healthy4u: Siemens Healthcare

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

I believe in 2013 that they are. (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>) 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. <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> 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. Namely, the issue that enterprise electronic medical command-and-control systems, which today's "EHRs" in reality are, are on their face more risk-prone than the paper systems they are replacing. 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. 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. The workarounds also cause users to: 1)  have to deviate from habits of use acquired in training and active use of the systems in question; 2) remember, 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; 3) keep in mind any other extant workarounds that exist waiting for "fixes"; and 4) be constantly on guard for information storage failures. 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. See my Dec. 14, 2011 post "FDA Recalls Draeger Health IT Device Because This Product May Cause Serious Adverse Health Consequences, Including Death" (<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 "Health IT FDA Recall: Philips Xcelera Connect - Incomplete Information Arriving From Other Systems"(<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. 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. On the other hand, when electronic systems: 1)  lose modified information en masse as in the Siemens examples but keep the old, or 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 "Yet another health IT "glitch" affecting thousands" 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 3)  images are lost (see "Potential Image Loss in GE Centricity PACS" 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- - There are no "flags" that the obsolete, truncated or missing information is erroneous. What remains is perfectly legible, perfectly convincing and perfectly deceiving. 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. Paper does not suffer these issues, unless disappearing ink is used to cross out the old and add new information ... 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: 1)  a lot of Health Information Management professionals to perform continuous QA of paper, 2)  a lot of document imaging systems to make the paper records available anywhere, anytime they are needed, and 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>. 4)  a lot of sensible regulation of this industry's product quality. -- SS

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 recent...

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Can Digital Disappearing Ink (An EHR "Glitch") Kill Patients? Part 2

At "<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>" just yesterday, on August 5, 2013, I wrote about a Siemens EHR "glitch" worse than any paper records system problem.  Typed order changes in the medication reconciliation process on patient discharge are disappearing into thin air, unknown to the clinicians typing the orders.  This is likely due to an issue such as some programmer forgetting to put in a statement to write the text to disk, complicated by software testing problems that missed the defect. I noted: <blockquote class="tr_bq">... "<a href="http://hcrenewal.blogspot.com/search/label/glitch">Glitch</a>" is a banal term used by health IT extremists (those who have abandoned a rigorous scientific approach to these medical devices as well as basic patient protections, in favor of unwarranted and inappropriate overconfidence and hyper-enthusiasm).  The term is used to represent potentially injurious and lethal problems with health IT, usually related to inadequate software vetting and perhaps even "sweatshop floor in foreign country directly to production for U.S. hospital floors" development processes (this industry is entirely unregulated).</blockquote>  Paper records may have illegible writing that would generally cause the reader to make a phone call or otherwise contact the writer, but those events are one-offs.  EHR defects potentially affect hundreds of installations and thousands of patients, en masse.  (If patients are not dying en masse from such errors, then the whole argument against paper and for IT on the issue of vastly improved safety goes out the windows, but that's an argument for another time.) Siemens has just released another "glitch" announcement, this time with CPOE (computerized order entry): <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/AVvXsEhlf06mny1stnwAAlLHkyNdwsIaVZoVr4Ftj3MJ0gFspDqC1S8mEHtybkYsgnOntpI-v6uI4j8BUP-XAo0YeldipSlCT8MguHKKiDepn-YABtnVzVy9PpNTY5a43jQDrNAqV54fZYw9CAz1/s1600/Siemens_CPOE.bmp" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhlf06mny1stnwAAlLHkyNdwsIaVZoVr4Ftj3MJ0gFspDqC1S8mEHtybkYsgnOntpI-v6uI4j8BUP-XAo0YeldipSlCT8MguHKKiDepn-YABtnVzVy9PpNTY5a43jQDrNAqV54fZYw9CAz1/s400/Siemens_CPOE.bmp" width="307" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">(Medication orders "glictch" safety complaint.  Click to enlarge, text below)</td></tr></tbody></table> Text is as follows: <blockquote class="tr_bq">August 2, 2013 Safety Advisory Notification Soarian® Clinicals Medication Orders, Safety Complaint ID# EV06643783 Dear Customer: This notification is to inform you that the Soarian Clinicals Medication Orders may not be operating properly in some cases in Soarian Clinicals 3.3 Service Pack 6 and above.</blockquote> I note that "glitches" are not uncommon after software patches and upgrades.  See examples at the query link <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a>.   This reflects inadequate vetting of the patches. I also note that "medication orders not operating properly" is a very, very serious matter. <blockquote class="tr_bq">Although this may affect only some customers, we are taking a conservative approach and are alerting you to this potential problem. As such, please forward this notification to appropriate personnel as soon as possible.</blockquote> "May only affect some customers?" (I suspect from this double-indefinite that who is affected is not rigorously known).  "Taking a conservative approach?"  I ask:  what would a non-conservative approach entail? <blockquote class="tr_bq">This letter is being sent as a precautionary measure as there have been no adverse events reported from customers.</blockquote> Again, they mean "yet." When does this issue occur and what are the potential risks? <blockquote class="tr_bq">The issue occurs while placing medication orders. In certain cases, when users select orders from predefines or personal favorites and make changes on the order detail forms, the changes are correctly saved and displayed on the forms but the Order As Written (OAW) is not refreshed to reflect the changes. The incorrect OAW is displayed in Siemens Pharmacy in the Order As Written window but the discrete order details are correct. As a result dispensing or administering relying solely on the OAW prior to pharmacy validation may result in error.  [Putting patients directly in harm's way, patients who never consented to the use of these experimental and unvetted medical devices - ed.]  Once the order is validated the OAW in Soarian is updated correctly.</blockquote> This problem - manually changed data apparently not written to disk - seems similar to the "digital disappearing ink" med reconciliation bug in the aforementioned Aug. 5, 2013 post. Immediate steps you should take to avoid the potential risk of this issue: <blockquote class="tr_bq">To prevent this issue from occurring at your facility, dispensing or administering of unvalidated order should rely on the order details displayed. Secondly, any deviations from the predefined or personal favorites should be phoned in to pharmacy as a verbal order. During validation, if the pharmacist sees a discrepancy between the order detail and the OAW, verbal follow up with the ordering physician is required.</blockquote> Again, a workaround.  How many times will this workaround be forgotten, compared to issues of illegibility in a paper record resulting in a phone call to the writer? <blockquote class="tr_bq">Steps that Siemens is taking to correct this complaint: We are diligently working to develop a correction and will test and deliver it as soon as possible.</blockquote> Perhaps they should have been working more diligently to detect the "glitch" before it went live. Also, perhaps the touted power of EHRs to reduce medical errors needs to be re-examined.  Considering bugs like these - creating en-masse problems far worse than possible with paper (another en-masse example 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>) - then, if the EHRs are so essential to safety, one would expect significant morbidity and mortality from these defects. If one is to believe patients are not being injured by "glitches", then the expenditure of hundreds of billions of dollars for these systems on the basis of "error reduction" compared to paper is likely a waste of money and resources. --  SS

