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

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 "Health Care Information Technology, Hospital Responsibilities, and…

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Joint Commission Should Be Named As Defendant If Patients Harmed by EHR "Outages"

At my recent post "<a href="http://hcrenewal.blogspot.com/2012/08/massive-health-it-outage-but-of-course.html">Massive Health IT Outage: But, Of Course, Patient Safety Was Not Compromised</a>" over a massive, outrageous Cerner outage to hospitals contracting their clinical IT via an <a href="http://en.wikipedia.org/wiki/Application_service_provider" target="_blank">ASP model</a> (that is, 'software as a service'), I observed:<br /><br /><blockquote class="tr_bq">... The Joint Commission, for example, likely issued its stamp of approval for the affected hospitals, hospitals who had outsourced their crucial medical records functions to an outside party that sometimes went mute.  If someone was injured or died due to this outage, they would not care very much about the supposed advantages.</blockquote><br />From the JC's page "<a href="http://www.jointcommission.org/about_us/about_the_joint_commission_main.aspx" target="_blank">About the Joint Commission</a>":<br /><br /><blockquote class="tr_bq"><b>An independent, not-for-profit organization</b>, The Joint Commission accredits and certifies more than 19,000 health care organizations and programs in the United States. Joint Commission accreditation and certification is <b>recognized nationwide as a symbol of quality that reflects an organization’s commitment to meeting certain performance standards.</b></blockquote><br />It's time to up the ante regarding this accreditation body, fully aware of health IT risks (e.g., the Dec 2008 <a href="http://hcrenewal.blogspot.com/2008/12/joint-commission-sentinel-events-alert.html" target="_blank">Sentinel Events Alert on Health IT</a>) but to date having done little about them.  Through my legal work and my speaking to Plaintiff's attorneys, I am becoming increasingly aware of medical malpractice cases that  involve an EHR or related clinical IT systems at JC-accredited organizations.<br /><br />In effect, the JC has accredited hospitals whose entire clinical command-and-control structure (the term EHR is an anachronism; these systems are in reality <b>enterprise clinical resource management and clinician workflow control devices</b>)<b> </b>can disappear in the blink of an eye, without warning, raising risk to patients greatly.<br /><br />If I discover that a patient was harmed or killed as a result of, or related to, this massive recent outage of outsourced medical records/workflow control  infrastructure, I will be recommending that the Joint Commission, including its leadership, which likely certified the hospital(s) involved for safe operations in areas such as Information Management, <i><b>be named </b></i><i><b>as defendants.</b></i><br /><br />I have informed the JC leadership by email<i><b>.</b></i><br /><i><b> </b></i> <br />-- SS

Joint Commission Should Be Named As Defendant If Patients Harmed by EHR "Outages"

At my recent post "Massive Health IT Outage: But, Of Course, Patient Safety Was Not Compromised" over a massive, outrageous Cerner outage to hospitals contracting their clinical IT via an ASP model (…

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Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost - Supreme Court-Style

