Wednesday, September 18, 2013

Updates on Three Medical Malpractice Cases Involving EHR's

Scorecard:

Case 1 - dead adult due to failure to intubate when in respiratory distress, causing anoxia and brain death; allegations of EHR alteration; case delayed six months due to newspaper publicity.
Case 2- adult renal failure patient infected with hepatitis C from transplant; lawsuit just filed.
Case 3 - dead baby due to x-ray never being read; hospital filed a Motion to Compel Settlement Conference.

The details:

Case 1:

Trial to begin in wrongful death claim
Monday, September 19, 2011
By Sean D. Hamill, Pittsburgh Post-Gazette

As far as Samuel Sweet was concerned, he only had a headache. It was a bad one, but nothing more, maybe something his chiropractor could fix with a little adjustment.

But three days after being admitted to UPMC Presbyterian for what his family was told was a treatable amount of bleeding on the brain, and six hours after his family saw him laughing and chatting about the Penguins' playoff chances, early in the morning of May 16, 2009, Mr. Sweet died unexpectedly.

Why he died is the subject of a civil case his family filed a few months later that is set to be heard by a jury as early as today in Allegheny County Common Pleas Court. [Read the whole story at link above - ed.]

Set to be heard by a jury as early as today (i.e., Sept. 19, 2011)? Well, no, actually. As a result of this newspaper story, the defendants filed a complaint with the judge, who ordered a six month delay in further proceedings. The complaint and decision is at this link (PDF).

Apparently, sanctions sought by the defendants against the plaintiff's attorney for "leaking" public information to the public about matters affecting their own health and safety were denied.

I find the allegations of EHR alteration of interest:

... [Plaintiff attorney] Ms. Maliver said UPMC's timeline came into question in early August 2011, when UPMC finally turned over -- after two years of discovery [i.e, they turned them over at the last minute, a few weeks before trial was scheduled to begin - ed.] -- 1,200 pages of "results detail sheets" which show not only when something was written in Mr. Sweet's electronic chart, but who wrote it and how.

[They possibly never expected someone to actually go through the 1,200 pages in detail on such a short time frame, but, apparently, the plaintiff's attorney took on the challenge - ed.]


So, for example, Ms. Maliver alleges that the results detail sheets show that during the 21 minutes before Mr. Sweet was said to stop breathing, none of the information in his chart is straight from the computer monitors that would tell what his vital signs were during that period.

But the results detail sheets also show something more troubling, Ms. Maliver said.

She said she found evidence that three days after Mr. Sweet died, Dr. Richard Simmons, UPMC Presbyterian's head of quality assurance, tried to put a "Diff Intub" [difficult to intubate, due to anatomy - ed.] red-letter warning on Mr. Sweet's electronic medical record. That effort showed up on the results details sheets, according to Ms. Maliver.

Such a warning would tell anyone who opened the record that Mr. Sweet was difficult to intubate.

Dr. Simmons wasn't trying to alter the record, [attorney for the defendants] Mr. Conti said
; instead he was in Mr. Sweet's medical record as part of the "peer review" process, assessing what happened in Mr. Sweet's case.

As part of that, he was in the medical record three days after Mr. Sweet died trying to figure out how one would create a warning about a patient's difficult intubation [in effect, altering the record, at the very least through creation of a confusing audit trail - ed.], Mr. Conti said.

Moreover, Mr. Conti said, such a warning was irrelevant because "Dr. Kaura said he understood Mr. Sweet was a difficult airway just by looking at him." [In the picture of the patient in the newspaper article, I cannot tell that; perhaps Dr. Kaura could get a new career as a clairvoyant. In any case, the clairvoyance seemed insufficient for expert help to be called in a timely fashion, i.e., STAT - ed.]

