ads

,
HomePosts filed under Politico
Showing posts with label Politico. Show all posts
Showing posts with label Politico. Show all posts

Politico 2015: EHR sellers using “gag clauses” (despite Koppel/Kreda's 2009 JAMA article on EHR nondisclosure clauses, and my 2009 JAMA Letter to the Editor on how these clauses violate Joint Commission safety standards)

I have not blogged on EHR issues in some time, despite some interesting source material such as:


These can be read at the links above, and are self-explanatory.

A new Politico investigation and article, however, is worth writing about:
  
Politico
Doctors barred from discussing safety glitches in U.S.-funded software
Darius Tahir
09/11/15
http://www.politico.com/story/2015/09/doctors-barred-from-discussing-safety-glitches-in-us-funded-software-213553

President Barack Obama’s stimulus put taxpayers on the hook for $30 billion in electronic medical records, many of which have turned out to be technological disasters.

But don’t expect to hear about the problems from doctors or hospitals. Most of them are under gag orders not to discuss the specific failings of their systems — even though poor technology in hospitals can have lethal consequences. 

[Change the "can" to "does", e.g., ECRI Deep Dive, http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html - ed.]

A POLITICO investigation found that some of the biggest firms marketing electronic record systems inserted “gag clauses” in their taxpayer-subsidized contracts, effectively forbidding health care providers from talking about glitches that slow their work and potentially jeopardize patients.


[E.g., see http://hcrenewal.blogspot.com/search/label/glitch - ed.]

POLITICO obtained 11 contracts through public record requests from hospitals and health systems in New York City, California, and Florida that use six of the biggest vendors of digital record systems. With one exception, each of the contracts contains a clause protecting potentially large swaths of information from public exposure. This is the first time the existence of the gag clauses has been conclusively documented.

I note this Politico article appears six years after the seminal JAMA article on hold harmless and defects nondisclosure clauses:

as well as:


In that 2009 JAMA Letter to the Editor I observed:

... In their Commentary, Dr Koppel and Mr Kreda made clear the problems associated with applying the customs and traditions of business software contracting and sales (where “hold harmless” and “keep defects secret” clauses are commonplace) to health care information technology (HIT) as if they are the same. I believe that ignoring their differences has likely created an epidemic of violations of hospital governing body responsibilities and Joint Commission standards for health care organization leadership.

In 2015 I stand by these assertions.  Computer and business personnel - through arrogance, selfishness, narrow-mindedness and other issues - have made a mess assuming that business software practices apply to clinical medicine and healthcare IT.  In the latter domain, however, increased clinical stress and hypervigilance due to bugs clinicians have to work around (that might have been fixed sooner), lessening their performance and increasing risk, and patient injury and death has been the result of a belief that clinical computing is just a niche area of business computing.  (I've been making this point for at least 15 years, I might add.)

Such contractual practices endanger patients, and in 2015 are reckless, negligent and inexcusable.

http://injury.findlaw.com/accident-injury-law/recklessness.html
Recklessness means the person knew (or should have known) that his or her action were likely to cause harm. Negligence means that the person acted in violation of a duty to someone else, with the breach of that duty causing harm to someone else.

More from the Politico article:

Vendors say such restrictions target only breaches of intellectual property and are invoked rarely.

IP breaches?  While I understand the business issues at hand, in reality this is farcical.  There is little unique and valuable IP in these systems...as if one EHR vendor would really copy off another EHR vendor's screens.  I've seen many EHRs and their instruction manuals and in my opinion there's little worth stealing from any of these look-alike systems.

But doctors, researchers and members of Congress contend they stifle important discussions, including disclosures that problems exist. In some cases, they say, the software’s faults can have lethal results, misleading doctors and nurses who rely upon it for critical information in life-or-death situations.

Change the "can" to "do."  See ECRI link above, posts such as at http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html, and as readers here know, I have one less living relative thanks to EHR faults.  (I know of others that I cannot discuss.)

