How EHR design can affect patient safety

Besides the importance of physician happiness when using an EHR, using design principles that maximize user intuition and presentation of relevant information, there is one aspect of health care information systems that should never be overlooked: patient safety.

Scot Silverstein, MD, blogging at Health Care Renewal as InformaticsMD, frequently brings to light issues surrounding health care IT implementations that compromise patient safety.  Reading his posts should be sobering and concerning to both medical professionals and the public alike.  Like I’ve said, health care IT, in my opinion, is still in its infancy despite the number of years computers have been around and the existence of meaningful use legislation.

As a practicing physician as well as a software coder, I’ve used a number of EHR’s (and still currently using a well known EHR by my employer of my part time job) to know how some of these appalling user interfaces affect not just workflow and user happiness, but patient safety.

An example of one design element that most physicians may not be able to identify, ironically, is the one that is most harmful when it comes to patient safety. In this well known EHR, you are presented a medication list for a patient. As a physician, you assume that this list is a current medication list and is up to date.  However, the reality is that this EHR system automatically removes a medication from the list when it is determined to be expired even if it should be appearing on the current medication list.

When a physician prescribes a medication from this system, it calculates the duration of usage of the medication based on the instructions, quantity of medication prescribed, and the number of refills. Once the duration exceeds the number of days that has elapsed since the prescription was made, the medication is taken off the current list automatically by the EHR. Now, taken at face value, this sounds like the logical approach to manage a medication list and utilizes the computing power that an EHR will gladly show off as a benefit to physicians.

Unfortunately, the EHR programmers failed to understand that medications are not taken regularly by all patients all the time. In fact, no physician assumes that at all. So why should an EHR make that assumption? Furthermore, there are plenty of treatments that are to be taken only as needed so how can an EHR account for that? Absolutely, impossible.

So I recently treated a patient that reportedly has asthma. I happened to look at a previous note and find out that the patient was denied a refill request for albuterol, a bronchodialator that is meant to be taken as needed. She ended up in a life threatening asthma flare up and needed emergent care. It turns out the physician on call who was given the refill request several days prior didn’t realize that the EHR removed the albuterol from her list and subsequently instructed that the patient needed to have a physician visit for having the medication prescribed.

After going through 2 different windows and unclicking a check box, I was able to identify that the patient did in fact have an active prescription for albuterol, but the EHR made it disappear. She has used it infrequently, probably because her asthma was well controlled. Unfortunately, she ended up in worse shape when she needed the medication the most.

Most physicians don’t have the time nor the technical know-how to peer through a complicated EHR. Perhaps I normally don’t trust the EHR because I’ve be jaded by bad designs and because I know how to hack around a system when a bad design didn’t give me the information that I want.

But this example highly illustrates that a poorly designed EHR that has not gone through a reality test with a practicing physician leaves patient safety in harms way. I ultimately find it appalling that physicians are being peddled multi-million dollar systems that have not had any real practicing physician input in how these systems are designed.

We are beginning to see studies that question the effectiveness of EHRs when it comes to health care cost reduction and patient safety. One should not make a general conclusion that all EHR’s don’t help, are a waste of money, and have no place in health care. What gets lost in the translation is that an electronic health record system is not the same from one system to an another. Some do a better job than others. What doesn’t get studied is how physician directed user design can affect these results.

From other industries where user design is absolutely paramount, including automobile and airplane ergonomics as well as smartphone operating systems and their apps, we know how improved and user informed design makes all the difference in terms of quality output by the user. It’s all about using the right tools for the job. If it can be used intuitively, reliably, and repetitively, you have the right tool for the job. Right now, most EHR’s are like sledgehammers when what we really need are sharp chisels that create works of art.

Michael Chen is a family physician who blogs at NOSH ChartingSystem.

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  • http://onhealthtech.blogspot.com Margalit Gur-Arie

    Dr. Chen, I am not defending this EMR, since I don’t know which one it is, but the entire issue of removing meds from the active med list automatically is done precisely because of physicians input.
    The arguments go something like this: the med list is cluttered with all these antibiotics and such, which are obviously prescribed for just a few days, and I can’t see the “real” meds because of this clutter. Well, you can always click on the “deactivate” or discontinue box and move it off the list. How am I supposed to remember to go into every chart and deactivate all my prescriptions? This is a computer isn’t it? OK, how about we give you a place to enter a Stop date, and then things will drop off the active list after that date? Why should I have to type in one more thing? Can’t the damn computer do simple math that a 5 year old can do? OK, I guess it can, but how about PRN? I don’t do a lot of that (pediatrician), I’ll move it back to the active list if I need to… just give me a way to toggle back and forth….just give me a way to see everything in one page and gray out the inactive ones….takes me two extra minutes to sort through all the grayed out stuff…get rid of it… why don’t we make it a preference and let them choose how they want this to work for them….
    Of course in a large system, doctors choose little to nothing, but I’m willing to bet that there is a configuration item somewhere in the admin section.

