We're Sorry ... Our New EMR May Screw Up Your Care, But Don't Worry ... Patient Safety Has Not Been Compromised

A sign seen at a hospital system recently (name redacted):<br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiFv5Vc8MnAwjhlsEA5uP2zO7n0IiSujhj7kGyn2C6ygwzf714UqSrPgQh4-vNNnHBrY1K4NCiRSY3sAOTaeEcP5UL8R0a5dQRr0ILudU-oWkOnTf9uegkc__nrKq6XV-gyuHLGueztsCJC/s1600/we're+sorry+2.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="311" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiFv5Vc8MnAwjhlsEA5uP2zO7n0IiSujhj7kGyn2C6ygwzf714UqSrPgQh4-vNNnHBrY1K4NCiRSY3sAOTaeEcP5UL8R0a5dQRr0ILudU-oWkOnTf9uegkc__nrKq6XV-gyuHLGueztsCJC/s1600/we're+sorry+2.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">We're Sorry for any "Delays" as we start using our new EMR system ... But as a patient, you'll notice many benefits.   As to risks, nothing to see here ... move along.   <b>(Click to enlarge)</b></td><td class="tr-caption" style="text-align: center;"><br /></td><td class="tr-caption" style="text-align: center;"><br /></td><td class="tr-caption" style="text-align: center;"><br /></td><td class="tr-caption" style="text-align: center;"><br /></td></tr></tbody></table><br />FirstNet is an EMR system for <b>Emergency Departments. </b><br /><br />What's missing here is this:<br /><br /><ul><li>While "<a href="http://hcrenewal.blogspot.com/search/label/glitch">glitches</a>" that can harm you can happen anytime with these systems, at startup time <a href="http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html">disruptions and malfunctions</a> that could cause injury or death (as reported by <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">FDA</a>, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">U.S. Institute of Medicine</a>, ECRI Institute per their <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">Deep Dive study of health IT risk</a> and others) are most common;</li></ul><ul><li>Potentially deadly EHR startup "issues" can number in the <b>many thousands</b> (<b><a href="http://hcrenewal.blogspot.com/2013/11/weve-resolved-6036-issues-and-have-3517.html">as at this link</a></b>); </li></ul><ul><li>If you don't want to subject yourself to these delays and/or glitches, you are free to select another hospital for your care. </li></ul><ul><li>(If you are injured or die as a result of the "Delays", then ... we're <i>Extra-Special With Sugar On Top </i>Sorry?)</li></ul><br />In other words, this glib, nonchalant signage is incomplete, and misleading on its face.<br /><br />While I understand its purpose, it ignores patient rights to informed consent and knowledge of a potentially unsafe environment for care, which hospitals have to prevent as an ethical and legal obligation.<br /><br />Of course, "please feel free to ask your caregiver if you have any questions" ... who may in fact be limited by contract or edict to only use <b>"<i>Words That Work</i>"</b> to further soothe unsuspecting patients (<b><a href="http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html">as at this link</a></b>)<b>.</b><br /><br />-- SS

We're Sorry ... Our New EMR May Screw Up Your Care, But Don't Worry ... Patient Safety Has Not Been Compromised

A sign seen at a hospital system recently (name redacted): We're Sorry for any "Delays" as we start using our new EMR system ....

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The CareFusion/ Dr Denham/ NQF /Leapfrog Goup Case that Would Not Go Away - NQF CEO Outed as Member of Premier Inc Board

