tag:blogger.com,1999:blog-7734900509948041772024-03-13T03:32:12.437-07:00macadamyaAnonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.comBlogger504125tag:blogger.com,1999:blog-773490050994804177.post-44299555388008418282012-11-09T07:02:00.002-08:002012-11-09T07:02:30.526-08:00FCDA 1<b><i>Having a Family Dentist Benefits</i></b><br />
<br />
<div style="text-align: justify;">
Most of the family dental practices serve children and adults which are petrified of exploring dentist. Should your children use an anxiety about dental office, it is normal nevertheless make sure the dental office understands in advance. They've got various ways associated with making sure that your children are created comfy. A lot of them will work tough to acquire your son or daughter's safety so they can have far better teeth's health. If your little child requirements other dental operate carried out, aside from the common washing along with tooth fillings, the family dentist can suggest any plastic dentist masters in kids.</div>
<div style="text-align: justify;">
<br /></div>
<div style="text-align: justify;">
After a child has the concern with the dental professional they may find that it is difficult in order to grow out of and they're going to be reluctant to visit the dental office, if they have to. Get them started out along with good oral cleaning along with preventive measures for example scrubbing twice a day as well as flossing regularly. This may ensure that using basic cleaning <a href="http://www.fortcollinsdentalarts.com/teeth-for-life.php">cavity fillings</a> as well as periodontal bacterial infections are eliminated.</div>
<div style="text-align: justify;">
<br /></div>
<div style="text-align: justify;">
It is hard to discover family <a href="http://www.fortcollinsdentalarts.com/">dentists fort collins</a> that is best for your needs as well as your family in every method however you require a family dentist for all of your dentistry. You don't only must discover any dental practice that allows families because patients, nevertheless, you also need to make certain that they recognize your own dental insurance plan. Every dental professional welcomes diverse dental insurance as most of choices upon distinct insurance networks. You can go to your insurance website to decide which dental offices have been in your current network and can help you with family dental care requirements. Split into a new <a href="http://www.fortcollinsdentalarts.com/office-visits.php">family dentist</a> in your circle, and then you can certainly preserve 80% opposed to your 50% coverage for implementing the dentist beyond your community.</div>
Anonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com1tag:blogger.com,1999:blog-773490050994804177.post-79843825012367077792012-08-15T07:07:00.002-07:002012-08-15T07:10:08.308-07:00Universal Health Care<div style="text-align: justify;"><a href="http://3.bp.blogspot.com/-ia5oieRs7_A/UCutSFuV1vI/AAAAAAAAAAg/pNSQO-AGO-A/s1600/Universal%2BHealth%2BCare.png" title="Universal Health Care"><img style="float:left; margin:0 10px 10px 0;cursor:pointer; cursor:hand;width: 320px; height: 320px;" src="http://3.bp.blogspot.com/-ia5oieRs7_A/UCutSFuV1vI/AAAAAAAAAAg/pNSQO-AGO-A/s320/Universal%2BHealth%2BCare.png" alt="Universal Health Care" id="BLOGGER_PHOTO_ID_5776901473318590194" border="0" /></a><a href="http://macadamya.blogspot.com/2012/08/universal-health-care.html"><span style="font-style: italic; font-weight: bold;" title="Universal Health Care">Universal health care</span></a> seems to be a fiercely discussed topic whenever health care change in the United States is actually reviewed.<br /><br />People that maintain that will health is surely an individual responsibility are afraid a process that requires these phones contribute levy dollars to aid guy individuals who don't work responsibly within defending as well as selling their own health. They reason that they want the freedom to decide on their very own physicians along with treatments, and suggest that authorities cannot know very well what is the best for these. These individuals debate that protecting the actual program together with enhancements to provide far better insurance coverage regarding people which continue to be not insured as well as under covered with insurance for his or her health care bills requires may be the merely change that's needed.<br /><br />Those that think health care is surely an particular person appropriate assist a new common health care system with the disagreement that many resident deserves to have the proper care at the right time understanding that a united state's duty is to safeguard it's individuals, frequently even via by themselves.<br /><br />Two other arguments as a result of two opposing ideologies. Both are perfect arguments nevertheless not could possibly be the helping disagreement for working with or doubt <span style="font-style: italic; font-weight: bold;" title="Universal Health Care">universal health care</span>. The issue have to be resolved via an honorable platform.<br /><br />Examination of the particular moral issues inside health care change would require consideration of very different reasons than those already introduced. Moral troubles might target the particular meaningful proper. Discussion would certainly start out with certainly not "What is perfect for me personally?" but "How run out as being a modern society be acting to ensure our measures are generally fairly appropriate?"<br /><br />Integrity refers to determining proper and also completely wrong within precisely how human beings connect with one another. Ethical making decisions with regard to health care reform then would likely demand individuals some thing inside thought on our interactions to each other not really our personal person hobbies.<br /></div><br />Anonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com1tag:blogger.com,1999:blog-773490050994804177.post-86618261700362293812012-08-15T04:17:00.000-07:002012-08-15T07:28:29.484-07:00Contra Costa's $45 million computer health care system endangering lives, nurses sayI am reproducing this story almost without comments - few are needed - merely highlighting familiar themes I have written about at this blog:<br /><br /><blockquote class="tr_bq"><a href="http://www.mercurynews.com/breaking-news/ci_21313174/contra-costas-45-million-computer-health-care-system?refresh=no" target="_blank">Contra Costa's $45 million computer health care system endangering lives, nurses say</a><br /><div class="articleByline" id="articleByline"><span class="author vcard"><span class="fn"></span></span><br /><div class="bylinejb"><span class="author vcard"><span class="fn">By Matthias Gafni</span></span></div><span class="author vcard"><span class="fn"></span></span><br /><div class="bylineaffiliation"><span class="author vcard"><span class="fn">Contra Costa Times (CA)<span class="source-org vcard"><span class="org fn" style="display: none;">mercurynews.com</span></span></span></span></div><span class="author vcard"><span class="fn"></span></span></div><div class="articleDate" id="articleDate">Posted: 08/14/2012 05:30:07 PM PDT</div><div class="articleSecondaryDate" id="articleDate"><span class="updated" style="display: none;" title="2012-08-15T03:55:52Z">August 15, 2012 3:55 AM GMT</span>Updated: 08/14/2012 08:55:52 PM PDT</div><br /></blockquote><div class="entry-content"><div class="articleBody" id="articleBody"><blockquote><div class="articleViewerGroup" id="articleViewerGroup" style="border-bottom: 0px; border-left: 0px; border-right: 0px; border-top: 0px;"><span class="articleEmbeddedViewerBox"></span></div>MARTINEZ -- A new medical computer system used at <a href="http://www.co.contra-costa.ca.us/index.aspx?NID=1927" target="_blank">Contra Costa correctional facilities</a> <b>recommended what could have been a fatal dose of a West County Jail inmate's heart medication last week</b>, an incident that a detention nurse characterized Tuesday as one of <b>many recent close calls</b> with the month-old program.