Critics say the clauses – which POLITICO documented in contracts with Epic Systems, Cerner, Siemens (now part of Cerner), Allscripts, eClinicalWorks and Meditech – have kept researchers from understanding the scope of the failures.

I actually refute that.  I believe many researchers (in the field of Medical Informatics, at least) were blinded by their own wishful thinking about health IT and their own misplaced overconfidence in computing.  My writings for a decade and that of many other "iconoclasts", based on experience and insight from other fields in which we worked, clearly raising huge red flags, were derided or summarily ignored.  For instance, see my post "The Dangers of Critical Thinking in A Politicized, Irrational Culture" from almost exactly five years ago at http://hcrenewal.blogspot.com/2010/09/dangers-of-critical-thinking-in.html.  There was enough data to ascertain that major problems were extant.

Even the ECRI Deep Dive EHR safety study referenced above, now at least three years old, finding 171 IT mishaps in 9 weeks in just 36 hospitals voluntarily reported, causing 8 significant harms and 3 possible deaths, is rarely cited by the "researchers."  See http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html.

... Sheldon Whitehouse (D-RI) asked a panel of witnesses [during a HELP committee hearing earlier this summer], including Allscripts CEO Paul Black: “Can anyone on this panel see a single reason why these contracts should have gag clauses in them?”  No one ventured a reason.

Perhaps, I ask, because it would be hard to say something like "Senator, our computers have more rights than patients, and we don't give a damn about patient harm as long as the $$$ keep rolling in, and payouts for screw-ups that do make it to court are manageable", Ford Pinto-style, in such a setting?

After POLITICO disclosed its findings, an aide to HELP Chairman Lamar Alexander (R-Tenn.) said the committee would look at the issue, “exploring potentially harmful effects of these clauses – including how they could inhibit interoperability.”

The interoperability issue is a diversion if not a non-sequitur.  Dreamers still believe billions will be magically saved, and lives saved, via "interoperability", ironically at a time when basic operability is poorly achieved.

Let me state this clearly:  health IT will always be a major cost center and will never result in the mass cost savings attributed by the pundits to it.  From experience, I state that is a pipe dream, a fantasy, a risible statement consistent with a mania over the technology.  The issues in medicine that cost dear money are complex, and are not amenable to solution via cybernetic miracles.

See http://hcrenewal.blogspot.com/2012/09/wsj-koppel-and-soumerai-major-glitch.html for more on this issue:

... a comprehensive evaluation of the scientific literature has confirmed what many researchers suspected: The savings claimed by government agencies and vendors of health IT are little more than hype.

To conduct the study, faculty at McMaster University in Hamilton, Ontario, and its programs for assessment of technology in health—and other research centers, including in the U.S.—sifted through almost 36,000 studies of health IT. The studies included information about highly valued computerized alerts—when drugs are prescribed, for instance—to prevent drug interactions and dosage errors. From among those studies the researchers identified 31 that specifically examined the outcomes in light of the technology's cost-savings claims.

With a few isolated exceptions, the preponderance of evidence shows that the systems had not improved health or saved money.


Rather than saving money, the industry is sucking in some of that $17 or so trillion the United States just doesn't have (http://www.usdebtclock.org/).  See for instance "The Machinery Behind Health-Care Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records", Washington Post, by Robert O'Harrow Jr., May 16, 2009.

Back to Politico:

... Take Cerner’s agreement with LA County’s Department of Health Services, signed in November 2012 and worth up to $370 million. It defines the vendor’s confidential information as “source code, prices, trade secrets, mask works, databases, designs and techniques, models, displays and manuals.” Such information can only be revealed with “prior written consent.” The protections cover the provider company, and its employees.

Such agreements, which are typical of the contracts examined by POLITICO, “contain broad protections for intellectual property and related confidentiality and non-disclosure language which can inhibit or discourage reporting of EHR adverse events,” said Elisabeth Belmont, corporate counsel at MaineHealth.

Belmont said she had also seen non-disparagement wordings that prohibit providers from disseminating negative information about the vendor or its software. POLITICO found no direct evidence of such clauses.

"Non-disparagement wording?"

