The MINERVA Software Development Process

NASA Technical Reports Server (NTRS)

Narkawicz, Anthony; Munoz, Cesar A.; Dutle, Aaron M.

2017-01-01

This paper presents a software development process for safety-critical software components of cyber-physical systems. The process is called MINERVA, which stands for Mirrored Implementation Numerically Evaluated against Rigorously Verified Algorithms. The process relies on formal methods for rigorously validating code against its requirements. The software development process uses: (1) a formal specification language for describing the algorithms and their functional requirements, (2) an interactive theorem prover for formally verifying the correctness of the algorithms, (3) test cases that stress the code, and (4) numerical evaluation on these test cases of both the algorithm specifications and their implementations in code. The MINERVA process is illustrated in this paper with an application to geo-containment algorithms for unmanned aircraft systems. These algorithms ensure that the position of an aircraft never leaves a predetermined polygon region and provide recovery maneuvers when the region is inadvertently exited.

Structuring Formal Control Systems Specifications for Reuse: Surviving Hardware Changes

NASA Technical Reports Server (NTRS)

Thompson, Jeffrey M.; Heimdahl, Mats P. E.; Erickson, Debra M.

2000-01-01

Formal capture and analysis of the required behavior of control systems have many advantages. For instance, it encourages rigorous requirements analysis, the required behavior is unambiguously defined, and we can assure that various safety properties are satisfied. Formal modeling is, however, a costly and time consuming process and if one could reuse the formal models over a family of products, significant cost savings would be realized. In an ongoing project we are investigating how to structure state-based models to achieve a high level of reusability within product families. In this paper we discuss a high-level structure of requirements models that achieves reusability of the desired control behavior across varying hardware platforms in a product family. The structuring approach is demonstrated through a case study in the mobile robotics domain where the desired robot behavior is reused on two diverse platforms-one commercial mobile platform and one build in-house. We use our language RSML (-e) to capture the control behavior for reuse and our tool NIMBUS to demonstrate how the formal specification can be validated and used as a prototype on the two platforms.

Advanced Software V&V for Civil Aviation and Autonomy

NASA Technical Reports Server (NTRS)

Brat, Guillaume P.

2017-01-01

With the advances in high-computing platform (e.g., advanced graphical processing units or multi-core processors), computationally-intensive software techniques such as the ones used in artificial intelligence or formal methods have provided us with an opportunity to further increase safety in the aviation industry. Some of these techniques have facilitated building safety at design time, like in aircraft engines or software verification and validation, and others can introduce safety benefits during operations as long as we adapt our processes. In this talk, I will present how NASA is taking advantage of these new software techniques to build in safety at design time through advanced software verification and validation, which can be applied earlier and earlier in the design life cycle and thus help also reduce the cost of aviation assurance. I will then show how run-time techniques (such as runtime assurance or data analytics) offer us a chance to catch even more complex problems, even in the face of changing and unpredictable environments. These new techniques will be extremely useful as our aviation systems become more complex and more autonomous.

Unmanned Aircraft Systems in the National Airspace System: A Formal Methods Perspective

NASA Technical Reports Server (NTRS)

Munoz, Cesar A.; Dutle, Aaron; Narkawicz, Anthony; Upchurch, Jason

2016-01-01

As the technological and operational capabilities of unmanned aircraft systems (UAS) have grown, so too have international efforts to integrate UAS into civil airspace. However, one of the major concerns that must be addressed in realizing this integration is that of safety. For example, UAS lack an on-board pilot to comply with the legal requirement that pilots see and avoid other aircraft. This requirement has motivated the development of a detect and avoid (DAA) capability for UAS that provides situational awareness and maneuver guidance to UAS operators to aid them in avoiding and remaining well clear of other aircraft in the airspace. The NASA Langley Research Center Formal Methods group has played a fundamental role in the development of this capability. This article gives a selected survey of the formal methods work conducted in support of the development of a DAA concept for UAS. This work includes specification of low-level and high-level functional requirements, formal verification of algorithms, and rigorous validation of software implementations.

Fuzzy Logic Controller Stability Analysis Using a Satisfiability Modulo Theories Approach

NASA Technical Reports Server (NTRS)

Arnett, Timothy; Cook, Brandon; Clark, Matthew A.; Rattan, Kuldip

2017-01-01

While many widely accepted methods and techniques exist for validation and verification of traditional controllers, at this time no solutions have been accepted for Fuzzy Logic Controllers (FLCs). Due to the highly nonlinear nature of such systems, and the fact that developing a valid FLC does not require a mathematical model of the system, it is quite difficult to use conventional techniques to prove controller stability. Since safety-critical systems must be tested and verified to work as expected for all possible circumstances, the fact that FLC controllers cannot be tested to achieve such requirements poses limitations on the applications for such technology. Therefore, alternative methods for verification and validation of FLCs needs to be explored. In this study, a novel approach using formal verification methods to ensure the stability of a FLC is proposed. Main research challenges include specification of requirements for a complex system, conversion of a traditional FLC to a piecewise polynomial representation, and using a formal verification tool in a nonlinear solution space. Using the proposed architecture, the Fuzzy Logic Controller was found to always generate negative feedback, but inconclusive for Lyapunov stability.

The relationship between organizational leadership for safety and learning from patient safety events.

PubMed

Ginsburg, Liane R; Chuang, You-Ta; Berta, Whitney Blair; Norton, Peter G; Ng, Peggy; Tregunno, Deborah; Richardson, Julia

2010-06-01

To examine the relationship between organizational leadership for patient safety and five types of learning from patient safety events (PSEs). Forty-nine general acute care hospitals in Ontario, Canada. A nonexperimental design using cross-sectional surveys of hospital patient safety officers (PSOs) and patient care managers (PCMs). PSOs provided data on organization-level learning from (a) minor events, (b) moderate events, (c) major near misses, (d) major event analysis, and (e) major event dissemination/communication. PCMs provided data on organizational leadership (formal and informal) for patient safety. Hospitals were the unit of analysis. Seemingly unrelated regression was used to examine the influence of formal and informal leadership for safety on the five types of learning from PSEs. The interaction between leadership and hospital size was also examined. Formal organizational leadership for patient safety is an important predictor of learning from minor, moderate, and major near-miss events, and major event dissemination. This relationship is significantly stronger for small hospitals (<100 beds). We find support for the relationship between patient safety leadership and patient safety behaviors such as learning from safety events. Formal leadership support for safety is of particular importance in small organizations where the economic burden of safety programs is disproportionately large and formal leadership is closer to the front lines.

49 CFR 238.603 - Safety planning requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... acceptable level using a formal safety methodology such as MIL-STD-882; and (4) Impose operational... using a formal safety methodology such as MIL-STD-882; (5) Monitor the progress in resolving safety...

49 CFR 238.603 - Safety planning requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... acceptable level using a formal safety methodology such as MIL-STD-882; and (4) Impose operational... using a formal safety methodology such as MIL-STD-882; (5) Monitor the progress in resolving safety...

Formal Foundations for Hierarchical Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh; Whiteside, Iain

2015-01-01

Safety cases are increasingly being required in many safety-critical domains to assure, using structured argumentation and evidence, that a system is acceptably safe. However, comprehensive system-wide safety arguments present appreciable challenges to develop, understand, evaluate, and manage, partly due to the volume of information that they aggregate, such as the results of hazard analysis, requirements analysis, testing, formal verification, and other engineering activities. Previously, we have proposed hierarchical safety cases, hicases, to aid the comprehension of safety case argument structures. In this paper, we build on a formal notion of safety case to formalise the use of hierarchy as a structuring technique, and show that hicases satisfy several desirable properties. Our aim is to provide a formal, theoretical foundation for safety cases. In particular, we believe that tools for high assurance systems should be granted similar assurance to the systems to which they are applied. To this end, we formally specify and prove the correctness of key operations for constructing and managing hicases, which gives the specification for implementing hicases in AdvoCATE, our toolset for safety case automation. We motivate and explain the theory with the help of a simple running example, extracted from a real safety case and developed using AdvoCATE.

Do we know what foundation year doctors think about patient safety incident reporting? Development of a Web based tool to assess attitude and knowledge.

PubMed

Robson, Jean; de Wet, Carl; McKay, John; Bowie, Paul

2011-11-01

Making healthcare safer is an international priority. Patient safety modules are now taught in medical schools, and methods to assess related student knowledge and attitudes have been developed. However, little is known about the attitudes and knowledge which foundation doctors are developing to patient safety and incident reporting in the healthcare workplace, since a specific assessment tool appears to be lacking. To develop, content validate and pilot test an online questionnaire survey to elicit foundation doctors' knowledge and experience of patient safety and incident reporting, and assess related attitudes and behaviours. Questionnaire content validity was facilitated through: a steering group; literature review; feedback from foundation year doctors and consultant staff; a modified Delphi group; and completion of a content validity index by experts. In 2010 a cross-sectional online survey of 110 foundation year 1 and 2 doctors was then undertaken in three Scottish NHS board areas, utilising the developed 25 item questionnaire. The questionnaire was validated, and piloted among 69 foundation year doctors who responded to the questionnaire. The pilot has provided valuable insights into trainee attitudes and experience. For example, 32 (48%) believed that most safety incidents were due to things that they could not do anything about; and 31 (43%) admitted to being involved in medication errors which were not formally reported. The pilot study was successful in taking the first steps to developing a validated survey questionnaire for a key staff group, foundation year doctors, in a priority area. However, the findings raise concerns about trainee experience of and attitudes to reporting, and the frequency with which incidents go unreported.

Formalizing Probabilistic Safety Claims

NASA Technical Reports Server (NTRS)

Herencia-Zapana, Heber; Hagen, George E.; Narkawicz, Anthony J.

2011-01-01

A safety claim for a system is a statement that the system, which is subject to hazardous conditions, satisfies a given set of properties. Following work by John Rushby and Bev Littlewood, this paper presents a mathematical framework that can be used to state and formally prove probabilistic safety claims. It also enables hazardous conditions, their uncertainties, and their interactions to be integrated into the safety claim. This framework provides a formal description of the probabilistic composition of an arbitrary number of hazardous conditions and their effects on system behavior. An example is given of a probabilistic safety claim for a conflict detection algorithm for aircraft in a 2D airspace. The motivation for developing this mathematical framework is that it can be used in an automated theorem prover to formally verify safety claims.

A Baseline Patient Model to Support Testing of Medical Cyber-Physical Systems.

PubMed

Silva, Lenardo C; Perkusich, Mirko; Almeida, Hyggo O; Perkusich, Angelo; Lima, Mateus A M; Gorgônio, Kyller C

2015-01-01

Medical Cyber-Physical Systems (MCPS) are currently a trending topic of research. The main challenges are related to the integration and interoperability of connected medical devices, patient safety, physiologic closed-loop control, and the verification and validation of these systems. In this paper, we focus on patient safety and MCPS validation. We present a formal patient model to be used in health care systems validation without jeopardizing the patient's health. To determine the basic patient conditions, our model considers the four main vital signs: heart rate, respiratory rate, blood pressure and body temperature. To generate the vital signs we used regression models based on statistical analysis of a clinical database. Our solution should be used as a starting point for a behavioral patient model and adapted to specific clinical scenarios. We present the modeling process of the baseline patient model and show its evaluation. The conception process may be used to build different patient models. The results show the feasibility of the proposed model as an alternative to the immediate need for clinical trials to test these medical systems.

Proceedings of the Sixth NASA Langley Formal Methods (LFM) Workshop

NASA Technical Reports Server (NTRS)

Rozier, Kristin Yvonne (Editor)

2008-01-01

Today's verification techniques are hard-pressed to scale with the ever-increasing complexity of safety critical systems. Within the field of aeronautics alone, we find the need for verification of algorithms for separation assurance, air traffic control, auto-pilot, Unmanned Aerial Vehicles (UAVs), adaptive avionics, automated decision authority, and much more. Recent advances in formal methods have made verifying more of these problems realistic. Thus we need to continually re-assess what we can solve now and identify the next barriers to overcome. Only through an exchange of ideas between theoreticians and practitioners from academia to industry can we extend formal methods for the verification of ever more challenging problem domains. This volume contains the extended abstracts of the talks presented at LFM 2008: The Sixth NASA Langley Formal Methods Workshop held on April 30 - May 2, 2008 in Newport News, Virginia, USA. The topics of interest that were listed in the call for abstracts were: advances in formal verification techniques; formal models of distributed computing; planning and scheduling; automated air traffic management; fault tolerance; hybrid systems/hybrid automata; embedded systems; safety critical applications; safety cases; accident/safety analysis.

Formal Methods in Air Traffic Management: The Case of Unmanned Aircraft Systems

NASA Technical Reports Server (NTRS)

Munoz, Cesar A.

2015-01-01

As the technological and operational capabilities of unmanned aircraft systems (UAS) continue to grow, so too does the need to introduce these systems into civil airspace. Unmanned Aircraft Systems Integration in the National Airspace System is a NASA research project that addresses the integration of civil UAS into non-segregated airspace operations. One of the major challenges of this integration is the lack of an onboard pilot to comply with the legal requirement that pilots see and avoid other aircraft. The need to provide an equivalent to this requirement for UAS has motivated the development of a detect and avoid (DAA) capability to provide the appropriate situational awareness and maneuver guidance in avoiding and remaining well clear of traffic aircraft. Formal methods has played a fundamental role in the development of this capability. This talk reports on the formal methods work conducted under NASA's Safe Autonomous System Operations project in support of the development of DAA for UAS. This work includes specification of low-level and high-level functional requirements, formal verification of algorithms, and rigorous validation of software implementations. The talk also discusses technical challenges in formal methods research in the context of the development and safety analysis of advanced air traffic management concepts.

Proceedings of the Second NASA Formal Methods Symposium

NASA Technical Reports Server (NTRS)

Munoz, Cesar (Editor)

2010-01-01

This publication contains the proceedings of the Second NASA Formal Methods Symposium sponsored by the National Aeronautics and Space Administration and held in Washington D.C. April 13-15, 2010. Topics covered include: Decision Engines for Software Analysis using Satisfiability Modulo Theories Solvers; Verification and Validation of Flight-Critical Systems; Formal Methods at Intel -- An Overview; Automatic Review of Abstract State Machines by Meta Property Verification; Hardware-independent Proofs of Numerical Programs; Slice-based Formal Specification Measures -- Mapping Coupling and Cohesion Measures to Formal Z; How Formal Methods Impels Discovery: A Short History of an Air Traffic Management Project; A Machine-Checked Proof of A State-Space Construction Algorithm; Automated Assume-Guarantee Reasoning for Omega-Regular Systems and Specifications; Modeling Regular Replacement for String Constraint Solving; Using Integer Clocks to Verify the Timing-Sync Sensor Network Protocol; Can Regulatory Bodies Expect Efficient Help from Formal Methods?; Synthesis of Greedy Algorithms Using Dominance Relations; A New Method for Incremental Testing of Finite State Machines; Verification of Faulty Message Passing Systems with Continuous State Space in PVS; Phase Two Feasibility Study for Software Safety Requirements Analysis Using Model Checking; A Prototype Embedding of Bluespec System Verilog in the PVS Theorem Prover; SimCheck: An Expressive Type System for Simulink; Coverage Metrics for Requirements-Based Testing: Evaluation of Effectiveness; Software Model Checking of ARINC-653 Flight Code with MCP; Evaluation of a Guideline by Formal Modelling of Cruise Control System in Event-B; Formal Verification of Large Software Systems; Symbolic Computation of Strongly Connected Components Using Saturation; Towards the Formal Verification of a Distributed Real-Time Automotive System; Slicing AADL Specifications for Model Checking; Model Checking with Edge-valued Decision Diagrams; and Data-flow based Model Analysis.

A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: skin irritation.

PubMed

Macfarlane, Martin; Jones, Penny; Goebel, Carsten; Dufour, Eric; Rowland, Joanna; Araki, Daisuke; Costabel-Farkas, Margit; Hewitt, Nicola J; Hibatallah, Jalila; Kirst, Annette; McNamee, Pauline; Schellauf, Florian; Scheel, Julia

2009-07-01

Evaluation of the skin irritancy and corrosivity potential of an ingredient is a necessity in the safety assessment of cosmetic ingredients. To date, there are two formally validated alternatives to the rabbit Draize test for skin corrosivity in place, namely the rat skin transcutaneous electrical resistance (TER) assay and the Human Skin Model Test using EpiSkin, EpiDerm and SkinEthic reconstructed human epidermal equivalents. For skin irritation, EpiSkin, EpiDerm and SkinEthic are validated as stand-alone test replacements for the rabbit Draize test. Data from these tests are rarely considered in isolation and are evaluated in combination with other factors to establish the overall irritating or corrosive potential of an ingredient. In light of the deadlines established in the Cosmetics Directive for cessation of animal testing for cosmetic ingredients, a COLIPA scientific meeting was held in Brussels on 30th January, 2008 to review the use of alternative approaches and to set up a decision tree approach for their integration into tiered testing strategies for hazard and safety assessment of cosmetic ingredients and their use in products. In conclusion, the safety assessments for skin irritation/corrosion of new chemicals for use in cosmetics can be confidently accomplished using exclusively alternative methods.

Promoting Adoption of the 3Rs through Regulatory Qualification.

PubMed

Walker, Elizabeth Gribble; Baker, Amanda F; Sauer, John-Michael

2016-12-01

One mechanism to advance the application of novel safety assessment methodologies in drug development, including in silico or in vitro approaches that reduce the use of animals in toxicology studies, is regulatory qualification. Regulatory qualification, a formal process defined at the the U. S. Food and Drug Administration and the European Medicines Agency, hinges on a central concept of stating an appropriate "context of use" for a novel drug development tool (DDT) that precisely defines how that DDT can be used to support decision making in a regulated drug development setting. When accumulating the data to support a particular "context-of-use," the concept of "fit-for-purpose" often guides assay validation, as well as the type and amount of data or evidence required to evaluate the tool. This paper will review pathways for regulatory acceptance of novel DDTs and discuss examples of safety projects considered for regulatory qualification. Key concepts to be considered when defining the evidence required to formally adopt and potentially replace animal-intensive traditional safety assessment methods using qualified DDTs are proposed. Presently, the use of qualified translational kidney safety biomarkers can refine and reduce the total numbers of animals used in drug development. We propose that the same conceptual regulatory framework will be appropriate to assess readiness of new technologies that may eventually replace whole animal models. © The Author 2016. Published by Oxford University Press on behalf of the Institute for Laboratory Animal Research. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Validity of Assessment and Recognition of Non-Formal and Informal Learning Achievements in Higher Education

ERIC Educational Resources Information Center

Kaminskiene, Lina; Stasiunaitiene, Egle

2013-01-01

The article identifies the validity of assessment of non-formal and informal learning achievements (NILA) as one of the key factors for encouraging further development of the process of assessing and recognising non-formal and informal learning achievements in higher education. The authors analyse why the recognition of non-formal and informal…

Verification and Validation of Flight-Critical Systems

NASA Technical Reports Server (NTRS)

Brat, Guillaume

2010-01-01

For the first time in many years, the NASA budget presented to congress calls for a focused effort on the verification and validation (V&V) of complex systems. This is mostly motivated by the results of the VVFCS (V&V of Flight-Critical Systems) study, which should materialize as a a concrete effort under the Aviation Safety program. This talk will present the results of the study, from requirements coming out of discussions with the FAA and the Joint Planning and Development Office (JPDO) to technical plan addressing the issue, and its proposed current and future V&V research agenda, which will be addressed by NASA Ames, Langley, and Dryden as well as external partners through NASA Research Announcements (NRA) calls. This agenda calls for pushing V&V earlier in the life cycle and take advantage of formal methods to increase safety and reduce cost of V&V. I will present the on-going research work (especially the four main technical areas: Safety Assurance, Distributed Systems, Authority and Autonomy, and Software-Intensive Systems), possible extensions, and how VVFCS plans on grounding the research in realistic examples, including an intended V&V test-bench based on an Integrated Modular Avionics (IMA) architecture and hosted by Dryden.

Patient safety training in pediatric emergency medicine: a national survey of program directors.

PubMed

Wolff, Margaret; Macias, Charles G; Garcia, Estevan; Stankovic, Curt

2014-07-01

The Accreditation Council for Graduate Medical Education requires training in patient safety and medical errors but does not provide specification for content or methods. Pediatric emergency medicine (EM) fellowship directors were surveyed to characterize current training of pediatric EM fellows in patient safety and to determine the need for additional training. From June 2013 to August 2013, pediatric EM fellowship directors were surveyed via e-mail. Of the 71 eligible survey respondents, 57 (80.3%) completed surveys. A formal curriculum was present in 24.6% of programs, with a median of 6 hours (range = 1 to 18 hours) dedicated to the curriculum. One program evaluated the efficacy of the curriculum. Nearly 91% of respondents without formal programs identified lack of local faculty expertise or interest as the primary barrier to implementing patient safety curricula. Of programs without formal curricula, 93.6% included at least one component of patient safety training in their fellowship programs. The majority of respondents would implement a standardized patient safety curriculum for pediatric EM if one was available. Despite the importance of patient safety training and requirements to train pediatric EM fellows in patient safety and medical errors, there is a lack of formal curriculum and local faculty expertise. The majority of programs have introduced components of patient safety training and desire a standardized curriculum. © 2014 by the Society for Academic Emergency Medicine.

Formal Safety Certification of Aerospace Software

NASA Technical Reports Server (NTRS)

Denney, Ewen; Fischer, Bernd

2005-01-01

In principle, formal methods offer many advantages for aerospace software development: they can help to achieve ultra-high reliability, and they can be used to provide evidence of the reliability claims which can then be subjected to external scrutiny. However, despite years of research and many advances in the underlying formalisms of specification, semantics, and logic, formal methods are not much used in practice. In our opinion this is related to three major shortcomings. First, the application of formal methods is still expensive because they are labor- and knowledge-intensive. Second, they are difficult to scale up to complex systems because they are based on deep mathematical insights about the behavior of the systems (t.e., they rely on the "heroic proof"). Third, the proofs can be difficult to interpret, and typically stand in isolation from the original code. In this paper, we describe a tool for formally demonstrating safety-relevant aspects of aerospace software, which largely circumvents these problems. We focus on safely properties because it has been observed that safety violations such as out-of-bounds memory accesses or use of uninitialized variables constitute the majority of the errors found in the aerospace domain. In our approach, safety means that the program will not violate a set of rules that can range for the simple memory access rules to high-level flight rules. These different safety properties are formalized as different safety policies in Hoare logic, which are then used by a verification condition generator along with the code and logical annotations in order to derive formal safety conditions; these are then proven using an automated theorem prover. Our certification system is currently integrated into a model-based code generation toolset that generates the annotations together with the code. However, this automated formal certification technology is not exclusively constrained to our code generator and could, in principle, also be integrated with other code generators such as RealTime Workshop or even applied to legacy code. Our approach circumvents the historical problems with formal methods by increasing the degree of automation on all levels. The restriction to safety policies (as opposed to arbitrary functional behavior) results in simpler proof problems that can generally be solved by fully automatic theorem proves. An automated linking mechanism between the safety conditions and the code provides some of the traceability mandated by process standards such as DO-178B. An automated explanation mechanism uses semantic markup added by the verification condition generator to produce natural-language explanations of the safety conditions and thus supports their interpretation in relation to the code. It shows an automatically generated certification browser that lets users inspect the (generated) code along with the safety conditions (including textual explanations), and uses hyperlinks to automate tracing between the two levels. Here, the explanations reflect the logical structure of the safety obligation but the mechanism can in principle be customized using different sets of domain concepts. The interface also provides some limited control over the certification process itself. Our long-term goal is a seamless integration of certification, code generation, and manual coding that results in a "certified pipeline" in which specifications are automatically transformed into executable code, together with the supporting artifacts necessary for achieving and demonstrating the high level of assurance needed in the aerospace domain.

Formal verification and testing: An integrated approach to validating Ada programs

NASA Technical Reports Server (NTRS)

Cohen, Norman H.

1986-01-01

An integrated set of tools called a validation environment is proposed to support the validation of Ada programs by a combination of methods. A Modular Ada Validation Environment (MAVEN) is described which proposes a context in which formal verification can fit into the industrial development of Ada software.

A Formal Basis for Safety Case Patterns

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh

2013-01-01

By capturing common structures of successful arguments, safety case patterns provide an approach for reusing strategies for reasoning about safety. In the current state of the practice, patterns exist as descriptive specifications with informal semantics, which not only offer little opportunity for more sophisticated usage such as automated instantiation, composition and manipulation, but also impede standardization efforts and tool interoperability. To address these concerns, this paper gives (i) a formal definition for safety case patterns, clarifying both restrictions on the usage of multiplicity and well-founded recursion in structural abstraction, (ii) formal semantics to patterns, and (iii) a generic data model and algorithm for pattern instantiation. We illustrate our contributions by application to a new pattern, the requirements breakdown pattern, which builds upon our previous work

12th meeting of the Scientific Group on Methodologies for the Safety Evaluation of Chemicals: susceptibility to environmental hazards.

PubMed Central

Barrett, J C; Vainio, H; Peakall, D; Goldstein, B D

1997-01-01

The 12th meeting of the Scientific Group on Methodologies for the Safety Evaluation of Chemicals (SGOMSEC) considered the topic of methodologies for determining human and ecosystem susceptibility to environmental hazards. The report prepared at the meeting describes measurement of susceptibility through the use of biological markers of exposure, biological markers of effect, and biomarkers directly indicative of susceptibility of humans or of ecosystems. The utility and validity of these biological markers for the study of susceptibility are evaluated, as are opportunities for developing newer approaches for the study of humans or of ecosystems. For the first time a SGOMSEC workshop also formally considered the issue of ethics in relation to methodology, an issue of particular concern for studies of susceptibility. PMID:9255554

Safety programmes in the Egyptian construction industry.

PubMed

Hassanein, Amr A G; Hanna, Ragaa S

2007-12-01

This study is aimed at exploring the nature of the safety programmes applied by large-size contractors operating in Egypt. Results revealed that safety programmes applied by those contractors were less formal than the programmes applied by their American counterparts. Only three contractors out of the surveyed sample had accident records broken down by projects, provided workers with formal safety orientation, and trained safety personnel on first-aid. The study recommended that reforms to the scheme of the employers' contribution to social insurance are necessary. This is meant to serve as a strong incentive for safety management.

Human aspects of mission safety

NASA Technical Reports Server (NTRS)

Connors, Mary M.

1989-01-01

Recent discussions of psychology's involvement in spaceflight have emphasized its role in enhancing space living conditions and incresing crew productivity. While these goals are central to space missions, behavioral scientists should not lose sight of a more basic flight requirement - that of crew safety. This paper examines some of the processes employed in the American space program in support of crew safety and suggests that behavioral scientists could contribute to flight safety, both through these formal processes and through less formal methods. Various safety areas of relevance to behavioral scientists are discussed.

Applications of Formal Methods to Specification and Safety of Avionics Software

NASA Technical Reports Server (NTRS)

Hoover, D. N.; Guaspari, David; Humenn, Polar

1996-01-01

This report treats several topics in applications of formal methods to avionics software development. Most of these topics concern decision tables, an orderly, easy-to-understand format for formally specifying complex choices among alternative courses of action. The topics relating to decision tables include: generalizations fo decision tables that are more concise and support the use of decision tables in a refinement-based formal software development process; a formalism for systems of decision tables with behaviors; an exposition of Parnas tables for users of decision tables; and test coverage criteria and decision tables. We outline features of a revised version of ORA's decision table tool, Tablewise, which will support many of the new ideas described in this report. We also survey formal safety analysis of specifications and software.

Evidence Arguments for Using Formal Methods in Software Certification

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Pai, Ganesh

2013-01-01

We describe a generic approach for automatically integrating the output generated from a formal method/tool into a software safety assurance case, as an evidence argument, by (a) encoding the underlying reasoning as a safety case pattern, and (b) instantiating it using the data produced from the method/tool. We believe this approach not only improves the trustworthiness of the evidence generated from a formal method/tool, by explicitly presenting the reasoning and mechanisms underlying its genesis, but also provides a way to gauge the suitability of the evidence in the context of the wider assurance case. We illustrate our work by application to a real example-an unmanned aircraft system- where we invoke a formal code analysis tool from its autopilot software safety case, automatically transform the verification output into an evidence argument, and then integrate it into the former.

Alcohol addiction - the safety of available approved treatment options.

PubMed

Antonelli, Mariangela; Ferrulli, Anna; Sestito, Luisa; Vassallo, Gabriele A; Tarli, Claudia; Mosoni, Carolina; Rando, Maria M; Mirijello, Antonio; Gasbarrini, Antonio; Addolorato, Giovanni

2018-02-01

Alcohol Use Disorders (AUD) is a leading cause of mortality and morbidity worldwide. At present disulfiram, naltrexone and acamprosate are approved for the treatment of AUD in U.S. and Europe. Nalmefene is approved in Europe and sodium oxybate is approved in Italy and Austria only. Baclofen received a 'temporary recommendation for use' in France. Areas covered: The safety of the above mentioned medications on liver, digestive system, kidney function, nervous system, pregnancy and lactation and their possible side effects are described and discussed. Expert opinion: Mechanism of action and metabolism of these drugs as well as patients' clinical characteristics can affect the safety of treatment. All approved medications are valid tools for the treatment of AUD in patients without advanced liver disease. For some drugs, attention should be paid to patients with renal failure and medications may be used with caution, adjusting the dosage according to kidney function. In patients with AUD and advanced liver disease, at present only baclofen has been formally tested in randomized controlled trials showing its safety in this population.

Who is in control of road safety? A STAMP control structure analysis of the road transport system in Queensland, Australia.

PubMed

Salmon, Paul M; Read, Gemma J M; Stevens, Nicholas J

2016-11-01

Despite significant progress, road trauma continues to represent a global safety issue. In Queensland (Qld), Australia, there is currently a focus on preventing the 'fatal five' behaviours underpinning road trauma (drug and drink driving, distraction, seat belt wearing, speeding, and fatigue), along with an emphasis on a shared responsibility for road safety that spans road users, vehicle manufacturers, designers, policy makers etc. The aim of this article is to clarify who shares the responsibility for road safety in Qld and to determine what control measures are enacted to prevent the fatal five behaviours. This is achieved through the presentation of a control structure model that depicts the actors and organisations within the Qld road transport system along with the control and feedback relationships that exist between them. Validated through a Delphi study, the model shows a diverse set of actors and organisations who share the responsibility for road safety that goes beyond those discussed in road safety policies and strategies. The analysis also shows that, compared to other safety critical domains, there are less formal control structures in road transport and that opportunities exist to add new controls and strengthen existing ones. Relationships that influence rather than control are also prominent. Finally, when compared to other safety critical domains, the strength of road safety controls is brought into question. Copyright © 2016 Elsevier Ltd. All rights reserved.

ORAM-SENTINEL{trademark} demonstration at Fitzpatrick. Final report

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

Lee, L.K.; Anderson, V.M.; Mohammadi, K.

1998-06-01

New York Power Authority, in cooperation with EPRI, installed the ORAM-SENTINEL{trademark} software at James A. Fitzpatrick (JAF) Nuclear Power Plant. This software incorporates models of safety systems and support systems that are used for defense-in-depth in the plant during outage and on-line periods. A secondary goal was to include some pre-analyzed risk results to validate the methodology for quantitative assessment of the plant risks during proposed on-line maintenance. During the past year, New York Power Authority personnel have become familiar with the formal computerized Safety Assessment process associated with on-line and outage maintenance. The report describes techniques and lessons learnedmore » during development of the ORAM-SENTINEL model at JAF. It overviews the systems important to the Safety Function Assessment Process and provides details on development of the Plant Transient Assessment process using the station emergency operating procedures. The assessment results are displayed by color (green, yellow, orange, red) to show decreasing safety conditions. The report describes use of the JAF Probabilistic Safety Assessment within the ORAM-SENTINEL code to calculate an instantaneous core damage frequency and the criteria by which this frequency is translated to a color indicator.« less

Model-Driven Development of Safety Architectures

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh; Whiteside, Iain

2017-01-01

We describe the use of model-driven development for safety assurance of a pioneering NASA flight operation involving a fleet of small unmanned aircraft systems (sUAS) flying beyond visual line of sight. The central idea is to develop a safety architecture that provides the basis for risk assessment and visualization within a safety case, the formal justification of acceptable safety required by the aviation regulatory authority. A safety architecture is composed from a collection of bow tie diagrams (BTDs), a practical approach to manage safety risk by linking the identified hazards to the appropriate mitigation measures. The safety justification for a given unmanned aircraft system (UAS) operation can have many related BTDs. In practice, however, each BTD is independently developed, which poses challenges with respect to incremental development, maintaining consistency across different safety artifacts when changes occur, and in extracting and presenting stakeholder specific information relevant for decision making. We show how a safety architecture reconciles the various BTDs of a system, and, collectively, provide an overarching picture of system safety, by considering them as views of a unified model. We also show how it enables model-driven development of BTDs, replete with validations, transformations, and a range of views. Our approach, which we have implemented in our toolset, AdvoCATE, is illustrated with a running example drawn from a real UAS safety case. The models and some of the innovations described here were instrumental in successfully obtaining regulatory flight approval.

A qualitative investigation of the nature of "informal supervision" among therapists in training.

PubMed

Coren, Sidney; Farber, Barry A

2017-11-29

This study investigated how, when, why, and with whom therapists in training utilize "informal supervision"-that is, engage individuals who are not their formally assigned supervisors in significant conversations about their clinical work. Participants were 16 doctoral trainees in clinical and counseling psychology programs. Semi-structured interviews were conducted and analyzed using the Consensual Qualitative Research (CQR) method. Seven domains emerged from the analysis, indicating that, in general, participants believe that informal and formal supervision offer many of the same benefits, including validation, support, and reassurance; freedom and safety to discuss doubts, anxieties, strong personal reactions to patients, clinical mistakes and challenges; and alternative approaches to clinical interventions. However, several differences also emerged between these modes of learning-for example, formal supervision is seen as more focused on didactics per se ("what to do"), whereas informal supervision is seen as providing more of a "holding environment." Overall, the findings of this study suggest that informal supervision is an important and valuable adjunctive practice by which clinical trainees augment their professional competencies. Recommendations are proposed for clinical practice and training, including the need to further specify the ethical boundaries of this unique and essentially unregulated type of supervision.

Toward an Application Guide for Safety Integrity Level Allocation in Railway Systems.

PubMed

Ouedraogo, Kiswendsida Abel; Beugin, Julie; El-Koursi, El-Miloudi; Clarhaut, Joffrey; Renaux, Dominique; Lisiecki, Frederic

2018-02-02

The work in the article presents the development of an application guide based on feedback and comments stemming from various railway actors on their practices of SIL allocation to railway safety-related functions. The initial generic methodology for SIL allocation has been updated to be applied to railway rolling stock safety-related functions in order to solve the SIL concept application issues. Various actors dealing with railway SIL allocation problems are the intended target of the methodology; its principles will be summarized in this article with a focus on modifications and precisions made in order to establish a practical guide for railway safety authorities. The methodology is based on the flowchart formalism used in CSM (common safety method) European regulation. It starts with the use of quantitative safety requirements, particularly tolerable hazard rates (THR). THR apportioning rules are applied. On the one hand, the rules are related to classical logical combinations of safety-related functions preventing hazard occurrence. On the other hand, to take into account technical conditions (last safety weak link, functional dependencies, technological complexity, etc.), specific rules implicitly used in existing practices are defined for readjusting some THR values. SIL allocation process based on apportioned and validated THR values is finally illustrated through the example of "emergency brake" subsystems. Some specific SIL allocation rules are also defined and illustrated. © 2018 Society for Risk Analysis.

Development and validation of a new assessment tool for suturing skills in medical students.

PubMed

Sundhagen, Henriette Pisani; Almeland, Stian Kreken; Hansson, Emma

2018-01-01

In recent years, emphasis has been put on that medical student should demonstrate pre-practice/pre-registration core procedural skills to ensure patient safety. Nonetheless, the formal teaching and training of basic suturing skills to medical students have received relatively little attention and there is no standard for what should be tested and how. The aim of this study was to develop and validate, using scientific methods, a tool for assessment of medical students' suturing skills, measuring both micro- and macrosurgical qualities. A tool was constructed and content, construct, concurrent validity, and inter-rater, inter-item, inter-test reliability were tested. Three groups were included: students with no training in suturing skills, students who have had training, plastic surgery. The results show promising reliability and validity when assessing novice medical students' suturing skills. Further studies are needed on implementation of the instrument. Moreover, how the instrument can be used to give formative feedback, evaluate if a required standard is met and for curriculum development needs further investigation.Level of Evidence: Not ratable.

Formal methods and digital systems validation for airborne systems

NASA Technical Reports Server (NTRS)

Rushby, John

1993-01-01

This report has been prepared to supplement a forthcoming chapter on formal methods in the FAA Digital Systems Validation Handbook. Its purpose is as follows: to outline the technical basis for formal methods in computer science; to explain the use of formal methods in the specification and verification of software and hardware requirements, designs, and implementations; to identify the benefits, weaknesses, and difficulties in applying these methods to digital systems used on board aircraft; and to suggest factors for consideration when formal methods are offered in support of certification. These latter factors assume the context for software development and assurance described in RTCA document DO-178B, 'Software Considerations in Airborne Systems and Equipment Certification,' Dec. 1992.

Applying Formal Methods to NASA Projects: Transition from Research to Practice

NASA Technical Reports Server (NTRS)

Othon, Bill

2009-01-01

NASA project managers attempt to manage risk by relying on mature, well-understood process and technology when designing spacecraft. In the case of crewed systems, the margin for error is even tighter and leads to risk aversion. But as we look to future missions to the Moon and Mars, the complexity of the systems will increase as the spacecraft and crew work together with less reliance on Earth-based support. NASA will be forced to look for new ways to do business. Formal methods technologies can help NASA develop complex but cost effective spacecraft in many domains, including requirements and design, software development and inspection, and verification and validation of vehicle subsystems. To realize these gains, the technologies must be matured and field-tested so that they are proven when needed. During this discussion, current activities used to evaluate FM technologies for Orion spacecraft design will be reviewed. Also, suggestions will be made to demonstrate value to current designers, and mature the technology for eventual use in safety-critical NASA missions.

Synthesis from Design Requirements of a Hybrid System for Transport Aircraft Longitudinal Control. Volume 1

NASA Technical Reports Server (NTRS)

Hynes, Charles S.; Hardy, Gordon H.; Sherry, Lance

2007-01-01

Volume I of this report presents a new method for synthesizing hybrid systems directly from design requirements, and applies the method to design of a hybrid system for longitudinal control of transport aircraft. The resulting system satisfies general requirement for safety and effectiveness specified a priori, enabling formal validation to be achieved. Volume II contains seven appendices intended to make the report accessible to readers with backgrounds in human factors, fli ght dynamics and control. and formal logic. Major design goals are (1) system desi g n integrity based on proof of correctness at the design level, (2), significant simplification and cost reduction in system development and certification, and (3) improved operational efficiency, with significant alleviation of human-factors problems encountered by pilots in current transport aircraft. This report provides for the first time a firm technical basis for criteria governing design and certification of avionic systems for transport aircraft. It should be of primary interest to designers of next-generation avionic systems.

Synthesis from Design Requirements of a Hybrid System for Transport Aircraft Longitudinal Control. Volume 2

NASA Technical Reports Server (NTRS)

Hynes, Charles S.; Hardy, Gordon H.; Sherry, Lance

2007-01-01

Volume I of this report presents a new method for synthesizing hybrid systems directly from desi gn requirements, and applies the method to design of a hybrid system for longitudinal control of transport aircraft. The resulting system satisfies general requirement for safety and effectiveness specified a priori, enabling formal validation to be achieved. Volume II contains seven appendices intended to make the report accessible to readers with backgrounds in human factors, flight dynamics and control, and formal logic. Major design goals are (1) system design integrity based on proof of correctness at the design level, (2) significant simplification and cost reduction in system development and certification, and (3) improved operational efficiency, with significant alleviation of human-factors problems encountered by pilots in current transport aircraft. This report provides for the first time a firm technical basis for criteria governing design and certification of avionic systems for transport aircraft. It should be of primary interest to designers of next-generation avionic systems.

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.

A Survey of Logic Formalisms to Support Mishap Analysis

NASA Technical Reports Server (NTRS)

Johnson, Chris; Holloway, C. M.

2003-01-01

Mishap investigations provide important information about adverse events and near miss incidents. They are intended to help avoid any recurrence of previous failures. Over time, they can also yield statistical information about incident frequencies that helps to detect patterns of failure and can validate risk assessments. However, the increasing complexity of many safety critical systems is posing new challenges for mishap analysis. Similarly, the recognition that many failures have complex, systemic causes has helped to widen the scope of many mishap investigations. These two factors have combined to pose new challenges for the analysis of adverse events. A new generation of formal and semi-formal techniques have been proposed to help investigators address these problems. We introduce the term mishap logics to collectively describe these notations that might be applied to support the analysis of mishaps. The proponents of these notations have argued that they can be used to formally prove that certain events created the necessary and sufficient causes for a mishap to occur. These proofs can be used to reduce the bias that is often perceived to effect the interpretation of adverse events. Others have argued that one cannot use logic formalisms to prove causes in the same way that one might prove propositions or theorems. Such mechanisms cannot accurately capture the wealth of inductive, deductive and statistical forms of inference that investigators must use in their analysis of adverse events. This paper provides an overview of these mishap logics. It also identifies several additional classes of logic that might also be used to support mishap analysis.

Industry Strength Tool and Technology for Automated Synthesis of Safety-Critical Applications from Formal Specifications

DTIC Science & Technology

2015-11-01

28 2.3.4 Input/Output Automata ...various other modeling frameworks such as I/O Automata , Kahn Process Networks, Petri-nets, Multi-dimensional SDF, etc. are also used for designing...Formal Ideally suited to model DSP applications 3 Petri Nets Graphical Formal Used for modeling distributed systems 4 I/O Automata Both Formal

Cooperate to Validate: OBSERVAL-NET Experts' Report on Validation of Non-Formal and Informal Learning (VNIL) 2013

ERIC Educational Resources Information Center

Weber Guisan, Saskia; Voit, Janine; Lengauer, Sonja; Proinger, Eva; Duvekot, Ruud; Aagaard, Kirsten

2014-01-01

The present publication is one of the outcomes of the OBSERVAL-NET project (follow-up of the OBSERVAL project). The main aim of OBSERVAL-NET was to set up a stakeholder-centric network of organisations supporting the validation of non-formal and informal learning in Europe based on the formation of national working groups in the 8 participating…

Cooperate to Validate. Observal-Net Experts' Report on Validation of Non-Formal and Informal Learning (VNIL) 2013

ERIC Educational Resources Information Center

Weber Guisan, Saskia; Voit, Janine; Lengauer, Sonja; Proinger, Eva; Duvekot, Ruud; Aagaard, Kirsten

2014-01-01

The present publication is one of the outcomes of the OBSERVAL-NET project (followup of the OBSERVAL project). The main aim of OBSERVAL-NET was to set up a stakeholder centric network of organisations supporting the validation of non-formal and informal learning in Europe based on the formation of national working groups in the 8 participating…

AdvoCATE - User Guide

NASA Technical Reports Server (NTRS)

Denney, Ewen W.

2015-01-01

The basic vision of AdvoCATE is to automate the creation, manipulation, and management of large-scale assurance cases based on a formal theory of argument structures. Its main purposes are for creating and manipulating argument structures for safety assurance cases using the Goal Structuring Notation (GSN), and as a test bed and proof-of-concept for the formal theory of argument structures. AdvoCATE is available for Windows 7, Macintosh OSX, and Linux. Eventually, AdvoCATE will serve as a dashboard for safety related information and provide an infrastructure for safety decisions and management.

The specification-based validation of reliable multicast protocol: Problem Report. M.S. Thesis

NASA Technical Reports Server (NTRS)

Wu, Yunqing

1995-01-01

Reliable Multicast Protocol (RMP) is a communication protocol that provides an atomic, totally ordered, reliable multicast service on top of unreliable IP multicasting. In this report, we develop formal models for RMP using existing automated verification systems, and perform validation on the formal RMP specifications. The validation analysis help identifies some minor specification and design problems. We also use the formal models of RMP to generate a test suite for conformance testing of the implementation. Throughout the process of RMP development, we follow an iterative, interactive approach that emphasizes concurrent and parallel progress of implementation and verification processes. Through this approach, we incorporate formal techniques into our development process, promote a common understanding for the protocol, increase the reliability of our software, and maintain high fidelity between the specifications of RMP and its implementation.

Experiences Using Formal Methods for Requirements Modeling

NASA Technical Reports Server (NTRS)

Easterbrook, Steve; Lutz, Robyn; Covington, Rick; Kelly, John; Ampo, Yoko; Hamilton, David

1996-01-01

This paper describes three cases studies in the lightweight application of formal methods to requirements modeling for spacecraft fault protection systems. The case studies differ from previously reported applications of formal methods in that formal methods were applied very early in the requirements engineering process, to validate the evolving requirements. The results were fed back into the projects, to improve the informal specifications. For each case study, we describe what methods were applied, how they were applied, how much effort was involved, and what the findings were. In all three cases, the formal modeling provided a cost effective enhancement of the existing verification and validation processes. We conclude that the benefits gained from early modeling of unstable requirements more than outweigh the effort needed to maintain multiple representations.

Establishing the Validity of Recovery from Stuttering without Formal Treatment.

ERIC Educational Resources Information Center

Finn, Patrick

1996-01-01

This study examined a validation procedure combining self-reports with independent verification to identify cases of recovery from stuttering without formal treatment. A Speech Behavior Checklist was administered to 42 individuals familiar with recovered subjects' past speech. Analysis of subjects' descriptions of their past stuttering was…

Migration and Validation of Non-Formal and Informal Learning in Europe: Inclusion, Exclusion or Polarisation in the Recognition of Skills?

ERIC Educational Resources Information Center

Souto-Otero, Manuel; Villalba-Garcia, Ernesto

2015-01-01

This article explores (1) the degree to which immigrants can be considered dominant groups in the area of validation of non-formal and informal learning and are subject to specific validation measures in 33 European countries; (2) whether country clusters can be identified within Europe with regard to the dominance of immigrants in the area of…

Federal and tribal lands road safety audits : case studies

DOT National Transportation Integrated Search

2009-12-01

A road safety audit (RSA) is a formal safety performance examination by an independent, multidisciplinary team. RSAs are an effective tool for proactively improving the safety performance of a road project during the planning and design stages, and f...

Major accident prevention through applying safety knowledge management approach.

PubMed

Kalatpour, Omid

2016-01-01

Many scattered resources of knowledge are available to use for chemical accident prevention purposes. The common approach to management process safety, including using databases and referring to the available knowledge has some drawbacks. The main goal of this article was to devise a new emerged knowledge base (KB) for the chemical accident prevention domain. The scattered sources of safety knowledge were identified and scanned. Then, the collected knowledge was formalized through a computerized program. The Protégé software was used to formalize and represent the stored safety knowledge. The domain knowledge retrieved as well as data and information. This optimized approach improved safety and health knowledge management (KM) process and resolved some typical problems in the KM process. Upgrading the traditional resources of safety databases into the KBs can improve the interaction between the users and knowledge repository.

What is Taught on Firearm Safety in Undergraduate, Graduate, and Continuing Medical Education? A Review of Educational Programs.

PubMed

Puttagunta, R; Coverdale, T R; Coverdale, J

2016-10-01

Because there have been no published formal reviews on teaching of firearm safety, we set out to systematically locate and review the literature on curricula that educated physicians and other health care providers, residents across specialties, and medical students on how to counsel on firearm safety. We searched for all papers with outcomes that described firearm safety training programs for healthcare providers and trainees. Studies were identified through PubMed, Scopus, Google Scholar, PsychInfo, EMBASE, and MedEdPortal databases and electronically searched using combinations of words from general topic areas of firearms, learners, and education. We found four programs that met inclusion criteria. These targeted a narrow range of learners including medical students, pediatric residents, practicing pediatricians, and nurse practitioners. Teaching methods included lectures, case-based learning, group discussions, and audiotape training. There were two randomized controlled trials, one cohort design, and one posttest design. One of the randomized controlled trials was an office-based high quality multisite national study, although the focus of teaching was not on firearm safety alone. All studies used different outcomes, and only one study validated the outcome measures. There were no studies targeting psychiatrists or psychiatry residents. These results underscore a priority for developing firearm safety education programs in undergraduate, graduate, and continuing medical education settings.

Ten Commandments Revisited: A Ten-Year Perspective on the Industrial Application of Formal Methods

NASA Technical Reports Server (NTRS)

Bowen, Jonathan P.; Hinchey, Michael G.

2005-01-01

Ten years ago, our 1995 paper Ten Commandments of Formal Methods suggested some guidelines to help ensure the success of a formal methods project. It proposed ten important requirements (or "commandments") for formal developers to consider and follow, based on our knowledge of several industrial application success stories, most of which have been reported in more detail in two books. The paper was surprisingly popular, is still widely referenced, and used as required reading in a number of formal methods courses. However, not all have agreed with some of our commandments, feeling that they may not be valid in the long-term. We re-examine the original commandments ten years on, and consider their validity in the light of a further decade of industrial best practice and experiences.

Formal Logic and Flowchart for Diagnosis Validity Verification and Inclusion in Clinical Decision Support Systems

NASA Astrophysics Data System (ADS)

Sosa, M.; Grundel, L.; Simini, F.

2016-04-01

Logical reasoning is part of medical practice since its origins. Modern Medicine has included information-intensive tools to refine diagnostics and treatment protocols. We are introducing formal logic teaching in Medical School prior to Clinical Internship, to foster medical practice. Two simple examples (Acute Myocardial Infarction and Diabetes Mellitus) are given in terms of formal logic expression and truth tables. Flowcharts of both diagnostic processes help understand the procedures and to validate them logically. The particularity of medical information is that it is often accompanied by “missing data” which suggests to adapt formal logic to a “three state” logic in the future. Medical Education must include formal logic to understand complex protocols and best practices, prone to mutual interactions.

Experiences Using Lightweight Formal Methods for Requirements Modeling

NASA Technical Reports Server (NTRS)

Easterbrook, Steve; Lutz, Robyn; Covington, Rick; Kelly, John; Ampo, Yoko; Hamilton, David

1997-01-01

This paper describes three case studies in the lightweight application of formal methods to requirements modeling for spacecraft fault protection systems. The case studies differ from previously reported applications of formal methods in that formal methods were applied very early in the requirements engineering process, to validate the evolving requirements. The results were fed back into the projects, to improve the informal specifications. For each case study, we describe what methods were applied, how they were applied, how much effort was involved, and what the findings were. In all three cases, formal methods enhanced the existing verification and validation processes, by testing key properties of the evolving requirements, and helping to identify weaknesses. We conclude that the benefits gained from early modeling of unstable requirements more than outweigh the effort needed to maintain multiple representations.

Strengthening safety compliance in nuclear power operations: a role-based approach.

PubMed

Martínez-Córcoles, Mario; Gracia, Francisco J; Tomás, Inés; Peiró, José M

2014-07-01

Safety compliance is of paramount importance in guaranteeing the safe running of nuclear power plants. However, it depends mostly on procedures that do not always involve the safest outcomes. This article introduces an empirical model based on the organizational role theory to analyze the influence of legitimate sources of expectations (procedures formalization and leadership) on workers' compliance behaviors. The sample was composed of 495 employees from two Spanish nuclear power plants. Structural equation analysis showed that, in spite of some problematic effects of proceduralization (such as role conflict and role ambiguity), procedure formalization along with an empowering leadership style lead to safety compliance by clarifying a worker's role in safety. Implications of these findings for safety research are outlined, as well as their practical implications. © 2014 Society for Risk Analysis.

Recognition, Accreditation and Validation of Non-Formal and Informal Learning: Prospects for Lifelong Learning in Nepal

ERIC Educational Resources Information Center

Regmi, Kapil Dev

2009-01-01

This study was an exploration on the various issues related to recognition, accreditation and validation of non-formal and informal learning to open up avenues for lifelong learning and continuing education in Nepal. The perceptions, experiences, and opinions of Nepalese Development Activists, Educational Administrators, Policy Actors and…

Safety Verification of the Small Aircraft Transportation System Concept of Operations

NASA Technical Reports Server (NTRS)

Carreno, Victor; Munoz, Cesar

2005-01-01

A critical factor in the adoption of any new aeronautical technology or concept of operation is safety. Traditionally, safety is accomplished through a rigorous process that involves human factors, low and high fidelity simulations, and flight experiments. As this process is usually performed on final products or functional prototypes, concept modifications resulting from this process are very expensive to implement. This paper describe an approach to system safety that can take place at early stages of a concept design. It is based on a set of mathematical techniques and tools known as formal methods. In contrast to testing and simulation, formal methods provide the capability of exhaustive state exploration analysis. We present the safety analysis and verification performed for the Small Aircraft Transportation System (SATS) Concept of Operations (ConOps). The concept of operations is modeled using discrete and hybrid mathematical models. These models are then analyzed using formal methods. The objective of the analysis is to show, in a mathematical framework, that the concept of operation complies with a set of safety requirements. It is also shown that the ConOps has some desirable characteristic such as liveness and absence of dead-lock. The analysis and verification is performed in the Prototype Verification System (PVS), which is a computer based specification language and a theorem proving assistant.

