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Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun? I report, you decide.

From the <a href="http://hcrenewal.blogspot.com/2010/08/more-on-huffington-post-investigative.html">aforementioned</a> Huffington Post Investigative Fund article <a href="http://huffpostfund.org/stories/2010/08/fda-obama-digital-medical-records-team-odds-over-safety-oversight">"</a><a href="http://www.huffingtonpost.com/2010/08/04/fda-obama-digital-medical_n_670036.html" style="font-weight: bold;" target="_blank">FDA, Obama Digital Medical Records Team at Odds over Safety Oversight</a><a href="http://huffpostfund.org/stories/2010/08/fda-obama-digital-medical-records-team-odds-over-safety-oversight">"</a> and timeline of industry resistance to government oversight of health IT (<a href="http://web.archive.org/web/20101109120130/http://huffpostfund.org/stories/2010/08/safety-overshadowed" target="_blank">link</a>), one document stands out in my mind. <div dir="ltr">The internal FDA memorandum of Feb. 23, 2010 ("not intended for public use") to Jeffrey Shuren on HIT risks. which I have now re-hosted <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf">at this link</a> (PDF) is quite fascinating. <div style="text-align: center;"><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5501940929848764066" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj2Ha1OH1pZDWOm42XIES7MCCW2pPGLoTGP1Kyj3wqt7HzQ32wRDvdjJi6OwnSjeWp6JyH0EAC7dE9GaRHTphliQHSjkWK7H4MPBwmQ6GgZYIHhLvdy-gmm7Z0B58mtbX18b-_nAFQgUqN0/s320/fda_memo.jpg" style="cursor: pointer; display: block; height: 472px; margin: 0px auto 10px; text-align: center; width: 364px;" /></a>Internal FDA Memo ("not intended for public use") on potential dangers of health IT.  Download the full PDF by clicking <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf">here</a>.</div> The memo begins:</div><blockquote style="margin-bottom: 0px; margin-top: 0px;"><div dir="ltr"> This report serves to characterize medical device reports (MDRs) in the Manufacturer and User Facility Experience (MAUDE) database, inclusive of MedSun reports, pertaining to Health Information Technology (H-IT) safety issues as requested by the Office of the Center Director, Center for Devices and Radiological Health (CDRH), in contrast to the previously submitted MedSun and Office of Compliance information. </div></blockquote><div dir="ltr"></div><div dir="ltr">   (I've mentioned MAUDE <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=MAUDE">here</a> and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=maude_death">here</a>, including a report of an HIT-related patient death at the latter link.) To those "anecdotalists" in the healthcare information technology community who believe reports of HIT-related harm are "anecdotal, and anecdotes don't make data" (as opposed to the "<a href="http://online.wsj.com/article/SB122910977401502369.html?mod=loomia&loomia_si=t0:a16:g2:r3:c0.0175368:b0" target="_blank">Markopolists</a>"): When an internal FDA review of their own data concludes the following, I invite you to think about the point of view that maintains that reports of HIT-related patient injury and death are so 'fragmentary' as to not merit (actually, demand) significant resources be diverted to rigorously addressing the issue of HIT risk:</div><div dir="ltr"></div><blockquote style="margin-bottom: 0px; margin-top: 0px;"><div dir="ltr"> In summary, the results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs and impedes a more comprehensive understanding of the actual problems and implications. </div></blockquote><div dir="ltr"></div><div dir="ltr">   This is especially true considering the FDA's own noted limitations of their information sources:</div><div dir="ltr"></div> <blockquote style="margin-bottom: 0px; margin-top: 0px;"><div dir="ltr">Limitations of the MAUDE search and final subset of MDRs include the following:</div><div dir="ltr"> 1. Not all H-IT safety issue MDRs can be captured due to limitations of reporting practices including</div><div dir="ltr">... (a) Vast number of H-IT systems that interface with multiple medical devices currently assigned to multiple procodes making it difficult to identify specific procodes for H-IT safety issues; ... (b) Procode assignments are also affected by the ability of the reporter/contractor to correctly identify the event as a H-IT safety issue; ... (c) Correct identification by the reporter of the suspect device brand name is challenged by difficulties discerning the actual H-IT system versus the device it supports. 2. Due to incomplete information in the MDRs, it is difficult to unduplicate similar reports, potentially resulting in a higher number of reports than actual events. 3. Reported death and injury events may only be associated with the reported device but not necessarily attributed to the device. Memo: H-IT Safety Issues 4 Correct identification by the reporter of the manufacturer name is convoluted by the inability to discern the manufacturer of the actual H-IT system versus the device it supports. 5 The volume of MDR reporting to MAUDE may be impacted by a lack of understanding the reportability of H-IT safety issues and enforcement of such reporting.</div></blockquote><div dir="ltr">   If HIT were VIOXX or Phen-Fen, the class action lawsuits would likely be starting already. (Note: for more on why there is a scarcity of data on HIT related adverse events, see my paper "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT" at <a href="http://www.scribd.com/doc/28747771/Remediating-an-Unintended-Consequence-of-Healthcare-IT-A-Dearth-of-Data-on-Unintended-Consequences-of-Healthcare-IT">this Scribd link</a>. This paper was not accepted on first draft by the medical informatics peer review process. I received anonymous review comments such as one that paradoxically stated that the paper "did not contain anything that could not be read in any big city newspaper", an odd comment indeed considering the topic. On that basis I decided not to attempt a revision but to post the paper publicly. -- SS) One has to ask why this internal FDA report has not been made public until the Huffington Post article, nor been acted upon vigorously. The term of art is "double standard" compared to pharmaceuticals and other medical devices. When the NEJM starts publishing unreferenced statements of absolute certainty like this from ONC Chair Blumenthal: </div><blockquote style="margin-bottom: 0px; margin-top: 0px;"><div dir="ltr">The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice. </div></blockquote> <div dir="ltr"> and the HuffPo Investigative Fund quotes him as follows: </div><div dir="ltr"></div><blockquote style="margin-bottom: 0px; margin-top: 0px;"><div dir="ltr">“We know that every study and every professional consensus process has concluded that electronic health systems strongly and materially improve patient safety. And we believe that in spreading electronic health records we are going to avoid many types of errors that currently plague the healthcare system,” Blumenthal said when unveiling new regulations in Washington on July 13.</div></blockquote><div dir="ltr"></div><div dir="ltr">   ... a statement easily demonstrable to be without merit, in fact, then one has to wonder <a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html" style="font-weight: bold;" target="_blank">where science has gone</a>. One also has to wonder if someone is short-circuiting the FDA's role in regulating this technology.Could Blumenthal (in essence a family doctor), Sibelius (a trial lawyer), DeParle, or others, or the White House itself be telling FDA how to conduct its business? Are they impeding FDA's regulatory role in the irrationally exuberant multi-billion $$$ race to HIT utopia? Finally, it is my belief that numerous health IT/medical informatics academics and talking heads who've steadfastly avoided the issue of health IT-related patient harm, or scoffed at it in legally-discoverable forums, might find themselves as defendants in upcoming plaintiff lawsuits. "Knew, or should have known" is the phrase that might apply. As I learned from my pre-informatics Transit Authority medical management experience, juries will likely not take kindly to academic and marketing arguments akin to Scott Adam's sarcastic example of the logical fallacy of "ignoring all anecdotal evidence":</div><div dir="ltr"> <blockquote>"I always get hives immediately after eating strawberries. But without a scientifically controlled experiment, it's not reliable data. So I continue to eat strawberries every day, since I can't tell if they cause hives." </blockquote></div><div dir="ltr"></div><div dir="ltr">-- SS</div>

Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun? I report, you decide.

From the aforementioned Huffington Post Investigative Fund article " FDA, Obama Digital Medical Records Team at Odds over Safety Overs...

