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IN DEPTH

Zero Harm in Health Care


Tejal K. Gandhi, MD, MPH, CPPS, Derek Feeley, , Dan
Schummers,
Vol. 1 No. 2  |  February 19, 2020
DOI: 10.1056/CAT.19.1137

Despite some real success in improving patient safety


in recent years, achieving the goal of zero harm to
patients, families, and the health care workforce is a massive undertaking that requires a
comprehensive effort. A robust systems-focused approach to improving safety requires four
interdependent elements: effectively managing change by tending to the psychology of
change; creating and sustaining a culture of safety; developing and leveraging an optimal
learning system; and engaging patients in the codesign of care and improvement.

“First, do no harm.” Those four words — derived from the Hippocratic Oath — represent a powerful
articulation of the clinician’s primary responsibility. They have entered into the modern culture of
medicine and align squarely with the campaigns for patient safety and the drive to zero harm.

The aphorism has power because of how it begins: First. Avoiding harm to patients is a clinician’s
first responsibility; all others flow from it. This is also true of the effort to improve the quality of
health care: Improving patient safety is foundational to improving other domains of care quality.

“First, do no harm” is also powerful because it is absolute. If the phrase were, “First, do as little
harm as possible,” it wouldn’t have the same impact. Zero harm is the goal. Yetzero is a controversial
term these days in the field of patient safety. One of the biggest shifts in the field over the past 15
years is that certain harms, especially certain health care–associated infections, that were once
considered inevitable have been proven to be preventable. Evidence shows thatgetting to zero is
achievable. Mercy Hospital in Buffalo, New York, went nearly 18 months without a single case of
ventilator-associated pneumonia.1 Sutter Roseville Medical Center in California went 7 years with
zero central line–associated bloodstream infections.2

The controversy around zero emerges when someone asks, “But forever?” or “For all health care–
associated infections?” Ifgetting to zero is the same aspermanently eliminating all harm, then even the
most ardent champions of patient safety would have to admit defeat. Indeed, some experts argue

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that targeting zero is an unnecessary burden on already stressed and overworked clinicians.3 Vince
Lombardi, the venerated head coach of the NFL’s Green Bay Packers in the 1960s, famously told
his players that, “Perfection is not attainable. But if we chase perfection, we can catch excellence.”
This is exactly what’s occurring in ambitious, forward-looking health systems today. By chasing
zero, they are achieving excellence.

Aiming High (or Is It “Aiming Low”?)


So, why zero harm? Why should the stated aim be something that rational people have to admit
is technically unattainable across a large health system? It’s because the stakes are so high. In
2000, the Institute of Medicine report,To Err Is Human: Building a Safer Health System, estimated
the number of deaths per year due to failures in patient safety in hospitals to be 98,000.4 More
recent estimates have put that number as high as 400,000.5 Regardless of which estimate is most
accurate, breakdowns in patient safety are a leading cause of death in the U.S.6 And mortality
statistics tell only a part of the story; incidents of nonfatal harm to patients are also unacceptably
prevalent. Research shows that approximately 1 in 10 patients suffers an adverse event during
hospitalization.7 Approximately 50% of surgical procedures involve a medication error and/or an
adverse drug event.8 Many of these harms have an impact on individuals for the rest of their lives.

“ ‘First, do no harm’ is powerful because it is absolute. If the phrase


were, ‘First, do as little harm as possible,’ it wouldn’t have the same
impact. Zero harm is the goal."

Globally, the patient safety challenges are even greater. Three major reports on global health
care quality and safety were published in 2018: one from the National Academy of Medicine9;
one from the World Health Organization (WHO), Organisation for Economic Co-operation and
Development (OECD), and World Bank10; and one from the Lancet Global Health Commission
on High-Quality Health Systems.11 Together, these reports paint a grim picture: The global
“quality chasm,” especially in low- and middle-income countries, is bigger than the one in the U.S.
Hospitalizations in low- and middle-income countries lead to 134 million adverse events each year,
contributing to more than 2.5 million deaths per year.9 Approximately 7% of hospitalized patients
in high-income countries and 10% in low-income countries will suffer health care–associated
infections. Patient harm is the 14th-leading contributor to the global burden of disease.10

Harm caused by patient safety failures also carries an enormous price tag. Any effort to improve
value in health care must include efforts to improve safety. Research published in 2012 estimated
the direct costs of preventable harm at $19.5 billion per year (most of which was due to additional
medical expenses necessitated by the harm).12 If the indirect costs of preventable harm are
included, the estimate approaches $1 trillion annually in the U.S. alone.12 Across OECD nations,
more than 10% of total hospital expenditures are used to treat harms caused by preventable
medical errors and health care–associated infections.10 Despite the high stakes, progress has
been frustratingly slow, incremental, and localized. For these reasons, the National Patient Safety

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Foundation (NPSF) called for acceleration of efforts to eradicate harm in its 2015 report,Free from
Harm: Accelerating Patient Safety Improvement Fifteen Years after To Err Is Human.13

The scope of the patient safety problem expands when one considers its impact on the health
care workforce. Patients and their families are not the only ones to suffer when preventable
harm occurs. Caregivers involved in the harm are also affected, often feeling guilt, shame, and
in some cases, depression. A workforce facing what many call a “crisis of burnout” can ill afford
these secondary, but very real, harms. The problem grows even more if the concept of safety is
expanded to workforce safety in health care settings (as caregivers themselves are too often directly
harmed) and if the concept of harm is expanded to include psychological harm as well as physical
harm. Health care must move to a broader definition of harm that includes physical, emotional,
psychological, sociobehavioral, and financial harm; harm to patients and those who care for them;
and harm across the entire continuum of care (from hospital to outpatient settings to home) (Figure
1).