<br />The story of the CareFusion/ Dr Denham/ NQF/ Leapfrog Group case refuses to go away, even if it still has not created any echoes in the mainstream media or the medical and health care literature.  Now it appears that the NQF has an even bigger conflict of interest problem than previously reported.  <br /><br /><b>Background</b><br /><br />As of our <a href="http://hcrenewal.blogspot.com/2014/02/the-implications-of-carefusion-dr.html">last post</a> on 5 February, 2014, the background was-<br />-  The case became public with an apparently routine legal settlement between CareFusion and the US Department of Justice<br /> -  The CareFusion settlement for $40.1 million was made in response to allegations that kickbacks were made to promote <a href="http://www.carefusion.com/medical-products/carefusion-brands/chloraprep/">ChloraPrep</a>, a solution meant for preoperative and other health care skin cleaning<br />-  The Department of Justice <a href="http://www.justice.gov/opa/pr/2014/January/14-civ-021.html">news release</a> also alleged that payments were made to a corporation called Health Care Concepts to conceal kickbacks made to its owner, Dr Charles Denham<br />-  The implication was that Dr Denham was supposed to influence a standard writing committee run by the National Quality Forum, a well known organization that promotes quality improvement, issues authoritative practice standards, a form of clinical practice guidelines, and has contracts with the US government for quality of care activities<br />-  The draft of the standard to prevent surgical site infection written by the committee allegedly included the use of ChloraPrep, although mention of that specific medication was removed in a revision<br />-  The Department of Justice alleged that the standard was based on a journal article sponsored by Cardinal Health, from which CareFusion split, and which may have been manipulated by its sponsor<br />-  NQF leaders asserted that after hearing of the case from the DOJ, the organization severed ties with Dr Denham and the non-profit organization he runs,  established a policy not to accept money from funding organizations whose leaders are on its committees, reviewed all the standards set by the committee of which Dr Denham was co-chair, and twice revised its conflict of interest policy.<br />- Despite these efforts by the NQF to remove excess influence by Dr Denham, a specific recommendation to use ChloraPrep, specified by formula but not by name, did appear in another NQF standard, one for preventing central line infections; the NQF logo apparently appeared on at least one educational event run by Dr Denham that advocated the use of ChloraPrep; and CareFusion cited NQF support in at least one promotional brochure<br />-  In retrospect, people who worked with Dr Denham on various health care quality and patient safety projects acknowledged they should have realized something fishy was going on.<br />-  Senator Charles Grassley is now investigating<br /><br /><b>The Conflicts of the NQF CEO</b><br /><br />In our <a href="http://hcrenewal.blogspot.com/2014/01/our-man-in-nqf-carefusion-settles.html">first post</a> about the case, I noted that at the time that Dr Denham was a committee member, the NQF seemed to have a relatively weak policy on conflicts of interest, although  <a href="http://hcrenewal.blogspot.com/2014/01/putting-in-ski-lifts-national-quality.html">this post</a> noted it was later strengthened somewhat.  I also commented that the organization seemed accommodating of conflicts of interest affecting its board of directors, and to have institutional conflicts of interest in that it accepted funding from health care corporations which might have interests in NQF quality standards being written in their favor.  <br /><br />So maybe it should not be too great a surprise that the latest twist in this case is the revelation that the new CEO of NQF has her own quite significant conflicts of interest.  Last week, ProPublica published a <a href="http://www.propublica.org/article/payments-to-ceo-raise-new-conflicts-at-top-health-quality-group">story</a> about the conflicts of interest of the new CEO of the NQF.  The basics were:<br /><br /><blockquote class="tr_bq"><div class="article">The top executive at the country’s pre-eminent health care quality organization is <i>being paid hundreds of thousands of dollars by two large medical companies that have a stake in the group’s work.</i><br /><br /><i>The payments to Dr. Christine Cassel raise new conflict-of-interest concerns at the National Quality Forum,</i> which endorses benchmarks that Medicare uses to compensate hospitals based on performance.<br /><br />As <a href="http://www.propublica.org/article/hidden-financial-ties-rattle-top-health-quality-group" target="_blank">ProPublica recently reported</a>, the Quality Forum is reviewing its conflict-of-interest policies after being stung by allegations that the former co-chair of one of its endorsement committees had accepted kickbacks to help a drugmaker win favorable treatment.<br /><br /><i>Cassel received about <b>$235,000 </b>in compensation and stock last year as a <a href="https://www.premierinc.com/wps/portal/premierinc/public/aboutpremier/leadership/biographies/christine-cassel" target="_blank">board member for Premier Inc.</a>, a North Carolina company that says it provides group purchasing and performance improvement consulting for an <a href="https://www.documentcloud.org/documents/1013194-premier-comments-august2013.html#document/p1/a143354" target="_blank">alliance of 2,900 hospitals</a> and thousands of nursing facilities and other providers. </i><br /><br /><i>Cassel also was paid <b>$189,000</b> as a board member for the Kaiser Foundation Health Plans and Hospitals in 2012, </i>Quality Forum officials confirmed to ProPublica. Kaiser’s tax forms are not available for 2013, but they show that in 2010 and 2011 Cassel received a total of $357,125.</div><div class="article"><br />Cassel, who declined to be interviewed, took over as chief executive officer last summer after a decade as president and CEO of the American Board of Internal Medicine. </div></blockquote><div class="article"></div><div class="article"><br />Not unexpectedly, the official position of the NQF was nothing to see here, just move along.</div><div class="article"></div><div class="article"><br /><blockquote class="tr_bq"><a href="http://www.qualityforum.org/About_NQF/Board/Board_of_Directors_Roster.aspx" target="_blank">The group's chairwoman</a>, Helen Darling, said in an email that <i>the board was 'fully aware' of Cassel’s outside compensation</i> when she was hired in December 2012. Darling, president of the National Business Group on Health, initially agreed to an interview but did not respond to follow-up contacts.<br /><br />Spokeswoman Ann Greiner said the board got a legal opinion and discussed it in depth before agreeing that <i>Cassel could recuse herself 'where her outside board service would be construed as an actual or perceived conflict of interest.'</i> So far that hasn’t happened, Greiner said.</blockquote></div><br />Note that those defending NQF saw no reason to explain why it had not previously disclosed Dr Cassel's other positions or how the conflicts would be managed.  Perhaps a board that includes executives of large health corporations, of a financial firm with large health care interests, and of a trade associations for large health care corporations would not see a problem with having a CEO who is simultaneously on the boards of a for-profit hospital group purchasing organization and a very large, albeit non-profit health care system. <br /><br />Others were much more skeptical and critical.  <br /><br /><blockquote class="tr_bq">Two ethics experts interviewed by ProPublica said Cassel’s relationships with Kaiser and Premier <i>present obvious conflicts given the Quality Forum’s broad involvement in health care.</i><br /><br />The Quality Forum maintains a clearinghouse of more than 700 quality measures — covering everything from tracking hospital readmissions to setting information technology standards — that are established by expert committees and widely adopted by U.S. hospitals and other providers. </blockquote><br />The ethics experts said they were uncertain how Cassel could recuse herself to anything related to Kaiser and Premier and still do her job.<br /><br /><blockquote class="tr_bq"><i>'Would that mean every time somebody said the word ‘hospital’ she would have to say, ‘I can’t be in this conversation?’'</i> said <a href="http://www.instituteforhealthpolicy.org/core_faculty/Campbell" target="_blank">Eric Campbell</a>, a Harvard School of Medicine professor who has published extensively on conflicts of interest.<br /><br />'Conflict of interest is as much an appearance as it is an effect,' added <a href="http://www.tufts.edu/%7Eskrimsky/bio.htm" target="_blank">Sheldon Krimsky</a>, a medical ethics expert at Tufts University. He called Cassel’s conflicts <i>'absolutely egregious'</i><br /><br />Campbell and Krimsky said the cleanest way to eliminate potential conflicts would be for Cassel to resign from the outside boards.</blockquote><br />The plot thickens because of the amount of influence wielded by the NQF,<br /><br /><blockquote class="tr_bq"> In 2009, <i>Medicare awarded a <a href="https://www.fbo.gov/index?s=opportunity&mode=form&tab=core&id=bf9a9aa4529a19bab87c7c2c09ce2c9f&_cview=0" target="_blank">$40 million contract to the Quality Forum</a> to recommend <a href="https://www.fbo.gov/index?s=opportunity&mode=form&tab=core&id=f5a7e6b022cc2e926efa8dccf90ec220&_cview=0" target="_blank">measures</a>it could adopt. President Obama’s health care reform law accelerated the move to pay-for-performance</i>. Medicare already <a href="http://www.kaiserhealthnews.org/Stories/2013/November/14/value-based-purchasing-medicare.aspx" target="_blank">has begun penalizing and rewarding</a> hospitals based on readmission rates, mortality and patient satisfaction measures. By 2017, it’s expected that <a href="http://www.qualityforum.org/what_we_do.aspx" target="_blank">9 percent of Medicare payments</a> will be based on performance.</blockquote><br />Having some leverage on that influence would seem to be particularly important to Premier Inc, the now publicly held for-profit group purchasing organization on whose board Dr Cassel sits,<br /><br /><blockquote class="tr_bq"> Premier reported revenues of $869 million in the fiscal year ending last June. It spent more than $1 million on lobbying in 2013, according to OpenSecrets.org. In August and November, <i>the company urged members of Congress to instruct Medicare to <a href="https://www.documentcloud.org/documents/1013194-premier-comments-august2013.html#document/p9/a143149" target="_blank">run any quality measures through the Quality Forum</a>.</i><br /><br /><i>Premier <a href="https://www.documentcloud.org/documents/1010105-premier-5-31-13-sec-form-s-1-registration.html#document/p173/a143373" target="_blank">featured Cassel’s status</a> as a board member and future top executive of the Quality Forum in documents last May describing its initial public stock offering.</i> In September<i> <a href="https://www.documentcloud.org/documents/1010111-premier-9-27-13-cassel-acquired-3-704-shares.html#document/p1/a143369" target="_blank">Cassel acquired 3,704 shares of Premier</a> stock that were then worth about <b>$100,000.</b></i><br /><br />The company’s business involves group purchasing and <i>a consulting arm that uses data analysis to help providers perform better on various quality metrics. In October, a measure sponsored by Premier to track hospital care by the average length of stay <a href="https://www.documentcloud.org/documents/1015398-nqf-ave-los-oct-2013.html" target="_blank">was up for renewal by the Quality Forum</a>.</i></blockquote><br />Of course, a Premier Inc spokesperson denied that could be a problem,<br /><br /><blockquote class="tr_bq">[Spokesperson Blair] Childs said Cassel’s role on the Premier board doesn’t pose any conflict of interest, and that <i>her relationship with Premier was vetted carefully by the Quality Forum’s board</i>. Cassel was a good addition to the Premier board because of her commitment to improved care and lower costs, he said.</blockquote>However, I submit that the conflict here is particularly acute because Dr Cassel is not merely a part time consultant or adviser to Premier Inc.  She is on the board of directors.  In 2006 we first <a href="http://hcrenewal.blogspot.com/2006/03/new-species-of-conflict-of-interest-in.html">discussed</a> a newly discovered species of conflict of interest in health care, in which leaders of medical or health care organizations were simultaneously serving on boards of directors of health care corporations.  We posited these conflicts would be particularly important because being on the board of directors entails not just a financial incentive.  It ostensibly requires board members to "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. <a href="http://www.amazon.com/Corporate-Governance-Robert-G-Monks/dp/1405116986"><i>Corporate Governance</i></a>, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.]  Of course, after the global financial collapse of 2008 made us sadder and a little wiser, we realized that many board members actually seem to have unyielding loyalty to their cronies among top management.  However, in any case, the stated or actual interests of a member of the board of a health care corporation, like a for-profit hospital purchasing organization, could be very different and at odds with the mission of an academic medical institution or a non-profit ostensibly dedicated to improving health care quality.  <br /><br />However, in my humble opinion, the issue here goes even beyond a blatant and undisclosed conflict of interest.  That a top steward of a big for-profit health care corporation could simultaneously be the top leader of an influential non-profit health care quality improvement organization suggests that increasingly US health care is run by an insular group of insiders whose influence gets ever larger because of their collective power, not necessarily because of their dedication or ability to improving health care.  As ProPublica put it,<br /><blockquote class="tr_bq">Rosemary Gibson, an author and senior adviser to The Hastings Center, a research group dedicated to bioethics in the public interest, said she wasn’t surprised at Cassel’s outside compensation. <i>So much money permeates decision-making in Washington, she said, that participants have become oblivious</i>.<br /><br />'The insiders don’t see it,' Gibson said. '<i>It’s like a fish in water.</i>'</blockquote><b>Additional Questions </b><br /><br /><br />Finally, the forced disclosure of Dr Cassel's conflicts of interest raise some additional questions.  <br /><br /><u>Did Dr Cassel Have an Equally Severe Conflict as CEO of the ABIM? </u><br /><br />Dr Cassel was previously the CEO of the American Board of Internal Medicine (ABIM).  This non-profit organization also has a very substantial influence on health care.  Physicians must pass its examinations to become certified as internal medicine specialists or sub-specialists such as cardiologists, gastroenterologists , etc.  Recently certified physicians, and soon all certified physicians will have to participate in ABIM sanctioned "maintenance of certification" activities or risk being flagged as not adequately keeping with the board's concept of medical progress.<br /><br />Thus the content of the ABIM examinations and sponsored activities can influence physicians' thinking and decision making.  How the ABIM under Dr Cassel's leadership dealt with conflicts of interest affecting those who write examinations, provide content, and lead the organization is unclear.<br /><br />Furthermore, it seems possible that Dr Cassel had a conflict of interest generated by her work for Premier Inc while she was still CEO of ABIM.  However, before Premier Inc made its initial public offering, information about its management and governance was scarce.  Whether Dr Cassel was on the board of a precursor to the publicly traded Premier Inc is not easy to ascertain.  Maybe the current ABIM leadership needs to consider whether Dr Cassel had a conflict involving Premier Inc or its precursor while she was CEO of ABIM, and how that conflict could have affected the direction of ABIM at the time.  <br /><br /><u>How Would Dr Cassel Respond to Criticisms of Premier Inc and How Would that Reflect on the ABIM and the NQF?</u><br /><br />Premier Inc is a hospital group purchasing organizations (GPOs).  GPOs, particularly including Premier Inc, have been criticized for anti-competitive practices that distort the market in health care drugs and devices, for accepting the ethical equivalent of kickbacks, and particularly for generating drug shortages.  For example, an <a href="http://articles.baltimoresun.com/2014-02-07/news/bs-ed-drug-shortage-20140209_1_shortages-supply-chain-drugs">opinion piece</a> in the Baltimore Sun claimed,<br /><br /><blockquote class="tr_bq"> The main reason is that most of these drugs are purchased through a handful of supply chain middlemen called hospital group purchasing organizations, or GPOs, <i>whose anti competitive practices and self-dealing have been documented in Senate antitrust hearings, media reports, government investigations and lawsuits.</i> These buyers' monopolies purchase upward of $300 billion in drugs, devices and supplies annually for about 5,000 private acute care hospitals, including virtually every one in Maryland. Five giants account for roughly 90 percent of all such purchases. [Apparently including Premier Inc - Ed]<br /><br />Under <i>a 'pay-to-play' arrangement</i>, vendors compete not on the basis of who can supply the best product at the best price but on who can pay the biggest fees to these cartels. In return, they receive exclusive contracts. <i>This artificially constrained supply chain is why many drug manufacturers have fled the marketplace, </i>leaving just one or two to produce many drugs. In turn, hospitals receive incentives based on their compliance with contracts the GPOs award to favored suppliers.<br /><br />In 1987, Congress enacted the Medicare anti-kickback 'safe harbor,' which exempted GPOs from criminal penalties for accepting payments from suppliers —<i> payments that in virtually every other industry would be considered unlawful kickbacks.</i></blockquote><br />The GPOs trade organization vigorously contested this argument, of course.<br /><br />But the awkward fact is that Dr Cassel, as a board member of Premier Inc, can be seen as a steward of that corporation, and hence responsible for the its overall direction.  Thus, Dr Cassel could easily find herself in the uncomfortable situation of having to defend and justify questionable behavior by Premier Inc while simultaneously wearing the hat of CEO of NQF.  How that would play out is not obvious.<br /><br /><b>Summary</b><br /><br />So now it appears that the problems with conflicts of interest at the NQF affect not only its standard setting committees, board of trustees, and organizational funding.  They also affect its CEO. <br /><br />Dr Joe Collier said, "people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult."  [Collier J. The price of independence. Br Med J 2006; 332: 1447-9. Link <a href="http://bmj.bmjjournals.com/cgi/content/full/332/7555/1447">here</a>.]  To reduce further unclear thinking and its consequences, we again urge that academic medical institutions, and non-profit organizations dedicated to improving patient care and public health forthwith begin real reductions of conflicts of interest affecting all those who make clinical or policy decisions.    <br /><br />We <a href="http://hcrenewal.blogspot.com/2014/01/putting-in-ski-lifts-national-quality.html">previously suggested</a>:that NQF leaders might also consider:<br />-  further strengthening their conflict of interest policy for standard setting committees, particularly by minimizing the number of committee members with conflicts, and banning individuals with conflicts from chairing committees, as per the <a href="http://www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust.aspx">IOM report on standards for trustworthy clinical practice guideline development</a><br />-  increasing transparency about conflicts of interest, particularly by making disclosures for all projects available without complex web searching<br />-  decreasing institutional conflicts of interest by refusing funding from health care corporations whose revenues might be affected by the content of standards and guidelines, and reducing conflicts affecting NQF board members and executives<br /><br />I would now add that in my humble opinion, the NQF ought to immediately fully disclose any other conflicts that might exist affecting its committees, staff, board of trustees, or funding, and then begin a progressive but ultimately complete phase out of all significant conflicts affecting these areas.   <br /><br />Roy M. Poses MD for Health Care Renewal <br /><br />

