As we move into an attempt to recover from the first wave of the COVID-19 pandemic, many of us have begun to think about how the delivery of healthcare will be changed by what we have experienced. Some have suggested that the pandemic has revealed serious flaws in the organization of care and how it is financed. One of the most troubling observations has been that the discrepancies in access to care have been multiplied by the pandemic and reflected in the increased mortality of those who were experiencing the greatest challenges from inequality and difficulties with the social determinants of health before the pandemic. This should not have been a surprise to us. Theodore Roosevelt pointed out the need for a better approach to care  over a hundred years ago. Franklin Roosevelt would have included some form of national healthcare in Social Security, but was told that doctors would fight it and that resistance would jeopardize the passage of social security. The compromises necessary to pass the original Social Security Act perpetuated existing inequalities because farm and domestic workers, many of whom were African Americans, were excluded from the 1935 Social Security Act.  

 

After Medicare and Medicaid were passed and the Johnson’s War on Poverty began we entered a long debate about how to improve the health of the nation. The quality movement began in the eighties while simultaneously there were continuing efforts to pass some form of expanded coverage, if not universal coverage. The passage of the Affordable Care Act in 2010 was an amazing accomplishment, but it left tens of millions of Americans still vulnerable to their chronic medical conditions and without any form of coverage. What we have failed to admit all along the way to the pandemic is that covered or not covered, we are all vulnerable when there is anyone among us who does not get the care they need. We have built the arguments for healthcare around the needs of neglected individuals, and have failed to realize that if anyone had inadequate care we are all at risk. 

 

It is time for us to realize that the healthcare challenge that faces us is not limited to getting universal coverage for those who have no insurance. The great challenge in the post COVID-19 world will be to discern how we secure access to health as an entitlement for everyone and simultaneously improve the performance of the system of care for all of us. There is a deeply held conviction by many Americans that healthcare can be improved by competition in the private sector. The private sector is focused on the profit margins of individuals and institutions. Historically, healthcare has been resistant to government involvement at any level. The last fifty years have been an experiment in bringing government into healthcare as a “payer” through a heavily debated and tediously slow process over roles and responsibilities. When the government pays it also rightfully expects a voice in policy and performance issues. I believe that we all have suffered from the fact that we have failed to recognize that healthcare, like defense, is a concern that demands a level of consensus on policies that can create a system that has the resilience to protect us all from the external threats of natural pandemics and the real threat of human engineered biological warfare. I hope that the lesson learned from going through this awful experience will be that we all see the need for bipartisan consensus on the necessity to articulate a more functional public/private partnership for healthcare that will be a benefit for everyone in a better future. 

 

For the system to be better for everyone, we will need to articulate the roles and responsibilities for individuals, healthcare providers, employers, payers, states, and the federal government. Let’s use transportation as an analogy. We allow private companies to build cars for sale to individuals, but what they build must comply with safety regulations. We expect the government to fund private firms to build the roads and bridges through local, state, and national contracts. Those roads and bridges allow our cars to move us around and trucks to bring us the things we need. Suppliers like the petroleum industry, local car dealers, banks, insurance agencies, and garages are all coordinated to perform in the arena that is defined by local, state, and federal governments. The local, state, and federal governments also create and enforce the rules that provide safety on those highways and the businesses that make it work. There is definitely a well understood public/private partnership that supports the needs of individuals and underlies the infrastructure of our transportation capabilities. No one thinks that our transportation system represents a slippery slope to socialism.

 

We will not improve the health of the nation or protect our economy from the impact of pandemics or biological warfare until we develop the rudimentary level of bipartisan agreement that allows us to fund and manage our healthcare in a way that is similar to how we manage transportation and our military/industrial defense system. I hope that the key lesson learned from the pandemic will be that private interests alone will never protect the health of the nation, but that the health of the nation depends on a private system of care that has two objectives. First it must be designed to have each provider participate in the collective system of care that is directed by public policy. Second, that each provider and participating organization works internally to improve the care to individuals as it works externally within the framework of the larger system to improve the health of the population. 

 

We have understood what we should be doing for a couple of decades. Crossing the Quality Chasm summarized the problems as we had come to understand them in the eighties and nineties and proposed ways of moving forward that were built on what we had learned when we turned our attention to the interplay between cost and quality. Since its publication we have all known that you can’t spend your way to quality care. It works the other way around. A patient centered focus on improving quality leads to lower costs and better outcomes. We have long known that quality requires better engineering of systems, and is the product of collaboration. As we stand on the threshold of the “new normal” we share a desire not to go through what we have just experienced again. We should also know that to avoid a second wave of this virus or the visitation of an even more potent virus in the future we have many improvements that we must make at the local and national levels, in the private sector, and in the public sphere. 

