Tuesday, November 29, 2016

Lean methodology and patient safety

A recent story in U.S. News & World Report described how a Seattle hospital is taking a systems approach in improving healthcare quality and cutting costs. It said, "Virginia Mason Health System...has looked to adopt many of the much-admired and often-emulated business philosophies from Toyota."

The best-known of those philosophies is the so-called "lean methodology" which is based on eliminating waste and focusing on things that add value.

Attempts to incorporate lean into healthcare have met with varying degrees of success. I blogged about this six years ago and pointed out that a literature review done back then found "significant gaps in the [lean and six sigma] health care quality improvement literature and very weak evidence that [lean and six sigma] improve health care quality."

Randomized prospective trials of lean in medicine are lacking. A recent paper from the Journal of the American College of Radiology found only seven studies on the use of lean in radiology and they showed "high rates of systematic bias and imprecision." The authors concluded there was "a pressing need to conduct high quality studies in order to realize the true potential of these quality improvement methodologies [lean and six sigma] in healthcare and radiology."

In addition to the debatable evidence that lean actually works and the cost and time to develop and implement lean measures, the use of Toyota as a model for quality is also highly questionable.

In 2010, Toyota had recalled more than 9 million vehicles for various defects. Nothing has improved. So far this year Toyota has recalled over 11,654,000 vehicles. The problems included exploding airbags, brake failure, fuel tank defects, and minivan doors opening while cars were in motion.

Having adopted lean methodology in 2002, Virginia Mason is not really a new story. How is it doing?

About as well as Toyota.

In May of this year, the Joint Commission paid a surprise visit to Virginia Mason Medical Center and found 29 instances where the hospital was out of compliance with standards. The Seattle Times wrote that among the problems were not having an adequate infection prevention and control plan, failure to store medication safely, and failure to provide a "care, treatment, services and an environment that pose[d] no risk of an immediate threat to health or safety."

On September 17, Virginia Mason regained full Joint Commission accreditation status, and 6 weeks later the hospital announced that it received an "A" grade for patient safety from the Leapfrog Group.

A hospital that failed a Joint Commission site visit because of multiple safety issues gets an "A" for patient safety in the same year? I discussed problems with the Leapfrog patient safety rankings in a previous post.

And if lean works so well in healthcare, can anyone tell me how does a hospital that has been practicing lean methodology for 14 years achieve 29 Joint Commission citations?


Blacksails said...

It remains to be seen if the joint commission surveys, leapfrog evaluations or flipping a coin is the best way to evaluate a hospital.

Skeptical Scalpel said...

I think the three you mentioned are all about equal.

JEN said...

My Health System spends soooo much time on LEAN. SO much.

Skeptical Scalpel said...

Jen, does that time expenditure accomplish anything?

Charlotte said...

From a person on the outside looking in, all these programs raise the numbers of admin people -- people who make lots of money -- and lower the amount of profit the institution shows. To bring the profit level back to sufficient (high) levels, actual care to and for patients must be lowered. The "health" in health care is based on the health of the corporation, not the health of the patients.

Anonymous said...

I agree with much of what you said however I would avoid using the Joint Commission citations as proof of true safety issues as much of the Joint Commission Citations and issues that I have seen as a resident have not been evidence based and JCHO rules seem to be there more to perpetuate themselves than to actually promote true patient safety

Skeptical Scalpel said...

Charlotte, good point.

Anon, I agree that many Joint Commission standards are nitpicking, but the patient safety standards are hard to ignore.

Anonymous said...

Despite its pompous tone and plentiful adjectives, I think this passage is revealing:

"...a pressing need to conduct high quality studies ***in order to realize the true potential*** of these quality improvement methodologies..."

I find it interesting that some subjects can exert a powerful grip on people's minds. Presumably the guy who wrote this would readily admit complete ignorance of, say, petroleum geology or Javanese grammar. But he does know the proper methodologies to manage each and every hospital and radiology department in the world.

William Reichert said...

