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Safety Cases and Safety Reports

Safety Cases and Safety Reports
Author: Richard Maguire
Publisher: CRC Press
Total Pages: 148
Release: 2017-05-15
Genre: Technology & Engineering
ISBN: 1317059883

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The safety case and its associated reports are quickly becoming not only a mechanism for achieving safety goals, but also a valuable decision-support asset, and a vital industrial liability management tool. Recent developments in industry have led to safety cases being frequently required as contractual deliverables as part of large and complex commercial programmes. A safety case consists of a rational argument and detailed evidence to justify and demonstrate that a system or product is tolerably safe in its use, and that it has a management programme to ensure that this remains so. The safety case report is the snap-shot presentation of the arguments and evidence demonstrating the contemporary safety performance of the system and the programme that is in place. This book, written from personal experience and reference, provides a concentrated source document for assessing and constructing safety cases and safety case reports - from understanding their purposes, through their development and on to their presentation.


Evidence

Evidence
Author: George M. Cleland
Publisher: The Health Foundation
Total Pages: 44
Release: 2012
Genre: Health services administration
ISBN: 1906461430

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Offshore Safety Management

Offshore Safety Management
Author: Ian Sutton
Publisher: William Andrew
Total Pages: 297
Release: 2011-10-11
Genre: Science
ISBN: 1437735258

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2010 was a defining year for the offshore oil and gas industry in the United States. On April 20, 2010, the Deepwater Horizon (DWH) floating drilling rig suffered a catastrophic explosion and fire. Eleven men died in the explosion — 17 others were injured. The fire, which burned for a day and a half, eventually sent the entire rig to the bottom of the sea. The extent of the spill was enormous, and the environmental damage is still being evaluated. Following DWH the Bureau of Ocean Energy Management, Regulations and Enforcement (BOEMRE) issued many new regulations. One of them is the Safety and Environmental System (SEMS) rule, which is based on the American Petroleum Institute’s SEMP recommended practice. Companies have to be in full compliance with its extensive requirements by November 15, 2011.


The Role of Safety Reports in Preventing Accidents

The Role of Safety Reports in Preventing Accidents
Author:
Publisher:
Total Pages: 135
Release: 2012
Genre:
ISBN: 9789279262630

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This expert report reflects conclusions and key points from two surveys and a workshop involving Seveso inspectors from around Europe on the role of safety reports in preventing major chemical accidents. The Seveso Directive requires operators of so-called "upper-tier" major hazard sites to submit safety reports detailing the major risks associated with the site and how they are controlled. Safety reports are the documents in which the operator of such a site demonstrates that the major accident prevention policy and a safety management system are in effect, that major accident hazards and risk have been identified and are adequately prevented and potential consequences limited, that adequate safety and reliability is incorporated in all aspects of the plant, and an effective internal emergency plan has been drawn up and implemented. A good safety report allows the authorities to get a clear overview of what could happen, how accidents are prevented and what is being done to ensure that if an accident occurred, the consequences can be minimised and a clear mitigation plan is in place. Ideally, the safety report should also be a dynamic, living document that helps companies control and take into account the potential for major accident hazards in various operational decisions. In many cases, the safety report is, however, still only a report compiled for the authorities. The report indicates that while there are many practical differences in how the Seveso II Directive safety reports are evaluated and used in inspections within the EU and its Seveso partner countries, the challenges are almost universal. Most challenges appear to be related to whether the safety report presents a coherent and convincing case that justifies the risk management decisions taken. The report describes the key challenges, providing several examples of good practice for improving safety reports (operators) and verifying safety reports during inspections (authorities). It also identifies a number of specific areas where it could be useful to develop common tools and solutions to improve overall effectiveness of safety reports as an active and useful mechanism for site risk management.


