healthy4u: ecri institute

In ECRI Institute's new 2014 "Top 10 Patient Safety Concerns for Healthcare Organizations", Healthcare IT is #1. (FDA: E-cigarettes are REALLY dangerous.)

The ECRI Institute in Pennsylvania (<a href="https://www.ecri.org/About/Pages/default.aspx">https://www.ecri.org/About/Pages/default.aspx</a>) has had health IT as among the "Top Ten Healthcare Technology Risks" for several years running.  Search this blog on "ECRI" for mention of those reports. Just off the press, though, is ECRI's "Top Ten patient safety concerns for 2014".  The PDF report is available at <a href="https://www.ecri.org/EmailResources/PSRQ/Top10/Top10PSRQ.pdf">https://www.ecri.org/EmailResources/PSRQ/Top10/Top10PSRQ.pdf</a>. Health IT is number one, perhaps as a result of the ECRI Deep Dive study of Health IT risk with its hair-raising numbers of 171 "IT incidents", 8 resultant injuries, and 3 possible deaths in 36 hospitals in just 9 weeks (<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>). From the new report: CONCERN #1: Data integrity failures with health information technology systems <div>At page 7:</div><div> <div style="font-family: serif; margin-left: 40px;">With the federal government offering financial incentives for hospitals and physician practices to adopt EHR systems, use of these systems more than tripled from 2009 through 2012. “Health IT systems are very complex,” says James P. Keller, M.S., vice president, technology evaluation and safety, ECRI Institute. “They are managing a lot of information, and it’s easy to get something wrong” if the systems are not designed and implemented well. While appropriately designed and implemented systems can provide complete, current, and accurate patient care information so that the clinician can make appropriate treatment decisions, the presence of incorrect data can lead to incorrect treatment, potentially leading to patient harm.</div> <div style="font-family: serif; margin-left: 40px;">For example, the integrity of data in health IT systems can be compromised from any of the following: data entry errors, missing data or delayed data delivery, inappropriate use of default values, copying and pasting older information into a new report, use of both paper and electronic systems for patient care, and patient/data association errors (i.e., patient data from a medical device is mistakenly associated with another patient’s record). Key steps in safeguarding the integrity of electronic patient data include the following:</div><div dir="ltr" style="font-family: serif; font-size: 16.6667px;"> <div style="font-family: serif; margin-left: 40px;"> </div><div style="font-family: serif; margin-left: 40px;">x  Assessing the clinical workflow to understand how the data is, or will be, used by frontline staff  x  Testing the system and the associated interfaces, preferably in a simulated setting, to verify that the system is functioning as intended x  Providing sufficient user training and support x  Establishing a mechanism for users to report problems as they are discovered </div></div></div>In the Bizarro world in which we find ourselves in 2014, however: <ul><li>FDA has decided that healthcare information technology systems "for health information and data management" (I quote) are of "sufficiently low risk", even if they "meet the statutory requirements as medical devices" and thus fall under the Food, Drug & Cosmetic Act, to not require FDA oversight, and even though FDA admits they really do not and cannot know the true level of risks (<a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html">http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html</a>).  </li></ul>(Got that?) While: <ul><li>Regulation of E-cigarettes is a National Priority of the Highest Importance due to Their Possible Deadly Dangers (<a href="http://hcrenewal.blogspot.com/2014/04/hypocrisy-at-fda-lets-regulate.html">http://hcrenewal.blogspot.com/2014/04/hypocrisy-at-fda-lets-regulate.html</a>).</li></ul>The E-cigarette focus is For The Children, no doubt. <ul><li>Except for children such as these, one might conclude:  <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html</a>.</li></ul> <ul> </ul> <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/AVvXsEh0BV8P-O5io5HPCOYJHdjddYwVGrOt4Fj_vfeeLDGHu1cvrn3-1iryc-KRA_e-toY6ak2nFKFtijMIOvXB0W2PE8xMQe8IX6Pbbs42QmR4cTSR9swsk-IG3i371ljixE3-GSUn7QbQXzqZ/s1600/bizzaroworld.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh0BV8P-O5io5HPCOYJHdjddYwVGrOt4Fj_vfeeLDGHu1cvrn3-1iryc-KRA_e-toY6ak2nFKFtijMIOvXB0W2PE8xMQe8IX6Pbbs42QmR4cTSR9swsk-IG3i371ljixE3-GSUn7QbQXzqZ/s1600/bizzaroworld.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Bizarro World (<a href="http://en.wikipedia.org/wiki/Bizarro_World">http://en.wikipedia.org/wiki/Bizarro_World</a>).</td></tr></tbody></table> Note that ECRI Concerns #2 and #3 also may involve electronic medical records systems. CONCERN #2: Poor Care Coordination with Patient’s Next Level of Care (page 8): <blockquote>... Electronic health records (EHRs) can facilitate communication about a patient’s care among providers, but organizations must establish procedures that address accessing, reviewing, and acting on the findings in those records. For example, what happens if a provider who is viewing a patient’s record discovers that results of tests ordered by another provider have not been acted upon? EHRs could become a barrier “if physicians are second-guessing one another,” says Possanza. Organizations might find it helpful to develop a policy specifying procedures for a provider who finds an abnormal laboratory or pathology result with no indication that the abnormal result was acted upon.</blockquote><ul></ul> CONCERN #3: Test Results Reporting Errors (page 10): <blockquote class="tr_bq">... Callahan observes that breakdowns in test results reporting, particularly in physician practices, typically have one of three causes or a combination of them: (1) technology limitations, such as an inadequate interface between an EHR system and a laboratory system that provides the results electronically; (2) provider-to-provider communication gaps, such as those that occur when no backup plan is in place to designate a provider to review test results for another provider who is unavailable or on vacation; and (3) staffing and training failures, such as requiring a staff member to periodically check an EHR system for test results but not informing the person of what to expect in terms of the volume of test results typically reported to the practice. As more healthcare organizations adopt EHR systems, Callahan warns against being lulled into thinking the systems are a panacea and can prevent test reporting failures. “It’s another tool,” she says. “It won’t improve test results reporting if it’s not used correctly.”</blockquote> I was involved as consultant in a related scenario, in a case that settled out of court, where an ordered lab test was never performed (probably due to an EHR-lab interface failure!) and automatically "expired" in the EHR after a year.  However, no subsequent provider acted upon the expired order, with disastrous results. -- SS

In ECRI Institute's new 2014 "Top 10 Patient Safety Concerns for Healthcare Organizations", Healthcare IT is #1. (FDA: E-cigarettes are REALLY dangerous.)

The ECRI Institute in Pennsylvania (https://www.ecri.org/About/Pages/default.aspx) has had health IT as among the "Top Ten Healthcare Technology Risks" for several years running. Search this blog on …

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27 Apr 2014

"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 needs to be said about government, computing and healthcare" 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>. 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: <blockquote class="tr_bq">Bad Health IT ("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 hypervigilance (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.  </blockquote> At my Oct. 20, 2010 post "Medical center has more than 6000 'issues' with Cerner CPOE system in four months - has patient harm resulted?" (<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: <blockquote class="tr_bq">From the October 2010 "News for Physicians affiliated with Munson Medical Center" newsletter, a large medical center in Northern Michigan, about more than six thousand "issues" with their Cerner CPOE. ... 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> "likely to cause patient harm in short term if uncorrected" or "may cause in patient harm in medium or long term." I note that Cerner CPOE is not a new product, nor are similar products from other vendors also afflicted with long lists of "issues." 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> Here's another such multi-"issue"-laden EHR, this at University of Arizona Health Network.  Image of frequent periodic "EHR Update" below. <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> [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.] The text starts: <blockquote class="tr_bq">ISSUES UPDATE as of 4:00 p.m., Nov. 8 We’ve resolved 6,036 issues and have 3,517 open issues.</blockquote> 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>. 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. 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: <ul></ul><blockquote class="tr_bq"><ul><li>Pharmacy Medication Mapping Errors – Making good progress: watch for further notices.  [Perhaps these should have been tested and fixed before go-live? - ed.]</li></ul><ul><li>Microbiology Results Mapping Incorrectly [does that mean "mapping" to the wrong patient? - ed.]  – all known errors fixed, monitoring and working on enhancements. [As above, perhaps these should have been tested and fixed before go-live? - ed.]</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. [Not sure why this is being done; perhaps for approval by managers? - ed.]  </li></ul><ul><li>Errors transmitting prescriptions will also be sent to the CLIN SUPPORT In Basket.  [Errors transmitting prescriptions? That's not reassuring regarding data integrity.  See ECRI report below  - ed.]</li></ul></blockquote><ul></ul> This is not to mention that all of the "reminders" that follow are a distraction to clinical personnel, who cannot be expected to remember all of them. Bad as this is, at my April 1, 2012 post "University of Arizona Medical Center, $10 million in the red in operations, to spend $100M on new EHR system" (<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: <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> 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 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."  I observed the following about the "words that work" is the shameless 'suggested' script: <blockquote class="tr_bq">• Efficient - 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> • Convenient - as above.  According to whom?  Compared to what?  Pen and paper? • Improves patient safety and quality - 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 are only now studying safety of this technology, and the results are not looking entirely convincing, e.g. ECRI Deep Dive Study 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. • The Cadillac of its kind - according to whom? • Patients at hospitals using this system love it -  Do most patients even know what it, or any EHR, looks like?  Have they provided informed consent to its use? • Exciting - 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. • The best thing for our patients - again, according to whom? • Sophisticated new system - "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> Considering the near 10,000 issues, the new ECRI Institute report "Top Ten Technology Hazards in Healthcare", 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 healthcare IT.  This year's problem description is: <blockquote class="tr_bq">#4. Data Integrity Failures in EHRs and other Health IT Systems</blockquote> "Data integrity failures" include "issues" (per the bad health IT description) such as: data loss, data corruption, data attributed to the wrong patient, etc. <blockquote class="tr_bq"> 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> 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. 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. 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. If (when) patient harm results from such cavalier hospital (mis)management, the juries are going to just love the dark sunglasses, I bet. -- 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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09 Nov 2013

