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Transplant Team at UPMC Missed Hepatitis Result - Suspicious for Health IT Failure?

A story suspicious for EMR malfunction appeared in the Pittsburgh Post Gazette: <a href="http://www.post-gazette.com/pg/11141/1148149-114-0.stm"> </a><blockquote><a href="http://www.post-gazette.com/pg/11141/1148149-114-0.stm">Transplant team missed hepatitis result</a> <div class="story_subheadline"> Kidney donor, recipient unaware of virus' presence</div> <div class="story_lastupdate">Saturday, May 21, 2011</div> <div class="story_byline">By Sean D. Hamill and Jonathan D. Silver, Pittsburgh Post-Gazette The living donor and recipient of a recently flawed kidney transplant at UPMC are a couple who did not know that the donor, a woman, was hepatitis C positive, and didn't find out until after the kidney was transplanted into the man [which stunningly implies the entire transplant team didn't know, either - ed.], sources told the Pittsburgh Post-Gazette. The woman was tested for hepatitis C prior to surgery, and the results showed she was positive for the virus, but the two people on the transplant team who should have checked the results and stopped the transplant, failed to do so, sources also said. [Or was the data missing? Something is not right here. What, exactly, was checked, and what, exactly, was not checked? Did they also check for other infectious diseases such as HIV, hepatitis A, B, etc., or did they "miss" them, too? See below - ed.] On May 11, two days after the transplant became public, a board member said Elizabeth Concordia, UPMC's executive vice president, gave a 20-minute presentation to the hospital system's board of directors during its regular meeting and told them that the positive test was missed during 12 steps throughout the process. The failure to act on the positive test was so serious that it was considered a "systemic" problem in the way the protocols failed in this one case, Ms. Concordia said, according to the board member, and that's why UPMC voluntarily shut down its living donor transplant program May 6. [A rather extreme measure - ed.] The program will remain closed until an investigation is completed and new protocols can be drawn up to prevent the error from occurring again. The hospital system would not confirm these details or release a copy of its internal protocols that would show who on the transplant team should have reviewed the test results. Because of the current federal, state, county and internal investigations, "I don't think it's appropriate for us to say right now what the protocols are," said UPMC spokeswoman Jennifer Yates. "But we are reviewing everything to ensure it is not a systemic problem" beyond this one case. Ms. Yates said UPMC has done 975 living donor kidney transplants since 1988 and this is the only known case of a hepatitis C positive donor kidney being transplanted into someone who was hepatitis C negative. The error was discovered by UPMC, which self-reported it to the Centers for Medicare and Medicaid Services (CMS), and it was not related to a review by CMS that was "coincidentally" ongoing at the time of the discovery at Children's Hospital of Pittsburgh of UPMC, a CMS spokeswoman said.</div> </blockquote><div class="story_body"> This hepatitis-C fiasco to my eye seems a likely case of IT error of omission or transmission (EOT, see Tables 4 and 5 at the FDA internal memo I cached at <a href="http://www.blogger.com/redir.aspx?C=1602b58534374db09c306e05ab7125ac&URL=http%3a%2f%2fwww.ischool.drexel.edu%2ffaculty%2fssilverstein%2fInternal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf" target="_blank">http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf</a>). It's inconceivable to me experienced transplant personnel, used to checking for data such as HIV, hepatitis status of donor and recipient, and other blood abnormalities would just miss this. I would believe the hepatitis status, e.g., Hepatitis A, B, C, would be presented on the same screen. (If not, that's a design flaw itself.) That the Hep-C value could be missed by more than one person [possibly many people; see addendum below -ed.] seems very unlikely - even if the presentation screen(s) were cryptic and poorly organized. A more plausible explanation to me is that a positive result simply wasn't present at the time when it was needed, e.g., due to a Laboratory Information System (LIS)-Hospital Information System (HIS) interface problem, or a HIS data erasure or misidentification error after the data was correctly received. Another issue: For the hundreds of millions of dollars spent on computers at this medical center, I wonder why their "system" in critical areas such as transplantation (as it would appear from the reports) is entirely dependent on two people looking at data. After all, the IT is "supposed" to reduce error by infallibly calling attention to critical abnormalities such as this. The EMR alerting systems should have been going off like cockpit stall warnings at the data combination of "transplant" and "hepatitis C". That's not rocket science. This further supports my hypothesis of a health IT malfunction, as does what I read about their "shutting down the living donor transplant program" for now - an extreme measure if this medical error were merely the result of a person or persons simply forgetting to check a data screen or sheet. More generally, in a nutshell: commercial health IT from the current sellers is a fiasco. It alone among medical devices is unregulated under the FD&C Act <a href="http://www.emrupdate.com/forums/t/27502.aspx">even though FDA admits it is a medical device</a>, it is <a href="http://hcrenewal.blogspot.com/2011/03/brief-primer-on-health-it-problems.html">unsafe</a>, the literature shows its <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/HITreadinglist.doc">benefits grossly exaggerated</a>, it probably cannot be made to work considering the current HIT "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=ecosystem">ecosystem</a>" and its pathologies and incompetents, and has only <a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/05/15/AR2009051503667.html?hpid=topnews">captured