Ross Koppel challenges feckless academics on poor health IT design

The academic health IT community has spent the past decade (at least) burying their collective ostrich heads in the sand about the crappy software that is called health IT.

A few, though, have taken on the health IT industry at the heart of bad health IT design (including yours truly, which sadly was not enough to save my own mother from health IT design defects).

Probably the bravest soul on these issues, however, is Penn sociologist Ross Koppel.  In a critique of the latest from the medical informatics academic community on reigning in the hazards of this technology, an article by Sittig and Singh at U. Texas, he wrote the following piece in the BMJ:

The health information technology safety framework: building great structures on vast voids
http://m.qualitysafety.bmj.com/content/early/2015/11/19/bmjqs-2015-004746.full.pdf

Download it and read it in its entirety.  It makes the point that the solutions to these problems (which I increasingly believe just might be an insoluble, wicked problem without major scope and ambition reductions regarding the use of health IT) must be based on reality.

The reality must start from a firm response not to end users being flummoxed by bad rollouts or by carelessness (user error), but to the issue of products poorly designed from the get-go by their sellers whose primary interest is to make money come hell or high water.

Koppel makes the point that one will not get good results driving a car if that car is designed poorly, with hidden and confusing controls, defective brakes and an engine that overheats and explodes without warning, no matter what post-design interventions take place.

The issues of design flaws and fundamental fitness for purpose need to be blown open in a manner similar to the manner in which drugs and other medical devices are evaluated and regulated.  Academia needs to lead the charge, not suggest band aids, however well intentioned those band aids might be.

Koppel writes:

 ... In essence, I suggest that these two eminent colleagues tell us to look under the lamppost even though, as the old saying goes, the keys were dropped 70 feet away from the lamppost in the dark. Both Singh and Sittig, of course, are fully aware of the errors listed above,3 4 but (1) they expect that we can detect and understand these problems with error reporting, although many potentially serious errors go undetected (thus, unreported), and when detected, the poor design features that contributed to the error may not be readily apparent. (2) Singh and Sittig tend to attribute those sorts of problems to poor implementation, user errors or lack of access to the technology. They do not seriously question if the software is fit for its purpose.

And this:

 ... In fact, their assumption that HIT software is well designed runs throughout their work. They write about: misused software, unavailable software, poorly
implemented software and malfunctioning software (emphasis added), but what of badly designed software—neither user friendly nor interoperable with systems holding needed patient data? That failure is
not in their purview. They don’t challenge HIT vendors who design the software, or the regulators, who so often serve primarily as HIT industry promoters. Here’s what they write we need to address (my
italics): ‘1) concerns that are unique and specific to technology (e.g., to address unsafe health IT related to unavailable or malfunctioning hardware or software);
2) concerns created by the failure to use health IT appropriately or by misuse of health IT.

I add that such articles tend to confuse policy makers about what truly is needed to solve problems with HIT.

I've had the guts to take on these issues via the legal route after the death of my mother, something that led a number of academic zealots to intone that the incident, in 2010, a decade after my writings on bad health IT began, caused me to lose my objectivity.  That puerile, perverse reasoning passes for wisdom in certain academic informatics circles.  Yet it appears their objectivity about health IT never existed.

I lack respect for paper writers who in effect become apologists for products birthed as dangerous right out of the gate by opportunistic health IT companies.  Perhaps the health IT-mediated death of one of their loved ones would wake them up, but I sometimes doubt even that.

This is no mere academic spat. In this case, patient risk and harm worldwide is at issue.

The root of any software problem in healthcare, as I've written before, is at the design level.  Trying to work around bad design without facing reality leads to and perpetuates risk, patient harm, clinician disillusionment (e.g., the Medical Societies letter to ONC) and impairment of clinicians trying to take care of patients.

Kudos to Koppel. I hope the repercussions of his challenge to the usual academic fecklessness and special accommodations afforded this unregulated industry are not too severe.

Academics can be feckless towards possible sources of funding, but quite mean to internecine challenges, as Sittig, one of the authors of the challenged piece, was with me in an incident I found out about only because he did not know one of the people to whom he badmouthed me had been a former student I'd mentored.

-- SS

7:43 AM

Politico: Electronic record errors growing issue in lawsuits

The indefatigable Arthur Allen of Politico.com has authored a nice piece on the issue of EHRs being a cause of medical malpractice, with resultant litigation.  I was a contributor:

Electronic record errors growing issue in lawsuits
By Arthur Allen
5/4/15 6:40 AM EDT
http://www.politico.com/story/2015/05/electronic-record-errors-growing-issue-in-lawsuits-117591.html

Medical errors that can be traced to the automation of the U.S. health care system are increasingly an issue in medical malpractice lawsuits.

Some of the doctors, attorneys and health IT experts involved in the litigation fear that safety and data integrity problems could undercut the benefits of electronic health records unless HHS and Congress address them aggressively.

I already believe the benefits of EHR technology have been severely undercut - if not destroyed - by the unbelievably poor quality, user experience and incompetent implementations presented by most commercial health IT software today.

I even have a dead mother to offer as evidence, due to an ED EHR's lack of fundamental and crucial confirmation dialogs and notification messages to team members.  These computer science-101 level deficiencies permitted a triage nurse's failure to successfully click a heart medication for continuation to propagate through several days of ICU/floor hospitalization unnoticed.  Gross overconfidence in computer output and cavalier attitudes in the ICU about med reconciliation sealed the deal, where, recognizing something seemed amiss with the meds list vs. the history of arrhythmia, the ICU doctor did nothing except leave a question in the chart about it, resulting in catastrophe.

“This is kind of like the car industry in Detroit in 1965,” says physician Michael Victoroff, a liability expert and a critic of the federal program encouraging providers to adopt EHRs. “We’re making gigantic, horrendous, unsafe machines with no seat belts, and they are selling like hot cakes. But there’s no Ralph Nader saying, ‘Really?’”

There are, actually, but an "Unsafe at any MHz" has not yet been written and taken seriously by the public about EHRs.  The industry has been too in control of the narrative for that to happen.

According to a review by The Doctors Company, the largest physician-owned U.S. medical malpractice insurer, EHR issues were involved in only 1 percent of a sample of lawsuits concluded from 2007 through 2013. But that finding could be deceptive since it takes five or six years to close a suit, and during that period the numbers of such cases grew rapidly as electronic health records become more pervasive in hospitals and physician offices. The pace of these cases doubled from 2013 to early 2014.

At the linked report at http://www.thedoctors.com/KnowledgeCenter/Publications/TheDoctorsAdvocate/CON_ID_006908 the med mal insurer "The Doctor's Company" noted:

... Shortly after electronic health records (EHRs) began to be widely adopted, The Doctors Company and other medical professional liability insurers became aware of their potential liability risks. We anticipated that EHRs would become a contributing factor in medical liability claims. Due to the three- to four-year lag time between an adverse event and a claim being filed, however, EHR-related claims have only recently begun to appear. In 2013, we began coding closed claims using 15 EHR contributing factor codes (eight for system factors and seven for user factors) developed by CRICO Strategies for its Comprehensive Risk Intelligence Tool (CRIT).

