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 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."

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

AMA News Article Offers Incomplete (and Thus Misleading) Advice on the Legal Risks of EHRs and other Clinical IT

An article was published in the AMA News by Alicia Gallegos, AMA Medical News staff, entitled "Legal risks of Going Paperless." While it is not clear if these are the official views of the AMA leadership, the article is interesting nonetheless.

It should perhaps have been entitled "Some of the Legal Risks of Going Paperless, excluding the ones that make the health IT industry look bad:"

Legal Risks of Going Paperless
AMA News
March 5, 2012

Electronic medical records are meant to save time and money, but they also can create liability issues for doctors.

By Alicia Gallegos, amednews staff.

Defense attorney Catherine J. Flynn knows how electronic medical records can overwhelm — and often change — the course of a medical liability lawsuit.

In one of her cases, a New Jersey doctor being sued for medical negligence has been accused by a plaintiff’s attorney of modifying a patient’s electronic history. A printing glitch caused the problem, Flynn said, but the accusation has meant extra time and defense costs. Computer screen shots were reviewed, more evidence was gathered and additional arguments were made.

“This has taken a life of its own, and we’ve done virtually no discovery on the medical aspects of the case,” she said. “The cost of the e-discovery alone is in excess of $50,000.”

This is a variation on the theme of plaintiff's lawyers being the cause of EHR problems as I wrote at "Plaintiff's Trial Lawyers Are to Blame for EHRs That 'Tattle' on Doctors - And Harm Patients."

System breaches. Modification allegations. E-discovery demands. These issues are becoming common courtroom themes as physicians transition from paper to EMRs, legal experts say. Not only are EMRs becoming part of medical negligence lawsuits, they are creating additional liability.

Missing is the problem that is most important of all: health IT system defects, poor user interfaces, unreliability, data loss, etc. causing or contributing to medical malpractice that results in patient harm or death. (An example that I personally observed and reported to the FDA MAUDE database is here; there are numerous others in this blog.)

Data breaches are among the most common reasons that electronically stored information lands doctors in court, said Lisa Gallagher, senior director for privacy and security at the Health Information and Management Systems Society, which advocates health information technology

Most common perhaps (a big problem unto itself), but not the most clinically significant problem. Yet the AMA article goes on about this issue for many paragraphs; it's the prime focus of the article.

A 2011 ruling in New York highlights how e-discovery creates a burden for doctors.

During a lawsuit against St. Luke’s Hospital Roosevelt Center, a debate arose about whether the plaintiff should be allowed access to screen shots from a doctor’s computer. Joan Bowman, who sued the hospital for wrongful death on behalf of her husband, wanted to see a computer template used to aid physicians in diagnoses. The hospital said the request was overly broad and oppressive.

But the Supreme Court of the State of New York ordered the release of the screen shots.

“Defendant doctors testified that they utilized these materials in coming to their diagnosis,” Judge Alice Schlesinger wrote. “It is not a stretch to allow counsel to see and understand these materials.”

At this article’s deadline, the hospital’s attorney had not returned messages seeking comment.

The case sets a precedent, said Susan Dennehy, Bowman’s attorney.

“If others want to see screen shots from records, I think they’ll rely on this case,” she said. “It was important to see where the template led you if you put in an inaccurate chief complaint.”

Note the "spin" about the "burden for doctors" of eDiscovery. To the pundits and voluntary adopters: you have gotten what you asked for. To the non-pundit clinicians forced to use health IT: I hate to say this, but you've gotten screwed.

The article then offers a laundry list of how to avoid EHR-related liability:

... As the number of electronic medical records increases, so do certain legal risks, medical liability experts say. Common mistakes doctors make with EMRs and how attorneys recommend that physicians reduce their liability risks:

Mistake: EMRs allow users to move quickly through patient records, but cutting and pasting information makes it easy to paste incorrect information.
Recommendation: Refrain from copying and pasting EMR data, and be cautious when moving from one patient’s record to the next.