<br /><br />However, the inmate's nurse was familiar with his medical history, recognized the discrepancy and administered the correct amount of Digoxin.<br /><br />It's just one of a number of computer errors that medical staffers say have been <b>endangering inmates, medical staff and sheriff's deputies</b> at the county's five jail facilities since Contra Costa switched on July 1 to EPIC, a computer system that links the correctional facilities to the Contra Costa Regional Medical Center and other county health care operations, two nurses and their union representative told the Contra Costa County Board of Supervisors on Tuesday.<br /><br /><b>"It's dangerous. It's very dangerous,"</b> said an emotional Lee Ann Fagan in a phone interview. The registered nurse works at West County Detention Facility in Richmond. "It's hard to work in an environment that's <b>so frustrating. <i style="color: red;">[Staff frustration increases risk of error and decreases morale, which increases risk of error further - ed.]</i></b> </blockquote><blockquote>"What nurses want is for the EPIC program to <b>go away until it's fixed</b>," she said.<br /><br />The $45 million EPIC system integrates detention medical records with the other arms of the county health system. <b>The system led to 142 nursing complaints in July,</b> said California Nurses Association labor representative Jerry Fillingim, who told supervisors<b> the system does not mesh well with detention health care.</b><br /><br />"I have never in all the time working with the California Nurses Association seen that many (complaints) be filled out," he said. "Each day, these nurses are <b>fearful that they will kill somebody</b> <i style="color: red;"><b>[requiring hypervigilance, which is emotionally and intellectually tiring, increasing risk of error further - ed.]</b></i> ... I think the<b> county tried to rush it, making it comprehensive for everything."</b><br /><br />EPIC has never included corrections in its software and is <b>treating Contra Costa as a</b> <b>"guinea pig," </b>Fillingim said. <i style="color: red;"><b> [Subjects of this experiment don't get the opportunity for informed consent, I add - ed.]</b></i></blockquote><br /><blockquote><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="http://4.bp.blogspot.com/-LFqsl-C6VGA/UCuGMD50e3I/AAAAAAAABBg/0tzqj-zjFLc/s1600/guinea_pig_1-759711.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="213" src="http://4.bp.blogspot.com/-LFqsl-C6VGA/UCuGMD50e3I/AAAAAAAABBg/0tzqj-zjFLc/s320/guinea_pig_1-759711.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Guinea pigs to experiments don't give consent</td></tr></tbody></table><br />'Just a tool'<br /><br />The county wanted to create a uniform electronic health record (EHR), and executives said the tool is important, but not the be-all, end-all.<br /><br />"The EHR is just a tool," said David Runt, chief information officer for the county health services department and who helped phase the system in over 18 months. "It's just one piece of the health care system. The people are the most important part of this process. <b>We can't rely just on a computerized system." <i style="color: red;">[That's certainly a much more temperate position than the usual seller and pundit line that "health IT will transform medicine." It is also an especially good observation when the tool is unreliable! - ed.]</i></b><br /><br />In addition to ongoing training, staff has trained "superusers," safety alerts, diagnostic testing, patient safety daily briefings and other help available. Still, "we are working on resolving many different issues," said Anna Roth, CEO of Contra Costa Regional Medical Center and health centers.<br /><br />"It's the beginning of a long journey that occurs over time," <i style="color: red;"><b>[i.e., an experiment - ed.] </b></i>she said. "I think we can do a better job ... at how we communicate everything we're doing to respond to concerns." <i style="color: red;"><b style="color: red;">[</b><b>The health IT industry has had several decades to "get it right." When will the experiment end? - ed.]</b></i><br /><br />Management warned<br /><br />Staff superusers <b>have warned management of EPIC issues,</b> and two <b>training sessions in May and June were inadequate</b>, Fagan said.<br /><br />"They were <b>next to useless</b> because the program wasn't in place well enough to practice," she said. "Everyone in the classes could see the gross loopholes in information."<br /><br /><b>Although nurses across the county's health care system have complained</b> <i style="color: red;"><b>[but impediments to diffusion per FDA, IOM etc. prevented the complaints from becoming more widely known - ed.]</b></i>, the problems have been acute in detention, Fagan and Fillingim said.<br /><br />On Monday, one inmate told a nurse she was supposed to be seen by mental health specialists because she was hearing voices, but the follow-up appointment was not registered in the system. The same patient had a Pap smear scheduled for two weeks ago to test for sexually transmitted diseases, but<b> the appointment disappeared from the system,</b> Fagan said.<br /><br />Nurses <b>cannot access tuberculosis history for inmates</b>, so when some are transferred to Immigration and Customs Enforcement, <b>staff cannot provide a full medical summary.</b><br /><b>"We don't exactly know how that happened; we can't tell," she said.</b> </blockquote><blockquote>The kinks will be worked out, and patient safety issues rise to the top of the list, Runt said.<br /><br />"When we go live is just a point in time, and now it becomes a period of stabilization and optimization," he said.</blockquote><br />I think the line <b>"We don't exactly know how that happened; we can't tell" </b>sums up the dangers of today's EHR's, a.k.a. clinical resource and clinician workflow control systems, very well.<br /><br />I note that nurses is California may be a bit better prepared to recognize and call out the dangers of ill-designed and ill-implemented health IT than those in other states. See my post "<a href="http://macadamya.blogspot.com/2012/03/rerun-health-information-technology.html" target="_blank">Health Information Technology Basics From Calif. Nurses Association and National Nurses Organizing Committee</a>."</div><div class="articleBody" id="articleBody"></div><div class="articleBody" id="articleBody"><br />Regulation, anyone, or shall the experiment continue as-is? </div><div class="articleBody" id="articleBody"><br /></div><div class="articleBody" id="articleBody">-- SS<b><br /></b></div></div>Anonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com2tag:blogger.com,1999:blog-773490050994804177.post-56931555964747707472012-08-14T14:28:00.000-07:002012-08-15T07:28:29.517-07:00When Does Lavish Executive Compensation Become "Embezzlement?"A <a href="http://www.miamiherald.com/2012/08/03/2930352/miami-beach-health-center-says.html">single article</a> in the Miami Herald raises the question of when is excessive executive compensation in health care too excessive. To set up the question, I will be quoting from the story in an order quite differently from how the story was presented.