<span style="font-size:100%;"><span style="font-family:arial;">At my Sept. 2010 post "</span><a style="font-family: arial;" href="http://hcrenewal.blogspot.com/2010/09/dangers-of-critical-thinking-in.html"><span>T</span>he Dangers of Critical Thinking in A Politicized, Irrational Culture</a><span style="font-family:arial;">" I wrote:</span><br /><br /></span><blockquote style="font-family:arial;"><span style="font-size:100%;"><span style="font-size:100%;">... It's the EMR "anecdotalists" </span><span style="font-size:100%;"><span>(as opposed to the "</span><a href="http://www.blogger.com/redir.aspx?C=dc7b9da405614c5dbab920a23075d904&URL=http%3a%2f%2fonline.wsj.com%2farticle%2fSB122910977401502369.html%3fmod%3dloomia%26loomia_si%3dt0%3aa16%3ag2%3ar3%3ac0.0175368%3ab0" target="_blank"><span>Markopolists</span></a><span>") who say that "anecdotes" of HIT-related injury are meaningless. They deem reports of safety issues and HIT-related misadventures and risk as simply "anecdotal", and that "anecdotes don't make evidence" (or "anecdotes don't make data").</span></span></span></blockquote><span style="font-size:100%;"><br /></span><span style=";font-family:arial;font-size:100%;" >For "anecdotes" of patient harm due to medical devices even from the most reliable of sources to be counted as "evidence" of device risk, apparently, the stories need to be blessed with Statistical Holy Water. The Holy Water must also be of a brand approved by the academic pundits.<br /><br />For me, this is no longer merely a professional debate. My elderly relative became one of those "anecdotes" in May last year.<br /><br />I address the casual, Dogbert-style, waving-of-the-hand "Bah!" dismissal of health IT harm "anecdotes" at numerous other posts as well, such as "</span><span style="font-size:100%;"><a style="font-family: arial;" href="http://hcrenewal.blogspot.com/2011/01/ehr-problems-no-theyre-merely.html">EHR Problems? No, They're Merely Anecdotal</a></span><span style=";font-family:arial;font-size:100%;" >" and "</span><span style="font-size:100%;"><a style="font-family: arial;" href="http://hcrenewal.blogspot.com/2010/09/health-it-on-anecdotalism-and.html">Health IT: On Anecdotalism and Totalitarianism</a></span><span style=";font-family:arial;font-size:100%;" >".<br /><br /></span><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjC3R-neGSEVG6YHlF2_aqr3l_TIiwnLOVuprTMHik2msljNENb9cbk8yfkczzdbnzm3vXf5s1MSAybYAwwEdk4qPThRR8mDgKozEtleyGagJOM7rQY7xomFQXq1-z5nKatfhw-Fhc5m5MN/s1600/dilbert_bah.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5588746392800329890" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjC3R-neGSEVG6YHlF2_aqr3l_TIiwnLOVuprTMHik2msljNENb9cbk8yfkczzdbnzm3vXf5s1MSAybYAwwEdk4qPThRR8mDgKozEtleyGagJOM7rQY7xomFQXq1-z5nKatfhw-Fhc5m5MN/s320/dilbert_bah.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 122px; height: 102px;" /></a><span style="font-style: italic;font-size:85%;" >Bah! Your Health IT adverse events reports are anecdotes, and anecdotes don't make data!</span><br /></div><span style=";font-family:arial;font-size:100%;" ><br />In those posts I also mention how Australian informatics professor Dr. Jon Patrick had essentially hit the flaws of this argument out of the Southern hemisphere with a short editorial in the journal "Applied Clinical Informatics" entitled "</span><span style="font-size:100%;"><a style="font-family: arial;" href="http://aci.schattauer.de/en/contents/archive/issue/1124/manuscript/15463/show.html">The Validity of Personal Experiences in Evaluating HIT</a></span><span style=";font-family:arial;font-size:100%;" >." That essay is free at the link and is worth reading.</span><span style="font-size:100%;"><br /><br /><span style="font-family:arial;">Interestingly and thankfully, the "anecdotes are meaningless" crowd have now lost, and lost big - Supreme Court style. In fact, the U.S. Supreme Court has shown far more common sense than many esteemed academics and industry pundits.</span><br /><br /><span style="font-family:arial;">As noted in </span><a style="font-family: arial;" href="http://pipeline.corante.com/archives/2011/03/25/the_supreme_court_slams_big_pharma_not_exactly.php">this post</a><span style="font-family:arial;"> at Derek Lowe's pharmaceutical industry "In the Pipeline" blog, the company that made "Zicam", a zinc-based over-the-counter cold remedy, tried to defend shareholder suits that the company withheld case reports of Zicam causing permanent loss of smell via arguing that such reports "<span style="font-weight: bold;">did not reach a level of statistical significance</span>", i.e., were "anecdotal." The case went to the U.S. Supreme Court.