Mistake: Computer programs can help doctors make a differential diagnosis, but the templates don’t often include every possible symptom and corresponding medical condition.
Recommendation: Doctors should not become overly dependent on electronic diagnosis aids. Electronic systems are no substitute for hands-on diagnosis.

Mistake: Because EMRs allow physicians to move through patient charts much more quickly than paper charts, attorneys are noticing that some doctors are not being thorough when writing notes electronically.
Recommendation: Physicians should keep meticulous electronic notes on each patient and take time to document each chart.

Mistake: Some practices can fail to safeguard electronic patient data.
Recommendation: Practices should encrypt all information on computer devices and have policy that discourages employees from taking portable devices out of the office.

Mistake: A system may not clearly indicate changes to records.
Recommendation: Physicians should install systems that show transparency when modifications are made and/or have a program lockout period where no more modifications can be made to a record.

Mistake: Doctors may fail to follow notification requirements in the event of a data breach.
Recommendation: Be clear on what your state law requires when a data breach occurs, and make sure employees follow the rules immediately.

Mistake: Doctors may destroy or delete electronic records when a lawsuit is possible.
Recommendation: If doctors suspect they are being sued, they must preserve all electronic data related to the patient in question, including emails, phone messages and computer records.

Missing is this, as is well-covered by almost 8 years of posts on this blog, and elsewhere:

Big mistake: Doctors and hospitals buy and implement experimental technology approved by nobody, of uncertain quality to the point of losing or corrupting data, often with glass-tube black-and-white TV user interface modernity. Such technology is "errorgenic", i.e., it promotes "use error", can mislead, and can promote medical errors.
Recommendation: Hold off until the industry has gotten its act together.

Also missing from the AMA News article is the fact that physicians and hospitals use health IT at their own risk, even if the IT is "certified."

This article is clearly pregnant with omissions and spin that reveal a pro-health IT bias.

-- SS

Is ONC Stonewalling on the issue of HIT Certification, Safety and Liability?

At my Feb. 16, 2012 post "Hospitals and Doctors Use Health IT at Their Own Risk - Even if Certified" I wrote that an ONC-ATCB (Authorized Testing and Certification Body) replied to my email inquiry about health IT certification, safety and liability indemnification by stating that:

What was suggested in the email below (freedom from liability for users of the system, etc.) would be out of scope for ONC-ATCB testing based on the given criteria.

[That is, the criteria used in testing here - ed.]

What I did not include in that post was the fact that some months ago, I had emailed ONC directly with the same questions, and then called them on the phone with those questions at about the same time as I inquired of the ATCB.

ONC itself never responded.

There are several possibilities:

• They don't know the answer.
• They don't want to respond.
• They don't care to respond.

Dismissing possibility #1, these civil servants appear to be stonewalling on the issue.

It would be nice to hear ONC itself admit the term "certification" is a gossamer guarantee of health IT safety, efficacy and indemnification of purchasers, implementers and users from potential EHR-related liability.

I am not holding my breath.

-- SS

Addendum:

An ONC representative did get back to me on Feb. 27, but I told them my question had already been answered by ONC ATCB's.

Hospitals and Doctors Use Health IT at Their Own Risk - Even if "Certified"

Due to my observations of confusion about health IT certification [1], and due to vague or incomplete seller language that could be misinterpreted by buyers (perhaps by design), I recently asked several ONC-ATCBs (HHS's Office of the National Coordinator for Health IT-Authorized Testing and Certification Bodies) the following.

I sent this question via email to their "questions" email addresses:

"Is EHR certification by an ATCB a certification of EHR safety, effectiveness, and a legal indemnification, i.e., certifying freedom from liability for EHR use of clinical users or organizations? Or does it signify less than that?"

One ONC-ATCB provided the following in response to my request for information.

From: Trivedi, Amit V (ICSA Labs)
Sent: Thursday, February 16, 2012 11:22 AM
To: Scot Silverstein
Subject: RE: Form submission from: Contact Us

Hello Scot,

Thanks for your email. Certification by an ATCB signifies that the product or system tested has the capabilities to meet specific criteria published by NIST and approved by the Office of the National Coordinator. In this case the criteria are designed to support providers and hospitals achieve "Meaningful Use." A subset of the criteria deal with the security and patient privacy capabilities of the system.