How about good old-fashioned Orwellian thought control?  See my Oct,. 2013 post 'Words that Work: Singing Only Positive - And Often Unsubstantiated - EHR Praise As "Advised" At The University Of Arizona Health Network' at http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html.


... The executive branch—the Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare and Medicaid Services are responsible for the subsidy program— has done little about the clauses, though providers and researchers have been grumbling about them since the 2011 Institute of Medicine report warning that “[t]hese types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks.”

...Agency officials say they deplore the clauses but lack the capacity to directly address the problem. “We strongly oppose ‘gag clauses’ and other practices that prevent providers and other health IT customers and users from freely discussing problems and other aspects of their health IT,” an ONC spokesman said.

But, he continued, ONC cannot police them. The clauses take a variety of forms, and the extent to which vendors invoke them varies, making enforcement difficult – particularly for a small agency that doesn’t have investigative or police powers.

A small agency that doesn’t have investigative or police powers?  Really?  Yet - ONC is a promoter of the non-regulatory "Safety Center" concept as a solution to health IT safety risks.  See for instance http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html.  Their response above to Politico seems disingenuous.

What follows in the Politico article is vendor excuses and soothing reassurances, like this one:

... Epic executives said they encourage open discussion. “With permission, we very frequently allow folks to share information around the software,” said Epic’s vice president for client success, Eric Helsher.

I'll surmise I would not be able to easily get detailed information on the ten thousand EPIC "issues" I highlighted at my Nov. 2013 post "We’ve resolved 6,036 issues and have 3,517 open issues": extolling EPIC EHR Virtues at University of Arizona Health System", http://hcrenewal.blogspot.com/2013/11/weve-resolved-6036-issues-and-have-3517.html, for publication on this blog.

... a lot of problems may go under-reported. That offends [Dr. Bob] Wachter, who says the patient safety world “takes it as religion” that information be shared as widely as possible.

“These are worlds colliding. You can understand why a technology business would put restrictions on screenshots. But we’re not making widgets here, we’re taking care of sick people,” he said.

“At some level, I’d say, ‘How dare they?’”

"At some level?"  What level, exactly?

How about the life-and-death level?

Worlds colliding, indeed; the aforementioned business-IT world and the clinical world.  I would drop the "at some level" phrase, though, and also go back to my 2009 JAMA letter observation that I repeat once again: 

... In their Commentary, Dr Koppel and Mr Kreda made clear the problems associated with applying the customs and traditions of business software contracting and sales (where “hold harmless” and “keep defects secret” clauses are commonplace) to health care information technology (HIT) as if they are the same. I believe that ignoring their differences has likely created an epidemic of violations of hospital governing body responsibilities and Joint Commission standards for health care organization leadership.

Health IT companies are simply not team players in medicine.  Their heavy-handedness and narrow thinking has harmed and killed patients.   How many in total? 

Last year I spoke to a half dozen US House members and a dozen or so aides of House members who could not attend.   I was accompanied by two Plaintiff's lawyers (yes, Plaintiff's lawyers) who told their own tales of EHR-mediated catastrophes whose survivors they had represented.  They were there for that purpose, to inform the US Reps that health IT was killing people.

Extrapolating the ECRI Deep Dive study figures and adding in other known cases, the true level of harms is anything but pretty.

It would be a very useful exercise to measure it explicitly rather than using the Ostrich approach (see for instance my 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). 

However, obtaining the data in a robust matter could result in those reporting the data violating EHR gag and non-disparagement clauses.

We must respect the rights of the computers...

-- SS

Addendum:  the Politico article, unfortunately, while a major piece, did not cite Koppel/Kreda or their pioneering 2009 JAMA article.  I surmise this was an oversight.


11:04 AM

Challenging the meme that [yes, there are all these drastic flaws and problems - BUT] ... EHRs improve patient safety

One of the most persistent memes in healthcare IT is that, for all their deficits, bugs, flaws, interferences in care, and so forth, these systems "improve patient safety."

I find the meme remarkable.