Can Digital Disappearing Ink (An EHR "Glitch") Kill Patients? Part 2

At " Another Health IT "Glitch" - Can Digital Disappearing Ink Kill Patients? " just yesterday, on August 5, 2013, I wro...

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

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

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

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

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Siemens Healthcare on solving EHR usability problems: you can just call up your pal at the next hospital

In my Aug. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/08/why-siemens-healthcare-fails.html">Why Siemens Healthcare Fails</a>", I wrote: <blockquote>I note that I used to admire German engineering rigor, but after seeing ill conceived, misguided position ads like the following from Siemens Healthcare, I am having sincere doubts about that country's current prowess in that domain.</blockquote> My admiration fell another notch. I now see this, in a Feb. 1, 2012 article from HealthData Management entitled "<a style="font-weight: bold;" href="http://www.healthdatamanagement.com/issues/20_2/user-unfriendly-43946-1.html">User Unfriendly</a>" on the flaws in commercial health IT that present a poor user interface/user experience (at the expense, ultimately, of you, the patient). The article's browser title bar somewhat subliminally reads "Physicians gripe that EHR's are not easy to use but improvements are coming": <blockquote> ... There's also no mechanism for publicizing problems with EHR interfaces, unlike the FDA's process for issues with medical devices. [User interface expert Prof. Ben] <a href="http://www.cs.umd.edu/%7Eben/">Shneiderman</a> describes a case where a physician found a bug in an EHR that created a danger to patients. "He contacted the supplier because he thought it was something other users should know about, and the response was, 'Oh, we know-we're working on it,'" Shneiderman says. "The physician said, What? You know about it and you haven't notified everyone?' Contrast that with the Federal Aviation Administration, where problems with airplanes are publicized within hours." The IOM report calls for substantial loosening of those contractual restrictions. "The committee views prohibition of the free exchange of information to be the most critical barrier to patient safety and transparency," the report says. "The committee urges the [HHS] Secretary to take vigorous steps to restrict contractual language that impedes public sharing of patient safety-related details. Contracts should be developed to allow explicitly for sharing of health I.T. issues related to patient safety." The report also says there should be a central place to report and publicize known issues with EHR software.</blockquote> Siemens apparently has a different idea on taking responsibility for the user interfaces of their products: <blockquote>Siemens Healthcare Chief Medical Officer Don Rucker, M.D., says the secrecy issue is overblown. "There are trailer loads of information out there on each of these big systems, and there are so many end users that you can just call up your pal at the next hospital."</blockquote> There are trailer loads of information out there, and it's up to the end user physician to find the information and sort through it? ... Sounds perfectly reasonable to me. /not/ There are so many end users that you can just call up your pal at the next hospital [for guidance on user interface complexities and errors]? Also sounds perfectly reasonable. /not/ ... Except, I think most EMR vendors and user-organizations sort-of disable Remote Assistance, Remote Desktop and similar programs. Even "print screen" is usually either disabled or forbidden from sharing with that "pal at the other hospital." Might have something to do with security and IP protection. Ever try to guide someone through a complex computer interface over the phone, blind, with no real-time mutually viewed visuals? It's not easy, but ... physicians and nurses have PLENTY of time for such fritter, what with the little other work they have to do. I also think saying busy physician, nurse and other clinical customers should "depend on their pals at the next hospital" for information on health IT difficulties is a rather condescending and patronizing statement to make (to be charitable), a backyard-mechanic attitude, but that's just me. Why does Siemens fail? This type of statement is a very good clue. -- SS

