Sarah Mossburg: Hello and welcome, Patricia. Can you tell us about yourself and your role?

Patricia McGaffigan: I am a nurse with a diverse background that includes clinical practice in pediatric critical care and teaching. I spent many years with both startups and established medical device companies that were heavily focused on safety monitoring and surveillance technologies in roles that include education, business development, marketing, and leading strategic relationships with healthcare organizations and associations to advance the safe care of patients.

I joined the National Patient Safety Foundation in 2012 and served as interim president, chief operating officer, and senior vice president of programs prior to our 2017 merger with the Institute for Healthcare Improvement (IHI). I’m one of IHI’s vice presidents for patient and workforce safety and am president of the Certification Board for Professionals and Patient Safety. I am co-chair of the National Steering Committee for Patient Safety and participate in several task forces and committees focused on the safety and well-being of patients and the workforce.

Sarah Mossburg: IHI plays a really big role in patient safety and sharing best practices. Can you share more about the background of the organization and its mission?

Patricia McGaffigan: The nonprofit IHI was established over 30 years ago. The common denominator across our global work is the application of improvement science to improve health and healthcare. Our focus is on raising awareness of safety and quality and accelerating the learning and the systematic improvement of care, innovating around often intractable challenges and new opportunities, and mobilizing communities that include health systems, regions, and nations to reduce harm and improve the health of individuals and populations. We accomplish this work through a global network of staff, faculty, fellows, strategic partnerships, and learning communities.

Sarah Mossburg: With IHI focused on better health outcomes and reducing harm, we would love to get your thoughts on the shifts in patient safety since the public health emergency began in March 2020. Can you tell us what trends you have seen in patient safety since the start of the COVID-19 pandemic?

Patricia McGaffigan: We have seen a range of setbacks in patient and workforce safety, some of which we feared might be realized at the outset of the pandemic. In the category of healthcare-acquired conditions, where we had made progress prior to the pandemic, in the United States, we have since experienced higher rates of preventable infections, as well as increases in pressure ulcers and falls. These disappointing setbacks suggest critical vulnerabilities, and we have important opportunities to recover and rebuild resilience.

As healthcare systems faced overloads of very sick patients with COVID-19, routine preventive care,  management of acute and chronic conditions, continuity of care, and even basic access to timely diagnosis and care were deeply disrupted. Impacts to physical and mental health have affected both those whom we serve and those who work in healthcare. The exclusion of care partners, like patients’ family members, who are not the same as casual visitors, mattered deeply because they are integral to the safety and supportive care network of patients. We saw the work of patient and family advisory groups grind to a halt in many organizations, whereas others realized that it was more important than ever to keep the voice and wisdom of patients front and center in the adaptive work that was necessary. A spotlight on inequities has become increasingly documented and created new priorities for healthcare.

The trends on the workforce side have been well documented. Many trends are pre-pandemic realities that have worsened during the pandemic, such as staffing shortages, workplace violence, burnout, anxiety, depression, and suicide. We’ve seen setbacks in safety culture scores, engagement, and feeling valued, as well as  attrition from jobs and healthcare professions, and a shift to a workforce that is increasingly contingent, meaning an increased composition of travel, per diem, and gig workers.

We’ve seen sizeable shifts to alternative models of care and locations of care delivery, with the use of telemedicine, virtual services to connect patients to their care teams and families, and increased care of acute and chronically ill patients in nonhospital settings including the home. Concomitant with the pandemic are other realities such as increased consolidation across healthcare, the emergence of disruptive entries into the health care arena such as retail and technology giants, and uptake of digital technologies and artificial intelligence.

One trend that I hope we’ll sustain is the shift to rapid communities of learning across local, regional, national, and international settings. For example, IHI partnered on weekly virtual learning hours to convey time-sensitive learnings and support real-time adaptation and problem solving in areas such as nursing homes and supporting the workforce. 

Sarah Mossburg: Do you think any of these trends had a larger impact on patient safety compared with the others?

