In Conversation with Carole Stockmeier about Zero Harm: Striving to Reduce Preventable Harms – Point, Counterpoint, and Areas of Agreement

Carole A. Stockmeier; Sarah Mossburg; Merton Lee

In Conversation with Carole Stockmeier about Zero Harm: Striving to Reduce Preventable Harms – Point, Counterpoint, and Areas of Agreement

Carole Stockmeier, Sarah Mossburg, Lee Merton | September 24, 2024

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Editor’s note: Carole Stockmeier, MHA, BS, is the Senior Vice President of Safety and Reliability Solutions at Press Ganey, with over 20 years of experience in safety science and high reliability organizations. We spoke to her about zero harm and patient safety.

Sarah Mossburg: Please tell us a bit about yourself and describe your current role.

Carole Stockmeier: For over 20 years, I’ve had the pleasure of helping healthcare organizations learn safety science, practice high reliability organizing, and most importantly, improve outcomes and experience for patients and workforce. I currently serve as the Senior Vice President of Safety & Reliability at Press Ganey. Prior to joining Press Ganey, I had the honor of being part of the founding team and Chief Operating Officer of HPI (Healthcare Performance Improvement). I live in the eastern part of Virginia, where I began my career with Sentara Healthcare and served as the Director of Safety and Performance Excellence. As a healthcare professional as well as a cancer survivor, I have safety (and harm) experience from both a professional and patient perspective.

Sarah Mossburg: Could you start the conversation by explaining the concept of zero harm? What is zero harm?

Carole Stockmeier: Patients come to us with faith, hope, and trust that we will restore health and heal wounds. When errors and mistakes result in harm, we fail in our mission and fail those we serve. Safety is a commitment we make to the patients we serve, and the goal of that commitment is zero harm.

We have the same obligation to our workforce: to keep each other safe while carrying out our mission so our workforce can be their best, both for the patients we serve and their families.

In the early 2000s, preventing harm was focused primarily on physical harm to patients and slips, trips, and needle sticks for the workforce. That has evolved. Our commitment to zero harm applies to physical as well as emotional harm, to patients as well as workforce, and to acute care as well as ambulatory, home care, hospital at home, and telehealth.

Sarah Mossburg: Could you speak to why you think zero harm is an important goal?

Carole Stockmeier: Safety as an uncompromisable value and zero harm as the goal are important and powerful alignment tools that enable three things. First, they set our direction both corporately and individually. They align team members, regardless of role or rank, around our purpose of healing without harm. Second, they guide our path in moment-to-moment decisionmaking—whether in the boardroom, the bedside or the boiler room—among what could seem to be endless competing priorities of supplies, staffing, satisfaction, finances, and efficiency. And third, the aspirational goal of zero harm inspires improvement, even in areas that today may be perceived as issues that are not preventable. Many known complications of yesterday are preventable conditions today. In a learning organization, an event of harm creates a zero harm gap that we yearn to close. It causes us to ask, “What were the contributing factors that led to this event, and how can we prevent them from occurring in the future.”

Sarah Mossburg: Are there situations where a zero harm approach to goal setting has been successful?

Carole Stockmeier: One example likely familiar to everyone is ventilator-associated pneumonia or VAP. VAP used to be considered a known complication of being on a ventilator. Then we learned that there are specific things you can do to prevent it: elevate the head of the bed, daily sedation vacation and assessment of readiness to extubate, secretion drainage, and oral hygiene. With knowledge of this evidence-based process bundle, units and organizations began tracking “days since last VAP” and setting goals of zero VAP. Setting the aspirational goal of zero harm rather than incremental goals makes you think differently about strategies and interventions for improvement.

The evidence-based approach is true when it comes to preventing errors and mistakes that can lead to other types of patient and workforce harm. Human performance in complex systems is not random. We know how humans experience error, we know the conditions that make error more likely, and we know the individual, team, and leadership behaviors and processes that reduce the probability of experiencing errors and catching errors that occur before they lead to an event. Combine this prevention strategy with a spirit of continuous learning from successes and failures, and progress toward zero harm is possible. Does it mean that you won't ever have an event? No. Yet, similar to VAP, organizations with advanced safety and organizational learning systems go for lengths of time without experiencing a serious safety event. And when an event does occur, they focus on understanding the root causes and identifying corrective actions to prevent recurrence.