<br /><br /><strong>Background</strong><br /><br />The story is about the executives of the Miami Beach Community Health Center, described thus:<br /><blockquote>Headquartered on Biscayne Boulevard in North Miami, the Miami Beach Community Health Center is one of the oldest and most well-respected public health clinics in Florida. It opened more than three decades ago, and now includes four locations, three on the Beach, including two sites that care for people with mental illness. The center employs more than 280 people, with a monthly payroll of around $1.2 million.<br /><br />The health center’s annual budget is about $36 million — about one-third of which comes from private insurance, Medicaid, the state and federal health insurance for needy people, Medicare, the federal insurer for elders, and private payments.</blockquote><br /><strong>The CEO's Compensation</strong><br /><br />Previous stories, and public records suggested that the Center's CEO, Kathryn Abbate, was very well compensated. First,<br /><blockquote>an October 2010 Miami Herald business story ..., relying on federal tax documents, reported <em>Abbate’s compensation package as <strong>$824,000</strong> in 2008</em>. In the article, Abbate said the compensation package was inflated by cashed-out sick time, vacation time and a retirement account.</blockquote><br />She did even better in subsequent years,<br /><blockquote>The Miami Beach Community Health Center’s<em> federal tax report for 2010 indicates Abbate’s base salary was $261,165 — but includes an additional $956,584 in 'bonus and incentive' dollars that pushed her total compensation to <strong>more than $1.2 million</strong></em>. The center’s IRS disclosure <em>for the prior year reported Abbate’s base salary as $970,532, and total compensation of <strong>$987,902</strong></em>. In 2008, Abbate’s total reported compensation was $824,686, records show.</blockquote><br />The CEO got very generous compensation given the size of her organization. This compensation was documented on forms the organization submitted to the IRS that were in the public domain.<br /><br />However, as we have discussed many times before (look <a href="http://macadamya.blogspot.com/search/label/executive%20compensation">here</a>), many leaders of health care organizations, including non-profit organizations, have been collecting very generous compensation.<br /><br /><strong>The Role of the Board of Trustees</strong><br /><br />As we have discussed before, e.g., <a href="http://macadamya.blogspot.com/2012/05/more-rising-compensation-for-executives.html">here</a>, exceptional compensation for top hired managers is often justified by the governing boards, that is, boards of trustees or directors, to whom the hired managers nominally report. These governing board members often seem to be working off a common set of "talking points." <br /><br />In this case, there was a difference. The Herald reported that the Centers board of trustees "<em>never agreed to pay Abbate more than $300,000</em>, [Center Chief Medical Officer Dr Mark] Rabinowitz said."<br /><br />The board seemed totally unaware of what their organization was paying its CEO.<br /><blockquote>Rabinowitz and a health center spokeswoman, Alia Faraj-Johnson, said that board members they spoke to had not seen the [2010] newspaper story [about the CEO's 2008 compensation]until just recently, and acknowledged its content would have raised significant red flags.<br /><br />'That would have tripped everybody’s light,' Rabinowitz said.</blockquote>Why the board had never thought to look at the organization's own reports (990 forms) to the US Internal Revenue Service which detailed the executives' compensation, reports that were in the public domain, and are easily available online (look<a href="http://www.guidestar.org/organizations/59-1829984/miami-beach-community-health-center.aspx"> here)</a>, is unknown.<br /><br />The article implied that the board was somehow not up to this task even though it has fiduciary responsibilities to oversee the top hired managers, oversee the overall budget, and try to maintain both the organization's mission and fiscal stability did not seem up to the task. The article noted,<br /><blockquote>board members <em>remained unaware until last spring</em>. Under federal law, at least half of the board members of federally subsidized health centers such as Miami Beach’s must be consumers of the clinic, and some of the clinic’s board members were <em>simply ill-equipped to detect what the center calls a sophisticated financial crime.</em></blockquote><br />The board members seemed to think that it was the job of the CEO's subordinates to keep tabs on her compensation,<br /><blockquote>'One of the sad things about this, regrettably, is that<em> if the gatekeeper in this case, the chief financial officer, had done his job, a large portion of this would have been discovered a long time ago,' </em>said Bill Dillon, a Tallahassee-based healthcare lawyer who is advising the center.</blockquote><br />The Chief Financial Officer contended that he would not have been able to successfully blow the whistle:<br /><blockquote>[CFO Stanley] DeHart, who lives in Coral Springs, said he was aware of many of Abbate’s activities, but declined to alert the board of directors. <em>'The board of directors was very close to her, and I really thought they would not believe me,'</em> DeHart said. 'They held her in very high esteem.'<br /><br />DeHart and members of his staff 'discussed whistle-blowing,' he said, but they all agreed taking such an action was more likely to result in their firing than Abbate’s. 'I felt at the time, and I still feel, that I had no proof that the board of directors would accept.'<br /><br />And, DeHart added, blame for the scandal should include outside auditors, who failed to raise any objections when Abbate wrote dozens of checks to herself for 'community development' — a department that regularly generated an enormous amount of 'abnormal activity.' DeHart said he told auditors he suspected something was amiss in the community development department.<br /><br />'The external auditors had to have known about this,' DeHart said, 'because I laid it out to them in plain view. I did not hide anything.'</blockquote><br />In fact, the CEO's total compensation, plus a variety of other payments she seemed to direct to herself, were not made clear until<br /><blockquote>May, after a routine audit required by federal funders turned up irregularities, said Mark Rabinowitz, an obstetrician and gynecologist who is the center’s chief medical officer. Abbate had written a check for $5,000 to herself, and cashed it, labeling the expenditure a 'community development' expense....</blockquote><br />Only after that,<br /><blockquote><em>Calling the actions of their former administrator an 'outrageous betrayal of trust,</em>' authorities with the Miami Beach Community Health Center are investigating what they call the theft of almost $7 million in taxpayer money by the center’s longtime chief executive.<br /><br /><em>Members of the health center’s board of directors fired Chief Executive Officer Kathryn Abbate, saying she diverted the nearly $7 million in money intended to provide healthcare for the needy to her personal use beginning in 2008</em>.