Tuesday, September 20, 2011

Updates on Three Medical Malpractice Cases Involving EHR's

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Scorecard:

Case 1 - dead adult; 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; 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.

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 -- 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.

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 - ed.]


I have problems with this explanation, coming from a defense attorney regarding someone who, as head of quality assurance, must have been extremely well-versed in peer review, the code of conduct regarding medical record alteration e.g., in the Pennsylvania Medical Care and Reduction of Error (MCARE) Act of 2002 (PDF), and electronic health records. 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 only 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
  • The public, that is potentially exposed to six more months of risk that will not be investigated until the case resumes.
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 intimation 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 the hospital has 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 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 [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."

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

-- SS

scotsilv@aol.com (InformaticsMD) 21 Sep, 2011


--
Source: http://hcrenewal.blogspot.com/2011/09/updates-on-three-medical-malpractice.html
~
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Scorecard:

Case 1 - dead adult; 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; 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.

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 -- 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.

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 - ed.]


I have problems with this explanation, coming from a defense attorney regarding someone who, as head of quality assurance, must have been extremely well-versed in peer review, the code of conduct regarding medical record alteration e.g., in the Pennsylvania Medical Care and Reduction of Error (MCARE) Act of 2002 (PDF), and electronic health records. 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 only 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
  • The public, that is potentially exposed to six more months of risk that will not be investigated until the case resumes.
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 intimation 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 the hospital has 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 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 [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."

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

-- SS

scotsilv@aol.com (InformaticsMD) 21 Sep, 2011


--
Source: http://hcrenewal.blogspot.com/2011/09/updates-on-three-medical-malpractice.html
~
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