Archive for the ‘Healthcare Quality’ Category

Quality Guru Chosen to Head CMS

Tuesday, May 11th, 2010


Donald Berwick


Donald Berwick, a Harvard University professor and leading advocate for improving health-care quality and efficiency, has been named by President Obama as his choice to head the Centers for Medicare and Medicaid Services (CMS.) Berwick is well-known in Quality circles for aggressively advocating quality improvement in healthcare. Berwick, who specializes in health-care policy and pediatrics, has never led such a large organization. As head of the Boston-based Institute for Healthcare Improvement, however, he is known for persuading doctors and hospitals to adopt innovative methods for reducing medical errors. Dr. Berwick is author of numerous articles and books, including the classic work demonstrating the application of quality technology to health care issues, Curing Health Care. He is one of the nation’s leading authorities on health care quality and improvement. He is also Clinical Professor of Pediatrics and Health Care Policy at the Harvard Medical School, and Professor in the Department of Health Policy and Management at the Harvard School of Public Health.

If confirmed by the Senate, Berwick will face a number of daunting challenges. One is the sheer size of the CMS, which is about to become even larger. The agency, which is part of the Department of Health and Human Services, must oversee a massive expansion of Medicaid, the federal-state insurance program for the poor, with an estimated 16 million people expected to join its rolls by 2020. At the same time, Medicare, the insurance program for the elderly, will need to reduce payments to health-care providers by about $400 billion over 10 years without impacting the quality of coverage. Lean Six Sigma and Quality technologies provide an approach for doing this while minimizing the impact on value-added health care processes, operations and activities. Berwick’s familiarity with these areas provides reason for optimism or, at least, hope. This blog has frequently posted examples of poor quality in health care. Let’s hope that Dr. Berwick will have a positive impact at CMS.

GD Star Rating
loading...

Doctors Perform C-Section on Woman Who Wasn’t Pregnant

Friday, April 2nd, 2010

The North Carolina Medical Board recently reviewed a case where doctors and interns tried to induce labor on a patient, and then performed a Caesarean section, but found there was no baby inside the woman’s womb, Foxnews.com reports. Apparently an intern did an ultrasound before the surgery and could not find a heartbeat. It was at this time that the patient convinced doctors to induce her. The medical board said the intern did not have enough experience to make the “appropriate diagnosis.”

No kidding.

It was determined that the patient suffered from pseudocyesis, which is the medical term for “false pregnancy.” A person suffering from pseudocyesis may often have all the same signs and symptoms as a person who is actually pregnant, but there is no fetus.

While I accept the likelihood that pseudocyesis was the patient’s root problem, I am curious about the failed ultrasound. As father of three and grandfather of two I’ve seen a few fetal ultrasounds. Although I’m not expert enough to use them for diagnoses, I think even I could determine if a full-term fetus was there or not.

The desperate need for process improvement in healthcare continues to blare forth in the headlines. I may need to start a regular feature on the subject!

GD Star Rating
loading...

Standard Diabetes Treatment Makes Things Worse

Monday, March 15th, 2010

Ready-Fire-Aim. Once again the healthcare profession finally gets around to looking at data, only to discover that it is actually harming patients by treating them. The Los Angeles Times reports that a major nationwide trial called ACCORD released Sunday show that lowering either blood pressure or cholesterol levels below current guidelines do not provide additional benefit and, in fact, increase the risk of side effects. A third arm of the study, released two years ago, shows that lowering blood sugar levels excessively actually increases the risk of heart disease.

The Lean Six Sigma and Quality professions learned long ago that there is no substitute for facts and data. In pursuing Lean Six Sigma so many myths are exploded that we soon come to question any so-called fact that can’t be supported with evidence, with the important exception of creative ideas and innovation. As time goes by the value of this position becomes obvious. As change agents trained in the approach move into positions of leadership the organization’s DNA begins to change.

