Transparency and Public Reporting Are Essential for a Safe Health Care System

Compares three approaches to spurring hospitals to improve patient safety and argues that public reporting of performance and feedback to providers is more effective than regulation and accreditation or financial incentives

Making Healthcare Safe

This unique and engaging open access title provides a compelling and ground-breaking account of the patient safety movement in the United States, told from the perspective of one of its most prominent leaders, and arguably the movement’s founder, Lucian L. Leape, MD. Covering the growth of the field from the late 1980s to 2015, Dr. Leape details the developments, actors, organizations, research, and policy-making activities that marked the evolution and major advances of patient safety in this time span. In addition, and perhaps most importantly, this book not only comprehensively details how and why human and systems errors too often occur in the process of providing health care, it also promotes an in-depth understanding of the principles and practices of patient safety, including how they were influenced by today’s modern safety sciences and systems theory and design. Indeed, the book emphasizes how the growing awareness of systems-design thinking and the self-education and commitment to improving patient safety, by not only Dr. Leape but a wide range of other clinicians and health executives from both the private and public sectors, all converged to drive forward the patient safety movement in the US. Making Healthcare Safe is divided into four parts: I. In the Beginning describes the research and theory that defined patient safety and the early initiatives to enhance it. II. Institutional Responses tells the stories of the efforts of the major organizations that began to apply the new concepts and make patient safety a reality. Most of these stories have not been previously told, so this account becomes their histories as well. III. Getting to Work provides in-depth analyses of four key issues that cut across disciplinary lines impacting patient safety which required special attention. IV. Creating a Culture of Safety looks to the future, marshalling the best thinking about what it will take to achieve the safe care we all deserve. Captivatingly written with an “insider’s” tone and a major contribution to the clinical literature, this title will be of immense value to health care professionals, to students in a range of academic disciplines, to medical trainees, to health administrators, to policymakers and even to lay readers with an interest in patient safety and in the critical quest to create safe care

Implementing the 2009 Institute of Medicine recommendations on resident physician work hours, supervision, and safety

