By MARGALIT GUR-ARIE
Back in the times when EHRs were just EMRs, they had a very simple and humble mission. The software was supposed to help providers of health care services better manage their business. EMRs were supposed to help physicians adhere to CMS documentation rules, automate patient flow management and get rid of all the mountains of paper floating around a typical medical office or hospital. It was assumed that EMR software will increase reimbursement rates, streamline workflow and even make the doctor more efficient. After all, every other industry that switched to computerized business management realized bottom line improvements.
Along the way, bolder statements started appearing, mainly from EMR vendors trying to sell their wares. EMRs could also reduce medical errors. The most common argument was for the benefits of replacing the notoriously illegible physician hand writing. Prescription errors would be reduced if only pharmacists and nurses could get a nice legible script. Then came the frequently misplaced paper charts. If the chart resides in the computer, it cannot be misplaced, it is always available to all and it is complete. All the information you need right at your fingertips, regardless of your physical location. It could save lives or at the very least, it could save time. The EMR was nothing more than an electronic chart. One vendor went so far as to create a computerized image of a yellow manila folder with tabbed pockets for various items in the electronic chart.
Nobody thought the electronic chart needed to be regulated by the FDA any more than the paper chart was. After all, the EMR was not providing medical care; it was just a more effective place to record administered care. Or was it? There is a funny thing about computers. They have a mind of their own, a mind created by programmers, a mind which makes them interactive. A paper chart is passive. If you want to see all lab results in a paper chart, you have to decide where to look and actively flip the pages. If you missed one page, it’s your omission, not the chart’s mistake. If you want to see all lab results in an EMR, you click a button and the software does all the paging returning a convenient list for you to look at. If the software missed a page, it’s the software’s fault, not yours. The software is controlling what you see and how you see it. This small fact renders the electronic chart a full partner in delivering health care; it is now a medical instrument.
And then the EMR grew up and became an EHR. The EHR performs tasks for you, like calculating dosage for medications or just simple BMI. The more advanced EHRs presume to give you advice on what to order for a certain condition, or what not to order based on what it knows about your patient. There are EHRs now, and there will be more in the future, which communicate with other software and automatically, bring in medical data and place it in the chart. This sophisticated software makes decisions regarding patient identities and about schedules for preventive care and disease management. Computers are not infallible. Their mistakes are called “bugs” or “software glitches” and just like the nurse or the medical records clerk sometimes placed the wrong piece of paper in the chart, EHRs can, and do, corrupt medical records. Incorrect, incomplete and indecipherable medical records can lead to injury and even death. But does it really happen?
Do EHRs actually kill people?
The Huffington Post has been investigating this exact question. Between January 2008 and February 2010, the Huffington Post identified 237 reports in the voluntary incident reporting FDA database related to HIT, including 6 deaths and 43 injuries. However, a closer looks reveals that only a small fraction of these reports are actually related to EHRs per se. Most reports involve PACS, medication dispensing systems, blood banks and other FDA regulated equipment. Out of the 6 reported deaths (2 of which occurred in 2006), one was related to a PACS system latency, another to human error in labeling an x-ray cassette and another to a hospital pharmacy system. 2 deaths were attributed to system wide failures of CPOE and one to lack of intuitiveness in display of notes. As to injuries, out of the 43 reported, I could only count 17 directly related to EHR software and most have to do with CPOE.
Is this the tip of the iceberg, as some contend? Are there many more unreported deaths caused by EHR software? There may be, but frankly, the evidence of massive numbers of adverse events is not there. It does, however, stand to reason that voluntary reporting would be incomplete and the fact that only a couple of EHR vendors are represented in the FDA database is suspicious to say the least. On the Health Care Renewal blog they are engaging in what I think they know are rather creative mathematics, to project hundreds of thousands of injuries per year if, and when, EHR adoption really takes off.
If EHRs become as pervasive in everyday medicine as ONC is proposing, every patient will eventually be touched by an EHR. It is very likely, that some errors will be prevented by the sheer existence of an EHR, but new and unfamiliar errors will also be introduced as side effects. Of course, the potential benefits must be shown to significantly outweigh the hazards, and we already have accepted mechanisms for such assessments.
While ONC is exploring collaboration with the FDA, and the FDA seems willing to engage, the customary counterargument is that FDA processes will stifle innovation and make EHRs unaffordable. There is validity to such arguments, but as long as money seems to be no object for HITECH, maybe we can spend some of it on devising reasonable and affordable methods of testing patient safety, both pre- and post-market. Innovation will take care of itself and the alternative is unconscionable.
Margalit Gur-Arie blogs frequently at her website, On Healthcare Technology. She was COO at GenesysMD (Purkinje), an HIT company focusing on web based EHR/PMS and billing services for physicians. Prior to GenesysMD, Margalit was Director of Product Management at Essence/Purkinje and HIT Consultant for SSM Healthcare, a large non-profit hospital organization.
