Yet another EHR "glitch" - insulin decreased per protocol, oops, I meant heparin

Yet another EHR "glitch" (<a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a>):<br /><br /><blockquote class="tr_bq"><a href="http://www.labornotes.org/2013/07/electronic-medical-records-friend-or-foe">http://www.labornotes.org/2013/07/electronic-medical-records-friend-or-foe</a><br /><br />An emergency room nurse described her frustrating experience trying to accurately document a dose of <b>heparin</b>, a blood thinner for patients with chest pain. “The doctor stated he wanted 4000 units bolus [all at once] and then a 1000 unit per hour infusion,” she wrote. “The order in Paragon stated 5000 units of <u><b>heparin</b></u>. I was given the option to decrease the dose, which I manually changed.<br /><br />“However, I had to pick a reason why I decreased the dose. There was a drop-down box, and the only option was <b>‘<u>Insulin</u> decreased per protocol.’”</b></blockquote><br />In the unregulated world of health IT, there's no pre-market evaluation or QC process to find little "glitches" like this that make it onto floors of live patients.  <br /><blockquote class="tr_bq"><br />The drug was heparin, not insulin. What was she supposed to do? “I contacted the pharmacy and spoke to three different people, and the final response was,<b> ‘snapshot the screen and give it to your manager.’ </b>This was a nine-minute conversation.”</blockquote><br />That's really not very helpful to the patient needing heparin urgently.<br /><blockquote class="tr_bq"><br />The manager finally advised her to <i>select the given option for insulin</i>, <b>then separately document that heparin, not insulin, was given.</b></blockquote><br />No future mistakes are possible due to this little glitch "workaround", right?<br /><br /><blockquote class="tr_bq">That’s <b>nine extra minutes away from the bedside</b>, just to document one medication—<b>and to document it inaccurately, to boot.</b> Multiply that times the many different tasks and patients a nurse juggles every day, and you start to see the problem. </blockquote><br />I point out that this order would have taken exactly ten seconds with a pen and paper.<br /><br />I hear stories like this - odd "glitches" and "gotchas" - from medical colleagues at least weekly, and sometimes daily. <br /><br />-- SS

Yet another EHR "glitch" - insulin decreased per protocol, oops, I meant heparin

Yet another EHR "glitch" (http://hcrenewal.blogspot.com/search/label/glitch):http://www.labornotes.org/2013/07/electronic-medical-records-friend-or-foeAn emergency room nurse described her frustrating…

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Cerner: "It’s in the DNA of our company to have the vision and passion to fix what’s broken in health care." Maybe they should fix their software first?

I point out this hyper-exuberant piece on health IT in the St. Louis Post-Dispatch.<br /><br />Clearly someone at Cerner thinks they're going to cure the world with "population health" and their computer software:<br /><br /><blockquote class="tr_bq"><b>With its Healthy Nevada initiative, Cerner Corp. cultivates a culture of health</b><br />St. Louis Post-Dispatch<br />Diane Stafford,  Kansas City Star<br />May 11, 2014<br /><br /><a href="http://www.stltoday.com/news/special-reports/mohealth/updates/with-its-healthy-nevada-initiative-cerner-corp-cultivates-a-culture/article_8cc3168f-fd9f-5e7e-ba80-cc05dd6a35f9.html">http://www.stltoday.com/news/special-reports/mohealth/updates/with-its-healthy-nevada-initiative-cerner-corp-cultivates-a-culture/article_8cc3168f-fd9f-5e7e-ba80-cc05dd6a35f9.html</a><br /><br />Cerner Corp. employees started visiting Nevada, Mo., in 2011, looking to adopt a community as a testing ground for theories to control skyrocketing medical costs.<br /><br />At the outset, “our discussions were marked by a lot of confusion,” recalled City Manager John David Kehrman. “We thought of Cerner as a data company. We didn’t understand what they wanted.”<br /><br />The North Kansas City-based company, grown to global prominence by selling health care information technology to hospitals and doctors, aimed to reach a broader audience with a message: You have to take more responsibility for your own health.<br /><br />... the company’s bigger evolution is that it’s investing millions in its next-generation software, dubbed Healthe Intent, which tracks individual and group health and treatment results. It re-imagines jobs in the health care industry and eventually will reach into patients’ homes.<br /><br />If the initiatives blossom, Cerner executives believe they will boost the company’s revenue by billions of dollars a year ... <b>“Cerner’s founders never saw themselves being a health care IT company</b>,” Swindells asserted.<b> “They saw themselves fixing health care.”</b></blockquote><br />Wow.  That's a neat trick for a health IT company.<br /><br />(As I asked of health IT company CEOs making similar statements back at a 1997-or-so Microsoft Healthcare Users Group meeting, "How are you going to revolutionize healthcare when you and nearly everyone at this meeting has no actual healthcare experience?"  They had no rational answer.  See "<b>Broken Chord</b>", Healthcare Informatics, Feb. 1999, archived <a href="https://web.archive.org/web/19991005222815/http://www.healthcare-informatics.com/issues/1999/02_99/postmark.htm">at this link</a>.)<br /><br />I won't comment further on the content of the St. Louis Post-Dispatch piece, which is marketing agitprop.  It's their right to produce such material, after all.  Read it for yourself and learn of our glorious Cerner-driven health utopia.<br /><br />I will comment, however, on one line in the piece, namely:<br /><br /><blockquote class="tr_bq">... “<b>It’s in the DNA of our company to have the vision and passion to fix what’s broken in health care</b>,” said Matthew Swindells, Cerner’s head of population health and global strategy. </blockquote><br />Considering the broken health IT this company introduces into the market upon unsuspecting physicians, nurses and patients [e.g., see notes 1-6], perhaps they should consider fixing <b>what's broken in health IT</b> before releasing to market, and certainly before attempting to tackle the <i>infinitely harder task</i> of "fixing what's broken in health care."<br /><br />-- SS<br /><br />Notes: <br /><br /><span style="font-size: x-small;">[1]  November 17, 2013. "<b>Another 'Survey' on EHRs - Affinity Medical Center Nurses Warn That Serious Patient Complications 'Only a Matter of Time' in Open Letter</b>", <a href="http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html">http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html</a></span><br /><span style="font-size: x-small;">  </span><br /><span style="font-size: x-small;">[2] January 19, 2012. "<b>[British MP] Bacon calls for halt on [Cerner] Millennium</b>", <a href="http://www.ehi.co.uk/news/acute-care/7471/bacon-calls-for-halt-on-millennium">http://www.ehi.co.uk/news/acute-care/7471/bacon-calls-for-halt-on-millennium</a></span><br /><br /><span style="font-size: x-small;">[3]  January 21, 2011.  "<b>MAUDE and HIT Risks: What in God's Name is Going on Here?</b> [Cerner health IT defects reports]", <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html</a></span><br /><span style="font-size: x-small;"><br /></span><span style="font-size: x-small;">[4]  March 4, 2011. <b>"A study of an Enterprise Health information System </b>[Cerner Firstnet]<b>"</b>,<b> </b>Prof. Jon Patrick, Univ. of Sydney, <a href="http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146">http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146</a></span><br /><br /><span style="font-size: x-small;">[5] Oct. 20, 2010.  "<b>Medical center has more than 6000 "issues" with Cerner CPOE system in four months</b>", <a href="http://hcrenewal.blogspot.com/2010/10/medical-center-has-more-than-6000.html">http://hcrenewal.blogspot.com/2010/10/medical-center-has-more-than-6000.html</a> </span><br /><br /><span style="font-size: x-small;">[6] 2009.  "<b>The National Programme for IT in the NHS: Progress since 2006 - Public Accounts Committee</b>" [on Lorenzo and Cerner Millenium], UK National Programme for Health IT in the NHS (now defunct), <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm</a></span><br /><br /><br /><span class="Apple-style-span" style="font-size: x-small;"></span>

Cerner: "It’s in the DNA of our company to have the vision and passion to fix what’s broken in health care." Maybe they should fix their software first?

I point out this hyper-exuberant piece on health IT in the St. Louis Post-Dispatch.Clearly someone at Cerner thinks they're going to cure the world with "population health" and their computer software…

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EHR recall: Use of this affected product may cause serious adverse health consequences, including death

Here is another example of a grossly defective health IT product, this from last year but only posted by FDA publicly on 3/14/2014 at <a href="http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm389356.htm">http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm389356.htm</a><a href="http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm389328.htm" target="_blank"></a>:<i> </i><br /><br /><i>"There was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR) in that it included data from another case. <b>Use of this affected product may cause serious adverse health consequences, including death."</b></i><b></b><br /><br />One wonders why problems like this are found in the field when real patients are involved, not in the testing lab...could it have to do with lack of regulatory oversight?<br /><br />Other examples of recalled bad health IT that I know of, including FDA-initiated recalls, are here:  <a href="http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2012/07/health-it-fda-recall-<wbr></wbr>philips-xcelera.html</a>, <a href="http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2011/12/fda-recalls-health-it-<wbr></wbr>software-because.html</a> , <a href="http://hcrenewal.blogspot.com/2013/08/a-good-way-to-cynernetically-harm-or.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2013/08/a-good-way-to-<wbr></wbr>cynernetically-harm-or.html</a>. <br /><br />Also note the FDA advisory:  <b>Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to <a href="https://www.accessdata.fda.gov/scripts/medwatch/" target="_blank">MedWatch: The FDA Safety Information and Adverse Event Reporting Program</a> either online, by regular mail or by FAX:</b><br /><div><br /><blockquote class="tr_bq"><a href="http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm389328.htm" target="_blank">http://www.fda.gov/<wbr></wbr>MedicalDevices/Safety/<wbr></wbr>ListofRecalls/ucm389328.htm</a><b> </b><br /><br /><b>McKesson Technologies, McKesson Anesthesia Care – Patient Case Data May Not Match Patient Data</b><br /><br /><b>Recall Class:</b> Class I<b> </b><br /><br /><b>Date Recall Initiated</b>: March 15, 2013<b> </b><br /><br /><b>Product:</b> McKesson Anesthesia Care<b> </b><br /><br /><b>Use:</b> The device is a computer-based system which collects, processes, and records data both through manual entry and from monitors which are attached to patients, such as in an operating room environment. The system provides clinical decision support by communicating potential adverse drug event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care.<b> </b><br /><br /><b>Recalling Firm:<br /></b>McKesson Technologies, Inc.<br />5995 Windward Parkway<br />Alpharetta, Georgia 30005<b> </b><br /><br /><b>Reason for Recall:</b> There was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR) in that it included data from another case. Use of this affected product may cause serious adverse health consequences, including death<b>.</b><br /><br /><b>Public Contact:</b> Customers with questions may contact McKesson Customer Support at <a href="tel:1-800-442-6767" target="_blank" value="+18004426767">1-800-442-6767</a> (option 3). For questions regarding this recall, call <a href="tel:404-338-3556" target="_blank" value="+14043383556">404-338-3556</a>.<b> </b><br /><br /><b>FDA District:</b> Atlanta District Office<b> </b><br /><br /><b>FDA Comments:<br /></b>On March 15, 2013, the firm initiated a Clinical Alert which was distributed to potentially affected customers. Phone calls were placed to each customer, followed up by an email. The firm provided their customers with written copies of the communication and Clinical Alert; and obtained acknowledgement that they read and understood the issue and preventive action to take.<br /><br />Customers with questions were instructed to contact McKesson Customer Support at <a href="tel:1-800-442-6767" target="_blank" value="+18004426767">1-800-442-6767</a> (option 3). For questions regarding this recall, call <a href="tel:404-338-3556" target="_blank" value="+14043383556">404-338-3556</a>.<br /><br />Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.<b> </b><br /><br /><b>Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to <a href="https://www.accessdata.fda.gov/scripts/medwatch/" target="_blank">MedWatch: The FDA Safety Information and Adverse Event Reporting Program</a> either online, by regular mail or by FAX.</b></blockquote><br />I encourage clinicians to take advantage of MedWatch with regard to bad health IT, anonymously if necessary to avoid internal repercussions or retaliation from executives who've spent hundreds of millions of dollars on the IT, and whose bonuses and promotions might be tied into its "success."<br /><br />-- SS</div>

EHR recall: Use of this affected product may cause serious adverse health consequences, including death

Here is another example of a grossly defective health IT product, this from last year but only posted by FDA publicly on 3/14/2014 at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsf…

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An Idiotically-Designed EHR Medication Discontinuation "Feature"

