OP-ED

Could It Be That Patients Aren’t Any Safer?

On the occasion of last year’s tenth anniversary of the IOM Report on medical mistakes, I was asked one question far more than any other: after all this effort, are patients any safer today than they were a decade ago?

Basing my answer more on gestalt than hard data, I gave our patient safety efforts a grade of B-, up a smidge from C+ five years earlier. Some commentators found that far too generous, blasting the safety field for the absence of measurable progress, their arguments bolstered by “data” demonstrating static or even increasing numbers of adverse events. I largely swatted that one away, noting that metrics such as self-reported incidents or patient safety indicators drawn from billing data were deeply flawed. Just look at all the new safety-oriented activity in the average U.S. hospital, I asked. How could we not be making patients safer?

I may have been overly charitable. This week, in an echo of the Harvard Medical Practice Study (the source of the 44,000-98,000 deaths/year from medical mistakes estimate, which launched the safety movement), a different group of Harvard investigators, led by pediatric hospitalist and work-hours guru Chris Landrigan, published a depressing study in the New England Journal of Medicine. The study used the Institute for Healthcare Improvement’s Global Trigger Tool, which looks for signals that an error or adverse event may have occurred, such as the use of an antidote for an overdose of narcotics or blood thinners. Following each trigger, a detailed chart review is performed to confirm the presence of an error, and to assess the degree of patient harm and the level of preventability. While the tool isn’t perfect, prior studies (such as this and this) have shown that it is a reasonably accurate way to search for errors and harm – better than voluntary reports by providers, malpractice cases, or methods that rely on administrative data.

Using this method in a stratified random sample of ten North Carolina hospitals, the authors found no evidence of improved safety over a five-year period, from 2002-2007.

Before taking out the defibrillator paddles and placing them on our collective temples, it’s worth considering the possibility that the findings are wrong. We know that the Trigger Tool misses certain types of errors (such as diagnostic or handoff glitches; it’s worth looking at this recent paper by Kaveh Shojania, which emphasizes the importance of using multiple methods to get a complete picture of an organization’s safety), and perhaps the study overlooked major improvements in these blind spot areas. That said, the tool does capture a sizable swath of safety activities – and the lack of improvement in those areas is still disappointing.

I guess it’s also possible that these ten North Carolina hospitals are unrepresentative laggards. But North Carolina has been relatively proactive in the safety world, and these hospitals volunteered to participate in the study, an indication that they were proud of their safety efforts. While I would have liked a bit more information about the state of the safety enterprise at each hospital (did they have computerized order entry during the period in question, for example), I think the findings are generalizable.

Another slight caveat surrounds measurement and ascertainment bias. Because safety is far harder to measure than quality (the latter can be captured with measures like door-to-balloon time and aspirin administration after MI – and, as Joint Commision CEO Mark Chassin notes in Denise Grady’s article in today’s NY Times that reviewed the Landrigan piece, these types of publicly reported quality measures have been improving briskly), there is always the risk that things will look worse when people begin looking for harms more closely… which, of course, they must do to make progress. This is the fatal flaw when we think about using provider-supplied incident reports to measure safety. While the Trigger Tool is more resistant to this concern, it is not completely immune. For example, the hospital that is more attuned to preventing decubitus ulcers will undoubtedly examine patients more carefully during their hospitalization for signs of early bedsores. The Trigger Tool might mistakenly read these “extra cases” as evidence of declining safety. The same holds for falls: our new attention to fall prevention may cause us to chronicle patient falls more carefully in the chart. But such issues only raise concerns for the minority of the triggers; I can’t see how measuring administration of antidotes for oversedation and overanticoagulation, or 30-day readmission or return-to-OR rates, should be biased by a hospital’s greater focus on safety.

So, despite my best efforts at nitpicking, I’m left largely believing the results of the Landrigan study. Lots of good people and institutions have spent countless hours and dollars trying to improve safety. Why isn’t it working better?