I have problems with this explanation of EHR fiddling, coming from a defense attorney regarding someone who, as head of quality assurance, must have been extremely well-versed in 1) peer review, 2) the code of conduct regarding medical record alteration e.g., in the Pennsylvania Medical Care Availability and Reduction of Error (MCARE) Act of 2002 (PDF, see Section 511, "Preservation and accuracy of medical records", pg. 18-19), and 3) electronic health records systems, metadata, audit trails (and the difficulties in deciphering them), etc.

I suggest several possibilities.

The head of quality assurance was:

  • Merely experimenting with the EHR during Peer Review for his own education, using the chart of a dead man who died under conditions suspicious for malpractice, rather than a dummy chart or test environment created for the purpose;
  • Experimenting with the EHR using the chart of said dead man to educate the staff on how to place the appropriate warning about difficult intubations;
  • Trying to discover if Windows was superior to Mac OS X by comparing to a MacBook Air in his lap;
  • Seeing if he could generate Windows protection faults through aggressive fiddling;
  • Looking for the "Super Mario" game on the computer;
  • Attempting to spoliate crucial medical information that could put the physicians and medical center at risk of liability.

I leave it to the reader to decide which possibilities are most likely.

My comments are that:

  • I feel sorry for the family, who must now endure six more months of suspense and suffering absent their loved one, and
  • I am concerned about public health issues, the public being potentially exposed to six more months of risk that will not be investigated until the case resumes.

Additionally, in an April 2009 post "UPMC as 'Proving Ground' for IT Tests On Children: Pioneers in Health IT, or Pioneers in Ignoring the Past?" I noted that as in a May 2006 article in the Pittsburgh Tribune entitled "UPMC partners with technology provider":

... The University of Pittsburgh Medical Center is taking another step in a quest to commercialize new medical technology.

UPMC on Monday signed a three-year deal with health care information technology provider Cerner Corp. to develop and market medicine-related technological advances. Both parties will contribute $10 million in cash, services and intellectual property to the effort.

The deal is a smaller version of an April 2005 deal between UPMC and information technology behemoth IBM.

As is the case in the IBM deal, UPMC will serve as a built-in proving ground for jointly developed technologies and products, with Cerner marketing the products and UPMC awarded a share of profits.

I wrote, somewhat incredulously:

"Proving ground?"I cannot believe I am reading such a claim. A hospital and patients, as I have written before, are not a learning lab for HIT vendors. The appropriate "proving ground" for new medical technology is the controlled clinical trial where participants (in this case, patients and healthcare professionals alike) have freedom of choice whether or not to participate, and a chance to give (or deny) consent after being fully informed of potential risk.

Were patients or their parents asked to give consent to the use of HIT (such as here)? Were they even aware they were serving as subjects of a "proving ground?" Likewise for clinicians?

... Using a hospital as a "proving ground" for unproven HIT on unconsented or coerced subjects (e.g., children, their parents, and the doctors themselves) [or adults themselves - ed.] probably amounts to battery at the very least, is consistent with violations of fiduciary and Joint Commission safety standards, and I am concerned about it representing human rights violations as well.

In view of the recent Koppel and Kreda paper in JAMA on "hold HIT vendors harmless" and "defects gag" clauses, this entire arrangement seems incredibly disturbing at the very least.I also believe the conflict of interest represented by a healthcare organization partnering with a vendor to "commercialize new medical technology" on unconsented subjects while sharing profits is a horrendous development, for as I stated, the appropriate settings for such practices are properly conducted, impartial clinical trials. The potential for abuses in the current arrangement seems uncomfortably high.

My sentiments seem aligned with IOM's recommendation 4.1 and others on Conflict of Interest as pointed out by fellow HC Renewal blogger Bernard Carroll at this post:


Academic medical centers and other research institutions should establish a policy that individuals generally may not conduct research with human participants if they have a significant financial interest in an existing or potential product or a company that could be affected by the outcome of the research. Exceptions to the policy should be made public and should be permitted only if the conflict of interest committee (a) determines that an individual’s participation is essential for the conduct of the research and (b) establishes an effective mechanism for managing the conflict and protecting the integrity of the research…” (page S-14).