Formal Verification of Complex Systems based on SysML Functional Requirements

DTIC Science & Technology

2014-12-23

Formal Verification of Complex Systems based on SysML Functional Requirements Hoda Mehrpouyan1, Irem Y. Tumer2, Chris Hoyle2, Dimitra Giannakopoulou3...requirements for design of complex engineered systems. The proposed ap- proach combines a SysML modeling approach to document and structure safety requirements...methods and tools to support the integration of safety into the design solution. 2.1. SysML for Complex Engineered Systems Traditional methods and tools

Critical Characteristics of Radiation Detection System Components to be Dedicated for use in Safety Class and Safety Significant System

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

DAVIS, S.J.

2000-05-25

This document identifies critical characteristics of components to be dedicated for use in Safety Class (SC) or Safety Significant (SS) Systems, Structures, or Components (SSCs). This document identifies the requirements for the components of the common radiation area monitor alarm in the WESF pool cell. These are procured as Commercial Grade Items (CGI), with the qualification testing and formal dedication to be performed at the Waste Encapsulation Storage Facility (WESF), in safety class, safety significant systems. System modifications are to be performed in accordance with the instructions provided on ECN 658230. Components for this change are commercially available and interchangeablemore » with the existing alarm configuration This document focuses on the operational requirements for alarm, declaration of the safety classification, identification of critical characteristics, and interpretation of requirements for procurement. Critical characteristics are identified herein and must be verified, followed by formal dedication, prior to the components being used in safety related applications.« less

ICSBEP Benchmarks For Nuclear Data Applications

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

Briggs, J. Blair

2005-05-24

The International Criticality Safety Benchmark Evaluation Project (ICSBEP) was initiated in 1992 by the United States Department of Energy. The ICSBEP became an official activity of the Organization for Economic Cooperation and Development (OECD) -- Nuclear Energy Agency (NEA) in 1995. Representatives from the United States, United Kingdom, France, Japan, the Russian Federation, Hungary, Republic of Korea, Slovenia, Serbia and Montenegro (formerly Yugoslavia), Kazakhstan, Spain, Israel, Brazil, Poland, and the Czech Republic are now participating. South Africa, India, China, and Germany are considering participation. The purpose of the ICSBEP is to identify, evaluate, verify, and formally document a comprehensive andmore » internationally peer-reviewed set of criticality safety benchmark data. The work of the ICSBEP is published as an OECD handbook entitled ''International Handbook of Evaluated Criticality Safety Benchmark Experiments.'' The 2004 Edition of the Handbook contains benchmark specifications for 3331 critical or subcritical configurations that are intended for use in validation efforts and for testing basic nuclear data. New to the 2004 Edition of the Handbook is a draft criticality alarm / shielding type benchmark that should be finalized in 2005 along with two other similar benchmarks. The Handbook is being used extensively for nuclear data testing and is expected to be a valuable resource for code and data validation and improvement efforts for decades to come. Specific benchmarks that are useful for testing structural materials such as iron, chromium, nickel, and manganese; beryllium; lead; thorium; and 238U are highlighted.« less

Towards a Formal Basis for Modular Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh

2015-01-01

Safety assurance using argument-based safety cases is an accepted best-practice in many safety-critical sectors. Goal Structuring Notation (GSN), which is widely used for presenting safety arguments graphically, provides a notion of modular arguments to support the goal of incremental certification. Despite the efforts at standardization, GSN remains an informal notation whereas the GSN standard contains appreciable ambiguity especially concerning modular extensions. This, in turn, presents challenges when developing tools and methods to intelligently manipulate modular GSN arguments. This paper develops the elements of a theory of modular safety cases, leveraging our previous work on formalizing GSN arguments. Using example argument structures we highlight some ambiguities arising through the existing guidance, present the intuition underlying the theory, clarify syntax, and address modular arguments, contracts, well-formedness and well-scopedness of modules. Based on this theory, we have a preliminary implementation of modular arguments in our toolset, AdvoCATE.

Timing of Formal Phase Safety Reviews for Large-Scale Integrated Hazard Analysis

NASA Technical Reports Server (NTRS)

Massie, Michael J.; Morris, A. Terry

2010-01-01

Integrated hazard analysis (IHA) is a process used to identify and control unacceptable risk. As such, it does not occur in a vacuum. IHA approaches must be tailored to fit the system being analyzed. Physical, resource, organizational and temporal constraints on large-scale integrated systems impose additional direct or derived requirements on the IHA. The timing and interaction between engineering and safety organizations can provide either benefits or hindrances to the overall end product. The traditional approach for formal phase safety review timing and content, which generally works well for small- to moderate-scale systems, does not work well for very large-scale integrated systems. This paper proposes a modified approach to timing and content of formal phase safety reviews for IHA. Details of the tailoring process for IHA will describe how to avoid temporary disconnects in major milestone reviews and how to maintain a cohesive end-to-end integration story particularly for systems where the integrator inherently has little to no insight into lower level systems. The proposal has the advantage of allowing the hazard analysis development process to occur as technical data normally matures.

Increasing patient safety and efficiency in transfusion therapy using formal process definitions.

PubMed

Henneman, Elizabeth A; Avrunin, George S; Clarke, Lori A; Osterweil, Leon J; Andrzejewski, Chester; Merrigan, Karen; Cobleigh, Rachel; Frederick, Kimberly; Katz-Bassett, Ethan; Henneman, Philip L

2007-01-01

The administration of blood products is a common, resource-intensive, and potentially problem-prone area that may place patients at elevated risk in the clinical setting. Much of the emphasis in transfusion safety has been targeted toward quality control measures in laboratory settings where blood products are prepared for administration as well as in automation of certain laboratory processes. In contrast, the process of transfusing blood in the clinical setting (ie, at the point of care) has essentially remained unchanged over the past several decades. Many of the currently available methods for improving the quality and safety of blood transfusions in the clinical setting rely on informal process descriptions, such as flow charts and medical algorithms, to describe medical processes. These informal descriptions, although useful in presenting an overview of standard processes, can be ambiguous or incomplete. For example, they often describe only the standard process and leave out how to handle possible failures or exceptions. One alternative to these informal descriptions is to use formal process definitions, which can serve as the basis for a variety of analyses because these formal definitions offer precision in the representation of all possible ways that a process can be carried out in both standard and exceptional situations. Formal process definitions have not previously been used to describe and improve medical processes. The use of such formal definitions to prospectively identify potential error and improve the transfusion process has not previously been reported. The purpose of this article is to introduce the concept of formally defining processes and to describe how formal definitions of blood transfusion processes can be used to detect and correct transfusion process errors in ways not currently possible using existing quality improvement methods.

Annual report to Congress. Department of Energy activities relating to the Defense Nuclear Facilities Safety Board, calendar year 2000

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

None

2001-03-01

This Annual Report to the Congress describes the Department of Energy's activities in response to formal recommendations and other interactions with the Defense Nuclear Facilities Safety Board. During 2000, the Department completed its implementation and proposed closure of one Board recommendation and completed all implementation plan milestones associated with two additional Board recommendations. Also in 2000, the Department formally accepted two new Board recommendations and developed implementation plans in response to those recommendations. The Department also made significant progress with a number of broad-based safety initiatives. These include initial implementation of integrated safety management at field sites and within headquartersmore » program offices, issuance of a nuclear safety rule, and continued progress on stabilizing excess nuclear materials to achieve significant risk reduction.« less

Software Safety Analysis of a Flight Guidance System

NASA Technical Reports Server (NTRS)

Butler, Ricky W. (Technical Monitor); Tribble, Alan C.; Miller, Steven P.; Lempia, David L.

2004-01-01

This document summarizes the safety analysis performed on a Flight Guidance System (FGS) requirements model. In particular, the safety properties desired of the FGS model are identified and the presence of the safety properties in the model is formally verified. Chapter 1 provides an introduction to the entire project, while Chapter 2 gives a brief overview of the problem domain, the nature of accidents, model based development, and the four-variable model. Chapter 3 outlines the approach. Chapter 4 presents the results of the traditional safety analysis techniques and illustrates how the hazardous conditions associated with the system trace into specific safety properties. Chapter 5 presents the results of the formal methods analysis technique model checking that was used to verify the presence of the safety properties in the requirements model. Finally, Chapter 6 summarizes the main conclusions of the study, first and foremost that model checking is a very effective verification technique to use on discrete models with reasonable state spaces. Additional supporting details are provided in the appendices.

National Survey of Neonatal Intensive Care Unit Medication Safety Practices.

PubMed

Greenberg, Rachel G; Smith, P Brian; Bose, Carl; Clark, Reese H; Cotten, C Michael; DeRienzo, Chris

2018-06-15

 We conducted a detailed survey to identify medication safety practices among a large network of United States neonatal intensive care units (NICUs).  We created a 53-question survey to assess 300 U.S. NICU's demographics, medication safety practices, adverse drug event (ADE) reporting, and ADE response plans.  Among the 164 (55%) NICUs that responded to the survey, more than 85% adhered to practices including use of electronic health records, computerized physician order entry, and clinical decision support; fewer reported adopting barcoding, formal safety surveys, and formal culture training; 137 of 164 (84%) developed at least one NICU-specific order-set with a median of 10 order-sets.  Among our survey of 164 NICUs, we found that many safety practices remain unused. Understanding safety practice variation is critical to prevent ADEs and other negative infant outcomes. Future efforts should focus on linking safety practices identified from our survey with ADEs and infant outcomes. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

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

NASA Technical Reports Server (NTRS)

Graydon, Patrick J.

2015-01-01

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

Dynamic Safety Cases for Through-Life Safety Assurance

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh; Habli, Ibrahim

2015-01-01

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

The Long Range Reconnaissance and Observation System (LORROS) with the Kollsman, Inc. Model LH-40, Infrared (Erbium) Laser Rangefinder hazard analysis and safety assessment.

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

Augustoni, Arnold L.

A laser hazard analysis and safety assessment was performed for the LH-40 IR Laser Rangefinder based on the 2000 version of the American National Standard Institute's Standard Z136.1, for the Safe Use of Lasers and Z136.6, for the Safe Use of Lasers Outdoors. The LH-40 IR Laser is central to the Long Range Reconnaissance and Observation System (LORROS). The LORROS is being evaluated by the Department 4149 Group to determine its capability as a long-range assessment tool. The manufacture lists the laser rangefinder as 'eye safe' (Class 1 laser classified under the CDRH Compliance Guide for Laser Products and 21more » CFR 1040 Laser Product Performance Standard). It was necessary that SNL validate this prior to its use involving the general public. A formal laser hazard analysis is presented for the typical mode of operation.« less

Examining Variation in Mental Models of Influence and Leadership Among Nursing Leaders and Direct Care Nurses.

PubMed

Weaver, Sallie J; Mossburg, Sarah E; Pillari, MarieSarah; Kent, Paula S; Daugherty Biddison, Elizabeth Lee

This study explored similarities and differences in the views on team membership and leadership held by nurses in formal unit leadership positions and direct care nurses. We used a mixed-methods approach and a maximum variance sampling strategy, sampling from units with both high and low safety behaviors and safety culture scores. We identified several key differences in mental models of care team membership and leadership between formal leaders and direct care nurses that warrant further exploration.

Testing First-Order Logic Axioms in AutoCert

NASA Technical Reports Server (NTRS)

Ahn, Ki Yung; Denney, Ewen

2009-01-01

AutoCert [2] is a formal verification tool for machine generated code in safety critical domains, such as aerospace control code generated from MathWorks Real-Time Workshop. AutoCert uses Automated Theorem Provers (ATPs) [5] based on First-Order Logic (FOL) to formally verify safety and functional correctness properties of the code. These ATPs try to build proofs based on user provided domain-specific axioms, which can be arbitrary First-Order Formulas (FOFs). These axioms are the most crucial part of the trusted base, since proofs can be submitted to a proof checker removing the need to trust the prover and AutoCert itself plays the part of checking the code generator. However, formulating axioms correctly (i.e. precisely as the user had really intended) is non-trivial in practice. The challenge of axiomatization arise from several dimensions. First, the domain knowledge has its own complexity. AutoCert has been used to verify mathematical requirements on navigation software that carries out various geometric coordinate transformations involving matrices and quaternions. Axiomatic theories for such constructs are complex enough that mistakes are not uncommon. Second, adjusting axioms for ATPs can add even more complexity. The axioms frequently need to be modified in order to have them in a form suitable for use with ATPs. Such modifications tend to obscure the axioms further. Thirdly, speculating validity of the axioms from the output of existing ATPs is very hard since theorem provers typically do not give any examples or counterexamples.

Patient safety culture among medical students in Singapore and Hong Kong.

PubMed

Leung, Gilberto Ka Kit; Ang, Sophia Bee Leng; Lau, Tang Ching; Neo, Hong Jye; Patil, Nivritti Gajanan; Ti, Lian Kah

2013-09-01

Undergraduate education in medical schools plays an important role in promoting patient safety. Medical students from different backgrounds may have different perceptions and attitudes toward issues concerning safety. This study aimed to investigate whether patient safety cultures differed between students from two Asian countries, and if they did, to find out how they differed. This study also aimed to identify the educational needs of these students. A voluntary, cross-sectional and self-administered questionnaire survey was conducted on 259 students from two medical schools - one in Hong Kong and the other in Singapore. None of the students had received any formal teaching on patient safety. We used a validated survey instrument, the Attitudes to Patient Safety Questionnaire III (APSQ-III), which was designed specifically for students and covered nine key factors of patient safety culture. Of the 259 students, 81 (31.3%) were from Hong Kong and 178 (68.7%) were from Singapore. The overall response rate was 66.4%. Significant differences between the two groups of students were found for two key factors - 'patient safety training', with Hong Kong students being more likely to report having received more of such training (p = 0.007); and 'error reporting confidence', which Singapore students reported having less of (p < 0.001). Both groups considered medical errors as inevitable, and that long working hours and professional incompetence were important causes of medical errors. The importance of patient involvement and team functioning were ranked relatively lower by the students. Students from different countries with no prior teaching on patient safety may differ in their baseline patient safety cultures and educational needs. Our findings serve as a reference for future longitudinal studies on the effects of different teaching and healthcare development programmes.

48 CFR 50.204 - Policy.

Code of Federal Regulations, 2011 CFR

2011-10-01

... appropriate for SAFETY Act protections and, if appropriate, formally relay this determination to DHS for purposes of supporting contractor application(s) for SAFETY Act protections in relation to criteria (b... seek SAFETY Act protections for their offered technologies, even in advance of the issuance of a...

48 CFR 50.204 - Policy.

Code of Federal Regulations, 2010 CFR

2010-10-01

... appropriate for SAFETY Act protections and, if appropriate, formally relay this determination to DHS for purposes of supporting contractor application(s) for SAFETY Act protections in relation to criteria (b... seek SAFETY Act protections for their offered technologies, even in advance of the issuance of a...

Towards an Inclusive Occupational Health and Safety For Informal Workers.

PubMed

Lund, Francie; Alfers, Laura; Santana, Vilma

2016-08-01

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

Assessing Requirements Quality through Requirements Coverage

NASA Technical Reports Server (NTRS)

Rajan, Ajitha; Heimdahl, Mats; Woodham, Kurt

2008-01-01

In model-based development, the development effort is centered around a formal description of the proposed software system the model. This model is derived from some high-level requirements describing the expected behavior of the software. For validation and verification purposes, this model can then be subjected to various types of analysis, for example, completeness and consistency analysis [6], model checking [3], theorem proving [1], and test-case generation [4, 7]. This development paradigm is making rapid inroads in certain industries, e.g., automotive, avionics, space applications, and medical technology. This shift towards model-based development naturally leads to changes in the verification and validation (V&V) process. The model validation problem determining that the model accurately captures the customer's high-level requirements has received little attention and the sufficiency of the validation activities has been largely determined through ad-hoc methods. Since the model serves as the central artifact, its correctness with respect to the users needs is absolutely crucial. In our investigation, we attempt to answer the following two questions with respect to validation (1) Are the requirements sufficiently defined for the system? and (2) How well does the model implement the behaviors specified by the requirements? The second question can be addressed using formal verification. Nevertheless, the size and complexity of many industrial systems make formal verification infeasible even if we have a formal model and formalized requirements. Thus, presently, there is no objective way of answering these two questions. To this end, we propose an approach based on testing that, when given a set of formal requirements, explores the relationship between requirements-based structural test-adequacy coverage and model-based structural test-adequacy coverage. The proposed technique uses requirements coverage metrics defined in [9] on formal high-level software requirements and existing model coverage metrics such as the Modified Condition and Decision Coverage (MC/DC) used when testing highly critical software in the avionics industry [8]. Our work is related to Chockler et al. [2], but we base our work on traditional testing techniques as opposed to verification techniques.

Policies of Adult Education in Portugal and France: The European Agenda of Validation of Non-Formal and Informal Learning

ERIC Educational Resources Information Center

Cavaco, C.; Lafont, P.; Pariat, M.

2014-01-01

This article analyses the influence of the European Union's educational policies on the implementation of devices for the recognition and the validation of informal and non-formal learning within public policies on education and training for adults in European Union Member States. Portugal and France are taken as examples. The European Union's…

Critical Characteristics of Radiation Detection System Components to be Dedicated for use in Safety Class and Safety Significant System

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

DAVIS, S.J.

2000-12-28

This document identifies critical characteristics of components to be dedicated for use in Safety Significant (SS) Systems, Structures, or Components (SSCs). This document identifies the requirements for the components of the common, radiation area, monitor alarm in the WESF pool cell. These are procured as Commercial Grade Items (CGI), with the qualification testing and formal dedication to be performed at the Waste Encapsulation Storage Facility (WESF) for use in safety significant systems. System modifications are to be performed in accordance with the approved design. Components for this change are commercially available and interchangeable with the existing alarm configuration This documentmore » focuses on the operational requirements for alarm, declaration of the safety classification, identification of critical characteristics, and interpretation of requirements for procurement. Critical characteristics are identified herein and must be verified, followed by formal dedication, prior to the components being used in safety related applications.« less

A review of research on formal reasoning and science teaching

NASA Astrophysics Data System (ADS)

Lawson, Anton E.

A central purpose of education is to improve students' reasoning abilities. The present review examines research in developmental psychology and science education that has attempted to assess the validity of Piaget's theory of formal thought and its relation to educational practice. Should a central objective of schools be to help students become formal thinkers? To answer this question research has focused on the following subordinate questions: (1) What role does biological maturation play in the development of formal reasoning? (2) Are Piaget's formal tasks reliable and valid? (3) Does formal reasoning constitute a unified and general mode of intellectual functioning? (4) How does the presence or absence of formal reasoning affect school achievement? (5) Can formal reasoning be taught? (6) What is the structural or functional nature of advanced reasoning? The general conclusion drawn is that although Piaget's work and that which has sprung from it leaves a number of unresolved theoretical and methodological problems, it provides an important background from which to make substantial progress toward a most significant educational objective.All our dignity lies in thought. By thought we must elevate ourselves, not by space and time which we can not fill. Let us endeavor then to think well; therein lies the principle of morality. Blaise Pascal 1623-1662.

Lessons in Safety: Cultural Politics and Safety Education in a Multiracial, Multiethnic Early Childhood Education Setting

ERIC Educational Resources Information Center

Saltmarsh, Sue

2010-01-01

Young children learn about safety from a variety of sources, including formal lessons and informal activities provided through early childhood education and care (ECEC) services. For many ECEC centres in Australia, scheduled visits from police and fire departments are a highlight of safety education activities. Such visits offer children the…

Expanding the Frontiers of National Qualifications Frameworks through Lifelong Learning

ERIC Educational Resources Information Center

Owusu-Agyeman, Yaw

2017-01-01

The adoption of a national qualifications framework (NQF) by some governments in all world regions has shown some success in the area of formal learning. However, while NQFs continue to enhance "formal" learning in many countries, the same cannot be said for the recognition, validation and accreditation (RVA) of "non-formal"…

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

Punnoose, Ratish J.; Armstrong, Robert C.; Wong, Matthew H.

Formal methods have come into wide use because of their effectiveness in verifying "safety and security" requirements of digital systems; a set of requirements for which testing is mostly ineffective. Formal methods are routinely used in the design and verification of high-consequence digital systems in industry. This report outlines our work in assessing the capabilities of commercial and open source formal tools and the ways in which they can be leveraged in digital design workflows.

Formal Modeling and Analysis of a Preliminary Small Aircraft Transportation System (SATS)Concept

NASA Technical Reports Server (NTRS)

Carrreno, Victor A.; Gottliebsen, Hanne; Butler, Ricky; Kalvala, Sara

2004-01-01

New concepts for automating air traffic management functions at small non-towered airports raise serious safety issues associated with the software implementations and their underlying key algorithms. The criticality of such software systems necessitates that strong guarantees of the safety be developed for them. In this paper we present a formal method for modeling and verifying such systems using the PVS theorem proving system. The method is demonstrated on a preliminary concept of operation for the Small Aircraft Transportation System (SATS) project at NASA Langley.

Formal methods and their role in digital systems validation for airborne systems

NASA Technical Reports Server (NTRS)

Rushby, John

1995-01-01

This report is based on one prepared as a chapter for the FAA Digital Systems Validation Handbook (a guide to assist FAA certification specialists with advanced technology issues). Its purpose is to explain the use of formal methods in the specification and verification of software and hardware requirements, designs, and implementations; to identify the benefits, weaknesses, and difficulties in applying these methods to digital systems used in critical applications; and to suggest factors for consideration when formal methods are offered in support of certification. The presentation concentrates on the rationale for formal methods and on their contribution to assurance for critical applications within a context such as that provided by DO-178B (the guidelines for software used on board civil aircraft); it is intended as an introduction for those to whom these topics are new.

49 CFR 209.8 - Depositions in formal proceedings.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 4 2011-10-01 2011-10-01 false Depositions in formal proceedings. 209.8 Section... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD SAFETY ENFORCEMENT PROCEDURES General § 209.8 Depositions... the testimony of any person, including a party, by deposition upon oral examination on order of the...

49 CFR 209.8 - Depositions in formal proceedings.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 4 2010-10-01 2010-10-01 false Depositions in formal proceedings. 209.8 Section... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD SAFETY ENFORCEMENT PROCEDURES General § 209.8 Depositions... the testimony of any person, including a party, by deposition upon oral examination on order of the...

Green Toxicology-Know Early About and Avoid Toxic Product Liabilities.

PubMed

Maertens, Alexandra; Hartung, Thomas

2018-02-01

Toxicology uniquely among the life sciences relies largely on methods which are more than 40-years old. Over the last 3 decades with more or less success some additions to and few replacements in this toolbox took place, mainly as alternatives to animal testing. The acceptance of such new approaches faces the needs of formal validation and the conservative attitude toward change in safety assessments. Only recently, there is growing awareness that the same alternative methods, especially in silico and in vitro tools can also much earlier and before validation inform decision-taking in the product life cycle. As similar thoughts developed in the context of Green Chemistry, the term of Green Toxicology was coined to describe this change in approach. Here, the current developments in the alternative field, especially computational and more organo-typic cell cultures are reviewed, as they lend themselves to front-loaded chemical safety assessments. The initiatives of the Center for Alternatives to Animal Testing Green Toxicology Collaboration are presented. They aim first of all for forming a community to promote this concept and then for a cultural change in companies with the necessary training of chemists, product stewards and later regulators. © The Author 2017. Published by Oxford University Press on behalf of the Society of Toxicology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

75 FR 69165 - Conductor Certification

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-10

...FRA proposes to prescribe regulations for certification of conductors, as required by the Rail Safety Improvement Act of 2008. The proposed rule would require railroads to have a formal program for certifying conductors. As part of that program, railroads would be required to have a formal process for training prospective conductors and determining that all persons are competent before permitting them to serve as a conductor. FRA is proposing this regulation to ensure that only those persons who meet minimum Federal safety standards serve as conductors, to reduce the rate and number of accidents and incidents, and to improve railroad safety. Although this NPRM does not propose any specific amendments to the regulation governing locomotive engineer certification, it does highlight areas in that regulation that may require conforming changes.

Bio-Inspired Genetic Algorithms with Formalized Crossover Operators for Robotic Applications.

PubMed

Zhang, Jie; Kang, Man; Li, Xiaojuan; Liu, Geng-Yang

2017-01-01

Genetic algorithms are widely adopted to solve optimization problems in robotic applications. In such safety-critical systems, it is vitally important to formally prove the correctness when genetic algorithms are applied. This paper focuses on formal modeling of crossover operations that are one of most important operations in genetic algorithms. Specially, we for the first time formalize crossover operations with higher-order logic based on HOL4 that is easy to be deployed with its user-friendly programing environment. With correctness-guaranteed formalized crossover operations, we can safely apply them in robotic applications. We implement our technique to solve a path planning problem using a genetic algorithm with our formalized crossover operations, and the results show the effectiveness of our technique.

Clinical Applicability and Cutoff Values for an Unstructured Neuropsychological Assessment Protocol for Older Adults with Low Formal Education

PubMed Central

de Paula, Jonas Jardim; Bertola, Laiss; Ávila, Rafaela Teixeira; Moreira, Lafaiete; Coutinho, Gabriel; de Moraes, Edgar Nunes; Bicalho, Maria Aparecida Camargos; Nicolato, Rodrigo; Diniz, Breno Satler; Malloy-Diniz, Leandro Fernandes

2013-01-01

Background and Objectives The neuropsychological exam plays a central role in the assessment of elderly patients with cognitive complaints. It is particularly relevant to differentiate patients with mild dementia from those subjects with mild cognitive impairment. Formal education is a critical factor in neuropsychological performance; however, there are few studies that evaluated the psychometric properties, especially criterion related validity, neuropsychological tests for patients with low formal education. The present study aims to investigate the validity of an unstructured neuropsychological assessment protocol for this population and develop cutoff values for clinical use. Methods and Results A protocol composed by the Rey-Auditory Verbal Learning Test, Frontal Assessment Battery, Category and Letter Fluency, Stick Design Test, Clock Drawing Test, Digit Span, Token Test and TN-LIN was administered to 274 older adults (96 normal aging, 85 mild cognitive impairment and 93 mild Alzheimer`s disease) with predominantly low formal education. Factor analysis showed a four factor structure related to Executive Functions, Language/Semantic Memory, Episodic Memory and Visuospatial Abilities, accounting for 65% of explained variance. Most of the tests showed a good sensitivity and specificity to differentiate the diagnostic groups. The neuropsychological protocol showed a significant ecological validity as 3 of the cognitive factors explained 31% of the variance on Instrumental Activities of Daily Living. Conclusion The study presents evidence of the construct, criteria and ecological validity for this protocol. The neuropsychological tests and the proposed cutoff values might be used for the clinical assessment of older adults with low formal education. PMID:24066031

Formal Methods Tool Qualification

NASA Technical Reports Server (NTRS)

Wagner, Lucas G.; Cofer, Darren; Slind, Konrad; Tinelli, Cesare; Mebsout, Alain

2017-01-01

Formal methods tools have been shown to be effective at finding defects in safety-critical digital systems including avionics systems. The publication of DO-178C and the accompanying formal methods supplement DO-333 allows applicants to obtain certification credit for the use of formal methods without providing justification for them as an alternative method. This project conducted an extensive study of existing formal methods tools, identifying obstacles to their qualification and proposing mitigations for those obstacles. Further, it interprets the qualification guidance for existing formal methods tools and provides case study examples for open source tools. This project also investigates the feasibility of verifying formal methods tools by generating proof certificates which capture proof of the formal methods tool's claim, which can be checked by an independent, proof certificate checking tool. Finally, the project investigates the feasibility of qualifying this proof certificate checker, in the DO-330 framework, in lieu of qualifying the model checker itself.

Implementation and Assessment of Food Safety Educational Materials for Secondary and Postsecondary Education

ERIC Educational Resources Information Center

Shearer, Adrienne E. H.; Snider, O. Sue; Kniel, Kalmia E.

2014-01-01

Previous studies have reported on the inadequacy of youth knowledge and practice of food safety principles. The formal high school science classroom environment presents an opportunity to stimulate interest and increase knowledge in food safety with potential benefits to students in improved science literacy, development of life skills, and…

A Formal Application of Safety and Risk Assessment in Software Systems

DTIC Science & Technology

2004-09-01

characteristics of Software Engineering, Development, and Safety...against a comparison of planned and actual schedules, costs, and characteristics . Software Safety is focused on the reduction of unsafe incidents...they merely carry out the role for which they were anatomically designed.55 Software is characteristically like an anatomical cell as it merely

Portable Wireless LAN Device and Two-Way Radio Threat Assessment for Aircraft VHF Communication Radio Band

NASA Technical Reports Server (NTRS)

Nguyen, Truong X.; Koppen, Sandra V.; Ely, Jay J.; Williams, Reuben A.; Smith, Laura J.; Salud, Maria Theresa P.

2004-01-01

This document summarizes the safety analysis performed on a Flight Guidance System (FGS) requirements model. In particular, the safety properties desired of the FGS model are identified and the presence of the safety properties in the model is formally verified. Chapter 1 provides an introduction to the entire project, while Chapter 2 gives a brief overview of the problem domain, the nature of accidents, model based development, and the four-variable model. Chapter 3 outlines the approach. Chapter 4 presents the results of the traditional safety analysis techniques and illustrates how the hazardous conditions associated with the system trace into specific safety properties. Chapter 5 presents the results of the formal methods analysis technique model checking that was used to verify the presence of the safety properties in the requirements model. Finally, Chapter 6 summarizes the main conclusions of the study, first and foremost that model checking is a very effective verification technique to use on discrete models with reasonable state spaces. Additional supporting details are provided in the appendices.

Migration and validation of non-formal and informal learning in Europe: Inclusion, exclusion or polarisation in the recognition of skills?

NASA Astrophysics Data System (ADS)

Souto-Otero, Manuel; Villalba-Garcia, Ernesto

2015-10-01

This article explores (1) the degree to which immigrants can be considered dominant groups in the area of validation of non-formal and informal learning and are subject to specific validation measures in 33 European countries; (2) whether country clusters can be identified within Europe with regard to the dominance of immigrants in the area of validation; and (3) whether validation systems are likely to lead to the inclusion of immigrants or foster a process of "devaluation" of their skills and competences in their host countries. Based on the European Inventory on validation of non- formal and informal learning project (chiefly its 2014 update) as well as a review of 124 EU-funded (Lifelong Learning Programme and European Social Fund) validation projects, the authors present the following findings: (1) in the majority of European countries, immigrants are not a dominant group in the area of validation. (2) In terms of country clusters, Central European and Nordic countries tend to consider immigrants a dominant target group for validation to a greater extent than Southern and Eastern European countries. (3) Finally, few initiatives aim to ensure that immigrants' skills and competences are not devalued in their host country, and those initiatives which are in place benefit particularly those defined as "highly skilled" individuals, on the basis of their productive potential. There is, thus, a "low road" and a "high road" to validation, leading to a process of polarisation in the recognition of the skills and competences of immigrants.

European Train Control System: A Case Study in Formal Verification

NASA Astrophysics Data System (ADS)

Platzer, André; Quesel, Jan-David

Complex physical systems have several degrees of freedom. They only work correctly when their control parameters obey corresponding constraints. Based on the informal specification of the European Train Control System (ETCS), we design a controller for its cooperation protocol. For its free parameters, we successively identify constraints that are required to ensure collision freedom. We formally prove the parameter constraints to be sharp by characterizing them equivalently in terms of reachability properties of the hybrid system dynamics. Using our deductive verification tool KeYmaera, we formally verify controllability, safety, liveness, and reactivity properties of the ETCS protocol that entail collision freedom. We prove that the ETCS protocol remains correct even in the presence of perturbation by disturbances in the dynamics. We verify that safety is preserved when a PI controlled speed supervision is used.

Patient safety in nursing education: contexts, tensions and feeling safe to learn.

PubMed

Steven, Alison; Magnusson, Carin; Smith, Pam; Pearson, Pauline H

2014-02-01

Education is crucial to how nurses practice, talk and write about keeping patients safe. The aim of this multisite study was to explore the formal and informal ways the pre-registration medical, nursing, pharmacy and physiotherapy students learn about patient safety. This paper focuses on findings from nursing. A multi-method design underpinned by the concept of knowledge contexts and illuminative evaluation was employed. Scoping of nursing curricula from four UK university programmes was followed by in-depth case studies of two programmes. Scoping involved analysing curriculum documents and interviews with 8 programme leaders. Case-study data collection included focus groups (24 students, 12 qualified nurses, 6 service users); practice placement observation (4 episodes=19 hrs) and interviews (4 Health Service managers). Within academic contexts patient safety was not visible as a curricular theme: programme leaders struggled to define it and some felt labelling to be problematic. Litigation and the risk of losing authorisation to practise were drivers to update safety in the programmes. Students reported being taught idealised skills in university with an emphasis on 'what not to do'. In organisational contexts patient safety was conceptualised as a complicated problem, addressed via strategies, systems and procedures. A tension emerged between creating a 'no blame' culture and performance management. Few formal mechanisms appeared to exist for students to learn about organisational systems and procedures. In practice, students learnt by observing staff who acted as variable role models; challenging practice was problematic, since they needed to 'fit in' and mentors were viewed as deciding whether they passed or failed their placements. The study highlights tensions both between and across contexts, which link to formal and informal patient safety education and impact negatively on students' feelings of emotional safety in their learning. Copyright © 2014 Elsevier Ltd. All rights reserved.

IEEE/NASA Workshop on Leveraging Applications of Formal Methods, Verification, and Validation

NASA Technical Reports Server (NTRS)

Margaria, Tiziana (Editor); Steffen, Bernhard (Editor); Hichey, Michael G.

2005-01-01

This volume contains the Preliminary Proceedings of the 2005 IEEE ISoLA Workshop on Leveraging Applications of Formal Methods, Verification, and Validation, with a special track on the theme of Formal Methods in Human and Robotic Space Exploration. The workshop was held on 23-24 September 2005 at the Loyola College Graduate Center, Columbia, MD, USA. The idea behind the Workshop arose from the experience and feedback of ISoLA 2004, the 1st International Symposium on Leveraging Applications of Formal Methods held in Paphos (Cyprus) last October-November. ISoLA 2004 served the need of providing a forum for developers, users, and researchers to discuss issues related to the adoption and use of rigorous tools and methods for the specification, analysis, verification, certification, construction, test, and maintenance of systems from the point of view of their different application domains.

Is there a relationship between high-quality performance in major teaching hospitals and residents' knowledge of quality and patient safety?

PubMed

Pingleton, Susan K; Horak, Bernard J; Davis, David A; Goldmann, Donald A; Keroack, Mark A; Dickler, Robert M

2009-11-01

The relationship of the quality of teaching hospitals' clinical performance to resident education in quality and patient safety is unclear. The authors studied residents' knowledge of these areas in major teaching hospitals with higher- and lower-quality performance rankings. They assessed the presence of formal and informal quality curricula to determine whether programmatic differences exist. The authors used qualitative research methodology with purposeful sampling. They gathered data from individual structured interviews with residents and key educational and quality leaders in six medical schools and teaching hospitals, which represented a range of quality performance rankings, geographic regions, and public or private status. No relationship emerged between a hospital's quality status, residents' curriculum, and the residents' understanding of quality. Residents' definitions of quality and safety and their knowledge of the practice-based learning and systems-based practice competencies were indistinguishable between hospitals. Residents in all programs had extensive patient safety knowledge acquired through an informal curriculum in the hospital setting. A formal curriculum existed in only two programs, both of them ambulatory settings. Residents' learning about quality and patient safety is extensive, largely through a positive informal curriculum in the teaching hospital and, less frequently, via a formal curriculum. No relationship was found between the quality performance of the teaching hospital and the residents' curriculum or understanding of quality or safety. Residents seem to learn through an informal curriculum provided by hospital initiatives and resources, and thus these data suggest the importance of major teaching hospitals in quality education.

A Study of the System Safety Concept as it Relates to the New Walter Reed Army Medical Center, Washington, DC.

DTIC Science & Technology

1978-03-31

established the safety level of the% * originally designed facility and the extent of current safety * modifications. The objectives evaluated the...Program could identify many safety hazards thus leading to design improvements. The study provided several recommendations to formalize the Systems Safety... design , construction, and proposed systems management of the new Walter Reed Army Medical Center (WRAMC), Washington, D.C., was conducted during the

Determining the privacy policy deficiencies of health ICT applications through semi-formal modelling.

PubMed

Croll, Peter R

2011-02-01

To ensure that patient confidentiality is securely maintained, health ICT applications that contain sensitive personal information demand comprehensive privacy policies. Determining the adequacy of these policies to meet legal conformity together with clinical users and patient expectation is demanding in practice. Organisations and agencies looking to analyse their Privacy and Security policies can benefit from guidance provided by outside entities such as the Privacy Office of their State or Government together with law firms and ICT specialists. The advice given is not uniform and often open to different interpretations. Of greater concern is the possibility of overlooking any important aspects that later result in a data breach. Based on three case studies, this paper considers whether a more formal approach to privacy analysis could be taken that would help identify the full coverage of a Privacy Impact Analysis and determine the deficiencies with an organisation's current policies and approach. A diagrammatic model showing the relationships between Confidentiality, Privacy, Trust, Security and Safety is introduced. First the validity of this model is determined by mapping it against the real-world case studies taken from three healthcare services that depend on ICT. Then, by using software engineering methods, a formal mapping of the relationships is undertaken to identify a full set of policies needed to satisfy the model. How effective this approach may prove as a generic method for deriving a comprehensive set of policies in health ICT applications is finally discussed. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

49 CFR 385.7 - Factors to be considered in determining a safety rating.

Code of Federal Regulations, 2010 CFR

2010-10-01

... information from safety reviews, compliance reviews and any other data. The factors may include all or some of... if their degree of formalization, automation, etc., is found to be substantially below the norm for...

Design of high reliability organizations in health care.

PubMed

Carroll, J S; Rudolph, J W

2006-12-01

To improve safety performance, many healthcare organizations have sought to emulate high reliability organizations from industries such as nuclear power, chemical processing, and military operations. We outline high reliability design principles for healthcare organizations including both the formal structures and the informal practices that complement those structures. A stage model of organizational structures and practices, moving from local autonomy to formal controls to open inquiry to deep self-understanding, is used to illustrate typical challenges and design possibilities at each stage. We suggest how organizations can use the concepts and examples presented to increase their capacity to self-design for safety and reliability.

Symbolic LTL Compilation for Model Checking: Extended Abstract

NASA Technical Reports Server (NTRS)

Rozier, Kristin Y.; Vardi, Moshe Y.

2007-01-01

In Linear Temporal Logic (LTL) model checking, we check LTL formulas representing desired behaviors against a formal model of the system designed to exhibit these behaviors. To accomplish this task, the LTL formulas must be translated into automata [21]. We focus on LTL compilation by investigating LTL satisfiability checking via a reduction to model checking. Having shown that symbolic LTL compilation algorithms are superior to explicit automata construction algorithms for this task [16], we concentrate here on seeking a better symbolic algorithm.We present experimental data comparing algorithmic variations such as normal forms, encoding methods, and variable ordering and examine their effects on performance metrics including processing time and scalability. Safety critical systems, such as air traffic control, life support systems, hazardous environment controls, and automotive control systems, pervade our daily lives, yet testing and simulation alone cannot adequately verify their reliability [3]. Model checking is a promising approach to formal verification for safety critical systems which involves creating a formal mathematical model of the system and translating desired safety properties into a formal specification for this model. The complement of the specification is then checked against the system model. When the model does not satisfy the specification, model-checking tools accompany this negative answer with a counterexample, which points to an inconsistency between the system and the desired behaviors and aids debugging efforts.

[Formal sample size calculation and its limited validity in animal studies of medical basic research].

PubMed

Mayer, B; Muche, R

2013-01-01

Animal studies are highly relevant for basic medical research, although their usage is discussed controversially in public. Thus, an optimal sample size for these projects should be aimed at from a biometrical point of view. Statistical sample size calculation is usually the appropriate methodology in planning medical research projects. However, required information is often not valid or only available during the course of an animal experiment. This article critically discusses the validity of formal sample size calculation for animal studies. Within the discussion, some requirements are formulated to fundamentally regulate the process of sample size determination for animal experiments.

An Interoperability Platform Enabling Reuse of Electronic Health Records for Signal Verification Studies

PubMed Central

Yuksel, Mustafa; Gonul, Suat; Laleci Erturkmen, Gokce Banu; Sinaci, Ali Anil; Invernizzi, Paolo; Facchinetti, Sara; Migliavacca, Andrea; Bergvall, Tomas; Depraetere, Kristof; De Roo, Jos

2016-01-01

Depending mostly on voluntarily sent spontaneous reports, pharmacovigilance studies are hampered by low quantity and quality of patient data. Our objective is to improve postmarket safety studies by enabling safety analysts to seamlessly access a wide range of EHR sources for collecting deidentified medical data sets of selected patient populations and tracing the reported incidents back to original EHRs. We have developed an ontological framework where EHR sources and target clinical research systems can continue using their own local data models, interfaces, and terminology systems, while structural interoperability and Semantic Interoperability are handled through rule-based reasoning on formal representations of different models and terminology systems maintained in the SALUS Semantic Resource Set. SALUS Common Information Model at the core of this set acts as the common mediator. We demonstrate the capabilities of our framework through one of the SALUS safety analysis tools, namely, the Case Series Characterization Tool, which have been deployed on top of regional EHR Data Warehouse of the Lombardy Region containing about 1 billion records from 16 million patients and validated by several pharmacovigilance researchers with real-life cases. The results confirm significant improvements in signal detection and evaluation compared to traditional methods with the missing background information. PMID:27123451

A meta-model for computer executable dynamic clinical safety checklists.

PubMed

Nan, Shan; Van Gorp, Pieter; Lu, Xudong; Kaymak, Uzay; Korsten, Hendrikus; Vdovjak, Richard; Duan, Huilong

2017-12-12

Safety checklist is a type of cognitive tool enforcing short term memory of medical workers with the purpose of reducing medical errors caused by overlook and ignorance. To facilitate the daily use of safety checklists, computerized systems embedded in the clinical workflow and adapted to patient-context are increasingly developed. However, the current hard-coded approach of implementing checklists in these systems increase the cognitive efforts of clinical experts and coding efforts for informaticists. This is due to the lack of a formal representation format that is both understandable by clinical experts and executable by computer programs. We developed a dynamic checklist meta-model with a three-step approach. Dynamic checklist modeling requirements were extracted by performing a domain analysis. Then, existing modeling approaches and tools were investigated with the purpose of reusing these languages. Finally, the meta-model was developed by eliciting domain concepts and their hierarchies. The feasibility of using the meta-model was validated by two case studies. The meta-model was mapped to specific modeling languages according to the requirements of hospitals. Using the proposed meta-model, a comprehensive coronary artery bypass graft peri-operative checklist set and a percutaneous coronary intervention peri-operative checklist set have been developed in a Dutch hospital and a Chinese hospital, respectively. The result shows that it is feasible to use the meta-model to facilitate the modeling and execution of dynamic checklists. We proposed a novel meta-model for the dynamic checklist with the purpose of facilitating creating dynamic checklists. The meta-model is a framework of reusing existing modeling languages and tools to model dynamic checklists. The feasibility of using the meta-model is validated by implementing a use case in the system.

Options for enhancing the effectiveness of Virginia's safety management system : final report.

DOT National Transportation Integrated Search

1996-02-01

In 1993, Virginia began to formalize the relationships and organizational structure for its Safety Management System (SMS). Although the SMS is no longer a federal requirement, Virginia decided to continue its implementation. The Focal Point for the ...

Safety in the Chemical Laboratory

ERIC Educational Resources Information Center

Steere, Norman V., Ed.

1974-01-01

Discusses the offering of a course in chemical and industrial hazards for junior and senior chemistry majors at City College of New York in 1972. Suggests inclusion of laboratory and industrial safety education as a formal part of chemistry or science curricula. (CC)

History of Playground Safety in America.

ERIC Educational Resources Information Center

Frost, Joe L.

The history of playground safety standards since the 1890s is reviewed and the lack of improvements in safety made since that time is demonstrated. The first formal effort to develop standards for playground apparatus was made by the National Recreation Association (NRA) in 1929. A major concern in this and a 1938 NRA report was the choice of safe…

Transformational Leaders? The Pivotal Role That Supervisors Play in Safety Culture

ERIC Educational Resources Information Center

Bahn, Susanne

2013-01-01

The purpose of this paper is to investigate the impact frontline supervisors have on workplace safety culture and to argue for increased formal supervisory training. Two studies conducted in 2006-08 and 2011 are examined and compared in which 28 Managers and Occupational Health and Safety Managers in the construction industry in Western Australia…

Availability of Neutronics Benchmarks in the ICSBEP and IRPhEP Handbooks for Computational Tools Testing

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

Bess, John D.; Briggs, J. Blair; Ivanova, Tatiana

2017-02-01

In the past several decades, numerous experiments have been performed worldwide to support reactor operations, measurements, design, and nuclear safety. Those experiments represent an extensive international investment in infrastructure, expertise, and cost, representing significantly valuable resources of data supporting past, current, and future research activities. Those valuable assets represent the basis for recording, development, and validation of our nuclear methods and integral nuclear data [1]. The loss of these experimental data, which has occurred all too much in the recent years, is tragic. The high cost to repeat many of these measurements can be prohibitive, if not impossible, to surmount.more » Two international projects were developed, and are under the direction of the Organisation for Co-operation and Development Nuclear Energy Agency (OECD NEA) to address the challenges of not just data preservation, but evaluation of the data to determine its merit for modern and future use. The International Criticality Safety Benchmark Evaluation Project (ICSBEP) was established to identify and verify comprehensive critical benchmark data sets; evaluate the data, including quantification of biases and uncertainties; compile the data and calculations in a standardized format; and formally document the effort into a single source of verified benchmark data [2]. Similarly, the International Reactor Physics Experiment Evaluation Project (IRPhEP) was established to preserve integral reactor physics experimental data, including separate or special effects data for nuclear energy and technology applications [3]. Annually, contributors from around the world continue to collaborate in the evaluation and review of select benchmark experiments for preservation and dissemination. The extensively peer-reviewed integral benchmark data can then be utilized to support nuclear design and safety analysts to validate the analytical tools, methods, and data needed for next-generation reactor design, safety analysis requirements, and all other front- and back-end activities contributing to the overall nuclear fuel cycle where quality neutronics calculations are paramount.« less

41 CFR 60-3.6 - Use of selection procedures which have not been validated.

Code of Federal Regulations, 2011 CFR

2011-07-01

... validation techniques contemplated by these guidelines. In such circumstances, the user should utilize... a formal and scored selection procedure is used which has an adverse impact, the validation... user cannot or need not follow the validation techniques anticipated by these guidelines, the user...

41 CFR 60-3.6 - Use of selection procedures which have not been validated.

Code of Federal Regulations, 2014 CFR

2014-07-01

... validation techniques contemplated by these guidelines. In such circumstances, the user should utilize... a formal and scored selection procedure is used which has an adverse impact, the validation... user cannot or need not follow the validation techniques anticipated by these guidelines, the user...

41 CFR 60-3.6 - Use of selection procedures which have not been validated.

Code of Federal Regulations, 2012 CFR

2012-07-01

... validation techniques contemplated by these guidelines. In such circumstances, the user should utilize... a formal and scored selection procedure is used which has an adverse impact, the validation... user cannot or need not follow the validation techniques anticipated by these guidelines, the user...

41 CFR 60-3.6 - Use of selection procedures which have not been validated.

Code of Federal Regulations, 2013 CFR

2013-07-01

... validation techniques contemplated by these guidelines. In such circumstances, the user should utilize... a formal and scored selection procedure is used which has an adverse impact, the validation... user cannot or need not follow the validation techniques anticipated by these guidelines, the user...

Initial validation of the International Crowding Measure in Emergency Departments (ICMED) to measure emergency department crowding.

PubMed

Boyle, Adrian; Coleman, James; Sultan, Yasmin; Dhakshinamoorthy, Vijayasankar; O'Keeffe, Jacqueline; Raut, Pramin; Beniuk, Kathleen

2015-02-01

Emergency department (ED) crowding is recognised as a major public health problem. While there is agreement that ED crowding harms patients, there is less agreement about the best way to measure ED crowding. We have previously derived an eight-point measure of ED crowding by a formal consensus process, the International Crowding Measure in Emergency Departments (ICMED). We aimed to test the feasibility of collecting this measure in real time and to partially validate this measure. We conducted a cross-sectional study in four EDs in England. We conducted independent observations of the measure and compared these with senior clinician's perceptions of crowding and safety. We obtained 84 measurements spread evenly across the four EDs. The measure was feasible to collect in real time except for the 'Left Before Being Seen' variable. Increasing numbers of violations of the measure were associated with increasing clinician concerns. The area under the receiver operating characteristic curve was 0.80 (95% CI 0.72 to 0.90) for predicting crowding and 0.74 (95% CI 0.60 to 0.89) for predicting danger. The optimal number of violations for predicting crowding was three, with a sensitivity of 91.2 (95% CI 85.1 to 97.2) and a specificity of 100.0 (92.9-100). The measure predicted clinician concerns better than individual variables such as occupancy. The ICMED can easily be collected in multiple EDs with different information technology systems. The ICMED seems to predict clinician's concerns about crowding and safety well, but future work is required to validate this before it can be advocated for widespread use. 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.

FDIR: To Increase the Reuse of the Design

NASA Astrophysics Data System (ADS)

Alison, Bernard; Parent, Loic; Provost-Grellier, Antoine; De-Ferluc, Regis

2012-08-01

The Failure Detection, Isolation and Recovery (FDIR) is a key function for the safety and the availability of a spacecraft in orbit. This function involves the totality of the avionics and the recovery efficiency directly depends on the software embedded on the On Board Computer and the Reconfiguration Module (hardware only) which is the ultimate barrier to avoid the loss of the spacecraft in case of serious failure.The design of the FDIR becomes more and more complex to fit the always more stringent requirements: to preserve the mission as long as possible to maximise the availability or to perform critical phases.In parallel with the increase of the complexity of the avionics, the failure cases and the feared events become more and more numerous. This trend leads to increase the cost and the delay of the FDIR validation.Thales Alenia Space, as satellite Prime, is aware of the problematic of the FDIR and has searched for several years solutions to formalize the design of the FDIR which is a way to enhance the reuse of the design from one mission to an other and to facilitate the validation phase.

Design of high reliability organizations in health care

PubMed Central

Carroll, J S; Rudolph, J W

2006-01-01

To improve safety performance, many healthcare organizations have sought to emulate high reliability organizations from industries such as nuclear power, chemical processing, and military operations. We outline high reliability design principles for healthcare organizations including both the formal structures and the informal practices that complement those structures. A stage model of organizational structures and practices, moving from local autonomy to formal controls to open inquiry to deep self‐understanding, is used to illustrate typical challenges and design possibilities at each stage. We suggest how organizations can use the concepts and examples presented to increase their capacity to self‐design for safety and reliability. PMID:17142607

Formal Verification of Safety Buffers for Sate-Based Conflict Detection and Resolution

NASA Technical Reports Server (NTRS)

Herencia-Zapana, Heber; Jeannin, Jean-Baptiste; Munoz, Cesar A.

2010-01-01

The information provided by global positioning systems is never totally exact, and there are always errors when measuring position and velocity of moving objects such as aircraft. This paper studies the effects of these errors in the actual separation of aircraft in the context of state-based conflict detection and resolution. Assuming that the state information is uncertain but that bounds on the errors are known, this paper provides an analytical definition of a safety buffer and sufficient conditions under which this buffer guarantees that actual conflicts are detected and solved. The results are presented as theorems, which were formally proven using a mechanical theorem prover.

Literate Specification: Using Design Rationale To Support Formal Methods in the Development of Human-Machine Interfaces.

ERIC Educational Resources Information Center

Johnson, Christopher W.

