Health Care Heroes: Don Berwick, MD – Adapting industrial quality improvement principles to the improvement of health care processes

Last week, Don Berwick, MD, announced his resignation as Administrator of the Centers for Medicare and Medicaid Services (CMS).  Now is a good time to explain why Dr. Berwick is one of my all time health care heroes.

Don Berwick as one of the Notre Dame Four Horsemen on Ward's coffee mug

Apparently, I talk about Dr. Berwick a lot. A few years ago, I received one of my most treasured gifts from colleagues at Blue Cross Blue Shield of Michigan (BCBSM).  It was a coffee mug featuring the famous photograph of the Four Horsemen of Notre Dame, a reference to my undergraduate alma mater.  My colleagues replaced the faces of three of the horsemen with the faces of three of my health care heroes, Drs. Paul Ellwood (the person who coined the terms “health management organization” and “outcomes management”), David Eddy (the clearest thinker on the topics of clinical practice policies and the rational allocation of health care resources), and Don Berwick. The face of the forth horseman they replaced with my own face.  I considered it a great honor to be associated with my heroes, at least on a coffee mug.

My team at BCBSM had heard me repeatedly explain Dr. Berwick’s important contribution to adapting the quality improvement  principles that had been successfully used in manufacturing to the health care field.  Others had been involved in promoting “continuous quality improvement,” “statistical process control,” and “total quality management” in health care. Paul Batalden, Brent James, Eugene Nelson, and Jack Billi come to mind, to name but a few. But, in my opinion, it has always been Berwick that has been the most eloquent and persuasive. He connected the statistical tools emphasized by James with the front line worker involvement emphasized by Batalden. And, he was able to describe how these approaches applied to clinical decision-making as well as care delivery.

At the heart of Dr. Berwick’s contribution was teaching us all to distinguish between the “Theory of Bad Apples” and the “Theory of Continuous Improvement.”

According to the Theory of Bad Apples, errors come from “shoddy work” by people with deficient work performance.  Leaders who uphold this theory focus on inspection to identify such deficient performance, indicated by the undesirable tail in the distribution of provider performance as shown on the left side of the diagram above.  Then, such leaders focus on holding the bad performers “accountable” by applying disciplinary measures intended to motivate improvement in performance and by pursuing other interventions intended to re-mediate the bad performance.  In the health care context, the workers are physicians and the shoddy work is poor quality health care. According to Berwick, the predictable defensive response by the physicians who are targeted for such remedial attention includes three elements: (1) kill the messenger, (2) distort the data and (3) blame somebody else.

Berwick advocates instead for the Theory of Continuous Improvement.  The basic principles of this theory are

  • Systems Thinking: Think of work as a process or a system with inputs and outputs
  • Continual Improvement: Assume that the effort to improve processes is never-ending
  • Customer Focus: Focus on the outcomes that matter to customers
  • Involve the Workforce: Respect the knowledge that front-line workers have, and assume workers are intrinsically motivated to do good work and serve the customers
  • Learn from Data and Variation to understand the causes of good and bad outcomes
  • Learn from Action: Conduct small-scale experiments using the “Plan-Do-Study-Act” (PDSA) approach to learn which process changes are improvements
  • Key Role of Leaders: Create a culture that drives out fear, seeks truth, respects and inspires people, and continually strives for improvement

T-Shirt of "Berwickians" -- the staff of epidemiologists and biostatisticians at BCBSM

Berwick argued the point made by Dr. Deming:  if we  can reduce fear, people will not try to distort the data.  When learning is guided by accurate information and sound rules of inference, when suppliers of service remain in dialog with those that depend upon them, and “when the hearts and talents of workers are enlisted in the pursuit of better ways, the potential for improvement in quality in nearly boundless.”

I first was influenced by Dr. Berwick back in the 1980’s when he championed these ideas during his tenure at the Harvard Community Health Plan, and subsequently during the 1990’s when he led the National Demonstration Project on Quality Improvement in Health Care and the Institute for Healthcare Improvement.  His face was already on my coffee mug at the time he was nominated to lead CMS.  I was thrilled that someone from our community of people dedicated to clinical process improvement had been recognized and would be serving in a position of such influence.

