Mandatory reporting of diagnostic errors: “Not the right time?”

27 Sep

by Carolyn Thomas    @HeartSisters

I can’t be 100% certain, but I’m betting my next squirt of nitro spray that the Emergency Department physician who misdiagnosed me with acid reflux and sent me home despite my textbook heart attack symptoms (central chest pain, nausea, sweating and pain down my left arm) did NOT voluntarily report his diagnostic error to his supervisor or to anybody else after I was correctly diagnosed much later by a different emergency doc.

I’m also betting that he, being a smart person with the letters M.D. after his name, had a pretty good idea of the definition of the term “diagnostic error” (even I know that this means an inaccurate or delayed medical diagnosis). Second, he was very likely fully knowledgeable about how diagnostic errors can hurt patients like me. And thirdly, it was probably not too hard for him to assess the precise outcomes of such an error (patient sent home from Emergency despite textbook cardiac symptoms, thus delaying appropriate treatment for what doctors still call a widowmaker heart attack).

Yet those three excuses are what we’re offered to explain why mandatory reporting of diagnostic errors is not among the eight key recommendations in the Institute of Medicine’s new report called Improving Diagnosis in Healthcare. (You can order a hard copy of this impressive 346-page IOM report, read the report online free, or check out the 4-page Report In Brief version).

At least twice during the report launch briefing event I watched live on my laptop screen this week, I heard this excuse voiced by the committee chair:

“Now is not the right time for mandatory reporting of diagnostic errors.”

The full report explains this troubling stance by claiming three things:

  • there had been no agreed-upon definition of diagnostic error prior to this report
  • there is not enough data on diagnostic error
  • it is hard to measure outcomes to collect such data

But my question to the IOM committee that came to this conclusion is this:

If now is “not the right time for mandatory reporting”, when might that right time be?

The impact of getting a wrong diagnosis is staggering. The report warns, for example:

“Diagnosis – and, in particular, the occurrence of diagnostic errors – has been largely unappreciated in efforts to improve the quality and safety of health care.

“The result of this inattention is significant: most people will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences.

“Urgent change is warranted to address this challenge.”

“Urgent change”, however, does not apparently include a recommendation to start requiring health care professionals to report diagnostic error.

Instead:

“Voluntary reporting efforts should be encouraged and evaluated for their effectiveness.”

Allow me to translate that for you, dear reader:

“Somebody should do something about this. Some day. Really . . .”

The IOM report politely observes that, despite numerous calls for change, “efforts to improve voluntary reporting and analysis at the national level have been slow”.

Why not, then, a strong recommendation for mandatory reporting of diagnostic errors, and why not now?  

Many studies have been published on the question of why health care professionals all over the world have been so “slow” to voluntarily come forward and report their diagnostic errors (1).  For example:

“The main reasons for not reporting were fears that junior staff would be blamed, high workload, and the belief (even when an incident was designated as reportable) that the circumstances or outcome of a particular case did not warrant a report.

A study(2) on under-reporting of adverse medical events blamed powerful disincentives to impose mandatory reporting. (Translation: “You can’t make me!”)

We already know that complex non-medical industries have long had effective incident-reporting systems in place to protect the public, although in the early days of mandatory reporting, one can imagine that industry types also protested: “Oh, now is not the right time!”  One study(3) compared reporting of misdiagnoses and other adverse medical errors to other real-world expectations in the field of public safety, concluding:

“The situation is like that of the field of injury control, where until there was focused public attention and demand for action on injuries and their prevention, injury remained a neglected health problem.”

That shift towards mandatory reporting when bad things happen in order to protect public safety explains why we no longer have voluntary hard hat usage on construction sites, or voluntary speed limit rules on our highways, or voluntary safety checklists by airline pilots before takeoff. 

Yet when it comes to making our medical care safer, we are being told that now is somehow not quite the right time for mandatory reporting of diagnostic errors.

The IOM’s puzzling reluctance to walk the bold talk seems to contradict its own 1999 To Err is Human report on preventable medical errors(4).

In this groundbreaking report, the IOM emphasized the importance of reporting errors, using systems to “hold providers accountable for performance,” and “provide information that leads to improved safety.” 

That 1999 report also referred specifically to both serious errors that resulted in deadly outcomes, as well as three types of potentially serious errors that (as in my own misdiagnosed heart attack) are caught in time to ward off deadly outcomes.  Committee authors insisted at that time that the reporting of potentially harmful errors that were intercepted before harm was done, errors that did not cause harm, and near-miss errors is “as important as reporting the ones that do harm patients.”

So let’s put a human face to that reality.

Let’s imagine that the hospital that had sent me home with an acid reflux misdiagnosis had in place a policy that suggested its staff could (if they felt like it) voluntarily report such a diagnostic error as soon as that initial error became known to them (i.e. when the patient was later readmitted to the E.R. for a correct diagnosis/treatment, or was found dead at home of a heart attack).