Long working hours and sleep deprivation have been a facet of physician training in the US since the advent of the modern residency system. However, the scientific evidence linking fatigue with deficits in human performance, accidents and errors in industries from aeronautics to medicine, nuclear power, and transportation has mounted over the last 40 years. This evidence has also spawned regulations to help ensure public safety across safety-sensitive industries, with the notable exception of medicine. In late 2007, at the behest of the US Congress, the Institute of Medicine embarked on a year-long examination of the scientific evidence linking resident physician sleep deprivation with clinical performance deficits and medical errors. The Institute of Medicine’s report, entitled “Resident duty hours: Enhancing sleep, supervision and safety”, published in January 2009, recommended new limits on resident physician work hours and workload, increased supervision, a heightened focus on resident physician safety, training in structured handovers and quality improvement, more rigorous external oversight of work hours and other aspects of residency training, and the identification of expanded funding sources necessary to implement the recommended reforms successfully and protect the public and resident physicians themselves from preventable harm. Given that resident physicians comprise almost a quarter of all physicians who work in hospitals, and that taxpayers, through Medicare and Medicaid, fund graduate medical education, the public has a deep investment in physician training. Patients expect to receive safe, high-quality care in the nation’s teaching hospitals. Because it is their safety that is at issue, their voices should be central in policy decisions affecting patient safety. It is likewise important to integrate the perspectives of resident physicians, policy makers, and other constituencies in designing new policies. However, since its release, discussion of the Institute of Medicine report has been largely confined to the medical education community, led by the Accreditation Council for Graduate Medical Education (ACGME). To begin gathering these perspectives and developing a plan to implement safer work hours for resident physicians, a conference entitled “Enhancing sleep, supervision and safety: What will it take to implement the Institute of Medicine recommendations?” was held at Harvard Medical School on June 17–18, 2010. This White Paper is a product of a diverse group of 26 representative stakeholders bringing relevant new information and innovative practices to bear on a critical patient safety problem. Given that our conference included experts from across disciplines with diverse perspectives and interests, not every recommendation was endorsed by each invited conference participant. However, every recommendation made here was endorsed by the majority of the group, and many were endorsed unanimously. Conference members participated in the process, reviewed the final product, and provided input before publication. Participants provided their individual perspectives, which do not necessarily represent the formal views of any organization. In September 2010 the ACGME issued new rules to go into effect on July 1, 2011. Unfortunately, they stop considerably short of the Institute of Medicine’s recommendations and those endorsed by this conference. In particular, the ACGME only applied the limitation of 16 hours to first-year resident physicans. Thus, it is clear that policymakers, hospital administrators, and residency program directors who wish to implement safer health care systems must go far beyond what the ACGME will require. We hope this White Paper will serve as a guide and provide encouragement for that effort. Resident physician workload and supervision By the end of training, a resident physician should be able to practice independently. Yet much of resident physicians’ time is dominated by tasks with little educational value. The caseload can be so great that inadequate reflective time is left for learning based on clinical experiences. In addition, supervision is often vaguely defined and discontinuous. Medical malpractice data indicate that resident physicians are frequently named in lawsuits, most often for lack of supervision. The recommendations are: The ACGME should adjust resident physicians workload requirements to optimize educational value. Resident physicians as well as faculty should be involved in work redesign that eliminates nonessential and noneducational activity from resident physician dutiesMechanisms should be developed for identifying in real time when a resident physician’s workload is excessive, and processes developed to activate additional providersTeamwork should be actively encouraged in delivery of patient care. Historically, much of medical training has focused on individual knowledge, skills, and responsibility. As health care delivery has become more complex, it will be essential to train resident and attending physicians in effective teamwork that emphasizes collective responsibility for patient care and recognizes the signs, both individual and systemic, of a schedule and working conditions that are too demanding to be safeHospitals should embrace the opportunities that resident physician training redesign offers. Hospitals should recognize and act on the potential benefits of work redesign, eg, increased efficiency, reduced costs, improved quality of care, and resident physician and attending job satisfactionAttending physicians should supervise all hospital admissions. Resident physicians should directly discuss all admissions with attending physicians. Attending physicians should be both cognizant of and have input into the care patients are to receive upon admission to the hospitalInhouse supervision should be required for all critical care services, including emergency rooms, intensive care units, and trauma services. Resident physicians should not be left unsupervised to care for critically ill patients. In settings in which the acuity is high, physicians who have completed residency should provide direct supervision for resident physicians. Supervising physicians should always be physically in the hospital for supervision of resident physicians who care for critically ill patientsThe ACGME should explicitly define “good” supervision by specialty and by year of training. Explicit requirements for intensity and level of training for supervision of specific clinical scenarios should be providedCenters for Medicare and Medicaid Services (CMS) should use graduate medical education funding to provide incentives to programs with proven, effective levels of supervision. Although this action would require federal legislation, reimbursement rules would help to ensure that hospitals pay attention to the importance of good supervision and require it from their training programs Resident physician work hours Although the IOM “Sleep, supervision and safety” report provides a comprehensive review and discussion of all aspects of graduate medical education training, the report’s focal point is its recommendations regarding the hours that resident physicians are currently required to work. A considerable body of scientific evidence, much of it cited by the Institute of Medicine report, describes deteriorating performance in fatigued humans, as well as specific studies on resident physician fatigue and preventable medical errors. The question before this conference was what work redesign and cultural changes are needed to reform work hours as recommended by the Institute of Medicine’s evidence-based report? Extensive scientific data demonstrate that shifts exceeding 12–16 hours without sleep are unsafe. Several principles should be followed in efforts to reduce consecutive hours below this level and achieve safer work schedules. The recommendations are: Limit resident physician work hours to 12–16 hour maximum shiftsA minimum of 10 hours off duty should be scheduled between shiftsResident physician input into work redesign should be actively solicitedSchedules should be designed that adhere to principles of sleep and circadian science; this includes careful consideration of the effects of multiple consecutive night shifts, and provision of adequate time off after night work, as specified in the IOM reportResident physicians should not be scheduled up to the maximum permissible limits; emergencies frequently occur that require resident physicians to stay longer than their scheduled shifts, and this should be anticipated in scheduling resident physicians’ work shiftsHospitals should anticipate the need for iterative improvement as new schedules are initiated; be prepared to learn from the initial phase-in, and change the plan as neededAs resident physician work hours are redesigned, attending physicians should also be considered; a potential consequence of resident physician work hour reduction and increased supervisory requirements may be an increase in work for attending physicians; this should be carefully monitored, and