FIGURE 1

In thinking through how best to accelerate progress and eradicate harm, the National Patient
Safety Foundation (NPSF) looked to past successes in eradication and found a compelling
model of effective, broad collaboration in the coordinated responses to public health crises (e.g.,
smallpox, polio, smoking), which demonstrated that such collaboration was both possible and

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successful. Initiatives such as the Institute for Healthcare Improvement’s (IHI’s) 100,000 Lives
Campaignand 5 Million Lives Campaign, as well as the Centers for Medicare & Medicaid Services’
(CMS’s) Partnership for Patients, focused and coordinated efforts to reduce harm and death.
These initiatives had an impact: from 2010 to 2015, millions of expected instances of hospital-
acquired conditions such as central line–associated bloodstream infections, ventilator-associated
pneumonias, and catheter-associated urinary tract infections were prevented.14 Inspired by these
successes, the NPSF issued a call to action and urged the entire health care industry to adopt a
public health approach to preventing harm in health care (Figure 2). Key elements of this approach
include clearly defining the problem and setting national goals, broad collaboration among
stakeholders, community engagement, and effective measurement.15

FIGURE 2

The Appeal ofZero


One of the enduring lessons of large-scale collaborative efforts is that stakeholders are motivated
by being part of something larger than themselves. Once stakeholders are a part of a larger
movement, inspiration comes from the momentum of the movement itself and from the
interactions with other stakeholders who are working toward the same end. Getting stakeholders
to sign on in the first place is a different challenge. One solution is to articulate what Jim Collins
and Jerry Porras, in their classic book, Built to Last, call a “Big Hairy Audacious Goal (BHAG)”16 —
thus, IHI named its initiatives “100,000 Lives” and “5 Million Lives.” Inspired by IHI’s big hairy
audacious goals related to reducing mortality and morbidity caused by health care, Community

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Solutionsnamed its initiative to curb chronic homelessness in the U.S. the “100,000 Homes
Campaign.” After the conclusion of this initial effort, leaders at Community Solutions thought
about how to build momentum and awareness. They named their follow-up initiative — aimed at
ending veteran and chronic homelessness — “Built for Zero” (originally “Zero: 2016”). Similarly,
“Vision Zero” is a strategy for eliminating deaths from road traffic. Started in Sweden in the 1990s,
this initiative has spread throughout Europe and is now expanding to cities and municipalities in
the U.S. “Zero Suicide” aims to eliminate suicide deaths for people under the care of health and
behavioral health systems. There is simply no bigger, hairier, or more audacious goal thangetting to
zero.

“ If getting to zero is the same aspermanently eliminating all harm,


then even the most ardent champions of patient safety would have to
admit defeat."

Another reason for focusing on zero as a goal for patient safety is that it’s a door into reliability
science. Applying the principles of reliability — evaluating, calculating, and improving the
reliability of a complex system — is a bulwark against one of the most common frustrations in
the field: regression. High reliability is the necessary complement to improvement, ensuring that
improvements are sustained over time. Again, failing to achieve perfection (zero defects in the
language of reliability) is not failure. Failure would be not using the principles of reliability to ensure
that attention is paid to system performance over the long term.

And zero is possible: Several intensive care units around the country (e.g., Sutter Roseville
Medical Center in California, Children’s Hospital and Clinic–St. Paul, Tufts Medical Center in
Massachusetts) have had zero central line infections for years, an achievement that would have
been considered unthinkable 20 years ago when these infections were considered just part of doing
business. Health care leaders and professionals need to adopt the mindset that zero is possible and
achievable.

Additional changes in mindset are required to achieve this ambitious goal. These changes expand
the understanding of the key issues of safety in health care and together create a comprehensive
view of the full scope of the problem.

A Broader Definition of Harm


From Priority to Core Value
Over the last 20 years, health systems around the world have prioritized patient safety. This
development represents real progress. But priorities can shift. Priorities are usually associated
with a specific time period (e.g., “This is my priority today” or “This is a priority for us this year”).
Values, on the other hand, are intended to be permanent. Patient safety shouldn’t be thought as
an organizational initiative or a collection of projects; it needs to be a core value. Patient safety
can’t be merely “what we’re currently working on”; it needs to become “how we do things around

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here.” While this distinction might seem to be little more than a semantic difference, it is in fact a
powerful shift in culture. And culture change, as will be discussed, is essential.

From Physical Harm to ALL Types of Harm


The problem of physical harm to patients in health care is relatively well understood and
appreciated. Harder to quantify and fully conceptualize is the problem of psychological harm.
Leaders at Beth Israel Deaconess Medical Center (BIDMC) in Boston recognized the prevalence of
this type of harm and worked to address it in many of the same ways in which they address physical
harm. They decided to frame the issue of emotional and psychological harm in terms of dignity
and respect. BIDMC definesdignity as the “intrinsic, unconditional value of all persons” andrespect
as the “sum of actions that honor or acknowledge a person’s dignity.”17 It’s not hard to imagine the
threats to dignity and respect in health care settings. Patients are often physically, emotionally, and
psychologically vulnerable. The frantic pace of health care means that caregivers are often rushed,
overburdened, and distracted. Even without any ill intent, treating a patient disrespectfully and/or
injuring their dignity can and does happen.

