Now the Hard Part: Creating a Culture of Safety

Abstract

In 2020, the coronavirus pandemic killed 1,800,000 people, 346,000 of them Americans. In that same year, if recent estimates are correct, about the same number died as a result of medical errors, all despite the enormous effort of the past 20 years to eliminate preventable harm, an effort that has involved people at all levels: policy makers, government agencies, oversight bodies, quality improvement organizations, major health-care systems, and thousands of providers and caregivers on the frontline.

In 2020, the coronavirus pandemic killed 1,800,000 people, 346,000 of them Americans. In that same year, if recent estimates are correct, about the same number died as a result of medical errors, all despite the enormous effort of the past 20 years to eliminate preventable harm , an effort that has involved people at all levels: policy makers, government agencies, oversight bodies, quality improvement organizations, major health-care systems, and thousands of providers and caregivers on the frontline.

Many injuries have been prevented, and thousands of lives have been saved. Fewer people suffer from hospital-acquired infections and medication errors , surgical complications, and falls in the hospital. But the overall number of preventable injuries has hardly budged. The relentless advances in medical science and the constantly changing demands of the environments in which we deliver care create new opportunities for harm faster than we can keep up.

We have learned a great deal. Driven by the concept that the cause of errors and unintended harm is not bad people, but bad systems , we have been engaged in an immense experiment testing myriad ways to make those systems changes. It has truly been a paradigm shift. Early efforts focused on changing processes at the level of the care unit or hospital. These were initially ad hoc responses to local problems, but with time an impressive repertoire has been developed of standardized practices of proven effectiveness that can be widely adopted (see Chap. 11).

Several large systems, such as the Veterans Health Administration , Ascension , Kaiser-Permanente , and others, expanded the use of these proven practices to all of their hospitals and clinics. Collaboratives have been developed that brought together quality improvement teams from a region or nationally to work together to implement a practice. Some of these were spectacularly successful, virtually eliminating a major threat in those hospitals [1].

Despite these impressive successes, the painful fact is that with few exceptions (such as two-factor identification of patients, barcoding of medications, and perhaps hand hygiene), most of this awesome array of standardized effective practices has not been adopted by the majority of providers and health-care organizations. Health care is still stunningly unsafe.

But even if the adoption problem could be solved, relying on universal implementation of specific practices is not likely to be an effective strategy for achieving safe health care. The potential number required must be in the thousands, and the complexities of health care ensure that new hazards will constantly arise for which there are no known practices.

If the experience of other industries that have succeeded in becoming safe is a guide, it will require much more than changing our practices to prevent specific harms . It will require changing our culture . A change that was called for in the earliest writings on patient safety [2] and in the legendary IOM report [3].

What are we talking about? What is culture , and what is the culture change that is required?

What Is Culture ?

The word culture has been used, abused, and misused a great deal in the health-care literature. A major disagreement, especially in the UK, centers on whether the culture of a group should be defined in terms of its attitudes, assumptions, values, and beliefs or in terms of its actions, “how we do things around here.” Is culture who we are or what we do? I believe the evidence is clear that it is both – and that each determines the other, which is the point of this chapter.

For example, from time immemorial, a well-established espoused value and assumption about physician behavior was that the physician had the sole authority to make treatment decisions, irrespective of external guidelines or internal contrary advice. The result – the practice – was deference to their authority. When that practice has been changed, when a hospital adopts adherence to standards as a condition of practice, not only does the “way we do things” change, so do, gradually, the attitudes and the values of the culture overall.

In anthropology, culture refers to social behavior in different societies or the knowledge, beliefs, and customs of their members expressed in their traditions, mythology, or religion. Nation-states pride themselves on their cultures , their traditions, their “solidarity” (or lack of it), and their particular religious commitment. We also speak of culture as a term of human refinement to differentiate elite from others.

Within societies we speak of the culture of subgroups, such as the military, medicine, “hippies,” or the culture of a firm such as IBM or Apple. We note regional cultures such as those of the South or Midwest. In all these contexts, culture reflects the deep shared values and assumptions that guide us in what we should and should not do. Those values are expressed in behavior, “how we do things around here.”

When we think of “how we do things around here” in health care, the focus is not just on patient care and the provider-patient interface but also includes the relationships and interactions of all who work in the care delivery setting. Individual medical specialties, nursing, pharmacy, etc. have strong subcultures, but it is predominantly the organizational culture of the hospital or clinic that determines how patients are cared for.

Most of what we know about organizational culture comes from studies of other industries. The work of Edgar Schein is preeminent [4]. Schein notes that three elements define an organization’s culture: its shared assumptions; its espoused values, i.e., what a group ideally wants to be and wishes to present itself to the public; and the day-to-day behaviors. Culture includes everything we do in an organization; it makes sense of what we do, it provides stability.

The shared assumptions run deep. They are the “truth” as perceived by the organization’s members: their beliefs about human nature, such as whether people are intrinsically self-motivated or motivated by money, their perceptions of reality, and their concept of mission. In health care, shared assumptions include a commitment to responding to emergencies and putting the patient’s interest first. They are the unwritten rules.

Edgar Schein. (All rights reserved)

Espoused values include such things as individualism, respect for authority, and working hard. Behaviors are the visible manifestations of the culture , the rituals and how we treat one another, labelled by Schein as “artifacts” [4]. Others have used the term safety climate to refer to these expressions of the culture .

Schein summarizes this in a definition of culture that is widely accepted as capturing the essential aspects: “A pattern of shared basic assumptions that was learned by a group as it solved its problems of external adaptation and internal integration, that has worked well enough to be considered valid and, therefore, to be taught to new members as the correct way to perceive, think, and feel in relation to those problems” [4].

In large organizations such as hospitals, the individual units, services, and divisions also have their own cultures . These subcultures share some of the organization’s values and assumptions, but not necessarily all, with the result that members of one unit may engage in behaviors that differ substantially from those in another. For example, when a nurse makes an error , whether the unit’s nursing culture is supportive or blaming affects whether they will report the error so it becomes known and can be investigated. The culture in the ICU may be very different from that in the emergency room or from another ICU down the hall.

A Culture of Safety

What is a culture of safety ? The term was first used by the International Nuclear Safety Advisory Group report following the 1986 disaster at the Chernobyl Nuclear Power Plant, the cause of which was attributed to a breakdown in the organization’s safety culture [5, 6].

A useful definition was later put forth by the UK Health and Safety Commission:

The safety culture of an organization is the product of the individual and group values, attitudes, competencies and patterns of behavior that determine the commitment to, and the style and proficiency of, an organization’s health and safety programs. Organizations with a positive safety culture are characterized by communications founded on mutual trust , by shared perceptions of the importance of safety, and by confidence in the efficacy of preventive measures [7].

One of the earliest and most respected students of organizational culture , James Reason, of the University of Manchester, UK, identified five components that characterize a culture of safety [8]. It must be:

• An informed culture : It needs data about incidents and near misses.

• A reporting culture : Workers must feel it is safe to report and that it makes a difference.

• A just culture : People are rewarded for providing essential safety information, but deliberate breaking of the rules is not tolerated.

• A flexible culture : The organization can reconfigure itself in response to a new danger, such as moving from hierarchical structure to a flattened structure as needed.

• A learning culture : It is able to draw the right conclusions from its information system and has the will to implement major reforms when needed.