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I teach, install, and program EHR and I am more concerned about providers who document that they did a procedure, such as a rectal exam when it fact it was not done. Like the old axiom, “to err is human, to really mess up requires a computer”……I just don’t see it. The benefits far far far outnumber the problems.
You may be interested in this related post on eMRs and FDA regulation
http://medicalexecutivepost.com/2010/03/01/the-fda-and-emr-regulation/
Dave Marcinko
http://www.MedicalExecutivePost.com
Great post. Glitches and bugs in software will always exist. There is no way around it. The nice thing about software is that once a bug is discovered it is just a one time fix. Once the bug is fixed, that particular bug “should” never occur in the future.
That cannot be said about human error. Sure if you’ve made an error in past, you’ll be less likely to repeat that same error in future, however you can be guaranteed to never repeat that error.
Computers are logical and follow a specific set of instructions and will always perform the same task given the same input. Humans are less logical than that thus raising the margin for errors.
tsuris, she may have blurted that off the record and I cannot blame her. It’s not usability per se that we need to certify. It’s patient safety that needs to be looked at first and foremost.
Yes , yes. The words ring true. This is what its come to : an electronic healthcare circus complete with Doctors rationalizing death by the megabyte, Clancey the Clown in a cheerleader outfit and vendors serving cocktails. Hello Earth, are you there, is everyone brain dead?
Marg, HIStalk reported that about Judy F, from his usually reliable sources.
You are insightful__”I don’t see why out of all HIT products EHRs are the only ones that cannot stand scrutiny.”
I would add that CPOE evaded assessment of safety and efficacy. This has highly dangerous ramifications.
The HIT vendor community schemed the regulatory avoidance strategy for years, and recruited academicians (see earlier comment by someone about Tang) to whore for them, as long as their departments and “education societies” got industry funds. Some truly liked the kool aid, produced it and served it.
To wit, the Miller Gardner paper of circa 1998. There was never any self scrutiny which the authors assured. The Tang prsentation mentioned earlier is another example. He was not conflicted at all, now was he then and is he now??
Sham scrutiny evolved to seduce government officials. They did not vet the c$hit certification (was and still is a sham) and HIMSS infiltrated the government with shills.
With direct lines to the White House and Congress, this white collar crime syndicate has been successful at accessing $ billions of taxpayers’ dollars. The crap they are selling is scandalous. Does anyone recall Teapot Dome?
Not Exactly Death,
I have listened to most of ONC committee meetings, and I don’t have a recollection of Ms. Faulkner ever saying such thing on record. Maybe somewhere in a hallway or by the water cooler.
In any case I don’t think attaching “usability” to certification of EHRs will even begin to address the problem discussed here. EPIC got 5 stars usability ratings from CCHIT very recently and so did most vendors that applied (see my previous post here on EHR Usability – https://thehealthcareblog.com/the_health_care_blog/2010/06/ehr-usability.html ).
Usability is just one factor affecting patient safety and it cannot easily be “tested” in a couple of hours. Pre and post market lengthy observations would be much better, and a place to report adverse events is a must. If drug manufacturers and other HIT product vendors can live with such constraints, I don’t see why out of all HIT products EHRs are the only ones that cannot stand scrutiny.
Not exactly death. Your blog readers could be the judge:http://hcrenewal.blogspot.com/2010/05/did-epic-ceo-judy-faulkner-of-epic.html
It seems to me that this is an experiment by the vendors, partner hospitals, and HIMSS for which the patients and physicians have not signed consent.
There is not a place to report adversity. There are “do not disclose” requirements according to Koppel and Kreda (JAMA).
There are intimidating and bullying coercion tactics by hospital administrators. There is sham legitimacy given by HIMSS’ CCHIT non profit in the form of a “certifiacte”. What gives?
I have an answer for all of your questions. Haha, its another question.
Why not let HIMSS decide everything for all of us. After all they control so many seats in government with all of there quartering soldiers on the ground and careful eyes on every aspect of the stakeholder battlefield that MAY AFFECT their stakeholder interests, the Electronic Health Records Association. The current situation is much like the movie “IRobot”. For all the help the AMA has given us on the issue, get real people! The Docs hide in closets afraid to speak while playing their favorite game – Who wants to be a millionaire? That game starts in pre-med and should be re-named ” the mushroom that wants to become a millionaire”. Let the rain fall. The mushrooms need a nice dark, moist environment and lots of crap.
uh-oh, I don’t think we can know if this is the tip of the iceberg or half of the iceberg. Obviously this is not the entire iceberg and it would behoove us to have a mandatory reporting system.
Of course, such reporting would expose hospitals to law suits that were not contemplated before. I am not sure what the solution should be.