At BIDMC, leaders investigate instances of disrespect with the same focus and rigor with which
they investigate instances of preventable physical harm. In the process, they have found that while
disrespectful comments or other transgressions made by individuals are sometimes the source
of psychological harm, common systems-based failures (e.g., poor or missed communication,
breaches of confidentiality, uncoordinated care, etc.) also can cause harm. An important form of
psychological harm that can result from such breakdowns is what BIDMC calls sociobehavioral
harm. In many cases, this harm manifests as a general distrust of health care, which can lead to
an unwillingness to seek care when needed. This particular problem is exacerbated when the
psychological harm happens across racial or ethnic differences.

In the U.S., there is a long and terrible history of health care intentionally harming people of color in
the purported interest of science and research — the infamous Tuskegee Experiment on untreated
syphilis in African-American men being just one example. These crimes have created a general, and
justified, distrust of health care among people of color. In addition to these inexcusable, intentional
harms are the uncountable instances of bias — often unconscious bias — tainting the quality of
care experienced by people of color. In a 2017 survey of more than 2,500 adults, disrespect was the
fourth most frequent patient-perceived medical error, cited by 39% of respondents.18 The risks to
dignity and trust are real and, like physical harm, are preventable.

From Harm to Patients to Harm to ALL


Ensuring the physical and psychological safety of the workforce and caregivers is a necessary
precondition to ensuring safety for patients. Patient safety experts now have a better understanding
of the very real psychological harms (e.g., guilt, shame, depression) suffered by caregivers when
they are involved in harming a patient. Traditional hierarchies, power imbalances, and bias
create plentiful opportunities for caregivers to be psychologically or emotionally harmed by their
colleagues. Stories of experienced and powerful physicians treating younger physicians, nurses,
and other staff members with disrespect are common. And these kinds of harms happen across and

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within every level of the health care workforce. Too often, these instances of harm are dismissed
as being the unfortunate product of a small number of “bad actors.” As with every risk to safety,
however, the real problem lies within systems.

“ The definition of harm needs to be broadened. Emotional,


psychological, and sociobehavioral harm is as real, as impactful, and
as preventable as physical harm."

There are, of course, real risks of direct physical harm to caregivers as well. Health care is
increasingly understood to be a dangerous place for its own workforce. Millions of clinicians have
been harmed while doing their jobs,19 and these harms are too often thought to be unavoidable.
There is, therefore, a need for another change in mindset around safety: Systems need to be
improved, and attitudes changed, to create a working environment that is free from harm to the
health care workforce as well as to patients.

From Harm in the Hospital to Harm Across the Continuum


The attention paid to patient safety over the past 20 years has largely focused on hospitals. On the
face of it, this focus is understandable. Hospitalized patients are often acutely ill and vulnerable to
certain kinds of physical harm such as infections. Yet safety risks exist across the entire continuum
of care. With the increasing prevalence of chronic disease across the world, more and more patients
are receiving care outside of hospitals. In the U.S. alone, there are nearly 1 billion ambulatory visits
each year, compared with about 35 million hospital admissions each year.20 And the continuum
of care also extends to nursing homes, hospice care, and increasingly, to the home, where the
definition of caregivers expands to include professionals (e.g., home health aides) as well as family
and friends. We know that harms are occurring in all these settings.21

While the risks of physical harm are likely to be greatest for hospitalized patients, the risks of
psychological harm are spread more evenly throughout the care continuum. With so many more
care interactions occurring in ambulatory settings, the overall burden of psychological harm is
likely far greater outside the hospital. Patient safety therefore needs to be a core value in every part
of the health care continuum.

Getting There from Here


The full scope of the safety issues in health care is daunting. Physical harm to patients is happening
not only in hospitals, but across the entire continuum of care. And physical harm is only one of the
safety risks experienced by patients. All of these considerations, coupled with expanding the scope
of the problem to include the real risks to the safety of the workforce and other caregivers, can be
overwhelming to leaders and staff who truly want to eradicate harm from health care. The only
way to comprehensively address all aspects of patient and workforce safety is to use a total systems
approach.

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Successful improvement initiatives depend on engaged and effective leadership. Leaders have
direct responsibility for the overall performance of the systems they lead. And that performance
depends on key leadership responsibilities such as values, culture, and deployment of resources.
Without leadership attention on, and commitment to, a total systems approach to improving safety,
efforts will be wasted and improvements will not be sustained.

Two decades of experience by IHI and other experts in the field have revealed four key, interrelated
elements needed for a successful systems approach to improving safety: (1) change management
(especially attending to the psychology of change), (2) a culture of safety, (3) a learning system, and
(4) patient engagement and codesign of health care.

The Psychology of Change


Change is a human endeavor. Lasting change depends not only on understanding the system and
specific interventions (the what) and methods of change (thehow) but also people engaged in the
system (thewho) and their motivations (thewhy). Failure to appreciate any one of these dimensions,
and how all of the dimensions interact with each other, will hinder both progress and sustainability.