One follows from another. An informed culture can only be built on the foundations of a reporting culture . This, in turn, depends upon establishing a just culture . Flexibility and learning are only possible if the other components are established. But none of this is possible without openness and trust .

As Schein points out, a culture of safety can only exist within the broader culture of a health-care organization that is committed to providing patients with the experience of high-quality effective care, delivered efficiently by valued and engaged workers. While in other industries the safety focus is on workers, in health care it is primarily on the patient, but to succeed it must also include worker safety.

Characteristics of a Safe Culture

Unfortunately, few health-care organizations have seriously striven to become a safe culture. What should it look like? What are the characteristics of a safe culture in health care?

At the organizational level, in a culture of safety everyone shares a commitment to the goal of zero harm and to the continuing improvement and innovation that are required to get there – to the belief that anything is possible. There is a sense of individual responsibility at every level, that safety is everyone’s job. Leaders exemplify these commitments and motivate others to share them. Their sincerity of purpose, consistency, and transparency inspire trust .

The individual is valued, and every voice is heard. Leaders seek to follow the advice of Paul O’Neill , the highly successful CEO of Alcoa , who taught that every worker, every day, should come to work feeling they are respected regardless of rank or expertise, supported to do their work well, and appreciated for what they contribute.

At the operational level, in a culture of safety people work in teams and are open and trusting of one another. They share the mission of providing care that is free of harm . There is a commitment to standard work , i.e., finding the best way to do something and everyone doing it, yet they are open to changing it to make it better. Innovation and improvement are part of everyday work and are everyone’s responsibility. They give meaning to work. Patients are fully engaged as partners in their care and in improvement.

At the individual level, in a safe culture, workers feel valued and supported. Their deep sense of individual responsibility for safety is expressed not only by being careful but by being alert and looking for hazards, “accidents waiting to happen.” Errors , harms , near misses, and hazards are promptly reported because they know they will be taken seriously, promptly investigated, and acted upon.

A culture of safety is a learning culture . It is an environment where everyone is aware of how far their work falls short of what it could be and is committed to improve. A learning culture is characterized by its members’ ability to self-reflect and identify strengths and defects [9]. People pay attention, notice problems, and reflect on them. Problems are analyzed, and solutions are imagined and created. Changes are implemented.

Schein emphasizes that a learning culture is based on positive assumptions about human nature: that human nature is good and that people will learn if it is psychologically safe to do so. There is commitment to learning to learn, to truth as discovered by inquiry, to full and open communication, to systems thinking [4]. A learning culture is based on trust , transparency , and reliability.

A Just Culture

A culture of safety is also a fair and just culture. What does this mean? From the beginning, the fundamental aim of the patient safety movement has been to shift the focus from the individual to the system when things go wrong. Some (not your author) have referred to this as a “no-blame” approach. For the vast majority of iatrogenic harms , probably 90% or more, this is appropriate. The harm was unintentional and resulted from poor system design . The caregiver is truly the “second victim.”

But some errors and some injuries are caused by intentional acts. For these a no-blame approach is inappropriate.

If the individual intended to cause harm , the act is assault and should be dealt with by the legal system. Fortunately, assault is exceedingly rare in health care (serial murders, etc.). The much more common intentional act is rule breaking in which the caregiver does not intend harm , but deliberately fails to follow a standard procedure.

This form of violation is actually quite common. Because of time and workload pressures, nurses and doctors often “cut corners” to get their patients taken care of, especially if the rule doesn’t make sense, doesn’t seem to apply in this case, or prevents them from getting their work done. But even if the act seemed justified, the caregiver will feel ashamed if it harms the patient because they will realize they have “done something wrong.”

These cases should be carefully investigated. If the broken rule is a bad rule, or unworkable, it should be changed, by a process that involves all stakeholders . If the existing rule is good and necessary, education may be necessary; if time pressures or workloads are the issue, these should be addressed. On the other hand, if a violation results just from the caregiver’s personal preference or convenience, discipline may be indicated, especially if there is a pattern of such behavior.

Seeing that indefensible repeated violations have consequences is important for co-workers in two ways. They see that justice is done – the person didn’t “get away with it” – and it reinforces their own rule-abiding behavior. A just culture is the necessary balance to a systems approach [8, 10].

The term safety culture is sometimes confused with safety climate , which is its outward manifestation – its visible evidence, or “artifacts” as Schein puts it. Safety climate more appropriately refers to the perception of the culture , what people think about themselves and “what we do around here.” It is what we measure when we attempt to measure safety culture [11].

High-Reliability Organizations

Much has been written about high-reliability organizations (HRO) and whether they are the model for a safe culture. The concept is based on a series of studies in the early 1990s by Roberts and colleagues of highly hazardous industries, such as aviation and nuclear power, that had succeeded in becoming extremely safe [12]. While it is true that, unlike health care, these industries had strong business cases for safety – they would be out of business if unsafe – the fact is that they are amazingly successful.

Weick and Sutcliffe identified five characteristics that account for the success of HRO , which they label collective mindfulness : (1) preoccupation with failure, the continual looking for and reporting of hazards; (2) reluctance to simplify, not accepting the obvious explanation for a failure; (3) sensitivity to operations, paying attention to issues at the frontline; (4) commitment to resilience, the ability to detect errors, react, and recover; and (5) deference to expertise, the flattening of the hierarchy in an emergency so that the most qualified person is in charge, regardless of seniority [13].

Collective mindfulness leads to the essential behavior for safety, which is that everyone understands that even small failures can lead to catastrophic outcomes and accepts responsibility both for identifying hazards early and for correcting them before harm occurs [13].

In other industries, HROs have achieved a culture of safety and enviable outcomes. The idea of applying these principles to health care is attractive [14]. Certainly these characteristics of structure, attitude, and expertise need to be part of the changes in quality of care and experience that make health care safe.

The originator of the concept of HROs , Karlene Roberts , also attributes much of their success to the emphasis on relational aspects of the culture : interpersonal responsibility, person-centeredness, being supportive of co-workers, friendliness, openness in personal relations, creativity, credibility, interpersonal trust , and resiliency [12, 15].

The Problem

Most health-care organizations fall woefully short of achieving a culture of safety . With just a few exceptions, hospitals and health-care systems, including some of the most highly regarded academic health centers, have settled for implementing some safe practices ; the culture is unchanged.

In a safe culture, there is a strong commitment to the goal of zero harm and to the continuing improvement and innovation that is required to get there. In health care, safety is too often an afterthought or at best a distant second fiddle to the bottom line. There is no sense of commitment, no goal of zero harm . Deliberate unsafe care is often tolerated, especially among big earners.

In a safe culture, safety information systems collect data on incidents and near misses. Reporting of adverse events or hazards is encouraged and leads to investigation, analysis, and, where possible, redesign of a process or system to eliminate the risk. In health care, many institutions have established reporting system and a process for root cause analysis of events to meet accreditation requirements, but their use is often perfunctory. Now 25 years after hospitals were urged to stop blaming people for errors , nearly half of nurses surveyed by the Joint Commission say they do not report errors because of fear that they or a colleague will be punished.

In a safe culture, workers feel valued, supported, and empowered. They have a sense of ownership, of responsibility, to prevent harm and work well in teams . Sadly, in health care this sense of responsibility and empowerment has long been inhibited by a hierarchical system that devalues their contributions and makes working in teams difficult. It is a culture of low expectations and low accountability .