</blockquote><br /><strong>Summary</strong><br /><br />So let me backtrack a bit. The board of a moderately big, non-profit community health center seemed to make no attempt to monitor the organization's finances, did not even review the organization's own filings with the US government, and therefore had no idea what they were paying their CEO. Nonetheless, they seemed to assume that the organization's finances would be kept in order by an executive who reported to that same CEO. When an audit ordered externally ordered revealed that the CEO was being paid much more than the board had assumed, they charged "embezzlement," again even though a good chunk of such payments were in the form of compensation reported to the US government. <br /><br />The real distinction between this case and many other cases of huge <a href="http://macadamya.blogspot.com/search/label/executive%20compensation">executive compensation</a> we have discussed is that in this one the board seemed to be trying to maintain "plausible deniability" of any knowledge of the CEO's compensation, even though supervising that compensation was its direct responsibility. In other cases, board seem fully aware of enormous compensation, but blithely dismissive of any concerns about it. <br /><br />So does this case could represent "embezzlement, " why were all the other cases of hired managers lavishly compensated not so regarded, even when their compensation was completely out of proportion to their known accomplishments, their organizations' financial performance, much less their organizations' fulfillment of their missions and positive impact on patients' and the public's health? In many of those cases, the money paid out in executive compensation was also partially derived from taxpayers, and also was partially meant to "provide healthcare for the needy."<br /><br />As I have said many times 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. <br /><br /><br />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. Anonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com2tag:blogger.com,1999:blog-773490050994804177.post-78667266482410753022012-08-13T16:16:00.000-07:002012-08-15T07:28:29.543-07:00Old Mystery Solved? Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of SafetyAt my Dec. 2005 post "<a href="http://macadamya.blogspot.com/2005/12/report-life-science-manufacturers.html" target="_blank">Report: Life Science Manufacturers Adapt to Industry Transition</a>" I wrote:<br /><br /><blockquote class="tr_bq">... The recognition of a gap in formally-trained medical informatics-trained personnel in the pharmaceutical industry [by Gartner Group] is welcome. For example, from my own experience:<br /><br />I recall an interview I had last year with the head of the Drug Surveillance & Adverse Events department at Merck Research Labs in a rehire situation [after a 2003 layoff]. I came highly recommended by an Executive Director in the department, to whom I had shown my prior work. This included well-accepted, novel human-computer interaction designs I'd developed for use by busy biomedical researchers for a large clinical study in the Middle East, as well as my work modeling invasive cardiology and leading the development and implementation of a <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/scotsilv/invascard.htm" target="_blank">comprehensive information system</a> to detect new device and treatment modality risks in a regional center performing more than 6,000 procedures/year. In addition, I'd worked with the wife of the Executive Director in years prior, when she ran the E.R. of the hospital where I was director of occupational medicine.<br /><br />Despite all this in my favor, the Executive Director's boss, himself a former FDA adverse events official <i style="color: red;"><b>[a former deputy director of CDER’s office of drug safety, who'd recently moved to the pharma industry he once regulated - ed.]</b></i>, <b>dismissed me in five minutes as I was showing him the cardiology project, saying flatly "we don't need a medical informatics person here." </b>I had driven 80 miles to Rahway for this interview to save the executive a trip to Pennsylvania, where I was originally scheduled to come for the interview, since the executive's father was ill in the hospital. In an instance of profound social ineptness, my effort was not even acknowledged. Perhaps he was in a bad frame of mind, but the dismissal under the circumstances was all the more disappointing.</blockquote><br />I recall this was one of the most puzzling hiring debacles I'd ever experienced, as all the senior people in his dept. had recommended he hire me - I was really only there for his approval and signoff - and the work I'd shown him had improved care, saved lives, and saved money.<br /><br />I may not need to be puzzled any longer. This story just appeared:<br /><br /><blockquote class="tr_bq"><span style="font-size: small;"><b><a href="http://truth-out.org/news/item/10524-former-fda-reviewer-speaks-out-about-intimidation-retaliation-and-marginalizing-of-safety" target="_blank">Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety</a></b></span><br />By Martha Rosenberg, <a href="http://truth-out.org/" target="_blank">Truthout </a><br />July 29, 2012 <br /><br />The Food and Drug Administration (FDA) is often accused of serving industry at the expense of consumers. But even FDA defenders are shocked by reports this week of an institutionalized FDA spying program on its own scientists, lawmakers, reporters and academics that included an enemies list of "actors" and collaborators <br /><br />... Ronald Kavanagh [FDA drug reviewer from 1998 to 2008]: ... In the Center for Drugs [Center for Drug Evaluation and Research or CDER], as in the Center for Devices,<b> the honest employee fears the dishonest employee</b>. There is also irrefutable evidence that <b>managers at CDER have placed the nation at risk by corrupting the evaluation of drugs and by interfering with our ability to ensure the safety and efficacy of drug ... </b>While I was at FDA, drug reviewers were clearly told not to question drug companies and that <b>our job was to approve drugs.</b></blockquote><br /><span class="itemAuthor">Read the entire story at the link. I won't cover it more here, except to say it's certainly possible to believe certain FDA officials don't want serious people around -- who in addition to being MD's can write serious software to detect drug and device problems -- whose work can get in the way of drug approvals.</span><br /><br />-- SSAnonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com0tag:blogger.com,1999:blog-773490050994804177.post-57414354795753767232012-08-13T11:19:00.000-07:002012-08-15T07:28:29.566-07:00A Bonus for Bankruptcy? - KV Pharmaceutical Reveals CEO's Bonus, then Declares BankruptcyThe latest example of the disconnect between compensation for leaders of health care organizations and their and their organizations' performance comes from a <a href="http://www.bizjournals.com/stlouis/news/2012/07/26/kv-pharmaceutical-ceo-divis-pay-more.html">report</a> in the St Louis Business Journal. <br /><br /><strong>Executive Compensation and KV Pharmaceutical</strong><br /><br />Its essence was:<br /><blockquote><em>KV Pharmaceutical Co. President and CEO Gregory Divis Jr. earned <strong>$976,270</strong> in the fiscal year<strong> ended March 31</strong></em>, more than double the $385,102 he was paid in fiscal 2011, according to a proxy statement the company filed Thursday with the Securities and Exchange Commission.