In most industries mistakes result in an economic loss. Although serious, it is usually possible to learn from mistakes and improve. In contrast healthcare mistakes create health consequences, sometimes as serious as death. Yet the healthcare profession remains incredibly resistant to using facts and data to guide their recommendations and treatment. The ACCORD study is but the latest example. A few years ago the ENHANCE study produced similar lessons regarding the treatment to prevent heart disease. Other studies show that low cost diuretics are as effective as the high priced prescription medications normally prescribed. Another study showed that the standard treatment for sudden deafness is no better than a placebo. Still another showed that the standard of care for certain breast cancers was based on fraudulent research and killed patients.

All of these studies have a number of things in common. All were conducted to verify treatments that had been in use for many years. All showed that the treatments were either worthless, or worse than worthless. And most have been largely ignored by the healthcare profession.

It’s anyone’s guess when the healthcare profession will join the business community in embracing process improvement. Let’s hope it happens soon, before change is forced upon them.

GD Star Rating
loading...

Unreliable Prostate Test Costs Billions

Thursday, March 11th, 2010

The person who discovered the test used to screen 30 million American men for prostate cancer, the prostate-specific-antigen or PSA test, says the test is a hugely expensive healthcare disaster. In the New York Times Op-ed piece  The Great Prostate Mistake Professor Richard J. Ablin  states

“I discovered P.S.A. in 1970. As Congress searches for ways to cut costs in our health care system, a significant savings could come from changing the way the antigen is used to screen for prostate cancer.”

Americans spend an enormous amount testing for prostate cancer. The annual bill for P.S.A. screening is at least $3 billion, with much of it paid for by Medicare and the Veterans Administration. Meanwhile, the test is hardly more effective than a coin toss. P.S.A. testing can’t detect prostate cancer and, more important, it can’t distinguish between the two types of prostate cancer — the one that will kill you and the one that won’t.Instead, the test simply reveals how much of the prostate antigen a man has in his blood. Infections, over-the-counter drugs like ibuprofen, and benign swelling of the prostate can all elevate a man’s P.S.A. levels, but none of these factors signals cancer. Men with low readings might still harbor dangerous cancers, while those with high readings might be completely healthy.

So why is it still used? According to Ablin it’s because drug companies continue peddling the tests and advocacy groups push “prostate cancer awareness” by encouraging men to get screened. Shamefully, the American Urological Association still recommends screening, while the National Cancer Institute is vague on the issue, stating that the evidence is unclear.

The bottom line?

“Testing should absolutely not be deployed to screen the entire population of men over the age of 50, the outcome pushed by those who stand to profit.”

This according to the man who discovered the test over four decades ago.

Personally, I think the logic used in Professor Ablin’s op-ed piece should be used to assess the value of all recommendations used to test and medicate Americans into bankruptcy without improving health in the slightest.

GD Star Rating
loading...

Does Six Sigma Apply to Healthcare?

Friday, February 12th, 2010

Tom Pyzdek is interviewed by Steven C. Wilson on Quality Conversations. Click to listen.

Tom Pyzdek radio interview

Steven C. Wilson interviews Tom Pyzdek

GD Star Rating
loading...

Healthgrades Identifies Best Hospitals

Tuesday, January 26th, 2010

In a report released today the organization healthGrades identifies hospitals in the top 5% of the nation for clinical excellence. Healthgrades estimates that 150,132 Medicare lives could potentially have been saved and 13,104 Medicare inhospital complications could potentially have been avoided if all hospitals performed as well as the top 5%. Lean Six Sigma practitioners know from experience that such improvements are not impossible, if the organization commits itself to process excellence.

HealthGrades assesses the quality of care provided at the nation’s 5,000 nonfederal hospitals. It looks at 26 diagnoses and procedures and requires that hospitals have star ratings in at least 19 categories to be considered for recognition as a HealthGrades Distinguished Hospital for Clinical Excellence™ (DHA-CE.) The Healthgrades process for recognition is quite transparent:

After creating a list of hospitals that met the above criteria, HealthGrades took the following steps to determine the DHA-CE recipients.

