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posted by chromas on Wednesday March 27 2019, @10:22PM   Printer-friendly
from the frmForm1 dept.

Submitted via IRC for Bytram

Death by a Thousand Clicks: Where Electronic Health Records Went Wrong

The pain radiated from the top of Annette Monachelli’s head, and it got worse when she changed positions. It didn’t feel like her usual migraine. The 47-year-old Vermont attorney turned innkeeper visited her local doctor at the Stowe Family Practice twice about the problem in late November 2012, but got little relief.

Two months later, Monachelli was dead of a brain aneurysm, a condition that, despite the symptoms and the appointments, had never been tested for or diagnosed until she turned up in the emergency room days before her death.

Monachelli’s husband sued Stowe, the federally qualified health center the physician worked for. Owen Foster, a newly hired assistant U.S. attorney with the District of Vermont, was assigned to defend the government. Though it looked to be a standard medical malpractice case, Foster was on the cusp of discovering something much bigger—what his boss, U.S. Attorney Christina Nolan, calls the “frontier of health care fraud”—and prosecuting a first-of-its-kind case that landed the largest-ever financial recovery in Vermont’s history.

Foster began with Monachelli’s medical records, which offered a puzzle. Her doctor had considered the possibility of an aneurysm and, to rule it out, had ordered a head scan through the clinic’s software system, the government alleged in court filings. The test, in theory, would have caught the bleeding in Monachelli’s brain. But the order never made it to the lab; it had never been transmitted.

The software in question was an electronic health records system, or EHR, made by eClinicalWorks (eCW), one of the leading sellers of record-keeping software for physicians in America, currently used by 850,000 health professionals in the U.S. It didn’t take long for Foster to assemble a dossier of troubling reports—Better Business Bureau complaints, issues flagged on an eCW user board, and legal cases filed around the country—suggesting the company’s technology didn’t work quite like it said it did.

Until this point, Foster, like most Americans, knew next to nothing about electronic medical records, but he was quickly amassing clues that eCW’s software had major problems—some of which put patients, like Annette Monachelli, at risk.

Damning evidence came from a whistleblower claim filed in 2011 against the company. Brendan Delaney, a British cop turned EHR expert, was hired in 2010 by New York City to work on the eCW implementation at Rikers Island, a jail complex that then had more than 100,000 inmates. But soon after he was hired, Delaney noticed scores of troubling problems with the system, which became the basis for his lawsuit. The patient medication lists weren’t reliable; prescribed drugs would not show up, while discontinued drugs would appear as current, according to the complaint. The EHR would sometimes display one patient’s medication profile accompanied by the physician’s note for a different patient, making it easy to misdiagnose or prescribe a drug to the wrong individual. Prescriptions, some 30,000 of them in 2010, lacked proper start and stop dates, introducing the opportunity for under- or overmedication. The eCW system did not reliably track lab results, concluded Delaney, who tallied 1,884 tests for which they had never gotten outcomes.

The District of Vermont launched an official federal investigation in 2015.

eCW’s spaghetti code was so buggy that when one glitch got fixed, another would develop, the government found. The user interface offered a few ways to order a lab test or diagnostic image, for example, but not all of them seemed to function. The software would detect and warn users of dangerous drug interactions, but unbeknownst to physicians, the alerts stopped if the drug order was customized. “It would be like if I was driving with the radio on and the windshield wipers going and when I hit the turn signal, the brakes suddenly didn’t work,” says Foster.

The eCW system also failed to use the standard drug codes, and in some instances, lab and diagnosis codes as well, the government alleged.

The case never got to a jury. In May 2017, eCW paid a $155 million settlement to the government over alleged “false claims” and kickbacks—one physician made tens of thousands of dollars—to clients who promoted its product. Despite the record settlement, the company denied wrongdoing; eCW did not respond to numerous requests for comment.

If there is a kicker to this tale, it is this: The U.S. government bankrolled the adoption of this software—and continues to pay for it. Or we should say: You do.

Which brings us to the strange, sad, and aggravating story that unfolds below. It is not about one lawsuit or a piece of sloppy technology. Rather, it’s about a trouble-prone industry that intersects, in the most personal way, with every one of our lives. It’s about a $3.7-trillion-dollar health care system idling at the crossroads of progress. And it’s about a slew of unintended consequences—the surprising casualties of a big idea whose time had seemingly come.

[Click through to read a whole lot more.]


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  • (Score: 2) by JoeMerchant on Thursday March 28 2019, @02:20AM (9 children)

    by JoeMerchant (3937) on Thursday March 28 2019, @02:20AM (#821115)

    Let's not forget the HILs (Humans In the Loop).