Here is a list of the specific criteria involved in our testing:
http://healthcare.nist.gov/use_testing/effective_requirements.html

In a nutshell, ONC-ATCB Certification deals with testing the capabilities of a system, some of them relate to patient safety, privacy and security functions (audit logging, encryption, emergency access, etc.).

What was suggested in the email below (freedom from liability for users of the system, etc.) would be out of scope for ONC-ATCB testing based on the given criteria. [I.e., certification criteria - ed.] I hope that helps to answer your question.

Thanks,

Amit

Amit Trivedi
Program Manager - Healthcare
ICSA Labs, an Independent Division of Verizon Business

Mar. 5, 2012 Addendum:  I also received a response from another ONC-ATCB, the Drummond Group:

From: Joani Hughes (Drummond Group)
Sent: Monday, March 05, 2012 1:06 PM
To: Scot Silverstein
Subject: RE: EHR certification question

Per our testing team:

It is less than that. It does not address indemnification although a certification could be used as a conditional part of some other form of indemnification function, such as a waiver or TOA, but that is ultimately out of the scope of the certification itself. Certification in this sense is an assurance that the EHR functions in way that could enable an eligible provider or eligible hospital to meet the CMS requirements of Meaningful Use Stage 1. Or to restate it more directly, CMS is expecting eligible providers or eligible hospitals to use their EHR in “meaningful way” quantified by various quantitative measure metrics and eligible providers or eligible hospitals can only be assured they can do this if they obtain a certified EHR technology.

Please let me know if you have any questions.

Thank you,
Joani.

Joani Hughes
Client Services Coordinator
Drummond Group Inc.

These are direct and clear statements.

My question was certainly answered. ONC cerification is not a safety validation, such as in a document from NASA on aerospace software safety certification, "Certification Processes for Safety-Critical and Mission-Critical Aerospace Software" (PDF) which specifies at pg. 6-7:

In order to meet most regulatory guidelines, developers must build a safety case as a means of documenting the safety justification of a system. The safety case is a record of all safety activities associated with a system throughout its life. Items contained in a safety case include the following:

• Description of the system/software
• Evidence of competence of personnel involved in development of safety-critical software and any
safety activity
• Specification of safety requirements
• Results of hazard and risk analysis
• Details of risk reduction techniques employed
• Results of design analysis showing that the system design meets all required safety targets
• Verification and validation strategy
• Results of all verification and validation activities
• Records of safety reviews
• Records of any incidents which occur throughout the life of the system
• Records of all changes to the system and justification of its continued safety

Health IT testing conspicuously lacks attention to most of the aerospace software safety points above. I note that there appears to be no reasonable excuse for such omissions.

IOM has recently studied the issue of HIT safety. IOM states in a Nov. 2011 report that HIT safety and safety testing is unsatisfactory, and has recommended HHS study it as well. IOM recommends HHS annually re-evaluate whether regulation is needed to improve safety, although IOM favors industry self-policing [2].

Thus, buyers and users of even "ONC certified" health IT are not indemnified from liability due to medical errors or problems caused by the health IT.

Sellers who exaggerate the value of certification or imply its meaning is akin to FDA device approval, likewise, could be faulted for making false representations about their products.

It would appear the sellers could potentially be sued for doing so by purchasers/users who themselves get into legal hot water due to EHR defects or other problems.

-- SS

Note:

[1] I believe confusion about EHR "certification" is in part due to the term itself. I raised objections to this term when it was first proposed based on my experience in pharma, suggesting what I felt was the more accurate expression "features qualification" instead.

[2] "Health IT and Patient Safety: Building Safer Systems for Better Care", Institute of Medicine of the National Academies, Nov. 2011, http://www.iom.edu/Reports/2011/Health-IT-and-Patient-Safety-Building-Safer-Systems-for-Better-Care.aspx

Those Goddamn Plaintiff's Trial Lawyers Are to Blame for EHRs That 'Tattle' on Doctors - And Harm Patients

It seems the EHR technophiles are starting to notice one of the side effects of EHR technology: the liabilities EHRs impose on users.

