healthy4u: medication reconciliation

Yes, it can.<br /><br />There's been yet another "glitch" in the world of health IT (see <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a> for more examples).<br /><br />"Glitch" is a banal term used by health IT extremists (those who have abandoned a  rigorous scientific approach to these medical devices as well as basic patient  protections, in favor of unwarranted and inappropriate overconfidence  and hyper-enthusiasm).  The term is used to represent  potentially injurious and lethal problems with health IT, usually  related to inadequate software vetting and perhaps even "sweatshop floor  in foreign country directly to production for U.S. hospital floors"  development processes (this industry is entirely unregulated).<br /><br />This from Siemens Healthcare:<br /><br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhae-yXD6c2_12_evEvfXooZahy8chrcA9i-9emaRiiLjhepoqQrXLrAvpylkMci6nKV4xjNzHvIb63yLOJ1KgYfGgmm1iqmvVyTm4207vzFOgE42H-dUEDrRwiF2pmb3tL_wrNDZjAoMeZ/s1600/siemens.bmp" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhae-yXD6c2_12_evEvfXooZahy8chrcA9i-9emaRiiLjhepoqQrXLrAvpylkMci6nKV4xjNzHvIb63yLOJ1KgYfGgmm1iqmvVyTm4207vzFOgE42H-dUEDrRwiF2pmb3tL_wrNDZjAoMeZ/s400/siemens.bmp" width="308" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Click to enlarge.  Text below.</td></tr></tbody></table><br />Text of this "Safety Advisory Notification":<br /><br /><blockquote class="tr_bq">August 1, 2013<br /><br />Safety Advisory Notification<br />Soarian® Clinicals Medication Reconciliation EV06736602<br /><br />Dear Customer:<br /><br />This notification is to inform you that Soarian Clinicals Medication Reconciliation 3.3 <b>may not be operating properly in some cases.</b><br /><br />Although this may affect only some customers, we are taking a conservative approach and are alerting you to this potential problem. As such, please forward this notification to appropriate personnel as soon as possible.</blockquote><blockquote>This letter is being sent as a precautionary measure as <b>there have been no adverse events reported from customers.</b></blockquote><br />They mean "<i>no adverse events reported - yet.</i>"  And if such events had been reported, Siemens would most certainly not make them public.  (Why should they, when there are no regulations?) <br /><br /><blockquote class="tr_bq">When does this issue occur and what are the potential risks?</blockquote><blockquote>This issue occurs when a user <b>moves a free text in-house order from the current and home medications side (left side) to the discharge medication side (right side)</b>, and then modifies the continued free text in-house order in discharge reconciliation prior to saving the discharge reconciliation list. After the modification of the continued free text medication order,<b> the changes to the free text medication order are not recorded in the saved discharge medication list.  <span style="color: red;"><i>[In other words, the changes to medication orders the user just typed <u>disappear into thin air</u>.  I note that medication reconciliation failures are among the most common causes of medical error - ed.]</i></span></b></blockquote><br />The health IT extremists would invoke the "Leaned Intermediary" doctrine that lays all blame for errors on the user.  It seems the only way to avoid such liability would be after every "enter" or "save" action (or perhaps every keystroke?), users then verify what was saved or entered...<br /><br />The "fix" to this "glitch" is not too far off from that:<br /><br /><blockquote class="tr_bq">Immediate steps you should take to avoid the potential risk of this issue:<br /><br />To prevent this issue from occurring at your facility,<b> instruct users not to modify continued free text in-house orders on the discharge medication list.</b> Users may be instructed to enter free text in-house orders manually by selecting the add prescription action button and entering the order.</blockquote><br />This is known as a "workaround."  Anyone who believes this edict can and will be 100% reliably followed in often chaotic medical environments, by users from medical students to nurses to physicians, is truly cavalier.<br /><br /><blockquote class="tr_bq">Steps that Siemens is taking to correct this complaint:<br /><br />We are diligently working to develop a correction<b> and will test and deliver it as soon as possible.</b></blockquote><br />Perhaps FDA and Joint Commission need to inquire about exactly what testing and QC was done on the current code, testing that (if actually performed) did not detect this glaring and Siemens-admitted safety-risk "glitch."<br /><br />-- SS

Another Health IT "Glitch" - Can Digital Disappearing Ink Kill Patients?

Yes, it can. There's been yet another "glitch" in the world of health IT (see http://hcrenewal.blogspot.com/search/label/glitc...