    • Michael Chen, MD

      Margalit,
      The scenario you outlined is precisely the reason why EHR’s should not be designed to “outsmart” the physician. I get that we don’t want a cluttered medication list, but if one thinks about the traditional physician’s clinical workflow prior to the advent of EHR’s, the medication list is only as current as the most previous encounter (telephone, visit, hospital admission, etc), not what the medication list ought to be in “real time”. Because who knows what is the medication list is real time (hence my argument that doctors do not assume that the medication list is completely accurate). But it would be more damaging to assume by the physician that the medication list is accurate when in fact, a computer has wiped the medication list clean of what it thinks it ought to be based on a date calculation. This is analogous to a financial workflow system where an accountant has to reconcile their financial accounts to a bank statement. I have never seen an accounting software program just automatically reconcile the entry without human intervention. Yes, it is tedious, but when a physician has to know from a patient what medications they are taking at that time (and most patients don’t bring a medication bag or list with them, so it helps to have the previous record, not a “cleaned up” record), it is much safer to NOT let a computer do this without human intervention even when there is a stop date entered. My patients appreciate it when I do review their medication list and it looks rather strange when you have re-enter a medication they know they are taking chronically all because a stop date has caused the medication to electronically disappear.

      On a side note, I had spoken with another physician who used to work at Kaiser (and for those who know what EHR they use, this is what I’m referring to in my post) where they have to jot down on paper a medication list from the patient because they cannot trust what the EHR is telling them. And then this gets re-entered on the EHR later on. Furthermore, it was not just one physician, it was instituted hospital-wide for that particular hospital (I don’t know if it was Kaiser-wide). I would argue that is more of a waste of resources and technology (not to mention money) to do a old-tech workaround for a poorly designed interface.

      • LeoHolmMD

        Good point. Why are there “work arounds” to begin with? Would any other device that you “cannot trust” be located in a hospital or clinic?

        • ssilverstein

          I have long ago written a rule:

          “You do not need to work around something that is not in your way.”

      • http://onhealthtech.blogspot.com Margalit Gur-Arie

        Dr. Chen,
        I was quoting (from memory) conversations with actual practicing physicians, who wanted the EMR to do these things for them, and be smart about how it does them. This is not about outsmarting anybody. It’s about responding to customer requests, which are always conflicting, and that’s how general market EMRs end up with hundreds of setup and configuration items, because nobody dares tell a physician customer, sorry but you will have to manually discontinue the meds you want to discontinue and the computer will not be helping you here. Just like (almost) nobody dares say that you should click on every “normal” box if you want a “big” note, instead of getting all the normals with one click (to save time).
        I don’t know about the Kaiser EMR, but nothing is wiped clean. All meds ever prescribed or entered are still there, active or inactive. There is usually an “active” med list and a “historical” list, which should be immediately accessible from the active list.

    • ssilverstein

      That is simply absurd and an insult to physicians, who would never concur with the automated discontinuation as Dr. Chen described.

      if you had opined that it was some programmer’s idea of what they thought physicians wanted, and then was not vetted properly, that I could accept.

      • http://onhealthtech.blogspot.com Margalit Gur-Arie

        I am sorry to have to disagree, but as absurd as this may sound to you, some folks want stop dates to be calculated and acted upon automatically, particularly for short term prescriptions such as antibiotics.
        I actually don’t think this is a bad idea if implemented correctly (i.e. if you could select specific med-diagnosis pairs for which to activate the auto stop, and perhaps other parameters as well – basically a more intelligent way than just a sledgehammer across the board).

        • ssilverstein

          Yes, it does sound absurd. References please.

          • http://onhealthtech.blogspot.com Margalit Gur-Arie

            I did not have the presence of mind to record my conversations back then, and since they were in person, I don’t think the NSA has a record either, so let’s just leave it at that. Thanks.

  • southerndoc1

    Try entering a few standardized orders in your laptop EMR while driving down the Interstate at 70 mph. If you find that dangerous, just realize that it’s equally dangerous to sit doing data entry and MU chores in front of a patient who has come to you for medical care.

  • Michael Chen, MD

    Scot Silverstein, MD has a lot to say in his blog about the culpability (legal or otherwise) of unsafe EHR’s, I won’t try to re-hash here. The point that he makes is that EHR’s should be treated like medical devices and governed by the FDA just as pharmaceuticals and surgical implants are at risk for litigation due to patient harm. Obviously, that is not the case currently.