The CareFusion/ Dr Denham/ NQF /Leapfrog Goup Case that Would Not Go Away - NQF CEO Outed as Member of Premier Inc Board

The story of the CareFusion/ Dr Denham/ NQF/ Leapfrog Group case refuses to go away, even if it still has not created any echoes in the main...

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Computer woes hit Banner hospital system: Another large EHR outage ... but patient safety was not compromised

Here is yet another story in the genre of "EHRs go out, but patient care has not been compromised." (See query link at <a href="http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised">http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised</a>; there are more than 20 posts there now):<br /><br /><blockquote class="tr_bq"><b>Computer woes hit Banner hospital system</b><br />Ken Alltucker, The Arizona Republic 12:30 a.m. EST February 20, 2014<br /><a href="http://www.usatoday.com/story/news/nation/2014/02/19/computer-woes-slam-banner-hospital-system/5630829/">http://www.usatoday.com/story/news/nation/2014/02/19/computer-woes-slam-banner-hospital-system/5630829/</a><br /><br />The Phoenix-based health system used backup paper records to help provide patient care.<br /><br />PHOENIX -- Banner Health grappled with a widespread computer outage Wednesday as hospitals and doctors resorted to backup paper systems to provide care for patients.<br /><br />The Phoenix-based health system did not immediately know what triggered the computer troubles that started just before 10 a.m. PST. An official described the computer troubles as a rolling outage of computer systems at hospitals and other health care facilities in Phoenix, Colorado and Nevada.</blockquote><br />"Not knowing" means that you are not in control of your life-critical information systems; rather, they are in control of you.<br /><br /><blockquote class="tr_bq">By <b>late Wednesday</b>, a spokesman said, technicians had identified the problem and were fixing it. They expect to investigate the root cause of the problem Thursday.</blockquote><br />It took from 10 AM to "late Wednesday" to identify a problem causing a mass outage.  That should give anyone pause about dependency on fragile information systems in the hands of hospital IT departments (whose personnel undergo an ocean's less qualification-vetting than the medical personnel who depend on their work product) for one's medical care.<br /><blockquote class="tr_bq"><br />Banner Health, the Phoenix area's largest health care system, activated "downtime procedures" that included using paper-based systems to track medications and other care provided to patients, officials said.<br /><br />Banner's emergency departments still provided care to patients and accepted new patients.<br /><br />Some non-emergency surgeries and appointments were delayed because of the computer troubles.<br /><br />"There have been some delays and inconveniences, <b>but we are still providing care,</b>" said Bill Byron, Banner Health's senior vice president of public relations.</blockquote><br />In other words, what they are saying is "we really don't need these systems, that cost hundreds of millions of dollars, to provide care with the same degree of safety as with our 'downtime procedures' (a.k.a. paper)" ... and that patient safety was not compromised by this mass outage.<br /><br /><blockquote class="tr_bq">Banner Health, which operates 24 hospitals and several primary-care offices and outpatient centers in more than a half-dozen states, was working to "reboot" the computer systems Wednesday evening through a series of sequential fixes, Byron said.<br /><br />In the meantime, <b>Banner officials were able to retrieve computer-based records that detailed patients' medical histories</b>, including any medications, laboratory results and procedures that were previously performed.</blockquote><br />Officials?  What about line clinicians?  And when did this capability start if the systems needed to be "rebooted?"<br /><br /><blockquote class="tr_bq">Nurses and doctors shifted to writing on paper records after the computer systems experienced trouble Wednesday morning.<br /><br />Information from those paper charts will be keyed into the patients' computer-based health records after the problem is fixed.</blockquote><br />Sure, and nothing will be lost that could adversely affect patients in the future....<br /><br /><blockquote class="tr_bq">Banner Health has been among the most advanced health systems in the nation in converting to computer-based health records.<br /><br />Banner Estrella Medical Center was among the first hospitals to open as an "all-digital" facility in the past decade. Banner's other hospitals have largely completed the final stages of installing computerized record-keeping in areas such as physician order and entry and electronic documentation.</blockquote><br />If they are the most advanced, what does this event say about those less advanced?<br /><br /><blockquote class="tr_bq">Arizona law does not require hospitals to notify state health regulators in the event of such a widespread outage.</blockquote><br />Health IT, as usual, enjoys widespread and extraordinary regulatory accommodation.<br /><br /><blockquote class="tr_bq">However, some hospitals have internal policies requiring that they notify health accrediting organizations or federal regulatory agencies, such as the Centers for Medicare and Medicaid Services, an Arizona Department of Health Services spokeswoman said.</blockquote><br />And how many do?  Not many, I predict.<br /><br />-- SS

Computer woes hit Banner hospital system: Another large EHR outage ... but patient safety was not compromised

Here is yet another story in the genre of "EHRs go out, but patient care has not been compromised." (See query link at http://hcre...

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To Die in Texas - Dr Mahmood's Apparently Fatal Stealth Hospital System Collapses Nearly Anechoically

