Two Kidneys and 100,000 Lives

This story about a kidney transplant mix-up in California is bound to get lots of coverage. It is these extraordinary cases that get public attention. I am sure it will lead to a whole new set of national rules designed to keep such a thing from happening.

Of course, such rules already exist, and it was likely a lapse in them that led to this result.

Nonetheless, we will “bolt on” a new set of requirements that, in themselves, will likely create the possibility for yet a new form of error to occur.

This kind of coverage and response is a spin-off from the “rule of rescue” that dominates decisions about medical treatment. We find the one-off, extreme case and devote excessive energy to solving it. In the meantime, we let go untreated the fact that tens of thousands of people are killed and maimed in hospitals every year.

Those numbers are constantly disputed by the profession. To this day, many doctors do not believe the Institute of Medicine’s studies that documented the number of unnecessary deaths per year.

And you never hear anyone talking about this 2010 report by the Office of the Inspector General, which concluded:

An estimated 1.5 percent of Medicare beneficiaries experienced an event that contributed to their deaths, which projects to 15,000 patients in a single month.

As the IOM notes, “Between the health care we have and the care we could have lies not just a gap, but a chasm.”

There is an underlying belief on the part of policy makers and public and private payers that the focus on quality is best addressed through payment reform. Let me state as clearly as I possibly can: That is wrong. It is a classic example of the old expression: “When you have a hammer, everything looks like a nail.” Changes in payment rate structures, penalties for “never events,” and the like can cause some changes to occur. Their main political advantage is that they give the impression of action, and their major financial advantage is a shift in risk from government and private payers to health care providers.But these are gross tools and will have unintended consequences. More importantly, they do not get to the heart of the problem, the manner in which work is organized in the highly complex environment of hospitals and physician practices. This is an environment in which ineffective work-arounds — instead of front-line driven process redesign — are the usual answer to obstacles in patient care.

They do not address the unmet education needs of doctors-in-training, training that is a throw-back to a cottage industry in which each person is expected to be an artist, relying on his or her creativity, intuition, and experience when taking care of a patient. The resulting lack of standardization — the high degree of practice variation — creates an environment that is inimical to process improvement based on scientific methods.

They do not address the documented advantages of engaging patients in the design and delivery of care, nor the power that such engagement brings to both doctors and patients.

Add to this the sociology of dehumanization in medical schools documented by Linda Pololi, and you have a stewpot of well-intentioned people destined to kill and maim others.

It is up to the medical profession, not the politicians or the insurance companies, to change this. First, though, they have to be willing to acknowledge that problems exist, that the current level of harm is not a statistically irreducible amount. The need to put aside the usual responses — “the data are wrong” — “our patients are sicker” — “our care is the best in the country” — and have the intellectual modesty to recognize that the real work has just begun.

To the extent the medical profession continues to abdicate responsibility, the more will step in politicians, regulators, and payers to do it for them. If you are a doctor and already feeling a lack of control over your professional life and your relationship with your patients, just wait.

I have previously quoted experts on this field, but the most cogent imperative remains the one provided by Ethel Merman:

Now what kind of an attitude is that, ‘these things happen?’ They only happen because this whole country is just full of people who, when these things happen, they just say ‘these things happen,’ and that’s why they happen! We gotta have control of what happens to us.”

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  1. Incidentally, I like the way you have structured your site, it is super and very easy to follow. I have bookmarked you and will be back regularly. Thank you

  2. Cory,

    We have now beat this horse to death. The numbers presented are actual numbers. Notice the reduction in mortality, too.

    But, I am not going to argue the numbers here. They are not the main point.

  3. Paul;
    Sorry – Put simply, I doubt seriously you did dropped the length of stay by simply reducing infections.
    That certainly could have played a role. No question. But you admitted 1500 more patients in 2009 than in 2005. Four more patients every day? You can tell me seriously that that was primarily the result of reducing infections? you can seriously tell me that admission policy/case-mix severity had nothing to do with that?
    How could you possibly know that without more info?
    Did you measure it?
    You didn’t build more ICU beds? you didn’t change post-op or preop policies? you didn’t change admission criteria? You analyzed severity of illness
    What are the other points I am wrong on? I looked at this for 30 years, I gave you some straightforward numbers that should be easy to verify? Nothing complex. Saving 100 deaths is an absolutely huge deal.
    But you chose length of stay only. Interesting. Didn’t mention deaths.
    Length of stay in the ICU is a function primarily of monitoring versus intervention – monitoring patients will have shorter lengths of stay than intervention patients- if you reduce infections you reduce length of stay. If you increase the number of monitoring patients, you reduce it more and in many more patients.
    These are serious and legitimate questions. they can be addressed scientifically altho it is quite hard to pin the answers down. They are by no means frivolous. The issue isn’t about change- everyone agrees there must be change- the issue is what change and how do you measure it.
    Dismissing the questions I have posed does not advance the issue at all. In the long run they need to be addressed, no matter what you believe about change.
    Simply telling me I am wrong without showing me (I am certainly willing to concede the point with appropriate analysis) is nothing more than begging the question