No one doubts the crucial importance of buy-in and engagement at the front lines of care to the
success of any improvement initiative. Leadership by edict is wholly inadequate to the task. But
it’s sometimes easy for leaders to overlook the resistance to change at the front lines. After all, no
one working in health care wants care to be unsafe or to provide low-quality care. Resistance to
change, however, is natural and normal. People naturally fear losing control. They usually don’t
perform well when uncertainty is high. Many people feel unease when surprised. And most people
prefer to continue doing things in their own way. These natural feelings manifest in behaviors and
emotions — complacency, doubt, apathy, hopelessness, rejection, and fear — that collectively create
real impediments to change. In health care, these emotions and behaviors only add to an already
stressful and challenging work environment.

Research by IHI in 2017 informed the development of a psychology of change framework built
on the key principle of activating people’s agency. In this context,agency is defined as “power
+ courage.”Power is the ability to act with purpose and is produced through interdependent
relationships that collectively harness the knowledge, experience, and capacity of people to achieve
an aim.Courage is having the emotional resources to choose to act when facing a challenge. Power
and courage combine to create agency at three levels: (1) self-agency, the ability of an individual to
make choices; (2) interpersonal agency, the collective ability to act together toward an aim; and (3)
system agency, the contextual elements that support the exercise of agency across organizations.22

“ Ensuring the physical and psychological safety of the workforce and


caregivers is a necessary precondition to ensuring safety for patients."

Agency at each level mutually reinforces and amplifies agency at the other levels. Agency starts,
however, with the self, and a key takeaway from studying the psychology of change is that self-
agency is significantly aided when individuals move from a fixed mindset to a growth mindset. This

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notion, developed by Carol Dweck, describes a fixed mindset as one in which individuals believe
their abilities, intelligence, and talents are fixed and unchangeable. A growth mindset is one in
which individuals understand that these traits can be improved through learning, practice, and
persistence. Those with a fixed mindset are far likelier to experience the emotions, and manifest
the behaviors, associated with resistance to change. Those with a growth mindset are far likelier to
embrace and bring about change.23

Leaders who understand the psychology of change can create the conditions that enable people to
individually and collectively exercise their agency and act with purpose to effect change. To do this,
leaders should focus on unleashing intrinsic motivation, building relationships through codesigning
and coproducing change, and sharing power.22

One effective way to unleash intrinsic motivation is the use of public narrative — a technique
developed by Marshall Ganz — which involves personal stories (stories of self), collective stories
(stories of us), and stories of challenges met with hope (stories of now).24 The authors of thePsychology
of Change Framework white paper22 provide a compelling example that relates directly to improving
safety:

“ …anesthesiologist Dr. Michael Rose drew on public narrative to


unleash intrinsic motivation for the widespread adoption of an
evidence-based surgical safety checklist at McLeod Regional Medical
Center in Florence, South Carolina. For 18 months prior, adoption
rates had hovered at 30% despite efforts to raise awareness, train,
market, convince, cajole, and even mandate the use of the checklist.
To unleash intrinsic motivation, Dr. Rose convened surgical team
members to share what called them to enter the health care profession
and care for patients. Team members shared stories of self: loved ones
who experienced harm in hospitals, or injustices in health care. They
described personal trials as children of elderly parents, as spouses,
as parents of young children. They shared universal moments of
grief and loss, or of people who had helped them through profoundly
uncertain moments — and how those people and moments
transformed them as human beings and professionals.

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Through these stories, surgical staff connected to each other and
their intrinsic motivations around patient care. Some described that
they were hearing about each other’s motivations to do the work that
they do for the first time, despite having worked together for more
than 25 years. Dr. Rose and his team then built a story of us and now,
as they shared how the improvement work brought them all closer
to what drew them to medicine: to care for people, safely and justly.
They contrasted the urgent challenge of patient harm with hopeful
stories about patients with improved surgical outcomes as a result
of using the checklist and the positive effects for patients’ families,
employers, the broader community, and hospital staff. The results
followed: 100% sustained utilization of the checklist, 35% decrease
in mortality, and a reduction of 80,000 hours of annual resource
time due to improved performance. In addition, surgical team
members reported improved safety culture measures, increased job
satisfaction, and decreased burnout.22"

Improving any system in health care is complex and challenging. Fully accounting for the
human side of change adds to the complexity. Leaders charged with making real and sustained
improvements in patient and workforce safety need to understand the psychology of change and
the imperative to move from asking, “How can I get all these people to do what I want them to do?”
to the much more effective inquiry, “How can I get all these people to do whatthey want to do?”

Creating and Sustaining a Culture of Safety


Probably the most common aphorism related to managing people or organizations is that “culture
eats strategy for breakfast.” While ubiquitous use of this phrase nearly makes it a cliché, it remains
a valid and essential truth. More than any single element, organizational culture is the key to
accelerating progress toward zero harm in health care. Of course, culture isn’t a single element; it’s
a broad and diverse collection of actions, attitudes, processes, and beliefs that inform everything
that an organization does. Culture is how people face and overcome challenges together. Culture is
how they celebrate successes together. And culture is the vehicle through which they can harness all
of the learning over the past decades to improve systems and make health care free from harm.

“ More than any single element, organizational culture is the key to


accelerating progress toward zero harm in health care."