Why Changing Culture Is so Hard to Do

Creating a safe culture is the key part of the transformation that a health-care organization must undergo overall to reliably provide a patient experience of high-quality, effective, and efficient care. Under the best of circumstances, these are difficult changes to carry off, but health care also offers a staggering array of barriers to change.

The first has been resistance by the key members of the workforce: physicians. Products of an educational system that traditionally emphasized personal responsibility for patient care, many viewed standardization as a threat to their independence and personal judgment. Giving up control and sharing responsibility by working in teams were hard to do.

Fortunately, that has begun to change. Younger physicians have learned the importance of quality improvement and are amenable to working in teams . They “get it” and now constitute a significant majority of physicians.

The second major barrier to change is an incredibly complicated demand/incentive payment system that compels hospitals – i.e., doctors and nurses – to document that they meet quality and volume requirements. The result is an extensive, and, for caregivers , depressing, set of demands on their time that compete directly with their primary mission of taking care of patients.

This oppressive payment system is the product of two forces that changed dramatically in the past several decades: the ability to measure safety and quality and the rising cost of care.

Twenty years ago, as the quality and safety movement was gaining steam, many complained about the paucity of good measures . For safety, what were the errors and systems failures we should focus on? For quality, the IOM called for care that was safe, efficient, timely, patient-centered, efficient, and equitable [16]. But, again, how would we know? Well, in the past 20 years we’ve developed methods for measuring all of these. More are needed, but thanks to an impressive effort by quality and safety researchers we can now measure quite a bit.

The other major driver of demand/incentive payment changes is costs , which have risen dramatically since the middle of the twentieth century primarily as the result of awesome improvements in diagnosis and treatment that have been heavily weighted toward expensive technologies. Magnetic resonance imaging, PET scans, and surgical robots, for example, cost health care millions of dollars a year. A new “miracle” drug may cost hundreds of thousands of dollars a year for a single patient.

Facing the need to contain costs , payers and regulators seized on available measures to assess performance and used them for accreditation and for value-based financial incentives. Lowered reimbursement rates force physicians to see more patients (production pressure) .

A particularly painful example for physicians resulted from the generous incentives provided by the government for adoption of the electronic health record (EHR) . When computerized records were being developed, many of us were enthusiastic about their potential to improve the quality of care, such as by reducing medication errors and making standardized clinical information available. A number of private companies rose to the opportunity, each with its own product, most of them built around systems they already had for billing and financial management. Not only were these clumsy, inefficient, and non-user-friendly, they were proprietary and thus would not communicate with one another.

Finally, the government stepped in—not to regulate and standardize systems as many of us had hoped, but to promote their use through a massive subsidy for the implementation of these mostly proprietary systems by hospitals and physicians. Because most of these EHRs are poorly designed, the result has been a huge increase in the time that physicians must spend in documentation.

The resulting burdens of using the EHR , increased production pressure , and loss of control are widely considered to be major factors in the dissatisfaction and burnout that has become increasingly common among health workers. We have created an environment where many nurses, doctors, and allied health staff are too exhausted, too disillusioned, and too burned out to have the interest or the energy to engage in efforts to change. There is little time for reflection, improvement, or preventing errors.

In addition to physician resistance and perverse payment incentives, a third barrier to creating a culture of safety stems from financial threats to institutional survival. In our predominantly fee-for-service system, economic survival of a hospital depends on the number of services provided and how much they are paid for them. To control costs , government payments—Medicare and Medicaid—are below market for virtually all services. Commercial insurance companies pay much better—sometimes multiples of Medicare reimbursement. They also negotiate rates with hospitals.

In this system, large hospitals increase their income by attracting more patients through providing ever more sophisticated and expensive treatments. Although they have many Medicare patients, large hospitals receive the major share of their income from commercial insurers with whom they negotiate rates.

Smaller hospitals lose on both counts. They are unable to attract more patients with increased services, and they lack the clout to negotiate higher rates with insurance companies. Safety net hospitals, formerly city hospitals for the indigent, and rural hospitals fare even worse. They depend almost totally on local government support and Medicaid, both at “bare-bones” levels.

In all hospitals, the CEO is under constant financial pressure—beholden to “the bottom line.” The large expensive hospitals, like other corporations, vie for increased market share by providing additional services. If they become the dominant provider in a region, they can exercise monopoly power and can raise their prices. While technically “not for profit,” they generate large profits, which they use to expand their services and to increase the pay of their physicians and, especially, their CEOs . According to Forbes, in 2019 the top 13 nonprofit hospitals and systems paid their CEOS between $five million and $21.6 million; the next 61 paid CEOs between $1 and five million [17].

The fourth barrier to changing culture, compounding all the others, is the incredibly complex nature of health care. No other industry comes close. The client—the patient—may suffer from an almost infinite number and variety of diseases. In addition, patients also vary widely in what they bring to the therapeutic encounter in terms of genetic makeup, physical and mental health, and the effect of the living environment where they receive most of their care.

Matching the number and variety of diseases is an incredible number and variety of treatments, using modalities as varied as chemicals (drugs), electromagnetic waves, surgery, robots, and computers. Compounding this is a lack of standardization of use. Each form of treatment can be—and often is—employed according to the judgment, or whim, of the provider. The result is an almost infinite number of ways things can go wrong [18].

Finally, those who provide care are a diverse group. In addition to doctors, nurses, and pharmacists , many other workers, such as therapists, aides, clerical staff, and support staff, are essential personnel who make a hospital work. There are 180 specialties and subspecialties in medicine alone, each with its unique knowledge, skills, and approach to patient care.

The complexity of health care and the formidable array of regulatory and financial forces impacting it are awesome. Changing the culture will require that these interests be aligned and that public-private partnerships be developed. But what, exactly, do we want a hospital to do? We have a clear idea of what a culture of safety looks like. How do we get there?

How to Do It

How do we transform the dysfunctional cultures of health-care organizations into cultures of safety? How do we motivate CEOs to make safety a priority, take responsibility for making it happen, inspire others to join the cause, and create an environment of transparency , respect, and personal responsibility?

The leading thought leaders in patient safety have described visions of what a safe culture should be but often have been humble about providing advice on how to get there.

Reason speaks of “engineering” a safe culture in general, not specifically in health care. He describes the critical subcomponents: a reporting culture, a just culture , a flexible culture , and a learning culture . He notes that a safety culture is far more than the sum of its parts, that the rest is “up to the organizational chemistry” [8]. How to create that chemistry is left unanswered.

Likewise, Vincent describes the ingredients in a safety culture and notes that the evidence from studies such as those of Singer [19] shows that a better safety climate is associated with fewer adverse events . But he, too, shies away from prescribing how to achieve a safe culture [7].

However, in their perceptive and influential book, Safer Healthcare: Strategies for the Real World , Vincent and Amalberti provide a prescription for achieving safe care that would, in fact, require significant culture change [20]. They observe that the approach to improving patient safety has been too limited, focusing primarily on hospital care and too little on primary care and home care, and that the method used was the same in all settings: improvement of a core issue in a narrow time scale with a specific process change such as the surgical checklist or CLABSI protocol.

