healthy4u: Cliff Rieders

ONC and "Health IT Patient Safety Action & Surveillance Plan": When Sociologists Uphold the Hippocratic Oath While Physicians Pay Respect to the Lords of Kobol, We Are in a Dark Place, Ethically

[Note: this essay contains many hyperlinks. They can be right-clicked and opened in a separate tab or window.] I've been meaning to write more on the just-before-Christmas, Friday afternoon, minimal-visibility release of the ONC report I'd written about in my Dec. 23, 2012 post "<a href="http://hcrenewal.blogspot.com/2012/12/oncs-christmas-confessional-on-health.html" target="_blank">ONC's Christmas Confessional on Health IT Safety: HIT Patient Safety Action & Surveillance Plan for Public Comment</a>."   (The ONC report itself is available <a href="http://www.healthit.gov/sites/default/files/safetyplanhhspubliccomment.pdf" target="_blank">at this link</a> in PDF.) The Boston Globe and Globe staff writer Chelsea Conaboy, however, have beaten me to the punch in the Jan. 3, 2013 article "Federal government releases patient safety plan for electronic health records", link below. ('<a href="http://en.wikipedia.org/wiki/Lords_of_Kobol" target="_blank">Lords of Kobol</a>', of course, is a pun.  They were fictional gods in a sci-fi series from the 1970's and a remake a few years ago, but in my circles the term is used satirically and derisively to reflect people expressing inappropriate overconfidence in - and perhaps worship of - computers.   <a href="http://en.wikipedia.org/wiki/COBOL" target="_blank">Cobol</a>, the COmmon Business-Oriented Language, is one of the oldest programming languages and was the major programming language of the merchant computing sector, including business, finance, and administrative systems for companies and governments.) First, I do want to reiterate what I'd mentioned in my earlier post:  the new ONC report is a sign of progress, in terms of a government body explicitly recognizing the social responsibilities incurred by conducting the mass human subjects experiment of national health IT.  However, I also wrote: <blockquote class="tr_bq">... [The ONC report] is still a bit weak in acknowledging the likely magnitude of under-reporting of medical errors, including HIT-related, in the available data, and the issue of risk vs. 'confirmed body counts' as I wrote at my recent post "<a href="http://hcrenewal.blogspot.com/2012/12/a-very-signifcant-additonal-observation.html" target="_blank">A Significant Additional Observation on the PA Patient Safety Authority Report -- Risk</a>". </blockquote> The Globe quoted a number of people involved the health IT debate, and I am now commenting on their Jan. 3 article: <blockquote class="tr_bq"><a href="http://www.boston.com/whitecoatnotes/2013/01/03/federal-government-releases-patient-safety-plan-for-electronic-health-records/KBqYjU4Gsup8vnx6ppgfOP/story.html?comments=all#readerComm" target="_blank">Federal government releases patient safety plan for electronic health records</a> Boston Globe</blockquote><blockquote>01/03/2013 11:16 AM    By Chelsea Conaboy, Globe Staff The federal office in charge of a massive rollout of electronic health records has issued a plan aimed at making those systems safer by encouraging providers to report problems to patient safety organizations. Though some in the field say it doesn’t go far enough, others said the plan is an important step for an office whose primary role has been cheerleader for a technology that has the potential to dramatically improve health care in the United States but that may come with significant risks.</blockquote> A major issue at the heart of the controversy is the fact that, admittedly, nobody knows the magnitude of the risks - in large part due to systematic impediments to knowing.  This has been admitted by organizations including the Joint Commission (<a href="http://hcrenewal.blogspot.com/2008/12/joint-commission-sentinel-events-alert.html" target="_blank">link</a>), U.S. FDA (<a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">link</a>; albeit in an "internal memo" never intended for public view, and discovered only through the hard work of Center for Public Integrity investigative reporter Fred Schulte when he was at the Huffington Post Investigative Fund), Institute of Medicine of the U.S. National Academies (<a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">link</a>, quoted at midsection of post), and others.  I have made the claim that when you don't know the level of harm of an intervention in healthcare, and there are risk management-relevant case reports of dangers, you don't go gung-ho and start a national-scale implementation with penalties for non-adopters, and then decide to study safety, quality, usability etc.  