the market</a> through the purveyors "<a href="http://hcrenewal.blogspot.com/2011/03/how-lousy-health-it-gets-pushed-on.html">controlling the channel</a>" of information and memes through their massive trade association HIMSS and political connections to HHS. Think tobacco circa 1940's-1950's.Yet UPMC could get away with this debacle scot-free:</div><blockquote><div class="story_body">Despite the way it occurred, UPMC will probably not be found in violation of any federal guidelines for the failure of the transplant team to review the positive hepatitis C test [or failure of the health IT system to properly transmit it, if that is indeed what occurred - ed.] That's because while current guidelines from the United Network for Organ Sharing, the organization that oversees the nation's transplant centers and could suspend or shut a program down for deficiencies, do cover deceased donor transplants, they do not specifically cover living donor transplants, except in a limited way. Emily Blumberg, an infectious disease specialist at the University of Pennsylvania, said that it is because live donations are still a relatively new medical advancement compared to cadaver donations. "What has happened is that live donations in the United States have really taken off in the last decade, and there's only been a push to standardize live donation processes recently," said Dr. Blumberg. </div></blockquote>In other words you're supposed to test dead people and their organs for disease before transplanting them, but live people get a pass? This is the height of absurdity. <blockquote>One of the factors driving the push to finally address guidelines for living donor transplants is the rapid emergence of so-called paired kidney donation networks. In the networks, a willing living donor, who isn't a match to a friend or relative who needs a kidney, gives their kidney to someone else in the network. That recipient then has a friend or relative give a kidney to someone else, and so on. Over the last five years, the rise of such networks have allowed hundreds of people to get kidney transplants from people they previously did not know, including a chain involving 32 donors and recipients -- 16 of whom got new kidneys -- that UPMC was part of earlier this year. "Everybody is [testing for viruses] but it would be helpful if we could all be doing it the same way -- especially with paired donation networks," said Dr. Blumberg, who also chairs UNOS's disease transmission advisory committee. </blockquote> This seems a smokescreen for this error. Missing a positive hepatitis C test has nothing to do in my mind with "everyone testing for viruses in the same way." The issue is being aware of the results. <blockquote>Through that committee, UNOS is now beginning to craft new guidelines that are specific to live donation transplants. A conference in July in Baltimore that Dr. Blumberg is helping to organize will act as a public forum on the proposed new guidelines that will address everything from which viruses should be tested for, to which tests should be used, to how the results are communicated and other issues.</blockquote> Non-communication of results will surely be forbidden. <blockquote>The guidelines that do exist now don't spell out how information about a test is to be conveyed and confirmed by people on the transplant team, which are protocols that are left to each individual hospital to establish.</blockquote> This is entirely absurd. "Protocols" are needed to check the most fundamental of tests in a mission critical medical area? Why does this process have to be "spelled out?" In other areas such as blood transfusion, isn't the precess of someone actually looking at test results very straightforward? I did it as a medical student.... <blockquote>Those same guidelines -- which were written for the more common deceased donor transplants -- also don't explicitly require testing of living donor organs for viruses like hepatitis C, though, as a rule, transplant centers like UPMC do so anyway. "I can tell you every transplant center in the country already screens donors for things like hepatitis C or other infections that would affect our use of that organ," Dr. Blumberg said. </blockquote>That's great, as long as the information doesn't end up in '/dev/null', a.k.a. the bit bucket. The rest of the Gazette article discusses the obvious regarding a simple issue of testing and reporting prior to sticking an organ into someone else's body. I believe if this incident was indeed related to a computer error: <ul><li>UPMC needs to reveal this publicly ASAP per <a href="http://jama.ama-assn.org/cgi/content/extract/302/4/382">Joint Commission Safety Standards</a>, as similar flaws could affect other medical centers (such flaws that cause intermittent data erasure are known to exist; see Dr. Jon Patrick's study <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">here</a> on a Cerner system, for example.)</li></ul><ul><li>Repeats of episodes like this could reflect criminal negligence (not of clinicians, but of the administration for installing faulty medical devices), or may already represent criminal negligence if the health IT systems in use were known to have bugs causing intermittent data loss.</li></ul>-- SS Addendum May 25, 2011: It occurs to me that hepatitis is a rather routine type of lab test. Everyone who looked at the electronic chart, usually a cornucopia of people in an academic medical center, had opportunity to review tests like that. They range from medical students, to interns and residents, to fellows to attendings, nurses, and other allied health professionals, not just a few specific people on the transplant team. In my mind the most likely explanation for so many people missing such a crucial piece of data is that it was simply not there. -- SS Addendum May 27, 2011: A reader reminded me of my 2009 post "<a href="http://hcrenewal.blogspot.com/2009/04/upmc-pioneers-in-health-it-or-pioneers.html">UPMC as Proving Ground for IT Tests On Children: Pioneers in Health IT, or Pioneers in Ignoring the Past</a>?", where UPMC made claims it was a "proving ground" for experimental health IT development. -- SS