Sarah Mossburg: You’ve probably heard the concern that zero harm can be unattainable or unrealistic. You just spoke to the fact that harm does happen even in organizations that have a zero-harm goal. And so, folks who have that view tend to say we shouldn't set zero harm as a goal if it's unrealistic or unattainable. Do you think that's a misunderstanding of your viewpoint?

Carole Stockmeier: I would say that zero harm is both aspirational and attainable. Progress doesn’t result from not setting a goal because we might not achieve it. We have a goal of zero harm because we should aspire to nothing less and patients and team members should not experience preventable harm. The role of leadership goes beyond saying, “Have a safe day today,” to creating the culture, structure, processes, protocols, and environment that enable having a safe day. And, when we do have an event of harm, the role of the leader is to help the organization pick itself up, learn from that event, and manage forward to make today a safe and exceptional experience for patients and workforce. Critics often argue that setting a zero harm goal and then having an event can be demoralizing to staff. We have observed and have data that demonstrates the opposite. Organizations that prioritize safety and demonstrate that commitment in word and deed actually have a more engaged workforce.

Sarah Mossburg: Could you speak more about how organizational context is an important part of setting a zero harm goal?

Carole Stockmeier: In a punitive environment, where there's fear of punishment for making an error or a mistake and where organizational learning does not thrive, the hammer of a zero harm goal can drive reporting down. Yet in the context of a leadership-driven organizational commitment to safety as a core value with culture, processes, and technology that support a safe, high quality, and exceptional experience, a zero harm goal emanates as a natural fit. What other acceptable goal is there when it comes to harm? That's what makes the difference. Zero harm needs to be positioned in the context of an organizational commitment to safety as a core value. Safety as the core value means that the commitment to zero harm is not just some of the time, but all the time, and it needs to be reflected in the vision, mission, strategy, goals, and most importantly, the day-to-day words and actions of the organization. Zero harm and safety culture go hand-in-hand, an uncompromising commitment to safety as a core value with zero harm as the goal.

Sarah Mossburg: So having that safety culture and leader’s support of safety culture in what they say and do is critical to ensuring that a zero harm goal doesn't potentially lead to decreased reporting?

Carole Stockmeier: More than leader support, safety culture requires the personal commitment of leaders. And that has to start at the top. Organizations where safety culture is an intentional focus and responsibility of the board and the CEO are the most successful in achieving and sustaining results in patient and workforce safety. Why is board involvement so important? Many organizations have made great strides in safety culture improvement under the leadership of a CEO who personally and passionately led the way. And when that CEO left, those organizations lost those gains in a matter of months when the new CEO didn’t lead the way as personally and passionately. The Board plays a critical role in hiring a leader who will provide continuity of commitment and purpose when it comes to safety culture.

Sarah Mossburg: You mentioned the importance of a culture of safety and organizational context, which is likely an area of common ground with someone who might have an opposing view on zero harm as a goal. Are there other areas where you probably agree with someone who holds an opposing view?

Carole Stockmeier: When considered in the context of a culture of safety and high reliability organizing, I’m sure most healthcare leaders would be closely aligned that the safety goal should be zero harm. Who would want to receive care where there is a preventable harm goal other than zero?

Sarah Mossburg: I would love to hear your thoughts on regulatory incentives for zero harm. The proposed CMS Patient Safety Structural Measure includes a specification that an organization's strategic plan publicly shares a commitment to zero preventable harm. What is your reaction to CMS putting that into a proposed quality measure?