Interestingly, those liabilities are presented below as the fault not of a cavalier industry receiving extraordinary governmental and regulatory accommodation compared to other healthcare sectors that, among other issues, have allowed it to (see hyperlinks for more information):

• Disregard practices of good software engineering, product safety and human factors issues (usability),
  
• Ignore tenets of good information presentation yielding literal reams of 'legible gibberish' masquerading as medical records that confuse attorneys on both sides of the Bar as well as clinicians,
  
• Flout proper conduct of human subjects experimentation e.g. without informed consent,
• Avoid appropriate methodologies for medical device trials (all the while promoting the data these devices generate as 'revolutionizing healthcare'),
• and more as covered on this site and at my Drexel University educational site at this link.
  

Instead, the liabilities are presented as the fault of plaintiff trial lawyers, who need to be disempowered through yet another special accommodation for health IT.

My comments are interspersed in [red italics]:

Feb. 8, 2012
The Wall Street Journal
MarketWatch
Healthcare IT Expert Exposes Hidden Risks of Lawsuits Due to Electronic Health Record

Spokesperson Says Electronic Health Records May Give Crippling Access to Physician's Actions and Increase the Need for Defensive Medicine

[Crippling access to physician's actions? That is an odd combination of terms - ed.]

DELRAY BEACH, Fla., Feb 8, 2012 (GlobeNewswire via COMTEX) -- Since the American Recovery and Reinvestment Act (ARRA) passed in February 2009 and caused a digital tsunami in the healthcare industry, physicians have been scrambling to comply with the requirement to switch to electronic health record systems. (EHRs) While many in the healthcare industry laud the use of EHRs to improve quality of care and analyzing patient outcomes, Dr. Sam Bierstock, founder of Champions In Healthcare, points out significant concerns regarding increased vulnerability to medical legal claims that may result from the use of EHRs without major tort reform that would relieve physicians of an onslaught of malpractice suits.

"EHRs unquestionably have the potential to improve patient safety and the quality of care delivered, but what few people realize is that using an EHR exposes physicians to an Orwellian level of analysis of every single act while doing their job," said Bierstock, who has advocated and pioneered the use and benefits of EHRs for more than 30 years." EHRs, however, can also be audited to examine how long it took them to act after an abnormal lab result came in, if the doctor checked on on-line references before making a clinical decision, what was said in every email and how long the doctor took to respond, and even how long the doctor looked at a screen or scrolled down to read an entire document.

[Why, exactly, this is a bad thing, I do not understand; it seems hypocritical. After all, any data collected that can help improve healthcare has been deemed golden - up to now - ed.]

Physicians are exposing themselves to an unacceptable level of scrutiny and analysis of their use of computers that may serve to encourage malpractice suits.

["Unacceptable level of scrutiny" is largely a code phrase for audit trails and other 'metadata', i.e., automatically generated computer data that shows who accessed or modified a document or other data, when, from where, etc. I ask - access to this data is unacceptable to whom? Injured patients? - ed.]

Meaningful tort reform is essential to getting the maximal benefit from these wonderful systems.

[Wonderful systems, when even the IOM admits we don't know the level of harm they cause, the NIST indicates they are poorly usable, and so forth as here? - ed.]

According to Bierstock, the problem runs even deeper because during his career as an industry consultant with Champions in Healthcare, and as a speaker at healthcare events he has noticed that the vast majority of physicians are still not aware of the complex requirements imposed upon them by the Health Information Technology for Economic and Clinical Health (HITECH) Act even though it has been a law for more than two years.

[I agree with the statement "imposed upon them", but this imposition was largely at the hands of the HIT pundits, the 'Ddulites' (technophiles who ignore technology's downsides, the opposite of 'Luddites', link), and various species of non-medical profiteers - ed.]

