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Transforming concepts in patient safety: a progress report
  1. Tejal K Gandhi1,
  2. Gary S Kaplan2,
  3. Lucian Leape3,
  4. Donald M Berwick1,
  5. Susan Edgman-Levitan4,
  6. Amy Edmondson5,
  7. Gregg S Meyer6,
  8. David Michaels7,
  9. Julianne M Morath8,
  10. Charles Vincent9,
  11. Robert Wachter10
  1. 1 Institute for Healthcare Improvement, Boston, MA, USA
  2. 2 Virginia Mason Health System, Seattle, Washington, USA
  3. 3 Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA
  4. 4 John D Stoeckle Center for Primary Care Innovation, Massachusetts General Hospital, Boston, MA, USA
  5. 5 Harvard Business School, Harvard University, Boston, Massachusetts, USA
  6. 6 Partners Healthcare, Boston, Massachusetts, USA
  7. 7 George Washington University Milken Institute of Public Health, Washington, District of Columbia, USA
  8. 8 California Hospital Quality Institute, Sacramento, California, USA
  9. 9 Experimental Psychology, University of Oxford, London, Oxfordshire, UK
  10. 10 Medicine, University of California San Francisco, San Francisco, California, USA
  1. Correspondence to Dr Tejal K Gandhi, , Institute for Healthcare Improvement, Boston, MA 02109, USA; tgandhi{at}


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.

  • patient safety
  • medical education
  • safety culture
  • leadership

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The National Patient Safety Foundation (NPSF) created the Lucian Leape Institute (LLI) in 2007 to provide a strategic vision for improving patient safety. Composed of national leaders with a common interest and expertise in safety, the LLI was charged with identifying new approaches to improving patient safety; inspiring innovation necessary to expedite the work; creating significant, sustainable improvements in culture, process and outcomes and encouraging key stakeholders to assume significant roles in advancing patient safety.

At the time, the major challenge of improving patient safety was not a technical issue of devising new systems, but a cultural issue of creating an environment in which such systems could take root. The founding members set an aspirational vision for transformation in a paper that identified five major concepts for system-level action: (1) medical education must be redesigned to prepare new physicians and other health professionals to function in these new cultures; (2) care must be delivered by multidisciplinary teams working in integrated care platforms; (3) healthcare workers need to work in safe environments and find joy and meaning in their work; (4) patients must become full partners in all aspects of designing and delivering healthcare and (5) transparency must be a practiced value in everything we do.1

The LLI recognised that articulating these transforming concepts was not enough. Healthcare leaders needed to be persuaded to implement them. In 2009, the LLI began to convene expert roundtables to address each concept and engage stakeholders. Results were disseminated in reports published between 2010 and 2015, and the major recommendations are summarised in this paper. While multiple challenges remain, encouraging progress has emerged in each of these areas.

Medical education reform

Equipping doctors to improve the safety of healthcare systems is the task of medical education, not just in medical schools, but across the continuum of training and practice. Unmet Needs: Teaching Physicians to Provide Safe Patient Care 2 examines the need for education reform, describes the changes required and makes specific recommendations directed at medical schools, teaching hospitals and accrediting bodies (table 1). While it is essential for all members of the team to develop these skills, this report focused on physicians as the starting point.

Table 1

Key recommendations from Unmet Needs: Teaching Physicians to Provide Safe Patient Care


In recent years, medical school curricula have increasingly included patient safety and safety science, and these concepts have also become more common in education for other clinicians and frontline staff. For example, the American Medical Association’s Accelerating Change in Medical Education Consortium brought medical schools together to innovate, develop curricula and share best practices, including those addressing quality and safety. The Accreditation Council for Graduate Medical Education Clinical Learning Environment Review (ACGME CLER) programme requires medical resident participation in quality and safety learning. Recently, the Association of American Medical Colleges initiated a programme to create a shared understanding of Quality Improvement and Patient Safety competencies across the full continuum from medical school to continuing practice.