In 2013, The Doctors Company closed 28 claims in which the EHR was a contributing factor, and we closed another 26 claims in the first two quarters of 2014. During a pilot study to evaluate CRICO’s EHR codes, 43 additional claims closed by The Doctors Company were identified (22 from 2012, 19 from 2011, and 2 from 2007–2010).

What is not stated is the fact that many EHR-related harms are not recognized as such; many injured patients do not sue, and many who want to cannot do so due to the expense and time involved for plaintiff's attorneys (I have heard the figure that perhaps 5% do make it to suit).  Along with the time lag noted, these figures are another Red Flag, as are the ECRI Deep Dive harm figures, representing what is likely just the "tip of the iceberg."

(See "Peering Underneath the Iceberg's Water Level" at  http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html and "FDA on Health IT Adverse Consequences: 44 Reported Injuries And 6 Deaths, Probably Just 'Tip of Iceberg'" at http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html).

Back to Politico:

The lawsuits allege a broad range of mistakes and information gaps — typos that lead to medication errors; voice-recognition software that drops key words; doctors’ reliance on old or incorrect records; and nurses’ misinterpretation of drop-down menus, with errors inserted as a result in reports on patient status.

In addition, discrepancies between what doctors and nurses see on their computer screens and the printouts of electronic records that plaintiffs bring to court are leading some judges and juries to discredit provider testimony and hand out big awards. In one case, a patient in septic shock had suffered gangrene and a severe skin rash, but computer records read “skin normal.” They also showed repeated physician interviews with the patient — when she was comatose.

I can verify both of these issues personally, from my legal work - not to mention outright electronic record tampering.

... While the percentage of EHR-related cases is still low, “this is going to become a bigger and bigger issue,” said David Troxel, medical director of The Doctors Company. “I get more calls from frustrated, angry doctors about their EHRs than any other subject.”

Doctors may be following my advice (see end of my post at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html) where I wrote:

... When a physician or other clinician observes health IT problems, defects, malfunctions, mission hostility (e.g., poor user interfaces), significant downtimes, lost data, erroneous data, misidentified data, and so forth ... and most certainly, patient 'close calls' or actual injuries ... they should (anonymously if necessary if in a hostile management setting):

(DISCLAIMER:  I am not responsible for any adverse outcomes if any organizational policies or existing laws are broken in doing any of the following.)

• ... Inform their personal and organizational insurance carriers, in writing. Insurance carriers do not enjoy paying out for preventable IT-related medical mistakes. They have begun to become aware of HIT risks. See, for example, the essay on Norcal Mutual Insurance Company's newsletter on HIT risks at this link. (Note - many medical malpractice insurance policies can be interpreted as requiring this reporting, observed occasional guest blogger Dr. Scott Monteith in a comment to me about this post.)

Back to Politico:

The industry “takes very seriously the need to enhance the well-documented ability of EHRs to increase patient safety,” an association spokesperson said. “It also recognizes the importance of looking for opportunities to identify and reduce any potential risks associated with development and use of EHRs. All these efforts are essential to the goal of learning more about the ways in which technology, training and configuration can be rolled out in the safest possible ways.”

This is pure B.S. and spin.  There is no "well-documented ability of EHRs to increase patient safety", just a number of methodologically flawed/biased studies (like this one, http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html), a lot of pro-HIT rhetoric, and a lot of harms data that the industry ignored for many years.

The statement also ignores what the domain expert end users - physicians and nurses - themselves are saying, see "Accenture - Fewer U.S. Doctors Believe IT Improves Health Outcomes (April 2015)" at http://www.businesswire.com/news/home/20150413005148/en/Increased-Electronic-Medical-Records-U.S.-Doctors-Improves#.VT5bmpOTqUk.

Why, one should ask as well, should an industry that's been around for decades only now be "learning more about the ways in which technology, training and configuration can be rolled out in the safest possible ways?"  

I see that statement as an industry self-condemnation of years of cavalier IT practice. 

... But providers and health care systems are eventually going to start suing vendors, analysts said, in part because software companies are viewed as having deep pockets. “It’s only a matter of time before a company like athenahealth or Allscripts or Epic or Cerner gets sued,” said Klein.

Plaintiffs’ attorneys are already eyeing such cases, according to Scot Silverstein, a Drexel University health IT expert and internist who is suing a hospital over a lapse in care of his mother that Silverstein claims was caused by poor EHR implementation. Silverstein and two plaintiff’s attorneys met with Rep. Matthew Cartwright (D-Pa.) and other lawmakers in November to plead for more government regulation of EHRs.

I was actually more direct with the author of the article, Mr. Allen.  I said that the sellers of these systems deserved to be sued - that they had earned it through slovenly practices in thought and application enabled by the extraordinary regulatory accommodations afforded to and protected by the industry since its inception (i.e., no regulation) - when system flaws result in patient harm. 

... Some recent studies show that EHRs do make hospitals safer. But the data isn’t conclusive, said William Marella, executive director of the ECRI Institute Patient Safety Organization. Last year, ECRI convened a partnership of EHR vendors, safety experts, academics and medical groups to share and analyze health IT problems ... EHR safety issues are frequently misdiagnosed — and thus under-diagnosed — by providers, according to ECRI’s Marella. “They say, ‘wrong site surgery,’ or ‘drug error,’ which can make it hard to ferret out the cases where IT is responsible.”

It is absurd and disingenuous to speak of 'safety improvements' when the true harms rates are admittedly unknown (see "FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html) for more on that issue.

... In about 200 EHR-related legal cases that the liability firm CRICO analyzed, the glitches rarely led directly to patient harm, said Dana Siegal, the company’s director of patient safety services. But she added, “We’re seeing failures to communicate or providers acting on inaccurate information that was driven in part by an EHR issue.”

This brings up another issue.  Computers don't pull triggers and the mayhem they cause doesn't usually immediately kill people.  My mother, for example, survived the initial EHR-led assault on her life, though her survival required emergency reversal of anticoagulation in the face of critical carotid stenosis that had already caused a TIA, emergency craniotomy (brain surgery), and other risky interventions.  She died a year later of complications of her injuries.  Her case would not be likely to be counted as an "EHR-related death" in any statistics (if it was reported at all).  This "time delay" would likely cause any statistics on EHR-related deaths to be understated on their face.

... While the effect of EHRs on malpractice suits is still modest, many analysts worry about the overall uncertainty concerning information in such systems. Confusing or inaccurate records, if they proliferate, not only cast doubt on a doctor in court but could taint clinical research that draws on these large pools of data.

Bravo to Arthur Allen for pointing out that clinical research that draws on garbage, uncontrolled data will turn out garbage.  See my paper "The Syndrome of Inappropriate Overconfidence in Computing" at http://www.jpands.org/vol14no2/silverstein.pdf for more on that issue where I observed:

... This increasing confidence in EHR data to perform far more complex tasks than postmarketing surveillance of a single drug is of great concern. Prompt detection of adverse drug events (ADEs) from single drugs, using aggregated EHR data, is within the realm of possibility. Detection of relatively more nebulous (i.e., compared to major ADE) “outcomes differences” between two or more drugs or treatments via EHR data—such as, did treatment A lower blood pressure more than drug B, or did drug C lessen depression more than drug D—rises to the level of “grand overconfidence in computing” and perhaps “grand folly.”