adjustments to attending physician work schedules made as needed to prevent unsafe work hours or working conditions for this group“Home call” should be brought under the overall limits of working hours; work load and hours should be monitored in each residency program to ensure that resident physicians and fellows on home call are getting sufficient sleepMedicare funding for graduate medical education in each hospital should be linked with adherence to the Institute of Medicine limits on resident physician work hours Moonlighting by resident physicians The Institute of Medicine report recommended including external as well as internal moonlighting in working hour limits. The recommendation is: All moonlighting work hours should be included in the ACGME working hour limits and actively monitored. Hospitals should formalize a moonlighting policy and establish systems for actively monitoring resident physician moonlighting Safety of resident physicians The “Sleep, supervision and safety” report also addresses fatigue-related harm done to resident physicians themselves. The report focuses on two main sources of physical injury to resident physicians impaired by fatigue, ie, needle-stick exposure to blood-borne pathogens and motor vehicle crashes. Providing safe transportation home for resident physicians is a logistical and financial challenge for hospitals. Educating physicians at all levels on the dangers of fatigue is clearly required to change driving behavior so that safe hospital-funded transport home is used effectively. Fatigue-related injury prevention (including not driving while drowsy) should be taught in medical school and during residency, and reinforced with attending physicians; hospitals and residency programs must be informed that resident physicians’ ability to judge their own level of impairment is impaired when they are sleep deprived; hence, leaving decisions about the capacity to drive to impaired resident physicians is not recommendedHospitals should provide transportation to all resident physicians who report feeling too tired to drive safely; in addition, although consecutive work should not exceed 16 hours, hospitals should provide transportation for all resident physicians who, because of unforeseen reasons or emergencies, work for longer than consecutive 24 hours; transportation under these circumstances should be automatically provided to house staff, and should not rely on self-identification or request Training in effective handovers and quality improvement Handover practice for resident physicians, attendings, and other health care providers has long been identified as a weak link in patient safety throughout health care settings. Policies to improve handovers of care must be tailored to fit the appropriate clinical scenario, recognizing that information overload can also be a problem. At the heart of improving handovers is the organizational effort to improve quality, an effort in which resident physicians have typically been insufficiently engaged. The recommendations are: Hospitals should train attending and resident physicians in effective handovers of careHospitals should create uniform processes for handovers that are tailored to meet each clinical setting; all handovers should be done verbally and face-to-face, but should also utilize written toolsWhen possible, hospitals should integrate hand-over tools into their electronic medical records (EMR) systems; these systems should be standardized to the extent possible across residency programs in a hospital, but may be tailored to the needs of specific programs and services; federal government should help subsidize adoption of electronic medical records by hospitals to improve signoutWhen feasible, handovers should be a team effort including nurses, patients, and familiesHospitals should include residents in their quality improvement and patient safety efforts; the ACGME should specify in their core competency requirements that resident physicians work on quality improvement projects; likewise, the Joint Commission should require that resident physicians be included in quality improvement and patient safety programs at teaching hospitals; hospital administrators and residency program directors should create opportunities for resident physicians to become involved in ongoing quality improvement projects and root cause analysis teams; feedback on successful quality improvement interventions should be shared with resident physicians and broadly disseminatedQuality improvement/patient safety concepts should be integral to the medical school curriculum; medical school deans should elevate the topics of patient safety, quality improvement, and teamwork; these concepts should be integrated throughout the medical school curriculum and reinforced throughout residency; mastery of these concepts by medical students should be tested on the United States Medical Licensing Examination (USMLE) stepsFederal government should support involvement of resident physicians in quality improvement efforts; initiatives to improve quality by including resident physicians in quality improvement projects should be financially supported by the Department of Health and Human Services Monitoring and oversight of the ACGME While the ACGME is a key stakeholder in residency training, external voices are essential to ensure that public interests are heard in the development and monitoring of standards. Consequently, the Institute of Medicine report recommended external oversight and monitoring through the Joint Commission and Centers for Medicare and Medicaid Services (CMS). The recommendations are: Make comprehensive fatigue management a Joint Commission National Patient Safety Goal; fatigue is a safety concern not only for resident physicians, but also for nurses, attending physicians, and other health care workers; the Joint Commission should seek to ensure that all health care workers, not just resident physicians, are working as safely as possibleFederal government, including the Centers for Medicare and Medicaid Services and the Agency for Healthcare Research and Quality, should encourage development of comprehensive fatigue management programs which all health systems would eventually be required to implementMake ACGME compliance with working hours a “ condition of participation” for reimbursement of direct and indirect graduate medical education costs; financial incentives will greatly increase the adoption of and compliance with ACGME standards Future financial support for implementation The Institute of Medicine’s report estimates that $1.7 billion (in 2008 dollars) would be needed to implement its recommendations. Twenty-five percent of that amount ($376 million) will be required just to bring hospitals into compliance with the existing 2003 ACGME rules. Downstream savings to the health care system could potentially result from safer care, but these benefits typically do not accrue to hospitals and residency programs, who have been asked historically to bear the burden of residency reform costs. The recommendations are: The Institute of Medicine should convene a panel of stakeholders, including private and public funders of health care and graduate medical education, to lay down the concrete steps necessary to identify and allocate the resources needed to implement the recommendations contained in the IOM “Resident duty hours: Enhancing sleep, supervision and safety” report. Conference participants suggested several approaches to engage public and private support for this initiativeEfforts to find additional funding to implement the Institute of Medicine recommendations should focus more broadly on patient safety and health care delivery reform; policy efforts focused narrowly upon resident physician work hours are less likely to succeed than broad patient safety initiatives that include residency redesign as a key componentHospitals should view the Institute of Medicine recommendations as an opportunity to begin resident physician work redesign projects as the core of a business model that embraces safety and ultimately saves resourcesBoth the Secretary of Health and Human Services and the Director of the Centers for Medicare and Medicaid Services should take the Institute of Medicine recommendations into consideration when promulgating rules for innovation grantsThe National Health Care Workforce Commission should consider the Institute of Medicine recommendations when analyzing the nation’s physician workforce needs Recommendations for future research Conference participants concurred that convening the stakeholders and agreeing on a research agenda was key. Some observed that some sectors within the medical education community have been reluctant to act on the data. Several logical funders for future research were identified. But above all agencies, Centers for Medicare and Medicaid Services is the only stakeholder that funds graduate medical education upstream and will reap savings downstream if preventable medical errors are reduced as a result of reform of resident physician work hours