But hey! I’d survived that heart attack despite being misdiagnosed during my first trip to the E.R.  I hadn’t died. I was still alive. So really, what’s the harm?  What’s to prevent Emergency personnel from deciding that the circumstances and outcome of my case did not even warrant a report?  Case closed.

That diagnostic error never happened, because it was never reported.

Now let’s imagine that a mandatory reporting protocol for diagnostic error had been in place that day (regardless of circumstance or outcome). As soon as the Emergency medicine personnel during my second E.R. visit realized that I’d been previously misdiagnosed, a mandatory protocol would have helped staff report that this patient had been sent home earlier because of a diagnostic error. 

Mandatory reporting of diagnostic error is all about specifically attempting to safeguard the health of future patients.

Had that hospital endorsed mandatory reporting, it would have meant that the next time my ER physician has another middle-aged woman presenting with significant heart attack symptoms but “normal” cardiac tests (a surprisingly common occurrence for female heart patients), he just might remember my own case and hesitate before sending that woman home, just another middle-aged woman making a big fuss over a little indigestion.

This focus on preventing future events happens in exactly the same fashion that workplace safety, highway safety, and aviation safety protocols that enforce mandatory reporting of errors are seeking to protect future victims of those errors, too.

How can anybody, anywhere claim that patients do not deserve the same attempts at protecting us, too?

And what can patients do to help protect ourselves from being the victims of diagnostic error? Researcher Dr. Hardeep Singh, one of the physicians who served as an expert reviewer on the IOM report, had this suggestion during a Wall Street Journal interview:

“They could be strong partners with their doctors. Patients should always check on their own test results, regardless of whether they have heard back from their doctor or not. So no news is not necessarily good news.

“Second opinions are often suggested as potential interventions to reduce misdiagnosis. In one of our studies, second opinions changed diagnosis around 15% of the time and treatment about 37%. That’s a pretty big impact.”

Meanwhile, as the award-winning ProPublica journalist Marshall Allen (most recently of Surgeon Scorecard project fame) warned his audience at Stanford University’s Medicine X conference this past week:

“Until you start measuring something, you can’t improve it.”

IOM crew setting up
IOM camera crew setting up in my living room

Full disclosure:

I was interviewed by the IOM during this summer’s production of a short video (6:49) that accompanied the launch of their new report, Improving Diagnosis in Healthcare.  The video features three people affected by diagnostic error; mine was the first patient story in the video (note that the video was unfortunately edited to make it appear that my only heart attack symptom was “pain down my left arm”, which is inaccurate; other symptoms included textbook central chest pain, nausea and sweating).  Although feedback about this video project has been warmly positive, I’d like to acknowledge the American College of Emergency Physicians and their Twitter followers, some of whom objected to several parts of the IOM video.  Some felt defensive about what they interpreted as blaming Emergency Medicine for diagnostic error; they claimed that diagnostic error is mostly due to all those other medical specialties (like radiology). For women experiencing heart attack, however, E.R. staff are indeed the gatekeepers between us and appropriate cardiac care. 

Q:  Are there good reasons for NOT recommending mandatory reporting of diagnostic errors?

See also:

(1) Vincent C. Reasons for not reporting adverse events: an empirical study. J Eval Clin Pract. 1999;5:1–9.
(2) Paul Barach et al. Reporting and preventing medical mishaps: lessons from non-medical near miss reporting systems. BMJ. 2000 Mar 18; 320(7237): 759–763.
(3) Haddon W Jr. Advances in the epidemiology of injuries as a basis for public policy. Public Health Rep. 1980 Sep-Oct; 95(5):411-21.
(4) Institute of Medicine. To err is human: building a safety health system. Washington, DC: National Academy Press; 1999.
.

14 Responses to “Mandatory reporting of diagnostic errors: “Not the right time?””

  1. Jennifer October 2, 2015 at 8:28 am #

    I too had a delayed diagnosis. First it was delayed by my refusing to accept that I needed to go to the hospital, despite severe dizziness and shortness of breath. At Emergency I was taken seriously because I have a medical history of two cardiac valves replaced with artificial valves as well as asthma.

    However, despite being observed overnight and examined by three non-emergency doctors, including one from pulmonary and one from cardiology who did a Dopler ultrasound of my heart, nobody knew what was causing my symptoms.

    Since my cardiac history was most remarkable, I was sent to bed on a Cardiology floor in the morning. It was Saturday, so the nurses took my vital signs every four hours, but no MD saw me.
    Sunday morning the cardiologist who was responsible for me made rounds and introduced himself. When he heard my story he organized an immediate TEE (Trans Esophaageal Echocardiogram), which revealed that I had clots on both of my artificial valves. The clots were large and were waving back and forth with the flow of blood, even as they impaired the flow.
    I was immediately admitted to the ICCU. If part(s) or all of a clot or clots broke off, I would have a pulmonary embolism, stroke(s) or a combination.