1996-01-01

The development of safety-critical systems (aircraft cockpits and reactor control rooms) is qualitatively different from that of other interactive systems. These differences impose burdens on design teams that must ensure the development of human-machine interfaces. Analyzes strengths and weaknesses of formal methods for the design of user…

29 CFR 1960.56 - Training of safety and health specialists.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., laboratory experiences, field study, and other formal learning experiences to prepare them to perform the... program development and implementation, as well as hazard recognition, evaluation and control, equipment... tasks. (b) Each agency shall implement career development programs for their occupational safety and...

INL Experimental Program Roadmap for Thermal Hydraulic Code Validation

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

Glenn McCreery; Hugh McIlroy

2007-09-01

Advanced computer modeling and simulation tools and protocols will be heavily relied on for a wide variety of system studies, engineering design activities, and other aspects of the Next Generation Nuclear Power (NGNP) Very High Temperature Reactor (VHTR), the DOE Global Nuclear Energy Partnership (GNEP), and light-water reactors. The goal is for all modeling and simulation tools to be demonstrated accurate and reliable through a formal Verification and Validation (V&V) process, especially where such tools are to be used to establish safety margins and support regulatory compliance, or to design a system in a manner that reduces the role ofmore » expensive mockups and prototypes. Recent literature identifies specific experimental principles that must be followed in order to insure that experimental data meet the standards required for a “benchmark” database. Even for well conducted experiments, missing experimental details, such as geometrical definition, data reduction procedures, and manufacturing tolerances have led to poor Benchmark calculations. The INL has a long and deep history of research in thermal hydraulics, especially in the 1960s through 1980s when many programs such as LOFT and Semiscle were devoted to light-water reactor safety research, the EBRII fast reactor was in operation, and a strong geothermal energy program was established. The past can serve as a partial guide for reinvigorating thermal hydraulic research at the laboratory. However, new research programs need to fully incorporate modern experimental methods such as measurement techniques using the latest instrumentation, computerized data reduction, and scaling methodology. The path forward for establishing experimental research for code model validation will require benchmark experiments conducted in suitable facilities located at the INL. This document describes thermal hydraulic facility requirements and candidate buildings and presents examples of suitable validation experiments related to VHTRs, sodium-cooled fast reactors, and light-water reactors. These experiments range from relatively low-cost benchtop experiments for investigating individual phenomena to large electrically-heated integral facilities for investigating reactor accidents and transients.« less

The Validation Challenge: How Close Is Europe to Recognising All Learning? Briefing Note

ERIC Educational Resources Information Center

Cedefop - European Centre for the Development of Vocational Training, 2014

2014-01-01

The European inventory on validation of non-formal and informal learning provides an unrivaled source of information detailing how validation of prior learning is developing across Europe. It shows that validation strategies and legislation, despite complexity of the task before them, have been developing slowly but steadily. However, there is…

Software Safety Progress in NASA

NASA Technical Reports Server (NTRS)

Radley, Charles F.

1995-01-01

NASA has developed guidelines for development and analysis of safety-critical software. These guidelines have been documented in a Guidebook for Safety Critical Software Development and Analysis. The guidelines represent a practical 'how to' approach, to assist software developers and safety analysts in cost effective methods for software safety. They provide guidance in the implementation of the recent NASA Software Safety Standard NSS-1740.13 which was released as 'Interim' version in June 1994, scheduled for formal adoption late 1995. This paper is a survey of the methods in general use, resulting in the NASA guidelines for safety critical software development and analysis.

76 FR 35861 - Safety Culture at the Waste Treatment and Immobilization Plant

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-20

... high. This unhealthy tension has rendered the WTP project's formal processes to resolve safety issues... Board's investigative record demonstrates that both DOE and contractor project management behaviors... allegations raised by Dr. Tamosaitis, a contractor employee removed from his position at WTP, a construction...

Building a Formal Model of a Human-Interactive System: Insights into the Integration of Formal Methods and Human Factors Engineering

NASA Technical Reports Server (NTRS)

Bolton, Matthew L.; Bass, Ellen J.

2009-01-01

Both the human factors engineering (HFE) and formal methods communities are concerned with finding and eliminating problems with safety-critical systems. This work discusses a modeling effort that leveraged methods from both fields to use model checking with HFE practices to perform formal verification of a human-interactive system. Despite the use of a seemingly simple target system, a patient controlled analgesia pump, the initial model proved to be difficult for the model checker to verify in a reasonable amount of time. This resulted in a number of model revisions that affected the HFE architectural, representativeness, and understandability goals of the effort. If formal methods are to meet the needs of the HFE community, additional modeling tools and technological developments are necessary.

A formal approach to validation and verification for knowledge-based control systems

NASA Technical Reports Server (NTRS)

Castore, Glen

1987-01-01

As control systems become more complex in response to desires for greater system flexibility, performance and reliability, the promise is held out that artificial intelligence might provide the means for building such systems. An obstacle to the use of symbolic processing constructs in this domain is the need for verification and validation (V and V) of the systems. Techniques currently in use do not seem appropriate for knowledge-based software. An outline of a formal approach to V and V for knowledge-based control systems is presented.

Formal verification of an avionics microprocessor

NASA Technical Reports Server (NTRS)

Srivas, Mandayam, K.; Miller, Steven P.

1995-01-01

Formal specification combined with mechanical verification is a promising approach for achieving the extremely high levels of assurance required of safety-critical digital systems. However, many questions remain regarding their use in practice: Can these techniques scale up to industrial systems, where are they likely to be useful, and how should industry go about incorporating them into practice? This report discusses a project undertaken to answer some of these questions, the formal verification of the AAMPS microprocessor. This project consisted of formally specifying in the PVS language a rockwell proprietary microprocessor at both the instruction-set and register-transfer levels and using the PVS theorem prover to show that the microcode correctly implemented the instruction-level specification for a representative subset of instructions. Notable aspects of this project include the use of a formal specification language by practicing hardware and software engineers, the integration of traditional inspections with formal specifications, and the use of a mechanical theorem prover to verify a portion of a commercial, pipelined microprocessor that was not explicitly designed for formal verification.

Knowledge engineering for adverse drug event prevention: on the design and development of a uniform, contextualized and sustainable knowledge-based framework.

PubMed

Koutkias, Vassilis; Kilintzis, Vassilis; Stalidis, George; Lazou, Katerina; Niès, Julie; Durand-Texte, Ludovic; McNair, Peter; Beuscart, Régis; Maglaveras, Nicos

2012-06-01

The primary aim of this work was the development of a uniform, contextualized and sustainable knowledge-based framework to support adverse drug event (ADE) prevention via Clinical Decision Support Systems (CDSSs). In this regard, the employed methodology involved first the systematic analysis and formalization of the knowledge sources elaborated in the scope of this work, through which an application-specific knowledge model has been defined. The entire framework architecture has been then specified and implemented by adopting Computer Interpretable Guidelines (CIGs) as the knowledge engineering formalism for its construction. The framework integrates diverse and dynamic knowledge sources in the form of rule-based ADE signals, all under a uniform Knowledge Base (KB) structure, according to the defined knowledge model. Equally important, it employs the means to contextualize the encapsulated knowledge, in order to provide appropriate support considering the specific local environment (hospital, medical department, language, etc.), as well as the mechanisms for knowledge querying, inference, sharing, and management. In this paper, we present thoroughly the establishment of the proposed knowledge framework by presenting the employed methodology and the results obtained as regards implementation, performance and validation aspects that highlight its applicability and virtue in medication safety. Copyright © 2012 Elsevier Inc. All rights reserved.

23 CFR 924.3 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... systems, and to exchange voice, data, or video with one another on demand, in real time, as necessary... maintained by a public authority and open to public travel. All roadway approaches must be under the... open to public travel. Road Safety Audit means a formal safety performance examination of an existing...

Food Safety Posters for Safe Handling of Leafy Greens

ERIC Educational Resources Information Center

Rajagopal, Lakshman; Arendt, Susan W.; Shaw, Angela M.; Strohbehn, Catherine H.; Sauer, Kevin L.

2016-01-01

This article describes food safety educational tools depicting safe handling of leafy greens that are available as downloadable posters to Extension educators and practitioners (www.extension.iastate.edu). Nine visual-based minimal-text colored posters in English, Chinese, and Spanish were developed for use when formally or informally educating…

Measurement tools and outcome measures used in transitional patient safety; a systematic review.

PubMed

van Melle, Marije A; van Stel, Henk F; Poldervaart, Judith M; de Wit, Niek J; Zwart, Dorien L M

2018-01-01

Patients are at risk for harm when treated simultaneously by healthcare providers from different healthcare organisations. To assess current practice and improvements of transitional patient safety, valid measurement tools are needed. To identify and appraise all measurement tools and outcomes that measure aspects of transitional patient safety, PubMed, Cinahl, Embase and Psychinfo were systematically searched. Two researchers performed the title and abstract and full-text selection. First, publications about validation of measurement tools were appraised for quality following COSMIN criteria. Second, we inventoried all measurement tools and outcome measures found in our search that assessed current transitional patient safety or the effect of interventions targeting transitional patient safety. The initial search yielded 8288 studies, of which 18 assessed validity of measurement tools of different aspects of transitional safety, and 191 assessed current transitional patient safety or effect of interventions. In the validated measurement tools, the overall quality of content and structural validity was acceptable; other COSMIN criteria, such as reliability, measurement error and responsiveness, were mostly poor or not reported. In our outcome inventory, the most frequently used validated outcome measure was the Care Transition Measure (n = 9). The most frequently used non-validated outcome measures were: medication discrepancies (n = 98), hospital readmissions (n = 55), adverse events (n = 34), emergency department visits (n = 33), (mental or physical) health status (n = 28), quality and timeliness of discharge summary, and patient satisfaction (n = 23). Although no validated measures exist that assess all aspects of transitional patient safety, we found validated measurement tools on specific aspects. Reporting of validity of transitional measurement tools was incomplete. Numerous outcome measures with unknown measurement properties are used in current studies on safety of care transitions, which makes interpretation or comparison of their results uncertain.

A Generic Software Safety Document Generator

NASA Technical Reports Server (NTRS)

Denney, Ewen; Venkatesan, Ram Prasad

2004-01-01

Formal certification is based on the idea that a mathematical proof of some property of a piece of software can be regarded as a certificate of correctness which, in principle, can be subjected to external scrutiny. In practice, however, proofs themselves are unlikely to be of much interest to engineers. Nevertheless, it is possible to use the information obtained from a mathematical analysis of software to produce a detailed textual justification of correctness. In this paper, we describe an approach to generating textual explanations from automatically generated proofs of program safety, where the proofs are of compliance with an explicit safety policy that can be varied. Key to this is tracing proof obligations back to the program, and we describe a tool which implements this to certify code auto-generated by AutoBayes and AutoFilter, program synthesis systems under development at the NASA Ames Research Center. Our approach is a step towards combining formal certification with traditional certification methods.

The Many Perspectives of Valuing Learning

ERIC Educational Resources Information Center

Duvekot, Ruud

2009-01-01

Valuing Learning is the process of promoting participation in and outcomes of (formal or non-formal) learning and as such the organising principle for lifelong learning strategies. It aims at the recognition and validation of prior learning (VPL) and further development. Four main models of Valuing Learning can be distinguished: (1) the…

A Survey of Formal Methods for Intelligent Swarms

NASA Technical Reports Server (NTRS)

Truszkowski, Walt; Rash, James; Hinchey, Mike; Rouff, Chrustopher A.

2004-01-01

Swarms of intelligent autonomous spacecraft, involving complex behaviors and interactions, are being proposed for future space exploration missions. Such missions provide greater flexibility and offer the possibility of gathering more science data than traditional single spacecraft missions. The emergent properties of swarms make these missions powerful, but simultaneously far more difficult to design, and to assure that the proper behaviors will emerge. These missions are also considerably more complex than previous types of missions, and NASA, like other organizations, has little experience in developing or in verifying and validating these types of missions. A significant challenge when verifying and validating swarms of intelligent interacting agents is how to determine that the possible exponential interactions and emergent behaviors are producing the desired results. Assuring correct behavior and interactions of swarms will be critical to mission success. The Autonomous Nano Technology Swarm (ANTS) mission is an example of one of the swarm types of missions NASA is considering. The ANTS mission will use a swarm of picospacecraft that will fly from Earth orbit to the Asteroid Belt. Using an insect colony analogy, ANTS will be composed of specialized workers for asteroid exploration. Exploration would consist of cataloguing the mass, density, morphology, and chemical composition of the asteroids, including any anomalous concentrations of specific minerals. To perform this task, ANTS would carry miniaturized instruments, such as imagers, spectrometers, and detectors. Since ANTS and other similar missions are going to consist of autonomous spacecraft that may be out of contact with the earth for extended periods of time, and have low bandwidths due to weight constraints, it will be difficult to observe improper behavior and to correct any errors after launch. Providing V&V (verification and validation) for this type of mission is new to NASA, and represents the cutting edge in system correctness, and requires higher levels of assurance than other (traditional) missions that use a single or small number of spacecraft that are deterministic in nature and have near continuous communication access. One of the highest possible levels of assurance comes from the application of formal methods. Formal methods are mathematics-based tools and techniques for specifying and verifying (software and hardware) systems. They are particularly useful for specifying complex parallel systems, such as exemplified by the ANTS mission, where the entire system is difficult for a single person to fully understand, a problem that is multiplied with multiple developers. Once written, a formal specification can be used to prove properties of a system (e.g., the underlying system will go from one state to another or not into a specific state) and check for particular types of errors (e.g., race or livelock conditions). A formal specification can also be used as input to a model checker for further validation. This report gives the results of a survey of formal methods techniques for verification and validation of space missions that use swarm technology. Multiple formal methods were evaluated to determine their effectiveness in modeling and assuring the behavior of swarms of spacecraft using the ANTS mission as an example system. This report is the first result of the project to determine formal approaches that are promising for formally specifying swarm-based systems. From this survey, the most promising approaches were selected and are discussed relative to their possible application to the ANTS mission. Future work will include the application of an integrated approach, based on the selected approaches identified in this report, to the formal specification of the ANTS mission.

Improving Safety through Human Factors Engineering.

PubMed

Siewert, Bettina; Hochman, Mary G

2015-10-01

Human factors engineering (HFE) focuses on the design and analysis of interactive systems that involve people, technical equipment, and work environment. HFE is informed by knowledge of human characteristics. It complements existing patient safety efforts by specifically taking into consideration that, as humans, frontline staff will inevitably make mistakes. Therefore, the systems with which they interact should be designed for the anticipation and mitigation of human errors. The goal of HFE is to optimize the interaction of humans with their work environment and technical equipment to maximize safety and efficiency. Special safeguards include usability testing, standardization of processes, and use of checklists and forcing functions. However, the effectiveness of the safety program and resiliency of the organization depend on timely reporting of all safety events independent of patient harm, including perceived potential risks, bad outcomes that occur even when proper protocols have been followed, and episodes of "improvisation" when formal guidelines are found not to exist. Therefore, an institution must adopt a robust culture of safety, where the focus is shifted from blaming individuals for errors to preventing future errors, and where barriers to speaking up-including barriers introduced by steep authority gradients-are minimized. This requires creation of formal guidelines to address safety concerns, establishment of unified teams with open communication and shared responsibility for patient safety, and education of managers and senior physicians to perceive the reporting of safety concerns as a benefit rather than a threat. © RSNA, 2015.

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...

78 FR 5866 - Pipeline Safety: Annual Reports and Validation

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-28

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket ID PHMSA-2012-0319] Pipeline Safety: Annual Reports and Validation AGENCY: Pipeline and Hazardous Materials... 2012 gas transmission and gathering annual reports, remind pipeline owners and operators to validate...

The pressure recovery ratio: The invasive index of LV relaxation during filling. Model-based prediction with in-vivo validation.

PubMed

Zhang, Wei; Shmuylovich, Leonid; Kovacs, Sandor J

2009-01-01

Using a simple harmonic oscillator model (PDF formalism), every early filling E-wave can be uniquely described by a set of parameters, (x(0), c, and k). Parameter c in the PDF formalism is a damping or relaxation parameter that measures the energy loss during the filling process. Based on Bernoulli's equation and kinematic modeling, we derived a causal correlation between the relaxation parameter c in the PDF formalism and a feature of the pressure contour during filling - the pressure recovery ratio defined by the left ventricular pressure difference between diastasis and minimum pressure, normalized to the pressure difference between a fiducial pressure and minimum pressure [PRR = (P(Diastasis)-P(Min))/(P(Fiducial)-P(Min))]. We analyzed multiple heart beats from one human subject to validate the correlation. Further validation among more patients is warranted. PRR is the invasive causal analogue of the noninvasive E-wave relaxation parameter c. PRR has the potential to be calculated using automated methodology in the catheterization lab in real time.

Development and Validation of a Safety Climate Scale for Manufacturing Industry

PubMed Central

Ghahramani, Abolfazl; Khalkhali, Hamid R.

2015-01-01

Background This paper describes the development of a scale for measuring safety climate. Methods This study was conducted in six manufacturing companies in Iran. The scale developed through conducting a literature review about the safety climate and constructing a question pool. The number of items was reduced to 71 after performing a screening process. Results The result of content validity analysis showed that 59 items had excellent item content validity index (≥ 0.78) and content validity ratio (> 0.38). The exploratory factor analysis resulted in eight safety climate dimensions. The reliability value for the final 45-item scale was 0.96. The result of confirmatory factor analysis showed that the safety climate model is satisfactory. Conclusion This study produced a valid and reliable scale for measuring safety climate in manufacturing companies. PMID:26106508

A Tool for Requirements-Based Programming

NASA Technical Reports Server (NTRS)

Rash, James L.; Hinchey, Michael G.; Rouff, Christopher A.; Gracanin, Denis; Erickson, John

2005-01-01

Absent a general method for mathematically sound, automated transformation of customer requirements into a formal model of the desired system, developers must resort to either manual application of formal methods or to system testing (either manual or automated). While formal methods have afforded numerous successes, they present serious issues, e.g., costs to gear up to apply them (time, expensive staff), and scalability and reproducibility when standards in the field are not settled. The testing path cannot be walked to the ultimate goal, because exhaustive testing is infeasible for all but trivial systems. So system verification remains problematic. System or requirements validation is similarly problematic. The alternatives available today depend on either having a formal model or pursuing enough testing to enable the customer to be certain that system behavior meets requirements. The testing alternative for non-trivial systems always have some system behaviors unconfirmed and therefore is not the answer. To ensure that a formal model is equivalent to the customer s requirements necessitates that the customer somehow fully understands the formal model, which is not realistic. The predominant view that provably correct system development depends on having a formal model of the system leads to a desire for a mathematically sound method to automate the transformation of customer requirements into a formal model. Such a method, an augmentation of requirements-based programming, will be briefly described in this paper, and a prototype tool to support it will be described. The method and tool enable both requirements validation and system verification for the class of systems whose behavior can be described as scenarios. An application of the tool to a prototype automated ground control system for NASA mission is presented.

Using formal methods for content validation of medical procedure documents.

PubMed

Cota, Érika; Ribeiro, Leila; Bezerra, Jonas Santos; Costa, Andrei; da Silva, Rosiana Estefane; Cota, Gláucia

2017-08-01

We propose the use of a formal approach to support content validation of a standard operating procedure (SOP) for a therapeutic intervention. Such an approach provides a useful tool to identify ambiguities, omissions and inconsistencies, and improves the applicability and efficacy of documents in the health settings. We apply and evaluate a methodology originally proposed for the verification of software specification documents to a specific SOP. The verification methodology uses the graph formalism to model the document. Semi-automatic analysis identifies possible problems in the model and in the original document. The verification is an iterative process that identifies possible faults in the original text that should be revised by its authors and/or specialists. The proposed method was able to identify 23 possible issues in the original document (ambiguities, omissions, redundant information, and inaccuracies, among others). The formal verification process aided the specialists to consider a wider range of usage scenarios and to identify which instructions form the kernel of the proposed SOP and which ones represent additional or required knowledge that are mandatory for the correct application of the medical document. By using the proposed verification process, a simpler and yet more complete SOP could be produced. As consequence, during the validation process the experts received a more mature document and could focus on the technical aspects of the procedure itself. Copyright © 2017 Elsevier B.V. All rights reserved.

Cost model validation: a technical and cultural approach

NASA Technical Reports Server (NTRS)

Hihn, J.; Rosenberg, L.; Roust, K.; Warfield, K.

2001-01-01

This paper summarizes how JPL's parametric mission cost model (PMCM) has been validated using both formal statistical methods and a variety of peer and management reviews in order to establish organizational acceptance of the cost model estimates.

Validation of Safety-Critical Systems for Aircraft Loss-of-Control Prevention and Recovery

NASA Technical Reports Server (NTRS)

Belcastro, Christine M.

2012-01-01

Validation of technologies developed for loss of control (LOC) prevention and recovery poses significant challenges. Aircraft LOC can result from a wide spectrum of hazards, often occurring in combination, which cannot be fully replicated during evaluation. Technologies developed for LOC prevention and recovery must therefore be effective under a wide variety of hazardous and uncertain conditions, and the validation framework must provide some measure of assurance that the new vehicle safety technologies do no harm (i.e., that they themselves do not introduce new safety risks). This paper summarizes a proposed validation framework for safety-critical systems, provides an overview of validation methods and tools developed by NASA to date within the Vehicle Systems Safety Project, and develops a preliminary set of test scenarios for the validation of technologies for LOC prevention and recovery

Nuclear criticality safety staff training and qualifications at Los Alamos National Laboratory

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

Monahan, S.P.; McLaughlin, T.P.

1997-05-01

Operations involving significant quantities of fissile material have been conducted at Los Alamos National Laboratory continuously since 1943. Until the advent of the Laboratory`s Nuclear Criticality Safety Committee (NCSC) in 1957, line management had sole responsibility for controlling criticality risks. From 1957 until 1961, the NCSC was the Laboratory body which promulgated policy guidance as well as some technical guidance for specific operations. In 1961 the Laboratory created the position of Nuclear Criticality Safety Office (in addition to the NCSC). In 1980, Laboratory management moved the Criticality Safety Officer (and one other LACEF staff member who, by that time, wasmore » also working nearly full-time on criticality safety issues) into the Health Division office. Later that same year the Criticality Safety Group, H-6 (at that time) was created within H-Division, and staffed by these two individuals. The training and education of these individuals in the art of criticality safety was almost entirely self-regulated, depending heavily on technical interactions between each other, as well as NCSC, LACEF, operations, other facility, and broader criticality safety community personnel. Although the Los Alamos criticality safety group has grown both in size and formality of operations since 1980, the basic philosophy that a criticality specialist must be developed through mentoring and self motivation remains the same. Formally, this philosophy has been captured in an internal policy, document ``Conduct of Business in the Nuclear Criticality Safety Group.`` There are no short cuts or substitutes in the development of a criticality safety specialist. A person must have a self-motivated personality, excellent communications skills, a thorough understanding of the principals of neutron physics, a safety-conscious and helpful attitude, a good perspective of real risk, as well as a detailed understanding of process operations and credible upsets.« less

38 CFR 17.155 - Minimum standards of safety and quality for automotive adaptive equipment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... justify development of formal standards, such equipment will be inspected and, if in order, approved for... safety and quality for automotive adaptive equipment. 17.155 Section 17.155 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS MEDICAL Automotive Equipment and Driver Training § 17.155...

The Personnel Effectiveness Grid (PEG): A New Tool for Estimating Personnel Department Effectiveness

ERIC Educational Resources Information Center

Petersen, Donald J.; Malone, Robert L.

1975-01-01

Examines the difficulties inherent in attempting a formal personnel evaluation system, the major formal methods currently used for evaluating personnel department accountabilities, some parameters that should be part of a valid evaluation program, and a model for conducting the evaluation. (Available from Office of Publications, Graduate School of…

Peer Review of a Formal Verification/Design Proof Methodology

NASA Technical Reports Server (NTRS)

1983-01-01

The role of formal verification techniques in system validation was examined. The value and the state of the art of performance proving for fault-tolerant compuers were assessed. The investigation, development, and evaluation of performance proving tools were reviewed. The technical issues related to proof methodologies are examined. The technical issues discussed are summarized.

Report on the formal specification and partial verification of the VIPER microprocessor

NASA Technical Reports Server (NTRS)

Brock, Bishop; Hunt, Warren A., Jr.

1991-01-01

The formal specification and partial verification of the VIPER microprocessor is reviewed. The VIPER microprocessor was designed by RSRE, Malvern, England, for safety critical computing applications (e.g., aircraft, reactor control, medical instruments, armaments). The VIPER was carefully specified and partially verified in an attempt to provide a microprocessor with completely predictable operating characteristics. The specification of VIPER is divided into several levels of abstraction, from a gate-level description up to an instruction execution model. Although the consistency between certain levels was demonstrated with mechanically-assisted mathematical proof, the formal verification of VIPER was never completed.

Review of Estelle and LOTOS with respect to critical computer applications

NASA Technical Reports Server (NTRS)

Bown, Rodney L.

1991-01-01

Man rated NASA space vehicles seem to represent a set of ultimate critical computer applications. These applications require a high degree of security, integrity, and safety. A variety of formal and/or precise modeling techniques are becoming available for the designer of critical systems. The design phase of the software engineering life cycle includes the modification of non-development components. A review of the Estelle and LOTOS formal description languages is presented. Details of the languages and a set of references are provided. The languages were used to formally describe some of the Open System Interconnect (OSI) protocols.

Initial Steps in Creating a Developmentally Valid Tool for Observing/Assessing Rope Jumping

ERIC Educational Resources Information Center

Roberton, Mary Ann; Thompson, Gregory; Langendorfer, Stephen J.

2017-01-01

Background: Valid motor development sequences show the various behaviors that children display as they progress toward competence in specific motor skills. Teachers can use these sequences to observe informally or formally assess their students. While longitudinal study is ultimately required to validate developmental sequences, there are earlier,…

Behavioral health screening and intervention for women in Argentina: a preliminary model for the childbearing years

PubMed Central

Suarez Ordoñez, Rocio M; Cesolari, Jorgelina; Ofelia, Casas; Villavicencio, Ivonne; Jones, Hendrée E

2015-01-01

Untreated behavioral disorders in pregnant women and in women of childbearing age pose physical and psychological safety concerns and are barriers to the well-being of both mother and neonate. The present paper underlines the importance of screening in Argentina for behavioral problems in women of childbearing age, particularly pregnant women and their newborns. Emphasized is the need to formalize this comprehensive screening in a protocol that includes domains of mental disorders, behavioral disorders, education, social environment, employment, desire for maternity, substance use including non-prescription use of prescription medications, eating disorders, suicide risk, interpersonal violence, stress, and trauma. Implementation of such a model would require agreement and cooperation between the public and private health sectors as well as in the development of research for validation of the various screening and interventions tools that would be adopted for general use. PMID:26203284

Implications of pharmacogenomics for drug development and clinical practice.

PubMed

Ginsburg, Geoffrey S; Konstance, Richard P; Allsbrook, Jennifer S; Schulman, Kevin A

2005-11-14

Pharmacogenomics is likely to be among the first clinical applications of the Human Genome Project and is certain to have an enormous impact on the clinical practice of medicine. Herein, we discuss the potential implications of pharmacogenomics on the drug development process, including drug safety, productivity, market segmentation, market expansion, differentiation, and personalized health care. We also review 3 challenges facing the translation of pharmacogenomics into clinical practice: dependence on information technology, limited health care financing, and the scientific uncertainty surrounding validation of specific applications of the technology. To our knowledge, there is currently no formal agenda to promote and cultivate innovation, to develop progressive information technology, or to obtain the financing that would be required to advance the use of pharmacogenomic technologies in patient care. Although the potential of these technologies is driving change in the development of clinical sciences, it remains to be seen which health care systems level needs will be addressed.

Towards Formal Implementation of PUS Standard

NASA Astrophysics Data System (ADS)

Ilić, D.

2009-05-01

As an effort to promote the reuse of on-board and ground systems ESA developed a standard for packet telemetry and telecommand - PUS. It defines a set of standard service models with the corresponding structures of the associated telemetry and telecommand packets. Various missions then can choose to implement those standard PUS services that best conform to their specific requirements. In this paper we propose a formal development (based on the Event-B method) of reusable service patterns, which can be instantiated for concrete application. Our formal models allow us to formally express and verify specific service properties including various telecommand and telemetry packet structure validation.

LinkEHR-Ed: a multi-reference model archetype editor based on formal semantics.

PubMed

Maldonado, José A; Moner, David; Boscá, Diego; Fernández-Breis, Jesualdo T; Angulo, Carlos; Robles, Montserrat

2009-08-01

To develop a powerful archetype editing framework capable of handling multiple reference models and oriented towards the semantic description and standardization of legacy data. The main prerequisite for implementing tools providing enhanced support for archetypes is the clear specification of archetype semantics. We propose a formalization of the definition section of archetypes based on types over tree-structured data. It covers the specialization of archetypes, the relationship between reference models and archetypes and conformance of data instances to archetypes. LinkEHR-Ed, a visual archetype editor based on the former formalization with advanced processing capabilities that supports multiple reference models, the editing and semantic validation of archetypes, the specification of mappings to data sources, and the automatic generation of data transformation scripts, is developed. LinkEHR-Ed is a useful tool for building, processing and validating archetypes based on any reference model.

Formal Methods for Automated Diagnosis of Autosub 6000

NASA Technical Reports Server (NTRS)

Ernits, Juhan; Dearden, Richard; Pebody, Miles

2009-01-01

This is a progress report on applying formal methods in the context of building an automated diagnosis and recovery system for Autosub 6000, an Autonomous Underwater Vehicle (AUV). The diagnosis task involves building abstract models of the control system of the AUV. The diagnosis engine is based on Livingstone 2, a model-based diagnoser originally built for aerospace applications. Large parts of the diagnosis model can be built without concrete knowledge about each mission, but actual mission scripts and configuration parameters that carry important information for diagnosis are changed for every mission. Thus we use formal methods for generating the mission control part of the diagnosis model automatically from the mission script and perform a number of invariant checks to validate the configuration. After the diagnosis model is augmented with the generated mission control component model, it needs to be validated using verification techniques.

Older adults' preferences for formal social support of autonomy and dependence in pain: development and validation of a scale.

PubMed

Bernardes, Sónia F; Matos, Marta; Goubert, Liesbet

2017-09-01

Chronic pain among older adults is common and often disabling. Pain-related formal social support (e.g., provided by staff at day-care centers, nursing homes), and the extent to which it promotes functional autonomy or dependence, plays a significant role in the promotion of older adults' ability to engage in their daily activities. Assessing older adults' preferences for pain-related social support for functional autonomy or dependence could contribute to increase formal social support responsiveness to individuals' needs. Therefore, this study aimed at developing and validating the preferences for formal social support of autonomy and dependence in pain inventory (PFSSADI). One hundred and sixty-five older adults with chronic musculoskeletal pain ( M age  = 79.1, 67.3% women), attending day-care centers, completed the PFSSADI, the revised formal social support for autonomy and dependence in pain inventory, and a measure of desire for (in)dependence; the PFSSADI was filled out again 6 weeks later. Confirmatory factor analyses showed a structure of two correlated factors ( r  = .56): (a) preferences for autonomy support ( α  = .99) and (b) preferences for dependence support ( α  = .98). The scale showed good test-retest reliability, sensitivity and discriminant and concurrent validity; the higher the preferences for dependence support, the higher the desire for dependence ( r  = .33) and the lower the desire for independence ( r  = -.41). The PFSSADI is an innovative tool, which may contribute to explore the role of pain-related social support responsiveness on the promotion of older adults' functional autonomy when in pain.

Assessing the reliability and validity of direct observation and traffic camera streams to measure helmet and motorcycle use.

PubMed

Zaccaro, Heather N; Carbone, Emily C; Dsouza, Nishita; Xu, Michelle R; Byrne, Mary C; Kraemer, John D

2015-12-01

There is a need to develop motorcycle helmet surveillance approaches that are less labour intensive than direct observation (DO), which is the commonly recommended but never formally validated approach, particularly in developing settings. This study sought to assess public traffic camera feeds as an alternative to DO, in addition to the reliability of DO under field conditions. DO had high inter-rater reliability, κ=0.88 and 0.84, respectively, for cycle type and helmet type, which reinforces its use as a gold standard. However, traffic camera-based data collection was found to be unreliable, with κ=0.46 and 0.53 for cycle type and helmet type. When bicycles, motorcycles and scooters were classified based on traffic camera streams, only 68.4% of classifications concurred with those made via DO. Given the current technology, helmet surveillance via traffic camera streams is infeasible, and there remains a need for innovative traffic safety surveillance approaches in low-income urban settings. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Improving operating room safety

PubMed Central

2009-01-01

Despite the introduction of the Universal Protocol, patient safety in surgery remains a daily challenge in the operating room. This present study describes one community health system's efforts to improve operating room safety through human factors training and ultimately the development of a surgical checklist. Using a combination of formal training, local studies documenting operating room safety issues and peer to peer mentoring we were able to substantially change the culture of our operating room. Our efforts have prepared us for successfully implementing a standardized checklist to improve operating room safety throughout our entire system. Based on these findings we recommend a multimodal approach to improving operating room safety. PMID:19930577

Procedural, Educational and Caring Aspects of Nursing and Health Care Technology.

ERIC Educational Resources Information Center

Abbey, June C.

Nurses are prime users of medical devices in patient care and must be aware of four safety issues: safety of the patient, the information, the personnel, and the device. Thus, nurses need to be able to understand and communicate in the language of technological devices. With formal coursework in the use of instruments being limited, agency…

Properties of a Formal Method for Prediction of Emergent Behaviors in Swarm-based Systems

NASA Technical Reports Server (NTRS)

Rouff, Christopher; Vanderbilt, Amy; Hinchey, Mike; Truszkowski, Walt; Rash, James

2004-01-01

Autonomous intelligent swarms of satellites are being proposed for NASA missions that have complex behaviors and interactions. The emergent properties of swarms make these missions powerful, but at the same time more difficult to design and assure that proper behaviors will emerge. This paper gives the results of research into formal methods techniques for verification and validation of NASA swarm-based missions. Multiple formal methods were evaluated to determine their effectiveness in modeling and assuring the behavior of swarms of spacecraft. The NASA ANTS mission was used as an example of swarm intelligence for which to apply the formal methods. This paper will give the evaluation of these formal methods and give partial specifications of the ANTS mission using four selected methods. We then give an evaluation of the methods and the needed properties of a formal method for effective specification and prediction of emergent behavior in swarm-based systems.

Safety of High Speed Ground Transportation Systems : Analytical Methodology for Safety Validation of Computer Controlled Subsystems : Volume 2. Development of a Safety Validation Methodology

DOT National Transportation Integrated Search

1995-01-01

This report describes the development of a methodology designed to assure that a sufficiently high level of safety is achieved and maintained in computer-based systems which perform safety cortical functions in high-speed rail or magnetic levitation ...

46 CFR 71.75-13 - Safety Management Certificate.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 3 2010-10-01 2010-10-01 false Safety Management Certificate. 71.75-13 Section 71.75-13... CERTIFICATION Certificates Under the International Convention for Safety of Life at Sea, 1960 § 71.75-13 Safety... valid Safety Management Certificate and a copy of their company's valid Document of Compliance...

Open systems & non-formal education

NASA Astrophysics Data System (ADS)

Wheeler, Gerald F.

1988-10-01

Professor Dib created an important structure that can be used to attach the many and various activities that fall in the category of this title. While I plan to use his structure, I will be emphasizing a different component of his spectrum and promoting a different need. Professor Dib suggested a critical need to move our teaching styles away from formal modes to non-formal modes of delivery. I suggest an equally critical need in the area of informal education. And, I will propose aways to move us toward the same goal, non-formal activities. I believe we need to find ways to use the many informal education activities that occur almost automatically in our societies to move our potential learners to richer non-formal endeavors. Both needs are real; both activities are valid.

Formal testing and utilization of streaming media to improve flight crew safety knowledge.

PubMed

Bellazzini, Marc A; Rankin, Peter M; Quisling, Jason; Gangnon, Ronald; Kohrs, Mike

2008-01-01

Increased concerns over the safety of air medical transport have prompted development of novel ways to increase safety. The objective of our study was to determine if an Internet streaming media safety video increased crew safety knowledge. 23 out of 40 crew members took an online safety pre-test, watched a safety video specific to our program and completed immediate and long-term post-testing 6 months later. Mean pre-test, post-test and 6 month follow up test scores were 84.9%, 92.3% and 88.4% respectively. There was a statistically significant difference in all scores (p

Formal Verification of the AAMP-FV Microcode

NASA Technical Reports Server (NTRS)

Miller, Steven P.; Greve, David A.; Wilding, Matthew M.; Srivas, Mandayam

1999-01-01

This report describes the experiences of Collins Avionics & Communications and SRI International in formally specifying and verifying the microcode in a Rockwell proprietary microprocessor, the AAMP-FV, using the PVS verification system. This project built extensively on earlier experiences using PVS to verify the microcode in the AAMP5, a complex, pipelined microprocessor designed for use in avionics displays and global positioning systems. While the AAMP5 experiment demonstrated the technical feasibility of formal verification of microcode, the steep learning curve encountered left unanswered the question of whether it could be performed at reasonable cost. The AAMP-FV project was conducted to determine whether the experience gained on the AAMP5 project could be used to make formal verification of microcode cost effective for safety-critical and high volume devices.

Tree-oriented interactive processing with an application to theorem-proving, appendix E

NASA Technical Reports Server (NTRS)

Hammerslag, David; Kamin, Samuel N.; Campbell, Roy H.

1985-01-01

The concept of unstructured structure editing and ted, an editor for unstructured trees, is described. Ted is used to manipulate hierarchies of information in an unrestricted manner. The tool was implemented and applied to the problem of organizing formal proofs. As a proof management tool, it maintains the validity of a proof and its constituent lemmas independently from the methods used to validate the proof. It includes an adaptable interface which may be used to invoke theorem provers and other aids to proof construction. Using ted, a user may construct, maintain, and verify formal proofs using a variety of theorem provers, proof checkers, and formatters.

Validation of Resource Utilization Groups version III for Home Care (RUG-III/HC): evidence from a Canadian home care jurisdiction.

PubMed

Poss, Jeffrey W; Hirdes, John P; Fries, Brant E; McKillop, Ian; Chase, Mary

2008-04-01

The case-mix system Resource Utilization Groups version III for Home Care (RUG-III/HC) was derived using a modest data sample from Michigan, but to date no comprehensive large scale validation has been done. This work examines the performance of the RUG-III/HC classification using a large sample from Ontario, Canada. Cost episodes over a 13-week period were aggregated from individual level client billing records and matched to assessment information collected using the Resident Assessment Instrument for Home Care, from which classification rules for RUG-III/HC are drawn. The dependent variable, service cost, was constructed using formal services plus informal care valued at approximately one-half that of a replacement worker. An analytic dataset of 29,921 episodes showed a skewed distribution with over 56% of cases falling into the lowest hierarchical level, reduced physical functions. Case-mix index values for formal and informal cost showed very close similarities to those found in the Michigan derivation. Explained variance for a function of combined formal and informal cost was 37.3% (20.5% for formal cost alone), with personal support services as well as informal care showing the strongest fit to the RUG-III/HC classification. RUG-III/HC validates well compared with the Michigan derivation work. Potential enhancements to the present classification should consider the large numbers of undifferentiated cases in the reduced physical function group, and the low explained variance for professional disciplines.

Derivation and validation of the automated search algorithms to identify cognitive impairment and dementia in electronic health records.

PubMed

Amra, Sakusic; O'Horo, John C; Singh, Tarun D; Wilson, Gregory A; Kashyap, Rahul; Petersen, Ronald; Roberts, Rosebud O; Fryer, John D; Rabinstein, Alejandro A; Gajic, Ognjen

2017-02-01

Long-term cognitive impairment is a common and important problem in survivors of critical illness. We developed electronic search algorithms to identify cognitive impairment and dementia from the electronic medical records (EMRs) that provide opportunity for big data analysis. Eligible patients met 2 criteria. First, they had a formal cognitive evaluation by The Mayo Clinic Study of Aging. Second, they were hospitalized in intensive care unit at our institution between 2006 and 2014. The "criterion standard" for diagnosis was formal cognitive evaluation supplemented by input from an expert neurologist. Using all available EMR data, we developed and improved our algorithms in the derivation cohort and validated them in the independent validation cohort. Of 993 participants who underwent formal cognitive testing and were hospitalized in intensive care unit, we selected 151 participants at random to form the derivation and validation cohorts. The automated electronic search algorithm for cognitive impairment was 94.3% sensitive and 93.0% specific. The search algorithms for dementia achieved respective sensitivity and specificity of 97% and 99%. EMR search algorithms significantly outperformed International Classification of Diseases codes. Automated EMR data extractions for cognitive impairment and dementia are reliable and accurate and can serve as acceptable and efficient alternatives to time-consuming manual data review. Copyright © 2016 Elsevier Inc. All rights reserved.

Radiation safety among cardiology fellows.

PubMed

Kim, Candice; Vasaiwala, Samip; Haque, Faizul; Pratap, Kiran; Vidovich, Mladen I

2010-07-01

Cardiology fellows can be exposed to high radiation levels during procedures. Proper radiation training and implementation of safety procedures is of critical importance in lowering physician health risks associated with radiation exposure. Participants were cardiology fellows in the United States (n = 2,545) who were contacted by e-mail to complete an anonymous survey regarding the knowledge and practice of radiation protection during catheterization laboratory procedures. An on-line survey engine, SurveyMonkey, was used to distribute and collect the results of the 10-question survey. The response rate was 10.5%. Of the 267 respondents, 82% had undergone formal radiation safety training. Only 58% of the fellows were aware of their hospital's pregnancy radiation policy and 60% knew how to contact the hospital's radiation safety officer. Although 52% of the fellows always wore a dosimeter, 81% did not know their level of radiation exposure in the previous year and only 74% of fellows knew the safe levels of radiation exposure. The fellows who had received formal training were more likely to be aware of their pregnancy policy, to know the contact information of their radiation safety officer, to be aware of the safe levels of radiation exposure, to use dosimeters and RadPad consistently, and to know their own level of radiation exposure in the previous year. In conclusion, cardiology fellows have not been adequately educated about radiation safety. A concerted effort directed at physician safety in the workplace from the regulatory committees overseeing cardiology fellowships should be encouraged. Published by Elsevier Inc.

Cost-Effective Strategies for Rural Community Outreach, Hawaii, 2010–2011

PubMed Central

Barbato, Anna; Holuby, R. Scott; Ciarleglio, Anita E.; Taniguchi, Ronald

2014-01-01

Three strategies designed to maximize attendance at educational sessions on chronic disease medication safety in older adults in rural areas were implemented sequentially and compared for cost-effectiveness: 1) existing community groups and events, 2) formal advertisement, and 3) employer-based outreach. Cost-effectiveness was measured by comparing overall cost per attendee recruited and number of attendees per event. The overall cost per attendee was substantially higher for the formal advertising strategy, which produced the lowest number of attendees per event. Leveraging existing community events and employers in rural areas was more cost-effective than formal advertisement for recruiting rural community members. PMID:25496555

Cost-effective strategies for rural community outreach, Hawaii, 2010-2011.

PubMed

Pellegrin, Karen L; Barbato, Anna; Holuby, R Scott; Ciarleglio, Anita E; Taniguchi, Ronald

2014-12-11

Three strategies designed to maximize attendance at educational sessions on chronic disease medication safety in older adults in rural areas were implemented sequentially and compared for cost-effectiveness: 1) existing community groups and events, 2) formal advertisement, and 3) employer-based outreach. Cost-effectiveness was measured by comparing overall cost per attendee recruited and number of attendees per event. The overall cost per attendee was substantially higher for the formal advertising strategy, which produced the lowest number of attendees per event. Leveraging existing community events and employers in rural areas was more cost-effective than formal advertisement for recruiting rural community members.

Toward a Formal Evaluation of Refactorings

NASA Technical Reports Server (NTRS)

Paul, John; Kuzmina, Nadya; Gamboa, Ruben; Caldwell, James

2008-01-01

Refactoring is a software development strategy that characteristically alters the syntactic structure of a program without changing its external behavior [2]. In this talk we present a methodology for extracting formal models from programs in order to evaluate how incremental refactorings affect the verifiability of their structural specifications. We envision that this same technique may be applicable to other types of properties such as those that concern the design and maintenance of safety-critical systems.

Safety validation test equipment operation

NASA Astrophysics Data System (ADS)

Kurosaki, Tadaaki; Watanabe, Takashi

1992-08-01

An overview of the activities conducted on safety validation test equipment operation for materials used for NASA manned missions is presented. Safety validation tests, such as flammability, odor, offgassing, and so forth were conducted in accordance with NASA-NHB-8060.1C using test subjects common with those used by NASA, and the equipment used were qualified for their functions and performances in accordance with NASDA-CR-99124 'Safety Validation Test Qualification Procedures.' Test procedure systems were established by preparing 'Common Procedures for Safety Validation Test' as well as test procedures for flammability, offgassing, and odor tests. The test operation organization chaired by the General Manager of the Parts and Material Laboratory of NASDA (National Space Development Agency of Japan) was established, and the test leaders and operators in the organization were qualified in accordance with the specified procedures. One-hundred-one tests had been conducted so far by the Parts and Material Laboratory according to the request submitted by the manufacturers through the Space Station Group and the Safety and Product Assurance for Manned Systems Office.

Formal Specification and Validation of a Hybrid Connectivity Restoration Algorithm for Wireless Sensor and Actor Networks †

PubMed Central

Imran, Muhammad; Zafar, Nazir Ahmad

2012-01-01

Maintaining inter-actor connectivity is extremely crucial in mission-critical applications of Wireless Sensor and Actor Networks (WSANs), as actors have to quickly plan optimal coordinated responses to detected events. Failure of a critical actor partitions the inter-actor network into disjoint segments besides leaving a coverage hole, and thus hinders the network operation. This paper presents a Partitioning detection and Connectivity Restoration (PCR) algorithm to tolerate critical actor failure. As part of pre-failure planning, PCR determines critical/non-critical actors based on localized information and designates each critical node with an appropriate backup (preferably non-critical). The pre-designated backup detects the failure of its primary actor and initiates a post-failure recovery process that may involve coordinated multi-actor relocation. To prove the correctness, we construct a formal specification of PCR using Z notation. We model WSAN topology as a dynamic graph and transform PCR to corresponding formal specification using Z notation. Formal specification is analyzed and validated using the Z Eves tool. Moreover, we simulate the specification to quantitatively analyze the efficiency of PCR. Simulation results confirm the effectiveness of PCR and the results shown that it outperforms contemporary schemes found in the literature.

Validation of the Federal Aviation Administration Air Traffic Control Specialist Pre-Training Screen.

DOT National Transportation Integrated Search

1994-02-01

Two formal validation studies of the Air Traffic Control Specialist Pre Training Screen (ATCS/PTS), a 5 day computer administered test battery, are described. The ATCS/PTS was designed to replace the 9 week US Federal Aviation Administration (FAA) Ac...

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.

Software development for safety-critical medical applications

NASA Technical Reports Server (NTRS)

Knight, John C.

1992-01-01

There are many computer-based medical applications in which safety and not reliability is the overriding concern. Reduced, altered, or no functionality of such systems is acceptable as long as no harm is done. A precise, formal definition of what software safety means is essential, however, before any attempt can be made to achieve it. Without this definition, it is not possible to determine whether a specific software entity is safe. A set of definitions pertaining to software safety will be presented and a case study involving an experimental medical device will be described. Some new techniques aimed at improving software safety will also be discussed.

Cross-validation of an employee safety climate model in Malaysia.

PubMed

Bahari, Siti Fatimah; Clarke, Sharon

2013-06-01

Whilst substantial research has investigated the nature of safety climate, and its importance as a leading indicator of organisational safety, much of this research has been conducted with Western industrial samples. The current study focuses on the cross-validation of a safety climate model in the non-Western industrial context of Malaysian manufacturing. The first-order factorial validity of Cheyne et al.'s (1998) [Cheyne, A., Cox, S., Oliver, A., Tomas, J.M., 1998. Modelling safety climate in the prediction of levels of safety activity. Work and Stress, 12(3), 255-271] model was tested, using confirmatory factor analysis, in a Malaysian sample. Results showed that the model fit indices were below accepted levels, indicating that the original Cheyne et al. (1998) safety climate model was not supported. An alternative three-factor model was developed using exploratory factor analysis. Although these findings are not consistent with previously reported cross-validation studies, we argue that previous studies have focused on validation across Western samples, and that the current study demonstrates the need to take account of cultural factors in the development of safety climate models intended for use in non-Western contexts. The results have important implications for the transferability of existing safety climate models across cultures (for example, in global organisations) and highlight the need for future research to examine cross-cultural issues in relation to safety climate. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

Ethics in occupational health and safety: case studies from Gujarat.

PubMed

Patel, Jagdish; David, Siddarth

2016-01-01

Rapid industrialisation in India is giving employment to millions of people in the formal sector, and many more in the unorganised sector. However, the absence of clear policies, poorly enforced regulations, lack of systematic reporting of occupational diseases, lamentable socioeconomic conditions of the workers and their limited access to healthcare make occupational health and safety (OHS) a critical area.

The Safety Culture Enactment Questionnaire (SCEQ): Theoretical model and empirical validation.

PubMed

de Castro, Borja López; Gracia, Francisco J; Tomás, Inés; Peiró, José M

2017-06-01

This paper presents the Safety Culture Enactment Questionnaire (SCEQ), designed to assess the degree to which safety is an enacted value in the day-to-day running of nuclear power plants (NPPs). The SCEQ is based on a theoretical safety culture model that is manifested in three fundamental components of the functioning and operation of any organization: strategic decisions, human resources practices, and daily activities and behaviors. The extent to which the importance of safety is enacted in each of these three components provides information about the pervasiveness of the safety culture in the NPP. To validate the SCEQ and the model on which it is based, two separate studies were carried out with data collection in 2008 and 2014, respectively. In Study 1, the SCEQ was administered to the employees of two Spanish NPPs (N=533) belonging to the same company. Participants in Study 2 included 598 employees from the same NPPs, who completed the SCEQ and other questionnaires measuring different safety outcomes (safety climate, safety satisfaction, job satisfaction and risky behaviors). Study 1 comprised item formulation and examination of the factorial structure and reliability of the SCEQ. Study 2 tested internal consistency and provided evidence of factorial validity, validity based on relationships with other variables, and discriminant validity between the SCEQ and safety climate. Exploratory Factor Analysis (EFA) carried out in Study 1 revealed a three-factor solution corresponding to the three components of the theoretical model. Reliability analyses showed strong internal consistency for the three scales of the SCEQ, and each of the 21 items on the questionnaire contributed to the homogeneity of its theoretically developed scale. Confirmatory Factor Analysis (CFA) carried out in Study 2 supported the internal structure of the SCEQ; internal consistency of the scales was also supported. Furthermore, the three scales of the SCEQ showed the expected correlation patterns with the measured safety outcomes. Finally, results provided evidence of discriminant validity between the SCEQ and safety climate. We conclude that the SCEQ is a valid, reliable instrument supported by a theoretical framework, and it is useful to measure the enactment of safety culture in NPPs. Copyright © 2017 Elsevier Ltd. All rights reserved.

Health and safety programs for art and theater schools.

PubMed

McCann, M

2001-01-01

A wide variety of health and safety hazards exist in schools and colleges of art and theater due to a lack of formal health and safety programs and a failure to include health and safety concerns during planning of new facilities and renovation of existing facilities. This chapter discusses the elements of a health and safety program as well as safety-related structural and equipment needs that should be in the plans for any school of art or theater. These elements include curriculum content, ventilation, storage, housekeeping, waste management, fire and explosion prevention, machine and tool safety, electrical safety, noise, heat stress, and life safety and emergency procedures and equipment. Ideally, these elements should be incorporated into the plans for any new facilities, but ongoing programs can also benefit from a review of existing health and safety programs.

Abstract Model of the SATS Concept of Operations: Initial Results and Recommendations

NASA Technical Reports Server (NTRS)

Dowek, Gilles; Munoz, Cesar; Carreno, Victor A.

2004-01-01

An abstract mathematical model of the concept of operations for the Small Aircraft Transportation System (SATS) is presented. The Concept of Operations consist of several procedures that describe nominal operations for SATS, Several safety properties of the system are proven using formal techniques. The final goal of the verification effort is to show that under nominal operations, aircraft are safely separated. The abstract model was written and formally verified in the Prototype Verification System (PVS).

Can Formal Methods Provide (Necessary and) Sufficient Conditions for Measurement?