Međunarodni propisi o farmaceutskom društvenom riziku: Etičko gledište

Pharmaceutical production and distribution constitute big business. For the companies the rewards can be substantial. Rates of return on drug company investments tend to be higher than many other manufacturing enterprises. But reward is only one side of the story. There is also the issue of social risk, the focus of this article. Social risk for pharmaceutical production is especially pronounced. An ineffective or, worse, dangerous drug, can have dire consequences for the population at large. For this reason, there is elaborate government regulation and oversight of drug safety and risk. These systems, especially in the US and Europe, will be the main focus of this paper. The two systems will be described, and then compared and contrasted in terms of their framing of social risk and actions governments take to limit it. Systems elsewhere, especially in the developing world, are increasing in relative importance and these will be briefly discussed as well. Ethical issues that have arisen in these various systems will be surfaced and analysed. The paper will close with some conclusions and suggestions for further research.Proizvodnja i distribucija lijekova vrlo je unosan posao. Za djelovanje farmaceutskih tvrtki bitna je dobit. Financijska ulaganja i povrat investicija u farmaceutskoj industriji veći su nego u drugim djelatnostima. Ali profit je samo jedna strana priče. Postoji i veliki društveni rizik, o čemu će biti riječi u ovom članku. Društveni rizik u farmaceutskoj proizvodnji je posebno naglašen. Neučinkoviti, ili još gore, opasni lijekovi, mogu imati pogubne posljedice za cijelo stanovništvo. Zbog toga na državnoj razini postoji regulativa i nadzor nad sigurnosti i rizikom uporabe lijekova. Ti sustavi, posebno sustavi u SAD-u i Europi, u fokusu su ovog članka. Ta su dva nadzorna sustava opisana i uspoređena u svjetlu ograničavanja društvenog rizika i mjera koje vlade poduzimaju kako bi ih ograničile. Drugi sustavi, posebice u zemljama u razvoju, dobivaju sve više na značaju i ukratko su opisani. Prikazani su i analizirani etički principi u drugim sustavima. Rad završava sa zaključcima i prijedlozima za daljnja istraživanja