The case in the article could have probably happened on paper too, even though I must say that it is less likely to make such error if you just write it down as opposed to typing 1.25, selecting units, and then selecting a frequency from a very long dropdown. Sometimes you think you selected one thing, but if your cursor was a bit lower or higher, you end up with a different selection, and unless you have the luxury of time to go back and recheck, you won’t really know you made a mistake. I don’t know if this is what happened there, but it is a very likely scenario.
Dear Margalit,
Dr. Shuren, CDRH Director, stated that the reports on the MAUDE site are the “tip of the iceberg”. Those reports are being sent to MedWatch even though there has not been a formal request or notification to physicians and nurses that adverse events from and dysfunction of CPOE devices and EHRs are to be reported to the FDA.
At present, there is NOT anyplace to report the adversity (to the delight of the vendors and hospitals with whom they partner).
Going further, this is amplified by threats, direct or implied, of reprimand for “disruptive behavior”, to potential health care workers who report HIT injuries and deaths to any agency outside of the hospital.
Just noticed this: http://www.pittsburghlive.com/x/pittsburghtrib/news/s_685300.html?_s_icmp=networkbar
Were there malfunctioning computerized dose checking devices, other electronic instruments involved with ordering, or merely cognitively confused (by the pages of computer gibberish) or decorticated over worked health care workers?
Uh Oh!
This should have been reported to the FDA database. I don’t see why it wasn’t since it is already in the public domain.
Perhaps “voluntary” reporting for public good is not enough of an incentive, and perhaps, as Dr. Luzerne writes above, this is not specific to HIT issues.
It takes time to enter data. My hospital EHR boatanchor has every little thing documented by even nursing assistants, such as “patient given water”. The nurses enter everything by check box with short little meaningless notes. When I ask for a piece of information that I specifically requested be gathered the response to me is “I put it in the computer”.
I have to find it!!
Time at the keyboard is time not taking care of anyone, whether by me or by a nurse.
EHR has transformed what it means (to the hospital admin) what it even means to be a good nurse.
Our average length of stay in the ED increase by a full hour when we turned on the boat anchor. The graph was breathtaking. It has been more than a year now, so the transition has aged out of annual graphic presentations.
People sit in the waiting room longer.
Of course not all the data is correct. But it is forever.
Doctors do not document in real time. To try to do so is foolhardy, dangerous and impossible.
Nurses are documenting in real time. This means less care per hour and more garbage per hour. The nurse is on the lookout for punctuation errors more than a change in the patient.
Do I really have to answer the question directly? Of course these devices are killing patients.
The cost of care will climb like a homesick angel just to cover the decreased capacity of care available per unit of time and the value will be greatly decreased.
Here’s an example of a patient being killed because of serious faults in the “people, process and technology” at what claims to be a technology leader among all healthcare organizations:
http://www.cdph.ca.gov/certlic/facilities/Documents/HospitalAdministrativePenalties-2567Forms-LNC/2567Kaiser-Oakland-Event4OG511.pdf
After reading the linked article, would any of you want a loved one to be brought to Kaiser Permanente’s Oakland ER if they needed care?
Sorry. The correct link is http://medkaz.com
Margalit, the breakthrough technology you allude to already is here. And an IT system that will fill the information gap you describe and facilitate real care coordination, will be here soon. It’s called the MedKaz™ (http://medkaz.com).
Do EHRs kill? You ask. I show.
10x insulin error built in to the device: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1060683
For readers not familiar with medication for diabetics, yup, this kills.
Mary, thank you for the great article.
I think Mr. B’s experience though points to another huge misconception that is slowly gaining track amongst experts, as exemplified by Prof. Christensen’s latest book (The Innovator’s Prescription). The thinking is that EHRs will be capable of providing the necessary “glue” to allow the health care system to further fragment (specialize) itself into more cost effective units of care. This hypothesis on which much of the future innovative models are built is questionable to say the least.
I tend to agree with the multiple MDs commenting on Mr. B’s story, that what he really encountered, other than a lack of IT interoperability, was a fragmented care system where his personal physician had no privileges at the hospital and thus just shipped him to the ER with a copy of his records and everything went downhill from there.
Gone are the days when his doctor would have been the one admitting him and continuity of care would have been a given, instead of an elusive idea which is now expected from IT systems.
I think it is very possible that IT systems will one day be able to fill this gap, but we are not there yet and forcing an “innovative” business model, when the breakthrough technology is not yet there to support it, will prove very harmful to all involved, patients in particular.
Correct link for Joe’s report:
http://www.syleum.com/2009/03/17/healthcare-data-model/
John’s link to Tang directs people to consider conflicts and hijacking of the taxpayers.
The distinguished Tang (appointed to the prestigious IOM) is Vice Chair of Blumenthal’s Policy Committee at ONCHIT and has ties (probable ownership in) to EPIC (VP EPIC Research Institute)and self interestedly promotes EHRs and CPOE.
