An Open Letter to David Bates, MD, Chair, ONC FDASIA Health IT Policy Committee on Recommendations Against Premarket Testing and Validation of Health IT

From <a href="http://www.healthit.gov/policy-researchers-implementers/federal-advisory-committees-facas/fdasia">http://www.healthit.gov/policy-researchers-implementers/federal-advisory-committees-facas/fdasia</a>:<br /><br /><blockquote class="tr_bq">The Food and Drug Administration Safety Innovation Act (FDASIA) <b>Health IT Policy Committee Workgroup</b> is charged with providing expert input on issues and concepts identified by the Food and Drug Administration (FDA), Office of the National Coordinator for Health IT (ONC), and the Federal Communications Commission (FCC) to inform the development of a report on an appropriate, risk-based regulatory framework pertaining to health information technology including mobile medical applications that promotes innovation, protects patient safety, and avoids regulatory duplication.</blockquote><br />My Open Letter to the Committee's chair speaks for itself:<br /><br /><blockquote class="tr_bq">From: Scot Silverstein<br />Date: Mon, Sep 16, 2013 at 9:39 AM<br />Subject: ONC FDASIA Health IT Policy Committee's recommendations on Premarket Surveillance<br />To: David Bates<br /><br />Sept. 16, 2013<br /><br />David Bates, Chair, ONC FDASIA Health IT Policy Committee<br />via email<br />    <br />Dear David,<br /><br />I am disappointed (and in fact appalled) at the ONC FDASIA Health IT Policy Committee's recommendations that health IT including typical commercial EHR/CPOE systems not be subjected to a premarket testing and validation process.  I believe this recommendation is, quite frankly, negligent. <b>[1]</b><br /><br />As you know, my own mother was injured and then died as a result of EHR deficiencies, and nearly injured or killed again in the recuperation period from her initial injuries by more health IT problems in a second EHR used in her care.  In my legal consulting and from my colleagues, as well as from the literature, I hear about other injuries/deaths and many "near misses" as well.  That your recommendations came in the face of the recent ECRI Deep Dive study is even more appalling, with the latter's finding of 171 health IT-related incidents in 9 weeks from 36 member PSO hospitals, resulting in 8 injuries and 3 possible deaths, all reported voluntarily. <b>[2]</b><br /><br />It is my expert opinion the issues that cause these outcomes would never have made it into production systems, had a reasonable, competent, unbiased premarket testing and validation process been in place.<br /><br />Consequently, I have shared the FDASIA HIT Policy Committee's recommendations with the Plaintiff's Bar, and will use its recommendations in my presentations to various chapters of the American Association for Justice (the trial lawyer's association) - as well as to interested Defense attorneys so they may advise their clients accordingly.<br /><br />I am also making recommendations that in any torts, individual or class, regarding EHR problems that would likely have been averted with competent premarket testing and validation, that the FDASIA HIT Policy Committee members who agreed with the recommendation be considered possible defendants.<br /><br />I am sorry it has come to this.<br /><br />Please note I am also posting this message for public viewing at the Healthcare Renewal weblog of the Foundation for Integrity and Responsibility in Medicine (FIRM).<br /><br />Sincerely,<br /><br />Scot Silverstein, MD<br />Consultant/Independent Expert Witness in Healthcare Informatics<br />Adjunct Faculty, Drexel University, College of Computing and Informatics<br /><br />Notes:<br /><br /><br />[1] FDA Law Blog, Recommendations of FDASIA Health IT Workgroup Accepted, September 11, 2013, available at <a href="http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/09/recommendations-of-fdasia-health-it-workgroup-accepted.html">http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/09/recommendations-of-fdasia-health-it-workgroup-accepted.html</a>: "Of particular interest is the recommendation that health IT should generally not be subject to FDA premarket requirements, with a few exceptions:  medical device accessories, high-risk clinical decision support, and higher risk software use cases."<br /><br />[2] "Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI 'Deep Dive' Study of Health IT Events" , Feb. 28. 2013, available at <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>.</blockquote><br />----------------------------------------------- <br /><br />Note: the following are listed on the linked site above as members of the committee:<br /><br /><div>Member List</div><ul><li><b>David Bates, Chair</b>, Brigham and Women’s Hospital</li><li><b>Patricia Brennan</b>, University of Wisconsin-Madison</li><li><b>Geoff Clapp</b>, Better</li><li><b>Todd Cooper</b>, Breakthrough Solutions Foundry, Inc.</li><li><b>Meghan Dierks</b>, Harvard Medical Faculty, Division of Clinical Informatics</li><li><b>Esther Dyson</b>, EDventure Holdings</li><li><b>Richard Eaton</b>, Medical Imaging & Technology Alliance</li><li><b>Anura Fernando</b>, Underwriters Laboratories</li><li><b>Lauren Fifield</b>, Practice Fusion, Inc.</li><li><b>Michael Flis</b>, Roche Diagnostics</li><li><b>Elisabeth George</b>, Philips Healthcare</li><li><b>Julian Goldman</b>, Massachusetts General Hospital/ Partners Healthcare</li><li><b>T. Drew Hickerson</b>, Happtique, Inc.</li><li><b>Jeffrey Jacques</b>, Aetna</li><li><b>Robert Jarrin</b>, Qualcomm Incorporated</li><li><b>Mo Kaushal</b>, Aberdare Ventures/National Venture Capital Association</li><li><b>Keith Larsen</b>, Intermountain Health</li><li><b>Mary Anne Leach</b>, Children’s Hospital Colorado</li><li><b>Meg Marshall</b>, Cerner Corporation</li><li><b>Mary Mastenbrook</b>, Consumer</li><li><b>Jackie McCarthy</b>, CTIA - The Wireless Association</li><li><b>Anna McCollister-Slipp</b>, Galileo Analytics</li><li><b>Jonathan Potter</b>, Application Developers Alliance</li><li><b>Jared Quoyeser</b>, Intel Corporation</li><li><b>Martin Sepulveda</b>, IBM</li><li><b>Joseph Smith</b>, West Health</li><li><b>Paul Tang</b>, Palo Alto Medical Foundation</li><li><b>Bradley Thompson</b>, Epstein Becker Green, P.C</li><li><b>Michael Swiernik</b>, MobileHealthRx, Inc.</li></ul>Federal Ex Officios<br /><ul><li><b>Jodi Daniel</b>, ONC</li><li><b>Bakul Patel</b>, FDA</li><li><b>Matthew Quinn</b>, FCC</li></ul><br /> -- SS<b><br /></b>

An Open Letter to David Bates, MD, Chair, ONC FDASIA Health IT Policy Committee on Recommendations Against Premarket Testing and Validation of Health IT

From http://www.healthit.gov/policy-researchers-implementers/federal-advisory-committees-facas/fdasia:The Food and Drug Administration Safety Innovation Act (FDASIA) Health IT Policy Committee Workgro…

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Did Toxic Effects of an EHR Kill Rory Staunton?