Transplant Team at UPMC Missed Hepatitis Result - Suspicious for Health IT Failure?

A story suspicious for EMR malfunction appeared in the Pittsburgh Post Gazette: Transplant team missed hepatitis result Kidney donor, recip...

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Quest Diagnostics Settles, Version 2

And the latest entrant in the parade of legal settlements is a medical laboratory company, as <a href="http://articles.latimes.com/2011/may/20/business/la-fi-quest-settlement-20110520">reported</a> by the Los Angeles Times: <blockquote>Quest Diagnostics Inc., the biggest provider of medical lab services in California, has agreed to pay $241 million to settle a whistle-blower's lawsuit that accused it of overcharging the state Medi-Cal program.</blockquote> This was not only about financial misbehavior, but about paying physicians and health care providers to influence their decisions in favor of the payer, but not necessarily their patients: <blockquote>The lawsuit also alleged that the Madison, N.J., company paid illegal kickbacks to doctors, hospitals and clinics that sent patients their way.</blockquote> As usual, despite the allegations above, the company issued the de rigeur denials: <blockquote>Quest acknowledged the settlement in a statement but denied any wrongdoing. 'Our laboratory testing services for Medi-Cal were priced appropriately, and we deny all allegations in the complaint,' said Michael E. Prevoznik, Quest's senior vice president and general counsel. Quest said it settled 'to put the lawsuit behind us.'</blockquote> Of course, lawyers are expensive. But it is awfully hard to believe a trial would cost more than a small fraction of the amount paid out. So it is very hard to believe that the company paid nearly a quarter of a billion dollars just to avoid the expense and inconvenience of going to court. That the company paid so much to avoid contesting an action that alleged such kickbacks seems at odds with the company's earnest <a href="http://www.questdiagnostics.com/brand/company/questcares/corporate_responsibility.html">"corporate citizenship" statement</a>: <blockquote>Honesty and integrity are the cornerstones of our corporate philosophy. We strive to do the right thing when it comes to caring for our patients, dealing with our business partners and working alongside our fellow employees. We never forget that we’re in the business of caring for people. Every day, we work hard to earn your trust and maintain our reputation for providing unsurpassed diagnostic insights and innovation. </blockquote> What does not contesting allegations about kickbacks to doctors and hospitals have to do with "honesty and integrity," doing "the right thing," or "earn[ing] your trust?" That would be a particularly good question to put to certain members of the <a href="http://phx.corporate-ir.net/phoenix.zhtml?c=82068&p=irol-govboard">Quest Diagnostics board of directors </a>who have roles that ought to suggest they might have a certain level of discomfort with not  contesting allegations of giving kickbacks to physicians and hospitals, e.g.: <ul><li>John C Baldwin MD, the surgeon who is "Senior Advisor for Health Affairs to the Texas Tech University System," </li><li>Jenne K. Britell, Ph.D.,"a trustee of the Fox Chase Cancer Center," </li><li>Rosanne Haggerty, "the founder and President of Common Ground Community, a not-for-profit organization that develops strategies to end homelessness," </li><li>Surya N. Mohapatra, Ph.D., CEO and Chairman of the Board, also "a Trustee of Rockefeller University," and </li><li>Gail Wilensky Ph.D., a well-known health policy expert who has been vocal in health care reform discussions, and is "a Senior Fellow at Project HOPE."</li></ul>Of course, as the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">parade of legal settlements</a> continues, it has been markedly unusual for any of the board members of the organizations involved, no matter how distinguished their credentials in the health arena, to have anything to say about them. Also, as is tediously usual in such cases, I could find nothing to suggest any negative consequences for any individual who might have authorized, directed, or implemented the bad behavior, and specifically, that might have had anything to do with the kickbacks that were alleged to have occurred. The continuing march of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> now seems to have included most of the previously well reputed commercial health care firms in the US. The length of this march is an indication of how pervasive is bad behavior by such health care organizations, especially when the marchers were accused of behavior that appeared clinically, not just financially unethical. I assert again that pervasive bad behavior by large health care organizations has got to be a major cause of our ongoing health care dysfunction. As we have said repeatedly, even large monetary penalties paid by corporations are unlikely to do anything other than somewhat increase their costs of doing business.  (Note that this is the second settlement by Quest Diagnostics we have discussed on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>.  The first settlement, for over $300 million, <a href="http://hcrenewal.blogspot.com/2009/04/quest-diagnostics-settles.html">was in 2009</a> and involved felony misbranding charges by a Quest subsidiary.  In that case too no actual persons suffered any negative consequences.) So, to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable.    As long as they are not, expect the bad behavior to continue.  (We said that in 2009 about the first Quest Diagnostics settlement, and now it seems to have been a good prediction.  You heard it here first on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>.)

Quest Diagnostics Settles, Version 2

And the latest entrant in the parade of legal settlements is a medical laboratory company, as reported by the Los Angeles Times: Quest Diag...

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Key lesson from the NPfIT - The Tony Collins Blog

ComputerWorldUK.com <a href="http://blogs.computerworlduk.com/the-tony-collins-blog/2011/05/the-national-programme-of-failed-it-in-the-nhs/"></a><blockquote><a href="http://blogs.computerworlduk.com/the-tony-collins-blog/2011/05/the-national-programme-of-failed-it-in-the-nhs/">Key lesson from the NPfIT - The Tony Collins Blog</a> Listening to critics is critical to the success of big projects. But has this lesson been learnt? Published 07:56, 20 May 11 A US doctor Scot Silverstein, who has an expertise in clinical IT design, says of the NAO report on the NPfIT that the initials should stand for: "National Programme of Failed IT.”He says on the blog <a href="http://hcrenewal.blogspot.com/2011/05/national-programme-of-failed-it-in-uk.html">Health Care Renewal</a>:"Perhaps the NPfIT (National Programme for IT in the NHS) should be renamed the "National Programme of Failed IT in the NHS." No new acronym will be needed.</blockquote>Read the entire ComputerWorldUK piece by Tony Collins. Some of the excuses and rationalizations described during this programme are simply stunning.This idea, though, I find fascinating:<blockquote>One of the lessons that emerges from disastrous business decisions, as recorded on the excellent BBC2 series "<a href="http://www3.open.ac.uk/media/fullstory.aspx?id=21194">Business Nightmares"</a> with Evan Davis, is that expensive new ideas should be tested, and repeatedly tested, by the harshest critics of those ideas. </blockquote>-- SS

Key lesson from the NPfIT - The Tony Collins Blog

ComputerWorldUK .com Key lesson from the NPfIT - The Tony Collins Blog Listening to critics is critical to the success of big projects. But ...

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"Running Away from the Problem" of Health Care Corruption