Over at The Healthcare Blog, Michael Chen, MD, a family physician and EHR designer in Portland, Oregon wrote a piece entitled "<b>Why EHR Design Matters</b>" (<a href="http://thehealthcareblog.com/blog/2013/12/18/why-ehr-design-matters/">http://thehealthcareblog.com/blog/2013/12/18/why-ehr-design-matters/</a>).  I am cited.<br /><br />Dr. Chen reports on a major commercial EHR with the following "feature":<br /><br /><blockquote class="tr_bq">... In this well known EHR, you are presented a medication list for a patient. As a physician, you assume that this list is a current medication list and is up to date.  However, the reality is that this EHR system automatically removes a medication from the list when it is determined to be expired even if it should be appearing on the current medication list.<br /><br />When a physician prescribes a medication from this system, it calculates the duration of usage of the medication based on the instructions, quantity of medication prescribed, and the number of refills.<b> Once the duration exceeds the number of days that has elapsed since the prescription was made, the medication is taken off the current list automatically by the EHR. </b> </blockquote><br />In other words, the EHR drops the medication from the meds list when the time elapsed exceeds the amount of time the total # of doses written for would be consumed.   As any medical student would say, "that's just brilliant."<br /><br /><blockquote class="tr_bq">Now, taken at face value, this sounds like the logical approach to manage a medication list and <b>utilizes the computing power that an EHR will gladly show off as a benefit to physicians</b>.</blockquote><br />Misuses, actually, and at the Warp-10 speeds of today's machines, that's a lot of misuse...<br /><br /><blockquote class="tr_bq">Unfortunately, <b>the EHR programmers failed to understand that medications are not taken regularly by all patients all the time</b>. In fact, no physician assumes that at all. So why should an EHR make that assumption? Furthermore, there are plenty of treatments that are to be taken only as needed so how can an EHR account for that? Absolutely, impossible.</blockquote><br />Perhaps the designers and programmers, simply brimming with medical degrees and expertise, thought they knew everything about medicine.  After all, you go to see a doctor, the doctor taps on you and squeezes here and there, puts a stethoscope on you, then pulls out a prescription pad and scribbles a few lines.  How hard can medicine be compared to, say, programming?<br /><br />Here's how this "feature" worked out in the real world: <br /><br /><blockquote class="tr_bq">So I recently treated a patient that reportedly has asthma. I happened to look at a previous note and find out that the <b>patient was denied a refill request for Albuterol</b>, a bronchodialator that is meant to be taken as needed. <b>She ended up in a life threatening asthma flare up and needed emergent care. It turns out the physician on call who was given the refill request several days prior didn’t realize that the EHR removed the Albuterol from her list</b> and subsequently instructed that the patient needed to have a physician visit for having the medication prescribed. After going through 2 different windows and unclicking a check box, I was able to identify that the patient did in fact have an active prescription for Albuterol, <b>but the EHR made it disappear.</b> She has used it infrequently, probably because her asthma was well controlled. <b>Unfortunately, she ended up in worse shape when she needed the medication the most.</b></blockquote><br />It's a good thing the patient didn't go into Status Asthmaticus (<a href="http://emedicine.medscape.com/article/2129484-overview">http://emedicine.medscape.com/article/2129484-overview</a>) and suffer severe complications, or die ... (if she had, would any of the system designers, programmers and/or purchasers have shared in liability?)<br /><br />I think it fair to say this EHR "feature" was idiotically conceived, designed and implemented, and that term is the most polite I can come up with.  Failure to know what they were doing, especially in the domain of medicine, compounded by failure to consult someone - even someone with basic medical commonsense -  who would see the folly and danger of such a "feature" is inexcusable.  <br /><br />The state of clinical IT will improve when such characters are placed very far from any computer that is to be used in life-critical settings, of which medicine is by definition, or at least have their work subject to rigorous testing and validation by those who know what they're doing. <br /><br />That will not happen, of course, until health IT is more rigorously regulated.<br /><br />-- SS

An Idiotically-Designed EHR Medication Discontinuation "Feature"

Over at The Healthcare Blog, Michael Chen, MD, a family physician and EHR designer in Portland, Oregon wrote a piece entitled "Why EHR Design Matters" (http://thehealthcareblog.com/blog/2013/12/18/why…

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"We’ve resolved 6,036 issues and have 3,517 open issues": Extolling EPIC EHR Virtues at University of Arizona Health System

The public may believe that, in healthcare, only the Obamacare insurance exchange website has lots of bugs.  On those, see my Oct. 10. 2013 post <b>"Drudge Report, Oct. 10, 2013, 9 AM EST: All that needs to be said about government, computing and healthcare"</b> at <a href="http://hcrenewal.blogspot.com/2013/10/drudge-report-oct-10-2013-9-am-est-all.html">http://hcrenewal.blogspot.com/2013/10/drudge-report-oct-10-2013-9-am-est-all.html</a>.<br /><br />Another pillar of the Affordable Care Act, electronic medical records (promoted with incentives for adopters and with penalties for non-adopters via the HITECH section of the 2009 economic recovery act or ARRA) are pretty damn bad themselves.  Only, those systems don't make it hard to find insurance.  Through bugs and other features of bad health IT, they directly interfere with safety and provision of quality care:<br /><br /><blockquote class="tr_bq"><span style="font-family: inherit;"><span style="color: black;"><b>Bad Health IT</b> ("BHIT") is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for <span class="SpellE">hypervigilance</span> (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.<span style="mso-spacerun: yes;">  </span></span></span></blockquote><br />At my Oct. 20, 2010 post <b>"Medical center has more than 6000 'issues' with Cerner CPOE system in four months - has patient harm resulted?"</b> (<a href="http://hcrenewal.blogspot.com/2010/10/medical-center-has-more-than-6000.html">http://hcrenewal.blogspot.com/2010/10/medical-center-has-more-than-6000.html</a>) I observed:<br /><br /><blockquote class="tr_bq">From the October 2010 "<i>News for Physicians affiliated with Munson Medical Center</i>" newsletter, a large medical center in Northern Michigan, about <span style="font-weight: bold;">more than six thousand</span> <span style="font-weight: bold;">"issues"</span> with their Cerner CPOE.<br /><br />... One wonders how many of those 6,000, and how many of the 600 remaining "issues" <a href="http://hcrenewal.blogspot.com/2009/03/draft-patient-rights-statement-and.html">fall into categories of</a> "<b>likely to cause patient harm in short term if uncorrected</b>" or "<b>may cause in patient harm in medium or long term</b>."<br /><br />I note that Cerner CPOE is <b><i>not a new product</i></b>, <i><b>nor are similar products from other vendors also afflicted with long lists of "issues."</b></i> That there could be more than 6,000 "issues" at a new site suggests deep rooted, severe problems with CPOE specifically and health IT design and implementation processes in general. </blockquote><br />Here's another such multi-"issue"-laden EHR, this at University of Arizona Health Network.  Image of frequent periodic "EHR Update" below.<br /><br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhgZkzPXU8Sfpv_3NWc4TPK2B79BvEEnxLU1_Y6OAXuVdcPoJYfHmde-XQXkeW7gO1iLUDVxRtzTpO7be0qDVU4nCD88O45plTy_9168SBdVJ2EiVBb9yChYToK_5OQJfDRSOyh6NF-HqUv/s1600/U_Az2.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhgZkzPXU8Sfpv_3NWc4TPK2B79BvEEnxLU1_Y6OAXuVdcPoJYfHmde-XQXkeW7gO1iLUDVxRtzTpO7be0qDVU4nCD88O45plTy_9168SBdVJ2EiVBb9yChYToK_5OQJfDRSOyh6NF-HqUv/s1600/U_Az2.jpg" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">"We’ve resolved 6,036 issues and have 3,517 open issues."</td></tr></tbody></table><div class="separator" style="clear: both; text-align: center;"></div><br />[Ignore the 'kewl dark sunglasses' worn by the hipsters at the top of this announcement.  Not sure if this has something to do with EPIC, but I consider the wearing of dark sunglasses by clinicians or any other staff in a hospital setting - where people are sick and/or dying - to be in exceptionally bad taste.]<br /><br />The text starts:<br /><br /><blockquote class="tr_bq"><b>ISSUES UPDATE as of 4:00 p.m., Nov. 8</b><br /><b>We’ve resolved 6,036 issues and have 3,517 open issues.</b></blockquote><br />That's a total of nearly ten thousand "issues."  As of now, that is.  "Issue" is a euphemism for "glitch" a.k.a. "software defect" and/or "implementation error", see <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a>.<br /><br />These "issues" are  in a supposedly "mature" product for which this organization has spent enormous sums of money, that has undergone "innovation" for several decades now - in an environment free from regulation, I might add.<br /><br />Many of the "issues" reduce patient safety, and could or already may have resulted in patient harm.  Such items on this listing, seen below, which is updated frequently, include:<br /><ul></ul><blockquote class="tr_bq"><ul><li>Pharmacy Medication Mapping Errors – Making good progress: watch for further notices.  <span style="color: red;"><i><b>[Perhaps these should have been tested and fixed before go-live? - ed.]</b></i></span></li></ul><ul><li>Microbiology Results Mapping Incorrectly <span style="color: red;"><i><b>[does that mean "mapping" to the wrong patient? - ed.]</b></i></span>  – all known errors fixed, monitoring and working on enhancements. <span style="color: red;"><i><b>[As above, perhaps these should have been tested and fixed before go-live? - ed.]</b></i></span><span style="color: red;"><i><b></b></i></span></li></ul><ul><li>Prescription printing - output for prescription printing has been fixed</li></ul><ul><li>Refill requests for providers will be routed to the CLIN SUPPORT In Basket pool for the provider’s department.  This was a decision made by UAHN leadership. <span style="color: red;"><i><b>[Not sure why this is being done; perhaps for approval by managers? - ed.]</b></i></span>  </li></ul><ul><li><b>Errors transmitting prescriptions</b> will also be sent to the CLIN SUPPORT In Basket. <span style="color: red;"><i> <b>[Errors transmitting prescriptions? That's not reassuring regarding data integrity.  See ECRI report below  - ed.]</b></i></span></li></ul></blockquote><ul></ul><br />This is not to mention that all of the <b>"reminders"</b> that follow are a distraction to clinical personnel, who cannot be expected to remember all of them.<br /><br />Bad as this is, at<b> my April 1, 2012 post "University of Arizona Medical Center, $10 million in the red in operations, to spend $100M on new EHR system" </b>(<a href="http://hcrenewal.blogspot.com/2012/04/university-of-arizona-medical-center-10.html">http://hcrenewal.blogspot.com/2012/04/university-of-arizona-medical-center-10.html</a>) I observed that:<b><br /></b><br /><blockquote class="tr_bq">... $100 million+ is probably enough to pay for AN ENTIRE NEW HOSPITAL or hospital wing ... or a lot of human medical records professionals. </blockquote><br />To add more bitter icing to this cake, I wrote about a campaign for clinicians to speak only in wonderful terms about the new U. Arizona Health System EHR<b> at my Oct. 3, 2013 post "Words that Work: Singing Only Positive - And Often Unsubstantiated - EHR Praise As 'Advised' At The University Of Arizona Health Network."  </b>I<b> </b>observed the following about the "words that work" is the shameless 'suggested' script:<br /><br /><blockquote class="tr_bq">• <span style="color: red;"><b><i>Efficient</i></b></span> - see aforementioned links as well as "Common Examples of Healthcare IT Difficulties" at <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/">http://cci.drexel.edu/faculty/ssilverstein/cases/</a><br /><br />• <span style="color: red;"><b><i>Convenient</i></b></span> - as above.  According to whom?  Compared to what?  Pen and paper?<br /><br />• <span style="color: red;"><b><i>Improves patient safety and quality</i></b></span> - see IOM report post at <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html</a> .  We as a nation <b>are only now studying safety of this technology</b>, and the results are not looking entirely convincing, e.g.<b> ECRI Deep Dive Study</b> of health IT safety 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>.  171 health IT mishaps in 36 hospitals, voluntarily reported over 9 weeks, with 8 reported injuries and 3 reported possible deaths is not what I would call something that "improves patient safety and quality" without qualifications.<br /><br />• <i><span style="color: red;"><b>The Cadillac of its kind</b></span></i> - according to whom?<br /><br />• <i><span style="color: red;"><b>Patients at hospitals using this system love it</b></span> </i>-  Do most patients even know what it, or any EHR, looks like?  Have they provided informed consent to its use?<br /><br />• <span style="color: red;"><i><b>Exciting </b></i></span>- clinician surveys such as by physicians at <a href="http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html">http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html</a> and by nurses at <a href="http://hcrenewal.blogspot.com/2013/07/candid-nurse-opinions-on-ehrs-at.html">http://hcrenewal.blogspot.com/2013/07/candid-nurse-opinions-on-ehrs-at.html</a> shed doubt on that assertion.<br /><br />• <span style="color: red;"><i><b>The best thing for our patients</b></i></span> - again, according to whom?<br /><br />• <b><span style="color: red;"><i>Sophisticated new system</i></span></b> - "New"?  Not so much, just new for U. Arizona Health.  "Sophisticated", as if that's a virtue?  Too much "sophistication" is in part what causes clinician stress and burnout, raising risk</blockquote><br />Considering the near 10,000 issues, the new ECRI Institute report <b>"Top Ten Technology Hazards in Healthcare"</b>, 2014 edition comes to mind (<a href="https://www.ecri.org/Press/Pages/2014_Top_Ten_Hazards.aspx">https://www.ecri.org/Press/Pages/2014_Top_Ten_Hazards.aspx</a>).  Named in that report, as has been the case for the past several years, is <b>healthcare IT. </b><br /><br />This year's problem description is:<br /><br /><blockquote class="tr_bq"><b>#4. <span class="UserContent">Data Integrity Failures in EHRs and other Health IT Systems</span></b></blockquote><br />"Data integrity failures" include "issues" (per the bad health IT description) such as: data loss, data corruption, data attributed to the wrong patient, etc.<br /><blockquote class="tr_bq"><br />ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research to healthcare to discover which medical procedures, devices, drugs, and processes are best to enable improved patient care. As pioneers in this science for 45 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. Strict conflict-of-interest guidelines ensure objectivity. ECRI Institute is designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality. ECRI Institute PSO is listed as a federally certified Patient Safety Organization by the U.S. Department of Health and Human Services. For more information, visit <a href="http://www.ecri.org/">www.ecri.org</a>.</blockquote><br />ECRI also produced the 2012 Deep Dive Study of Health IT Risk (<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>), where in a volunteer study at 36 member PSO hospitals, 171 health IT "mishaps" were reported in just 9 weeks, 8 of which caused patient injury and 3 of which may have contribute to patient death.<br /><br />In summary, The University of Arizona Health System, with components in the red, is spending hundreds of millions of dollars on an EHR system, that has had decades to mature. Yet, they are finding 10,000 "issues" already, a number of which reduce patient safety and are unresolved, with many more likely to be found.<br /><br />They are also 'advising' their staff to speak in glowing, unsubstantiated terms to patients about an EHR system that has 10,000 issues, and not seeking patient consent to its use in mediating and regulating their care - or giving elective patients the information that might allow them to choose another less "buggy" hospital.<br /><br />If (when) patient harm results from such cavalier hospital (mis)management, the juries are going to just love the dark sunglasses, I bet.<br /><br />-- SS