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I submitted this complaint to the Joint Commission today.<br /><br />I've been challenging them in recent years (especially since my JAMA letter "<span id="scm6MainContent_lblArticleTitle"><a href="http://jama.jamanetwork.com/article.aspx?articleid=184302" target="_blank">Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards</a>"</span> on hospital executive's violation of JC Safety Standards of July 2009) over the issue of their accreditation of  hospitals using bad health IT.<br /><br />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.)<br /><br />Here is my complaint submitted both via email and via the Joint Commission "<a href="http://www.jointcommission.org/report_a_complaint.aspx" target="_blank">Report a Complaint online</a>" page.  I added a few comments for readers in <i style="color: red;"><b>[bold red italics]</b></i> that, of course, were not part of the submission: <br /><br />------------------------------<br /><br />Thank you for submitting your complaint!     Monday, August 20, 2012<br /><br />Your complaint incident number is:     ########-########<br /><br />------------------------------<br /><br />Dear Joint Commission,<br /><br /><div class="MsoNormal">I also sent this complaint to<a href="mailto:PSchyve@jointcommission.org" target="_blank"></a> PSchyve, AGiuntoli and MChassin via email.</div><div class="MsoNormal"><br /></div><div class="MsoNormal">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 #######-######.</div><div class="MsoNormal"><br /></div><div class="MsoNormal">I am also filing the issue below as a formal JC complaint:</div><div class="MsoNormal"><br /></div><div class="MsoNormal">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.  </div><div class="MsoNormal"><br /></div><div class="MsoNormal">I am assuming they passed Joint Commission Accreditation that includes the ability to ensure continuity of care, including giving correct meds via Med Recon.</div><div class="MsoNormal"><br /></div><div class="MsoNormal">The hospital through defense counsel today (8/20/12) writes in a document I've placed at [URL redacted]:  <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/00235447.pdf" target="_blank"></a></div><div class="MsoNormal"><br /></div><blockquote class="tr_bq"><div class="MsoNormal">... 4.  As plead <i style="color: red;"><b>[sic -ed.]</b></i>, the <a href="http://legal-dictionary.thefreedictionary.com/gravamen" target="_blank">gravamen</a> <i style="color: red;"><b>[the basic gist of every claim or charge in a complaint<span class="st"> - ed.] </span></b></i>of Plaintiffs complaint is the <b>allegation that he told the treating professionals about Mrs. Silverstein's Sotalol medication.</b></div><div class="MsoNormal"><br /></div><div class="MsoNormal">5.  Therefore, <b>the central issue of this case is one of human communication</b>- i.e., whether Dr. Silverstein told the various staff or not.  <i style="color: red;"><b>[In other words, their obligations to check medications end there - ed.]</b></i></div></blockquote><div class="MsoNormal"><br /></div><div class="MsoNormal">In fact, the complaint was quite clear:</div><div class="MsoNormal"><br /></div><div class="MsoNormal">...32.  The tortious conduct of defendant [name redacted]  Hospital consisted of the following:</div><div class="MsoNormal"><br /></div><blockquote class="tr_bq"><div class="MsoNormal">a. vicarious liability for the actions of its agents [redacted], [redacted] and [redacted] <b>to ensure continuation of the Sotalol therapy <i style="color: red;">[can we all agree that's a primary responsibility of a hospital and its agents? - ed.];</i></b></div><div class="MsoNormal"><br /></div><div class="MsoNormal">b. vicarious liability for the actions of its agents [redacted], [redacted] and [redacted]<b> to ensure proper operation of the defendant’s EMR system so as to ensure continuation</b> of a presently active medication;</div><div class="MsoNormal"><br /></div><div class="MsoNormal">c. vicarious liability for the failure of its agents identified in this complaint <b>to adequately communicate Ms. Silverstein’s complete medication history with the subsequent treating health care providers</b>during this admission;</div><div class="MsoNormal"><br /></div><div class="MsoNormal">d. vicarious liability for the failure of its agents, identified in this complaint, <b>to question why no Sotalol was ordered given the noted history of arrhythmia</b> <i style="color: red;"><b>[a medical student-level question - ed.];</b></i></div><div class="MsoNormal"><br /></div><div class="MsoNormal">e. failure to have in place adequate procedures or policies to insure <b>that presently active medications are continuously active in the EMR system unless deactivated by an appropriately qualified health care provider</b>;</div><div class="MsoNormal"><br /></div><div class="MsoNormal">f. failure to have in place adequate procedures or policies to insure that the computer <b>generates appropriate alerts for others to see when critical medications become inactive;</b></div><div class="MsoNormal"><br /></div><div class="MsoNormal">g. failure to properly assess the operational effectiveness of its EMR system so as to <b>insure that presently active medications are automatically continued unless specifically deactivated</b> by a qualified and authorized health care provider.