Other clinical disciplines, particularly nursing, have often pioneered educational pathways, and a concerted effort is underway to emphasise the importance of interprofessional teams. The Quality and Safety Education for Nurses programme has focused on enhancing education around safety science in nursing schools for more than a decade. More recently, the National Collaborative for Improving the Clinical Learning Environment highlighted the ‘patient safety gap’ in the education and training of all clinicians and provided clear recommendations for improvement.3

To assist healthcare students and professionals in building core skills in improvement, safety and leadership, the Institute for Healthcare Improvement (IHI) developed a web-based interactive educational programme called the Open School. More than 650 000 learners have enrolled in the Open School since it opened its virtual doors in 2008. To address the need for training in postgraduate medical education, in 2012 the NPSF created a course in patient safety and safety science that more than 7000 learners of diverse disciplines have used. Several universities have developed graduate education and fellowships in quality and safety, and clinicians, risk managers, pharmacists, executives and others have pursued these as well as certificate programmes and professional certification in patient safety.4

Remaining challenges

Still, opportunity lies ahead for greater consistency in how health professionals learn about patient safety. A 2016 report from ACGME CLER reveals gaps in areas such as feedback on safety reporting and experiential learning, lack of awareness of the range of patient safety issues and shortage of opportunities for interprofessional system-based improvement efforts.5 Contributing to this learning gap is a shortage of academic faculty with safety and quality improvement expertise.6

Continuing education requirements for attending physicians are highly variable. While some medical specialties require continuing education in patient safety, the American Board of Internal Medicine recently removed it as a requirement from Maintenance of Certification.7 Healthcare organisations would benefit from encouraging study of safety science by all team members, including board members, and operationalising ways to achieve continuous learning as safety science expands.

As these and other activities gain momentum, the core agenda remains consistent, clear and urgent: to mainstream the preparation of health professionals’ awareness, skills, commitment and practical training about the scientific pursuit of safer care. Embracing the science of safety in medical education is crucial to the future health and well-being of patients, families and communities.

Care integration

Order from Chaos: Accelerating Care Integration 8 concludes that poor care integration is linked to adverse events, and improvements in this area should be among the top priorities for achieving a more consistently safe, effective and efficient healthcare system. The report noted the need for establishing a shared understanding among public and private stakeholders, including the media and consumer advocacy groups, regarding the link between care integration and patient safety. Best practices for improving care integration need to be developed and widely disseminated (table 2).

Table 2

Key recommendations from Order from Chaos: Accelerating Care Integration


With an increased call for improved coordination of care and focus on patient safety across the care continuum, methods for improving handoffs and communication among teams, providers and patients are gaining traction.9 Today the focus on population health and market-specific shifts in payment models serve as incentives for greater care integration and coordination.

Progress has been made to develop systems and structures to encourage and incentivise care integration. Accountable Care Organisations (ACOs) have brought together groups of health providers to incentivise better quality care at a lower cost. Likewise, the development of the patient-centred medical home aims to reorganise and reinvigorate primary care, and early evidence shows promise in achieving lower costs, improved patient experience and better care quality.10

Other encouraging examples of improved care integration include Project Re-Engineered Discharge (Project RED), the Patient-Centered Outcomes Research Institute (PCORI)-funded Project ACHIEVE (Achieving Patient-Centered Care and Optimized Health In Care Transitions by Evaluating the Value of Evidence) and the Johns Hopkins School of Nursing–led Community Aging in Place: Advancing Better Living for Elders (CAPABLE). For example, Project RED developed strategies to improve the hospital discharge process to promote patient safety and has been proven to reduce rehospitalisations and yield high rates of patient satisfaction.11

Finally, the increase in employed physicians and continued refinement of the electronic health record have accelerated care integration. Improving interoperability of health information technology has been a major initiative at the federal level to improve information flow across the entire care continuum.12

Remaining challenges

Despite incremental improvement, coordination and integration of care remains difficult, particularly for patients with multiple chronic conditions.13 Even with a national push towards more integrated care models (perhaps most focused on the development of ACOs), so far results towards safer, more coordinated care have been mixed. Furthermore, care integration issues are compounded for older adults. One study found that the average Medicare beneficiary spent about 17 days in contact with the healthcare system through an average of 3.4 different clinicians. Only 55% of these individuals coordinated their care principally with a single primary care physician.14

Structural changes alone will not ensure optimal care integration. Strong clinician leadership and patient engagement will be required to further improve care coordination. Involving patients and families in the codesign of care, especially around coordination and care delivered in the home, will help identify unmet needs and educational deficits.

