in food and can influence its nutritional or toxicological properties of the food substance. Estimating exposure is a key determining step in the safety evaluation of a food substance. Intake assessment in GRAS determination is necessarily comprehensive based on cumulative exposure, i.e. proposed new uses plus background dietary exposure. Intake estimates for safety assurance in a GRAS determination also represent conservative overestimate of chronic exposure as they are based on 2-day average daily intake and the upper percentile (90th) intake among consumers. In contrast, in a nutrient assessment where realistic intake estimates are of interest, usual intake estimates are relied upon. It should also be noted that intake estimates for GRAS determinations are also more conservative than estimate of dietary exposure by EPA (FIFRA), where mean per capita are used to assess chronic exposure. Overall, for safety assurance, intake assessments in GRAS determinations are comprehensively cumulative and typically conservative overestimate of exposures. Copyright © 2016. Published by Elsevier Inc.

Determining an appropriate integrated assessment model of tourism safety risk within the Changbai Mountain Scenic Area

NASA Astrophysics Data System (ADS)

Zhou, Lijun; Liu, Jisheng

2017-03-01

Tourism safety is gradually gaining more attention due to the rapid development of the tourism industry in China. Changbai Mountain is one of the most famous mountainous scenic areas in Northeast Asia. Assessment on Changbai Mountain scenic area’s tourism safety risk could do a favor in detecting influence factor of tourism safety risk and classifying tourism safety risk rank, thereby reducing and preventing associated tourism safety risks. This paper uses the Changbai Mountain scenic area as the study subject. By the means of experts scoring and analytic hierarchy process on quantified relevant evaluation indicator, the grid GIS method is used to vectorize the relevant data within a 1000m grid. It respectively analyzes main indicators associated tourism safety risk in Changbai Mountain scenic area, including hazard, exposure, vulnerability and ability to prevent and mitigate disasters. The integrated tourism safety risk model is used to comprehensively evaluate tourism safety risk in Changbai Mountain scenic area.

A fuzzy model for assessing risk of occupational safety in the processing industry.

PubMed

Tadic, Danijela; Djapan, Marko; Misita, Mirjana; Stefanovic, Miladin; Milanovic, Dragan D

2012-01-01

Managing occupational safety in any kind of industry, especially in processing, is very important and complex. This paper develops a new method for occupational risk assessment in the presence of uncertainties. Uncertain values of hazardous factors and consequence frequencies are described with linguistic expressions defined by a safety management team. They are modeled with fuzzy sets. Consequence severities depend on current hazardous factors, and their values are calculated with the proposed procedure. The proposed model is tested with real-life data from fruit processing firms in Central Serbia.

Error reduction, patient safety and institutional ethics committees.

PubMed

Meaney, Mark E

2004-01-01

Institutional ethics committees remain largely absent from the literature on error reduction and patient safety. In this paper, the author endeavors to fill the gap. As noted in the Hastings Center's recent report, "Promoting Patient Safety," the occurrence of medical error involves complex web of multiple factors. Human misstep is certainly one such factor, but not the only one. This paper builds on the Hastings Center's report in arguing that institutional ethics committees ought to play an integral role in the transformation of a "culture of blame" to a "culture of safety" in healthcare delivery.

Ab initio chemical safety assessment: A workflow based on exposure considerations and non-animal methods.

PubMed

Berggren, Elisabet; White, Andrew; Ouedraogo, Gladys; Paini, Alicia; Richarz, Andrea-Nicole; Bois, Frederic Y; Exner, Thomas; Leite, Sofia; Grunsven, Leo A van; Worth, Andrew; Mahony, Catherine

2017-11-01

We describe and illustrate a workflow for chemical safety assessment that completely avoids animal testing. The workflow, which was developed within the SEURAT-1 initiative, is designed to be applicable to cosmetic ingredients as well as to other types of chemicals, e.g. active ingredients in plant protection products, biocides or pharmaceuticals. The aim of this work was to develop a workflow to assess chemical safety without relying on any animal testing, but instead constructing a hypothesis based on existing data, in silico modelling, biokinetic considerations and then by targeted non-animal testing. For illustrative purposes, we consider a hypothetical new ingredient x as a new component in a body lotion formulation. The workflow is divided into tiers in which points of departure are established through in vitro testing and in silico prediction, as the basis for estimating a safe external dose in a repeated use scenario. The workflow includes a series of possible exit (decision) points, with increasing levels of confidence, based on the sequential application of the Threshold of Toxicological (TTC) approach, read-across, followed by an "ab initio" assessment, in which chemical safety is determined entirely by new in vitro testing and in vitro to in vivo extrapolation by means of mathematical modelling. We believe that this workflow could be applied as a tool to inform targeted and toxicologically relevant in vitro testing, where necessary, and to gain confidence in safety decision making without the need for animal testing.

Assessment of Driving Safety in Older Adults with Mild Cognitive Impairment.

PubMed

Anstey, Kaarin J; Eramudugolla, Ranmalee; Chopra, Sidhant; Price, Jasmine; Wood, Joanne M

2017-01-01

With population aging, drivers with mild cognitive impairment (MCI) are increasing; however, there is little evidence available regarding their safety. We aimed to evaluate risk of unsafe on-road driving performance among older adults with MCI. The study was a cross-sectional observational study, set in Canberra, Australia. Participants were non-demented, current drivers (n = 302) aged 65 to 96 years (M = 75.7, SD = 6.18, 40% female) recruited through the community and primary and tertiary care clinics. Measures included a standardized on-road driving test (ORT), a battery of screening measures designed to evaluate older driver safety (UFOV®, DriveSafe, Multi-D), a neurocognitive test battery, and questionnaires on driving history and behavior. Using Winblad criteria, 57 participants were classified as having MCI and 245 as cognitively normal (CN). While the MCI group had a significantly lower overall safety rating on the ORT (5.61 versus 6.05, p = 0.03), there was a wide range of driving safety scores in the CN and MCI groups. The MCI group performed worse than the CN group on the off-road screening tests. The best fitting model of predictors of ORT performance across the combined sample included age, the Multi-D, and DriveSafe, classifying 90.4% of the sample correctly. Adults with MCI exhibit a similar range of driving ability to CN adults, although on average they scored lower on off-road and on-road assessments. Driving specific tests were more strongly associated with safety ratings than traditional neuropsychological tests.