More Perversity on Health IT Risks, and ... EHR Sense from Nurses on "Nurse Talk", a Syndicated Radio Show

As I mentioned on July 2 <a href="http://hcrenewal.blogspot.com/2013/07/is-oncs-definition-of-significant-ehr.html">at this post</a>, in a June 25, 2013 Bloomberg News article "<a href="http://www.bloomberg.com/news/2013-06-25/digital-health-records-risks-emerge-as-deaths-blamed-on-systems.html">Digital Health Records’ Risks Emerge as Deaths Blamed on Systems</a>" by technology reporter Jordan Robertson an EHR-harms case in which I am (unfortunately) intimately involved as substitute plaintiff is mentioned: that of the death of my mother. I'd previously written about EHR-related electronic encounters with truly perverse individuals at my Jan. 2010 post "More on Perversity in the Healthcare IT World: Is Meditech Employing Sockpuppets?" at <a href="http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html">http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html</a>. There were quite a few thoughtful comments in the reader comments of the June 25, 2013 Bloomberg article, but also the typical callous, incompetent and/or bizarre comments that an anonymous forum invites (really, semi-anonymous, as the website tracks IP's of commenters).  The anonymous comment below stood out from the rest as a worst-case example of perverse defense of health IT (it may have been removed by now): <blockquote class="tr_bq">Pharm Aid 1 week ago I'm surprised at the poor quality of reporting in this article.  First, Scot Silverstein has been on jihad against electronic medical records LONG before his dear mother passed away in 2011.  According to Silverstein's own website, he opposed EMRs back as far as 2009. Second, the article fails to mention Silverstein's conflict of interest here - he works in this space.  Essentially, Silverstein contacts a vendor of EMRs, offers his "consulting" services.  This totally smacks of a shakedown to me.  If they don't hire him, he criticizes them and claims they are killing people.  Don't take my word for it, check out his website and blog. Third, the number of medical errors from paper-based records is staggering.  According to a study from 7 years ago, a staggering number - 23% - of patients at one health system had medication errors attributed to illegible paper-based charts.  This is roughly consistent with other studies, including the epic IOM report on errors in medicine.</blockquote> Let me point out the perversities.  I am assuming the comment was not simply deliberately false character assassination and that the writer believed what he/she was writing - which if not, would show the industry's cheerleaders in an even worse light than if the assumption is the poster believes what he/she wrote: <ul><li>No expression of sympathy or remorse at my mother's death, whatever the cause.</li></ul><ul><li>Gross and almost humorously silly caricature of my "consulting" (which is as expert witness) and defamatory comments.</li></ul><ul><li>Gross mischaracterization of this blog and my Drexel Univ. healthcare informatics teaching site at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases">http://www.ischool.drexel.edu/faculty/ssilverstein/cases</a>.</li></ul><ul><li>A mysterious invocation of some unnamed article on paper records at one health system.   I note that N=1 for both the mysterious unnamed study and its subject institution, representing the absolute worst regarding drawing conclusions, especially conclusions that we need to spend hundreds of billions of healthcare dollars on what today is largely bad health IT (see definitions of good and bad health IT at the aforementioned Drexel site).</li></ul><ul><li>An apparent mischaracterization of the "epic" 1999 IOM report "To Err is Human"on errors in medicine (<a href="http://www.iom.edu/~/media/Files/Report%20Files/1999/To-Err-is-Human/To%20Err%20is%20Human%201999%20%20report%20brief.pdf">http://www.iom.edu/~/media/Files/Report%20Files/1999/To-Err-is-Human/To%20Err%20is%20Human%201999%20%20report%20brief.pdf</a>).  It's clear that many if not most medical errors have nothing whatsoever to do with documentation, either paper or electronic (I made that point at my Dec. 2010 post "Is health IT the solution to the wrong problem?" at <a href="http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html">http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html</a>).  From that 1999 IOM report's summary:</li></ul><blockquote class="tr_bq">... Among the problems that commonly occur during the course of providing health care are adverse drug events and improper transfusions, surgical injuries and wrong-site surgery, suicides, restraint-related injuries or death, falls, burns, pressure ulcers, and mistaken patient identities. </blockquote><ul><li> As to "[my] claims that EHRs are [injuring and] killing people", I merely report what others find - that still others deliberately dismiss (e.g., as "anecdotal") - or ignore. Just the latest example is the ECRI Deep Dive study (<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 information technology-related problems voluntarily reported during a nine-week period to the ECRI Institute PSO from just 36 hospitals.  Eight of the incidents reported involved patient harm, and three may have contributed to patient deaths, said the institute.  Other examples appear at HC Renewal.</li></ul> In summary, there is someone out there who reads Bloomberg and who either 1) supports health IT, but lacks empathy, lacks judgment, and lacks scientific and critical thinking skills or 2) is simply a confabulator and liar. Perversity regarding health IT needs sunlight - lots of it. ----------------------- Here's some of that sunlight in a talk program on "Nurse Talk", a nationally syndicated radio show by and for nurses. <blockquote class="tr_bq"><a href="http://nursetalksite.com/">Nurse Talk</a> is heard on the air in major metropolitan areas on both the West and East Coasts, and worldwide on the Internet, and has partnerships with the largest groups of nurses in the country. </blockquote> Listen to the July 3, 2013 program "RNs DeAnn McEwen and Michelle Mahon on Electronic Medical Records" at <a href="http://nursetalksite.com/2013/07/03/rns-deann-mcewen-and-michelle-mahon/">http://nursetalksite.com/2013/07/03/rns-deann-mcewen-and-michelle-mahon/</a>. -- SS

More Perversity on Health IT Risks, and ... EHR Sense from Nurses on "Nurse Talk", a Syndicated Radio Show

As I mentioned on July 2 at this post, in a June 25, 2013 Bloomberg News article "Digital Health Records’ Risks Emerge as Deaths Blamed on Systems" by technology reporter Jordan Robertson an EHR-harms…

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05 Jul 2013

Is ONC's definition of "Significant EHR Risk" when body bags start to accumulate on the steps of the Capitol?