"We’ve resolved 6,036 issues and have 3,517 open issues": Extolling EPIC EHR Virtues at University of Arizona Health System

The public may believe that, in healthcare, only the Obamacare insurance exchange website has lots of bugs.  On those, see my Oct. 10. 2013 post "Drudge Report, Oct. 10, 2013, 9 AM EST: All that need…

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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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A Good Way to Cybernetically Harm or Kill Emergency Department Patients ... Via An ED EHR "Glitch" That Mangles Prescriptions

Yet another healthcare IT <b>"glitch"</b> - that banal little word used for potentially life-threatening software defects.  (See the query link <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a> for more examples.)<br /><br />An EHR/command and control system (including ordering, results reporting, etc.)  for hospital Emergency Departments, Picis Pulsecheck, was recalled by FDA.<br /><br />Reason?  "Notes associated with prescriptions<b> are not printed to the prescription or to the patient chart</b>."  The data apparently is not being sent to the printer or being stored for future visits.  Instead, data input by clinical personnel, in one of the most risk-prone medical settings, the Emergency Department, is <i><b>simply going away.</b></i><br /><br />This is reminiscent of the truncation of prescription drug "long acting" suffixes, apparently by a Siemens system, that led to thousands of prescription errors (perhaps tens of thousands) over more than a year's time.  I wrote about that matter, as reported by the news media, at "<b>Lifespan (Rhode Island): Yet another health IT "glitch" affecting thousands - that, of course, caused no patient harm that they know of - yet</b>" at <a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html</a>.  <br /><br />Regarding the current Picis recall, notes connected with prescriptions can be crucial to the pharmacist or the patient.  Loss of those notes - apparently due to a computer glitch and most likely in this case without the prescribing clinician knowing about it - likely have been going on for some time now, since two software versions (5.2 and 5.3) are affected. <br /><br />The solution for now?<br /><br /><blockquote class="tr_bq"><i>"Consignees were provided with recommended actions until they receive the necessary update."</i></blockquote><br />In other words, a workaround adding more work to clinicians who now not only have to take care of patients, but in the unregulated health IT market need to (as if they don't already have enough work to do in the ED where chaos often occurs) <b><i>babysit computer glitches as well</i></b> - and pray they catch potential computer errors 100% of the time. <br /><br /><span id="user_provided">Below is the FDA MAUDE recall notice at </span>"<b>Medical & Radiation Emitting Device Recalls</b>", from <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=119832">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=119832</a>.<br /><br /><a href="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1814-2013&w=08072013&lang=eng">At this additional link</a> we find that this FDA recall was "<span id="user_provided"><b>Voluntary: Firm Initiated</b>."  They apparently informed the FDA of the "glitch."</span><br /><br /><span id="user_provided">My question is - how did the company become aware of this "glitch"?  Also, were any patients put in harm's way, or injured, as a result of the prescription data loss?</span> <br /><br /><a href="https://www.blogger.com/null" id="main" name="main"><span id="pageTitleHolder"></span></a><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/AVvXsEh9P8LdAz5mRrOdrPBe9rkYWKhLdAuDrte6fxAO8peB0pBq7OJZbKHtwkwveUP0nsVxmBA2GKX-3R-bY8xq_4vc_-svQqadoh2lFek-y6VPNTzUca-ytPmktoeEQQ1AJptfBjAqitxv-ARC/s1600/picis_recall2.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh9P8LdAz5mRrOdrPBe9rkYWKhLdAuDrte6fxAO8peB0pBq7OJZbKHtwkwveUP0nsVxmBA2GKX-3R-bY8xq_4vc_-svQqadoh2lFek-y6VPNTzUca-ytPmktoeEQQ1AJptfBjAqitxv-ARC/s1600/picis_recall2.jpg" width="351" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">FDA Device Recall Notice.  Click to enlarge; text below.</td></tr></tbody></table><br /><blockquote class="tr_bq"><br /><table cellpadding="0" cellspacing="0" style="width: 100%px;"><tbody><tr><td width="33%"><br /></td><td align="left" style="color: #23238e; font-family: arial; font-size: 11pt; font-weight: bold;" width="34%">Class 2 Recall<br />ED PulseCheck</td><td align="right" width="33%"><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/relateditems.cfm?page_title=medical%20device%20recalls&item1_text=medical%20device%20recalls%20&item1_url=www.fda.gov/medicaldevices/safety/recallscorrectionsremovals/listofrecalls/default.htm&item2_text=fda%20enforcement%20report%20index&item2_url=www.fda.gov/safety/recalls/enforcementreports/default.htm"></a><br /></td></tr></tbody></table><table cellpadding="2" cellspacing="14"><tbody><tr> <th align="left" valign="top"><span style="font-size: x-small;">Date Posted</span></th> <td align="left" valign="top"><span style="font-size: x-small;">July 29, 2013</span></td> </tr><tr> <th align="left" nowrap="nowrap" valign="top"><span style="font-size: x-small;">Recall Number</span></th> <td align="left" valign="top"><span style="font-size: x-small;">Z-1814-2013</span></td> </tr><tr> <th align="left" valign="top"><span style="font-size: x-small;">Product</span></th> <td align="left" class="hardbreak" valign="top"><span style="font-size: x-small;">Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational purposes.</span></td> </tr><tr> <th align="left" valign="top"><span style="font-size: x-small;">Code Information</span></th> <td align="left" valign="top"><span style="font-size: x-small;">Software Versions 5.2 and 5.3</span></td> </tr><tr> <th align="left" valign="top"><span style="font-size: x-small;">Recalling Firm/</span><br /><span style="font-size: x-small;">Manufacturer</span></th> <td align="left" valign="top"><span style="font-size: x-small;">Picis Inc.</span><br /><span style="font-size: x-small;">100 Quannapowitt Parkway</span><br /><span style="font-size: x-small;">Suite 405</span><br /><span style="font-size: x-small;">Wakefield, Massachusetts 01880</span></td> </tr><tr> <th align="left" valign="top"><span style="font-size: x-small;">For Additional Information Contact</span></th> <td align="left" valign="top"><span style="font-size: x-small;">Support Representative</span><br /><span style="font-size: x-small;">781-557-3000 </span></td> </tr><tr> <th align="left" nowrap="nowrap" valign="top"><span style="font-size: x-small;">Reason for</span><br /><span style="font-size: x-small;">Recall</span></th> <td align="left" valign="top"><span style="font-size: x-small;"><b>Notes associated with prescription are not printed to the prescription or to the patient chart. </b></span></td> </tr><tr> <th align="left" nowrap="nowrap" valign="top"><span style="font-size: x-small;">Action</span></th> <td align="left" valign="top"><span style="font-size: x-small;">Initial customer notifications were sent via email on June 21, 2013 informing consignees of the recall and providing further instruction regarding the software solution. <b>Consignees were provided with recommended actions until they receive the necessary update.</b></span></td> </tr><tr> <th align="left" nowrap="nowrap" valign="top"><span style="font-size: x-small;">Quantity in Commerce</span></th> <td align="left" valign="top"><span style="font-size: x-small;">35</span></td> </tr><tr> <th align="left" nowrap="nowrap" valign="top"><span style="font-size: x-small;">Distribution</span></th> <td align="left" valign="top"><span style="font-size: x-small;">Nationwide Distribution, including the states of: AK, AR, AZ, CA, CO, DC, DE, FL, GA, ID, IN, MA, MD, MO, NH, NJ, OH, OR, SC, TN, WA, and WV.</span></td></tr></tbody></table></blockquote>Finally, I ask - how did this "glitch" escape the notice of the company before the software was put into production not in just one, but through two sequential versions?<br /><br />I propose that the lack of health IT regulatory controls due to special accommodation makes thorough software testing less "desirable" by a company (largely due to costs).<br /><br />Compare that to, say, software regulation in the Federal Aviation Administration:<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="http://www.faa.gov/documentLibrary/media/Order/8110.49%20Chg%201.pdf"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEijSv2nvIBYRtaq5Pv325j8_DLtIo_gReEvwpmezb_m6og2xIqMvpBwN4YxpERbCWff43VUyGuLrwOugZ4TLqYXVAMru4DCjbzBtf9j3cTDxUb8GNtB_YKT18MQFj_CqKKurXiG18YHpXML/s1600/faa_approval.jpg" width="247" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><b>FAA Aircraft Software Approval Guidelines</b> - available at <a href="http://www.faa.gov/documentLibrary/media/Order/8110.49%20Chg%201.pdf">http://www.faa.gov/documentLibrary/media/Order/8110.49%20Chg%201.pdf</a>.  Click to access.</td></tr></tbody></table><br />The FAA document begins:<br /><br /><blockquote class="tr_bq">"This order establishes procedures for evaluating and approving aircraft software and changes to appropriate approved aircraft software procedures."</blockquote><br />Software regulation in other mission critical industries like aviation and pharma make the health IT industry and its lack of regulation look pathetic.<br /><br /><br />-- SS

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A Good Way to Cybernetically Harm or Kill Emergency Department Patients ... Via An ED EHR "Glitch" That Mangles Prescriptions

Yet another healthcare IT "glitch" - that banal little word used for potentially life-threatening software defects.  (See the query link http://hcrenewal.blogspot.com/search/label/glitch for more exam…

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Today's Bad Health IT Systems: More Dangerous Than Paper?

