Transforming concepts in patient safety: a progress report.

In 2009, the National Patient Safety Foundation's Lucian Leape Institute (LLI) published a paper identifying five areas of healthcare that require system-level attention and action to advance patient safety.The authors argued that to truly transform the safety of healthcare, there was a need to address medical education reform; care integration; restoring joy and meaning in work and ensuring the safety of the healthcare workforce; consumer engagement in healthcare and transparency across the continuum of care. In the ensuing years, the LLI convened a series of expert roundtables to address each concept, look at obstacles to implementation, assess potential for improvement, identify potential implementation partners and issue recommendations for action. Reports of these activities were published between 2010 and 2015. While all five areas have seen encouraging developments, multiple challenges remain. In this paper, the current members of the LLI (now based at the Institute for Healthcare Improvement) assess progress made in the USA since 2009 and identify ongoing challenges.

Safety in numbers: the development of Leapfrog's composite patient safety score for U.S. hospitals.

OBJECTIVE: To develop a composite patient safety score that provides patients, health-care providers, and health-care purchasers with a standardized method to evaluate patient safety in general acute care hospitals in the United States. METHODS: The Leapfrog Group sought guidance from a panel of national patient safety experts to develop the composite score. Candidate patient safety performance measures for inclusion in the score were identified from publicly reported national sources. Hospital performance on each measure was converted into a "z-score" and then aggregated using measure-specific weights. A reference mean score was set at 3, with scores interpreted in terms of standard deviations above or below the mean, with above reflecting better than average performance. RESULTS: Twenty-six measures were included in the score. The mean composite score for 2652 general acute care hospitals in the United States was 2.97 (range by hospital, 0.46-3.94). Safety scores were slightly lower for hospitals that were publicly owned, rural in location, or had a larger percentage of patients with Medicaid as their primary insurance. CONCLUSIONS: The Leapfrog patient safety composite provides a standardized method to evaluate patient safety in general acute care hospitals in the United States. While constrained by available data and publicly reported scores on patient safety measures, the composite score reflects the best available evidence regarding a hospital's efforts and outcomes in patient safety. Additional analyses are needed, but the score did not seem to have a strong bias against hospitals with specific characteristics. The composite score will continue to be refined over time as measures of patient safety evolve.

Perspective: a culture of respect, part 1: the nature and causes of disrespectful behavior by physicians.

A substantial barrier to progress in patient safety is a dysfunctional culture rooted in widespread disrespect. The authors identify a broad range of disrespectful conduct, suggesting six categories for classifying disrespectful behavior in the health care setting: disruptive behavior; humiliating, demeaning treatment of nurses, residents, and students; passive-aggressive behavior; passive disrespect; dismissive treatment of patients; and systemic disrespect.At one end of the spectrum, a single disruptive physician can poison the atmosphere of an entire unit. More common are everyday humiliations of nurses and physicians in training, as well as passive resistance to collaboration and change. Even more common are lesser degrees of disrespectful conduct toward patients that are taken for granted and not recognized by health workers as disrespectful.Disrespect is a threat to patient safety because it inhibits collegiality and cooperation essential to teamwork, cuts off communication, undermines morale, and inhibits compliance with and implementation of new practices. Nurses and students are particularly at risk, but disrespectful treatment is also devastating for patients. Disrespect underlies the tensions and dissatisfactions that diminish joy and fulfillment in work for all health care workers and contributes to turnover of highly qualified staff. Disrespectful behavior is rooted, in part, in characteristics of the individual, such as insecurity or aggressiveness, but it is also learned, tolerated, and reinforced in the hierarchical hospital culture. A major contributor to disrespectful behavior is the stressful health care environment, particularly the presence of "production pressure," such as the requirement to see a high volume of patients.

Perspective: a culture of respect, part 2: creating a culture of respect.