A stunning story about the death of a young man from sepsis (blood poisoning by infection), missed in an ED, appeared in the New York Times:<br /><br /><blockquote class="tr_bq"><b><a href="http://www.nytimes.com/2012/07/12/nyregion/in-rory-stauntons-fight-for-his-life-signs-that-went-unheeded.html" target="_blank">An Infection, Unnoticed, Turns Unstoppable</a></b><br /><br />By JIM DWYER<br />New York Times<br />Published: July 11, 2012<br /><br />For a moment, an emergency room doctor stepped away from the scrum of people working on Rory Staunton, 12, and spoke to his parents. <br /><br />“Your son is seriously ill,” the doctor said.<br /><br />“How seriously?” Rory’s mother, Orlaith Staunton, asked.<br /><br />The doctor paused.<br /><br />“Gravely ill,” he said.<br /><br />How could that be?<br /><br />Two days earlier, diving for a basketball at his school gym, Rory had cut his arm. He arrived at his pediatrician’s office the next day, Thursday, March 29, vomiting, feverish and with pain in his leg. He was sent to the emergency room at NYU Langone Medical Center. The doctors agreed: He was suffering from an upset stomach and dehydration. He was given fluids, told to take Tylenol, and sent home.<br /><br />Partially camouflaged by ordinary childhood woes, Rory’s condition was, in fact, already dire. Bacteria had gotten into his blood, probably through the cut on his arm. He was sliding into a septic crisis, an avalanche of immune responses to infection from which he would not escape. On April 1, <b>three nights after he was sent home from the emergency room, he died in the intensive care unit.</b> The cause was <b>severe septic shock</b> brought on by the infection, hospital records say.  </blockquote><br />Rory Staunton, age 12, 5 feet 9 inches tall and 169 pounds, had suffered a cut on his arm.  He presented with a marked fever of 102 F (39 C), pulse markedly elevated at 131, respiratory rate elevated at 22; reported to have hit as high as 36 breaths per minute (in essence, panting).  It was reported by the NYT that before the ED visit his parents said his temperature had reached 104 F (40 C).<br /><br />That alone should have set off some level of concern.  (It is possible narrative details of his history never made it into the ED chart; ED EHR's are often templated point-and-click affairs that can impair or discourage capture of narrative.)<br /><br />Per the NYT, the bacteria <a href="http://pyogenesgonewild.com/">Streptococcus pyogenes</a> normally dwells in the throat or on the skin, areas where the body is well defended.  Also known as Group A streptococcus, the strain typically causes strep throat or impetigo.  However, if it gets into the blood stream (e.g., via a cut in the skin, as this patient suffered playing ball), the results can be devastating.<br /><br />The lab results from the first ED visit are <i>particularly</i> stunning:<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/AVvXsEipLbK3DLugjbsbvM8pGrbG_NaVc9WeUrAm2PSATK9oeoyzPyBzQ2yMKufnd0St8g9gMqH-Gqzk1dBmfp2KIbN1DseGU2gQVrJRrCrPyzViWxs3c9sRl2p1VYb5hW4cHh4wtIFglMGBGmVk/s1600/labs.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="395" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEipLbK3DLugjbsbvM8pGrbG_NaVc9WeUrAm2PSATK9oeoyzPyBzQ2yMKufnd0St8g9gMqH-Gqzk1dBmfp2KIbN1DseGU2gQVrJRrCrPyzViWxs3c9sRl2p1VYb5hW4cHh4wtIFglMGBGmVk/s400/labs.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">(From NYT article; click to enlarge)</td><td class="tr-caption" style="text-align: center;"><br /></td><td class="tr-caption" style="text-align: center;"><br /></td></tr></tbody></table><br />The white blood cell count is markedly elevated at 14.7, meaning 14,700 cells per microliter of blood (cubic millimeter or 1 mm³).  Further, there is a plain evidence of greatly accelerated new white cell production, in the form of <b>"bands"</b>, at <b>53% </b>of the total (normally 5-15%).  <b><b>Bands</b> </b>are immature white blood cells that are seen in the blood, being produced as part of the body's response to infection.<br /><br />Herein is a significant issue.  The NYT noted that:<br /><br /><blockquote class="tr_bq">"Three hours later <i style="color: red;"><b>[i.e., after the ED visit, which reportedly only lasted 2 hours - ed.]</b></i>, Rory’s blood tests came back. High levels of neutrophils and “bands” – immature white blood cells – are evidence of infection. <b>But nobody called the Stauntons, and by the time Rory returned to the hospital the next day, his infection was unstoppable. He died two days later.</b>"</blockquote><br />Not getting into the issue regarding the patient apparently being discharged before the labs got back (itself an invitation to disaster), and the other abnormalities such as low sodium, low platelets, elevated glucose all pointing to a very sick patient... <b>nobody called the Stantons with white cell results like these?   </b>Nobody entertained the thought of ...<b> antibiotics as a precaution?</b><br /><br />It is possible - dare I say likely - that no clinical person in the ED ever saw these results.<br /><br />EHR's that are poorly designed or implemented can have a toxic effect on care.  For instance, EHR's can cause user confusion if the user interface is complex, data can be lost due to poor relational design.  Data from the wrong patient's data can be presented (misidentification), or data from a lab can come back to the system after a patient has left, and despite being abnormal, <b>just sit there in a silo without being looked at ("out of sight, out of mind"; a "silent silo" syndrome).</b><br /><br />It is usually difficult to ascertain exactly which EHR product is being used at a particular hospital.  I note this medical center actively promoted its EPIC EHR<b> </b>in a June 2011 press release "<a href="http://communications.med.nyu.edu/media-relations/news/nyu-langone-medical-center-launches-next-phase-its-electronic-health-record-sys" target="_blank">NYU Langone Medical Center Launches Next Phase of Its Electronic Health Record System</a>", although another system "ICIS"  (for <i>Integrated Clinical Information System</i>, "<i>a state-of-the-art healthcare information management system that connects all NYULMC caregivers involved in patient care</i>") is mentioned <a href="http://icis.med.nyu.edu/about/whatis.html" target="_blank">here</a>.  The ICIS may also contain the Eclipsys Sunrise Clinical Manager, per <a href="http://icis.med.nyu.edu/about/history.html" target="_blank">this link</a>. (I'd noted some clinically relevant problems with the latter in an FDA report <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=1729552" target="_blank">here</a>.)<br /><br />In any case, magical powers are attributed to the technology that are not strongly or uniformly supported by the literature (<a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html" target="_blank">link</a>), but strongly pushed by industry marketing memes of deterministic health IT benefits and absolute beneficence:<br /><br /><blockquote class="tr_bq">“... Our electronic health record system is an integral part of our ongoing efforts to leverage technology and enhance our ability to provide patient-centered care and enable the highest level of quality care management,” said Bernard A. Birnbaum, MD, senior vice president and vice dean, chief of hospital operations at NYU Langone. “These front-end and back-end services are an important step in assuring our patient’s experience from beginning to end is a seamless one.”</blockquote><br />I've documented examples of situations where EHR's and other IT components of clinical ERP systems <i>(enterprise resource planning and management systems, a term that more accurately describes what exists in many hospitals now than the misleading, file cabinet-evoking term "EHR")</i> contributed to or caused patient harm, such as at "<a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html" target="_blank">Babies' deaths spotlight safety risks linked to computerized systems</a>" - a computer error caused a central line placement x-ray to have gone unread, leading to death; "<a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html" target="_blank">The Sweet death that wasn't very sweet</a>" - a missing "difficult intubation" EHR flag led to a middle-aged man suffocating during an intubation attempt; and others.  An Australian researcher thoroughly studied the potential risks of an EHR meant specifically for ED's ("<a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146" target="_blank">A Study of an Enterprise Health information System</a>", PDF executive summary <a href="http://sydney.edu.au/engineering/it/%7Ehitru/essays/Pt%200%20-%20Executive%20Summary.pdf" target="_blank">at this link</a>).<br /><br />The following passage in the NYT article also offers another clue:<br /><br /><blockquote class="tr_bq">... Two hours later, though, he had three [signs of sepsis]: his temperature had risen to 102, his pulse was 131 and his respiration rate was 22. But by the time those vital signs were recorded, at 9:26 p.m., they had no bearing on his treatment. In fact, the doctor had already decided that Rory was going home. <b>Rory’s “ExitCare” instructions, signed by his father, were printed 12 minutes before those readings.  </b></blockquote><br />Did those readings escape notice due to delayed charting (data entry), a common problem with EHRs in busy clinical environments?<br /><br />The Institute of Medicine in its 2011 <b>IOM report on health IT safety</b> admitted harms are reported but the magnitude of harms is unknown due to multiple reporting impediments, as did the FDA in its 2010 <b>internal memo on "H-IT Safety Issues"</b> divulged by the Huffington Post Investigative Fund (see <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html" target="_blank">here</a> and <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">here</a>).  The National Institute of Standards and Technology (NIST) admits in its <b>2011 report on HIT usability</b> that EHR usability is often poor and may lead to "use error" (error caused or promoted by poor design, as distinguished from simple user error, see <a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html" target="_blank">here</a>), magnitude of problem also unknown.<br /><br />In a startling medical situation such as Rory Stanton's, where crucial labs seem to have evaporated causing or contributing to delayed treatment of a devastating and obvious illness, <b>I believe EHR-related factors need to be examined and ruled out <u>first</u>.</b><br /><br />For, quite simply, if the EHR caused or contributed to this tragic debacle, <i>the public could be at risk</i>. <b><br /></b><br /><br />-- SS<br /><br />Additional thought:  could this be the "cybernetic <a href="http://en.wikipedia.org/wiki/Libby_Zion_law" target="_blank">Libby Zion</a> case" I've written of?<br /><br />-- SS<br /><br /><b>July 18, 2012 Addendum:</b><br /><br />The Stauntons, who appeared on the NBC Today Show are seeking to create a “Rory’s Law” in New York to ensure that parents have full access to blood and lab tests done on their children as soon as results are available, and that a doctor will be present to assess the findings. Story <a href="http://www.irishcentral.com/news/Rorys-Law---major-effort-underway-to-ensure-kids-kept-safe-in-ER-162842926.html" target="_blank">here</a>.<br /><br />-- SS <br />

Did Toxic Effects of an EHR Kill Rory Staunton?

A stunning story about the death of a young man from sepsis (blood poisoning by infection), missed in an ED, appeared in the New York Times:An Infection, Unnoticed, Turns UnstoppableBy JIM DWYERNew Yo…

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An Expensive Healthcare Computing Mistake: $1.5 Million

At my June 2011 post "<a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">Babies' deaths spotlight safety risks linked to computerized systems</a>" I reported on a case (case #2) of an infant death in part attributed to HIT (PACS) interference in otherwise simple care processes.<br /><br />In "Allen-Blake vs. Abington Memorial Hospital", a critical x-ray of a PICC (<a href="http://en.wikipedia.org/wiki/Peripherally_inserted_central_catheter"><span style="font-style: italic;">peripherally inserted central catheter</span></a>) line placement allegedly was never read due to misdating.<br /><br />The Allen-Blake case was settled 2/29/12 for $1.5 million, according to the public docket count 78 (<a href="http://webapp.montcopa.org/PSI/Viewer/Detail.aspx?oq=aWQ9MjAwNzcwODI4JmVudGl0eT1DYXNl">link</a>):<br /><br /><table class="ChamaeleonGrid" rules="all" border="1" cellspacing="0"><tbody><tr class="GridItem"><td>2/29/2012</td><td>Order</td><td>OF 2/28/12 OTT, J PROPOSED SETTLEMENT OF <span style="font-weight: bold;">$1,500,000.00 </span>APPROVED CC </td></tr></tbody></table><br />That $1.5 million might have paid for a lot of other things, such as provision of better medical care through hiring/retention of more staff. The legal fees for defense incurred must also have been substantial, representing yet more precious healthcare capital down the proverbial drain.<br /><br />Add cases like this to the "total cost of ownership" of health IT.<br /><br />-- SS

An Expensive Healthcare Computing Mistake: $1.5 Million

At my June 2011 post "Babies' deaths spotlight safety risks linked to computerized systems" I reported on a case (case #2) of an infant death in part attributed to HIT (PACS) interference in otherwise…

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Propofol and Other Drug Questions: Was Michael Jackson a UPMC Patient at the Same Time as Samuel Sweet?