Care integration remains perhaps the most challenging of the transforming concepts because of the fragmentation of the US healthcare system. When Americans are asked to reflect on the integration of care from their own experiences, some refer to the term ‘healthcare system’ as an oxymoron.15 Individuals responsible for coordinating care and helping patients navigate the care system include primary care physicians, specialists, nurses, pharmacists, social workers and care managers as well as health plan and delivery system personnel. As care becomes more complex and shared among more providers, it is essential to improve both processes (eg, teamwork, communication and patient engagement) and technologies (eg, EHRs) for patients and providers.

Joy and meaning in work and workforce safety

The mission-driven work of healthcare professionals, who serve others during their most vulnerable moments, should rightly bring joy and meaning to the lives of our workforce. Through the Eyes of the Workforce: Creating Joy, Meaning, and Safer Health Care 16 looks at how to improve workforce safety and joy in work.

The risk of physical harm to healthcare workers is much higher than for workers in other industries and includes injury resulting from preventable environmental risks such as falls, musculoskeletal injuries, needle sticks and workplace violence.17 Emotional harm is also pervasive, with regular reports of disrespect, blaming and a punitive environment. Production pressures cause caregiver fatigue, and many are exposed to team-preventive behaviour, such as criticism, bullying and even physical harm. The damaging effects of disrespectful cultures in healthcare18 and the extent and effects of burnout are being increasingly recognised.19 However, action to remedy these effects remains slow, and the report made the recommendations outlined in table 3.

Table 3

Key recommendations from Through the Eyes of the Workforce: Creating Joy, Meaning, and Safer Health Care


Multiple initiatives are underway to increase awareness of the importance of joy and meaning in work and workforce safety. The National Academy of Medicine and several healthcare professional groups and insurers, such as the American Association of Critical-Care Nurses, the American Nurses Association (ANA Enterprise), the American Medical Association and the Harvard Risk Management Foundation are addressing the issue of resilience and burnout.20 IHI has developed a framework for increasing joy in work that recommends domains such as reward and recognition, choice and autonomy, camaraderie and teamwork and physical and psychological safety.21 Some have observed that the widely accepted goals of the Triple Aim22 should be expanded to include workforce safety and joy and meaning in work—the Quadruple Aim.23 24

Regarding healthcare workforce physical safety, noteworthy efforts are proceeding. With the support of the Centers for Medicare & Medicaid Services (CMS), the US Occupational Safety and Health Administration recently launched an initiative to encourage hospitals and healthcare facilities to implement safety and health management systems to prevent injuries among their workforce and patients.17 Similarly, The Joint Commission has provided detailed reports and tools for improving workforce safety and reducing workplace violence.25

Remaining challenges

Despite these efforts, according to one recent study, more than half of US physicians suffer from burnout.26 Among critical care nurses, 25%–33% have symptoms of severe burnout syndrome.27 Physicians do have higher rates of burnout than the general public and they also suffer higher rates of depression and suicide.28 The effects of psychological, emotional and physical harm to the workforce surface in the form of litigation, lost work hours, employee turnover and inability to attract newcomers to caring professions. With healthcare reform, pay-for-performance, the introduction of electronic health records and other innovations, healthcare workers spend less time directly caring for patients—further draining energy, meaning and joy.

Compounding the issue, a recent survey found that only 23% of hospital boards review workplace safety dashboards.29 Our healthcare workforce is endangered, and without a healthy, engaged and supported workforce, safer patient care will remain elusive.