ERIC Educational Resources Information Center

Mari, Luca

2017-01-01

In his focus article, "Rethinking Traditional Methods of Survey Validation," published in this issue of "Measurement: Interdisciplinary Research and Perspectives," Andrew Maul introduces and discusses several foundational issues and concludes that self-report measures may be particularly difficult to validate and may fall short…

48 CFR 1852.234-1 - Notice of Earned Value Management System.

Code of Federal Regulations, 2014 CFR

2014-10-01

... according to paragraph (a); (vi) Provide documentation describing the process and results, including..., provide a schedule of events leading up to formal validation and Government acceptance of the Contractor's...) outlines the requirements for conducting a progress assistance visit and validation compliance review. (2...

48 CFR 1852.234-1 - Notice of Earned Value Management System.

Code of Federal Regulations, 2013 CFR

2013-10-01

... according to paragraph (a); (vi) Provide documentation describing the process and results, including..., provide a schedule of events leading up to formal validation and Government acceptance of the Contractor's...) outlines the requirements for conducting a progress assistance visit and validation compliance review. (2...

48 CFR 1852.234-1 - Notice of Earned Value Management System.

Code of Federal Regulations, 2012 CFR

2012-10-01

... according to paragraph (a); (vi) Provide documentation describing the process and results, including..., provide a schedule of events leading up to formal validation and Government acceptance of the Contractor's...) outlines the requirements for conducting a progress assistance visit and validation compliance review. (2...

48 CFR 1852.234-1 - Notice of Earned Value Management System.

Code of Federal Regulations, 2011 CFR

2011-10-01

... according to paragraph (a); (vi) Provide documentation describing the process and results, including..., provide a schedule of events leading up to formal validation and Government acceptance of the Contractor's...) outlines the requirements for conducting a progress assistance visit and validation compliance review. (2...

Mission safety evaluation report for STS-35: Postflight edition

NASA Technical Reports Server (NTRS)

Hill, William C.; Finkel, Seymour I.

1991-01-01

Space Transportation System 35 (STS-35) safety risk factors that represent a change from previous flights that had an impact on this flight, and factors that were unique to this flight are discussed. While some changes to the safety risk baseline since the previous flight are included to highlight their significance in risk level change, the primary purpose is to insure that changes which were too late too include in formal changes through the Failure Modes and Effects Analysis/Critical Items List (FMEA/CIL) and Hazard Analysis process are documented along with the safety position, which includes the acceptance rationale.

Study on lockage safety of LNG-fueled ships based on FSA.

PubMed

Lv, Pengfei; Zhuang, Yuan; Deng, Jian; Su, Wei

2017-01-01

In the present study, formal safety assessment (FSA) is introduced to investigate lockage safety of LNG-fueled ships. Risk sources during lockage of LNG-fueled ships in four typical scenarios, namely, navigation between two dams, lockage, anchorage, and fueling, are identified, and studied in combination with fundamental leakage probabilities of various components of LNG storage tanks, and simulation results of accident consequences. Some suggestions for lockage safety management of LNG-fueled ships are then proposed. The present research results have certain practical significance for promoting applications of LNG-fueled ships along Chuanjiang River and in Three Gorges Reservoir Region.

Development of the Consumer Refrigerator Safety Questionnaire: A Measure of Consumer Perceptions and Practices.

PubMed

Cairnduff, Victoria; Dean, Moira; Koidis, Anastasios

2016-09-01

Food preparation and storage behaviors in the home deviating from the "best practice" food safety recommendations may result in foodborne illnesses. Currently, there are limited tools available to fully evaluate the consumer knowledge, perceptions, and behavior in the area of refrigerator safety. The current study aimed to develop a valid and reliable tool in the form of a questionnaire, the Consumer Refrigerator Safety Questionnaire (CRSQ), for assessing systematically all these aspects. Items relating to refrigerator safety knowledge (n =17), perceptions (n =46), and reported behavior (n =30) were developed and pilot tested by an expert reference group and various consumer groups to assess face and content validity (n =20), item difficulty and consistency (n =55), and construct validity (n =23). The findings showed that the CRSQ has acceptable face and content validity with acceptable levels of item difficulty. Item consistency was observed for 12 of 15 in refrigerator safety knowledge. Further, all 5 of the subscales of consumer perceptions of refrigerator safety practices relating to risk of developing foodborne disease showed acceptable internal consistency (Cronbach's α value > 0.8). Construct validity of the CRSQ was shown to be very good (P = 0.022). The CRSQ exhibited acceptable test-retest reliability at 14 days with the majority of knowledge items (93.3%) and reported behavior items (96.4%) having correlation coefficients of greater than 0.70. Overall, the CRSQ was deemed valid and reliable in assessing refrigerator safety knowledge and behavior; therefore, it has the potential for future use in identifying groups of individuals at increased risk of deviating from recommended refrigerator safety practices, as well as the assessment of refrigerator safety knowledge and behavior for use before and after an intervention.

Analytical methodology for safety validation of computer controlled subsystems. Volume 1 : state-of-the-art and assessment of safety verification/validation methodologies

DOT National Transportation Integrated Search

1995-09-01

This report describes the development of a methodology designed to assure that a sufficiently high level of safety is achieved and maintained in computer-based systems which perform safety critical functions in high-speed rail or magnetic levitation ...

Dimensions of Safety Climate among Iranian Nurses.

PubMed

Konjin, Z Naghavi; Shokoohi, Y; Zarei, F; Rahimzadeh, M; Sarsangi, V

2015-10-01

Workplace safety has been a concern of workers and managers for decades. Measuring safety climate is crucial in improving safety performance. It is also a method of benchmarking safety perception. To develop and validate a psychometrics scale for measuring nurses' safety climate. Literature review, subject matter experts and nurse's judgment were used in items developing. Content validity and reliability for new tool were tested by content validity index (CVI) and test-retest analysis, respectively. Exploratory factor analysis (EFA) with varimax rotation was used to improve the interpretation of latent factors. A 40-item scale in 6 factors was developed, which could explain 55% of the observed variance. The 6 factors included employees' involvement in safety and management support, compliance with safety rules, safety training and accessibility to personal protective equipment, hindrance to safe work, safety communication and job pressure, and individual risk perception. The proposed scale can be used in identifying the needed areas to implement interventions in safety climate of nurses.

The development and validation of a psychological contract of safety scale.

PubMed

Walker, Arlene

2010-08-01

This paper builds on previous research by the author and describes the development and validation of a new measure of the psychological contract of safety. The psychological contract of safety is defined as the beliefs of individuals about reciprocal safety obligations inferred from implicit and explicit promises. A psychological contract is established when an individual believes that perceived employer and employee safety obligations are contingent on each other. A pilot test of the measure is first undertaken with participants from three different occupations: nurses, construction workers, and meat processing workers (N=99). Item analysis is used to refine the measure and provide initial validation of the scale. A larger validation study is then conducted with a participant sample of health care workers (N=424) to further refine the measure and to determine the psychometric properties of the scale. Item and correlational analyses produced the final employer and employee obligations scales, consisting of 21 and 17 items, respectively. Factor analyses identified two underlying dimensions in each scale comparable to that previously established in the organizational literature. These transactional and relational-type obligations provided construct validity of the scale. Internal consistency ratings using Cronbach's alpha found the components of the psychological contract of safety measure to be reliable. The refined and validated psychological contract of safety measure will allow investigation of the positive and negative outcomes associated with fulfilment and breach of the psychological contract of safety in future research. 2010 Elsevier Ltd. All rights reserved.

Workforce perceptions of hospital safety culture: development and validation of the patient safety climate in healthcare organizations survey.

PubMed

Singer, Sara; Meterko, Mark; Baker, Laurence; Gaba, David; Falwell, Alyson; Rosen, Amy

2007-10-01

To describe the development of an instrument for assessing workforce perceptions of hospital safety culture and to assess its reliability and validity. Primary data collected between March 2004 and May 2005. Personnel from 105 U.S. hospitals completed a 38-item paper and pencil survey. We received 21,496 completed questionnaires, representing a 51 percent response rate. Based on review of existing safety climate surveys, we developed a list of key topics pertinent to maintaining a culture of safety in high-reliability organizations. We developed a draft questionnaire to address these topics and pilot tested it in four preliminary studies of hospital personnel. We modified the questionnaire based on experience and respondent feedback, and distributed the revised version to 42,249 hospital workers. We randomly divided respondents into derivation and validation samples. We applied exploratory factor analysis to responses in the derivation sample. We used those results to create scales in the validation sample, which we subjected to multitrait analysis (MTA). We identified nine constructs, three organizational factors, two unit factors, three individual factors, and one additional factor. Constructs demonstrated substantial convergent and discriminant validity in the MTA. Cronbach's alpha coefficients ranged from 0.50 to 0.89. It is possible to measure key salient features of hospital safety climate using a valid and reliable 38-item survey and appropriate hospital sample sizes. This instrument may be used in further studies to better understand the impact of safety climate on patient safety outcomes.

Assessing the perceived level of institutional support for the second victim after a patient safety event.

PubMed

Joesten, Leroy; Cipparrone, Nancy; Okuno-Jones, Susan; DuBose, Edwin R

2015-06-01

The objective of this study was to establish a baseline of perceived availability of institutional support services or interventions and experiences following an adverse patient safety event (PSE) in a 650-bed children and adult community teaching hospital. Investigators queried associates about their experiences after a PSE, what institutional support services or interventions they perceived to be available, and how helpful used services were. The investigators used an online modified version of a PSE survey developed by several health related organizations in Boston. One hundred twenty evaluable surveys were analyzed. Sixty-eight percent of respondents were nurses, 99% of whom were female. Only 10% to 30% of respondents reported that various support services or interventions were actively offered, and 30% to 60% indicated that they were not available. Respondents reported having experienced several distressing symptoms after a PSE, most notably, troubling memories (56%) and worry about lawsuits (37%). Less than 32% "agreed" or "strongly agreed" that they could report concerns without fear of retribution or punitive action. More respondents experienced support from clinical colleagues (64%) than from their manager or department chair (38%). These results validate a need by associates for emotional support after a PSE and that associates' perception of available formal institutional support services or interventions is low.

Psychometrics of the Home Safety Self-Assessment Tool (HSSAT) to prevent falls in community-dwelling older adults.

PubMed

Tomita, Machiko R; Saharan, Sumandeep; Rajendran, Sheela; Nochajski, Susan M; Schweitzer, Jo A

2014-01-01

OBJECTIVE. To identify psychometric properties of the Home Safety Self-Assessment Tool (HSSAT) to prevent falls in community-dwelling older adults. METHOD. We tested content validity, test-retest reliability, interrater reliability, construct validity, convergent and discriminant validity, and responsiveness to change. RESULTS. The content validity index was .98, the intraclass correlation coefficient for test-retest reliability was .97, and the interrater reliability was .89. The difference on identified risk factors between the use and nonuse of the HSSAT was significant (p = .005). Convergent validity with the Centers for Disease Control and Prevention Home Safety Checklist was high (r = .65), and discriminant validity with fear of falling was very low (r = .10). The responsiveness to change was moderate (standardized response mean = 0.57). CONCLUSION. The HSSAT is a reliable and valid instrument to identify fall risks in a home environment, and the HSSAT booklet is effective as educational material leading to improvement in home safety. Copyright © 2014 by the American Occupational Therapy Association, Inc.

Perspectives on Validation of High-Throughput Assays Supporting 21st Century Toxicity Testing

EPA Science Inventory

In vitro high-throughput screening (HTS) assays are seeing increasing use in toxicity testing. HTS assays can simultaneously test many chemicals but have seen limited use in the regulatory arena, in part because of the need to undergo rigorous, time-consuming formal validation. ...

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.

Primate cognition and the bared-teeth display: a reevaluation of the concept of formal dominance.

PubMed

Maestripieri, D

1996-12-01

The cognitive implications of the phenomenon of dominance in nonhuman primates and other animals have been poorly addressed. This article shows that the concept of formal dominance currently used in the primatological literature is inherently dependent on the assumption that primates are capable of attribution of knowledge to other individuals. Although this assumption has never been made explicitly, without it the concept of formal dominance is virtually indistinguishable from other, more traditional views of dominance. Recent studies have failed to demonstrate attribution of knowledge in nonhuman primates, thus questioning the validity of formal dominance. The concept of formal dominance was originally proposed to account for a discrepancy between dominance hierarchies based on aggressive behavior and dominance hierarchies based on submissive signals. This article shows that such a discrepancy can be accounted for without invoking complex cognitive processes such as attribution of knowledge.

The Portuguese formal social support for autonomy and dependence in pain inventory (FSSADI_PAIN): a preliminary validation study.

PubMed

Matos, Marta; Bernardes, Sónia F

2013-09-01

Development and preliminary validation of a Portuguese measure of perceived Formal Social Support for Autonomy and Dependence in Pain (FSSADI_PAIN). One hundred and fifty-one older adults (88.1% women), between 56 and 94 years of age (M = 75.41; SD = 9.11), who attended one of the following institutions--day care centre (33.1%), nursing home (36.4%) and senior university (30.5%)--were recruited for this study. Along with the FSSADI_PAIN, participants filled out the Portuguese versions of the Brief Pain Inventory (Azevedo et al., 2007, Dor, 15, 6) and the Social Support Scale of Medical Outcomes Survey (Pais-Ribeiro & Ponte, 2009, Psicologia, Saúde & Doença, 10, 163). The factorial structure reflected the functions of perceived promotion of (1) dependence and (2) autonomy, showing good internal consistency (α > .70) and sensitivity indices. The FSSADI_PAIN showed good content, discriminant and criterion validity; it differentiated the perceptions of promotion of dependence/autonomy according to individual's pain severity and disability, as well as the type of institution. These preliminary findings suggest that the FSSADI_PAIN is an innovative and promising measure of perceived formal social support adapted to pain-related contexts. © 2012 The British Psychological Society.

Determining brain fitness to fight: Has the time come?

PubMed

Seifert, Tad; Bernick, Charles; Jordan, Barry; Alessi, Anthony; Davidson, Jeff; Cantu, Robert; Giza, Christopher; Goodman, Margaret; Benjamin, Johnny

2015-11-01

Professional boxing is associated with a risk of chronic neurological injury, with up to 20-50% of former boxers exhibiting symptoms of chronic brain injury. Chronic traumatic brain injury encompasses a spectrum of disorders that are associated with long-term consequences of brain injury and remains the most difficult safety challenge in modern-day boxing. Despite these concerns, traditional guidelines used for return to sport participation after concussion are inconsistently applied in boxing. Furthermore, few athletic commissions require either formal consultation with a neurological specialist (i.e. neurologist, neurosurgeon, or neuropsychologist) or formal neuropsychological testing prior to return to fight. In order to protect the health of boxers and maintain the long-term viability of a sport associated with exposure to repetitive head trauma, we propose a set of specific requirements for brain safety that all state athletic commissions would implement.

New safety rules challenge U. K. operators, regulators

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

Hudson, J.

1994-08-15

Offshore safety regulations based on lessons learned from the Piper Alpha blast of 1988 have been in operation in the U.K. for a year. The Offshore Installations (Safety Case) Regulations 1992 make operators of fixed and mobile installations (the duty holders'') responsible for producing a formal safety assessment, or safety case, for each installation. After the end of November 1995 it will be an offense to operate an installation without a safety case which has been approved by the government's Health and Safety Executive (HSE). Producing safety cases for installations is a major task for duty holder, while assessing themmore » is a huge under taking for HSE's Offshore Safety Division (OSD). This paper reviews how HSE has established management arrangements to handle safety cases, considers progress in assessment, highlights some of the important lessons learned, and look to the future.« less

Specification and simulation of behavior of the Continuous Infusion Insulin Pump system.

PubMed

Babamir, Seyed Morteza; Dehkordi, Mehdi Borhani

2014-01-01

Continuous Infusion Insulin Pump (CIIP) system is responsible for monitoring diabetic blood sugar. In this paper, we aim to specify and simulate the CIIP software behavior. To this end, we first: (1) presented a model consisting of the CIIP system behavior in response to its environment (diabetic) behavior and (2) we formally defined the safety requirements of the system environment (diabetic) in the Z formal modeling language. Such requirements should be satisfied by the CIIP software. Finally, we programmed the model and requirements.

78 FR 32184 - HACCP Systems Validation

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-29

... DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR part 417 [Docket No. FSIS-2009-0019] HACCP Systems Validation AGENCY: Food Safety and Inspection Service, USDA. ACTION: Notice of public meeting and request for comments. SUMMARY: The Food Safety and Inspection Service (FSIS) is...

Workforce Perceptions of Hospital Safety Culture: Development and Validation of the Patient Safety Climate in Healthcare Organizations Survey

PubMed Central

Singer, Sara; Meterko, Mark; Baker, Laurence; Gaba, David; Falwell, Alyson; Rosen, Amy

2007-01-01

Objective To describe the development of an instrument for assessing workforce perceptions of hospital safety culture and to assess its reliability and validity. Data Sources/Study Setting Primary data collected between March 2004 and May 2005. Personnel from 105 U.S. hospitals completed a 38-item paper and pencil survey. We received 21,496 completed questionnaires, representing a 51 percent response rate. Study Design Based on review of existing safety climate surveys, we developed a list of key topics pertinent to maintaining a culture of safety in high-reliability organizations. We developed a draft questionnaire to address these topics and pilot tested it in four preliminary studies of hospital personnel. We modified the questionnaire based on experience and respondent feedback, and distributed the revised version to 42,249 hospital workers. Data Collection We randomly divided respondents into derivation and validation samples. We applied exploratory factor analysis to responses in the derivation sample. We used those results to create scales in the validation sample, which we subjected to multitrait analysis (MTA). Principal Findings We identified nine constructs, three organizational factors, two unit factors, three individual factors, and one additional factor. Constructs demonstrated substantial convergent and discriminant validity in the MTA. Cronbach's α coefficients ranged from 0.50 to 0.89. Conclusions It is possible to measure key salient features of hospital safety climate using a valid and reliable 38-item survey and appropriate hospital sample sizes. This instrument may be used in further studies to better understand the impact of safety climate on patient safety outcomes. PMID:17850530

Formal Methods Applications in Air Transportation

NASA Technical Reports Server (NTRS)

Farley, Todd

2009-01-01

The U.S. air transportation system is the most productive in the world, moving far more people and goods than any other. It is also the safest system in the world, thanks in part to its venerable air traffic control system. But as demand for air travel continues to grow, the air traffic control system s aging infrastructure and labor-intensive procedures are impinging on its ability to keep pace with demand. And that impinges on the growth of our economy. Air traffic control modernization has long held the promise of a more efficient air transportation system. Part of NASA s current mission is to develop advanced automation and operational concepts that will expand the capacity of our national airspace system while still maintaining its excellent record for safety. It is a challenging mission, as efforts to modernize have, for decades, been hamstrung by the inability to assure safety to the satisfaction of system operators, system regulators, and/or the traveling public. In this talk, we ll provide a brief history of air traffic control, focusing on the tension between efficiency and safety assurance, and the promise of formal methods going forward.

ADGS-2100 Adaptive Display and Guidance System Window Manager Analysis

NASA Technical Reports Server (NTRS)

Whalen, Mike W.; Innis, John D.; Miller, Steven P.; Wagner, Lucas G.

2006-01-01

Recent advances in modeling languages have made it feasible to formally specify and analyze the behavior of large system components. Synchronous data flow languages, such as Lustre, SCR, and RSML-e are particularly well suited to this task, and commercial versions of these tools such as SCADE and Simulink are growing in popularity among designers of safety critical systems, largely due to their ability to automatically generate code from the models. At the same time, advances in formal analysis tools have made it practical to formally verify important properties of these models to ensure that design defects are identified and corrected early in the lifecycle. This report describes how these tools have been applied to the ADGS-2100 Adaptive Display and Guidance Window Manager being developed by Rockwell Collins Inc. This work demonstrates how formal methods can be easily and cost-efficiently used to remove defects early in the design cycle.

Helping System Engineers Bridge the Peaks

NASA Technical Reports Server (NTRS)

Rungta, Neha; Tkachuk, Oksana; Person, Suzette; Biatek, Jason; Whalen, Michael W.; Castle, Joseph; Castle, JosephGundy-Burlet, Karen

2014-01-01

In our experience at NASA, system engineers generally follow the Twin Peaks approach when developing safety-critical systems. However, iterations between the peaks require considerable manual, and in some cases duplicate, effort. A significant part of the manual effort stems from the fact that requirements are written in English natural language rather than a formal notation. In this work, we propose an approach that enables system engineers to leverage formal requirements and automated test generation to streamline iterations, effectively "bridging the peaks". The key to the approach is a formal language notation that a) system engineers are comfortable with, b) is supported by a family of automated V&V tools, and c) is semantically rich enough to describe the requirements of interest. We believe the combination of formalizing requirements and providing tool support to automate the iterations will lead to a more efficient Twin Peaks implementation at NASA.

Probability of Loss of Assured Safety in Systems with Multiple Time-Dependent Failure Modes: Incorporation of Delayed Link Failure in the Presence of Aleatory Uncertainty.

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

Helton, Jon C.; Brooks, Dusty Marie; Sallaberry, Cedric Jean-Marie.

Probability of loss of assured safety (PLOAS) is modeled for weak link (WL)/strong link (SL) systems in which one or more WLs or SLs could potentially degrade into a precursor condition to link failure that will be followed by an actual failure after some amount of elapsed time. The following topics are considered: (i) Definition of precursor occurrence time cumulative distribution functions (CDFs) for individual WLs and SLs, (ii) Formal representation of PLOAS with constant delay times, (iii) Approximation and illustration of PLOAS with constant delay times, (iv) Formal representation of PLOAS with aleatory uncertainty in delay times, (v) Approximationmore » and illustration of PLOAS with aleatory uncertainty in delay times, (vi) Formal representation of PLOAS with delay times defined by functions of link properties at occurrence times for failure precursors, (vii) Approximation and illustration of PLOAS with delay times defined by functions of link properties at occurrence times for failure precursors, and (viii) Procedures for the verification of PLOAS calculations for the three indicated definitions of delayed link failure.« less

Quality of radiotherapy services in post-Soviet countries: An IAEA survey.

PubMed

Rosenblatt, Eduardo; Fidarova, Elena; Ghosh, Sunita; Zubizarreta, Eduardo; Unterkirhere, Olga; Semikoz, Natalia; Sinaika, Valery; Kim, Viktor; Karamyan, Nerses; Isayev, Isa; Akbarov, Kamal; Lomidze, Darejan; Bondareva, Oksana; Tuzlucov, Piotr; Zardodkhonova, Manzura; Tkachev, Sergey; Kislyakova, Marina; Alimov, Jamshid; Pidlubna, Tetiana; Barton, Michael; Mackillop, William

2018-04-25

The quality of radiotherapy services in post-Soviet countries has not yet been studied following a formal methodology. The IAEA conducted a survey using two sets of validated radiation oncology quality indicators (ROIs). Eleven post-Soviet countries were assessed. A coordinator was designated for each country and acted as the liaison between the country and the IAEA. The methodology was a one-time cross-sectional survey using a 58-question tool in Russian. The questionnaire was based on two validated sets of ROIs: for radiotherapy centres, the indicators proposed by Cionini et al., and for data at the country level, the Australasian ROIs. The overall response ratio was 66.3%, but for the Russian Federation, it was 24%. Data were updated on radiotherapy infrastructure and equipment. 256 radiotherapy centres are operating 275 linear accelerators and 337 Cobalt-60 units. 61% of teletherapy machines are older than ten years. Analysis of ROIs revealed significant differences between these countries and radiotherapy practices in the West. Naming, task profile and education programmes of radiotherapy professionals are different than in the West. Most countries need modernization of their radiotherapy infrastructure coupled with adequate staffing numbers and updated education programmes focusing on evidence-based medicine, quality, and safety. Copyright © 2018 Elsevier B.V. All rights reserved.

Products of composite operators in the exact renormalization group formalism

NASA Astrophysics Data System (ADS)

Pagani, C.; Sonoda, H.

2018-02-01

We discuss a general method of constructing the products of composite operators using the exact renormalization group formalism. Considering mainly the Wilson action at a generic fixed point of the renormalization group, we give an argument for the validity of short-distance expansions of operator products. We show how to compute the expansion coefficients by solving differential equations, and test our method with some simple examples.

Decidability of formal theories and hyperincursivity theory

NASA Astrophysics Data System (ADS)

Grappone, Arturo G.

2000-05-01

This paper shows the limits of the Proof Standard Theory (briefly, PST) and gives some ideas of how to build a proof anticipatory theory (briefly, PAT) that has no such limits. Also, this paper considers that Gödel's proof of the undecidability of Principia Mathematica formal theory is not valid for axiomatic theories that use a PAT to build their proofs because the (hyper)incursive functions are self-representable.

Formal Validation of Aerospace Software

NASA Astrophysics Data System (ADS)

Lesens, David; Moy, Yannick; Kanig, Johannes

2013-08-01

Any single error in critical software can have catastrophic consequences. Even though failures are usually not advertised, some software bugs have become famous, such as the error in the MIM-104 Patriot. For space systems, experience shows that software errors are a serious concern: more than half of all satellite failures from 2000 to 2003 involved software. To address this concern, this paper addresses the use of formal verification of software developed in Ada.

Model-Driven Test Generation of Distributed Systems

NASA Technical Reports Server (NTRS)

Easwaran, Arvind; Hall, Brendan; Schweiker, Kevin

2012-01-01

This report describes a novel test generation technique for distributed systems. Utilizing formal models and formal verification tools, spe cifically the Symbolic Analysis Laboratory (SAL) tool-suite from SRI, we present techniques to generate concurrent test vectors for distrib uted systems. These are initially explored within an informal test validation context and later extended to achieve full MC/DC coverage of the TTEthernet protocol operating within a system-centric context.

Fourth NASA Langley Formal Methods Workshop

NASA Technical Reports Server (NTRS)

Holloway, C. Michael (Compiler); Hayhurst, Kelly J. (Compiler)

1997-01-01

This publication consists of papers presented at NASA Langley Research Center's fourth workshop on the application of formal methods to the design and verification of life-critical systems. Topic considered include: Proving properties of accident; modeling and validating SAFER in VDM-SL; requirement analysis of real-time control systems using PVS; a tabular language for system design; automated deductive verification of parallel systems. Also included is a fundamental hardware design in PVS.

Global Perspectives on Recognising Non-Formal and Informal Learning: Why Recognition Matters. Technical and Vocational Education and Training: Issues, Concerns and Prospects. Volume 21

ERIC Educational Resources Information Center

Singh, Madhu

2015-01-01

This book deals with the relevance of recognition, validation and accreditation (RVA) of non-formal and informal learning in education and training, the workplace and society. It examines RVA's strategic policy objectives and best practice features as well as the challenges faced and ways forward as reported by Member States. Special attention is…

On Multi-Objective Based Constitutive Modelling Methodology and Numerical Validation in Small-Hole Drilling of Al6063/SiCp Composites

PubMed Central

Xiang, Junfeng; Xie, Lijing; Gao, Feinong; Zhang, Yu; Yi, Jie; Wang, Tao; Pang, Siqin; Wang, Xibin

2018-01-01

Discrepancies in capturing material behavior of some materials, such as Particulate Reinforced Metal Matrix Composites, by using conventional ad hoc strategy make the applicability of Johnson-Cook constitutive model challenged. Despites applicable efforts, its extended formalism with more fitting parameters would increase the difficulty in identifying constitutive parameters. A weighted multi-objective strategy for identifying any constitutive formalism is developed to predict mechanical behavior in static and dynamic loading conditions equally well. These varying weighting is based on the Gaussian-distributed noise evaluation of experimentally obtained stress-strain data in quasi-static or dynamic mode. This universal method can be used to determine fast and directly whether the constitutive formalism is suitable to describe the material constitutive behavior by measuring goodness-of-fit. A quantitative comparison of different fitting strategies on identifying Al6063/SiCp’s material parameters is made in terms of performance evaluation including noise elimination, correlation, and reliability. Eventually, a three-dimensional (3D) FE model in small-hole drilling of Al6063/SiCp composites, using multi-objective identified constitutive formalism, is developed. Comparison with the experimental observations in thrust force, torque, and chip morphology provides valid evidence on the applicability of the developed multi-objective identification strategy in identifying constitutive parameters. PMID:29324688

Pharmacovigilance systems in developing countries: an evaluative case study in Burkina Faso.

PubMed

Kabore, Lassane; Millet, Pascal; Fofana, Souleymane; Berdai, Driss; Adam, Caroline; Haramburu, Françoise

2013-05-01

Burkina Faso, like other Sub-Saharan African countries, has recently experienced a large-scale deployment of new medicines for the prevention and treatment of notable diseases of public health interest, including malaria, HIV/AIDS and meningitis. This new context rendered the implementation of pharmacovigilance necessary in order to monitor and establish the safety and effectiveness of these medicines. In 2008, the Ministry of Health of Burkina Faso, West Africa, launched a formal pharmacovigilance system to respond to this need. The aim of this study was to evaluate the early-stage pharmacovigilance system of Burkina Faso through a comprehensive and system-based approach with the prospect of identifying areas for improvements. We conducted a descriptive cross-sectional study in Burkina Faso. Sixteen key informants from the National Drug Authority (NDA), public health programmes (PHPs) and hospitals were interviewed. Study participants were selected based on a convenience sampling in the NDA, three teaching hospitals, two regional hospitals and six PHPs. Data were collected using the Indicator-based Pharmacovigilance Assessment Tool (IPAT), a metric instrument recently designed and validated by 'Management Sciences for Health', a US non-profit organization. The evaluation also involved the collection and review of relevant pharmacovigilance-related documentation in the institutions assessed. A scoring system was used for the quantification of assessment results. The NDA of Burkina Faso, the institution statutorily in charge of pharmacovigilance, achieved a performance score of 70 %. The basic structures for pharmacovigilance activities were in place; however, the lack of specific laws dedicated to pharmacovigilance, the lack of national guidelines and standard operating procedures on pharmacovigilance, and the insufficient coordination of pharmacovigilance stakeholders in the country were identified as the main weaknesses. Safety data collected thus far have not led to the identification of local drug-related risks; yet, relevant external safety alerts are monitored and acted upon. In 2010, 31 marketing authorizations were modified to include new safety information; seven others were suspended and the corresponding medicines were withdrawn from the national market. In PHPs, pharmacovigilance activities were not formalized, and in hospitals, pharmacovigilance structures were still under development. Relevant interventions aimed at strengthening the legal framework and structures for pharmacovigilance activities, and improving the coordination of stakeholders countrywide, should be undertaken as soon as possible. Such an investment is necessary before the national pharmacovigilance system is able to collect its own data, generate signals, evaluate and manage local medicine-related risks and then become a genuine tool for public health.

Survey of Verification and Validation Techniques for Small Satellite Software Development

NASA Technical Reports Server (NTRS)

Jacklin, Stephen A.

2015-01-01

The purpose of this paper is to provide an overview of the current trends and practices in small-satellite software verification and validation. This document is not intended to promote a specific software assurance method. Rather, it seeks to present an unbiased survey of software assurance methods used to verify and validate small satellite software and to make mention of the benefits and value of each approach. These methods include simulation and testing, verification and validation with model-based design, formal methods, and fault-tolerant software design with run-time monitoring. Although the literature reveals that simulation and testing has by far the longest legacy, model-based design methods are proving to be useful for software verification and validation. Some work in formal methods, though not widely used for any satellites, may offer new ways to improve small satellite software verification and validation. These methods need to be further advanced to deal with the state explosion problem and to make them more usable by small-satellite software engineers to be regularly applied to software verification. Last, it is explained how run-time monitoring, combined with fault-tolerant software design methods, provides an important means to detect and correct software errors that escape the verification process or those errors that are produced after launch through the effects of ionizing radiation.

'Speaking up' about patient safety concerns and unprofessional behaviour among residents: validation of two scales.

PubMed

Martinez, William; Etchegaray, Jason M; Thomas, Eric J; Hickson, Gerald B; Lehmann, Lisa Soleymani; Schleyer, Anneliese M; Best, Jennifer A; Shelburne, Julia T; May, Natalie B; Bell, Sigall K

2015-11-01

To develop and test the psychometric properties of two new survey scales aiming to measure the extent to which the clinical environment supports speaking up about (a) patient safety concerns and (b) unprofessional behaviour. Residents from six large US academic medical centres completed an anonymous, electronic survey containing questions regarding safety culture and speaking up about safety and professionalism concerns. Confirmatory factor analysis supported two separate, one-factor speaking up climates (SUCs) among residents; one focused on patient safety concerns (SUC-Safe scale) and the other focused on unprofessional behaviour (SUC-Prof scale). Both scales had good internal consistency (Cronbach's α>0.70) and were unique from validated safety and teamwork climate measures (r<0.85 for all correlations), a measure of discriminant validity. The SUC-Safe and SUC-Prof scales were associated with participants' self-reported speaking up behaviour about safety and professionalism concerns (r=0.21, p<0.001 and r=0.22, p<0.001, respectively), a measure of concurrent validity, while teamwork and safety climate scales were not. We created and provided evidence for the reliability and validity of two measures (SUC-Safe and SUC-Prof scales) associated with self-reported speaking up behaviour among residents. These two scales may fill an existing gap in residency and safety culture assessments by measuring the openness of communication about safety and professionalism concerns, two important aspects of safety culture that are under-represented in existing metrics. 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.

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.

Study on lockage safety of LNG-fueled ships based on FSA

PubMed Central

Lv, Pengfei; Zhuang, Yuan; Deng, Jian; Su, Wei

2017-01-01

In the present study, formal safety assessment (FSA) is introduced to investigate lockage safety of LNG-fueled ships. Risk sources during lockage of LNG-fueled ships in four typical scenarios, namely, navigation between two dams, lockage, anchorage, and fueling, are identified, and studied in combination with fundamental leakage probabilities of various components of LNG storage tanks, and simulation results of accident consequences. Some suggestions for lockage safety management of LNG-fueled ships are then proposed. The present research results have certain practical significance for promoting applications of LNG-fueled ships along Chuanjiang River and in Three Gorges Reservoir Region. PMID:28437482

Verification of Emergent Behaviors in Swarm-based Systems

NASA Technical Reports Server (NTRS)

Rouff, Christopher; Vanderbilt, Amy; Hinchey, Mike; Truszkowski, Walt; Rash, James

2004-01-01

The emergent properties of swarms make swarm-based missions powerful, but at the same time more difficult to design and to assure that the proper behaviors will emerge. We are currently investigating formal methods and techniques for verification and validation of swarm-based missions. The Autonomous Nano-Technology Swarm (ANTS) mission is being used as an example and case study for swarm-based missions to experiment and test current formal methods with intelligent swarms. Using the ANTS mission, we have evaluated multiple formal methods to determine their effectiveness in modeling and assuring swarm behavior. This paper introduces how intelligent swarm technology is being proposed for NASA missions, and gives the results of a comparison of several formal methods and approaches for specifying intelligent swarm-based systems and their effectiveness for predicting emergent behavior.

Formal reasoning about systems biology using theorem proving

PubMed Central

Hasan, Osman; Siddique, Umair; Tahar, Sofiène

2017-01-01

System biology provides the basis to understand the behavioral properties of complex biological organisms at different levels of abstraction. Traditionally, analysing systems biology based models of various diseases have been carried out by paper-and-pencil based proofs and simulations. However, these methods cannot provide an accurate analysis, which is a serious drawback for the safety-critical domain of human medicine. In order to overcome these limitations, we propose a framework to formally analyze biological networks and pathways. In particular, we formalize the notion of reaction kinetics in higher-order logic and formally verify some of the commonly used reaction based models of biological networks using the HOL Light theorem prover. Furthermore, we have ported our earlier formalization of Zsyntax, i.e., a deductive language for reasoning about biological networks and pathways, from HOL4 to the HOL Light theorem prover to make it compatible with the above-mentioned formalization of reaction kinetics. To illustrate the usefulness of the proposed framework, we present the formal analysis of three case studies, i.e., the pathway leading to TP53 Phosphorylation, the pathway leading to the death of cancer stem cells and the tumor growth based on cancer stem cells, which is used for the prognosis and future drug designs to treat cancer patients. PMID:28671950

48 CFR 1852.245-73 - Financial reporting of NASA property in the custody of contractors.

Code of Federal Regulations, 2013 CFR

2013-10-01

... due. However, contractors' procedures must document the process for developing these estimates based... shall have formal policies and procedures, which address the validation of NF 1018 data, including data... validation is to ensure that information reported is accurate and in compliance with the NASA FAR Supplement...

48 CFR 1852.245-73 - Financial reporting of NASA property in the custody of contractors.

Code of Federal Regulations, 2012 CFR

2012-10-01

... due. However, contractors' procedures must document the process for developing these estimates based... shall have formal policies and procedures, which address the validation of NF 1018 data, including data... validation is to ensure that information reported is accurate and in compliance with the NASA FAR Supplement...

SU-D-201-07: A Survey of Radiation Oncology Residents’ Training and Preparedness to Lead Patient Safety Programs in Clinics

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

Spraker, M; Nyflot, M; Ford, E

Purpose: Safety and quality has garnered increased attention in radiation oncology, and physicians and physicists are ideal leaders of clinical patient safety programs. However, it is not clear whether residency programs incorporate formal patient safety training and adequately equip residents to assume this leadership role. A national survey was conducted to evaluate medical and physics residents’ exposure to safety topics and their confidence with the skills required to lead clinical safety programs. Methods: Radiation oncology residents were identified in collaboration with ARRO and AAPM. The survey was released in February 2016 via email using REDCap. This included questions about exposuremore » to safety topics, confidence leading safety programs, and interest in training opportunities (i.e. workshops). Residents rated their exposure, skills, and confidence on 4 or 5-point scales. Medical and physics residents responses were compared using chi-square tests. Results: Responses were collected from 56 of 248 (22%) physics and 139 of 690 (20%) medical residents. More than two thirds of all residents had no or only informal exposure to incident learning systems (ILS), root cause analysis (RCA), failure mode and effects analysis (FMEA), and the concept of human factors engineering (HFE). Likewise, 63% of residents had not heard of RO-ILS. Response distributions were similar, however more physics residents had formal exposure to FMEA (p<0.0001) and felt they were adequately trained to lead FMEAs in clinic (p<0.001) than medical residents. Only 36% of residents felt their patient safety training was adequate, and 58% felt more training would benefit their education. Conclusion: These results demonstrate that, despite increasing desire for patient safety training, medical and physics residents’ exposure to relevant concepts is low. Physics residents had more exposure to FMEA than medical residents, and were more confident in leading FMEA. This suggests that increasing resident exposure to specific topics may increase their confidence.« less

Methods and Practices of Investigators for Determining Participants’ Decisional Capacity and Comprehension of Protocols

PubMed Central

Kon, Alexander A.; Klug, Michael

2010-01-01

Ethicists recommend that investigators assess subjects’ comprehension prior to accepting their consent as valid. Because children represent an at-risk population, ensuring adequate comprehension in pediatric research is vital. We surveyed all corresponding authors of research articles published over a six-month period in five leading adult and pediatric journals. Our goal was to assess how often subject’s comprehension or decisional capacity was assessed in the consent process, whether there was any difference between adult and pediatric research projects, and the rate at which investigators use formal or validated tools to assess capacity. Responses from 102 authors were analyzed (response rate 56%). Approximately two-thirds of respondents stated that they assessed comprehension or decisional capacity prior to accepting consent, and we found no difference between adult and pediatric researchers. Nine investigators used a formal questionnaire, and three used a validated tool. These findings suggest that fewer than expected investigators assess comprehension and decisional capacity, and that the use of standardized and validated tools is the exception rather than the rule. PMID:19385838

The development and validation of testing materials for literacy, numeracy and digital skills in a Dutch context

NASA Astrophysics Data System (ADS)

de Greef, Maurice; Segers, Mien; Nijhuis, Jan; Lam, Jo Fond; van Groenestijn, Mieke; van Hoek, Frans; van Deursen, Alexander J. A. M.; Bohnenn, Ella; Tubbing, Marga

2015-10-01

Besides work-oriented training, most Dutch adult learning courses of formal and non-formal education focus on three basic skills: literacy, numeracy and problem solving in technology-rich environments. In the Netherlands, the Ministry of Education, Culture and Science recently initiated the development of a new adult education framework concerning literacy, numeracy and digital skills. In order to monitor the progress of literacy, numeracy and digital competencies, it is necessary to develop and validate testing materials for specific competencies. This study validates the testing materials which were developed to assess learners' proficiency in literacy (reading and writing), numeracy and digital skills based on the new Dutch framework. The outcome is that the materials proved valid and can be used in different courses referring to basic skills and adult learning, though there are still some limitations. Besides adult education professionals (such teachers and trainers), policy makers can also use the results of these tests in order to describe and monitor the impact of adult education on the lives of adult learners.

A Formal Methods Approach to the Analysis of Mode Confusion

NASA Technical Reports Server (NTRS)

Butler, Ricky W.; Miller, Steven P.; Potts, James N.; Carreno, Victor A.

2004-01-01

The goal of the new NASA Aviation Safety Program (AvSP) is to reduce the civil aviation fatal accident rate by 80% in ten years and 90% in twenty years. This program is being driven by the accident data with a focus on the most recent history. Pilot error is the most commonly cited cause for fatal accidents (up to 70%) and obviously must be given major consideration in this program. While the greatest source of pilot error is the loss of situation awareness , mode confusion is increasingly becoming a major contributor as well. The January 30, 1995 issue of Aviation Week lists 184 incidents and accidents involving mode awareness including the Bangalore A320 crash 2/14/90, the Strasbourg A320 crash 1/20/92, the Mulhouse-Habsheim A320 crash 6/26/88, and the Toulouse A330 crash 6/30/94. These incidents and accidents reveal that pilots sometimes become confused about what the cockpit automation is doing. Consequently, human factors research is an obvious investment area. However, even a cursory look at the accident data reveals that the mode confusion problem is much deeper than just training deficiencies and a lack of human-oriented design. This is readily acknowledged by human factors experts. It seems that further progress in human factors must come through a deeper scrutiny of the internals of the automation. It is in this arena that formal methods can contribute. Formal methods refers to the use of techniques from logic and discrete mathematics in the specification, design, and verification of computer systems, both hardware and software. The fundamental goal of formal methods is to capture requirements, designs and implementations in a mathematically based model that can be analyzed in a rigorous manner. Research in formal methods is aimed at automating this analysis as much as possible. By capturing the internal behavior of a flight deck in a rigorous and detailed formal model, the dark corners of a design can be analyzed. This paper will explore how formal models and analyses can be used to help eliminate mode confusion from flight deck designs and at the same time increase our confidence in the safety of the implementation. The paper is based upon interim results from a new project involving NASA Langley and Rockwell Collins in applying formal methods to a realistic business jet Flight Guidance System (FGS).

Modeling the Relationship between Safety Climate and Safety Performance in a Developing Construction Industry: A Cross-Cultural Validation Study

PubMed Central

Zahoor, Hafiz; Chan, Albert P. C.; Utama, Wahyudi P.; Gao, Ran; Zafar, Irfan

2017-01-01

This study attempts to validate a safety performance (SP) measurement model in the cross-cultural setting of a developing country. In addition, it highlights the variations in investigating the relationship between safety climate (SC) factors and SP indicators. The data were collected from forty under-construction multi-storey building projects in Pakistan. Based on the results of exploratory factor analysis, a SP measurement model was hypothesized. It was tested and validated by conducting confirmatory factor analysis on calibration and validation sub-samples respectively. The study confirmed the significant positive impact of SC on safety compliance and safety participation, and negative impact on number of self-reported accidents/injuries. However, number of near-misses could not be retained in the final SP model because it attained a lower standardized path coefficient value. Moreover, instead of safety participation, safety compliance established a stronger impact on SP. The study uncovered safety enforcement and promotion as a novel SC factor, whereas safety rules and work practices was identified as the most neglected factor. The study contributed to the body of knowledge by unveiling the deviations in existing dimensions of SC and SP. The refined model is expected to concisely measure the SP in the Pakistani construction industry, however, caution must be exercised while generalizing the study results to other developing countries. PMID:28350366

Modeling the Relationship between Safety Climate and Safety Performance in a Developing Construction Industry: A Cross-Cultural Validation Study.

PubMed

Zahoor, Hafiz; Chan, Albert P C; Utama, Wahyudi P; Gao, Ran; Zafar, Irfan

2017-03-28

This study attempts to validate a safety performance (SP) measurement model in the cross-cultural setting of a developing country. In addition, it highlights the variations in investigating the relationship between safety climate (SC) factors and SP indicators. The data were collected from forty under-construction multi-storey building projects in Pakistan. Based on the results of exploratory factor analysis, a SP measurement model was hypothesized. It was tested and validated by conducting confirmatory factor analysis on calibration and validation sub-samples respectively. The study confirmed the significant positive impact of SC on safety compliance and safety participation , and negative impact on number of self-reported accidents/injuries . However, number of near-misses could not be retained in the final SP model because it attained a lower standardized path coefficient value. Moreover, instead of safety participation , safety compliance established a stronger impact on SP. The study uncovered safety enforcement and promotion as a novel SC factor, whereas safety rules and work practices was identified as the most neglected factor. The study contributed to the body of knowledge by unveiling the deviations in existing dimensions of SC and SP. The refined model is expected to concisely measure the SP in the Pakistani construction industry, however, caution must be exercised while generalizing the study results to other developing countries.

On the Formal Verification of Conflict Detection Algorithms

NASA Technical Reports Server (NTRS)

Munoz, Cesar; Butler, Ricky W.; Carreno, Victor A.; Dowek, Gilles

2001-01-01

Safety assessment of new air traffic management systems is a main issue for civil aviation authorities. Standard techniques such as testing and simulation have serious limitations in new systems that are significantly more autonomous than the older ones. In this paper, we present an innovative approach, based on formal verification, for establishing the correctness of conflict detection systems. Fundamental to our approach is the concept of trajectory, which is a continuous path in the x-y plane constrained by physical laws and operational requirements. From the Model of trajectories, we extract, and formally prove, high level properties that can serve as a framework to analyze conflict scenarios. We use the Airborne Information for Lateral Spacing (AILS) alerting algorithm as a case study of our approach.

Safety Climate Among Nontraditional Workers in Construction: Arguing for a Focus on Construed External Safety Image.

PubMed

Stiehl, Emily; Forst, Linda

2018-05-01

Safety climate, employees' perceptions of work-related safety, 1 has been promoted as a leading indicator of workplace safety in construction. 2 , 3 While research has primarily examined internal organizational sources (e.g., manager attitudes, formal organizational policies) on these perceptions, external sources of information might be more relevant to construction workers in nontraditional jobs who work for a limited time and/or have limited interaction with other employees. This paper argues for the future development of a construed external safety image scale to measure employees' perceptions about how external groups view their organization's safety. 4 The construed external safety image would capture the external sources that nontraditional workers use to assess safety climate and will allow public health researchers to identify and change dangerous workplaces while more effectively communicating information about safe workplaces to workers. The public health relevance of safety climate and construed external safety image for monitoring and communicating safety to nontraditional workers require examination.

Surgical Safety Training of World Health Organization Initiatives.

PubMed

Davis, Christopher R; Bates, Anthony S; Toll, Edward C; Cole, Matthew; Smith, Frank C T; Stark, Michael

2014-01-01

Undergraduate training in surgical safety is essential to maximize patient safety. This national review quantified undergraduate surgical safety training. Training of 2 international safety initiatives was quantified: (1) World Health Organization (WHO) "Guidelines for Safe Surgery" and (2) Department of Health (DoH) "Principles of the Productive Operating Theatre." Also, 13 additional safety skills were quantified. Data were analyzed using Mann-Whitney U tests. In all, 23 universities entered the study (71.9% response). Safety skills from WHO and DoH documents were formally taught in 4 UK medical schools (17.4%). Individual components of the documents were taught more frequently (47.6%). Half (50.9%) of the additional safety skills identified were taught. Surgical societies supplemented safety training, although the total amount of training provided was less than that in university curricula (P < .0001). Surgical safety training is inadequate in UK medical schools. To protect patients and maximize safety, a national undergraduate safety curriculum is recommended. © 2013 by the American College of Medical Quality.

Factors affecting unsafe behavior in construction projects: development and validation of a new questionnaire.

PubMed

Asilian-Mahabadi, Hassan; Khosravi, Yahya; Hassanzadeh-Rangi, Narmin; Hajizadeh, Ebrahim; Behzadan, Amir H

2018-02-05

Occupational safety in general, and construction safety in particular, is a complex phenomenon. This study was designed to develop a new valid measure to evaluate factors affecting unsafe behavior in the construction industry. A new questionnaire was generated from qualitative research according to the principles of grounded theory. Key measurement properties (face validity, content validity, construct validity, reliability and discriminative validity) were examined using qualitative and quantitative approaches. The receiver operating characteristic curve was used to estimate the discriminating power and the optimal cutoff score. Construct validity revealed an interpretable 12-factor structure which explained 61.87% of variance. Good internal consistency (Cronbach's α = 0.94) and stability (intra-class correlation coefficient = 0.93) were found for the new instrument. The area under the curve, sensitivity and specificity were 0.80, 0.80 and 0.75, respectively. The new instrument also discriminated safety performance among the construction sites with different workers' accident histories (F = 6.40, p < 0.05). The new instrument appears to be a valid, reliable and sensitive instrument that will contribute to investigating the root causes of workers' unsafe behaviors, thus promoting safety performance in the construction industry.

49 CFR 236.905 - Railroad Safety Program Plan (RSPP).

Code of Federal Regulations, 2012 CFR

2012-10-01

... to be used in the verification and validation process, consistent with appendix C to this part. The...; and (iv) The identification of the safety assessment process. (2) Design for verification and validation. The RSPP must require the identification of verification and validation methods for the...

49 CFR 236.905 - Railroad Safety Program Plan (RSPP).

Code of Federal Regulations, 2014 CFR

2014-10-01

... to be used in the verification and validation process, consistent with appendix C to this part. The...; and (iv) The identification of the safety assessment process. (2) Design for verification and validation. The RSPP must require the identification of verification and validation methods for the...

49 CFR 236.905 - Railroad Safety Program Plan (RSPP).

Code of Federal Regulations, 2013 CFR

2013-10-01

... to be used in the verification and validation process, consistent with appendix C to this part. The...; and (iv) The identification of the safety assessment process. (2) Design for verification and validation. The RSPP must require the identification of verification and validation methods for the...

49 CFR 236.905 - Railroad Safety Program Plan (RSPP).

Code of Federal Regulations, 2011 CFR

2011-10-01

... to be used in the verification and validation process, consistent with appendix C to this part. The...; and (iv) The identification of the safety assessment process. (2) Design for verification and validation. The RSPP must require the identification of verification and validation methods for the...

77 FR 50723 - Verification, Validation, Reviews, and Audits for Digital Computer Software Used in Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-22

... Digital Computer Software Used in Safety Systems of Nuclear Power Plants AGENCY: Nuclear Regulatory..., ``Verification, Validation, Reviews, and Audits for Digital Computer Software used in Safety Systems of Nuclear... NRC regulations promoting the development of, and compliance with, software verification and...

Capability maturity models for offshore organisational management.

PubMed

Strutt, J E; Sharp, J V; Terry, E; Miles, R

2006-12-01

The goal setting regime imposed by the UK safety regulator has important implications for an organisation's ability to manage health and safety related risks. Existing approaches to safety assurance based on risk analysis and formal safety assessments are increasingly considered unlikely to create the step change improvement in safety to which the offshore industry aspires and alternative approaches are being considered. One approach, which addresses the important issue of organisational behaviour and which can be applied at a very early stage of design, is the capability maturity model (CMM). The paper describes the development of a design safety capability maturity model, outlining the key processes considered necessary to safety achievement, definition of maturity levels and scoring methods. The paper discusses how CMM is related to regulatory mechanisms and risk based decision making together with the potential of CMM to environmental risk management.

Matching biomedical ontologies based on formal concept analysis.

