A postmortem on the patient safety movement

Are patients better off than they were ten years ago?

Just over a decade ago the Institute of Medicine (IOM) released its celebrated report on patient safety, To Err is Human.  Many credit that report, which was released with great fanfare, with launching the patient safety movement.  So it’s appropriate to assess the movement’s impact eleven years later.  How did we do?

On November 25 the New England Journal of Medicine published a study on trends in patient harm during a six year period in the middle of the decade of the patient safety movement, with much talked about and disappointing results.  The report, which showed no improvement in treatment related adverse events over the study period, raises questions about whether the movement even had an impact at all.

I was not surprised at the findings and, in fact, blogged last year my opinion that the movement was a failure.  It’s appropriate now to examine some of the reasons.  But before we get too pessimistic lets acknowledge some positives.  Long before the birth of the patient safety movement the field of anesthesiology had made great strides, implementing systems improvements which markedly reduced  the rate of perioperative complications.  And in the decade just past there were a couple of isolated success stories, namely the use of check lists to reduce central line infections and perioperative complications.

So why has the movement has so little impact overall?  To answer that question it is helpful to examine more closely its history.  In its 1999 report the IOM claimed that 44,000 to 98,000 Americans were killed in hospitals each year as a result of medical mistakes.  But the IOM’s methods were not transparent and its analysis was suspect.  A spate of scholarly articles soon challenged the findings.  The lead author of the Harvard Medical Practices Study, on which the IOM’s figures were largely based, even wrote an editorial expressing regret about how the findings of his study had been distorted.  Even patient safety leader Robert Wachter, one of the biggest boosters of the IOM report, admitted that it was a remarkable piece of spin.  But it didn’t matter.  The notion that hospitals were killing up to 98,000 Americans each year took on a life of its own.  To borrow an expression from Wallace Sampson (who was writing about the widespread acceptance of unscientific complementary and alternative medicine) “with the press wowed and the academics cowed” the horse was already out of the barn.

The myth of 98,000 deaths from medical mistakes was perpetuated, and with far reaching negative  consequences.  The IOM report and the ensuing media hype paved the way for implementation of Medicare’s no pay for adverse events policy, in which often unavoidable complications, such as patient falls and pressure ulcers, were administratively defined as medical errors.  The culture of patient safety soon morphed into a culture of provider blame.  Even the trial lawyers took notice and adopted a new legal standard for adverse events.

Patient safety experts have told us that a blame free atmosphere where transparent, open analysis of adverse events can take place is essential to an effective systems approach to patient safety.  The IOM report backfired.  It had the opposite effect, producing a culture of blame in which any adverse event is someone’s (and hopefully someone else’s) mistake.  What is ironic is that many of the IOM’s own recommendations were based on a blame-free culture of transparency.  It’s little wonder, then, that a Consumer’s Union report from last year found that almost none of them were carried out.

So are patients better off than they were a decade ago?  Yes, thanks to medical progress and innovation which year by year make us smarter and offer better options for diagnosis and treatment.  What about the future of the patient safety movement?  It may yet succeed, but first medical experts and policy makers need to perform a root cause analysis on the failures and missteps of the past decade.

Robert Donnell is a hospitalist who blogs at Notes from Dr. RW.

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  • Marc Gorayeb, MD

    The days of pathology grand rounds, morbidity and mortality meetings, truly serious medical grand rounds, and even effective quality assurance committee meetings are over. Why? Fear of litigation. It’s that simple. During my time as a student and resident, these meetings – open to medical and nursing staff – were frequently used to discuss and analyze flawed decision-making and system errors.

    Not only has there been no substantial improvement in ‘patient safety’ programs, it is arguably worse. Not only are there legal reasons not to openly analyze errors, there are now bureaucratic reasons as well. What about the terror that JCAHO now visits upon hospital administrators, and, by extension, nurses and physicians? It is currently a game meant to obtain ‘accreditation’ as quickly, cheaply and painlessly as possible. Too much economically rides on the outcome of this bureaucratic kabuki dance to permit truly effective quality improvement.