</span><br /><br /><span style="font-family:arial;">The Supreme Court would have none of that argument:</span><br /></span><span style="font-style: italic;"><br /><blockquote>"Matrixx’s <span style="font-weight: bold; color: rgb(255, 0, 0);">[Zicam's manufacturer - ed.]</span> premise that statistical significance is the only reliable indication of causation is flawed. Both medical experts and the Food and Drug Administration <span style="font-weight: bold;">rely on evidence other than statistically significant data to establish an inference of causation</span>. It thus stands to reason that reasonable investors would act on such evidence. </blockquote><br /></span><span style="font-size:100%;"><span style="font-family:arial;">The full court decision is at this link: </span><a style="font-family: arial;" href="http://www.supremecourt.gov/opinions/10pdf/09-1156.pdf">http://www.supremecourt.gov/opinions/10pdf/09-1156.pdf</a><span style="font-family:arial;"> (PDF file), but a passage I consider key to this issue is as follows:</span><i style="font-family: arial;"><br /></i></span><br /><blockquote style="font-style: italic;">... 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 <span style="font-weight: bold;">fact-specific inquiry, requiring consideration of their source, content, and context.</span> </blockquote><br /><span style="font-size:100%;"><span style="font-family:arial;">This is common sense incarnate. It applies not just to drugs, but to medical devices, to health IT, and to other domains as well.</span><br /><br /><span style="font-family:arial;">In essence, it is saying that adverse events reports, especially repeated ones, from trustworthy sources are not to be lightly dismissed, but should serve at the very least as red flags that there may be a systemic problem requiring further investigation.</span><br /><br /><span style="font-family:arial;">One wonders how and if public healthcare IT vendors will begin disclosing "anecdotal" reports of their products causing patient harm to their own stockholders.</span><br /><br /><span style="font-family:arial;">One also wonders if the academic anecdotalists (up to the level of the chair of the </span><a style="font-family: arial;" href="http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__onc/1200">Office of the National Coordinator for Health Information Technology</a><span style="font-family:arial;"> at HHS) will cease their unfettered dismissal of health IT AE reports as mere "anecdotes" and therefore let's roll out this 100% beneficent technology nationwide ASAP:</span><span style="font-family:arial;"></span><br /><br /></span><blockquote style="font-family:arial;"><span style="font-size:100%;">"Nothing [ONC has] found would give them any pause that a policy of introducing EMR's could impede patient safety." - David Blumenthal<br /></span></blockquote><span style="font-size:100%;"><br /><span style="font-family:arial;">That sounds a bit like the refrain of the makers of Zicam.</span><br /><br /><span style="font-family:arial;">One might also wonder if the anecdotalists merely lack common sense, or are using this form of </span></span><span style="font-style: italic;font-family:arial;font-size:100%;" >epistemological dementia</span><span style="font-size:100%;"><span style="font-family:arial;"> to obscure conflict of interest.<br /><br />On a final note, my favorite comment at the aforementioned "In the Pipeline" blog story is this by anonymous commenter "<a href="http://pipeline.corante.com/archives/2011/03/25/the_supreme_court_slams_big_pharma_not_exactly.php#486785">Still Scared of Dinosaurs</a>":<br /><br /></span></span><blockquote>One of the most important ideas real statisticians must get into their heads is "Thou shalt not worship the 0.05 threshold". The whole concept of "statistical significance" for AEs is idiotic and the fact that Matrixx based any part of their defense on it indicates that their stupidity did not end when they named the company.