In a June 25, 2013 Bloomberg News article "<a href="http://www.bloomberg.com/news/2013-06-25/digital-health-records-risks-emerge-as-deaths-blamed-on-systems.html">Digital Health Records’ Risks Emerge as Deaths Blamed on Systems</a>" by technology reporter Jordan Robertson (<a href="http://go.bloomberg.com/tech-blog/author/jrobertson40/">http://go.bloomberg.com/tech-blog/author/jrobertson40/</a>), an EHR-harms case in which I am (unfortunately) intimately involved as substitute plaintiff is mentioned: <blockquote class="tr_bq">When Scot Silverstein’s 84-year-old mother, Betty, starting mixing up her words, he worried she was having a stroke. So he rushed her to Abington Memorial Hospital in Pennsylvania. After she was admitted, Silverstein, who is a doctor, looked at his mother’s electronic health records, which are designed to make medical care safer by providing more information on patients than paper files do. He saw that Sotalol, which controls rapid heartbeats, was correctly listed as one of her medications. Days later, when her heart condition flared up, he re-examined her records and was stunned to see that the drug was no longer listed, he said. His mom later suffered clotting, hemorrhaged and required emergency brain surgery. She died in 2011. Silverstein blames her death on problems with the hospital’s electronic medical records. “I had the indignity of watching them put her in a body bag and put her in a hearse in my driveway,” said Silverstein, who has filed a wrongful-death lawsuit. “If paper records had been in place, unless someone had been using disappearing ink, this would not have happened.”</blockquote> How can I say that?  Because I trained in this hospital and worked as resident Admitting Officer in that very ED pre-computer.  The many personnel in 2010 who were given the meds history by my mother and myself directed it not to paper for others to see, but to /dev/null. Why can I say that?  Because the hospital's Motion for Prior Restraint (censorship) against me was denied outright by the presiding judge just days before the Bloomberg article was published (<a href="http://en.wikipedia.org/wiki/Prior_restraint">http://en.wikipedia.org/wiki/Prior_restraint</a>): <blockquote class="tr_bq">Prior restraint (also referred to as prior censorship or pre-publication censorship) is <a href="http://en.wikipedia.org/wiki/Censorship" title="Censorship">censorship</a> imposed, usually by a government, on expression before the expression actually takes place. An alternative to prior restraint is to allow the expression to take place and to take appropriate action afterward, if the expression is found to violate the law, regulations, or other rules. Prior restraint prevents the censored material from being heard or distributed at all; other measures provide sanctions only after the offending material has been communicated, such as suits for <a class="mw-redirect" href="http://en.wikipedia.org/wiki/Slander" title="Slander">slander</a> or <a class="mw-redirect" href="http://en.wikipedia.org/wiki/Libel" title="Libel">libel</a>. In some countries (e.g., <a href="http://en.wikipedia.org/wiki/Law_of_the_United_States" title="Law of the United States">United States</a>, <a href="http://en.wikipedia.org/wiki/Constitution_of_Argentina" title="Constitution of Argentina">Argentina</a>) prior restraint by the government is forbidden, subject to certain exceptions, by a <a href="http://en.wikipedia.org/wiki/Constitution" title="Constitution">constitution</a>. Prior restraint is often considered a particularly oppressive form of <a href="http://en.wikipedia.org/wiki/Censorship" title="Censorship">censorship</a> in Anglo-American jurisprudence because it prevents the restricted material from being heard or distributed at all. Other forms of restrictions on expression (such as actions for <a class="mw-redirect" href="http://en.wikipedia.org/wiki/Libel" title="Libel">libel</a> or <a class="mw-redirect" href="http://en.wikipedia.org/wiki/Slander_and_libel#Criminal_libel" title="Slander and libel">criminal libel</a>, <a class="mw-redirect" href="http://en.wikipedia.org/wiki/Slander" title="Slander">slander</a>, <a href="http://en.wikipedia.org/wiki/Defamation" title="Defamation">defamation</a>, and <a href="http://en.wikipedia.org/wiki/Contempt_of_court" title="Contempt of court">contempt of court</a>) implement criminal or civil sanctions only after the offending material has been published. While such sanctions might lead to a <a class="mw-redirect" href="http://en.wikipedia.org/wiki/Chilling_effect_%28term%29" title="Chilling effect (term)">chilling effect</a>, legal commentators argue that at least such actions do not directly impoverish the <a href="http://en.wikipedia.org/wiki/Marketplace_of_ideas" title="Marketplace of ideas">marketplace of ideas</a>. Prior restraint, on the other hand, takes an idea or material completely out of the marketplace. Thus it is often considered to be the most extreme form of censorship.</blockquote> The First Amendment lives. (I wonder if it irks the hospital that they cannot perform <a href="http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians/">sham peer review</a> upon me now that the censorship motion is denied.  Sham peer review is a common reaction by hospital executives to "disruptive" physicians, but I have not worked there since 1987 and I no longer practice medicine.) In the Bloomberg story Mr. Robertson wrote: <div style="margin-left: 40px;">... “So far, the evidence we have doesn’t suggest that health information technology is a significant factor in safety events,” said Jodi Daniel (<a href="http://www.healthit.gov/newsroom/jodi-daniel-jd-mph">http://www.healthit.gov/newsroom/jodi-daniel-jd-mph</a>), director of ONC’s office of policy and planning. “That said, we’re very interested in understanding where there may be a correlation and how to mitigate risks that do occur.”</div> In my opinion this statement represents gross negligence by a government official.  Ms. Daniel is unarguably working for a government agency pushing this technology.   She makes the claim that "so far the evidence we have doesn't suggest significant risk" while surely being aware (or having the fiduciary responsibility to be aware) of the impediments to having such evidence. From my March 2012 post "Doctors and EHRs: Reframing the 'Modernists v. Luddites' Canard to The Accurate 'Ardent Technophiles vs. Pragmatists' Reality" at <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html">http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html </a> (yes, this was more than a year ago): <blockquote class="tr_bq">... The Institute of Medicine of the National Academies noted this in their <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">late 2011 study on EHR safety</a>: <blockquote>... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk. Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety.[IOM (Institute of Medicine). 2012. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">Health IT and Patient Safety: Building Safer Systems for Better Care</a> (PDF). Washington, DC: The National Academies Press, pg. S-2.] </blockquote> Also in the IOM report: <blockquote class="tr_bq">… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect. More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.”</blockquote></blockquote> I also noted that the 'impediments to generating evidence' effectively rise to the level of legalized censorship, as observed by Koppel and Kreda regarding gag and hold-harmless clauses in their JAMA article "<a href="http://jama.ama-assn.org/content/301/12/1276.extract">Health Care Information Technology Vendors' Hold Harmless Clause: Implications for Patients and Clinicians</a>", JAMA 2009;301(12):1276-1278. doi: 10.1001/jama.2009.398. FDA had similar findings about impediments to knowledge of health IT risks, see my Aug. 2010 post "Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun?" at <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html</a>. I also note this from amednews.com's coverage of the ECRI Deep Dive Study (<a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html" target="_blank">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>): <div style="margin-left: 40px;">... In spring 2012, a surgeon tried to electronically access a patient’s radiology study in the operating room but the computer would show only a blue screen. The patient’s time under anesthesia was extended while OR staff struggled to get the display to function properly. That is just one example of 171 health information technology-related problems reported [voluntarily] during a nine-week period [from 36 hospitals] to the ECRI Institute PSO, a patient safety organization in Plymouth Meeting, Pa., that works with health systems and hospital associations in Kentucky, Michigan, Ohio, Tennessee and elsewhere to analyze and prevent adverse events. Eight of the incidents reported involved patient harm, and three may have contributed to patient deaths, said the institute’s 48-page report, first made privately available to the PSO’s members and partners in December 2012. The report, shared with American Medical News in February, highlights how the health IT systems meant to make care safer and more efficient can sometimes expose patients to harm.</div> One wonders if Ms. Daniels' definition of "significant" is when body bags start to accumulate on the steps of the Capitol. I also note she is not a clinician but a JD/MPH. I am increasingly of the opinion that non-clinicians need to be removed from positions of health IT leadership at regional and national levels. In large part many just don't seem to have the experience, insights and perhaps ethics necessary to understand the implications of their decisions. At the very least, such people who never made it to medical school or nursing school need to be kept on a very short leash by those who did. -- SS

Is ONC's definition of "Significant EHR Risk" when body bags start to accumulate on the steps of the Capitol?

In a June 25, 2013 Bloomberg News article "Digital Health Records’ Risks Emerge as Deaths Blamed on Systems" by technology reporter Jordan Robertson (http://go.bloomberg.com/tech-blog/author/jrobertso…

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02 Jul 2013

AMA says EHRs create 'appalling Catch-22' for docs - And just how many experts does it take to screw in a light bulb, anyway?