I think the study tells us something we’ve already figured out: that improving safety is damn hard. Sure, we can ask patients their names before an invasive procedure, or require a time out before surgery. But we’re coming to understand that to make a real, enduring difference in safety, we have to transform the culture of our healthcare world – to get providers to develop new ways of talking to each other and new instincts when they spot errors and unsafe conditions. They, and healthcare leaders, need to instinctively think “system” when they see an adverse event, and embrace openness over secrecy, even when that’s hard to do. Organizations need to learn the right mix of sharing stories and sharing data. They need to embrace evidence-based improvement practices, while being skeptical of ones that seem like good ideas but haven’t been fully tested. And policymakers and payers need to create an environment that promotes all of this work – policies that don’t tolerate the status quo but steer clear of overly burdensome regulations that strangle innovation and enthusiasm.

In other words, the fact that we haven’t sorted all this out only seven years after the launch of the Good Ship Safety shouldn’t be too surprising. And my sense – although I can’t prove it – is that things are starting to improve more rapidly. Remember that the observation period in the North Carolina study ended in 2007. The first several years of the safety field involved skill building and paradigm changing. Some of the big advances in safety – the embrace of checklists, more widespread implementation of less clunky IT systems, mandatory reporting of certain errors to states, widespread use of root cause analysis to investigate errors – all began in the 2005-2008 period (and some, like IT, are really only cresting now). It will be crucial to follow up this study over time to see if there are signs of progress. I suspect the results will be more heartening.

What now? As I’ve noted many times before, I worry that a harmful orthodoxy has crept into the safety field. We need to figure out ways to ensure that we do the things that we know work, like checklists to prevent central line infections and surgical errors, fall reduction programs, and teamwork training. We need to develop new models for those areas that haven’t worked as well as we’d hoped, like widespread incident reporting and CPOE. We must do the courageous and nuanced work of blending our “no blame” model with accountability when caregivers don’t clean their hands or perform a pre-op time out. And we must allocate the resources, at the institutional and federal level, to do these things and study them to be sure they’re working.

The study by Landrigan and colleagues is a wake-up call. Let’s figure out what’s working, and do more of it. Let’s figure out what’s not working, and do something different. And let’s not stop until we can prove that we have made our patients safer.

Happy Thanksgiving to you and yours.

Robert Wachter, MD, is widely regarded as a leading figure in the modern patient safety movement. Together with Dr. Lee Goldman, he coined the term “hospitalist” in an influential 1996 essay in The New England Journal of Medicine. His most recent book, Understanding Patient Safety, (McGraw-Hill, 2008) examines the factors that have contributed to what is often described as “an epidemic” facing American hospitals. His posts appear semi-regularly on THCB and on his own blog, Wachter’s World.

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19 replies »

  1. Even i did go through the IOM Report and that was a set back for me as well. Everything has become a source of malpractice and hospitals are not far away.
    i would like to suggest to every reader regarding the website Findrxonlin, a sheer assistance for every patient as it has been for me.
    Regards,
    David.

  2. You can’t sell “reform” until you bash the system you which to “reform”. It has to be a very bad system. It has to need to be reformed and people have to be clamoring for any reform that promises to deliver. Never mind that the system really is not that broken and the promises made are pie in the sky.
    You can sell anything. Look at pet rocks, mood rings and bottled water. Don’t for get the Ford Pinto and the Chevy Vega and the Chevette. Why not EHR and why not the notion that we are not broke and can afford all this socialism BS.