    The doc could have / should have communicated the need for the test clearly to the patient.

    The patient then could have / should have followed up to ensure they got the test they need from the obviously indifferent system that provides the testing.

    The indifferent system that provides the testing could have / should have had sufficient capacity to see this patient within a few days so she can get the testing that would could have / should have saved her life: stents can work miracles, but only if you know you need them.

    Too much of the healthcare system in the USA is on its heels, reacting to emergency life-threatening situations, triaging those with the most immediate need ahead so: if you're not absolutely dying this minute, your typical experience is to wait hours in the ER, days for tests. We should have the capacity to serve the preventative and less-than-dying care market, but for the most part the system encourages them to stay the hell away from health care providers, even if they are insured: copays are ridiculously high, scheduling makes the patient's life and work the last priority, and providers often order up all the most handsomely reimbursed tests just to maximize the positive fiscal benefit from every sucker, ahem patient, who does venture into the office - prescribes the most profitable drugs just incase they might do more good than harm, and the graft goes as far as lap dances for prescriptions written [washingtonpost.com].

    We all die in the end, and I'm starting to think that subjecting myself to the medical-industrial-complex does more net harm than good for my quality of life.

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  • (Score: 3, Interesting) by MostCynical on Thursday March 28 2019, @02:31AM

    by MostCynical (2589) on Thursday March 28 2019, @02:31AM (#821121) Journal

    ...starting to think that subjecting myself to the medical-industrial-complex in the US does more net harm than good for my quality of life.

    FTFY
    Not all countries commodify and commercialize health care the same way.

    --
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  • (Score: 2) by All Your Lawn Are Belong To Us on Thursday March 28 2019, @04:32AM (7 children)

    by All Your Lawn Are Belong To Us (6553) on Thursday March 28 2019, @04:32AM (#821169) Journal

    Too much of the healthcare system in the USA is on its heels, reacting to emergency life-threatening situations, triaging those with the most immediate need ahead so: if you're not absolutely dying this minute, your typical experience is to wait hours in the ER, days for tests.

    If one is not absolutely dying this minute then the ER is not necessarily the location one should be in, as Prompt Care/Urgent Care would likely be much more appropriate. The ER staff will still see you, because if you show to ER they must assess you and provide appropriate treatment, appropriate meaning if you are not emergent then then you get passed to the part of the diagnostic healthcare system not burning money in the thousands of dollars per hour.

    Sometimes I wonder if that system is really best. But the priority at ERs are exactly those who are (or may have) a condition of either dying or imminent correction is necessary to avoid death. If that doesn't fit you, expect a wait because you're not engaging the system appropriately.

    The other important thing to understand is that the client/patient is expected to take an active role in their own understanding of health. You are your own best advocate and the complex expects you to be such. There are safety valves in the system: nurses are supposed to be one where patient advocacy is a charged role. But only you can define what you feel your quality of life needs to be, not the system. Once you define that and communicate it, the medical system will move to help you realize as close to it as is possible.

    Just thoughts....

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    • (Score: 2) by PiMuNu on Thursday March 28 2019, @10:09AM (2 children)

      by PiMuNu (3823) on Thursday March 28 2019, @10:09AM (#821241)

      > only you can define what you feel your quality of life needs to be

      The nature of the problem means that this is often not appropriate. Most health care is dealing with people who are mentally or physically incapacitated (I am thinking of elderly among others).

      • (Score: 2) by All Your Lawn Are Belong To Us on Thursday March 28 2019, @11:28AM (1 child)

        by All Your Lawn Are Belong To Us (6553) on Thursday March 28 2019, @11:28AM (#821257) Journal

        Those who are physically and mentally incapacitated are still capable of defining what is and is not acceptable QOL and can take an active role in their own treatment more often than not. Elderly is not a synonym for incapable. For dementia-spectrum individuals one can still gauge whether they appear comfortable. It is not always possible to achieve a cure but improvement can still be found based on their reactions. The challenge is much more allocating the resources where such is possible. And in any event we were still in the context of Emergency Room care here, which is geared towards the immediate saving of life. Though it is true that care facilities often deal with challenge issues with patients like these by calling 911 instead of arranging appropriate care. So good point nevertheless!

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        • (Score: 3, Interesting) by PiMuNu on Thursday March 28 2019, @02:10PM

          by PiMuNu (3823) on Thursday March 28 2019, @02:10PM (#821320)

          I was reacting also to a comment up the thread that suggested that the patient should be checking that they have received all of the appropriate tests and complaining if they have not.