(NOTE:  this post, being about minor matters like death and financial mayhem, is particularly and unusually [even for me] biting and lacking in euphemisms and political correctness.  If you are easily offended and want the latter, and/or believe we all need to be 'nice' about banal issues like patient injury and death, fraud, and other minor matters, click here:  <a href="http://www.disney.com/">http://www.disney.com</a> and skip the post below.) You were warned. --------------------------------------- At some point, so-called EHR "experts" and pundits need to stop being accommodated for their having ignored years of warnings, complaints, "anecdotes" -a particularly egregious term that comes from those who don't understand risk management, especially academics of the echo chamber-egghead subspecies (<a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">link</a>) - and other signs that health IT is not a beneficent, omniscient gift from the <a href="http://en.wikipedia.org/wiki/Lords_of_Kobol">Lords of Kobol.</a> (The latter is a pun on the business-IT programming language Cobol, of course.) Instead, they simply need to be ridiculed for being stupid. I will do so:  folks, you have been, and remain, stupid: <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/AVvXsEhZE95zecrMVRB1bq9q2g01AUsab2c67jIhlE-ARIcXChO_6KSU5IP-c2sQpFyO-MiKOXWOOrpyAZAeWR-1L3VIpsiYWG_2dldo8bUN1af4BuG8p24xo2u2V_pTviw9_w3ZMLvXbAvwG9Zo/s1600/cow3.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="150" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhZE95zecrMVRB1bq9q2g01AUsab2c67jIhlE-ARIcXChO_6KSU5IP-c2sQpFyO-MiKOXWOOrpyAZAeWR-1L3VIpsiYWG_2dldo8bUN1af4BuG8p24xo2u2V_pTviw9_w3ZMLvXbAvwG9Zo/s200/cow3.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">The Bovine Stare of Incomprehension (click to enlarge)</td></tr></tbody></table> The Bovine Stare of Incomprehension describes the reactions I've gotten over the years to many warnings about health IT.  It was like talking to a cow. So now there's this: <blockquote class="tr_bq"><a href="http://www.govhealthit.com/news/ama-says-ehrs-create-appalling-catch-22-docs">AMA says EHRs create 'appalling Catch-22' for docs</a> May 03, 2013 | Tom Sullivan, Editor As the healthcare industry moves to EHRs, the medical record has essentially been reduced to a tool for billing, compliance, and litigation that also has a sustained negative impact on doctors' productivity, according to Steven J. Stack, MD, chair of the American Medical Association’s board of trustees. </blockquote> Gee, they're only realizing and complaining about that - now?  In 2013? <blockquote class="tr_bq">“Documenting a full clinical encounter in an EHR is pure torment,” Stack said during the CMS Listening Session: Billing and Coding with Electronic Health Records on Friday. </blockquote> (What, the "pure torment" in such a mission-critical function only started with the most recent patches installed last month on the nation's EHRs?  EHRs were just dandy until then?) It's nice to know in May 2013 that “documenting a full clinical encounter [essential to avoid injurious and even lethal mistakes, I anecdotally note - ed.] in an EHR is "pure torment”, several years into an accelerated "National Program for HIT in the HHS" costing hundreds of billions of dollars. I guess sites like this blog, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">this site</a> extant since 1998, and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">other materials</a> written over the years by backwards stubborn health IT iconoclast fear-mongering Luddites were beyond the comprehension level of - those now proffering the exact same pronouncements. <blockquote class="tr_bq">EHRs are also driving the industry toward charts that look remarkably similar because they’re based on templates created by the technology vendors — that includes often using the same words. And that threatens to make doctors appear to be committing fraud by the practice of record cloning, or cutting and pasting from one record to another, when they are not, in fact, acting fraudulently. </blockquote> I guess putting patients in mortal danger from note cloning (and to those too stupid to understand why that is, get off your rear end and look it up, I'm not going to spoon-feed you) is a step better than acting fraudulently... <blockquote class="tr_bq">Alongside the federal mandate to implement an EHR under threat of a monetary fine, that creates what Stack called “an appalling Catch-22 for physicians.” Put another way: The government mandates that doctors use an EHR, the EHR vendors’ templates can sometimes create an appearance of fraud and that, in turn, opens the door for payers to decline reimbursement or, even worse, the government to prosecute doctors for the crime.</blockquote> I guess actual fraud is just anecdotal. <blockquote class="tr_bq">As dire as that sounds, it's an exception that belies the unproven perception that EHRs perpetuate fraud. “Upcoding does not necessarily equate to fraud and abuse,” said Sue Bowman, AHIMA’s senior director of coding and compliance at the same event. “This is an area where more study is needed. We really need to know the causes. Further research is needed on the fraud risk of using EHRs.”</blockquote> Sure, let's study while rolling this stuff out as frantically as we can.  We'll fix it later -- and Jesus, I guess, will heal and reanimate any patients actually harmed by the technology (<a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">link</a> to ECRI Institute Deep Dive Study: 36 hospitals!  Nine weeks!  171 health information technology-related problems voluntarily reported!  Eight injuries!  Three possible deaths!  All mere "anecdotes", of course). <blockquote class="tr_bq">Indeed, Jacob Reider, MD, CMO of ONC, explained that the government and industry do not have good data right now proving whether or not EHRs trigger fraud and abuse.</blockquote> Per the IOM, the same industry does not have good data on harms levels.  (The previous link to a recent small ECRI "Deep Dive" study's probably the most robust we've got on that score, and the figures are not encouraging). So - let's review - <ul><li>poor data on harms, </li><li>poor data on benefits, </li><li>poor data on fraud and abuse.</li></ul>  The logical, ethical course of action thus is: <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/AVvXsEgzFC_WsPusjorZPhSFY5JNJs4lrt-V5x8PZiENWJVqP7gPQUwxbtq0bhjwtsjUvHuXdwrMUrEOAhghWrHjEV5pRduQIHRcyj9uMkKL4OC1x87NkSBUQTkZ2MFlroX8uK0YIz8pxcKCC1jP/s1600/homer-simpson.gif" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgzFC_WsPusjorZPhSFY5JNJs4lrt-V5x8PZiENWJVqP7gPQUwxbtq0bhjwtsjUvHuXdwrMUrEOAhghWrHjEV5pRduQIHRcyj9uMkKL4OC1x87NkSBUQTkZ2MFlroX8uK0YIz8pxcKCC1jP/s200/homer-simpson.gif" width="165" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">D'OH!  LET'S ROLL THE TECHNOLOGY OUT AS FAST AS WE CAN, AND PENALIZE NON-ADOPTERS BESIDES!</td></tr></tbody></table> See how simple logic, ethics and clear thinking can be? <blockquote class="tr_bq">“There is concern that some doctors are using the EHR to obtain payments to which they are not entitled,” said Mickey McGlynn of Siemens Medical Solutions and HIMSS EHR Association. “Any fraud is an important issue and we, as the vendor community, take that very seriously.”</blockquote> Only after independent whistleblower investigations by <a href="http://www.publicintegrity.org/health/medicare/cracking-codes">Fred Schulte of the Center for Public Integrity ("Cracking the Codes")</a>, and by <a href="http://www.nytimes.com/2012/09/22/business/medicare-billing-rises-at-hospitals-with-electronic-records.html?_r=0">New York Times reporters Reed Abelson and Julie Creswell</a>, that is... <blockquote class="tr_bq"> AMA’s Stack offered a triptych of suggestions to CMS and ONC: address EHR usability concerns, provide guidance on EHR use for coding and billing, and make meaningful use stage 2 more flexible for providers. “My purpose is not to denigrate EHRs,” Stack said, explaining that he believes CMS and ONC are genuinely trying to better the current situation.</blockquote> Nice to have <a href="http://en.wikipedia.org/wiki/Caspar_Milquetoast">Caspar Milquetoast </a> on the side of EHR criticism. Knock knock, anyone home, McFly? <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/AVvXsEhtRtjpOxhXTclN2k84gzTCHH0QfGVK4EArboCbP3IGByDNyfeuK8KnsHHBwxufCjhZMfBaX_fi2c3IJcMZ0Ld8LH_e9O9fNum3CO4Vrr-U1ZhuGyPRyBVFK3qZ_kYUNFkVGqyPAHOgcBZO/s1600/hello-mcfly1.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="177" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhtRtjpOxhXTclN2k84gzTCHH0QfGVK4EArboCbP3IGByDNyfeuK8KnsHHBwxufCjhZMfBaX_fi2c3IJcMZ0Ld8LH_e9O9fNum3CO4Vrr-U1ZhuGyPRyBVFK3qZ_kYUNFkVGqyPAHOgcBZO/s320/hello-mcfly1.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Knock knock, anyone home, McFly?</td></tr></tbody></table> Today's EHR systems, for the aforementioned reasons above and more, deserve denigration for patients' sake. <blockquote class="tr_bq"> There are efforts underway, within the government and industry, to more comprehensively understand the unintended consequences of EHR implementation.</blockquote> But let's keep rollin' em out, anyway.  Wheeee!  What fun! Class action attorneys, are you listening? -- SS

AMA says EHRs create 'appalling Catch-22' for docs - And just how many experts does it take to screw in a light bulb, anyway?