They call for a much broader approach using five safety strategies:

• 1. Safety as Best Practice: aspire to standards—reducing specific harms and improving clinical processes, such as the CLABSI protocol and the surgical checklist

• 2. Improvement of Healthcare Processes and Systems: intervening to support individuals and teams , improving working conditions and organizational practices, such as improved handovers, use of daily goals and huddles, and barcoding of medications

• 3. Risk Control: placing restrictions on performance, demand, or working conditions , such as regulations governing radiation therapy, closing unsafe facilities, and limiting individual licenses or privileges

• 4. Improving Capacity for Monitoring, Adaptation, and Response, such as briefings and debriefings, safe reporting, family engagement, and emergency planning

• 5. Mitigation: planning for potential harm and recovery, such as providing patient and peer support after harm

They then show how these five strategies can be used in three settings: hospital, home, and primary care. The specific issue of changing the culture to enable implementation of these strategies is not addressed, however.

Shanafelt et al. are more prescriptive [21]. They describe the steps that must be taken to change the culture of medicine: create psychological safety for people to learn new things, identify collaborative strategies for physicians and leaders to gain experience with new modes of working, and provide resources and formal training, advisors, and coaching. They emphasize that the leader must be convinced of the need to change and spearhead and support the initiatives. Individuals who are the targets of the change must be involved in the process [21].

IHI /Safe and Reliable Healthcare Framework

In 2017, the IHI and Safe and Reliable Healthcare jointly published A Framework for Safe, Reliable, and Effective Care [9]. The authors, Allan Frankel , cofounder of Safe and Reliable Healthcare, and Carol Haraden , Frank Federico , and Jennifer Lenoci-Edwards , of IHI , propose that achieving safe and reliable care requires attention to three domains: leadership , culture, and the learning system.

The paper provides direction to health-care organizations on the key strategic, clinical, operational, and cultural components involved with each and how they interact. It provides definitions and implementation strategies for nine foundational components: leadership , psychological safety , accountability , teamwork and communication, negotiation, transparency , reliability, improvement and measurement, and continuous learning .

Each of the nine components is described with specific major points, followed by a section, Moving from Concept to Reality, which describes the steps to implementing the ideas in daily practice. For example, the Framework uses Edmondson’s definition of psychological safety [22]:

• Anyone can ask questions without looking stupid.

• Anyone can ask for feedback without looking incompetent.

• Anyone can be respectfully critical without appearing negative.

• Anyone can suggest innovative ideas without being perceived as disruptive.

It then gives advice on how to achieve psychological safety , such as coaching, huddles, solicitation of ideas, and providing feedback to suggestions. As the authors suggest, the report provides a framework for thinking about patient safety; training, guidance, and support are also needed. It is not a blueprint or detailed plan.

ACHE /LLI Leading a Culture of Safety

That blueprint is provided for the key element for culture change , leadership , by another publication in 2017, Leading a Culture of Safety : A Blueprint for Success, jointly published by the American College of Healthcare Executives and the Lucian Leape Institute [23]. The most detailed and prescriptive advice published so far, its central theme is that leaders create safety. The product of two roundtables of those who have led and those who have studied successful transformations, the document is “an evidence-based, practical resource with tools and proven strategies to assist (leaders) in creating a culture of safety ” [23].

The mission is clearly stated up front: “It is both the obligation and the privilege of every healthcare CEO to create and represent a compelling vision for a culture of safety : a culture in which mistakes are acknowledged and lead to sustainable, positive change; respectful and inclusive behaviors are instinctive and serve as the behavioral norms for the organization; and the physical and psychological safety of patients and the workforce is both highly valued and ardently protected…. The elimination of harm to our patients and workforce is our foremost moral and ethical obligation” [23].

The document addresses both “foundational” elements—what is needed to establish a culture of safety —and “sustaining” elements, what is needed to make it permanent. It describes in detail the many elements of both strategy and tactics that are needed to accomplish the objectives. These are organized into six leadership domains that require CEO focus and dedication:

• 1. Establish a compelling vision for safety . An organization’s vision reflects priorities that, when aligned with its mission, establish a strong foundation for the work of the organization.

• 2. Build trust , respect, and inclusion. Establishing trust , showing respect, and promoting inclusion—and demonstrating these principles throughout the organization and with patients and families—are essential to a leader’s ability to create and sustain a culture of safety .

• 3. Select, develop, and engage your Board . CEOs are responsible for ensuring the education of their Board members on foundational safety science .

• 4. Prioritize safety in the selection and development of leaders. Include accountability for safety as part of the leadership development strategy for the organization. In addition, identify physicians, nurses, and other clinical leaders as safety champions.

• 5. Lead and reward a just culture . Workers must be empowered and unafraid to voice concerns about threats to patient and workforce safety .

• 6. Establish organizational behavior expectations. These include transparency , effective teamwork , active communication, civility, and direct and timely feedback.

Leading a Culture of Safety is a landmark publication. It is by far the most comprehensive exposition of what is needed to achieve a safe culture in health care. It is a blueprint constructed by the most respected leaders in the field that makes a clear and powerful statement that the trust and openness needed to achieve a safe culture start at the top.

Examples of Success

A handful of health-care organizations have succeeded in changing their cultures . Several are worth examining for lessons learned.

Virginia Mason Medical Center

In 2000, Virginia Mason Medical Center (VMMC) in Seattle was in trouble. It was losing money, and it became apparent that the old model based on professional excellence was insufficient. The Board and top management had all read the IOM reports and realized that they too had quality and safety problems and inefficiencies. The Board asked, “if we are so focused on patients, why are all the systems built around the doctors?” Agreeing, Gary Kaplan , the new CEO , proposed to change from a physician-driven organization focused on volume to a patient-oriented organization based on quality of care. The Board gave him full support.

Kaplan and his senior management team spent the next year looking unsuccessfully for a health-care management system to achieve this goal. They then accidentally met John Black , a former Boeing executive, who told them of the impact of implementing the management system Lean . They visited businesses in the USA that used Lean and decided it was what they needed.

Lean is derived from the Toyota Production System that was developed in the 1930s when Toyota began producing automobiles [24]. It is founded on the concept of continuous and incremental improvements of product and process and eliminating waste. It is “a way to do more and more with less and less - less human effort, less equipment, less time, and less space - while coming closer and closer to providing customers exactly what they want” [25].

Lean is based on five key principles:

• 1. Value: Specify the value desired by the customer.

• 2. Value Stream: Identify the value stream (the steps in a process) that provides value for each product, and challenge all of the wasted steps.

• 3. Flow: Make the product flow continuously through the remaining value-added steps.

• 4. Pull: Introduce pull between all steps where continuous flow is possible.

• 5. Perfection: Manage toward perfection so that the number of steps and the amount of time and information needed to serve the customer continually fall [26].

Persuaded by Black and Carolyn Corvi , who had led dramatic improvements in the production of the 737 aircraft, Kaplan took his senior executive team to Japan to study the Toyota Production System . They were profoundly moved. Workers and managers worked in harmony to produce a flawless product, an automobile. Kaplan’s team could see that these methods could be adapted to health care. They came home determined to develop a Virginia Mason Production System (VMPS) .

Aren’t You Ashamed?

One experience at Toyota struck home with particular force. A sensei (teacher) reviewing a VMMC floor plan with the team asked what a certain area was. A waiting room, they said. “Who waits there?” Patients. “For whom?” The doctor. The sensei then found that there were 100 waiting rooms at VMMC and that patients waited on average 45 minutes for a doctor. “Aren’t you ashamed?” he said [27]. Suddenly the team understood what “patient first” meant.