I would bet that most people in the US still think our health care system is highly regulated.  Some may thus conclude that the system is basically safe, because, for example, drugs have to be proven safe and effective to be approved by the government, and hospitals must be licensed and run by competent people who are thoroughly vetted.  Of course, some people still think that the US has, or had until recently, the best health care system in the world (look <a href="http://www.nbcnews.com/health/health-care/best-health-care-system-really-john-boehner-f2D11598594">here</a>).<br /><br />Furthermore, the view that less regulation is always better is no quite popular in the US and elsewhere.  For example, after the chemical spill threatened water supplies in the capitol of West Virginia, the Dallas News <a href="http://www.dallasnews.com/news/west-explosion/headlines/20131221-despite-crises-from-salmonella-outbreak-to-west-blast-rick-perry-s-pushed-freer-rein-for-business.ece">reviewed</a> Texas Governor Rick Perry's consistent attacks on government regulation.    <br /><br /><blockquote class="tr_bq">'American business in general, and American agriculture specifically, have <i>had enough of bureaucracy at both the federal and state levels,</i> but especially bureaucracy out of Washington,' Perry said at a congressional hearing. 'The men and women who feed and clothe this nation are suffocating under the weight of mounting federal regulations.'<br /><br />That was back in 1993, when Perry was Texas’ agriculture commissioner. Now Texas’ longest-serving governor, Perry has remained <i>steadfast in his opposition to government regulations. </i></blockquote><br />Some who take such a neoliberal stance may say the health care system is over-regulated, and thus is inefficient and not innovative, leading to our high costs and poor access.<br /><br />However, an amazing case out of Governor Perry's Texas that was made public last year, and I regret I just heard about recently, suggests how little health care may be regulated, and how unregulated health care, whether or not it is efficient, may be deadly. <br /><br />As <a href="http://www.dallasnews.com/investigations/patient-safety/headlines/20130713-patients-died-amid-federal-state-regulatory-inaction.ece">reported</a> in the Dallas News, July, 2013, in the last few years there seems to have been an epidemic of quality problems in a number of seemingly unrelated small rural Texas hospitals.  The report focused first on one hospital, <br /><br /><b>Renaissance Hospital Terrell</b><br /><br />After for-profit hospital corporation Renaissance Healthcare declared bankruptcy in 2008 (look <a href="http://www.bizjournals.com/houston/stories/2008/09/08/story6.html">here</a>), it sold its hospital in Terrell, Texas to RH Terrell Management LLC owned by one Dr Tariq Mahmood.  Almost immediately, however, there was trouble.  First Edwina Henry, the quality director, spied a doctor making questionable entries in patients' charts:<br /><br /><blockquote class="tr_bq">from her office, she had a clear view of doctors’ foot traffic through the medical records department.<br /><br />When she saw [Dr Tariq] Mahmood jotting in patient charts, she <i>knew he wasn’t seeing patients. Mahmood himself had not been credentialed to treat patients</i> — a process in which management vets backgrounds and competencies of doctors. Part of Henry’s job was tracking such evaluations. She also knew it was a breach of privacy laws to review patients’ medical records.<br /><br />'I immediately questioned some of the clerks and [insurance billing] coders,' she said. They were deeply concerned, saying <i>he was altering the patients’ records to help boost reimbursements for insurance claims,</i> Henry said.</blockquote><br />When Ms Henry complained, things did not go well, <br /><br /><blockquote class="tr_bq">Henry made her confidential call to the bankruptcy court in early November 2008, alleging potential fraud and threats to patient care that were eluding government notice [Ed - note that the hospital was going through bankruptcy proceedings and had just been acquired by a new owner]. The court forwarded her complaint to the U.S. Justice Department, the Texas attorney general’s office and the state health department, officials confirmed.<br /><br />Later that month, the state health department sent an inspector to the hospital. However, the visit was brief, Henry said, and the inspector didn’t interview her or seek her help in obtaining records.<br /><br />Williams, the health department spokeswoman, told <i>The News</i> her agency’s records show the inspector was unable to substantiate violations at the time.<br /><br /><i>Henry was terminated from Renaissance </i>as part of a 'restructuring'.... </blockquote>Then the hospital was cited for turning patients away from the emergency department,<br /><blockquote class="tr_bq">At Renaissance, <i>two women in labor, one bleeding, were refused treatment</i>. The inspection reports don’t reveal whether the women suffered complications because of the delays.<br /><br />A Renaissance employee told one of the women that if she 'could stand there and have a conversation with them then (she) wasn’t about to have a baby,' reports say.</blockquote><br />Then there were problems with infection control,<br /><br /><blockquote class="tr_bq">At Renaissance, <i>no supervision over infection control could be found</i>. For three months in the summer of 2010, no one was in charge of tracking infectious diseases or preventing their spread.</blockquote><br />The next year, the problem was blood transfusions<br /><br /><blockquote class="tr_bq">Inspectors returned to Renaissance in September 2011 to investigate a botched blood transfusion procedure. They found that <i>a registered nurse had not supervised the patient’s care</i>. In another case, an inspector witnessed an unsupervised vocational nurse administering blood to a patient, despite no evidence that she was competent to do so — another violation.</blockquote><br />In 2012,<br /><br /><blockquote class="tr_bq">During the summer, the Texas secretary of state had <i>revoked Renaissance’s business charter for failure to pay franchise taxes.</i><br /><br />That office didn’t share the information with the health department; it isn’t required to do so.<br /><br />In September, state health regulators notified Renaissance that they were proposing a $35,050 fine for 13 violations, including the nursing supervision failures, dating as far back as 2010.<br /><br />Williams, the health department spokeswoman, could not explain why the fine process took nearly two years since the first violation. </blockquote><br />Finally, in 2013, patients started to die,<br /><br /><blockquote class="tr_bq">In January of this year, when state inspectors returned to Renaissance, they found nursing supervision failures yet again.<br /><br />This time, <i>the failures had led to three deaths: All ER patients. All with severe breathing difficulties. All receiving little to no intervention as their conditions worsened.</i></blockquote><br />In particular,<br /><br /><blockquote class="tr_bq">[Eve] McCallum sought her own care after complaining of shortness of breath during a family dinner.<br /><br />McCallum had chronic obstructive pulmonary disease. When she was admitted, nurses were ordered to monitor her vital signs and oxygen levels. Her breathing soon improved, said her niece, Lou Ann Sims.<br /><br />'We were fully expecting to pick her up the next morning,' Sims said.<br /><br />Instead, they watched helplessly as her condition deteriorated. On Christmas Day, a physician explained to McCallum’s family that she had to be transferred to the intensive care unit.<br /><br />Later, Sims witnessed a scene she can’t let go of: Her aunt lay connected to a ventilator while a nurse stood smoking a cigarette just outside the door. The nurse had propped open the door with an IV pole.<br /><br />The family immediately <i>sought to have McCallum transferred to another hospital</i>. But hospital officials told them '<i>this would be a lateral move and was not allowed</i>,' according to a transcript of an interview the family later conducted with state officials.<br /><br />McCallum died two days later.<br /><br />Inspectors wrote that a licensed vocational nurse had been left in charge of her treatment, <i>without a registered nurse’s oversight</i>. There was no evidence an RN had assessed her condition on admission or was watching over her in the ICU.<br /><br />They could find <i>no doctor orders to place her on oxygen, no order for medications administered to her, 'nor evidence of communication with the M.D</i>.'<br /><br />Suspecting more than just care breakdowns at Renaissance, McCallum’s family reported her death to the Texas attorney general’s fraud-control unit.</blockquote><br /><br />So partially in response to this egregious case, <br /><br /><blockquote class="tr_bq">By February, the state health department had moved to <i>revoke Renaissance’s operating license</i>, and <i>CMS had ordered its federal funding terminated</i> — only the ninth time nationally in the last three years CMS had taken such a step.</blockquote><br />Even those steps could not shut down the hospital, but city officials took that last step due to the failure to pay taxes.<br /><br /><b>Other Hospitals</b><br /><br />Dallas News reporter Miles Moffeit found several other cases of severe problems at small hospitals owned by Dr Mahmood, with at least one patient death apparently resulting, .<br /><br /><br /><u>Shelby Regional Medical Center</u><br /><br />This hospital was owned by Tenet Healthcare, but was sold to another of Dr Mahmood's companies, Shelby Medical Holdings, in 2007 (look <a href="http://www.beckershospitalreview.com/hospital-management-administration/shelby-regional-medical-center-in-texas-closes-its-doors.html">here</a>).  <br /><br />In 2009, this hospital was also cited for providing insufficient treatment in the emergency department. <br /><br />In 2012, things were really falling apart,<br /><br /><blockquote class="tr_bq">In October 2012, inspectors were at Shelby chronicling dirty, clogged air-conditioners and failures to prevent <i>ceiling plaster 'from falling into the patient food service line and contaminating food</i>.' Those problems put patients’ safety in 'immediate jeopardy,' they wrote.<br /><br />As inspectors roamed Shelby’s halls in December, <i>the power suddenly went out</i> in four buildings, though not in the main hospital facility itself. The <i>electric bill hadn’t been paid</i>. They found other debts stacking up, too — as much as $190,442 owed to as many as 79 service providers.<br /><br />Signs of neglect were everywhere. <i>Only three of 20 patient rooms inspected were 'fully functional for patient care,' </i>they wrote. They found holes in walls, dirty and tattered curtains, and patients complaining of heat pouring from the faulty A/C system.</blockquote><br />Finally, in 2013, another patient died,<br /><br /><blockquote class="tr_bq">On Wednesday, <i>CMS cut off federal funding to ... Shelby Regional Medical Center</i> in Center in East Texas after regulators said <i>a patient rushed there by ambulance never received treatment from a doctor</i>.<br /><br />The ER physician wouldn’t leave his 'sleep room,' the inspection report said, resulting in the patient’s death. Regulators also cited the hospital for failing to vet backgrounds of doctors and nurses.<br /><br /></blockquote>Apparently soon thereafter Dr Mahmood shut the hospital down due to "legal issues that ... [he] is facing," <a href="http://lightandchampion.com/article/003856-mahmood-closes-shelby-regional-medical-center-staff-volunteers-time-until-doors-shut">per</a> the Shelby Light and Champion. <br /><br /><br /><u>Lake Whitney Medical Center </u><br /><br />Dr Mahmood apparently purchased this hospital from a struggling local hospital authority in 2007.   <br /><br />In 2009, it was cited for inadequate care in the emergency department,<br /><br /><blockquote class="tr_bq">At Lake Whitney, a nurse acknowledged to inspectors that she had <i>shredded records of a patient who was denied care following a fall</i>, according to a report. The 'patient wasn’t going to pay anyway,' the nurse was quoted as saying in the document.</blockquote><br />In 2010, there was evidence of major infrastructure problems,<br /><br /><blockquote class="tr_bq">At Lake Whitney, patients were served food on <i>rusty 'over-the-bed tables that were a source of possible infections for open wounds.' </i>Bulging ceiling tiles exposed pipes. Pavement outside a main hospital door was 'cracked and unlevel,' putting patients at risk of injury. </blockquote>As Dr Mahmood's legal troubles mounted, the hospital was sold to Frontier Hospitals Inc (look <a href="http://watchdogblog.dallasnews.com/2013/08/florida-company-takes-over-lake-whitney-medical-center-effectively-dissolving-embattled-owners-troubled-chain.html/">here</a>). <br /><br /><br /><u>Cozby-Germany Hospital </u><br /><br />I have been unable to discover when Dr Mahmood purchased this hospital.  <br /><br />In 2010, it became apparent that the hospital was not properly licensed, <br /><br /><blockquote class="tr_bq">'The administrator reported the new owner had not notified (CMS) … and <i>has not applied for hospital licensure </i>with the state licensing agency,' a report said. [The owner] ... also was found to have <i>appointed his own employees to the hospital’s governing board of directors, instead of independent outsiders</i>.</blockquote><br />And there were more severe problems with credentialing,<br /><br /><blockquote class="tr_bq">At Cozby-Germany hospital, hospital inspectors discovered that the <i>chief of staff and another doctor had expired medical licenses.</i> There were no 'functional' nurse and doctor credentialing processes, and clinical policies had not been updated since 2008, they said. The hospital pledged reforms.</blockquote><br />But in May 2011, records show, Cozby hired one of Texas’ most notorious doctors, Rolando Arafiles.