At my Sept. 24, 2011 post "<a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html">UPMC and the Sweet death that wasn't very sweet: How EMRs can detract from a clear narrative, and facilitate spoliation and obfuscation of evidence</a>" I wrote a detailed summary of a civil medical malpractice Complaint regarding possible electronic chart alteration. As I pointed out, that Complaint made EMR metadata visible to laypeople for the first time that I am aware.<br /><br />A new docket has appeared in that case entitled "<span style="font-weight: bold;">Interrogatories to Defendant</span>" from Attorney/physician Deborah Maliver dated Sept. 27, 2011.<br /><br />This document is <span style="font-weight: bold;">publicly downloadable</span> from the Pittsburgh Prothonotary Office Civil Docket site <a href="https://dcr.alleghenycounty.us/SelectCaseID.asp?filename=Welcome.htm&NoLoginRequired=yes" target="_blank">at this link</a>, case #<span>GD-09-019407, </span><span>document #55, or at my cached version <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/lawsuits/Sweet_second_omnibus_discovery_request_vol1025000001C2.pdf">at this link</a> (PDF)</span>.<br /><span><br />It brings up questions of even greater concern to me as a physician, those of mysterious drug orders for powerful sedatives such as propofol, fentanyl and etomidate. Apparently the metadata makes it difficult to account for what could be questioned as "over-generous" dispensing of those drugs.<br /><br />(This is ironic, since the trial of the doctor who administered this drug to deceased singer Michael Jackson has itself <a href="http://www.washingtonpost.com/national/after-jurors-hear-of-michael-jacksons-promise-pain-manslaughter-trial-moves-into-2nd-day/2011/09/28/gIQA037n3K_story.html">just gotten underway</a>.)<br /><br />Here is the first interrogatory request listing numerous drugs:<br /><br /><br /></span><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhz5UUn1fAdqG_C4hgdKbsZVqd8nSvaKZ-Qzu4FIOmkQwUaBnawjjlNLqYhEhlZ4JzBH7dv6EOtqPw01aQI-_eN2D5PNICxR-BX3ZRVqPDx8r37ZrUyUOqTQWsnTTx2od_CB4JegU-H1zu_/s1600/req_drugs.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5657422163070212418" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhz5UUn1fAdqG_C4hgdKbsZVqd8nSvaKZ-Qzu4FIOmkQwUaBnawjjlNLqYhEhlZ4JzBH7dv6EOtqPw01aQI-_eN2D5PNICxR-BX3ZRVqPDx8r37ZrUyUOqTQWsnTTx2od_CB4JegU-H1zu_/s320/req_drugs.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 320px; height: 205px;" /></a><span style="font-size:85%;">Question 1. Request for full metadata on these drugs<span style="font-weight: bold;"> (click to enlarge)</span><br /></span></div><span><br /><br />See Exhibit "A" from the new Interrogatory docket below, as produced in discovery earlier, and download the new Interrogatory in its entirety to see the questions asked about the other metadata:<br /><br /></span><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEifbEyA4JmFHLDEi9l7jeLeR49Edosxc81jdxE8L2ehKi0mo1XxAte2xJaH6Q9QY5MPjfgexHoFATqrU53bjf2ofDh3OsrQA00GJ4BRNAfAxpn1AZ6CXLa4QqK4KI0UHnQKWgWnGAnwkkjb/s1600/propofol.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5657414336191328802" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEifbEyA4JmFHLDEi9l7jeLeR49Edosxc81jdxE8L2ehKi0mo1XxAte2xJaH6Q9QY5MPjfgexHoFATqrU53bjf2ofDh3OsrQA00GJ4BRNAfAxpn1AZ6CXLa4QqK4KI0UHnQKWgWnGAnwkkjb/s320/propofol.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 381px; height: 221px;" /></a><span style="font-size:85%;">Exhibit "A". McKesson drug cabinet dispenser audit trail. Five 100-ml vials of <a href="http://en.wikipedia.org/wiki/Propofol">propofol</a> in a row from May 14-May 15? <a href="http://en.wikipedia.org/wiki/Lorazepam">Lorazepam</a> (ativan), propofol and <a href="http://en.wikipedia.org/wiki/Etomidate">etomidate</a> on May 15-16 at a time when a patient had a deteriorating respiratory status? (These drugs suppress the respiratory drive.) <span style="font-weight: bold;">Click to enlarge.</span><br /></span></div><span><br /><br />Question 4 is particularly disturbing:<br /><br /></span><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjlvErAEhoZ4kZTtYw4FQaahTK0l6pLTMpEiGMrkaERDnxCmpUGzhHHC3yqQ8hOCkcCri22GT_FK9t8Gneg1k4seXSmeUfX3Qvl1o0beyx6fHzz6sc5JX5rKEJNBiUXW_R7seh8HF8Np26H/s1600/do_not_appear.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5657423242222664578" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjlvErAEhoZ4kZTtYw4FQaahTK0l6pLTMpEiGMrkaERDnxCmpUGzhHHC3yqQ8hOCkcCri22GT_FK9t8Gneg1k4seXSmeUfX3Qvl1o0beyx6fHzz6sc5JX5rKEJNBiUXW_R7seh8HF8Np26H/s320/do_not_appear.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 380px; height: 147px;" /></a><span style="font-weight: bold;font-size:85%;" >(click to enlarge)</span><br /><br /><div style="text-align: left;"><br />Apparently none of these drugs appeared in the eMAR system, the electronic medication administration record. Where did they go? I hope the full audit trails will show a definitive final disposition of these drugs.<br /><br />One would hope a highly computerized medical center could keep track of its inventory of drugs of powerful potential for abuse with 100% certainty, <a href="http://en.wikipedia.org/wiki/Chain_of_custody">chain-of-custody</a> style (that means, 0% guesswork):<br /><br /><b></b><blockquote><b>Chain of custody</b> (CoC) refers to the chronological documentation or paper trail, showing the <span style="font-weight: bold;">seizure, custody, control, transfer, analysis, and disposition</span> of evidence, physical or electronic.</blockquote><br /></div></div><span>This is of concern to me as a former Occupational Medicine physician (in the transit industry) and a physician in general. I've seen drug abuse result in train wrecks - literally. Drug abuse/failure to be able to track disposition in a hospital would represent a prima facie <span style="font-weight: bold;">public health menace.</span><br /><br />There are also questions about whether users of the EMR signed in or used the accounts of other individuals, which is another weakness of the EMR. No handwriting to evaluate...<br /><br />-- SS<br /><br /><span style="font-weight: bold;">10/24/11 Addendum:</span><br /><br />Here is a horrible example of what can go wrong when drugs of abuse potential are not tracked with the utmost of rigor:<br /><br /><blockquote>Star Tribune/Minneapolis<br /><br /><a href="http://www.startribune.com/local/minneapolis/132140228.html">Abbott Northwestern patient left 'writhing in pain' sues</a><br /><br />"Hi, love," Sarah May Casareto greeted Larry V. King as he lay on a gurney before surgery. As they wheeled down the hall, he recalled in court records, she told him that he'd have to "man up" because they couldn't give him a lot of medication.<br /><br />The next 57 minutes of surgery were excruciating, according to a lawsuit filed Tuesday in Hennepin County District Court that accuses the drug-addicted former nurse of skimming his narcotics, which left him "writhing in pain" during a medical procedure for kidney stones last year at a Minneapolis hospital.<br /><br />Casareto, of Forest Lake, entered an Alford plea of guilty Sept. 1 to a fifth-degree controlled substance crime for possessing Fentanyl, a high-powered painkiller, and was sentenced to probation in connection with the Nov. 8 incident at Abbott Northwestern Hospital. The plea enabled Casareto to maintain her innocence while acknowledging ample evidence to convict her.<br /><br />The suit, which seeks at least $50,000 in damages, alleges that she was "negligent and careless" in her care for King, 57, of Bloomington. The suit also names Abbott as a defendant.<br /><br />It contends that Abbott "knew or should have known [before the procedure] that Casareto was exhibiting drug-seeking behavior and that she had become dependent upon narcotic pain medications." It also notes that Abbott officials knew that she had failed "on at least six different occasions" to properly handle patients' pain medication obtained from the hospital pharmacy.<br /><br />King's attorney, Tony Nemo, <span style="font-weight: bold;">called the lawsuit reflective of "a growing problem" that should draw closer scrutiny to drug diversion, or the theft of medications intended for patients.</span><br /><br />"One of the things I know Mr. King is hoping is that this case may cause Twin Cities hospitals to reveal procedures and protocols to, if not prevent, at least minimize this problem in the future," he said.</blockquote><br />I wonder if information technology problems regarding tracking of drugs with abuse potential existed.<br /><br />Read the whole article at the above link.<br /><br /></span><span>-- SS</span>

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Propofol and Other Drug Questions: Was Michael Jackson a UPMC Patient at the Same Time as Samuel Sweet?

At my Sept. 24, 2011 post "UPMC and the Sweet death that wasn't very sweet: How EMRs can detract from a clear narrative, and facilitate spoliation and obfuscation of evidence" I wrote a detailed su…

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UPMC and the Sweet death that wasn't very sweet: How EMRs can detract from a clear narrative, and facilitate spoliation and obfuscation of evidence