Despite its likely importance, the very concept of health care corruption remains highly anechoic.  Last week's Lancet, however, actually mentioned it, albeit indirectly and ironically.(1)  The context was Richard Horton's discussion of a press conference on the final report of the UN Secretary-General's Commission on Information and Accountability for Women's and Children's Health. It appears that accountability, which we consistently advocate, was central to the report: <blockquote>The big conclusion is that a huge accountability gap exists - we have incredibly weak mechanisms to make sure that the billions spent on women's and children's health are delivering the results we expect.</blockquote> The report listed "ten commandments of women's and children's health, [which] aim to fill that accountability gap." While the press conference went on, something unusual happened, as Richard Horton discussed somewhat ironically: <blockquote>In truth, meetings such as these may not always produce the most exciting moments in the history of health (but this one did). Yet they can produce episodes of raw undiplomatic honesty which make the long waits and dull protocol worthwhile. [Secretary General of the International Telecommunication Union Hamadoun] Toure has a reputation for being blunt and outspoken. He surpassed himself last week. At the end of the first day, he suddenly began a riff of denunciation that left us all speechless. 'There is more corruption in the G8 countries than in the whole of Africa,' he declared with conviction. 'We are just running away from the problem.'</blockquote> There you have it, one of the few mentions of health care corruption in the medical and health care literature, and one of the very few mentions of health care corruption afflicting developed, not just developing countries. Interestingly, Horton then documented an immediate attempt by some very important people in global health care to paper over the unpleasantness raised by Toure's honest assessment: <blockquote>President [Jakaya] Kidwete [of Tanzania] and Margaret Chan, WHO's Director-General, did well to pull their colleague back from the brink of professional suicide. 'This is a partnership effort,' affirmed Kikwete. He wanted no one think the generosity of international donors did not count. 'They are critical for development,' he said. Dr Chan stepped in to assert that 'development money works.'</blockquote> So there you have it again. Stating that health care corruption is an important problem in developed countries is "professional suicide," even for the Secretary General of the International Telecommunications Union. Yet Dr Horton, was willing to go a little further, maybe risking his own "professional suicide," <blockquote>The President and DG are right. But Toure had a point too. And most of us in the room knew it.</blockquote> We have noted before that health care corruption is the great unmentionable.  The corruption that is mentioned is that afflicting developing countries.  Hardly anyone seems willing to say that health care corruption is just as big a problem in developed countries, including those that provide most of the funding for health care development in the developing countries.  As we see above, we now have an acknowledgement in one of the most influential medical journals that mentioning health care corruption in the developed world is "professional suicide."  That is the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a> writ large.  Left unsaid is why this is so.  Presumably, the reason is that corruption is wide-spread.  The corrupt have made a lot of money and become very powerful.  So it is very unwise to offend them.  That, of course, just lets corruption flourish, and so health care gets increasingly expensive, inaccessible, and bad for patients and the public. If we really want to improve health care in our own countries, and to improve global health, we will all have to be as brave as Mr Toure. See below for a repeat of our <a href="http://hcrenewal.blogspot.com/2011/02/after-publicity-about-losses-from.html">previous summary</a> of the issue of health care corruption. +++ Many people more distinguished than yours truly have been warning about health care corruption for years. In particular, in 2006, <a href="http://www.transparency.org/publications/gcr/gcr_2006">Transparency International's Global Corruption Report</a> asserted in its executive summary, "the scale of corruption is vast in both rich and poor countries." It also noted how diverse is health care corruption: <blockquote>In the health sphere corruption encompasses bribery of regulators and medical professionals, manipulation of information on drug trials, the diversion of medicines and supplies, corruption in procurement, and overbilling of insurance companies. It is not limited to abuse by public officials, because society frequently entrusts private actors in health care with important public roles. When hospital administrators, insurers, physicians or pharmaceutical company executives dishonestly enrich themselves, they are not formally abusing a public office, but they are abusing entrusted power and stealing precious resources needed to improve health.</blockquote>It further stated how serious the consequences of corruption may be: <blockquote>Corruption deprives people of access to health care and can lead to the wrong treatments being administered. Corruption in the pharmaceutical chain can prove deadly.... The poor are disproportionately affected by corruption in the health sector, as they are less able to afford small bribes for health services that are supposed to be free, or to pay for private alternatives where corruption has depleted public health services. Corruption affects health policy and spending priorities.</blockquote>On this blog, our limited resources make us focus mainly on the US, and sometimes other English-speaking countries. Yet we now have in our archives some amazing stories that document various forms of corruption, including numerous allegations of corporate misbehavior ending in <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a>, and examples of outright <a href="http://hcrenewal.blogspot.com/search/label/fraud">fraud</a>, <a href="http://hcrenewal.blogspot.com/search/label/bribery">bribery</a>, <a href="http://hcrenewal.blogspot.com/search/label/kickbacks">kickbacks</a> and other <a href="http://hcrenewal.blogspot.com/search/label/crime">crimes</a>. Also, as we have noted before, the US Institute of Medicine has <a href="http://www.iom.edu/Reports/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice.aspx">defined conflicts of interest</a> <blockquote>Conflicts of interest are defined as circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest.</blockquote>Given that Transparency International's definition of corruption is <blockquote>abuse of entrusted power for private gain</blockquote>One can easily argue that in health care, conflicts of interest defined as above create risks of abuse of power by health care professionals influenced by the private gains provided by their secondary interests. On Health Care Renewal, we have provided a massive set of examples of <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">individual</a> and <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">institutional</a> conflicts of interest. There is evidence that about two-thirds of medical academics(2) and academic leaders(3) have significant conflicts of interest. The huge prevalence of conflicts suggests the enormous risk of major corruption. So what we all should be shocked, shocked about is how little has been done to fight health care corruption, whether <a href="http://hcrenewal.blogspot.com/2011/02/after-publicity-about-losses-from.html">in Mozambiqu</a>e or the US. However, one can find very few significant efforts to discuss, teach about, or research ways to fight corruption, or to promote accountability, integrity, transparency, honesty and ethics by academic health care institutions. (See <a href="http://hcrenewal.blogspot.com/2010/11/who-you-gonna-call-how-should-young.html">this post </a>for how difficult it was to find academic institutions' initiatives to resist conflicts of interest.) One can count the conferences, meetings, symposia, and courses on such topics on one's fingers. When I last looked, I could count only a <a href="http://sph.bu.edu/index.php?option=com_sphdir&id=239&Itemid=617263&INDEX=771">single course </a>on fighting corruption at any US medical or public health school (at Boston University, by Prof Taryn Vian). Given the scope of corruption, we should be shocked, shocked at how anechoic it is, and how our respected health care institutions, particularly academic institutions and health care charities have ignored the problem. Given the scope of corruption, we should be shocked, shocked at how anechoic it is, and how our respected health care institutions, particularly academic institutions and health care charities have ignored the problem. Of course, one reason we started Health Care Renewal was to make these issues less anechoic. So hear we go again. PS - If anyone in our vast audience does know about any additional anti-corruption or conflict of interest, or pro-accountability, integrity, transparency, honesty and ethics initiatives, courses, meetings relevant to health care, please let me know and I will do my best to disseminate the information. References 1.  Horton R. Offline: ten commandments, G8 corruption, and OBL. Lancet 2011; 377: 1638.  Link <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2811%2960653-3/fulltext">here</a>. 2. Campbell EG, Gruen RL, Mountford J et al. A national survey of physician–industry relationships. N Engl J Med 2007; 356:1742-1750. Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMsa064508">here</a>. 3. Campbell EG, Weissman JS, Ehringhaus S et al. Institutional academic-industry relationships. JAMA 2007; 298: 1779-1786. Link <a href="http://jama.ama-assn.org/cgi/content/full/298/15/1779">here</a>.