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More on Huffington Post Investigative Fund: "FDA, Obama Digital Medical Records Team at Odds over Safety Oversight"

Re: today's Huffington Post Investigative Fund article "<a href="http://huffpostfund.org/stories/2010/08/fda-obama-digital-medical-records-team-odds-over-safety-oversight">FDA, Obama Digital Medical Records Team at Odds over Safety Oversight</a>." (I'd written some preliminary comments at an earlier post entitled "<a style="font-style: italic;" href="http://hcrenewal.blogspot.com/2010/08/huffington-post-investigative-fund-fda.html">Huffington Post Investigative Fund: FDA, Obama Digital Medical Records Team at Odds over Safety Oversight</a>.") First, some relatively obvious questions about the Cerner health IT crashes at the <a href="http://www.trinity-health.org/index.htm">Trinity Health System</a> chain of hospitals featured in the story: <ul><li>How many patients were affected? Is the number actually known?</li><li>Were affected patient charts corrected? </li><li>What restrictions, if any, have been placed on physicians, other clinicians, employees, contractors, staff, etc. about speaking to the press on the Trinity Health HIT malfunctions?</li><li>If any restrictions were placed, are they in violation of Joint Commission Safety Standards as in my July 22, 2009 JAMA letter to the editor "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" <a href="http://jama.ama-assn.org/cgi/content/extract/302/4/382">at this link</a>?</li><li>Did this healthcare system sign "hold harmless" clauses with Cerner, as per Koppel and Kreda's 2009 JAMA article "Health Care Information Technology Vendors' Hold Harmless Clause - Implications for Patients and Clinicians, JAMA 2009;301(12):1276-1278, at <a href="http://jama.ama-assn.org/cgi/content/extract/301/12/1276">this link</a>? </li><li>Did this healthcare system sign a gag clause with Cerner, the vendor of their affected systems according to the Huffington Post article?</li><li>Medical adverse events from medical record errors can occur quickly, or be more delayed. If patient harm comes of the IT errors that occurred, will the healthcare system file a public report?</li></ul> Now, on to some specific comments and observations on the Huffington Post Investigative Fund article. The Huffington Post article begins: <blockquote>Computers at a major Midwest hospital chain went awry on June 29, posting some doctors’ orders to the wrong medical charts in a few cases and possibly putting patients in harm’s way. The digital records system “would switch to another patient record without the user directing it to do so,” said Stephen Shivinsky, vice-president for corporate communications at Trinity Health System. Trinity operates 46 hospitals, most in Michigan, Iowa and Ohio.</blockquote> The bolded passage sounds like obfuscatory PR language, as if the EMR system changed the window focus to another patient's window (people do this all the time when they have multiple windows open in a GUI). If so, that would not be a major problem - the user would just switch back via clicking on the desired window. Let's state what it sounds like the problem really was with crystal clarity: Data a clinician entered into the window of primary focus (say, on Mary Jones) would end up in the electronic record of a window that was not the window of primary focus and in the background (say, that of Tom Smith). The clinician would be unaware this had occurred, and two errors would then occur. The first error was that appropriate data would be missing for Mary. The second is that inappropriate data would be present for Tom. These events put both patients at risk of medical error. <blockquote>Less than two weeks later, an unrelated glitch caused Trinity to shut down its $400 million system for four hours at 10 hospitals in the network because electronic pharmacy orders weren’t being delivered to nurses for dispensing to patients, he said.</blockquote> Was this 'glitch' [a code word for "we are not in control of our system, it is in control of us" - ed.] related to the problem above? If so, that would suggest major system problems deep within its code. If not, it suggests lax overall quality control of this IT. <blockquote> “As soon as it was brought to our attention, we moved to fix the problem,” Shivinsky said of Trinity’s system </blockquote> This statement says nothing. One would not expect them to wait to fix a potentially dangerous problem. <blockquote>He said nobody was injured in either event, ...</blockquote> As in my prior post, the correct statement would be: <blockquote>Nobody was injured, yet, due to the errors. </blockquote> ... the Cerner Corp. system now works properly, Does that mean all the problems are fixed? The article implies not via its ending where Shivinsky is quoted that: <blockquote>... Meanwhile technicians are still trying to figure out the root cause. “We’ll get to the bottom of it and fix it,” he said. </blockquote>By the way, I note the following employee reporting site on Cerner's environment: <a href="http://www.jobvent.com/cerner-corp--job-reviews-C1174">link</a>. Could this be a factor in Richard Granger, the former head of the UK's NHS national IT programme <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=granger_speaks_out">saying that</a>: <blockquote> "Sometimes we put in stuff that I'm just ashamed of ... Some of the stuff that Cerner has put in recently is appalling ... Cerner and prime contractor Fujitsu had not listened to end users ... Failed marriages and co-dependency with subcontractors ... A string of problems ranging from missing appointment records, to inability to report on wait times ... Almost a dozen cancelled go-live dates ... Stupid or evil people ... Stockholm syndrome -identifying with suppliers' interests rather than your own ... A little coterie of people out there who are "alleged experts" who were dismissed for reasons of non-performance."</blockquote> I can only wonder. <blockquote>... and the hospital chain determined that “technician error” led to the system shutdown and that the mixing up of patients was the result of a “Cerner coding issue” involving software that occurred after an upgrade.</blockquote> What was the "technician" doing that led to the shutdown, what was the technician's background and qualifications to be doing it to a mission critical medical device? Further, what, exactly, was the "Cerner coding issue?" Was it Cerner's fault? Trinity's? Both? Were other organizations using the same software similarly affected? How will other healthcare organizations learn if the cause of the problems is not revealed? <blockquote>Even absent any harm to patients, such incidents underscore possible risks faced by even large health organizations that have eagerly embraced new medical software to track patient records and treatment. As the Obama administration ramps up plans to create a digital medical file for every American by 2014 – at an anticipated tab to taxpayers of up to $27 billion – technology’s boosters tend to tout its potential benefits to patients and ability to slow runaway medical costs.</blockquote> That's not been my observation. Look at the UK for instance: <blockquote>The <st1:place st="on"><st1:country-region st="on">UK</st1:country-region></st1:place> Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program is <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">here</a>. <o:p></o:p> Gateway reviews of the UK National Programme for IT from the Office of Government Commerce (OGC) are <a href="http://www.connectingforhealth.nhs.uk/about/foi">here</a> (released under the UK’s Freedom of Information Act), and a summary of 16 key points is <a href="http://www.computerweekly.com/blogs/tony_collins/2009/06/16-key-points-in-gateway-revie.html">here</a>.</blockquote> I wish there were strong documentary evidence on the latter point about major savings, and that there wasn't evidence to the contrary. The healthcare system doesn't have enough spare capital to throw away on the hopes some touted technology (from which an industry stands to make billions) is a panacea. <blockquote> Yet despite the high political and financial stakes, the administration has established no national mandatory monitoring procedure for the new devices and software. That no process exists to report and track errors, pinpoint their causes and prevent them from recurring is largely the result of two decades of resistance by the technology industry, a review of government records and interviews by the Huffington Post Investigative Fund shows. The industry argues that even with flaws, digital systems are an improvement over current paper records.</blockquote> That is no excuse for decades of toleration of the flaws. It is an amoral position. As at my July 28 post <a href="http://hcrenewal.blogspot.com/2010/07/open-question-on-moral-authority-and.html">"An Open Question on Moral Authority and Healthcare IT"</a>, it is playing God. The HuffPo article continues: <blockquote> “There’s an assumption that just because you have an electronic system, it’s going to be safer, so people let down their guards,” said Vimla Patel, who directs research on the topic at the University of Texas Health Science Center in Houston.</blockquote> It's not an "assumption." This meme has been pushed so long by the HIT industry and its irrationally exuberant, uncritical supporters, it's become an accepted statement of fact - as per my July 14 post <a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html">"Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records"</a> where the Chairman of ONC states it as fact in the New England Journal of Medicine, with nary a footnote to back it up: <blockquote>Blumenthal - The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.</blockquote> That's pretty definitive. If there's a trace of doubt, I don't see it. <blockquote>Monitoring could help others learn from problems faced by early users of the technology, which is being sold nationally, or how they were remedied. Shivinsky said he wasn’t sure if federal officials had been notified of the difficulties at Trinity — or would be. No rule requires it.</blockquote> Why is there no rule? What if this were a medical device such as a CT scanner, or heart defibrillator? Why does health IT get special accommodation when it is now a regulator and governor of clinician communications and actions, placed in between clinician and patient? <blockquote>Almost a month after the first event at Trinity, David Blumenthal, the government’s top medical health information technology official, didn’t know about it. “First I’ve heard about it,” Blumenthal said when told by a reporter July 20, as he left a Capitol Hill hearing. Since then, Blumenthal has declined to discuss the incident or its implications. </blockquote> That's perhaps because it conflicts with his other assertions on health IT technological determinism, noted above. How many other "events" is he aware of? <blockquote>Kelli Christman, a spokesman for Cerner, the manufacturer of the software used at Trinity, did not respond to repeated emails and phone calls over the past week seeking comment.