healthy4u: Siemens

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 wrote about a Siemens EHR "glitch" worse than any paper records system problem. Type…

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06 Aug 2013

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/glitch for more examples)."Glitch" is a banal term used by health IT extremists …

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05 Aug 2013

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 lawAt an Aug. 2009 post "Why Siemens Healthcare Fails" I described medical informatics talent management issues tha…

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07 Feb 2010

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