The world of electronic medical records is very secretive.<br /><br />Vendors will not allow their programs or data structures to be examined, even by the academic community. Their products, medical devices, are not vetted by regulatory agencies such as the FDA for quality.<br /><br />Patients and clinical personnel are supposed to take the word of the seller that these systems are fit for purpose and of high quality.<br /><br />A window into the internal working of EMR's was initiated Down Under just this year, in the form of a detailed internal analysis of an ED EMR product from America slated for roll-out in public hospitals in one of Australia's most populous states. Dr. Jon Patrick of the University of Sydney performed this work. He was not happy with what he found, in terms of software engineering, human computer interaction, and other issues related to fitness for purpose. See <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=120&Itemid=116">here</a> and <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">here</a>.<br /><br /><span style="font-size: 100%;">(</span><span style="font-size: 100%;">For more on healthcare IT difficulties, see "</span><span style="font-size: 100%; font-weight: bold;">Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties</span><span style="font-size: 100%;">" at this link: <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/</a>.)</span><br /><br />One component of the healthcare IT "ecosystem" many have been unable to see, which is perhaps even more carefully guarded than the program code and data structures, is the <span style="font-weight: bold;">metadata on EMR use.</span><br /><br /><span style="font-style: italic; font-weight: bold;">A remarkable development has now changed that metadata secrecy - a public civil lawsuit court docket.</span><br /><br />Metadata is "data about data." In this context, that means data about who accessed the EMR, what they did, when they did it, from where they did it, etc. Perhaps it should be deliberately misspelled as "<span style="font-weight: bold;">meat</span>data."<br /><br />It allows the "legible gibberish" (see my Feb. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html" target="_blank">Electronic Medical Records: Two Weeks, Two Reams</a>" for more on that term) produced by the clinical side of EMR to be better weaved into meat, that is, a medical narrative that is essential to truly understanding a case.<br /><br />I noted the unfortunate case of Samuel Sweet at the University of Pittsburgh Medical Center (UMPC), as reported by Sean Hamill in the Pittsburgh Post-Gazette:<br /><span style="font-size: 130%;"><br /></span><blockquote><span style="font-size: 130%;"><a href="http://www.post-gazette.com/pg/11262/1175874-114.stm" style="font-weight: bold;" target="_blank">Trial to begin in wrongful death claim</a></span><br /><span style="font-weight: bold;">Monday, September 19, 2011</span><br /><span style="font-weight: bold;">By Sean D. Hamill, Pittsburgh Post-Gazette</span><br /><br />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.<br /><br />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.<br /><br />Why he died is the subject of a civil case his family filed a few months later ... [Plaintiff's attorney] Ms. Maliver <span style="color: red; font-style: italic; font-weight: bold;">[actually Dr. Maliver, as she holds both the JD and MD degrees - ed.]</span> said UPMC's timeline came into question in early August 2011, when UPMC <span style="font-weight: bold;">finally turned over -- after two years of discovery</span> <span style="color: red; font-style: italic; font-weight: bold;">[i.e, they turned them over at the last minute, a few weeks before trial was scheduled to begin - ed.]</span> -- 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. <span style="color: red; font-style: italic; font-weight: bold;"><br /><br />[The patient died when there was a delay in treatment due to marked difficulty in putting a breathing tube into his lungs (a difficult intubation) when he developed respiratory failure. The defendants possibly never expected someone to actually comb through the 1,200 pages of "results detail sheets" on such a short time frame, but, apparently, the plaintiff's attorney took on the challenge - ed.]</span><br /><br />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.<br /><br />But the results detail sheets <span style="font-weight: bold;">also show something more troubling</span>, Ms. Maliver said.<br /><br />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" <span style="color: red; font-style: italic; font-weight: bold;">[difficult to intubate, due to anatomy - ed.] </span>red-letter warning on Mr. Sweet's electronic medical record. That effort showed up on the results details sheets, according to Ms. Maliver.<br /><br />Such a warning would tell <span style="color: red; font-style: italic; font-weight: bold;">["alert" would be a more precise term - ed] </span>anyone who opened the record that Mr. Sweet was difficult to intubate.<span style="font-weight: bold;"><br /></span></blockquote>As a result of this newspaper story, the defendants filed a complaint with the judge, who ordered a <span style="font-weight: bold;">six month delay in further proceedings</span>. The complaint and decision is <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/lawsuits/sweet_v_upmc_delay.pdf">at this link</a> (PDF).<br /><br />In further investigating what I considered a remarkable story, I came across a public docket Dr. Maliver filed on behalf of her clients in the case, "<span style="font-weight: bold;">PLAINTIFF'S MOTION AND SUPPORTING BRIEF TO AMEND COMPLAINT TO SEEK PUNITIVE DAMAGES</span>".<br /><br />As I mentioned previously, this is a<span style="font-weight: bold;"> remarkable development</span> that has opened a window on metadata secrecy.<br /><br />This is freely and publicly downloadable from the Pittsburgh Prothonotary Office Civil Docket site <a href="https://dcr.alleghenycounty.us/SelectCaseID.asp?filename=Welcome.htm&NoLoginRequired=yes" target="_blank">at this link</a>, case #GD-09-019407 , document #40 of 09/02/2011. (I have also cached the document at this link: <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/lawsuits/complaint_punitive_damages_vol101400000177.pdf" target="_blank">http://www.ischool.drexel.edu/<wbr></wbr>faculty/ssilverstein/cases/<wbr></wbr>lawsuits/complaint_punitive_<wbr></wbr>damages_vol101400000177.pdf</a> .)<br /><br />As I mentioned in the aforementioned post, I found the hospital attorney's explanation of apparent tampering somewhat troubling:<br /><br /><blockquote><span style="font-weight: bold;">Dr. Simmons wasn't trying to alter the record, [attorney for the defendants] Mr. Conti said</span>; instead he was in Mr. Sweet's medical record as part of the "peer review" process, assessing what happened in Mr. Sweet's case.<br /><br />As part of that, he was in the medical record three days after Mr. Sweet died trying to figure out <span style="font-weight: bold;">how one would create a warning about a patient's difficult intubation </span><span style="color: red; font-style: italic; font-weight: bold;">[in effect, altering the record, at the very least through creation of a confusing audit trail - ed.]</span>, Mr. Conti said.<br /><br /></blockquote>The public nature of the "<span style="font-weight: bold;">PLAINTIFF'S MOTION AND SUPPORTING BRIEF TO AMEND COMPLAINT TO SEEK PUNITIVE DAMAGES</span>" document makes it possible for the public to look at some of the actual metadata to see for themselves what might have occurred.<br /><br />Again, this is remarkable and is the first time I am aware of when the public (and the academic Medical Informatics community, of which I am a part) gets to "peek behind the curtain" of an EMR's metadata.<br /><br />Let's take a look.<br /><br />I will summarize relevant part of the Motion and intersperse testimony and metadata from the actual record of Mr. Sweet (again, from a now-public court document).<br /><br />The purpose of the Motion was to seek punitive damages:<br /><blockquote><br /><span style="font-weight: bold;">A. SEEKING PUNITIVE DAMAGES</span><br /><br />(1) This is a civil action for medical malpractice in which the Plaintiff alleges in essence that Samuel Sweet, a relatively healthy man of only 62 years of age, needlessly suffocated to death in the intensive care unit at UPMC after undergoing a routine cerebral angiogram when, the following day, physicians recklessly and prematurely pulled out his breathing tube and then could not get it back in when it became obvious Mr. Sweet would die without it.<br /><br />(2) This case is listed for trial on September 19, 2011, and discovery has just concluded.<br /><br />(3) In light of the evidence adduced in discovery, the Plaintiff seeks to amend the Complaint to re-characterize Defendant Murugan's and Defendant actions and inactions as willful, wanton, reckless and not merely negligent. The Plaintiff similarly seeks to amend the ad damnum clause against these defendants to include a request for punitive damages because of their shocking and reckless disregard for Mr. Sweet's welfare <span style="font-weight: bold;">and their attempts to alter the appearance of the medical records, in full awareness of Mr. Sweet's brain death, so as to obscure what really </span><span style="font-weight: bold;">happened. </span></blockquote><br />It is the last part of count A.(3) I will address here, a quite serious charge involving medical record evidence spoliation, which is specifically forbidden in Pennsylvania by the <span style="text-decoration: underline;"> </span><a href="http://www.portal.state.pa.us/portal/server.pt/document/495911/hb1802_pdf" target="_blank">Medical Care Availability and Reduction of Error (MCARE) Act of 2002</a> (PDF, see Section 511, "<span style="font-style: italic; font-weight: bold;">Preservation and accuracy of medical records</span>", pg. 18-19) and other regulations.<br /><br />Of importance, the Motion continues:<br /><br /><blockquote>... (15) UPMC has a special warning system that is intended to serve the very purpose of alerting all medical providers of a patient with a difficult airway. The way it works <span style="color: red; font-style: italic; font-weight: bold;">[as UMPC defendants testified under oath - ed.]</span> is the attending physician, writes up the problem list for the patient and <span style="font-weight: bold;">need only put difficult airway in the list, and this will trigger a special yellow banner to pop up on the patient's computer files for all to see every </span><span style="font-weight: bold;">time the chart is opened</span> and every time any page is viewed.<br /><br />Not only that, <span style="font-weight: bold;">but then the words "difficult airway"appear in red text within the yellow banner</span>, and this puts the viewers on notice to check the anesthesia record as to how intubation was done successfully in the past, so they can replicate the successful technique.</blockquote><br />This patient was extubated after a procedure to check for brain bleeding, but by late at night it became obvious he could not breathe adequately on his own, and needed to be re-intubated.<br /><br />Let's see how a chart appears with, and without the banner about a patient being difficult to intubate (due to their mouth and air-passage anatomy):<br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjepsPEUxRQrIrssZIL9cYrrRT64dcuyXhRbKbQi66MSYxU8mDE0bByXZDP5P_R8jSj67Kg5i3nthaFPW9qjmFJsoflVAiHZy832W8ZaaRUEd9mjs7k0xCbtpLxZfaI-7SqJ1moanOTSFNW/s1600/banners.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5656026922887887554" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjepsPEUxRQrIrssZIL9cYrrRT64dcuyXhRbKbQi66MSYxU8mDE0bByXZDP5P_R8jSj67Kg5i3nthaFPW9qjmFJsoflVAiHZy832W8ZaaRUEd9mjs7k0xCbtpLxZfaI-7SqJ1moanOTSFNW/s320/banners.jpg" style="cursor: pointer; display: block; height: 222px; margin: 0px auto 10px; text-align: center; width: 379px;" /></a><span style="font-size: 85%;">Real Electronic Medical Record screen of Mr. Sweet lacking warning banner, above; fictitious chart showing banner, below.<span style="color: red; font-style: italic; font-weight: bold;"> [Why wasn't it the fictitious patient chart that was fiddled with? - ed.]</span> <span style="font-weight: bold;">Click to enlarge.</span></span></div><br /><br />Such a warning apparently did <span style="font-weight: bold;">not</span> appear in Mr. Sweet's EMR chart, and that along with other failed communication (which can be read in the Motion) led to the re-intubation difficulties, and ultimately death. (I should note that it's possible the clinicians did flag the "difficult intubation" condition, but that the EHR lost the data through relational integrity problems, i.e., the information became "orphaned" from the patient's records, although still existing in the system somewhere.)<br /><br /><blockquote>(27) ... not one person knew that there was a note from anesthesiology containing a road map for success, that included the use of a "Fast-Track LMA device", neither of which was ever brought in for Mr. Sweet that night when he needed the tube to be put back in.<br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh2z4gOB0Q3lp2hrp57VVP_Ftbvf5LPbbQvUHMjDDu1mX33eJ8EiengqExqOgqRYD5ZMDuu_QwjIlW-r_0nEM5_2PsnWw-sGt9TK9jBUPZzbXIhYB6g4TsERT83SUa3nuPidqpgYhu2T7Hp/s1600/exhibit_E_how_banner_gets_there.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5656022205793766226" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh2z4gOB0Q3lp2hrp57VVP_Ftbvf5LPbbQvUHMjDDu1mX33eJ8EiengqExqOgqRYD5ZMDuu_QwjIlW-r_0nEM5_2PsnWw-sGt9TK9jBUPZzbXIhYB6g4TsERT83SUa3nuPidqpgYhu2T7Hp/s320/exhibit_E_how_banner_gets_there.jpg" style="cursor: pointer; display: block; height: 254px; margin: 0px auto 10px; text-align: center; width: 320px;" /></a><span style="font-size: 85%;"><span style="font-weight: normal;">Exhibit E. Under Oath. "A designation of difficult intubation automatically appears on a patient's banner bar if it is entered as a problem on the Problem List by the user selecting it from a drop-down menu list." <span style="font-style: italic;">(I tend to have doubts the problem list is that intelligent, but this is what was testified.)</span> <span style="font-weight: bold;">Click to enlarge.</span></span></span></div><br /><br />Sworn testimony indicates nobody took the appropriate actions to enable the alert to appear on the EMR screens:<br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEix2t2DuFqy6bgmlNvyHCD75TVDQxgRh3bEDxsbSjAjSTPB6W7bH1r-GzRLh6CCmB0iRTGYJ7EVUq70C7plb19dATP-Z1uqLc0VKTudlwi6R6jl8O3ohUU-ruV8wyeW01CvZnhakp5DwW2u/s1600/no_one_ordered_alert.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5656031663479819794" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEix2t2DuFqy6bgmlNvyHCD75TVDQxgRh3bEDxsbSjAjSTPB6W7bH1r-GzRLh6CCmB0iRTGYJ7EVUq70C7plb19dATP-Z1uqLc0VKTudlwi6R6jl8O3ohUU-ruV8wyeW01CvZnhakp5DwW2u/s320/no_one_ordered_alert.jpg" style="cursor: pointer; display: block; height: 231px; margin: 0px auto 10px; text-align: center; width: 326px;" /></a><span style="font-size: 85%;">Admitted under oath. Nobody did what it would take to make a "difficult intubation" alert appear on Mr. Sweet's chart.<span style="font-weight: bold;"> Click to enlarge.