Siemens Healthcare on solving EHR usability problems: you can just call up your pal at the next hospital

In my Aug. 2009 post " Why Siemens Healthcare Fails ", I wrote: I note that I used to admire German engineering rigor, but after s...

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Lifespan (Rhode Island): Yet another health IT "glitch" affecting thousands - that, of course, caused no patient harm that they know of - yet

There's been yet another health IT "glitch" that, of course, caused no patients to be harmed. See other "glitches" <a href="http://hcrenewal.blogspot.com/2011/05/twelve-hour-health-it-glitch-at.html" style="font-weight: bold;">here</a>, <a href="http://hcrenewal.blogspot.com/2011/01/orderless-in-seattle-software-glitch.html" style="font-weight: bold;">here</a>, <a href="http://hcrenewal.blogspot.com/2010/03/will-it-take-luminosity-of-dozen.html" style="font-weight: bold;">here</a> and at other posts which can be found by searching this blog on the banal term 'glitch'. I note that when a clinician makes a mistake, it's called "malpractice." When health IT causes errors that can injure or kill, it's commonly referred with the banal, now-standard euphemism for computing malpractice: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjivTnAMIjZskLX87kQCR-LOWelEzDEUzupVGbOaKKCNKfoQe3kVzfxxERhVQOn9TIenOfKan-gR82Ogh9aqBulFgBlwHxLj2qCFmPiVm2j7sRFcyZRcO8vEFZfhsbqSGkn4802s3h9mfDF/s1600/glitch-mmo.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5671179020595590226" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjivTnAMIjZskLX87kQCR-LOWelEzDEUzupVGbOaKKCNKfoQe3kVzfxxERhVQOn9TIenOfKan-gR82Ogh9aqBulFgBlwHxLj2qCFmPiVm2j7sRFcyZRcO8vEFZfhsbqSGkn4802s3h9mfDF/s320/glitch-mmo.jpg" style="cursor: pointer; display: block; height: 90px; margin: 0px auto 10px; text-align: center; width: 180px;" /></a></div> Presenting the latest healthcare IT "glitch", affecting thousands: <blockquote><a href="http://www.wpri.com/dpp/news/local_news/providence/providence-rhode-island-state-senator-jamie-daniels-calls-for-review-of-lifespan-after-medical-errors">Computer glitch led patients to receive wrong meds</a> Senator calls for review of Lifespan WPRI.com (Providence, RI) Updated: Thursday, 03 Nov 2011, 5:47 AM EDT Published : Wednesday, 02 Nov 2011, 11:56 PM EDT Reported by Steve Nielsen PROVIDENCE, R.I. (WPRI) - Rhode Island State Senator Jamie Doyle says he is shocked to hear a <a href="http://www.lifespan.org/">Lifespan</a> computer glitch caused thousands of patients to receive the wrong types of medication. [Appx. 2,000 across five Lifespan hospitals according to the Providence Journal, see below, and the <a href="http://www.washingtonpost.com/business/ri-senator-wants-investigation-after-up-to-2000-hospital-patients-got-wrong-form-of-medicine/2011/11/03/gIQAufcviM_story.html">WaPo</a> - ed.] Doyle is now calling for an independent review of all the hospitals Lifespan runs, and a review of the Rhode Island Department of Health. The DOH is investigating after learning patients who were supposed to receive medications taken once a day instead received medications meant to be taken more than once per day.</blockquote> Health IT, of course, is unregulated by FDA or anyone, and vetted for safety only so far as the seller wishes to spend money on such tasks - which cuts their margins.  Ultimately, debugging is on live patients. <blockquote>[11/5/2011 note: As an anonymous commenter pointed out, the 2,000 or so errors at Lifespan should probably be multiplied by the number of organizations using the same software ---> "The entire country may have suffered 25,000-50,000 errors from this one glitch alone", the commenter astutely notes - ed.]</blockquote> Of course, the customary "we did feel lucky today, and the gun was empty" disclaimer follows: <blockquote>"Lifespan has not reported any adverse events or situations where patients required additional medications, but the information gathering and investigation is still ongoing," said DOH spokeswoman Annemarie Beardsworth.</blockquote> In other words, there could have been adverse events, we just at the Dept. of Health don't know yet with certainty, because none have been reported yet. <blockquote>In addition, some patients who were meant to get a medication with a coating did not receive a coating. The coating can help with stomach pains of other problems. "I just don't feel comfortable right now with some of the things that are coming out of there," Doyle said, "I really don't want to point fingers in any direction. but what we need to do is we need answers." Senator Doyle wants to have the review started in the next two to three weeks. </blockquote> Mr. Doyle, see my academic site on HIT failures <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">here</a> and an account of repercussions <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=diary">here</a> from an EHR-related medication error. <blockquote> Lifespan released the following statement Wednesday: "Lifespan is actively contacting 2,000 patients affected by this issue to ensure they receive the correct form of their medications. So far, we have reached out to more than 90 percent of the patients, many of whom were already taking the correct medication." Lifespan expects to finish contacting patients by Thursday.</blockquote> It will be interesting to understand the nature of this particular "glitch" and who the software vendor is. All it takes is a single "glitch" to seriously reduce a patient's lifespan. Siemens software may be involved. See this mutually self promoting, marketing-style Siemens document "<a href="http://www.medical.siemens.com/siemens/en_US/gg_hs_FBAs/files/IT_Solutions_And_Consulting/New_2009/09-06-25_NewportHospita_CaseStudy_A9133-9564-C1-4A00.pdf">Newport Hospital - a Lifespan Partner - At the Forefront of EMR Adoption</a>" (PDF), also cached <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/NewportHospital_CaseStudy.pdf">here</a>. (As an aside, one wonders if the hospital and/or its leadership received special financial or other "incentives" in allowing their name to be used in corporate promotions.) Also, Siemens was a company that apparently did not listen to an internal informatics specialist physician's concerns that their health IT for critical care was endangering patients (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=lawsuit">link</a>). They terminated the whistleblower. Also see my Aug. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/08/why-siemens-healthcare-fails.html">Why Siemens Healthcare Fails"</a> which I had emailed at the time to the Siemens Healthcare CEO Hermann Requardt. -- SS Nov. 4, 2011 addendum: Felice Fryer of the Providence Journal sent me a link to the story of Nov. 3, 2011 she wrote with a few more details, <a href="http://digital.olivesoftware.com/Olive/ODE/ProJo/LandingPage/LandingPage.aspx?href=VFBKLzIwMTEvMTEvMDM.&pageno=MQ..&entity=QXIwMDEwNA..&view=ZW50aXR5">here</a>. Excerpts: <div class="InfoComponentTextHedLine_hl1"></div><blockquote><div class="InfoComponentTextHedLine_hl1">Flaw found in hospitals’ prescriptions </div><div class="InfoComponentTextHedLine_hl2">Some patients discharged from Lifespan hospitals got right drugs in wrong form due to software error </div> <div class="InfoComponentTextByline">By FELICE J. FREYER JOURNAL MEDICAL WRITER </div> Some 2,000 patients of the Lifespan hospital group were discharged with incorrect prescriptions over the past 9 to 15 months because of a software glitch. [It took a year or more to discover these mounting errors? This is beyond the "red flag" warning signs I used to write about. This is crossing the chasm into the territory of "asking for catastrophe" - ed.] The prescriptions listed the right medications, but in the wrong form: people who were supposed to get time-release pills received prescriptions for short-acting ones. The error affected dozens of generic medications for a variety of conditions. Lifespan discovered the problem on Oct. 25 and had fixed the software by Friday, according to Dr. Mary Reich Cooper, Lifespan’s senior vice president and chief quality officer. The hospitals have placed calls to nearly all the affected patients, although not all have called back, Cooper said. Most patients reached had already obtained the correct medication because the error was noticed by someone at the hospital, or a pharmacist or doctor outside, she said. So far, Cooper said, there is no evidence that anyone was harmed. But Dr. Michael D. Fine, state Health Department director, said that the incident is an example of how electronic medical records, which normally help reduce errors, can sometimes amplify them by quickly affecting large numbers of people. “It’s the flip side of what has otherwise been a process that has improved accuracy and reliability,” he said. [I don't notice mention of a "flip side" to health IT in the aforementioned glossy hospital/IT company marketing brochure - ed.] The Health Department is investigating the incident. Fine also plans to examine whether the department should regulate the safety of electronic systems in health care. [Readers of this blog know my opinion on that matter - ed.] Asked whether he was worried there may be other as-yet-unrecognized software glitches, Fine said, “I’m reasonably concerned about the accuracy and integrity of electronic medical records.”... The software in question is not in use at other hospitals in Rhode Island, and the software vendor, Siemens, is notifying hospitals elsewhere in the country, according to Cooper. [In the interests of public health, I believe it incumbent on Siemens to make this "glitch" widely known not just to the hospitals but to the public in areas served by those hospitals, especially with the admission that "the (RI) hospitals have placed calls to nearly all the affected patients, although not all have called back." To not do so reflects negligence in my opinion - ed.] ... The errors arose from the process known as “medication reconciliation,” in which the physician compares the medications a patient was taking before hospitalization with those prescribed during hospitalization, and ensures that the patient goes home with a correct set of prescriptions. The Lifespan hospitals recently adopted an electronic system for this process. Doctors were correctly prescribing medication, and the prescriptions looked right on the computer screen, Cooper explained. But when printing out the prescription list, the software was cutting off a two-letter abbreviation that indicated certain medications should be in long-acting form or coated to protect the stomach. [As at Case 9 from FDA's MAUDE database at the post "<a href="http://hcrenewal.blogspot.com/2009/10/out-policy-is-to-always-have-unabashed.html">Our Policy Is To Always Have Unabashed Faith In The Computer</a>". Do these vendors robustly validate their products? The current errors, in fact, were only peripherally related to medication reconciliation. They were primarily related to computer errors impairing (sabotaging?) the clinicians. It would seem med recon now needs to include comparing what the doctor enters to what is output to the nurses and other healthcare personnel who provide written instructions to patients. Is such a task performable by healthcare personnel when the computer cannot be trusted? Further, do the doctrine of the "learned intermediary" and "hold vendor harmless" clauses seem appropriate here? - ed.] ... Cooper said the risk of harm from taking a short-acting medication instead of a long-acting one was “very, very minimal.” [Cooper misses the point, and IMHO such nihilistic attitudes have no place in healthcare - ed.] But Fine, the health director, said such mistakes “can be scary.” People taking medication for angina or high blood pressure would find their medication wearing off over the course of the day, putting them at risk of heart attack or stroke, he said. </blockquote> Medical errors that might seem innocuous or minor to health IT amateurs can prove catastrophic.  I've seen it happen, leading to injury and death. -- SS