Creating a culture of respect is the essential first step in a health care organization's journey to becoming a safe, high-reliability organization that provides a supportive and nurturing environment and a workplace that enables staff to engage wholeheartedly in their work. A culture of respect requires that the institution develop effective methods for responding to episodes of disrespectful behavior while also initiating the cultural changes needed to prevent such episodes from occurring. Both responding to and preventing disrespect are major challenges for the organization's leader, who must create the preconditions for change, lead in establishing and enforcing policies, enable frontline worker engagement, and facilitate the creation of a safe learning environment.When disrespectful behavior occurs, it must be addressed consistently and transparently. Central to an effective response is a code of conduct that establishes unequivocally the expectation that everyone is entitled to be treated with courtesy, honesty, respect, and dignity. The code must be enforced fairly through a clear and explicit process and applied consistently regardless of rank or station.Creating a culture of respect requires action on many fronts: modeling respectful conduct; educating students, physicians, and nonphysicians on appropriate behavior; conducting performance evaluations to identify those in need of help; providing counseling and training when needed; and supporting frontline changes that increase the sense of fairness, transparency, collaboration, and individual responsibility.

Apology for errors: whose responsibility?

When things go wrong during a medical procedure, patients' expectations are fairly straightforward: They expect an explanation of what happened, an apology if an error was made, and assurance that something will be done to prevent it from happening to another patient. Patients have a right to full disclosure; it is also therapeutic in relieving their anxiety. But if they have been harmed by our mistake, they also need an apology to maintain trust. Apology conveys respect, mutual suffering, and responsibility. Meaningful apology requires that the patient's physician and the institution both take responsibility, show remorse, and make amends. As the patient's advocate, the physician must play the lead role. However, as custodian of the systems, the hospital has primary responsibility for the mishap, for preventing that error in the future, and for compensation. The responsibility for making all this happen rests with the CEO. The hospital must have policies and practices that ensure that every injured patient is treated the way we would want to be treated ourselves--openly, honestly, with compassion, and, when indicated, with an apology and compensation. To make that happen, hospitals need to greatly expand training of physicians and others, and develop support programs for patients and caregivers.

Commentary: how can we make diagnosis safer?.

Diagnostic errors are common and are a leading cause of patient dissatisfaction and malpractice suits. Because of its traditional heavy reliance on memory and lack of standardization, the diagnostic process is particularly error prone. A study by Zwaan and colleagues on diagnostic failures in treating dyspneic patients makes several important contributions: examining the process behind the diagnosis, seeking insights as to the reasons for the process failures by interviewing the treating physicians, and using the Delphi process with experts to map the optimal diagnostic process. There is considerable confusion about definitions in the field of diagnostic errors. The authors of this commentary use a Venn diagram to clarify distinctions and relationships between diagnosis processes errors, delayed diagnosis and misdiagnosis, and adverse outcomes. A key question is whether a much more rigorous process should be employed for diagnosis, specifically the routine use of algorithms or guidelines, and whether barriers to achieving it can be overcome. The authors propose an alternate simpler approach: six-part checklists for the top 20 or 30 clinical symptoms or problems. The elements of these checklists for minimizing diagnostic errors include essential data elements, don't-miss diagnoses, red-flag symptoms, potential drug causes, required referral(s), and follow-up instructions. These checklists could-and should-be developed by collaborative efforts of the main users, primary care physicians, and emergency physicians, working with specialist physicians on specific symptoms and diagnoses. Absent such professional commitment, progress in diagnostic accuracy is likely to be slow.

Defining and measuring integrated patient care: promoting the next frontier in health care delivery.

Integration of care is emerging as a central challenge of health care delivery, particularly for patients with multiple, complex chronic conditions. The authors argue that the concept of "integrated patient care" would benefit from further clarification regarding (a) the object of integration and (b) its essential components, particularly when constructing measures.To address these issues, the authors propose a definition of integrated patient care that distinguishes it from integrated delivery organizations, acknowledging that integrated organizational structures and processes may fail to produce integrated patient care. The definition emphasizes patients' central role as active participants in managing their own health by including patient centeredness as a key element of integrated patient care. Measures based on the proposed definition will enable empirical assessment of the potential relationships between the integration of organizations, the integration of patient care, and patient outcomes, providing valuable guidance to health systems reformers.