"I talk to many physicians who have no idea they can suffer financial, civil and even criminal penalties (i.e. jail) for non-compliance.," said Bierstock. "I have been asked to speak about this topic many times, but beyond HITECH, it's my opinion that similarly, doctors and hospitals don't yet fully realize their medical legal vulnerability associated with the use of EHRs.

[They will learn, fast, with Medical Informatics specialists such as myself on patients' side instead of on the side of the health IT industry - ed.]

This will be the case until there is major tort reform, which has unfortunately been thwarted by the influence of American Trial Attorneys and their associations."

[You see, it's all the fault of the evil Plaintiff's Bar - ed.]

Bierstock noted that in an effort to stimulate physicians and hospitals to install and use EHRs, The American Reinvestment and Recovery Act of 2009 also authorized the Centers for Medicare and Medicaid Services (CMS) to issue guidelines which define what is "Meaningful Use" of an EHR - guidelines which must be met in order for hospitals and doctors to receive financial incentive payments for using EHRs, or be penalized by having Medicare or Medicaid payments reduced for failure to meet the guidelines.

[Unfortunately, they did not formulate guidelines for safety. Thus, as Sharona Hoffman, JD notes in MEANINGFUL USE AND CERTIFICATION OF HEALTH INFORMATION TECHNOLOGY: WHAT ABOUT SAFETY?, "General system safety is a property that is attainable only through rigorous processes for development and evaluation. However, the regulations do not address certification of EHR vendors’ software development processes or even require vendors to analyze and mitigate potential safety hazards. Furthermore, ATCBs will use testing requirements developed by the National Institute of Standards and Technology (NIST) that are apparently intended only to determine whether systems include certain features. Passing such tests is not sufficient to ensure that those features function properly in the long term and under varied operating conditions." - ed.]

Bierstock believes that if physicians are expected to embrace EHRS, they should be allowed to do so in a manner that maximizes the benefits of these systems to the delivery of care and to the benefit of their patients without worrying about giving unlimited ammunition to trial lawyers.

[Perhaps the EHR pundits should have foreseen this eventuality before pushing the current administration to mandate national EHR rollout. It didn't take a rocket scientist to do so - ed.]

"Quite simply, physicians may be in a situation that leaves them vulnerable to litigation and threatens loss of their professional standing and personal assets -- all because an external evaluator [e.g., a trial lawyer, judge or jury -ed.] may not think the physician lived up to arguable standards in the digital age," said Bierstock. "Overall, EHRs are the litigator's proverbial golden goose. They are to malpractice attorneys what the electron microscope is to microbiology."

[In other words, EHRs deserve yet another special accommodation, this time regarding legal Discovery, in addition to the many other special accommodations this industry has received. In fact, EHRs make available only that which they are designed to, and discoverability of that information is a Federal matter under the Federal Rules of Civil Procedure (FRCP) governing e-discovery - "On December 1, 2006 the Federal Rules of Civil Procedure were revised to address numerous e-discovery issues. Rules 16,26,33,34,37 and 45 require attorneys to pay specific attention to electronic discovery issues. E-Discovery practices and strategies need to be reviewed and aligned with the updated rules to ensure compliance." - ed.]

I find requests for additional special accommodations for EHR's over other medical devices and IT in other industries (e.g., airplane black boxes and cockpit recorders that monitor the every move of pilots) to be illustrative of the concept "be careful, you may get what you wish for."

That plaintiff trial lawyers are blamed for quite properly using the Federal Rules of Civil Procedure to assure justice for victims of medical malpractice, including EHR-related medical malpractice, is outrageous.

It seems the pundits might be starting to panic, after realizing the "data utopia" that is going to "revolutionize medicine" has a downside.

-- S. Silverstein, MD

Feb. 14, 2012 Addendum:

It seems the clinical data itself generated by today's health IT - garnered while putting patients at risk and costing many billions of dollars - might not be anywhere near as trustworthy as advertised by the technophiles.

See "It Seems We Are Not The Only Ones Bumping Up Against EHR Data Quality Issues. PCEHR Implications Are Worth Considering" at the Australian Health Information Technology blog by Dr. David More, MB PhD FACHI, and the JAMIA articles he references.