  4. Doc B;

    I implore you to read the book about Virginia Mason – its CEO is a physician and it addresses many of the fears you express. This is NOT about cookbook medicine at all. What you are seeing on your rounds is a mindless bastardization of the idea by the uneducated. That is why we must take charge of it and lead.

    And btw, 95% of the errors I chased were human, not equipment related. Many on the part of nursing or lab/nursing interaction. And in signing out surgical path slides I, too, was hostage to process errors, such as prostate biopsies from docs’ offices labeled with the wrong patient name, or lost by the courier, or mixed up patient ID from the OR. Or the time the nurse threw away an axillary lymph node dissection in a surgical towel. To err is human indeed, and it is only good systems, not yelling or exhorting, that will improve this performance.

  5. bev M.D.,

    The excerpt is correct.; “process redesign” is the answer. You’re arguing with the wrong person. I stated earlier that I do not tolerate errors. In your field, laboratory, with technical equipment and computer automation, your tolerance for error should be zero and that still is not attainable. Unfortunately, patients are human beings, not machines to be programmed or calibrated. There is no manual or “standard” for patients and therefore patient care.

    If patients were as your labaoratory equipment, we could simply read the manual to derive a correct result, or troubleshoot a specific problem. Diagnosis and treatment are based on the history from the patient (which changes minute to minute), examination, laboratory and radiologic test results; all with humans involved in their acquisition. It is that human piece that no process will ever change.

    Physicians rely on accurate information to make a diagnosis and prescribe treatment. If any piece is flawed, then an incorrect diagnosis is more likely to occur. Garbage in, garbage out. And if you were able to make humans infallable so that all errors were eliminated, none of us would be needed.

    Process improvement in the hospital setting is designed to make the possibility of the commission of errors less likely by telling the staff what to do step by step. Eventually with Medicare’s core measures, clinical pathways, treatment algorithms and the like, everyone involved in the care of the patient wil lose their critical thinking skills. It is already happening and evident on my daily rounds. Truly a sad day because your best and brightest will no longer choose medicine as a profession.

  6. Cory and others, Let me switch gears from the “data wars” and put it this way. This is about motivation and choosing to act. One of our bright young doctors put it this way:

    “I spent a tremendous amount of time thinking about what motivated us (“us,” here, being ICU providers) to work on a problem in a way that led to sustainable change. I came to the conclusion that – as a quality and safety professional – about 90% of my work was convincing people that there was a problem that was (a) common, (b) lethal, (c) expensive, and (d) improvable. Once everyone has agreed that there’s an urgent, common, lethal, expensive problem that we can prevent – but that we aren’t preventing — then the mind is focused and you suddenly have 1000 allies pushing you to rapidly change, instead of 1000 people you have to convince to change.”

  7. Oh, Cory, you are so wrong on so many fronts and are muddling cause and effect In short, the length of stay dropped because we reduced the number of infections in the ICU, not because of a case-mix change.

    But, look, the whole point of this is that there are ways to improve the work flow in hospitals, to reduce variation, to eliminate harm. Your quibbling — and I will call it that — about how to count the number of cases is not doing anything to help support the proposition that the profession needs to get to work on those items. You end up, probably without meaning to, being an apologist for the “these things happen” view of the world. This is not a PR deal. This is about lives of individuals.

    (P.S. I am not a doctor.)

  8. Bev:
    My point is you have to understand the numbers. Without that, you can not understand the effects of the interventions. And I think I can illustrate this using Dr. Levy’s numbers- I want to show you this is not semantics, nor quibbling over minutiae.

    Look at Dr. Levy’s graph- with that large patient base, I am going to assume this represents a combination of several multidisciplinary ICUs, probably in a university medical center. We are concerned with # of deaths prevented

    OK- # of deaths = (mortality rate) (number of patients)
    With me, so far? I am going to look at the numbers and estimate from the graph but the numbers look pretty close to round numbers.