I hope this adds to the discussion:
Several years ago, the subject of the QUALITY of health care was all the rage. The CEO of my hospital asked me to be in charge of
improving the quality of the care at the hospital.After thinking about this for a while I asked the CEO what health care quality was. He replied, "Your task is not to define it, just to measure it."

Skeptical Scalpel said...

Anon, great point. The believers in lean are cult-like in their worship.

William, I love that story. Were you able to measure that which was not defined?

frankbill said...

There is a Gov web site to help you learn what quality health care is http://www.ahrq.gov/

William Reichert said...

Was I able to measure it.? No, but we produced a myriad of studies demonstrating that we had plenty of it.For example we had
the neurosurgical group evaluate each other's care through chart review and guess what ? The concluded that they had lots of quality.
As far as the gov web site goes, they pick something that indicates the presence of quality. Let's say they decide good quality is present if patients have recommended colonoscopy
exams. But does this translate into lower colon cancer rates?
And even if the colon cancer rate falls does this translate into a longer life span.Moreover,If the health care system spends extra effort to get the colonoscopy rate up, does that mean they have fewer resources to treat diabetes or hypertension or pain.If the hospital has an electronic record that may be good but does this good come at the expense of reducing the amount of time the bedside nurse has to spend with the patient.?
What is the evidence that the health care system as a whole has
high quality. There are a lot of measurable events that appear to suggest quality but ,with limited resources, the improvement in one may result in a diminishment in another.What is the measure
of quality system wide? This is the elusive element that remains undefined. And may I suggest, it should remain that way.
In the same way that restaurants, movies, schools, cars,politicians and even beer elicit varying degrees of opinion regarding their "quality".

Skeptical Scalpel said...

I'm not surprised that members of a group rated their own quality as good. I agree quality is undefined.

Anonymous said...

Anonymous Europe: In order to do something "lean" in the health care industry, we need to throw out the bureocrats first and foremost, then the lawyers and all this "I need to cover my ass legally" style of treating patients.
Our lives would be way more relaxed, secure and stress free if we did not have lawyers and bureocrats stalking us....

Anonymous said...

I would throw out the leaders who are not like Paul Levy. The rest can go, get rid of the lawyers and just get people who can follow the law in terms of HIPAA, etc.

Agree though - very much so.

frankbill said...

Since this Seattle hospital thought Toyota's quality plan was a good one I thought I would share one of there plans.

I have a 2002 Toyota Tundra with 280000 miles. Book value around $5500. Now I like this truck it is about the best handling truck I have ever driven. How ever the frames on these trucks rust out as they due on Tacomas and Sequoias. Toyota is replacing the frames up to year 2008.They have done to my truck. They say the cost to do this is $10,000 each. At first they doing a buy back paying 1.5 times book value. This would have been a better deal for both toyota and me.

The problem is the frame manufacturer was using poor quality steel. You would thought that Toyota would have done some type of inspection of the steel before useing so many of them.

Skeptical Scalpel said...

Frank, yes you would think Toyota would have inspected the steel frames. I bet a kaizen addressed the problem. They still seem to have a lot of errors.

Mr C said...

Very interesting article. I became enthused about lean thinking many years ago when one of my colleagues instructed me and the third member of the Department to read the book. He could see the potential for improving things and put a proposal to the Department of Health in the UK to run a trial in urology. We were re-buffed but a year later they introduced a form of lean thinking that has permeated the NHS. To my mind, it completely missed the core concepts of lean thinking and I'm not surprised that it does not function in the forms that it has mutated into. Of course, the Virginia Mason medical Centre has been held up as a shining example of how successful lean thinking and American medical management is. Ho ho.

I went off and did the medical speciality aptitude test. Given that I trained as a general surgeon and then became urologist, practising for over 30 years and doing a bit of research on the side, I'm not sure whether number 10 is good or bad (general surgery was listed as potential career number nine and urology at number 10). According to the Virginia medical School, I should have become a nephrologist.

Skeptical Scalpel said...