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05 May 2013

Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI "Deep Dive" Study of Health IT "Events"

FDA's <a href="http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/default.htm" target="_blank">Center for Devices and Radiological Health</a> director Jeffrey Shuren MD JD voiced the opinion a few years ago that what FDA knows about health IT risks is the "tip of the iceberg" due to systematic impediments to knowledge gathering and diffusion.   See links to source <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html" target="_blank">here</a> and to the FDA Internal Memo on HIT risk - labeled "internal document not intended for public use" and unearthed by investigative reporter <a href="http://www.publicintegrity.org/authors/fred-schulte" target="_blank">Fred Schulte</a> several years ago - <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf" target="_blank">here</a> (PDF). At my Feb. 9, 2013 post "<a href="http://hcrenewal.blogspot.com/2013/02/ecri-institute-pso-uncovers-health.html" target="_blank">A New ECRI Institute Study On Health Information Technology-Related Events</a>" I opined that a new ECRI study was beginning to peer beneath the waterline of Jeff Shuren's iceberg tip, at what may reside underneath that waterline.  Iceberg tips, needless to say, are usually tiny compared to the iceberg's overall size. Reporter Kevin O'Reilly at AMNews (<a href="http://amednews.com/" target="_blank">amednews.com)</a> has now written about that ECRI report. The results of the report are concerning: <blockquote class="tr_bq"> <a href="http://www.ama-assn.org/amednews/2013/02/25/prsa0225.htm" target="_blank">Ways EHRs can lead to unintended safety problems</a> Wrong records and failures in data transfer impede physicians and harm patients, according to an analysis of health technology incidents. By Kevin B. O'Reilly, amednews staff, posted Feb. 25, 2013. In spring 2012, a surgeon tried to electronically access a patient’s radiology study in the operating room but the computer would show only a blue screen. The patient’s time under anesthesia was extended while OR staff struggled to get the display to function properly. That is just one example of 171 health information technology-related problems reported during a nine-week period to the ECRI Institute PSO, a patient safety organization in Plymouth Meeting, Pa., that works with health systems and hospital associations in Kentucky, Michigan, Ohio, Tennessee and elsewhere to analyze and prevent adverse events. Eight of the incidents reported involved patient harm, and three may have contributed to patient deaths, said the institute’s 48-page report, first made privately available to the PSO’s members and partners in December 2012. The report, shared with American Medical News in February, highlights how the health IT systems meant to make care safer and more efficient can sometimes expose patients to harm.</blockquote>  Mar. 1, 2013 addendum.  From ECRI, the denominator is this: <blockquote class="tr_bq"><div class="MsoNormal">Participating facilities submitted health IT related events during the nine-week period starting April 16, 2012, and ending June 19, 2012. ECRI Institute PSO pulled additional health IT events that were submitted by facilities during the same nine-week period as part of their routine process of submitting event reports to ECRI Institute PSO’s reporting program. The PSO Deep Dive analysis consisted of 171 health IT-related events submitted by 36 healthcare facilities, primarily hospitals.   [I note that's 36 of 5,724 hospital in the U.S. per data from the American Hospital Association (<a href="http://www.aha.org/research/rc/stat-studies/fast-facts.shtml" target="_blank">link</a>), or appx. 0.6 %.  A very crude correction factor in extrapolation would be about x 159 on the hospital count issue alone, not including the effects of the voluntary nature of the study, of non-hospital EHR users, etc.  Extrapolating from 9 week to a year, the figure becomes about x 1000.  Accounting for the voluntary nature of the reporting (5% of cases per Koppel), the corrective figure approaches x20,000.  Extrapolation of course would be less crude if # total beds, degree of participant EHR implementation/use, and numerous other factors were known, but the present reported numbers are a cause for concern - ed.] </div></blockquote> Sept. 2013 addendum:  Health Leaders Media has more on the ECRI Deep Dive study at <a href="http://www.healthleadersmedia.com/print/TEC-290834/HIT-Errors-Tip-of-the-Iceberg-Says-ECRI">http://www.healthleadersmedia.com/print/TEC-290834/HIT-Errors-Tip-of-the-Iceberg-Says-ECRI</a>: <blockquote class="tr_bq">HIT Errors 'Tip of the Iceberg,' Says ECRI Cheryl Clark, for HealthLeaders Media , April 5, 2013 Healthcare systems' transitions from paper records to electronic ones are causing harm and in so many serious ways, providers are only now beginning to understand the scope. Computer programs truncated dosage fields, leading to morphine-caused respiratory arrest; lab test and transplant surgery records didn't talk to each other, leading to organ rejection and patient death; and an electronic systems' misinterpretation of the time "midnight" meant an infant received antibiotics one dangerous day too late. These are among the 171 health information technology malfunctions and disconnects that caused or could have caused patient harm in a report to the <a href="https://www.ecri.org/Pages/default.aspx" target="_blank">ECRI</a> Institute's Patient Safety Organization. ... The 36 hospitals that participated in the ECRI IT project are among the hospitals around the country for which ECRI serves as a Patient Safety Organization, or PSO. The 171 events documented, break down like this: <ul><li>53% involved a medication management system. <ul><li>25% involved a computerized order entry system</li><li>15% involved an electronic medication administration record</li><li>11% involved pharmacy systems</li><li>2% involved automated dispensing systems</li></ul></li><li>17% were caused by clinical documentation systems</li><li>13% were caused by Lab information systems</li><li>9% were caused by computers not functioning</li><li>8%. Were caused by radiology or diagnostic imaging systems, including PACS</li><li>1% were caused by clinical decision support systems</li></ul> Karen Zimmer, MD, medical director of the institute, says the reports of so many types of errors and harm got the staff's attention in part because the program captured so many serious errors within just a nine-week project last spring.  The volume of errors in the voluntary reports was she says, "an awareness raiser." "If we're seeing this much under a voluntary reporting program, we know this is just the tip of the iceberg; we know these events are very much underreported."</blockquote> As at the opening of this post, "tip of the iceberg" is a phrase also used by FDA CDRH director Jeffrey Shuren MD JD regarding safety issues with EHRs and other health IT. Along those lines, at my April 2010 post "<a href="http://hcrenewal.blogspot.com/2010/04/if-benefits-of-hit-can-be-guesstimated.html" target="_blank">If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers</a>" I proposed a "thought experiment" to theoretically extrapolate limited data on health IT risk to a national audience, taking into account factors that limited transparency and thus reduced known injury and fatality counts. The results were undesirable, to say the least - but it was a thought experiment only. Using the current data, coming from a limited, voluntary set of information over 9 weeks, I opine that the results of an extrapolation to a national (or worldwide) level, in an environment of rapidly increasing adopters (many of whom are new to the technology), on an annual basis, not a mere 9 weeks - would not look pretty. <blockquote class="tr_bq">The institute’s report did not rate whether electronic systems were any less safe than the paper records they replaced. The report is intended to alert hospitals and health systems to the unintended consequences of electronic health records. </blockquote> Ethically, this is really not relevant towards national rollout, especially with penalties beginning to accrue to non-adopters of HHS "Certified" technology in a few years. As I've written on this blog, medical ethics generally do not condone experimentation without informed consent, especially when the experimental devices are of unknown risk. Not knowing the risks of IT, it really doesn't matter, ethically, what the safety of paper is.  "Hope" is not a valid reason for medical experimentation.  (See below for what a PubMed search reveals about risks of paper records.) The unspoken truth prevalent in healthcare today seems to be this:  the sacrifice of individual patients to a technology of unknown risk is OK, as long as - we hope -  it advances the greater good.    Perhaps that should be explicitly admitted by the HIT industry's <a href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-disregard-for.html" target="_blank">hyper-enthusiast proponents</a> who ignore the downsides, so the spin can be dropped and there can be clarity? <blockquote class="tr_bq">The leading cause of problems was general malfunctions [also known by the benign-sounding euphemism "<a href="http://hcrenewal.blogspot.com/search/label/glitch" target="_blank">glitches</a>" - ed.]  responsible for 29% of incidents. For example, following a consultation about a patient’s wounds, a nurse at one hospital tried to enter instructions in the electronic record, but the system would not allow the nurse to type more than five characters in the comment field. Other times, medication label scanning functions failed, or an error message was incorrectly displayed every time a particular drug was ordered. One system failed to issue an alert when a pregnancy test was ordered for a male patient. [These 'general malfunctions' are thus not just computer bugs undetected due to inadequate pre-rollout testing, but also examples of design flaws due to designer-programmer-seller-buyer-implementer lack of due diligence, i.e.,  negligence - ed.] A quarter of incidents were related to data output problems, such as retrieving the wrong patient record because the system does not ask the user to validate the patient identity before proceeding. This kind of problem led to incorrect medication orders and in one case an unnecessary chest x-ray. Twenty-four percent of incidents were linked to data-input mistakes. For example, one nurse recorded blood glucose results for the wrong patient due to typing the incorrect patient identification number to access the record.  [Many of these are likely due to what NIST has termed "<a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html" target="_blank">use error</a>" - user interface designs that will engender users to make errors of commission or omission - as opposed to "user error" i.e., carelessness - ed.] Most of remaining event reports were related to data-transfer failures, such as a case where a physician’s order to stop anticoagulant medication did not properly transfer to the pharmacy system. The patient received eight extra doses of the medication before it was stopped. [Due to outright software, hardware and/or network problems and defects - ed.]</blockquote> I've been writing about such issues since 1998, not because I imagined them.  As a CMIO I saw them firsthand; as teacher and mentor I heard about them from colleagues; as a writer I heard about them via (usually unsolicited) emails from concerned clinicians; as an independent expert witness on health IT harms I've heard about them from Plaintiff's attorneys, but not from the Defense side of the Bar as yet.  Of course the reasons for that are understandable -  albeit disappointing. In fact, robust studies of a serious issue - the actual risks of paper towards harm causation - and further, whether any of the issues are remediable without spending hundreds of billions of dollars on IT - seem scarce.  I've asked the PA Patient Safety Authority about the possibility of using data in the Pennsylvania Patient Safety Reporting System (PA-PSRS) database, just as they did for EHR-related medical events, to determine incidence of paper-related medical events.  They are pondering the issue. As an aside, I note that it would be ironic if the relative risks of both IT and paper were not really robustly known.  (I note that in a PubMed search on "<a href="http://www.ncbi.nlm.nih.gov/pubmed/?term=risks+of+paper+medical+records" target="_blank">risks of paper medical records</a>", not much jumps out.)  IT hyper-enthusiasts will not even debate the issue of studying whether a good paper system might be safer for patients in some clinical environments than bad health IT. Considering the tremendous cost and unknown risk of today's health IT (and perhaps the unknown risk of paper, too), would it not make more sense, and be consistent with the medical Oath, to leave paper in place where it is currently used - and perhaps improve its performance - until we "get the IT right" in controlled, sequestered environments, prior to national rollout? In other words, as I've asked before on these pages, should we not slow down the IT push and adhere to traditional (and hard-learned) cautions on medical research? Even asking such questions brings forth logical fallacies such as straw arguments (e.g., UCSF's <a href="http://community.the-hospitalist.org/" target="_blank">Bob Wachter</a> in a recent discussion I initiated with several investigative reporters: "...where we part ways is your defense of paper and pencil. I understand advocacy, and you have every right to bang this particular drum"), ad hominem attacks, etc. <blockquote class="tr_bq">... It is not enough for physicians and other health care leaders to shop carefully for IT systems, the report said. Ensuring that systems such as computerized physician order entry and electronic health records work safely has to be a continuing concern, said Karen P. Zimmer, MD, MPH, medical director of the ECRI Institute PSO. “Minimizing the unintended consequences of health IT systems and maximizing the potential of health IT to improve patient safety should be an ongoing focus of every health care organization,” she said.</blockquote> I recommended that clinicians take matters into their own hands if their leaders do not, as at the bottom of my post <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">here</a>.  This advice bears repeating: <blockquote class="tr_bq">... When a physician or other clinician observes health IT problems, defects, malfunctions, <a href="http://www.tinyurl.com/hostileuserexper">mission hostility</a> (e.g., poor user interfaces), significant downtimes, lost data, erroneous data, misidentified data, and so forth ... and most certainly, patient 'close calls' or actual injuries ... they should (anonymously if necessary if in a hostile management setting): (DISCLAIMER:  I am not responsible for any adverse outcomes if any organizational policies or existing laws are broken in doing any of the following.) <ul><li>Inform their facility's senior management, if deemed safe and not likely to result in retaliation such as being slandered as a "<a href="http://www.jpands.org/vol9no3/huntoon.pdf">disruptive physician</a>" and/or or being subjected to sham peer review (<a href="http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians/">link</a>).</li></ul><ul><li>Inform their personal and organizational insurance carriers, in writing. Insurance carriers do not enjoy paying out for preventable IT-related medical mistakes. They have begun to become aware of HIT risks. See, for example, the essay on Norcal Mutual Insurance Company's newsletter on HIT risks<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=norcal"> at this link</a>. (Note - many medical malpractice insurance policies can be interpreted as requiring this reporting, observed occasional guest blogger <a href="http://hcrenewal.blogspot.com/search/label/Dr.%20Scott%20Monteith">Dr. Scott Monteith</a> in a comment to me about this post.)</li></ul><ul><li>Inform the Joint Commission (or similar national accreditor of hospital safety if not in the U.S.) via their complaint site at <a href="http://www.jointcommission.org/report_a_complaint.aspx">http://www.jointcommission.org/report_a_complaint.aspx</a> . Also consider writing the JC senior officers (<a href="http://www.jointcommission.org/about_us/joint_commission_officers.aspx">link to officer's list</a>), whose awareness of HIT issues I can personally attest to via our correspondences.</li></ul><ul><li>Inform the FDA (or similar healthcare regulator if not in the U.S.) via the FDA Medwatch Form 3500 reporting site at <a href="https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm">https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm</a>. An example of such an adverse event report I filed myself (when the involved hospital refused) is <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=1729552">at this link</a> in the FDA MAUDE (Manufacturer and User Facility Device Experience) database.</li></ul><ul><li>Inform the State Medical Society and local Medical Society of your locale.</li></ul><ul><li>Inform the appropriate Board of Health for your locale.</li></ul><ul><li>If applicable (and it often is), inform the Medicare Quality Improvement Organization (QIO) of your state or region. Example: in Pennsylvania, the QIO is "<a href="http://www.qipa.org/Home.aspx">Quality Insights of PA</a>."</li></ul><ul><li>Inform a personal attorney.</li></ul><ul><li>Inform local, state and national representatives such as congressional representatives. Sen. Grassley of Iowa is aware of these issues, for example.</li></ul><ul><li>As clinicians are often forced to use health IT, at their own risk even when "certified" (<a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html">link</a>), if a healthcare organization or HIT seller is sluggish or resistant in taking corrective actions, consider taking another risk (perhaps this is for the very daring or those near the end of their clinical career). Present your organization's management with a statement for them to sign to the effect of:</li></ul><blockquote>"We, the undersigned, do hereby acknowledge the concerns of [Dr. Jones] about care quality issues at [Mount St. Elsewhere Hospital] regarding EHR difficulties that were reported, namely [event A, event B, event C ... etc.] We hereby indemnify [Dr. Jones] for malpractice liability regarding patient care errors that occur due to EHR issues beyond his/her control, but within the control of hospital management, including but not limited to: [system downtimes, lost orders, missing or erroneous data, etc.] that are known to pose risk to patients. We assume responsibility for any such malpractice. With regard to health IT and its potential negative effects on care, Dr. Jones has provided us with the Joint Commission Sentinel Events Alert on Health IT at <a href="http://www.jointcommission.org/assets/1/18/SEA_42.PDF" style="font-style: italic;">http://www.jointcommission.org/assets/1/18/SEA_42.PDF</a>, the IOM report on HIT safety at <a href="http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF" style="font-style: italic;">http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF</a>, and the FDA Internal Memorandum on H-IT Safety Issues at <a href="http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology" style="font-style: italic;">http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology</a>. CMO __________ (date, time) CIO ___________ (date, time) CMIO _________ (date, time) General Counsel ___________ (date, time) etc."</blockquote><ul><li>If the hospital or organizational management refuses to sign such a waiver (and they likely will!), note the refusal, with date and time of refusal, and file away with your attorney. It could come in handy if EHR-related med mal does occur.</li></ul><ul><li>As EHRs remain experimental, I note that indemnifications such as the above probably belong in medical staff contracts and bylaws when EHR use is coerced.</li></ul></blockquote> These recommendations still stand, although after this recent story, my caution about retaliation should be re-emphasized: <blockquote class="tr_bq">The Advisory Board Company Feb. 14, 2013 <a href="http://www.advisory.com/Daily-Briefing/2013/02/15/Jury-Hospital-CEO-framed-physician-by-planting-gun" target="_blank">Hospital Framed Physician; Planted a Gun </a></blockquote> -- SS

Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI "Deep Dive" Study of Health IT "Events"

FDA's Center for Devices and Radiological Health director Jeffrey Shuren MD JD voiced the opinion a few years ago that what FDA knows about health IT risks is the "tip of the iceberg" due to systemati…

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28 Feb 2013

Guest post by Dr. Jon Patrick, U. of Sydney: On the ECRI Institute's recommendations following a "deep-dive" study of HIT-related events

At my Feb. 9, 2013 post "<a href="http://hcrenewal.blogspot.com/2013/02/ecri-institute-pso-uncovers-health.html" target="_blank">ECRI Institute PSO Uncovers Health Information Technology-Related Events in Deep Dive Analysis</a>", I wrote about an ECRI Institute study of well-defined client data submitted over a 9-week period (a "deep dive" study) on EHR problems.  Risk-creating events at a level that should be a significant concern to patients and clinicians fell into the following categories:  <ul><li>inadequate data transfer from one HIT system to another </li><li>data entry in the wrong patient record</li><li>incorrect data entry in the patient record</li><li>failure of the HIT system to function as intended </li><li>configuration of the system in a way that can lead to mistakes </li></ul> Dr. Jon Patrick at U. Sydney, a scientist and medical informatician who sees the issues from a number of unique perspectives (<a href="http://rp-www.cs.usyd.edu.au/~jonpat/CV/CV_brief.html" target="_blank">link to bio</a>), has offered the following critique of the key recommendations made by the ECRI Institute as a result of this study of health IT events (see aforementioned post for the text of those recommendations).  One caveat is that neither he nor I have the full report as of this writing in part due to expense: <blockquote class="tr_bq">The ECRI has produced a report on HIT errors. I was concerned about the manner in which the Key Recommendations minimised, generalised or failed to concretise important issues that I offer these comments. On ECRI Key Recommendations: 1. Enlist leaders’ commitment and support for the organization’s health IT projects. JP: This is clearly a comment from one level of  management to those levels above it. It doesn't seem to be a comment about the nature of the HIT itself but more about the internal processes to getting it established. There is really not much to say here because if upper management don't want to do anything about the introduction of HIT then engaging in the task is probably futile, hence it was difficult to understand why it was included. 2. Involve health IT users in system planning, design, and selection. JP: yes, this is crucial to successful solutions. 3. Conduct a review of workflow and processes to determine how they must be modified. JP: the missing clause at the end of this sentence is "to fit the introduced HIT system". This is putting the cart before the horse. The notion that a piece of software designed by engineers should have priority over the team of clinicians who are experts in their business is highly naive. Also this statement is in contradiction to point 2 above. The privileging of the functioning of  the IT system as the expert over that of the clinical team, AND making a recommendation in contradiction to an earlier recommendation is absurd enough by itself  to undermine the credibility of  the report. 4. Evaluate the ability of existing IT systems within the organization to reliably exchange data with any health IT system under consideration. JP: And after the evaluation what should be done. This is hardly an informative recommendation. It is of the form "Do Something, it doesn't matter what you do, just do something."  A more compelling statement that would have enhanced the credibility of the authors and demonstrate their knowledge of the industry would have been: " Establish unambiguously and conclusively that any health IT system under consideration has the ability to reliably exchange data with existing IT systems within the organization". Note the focus needs to be on the incoming system being the object of conformity not the incumbent systems. 5. Conduct extensive tests before full implementation to ensure that the health IT system operates as expected. JP: this is a clearly a desirable goal and applies to point 4 above as well as all other aspects of the system functions. 6. Provide user training and ongoing support; educate users about the capabilities and limitations of the system. JP: This is a motherhood statement that does nothing to contribute to the nub of training issues in the use of HIT. Training is an ongoing issue for two reasons: staff change and new staff come on to the roster and need to be trained, and, these systems are complex and expert advice and skill needs to be available to staff as an ongoing service so that work is not delayed due to confusion on how to use the IT. An alternative proposal to reduce training costs and investment would be to design the system so that it matches current best practice of the clinical team so that learning the system is minimised because it fits seamlessly into their work processes. Surely the issue of educating users about the capabilities and limitations of the system is independent of the training topic. The users will discover on their own bat the limitations of the system as they try to use it. 7. Closely monitor the system’s ease of use and promptly address problems encountered by users. JP:This is a quite inadequate description of the action that needs to be taken. The real consideration is for them to have an effective avenue for expressing the limitations in a manner that is acceptable and they are NOT chastised as malcontents [or Luddites or technophobes - ed.] AND that the unnecessary or dangerous limitations are addressed promptly. 8. Introduce alterations to a health IT system in a controlled manner. JP: It is hard to understand what is meant by this statement. Firstly I would have said "introduce alterations to the clinical processes  in a controlled manner". Secondly, alterations to the HIT system need to be done promptly  when it is defective. Once again, as in point 3 above the technology is being preferenced over the clinical processes which I argue is back-to-front. 9. Monitor the system’s effectiveness with metrics established by the organization. JP: This is definitely something that should be done but it also needs a more directed purpose. It is easy to say to assess patient safety but most systems don't readily capture relevant data or supply analytical devises to easily draw a picture of patient  safety. However there is an equally important factor in care that is often overlooked and that is staff productivity and by implication morale. There is a need to understand better ways of assessing staff productivity in positive ways and the effect a CIS has on staff morale.  Typical comments about CISs is that they cost staff  up to 20% more time to maintain the patient record. Staff wouldn't mind giving up that time if it was returned in some other form, but it isn't, so they feel the time is stolen from them or from their patients. 10. Require reporting of health IT- related events and near misses. JP: This is poorly stated and is probably meant to read "health IT - related adverse events". This is a positive recommendation but does not go far enough. A more comprehensive statement would be "Install a process and technology for reporting adverse events and establish methods for evaluating the reports and recommending changes to clinical practice, or technology functionality and implementing them. 11. Conduct thorough event analysis and investigation to identify corrective measures. JP: This  goes some way to dealing with my point in item 10 above. Its weakness is in not identifying the types of problems and taking a firm stance on completing the correct action. SOME of the Items that have been OVERLOOKED 1. The system needs to be alterable at any time by the clinical leadership so as to immediately emplace revised work practices when they are approved. 2. The system needs to have native analytics so that the clinical leadership can monitor the activities of their teams and provide evidenced based feedback to support continuous process improvement. 3. The system needs highly accurate natural language processing so that the search for required content though the clinical record can be fast, efficient and reliable. Professor Jon Patrick Chair of Language Technology School of Information Technologies Faculty of Engineering University of Sydney Health Information Technologies Research Laboratory <a href="http://www.it.usyd.edu.au/~hitru">http://www.it.usyd.edu.au/~hitru</a></blockquote> This is excellent advice coming from perhaps the only computing expert in the world who's conducted a forensic analysis of a major commercial EHR product, one intended for high-risk ED's.  His analysis of that product, intended for government-mandated rollout in public hospitals in Dr. Patrick's Australian state of New South Wales, is at this link. This work has largely been ignored by the health IT industry and the academic Medical Informatics community.  However, I can assure the industry and the academic community that the report will not be ignored by those in the legal community if (perhaps I should say when) patients are injured or killed by the system's deficiencies. -- SS

Guest post by Dr. Jon Patrick, U. of Sydney: On the ECRI Institute's recommendations following a "deep-dive" study of HIT-related events

At my Feb. 9, 2013 post "ECRI Institute PSO Uncovers Health Information Technology-Related Events in Deep Dive Analysis", I wrote about an ECRI Institute study of well-defined client data submitted ov…