Back home, selling VMPS to the staff was another matter. While many—particularly the younger ones who had embraced quality improvement—were supportive, some of the senior staff, including some department chairmen, were not. They rebelled, objected, and in some cases resigned. Education about the new system and training leaders took a year or more, but it was imperative, and the investment of time proved worthwhile.

The changes proposed were indeed monumental. It took several years to implement them, and the work is never done. Four features drove the transformation:

• 1. A shared vision outlined within a strategic plan that places the Patient First in everything, always. The strategic plan evolved into a “pyramid” figure with the patient at the top; under that, the vision and the mission; and then the values teamwork , integrity, excellence, and service.

• 2. Alignment of mission and values from the board down. Alignment means all parties share common focus, common goal, common language, and common culture . The “pyramid” facilitates alignment —there is no ambiguity that the patient’s interest is always first.

  A key instrument for achieving alignment is the compact, an agreement between the organization and physicians that made explicit the reciprocal obligations of both. It took a year to develop. Additional compacts were developed for leaders and for board members.

• 3. A single improvement method—VMPS —that enables continuing improvements in quality, safety, access, efficiency, and affordability, every day at every level of the organization.

• 4. A culture predicated on deep respect for people and continuous improvement. Two aspects are fundamental: respect, meaning every voice is not only heard, but listened to, and teamwork that stimulates personal and professional growth and performance.

The transformations of the VMPS were many and profound. They have been extensively documented and explained in several books that are well worth reading [27,28,29].

Here are a few examples:

Standard Work

A challenge for physicians was the concept of standard work , a cornerstone of innovation in Lean. Reducing variability ensures quality while making it easier to identify and deal with necessary exceptions. Standard work means that all have the obligation to follow a process that is defined by consensus among stakeholders as the most effective and safest. Embracing this concept was an essential first step in establishing the new culture . Over the years, VMMC developed over 70 “must do” processes.

Kaizen Promotion Office (KPO)

“Kaizen” is Japanese for continuous incremental improvement. It assumes that frontline workers are the source of ideas of how to remove waste and improve processes but lack the expertise to develop the new processes. Expert help is needed. At VMMC , the KPO provides that help. The KPO was a clear signal that VMMC was serious about VMPS .

Rapid Process Improvement Workshops (RPIW)

One of the earliest innovations introduced was the Rapid Process Improvement Workshop . This is an intensely serious effort to address a defined quality or flow problem. Trained and certified Workshop leaders convene a team of stakeholders and KPO experts to work full time for 5 days to analyze a problem, identify waste, define the value stream , and reengineer the process. Stretch goals are set—typically 50% for operational issues, 100% for safety.

Examples of innovation from RPIWs include eliminating the waiting rooms in outpatient clinics, cutting triage time in the ER in half, and the institution of Saturday hours. A powerful example was redesigning the cancer center, which took multiple RPIWs .

When VMMC decided to move the cancer center to a large floor with windows all around the periphery, the doctors assumed that is where their offices would be. Not so. If VMMC was serious about putting the patient’s interest first, they would go to the patients. And so it was, with the doctors and nurses having their offices and common areas internally.

Not only did the patients get the nice rooms, they could stay there. Analysis of the “value stream” showed that cancer patients typically spent hours walking all over the hospital to see multiple specialists; get X-rays, lab tests; etc., in addition to lying in bed for hours for intravenous infusion. The fix? A truly radical idea: let them stay in the room and have everyone come to them. Result: the duration of patient visits fell by 50%, patient satisfaction rose to 95%, and VMMC took care of 1100 more patients a year with no increase in staff [27].

Patient Safety Alerts (PSA)

Safe and frequent reporting of errors , adverse events , near misses, and hazards is essential to improvement. You can’t fix something you don’t know about. VMMC labelled them Patient Safety Alerts (PSA) and patterned the response after Toyota’s “Stop the Line.” Mishaps were no longer “events” to be reported and perhaps evaluated, they were real-time indicators of failure and harm and got immediate attention.

Two features distinguish the PSA system from the usual reporting system: everyone is empowered and obligated to report them in real time, and every report leads to a response. The response may be immediate, stopping a treatment to correct or understand an error or near miss, or urgent root cause analysis , or as an agenda item for improvement. The PSA system enables the frontline worker to directly engage leadership in a collaborative relationship. It is also tangible evidence of the institution’s commitment to the target of perfection.

Since its inception in 2002, the PSA system has resulted in 100,000 reports that led to responses and changes that over time dramatically reduced the rate of adverse events and “near misses.” Risk-adjusted mortality declined, as did liability costs .

Patient Safety as a Primary Goal

In 2004, Mary McClinton died at VMMC during a radiological procedure as a result of accidental intravenous injection of an antiseptic, chlorhexidine, instead of contrast material. The hospital was devastated. Unequivocally committed to transparency , Kaplan went public, explained what happened, and apologized. The newspapers remarked on how unusual his transparency was (and, sadly, still is).

Mary McClinton’s death had a profound impact on the hospital staff. In the previous two years, they had made great strides in improving processes and reducing errors . How could this happen? Clearly, they still had a long way to go to achieve harm-free care. But the experience with improving quality and the development of a culture of openness and trust gave them confidence to proceed. The response was quick and decisive: patient safety would not just be part of the transformation, it would become its overarching goal. Prevention of harm would be the core focus for the next several years.

Respect for People

In 2011, after a decade of incredibly successful cultural transformation, a routine survey showed that, like other health-care organizations, nearly half of employees still did not feel safe in speaking up about a personal mistake. Lynne Chafez , General Counsel and leader of the changes at VMMC , asked me to come out and consult with them.

We had just written our papers on respect (Chap. 21), so I shared our discovery of the unrecognized subtle forms of disrespect that are pervasive in health care. It fell on fertile ground. They listened, and they responded by developing the Respect for People program as a major safety goal. VMMC developed an educational course on respect that was required for all 5000 of their staff. The approach has subsequently been adopted by hundreds of other hospitals worldwide. It identified ten foundational behaviors expected of everyone working at VMMC . They speak volumes about the kind of culture it strives to be (Box 23.1).

Box 23.1 Respect for People

Foundational behaviors

• 1. Listen to understand

• 2. Keep your promises

• 3. Be encouraging

• 4. Connect with others

• 5. Express gratitude

• 6. Share information

• 7. Speak up

• 8. Walk in their shoes

• 9. Grow and develop

• 10. Be a team player

Adapted from Ref. [28].

Secrets of Success

The transformation of VMMC was a profound and dramatic culture change . It was challenging, it was threatening, and it never stops. Reflecting on 18 years of progress, Gary Kaplan identified four key transformations that led to successful culture change :

First, Board and governance engagement. Members of the board are responsible for governance, not just to attend meetings and leave quality to the doctors, but as partners to achieve it. Board members are trained in VMPS , and, like all senior leaders, every member of the Board is required to go to Japan at least once in their first term. They undergo regular self-evaluation as a board and as individuals.

The Board is seriously involved in ensuring patient respect and care. Patient care failures and successes are presented at every meeting, sometimes by the patient in person. The Board reviews every red PSA (an event that has harmed a patient or has the potential to) and must sign off on the prevention plan before it is implemented.