I believe in 2013 that they are.<br /><br />(Definition of bad health IT is here:  <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/</a>)<br /><br />I recently posted about two "glitches" in a major EHR seller's clinical systems, Siemens Healthcare, affecting safety-critical functions of medication reconciliation and medication ordering.<br /><br /><ul><li><a href="http://hcrenewal.blogspot.com/2013/08/another-health-it-glitch-can.html">Another Health IT "Glitch" - Can Digital Disappearing Ink Kill Patients?</a> </li></ul><ul><li><a href="http://hcrenewal.blogspot.com/2013/08/can-digital-disappearing-ink-ehr-glitch.html">Can Digital Disappearing Ink (An EHR "Glitch") Kill Patients? Part 2</a></li></ul><br />Considering these, plus the many "glitches" reported by the only EHR seller who does so via FDA's MAUDE database (see here: <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html</a>), and the others posted at this blog at query link: <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a>, the following issue needs serious consideration by policymakers.<br /><br />Namely, the issue that enterprise electronic medical command-and-control systems, which today's "EHRs" in reality are, <b>are on their face more risk-prone than the paper systems they are replacing.</b><br /><br />The "glitches" reported above are clearly the tip of the iceberg due to industry norms of secrecy, the absence of most of the industry in reporting to FDA MAUDE or anywhere, and my limited sources of information.  It is likely the true level of "glitches" in live EHR/clinical IT installations is far, far higher  - conservatively, I believe, at least two orders of magnitude.<br /><br />Workarounds to IT "glitches" such as recommended in the Siemens bulletins at the aforementioned posts cause hospital officials to have to  reliably get the notices to all users of the systems, including medical students, nurses, physicians and allied health professionals.<br /><br />The workarounds also cause users to:<br /><br />1)  have to deviate from habits of use acquired in training and active use of the systems in question;<br />2) <b>remember</b>, without fail, to deviate from habits of use acquired in training and active use of the systems in question, in effect giving them the responsibility of caring for sick patients and for "sick" information technology;<br />3) keep in mind any other extant workarounds that exist waiting for "fixes"; and <br />4) be constantly on guard for information storage failures. <br /><br />In fact, the recent Siemens "glitches" and workarounds represent a clear danger to patient safety.  If these were more conventional medical devices, they'd be recalled.<br /><br />See my Dec. 14, 2011 post "<b>FDA Recalls Draeger Health IT Device Because This Product May Cause Serious Adverse Health Consequences, Including Death</b>" (<a href="http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html">http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html</a>) and July 23, 2012 post "<b>Health IT FDA Recall: Philips Xcelera Connect - Incomplete Information Arriving From Other Systems</b>"(<a href="http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html">http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html</a>) for examples where health IT defects similar to the Siemens issues were, in fact, recalled.<br /><br />Further, with paper records or tangible images, a page or image can be lost, or it can be illegible.  In the case of lost, in any quality paper record keeping system the information stewards or others using the paper (e.g., office staff or ward clerks) will generally note the absence and act accordingly.  Further, illegible notes or orders will most often be recognized as illegible and result in attempted clarification or other corrective actions.<br /><br />On the other hand, when electronic systems:<br /><br />1)  lose modified information en masse as in the Siemens examples but keep the old, or<br />2)  when outright errors such as en masse truncation occur (as in the thousands of prescriptions whose long-acting suffixes were cut off at Lifespan in Rhode Island, see "<b>Yet another health IT "glitch" affecting thousands</b>" here: <a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html</a>), or<br />3)  images are lost (see "<b>Potential Image Loss in GE Centricity PACS</b>" here:  <a href="http://hcrenewal.blogspot.com/2012/11/potential-image-loss-in-ge-centricity.html">http://hcrenewal.blogspot.com/2012/11/potential-image-loss-in-ge-centricity.html</a>) without warning-<br /><br /><i>- There are no "flags" that the obsolete, truncated or missing information is erroneous.</i><br /><br /><b>What remains is perfectly legible, perfectly convincing and perfectly deceiving.</b><br /><br />Electronic healthcare information systems on their face create more risk than paper record systems.  Further, the problem with "bugs" and "glitches" will not go away with today's industry models of "hiring down" and lack of regulation.  Every new upgrade or patch is suspect for introducing new bugs.<br /><br />Paper does not suffer these issues, unless disappearing ink is used to cross out the old and add new information ...<br /><br />Not that I am advocating for a return to 100% paper, but certain critical functions probably are best left to paper.  Further, hundreds of billions of dollars can certainly buy:<br /><br />1)  a lot of Health Information Management professionals to perform continuous QA of paper,<br />2)  a lot of document imaging systems to make the paper records available anywhere, anytime they are needed, and<br />3)  a lot of data entry personnel to relieve clinicians of clerical burdens so they may use their valuable experience more productively, as guest poster Howard Brody points out at <a href="http://hcrenewal.blogspot.com/2013/07/guest-post-incompetent-management.html">http://hcrenewal.blogspot.com/2013/07/guest-post-incompetent-management.html</a>.<br />4)  a lot of sensible regulation of this industry's product quality.<br /><br />-- SS<br /><br />

Today's Bad Health IT Systems: More Dangerous Than Paper?

I believe in 2013 that they are.(Definition of bad health IT is here:  http://www.ischool.drexel.edu/faculty/ssilverstein/cases/)I recently posted about two "glitches" in a major EHR seller's clinical…

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Medscape re: Class Action suit: "Doctors Who Sued EHR Company Win First Round"

Interesting article about a Class-Action lawsuit against a health IT seller, Allscripts, see Medscape link below (the story is copyrighted so I cannot repost it here).<br /><br />Relevant excerpts:<br /><br /><blockquote class="tr_bq">On Monday, March 4, a group of doctors who are suing their electronic health record (EHR) manufacturer for selling them a "buggy" product and then discontinuing it learned that the defendant's motion to block the lawsuit and compel them to accept binding arbitration was overruled by a judge in Miami, the first step in getting a court date in what is believed to be a first-of-its-kind case.<br /><br />... In December 2012, 4 physician practices -- 2 pain clinics in Florida, 1 in Missouri, and a family medicine practice in Alabama -- became plaintiffs in a class-action suit filed against Allscripts, "an action arising from an expensive, but defective electronic health records software product," according to the complaint. The bottom line: The EHR was "buggy."<br /><br />Says one of the doctors plaintiffs:<br /><br />Anesthesiologist Robert J. Joseph, MD, of the Pain Clinic of Northwest Florida in Panama City, a plaintiff in the suit, makes no bones about it. "Our EHR is a piece of crap," he states.</blockquote><br />-----<br /><br />Link to full article:<br /><a href="http://www.medscape.com/viewarticle/779721" target="_blank">http://www.medscape.com/viewarticle/779721</a><br /><br />(It seems to come up fulltext without Medscape login, but I cannot guarantee this will persist.)<br /><br />-- SS

Medscape re: Class Action suit: "Doctors Who Sued EHR Company Win First Round"

Interesting article about a Class-Action lawsuit against a health IT seller, Allscripts, see Medscape link below (the story is copyrighted so I cannot repost it here).Relevant excerpts:On Monday, Ma…

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Bad health IT and its effects on willingness of patients to share sensitive information

I call your attention to this video from the <b>2nd International Summit on the Future of Health Privacy</b> where HC Renewal occasional contributor Dr. Scott Monteith, a psychiatrist, presents on how health IT damages the physician-patient relationship, the bedrock of good medicine, in one case via an inexcusable health IT defect.<br /><br />The defect nearly cost a woman her good reputation - and her child - by "transforming" coffee drinking into solvent sniffing.<br /><br />The video is here:  <a href="http://www.healthprivacysummit.org/events/2012-health-privacy-summit/custom-129-ec40d08a35f947e487f68a5f534a9e82.aspx">http://www.healthprivacysummit.org/events/2012-health-privacy-summit/custom-129-ec40d08a35f947e487f68a5f534a9e82.aspx</a><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="http://www.healthprivacysummit.org/events/2012-health-privacy-summit/custom-129-ec40d08a35f947e487f68a5f534a9e82.aspx" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="178" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgS2ctf3aR4Od2Bas-tSrdYlO963ONIhluMMnfJ4PqF6gnU2QE8aefxAY08YzO3AgjN8hxWUT18SOKNirUmulqLb1Zbg7mzNbET9VfcD6g8SM1xA5JVVOCFhfXt3iPPs-E4za0PXHd0Vv76/s320/monteith.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Dr. Monteith on how bad health IT damages trust.  <b>See video <a href="http://www.healthprivacysummit.org/events/2012-health-privacy-summit/custom-129-ec40d08a35f947e487f68a5f534a9e82.aspx" target="_blank">at this link</a></b> starting at 4:40.</td></tr></tbody></table><br />Dr. Monteith starts at 4:40 when he is asked<br /><br /><blockquote class="tr_bq"><i><b>"Do you feel HIT affects the willingness of patients to share sensitive information with providers?"</b></i></blockquote><br />His answer is a definite <b>"yes"</b>, and the video should be seen to understand his reasons, the largest one being the trust that is injured by this technology as currently (mal)implemented, failing to maintain privacy, data integrity, affecting doctor-patient interaction (e.g., due to poor usability), etc.<br /><br />His two examples where HIT has injured trust, resulting in decreased willingness of patients to share sensitive information:<br /><br /><ul><li>A patient feared <b>compromised privacy</b> regarding psychiatric information (a fear that was certainly well-justified in view of ABC's recent expose of health IT breaches as I wrote about at my Sep. 14, 2012 post "<a href="http://hcrenewal.blogspot.com/2012/09/a-reason-to-refuse-use-of-ehrs-in-your.html">A Reason to Refuse Use of EHR's in Your Health Care, and Demand Paper</a>.")</li></ul><ul><li>An error in EHR-generated record <b>affecting a child custody battle, with a husband alleging unfitness of the mother due to substance abuse. </b> The EHR incorrectly showed a damaging diagnosis due to both a data mapping flaw (lumping multiple diagnoses under the same code) and a user interface flaw (permitting all of the diagnoses lumped under that code to not be seen, only the worst one) <b>that transformed caffeine (i.e., coffee) overuse to "inhalant abuse."</b>  </li></ul><br />Stunningly, Dr. Monteith reported the error was not remediated even after several years.<br /><br />As seen by the voluntary reports submitted by one of many HIT sellers (<a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html" target="_blank">link</a>), the only one that seems to do so, and some involuntary ones such as at <a href="http://google2.fda.gov/search?q=pulsecheck&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*&ie=UTF-8&ip=98.114.36.41&access=p&sort=date:D:L:d1&entqr=3&entqrm=0&oe=UTF-8&ud=1&filter=0" target="_blank">this link</a>, these issues are just the <b>"tip of the iceberg."</b> That exact phrase was uttered by a senior FDA official himself, reflecting known severe impediments to information diffusion on harms, as I reported <a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html" target="_blank">at this link</a>.<br /><br />Yet the government (e.g., HHS's <a href="http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__onc/1200" target="_blank">Office of the National Coordinator for Health Information Technology</a>, ONC) and IT industry push this technology like candy, emphasizing largely unproven benefits and completely ignoring downsides such as damaged trust, damaged reputations that could have cost a woman custody of her child, and damaged bodies.<br /><br />A video of an attorney personally affected by these issues is at this link:   <a href="http://www.healthprivacysummit.org/events/2012-health-privacy-summit/custom-137-ec40d08a35f947e487f68a5f534a9e82.aspx">http://www.healthprivacysummit.org/events/2012-health-privacy-summit/custom-137-ec40d08a35f947e487f68a5f534a9e82.aspx</a><br /><br />-- SS

Bad health IT and its effects on willingness of patients to share sensitive information

I call your attention to this video from the 2nd International Summit on the Future of Health Privacy where HC Renewal occasional contributor Dr. Scott Monteith, a psychiatrist, presents on how health…

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KevinMD: How algorithm driven medicine can affect (make more dangerous, actually) patient care