  1. Calculated the average star rating and average z-score for each hospital by averaging all of their MedPAR-based ratings and the corresponding z-scores.
  2. Ranked hospitals in descending order by their average star rating, with ties broken by average z-score.
  3. Selected the top 269 hospitals on the list (which represents the top 5% of all hospitals).
  4. Designated the hospitals as recipients of the 2010 Distinguished Hospital Award for Clinical Excellence.
GD Star Rating
loading...

Why Healthcare Quality Stinks in America

Monday, December 7th, 2009

Let’s be honest, America’s healthcare non-system has its problems. What are the root causes? Do any of the proposed solutions address them?

GD Star Rating
loading...

Why Healthcare Quality Stinks

Monday, November 30th, 2009
Tom Pyzdek

Tom Pyzdek

Let’s be honest, America’s healthcare non-system has its problems. Let’s not quibble over whether or not it is better than socialized systems. For one thing, the demand side is already socialized. Nearly 90% of the cost of healthcare is paid for by third parties, either the insurance company or a government program like Medicare or Medicaid. When a person doesn’t have to bear the cost of the product or service they receive, whatever the system is, it isn’t Capitalism. The supply side however, is pretty much free, at least in the sense that the patient has free access to whatever services and medications their primary care physicians prescribe. The physician doesn’t pay for it; the patient doesn’t pay for it. How about a CT Scan for that pain you’ve had for the past couple of days? Why not? You’re not paying for it!

Exactly what to call this arrangement escapes me. I think there’s plenty of ammo here for a lively political debate where both sides can point fingers at the failings of the other side. There’s plenty of blame to go around. However, it’s not my purpose to examine the whole healthcare issue in this single column. Instead, I’d like to discuss the impact of the current ridiculous situation on the field I’ve spent a lifetime in: quality.

Once upon a time I was working with hospitals trying to improve quality. I assume that we can all agree that this is a worthwhile effort. After all, there is little argument that there is room for improvement. The 1999 report “To Err is Human” by the Institute of Medicine estimated that medical mistakes kill about a jumbo-jet full of people each and every day, and subsequent studies by other groups have shown this to be a low estimate. Anyway, I was lucky enough to work with groups of dedicated healthcare professionals who were able to make significant improvements in areas such as reduced infections, reduction of unnecessary c-sections, faster response times, etc.. The result was a reduction in the average length of stay, fewer readmissions, and other improvements that patients and their families were happy about. One of the most enthusiastic of those working on quality improvement was a young man who I will call Rob. Rob had a great deal of experience in all aspects of hospital administration and soon found himself appointed as administrator of a 500 bed medical center. All of us who had worked with Rob were delighted and we looked forward to an expansion of the quality improvement work Rob had championed when he was in middle-management.

For a while, that’s exactly what we got. Rob’s leadership support began making big dents in chronic problems that were costly in terms of unnecessary patient suffering as well as in waste due to preventable problems. Thanks to Rob I was able to attend meetings with the hospital board of directors, where Rob arranged to have quality improvement teams present their remarkable results to apparently enthusiastic board members.

Soon, however, the atmosphere at these meetings began to change. The chairman of the board, also the president of the bank which held most of the hospital’s debt, pointed out to Rob that the reduced patient-days, lower number of c-sections, reduced readmissions, etc. were cutting into the hospital’s revenue stream. He pointed out the obvious: private and government insurance company money was available to pay for treating a medical mistake, there was no way to know if many c-sections were necessary or not, a readmission paid the same as a first admission. In short, quality improvement was costing the hospital money.

Rob wasn’t blind to the implications. If he couldn’t get revenues up, he would be replaced. Furthermore, in addition to the pressure from the board, physicians were also grumbling about the impact of improved quality on their incomes. Quality was nice to talk about, but when it came to actually giving up the added income, well, that was another story. Rob had a simple choice: follow his conscience and lose his job, or return to business as usual. Soon the quality improvement activities were reduced to a few token people. Gradually, the improvements came undone. Rob eventually lost his job anyway, but the message was clear enough that his successors had no difficulty figuring it out.