Clearly, it is a very different kind of board from those of most health-care organizations. Members are neither appointed by CEO nor beholden to him. They are chosen for their expertise, literacy and commitment, not their status in the community or largess. They bring curiosity, active engagement and dissent in open meetings, and, as defined in their compact, relentless commitment to the strategic plan. Outside experts such as Julie Morath and Gregg Meyer are included on the oversight committee.

Second, Kaplan believes changing minds of leadership is crucial. All members of the “C-suite”—including legal counsel and the CFO—have to become champions to support middle management. Trust, alignment , and workers’ sense of value depend on leadership . Trust comes from leaders being vulnerable in the sense of being willing to admit mistakes and take advice from others. Alignment depends on leaders who are value-driven, embrace the mission and the strategic plan, and have clarity about purpose. Alignment to purpose and respect for people gives workers passion about their work and meaning to their lives.

Continuing development of new leaders is the key to sustainability. VMMC has an active program to continually identify, develop, and formally train leaders at all levels. One or two people are always prepared to step up when someone leaves.

The third critical transformation is transparency—truth telling—shining a light on mistakes. Transparency creates the culture that makes reporting work; it reveals behaviors that are not consistent with patient first . It ensures open and honest communication with patients when things go wrong. A culture of transparency revealed the problem of disrespect . External transparency , as in the McClinton’s, builds trust with the public.

Finally, the fourth transformation is the centerpiece respect for people , listening and responding to staff concerns and holding all accountable for respectful conduct with one another and with patients.

VMMC is a model of the transformation needed for a health-care organization to develop a culture of safety . Safety is an organizing principle of its daily work, a pillar supporting its mission to provide high-quality effective care. Zero harm is the goal, safety is everyone’s responsibility, and innovation and improvement are part of everyday work. Not surprisingly, year after year, VMMC has been named as one of the top hospitals in the nation by Leapfrog. Hundreds of health-care organizations have come to VMMC to learn how to transform. May they all succeed.

Cincinnati Children’s Hospital

When Jim Anderson took over as CEO at Cincinnati Children’s Hospital (CCH) in 1997, he found a hospital that, like most academic institutions of the time, prided itself on its research excellence and assumed that its patient care was excellent as well. Anderson was not so sure. Having been CEO of a manufacturing firm, he knew something about quality improvement, and he knew CCH could do better. Lee Carter , the new board chair agreed. He was especially interested in increasing the focus on patients and families.

In 1999, they initiated a strategic planning process that asked their various communities about challenges over the next 3–5 years. One of the groups said that despite having great physicians and nurses, the institution did not provide an environment for the best delivery of that care.

There was more disturbing news. CCH had just joined the Cystic Fibrosis Foundation (CFF) National Quality Initiative, a collaborative with other hospitals to improve the care of cystic fibrosis patients. When they received comparative feedback of baseline data of measures of nutrition and pulmonary function, they were shocked to find that CCH was not only not in the top 10 as they expected, but its results were below the national average.

From his business experience, Anderson knew that fixing quality problems was not only the right thing to do, but that the savings more than offset the costs , making also a compelling business case. Poor quality came from inept management. Carter agreed. They could do better.

The release of the IOM report, To Err is Human , provided additional impetus. Quality and safety were compelling issues they needed to address. CCH’s new 5-year strategic plan made a commitment to dramatically transform the way they delivered health care. Uma Kotagal , who had led earlier performance efforts, was put in charge.

Lee Carter’s comment was memorable: “Well, if we are not the best, we can certainly be the best at getting better, and then we will be the best.” He established and chaired the Board Patient Care Committee, composed of doctors, nurses, business people, board members, and members of the community.

In the middle of the strategic planning process came the opportunity to apply for a Pursuing Perfection grant from the Robert Wood Johnson Foundation (RWJF) (see Chap. 6 for program details). CCH competed against over 200 hospitals and was one of only four chosen. They would focus on one evidence-based practice , bronchiolitis, and one chronic condition, cystic fibrosis , which they knew from the national quality initiative they needed to work on. After a struggle with CFF, they obtained the name of the hospital that was the national leader in cystic fibrosis care and sent a team to learn from them how to improve their care of these patients.

A core requirement of the RWJF grant was transparency and patient engagement. The Foundation funded and helped produce a video of CCH parents of patients with cystic fibrosis who volunteered to describe their experiences. The film was devastating. It depicted multiple errors in the care they were receiving. Anderson showed it to the Board Patient Care Committee. They were speechless, except for the doctors or nurses who said, “Of course, that’s how the system works.” Anderson and Kotagal had their work cut out for them.

Participating in Pursuing Perfection had a powerful impact on CCH. While it yielded impressive successes, it also revealed how far they had to go to build capacity to make widespread change. Kotagal realized that people didn’t know how to make change. They needed to be trained. She sent key staff to take Brent James ’ QI course in Salt Lake City.

A central feature of the reorganization was the establishment of clinical systems improvement (CSI) teams consisting of a physician leader, a nurse leader, and executive for each of five domains: inpatient, outpatient, perioperative, home health, and emergency. These CSI teams were responsible for major issues such as flow, safety, and patient experience. They worked with and sponsored unit teams headed by a physician leader and the nurse manager to test patient safety initiatives. All were required to take the course on leadership and capability development.

A robust measurement system was developed to document outcomes, and within each domain influential physicians and nurses formed improvement teams for key negative outcomes such as ventilator-associated pneumonia, catheter-associated bloodstream infections , surgical site infections, and adverse drug events . A senior leader was assigned as champion for each team. Families were involved as members of the teams . Stretch goals were set and met.

Significant improvements occurred and were sustained. As they increased QI capability and developed knowledge of reliability design, they were able to further improve and simultaneously carry out dozens of improvements and build systems capable of 95–99% reliability.

Nonetheless, in 2005 the organization realized its rate of sentinel or serious safety events (SSE) was still high. With the help of consultants, it decided to change the safety management system to apply HRO concepts. They developed five key drivers to achieve a goal of reducing the SSE rate by 80% over 3 years:

• 1. Restructured governance for patient safety

• 2. Developing a highly reliable error prevention system

• 3. A transparent culture of continuous learning

• 4. State-of-the-art detection and cause analysis system

• 5. Focused intervention on perioperative processes and culture

Senior leaders adopted Patient Safety as the core value of the organization, and a commitment was made to change the culture by changing behavior. All frontline staff were trained on key safety behaviors, reinforced daily via safety coaches. An organization-wide focus on “Days since the last SSE” continuously gave a sense of wariness and unease. SSE were reduced by 65% in 3 years.

A rigorous root cause analysis process was implemented, overseen by the legal department to ensure that it was a trusted process that everyone could believe in. Senior executives were accountable to make sure it happened in timely way. They took ownership of the problem. This led the staff to have confidence in the process and accept transparency .

In 2005, Cincinnati Children’s Hospital, now called Cincinnati Children’s Hospital Medical Center (CCHMC), partnered with the other children’s hospitals in Ohio and the Ohio Children’s Hospital Association to improve safety. The first effort was implementation of medical response teams in all of the hospitals. Cardiopulmonary arrests outside of intensive care units were reduced by 46%. As Kotagal’s successor, Steve Muething , recalled, this was a “game changer” for CCHMC: they realized that they could improve better and have more influence by working with others.