One might reasonably ask if there was a motive to "protect" the health IT when it was suspected of contributing to a patient death. (There was, apparently, the means and opportunity.)

Case 2:


Also from Pittsburgh, and is in followup to my May 2011 postings on a kidney transplant from a hepatitis-C donor entitled "Transplant Team at UPMC Missed Hepatitis Result - Suspicious for Health IT Failure?" and "Healthcare Renewal Cited in Pittsburgh Post Gazette on Health IT Issues."

The affected patients have now sued:

UPMC sued over botched kidney transplant
Tuesday, September 20, 2011
By Sean D. Hamill, Pittsburgh Post-Gazette

A Greene County couple involved in a botched kidney transplant that led to a two-month shutdown of UPMC's living donor kidney and liver transplant programs -- and to state and federal investigations -- filed two malpractice lawsuits this morning in Allegheny County Common Pleas Court.

Christina Mecannic and Michael Yocabet sued UPMC, University of Pittsburgh Physicians, four doctors and one nurse after federal investigators determined that an entire transplant team missed a test result that showed Ms. Mecannic was infected with hepatitis C when her kidney was transplanted into Mr. Yocabet on April 6

A Greene County couple involved in a botched kidney transplant that led to a two-month shutdown of UPMC's living donor kidney and liver transplant programs -- and to state and federal investigations -- filed two malpractice lawsuits this morning in Allegheny County Common Pleas Court.

Christina Mecannic and Michael Yocabet sued UPMC, University of Pittsburgh Physicians, four doctors and one nurse after federal investigators determined that an entire transplant team missed a test result that showed Ms. Mecannic was infected with hepatitis C when her kidney was transplanted into Mr. Yocabet on April 6

The complaints can be retrieved from these links: Yocabet, Mecannic (PDF).

Of interest, there are allegations of intimidation by doctors of the donor once they discovered that the donor was Hep-C positive, with questions about cocaine use, infidelity, etc.

Further, computers are featured relatively prominently in the actual complaint points, e.g., Count 96, emphases mine:

96. Defendant UPP was negligent and showed reckless indifference to Plaintiff in the following particlulars:
  • Creating an environment that jeopardized patient safety;
  • Allowing an environment that jeopardized patient safety;
  • Creating an environment that encouraged volume at the expense of patient safety;
  • Allowing an environment that encouraged volume at the expense of patient safety;
  • In failing to promulgate and/or enforce rules, regulations, procedures and standards to ensure that kidney transplants are only performed with suitable patients;
  • By placing financial gain over the safety of its patients;
  • In failing to provide adequate safeguards to ensure that kidney transplant recipients do not receive kidneys from a donor that is positive for Hepatitis C;
  • In having a medical records system in place that fails to properly alert its transplant team of an unsuitable donor;
  • In having a medical records system in place that fails to properly alert its transplant team of abnormal test results;
  • In failing to ensure that medical personnel are properly trained to recognize patients that are not proper candidates to be kidney donors;
  • In failing to properly supervise their staff that provided care to Plaintiff during his admission; and
  • In failing to assure that staff are properly trained and/or supervised in interpreting test results.

My comment here is that, if the doctors and nurses were compelled to use the electronic medical record system and had no other means of being informed of the hepatitis-C result, they should consider counter-suits against the hospital system and/or vendor for forced use of FDA-unapproved, defective (e.g., mission hostile) medical devices known to cause error and injury.


Case 3:

This is in followup to my report of the death of a premature infant at Abington Memorial Hospital in Pennsylvania, as in my June 2011 post "Babies' deaths spotlight safety risks linked to computerized systems."

The news here is that on Sept. 1, 2011 the hospital filed a "Motion to Compel Settlement" that can be seen at this link (.tif file).