"Running Away from the Problem" of Health Care Corruption

Despite its likely importance, the very concept of health care corruption remains highly anechoic. Last week's Lancet, however, actuall...

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A Severance Package to an Un-Severed CEO - A Manifestation of "CEO Disease?"

The latest jaw-dropping story about executive compensation in health care has been unfolding in California, but at least now I have a diagnosis for this syndrome.  A Generous Retirement Package, Paid Before Retirement In April, the Los Angeles Times <a href="http://articles.latimes.com/2011/apr/28/local/la-me-pensions-20110428">reported</a> about the generous retirement package given to an outgoing public hospital district CEO in California: <blockquote>When he turned 65 two years ago, Samuel Downing received a $3-million retirement payment from a public hospital district in Salinas, Calif., where he serves as president and chief executive. But Downing continued working at his $668,000-a-year job for another two years, and after he retires this week, he will receive another payment of nearly $900,000. That comes on top of his regular pension of $150,000 a year.</blockquote> Note that not only was this pension package large in an absolute sense, but it was provided before the CEO actually retired. This compensation was clearly out of the ordinary: <blockquote>The payments amount to one of the more generous pension packages granted to a public official in California and come amid growing debate about 'supplemental' pensions that some officials receive on top of their basic retirement benefits. Though Downing's case is extreme, it follows the disclosure of extra pension benefits received by employees in municipalities including Bell and San Diego. Earlier this year, a state watchdog group called for stricter pension rules, saying California's retirement plans are 'dangerously underfunded, the result of overly generous benefit promises, wishful thinking and an unwillingness to plan prudently.' Seventy percent of Californians support a cap on pensions for current and future government workers, according to a recent Los Angeles Times/USC Poll.</blockquote> Furthermore, there was a disconnect between the size of the pension payments and the hospital district's financial situation: <blockquote>But the $3.9 million in supplemental retirement payments to Downing has come during a period of cutbacks at the hospital, including the reduction of 600 positions through layoffs and attrition. Hospital representatives said the cuts were mainly a response to recent economic conditions. The hospital has faced declining revenues and patient admissions and has been burdened by construction costs of a state-mandated retrofit project, they said.</blockquote> Hospital district apologists had the usual excuses: the pensions reflected the market, and the CEO is brilliant: <blockquote>Officials at the Salinas Valley Memorial Healthcare System defended the payouts, saying they need to pay private-sector-level benefits to retain top talent. They described Downing as a gifted and experienced administrator. 'I think I've earned it,' Downing said in an interview. 'I've stayed here out of my commitment to try to build a great hospital.... I worked for this institution and gave them my heart and soul.'</blockquote> As usual, left unsaid were how the CEO's "brilliance" was justified, other than by his own assertion, and why the CEO deserved so much credit for the performance of a hospital system that employed many other people. A Generous Severance Package, Paid to Someone Still Employed  Yesterday, it turned out that there was even more to Mr Downing's compensation. As again <a href="http://www.latimes.com/news/local/la-me-05-18-pension-20110519,0,4260805.story">reported</a> by the Los Angeles Times, <blockquote>A Salinas public hospital district, already under fire for granting its outgoing chief executive $3.9 million in retirement payments, also gave him nearly $1 million as part of an unusual severance agreement, according to records obtained by The Times. The payment fattened what was already considered one of the more generous public pensions ever given in California. Its disclosure prompted the state Assembly earlier this month to order an audit of the hospital district's finances. The Salinas Valley Memorial Healthcare System board gave Samuel Downing a cash payment of $947,594 in 2008, according to a hospital report on his compensation. The money came from a special severance fund set aside for when Downing ended his employment with the agency. But the board decided to award him the money while he was still CEO. By the time Downing retired last month, he had received a series of supplemental retirement benefits totaling $3.9 million, in addition to the severance payment. He will also be paid a regular pension of $150,000 a year. He earned about $670,000 in base salary during his final years of employment, along with other benefits such as a car allowance and paid time off.</blockquote> The details of how the CEO became entitled to this severance agreement, and how a severance payment was made to someone whose employment was not severed was sketchy: <blockquote>Salinas Valley officials said the severance payment stemmed from a handshake agreement in the 1980s between Downing and a previous president of the board of directors. In 2000, the hospital's board agreed to a contract in which Downing would be paid 18 months' salary upon the end of his employment. In 2008, the board voted to give Downing that money, which totaled nearly $948,000. It's unclear exactly why the board of directors decided to grant Downing the cash-out. The five board members, who are elected at-large by residents of the hospital district, didn't return calls seeking comment.</blockquote> Mr Downing, of course, once again asserted he deserved the money: <blockquote>Downing said he felt he deserved the pay after a long and successful career at the hospital, where he started in 1972. 'It sounds like a lot of money to everybody … but I know what the industry is and I know the board did an independent study,' he said. 'The board did an excellent job. They made sure we had competitive salaries.'</blockquote> Once again, a hospital district public relations person went to bat for him, by blaming previous board members: <blockquote>A hospital district spokeswoman released a statement Wednesday saying the current hospital directors were 'obligated by a previous board' to pay out Downing's severance.