PubMed

Zhao, Mengyi; Zhang, Songmao; Li, Weizhuo; Chen, Guowei

2018-03-19

The goal of ontology matching is to identify correspondences between entities from different yet overlapping ontologies so as to facilitate semantic integration, reuse and interoperability. As a well developed mathematical model for analyzing individuals and structuring concepts, Formal Concept Analysis (FCA) has been applied to ontology matching (OM) tasks since the beginning of OM research, whereas ontological knowledge exploited in FCA-based methods is limited. This motivates the study in this paper, i.e., to empower FCA with as much as ontological knowledge as possible for identifying mappings across ontologies. We propose a method based on Formal Concept Analysis to identify and validate mappings across ontologies, including one-to-one mappings, complex mappings and correspondences between object properties. Our method, called FCA-Map, incrementally generates a total of five types of formal contexts and extracts mappings from the lattices derived. First, the token-based formal context describes how class names, labels and synonyms share lexical tokens, leading to lexical mappings (anchors) across ontologies. Second, the relation-based formal context describes how classes are in taxonomic, partonomic and disjoint relationships with the anchors, leading to positive and negative structural evidence for validating the lexical matching. Third, the positive relation-based context can be used to discover structural mappings. Afterwards, the property-based formal context describes how object properties are used in axioms to connect anchor classes across ontologies, leading to property mappings. Last, the restriction-based formal context describes co-occurrence of classes across ontologies in anonymous ancestors of anchors, from which extended structural mappings and complex mappings can be identified. Evaluation on the Anatomy, the Large Biomedical Ontologies, and the Disease and Phenotype track of the 2016 Ontology Alignment Evaluation Initiative campaign demonstrates the effectiveness of FCA-Map and its competitiveness with the top-ranked systems. FCA-Map can achieve a better balance between precision and recall for large-scale domain ontologies through constructing multiple FCA structures, whereas it performs unsatisfactorily for smaller-sized ontologies with less lexical and semantic expressions. Compared with other FCA-based OM systems, the study in this paper is more comprehensive as an attempt to push the envelope of the Formal Concept Analysis formalism in ontology matching tasks. Five types of formal contexts are constructed incrementally, and their derived concept lattices are used to cluster the commonalities among classes at lexical and structural level, respectively. Experiments on large, real-world domain ontologies show promising results and reveal the power of FCA.

Strengths, weaknesses, opportunities, and threats analysis of integrating the World Health Organization patient safety curriculum into undergraduate medical education in Pakistan: a qualitative case study.

PubMed

Misbah, Samreen; Mahboob, Usman

2017-01-01

The purpose of this study was to conduct a strengths, weaknesses, opportunities, and threats (SWOT) analysis of integrating the World Health Organization (WHO) patient safety curriculum into undergraduate medical education in Pakistan. A qualitative interpretive case study was conducted at Riphah International University, Islamabad, from October 2016 to June 2017. The study included 9 faculty members and 1 expert on patient safety. The interviews were audiotaped, and a thematic analysis of the transcripts was performed using NVivo software. Four themes were derived based on the need analysis model. The sub-themes derived from the collected data were arranged under the themes of strengths, weaknesses, opportunities, and threats, in accordance with the principles of SWOT analysis. The strengths identified were the need for a formal patient safety curriculum and its early integration into the undergraduate program. The weaknesses were faculty awareness and participation in development programs. The opportunities were an ongoing effort to develop an appropriate curriculum, to improve the current culture of healthcare, and to use the WHO curricular resource guide. The threats were attitudes towards patient safety in Pakistani culture, resistance to implementation from different levels, and the role of regulatory authorities. The theme of patient safety needs to be incorporated early into the formal medical education curriculum, with the main goals of striving to do no harm and seeing mistakes as opportunities to learn. Faculty development activities need to be organized, and faculty members should to be encouraged to participate in them. The lack of a patient safety culture was identified as the primary reason for resistance to this initiative at many levels. The WHO curriculum, amended according to local institutional culture, can be implemented appropriately with support from the corresponding regulatory bodies.

Statechart Analysis with Symbolic PathFinder

NASA Technical Reports Server (NTRS)

Pasareanu, Corina S.

2012-01-01

We report here on our on-going work that addresses the automated analysis and test case generation for software systems modeled using multiple Statechart formalisms. The work is motivated by large programs such as NASA Exploration, that involve multiple systems that interact via safety-critical protocols and are designed with different Statechart variants. To verify these safety-critical systems, we have developed Polyglot, a framework for modeling and analysis of model-based software written using different Statechart formalisms. Polyglot uses a common intermediate representation with customizable Statechart semantics and leverages the analysis and test generation capabilities of the Symbolic PathFinder tool. Polyglot is used as follows: First, the structure of the Statechart model (expressed in Matlab Stateflow or Rational Rhapsody) is translated into a common intermediate representation (IR). The IR is then translated into Java code that represents the structure of the model. The semantics are provided as "pluggable" modules.

Health policy making through operative actions: a case study of provider capacity reduction in a public safety-net system.

PubMed

Tataw, David B

2014-01-01

This article describes and assesses the implications of policy decisions affecting health provider capacity in the Los Angeles County municipal safety-net health system from 1980 to 2000. Although never articulated in law or a county ordinance, the county pursued a sustained and discernable policy of cost reductions that affected capacity at King/Drew Medical Center from 1980 to 2000 without the input of beneficiaries or their advocates. Year after year, the county reduced personnel, supplies, and available beds either by reducing formal budgets or through operative actions of facility administrators that prevented the implementation of formally approved expenditures. This policy appears to have undermined the hospital system's mission of providing health services to at-risk populations with nowhere else to go. Decision making during the two decades under study revealed a decision-making pattern that challenged traditional models of policy decision making.

(Finite) statistical size effects on compressive strength.

PubMed

Weiss, Jérôme; Girard, Lucas; Gimbert, Florent; Amitrano, David; Vandembroucq, Damien

2014-04-29

The larger structures are, the lower their mechanical strength. Already discussed by Leonardo da Vinci and Edmé Mariotte several centuries ago, size effects on strength remain of crucial importance in modern engineering for the elaboration of safety regulations in structural design or the extrapolation of laboratory results to geophysical field scales. Under tensile loading, statistical size effects are traditionally modeled with a weakest-link approach. One of its prominent results is a prediction of vanishing strength at large scales that can be quantified in the framework of extreme value statistics. Despite a frequent use outside its range of validity, this approach remains the dominant tool in the field of statistical size effects. Here we focus on compressive failure, which concerns a wide range of geophysical and geotechnical situations. We show on historical and recent experimental data that weakest-link predictions are not obeyed. In particular, the mechanical strength saturates at a nonzero value toward large scales. Accounting explicitly for the elastic interactions between defects during the damage process, we build a formal analogy of compressive failure with the depinning transition of an elastic manifold. This critical transition interpretation naturally entails finite-size scaling laws for the mean strength and its associated variability. Theoretical predictions are in remarkable agreement with measurements reported for various materials such as rocks, ice, coal, or concrete. This formalism, which can also be extended to the flowing instability of granular media under multiaxial compression, has important practical consequences for future design rules.

Safety Case Development as an Information Modelling Problem

NASA Astrophysics Data System (ADS)

Lewis, Robert

This paper considers the benefits from applying information modelling as the basis for creating an electronically-based safety case. It highlights the current difficulties of developing and managing large document-based safety cases for complex systems such as those found in Air Traffic Control systems. After a review of current tools and related literature on this subject, the paper proceeds to examine the many relationships between entities that can exist within a large safety case. The paper considers the benefits to both safety case writers and readers from the future development of an ideal safety case tool that is able to exploit these information models. The paper also introduces the idea that the safety case has formal relationships between entities that directly support the safety case argument using a methodology such as GSN, and informal relationships that provide links to direct and backing evidence and to supporting information.

Knowledge-based system verification and validation

NASA Technical Reports Server (NTRS)

Johnson, Sally C.

1990-01-01

The objective of this task is to develop and evaluate a methodology for verification and validation (V&V) of knowledge-based systems (KBS) for space station applications with high reliability requirements. The approach consists of three interrelated tasks. The first task is to evaluate the effectiveness of various validation methods for space station applications. The second task is to recommend requirements for KBS V&V for Space Station Freedom (SSF). The third task is to recommend modifications to the SSF to support the development of KBS using effectiveness software engineering and validation techniques. To accomplish the first task, three complementary techniques will be evaluated: (1) Sensitivity Analysis (Worchester Polytechnic Institute); (2) Formal Verification of Safety Properties (SRI International); and (3) Consistency and Completeness Checking (Lockheed AI Center). During FY89 and FY90, each contractor will independently demonstrate the user of his technique on the fault detection, isolation, and reconfiguration (FDIR) KBS or the manned maneuvering unit (MMU), a rule-based system implemented in LISP. During FY91, the application of each of the techniques to other knowledge representations and KBS architectures will be addressed. After evaluation of the results of the first task and examination of Space Station Freedom V&V requirements for conventional software, a comprehensive KBS V&V methodology will be developed and documented. Development of highly reliable KBS's cannot be accomplished without effective software engineering methods. Using the results of current in-house research to develop and assess software engineering methods for KBS's as well as assessment of techniques being developed elsewhere, an effective software engineering methodology for space station KBS's will be developed, and modification of the SSF to support these tools and methods will be addressed.

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

An ORCID based synchronization framework for a national CRIS ecosystem.

PubMed

Mendes Moreira, João; Cunha, Alcino; Macedo, Nuno

2015-01-01

PTCRIS (Portuguese Current Research Information System) is a program aiming at the creation and sustained development of a national integrated information ecosystem, to support research management according to the best international standards and practices. This paper reports on the experience of designing and prototyping a synchronization framework for PTCRIS based on ORCID (Open Researcher and Contributor ID). This framework embraces the "input once, re-use often" principle, and will enable a substantial reduction of the research output management burden by allowing automatic information exchange between the various national systems. The design of the framework followed best practices in rigorous software engineering, namely well-established principles in the research field of consistency management, and relied on formal analysis techniques and tools for its validation and verification. The notion of consistency between the services was formally specified and discussed with the stakeholders before the technical aspects on how to preserve said consistency were explored. Formal specification languages and automated verification tools were used to analyze the specifications and generate usage scenarios, useful for validation with the stakeholder and essential to certificate compliant services.

A Validation Metrics Framework for Safety-Critical Software-Intensive Systems

DTIC Science & Technology

2009-03-01

so does its definition, tools, and techniques, including means for measuring the validation activity, its outputs, and impact on development...independent of the SDLP. When considering the above SDLPs from the safety engineering team’s perspective, there are also large impacts on the way... impact . Interpretation of any actionable metric data will need to be undertaken in the context of the SDLP. 2. Safety Input The software safety

33 CFR 96.360 - Interim Safety Management Certificate: what is it and when can it be used?

Code of Federal Regulations, 2010 CFR

2010-07-01

... section, when— (1) The company's valid Document of Compliance certificate or Interim Document of Compliance certificate applies to that vessel type; (2) The company's safety management system for the vessel... to the responsible person or their company. (b) An Interim Safety Management Certificate is valid for...

Advanced research workshop: nuclear materials safety

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

Jardine, L J; Moshkov, M M

The Advanced Research Workshop (ARW) on Nuclear Materials Safety held June 8-10, 1998, in St. Petersburg, Russia, was attended by 27 Russian experts from 14 different Russian organizations, seven European experts from six different organizations, and 14 U.S. experts from seven different organizations. The ARW was conducted at the State Education Center (SEC), a former Minatom nuclear training center in St. Petersburg. Thirty-three technical presentations were made using simultaneous translations. These presentations are reprinted in this volume as a formal ARW Proceedings in the NATO Science Series. The representative technical papers contained here cover nuclear material safety topics on themore » storage and disposition of excess plutonium and high enriched uranium (HEU) fissile materials, including vitrification, mixed oxide (MOX) fuel fabrication, plutonium ceramics, reprocessing, geologic disposal, transportation, and Russian regulatory processes. This ARW completed discussions by experts of the nuclear materials safety topics that were not covered in the previous, companion ARW on Nuclear Materials Safety held in Amarillo, Texas, in March 1997. These two workshops, when viewed together as a set, have addressed most nuclear material aspects of the storage and disposition operations required for excess HEU and plutonium. As a result, specific experts in nuclear materials safety have been identified, know each other from their participation in t he two ARW interactions, and have developed a partial consensus and dialogue on the most urgent nuclear materials safety topics to be addressed in a formal bilateral program on t he subject. A strong basis now exists for maintaining and developing a continuing dialogue between Russian, European, and U.S. experts in nuclear materials safety that will improve the safety of future nuclear materials operations in all the countries involved because of t he positive synergistic effects of focusing these diverse backgrounds of nuclear experience on a common objectiveÑthe safe and secure storage and disposition of excess fissile nuclear materials.« less

POSNA Quality Safety Value Initiative: From Vision to Implementation to Early Results.

PubMed

Waters, Peter M; Flynn, John M

2015-01-01

The POSNA Quality, Safety and Value Initiative (QSVI) formally started with POSNA board approval in early 2011. The initial vision statement was: "To lead in defining our members' value based clinical care. To partner with hospital based and orthopedic organizational efforts to guarantee safe, high quality outcomes for our patients. To communicate our initiatives and results cooperatively with payer, credentialing, and compliance organizations to improve pediatric orthopedic care in North America."

Expanding the frontiers of national qualifications frameworks through lifelong learning

NASA Astrophysics Data System (ADS)

Owusu-Agyeman, Yaw

2017-10-01

The adoption of a national qualifications framework (NQF) by some governments in all world regions has shown some success in the area of formal learning. However, while NQFs continue to enhance formal learning in many countries, the same cannot be said for the recognition, validation and accreditation (RVA) of non-formal and informal learning. Focusing on competency-based technical and vocational education and training (TVET) within its NQF, Ghana introduced the National Technical and Vocational Education and Training Qualifications Framework (NTVETQF) as a sub-framework in 2012. In the wake of the NTVETQF's limited success, the author of this article reasons that a lifelong learning approach could enhance its effectiveness considerably. Comparing national and international policies, he argues that the NTVETQF should be able to properly address the issues of progression from informal and non-formal to formal modes of lifelong learning within the country's broad context of education. In addition, the study conceptualises the integration of lifelong learning within a broad NQF in four key domains: (1) individual; (2) institutional; (3) industry; and (4) state. The author concludes that, for the NTVETQF to achieve its goal of facilitating access to further education and training while also promoting lifelong learning for all (including workers in the informal economy), effective integration of all modes of lifelong learning is required. Although this entails some challenges, such as recognition of prior learning and validation of all modes of learning, it will help to widen access to education as well as providing individuals with a pathway for achieving their educational aspirations.

Should Student Evaluation of Teaching Play a Significant Role in the Formal Assessment of Dental Faculty? Two Viewpoints: Viewpoint 1: Formal Faculty Assessment Should Include Student Evaluation of Teaching and Viewpoint 2: Student Evaluation of Teaching Should Not Be Part of Formal Faculty Assessment.

PubMed

Rowan, Susan; Newness, Elmer J; Tetradis, Sotirios; Prasad, Joanne L; Ko, Ching-Chang; Sanchez, Arlene

2017-11-01

Student evaluation of teaching (SET) is often used in the assessment of faculty members' job performance and promotion and tenure decisions, but debate over this use of student evaluations has centered on the validity, reliability, and application of the data in assessing teaching performance. Additionally, the fear of student criticism has the potential of influencing course content delivery and testing measures. This Point/Counterpoint article reviews the potential utility of and controversy surrounding the use of SETs in the formal assessment of dental school faculty. Viewpoint 1 supports the view that SETs are reliable and should be included in those formal assessments. Proponents of this opinion contend that SETs serve to measure a school's effectiveness in support of its core mission, are valid measures based on feedback from the recipients of educational delivery, and provide formative feedback to improve faculty accountability to the institution. Viewpoint 2 argues that SETs should not be used for promotion and tenure decisions, asserting that higher SET ratings do not correlate with improved student learning. The advocates of this viewpoint contend that faculty members may be influenced to focus on student satisfaction rather than pedagogy, resulting in grade inflation. They also argue that SETs are prone to gender and racial biases and that SET results are frequently misinterpreted by administrators. Low response rates and monotonic response patterns are other factors that compromise the reliability of SETs.

Can Regulatory Bodies Expect Efficient Help from Formal Methods?

NASA Technical Reports Server (NTRS)

Lopez Ruiz, Eduardo R.; Lemoine, Michel

2010-01-01

In the context of EDEMOI - a French national project that proposed the use of semiformal and formal methods to infer the consistency and robustness of aeronautical regulations through the analysis of faithfully representative models- a methodology had been suggested (and applied) to different (safety and security-related) aeronautical regulations. This paper summarizes the preliminary results of this experience by stating which were the methodology s expected benefits, from a scientific point of view, and which are its useful benefits, from a regulatory body s point of view.

Development of a Software Safety Process and a Case Study of Its Use

NASA Technical Reports Server (NTRS)

Knight, J. C.

1996-01-01

Research in the year covered by this reporting period has been primarily directed toward: continued development of mock-ups of computer screens for operator of a digital reactor control system; development of a reactor simulation to permit testing of various elements of the control system; formal specification of user interfaces; fault-tree analysis including software; evaluation of formal verification techniques; and continued development of a software documentation system. Technical results relating to this grant and the remainder of the principal investigator's research program are contained in various reports and papers.

The Development and Validation of the Inventory of Family Protective Factors: A Brief Assessment for Family Counseling

ERIC Educational Resources Information Center

Gardner, Deborah L.; Huber, Charles H.; Steiner, Robert; Vazquez, Luis A.; Savage, Todd A.

2008-01-01

This article describes the three-stage protocol employed in development and validation of the Inventory of Family Protective Factors (IFPF), a brief-form formal instrument intended to assess the primary protective factors that contribute to family resilience. Following construction of the instrument, data collections and analyses of a total sample…

External validity of a generic safety climate scale for lone workers across different industries and companies.

PubMed

Lee, Jin; Huang, Yueng-hsiang; Robertson, Michelle M; Murphy, Lauren A; Garabet, Angela; Chang, Wen-Ruey

2014-02-01

The goal of this study was to examine the external validity of a 12-item generic safety climate scale for lone workers in order to evaluate the appropriateness of generalized use of the scale in the measurement of safety climate across various lone work settings. External validity evidence was established by investigating the measurement equivalence (ME) across different industries and companies. Confirmatory factor analysis (CFA)-based and item response theory (IRT)-based perspectives were adopted to examine the ME of the generic safety climate scale for lone workers across 11 companies from the trucking, electrical utility, and cable television industries. Fairly strong evidence of ME was observed for both organization- and group-level generic safety climate sub-scales. Although significant invariance was observed in the item intercepts across the different lone work settings, absolute model fit indices remained satisfactory in the most robust step of CFA-based ME testing. IRT-based ME testing identified only one differentially functioning item from the organization-level generic safety climate sub-scale, but its impact was minimal and strong ME was supported. The generic safety climate scale for lone workers reported good external validity and supported the presence of a common feature of safety climate among lone workers. The scale can be used as an effective safety evaluation tool in various lone work situations. Copyright © 2013 Elsevier Ltd. All rights reserved.

Supervisor Health and Safety Support: Scale Development and Validation

PubMed Central

Butts, Marcus M.; Hurst, Carrie S.; Eby, Lillian T.

2013-01-01

Executive Summary Two studies were conducted to develop a psychometrically sound measure of supervisor health and safety support (SHSS). We identified three dimensions of supervisor support (physical health, psychological health, safety) and used Study 1 to develop items and establish content validity. Study 2 was used to establish the dimensionality of the new measure and provide criterion-related and discriminant validity evidence of the measure using supervisor and subordinate data. The measure had incremental validity in predicting employee performance and psychological strain outcomes above and beyond general work support variables. Implications of these findings and for workplace support theory and practice are discussed. PMID:24771991

Understanding visualization: a formal approach using category theory and semiotics.

PubMed

Vickers, Paul; Faith, Joe; Rossiter, Nick

2013-06-01

This paper combines the vocabulary of semiotics and category theory to provide a formal analysis of visualization. It shows how familiar processes of visualization fit the semiotic frameworks of both Saussure and Peirce, and extends these structures using the tools of category theory to provide a general framework for understanding visualization in practice, including: Relationships between systems, data collected from those systems, renderings of those data in the form of representations, the reading of those representations to create visualizations, and the use of those visualizations to create knowledge and understanding of the system under inspection. The resulting framework is validated by demonstrating how familiar information visualization concepts (such as literalness, sensitivity, redundancy, ambiguity, generalizability, and chart junk) arise naturally from it and can be defined formally and precisely. This paper generalizes previous work on the formal characterization of visualization by, inter alia, Ziemkiewicz and Kosara and allows us to formally distinguish properties of the visualization process that previous work does not.

Improving postapproval drug safety surveillance: getting better information sooner.

PubMed

Hennessy, Sean; Strom, Brian L

2015-01-01

Adverse drug events (ADEs) are an important public health concern, accounting for 5% of all hospital admissions and two-thirds of all complications occurring shortly after hospital discharge. There are often long delays between when a drug is approved and when serious ADEs are identified. Recent and ongoing advances in drug safety surveillance include the establishment of government-sponsored networks of population databases, the use of data mining approaches, and the formal integration of diverse sources of drug safety information. These advances promise to reduce delays in identifying drug-related risks and in providing reassurance about the absence of such risks.

Employee Safety Motivation: perspectives and measures on the basis of the Self-Determination theory.

PubMed

Mariani, M G; Soldà, Bianca Lara; Curcuruto, M

2015-09-09

There is a growing body of literature demonstrating that employee's safety behaviour is largely influenced by their motivation to work safely. The Self-Determination Theory, which proposes a multidimensional conceptualization of motivation, is now established in various domains of the academic field (Healthcare, Education, Psychopathology, Organizations, Sport etc.). However, there are few publications concerning its use in the analysis of motivation in a safety context, where it constitutes a new topic of study. The aim of this study was to develop and validate the Italian version of the Self-Determined Safety Motivation Scale and analyze the psychometric properties of the scale in terms of construct validity. The research involved 387 Italian employees from three companies, who occupied medium-low levels in the organizational hierarchy. A good level of psychometric properties was shown. The Italian version of the Self-Determined Safety Motivation Scale is a reliable and valid instrument to assess safety motivation.

Extension of loop quantum gravity to f(R) theories.

PubMed

Zhang, Xiangdong; Ma, Yongge

2011-04-29

The four-dimensional metric f(R) theories of gravity are cast into connection-dynamical formalism with real su(2) connections as configuration variables. Through this formalism, the classical metric f(R) theories are quantized by extending the loop quantization scheme of general relativity. Our results imply that the nonperturbative quantization procedure of loop quantum gravity is valid not only for general relativity but also for a rather general class of four-dimensional metric theories of gravity.

Advanced orbiting systems test-bedding and protocol verification

NASA Technical Reports Server (NTRS)

Noles, James; De Gree, Melvin

1989-01-01

The Consultative Committee for Space Data Systems (CCSDS) has begun the development of a set of protocol recommendations for Advanced Orbiting Systems (SOS). The AOS validation program and formal definition of AOS protocols are reviewed, and the configuration control of the AOS formal specifications is summarized. Independent implementations of the AOS protocols by NASA and ESA are discussed, and cross-support/interoperability tests which will allow the space agencies of various countries to share AOS communication facilities are addressed.

The predictive validity of safety climate.

PubMed

Johnson, Stephen E

2007-01-01

Safety professionals have increasingly turned their attention to social science for insight into the causation of industrial accidents. One social construct, safety climate, has been examined by several researchers [Cooper, M. D., & Phillips, R. A. (2004). Exploratory analysis of the safety climate and safety behavior relationship. Journal of Safety Research, 35(5), 497-512; Gillen, M., Baltz, D., Gassel, M., Kirsch, L., & Vacarro, D. (2002). Perceived safety climate, job Demands, and coworker support among union and nonunion injured construction workers. Journal of Safety Research, 33(1), 33-51; Neal, A., & Griffin, M. A. (2002). Safety climate and safety behaviour. Australian Journal of Management, 27, 66-76; Zohar, D. (2000). A group-level model of safety climate: Testing the effect of group climate on microaccidents in manufacturing jobs. Journal of Applied Psychology, 85(4), 587-596; Zohar, D., & Luria, G. (2005). A multilevel model of safety climate: Cross-level relationships between organization and group-level climates. Journal of Applied Psychology, 90(4), 616-628] who have documented its importance as a factor explaining the variation of safety-related outcomes (e.g., behavior, accidents). Researchers have developed instruments for measuring safety climate and have established some degree of psychometric reliability and validity. The problem, however, is that predictive validity has not been firmly established, which reduces the credibility of safety climate as a meaningful social construct. The research described in this article addresses this problem and provides additional support for safety climate as a viable construct and as a predictive indicator of safety-related outcomes. This study used 292 employees at three locations of a heavy manufacturing organization to complete the 16 item Zohar Safety Climate Questionnaire (ZSCQ) [Zohar, D., & Luria, G. (2005). A multilevel model of safety climate: Cross-level relationships between organization and group-level climates. Journal of Applied Psychology, 90(4), 616-628]. In addition, safety behavior and accident experience data were collected for 5 months following the survey and were statistically analyzed (structural equation modeling, confirmatory factor analysis, exploratory factor analysis, etc.) to identify correlations, associations, internal consistency, and factorial structures. Results revealed that the ZSCQ: (a) was psychometrically reliable and valid, (b) served as an effective predictor of safety-related outcomes (behavior and accident experience), and (c) could be trimmed to an 11 item survey with little loss of explanatory power. Practitioners and researchers can use the ZSCQ with reasonable certainty of the questionnaire's reliability and validity. This provides a solid foundation for the development of meaningful organizational interventions and/or continued research into social factors affecting industrial accident experience.

Are measurements of patient safety culture and adverse events valid and reliable? Results from a cross sectional study.

PubMed

Farup, Per G

2015-05-02

The association between measurements of the patient safety culture and the "true" patient safety has been insufficiently documented, and the validity of the tools used for the measurements has been questioned. This study explored associations between the patient safety culture and adverse events, and evaluated the validity of the tools. In 2008/2009, a survey on patient safety culture was performed with Hospital Survey on Patient Safety Culture (HSOPSC) in two medical departments in two geographically separated hospitals of Innlandet Hospital Trust. Later, a retrospective analysis of adverse events during the same period was performed with the Global Trigger Tool (GTT). The safety culture and adverse events were compared between the departments. 185 employees participated in the study, and 272 patient records were analysed. The HSOPSC scores were lower and adverse events less prevalent in department 1 than in department 2. In departments 1 and 2 the mean HSOPSC scores (SD) were at the unit level 3.62 (0.42) and 3.90 (0.37) (p < 0.001), and at the hospital level 3.35 (1.53) and 3.67 (0.53) (ns, p = 0.19) respectively. The proportion of records with adverse events were 10/135 (7%) and 28/137 (20%) (p = 0.003) respectively. There was an inverse association between the patient safety culture and adverse events. Until the criterion validity of the tools for measuring patient safety culture and tracking of adverse events have been further evaluated, measurement of patient safety culture could not be used as a proxy for the "true" safety.

A Taxonomy of Fallacies in System Safety Arguments

NASA Technical Reports Server (NTRS)

Greenwell, William S.; Knight, John C.; Holloway, C. Michael; Pease, Jacob J.

2006-01-01

Safety cases are gaining acceptance as assurance vehicles for safety-related systems. A safety case documents the evidence and argument that a system is safe to operate; however, logical fallacies in the underlying argument may undermine a system s safety claims. Removing these fallacies is essential to reduce the risk of safety-related system failure. We present a taxonomy of common fallacies in safety arguments that is intended to assist safety professionals in avoiding and detecting fallacious reasoning in the arguments they develop and review. The taxonomy derives from a survey of general argument fallacies and a separate survey of fallacies in real-world safety arguments. Our taxonomy is specific to safety argumentation, and it is targeted at professionals who work with safety arguments but may lack formal training in logic or argumentation. We discuss the rationale for the selection and categorization of fallacies in the taxonomy. In addition to its applications to the development and review of safety cases, our taxonomy could also support the analysis of system failures and promote the development of more robust safety case patterns.

How to Stop Disagreeing and Start Cooperatingin the Presence of Asymmetric Packet Loss.

PubMed

Morales-Ponce, Oscar; Schiller, Elad M; Falcone, Paolo

2018-04-22

We consider the design of a disagreement correction protocol in multi-vehicle systems. Vehicles broadcast in real-time vital information such as position, direction, speed, acceleration, intention, etc. This information is then used to identify the risks and adapt their trajectory to maintain the highest performance without compromising the safety. To minimize the risk due to the use of inconsistent information, all cooperating vehicles must agree whether to use the exchanged information to operate in a cooperative mode or use the only local information to operate in an autonomous mode. However, since wireless communications are prone to failures, it is impossible to deterministically reach an agreement. Therefore, any protocol will exhibit necessary disagreement periods. In this paper, we investigate whether vehicles can still cooperate despite communication failures even in the scenario where communication is suddenly not available. We present a deterministic protocol that allows all participants to either operate a cooperative mode when vehicles can exchange all the information in a timely manner or operate in autonomous mode when messages are lost. We show formally that the disagreement time is bounded by the time that the communication channel requires to deliver messages and validate our protocol using NS-3 simulations. We explain how the proposed solution can be used in vehicular platooning to attain high performance and still guarantee high safety standards despite communication failures.

Scientific advancement of novel protein allergenicity evaluation: an overview of work from the HESI Protein Allergenicity Technical Committee (2000-2008).

PubMed

Thomas, Karluss; MacIntosh, Sue; Bannon, Gary; Herouet-Guicheney, Corinne; Holsapple, Michael; Ladics, Gregory; McClain, Scott; Vieths, Stefan; Woolhiser, Michael; Privalle, Laura

2009-06-01

The safety assessment of genetically modified crops includes the evaluation for potential allergenicity. The current 'state-of-the-science' utilizes a weight of evidence approach, as outlined by the Codex Alimentarius commission (Alinorm 03/34 A), recognizing no single endpoint is predictive of the allergenic potential of a novel protein. This approach evaluates: whether the gene source is allergenic, sequence similarity to known allergens, and protein resistance to pepsin in vitro. If concerns are identified, serological studies may be necessary to determine if a protein has IgE binding similar to known allergens. Since there was a lack of standardized/validated methods to conduct the allergenicity assessment, a committee was assembled under the International Life Sciences Institute Health and Environmental Sciences Institute to address this issue. Over the last eight years, the Protein Allergenicity Technical Committee has convened workshops and symposia with allergy experts and government authorities to refine methods that underpin the assessment for potential protein allergenicity. This publication outlines this ongoing effort, summarizing workshops and formal meetings, referencing publications, and highlighting outreach activities. The purpose is to (1) outline 'the state-of-the-science' in predicting protein allergenicity in the context of current international recommendations for novel protein safety assessment, and (2) identify approaches that can be improved and future research needs.

How to Stop Disagreeing and Start Cooperatingin the Presence of Asymmetric Packet Loss

PubMed Central

2018-01-01

We consider the design of a disagreement correction protocol in multi-vehicle systems. Vehicles broadcast in real-time vital information such as position, direction, speed, acceleration, intention, etc. This information is then used to identify the risks and adapt their trajectory to maintain the highest performance without compromising the safety. To minimize the risk due to the use of inconsistent information, all cooperating vehicles must agree whether to use the exchanged information to operate in a cooperative mode or use the only local information to operate in an autonomous mode. However, since wireless communications are prone to failures, it is impossible to deterministically reach an agreement. Therefore, any protocol will exhibit necessary disagreement periods. In this paper, we investigate whether vehicles can still cooperate despite communication failures even in the scenario where communication is suddenly not available. We present a deterministic protocol that allows all participants to either operate a cooperative mode when vehicles can exchange all the information in a timely manner or operate in autonomous mode when messages are lost. We show formally that the disagreement time is bounded by the time that the communication channel requires to deliver messages and validate our protocol using NS-3 simulations. We explain how the proposed solution can be used in vehicular platooning to attain high performance and still guarantee high safety standards despite communication failures. PMID:29690572

To stand back or step in? Exploring the responses of employees who observe workplace bullying.

PubMed

MacCurtain, Sarah; Murphy, Caroline; O'Sullivan, Michelle; MacMahon, Juliet; Turner, Tom

2018-01-01

Bullying remains a pervasive problem in healthcare, and evidence suggests systems in place are not utilised due to perceptions of ineffectiveness and inequity. This study examines bystander responses to bullying and factors that influence decisions to intervene. We explore relationships between bystanders' perceptions of psychological safety across three levels (organisation, supervisor and colleague) and reactions to witnessing bullying. We suggest psychological safety would be positively associated with the decision to intervene. Findings indicate the most pervasive reaction to witnessing incidents of bullying is to discuss with colleagues, a low-involvement reaction. We find perceptions of supervisory and organisational safety/support are positively related to high-involvement decisions such as formal reporting of the incidents, highlighting the importance of support from those in power. However, perceptions of collegial support may lead to low-involvement responses, which risk reinforcing and underpinning dysfunctional organisational dynamics by providing informal social and emotional responses that may substitute more formal organisational responses to this persistent problem. This study highlights the importance of support from individuals in power if bystanders are to feel comfortable making high-involvement interventions. © 2017 John Wiley & Sons Ltd.

Real-time logic modelling on SpaceWire

NASA Astrophysics Data System (ADS)

Zhou, Qiang; Ma, Yunpeng; Fei, Haidong; Wang, Xingyou

2017-04-01

A SpaceWire is a standard for on-board satellite networks as the basis for future data-handling architectures. However, it cannot meet the deterministic requirement for safety/time critical application in spacecraft, where the delay of real-time (RT) message streams must be guaranteed. Therefore, SpaceWire-D is developed that provides deterministic delivery over a SpaceWire network. Formal analysis and verification of real-time systems is critical to their development and safe implementation, and is a prerequisite for obtaining their safety certification. Failure to meet specified timing constraints such as deadlines in hard real-time systems may lead to catastrophic results. In this paper, a formal verification method, Real-Time Logic (RTL), has been proposed to specify and verify timing properties of SpaceWire-D network. Based on the principal of SpaceWire-D protocol, we firstly analyze the timing properties of fundamental transactions, such as RMAP WRITE, and RMAP READ. After that, the RMAP WRITE transaction structure is modeled in Real-Time Logic (RTL) and Presburger Arithmetic representations. And then, the associated constraint graph and safety analysis is provided. Finally, it is suggested that RTL method can be useful for the protocol evaluation and provision of recommendation for further protocol evolutions.

78 FR 1162 - Cardiovascular Devices; Reclassification of External Cardiac Compressor

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-08

... safety and electromagnetic compatibility; For devices containing software, software verification... electromagnetic compatibility; For devices containing software, software verification, validation, and hazard... electrical components, appropriate analysis and testing must validate electrical safety and electromagnetic...

A psychometric evaluation of the Chinese version of the nursing home survey on patient safety culture.

PubMed

Lin, Shu-Yuan; Tseng, Wei Ting; Hsu, Miao-Ju; Chiang, Hui-Ying; Tseng, Hui-Chen

2017-12-01

To test the psychometric properties of the Chinese version of the Nursing Home Survey on Patient Safety Culture scale among staff in long-term care facilities. The Nursing Home Survey on Patient Safety Culture scale is a standard tool for safety culture assessment in nursing homes. Extending its application to different types of long-term care facilities and varied ethnic populations is worth pursuing. A national random survey. A total of 306 managers and staff completed the Chinese version of the Nursing Home Survey on Patient Safety Culture scale among 30 long-term care facilities in Taiwan. Content validity and construct validity were tested by content validity index (CVI) and principal axis factor analysis (PAF) with Promax rotation. Concurrent validity was tested through correlations between the scale and two overall rating items. Reliability was computed by intraclass correlation coefficient and Cronbach's α coefficients. Statistical analyses such as descriptive, Pearson's and Spearman's rho correlations and PAF were completed. Scale-level and item-level CVIs (0.91-0.98) of the Chinese version of the Nursing Home Survey on Patient Safety Culture scale were satisfactory. Four-factor construct and merged item composition differed from the Nursing Home Survey on Patient Safety Culture scale, and it accounted for 53% of variance. Concurrent validity was evident by existing positive correlations between the scale and two overall ratings of resident safety. Cronbach's α coefficients of the subscales and the Chinese version of the Nursing Home Survey on Patient Safety Culture scale ranged from .76-.94. The Chinese version of the Nursing Home Survey on Patient Safety Culture scale identified essential dimensions to reflect the important features of a patient safety culture in long-term care facilities. The researchers introduced the Chinese version of the Nursing Home Survey on Patient Safety Culture for safety culture assessment in long-term care facilities, but further testing of the reliability of the scale in a large Chinese sample and in different long-term care facilities was recommended. The Chinese version of the Nursing Home Survey on Patient Safety Culture scale was developed to increase the users' intention towards safety culture assessment. It can identify areas for improvement, understand safety culture changes over time and evaluate the effectiveness of interventions. © 2017 John Wiley & Sons Ltd.

An Advisory Committee for the Regulation of Innovation in Gynaecologic Practice: Development and Implementation.

PubMed

Farrell, Scott A; Van Eyk, Nancy

2016-08-01

The fundamental precepts that underpin the delivery of all medical care are safety and efficacy. Although these precepts, in theory, are accepted without challenge, in many settings where clinical care is delivered, there is a lack of formal oversight necessary to ensure their implementation in practice. Even though most medical specialties have national bodies that provide guidelines for good medical practice, and hospital accreditation makes reference to dissemination of such guidelines, there is usually not a mechanism to monitor medical uptake and adherence to good practice in the day-to-day delivery of care. Most hospitals require approval by an institutional review board before research protocols can be undertaken, but regional health authorities and hospitals do not usually have formal processes in place to regulate the adoption of new technologies into clinical practice. Recognizing the lack of a formal process at the hospital level to guide and regulate the introduction of new technologies or procedures, we set out to establish an oversight process to fill this gap. A committee was established to oversee innovation in the Gynaecology Division of our hospital. We describe here the establishment of this committee, the tools the committee used, and the processes used for the committee to do its work. We conclude that formal, local oversight of medical innovation is indispensible for ensuring the high standards of medical practice necessary to optimize patient safety. Copyright © 2016 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.

Development of a Software Safety Process and a Case Study of Its Use

NASA Technical Reports Server (NTRS)

Knight, J. C.

1997-01-01

Research in the year covered by this reporting period has been primarily directed toward the following areas: (1) Formal specification of user interfaces; (2) Fault-tree analysis including software; (3) Evaluation of formal specification notations; (4) Evaluation of formal verification techniques; (5) Expanded analysis of the shell architecture concept; (6) Development of techniques to address the problem of information survivability; and (7) Development of a sophisticated tool for the manipulation of formal specifications written in Z. This report summarizes activities under the grant. The technical results relating to this grant and the remainder of the principal investigator's research program are contained in various reports and papers. The remainder of this report is organized as follows. In the next section, an overview of the project is given. This is followed by a summary of accomplishments during the reporting period and details of students funded. Seminars presented describing work under this grant are listed in the following section, and the final section lists publications resulting from this grant.

Mapping the nomological network of employee self-determined safety motivation: A preliminary measure in China.

PubMed

Jiang, Li; Tetrick, Lois E

2016-09-01

The present study introduced a preliminary measure of employee safety motivation based on the definition of self-determination theory from Fleming (2012) research and validated the structure of self-determined safety motivation (SDSM) by surveying 375 employees in a Chinese high-risk organization. First, confirmatory factor analysis (CFA) was used to examine the factor structure of SDSM, and indices of five-factor model CFA met the requirements. Second, a nomological network was examined to provide evidence of the construct validity of SDSM. Beyond construct validity, the analysis also produced some interesting results concerning the relationship between leadership antecedents and safety motivation, and between safety motivation and safety behavior. Autonomous motivation was positively related to transformational leadership, negatively related to abusive supervision, and positively related to safety behavior. Controlled motivation with the exception of introjected regulation was negatively related to transformational leadership, positively related to abusive supervision, and negatively related to safety behavior. The unique role of introjected regulation and future research based on self-determination theory were discussed. Copyright © 2016 Elsevier Ltd. All rights reserved.

Querying Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Naylor, Dwight; Pai, Ganesh

2014-01-01

Querying a safety case to show how the various stakeholders' concerns about system safety are addressed has been put forth as one of the benefits of argument-based assurance (in a recent study by the Health Foundation, UK, which reviewed the use of safety cases in safety-critical industries). However, neither the literature nor current practice offer much guidance on querying mechanisms appropriate for, or available within, a safety case paradigm. This paper presents a preliminary approach that uses a formal basis for querying safety cases, specifically Goal Structuring Notation (GSN) argument structures. Our approach semantically enriches GSN arguments with domain-specific metadata that the query language leverages, along with its inherent structure, to produce views. We have implemented the approach in our toolset AdvoCATE, and illustrate it by application to a fragment of the safety argument for an Unmanned Aircraft System (UAS) being developed at NASA Ames. We also discuss the potential practical utility of our query mechanism within the context of the existing framework for UAS safety assurance.

A root cause analysis project in a medication safety course.

PubMed

Schafer, Jason J

2012-08-10

To develop, implement, and evaluate team-based root cause analysis projects as part of a required medication safety course for second-year pharmacy students. Lectures, in-class activities, and out-of-class reading assignments were used to develop students' medication safety skills and introduce them to the culture of medication safety. Students applied these skills within teams by evaluating cases of medication errors using root cause analyses. Teams also developed error prevention strategies and formally presented their findings. Student performance was assessed using a medication errors evaluation rubric. Of the 211 students who completed the course, the majority performed well on root cause analysis assignments and rated them favorably on course evaluations. Medication error evaluation and prevention was successfully introduced in a medication safety course using team-based root cause analysis projects.

FRAMEWORK FOR VALIDATION AND IMPLEMENTATION OF IN VITRO TOXICITY TESTS: REPORT OF THE VALIDATION AND TECHNOLOGY TRANSFER COMMITTEE OF THE JOHNS HOPKINS CENTER FOR ALTERNATIVES TO ANIMAL TESTING

EPA Science Inventory

In toxicology the development and application of in vitro alternatives to reduce or replace animal testing, or to lessen the distress and discomfort of laboratory animals, is a rapidly developing trend. owever, at present there is no formal administrative process to organize, coo...

New Coke, Rosetta Stones, and Functional Data Analysis: Recommendations for Developing and Validating New Measures of Depression

ERIC Educational Resources Information Center

Santor, Darcy A.

2006-01-01

In this article, the author outlines six recommendations that may guide the continued development and validation of measures of depression. These are (a) articulate and revise a formal theory of signs and symptoms; (b) differentiate complex theoretical goals from pragmatic evaluation needs; (c) invest heavily in new methods and analytic models;…

Simulation Validation for Societal Systems

DTIC Science & Technology

2006-09-01

of valid inference. Statisticians have developed formal “rules” for inference from quantitative data (Lehmann and Romano 2005). Artificial...time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the...Arlington VA 22202-4302. Respondents should be aware that notwithstanding any other provision of law, no person shall be subject to a penalty for failing

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

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

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

2004-12-01

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

Efficacy testing of cosmetic products. A proposal to the European Community by the Danish Environmental Protection Agency, Ministry of Environment and Energy.

PubMed

Serup, J

2001-08-01

Regulations for cosmetic products primarily address safety of the products that may be used by large populations of healthy consumers. Requirements for documentation of efficacy claims are only fragmentary. This synopsis aims to review and conclude a set of standards that may be acceptable to the European Community, and the cosmetic industry, as a legal standard for efficacy documentation in Europe in the future. Ethical, formal, experimental, statistical and other aspects of efficacy testing are described, including validation, quality control and assurance. The importance of user relevant clinical end points, a controlled randomized trial design and evidence-based cosmetic product documentation, validation of methods, statistical power estimation and proper data handling, reporting and archiving is emphasized. The main principles of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) good clinical practice (GCP) should be followed by the cosmetics industry in a spirit of good documentation standard and scientific soundness, but full GCP is not considered mandatory in the field of cosmetics. Documentation by validated bio-instrumental methods may be acceptable, but efficacy documentation based on information about raw materials, reference to literature and laboratory experiments are only acceptable in exceptional cases. Principles for efficacy substantiation of cosmetic products in Europe, as described in this synopsis, are officially proposed by the Danish Ministry of Environment and Energy to the European Community as a basis for an amendment to the Cosmetics Directive or otherwise implemented as a European Community regulation.

Formalizing Darwinism and inclusive fitness theory.

PubMed

Grafen, Alan

2009-11-12

Inclusive fitness maximization is a basic building block for biological contributions to any theory of the evolution of society. There is a view in mathematical population genetics that nothing is caused to be maximized in the process of natural selection, but this is explained as arising from a misunderstanding about the meaning of fitness maximization. Current theoretical work on inclusive fitness is discussed, with emphasis on the author's 'formal Darwinism project'. Generally, favourable conclusions are drawn about the validity of assuming fitness maximization, but the need for continuing work is emphasized, along with the possibility that substantive exceptions may be uncovered. The formal Darwinism project aims more ambitiously to represent in a formal mathematical framework the central point of Darwin's Origin of Species, that the mechanical processes of inheritance and reproduction can give rise to the appearance of design, and it is a fitting ambition in Darwin's bicentenary year to capture his most profound discovery in the lingua franca of science.

Verification of NASA Emergent Systems

NASA Technical Reports Server (NTRS)

Rouff, Christopher; Vanderbilt, Amy K. C. S.; Truszkowski, Walt; Rash, James; Hinchey, Mike

2004-01-01

NASA is studying advanced technologies for a future robotic exploration mission to the asteroid belt. This mission, the prospective ANTS (Autonomous Nano Technology Swarm) mission, will comprise of 1,000 autonomous robotic agents designed to cooperate in asteroid exploration. The emergent properties of swarm type missions make them powerful, but at the same time are more difficult to design and assure that the proper behaviors will emerge. We are currently investigating formal methods and techniques for verification and validation of future swarm-based missions. The advantage of using formal methods is their ability to mathematically assure the behavior of a swarm, emergent or otherwise. The ANT mission is being used as an example and case study for swarm-based missions for which to experiment and test current formal methods with intelligent swam. Using the ANTS mission, we have evaluated multiple formal methods to determine their effectiveness in modeling and assuring swarm behavior.

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.

Generalized contexts and consistent histories in quantum mechanics

NASA Astrophysics Data System (ADS)

Losada, Marcelo; Laura, Roberto

2014-05-01

We analyze a restriction of the theory of consistent histories by imposing that a valid description of a physical system must include quantum histories which satisfy the consistency conditions for all states. We prove that these conditions are equivalent to imposing the compatibility conditions of our formalism of generalized contexts. Moreover, we show that the theory of consistent histories with the consistency conditions for all states and the formalism of generalized context are equally useful representing expressions which involve properties at different times.

Development and validation of safety climate scales for mobile remote workers using utility/electrical workers as exemplar.

PubMed

Huang, Yueng-Hsiang; Zohar, Dov; Robertson, Michelle M; Garabet, Angela; Murphy, Lauren A; Lee, Jin

2013-10-01

The objective of this study was to develop and test the reliability and validity of a new scale designed for measuring safety climate among mobile remote workers, using utility/electrical workers as exemplar. The new scale employs perceived safety priority as the metric of safety climate and a multi-level framework, separating the measurement of organization- and group-level safety climate items into two sub-scales. The question of the emergence of shared perceptions among remote workers was also examined. For the initial survey development, several items were adopted from a generic safety climate scale and new industry-specific items were generated based on an extensive literature review, expert judgment, 15-day field observations, and 38 in-depth individual interviews with subject matter experts (i.e., utility industry electrical workers, trainers and supervisors of electrical workers). The items were revised after 45 cognitive interviews and a pre-test with 139 additional utility/electrical workers. The revised scale was subsequently implemented with a total of 2421 workers at two large US electric utility companies (1560 participants for the pilot company and 861 for the second company). Both exploratory (EFA) and confirmatory factor analyses (CFA) were adopted to finalize the items and to ensure construct validity. Reliability of the scale was tested based on Cronbach's α. Homogeneity tests examined whether utility/electrical workers' safety climate perceptions were shared within the same supervisor group. This was followed by an analysis of the criterion-related validity, which linked the safety climate scores to self-reports of safety behavior and injury outcomes (i.e., recordable incidents, missing days due to work-related injuries, vehicle accidents, and near misses). Six dimensions (Safety pro-activity, General training, Trucks and equipment, Field orientation, Financial Investment, and Schedule flexibility) with 29 items were extracted from the EFA to measure the organization-level safety climate. Three dimensions (Supervisory care, Participation encouragement, and Safety straight talk) with 19 items were extracted to measure the group-level safety climate. Acceptable ranges of internal consistency statistics for the sub-scales were observed. Whether or not to aggregate these multi-dimensions of safety climate into a single higher-order construct (overall safety climate) was discussed. CFAs confirmed the construct validity of the developed safety climate scale for utility/electrical workers. Homogeneity tests showed that utility/electrical workers' safety climate perceptions were shared within the same supervisor group. Both the organization- and group-level safety climate scores showed a statistically significant relationship with workers' self-reported safety behaviors and injury outcomes. A valid and reliable instrument to measure the essential elements of safety climate for utility/electrical workers in the remote working situation has been introduced. The scale can provide an in-depth understanding of safety climate based on its key dimensions and show where improvements can be made at both group and organization levels. As such, it may also offer a valuable starting point for future safety interventions. Copyright © 2013 Elsevier Ltd. All rights reserved.

First evidence on the validity and reliability of the Safety Organizing Scale-Nursing Home version (SOS-NH).

PubMed

Ausserhofer, Dietmar; Anderson, Ruth A; Colón-Emeric, Cathleen; Schwendimann, René

2013-08-01

The Safety Organizing Scale is a valid and reliable measure on safety behaviors and practices in hospitals. This study aimed to explore the psychometric properties of the Safety Organizing Scale-Nursing Home version (SOS-NH). In a cross-sectional analysis of staff survey data, we examined validity and reliability of the 9-item Safety SOS-NH using American Educational Research Association guidelines. This substudy of a larger trial used baseline survey data collected from staff members (n = 627) in a variety of work roles in 13 nursing homes (NHs) in North Carolina and Virginia. Psychometric evaluation of the SOS-NH revealed good response patterns with low average of missing values across all items (3.05%). Analyses of the SOS-NH's internal structure (eg, comparative fit indices = 0.929, standardized root mean square error of approximation = 0.045) and consistency (composite reliability = 0.94) suggested its 1-dimensionality. Significant between-facility variability, intraclass correlations, within-group agreement, and design effect confirmed appropriateness of the SOS-NH for measurement at the NH level, justifying data aggregation. The SOS-NH showed discriminate validity from one related concept: communication openness. Initial evidence regarding validity and reliability of the SOS-NH supports its utility in measuring safety behaviors and practices among a wide range of NH staff members, including those with low literacy. Further psychometric evaluation should focus on testing concurrent and criterion validity, using resident outcome measures (eg, patient fall rates). Copyright © 2013 American Medical Directors Association, Inc. All rights reserved.

Letter from Administrator Pruitt on Meeting to Reduce Childhood Lead Exposure

EPA Pesticide Factsheets

Administrator Pruitt has formally invited members of the President’s Task Force on Environmental Health Risks and Safety Risks to Children to participate in a meeting to discuss next steps in developing a federal strategy to reduce childhood lead exposure.

31 CFR 1020.100 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... formal banking relationship established to provide or engage in services, dealings, or other financial... of credit. Account also includes a relationship established to provide a safety deposit box or other safekeeping services, or cash management, custodian, and trust services. (2) Account does not include: (i) A...

31 CFR 1020.100 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... formal banking relationship established to provide or engage in services, dealings, or other financial... of credit. Account also includes a relationship established to provide a safety deposit box or other safekeeping services, or cash management, custodian, and trust services. (2) Account does not include: (i) A...

31 CFR 1020.100 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... formal banking relationship established to provide or engage in services, dealings, or other financial... of credit. Account also includes a relationship established to provide a safety deposit box or other safekeeping services, or cash management, custodian, and trust services. (2) Account does not include: (i) A...

31 CFR 1020.100 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... formal banking relationship established to provide or engage in services, dealings, or other financial... of credit. Account also includes a relationship established to provide a safety deposit box or other safekeeping services, or cash management, custodian, and trust services. (2) Account does not include: (i) A...

Safety implications of the use of the flashing yellow arrow for permissive left turns.

DOT National Transportation Integrated Search

2011-01-01

The use of the flashing yellow arrow (FYA) for permissive left turns is relatively new to California, with at least five : installations approved under a 2006 Federal Highway Administration (FHWA) Interim Approval memorandum. : Inclusion of formal gu...

Bibliometrics for Social Validation.

PubMed

Hicks, Daniel J

2016-01-01

This paper introduces a bibliometric, citation network-based method for assessing the social validation of novel research, and applies this method to the development of high-throughput toxicology research at the US Environmental Protection Agency. Social validation refers to the acceptance of novel research methods by a relevant scientific community; it is formally independent of the technical validation of methods, and is frequently studied in history, philosophy, and social studies of science using qualitative methods. The quantitative methods introduced here find that high-throughput toxicology methods are spread throughout a large and well-connected research community, which suggests high social validation. Further assessment of social validation involving mixed qualitative and quantitative methods are discussed in the conclusion.