Reposted from KevinMD blog on another aspect of the health IT <a href="http://www.tinyurl.com/hostileuserexper">mission hostile user experience</a>. Emphases and comments in <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[red italics]</span> are mine:<br /><span style="font-weight: bold;"><br /></span><blockquote><span style="font-size:130%;"><a style="font-weight: bold;" href="http://www.kevinmd.com/blog/2012/01/algorithm-driven-medicine-affect-patient-care.html">How algorithm driven medicine can affect patient care</a></span><span style="font-weight: bold;font-size:130%;" > </span><span><br />by <a href="http://www.kevinmd.com/blog/post-author/jeffrey-parks" rel="tag">Jeffrey Parks, MD</a></span><br /><p><br /></p><p>Whenever someone is scheduled for an operation, the assigned nurse is required to fill out a “pre-op checklist” to ensure that all safety and quality metrics are being adhered to. Before the patient is allowed to be wheeled into the OR we make sure the surgical site is marked, the consents are signed, all necessary equipment is available, etc. One of the most important metrics involves the peri-operative administration of IV antibiotics. <a href="http://www.ashp.org/Import/PRACTICEANDPOLICY/PracticeResourceCenters/QualityImprovementInitiativeQII/LearnMoredup092253224960/SurgicalCareImprovementProjectSCIP.aspx">SCIP guidelines</a> mandate that the prophylactic antibiotic is given within an hour of incision time to optimize outcomes. This has been drilled into the heads of physicians, health care providers, and ancillary staff to such an extent that it occasionally causes total brain shutdown.</p><p><span id="more-62400"></span></p><p>Let me explain. For most elective surgeries I give a single dose of antibiotics just before I cut. For elective colon surgery, the antibiotics are continued for 24 hours post-op. This is accepted standard of care. You don’t want to give antibiotics inappropriately or continue them indefinitely.</p><p>But what about a patient with gangrenous cholecystitis or acute appendicitis? What if, in my clinical judgment, I want to start the patient on antibiotics right away (i.e. several hours before anticipated incision time) and then continue them for greater than 24 hours post-op, depending on what the clinical status warrants? <span style="font-weight: bold;">I should be able to do that right? <span style="font-style: italic; color: rgb(255, 0, 0);">[No - wrong - the idiots who designed your CPOE/Pharmacy IT system forgot that robotic medicine is bad medicine - ed.]</span><br /></span></p><p>Well, you’d be surprised. <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[No, actually, I'm not. I'd have been more surprised to see a system not impeding critical medical decisions tailored to the individual patient - ed.]</span><br /></p><p>You see, at two different, unaffiliated hospitals I cover, the <span style="font-weight: bold;">surgeons have seen that decision-making capability removed from their power</span>. If a young patient comes in with acute appendicitis and I feel that it would be prudent to continue the Zosyn an extra couple of days, an automatic stop order is triggered <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[presumably cybernetically - ed.]</span> in the department of pharmacy and the antibiotic is stopped after 24 hours, no matter what. Unless the surgeon specifically writes “<span style="font-weight: bold;">please do not stop this antibiotic </span> after 24 hours; it is being administered for therapeutic purposes, not prophylaxis <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[that sounds a bit like begging - ed.]</span> ,” the antibiotic will not be sent to the patient’s floor for administration. As a result, patients end up being treated sub-optimally, and potentially harmed, due to an over-emphasis on “protocol” and “quality care metrics.”</p><p>Similarly, the 60-minute timeline for pre-operative antibiotic administration can be problematic. I have had patients come into the ER with appendicitis or cholecystitis and, in my pre-op orders, write for Zosyn or whatever, to be started ASAP, no matter what time the operation is scheduled. Not too long ago, I admitted a gallbladder over the phone at 2am. I gave the nurse admitting orders which included one for a broad spectrum antibiotic.</p><p>When I saw the patient in the morning, I added her on to the OR schedule. By the time a room opened up, it was about 10:30am. The OR nurse asked me if I wanted to give an antibiotic for the case. I told her that the patient was already on antibiotics as part of her admit orders for treatment. The nurse shook her hand.<span style="font-weight: bold;"> It had never been given; the floor nurse held it so that it wasn’t administered until 60 minutes before the scheduled OR time, just like the algorithm dictates — despite the fact it had been ordered nearly 8 hours prior to the case, not for peri-op prophylaxis, but for treatment of an established pathology.</span> <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[This is how EHR-induced malpractice occurs, readers. Guess who bears liability? - ed.]</span><br /></p><p>And there it was, the cefotetan, hanging on her IV stand. Now nothing bad happened <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[this time, due to luck - ed.]</span>, but here you have a situation where health care providers are so terrified of violating Quality Assurance Protocol that they end up withholding necessary treatment. It’s just astounding. <span style="font-style: italic; color: rgb(255, 0, 0); font-weight: bold;">[It's astounding the surgeons don't simply use a scalpel on the computer terminal network and power cables to protect their patients - ed.]</span><br /></p><p>As surgeons, we have bitched and moaned. You would think that these issues would be quickly rectified. But no. It is the responsibility of the surgeon to write qualifying statements <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[a workaround to a 'feature' that turns medical judgment on its head - ed.] </span>for therapeutic antibiotics <span style="font-weight: bold;">because the default mode is to override a licensed physician’s clinical judgment.</span> <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[Not mentioned is who is overriding that judgment through cybernetic proxy - ed.]</span><br /></p><p>This is what I’m talking about when I say that blind allegiance to a top-down, systems analysis-driven algorithm can turn everyone involved in health care into a bunch of mindless drones.</p><p><em>Jeffrey Parks is a general surgeon who blogs at </em><a href="http://ohiosurgery.blogspot.com/" target="_blank">Buckeye Surgeon</a><em>.</em></p></blockquote><p><em></em></p><br />I will simply add that these issues sound like poor IT/protocol design and implementation, getting in a physician's way regarding <span style="font-style: italic;">tailoring of care to the individual patient</span>.<br /><br />An inviolable rule in health IT is - or needs to be -<br /><span style="font-family:arial;font-size:100%;"><br /></span><div style="text-align: center;"><span style="font-family:arial;font-size:100%;"><span style="font-size:130%;"><span style="font-size:85%;"><b>"You should not have to work around something that is not in the way</b>." </span></span></span><br /></div><br />There is nothing to debate or discuss on this issue.<br /><br />-- SS<br /><br style="font-weight: bold;"><span style="font-weight: bold;">Feb. 3, 2012 addendum:</span><br /><br />Some IT person (anonymously, of course) tried to argue and debate anyway; however, they did not even do basic homework. See their comments in the comments box.<br /><br style="font-weight: bold;"><span style="font-weight: bold;">Feb. 5, 2012 addendum:</span><br /><br />More in the comments section by someone saying they made the aforementioned comments, stating they are a hospitalist, and still trying to advance the same arguments in favor of physicians adapting to mission-hostile HIT and/or protocols rather than 'protesting too much.'

KevinMD: How algorithm driven medicine can affect (make more dangerous, actually) patient care

Reposted from KevinMD blog on another aspect of the health IT mission hostile user experience. Emphases and comments in [red italics] are mine:How algorithm driven medicine can affect patient care by…

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EHR Workstation Designed by Amateurs

Below is an actual workstation, in an ICU of a major regional hospital, to permit interaction with an already <a href="http://www.tinyurl.com/hostileuserexper">mission-hostile</a> EHR system:<br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjKoy5uEINVofkrjR5_5G5ZrmzgCLArIt7CcdS5gk9wM-Qk7T-GFlFldfLqcLmUCunoYoyO67RRcsE0m8z8C9CURrpn6rUBQQJlV7kDx8oXLsYMoLGy1k5jVS78peWOw-fFcwgh_jEN40m0/s1600/EHR_workstation.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5704232947644786402" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjKoy5uEINVofkrjR5_5G5ZrmzgCLArIt7CcdS5gk9wM-Qk7T-GFlFldfLqcLmUCunoYoyO67RRcsE0m8z8C9CURrpn6rUBQQJlV7kDx8oXLsYMoLGy1k5jVS78peWOw-fFcwgh_jEN40m0/s320/EHR_workstation.jpg" style="cursor: pointer; display: block; height: 222px; margin: 0px auto 10px; text-align: center; width: 367px;" /></a></div><div style="text-align: center;">How many things are wrong here? (Click to enlarge)<br /><br /><br /><div style="text-align: left;">I can charitably say this workstation, in this recent picture, was designed by amateurs. Less charitably, I would use the words 'glaring incompetents.'<br /><br />How many things are wrong here? For starters (commenters are welcome to suggest additions to the list):<br /><br /><ul><li>Small square (4x3) monitor, when large 16x9 monitors are available quite cheaply, even at retail let alone in bulk;</li></ul><ul><li>Monitor in front of window so on sunny days, glare causes eye strain;</li></ul><ul><li>Monitor forces user to look away from the patient, with their back facing the patient behind them;</li></ul><ul><li>Standard keyboard and mouse to help spread infection, not medical-specialty devices such as membrane-based or membrane-covered keyboards and easily cleanable trackpads;</li></ul><ul><li>Very slow, small, toy-ish <a href="http://en.wikipedia.org/wiki/Nettop">nettop computer</a>, to facilitate responsiveness delays;</li></ul><ul><li>Height of ledge with keyboard/mouse and of elevated monitor on ledge does not facilitate comfortable ergonomics when sitting, note chair in background (or standing as is intended, either, although I don't recall ever making entries in the permanent paper chart on my feet). It seems nobody ever heard of an appropriate moveable workstation desk;</li></ul><ul><li>Tangle of wires behind setup, without any protective sheath or shield, facilitates "accidents."</li></ul><br />There are probably a few more "issues" I'm missing.<br /><br />There is nothing to argue here and nothing to debate. Combined with the mission hostile <span style="font-style: italic;">virtual</span> user interfaces presented by health IT software itself, this is inexcusable.<br /><br />Apart from designers, any physicians (and nurses) who would accept such poor choices - <span style="font-style: italic;">and the cause of this workstation's problems were, in fact,<span style="font-weight: bold;"> deliberate choices</span></span> - are either weak-kneed victims of "<a href="http://hcrenewal.blogspot.com/2007/10/physicians-learned-helplessness.html">physician's learned helplessness</a>" themselves, or enjoy EHR-induced medical errors and lawsuits.<br /><br />The workstations are poorly designed like this all throughout this hospital, including the ED.<br /><br />This is not the first time I've observed this type of amateurism in hospitals. I observed similar issues in <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU">another ICU</a> - <span style="font-style: italic;">over a decade ago</span>.<br /><br />Hospitals are truly an IT backwater.<br /><br />-- SS</div></div>

EHR Workstation Designed by Amateurs

Below is an actual workstation, in an ICU of a major regional hospital, to permit interaction with an already mission-hostile EHR system:How many things are wrong here? (Click to enlarge)I can charit…

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NIST on the EHR Mission Hostile User Experience: Blame the User? Nyet...

I have often had to respond to those who claim that EHR's don't cause medical errors, users do. That subset of the health IT irrationally exuberant seem common in the health IT industry and pundit channels.<br /><br /><a href="http://www.nist.gov/index.html">NIST</a> (The U.S. National Institute of Standards and Technology) has recently issued a draft report <span style="font-weight: bold;">"</span><span style="font-weight: bold;">NISTIR 7804: Technical Evaluation, Testing and Validation of the Usability of Electronic Health Records</span>.<span style="font-weight: bold;">"</span> It is available at <a href="http://www.nist.gov/healthcare/usability/upload/Draft_EUP_09_28_11.pdf" rel="nofollow">http://www.nist.gov/healthcare/usability/upload/Draft_EUP_09_28_11.pdf</a> (PDF).<br /><br />The report is quite negative concerning the low usability of today's commercial health IT, and recommends significant improvements <span style="font-style: italic; font-weight: bold;">that have been standard practice in other mission- and life-critical IT sectors for decades.</span><br /><br />I will have more to write about this report, but I found a passage and footnote early in the report striking.<br /><br />Of note, from the new NIST draft report:<br /><br />This passage, from page 10:<br /><br /><blockquote>The EUP (EHR usability protocol) emphasis should be on ensuring that necessary and sufficient usability validation and remediation has been conducted so that <b>use error</b> [3] is minimized.<br /><br />[3] <span style="font-weight: bold;">“Use error”</span> is a term used very specifically to refer to user interface designs that will engender users to make errors of commission or omission. <b>It is true that users do make errors, but many errors are due not to user error per se but due to designs that are flawed</b>, e.g., poorly written messaging <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[or lack of messaging, e.g., no warnings of potentially dangerous actions - ed.]</span>, misuse of color-coding conventions, omission of information, etc. <span style="font-weight: bold; font-style: italic;"><span style="color: rgb(255, 0, 0);"><br /></span></span><br /></blockquote>This passage describes what I have termed a <span style="font-weight: bold; font-style: italic;"><a href="http://www.tinyurl.com/hostileuserexper">mission hostile user experience</a>.</span><br /><br />"Blame the user" as the default, reflex reply to clinical IT-related medical errors, and the "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda">hold vendor harmless for defects</a>" clauses that facilitate this excuse are now heading to the junkpile - in the clinic, hospital, and courtroom.<br /><br />It is my hope that the the Wild West, free-for-all, cavalier, get out of jail free days of the health IT industry are coming to a close.<br /><br />Hint to health IT industry: you may actually need to invest in people who know what they're doing, instead of hiring the cheapest labor possible. (See, for example, my Aug. 2010 post<br />"<span style="font-weight: bold;"></span><a href="http://hcrenewal.blogspot.com/2010/08/epics-outrageous-recommendations-on.html">EPIC's outrageous recommendations on healthcare IT project staffing</a>" for more on that issue.)<br /><br />-- SS<br /><br /><span style="font-weight: bold;">Oct. 25, 2011 Addendum:</span><br /><a href="http://histalk2.com/2011/10/24/thoughts-on-nists-ehr-usability-document-102411/#comment-17581"><br />This comment</a> (#5, October 25th, 2011 at 12:38 pm) by "a practicing front-end designer and application developer" over at HIStalk is quite interesting. The writer points out the differences between <span style="font-style: italic;">designers</span> and <span style="font-style: italic;">developers</span>, and opines that:<br /><br /><blockquote>If you’re going to improve vendor design, it has to begin with an <span style="font-weight: bold;">internal commitment to value designers</span> and what they contribute to the product development process. They can not be an afterthought. There are very few companies with this mindset. <span style="font-weight: bold;">Almost all HIT companies are developer-driven</span>, so the first thought, and one that is promoted in this report, is to turn developers into designers. This will not work! <span style="font-weight: bold;">A developer and a designer require </span><span style="font-weight: bold;">two fundamentally different skill sets</span> that are not easily transposed. Developers are trained to think rationally and analytically; <span style="font-weight: bold;">design requires empathy for the use</span><span style="font-weight: bold;">r</span>. </blockquote><br />In health IT, empathy for the patient as well, I might add.<br /><br />-- SS

NIST on the EHR Mission Hostile User Experience: Blame the User? Nyet...

I have often had to respond to those who claim that EHR's don't cause medical errors, users do. That subset of the health IT irrationally exuberant seem common in the health IT industry and pundit ch…

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Australia and Health IT: Will Government Officials Ever Learn?