<br /><br /><blockquote class="tr_bq">At the time, Arafiles had been placed on <i>probation by the medical board for allegations of harming nine patients, overbilling and improper coding </i>at a Winkler, Texas, facility, according the board. He also was <i>disciplined for intimidating the Winkler nurses </i>who blew the whistle on his practices.<br /><br />In November, Arafiles would be <i>convicted of two felonies linked to the retaliation and would surrender his license.</i></blockquote><br />In 2013, two local doctors purchased the hospital.<br /><br /><b>The Vanishing Owner</b><br /><br />What made this series of cases all the more amazing is that it was really one interlinked case.  All these hospitals, plus a few more, had the same owner.  Yet no one, especially  no one in state or federal government knew that until 2013 when the facts were uncovered by Mr Moffeit.<br /><br /><blockquote class="tr_bq">[Dr Tariq] Mahmood, a Pakistan-trained doctor, obtained his Texas medical license in 1978. Since 2008, he has practiced medicine only at his Central Texas Hospital in Cameron, south of Waco, records with the Texas Medical Board show. Older documentation is not available.<br /><br />Over the last two decades, <i>he has purchased at least six hospital companies and two home-health care agencies</i>, according to filings with the Texas secretary of state. He also has invested his money outside health care, acquiring the historic Hotel Lawrence in downtown Dallas, property records show.<br /><br />In addition to Renaissance, Shelby and Central Texas Hospital, Mahmood owns the Lake Whitney Medical Center in Whitney and Cozby-Germany Hospital in Grand Saline. He sold Community General Hospital in Dilley around the time of his arrest in April.<br /><br />The hospitals have <i>no common corporate identity</i> and little or no website presence, making it difficult for anyone to know they are owned by Mahmood or are part of a chain.</blockquote><br /><br />However, much bout Dr Mahmood was mysterious, and the deliberate cultivation of mystery might have slowed the response to this case. <br /><br /><blockquote class="tr_bq">Mahmood is rarely seen in the communities where his hospitals are located, say business associates and city officials. Sometimes they catch a glimpse of him passing by in a chauffeur-driven car.<br /><br />'He’s almost impossible to track down' to discuss business matters, said Tom Elliott, a director for a nonprofit company that owns the hospital building in Grand Saline. 'He lets his people do the talking.'<br /><br />Mahmood is a mystery to many of his own employees. He works almost entirely behind the scenes, they say, focusing largely on the business side of his operations. He often is traveling or spending time at his 10,000-square-foot gated estate in Cedar Hill, they say.<br /><br />'We see him maybe once a year,' said one of his hospital physicians. 'The employees say he doesn’t like confrontation. I say he just doesn’t like to communicate. He seems to live in a different world.'</blockquote><br /><b>Aftermath</b><br /><br /> At some point, the shadowy Dr Mahmood may have to answer for all this, at least to some extent, <br /><br /><blockquote class="tr_bq">In April, federal authorities charged the 62-year-old Cedar Hill resident with <i>defrauding Medicare and Medicaid programs through $1.1 million in false billings.</i><br /><br />Mahmood is accused of directing employees at his Central Texas Hospital in Cameron to alter underlying information in insurance claims from his other hospitals. 'In many cases,' the indictment alleges, these were 'for patients he had never seen.' Mahmood pleaded not guilty, and his attorney said he denies all charges. He has declined repeated interview requests from <i>The Dallas Morning News</i>. </blockquote><br />Note, however, that these are charges of financial fraud.  They do not obviously have to do with poor quality care, risks to patients' safety, or the deaths of at least three patients as discussed above.<br /><br />This case was so bad that even the current Governor of Texas, Rick Perry, a politician known for taking a small government, minimal regulation stance, at least said he was going to take some action, as <a href="http://www.dallasnews.com/investigations/patient-safety/headlines/20130719-perry-orders-investigation-into-oversight-of-troubled-rural-hospital-chain.ece">reported</a> again in the Dallas News,<br /><br /><blockquote class="tr_bq">The governor’s office has ordered a 'deep and comprehensive look' at health care facilities owned by Dr. Tariq Mahmood, whose chain of rural Texas hospitals avoided serious regulatory action despite years of endangering patients.<br /><br />The inspector general for the state Health and Human Services Commission and one of the agencies it oversees, the state health department, will conduct separate investigations, officials said Friday.</blockquote><br />And in February, 2014, the Dallas News <a href="http://www.dallasnews.com/investigations/20140206-texas-hospitals-chief-faces-fraud-charges-over-use-of-stimulus-grants.ece">reported</a> that the chief financial officer of the Dr Mahmood's stealth hospital chain was also in hot water,<br /><br /><blockquote class="tr_bq">The top administrator of a chain of hospitals that collapsed under the ownership of a North Texas physician faces charges that he defrauded the federal government of nearly $800,000 in stimulus funds.<br /><br />Joe White of Cameron <i>rose from maintenance man to head administrator and chief financial officer</i> over hospitals once owned by Dr. Tariq Mahmood. Now he joins Mahmood in facing the possibility of prison time.<br /><br />Like Mahmood, who pleaded not guilty, White is accused of identify theft and bilking the federal government of health care dollars. White has yet to enter a plea.</blockquote><br />Note that the CFO and apparently COO was not even a professional generic manager.  He was a former maintenance man  and operator of a Radio Shack store..  <br /><br />Dr Mahmood has not yet come to trial.  Many questions about the case remain unanswered:<br /> -  Did Mahmood the only person besides his CFO cum maintenance man in charge of all this, or did he have other backers,  cronies, associates?<br />-  What happened to the rigorous state investigation promised by Rick Perry?<br />-  Given that what went on harmed patients, and hence was not just financial manipulation, are there any civil lawsuits pending?  Are there any other criminal investigations?\<br /><br />Furthermore, despite its egregious nature, this case was amazingly <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a>  The only national recognition I could find was i<a href="http://runningahospital.blogspot.com/2013/07/hospital-slumlord.html">n Paul Levy's Not Running a Hospital blog.</a>  Seven months later, I could find nothing in the national media, nothing in medical and health care literature.  Despite the amazingly poor quality of care in evidence, despite the fact that patients died, I could find no cries of outrage from those who proclaim to support quality health care or patient safety.  <br /><br /><br /><b>Summary</b><br /><br />Dr Mahmood and his chief operating and financial officer collectively displayed leadership that was ill-informed (the COO/ CFO was a former maintenance man), incompetent (see the egregious health quality problems listed above), self-interested (note the size of Dr Mahmood's mansion versus how little was obviously spent on his hospitals), opaque and dishonest (note how Dr Mahmood's ownership of the hospitals was obscured), and allegedly criminal.  This leadership persisted over at least eight years until it culminated in cases of apparently needless patient deaths.   <br /><br />The amazing case of the stealth for-profit hospital system run by Dr Mahmood, and how its combined problems failed for so long to get systemic regulatory notice hardly suggest that our health care system is heavily regulated, or that current regulation can be relied upon to reassure patients that all is well and that the system is safe.<br /><br />In fact, in the case of Dr Mahmood, government regulators did not seem to even want to know too much about hospital ownership,<br /><br /><blockquote class="tr_bq">Top health regulators weren’t even aware Mahmood owned several hospitals until <i>The News</i> sought information about them earlier this year. <i>Regulatory agencies aren’t set up to track problem hospital owners or hold them accountable. Nor do they look for patterns of care breakdowns inside hospital chains.</i><br /><br /><i>'We just don’t have that authority,'</i> said David Wright, deputy regional administrator for CMS. The federal agency oversees the state health department’s inspections of federally funded hospitals. 'We can only address problems in stand-alone facilities.'</blockquote><br /><br />Furthermore, it appears that modern regulators have decided to become hospital managers' and owners' best friends,<br /><br /><blockquote class="tr_bq">The process allows hospitals to <i>avoid sanctions if they cooperate</i>. Hospitals submit “corrective action plans” to remedy failures. It can take months for state regulators to bring penalties such as fines against a facility. In the case of Renaissance, it took years.<br /><br />'We want to do what’s in the best interest of the patients, and our regulatory philosophy is <i>to get hospitals into compliance,</i>' said Carrie Williams, spokeswoman for the Texas Department of State Health Services. '<i>We’re not in the business of shutting down hospitals. We will give them some leeway and work with them.'</i></blockquote><br />Of course, this minimalist, light touch regulatory methodology may have made some sense in an earlier era when nearly all hospitals were small community not-for-profit organizations, non-profit academic institutions, or were run by local governments.  It seems quaint, and hopelessly out of date in an era when most hospitals are part of <a href="http://hcrenewal.blogspot.com/search/label/hospital%20systems">ever larger systems,</a> now often owned for-profit corporations, and when hospital system CEOs who are professional, and thus <a href="http://hcrenewal.blogspot.com/search/label/generic%20managers">generic managers</a>, not health care professionals, in an era of <a href="http://hcrenewal.blogspot.com/search/label/financialization">financialization</a> and "maximizing shareholder value," that is, making short-term revenue the most important outcome.<br /><br />Instead, the current minimalist regulatory system seems insufficient to prevent patients from dying of poor care allowed by poor leadership of health care organizations.  Much of the content of this blog has been about bad health care leadership, i.e., leadership that is <a href="http://hcrenewal.blogspot.com/search/label/ill-informed%20management">ill-informed</a>, incompetent, unsympathetic or <a href="http://hcrenewal.blogspot.com/search/label/mission-hostile%20management">hostile to health care professionals' values</a>, self-interested, <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicted</a>, dishonest, or even <a href="http://hcrenewal.blogspot.com/search/label/health%20care%20corruption">corrupt</a>.  In my humble opinion, health care regulation ought to be sufficient to promote competent, caring, unconflicted, honest leadership that is accountable for putting patients' interests ahead of self-interest.  Regulation needs to be more intense, and much smarter, geared to the reality of a health care system that is now largely for-profit in an era when management dogma puts revenue ahead of all other concerns.<br /><br />Maybe the deaths of some patients in Dr Mahmood's Texas hospital will finally let the air out of the mindlessly anti-regulatory bubble, and start some discussion of intelligent regulation to improve patient safety.<br /><br />However, that cannot happen if this case remains anechoic.  I regret it took me so long to find it, but now I have done my part to start some echoes.  But where are the media, where are the journal editors, and where are those who so loudly proclaim their interest in patient safety and health care quality?<br /><br />In particular, there are several prominent organizations that claim to promote health care quality and patient safety.  These organizations make these claims- <br /><br /><a href="http://www.jointcommission.org/topics/patient_safety.aspx">Joint Commission</a><br /><br /><blockquote class="tr_bq"> For more than 60 years, The Joint Commission has been a <i>champion of patient safety</i> by helping health care organizations to improve the quality and safety of the care they provide. </blockquote><br /><a href="http://www.leapfroggroup.org/about_leapfrog">Leapfrog Group</a><br /><br /><blockquote class="tr_bq"> The Leapfrog Group is a voluntary program aimed at mobilizing employer purchasing power to alert America’s health industry that <i>big leaps in health care safety, quality</i> and customer value will be recognized and rewarded.</blockquote><br /><a href="http://www.qualityforum.org/who_we_are.aspx">National Quality Forum</a><br /><br /><blockquote class="tr_bq"> <i>Transforming our healthcare system to be safe</i>, equitable, and of the highest value will take time and the work of many, but the potential rewards are great. The National Quality Forum (NQF) is a nonprofit, nonpartisan, public service organization committed to this transformation. </blockquote><br /><a href="http://www.rwjf.org/en/about-rwjf/our-mission.html">Robert Wood Johnson Foundation</a><br /><br /><blockquote class="tr_bq">Our efforts focus on improving both the health of everyone in America and their health care—how it's delivered, how it's paid for, and <i>how well it does for patients and their families. </i></blockquote><br />These  organizations should the ones to start the conversation about improving rather than forever shrinking regulation.   I have not heard anything from them about the deadly hospitals of Dr Mahmood.  Are they listening now?  Will we ever hear from them?  Time will tell....  <br /><br /> Note: the entire Dallas News series on the Mahmood hospitals can be found <a href="http://res.dallasnews.com/interactives/collapseofcare/">here</a>.  <br /><br />