</blockquote><br />Perhaps this Dilbert cartoon is apropos to the Supreme Court decision:<br /><br /><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjpWvtHM2V4woNCenRHGJBsn5bL2lnegSGbsn6NLY-al4u1RXF9vsMrbkECBhDJvRAGg2DNSe298h2dNiNetm9f54jUTxDwmFFYPchyphenhyphenaKz8y8mP16rRDeGIIMIHPsg-utiJIN9ZGOjkrfS6/s1600/dogbert.gif"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5588746949773253554" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjpWvtHM2V4woNCenRHGJBsn5bL2lnegSGbsn6NLY-al4u1RXF9vsMrbkECBhDJvRAGg2DNSe298h2dNiNetm9f54jUTxDwmFFYPchyphenhyphenaKz8y8mP16rRDeGIIMIHPsg-utiJIN9ZGOjkrfS6/s320/dogbert.gif" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 138px; height: 135px;" /></a><br />-SS<br /><br /><span style="font-weight: bold;">Addendum:</span><br /><br />I thought it appropriate to share these thoughts with the leadership of the <a href="http://www.jointcommission.org/">Joint Commission</a>, the organization that accredits healthcare organizations in the United States:<br /><span style="font-size:130%;"><br /></span><div style="direction: ltr;" id="divRpF355968"><span style="color: rgb(0, 0, 0);font-family:Tahoma;font-size:130%;" ><b></b></span></div><blockquote><div style="direction: ltr;font-family:arial;" id="divRpF355968"><span style="color: rgb(0, 0, 0);font-size:130%;" ><b>From:</b> Scot Silverstein<br /><b>Sent:</b> Sunday, March 27, 2011 10:41 AM<br /><b>To:</b> MGiuntoli, Anita; Chassin, Mark; Schyve, Paul; Legaspi, Shirley<br /><b>Cc:</b> Ross Koppel; 'David Kreda'<br /><b>Subject:</b> Re: MATRIXX INITIATIVES, INC., ET AL. v. SIRACUSANO ET AL.<br /></span><span style="font-size:130%;"><br /></span></div> <div> <div face="Arial" size="13px" style="direction: ltr; color: rgb(0, 0, 0);"> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"><span style="color: rgb(0, 0, 0);font-size:130%;" >Not a complaint this time<span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);"> [about health IT failure - ed.]</span>, but an observation.</span><span style="font-size:130%;"><br /><br />The JC has noted health IT risks in the Sentinel Events Alert "<a href="http://www.jointcommission.org/assets/1/18/SEA_42.PDF">Safely implementing health information and converging technologies</a>" of 2008.<br /><br />The company that made "Zicam", a zinc-based over-the-counter cold remedy, tried to defend shareholder suits that the company withheld case reports of Zicam causing permanent loss of smell via arguing that such reports "<span style="font-weight: bold;">did not reach a level of statistical significance</span>", i.e., were "anecdotal." The case went to the U.S. Supreme Court.<br /><br />The Supreme Court would have none of that argument:<br /><blockquote style="font-family:arial;"><br /><i>"Matrixx’s <span style="color: rgb(255, 0, 0); font-weight: bold;">[Zicam's manufacturer]</span> premise that statistical significance is the only reliable indication of causation is flawed. Both medical experts and the Food and Drug Administration rely on evidence other than statistically significant data to establish an inference of causation. It thus stands to reason that reasonable investors would act on such evidence. </i></blockquote><i><br /></i>The full court decision is at this link: <a href="http://www.supremecourt.gov/opinions/10pdf/09-1156.pdf" target="_blank">http://www.supremecourt.gov/opinions/10pdf/09-1156.pdf</a> (PDF file), but a passage I consider key to this issue is as follows:<i><br /><br /></i> <blockquote style="font-family:arial;"><i>... Because adverse reports can take many forms, <span style="font-weight: bold;">assessing their materiality is a fact-specific inquiry, requiring consideration of their source, content, and context</span>.</i></blockquote><br />This is common sense incarnate. It applies not just to drugs, but to medical devices, to health IT, and to other domains as well.<br /><br /></span></div> <div dir="ltr" style="font-family: arial;"> </div> <div dir="ltr" face="arial"><span style="font-size:130%;">I believe JC should start to pay serious attention to "anecdotal reports" of health IT-caused patient injury, and <strong>consider reliable reporting of these events as an Accreditation standard.<br /><br /></strong></span></div> <div dir="ltr" face="arial"><span style="font-size:130%;"><strong></strong></span> </div> <div dir="ltr" style="font-family: arial;"><span style="font-size:130%;">As I noted in my July 2009 JAMA letter to the editor "<a href="http://jama.ama-assn.org/content/302/4/382.1.extract" target="_blank">Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards</a>" in response to Koppel and Kreda's <a href="http://jama.ama-assn.org/content/301/12/1276.extract" target="_blank">JAMA article</a> on HIT industry practices, "hold harmless" and "gag" clauses must go, and be replaced with proactive reporting of healthcare IT-related "events."<br /><br /></span></div> <div style="font-family: arial;" dir="ltr"> </div> <div dir="ltr" style="font-family: arial;"><span style="font-size:130%;">Scot Silverstein</span></div> <div dir="ltr"><br /></div></div></div></blockquote>-- SS<br /><span style="font-size:100%;"><span style="font-family:arial;"></span></span>