Patricia McGaffigan: While we could debate whether any one of these trends have had a larger impact on safety than others, I believe that for better or worse, it’s the “perfect storm” combination. While any one of these trends can impact safety, the combination of these trends contributes to both vulnerabilities and to pathways for improving safety and system resilience, since safety is a system property. It’s a “perfect storm” combination of attention to safety that is necessary, with constancy of purpose. This means that attention to whole system safety and quality is our daily compass and daily work, where we’re creating the conditions for a thriving workforce, where patient and family engagement is both full and meaningful, and where we are constantly sharing and transparent in our learnings about preventing and controlling risk. We can’t simply legislate our way into putting more colleagues at the bedside as the determinant that care is safe, for example. It’s about ensuring that the work environment, cultures of safety and equity, safety systems, competencies, and balance of human and system resources are intentionally designed to enable reliable, person-centered, and compassionate care and healing regardless of where care is received and delivered. 

Sarah Mossburg: Were there organizations or areas that experienced improvements in safety during the pandemic?

Patricia McGaffigan: Yes, some organizations seemed to do better during the pandemic, meaning they were able to sustain their gains, or in some cases see continuous progress. These organizations entered the pandemic with a wholesale constancy of purpose around safety, in which attention to whole system safety and quality was their daily compass and daily work, as was creating the conditions for a thriving workforce, meaningful patient and family engagement, and constant learning about ways to reduce and control for risk.  

Some of the characteristics of these organizations send important signals for us to emulate.  Leaders, for example, were physically present and accessible, rounding on units and actively visible in interactions and learning from staff. They led with  humility and generosity, and modeled real-time learning, support, and problem-solving. This is emblematic of what I would hope our collaboration and daily work in safety looks like every day, “crisis” or not. Another example is how they prioritized the safety and wellbeing of the workforce, and valued human assets beyond the bricks, mortar, and technologies. And they were responsive to identifying inequities, reaching deeply into communities, and prioritizing action to address vulnerable populations.

Sarah Mossburg: With the public health emergency ending in May 2023, many healthcare organizations are thinking about how to regain the ground that they lost during the pandemic. What are your thoughts on how organizations can do so?

Patricia McGaffigan: The pandemic revealed the loss of important progress in safety and the  work we must do to move from  fragility to resiliency in safety. Evidence continues to accumulate from both pre-pandemic and throughout the pandemic. For example, a recent study using 2018 data showed that preventable harms were very common in 11 hospitals in the State of Massachusetts, with  one out of every four patients experiencing an adverse event in the course of their admission. A safety strategy this is focused on individual performance alone is both insufficient and unrealistic as the path toward safety. Regaining ground requires not only acceptance of this reality but also actions that balance the intentional design of systems for safety with accountability of all levels of healthcare.  

The loss of trust of both the communities we serve and the healthcare workforce is especially important for healthcare organizations to address. Regaining ground absolutely requires a non-negotiable commitment from healthcare leaders, governance bodies, practice owners, and others to demonstrate that above all else, care is safe, reliable, and equitable, not only in the moment, but as  our unwavering purpose and not a variable priority.

This reorientation requires our collective acknowledgment that we can no longer address safety in fits and starts, as we have for decades, and that we are never truly safe because safety is a product of where we are and every given moment. Regaining lost ground is going to require us to do something radically different from what we have been doing in the past.

It’s time for us to double down on investing resources to understand and improve in the settings where most care is provided, including the home, ambulatory settings, and the community, and to address safety from the lens and journey of the overall patient experience, and not as slices of individual patient encounters across disparate and disconnected points of care. It’s time for us expand our definition of harm beyond harms that are physical to those that are  psychological, sociobehavioral, and financial.  And it’s time to move beyond lagging indicators of safety to upstream measures and attention to how we identify and mitigate risks.

Sarah Mossburg: One way that we measure safety is through performance measures. We have been talking about trends in performance measures. What are your thoughts on other ways to measure patient safety and how we can understand if patient safety is improving other than through performance measures?

