I submitted this complaint to the Joint Commission today.
I've been challenging them in recent years (especially since my JAMA letter "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" on hospital executive's violation of JC Safety Standards of July 2009) over the issue of their accreditation of hospitals using bad health IT.
Eventually, I hope, they will take a leadership role on health IT risk, lest they become a target for litigation. (I think they're already there for their inaction on EHR problems despite admitted knowledge of the problems, in print, e.g., in their 2009 Sentinel Events Alert on Health IT Risks.)
Here is my complaint submitted both via email and via the Joint Commission "Report a Complaint online" page. I added a few comments for readers in [bold red italics] that, of course, were not part of the submission:
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Thank you for submitting your complaint! Monday, August 20, 2012
Your complaint incident number is: ########-########
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Dear Joint Commission,
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I've been challenging them in recent years (especially since my JAMA letter "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" on hospital executive's violation of JC Safety Standards of July 2009) over the issue of their accreditation of hospitals using bad health IT.
Eventually, I hope, they will take a leadership role on health IT risk, lest they become a target for litigation. (I think they're already there for their inaction on EHR problems despite admitted knowledge of the problems, in print, e.g., in their 2009 Sentinel Events Alert on Health IT Risks.)
Here is my complaint submitted both via email and via the Joint Commission "Report a Complaint online" page. I added a few comments for readers in [bold red italics] that, of course, were not part of the submission:
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Thank you for submitting your complaint! Monday, August 20, 2012
Your complaint incident number is: ########-########
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Dear Joint Commission,
You are already aware of the injury and death from Med Recon failure of my mother at [name redacted] Hospital, in an incident that began May 19, 2010. Reference Incident #######-######.
I am also filing the issue below as a formal JC complaint:
As demonstrated in the sworn defense response by [name redacted] Hospital today, 8/20/12, the hospital has a very superficial understanding of Med Recon and Med Recon Failure.
I am assuming they passed Joint Commission Accreditation that includes the ability to ensure continuity of care, including giving correct meds via Med Recon.
The hospital through defense counsel today (8/20/12) writes in a document I've placed at [URL redacted]:
... 4. As plead [sic -ed.], the gravamen [the basic gist of every claim or charge in a complaint - ed.] of Plaintiffs complaint is the allegation that he told the treating professionals about Mrs. Silverstein's Sotalol medication.5. Therefore, the central issue of this case is one of human communication- i.e., whether Dr. Silverstein told the various staff or not. [In other words, their obligations to check medications end there - ed.]
In fact, the complaint was quite clear:
...32. The tortious conduct of defendant [name redacted] Hospital consisted of the following:
a. vicarious liability for the actions of its agents [redacted], [redacted] and [redacted] to ensure continuation of the Sotalol therapy [can we all agree that's a primary responsibility of a hospital and its agents? - ed.];b. vicarious liability for the actions of its agents [redacted], [redacted] and [redacted] to ensure proper operation of the defendant’s EMR system so as to ensure continuation of a presently active medication;c. vicarious liability for the failure of its agents identified in this complaint to adequately communicate Ms. Silverstein’s complete medication history with the subsequent treating health care providersduring this admission;d. vicarious liability for the failure of its agents, identified in this complaint, to question why no Sotalol was ordered given the noted history of arrhythmia [a medical student-level question - ed.];e. failure to have in place adequate procedures or policies to insure that presently active medications are continuously active in the EMR system unless deactivated by an appropriately qualified health care provider;f. failure to have in place adequate procedures or policies to insure that the computer generates appropriate alerts for others to see when critical medications become inactive;g. failure to properly assess the operational effectiveness of its EMR system so as to insure that presently active medications are automatically continued unless specifically deactivated by a qualified and authorized health care provider.
33. As a result of the above identified failures in medication administration and medical record charting, Ms. Silverstein has suffered the following:
a. Intracranial hemorrhage; b. atrial fibrillation; c. damage to her nerves and nervous system, including memory difficulties, and seizure activity; d. brain compression due to the intracranial hemorrhage; e. requirement for additional procedures; f. prolonged hospitalizations; g. need for rehabilitation; h. need for continuous therapies; i. pain, suffering, embarrassment, humiliation, and the loss of life’s pleasures; j. death.
While I gave the history of Sotalol to the clinicians on 5/19/10 (my mother had been on it dating to 2002) as I had done multiple times in this ED, this hospital seems to believe its Med Recon responsibilities end at the family - even when they have records in abundance in their paper records and EHRs (ED and floor), including from just a few weeks prior, with current med lists.
I note (as I had previously sent you) that Pennsylvania's Medicare QIO, Quality Insights, found the hospital had failed in medication continuity, and that the failure to administer Sotalol caused the recurrent A. fib and subsequent complications, the care not meeting professionally accepted standards. [The formal terminology for "malpractice" - ed.]
If you accredited this hospital, as I believe you did, this superficial understanding of Med Recon that you apparently missed or recklessly glossed over poses a serious danger to the community, and contributed materially to my mother's injuries, suffering and death.
Sincerely,
S. Silverstein, MD
Cc: [attorney handling the malpractice lawsuit]
- end complaint -
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They defense is also trying to deflect the Judge from the issue of Metadata:
Wrong.