 

We have been trying to apply continuous improvement science to healthcare for over thirty years. In January 1989 Don Beriwck published “Continuous Improvement as an Ideal in Health Care” in the New England Journal. The majority of healthcare practitioners, practices, hospitals, and health systems with which I am familiar would be offended if they were told that they really didn’t follow the principles of continuous improvement, but they don’t, and neither does the government.

 

In this important article written before there was much medical literature extolling or condemning TQM, Lean, or Six Sigma,  Don must have been assumed that names like Shewhart, Deming, or Juran would fall on ears that would not know if they were little known former athletes, obscure economists, or minor poets. It is remarkable to me that in his list of fifteen references, there are no medical papers cited! The closest he comes to the medical literature is with the first reference from the Government Printing Office (GPO) in 1988 entitled “Health Care Financing Administration. Medicare hospital mortality information.”

 

Anyone who has ever heard Don Berwick speak or read much of what he writes knows that he  depends on stories and analogies to educate us and make his points in ways will stick in our  brains. He begins this article, which has been cited nearly a thousand times by other authors, with a tale of two “Foremen.” These low level managers of a process are charged with the same job of improving production and quality of their product. Don tells us that “Forman 1” is a tough guy who operates by a pattern all too familiar to most workers. He walks the assembly line closely observing all that they do while saying:

 

“I can see you all, …I have the means to measure your work, and I will do so. I will find those among you who are unprepared or unwilling to do your jobs, and when I do there will be consequences. There are many workers available for these jobs, and you can be replaced.”

 

The second Foreman is not nearly as overbearing. He walks the line like “Foreman 1,” but that is where the similarity ends. As he walks, he is delivering a different message:

 

“I am here to help you if I can,” …. “We are in this together for the long haul. You and I have a common interest in a job well done. I know that most of you are trying very hard, but sometimes things can go wrong. My job is to notice opportunities for improvement — skills that could be shared, lessons from the past, or experiments to try together — and to give you the means to do your work even better than you do now. I want to help the average ones among you, not just the exceptional few at either end of the spectrum of competence.”

 

Don turns to us and asks:

 

Which line works better? Which is more likely to do the job well in the long run? Where would you rather work?

 

Don tells us that “Foreman 1” operates on the theory of “bad apples.” He wants better tools for finding those bad apples. His cause is pure. He wants better healthcare. You might use another metaphor and say that he is looking to “drain the swamp.” 

 

In 1989 Don knew for sure that this type of fellow existed because he had been trying to improve quality in healthcare for over a decade. I know that Don knew for sure because Don had been my colleague for that decade. He explains what he means: 

 

…those who subscribe to it [Theory of improvement by removing bad apples]  believe that quality is best achieved by discovering bad apples and removing them from the lot. The experts call this mode “quality by inspection,” and in the thinking of activists for quality in health care it predominates under the guise of “buying right,” “recertification,” or “deterrence” through litigation. Such an outlook implies or establishes thresholds for acceptability, just as the inspector at the end of an assembly line decides whether to accept or reject finished goods.

 

Don’s dismal picture of the search for bad apples leads to further analysis and description:

 

The sad game played out in this theory and the predictable response to it imply a particular view of the nature of hazard and deficiency in health care, as it does in any industry playing such a game. The view is that problems of quality are caused by poor intentions. The Bad Apple is to blame. The cause of trouble is people — their venality, incompetence, or insufficient caution. According to this outlook, one can use deterrence to improve quality, because intentions need to be changed; one can use reward or punishment to control people who do not care enough to do what they can or what they know is right.

 

I guess that the reflex to look for bad apples exists in most complex human interactions. Identifying problems leads to assigning blame. We have been doing a lot of problem identification and blame assigning over the last two months. It is a reflex that is hard to unlearn. My post from last Friday is a good example of how we use it. I delivered much of my own criticism and quoted heavily from articles by Dr. Elisabeth Rosenthal and Dr. Sidhartha Mukherjee who both had long lists of items that failed the inspection forced by the COVID-19 pandemic. 

 

Don’s second foreman takes a different approach. 

 

Real improvement in quality depends, according to the Theory of Continuous Improvement, on understanding and revising the production processes on the basis of data about the processes themselves. “Every process produces information on the basis of which the process can be improved,” say these theorists. The focus is on continuous improvement throughout the organization through constant effort to reduce waste, rework, and complexity. When one is clear and constant in one’s purpose, when fear does not control the atmosphere (and thus the data), when learning is guided by accurate information and sound rules of inference, when suppliers of services remain in dialogue with those who depend on them, and when the hearts and talents of all workers are enlisted in the pursuit of better ways, the potential for improvement in quality is nearly boundless…

 

Don then introduces Deming and Juran, the two Americans who gave Japan the fundamental principles of continuous improvement that evolved into Lean. He explains their core beliefs and the benefit of their approach:

 

They discovered that problems, and therefore opportunities to improve quality, had usually been built directly into the complex production processes they studied, and that defects in quality could only rarely be attributed to a lack of will, skill, or benign intention among the people involved with the processes. Even when people were at the root of defects, they learned, the problem was generally not one of motivation or effort, but rather of poor job design, failure of leadership, or unclear purpose. Quality can be improved much more when people are assumed to be trying hard already, and are not accused of sloth. Fear of the kind engendered by the disciplinary approach poisons improvement in quality, since it inevitably leads to disaffection, distortion of information, and the loss of the chance to learn.