Bibliometrics for Social Validation

PubMed Central

2016-01-01

This paper introduces a bibliometric, citation network-based method for assessing the social validation of novel research, and applies this method to the development of high-throughput toxicology research at the US Environmental Protection Agency. Social validation refers to the acceptance of novel research methods by a relevant scientific community; it is formally independent of the technical validation of methods, and is frequently studied in history, philosophy, and social studies of science using qualitative methods. The quantitative methods introduced here find that high-throughput toxicology methods are spread throughout a large and well-connected research community, which suggests high social validation. Further assessment of social validation involving mixed qualitative and quantitative methods are discussed in the conclusion. PMID:28005974

Improving the quality of preclinical research echocardiography: Observations, training and guidelines for measurement.

PubMed

Donner, Daniel G; Kiriazis, Helen; Du, Xiao-Jun; Marwick, Thomas H; McMullen, Julie R

2018-04-20

Informal training in preclinical research may be a contributor to the poor reproducibility of preclinical cardiology research and low rates of translation into clinical research and practice. Mouse echocardiography is a widely used technique to assess cardiac structure and function in drug intervention studies using disease models. The inter-observer variability (IOV) of clinical echocardiographic measurements has been shown to improve with formalized training, but preclinical echocardiography lacks similarly critical standardization of training. The aims of this investigation were to assess the IOV of echocardiographic measurements from studies in mice, and address any technical impediments to reproducibility by implementing standardized guidelines through formalized training. In this prospective, single-site, observational cohort study, 13 scientists performing preclinical echocardiographic image analysis were assessed for measurement of short-axis M-mode-derived dimensions and calculated left ventricular mass (LVMass). Ten M-mode images of mouse hearts acquired and analyzed by an expert researcher with a spectrum of LVMass were selected for assessment, and validated by autopsy weight. Following the initial observation, a structured formal training program was introduced, and accuracy and reproducibility were re-evaluated. Mean absolute percentage error (MAPE) for Expert-calculated LVMass was 6{plus minus}4% compared to autopsy LVMass, and 25{plus minus}21% for participants before training. Standardized formal training improved participant MAPE by approximately 30% relative to expert-calculated LVMass (p<0.001). Participants initially categorized with high-range error (25-45%) improved to low-moderate error ranges (<15-25%). This report reveals an example of technical skill training insufficiency likely endemic to preclinical research and provides validated guidelines for echocardiographic measurement for adaptation to formalized in-training programs.

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 which they were originally developed. Mixed methods research to understand why psychometric assessment and measurement reporting practices can be inadequate and lacking in a theoretical basis is also necessary.

[Validity and reliability of the Culture of Quality Health Services questionnaire in Mexico].

PubMed

Herrera-Kiengelher, L; Zepeda-Zaragoza, J; Austria-Corrales, F; Vázquez-Zarate, V M

2013-01-01

Patient Safety is a major public health problem worldwide and is responsibility of all those involved in health care. Establishing a Safety Culture has proved to be a factor that favors the integration of work teams, communication and construction of clear procedures in various organizations. Promote a culture of safety depends on several factors, such as organization, work unit and staff. Objective assessment of these factors will help to identify areas for improvement and establish strategic lines of action. [corrected] To adapt, validate and calibrate the questionnaire Culture of Quality in Health Services (CQHS) in Mexican population. A cross with a stratified representative sample of 522 health workers. The questionnaire was translated and adapted from Singer's. Content was validated by experts, internal consistency, confirmatory factorial validity and item calibration with Samejima's Graded Response Model. Convergent and divergent construct validity was confirmed from the CQHS, item calibration showed that the questionnaire is able to discriminate between patients and represent different levels of the hypothesized dimensions with greater accuracy and lower standard error. The CQHS is a valid and reliable instrument to assess patient safety culture in hospitals in Mexico. Copyright © 2013 SECA. Published by Elsevier Espana. All rights reserved.

Individual safety performance in the construction industry: development and validation of two short scales.

PubMed

DeArmond, Sarah; Smith, April E; Wilson, Christina L; Chen, Peter Y; Cigularov, Konstantin P

2011-05-01

In the current research a short measure of safety performance is developed for use in the construction industry and the relationships between different components of safety performance and safety outcomes (e.g., occupational injuries and work-related pain) are explored within the construction context. This research consists of two field studies. In the first, comprehensive measures of safety compliance and safety participation were shortened and modified to be appropriate for use in construction. Evidence of reliability and validity is provided. Both safety compliance and safety participation were negatively related to occupational injuries, yet these two correlations were not statistically different. In the second study, we investigated the relationships between these two components of safety performance and work-related pain frequency, in addition to replicating Study 1. Safety compliance had a stronger negative relationship with pain than safety participation. Implications for research are discussed. Copyright © 2010 Elsevier Ltd. All rights reserved.

The DSM-5 social anxiety disorder severity scale: Evidence of validity and reliability in a clinical sample.

PubMed

LeBeau, Richard T; Mesri, Bita; Craske, Michelle G

2016-10-30

With DSM-5, the APA began providing guidelines for anxiety disorder severity assessment that incorporates newly developed self-report scales. The scales share a common template, are brief, and are free of copyright restrictions. Initial validation studies have been promising, but the English-language versions of the scales have not been formally validated in clinical samples. Forty-seven individuals with a principal diagnosis of Social Anxiety Disorder (SAD) completed a diagnostic assessment, as well as the DSM-5 SAD severity scale and several previously validated measures. The scale demonstrated internal consistency, convergent validity, and discriminant validity. The next steps in the validation process are outlined. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

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

Not Available

Reflecting Secretary O`Leary`s focus on occupational safety and health, the Office of Occupational Safety is pleased to provide you with the latest update to the DOE Interpretations Guide to OSH Standards. This Guide was developed in cooperation with the Occupational Safety and Health Administration, which continued its support during this last revision by facilitating access to the interpretations found on the OSHA Computerized Information System (OCIS). This March 31, 1994 update contains 123 formal interpretation letters written by OSHA. As a result of the unique requests received by the 1-800 Response Line, this update also contains 38 interpretations developed bymore » DOE. This new occupational safety and health information adds still more important guidance to the four volume reference set that you presently have in your possession.« less

Quantifying and Addressing the DOE Material Reactivity Requirements with Analysis and Testing of Hydrogen Storage Materials & Systems

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

Khalil, Y. F.

2012-04-30

The objective of this project is to examine safety aspects of candidate hydrogen storage materials and systems being developed in the DOE Hydrogen Program. As a result of this effort, the general DOE safety target will be given useful meaning by establishing a link between the characteristics of new storage materials and the satisfaction of safety criteria. This will be accomplished through the development and application of formal risk analysis methods, standardized materials testing, chemical reactivity characterization, novel risk mitigation approaches and subscale system demonstration. The project also will collaborate with other DOE and international activities in materials based hydrogenmore » storage safety to provide a larger, highly coordinated effort.« less

Natural Language Interface for Safety Certification of Safety-Critical Software

NASA Technical Reports Server (NTRS)

Denney, Ewen; Fischer, Bernd

2011-01-01

Model-based design and automated code generation are being used increasingly at NASA. The trend is to move beyond simulation and prototyping to actual flight code, particularly in the guidance, navigation, and control domain. However, there are substantial obstacles to more widespread adoption of code generators in such safety-critical domains. Since code generators are typically not qualified, there is no guarantee that their output is correct, and consequently the generated code still needs to be fully tested and certified. The AutoCert generator plug-in supports the certification of automatically generated code by formally verifying that the generated code is free of different safety violations, by constructing an independently verifiable certificate, and by explaining its analysis in a textual form suitable for code reviews.

Nonstationary oscillations in gyrotrons revisited

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

Dumbrajs, O., E-mail: olgerts.dumbrajs@lu.lv; Kalis, H., E-mail: harijs.kalis@lu.lv

2015-05-15

Development of gyrotrons requires careful understanding of different regimes of gyrotron oscillations. It is known that in the planes of the generalized gyrotron variables: cyclotron resonance mismatch and dimensionless current or cyclotron resonance mismatch and dimensionless interaction length complicated alternating sequences of regions of stationary, periodic, automodulation, and chaotic oscillations exist. In the past, these regions were investigated on the supposition that the transit time of electrons through the interaction space is much shorter than the cavity decay time. This assumption is valid for short and/or high diffraction quality resonators. However, in the case of long and/or low diffraction qualitymore » resonators, which are often utilized, this assumption is no longer valid. In such a case, a different mathematical formalism has to be used for studying nonstationary oscillations. One example of such a formalism is described in the present paper.« less

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

PubMed

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

2012-01-01

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

An overview of health and safety in the Colorado cannabis industry.

PubMed

Walters, Kevin M; Fisher, Gwenith G; Tenney, Liliana

2018-06-01

Understanding worker health and safety in the rapidly growing legal U.S. cannabis industry is important. Although little published research exists, workers may be exposed to biological, chemical, and physical hazards. This study investigated the Colorado cannabis industry workforce and both physical and psychosocial hazards to worker health and safety. Two hundred and fourteen Colorado cannabis workers completed an online survey after in-person and online recruitment. Participants answered questions about their occupation, job tasks, general well-being, occupational health and safety, cannabis use, and tobacco use. Colorado cannabis workers were generally job secure and valued safety. However, they regularly consumed cannabis, expressed low concerns about workplace hazards, reported some occupational injuries and exposures, and reported inconsistent training practices. Working in the cannabis industry is associated with positive outcomes for workers and their organizations, but there is an imminent need to establish formal health and safety training to implement best practices. © 2018 Wiley Periodicals, Inc.

Cockpit automation

NASA Technical Reports Server (NTRS)

Wiener, Earl L.

1988-01-01

The aims and methods of aircraft cockpit automation are reviewed from a human-factors perspective. Consideration is given to the mixed pilot reception of increased automation, government concern with the safety and reliability of highly automated aircraft, the formal definition of automation, and the ground-proximity warning system and accidents involving controlled flight into terrain. The factors motivating automation include technology availability; safety; economy, reliability, and maintenance; workload reduction and two-pilot certification; more accurate maneuvering and navigation; display flexibility; economy of cockpit space; and military requirements.

Use of Unified Modeling Language (UML) in Model-Based Development (MBD) For Safety-Critical Applications

DTIC Science & Technology

2014-12-01

appears that UML is becoming the de facto MBD language. OMG® states the following on the MDA® FAQ page: “Although not formally required [for MBD], UML...a known limitation [42], so UML users should plan accordingly, especially for safety-critical programs. For example, “models are not used to...description of the MBD tool chain can be produced. That description could be resident in a Plan for Software Aspects of Certification (PSAC) or Software

Predictive models of safety based on audit findings: Part 1: Model development and reliability.

PubMed

Hsiao, Yu-Lin; Drury, Colin; Wu, Changxu; Paquet, Victor

2013-03-01

This consecutive study was aimed at the quantitative validation of safety audit tools as predictors of safety performance, as we were unable to find prior studies that tested audit validity against safety outcomes. An aviation maintenance domain was chosen for this work as both audits and safety outcomes are currently prescribed and regulated. In Part 1, we developed a Human Factors/Ergonomics classification framework based on HFACS model (Shappell and Wiegmann, 2001a,b), for the human errors detected by audits, because merely counting audit findings did not predict future safety. The framework was tested for measurement reliability using four participants, two of whom classified errors on 1238 audit reports. Kappa values leveled out after about 200 audits at between 0.5 and 0.8 for different tiers of errors categories. This showed sufficient reliability to proceed with prediction validity testing in Part 2. Copyright © 2012 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Integrated Modeling and Simulation Verification, Validation, and Accreditation Strategy for Exploration Systems Mission Directorate

NASA Technical Reports Server (NTRS)

Hale, Joseph P.

2006-01-01

Models and simulations (M&S) are critical resources in the exploration of space. They support program management, systems engineering, integration, analysis, test, and operations and provide critical information and data supporting key analyses and decisions (technical, cost and schedule). Consequently, there is a clear need to establish a solid understanding of M&S strengths and weaknesses, and the bounds within which they can credibly support decision-making. Their usage requires the implementation of a rigorous approach to verification, validation and accreditation (W&A) and establishment of formal process and practices associated with their application. To ensure decision-making is suitably supported by information (data, models, test beds) from activities (studies, exercises) from M&S applications that are understood and characterized, ESMD is establishing formal, tailored W&A processes and practices. In addition, to ensure the successful application of M&S within ESMD, a formal process for the certification of analysts that use M&S is being implemented. This presentation will highlight NASA's Exploration Systems Mission Directorate (ESMD) management approach for M&S W&A to ensure decision-makers receive timely information on the model's fidelity, credibility, and quality.

Formalizing procedures for operations automation, operator training and spacecraft autonomy

NASA Technical Reports Server (NTRS)

Lecouat, Francois; Desaintvincent, Arnaud

1994-01-01

The generation and validation of operations procedures is a key task of mission preparation that is quite complex and costly. This has motivated the development of software applications providing support for procedures preparation. Several applications have been developed at MATRA MARCONI SPACE (MMS) over the last five years. They are presented in the first section of this paper. The main idea is that if procedures are represented in a formal language, they can be managed more easily with a computer tool and some automatic verifications can be performed. One difficulty is to define a formal language that is easy to use for operators and operations engineers. From the experience of the various procedures management tools developed in the last five years (including the POM, EOA, and CSS projects), MMS has derived OPSMAKER, a generic tool for procedure elaboration and validation. It has been applied to quite different types of missions, ranging from crew procedures (PREVISE system), ground control centers management procedures (PROCSU system), and - most relevant to the present paper - satellite operation procedures (PROCSAT developed for CNES, to support the preparation and verification of SPOT 4 operation procedures, and OPSAT for MMS telecom satellites operation procedures).

Filling the observational void: Scientific value and quantitative validation of hydrometeorological data from a community-based monitoring programme

NASA Astrophysics Data System (ADS)

Walker, David; Forsythe, Nathan; Parkin, Geoff; Gowing, John

2016-07-01

This study shows how community-based hydrometeorological monitoring programmes can provide reliable high-quality measurements comparable to formal observations. Time series of daily rainfall, river stage and groundwater levels obtained by a local community in Dangila woreda, northwest Ethiopia, have passed accepted quality control standards and have been statistically validated against formal sources. In a region of low-density and declining formal hydrometeorological monitoring networks, a situation shared by much of the developing world, community-based monitoring can fill the observational void providing improved spatial and temporal characterisation of rainfall, river flow and groundwater levels. Such time series data are invaluable in water resource assessment and management, particularly where, as shown here, gridded rainfall datasets provide gross under or over estimations of rainfall and where groundwater level data are non-existent. Discussions with the local community during workshops held at the setup of the monitoring programme and since have demonstrated that the community have become engaged in the project and have benefited from a greater hydrological knowledge and sense of ownership of their resources. This increased understanding and empowerment is at the relevant scale required for effective community-based participatory management of shallow groundwater and river catchments.

Formal analysis of imprecise system requirements with Event-B.

PubMed

Le, Hong Anh; Nakajima, Shin; Truong, Ninh Thuan

2016-01-01

Formal analysis of functional properties of system requirements needs precise descriptions. However, the stakeholders sometimes describe the system with ambiguous, vague or fuzzy terms, hence formal frameworks for modeling and verifying such requirements are desirable. The Fuzzy If-Then rules have been used for imprecise requirements representation, but verifying their functional properties still needs new methods. In this paper, we propose a refinement-based modeling approach for specification and verification of such requirements. First, we introduce a representation of imprecise requirements in the set theory. Then we make use of Event-B refinement providing a set of translation rules from Fuzzy If-Then rules to Event-B notations. After that, we show how to verify both safety and eventuality properties with RODIN/Event-B. Finally, we illustrate the proposed method on the example of Crane Controller.

Nurses' attitudes toward continuing formal education: a comparison by level of education and geography.

PubMed

Altmann, Tanya K

2012-01-01

The education of nurses has an influence on patient safety and outcomes, the nursing shortage, the faculty shortage, and nurses' attitudes and actions. This article reports on a dissertation study designed to examine the attitudes of nurses, initially registered with an associate degree or diploma in nursing, toward continuing formal education. Actively licensed registered nurses in the eastern and western United States (n=535) participated. The main finding of this study was that, although nurses held positive attitudes overall, attitudes ranked barely above neutral. The findings suggest that work needs to be done to improve nurses' attitudes toward continuing formal education and research needs to be undertaken to understand what would entice nurses back to school. Implications for nursing practice and education are discussed along with suggestions for future research.

Recognition and Validation of Non Formal and Informal Learning: Lifelong Learning and University in the Italian Context

ERIC Educational Resources Information Center

Di Rienzo, Paolo

2014-01-01

This paper is a reflection, on the basis of empirical research conducted in Italy, on theoretical, methodological and systemic-organisational aspects linked to the recognition and validation of the prior learning acquired by adult learners or workers who decide to enrol at university at a later stage in their lives. The interest in this research…

Threats to the Valid Use of Assessment of Prior Learning in Higher Education: Claimants' Experiences of the Assessment Process

ERIC Educational Resources Information Center

Stenlund, Tova

2012-01-01

Assessment of Prior Learning (APL) refers to a process where adults' prior learning, formal as well as informal, is assessed and acknowledged. In the first section of this paper, APL and current conceptions of validity in assessments and its evaluation are presented. It is argued that participants in the assessment are an important source of…

29 CFR 1902.21 - Tentative decision following formal proceeding.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Section 1902.21 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH..., the Assistant Secretary shall issue a tentative decision either approving or disapproving the plan... therefor on all material issues of fact, law, or discretion which have been presented. The tentative...

10 CFR 1706.6 - Solicitation provisions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Solicitation provisions. 1706.6 Section 1706.6 Energy DEFENSE NUCLEAR FACILITIES SAFETY BOARD ORGANIZATIONAL AND CONSULTANT CONFLICTS OF INTERESTS § 1706.6 Solicitation provisions. (a) Advisory or assistance services. There shall be included in all formal Board...

10 CFR 1706.6 - Solicitation provisions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 4 2012-01-01 2012-01-01 false Solicitation provisions. 1706.6 Section 1706.6 Energy DEFENSE NUCLEAR FACILITIES SAFETY BOARD ORGANIZATIONAL AND CONSULTANT CONFLICTS OF INTERESTS § 1706.6 Solicitation provisions. (a) Advisory or assistance services. There shall be included in all formal Board...

10 CFR 1706.6 - Solicitation provisions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 4 2014-01-01 2014-01-01 false Solicitation provisions. 1706.6 Section 1706.6 Energy DEFENSE NUCLEAR FACILITIES SAFETY BOARD ORGANIZATIONAL AND CONSULTANT CONFLICTS OF INTERESTS § 1706.6 Solicitation provisions. (a) Advisory or assistance services. There shall be included in all formal Board...

10 CFR 1706.6 - Solicitation provisions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 4 2013-01-01 2013-01-01 false Solicitation provisions. 1706.6 Section 1706.6 Energy DEFENSE NUCLEAR FACILITIES SAFETY BOARD ORGANIZATIONAL AND CONSULTANT CONFLICTS OF INTERESTS § 1706.6 Solicitation provisions. (a) Advisory or assistance services. There shall be included in all formal Board...

Obtaining Valid Safety Data for Software Safety Measurement and Process Improvement

NASA Technical Reports Server (NTRS)

Basili, Victor r.; Zelkowitz, Marvin V.; Layman, Lucas; Dangle, Kathleen; Diep, Madeline

2010-01-01

We report on a preliminary case study to examine software safety risk in the early design phase of the NASA Constellation spaceflight program. Our goal is to provide NASA quality assurance managers with information regarding the ongoing state of software safety across the program. We examined 154 hazard reports created during the preliminary design phase of three major flight hardware systems within the Constellation program. Our purpose was two-fold: 1) to quantify the relative importance of software with respect to system safety; and 2) to identify potential risks due to incorrect application of the safety process, deficiencies in the safety process, or the lack of a defined process. One early outcome of this work was to show that there are structural deficiencies in collecting valid safety data that make software safety different from hardware safety. In our conclusions we present some of these deficiencies.

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.

Using process elicitation and validation to understand and improve chemotherapy ordering and delivery.

PubMed

Mertens, Wilson C; Christov, Stefan C; Avrunin, George S; Clarke, Lori A; Osterweil, Leon J; Cassells, Lucinda J; Marquard, Jenna L

2012-11-01

Chemotherapy ordering and administration, in which errors have potentially severe consequences, was quantitatively and qualitatively evaluated by employing process formalism (or formal process definition), a technique derived from software engineering, to elicit and rigorously describe the process, after which validation techniques were applied to confirm the accuracy of the described process. The chemotherapy ordering and administration process, including exceptional situations and individuals' recognition of and responses to those situations, was elicited through informal, unstructured interviews with members of an interdisciplinary team. The process description (or process definition), written in a notation developed for software quality assessment purposes, guided process validation (which consisted of direct observations and semistructured interviews to confirm the elicited details for the treatment plan portion of the process). The overall process definition yielded 467 steps; 207 steps (44%) were dedicated to handling 59 exceptional situations. Validation yielded 82 unique process events (35 new expected but not yet described steps, 16 new exceptional situations, and 31 new steps in response to exceptional situations). Process participants actively altered the process as ambiguities and conflicts were discovered by the elicitation and validation components of the study. Chemotherapy error rates declined significantly during and after the project, which was conducted from October 2007 through August 2008. Each elicitation method and the subsequent validation discussions contributed uniquely to understanding the chemotherapy treatment plan review process, supporting rapid adoption of changes, improved communication regarding the process, and ensuing error reduction.

Applying the lessons of high risk industries to health care.

PubMed

Hudson, P

2003-12-01

High risk industries such as commercial aviation and the oil and gas industry have achieved exemplary safety performance. This paper reviews how they have managed to do that. The primary reasons are the positive attitudes towards safety and the operation of effective formal safety management systems. The safety culture provides an important explanation of why such organisations perform well. An evolutionary model of safety culture is provided in which there is a range of cultures from the pathological through the reactive to the calculative. Later, the proactive culture can evolve towards the generative organisation, an alternative description of the high reliability organisation. The current status of health care is reviewed, arguing that it has a much higher level of accidents and has a reactive culture, lagging behind both high risk industries studied in both attitude and systematic management of patient risks.

Developing and teaching the virtue-ethics foundations of healthcare whistle blowing.

PubMed

Faunce, Thomas

2004-10-01

Healthcare whistle blowing, despite the benefits it has brought to healthcare systems in many developed countries, remains generally regarded as a pariah activity by many of the most influential healthcare professionals and regulatory institutions. Few if any medical schools or law department health law and bioethics classes, teach whistle blowing in a formal sense. Yet without exception, public inquiries initiated by healthcare whistle blowers have validated their central allegations and demonstrated that the whistle blowers themselves were sincere in their desire to implement the fundamental virtues and principles of medical ethics, bioethics and public health law. In many jurisdictions, the law, this time remarkably in advance of professional opinion, has offered legislative protection for reasonable allegations of whistleblowers made in good faith and in the public interest concerning a substantial and imminent threat to public safety. One reason for this paradoxical position, explored here, is that healthcare whistle blowing lacks a firm virtue-based theoretical bioethical and jurisprudential foundation. The hypothesis discussed is that the lack of this bioethical and jurisprudential substrate has contributed to a situation where healthcare whistle blowing suffers in terms of institutional support due to its lack of academic legitimacy. This article commences the process of redressing this imbalance by attempting to lay the theoretical foundations for healthcare whistle blowing. As a case study, this article concludes by discussing the Personal and Professional Development course at the ANU Medical School where healthcare whistle blowing is a formal part of a virtue-based curriculum that emphasises the foundational importance of conscience. Illustrative elements of that program are discussed.

Dismantlement of the TSF-SNAP Reactor Assembly

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

Peretz, Fred J

2009-01-01

This paper describes the dismantlement of the Tower Shielding Facility (TSF)?Systems for Nuclear Auxiliary Power (SNAP) reactor, a SNAP-10A reactor used to validate radiation source terms and shield performance models at Oak Ridge National Laboratory (ORNL) from 1967 through 1973. After shutdown, it was placed in storage at the Y-12 National Security Complex (Y-12), eventually falling under the auspices of the Highly Enriched Uranium (HEU) Disposition Program. To facilitate downblending of the HEU present in the fuel elements, the TSF-SNAP was moved to ORNL on June 24, 2006. The reactor assembly was removed from its packaging, inspected, and the sodium-potassiummore » (NaK) coolant was drained. A superheated steam process was used to chemically react the residual NaK inside the reactor assembly. The heat exchanger assembly was removed from the top of the reactor vessel, and the criticality safety sleeve was exchanged for a new safety sleeve that allowed for the removal of the vessel lid. A chain-mounted tubing cutter was used to separate the lid from the vessel, and the 36 fuel elements were removed and packaged in four U.S. Department of Transportation 2R/6M containers. The fuel elements were returned to Y-12 on July 13, 2006. The return of the fuel elements and disposal of all other reactor materials accomplished the formal objectives of the dismantlement project. In addition, a project model was established for the handling of a fully fueled liquid-metal?cooled reactor assembly. Current criticality safety codes have been benchmarked against experiments performed by Atomics International in the 1950s and 1960s. Execution of this project provides valuable experience applicable to future projects addressing space and liquid-metal-cooled reactors.« less

Investigating and improving pedestrian safety in an urban environment.

PubMed

Pollack, Keshia M; Gielen, Andrea C; Mohd Ismail, Mohd Nasir; Mitzner, Molly; Wu, Michael; Links, Jonathan M

2014-12-01

Prompted by a series of fatal and nonfatal pedestrian-vehicle collisions, university leadership from one urban institution collaborated with its academic injury research center to investigate traffic-related hazards facing pedestrians. This descriptive epidemiologic study used multiple data collection strategies to determine the burden of pedestrian injury in the target area. Data were collected in 2011 through a review of university crash reports from campus police; a systematic environmental audit and direct observations using a validated instrument and trained raters; and focus groups with faculty, students, and staff. Study findings were synthesized and evidence-informed recommendations were developed and disseminated to university leadership. Crash reports provided some indication of the risks on the streets adjacent to the campus. The environmental audit identified a lack of signage posting the speed limit, faded crosswalks, issues with traffic light and walk sign synchronization, and limited formal pedestrian crossings, which led to jaywalking. Focus groups participants described dangerous locations and times, signal controls and signage, enforcement of traffic laws, use of cell phones and iPods, and awareness of pedestrian safety. Recommendations to improve pedestrian safety were developed in accordance with the three E's of injury prevention (education, enforcement, and engineering), and along with plans for implementation and evaluation, were presented to university leadership. These results underscore the importance of using multiple methods to understand fully the problem, developing pragmatic recommendations that align with the three E's of injury prevention, and collaborating with leadership who have the authority to implement recommended injury countermeasures. These lessons are relevant for the many colleges and universities in urban settings where a majority of travel to offices, classrooms, and surrounding amenities are by foot.

A Formal Investigation of Human Spatial Control Skills: Mathematical Formalization, Skill Development, and Skill Assessment

NASA Astrophysics Data System (ADS)

Li, Bin

Spatial control behaviors account for a large proportion of human everyday activities from normal daily tasks, such as reaching for objects, to specialized tasks, such as driving, surgery, or operating equipment. These behaviors involve intensive interactions within internal processes (i.e. cognitive, perceptual, and motor control) and with the physical world. This dissertation builds on a concept of interaction pattern and a hierarchical functional model. Interaction pattern represents a type of behavior synergy that humans coordinates cognitive, perceptual, and motor control processes. It contributes to the construction of the hierarchical functional model that delineates humans spatial control behaviors as the coordination of three functional subsystems: planning, guidance, and tracking/pursuit. This dissertation formalizes and validates these two theories and extends them for the investigation of human spatial control skills encompassing development and assessment. Specifically, this dissertation first presents an overview of studies in human spatial control skills encompassing definition, characteristic, development, and assessment, to provide theoretical evidence for the concept of interaction pattern and the hierarchical functional model. The following, the human experiments for collecting motion and gaze data and techniques to register and classify gaze data, are described. This dissertation then elaborates and mathematically formalizes the hierarchical functional model and the concept of interaction pattern. These theories then enables the construction of a succinct simulation model that can reproduce a variety of human performance with a minimal set of hypotheses. This validates the hierarchical functional model as a normative framework for interpreting human spatial control behaviors. The dissertation then investigates human skill development and captures the emergence of interaction pattern. The final part of the dissertation applies the hierarchical functional model for skill assessment and introduces techniques to capture interaction patterns both from the top down using their geometric features and from the bottom up using their dynamical characteristics. The validity and generality of the skill assessment is illustrated using two the remote-control flight and laparoscopic surgical training experiments.

Pre-surgery briefings and safety climate in the operating theatre.

PubMed

Allard, Jon; Bleakley, Alan; Hobbs, Adrian; Coombes, Lee

2011-08-01

In 2008, the WHO produced a surgical safety checklist against a background of a poor patient safety record in operating theatres. Formal team briefings are now standard practice in high-risk settings such as the aviation industry and improve safety, but are resisted in surgery. Research evidence is needed to persuade the surgical workforce to adopt safety procedures such as briefings. To investigate whether exposure to pre-surgery briefings is related to perception of safety climate. Three Safety Attitude Questionnaires, completed by operating theatre staff in 2003, 2004 and 2006, were used to evaluate the effects of an educational intervention introducing pre-surgery briefings. Individual practitioners who agree with the statement 'briefings are common in the operating theatre' also report a better 'safety climate' in operating theatres. The study reports a powerful link between briefing practices and attitudes towards safety. Findings build on previous work by reporting on the relationship between briefings and safety climate within a 4-year period. Briefings, however, remain difficult to establish in local contexts without appropriate team-based patient safety education. Success in establishing a safety culture, with associated practices, may depend on first establishing unidirectional, positive change in attitudes to create a safety climate.

Strengths, weaknesses, opportunities, and threats analysis of integrating the World Health Organization patient safety curriculum into undergraduate medical education in Pakistan: a qualitative case study

PubMed Central

2017-01-01

Purpose The purpose of this study was to conduct a strengths, weaknesses, opportunities, and threats (SWOT) analysis of integrating the World Health Organization (WHO) patient safety curriculum into undergraduate medical education in Pakistan. Methods A qualitative interpretive case study was conducted at Riphah International University, Islamabad, from October 2016 to June 2017. The study included 9 faculty members and 1 expert on patient safety. The interviews were audiotaped, and a thematic analysis of the transcripts was performed using NVivo software. Results Four themes were derived based on the need analysis model. The sub-themes derived from the collected data were arranged under the themes of strengths, weaknesses, opportunities, and threats, in accordance with the principles of SWOT analysis. The strengths identified were the need for a formal patient safety curriculum and its early integration into the undergraduate program. The weaknesses were faculty awareness and participation in development programs. The opportunities were an ongoing effort to develop an appropriate curriculum, to improve the current culture of healthcare, and to use the WHO curricular resource guide. The threats were attitudes towards patient safety in Pakistani culture, resistance to implementation from different levels, and the role of regulatory authorities. Conclusion The theme of patient safety needs to be incorporated early into the formal medical education curriculum, with the main goals of striving to do no harm and seeing mistakes as opportunities to learn. Faculty development activities need to be organized, and faculty members should to be encouraged to participate in them. The lack of a patient safety culture was identified as the primary reason for resistance to this initiative at many levels. The WHO curriculum, amended according to local institutional culture, can be implemented appropriately with support from the corresponding regulatory bodies. PMID:29284217

Certifying Auto-Generated Flight Code

NASA Technical Reports Server (NTRS)

Denney, Ewen

2008-01-01

Model-based design and automated code generation are being used increasingly at NASA. Many NASA projects now use MathWorks Simulink and Real-Time Workshop for at least some of their modeling and code development. However, there are substantial obstacles to more widespread adoption of code generators in safety-critical domains. Since code generators are typically not qualified, there is no guarantee that their output is correct, and consequently the generated code still needs to be fully tested and certified. Moreover, the regeneration of code can require complete recertification, which offsets many of the advantages of using a generator. Indeed, manual review of autocode can be more challenging than for hand-written code. Since the direct V&V of code generators is too laborious and complicated due to their complex (and often proprietary) nature, we have developed a generator plug-in to support the certification of the auto-generated code. Specifically, the AutoCert tool supports certification by formally verifying that the generated code is free of different safety violations, by constructing an independently verifiable certificate, and by explaining its analysis in a textual form suitable for code reviews. The generated documentation also contains substantial tracing information, allowing users to trace between model, code, documentation, and V&V artifacts. This enables missions to obtain assurance about the safety and reliability of the code without excessive manual V&V effort and, as a consequence, eases the acceptance of code generators in safety-critical contexts. The generation of explicit certificates and textual reports is particularly well-suited to supporting independent V&V. The primary contribution of this approach is the combination of human-friendly documentation with formal analysis. The key technical idea is to exploit the idiomatic nature of auto-generated code in order to automatically infer logical annotations. The annotation inference algorithm itself is generic, and parametrized with respect to a library of coding patterns that depend on the safety policies and the code generator. The patterns characterize the notions of definitions and uses that are specific to the given safety property. For example, for initialization safety, definitions correspond to variable initializations while uses are statements which read a variable, whereas for array bounds safety, definitions are the array declarations, while uses are statements which access an array variable. The inferred annotations are thus highly dependent on the actual program and the properties being proven. The annotations, themselves, need not be trusted, but are crucial to obtain the automatic formal verification of the safety properties without requiring access to the internals of the code generator. The approach has been applied to both in-house and commercial code generators, but is independent of the particular generator used. It is currently being adapted to flight code generated using MathWorks Real-Time Workshop, an automatic code generator that translates from Simulink/Stateflow models into embedded C code.

Elaboration and Validation of the Medication Prescription Safety Checklist 1

PubMed Central

Pires, Aline de Oliveira Meireles; Ferreira, Maria Beatriz Guimarães; do Nascimento, Kleiton Gonçalves; Felix, Márcia Marques dos Santos; Pires, Patrícia da Silva; Barbosa, Maria Helena

2017-01-01

ABSTRACT Objective: to elaborate and validate a checklist to identify compliance with the recommendations for the structure of medication prescriptions, based on the Protocol of the Ministry of Health and the Brazilian Health Surveillance Agency. Method: methodological research, conducted through the validation and reliability analysis process, using a sample of 27 electronic prescriptions. Results: the analyses confirmed the content validity and reliability of the tool. The content validity, obtained by expert assessment, was considered satisfactory as it covered items that represent the compliance with the recommendations regarding the structure of the medication prescriptions. The reliability, assessed through interrater agreement, was excellent (ICC=1.00) and showed perfect agreement (K=1.00). Conclusion: the Medication Prescription Safety Checklist showed to be a valid and reliable tool for the group studied. We hope that this study can contribute to the prevention of adverse events, as well as to the improvement of care quality and safety in medication use. PMID:28793128

Testing the reliability and validity of a measure of safety climate.

PubMed

Anderson, E; McGovern, P M; Kochevar, L; Vesley, D; Gershon, R

2000-01-01

The lack of compliance with universal precautions (UP) is well documented across a wide variety of healthcare professions and has been reported both before and after the enactment of the Occupational Safety and Health Administration's Bloodborne Pathogens Standard. Gershon, Karkashian, and Felknor (1994) found that several factors correlated significantly with healthcare workers' lack of compliance with UP, including a measure of organizational safety climate (e.g., the employees' perception of their organizational culture and practices regarding safety). We conducted a secondary analysis using data from a cross-sectional survey of a convenience sample of 1,746 healthcare workers at risk of occupational exposure to bloodborne pathogens to assess the validity and reliability of Gershon's measure of safety climate. Findings revealed no relationship between safety climate and employees' gender, age, education, tenure in position, profession, hours worked per day, perceived risk, attitude toward risk, and training. An association was demonstrated between safety climate and (1) healthcare worker compliance with UP and (2) the availability of personal protective equipment, providing support for the construct validity of this measure of safety climate. These findings could be used by occupational health professionals to assess employees' perceptions of the safety culture and practices in the workplace and to guide the institution's risk management efforts in association with U.P.

Best practices from WisDOT mega and ARRA projects--request for information : benchmarks and metrics.

DOT National Transportation Integrated Search

2012-03-01

Successful highway construction is measured by cost, time, safety, and quality. One further measure of success is the quantity of Request for Information's (RFI) submitted and their impact. An RFI is a formal written procedure initiated by the contra...

A review of civil aviation fatal accidents in which "lost/disoriented" was a cause/factor : 1981-1990.

DOT National Transportation Integrated Search

1995-01-01

The National Transportation Safety Board (NTSB) analyzes circumstances and data from civil aviation accidents and ascribes one or more causes and/or related factors to help explain each accident. Among the formally accepted NTSB categories of acciden...

Safe surgery: validation of pre and postoperative checklists 1

PubMed Central

Alpendre, Francine Taporosky; Cruz, Elaine Drehmer de Almeida; Dyniewicz, Ana Maria; Mantovani, Maria de Fátima; Silva, Ana Elisa Bauer de Camargo e; dos Santos, Gabriela de Souza

2017-01-01

ABSTRACT Objective: to develop, evaluate and validate a surgical safety checklist for patients in the pre and postoperative periods in surgical hospitalization units. Method: methodological research carried out in a large public teaching hospital in the South of Brazil, with application of the principles of the Safe Surgery Saves Lives Programme of the World Health Organization. The checklist was applied to 16 nurses of 8 surgical units and submitted for validation by a group of eight experts using the Delphi method online. Results: the instrument was validated and it was achieved a mean score ≥1, level of agreement ≥75% and Cronbach’s alpha >0.90. The final version included 97 safety indicators organized into six categories: identification, preoperative, immediate postoperative, immediate postoperative, other surgical complications, and hospital discharge. Conclusion: the Surgical Safety Checklist in the Pre and Postoperative periods is another strategy to promote patient safety, as it allows the monitoring of predictive signs and symptoms of surgical complications and the early detection of adverse events. PMID:28699994

Annual Report To Congress. Department of Energy Activities Relating to the Defense Nuclear Facilities Safety Board, Calendar Year 2003

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

None, None

2004-02-28

The Department of Energy (Department) submits an Annual Report to Congress each year detailing the Department’s activities relating to the Defense Nuclear Facilities Safety Board (Board), which provides advice and recommendations to the Secretary of Energy (Secretary) regarding public health and safety issues at the Department’s defense nuclear facilities. In 2003, the Department continued ongoing activities to resolve issues identified by the Board in formal recommendations and correspondence, staff issue reports pertaining to Department facilities, and public meetings and briefings. Additionally, the Department is implementing several key safety initiatives to address and prevent safety issues: safety culture and review ofmore » the Columbia accident investigation; risk reduction through stabilization of excess nuclear materials; the Facility Representative Program; independent oversight and performance assurance; the Federal Technical Capability Program (FTCP); executive safety initiatives; and quality assurance activities. The following summarizes the key activities addressed in this Annual Report.« less

Agile Methods for Open Source Safety-Critical Software

PubMed Central

Enquobahrie, Andinet; Ibanez, Luis; Cheng, Patrick; Yaniv, Ziv; Cleary, Kevin; Kokoori, Shylaja; Muffih, Benjamin; Heidenreich, John

2011-01-01

The introduction of software technology in a life-dependent environment requires the development team to execute a process that ensures a high level of software reliability and correctness. Despite their popularity, agile methods are generally assumed to be inappropriate as a process family in these environments due to their lack of emphasis on documentation, traceability, and other formal techniques. Agile methods, notably Scrum, favor empirical process control, or small constant adjustments in a tight feedback loop. This paper challenges the assumption that agile methods are inappropriate for safety-critical software development. Agile methods are flexible enough to encourage the right amount of ceremony; therefore if safety-critical systems require greater emphasis on activities like formal specification and requirements management, then an agile process will include these as necessary activities. Furthermore, agile methods focus more on continuous process management and code-level quality than classic software engineering process models. We present our experiences on the image-guided surgical toolkit (IGSTK) project as a backdrop. IGSTK is an open source software project employing agile practices since 2004. We started with the assumption that a lighter process is better, focused on evolving code, and only adding process elements as the need arose. IGSTK has been adopted by teaching hospitals and research labs, and used for clinical trials. Agile methods have matured since the academic community suggested they are not suitable for safety-critical systems almost a decade ago, we present our experiences as a case study for renewing the discussion. PMID:21799545

Agile Methods for Open Source Safety-Critical Software.

PubMed

Gary, Kevin; Enquobahrie, Andinet; Ibanez, Luis; Cheng, Patrick; Yaniv, Ziv; Cleary, Kevin; Kokoori, Shylaja; Muffih, Benjamin; Heidenreich, John

2011-08-01

The introduction of software technology in a life-dependent environment requires the development team to execute a process that ensures a high level of software reliability and correctness. Despite their popularity, agile methods are generally assumed to be inappropriate as a process family in these environments due to their lack of emphasis on documentation, traceability, and other formal techniques. Agile methods, notably Scrum, favor empirical process control, or small constant adjustments in a tight feedback loop. This paper challenges the assumption that agile methods are inappropriate for safety-critical software development. Agile methods are flexible enough to encourage the rightamount of ceremony; therefore if safety-critical systems require greater emphasis on activities like formal specification and requirements management, then an agile process will include these as necessary activities. Furthermore, agile methods focus more on continuous process management and code-level quality than classic software engineering process models. We present our experiences on the image-guided surgical toolkit (IGSTK) project as a backdrop. IGSTK is an open source software project employing agile practices since 2004. We started with the assumption that a lighter process is better, focused on evolving code, and only adding process elements as the need arose. IGSTK has been adopted by teaching hospitals and research labs, and used for clinical trials. Agile methods have matured since the academic community suggested they are not suitable for safety-critical systems almost a decade ago, we present our experiences as a case study for renewing the discussion.

Development and empirical validation of symmetric component measures of multidimensional constructs: customer and competitor orientation.

PubMed

Sørensen, Hans Eibe; Slater, Stanley F

2008-08-01

Atheoretical measure purification may lead to construct deficient measures. The purpose of this paper is to provide a theoretically driven procedure for the development and empirical validation of symmetric component measures of multidimensional constructs. Particular emphasis is placed on establishing a formalized three-step procedure for achieving a posteriori content validity. Then the procedure is applied to development and empirical validation of two symmetrical component measures of market orientation, customer orientation and competitor orientation. Analysis suggests that average variance extracted is particularly critical to reliability in the respecification of multi-indicator measures. In relation to this, the results also identify possible deficiencies in using Cronbach alpha for establishing reliable and valid measures.

Operating manual-based usability evaluation of medical devices: an effective patient safety screening method.

PubMed

Turley, James P; Johnson, Todd R; Smith, Danielle Paige; Zhang, Jaijie; Brixey, Juliana J

2006-04-01

Use of medical devices often directly contributes to medical errors. Because it is difficult or impossible to change the design of existing devices, the best opportunity for improving medical device safety is during the purchasing process. However, most hospital personnel are not familiar with the usability evaluation methods designed to identify aspects of a user interface that do not support intuitive and safe use. A review of medical device operating manuals is proposed as a more practical method of usability evaluation. Operating manuals for five volumetric infusion pumps from three manufacturers were selected for this study (January-April 2003). Each manual's safety message content was evaluated to determine whether the message indicated a device design characteristic that violated known usability principles (heuristics) or indicated a violation of an affordance of the device. "Minimize memory load," with 65 violations, was the heuristic violated most frequently across pumps. Variations between pumps, including the frequency and severity of violations for each, were noted. Results suggest that manual review can provide a proxy for heuristic evaluation of the actual medical device. This method, intended to be a component of prepurchasing evaluation, can complement more formal usability evaluation methods and be used to select a subset of devices for more extensive and formal testing.

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

Linking Recognition Practices and National Qualifications Frameworks: International Benchmarking of Experiences and Strategies on the Recognition, Validation and Accreditation (RVA) of Non-Formal and Informal Learning

ERIC Educational Resources Information Center

Singh, Madhu, Ed.; Duvekot, Ruud, Ed.

2013-01-01

This publication is the outcome of the international conference organized by UNESCO Institute for Lifelong Learning (UIL), in collaboration with the Centre for Validation of Prior Learning at Inholland University of Applied Sciences, the Netherlands, and in partnership with the French National Commission for UNESCO that was held in Hamburg in…

Common Criteria Evaluation and Validation Scheme for Information Technology Security: Guidance to Validators of IT Security Evaluations

DTIC Science & Technology

2002-02-01

NVLAP procedures are compatible with, among others, the most recent official publications of ISO / IEC 17025 (formally ISO / IEC Guide 25), ISO Guides 2, 30... IEC Guide 17025 and the relevant requirements of ISO 9002-1994. NVLAP Handbook 150-20 contains information that is specific to Common Criteria...Evaluation Technical Report EAP Evaluation Acceptance Package IEC International Electrotechnical Commission ISO International

Progression-free survival as surrogate and as true end point: insights from the breast and colorectal cancer literature.

PubMed

Saad, E D; Katz, A; Hoff, P M; Buyse, M

2010-01-01

Significant achievements in the systemic treatment of both advanced breast cancer and advanced colorectal cancer over the past 10 years have led to a growing number of drugs, combinations, and sequences to be tested. The choice of surrogate and true end points has become a critical issue and one that is currently the subject of much debate. Many recent randomized trials in solid tumor oncology have used progression-free survival (PFS) as the primary end point. PFS is an attractive end point because it is available earlier than overall survival (OS) and is not influenced by second-line treatments. PFS is now undergoing validation as a surrogate end point in various disease settings. The question of whether PFS can be considered an acceptable surrogate end point depends not only on formal validation studies but also on a standardized definition and unbiased ascertainment of disease progression in clinical trials. In advanced breast cancer, formal validation of PFS as a surrogate for OS has so far been unsuccessful. In advanced colorectal cancer, in contrast, current evidence indicates that PFS is a valid surrogate for OS after first-line treatment with chemotherapy. The other question is whether PFS sufficiently reflects clinical benefit to be considered a true end point in and of itself.

Model Checking Verification and Validation at JPL and the NASA Fairmont IV and V Facility

NASA Technical Reports Server (NTRS)

Schneider, Frank; Easterbrook, Steve; Callahan, Jack; Montgomery, Todd

1999-01-01

We show how a technology transfer effort was carried out. The successful use of model checking on a pilot JPL flight project demonstrates the usefulness and the efficacy of the approach. The pilot project was used to model a complex spacecraft controller. Software design and implementation validation were carried out successfully. To suggest future applications we also show how the implementation validation step can be automated. The effort was followed by the formal introduction of the modeling technique as a part of the JPL Quality Assurance process.

The formal verification of generic interpreters

NASA Technical Reports Server (NTRS)

Windley, P.; Levitt, K.; Cohen, G. C.

1991-01-01

The task assignment 3 of the design and validation of digital flight control systems suitable for fly-by-wire applications is studied. Task 3 is associated with formal verification of embedded systems. In particular, results are presented that provide a methodological approach to microprocessor verification. A hierarchical decomposition strategy for specifying microprocessors is also presented. A theory of generic interpreters is presented that can be used to model microprocessor behavior. The generic interpreter theory abstracts away the details of instruction functionality, leaving a general model of what an interpreter does.

Formal Verification for a Next-Generation Space Shuttle

NASA Technical Reports Server (NTRS)

Nelson, Stacy D.; Pecheur, Charles; Koga, Dennis (Technical Monitor)

2002-01-01

This paper discusses the verification and validation (V&2) of advanced software used for integrated vehicle health monitoring (IVHM), in the context of NASA's next-generation space shuttle. We survey the current VBCV practice and standards used in selected NASA projects, review applicable formal verification techniques, and discuss their integration info existing development practice and standards. We also describe two verification tools, JMPL2SMV and Livingstone PathFinder, that can be used to thoroughly verify diagnosis applications that use model-based reasoning, such as the Livingstone system.

Noncommutative gauge theories and Kontsevich's formality theorem

NASA Astrophysics Data System (ADS)

Jurčo, B.; Schupp, P.; Wess, J.

2001-09-01

The equivalence of star products that arise from the background field with and without fluctuations and Kontsevich's formality theorem allow an explicitly construction of a map that relates ordinary gauge theory and noncommutative gauge theory (Seiberg-Witten map.) Using noncommutative extra dimensions the construction is extended to noncommutative nonabelian gauge theory for arbitrary gauge groups; as a byproduct we obtain a "Mini Seiberg-Witten map" that explicitly relates ordinary abelian and nonabelian gauge fields. All constructions are also valid for non-constant B-field, and even more generally for any Poisson tensor.

A methodology to migrate the gene ontology to a description logic environment using DAML+OIL.

PubMed

Wroe, C J; Stevens, R; Goble, C A; Ashburner, M

2003-01-01

The Gene Ontology Next Generation Project (GONG) is developing a staged methodology to evolve the current representation of the Gene Ontology into DAML+OIL in order to take advantage of the richer formal expressiveness and the reasoning capabilities of the underlying description logic. Each stage provides a step level increase in formal explicit semantic content with a view to supporting validation, extension and multiple classification of the Gene Ontology. The paper introduces DAML+OIL and demonstrates the activity within each stage of the methodology and the functionality gained.

Executable Architecture Research at Old Dominion University

NASA Technical Reports Server (NTRS)

Tolk, Andreas; Shuman, Edwin A.; Garcia, Johnny J.

2011-01-01

Executable Architectures allow the evaluation of system architectures not only regarding their static, but also their dynamic behavior. However, the systems engineering community do not agree on a common formal specification of executable architectures. To close this gap and identify necessary elements of an executable architecture, a modeling language, and a modeling formalism is topic of ongoing PhD research. In addition, systems are generally defined and applied in an operational context to provide capabilities and enable missions. To maximize the benefits of executable architectures, a second PhD effort introduces the idea of creating an executable context in addition to the executable architecture. The results move the validation of architectures from the current information domain into the knowledge domain and improve the reliability of such validation efforts. The paper presents research and results of both doctoral research efforts and puts them into a common context of state-of-the-art of systems engineering methods supporting more agility.

Knowledge, attitude, and practice of Nigerian commercial motorcyclists in the use of crash helmet and other safety measures.

PubMed

Oginni, Fadekemi O; Ugboko, Vincent I; Adewole, Richard A

2007-06-01

This study was designed to evaluate the knowledge, attitude, and practice of some commercial motorcyclists in Nigeria in the use of crash helmet and other cycling safety measures. At randomly selected commercial motorcycle parks from two South Western Nigerian locations (Lagos and Ile-Ife), we obtained verbal consent from commercial motorcyclists (randomly selected) and thereafter administered structured questionnaires to consenting motorcyclists. The questionnaire sought to know the respondents' biodata (age, gender, and educational attainment inclusive), cycling background, and experience (trainer, duration of training and cycling, and history of crashes). Furthermore, risk factors and practices like alcoholism, maintenance history of the motorcycle, maximum number of pillion passengers carried, and use of crash helmet were elicited. Respondents' knowledge of available safety measures was also investigated. Data was entered into an IBM compatible computer and analyzed using the SPSS 11.0 statistical software. Statistical significance was inferred at p value<0.05. There were 224 male respondents aged 15-58 years. Their peak age was 25-29 years and mean 35.1+/-8.9 years; 8.4% had no formal education; 10.3% received formal training but the majority were either trained by self (35.5%) or an acquaintance (34.6%). Training lasted

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...

9 CFR 417.4 - Validation, Verification, Reassessment.

Code of Federal Regulations, 2012 CFR

2012-01-01

... not have a HACCP plan because a hazard analysis has revealed no food safety hazards that are.... 417.4 Section 417.4 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF... ACT HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS § 417.4 Validation, Verification...

9 CFR 417.4 - Validation, Verification, Reassessment.

Code of Federal Regulations, 2010 CFR

2010-01-01

... not have a HACCP plan because a hazard analysis has revealed no food safety hazards that are.... 417.4 Section 417.4 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF... ACT HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS § 417.4 Validation, Verification...

9 CFR 417.4 - Validation, Verification, Reassessment.

Code of Federal Regulations, 2011 CFR

2011-01-01

... not have a HACCP plan because a hazard analysis has revealed no food safety hazards that are.... 417.4 Section 417.4 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF... ACT HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS § 417.4 Validation, Verification...

Development and validation of a remote home safety protocol.

PubMed

Romero, Sergio; Lee, Mi Jung; Simic, Ivana; Levy, Charles; Sanford, Jon

2018-02-01

Environmental assessments and subsequent modifications conducted by healthcare professionals can enhance home safety and promote independent living. However, travel time, expense and the availability of qualified professionals can limit the broad application of this intervention. Remote technology has the potential to increase access to home safety evaluations. This study describes the development and validation of a remote home safety protocol that can be used by a caregiver of an elderly person to video-record their home environment for later viewing and evaluation by a trained professional. The protocol was developed based on literature reviews and evaluations from clinical and content experts. Cognitive interviews were conducted with a group of six caregivers to validate the protocol. The final protocol included step-by-step directions to record indoor and outdoor areas of the home. The validation process resulted in modifications related to safety, clarity of the protocol, readability, visual appearance, technical descriptions and usability. Our final protocol includes detailed instructions that a caregiver should be able to follow to record a home environment for subsequent evaluation by a home safety professional. Implications for Rehabilitation The results of this study have several implications for rehabilitation practice The remote home safety evaluation protocol can potentially improve access to rehabilitation services for clients in remote areas and prevent unnecessary delays for needed care. Using our protocol, a patient's caregiver can partner with therapists to quickly and efficiently evaluate a patient's home before they are released from the hospital. Caregiver narration, which reflects a caregiver's own perspective, is critical to evaluating home safety. In-home safety evaluations, currently not available to all who need them due to access barriers, can enhance a patient's independence and provide a safer home environment.