37 medical societies can issue a complaint letter about how EHR systems interfere in care and pose patient risk (http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html).  The Joint Commission can issue a detailed Sentinel Event Alert outlining the myriad ways that these systems "introduce new kinds of risks into an already complex health care environment where both technical and social factors must be considered" (http://www.jointcommission.org/assets/1/18/SEA_54.pdf).

ECRI Institute can, year-after-year, report health IT as among the top ten technology risks in healthcare (2015 list at https://www.ecri.org/press/Pages/ECRI-Institute-Announces-Top-10-Health-Technology-Hazards-for-2015.aspx).

This writer can casually aggregate quite a few examples of EHR flaws, risks and harms without really trying very hard (http://hcrenewal.blogspot.com/search/label/glitch).  Some of these include incidents where EHR flaws could have or did affect thousands, a feat nearly impossible with paper (http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html).

Outages that make all records unavailable can occur with regularity (e.g., http://hcrenewal.blogspot.com/2015/05/another-day-another-ehr-outage-medstar.html).

The ECRI Institute in its "Deep Dive" analysis can gather voluntary reports of 171 IT mishaps in just 9 weeks from 36 hospitals capable of causing harm, with 8 injuries and 3 possible deaths resulting (http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html).

Medical malpractice insurers can reveal an increasing number of medical malpractice cases (and injury) involve EHRs (e.g., http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html, also http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=norcal, also http://www.msms.org/AboutMSMS/News/tabid/178/ID/2595/System-Dangers-How-EHRs-Can-Contribute-to-Medical-Malpractice-Claims.aspx).

Yet, the "BUT" phrase seems to reliably appear in articles about these flaws:

"BUT" EHRs improve safety.

Of course the comparator in such statements is the paper record.

For instance, in the June 11, 2015 Politico report "Why Health Care IT Is Still on Life Support" (http://www.politico.com/magazine/story/2015/06/electronic-medical-records-doctors-118881.html), Arthur Allen sums up the problems very well such as:

  • In surveys, doctors describe the EHR as the biggest cause of job burnout—worse than long hours, billing and other nuisances.  [Burnout is not exactly contributory to patient safety - ed.]
  • One frequent complaint is mental strain.
  • The doctors can’t tell one patient from another in the absence of idiosyncratic impressions. The memorable rash or symptom a patient reported is buried in screen after screen of seemingly trivial data [what I've called "legible gibberish" on this blog - ed.] In an ER or ICU, with time of the essence, this can become a critical safety problem.
  • EHRs are inevitably listed among the 10 top safety concerns for doctors because they introduce new kinds of errors.
  • “All the clicking saps intellectual power and concentration and blocks normal conversation."
  •  “The computerization of medicine will surely be that long-awaited ‘disruptive innovation,’” but “today it’s often just plain disruptive: of the doctor-patient relationship, of clinicians’ professional interactions and work flow, and of the way we measure and try to improve things.”

Yet with all of the above, the following familiar claim is made about these systems:

  • Overall, EHRs are probably improving patient safety—they have replaced illegible medical scrawl with typing, for instance.

At least the word "probably" was used.  Not to single out this article, as the refrain seems commonplace.

I opine in any case that the advantages of occasional handwriting illegibility problem resolved by EHRs are quite thoroughly nullified by critical data being "buried in screen after screen of seemingly trivial data" and other information-clouding issues related to EHR outputs.  See for instance "Two weeks, two reams" at http://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html.

(Missing in this report, like most others on EHR problems such as the May 2015 American College of Physicians report "Frustrations with EHRs rampant as development slows" (http://www.acpinternist.org/archives/2015/05/EHRs.htm) are mentions of patient harm and deaths.  That topic seems verboten.)

In view of all the above, let me state this clearly:

With the increasing amount of knowledge about the flaws of these systems, coupled with the reports of harms in an environment where our top medical organizations and officials admit that the true rate of harms cannot be known due to inadequate reporting infrastructure, policies, and procedures (see http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html), my belief is that these systems in their present form do not improve patient safety.

My belief is that these systems as they are today decrease patient safety, perhaps markedly, over a reasonably-staffed clinician paper records system. 