Dr. More observes:

... If ever there was an example of “garbage in, garbage out” in operation this has to be it. There has to be a great deal of care taken as we move from the most simplest data sharing to more complex efforts.

-- SS

Making a Stat Less Significant: Common Sense on "Side Effects" Lacking in Healthcare IT Sector

At my Mar. 27, 2011 post "Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost - Supreme Court-Style" I wrote that the SCOTUS decided in MATRIXX INITIATIVES, INC., ET AL. v. SIRACUSANO ET AL. (link to PDF) that:

... We conclude that the materiality of adverse event reports cannot be reduced to a bright-line rule ... Because adverse reports can take many forms, assessing their materiality is a fact-specific inquiry, requiring consideration of their source, content, and context.

Wall Street Journal author and "Numbers Guy" Carl Bialik adds to that point in an article today "Making a Stat Less Significant" where he writes:

To determine whether a medical side effect is significant in an experiment requires knowing that every incidence of that side effect is being reported. Researchers can feel confident that is happening in a controlled clinical trial of a drug, but they can't be sure when a drug is being sold to the general public, as was the case with Zicam.

In other words, when one is not sure that every incident of a side effect is being reported, one should not cavalierly dismiss "anecdotal" reports of side effects, especially from reliable reporters.

The practictioners of Medical Informatics, along with the HIT Industry and its customers, appear to have failed in that regard with respect to clinical IT (electronic medical records, CPOE etc.) For years they have argued that these medical devices should not be regulated because that would "stifle innovation" and that reports of device adverse events were "anecdotal." Many in the field still make these arguments.

This view extends all the way up to the Director of the Office of the National Coordinator for Health IT, who glibly stated per the Aug. 2010 Huffington Post Investigative Fund article FDA, Obama Digital Medical Records Team at Odds over Safety Oversight that FDA's own reports of health IT related injuries and deaths were “anecdotal":

ONC director Blumenthal, the point man for the administration, has called the FDA’s injury findings “anecdotal and fragmentary.” He told the Investigative Fund that he believed nothing in the report indicated a need for regulation.

Those "injury findings" appear in an FDA Internal Memo made available by the aforementioned Huffington Post Investigative Fund and archived at the following link:

Internal FDA memorandum on HIT risks (PDF) to Jeffrey Shuren MD JD (Director, Center for Devices and Radiological Health). Health Information Technology (H-IT) Safety Issues. "This is an Internal Document Not Intended for Public Use." Feb. 23, 2010.

(My description/summary of the memorandum is at my Aug. 2010 post "Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun?")

That memorandum itself emphasizes how FDA's own knowledge of these events is partial due to reporting impediments and lack of knowledge of resources such as FDA's MAUDE database.

The known reports were likely "the tip of the iceberg" according to the Director of FDA’s Center for Devices and Radiological Health (CDRH) Jeffrey Shuren, MD, who also happens to be a lawyer.

As at the aforementioned "tip of the iceberg" link, at an HHS meeting of the HIT Policy Committee's Adoption/Certification Workgroup on February 25, 2010, Shuren testified:

... In the past two years, we have received 260 reports of HIT-related malfunctions with the potential for patient harm – including 44 reported injuries and 6 reported deaths. Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist.

Even within this limited sample, several serious safety concerns have come to light. The reported adverse events have largely fallen into four major categories: (1) errors of commission, such as accessing the wrong patient’s record or overwriting one patient’s information with another’s; (2) errors of omission or transmission, such as the loss or corruption of vital patient data; (3) errors in data analysis, including medication dosing errors of several orders of magnitude; and (4) incompatibility between multi-vendor software applications and systems, which can lead to any of the above.

The problem with ignoring testimony and reports of health IT-related difficulties and dismissing them as "anecdotal" goes back to the issue of "knowing that every incidence of that side effect is being reported."

While FDA itself admits significant doubt about completeness of reporting in its memo, what's worse is that Koppel and Kreda at University of Pennsylvania wrote a paper from which one might conclude that the healthcare and health IT industries are themselves aligned to conceal health IT adverse events reports.