Another EPIC leader with dual conflicted roles is Carl Dvorak, also a notable at HIMSS, the HIT vendors’ profitable non profit trade group.
This patient, Joe B., suffered at
Stanford, describing his experiences at Stanford at this link. http://www.syleum.com/2009/03/17/healthcare-data-model/If you do not believe this occurred at Stanford, call Joey B.
The computerized system to which he refers belongs to EPIC and Stanford and Tang and Dvorak and Judy F (Judy F said something about usability recently at an ONCHIT Policy Committee Meeting))
Do EHRs kill people? Joey B. is a person but he did not die. Almost, but not quite.
et’s hear from this team of conflicted self interested Stanford and EPIC experts as to what they did with Joe B’s complaint.
Lastly, the paper you cited earlier from Stanford about CPOE and babies may have been ghost written by EPIC but we will never know.
This country has a costly mess on its hands, not only in the Gulf of Mexico.
Written by Margalit____praetorius, I did read all the injury reports and read and reread the death reports in the Huffington Post, after which I ran my own queries in MAUDE for validation. I am not at all trivializing these reports. As far as I’m concerned even ONE single death should trigger a protocol to ensure it doesn’t happen again.
BTW, I haven’t seen any official responses to Senator Grassley’s letter. I thought the vendors had until February to respond. Did you see any replies anywhere?____
It behooves Margalit, fellow bloggers, and readers to call the good Senator and extend your query to him.
Do vendors ever honor dead lines?
Does anyone out there believe that the responses of the HIT vendors (or the hospitals) will show any more honesty than those offered by BP?
The vendors likely wrote the response for the hospitals to maintain consistency.
Here’s a link to Paul Tang’s testimony when he was first employed by both Epic Systems Corporation and the Palo Alto Medical Foundation: http://www.ncvhs.hhs.gov/981209t2.htm
Lawsuit re: unusual death within 6 weeks of a CPOE go live considers neglect_http://www.pittsburghlive.com/x/pittsburghtrib/news/cityregion/s_611120.html
Thank you, thank you, thank you, for bringing this topic to the front burner. EHRs may not kill but that is not the case for CPOEs.
Ever since CCHIT certified CPOE was installed as the panacea for health care at my hospital, there has been nothing but tsuris.
The hospital anxiously wanted to get a “Leap” recognition from HIT industry associated “Leapfrog Group”, which counts CPOE as a giant “Leap” for hospital safety.
There have been wrong medications, wrong doses, missed medications, whimsically stopped medications by the CPOE, duplicate medications, missed lab tests, CPOE cancelled radiograph tests, interface failures, failed communications, delays on stats, lost specimen, wrong test run on specimen, delays in routine medications, confusion about when to start a medication, missed nursing orders, failed reconciliation, false alerts, pharmacy confusion, drip rate confusion, incorrect medication lists, insufficient documentation, and patient neglect resulting in need for rapid response teams rushing to the bedside. These are not reported by the hospital nor are the software failures.
Staff wait on the useless help desk for many minutes.
I do not know how I can trust the system to yield safe care to patients. The errors do not stop. There is not time to report them.
The computer is always doing something adverse idiosynchratically because of some software glitch or weird default some non medical person coded in there.
I may lose my job but from my vantage point, the sole salvation for this ill conceived system of order entry, before it kills thousands, is for it to be submitted to the rigors of approval by the FDA as a Class 3 device.
I am interested to learn of a hospital CPOE system that works better than what is described. Be honest, now!
Bev is not aware of the extent of the problems with CPOE because doctors and nurses have been warned not to complain, threatened with job loss and other retaliation. The news of the dangers should have been available years ago but it has been covered up by hospitals and vendors, and the lay press does not understand how computerized care can be a killer. Kool aid has been served by the industry and its agents, HIMSS, EHRVA, CCHIT, etc.
Similar sociological events occurred with stenting. The cardiologists fees supported entire university departments of medicine and the corner suite administration. All are feeding at the trough of stents. The so called stent thought leaders were conflicted and lay press loved the idea of opening closed arteries, even though there was not a mortality benefit nor did the stents prevent heart attacks, unless the patient was having a heart attack.
Bev, can you imagine being on the faculty of a heart centered university academic department and formally issuing a complaint to the cardiology chief that stents were being deployed inappropriately, 35% of the time? You would be “by by”. At one facility, an appropriateness committee was disbanded by the administration and cardiology division chief.
Complainers faced the threat of sham peer review by “peers” paid by the administration to keep the registers cachinging.
Let me just play devil’s advocate here. Physicians are saying that CPOE (among other EHR uses) is unsafe, and we should not rush into its further implementation without evidence. Fair enough.