Of interest, a plaintiff's amended complaint still includes issues related to computers, e.g., Count 42:

42. Upon information and belief, the incorrect date on the image caused the xray not to be read by a radiologist on the night the image was taken, and that if the image had been correctly dated February 27, 2010, it would have been reviewed by a radiologist immediately, who would have alerted Defendants that the PICC line was improperly positioned and had to be moved back to a safe position. However, since the film was incorrectly dated February 23, 2010, the film was classified as “old” [i.e., cybernetically, by the PACS system - ed.] and was not put in line for immediate review [in effect, the computer determined the clinicians' work flow - ed.], and was not reviewed in time to prevent injury to Plaintiff’s Decedent.

And count 57:

57. The death of Destinee and the losses directly related to her death, were the direct and proximate result of the negligence and carelessness of Defendant, Lindsay Davison, either individually and/or by and through her respective agents, and/or servants, and/or employees, and/or ostensible agents acting through and within the course and scope of their employment, consisting of, but not limited to one or more of the following;

a. failing to obtain an x-ray image of sufficient quality to adequately confirm that the PICC line was safely and properly inserted;
b. failing to recognize that the x-ray image referred to above was of an inferior quality such that it could not be used to confirm that the PICC line was safely and properly inserted;
c. failing to properly associate the correct identifying information about the patient with the x-ray that was taken to confirm the proper placement of the PICC line;
d. failing to put the right date on the x-ray that was taken to confirm the proper placement of the PICC line;
e. causing the x-ray of February 27, 2010 to be mislabeled and/or misdated and/or to not be read in a timely fashion [apparently due in part to computer decision-making about "old" films - ed.]; and
f. failure to prevent harm to Destinee and causing her death.
And:

Count 65, part o: "failing to have in place and enforce policies and procedures in the use of x-ray information and data systems."

I am surprised there is no component of the lawsuit against the PACS vendor for selling defective products.

As I mentioned previously, a computer programmed to consider an "old" but unread x-ray as unimportant (instead of critical to read, due to the effects it might have on the interpretation of later films) and that did not trigger an alarm to wake the dead (no pun intended) is, on first principles, defective.

My overall comment is that these lawsuits demonstrate hospitals had better get their acts together regarding clinical information technology, fast, or they will find their ROI's on the equipment turning sharply and ominously negative.

-- SS

5 comments:

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InformaticsMD said...

Anonymous September 20, 2011 9:49:00 PM EDT writes:

Deceptive Advertising

I keep trying to explain to my mother (via a megaphone to penetrate the two meters of dirt and rock, the concrete crate, and the wooden coffin in the crate) that the health IT vendors all have good intentions, so should be excused as they conduct their human subjects research.

To date, mom has not responded.

-- SS

Anonymous said...

The hepatitis case is that of a defective and poorly usable EMR causing life changing errors.

I like the comment in the article by the hospital blaming human error, "We sincerely regret the human error that caused...".

Clearly, the hospital is protecting its (undisclosed) investment in the EMR and vendor, while blaming 6 of its professionals. The whole transplant team missed this?

No way would this have happened before this EMR was turned on.

No patient is safe with an EMR that enables life changing errors. First the dead man in the ICU, and now, EMR facilitated spread of hepatitis. There have been other deaths that should not have happened when they did, eg the death by frost on the roof of UPMC Montefiore.

If you are hospitalized there, better have an advocate watching 24/7, reviewing all tests and medications, while demanding attention from the nurses who usually have their faces glued to the EMR screens.

Afraid said...

I wish the people who know the truth would start telling it. A group with the goods on the administration at these places could change things.

I wonder why they don't? If there are good people at crooked hospitals, please do something. Otherwise the silence implies compliticy.

InformaticsMD said...

Afraid September 21, 2011 10:50:00 PM EDT writes:

Otherwise the silence implies compliticy.

Correction - it shows fear.

I can write freely, because I gave up medical practice years ago to devote myself full-time to Medical Informatics.

-- SS