Assessment of Driving Safety in Older Adults with Mild Cognitive Impairment

PubMed Central

Anstey, Kaarin J.; Eramudugolla, Ranmalee; Chopra, Sidhant; Price, Jasmine; Wood, Joanne M.

2017-01-01

Background: With population aging, drivers with mild cognitive impairment (MCI) are increasing; however, there is little evidence available regarding their safety. Objective: We aimed to evaluate risk of unsafe on-road driving performance among older adults with MCI. Method: The study was a cross-sectional observational study, set in Canberra, Australia. Participants were non-demented, current drivers (n = 302) aged 65 to 96 years (M = 75.7, SD = 6.18, 40% female) recruited through the community and primary and tertiary care clinics. Measures included a standardized on-road driving test (ORT), a battery of screening measures designed to evaluate older driver safety (UFOV®, DriveSafe, Multi-D), a neurocognitive test battery, and questionnaires on driving history and behavior. Results: Using Winblad criteria, 57 participants were classified as having MCI and 245 as cognitively normal (CN). While the MCI group had a significantly lower overall safety rating on the ORT (5.61 versus 6.05, p = 0.03), there was a wide range of driving safety scores in the CN and MCI groups. The MCI group performed worse than the CN group on the off-road screening tests. The best fitting model of predictors of ORT performance across the combined sample included age, the Multi-D, and DriveSafe, classifying 90.4% of the sample correctly. Conclusion: Adults with MCI exhibit a similar range of driving ability to CN adults, although on average they scored lower on off-road and on-road assessments. Driving specific tests were more strongly associated with safety ratings than traditional neuropsychological tests. PMID:28372333

Transcolonic Perirectal NOTES Access (PNA): A feasibility study with survival in swine model.

PubMed

Oliveira, André L A; Zorron, Ricardo; Oliveira, Flavio M M DE; Santos, Marcelo B Dos; Scheffer, Jussara P; Rios, Marcelo; Antunes, Fernanda

2017-05-01

Transrectal access still has some unsolved issues such as spatial orientation, infection, access and site closure. This study presents a simple technique to perform transcolonic access with survival in a swine model series. A new technique for NOTES perirectal access to perform retroperitoneoscopy, peritoneoscopy, liver and lymphnode biopsies was performed in 6 pigs, using Totally NOTES technique. The specimens were extracted transanally. The flexible endoscope was inserted through a posterior transmural incision and the retrorectal space. Cultures of bacteria were documented for the retroperitoneal space and intra abdominal cavity after 14 days. Rectal site was closed using non-absorbable sutures. There was no bowel cleansing, nor preoperative fasting. The procedures were performed in 6 pigs through transcolonic natural orifice access using available endoscopic flexible instruments. All animals survived 14 days without complications, and cultures were negative. Histopathologic examination of the rectal closure site showed adequate healing of suture line and no micro abscesses. The results of feasibility and safety of experimental Transcolonic NOTES potentially brings new frontiers and future wider applications for minimally invasive surgery. The treatment of colorectal, abdominal and retroperitoneal diseases through a flexible Perirectal NOTES Access (PNA) is a promising new approach.

Assessment of the culture of safety in public hospitals in Brazil 1

PubMed Central

de Carvalho, Rhanna Emanuela Fontenele Lima; Arruda, Lidyane Parente; do Nascimento, Nayanne Karen Pinheiro; Sampaio, Renata Lopes; Cavalcante, Maria Lígia Silva Nunes; Costa, Ana Carolina Pinto

2017-01-01

ABSTRACT Objective: to assess the culture of safety in three public hospitals. Method: transversal study undertaken in three Brazilian public hospitals, with health professionals through applying the Safety Attitudes Questionnaire (SAQ). Scores greater than or equal to 75 were considered positive. Results: a total of 573 professionals participated in the study, including nurse technicians and auxiliary nurses 292 (51%), nurses 105 (18.3%), physicians 59 (10.3%), and other professionals 117 (20.4%). The mean of the SAQ varied between 65 and 69 in the three hospitals. Among the domains, however, 'Job satisfaction' presented a higher score, and the opposite was observed for the domain 'Perceptions of management'. The outsourced professionals presented a better perception of the culture of safety than did the statutory professionals. The professionals with higher education presented a better perception of the stressing factors than did the professionals educated to senior high school level. Conclusion: the level of the culture of safety found is below the ideal. The managerial actions are considered the main contributing factor to the culture's weakness; however, the professionals demonstrated themselves to be satisfied with the work. PMID:28301029

Safety assessment for EPS electron-proton spectrometer

NASA Technical Reports Server (NTRS)

Gleeson, P.

1971-01-01

A safety analysis was conducted to identify the efforts required to assure relatively hazard free operation of the EPS and to meet the safety requirements of the program. Safety engineering criteria, principles, and techniques in applicable disciplines are stressed in the performance of the system and subsystem studies; in test planning; in the design, development, test, evaluation, and checkout of the equipment; and the operating procedures for the EPS program.

