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.
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.
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 theoretical and practical consequences of the new perspective on the level of day-to-day operations as well as on the level of strategic management (safety culture). Safety-I and Safety-II is written for all professionals responsible for their organisation's safety, from strategic planning on the executive level to day-to-day operations in the field. It presents the detailed and tested arguments for a transformation from protective to productive safety management.
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 AIDS--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 consequence--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 agenda--with state and local implications--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 errors--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 care--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 advocates--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
Medical by Agency for Healthcare Research and Quality/AHRQ
Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
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.
Excerpt from Annual Report of the Sub-Department of Health, Department of Public Safety, to the Mayor and City Council of Baltimore: For the Fiscal Year Ended December 31, 1902 To Show still further the pandemic of smallpox, I will add the following from the United States Marine Hospital weekly reports, which shows the minimum number of cases. The year 1899 added thirteen states to the above list. The grand total of cases for the year was The year 1900 added five more States and territories, making forty-eight in all; the grand total number of cases for the year was The year 1901 added one more to the list, making forty-nine States and territories infected, with a total number of cases for the year of The year 1902 showed for the year cases. During the four years we find every State and territory invaded. About the Publisher Forgotten Books publishes hundreds of thousands of rare and classic books. Find more at www.forgottenbooks.com This book is a reproduction of an important historical work. Forgotten Books uses state-of-the-art technology to digitally reconstruct the work, preserving the original format whilst repairing imperfections present in the aged copy. In rare cases, an imperfection in the original, such as a blemish or missing page, may be replicated in our edition. We do, however, repair the vast majority of imperfections successfully; any imperfections that remain are intentionally left to preserve the state of such historical works.
Statement of Marcia Crosse, Dir., Health Care, GAO. In 2004, several high-profile drug safety cases raised concerns about the Food & Drug Admin.¿s (FDA) ability to manage postmarket drug safety issues. In some cases there were disagreements within FDA about how to address these issues. GAO was asked to testify on the effectiveness of FDA¿s postmarket decision-making process. This testimony is based on the GAO report, ¿Drug Safety: Improvement Needed in FDA¿s Postmarket Decisionmaking & Oversight Process,¿ which focused on the complex interaction between the two offices within FDA that are involved in postmarket drug safety activities: the Office of New Drugs (OND), & the Office of Drug Safety (ODS). OND¿s primary responsibility is to review new drug applications, but it is also involved in monitoring the safety of marketed drugs. ODS is focused primarily on postmarket drug safety issues. ODS is now called the Office of Surveillance & Epidemiology.
Railroad accidents by United States. Interstate Commerce Commission. Bureau of Railroad Safety and Service. Section of Railroad Safety
The substantial burden of death and disability that results from interpersonal violence, road traffic injuries, unintentional injuries, occupational health risks, air pollution, climate change, and inadequate water and sanitation falls disproportionally on low- and middle-income countries. Injury Prevention and Environmental Health addresses the risk factors and presents updated data on the burden, as well as economic analyses of platforms and packages for delivering cost-effective and feasible interventions in these settings. The volume's contributors demonstrate that implementation of a range of prevention strategies-presented in an essential package of interventions and policies-could achieve a convergence in death and disability rates that would avert more than 7.5 million deaths a year.
Railroads by India. Ministry of Tourism and Civil Aviation. Commission of Railway Safety
A new approach to safety, based on systems thinking, that is more effective, less costly, and easier to use than current techniques. Engineering has experienced a technological revolution, but the basic engineering techniques applied in safety and reliability engineering, created in a simpler, analog world, have changed very little over the years. In this groundbreaking book, Nancy Leveson proposes a new approach to safety—more suited to today's complex, sociotechnical, software-intensive world—based on modern systems thinking and systems theory. Revisiting and updating ideas pioneered by 1950s aerospace engineers in their System Safety concept, and testing her new model extensively on real-world examples, Leveson has created a new approach to safety that is more effective, less expensive, and easier to use than current techniques. Arguing that traditional models of causality are inadequate, Leveson presents a new, extended model of causation (Systems-Theoretic Accident Model and Processes, or STAMP), then shows how the new model can be used to create techniques for system safety engineering, including accident analysis, hazard analysis, system design, safety in operations, and management of safety-critical systems. She applies the new techniques to real-world events including the friendly-fire loss of a U.S. Blackhawk helicopter in the first Gulf War; the Vioxx recall; the U.S. Navy SUBSAFE program; and the bacterial contamination of a public water supply in a Canadian town. Leveson's approach is relevant even beyond safety engineering, offering techniques for “reengineering” any large sociotechnical system to improve safety and manage risk.
The safety case and its associated reports are becoming a mechanism for achieving safety goals, a valuable decision-support asset and a vital industrial liability management tool. This book 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.
Technology & Engineering by Jean-Christophe Le Coze
Safety Science Research: Evolution, Challenges and New Directions provides a unique perspective into the latest developments of safety science by putting together, for the first time, a new generation of authors with some of the pioneers of the field. Forty years ago, research traditions were developed, including, among others, high-reliability organisations, cognitive system engineering or safety regulations. In a fast-changing world, the new generation introduces, in this book, new disciplinary insights, addresses contemporary empirical issues, develops new concepts and models while remaining critical of safety research practical ambitions. Their ideas are then reflected and discussed by some of the pioneers of safety science. Features Allows the reader to discover how contemporary safety issues are currently framed by a new generation of researchers, brought together for the first time Includes an introduction and guide to the development of safety science over the last four decades Features an extraordinary collection of expert contributors, including pioneers of safety research, reflecting the evolution of the discipline and offering insightful commentary on the current and future state of the field Serves as an invaluable reference and guide for safety professionals and students from any established disciplines such as sociology, engineering, psychology, political science or management as well as dedicated safety programmes Some figures in the eBook are in colour
Pharmacovigilance Made Easy is a compilation of all the material which is essential to understand and practice the concepts of Pharmacovigilance and Patient Safety for Freshers who wish to swim on the surface as well as for Experienced Professional's who wishes to dive deeper. It also contains a compilation of the most frequently asked interview questions in the domain of Pharmacovigilance.
The U.S. Government Accountability Office (GAO) is an independent agency that works for Congress. The GAO watches over Congress, and investigates how the federal government spends taxpayers dollars. The Comptroller General of the United States is the leader of the GAO, and is appointed to a 15-year term by the U.S. President. The GAO wants to support Congress, while at the same time doing right by the citizens of the United States. They audit, investigate, perform analyses, issue legal decisions and report anything that the government is doing. This is one of their reports.