</blockquote> At least no one so far is claiming that this part of Mr Downing's compensation was determined by the almighty "market." In fact, <blockquote>But several outside experts said it is unusual for an entity to award severance to someone who remains an employee. Typically, they said, severance is promised to employees only in the event that they are pushed out of their jobs. Downing's severance was also atypical because he was entitled to it even if he retired of his own accord rather than being forced to leave. 'It's absolutely outside of the industry standard to pay a severance upon retirement,' said Jeff Christenson, a compensation consultant at the firm Integrated Healthcare Strategies. 'The theory of severance pay is to protect an executive or an employee from an unforeseen termination.'</blockquote> And of course the severance was not even paid on retirement, but paid while Mr Downing was still working. Summary - A Manifestation of "CEO Disease?" Once again we see how top health care leaders are different from you and me.  Despite the fact that executives are paid employees, they seem to be entitled to special treatment far beyond that afforded other employees.  While the modern treatment of health care executives as minor deities seemed to start in the private health care sector, it seems to be extending even into government. It turns out, over 20 years ago, the BusinessWeek cover story was entitled "<a href="http://www.businessweek.com/archives/1991/b320639.arc.htm">CEO Disease</a>."  It summarized the pathology that now seems to be the major cause of health care system dysfunction.  Yet the warning still goes largely unheeded: <blockquote>Pampered, protected, and perked, the American CEO can know every indulgence. The executive who finally reaches the top of a major corporation enters an exclusive fraternity. The CEO's judgment and presence are eagerly sought by other captains of industry and policymakers. CEOs zip around the world in private jets and cash the heftiest personal paychecks in industry. They take home 85 times what the average blue-collar worker makes, unlike their counterparts in Japan, where the ratio is closer to 10 to 1 (page 60). [That was in 1991.  For larger US companies, the ratio was 343 in 2010.  See <a href="http://money.cnn.com/2011/04/19/news/economy/ceo_pay/index.htm">this link</a>. -Editor] It is a job that can easily go to one's head--and often does. 'Too many people treat CEOs as some kind of exalted, omnipotent leader,' says John Sculley, CEO of Apple Computer Inc. 'The real danger is that you start believing that stuff.' Sculley took a sabbatical in 1988 as a way of "reacquainting myself with the fact that I'm a mere mortal." Many chief executives come to believe that they are much more than that. The perquisites and deferences create a protective cocoon--if not a full-fledged fantasy world--for the chieftains of some of the nation's largest companies. 'Many CEOs take on a level of self-importance that goes way beyond reality,' says Douglas D. Danforth, former CEO of Westinghouse Electric Corp. and now a director at several large corporations. 'They view the company as their own . . . . Some people's personalities change completely. If you're not careful, you can be seduced.' Call it CEO Disease. The symptoms are all too familiar: The boss doesn't seem to understand the business anymore. Decisions come slowly, only to be abruptly changed. He (there are only two women CEOs in the BUSINESS WEEK 1000) feels he can do no wrong and refuses to concede any mistake. He begins to surround himself with sycophants in senior management and on the board. TELLTALE SIGNS. Increasingly, the boss may seem out of touch--spending too much time away from the job, playing the role of statesman for the sake of personal recognition. He may even compete with industry counterparts over how much money he makes, how big the headquarters building is, or how many corporate jets are parked on the landing strip. And when it's time to leave the job, the boss just hangs on, often by undermining potential successors.</blockquote> In 1991, the BusinessWeek article suggested some ways to prevent CEO disease. In 20 years, these suggestions have been largely ignored in health care corporations, and in the larger health care system and the surrounding economy: <blockquote>A few fairly simple reforms would go a long way toward preventing many cases of CEO Disease, at least in its most virulent form. One obvious answer is to disperse decision-making. An advantage of this approach is that it focuses attention on a group of executives, not just the CEO. The prevalence of the problem also makes an overwhelming case for more involvement at the board level. To be effective, boards must be composed of a sizable percentage of outside directors who have the time to learn enough about a company and its management to make informed decisions about its leadership. If the boss isn't receptive and problems mount, a responsible director has no choice but to press for change. On four separate occasions since he started serving on boards, Jewel's Perkins says, 'I've sat down with the CEO and said: `In my judgment, you've made the contribution you can to this organization.' Three CEOs took early retirement. Ultimately, the power to prevent, and if necessary, cure CEO Disease rests with the shareholders. They have the right, and the duty, to insist on a board of competent and aggressive outsiders. At least, they do in theory. In reality, shareholders are often either passive, indifferent, or only invested in the stock on a short-term basis.</blockquote> CEO disease would seem to be an explanation for why a public hospital district gave an outlandish retirement package and a severance payment to a CEO who was still in office. CEO disease would describe much of the bad management we have described on this blog. So, as I have said before,.... health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. On the other hand, those who authorize, direct and implement bad behavior ought to suffer negative consequences sufficient to deter future bad behavior. If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses. We need to launch a crash program to prevent CEO disease and cure existing cases, before it kills off our health care system.

A Severance Package to an Un-Severed CEO - A Manifestation of "CEO Disease?"

The latest jaw-dropping story about executive compensation in health care has been unfolding in California, but at least now I have a diagno...