  3. Hello Bob
    It sounds like you have changed your outlook a bit since we spoke in Keystone. The dearth of studies this year showing no safety improvement is certainly not a surprise to patients who have been harmed, nor do I believe it is a revelation to our physician community who witness the harm every day. A better question might be why we would expect patients to be any safer when physicians and nurses still work utterly insane hours. After 10 years we still cannot agree on the really simple things like the color and type of connectors IV tubes should have or what a standardized patient chart should contain. Perhaps during the past 10 years our system has be treating the symptoms of harm instead of digging deeper to find the root causes of our system failures.
    I would start the digging by linking several dozen claims databases from our largest med mal insurers to create a very comprehensive picture of nationwide harm. We could then identify the procedures, specialties, and physicians that cause the most harm. Step 2 would be to create a nationwide database of RCA’s to dig even deeper into the weakest system links. The process will undoubtedly find an abundance of issues which like you say may be really hard to fix.
    Personally I feel that one of our biggest root causes is that half of healthcare providers do not take patient safety seriously, specifically the male half. Go to any Patient safety conference and you will find 80% of the attendees to be women. Go to an infection control conference and you will find 90% of the participants to be women. Even among patient advocates the vast majority are women. Women cannot make this system safe all by themselves. Male provider/leaders must find the courage to step up and take responsibility for the failed outcomes and flawed systems which are far too common. Perhaps the current generation will never understand, but then we must find a way to instill in the 22 year olds in medical school that sharing their failures is far more important that maintaining some mythical reputation. We have to build a generation that truly believes from the bottom of their hearts “That just because medical errors happen does not mean that they must happen”!

  4. Good points by both of you. Lets find out what is being implemented and find out what works or what doesn’t. This is where transparency can deliver the best results. The JCAHO or The Joint Commission is a tremendous waste of manpower if it draws precious resources from Patient Safety. AS a outsider,I find them as part of the problem and a joke to deal with on most platforms.
    I do understand that these institutions are not only state wide but in many cases own Hospitals in several States. Which means that it would not be difficult to kill a career in a instant. So activist understand why they have to take a active role in speaking out and forcing the Admin to stand up for Patient Safety. The truth is Patients are not well represented either by the insurer and or the provider. The patient(member) is given a take it or leave it Policy,which only represents a contract between Insurer and Provider. It is this reason that patients need a Bill of Rights and a seat at the negotiation table. Patient Safety has been ignored for too Long and we need to put Safety First in the interest of cutting cost and saving lives.

  5. Maggie,
    I understand all that, but don’t you think it would be helpful and instructive to know what safety measures those hospitals had implemented over the years, so we can assess their effectiveness or lack thereof?
    Somehow just reporting that the level of errors has not decreased without reporting on what changed, if anything, seems ambiguous.
    Should one conclude that hospitals are not implementing safety measures? Or should one conclude that (some) safety measures are ineffective?
    An evaluation of the studied hospitals safety procedures and protocols could add a lot of value to the results here.

  6. The patient is not safe because the nurse has been neutralized by policy and by the computer she massages. Bedside care is in the hands of non-nurses. These people are not the keenly observant trained patient care specialists that nurses used to be. Unfortunately neither are new nurses the highly trained care givers that old nurses are (were).
    Nurses now bring policy to the bedside and leave the expertise in the past, since they are no longer allowed to use it.
    The sooner the JCAHO is scrapped the sooner will patients be safer.

  7. Almost everyone agrees that Medical Errors and Hospital Acquired infections are debilitating and Deadly for the Patient. Most Health Professionals agree that it is Bad for their Reputation and the Public’s perception as well. Lending to lies and cover ups that are supported by Medical Boards and State Investigators.
    Can we agree that something has to actively change to put a end to errors and infections?
    So how can we stop the eroding trust that Americans have in Medical Professionals and Hospitals?
    Public Transparency of infectious Rates and Medical errors would go a long way toward comparing Hospitals. The public chooses the Hospitals and Doctors of their choice.If you do not measure up , than you will have to raise the bar. This profession has enjoyed payment regardless of end results. Which is contrary to any Free Market Business Model. Your Patients demand results like any other business venture.
    We all know that Health Care’s primary mission has been hijacked. The investor and the insurers Have consumed all available resources. Leaving crumbs for the actual purpose of medical Care. To that goal, Patient Safety has suffured tremendiously.
    We find substandard Staffing Levels,in all departments, the fleecing of patients by subjecting them to extensive proceedures,that lend no Greater Results,subjecting patients to Medical Error from overworked Doctors and teams that need to stand down.Hospital Acquired Staph Infections that are preventable are due to the willful disregard to protect the patient from needless Harm.
    Although, the primary challange has been created by Insurers and Investors. Unfortunately,this places health care workers on the Front Lines to take on the challenges that Patient Safety Advocates Present. Please, understand we are protecting our own interests. So others do not have to experience Them.