  • http://www.drjshousecalls.blogspot.com Dr. Mary Johnson

    The thing is, in our “blame-free” culture, sometimes badness IS someone’s fault – and “punishment” is warranted. We’re not going to get tort reform until some figures that out – and incorporates that into the bigger picture.

    Patients simply are not going to buy it. And having been on the wrong end of surgical malpractice myself (not once, but twice), I, as a patient, do not blame my fellows.

    The problem with our system is that, more-often-than-not, hospitals work overtime to cover badness up – and the messengers (i.e. the people who intervene to STOP patient harm – or report it) get shot.

    What happened to me as a doctor happened twelve – almost THIRTEEN years ago. I’ve been blogging about it for FIVE years. But somehow, NONE of the “oversight” agencies that were supposed to care about – and “oversee” patient safety (JCAHO, DHHS, the NCMB, the IRS, etc.) did ANYTHING to address it. The media has turned a blind, disinterested eye.


    There is considerable way-bittersweet irony in this study for me – in that it was conducted using randomly-selected hospitals in North Carolina.

    This report doesn’t tell me anything I didn’t learn the hard way a very long time ago.

    And all the right people will talk about it and wring their hands and do a whole lot of nothing.

  • http://www.meyersmedmal.com Jivanmeyers

    One can’t solve a problem without learning the cause. if the cause involves human conduct and the problem was preventable and should have been prevented, repetition is inevitable unless the responsible person accepts responsibility. This process is elementary problem solving not a blame game.

    • John Ryan

      Taking the “elementary problem solving” one step further usually finds, besides the human making the error, that the error was preventable. If we assume that people can be expected make errors, then the process of error prevention should not merely blame the sinner, then walk away smugly. We should analyze what process could prevent a patient injury when the inevitable error is made. This is not a “blame free culture”, it is a method of making sure the errors we all make don’t hurt anyone.

      I certainly agree, however, that the likely reason that there has been no improvement in patient safety is the legal and regulatory fallout from opening errors to public scrutiny. The “spin” on the IOM’s 98,000 deaths killed patient safety in its infancy.

  • http://www.drjshousecalls.blogspot.com Dr. Mary Johnson

    Jivan, Dr. Gorayeb is absolutely right . . . as “responsiblity”, in our lawyer-drenched, sue-happy world, usually translates into money.

    That generally translates into either (1) find a scapegoat and pound, or (2) kill the messenger and hide.

  • Primary Care Internist

    From what i understand about the IOM a situation like this would be regarded as a medical error resulting in an avoidable death:
    85yo nursing home resident admitted to hospital with septic shock from multilobar pneumonia and staph bacteremia, febrile to 102 and with wbc around 25k; placed on iv abx etc., and given tylenol prn for fever; gets 1000mg instead of 650mg of tylenol for one particular dose despite the 650mg having been ordered. Dies a couple of days later.

    Now i could be wrong, but i’m guessing the patient did NOT die of that tylenol “overdose”. And generally such types of errors are really system errors, rather than errors on the part of the MD himself.

    • John Ryan

      Exactly. And this was found time & again when the original reports cited in the IOM report was carefully reviewed. But by that time President Clinton had already announced he was going to solve the problem with money & government agencies, so we never heard the facts.

  • gzuckier

    “often unavoidable complications, such as patient falls and pressure ulcers, were administratively defined as medical errors”

    I hope you’re parsing this as “patient falls and pressure ulcers are often unavoidable” rather than as “often; unavoidable complications such as patient falls and pressure ulcers”

  • http://doctorrw.blogspot.com/ Robert W. Donnell

    Of course. Sometimes avoidable, but can never be zero even with exemplary care.

  • doctor

    Referred to this blog from Kevin MD. Comments are right on target. I always questioned the sensationalist aspects of the IOM report as well.

  • http://www.meyersmedmal.com Jivanmeyers

    Do you also ignore the recent published studies indicating that the incidence of harm remains unchanged.

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