To accomplish this task with reasonable scientific certainty from aggregated EHR data originating from different vendor systems, input by myriad people of different backgrounds, with differing interpretations of terminologies (students/residents/attending
MDs/RNs etc), under different pressures and motivators (time limits, cognitive overload from poor HIT user interfaces, reimbursement maximization, and so forth), seems improbable.

What levels of statistical validity could arise from such studies? Could they even approach the level deemed “acceptable” in good science?We do not know, although I suspect a “garbage in, garbage out” (GIGO) phenomenon, leading to studies whose results are more likely related to chance than to solid reality.

Back to Politico:

A recent report by the HHS Office of Inspector General said the department has failed to assure that EHR data are secure and accurate. Many hospitals have unsecured audit trails—meaning that information in the record could be altered without detection, it said.

This ability - to alter records - has been admitted under oath by EHR systems administrators in cases in which I have been an advisor to the Plaintiffs' attorney - and had the questions asked.  Hospitals have possession and control of easily-alterable information (far easier than paper) that is the only evidence of potential misadventures - a major conflict of interest.

... “There’s really no one with a vested interest in the integrity of the record besides you, the patient,” said Reed Gelzer, a physician and health IT expert.

Yes, but getting it can cost thousands of dollars.  I paid about one thousand dollars for a few reams of printed EHRs, and this is not uncommon.

... Concerns led the Institute of Medicine in 2011 to propose the creation of a dedicated IT safety center with the power to investigate EHR risks. ONC has since settled on a center that would have no investigatory power but would provide a safe environment in which real-life problems could be analyzed and solutions developed.

In other words, ONC has settled on a joke, on tension management.

The safety center is a “critical priority right now for ensuring the transformation from a world of paper to a world of electronics and connectedness,” said Patricia McGaffigan, COO and a senior vice president at the National Patient Safety Foundation.

Yes, a powerless, industry-friendly "safety center" is a priority for good reason.  Not to sound mean-spirited, but if the wife, child, parent of one of the proponents of a milquetoast "Safety Center" suffers EHR-related injury and dies a painful and lingering death as a result, as did my mother, the proponent will get little sympathy from me.   They've certainly tempted the Gods.

I will leave the final word to physician Michael Victoroff:

“The vendors are very right that if they had true product liability they wouldn’t make these things,” he said.

To which I say to the Information Technology vendors, if you can't take the heat (of accountability in medicine), then get the hell out of our medical kitchen.

-- SS

10:10 AM

Open Letter to Minnesota's Heath Commissioner Dr. Edward Ehlinger on ill-informed health IT puff piece

Minnesota's Heath Commissioner Dr. Edward Ehlinger penned a puff piece on EHRs entitled "Electronic health records advance quality care for all Minnesotans" (Minn Post, 4/23/15, http://www.minnpost.com/community-voices/2015/04/electronic-health-records-advance-quality-care-all-minnesotans).

It constains all the usual baloney (being kind here) about this technology:

It starts with this:

As Minnesota’s health commissioner, I work to improve the health of all Minnesotans. As a physician, I’m dedicated to providing the best care possible to patients. Secure electronic health records help achieve both goals by enhancing the safety, effectiveness, and efficiency of our health care system. With that in mind, I have been concerned to see some recent pushback on Minnesota’s requirement that all health care providers use electronic health records (EHR) by 2015 ... All Minnesota patients, whether they visit a small clinic, need mental health treatment, or receive care from multiple providers, stand to benefit from EHRs and the improved care coordination they make possible.

"Pushback", he writes?

The implication seems clear - 'fear mongering' by Luddite clinicians is responsible.  See my March 2012 post "Doctors and EHRs: Reframing the 'Modernists v. Luddites' Canard to The Accurate 'Ardent Technophiles vs. Pragmatists' Reality" at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html on that antediluvian, tired old issue.

Note also the terminology "stand to benefit" - a typical weasel phrase just in case things don't work out as intended.

Not mentioned are the harms.

Rather than plow through yet another puff piece by someone either misinformed or just way behind the current medical literature on this experimental technology, I provide the letter I wrote to Dr. Ehlinger and several other Minnesota cabinet members, including Commissioner Kevin Lindsey of the Dept. of Human Rights, Commissioner Lucinda Jesson of the Dept. of Human Services, and Chair Adam Duininck, Chair of the Metropolitan Council:

The letter:

From: Silverstein,Scot
Sent: Saturday, April 25, 2015 7:00 AM
To: health.commissioner@state.mn.us
Cc: info.mdhr@state.mn.us; dhs.info@state.mn.us; public.info@metc.state.mn.us
Subject: "Electronic health records advance quality care for all Minnesotans" - really?

Congratulations Dr. Ehlinger.  With your puff piece "Electronic health records advance quality care for all Minnesotans" (http://www.minnpost.com/community-voices/2015/04/electronic-health-records-advance-quality-care-all-minnesotans) you just flunked my introductory course in Medical Informatics.

Kindly refrain from writing on subjects about which your knowledge clearly lags common knowledge in healthcare information technology (IT).

You must not know about the following, although you should have known, or should have made it your business to know, about these at the very least:

1. ECRI Institute Deep Dive Study on Health IT risks (2012) http://www.healthit.gov/facas/sites/faca/files/STF_Deep_Dive_Health_Information_Technology_2014-06-13.pdf
2. Letter to ONC from 37 Medical Societies (January 2015)       http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf
3. Joint Commission Sentinel Events Alert on Health IT (March 2015)    http://www.jointcommission.org/assets/1/18/SEA_54.pdf
4. Accenture - Despite Increased Use of Electronic Medical Records, Fewer U.S. Doctors Believe It Improves Health Outcomes (April 2015)                     www.businesswire.com/news/home/20150413005148/en/Increased-Electronic-Medical-Records-U.S.-Doctors-Improves

I don't mean to sound insulting, but it is earned on your part.  My mother is deceased in 2011 as a result of an EHR error.

When did you plan on informing the citizens of your state about the risks of bad health IT?

Not giving your citizens opportunity for informed consent regarding the use of these medical devices in their care seems a violation of human rights.  The most impacted are the disadvantaged, who go to organizations with lesser budgets to make the IT work safely, I add.

Sincerely,

Scot Silverstein

----------------------------------------------------------------

Scot M. Silverstein, MD

Consultant/Independent Expert Witness in Healthcare Informatics (May 2010-present)

Adjunct faculty in Healthcare Informatics and IT (Sept. 2007-present)
Assistant Professor of Healthcare Informatics and IT, and Director, Institute for Healthcare Informatics (2005-7)
Drexel University
College of Computing and Informatics
(formerly College of Information Science and Technology)
3141 Chestnut St., Philadelphia, PA 19104-2875

I did not mention the horrible track record of breaches (e.g., as retrieved by query link http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy).  Close calls, maiming and death is enough for one letter.

It is truly unnerving to see a physician responsible for the heath of the citizens of an entire state so seriously misinformed.