    In 2005 they had 4500 patients, 12% mortality. That would translate to about 540 deaths.
    In 2009 they were up to 6000 patients 10% mortality. That would translate to 600 deaths.
    So at the time when they were supposed to have saved 100 deaths , they actually had 50-60 more deaths
    Now obviously that doesn’t mean they were doing anything wrong. More deaths is a function of more patients.

    But the assumption that they saved 100 deaths rests on the assumption that mortality would remain the same with more patients, i.e. with 6000 patients you would maintain a 12% mortality rate (you would expect 720 deaths).
    The problem with that is quite simple- anytime you see a drastic change in the number of patients over time (especially in an ICU population -and even moreso with post–op patients) , you have almost always changed the case-mix severity. This renders the concept of “deaths saved” a matter of speculation and often meaningless.

    In fact, when you see an increase of 20-30% in the ICUs of a hospital in a short time (as we did here), it usually means they are taking in more short-term, less severe patients (post-ops or monitoring situations). This is borne out by the documented shorter length of stay (admittedly your prevention efforts may have a role in that figure but case-mix is more often the determining factor). The idea that these patients have the same mortality as your initial cohort is obviously wrong.

    So they “saved” 100 deaths even though 60 more people died in the second interval. It’s pretty clear that the whole concept depends on a number of factors and that’s my point. You can do sophisticated analyses, make complex assumptions and do all sorts of extrapolations but in the final analysis, you have to look at the actual numbers. And quite often the numbers people give don’t jibe with the actual numbers. And that gives you a misimpression of your intervention. I think you can see why that might be important when we are talking about cutting down errors. We want our efforts to be the most effective and cost-efficient, not a PR deal.

    I would be willing to bet the decrease in mortality in Dr. Levy’s example was much more a function of case-mix severity (which is by the way easy to eyeball but hard to quantify) than VAP prevention. Out of those 6000 patients, there may have been some lives saved with VAP prevention and central line changes, probably were, but it was nowhere near 100 – I’m pretty sure of that. Had they not done those changes more than 600 people might have died – but 720 would not have.

    I hope I made it clear thru my explanation.

  9. Doc B:

    I suggest you read a book about Virginia Mason hospital in Seattle


    You have to get past the misleading title to the central point which is embodied in Mr. Levy’s quote:

    ,,,,, More importantly, they do not get to the heart of the problem, the manner in which work is organized in the highly complex environment of hospitals and physician practices. This is an environment in which ineffective work-arounds — instead of front-line driven process redesign — are the usual answer to obstacles in patient care

    It’s precisely that concentration on ‘fixing’ errors (the rescue approach he mentions above) which is insufficient – we must change the entire way work is done in hospitals and doc offices and then errors will be eliminated along the way. Wouldn’t you rather function in a smooth running system than constantly having to scramble to overcome a broken one?

    As a medical laboratory director who spent more than half my time chasing errors, I have become a convert to this approach – but has taken some years, an open mind and a lot of reading. This can be done – and the patients are demanding it. Wouldn’t you? A recent health scare with my 21 year old daughter and her encounter with the medical system brought it home even more forcefully for me. We all know the system is broken; let’s lead the fix.

  10. OK, cory but tell me – all the effort you put into documenting your comment up there would have been better used in process improvement such as at Virginia Mason to just fix the problem – which we know exists, however we want to quantify it.

    So what exactly is your point, other than that the data is wrong? What action items are you suggesting?

  11. Sorry for the lay question, but in those graphs, what part of the improvement in outcomes is attributable to process improvement and what part is attributable to advances in technology, drugs, devices, therapies, etc. which must have also occurred somewhere between 2005 and 2009? Can we somehow isolate the effects?

  12. Well, now, that comment seems like an orphan because a longer one that i left has yest to be published. Trying again here: Cory and Doc B,

    Please look here to see and example of VAPs avoided and decrease in hospital mortality rate at BIDMC. Likewise, other data are posted at http://www.bidmc.org that show the reduction in central line infections rate from about 4 per thousand patient days to almost zero. Pronovost showed the same in Michigan: http://runningahospital.blogspot.com/2011/02/our-patients-are-sicker.html These are real numbers based on real changes in the manner in which care was delivered.

  13. Cory and Doc B,

    Please look here to see and example of VAPs avoided and decrease in hospital mortality rate at BIDMC. Likewise, other data are posted at http://www.bidmc.org that show the reduction in central line infections rate from about 4 per thousand patient days to almost zero. Pronovost showed the same in Michigan: http://runningahospital.blogspot.com/2011/02/our-patients-are-sicker.html These are real numbers based on real changes in the manner in which care was delivered.