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NPfIT: National Programme of Failed IT in the NHS

I have a suggestion for the Queen: Perhaps the NPfIT (National Programme for IT in the NHS) should be renamed the "National Programme of Failed IT in the NHS." No new acronym will be needed. For this pleasure, the UK has spent upwards of £13 billion. Of course, we as the progeny of the UK are going down the same path, surely soon to have a "National Program for Failed IT in the US." Ours will be a bit more expensive, unfortunately. Excerpts from the US and UK press (read the entire pieces at the links): <a href="http://online.wsj.com/article/SB10001424052748703421204576330691233267966.html"> </a> <blockquote style="font-family:arial;"><a style="font-weight: bold;" href="http://online.wsj.com/article/SB10001424052748703421204576330691233267966.html">http://online.wsj.com/article/SB10001424052748703421204576330691233267966.html</a> Wall Street Journal Auditor Blasts UK HIT BY STEN STOVALL LONDON The billions of pounds spent so far on England's much-delayed electronic patient record system within the National Health Service have been poorly used and the project urgently needs to be reassessed to ensure taxpayers get value for their money, the U.K.'s National Audit Office said Wednesday. A report released by the independent body concludes that the £2.7 billion spent on the records systems so far "does not represent value for money." <a href="http://www.computerworlduk.com/news/public-sector/3280340/official-failed-nhs-national-it-programme-has-no-chance-of-delivering-value-for-money/"> </a><a style="font-weight: bold;" href="http://www.dailymail.co.uk/health/article-1388224/NHS-IT-project-cost-billions-delivering-ANY-benefits.html">http://www.dailymail.co.uk/health/article-1388224/NHS-IT-project-cost-billions-delivering-ANY-benefits.html</a> Dailymail.co.uk NHS IT system 'has cost billions without delivering ANY benefits' By Sophie Borland 18th May 2011 Health Minister damns project as 'expensive farce' The NHS’ controversial project to computerise all patient records has cost billions of pounds without delivering any benefits, according to a damning report. It warns the project is running years behind schedule and will probably never happen. The £11 billion scheme, launched under Labour in 2002, was meant to create a central computer database of all patient records which could be easily be accessed by GPs and hospitals. But from the outset it has been hit with technical glitches and arguments between the companies installing the systems. The scheme has also been heavily criticised by leading doctors and privacy campaigners who warned patients’ personal details would be vulnerable if stored on a database that could be easily accessed by thousands of NHS staff. ... The project was meant to be completed last year but the report warned that it was unlikely to be finished even by 2016, when the contract with one of the main firms installing the system expires. So far only a few hospitals across the country have installed the new system – and there have been widespread problems. Doctors have said it is too slow to use during busy clinics and other staff have reported the system suddenly crashing. Ministers last night described the project as an “expensive farce” and demanded it was scrapped immediately. <a href="http://www.computerworlduk.com/news/public-sector/3280340/official-failed-nhs-national-it-programme-has-no-chance-of-delivering-value-for-money/">http://www.computerworlduk.com/news/public-sector/3280340/official-failed-nhs-national-it-programme-has-no-chance-of-delivering-value-for-money/</a> Computerworld UK Official: Failed NHS National IT programme has no chance of delivering value for money Time to turn off the life support machine? By Leo King Published 00:02, 18 May 11 The NHS National Programme for IT, which is now budgeted at £11.4 billion, has no chance of delivering value for money and has failed on all of its crucial elements. That is the verdict of a sharp report, compiled by the National Audit Office, that the prime minister has publicly insisted on assessing before any more deals are signed with suppliers. The report will be followed by Public Accounts Committee hearings and a Treasury report, which will also precede any signature. National audit of the £11.4bn, 10-year UK program to automate all NHS patient records concludes "the project has not been value for money for the Dept of Health." <a style="font-weight: bold;" href="http://www.bbc.co.uk/news/health-13430375">http://www.bbc.co.uk/news/health-13430375</a> BBC News £7bn NHS electronic records 'achieving little' for patients By Nick Triggle Health correspondent Patients are getting "precious little" from the NHS electronic care records system in England, a watchdog says. The £7bn system to replace paper files is falling further behind schedule and in places where it has been introduced it is not working as it should. The National Audit Office also said some patients would not even get one as large chunks of the NHS had pulled out. In conclusion, the NAO said the system was not providing value for money - something the government rejected. Electronic care records are the key part of the overall £11.4bn NHS IT project. The scheme was launched in 2002 with the aim of revolutionising the way the health service uses technology and also includes developments such as digital x-rays and fast internet connections. It is the third time the NAO has looked at electronic records - and each time the findings have been more damning. <a style="font-weight: bold;" href="http://www.guardian.co.uk/society/2011/may/18/government-urged-to-abandon-nhs-it-programme">http://www.guardian.co.uk/society/2011/may/18/government-urged-to-abandon-nh</a><a href="http://www.guardian.co.uk/society/2011/may/18/government-urged-to-abandon-nhs-it-programme">s-it-programme</a> The Guardian Government urged to abandon NHS IT programme Polly Curtis, Whitehall correspondent guardian.co.uk, Wednesday 18 May 2011 12.03 BST The government is coming under increasing pressure to abandon plans for a new NHS patient record system after the official spending watchdog said the scheme was very likely to waste another £4.3bn in the next four years. The original aim of the £11.4bn NHS IT programme – to install a patient record database accessible from any point in the NHS in England by 2015 – will fail, the National Audit Office (NAO) warned. The £2.7bn spent so far on the system has not been value for money, the watchdog said, adding it had no confidence that the remaining £4.3bn would be any better spent. The nine-year-old project – the biggest civilian IT scheme attempted – has been in disarray since it missed its first deadlines in 2007. While its ambitions have been downgraded in recent years, the bill from the suppliers has remained largely unchanged, the report said. MPs appealed for the remaining contracts to be abandoned to prevent the £4.3bn from going to waste. It amounts to more than one-fifth of the £20bn efficiencies the NHS is attempting to achieve. </blockquote> I think it fair to say the UK has been massively fleeced and abused by its suppliers, consultants and health IT pundits. The people of the UK have paid for this boondoggle. They should think of it as a form of taxation without representation, an abuse of their rights. Perhaps they can learn a valuable lesson from this document: <blockquote style="font-family:arial;"><a href="http://www.ushistory.org/declaration/document/">The Declaration of Independence of the United States</a></blockquote> Truth brings freedom. -- SS

NPfIT: National Programme of Failed IT in the NHS

I have a suggestion for the Queen: Perhaps the NPfIT (National Programme for IT in the NHS) should be renamed the " National Programme...

