Archive for the ‘Healthcare Quality’ Category

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

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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.
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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?

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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.

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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.

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My Prescription for the Healthcare Crisis

Thursday, July 16th, 2009

Inspired 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 tools, including Six Sigma, Lean, and quality improvement. But I don’t see how more government address the root cause of our problems. In fact, I see little or not 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.

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. 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. 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.

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Many Little Costs Equal a Big Savings

Tuesday, June 30th, 2009

This is a great article showing how lean is being used to reduce healthcare costs. The article points out that small costs add up. True. It’s the target of Kaizen, actually. We in the Six Sigma community often make the mistake of looking for projects that are “big hitters” and fail to recognize that a lot of small hits add up to runs on the scoreboard too!

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Medical Errors Cost Two Arms and Two Legs

Thursday, June 11th, 2009

Woman who lost arms, legs gets 2nd chance to sue doctors | www.azstarnet.com ®.

Lisa Strong had a history of kidney stones and suspected that the sharp pains she was experiencing was caused by yet another kidney stone. She told the ER Nurse this. But instead of treating the kidney stone the healthcare professionals responsible for Lisa’s care proceeded on a course of treatment that was to ultimately cost her both legs below the knees and both arms below the elbows.

Lawyers involved think so many mistakes were made the jury had a hard time fixing blame.

As an industry, healthcare has been remarkably reluctant to utilize the process improvement tools provided by Lean, Six Sigma, and other quality and process improvement methodologies. These technologies have proven to be extremely useful in defining and improving processes in a diverse range of industries. Indeed, I am personally aware of several successful applications of Six Sigma in healthcare. Results include:

  • A reduction in central line bacteremia infections from over 17% to under 1%.
  • A reduction in unnecessary Cesarean Sections resulting in reducing the over all C-section rate from 30% to 18%.
  • 98% of hypertension patients achieving control of their condition for a group of 50 PCPs. (The national average hovers around 30%.)
  • A DMAIC project that dramatically decreased time from arrival to initiation of Percutaneous Coronary Catheterization and Intervention. The new process meets recommended guidelines for nearly all patients.
  • Dramatic reduction in the number of Medicare patient hospital readmissions.
  • And many, many more.

True story: My wife observed her sister’s physician come into her room, shake hands with family members, then begin to change the surgical dressing on her sister’s wound. When she asked the doctor if he shouldn’t wash first he replied that it wasn’t necessary. (News flash for physician: it is necessary.)

Given the outstanding success of Six Sigma and other methods in improving the quality and cost-effectiveness of healthcare, it is a disgrace that the healthcare field continues to embrace outmoded approaches to healthcare delivery based on the “physician as magician” model. The costs in terms of dollars and human suffering is staggering. Let’s all hope that the profession sees the light soon and begins to take the  oath”First, Do no harm” seriously. Until they do, it is patient beware.

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Preventing Hospital Falls

Friday, June 5th, 2009

Hospital processes produce many things. Most of them are desirable outcomes, such as healthy newborn babies, new hip joints, cancer-free patients and blood flowing freely through once-blocked coronary arteries. In other words, happy, healthy and satisfied patients. These results are why health care professionals chose their field. They generate revenue that patients are happy to pay because the value they receive exceeds the cost.

But not all of the things hospitals produce are desirable. Hospitals also produce botched surgeries, surgical sponges sutured into patients, X-rays that must be taken repeatedly, falls, infections and many other unwelcome errors. These things also result from hospital processes, but because they are not part of the planned outcome, we tend to overlook the fact that they, too, are caused. Instead, many health care professionals look upon these poor results as unfortunate occurrences that appear without cause. Of course, they tend to accept these events as inevitable, which in turn assures continual recurrence.

The quality profession’s major contribution to the world is the ability to scientifically investigate process variation. This helps people see which outcomes, pleasant and unpleasant, are created by the system itself, and which are created by factors outside the system. Armed with this knowledge, workers can determine which action will most likely improve the process. Improvement can be an increase in the desired outcome, a decrease in undesired outcomes, improved efficiency or any combination of these. The approach is generic. It can–and has been–applied to improving health care processes. Let’s look at an example.