<br /><br /><em>His 2012 earnings were comprised of a $638,750 salary, a <strong>$130,000 bonus, $204,189 in option awards</strong> and $3,331 in other compensation</em>, which includes a $2,909 car allowance, a 401(k) match and group term life insurance.<br /><br />The total pay for other top executives was as follows:<br /><br />Treasurer and Chief Financial Officer Thomas McHugh earned $506,615 in fiscal 2012, including a $65,000 bonus. Hit total comp in fiscal 2011 was $320,950.<br />Vice President, General Counsel and Secretary Patrick Christmas earned $530,604 in fiscal 2012. He joined the company in June 2011.</blockquote><br />Admittedly, compensation of just under $1 million a year does not seem that high for the CEO of a pharmaceutical company in this day and age. Furthermore, as <a href="http://www.forbes.com/sites/edsilverman/2012/07/30/kv-pharma-ceo-gets-hefty-raise-despite-all-the-problems">noted</a> in Forbes, Mr Divis' compensation is less than that of his predecessor:<br /><blockquote>who was interim ceo and president, received $1.25 million before Divis succeeded him, and so the ceo is now being compensated at a lower amount. </blockquote><br /><strong>The Troubled History of the Company</strong><br /><br />However, first consider that the company was not exactly in the best financial health at the time Mr Divis was getting his pay, as per the St Louis Business Journal:<br /><blockquote>KV Pharmaceutical Co. officials said July 20 that the company has been <em>notified by the New York Stock Exchange that it is below listing standard criteria</em> due to the company’s average market capitalization being less than $50 million over a 30-day trading period and its stockholder’s equity being less than $50 million.<br /><br /><em>After years of missteps, mismanagement and mounting losses, KV Pharmaceutical’s ability to survive is in question</em>. <em>The company itself raised doubts as to its ability to continue as a going concern in its quarterly filing<strong> Feb. 9</strong></em> with the Securities and Exchange Commission. [Note that this filing occurred during the same fiscal year in which the CEO received the compensation noted above - Ed.]</blockquote><br />In fact, as we discussed <a href="http://macadamya.blogspot.com/2010/11/former-kv-pharmaceutical-ceo-and.html">here</a> in 2010, a former KV Pharmaceutical CEO and Chairman is one of the very few for-profit health care corporate leaders who actually received personal punishment due to a US government prosecution. Former CEO and Chairman Marc Harmelin was banned from doing business with the US government for 20 years after a fraud prosecution that lead to "a KV subsidiary's conviction on criminal charges earlier this year for shipping oversize morphine tablets" <a href="http://www.stltoday.com/business/kv-s-hermelin-is-banned-from-federal-health-care-programs/article_f51abe32-a767-5f3b-bf55-4978db665cab.html">per</a> the St Louis Post-Dispatch.<br /><br /><strong>The Failed Strategy to Get a License for a Previously Generic Drug, and Increase its Price by Ten Thousand Percent (10,000%)</strong><br /><br />Then consider the direction company leadership took after that setback. As described in an August, 2012, St Louis Post-Dispatch <a href="http://www.stltoday.com/business/local/kv-pharmaceutical-files-for-bankruptcy/article_4a26c62c-dfde-11e1-9ffb-0019bb30f31a.html">article</a>, the company's main strategy was based on a license to sell Makena, an injectable form of hydroxyprogesterone. Hydroxyprogesterone had first been approved in the 1950s. In 2003, a National Institute of Health funded study showed that injecting it reduced the risk of premature birth [Meis PJ, Klebanoff M, Thom E et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med 2003; 348: 2379. Link <a href="http://www.nejm.org/doi/pdf/10.1056/nejmoa035140">here</a>.]. Somehow, with funding from KV Pharmaceutical, "the FDA granted the approval to Hologic, which presented the application and argued for the drug based on medical research sponsored by the National Institutes of Health." After that, while "KV neither invented nor patented Makena, but agreed to pay Hologic nearly $200 million for 'orphan drug' status – and seven years of market exclusivity – for the rights to sell the branded drug." I cannot figure out why either company should have been granted an exclusive right to sell this drug under these circumstances. Nonetheless, once KV Pharmaceutical obtained the rights, <br /><blockquote>Makena sparked a national controversy over <em>its sky-high price – a 100-fold increase over the average cost – about $15</em> – <em>for an already widely available non-branded version</em> of the drug produced by compounding pharmacies.<br /><br />Leading national medical organizations and advocacy groups, including the March of Dimes and two U.S. senators, publicly blasted the pricing.<br /><br />On March 30, 2011, the FDA announced that it would not enforce KV’s market exclusivity because of concerns that the drug would be unaffordable to many women. Hours later, the federal Centers for Medicare and Medicaid Services indicated that states could purchase the compounded version, called 17P, from specialty pharmacies.<br /><br />The resistance prompted KV executives to dramatically lower Makena’s cost, but the move failed to forestall the backlash. As a result, KV’s ambitious sales projections for its latest drug failed to materialize.</blockquote><br /><strong>Bankruptcy</strong><br /><br />That sealed the company's fate, and the same article reported,<br /><blockquote>KV Pharmaceutical Co., once among the St. Louis region’s strongest public companies, now faces yet another survival struggle after filing for bankruptcy.</blockquote><br /><strong>Summary: A Bonus for Bankruptcy</strong><br /><br />So a company that suffered a criminal conviction for selling morphine tables whose dose was twice what was on their label, whose former CEO was banned from the pharmaceutical industry, which based its survival on a scheme to game the regulations to allow it to sell a previous $15 drug for $1500, then paid its CEO nearly $1 million, including over $330,000 in cash bonus and stock options just before it filed for bankruptcy. Note that the CEO "earned" that compensation over a time period during which the company revealed doubts that it could survive as a "going concern."<br /><br />This is a simple, relatively small, but especially graphic example of how leaders of health care organizations are not simply overpaid, but seem to personally profit from their organizations' mismanagement, poor financial results, and last but not least, exploitation of patients. Describing these incentives as perverse seems euphemistic.