To take the enthusiast view is to ignore all of the above.  

For instance, extrapolating the ECRI Deep Dive figures alone is alarming, and to date I have not seen any arguments whatsoever as to why those figures should not be extrapolated.

The situation is only to become worse as more and more hospitals without strong internal expertise increase the complexity of the in-house clinical information systems.

The line that "EHRs increase patient safety" in view of all the problems that are now apparent even to the most hyper-enthusiastic EHR pundit is, I believe, wishful thinking run amok.

Such statements defy common sense.

The need for a very robust reporting mandate on EHR-related close calls and actual harms sorely needed.

It is the only way to know for sure whether we've moved from the occasional paper record-related mishap to a more pervasive EHR-confusion related medical misadventure circus.

Unfortunately, I don't see such mandatory reporting taking place any time soon.  A "health IT safety center" without regulatory authority and receiving HIT mishap reports on a 'voluntary' basis is favored by the industry and its government sponsors (see http://hcrenewal.blogspot.com/2014/07/new-onc-director-karen-de-salvo-no.html).  A safety center will quite likely be "safely" ignored by the sellers and users of the systems, when it suits their financial interests (which is nearly always).  It is a band-aid solution to a very serious problem.

It seems apparent to me, considering all these problems, that health IT incentives should stop.  Further, new EHR rollouts need to be put on hold until this technology is more thoroughly vetted.  Until then, harms and deaths of patients are in part the fault of those who knew, should have known, or should have made it their business to know of the risks of bad health IT.

-- SS
11:10 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

Another day, another EHR outage: MEDSTAR EHR goes dark for days

At my March 2, 2015 post "Rideout Hospital, California: CEO Pinocchio on quality of patient care during hospital computer crash" (http://hcrenewal.blogspot.com/2015/03/rideout-hospital-california-ceo.html) I highlighted a stunning example of when the light shone through the corporate B.S. about health IT outages, thanks to a letter to the editor by a family member of an affected patient:

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

I am aware of another major EHR outage via Politico.com:

4/9/15
http://www.politico.com/morningehealth/0415/morningehealth17818.html

MEDSTAR EHR GOES DARK FOR DAYS: MedStar’s outpatient clinics in the D.C. and Baltimore area lost access to their EHRs Monday and Tuesday when the GE Centricity EHR system crashed. The system went offline for scheduled maintenance on Friday and had come back on Monday when it suffered a “severe” malfunction, according to an email from Medstar management that was shared with Morning eHealth.

“All of a sudden the screens lit up with a giant text warning telling us to log off immediately,” a doctor said. “They kept saying it would be back up in an hour, but when I left work Tuesday night it was still down.”

This doctor told us that the outage was “disruptive and liberating at the same time. I wrote prescriptions on a pad for two days instead of clicking 13 times to send an e-script. And I got to talk to my patients much more than I usually do.

But of course we didn’t have access to any notes or medication history, and that was problematic.” MedStar notified clinicians in the email that any information entered in the EHR after Friday was lost.

I do not know if corporate issued the standard "patient safety was not compromised" line, but can almost predict it was uttered somewhere along the line.

MedStar is a big healthcare system.  An outage for several days at its outpatient clinics is disruptive and will lead to harms in the short term, but also in the long term, that cannot be effectively tallied, due to lost information. 

That includes information put on backup paper that fails to get entered when an EHR goes back up, as well as outright computer data loss as occurred here.

Note the doctor's comments about the "liberating" aspect of being freed from health IT.  He/she could actually practice medicine, not computer babysitting.

How many harms will come of this "major malfunction?"  There is no way to know.  However, hospitals cannot have it both ways.  If these systems are touted as improving safety, then safety is affected when they are down and emergency measures are put into place, resulting in chaos; and certainly when information simply goes to the "bit bucket."

The answer?  Either far more redundancy, or far less reliance on "paperless" systems.

There also needs to be mandatory reporting of EHR outages and root cause analysis so the incidence and the reasons can be studied, at the very least.

-- SS
8:59 AM