</span><br /></span></div><br />As a result of this missing data, the "syndrome of overconfidence in computers", and the toxic effect of poorly done health IT impairing clinician-clinician communications, physicians seeing this patient when he was under duress admit under oath they did not know of this intubation problem:<br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjJqIMyDrvvOYbOYgTR2iCeVPSBmx7qgbxzuBv3AN90MydUlouZIDByaCo-zMAazRMr6ApCuVu57Na1lGGVfh7U-jKTFixEFoUh0E-W9OmJB7aG8BB5u50dU0ryXhbPmIAQD4Hk_c_Znh6F/s1600/kaura_didn%2527t_know.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5656032339134827378" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjJqIMyDrvvOYbOYgTR2iCeVPSBmx7qgbxzuBv3AN90MydUlouZIDByaCo-zMAazRMr6ApCuVu57Na1lGGVfh7U-jKTFixEFoUh0E-W9OmJB7aG8BB5u50dU0ryXhbPmIAQD4Hk_c_Znh6F/s320/kaura_didn%2527t_know.jpg" style="cursor: pointer; display: block; height: 256px; margin: 0px auto 10px; text-align: center; width: 363px;" /></a><span style="font-size: 85%;">Dr. Kaura didn't know. <span style="font-weight: bold;">Click to enlarge.</span></span></div><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgbTxrAmyhpOQeGV7mPEdKXcMLBlI3Hk0uCJELiaUn752ZsI9DZzNAkeVrpjX3jy2JJT6WnBNGnAL_4_f5JbEV7fUIwos_upTAr1MZWH4g4C1VOzJpo93bAVUzw1OSuzJw1MdA3MR5C-nFR/s1600/sappington_didnt_know.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5656032394544316706" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgbTxrAmyhpOQeGV7mPEdKXcMLBlI3Hk0uCJELiaUn752ZsI9DZzNAkeVrpjX3jy2JJT6WnBNGnAL_4_f5JbEV7fUIwos_upTAr1MZWH4g4C1VOzJpo93bAVUzw1OSuzJw1MdA3MR5C-nFR/s320/sappington_didnt_know.jpg" style="cursor: pointer; display: block; height: 112px; margin: 0px auto 10px; text-align: center; width: 344px;" /></a><span style="font-size: 85%;">Dr. Sappington didn't know. <span style="font-weight: bold;">Click to enlarge.</span></span></div></blockquote><br />This is bad enough. The post-mortem chart fiddling issues I am addressing here begin with this:<br /><blockquote><br />C. (39) In the present case, after rounds of complex discovery battles, it became apparent that UPMC altered the records ... in this case, much of the record alteration was conducted by quality assurance officer, one Dr. Richard Simmons.<br /><br />(40) Once the brain death of Mr. Sweet was known, a wave of record alteration and supplementation occurred, largely though not exclusively at the behest of Dr. Simmons ...<br /><br />(41) For example, after Mr. Sweet was dead, when it could obviously not benefit his medical care, Dr. Simmons entered Mr. Sweet's computerized medical record, clearly looking into whether there had been a proper yellow-banner warning created through a problem list (which, of course, there was not). </blockquote><br />Again, these are serious charges. Why would the plaintiff attorney raise these charges? Let's look at some metadata:<br /><br /><blockquote style="font-weight: bold;"><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh9ry71dCSwp2Rt4JWNQ5UkIjlPIHVAiZDix555U1xxV52g2vf-tAtv2UvtKNySvIgOrvQmWRPz3yy2bNnAnLLKSderTTx9WNWEqnGwXR8ouK_MvUDDspG-TypMgdiHxpsqw34qeSfN130u/s1600/Exhibit_K_simmons_postmortem_gap_audit_trail.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5656353477734292466" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh9ry71dCSwp2Rt4JWNQ5UkIjlPIHVAiZDix555U1xxV52g2vf-tAtv2UvtKNySvIgOrvQmWRPz3yy2bNnAnLLKSderTTx9WNWEqnGwXR8ouK_MvUDDspG-TypMgdiHxpsqw34qeSfN130u/s320/Exhibit_K_simmons_postmortem_gap_audit_trail.jpg" style="cursor: pointer; display: block; height: 272px; margin: 0px auto 10px; text-align: center; width: 363px;" /></a><span style="font-size: 85%;"><span style="font-weight: normal;">Exhibit K, showing quality assurance officer Dr. Simmons fiddling with Mr. Sweet's chart on May 19th several times during the day, as well as on the 22nd. Note circled entries. <span style="font-weight: bold;">Note the gap</span> (labeled) and the time of the last entry on the 19th, 15:23. Also note all these dates are post mortem by several days; death was on the 16th. Also note the times of entry, and the part of the chart accessed in the second round of accesses on May 19th - including "problem list" at 15:02. <span style="font-weight: bold;">Click to enlarge. </span></span></span></div></blockquote><br />I note that we are left to wonder what happened between access round two by the QA Officer on May 19 beginning 15:01 PM, and round three on May 22 at 14:03 PM. (Where are data for May 19th after 15:23 and May 20th and 21st, I wonder as well? This was not a weekend but midweek ...)<br /><br />The Motion continues:<br /><br /><blockquote>(42) Thereafter, even though Mr. Sweet was now long dead and such action could do him no good, <span style="font-weight: bold;">Dr. Simmons tried to create a problem list</span> that had originally been omitted by Defendant. He listed a difficult airway as the problem (even though obviously Mr. Sweet's problem list would have included many things, such as having undergone an angiogram and a minor cerebral bleed). <span style="font-weight: bold;">In other words, Dr. Simmons tried to take the action necessary to make the computer show the yellow banner warning that was missing. </span></blockquote><br />Here's more metadata seemingly supporting this statement. It's clear that nobody, including especially someone in Dr. Simmons' role should have been doing ANYTHING to the data that would or could raise suspicion of alterations via the metadata, such as times. Surely a presumably competent senior physician in a peer review role would have known this.<br /><br />(I also note, <span style="color: #330033;"> </span><span style="color: #330033; font-weight: bold;">shouldn't the record have been electronically "locked" by several days after death</span>, thus causing <span style="font-weight: bold;">any </span>changes after the lock to appear in the normal "give us the legal medical record" outputs, not just in metadata?):<br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiXp5-CufdtW2vq7LB8vCaVfHom0JtTXDV4aQpAqfn9WpAwEh4uEHsJCT5GZRUll_IaBglaLLenJxJiiYFuMXZIYfEuHHqueKq7gggilXdJUmrS5VBRzhV3SWMAA20QxXpgKn0oiOp_tBY7/s1600/problem_history.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5656028439347558466" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiXp5-CufdtW2vq7LB8vCaVfHom0JtTXDV4aQpAqfn9WpAwEh4uEHsJCT5GZRUll_IaBglaLLenJxJiiYFuMXZIYfEuHHqueKq7gggilXdJUmrS5VBRzhV3SWMAA20QxXpgKn0oiOp_tBY7/s320/problem_history.jpg" style="cursor: pointer; display: block; height: 266px; margin: 0px auto 10px; text-align: center; width: 353px;" /></a><span style="font-size: 85%;">Exhibit L. Metadata showing Dr. Simmons on <span style="font-weight: bold;">May 19th </span>in the drop-down menu to make a problem list - then retracting it (<span style="font-style: italic;">"active --> cancelled"</span>) shortly afterwards. (I note the apparent cancellation time of 3:24 PM, i.e., 15:24,<span style="font-weight: bold;"> is just after the final May 19th entry of 15:23</span> on Exhibit K, when the several-day "gap" begins. I also note the patient died on <span style="font-weight: bold;">May 16th</span>. Curious... ) <span style="font-weight: bold;">Click to enlarge.</span></span></div><br />But problems apparently occurred:<br /><blockquote><br />(43) It did not work. The yellow banner would not appear retroactively onto the otherwise completed record although he did succeed in altering the original record to look like there had always been a problem list. Further, during review of the "detail sheets," the Plaintiff discovered that Dr. Simmons, having failed to create a banner warning, <span style="font-weight: bold;">tried to then delete or undo what he had attempted</span>, but could not get it out of the computer tracking system. See Exhibit L hereof. </blockquote><br />Let's look at the next part of Exhibit L:<span style="font-weight: bold;"><br /></span><span style="font-weight: bold;"><br /></span><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgaar_8PLLPXJLjGIzHH8Vm6yaDQ_dcQUYcVqGXQ32HqWFrGRq9qvujhEgYkCTpMluJRAYZw9G4BfyNajfWv5Y-43H7pOVC-FEmtX9nzkWWOQC_uzlq5WzqwyCLHrYtA2-I16YWUb1_CkiY/s1600/problem_list.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5656029408970613938" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgaar_8PLLPXJLjGIzHH8Vm6yaDQ_dcQUYcVqGXQ32HqWFrGRq9qvujhEgYkCTpMluJRAYZw9G4BfyNajfWv5Y-43H7pOVC-FEmtX9nzkWWOQC_uzlq5WzqwyCLHrYtA2-I16YWUb1_CkiY/s320/problem_list.jpg" style="cursor: pointer; display: block; height: 414px; margin: 0px auto 10px; text-align: center; width: 311px;" /></a><span style="font-size: 85%;"><span style="font-weight: bold;">Note the postmortem date of 5/19/2009 on this "problem list", and the attempted cancellation, presented as evidence.</span> </span><span style="font-size: 85%;"><span style="font-weight: bold;">Note the time of the Problem list addition - 3:02 PM (i.e., 15:02</span> as in exhibit K above). </span><span style="font-size: 85%;">Canceled as above at 3:24. Someone in Dr. Simmons' position should not have been fiddling with the problem list, knowing (or should have known, or should have made it his business to know) that footprints of fiddling in the metadata would, at the very least, <span style="font-style: italic;">raise eyebrows</span>. <span style="font-weight: bold;">Click to enlarge.</span></span></div><br />This does not look like the metadata that would be generated by peer review that I myself would perform ...<br /><br />In summary, this unique Motion containing actual EMR metadata is, in my personal view, suspect for 1) imprudent post-death fiddling with the EMR records at best, and/or 2) attempts to alter the EMR to unjustly protect those who caused harm to come to this patient at worst.<br /><br />I do not know which occurred, but hospital attorney Conti's excuse that "Dr. Simmons was in the medical record three days after Mr. Sweet died trying to figure out <span style="font-weight: bold;">how one would create a warning about a patient's difficult intubation</span>"<span style="color: red; font-style: italic; font-weight: bold;"> [that is, entering new data not present before - ed.]</span> could be either:<br /><br /><ul><li>A sign of lack of computer and legal savvy of a senior clinician/UPMC Presbyterian's head of quality assurance, but whose intentions were pure, as explained above; or</li><li>The confabulations of an attorney caught with his pants down.</li></ul><br />My personal opinion?<br /><br />Want to buy a bridge in Brooklyn, members of the jury and Your Honor?<br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiub9uKGChN-bDJ46C8KLfqBpWMWV6CdN9TlYfMpMyYp4Qox50KotMPgBYNpTjYAaGOtMYY8vagPv_yayC-bgcmQryqP2jxMMiABdM-ERAKVF72cDuUCVUVPaHzF0gRsLH3qPHe28asMV1Z/s1600/brooklyn-bridge.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5656030708798404066" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiub9uKGChN-bDJ46C8KLfqBpWMWV6CdN9TlYfMpMyYp4Qox50KotMPgBYNpTjYAaGOtMYY8vagPv_yayC-bgcmQryqP2jxMMiABdM-ERAKVF72cDuUCVUVPaHzF0gRsLH3qPHe28asMV1Z/s320/brooklyn-bridge.jpg" style="cursor: pointer; display: block; height: 210px; margin: 0px auto 10px; text-align: center; width: 280px;" /></a><span style="font-size: 85%;">NY bridge for sale. Cheap.</span></div><br /><br />The following also does not favorably influence my interpretation of the metadata:<br /><blockquote><br />(44) It is noteworthy that, prior to producing these results detail sheets that indicated such changes, UPMC attempted to file a motion for a protective order to bring all further discovery to a halt (a motion which was denied) even though the discovery deadline had not yet arrived. </blockquote><br />Obviously, this is not for me to decide and will need to await court adjudication, but as a Medical Informatics specialist and someone with some investigative experience regarding computers and medicine, I am not happy with the looks of this.<br /><br />I report, you decide.<br /><br />There were other allegations in this plaintiff's Motion, <span style="font-style: italic;">again based on clinical IT metadata</span>, regarding: unaccounted-for drugs of potential abuse (e.g., sedative <a href="http://en.wikipedia.org/wiki/Propofol">propofol</a>, the drug that <a href="http://www.foxnews.com/entertainment/2009/07/28/officials-believe-jacksons-doctor-gave-drug-killed-michael-jackson/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%25253A+foxnews%25252Fentertainment+%28FOXNews.com+-+Entertainment%29">killed Michael Jackson)</a>, the entry of fictitious data (such as vital signs, timing and medication administration by others including nurses), dictations coerced out of junior staff by senior personnel that might have been "spun" favorably to the medical center, etc., but those are the subject of later posts.<br /><br />I again repeat the six-month delay in this case could potentially leave various problems with this EMR system unexposed and unremediated. This could unnecessarily expose the public to six more months of risk.<br /><br /><b>Addendum:</b> if UPMC or the vendor take issue with posting of this material due to IP or other issues such as health IT gag clauses (which by the way are signed by hospital executives in violation of Joint Commission Safety Standards per my 2009 <a href="http://jama.ama-assn.org/content/302/4/382.1.extract">JAMA letter here</a> and longer essay <a href="http://hcrenewal.blogspot.com/2009/03/health-it-hold-harmless-and-defects-gag.html">here</a>), contact the Prothonotary Office in Pittsburgh, not me.<br /><br />-- SS<br /><br /><span style="font-size: 85%;"><span style="font-size: 100%;"><span style="font-weight: bold;">Addendum:</span></span><br /><br />What type of person was Mr. Sweet? This type:</span><br /><blockquote><span style="font-size: 85%;"><br /></span><span style="font-size: 85%;">Samuel E. Sweet Jr.</span><br /><span style="font-size: 85%;">Cheswick</span><br /><span style="font-size: 85%;"><br /></span><span style="font-size: 85%;">Samuel E. Sweet Jr., 62, of Cheswick, died Saturday, May 16, 2009, at UPMC Presbyterian Hospital. He was born Dec. 9, 1946, in New Kensington, son of the late Samuel E. Sweet Sr. and Marjorie (Secrist) Sweet. He was a resident of Cheswick for 33 years. He worked for the Army Corps of Engineers at Lock No. 2 of the Allegheny River and served in the Marine Corps during the Vietnam Era. He was a member of Hoboken Presbyterian Church, Blawnox Sportsmen Club, Blawnox "A" Club and the Springdale VFW. He enjoyed gardening and cutting grass. Survivors include his wife, Janet A. Sweet; sons, Samuel E. "Chip" (Michele) Sweet III, of Natrona, and William E. (Tracy) Sweet, of Edgewood; granddaughters, Kristin Ruff, of South Carolina, and Virginia Sweet, of Natrona; brother, John Thomas (Debbie) Sweet, of Warren; and nieces and nephews. Friends received from 2 to 6 p.m. Monday only, at the THOMAS M. SMITH FUNERAL HOME AND CREMATORY LTD., 930 Center Ave., Blawnox, followed by a funeral service at 7 p.m. in Hoboken Presbyterian Church, 921 North Ave., Blawnox, PA 15238. In lieu of flowers, the family respectfully suggests memorial contributions to Hoboken Presbyterian Church.<span style="font-style: italic;"><br /></span></span></blockquote>-- SS<br /><br style="font-weight: bold;" /><span style="font-weight: bold;">Addendum: </span><br /><br />This case <a href="https://dcr.alleghenycounty.us/DisplayImage.asp?gPDFOH=vol1089%20%20%20%20%20%20%20%20%20%20%20%20%20000002FF&CaseID=GD-09-019407&DocketType=PETOR&SeqNumber=79" target="_blank">was settled before going to trial</a> for <b>$1,375,000</b>.<br /><br />-- SS<br /><span style="font-size: 85%;"><span style="font-style: italic;"><br /></span></span>