    • (Score: 1) by pTamok on Thursday March 28 2019, @11:49AM (1 child)

      by pTamok (3042) on Thursday March 28 2019, @11:49AM (#821261)

      The other important thing to understand is that the client/patient is expected to take an active role in their own understanding of health.

      Patients don't have the advantages of a medical education. Doctors, as trained professionals, have a duty of care - and while it is nice to have actively engaged patients with a good understanding of their health status, that is a rare occurrence. Many, if not most patients expect their doctor (or other health care professional) to tell them what to do.

      Health care professionals need to do their damned jobs. Blaming the victim (patient) for their own (the doctor's) incompetence or disengagement is all too frequent. Doctors are lucky that most patients don't question their healthcare, because there are frightening levels of medical mistakes and lack of follow ups. I will add that being an engaged patient doesn't guarantee good results. There are countless stories of patients (who might be expected to have the best insight into their own condition) being ignored, sometimes for years. I know one young lady who had spent most of a decade trying to get treatment for a sleep disorder - even to the extent of her own doctor ignoring the explicit instructions of the specialist she finally got to see. As a single anecdote, it is meaningless, but it concurs with my own families experiences across several doctors that, once the doctor has made up their mind regarding their diagnosis, it is almost impossible to get it changed. I'm not sure if there are academic studies into this phenomenon, but delay of correct treatment following identification of a incorrect diagnosis seems to be a real problem - ahh here we go:U.S. Department of Health and Human Services: Agency for Healthcare Research and Quality: Patient Safety Network: Diagnostic Errors [ahrq.gov]

      In the Harvard Medical Practice Study, diagnostic error accounted for 17% of preventable errors in hospitalized patients, and a systematic review of autopsy studies covering four decades found that approximately 9% of patients experienced a major diagnostic error that went undetected while the patient was alive. Taken together, these studies imply that thousands of hospitalized patients die every year due to diagnostic errors.

      The medical profession could learn from the aviation industry and introduce a 'just culture', so that doctors and others participating in the delivery of medical care are not vilified for their mistakes, but instead encouraged to report them (anonymously) so that the system as a whole can be improved to reduce their incidence. It is not about blame, but improving outcomes for patients. Doctors are human, and humans make mistakes. What we need are systems that make mistakes less likely, minimise the consequences of mistakes, and reduce their future likelihood. Such a system should, in fact, make healthcare providers jobs easier in the long run - and provide better care for the ill.

      • (Score: 2) by All Your Lawn Are Belong To Us on Thursday March 28 2019, @06:55PM

        by All Your Lawn Are Belong To Us (6553) on Thursday March 28 2019, @06:55PM (#821449) Journal

        Nevertheless, a patient is generally expected to be responsible for themselves, first and foremost. A patient is expected to educate themselves or be open to being educated to make rational decisions. And patients who do make irrational healthcare decisions or refuse to take reasonable care of themselves inure the providers from liability. If there are conditions whereby a patient cannot be responsible for themselves then there are changed standards of care to ensure that conditions and treatment decisions are made by someone else who does know. This is a change from, "Doctor will do this, and you have no say whether Doctor will do this, because Doctor has accepted responsibility not just for treatment of your condition but responsibility of your care," such problems having been determined in the past to be worse than what we have today.

        What is the job of a physician? (And, with variation, other licensed healthcare providers have variations on the below).

        Doctors do have duties to respect the standards of care. But that just brings up: What does "standard of care" mean? Wikipedia summarizes it well enough, "A standard of care is a medical or psychological treatment guideline, and can be general or specific. It specifies appropriate treatment based on scientific evidence and collaboration between medical and/or psychological professionals involved in the treatment of a given condition."

        What this is not:
            Doctors cure patients.
            Doctors make sure patients are cured.
            Doctors make sure patients comply.
            Doctors make sure their diagnoses are perfect and without a doubt what the patient condition is.

        What it is:
            Doctors make sure patients are adequately informed of their conditions as best can be determined. (And such determinations are generally acceptable to the provider community as a whole).
            Doctors make sure patients understand what is being done and why.
            Doctors make sure the patient has consented to what they are doing to the patient and why.
            Doctors make sure the patient understands the risks, benefits, complications or potential complications, and the risks of not proceeding with the recommended treatment.
            Doctors have followed medically recognized guidelines for the practice of their care.
            Doctors guidelines are tested scientifically and are both effective and efficient (maximizing resources of time and money for the greatest good to the greatest number of people).