Patient and family engagement

Despite evidence that partnering with patients and families yields improved outcomes and patient experience as well as a safer and more productive work environment for healthcare professionals, organisations still struggle with achieving meaningful, lasting patient and family engagement. Safety Is Personal: Partnering with Patients and Families for the Safest Care 30 looks at barriers including fragmentation within the healthcare system, the persistence of a paternalistic professional culture, poor process design and infrequent involvement of patients and families in codesign efforts. It notes the lack of training in key communication strategies such as eliciting what matters most to patients for shared decision making, plain language communication and disclosure and apology (table 4).

Table 4

Key recommendations from Safety Is Personal: Partnering with Patients and Families for the Safest Care


With the increasing use of decision aids, patient portals, OpenNotes, care engagement plans and the spread of Patient and Family Advisory Councils (PFACs), healthcare leaders and clinicians are beginning to understand the power of engaging patients and families as integral partners. The OpenNotes programme has demonstrated that patients can contribute to preventing or mitigating errors.31 32 Patient experience data are being used more widely and effectively. Mandates from CMS, the National Committee for Quality Assurance and other payers for use and improvement of Consumer Assessment of Healthcare Providers and Systems patient experience survey data are linked to improved performance and outcomes. Healthcare systems, hospitals and ambulatory practices are also beginning to incorporate patient preferences into care design by including patients and their families as active participants in codesign and research studies funded by the PCORI. The internationally observed ‘What Matters to You? Day’ aims to encourage meaningful conversations between patients, families and providers.

Patient and family perspectives are valuable in many arenas, from design of the physical environment and care coordination plans to reporting safety concerns and participation in root cause analyses. Patient engagement should be authentic and take place across the continuum of care from the bedside to the boardroom to national policy committees. The newly established Patient Experience Policy Forum affiliated with the Beryl Institute is advocating for patient and family partnerships in codesign and policy-making nationally.

Remaining challenges

While some exemplary organisations are fully engaging patients in the care process, ample opportunities for improvement remain. Many organisations lack effective PFACs and have not devoted resources to train staff in shared decision-making practices or to offer evidence-based decision aids. The current fee-for-service payment system does not encourage clinicians to spend the time needed to communicate with patients nor to elicit their preferences. Many organisations still lack process improvement skills to support integrating better communication into clinical workflows. As care shifts from inpatient to ambulatory and home care settings, patients and families are becoming more responsible for delivering their own care. However, they may not be well equipped to manage complicated medication regimens, activities of daily living, medical devices or infection control procedures.33

Overwhelming evidence indicates that collecting patient feedback and including patients as equal partners in their care support improvement in both patient experience of care and clinical outcomes.34 Opportunities remain to partner with patients, families and communities to accelerate improvement in education, patient satisfaction and quality of care.


Shining a Light: Safer Health Care Through Transparency 35 defines four domains of transparency: between clinicians and patients, among clinicians, among healthcare organisations and public reporting. The report holds that transparency is ethically correct and leads to improved outcomes, fewer errors, more satisfied patients and lower costs. The report made recommendations for improving transparency in all four domains (table 5).

Table 5

Key recommendations from Shining a Light: Safer Health Care Through Transparency


Today, the call for greater transparency in healthcare is growing louder. Consumers have begun to post reviews of their physicians, care teams and healthcare organisations on online review platforms. Moreover, some healthcare systems are now collecting and posting information from patient experience surveys at the service or physician level. Recently, several health systems have begun to provide forums for free-response comments online, often with positive results.36

The 2005 Patient Safety and Quality Improvement Act and the rise of patient safety organisations have facilitated increased transparency among clinicians and healthcare organisations. Additionally, collaboratives like Solutions for Patient Safety, a network of more than 130 children’s hospitals working together to eliminate serious harm, have shown compelling evidence that sharing data, successes and failures can markedly accelerate learning and improvement.37

Healthcare is also seeing greater transparency between patients and clinicians in the aftermath of adverse events. A growing number of Communication and Resolution Programmes have been established, fuelled by growing evidence that prompt disclosure, honesty and apology following patient injury can decrease medical malpractice liability and improve the satisfaction of all parties.38 Toolkits are now available to promote such programmes.39

Remaining challenges

Many challenges to achieving full transparency remain.40 A recent survey found that less than 40% of quality and safety leaders rated their board’s understanding of disclosure and apology as ‘high’, and even fewer felt their boards had a comprehensive understanding of safety concepts related to transparency about error and harm.29 Transparency within organisations and between providers requires creating an environment of trust as well as improving technology and processes to ensure they are efficient, effective and promote regular open and honest communication and data sharing.