-- SS

4:20 AM

Rideout Hospital, California: CEO Pinocchio on quality of patient care during hospital computer crash

EHRs and other clinical IT are touted as essential to improving safety, among many other benefits.

Yet when hospital systems crash, the common refrain by hospital executives to the press, when such stories are reported, is "...but quality of care was not compromised."  

In fact, I've made an indexing term for this refrain.  The following query link retrieves the posts so indexed, numbering almost 30 at present:  http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised

One hospital in California 40 minutes north of Sacramento had a crash and its CEO made exactly that claim.  However, a patient's husband disagreed, and called the CEO a liar.  Why?  His wife was affected by the crash in a very unsafe manner.

The Appeal-Democrat is a local news source for Sutter and Yuba counties, California, serving readers since 1860.  Emphases mine:

Letter: Re: Rideout Hospital computer problems

http://www.appeal-democrat.com/opinion/letter-re-rideout-computer-problems/article_4a408cc0-be47-11e4-9b7b-93c22da930d4.html 

Friday, February 27, 2015 

I am writing in regard to comments made by the CEO of Rideout Hospital regarding its recent computer crash. 

He said quality of care for patients had not been compromised during this incident. He is lying.

My spouse went to Rideout almost two weeks ago and had a Lexiscan of her heart when the computer system went down. The hospital doctor released her and assured her that if anything were wrong, the radiology department would spot it and she would inform us.

Here it is two weeks later and now they are saying because of the computer problem the entire test didn't get to her cardiologist until today. They think she may have had a minor heart attack and needs further cardiac intervention.

 Is this the new "open and improved" truths we are getting from this hospital? Rideout CEO Robert Chason misinformed us all. 

I am sure my spouse, who has fallen through the cracks during this inexcusable lapse in Rideout's technical policies, is not the only patient suffering similar situations. 

Shame on Chason for minimizing the effects of this catastrophe at our local hospital. 

Edward Ferreira 
Yuba City

Claims that hospital paralysis through health IT outages and malfunctions don't compromise patient care insult my intelligence.  Such claims insult the intelligence of patients and their families, too.  Outages and malfunctions nearly always compromise the quality and safety of care.
  
Patient safety is put at risk because hospitals are not making adequate efforts to keep these systems up 24x7. Many might say they can't afford it.  You don't put in life-critical information systems half-baked, however. Not in medicine, anyway.

Finally, the press, by accepting these Pinocchio-like statements from hospital administrations without severe challenge, only promote cavalier behavior of hospital executives.

Hospital executives:  EHRs are so absolutely essential to patient safety, we spend hundreds of millions of dollars on them. When they crash, however, patient care is never compromised.

-- SS

1:41 PM

Wall Street Journal: "ObamaCare’s Electronic-Records Debacle"

This WSJ Op-Ed could have been entitled "President Sucker:  Led Down the Garden Path by The Healthcare IT Industry."

It is entitled "ObamaCare’s Electronic-Records Debacle", as below.  First, though:

On Feb. 18, 2009 the WSJ published the following Letter to the Editor authored by me (http://www.wsj.com/articles/SB123492035330205101):

Digitizing Medical Records May Help, but It's Complex

Dear WSJ:

You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill.

I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants.

For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors.

HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine.

The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker.

I can only hope patients get something worthwhile for the $20 billion. 

Scot Silverstein, M.D.
Faculty
Biomedical Informatics
Drexel University Institute for Healthcare Informatics
Philadelphia

The UK's National Programme for Health IT in the NHS (NPfIT) has since died. (See my Sept. 22, 2011 post "NPfIT Programme goes PfffT" at http://hcrenewal.blogspot.com/2011/09/npfit-programme-going-pffft.html.)  Also see my Dec. 7, 2008 post "Open Letter to President Barack Obama on Healthcare Information Technology" warning of many issues at http://hcrenewal.blogspot.com/2008/12/open-letter-to-president-barack-obama.html.

Now, the WSJ, to which I and other colleagues have been speaking about the realities of healthcare information technology for years but which has seemed reluctant to publish what would amount to a stinging corporate rebuke, has published this Op-Ed by a surgeon, Jeffrey A. Singer:

http://www.wsj.com/articles/jeffrey-a-singer-obamacares-electronic-records-debacle-1424133213

ObamaCare’s Electronic-Records Debacle
The rule raises health-care costs even as it means doctors see fewer patients while providing worse care.

By Jeffrey A. Singer
Feb. 16, 2015 7:33 p.m. ET

The debate over ObamaCare has obscured another important example of government meddling in medicine. Starting this year, physicians like myself who treat Medicare patients must adopt electronic health records, known as EHRs, which are digital versions of a patient’s paper charts. If doctors do not comply, our reimbursement rates will be cut by 1%, rising to a maximum of 5% by the end of the decade.

I am an unwilling participant in this program. In my experience, EHRs harm patients more than they help.

I note that it's not just physicians who are unwilling participants in this medical experiment.  We all are - as patients - in this unregulated experiment. 

As a colleague puts it, with an addendum by me:

"Why are we implementing patient care tools that are not tested for harms, not evaluated for harms, not reported systematically for harms, while the government does not refute the statement that harms are caused by EHRs and admits the true magnitude of harms is unknown?"

The program was inspired by the record-keeping models used by integrated health systems, especially those of the nonprofit consortium Kaiser Permanente and the Department of Veterans Affairs.

Yet even in those environments, these systems cause major problems, e.g.,

http://www.modernhealthcare.com/article/20140620/NEWS/306209940
Complicated, confusing EHRs pose serious patient safety threats [at VA]

By Sabriya Rice
Posted: June 20, 2014 - 8:15 pm ET

Confusing displays, improperly configured software, upgrade glitches and systems failing to speak to one another—those are just a few electronic health record-related events that put patients in danger, according to a new study.

The more complex an EHR system, the more difficult it may be to trace problems, patient safety experts warn. Hospitals planning to add new software or make updates should be strategic about changes and proactively include ways to monitor events.

“Because EHR-related safety concerns have complex socio-technical origins, institutions with longstanding, as well as recent EHR implementations, should build a robust infrastructure to monitor and learn from them,” concluded the report published Friday in the Journal of the American Medical Informatics Association.

Researchers evaluated 100 closed safety investigations reported between August 2009 and May 2013 to the Informatics Patient Safety Office of the Veterans Health Administration.

Among the findings, 74 events resulted from unsafe technology, such as system failures, computer glitches, false alarms or “hidden dependencies,” a term for what happens when a change in one part of a system inadvertently leads to key changes in another part. Another 25 events involved unsafe use of technology such as an input error or a misinterpretation of a display.

The authors of that study admitted the data was very incomplete due to limitations of error recognition, data collection and diffusion, and other factors.

Back to the WSJ:

The federal government mandated in the 2009 stimulus bill that all medical providers that accept Medicare adopt the records by 2015. Bureaucrats and politicians argued that EHRs would facilitate “evidence-based medicine,” thereby improving the quality of care for patients.

This is the "silver bullet theory of IT-enabled transformation" at work.  Add computers and - Presto!  Better care!  After all, how hard can it be to get to the moon in a hot air balloon? 