You determine safety first in more controllable and constrained environments.  Anything else is, as I wrote, putting the cart before the horse (<a href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html" target="_blank">link</a>). <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/AVvXsEh7nInx820f0ENnQAtyZPnEg9adrMvhxLkh-27yVmfwbjwdrm-ybDsdcNvioqVXyXGr_jquEVlg5-HtZ-d5lkfacpkRkVIgVfJbGXHB6iEAHGFAMDFmOy8xsmqHRl_de_qjAh1p2VB0fpoC/s1600/horse-cart.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="131" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh7nInx820f0ENnQAtyZPnEg9adrMvhxLkh-27yVmfwbjwdrm-ybDsdcNvioqVXyXGr_jquEVlg5-HtZ-d5lkfacpkRkVIgVfJbGXHB6iEAHGFAMDFmOy8xsmqHRl_de_qjAh1p2VB0fpoC/s200/horse-cart.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Things are a bit out of order here.</td></tr></tbody></table> You also certainly don't dismiss risk management-relevant case reports from credible observers as "anecdotal", the common refrain of hyperenthusiasts and (incompetent) scientists who conflate scientific research with risk management - as a researcher from Down Under eloquently observed in the Aug. 2011 guest post "<a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html" target="_blank">From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things</a>."  Back to the Globe: <blockquote class="tr_bq"> A year ago, the Institute of Medicine issued a report urging the federal government to do more to ensure the safety of electronic health records. It highlighted instances in which the systems were linked to patient injury, deaths, or other unsafe conditions. The report suggested creating an independent body to investigate problems with electronic records and to recommend fixes, similar to how the National Transportation Safety Board investigates aviation accidents. Instead, the Office of the National Coordinator for Health Information Technology delegated various monitoring and data collection duties to existing federal offices, including the Agency for Healthcare Research and Quality [AHRQ].</blockquote> The problem is that <a href="http://www.ahrq.gov/" target="_blank">AHRQ</a> is a research agency (as its name suggests), has no regulatory authority nor any experience in regulation, and most clinicians have never heard of it.  In effect, this ONC recommendation is lacking teeth, even compared to the relatively milquetoast recommendations of IOM itself (as I wrote about in a Nov. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html" target="_blank">IOM Report - 'Health IT and Patient Safety: Building Safer Systems for Better Care' - Nix the FDA; Create a New Toothless Agency</a>"). <blockquote class="tr_bq">The [ONC] office has asked patient safety organizations, which work with doctors and hospitals to monitor and analyze medical errors, to add health IT to their agendas. Data from the organizations would be aggregated by the agency, but reporting by doctors and hospitals is completely voluntary.  [A prime example of what I term an extraordinary regulatory accommodation afforded the health IT industry - ed.] </blockquote> Now we're into septic shock blood pressure-level weakness. Here is PA Patient Safety Authority Board Member Cliff Rieders, Esq. on mandatory, let alone voluntary reporting. From “Hospitals Are Not Reporting Errors as Required by Law", Philadelphia Inquirer, pg. 4, <a href="http://articles.philly.com/2008-09-12/news/24991423_1_report-medical-mistakes-new-jersey-hospital-association-medication-safety" rel="nofollow" target="_blank">http://articles.philly.com/2008-09-12/news/24991423_1_report-medical-mistakes-new-jersey-hospital-association-medication-safety:</a>    <blockquote class="tr_bq">... Hospitals don’t report serious events if patients have been warned of the possibility of them in consent forms, said Clifford Rieders, a trial lawyer and member of the Patient Safety Authority’s board. He said he thought one reason many hospitals don’t want to report serious events is that the law also requires that patients be informed in writing within a week of such problems. So, if a hospital doesn’t report a problem, it doesn’t have to send the patient that letter. [Thus reducing risk of litigation, and, incidentally, potentially infringing on patients' rights to legal recourse - ed.] Rieders says the agency has allowed hospitals to determine for themselves what constitutes a serious event and the agency has failed to come up with a solid definition in six years. Fixing this “is not a priority,” he added.