Lifespan (Rhode Island): Yet another health IT "glitch" affecting thousands - that, of course, caused no patient harm that they know of - yet

There's been yet another health IT "glitch" that, of course, caused no patients to be harmed. See other "glitches"...

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A Lawsuit Over Healthcare IT Whistleblowing and Wrongful Discharge: Malin v. Siemens Healthcare

<div style="text-align: center;">"Any sufficiently advanced incompetence is indistinguishable from malice." - <a href="http://wikidumper.blogspot.com/2007/07/greys-law.html">Grey's law</a> </div> At an Aug. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/08/why-siemens-healthcare-fails.html">Why Siemens Healthcare Fails</a>" I described medical informatics talent management issues that were apparent in a job posting at <a href="http://www.medical.siemens.com/">Siemens Medical Solutions</a>, a company that a decade ago seemed to value medical informatics expertise. (They in fact wanted to hire me then, an offer former employees tell me I was fortunate to have rejected due to a better offer from pharma). I now note a July 2007 healthcare IT-related lawsuit against the same company (and its summary dismissal) of which I was unaware when I wrote the above post. A physician, Murray Malin, MD [note: I do not know this person and have never had contact with him - ed.], working for Siemen's medical IT subsidiary filed a July 2007 lawsuit for wrongful termination after raising safety issues with Siemens HIT designed for critical care. The action initially began in late 2005 as a complaint against Siemens Health Services USA and Siemens Medical USA (which I shall refer to in this post as "Siemens Medical" for the sake of simplicity) to the Occupational Safety and Health Administration (OSHA) of the Department of Labor. This was done under the whistleblower protection provisions of Title VIII of the Sarbanes-Oxley Act of 2002 (SOX). The OSHA complaint was followed by a pro se lawsuit in federal court. The lawsuit's specifics are covered in the following four court documents (PDF). The events described could quite possibly serve as a true poster example of all that's wrong in the too-often perverse world of health IT. Sen. Grassley, <a href="http://hcrenewal.blogspot.com/2010/01/grassley-asks-hospitals-about.html">take note</a>. Here are the court documents: <blockquote>1. The Complaint: <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/siemens/Complaint_Malin_vs_siemens_medical.pdf">Complaint_Malin_vs_siemens_medical.pdf</a> (3.3 Mb PDF) 2. Siemens Answer to Complaint: <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/siemens/Complaint_answer_Malin_vs_siemens_medicl.pdf">Complaint_answer_Malin_vs_siemens_medical.pdf</a> (148 Kb PDF) 3. Memorandum Opinion: <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/siemens/Memorandum_opinion_Malin_vs_siemens_medical.pdf">Memorandum_opinion_Malin_vs_siemens_medical.pdf</a> (22 Kb PDF) 4. Judge Messitte opinion, US District Court Maryland: <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/siemens/MalinvSiemensMedicalOpinion&Order07cv1896.pdf">MalinvSiemensMedicalOpinion&Order07cv1896.pdf</a> (97 Kb PDF) </blockquote> (I have written about health IT problems extensively on this blog and at my <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/medinfo.htm">academic website on HIT failure</a>. These include but are not limited to: medical informatics specialists <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU">ignored by nonclinician IT personnel</a> [the link is to another case involving critical care]; inverted and paradoxical organizational structures where IT facilitators become HIT project leaders and clinical leaders become HIT project facilitators; ill-conceived and poorly implemented <a href="http://www.tinyurl.com/hostileuserexper">mission hostile health IT</a>; perverse and in fact <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story">clinically cavalier IT "politics"</a>; failure to obtain <a href="http://hcrenewal.blogspot.com/2009/03/draft-patient-rights-statement-and.html">patient informed consent</a> as if health IT is an elite world not subject to the same ethical obligations as medicine; probable <a href="http://hcrenewal.blogspot.com/2009/03/health-it-hold-harmless-and-defects-gag.html">violations of Joint Commission safety standards and hospital executive fiduciary obligations</a>, and numerous others.) Here is a synopsis of why I think this 2007 lawsuit against Siemens Medical may be a sentinel case with regard to dysfunction in the healthcare IT industry, based upon the information in the court documents (read them yourself at the links above): <ul style="text-align: left;"><li>Siemens Medical's physician internal consultants (skilled anesthesiologists/informatics specialists), apparently in writing and including a remediation plan, opined that an IT system developed for critical care had numerous severe flaws, of sufficient seriousness that in their opinion the systems could harm or even kill patients if deployed;</li></ul><ul style="text-align: left;"><li>These were warnings of defects and flaws in IT in the worst possible medical environment, critical care with the sickest and most vulnerable of patients, not some ambulatory clinic or primary care office; </li></ul><ul style="text-align: left;"><li>Allegations were raised that the warnings were ignored, with at least one of the physicians, Dr. Malin, who was strongly concerned and vocal about the risks then being told his position was being eliminated. [It is not a surprise to note this rings alarm bells about the possibility of wrongful discharge based on retaliation and/or "greasing the skids" to eliminate potential whistleblowers or "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/informaticsmd/tactics.htm#team">non-team players</a>" who could delay release of the software and affect revenue - ed.]; </li></ul><ul style="text-align: left;"><li>The company possibly ignored the remediation plans of their own clinician/informatics experts;</li></ul><ul style="text-align: left;"><li>There were allegations of company misrepresentations about the new system to the FDA;</li></ul><ul style="text-align: left;"><li>There were allegations of decision making on these issues by non-clinician IT managers lacking healthcare or healthcare informatics expertise.