        Their damned job is to be professionally competent to recognize and treat disease patterns as other professionals in the class do. Does that means misdiagnoses happen? Yep, a lot! Is a misdiagnosis fatal? Possibly, not necessarily. How much harm does a particular misdiagnosis result in a life lost in a way that some other doctor would have found? Did the missed diagnosis cause death, and was that diagnosis something missed? That's why we have malpractice - to ensure your provider, as best as possible, knows and follows the standards of care. (And that's way beyond that Mr. and Mrs. America think the Doctor 'shoulda done better.')

        Can improvements happen? Absolutely. That's why IOM/NAM and QSEN and many other organizations exist to try and raise both outcomes and overall quality. But it doesn't start with, "Doctor decides to do X to patient and therefore just does it."

        The medical practitioner industry would love to move towards a just culture. (Just in medication errors alone would be nice, and there are hospitals that do embrace that particular case). The malpractice industry will not let that occur IMVVHO. Nor will Mr. and Mrs. America who thinks their medical error should be worth millions, or Mr. and Ms. Lawyer who run ads late at night telling you that your having been victimized by ________________________ could mean you're entitled to cash - just call!!!

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    • (Score: 2) by JoeMerchant on Thursday March 28 2019, @04:37PM (1 child)

      by JoeMerchant (3937) on Thursday March 28 2019, @04:37PM (#821394)

      If one is not absolutely dying this minute then the ER is not necessarily the location one should be in

      Case(s) in point: last two family visits to the E.R. - one was for suspected blood poisioning infection (could lead to loss of limb if not treated promptly), first noticed at 4:30pm on a Sunday, the E.R. was the only treatment facility available within 100 miles that was open before the following morning. Wait time: until 11:30pm

      Cut foot @ 10pm, approximately 10oz of blood lost, 8 stitches required. Again, E.R. was the only option before morning. Checked in @ 10:10pm, stitches applied to wound @ 5:30am.

      As to less pressing medical needs: most of the uninsured can't afford other care, so they go untreated until their needs are appropriately
      addressed in the E.R. - which is almost never the most cost effective or highest quality of life course of action.

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      • (Score: 2) by All Your Lawn Are Belong To Us on Thursday March 28 2019, @06:25PM

        by All Your Lawn Are Belong To Us (6553) on Thursday March 28 2019, @06:25PM (#821435) Journal

        I agree with you that prompt care facilities should be held to something similar to EMTALA - show up and you must be treated - and you have a point. IANAL nor an expert in that area, only read this [youtube.com] just now where hospital-connected urgent cares may also have EMTALA liability. (For any not in the know Emergency Medical Treatment and Labor Act of 1986 is the law that says an ER must stabilize a patient regardless of anything else. The "don't let a patient die on the hospital steps" law.)

        10 ounces of blood loss in an adult (most importantly Bleed Controlled) is something that can wait to be stitched. Fun? Hell, no. But, uncomplicated, not a life threatening emergency though it is on the borderline of hypovolemic symptoms depending on total patient blood volume. Treatable in ER? Yep! Of course it will be stitched (or stapled or glued but stitches are probably best in a foot). Life-threatening emergency? Not if the bleed is controlled. If the bleed is uncontrolled then watch how the system swings into action to make lifesaving care happen - and there may be a delay between bleed control and stitching even then. (In fact, a doc might want to push a little bit of fluids to re-perfuse the tissues if that can be done without reopening the bleed before stitching either way. Stabilize before closure. Dunno.)

        Blood poisoning infection: IS an emergency of ER grade quality. Will the patient die in 7 hours? Well, if the patient was sweaty and shocky you'd see a sepsis code and watch how the system swings into action to make lifesaving care happen. Again: The point of an ER is to stabilize the patient, not cure the infection.

        And in both the cases above the staff should be keeping an eye on the patients in sufficient frequency to recognize a downswing and be ready to treat accordingly. But the key is: Stable patients can wait. Unstable patients can't. And they don't stick themselves in situations where the care of stable patients means an unstable one doesn't get immediate treatment.

        Another thing most people don't realize: ER must diagnose and stabilize. Actual treatment of a non-emergent condition beyond stabilization is legally regarded as billing fraud. Unnecessary care in the emergency room setting is an unnecessary service and therefore not paid, I kid you not. Is that insane? In its way, yes. But ER's do not want to be the dumping ground for nonemergent conditions since other care modes are available. Especially when that care would be free because insurances would reject - see Billing Fraud, again.

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