  14. Let me be clear – I am not trying to minimize the problem.
    I will give you an example -that 100 deaths number that Dr. Levy gives as an example. Do you know what a huge number that is?
    I worked at a large County Hospital for 30 years and reviewed every (yes, every death) in the Dept. of Medicine during that interval.There is a lot of give and take on “preventable deaths” and “errors” but I appreciate the problem. I dealt with mortality figures at several hospitals very closely
    But 100 deaths? that’s better than one every four days. 2 per week. I will state flatly there is no single intervention that does that.
    I am curious to see if Dr. Levy knows how many deaths occur in his hospital every year- I haven’t met five doctors in my whole experience who do. If its a large university hospital with trauma maybe one or two a day. If it’s a small community hospital, not even one per day.
    Decreasing central lines and preventing VAP- well I was an ICU physician -at our apex we had about 200 deaths a year in the ICU and I can tell you for certain half those people didn’t die because of VAP or central line infections (half didn’t even die with them). At least three quarters of those deaths were probably in terminal patients in retrospect. Unpreventable by any means. My best guess was that if we did everything perfectly in the ICU we could prevent 25 deaths per year -not a small number but nothing close to 100 – and everything would have to be perfect.
    Preventing 100 deaths in a single hospital in a year with any one intervention is just not within my realm of belief. I’m curious Dr. Levy exactly how many patients died in your hospital overall last year? Then plug that 100 number in.
    I am certainly for changing central lines and preventing VAP – but I would be surprised if that saved more than one patient a month in the ICU. That would be 12. I might go as high as 20 in a really busy ICU if you were really lucky (andI wouldn’t rule out less than 12 by any means).
    If anyone doesn’t believe me, before telling me I am wrong, give me the number of deaths in your hospital and ICU (and maybe adjust a bit for terminal no code patients on the wards). Let’s see what your actual numbers are and what 100 deaths in one year would mean.

  15. bev MD.,

    Not at all. Errors should not be tolerated, regardless of the outcome. But many studies, including the IOM and Healthgrades reports, suggest focusing our efforts on those errors that occur more frequently and with the greatest cost, both financial and from standpoint of loss of life.

    Other studies have looked at the overall outcome of true medical errors though clinical, not administrative, review of charts. Taking the review one step further, they asked whether or not the error committed would have resulted in the patient’s death if that error had not occurred. They found that the rate of death actually attributed to medical errors fell from 6% to 0.5%.

    Why don’t we concentrate our first efforts on the patients we can save in those areas where we truly can make an impact? While lives are being saved we can also be addressing those processes that need improvement.

  16. Doc B;

    I think once again you are missing the larger point. First, I don’t think Mr. Levy is targeting physicians as COMMITTING all the errors; he is challenging us to hold ourselves accountable to lead improvement. There’s a big difference.
    Second, who cares if we call it a medical error, or preventable harm, or never events, or whatever? The point is, it didn’t have to happen – and you wouldn’t want it to have happened to your family member.

    Unfortunately, we seem to be proving Mr. Levy right – instead of being part of the solution, we are part of the problem by trying to minimize the problem.

  17. Could this be just semantics? I have seen the examples cited above being classified as “complications” not “errors” per se. I think the key word here is “preventable”.
    If you were able to reduce deaths by 100 per year, and assuming you were not able to actually eliminate them, then there were at least 10 per month, or 2-3 per week. So, if the hospital sees on a local level such frequent numbers, why do we even need the IOM data to start doing something about preventable complications?

  18. The definition of a medical error is subject to interpretation and most studies use the definition that relates to their own perspective. A complete definition is: Errors or mistakes committed by health professionals which result in harm to the patient. They include errors in diagnosis (DIAGNOSTIC ERRORS), errors in the administration of drugs and other medications (MEDICATION ERRORS), errors in the performance of surgical procedures, in the use of other types of therapy, in the use of equipment, and in the interpretation of laboratory findings. Medical errors are differentiated from MALPRACTICE in that the former are regarded as honest mistakes or accidents while the latter is the result of negligence, reprehensible ignorance, or criminal intent.

    Mr. Levy sites ventilator associated pneumonia and central line infection as preventable medical errors which do not seem to fall into any category mentioned in the definition above. Those are both process related preventatives and mostly related to nursing, except for the use of sterile technique with the insertion of central lines by physicians.

    Despite best efforts, most all patients who are ventilated will eventually acquire a ventilator associated pneumonia. Infections with central access catheters increase with the length of time the catheter has been in place, the number of times the catheter is manipulated and the solutions, medication or nutrition infused through them. All without taking into consideration the overall health status of the patient.

    Under these circumstances, do they truly constitute “medical errors”?