But what about the coronary stents which were widely, enthusiastically and heedlessly deployed into patients far beyond the limited group which received FDA approval, with associated morbidity and mortality? This went on for some years before studies were available demonstrating they were no panacea and even killed people with late thrombosis.
Where was (or, is) the widespread condemnation from within the profession that we are seeing here?
Phrasing the question another way – is it really the CPOE you are mad at, or having it shoved down your throats by an outside entity, namely, the suits and the feds?
Please look in the mirror and think carefully about this issue. I say it not to defend EHR’s,but to ask fellow colleagues to look at all new medical fads with the same degree of healthy skepticism. I fear, sometimes, that both our enthusiasm and our skepticism can be misplaced.
The Stanford study used flawed methodology. Shocking that the editors of Pediatrics missed this.
It is confounded by the 18% reduction in mortality from the deployment of rapid response teams which were reported in an earlier study by the same authors during overlapping time frames.
Teasing out the data, the deployment of CPOE may have caused increased mortality at Stanford but was mitigated by more effective use of the RRTs to get the neglected patients out of trouble.
uh-oh and Kickback, in the interest of fairness and objectivity, I don’t think we can label what happened in 2005 at the University of Pittsburgh as “CPOE baby deaths”. We cannot be 100% certain that the CPOE was the source of spike in mortality, just like we cannot be certain that the decrease in mortality at Stanford 4 years later was solely due to the new CPOE system.
Maybe other changes to operations occurred simultaneously as one of the commenters on that link you posted stated (a centralized pharmacy system was also introduced). The same is true for Stanford. What else did they change, other than CPOE?
Or maybe the process of implementing CPOE was flawed in one case and better in the other. Or maybe the 2005 product was not as good as the 2009 product.
As to the kickbacks, those are always nasty.
The bottom line is that we must design and execute quality studies.
Dr. James, you bring up a point that is extremely pertinent. Can we even isolate the effects of a hospital EHR enough to attribute adverse effects to it? The EHR is not just one precision tool. It is a system wide phenomena. If the nurses indeed tinker with the computer for inordinate amounts of time and as a result many little tasks are neglected, or their full attention is not with the patient at all times, it seems almost impossible to pinpoint the root cause of a particular event. At least not enough to be able to report it.
They should probably incorporate post deployment workflow studies to assess any general deterioration in patient care, but hospitals would have to lay aside the fear of litigation if any of this is going to be put in practice. I don’t really know how we do that.
I have to agree with bev, we need a strategy in place sooner rather than later.
About the CPOE baby deaths reported in the journal “Pediatrics” from Pittsburgh Children’s Hospital using equipment that was not tested for safety and efficacy. I wonder if the parents signed informed consent forms to have their kids’ care managed by CPOE.
Lawyers: Take note of this conflict when you are representing plaintiffs’ wrongful deaths in Pittsburgh:
http://phx.corporate-ir.net/phoenix.zhtml?c=118401&p=irol-SECText&TEXT=aHR0cDovL2NjYm4uMTBrd2l6YXJkLmNvbS94bWwvZmlsaW5nLnhtbD9yZXBvPXRlbmsmaXBhZ2U9NDAzNTMyNyZhdHRhY2g9T04%3d
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
On December 15, 2005, the Company issued 2,251 shares (pre-stock split) of its outstanding stock to University of Pittsburgh Medical Center upon exercise of a warrant granted in 2000. The aggregate exercise price was $101,717.06, or $45.1875 (pre-stock split) per share. The shares were issued by the Company without registration in reliance on the exemption provided by Section 4(2) of the Securities Act.
Additionally, and as previously disclosed in the Company’s quarterly report on Form 10-Q for the quarter ended July 2, 2005, on April 6, 2005, the Company issued 72,536 shares (pre-stock split) of its outstanding stock to University of Pittsburgh Medical Center upon exercise of a warrant granted in 2000. The aggregate exercise price was $3,277,720.50, or $45.1875 (pre-stock split) per share. The shares were issued by the Company without registration in reliance on the exemption provided by Section 4(2) of the Securities Act.
Page 29 Form 10 K Securities and Exchange Commission
The answer to your question, Margalit, is YES. The whole country is affected.
The deaths develop via primary, integral, and derivative mechanisms spanning a spectrum from defects in the software running the device, to erroneous computer transformation of orders, to results sent to the EHR but who knew, to neglect of the patient, and to adverse effects on care when the electronic ordering and record system in the entire hospital goes down.
Daily, the nurses focus their attention on the user unfriendly screens allowing the patient to be neglected. The deaths and other adverse events just happen unexpectedly. The users are conveniently blamed by the vendors, the HIT proponents, and the hospital administration who partnered with the vendor upon purchase.
Aside from the force of the contractual do not disclose clauses, the HIT industry has schooled hospital administrators elaborately to universally proclaim, when every screen goes blank and all medical records have vanished,”but it did not have any effect on patient care”.