Perhaps New Zealand professor Shaun Goldfinch's article "<span style="font-weight: bold;">Pessimism, Computer Failure, and Information Systems Development in the Public Sector</span>" should be required reading in their neighboring continent due northwest:<br /><br /><b style=""><span style=";font-family:Arial;font-size:10pt;" ></span></b><blockquote><span style="font-size:100%;"><b style=""><span style="font-family:Arial;">Pessimism, Computer Failure, and Information Systems Development in the Public Sector.</span></b></span><span style=";font-family:Arial;font-size:100%;" ><span style=""> </span>(Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand).<span style=""> </span>Cautionary article on IT that should be read by every healthcare executive documenting the widespread nature of IT difficulties and failure, the lack of attention to the issues responsible, and recommending much more critical attitudes towards IT.<span style=""> </span><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Goldfinch_pessimism_PAR.pdf">link</a> to pdf</span></blockquote><br />Here's what's about to "go down" (no pun intended) Down Under, this time in the Australian state of <a href="http://en.wikipedia.org/wiki/Queensland">Queensland</a>:<br /><blockquote><br /><a style="font-weight: bold;" href="http://www.couriermail.com.au/news/queensland/health-software-on-the-sick-list/story-e6freoof-1226142181877">Queensland Health eyes software system despite red flags </a><br /><span style="font-weight: bold;">Koren Helbig</span><br /><span style="font-weight: bold;">From: The Courier-Mail</span><br /><span style="font-weight: bold;">September 21, 2011 12:00AM</span><br /><br />QUEENSLAND Health is poised to sign a multimillion-dollar contract for computer software similar to that labelled "defective" by an IT expert who audited its use in southern hospitals.<br /><br />University of Sydney's Professor Jon Patrick said electronic medical records systems built by Cerner Corporation for the NSW Government crashed frequently and risked patient safety.<br /><br />A similar Cerner system installed by the Victorian health department also has been plagued by glitches and is five years behind schedule.</blockquote><br />Dr. Jon Patrick's detailed forensic analysis of a Cerner ED system is <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">at this link</a> and has been a subject of numerous posts on this blog.<br /><br /><blockquote>"I don't think there's any reason for optimism that they can be improved," Prof Patrick said.<br /><br />Leaked internal documents have surfaced detailing problems already looming within Queensland, as bureaucrats negotiate with US-based Cerner to build a $243 million electronic medical records system in Queensland hospitals.<br /><br />Technical information for the proposed Cerner system and existing IT platforms that it must work with was "often incomplete, not-comprehensive, inaccurate and out-of-date", a leaked position paper found.<br /><br />Another email addressed to chief information officer Ray Brown, released to the State Opposition under Right to Information laws, <span style="font-weight: bold;">warned of the increasing need to document potential risks "even if we can't find the resources to remove them" in case of disaster and patient death.</span></blockquote><br />I guess dead patients can't complain about that, unless provided with underground megaphones.<br /><br /><blockquote>"The no-surprises rule may be applicable and would help in a Coroner's Court," the clinical adviser wrote.<br /><br />But, in a written statement, Mr Brown last night backed Cerner, which he said had successfully operated systems at the Royal Brisbane and Women's and Princess Alexandra hospitals for more than a decade.</blockquote><br />A few anecdotes of success, let's ignore those pesky anecdotes of problems, and - WHAM! - let's spend billions and roll this out statewide/nationwide.<br /><br />The problem with this (il)logic was well-explained by another physician Down Under who chooses to remain anonymous. See my August 2011 post "<span style="font-weight: bold;">From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things</span>" <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">at this link</a>. Read it carefully....<br /><br /><blockquote>Mr Brown said Queensland had learnt from interstate problems and would implement an "end-to-end solution", rather than trying to marry different systems across hospitals.<br /><br />Independent experts had verified the rollout and more than 4000 staff had been consulted, indicating their support for Cerner software, he said.<br /><br />The debate came after The Courier-Mail yesterday detailed Opposition claims that Queensland Health bureaucrats deliberately changed an independent report to favour Cerner when hunting for software suppliers in 2009, which QH vehemently denied.<br /><br />Prof Patrick, chair of Language Technology at the university's School of IT, said problems with Cerner's NSW and Victorian systems were well documented in 2009.<br /><br /><span style="font-weight: bold;">He said Queensland bureaucrats likely knew of the faults, which should have served as "red flags".</span><br /><br />Cerner did not respond to a call for comment.</blockquote><br />May I suggest that "red flags" often get ignored when the color green is present, at least in the U.S. (I don't know the colors of Australian currency.)<br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiHLTMH1usG4D_gk7S1KF2vxfi2nsRdQGPHK9P7YUhyphenhyphen8STBFJf-NZ-HN9pvkfeW9VgUFkbuXktE-bog-sEHeBK4-Eb-OhOa5B12sVmgfJU5mG_eyj_VqR8BM6yqsS6K3Di9nyyfyyParK99/s1600/100k.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5654573291010095522" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiHLTMH1usG4D_gk7S1KF2vxfi2nsRdQGPHK9P7YUhyphenhyphen8STBFJf-NZ-HN9pvkfeW9VgUFkbuXktE-bog-sEHeBK4-Eb-OhOa5B12sVmgfJU5mG_eyj_VqR8BM6yqsS6K3Di9nyyfyyParK99/s320/100k.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 381px; height: 161px;" /></a><span style="font-size:85%;">Who cares about "Red flags" when you can have wads of these?</span><br /></div><br /><br />-- SS<br /><br /><span style="font-weight: bold;">Addendum: </span><br /><br />Dr. Patrick notes this at his aforementioned university page:<br /><br /><blockquote>3.13 Statement on 22nd August 2011. I attended the HIC conference in Brisbane in the beginning of August and at a dinner hosted by IBM on the 2nd August I met Mr Greg Wells, the CIO of HSS, and the person responsible for the FirstNet roll out in NSW. <span style="font-weight: bold;">He stated that Cerner had provided new software that would solve all of the User Interface problems and it was being rolled at the present time in the Northern Area Health Service region.</span> He said all installations across the state would have this solution by Christmas this year. We shall watch with interest. </blockquote><br />I guess solving problems <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=120&Itemid=116">like these</a> simply takes a lot of pizzas and Coca-Cola.<br /><br />-- SS

Australia and Health IT: Will Government Officials Ever Learn?

Perhaps New Zealand professor Shaun Goldfinch's article "Pessimism, Computer Failure, and Information Systems Development in the Public Sector" should be required reading in their neighboring continen…

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EHR ED's in New South Wales. Will the Problems Magically "Disappear?"

It occurs that one could look at Prof. Jon Patrick's recent <a href="http://hcrenewal.blogspot.com/2011/03/on-emr-forensic-evaluation-from-down.html">health IT forensic analysis</a> as a kind of "indictment" of the industry.<br /><br />He can be seen as suggesting the industry needs to be "put on trial" (figuratively) regarding "crimes" (again, figuratively speaking) they've committed with regard to IT robustness and reliability. The latter translate directly to patient safety.<br /><br />In a lawsuit such as a medical malpractice trial, obvious as well as potential evidence is put under "legal hold." For instance, if an EHR defect is suspected, metadata, audit trails, and patient data are asked (or should be asked) to be frozen or archived in the state they were in at the time of the alleged accident.<br /><br />It can take a page or three (or more) of specifications simply to define what information, exactly, needs to be put on legal hold. My former staff were frequently required to place myriad materials on legal hold at Merck Research Labs, for example, baed on the <span>lawsuit</span><span style="font-style: italic;"> du jour</span>.<br /><br />Once frozen, discovery and forensic analysis of these now-static data can then proceed. In fact, cases can be lost on the basis of evidence of an archiving omissions, destruction or tampering when information holds are requested.<br /><br />It occurs to me that Prof. Patrick has given the industry a detailed look into factors they could start to remediate, without publicity and without telling anyone. While this would be a net plus for patients, it might result in less of a learning experience to the industy than that industry needs, to motivate the industry to avoid future product engineering and quality issues and put quality (not simply margin) as priority #1.<br /><br />I therefore would believe a "hold" put on the present state of these ED EMR systems, or a "snapshot" of their current state (i.e., an evaluation environment mirrored from the present operational one) would allow a careful evaluation of the impact of the issues noted in the study.<br /><br />Such an evaluation would be far more difficult with a cybernetic moving target.<br /><br />The "snapshot" idea would allow evaluation of system risk levels, intermittent "glitches", interference with workflows, etc. in a controlled testing environment, using mock data or data drawn from actual cases.<br /><br />The "snapshot" approach would also allow incremental remediation of the "live" system that comes out of safe, controlled testing, rather than sticking with what exists now until the studies could be completed on the as-is system, and then applying all the fixes as one or more large "upgrades."<br /><br />I, for one, would be interested in studying this "built by software professionals" system and comparing it to health IT systems we "academic nerds" <a href="http://ycmi.med.yale.edu/trialdb/">were authoring</a>, say, 10-15 years ago.<br /><br />-- SS

EHR ED's in New South Wales. Will the Problems Magically "Disappear?"

It occurs that one could look at Prof. Jon Patrick's recent health IT forensic analysis as a kind of "indictment" of the industry.He can be seen as suggesting the industry needs to be "put on trial" (…

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On an EMR Forensic Evaluation by Professor Jon Patrick from Down Under: More Thoughts.