"The fact that medical record does not record Sotalol as a current medication" after the ED encounter on 5/19/10 indicates a forensic examination of the metadata is crucial.
It is in fact only through metadata that it can be determined if the medication, listed as "current" only a few weeks prior and normally visible when the user brings up a patient's record to initiate triage, was deleted by the user (e.g., via "use error" per NIST, related to bad IT design) and how and when; if it ended up in another patient's chart due to malfunction (misidentification); if the EHR malfunctioned and simply erased the med; if the chart was altered to try to hide the mistake, etc. These are all well known failure modes. See an example of what metadata can show at this link in a case that settled for over $1 million before a trial even began.
In fact, over and above potentially misrepresenting my and my mother's stated medication history at ED triage:
Note their attempting to deflect attention away from health IT and the med recon failure of their own staff.
Also note a reckless understanding of Medication Reconciliation, that seems to imply the hospital believes it had no duty to reconcile meds with itself, that is, check its own EHR or paper records from just a few weeks prior along with multiple others dating back 8 years, or check with the hospital-affiliated primary care and other physicians treating the patient for years, who were reachable via a simple phone call. Instead, the issue of whether a family member told "them about the med or not" seems to be their central defense.
On the issue of who's actually responsible (and liable) for Med Recon, from the American Medical Association monograph entitled "The physician’s role in medication reconciliation", pg. 3.
The AMA monograph has a special section starting on p. 20 on IT and Med Recon. It warns explicitly about practicing medicine like a mindless robot:
The apparent hospital misunderstanding of Med Recon could - and in my view, should - result in charges of gross negligence, perhaps criminal, against its medical leadership if other patients have been, or are, harmed as a result of resultant medication reconciliation errors.
Of course, it's also possible that the defense is just making stuff up again to try to blow smoke up the judge's behind. However, what's sworn certainly should not be lightly dismissed.
I also note that this hospital is making a spectacle of itself in front of the Judge, the President Judge in the county where it conducts operations, who already dismissed a boatload of meritless claims. That does not bode well for them in the future.
... At this point in time, it is respectfully submitted that the proposed electronic discovery is not relevant to the central issue of this case. For example, if the Triage Nurse and subsequent providers were all to testify that Dr. Silverstein never informed them that Sotalol was a current medication of Mrs, Silverstein, then the fact that medical record does not record this as a current medication has nothing to do with metadata.
Wrong.
"The fact that medical record does not record Sotalol as a current medication" after the ED encounter on 5/19/10 indicates a forensic examination of the metadata is crucial.
It is in fact only through metadata that it can be determined if the medication, listed as "current" only a few weeks prior and normally visible when the user brings up a patient's record to initiate triage, was deleted by the user (e.g., via "use error" per NIST, related to bad IT design) and how and when; if it ended up in another patient's chart due to malfunction (misidentification); if the EHR malfunctioned and simply erased the med; if the chart was altered to try to hide the mistake, etc. These are all well known failure modes. See an example of what metadata can show at this link in a case that settled for over $1 million before a trial even began.
In fact, over and above potentially misrepresenting my and my mother's stated medication history at ED triage:
Note their attempting to deflect attention away from health IT and the med recon failure of their own staff.
Also note a reckless understanding of Medication Reconciliation, that seems to imply the hospital believes it had no duty to reconcile meds with itself, that is, check its own EHR or paper records from just a few weeks prior along with multiple others dating back 8 years, or check with the hospital-affiliated primary care and other physicians treating the patient for years, who were reachable via a simple phone call. Instead, the issue of whether a family member told "them about the med or not" seems to be their central defense.
On the issue of who's actually responsible (and liable) for Med Recon, from the American Medical Association monograph entitled "The physician’s role in medication reconciliation", pg. 3.
... The essence of medication reconciliation is making sense of a patient’s medications and resolving conflicts between different sources of information [paper, electronic, verbal, information from other physicians treating the patient, etc. - ed.] to minimize harm and to maximize therapeutic effects. It is an ongoing, dynamic, episodic and team-based process that should be led by and is the responsibility of the patient’s attending or personal physician in collaboration with other health care professionals. Medication reconciliation is essential to optimize the safe and effective use of medications. It is one element in the process of therapeutic use of medications and medication management for which physicians are ultimately held legally accountable.
The AMA monograph has a special section starting on p. 20 on IT and Med Recon. It warns explicitly about practicing medicine like a mindless robot:
... IT systems and applications do have the potential to streamline the medication reconciliation process—especially assembling and storing patient information—and to provide the means to effectively transfer patient medication information across the continuum of care. However, health care technology is fragmented and requires close attention by potential users to ensure that implementation does not create additional pressures and problems with accuracy of medications.
The apparent hospital misunderstanding of Med Recon could - and in my view, should - result in charges of gross negligence, perhaps criminal, against its medical leadership if other patients have been, or are, harmed as a result of resultant medication reconciliation errors.
Of course, it's also possible that the defense is just making stuff up again to try to blow smoke up the judge's behind. However, what's sworn certainly should not be lightly dismissed.
I also note that this hospital is making a spectacle of itself in front of the Judge, the President Judge in the county where it conducts operations, who already dismissed a boatload of meritless claims. That does not bode well for them in the future.
-- SS