Under the leadership of Muething and the new CEO , Michael Fisher, and with funding from CMS and private industry, CCHMC joined the other Ohio children’s hospitals in 2009 to formalize this collaboration for safety as the Ohio Children’s Hospitals’ Solutions for Patient Safety network . Hospital personnel were trained in the Model for Improvement and shared lessons learned with one another. ADEs were subsequently reduced by 50% and SSIs in high-risk children by 60% in all eight hospitals.

In 2012, 25 hospitals across the nation joined the initial 8 Ohio hospitals to form Solutions for Patient Safety (SPS) , a network that eventually grew to 142 children’s hospitals collaborating to reduce serious patient harm . From 2011 to 2018, hospitals in the SPS reduced their adverse drug events by 74%, catheter-associated urinary infections by 50%, falls by 75%, and pressure ulcers by 27%.

Kotagal and Muething attribute CCHMC’s success to six factors:

• 1. Alignment and commitment. From the beginning, Anderson, Carter, and Kotagal were clear and unambiguous about the focus and led the board , senior leaders, and CSI chairs to share a deep commitment to zero serious harm , leadership improvement, and partnerships between physicians and nurses and between leaders and researchers.

• 2. Structure for change and integration. The creation of Clinical System Improvement teams of top leaders for each of the major delivery systems gave coherence and clear responsibility for major changes to improve flow, processes, and patient experience. They worked with unit teams led by trained physician and nurse leaders who carried out specific projects, aligning macro-, meso-, and microsystem structure across the entire system. Patient safety and staff safety were integrated.

• 3. Capability and capacity for change. From the beginning, the organization invested deeply in training in the science of improvement and in the infrastructure support, analytics, and operational research needed to create good visibility of data, response, and action.

• 4. Creation of a culture of continuous learning . Creation of psychological safety , the opportunities for constant improvement, and training in leadership and quality improvement created an environment where learning is part of everyday life.

• 5. Respect for the Science. The belief in the scientific approach enabled the organization to be rational and logical and attract very bright people with a passion to do well by children.

• 6. Transparency. A culture where it is normal and expected that people will surface, address, and ultimately solve issues/problems every day at all levels, especially when things go wrong, is the foundation of trust . Adverse events were promptly acknowledged to the staff, patients, and the public, thoroughly investigated, and the results fed back to the family and to the clinical staff for improvement.

Cincinnati Children’s Hospital Medical Center has truly created a culture of safety . It has developed, and continues to refine, a sustainable model of collaborative patient and staff engagement in continuing improvement that has dramatically reduced harm for its patients. It has stimulated other children’s hospitals to change their cultures and collaborated with them to do so. They are an impressive model.

Denver Health

Denver Health (DH) is an example of an apparently impressive culture change that turned out to be illusory. Denver Health is the principal safety-net provider in Colorado, providing health care for nearly a third of Denver’s population, 46% of whom are uninsured. In 2004, under the leadership of its CEO , Patricia Gabow , MD, and with a grant from AHRQ , DH began a major initiative to transform the way it delivered care, centered on five “Rights” :

• Right People: a workforce committed to customer service and quality

• Right Environment: appropriate patient and work spaces

• Right Reward for employees who demonstrate customer-oriented behaviors

• Right Communication and Culture

• Right Process: application of Lean to eliminate waste

Gabow created a new department to take responsibility for patient safety and quality and focus on processes to improve care. Programs were created to manage high-risk and high-opportunity clinical situations, such as failure to rescue, use of antibiotics, CLABSI, etc . Systems were implemented to reduce variability in patient care processes and outcomes. The initiative was supported by a sophisticated electronic health record that provided order entry and decision support in addition to data for research and quality improvement [30].

Like VMMC , Denver Health developed an intensive approach to process change , the Rapid Improvement Event (RIE) , a four-day group session focused on an identified problem to develop a method to remove it. Rapid improvement events resulted in marked advances in diabetes care, anticoagulation management, venous thromboembolism prophylaxis, and cancer screening rates.

In its first 4 years, DH estimated that it also gained $42 million in financial benefit due to reduced waste. In 2009, it had the lowest observed/expected aggregate mortality ratio among 106 academic health centers in the University HealthSystem Consortium. Denver Health was hailed as an impressive example of rapid and effective culture change .

Gabow retired in 2012, having received numerous awards and honors for her impressive work at transforming a health-care organization. In 2014, she told her story in The Lean Prescription: Powerful Medicine for Our Ailing Healthcare System, which she wrote with Philip Goodman [31].

Then it came undone. Gabow was succeeded by Arthur Gonzales, who quickly undid many of Gabow’s changes in response to financial pressures associated with the Affordable Care Act. His leadership style alienated physicians and led to resignations of a number of physicians, including all of the chairs of the major departments. Gonzales was later replaced by Robin Wittenstein .

The rapid reversal of the culture at Denver Health illustrates the difficulty of making real culture change that is sustainable. The impressive transformations implemented by Gabow were evidently not institutionalized well enough among the executive leaders, employees, and middle managers to withstand a change of top leadership . The culture really didn’t change. And one can infer that the board was not totally engaged in the transformation and lacked continuity of purpose, or it would not have hired a CEO who put financial goals over safety.

Safe and Reliable Health Care

On a national scale, the most comprehensive effort to date to change culture by developing organizational capacity and capability is a proprietary effort developed by Safe and Reliable Healthcare (S&R) , the consulting firm established by Allan Frankel and Michael Leonard , two highly respected physicians who have devoted their professional careers to improving patient safety. Frankel was for years the chief patient safety officer for Partners Healthcare in Boston and on the faculty at IHI . Leonard was for many years the chief safety officer at Kaiser-Permanente .

S&R trains a health-care organization’s leadership and its personnel to create and sustain the environment for safe care. The focus of the S&R method is to give frontline personnel voice and a sense of community. Voice , or agency, means that everyone feels safe to speak up and that their voice is heard and respected and influences what takes place. Community means that everyone feels that their co-workers care about them. The S&R approach changes the structure of the management of the delivery of care and improvement so that voice and community are intrinsic to everyday work.

The following description is adapted from the S&R website [32]:

The core of the S&R approach is a digital platform called LENS™ (L earning and EN gagement S ystem) , an interactive electronic replacement of the white board where staff gather daily to define issues, develop plans, receive updates, celebrate achievements, and recognize contributions. It enables physical and virtual rounds, huddles, and improvement work so that leaders and managers can effectively communicate and visibly “close the loop” on ideas and concerns shared by frontline teams . This enables real-time coordination and improvement as well as alignment and coordination within a unit and collaboration across multiple teams . Frontline teams have “voice , visibility, and ownership” in shaping their unit’s culture and performance.

(a) Uma Kotagal, (b) Allan Frankel, and (c) Mike Leonard. (All rights reserved)

A key element is SCORE , a system that obtains survey data and provides analysis to support LENS . It builds on and expands the earlier surveys of patients and providers developed by Sexton, AHRQ, and others but differs by being correlated with outcomes based on data from over 700 organizations. SCORE includes questions on culture , engagement, burnout , resilience, patient experience, physician satisfaction, and Magnet. It maps to AHRQ /SOPS , SAQ, and other surveys, thus enabling use of previous data to benchmark and show improvement. Data are presented graphically and automated to show unit results and trends across the organization.

