Archive for the ‘Healthcare Quality’ Category

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

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.

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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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Health Care Industry Is Said to Commit to Holding Down Costs – NYTimes.com

Tuesday, May 12th, 2009

Health Care Industry Is Said to Commit to Holding Down Costs – NYTimes.com.a

No one questions the fact that health care costs are rising fast. Too fast, probably. Now that the industry has promised to join President Obama in controlling health care costs, I have a suggestion: do it smart. Mindless cutting of health care costs will result in loss of health care quality. Don’t just cut costs, be sure that you are cutting non-value added costs. The best tools for identifying these costs are Lean, Six Sigma, and Lean Six Sigma. To a trained expert in one of these skill sets a casual glance at any hospital reveals mind-boggling opportunities. We see waste everywhere in health care. From the batch-and-queue approach in the emergency departments, to the cumbersome admissions and discharge processes, in the medication errors and medical mistakes. And many, many other areas.

According to Mr. Obama

“These groups are voluntarily coming together to make an unprecedented commitment. Over the next 10 years, from 2010 to 2019, they are pledging to cut the growth rate of national health care spending by 1.5 percentage points each year — an amount that’s equal to over $2 trillion.”

The goal is admirable, albeit arbitrary. Nonetheless, it is a call to action that is long overdue. Let’s all hope, for the sake of our health and the health of our loved ones, that the spending cuts are the right ones.

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Continuity of Patient Care Decreasing

Thursday, April 23rd, 2009

Journal of the American Medical Association reports decreased continuity of care.

An article in the Journal of the American Medical Association (JAMA) reports that between 1996 and 2006, physician continuity from outpatient to inpatient settings decreased in the Medicare population. According to the article, in 1996, 50.5% of hospitalized patients were seen by at least 1 physician that they had visited in an outpatient setting in the prior year, and 44.3% of patients with an identifiable PCP were seen by that physician while hospitalized. These percentages decreased to 39.8% and 31.9%, respectively, in 2006. Greater absolute decreases in continuity with any outpatient physician between 1996 and 2006 occurred in patients admitted on weekends and those living in large metropolitan areas and in New England. In multivariable multilevel models, increasing involvement of hospitalists was associated with approximately one-third of the decrease in continuity of care between 1996 and 2006.

Continuity of Care Decreased Steadily Between 1996 and 2006

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Dear Doctor K

Monday, April 20th, 2009

When writing training materials for a general audience it is not possible to make examples that are tailored to a specific audience. One of my friends, a physician, commented that he thought the design of experiments exercise was too abstract. I wrote the following in response:

The example is for training a general audience, so it’s necessarily an oversimplification. As far as applications in healthcare, consider the randomized clinical trial. These are simple Designed Experiments. Usually they are one-factor-at-a-time (OFAT) experiments that attempt to isolate the effect of one drug across a population. Screening experiments would allow the assessment of multiple factors simultaneously with relatively small sample sizes. Since the OFAT approach is used instead, sample sizes are normally very large in RCTs. RCT designs predate the development of designed experiment theory and healthcare hasn’t adopted this more powerful approach.

Another application of DoEs could be bacteremia  infection reduction. Different protocols for handling CVCs could be tried. For example, different sterilization chemicals, different methods of applying the sterilization, different groups inserting the catheter (e.g., physicians vs. nurses,) different wait times from sterilization to insertion, etc.

Still another application might be readmission reduction. The experiment might investigate different discharge instructions, different follow-up protocols, different types of patients, etc.

Emergency Departments present numerous opportunities for experiments. Different staff schedules or staff mixes, different paperwork processing procedures, different ED layouts, etc.

In short, the screening DoE is useful whenever there are many factors we want to investigate to get an idea of which factors require additional attention. They help us improve the process right away by showing us simple, linear relationships. And they point us toward optimization by highlighting the critical to quality characteristics that require further study. There are many such situations in healthcare.

Designed experiments are controlled prospective studies. They are the gold standard for learning about process control and improvement.

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Why Isn’t Six Sigma Used More in Healthcare?

Thursday, April 9th, 2009

Apparently there are still questions about whether or not a process improvement methodology like lean or Six Sigma can work in healthcare. I find this astonishing and disingenuous. The only real requirement for deploying any process improvement is whether or not there is a process that is done more than once. Healthcare at any respectably sized organization involves thousands of patients, procedures, images, admissions, discharges, transfers, prescriptions, physician orders, medication administration, IV line insertions, laboratory tests. Need I go on?

Every time one of these things take place there are many ways they can go wrong. Patients can be misdiagnosed, emergencies can take too long to attend do, images can be poorly done or misinterpreted, admissions can be too time consuming and expensive, discharges can take place too early or without adequate instruction, transfers can injure patients, prescriptions can be issued in error or filled in error, physician’s orders can be incorrect or incorrectly interpreted or incorrectly followed, medications can be incorrectly administered, IV lines can become infected, lab tests can be done incorrectly or cost too much or take too long to do.

So, we have a very long list of clinical and non-clinical healthcare processes. For every process we have a very long list of things that can go wrong with the process, and an equally long list of ways in which the process can be done better.

Over 20 years ago the National Demonstration Project on Quality Improvement in Healthcare examined the applicability of quality methods to healthcare issues. They concluded

What is truly unique about the field of quality control is not its tools, but its ethos–the set of attitudes that it brings to quality problems.

Here’s a short list of what is included in this ethos

  • Prevention is preferable to detection.
  • Focus on the system, not the individual
  • The customer is central
  • Variation is endemic. Different types of variation require different types of responses
  • Quality should be defined broadly. It is not simply quality of care that matters, but also quality of service, amenities, reliabilitiy–all of the aspects of the healthcare encounter.

The NDP proved that the quality approach (aka Six Sigma and Lean) had value to the healthcare community, but there has never been widespread acceptance. I believe that the root cause of this is a system of perverse economic incentives that makes poor quality pay. A c-section poses higher risk to the mother and the baby. But whether or not a c-section is needed is a judgment call. If one is performed it costs several thousand additional dollars. Those dollars are revenue to the hospital and income to a physician, an anesthesiologist and other professionals and care providers. These are simple facts that can’t help but influence the decision-making process. When Six Sigma or Lean come along and promise to drastically reduce problems and system failures, it is only natural that the people involved consider the impact on their top and bottom lines. Until this situation changes, process excellence will be a tough sell in healthcare.

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