</blockquote> What are they hiding? Perhaps other affected healthcare systems? <blockquote>... Many industry groups contend that FDA regulation would “stifle innovation” and stall the national drive to wire up American medicine. That view resonates among the dozens of health information technology experts serving as consultants to Blumenthal’s office and on advisory groups. Blumenthal also has been skeptical of the need for regulation and argued that even if some miscues occur, digital systems are far less prone to error than paper ones.</blockquote> In an industry with contractual gag clauses and clinician fear of speaking about HIT problems (e.g., of retaliation by hospital officials), how can anyone be sure of this? Is this a scientific statement, or a marketing position? See may paper <a href="http://www.scribd.com/doc/28747771/Remediating-an-Unintended-Consequence-of-Healthcare-IT-A-Dearth-of-Data-on-Unintended-Consequences-of-Healthcare-IT" class="title">"Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT</a>" for more on this issue. <blockquote> “We know that every study and every professional consensus process has concluded that electronic health systems strongly and materially improve patient safety. And we believe that in spreading electronic health records we are going to avoid many types of errors that currently plague the healthcare system,” Blumenthal said when unveiling new regulations in Washington on July 13.</blockquote> This statement is without merit, as per my prior post "<a href="http://hcrenewal.blogspot.com/2010/08/huffington-post-investigative-fund-fda.html">Huffington Post Investigative Fund: FDA, Obama Digital Medical Records Team at Odds over Safety Oversight</a>." Further: note to Dr. Blumenthal: <a href="http://www.s8int.com/crichton.html">Consensus is not science</a>: <blockquote> [Chrichton, Caltech Michelin Lecture, 2003] ... I want to pause here and talk about this notion of consensus, and the rise of what has been called consensus science. I regard consensus science as an extremely pernicious development that ought to be stopped cold in its tracks. Historically, the claim of consensus has been the first refuge of scoundrels; it is a way to avoid debate by claiming that the matter is already settled. Whenever you hear the consensus of scientists agrees on something or other, reach for your wallet, because you're being had. Let's be clear: the work of science has nothing whatever to do with consensus. Consensus is the business of politics. Science, on the contrary, requires only one investigator who happens to be right, which means that he or she has results that are verifiable by reference to the real world. In science consensus is irrelevant. What is relevant is reproducible results. The greatest scientists in history are great precisely because they broke with the consensus. There is no such thing as consensus science. If it's consensus, it isn't science. If it's science, it isn't consensus. Period</blockquote> Blumenthal goes on: <blockquote>In public remarks that day, Blumenthal said he “expects” an eventual certification process for the digital systems to “collect information about the problems that occur with the implementation of electronic health records, if any.” He did not say when that would happen. </blockquote> Eventual? Why not NOW, considering that the HIT industry has been in business for decades? The infrastructure for such reporting already exists, such as the <a href="http://www.fda.gov/Safety/MedWatch/default.htm">FDA MedWatch</a> system and <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm">Manufacturer and User Facility Device Experience</a> (MAUDE) database - where, by the way, an HIT-related death was reported (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=maude_death">link</a>). Imagine the aviation, nuclear energy industry or pharma making such outrageous statements about getting around to collecting information on potentially hazardous flaws "eventually." <blockquote>In a later interview, Blumenthal said “safety concerns are not being ignored,” but wouldn’t comment further.</blockquote> Yes, they are being ignored. Worse, they're being suppressed as in this case example, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=lawsuit">"A Lawsuit Over Healthcare IT Whistleblowing and Wrongful Discharge: Malin v. Siemens Healthcare</a>." <blockquote> ... Dozens of other health information technology insiders, from academics to front-line users who believe digital medical records can promote better and cheaper health care, told the Investigative Fund in interviews that they nonetheless fear safety issues will mount as doctors and hospitals move quickly to install the systems and collect stimulus checks.</blockquote> Just anecdotal, according to ONC and others. <blockquote>“People just assume that computers will make things safer,” said Nancy Leveson, a safety engineering expert at Massachusetts Institute of Technology. “While they can be designed to eliminate certain kinds of hazards, they increase others and sometimes they introduce new types of hazards.”</blockquote> This is a principle direct from the discipline of <a href="http://rkcsi.indiana.edu/archive/SI/Arts/SI_report_Aug_14.doc">Social Informatics</a>. Social Informatics (SI) refers to the body of research and study (e.g,, as collected <a href="http://rkcsi.indiana.edu/">here</a>) that examines social aspects of computerization, including the roles of information technology in social and organizational change, the uses of information technologies in social contexts, and the ways that the social organization of information technologies is influenced by social forces and social practices. <blockquote>Some experts are calling for closer government monitoring of the systems to protect the public. “We need to have some scrutiny at the front end and have an approval process to make sure they are safe before they’re deployed,” said Sharona Hoffman, a law professor at Case Western Reserve University, who has written about the issue in academic journals.</blockquote> I am one of those experts, and I agree. <blockquote>... In 2004, digital record keeping got a boost when President George Bush signed an executive order to create a digital medical file for every American within a decade, a goal officials said at the time they could reach “without substantial regulation.” “The time wasn’t right at that time to move forward or the support wasn’t there (for safety regulations),” said Robert Kolodner, who ran the national coordinator’s office during some of the Bush years.</blockquote> Again, I ask - why the hell not? When is a good time to discuss healthcare and HIT safety? Would such attitudes be tolerated in other industries? I dare say, hell no. <blockquote>Edward H. Shortliffe, president of the American Medical Informatics Association and a longtime industry figure, agreed that safety issues weren’t a “primary concern” as tech companies began to expand their offerings.</blockquote> That is a startling revelation - it could be the basis for medical malpractice plaintiff lawsuits on the basis of negligence, all the way to <a href="http://www.answers.com/topic/criminal-negligence">criminally negligent homicide</a> if a patient dies of an HIT-related event. <blockquote><a style="font-weight: bold;" href="http://www.answers.com/topic/criminal-negligence">Criminal negligence</a>: The failure to use reasonable care to avoid consequences that threaten or harm the safety of the public and that are the foreseeable outcome of acting in a particular manner.</blockquote> The HuffPo article further observes: <blockquote> Earlier this year, the [health IT] trade group convened an expert panel to study the issues for the first time, but its findings have yet to be made public. Shortliffe said he didn’t think the organization would take a stand on government regulation of the industry, but said: “We recognize that there are significant challenges that the field as a whole is facing.”</blockquote> The "first time" in an industry messing with people's medical care for decades? How is this possible? <blockquote>... ONC director Blumenthal, the point man for the administration, has called the FDA’s injury findings “anecdotal and fragmentary.” </blockquote> Just how many "anecdotes" do we need in an industry that places gag clauses on health IT users? [March 2011 addendum - see thoughts on health IT "anecdotes" at this posting: <a href="http://hcrenewal.blogspot.com/2011/03/those-who-dismiss-heathcare-and-healht.html">Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost, Supreme Court-Style</a> - ed.] <blockquote> He told the Investigative Fund that he believed nothing in the report indicated a need for regulation [i.e., absence of evidence in a tight-lipped industry as evidence of absence - ed.] Yet others see anecdotes as a starting point for a more methodical look at problems that arise.</blockquote> Who is more attuned to risk mitigation when they see red flags? Who are the clinician scientists, and who are the "see no evil, hear no evil, speak no evil" politicians? <blockquote>The same day that Blumenthal, Sebelius and other federal health officials unveiled their digital records plan in Washington, an obscure government agency held a conference less than 20 miles away in suburban Maryland to discuss the state of quality controls. Ben-Tzion Karsh, an engineering professor at the University of Wisconsin in Madison who attended the National Institute of Standards and Technology conference said he heard a “broad consensus” among experts that electronic medical records need to function better and safer. “The truth is that we do not at this time know what would make an EHR (electronic health record) safe,” he said. Others said that despite the rosy view taken by many political figures in Washington, many systems on the market today aren’t designed in ways that prevent and limit new errors—and that nobody is holding the industry accountable.</blockquote><div style="overflow: hidden; color: rgb(0, 0, 0); background-color: transparent; text-align: left; text-decoration: none; border: medium none;"> </div>Again I ask: how is this possible after decades of this industry's selling of products to hospitals for use on actual patients? Also, the simple question arises: is this technology truly ready for the ambitious national roll out plans of the past two administrations? I've touched on many of these issues in past years on this blog and at my <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases">academic website on HIT problems</a>. I see a clear runaway train and train wreck headed down the tracks. The next few years in health IT should prove interesting indeed. -- SS