</blockquote> To expect hospitals to voluntarily report even a relevant fraction of mistakes and near-misses out of pure altruism, or permit their clinicians to do so, with the inherent risks to organizational interests such reporting entails, is risible. The near-lack of reporting by most health IT sellers and hospitals in the already-existing FDA Manufacturer and User Facility Device Experience (MAUDE) database is substantial confirmation of that; the fraction of reports in MAUDE, however, are hair-raising.  See my Jan. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html" target="_blank">MAUDE and HIT Risks: What in God's Name is Going on Here</a>?" for more on that issue. Here's an example of what happens to 'whistleblowers', even those responsible for system development and safety: "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=lawsuit" target="_blank">A Lawsuit Over Healthcare IT Whistleblowing and Wrongful Discharge</a>." ONC's recommendations thus in my opinion reflect bureaucratic window dressing, designed to create progress - but progress that can probably be measured in microns. <blockquote class="tr_bq">“There was no evidence that a mandatory program was necessary,” Jodi Daniel, the [ONC] office’s director of policy and planning, said in an interview.</blockquote> Really?  See the aforementioned Philadelphia Inquirer article “Hospitals Are Not Reporting Errors as Required by Law", as well as numerous articles on pharma and medical device industry reporting deficits such as starting at page 5 in my paper "A Medical Informatics Grand Challenge: the EMR and Post-Marketing Drug Surveillance" <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Silverstein_Drug_Surveillance.pdf" target="_blank">at this link</a> in PDF. There is no evidence mandatory reporting is necessary ... to someone who's either naïve, incompetent - or persuaded, e.g. with money, to not find evidence or rationale. <blockquote class="tr_bq"> The [ONC] office has been under pressure to roll out the electronic health records systems quickly while protecting patient data and making sure that the systems don’t cause problems in medical care, said Dr. John Halamka, chief information officer at Beth Israel Deaconess Medical Center. </blockquote> Under pressure by the health IT lobby, perhaps; but nobody else that I can think of. <blockquote class="tr_bq">“It’s this challenging chicken-and-egg problem,” he said. </blockquote> No, actually, it isn't.  Patient safety must come first. This becomes clear when one considers the late 5th century BC ethical principle <a href="http://en.wikipedia.org/wiki/Primum_non_nocere" target="_blank">Primum non nocere</a> ("first, do no harm" or "abstain from doing harm") versus the late 20th and early 21st century IT-hyperenthusiast credo I've expressed as "<a href="http://hcrenewal.blogspot.com/2011/10/cybernetik-uber-alles-computers-have.html" target="_blank">Cybernetik Über Alles</a>"  ("Computers above all"). Under CÜA, the computer has more rights than the patients, and the IT industry receives extraordinary regulatory accommodation to sloppy practices that no other healthcare or mission-critical non-healthcare sector enjoys. I sent Dr. Halamka a set of arguments such as I make here, and a picture of a health IT 'chicken', my deceased mother in her death robes. I received back a "thank you for the views" message - but no condolences.  (It occurs that I have rarely if ever received condolences from any senior HIT-hyperenthusiast Medical Informatics academic or government official to whom I've mentioned my mother.  Not to play amateur psychologist, but I believe it reflects the level of disdain or even hatred felt by these people towards health IT iconoclasts/patient's rights advocates.) <blockquote class="tr_bq">The plan, which is subject to public comment through Feb. 4, “is a reasonable start,” in part because it puts more pressure on hospitals and doctors to monitor safety, Halamka said. </blockquote> As I expressed to Dr. Halamka, we are in agreement on that point. <blockquote class="tr_bq"> The government would have risked stifling innovation in the industry if it had opted instead to require the kinds of tests and review by the Food and Drug Administration that new medical devices and drugs must go through, he said.</blockquote> To that, I mention here (as I did in my email to him) my response to this industry meme, as I had expressed it at Q&A after my August 2012 <a href="http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html" target="_blank">keynote address to the Health Informatics Society of Australia</a>: <blockquote class="tr_bq">... I had a question from the audience [after my talk], from fellow blogger <a href="http://thehealthcareblog.com/blog/category/matthew-holt/" target="_blank">Matthew Holt of the Health Care Blog</a>.  (I've had some online debate with him before, such as in the comment thread at my April 2012 post <a href="http://hcrenewal.blogspot.com/2012/04/allscripts-shares-plunge-on-weak.html" target="_blank">here</a>.) Matthew asked me a somewhat hostile question (perhaps in retaliation for the thrashing he received at the end of my May 2009 post on the WaPo's HIT Lobby article <a href="http://hcrenewal.blogspot.com/2009/05/machinery-behind-healthcare-reform-how.html" target="_blank">here</a>), that I was well prepared for, expecting a question along these lines from the seller community, actually.  The question was preceded by a bit of a soliloquy of the "You're trying to stop innovation through regulation" type, with a tad of Merck/VIOXX ad hominem thrown in (I ran Merck Research Labs' Biomedical libraries and IT group in 2000-2003). His question was along the lines of - you were at Merck; VIOXX was bad; health IT allowed discovery of the VIOXX problem by Kaiser several years before anyone else; you're trying to halt IT innovation via demanding regulation of the technology thus harming such capabilities and other innovations. The audience was visibly unsettled.  Someone even hollered out their disapproval of the question. My response was along the lines that: <ul><li>VIOXX was certainly not Merck at its best, but regulation didn't stop Merck from "revolutionizing" asthma and osteoporosis via Singulair and Fosamax;</li><li>That I'm certainly not against innovation; I'm highly pro-innovation;</li><li>That our definitions of "innovation" in medicine might differ, in that innovation without adherence to medical ethics is not really innovation.  It is exploitation.</li></ul></blockquote> I stand by that assessment. More from the Globe article: <blockquote class="tr_bq">There is little good research into how the systems improve health care and there are big obstacles to fixing even the known problems, said Ross Koppel, a professor of sociology at the University of Pennsylvania who studies hospital culture and medication errors. Some developers require providers to sign nondisclosure agreements before using their systems, and the safety plan does not prohibit such gag clauses.  [Note: I wrote on this issue <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda" target="_blank">here</a>, and in a published July 2009 JAMA letter to the editor "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" <a href="http://jama.jamanetwork.com/article.aspx?articleid=184302" target="_blank">here</a> - ed.]  While the plan addresses reporting of known problems, Koppel said it will not help researchers and developers understand problems that go unnoticed but that may be causing real patient harm.  “We only know the tip of the iceberg” about how electronic health records affect patient care, said Koppel, who was an official reviewer for the Institute of Medicine report. </blockquote>As per the title of this blog post, we are in a dark place, ethically, when a PhD sociologist who's never taken the Oath of Hippocrates (to my knowledge) appears to express more concern for patient safety and patient's rights than a Harvard physician-informatics Key Opinion Leader such as Dr. Halamka. <blockquote class="tr_bq">Koppel said the mantra of the Office of the National Coordinator has been that more health IT leads to better health care. “It probably is better than paper,” he said, “but it could be so much better than it is.”</blockquote> I agree, but with caveats.  I opine that bad health IT is likely worse for patients than a good, well-staffed paper based system.  For instance, the former can cause systematic dangers that even a bad paper system cannot, such as tens of thousands of prescription errors (see my Nov, 2011 post "<a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html" target="_blank">Lifespan Rhode Island: Yet another health IT 'glitch' affecting thousands - that, of course, caused no patient harm that they know of - yet</a>") or mass privacy breaches (see the current 30 or so posts on that issue at this blog query link: <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy" target="_blank">http://hcrenewal.blogspot.com/search/label/medical record privacy</a>). On good health IT and bad health IT from my teaching site "Contemporary Issues in Medical Informatics: Good Health IT, Bad Health IT, and Common Examples of Healthcare IT Difficulties" at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/</a>: <blockquote class="tr_bq"> Good Health IT ("GHIT") is IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealthinformation secure, protects patient privacy and facilitates better practice of medicine and better outcomes.  