Assessment of Integrated Pedestrian Protection Systems with Autonomous Emergency Braking (AEB) and Passive Safety Components.

PubMed

Edwards, Mervyn; Nathanson, Andrew; Carroll, Jolyon; Wisch, Marcus; Zander, Oliver; Lubbe, Nils

2015-01-01

Autonomous emergency braking (AEB) systems fitted to cars for pedestrians have been predicted to offer substantial benefit. On this basis, consumer rating programs-for example, the European New Car Assessment Programme (Euro NCAP)-are developing rating schemes to encourage fitment of these systems. One of the questions that needs to be answered to do this fully is how the assessment of the speed reduction offered by the AEB is integrated with the current assessment of the passive safety for mitigation of pedestrian injury. Ideally, this should be done on a benefit-related basis. The objective of this research was to develop a benefit-based methodology for assessment of integrated pedestrian protection systems with AEB and passive safety components. The method should include weighting procedures to ensure that it represents injury patterns from accident data and replicates an independently estimated benefit of AEB. A methodology has been developed to calculate the expected societal cost of pedestrian injuries, assuming that all pedestrians in the target population (i.e., pedestrians impacted by the front of a passenger car) are impacted by the car being assessed, taking into account the impact speed reduction offered by the car's AEB (if fitted) and the passive safety protection offered by the car's frontal structure. For rating purposes, the cost for the assessed car is normalized by comparing it to the cost calculated for a reference car. The speed reductions measured in AEB tests are used to determine the speed at which each pedestrian in the target population will be impacted. Injury probabilities for each impact are then calculated using the results from Euro NCAP pedestrian impactor tests and injury risk curves. These injury probabilities are converted into cost using "harm"-type costs for the body regions tested. These costs are weighted and summed. Weighting factors were determined using accident data from Germany and Great Britain and an independently

Impact of biomarker development on drug safety assessment

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

Marrer, Estelle, E-mail: estelle.marrer@novartis.co; Dieterle, Frank

2010-03-01

Drug safety has always been a key aspect of drug development. Recently, the Vioxx case and several cases of serious adverse events being linked to high-profile products have increased the importance of drug safety, especially in the eyes of drug development companies and global regulatory agencies. Safety biomarkers are increasingly being seen as helping to provide the clarity, predictability, and certainty needed to gain confidence in decision making: early-stage projects can be stopped quicker, late-stage projects become less risky. Public and private organizations are investing heavily in terms of time, money and manpower on safety biomarker development. An illustrative andmore » 'door opening' safety biomarker success story is the recent recognition of kidney safety biomarkers for pre-clinical and limited translational contexts by FDA and EMEA. This milestone achieved for kidney biomarkers and the 'know how' acquired is being transferred to other organ toxicities, namely liver, heart, vascular system. New technologies and molecular-based approaches, i.e., molecular pathology as a complement to the classical toolbox, allow promising discoveries in the safety biomarker field. This review will focus on the utility and use of safety biomarkers all along drug development, highlighting the present gaps and opportunities identified in organ toxicity monitoring. A last part will be dedicated to safety biomarker development in general, from identification to diagnostic tests, using the kidney safety biomarkers success as an illustrative example.« less

Blue Note

ScienceCinema

Murray Gibson

2017-12-09

Argonne's Murray Gibson is a physicist whose life's work includes finding patterns among atoms. The love of distinguishing patterns also drives Gibson as a musician and Blues enthusiast."Blue" notes are very harmonic notes that are missing from the equal temperament scale.The techniques of piano blues and jazz represent the melding of African and Western music into something totally new and exciting.

Blue Note

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

Murray Gibson

2007-04-27

Argonne's Murray Gibson is a physicist whose life's work includes finding patterns among atoms. The love of distinguishing patterns also drives Gibson as a musician and Blues enthusiast."Blue" notes are very harmonic notes that are missing from the equal temperament scale.The techniques of piano blues and jazz represent the melding of African and Western music into something totally new and exciting.

Safety Assessment of Diethanolamine and Its 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

The Cosmetic Ingredient Review (CIR) Expert Panel assessed the safety of diethanolamine and its salts as used in cosmetics. Diethanolamine functions as a pH adjuster; the 16 salts included in this rereview reportedly function as surfactants, emulsifying agents, viscosity increasing agents, hair or skin conditioning agents, foam boosters, or antistatic agents. The Panel reviewed available animal and clinical data, as well as information from previous CIR reports. Since data were not available for each individual ingredient, and since the salts dissociate freely in water, the Panel extrapolated from previous reports to support safety. The Panel concluded that diethanolamine and its salts are safe for use when formulated to be nonirritating. These ingredients should not be used in cosmetic products in which N-nitroso compounds can be formed.

Food safety: importance of composition for assessing genetically modified cassava (Manihot esculenta Crantz).

PubMed

van Rijssen, Fredrika W Jansen; Morris, E Jane; Eloff, Jacobus N

2013-09-04

The importance of food composition in safety assessments of genetically modified (GM) food is described for cassava ( Manihot esculenta Crantz) that naturally contains significantly high levels of cyanogenic glycoside (CG) toxicants in roots and leaves. The assessment of the safety of GM cassava would logically require comparison with a non-GM crop with a proven "history of safe use". This study investigates this statement for cassava. A non-GM comparator that qualifies would be a processed product with CG level below the approved maximum level in food and that also satisfies a "worst case" of total dietary consumption. Although acute and chronic toxicity benchmark CG values for humans have been determined, intake data are scarce. Therefore, the non-GM cassava comparator is defined on the "best available knowledge". We consider nutritional values for cassava and conclude that CG residues in food should be a priority topic for research.