More on Huffington Post Investigative Fund: "FDA, Obama Digital Medical Records Team at Odds over Safety Oversight"

Re: today's Huffington Post Investigative Fund article " FDA, Obama Digital Medical Records Team at Odds over Safety Oversight ....

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A Few Additional Comments on the GE Radiation Debacle

Roy Poses beat me to posting about the General Electric CT over-irradiation debacle (<a href="http://hcrenewal.blogspot.com/2010/08/ge-dont-know-much-about-radiation.html">GE: Don't Know Much About Radiation Safety, Don't Know Much About Physics</a>). I am going to add two points: Point 1: The National Research Council in its <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">2009 report on health IT</a> warned that "current approaches to healthcare IT are insufficient", and one of the major caveats was that: <blockquote> ... greater emphasis should be placed on information technology that provides health care workers and patients with cognitive support, such as assistance in decision-making and problem-solving.</blockquote> In fact the lack of cognitive support for clinicians was one of the report's major themes. "Cognitive support" by definition means producing devices (whether physical or virtual) that are intended for busy clinical settings where situations often resemble a madhouse - not calm, solitary office environments (borrowing from Joan Ash's <a href="http://www.eurekalert.org/pub_releases/2003-11/ohs-mhd112403.php">findings on CPOE flaws</a>): <blockquote>"Many information systems simply don't reflect the health care professional's hectic work environment with its all too frequent interruptions from phone calls, pages, colleagues and patients. Instead these are designed for people who work in calm and solitary environments. This design disconnect is the source of both types of silent errors …Some patient care information systems require data entry that is so elaborate that time spent recording patient data is significantly greater than it was with its paper predecessors," the authors wrote. "What is worse, on several occasions during our studies, overly structured data entry led to a loss of cognitive focus by the clinician." </blockquote> It does not mean, as reported on July 31, 2010 in the <a href="http://www.nytimes.com/2010/08/01/health/01radiation.html?pagewanted=3&_r=1">New York Times</a>, that designers and vendors of these medical devices should take the stance of blaming the user: <blockquote>A GE spokesman, Arvind Gopalratnam, said the way scanners were programmed was “determined by the user and not the manufacturer.” GE, he added, has no record of Glendale seeking its help setting up the new procedure in 2009. ... GE says the hospitals should have known how to safely use the automatic feature. Besides, GE said, the feature had “limited utility” for a perfusion scan because the test targets one specific area of the brain, rather than body parts of varying thickness. In addition, experts say high-clarity images are not needed to track blood flow in the brain. GE further faulted hospital technologists for failing to notice dosing levels on their treatment screens. But representatives of both hospitals said GE trainers never fully explained the automatic feature. </blockquote> Imagine the reaction if Boeing blamed pilots for collisions if those pilots, busy with other matters, were only alerted to an impending collision via a range reading on their cluttered instrument panel - rather than a LOUD AUDIBLE ALARM - such as WARNING, WARNING, COLLISION IMMINENT. Point 2: What's really missing here was attention to cognitive support for busy clinicians. This, of course, requires proper senior management - senior management with the appropriate expertise. Proper senior management then controls talent management down the chain of an organization. If the leaders "don't know nothing 'bout trigonometry", they will be less likely to put mathematicians in appropriate leadership roles. If management doesn't understand Medical Informatics, they will be less likely to put informaticists into leadership roles as well. One major focus of Medical Informatics is cognitive support of busy clinicians in their all too real-world environments. Why might the latter point be relevant at GE? In 1999 after working for a competitor of GE, Comdisco Healthcare Group, who among other business aspects reconditioned and resold capital equipment such as CT scanners, I wrote this in an essay on "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/informaticsmd/infordef1.htm#isnot">what medical informatics is not</a>": <blockquote>... I've noted a number of large vendors and even national medical organizations whose so-called "Medical Informatics Directors" had neither clinical backgrounds nor training in medical informatics (nor in information science of any kind). MIS managers, social workers, and clinicians with no more experience than some tinkering with a home Macintosh can be found as "Directors of Medical Informatics" in the (unfortunately) unregulated healthcare IT industry. Sometimes the term is used as a sales slogan. General Electric displayed a huge banner over their booth proclaiming themselves "the world leader in Radiology Informatics" at the 1999 <a href="http://www.rsna.org/">Radiological Society of North America</a> (RSNA) conference in Chicago. Unfortunately, nobody present, including sales, management, and engineering representatives, could explain to me what that term meant. They actually said they did not know. I had only identified myself as a physician at that point, not as a medical informatics professional, and expressed incredulity on nobody being able to explain the banner to me. Under pressure, one GE engineer offered the statement "I think it has something to do with computers attached to our x-ray machines." </blockquote> It's now 2010. It seems GE still may not know what Medical Informatics is. Handing busy clinical end users a revolver with a single bullet in the chamber, and asking them to play Russian Roulette under busy circumstances with a warning to "check the chamber carefully each time before you pull the trigger", is simply unacceptable for computerized medical device design. -- SS

A Few Additional Comments on the GE Radiation Debacle

Roy Poses beat me to posting about the General Electric CT over-irradiation debacle ( GE: Don't Know Much About Radiation Safety, Don...