Bad Health IT ("BHIT") is IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, 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> The Boston Globe article concludes: <blockquote class="tr_bq">Ashish Jha, associate professor of health policy at Harvard School of Public Health and a member of the panel that drafted the Institute of Medicine report, said he wants doctors to be able to report problems -- errors in medication lists, for example -- in real-time so they can be found and fixed quickly. The safety plan does not require systems to have that capability, but Daniel said her office could soon add such a requirement for products that receive federal certification. The bigger problem is that health care as a whole needs a better way of tracking patient safety, Jha said. Monitoring issues caused by electronic health records “should be a part of it, and then we can actually know if this is a small, medium or large contributor to patient safety issues,” he said. “But we don’t know that.”</blockquote> I agree with Dr. Jha, but the IT sellers and healthcare organizations will (legitimately) claim that adding real-time error reporting/forwarding to their products will be extremely resource-intensive. I have an alternate approach that will require little effort on the part of the sellers and user organizations. <ul><li>Post a message at the sign-in screen of all health IT along the lines that "This technology is experimental, adopted willingly by [organization] although not rigorously vetted for safety, reliability, usability, nor fitness for purpose, and thus you use it at your own risk.  If problems occur, report them to the following" ...</li></ul> "The following" could include a list of alternatives such as I wrote in my Aug. 2012 post "<a href="http://hcrenewal.blogspot.com/2012/08/clinicians-how-to-document-ehr-screens.html" target="_blank">Clinicians: How to Document the EHR Screens You Encounter That Cause Concern</a>." <div class="date-posts"><div class="post-outer"><div class="post hentry" itemprop="blogPost" itemscope="itemscope" itemtype="http://schema.org/BlogPosting"><a href="http://www.blogger.com/blogger.g?blogID=9551150" name="613349029890366576"></a> <div class="post-body entry-content" id="post-body-613349029890366576" itemprop="description articleBody"><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): <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> </blockquote></div><div class="post-body entry-content" id="post-body-613349029890366576" itemprop="description articleBody">See the actual post for an idea about clinicians seeking indemnification when forced by healthcare organizations to use bad health IT.  I can attest to actually seeing HIT policies that call for "human resources actions" if clinicians refuse to use HIT, or cannot learn to use it at a sufficient pace. (Left out of this reiteration is the demonstration on photographing problematic EHR screens.  See the post for the details - it is easy to do, even with a commodity cellphone.) HHS should be promoting laws on protection from retaliation upon clinicians reporting problems in good faith. Thus, physicians, nurses and other clinicians can create needed health IT transparency and help our society discover the true level of risks of bad health IT.  They simply need the right information on what to do and where to report, bypassing the ONC office and, in the spirit of medicine, taking such matters into their own hands in the interests of patient care and medical ethics. I also made recommendations to the Pennsylvania Patient Safety Authority on how known taxonomies of health IT-related medical error can be used, and need to be used, to promote error reporting in common formats.  Slides from my presentation to the Authority entitled "Asking the Right Questions:  Using Known HIT Safety Issues to Improve Risk Reporting and Analysis", given in July 2012 at their invitation, are at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/PA_patient_safety_Jul2012.ppt" rel="nofollow" target="_blank">http://www.ischool.drexel.edu/faculty/ssilverstein/PA_patient_safety_Jul2012.ppt</a> Finally, another sign of progress:  unlike the HITECH Act, this new ONC plan is open to public comment. -- SS Addendum Jan. 8., 2012: Dr. Halamka has put more details regarding his views in his blog.  The entry is entitled "Electronic Health Record Safety" at this link:  <a href="http://geekdoctor.blogspot.com/2013/01/electronic-health-record-safety.html">http://geekdoctor.blogspot.com/2013/01/electronic-health-record-safety.html .</a> He writes: <blockquote class="tr_bq">... Some have questioned the wisdom of moving forward with EHRs before we are confident that they are 100% safe and secure.   [That, of course, is not my argument - nothing is ever 100% safe and secure.  However, we don't yet know just how safe and secure - or unsafe and insecure - HIT is.  