The Irony of the Political Opposition to Berwick’s Role as CMS Administrator

Dr. Berwick’s candidacy as CMS Administrator faced stiff opposition from Republican leaders who were angry about anything connected to the health care reform law or, for that matter, the Obama administration itself.  The President made the decision to evade this opposition by making a recess appointment of Dr. Berwick.  But, such recess appointments have a limited lifespan.  As the deadline for making a formal, congressionally sanctioned appointment approached at the end of the 2011 legislative session, 42 Republican senators signed a letter reiterating their disapproval of Dr. Berwick as CMS Administrator.   The arguments against Dr. Berwick’s  candidacy, both at the time of his original nomination and again over the last few months, centered around comments that Dr. Berwick has made praising the British health care system.  They concluded from his comments that he was in favor of redistributing wealth to the poor and of rationing, the dreaded “R” word, the thing done by “death panels!”  He was, therefore both a bleeding heart and heartless at the same time.  Dr. Berwick denied these charges, but the opposition was unconvinced and unwilling to back down from a position of persistent opposition to anything connected to “Obamacare.”

The irony is that, of the heroes on my coffee mug, Dr. Berwick is not the one deserving of praise for having insight and bravery concerning the basic tenets of health economics. Instead, it was Dr. David Eddy’s mug that was on my coffee mug because he was brave enough to publish numerous papers in the Journal of the American Medical Association explaining why rationing was the right thing to do (e.g. this one and another one).  Eddy argued that creating evidence-based “practice policies” that rationally allocated health care resources using “explicit methods” was favorable to using implicit methods supported only by “global subjective judgement.”  What a radical thought!

Despite my great admiration for Dr. Berwick, he was the hero that disappointed me as a rationing denier.  In fact, in a 2009 paper published in Health Affairs entitled “What ‘Patient-Centered’ Should Mean: Confessions of an Extremist,” he eloquently argued that we should give any patient whatever they wanted, regardless of the cost and regardless of the evidence of effectiveness.  He discounted the role of the physician as a steward of resources.  I felt the argument was heartfelt and humanistic.  But, I felt it was a cop out.  How strange, then, that the Republican opposition hoisted him on the rationing petard.

Looking Forward to Berwick’s Next Journey

Although it is disappointing to me that Dr. Berwick will no longer be leading CMS, I am eager to see what he chooses to do next.  I’m sure he will continue to make a great contribution to our field.  Without all the administrative and political duties to clog up his day, perhaps we are about to witness a surge in his ongoing contributions to improving health care.

More information: See Health Affairs article and associated Health Affairs Blog Post praising Dr. Berwick.

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Health Care Heroes: Wilmer Rutt, MD – Adapting the R&D Concept to Health Care Provider Organizations

Wilmer Rutt, MD - Director of Henry Ford Health System Center for Clinical Effectiveness, in his office at New Center Pavillion, 1993

This morning, I read the results from a clinical trial of ovarian cancer screening in JAMA.  The trial showed that ovarian cancer screening was not effective in saving lives.  I was interested in the article because I was one of the investigators in that trial, which began in the early 1990s.  Henry Ford Health System was the largest of many recruitment sites for the Prostate, Lung, Colorectal and Ovarian (PLCO) trial, one of the largest clinical trials ever done.  I’m not surprised by the ovarian cancer results, since our models long ago suggested it was unlikely to work.  But, it is amazing to me how long it takes to figure out whether something works in health care, particularly for interventions that are preventive services or that attempt to change the delivery system.  It is unfortunate that the “learning loop” — from innovation to implementation to evaluation and back to innovation — is often far longer than our collective attention span.

But, the back story of how Henry Ford got involved in the PLCO trial is the most interesting aspect of the PLCO story for me.  It is the story that best illustrates why Wil Rutt, MD is one of my health care heroes.  When I was fresh out of University of Chicago medical school in 1990, I moved to Detroit to work with Dr. Rutt, who had recently founded the Center for Clinical Effectiveness (CCE) at the Henry Ford Health System.