In typical buyer/seller situations the problems would be resolved by competition. If one manufacturer’s television set isn’t as good as another the word will spread and people will vote with their dollars for the better value. However, try finding out about the problems at your local hospitals. Or about your physician’s performance relative to others in your area. I’ve tried. And while I’ve discovered some sources of information, the data seems skimpy to me and, shall we say, sanitized. I don’t see the kind of honest customer commentary I see in places like Amazon.com. I suspect there are forces at work making the world work this way.

To summarize: based on personal experience I can tell you that the quality tools that work with other industries work just as well in healthcare. This is no surprise, really. Healthcare has processes, and our tools help people rapidly improve processes. Quality healthcare can be as easily judged by healthcare consumers as by consumers of other services, and our tools help people rapidly improve quality. We can help remove waste from healthcare value streams as surely as we can from any other value streams.

But the missing element is the incentive to improve forced upon other industries by competition and easy access to information. In other industries, customers decide where to spend their own money and have to live with the costs and consequences of their decisions. They have access to frank and open assessments of others about their experiences with a particular supplier and the products and services they provide. They are free to move to a new supplier easily if they decide it is in their best interest to do so. None of these things hold true in healthcare. If we truly want to improve healthcare, in the sense of that we get higher quality service at a lower cost, then we need to address the root causes of the problem. Look at the proposed solutions to the healthcare crisis through this lens and ask yourself if they are treating the underlying disease or making it even worse.

GD Star Rating
loading...

Evil Process-FDA’s Broken Approval Process

Thursday, August 13th, 2009

Last night I watched a great movie, Living Proof, which documented a true story about a doctor struggling to get a promising breast cancer treatment drug approved. In one of the scenes the doctor has just completed a Phase I clinical trial and has to explain to one of the patients why she won’t be allowed to move on to the next phase. Essentially, the reason is FDA rules. For all practical purposes the woman is sentenced to death. She had responded favorably to the experimental drug, but not favorably enough to move to the next phase.

Ok, you might say. But surely she could be given the drug outside of the clinical trial, right? Wrong. She is denied access to the only medicine that could possibly save her, presumably in the name of safety.

This isn’t an isolated case. Because I’ve rented similar movies in the past Netflix recommends a host of other movies about people fighting heroic battles to get potential cures through the FDA’s approval process. In the article, Whose Life is it Anyway? former FDA commissioner Scott Gottlieb is quoted as saying that the FDA is failing to use its authority to strike a balance on this issue. Gottlieb suggests a number of process improvements. Too bad his suggestions probably won’t be taken seriously.

I’m one of the lucky ones. When I turned 50 I was diagnosed with severe Barrett’s esophagus. The standard of care is what could be termed “watchful waiting.” It involves periodic endoscopies and drug treatment. In my case, the drugs did no good and my condition got steadily worse. My checkups went from every two years, to every year, to every six months. The biopsies looked more and more like cancer, putting me and my family through periodic nightmares as we awaited the biopsy results. Eventually, I was sure, my condition would progress to esophageal cancer. Like most cancer treatments, the treatments for esophageal cancer are expensive, gruesome and ineffective.

Finally, after eight years of this, I spent my own money to buy 30 minutes of time with a physician at Mayo clinic in Scottsdale. As luck would have it, he had a clinical trial starting. I qualified, received the treatment, and am now completely free of Barrett’s esophagus. While I was blessed, my nephew’s father-in-law was less fortunate. His Barrett’s degenerated into cancer and he died during my clinical trail. It will probably be several years before the treatment is approved and made available to the public. In the meantime, more people will die.

The FDA’s drug approval process is over 50 years old. It takes years and costs hundreds of millions of dollars. Thousands die while the FDA slogs along. It doesn’t take Six Sigma or Lean training to see that this process is screaming for improvement. It just takes a heart.

GD Star Rating
loading...

My Prescription for the Healthcare Crisis

Thursday, July 16th, 2009

Thomas PyzdekInspired by Some questions not asked in health care debate – BizTimes.