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UPMC and the Sweet death that wasn't very sweet: How EMRs can detract from a clear narrative, and facilitate spoliation and obfuscation of evidence

The world of electronic medical records is very secretive.Vendors will not allow their programs or data structures to be examined, even by the academic community. Their products, medical devices…

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Law firms as enablers of HIT experiments? Familiar law firm now regular reader of Healthare Renewal

It continues to amaze me that unregulated, unvetted healthcare information technology of unproven benefit and proven harm continues to spread like wildfire. This occurs even when people are killed, such as the infant deaths I outlined <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">at this post</a> being defended by obstructionist law firms.<br /><br />This phenomenon has enablers. Among those, which include HIT vendors, their marketing arm HIMSS, large consultant companies, HIT pundits, the government, etc., law firms seem to have become enablers of hospitals' experiments with unproven, unqualified, unregulated healthcare information technology - in part by defending the medical mistakes that result.<br /><br />Lawyers defending blatant IT-related errors impede correction of the defects and impaired "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=ecosystem">HIT ecosystem</a>" that causes the problems. After all, they can simply tell a hospital a case is not defensible (and, for example, advise them to settle). Accepting cases is entirely voluntary.<br /><br />For example, take the law firm of MARSHALL,DENNEHEY,WARNER,COLEMAN defending the hospital that caused my mother's IT-related year-long suffering starting May 2010, and then death exactly one month ago on June 6, 2011. They have become a regular reader of Healthcare Renewal, and I can believe it's not to help the hospital improve its HIT.<br /><br />It's not as if lawyers are not writing on these issues, such as Case Western School of Law's <span style="font-size: small;">Sharona Hoffman in "</span><span style="font-size: small;"></span><a href="http://works.bepress.com/sharona_hoffman/7/" target="_blank">E-Health Hazards: Provider Liability and Electronic Health Record Systems</a>". That work is <span style="font-size: small;">a comprehensive analysis of the liability risks associated with use of clinical IT.</span><br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjCRFz75Cia3uR-_cGJZZq9m__nHNAo4hVOEyOr54_1QaPF9gbFpGYfe4kLCvicqhOKb4bhQoECn8f1A6x1wgIyPJTVDprUocf1_2xH79kbxSGMsc-0RdVkShYV7EY0UZG8CyljWVLUdpqT/s1600/coffin.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5626254650137511602" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjCRFz75Cia3uR-_cGJZZq9m__nHNAo4hVOEyOr54_1QaPF9gbFpGYfe4kLCvicqhOKb4bhQoECn8f1A6x1wgIyPJTVDprUocf1_2xH79kbxSGMsc-0RdVkShYV7EY0UZG8CyljWVLUdpqT/s320/coffin.jpg" style="cursor: pointer; display: block; height: 108px; margin: 0px auto 10px; text-align: center; width: 281px;" /></a><span style="font-size: x-small;">The real-world result of health IT interfering in simple care processes. Law firms that defend HIT-caused medical errors are enablers in use of these experimental technologies.</span></div><br />Perhaps they should have advised their clients of the risks of health IT <span style="font-style: italic;">before</span> my mother was maimed? Or did they not know of these risks, <span style="font-weight: bold;">something any law firm advising healthcare clients in 2010-2011 </span><a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">knew, should have known, or should have made it their business to know</a>?<br /><br />Some tracking examples among a larger set:<br /><br /><blockquote>Today:<br /><br />Domain Name (Unknown)<br /><span style="font-weight: bold;">IP Address 12.104.41.# (MARSHALL,DENNEHEY,WARNER,COLEMAN)</span><br />ISP AT&T WorldNet Services<br />Location<br />Continent : North America<br />Country : United States (Facts)<br />Language English (U.S.)<br />en-us<br />Operating System Macintosh WinNT<br />Browser Safari 1.3<br />Mozilla/5.0 (Windows NT 6.1) AppleWebKit/535.1 (KHTML, like Gecko) Chrome/13.0.782.41 Safari/535.1<br />Javascript version 1.5<br />Monitor<br />Resolution : 1280 x 1024<br />Color Depth : 32 bits<br />Time of Visit Jul 6 2011 10:08:54 am<br />Last Page View Jul 6 2011 10:30:45 am<br />Visit Length 21 minutes 51 seconds<br />Page Views 5<br />Referring URL <a href="http://www.google.com/search?sourceid=chrome&ie=UTF-8&q=there%27s%20also%20been%20a%20baby%20death%20locally%20to%20me%20that%20is%20allegedly%20due%20to%20HIT%20PACS%20interference%20in%20otherwise%20simple%20care">http://www.google.com/search?sourceid=chrome&ie=UTF-8&q=there%27s%20also%20been%20a%20baby%20death%20locally%20to%20me%20that%20is%20allegedly%20due%20to%20HIT%20PACS%20interference%20in%20otherwise%20simple%20care</a><br />Search Engine google.com<br />Search Words there's also been a baby death locally to me that is allegedly due to hit pacs interference in otherwise simple care<br />Visit Entry Page http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html<br />Visit Exit Page <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html</a><br />Out Click<br />Time Zone UTC-5:00<br /><span style="font-weight: bold;">Visitor's Time Jul 6 2011 10:08:54 am</span><br />Visit Number 902,836</blockquote><br /><blockquote>Yesterday:<br /><br />Domain Name (Unknown)<br /><span style="font-weight: bold;">IP Address 12.104.41.# (MARSHALL,DENNEHEY,WARNER,COLEMAN)</span><br />ISP AT&T WorldNet Services<br />Location<br />Continent : North America<br />Country : United States (Facts)<br />Language English (U.S.)<br />en-us<br />Operating System Macintosh WinNT<br />Browser Safari 1.3<br />Mozilla/5.0 (Windows NT 6.1) AppleWebKit/535.1 (KHTML, like Gecko) Chrome/13.0.782.41 Safari/535.1<br />Javascript version 1.5<br />Monitor Resolution : 1280 x 1024<br />Color Depth : 32 bits<br />Time of Visit Jul 5 2011 9:07:13 am<br />Last Page View Jul 5 2011 9:08:46 am<br />Visit Length 1 minute 33 seconds<br />Page Views 4<br />Referring URL h<a href="ttp://www.google.com/search?sourceid=chrome&ie=UTF-8&q=health%20care%20renewal">ttp://www.google.com/search?sourceid=chrome&ie=UTF-8&q=health%20care%20renewal</a><br />Search Engine google.com<br />Search Words health care renewal<br />Visit Entry Page <a href="http://hcrenewal.blogspot.com/">http://hcrenewal.blogspot.com/</a><br />Visit Exit Page <a href="http://hcrenewal.blogspot.com/2011/06/electronic-medication-prescribing-magic.html">http://hcrenewal.blogspot.com/2011/06/electronic-medication-prescribing-magic.html</a><br />Out Click<br />Time Zone UTC-5:00<br /><span style="font-weight: bold;">Visitor's Time Jul 5 2011 9:07:13 am</span><br />Visit Number 902,285</blockquote><br /><br />and an older one:<br /><br /><blockquote>Domain Name (Unknown)<br /><span style="font-weight: bold;">IP Address 12.104.41.# (MARSHALL,DENNEHEY,WARNER,COLEMAN)</span><br />ISP AT&T WorldNet Services<br />Location Continent : North America<br />Country : United States (Facts)<br />Language English (U.S.)<br />en-us<br />Operating System Macintosh WinNT<br />Browser Safari 1.3<br />Mozilla/5.0 (Windows NT 6.1) AppleWebKit/534.24 (KHTML, like Gecko) Chrome/11.0.696.28 Safari/534.24<br />Javascript version 1.5<br />Monitor Resolution : 1280 x 1024<br />Color Depth : 32 bits<br />Time of Visit Apr 4 2011 12:12:05 pm<br />Last Page View Apr 4 2011 12:33:44 pm<br />Visit Length 21 minutes 39 seconds<br />Page Views 30<br />Referring URL<br />Visit Entry Page <a href="http://hcrenewal.blogspot.com/">http://hcrenewal.blogspot.com/</a><br />Visit Exit Page <a href="http://hcrenewal.blogspot.com/2009/03/malpractices-of-multitudes-mission.html">http://hcrenewal.blogspot.com/2009/03/malpractices-of-multitudes-mission.html</a><br />Out Click<br />Time Zone UTC-5:00<br /><span style="font-weight: bold;">Visitor's Time Apr 4 2011 12:12:05 pm</span><br />Visit Number 860,621</blockquote><br />Note 30 page views in the latter data.<br /><br />-- SS

Law firms as enablers of HIT experiments? Familiar law firm now regular reader of Healthare Renewal

It continues to amaze me that unregulated, unvetted healthcare information technology of unproven benefit and proven harm continues to spread like wildfire. This occurs even when people are killed, su…

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Babies' deaths spotlight safety risks linked to computerized systems

