Safety Cases and Safety Reports


Book Description

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.




Safety Cases and Safety Reports


Book Description

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.




Offshore Safety Management


Book Description

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.




Evidence


Book Description




Clinical Case Studies on Medication Safety


Book Description

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


Book Description

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


Book Description

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




Safety-I and Safety-II


Book Description

Safety has traditionally been defined as a condition where the number of adverse outcomes was as low as possible (Safety-I). From a Safety-I perspective, the purpose of safety management is to make sure that the number of accidents and incidents is kept as low as possible, or as low as is reasonably practicable. This means that safety management must start from the manifestations of the absence of safety and that - paradoxically - safety is measured by counting the number of cases where it fails rather than by the number of cases where it succeeds. This unavoidably leads to a reactive approach based on responding to what goes wrong or what is identified as a risk - as something that could go wrong. Focusing on what goes right, rather than on what goes wrong, changes the definition of safety from ’avoiding that something goes wrong’ to ’ensuring that everything goes right’. More precisely, Safety-II is the ability to succeed under varying conditions, so that the number of intended and acceptable outcomes is as high as possible. From a Safety-II perspective, the purpose of safety management is to ensure that as much as possible goes right, in the sense that everyday work achieves its objectives. This means that safety is managed by what it achieves (successes, things that go right), and that likewise it is measured by counting the number of cases where things go right. In order to do this, safety management cannot only be reactive, it must also be proactive. But it must be proactive with regard to how actions succeed, to everyday acceptable performance, rather than with regard to how they can fail, as traditional risk analysis does. This book analyses and explains the principles behind both approaches and uses this to consider the past and future of safety management practices. The analysis makes use of common examples and cases from domains such as aviation, nuclear power production, process management and health care. The final chapters explain the theoret




Introduction to Oil and Gas Operational Safety


Book Description

Introduction to Oil and Gas Operational Safety is aligned directly to the NEBOSH International Technical Certificate in Oil and Gas Operational Safety. Concisely written by a highly experienced team, this full colour reference provides complete coverage of the syllabus, including chapters on fire hazards, risk management and emergency response. It will ensure that you are fully equipped with the knowledge and understanding to respond and deal with the daily hazards you may face whilst working in the oil and gas industry. Complete with tables, case studies and self-test questions, this book will guide you through the principles of how to manage both offshore and onshore operational risks to prepare you for your exam and beyond.




Registries for Evaluating Patient Outcomes


Book Description

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.