    I’m not so sure that the large EHR companies will really listen to MD input any time soon. Even nurses have put up a fuss about the safety of EHR’s to their administrators and legislators without much headway (see Dr. Silverstein’s site for examples). And unfortunately, many patients do not equate the doctor’s EHR’s as medical treatment devices (and I personally do not think EHRs should be designed or have features to provide or dictate medical treatment) so they don’t really target EHR’s as the cause of negative medical outcomes. Can and should MD’s sue EHR companies instead for bad designs? That would be interesting…

    • Deceased MD

      A lawsuit is finally here. Read it in Modern HC.
      A Montana hospital is suing their EMR company who failed to keep up with stricter requirements. Go figure how they managed that given what you said about EHR’s not being able to sue.
      Also just to add what is out of control is Feds cracking down on “cut and paste EHR fraud”. ( another Modern HC article)
      This is for another article about EMR but this aspect of over regulation is so out of control. Is this a surprise that cut and paste is used?

      • Michael Chen, MD

        Thanks for the update; I figured it was only a matter of time…it remains to be seen how effective this is in turning back the tide and improving EHR usability and safety. I’m a pessimist when it comes to bueracracy…I’d say not likely in my lifetime.

        • Deceased MD

          LOL. I am a pessimist as well so completely understand. I was kind of appalled at the cut and paste fraud as well. No doubt it will be in courts for a long time and make attorneys rich but as you say not improve our lives in the least.

    • ssilverstein

      See this nurses’ complaint story, it’s stunning:

      Affinity Medical Center (Ohio) Nurses Warn That Serious Patient Complications “Only a Matter of Time” in Open Letter

      http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html

      I am just the reporter here, but a union official did tell me one of the reasons the nurses could be so vocal is that the union partially protects them from retaliation.

      A judge had to intervene when a supervisor threatened to paste EHR safety complaints to nurses’ foreheads, however: http://hcrenewal.blogspot.com/2013/07/hows-this-for-patient-rights-affinity.html > I wish I were making that up.

      At another medical center, clinicians are apparently obligated to sing EHR praises: http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html

      I wish I made that up, too.

  • LeoHolmMD

    Many EHR companies already thought of that, and have a hold harmless clause in the contract. The idea (or fact if you will) that EHRs are unapproved medical devices that have not been tested for safety or efficacy has not gained much momentum unfortunately.

    • Deceased MD

      Thanks for the explanation. That figures. There are always ways around this with good lawyers but i’m afraid they have become way to powerful. Something you probably figured out a long time ago. i am just beginning to see the whole pic here.

  • Deceased MD

    Thank you for explaining that Dr. Chen. You are way ahead of me on that. But all I know is something has got to give here.

    I will take a look at Scot’s blog. thanks.

    • http://onhealthtech.blogspot.com Margalit Gur-Arie

      I think the problem is slightly different. Computers are really good at repetitive standardized tasks. Your profession is anything but. There is a very poor match between what computers excel at and what doctors do. Trying to bridge this gap, by stuffing the practice of medicine into the computer paradigm is doomed to fail, unless we change what medicine is all about or wait patiently until computers get better at non-standard workflows.
      Unfortunately, we chose the former. Sometimes, what the EMR does, happens to fit this or that doctor, or this or that patient, and then you have the cheerleaders saying that everybody else is a Luddite. Other times the EMR way is so at odds with what a doctor does that he or she really sounds like a Luddite. Most folks fall somewhere on the wide spectrum in between.
      In my humble opinion, we should dial back on both expectations and computations, and have the EMR do simple things that have little to do with actual medicine (e.g. filing, searching, retrieving, counting, scheduling, messaging, etc.) and get out of the business of dictating the content and structure of the patient/doctor interaction. There is nothing wrong with “unstructured” data. It’s how humans think and how they communicate, and the machine is not yet good enough to supplant that.
      This of course ignores the fact that EMRs always came with a secondary mission (first billing and now surveillance), which isn’t really secondary at all. Medical care is the one thing that is secondary (maybe even tertiary) to what most commercial EMRs are forced to do.

      • southerndoc1

        Great, great comment, really the best articulation I’ve read of what many of us feel instinctively.

        • http://onhealthtech.blogspot.com Margalit Gur-Arie

          Thank you, southerndoc.

      • ssilverstein

        “Other times the EMR way is so at odds with what a doctor does that he or she really sounds like a Luddite. ”

        All, see this essay about physicians being “Luddites” –

        “Doctors and EHRs: Reframing the ‘Modernists v. Luddites’ Canard to The Accurate ‘Ardent Technophiles vs. Pragmatists’ Reality” –

        http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html

        “wait patiently until computers get better at non-standard
        workflows”

        That will happen when a very hot subterranean place ruled over by a large red creature with a pointy tail experiences weather like we just had the past few days.