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Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost - Supreme Court-Style

At my Sept. 2010 post "The Dangers of Critical Thinking in A Politicized, Irrational Culture" I wrote:... It's the EMR "anecdotalists" (as opposed to the "Markopolists") who say that "anecdotes" o…

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Making Hospitals Safer by Making Healthcare IT Safer

<span><span style=";font-family:Default Sans Serif,Verdana,Arial,Helvetica,sans-serif;font-size:100%;" ><span><span><span style=";font-family:Default Sans Serif,Verdana,Arial,Helvetica,sans-serif;font-size:100%;" ><span style=";font-family:Default Sans Serif,Verdana,Arial,Helvetica,sans-serif;font-size:100%;" ><span style="font-size:100%;"><span style="font-family:Arial,Default Sans Serif,Verdana,Arial,Helvetica,sans-serif;"> </span><span style="font-family:Arial,Default Sans Serif,Verdana,Arial,Helvetica,sans-serif;">At my July 24, 2009 HC Renewal post "<a href="http://hcrenewal.blogspot.com/2009/07/inquiry-to-joint-commission-on-points-i.html">Inquiry to Joint Commission on points raised in my July 22, 2009 JAMA letter on HIT</a>", I reproduced a letter I sent to the Joint Commission seeking their opinions on the issue of Health IT "hold harmless" and "defects nondisclosure" contractual terms. (See "<a href="http://jama.ama-assn.org/cgi/content/extract/301/12/1276">Health Care Information Technology Vendors' Hold Harmless Clause - Implications for Patients and Clinicians</a>", JAMA 2009;301(12):1276-1278 and my HIT difficulties website essay <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=koppel_kreda">here</a>.)<br /><br />Those contractual terms cause hospital executives to violate Joint Commission safety standards and their own fiduciary responsibilities to people both providing and seeking care in hospitals. My inquiry was acknowledged, and I await a reply.<br /><br /></span></span></span></span></span></span></span></span><span><span style=";font-family:Default Sans Serif,Verdana,Arial,Helvetica,sans-serif;font-size:100%;" ><span style="font-family:arial;"><span><span style="font-size:100%;"><span style="font-size:100%;"><span style="font-size:100%;">In<span style="font-weight: bold;"> <a href="http://www.nytimes.com/2009/08/03/opinion/l03medical.html?_r=2&ref=todayspaper">Making Hospitals Safer for Patients</a></span>, New York Times, Aug. 2, 2009 , Mark R. Chassin, </span></span></span></span></span><span class="italic" style="font-family:arial;">president of The Joint Commission, </span><span><span><span style=";font-family:Default Sans Serif,Verdana,Arial,Helvetica,sans-serif;font-size:100%;" ><span style=";font-family:Default Sans Serif,Verdana,Arial,Helvetica,sans-serif;font-size:100%;" ><span style=";font-family:arial;font-size:100%;" > wrote:<br /><br /></span><div style="margin-left: 40px; font-family: arial;"><p>To the Editor:</p><p>Jim Hall makes an important point about the costs and preventability of harm caused by medical errors, but his suggestion for a National Medical Safety Board is not the answer. It is not sufficient to investigate health care “crashes” one at a time and hope to transform the health care system into one that performs more reliably.</p>Too often, the lessons learned are not easily transferable to other hospitals or even to other problems within the same organization.<br /><br /><span style="font-size:100%;"><span style="font-style: italic;">The key to transforming our health care system into a safer one is to <span style="font-weight: bold;">use proven quality improvement methods </span>— already in use in high-risk fields like aviation and nuclear power — as part of everyday work ... </span><br /></span></div><span style=";font-family:arial;font-size:100%;" ><br /><br />In a followup email to the Joint Commission, I pointed out to Dr. Chassin that this is the same key to <span style="font-weight: bold;">improving the quality and safety of EHR, CPOE </span> and other information technology-based medical devices.<br /><br /></span><span style=";font-family:Default Sans Serif,Verdana,Arial,Helvetica,sans-serif;font-size:100%;" ><span style="font-family:arial;">I also pointed out that "Hold harmless" and "Defects nondisclosure" -- a.k.a. "gag clause" -- contractual methods (unless I'm mistaken, in which case we're all in jeopardy) are not used in building and deploying safety-critical devices found in the aviation and nuclear energy industries.</span><br /><br /><span style="font-family:arial;">-- SS</span><br /></span></span></span></span></span></span></span>

Making Hospitals Safer by Making Healthcare IT Safer

At my July 24, 2009 HC Renewal post "Inquiry to Joint Commission on points raised in my July 22, 2009 JAMA letter on HIT", I reproduced a letter I sent to the Joint Commission seeking their opinions …