Fundamentals of health risk assessment. Use, derivation, validity and limitations of safety indices.

PubMed

Putzrath, R M; Wilson, J D

1999-04-01

We investigated the way results of human health risk assessments are used, and the theory used to describe those methods, sometimes called the "NAS paradigm." Contrary to a key tenet of that theory, current methods have strictly limited utility. The characterizations now considered standard, Safety Indices such as "Acceptable Daily Intake," "Reference Dose," and so on, usefully inform only decisions that require a choice between two policy alternatives (e.g., approve a food additive or not), decided solely on the basis of a finding of safety. Risk is characterized as the quotient of one of these Safety Indices divided by an estimate of exposure: a quotient greater than one implies that the situation may be considered safe. Such decisions are very widespread, both in the U.S. federal government and elsewhere. No current method is universal; different policies lead to different practices, for example, in California's "Proposition 65," where statutory provisions specify some practices. Further, an important kind of human health risk assessment is not recognized by this theory: this kind characterizes risk as likelihood of harm, given estimates of exposure consequent to various decision choices. Likelihood estimates are necessary whenever decision makers have many possible decision choices and must weigh more than two societal values, such as in EPA's implementation of "conventional air pollutants." These estimates can not be derived using current methods; different methods are needed. Our analysis suggests changes needed in both the theory and practice of human health risk assessment, and how what is done is depicted.

The TRIPOD e-learning Platform for the Training of Earthquake Safety Assessment

NASA Astrophysics Data System (ADS)

Coppari, S.; Di Pasquale, G.; Goretti, A.; Papa, F.; Papa, S.; Paoli, G.; Pizza, A. G.; Severino, M.

2008-07-01

The paper summarizes the results of the in progress EU Project titled TRIPOD (Training Civil Engineers on Post-Earthquake Safety Assessment of Damaged Buildings), funded under the Leonardo Da Vinci program. The main theme of the project is the development of a methodology and a learning platform for the training of technicians involved in post-earthquake building safety inspections. In the event of a catastrophic earthquake, emergency building inspections constitute a major undertaking with severe social impact. Given the inevitable chaotic conditions and the urgent need of a great number of specialized individuals to carry out inspections, past experience indicates that inspection teams are often formed in an adhoc manner, under stressful conditions, at a varying levels of technical expertise and experience, sometime impairing the reliability and consistency of the inspection results. Furthermore each Country has its own building damage and safety assessment methodology, developed according to its experience, laws, building technology and seismicity. This holds also for the partners participating to the project (Greece, Italy, Turkey, Cyprus), that all come from seismically sensitive Mediterranean countries. The project aims at alleviating the above shortcomings by designing and developing a training methodology and e-platform, forming a complete training program targeted at inspection engineers, specialized personnel and civil protection agencies. The e-learning platform will provide flexible and friendly authoring mechanisms, self-teaching and assessment capabilities, course and trainee management, etc. Courses will be also made available as stand-alone multimedia applications on CD and in the form of a complete pocket handbook. Moreover the project will offer the possibility of upgrading different experiences and practices: a first step towards the harmonization of methodologies and tools of different Countries sharing similar problems. Finally, through wide

Assessment of safety culture in isfahan hospitals (2010).

PubMed

Raeisi, Ahmed Reza; Nazari, Maryam; Bahmanziari, Najme

2013-01-01

Many internal and external risk factors in health care organizations make safety important and it has caused the management to consider safety in their mission statement. One of the most important tools is to establish the appropriate organizational structure and safety culture. The goal of this research is to inform managers and staff about current safety culture status in hospitals in order to improve the efficiency and effectiveness of health services. This is a descriptive-survey research. The research population was selected hospitals of Isfahan, Iran. Research tool was a questionnaire (Cronbach alpha 0.75). The questionnaire including 93 questions (Likert scale) classified in 12 categories: Demographic questions, Individual attitude, management attitude, Safety Training, Induced stress, pressure and emotional conditions during work, Consultation and participation, Communications, Monitoring and control, work environment, Reporting, safety Rules, procedures and work instructions that distributed among 45 technicians, 208 Nurses and 62 Physicians. All data collected from the serve was analysis with statistical package of social science (SPSS). In this survey Friedman test, Spearman correlation, analysis of variance (ANOVA) and factor analysis have been used for data analyzing. The score of safety culture dimensions was 2.90 for Individual attitude, 3.12 for management attitude, 3.32 for Safety Training, 3.14 for Induced stress, pressure and emotional conditions during work, 3.31 for Consultation and participation, 2.93 for Communications, 3.28 for Monitoring and control, 3.19 for work environment, 3.36 for Reporting, 3.59 safety Rules, procedures and work instructions that Communication and individual attitude were in bad condition. Safety culture among different hospitals: governmental and educational, governmental and non-educational and non-governmental and different functional groups (physicians, nurses, diagnostic) of studied hospitals showed no

Cleaning and asthma: A systematic review and approach for effective safety assessment.