In their remarkable article Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians, Journal of the American Medical Association, 2009;301(12):1276-1278, we learn that there is little motivation for device safety in the health IT industry:

Healthcare information technology (HIT) vendors enjoy a contractual and legal structure that renders them virtually liability-free—“held harmless” is the term-of-art—even when their proprietary products may be implicated in adverse events involving patients. This contractual and legal device shifts liability and remedial burdens to physicians, nurses, hospitals, and clinics, even when these HIT users are strictly following vendor instructions...HIT vendors are not responsible for errors their systems introduce in patient treatment because physicians, nurses, pharmacists, and healthcare technicians should be able to identify—and correct—any errors generated by software faults. [In other words, they are expected to be clairvoyant when presented with erroneous or missing data - ed.]

We additionally learn that:

The significant disparity between buyers and sellers in knowledge and resources [about healthcare IT problems] is profound and consequential. Vendors retain company confidential knowledge about designs, faults, software-operations, and glitches. Their counsel have crafted contractual terms that absolve them of liability and other punitive strictures while compelling users’ non-disclosure of their systems’ problematic, or even disastrous, software faults.

In other words, health IT customers and users have a gag order imposed on them regarding software faults and defects.

I think any reasonable person would conclude there is great doubt as to whether "every incidence of [HIT side effects] is being reported."

I also pointed out in JAMA (link) and on my Drexel website (link) how agreeing to these terms caused hospital executives to violate both their fiduciary duties to their organization's workers as well as Joint Commission safety standards obligations.

(I've personally reported health IT defects I'd observed in hospitals where my relatives were patients to FDA's MAUDE database, discovering that the institution itself, whose officials I alerted to the problems, did not. An example is here.)

The above is all common sense.

Thus, the dismissal of reports of health IT-related patient injury, deaths, and "near misses" represents a failure of common sense, as well as a massive abrogation of fiduciary responsibilities and legal and ethical obligations among the Medical Informatics, health IT vendor, healthcare delivery, and healthcare regulatory sectors.

One end result is that it permits software like this to be mandated by state governments on hundreds of hospitals. One can only imagine the public, press and legal reactions if mission-critical software issues of this magnitude were brought forth after an aviation or nuclear power plant disaster.

The cavalier dismissals of HIT mishap reports clearly fall into the "knew, or should have known" category of negligence.

Plaintiff attorneys for patients injured or killed via HIT-related mishaps should take note.

-- SS

Note: my WSJ comment on this issue appears here.

NEJM: Medical Malpractice Liability in the Age of Electronic Health Records

As I wrote on Nov. 11 at Report of an AMIA special task force on challenges in ethics, safety, best practices, and oversight regarding HIT :

This report may be part of a trend ... It appears that the views on healthcare IT safety, ethics, management practices, etc. appearing on the Healthcare Renewal blog and on my once-controversial academic health IT website "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" (started in 1999) are now becoming mainstream.

Notable "events" continue to occur rapidly in the literature on clinical IT. Another example of the trend I noted appeared today, this time in the New England Journal of Medicine:

Medical Malpractice Liability in the Age of Electronic Health Records
Sandeep S. Mangalmurti, M.D., J.D., Lindsey Murtagh, J.D., M.P.H., and Michelle M. Mello, J.D., Ph.D.
N Engl J Med 2010; 363:2060-2067 (Nov. 18, 2010)

From the Department of Medicine, New York University Medical Center, New York (S.S.M.); and the Department of Health Policy and Management, Harvard School of Public Health, Boston (L.M., M.M.M.).

The above hyperlink takes you, as of this writing, to full text and an available PDF.

My comments on this article are that:

I am happy to see it appear -- as it shows that critical thinking about HIT has reached the top echelons of the medical literature.