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Inquiry to Joint Commission on points I raised in my July 22, 2009 JAMA letter on HIT

As I posted <a href="http://hcrenewal.blogspot.com/2009/07/health-care-information-technology.html">here</a>, my letter "<i>Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards</i>" was published in JAMA on July 22, 2009. A preview of the letter can be seen <a href="http://jama.ama-assn.org/cgi/content/extract/302/4/382">here</a>, or a full version <a href="http://jama.ama-assn.org/cgi/content/full/302/4/382">here</a> if you subscribe to JAMA.<br /><br />This JAMA letter covered some of the same points I addressed extensively at my Drexel HIT website essay "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=koppel_kreda"><i>Hold Harmless and Keep Defects Secret Clauses</i></a>", including the major point that <span>hospital executives signing HIT "Hold Harmless" and "Defects Nondisclosure" contracts </span><span style="font-weight: bold;">are in violation of Joint Commission standards for conduct related to safety, and in violation of their fiduciary responsibilities </span><span>towards patient and employee safety and freedom from undue liability</span>.<br /><br />I've sent the following inquiry to Paul M. Schyve, M.D., Senior Vice President, The Joint Commission:<br /><br /><span style=";font-family:arial;font-size:100%;" ></span><blockquote><span style=";font-family:arial;font-size:100%;" >July 24, 2009<br /><br />Paul M. Schyve, M.D.<br />Senior Vice President<br />The Joint Commission<br /></span><a class="Addr" title="Create new mail memo with this address" href="javascript:noop()" onclick="BuK('schyve%40jointcommission.org')">schyve@jointcommission.org</a><br /><br /><span style=";font-family:arial;font-size:100%;" >Cc: </span><a class="Addr" title="Create new mail memo with this address" href="javascript:noop()" onclick="BuK('MChassin%40jointcommission.org')">MChassin@jointcommission.org</a>, <a class="Addr" title="Create new mail memo with this address" href="javascript:noop()" onclick="BuK('otrippi%40jointcommission.org')">otrippi@jointcommission.org</a><br /><span style=";font-family:arial;font-size:100%;" ><br />Dear Dr. Schyve,<br /><br />In testimony to the House Committee on Veterans' Affairs on July 22, 2009 <a target="blank" href="http://veterans.house.gov/hearings/Testimony.aspx?TID=45015&Newsid=438&Name=%20Paul%20M.%20Schyve,%20M.D.">at this link </a>, you state:<br /><br /><p style="margin-left: 40px;">... The Joint Commission has established standards that require the hospital to: </p> <ul style="margin-left: 40px;" type="disc"><li>Create a culture in which adverse events are reported and evaluated for underlying ("root") causes, and preventative actions are taken. </li><li>Identify high-risk processes and prospectively determine their possible modes of failure, the effects of those failures, and the actions that will prevent the failures or mitigate their effects. </li><li>Establish a culture of safety throughout the hospital. This accreditation standard became effective January 1, 2009, although its purpose and expectations were publicized for over a year in advance. </li></ul><br />In my JAMA letter to the editor of July 22, 2009 entitled " <span style="font-weight: bold;">Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" </span> ( <a target="blank" href="http://jama.ama-assn.org/cgi/content/extract/302/4/382">link </a>), I point out that the Hold Harmless and Defects Nondisclosure clauses signed by hospital executives in contracting for healthcare information technology (such as CPOE and EHR systems) are in violation of Joint Commission safety standards, as well as hospital executive fiduciary responsibilities to patients and clinicians. These clinical IT systems can and do cause medical errors and patient harm.<br /><br />My letter was in response to Koppel and Kreda's March 25, 2009 article " <a target="blank" href="http://jama.ama-assn.org/cgi/content/extract/301/12/1276">Health Care Information Technology Vendors' "Hold Harmless" Clause: Implications for Patients and Clinicians </a>", JAMA. 2009;301(12):1276-1278.<br /><br />I am interested in the Joint Commission's response to the issues I raise.<br /><br /></span></blockquote>I await a response.<br /><br />-- SS

Inquiry to Joint Commission on points I raised in my July 22, 2009 JAMA letter on HIT

As I posted here, my letter "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" was published in JAMA on July 22, 2009. A preview of the letter can be se…

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