healthy4u: huffington post investigative fund

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."(I'd written some preliminary comments at an earlier post entitled "Huf…

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04 Aug 2010

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 over Safety Oversight")The Huffington Post Investigative Fund has publis…

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04 Aug 2010

FDA Asks Hospitals to Report Safety Glitches in Digital Health Systems

A theme of my writings on this blog and on my <a href="http://www.tinyurl.com/healthITfailure">teaching site</a> for the past decade has been mismanagement of healthcare information technology by an industry and people who have been operating for many years far beyond their qualifications and competencies. Technology requiring the highest levels of biomedical-IT cross disciplinary expertise has most commonly been designed, managed, implemented, led and defended by amateurs [see note 1]. As a result of this mismanagement, the technology is not without its perils. The problem is that this industry suffers from constricted information flows for a number of reasons, and we do not know the magnitude of the perils. Even speculation is difficult since data is scarce. The technology remains experimental. After a commitment of tens of billions of economic recovery act funds to roll out this technology nationally, the Federal government has finally taken notice: <a href="http://huffpostfund.org/stories/2010/03/fda-asks-hospitals-report-safety-glitches-digital-health-systems"></a> <blockquote><a href="http://huffpostfund.org/stories/2010/03/fda-asks-hospitals-report-safety-glitches-digital-health-systems">FDA Asks Hospitals to Report Safety Glitches in Digital Health Systems</a> In Letter to 350 Health Centers, Agency Signals Growing Concern By Fred Schulte and Emma Schwartz Huffington Post Investigative Fund 3:24 pm | 11 Mar 2010 Concern over safety risks posed by health information technology has led the Food and Drug Administration to step up scrutiny of the products, including digital medical records systems on which the government plans to spend billions of dollars in coming years. The FDA last month asked a network of 350 hospitals it set up across the country to report data on potential hazards from a range of computer-assisted medical devices, according to an agency document obtained by the Huffington Post Investigative Fund.</blockquote> This should have occurred a decade ago, but better late than never (of course, this action will not help people already harmed by this technology such as <a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html">these</a> and <a href="http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_42.htm">these</a>). <blockquote>The FDA action comes as federal officials forge ahead with plans to use as much as $27 billion in economic stimulus money to replace paper patient records with digital ones. The Obama administration wants to create a digital health file for every American by 2014, saying the conversion will save money and improve the quality of health care.</blockquote> From an <a href="http://www.heartland.org/article/24761/Research_Commentary_Health_Information_Technology.html">analysis</a> that I concur with from the Heartland Institute: ... Proponents of this spending rely heavily on a short RAND Corporation analysis from 2005 that predicted $77 billion in annual savings and improved outcomes. RAND estimated “implementation would cost around $8 billion per year, assuming adoption by 90 percent of hospitals and doctors offices over 15 years.” It said, “The benefits can include dramatic efficiency savings, greatly increased safety, and health benefits.” Unfortunately, RAND assumed an error-free system that is quickly and enthusiastically adopted by virtually the entire health care system. That might happen, but it is an absolute best-case scenario. [See my aforementioned HIT teaching site on why a "best case scenario" is a near impossibility - ed.] Even then, instead of “dramatic savings,” the $77 billion hoped-for savings amounted to a mere 4.5 percent of total costs, placed at $1.7 trillion by RAND. Far more likely is that every penny of the $20 billion will be wasted on systems that don’t work and can never be implemented. [As per my <a href="http://online.wsj.com/article/SB123492035330205101.html">Feb. 18, 2009 Letter to the Editor</a> in the Wall Street Journal - ed.] That was the outcome of federal attempts to upgrade technology at the IRS, the FBI, and the air traffic control system. And these are all relatively simple enterprises involving single federal agencies. Health IT is vastly more complex and must include hundreds of thousands of private organizations that have invested in legacy systems that work reasonably well and are as varied as there are providers. Back to the Huffington Post Investigative Fund article: <blockquote>... Reports that hospitals send to the FDA are to be posted on an agency Web site. The FDA maintains it has the authority to regulate the technology, but has not taken steps to do so, leaving the industry largely to police itself. Reporting of problems is voluntary and most manufacturers have not done so.