    • Michael Chen, MD

      Thanks for the compliment, but I would have to say that I truly believe that most doctors have a generally good idea about how they would like an EHR to function…it’s just not in the framework of how EHR’s function currently. And that every situation is different so EHR functionality is going to be different from one environment to the next. And that is OK. They just need to talk to each other (which they do not), and that’s the important part. I don’t even think that what I have developed as an open source EHR is even close to what I envision would be the ideal way an EHR is supposed to function to optimize patient care. I think it’s better than most, but not ideal and still too structured for my own tastes (I’m a fan of unstructured data). But I think it is a vehicle to get us there, to bring a community of users to continue to refine, improve, and push the technological limits to where we want to go without sacrificing patient care and not get enslaved by what a corporatized framework is dictating to us through Meaningful Use and other means that leave doctors very little choice in their practice. What I envision, like Margalit hinted at is the idea that we do not need to have structured data to still make EHR’s useful once the data entering is done. There are technologies (in the pipeline) that aim to do that all behind the scenes and doesn’t scream at physicians to conform to these standards of data entry. But doctors can either continue to stay on the sidelines or take the reins and make it happen to their advantage and benefit for safe and better patient care.

    • ssilverstein

      Re: bad software engineering.

      See this analysis of a major US ED EHR the Australians in NSW were going to inflict on their physicians: “A study of an enterprise health information system” – http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146

      The summary is quite interesting.

  • Deceased MD

    An EMR company is being sued by a montana hospital, according to Modern HC article. Apparently, the Montana hospital may be among the first of many providers to go to court to resolve their frustrations with electronic health record systems developers that are either lagging or failing to update their software to the new, more stringent testing and certification requirements.

  • http://onhealthtech.blogspot.com Margalit Gur-Arie

    It would be wonderful, but not very likely to happen, because the money will not take care of itself. Not in this environment, where EMRs are now government/payer policy levers, and the number of doctors refusing to be manipulated by this electronic lever is shrinking every day. This is a decision that goes way beyond technology….

    • Michael Chen, MD

      I agree that the forces that be are shaping the future of our system, but I wonder about some of the doctors that are going outside of these government/payer policy levers (ie direct pay practices, independent practices, practices that do not see Medicare/Medicaid). Where are they going? This population is where I see the most response to my open source EHR, as well as those docs contemplating getting off the bandwagon.

      • http://onhealthtech.blogspot.com Margalit Gur-Arie

        Do you see significant uptake, Dr. Chen?

  • Deceased MD

    I stand corrected. LOL. Thanks.

  • ssilverstein

    I am just the reporter here -

    Note the ECRI Institute 2012 Deep Dive study of EHR safety. ECRI Institute (google it) did a 9 week voluntary study of 36 PSO member hospitals, that reported 171 health IT “events” serious enough to cause harm. 8 of those incidents did involve harm, and 3 possibly contributed to patient deaths.

    Also note that voluntary studies produce a small fraction of the real number of events, especially when the event could be a cause for litigation ..

    This study suggests massive systemic problems.

    See http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html for more stats.

  • ssilverstein

    Allow me to point out that direct clinician data entry of detailed data WAS AN EXPERIMENT. It had no historical precedent. Only now are this experiment’s failures coming to light…abuses e.g., involving upcoding and overcharging; HHS OIG report just came out yesterday – and clinician time overload and care quality/safety compromise come to mind. The EHR hyperenthusiasts would be prudent to consider what to do if the clinician data entry experiment proves an insurmountable failure. I believe that no matter how clever the interface, direct clinician data entry may prove an insoluble problem the way medicine and its bureaucratic oversight exist today.

    See more on this theme at “Doctors’ Dissatisfaction With EHRs May Be Early Warning of Deeper Quality Problems – And Some Common Sense on EHRs and Clinician Distraction and Time-Wasting” – http://hcrenewal.blogspot.com/2014/01/doctors-dissatisfaction-with-ehrs-may.html

  • ssilverstein

    See NYT article and linked HHS OIG report on the overbilling/fraud issue – released yesterday –

    NYT article “Report Finds More Flaws in Digitizing Patient Files” at http://www.nytimes.com/2014/01/08/business/report-finds-more-flaws-in-digitizing-patient-files.html

    HHS OIG report at: http://oig.hhs.gov/oei/reports/oei-01-11-00571.pdf

    • LeoHolmMD

      The real fraud: EHRs will improve patient care, save money, blah, blah, blah…

  • ssilverstein

    Considering that health IT is the only healthcare sector not subject to meaningful regulation, the EHR sellers can sell whatever they can get a purchaser to buy. The MU criteria and evaluation process is a start, and a very weak one at that. It certainly does not involve the kind of testing done of software in other mission critical sectors, such as aerospace or energy.

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