That is the issue I am concerned about - ed.] I believe we need to continue our current implementation efforts. I realize it is a controversial statement for me to make, but let me use an analogy. When cars were first invented, seat belts, air bags, and anti-lock brakes did not exist.    Manufacturers tried to create very functional cars, learned from experience how to make them better, then innovated to create new safety technologies. many of which are now required by regulation. Writing regulation to require seat belts depended on experience with early cars. My grandmother was killed by a medication error caused by lack of an EHR.  My mother was incapacitated by medication issues resulting from lack of health information exchange between professionals and hospitals.   My wife experienced disconnected cancer care because of the lack of incentives to share information.     Meaningful Use Stage 2 requires the functionality in EHRs which could have prevented all three events.</blockquote> I express my condolences on those events. I disagree, however, with continuing national implementation efforts at the current rate, with penalties for non-adopters.  I opine from the perspective of believing health IT has not reached a stage where it is ready for national rollout and remains experimental, its magnitude of harms admittedly unknown and information flows systematically impaired.  I recommend and prefer great caution under those circumstances, and remediation of those circumstances before full-bore national implementation. I will leave it to the reader ponder the two views. -- SS</div></div></div></div>

ONC and "Health IT Patient Safety Action & Surveillance Plan": When Sociologists Uphold the Hippocratic Oath While Physicians Pay Respect to the Lords of Kobol, We Are in a Dark Place, Ethically

[Note: this essay contains many hyperlinks. They can be right-clicked and opened in a separate tab or window.]I've been meaning to write more on the just-before-Christmas, Friday afternoon, minimal-…

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05 Jan 2013

Pennsylvania Patient Safety Authority: The Role of the Electronic Health Record in Patient Safety Events

The <a href="http://patientsafetyauthority.org/Pages/Default.aspx" target="_blank">Pennsylvania Patient Safety Authority</a> has released a report "The Role of the Electronic Health Record in Patient Safety Events."  A press release is <a href="http://www.patientsafetyauthority.org/NewsAndInformation/PressReleases/2012/Pages/pr_December_12_2012.aspx" target="_blank">at this link</a>, and 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 of reported medical errors and identified several major themes. The report was prepared with the assistance of Erin Sparnon, Senior Patient Safety Analyst the <a href="https://www.ecri.org/Pages/default.aspx" target="_blank">ECRI Institute</a> near Philadelphia.  The ECRI Institute 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 techonlogies. Regarding the Patient Safety Authority: <blockquote class="tr_bq">The Pennsylvania Patient Safety Authority was established under Act 13 of 2002, the Medical Care Availability and Reduction of Error ("Mcare") Act, as an independent state agency. It operates under an 11-member <a href="http://patientsafetyauthority.org/PatientSafetyAuthority/Pages/BoardofDirectors.aspx" title="">Board of Directors</a>, six appointed by the Governor and four appointed by the Senate and House leadership. The eleventh member is a physician appointed by the Governor as Board Chair.  Current membership includes three physicians, three attorneys, three nurses, a pharmacist and a non-healthcare worker. The Authority is charged with taking steps to reduce and eliminate medical errors by identifying problems and recommending solutions that promote patient safety in hospitals, ambulatory surgical facilities, birthing centers and certain abortion facilities. Under Act 13 of 2002, these facilities  must report what the Act defines as "Serious Events" and "Incidents" to the Authority. </blockquote> The Authority maintains a database of serious events and incidents: <blockquote class="tr_bq">Consistent with Act 13 of 2002, the Authority developed the Pennsylvania Patient Safety Reporting System (PA-PSRS, pronounced "PAY-sirs"), a confidential web-based system that both receives and analyzes reports of what the Act calls Serious Events (actual occurrences) and Incidents (so-called "near-misses"). </blockquote> Cutting right to the chase, the paper's summary: <blockquote class="tr_bq"> As adoption of health information technology solutions like electronic health records (EHRs) has increased across the United States, increasing attention is being paid to the safety and risk profile of these technologies. However, several groups have called out a lack of available safety