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13 Feb 2013

A New ECRI Institute Study On Health Information Technology-Related Events

As I wrote <a href="http://hcrenewal.blogspot.com/2012/12/pennsylvania-patient-safety-authority.html" target="_blank">here</a>, I was a reviewer of the report in the PA-based, ECRI Institute-conducted study "The Role of the Electronic Health Record in Patient Safety Events."  ECRI studied the Pennsylvania Patient Safety Reporting System database for HIT-related errors.    <blockquote class="tr_bq">The <a href="http://www.ecri.org/" target="_blank">ECRI Institute</a> is an independent organization renowned for its safety testing of medical technologies and reporting on same, and that "researches the best approaches to improving the safety, quality, and cost-effectiveness of patient care."  I've mentioned it and its bylaws in this blog in the past as a model for independent, unbiased testing and reporting of healthcare technologies. </blockquote> The full report in PDF is <a href="http://www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2012/Dec;9%284%29/documents/113.pdf" target="_blank">at this link</a>.  In the report, the Pennsylvania Patient Safety Authority analyzed reports of EHR-related events from a state database (the Pennsylvania Patient Safety Reporting System or PA-PSRS, pronounced "PAY-sirs") of reported medical errors and identified several major themes. My review input led to a discrete "limitations" section.  Also, my invited July 2012 presentation to the PA Patient Safety Authority "Asking the Right Questions: Using Known HIT Safety Issues to Improve Risk Reporting and Analysis" with ECRI in attendance (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/PA_patient_safety_Jul2012.ppt" target="_blank">link to PPT here</a>) on the danger of limited datasets due to systematic impediments to information diffusion was apparently taken seriously.  ECRI decided to do something about the knowledge gap, and they asked the right questions. They've just released this summary of a new study they conducted.  I have a few comments which follow:    <blockquote class="tr_bq"><a href="http://www.prnewswire.com/news-releases/ecri-institute-pso-uncovers-health-information-technology-related-events-in-deep-dive-analysis-190064661.html" target="_blank">ECRI Institute PSO Uncovers Health Information Technology-Related Events in Deep Dive Analysis</a> Data transfer, data entry, system configurations, and more identified as serious problem areas   PLYMOUTH MEETING, Pa., Feb. 6, 2013 /PRNewswire-USNewswire/ -- The federal government is spending about $19 billion to encourage hospitals, physician practices, and other healthcare organizations to invest in their health information technology (HIT) infrastructure with the goal of improving patient safety and quality through the Health Information Technology for Economic and Clinical Health (HITECH) Act. Concerned about the unintended consequences of HIT and the potential for errors to cause patient harm, <a href="https://www.ecri.org/PatientSafetyOrganization/Pages/default.aspx" target="_blank">ECRI Institute Patient Safety Organization</a> (PSO) recently conducted a PSO Deep Dive™ analysis on HIT-related safety events. Their just-released 48-page report identified five potential problem areas, which can be assessed with the accompanying toolkit. The <a href="https://eshop.ecri.org/p-140-pso-deep-dive-health-information-technology.aspx" target="_blank">report and toolkit are available for purchase</a> [appx. $350 U.S. - ed.] without membership in ECRI Institute PSO. "Minimizing the unintended consequences of HIT systems and maximizing the potential of HIT to improve patient safety should be an ongoing focus of every healthcare organization," says Karen P. Zimmer , MD, MPH, FAAP, medical director, ECRI Institute PSO. Based on [voluntary - ed.] reports submitted to the PSO from participating organizations, ECRI Institute PSO experts identified the following key HIT-related problems: <ul type="disc"><li>inadequate data transfer from one HIT system to another </li><li>data entry in the wrong patient record </li><li>incorrect data entry in the patient record </li><li>failure of the HIT system to function as intended </li><li>configuration of the system in a way that can lead to mistakes </li></ul> To collect enough reports for meaningful evaluation, ECRI Institute PSO asked participating organizations to submit standardized data about HIT events during a nine-week period. This enabled ECRI Institute PSO to identify patterns and trends from the aggregated data and share the findings, as well as its recommendations. The data in the PSO Deep Dive represents only that collected using the Agency for Healthcare Research and Quality (AHRQ) HIT Common Formats.  [Not the improved formats developed by AHRQ in their <a href="http://healthit.ahrq.gov/HealthITHazardManagerFinalReport" target="_blank">IT Hazards Manager project</a>, still in development - ed.]  ECRI Institute PSO data encompasses over 800 HIT-related events. According to the report, HIT must be considered in the context of the environment in which it operates during the three phases of any HIT project: planning for new or replacement systems, system implementation, and ongoing use and evaluation of the system. "Shortsighted approaches to HIT can lead to adverse consequences," caution the authors. "Healthcare organizations should consider the findings and recommendations in the PSO Deep Dive as part of their effort to achieve those goals," adds Zimmer. The HIT PSO Deep Dive findings were published in a 48-page report and toolkit with self-assessment questionnaire and action plan form available to all ECRI Institute PSO Members and its partner PSO members. The table of contents of the report is available for <a href="https://www.ecri.org/EmailResources/PSRQ/ECRI_Institute_PSO_Deep%20Dive_HIT_TOC.pdf" target="_blank">free viewing/download</a>. Additional information will be presented in ECRI Institute PSO's Monthly Brief free e-newsletter March edition; go to <a href="https://www.ecri.org/psobrief" target="_blank">www.ecri.org/psobrief</a> to sign up. The full report and toolkit are also <a href="https://eshop.ecri.org/p-140-pso-deep-dive-health-information-technology.aspx" target="_blank">available for purchase</a>. For questions about this topic, or for information about purchasing the report, please contact ECRI Institute PSO by telephone at (610) 825-6000, ext. 5558; by e-mail at <a href="mailto:pso@ecri.org" target="_blank">pso@ecri.org</a>; by fax at <a href="tel:%28610%29%20834-1275" target="_blank" value="+16108341275">(610) 834-1275</a>, or by mail at 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA.</blockquote> From the free linked TOC document: Key Recommendations <ul><li>Enlist leaders’ commitment and support for the organization’s health IT projects.</li></ul><ul><li>Involve health IT users in system planning, design, and selection.</li></ul><ul><li>Conduct a review of workflow and processes to determine how they must be modified.</li></ul><ul><li>Evaluate the ability of existing IT systems within the organization to reliably exchange data with any health IT system under consideration.</li></ul><ul><li>Conduct extensive tests before full implementation to ensure that the health IT system operates as expected.</li></ul><ul><li>Provide user training and ongoing support; educate users about the capabilities and limitations of the system.</li></ul><ul><li>Closely monitor the system’s ease of use and promptly address problems encountered by users.</li></ul><ul><li>Introduce alterations to a health IT system in a controlled manner.</li></ul><ul><li>Monitor the system’s effectiveness with metrics established by the organization.</li></ul><ul><li>Require reporting of health IT-related events and near misses.</li></ul><ul><li>Conduct thorough event analysis and investigation to identify corrective measures.</li></ul> My comments are these: <ul><li>The ECRI study, report and recommendations are quite welcome. </li></ul><ul><li>The case reports received were apparently voluntary and probably "conservative" and understated as hospitals are not happy to release data on problems and harms that can lead to, or support, litigation.   </li></ul><ul><li>The study was just 9 weeks long, and with a limited set of healthcare organizations participating.  800 HIT-related events were identified. </li></ul><ul><li> The relevant issues discovered in the events, as summarized in the bullet points above, are capable of causing clinician distraction, incorrect decisions, "use error" (as opposed to "user error", see <a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html" target="_blank">here</a>), patient harm, and death.  (I am aware of such issues in the press including harms and deaths, as readers here have read at links such as <a href="http://hcrenewal.blogspot.com/search/label/glitch" target="_blank">these</a> and <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html" target="_blank">these</a> and <a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html" target="_blank">these</a> and <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html" target="_blank">these</a>, and others about which I am providing expert-witness consultation and cannot share.) </li></ul><ul><li>I believe ECRI has now begun to peer below the water level, through the muck of industry control of the narrative, of what FDA CDRH leader Jeffrey Shuren MD JD referred to as "<a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html" target="_blank">the tip of the iceberg</a>" - i.e., the current level of knowledge of health IT difficulties, defects and harms. </li></ul><ul><li>The report is yet another red flag for a far more robust (and mandatory, in my view) post-marketing surveillance of health IT.   </li></ul><ul><li>Those who claim these findings are "anecdotes" (as <a href="http://hcrenewal.blogspot.com/2013/02/ama-news-ehr-sloppy-and-paste-and-why.html" target="_blank">here</a>) are looking increasingly foolish and cavalier. </li></ul> Finally, readers of this blog have been reading about these issues for years.  You heard it here first. -- SS

A New ECRI Institute Study On Health Information Technology-Related Events

As I wrote here, I was a reviewer of the report in the PA-based, ECRI Institute-conducted study "The Role of the Electronic Health Record in Patient Safety Events." ECRI studied the Pennsylvania Pati…

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09 Feb 2013

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