The NPSF’s Free From Harm report13 included eight recommendations for achieving “Total Systems
Safety,” the first of which was, “Ensure That Leaders Establish and Sustain a Culture of Safety.” The

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Agency for Healthcare Research and Quality (AHRQ) defines a “culture of safety” as one that: (1)
acknowledges the high-risk nature of an organization’s activities and the determination to achieve
consistently safe operations, (2) creates a blame-free environment in which individuals are able to
report errors or near misses without fear of reprimand or punishment, (3) encourages collaboration
across ranks and disciplines to seek solutions to patient safety problems, and (4) demonstrates
organizational commitment through effective use of resources to address safety concerns.25

Despite culture being an area of focus and emphasis in health care since the publication of To Err
Is Human in 2000,4 there is still a long way to go. Recent statistics from AHRQ show that more
than half of culture survey respondents report that they work in a punitive environment.26 Because
of this slow progress, the IHI Lucian Leape Institute and the American College of Healthcare
Executives (ACHE) collaborated on a detailed description of the key elements of the kind of culture
that the AHRQ described (as well as how leaders can create and contribute to such a culture).
Essential leadership actions and behaviors to creating and sustaining a culture of safety include
establishing a compelling vision, building trust, developing the board of directors’ fluency in
patient safety, and setting clear behavioral expectations.27

Creating a compelling vision for safety is where the notion of getting to zero or beingfree from harm
has real power. The NPSF articulated its own compelling vision in 2015: “Creating a world where
patients and those who care for them are free from harm.” Articulating a vision is a necessary first
step, but establishing the vision requires more deliberate action from leaders. To start, leaders must
deeply understand and clearly communicate the current state of patient safety in the organization.
This step might be a serious challenge in organizations that have denied or ignored their specific
safety issues. But articulating an ambitious vision without an honest reckoning with the current
environment will be seen as inauthentic. Leaders also need to model their vision in everything that
they say and do. There is a fine line between holding people accountable for unprofessional conduct
and not punishing people for human mistakes, yet leaders need to always be on the right side of that
line.

Building trust (as well as respect and inclusion) is crucial to a culture of safety. A key lesson learned
by leaders in aviation who worked to improve air travel safety was that rigid hierarchy is itself a
safety risk. The culture of the cockpit was as essential to safety as the preflight checklist. Trust,
inclusion, and mutual respect between pilot, copilot, and crew were necessary for effective and
timely communication in a crisis. The same is true in health care. Regardless of role or position,
members of the care team must feel comfortable and empowered to speak up when they observe a
safety risk.

Boards of health care organizations are ultimately responsible for the safety and quality of the care
provided. But it is the responsibility of leaders to work with their boards to ensure systematic and
actionable review of key elements of safety. Some best practices in this area include ensuring that
reviewing safety performance is a standing agenda item for all board meetings, bringing the patient
voice to board meetings, educating the board to ensure that a lack of clinical knowledge doesn’t
preclude effective governance of safety, and adding safety experts from other industries to the
board.28

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Leading a culture of safety also requires establishing an overall culture in the organization that
balances accountability and support. Such a culture is known as a just culture, which AHRQ
describes as one that:

“ …recognizes that individual practitioners should not be held


accountable for system failings over which they have no control.
A just culture also recognizes many individual or "active" errors
represent predictable interactions between human operators and
the systems in which they work. However, in contrast to a culture
that touts "no blame" as its governing principle, a just culture does
not tolerate conscious disregard of clear risks to patients or gross
misconduct (e.g., falsifying a record, performing professional duties
while intoxicated).29"

A just culture must inform every action and decision. Rewarding examples of these principles needs
to be as common, if not more so, than punishing examples of nonadherence.

Leading a culture of safety requires ensuring that not only the compelling vision, but also the
mission and values, are represented in every action by every individual in the organization. Key
behavioral expectations within a culture of safety include teamwork, true two-way communication,
respect, and transparency. Just as leaders need to clearly understand the gap between the
compelling vision and the current state, they also need to understand the gap between the
expectations for behavior and the actual behavior in the organization. Holding people accountable
when they violate these expectations is key, as is modeling the behaviors expected.

Learning from Learning


While a culture of safety is critically important, culture alone is not sufficient. In order to achieve
the goal of zero harm, a culture of safety must be complemented by an effective learning system to
harness, refine, and deploy all of the knowledge flowing through the organization.

This marriage of culture and learning forms the basis for an approach, developed by IHI and Safe &
Reliable Healthcare in 2017, to making care safer, more reliable, and more effective (Figure 3).30

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Four Domains of Transparency
Transparency between clinicians and patients (illustrated by disclosure after medical errors)
Transparency among clinicians themselves (illustrated by peer review and other mechanisms to share information with health care
delivery organizations)
Transparency of health care organizations with one another (illustrated by regional or national collaboratives)
Transparency of both clinicians and organizations with the public (illustrated by public reporting of quality and safety data)
Source: Reprinted with permission from the IHI Lucian Leape Institute. Shining a Light: Safer Health Care Through Transparency. Boston,
MA: IHI; 2015.

FIGURE 3

Leadership is as essential to the learning system as it is to create and sustain a culture of safety.
Leaders need to steward the learning system by modeling all of the behaviors inherent in all
components of the learning system (i.e., transparency, reliability, improvement and measurement,
and continuous learning). And leaders need to create the expectation, at every level of the
organization, that everyone has a key role to play.