Clinical Case Studies on Medication Safety

Clinical Case Studies on Medication Safety
Author: Yaser Mohammed Al-Worafi
Publisher: Elsevier
Total Pages: 526
Release: 2023-01-19
Genre: Business & Economics
ISBN: 0323972691

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Clinical Case Studies on Medication Safety provides real and simulated scenarios about safety issues related to medication, including Adverse Drug Reactions (ADRs), medication errors, and Drug Related Problems (DRPs). The book explains real-life case management, including details about adverse drug reactions, mistakes during drug administration, drug avoidance, and drug-drug interactions with a goal of improving patient care. With over 150 case studies, including cases from alternative medicine and traditional medicine, this book will help medical and health sciences educators, students, healthcare professionals, and other readers apply their knowledge and skills to solve cases for better patient care. Includes real and simulated case studies about drug safety issues Aids medical students and practitioners to improve their case solving skills Contains more than 150 case studies with questions and key answers


The Agile Safety Case

The Agile Safety Case
Author: Thor Myklebust
Publisher: Springer
Total Pages: 242
Release: 2018-01-29
Genre: Computers
ISBN: 3319702653

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The safety case (SC) is one of the railway industry’s most important deliverables for creating confidence in their systems. This is the first book on how to write an SC, based on the standard EN 50129:2003. Experience has shown that preparing and understanding an SC is difficult and time consuming, and as such the book provides insights that enhance the training for writing an SC. The book discusses both "regular" safety cases and agile safety cases, which avoid too much documentation, improve communication between the stakeholders, allow quicker approval of the system, and which are important in the light of rapidly changing technology. In addition, it discusses the necessity of frequently updating software due to market requirements, changes in requirements and increased cyber-security threats. After a general introduction to SCs and agile thinking in chapter 1, chapter 2 describes the majority of the roles that are relevant when developing railway-signaling systems. Next, chapter 3 provides information related to the assessment of signaling systems, to certifications based on IEC 61508 and to the authorization of signaling systems. Chapter 4 then explains how an agile safety plan satisfying the requirements given in EN 50126-1:1999 can be developed, while chapter 5 provides a brief introduction to safety case patterns and notations. Lastly, chapter 6 combines all this and describes how an (agile) SC can be developed and what it should include. To ensure that infrastructure managers, suppliers, consultants and others can take full advantage of the agile mind-set, the book includes concrete examples and presents relevant agile practices. Although the scope of the book is limited to signaling systems, the basic foundations for (agile) SCs are clearly described so that they can also be applied in other cases.


To Err Is Human

To Err Is Human
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 312
Release: 2000-03-01
Genre: Medical
ISBN: 0309068371

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Experts estimate that as many as 98,000 people die in any given year from medical errors that occur in hospitals. That's more than die from motor vehicle accidents, breast cancer, or AIDSâ€"three causes that receive far more public attention. Indeed, more people die annually from medication errors than from workplace injuries. Add the financial cost to the human tragedy, and medical error easily rises to the top ranks of urgent, widespread public problems. To Err Is Human breaks the silence that has surrounded medical errors and their consequenceâ€"but not by pointing fingers at caring health care professionals who make honest mistakes. After all, to err is human. Instead, this book sets forth a national agendaâ€"with state and local implicationsâ€"for reducing medical errors and improving patient safety through the design of a safer health system. This volume reveals the often startling statistics of medical error and the disparity between the incidence of error and public perception of it, given many patients' expectations that the medical profession always performs perfectly. A careful examination is made of how the surrounding forces of legislation, regulation, and market activity influence the quality of care provided by health care organizations and then looks at their handling of medical mistakes. Using a detailed case study, the book reviews the current understanding of why these mistakes happen. A key theme is that legitimate liability concerns discourage reporting of errorsâ€"which begs the question, "How can we learn from our mistakes?" Balancing regulatory versus market-based initiatives and public versus private efforts, the Institute of Medicine presents wide-ranging recommendations for improving patient safety, in the areas of leadership, improved data collection and analysis, and development of effective systems at the level of direct patient care. To Err Is Human asserts that the problem is not bad people in health careâ€"it is that good people are working in bad systems that need to be made safer. Comprehensive and straightforward, this book offers a clear prescription for raising the level of patient safety in American health care. It also explains how patients themselves can influence the quality of care that they receive once they check into the hospital. This book will be vitally important to federal, state, and local health policy makers and regulators, health professional licensing officials, hospital administrators, medical educators and students, health caregivers, health journalists, patient advocatesâ€"as well as patients themselves. First in a series of publications from the Quality of Health Care in America, a project initiated by the Institute of Medicine


Advances in Patient Safety

Advances in Patient Safety
Author: Kerm Henriksen
Publisher:
Total Pages: 526
Release: 2005
Genre: Medical
ISBN:

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v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.


Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes
Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
Total Pages: 396
Release: 2014-04-01
Genre: Medical
ISBN: 1587634333

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This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.