Transparency with the public is equally challenging. Hospital and clinician concerns about litigation; reputational costs and the accuracy, interpretability and comprehensiveness of safety metrics need to be addressed. Additionally, national rating systems and websites, including Leapfrog and US News & World Report, share few common scores and often generate more confusion than clarity. For example, as of 2015, no hospital was rated as a high performer by all four major national US rating systems.41 In the future, data must be understandable and actionable for both patients and provider organisations.

As more organisations publicly share their quality, safety and patient experience data, transparency will be increasingly demanded by all stakeholders. To benefit patients as well as care providers, organisations will need to prepare their boards, clinicians and staff for a more transparent healthcare system. Transparency at these levels will eventually facilitate decision making about where to receive care and where to work, but a long road lies ahead to make this comparable and uniform across all health entities.

Next steps

Reports about the five transforming concepts provide guidance healthcare organisations need to achieve safe care. While treated separately in the reports, the transforming concepts are interrelated. For example, healthcare professionals experiencing burnout are more prone to commit diagnostic and patient safety errors and less likely to engage patients and colleagues.42–44

Medical education reform, joy and meaning in work, care integration and patient and family engagement are also interrelated. For patients with chronic illness, effective intervention often relies on integrated care received across the continuum, where patient engagement is key. Physicians and other providers with training and experience in communication strategies that support teamwork and shared decision making are better prepared to provide coordinated, cross-continuum care for these complex patients.

Each report calls for leadership commitment and recognition of safety as an integral component of operational culture to enable lasting improvement in both patient and workforce safety.

The LLI has already begun to partner with professional organisations to expand and facilitate their safety programmes, focusing on the importance of leadership, effective and engaged boards and a strong safety culture.45 In addition, plans are underway to improve how organisations measure the safety of their patients and workforce and the reliability of their system. Healthcare needs more and better ways to identify and measure risks and hazards in real time, or proactively, to potentially intervene before an adverse event occurs.

Further research around each of the transforming concepts is warranted. With medical education reform, for example, ACGME has sought to monitor and measure the effectiveness of residency training programmes. For care integration, better research is needed around the effectiveness of new models of care. From confidential sharing of data among organisations to the involvement of patients in root cause analyses, each approach to increased transparency should undergo rigorous research to better understand its benefits and harms. While more leaders, policy makers and regulators are embracing these concepts, much remains to be learnt about how best to engage all leaders, which practices are most effective and how best to implement them.

Finally, while this assessment has focused primarily on the US healthcare system, the LLI looks forward to the opportunity to reflect on the five transforming concepts in systems worldwide, sharing perspectives, best practices and greater opportunity for learning and improvement.


The five transforming concepts were meant to highlight important gaps in safety and to serve as new directions to accelerate progress in patient safety. These concepts are overlapping and synergistic, with common themes including the need for leaders who can build a safety culture to create the right environment to advance these concepts, for clear and meaningful measurement, and for research to advance understanding and improvement capability in these areas. It is essential that national professional organisations, foundations and the government support these efforts to change how clinicians are educated, create safe learning environments, integrate care across the continuum, create joy and meaning and safety for the healthcare workforce, engage patients and families at all levels of care and promote transparency. These strategies are as critical now as when first described and are key to advancing the LLI’s mission to have a world where patients and those who care for them are free from harm.


The authors wish to acknowledge Erin Hartman, MS; Joellen Huebner, BA; Patricia McTiernan, MS; Jane Roessner, PhD; and Elma Sanders, PhD, for assistance in drafting and editing portions of the text and Anita Spielman, BA, CPPS, for research assistance.



  • Funding This study was funded by Medtronic (grant number #6981).

  • Competing interests None declared.

  • Patient consent Not required.

  • Provenance and peer review Not commissioned; internally peer reviewed.