Advancing Patient Safety: A Call for System Transformation

In 1999, the Institute of Medicine published a seminal report titled To Err is Human, which determined that tens of thousands of patient deaths annually result from preventable medical errors. The report sparked a national movement on patient safety, from support for research through the newly renamed Agency for Healthcare Research and Quality, to the adoption of delivery system innovations, including safety bundles and checklists, to investments in electronic health records. Yet despite some improvements over a quarter century, patient safety gaps persist in the United States, with health care–associated adverse events identified in one in four admissions as recently as 2018.

To this end, the President’s Council of Advisors on Science and Technology (PCAST) in 2023 issued a report calling for the President to adopt a national initiative to advance patient safety. The report’s recommendations are oriented around four pillars: establishing consistent federal leadership for patient safety, promoting the implementation of evidence-based practices for harm reduction and risk mitigation, focusing on addressing disparities in safety events, and increasing investments in patient safety research with particular emphasis on new information technologies, including artificial intelligence.

These recommendations are founded on the premise that there is a need for coordinated federal leadership to produce transformative improvements in patient safety. While many federal agencies and Departments have pushed patient safety initiatives (e.g., Partnership for Patients, Hospital Value-Based Purchasing), a unified national approach can achieve true system transformation with substantially better performance. Consequently, PCAST has recommended establishing a Patient Safety Coordinator within the White House with a mandate for interagency coordination and an independent National Patient Safety Team designed as a public-private partnership to drive system-wide improvements, to fill the national leadership vacuum and, ultimately, eliminate the risk of these preventable tragedies.

Likewise, despite efforts to improve transparency—including the creation of Patient Safety Organizations, payment reforms related to hospital-acquired conditions, and health care data digitization—there remains uncertainty about the incidence, causes, and impact of adverse events in health care facilities across the country. To address this issue, PCAST recommended better measures and annual public reporting of high-priority harms—including so-called “never events”—as critical to securing the public’s trust and drive accountability for stakeholders.

Despite PCAST’s detailed assessment and proposals, there are notable barriers to translating its recommendations into reality. The report’s success depends importantly on successful implementation. What then, can policymakers and practitioners do to ensure that PCAST’s recommendations can serve as a launching pad for finally solving the problem of preventable iatrogenic harm that is endemic to our health system?

First, in addition to federal coordination, cross-sector partnerships are needed to elevate patient safety into the national consciousness as a cause worthy of sustained investment and action. Health care delivery needs to move into an era where systems are engineered to perform at higher levels and eliminate patient safety risks. Such advances were achieved in aviation, partly by moving from a focus on an individual’s errors to a system-based response to safety. To this end, PCAST calls for establishing a National Patient Safety Team to act as an independent, public-private partnership that makes regular, publicly available evaluations of patient safety. Such an organization has precedent in other industries. For example, the US government established the Commercial Aviation Safety Team (CAST) in response to a 1997 White House Commission. CAST helped elevate aviation safety by implementing a data analysis team, leveraging international partnerships, and including stakeholders from the industry, such as corporate leaders and frontline employees like pilots and air traffic controllers. As a result, CAST not only met but exceeded the Commission’s stated goal of reducing aviation fatality by 80% over ten years. A similar model for health care can incorporate leaders from care delivery organizations (hospitals, clinics, nursing homes), payers, technology companies, providers, and patients to build consensus around a bold national target for reducing adverse event rates.

Second, achieving radically better outcomes requires using different tools and ways of thinking compared with the first twenty-five years. Historically, patient safety initiatives have focused on changes in process, from checklists to communication protocols to staffing requirements. These efforts have yielded benefits in select use cases (e.g., central line-associated bloodstream infections) but have not affected the diverse causes of adverse events. Of particular concern is diagnostic error, which is a leading cause of patient safety events estimated to cost American medicine over $100 billion each year. Today, the art of diagnosis is at an inflection point with the advent of potentially transformative technologies, including artificial intelligence and large language models, some of which are already being incorporated into clinical decision-support tools and used in clinical practice. However, such tools have been subjected to limited oversight to date, carry risks of perpetuating structural biases, and may pose safety concerns in their own right. Consider the case of the Epic Sepsis Prediction Model, a clinical algorithm developed by the nation’s dominant electronic health record vendor and powered by artificial intelligence to aid clinicians in identifying hospitalized patients at risk of developing sepsis. The model was widely adopted despite limited transparency about its design and development, and an independent evaluation later found its accuracy to be substantially lower than previously advertised. While Epic later updated its algorithm, the episode underscores the need for a framework to promote model transparency and performance evaluation as more of these technologies enter clinical practice. To this end, PCAST calls on the federal government to harness revolutionary advances in information technologies, including creating an interagency “AI for Patient Safety” program. While technology alone is not a panacea, it is imperative for health care to address the risks and benefits head-on through sustained research, innovation, and monitoring.

Lastly, leading the call for safety requires investing in the people who make health care work. The PCAST report echoes To Err in affirming that dangerous and preventable adverse events occur despite the passion and deep-seated commitment of all allied health professionals to patient care. At the same time, long-brewing discontent in the health care workforce—from understaffing and attrition, to burnout and moral injury—risks compromising the sacred relationship between providers and patients critical to safe and effective patient care. Transforming patient safety is therefore not possible without equal attention to the burnout experienced by providers. The PCAST report explicitly elevates the importance of improving the conditions of health care workers as a precondition for advancing patient safety, with particular emphasis on advancing a “just culture.” Achieving this aspiration requires overdue investments and protections for health care workers and engaging providers as equal partners by channeling their intrinsic motivations to do good.

Patient safety is more than just a priority for advancing population health—it also reflects medicine’s fundamental covenant to “first, do no harm.” Amid all the challenges facing American health care today—from concerns about system capacity to political polarization to insidious financial influence—the most basic challenge is trust. Patients should be able to trust that health care heals, rather than harms. And patients should be able to trust that while mistakes might be inevitable, efforts to continually improve to minimize them will be inexorable. The PCAST report provides a vision for how we can renew the nation’s commitment to patient safety. Now it’s up to us all to partner to make it a reality.