I took that aptitude test about 5 years ago. It was fairly accurate for me. I blogged about it here http://skepticalscalpel.blogspot.com/2012/01/med-student-asks-is-surgery-right.html

Michael Brinton said...

Using JCo violations to complain about Lean Six Sigma in hospitals is ridiculous. After all, Six Sigma is a process improvement methodology. Although this can often easily transfer to higher quality of care, much of the effect of eliminating waste is felt more economically (provide the same service with less waste, therefore lower cost and/or increase profit!). Furthermore, many JCo policies have absolutely nothing to do with processes. For example, wearing OR scrubs outside the hospital can be a JCo violation, and yet I have seen innumerable people do exactly that at every hospital where I have worked.

That being said, as one familiar with Lean Six Sigma being applied successfully at one hospital, I can say that just because a hospital is attempting to use Lean principles does not mean that they will work or that results with be long lasting. Why? Because making processes more efficient means that people must change the way they do things. This is generally the biggest battle, especially with physicians who don't like non-physicians telling them how to manage patients (I know, I know, a non-physician can't tell you how to treat a patient, but they CAN tell you how you should organize your time). The attitude of this article where "there is no evidence to support X; therefore we should not do X" is also flawed. There are many medical recommendations that have no support in the research (even with a solid base of high quality studies), but physicians still give these recommendations. Why? Because there is anecdotal evidence to support them and no evidence that they will do harm.

To sum, do I think that Lean Six Sigma will, by itself, improve quality of care? No, but it is also not meant to to that. It is meant to make processes more efficient. On this note, I believe that Lean Sig Sigma principles can be applied in hospitals to help control the cost of medical care by doing exactly what it was designed to do: Add value and eliminate waste. Even this, though, will require everyone involved to buy into the changes being made. Doing something one way simply because it is the way that is has always been done is a terrible, counterproductive mindset that continues to plague many areas of medicine, and it is the exact mindset that often negates any positive effect that application of Lean principles may have had.

Skeptical Scalpel said...

Michael, thanks for commenting. The JC is quite process oriented. They don't care about outcomes. They just want you to wear a bouffant cap in the OR.

The harm of lean and six sigma is the amount of time and committee meetings that take place. It's time that could be better spent elsewhere. Also in many hospitals, expensive consultants are brought in to run these meetings.

If you want people to spend their time and money on this, you had better assure them that the effort is worth it.

Jeff Thompson said...

I agree with your premise that many of the quality improvement efforts emphasizing lean and other quality improvement methodologies often fall short. After having worked at multiple different healthcare organizations, I have seen both the good and the bad from various quality improvement efforts.

Ultimately, I think all stakeholders must commit to improving the value of care being delivered.

The successful organizations will develop meaningful quality improvement capabilities that are led by physicians and administrators with key leadership support from nursing, quality improvement professionals, IT, and other allied health staff.

Improvement efforts will need to focus more on large scale care redesign efforts that improve care delivery with meaningful results and improved outcomes.

This larger care redesign improvement work will be difficult requiring change across all levels, and yet it will be worth the effort. I can speak both from professional and personal experience that dramatically improving care delivery is possible and also very much still needed across our healthcare continuum.

Link to Example of Larger Scale Care Redesign Effort: http://content.healthaffairs.org/content/33/5/746.abstract

Skeptical Scalpel said...

Jeff, thanks for commenting and for the link. I'm not sure that what you have done at the Mayo Clinic can be duplicated at Elsewhere General Hospital.

Jeff Thompson said...

Agree that it will be difficult to duplicate and I am now trying to replicate outside of Mayo. Will be very challenging and yet I believe it is possible but not probable. Appreciate your blog and insights. We need leaders like yourself to promote meaningful improvement and change.

Skeptical Scalpel said...

Jeff, thanks for your kind comments.

frankbill said...

If William Reichert was at Dartmouth when the plane cashed on Moose Mt maybe he can tell us what changed there.

I only know from reading about this that not only did things change a Dartmouth but also changed how the whole area changed its emergency response system.

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