 

I have always been inspired by the generosity and certain truth of those observations. I think that Dr. Rosenthal and Dr. Mukherjee were identifying systems issues in healthcare that were present long before 2016. 

 

I have believed in the principles of continuous improvement for a long time. Don left Harvard Community Health Plan to start the Institute for Healthcare Improvement about the same time the article was published. I have long believed that the reason Don left us has also been the reason that Lean and other forms of continuous improvement have had difficulty gaining true acceptance in healthcare. That reason is that middle and upper management has a very difficult time shedding the mindset of “Foreman 1,” and fails to accept the truth that the people who do the work know how to improve the work. 

 

In a recent Modern Healthcare article [published as a PDF and requiring a subscription to read] entitled “Lean management used improperly by many health systems” written by Maria Castellucci, Gary Kaplan of Virginia Mason implies that Virginia Mason would not have responded as effectively to COVID-19 if they had not had Lean. He also implies that most healthcare organizations misuse Lean. On the positive side he says:

 

“I think about how we were changing gears, changing approaches, modifying work teams, modifying workflows, at times cutting back on things and at other times escalating things like televideo or drive-through testing.”

 

I believe Kaplan’s assertion that Lean has enabled Virginia Mason’s response to COVID-19. As a board member of the Guthrie Clinic, I know that Guthrie’s response to COVID-19 was enabled by both their facility with Lean tools, but most importantly with their embrace of Lean philosophy and use of Lean as their management platform. I also believe that those organizations that have adopted Lean philosophy, learned the Lean tools, and have transformed their operating system by demanding that all of their managers and executives function as Don Berwick’s “Foreman 2” will be well prepared to play their role in developing “the new normal.” Castellucci also quotes another giant of Lean in healthcare, John Toussaint, as saying:

 

“If you haven’t developed a Lean management system … this (pandemic) will be the

turning point,”…“Without that system in place, and it’s a very specifically designed system, you just can’t manage this crisis or the next one.”

 

It took more than a decade after Berwick’s 1989 paper for innovators like Kaplan and Toussaint to establish Lean as the operating system in their organizations. I know from the personal experience of trying to establish Lean in a healthcare practice that it is a multi year endeavor. The picture in the header for today is of the participants in one of the early rapid improvement  events (RIE) in our organization. I am the grey haired fellow with a bowtie on the left. Our RIE was not about saving money, it was about improving blood pressure management. Improving blood pressure does lower the cost of care, and as we now know, having high blood pressure not only makes you vulnerable to heart disease and stroke, it also makes you vulnerable to be a victim of the pandemic. 

 

Don was very clear in 1989 about the benefits he saw on the horizon for healthcare if we could all adopt processes of continuous improvement. He writes:

 

Real improvement in quality depends, according to the Theory of Continuous Improvement, on understanding and revising the production processes on the basis of data about the processes themselves. “Every process produces information on the basis of which the process can be improved,” say these theorists. The focus is on continuous improvement throughout the organization through constant effort to reduce waste, rework, and complexity. 

 

I added the bolding because I think the principle that Don was advancing was exactly what Rosenthal and Mukhargee were doing. The data from COVID-19 reveals many of the things we need to “fix” as we move into the new normal. Don offers even more advice from thirty years ago that hits the target today. Don gives us six points, a furthermore, one “in addition,” and a “finally.”

 

• First, leaders must take the lead in quality improvement. 

 

 

• Second, investments in quality improvement must be substantial. …improvement requires additional investments in managerial time, capital, and technical expertise. .. The most important investments of all are in education and study, to understand the complex production processes used in health care; we must understand them before we can improve them.

 

 

• Third, respect for the health care worker must be reestablished. Physicians, hospital employees, and health care workers, like workers anywhere, must be assumed to be trying hard, acting in good faith, and not willfully failing to do what they know to be correct. 

 

• Fourth, dialogue between customers and suppliers of health care must be open and carefully maintained. 

 

 

• Fifth, modern technical, theoretically grounded tools for improving processes must be put to use in health care settings….The techniques of process flow analysis, control charts, cause- and-effect diagrams, design experimentation, and quality-function deployment, to name a few, are neither arcane nor obvious…they require study, but they can be learned. 