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GE: Don't Know Much About Radiation Safety, Don't Know Much About Physics

Don't know much about history Don't know much biology Don't know much about a science book Don't know much about the french I took. (<a href="http://artists.letssingit.com/sam-cooke-lyrics-wonderful-world-wzxlmlw">Wonderful World</a>, sung by Sam Cook) This is becoming the theme song for executives of health care corporations.  We have posted about a series of cases in which major health care corporations suddenly seemed unable to carry out their core business functions, a phenomenon I am going to start calling "core business incompetence."  Some recent examples: -  Baxter International apparently failed to check the purity of heparin it bought from a foreign supplier; the contaminated heparin resulted in approximately 81 deaths. (See post <a href="http://hcrenewal.blogspot.com/2010/07/more-about-what-we-dont-know-about.html">here</a>.) -  A major Genzyme manufacturing facility had multiple quality problems, resulting in the production of a very expensive, but contaminated biologic medication. (See post <a href="http://hcrenewal.blogspot.com/2010/05/genzyme-settles.html">here</a>.) -  Three Johnson and Johnson manufacturing facilities had multiple quality problems, resulting in the production of contaminated batches of over-the-counter medications for children. (See post <a href="http://hcrenewal.blogspot.com/2010/07/are-ill-informed-leaders-cause-of-drug.html">here</a>.) -  Aetna made mathematical errors in computing the rates it proposed charging; WellPoint made computer errors that exposed sensitive policy-holder information.  (See blog post <a href="http://hcrenewal.blogspot.com/2010/06/wellpoint-dont-know-much-about-computer.html">here</a>.) Manufacturing pure, unadulterated medicines is a core function of a drug company.  Correctly calculating policy-costs and correctly handling patient data are core functions of health insurance companies.  But in the above cases, three large pharmaceutical companies and two large insurance companies could not perform these core functions competently. Radiation Sickness from CT Scans In the last few days, more details of what appears to be another example of core incompetency afflicting a major health care organization has surfaced.  The details were <a href="http://www.nytimes.com/2010/08/01/health/01radiation.html">reported</a> by Walt Bogdanich in the New York Times. Here is the summary: <blockquote>When Alain Reyes’s hair suddenly fell out in a freakish band circling his head, he was not the only one worried about his health. His co-workers at a shipping company avoided him, and his boss sent him home, fearing he had a contagious disease. Only later would Mr. Reyes learn what had caused him so much physical and emotional grief: he had received a radiation overdose during a test for a stroke at a hospital in Glendale, Calif. Other patients getting the procedure, called a CT brain perfusion scan, were being overdosed, too — 37 of them just up the freeway at Providence Saint Joseph Medical Center in Burbank, 269 more at the renowned Cedars-Sinai Medical Center in Los Angeles and dozens more at a hospital in Huntsville, Ala. The overdoses, which began to emerge late last summer, set off an investigation by the Food and Drug Administration into why patients tested with this complex yet lightly regulated technology were bombarded with excessive radiation. After 10 months, the agency has yet to provide a final report on what it found. But an examination by The New York Times has found that radiation overdoses were larger and more widespread than previously known, that patients have reported symptoms considerably more serious than losing their hair, and that experts say they may face long-term risks of cancer and brain damage. </blockquote> So not to mince words, in this sad case, many patients seem to have been subject to radiation poisoning from a diagnostic x-ray procedure (not from radiation therapy for cancer.)  Most people (and physicians) may have not previously thought that radiation poisoning was a possible harm from a single diagnostic CT scan. A Design Failure? Moreover, it appears that the radiation poisoning did not result from some freak accidents or malfunction: <blockquote>The review also offers insight into the way many of the overdoses occurred. While in some cases technicians did not know how to properly administer the test, interviews with hospital officials and a review of public records raise new questions about the role of manufacturers, including how well they design their software and equipment and train those who use them. </blockquote> Also, <blockquote>None of the overdoses can be attributed to malfunctions of the CT scanners, government officials say. At Glendale Adventist Medical Center, where Mr. Reyes and nine others were overdosed, employees told state investigators that they consulted with GE last year when instituting a new procedure to get quicker images of blood flow, state records show. But employees still made mistakes. As a result, hospital officials said, a feature that technicians thought would lower radiation levels actually raised them. Cedars-Sinai gave a similar explanation. 'There was a lot of trust in the manufacturers and trust in the technology that this type of equipment in this day and age would not allow you to get more radiation than was absolutely necessary,' said Robert Marchuck, the Glendale hospital’s vice president of ancillary services. A GE spokesman, Arvind Gopalratnam, said the way scanners were programmed was 'determined by the user and not the manufacturer.' GE, he added, has no record of Glendale seeking its help setting up the new procedure in 2009. Most of the known overdoses, including the biggest, occurred on scanners made by GE Healthcare. At two hospitals that use Toshiba scanners — Los Angeles County-U.S.C. and South Lake in Florida — officials said the manufacturer suggested machine settings that ultimately produced too much radiation. Representatives of Toshiba agreed to be interviewed in their California office but abruptly canceled. </blockquote> In particular, <blockquote>To this day, no one at Cedars-Sinai knows who programmed the scanners that delivered the overdoses, officials there say. But in written statements to The Times, hospital officials said they had figured out how they might have occurred. Normally, the more radiation a CT scan uses, the better the image. But amid concerns that patients are getting more radiation than necessary, the medical community has embraced the idea of using only enough to obtain an image sufficient for diagnosis. To do that, GE offers a feature on its CT scanner that can automatically adjust the dose according to a patient’s size and body part. It is, a GE manual says, 'a technical innovation that significantly reduces radiation dose.' At Cedars-Sinai and Glendale Adventist, technicians used the automatic feature — rather than a fixed, predetermined radiation level — for their brain perfusion scans. But a surprise awaited them: when used with certain machine settings that govern image clarity, the automatic feature did not reduce the dose — it raised it. As a result, patients at Cedars-Sinai received up to eight times as much radiation as necessary, while the 10 overradiated at Glendale received four times as much, state records show. GE says the hospitals should have known how to safely use the automatic feature. Besides, GE said, the feature had 'limited utility' for a perfusion scan because the test targets one specific area of the brain, rather than body parts of varying thickness. In addition, experts say high-clarity images are not needed to track blood flow in the brain. GE further faulted hospital technologists for failing to notice dosing levels on their treatment screens. But representatives of both hospitals said GE trainers never fully explained the automatic feature. In a statement, Cedars-Sinai said that during multiple training visits, GE never mentioned the 'counterintuitive' nature of a feature that promises to lower radiation but ends up raising it. The hospital also said user manuals never pointed out that the automatic feature was of limited value for perfusion scans. A better-designed CT scanner, safety experts say, might have prevented the overdoses by alerting operators, or simply shutting down, when doses reached dangerous levels. </blockquote> Summary: Core Incompetence To summarize, GE diagnostic CT scan machines apparently were designed so that they could deliver so much radiation that their use could cause radiation sickness. The machines had no built in safeguards to limit the dose of radiation. Users, that is, X-ray technicians, could program the machine so as to deliver dangerous radiation doses, but GE did not warn them that this was the case, nor provide a machine feature that would give a real-time warning of incipient overdose. Thus it appears that GE, which has been <a href="http://www.boston.com/business/technology/articles/2010/08/03/ge_intel_form_chronic_care_venture/">described</a> as "the world’s biggest maker of health care imaging and information technology systems," failed in its core function of designing and manufacturing safe diagnostic x-ray machines. (Presumably the same might be said of Toshiba, but the NY Times report does not include so much detail about problems with its machines.) A straightforward explanation of the magnitude of the core incompetence was provided by one of the patients who got radiation sickness: <blockquote>To Mr. Heuser, it is unconscionable that equipment able to deliver such high radiation doses lacks stronger safety features. 'When you are in a car and it backs up, it goes beep, beep, beep,' he said. 'If you fill the washing machine up too much, it won’t work. There is no red light that says you are overradiating.' </blockquote> It really seems like we are seeing an epidemic of core incompetence by major US health care corporations. I can only speculate about why this occurring. One explanation is that the organizations may be lead by people who do not understand the health care context, and do not understand the scientific, engineering, and technical issues involved with core competence. Many health care corporations have come to be lead by people with no experience or background in relevant areas. For example, the current, and often acclaimed CEO of GE is <a href="http://www.ge.com/company/leadership/ceo.html">Jeffrey Immelt</a>, who "earned a B.A. degree in applied mathematics from Dartmouth College in 1978 and an M.B.A. from Harvard University in 1982." The leader of GE Healthcare is <a href="http://www.ge.com/company/leadership/bios_exec/john_dineen.html">John Dineen</a>, who "is a graduate of the University of Vermont where he earned Bachelor's degrees in biology/genetics and computer science," and "joined GE in 1986 as a telecommunications engineer." Another, even more speculative explanation is that many major US and global health care organizations seem to have been infected with the virus of putting short-term financial results ahead of everything else, leading to cutting of costs and particularly human expertise in the areas most core to the organizations' functions, and pushing for hurried results even at the expense of clear thinking, carefully engineering, and consideration of the effects on patients and other humans of the resulting mistakes. Hopefully, further investigation will reveal more about what went wrong in this case. Meanwhile, I say again, again, again,... As long as "imperial CEOs" can continue to get extremely rich while presiding over incompetence and stupidity, if not worse), we can expect the foolishness to continue. Meanwhile, the foolishness drives up costs and drives down quality of health care for the poor suffering patients, let alone the physicians and other health care professionals who must deal with it. To really reform health care, we need to provide incentives for competent, honest leadership, and make that leadership accountable for its shortcomings. Postscript - Why the Rush to Aggressive Treatment? The NY Times article described the rush to get one of the afflicted patients to the CT scan: <blockquote>on the morning of July 4, when a 52-year-old executive producer of films, H. Michael Heuser, arrived in the emergency department with stroke symptoms. A 'code brain' was immediately called, signaling a life-or-death situation. A blood clot in the brain can be dissolved with medicine, but doctors must do it within several hours, before brain cells die from a lack of oxygen. So Mr. Heuser was rushed into a room with several CT scanners, where he underwent one brain perfusion study and at least one more later. A CT perfusion scan, which lasts about 45 seconds, can identify a stroke through a series of blood flow images. Mr. Heuser did have a stroke, from which he would recover. But other parts of his body inexplicably began to break down. </blockquote> However, there is no clear evidence that such a rapid and drastic approach is really that good for patients. A recently updated <a href="http://www.ncbi.nlm.nih.gov/pubmed/18843603">Cochrane review </a>concluded: "In patients with acute ischaemic stroke, immediate anticoagulant therapy is not associated with net short or long-term benefit. Treatment with anticoagulants reduced recurrent stroke, deep vein thrombosis and pulmonary embolism, but increased bleeding risk. The data do not support the routine use of any the currently available anticoagulants in acute ischaemic stroke." However, many physicians seem to advocate the drastic approach based on some controlled trials that showed at best small improvements in average neurological function for patients receiving rapid anti-coagulation (and which were done before anyone thought about radiation sickness as a possible harm of the approach.) Once again, an aggressive, technological, expensive approach, possibly advocated by people who stood to gain financially from it, may not be as advantageous as it appears.