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 limitsand actively monitored. (ABSTRACT TRUNCATED)

Systematically seeking clinicians' insights to identify new safety measures for intensive care units and general surgery services.

Comprehensive measures to benchmark or track safety performance do not yet exist. The authors aimed to develop and validate a process to identify comprehensive, clinically meaningful sets of safety measures that would draw on the clinical experiences and perceptions of active practitioners. They pilot tested this process for safety measure development for 2 hospital departments (ie, intensive care units and general surgery services) by holding 7 brainstorming sessions with physicians and nurses in major academic and community teaching hospitals in Boston, Massachusetts, and Baltimore, Maryland. Participants identified lists of patient harms that they considered to be among the 20 most frequent and the 20 most severe in their respective units. The authors generated a master list of patient harms, which participants then ranked by both frequency and severity via E-mail voting. This process produced safety measures with inherent credibility with clinicians on the front lines of care.

Patient participation: current knowledge and applicability to patient safety.

Patient participation is increasingly recognized as a key component in the redesign of health care processes and is advocated as a means to improve patient safety. The concept has been successfully applied to various areas of patient care, such as decision making and the management of chronic diseases. We review the origins of patient participation, discuss the published evidence on its efficacy, and summarize the factors influencing its implementation. Patient-related factors, such as acceptance of the new patient role, lack of medical knowledge, lack of confidence, comorbidity, and various sociodemographic parameters, all affect willingness to participate in the health care process. Among health care workers, the acceptance and promotion of patient participation are influenced by other issues, including the desire to maintain control, lack of time, personal beliefs, type of illness, and training in patient-caregiver relationships. Social status, specialty, ethnic origin, and the stakes involved also influence patient and health care worker acceptance. The London Declaration, endorsed by the World Health Organization World Alliance for Patient Safety, calls for a greater role for patients to improve the safety of health care worldwide. Patient participation in hand hygiene promotion among staff to prevent health care-associated infection is discussed as an illustrative example. A conceptual model including key factors that influence participation and invite patients to contribute to error prevention is proposed. Further research is essential to establish key determinants for the success of patient participation in reducing medical errors and in improving patient safety.

Rating recommendations for consumers about patient safety: sense, common sense, or nonsense?

BACKGROUND: Although many organizations offer advice about the consumer's role in improving patient safety, little is known about these recommendations. METHODS: The Internet and medical literature were searched to identify patient safety recommendations for consumers. Recommendations were classified by type and tabulated by frequency. Nine investigators rated each recommendation for the quality of supporting empirical evidence, magnitude of benefit, and likely patient adherence. For a consumer perspective, 22 relatives of the investigators who were also mothers rated each recommendation. RESULTS: Twenty-six organizations identified 160 distinct recommendations; 115 (72%) addressed medication safety, 37 (23%) advised patients about preparation for hospitalization or surgery, and 18 (11%) offered general advice. Organizations most frequently advised patients to make a list of their medications (92% of organizations), to ask questions about their health and treatment (81%), to enlist an advocate (77%), and to learn about possible medication side effects (77%). Investigators assigned high scores to 11 of the 25 most frequently cited recommendations and to 4 of the 25 least common recommendations. There was little association between the frequency with which recommendations were promulgated and investigators' ratings (r = 0.27, p < .001). Investigators' scores correlated with those of the mothers (r = 0.71, p < .001). DISCUSSION: Contrary to expectation, there was little overlap among the 160 recommendations offered by the 26 organizations. Health care organizations offer many patient safety recommendations of limited value. These organizations should offer a concise and coherent set of recommendations on the basis of evidence, magnitude of benefit, and likely adherence.