Patricia McGaffigan: Many of our performance measures are associated with measuring and reporting specific harms, such as an infection, falls with injury, or mortality. This work is important, but keep in mind that these are lagging indicators, and more importantly that a person who trusted us to provide safe care has experienced harm. While decreases in harms are certainly our goal, a decrease in downstream measures of harm can provide a false sense of security that we are safe. When we do experience setbacks in performance measures of harm, we often tend to layer and repeat improvement projects to get performance back on course. Often, these projects emphasize reeducation and reinforcement of policies and procedures to improve human compliance as our route toward safety.

Since safety is a dynamic reality, reorienting focus from performance measures of harm to measures that reflect risk prevention and control is a vital part of what is going to be needed to get us to safer care. Let’s compare what this looks like for a common source of harm, medication errors. After an error has occurred, we expend lots of time and resources doing event investigations to identify what went wrong, and we create response plans that place the humans in our workforce in perpetual cycles of ineffective and often frustrating corrective actions with less attention on stronger actions that improve the systems in which humans work. A different approach would be to recognize that humans are fallible and that risks are prevalent in the highly complex sociotechnical system that is healthcare. We anticipate those risks and design systems to control those risks in the first place, in conjunction with the persons who are doing the work.

Even when we implement a safety solution that we think will prevent risks from becoming reality, we must constantly be proactive in pressure testing our assumptions. For example, we have alerting systems to notify us of risks in the dispensing and preparation of medications that may lead to a sense of security when implemented. Yet if we haven’t anticipated the reality that the system may experience downtime, there’s a massive vulnerability when systems are not functional. If systems appear to be functional but our workforce is overriding alerts, and we either ignore this reality or blame our workforce for noncompliance without understanding and addressing reasons why overrides may be happening, we send very mixed signals that suggest that drift into harm is acceptable versus taking action to avoid drift into harm as a result of latent risks in our system, many of which are operational. 

Sarah Mossburg: How has IHI’s work or focus changed during the public health emergency to refocus on patient safety?

Patricia McGaffigan: One thing that I’m especially proud of is IHI’s agility and ability to pivot, innovate, and spread improvements during both conventional and crisis conditions. The pandemic was a great example of our organizational agility and determination to lead, convene, identify, and conduct small tests of change and to ramp up communities of learning.

One of our first actions was to initiate virtual sessions and communities to support rapid, global learning. We had weekly calls and huddles with colleagues who shared their experiences and lessons learned. With the support of the John A. Hartford Foundation, we set up a rapid response network specific to nursing homes to offer brief calls, 20 min calls per week over many months, on a variety of COVID-related topics. This was a valuable and efficient approach to supporting a global workforce that had very high needs for real-time information to support adaptation.  

We partnered with AHRQ and Project ECHO in the Nursing Home COVID-19 Action Network to create and provide free training and support to nursing homes across the United States to increase the implementation of evidence-based infection prevention and safety practices to protect their residents and staff from COVID-19. More than 9,000 nursing homes in this country participated in the virtual community where they received mentoring, technical assistance, and critical peer support.

Like many organizations, IHI has incorporated a range of virtual, hybrid, and in-person approaches to advance our work across our focus areas of safety and effectiveness, equity, and health system resilience. Some examples include the creation of a National Action Plan for patient safety, our Rise to Health Equity Coalition, population-specific initiatives such as Age-Friendly Health Systems and our global work in maternal-infant health, programs to support professional development for well-being leaders and support joy and well-being in work, support competencies in safety, and the integration of new areas of focus, such as diagnostic excellence into our conferences. 

Sarah Mossburg: IHI released the National Action Plan to Advance Patient Safety in collaboration with AHRQ. Can you tell us a little bit more about the National Action Plan?

Patricia McGaffigan: Safer Together: A National Action Plan to Advance Patient Safety was established through the vision and commitment of the IHI Board of Directors shortly after the merger between IHI and the National Patient Safety Foundation. Our board is incredibly committed to eliminating harm and advancing safety. We have known for decades that we needed a national and coordinated effort to establish a national plan for safety. The board funded the convening of a National Steering Committee for Patient Safety in 2018, and we engaged 27 organizations and associations from around the country, including six federal agencies, one of which is the Agency for Healthcare Research and Quality, and patients and family partners, to agree that we would work together on the creation of a National Action Plan.