<br /><br />Economists seem to like to justify outsized executive compensation by citing shareholder value they create, realistically defined as short-term stock price (look <a href="http://macadamya.blogspot.com/2012/04/health-care-dysfunction-explained-by.html">here</a>). One could argue that companies that sell health care products or provide health care directly should measure performance in terms of effects on patients' and the public's health. Putting this aside, however, in this case, the executives seemed to be receiving bonuses not based on shareholder value, or stock price, but for continuing a course that resulted in the complete destruction of shareholder value. (Stock shares lose essentially all their value when a company goes bankrupt.) <br /><br />In this case, and in others we have <a href="http://macadamya.blogspot.com/search/label/executive%20compensation">discussed</a>, executive compensation seems to be based on the ability of executives to control their own pay, which seems more like what economists like to call "rent-seeking," as <a href="http://en.wikipedia.org/wiki/Rent-seeking">defined</a> by Wikipedia, gaining from "manipulating the social or political environment in which economic activities occur, rather than by creating new wealth." <br /><br />Clearly, as long as health care leaders can personally profit however bad their performance is, or even due to their poor performance, we can expect nothing other than worsening performance. Health care will become continually more dysfunctional until true reform makes health care leaders accountable for their actions, and all their effects, on stockholders, but also on patients' and the public's health. Anonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com0tag:blogger.com,1999:blog-773490050994804177.post-19230940138013712182012-08-09T22:51:00.000-07:002012-08-15T07:28:29.596-07:00My Presentation to the Health Informatics Society Of Australia: "Critical Thinking on Building Trusted, Transformative Medical Information: Improving Health IT as the First Step"In early 2011 I was invited to present at the annual convention of the <a href="http://www.hisa.org.au/" target="_blank">Health Informatics Society of Australia </a>(HISA) by its CEO, Louise Schaper, PhD. HISA was aware of my writings and thought a presentation at their conference would be of interest to the Australian informatics and healthcare governance community.<br /><br />Dr. Schaper wrote:<br /><br /><blockquote class="tr_bq">From: Louise Schaper <br />Sent: Thursday, March 24, 2011 10:50 AM<br />To: Scot Silverstein<br />Subject: HIC invitation to deliver a keynote presentation<br /><br />Hi Scot,<br /><br />I trust this email finds you well and I hope spring is bringing you some warmer weather and cheer.<br /><br />I wanted to let you know that the Health Informatics Conference committee met recently and expressed a high level of interest in having you deliver a keynote address at HIC and also to form part of a panel presentation. <br /><br />I know you may not be able to make a commitment to come to Australia in August, but I wanted to let you know what we would love to have you, if circumstances permit you being here. I’m confident we could have your trip sponsored (providing you don’t mind spending some face-time with the sponsoring organisation) and generate some media coverage around your visit.<br /><br />The preliminary program will be advertised in the next few weeks and at the moment I’m leaving a ‘spot’ for you in the hope that you may be able to join us. <b>I know you are in difficult and upsetting circumstances so please know that I’m not intending to add to any pressure – I just wanted to let you know that we would be honoured if you are able to deliver an address at HIC this year and I will keep a speaking spot reserved for you if you think you may be able to accept our invitation.</b><br /><br />Thanks for your time Scot. I look forward to hearing from you.<br /><br />Kindest regards,<br /><br />Louise</blockquote><br />Sadly, the "difficult and upsetting circumstances" she mentioned were my involvement in caring for my mother, seriously injured in May 2010 in a healthcare information technology-related medical misadventure and, by this time, dying.<br /><br />I was thus unable to attend.<br /><br />My mother<a href="http://www.findagrave.com/cgi-bin/fg.cgi?page=gr&GRid=88446972" target="_blank"></a> <a href="http://macadamya.blogspot.com/2011/06/my-mother-passed-away.html" target="_blank">passed away</a> June 6, 2011 of her injuries.<br /><br />In January 2012, Dr. Schaper was gracious enough to re-invite me to the annual 2012 conference in Sydney. I accepted.<br /><br />I attended <a href="http://www.hisa.org.au/page/hic2012/" target="_blank">HIC 2012</a>, held in the Darling Harbour Convention Centre in Sydney 30 July - 2 August 2012. <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="http://1.bp.blogspot.com/-I4-kEFx1E44/UCSqaga1nTI/AAAAAAAAA78/v0d-ftRlpUM/s1600/sydney_IMG_1099a.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="300" src="http://1.bp.blogspot.com/-I4-kEFx1E44/UCSqaga1nTI/AAAAAAAAA78/v0d-ftRlpUM/s400/sydney_IMG_1099a.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">I enjoyed taking pictures like this with my trusty (and portable) Canon SX110 IS. Click to enlarge. More photos <a href="http://www.facebook.com/media/set/?set=a.4025347084034.2161136.1592238231&type=3&l=a25989ee6e" target="_blank">here</a>.</td></tr></tbody></table><br />My powerpoint slides for the presentation entitled "<b>Critical Thinking on Building Trusted, Transformative Medical Information: Improving Health IT as the First Step</b>" are <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/HISA2012_Final.ppt" target="_blank">at this link</a>.<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="http://3.bp.blogspot.com/-L5hGTtbyXQU/UCSrD9_noyI/AAAAAAAAA8E/pFTef8QvIfM/s1600/convention_center_0729121059-00.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="300" src="http://3.bp.blogspot.com/-L5hGTtbyXQU/UCSrD9_noyI/AAAAAAAAA8E/pFTef8QvIfM/s400/convention_center_0729121059-00.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Darling Harbour Convention Centre, Sydney, Australia. Click to enlarge.</td></tr></tbody></table><br />Australia has embarked on a national <a href="http://www.nehta.gov.au/ehealth-implementation/what-is-a-pcher" target="_blank">Personally Controlled Electronic Health Record (PCEHR) project</a> under the auspices of Nehta, the <a href="http://www.nehta.gov.au/" target="_blank">National E-Health Transition Authority</a>. I find this an interesting approach to national health IT; unlike the U.S., whose project is top-down (centrally controlled records), Australia seems to have learned from our mistakes and is initiating health IT as a bottom-up (patient-controlled) initiative.<br /><br />At the conference last week, I delivered a keynote address on the theme of improving health IT as an essential step in leveraging the capabilities of the technology.<br /><br />Being that I am anti-"bad IT" and pro-"good IT", implicit in my address was the issue of the technology's untrustworthiness in 2012, largely due to the unregulated free-for-all its market represents and the poor engineering that is the result.<br /><br />I also participated in a Panel Discussion led by Australian investigative journalist and popular political TV program host <a href="http://www.abc.net.au/tv/qanda/" target="_blank">Tony Jones</a>. Mr. Jones hosts the Australian Broadcasting Corporation's "Q&A - Adventures in Democracy."<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="http://2.bp.blogspot.com/-UF-dusrfBKY/UChXZwtF6rI/AAAAAAAABAo/aSw6UELtKZk/s1600/scot_panel.JPG" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="300" src="http://2.bp.blogspot.com/-UF-dusrfBKY/UChXZwtF6rI/AAAAAAAABAo/aSw6UELtKZk/s400/scot_panel.JPG" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Panel discussion moderated by Australian political commentator Tony Jones, who hosts the show "Q&A" on the Australian Broadcasting Corporation. Click to enlarge.