PubMed

Vincent, Melissa J; Parker, Ann; Maier, Andrew

2017-11-01

Research indicates a correlative relationship between asthma and use of consumer cleaning products. We conduct a systematic review of epidemiological literature on persons who use or are exposed to cleaning products, both in occupational and domestic settings, and risk of asthma or asthma-like symptoms to improve understanding of the causal relationship between exposure and asthma. A scoring method for assessing study reliability is presented. Although research indicates an association between asthma and the use of cleaning products, no study robustly investigates exposure to cleaning products or ingredients along with asthma risk. This limits determination of causal relationships between asthma and specific products or ingredients in chemical safety assessment. These limitations, and a lack of robust animal models for toxicological assessment of asthma, create the need for a weight-of-evidence (WoE) approach to examine an ingredient or product's asthmatic potential. This proposed WoE method organizes diverse lines of data (i.e., asthma, sensitization, and irritation information) through a systematic, hierarchical framework that provides qualitatively categorized conclusions using hazard bands to predict a specific product or ingredient's potential for asthma induction. This work provides a method for prioritizing chemicals as a first step for quantitative and scenario-specific safety assessments based on their potential for inducing asthmatic effects. Acetic acid is used as a case study to test this framework. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Liver safety assessment in special populations (hepatitis B, C, and oncology trials).

PubMed

Kullak-Ublick, Gerd A; Merz, Michael; Griffel, Louis; Kaplowitz, Neil; Watkins, Paul B

2014-11-01

The FDA guidance for industry in the premarketing clinical evaluation of drug-induced liver injury (DILI) is the most specific regulatory guidance currently available and has been useful in setting standards for the great majority of clinical indications involving subjects with a low risk of liver disorders. However, liver safety assessment faces challenges in populations with underlying liver disease, such as viral hepatitis or metastatic cancer. This is an important issue because there are currently many promising anti-viral and oncologic therapies in clinical development, with a trend toward oral therapies with reduced side effects. Without clearer guidelines, questions regarding liver safety may become a major factor in regulatory approval and ultimately physician uptake of the new treatments. The lack of consensus in defining stopping rules based on serum alanine aminotransferase (ALT) levels underscores the need for precompetitive data sharing to improve our understanding of DILI in these populations and to allow evidence-based rather than empirical definition of stopping rules. A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials.

Practice-Based Evidence: Profiling the Safety of Cilostazol by Text-Mining of Clinical Notes

PubMed Central

Iyer, Srinivasan V.; LePendu, Paea; Olson, Cliff; Shah, Nigam H.

2013-01-01

Background Peripheral arterial disease (PAD) is a growing problem with few available therapies. Cilostazol is the only FDA-approved medication with a class I indication for intermittent claudication, but carries a black box warning due to concerns for increased cardiovascular mortality. To assess the validity of this black box warning, we employed a novel text-analytics pipeline to quantify the adverse events associated with Cilostazol use in a clinical setting, including patients with congestive heart failure (CHF). Methods and Results We analyzed the electronic medical records of 1.8 million subjects from the Stanford clinical data warehouse spanning 18 years using a novel text-mining/statistical analytics pipeline. We identified 232 PAD patients taking Cilostazol and created a control group of 1,160 PAD patients not taking this drug using 1∶5 propensity-score matching. Over a mean follow up of 4.2 years, we observed no association between Cilostazol use and any major adverse cardiovascular event including stroke (OR = 1.13, CI [0.82, 1.55]), myocardial infarction (OR = 1.00, CI [0.71, 1.39]), or death (OR = 0.86, CI [0.63, 1.18]). Cilostazol was not associated with an increase in any arrhythmic complication. We also identified a subset of CHF patients who were prescribed Cilostazol despite its black box warning, and found that it did not increase mortality in this high-risk group of patients. Conclusions This proof of principle study shows the potential of text-analytics to mine clinical data warehouses to uncover ‘natural experiments’ such as the use of Cilostazol in CHF patients. We envision this method will have broad applications for examining difficult to test clinical hypotheses and to aid in post-marketing drug safety surveillance. Moreover, our observations argue for a prospective study to examine the validity of a drug safety warning that may be unnecessarily limiting the use of an efficacious therapy. PMID:23717437

Applicability and feasibility of systematic review for performing evidence-based risk assessment in food and feed safety.

PubMed

Aiassa, E; Higgins, J P T; Frampton, G K; Greiner, M; Afonso, A; Amzal, B; Deeks, J; Dorne, J-L; Glanville, J; Lövei, G L; Nienstedt, K; O'connor, A M; Pullin, A S; Rajić, A; Verloo, D

2015-01-01

Food and feed safety risk assessment uses multi-parameter models to evaluate the likelihood of adverse events associated with exposure to hazards in human health, plant health, animal health, animal welfare, and the environment. Systematic review and meta-analysis are established methods for answering questions in health care, and can be implemented to minimize biases in food and feed safety risk assessment. However, no methodological frameworks exist for refining risk assessment multi-parameter models into questions suitable for systematic review, and use of meta-analysis to estimate all parameters required by a risk model may not be always feasible. This paper describes novel approaches for determining question suitability and for prioritizing questions for systematic review in this area. Risk assessment questions that aim to estimate a parameter are likely to be suitable for systematic review. Such questions can be structured by their "key elements" [e.g., for intervention questions, the population(s), intervention(s), comparator(s), and outcome(s)]. Prioritization of questions to be addressed by systematic review relies on the likely impact and related uncertainty of individual parameters in the risk model. This approach to planning and prioritizing systematic review seems to have useful implications for producing evidence-based food and feed safety risk assessment.

Risk assessment for safety laboratories in Politeknik Negeri Medan

NASA Astrophysics Data System (ADS)

Viyata Sundawa, Bakti; Hutajulu, Elferida; Sirait, Regina; Banurea, Waldemar; Indrayadi; Mulyadi, Sangap

2017-09-01

International Labour Organization (ILO) estimated 2.34 million people die each year because accidents and diseases in workplace. It also impact to economic losses in some countries. It need to do safety and healthy in working environment especially in laboratory. Identification of potential hazards and risks must be done in Telecommunication Laboratory Politeknik Negeri Medan. Therefore, this study was assessed 5 of potential hazards and risks in our laboratory by Likert Scale. This object was divided into 2 assessment namely likelihood of hazards and severity of consequences. Collecting data is taken from questionnaire who involved 100 students at random academic level. The result showed The highest score is chemical hazards 73.2% in likelihood of hazards and electrical hazards 85% in severity of consequences. This condition is classified as “high” state. Big attention must be given to “high” state because it can help us to determine mitigate action.