Carole Stockmeier: There's been a lot of dialogue lately about whether the proposed CMS Patient Safety Structural Measure is a step in the right direction or a step too far. It is a step in the right direction. Ideally, an industry would mobilize itself to take a stand on safety and harm prevention issues. While many efforts have advanced the cause, so far, none have resulted in a unified culture of safety across the healthcare industry. The Patient Safety Structural Measure is an attestation-based measure that encourages hospitals to assess and work toward a culture, structures, and processes that drive a safe, high-quality experience. These kinds of leading and real-time indicators are the right focal point in the effort to change outcomes in patient and workforce safety.

Sarah Mossburg: If zero harm is part of a regulatory call, what are your thoughts on the risk for organizations that don't have a strong safety culture espousing this type of zero harm goal?

Carole Stockmeier: As we have talked about, it is important for a zero harm goal to be grounded in an organizational commitment to patient and workforce safety. While the CMS Patient Safety Structural Measure includes the goal of zero preventable harm, it frames that goal well within the five domains of governing board and leadership commitment, strategic planning and organizational priority, safety culture and organizational learning, accountability and transparency, and patient and family engagement. The practices of organizations leading the way will hopefully become the tipping point for making the best practices of some the common practices of all. The CMS structural measure is a push in the right direction and in the right way.

Sarah Mossburg: Well, thank you so much for this conversation. It's been really interesting, and I appreciate hearing all your thoughts on these issues.

Carole Stockmeier: You're welcome.

Zero Harm: Striving to Reduce Preventable Harms – Point, Counterpoint, and Areas of Agreement

September 24, 2024

The Hippocratic Oath, “First do no harm,” serves as the cornerstone of medical ethics and core value of healthcare: Patients should not be harmed by medical treatment. Yet, current estimates suggest that 10% to12% of hospitalized patients are harmed during their care and that half of this harm is preventable. While the causes of preventable harms and methods to prevent them continue to be identified and reported, some patient safety advocates have espoused a zero harm principle. Zero Harm: How to Achieve Patient and Workforce Safety in Healthcare articulates the importance of establishing a goal of zero harm and shares principles, practices, and case studies in applying safety science and high reliability organizing to improve safety and advance toward zero harm. The editors argue that safety science research has shown that apparent barriers to zero harm, such as high cost, appear to be lowered as safety is achieved, and harms not traditionally associated with lapses in patient safety, such as worker stress, are also reduced.¹

Skeptics of setting zero harm goals have noted that the unattainable quality of zero harm, which its proponents acknowledge, risks lowering morale or may incentivize reduced reporting of errors, as articulated in a recent commentary. Even as patient safety experts debate zero harm as a stated goal and discuss its potential effects, they agree on the importance of a strong culture that supports safety and always seeks safer care.

Point

Zero Harm Goals Contribute to Improving Patient Safety

Zero harm goes beyond simply declaring a goal of zero preventable harm – it is an organizational commitment to safety as a core value combined with a systems-based approach to promoting culture and processes that support safe and reliable operations. A Canadian health system recently reported on their reduction in preventable harms after adopting a high-reliability organizing approach. They note that in an accreditation review they identified areas for improvement in patient safety, and there were anecdotal claims of underreporting.² They developed a “zero harm” initiative based on safety culture and found a 37% increase in reporting, and decreases in preventable harm: 39% decrease in injuries with falls, 37% fewer pressure injuries and a 34% reduction in central line-associated blood stream infections.² These reductions were achieved through a five-part strategy including engaging leadership and overhauling the system’s approach to patient safety.² Efforts were led from the top, with the chief executive officer of the hospital system communicating safety priorities and the importance or promoting safety in team meetings throughout the hospital system.² They also implemented dashboards to track harms and sought to define themselves as a learning health system by deploying an education program on patient safety throughout the hospital.² Prioritizing zero harm as a leadership initiative, as this Canadian group did, is a tenet of a strong safety culture and has been used by the South Carolina Hospital Association as described in their published blueprint which draws from a national safety culture initiative. Describing six domains across which safety culture should be directed, the South Carolina Hospital Association notes that, since the 2013 launch of their Certified Zero Harm Awards, member hospitals have achieved up to 88 month stretches of zero harm as validated by the state’s Department of Health and Environmental Control with two-thirds of member hospitals receiving Zero Harm Awards. In another case report, Community Health Systems in Tennessee reduced their rate of serious safety events by 89% through implementation of high-reliability and organizational learning principles.