The moon is "up" and balloons go "up", therefore, why not? All that's required are the right "processes" -- with which the Acme Hot Air Balloon Co. executives can accomplish anything -- and ignoring those pessimistic scientists, engineers and other experts who speak of vacuum of space and radiation and all those esoteric "gotchas" that are bad for business! (See my 2008 Powerpoint presentation to the IEEE Medical Technology Policy Committee on these issues entitled "To The Moon In A Hot Air Balloon: Why Is Clinical IT Difficult?" at this link.)

But for all the talk of “evidence-based medicine,” the federal government barely bothered to study electronic health records before nationalizing the program. The Department of Health and Human Services initiated a five-year pilot program in 2008 to encourage physicians in 12 cities and states to use electronic health records. One year later, the stimulus required EHRs nationwide. By moving forward without sufficient evidence, lawmakers ignored the possibility that what worked for Kaiser or the VA might not work as well for Dr. Jones.

Not only that, the government and industry are hell-bent on avoiding any meaningful quality regulation (see my April 9, 2014 post "FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html).

Even more critically, they didn't bother to seriously study harms.  Leave that to the independent ECRI Institute, whose findings were alarming (see http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html).  The ECRI Institute has not followed up on this study that I am aware; being recipients of government money, as I understand it, to study the problems may have impaired their independence and softened their tone.)

Which is exactly what is happening today. Electronic health records are contributing to two major problems: lower quality of care and higher costs.

The former is evident in the attention-dividing nature of electronic health records. They force me to physically turn my attention away from patients and toward a computer screen—a shift from individual care to IT compliance. This is more than a mere nuisance; it is an impediment to providing personal medical attention.

As someone who formally entered the field in 1992 via postdoc in Medical Informatics at Yale School of Medicine, I can state emphatically that the whole concept of direct physician data entry was an experiment.  In medical informatics, we were exploring ways to avoid the known detriments of direct physician entry via creative applications of information technology.

That experiment has been a clear failure, at least as diffused into the commercial health IT sector in 2015.  However few in my field are willing to admit this due to, in large part, avoidance of dealing with the unpleasant consequences of that admission.  (One pioneer, Clement McDonald now at NIH, has admitted this.  See my Oct. 29, 2014 post "The tragedy of electronic medical records" (http://hcrenewal.blogspot.com/2014/10/the-tragedy-of-electronic-medical.html.)

Doctors now regularly field patient complaints about this unfortunate reality. The problem is so widespread that the American Medical Association—a prominent supporter of the electronic-health-record program—felt compelled to defend EHRs in a 2013 report [now supplanted - see below - ed.], implying that any negative experiences were the fault of bedside manner rather than the program.

AMA has changed its tone.

I think the author of this Op-Ed may have missed the Jan. 21, 2015 letter to HHS from multiple medical societies or submitted this Op-Ed prior to that date. 

A group of 37 medical societies led by the American Medical Association sent a letter to Health and Human Services last month saying the certification program is headed in the wrong direction, and that today's electronic records systems are cumbersome, decrease efficiency and, most importantly, can present safety problems for patients. 

I covered that Jan. 21, 2015 letter at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html. 

Apparently our poor bedside manner is a national crisis, judging by how my fellow physicians feel about the EHR program. A 2014 survey by the industry group Medical Economics discovered that 67% of doctors are “dissatisfied with [EHR] functionality.” Three of four physicians said electronic health records “do not save them time,” according to Deloitte. Doctors reported spending—or more accurately, wasting—an average of 48 minutes each day dealing with this system.

Nurses are having similar experiences.  I've written previously about substantial problems nurses at Affinity Medical Center, Ohio (http://www.affinitymedicalcenter.com/) and other organizations are having with EHRs, and how hospital executives were ignoring their complaints.  The complaints have been made openly, I believe, in large part due to the protection afforded by nurses' unions.

See for example my July 2013 post "RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals" at http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html (there are links there to still more examples), and my June 2013 post  "Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday" at http://hcrenewal.blogspot.com/2013/06/affinity-rns-call-for-halt-to-flawed.html, along with links therein to other similar situations.

Particularly see my July 2013 post "How's this for patient rights? Affinity Medical Center manager: file a safety complaint, and I'll plaster it to your head!" at http://hcrenewal.blogspot.com/2013/07/hows-this-for-patient-rights-affinity.html, where a judge had to intervene in a situation of apparent employee harassment for complaints about patient safety risks.  Also see my post about an open letter to the Chief Nursing Officer (CNO) dated August 15, 2013, at http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html.

That plays into the issue of higher costs. The Deloitte survey also found that three of four physicians think electronic health records “increase costs.” There are three reasons. First, physicians can no longer see as many patients as they once did. Doctors must then charge higher prices for the fewer patients they see. This is also true for EHRs’ high implementation costs—the second culprit. A November report from the Agency for Healthcare Research and Quality found that the average five-physician primary-care practice would spend $162,000 to implement the system, followed by $85,000 in first-year maintenance costs. Like any business, physicians pass these costs along to their customers—patients.

Then there’s the third cause: Small private practices often find it difficult to pay such sums, so they increasingly turn to hospitals for relief. In recent years, hospitals have purchased swaths of independent and physician-owned practices, which accounted for two-thirds of medical practices a decade ago but only half today. Two studies in the Journal of the American Medical Association and one in Health Affairs published in 2014 found that, in the words of the latter, this “vertical integration” leads to “higher hospital prices and spending.”

I do not enjoy the fact that this occurred to my own personal physicians who are now employees of a hospital against which I am substitute plaintiff for my deceased mother, whose injuries were EHR-related.  See "On EHR Warnings: Sure, The Experts Think You Shouldn't Ride A Bicycle Into The Eye Of A Hurricane, But We Have Our Own Theory" at
http://hcrenewal.blogspot.com/2013/09/on-ehr-warnings-sure-experts-think-you.html, actually penned in 2011.

Proponents of electronic health records nonetheless claim that EHRs decrease record-keeping errors and increase efficiency. My own experience again indicates otherwise and is corroborated by research.

The EHR system assumes that the patient in front of me is the “average patient.” When I’m in the treatment room, I must fill out a template to demonstrate to the federal government that I made “meaningful use” of the system. This rigidity inhibits my ability to tailor my questions and treatment to my patient’s actual medical needs. It promotes tunnel vision in which physicians become so focused on complying with the EHR work sheet that they surrender a degree of critical thinking and medical investigation.

"Critical thinking always, or your patient's dead" - Victor P. Satinsky MD, heart surgery pioneer, Hahenemann Hospital.

Distractions to the doctor-patient interaction are unwelcome and damn well better have a very high payback - which the experiment with health IT is showing is simply not there at the stage of development of this commercial technology in 2015.

Not surprisingly, a recent study in Perspectives in Health Information Management found that electronic health records encourage errors that can “endanger patient safety or decrease the quality of care.” America saw a real-life example during the recent Ebola crisis, when “patient zero” in Dallas, Thomas Eric Duncan, received a delayed diagnosis due in part to problems with EHRs.