  8. Almost everyone agrees that Medical Errors and Hospital Acquired infections are debilitating and Deadly for the Patient. Most Health Professionals agree that it is Bad for their Reputation and the Public’s perception as well. Lending to lies and cover ups that are supported by Medical Boards and State Investigators.
    Can we agree that something has to actively change to put a end to errors and infections?
    So how can we stop the eroding trust that Americans have in Medical Professionals and Hospitals?
    Public Transparency of infectious Rates and Medical errors would go a long way toward comparing Hospitals. The public chooses the Hospitals and Doctors of their choice.If you do not measure up , than you will have to raise the bar. This profession has enjoyed payment regardless of end results. Which is contrary to any Free Market Business Model. Your Patients demand results like any other business venture.
    We all know that Health Care’s primary mission has been hijacked. The investor and the insurers Have consumed all available resources. Leaving crumbs for the actual purpose of medical Care. To that goal, Patient Safety has suffured tremendiously.
    We find substandard Staffing Levels,in all departments, the fleecing of patients by subjecting them to extensive proceedures,that lend no Greater Results,subjecting patients to Medical Error from overworked Doctors and teams that need to stand down.Hospital Acquired Staph Infections that are preventable are due to the willful disregard to protect the patient from needless Harm.
    Although, the primary challange has been created by Insurers and Investors. Unfortunately,this places health care workers on the Front Lines to take on the challenges that Patient Safety Advocates Present. Please, understand we are protecting our own interests. So others do not have to experience Them.

  9. Margalit–
    Checklists and hand-washing are not enough to ensure patient safety.
    A surgeon should not be serving as the patient’s translator during surgery–he/she has other things to focus on. Someone who is not part of the surgical team should serve in that role. (And it should not be hard to provide a Spanish-speaking translator).
    The hospital should have a rule that the surgeon always must mark the site himself. (If a nurse or someone else is asked to do this, they should be told to speak up: “I’m sorry, but the surgeon is supposed to do this–it’s part of the patient safety mandate.”
    A time-out before surgery should be mandatory.
    There are systems that can reduce falls.
    Timers can be used to remind nurses that patients shoudl be turned (or that patients should turn themsleves) to prevent bedsores. (The most common, and as a result must expensive preventable medical error.)
    Hospitals should make sure that it provides adequate, trained staff to turn heavy patients.
    Hospitals are beginning to design processes that can support doctors, nurses and hospital workers in other ways– protecting them against their own inevitable fallibility as human beings.
    For examples, see http://www.ihi.org. (the insitute for healthcare improvement.)

  10. “Let’s figure out what’s not working, and do something different. And let’s not stop until we can prove that we have made our patients safer.”
    Let us be clear. CPOE and EMRs have NOT been working to improve safety. The report authors failed miserably by not reporting the penetrance of EMR and CPOE in their “White Paper”, and you Bob, ignore that matter.
    Prove what works has never been applied to CPOE and EMRs, albeit the latter is less malignant than the former.
    The safety breaches and adverse events occurring when care is directed by CPOE and EMR must be so attributed.
    Bob, stop serving kool aid.

  11. I didn’t see any information about the hospitals participating in the study. I think it would be interesting to know what safety measures, if any, they are already implementing. If they all use checklists and wash their hands religiously and have 100% CPOE adoption, where exactly do we go from here?