To Die in Texas - Dr Mahmood's Apparently Fatal Stealth Hospital System Collapses Nearly Anechoically

I would bet that most people in the US still think our health care system is highly regulated.  Some may thus conclude that the system is ba...

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InformaticsMD on NPR Affiliate KNPR regarding electronic medical record privacy: St. Rose hospital group used patient information to solicit patient lobbying?

<span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">Radio station <b><a href="http://www.knpr.org/">News 88.9 KNPR</a></b>, the NPR affiliate in Las Vegas</span><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;"> did </span><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">a segment today on the following news story.  The station's Senior Producer had invited me to participate via phone regarding patient privacy issues.</span><br /><div class="MsoNormal"><br /><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">Emphases mine: </span></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;"> </span></div><blockquote class="tr_bq"><div class="MsoNormal"><a href="http://www.reviewjournal.com/news/federal-complaint-alleges-st-rose-hospitals-violated-patient-privacy"><span style="font-family: "Arial","sans-serif"; font-size: small;">http://www.reviewjournal.com/news/federal-complaint-alleges-st-rose-hospitals-violated-patient-privacy</span></a><br /><br /><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">February 10, 2014 - Updated  February 11, 2014 <br /><b>Federal complaint alleges St. Rose Hospitals violated patient privacy</b><br /><br />By STEVEN SLIVKA<br />LAS VEGAS REVIEW-JOURNAL<br /><br />Dignity Health, the owner of St. Rose Dominican Hospitals, is f<b>acing a federal complaint alleging it violated patient privacy by using patient records as leverage in a contract dispute.</b><br />According to a Monday announcement from the Nevada Health Services Coalition, Dignity Health <i><b>used patient records to contact those with coalition member plans after agreements between the two agencies fell through in January</b></i>, something it contends violates the Health Insurance Portability and Accountability Act, or HIPAA. The complaint was filed with the U.S. Department of Health and Human Services Office of Civil Rights.<br /><br />The complaint contends <i><b>St. Rose contacted former patients in an attempt to persuade them to take action with their health plans favorable to St. Rose. </b></i>The complaint also said that St. Rose claimed their actions were simply to be “informative.”<br /><br />“It’s our position that patient data collected in the course of medical treatment should not be used to lobby or gain leverage in contract negotiations,” said Christine Carafelli, executive director of the coalition.<br /><br />The Nevada Health Services Coalition is a nonprofit entity that negotiates hospital contracts for discounted health care service rates for 19 member group organizations, totaling approximately 230,000 Nevada residents.<br /><br />A spokesperson for St. Rose said they would issue a statement on Tuesday.  </span></div></blockquote><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">The segment has now completed.  It was hosted by Dave Becker of KNPR.</span></span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">A representative of the <b>Health Services Coalition</b> (<a href="http://www.lvhsc.org/">http://www.lvhsc.org/</a>), a local organization of union, casino and local government health funds who bargain together for maximum leverage, participated, as did a hospital VP. </span><br /><br /><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">The coalition is accusing the St. Rose hospital group (a division of Dignity Health) <i><b>of using patient records to contact patients to urge them to lobby for the hospital in contract negotiations.</b></i></span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">I was asked for an opinion on the acceptability of access to patient information in an organization's EHR systems (including PHI such as name, address and other contact information) for purposes of soliciting the patients to lobby the insurers on behalf of the healthcare organization for better terms.</span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">My opinion was clear, which I summarize as follows:</span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">1.  Hospitals do not "own" patient data to use as they please.  Is is not a simple business asset, like typewriters - or computers.  Any belief that a hospital can treat patient records as such, to be used as they pleased, would reflect arrogance;</span><br /><br /><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">2.  The HIPAA privacy rule and its exceptions (viewable at <a href="http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/">http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/</a>, section under "</span><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;"><b>Permitted Uses and Disclosures</b>") would preclude the use of patient's private and protected information in an EHR for selective solicitation for lobbying on behalf of the hospital;</span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">3.  Who accessed the patient information, and exactly what they accessed, is not clear, and an electronic audit trail needs to be disclosed as to these issues;</span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">4.  Harm could potentially come to patients if someone who accessed the information, who otherwise </span><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">might not have</span>, used it to advantage for other purposes.  This includes, for example, uses outside of the medical sphere (e.g., personal use by, say, a neighbor or competitor).  I am aware of cases of such abuse, as is HHS and so are hospitals (see my blog query links on medical record privacy and confidentiality at <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20confidentiality">http://hcrenewal.blogspot.com/search/label/medical%20record%20confidentiality</a> and <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy</a>); and:</span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">5.  The hospital could have accomplished such goals transparently, safely, and without access to private health information, by putting an ad on the radio (or newspaper etc.), or mailing a general newsletter such as I often receive from area hospitals, even hospitals where I was never a patient.</span></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;"><br /></span></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">A hospital VP contributed soothing words that the hospital respects patient privacy, trusts its employees and doesn't wish this matter to become a stumbling block in negotiations.  However, in my opinion the hospital violated the HIPAA privacy rules and potentially put patient privacy at risk. </span><br /><br /><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">No amount of soothing, deflecting executive language and shifting of the discussion can change that, and a full disclosure accounting would be proper.  </span><br /><br /><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">(I note the HIPAA privacy rules do <b>not</b> state "<i>For informational purposes only.  Use patient information however you want if you trust your employees and you think the risk is low..</i>")</span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">That is, assuming an audit trail of sufficient detail is recorded in their EHRs, assuming it is turned on, and assuming it can be trusted in light of the HHS OIG report of Dec. 2013 where many hospitals admitted EHR audit trails can be deleted or edited by a person with appropriate credentials.  (See my Dec. 10, 2013 post <b>"</b></span><b>44% of hospitals reported to HHS that they can delete the contents of their EHR audit logs whenever they'd like" </b>at <a href="http://hcrenewal.blogspot.com/2013/12/44-of-hospitals-reported-to-oig-that.html">http://hcrenewal.blogspot.com/2013/12/44-of-hospitals-reported-to-oig-that.html</a><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">).</span></div><div class="MsoNormal"><br />The segment audio is online here: <a href="http://www.knpr.org/son/archive/detail2.cfm?SegmentID=10939">http://www.knpr.org/son/archive/detail2.cfm?SegmentID=10939</a><br /><br /><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">-- SS </span><br /><b><br /></b><b><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">Feb. 14, 2014 Addendum:</span></b><br /><br /><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">A thought experiment demonstrates just how far from propriety, in my opinion, this affair is:</span><br /><br /><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">If a hospital can use confidential information in this manner, to enlist patients as de facto lobbyists regarding an insurer, then why could not a hospital use other data - e.g., patients' disease burden, smoking status or even sexual orientation to ask them to lobby, say, a politician to gain some advantage, such as certificate-of-need approval for expansion, or anti-competitive legislation?  Or, to ask patients to participate in political activities for/against some politician or group that might hold views or conduct activities favorable/unfavorable to the hospital's interests?</span><br /><br /><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">-- SS </span></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;"><br /></span></div>