GE: Don't Know Much About Radiation Safety, Don't Know Much About Physics

Don't know much about history Don't know much biology Don't know much about a science book Don't know much about the french ...

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Huffington Post Investigative Fund: FDA, Obama Digital Medical Records Team at Odds over Safety Oversight

<div style="text-align: center;">(Note: also see my followup post "<a href="http://hcrenewal.blogspot.com/2010/08/more-on-huffington-post-investigative.html">More on Huffington Post Investigative Fund: "FDA, Obama Digital Medical Records Team at Odds over Safety Oversight"</a>) </div> The Huffington Post Investigative Fund has published a remarkable expose of health IT difficulties and the Big Politics that surround them regarding safety and efficacy: <a href="http://huffpostfund.org/stories/2010/08/fda-obama-digital-medical-records-team-odds-over-safety-oversight"></a><blockquote><a href="http://huffpostfund.org/stories/2010/08/fda-obama-digital-medical-records-team-odds-over-safety-oversight">FDA, Obama Digital Medical Records Team at Odds over Safety Oversight</a> Aug. 3, 2010 By <a title="View user profile." href="http://huffpostfund.org/users/fredschulte" jquery1280932414984="124">Fred Schulte</a> and <a title="View user profile." href="http://huffpostfund.org/users/eschwartz" jquery1280932414984="125">Emma Schwartz</a> Computers at a major Midwest hospital chain went awry on June 29 [after an 'upgrade' - ed.], posting some doctors’ orders to the wrong medical charts in a few cases and possibly putting patients in harm’s way. The digital records system “would switch to another patient record without the user directing it to do so,” said Stephen Shivinsky, vice-president for corporate communications at Trinity Health System. Trinity operates 46 hospitals, most in Michigan, Iowa and Ohio. [In other words, data entered by clinicians was going into the wrong charts. How many charts were involved? Does the hospital system even know, I wonder? - ed.] Less than two weeks later, an unrelated glitch caused Trinity to shut down its $400 million system for four hours at 10 hospitals in the network because electronic pharmacy orders weren’t being delivered to nurses for dispensing to patients, he said. ... Even absent any harm to patients, such incidents underscore possible risks faced by even large health organizations that have eagerly embraced new medical software to track patient records and treatment. As the Obama administration ramps up plans to create a digital medical file for every American by 2014 – at an anticipated tab to taxpayers of up to $27 billion – technology’s boosters tend to tout its potential benefits to patients and ability to slow runaway medical costs. Yet despite the high [actually, potentially catastrophic - ed.] political and financial [and clinical -ed.] stakes, the administration has established no national mandatory monitoring procedure for the new devices and software. That no process exists to report and track errors, pinpoint their causes and prevent them from recurring is largely the result of two decades of resistance by the technology industry, a review of government records and interviews by the Huffington Post Investigative Fund shows. The industry argues that even with flaws, digital systems are an improvement over current paper records.</blockquote> I began to document some of the problems and the resistance of what Washington Post reporter Robert O'Harrow Jr. in May 2009 called the "<a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/05/15/AR2009051503667.html?hpid=topnews">Healthcare IT lobby</a>" a decade ago in a website. That website, now hosted at Drexel University, is entitled "<a style="font-weight: bold;" href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties</a>." Few in government and industry were apparently listening, despite <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/content/documents/FINAL_Healthcare%20IT%20Failure_Oct_19_2006.ppt">ongoing worldwide interest in the topic</a> (PPT). Read the Huffington Post report in its entirety. It includes a slide-show timeline of the health IT industry's sidestepping of government oversight and safety concerns. As I am currently busy helping out my ill mother, I will offer more commentary later. However, one quote really stuck out. Is the Chairman of the Office of the National Coordinator for Health IT (ONC) <a href="http://healthit.hhs.gov/portal/server.pt?open=514&objID=15930&&PageID=15653&mode=2&in_hi_userid=10731&cached=true&utm_source=National+eHealth+Collaborative&utm_campaign=e1871fd68c-CONNECT_09_announcement_061209&utm_medium=email">Dr. David Blumentha</a>l lying, or simply misinformed? Judging by the quality of academic discourse these days, I'd hope the latter (an alarming situation in and of itself), but the former is also possible. He is quoted as stating: <blockquote> “We know that every study and every professional consensus process has concluded that electronic health systems strongly and materially improve patient safety. And we believe that in spreading electronic health records we are going to avoid many types of errors that currently plague the healthcare system,” Blumenthal said when unveiling new regulations in Washington on July 13.</blockquote> As at my July 14, 2010 post <a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html">Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records"</a> , however, I pointed out some examples that contradict this meme. This list is just for starters: (Hyperlinks to these and others can be found at my Medical Informatics teaching site <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=other">here</a> and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">here</a>:) <div class="PlainText" style="font-family:arial;"></div> <blockquote style="margin-right: 0px;font-family:arial;" dir="ltr"><div class="PlainText" style="font-family:arial;"></div><div class="PlainText" style="font-family:arial;">1. Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop by Bonnie Kaplan and Kimberly D. Harris-Salamone. From the May/June 2009 issue of JAMIA. 2. "E-Health Hazards: Provider Liability and Electronic Health Record Systems.” Hoffman and Podgurski’s followup paper on EHR medical and legal risks 3. Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors. Ross Koppel, PhD, et al, Journal of the American Medical Association, 2005;293:1197-1203 4. Electronic Health Record Use and the Quality of Ambulatory Care in the United States. Arch Intern Med. 2007;167:1400-1405. The authors examined electronic health records (EHR) use throughout the U.S. and the association of EHR use with 17 basic quality indicators. They concluded that “as implemented, EHRs were not associated with better quality ambulatory care.” 5. Pessimism, Computer Failure, and Information Systems Development in the Public Sector. (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand) 6. <a href="http://www.blogger.com/redir.aspx?C=cd79bb9ef239435c91597828510ff401&URL=http%3a%2f%2fiig.umit.at%2fefmi%2fbadinformatics.htm" target="_blank"></a>Bad Health Informatics Can Kill. his site contains summaries of a number of reported incidents in healthcare where IT was the cause or a significant factor. It comes from the Working Group for Assessment of Health Information Systems of the European Federation for Medical Informatics (EFMI). </div><div class="PlainText" style="font-family:arial;"></div><div class="PlainText">7. The U.S. National Research Council’s "Current Approaches to U.S. Health Care Information Technology are Insufficient." 8. The UK Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program. 9. Gateway reviews of the UK National Programme for IT from the Office of Government Commerce (OGC) (released under the UK’s Freedom of Information Act). 