The VATES-Diamond as a Verifier's Best Friend

NASA Astrophysics Data System (ADS)

Glesner, Sabine; Bartels, Björn; Göthel, Thomas; Kleine, Moritz

Within a model-based software engineering process it needs to be ensured that properties of abstract specifications are preserved by transformations down to executable code. This is even more important in the area of safety-critical real-time systems where additionally non-functional properties are crucial. In the VATES project, we develop formal methods for the construction and verification of embedded systems. We follow a novel approach that allows us to formally relate abstract process algebraic specifications to their implementation in a compiler intermediate representation. The idea is to extract a low-level process algebraic description from the intermediate code and to formally relate it to previously developed abstract specifications. We apply this approach to a case study from the area of real-time operating systems and show that this approach has the potential to seamlessly integrate modeling, implementation, transformation and verification stages of embedded system development.

Modeling of clover detector in addback mode

NASA Astrophysics Data System (ADS)

Kshetri, R.

2012-07-01

Based on absorption and scattering of gamma-rays, a formalism has been presented for modeling the clover germanium detector in addback mode and to predict its response for high energy γ-rays. In the present formalism, the operation of a bare clover detector could be described in terms of three quantities only. Considering an additional parameter, the formalism could be extended for suppressed clover. Using experimental data on relative single crystal efficiency and addback factor as input, the peak-to-total ratio has been calculated for three energies (Eγ = 3.401, 5.324 and 10.430 MeV) where direct measurement of peak-to-total ratio is impossible due to absence of a radioactive source having single monoenergetic gamma-ray of that energy. The experimental validation and consistency of the formalism have been shown considering data for TIGRESS clover detector. In a recent work (R. Kshetri, JINST 2012 7 P04008), we showed that for a given γ-ray energy, the formalism could be used to predict the peak-to-total ratio as a function of number of detector modules. In the present paper, we have shown that for a given composite detector (clover detector is considered here), the formalism could be used to predict the peak-to-total ratio as a function of γ-ray energy.

Measuring safety culture in Dutch primary care: psychometric characteristics of the SCOPE-PC questionnaire.

PubMed

Verbakel, Natasha J; Zwart, Dorien L M; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula

2013-09-17

Patient safety has been a priority in primary healthcare in the last years. The prevailing culture is seen as an important condition for patient safety in practice and several tools to measure patient safety culture have therefore been developed. Although Dutch primary care consists of different professions, such as general practice, dental care, dietetics, physiotherapy and midwifery, a safety culture questionnaire was only available for general practices. The purpose of this study was to modify and validate this existing questionnaire to a generic questionnaire for all professions in Dutch primary care. A validated Dutch questionnaire for general practices was modified to make it usable for all Dutch primary care professions. Subsequently, this questionnaire was administered to a random sample of 2400 practices from eleven primary care professions. The instrument's factor structure, reliability and validity were examined using confirmatory and explorative factor analyses. 921 questionnaires were returned. Of these, 615 were eligible for factor analysis. The resulting SCOPE-PC questionnaire consisted of seven dimensions: 'open communication and learning from errors', 'handover and teamwork', 'adequate procedures and working conditions', 'patient safety management', 'support and fellowship', 'intention to report events' and 'organisational learning' with a total of 41 items. All dimensions had good reliability with Cronbach's alphas ranging from 0.70-0.90, and the questionnaire had a good construct validity. The SCOPE-PC questionnaire has sound psychometric characteristics for use by the different professions in Dutch primary care to gain insight in their safety culture.

Positive Coping Strategies among Immigrant Cambodian Families: An Ethnographic Case Study.

ERIC Educational Resources Information Center

Reiboldt, Wendy; Goldstein, Avery E.

2000-01-01

Interviews with two Cambodian immigrant families over 2 years revealed how they relied on each other more than formal service providers to cope with difficulties. They focused on children's education and safety, insulation of the family from external influences, and interdependence with the immigrant community. (SK)

Exposure to Hazardous Chemical Substances--A Major Campus Environmental Health & Safety Concern.

ERIC Educational Resources Information Center

Robinson, Donald A.; Sorensen, Alfred J.

1980-01-01

A broad spectrum of potentially hazardous chemicals offers serious exposure risks to members of college and university communities. A formal program is needed to minimize exposure to these substances and maintain a prevention oriented protective program. The University of Massachusetts has developed such a program. (JN)

Safety and fitness electronic records system (SAFER) : draft master test plan

DOT National Transportation Integrated Search

1995-12-31

The purpose of this plan is to establish a formal set of guidelines and activities to be : adhered to and performed by JHU/APL and the developer to ensure that the SAFER System has been tested successfully and is fully compliant with the SAFER System...

The intelligent transportation aystems public safety program : opportunities for technological advancement in detecting, responding and recovering from community emergencies

DOT National Transportation Integrated Search

1993-08-01

This report is the third in a series produced for the Federal Transit Administration (FTA) and the Federal Highway Administration (FHWA) by the Volpe National Transportation Systems Center (Volpe Center). This formal, comprehensive review of the plan...

Combining the GW formalism with the polarizable continuum model: A state-specific non-equilibrium approach

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

Duchemin, Ivan, E-mail: ivan.duchemin@cea.fr; Jacquemin, Denis; Institut Universitaire de France, 1 rue Descartes, 75005 Paris Cedex 5

We have implemented the polarizable continuum model within the framework of the many-body Green’s function GW formalism for the calculation of electron addition and removal energies in solution. The present formalism includes both ground-state and non-equilibrium polarization effects. In addition, the polarization energies are state-specific, allowing to obtain the bath-induced renormalisation energy of all occupied and virtual energy levels. Our implementation is validated by comparisons with ΔSCF calculations performed at both the density functional theory and coupled-cluster single and double levels for solvated nucleobases. The present study opens the way to GW and Bethe-Salpeter calculations in disordered condensed phases ofmore » interest in organic optoelectronics, wet chemistry, and biology.« less

An elementary tutorial on formal specification and verification using PVS

NASA Technical Reports Server (NTRS)

Butler, Ricky W.

1993-01-01

A tutorial on the development of a formal specification and its verification using the Prototype Verification System (PVS) is presented. The tutorial presents the formal specification and verification techniques by way of specific example - an airline reservation system. The airline reservation system is modeled as a simple state machine with two basic operations. These operations are shown to preserve a state invariant using the theorem proving capabilities of PVS. The technique of validating a specification via 'putative theorem proving' is also discussed and illustrated in detail. This paper is intended for the novice and assumes only some of the basic concepts of logic. A complete description of user inputs and the PVS output is provided and thus it can be effectively used while one is sitting at a computer terminal.

Linguistic Validation and Cultural Adaptation of Bulgarian Version of Hospital Survey on Patient Safety Culture (HSOPSC).

PubMed

Stoyanova, Rumyana; Dimova, Rositsa; Tarnovska, Miglena; Boeva, Tatyana

2018-05-20

Patient safety (PS) is one of the essential elements of health care quality and a priority of healthcare systems in most countries. Thus the creation of validated instruments and the implementation of systems that measure patient safety are considered to be of great importance worldwide. The present paper aims to illustrate the process of linguistic validation, cross-cultural verification and adaptation of the Bulgarian version of the Hospital Survey on Patient Safety Culture (B-HSOPSC) and its test-retest reliability. The study design is cross-sectional. The HSOPSC questionnaire consists of 42 questions, grouped in 12 different subscales that measure patient safety culture. Internal con-sistency was assessed using Cronbach's alpha. The Wilcoxon signed-rank test and the split-half method were used; the Spear-man-Brown coefficient was calculated. The overall Cronbach's alpha for B-HSOPSC is 0.918. Subscales 7 Staffing and 12 Overall perceptions of safety had the lowest coefficients. The high reliability of the instrument was confirmed by the Split-half method (0.97) and ICC-coefficient (0.95). The lowest values of Spearmen-Broun coefficients were found in items A13 and A14. The study offers an analysis of the results of the linguistic validation of the B-HSOPSC and its test-retest reliability. The psychometric characteristics of the questions revealed good validity and reliability, except two questions. In the future, the instrument will be administered to the target population in the main study so that the psychometric properties of the instrument can be verified.

A Spanish-language patient safety questionnaire to measure medical and nursing students' attitudes and knowledge.

PubMed

Mira, José J; Navarro, Isabel M; Guilabert, Mercedes; Poblete, Rodrigo; Franco, Astolfo L; Jiménez, Pilar; Aquino, Margarita; Fernández-Trujillo, Francisco J; Lorenzo, Susana; Vitaller, Julián; de Valle, Yohana Díaz; Aibar, Carlos; Aranaz, Jesús M; De Pedro, José A

2015-08-01

To design and validate a questionnaire for assessing attitudes and knowledge about patient safety using a sample of medical and nursing students undergoing clinical training in Spain and four countries in Latin America. In this cross-sectional study, a literature review was carried out and total of 786 medical and nursing students were surveyed at eight universities from five countries (Chile, Colombia, El Salvador, Guatemala, and Spain) to develop and refine a Spanish-language questionnaire on knowledge and attitudes about patient safety. The scope of the questionnaire was based on five dimensions (factors) presented in studies related to patient safety culture found in PubMed and Scopus. Based on the five factors, 25 reactive items were developed. Composite reliability indexes and Cronbach's alpha statistics were estimated for each factor, and confirmatory factor analysis was conducted to assess validity. After a pilot test, the questionnaire was refined using confirmatory models, maximum-likelihood estimation, and the variance-covariance matrix (as input). Multiple linear regression models were used to confirm external validity, considering variables related to patient safety culture as dependent variables and the five factors as independent variables. The final instrument was a structured five-point Likert self-administered survey (the "Latino Student Patient Safety Questionnaire") consisting of 21 items grouped into five factors. Compound reliability indexes (Cronbach's alpha statistic) calculated for the five factors were about 0.7 or higher. The results of the multiple linear regression analyses indicated good model fit (goodness-of-fit index: 0.9). Item-total correlations were higher than 0.3 in all cases. The convergent-discriminant validity was adequate. The questionnaire designed and validated in this study assesses nursing and medical students' attitudes and knowledge about patient safety. This instrument could be used to indirectly evaluate whether or not students in health disciplines are acquiring and thus likely to put into practice the professional skills currently considered most appropriate for patient safety.

Safety-net providers in some US communities have increasingly embraced coordinated care models.

PubMed

Cunningham, Peter; Felland, Laurie; Stark, Lucy

2012-08-01

Safety-net organizations, which provide health services to uninsured and low-income people, increasingly are looking for ways to coordinate services among providers to improve access to and quality of care and to reduce costs. In this analysis, a part of the Community Tracking Study, we examined trends in safety-net coordination activities from 2000 to 2010 within twelve communities in the United States and found a notable increase in such activities. Six of the twelve communities had made formal efforts to link uninsured people to medical homes and coordinate care with specialists in 2010, compared to only two communities in 2000. We also identified key attributes of safety-net coordinated care systems, such as reliance on a medical home for meeting patients' primary care needs, and lingering challenges to safety-net integration, such as competition among hospitals and community health centers for Medicaid patients.

Safety policy and requirements for payloads using the Space Transportation System (STS)

NASA Technical Reports Server (NTRS)

1982-01-01

The Space Transportation Operations (STO) safety policy is to minimize STO involvement in the payload and its GSE (ground support equipment) design process while maintaining the assurance of a safe operation. Requirements for assuring payload mission success are the responsibility of the payload organization and are beyond the scope of this document. The intent is to provide the overall safety policies and requirements while allowing for negotiation between the payload organization and the STO operator in the method of implementation of payload safety. This revision provides for a relaxation in the monitoring requirements for inhibits, allows the payload organization to pursue design options and reflects, additionally, some new requirements. As of the issue date of this NHB, payloads which have completed the formal safety assessment reviews of their preliminary design on the basis of the May 1979 issue will be reassessed for compliance with the above changes.

The role of professional communities in governing patient safety.

PubMed

Turner, Simon; Ramsay, Angus; Fulop, Naomi

2013-01-01

Using the example of medication safety, this paper aims to explore the impact of three managerial interventions (adverse incident reporting, ward-level support by pharmacists, and a medication safety subcommittee) on different professional communities situated in the English National Health Service (NHS). Semi-structured interviews were conducted with clinical and managerial staff from two English NHS acute trusts, supplemented with meeting observations and documentary analysis. Attitudes toward managerial intervention differ by professional community (between doctors, nurses and pharmacists) according to their existing norms of safety and perceptions of formal governance processes. The heterogeneity of social norms across different professional communities and medical specialties has implications for the design of organisational learning mechanisms in the field of patient safety. The paper shows that theorisation of professional "resistance" to managerialism privileges the study of doctors' reactions to management with the consequent neglect of the perceptions of other professional communities.

Applying the lessons of high risk industries to health care

PubMed Central

Hudson, P

2003-01-01

High risk industries such as commercial aviation and the oil and gas industry have achieved exemplary safety performance. This paper reviews how they have managed to do that. The primary reasons are the positive attitudes towards safety and the operation of effective formal safety management systems. The safety culture provides an important explanation of why such organisations perform well. An evolutionary model of safety culture is provided in which there is a range of cultures from the pathological through the reactive to the calculative. Later, the proactive culture can evolve towards the generative organisation, an alternative description of the high reliability organisation. The current status of health care is reviewed, arguing that it has a much higher level of accidents and has a reactive culture, lagging behind both high risk industries studied in both attitude and systematic management of patient risks. PMID:14645741

Modeling patient safety incidents knowledge with the Categorial Structure method.

PubMed

Souvignet, Julien; Bousquet, Cédric; Lewalle, Pierre; Trombert-Paviot, Béatrice; Rodrigues, Jean Marie

2011-01-01

Following the WHO initiative named World Alliance for Patient Safety (PS) launched in 2004 a conceptual framework developed by PS national reporting experts has summarized the knowledge available. As a second step, the Department of Public Health of the University of Saint Etienne team elaborated a Categorial Structure (a semi formal structure not related to an upper level ontology) identifying the elements of the semantic structure underpinning the broad concepts contained in the framework for patient safety. This knowledge engineering method has been developed to enable modeling patient safety information as a prerequisite for subsequent full ontology development. The present article describes the semantic dissection of the concepts, the elicitation of the ontology requirements and the domain constraints of the conceptual framework. This ontology includes 134 concepts and 25 distinct relations and will serve as basis for an Information Model for Patient Safety.

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".

Formalizing Darwinism and inclusive fitness theory

PubMed Central

Grafen, Alan

2009-01-01

Inclusive fitness maximization is a basic building block for biological contributions to any theory of the evolution of society. There is a view in mathematical population genetics that nothing is caused to be maximized in the process of natural selection, but this is explained as arising from a misunderstanding about the meaning of fitness maximization. Current theoretical work on inclusive fitness is discussed, with emphasis on the author's ‘formal Darwinism project’. Generally, favourable conclusions are drawn about the validity of assuming fitness maximization, but the need for continuing work is emphasized, along with the possibility that substantive exceptions may be uncovered. The formal Darwinism project aims more ambitiously to represent in a formal mathematical framework the central point of Darwin's Origin of Species, that the mechanical processes of inheritance and reproduction can give rise to the appearance of design, and it is a fitting ambition in Darwin's bicentenary year to capture his most profound discovery in the lingua franca of science. PMID:19805422

ARIES: Acquisition of Requirements and Incremental Evolution of Specifications

NASA Technical Reports Server (NTRS)

Roberts, Nancy A.

1993-01-01

This paper describes a requirements/specification environment specifically designed for large-scale software systems. This environment is called ARIES (Acquisition of Requirements and Incremental Evolution of Specifications). ARIES provides assistance to requirements analysts for developing operational specifications of systems. This development begins with the acquisition of informal system requirements. The requirements are then formalized and gradually elaborated (transformed) into formal and complete specifications. ARIES provides guidance to the user in validating formal requirements by translating them into natural language representations and graphical diagrams. ARIES also provides ways of analyzing the specification to ensure that it is correct, e.g., testing the specification against a running simulation of the system to be built. Another important ARIES feature, especially when developing large systems, is the sharing and reuse of requirements knowledge. This leads to much less duplication of effort. ARIES combines all of its features in a single environment that makes the process of capturing a formal specification quicker and easier.

Unified quantitative characterization of epithelial tissue development

PubMed Central

Guirao, Boris; Rigaud, Stéphane U; Bosveld, Floris; Bailles, Anaïs; López-Gay, Jesús; Ishihara, Shuji; Sugimura, Kaoru

2015-01-01

Understanding the mechanisms regulating development requires a quantitative characterization of cell divisions, rearrangements, cell size and shape changes, and apoptoses. We developed a multiscale formalism that relates the characterizations of each cell process to tissue growth and morphogenesis. Having validated the formalism on computer simulations, we quantified separately all morphogenetic events in the Drosophila dorsal thorax and wing pupal epithelia to obtain comprehensive statistical maps linking cell and tissue scale dynamics. While globally cell shape changes, rearrangements and divisions all significantly participate in tissue morphogenesis, locally, their relative participations display major variations in space and time. By blocking division we analyzed the impact of division on rearrangements, cell shape changes and tissue morphogenesis. Finally, by combining the formalism with mechanical stress measurement, we evidenced unexpected interplays between patterns of tissue elongation, cell division and stress. Our formalism provides a novel and rigorous approach to uncover mechanisms governing tissue development. DOI: http://dx.doi.org/10.7554/eLife.08519.001 PMID:26653285

A Scoping Review of Peer-led Education in Patient Safety Training

PubMed Central

McLachlan, Andrew J.; Chen, Timothy F.

2018-01-01

Objective. To examine the literature pertaining to the use of peer-led education in patient safety. Findings. Four studies met the inclusion criteria: two were conducted in health care students and two in medical practitioners. Three studies used pre-post evaluation, with one containing a comparator group. One study a post-intervention evaluation only. All studies undertook Kirkpatrick Level 2 evaluations, showing significant improvements in attitudes and knowledge. One study undertook Level 3 and 4 evaluations, showing improvement in self-reported behaviors and engagement in quality improvement initiatives. Summary. There are few studies evaluating peer-led education in patient safety and formal and high-quality evaluations are lacking. PMID:29606704

Skin sensitisation--moving forward with non-animal testing strategies for regulatory purposes in the EU.

PubMed

Basketter, David; Alépée, Nathalie; Casati, Silvia; Crozier, Jonathan; Eigler, Dorothea; Griem, Peter; Hubesch, Bruno; de Knecht, Joop; Landsiedel, Robert; Louekari, Kimmo; Manou, Irene; Maxwell, Gavin; Mehling, Annette; Netzeva, Tatiana; Petry, Thomas; Rossi, Laura H

2013-12-01

In a previous EPAA-Cefic LRI workshop in 2011, issues surrounding the use and interpretation of results from the local lymph node assay were addressed. At the beginning of 2013 a second joint workshop focused greater attention on the opportunities to make use of non-animal test data, not least since a number of in vitro assays have progressed to an advanced position in terms of their formal validation. It is already recognised that information produced from non-animal assays can be used in regulatory decision-making, notably in terms of classifying a substance as a skin sensitiser. The evolution into a full replacement for hazard identification, where the decision is not to classify, requires the generation of confidence in the in vitro alternative, e.g. via formal validation, the existence of peer reviewed publications and the knowledge that the assay(s) are founded on key elements of the Adverse Outcome Pathway for skin sensitisation. It is foreseen that the validated in vitro assays and relevant QSAR models can be organised into formal testing strategies to be applied for regulatory purposes by the industry. To facilitate progress, the European Partnership for Alternative Approaches to animal testing (EPAA) provided the platform for cross-industry and regulatory dialogue, enabling an essential and open debate on the acceptability of an in vitro based integrated strategy. Based on these considerations, a follow up activity was agreed upon to explore an example of an Integrated Testing Strategy for skin sensitisation hazard identification purposes in the context of REACH submissions. Copyright © 2013 Elsevier Inc. All rights reserved.

Pharmaceutical trials in general practice: the first 100 protocols. An audit by the clinical research ethics committee of the Royal College of General Practitioners.

PubMed Central

Wise, P.; Drury, M.

1996-01-01

OBJECTIVE: To assess the outcome of 100 general practice based, multicentre research projects submitted to the ethics committee of the Royal College of General Practitioners by pharmaceutical companies or their agents between 1984 and 1989. DESIGN: Analysis of consecutive submitted protocols for stated objectives, study design, and outcomes; detailed review of committee minutes and correspondence in relation to amendment and approval; assessment of final reports submitted at conclusion of studies. SUBJECTS: 82 finally approved protocols, embracing 34,523 proposed trial subjects and 1195 proposed general practice investigators. MAIN OUTCOME MEASURES: Success at enrolling subjects and investigators; commencement and completion data; validity of final report's assessment of efficacy, safety, tolerability, and acceptability; and method of use and dissemination of findings. RESULTS: 18 studies were not approved and 45 had to be amended. Randomised controlled trials comprised 46 of the original submissions. Remuneration considerations, inadequate information or consent sheets, pregnancy safety, the need to discontinue existing therapy, and suboptimal scientific content were major reasons for rejecting studies or asking for amendments. Of the 82 approved studies 8 were not started. Shortfalls of investigators (of 39%) and trial subjects (of 37%) and an overall 23% withdrawal rate were responsible for a significant incidence of inconclusive results. Within the six year follow up interval, only 19 of the studies had been formally published. CONCLUSIONS: This audit identified substantial ethical concerns in the process of approving multicentre general practice pharmaceutical research. PMID:8939118

Integrating unmet needs into dementia health-related quality of life research and care: Introduction of the Hierarchy Model of Needs in Dementia.

PubMed

Scholzel-Dorenbos, Carla J M; Meeuwsen, Els J; Olde Rikkert, Marcel G M

2010-01-01

To make an inventory of needs assessment instruments in dementia, to explore the interaction between unmet needs and health-related quality of life (HRQoL) and to relate these to the conceptual model of Maslow's Hierarchy of needs in order to design a dementia-specific model. Narrative review of literature on (measures of) needs of patients and caregivers and HRQoL determinants important in dementia. Relating these needs to individual goal setting instruments and Maslow's Hierarchy of needs model. The Camberwell Assessment of Needs for the Elderly (CANE) turns out to be a valid tool to assess needs of dementia patients, suitable for research and clinical use. The Carers' Needs Assessment for Dementia (CNA-D) is a valid instrument to assess needs of caregivers. Patients identified significantly fewer needs than (in)formal caregivers. The most important needs, that also determine large part of HRQoL, are need for information; support with regard to symptoms of dementia; social contact and company; and for health monitoring and safety. Goal attainment scaling in dementia is an important but not yet valid outcome measure, with only few data on feasibility in dementia patients. There are several instruments to assess needs of dementia patients and caregivers. Domains of unmet needs and HRQoL overlap. The Hierarchy Model of Needs in Dementia (HMND) offers a new theoretical framework to address the interplay between meeting of needs and improvement of HRQoL in dementia. By identifying unmet needs in dementia-research and focussing on unmet needs in dementia-care, much can be done to improve HRQoL.

Establishing Quantitative Software Metrics in Department of the Navy Programs

DTIC Science & Technology

2016-04-01

13 Quality to Metrics Dependency Matrix...11 7. Quality characteristics to metrics dependecy matrix...In accomplishing this goal, a need exists for a formalized set of software quality metrics . This document establishes the validity of those necessary

77 FR 45558 - 4.9 GHz Band

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-01

...The Commission allocated the 4940-4990 MHz (4.9 GHz) band in 2002 for fixed and mobile use and dedicated the band for public safety broadband communications. In the ten years since, the band has gone underutilized. The purpose of these proposed rules is to invigorate and maximize use of the 4.9 GHz band and attract more users while improving spectrum efficiency. The Commission seeks comment on formal coordination requirements, expanded eligibility, how the band can complement the 700 MHz public safety broadband network, technical rule changes, aeronautical mobile operations, interoperability standards, and deployment reporting.

Formal Verification Toolkit for Requirements and Early Design Stages

NASA Technical Reports Server (NTRS)

Badger, Julia M.; Miller, Sheena Judson

2011-01-01

Efficient flight software development from natural language requirements needs an effective way to test designs earlier in the software design cycle. A method to automatically derive logical safety constraints and the design state space from natural language requirements is described. The constraints can then be checked using a logical consistency checker and also be used in a symbolic model checker to verify the early design of the system. This method was used to verify a hybrid control design for the suit ports on NASA Johnson Space Center's Space Exploration Vehicle against safety requirements.

Model-based engineering for medical-device software.

PubMed

Ray, Arnab; Jetley, Raoul; Jones, Paul L; Zhang, Yi

2010-01-01

This paper demonstrates the benefits of adopting model-based design techniques for engineering medical device software. By using a patient-controlled analgesic (PCA) infusion pump as a candidate medical device, the authors show how using models to capture design information allows for i) fast and efficient construction of executable device prototypes ii) creation of a standard, reusable baseline software architecture for a particular device family, iii) formal verification of the design against safety requirements, and iv) creation of a safety framework that reduces verification costs for future versions of the device software. 1.

[Topical issues of biological safety under current conditions. Part 2. Conceptual, terminological, and definitive framework of biological safety].

PubMed

Onishchenko, G G; Smolenskiĭ, V Iu; Ezhlova, E B; Demina, Iu V; Toporkov, V P; Toporkov, A V; Liapin, M N; Kutyrev, V V

2013-01-01

In accordance with the established conceptual base for the up-to-date broad interpretation of biological safety, and IHR (2005), developed is the notional, terminological, and definitive framework, comprising 33 elements. Key item of the nomenclature is the biological safety that is identified as population safety (individual, social, national) from direct and (or) human environment mediated (occupational, socio-economic, geopolitical infrastructures, ecological system) exposures to hazardous biological factors. Ultimate objective of the biological safety provision is to prevent and liquidate aftermaths of emergency situations of biological character either of natural or human origin (anthropogenic) arising from direct and indirect impact of the biological threats to the public health compatible with national and international security hazard. Elaborated terminological framework allows for the construction of self-sufficient semantic content for biological safety provision, subject to formalization in legislative, normative and methodological respects and indicative of improvement as regards organizational and structural-functional groundwork of the Russian Federation National chemical and biological safety system, which is to become topical issue of Part 3.

On Nomological Validity and Auxiliary Assumptions: The Importance of Simultaneously Testing Effects in Social Cognitive Theories Applied to Health Behavior and Some Guidelines

PubMed Central

Hagger, Martin S.; Gucciardi, Daniel F.; Chatzisarantis, Nikos L. D.

2017-01-01

Tests of social cognitive theories provide informative data on the factors that relate to health behavior, and the processes and mechanisms involved. In the present article, we contend that tests of social cognitive theories should adhere to the principles of nomological validity, defined as the degree to which predictions in a formal theoretical network are confirmed. We highlight the importance of nomological validity tests to ensure theory predictions can be disconfirmed through observation. We argue that researchers should be explicit on the conditions that lead to theory disconfirmation, and identify any auxiliary assumptions on which theory effects may be conditional. We contend that few researchers formally test the nomological validity of theories, or outline conditions that lead to model rejection and the auxiliary assumptions that may explain findings that run counter to hypotheses, raising potential for ‘falsification evasion.’ We present a brief analysis of studies (k = 122) testing four key social cognitive theories in health behavior to illustrate deficiencies in reporting theory tests and evaluations of nomological validity. Our analysis revealed that few articles report explicit statements suggesting that their findings support or reject the hypotheses of the theories tested, even when findings point to rejection. We illustrate the importance of explicit a priori specification of fundamental theory hypotheses and associated auxiliary assumptions, and identification of the conditions which would lead to rejection of theory predictions. We also demonstrate the value of confirmatory analytic techniques, meta-analytic structural equation modeling, and Bayesian analyses in providing robust converging evidence for nomological validity. We provide a set of guidelines for researchers on how to adopt and apply the nomological validity approach to testing health behavior models. PMID:29163307

Efficiency improvement in proton dose calculations with an equivalent restricted stopping power formalism

NASA Astrophysics Data System (ADS)

Maneval, Daniel; Bouchard, Hugo; Ozell, Benoît; Després, Philippe

2018-01-01

The equivalent restricted stopping power formalism is introduced for proton mean energy loss calculations under the continuous slowing down approximation. The objective is the acceleration of Monte Carlo dose calculations by allowing larger steps while preserving accuracy. The fractional energy loss per step length ɛ was obtained with a secant method and a Gauss-Kronrod quadrature estimation of the integral equation relating the mean energy loss to the step length. The midpoint rule of the Newton-Cotes formulae was then used to solve this equation, allowing the creation of a lookup table linking ɛ to the equivalent restricted stopping power L eq, used here as a key physical quantity. The mean energy loss for any step length was simply defined as the product of the step length with L eq. Proton inelastic collisions with electrons were added to GPUMCD, a GPU-based Monte Carlo dose calculation code. The proton continuous slowing-down was modelled with the L eq formalism. GPUMCD was compared to Geant4 in a validation study where ionization processes alone were activated and a voxelized geometry was used. The energy straggling was first switched off to validate the L eq formalism alone. Dose differences between Geant4 and GPUMCD were smaller than 0.31% for the L eq formalism. The mean error and the standard deviation were below 0.035% and 0.038% respectively. 99.4 to 100% of GPUMCD dose points were consistent with a 0.3% dose tolerance. GPUMCD 80% falloff positions (R80 ) matched Geant’s R80 within 1 μm. With the energy straggling, dose differences were below 2.7% in the Bragg peak falloff and smaller than 0.83% elsewhere. The R80 positions matched within 100 μm. The overall computation times to transport one million protons with GPUMCD were 31-173 ms. Under similar conditions, Geant4 computation times were 1.4-20 h. The L eq formalism led to an intrinsic efficiency gain factor ranging between 30-630, increasing with the prescribed accuracy of simulations. The L eq formalism allows larger steps leading to a O(constant) algorithmic time complexity. It significantly accelerates Monte Carlo proton transport while preserving accuracy. It therefore constitutes a promising variance reduction technique for computing proton dose distributions in a clinical context.

Establishing Qualitative Software Metrics in Department of the Navy Programs

DTIC Science & Technology

2015-10-29

dedicated to provide the highest quality software to its users. In doing, there is a need for a formalized set of Software Quality Metrics . The goal...of this paper is to establish the validity of those necessary Quality metrics . In our approach we collected the data of over a dozen programs...provide the necessary variable data for our formulas and tested the formulas for validity. Keywords: metrics ; software; quality I. PURPOSE Space

Validation of Battery Safety for Space Missions

NASA Technical Reports Server (NTRS)

Jeevarajan, Judith

2012-01-01

Presentation covers: (1) Safety Certification Process at NASA (2) Safety Testing for Lithium-ion Batteries (3) Limitations Observed with Li-ion Batteries in High Voltage and High Capacity Configurations.

Representation of research hypotheses

PubMed Central

2011-01-01

Background Hypotheses are now being automatically produced on an industrial scale by computers in biology, e.g. the annotation of a genome is essentially a large set of hypotheses generated by sequence similarity programs; and robot scientists enable the full automation of a scientific investigation, including generation and testing of research hypotheses. Results This paper proposes a logically defined way for recording automatically generated hypotheses in machine amenable way. The proposed formalism allows the description of complete hypotheses sets as specified input and output for scientific investigations. The formalism supports the decomposition of research hypotheses into more specialised hypotheses if that is required by an application. Hypotheses are represented in an operational way – it is possible to design an experiment to test them. The explicit formal description of research hypotheses promotes the explicit formal description of the results and conclusions of an investigation. The paper also proposes a framework for automated hypotheses generation. We demonstrate how the key components of the proposed framework are implemented in the Robot Scientist “Adam”. Conclusions A formal representation of automatically generated research hypotheses can help to improve the way humans produce, record, and validate research hypotheses. Availability http://www.aber.ac.uk/en/cs/research/cb/projects/robotscientist/results/ PMID:21624164

Assessing the safety culture of care homes: a multimethod evaluation of the adaptation, face validity and feasibility of the Manchester Patient Safety Framework.

PubMed

Marshall, Martin; Cruickshank, Lesley; Shand, Jenny; Perry, Sarah; Anderson, James; Wei, Li; Parker, Dianne; de Silva, Debra

2017-09-01

Understanding the cultural characteristics of healthcare organisations is widely recognised to be an important component of patient safety. A growing number of vulnerable older people are living in care homes but little attention has been paid to safety culture in this sector. In this study, we aimed to adapt the Manchester Patient Safety Framework (MaPSaF), a commonly used tool in the health sector, for use in care homes and then to test its face validity and preliminary feasibility as a tool for developing a better understanding of safety culture in the sector. As part of a wider improvement programme to reduce the prevalence of common safety incidents among residents in 90 care homes in England, we adapted MaPSaF and carried out a multimethod participatory evaluation of its face validity and feasibility for care home staff. Data were collected using participant observation, interviews, documentary analysis and a survey, and were analysed thematically. MaPSaF required considerable adaptation in terms of its length, language and content in order for it to be perceived to be acceptable and useful to care home staff. The changes made reflected differences between the health and care home sectors in terms of the local context and wider policy environment, and the expectations, capacity and capabilities of the staff. Based on this preliminary study, the adapted tool, renamed 'Culture is Key', appears to have reasonable face validity and, with adequate facilitation, it is usable by front-line staff and useful in raising their awareness about safety issues. 'Culture is Key' is a new tool which appears to have acceptable face validity and feasibility to be used by care home staff to deepen their understanding of the safety culture of their organisations and therefore has potential to contribute to improving care for vulnerable older people. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Is It Safe? Reliability and Validity of Structured versus Unstructured Child Safety Judgments

ERIC Educational Resources Information Center

Bartelink, Cora; de Kwaadsteniet, Leontien; ten Berge, Ingrid J.; Witteman, Cilia L. M.

2017-01-01

Background: The LIRIK, an instrument for the assessment of child safety and risk, is designed to improve assessments by guiding professionals through a structured evaluation of relevant signs, risk factors, and protective factors. Objective: We aimed to assess the interrater agreement and the predictive validity of professionals' judgments made…

[Development and validation of the Korean patient safety culture scale for nursing homes].

PubMed

Yoon, Sook Hee; Kim, Byungsoo; Kim, Se Young

2013-06-01

The purpose of this study was to develop a tool to evaluate patient safety culture in nursing homes and to test its validity and reliability. A preliminary tool was developed through interviews with focus group, content validity tests, and a pilot study. A nationwide survey was conducted from February to April, 2011, using self-report questionnaires. Participants were 982 employees in nursing homes. Data were analyzed using Cronbach's alpha, item analysis, factor analysis, and multitrait/multi-Item analysis. From the results of the analysis, 27 final items were selected from 49 items on the preliminary tool. Items with low correlation with total scale were excluded. The 4 factors sorted by factor analysis contributed 63.4% of the variance in the total scale. The factors were labeled as leadership, organizational system, working attitude, management practice. Cronbach's alpha for internal consistency was .95 and the range for the 4 factors was from .86 to .93. The results of this study indicate that the Korean Patient Safety Culture Scale has reliability and validity and is suitable for evaluation of patient safety culture in Korean nursing homes.

Reliability and validity of the Edinburgh Postnatal Depression Scale (EPDS) for detecting perinatal common mental disorders (PCMDs) among women in low-and lower-middle-income countries: a systematic review.

PubMed

Shrestha, Sumitra Devi; Pradhan, Rina; Tran, Thach D; Gualano, Rosa C; Fisher, Jane R W

2016-04-04

The Edinburgh Postnatal Depression Scale (EPDS), originally developed in Britain, is one of the most widely used screening instruments for assessing symptoms of the Perinatal Common Mental Disorders (PCMDs) of depression and anxiety. However, its potential to detect PCMDs in culturally diverse low- and lower-middle income countries (LALMICs) is unclear. This systematic review aimed to appraise formally validated local language versions of the EPDS from these resource-constrained settings. Following the PRISMA protocol, we searched MEDLINE-OVID, CINAHL-Plus and PUBMED to identify studies reporting translation, cultural adaptation and formal validation of the EPDS to detect PCMDs among women in LALMICs. The quality of the studies meeting inclusion criteria was assessed using standard criteria and a new process-based criteria; which was developed specifically for this study. We identified 1281 records among which 16 met inclusion criteria; three further papers were identified by hand-searching reference lists. The publications reported findings from 12 LALMICs in 14 native languages. Most of these local language versions of the EPDS (LLV-EPDS) had lower precision for identifying true cases of PCMDs among women in the general perinatal population compared to the original English version. Only one study met all criteria for culturally sensitive translation, the others had not established the comprehensibility of the local version amongst representative groups of women in pre-testing. Many studies tested the LLV-EPDS only amongst convenience samples recruited at single health facilities. Diagnostic interviews for confirmation of mental disorders could have been influenced by the mental health professionals' lack of blinding to the initial screening results. Additionally, even when diagnostic-interviews were carried out in the local language, questions might not have been understood as most studies followed standard diagnostic protocol which had not been culturally adapted. Most of the LLV-EPDS from non-English speaking low- and middle-income-countries did not meet all criteria for formal validation of a screening instrument. Psychometric properties of LLV-EPDS could be enhanced by adopting the new process-based criteria for translation, adaptation and validation.

Integrating reasoning and clinical archetypes using OWL ontologies and SWRL rules.

PubMed

Lezcano, Leonardo; Sicilia, Miguel-Angel; Rodríguez-Solano, Carlos

2011-04-01

Semantic interoperability is essential to facilitate the computerized support for alerts, workflow management and evidence-based healthcare across heterogeneous electronic health record (EHR) systems. Clinical archetypes, which are formal definitions of specific clinical concepts defined as specializations of a generic reference (information) model, provide a mechanism to express data structures in a shared and interoperable way. However, currently available archetype languages do not provide direct support for mapping to formal ontologies and then exploiting reasoning on clinical knowledge, which are key ingredients of full semantic interoperability, as stated in the SemanticHEALTH report [1]. This paper reports on an approach to translate definitions expressed in the openEHR Archetype Definition Language (ADL) to a formal representation expressed using the Ontology Web Language (OWL). The formal representations are then integrated with rules expressed with Semantic Web Rule Language (SWRL) expressions, providing an approach to apply the SWRL rules to concrete instances of clinical data. Sharing the knowledge expressed in the form of rules is consistent with the philosophy of open sharing, encouraged by archetypes. Our approach also allows the reuse of formal knowledge, expressed through ontologies, and extends reuse to propositions of declarative knowledge, such as those encoded in clinical guidelines. This paper describes the ADL-to-OWL translation approach, describes the techniques to map archetypes to formal ontologies, and demonstrates how rules can be applied to the resulting representation. We provide examples taken from a patient safety alerting system to illustrate our approach. Copyright © 2010 Elsevier Inc. All rights reserved.

Injuries to emergency medicine residents on EMS rotations.

PubMed

Cone, D C; McNamara, R M

1998-01-01

To study the incidence and nature of injuries sustained by emergency medicine (EM) residents during EMS rotations, and steps taken at EM residency programs to increase resident safety during field activities. An eight-question survey form was mailed to all 114 U.S. EM residency directors, with a second mailing to nonresponders eight weeks after the initial mailing. A total of 105 surveys were returned (92%). Six surveys were from new programs whose residents have not yet rotated on EMS. These were excluded from further analysis, leaving 99 programs. Of these, 91 (92%) reported no injuries. One EM resident died in a helicopter crash in 1985. Seven other injury events were reported: 1) facial lacerations, rib fractures, and a shoulder injury in an ambulance accident; 2) an open finger fracture (crushed by a backboard); 3) contusions and a concussion when an ambulance was struck by a fire engine; 4) a groin pull sustained while entering a helicopter; 5) bilateral metatarsal fractures in a fall; 6) rib fractures, a pneumothorax, and a concussion in an ambulance accident; and 7) "minor injuries" sustained in a crash while responding to a scene in a program-owned response vehicle. Actions taken at residency programs to reduce the risk of injury include the use of ballistic vests (four programs), requiring helmets on flights (five programs), and changing flight experience from mandatory to optional (two programs). Ten programs (10%) reported using ground scene safety lectures, and nine programs (15% of those offering flights) reported various types of flight safety instruction. Sixty-nine programs (70%) reported no formal field safety training or other active steps to increase resident safety on EMS rotations. Injuries sustained by EM residents during EMS rotations are uncommon but nontrivial, with several serious injuries and one fatality reported. The majority of EM residency programs have no formal safety training programs for EMS rotations.

TOWARD A MODERN THEORY OF CASE.

ERIC Educational Resources Information Center

FILLMORE, CHARLES J.

THE PAPER QUESTIONS THE ADEQUACY OF CHOMSKY'S PROPOSALS FOR FORMALLY RECONSTRUCTING THE DISTINCTION BETWEEN GRAMMATICAL CATEGORIES AND GRAMMATICAL FUNCTIONS. THE DEEP STRUCTURE VALIDITY OF THE NOTIONS "SUBJECT" AND "OBJECT" IS ALSO QUESTIONED. THE WRITER PROPOSES TO RECOGNIZE, INSTEAD, VARIOUS INTRODUCED NOUN PHRASES SUGGESTIVE…

Ensuring the validity of calculated subcritical limits

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

Clark, H.K.

1977-01-01

The care taken at the Savannah River Laboratory and Plant to ensure the validity of calculated subcritical limits is described. Close attention is given to ANSI N16.1-1975, ''Validation of Calculational Methods for Nuclear Criticality Safety.'' The computer codes used for criticality safety computations, which are listed and are briefly described, have been placed in the SRL JOSHUA system to facilitate calculation and to reduce input errors. A driver module, KOKO, simplifies and standardizes input and links the codes together in various ways. For any criticality safety evaluation, correlations of the calculational methods are made with experiment to establish bias. Occasionallymore » subcritical experiments are performed expressly to provide benchmarks. Calculated subcritical limits contain an adequate but not excessive margin to allow for uncertainty in the bias. The final step in any criticality safety evaluation is the writing of a report describing the calculations and justifying the margin.« less

Towards a full integration of optimization and validation phases: An analytical-quality-by-design approach.

PubMed

Hubert, C; Houari, S; Rozet, E; Lebrun, P; Hubert, Ph

2015-05-22

When using an analytical method, defining an analytical target profile (ATP) focused on quantitative performance represents a key input, and this will drive the method development process. In this context, two case studies were selected in order to demonstrate the potential of a quality-by-design (QbD) strategy when applied to two specific phases of the method lifecycle: the pre-validation study and the validation step. The first case study focused on the improvement of a liquid chromatography (LC) coupled to mass spectrometry (MS) stability-indicating method by the means of the QbD concept. The design of experiments (DoE) conducted during the optimization step (i.e. determination of the qualitative design space (DS)) was performed a posteriori. Additional experiments were performed in order to simultaneously conduct the pre-validation study to assist in defining the DoE to be conducted during the formal validation step. This predicted protocol was compared to the one used during the formal validation. A second case study based on the LC/MS-MS determination of glucosamine and galactosamine in human plasma was considered in order to illustrate an innovative strategy allowing the QbD methodology to be incorporated during the validation phase. An operational space, defined by the qualitative DS, was considered during the validation process rather than a specific set of working conditions as conventionally performed. Results of all the validation parameters conventionally studied were compared to those obtained with this innovative approach for glucosamine and galactosamine. Using this strategy, qualitative and quantitative information were obtained. Consequently, an analyst using this approach would be able to select with great confidence several working conditions within the operational space rather than a given condition for the routine use of the method. This innovative strategy combines both a learning process and a thorough assessment of the risk involved. Copyright © 2015 Elsevier B.V. All rights reserved.

DOE interpretations Guide to OSH standards. Update to the Guide

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

Not Available

1994-03-31

Reflecting Secretary O`Leary`s focus on occupational safety and health, the Office of Occupational Safety is pleased to provide you with the latest update to the DOE Interpretations Guide to OSH Standards. This Guide was developed in cooperation with the Occupational Safety and Health Administration, which continued its support during this last revision by facilitating access to the interpretations found on the OSHA Computerized Information System (OCIS). This March 31, 1994 update contains 123 formal interpretation letters written OSHA. As a result of the unique requests received by the 1-800 Response Line, this update also contains 38 interpretations developed by DOE.more » This new occupational safety and health information adds still more important guidance to the four volume reference set that you presently have in your possession.« less

Work organization research at the National Institute for Occupational Safety and Health.

PubMed

Rosenstock, L

1997-01-01

For 25 years, the National Institute for Occupational Safety and Health (NIOSH) has conducted and sponsored laboratory, field, and epidemiological studies that have helped define the role of work organization factors in occupational safety and health. Research has focused on the health effects of specific job conditions, occupational stressors in specific occupations, occupational difference in the incidence of stressors and stress-related disorders, and intervention strategies. NIOSH and the American Psychological Association have formalized the concept of occupational health psychology and developed a postdoctoral training program. The National Occupational Research Agenda recognizes organization of work as one of 21 national occupational safety and health research priority areas. Future research should focus on industries, occupations, and populations at special risk; the impact of work organization on overall health; the identification of healthy organization characteristics; and the development of intervention strategies.

DOE interpretations Guide to OSH standards. Update to the Guide

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

Not Available

1994-03-31

Reflecting Secretary O`Leary`s focus on occupational safety and health, the Office of Occupational Safety is pleased to provide you with the latest update to the DOE Interpretations Guide to OSH Standards. This Guide was developed in cooperation with the Occupational Safety and Health Administration, which continued it`s support during this last revision by facilitating access to the interpretations found on the OSHA Computerized Information System (OCIS). This March 31, 1994 update contains 123 formal in letter written by OSHA. As a result of the unique requests received by the 1-800 Response Line, this update also contains 38 interpretations developed bymore » DOE. This new occupational safety and health information adds still more important guidance to the four volume reference set that you presently have in your possession.« less

Visualizing variations in organizational safety culture across an inter-hospital multifaceted workforce.

PubMed

Kobuse, Hiroe; Morishima, Toshitaka; Tanaka, Masayuki; Murakami, Genki; Hirose, Masahiro; Imanaka, Yuichi

2014-06-01

To develop a reliable and valid questionnaire that can distinguish features of organizational culture for patient safety across subgroups such as hospitals, professions, management/non-management positions and units/wards. We developed a Hospital Organizational Culture Questionnaire based on a conceptual framework incorporating items from a review of existing literature. The questionnaire was administered to hospital staff including doctors, nurses, allied health personnel, and administrative staff at six public hospitals in Japan. Reliability and validity were assessed through exploratory factor analysis, multitrait scaling analysis, Cronbach's alpha coefficient and multiple regression analysis using staff-perceived achievement of safety as the response variable. Discriminative power across subgroups was assessed with radar chart profiling. Of the 3304 hospital staff surveyed, 2924 (88.5%) responded. After exploratory factor analysis and multitrait analysis, the finalized questionnaire was composed of 24 items in the following eight dimensions: improvement orientation, passion for mission, professional growth, resource allocation prioritization, inter-sectional collaboration, responsibility and authority, teamwork, and information sharing. Construct validity and internal consistency of dimensions were confirmed with multitrait analysis and Cronbach's alpha coefficients, respectively. Multiple regression analysis showed that improvement orientation, passion for mission, resource allocation prioritization and information sharing were significantly associated with higher achievement in safety practices. Our questionnaire tool was able to distinguish features of safety culture among different subgroups. Our questionnaire demonstrated excellent validity and reliability, and revealed distinct cultural patterns among different subgroups. Quantitative assessment of organizational safety culture with this tool may further the understanding of associated characteristics of each subgroup and provide insight into organizational readiness for patient safety improvement. © 2014 John Wiley & Sons, Ltd.

Development and Validation of a Practical Instrument for Injury Prevention: The Occupational Safety and Health Monitoring and Assessment Tool (OSH-MAT).

PubMed

Sun, Yi; Arning, Martin; Bochmann, Frank; Börger, Jutta; Heitmann, Thomas

2018-06-01

The Occupational Safety and Health Monitoring and Assessment Tool (OSH-MAT) is a practical instrument that is currently used in the German woodworking and metalworking industries to monitor safety conditions at workplaces. The 12-item scoring system has three subscales rating technical, organizational, and personnel-related conditions in a company. Each item has a rating value ranging from 1 to 9, with higher values indicating higher standard of safety conditions. The reliability of this instrument was evaluated in a cross-sectional survey among 128 companies and its validity among 30,514 companies. The inter-rater reliability of the instrument was examined independently and simultaneously by two well-trained safety engineers. Agreement between the double ratings was quantified by the intraclass correlation coefficient and absolute agreement of the rating values. The content validity of the OSH-MAT was evaluated by quantifying the association between OSH-MAT values and 5-year average injury rates by Poisson regression analysis adjusted for the size of the companies and industrial sectors. The construct validity of OSH-MAT was examined by principle component factor analysis. Our analysis indicated good to very good inter-rater reliability (intraclass correlation coefficient = 0.64-0.74) of OSH-MAT values with an absolute agreement of between 72% and 81%. Factor analysis identified three component subscales that met exactly the structure theory of this instrument. The Poisson regression analysis demonstrated a statistically significant exposure-response relationship between OSH-MAT values and the 5-year average injury rates. These analyses indicate that OSH-MAT is a valid and reliable instrument that can be used effectively to monitor safety conditions at workplaces.

Towards a New Architecture for Autonomous Data Collection

NASA Astrophysics Data System (ADS)

Tanzi, T. J.; Roudier, Y.; Apvrille, L.

2015-08-01

A new generation of UAVs is coming that will help improve the situational awareness and assessment necessary to ensure quality data collection, especially in difficult conditions like natural disasters. Operators should be relieved from time-consuming data collection tasks as much as possible and at the same time, UAVs should assist data collection operations through a more insightful and automated guidance thanks to advanced sensing capabilities. In order to achieve this vision, two challenges must be addressed though. The first one is to achieve a sufficient autonomy, both in terms of navigation and of interpretation of the data sensed. The second one relates to the reliability of the UAV with respect to accidental (safety) or even malicious (security) risks. This however requires the design and development of new embedded architectures for drones to be more autonomous, while mitigating the harm they may potentially cause. We claim that the increased complexity and flexibility of such platforms requires resorting to modelling, simulation, or formal verification techniques in order to validate such critical aspects of the platform. This paper first discusses the potential and challenges faced by autonomous UAVs for data acquisition. The design of a flexible and adaptable embedded UAV architecture is then addressed. Finally, the need for validating the properties of the platform is discussed. Our approach is sketched and illustrated with the example of a lightweight drone performing 3D reconstructions out of the combination of 2D image acquisition and a specific motion control.

Observational studies: a valuable source for data on the true value of RA therapies.

PubMed

van Vollenhoven, Ronald F; Severens, Johan L

2011-03-01

The validity of observational studies is sometimes questioned because of the limitations of non-randomly assigned controls, various biases such as channeling bias, confounding by indication, and other pitfalls. Yet, (post-marketing) observational data can provide important information regarding not only drug safety but also the effectiveness and appropriate use of agents in the real world, outside of clinical trials. Observational studies also provide data regarding the wider value of these agents in terms of, for example, reducing the need for surgical procedures, reducing absenteeism and increasing productivity. Importantly, data from some observational registry studies have subsequently been confirmed by clinical trials, supporting the overall validity of the registry-based approach. Observational studies also allow measures such as health assessment questionnaire scores, disease activity scores, and glucocorticoid use over time to be monitored for longer periods. Furthermore, observational data in real, less strictly selected patients without the constraints of formal study populations may produce findings not observed in clinical trials but that warrant further investigation in a controlled trial environment. For example, recent data from the Stockholm tumor necrosis factor follow-up registry in Sweden showed increases in the time people worked after initiation of biologics that, surprisingly, continued into the fourth and fifth years of treatment--a finding not observed with standardized outcomes. Observational studies are truly an underappreciated and valuable source of data on the real value of anti-rheumatic therapies, and these data are essential for making sound decisions regarding coverage and reimbursement.

Man-Machine Integration Design and Analysis System (MIDAS) v5: Augmentations, Motivations, and Directions for Aeronautics Applications

NASA Technical Reports Server (NTRS)

Gore, Brian F.