InformaticsMD on NPR Affiliate KNPR regarding electronic medical record privacy: St. Rose hospital group used patient information to solicit patient lobbying?

Radio station News 88.9 KNPR , the NPR affiliate in Las Vegas did a segment today on the following news story.  The station's Senior Pr...

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"Can't This be Avoided?" - How Corporate Marketers Manipulated a Clinical Research Report to Avoid "Undermining" Marketing Messages

Documents newly made public in the course of litigation about the drug Pradaxa show granular details about how clinical research may be manipulated by corporate research sponsors intent on marketing their products.<br /><br /><b>Background</b><br /><br />As <a href="http://www.nytimes.com/2014/02/06/business/study-of-blood-clot-drug-pradaxa-unnerved-its-maker-documents-suggest.html">reported</a> by the New York Times, the litigation is over allegations by thousands of patients and families that privately held Boehringer Ingelheim concealed the bleeding risks of the anticoagulant drug Pradaxa.  <br /><br /><blockquote class="tr_bq">Pradaxa and two other recently approved drugs, Xarelto and Eliquis, are in a race to gain market share from warfarin, a generic drug that for decades has been the standard treatment for preventing blood clots and strokes. Many patients viewed the older warfarin as a nuisance because it requires frequent blood tests and careful attention to diet and other drugs.<br /><br /><div class="story-body-text story-content" data-para-count="190" data-total-count="2310" itemprop="articleBody">The new drugs do not require such monitoring, yet claim to be as good, or better, at preventing strokes and blood clots in patients with a heart-rhythm disorder known as atrial fibrillation.</div></blockquote><div class="story-body-text story-content" data-para-count="190" data-total-count="2310" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="190" data-total-count="2310" itemprop="articleBody">However,</div><div class="story-body-text story-content" data-para-count="190" data-total-count="2310" itemprop="articleBody"></div><div class="story-body-text story-content" data-para-count="190" data-total-count="2310" itemprop="articleBody"> </div><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="180" data-total-count="747" itemprop="articleBody">Since its approval in 2010, the drug, <a href="http://www.nytimes.com/2012/11/03/business/a-rising-anti-stroke-drug-is-tied-to-risk-of-bleeding-deaths.html" title="From the archives.">which can cause fatal bleeding</a>, has brought in more than $2 billion in sales in the United States, according to the research firm IMS Health. </div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody">It has been prescribed to 850,000 patients, but has also been linked to more than 1,000 deaths. </div></blockquote><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"><b>Internal Documents Show the Influence of Marketers on a Clinical Research Report</b></div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody">As summarized by the NY Times, </div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"> The makers of the blood-thinning drug Pradaxa were so worried that an internal research paper would damage drug sales that some employees not only pressured the author to revise it, but suggested it should be quashed altogether, according to newly unsealed legal documents.</div></blockquote><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody">In particular,</div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"> </div><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="463" data-total-count="2773" itemprop="articleBody">The documents show that Boehringer Ingelheim employees <i>openly fretted when it appeared that the results of the research paper, written by Paul A. Reilly, a clinical program director at the company, indicated that some patients could benefit from monitoring of their blood</i>. A certain segment of patients, the paper found, absorb too little of the drug to effectively prevent strokes, while another group absorbs so much that they are at a higher risk for bleeding.</div><div class="story-body-text story-content" data-para-count="463" data-total-count="2773" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="272" data-total-count="3045" itemprop="articleBody"><i>In a draft version of the paper included in the court records, Dr. Reilly and his co-authors detailed specific levels of how much Pradaxa should be in a patient’s bloodstream, and said that keeping some patients within that range would help prevent strokes and bleeding.</i></div><div class="story-body-text story-content" data-para-count="149" data-total-count="3194" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="149" data-total-count="3194" itemprop="articleBody">As Dr. Reilly’s draft paper circulated within the company, some employees <i>questioned what the marketing implications</i> of such a conclusion would be.</div><div class="story-body-text story-content" data-para-count="269" data-total-count="3463" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="269" data-total-count="3463" itemprop="articleBody">One company supervisor, Dr. Jutta Heinrich-Nols, wrote in an email to other employees that <i>she could not believe the company was planning to publish research that would negate a decade’s worth of work proving that patients taking Pradaxa would not need regular tests.</i></div><div class="story-body-text story-content" data-para-count="185" data-total-count="3648" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="185" data-total-count="3648" itemprop="articleBody">Publishing the research results, she warned, could <i>make it 'extremely difficult' for the company to defend its long-held position to regulators that Pradaxa did not require testing</i>.</div><div class="story-body-text story-content" data-para-count="183" data-total-count="3831" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="183" data-total-count="3831" itemprop="articleBody">And, Dr. Heinrich-Nols added in the email, the research, if known, would <i>'undermine' the company’s efforts to compete with other new anticoagulants, such as Xarelto and Eliquis.</i></div><div class="story-body-text story-content" data-para-count="183" data-total-count="3831" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"> 'I would like to ask you to <i>check again whether this is really wanted</i>,' she wrote about publishing the research.</div></blockquote><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody">A second NY Times <a href="http://www.nytimes.com/2014/02/08/business/new-emails-in-pradaxa-case-show-concern-over-profit.html">article</a> added more details,</div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"></div><div class="story-body-text story-content" data-para-count="176" data-total-count="2486" itemprop="articleBody">In one email, from June 2012, an employee wonders about the implications of internal research showing that blood levels of Pradaxa could vary significantly in a single patient.</div><div class="story-body-text story-content" data-para-count="269" data-total-count="2755" itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="269" data-total-count="2755" itemprop="articleBody">'This may not be a onetime test and could result in <i>a more complex message (regular monitoring), and a weaker value proposition … vs. competitors,</i>' wrote the employee, whose name was redacted in accordance with privacy laws in Germany, where the company is based.</div><div class="story-body-text story-content" data-para-count="269" data-total-count="2755" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="453" data-total-count="3208" itemprop="articleBody">In another, an employee — whose name was also removed — asks about whether a newly available blood test in the United States might be useful for doctors treating patients with Pradaxa, which is also known as dabigatran. Another replies that such a test could be developed 'in-house,' but '2 years ago <i>there was an informed decision NOT to develop this</i>.' The employee continued, '<i>this would go against the ‘no monitoring’ idea/claim.'</i></div><div class="story-body-text story-content" data-para-count="453" data-total-count="3208" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="231" data-total-count="3439" itemprop="articleBody">Employees also continued to question the merits of allowing a research paper to be published showing that some patients could benefit from monitoring of their blood. The paper was <a href="https://content.onlinejacc.org/article.aspx?articleid=1748241&resultClick=24">published on Tuesday</a> but with some details removed.</div><div class="story-body-text story-content" data-para-count="231" data-total-count="3439" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="198" data-total-count="3637" itemprop="articleBody">'This publication will <i>more harm than be useful for us, neither in the market but be especially harmful in the discussions with regulatory bodies</i>,' one email read. '<i>Can’t this be avoided</i>?'</div></blockquote><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody">So, in summary, Pradaxa has been marketed basically on its convenience, as a drug whose dosage need not be customized according to frequent blood tests, in contrast to cheaper generic warfarin whose dosage may need adjustment according to frequent blood tests.  Yet a clinical trail sponsored by Boehringer Ingelheim, the manufacturer of Pradaxa, seemingly showed that its risk of bleeding might be dependent on its blood level, and hence perhaps that its dosage <i>should</i> be varied according to blood test.  </div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody">However, the manuscript reporting the results of this trial was apparently subject to vetting by multiple company managers whose specific concerns were whether the results of this research "undermined" the marketing message, and hence whether these results should be changed or suppressed to avoid contradicting the company's intended marketing message.   </div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody">Let me try to add some context, based on my experiences in academic medicine writing research papers, commenting on colleagues' papers, and reviewing papers for journals.  Considerable discussion among the researchers and clinicians involved in research projects about how manuscripts are worded is the norm.  However, working a perhaps more innocent era, input from people with vested interests in the project producing a particular result was unheard of.  Many health care professionals thus may still act based on the idealistic assumption that clinical research reports are all about science, and not about marketing. </div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"><b>Was the Manipulation Successful?</b></div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody">A Medscape <a href="http://www.medscape.com/viewarticle/820324">article</a> noted that the published version of the research article </div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody">found ischemic stroke and bleeding risks were correlated with plasma concentrations of the drug in 9183 patients treated with dabigatran 110 mg or 150 mg twice daily (the available European doses). In their logistic regression analysis, the risk of ischemic stroke was inversely associated with trough concentrations of dabigatran. </div><br />The researchers concluded that 'the magnitude of the effect of dabigatran plasma concentrations on outcomes in atrial-fibrillation patients in <b> <a href="http://www.medscape.com/viewarticle/708133" target="_blank">RE-LY</a> </b> depends strongly on demographic factors, most importantly increasing age.' However, the results also confirmed a wide therapeutic range among those treated with dabigatran, with a more than fivefold variation in plasma concentrations. The researchers concluded there might be a subset of patients who could improve their risk/benefit profile by tailoring the dose of dabigatran. </blockquote><br />However,<br /><br /><blockquote class="tr_bq">In the paper, <i>there are no references to the optimal plasma concentration of dabigatran,</i> although such statements were in various drafts that circulated throughout the company, according to the New York Times.  When the paper was published online in October, Reilly told Reuters news  that the 'there is no single plasma concentration range that provides optimal benefit-risk for all patients" and that "no monitoring is necessary.' [see relevant Medscape article <a href="http://www.medscape.com/viewarticle/812871">here</a>.]</blockquote><br />So it does appear that the final version of the article included a discussion that was influenced by the marketers' wishes that the results would not appear to contradict the marketing party line. <br /><br />A rigorous review of the article might have suggested that varying the dosage of the drug according to its blood level might reduce bleeding risk, and hence increase its benefits versus its harms.  However, a casual reading might not have revealed that the data in the study undermined the marketing message that Pradaxa is a better drug than warfarin because it can be given at a fixed dose without the need for inconvenient blood tests.  Thus, the efforts by the marketers to alter the dissemination of the clinical research to support marketing messages and increase sales of the drug and resulting revenues - never mind what the data showed - appeared to be successful. <br /><br /><b>Conclusions</b><br /><br />This case study, only made possible by the public release of internal corporate documents in the course of litigation, suggests that in retrospect the dissemination of the results of one particular clinical trial were manipulated in a somewhat subtle way so that the data would not contradict a marketing message that now appears rather fictional.<br /><br />In the absence of litigation, and of a judge willing to make public documents that one party to the litigation doubtless wanted to hide, the manipulation of this particular study might never have been apparent.  Most clinical research is now sponsored by health care corporations with vested interests in how the research turns out.  Much of this research could be manipulated by corporate marketers who wish it to support their marketing messages, the truth be damned.  We (and others) have discussed many <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">examples of apparent manipulation of clinical research</a>, <br /><br />However, it is unlikely that we, physicians, health care professionals, health care researchers and policy makers, and the public, will ever know for such which studies were manipulated.  At best, very critical, skeptical, rigorous review can suggest which studies might have been manipulated. In the absence of such review, we are in danger of being swamped in a morass of manipulated research, and thus lead to make clinical decisions that are based mainly on hucksterism, not science.<br /><br />Thus, I strongly advocate that those who author authoritative systematic reviews, meta-analyses, and clinical practice guidelines base their work on extremely rigorous, skeptical reviews that assume the likelihood that all commercially sponsored published clinical research has been manipulated (and that research that even post manipulation could not be twisted to support marketing many have been <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppressed</a>)  Reviews, meta-analyses, and guidelines that were not so based on extremely critical review should also be viewed with a jaundiced eye.  <br /><br />Perhaps it is possible to devise legal and regulatory methods to at least make such manipulation more transparent.  Maybe this case, however, should again suggest that clinical research, that is, research on human beings, should be completely separated from those with vested interests in selling products or services which could be better hyped were the research turn out in their favor. 