10. A report on the serious problems with the Department of Defense’s AHLTA system, Electronic Records System Unreliable, Difficult to Use, Service Officials Tell Congress. (This system, as I <a href="http://hcrenewal.blogspot.com/2010/07/4-billion-military-emr-ahlta-to-be-put.html">wrote here</a>, is slated for abandonment. I cannot imagine it was greatly improving outcomes). 11. A New York Times report “Little Benefit Seen, So Far, in Electronic Patient Records” on Jha’s research at the Harvard School of Public Health, that compared 3,000 hospitals at various stages in the adoption of computerized health records and found little difference in the cost and quality of care. 12. An American Journal of Medicine paper “Hospital Computing and the Costs and Quality of Care: A National Study” by Himmelstein and Woolhandler at Harvard Medical School, that also concluded “as currently implemented, hospital computing might [very] modestly improve process measures of quality but not administrative or overall costs." 13. A Milbank Quarterly article “Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method" by Greenhalgh, Potts, Wong, Bark and Swinglehurst at University College London. 14. Health Affairs, 29, no. 4 (2010): 639-646 Electronic Health Records’ Limited Successes Suggest More Targeted Uses, Catherine M. DesRoches et al. 15. NORCAL Mutual Insurance Company: "Electronic Health Records: Recognizing and Managing the Risks" (PDF <a href="http://www.norcalmutual.com/publications/claimsrx/oct_09.pdf">here</a>) </div></blockquote> My healthcare informatics graduate students are well aware of studies such as these. [Feb. 2011 addendum: see a much longer list at this link - <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">An Updated Reading List on Health IT</a> - ed.] Why isn't ONC Chairman Dr. Blumenthal? Perhaps equally as remarkable is this from <a href="http://www.trinity-health.org/index.htm">Trinity Health</a>, the healthcare system whose health IT crashed: <blockquote>We are not aware of any patient safety or quality of care issues caused by this event,” he said. </blockquote> Many of the "safety and quality" issues due to erroneous data in charts can come out weeks, months or even years later. The issue that the health IT cheerleaders seem to ignore is risk. Has the erroneous data been identified and corrected, I wonder? Probably not. According to the Huffington Post Investigative Fund article, they don't even know what caused the problem: <blockquote>... While doctors were concerned about the problems, ... [well, yes, I'd be quite frightened myself, especially considering who <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda">holds the liabilities</a> for health IT defects - ed.] ... Shivinsky said that most are happy with the system and would “never go back to paper.” [That sounds very nice. Is it true? - ed.] Meanwhile technicians are still trying to figure out the root cause. “We’ll get to the bottom of it and fix it,” he said.</blockquote> Eventually, I would hope, since the kludged "correction" I heard about is that clinicians can now only open one electronic patient chart at a time, potentially slowing and impairing their work. I've emailed Mr. Shrivinsky asking if they'd truly identified and remediated the problem yet. -- SS

Huffington Post Investigative Fund: FDA, Obama Digital Medical Records Team at Odds over Safety Oversight

(Note: also see my followup post " More on Huffington Post Investigative Fund: "FDA, Obama Digital Medical Records Team at Odds o...

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ETHICS TURNAROUND (sort of) by NIH INSTITUTE DIRECTOR

ETHICS TURNAROUND (sort of) by NIH INSTITUTE DIRECTOR What a difference a month makes. When I went on vacation in June the Director of NIMH, Thomas Insel, was stonewalling about his relationship with Charles Nemeroff. Insel wanted to put distance between himself and the poster boy for conflict of interest in academic medicine. The heat was on Insel because of revelations that he helped Nemeroff get a new position at Miami after his fall from grace at Emory. Insel also gave a green light for Nemeroff to reapply for NIMH grant funding, and he appointed Nemeroff to new research review committees. These actions were widely seen as efforts to help Nemeroff get back into circulation. It didn’t help that people called attention to past favors and lobbying by Nemeroff on behalf of Insel. Things continued to unravel, and on about June 29 Insel placed a <a href="http://www.nimh.nih.gov/about/director/2010/more-on-public-trust-and-conflict-of-interest.shtml">disclaimer</a> on his official blog. Insel here allowed that his earlier official statements “may be viewed as misleading.” This softening of Insel’s position was picked up June 29 by the <a href="http://chronicle.com/blogPost/NIH-Official-Softens-Denial-of/25174">Chronicle of Higher Education</a>. Not only was Insel’s disclaimer on his official weblog undated, it is mealy mouthed and it was widely criticized – <a href="http://hcrenewal.blogspot.com/2010/06/insel-admits-his-statements-may-be.html">here</a> and <a href="http://1boringoldman.com/index.php/2010/06/29/plausible-deniability-is-neither-a-medical-nor-scientific-standard/">here</a>, for instance – as further evidence of Insel’s disingenuousness. By July 7 we learned of further revisions to Insel’s position. In response to pressure from Senator Charles Grassley (R-Iowa), Insel <a href="http://freepdfhosting.com/2e0f575924.pdf">issued</a> a mea culpa in which he agreed that Nemeroff’s actions constituted “an egregious violation of NIH policy and University rules.” Insel also acknowledged that his willingness to help Nemeroff “may have created the appearance of favoritism. In retrospect, I regret that my actions… appear inappropriate for a Federal research official given my past association with Dr. Nemeroff.” This new statement also was raked over as further evidence of Insel’s dissembling – see <a href="http://www.pharmalot.com/2010/07/nimhs-insel-on-nemeroff-i-regret-my-actions/">here</a> and <a href="http://1boringoldman.com/index.php/2010/07/08/a-start/">here</a> and <a href="http://www.margaretsoltan.com/?p=24272">here</a>. Nowhere in Insel’s new self serving statements is there any apology for his ill advised appointment of Nemeroff to new Federal research review panels. This signals once again that Insel just doesn’t get it when it comes to his crony Nemeroff. It is not in the job description of an NIH Institute Director to taint research review panels with compromised and sanctioned scientists. Keep in mind that the appearance of malfeasance and impropriety most often occurs in the presence of malfeasance and impropriety. That is a standard Bayesian proposition that Insel seems not to grasp. In light of these developments, who can take seriously the work Dr. Insel says he has done to develop a new NIH initiative on ethics? The leadership of NIH tacitly acknowledged this problem when they recently <a href="http://blogs.nature.com/news/thegreatbeyond/2010/07/nih_extends_public_comment_per.html">extended</a> the period of comment on the new ethics proposals. This was done specifically to mend the regulatory hole that Insel and his crony Nemeroff walked through when Insel assured Pascal Goldschmidt at Miami that Nemeroff could go right ahead to apply for new NIMH funding. Left to his own initiative, Insel kept the hole wide open. His July 7 statement to Senator Grassley that "I do not condone the gap in our policy that allowed (Nemeroff) to avoid the penalty implemented by Emory by moving to another university…” rings hollow: actions speak louder than words, and Insel had many months in which he could have closed the gap before the present scandal surfaced. How much longer can NIH tolerate an ethical prevaricator as an Institute Director? Bernard Carroll