Like many, I am concerned about healthcare in America. The above story outlines a number of issues with our system

  • A medical error rate 5 to 9 times higher than some other countries
  • Out of control healthcare costs

The author discusses the fact that Six Sigma has only recently been introduced in American healthcare, and then only on a limited basis. He details a horror story involving his father’s care and decries the fact that such stories abound. From this he concludes that the solution to these problems is…more government involvement in American healthcare.

I’m sorry, but I don’t get the connection. I agree with the above facts and would dearly love to have American healthcare professionals use more process excellence methods, including Six Sigma, Lean, and quality improvement. But I don’t see how more government addresses the root cause of our problems. In fact, I see little or no effort made to drill down to the root cause of the problems in healthcare. Let me make a stab at it.

  • I believe that government programs have contributed to the problem by helping create a disconnect between the patient and the healthcare provider.
  • I believe that the current system limits the choice of patients as to who will provide their care.
  • I believe that patients do not have access to the information they need to adequately assess the quality of their healthcare providers.
  • I believe that special interests (e.g., pharmaceutical companies, medical device companies, insurance companies, professional groups, etc.) manipulate government programs and limit access to information for their own advantage.
  • I believe that political groups use the fear of illness to manipulate voters for the interests of the politicians.
  • I believe that more government control of healthcare would exacerbate the above problems.

Solutions

I believe that solutions that address the disconnect between the person who provides the healthcare and the person who receives and pays for it will ultimately be needed to fix the problem. This is, I believe, the root cause of our current problems. An ideal solution would be one that:

  • Provides patients with complete, up to date, and accurate information on their provider. This would include information on outcomes, error rates, complaints, etc.
  • Allows patients to choose their care provider.
  • Provides patients with price data in advance.
  • Protects patients from paying for poor quality care, including any problems caused by misdiagnoses, complications from poorly done procedures, infections due to poor practices, etc.
  • Requires patients to pay at least some of the cost of their care directly to the provider. Enough to make the patient care about costs.

In other words, I believe more freedom and more responsibility for patients would address the core problem of the current system. I believe that when patients are free to choose their care provider, have complete information on quality and price, and have a personal interest in the cost of their care, they will make better choices than faceless and nameless bureaucrats employed by insurance companies or the government.

Not to lay the whole blame on government. I believe that the process and quality improvement professions have a great deal to offer the healthcare profession in the form of methods, tools, techniques and systems to improve. But healthcare professionals are overly resistant to such suggestions, at least party because of parochialism and perverse incentives. Examples of perverse incentives include physicians paid to treat complications they either cause or could have prevented, or hospitals obtaining revenues for patients whose length of stay increases because of infections contracted in the hospital. If patients were provided the information they need to make the right choices, the ability to make these choices, and the financial incentive to do so, intransigent providers would either improve or pay the price in the market for health care services. Ultimately, this would drive the demand for the services of quality and process improvement professionals. It’s what did it for every other industry in the world.

GD Star Rating
loading...

Get Certified!

Be trained by Thomas Pyzdek

Black Belt

Green Belt

Learn More!

Resources for Six Sigma


Introduction to Six Sigma
Six Sigma Projects
Six Sigma Tools
Six Sigma Statistics
Six Sigma Videos (Requires QuickTime)
Leading Six Sigma
Healthcare Quality
Process Excellence Podcasts
Other Useful Links
Good books on Six Sigma and other topics

What is Six Sigma?

By Thomas Pyzdek, Author of The Six Sigma Handbook

For Motorola, the originator of Six Sigma, the answer to the question "Why Six Sigma?" was simple: survival. Motorola came to Six Sigma because it was being consistently beaten in the competitive marketplace by foreign firms that were able to produce higher quality products at a lower cost. When a Japanese firm took over a Motorola factory that manufactured Quasar television sets in the United States in the 1970s, they promptly set about making drastic changes in the way the factory operated. Under Japanese management, the factory was soon producing TV sets with 1/20th the number of defects they had produced under Motorola management. They did this using the same workforce, technology, and designs, making it clear that the problem was Motorola's management. Eventually, even Motorola's own executives had to admit "our quality stinks." Read More...