</blockquote> I think it accurate to say reporting is nearly nonexistent, yet I regularly hear stories from colleagues, former students, and others that make my hair stand on end. These people are afraid to speak out publicly, lest their careers be threatened by hospital sham peer review, vendor lawsuits, or other forms of retaliation against 'whistleblowers' (see an example <a href="http://hcrenewal.blogspot.com/2010/02/lawsuit-over-health-it-whistleblowing.html">here</a>). <blockquote>... In the letter sent to hospitals last month, Marilyn Flack, of the FDA’s Center for Devices and Radiological Health, said use of digital medical equipment “continues to grow and affect patient care and safety.” The FDA “is exploring problems….that may affect patient safety,” she wrote. The agency plans to collect reports using its Medical Product Surveillance Network, called MedSun. It is asking hospitals to note a wide range of problems involving electronic health records and other computerized systems for hospital laboratories, pharmacies and anesthesia and radiology devices, including hand-held ones.</blockquote> Here is the FDA letter. Click to enlarge: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhBrPpLZ8pDyADfYTXcfGCqUs7Hc9zKAdgJw1rKxAekOW8d9gLfx3TVF5iYQjuzGeIqYQlFyLV3ShPV8lLcu1U1CnlNI001Ued5mPCn5pQ7yqK44orMFPb9S7UvSLeU0mbmLuphMQ4pE0yU/s1600-h/fda1.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5447572877662219554" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhBrPpLZ8pDyADfYTXcfGCqUs7Hc9zKAdgJw1rKxAekOW8d9gLfx3TVF5iYQjuzGeIqYQlFyLV3ShPV8lLcu1U1CnlNI001Ued5mPCn5pQ7yqK44orMFPb9S7UvSLeU0mbmLuphMQ4pE0yU/s320/fda1.jpg" style="cursor: pointer; display: block; height: 225px; margin: 0px auto 10px; text-align: center; width: 194px;" /></a>FDA letter on health IT safety reporting, page 1 (click to enlarge) </div> <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh-xMO35Uk_kFsukCFUKScfk8neovITPgSsUrwoRXerdnx1pyxzgVT6Io5l8G-vQIM78BdDdgXaRebWyC559LUMUyKUOwyO8nT2W4p1uSlRKfb41aPfWZpBkiUl3uJKJ09HkS4MIV7UR1R-/s1600-h/fda2.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5447573067472695730" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh-xMO35Uk_kFsukCFUKScfk8neovITPgSsUrwoRXerdnx1pyxzgVT6Io5l8G-vQIM78BdDdgXaRebWyC559LUMUyKUOwyO8nT2W4p1uSlRKfb41aPfWZpBkiUl3uJKJ09HkS4MIV7UR1R-/s320/fda2.jpg" style="cursor: pointer; display: block; height: 219px; margin: 0px auto 10px; text-align: center; width: 189px;" /></a>FDA letter on health IT safety reporting, page 2 (click to enlarge)</div> I note that this letter is remarkable, a real breakthrough. It is also remarkable that this 'breakthrough' had to wait until 2010, not 1990 or 2000, and only after the government has pushed hard to spread this technology nationally without knowing the flip side. The expression "ready, fire, aim" comes to mind. Some of the 'glitches' were mentioned: <blockquote> ... She also cited an example of a software package used in a hospital emergency room in which lab tests “ordered for one patient returned the results for another.” In another case, a hospital in the MedSun network reported an operating room software product that often “locked up” during surgery, without alerting anyone that “data entry had ceased.” According to the FDA letter: “At the end of the surgical procedure, surgical procedure notes were incomplete—compromising the accuracy of the data as nurses had to manually re-enter from memory many of the surgical notes.” In a third case cited by Flack, a radiology workstation became “extremely slow, delaying procedures and causing X-ray techs to subject patients to repeat X-rays.” The cause was determined to be a software glitch that happened when too many characters were entered in.</blockquote> These 'glitches' largely come from poor design, engineering, implementation and support and don't even include <a href="http://www.tinyurl.com/hostileuserexper">mission hostile user experiences</a> from software that is 'working correctly.' <blockquote>... Arthur Bartosch, director of Biomedical Engineering Services at Westchester Medical Center in New York, agreed [that in the past, cinical engineering staff would not have been involved in health IT safety reporting]. He said he planned to circulate the FDA’s alert to the hospital’s chief medical information officer and they would “probably” create a task force to figure out how to document any problems.