</td></tr></tbody></table><br /><br />I will highlight several key points I made in my keynote and on the panel:<br /><br /><ul><li>Critical thinking is essential at all times in healthcare ... or your patient's dead.</li><li>Critical thinking is not mindless criticism; on the contrary, it is reflective, inquisitive, logical thinking that is focused on deciding what to believe or do.</li><li>Health IT must be trusted by users and patients [and be free of major downsides] - as a primary step before HIT can optimally benefit healthcare </li><li>I pointed out I am not suggesting anything new and that, in fact, I am suggesting something old: "First, do no harm."</li><li>I pointed out the "revolutions" usually have downsides, and IT always produces winners...and losers (per the empirical research of <a href="http://rkcsi.indiana.edu/" target="_blank">Social Informatics</a>). </li></ul><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="http://1.bp.blogspot.com/-ca5rnX6EWAY/UCbeAFXRiyI/AAAAAAAAA-4/ZE8BU6T13hE/s1600/me_presenting_1.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="291" src="http://1.bp.blogspot.com/-ca5rnX6EWAY/UCbeAFXRiyI/AAAAAAAAA-4/ZE8BU6T13hE/s400/me_presenting_1.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Me presenting my keynote, driving home the point that IT on its own won't "revolutionize" healthcare; it is a tool <b>to facilitate the true enablers of healthcare</b> - <b>clinicians</b> - a point that should never be forgotten. Click to enlarge. <span class="hasCaption">From the excellent multimedia piece on the conference <a href="http://www.youtube.com/watch?v=DZg_46wY0E0" target="_blank">at this link</a>.<a href="http://www.youtube.com/watch?v=DZg_46wY0E0" rel="nofollow nofollow" target="_blank"><wbr></wbr></a></span></td></tr></tbody></table><br /><br />I then posed a series of questions of great relevance to understanding health IT realities. Click to enlarge:<br /><br /><br /><div class="separator" style="clear: both; text-align: center;"><a href="http://3.bp.blogspot.com/-1h_7fXgAQlo/UCSZUbqz_nI/AAAAAAAAA6M/1H9R741vfYg/s1600/slide1.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="300" src="http://3.bp.blogspot.com/-1h_7fXgAQlo/UCSZUbqz_nI/AAAAAAAAA6M/1H9R741vfYg/s400/slide1.jpg" width="400" /></a></div><br /><br /><div class="separator" style="clear: both; text-align: center;"><a href="http://4.bp.blogspot.com/-qCksURuXycE/UCSZmCBnZUI/AAAAAAAAA6U/w5bbnBMbg8I/s1600/slide2.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="298" src="http://4.bp.blogspot.com/-qCksURuXycE/UCSZmCBnZUI/AAAAAAAAA6U/w5bbnBMbg8I/s400/slide2.jpg" width="400" /> </a> </div><div class="separator" style="clear: both; text-align: center;"><br /></div><div class="separator" style="clear: both; text-align: center;"><br /></div><div class="separator" style="clear: both; text-align: center;"><a href="http://3.bp.blogspot.com/-8co89tVTfR4/UCSZ3eOyBLI/AAAAAAAAA6c/Sdx9e9poCKA/s1600/slide3.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="300" src="http://3.bp.blogspot.com/-8co89tVTfR4/UCSZ3eOyBLI/AAAAAAAAA6c/Sdx9e9poCKA/s400/slide3.jpg" width="400" /> </a></div><div class="separator" style="clear: both; text-align: center;"><br /></div><div class="separator" style="clear: both; text-align: center;"><br /></div><div class="separator" style="clear: both; text-align: center;"><a href="http://3.bp.blogspot.com/-RtuwQcFsXQM/UCSaLxy85JI/AAAAAAAAA6k/JkCZC2JXL_4/s1600/slide4.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="300" src="http://3.bp.blogspot.com/-RtuwQcFsXQM/UCSaLxy85JI/AAAAAAAAA6k/JkCZC2JXL_4/s400/slide4.jpg" width="400" /></a></div><div class="separator" style="clear: both; text-align: center;"><br /></div><div class="separator" style="clear: both; text-align: center;"><br /></div><div class="separator" style="clear: both; text-align: center;"><a href="http://2.bp.blogspot.com/-MjspeTgpBQk/UCSbZ4en3aI/AAAAAAAAA6s/P5AUfVeYMf0/s1600/slide5.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="298" src="http://2.bp.blogspot.com/-MjspeTgpBQk/UCSbZ4en3aI/AAAAAAAAA6s/P5AUfVeYMf0/s400/slide5.jpg" width="400" /></a></div><div class="separator" style="clear: both; text-align: center;"><br /></div><div class="separator" style="clear: both; text-align: center;"><br /></div><div class="separator" style="clear: both; text-align: center;"><a href="http://4.bp.blogspot.com/--8xs_sDCTss/UCScVfq7Z4I/AAAAAAAAA60/1r_dy-YAYcA/s1600/slide6.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="298" src="http://4.bp.blogspot.com/--8xs_sDCTss/UCScVfq7Z4I/AAAAAAAAA60/1r_dy-YAYcA/s400/slide6.jpg" width="400" /></a></div><div class="separator" style="clear: both; text-align: center;"><br /></div><br />I left it to the audience to answer these questions. <br /><br />I then posed the question "Is health IT being done well?"<br /><br />I provided links to various evidence that it was not, such as the <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572" target="_blank">National Research Council 2009 report</a> on health IT; AMIA's report on its <a href="http://macadamya.blogspot.com/2009/03/health-it-project-success-and-failure.html" target="_blank">workshop on healthcare IT failure</a>, the 2012 U.S. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf" target="_blank">IOM report on safety</a>, the 2012 U.S. <a href="http://www.nist.gov/healthcare/usability/upload/Draft_EUP_09_28_11.pdf" target="_blank">NIST report on usability</a>, work by <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146" target="_blank">Australian Professor Jon Patrick of U. Sydney</a> on health IT defects, and other sources as aggregated <a href="http://macadamya.blogspot.com/2011/02/updated-reading-list-on-health-it.html" target="_blank">at this link</a>.<br /><br />Again, I did not impose views on the audience. I didn't need to, as that corpus speaks for itself.<br /><br />I also clarified terminology that reduces essential caution, such as the terms "electronic medical record" (EMR) and "electronic health record" (EHR) - a source of endless, wasted contention on definitions of which is which - being anachronisms from an earlier age of IT. I pointed out that in 2012 what these innocuous terms somewhat deceptively and disarmingly represent are in reality <b>complex enterprise clinical resource management and clinician workflow control systems</b> – where many, many things can go wrong.<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="http://2.bp.blogspot.com/-fpcu9yW7kEc/UCfDOy3i7VI/AAAAAAAAA_w/DNCyHwaidIY/s1600/slide7.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="300" src="http://2.bp.blogspot.com/-fpcu9yW7kEc/UCfDOy3i7VI/AAAAAAAAA_w/DNCyHwaidIY/s400/slide7.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">"EHR": an innocuous "file cabinet" for records, or something else entirely? Click to enlarge.</td></tr></tbody></table><br /><br />I asked if case reports of health IT unintended consequences (UC’s) were “anecdotal” and to be played down, while studies of health IT benefits to date solid science. I then asked if the reality might be that studies of health IT benefits to date were mostly anecdotal (e.g., in specialized settings; weak observational studies vs. randomized clinical trials) while reports of UC’s <a href="http://macadamya.blogspot.com/2011/08/from-senior-clinician-down-under.html" target="_blank">are risk management-relevant incident report “red flags”</a> pointing to possible systemic problems.