</li></ul><ul style="text-align: left;"><li>A wrongful discharge complaint and then lawsuit were filed by Dr. Malin on the basis of violation of the whistleblower protection provisions of the Sarbanes-Oxley Act of 2002 (SOX), <a href="http://www.law.cornell.edu/uscode/18/usc_sec_18_00001514---A000-.html">18 U.S.C. § 1514A</a> ("Civil action to protect against retaliation in fraud cases - Whistleblower Protection for Employees of Publicly Traded Companies"); </li></ul><ul style="text-align: left;"><li>The suit was dismissed on the apparent technicality that Siemens Medical in the U.S. is not subject to the provision in the SOX Act as is the publicly-traded corporate parent, <a href="http://w1.siemens.com/">Siemens AG</a>; from document #4, pg 15: </li></ul><blockquote style="font-style: italic;">... Health Services is a wholly-owned subsidiary of Siemens Med ... Siemens Med is a wholly-owned subsidiary of Siemens Corporation, which is indirectly owned, through two intervening layers, by Siemens AG, a German company that is publicly traded as defined by § 1514A of SOX ... Of these entities, only Siemens AG is a publicly-traded company. While both Health Services and Siemens Med are incorporated in Delaware and located in Malvern, Pennsylvania, they are separately incorporated entities. </blockquote><ul style="text-align: left;"><li>Siemens Medical in their response to the suit denied the most severe allegations regarding the IT defects, but this issue was not followed up upon due to the lawsuit's dismissal on SOX issues despite the obvious potential public hazards the allegations of IT defects could represent;</li></ul><ul><li>In fact a US District Judge in the case, Peter J. Messitte, in the period after allowing Malin to prove the validity of SOX towards his case, opined that "No other discovery will be permitted, including but not limited to the alleged safety problems of Defendants’ product", document 4 above, Judge Messitte opinion, US District Court Maryland, pg. 25. [While perhaps understandable from a legal perspective, injured or dead patients don't really care about what legal precedents got them into the injured or dead state - ed.] </li></ul><ul style="text-align: left;"><li>Siemens Medical admitted in their responses to the suit that some of the software in question, actually put in use in hospitals, was in fact "beta" software, i.e., experimental (per Item 38 in 'Siemens Answer to Complaint' document).</li></ul> This latter admission also raises numerous questions. The answering of these questions seems imperative on the grounds of public interest in a rigorous and safe healthcare IT industry, an industry that, in effect <a href="http://histalk2.com/2010/02/01/readers-write-2110/">practicing medicine by machine proxy</a>, should respect patient rights and the Hippocratic Oath: <ul style="text-align: left;"><li>Were patients asked to give informed consent for the beta software's usage in their critical care?</li></ul><ul style="text-align: left;"><li>Were clinicians informed of the fact that the software was experimental?</li></ul><ul style="text-align: left;"><li>Were "hold harmless" clauses demanded from the customers?</li></ul><ul style="text-align: left;"><li>Did hospital executives violate their fiduciary and Joint Commission safety standards obligations by purchasing this beta software, either willfully, or inadvertently due to Siemens' possible concealment of the defects their own specialists wrote up?</li></ul><ul style="text-align: left;"><li>Would the use of beta-version software in critical care areas with possible known defects represent a human rights violation? </li></ul> What is not clear in these court documents is whether any patient harm was attributed to these HIT systems. This is not the important issue, however. The issue is risk and risk mitigation through rigor. One should not depend on good fortune to avoid predictable patient harm, especially when those predictions are from internal experts and are explicit. I therefore believe that the potential HIT safety issues raised in this case and the vendor's responses to internal warnings merit further investigation, especially regarding the specialist's concerns about the harmful defects in the software. These medical concerns and whether they were improperly dismissed were apparently never investigated impartially, due to the lawsuit's rejection by the court on technical grounds of SOX inapplicability. See the attached court documents. It is my personal opinion upon reading these court documents, and knowing this industry, that Dr. Malin was shafted. What is legal is not always just. One can only wonder how many other cases like this exist v. Siemens or other healthcare IT vendors. Perhaps the investigation being conducted by Sen. Grassley will shed more light on this. Finally, I note with sad irony, if these allegations are true, the doppelganger of a German-named company dismissing the concerns of an apparently Jewish physician about medical experiments possibly killing people. -- SS