 

 

• Sixth, health care institutions must “organize for quality.” ...Flexible project teams must be created, trained, and competently led to tackle complex processes that cross customary departmental boundaries. Throughout the organization, a renewed investment must be made in training, since all staff members must become partners in the central mission of quality improvement.

 

• Furthermore, health care regulators must become more sensitive to the cost and ineffectiveness of relying on inspection to improve quality. In some regulatory functions, inspection and discipline must continue, but when such activities dominate, they have an unfavorable effect on the quality of care provided by the average worker.

 

 

• In addition, professionals must take part in specifying preferred methods of care, but must avoid minimalist “standards” of care...Health care producers who commit themselves to improvement will invest energy in developing specific statements of purpose and algorithms for the clinical processes by which they intend to achieve those purposes. 

 

 

• Finally, individual physicians must join in the effort for continuous improvement…Individual physicians caring for individual patients know that defects in the care they provide do not usually stem from inattention or uninformed decisions...Flawless care requires not just sound decisions but also sound supports for those decisions. For the average doctor, quality fails when systems fail. 

 

 

I know from personal experience that every one of those points are right. I would add a tenth point:

 

Any organization that wants to do Lean right needs a teacher. A Lean transformation can not be a process like cutting your own hair in a mirror. Kaplan and Toussaint had the wisdom to bring in consultants, to visit other industries, and transform their operating systems as they simultaneously used the language and philosophy Berwick’s of the “second Foreman” to change the culture of their organizations. 

 

I have seen organizations who tried to use Lean as learned from a book, or that thought they could hire one Lean expert to teach them what that needed to know. “Do it yourself Lean” fails. Toyota had Deming and Juran to guide them. Kaplan had guidance from people who were experienced in Lean form Boeing. Toussaint was fortunate that his organization, ThedaCare, was located near Ariens, another manufacturer that had been transformed by Lean. 

 

As both Rosenthal and Mukherjee implied in the articles that I quoted last Friday, issues of healthcare finance were significantly responsible for the way our system of care was not prepared for the pandemic. It is interesting that Mukhergee began his article with a story that revealed a defect in the Toyota Production System (Lean) use of “Just in Time” inventory and supply chain management. What should not be lost is the reality that Lean practitioners love failures. Failures make us aware of where improvement is needed and what we must do to make it possible. The title of Mukhergee’s article was a good review of its content: “What the Coronavirus Crisis Reveals About American Medicine: Medicine is a system for delivering care and support; it’s also a system of information, quality control, and lab science. All need fixing.” I would contend that if we really want to fix what needs fixing we should recognize that we must all speak the language of continuous improvement. 

 

The president has complained in the past that healthcare was too complex. Healthcare is complex, but it can be improved. I would advise organizations that want to recover from the setbacks of the COVID-19 experience and join in the effort to be better prepared for the next challenge to consider adopting the suggestion that Don offered 31 years ago. What we have learned during that time is that change is hard work and that to be successful it requires focused leadership in collaboration with those who have done it before and can effectively help them learn the philosophy and the tools that will enable an effective transformation. If you are a senior manager of a healthcare organization, and are are considering a Lean transformation, the best thing you can do to prepare for the new normal after COVID-19 is to be sure that you hire a good Lean consultancy to educate you and your staff. I know from my experience and from observing others, that you can’t be your own Lean guru. Everyone, especially the senior leaders and CEO, needs an experienced coach. If this were easy, everyone would have done it a long time ago. Lean transformations in other industries are difficult, but rarely do those industries contain the complexities that exist in healthcare. 

 

In a recent article entitled “The world after Covid-19,” Daniel Jones, one of the pioneers of Lean in industry, and the author of The Machine That Changed The World, writes:

 

The true significance of this lean business system is not that it improves the performance of the legacy assets of the mass-production age – big factories, big warehouses, big stores, big hospitals, big airports etc. It does, of course, but it can also iteratively scale up new technologies much faster through several generations with user feedback. Most significantly, it can mobilize the creative contribution of everyone, including users, to develop very different and sustainable systems for the future. We can’t simply rely on experts to meet these challenges for us. We all have to be active participants in shaping our future as consumers and as providers of solutions. The lean business system provides the organizational framework to do just that. It is up to us lean thinkers to help mold the post-pandemic world into a more equal, sustainable and collaborative place.

 

 

I really like the fact that Jones envisions a world where we can shape a better future for everyone. He notes that everyone has a role to play in the creation of our better world, and I am convinced that we need the organizational framework for collaboration that Lean offers us. We can’t be passive and let others do it for us. As he says:

 

We all have to be active participants in shaping our future as consumers and as providers of solutions. The lean business system provides the organizational framework to do just that.