</div></blockquote><div class="MsoNormal"><br /></div><div class="MsoNormal">33. As a result of the above identified failures in medication administration and medical record charting, Ms. Silverstein has suffered the following:</div><div class="MsoNormal"><br /></div><blockquote class="tr_bq"><div class="MsoNormal">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. </div></blockquote><div class="MsoNormal"><br /></div><div class="MsoNormal">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, <b>this hospital seems to believe its Med Recon responsibilities end at the family - </b>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.</div><div class="MsoNormal"><br /></div><div class="MsoNormal">I note (as I had previously sent you) <b>that Pennsylvania's Medicare QIO, Quality Insights, found the hospital had failed in medication continuity</b>, and that the failure to administer Sotalol caused the recurrent A. fib and subsequent complications, the care not meeting professionally accepted standards. <i style="color: red;"><b>[The formal terminology for "malpractice" - ed.]</b></i></div><div class="MsoNormal"><br /></div><div class="MsoNormal">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.</div><div class="MsoNormal"><br /></div><div class="MsoNormal">Sincerely,</div><div class="MsoNormal"><br /></div><div class="MsoNormal">S. Silverstein,  MD</div><div class="MsoNormal"><br /></div><div class="MsoNormal">Cc:  [attorney handling the malpractice lawsuit]</div><div class="MsoNormal"><br /></div><div class="MsoNormal">- end complaint -</div><div class="MsoNormal"></div><div class="MsoNormal"><br />--------------------</div><div class="MsoNormal"><br /></div><div class="MsoNormal">They defense is also trying to deflect the Judge from the issue of Metadata:<br /><br /><blockquote class="tr_bq">... 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, <b>then the fact that medical record does not record this as a current medication has nothing to do with metadata. </b></blockquote><br />Wrong. <br /><br /><i><b>"The fact that medical record does not record Sotalol as a current medication</b>" </i>after the ED encounter on 5/19/10 indicates a forensic examination of the metadata is crucial.<br /><br />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 <a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html" target="_blank">at this link</a> in a case that settled for over $1 million before a trial even began.<br /><br />In fact, over and above potentially misrepresenting my and my mother's stated medication history at ED triage:<br /><br />Note their attempting to deflect attention away from health IT and the med recon failure of their own staff.   <br /><br />Also note a reckless understanding of Medication Reconciliation, that seems to imply <b>the hospital believes it had no duty to reconcile meds with itself, </b>that is, check its own EHR or paper records from just a few weeks prior<b> </b>along with multiple others dating back 8 years, or<b> check with the hospital-affiliated primary care and other physicians</b> treating the patient for years, who were reachable via a simple phone call.  Instead,<b> </b>the issue of whether a family member told <i>"them about the med or not"</i> seems to be their central defense. <b>  </b><br /><br />On the issue of who's actually responsible (and liable) for Med Recon, from the American Medical Association monograph entitled "<a href="http://www.ama-assn.org/resources/doc/cqi/med-rec-monograph.pdf" target="_blank">The physician’s role in medication reconciliation</a>", pg. 3.   <br /><br /><blockquote class="tr_bq">... The essence of medication reconciliation is <b>making sense of a patient’s medications and resolving conflicts between different sources of information</b> <i style="color: red;"><b>[paper, electronic, verbal, information from other physicians treating the patient, etc. - ed.]</b></i> to minimize harm<b> </b>and to maximize therapeutic effects. It is an ongoing, dynamic, episodic and team-based process that should be led by and is the <b>responsibility of the patient’s attending</b> or personal physician <b>in collaboration with</b> <b>other health care professionals</b>. 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 <b>for which physicians are ultimately held legally accountable. </b></blockquote><br />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:<br /><br /><blockquote class="tr_bq">... 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 <b>requires close attention by potential users to ensure that implementation does not create additional pressures and problems with accuracy of medications.</b></blockquote><br />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.<br /><br />Of course, <b>it's also possible</b> that the defense is <a href="http://hcrenewal.blogspot.com/2012/08/defense-attorney-lies-under-oath-to.html" target="_blank">just making stuff up again</a> to try to blow smoke up the judge's behind.  However, what's sworn certainly should not be lightly dismissed.  <br /><br />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. </div><div class="MsoNormal"><br /></div><div class="MsoNormal">-- SS</div>

Did Joint Commission Accredit a Hospital Whose Understanding of Medication Reconciliation is Recklessly Superficial?

I submitted this complaint to the Joint Commission today. I've been challenging them in recent years (especially since my JAMA letter ...

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