<div>Two new tragic cases. (A third, earlier case of infant death was posted in March 2011 <a href="http://hcrenewal.blogspot.com/2011/03/thanks-to-wonders-of-ehr-this-premature.html">here</a>).<br /><br /><span style="font-weight: bold;">Case #1.</span> See <a href="http://www.chicagotribune.com/health/ct-met-technology-errors-20110627,0,5447654.story" style="font-weight: bold;">Baby's death spotlights safety risks linked to computerized systems</a> by Judith Graham and Cynthia Dizikes in the Chicago Tribune.<br /><br />A baby died at Advocate Lutheran General Hospital due to an intravenous solution containing a massive overdose of sodium chloride — more than 60 times the amount ordered by the physician. The authors write:<br /><br /><blockquote>Although a series of other errors contributed to the tragedy, its origin — <b>a piece of data entered inaccurately into a computer program</b> — throws a spotlight on safety risks associated with medicine's advance into the information age, a trend being pushed aggressively under health reform.<br /><br /></blockquote>One wonders if any type of alert was generated, and if not, why not.<br /><br /><span style="font-weight: bold;">Case #2.</span> There's also been a baby death locally to me that is allegedly due to HIT (PACS) interference in otherwise simple care processes.<br /><br />See "<span style="font-weight: bold;">Blake vs. Abington Memorial Hospital</span>" <a href="http://webapp.montcopa.org/PSI/Viewer/Detail.aspx?oq=aWQ9MjAwNzcwODI4JmVudGl0eT1DYXNl">at this link</a>. The Complaint in the latter case, a public document, is available as a .tif image at <a href="http://tinyurl.com/43qaqyr">this link</a> (1 MB; you may need to use IE to download beyond the first page).<br /><blockquote><span style="font-size: 85%;"><br /><span style="font-style: italic;">(</span><span style="font-style: italic; font-weight: bold;">July 8 addendum</span><span style="font-style: italic;">: since this blog post was published, I've noted multiple "hits" on it from the IP of the hospital involved, 65.216.195.x , at different times of the day, as well as on my Drexel website on HIT failure. Clearly they are aware of the issues noted herein.)</span></span><span style="font-size: 85%; font-style: italic; font-weight: bold;">(Sept. 2011 addendum:</span><span style="font-size: 85%; font-style: italic;"> the hospital has now filed a </span><span style="font-size: 85%; font-style: italic;">Motion to Compel Settlement</span><span style="font-size: 85%; font-style: italic;"> that can be seen as item #67 and downloaded from the aforementioned courts dockets page <a href="http://webapp.montcopa.org/PSI/Viewer/Detail.aspx?oq=aWQ9MjAwNzcwODI4JmVudGl0eT1DYXNl">here</a>.)</span></blockquote><br />A critical x-ray of a PICC (<a href="http://en.wikipedia.org/wiki/Peripherally_inserted_central_catheter"><span style="font-style: italic;">peripherally inserted central catheter</span></a>) line placement allegedly was never read due to misdating. See for example counts 17 - 25, and 39 - 45. It was dated several days earlier than it was taken.<br /><br />Counts 39-49 (emphases mine):<br /><br /><blockquote>39. Defendants also described that the February 27, 2010, x-ray was digitally transmitted to radiology, and the technician attempted to match the image to doctors’ orders, and then put all the identifying information on the film, including the patient’s name, date of birth and date of study.<br /><br />40. Defendants told Plaintiffs that the radiology technician picked the wrong name and put it on the x-ray, and then later realized it was the wrong name and then somehow changed the information on the image.<br /><br />41. Defendants told Plaintiffs <span style="font-weight: bold;">w</span><span style="font-weight: bold;">hen the technician changed the information on the image, she typed the date of birth where she should have typed the date of study</span>. <span style="color: red; font-style: italic; font-weight: bold;">[Puzzling; my $99 Canon camera embeds date information in the image itself, as do PACS systems - ed.]</span><br /><br />42. Defendants told Plaintiffs that the <span style="font-weight: bold;">incorrect date on the image caused the x-ray not to be read by a radiologist in the night the image was taken</span>, 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, <span style="font-weight: bold;">the film was classified as “old” and was not put in line for immediate review</span>, and was not reviewed in time to prevent injury to Plaintiffs Decedent.<br /><br />43. The Defendants told Plaintiffs that an <span style="font-weight: bold;">older x-ray has less significance than a newer image and is, therefore, not as critical to review</span>. <span style="color: red; font-style: italic; font-weight: bold;"> [This is exactly the reverse of good radiological practice. 'Old' - but never officially read - means 'potential danger' such as missed findings of importance, subtle or gross findings that could alter the interpretation of later films, etc. - ed.]</span><br /><br />44. The Defendants told Plaintiffs that the x-ray was reviewed by Dr. Griffith on the morning of February 28, 2010. At that time, Dr. Griffith, thinking that the image was from the 23rd, compared it to the next most recent image, which was from the 25th In reviewing these x-rays, <span style="font-weight: bold;">D</span><span style="font-weight: bold;">r. Griffith reportedly concluded that the PICC line shown in the image she believed was from the 23rd had been removed by the 25th. <span style="color: red; font-style: italic;">[Gevalt - what a tragic error. In healthcare, critical attention to detail at all times is required, or your patient's dead. There is no room for computer fritter. - ed.]</span></span><br /><br />45. Defendants told Plaintiff that the x-ray from the 27th, which was mislabeled as being from the 23rd, would have been reviewed by the neonatologist on duty on the morning of the 28th, but <span style="font-weight: bold;">this did not happen because the computer which places films in line to be reviewed would have ignored such an “old” film</span>. <span style="color: red; font-style: italic; font-weight: bold;"><br /><br />[Note the accusation of the computer making a decision on what clinicians should and should not look at, thereby acting as cybernetic 'governor' or 'conductor' of care. The machine or, more properly, the algorithms created by its programmers, decided what the humans should or should not look at. This is not uncommon in HIT. Yet, who qualified these machines and their code to play this role? More on this critical issue</span> <span style="font-style: italic;"><a href="http://hcrenewal.blogspot.com/2011/06/electronic-medication-prescribing-magic.html">at this link</a>.</span> <span style="color: red; font-style: italic; font-weight: bold;">- ed.]</span><br /><br />46. The Defendants told Plaintiffs that the next 24 hours were uneventful, but late in the day on Monday May 1, 2010, Destinee’s condition began to deteriorate rapidly.<br /><br />47. The Defendants told the Plaintiffs that the during the efforts to reverse Destinee’s deterioration, they discovered that the PICC line was in the wrong position, and that they confirmed this by sampling the fluid from around the heart, which was found to be full of hyperalimentation fluid, and then pulled the line back from its incorrect and dangerous position in the heart.<br /><br />48. The Defendants told Plaintiffs that they did not know if the PICC line <span style="font-weight: bold;">caused a hole in the heart, but that just having the line in the heart was enough for it to push the hyperalimentation fluid into the pericardium. </span><br /><br />49. As a direct and proximate result of Defendants’ negligence, Plaintiff’s Decedent’s suffered injuries, including but not limited to: <span style="color: red; font-style: italic; font-weight: bold;">[numerous catastrophic complications followed by death - ed.]</span></blockquote><br />If these counts are accurate, I ask the same question as in case #1: if an x-ray was accidentally dated five days or so before it was taken (how can that even happen?), why was an alert not triggered that an "old" (and unread) x-ray needed an official radiologist reading ASAP?<span style="font-weight: bold;"></span><br /><br />What are hospitals getting for their <a href="http://hcrenewal.blogspot.com/2006/10/70-million-for-electronic-medical.html">tens to hundreds of millions of dollars</a> they are throwing at clinical IT?<br /><br />This latter story really disappoints me if true. I was a Resident in Internal Medicine in this hospital in the mid 1980's and used my knowledge of radiology, in which I spent a year of formal postdoctoral education, and of computing to fix a CT scanner in the middle of the night and save a young man's life (as documented in a letter from my former Residency Director, now the Chief of Staff <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/references/jk1.jpg">here</a> and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/references/jk2.jpg">here</a> , pgs. 1 and 2 respectively).<br /><br />Ironically, even after all these years, I probably could have read that PICC line placement x-ray.<br /><br /><b>(Note:  more on the x-ray foul up in the Phila. Inquirer</b> <a href="http://articles.philly.com/2011-11-06/news/30366671_1_catheter-vein-heart-wall" target="_blank">here</a>.  "<b>Use error</b>" - per NIST, bad IT design that promotes mistakes, as opposed to "<b>user error</b>" i.e., simple carelessness - seems a factor.)<br /><br />Technology can be a great blessing in medicine. I am alive and healthy in 2011 thanks to it. The medical condition referred to in the aforementioned letter was in fact cured as a result of advances in cardiac electrophysiology science, as<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/scotsilv/batsford1.jpg"> here</a> and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/scotsilv/batsford2.jpg">here</a>, pgs. 1 and 2).<br /><br />However, technology cannot be applied cavalierly, lawlessly (per attorney Sharona Hoffman), experimentally, without regulation, and without informed patient consent as is often done in the world of HIT.<br /><br />-- SS<br /><br /><b>Feb. 29, 2012 Addendum:</b> the Allen-Blake case was <a href="http://webapp.montcopa.org/PSI/Viewer/Detail.aspx?oq=aWQ9MjAwNzcwODI4JmVudGl0eT1DYXNl">settled</a> 2/29/12 for $1.5 million:<br /><br /><table border="1" cellspacing="0" class="ChamaeleonGrid" rules="all"><tbody><tr class="GridItem"><td>2/29/2012</td><td>Order</td><td>OF 2/28/12 OTT, J PROPOSED SETTLEMENT OF <span style="font-weight: bold;">$1,500,000.00 </span>APPROVED CC </td></tr></tbody></table><br />This will not, of course, bring the baby back.  Also, I certainly wonder if this is looked at by some as a cost of doing 'EHR business.'<span style="font-weight: bold;"><br /></span><br /><br /><span style="font-weight: bold;">June 27, 2011 addendum:</span><br /><br />In further review of the <a href="http://webapp.montcopa.org/PSI/Viewer/Detail.aspx?oq=aWQ9MjAwNzcwODI4JmVudGl0eT1DYXNl">dockets</a> in case #2, I find there seems to be a wee problem getting the hospital's Chief of Staff Jack Kelly to a deposition.<br /><br />In a motion filed June 10, 2011 by the plaintiffs, "BY ADMINISTRATOR ERICA L ALLEN-BLAKE; RICARDO BLAKE; ESTATE OF DESTINEE LOTOYA BLAKE DECEASED MOTION TO COMPEL DEPOSITION OF DR. JACK KELLY" (.tif file at <a href="http://tinyurl.com/4xvr6wt">this link</a>), in Exhibit "J" the plaintiff's attorney writes to the defendants' attorney (emphases mine):<br /><br /><blockquote>I received your faxed letter of May 2, 2011. <span style="font-weight: bold;">I don’t agree with any of your sophistry, and want to depose<span style="color: red; font-style: italic;"> [Chief of Staff]</span> Dr. Kelly</span>. I remind you that you objected to the Complaint, claiming the meeting with the Plaintiffs had a specific purpose under MCARE (which never made any sense, but you wrote it, not me). Your objection raised issues of fact. If you don’t want to back them up, or can’t, then withdraw the objections.<br /><br />If you’d like to ask the Plaintiffs one question at a deposition taken pursuant to your pending objections - i.e., whether they were told by your clients that MCARE written notice was purpose of the meeting or not - I’d agree to let you do that. <span style="font-weight: bold;">I can represent to you that their answer will be "no.”</span><br /><br />Be advised that I am tired of Abington’s dilatory tactics in this clear liability case in which an infant was killed by, among other things, <span style="font-weight: bold;">s</span><span style="font-weight: bold;">ome of the most egregious professional malpractice imaginable. </span>On top of that, Abington refused to provide the name of the radiology technician until suit was filed. <span style="font-weight: bold;">Now, you’re playing ticky-tack games about depositions</span>, and my clients are understandably not impressed.<br /><br />Under cover of separate letter you will find a Notice of Deposition for Dr. Kelly for this Friday, May 6, at 2 pm in my offices. </blockquote><br />Wow.<br /><br />A motion to compel was filed on 6/22/2011 so apparently the May 6 deposition did not take place.<br /><br />I add the the MCARE Act of 2002 ("MEDICAL CARE AVAILABILITY AND REDUCTION OF ERROR ACT") in Pennsylvania (PDF at <a href="http://www.portal.state.pa.us/portal/server.pt/document/495911/hb1802_pdf">this link</a>) states:<br /><br /><blockquote><span style="font-weight: bold;">MCARE Section 308. Reporting and notification.</span><br /><br />... B. Duty to notify patient.--A medical facility through an appropriate designee <span style="font-weight: bold;">shall </span><span style="font-weight: bold;">provide written notification</span> <span style="color: red; font-style: italic; font-weight: bold;">['written' - this word would appear to mean "in writing" - ed.] </span>to a patient affected by a serious event or, with the consent of the patient, to an available family member or designee within seven days of the occurrence or discovery of a serious event. If the patient is unable to give consent, the notification shall be given to an adult member of the immediate family. If an adult member of the immediate family cannot be identified or located, notification shall be given to the closest adult family member.</blockquote><br />Allegedly from the June 10 Plaintiff's Motion, as it appears to me, the hospital seems to be trying to claim a verbal meeting with the family satisfied the MCARE Act's notification requirements even though nothing in writing was apparently given, but that the information exchanged in that family meeting is not admissible in court.<br /><br />It seems hospitals (perhaps pushed by their insurers) attempt to play legal games to try to avoid culpability for their "computer-anecdote" patients, some who end up as roadkill on the experimental racetrack of health IT.<br /><br />Again, this is doubly disappointing if accurate, as I knew some of the principals on the defendants' side two and a half decades ago.<br /><br />Also see a third case at my aforementioned March 2011 post "<span style="font-weight: bold;">Thanks to the wonders of EHR, this premature baby went to the grave, prematurely</span>" <a href="http://hcrenewal.blogspot.com/2011/03/thanks-to-wonders-of-ehr-this-premature.html">at this link</a>, from an Oct. 2010 story in <span style="font-style: italic;">Virginia Lawyers Weekly </span>("Failures in care alleged after premature birth - $1,000,000 Settlement"). A PICC line was also involved.<br /><br />-- SS </div>