ETHICS TURNAROUND (sort of) by NIH INSTITUTE DIRECTOR

ETHICS TURNAROUND (sort of) by NIH INSTITUTE DIRECTOR What a difference a month makes. When I went on vacation in June the Director of NIMH,...

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Primary Care and the HC Renewal RUC-kus

Dr. Richard Baron, a Philadelphia internist who's unusual in that he's both a private-practice clinician and a well-published and -respected academic (he was recently ABIM <a href="http://www.abim.org/news/news/07_01_08-baron.aspx">Chair</a>), has been mixing it up in the pages of the New England Journal. To readers of this blog, it'll be useful armchair review: not just because the theme of generalist clinicians' decline should concern us, but because the blog itself comes into play! The topic of the day: why primary care doctors are in trouble. Why they're (my words, perhaps, not his) so prone to burnout. And why they're not replacing themselves. In his original April 26, 2010 <a href="http://www.nejm.org/doi/full/10.1056/NEJMon0910793">article</a>, Baron provided a "snapshot" from his own group practice to address the question, "What's keeping us so busy in primary care?" The piece repays reading if one wants the gory detail on just how tedious and time-consuming the "long tail" of primary care has become. Largely because of demands of third parties, primary care providers are mired in the briar patch of making money for other people instead of themselves, through myriad pre-authorizations, forms, renewals, and all the other parts of the glue that keeps health care going. We already knew a lot of this, at least tacitly. But what's wonderfully useful about Baron's above piece was that (a) he spelled it out crisply, (b) he did so with lots of numbers people could cite, and (c) did so in such a highly visible and prestigious venue. Now, in the latest number of the NEJM, Baron <a href="http://www.nejm.org/doi/full/10.1056/NEJMc1006151">mixes it up </a>with a couple of critics. First I have to wonder aloud, just how did the journal pick these particular two letters? (Or maybe the author did? Hard to believe they were the only two.) Typical--and this is something else it would be easy to measure in the Journal's correspondence pages--in that they both come from the ivory tower, not the trenches where Baron himself labors. The first letter, from a non-clinician at the Palo Alto Medical Foundation Research Institute, lamely posits the value of the electronic health record in identifying staffing needs for primary care. We happen to know not only that Baron's practice was a very early EHR adopter, but Dr. Baron himself has published eloquently on the sundry limitations of the EHR. In response, Baron gently reminds the Palo Alto ivory tower-dweller that very few practices can afford a registered nurse--even if the EHR could somehow magically discern the need for such a presence. A second writer chimes in from the equally rarefied reaches of the AMA's Relative Value Update Committee, or RUC, "appointed by the American Academy of Neurology." This writer avers that "the value assigned for evaluation and management is the same for all specialties," which clearly is the RUC's take on things but is fairly jaw-dropping to the rest of us. In response, Baron cites R. M. Poses, MD, moderator of the present blog, and a June 1, 2010 HCRenewal <a href="http://hcrenewal.blogspot.com/2010/06/ruc-off-new-england-journal-once-again.html">offering</a>--Poses has in fact given us many such offerings on the RUC--regarding the "significant structural and political issues" surrounding that body's untransparent deliberations. Usefully, Baron finally joins others stepping outside the visit-oriented physician payment schema, urging a paradigm shift in which he urges "systems that encourage and support services of high value ... rather than anchoring payment to visits." This exchange is telling in a number of ways. It shows up the lack of sync between the basic understandings on the part of health policy's chattering classes--those prone to publish and write letters to premiere journals--and of those actually doing the work of primary care. It also, I'll venture to say, shows up something more elusive about why this predicament is so difficult to fix. That is, we have, almost uniquely in this country, an imbalance--the imbalance in numbers, slowly evolving over the past century, between generalists and specialists--that's been around so long it's become part of the warp and woof. Something like ubiquitous guns or illicit cannabis, something very difficult to even think of getting beyond. We've written in this blog about the anechoic effect, how so much of what happens in health care (corrupt executives, nontransparent RUCs, etc. etc.) barely stirs a ripple in the public consciousness. Why that is we'll leave for another day, but it's been lately of interest to more and more folks. (For starters, just plug the term "anechoic" into the HCRenewal search box.) Add to this, now, what one might call the reverse Robin Hood effect. The result of such an effect is how the RUC and others--many others, in government as well as in industry--have managed to set in motion a specious reasoning process, a process that allows decision makers to justify robbing from the poor to give to the rich. Understandably, Baron does not go beyond the bland statement that such a process has "militated against appropriate updates for primary care services." But imagine what would happen if the RUC were suddenly, in what really boils down to a matter of power, dominated by people from primary care. Imagine what would then happen not only to reimbursements for cognitive services, but also to practitioners' morale, and to recruitment of medical students into primary care. History, both recent and not-so-recent, bears out such an assertion. When the UK increased the value of primary care a few years ago, in terms of pounds sterling, it had a salutary effect on non-fiduciary metrics such as recruitment. To quote Gomer Pyle, "surprise surprise surprise." Indeed, as the Economist <a href="http://www.economist.com/node/3966234">reported </a>five years ago (the preceding <a href="http://www.economist.com/node/3966234">link</a> may require subscription or library access), price signals worked wonders in making the primary care role more attractive. Further back, ironically, when procedural specialties had lower status than cognitive specialties--we're talking a couple hundred years ago, now--this controversy would have been simply incomprehensible to patients and clinicians alike. For those who'd respond, "but back in the wayback, we didn't have all the fabulous benefits of modern procedures," the simple response is, well, stuff and nonsense. The rising tide of science has raised all boats. Not a week goes by that the evidence base doesn't provide new reasons to assay minimally- or non-invasive technologies that are devolved to primary care physicians. No, underlying Baron's plea is the reverse Robin Hood effect and a simple matter of power. In fact, it's a phenomenon exceedingly well known to sociologists ever since <a href="http://www.garfield.library.upenn.edu/merton/matthew1.pdf">Robert Merton</a> in the 1960s. They call it the "<a href="http://en.wiktionary.org/wiki/Matthew_principle">Matthew Principle</a>," after the Gospel of St. Matthew. "To him who has, it shall be given." But in the US such a system, like that of sub-prime mortgages earlier in the present decade, has finally become so over-evolved it's threatening to topple over of its own weight. Thus, lobbyists are just now fighting the recess <a href="http://www.businessweek.com/news/2010-07-19/obama-sends-senate-berwick-nomination-for-medicare.html">appointment </a>of Dr. Don Berwick not because they think he doesn't understand how these processes work, but because they know that he does. Wish him, and Dr. Baron, luck.

Primary Care and the HC Renewal RUC-kus

Dr. Richard Baron, a Philadelphia internist who's unusual in that he's both a private-practice clinician and a well-published and -r...

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