S&R team of experts provides guidance for becoming a high-reliability organization . The goal is to generate organizational capacity and a sustainable architecture for excellence by empowering leaders, managers, and teams to clearly understand what they must measure and improve across their transformation journey. The S&R approach holds great promise. It seeks to change the culture by changing behavior at all levels. To the extent that includes engaging top management and the boards in the transformation, the changes should be sustained.

As of this writing, 12 systems of care, representing dozens of hospitals and hundreds of care units, are working with S&R to create safe and cost-effective health care . Time will tell if they succeed.

Making It Happen

What will it take to get hospitals and health-care systems nationwide to implement the VMMC , CCHMC, or S&R models to make the transformations needed to change their cultures ? As the experiences of VMMC and CCHMC show, the CEO must have the vision and skills to make it happen and the passion and commitment to carry through. The Board must share that commitment and provide the resources and the backup when the going gets tough.

Perhaps exposure to advanced thinking about leadership , quality, and patient safety, such as by the initiative of the ACHE , combined with increasing evidence of success by peer health-care organizations, will motivate more leaders of organizations to “do the right thing.”

But the motives of others engaged in reform may be less high-minded. For a decade or so, CEOs have been bombarded by a stream of articles in the Harvard Business Review and elsewhere about the power of Reliability Science to improve efficiency, including occasional examples in health care. They are beginning to realize that managing the complexity of care demands standardization and simplification of services and that these changes require employee engagement.

So, to be financially sound and deliver safe care, they have joined the trend to embrace reliability science and Lean . The “in” thing is to become an HRO . Many major health-care organizations now have a process engineering office and black belt leaders. The employee focus has advanced from satisfaction to engagement, resilience, and wellness. Resistance to change has lessened as the fraction of younger physicians has increased and the values of autonomy and hierarchy are being replaced by cooperation, teamwork , and respect.

This is an encouraging trend, but there is a dark side. The major trend is directed at the bottom line: consolidation . In our profit-oriented fee-for-service health-care system, market share is everything. Across the country, the big guys are swallowing up the little guys. Some are long-standing, national in scope, and huge, such as HCA (186 hospitals), Ascension Health (151), and Trinity Health (104), and span large geographic areas. Others, such as MGH Brigham (14) in Boston and Northwell (23) in Long Island, are expanding regional monopolies. Others are doing the same thing.

The primary objective of consolidation is financial success. National systems implement standardized practices to increase profits by improving efficiency and reducing costs . Regional monopolies also seek to eliminate competition in order to guarantee market share and raise prices.

In fairness, it is important to note that some large consolidated systems have been leaders in quality improvement and safety. In the current milieu, they can be an effective way to spread systems changes such as Lean and worker engagement. We have the “Ascension Way,” the “Trinity Way,” etc. that, when well directed, can result in significant changes.

Nonetheless, in most systems, the CFO keeps management focused on the bottom line. The demand for productivity and profits competes with quality and safety, and usually wins, as evidenced by the high burnout rates among physicians and nurses in many of these hospitals. Safety is not the primary goal.

A Role for Government?

So the big question is what will it take to get all hospital CEOs and Boards motivated to make the culture change we need to make care safe and efficient? To make patient safety “job one”? There is no clear answer, but several possibilities come to mind.

One would be federal oversight. Congress could create an FAA equivalent for health care, a Federal Patient Safety Agency, FPSA , to set standards and monitor and enforce compliance . In addition to setting standards for physician competence as described in Chap. 20, the Agency would develop standards for all aspects of health-care delivery in collaboration with representatives from hospitals and health-care systems, the Joint Commission , professional societies, and experts in quality and safety. As noted earlier, participation by stakeholders in developing standards ensures relevance and buy-in with a higher likelihood of compliance .

Specifically for safety, the Agency would set standards for practice, including training in quality and safety, data collection, working conditions , coordination of care, transparency , and reporting. It would require reporting of all serious reportable events . Failure to report would have consequences, such as prohibiting reimbursement of a hospital for any charges for an admission with a SRE. Repeat offenders could be fined and face loss of accreditation .

Given the current political climate, indeed, the climate of the past several decades, it seems highly unlikely there would be Congressional support for significantly increased regulation. A lesser measure, such as requiring enterprise liability in which the health-care organization is held accountable for a patient injury rather than the physician, might be possible and would be useful, but also seems unlikely.

Can nongovernmental oversight, such as by the Joint Commission , provide sufficient pressure to motivate health-care organizations to change their cultures ? Perhaps. Over the past few years, the Joint Commission has steadily increased requirements for accreditation to promote quality and safety, including implementation of safe practices , reporting of SRE, adherence to core measures of quality, ensuring physician competence , patient engagement , and assessment of patient experience. (See Chap. 12.) Joint Commission Patient Safety Goals have been internalized by many hospitals. These measures have had an impact on the cultures .

However, the ability of the Joint Commission to expand its requirements is limited by its vulnerability to competition. CMS also accepts accreditation of hospitals by other organizations to receive the essential “deemed status” that enables them to receive payments from Medicare and Medicaid. Because these alternative programs are less demanding, they are an attractive “way out” if TJC gets too tough. This could, of course, be turned around if CMS gave the Commission sole accrediting authority, subject to CMS oversight.

A “Burning Platform” ?

Some believe that health-care organizations will not change in the absence of an existential threat, a “burning platform.” That our dysfunctional system has to get worse before it can get better. To really be threatening, that threat has to be financial.

Many, your author included, believe that the fundamental cause of the dysfunction of the American health-care system is the way hospitals and doctors are paid. The USA is the only advanced economy that runs health care as a business. That business is based on the fee-for-service (FFS) system for paying for health care. The primary goal of any business is to make a profit. In a fee-for-service system , the more services hospitals or doctors provide, the better they do.

The ramifications and nuances of this system are far too complex to be dealt with here, but the implications are clear: in a FFS payment system , the need to focus on productivity and profit is a major deterrent to hospitals making quality of care and patient safety their core mission. Changing to a risk-adjusted capitated system, such as an accountable care organization , with oversight to ensure that standards of appropriateness, quality, and safety are met, would give new meaning to the “bottom line.” By itself, changing the payment system would not change the culture , but it would remove the major barrier and provide the right incentives.

Will the COVID-19 pandemic be the “burning platform” that forces change? Under its stress , our health-care system collapsed. Increasing demand for highly expensive COVID care, coupled with a decline in demand for routine services, led to crippling financial losses that have driven substantial numbers of hospitals and office practices into bankruptcy, especially rural and safety net hospitals. In our FFS business model, when markets collapse, so do providers [33].

The pandemic also significantly undermined the system of funding of health care for patients. Millions lost their employment-based health insurance when they lost their jobs [33]. Government subsidies were insufficient to make up for these losses.

As of this writing, it is impossible to know how things will turn out. However, the crisis has increased the national will for universal coverage and for insurance that is not work-related. A substantial majority of Americans now embrace the concept that health care should be a right. All of the approaches to achieve that goal require significant long-term federal outlays, as well as a huge infusion of funds short-term to prevent further collapse of the system.

Will this unprecedented requirement to fund coverage also lead to the recognition of the need to redesign the health-care system to eliminate unnecessary, harmful, and wasteful care? To design a system to meet patient needs, not to make money ? Will it be what it takes to move Congress to change the financing of health care from fee-for-service to capitation, from for-profit care to patient-centered accountable care? Will this be what it takes to make patient safety a reality? If so, our suffering will not have been in vain.