Babies' deaths spotlight safety risks linked to computerized systems

Two new tragic cases. (A third, earlier case of infant death was posted in March 2011 here).Case #1. See Baby's death spotlights safety risks linked to computerized systems by Judith Graham and Cynt…

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My mother passed away

My mother, affected catastrophically by an EHR-related medical error last year, passed away yesterday evening.<br /><br />In her memory, a photo of her and me from 1957 I found in her possessions.<br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiv-E3wO13rdXP7VzcB7xfF8bJSRNCs87Mpc9QmZglwi3woZ1SilAhwXpRhBzAWW1SFZQRMaXwxfvUMb2zF0p37acBz7lo60qbCd8ezupYmhR9b8zvSsZHODJLGQ5hOX_wCj3_E7Fx7kwit/s1600/mom_scot_nov_1957.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5615469594730285570" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiv-E3wO13rdXP7VzcB7xfF8bJSRNCs87Mpc9QmZglwi3woZ1SilAhwXpRhBzAWW1SFZQRMaXwxfvUMb2zF0p37acBz7lo60qbCd8ezupYmhR9b8zvSsZHODJLGQ5hOX_wCj3_E7Fx7kwit/s320/mom_scot_nov_1957.jpg" style="cursor: pointer; display: block; height: 214px; margin: 0px auto 10px; text-align: center; width: 209px;" /></a><span style="font-size: 85%;">Betty Silverstein, 1925-2011</span></div><br />Her children were always Number One.<br /><br />May she rest in peace, and may my efforts result in others not having to suffer similar mistakes at the hands of IT.<br /><br />-- SS<br /><br /><span style="color: black; font-size: 100%;"><span style="font-family: arial;"><span style="font-weight: bold;">Nov. 2011 addendum:</span><br /><br />Here is a memorial bench I had erected for my parents at their grave last month, near where they ran a small community pharmacy for almost four decades. </span></span><span style="color: black; font-size: 100%;"><span style="font-family: arial;">My father, a pharmacist, was a go-to source for health information in the <a href="http://articles.philly.com/1986-03-25/business/26081235_1_kelsey-hayes-city-material-manufacturer/2">once-bucolic</a> community of Somerton, in far Northeast Philadelphia, long before chain drugstores appeared in the region.<br /></span></span><span style="color: black; font-size: 100%;"><span style="font-family: arial;">The inscription atop the bench reads "Owners of Lumar Pharmacy. Served This Community 1954 -1991."<br /><br />They, like I, also toiled to safeguard and improve the health of the public.<br /></span></span><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjcv16diXLcbUohXLgr0_aYm9nSQGQC35iuw6azshW7cz6uh1YPqAYRMECSlFEYvf6UC5aicbz0diRKK6vlYVcKWEMxz2H6gmTREMs_mCjOHcv3PoWMOmrLXH7SGL81Ny9rI9r01qVQiYLg/s1600/Bench.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5676763765660102866" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjcv16diXLcbUohXLgr0_aYm9nSQGQC35iuw6azshW7cz6uh1YPqAYRMECSlFEYvf6UC5aicbz0diRKK6vlYVcKWEMxz2H6gmTREMs_mCjOHcv3PoWMOmrLXH7SGL81Ny9rI9r01qVQiYLg/s320/Bench.jpg" style="cursor: pointer; display: block; height: 200px; margin: 0px auto 10px; text-align: center; width: 267px;" /></a><span style="font-size: 85%;">Click to enlarge</span></div><br /><span style="color: black; font-size: 100%;"><span style="font-family: arial;">May they rest in peace.<br /><br />-- SS</span></span>

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My mother passed away

My mother, affected catastrophically by an EHR-related medical error last year, passed away yesterday evening.In her memory, a photo of her and me from 1957 I found in her possessions.Betty Silverstei…

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FDA MAUDE Database: Patient Outcome - Death

I present another health IT problem case from the FDA's voluntary <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm">MAUDE</a> (<span style="font-weight: bold;">Manufacturer and User Facility Device Experience</span>) database below.<br /><br />From FDA's description of MAUDE:<br /><br /><ul style="font-style: italic;"><li>MAUDE data represents reports of adverse events involving medical devices. The data consists of <span style="font-weight: bold;">voluntary reports</span> since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19. </li><li>The on-line search allows you to search CDRH database information on medical devices which may have malfunctioned or caused a death or serious injury. MAUDE is scheduled to be updated monthly and the search page reflects the date of the most recent update. FDA seeks to include all reports received prior to the update. However, the inclusion of some reports may be delayed by technical or clerical difficulties.</li><li>MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. Please be aware that reports regarding device trade names may have been submitted under different manufacturer names. Searches only retrieve records that contain the search term(s) provided by the requester. </li></ul><br />I somehow missed the following case when I wrote the Oct. 2009 post <span style="font-weight: bold;">'</span><a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2009/10/out-policy-is-to-always-have-unabashed.html">Our Policy Is To Always Have Unabashed Faith In The Computer ... Except When It Screws Up, And Then It's The Doctor's Fault</a><span style="font-weight: bold;">'</span> but I have added it there as well:<br /><blockquote><br /><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656460">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656460</a><br /><strong><span style="font-weight: normal;">CERNER MILLENIUM POWERCHART CPOE </span><br /><span style="font-weight: normal;">Event Date 11/19/2006 </span><br /><span style="font-weight: bold;">Event Type: Death </span><br /><span style="font-weight: bold;">Patient Outcome: Death<br /><br /></span></strong>The medication review screen of the subject device does not specify the exact dose in milligrams of combination medications. For example, narcotics are combined with tylenol in at least two strengths. Liquid narcotic tylenol-oxycodone combination is reported in ml, not mg. The exact dose of tylenol is not specified and requires knowledge of the combination medication dose in the volume specified.<br /><br />Certain fields of the grid do not specify the volume, but rather state "date/time" requiring another click or pop up screen. The immediate knowledge of tylenol dosage in mg is directly related to understanding and preventing excessive doses. In the subject, 10 ml of acetaminophen-oxycodone is indicated as having been given 3 times over 4 hours. That means that 1950 mg of tylenol was administered in 4 hours while the patient was in a state of starvation and receiving other medication that increase the effects of tylenol.<br /><br />This dose would equate to 11,700 mg of tylenol over 24 hours, nearly 3 times the maximum daily dose in otherwise health people. In the ensuing days, the patient developed acute renal failure, presumably acute tubular necrosis, and died. In the absence of other etiology, the excess tylenol was the culprit. This was not considered as etiology ante-mortem. The counterintuitive screen impaired the professionals. The pharmacist did not recognize and stop the medication, the nurses administered it, and the excessive dose, <span style="font-weight: bold;">clinically meaninglessly listed as a volume of 10 ml -given 3 times in 4 hours- of acetaminophen-oxycodone</span>, was missed by the physicians. Adverse events have been ascribed to "user error" by vendors. <span style="font-weight: bold;"><br /><br />The device offers a potent propensity to life endangering oversights. There are other screens on this device which present information that interfere with clinically useful visualization of data. </span><span style="font-style: italic; font-weight: bold; color: rgb(255, 0, 0);">[Who designed these screens, I ask? Clinicians, or business IT personnel used to designing inventory systems for widget control? - ed.]</span> The data does not flow to the professionals. It is not represented in a meaningfully useful manner.<br /><br />The professionals need to hunt for it. As such, the <span style="font-weight: bold;">user unfriendly screens</span> <span style="font-weight: bold; font-style: italic;"><span style="color: rgb(255, 0, 0);">[see </span><a href="http://www.tinyurl.com/hostileuserexper">this link</a> <span style="color: rgb(255, 0, 0);">on mission hostile HIT - ed.]</span></span><span style="color: rgb(255, 0, 0);"> </span>impair safe medical care consistent with the impediment to expedient professional understanding of what, exactly, is the dose of medication and how much was administered to the patient. This sentinel case of death is directly attributed to user unfriendly screens on this device.</blockquote><br />How many cases like this, as well as "near misses" related to health IT go unreported, nationwide and worldwide? <span><br /><br />As in my paper "<a href="http://www.scribd.com/doc/28747771/Remediating-an-Unintended-Consequence-of-Healthcare-IT-A-Dearth-of-Data-on-Unintended-Consequences-of-Healthcare-IT">Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT</a>",</span><span style="font-weight: bold;"> nobody really knows; these devices are unregulated </span><span>with no requirements for reporting.</span><br /><br />However, let's roll it out nationally anyway, because HIT will deterministically "revolutionize" medicine. Just ignore those spoil-the-party, man-behind-the-curtain prattle from writers <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">like these</a>.<br /><br />We can safely ignore all contrarian research and literature, of course, as we all know HIT will revolutionize medicine from the definitive certainty of HHS in <span style="font-size:100%;">"<a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html"><span style="font-weight: bold;">The 'Meaningful Use' Regulation for Electronic Health Records</span></a>", NEJM, Blumenthal and </span><span style="font-size:100%;">Tavenner (10.1056/NEJMp1006114, July 13, 2010)</span>:<br /><br /><span style="font-size:100%;"></span><blockquote><span style="font-size:100%;">The widespread use of electronic health records (EHRs) in the United States <span style="font-weight: bold;">is inevitable</span>. EHRs <strong>will</strong> improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they <strong>will demand</strong> nothing less from their providers. Hundreds of thousands of physicians have <strong>already seen these benefits</strong> in their clinical practice. <span style="font-weight: bold; font-style: italic;"><span style="color: rgb(255, 0, 0);"><br /><br />[Except for those who</span> <a href="http://archinte.ama-assn.org/cgi/content/short/167/13/1400">haven't</a> <span style="color: rgb(255, 0, 0);">- ed.]</span></span><br /></span></blockquote><br />And our government's called <a href="http://www.bp.com/sectiongenericarticle.do?categoryId=3&contentId=2006926">BP Energy Company</a> cavalier?<br /><br />I offer no additional comments.<br /><br />-- SS

FDA MAUDE Database: Patient Outcome - Death

I present another health IT problem case from the FDA's voluntary MAUDE (Manufacturer and User Facility Device Experience) database below.From FDA's description of MAUDE:MAUDE data represents reports …

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