data as a major challenge to assessing EHR safety, and this study was performed to inform the field about the types of EHR-related errors and problems reported to the Pennsylvania Patient Safety Authority and to serve as a basis for further study. Authority analysts queried the Pennsylvania Patient Safety Reporting System for reports related to EHR technologies and performed an exploratory analysis of 3,099 reports using a previously published classification structure specific to health information technology. The majority of EHR-related reports involved errors in human data entry, such as entry of “wrong” data or the failure to enter data, and a few reports indicated technical failures on the part of the EHR system. This may reflect the clinical mindset of frontline caregivers who report events to the Authority.</blockquote> Results: <blockquote class="tr_bq">... Reported events were categorized by their reporter-selected harm score (see Table 1). Of the 3,099 EHR-related events, 2,763 (89%) were reported as “event, no harm” (e.g., an error did occur but there was no adverse outcome for the patient) [a risk best avoided to start with, because luck runs out eventually - ed.], and 320 (10%) were reported as “unsafe conditions,” which did not result in a harmful event. Fifteen reports involved temporary harm to the patient due to the following: entering wrong medication data (n = 6), administering the wrong medication (n = 3), ignoring a documented allergy (n = 2), failure to enter lab tests (n = 2), and failure to document (n = 2). Only one event report, related to a failure to properly document an allergy, involved significant harm. </blockquote> A significant "study limitations" section was included that addressed:  <ul><li>Issues regarding reporting statutes of the PA-PSRS errors database; </li></ul><ul><li>lack of awareness of EHRs as a potential contributing factor to an error;</li></ul><ul><li>limitations of narrative reporting affecting both the types of reports queried and the tags applied (the study used textual data mining methodolgies);</li></ul><ul><li>query design of the study; and </li></ul><ul><li>the need for further refinement of the machine learning tool used in creating the working dataset, which may have missed relevant cases.</li></ul> Some of these impediments to knowing the magnitude of extant HIT issues are also present in the 2008 <a href="http://hcrenewal.blogspot.com/2008/12/joint-commission-sentinel-events-alert.html" target="_blank">Joint Commission Sentinel Events Alert on HIT</a>, the <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">2010 FDA internal memorandum on HIT Safety</a>, and the <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html" target="_blank">2011 IOM report</a> on the same topic. (The IOM report specifically observed that the "barriers to generating evidence pose unacceptable risks to safety.")  The major obstacle to this study in my view, though, was the nature of the dataset.  The database is for general reporting of medical errors, and it contains no specific fields or reminders about EHRs or the known ways in which they can contribute to, or cause, medical mistakes.   The attempt was made, as acknowledged in the study, to glean information about EHR-related events from, in large part, textual analysis of narrative in the hopes that the reporter recognized the role of IT, and reported it using terms that could be detected by the search algorithms.  In other words, the data was not "purposed" for this type of study.   It is axiomatic that one cannot find data that is simply not present, no matter how fancy the search algorithm.  Further, passive analysis of clinical IT risk/harms data in an industry where lack of knowledge of causation and misconceptions abound will produce only partial results that suggest further study is needed, and not give an indicator of just how incomplete the results are.  Thus, this cautionary statement was made in the new PA Patient Safety Authority report: <blockquote class="tr_bq">"Although the vast majority of EHR-related reports did not document actual harm to the patient, analysts believe that further study of EHR-related near misses and close calls is warranted as a proactive measure." </blockquote> My comments: The report is welcome. The most important part of the paper, I point out, is the “Limitations” section. FDA, IOM and others have made similar observations – we don’t know the true magnitude of the problem due to systematic limitations of the available data.  Therefore, at best what is available must be deemed as risk management-relevant case reports, a “red flag” that could represent (using the words of FDA CDRH director Jeffrey Shuren regarding HIT safety), the tip of the iceberg. It is imperative far more work be done in post-market surveillance as this technology is deployed nationally and internationally.  