A cross-sectional study to assess the patient safety culture in the Palestinian hospitals: a baseline assessment for quality improvement.

PubMed

Elsous, Aymen; Akbari Sari, Ali; Rashidian, Arash; Aljeesh, Yousef; Radwan, Mahmoud; AbuZaydeh, Hatem

2016-12-01

To measure and establish a baseline assessment of the patient safety culture in the Palestinian hospitals. A cross-sectional descriptive study using the Arabic version of the Safety Attitude Questionnaire (Short Form 2006). A total of 339 nurses and physicians returned the questionnaire out of 370 achieving a response rate of 91.6%. Four public general hospitals in the Gaza Strip, Palestine. Nurses and physicians were randomly selected using a proportionate random sampling. Data analysis performed using Statistical Package for the Social Sciences software version 20, and p value less than 0.05 was statistically significant. Current status of patient safety culture among healthcare providers and percentage of positive attitudes. Male to female ratio was 2.16:1, and mean age was 36.5 ± 9.4 years. The mean score of Arabic Safety Attitude Questionnaire across the six dimensions on 100-point scale ranged between 68.5 for Job Satisfaction and 48.5 for Working Condition. The percentage of respondents holding a positive attitude was 34.5% for Teamwork Climate, 28.4% for Safety Climate, 40.7% for Stress Recognition, 48.8% for Job Satisfaction, 11.3% for Working Conditions and 42.8% for Perception of Management. Healthcare workers holding positive attitudes had better collaboration with co-workers than those without positive attitudes. Findings are useful to formulate a policy on patient safety culture and targeted a specific safety culture dimension to improve the safety of patients and improve the clinical outcomes within healthcare organisations.

Safety culture perceptions of pharmacists in Malaysian hospitals and health clinics: a multicentre assessment using the Safety Attitudes Questionnaire.

PubMed

Samsuri, Srima Elina; Pei Lin, Lua; Fahrni, Mathumalar Loganathan

2015-11-26

To assess the safety attitudes of pharmacists, provide a profile of their domains of safety attitude and correlate their attitudes with self-reported rates of medication errors. A cross-sectional study utilising the Safety Attitudes Questionnaire (SAQ). 3 public hospitals and 27 health clinics. 117 pharmacists. Safety culture mean scores, variation in scores across working units and between hospitals versus health clinics, predictors of safety culture, and medication errors and their correlation. Response rate was 83.6% (117 valid questionnaires returned). Stress recognition (73.0±20.4) and working condition (54.8±17.4) received the highest and lowest mean scores, respectively. Pharmacists exhibited positive attitudes towards: stress recognition (58.1%), job satisfaction (46.2%), teamwork climate (38.5%), safety climate (33.3%), perception of management (29.9%) and working condition (15.4%). With the exception of stress recognition, those who worked in health clinics scored higher than those in hospitals (p<0.05) and higher scores (overall score as well as score for each domain except for stress recognition) correlated negatively with reported number of medication errors. Conversely, those working in hospital (versus health clinic) were 8.9 times more likely (p<0.01) to report a medication error (OR 8.9, CI 3.08 to 25.7). As stress recognition increased, the number of medication errors reported increased (p=0.023). Years of work experience (p=0.017) influenced the number of medication errors reported. For every additional year of work experience, pharmacists were 0.87 times less likely to report a medication error (OR 0.87, CI 0.78 to 0.98). A minority (20.5%) of the pharmacists working in hospitals and health clinics was in agreement with the overall SAQ questions and scales. Pharmacists in outpatient and ambulatory units and those in health clinics had better perceptions of safety culture. As perceptions improved, the number of medication errors reported

The Systems SOAP Note: A Systems Learning Tool.

PubMed

Mitsuishi, Fumi; Young, John Q; Leary, Mark; Dilley, James; Mangurian, Christina

2016-02-01

Systems-based practice (SBP) is the only Accreditation Council for Graduate Medical Education (ACGME) competency concerned with public health and is relatively neglected in residency curricula. A tool was developed and pilot-tested to improve SBP learning on inpatient psychiatry rotations. A four-step approach was used: (1) literature review, (2) expert consultation, (3) tool development, and (4) pilot testing on four cases and evaluation for completion time and preliminary efficacy. Out of 51 SBP articles, six (12%) focused on psychiatric residency programs, and none had a practical SBP learning tool. The "systems SOAP (subjective, objective, assessment, plan) note" (S-SOAP) was structured after a clinical SOAP note and was easy to use (mean completion time = 60 min), and residents self-reported more insight into systems issues. The S-SOAP tool was effectively integrated into clinical experience and provided insight into systemic complexities. Future research should assess SBP knowledge acquisition after the use of such tools.

LUVOIR Tech Notes

NASA Technical Reports Server (NTRS)

Bolcar, Matthew R.; Shaklan, Stuart; Roberge, Aki; Rioux, Norman; Feinberg, Lee; Werner, Michael; Rauscher, Bernard; Mandell, Avi; France, Kevin; Schiminovich, David

2016-01-01

We present nine "tech notes" prepared by the Large UV/Optical/Infrared (LUVOIR) Science and Technology Definition Team (STDT), Study Office, and Technology Working Group. These tech notes are intended to highlight technical challenges that represent boundaries in the trade space for developing the LUVOIR architecture that may impact the science objectives being developed by the STDT. These tech notes are intended to be high-level discussions of the technical challenges and will serve as starting points for more in-depth analysis as the LUVOIR study progresses.