That event could have led to catastrophe, but such errors are daily occurrences in hospitals all across the country.  See the many posts on this blog of EHR risks under the index link http://hcrenewal.blogspot.com/search/label/glitch.

Congress has devoted scant attention to this issue, instead focusing on the larger ObamaCare debate. But ending the mandatory electronic-health-record program should be a plank in the Republican Party’s health-care agenda. For all the good intentions of the politicians who passed them, electronic health records have harmed my practice and my patients.

Dr. Singer practices general surgery in Phoenix and is an adjunct scholar at the Cato Institute.

I would change that to "... ending the mandatory electronic-health-record program should be a plank in the government's health-care agenda."

Finally, of the author's adjunct affiliation, it seems bad health IT affects physicians all across the political spectrum.

-- SS

11:33 AM

EHRs and Ebola in the Texas Health Presbyterian Hospital ED: the ED physician finally speaks out

At my Oct. 2, 2014 post "Did Electronic Medical Record-mediated problems contribute to or cause the current Dallas Ebola scare?" (http://hcrenewal.blogspot.com/2014/10/did-electronic-medical-record-mediated.html) I had written:

While I have no evidence as to any role of EHRs in this seemingly strange, cavalier and incomprehensible medical decision to send this man home, resulting in potential exposure of numerous other individuals to Ebola (and I am certainly not in a position to have such evidence), I believe this possibility [that is, an EHR-related information snafu - ed.] needs to be investigated fully.

 
I then did an update:

10/3/2014 Update:

My suspicions were apparently correct.  [The hospital admitted an EHR role - ed.]

Then, the hospital retracted its admission, blur and obfuscation broke loose in the press, and the situation became foggy.  See posts by Roy Poses and myself at query link http://hcrenewal.blogspot.com/search/label/Ebola%20virus, including Dr. Poses' Nov. 24, 2014 post "Public Relations and the Obfuscation of Management Errors - Texas Health Resources Dodges its Ebola Questions" at http://hcrenewal.blogspot.com/2014/11/public-relations-and-obfuscation-of.html.

Finally, the primary clinician involved speaks.  Do read the whole article, as it delves into behind-the-scenes issues:

ER doctor discusses role in Ebola patient’s initial misdiagnosis
By REESE DUNKLIN and STEVE THOMPSON
Dallas Morning News
Dec. 6, 2014
http://www.dallasnews.com/ebola/headlines/20141206-er-doctor-discusses-role-in-ebola-patients-initial-misdiagnosis.ece

... "[ED physician Joseph Howard Meier's] notes in the medical records say he had reviewed the nursing notes. Hospital officials told Congress that the ER physician several times accessed portions of the electronic records where the nurse had recorded Duncan’s arrival from Africa. It wasn’t clear, though, “which information the physician read,” hospital officials told Congress. 

Meier told The News he hadn’t seen the Africa notation in Duncan’s records. The physician said the hospital’s electronic medical records system contained a lot of information, which, like patients, “must also be triaged.” 

Clinicians in an ED have to "triage" information from their records systems, just like patients need to be triaged?  That is a candid and astonishing (to anyone with common sense) admission.

Paper charts never had those problems in my own time working in the ED.

Further, ED charts used to be relatively brief, which is why as a Chief Medical Informatics Officer I recommended document imaging systems only in ED's, to make charts available 24/7/anywhere, and data transcriptionists to capture important data into computers later, not full EHR systems where clinicians enter data which I felt (and still feel) are inappropriate in faced-paced, high-risk settings.

(Put another way, the experiments of direct data entry by busy clinicians, and clinicians attempting to drink information from a tangled cybernetic EHR firehose, are proving a failure.)

... The “travel information was not easily visible in my standard workflow,” he said. “This has now been modified very effectively.”

Modified only after near-catastrophe.  How many other "modifications" (i.e., experimental software changes) will be needed over time in this and other EHRs, I ask?  (Perhaps 10,000 such as here: http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html?)

... The News asked Meier whether knowing Duncan’s travel history would have changed his evaluation. 

“If he told me he came from Liberia, this would have prompted me to contact the CDC and begin an evaluation for Ebola,” Meier said, “but the likelihood would have still been low since Mr. Duncan denied any sick contacts.”

Over the next few hours, Meier ordered tests, along with an IV for saline. He prescribed extra-strength Tylenol, which the nurse gave Duncan at 1:24 a.m. Meier reviewed Duncan’s vital signs. CT scans of Duncan’s head were “unremarkable,” the medical records say, showing no sign of sinusitis.

Doctors typically order CT scans to rule out more serious possibilities, such as a hemorrhage or meningitis. In his responses to The News, Meier said he ordered the CT scan because of Duncan’s headache.

Meier did not say whether the CT scan’s lack of an indication of sinusitis factored into his diagnosis. “Sinusitis is mostly a clinical diagnosis,” he said.

At 3:02 a.m., Duncan’s temperature was 103 degrees, his medical records say. Sixteen minutes later, however, Meier entered a note saying: “Patient is feeling better and comfortable with going home.” Meier told The News he hadn’t seen the higher temperature in Duncan’s chart.

Duncan was discharged at 3:37 a.m. with the diagnosis of sinusitis. His last recorded fever, at 3:32 a.m., was 101.2 degrees. Meier prescribed Duncan the antibiotic Zithromax, 250-milligram tablets, to be taken twice the first day and once daily for four more days.

I note two things:

1.  If an EHR company has hiring practices allegedly such as described via Histalk blog at my Aug. 15, 2010 post "EPIC's outrageous recommendations on healthcare IT project staffing" (http://hcrenewal.blogspot.com/2010/08/epics-outrageous-recommendations-on.html), where rank-novice recent college graduates suddenly become EHR experts afters some transfusion of wisdom at corporate HQ (perhaps via this alien neural interface device that imparts the Knowledge of the Ancients: http://stargate.wikia.com/wiki/Repository_of_knowledge?), then what can one expect?

The Stargate neural interface device that imparts the Knowledge of the Ancients via direct brain download.  Presto - instant EHR expert!

and

2.   I note what I am going to somewhat satirically going to call the "Silverstein EHR principle", that states:

• When bizarre and otherwise inexplicable information-related snafus occur in hospitals, especially in fast-paced, high-risk areas, suspect bad health IT as causative or contributory as #1 in your differential diagnosis (or post-mortem, as the case may be).

-- SS

1:16 AM

What in God's Name is Going on With Healthcare IT at Cambridge University Hospitals?

This story about a  UK hospital that recently "went live"with an American electronic health record/enterprise command-and-control system (EPIC) was not only predictable, but expected considering the sorry state of the health IT industry in terms of clinical leadership and regulation.

(It appears this was a "big bang" rollout, see http://www.ehi.co.uk/news/EHI/8845/cambridge-goes-for-epic-big-bang, an implementation method better suited for warehouses and widget suppliers than major hospitals.)

Addenbrooke’s staff blame blood shortage on new eHospital
By CambridgeNews  |  Posted: November 05, 2014
http://www.cambridge-news.co.uk/Addenbrooke-8217-s-staff-blame-blood-shortage-new/story-24513716-detail/story.html

By Freya Leng

Members of staff at Addenbrooke's [hospital, http://www.cuh.org.uk/addenbrookes-hospital] have voiced their concerns about the new IT system which has been blamed for a blood shortage.