We initially planned to release the National Action Plan in May 2020. Given the pandemic, we rapidly evaluated and confirmed that it was even more relevant and appropriate. With recognition that the pandemic was not going anywhere soon, we released the National Action Plan on September 17, 2020, which is World Patient Safety Day. As more data accumulated that documented setbacks in patient and workforce safety amid an increasingly stressed healthcare systems, in May 2022 the NSC released the Declaration to Advance Patient Safety. It was a call to health system leaders across the entire continuum of care to review the National Action Plan, use the Self-Assessment Tool to assess their organization’s current state, and implement a plan of action to address key opportunities to fortify their safety ecosystem, which is essential for ensuring durability of safety.

Sarah Mossburg: One of the concepts in the National Action Plan is total systems safety. Could you briefly explain that to us?

Patricia McGaffigan: Total systems safety reflects that safety is a dynamic and real-time product of a system. The approach recognizes the interrelatedness and interdependencies of the obligation of leaders to consistently embrace safety as their purpose; the daily work to prioritize safety culture and support the well-being and safety of the workforce; the meaningful engagement of patients and families; and the application of the science, measurement, and tools of safety, including the learning system. It’s very different from thinking about safety through a focus on reacting to and fixing errors and emphasizing individual excellence in safety, which is unfortunately where healthcare spends most of our time “doing safety.”

The four foundational areas of the National Action Plan were established to reflect this essence. The plan is steeped in several guiding principles, including a commitment to health equity across this work. The first foundational area is culture, leadership, and governance—ensuring that there is a core value and non-negotiable commitment to the prevention and elimination of harm, and leading and governing with habitual excellence that safe, reliable, effective, and equitable care is the primary raison d’être for healthcare. The second area is meaningful patient and family engagement in their own care, and all aspects of care design, delivery, and operations, ensuring that the patient is at the center. The third foundational area is ensuring the safety, wellbeing, and resiliency of the workforce as a precondition to advancing safety, and the strategic unification of work to foster patient and workforce safety and wellbeing. The fourth area is the learning system, with the establishment of networked and continuous learning and forging of reliable learning systems within and across healthcare organizations at the local, regional, and national levels to advance widespread sharing, learning, and improvement. This foundational area is associated with the realization that our status quo approach to safety is insufficient for safety to be realized.

Sarah Mossburg: How does the National Action Plan recommend creating sustainable safety systems and how does that differ from how we have historically thought about safety?

Patricia McGaffigan: One of the ways I characterize the difference in our traditional approach to safety and the intent of the National Action Plan is that we haven’t necessarily been able to see the forest for the trees. We’re spending lots of time focusing on the circumscribed harms, continually trimming the trees without necessarily focusing on the forest, which is the habitat that generates nutrients for the ecosystem, the engine that enables species to not only survive, but thrive. This is analogous to our status quo approach of chipping away at the margins of safety through constant layering of circumscribed improvement projects without addressing the bigger picture fortification of the ecosystem in which care is received and delivered. We’ll continue to have this same conversation another 20 years from now if something doesn’t radically change.

One example is in our work to implement bundles of care, which we know is important, however if the systems are not well designed to support and reflect healthcare workers’ workflow, and the conditions in which they work, and people are just told to do something without playing a role in codesign and implementation of the intervention, bundles are less likely to be successfully  implemented or effective.

Medication error is another example. Solutions often emphasize more training and compliance with policies, again with a focus on expecting people to try harder and get better. However, we’re not necessarily addressing the reasons why an error has occurred, and more importantly focusing on controlling risk in the first place. We’ve got important assistive technologies such as bar code administration solutions. However, if they’re not universally available in every setting where medications are administered, the system has obvious vulnerabilities that must be addressed.

Sarah Mossburg: How can organizations use the National Action Plan in their improvement efforts? What strategies can they use? What would you recommend?

Patricia McGaffigan: Many organizations are using the organizational Self-Assessment Tool, a component of the National Action Plan package, to determine a starting point. Organizations can use the online Self-Assessment Tool to identify gaps in current performance on the recommendations in the National Action Plan. One of the most important steps is to identify an executive champion who is fully committed and accountable for overseeing tests of change, monitoring progress, and supporting continuous improvement work.