1. On note taking.

PubMed

Plaut, Alfred B J

2005-02-01

In this paper the author explores the theoretical and technical issues relating to taking notes of analytic sessions, using an introspective approach. The paper discusses the lack of a consistent approach to note taking amongst analysts and sets out to demonstrate that systematic note taking can be helpful to the analyst. The author describes his discovery that an initial phase where as much data was recorded as possible did not prove to be reliably helpful in clinical work and initially actively interfered with recall in subsequent sessions. The impact of the nature of the analytic session itself and the focus of the analyst's interest on recall is discussed. The author then describes how he modified his note taking technique to classify information from sessions into four categories which enabled the analyst to select which information to record in notes. The characteristics of memory and its constructive nature are discussed in relation to the problems that arise in making accurate notes of analytic sessions.

Effects of a team-based assessment and intervention on patient safety culture in general practice: an open randomised controlled trial.

PubMed

Hoffmann, B; Müller, V; Rochon, J; Gondan, M; Müller, B; Albay, Z; Weppler, K; Leifermann, M; Mießner, C; Güthlin, C; Parker, D; Hofinger, G; Gerlach, F M

2014-01-01

The measurement of safety culture in healthcare is generally regarded as a first step towards improvement. Based on a self-assessment of safety culture, the Frankfurt Patient Safety Matrix (FraTrix) aims to enable healthcare teams to improve safety culture in their organisations. In this study we assessed the effects of FraTrix on safety culture in general practice. We conducted an open randomised controlled trial in 60 general practices. FraTrix was applied over a period of 9 months during three facilitated team sessions in intervention practices. At baseline and after 12 months, scores were allocated for safety culture as expressed in practice structure and processes (indicators), in safety climate and in patient safety incident reporting. The primary outcome was the indicator error management. During the team sessions, practice teams reflected on their safety culture and decided on about 10 actions per practice to improve it. After 12 months, no significant differences were found between intervention and control groups in terms of error management (competing probability=0.48, 95% CI 0.34 to 0.63, p=0.823), 11 further patient safety culture indicators and safety climate scales. Intervention practices showed better reporting of patient safety incidents, reflected in a higher number of incident reports (mean (SD) 4.85 (4.94) vs 3.10 (5.42), p=0.045) and incident reports of higher quality (scoring 2.27 (1.93) vs 1.49 (1.67), p=0.038) than control practices. Applied as a team-based instrument to assess safety culture, FraTrix did not lead to measurable improvements in error management. Comparable studies with more positive results had less robust study designs. In future research, validated combined methods to measure safety culture will be required. In addition, more attention should be paid to evaluation of process parameters. Implemented actions and incident reporting may be more appropriate target endpoints. German Clinical Trials Register (Deutsches Register

Assessment of documentation requirements under DOE 5481. 1, Safety Analysis and Review System (SARS)

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

Browne, E.T.

1981-03-01

This report assesses the requirements of DOE Order 5481.1, Safety Analysis and Review System for DOE Operations (SARS) in regard to maintaining SARS documentation. Under SARS, all pertinent details of the entire safety analysis and review process for each DOE operation are to be traceable from the initial identification of a hazard. This report is intended to provide assistance in identifying the points in the SARS cycle at which documentation is required, what type of documentation is most appropriate, and where it ultimately should be maintained.

Safety and nutritional assessment of GM plants and derived food and feed: the role of animal feeding trials.

PubMed

2008-03-01

changes in the level of natural constituents beyond normal variation, and on the characteristics of the GM food and feed, and (ii) the possible occurrence of unintended (unexpected) effects in GM plants due to genetic modification. In order to identify these effects a comparative phenotypic and molecular analysis of the GM plant and its near isogenic counterpart is carried out, in parallel with a targeted analysis of single specific compounds, which represent important metabolic pathways in the plant like macro and micro nutrients, known anti-nutrients and toxins. Significant differences may be indicative of the occurrence of unintended effects, which require further investigation. Section 2 provides an overview of studies performed for the safety and nutritional assessment of whole food and feed. Extensive experience has been built up in recent decades from the safety and nutritional testing in animals of irradiated foods, novel foods and fruit and vegetables. These approaches are also relevant for the safety and nutritional testing of whole GM food and feed. Many feeding trials have been reported in which GM foods like maize, potatoes, rice, soybeans and tomatoes have been fed to rats or mice for prolonged periods, and parameters such as body weight, feed consumption, blood chemistry, organ weights, histopathology etc have been measured. The food and feed under investigation were derived from GM plants with improved agronomic characteristics like herbicide tolerance and/or insect resistance. The majority of these experiments did not indicate clinical effects or histopathological abnormalities in organs or tissues of exposed animals. In some cases adverse effects were noted, which were difficult to interpret due to shortcomings in the studies. Many studies have also been carried out with feed derived from GM plants with agronomic input traits in target animal species to assess the nutritive value of the feed and their performance potential. Studies in sheep, pigs

Supervisors Guidebook: Driver and Traffic Safety Education.