Cambridge University Hospitals' eHospital went live on October 26 and is designed to improve the quality of care for patients by allowing clinicians and frontline staff to access patient information wherever they are, at the click of a button.

I must put to rest this lie once again.  The unregulated, generally terrible software being sold by the so-called EHR vendors is NOT simply software to allow clinicians to  "access patient information wherever they are."  

This is enterprise clinician and clinical resource command-and-control software, through which increasingly each transaction related to care must pass.  In other words, ERP packages to manage patient care, as one might manage inventory and shipping in a merchant enterprise:

http://en.wikipedia.org/wiki/Enterprise_resource_planning

Enterprise resource planning (ERP) is a business management software—usually a suite of integrated applications—that a company can use to collect, store, manage and interpret data from many business activities

Unfortunately, the reductionist assumptions behind the conception, design, authoring and implementation of such ERP software - that hospitals and healthcare are linear, predictable processes - are both deadly wrong, and the beliefs of fools and the recklessly cavalier.

To wit:

But since the launch, the News has been contacted by a senior member of staff at Addenbrooke's who said the new IT system was having "serious consequences" on the "operational running of the service".

In a letter, the staff member who does not want to be named [due to potential for retaliation - ed.], said: "The hospital has very little blood available due to transfusion lab technical failures. Truth - the new IT system is responsible."

The letter also states the impact the shortage of blood has had on the hospital including the cancellation of all elective surgery until November 8 as well as impacting on any procedure that holds a risk of blood transfusion and organ transplantation.

"I believe sufficient risk has been placed upon all patients under care of Addenbrooke's," the staff member said. "Someone needs to be responsible for the implementation of the new IT system."

In my experience, the non-clinical executives who often select this technology, and the IT personnel who then implement the technology (often ignoring clinicians), do need to be held responsible for bad outcomes - in the courtroom.

The News also understands the whole system went down for six hours at the weekend with staff reverting back to paper and all major trauma cases diverted elsewhere.

There are numerous cases on this blog of disruptive and patient-endangering EHR system outages.  These are simply inexcusable regarding life-critical computing. The unexpected transitions back and forth between paper endanger patients.

A doctor, who also did not want to be named, said the wifi system which supports all the ward rounds is "unfit for purpose" and is leading to gross inefficiency.

If this is true, it once again represents the cavalier nature of those technologists rarely held accountable for mistakes that, of they occurred in other critical industries (e.g., aviation, nuclear energy) might leave smoldering ruins and radioactive clouds that would result in the end of their careers...at the very least.  Unfortunately, individual injured and dead patients are not quite as visible to the public.

"The general feeling on the ground is that they could not have implemented the system any worse than they have done and without any doubt it has already significantly affected patient care." they said.

This is consistent with my own personal experience with hospital IT departments in the U.S., where mistakes that I could not even have conceived of making, were regularly made - leaving me to have to point out and clean up the mess, at risk to my own career due to the reactions of the non-clinical IT leaders and staff to being shown their own inadequacy regarding clinical affairs.  (This was, of course, an odd reaction by people who'd never gone to medical school, let alone had doctoral or postdoctoral study, research and development experience in Medical Informatics.)

A CUH spokesman said: "eHospital gives our staff more time with patients at the bedside, many of whom are frail, elderly and have complex conditions.

Right, just those patients who are most vulnerable to IT debacles and the cascading errors that can result.

"However, unlike banks, shops or travel agents, we cannot close our doors or stop our services to the hundreds of thousands of people we treat every year. So it was always going to be a challenge to implement such a massive change.

That is a very poor excuse for IT malpractice.  It makes the reader believe everything possible in due diligence was done, that others' experience was completely paid attention to, etc.  The results give me great doubt about that...

"Pathology was affected early last week, which led to a brief reduction in the number of tests, but we are increasingly operating as normal. We did carry out a successful 're-boot' of the system early on Sunday morning.

There we go once again  the typical bureaucratic spin that "the malfunctions were minor, nothing to see here, move along, patient safety was not compromised"  (a recurrent refrain with its own index term on this blog, see the 25+ posts at http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised) - while at the same time these systems are represented as revolutionizing medicine - except when they malfunction, at which time they have no meaningful effects on care.

"The much bigger challenge we face is that the Trust is incredibly busy and we have limited numbers of beds available, and which need to be kept free for emergency cases. Operations will continue to be rescheduled until the community care for those who no longer need a hospital bed is in place. We do sympathise with the frustration that people feel and apologise for the delay they are experiencing."

In my opinion, patients put at risk, and injured and dead patients need and deserve more than apologies for information technology malpractice.

Especially at Cambridge University, where in my opinion, this whole affair is truly a world-class embarrassment.

-- SS

11:51 AM

Bug in MetaVision ICU system potentially catastrophic - American bad health IT goes Down Under

I have often written in this blog about healthcare IT defects and the lack of quality control regulation and safety testing.   I have indicated that patients have become guinea pigs for software development and testing, and healthcare facilities a software beta testing "proving ground" and defects remediation site.

This should all be occurring in the lab, not on live patients who've never given their consent to the use of these experimental cybernetic "command and control" systems that, in fact, regulate and govern their care in many ways.

Now there's this from Down Under in the journal Pulse*IT:

http://www.pulseitmagazine.com.au/index.php?option=com_content&view=article&id=2127:bug-in-metavision-icu-system-potentially-catastrophic 

Bug in MetaVision ICU system potentially catastrophic
Written by Kate McDonald on 27 October 2014.

A bug in the MetaVision intensive care software package being rolled out in several Brisbane hospitals has been identified as having the potential to seriously harm or even kill patients, several media outlets are reporting.

Fairfax's The Brisbane Times reported that a risk assessment by the Metro North Hospital and Health Service - which covers Brisbane's Prince Charles and Royal Brisbane and Women's (RBWH) hospitals - had found potentially catastrophic problems with prescription errors caused by the system that had a 60 to 90 per cent likelihood of causing a patient death.

MetaVision, from US vendor iMDsoft, is one of the few specialist critical care software packages on the market. It is able to capture information from medical devices and contains a full medical record specific to ICU patients.

This is U.S. software being foisted onto the very sick ICU patients of another country, Australia.

I should note that the author of the article, Kate McDonald, did an article about me in July 2012 and about my - at the time - upcoming presentation to the Health Informatics Society of Australia in health IT trust (article at http://issuu.com/pulseitmagazine/docs/pulseit_july2012/56, writeup of my presentation and link to slides at http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html).

A 60 to 90 percent likelihood of causing a patient death is of great concern, especially in an ICU.  The likelihood of injury is probably in the same ballpark.

Who detected the problems?  The true experts - those with clinical expertise:

... It also contains medications management and decision support, and is able to interface with the complex IV infusion pumps used to administer medications to patients in intensive care.

The ABC [Australian Broadcasting Company] reported that according to the risk assessment report, “monitoring of patient records by pharmacists has revealed several potentially serious prescription errors specifically caused by the system”.