2011-01-01

As automation and advanced technologies are introduced into transport systems ranging from the Next Generation Air Transportation System termed NextGen, to the advanced surface transportation systems as exemplified by the Intelligent Transportations Systems, to future systems designed for space exploration, there is an increased need to validly predict how the future systems will be vulnerable to error given the demands imposed by the assistive technologies. One formalized approach to study the impact of assistive technologies on the human operator in a safe and non-obtrusive manner is through the use of human performance models (HPMs). HPMs play an integral role when complex human-system designs are proposed, developed, and tested. One HPM tool termed the Man-machine Integration Design and Analysis System (MIDAS) is a NASA Ames Research Center HPM software tool that has been applied to predict human-system performance in various domains since 1986. MIDAS is a dynamic, integrated HPM and simulation environment that facilitates the design, visualization, and computational evaluation of complex man-machine system concepts in simulated operational environments. The paper will discuss a range of aviation specific applications including an approach used to model human error for NASA s Aviation Safety Program, and what-if analyses to evaluate flight deck technologies for NextGen operations. This chapter will culminate by raising two challenges for the field of predictive HPMs for complex human-system designs that evaluate assistive technologies: that of (1) model transparency and (2) model validation.

76 FR 30280 - Public Meeting To Discuss the Proposed Rule on Enhanced Weapons, Firearms Background Checks, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-25

... Proposed Rule on Enhanced Weapons, Firearms Background Checks, and Security Event Notifications AGENCY... the proposed enhanced weapons rule, the two draft regulatory guides, and the draft weapons safety.... No formal comments on the proposed enhanced weapons rule or the draft guidance documents will be...

Formalizing the First Day in an Organic Chemistry Laboratory Using a Studio-Based Approach

ERIC Educational Resources Information Center

Collison, Christina G.; Cody, Jeremy; Smith, Darren; Swartzenberg, Jennifer

2015-01-01

A novel studio-based lab module that incorporates student-centered activities was designed and implemented to introduce second-year undergraduate students to the first-semester organic chemistry laboratory. The "First Day" studio module incorporates learning objectives for the course, lab safety, and keeping a professional lab notebook.

Oncology biomarkers: discovery, validation, and clinical use.

PubMed

Heckman-Stoddard, Brandy M

2012-05-01

To discuss the discovery, validation, and clinical use of multiple types of biomarkers. Medical literature and published guidelines. Formal validation of biomarkers should include both retrospective analyses of well-characterized samples as well as a prospective clinical trial in which the biomarker is tested for its ability to predict the presence of disease or the efficacy of a cancer therapy. Biomarker development is complicated, with very few biomarker discoveries leading to clinically useful tests. Nurses should understand how a biomarker was developed, including the sensitivity and specificity before applying new biomarkers in the clinical setting. Copyright © 2012. Published by Elsevier Inc.

Face, Content, and Construct Validations of Endoscopic Needle Injection Simulator for Transurethral Bulking Agent in Treatment of Stress Urinary Incontinence.

PubMed

Farhan, Bilal; Soltani, Tandis; Do, Rebecca; Perez, Claudia; Choi, Hanul; Ghoniem, Gamal

2018-05-02

Endoscopic injection of urethral bulking agents is an office procedure that is used to treat stress urinary incontinence secondary to internal sphincteric deficiency. Validation studies important part of simulator evaluation and is considered important step to establish the effectiveness of simulation-based training. The endoscopic needle injection (ENI) simulator has not been formally validated, although it has been used widely at University of California, Irvine. We aimed to assess the face, content, and construct validity of the UC, Irvine ENI simulator. Dissected female porcine bladders were mounted in a modified Hysteroscopy Diagnostic Trainer. Using routine endoscopic equipment for this procedure with video monitoring, 6 urologists (experts group) and 6 urology trainee (novice group) completed urethral bulking agents injections on a total of 12 bladders using ENI simulator. Face and content validities were assessed by using structured quantitative survey which rating the realism. Construct validity was assessed by comparing the performance, time of the procedure, and the occlusive (anatomical and functional) evaluations between the experts and novices. Trainees also completed a postprocedure feedback survey. Effective injections were evaluated by measuring the retrograde urethral opening pressure, visual cystoscopic coaptation, and postprocedure gross anatomic examination. All 12 participants felt the simulator was a good training tool and should be used as essential part of urology training (face validity). ENI simulator showed good face and content validity with average score varies between the experts and the novices was 3.9/5 and 3.8/5, respectively. Content validity evaluation showed that most aspects of the simulator were adequately realistic (mean Likert scores 3.9-3.8/5). However, the bladder does not bleed, and sometimes thin. Experts significantly outperformed novices (p < 001) across all measure of performance therefore establishing construct validity. The ENI simulator shows face, content and construct validities, although few aspects of simulator were not very realistic (e.g., bleeding).This study provides a base for the future formal validation for this simulator and for continuing use of this simulator in endourology training. Copyright © 2018 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Nonlinear estimation of parameters in biphasic Arrhenius plots.

PubMed

Puterman, M L; Hrboticky, N; Innis, S M

1988-05-01

This paper presents a formal procedure for the statistical analysis of data on the thermotropic behavior of membrane-bound enzymes generated using the Arrhenius equation and compares the analysis to several alternatives. Data is modeled by a bent hyperbola. Nonlinear regression is used to obtain estimates and standard errors of the intersection of line segments, defined as the transition temperature, and slopes, defined as energies of activation of the enzyme reaction. The methodology allows formal tests of the adequacy of a biphasic model rather than either a single straight line or a curvilinear model. Examples on data concerning the thermotropic behavior of pig brain synaptosomal acetylcholinesterase are given. The data support the biphasic temperature dependence of this enzyme. The methodology represents a formal procedure for statistical validation of any biphasic data and allows for calculation of all line parameters with estimates of precision.

Maximising harm reduction in early specialty training for general practice: validation of a safety checklist

PubMed Central

2012-01-01

Background Making health care safer is a key policy priority worldwide. In specialty training, medical educators may unintentionally impact on patient safety e.g. through failures of supervision; providing limited feedback on performance; and letting poorly developed behaviours continue unchecked. Doctors-in-training are also known to be susceptible to medical error. Ensuring that all essential educational issues are addressed during training is problematic given the scale of the tasks to be undertaken. Human error and the reliability of local systems may increase the risk of safety-critical topics being inadequately covered. However adherence to a checklist reminder may improve the reliability of task delivery and maximise harm reduction. We aimed to prioritise the most safety-critical issues to be addressed in the first 12-weeks of specialty training in the general practice environment and validate a related checklist reminder. Methods We used mixed methods with different groups of GP educators (n = 127) and specialty trainees (n = 9) in two Scottish regions to prioritise, develop and validate checklist content. Generation and refinement of checklist themes and items were undertaken on an iterative basis using a range of methods including small group work in dedicated workshops; a modified-Delphi process; and telephone interviews. The relevance of potential checklist items was rated using a 4-point scale content validity index to inform final inclusion. Results 14 themes (e.g. prescribing safely; dealing with medical emergency; implications of poor record keeping; and effective & safe communication) and 47 related items (e.g. how to safety-net face-to-face or over the telephone; knowledge of practice systems for results handling; recognition of harm in children) were judged to be essential safety-critical educational issues to be covered. The mean content validity index ratio was 0.98. Conclusion A checklist was developed and validated for educational supervisors to assist in the reliable delivery of safety-critical educational issues in the opening 12-week period of training, and aligned with national curriculum competencies. The tool can also be adapted for use as a self-assessment instrument by trainees to guide patient safety-related learning needs. Dissemination and implementation of the checklist and self-rating scale are proceeding on a national, voluntary basis with plans to evaluate its feasibility and educational impact. PMID:22721273

Maximising harm reduction in early specialty training for general practice: validation of a safety checklist.

PubMed

Bowie, Paul; McKay, John; Kelly, Moya

2012-06-21

Making health care safer is a key policy priority worldwide. In specialty training, medical educators may unintentionally impact on patient safety e.g. through failures of supervision; providing limited feedback on performance; and letting poorly developed behaviours continue unchecked. Doctors-in-training are also known to be susceptible to medical error. Ensuring that all essential educational issues are addressed during training is problematic given the scale of the tasks to be undertaken. Human error and the reliability of local systems may increase the risk of safety-critical topics being inadequately covered. However adherence to a checklist reminder may improve the reliability of task delivery and maximise harm reduction. We aimed to prioritise the most safety-critical issues to be addressed in the first 12-weeks of specialty training in the general practice environment and validate a related checklist reminder. We used mixed methods with different groups of GP educators (n=127) and specialty trainees (n=9) in two Scottish regions to prioritise, develop and validate checklist content. Generation and refinement of checklist themes and items were undertaken on an iterative basis using a range of methods including small group work in dedicated workshops; a modified-Delphi process; and telephone interviews. The relevance of potential checklist items was rated using a 4-point scale content validity index to inform final inclusion. 14 themes (e.g. prescribing safely; dealing with medical emergency; implications of poor record keeping; and effective & safe communication) and 47 related items (e.g. how to safety-net face-to-face or over the telephone; knowledge of practice systems for results handling; recognition of harm in children) were judged to be essential safety-critical educational issues to be covered. The mean content validity index ratio was 0.98. A checklist was developed and validated for educational supervisors to assist in the reliable delivery of safety-critical educational issues in the opening 12-week period of training, and aligned with national curriculum competencies. The tool can also be adapted for use as a self-assessment instrument by trainees to guide patient safety-related learning needs. Dissemination and implementation of the checklist and self-rating scale are proceeding on a national, voluntary basis with plans to evaluate its feasibility and educational impact.

Needs Assessment for Electrosurgery Training of Residents and Faculty in Obstetrics and Gynecology

PubMed Central

Green, Isabel; Modest, Anna Merport; Milad, Magdy; Huang, Edwin; Ricciotti, Hope

2014-01-01

Background and Objectives: Effective application of electrosurgical techniques requires knowledge of energy sources and electric circuits to produce desired tissue effects. A lack of electrosurgery knowledge may negatively affect patient outcomes and safety. Our objective was to survey obstetrics-gynecology trainees and faculty to assess their basic knowledge of electrosurgery concepts as a needs assessment for formal electrosurgery training. Methods: We performed an observational study with a sample of convenience at 2 academic hospitals (Beth Israel Deaconess Medical Center and Mount Auburn Hospital). Grand rounds dedicated to electrosurgery teaching were conducted at each department of obstetrics and gynecology, where a short electrosurgery multiple-choice examination was administered to attendees. Results: The face validity of the test content was obtained from a gynecologic electrosurgery specialist. Forty-four individuals completed the examination. Test scores were analyzed by level of training to investigate whether scores positively correlated with more advanced career stages. The median test score was 45.5% among all participants (interquartile range, 36.4%–54.5%). Senior residents scored the highest (median score, 54.5%), followed by attendings (median score, 45.5%), junior residents and fellows (median score in both groups, 36.4%), and medical students (median score, 27.3%). Conclusion: Although surgeons have used electrosurgery for nearly a century, it remains poorly understood by most obstetrician-gynecologists. Senior residents, attendings, junior residents, and medical students all show a general deficiency in electrosurgery comprehension. This study suggests that there is a need for formal electrosurgery training. A standardized electrosurgery curriculum with a workshop component demonstrating clinically useful concepts essential for safe surgical practice is advised. PMID:25392632

Evaluation of the neighborhood environment walkability scale in Nigeria.

PubMed

Oyeyemi, Adewale L; Sallis, James F; Deforche, Benedicte; Oyeyemi, Adetoyeje Y; De Bourdeaudhuij, Ilse; Van Dyck, Delfien

2013-03-21

The development of reliable and culturally sensitive measures of attributes of the built and social environment is necessary for accurate analysis of environmental correlates of physical activity in low-income countries, that can inform international evidence-based policies and interventions in the worldwide prevention of physical inactivity epidemics. This study systematically adapted the Neighborhood Environment Walkability Scale (NEWS) for Nigeria and evaluated aspects of reliability and validity of the adapted version among Nigerian adults. The adaptation of the NEWS was conducted by African and international experts, and final items were selected for NEWS-Nigeria after a cross-validation of the confirmatory factor analysis structure of the original NEWS. Participants (N = 386; female = 47.2%) from two cities in Nigeria completed the adapted NEWS surveys regarding perceived residential density, land use mix - diversity, land use mix - access, street connectivity, infrastructure and safety for walking and cycling, aesthetics, traffic safety, and safety from crime. Self-reported activity for leisure, walking for different purposes, and overall physical activity were assessed with the validated International Physical Activity Questionnaire (long version). The adapted NEWS subscales had moderate to high test-retest reliability (ICC range 0.59 -0.91). Construct validity was good, with residents of high-walkable neighborhoods reporting significantly higher residential density, more land use mix diversity, higher street connectivity, more traffic safety and more safety from crime, but lower infrastructure and safety for walking/cycling and aesthetics than residents of low-walkable neighborhoods. Concurrent validity correlations were low to moderate (r = 0.10 -0.31) with residential density, land use mix diversity, and traffic safety significantly associated with most physical activity outcomes. The NEWS-Nigeria demonstrated acceptable measurement properties among Nigerian adults and may be useful for evaluation of the built environment in Nigeria. Further adaptation and evaluation in other African countries is needed to create a version that could be used throughout the African region.

Developing a primary care patient measure of safety (PC PMOS): a modified Delphi process and face validity testing.

PubMed

Hernan, Andrea L; Giles, Sally J; O'Hara, Jane K; Fuller, Jeffrey; Johnson, Julie K; Dunbar, James A

2016-04-01

Patients are a valuable source of information about ways to prevent harm in primary care and are in a unique position to provide feedback about the factors that contribute to safety incidents. Unlike in the hospital setting, there are currently no tools that allow the systematic capture of this information from patients. The aim of this study was to develop a quantitative primary care patient measure of safety (PC PMOS). A two-stage approach was undertaken to develop questionnaire domains and items. Stage 1 involved a modified Delphi process. An expert panel reached consensus on domains and items based on three sources of information (validated hospital PMOS, previous research conducted by our study team and literature on threats to patient safety). Stage 2 involved testing the face validity of the questionnaire developed during stage 1 with patients and primary care staff using the 'think aloud' method. Following this process, the questionnaire was revised accordingly. The PC PMOS was received positively by both patients and staff during face validity testing. Barriers to completion included the length, relevance and clarity of questions. The final PC PMOS consisted of 50 items across 15 domains. The contributory factors to safety incidents centred on communication, access to care, patient-related factors, organisation and care planning, task performance and information flow. This is the first tool specifically designed for primary care settings, which allows patients to provide feedback about factors contributing to potential safety incidents. The PC PMOS provides a way for primary care organisations to learn about safety from the patient perspective and make service improvements with the aim of reducing harm in this setting. Future research will explore the reliability and construct validity of the PC PMOS. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Gravitational radiation quadrupole formula is valid for gravitationally interacting systems

NASA Technical Reports Server (NTRS)

Walker, M.; Will, C. M.

1980-01-01

An argument is presented for the validity of the quadrupole formula for gravitational radiation energy loss in the far field of nearly Newtonian (e.g., binary stellar) systems. This argument differs from earlier ones in that it determines beforehand the formal accuracy of approximation required to describe gravitationally self-interacting systems, uses the corresponding approximate equation of motion explicitly, and evaluates the appropriate asymptotic quantities by matching along the correct space-time light cones.

Circuitbot

DTIC Science & Technology

2016-03-01

constraints problem. Game rules described valid moves allowing player to generate a memory graph performing improved C program verification . 15. SUBJECT...TERMS Formal Verification , Static Analysis, Abstract Interpretation, Pointer Analysis, Fixpoint Iteration 16. SECURITY CLASSIFICATION OF: 17...36 3.4.12 Example: Game Play . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 3.4.13 Verification

Simulation for Prediction of Entry Article Demise (SPEAD): An Analysis Tool for Spacecraft Safety Analysis and Ascent/Reentry Risk Assessment

NASA Technical Reports Server (NTRS)

Ling, Lisa

2014-01-01

For the purpose of performing safety analysis and risk assessment for a potential off-nominal atmospheric reentry resulting in vehicle breakup, a synthesis of trajectory propagation coupled with thermal analysis and the evaluation of node failure is required to predict the sequence of events, the timeline, and the progressive demise of spacecraft components. To provide this capability, the Simulation for Prediction of Entry Article Demise (SPEAD) analysis tool was developed. The software and methodology have been validated against actual flights, telemetry data, and validated software, and safety/risk analyses were performed for various programs using SPEAD. This report discusses the capabilities, modeling, validation, and application of the SPEAD analysis tool.

Measuring safety climate in health care.

PubMed

Flin, R; Burns, C; Mearns, K; Yule, S; Robertson, E M

2006-04-01

To review quantitative studies of safety climate in health care to examine the psychometric properties of the questionnaires designed to measure this construct. A systematic literature review was undertaken to study sample and questionnaire design characteristics (source, no of items, scale type), construct validity (content validity, factor structure and internal reliability, concurrent validity), within group agreement, and level of analysis. Twelve studies were examined. There was a lack of explicit theoretical underpinning for most questionnaires and some instruments did not report standard psychometric criteria. Where this information was available, several questionnaires appeared to have limitations. More consideration should be given to psychometric factors in the design of healthcare safety climate instruments, especially as these are beginning to be used in large scale surveys across healthcare organisations.

Development and initial validation of an Aviation Safety Climate Scale.

PubMed

Evans, Bronwyn; Glendon, A Ian; Creed, Peter A

2007-01-01

A need was identified for a consistent set of safety climate factors to provide a basis for aviation industry benchmarking. Six broad safety climate themes were identified from the literature and consultations with industry safety experts. Items representing each of the themes were prepared and administered to 940 Australian commercial pilots. Data from half of the sample (N=468) were used in an exploratory factor analysis that produced a 3-factor model of Management commitment and communication, Safety training and equipment, and Maintenance. A confirmatory factor analysis on the remaining half of the sample showed the 3-factor model to be an adequate fit to the data. The results of this study have produced a scale of safety climate for aviation that is both reliable and valid. This study developed a tool to assess the level of perceived safety climate, specifically of pilots, but may also, with minor modifications, be used to assess other groups' perceptions of safety climate.

Traditional acupuncturists and higher education in Britain: the dual, paradoxical impact of biomedical alignment on the holistic view.

PubMed

Givati, Assaf; Hatton, Kieron

2015-04-01

Traditional acupuncturists' quest for external legitimacy in Britain involves the standardization of their knowledge bases through the development of training schools and syllabi, formal educational structures, and, since the 1990s, the teaching of undergraduate courses within (or validated by) Higher Education Institutions (HEIs), a process which entails biomedical alignment of the curriculum. However, as holistic discourses were commonly used as a rhetorical strategy by CAM practitioners to distance themselves from biomedicine and as a source of public appeal, this 'mainstreaming' process evoked practitioners' concerns that their holistic claims are being compromised. An additional challenge is being posed by a group of academics and scientists in Britain who launched an attack on CAM courses taught in HEIs, accusing them of being 'unscientific' and 'non-academic' in nature. This paper explores the negotiation of all these challenges during the formalization of traditional acupuncture education in Britain, with a particular focus on the role of HEIs. The in-depth qualitative investigation draws on several data sets: participant observation in a university validated acupuncture course; in-depth interviews; and documentary analysis. The findings show how, as part of the formalization process, acupuncturists in Britain (re)negotiate their holistic, anti-reductionist discourses and claims in relation to contemporary societal, political and cultural forces. Moreover, the teaching and validation of acupuncture courses by HEIs may contribute to broadening acupuncturists' 'holistic awareness' of societal and cultural influences on individuals' and communities' ill-health. This investigation emphasises the dynamic and context-specific (rather than fixed and essentialized) nature of acupuncture practice and knowledge. Copyright © 2015 Elsevier Ltd. All rights reserved.

Ensuring the safety of future PCIVs : paper 09-0316.

DOT National Transportation Integrated Search

2009-06-01

NHTSA, in partnership with Federal agencies, industry, and academia, will support research on safety-centered design and performance modeling and validation to enable and foster superior, integrated safety performance of future light-weight Plastics ...

Modeling and validating HL7 FHIR profiles using semantic web Shape Expressions (ShEx).

PubMed

Solbrig, Harold R; Prud'hommeaux, Eric; Grieve, Grahame; McKenzie, Lloyd; Mandel, Joshua C; Sharma, Deepak K; Jiang, Guoqian

2017-03-01

HL7 Fast Healthcare Interoperability Resources (FHIR) is an emerging open standard for the exchange of electronic healthcare information. FHIR resources are defined in a specialized modeling language. FHIR instances can currently be represented in either XML or JSON. The FHIR and Semantic Web communities are developing a third FHIR instance representation format in Resource Description Framework (RDF). Shape Expressions (ShEx), a formal RDF data constraint language, is a candidate for describing and validating the FHIR RDF representation. Create a FHIR to ShEx model transformation and assess its ability to describe and validate FHIR RDF data. We created the methods and tools that generate the ShEx schemas modeling the FHIR to RDF specification being developed by HL7 ITS/W3C RDF Task Force, and evaluated the applicability of ShEx in the description and validation of FHIR to RDF transformations. The ShEx models contributed significantly to workgroup consensus. Algorithmic transformations from the FHIR model to ShEx schemas and FHIR example data to RDF transformations were incorporated into the FHIR build process. ShEx schemas representing 109 FHIR resources were used to validate 511 FHIR RDF data examples from the Standards for Trial Use (STU 3) Ballot version. We were able to uncover unresolved issues in the FHIR to RDF specification and detect 10 types of errors and root causes in the actual implementation. The FHIR ShEx representations have been included in the official FHIR web pages for the STU 3 Ballot version since September 2016. ShEx can be used to define and validate the syntax of a FHIR resource, which is complementary to the use of RDF Schema (RDFS) and Web Ontology Language (OWL) for semantic validation. ShEx proved useful for describing a standard model of FHIR RDF data. The combination of a formal model and a succinct format enabled comprehensive review and automated validation. Copyright © 2017 Elsevier Inc. All rights reserved.

A Program Certification Assistant Based on Fully Automated Theorem Provers

NASA Technical Reports Server (NTRS)

Denney, Ewen; Fischer, Bernd

2005-01-01

We describe a certification assistant to support formal safety proofs for programs. It is based on a graphical user interface that hides the low-level details of first-order automated theorem provers while supporting limited interactivity: it allows users to customize and control the proof process on a high level, manages the auxiliary artifacts produced during this process, and provides traceability between the proof obligations and the relevant parts of the program. The certification assistant is part of a larger program synthesis system and is intended to support the deployment of automatically generated code in safety-critical applications.

[Definition of "Safety and Hygiene Packages" as a management model for the Hospital Hygiene Service (HHS)].

PubMed

Raponi, Matteo; Damiani, Gianfranco; Vincenti, Sara; Wachocka, Malgorzata; Boninti, Federica; Bruno, Stefania; Quaranta, Gianluigi; Moscato, Umberto; Boccia, Stefania; Ficarra, Maria Giovanna; Specchia, Maria Lucia; Posteraro, Brunella; Berloco, Filippo; Celani, Fabrizio; Ricciardi, Walter; Laurenti, Patrizia

2014-01-01

The purpose of this research is to identify and formalize the Hospital Hygiene Service activities and products, evaluating them in a cost accounting management view. The ultimate aim, is to evaluate the financial adverse events prevention impact, in an Hospital Hygiene Service management. A three step methodology based on affinity grouping activities, was employed. This methodology led us to identify 4 action areas, with 23 related productive processes, and 86 available safety packages. Owing to this new methodology, we was able to implement a systematic evaluation of the furnished services.

Validation & Safety Constraints: What We Want to Do… What We Can Do

NASA Astrophysics Data System (ADS)

Yepez, Amaya Atenicia; Peiro, Belen Martin; Bory, Stephane

2010-09-01

Autonomous safety critical systems require an exhaustive validation in order to guarantee robustness from different perspectives(SW, HW and algorithm design). In this paper we are presenting a performance validation approach dealing with an extensive list of difficulties, as lessons learnt from the space projects developed by GMV(e.g. within EGNOS and Galileo Programs). We will strongly recommend that the selected validation strategy is decided from the early stages of the system definition and it is carried out listening to the opinions and demands of all parties. In fact, to agree on the final solution, a trade-off will be needed in order to validate the requirements with the available means, in terms of amount of data and resources.

Effect of Formal Education on Vascular Cognitive Impairment after Stroke: A Meta-analysis and Study in Young-Stroke Patients.

PubMed

Kessels, Roy P C; Eikelboom, Willem Sake; Schaapsmeerders, Pauline; Maaijwee, Noortje A M; Arntz, Renate M; van Dijk, Ewoud J; de Leeuw, Frank-Erik

2017-03-01

The extent of vascular cognitive impairment (VCI) after stroke varies greatly across individuals, even when the same amount of brain damage is present. Education level is a potentially protective factor explaining these differences, but results on its effects on VCI are inconclusive. First, we performed a meta-analysis on formal education and VCI, identifying 21 studies (N=7770). Second, we examined the effect of formal education on VCI in young-stroke patients who were cognitively assessed on average 11.0 (SD=8.2) years post-stroke (the FUTURE study cohort). The total sample consisted of 277 young-stroke patients with a mean age at follow-up 50.9 (SD=10.3). Age and education-adjusted expected scores were computed using 146 matched stroke-free controls. The meta-analysis showed an overall effect size (z') of 0.25 (95% confidence interval [0.18-0.31]), indicating that formal education level had a small to medium effect on VCI. Analyses of the FUTURE data showed that the effect of education on post-stroke executive dysfunction was mediated by age (β age -0.015; p<.05). Below-average performance in the attention domain was more frequent for low-education patients (χ2(2)=9.8; p<.05). While education level was found to be related to post-stroke VCI in previous research, the effects were small. Further analysis in a large stroke cohort showed that these education effects were fully mediated by age, even in relatively young stroke patients. Education level in and of itself does not appear to be a valid indicator of cognitive reserve. Multi-indicator methods may be more valid, but have not been studied in relation to VCI. (JINS, 2017, 23, 223-238).

A bibliography on formal methods for system specification, design and validation

NASA Technical Reports Server (NTRS)

Meyer, J. F.; Furchtgott, D. G.; Movaghar, A.

1982-01-01

Literature on the specification, design, verification, testing, and evaluation of avionics systems was surveyed, providing 655 citations. Journal papers, conference papers, and technical reports are included. Manual and computer-based methods were employed. Keywords used in the online search are listed.

Coercion, incarceration, and chemical castration: an argument from autonomy.

PubMed

Douglas, Thomas; Bonte, Pieter; Focquaert, Farah; Devolder, Katrien; Sterckx, Sigrid

2013-10-01

In several jurisdictions, sex offenders may be offered chemical castration as an alternative to further incarceration. In some, agreement to chemical castration may be made a formal condition of parole or release. In others, refusal to undergo chemical castration can increase the likelihood of further incarceration though no formal link is made between the two. Offering chemical castration as an alternative to further incarceration is often said to be partially coercive, thus rendering the offender's consent invalid. The dominant response to this objection has been to argue that any coercion present in such cases is compatible with valid consent. In this article, we take a different tack, arguing that, even if consent would not be valid, offering chemical castration will often be supported by the very considerations that underpin concerns about consent: considerations of autonomy. This is because offering chemical castration will often increase the offender's autonomy, both at the time the offer is made and in the future.

Validity of a Sun Safety Diary Using UV Monitors in Middle School Children

ERIC Educational Resources Information Center

Yaroch, Amy L.; Reynolds, Kim D.; Buller, David B.; Maloy, Julie A.; Geno, Cristy R.

2006-01-01

This article describes a validity study conducted among middle school students comparing self-reported sun safety behaviors from a diary with readings from ultraviolet (UV) monitors worn on different body sites. The UV monitors are stickers with panels that turn increasingly darker shades of blue in the presence of increasing amounts of UV light.…

A Validation Study of the Revised Personal Safety Decision Scale

ERIC Educational Resources Information Center

Kim, HaeJung; Hopkins, Karen M.

2017-01-01

Objective: The purpose of this study is to examine the reliability and validity of an 11-item Personal Safety Decision Scale (PSDS) in a sample of child welfare workers. Methods: Data were derived from a larger cross-sectional online survey to a random stratified sample of 477 public child welfare workers in a mid-Atlantic State. An exploratory…

Team Psychological Safety and Team Learning: A Cultural Perspective

ERIC Educational Resources Information Center

Cauwelier, Peter; Ribière, Vincent M.; Bennet, Alex

2016-01-01

Purpose: The purpose of this paper was to evaluate if the concept of team psychological safety, a key driver of team learning and originally studied in the West, can be applied in teams from different national cultures. The model originally validated for teams in the West is applied to teams in Thailand to evaluate its validity, and the views team…

Seat Belts: 1949-1956

DOT National Transportation Integrated Search

1979-04-01

The study assesses the impact of the consumer misconceptions, the lack of a seat belt standard, corporate attitudes towards safety, and the role of safety advocates. In addition, the study assesses the validity of the oft-stated hypothesis "safety do...

Dependability modeling and assessment in UML-based software development.

PubMed

Bernardi, Simona; Merseguer, José; Petriu, Dorina C

2012-01-01

Assessment of software nonfunctional properties (NFP) is an important problem in software development. In the context of model-driven development, an emerging approach for the analysis of different NFPs consists of the following steps: (a) to extend the software models with annotations describing the NFP of interest; (b) to transform automatically the annotated software model to the formalism chosen for NFP analysis; (c) to analyze the formal model using existing solvers; (d) to assess the software based on the results and give feedback to designers. Such a modeling→analysis→assessment approach can be applied to any software modeling language, be it general purpose or domain specific. In this paper, we focus on UML-based development and on the dependability NFP, which encompasses reliability, availability, safety, integrity, and maintainability. The paper presents the profile used to extend UML with dependability information, the model transformation to generate a DSPN formal model, and the assessment of the system properties based on the DSPN results.

Dependability Modeling and Assessment in UML-Based Software Development

PubMed Central

Bernardi, Simona; Merseguer, José; Petriu, Dorina C.

2012-01-01

Assessment of software nonfunctional properties (NFP) is an important problem in software development. In the context of model-driven development, an emerging approach for the analysis of different NFPs consists of the following steps: (a) to extend the software models with annotations describing the NFP of interest; (b) to transform automatically the annotated software model to the formalism chosen for NFP analysis; (c) to analyze the formal model using existing solvers; (d) to assess the software based on the results and give feedback to designers. Such a modeling→analysis→assessment approach can be applied to any software modeling language, be it general purpose or domain specific. In this paper, we focus on UML-based development and on the dependability NFP, which encompasses reliability, availability, safety, integrity, and maintainability. The paper presents the profile used to extend UML with dependability information, the model transformation to generate a DSPN formal model, and the assessment of the system properties based on the DSPN results. PMID:22988428

An Approach for Validating Actinide and Fission Product Burnup Credit Criticality Safety Analyses: Criticality (k eff) Predictions

DOE PAGES

Scaglione, John M.; Mueller, Don E.; Wagner, John C.

2014-12-01

One of the most important remaining challenges associated with expanded implementation of burnup credit in the United States is the validation of depletion and criticality calculations used in the safety evaluation—in particular, the availability and use of applicable measured data to support validation, especially for fission products (FPs). Applicants and regulatory reviewers have been constrained by both a scarcity of data and a lack of clear technical basis or approach for use of the data. In this study, this paper describes a validation approach for commercial spent nuclear fuel (SNF) criticality safety (k eff) evaluations based on best-available data andmore » methods and applies the approach for representative SNF storage and transport configurations/conditions to demonstrate its usage and applicability, as well as to provide reference bias results. The criticality validation approach utilizes not only available laboratory critical experiment (LCE) data from the International Handbook of Evaluated Criticality Safety Benchmark Experiments and the French Haut Taux de Combustion program to support validation of the principal actinides but also calculated sensitivities, nuclear data uncertainties, and limited available FP LCE data to predict and verify individual biases for relevant minor actinides and FPs. The results demonstrate that (a) sufficient critical experiment data exist to adequately validate k eff calculations via conventional validation approaches for the primary actinides, (b) sensitivity-based critical experiment selection is more appropriate for generating accurate application model bias and uncertainty, and (c) calculated sensitivities and nuclear data uncertainties can be used for generating conservative estimates of bias for minor actinides and FPs. Results based on the SCALE 6.1 and the ENDF/B-VII.0 cross-section libraries indicate that a conservative estimate of the bias for the minor actinides and FPs is 1.5% of their worth within the application model. Finally, this paper provides a detailed description of the approach and its technical bases, describes the application of the approach for representative pressurized water reactor and boiling water reactor safety analysis models, and provides reference bias results based on the prerelease SCALE 6.1 code package and ENDF/B-VII nuclear cross-section data.« less

46 CFR 176.910 - Passenger Ship Safety Certificate.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 7 2011-10-01 2011-10-01 false Passenger Ship Safety Certificate. 176.910 Section 176..., as Amended (SOLAS) § 176.910 Passenger Ship Safety Certificate. (a) A vessel, which carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate...

46 CFR 115.910 - Passenger Ship Safety Certificate.

Code of Federal Regulations, 2011 CFR

2011-10-01

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

46 CFR 115.910 - Passenger Ship Safety Certificate.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 4 2010-10-01 2010-10-01 false Passenger Ship Safety Certificate. 115.910 Section 115... Ship Safety Certificate. (a) A vessel that carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate. The Commandant issues the original SOLAS...

46 CFR 115.910 - Passenger Ship Safety Certificate.

Code of Federal Regulations, 2014 CFR

2014-10-01

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

46 CFR 176.910 - Passenger Ship Safety Certificate.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 7 2012-10-01 2012-10-01 false Passenger Ship Safety Certificate. 176.910 Section 176..., as Amended (SOLAS) § 176.910 Passenger Ship Safety Certificate. (a) A vessel, which carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate...

46 CFR 115.910 - Passenger Ship Safety Certificate.

Code of Federal Regulations, 2012 CFR

2012-10-01

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

46 CFR 176.910 - Passenger Ship Safety Certificate.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 7 2013-10-01 2013-10-01 false Passenger Ship Safety Certificate. 176.910 Section 176..., as Amended (SOLAS) § 176.910 Passenger Ship Safety Certificate. (a) A vessel, which carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate...

46 CFR 115.910 - Passenger Ship Safety Certificate.

Code of Federal Regulations, 2013 CFR

2013-10-01

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

46 CFR 176.910 - Passenger Ship Safety Certificate.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 7 2014-10-01 2014-10-01 false Passenger Ship Safety Certificate. 176.910 Section 176..., as Amended (SOLAS) § 176.910 Passenger Ship Safety Certificate. (a) A vessel, which carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate...

Teaching and Assessment of Mathematical Principles for Software Correctness Using a Reasoning Concept Inventory

ERIC Educational Resources Information Center

Drachova-Strang, Svetlana V.

2013-01-01

As computing becomes ubiquitous, software correctness has a fundamental role in ensuring the safety and security of the systems we build. To design and develop software correctly according to their formal contracts, CS students, the future software practitioners, need to learn a critical set of skills that are necessary and sufficient for…

Can Competency-Based Training Fly?: An Overview of Key Issues for "Ab Initio" Pilot Training

ERIC Educational Resources Information Center

Franks, Peter; Hay, Stephen; Mavin, Tim

2014-01-01

Competency-based training (CBT) for pilots was formally introduced in 1999 by the Civil Aviation Safety Authority (CASA) for training leading to the issue of aeroplane private and commercial pilot licences. This initiative followed the Australian government's introduction of CBT policy for vocational and workplace training in the late 1980's.…

An Exploratory Study on the Post-Implementation of Threat and Error Management Training in Australian General Aviation

ERIC Educational Resources Information Center

Lee, Seung Yong; Bates, Paul R.; Murray, Patrick S.; Martin, Wayne L.

2017-01-01

Threat and Error Management (TEM) training, endorsed and recommended by the International Civil Aviation Organisation (ICAO), was mandated in Australia with the aim of improving aviation safety. However, to date, there has been very limited, if any, formal post-implementation review, assessment or evaluation to examine the "after-state"…

Non-reporting of work injuries and aspects of jobsite safety climate and behavioral-based safety elements among carpenters in Washington State.

PubMed

Lipscomb, Hester J; Schoenfisch, Ashley L; Cameron, Wilfrid

2015-04-01

Declining work injury rates may reflect safer work conditions as well as under-reporting. Union carpenters were invited to participate in a mailed, cross-sectional survey designed to capture information about injury reporting practices. Prevalence of non-reporting and fear of repercussions for reporting were compared across exposure to behavioral-based safety elements and three domains of the Nordic Safety Climate Questionnaire (NOSACQ-50). The majority (>75%) of the 1,155 participants felt they could report work-related injuries to their supervisor without fear of retribution, and most felt that the majority of injuries on their jobsites got reported. However, nearly half indicated it was best not to report minor injuries, and felt pressures to use their private insurance for work injury care. The prevalence of non-reporting and fear of reporting increased markedly with poorer measures of management safety justice (NOSACQ-50). Formal and informal policies and practices on jobsites likely influence injury reporting. © 2015 Wiley Periodicals, Inc.

Statistical, epidemiological, and risk-assessment approaches to evaluating safety of vaccines throughout the life cycle at the Food and Drug Administration.

PubMed

Ball, Robert; Horne, Dale; Izurieta, Hector; Sutherland, Andrea; Walderhaug, Mark; Hsu, Henry

2011-05-01

The public health community faces increasing demands for improving vaccine safety while simultaneously increasing the number of vaccines available to prevent infectious diseases. The passage of the US Food and Drug Administration (FDA) Amendment Act of 2007 formalized the concept of life-cycle management of the risks and benefits of vaccines, from early clinical development through many years of use in large numbers of people. Harnessing scientific and technologic advances is necessary to improve vaccine-safety evaluation. The Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research is working to improve the FDA's ability to monitor vaccine safety by improving statistical, epidemiologic, and risk-assessment methods, gaining access to new sources of data, and exploring the use of genomics data. In this article we describe the current approaches, new resources, and future directions that the FDA is taking to improve the evaluation of vaccine safety.

Domain of validity of the perturbative approach to femtosecond optical spectroscopy

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

Gelin, Maxim F.; Rao, B. Jayachander; Nest, Mathias

2013-12-14

We have performed numerical nonperturbative simulations of transient absorption pump-probe responses for a series of molecular model systems. The resulting signals as a function of the laser field strength and the pump-probe delay time are compared with those obtained in the perturbative response function formalism. The simulations and their theoretical analysis indicate that the perturbative description remains valid up to moderately strong laser pulses, corresponding to a rather substantial depopulation (population) of the initial (final) electronic states.

CrossTalk: The Journal of Defense Software Engineering. Volume 26, Number 6, November/December 2013

DTIC Science & Technology

2013-12-01

requirements during sprint planning. Automated scanning, which includes automated code-review tools, allows the expert to monitor the system... sprint . This enables the validator to leverage the test results for formal validation and verification, and perform a shortened “hybrid” style of IV&V...per SPRINT (1-4 weeks) 1 week 1 Month Up to four months Ø Deliverable product to user Ø Security posture assessed Ø Accredited to field/operate

Multilevel model of safety climate for furniture industries.

PubMed

Rodrigues, Matilde A; Arezes, Pedro M; Leão, Celina P

2015-01-01

Furniture companies can analyze their safety status using quantitative measures. However, the data needed are not always available and the number of accidents is under-reported. Safety climate scales may be an alternative. However, there are no validated Portuguese scales that account for the specific attributes of the furniture sector. The current study aims to develop and validate an instrument that uses a multilevel structure to measure the safety climate of the Portuguese furniture industry. The Safety Climate in Wood Industries (SCWI) model was developed and applied to the safety climate analysis using three different scales: organizational, group and individual. A multilevel exploratory factor analysis was performed to analyze the factorial structure. The studied companies' safety conditions were also analyzed. Different factorial structures were found between and within levels. In general, the results show the presence of a group-level safety climate. The scores of safety climates are directly and positively related to companies' safety conditions; the organizational scale is the one that best reflects the actual safety conditions. The SCWI instrument allows for the identification of different safety climates in groups that comprise the same furniture company and it seems to reflect those groups' safety conditions. The study also demonstrates the need for a multilevel analysis of the studied instrument.

Lost in the chaos: Flawed literature should not generate new disorders.

PubMed

Van Rooij, Antonius J; Kardefelt-Winther, Daniel

2017-06-01

The paper by Kuss, Griffiths, and Pontes (2016) titled "Chaos and confusion in DSM-5 diagnosis of Internet Gaming Disorder: Issues, concerns, and recommendations for clarity in the field" examines issues relating to the concept of Internet Gaming Disorder. We agree that there are serious issues and extend their arguments by suggesting that the field lacks basic theory, definitions, patient research, and properly validated and standardized assessment tools. As most studies derive data from survey research in functional populations, they exclude people with severe functional impairment and provide only limited information on the hypothesized disorder. Yet findings from such studies are widely used and often exaggerated, leading many to believe that we know more about the problem behavior than we do. We further argue that video game play is associated with several benefits and that formalizing this popular hobby as a psychiatric disorder is not without risks. It might undermine children's right to play or encourage repressive treatment programs, which ultimately threaten children's right to protection against violence. While Kuss et al. (2016) express support for the formal implementation of a disorder, we argue that before we have a proper evidence base, a sound theory, and validated assessment tools, it is irresponsible to support a formal category of disorder and doing so would solidify a confirmatory approach to research in this area.

Lost in the chaos: Flawed literature should not generate new disorders

PubMed Central

Van Rooij, Antonius J.; Kardefelt-Winther, Daniel

2017-01-01

The paper by Kuss, Griffiths, and Pontes (2016) titled “Chaos and confusion in DSM-5 diagnosis of Internet Gaming Disorder: Issues, concerns, and recommendations for clarity in the field” examines issues relating to the concept of Internet Gaming Disorder. We agree that there are serious issues and extend their arguments by suggesting that the field lacks basic theory, definitions, patient research, and properly validated and standardized assessment tools. As most studies derive data from survey research in functional populations, they exclude people with severe functional impairment and provide only limited information on the hypothesized disorder. Yet findings from such studies are widely used and often exaggerated, leading many to believe that we know more about the problem behavior than we do. We further argue that video game play is associated with several benefits and that formalizing this popular hobby as a psychiatric disorder is not without risks. It might undermine children’s right to play or encourage repressive treatment programs, which ultimately threaten children’s right to protection against violence. While Kuss et al. (2016) express support for the formal implementation of a disorder, we argue that before we have a proper evidence base, a sound theory, and validated assessment tools, it is irresponsible to support a formal category of disorder and doing so would solidify a confirmatory approach to research in this area. PMID:28301968

A Spherical Harmonic Analysis of the Ooty Wide Field Array (OWFA) Visibility Signal

NASA Astrophysics Data System (ADS)

Chatterjee, Suman; Bharadwaj, Somnath

2018-04-01

Considering redshifted 21-cm intensity mapping with the upcoming OWFA whose field of view subtends ˜57° in the N-S direction, we present a formalism which relates the measured visibilities to the spherical harmonic coefficients of the sky signal. We use this to calculate window functions which relate the two-visibility correlations i.e. the correlation between the visibilities measured at two baselines and two frequencies, to different multipoles of the multi-frequency angular power spectrum Cℓ(ν1, ν2). The formalism here is validated using simulations. We also present approximate closed form analytical expressions which can be used to calculate the window functions. Comparing the widely adopted flat sky approximation, we find that its predictions match those of our spherical harmonic formalism to within 16% across the entire OWFA baseline range. The match improves at large baselines where we have <5% deviations.

The development and initial validation of a sensitive bedside cognitive screening test.

PubMed

Faust, D; Fogel, B S

1989-01-01

Brief bedside cognitive examinations such as the Mini-Mental State Examination are designed to detect delirium and dementia but not more subtle or delineated cognitive deficits. Formal neuropsychological evaluation provides greater sensitivity and detects a wider range of cognitive deficits but is too lengthy for efficient use at the bedside or in epidemiological studies. The authors developed the High Sensitivity Cognitive Screen (HSCS), a 20-minute interview-based test, to identify patients who show disorder on formal neuropsychological evaluation. An initial study demonstrated satisfactory test-retest and interrater reliability. The HSCS was then administered to 60 psychiatric and neurological patients with suspected cognitive deficits but without gross impairment, who also completed formal neuropsychological testing. Results of both tests were independently classified as either normal, borderline, or abnormal. The HSCS correctly classified 93% of patients across the normal-abnormal dichotomy and showed promise for characterizing the extent and severity of cognitive dysfunction.

DRS: Derivational Reasoning System

NASA Technical Reports Server (NTRS)

Bose, Bhaskar

1995-01-01

The high reliability requirements for airborne systems requires fault-tolerant architectures to address failures in the presence of physical faults, and the elimination of design flaws during the specification and validation phase of the design cycle. Although much progress has been made in developing methods to address physical faults, design flaws remain a serious problem. Formal methods provides a mathematical basis for removing design flaws from digital systems. DRS (Derivational Reasoning System) is a formal design tool based on advanced research in mathematical modeling and formal synthesis. The system implements a basic design algebra for synthesizing digital circuit descriptions from high level functional specifications. DRS incorporates an executable specification language, a set of correctness preserving transformations, verification interface, and a logic synthesis interface, making it a powerful tool for realizing hardware from abstract specifications. DRS integrates recent advances in transformational reasoning, automated theorem proving and high-level CAD synthesis systems in order to provide enhanced reliability in designs with reduced time and cost.

Approach for validating actinide and fission product compositions for burnup credit criticality safety analyses

DOE PAGES

Radulescu, Georgeta; Gauld, Ian C.; Ilas, Germina; ...

2014-11-01

This paper describes a depletion code validation approach for criticality safety analysis using burnup credit for actinide and fission product nuclides in spent nuclear fuel (SNF) compositions. The technical basis for determining the uncertainties in the calculated nuclide concentrations is comparison of calculations to available measurements obtained from destructive radiochemical assay of SNF samples. Probability distributions developed for the uncertainties in the calculated nuclide concentrations were applied to the SNF compositions of a criticality safety analysis model by the use of a Monte Carlo uncertainty sampling method to determine bias and bias uncertainty in effective neutron multiplication factor. Application ofmore » the Monte Carlo uncertainty sampling approach is demonstrated for representative criticality safety analysis models of pressurized water reactor spent fuel pool storage racks and transportation packages using burnup-dependent nuclide concentrations calculated with SCALE 6.1 and the ENDF/B-VII nuclear data. Furthermore, the validation approach and results support a recent revision of the U.S. Nuclear Regulatory Commission Interim Staff Guidance 8.« less

The SCALE Verified, Archived Library of Inputs and Data - VALID

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

Marshall, William BJ J; Rearden, Bradley T

The Verified, Archived Library of Inputs and Data (VALID) at ORNL contains high quality, independently reviewed models and results that improve confidence in analysis. VALID is developed and maintained according to a procedure of the SCALE quality assurance (QA) plan. This paper reviews the origins of the procedure and its intended purpose, the philosophy of the procedure, some highlights of its implementation, and the future of the procedure and associated VALID library. The original focus of the procedure was the generation of high-quality models that could be archived at ORNL and applied to many studies. The review process associated withmore » model generation minimized the chances of errors in these archived models. Subsequently, the scope of the library and procedure was expanded to provide high quality, reviewed sensitivity data files for deployment through the International Handbook of Evaluated Criticality Safety Benchmark Experiments (IHECSBE). Sensitivity data files for approximately 400 such models are currently available. The VALID procedure and library continue fulfilling these multiple roles. The VALID procedure is based on the quality assurance principles of ISO 9001 and nuclear safety analysis. Some of these key concepts include: independent generation and review of information, generation and review by qualified individuals, use of appropriate references for design data and documentation, and retrievability of the models, results, and documentation associated with entries in the library. Some highlights of the detailed procedure are discussed to provide background on its implementation and to indicate limitations of data extracted from VALID for use by the broader community. Specifically, external users of data generated within VALID must take responsibility for ensuring that the files are used within the QA framework of their organization and that use is appropriate. The future plans for the VALID library include expansion to include additional experiments from the IHECSBE, to include experiments from areas beyond criticality safety, such as reactor physics and shielding, and to include application models. In the future, external SCALE users may also obtain qualification under the VALID procedure and be involved in expanding the library. The VALID library provides a pathway for the criticality safety community to leverage modeling and analysis expertise at ORNL.« less

A Mind for Adventure

ERIC Educational Resources Information Center

Strother, Mark A.

2007-01-01

Formal schooling began centuries before scientists would discover how the brains of children actually learn. Not surprisingly, traditional teaching was often boring and brain antagonistic. But great teachers in every era intuitively recognized what has now been validated by neuroscience: powerful learning is an adventure of the mind. Students,…

Participatory design of a preliminary safety checklist for general practice

PubMed Central

Bowie, Paul; Ferguson, Julie; MacLeod, Marion; Kennedy, Susan; de Wet, Carl; McNab, Duncan; Kelly, Moya; McKay, John; Atkinson, Sarah

2015-01-01

Background The use of checklists to minimise errors is well established in high reliability, safety-critical industries. In health care there is growing interest in checklists to standardise checking processes and ensure task completion, and so provide further systemic defences against error and patient harm. However, in UK general practice there is limited experience of safety checklist use. Aim To identify workplace hazards that impact on safety, health and wellbeing, and performance, and codesign a standardised checklist process. Design and setting Application of mixed methods to identify system hazards in Scottish general practices and develop a safety checklist based on human factors design principles. Method A multiprofessional ‘expert’ group (n = 7) and experienced front-line GPs, nurses, and practice managers (n = 18) identified system hazards and developed and validated a preliminary checklist using a combination of literature review, documentation review, consensus building workshops using a mini-Delphi process, and completion of content validity index exercise. Results A prototype safety checklist was developed and validated consisting of six safety domains (for example, medicines management), 22 sub-categories (for example, emergency drug supplies) and 78 related items (for example, stock balancing, secure drug storage, and cold chain temperature recording). Conclusion Hazards in the general practice work system were prioritised that can potentially impact on the safety, health and wellbeing of patients, GP team members, and practice performance, and a necessary safety checklist prototype was designed. However, checklist efficacy in improving safety processes and outcomes is dependent on user commitment, and support from leaders and promotional champions. Although further usability development and testing is necessary, the concept should be of interest in the UK and internationally. PMID:25918338

A Criteria Standard for Conflict Resolution: A Vision for Guaranteeing the Safety of Self-Separation in NextGen

NASA Technical Reports Server (NTRS)

Munoz, Cesar; Butler, Ricky; Narkawicz, Anthony; Maddalon, Jeffrey; Hagen, George

2010-01-01

Distributed approaches for conflict resolution rely on analyzing the behavior of each aircraft to ensure that system-wide safety properties are maintained. This paper presents the criteria method, which increases the quality and efficiency of a safety assurance analysis for distributed air traffic concepts. The criteria standard is shown to provide two key safety properties: safe separation when only one aircraft maneuvers and safe separation when both aircraft maneuver at the same time. This approach is complemented with strong guarantees of correct operation through formal verification. To show that an algorithm is correct, i.e., that it always meets its specified safety property, one must only show that the algorithm satisfies the criteria. Once this is done, then the algorithm inherits the safety properties of the criteria. An important consequence of this approach is that there is no requirement that both aircraft execute the same conflict resolution algorithm. Therefore, the criteria approach allows different avionics manufacturers or even different airlines to use different algorithms, each optimized according to their own proprietary concerns.

Constellation Probabilistic Risk Assessment (PRA): Design Consideration for the Crew Exploration Vehicle

NASA Technical Reports Server (NTRS)

Prassinos, Peter G.; Stamatelatos, Michael G.; Young, Jonathan; Smith, Curtis

2010-01-01

Managed by NASA's Office of Safety and Mission Assurance, a pilot probabilistic risk analysis (PRA) of the NASA Crew Exploration Vehicle (CEV) was performed in early 2006. The PRA methods used follow the general guidance provided in the NASA PRA Procedures Guide for NASA Managers and Practitioners'. Phased-mission based event trees and fault trees are used to model a lunar sortie mission of the CEV - involving the following phases: launch of a cargo vessel and a crew vessel; rendezvous of these two vessels in low Earth orbit; transit to th$: moon; lunar surface activities; ascension &om the lunar surface; and return to Earth. The analysis is based upon assumptions, preliminary system diagrams, and failure data that may involve large uncertainties or may lack formal validation. Furthermore, some of the data used were based upon expert judgment or extrapolated from similar componentssystemsT. his paper includes a discussion of the system-level models and provides an overview of the analysis results used to identify insights into CEV risk drivers, and trade and sensitivity studies. Lastly, the PRA model was used to determine changes in risk as the system configurations or key parameters are modified.