    Now I was the centre of attention! After much consultation and research, the decision was made to give me a clot busting drug, as is used right after strokes, with careful monitoring of neuro signs (has a bit of clot been nibbled free and gone astray?) every 15 minutes during the 4 hour IV dose and for many hours(days?) after, plus high dose Heparin to keep the process going for several weeks. At some point warfarin was added. It’s my usual anti-clotting drug.

    Nearly a month after I reluctantly presented myself at the ER, I was discharged home, weak but well, with stricter conditions regarding my daily warfarin doses and testing of my INR.

    Liked by 1 person

    • Carolyn Thomas October 2, 2015 at 9:12 am #

      Thanks for pointing out that delayed diagnoses can be caused by both the patient AND the health care team! Failing to order the TEE upon admission was likely the culprit in your delayed in-hospital diagnosis. Could have been a fatal mistake. I’m guessing that nobody at that hospital voluntarily reported the diagnostic error…

      Like

  2. Curious to the Max September 27, 2015 at 3:25 pm #

    Elvira brings up a very good point. Society has become far too adversarial and litigious. When the fear of being reported or sued is removed, the climate might change.

    When I was in practice as a therapist, the threat of being reported and/or sued was ever present. Over the years it led to my being very selective about who I would and would not see. I was not dealing with physical life and death matters so I can only imagine what that threat is like for medical doctors.

    I don’t know what the solution is regarding reporting “mistakes”, particularly those which are life-altering at best and life-threatening at worst.

    Liked by 1 person

    • Carolyn Thomas September 27, 2015 at 5:22 pm #

      Hello Judy-Judith! Threat of being sued (particularly in the U.S, far less so here in Canada) seems to be the big boogey man in the closet for so many health care professionals. Yet a number of studies have suggested that doctors should not view litigation solely as a legal and financial problem. One U.K. study, for example (Vincent et al), found that failure to provide information, an explanation, and an apology actually increases the risk of litigation and erodes the patient-doctor relationship. I wrote more on this in Why Doctors Get Sued

      Like

  3. Andrea Rosenhaft September 27, 2015 at 1:14 pm #

    Carolyn
    During that first ER visit, I recall saying to the triage nurse that I thought I was having an asthma attack. I had been to my pulmonologist the day before because I thought I was having a flare-up of my asthma, and apparently he agreed because he started me on a course of oral steroids. I had been struggling with the asthma since June when I had been hospitalized for a severe attack and had been on oral steroids almost every week.
    So who would have thought otherwise? Especially the first night – or until my symptoms didn’t resolve with the aggressive treatment provided that evening.

    So you are correct. My remark – and my history at that particular hospital – where I have received most of my emergency asthma treatment – most likely influenced that ER doctor’s course of treatment. I couldn’t imagine that it was anything else.

    Liked by 1 person

    • Carolyn Thomas September 27, 2015 at 5:12 pm #

      No wonder you suspected an asthma attack, Andrea! And all of that background you offered the staff (in your comment below) re your June hospitalization, new course of steroids etc – all must have contributed to the ER doc’s relative certainty that he was dealing with a diagnosis of asthma, not pulmonary embolism – especially in the absence of a correctly interpreted chest x-ray. Best of luck to you – I hope you’re feeling better by now…

      Like

  4. Andrea Rosenhaft September 27, 2015 at 10:02 am #

    I went to the ER on the Wednesday evening before Labor Day with shortness of breath and chest pain for what I thought was an asthma attack. The doctor treated me aggressively for asthma and sent me home, but the next day I was still short of breath and dizzy.

    The nurse from my company’s Wellness Line encouraged me to return to the ER, which I did. The ER doctor (a different one) admitted me because I was having such difficulty breathing and the admitting doc (almost as an afterthought) did a CT scan with contrast of my chest because although my D-Dimer level was normal, I was on hormone replacement therapy. I was sent up to a room about 2 AM on Friday morning. It was not until 2 PM on Saturday that the hospitalist came into my room and told me I had a pulmonary embolism – that was because the first radiologist who had read the scan had missed the clot and the second radiologist had caught it.

    So not only did the first ER doctor get it wrong, but a radiologist missed a life threatening diagnosis.