However, the new paper itself appears to wander a bit, and seems to add little to the much more comprehensive article:

"E-Health Hazards: Provider Liability and Electronic Health Record Systems." Sharona Hoffman and Andy Podgurski. Berkeley Technology Law Journal (2010).
Available at: http://www.btlj.org/data/articles/24_4/1523_Hoffman.pdf

(Sharona Hoffman JD is Professor of Law and Bioethics, Co-Director of Law-Medicine Center, Case Western Reserve University School of Law, and Andy Podgurski PhD is Professor of Electrical Engineering and Computer Science, Case Western Reserve University.)

The new article does reference the Hoffman/Posgurski article once at [32].

The new NEJM article also seems to display biases. For instance, it states:

EHR users overwhelmingly report improvement in the quality of care they provide. [29]

Reference [29] is this article:

29. DesRoches CM, Campbell EG, Rao SR, et al. Electronic health records in ambulatory care — a national survey of physicians. N Engl J Med 2008;359:50-60.

From that article:

In late 2007 and early 2008, we conducted a national survey of 2758 [ambulatory care] physicians, which represented a response rate of 62%. Using a definition for electronic health records that was based on expert consensus, we determined the proportion of physicians who were using such records in an office setting and the relationship between adoption and the characteristics of individual physicians and their practices.

... Four percent of physicians reported having an extensive, fully functional electronic records system, and 13% reported having a basic system ... Physicians reported positive effects of these systems on several dimensions of quality of care and high levels of satisfaction ... Physicians who use electronic health records believe such systems improve the quality of care and are generally satisfied with the systems. However, as of early 2008, electronic systems had been adopted by only a small minority of U.S. physicians, who may differ from later adopters of these systems.

I would therefore relate that the blanket statement that "EHR users overwhelmingly report improvement in the quality of care they provide" is overstated.

It might have been more appropriate to write that:

"In one study of ambulatory care physicians, a minority of which at present were using EMR's at various levels of sophistication, users reported improved care."

Also, other literature refuting the premise that physicians report improved care could (should) have been considered, such as (in just one example) the 2008 survey reported upon by the American Association of Physicians and Surgeons (AAPS):

PHYSICIAN ATTITUDES & ADOPTION OF HEALTH INFORMATION TECHNOLOGY (PDF)

I wrote about that survey at this link. (I note that the AAPS is a conservative group; NYU and Harvard tend strongly towards the left; one wonders if the NEJM authors would have considered mentioning the AAPS survey, even if they did know of it.)

More potential biases appear in the conclusion of the new NEJM paper:

... In evaluating whether to invest in EHR technologies, provider organizations must weigh the substantial up-front cost and possible risks against the potentially sizeable, but uncertain, long-run benefits.[55]

[55] DesRoches CM, Campbell EG, Vogeli C, et al. "Electronic health records’ limited successes suggest more targeted uses." Health Aff (Millwood) 2010;29:639-46.

From [55]:

... We examined electronic health record adoption in U.S. hospitals and the relationship to quality and efficiency. Across a large number of metrics examined, the relationships were modest at best and generally lacked statistical or clinical significance. However, the presence of clinical decision support was associated with small quality gains. Our findings suggest that to drive substantial gains in quality and efficiency, simply adopting electronic health records is likely to be insufficient. Instead, policies are needed that encourage the use of electronic health records in ways that will lead to improvements in care.

Using [55] as an example of "potentially sizable but uncertain long-run benefits" is not how I would have interpreted the Health Affairs Millwood article.

The NEJM paper authors then write in their conclusion:

... The malpractice implications of EHRs should be included in future discussions of risks and benefits. [Agreed - ed.] Although there is currently little research quantifying the risks and benefits with respect to liability, we are optimistic that they will ultimately weigh in favor of the implementation of EHRs.

They do not state how or why they are optimistic, nor provide corroborating references for that opinion.

Is it revealing of bias and probably not a good practice, as far as I am concerned, to put what appears as wishful thinking -- especially where one states that there is little research supporting the optimism -- in the conclusion of a scientific paper.

In summary, while I feel the paper has a number of flaws, I am glad to see the topic of potential healthcare IT malpractice liability addressed in one of the top journals in medicine.

-- SS