Learning can’t happen in the dark; it all starts with transparency. In health care, an effective
learning system requires full and open transparency at four levels: among clinicians, with patients,
among organizations, and with the community (Table 1).31

One simple but powerful way to demonstrate and leverage transparency with patients and among
clinicians is through the use of visual learning boards (also called visual management boards).
These clear displays of information are a hallmark of many approaches to improvement. Recent

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work by IHI and its partners in Scotland to implement a High-Performance Management System
as a means to reduce costs and improve quality used these kinds of visual boards to great effect.32
Usingbox scores (concise dashboards of performance in key measures), teams updated themselves
and their colleagues in nearly real time on the data generated by various tests of change. Huddling
around these dashboards at regular times became part of daily, standard work. This seemingly
small change helped to improve culture (as indicated by staff reports of improved teamwork and
satisfaction) and achieve the aims of lower costs and better quality.

“ A just culture must inform every action and decision. Rewarding


examples of these principles needs to be as common, if not more so,
than punishing examples of nonadherence."

Transparency is, of course, more than visual learning displays. It’s a core value that drives decisions
and actions every day. It’s a mindset that ensures that failures are addressed by improving systems,
not by punishing individuals.

As noted, part of the appeal of focusing on zero harm is that it compels leaders to understand and
apply the principles of high reliability in the organizations they lead. Ensuring reliability rests on
the capacity of the learning system to support four foundational principles: (1) standardization,
(2) simplification, (3) reducing autonomy, and (4) highlighting deviation from practice. All four of
these principles face unique challenges in health care. Standardization is a challenge because each
patient is different, each clinician is different, and each interaction between patient and clinician
is different. Simplification is a challenge because of the complexity of the individuals involved
(physical, psychological, and socioeconomic) and the complexity of health systems in general. And
the final two principles — reducing autonomy and highlighting deviation from practice — run right
up against traditional elements of health care culture such as physician autonomy and medicine
practiced as much as art as science. These challenges must be overcome to achieve reliability, a
culture of safety, and zero harm.

A learning system can fulfill the function of detecting and evaluating reliability at a given moment,
but in order to truly support the principles of reliability, a learning system also needs to leverage the
tools of improvement. These tools allow people in the system to develop, test, refine, implement,
and spread the changes needed to achieve reliable outcomes. There are several methods of
improvement — for example, Lean, Six Sigma, high reliability organization (HRO) theory, and the
Model for Improvement. Regardless of which method is used by an organization, it’s essential to
train and capacitate leaders and staff to optimally use its tools.

All improvement methods rely on effective measurement. Leaders and staff need to understand
which data to collect, when and how to collect them, how to display them, and, of course, how to
interpret them and act on the insights that they convey. The Model for Improvement, which IHI
has used for decades, emphasizes the interdependent importance of three types of measures: (1)
process measures, (2) outcome measures, and (3) balancing measures (Table 2).

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Process Measure Outcome Measure Balancing Measure
Percent of patients assessed for risk of Percent of patients with blood clots Percent of patients who experienced
developing a blood clot bleeding due to aggressive use of anti-clot
medication
Percent of patients who received pneumo- Incidence of pneumococcal pneumonia Percent of patients receiving the pneumo-
coccal pneumonia vaccine coccal pneumonia vaccine who experi-
enced an allergic reaction to the vaccine
Source: Reprinted with permission from A Framework for Safe, Reliable, and Effective Care. IHI and Safe & Reliable Healthcare; 2017.

Deciding which metrics to collect and track over time is a foundational step in any improvement
effort. Effective measurement also relies on facilitating the timely collection of appropriate data.
Leaders should work to integrate data collection into standard workflows and should make it a well-
understood responsibility for staff at all levels. Proper display of data in run charts and statistical
process control charts ties back to transparency as a crucial element of an optimal learning system.

These elements of a learning system — leadership, transparency, reliability, improvement,


and measurement — all combine to generate the ultimate goal of an optimal learning system:
continuous learning leveraged for continuous improvement. Some safety problems in health care
may well be solved quickly and completely, but reducing and removing the intractable safety risks
and getting to zero harm will require a comprehensive learning system.

An example of a key process in learning systems is root cause analysis (RCA), which has been
used for decades across many industries, as a structured way to understand the ultimate causes of
undesirable events. RCA can be a valuable source of knowledge, but that knowledge is wasted if it’s
not fed back into the learning system and used to change practice and design and dictate actions
that can prevent similar events from occurring again. Recognizing this essential role of a learning
system, the NPSF developed a tool named RCA2 (Root Cause Analysis and Action) to support its
bold goal of a health care systemfree from harm. RCAsquared goes beyond traditional RCAs by
probing thewhat and thewhy while also determining actions (thehow) that can be implemented,
measured, and refined to ensure the prevention of future harm. Determining the strength and
effectiveness of actions is a key component, as is feedback to involved staff and patients. RCA2
accords with other key principles of safety improvement such as focusing on systems-based
issues and not on individual performance. Successful use of the RCA2 tools also relies on effective
leadership (attention, modeling, accountability) and buy-in at all levels of the organization.33

“ This shift from reactivity to proactivity is essential to all aspects


of a total systems approach to safety, from intrinsic motivation to
culture."

Just as RCA2 aims to identify and implement actions that can reduce safety risks in the future, a
crucial goal of an optimal learning system in health care is to generate proactive approaches to
prevent harm. For years, those in the patient safety field have worked hard to improve how health
care responds to serious safety failures. The scholarship that has been produced, and the processes
that have been enacted, have helped countless organizations to respond properly when things go
wrong. But to get to a future free from harm, organizations need to augment appropriate responses

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to adverse events with knowledge and processes designed to prevent them. This shift from
reactivity to proactivity is essential to all aspects of a total systems approach to safety, from intrinsic
motivation to culture.