Overestimating Outcome Rates: Statistical Estimation When Reliability Is Suboptimal

To demonstrate how failure to account for measurement error in an outcome (dependent) variable can lead to significant estimation errors and to illustrate ways to recognize and avoid these errors. Data Sources . Medical literature and simulation models. Study Design/Data Collection . Systematic review of the published and unpublished epidemiological literature on the rate of preventable hospital deaths and statistical simulation of potential estimation errors based on data from these studies. Principal Findings . Most estimates of the rate of preventable deaths in U.S. hospitals rely upon classifying cases using one to three physician reviewers (implicit review). Because this method has low to moderate reliability, estimates based on statistical methods that do not account for error in the measurement of a “preventable death” can result in significant overestimation. For example, relying on a majority rule rating with three reviewers per case (reliability ∼0.45 for the average of three reviewers) can result in a 50–100 percent overestimation compared with an estimate based upon a reliably measured outcome (e.g., by using 50 reviewers per case). However, there are statistical methods that account for measurement error that can produce much more accurate estimates of outcome rates without requiring a large number of measurements per case. Conclusion . The statistical principles discussed in this case study are critically important whenever one seeks to estimate the proportion of cases belonging to specific categories (such as estimating how many patients have inadequate blood pressure control or identifying high-cost or low-quality physicians). When the true outcome rate is low (<20 percent), using an outcome measure that has low-to-moderate reliability will generally result in substantially overestimating the proportion of the population having the outcome unless statistical methods that adjust for measurement error are used.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/74896/1/j.1475-6773.2006.00661.x.pd

Survival enhancing indications for coronary artery bypass graft surgery in California

<p>Abstract</p> <p>Background</p> <p>Coronary artery bypass graft (CABG) surgery is performed because of anticipated survival benefit, improvement in quality of life, or both. We performed this study to explore variations in clinical indications for CABG surgery among California hospitals and surgeons.</p> <p>Methods</p> <p>Using California CABG Outcomes Reporting Program data, we classified all isolated CABG cases in 2003–2004 as having "probable survival enhancing indications (SEIs)", "possible SEIs" or "non-SEIs." Patient and hospital characteristics associated with SEIs were examined.</p> <p>Results</p> <p>While 82.9% of CABG were performed for probable SEIs, the range extended from 68% to 96% among hospitals and 51% to 100% among surgeons. SEI rates were higher among patients aged ≥ 65 compared with those aged 18–64 (Adjusted Odds Ratio [AOR] > 1.29 for age groups 65–69, 70–74 and ≥ 75; all p < 0.001), among Asians and Native Americans compared with Caucasians (AOR 1.22 and 1.15, p < 0.001); and among patients with hypertension, peripheral vascular disease, diabetes, cerebrovascular disease and congestive heart failure compared to patients without these conditions (AOR > 1.09, all p < 0.001). Variations in indications for surgery were more strongly related to patient mix than to surgeon or hospital effects (intraclass correlation [ICC] = 0.04 for hospital; ICC = 0.01 for surgeon).</p> <p>Conclusion</p> <p>California hospitals and surgeons vary in their distribution of indications for CABG surgery. Further research is required to identify the roles of market factors, referral patterns, patient preferences, and local clinical culture in producing the observed variations.</p