  12. There are countries that don’t have proper legal structure to protect patients.
    Patients in those countries assume that doctors are prone to make mistake and have greed factor. So they go for second doctor opinion and educate themselves. There is no greater cause for corruption or lackadaisical attitude than a lack of review.
    Action Items:
    1. Doctors to tell patients that they are mortals
    2. Payors to promote and pay for second opinion.
    Until a viable alternative is determined for patient safety maybe malpractice laws should remain. When providers/boards start voluntarily de-licensing doctors for malpractice, then we would know time for malpractice to go has come.

  13. I have experienced some of these issues first hand and althought Law Suites are the only avenue for Legal remedies. The percentages of Court Cases are very small incomparison to those who would sue for Medical Errors and Death. Furthermore ,a person would have collected very daming evidence before it would have a chance for trial.The facts are; not all patients have attempted to sue for medical error or Hospital Acquired Infections. Although, they have experienced a life altering event. Which Fiancially burdens the patient for something that is no Fault of their own! Let me remind you that Doctors or the institutions don’t pay for rescue or the additional expenses that are PREVENTABLE!
    “No fault of their Own” is a phrase that should be key to understanding why advocacy has been growing. Our mission is to turn all patients into informed Advocates to forgo being a victim of errors and staph Infections.
    Money is the largest factor in the Health industry and it appears that for some it is the only factor. Most of these mearsures suggested by the CDC are negligable and has shown much success with the Veterans Hospitals.
    It appears that Hospitals refuse to ballance patient safety with Profitability. Putting investors interests above the patients. Thus it is the patient that suffers from understaffing and it is the Patient that suffers from failures to implement and enforce ADI Procedures.
    If profit is all you care about then you missed your Calling.Patients are not expecting Doctors and Hospitals to do any more than your Jobs. We pay dearly for insurance and we are not getting what we pay for. Not when these institutions and professionals fail to recognize the threats and insist that the Status Quo is the concensus.Ignoring the concerns of patients to increase profits.

  14. How about a rating of “D”, as in Dumb or Delinquent? Below is a link to a Washington Post article from Friday 11/26 re Medicare payment issues leading to less care for the elderly.
    http://www.washingtonpost.com/wp-dyn/content/article/2010/11/25/AR2010112503638_pf.html
    I’m sure the usual suspects will find interesting deflections to blame physicians for this situation, after all, we took a vow of poverty per these spokespersons, right?
    Think about this, although said before, we turn to politicians to right a system that is supposed to be primarily based on compassion and empathy, yet, this is a group that does not understand, much less practice these beliefs.
    No, they pass legislation based on business models instead. Yeah, lots of compassion and empathy per those models.
    Again, you get what you pay for. Nickel and dime people, they go elsewhere for income. That is the business model you all are pining for in the end.
    Can’t have it both ways, people!

  15. Maybe I expressed myself poorly … Dr. Wachter wonders about the right balance of blame/pressure and nonpunishinh improvement efforts. I thought that the entirely dyfunctional medicolegal system could be used to that end (what else should it be for? The aim of the tort system should be actual improvement (by pressure to act responsibly and weeding out incompetent providers, shouldn’t it?). I agree that the current system is a lottery and that a lot of true negligence is not picked up. The current system produces a lot of defensive medicine, but fails to differentiate between negligent and nonnegligent care. And even even repeatedly and truly dangerous physicians can continue to practice by crossing state lines.
    “It is too bad that all the effort being made to secure tort reform isn’t instead being made to improve patient safety. That would not only reduce law suits but would also reduce injuries and save lives.” – to use an analogy, that reads to me like: It is too bad that people complain about unfair traffic citations and want to reform the system to punish the truly reckless drivers – efforts should instead be directed towards driver education and management, that would not only reduce tickets but also avoid accidents and save lifes. Does that make sense?