<div style="text-align: center;"><span style="font-size:85%;"><span style="font-style: italic;"><span style="font-weight: bold;">Note:</span> the reports to which this post refers are available as a set of PDF's from the University of Sydney, NSW, Australia </span><a style="font-style: italic;" href="http://www.it.usyd.edu.au/%7Ehitru/essays/Study%20of%20Enterprise%20Health%20IS%20-%20Parts%200-9%20PDF-ARCHIVE.zip">at this link</a><span style="font-style: italic;"> (12 Mb, .zip folder), or at </span></span><span style="font-style: italic;font-size:85%;" class="Apple-style-span" >"<span style="font-weight: bold;">A study of an Enterprise Health information System</span>" at <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146</a></span><span style="font-size:85%;"><span style="font-style: italic;">.</span></span><br /><span style="font-size:85%;"><br /></span><div style="text-align: center;"><span style="font-size:85%;"><span style="font-style: italic;"><span style="font-weight: bold;">March 6, 2011 addendum</span>. Also see my new post "</span><a style="font-style: italic;" href="http://hcrenewal.blogspot.com/2011/03/what-to-do-about-state-of-ed-ehr-in-nsw.html"><span style="font-weight: bold;"></span>What to do about the state of the ED EHR in NSW?</a><span style="font-style: italic;">"</span></span><br /></div></div><br />Over ten years ago now, 1999 in fact, I started my healthcare IT difficulties website.<br /><br />That site, "<span style="font-weight: bold;">Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties</span>" now resides on a Drexel University server in Philadelphia, Pennsylvania USA <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">at this link</a>, and used as a teaching resource.<br /><br />I started the site after observing, for lack of a better description, "crazy stuff" in the commercial healthcare information technology sector.<br /><br />Crazy stuff such as EMR systems for ICU's that <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU">crashed regularly and spread pathogens around</a>, EMR's for invasive cardiology cath labs <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story">that were an informational jumble and abyss and that also issued regular General Protection Faults and died</a>, lack of Medical Informatics expertise (and actual disdain for it) in healthcare IT projects, grossly incompetent IT leaders, and hospitals uncritically and enthusiastically buying these products as if they were a plug and play, proven technology.<br /><br />To make matters worse, I also observed executives expressing a <span style="font-weight: bold;">hostile indifference</span> to glaring deficiencies.<br /><br />My observations about health IT and about responses to my counsel brought to mind the biblical passage:<br /><br /><blockquote><span style="font-style: italic;">"Give not that which is holy unto the dogs, neither cast ye your pearls before swine, lest they trample them under their feet, and turn again and rend you."</span> - Matthew 7:6<br /></blockquote><br />I was never afforded the opportunity to perform a forensic analysis of the internals of these systems, being that I was not allowed to obtain the software or "schematics" of the data structures. In fact, to make the cardiology system usable, I ordered the IT staff to simply discard the internal data dictionary, relational data structures, input screens, and analytic routines, and rebuild them - from scratch - using a proper Medical Informatics-based, cardiology domain expert-driven, iterative and incremental (agile) approach.<br /><br />The result was a resounding success, and was described in a written report as "exceptional" by national specialty association reviewers invited to evaluate the effort.<br /><br />(A success for which, I might add, I and my enlightened executive sponsor <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story">were paradoxically demonized by the IT department and hospital executives</a>; cf. Matthew 7:6.)<br /><br />Now, an Australian researcher of considerable computer and database expertise, <a href="http://sydney.edu.au/engineering/it/%7Ejonpat/">Professor Jon Patrick</a> at the University of Sydney, has put considerable ink to a forensic evaluation of the internals and external reactions to an EMR system "built in America", <span style="font-weight: bold;">Cerner Firstnet</span>.<br /><br />Professor Patrick holds a Ph.D. from Monash University. He came to the University of Sydney from Massey University, New Zealand, where he held the foundation Chair of Information Systems. Professor Patrick won Australia's national Eureka science prize in 2005 for developing a natural language processing system that detected financial scams in web pages at the behest of the Australian Government.<br /><br />FirstNet is an ED EHR that government officials decided must be installed in ED's of public hospitals throughout the Australian state of New South Wales. Promo material below, click to enlarge:<br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjWv3btAUsn_Umf2ZFMjq6HXIZ6BgHxlc835DJCPhyBPJzoY8PVpBuM_w6id8ohYVEfHWPPvBvQWjowc_kQWlqenx4WezZU_6sWBRcil-j5bO9RUr-N9MOP3r3X0GgM2qAiR_vQu73S2rl5/s1600/p1.png"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5580655476444502130" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjWv3btAUsn_Umf2ZFMjq6HXIZ6BgHxlc835DJCPhyBPJzoY8PVpBuM_w6id8ohYVEfHWPPvBvQWjowc_kQWlqenx4WezZU_6sWBRcil-j5bO9RUr-N9MOP3r3X0GgM2qAiR_vQu73S2rl5/s320/p1.png" style="display: block; margin: 0px auto 10px; width: 247px; cursor: pointer; height: 320px; text-align: center;" /></a><span style="font-size:85%;">FirstNet promo material, page 1. Click to enlarge. (Hmm ... Is there a subliminal message in the picture of the doctor and nurse?)</span><br /><br /><br /></div><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgtd0yVxqvX4M2SebLq7XUMfF-4lum_lGcfgEsmXc75o6s4INr4HJfRIFh7YZPdlj1RqedKjnVVNjIbTvFIZCbybSvpWGIYDV8dqMZf8NqC1c3vDe14bEjjvq-oZeN3R3SOoGA2mTH7ZC1N/s1600/p2.png"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5580655538113430082" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgtd0yVxqvX4M2SebLq7XUMfF-4lum_lGcfgEsmXc75o6s4INr4HJfRIFh7YZPdlj1RqedKjnVVNjIbTvFIZCbybSvpWGIYDV8dqMZf8NqC1c3vDe14bEjjvq-oZeN3R3SOoGA2mTH7ZC1N/s320/p2.png" style="display: block; margin: 0px auto 10px; width: 247px; cursor: pointer; height: 320px; text-align: center;" /></a><span style="font-size:85%;">FirstNet Promo material, page 2. Click to enlarge.</span><br /></div><br />The initiative's been underway for several years, and the result is a group of apparently very unhappy Wal-Mart shoppers. (I guess the correct line would be "unhappy <a href="http://en.wikipedia.org/wiki/Big_W">Big W</a> shoppers" for those Down Under.)<br /><br />Prof. Patrick had written a preliminary essay on the issue entitled<span style="font-weight: bold;">, </span>in rhetorical question-style,<span style="font-weight: bold;"> "The Story of the Deployment of an ED Clinical Information System: Systemic Failure or Bad Luck?"</span> back in 2009. He apparently found himself in considerable hot water for doing so due to 'pushback' as I described at "<a href="http://hcrenewal.blogspot.com/2009/11/academic-freedom-and-ed-ehrs-down-under.html">Academic Freedom and ED EHR's Down Under: An Update</a>". However, his university stood by him in defense of academic freedom (and of the sanctity of those in the healing arts, I might add).<br /><br />He's spent the intervening time expanding the analysis of the ED clinical system and its deployment considerably, right down to the fine nuances of relational database design in complex domains (such as biomedicine).<br /><br />As I wrote in an initial post "<a href="http://hcrenewal.blogspot.com/2011/03/study-of-enterprise-health-information.html">A Study of an Enterprise Health information System - Finally, an Informatics Scientist Does A Rigorous Review of a Commercial EHR System, by Cerner</a>", the TOC of his new analysis are these (the files are available as a .zip archive <a href="http://www.it.usyd.edu.au/%7Ehitru/essays/Study%20of%20Enterprise%20Health%20IS%20-%20Parts%200-9%20PDF-ARCHIVE.zip">at this link</a>):<br /><br /><blockquote>3.0 Part 0 - Executive Summary<br />3.1 Part 1 - A Critical Essay on the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck? First published here in Oct 2009, revised Dec 2009.<br />3.2 Part 2 - Discussions with ED Directors: Are we on the right track?<br />3.3 Part 3 - Discussions with Software Performance Experts.<br />3.4 Part 4 - Conceptual Data Modelling.<br />3.5 Part 5 - Database Relational Schema and Data Tables.<br />3.6 Part 6 - Coalescing the Analyses of the ER Diagrams, Relational Schemata and Data Tables.<br />3.7 Part 7 - The Integrated Assessment.<br />3.8 Part 8 - Future HIT Regulation Proposals.<br />3.9 Part 9 - Ockham's Razor of Design. Published at the IHI conference, Nov 2010 Washington.</blockquote><br />I have been reading these sections, and have found the technical sections (parts 4-6) highly informative about a major suspicion I've held for many years.<br /><br />I suspected chaos in the health care IT software engineering process, with inadequate attention to quality, rigor, fine detail, resilience engineering, talent management and other practices essential in development of mission critical products of any type.<br /><br />Prof. Patrick's forensic analysis, while not proof of my concerns, certainly supports them. If Boeing produced aircraft with malfunctioning engines, broken seats, defective flaps, tires that blew on landing, and rust right out of the factory (like the Chevy Vega of old?), one might suspect the development and manufacturing environment could be substantially problematic.<br /><br />The theme of apparent violations of fundamental precepts of relational database design run consistently through his analysis of the FirstNet product.<br /><br />Without getting too technical (which I can, having written successful <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/medinformatic1/saudi.htm">r</a><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/medinformatic1/saudi.htm">elational database-based clinical information systems</a> of considerable complexity for challenging environments, with novel user interaction design besides), I see evidence of developmental chaos.<br /><br />Examples: primary key-foreign key inconsistencies and problematic usages ("keys" are flags used to link sets of information about some object or entity, such as a patient to their diagnoses or meds), internal field nomenclature faux pas (there are best practices on how to do this to enhance software quality and maintenance), cryptic documentation , "stale bits" (old code and data) from past iterations remaining to create "glitches", unreliabilities and new problems, and other technical sins apparently abound.<br /><br />These can be read about in sections 4-6 of Prof. Patrick's analysis. The issues can be summarized as he did in the part 6 Abstract:<br /><blockquote><br />Consistent weaknesses in sections of the Millenium clinical information System (CIS) are revealed in the combined study of the ERD (entity-relationship diagram), logical schema and the data tables. PK (primary key, i.e., unique identifier) values are not always defined unambiguously at the design level and data tables reveal inconsistencies in declarations and data validation. There is evidence that keys are managed by software within the application rather than by the in-built functions available in the database management system leading to less confidence in data integrity.<br /><br /></blockquote>He goes on to relate:<br /><blockquote><br />The [technical design] weaknesses in terms of clinical work practices, that have been identified are only likely to show up in <span style="font-weight: bold;">occasional circumstances</span> with a combination of processing and data values separated in time. <span style="font-weight: bold; color: rgb(255, 0, 0); font-style: italic;">[In other words, the resulting errors are unpredictable, and depend on variable factors about the patient's data and user's attempted actions that cannot be predicted ahead of time - ed.]</span> Staff are not likely to associate one instance of missing or mis-processed data with another. <span style="font-weight: bold;">This spasmodic nature tends to lull staff into a false sense of security that the mis-processing is either inconsequential or an accident of their own making.</span> We recommend that each and every mis-processing experience be recorded as accurately as possible so that appropriate computational forensic analysis can correctly identify if weaknesses in the underlying technology have been the source.<br /></blockquote><br />These are dead-serious matters, literally. One's well being in an ED should not depend on random chance. If you are the "lucky patient" who Wins the Lottery or Hits the Jackpot on health IT mis-processing, or whose clinicians are distracted by user experience flaws, "workarounds", demoralization or other issues, you might end up maimed - or in the grave.<br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiZ20IJBLu5ePEUKL0bwFA8RSyWPjKFQDm5YHVAcwwbU_9imWz6YVp8pp8QbDpSEoZ1F4TNzVfWia13tgGqFCynsMZviaTQuc2D5QfIgw7u_KsQnbWrPUU3qzkI-r72Grz7kp4Fm32KkBqA/s1600/winner.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5580994204237950722" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiZ20IJBLu5ePEUKL0bwFA8RSyWPjKFQDm5YHVAcwwbU_9imWz6YVp8pp8QbDpSEoZ1F4TNzVfWia13tgGqFCynsMZviaTQuc2D5QfIgw7u_KsQnbWrPUU3qzkI-r72Grz7kp4Fm32KkBqA/s320/winner.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 360px; height: 270px;" /></a><span style="font-size:85%;">The ED EHR Slot Machine. Click to enlarge. You've hit the ED EHR mis-processing jackpot! Perhaps today is a good day to die...</span><br /></div><br />I do not believe mission critical software for, say, avionics, or for implantable medical devices, suffers such sloppiness. (In part due to regulation, <span style="font-weight: bold;">which health IT lacks entirely in the U.S.</span>).<br /><br />The UK, having their own HIT issues (see my Aug. 2010 "Battle of Britain" post <a href="http://hcrenewal.blogspot.com/2010/08/cerners-blitzkrieg-on-london-wheres-raf.html">at this link</a>), apparently learned something, as evidenced in:<br /><br /><span style="font-size:100%;"><a href="http://www.connectingforhealth.nhs.uk/engagement/clinical/occo/safety/dscn18.pdf"></a></span><blockquote><span style="font-size:100%;"><a href="http://www.connectingforhealth.nhs.uk/engagement/clinical/occo/safety/dscn18.pdf">Health informatics — Guidance on the management of clinical risk relating to the deployment and use of health software</a>. UK National Health Service, </span><span style="font-size:100%;">DSCN18 (2009), </span><span style="font-size:100%;">formerly ISO/TR 29322:2008(E).</span><span style="font-style: italic;font-size:100%;" ><br /><br /></span><span style="font-size:100%;">and</span><span style="font-style: italic;font-size:100%;" ><br /><br /></span><span style="font-size:100%;"> </span><span style="font-size:100%;"><a href="http://www.connectingforhealth.nhs.uk/engagement/clinical/occo/safety/dscn14.pdf">Health Informatics — Application of clinical risk management to the manufacture of health software</a>. </span><span style="font-size:100%;"> </span><span style="font-size:100%;">UK National Health Service, </span><span style="font-size:100%;">DSCN14 (2009)</span><span style="font-size:100%;">, formerly ISO/TS 29321:2008(E).</span></blockquote><br />That said, I will now comment in more detail on a part of the analysis readily understandable by 'database laypeople': part 2, <span style="font-weight: bold;">"Discussions with ED Directors: Are we on the right track?"</span> (again, probably a rhetorical question).<br /><br />In this section, candid discussions were held with the Directors of seven Emergency Departments in New South Wales public hospitals assessing the impact of the introduction of the FirstNet information system into their ED's. The effort has been ongoing for approximately the last 5 years.<br /><br />Numerous themes remind me of my own observations as in my aforementioned <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">Drexel health IT difficulties site</a>:<br /><br /><blockquote>The implementation processes of the HSS <span style="font-weight: bold; color: rgb(255, 0, 0); font-style: italic;">[governmental Health IT support, a.k.a. Health Support Services - ed.]</span> were criticised for <span style="font-weight: bold;">refusing to acknowledge the validity of complaints</span>, failing to fulfil promises, creating an <span style="font-weight: bold;">ineffective change process</span>,<span style="font-weight: bold;"> refusing to consult clinicians</span>, using strategies to <span style="font-weight: bold;">disenfranchise participation by clinical staff</span>, and introducing a technology that <span style="font-weight: bold;">doesnʼt fit their needs</span>.<br /><br /><br /></blockquote>All of these themes are familiar to me, and are representative of the phenomena of non-clinician, IT-centric arrogant ignorance, paternalism, leadership-pyramid inversion (i.e., the facilitators thinking and acting as if they are the enablers of healthcare), playing nasty politics with clinicians to avoid work, and minimizing job and results-evaluation discomfort for those lucky enough to secure cushy IT jobs in health IT support.