Medical error in the portuguese press: when patients are part of the news

Esta investigação aborda a qualidade da produção noticiosa sobre o erro médico, como um fator essencial na construção do conhecimento público sobre o tema, com o objetivo de compreender que características definem tal produção e até que ponto poderão ser explicadas pela periodicidade e orientação editorial dos jornais; que conceito de erro médico é veiculado pela produção noticiosa sobre o tema; e quais são os protagonistas no discurso jornalístico sobre o erro médico. Foram analisadas as edições de três jornais portugueses, de 2008 a 2011, resultando num corpus de 266 (4,2%) artigos, que foram classificados de acordo com as seguintes variáveis: as fontes de informação citadas (o seu estatuto e especialidade, no caso dos médicos); os temas que são tratados; as características de enquadramento da informação publicada (tom, género jornalístico; e a presença e número de fontes de informação). Pela análise de conteúdo quantitativa, apurou-se que esse tema está em crescimento, essencialmente com notícias de tom negativo e fontes de informação habitualmente identificadas. Não há evidência para afirmar que a periodicidade e a orientação editorial expliquem as variações dessas características, a não ser relativamente ao número de fontes citadas. Vigoram as notícias centradas nos resultados dos erros (mortes ou lesões), provocados por "erros de omissão" e por "erros de comissão", envolvendo uma diversidade de protagonistas: são, tal como acontece na informação sobre saúde em geral, fontes oficiais e especializadas do campo da saúde. Destacam-se os médicos e os juristas e é dado relevo aos pacientes.This research addresses the quality of news production on medical error, as an essential factor in building public knowledge on the subject, in order to understand which characteristics define the news production of medical error and to what extent can they be explained by the periodicity and editorial orientation of the newspaper; which concept of medical error is transmitted by the news production on the subject; and who are the main actors in the journalistic discourse about medical error. The editions of three Portuguese newspapers were analyzed, from 2008 to 2011, resulting in a corpus of 266 (4.2%) articles, which were classified according to the following variables: the sources of information quoted (their status and specialty, in the case of doctors); the issues covered; and characteristic framework of the published information (tone, journalistic style, and the presence and number of information sources). Through quantitative content analysis, it was found that this topic is growing, essentially with negative news and information sources usually being identified. There is no evidence to support that periodicity and editorial orientation explain the variations in these characteristics, except for the number of cited sources. News focused on the results of errors (death or injury), caused by "errors of omission" and "commission errors", prevail, involving a variety of actors: they are, such as it happens in health information, in general, official sources and experts in health. Doctors and lawyers stand out, and special attention is given to patients

Unlearning and patient safety

This chapter adds to the growing body of literature on unlearning by contributing a model applicable to the context of professional organisations, and more specifically to healthcare and patient safety. An overview of the global patient safety agenda is described and a gap in implementing sustained safety improvement identified. The UK’s efforts to bridge this gap in patient safety by transforming their NHS into a ‘learning organisation’ are discussed. The unlearning literature is reviewed and an updated model of unlearning conceptualized that contains three dimensions relevant to the study of professionals: cognitive, cultural and political. As a research agenda, this chapter provides a starting point for thinking about how unlearning can be studied in organisations; establishing a theoretical foundation for future study

A hazard analysis method for systematic identification of safety requirements for user interface software in medical devices

© Springer International Publishing AG (outside the US) 2017. Formal methods technologies have the potential to verify the usability and safety of user interface (UI) software design in medical devices, enabling significant reductions in use errors and consequential safety incidents with such devices. This however depends on comprehensive and verifiable safety requirements to leverage these techniques for detecting and preventing flaws in UI software that can induce use errors. This paper presents a hazard analysis method that extends Leveson’s System Theoretic Process Analysis (STPA) with a comprehensive set of causal factor categories, so as to provide developers with clear guidelines for systematic identification of use-related hazards associated with medical devices, their causes embedded in UI software design, and safety requirements for mitigating such hazards. The method is evaluated with a case study on the Gantry-2 radiation therapy system, which demonstrates that (1) as compared to standard STPA, our method allowed us to identify more UI software design issues likely to cause use-related hazards; and (2) the identified UI software design issues facilitated the definition of precise, verifiable safety requirements for UI software, which could be readily formalized in verification tools such as Prototype Verification System (PVS).- U.S. Food and Drug Administration(NORTE-01-0145-FEDER-000016)Sandy Weininger (FDA), Scott Thiel (Navigant Consulting, Inc.), Michelle Jump (Stryker), Stefania Gnesi (ISTI/CNR) and the CHI+MED team (www.chi-med.ac.uk) provided useful feedback and inputs. Paolo Masci’s work is supported by the North Portugal Regional Operational Programme (NORTE 2020) under the PORTUGAL 2020 Partnership Agreement, and by the European Regional Development Fund (ERDF) within Project “NORTE-01-0145-FEDER-000016”.info:eu-repo/semantics/publishedVersio