How is that possible if these devices are so important, or why were the patients in the hospital in the first place?
Why have these devices avoided the safety and efficacy vetting specified in the F D and C Act?
The reason why there has not been the usual vetting for safety and efficacy by the FDA stems from the influence peddling at the level of the White House in this and prior administrations, and the meet, greet, and eat “capture” of HHS Secretaries by the industry, resulting in instructions to the FDA.
Interactions between industry and the FDA have also been known to occur.
Thanks, Margalit, for the article. I recommend it; it’s actually pretty interesting and provides a good overview of why we want EHR’s in the first place, but how to overcome their dangers. For those with short attention spans, the regulation part begins about p. 138.
One point they make is that oversight of EHR’s will have to continue for their lifetime in a given institution/practice,due to updates and customizations. Food for thought.
I am now convinced this regulation needs to become front and center in the HIT discussion NOW – before these systems become widely implemented complete with their existing known flaws. Trying to do it retrospectively would be a total nightmare.
Already in the comments of this post there have been 3 bad links posted. Presumably by computer literate, highly educated professionals. And you ask if EHRs can kill. If humans are operating and programing them, I think so. So they should be regulated and studied by some federal agency.
Oldie but Goodie_Background on the CPOE facilitated baby death rate at UPMC Children’s Hospital in the words of faculty:http://doctorandy.blogspot.com/2005/12/uh-oh.html
Were these deaths reported to the FDA and if not, why not? Did the babies not die? Is this a fable?
“This EHR terribly inefficient, and it often gets in the way, but it is surely powerful, and indubitably better than handwritten notes and paper charts.”
Dr. Johnson, this pretty much sums it all. We just need to harness that power and direct it towards positive goals safely.
praetorius, I did read all the injury reports and read and reread the death reports in the Huffington Post, after which I ran my own queries in MAUDE for validation. I am not at all trivializing these reports. As far as I’m concerned even ONE single death should trigger a protocol to ensure it doesn’t happen again.
BTW, I haven’t seen any official responses to Senator Grassley’s letter. I thought the vendors had until February to respond. Did you see any replies anywhere?
This is an important discussion; one of the misconceptions in the public (and professional) view is that the Venn diagram of paper and electronic records is essentially non-overlapping. Either can be a haystack of data; either can be a well-organized tool that aids decision-making.
Let we forget, the core of health care is professional evaluation and decision-making (at all levels).
The best role of any medical record is to *organize* and present facts that are too important to trust to memory, in a way that speeds their re-discovery when needed, and presents it in a manner that facilitates analysis (e.g., flowsheets).
Most medical records of both types, in my experience, seem primarily to be loosely organized haystacks. We have had more than 30 years of experience during which physicians have failed to create a medical record that supports well the intellectual task of organizing each patient’s information relevant to the complaints at had. This would be an arduous but feasible task, to create such an expert system.
As pointed out, some errors and omissions of EHRs are characteristic of the design of individual vendors’ products. For example, PowerChart does not list med allergies on the meds list/prescribing function, and does not list the patient’s preferred pharmacy during the prescribing process while often offering an incorrect default. As a result, when our clinic adopted it, we went from rarely sending an Rx to the wrong pharmacy, to doing so many times a day.
In the hospital, nurses now spend 10 hours a shift shoveling reams of data points into small holes in the electronic record, while flow-charting is impossible and the record presents to the physician only the most superficial “rounds report” of data. Meanwhile, nurses have not been taught to make clinical notes (there’s no time left, for one thing), and so physicians do not have the benefit of seeing the sequence of nursing clinical judgments that once flowed through the nursing notes, shift by shift.
On the other hand, once a problem list has been well completed, it’s there for good; all notes are legible; labs can be quickly graphed. This EHR terribly inefficient, and it often gets in the way, but it is surely powerful, and indubitably better than handwritten notes and paper charts.
bev, I can get to the article, but I downloaded a copy for you here: http://www.onhealthtech.com/resources/22HarvJLTech103.pdf
rbar, I agree. We will have to find a way to distill information, or better yet make a modest start and only transfer pertinent data. If an ED doc or even a specialist is faced with hundreds of notes and a litany of meaningless Dx, chances are they won’t even look at it. I’m not expecting RCTs, but there must be other ways for instances where RCTs are impracticable.
Bad_informatics, even worst case scenarios need at least some real measured data. I’m afraid that when it comes to EHRs we don’t have enough reliable information to extrapolate anything. However, we do know that deaths have occurred and just like James’s ambulance article, I would expect investigation and, more important, research into ways to make such accidents less likely.
Margalit,
I do not believe that you had the time to search and read each adverse event report and defect recall of CPOE and EMR devices on the FDA data base for you to trivialize the cases and shrink their significance.