  19. I find it incredulous and disappointingly ironic that the majority of posts here are focussed (as Levy points out) on questioning the numbers rather than examining our outdated and inefficient models for medical care. OK, lets say for the sake of argument that the numbers are off by 100 fold…this is still too much. Even if the iatrogenic complication/death rate is even lower than this, we owe it to our patients and our profession to strive for excellence particularly regarding those processes that are broken or can be improved.

    Our organization has created targets for ‘zero’ adverse safety events. Is this realistically achievable?..doubtful, but as Vince Lombardi said:

    “Perfection is not attainable, but if we chase perfection we can catch excellence.”

  20. So, to summarize, you don’t like their numbers. And then you say there is no way to figure out what the number actually is. Where does that leave us?

    These are not necessarily the kinds of deaths that would show up in M&M reviews. They are often deaths that result from the way work is done in the hospitals.

    At BIDMC, we were able to show the difference in mortality resulting from decreasing central line infections and ventilator associated pneumonia, just to cite a couple of examples. This was not a trivial number. Let’s say, order of magnitude, 100 cases a year of avoided deaths, compared to just a few years ago. Other hospitals who have engaged in such programs have seen similar results. Multiply by the number of hospitals in the country and you rapidly get up into the tens of thousands.

    So, you don’t like the IOM’s 100,000? What number would be small enough to say that we shouldn’t worry about the problem?

    And yes, the usual responses that I have seen are the ones I mentioned — “the data are wrong” — “our patients are sicker” — “our care is the best in the country”. The point is that these excuses, essentially number quibbling, do get in the way of getting the work done.

  21. “It is up to the medical profession, not the politicians or the insurance companies, to change this. First, though, they have to be willing to acknowledge that problems exist, that the current level of harm is not a statistically irreducible amount. The need to put aside the usual responses — “the data are wrong” — “our patients are sicker” — “our care is the best in the country” — and have the intellectual modesty to recognize that the real work has just begun.”

    OK, so you are apparently not allowed to doubt the IOM numbers, even though they do appear unreasonable/against common sense as cory pointed out, and even though there is valid (and peer reviewed, in high quality journals) criticism of the IOM numbers, many of them directed towards the problem of retrospective review (in other words, monday morning quarterbacking, also called hindsight bias).

    I have no other problems with Mr. Levy’s post – preventable medical errors do exist and need to be adressed. But his insistence on the need to accept the IOM estimates as fact (“Institute of Medicine’s studies that DOCUMENTED the number of unnecessary deaths per year.”) is simply intellectually dishonest. One wonders why he feels that there is need for such overstatement.

  22. One of the problems we have in health care is a lack of precise measurement of errors.

    Unlike air safety, many health care practitioners do not voluntarily report medical errors.

    Therefore, we are left with statistical sampling techniques to estimate the actual number of medical errors which are associated with patient deaths.

    They are estimates, but if the sample size is reliable enough, it provides a pretty good estimate of how bad the issue of medical errors really is.

    Until we have mandatory reliable medical error reporting, health care is living in the Dark Ages when it comes to applying best practices in quality control.

  23. The best thing we can do is get more precise numbers instead of extrapolations that make very little sense. Many errors lead to death,
    most errors don’t (as this transplant story indicates). There is no question that error prevention should be a priority.
    But numbers like the Inspector General’s defy belief. 15,000/ month is 180,000/year.
    Considering there are about 2.4 million total deaths, subtracting accidents, homicides, and suicides, roughly 2.2 million, if the IG numbers were right one in every 12 deaths would be accompanied by some medical error (and this assumes the IG report is considering all patients not just Medicare patients, in which case the percentage would be much higher).
    Just about impossible. When you consider all the people who do not die in hospitals or nursing homes (even accounting for those who may have wrong medication errors), the sudden cardiac deaths and the deaths form chronic diseases in the elderly or serious diseases in the newborns, it is literally impossible for 1 in every 12 deaths in the US to be accompanied by medical error without doctors, nurses, families, ward secretaries and plaintiffs lawyers being acutely aware of it every day.
    Every hospital in the US would be seeing at least one of these per week some four or five per week
    Doctors would be spending all their time in M and Ms and in depositions.
    This is clearly not the case.
    This is not to suggest there is not an unwillingness to see the problem or ignorance but no “cover-up” could be so big as to hide such a large number.
    I don’t know what the number of error related deaths truly is, the IG andIOM do not either. Their figures are based on extrapolations which do not pass the smell test. The number may be significant, probably is significant in the thousands ,but let’s do some real investigation at all our hospitals to find a good estimate of what that number truly is and what errors it represents.