This is to ensure that good health IT (GHIT) prevails and bad health IT (BHIT) is either remediated or removed from the marketplace.  I had defined those in other writings as follows: <blockquote class="tr_bq">Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealthinformation secure, protects patient privacy and facilitates better practice of medicine and better outcomes.  </blockquote> <blockquote class="tr_bq">Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, 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> An additional major factor that also contributes to lack of knowledge of EHR-related adverse events is hospital reporting non-compliance. For instance, I know of cases from my own legal consulting work and personal experience that I would have expected to appear in the database, but apparently do not. But don’t take it from me alone. Here is PA Patient Safety Authority Board Member Cliff Rieders, Esq. on this. From “Hospitals Are Not Reporting Errors as Required by Law, Phila. Inquirer”, pg. 4,<a href="http://articles.philly.com/2008-09-12/news/24991423_1_report-medical-mistakes-new-jersey-hospital-association-medication-safety" rel="nofollow" target="_blank">http://articles.philly.com/2008-09-12/news/24991423_1_report-medical-mistakes-new-jersey-hospital-association-medication-safety:</a>    <blockquote class="tr_bq">... Hospitals don’t report serious events if patients have been warned of the possibility of them in consent forms, said Clifford Rieders, a trial lawyer and member of the Patient Safety Authority’s board. He said he thought one reason many hospitals don’t want to report serious events is that the law also requires that patients be informed in writing within a week of such problems. So, if a hospital doesn’t report a problem, it doesn’t have to send the patient that letter. [Thus reducing risk of litigation, and, incidentally, potentially infringing on patients' rights to legal recourse - ed.] Rieders says the agency has allowed hospitals to determine for themselves what constitutes a serious event and the agency has failed to come up with a solid definition in six years. Fixing this “is not a priority,” he added.</blockquote> This coincides with my own personal experience precisely.  In a case where my relative was permanently injured as a result of EHR-related medication error, and then died of the injuries, I never received the required report in writing from the hospital.  I also do not believe the case was reported to the Safety Authority, at least not as IT-related. I suspect the true rates of EHR-related close calls, reversible injuries, permanent injuries and deaths is significantly higher than the limited data available suggests. That data is merely a red flag that much more education, stringent reporting requirements,  templates of known causes of error, and enforcement are needed.  (An April 2010  "thought experiment" on this issue I wrote about at "<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>" certainly suggested as much.) Slides where I made those types of recommendations to the Patient Safety Authority, at a presentation I gave in July 2012 at their invitation, are at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/PA_patient_safety_Jul2012.ppt" rel="nofollow" target="_blank">http://www.ischool.drexel.edu/faculty/ssilverstein/PA_patient_safety_Jul2012.ppt</a> A major concern I have is that the HIT industry will use this new report in a manner that ignores its limitations. (Disclosure: I was an invited reviewer of this new PPSA report.) -- SS  Addendum Dec. 13:    Also worth review is "<a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3243129/" target="_blank">Patient Safety Problems Associated with Heathcare Information Technology: an Analysis of Adverse Events Reported to the US Food and Drug Administration</a>", Magrabi, Ong, Runciman, and Coiera, AMIA Annu Symp Proc. 2011.   Data here came from FDA's voluntary (i.e., also tip of the iceberg) <a class="l" href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm">Manufacturer and User Facility Device Experience</a> (MAUDE) database.  Ironically, the study was done in Australia using Australian grant funds. -- SS

Pennsylvania Patient Safety Authority: The Role of the Electronic Health Record in Patient Safety Events

The Pennsylvania Patient Safety Authority has released a report "The Role of the Electronic Health Record in Patient Safety Events." A press release is at this link, and the full report in PDF is at …

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13 Dec 2012

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