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More Medical Societies Supported by Industry

There were several new reports about the extent that medical societies are supported by industry.  Last week we <a href="http://hcrenewal.blogspot.com/2011/05/has-heart-rhythm-society-become-more.html">asked</a> whether the extent of the industrial support provided the Heart Rhythm Society made that organization appear to be more of a marketing firm than a professional society.  Society for Cardiac Angiography and Interventions (SCAI) ProPublica <a href="http://www.propublica.org/article/cardiac-society-draws-bulk-of-funding-from-stent-makers">reported</a> last week: <blockquote>The Society for Cardiac Angiography and Interventions (SCAI) received 57 percent of its revenues in 2009 from medical device and pharmaceutical makers, according to financial information on the group's website. Industry contributions to the society's budget covered $4.7 million of the $8.2 million it received that year. The group's biggest funders are the companies with the biggest share of the stent market: Cordis Corp. (a subsidiary of Johnson & Johnson), Boston Scientific, Abbott Laboratories and Medtronic. </blockquote>So here is another medical society that gets more money from pharmaceutical, biotechnology and device companies than it does from its members. The SCAI does not make obvious any relationships among its board members and officers and industry and does make publicly accessible its CEO's compensation or its recent 990 forms (see its web-site <a href="http://www.scai.org/default.aspx">here</a>). National Lipid Association (NLA) The CardioBrief blog discussed the somewhat more convoluted case of the sources of support of the National Lipid Association. First blogger Larry Husten examined the role of industry support for the association's "clinical guidance papers" on familial hypercholesterolemia  (FH). These papers recommended extremely aggressive screening for high cholesterol, that is, starting for 9 year old children, and 2 year olds whose families' had histories of elevated cholesterol and coronary disease. The conference that came up with these ideas was supported by drug companies, per the <a href="http://cardiobrief.org/2011/05/17/part-1-the-national-lipid-association-and-the-fh-guidelines/">first blog post </a>in a three-part series: <blockquote>The January 2011 NLA familial hypercholesterolemia recommendations conference was supported by unrestricted grant funding from the following companies: Abbott Laboratories, Aegerion Pharmaceuticals, Daiichi Sankyo, Genzyme, Kaneka Pharma America LLC, and Merck & Co.</blockquote> Also, <blockquote>Each of these companies would benefit from increased screening and treatment of FH and some, such as Keneka, Aegerion, and Genzyme have a huge portion of their future invested in FH.</blockquote> Furthermore, <blockquote>The executive summary of the papers includes disclosures from all of the authors, and all the authors list industry ties, and all but two of the authors disclose multiple relationships with industry (see below). Nearly all had ties with the companies that sponsored the conference. In an interview, [chair of the expert panel Dr Anne] Goldberg, told me that 'we believe in transparency' but that, unlike organizations like the ACC and the AHA, 'we have not taken people off of committees because of any ties with industry.' </blockquote> A <a href="http://cardiobrief.org/2011/05/17/part-2-the-national-lipid-association-and-industry/">second blog post </a>noted that a brochure on FH published by the NLA was supported by a drug company (Genzyme) and that: <blockquote>The NLA offers a multitude of CME programs, nearly all of which are  commercially supported by the pharmaceutical industry. Often the content of the programs are closely tied to the interests of the sponsor. For instance, the program on 'Lipid-Altering Drug Pharmacology and Safety' is supported by Abbott, Merck/Schering-Plough, and Reliant, all of whom manufacture popular lipid drugs.</blockquote> However, in pursuit of the "transparency" promised above, Mr Husten was not able to get a clear idea of the total amount of industry support supplied to the NLA: <blockquote>the NLA does not provide a detailed account of its revenue from industry, so it is impossible to say with certainty precisely how reliant it is upon industry support.</blockquote> Note that the association's <a href="http://www.lipid.org/pages/2010Tax.pdf">2010 990 form </a>listed revenues totaling $3,657,060, of which $1,106,091 came from meeting registration, and $216,356 from dues.  So this society received about 36% of its revenue from these traditional sources, while it received 37% from contributions and grants ($1,246,242) plus $116,750 in exhibitor fees.  (Other sources of revenue were less easy to classify.)  This suggests that the NLA does receive substantial revenue from industry. The NLA did not list amongst its disclosures whether its board members and officers had their own financial relationships with industry. Furthermore, the NLA seems particularly opaque about its hired executives and how much they are paid. Its 2010 990 form did not name its highest-compensated employees, nor list their compensation. Although it noted that its management was "delegated" to Compass Management & Consulting, it did not state the amount paid to Compass,  or the compensation given to any Compass employees who are effectively the NLA's highest-paid employees, nor did it list Compass as one of its most highly-paid independent contractors. Mr Husten discovered an addendum to a 2010 financial report also posted on the web that did state Compass' compensation was $662,640 in "management fees," and $326,378 for "commissions" for "fund-raising, a total of $989,018, equal to 25% of the organization's total expenses of $3,945,688. Summary Here are two more examples of medical societies that receive substantial revenues from companies that make products about which the societies' members may decide to prescribe or implant. In both cases, the societies' seemed to receive at least as much revenue from industry as they did  from members for dues, registration fees, and the like. Although both societies claimed to value transparency, neither disclosed the extent that society leaders and paid managers benefited from the societies' or their own relationships with industry.  So there is reason to be concerned about the extent their volunteer leaders and paid executives may benefit from the soceities' and their own personal relationships with industry. He who pays the piper calls the tune.  So it does not appear unreasonable to ask whether these societies should be regarded as at least as beholden to their industrial funders as to their members and meeting attendees?  So should they be regarded as commercial marketing firms at least as much as professional societies? As we said before, if medical societies have come to resemble marketing firms, is it any wonder that they have not spoken up against the commercialization of health care, even when the result has not been good for physicians' core values? But in that case, why would physicians who care about their patients and their core values want to belong and pay dues to marketing firms? Inquiring minds want to know.... Maybe physicians should only join medical societies that really act like medical societies.

More Medical Societies Supported by Industry

There were several new reports about the extent that medical societies are supported by industry. Last week we asked whether the extent of...

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