  16. Patient safety and not law suits should be the focus. The real problem is error and malpractice. According to the HHS IG, there are 180,000 deaths a year to Medicare patients from error. Yet in 2009 there were only 10,741 physician malpractice payments in the U.S., and only 3,528 of them involved patient death. In other words, there were over 50 malpractice deaths for every malpractice payment involving death. Obviously law suits aren’t the real problem; malpractice is.
    It is too bad that all the effort being made to secure tort reform isn’t instead being made to improve patient safety. That would not only reduce law suits but would also reduce injuries and save lives. Tort reform won’t do either of those.

  17. Interesting prospective about patient Safety. However,I’m not sure how Law suites became the main topic of Patient Safety. Tort reform has been the central motivator of Doctors to eliminate monetary losses. All it does do is permit the same medical errors and Hospital Acquired infections to rapidly encroach on patient safety without any accountability.
    Hospitals are far more deadlier today than 20 years ago. I do not know if it was the shifting of hospitals from patient Care to a Business model of I don’t care. It seems all of the short cuts taking to increase profitability, is cause for patients to beware.
    Patient Safety has been so neglected that medicare had to intervene by refusing to pay for never events. Events that should never occur in the Hospital and until recently,it has been largely ignored. Medicare has been for decades paying for medical Errors,Hospital Acquired Infections, falls ,Pressure sores, and a number of other preventable errors and infections.
    Of Course, Patient Safety and the incidence of medical errors have not been studied and/ or recorded.The Carolina Hospital’s are the tip of a greater and unsettling truth about their dirty secrets. Doctors often spend their time blowing off studies to discount findings but seldom promote transparency.
    To say that patient safety has not improved;is disappointing. Is like finding your Twinkies were stale. However, the gravity of inadequate Patient Safety is of grave Consequence and it deserves serious action.
    The truth is Health Care providers are resistant to change and it will be patients who advocates for themselves and others who will enforce the needed changes. Until then be forever vigilant to protect your health and persons from a fractured Health Care System.

  18. Dr. Wachter,
    I find it striking that you do not mention the legal system at all. I read your NEJM piece “balancing no blame” with interest and largely agreement, but I am stunned about the omission of the 10 pound gorilla-elephant in the room. The power of the legal system is acknowledged by almost every provider, and scares many shitless (a phenomenon I did not know from med school/residency involving 2 european countries)
    IMHO, the legal threat has to be completely redirected against true negligence. There are more than enough lawsuits that fault a physician’s cognitive abilities or judgment in a given situation, even though the law (most oftenm theoretically only) does not allow that
    http://www.acr.org/MainMenuCategories/about_us/committees/gpr-srp/MedicalLegalCommittee/MalpracticeWisconsinDecisionDoc6.aspx
    and even though it is established that physician reviewers are subject to hindsight- and outcome bias. Yes, many lawsuits like this do not succeed, but many end in settlements, and just a beginning lawsuit is an absolute threat to any provider (in terms of emotional and economic toll).
    My suggestions would be:
    1. As long as a provider treats a patient with a reasonable effort, he or she cannot be sued for malpractice. Several out of state independent practitioners of the same degree of specialization have to review the case (ideally, everyone would be blinded).
    2. If the reviwers agree on serious cognitive deficits by the provider in question, the patient will be compensated by specialty board insurance. The specialty board will also sanction the member, up to suspension/revocation of specialty privileges. (As a side note, there is no good reason why there shouldn’t be a well equipped, partially physician run federal board that oversees physician licensing – if you are a state right fanatic, one could still allow states to explicitely choose higher or lower standards than the federal one).
    3. If the reviewers agree on true negligence (e.g. not examining a patient, not reacting to a concerning test result), proceed with usual malpractice trial as we know it, but without involvement of partisan experts (or better, use health courts). And that’s how injuries should be treated arising from failure to adhere to safety measures (time out, checklists etc.)
    4. If the reviewers agree that there is system failure, victim compensation by the system’s insurance.
    That way, every component in the system has enough skin in the game to practice responsibly, and to improve constantly by dealing with problems.

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