"Can't This be Avoided?" - How Corporate Marketers Manipulated a Clinical Research Report to Avoid "Undermining" Marketing Messages

Documents newly made public in the course of litigation about the drug Pradaxa show granular details about how clinical research may be mani...

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H.R.2957 and its proposal to limit eDiscovery of potentially admissible and material evidence in EHR-related medical disasters

Do computers have more rights than patients?<br /><br />It often appears that way to me. <br /><br />Health IT and its industry sector seem to garner extraordinary regulatory accommodations compared to other healthcare and life-critical sectors - such as freedom from meaningful safety regulation, freedom from need for human research subjects protections and informed consent on EHR risks ... and in this proposal, freedom from full legal Discovery:<br /><br />US Congress has a bill, <b>H.R.2957 - Behavioral Health Information Technology Act of 2013</b>, 113th Congress (2013-2014), at <a href="http://beta.congress.gov/bill/113th/house-bill/2957" target="_blank">http://beta.congress.gov/bill/<wbr></wbr>113th/house-bill/2957</a>) with a section (SEC. 4. <b>PROVIDING PROTECTIONS FOR CERTAIN PROVIDERS, VENDORS, AND USERS OF CERTIFIED EHR TECHNOLOGY</b>) that provides safe harbors for reporting EHR-related errors.<br /><br />The text of Sec. 4 contains this<span style="font-size: small;"><span style="font-family: inherit;">:</span></span><br /><br /><blockquote class="tr_bq"><span style="font-size: small;"><span style="font-family: inherit;">... (c) Rules Relating to E-Discovery.--In any health care lawsuit against a covered entity that is related to an EHR-related adverse event, with respect to certified EHR technology used or provided by the covered entity, electronic discovery <u><i>shall be limited to</i></u>--<br /><b>        (1) information that is related to such EHR-related adverse event; and<br />        (2) information from the period in which such EHR-related adverse event occurred.</b> </span></span></blockquote><br />In other words, it seems the bill proposes, on capricious grounds, that an injured party cannot discover any information from <u><i><b>prior</b></i><b><i> to</i></b></u><b> </b>- or <u><i><b>after</b></i></u> - the EHR-related event they allege caused their injury, even if potentially material; for example, if the cause of the event was known about and had occurred in the past to others, or afterwards, yet went uncorrected.<br /><br />This seems a shield against claims of EHR vendor and/or healthcare organization corporate negligence and seems to represent anther special accommodation to health IT.<br /><br />This proposed Bill would also, it seems, <b>hamper </b><i><b>clinicians</b> who were themselves victims of bad health IT </i>from fully defending themselves.<br /><br />How this Bill's eDiscovery infringement promotes timely correction of known EHR problems, I would like to know...<br /><br />I also fail to see what "certification" has to do with provision of this remarkable special accommodation regarding eDiscovery.<br /><br />"Certification" by HHS/ONC is a features qualification/verification of features felt by committee (with no real basis in Evidence-Based Medicine principles) to foster "meaningful use", whatever that means, and make an EHR product eligible for CMS incentives.<br /><br />However, "certification" is <b>not</b> a safety testing or validation process, in the words of the certification bureaus themselves, see my Feb. 2012 post <b>"Hospitals and Doctors Use Health IT at Their Own Risk - Even if 'Certified'"</b> at <a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html">http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html</a>.<br /><br />Finally (and with the caveat that neither I nor my colleagues are lawyers), colleagues point out that such a proposal from Congress may be at odds with the role of the government branch that <i>does </i>decide the Rules of Civil Procedure, including discovery rules.  Specifically, the judiciary, at both the Federal court level (e.g., per the <span dir="auto"><b>Rules Enabling Act</b> of 1934, an Act of Congress that gave the judicial branch the power to promulgate the Federal Rules of Civil Procedure,  <a href="http://en.wikipedia.org/wiki/Rules_Enabling_Act">http://en.wikipedia.org/wiki/Rules_Enabling_Act)</a>, and State levels.</span><br /><span dir="auto"><br /></span><span dir="auto">It would seem quite possible that the roster of Congressional co-sponsors of this Bill, seen at <a href="http://beta.congress.gov/bill/113th/house-bill/2957/cosponsors">http://beta.congress.gov/bill/113th/house-bill/2957/cosponsors</a>, have been "influenced" by the health IT industry.</span><br /><span dir="auto"><br /></span><span dir="auto">-- SS</span>

H.R.2957 and its proposal to limit eDiscovery of potentially admissible and material evidence in EHR-related medical disasters

Do computers have more rights than patients? It often appears that way to me. Health IT and its industry sector seem to garner extraordinary...

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