In describing the achievements of the health systems above, their rate of preventable harm is not zero, or not zero forever. So why do safety culture proponents advocate the adoption of a seemingly unachievable goal? A commentator notes that evidence on safety in other fields suggests that ambitious goals can help create a movement, in which individuals feel like their efforts are part of a larger challenge, many with “zero” as their goals, such as “Vision Zero” to reduce deaths from road traffic, “Zero Suicide,” and “Built for Zero” to end homelessness for veterans. Indeed, these kinds of ambitious goals could be thought of as a type of “Big Hairy Audacious Goal,” a management principle espoused by Jim Collins and Jerry Porras, in which setting a lofty goal solves the problem of inspiring and recruiting colllaborators.³ Another aspect of setting a zero harm goal is that zero harm may enable a health system to remain consistent in its drive toward patient safety, not letting patient safety be a greater or lesser priority based on performance on benchmarks, which can shift.⁴ Arguably, benchmarks that focus on performing better than competitors eventually saturate, so further achievement becomes less strongly incentivized. Setting a goal of zero, may ensure better reliability long term in prioritizing safety goals.⁴ It may be argued that a zero harm goal is untenable due to expense. However, with the cost of preventable harm estimated to be as high as $19.5 billion per year in the United States, reducing harm is likely to lead to cost savings.³ Evidence, such as the Canadian hospital system and South Carolina’s and Tennessee’s successes, suggests that zero harm initiatives can jump start the transformation of a health system’s safety culture and that goals that seem impossible, actually achieving zero preventable harm over an increasing period of time, can be achieved with consistent leadership buy-in.

Counterpoint

Zero Harm Goals May Have Unintended Negative Safety Consequences

The rationale for setting zero harm as an organizational goal is drawn from safety science, specifically high reliability theory which suggests that with greater effort accidents can be reduced potentially to zero.¹ Critics of zero harm have noted an alternative conception of error and complex systems in safety science, a competing theory called Normal Accident Theory, which posits that some level of accident is intrinsic to highly complex systems, regardless of effort. Indeed, the amount of effort expended in the resource scarce environment of hospital administration suggests one problem with a zero harm goal uncritically adopted, that hospital administration may divert resources that could improve clinical outcomes for an unattainable safety goal of zero.⁵ This tension between allocating resources for zero harm initiatives and other areas of healthcare, could be a significant downside to pursuing zero harm, argues surgeon Thomas Aloia when considering zero harm goals in surgery.⁶ Based on surveys, younger surgeons are preoccupied by error and dread reporting avoidable negative outcomes, and this preoccupation may contribute to the high rates of burnout that correspond temporally with an increased emphasis on safety in surgery that dates from the past ten years.⁶

Aside from the question of resource allocation, commentators have also questioned how zero avoidable harm can be reliably measured, and the consequences of unreliable metrics. Statistically, patient harm is rare enough that reliably assessing whether a harm is preventable or not is hampered by insufficient data.⁵ For patient mortality, where the most data would be available, a systematic review found that 8-17 reviews of a single death would be necessary to reliably determine if it were preventable or not, and preventability is even harder to determine for non-fatal harms like healthcare associated infection.⁵ Unreliable metrics on preventable harm make it difficult to accurately measure these harms and thus difficult to assess whether initiatives such as zero harm goals are working, and the subjective dimension in determining whether a harm is avoidable or not makes reporting harms vulnerable to unconscious or conscious misclassification. The temptation to under-report or misreport harm increases, argues critics, if the goal is unrealistic.^5,7