A Lawsuit Over Healthcare IT Whistleblowing and Wrongful Discharge: Malin v. Siemens Healthcare

" Any sufficiently advanced incompetence is indistinguishable from malice. " - Grey's law At an Aug. 2009 post " Why Si...

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Why Siemens Healthcare Fails

I have written <a href="http://hcrenewal.blogspot.com/search?q=don%27t+need+informatics">numerous times on this blog</a> about the blind-man ignorance displayed by many healthcare IT and biomedical companies regarding Medical Informatics expertise. As a graduate and postdoctoral-level <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases">Medical Informatics educator</a> with considerable applied expertise, as well as talent management experience, I teach students of a variety of healthcare backgrounds that the only way to overcome the sociotechnical complexities (i.e., issues at the intersection of people and their interaction with technology) of HIT is via education and considerable experience. Once students become aware of the nuances and complexities of HIT in real-world clinical settings (if not already enmeshed in such environments), they find the lessons learned from substantial and rigorous immersion into a wide corpus of literature, overseen by someone with expertise, profoundly important towards advising their own organizations in avoiding pitfalls and achieving success. I note that I used to admire German engineering rigor, but after seeing ill conceived, misguided position ads like the following from Siemens Healthcare, I am having sincere doubts about that country's current prowess in that domain. I refer to a recent ad (<a href="https://careers.peopleclick.com/careerscp/client_siemens/external/jobDetails.do?functionName=getJobDetail&jobPostId=288315&localeCode=en-us&source=Indeed&sourceType=PREMIUM_POST_SITE">here</a> at the moment) for a Physician Consultant: <blockquote>Job Description Siemens Medical Solutions is the industry leader in Healthcare IT technology and Clinical workflow solutions. We are seeking to hire an experienced Physician for our Professional Consulting Services Organization. In this highly visibly position, you will support the implementation of Siemens products (such as Soarian ) in hospitals nationwide. To be considered for this position, qualified candidates must have the following credentials and experience: • U.S. based Medical degree with at least five years of post-residency experience in large multi-specialty practice or hospital-based facility in the United States. • Currently practicing medicine, or must have practiced at least 1 week per month within the last 3 years • Leadership experience with at least one CPOE implementation in a large, multi-facility health system, Integrated Delivery Network (IDN) setting • Extensive public-speaking and executive presentation experience • Medical informatics credentials or advanced degree preferred, but not required [Medical Informatics not required? - ed.] • Prefer some experience in public-health related projects</blockquote> Here are the obvious major problems: One CPOE implementation or even several does not by any means qualify a person to counsel other medical organizations and clinicians as a representative of a company citing itself as "the industry leader in Healthcare IT technology." Further, the criteria "Medical informatics credentials or advanced degree preferred, but not required" suggests the crafters knows little about Medical Informatics, or hold it at a low level of esteem, considering it an optional "gift" that might add slight extra value to the incumbent's ability to travel the country and give good advice and support in clinical IT implementation. What might substitute for such knowledge and expertise? This J.D. might better be described as "glorified salesperson." It might be a good exit route for a "techie doc" (usually, someone who knows just enough about HIT to be destructive) who hates the current practice environment. It might also be good for managers who don't want knowledgeable experts pointing out their bad decisions and mismanagement, but I think a global company like Siemens should be setting its sights higher in such a crucial area as electronic medical records and clinical IT consultants. I would not want such a physician advising or supporting complex HIT projects at my organization. I spent time at Siemens Healthcare headquarters in Erlangen in 2000, and was offered gracious hospitality and a position overseeing the Soarian cardiology suite. The people I met in Erlangen then seemed extremely competent and informatics-savvy, but I turned the offer down through no fault of Siemens. I'd received a near-simultaneous offer (FAXed to my hotel in Erlangen, in fact) from pharma that involved a much stronger management role. I understand through conversations over the past few years with current and ex-Siemens personnel that most of the Siemens personnel I'd met in Germany in 2000 are no longer with the company. I was told they'd performed suboptimally after the acquisition/merger with Shared Medical Systems (SMS) in Malvern, PA. (I do not find that credible, and would find it far easier to accept that the problems were on the American side, but that is a personal opinion.) Questions raised by these observations: <ul><li>What manner of ideology about education and expertise does this job description represent?</li></ul><ul><li>Is there nobody left in Germany with a realistic sense of the education and expertise required to advise on and support HIT implementations in a competent manner, I ask? </li></ul> Allow me to answer question #1. It represents the IT designer-centric, data processing and <a href="http://hcrenewal.blogspot.com/2008/05/seedie-society-for-exorbitantly.html">tabulator punch card culture-based</a> (and antithetical to medicine and science) view that with enough generalists and sufficient "process", any problem can be solved. By this logic, Bach and Beethoven would have had symphonies written for them by low level musicians in the name of "efficiency" and cost savings. <div style="TEXT-ALIGN: center"><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEix2PJZV6Lvz941B1K1MCZDOWpErm3UXImudOHfJVWl5yuX37hFPCy8cN8OlzhDqFnkSyN-g1ERPUCryj_HrM6HT1IB7bHzS5IowuLcYMSWtcAJMDZ-Loyp9s2R8SDwrUijd9Yq2ZqICcv1/s1600-h/Beethoven.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5373145108395395298" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEix2PJZV6Lvz941B1K1MCZDOWpErm3UXImudOHfJVWl5yuX37hFPCy8cN8OlzhDqFnkSyN-g1ERPUCryj_HrM6HT1IB7bHzS5IowuLcYMSWtcAJMDZ-Loyp9s2R8SDwrUijd9Yq2ZqICcv1/s320/Beethoven.jpg" style="DISPLAY: block; MARGIN: 0px auto 10px; WIDTH: 129px; CURSOR: pointer; HEIGHT: 156px; TEXT-ALIGN: center" /></a> Wanted: consultants to write my Ninth Symphony, according to the Acme Symphony-Writing Process Manual. Musical experience not essential. Must be team players. </div> Shareholders, take note. I emailed this post to the Siemens Healthcare CEO Hermann Requardt, who I note (almost predictably) <a href="http://w1.siemens.com/about/en/management-structure.htm">lacks a biomedical background</a> other than having been a research assistant for aviation medicine once, and having worked on MRI: <div class="p clearfix"></div><blockquote><div class="p clearfix">Education </div><div class="list"><ul class="bullet-list-orange"><li>Secondary school (baccalaureate)</li><li>Studied physics at the Technical University of Darmstadt and University of Frankfurt (Dr. phil. nat., Dipl.-Phys.)</li></ul></div></blockquote><div class="list"> A lack of response is therefore not surprising. </div>-- SS

Why Siemens Healthcare Fails

I have written numerous times on this blog about the blind-man ignorance displayed by many healthcare IT and biomedical companies regarding...

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