</blockquote> It is pathognomonic of IT irrational exuberance and special accommodation given to this technology (greased by ignorance, money, politics and other pathologies among healthcare and hospital leadership juntas) that such 'task forces' are not as common as health IT itself. <blockquote>... “The fundamental problem we have here is we’re dealing with an industry that really isn’t used to a transparent reporting of problems,” [Paul Egerman, co-chair of a government panel looking at the safety of health information technology] said. [Isn't used to transparent reporting? I would have said "hostile to the extreme" regarding that kind of transparency - ed.] Egerman, whose advisory panel expects to make its findings public in April, said government officials have a long way to go in fully understanding the potential hazards of adopting the new technology.</blockquote> I noted a "hit" from EOP.gov (Executive Office of the President) on my <a href="http://www.tinyurl.com/healthITfailure">ten year old HIT teaching site</a> just yesterday. I believe it is the first. Welcome to Medical Informatics 101, Mr. President. <blockquote>“Are there much more serious problems that we would know about if we had the data?,” he said. “These are all reasonable questions to ask.”</blockquote> I injured my career in the past for asking just those questions, having been badgered to stop asking them essentially to the point of constructive discharge in my former CMIO role. Let's see if the change of culture is real, or just talk. It's not that safety reporting and transparency are anything new or special. From the Joint Commission in their August 2009 <a href="http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_43.htm">Sentinel Events Alert #43</a>: <blockquote>Existing Joint Commission requirements: The Leadership chapter in the standards manual addresses leadership and safety, specifically relating to the organization's governing body, the chief executive and senior managers, and medical and clinical staff leaders. The standards specifically require that these three leadership groups create a culture of safety (11) by creating an atmosphere of trust and fairness that encourages reporting of risks and adverse events, by allocating the resources necessary to support safety, by discussing and reporting safety issues and indicators, and by developing plans to assure and improve safety performance, especially in relation to high-risk or problem-prone processes. Other issues covered in the standards are: the implementation of important systems within the organization that support safety; the organization's safety program for reporting adverse events and near misses; and the design or modification of processes to support safety. </blockquote>And: <blockquote> Suggested Actions (item #2): Institute an organization-wide policy of transparency that sheds light on all adverse events and patient safety issues within the organization, thereby creating an environment where it is safe for everyone to talk about real and potential organizational vulnerabilities and to support each other in an effort to report vulnerabilities and failures without fear of reprisal. (8,9)</blockquote> Finally, considering that the average salary offered to a hospital "Director of Informatics" is a penurious $90-120K per annum with respect to the true expertise required for top roles (don't just take my word for it, take <a href="http://hcrenewal.blogspot.com/2009/12/onc-defines-taxonomy-of-health-it.html">ONC's</a>), and that <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=leadership">'lowball hiring'</a> in terms of expertise is pervasive, I predict that if robust error reporting takes place, the next few years in HIT will be a wild ride indeed. -- SS [1] I use the term "amateur" in the same sense that I am a <a href="http://www.arrl.org/" style="font-style: italic;">telecommunications amateur</a>, not a professional. Even though I hold the highest license class possible, the Extra, I would not even dream of leading a large telecom project.

FDA Asks Hospitals to Report Safety Glitches in Digital Health Systems

A theme of my writings on this blog and on my teaching site for the past decade has been mismanagement of healthcare information technology by an industry and people who have been operating for many y…

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11 Mar 2010

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