"Large volume prescriptions and high acuity of patients overlayed [sic] with functional risks of the system increases the likelihood of a SAC 1 (serious harm or death) event.

(Where have I seen computer-caused prescription errors with harm potential caused by bad health IT before?  Here, for one:   "Lifespan (Rhode Island): Yet another health IT "glitch" affecting thousands", http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html.)

According to the ABC, the testing of this software was about par for the course in this unregulated health IT industry:

"There is no record of robust regression or functional testing at vendor, Queensland Health corporate or facility level."

Yet the software has been, and is, being rolled out by eager beavers seemingly just jolly at subjecting non-consenting ICU patients to an American experiment:

MetaVision has been rolled out in the ICUs at the Canberra and Calvary hospitals in the ACT, and at the Gold Coast, Prince Charles, Townsville, Rockhampton, Cairns and Logan hospitals in Queensland, where it has been installed for over a year.

It went live at Brisbane's Royal Children's in June, RBWH in September and at Princess Alexandra Hospital (PAH) just last week.

It is live at the Sydney Adventist Hospital and has also been chosen for a statewide roll-out in all ICUs in NSW.

The software company responds:

MDsoft issued a statement late on Monday saying that the problem was unique to the version implemented at Queensland Heath and does not affect any other installations in Australia.

"Late last week, certain clinicians from Queensland Heath highlighted potential risks as a result of prescribing with the MetaVision clinical information system," iMDsoft's director of marketing, Anne Belkin, said.

"iMDsoft is aware of this issue, and has already provided a solution to Queensland Heath. The software fix has been in testing at the site for several weeks and will be implemented in the near future.

First, one wonders why software being rolled out at hospitals in the Australian state of Queensland would be uniquely affected by such a severe bug, while at other sites it has not.  I question if some "new" features are being alpha- or beta-tested there - using Queensland Health ICU patients as unwitting laboratory rats.

Unless that "fix in testing" is being tested completely offline, this suggests patients are being used as literal software debugging test subjects regarding a flaw that could kill them.  The very best interpretation is that clinicians are asked to work around a potentially fatal "bug" in an ICU setting with the very sickest patients while the "fix" for a bug that should not exist in the first place is being remediated.   

"The risks highlighted by the report were originally identified during testing and, with close cooperation between iMDsoft and the clinicians at the Hospital and Health Service sites, a mitigation plan was immediately put into effect.  ... [The Brisbane Times] said the system has been manually over-ridden with medical charts [presumably the electronic charts - ed.] being reviewed daily by ICU specialists.

This suggests workarounds, which can be dangerous themselves ("one should not have to work around that which is not in their way", as I've written.)

A better and more ethical solution, in my opinion, to a potentially fatal bug's "mitigation plan" would be to turn the system off in the interim and revert to paper - as if the system had crashed - until the "bug" is fixed.

The company is then quoted as making this statement:

"The underlying risk is unique to the version implemented at Queensland Heath, and does not exist in any prior or subsequent releases for Australia. MetaVision is used at more than three hundred sites worldwide and is regulated by stringent international standards to ensure patient safety."

"Three hundred sites worldwide" is a very small number.  This suggests this is a very recent - or perhaps unpopular - offering.

The company site offers this:

iMDsoft is audited on a regular basis by international agencies. Our core products have been granted FDA marketing clearance and other accreditations. Our quality management system is certified under ISO 13485, which ensures that every working process is controlled and continuously improved to meet market and customer requirements.

iMDsoft is audited on a regular basis by international agencies. Our core products have been granted FDA marketing clearance and other accreditations. Our quality management system is certified under ISO 13485, which ensures that every working process is controlled and continuously improved to meet market and customer requirements. - See more at: http://www.imd-soft.us/about-us#sthash.RZMu32FN.dpuf

iMDsoft is audited on a regular basis by international agencies. Our core products have been granted FDA marketing clearance and other accreditations. Our quality management system is certified under ISO 13485, which ensures that every working process is controlled and continuously improved to meet market and customer requirements. - See more at: http://www.imd-soft.us/about-us#sthash.RZMu32FN.dpuf

It would be interesting to know what "stringent international standards" are being followed to "ensure patient safety" (ISO 13485, http://www.iso.org/iso/catalogue_detail?csnumber=36786 for medical devices is likely the one being cited), and what testing the FDA performed specifically.

I don't know of such standards for ICU health IT in the U.S., the country of origin of this software, where regulation of health IT is in the discussion stages by the government and FDA, and very unsatisfactorily I might add (see "FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html).

Nor do I know of rigorous ICU clinical EHR software evaluation and testing regulations and procedures anywhere else, for that matter, although would be glad to be informed of some that could be adopted in the U.S.

The expected excuses also appear:

Brent Richards, director of intensive care at the Gold Coast Hospital and then chairman of Queensland's Statewide Intensive Care Clinical Network, told Pulse+IT last year that the system delivered improvements in workflow and safety.

“ICU is incredibly complex and can be quite hard to computerise, because we have a lot of data flow,” Dr Richards said. “You want to capture all of that data including the data from the equipment interfaces, which is transferred minutely in MetaVision.

“Giving drugs is a lot more complex because ICU patients frequently have numerous infusions, and there is frequent real-time management of infusions – titrating medication infusions is normal in ICU – and the system has got to be able to capture it.”

In response, I penned this letter to Kate McDonald.  It speaks for itself:

From: Silverstein,Scot
Sent: Friday, November 07, 2014 9:58 AM
To: Kate McDonald
Subject: Re: Bug in MetaVision ICU system potentially catastrophic

Re:  http://www.pulseitmagazine.com.au/index.php?option=com_content&view=article&id=2127:bug-in-metavision-icu-system-potentially-catastrophic

Dear Kate,

I hope you are well.  My Australian colleagues alerted me to your article on the Metavision ICU flaws.

The excuse that:

... “ICU is incredibly complex and can be quite hard to computerise, because we have a lot of data flow,” Dr Richards said.

rings incredibly hollow.

If an ICU is so complex, the most stringent IT testing is indicated BEFORE go-live on actual patients.  If this were an aircraft or nuclear energy facility, one might now have a smoldering ruin or a Chernobyl (or Three Mile Island in the U.S., http://en.wikipedia.org/wiki/Three_Mile_Island_accident) radiation cloud.

Live patient environments, especially with the sickest in an ICU, are not proper software beta testing and debugging environments.

This is why in the U.S. I call for mandatory and strict quality and safety regulation of healthcare IT that will be employed on patients, much as software is regulated in other mission-critical and life-critical industries.

The health IT industry has for decades been given an extraordinary regulatory accommodation - that is, little to no regulation - and this can, and has, harmed and killed patients.

Please consider this letter suitable for publication.  I addressed some of these issues in my keynote at HISA 2012 in Sydney.

Sincerely,

Scot Silverstein

I, for one, certainly do not want buggy software deployed in ICU's anywhere near my residence.  Hospitals have a legal and ethical obligation to maintain safe environments for care.

Australian as well as American hospital management seem to have been cavalier about that when it comes to healthcare information technology.

-- SS

9:15 AM