Moving toward greater proactivity is aided by another necessary change: learning from positive
outcomes as well as negative ones. Learning from defects or failures will always be an important
part of any optimal learning system, but learning from positive outcomes — e.g., successful
prevention of harm — also needs emphasis. Erik Hollnagel and his colleagues call this shift moving
from “Safety I” to “Safety II.”34 Specifically, they believe that accelerating improvements in safety
requires combining the more traditional inquiries into why something went wrong with equally
rigorous inquiries into why, much more often than not, things go right. For leaders, highlighting
and celebrating successes, includingpositive deviations from standard practice, is an effective way
to model a just culture of safety, amplify agency and motivation, and generate learning that can be
translated into action.

An effective learning system harnesses and deploys the knowledge that is generated within an
organization. Anoptimal learning system goes further and incorporates knowledge from outside an
organization, often in the form of a network. Networked learning highlights the importance of the
latter two domains of transparency needed in an optimal learning system: (1) transparency among
organizations and (2) transparency with the community (see Table 1).31

Improving at scale is aided by learning from large networks. IHI’s campaigns as well as other
national safety initiatives in the U.K. and the U.S. have relied on collective and collaborative
learning.35Children’s Hospitals’ Solutions for Patient Safety (SPS) is just one example of how
transparent, collaborative learning can lead to broader improvement and greater impact. This
network originated within the six-member Ohio Children’s Hospital Association and has since
grown into an international collaborative. Further success and expansion relied on using the
standard tools of improvement and transparently learning from the best-performing organizations.
Leaders leveraged bold goals and meaningful results (i.e., significant reductions in serious safety
events and serious harm events) to grow the initiative into a national network. Currently, SPS
engages more than 135 children’s hospitals in the U.S. and Canada. Leaders of the initiative are
focusing on cementing high reliability into organizational culture as well as on fostering effective
patient and family engagement as core strategies for continued improvements.36, 37

Opportunities to engage in large collaboratives and learning networks are proliferating. Premier
Inc., a former strategic partner of IHI, runs several national collaboratives. ImproveCareNow, a
network focused on improving care and outcomes for children with inflammatory bowel diseases,
has engaged 109 care centers across 39 states (and three other countries), comprising 950
gastroenterologists caring for more than 30,000 children. These collaborative efforts, along with
IHI’s campaigns, CMS’s Partnership for Patients, and networks such as Solutions for Patient Safety,
have demonstrated that large-scale change is possible. Collective learning across organizations
accelerates improvement and helps to sustain the gains. Leaders of organizations and systems
should make participation in these networks an ongoing priority.

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Regression is the stubborn and common foe of any successful
improvement effort."

Regression is the stubborn and common foe of any successful improvement effort. There are
countless examples of real, breakthrough improvements in processes and outcomes that aren’t
sustained once attention and resources are directed elsewhere. Ensuring sustainability relies on
many of the methods and principles described above, especially reliability. In fact, one way to
define sustainability is reliability over time. The use of visual management boards displaying key
data is one method for ensuring sustainability. If the use of these displays lasts only as long as an
improvement initiative, then regression could occur without anyone knowing about it. Using these
boards in perpetuity is one way to ensure transparency of safety and quality, and full transparency
of results is crucial to sustainability. The bold goal ofgetting to zero is another means of ensuring
sustainability. The simplicity of the goal and the transparent reporting of all instances of harm
will focus people on the need to keep up their efforts and continue to pay attention to all of the
processes and actions needed to ensure zero harm.

Learning systems contribute to every element of a systems-based approach to preventing harm.


They help to create highly reliable processes. They help optimize workflows so doing the right thing
is easy and standard. And they change culture, ensuring that improving safety isn’t some add-on
but instead is a genuine change in how things are routinely done. Today, surgeons can’t imagine
starting an operation without the standard surgical timeout. That wasn’t the case even 20 years
ago. The collection of data, the interpretation of those data, and the translation of those data into
specific actions were the necessary steps that made such change possible.

Engaging Patients: Nothing About Me Without Me


Combining a culture of safety with an optimal learning system isn’t enough to prevent harm.
Getting to zero harm requires engaging and leveraging all available assets, and patients and
families are invaluable assets in this regard. Assets may not be the best description of the role that
patients and their families must play in ensuring safety. They must be engaged as true partners in
care, in care redesign, and in the governance of safety and quality.

In 2012 and 2013, the Lucian Leape Institute convened experts from patient advocacy
organizations, professional organizations, health systems, patient safety research organizations,
and international safety organizations. Their deliberations and discussions (which began with
personal stories of instances of harm suffered by them or people close to them) produced a set of
recommendations aimed at four levels of stakeholders: (1) leaders, (2) clinicians and staff, (3) policy
makers, and (4) patients, families, and the public.38

For leaders, effective partnership with patients and families begins with making patient and family
engagement a core value. As with safety in general, prioritizing engagement isn’t enough; it needs
to become central to the way things are done in a health system. Leaders are also responsible
for ensuring that patients and families are equal partners in care design and care improvement.
Educating and training everyone who works in a health system on how best to partner with

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patients and families is an ideal way to demonstrate that this engagement is a core value for the
organization. Leaders also need to get beyond the walls of their organization or system and engage
the public through patient advocacy groups and other community-based organizations.