For example, one section of the tool relates to whether job descriptions for senior leaders include their accountability for safety. Organizations are nearly always mentioning this element as one where there’s room for improvement, and it’s prompted a lot of important conversation that they may never have been addressed up until now. It changes the entire lens of how safety is operationalized in the daily work of leaders, and how all leaders must be held accountable for safety.

Across each of the four foundational areas, organizations can identify what they’re doing well and where they have opportunities to prioritize their focused improvement. It’s important to recognize that the four foundational areas are regarded as interdependent. This means that if organizations focus only on one foundational area, such as culture, leadership, and governance, without some balanced attention across other areas, we’ll have less likelihood of advancing safety.

Sarah Mossburg: What do you see as the next steps in patient safety and the National Steering Committee after the release of the call to action?

Patricia McGaffigan: Creating and releasing the National Action Plan was a testimony to the commitment and collaboration of the NSC members, however this was step one, and any plan is only valuable if it’s implemented and leading to improvement. Organizations such as MemorialCare, Ascension Health, and ECRI, to name a few, are examples of early adopters, and have actively and transparently shared their experience, progress, and lessons learned in webinars and at conferences and are paving the way for all organizations to reset and fortify their commitment to safety and the elimination of harm. IHI is responding to requests for coaching and the creation of learning and action networks to support testing and scaling of implementation. We have an implementation workgroup that is providing real-time feedback on their experiences. AHRQ and the Department of Health and Human Services are chartering the National Action Alliance to Advance Patient Safety. While plans are still being finalized, they have initiated a webinar series on each of the foundational areas.

One of the lower scoring foundational areas that we’ve observed in organizations that have used the Organizational Self-Assessment Tool is the patient and family engagement foundational area. I believe we have an urgent need to reverse the near-impermeable barriers to patient and care partner engagement during the pandemic for not only their own care but also in partnering with healthcare organizations to improve care design and delivery. 

Aligned with our work to radically reorient our thinking and approach to safety to place more emphasis on prevention is the need to reevaluate and reform the current performance measurement and incentives systems that consume enormous human and financial resources as we chase after measuring, investigating, and addressing errors and harms.  The IHI’s Lucian Leape Institute convened a Salzburg Global Seminar to create principles for safety measurement to move measurement into action, and is actively partnering to improve performance measurement of quality.

Another next step is addressing the need to systematically build competencies in safety across prelicensure and the career trajectory for everyone in healthcare, regardless of whether they hold a formal safety title. The Texas College of Osteopathic Medicine at the University of North Texas Health Science Center has taken the recommendations of IHI’s Lucian Leape Institute to reform education, and redesigned their medical school curriculum to build knowledge and competencies of earlier-stage healthcare professionals. Every third-year student goes through a fully redesigned course that incorporates the Certified Professional in Patient Safety (CPPS) review course and sits for the CPPS exam. Ninety-eight percent of graduates enter their residencies holding the CPPS credential, yet most important is that they are entering their residencies with competency levels and achievements that are substantially ahead of prior graduates. We are partnering with other academic programs to do the same. 

There is also a critical need to address the joy and meaning of the workforce, not because these are sentimental aspirations but because they are integral for patient and workforce safety and well-being. There’s been a tendency to characterize all workforce challenges as burnout and placing a disproportionate burden on individuals to become more resilient. As with patients, there’s a very real need to accurately diagnosis what’s troubling our workforce and distinguish among conditions such as burnout, moral distress and injury, and compassion fatigue, which are different conditions with different manifestations and solutions. These work-acquired conditions require attention to and control of risks to enrich the healthcare workforce pipeline and ensure the conditions to support a thriving workforce that brings out the best in its ability to provide safe, reliable, and equitable care. An example of a related initiative that I’m especially excited about is our learning and action network funded by the Johnson and Johnson foundation to attract, support, and strengthen a thriving and diverse nursing workforce through nurse-led care delivery solutions.  

Sarah Mossburg: Thank you, Patricia. I really appreciate the time that you have given us for this interview. This has been really interesting.

Patricia McGaffigan: Thank you.