<br /><br /><blockquote>In determining the clinical documentation needs of staff, the Directors claim that the HSS ignores the needs of staff. Directors report <span style="font-weight: bold;">over-supply of irrelevant information </span>and <span style="font-weight: bold;">under-supply of needed information</span> in the clinical interfaces. <span style="font-weight: bold; color: rgb(255, 0, 0); font-style: italic;">["Legible gibberish" - ed.] </span>The environment consists of <span style="font-weight: bold;">counter-intuitive interfaces</span> where data is entered by one person in one part of the system so that it is not discoverable by another person.<br /><br />The interfaces have <span style="font-weight: bold;">inappropriate sizing of objects, confusing functions, redundant steps, unused functions and cluttered interfaces</span>. These difficulties have resulted in <span style="font-weight: bold;">increased time usage</span> on the system resulting in <span style="font-weight: bold;">decreased time with patients</span> for<span style="font-weight: bold;"> no gain</span> in administrative or clinical outcomes. Staff minimise their use of the system to as little as possible with <span style="font-weight: bold;">work arounds </span>being constantly developed and improved. Staff morale has been clearly degraded with accompanying loss of respect for the HSS and more generally NSWHealth’s authority.<br /></blockquote><br />These concepts are described and illustrated in my multi-part essay on the healthcare IT <span style="font-weight: bold;">mission hostile user experience</span> <a href="http://www.tinyurl.com/hostileuserexper">at this link</a>. They represent major deviations from good information science, information presentation and human-computer interaction (HCI) precepts.<br /><br /><blockquote>... <span style="font-weight: bold;">Workarounds</span> in using the system are the most obvious tangible response of staff to the functions of the system they consider unsatisfactory. The key aspect of workarounds is that they constitute a subversion of the policy processes created by the software that the staff are not prepared to collaborate with. Some of these strategies may even <span style="font-weight: bold;">compromise the legal status of the records in the system</span>: such as not signing documents, unrecorded alterations to documents, and test results not attached to patient records.<br /><br />... Another form of staff protest workaround is the strategy by staff to avoid using the system by either having <span style="font-weight: bold;">other people <span style="color: rgb(255, 0, 0); font-style: italic;">[presumably underlings - ed.]</span> do the work on the system</span>, <span style="font-weight: bold;">inserting minimal amounts of information</span> thereby reducing the value of the information and passing information to other staff verbally.<br /></blockquote><br /><br />Workarounds to IT obstacle courses and booby traps, as noted by Koppel, Wetterneck, Telles & Karsh in <span style="font-weight: bold;">"</span><a style="font-weight: bold;" href="http://jamia.bmj.com/content/15/4/408.abstract">Workarounds to Barcode Medication Administration Systems: Their Occurrences, Causes and Threats to Patient Safety</a><span style="font-weight: bold;">"</span>, J Am Med Inform Assoc. 2008 Jul-Aug;15(4):408-23, increase, not reduce, the risk of EHR-mediated medical errors. I wrote about their findings at "<span style="font-style: italic;">Business v. clinical computing: Workarounds to Barcode Medication Administration Systems</span>" <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=barcoding">at this link</a>.<br /><br />It should be kept in mind that these are <span style="font-weight: bold;">mission-critical systems for use in a fast-paced ED,</span> not tracking systems for widgets - or for lab rats.<br /><br /><blockquote>The <span style="font-weight: bold;">lack of appropriate reporting functionality of the system has had a serious impact on the critical work of the Directors on process improvement</span> ... It was evident in talking to the Directors that they have antennae highly tuned to the processes happening in their departments and the public health issues that emerge from their patients.<br /><br />On a daily, weekly and monthly basis they review single cases, collections of common cases, and variations in established disease profiles to understand the success of their work and to detect emerging new trends or potential new disease outbreaks. At an administrative level they are asked to review cases either because of the return of new test results or due to complaints or reviews from other bodies.<br /><br /><span style="font-weight: bold;">The FirstNet installation has removed all the reporting functionality the directors had in their previous system EDIS while destroying their information sources for process improvement</span>, and their mechanisms for creating and collaborating in research projects. This, in turn, has led to a <span style="font-weight: bold;">loss of motivation</span> to enter data further degrading the value of the data held within the system.</blockquote><br />Reducing the value of a tool to people, and decreasing their ability to perform their jobs (especially when they take great professional responsibility and pride in those jobs) predictably leads to demoralization, demotivation and a cascading path down a whirlpool of failure.<br /><blockquote><br />The disadvantages of the system for day to day operations is well demonstrated by the <span style="font-weight: bold;">issues around the ordering system</span>. It is stated to be <span style="font-weight: bold;">overly complex</span> and requires a <span style="font-weight: bold;">large deal of repetitive information</span> to be input for multiple orders on one sample, plus specialist data entry knowledge that requires every joint order to have exactly the same timestamp. Ordering was the first accession where staff recognised that <span style="font-weight: bold;">information is sometimes sent to the wrong staff, both arriving where it shouldn’t and not arriving where it should.</span><br /><br />... Further mis-processing is seen with the cancellation of orders when a patient is transferred to a hospital ward from the ED. The results of orders, particularly radiology, often need to be checked by senior staff, but the system has no functionality to enable efficient processing of orders that have normal results, and thereby require no further attention.</blockquote><br />I do recall another EHR system, by the same vendor I believe, where an "upgrade" in the recent past led to orders ending up in the wrong places (<a href="http://hcrenewal.blogspot.com/2010/08/huffington-post-investigative-fund-fda.html">link</a>):<br /><br /><blockquote>... Computers at a major Midwest hospital chain went awry on June 29, posting some doctors’ orders to the wrong medical charts in a few cases and possibly putting patients in harm’s way.<br /><br />The digital records system “would switch to another patient record without the user directing it to do so,” said Stephen Shivinsky, vice-president for corporate communications at Trinity Health System<strong>. </strong>Trinity operates 46 hospitals, most in Michigan, Iowa and Ohio.<span style="font-weight: bold; color: rgb(255, 0, 0); font-style: italic;"><br /><br />[In other words, data entered by clinicians was going into the wrong charts. How many charts were involved? Does the hospital system even know, I wonder? - ed.]</span><br /><br />Less than two weeks later, an unrelated glitch caused Trinity to shut down its $400 million system for four hours at 10 hospitals in the network because<span style="font-weight: bold;"> electronic pharmacy orders weren’t being delivered to nurses for dispensing to patients</span>, he said.</blockquote><br />Not to pick on this vendor; these "glitches" seem to be occurring in many HIT vendor's products.<br /><br />All this, dear readers, is simply madness.<br /><blockquote><br />... Patient record retrieval is an important aspect of the staff work with patients, therefore its efficiency and accuracy is of vital importance to the activities of the ED. Staff were particularly pointed about the deterioration of this functionality in FirstNet compared to the previous system EDIS. <span style="font-weight: bold; color: rgb(255, 0, 0); font-style: italic;">[ED information system - ed.]</span> There were cases where <span style="font-weight: bold;">records could not be found</span>, confusion about <span style="font-weight: bold;">where data was stored in the patient record with different staff writing the same information into different parts of the record</span>, and the <span style="font-weight: bold; color: rgb(255, 0, 0); font-style: italic;">[manual] </span><span style="font-weight: bold;">rewriting of records</span> <span style="font-weight: bold; color: rgb(255, 0, 0); font-style: italic;">[requiring a large amount of additional labor and time, not exactly a commodity in an ED -ed.] </span>due to insertion of content into the wrong record.</blockquote><br />These are critical issues. If you can't get information out of a computer in a timely fashion, what you have is a <span style="font-style: italic;">very expensive doorstop</span>. I also note that a document imaging system that images hand written charts would not have these problems...<br /><br />Prof. Patrick addresses the oft-heard canard that such complaints are the complaints of "Luddite doctors", old dogs who simply don't want to learn new tricks:<br /><br /><blockquote>The staff in the ED are now generally experienced at using some form of clinical information system, many for over 10 years. This experience gives them a keen sense of what is possible with technology as well as the deficiencies in the existing systems. Combining this experience and knowledge with a sense of professional responsibility for process improvement enables them to judge quite acutely when a system is well designed or not. Hence their observations about elements of systems that are not parsimonious enough for optimal clinical efficiency <span style="font-weight: bold;">deserve to be respected.</span><br /></blockquote><br />That it <span style="font-style: italic;">even needs to be written</span> that the opinions of experienced medical professionals on the tools they are coerced to use by non-medical outsiders "<span style="font-weight: bold;">deserve to be respected" </span>gives testimony to my observation of a cross-disciplinary invasion of healthcare by the IT profession (among others).<br /><blockquote><br />Workflow and dataflow and the continuity of these processes are <span style="font-weight: bold;">vital to the smooth running of a complex socio-technical process</span>. ED staff have shaped these flows over a period of years and socialised all staff into the streaming. The directors have found that with the workflow of staff needing to use both clinical and nursing notes at the same time, <span style="font-weight: bold;">their separation in FirstNet is deleterious</span>. One department considered that the many nursing and medical notes accumulated over a day had to be kept in a single continuous sequence in the clinical record. Their workaround was to keep the one note page open for 24 hours to maintain the needed continuity in the patient record and avoid staff using a significant amount of time at the computer searching for needed information.<br /><br /></blockquote>Nemeth and Cook explain how an ED EHR can be developed and marketed that interferes with, not supports, the workflows common in ED"s worldwide, in "<a href="http://www.ctlab.org/documents/Hiding%20in%20plain%20sight.pdf">Hiding in plain sight: What Koppel et al. tell us about healthcare IT</a>", J Biomed Inform. 2005 Aug;38(4):262-3:<br /><blockquote><br />... On the surface, healthcare work seems to flow smoothly. That is because the clinicians who provide healthcare service <span style="font-weight: bold;">make it so</span>. Just beneath the apparently smooth-running operations is a <span style="font-weight: bold;">complex, poorly bounded, conflicted, highly variable, uncertain, and high-tempo work domain.</span> The technical work that clinicians perform resolves these complex and conflicting elements into a productive work domain. Occasional visitors to this setting <span style="font-weight: bold; color: rgb(255, 0, 0); font-style: italic;">[i.e., IT personnel, non-medical bureaucrats, etc. - ed.]</span> see the smooth surface that clinicians have created and remain unaware of the conflicts that lie beneath it.<br /><br />The technical work that clinicians perform is <span style="font-weight: bold;">hiding in plain sight</span>. <span style="font-weight: bold; color: rgb(255, 0, 0); font-style: italic;">[Hiding from the uninformed, that is - ed.]</span> Those who know how to do research in this domain can see through the smooth surface and understand its complex and challenging reality. Occasional visitors cannot fathom this demanding work, much less create IT systems to support it. <span style="font-weight: bold;">Progress in healthcare IT systems relies on scientific data on the actual, not the perceived, nature of day-today operations.</span></blockquote><br />It increasingly seems the only place the faux-expert, healthcare-facilitor, cybernetic snake oil salespeople are going ot learn this simple lesson is in the courtroom...<br /><br /><blockquote>A recent article in the press has presented evidence that access block times in EDs across the state of NSW are worsening.<br /></blockquote><br />As regards causality, it perhaps takes being an IS dept. director in a hospital - or holding elected office - to be unable to recognize the nose at the front of one's face.<br /><br />Prof. Patrick wraps up this section of his forensic analysis as follows:<br /><br /><blockquote>A number of conclusions can be drawn from the study:<br /><br />1. Staff are entirely dissatisfied with the SBB and they feel that the deliverables have significantly failed to match the promises.<br /><br />2. The Directors see that the HSS have failed in their support of the frontline of emergency care across the Sydney basin and their practices are decidedly lacking in proper engagement with the user community which should be their primary concern.<br /><br />3. Some of the consequences of the HSS decision not to provide the reports needed by the Directors have lead to them being seriously hampered in being able to monitor the quality of their own department’s practices and wider changes and trends in community health.<br /><br />4. The inefficiencies introduced by this technology have lead to a litany of complaints about its behaviour that have gone unheeded over the past three years.<br /><br />5. It has lead to major strategies to work around the system by staff at all levels, to the point of complete avoidance by some staff.<br /><br />The major consequences of these failings in the eyes of the ED directors are:<br /><ul><li>Lost productivity and inefficiencies,</li><li>Increased risks to patients,</li><li>Disillusionment of staff and loss of morale.</li></ul></blockquote>Considering my own relative's injuries originating in an ED EHR mishap, I think I can safely add to Prof. Patrick's final tally an additional item: <span style="font-weight: bold;"><br /></span><blockquote><ul><li><span style="font-weight: bold;">Patients have been harmed.</span><br /></li></ul></blockquote><span style="font-weight: bold;"></span>This is not a pretty picture.<br /><br />I'm confident the Australian legal system abhors negligence as much as our own here in the U.S. If patients are injured and/or die as a result, considering that the Programme leadership and IT vendors knew - or should have known - of these deficits, it would not surprise me if criminal negligence charges begin to appear.<br /><br />These issues are not exactly rocket science, and an expanding literature base has been appearing in recent years. See, for example, my recent post "<span style="font-weight: bold;">An Updated Reading List on Health IT</span>" <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">at this link</a>.<br /><br />I can only add that my own relative was nearly killed as a result of a number of the phenomena described in Prof. Patrick's analysis.<br /><br />More on other sections of his report at another time.<br /><br />-- SS<br /><br />March 6, 2011 <span style="font-weight: bold;">addendum</span>:<br /><br />Also see my new post "<a href="http://hcrenewal.blogspot.com/2011/03/what-to-do-about-state-of-ed-ehr-in-nsw.html"><span style="font-weight: bold;"></span>What to do about the state of the ED EHR in NSW?</a>"<br /><br />-- SS<br /><br /><span style="font-size:100%;">Mar. 8, 2011 <span style="font-weight: bold;">addendum:</span><br /><br />Prof. Patrick has added a new section to his report, entitled "<span style="font-weight: bold;">The Future Pathways for e-Health in NSW.</span>" It is available <a href="http://sydney.edu.au/engineering/it/%7Ehitru/essays/Things%20we%20should%20change%20in%20NSW-v4.pdf">at this link</a> (PDF).<br /><br />It inoculates against most of the 'Ten Plagues' that bedevil health IT projects (such as the IT-clinical leadership inversion, magical thinking about the technology, and lack of accountability):<br /><br />More on the Pathways at my post <a href="http://hcrenewal.blogspot.com/2011/03/future-pathways-for-e-health-in-nsw.html">here</a>.<br /><br />The de facto "National Program for IT in the HHS" here in the United States needs a similar inoculation.<br /><br />--SS</span>

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On an EMR Forensic Evaluation by Professor Jon Patrick from Down Under: More Thoughts.

Note: the reports to which this post refers are available as a set of PDF's from the University of Sydney, NSW, Australia at this link (12 Mb, .zip folder), or at "A study of an Enterprise Health info…

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