ERIC Educational Resources Information Center

Aaron, James E.; And Others

Intended for those responsible to organize, oversee, and evaluate a school's comprehensive traffic safety education program, this Illinois State guide contains nine major sections and appendixes. An introduction presents philosophy and status of the Illinois program, general goals and objectives, notes on relevant professional associations, and…

Use of assessment to reinforce patient safety as a habit

PubMed Central

Galbraith, R M; Holtman, M C; Clyman, S G

2006-01-01

The US spends far more than any other nation on health care. Physicians undergo lengthy and comprehensive training that is carefully scrutinized, and are held to high standards in national examinations. At best the care delivered matches or exceeds that in any other country. And yet, often simple preventable medical errors occur at alarming and unacceptable rates. The public, corporate consumers of health care, large payors and malpractice insurance carriers are all becoming impatient with the pace of improvement. The medical profession recognizes that dealing with this problem is an urgent priority and is grappling to find the best approaches. This paper focuses on the constructive use of assessment to embed a pervasive and proactive culture of patient safety into practice, starting with the trainee and extending out into the practice years. This strategy is based on the adage that “assessment drives curriculum” and proposes a series of new assessment tools to be added to all phases of the training‐practice continuum. PMID:17142605

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.

CRITICALITY SAFETY CONTROLS AND THE SAFETY BASIS AT PFP

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

Kessler, S

2009-04-21

-2007. In reviewing documents used in classifying controls for Nuclear Safety, it was noted that DOE-HDBK-1188, 'Glossary of Environment, Health, and Safety Terms', defines an Administrative Control (AC) in terms that are different than typically used in Criticality Safety. As part of this CCR, a new term, Criticality Administrative Control (CAC) was defined to clarify the difference between an AC used for criticality safety and an AC used for nuclear safety. In Nuclear Safety terms, an AC is a provision relating to organization and management, procedures, recordkeeping, assessment, and reporting necessary to ensure safe operation of a facility. A CAC was defined as an administrative control derived in a criticality safety analysis that is implemented to ensure double contingency. According to criterion 2 of Section IV, 'Linkage to the Documented Safety Analysis', of DOESTD-3007-2007, the consequence of a criticality should be examined for the purposes of classifying the significance of a control or component. HNF-PRO-700, 'Safety Basis Development', provides control selection criteria based on consequence and risk that may be used in the development of a Criticality Safety Evaluation (CSE) to establish the classification of a component as a design feature, as safety class or safety significant, i.e., an Engineered Safety Feature (ESF), or as equipment important to safety; or merely provides defense-in-depth. Similar logic is applied to the CACs. Criterion 8C of DOE-STD-3007-2007, as written, added to the confusion of using the basic CCR from HNF-7098. The PFP CCR attempts to clarify this criterion by revising it to say 'Programmatic commitments or general references to control philosophy (e.g., mass control or spacing control or concentration control as an overall control strategy for the process without specific quantification of individual limits) is included in the PFP DSA'. Table 1 shows the PFP methodology for evaluating CACs. This evaluation process has been in use

Giving women their own case notes to carry during pregnancy.

PubMed

Brown, Heather C; Smith, Helen J; Mori, Rintaro; Noma, Hisashi

2015-10-14

In many countries women are given their own case notes to carry during pregnancy to increase their sense of control over, and satisfaction with, their care. To evaluate the effects of giving women their own case notes to carry during pregnancy. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 August 2015) and reference lists of retrieved studies. Randomised controlled trials of women given their own case notes to carry during pregnancy. Two review authors independently applied the inclusion criteria and assessed study quality. One review author extracted data from the included studies using a standard form (checked by second review author). We assessed estimates of effect using risk ratio (RR) with 95% confidence intervals (CI). The quality of the evidence was assessed using the GRADE approach. Four trials were included (n = 1176 women). Overall, the quality of the evidence was graded as low to moderate mainly due to the nature of the intervention not allowing blinding. The updated search identified one cluster-randomised trial, which was included.Women carrying their own notes were more likely to feel in control (two trials, RR 1.56, 95% CI 1.18 to 2.06; 450 women; moderate quality evidence), although there is no evidence of difference in women's satisfaction (two trials, average RR 1.09, 95% CI 0.92 to 1.29); 698 women; low quality evidence). More women in the case notes group wanted to carry their own notes in a subsequent pregnancy (three trials, RR 1.79, 95% CI 1.57 to 2.03; 552 women; low quality evidence). Overall, the pooled estimate of the two trials (n = 347) that reported on the risk of notes lost or left at home was not significant (average RR 0.38, 95% CI 0.04 to 3.84). There was no evidence of difference for health-related behaviours (cigarette smoking and breastfeeding (moderate quality evidence)), analgesia needs during labour (low quality evidence), maternal depression, miscarriage, stillbirth and neonatal deaths

Note Taking and Recall

ERIC Educational Resources Information Center

Fisher, Judith L.; Harris, Mary B.

1974-01-01

To study the effect of note taking and opportunity for review on subsequent recall, 88 college students were randomly assigned to five treatment groups utilizing different note taking and review combinations. No treatment effects were found, although quality of notes was positively correlated with free recall an multiple-choice measures.…

Managing risk in healthcare: understanding your safety culture using the Manchester Patient Safety Framework (MaPSaF).

PubMed

Parker, Dianne

2009-03-01

To provide sufficient information about the Manchester Patient Safety Framework (MaPSaF) to allow healthcare professionals to assess its potential usefulness. The assessment of safety culture is an important aspect of risk management, and one in which there is increasing interest among healthcare organizations. Manchester Patient Safety Framework offers a theory-based framework for assessing safety culture, designed specifically for use in the NHS. The framework covers multiple dimensions of safety culture, and five levels of safety culture development. This allows the generation of a profile of an organization's safety culture in terms of areas of relative strength and challenge, which can be used to identify focus issues for change and improvement. Manchester Patient Safety Framework provides a useful method for engaging healthcare professionals in assessing and improving the safety culture in their organization, as part of a programme of risk management.