In other industries — particularly product manufacturing industries — it is typical for companies to invest in internal capacity for research and development (R&D).  Universities and governments do basic research, figuring out how nature works.  But, it is companies that do R&D to apply basic knowledge to the development of successful products.  They generate ideas for product innovations.  Then they use rigorous methods of scientific research and engineering to figure out whether those innovations are successful and to develop ways of manufacturing the product.  Separate from such R&D efforts, manufacturers also have engineers in the product manufacturing area that try to improve manufacturing processes.  To do so, these engineers use methods variously described as statistical process control, continuous quality improvement, total quality management, six sigma, and lean.  Drug and biomedical device companies are product manufacturers, and share this tradition of investing in both R&D and manufacturing process improvement.

In the field of health care delivery, there has been great progress over that last few decades in adapting the process improvement methods from manufacturing for use in health care.   Drs. Don Berwick, Paul Batalden, Brent James, and Jack Billi come to mind as zealous advocates for this advancement. And, certainly there have also been plenty of health services researchers, mostly in universities and government-sponsored think tanks, who have done research on health care delivery organizations, studying such organizations as anthropologists might study gorillas in the mist.

Mark Muller, Wei Chang, Kim Sadlocha and Rick Ward in the the offices of the Center for Clinical Effectiveness, 1993

But, as of 1990, there was little or no precedent for non-academic health care provider organizations to do R&D, the kind of practical work applying rigorous scientific and engineering methodologies to improving the design of a company’s own product or service.  Wil Rutt’s CCE was one of the first attempts to apply R&D to health care delivery. He assembled a team of doctors, PhDs, IT professionals and others to design better ways for Henry Ford Health System to deliver health care.  The CCE did extra-murally funded research intended to be generalizable to the world.  But the focus was on R&D for Henry Ford, and the grants and papers were merely a means to that end.

One of Dr. Rutt’s many innovation concepts during the early 1990s was the idea to design a care process that resembled the Jiffy Lube oil-change process to deliver clinical preventive services.  At that time, there were upwards of 50 different preventive services recommended in the U.S. Preventive Services Task Force guidelines.  Dr. Rutt’s CCE developed pocket-size guideline manuals, age and gender-specific flow sheets, and preventive services quality feedback in an effort to promote adherence to preventive services guidelines by primary care physicians.  But, he concluded that it would be better to cross train non-physician staff to efficiently deliver a whole set of preventive services to patients during a single ambulatory encounter.  He wanted these services to be delivered in a convenient setting such as a shopping mall rather than on a clinical campus. He called these “Health Assessment Labs” or “HALs.”  However, Dr. Rutt needed funding to implement and rigorously evaluate the HAL concept.  Along came the National Institutes of Health (NIH), who was sponsoring the PLCO trail.  Dr. Rutt saw the opportunity for Henry Ford to be a clinical site for the PLCO.  We won a grant to do so, and became the largest of the many PLCO clinical sites.  That grant was one of the largest research grants ever received by Henry Ford Health System, which is no slouch in clinical and basic science research.  But, Dr. Rutt’s thrill was not the research fame.  It was the opportunity to do R&D on the HAL concept.

Two decades later, we are still, as a field, at the infancy of our journey to adapt the R&D concept to health care delivery.  Certain delivery systems, such as Kaiser Permanente, Mayo Clinic, Cleveland Clinic, and Novant have discussed an R&D-like concept of developing proprietary science, technology and methods for care delivery.  But, the R&D concept has not really taken hold.  Health care provider organizations do not yet consider R&D to be a core competency.  Hardly any provider organizations have an internal department dedicated to R&D.  They don’t yet see R&D as a necessary investment required to maintain organizational competitiveness.  I feel strongly that we need to finish making that advancement.  And when we do, we’ll owe a debt of gratitude to Dr. Rutt for being the pioneer.

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