Your readers, if not already aware, can learn of the conflicts which enable unfettered deception by the HIT industry: http://huffpostfund.org/chart-sen-grassley-questions-hospitals-vendors-about-ehr-programs
This list does not include the legions of people tied to the industry trade group HIMSS and its daughter, CCHIT, working for the US Government, taking up tax dollars to continue the obfuscation.
The foundation of deception is available here. The conduct may border on the criminal: were there kick backs for the “opinion”? http://www.washingtonpost.com/wp-dyn/content/article/2009/05/15/AR2009051503667.html
correct link to comment above was http://hcrenewal.blogspot.com/2010/04/if-benefits-of-hit-can-be-guesstimated.html
Note that the article at http://hcrenewal.blogspot.com/2010/04/if-benefits-of-hit-can-be-guesstimated.html%20 was acknowledged as a thought experiment, a worst-case scenario.
Akin to the worst-case projections of what would happen if a major underwater oil well blew and leaked for months on end, something that could just never occur.
BobbyG:
‘For example, fundamental to the concept of the “patient-centered medical home” trial initiatives now getting underway is the argument that primary care docs should properly be seeing no more than 8-10 patients per day.’
Not correct. If you read the fine print, all the “research” about the PCMH supposes that the doc actually spends LESS time with each patient, in order to cover the enormous overhead that is involved.
Look at the recent report on the AAFP’s Transformed project: its a disaster. The finances are unworkable!
Don’t criticize the FDA MAUDE database. The injuries and deaths are real. Doctors and others should be reporting. They experience retaliation if they do. Health Care Renewal estimates are representative. The HIT industry has used HIMSS and C$HIT to deceive the Executive and Legislative Branches of the US Government.
Interesting discussion that omits one point: there is great effort going into implementation of EHR – is that a worthwhile effort? I believe it is, at least in large institutions (for instance, academic system or large MSG; probably the biggest bang for the buck is at the VA that has a nationwide system, although my knowledge is limited as I did not work there since residency). A randomized will never happen (and I am not sure whether it was feasible at all, or its results generizable).
The biggest problem I see is drowning in poorly managed data, a problem that will obviously increase over the years. For instance, problem lists that, for the same patient, contain duplications like osteoarthritis, DJD, joint pain, knee arthritis, joint pain. Or records that list 120 notes for a given patient, but the highly valuable ones (e.g. 1st time consultation) are hard to separate from the insubstantial ones (pt calls and asks for off work note). Some systems are doing better with regards to the latter then others.
BobbyG;
I have tried on 3 different computers to access the article you cited, and can’t get in. I can’t even access the jolt.law.harvard.edu site at all. Is anyone else having this problem? I’d really like to read the article. Why did they say the FDA was not a viable choice?
Yes James, ambulances kill people and cars in general do too and airplanes and trains and faulty surgery and diagnostic equipment as well.
But all these things are tested for safety and are under the supervision of regulatory bodies. There will always be accidents even with the best regulated systems. However, as your article clearly indicates, one hopes that safety regulations significantly decrease the likelihood of such accidents. Why should we take a different and completely unsupervised approach with EHRs?
At the very least we should have some post market research done and if it shows that there are no significant hazards associated with HIT then we will know that nothing needs to be done. We don’t have such research.
bev brings up a very important aspect as well. The biggest danger is probably during implementation. Maybe, at the very least, there should be some best practice guide lines on how to introduce HIT safely.
It seems that although there may be significant growing pains with EHR the current system is not the answer. It seems we must move forward as quickly as possible.
Ambulance crashes kill patients every year:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5208a3.htm
However, the alternative of not using ambulances for emergency transit is clearly one that results in more fatalities.
We are told repeatedly that the status quo of medicine (IOM Report most frequently cited) is 100,000 preventable deaths a year. This is occuring under our largely paper-based world.
@Robert Forster –
I hear you. Let me re-post a comment I made the other day on another blog:
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“I would just observe that, absent significant payment reform (I won’t be holding my breath), there’s a very real problematic barrier to effective EHR use if we don’t change the basic paradigm. For example, fundamental to the concept of the “patient-centered medical home” trial initiatives now getting underway is the argument that primary care docs should properly be seeing no more than 8-10 patients per day (e.g., think about the typical hour attorney consult visit), that the customary 25-30 pts/day is driven by the need to bill, to keep the doors open; that roughly half of outpatient visits are of marginal to nil clinical value.
I and one of my REC colleagues did a clinic assessment visit the other day. We interviewed 4 docs, one of whom was a severe “Dr. NO!” on the topic of HIT. His beef was basically a “productivity loss” complaint, i.e. that seeing mostly older, complex problem list pts (he’s Internal Med) made it nigh impossible to effectively chart electronically within the scheduling constraint.
Now, perhaps with a lighter, more rational daily patient load (and more extensive EHR training) he might come around and truly “adopt.”