Falls. As I waited outside my father’s hospital room for him to finish dressing to come home, I heard a noise. The sound was distinctive: a body hitting the hard floor. I rushed in, a nurse close at my heels. My father’s elderly roommate lay on the floor, embarrassed as he tried to stand. The nurse and I helped him to his feet.

“I’m OK,” he assured us. “I leaned on the table, but it rolled and I fell.” He pointed to the small cabinet between the two beds. The nurse nodded as she guided him to the chair.

“That happens all the time,” the nurse responded. “They should replace those darned tables. They’re on rollers to make it easier to move them for patient access and cleaning of the room, but they cause a lot of accidents.”

Luckily, only the gentleman’s pride was hurt. But as I continued to wait for my father, I took note of the fact that the nurse continued with her rounds. If she ever reported the event, it was long after it occurred. Chances are it was never reported.

Later that day, I phoned the hospital and asked if they kept data on falls. “Of course,” I was told. “Hospitals re-cord everything.”

Not quite everything, I thought to myself as I recalled the event earlier that day. Probably anything that caused an injury. Only part of the story, but worth looking at in any event. The hospital faxed me the data on falls (see Table 1).

All organizations keep such data. However, it’s in a form that’s seldom used. The data contains information, but not in a format that people can easily interpret. To help us glean some knowledge from this data, let’s consider three statistical process control tools: the histogram, run chart and control chart.

A histogram shows the empirical distribution of the falls data. It would show that the number of falls reported each month varies from zero to six, with four falls per month being the most common. The number of falls appears to be fairly consistent; no months contain a great number of falls.

Where the histogram is a snapshot, the run chart is a movie. In Figure 1 we see the falls data stretched out over time. Applying statistical tests produces no significant data patterns. The run chart helps put the data in a context, which helps prevent misconceptions caused by looking only at a portion of the data.

While run charts allow us to examine patterns, they are less helpful in analyzing outliers or freak values. Control charts provide control limits that help do this. Creating a control chart of the falls data requires first determining the number of patient care days (PCDs) for the hospital each month. After all, one way to reduce falls to zero is to admit no patients! The U chart in Figure 2 shows reported falls per 100 PCDs. It also includes a centerline showing the process average and an upper control limit on the number of falls per 1,000 PCDs. Note that the UCL rises and falls as the number of PCDs changes.

The control chart shows that the rate of falls is “in control.” This means that if nothing is done each month, the hospital can expect to average about two serious falls per 100 PCDs. Some months no people will fall and hurt themselves, other months a half-dozen or more injuries might occur. That is, unless someone takes the time to look into the reasons why people fall. When management decides to do that, a whole host of techniques can be brought to bear on the problem, such as cause-and-effect diagrams and Pareto analysis.

And maybe, just maybe, those darned tables will be replaced!

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The physician as magician

Wednesday, May 20th, 2009

At the recent ASQ WCQI conference speaker Robert E Matthews stated that doctors are opposed to process in their hearts. Physicians are taught in medical school that it is the individual doctor that makes all of the difference in healthcare. Of course, the physician is a critical component of success. However, the physician is a member of a team. He or she works within a system that includes (we hope) a defined process, laboratories, pharmacists, nurses, physician assistants, patients, families, other care providers, payers, and a host of others.

Process excellence is, of course, the focus of this author. While it is but one of many factors, it is the one most often overlooked in healthcare. Robert Matthew’s presentation presented a case in point. While the national average for hypertension control hovers around 31%, Matthew’s case study showed that a group of 50 physicians were able to achieve levels of over 98%. The accomplishment had to overcome the perception that physicians were magicians capable of  achieving spectacular results without the need for a defined process. Once the group of physicians agreed to link their compensation to compliance with the mutually agreed to process, improvement to the unprecedented breakthrough levels was achieved.

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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...