Frontline clinicians and staff share the responsibility to partner with patients and families in
improvement and care redesign. As the direct interface with patients and families, clinicians and
staff also have the responsibility to provide the information, resources, and tools that will ensure
and aid engagement. And when things go wrong, it is incumbent on clinicians to be the first ones to
transparently provide information, effective apology, and support to patients and families.

At the policy level, engaging patients and families to improve safety means ensuring that those
stakeholders have key roles in policy-making committees. Policy makers also need to focus on
developing and tracking important metrics related to safety. Setting the research agenda for
patient safety improvement is another area in which policy makers need to partner with patients
and families to ensure that their unique perspectives and experiences are factored into academic
exploration.

Patients and families need to be partners in their own care, but they cannot and should not assume
primary responsibility for safe care; that responsibility lies with the health care system. Health
professionals are responsible for communicating the risks to safety and for providing the guidance
and tools that patients and families need for safe care. Best practices for patients and their families
include always asking questions about the risks and benefits of the agreed-upon care plan; bringing
a family member, friend, or other advocate to hospital or doctor visits; knowing how and why they
take their medications (and the names of the medications); using teach back to repeat in their own
words what they’re hearing from their care team; and being certain about who is in charge of the
care plan and exactly what that care plan involves.

“ Patients and families need to be partners in their own care, but they
cannot and should not assume primary responsibility for safe care;
that responsibility lies with the health care system."

Effectively engaging patients and families in getting to zero harm rests on the reality that patients
and families are members of the care team and are every bit as important as the clinicians
themselves. This reality means that the same principles needed for effective collaboration among
clinicians — psychological safety, transparency, engagement in improvement and measurement,
and a focus on reliability — are required for partnering with patients.

There isn’t a single model for effective patient and family engagement; engagement can and
does take many forms. Shared decision-making, in which clinicians and patients/families arrive
at key care recommendations collaboratively, is becoming more and more common. In that
model, clinicians bring the latest evidence and information; patients and families bring their
own preferences, values, and circumstances; and together they arrive at key decisions. Codesign
of care plans is an expanded version of the shared decision-making idea, with the entire care

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pathway arrived at collaboratively and with the patient’s expressed goals and wishes as the
primary drivers. Root Cause Analysis (or, better yet, RCA2) also benefits from engaging patients
and families. Traditional RCA usually omits the crucial perspective of the patient, who is the only
person who fully observes the entire event from start to finish, including both the antecedents to
and consequences of the event. Patient and Family Advisory Committees are another common
method of directly engaging patients and families. These committees give agency and aseat at the
table to patients and families when a health system is making important decisions. Lastly, involving
patients in the governance of safety in health systems is an increasingly common and effective
method of engagement. Such involvement can be accomplished by creating new board committees
that engage patients or by having patients join the board as trustees. Some forward-thinking
boards of health care organizations make it a custom to start every board meeting with a patient
story. The only wrong way to approach engagement is to shift any of the responsibility for safe and
high-quality care from the health system onto patients and families. As long as that type of shift is
scrupulously avoided, engaging patients and families as partners in their care can take nearly any
form. The key point is that more engagement is needed if eliminating harm is going to become a
reality.

Chasing Zero
Improving patient safety has been a daunting challenge since the curtain was pulled back to reveal
the true risks posed by health care more than 30 years ago. Achieving the goal of zero harm to
patients, families, and the health care workforce is a mammoth undertaking. It will take nothing
less than a comprehensive, systems-focused approach.

The first step, unfortunately, makes the rest more challenging. The definition of harm needs to be
broadened. Emotional, psychological, and sociobehavioral harm is as real, as impactful, and as
preventable as physical harm. Additionally, the imperative to improve safety does not apply only to
patients. The health care workforce, as well as family and friends serving as essential caregivers,
are at risk for physical and psychological harm. Ensuring safety for these indispensable people is a
necessary precondition for ensuring patient safety.

A comprehensive, systems-focused approach to improving safety requires four interdependent


elements: (1) effectively managing change by tending to the psychology of change; (2) creating
and sustaining aculture of safety; (3) developing and leveraging an optimallearning system; and
(4)engaging patients in the codesign of care and improvement.

Perhaps for the first time, health care has both the evidence and the learning — accumulated over
decades of hard work and study — to make zero harm a reality. Leaders in health care have a duty to
use this knowledge to transform their systems and to make care truly and completely safe for all.

Tejal K. Gandhi, MD, MPH, CPPS


Former Chief Clinical and Safety Officer, Institute for Healthcare Improvement

Derek Feeley,
President and CEO, Institute for Healthcare Improvement

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Dan Schummers,
Chief of Staff, Institute for Healthcare Improvement

Disclosures: Tejal Gandhi is Chief Safety and Transformation Officer at Press Ganey Associates LLC. Dan
Schummers has nothing to disclose. Derek Feeley has nothing to disclose.

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NEJM Catalyst is produced by NEJM Group, a division of the Massachusetts Medical Society.
Downloaded from catalyst.nejm.org at UNIVERSITY OF TEXAS AT AUSTIN on February 19, 2020. For personal use only.
No other uses without permission. Copyright © 2020 Massachusetts Medical Society. All rights reserved.

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