I consulted with an attorney a couple of years ago regarding legal guardianship over my dementia-addled (now late) Dad. The initial hour cost me $300. The entire deal ended up costing about $4,000.
A physician, however, is supposed to take in myriad data and make a comparably expert decision in 15-30 minutes — and hope he/she can eventually get reimbursed a relative pittance.
It’s crazy.
So, OK, where are we? We’re facing a current and projected shortage of perhaps 40-50,000 primary care docs, and under PCMH theory we propose to cut their pt volumes in HALF or more so they can provide better care? All while bringing tens of millions of the previously uninsured into the (non-ER) system under Obamacare reform.
Right.
I don’t have a good answer for the skeptical docs who argue that the EMR gold rush is more about billing imperatives and vendor welfare, that the docs’ pt care-analytic needs are a distant 3rd at best.
It’s a vexing circumstance.”
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Absent a coherent, comprehensive systems view, we can just expect more pain and frustration and failure.
Great article Margalit. I have an itch that does not go away with scratching. I ask, does a box (check list) format for physicians seeing elder or complex patients with more than 1 disease improve or hinder quality physician decision making. Being an old internist I am biased that guidelines can be great for single disease persons/events. Yet almost non relevant when other diseases are present, e.g. CHF, and renal insufficiency. The integration of complex diseases is the essesence of problem solving–yet a check the box format may hinder that inguizitive/intuitive physician thinking process. Last time I saw my doc he spent 8 minutes looking at the computer (making sure each box was checked=I call “euboxic”) and 1 minute at me. I guess non verbal clues are no longer important (we know that is not true). So, EMRs/EHRs will have some unintented consequences-not all good in my mind. Maybe it is just the transition–but I miss and now appreciate the physician/patient visual exchange and relationship. RobMD
Sorry, wrong link for Pittsburgh.
Here is the correct one: http://pediatrics.aappublications.org/cgi/content/abstract/116/6/1506
Anon (second Anon), the Pittsburgh study was done in 2005 after a hospital wide CPOE system was installed in 6 days (?!). That’s a long time ago. For every Pittsburgh style study there is a Stanford style study, this one much more recent – 2010), showing contradictory results, i.e. CPOE decreased mortality.
Personally, I don’t have much confidence in either one, since the results cannot be directly linked to the CPOE system while completely eliminating all other factors. This is particularly true for increased mortality rates with no individual CPOE errors reported, or at least documented.
The point here is that research needs to be done and regulatory bodies, whether FDA or CMS or something new, as BobbyG points out, need to be involved on some level.
And Anon 1, instruments and devices used in surgery are regulated.
Pittsburgh Study – http://pediatrics.aappublications.org/cgi/content/abstract/peds.2009-3271v1
Stanford Study – http://pediatrics.aappublications.org/cgi/content/abstract/peds.2009-3271v1
Do EHRs kill people? Of course they do! The question is do EHRs kill more people than no EHR. How do you write this post without mentioning the increased mortality seen at Childrens Hospital of Pittsburg after EHR implementation? And not a small increase – from 2.8% to 6.6%. Until more hospitals report their data, I will conclude that EHRs kill more people than no EHR.
After a dozen plus years working in health information technology, I have yet to see any vendor or any hospital thoroughly test an EMR. I doubt this experience is unique to me.
See “FINDING A CURE: THE CASE FOR REGULATION AND OVERSIGHT OF ELECTRONIC HEALTH RECORD SYSTEMS”
http://jolt.law.harvard.edu/articles/pdf/v22/22HarvJLTech103.pdf
Sharona Hoffman and Andy Podgurski looked at the case for FDA regulation of EHRs, and decided it was not viable. They argued that either CMS do it, or that a new federal regulatory entity be established. The latter would be a very tough sell politically, and would take too long to get up to speed.
Tough issue.
“Does surgery kill people?”
Why, yes, it sometimes does.
But medicine is much better off for having it.
Same with EHRs.
What a great post, Margalit. And fair warning to all those who post here that EHR’s kill people – if you have seen that happen, then report it! Or you will get the kind of unsupportive data shown here. Medicine no longer is run by anecdote.
I was also unaware of your link, which at least shows the FDA is considering it. It would be a massive job and require more staffing, no doubt.
I would like to add, however, the factor of injuries/deaths caused during the implementation of an EHR, particularly a difficult or failed one (all of us have examples of that). When my hospitals implemented our new lab system some years ago and it initially failed (due to our own mistakes as well as the vendor’s), I am positive that we killed some people during that time – but it was way too chaotic to identify and report individual cases. The FDA can’t regulate poor planning and implementation, unfortunately. I think enough bad things have happened that hospitals are getting wise now in terms of implementation, but it is still an issue. Doctors’ offices beware – you need a real, specific plan.