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Zero Harm in Health Care - Catalyst PDF
Zero Harm in Health Care - Catalyst PDF
“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
NEJM Catalyst is produced by NEJM Group, a division of the Massachusetts Medical Society.
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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.
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
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
FIGURE 2
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.
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.
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.
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.
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.
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
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
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:
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?”
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
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
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.
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
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
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).
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.
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
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
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.
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.
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
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
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.
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.
Derek Feeley,
President and CEO, 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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