Commentators also point out that in practice, zero harm initiatives may target harms that are preventable by consensus, and overlook more difficult to assess possible harms. For instance, a hospital may focus on eliminating severe pressure injuries as a preventable harm, but not direct attention to other preventable but more difficult to assess harms, such as over-sedation, which can result in respiratory arrest or stroke.⁷ Whether a healthcare organization focuses on bed sores, oversedation, or both may be thought of in terms of that health system’s overall approach to safety and harm reduction. It may be that health systems following a “Safety I” approach in which harm is thought to arise from linear, repeated processes that can be reliably improved, can result in focusing on reducing harms like bed sores, without addressing more complex harms like over-sedation. Alternatively, a “Safety II” approach sees healthcare delivery as non-linear, and complex, so repeatable interventions alone will not necessarily result in safe, high quality care. Instead, with “Safety II,” risk reduction can motivate improvements in patient safety by focusing on risks more than harm, in fact, even unanticipated harm might be reduced by careful attention to risk.⁸

Zero harm initiatives assume that preventable harm is measurable and that staff working together can find and implement what has eluded researchers in patient safety: consistent, widely applicable strategies to eliminate harm. Skeptics of zero harm suggest that it is impossible to measure preventable harm reliably and that the causes of harm are too complex to altogether eliminate.

Areas of Agreement About Zero Harm

Proponents and critics disagree on the likely effect of setting zero harm as a goal. Does a zero harm goal contribute to reducing preventable harm, or does it exploit unreliable metrics? Will health systems save money, or will pursuing zero harm put strain on limited health system resources? Will health systems free up resources as harms become less frequent, or will efforts to reach zero harm draw resources away from areas that could better improve clinical outcomes? Ultimately those who espouse zero harm as a goal and those who are skeptical agree that a patient should not be harmed while undergoing medical treatment and that striving for safer care delivery is an on-going journey.

Carole Stockmeier, MHA, BS
Senior Vice President of Safety and Reliability
Press Ganey
South Bend, IN

Eric Thomas, MD, MPH
Director of the University of Texas Houston Memorial Hermann Center for Healthcare Quality and Safety
Associate Dean for Healthcare Quality
McGovern Medical School at University of Texas Health
Houston, TX

Merton Lee, PharmD, PhD
Researcher
American Institutes for Research (AIR)
Columbia, MD

Sarah E. Mossburg, RN, PhD
Senior Researcher
AIR
Arlington, VA

References

Clapper C, Merlino J, Stockmeier C. Zero Harm: How to Achieve Patient and Workforce Safety in Healthcare. McGraw-Hill; 2019.
Wilson MA, Sinno M, Hacker Teper M, et al. Toward zero harm: Mackenzie Health’s journey toward becoming a high reliability organization and eliminating avoidable harm. J Patient Saf. 2022;18(7):680-685. [Available at]
Gandhi TK, Feeley D, Schummers D. Zero harm in health care. NEJM Catalyst. 2020;1(2). [Available at]
Davis DJ. Going beyond benchmarks: zero harm for every patient, every time. J Nurs Adm. 2015;45(4):183-184. [Available at]
Meddings J, Saint S, Lilford R, et al. Targeting zero harm: a stretch goal that risks breaking the spring. NEJM Catalyst. 2020;1(4). [Available at]
Aloia TA. Should zero harm be our goal? Ann Surg. 2020;271(1):33-36. [Free full text]
Stockwell DC, Kayes DC, Thomas EJ. Patient safety: where to aim when zero harm is not the target-a case for learning and resilience. J Patient Saf. 2022;18(5):e877-e882. [Available at]
Thomas EJ. The harms of promoting “Zero Harm.” BMJ Qual Saf. 2020;29(1):4-6. [Free ful text]

This project was funded under contract number 75Q80119C00004 from the Agency for Healthcare Research and Quality (AHRQ), U.S. Department of Health and Human Services. The authors are solely responsible for this report’s contents, findings, and conclusions, which do not necessarily represent the views of AHRQ. Readers should not interpret any statement in this report as an official position of AHRQ or of the U.S. Department of Health and Human Services. None of the authors has any affiliation or financial involvement that conflicts with the material presented in this report. View AHRQ Disclaimers