    Liked by 1 person

    • Carolyn Thomas September 27, 2015 at 11:29 am #

      Wow, you had two misdiagnoses for the price of one, Andrea! I’m wondering if during your first trip to Emerg, you had said something to the ER doc like: “I think I’m having an asthma attack…” If you had, it might have significantly influenced that asthma misdiagnosis and “aggressive” treatment for what was not the problem. I now advise women with troubling cardiac symptoms NOT to self-diagnose once they arrive at the ER (maybe I pulled a muscle, it could be acid reflux, it’s probably nothing, …) as women tend to do while minimizing our symptoms. Once we plant that differential diagnosis in the doctor’s mind, it’s hard to unring that bell – especially if diagnostic tests fail to clearly indicate the actual alternative. In other words, don’t make it easier for them to misdiagnose you…

      Liked by 1 person

  5. Saundra September 27, 2015 at 9:30 am #

    Essentially Carolyn, my and your experience are the same except they didn’t send me home. I spent 2 days in “Observation ” before my cath to confirm LAD blockage before open heart surgery.

    That was 7 months ago and after several phone calls and letters I am finally going to see the Director of Emergency Services of the Level 1 Trauma Center I went to.

    Liked by 1 person

    • Carolyn Thomas September 27, 2015 at 10:36 am #

      Thanks for illustrating the important difference between diagnostic errors: yours was a delayed diagnosis, mine was a misdiagnosis. Both are considered forms of diagnostic error (since both can result in patients being denied timely, appropriate and often lifesaving treatment). It’s so great that you were NOT sent home – keeping you in for observation shows that ER staff did indeed suspect it was likely “something”, but they just needed time to figure out exactly what. Hope you are doing really well now…

      Like

      • Saundra September 27, 2015 at 10:50 am #

        Yes I am and thank you for your persistence in bringing this subject out in the open. I am talking to all of my female friends to check your blog out and to be more aware of their bodies and not to be shy about asking their doctors very important health questions.

        Liked by 1 person

  6. Elvira G. Aletta September 27, 2015 at 7:35 am #

    Dear Carolyn,

    Once again you spotlight a devastatingly important subject that is nothing less than a life and death matter.

    In my own history and that of family members, the frustration of good, well-meaning physicians not listening to the human being before them is too common. They have what my physician brother calls “screen blindness”, meaning they only have time for the lab and imaging results presented on the screen. If the tests come back with no sign of pathology, you must be OK.

    Most recently my beloved older sister, a highly energetic, super-healthy 65 year old, tried for weeks to get her primary care physician (PMD) and his staff to take her symptoms seriously. When the labs came back negative they sent her home. The PMD told her she was getting older so she should expect some slowing down. She protested, but to no avail. Two months later my sister was on dialysis with complete kidney failure.

    My sister and brother-in-law do not want to sue their former PMD. They would be satisfied with a formal acknowledgment that they mishandled her case, an apology and assurance that they will change their practices so that this does not happen to another patient ever again. Neither my sister nor my brother-in-law are holding their breath.

    I don’t think we will ever get to mandatory reporting of mis-diagnoses until we have done something to address the very real fear physicians have of malpractice lawsuits, at least in the U.S. Somehow these two are tied together. I hope something can be done soon to untie the knot before more people are imperiled with severe disability or death.

    Yours sincerely,
    Elvira

    Liked by 2 people

  7. Anna in France September 27, 2015 at 4:58 am #

    Bravo for this Clarion Call, Carolyn!

    I could not agree more.

    As to my heart disease – it was correctly diagnosed & treated (as far as I can tell). However the trainee surgeon (not discussed with me) cut the artery in my arm while inserting the wire during an angiogram & angioplasty was not reported or recorded on my medical record. Not quite the same as misdiagnosis I know, but further evidence of the monumental arrogance and denial practiced by too many doctors.

    I recently received a very bad medical burn during a brief sojourn in Casualty (Emergency) when staff applied two substances on an infection caused by a badly inserted IV line, without cleaning the first off properly before applying the second. Also – not recorded or reported. I arrived in Casualty with a wound the size of a pea and left with one the size of my hand.

    It gets worse (as I am sure you are aware). I have a very dear friend in England who eventually lost both legs as a result of a failure to recognize gangrene after heart bypass surgery. This despite his wife repeatedly telling the visiting nurse and their General Practitioner (doctor) that they believed he had gangrene. This too – unreported. At the time I urged him & his wife to lodge a complaint, but they were too traumatized & exhausted by the sudden end of life as they knew it.

    Until the medical profession stops believing it is above the normal strictures of the rest of us, this deplorable situation will continue.

    I thank you for this brave article.

    Liked by 1 person

    • Carolyn Thomas September 27, 2015 at 5:35 am #

      Thanks so much for your comment, Anna. It seems to me that the issue is not that mistakes happen (we ALL make mistakes, after all), but that there is a culture in medicine in which neither acknowledging (or certainly apologizing for) errors is seen as necessary. Voluntary reporting is simply not working to help protect patients.

      Like

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