<br /><br />I pointed out the common seller marketing memes of beneficence and deterministic efficacy, and asked if these were realistic. I also pointed out the need for <b>transparency </b>about HIT risks, and the impediments to this transparency.<br /><br />Finally, I indicated what was the likely problem affecting all countries involved in EHR projects: that the <b>rigor, ethics and skepticism of medical science itself not applied in the domain of health IT.</b><br /><br /><b>I suggested a simple solution: a paradigm shift in thinking about health IT as another medical device, </b>that needed to be subject to the same methodologies and ethical considerations applicable for decades (or more) in the healthcare delivery sector such as medical devices, pharmaceuticals, and research (and other risk-prone industries e.g., aviation and automotive).<br /><br />My goal was to provoke thinking about these issues, to circumvent blank, uncritical acceptance of industry and industry-supporter memes.<br /><br />I believe I succeeded. Feedback I received was that the audience, including government officials, found many new things to consider as they embark on their national health IT projects.<br /><br />I also heard that some HIT seller representatives were squirming a bit. That was not unexpected. I was taking "control of their message" away from them.<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="http://4.bp.blogspot.com/-xY5Dm-a5tgU/UCStV4jq3eI/AAAAAAAAA8U/1UopRoXTzMY/s1600/jon_IMG_1038a.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="300" src="http://4.bp.blogspot.com/-xY5Dm-a5tgU/UCStV4jq3eI/AAAAAAAAA8U/1UopRoXTzMY/s400/jon_IMG_1038a.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">University of Sydney Professor Jon Patrick presenting on computational linguistics. Jon is the author of a treatise on health IT defects (at <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146" target="_blank">this link</a>), mentioned numerous times on this blog. Click to enlarge.</td></tr></tbody></table><br />Finally, I had a question from the audience, from fellow blogger <a href="http://thehealthcareblog.com/blog/category/matthew-holt/" target="_blank">Matthew Holt of the Health Care Blog</a>. Matthew asked me a somewhat hostile question that I was well prepared for, expecting a question along these lines from the seller community, actually. The question was preceded by a bit of a soliloquy of the "You're trying to stop innovation through regulation" type, with a tad of Merck/VIOXX ad hominem thrown in (I ran Merck Research Labs' Biomedical libraries and IT group in 2000-2003).<br /><br />His question was along the lines of - you were at Merck; VIOXX was bad; health IT allowed discovery of the VIOXX problem by Kaiser several years before anyone else; you're trying to halt IT innovation via demanding regulation of the technology thus harming such capabilities and other innovations.<br /><br />The audience was visibly unsettled. Someone even hollered out their disapproval of the question.<br /><br />My response was along the lines that:<br /><br /><ul><li>VIOXX was certainly not Merck at its best, but regulation didn't stop Merck from "revolutionizing" asthma and osteoporosis via Singulair and Fosamax;</li><li>That I'm certainly not against innovation; I'm highly pro-innovation;</li><li>That our definitions of "innovation" in medicine might differ, in that innovation without adherence to medical ethics is not really innovation. </li></ul><br />(I forgot to mention that I gave an invited presentation to Merck's Drug Surveillance department in 2006, PPT <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/silverstein_merck_informatics_nov2006.ppt" target="_blank">here</a>, long after I was their employee, on the potential use of EHR data to detect drug adverse events sooner than traditional phase IV studies or ad-hoc reporting allowed.)<br /><br />When I spoke of medical innovation requiring ethics, nearly the full audience at my keynote address - hundreds of people - broke out in applause.<br /><br /><div class="O"><div style="mso-char-wrap: 1; mso-kinsoku-overflow: 1; mso-line-spacing: "100 20 0"; mso-margin-left-alt: 216;"><span style="font-family: Calibri; font-size: 178%;"><span style="font-family: Arial; left: -3.74%; mso-special-format: bullet; position: absolute;">•</span></span><span style="font-family: Calibri; font-size: 32pt; mso-ascii-font-family: Calibri; mso-hansi-font-family: Calibri;"></span><span style="font-family: Calibri; font-size: 32pt; mso-ascii-font-family: Calibri; mso-hansi-font-family: Calibri;"></span></div></div>I knew at that point that my talk was a success.<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="http://4.bp.blogspot.com/-zd8FqdOKffs/UCSk0UbsZBI/AAAAAAAAA7g/yQYbGeMaEvU/s1600/Louise_Scot_HIC2012_080212.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="320" src="http://4.bp.blogspot.com/-zd8FqdOKffs/UCSk0UbsZBI/AAAAAAAAA7g/yQYbGeMaEvU/s320/Louise_Scot_HIC2012_080212.jpg" width="240" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">This author with HISA CEO Louise Schaper , PhD. Click to enlarge.</td></tr></tbody></table><br />More photos of my trip are <a href="http://www.facebook.com/media/set/?set=a.4025347084034.2161136.1592238231&type=3&l=a25989ee6e" target="_blank">here</a>. <br /><br />-- SS<br /><br /><b>Addendum: </b>Another added pleasure in my visit Down Under. As Australia and the U.S. respect each other's amateur radio licenses, I was able to operate my handheld radio as "KU3E portable Victor-Kilo." VK is the international radio prefix for Oz. Contacting Australia from the U.S. is considered a "holy grail" of ham radio. It was interesting to hear amateur radio "from the other end."<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="http://4.bp.blogspot.com/-lGuXeHowgnU/UCTGFl_R-NI/AAAAAAAAA9I/4k52PvGjoHM/s1600/vx3.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="http://4.bp.blogspot.com/-lGuXeHowgnU/UCTGFl_R-NI/AAAAAAAAA9I/4k52PvGjoHM/s200/vx3.jpg" width="110" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Yaesu VX-3 Multiband Transceiver</td></tr></tbody></table><br />-- SS<br /><br /><b>Aug. 11, 2012 Addendum:</b><br /><br />An excellent multimedia video of HIC 2012 produced as the conference proceeded has been posted on YouTube at <a href="http://www.youtube.com/watch?v=DZg_46wY0E0">http://www.youtube.com/watch?v=DZg_46wY0E0</a>. It was finished and shown immediately after the conference's conclusion.<br /><br />-- SSAnonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com0tag:blogger.com,1999:blog-773490050994804177.post-31007093444192265832012-08-09T21:19:00.000-07:002012-08-15T07:28:29.632-07:00Defense Attorney Lies Under Oath In Sworn Filing to Protect Hospital's Health ITAt my Aug. 7. 2012 post "<a href="http://macadamya.blogspot.com/2012/08/pa-attorney-puts-onc-approved-hit.html">Malpractice Attorney Puts ONC-Authorized Testing and Certification Bodies (ATCBs) at Risk of Litigation?"</a> I wrote:<br /><br /><blockquote class="tr_bq"> ... I returned to the U.S. to find that the defense attorney for the hospital where my mother was severely injured, and then died as a result, is once again raising an absurd issue in objections to the medical malpractice Complaint that was refiled within the Statute of Limitations for technical reasons. The President Judge of the county where the case is filed had dismissed this complaint (among many others) some time ago: </blockquote><br /><blockquote class="tr_bq"><blockquote class="tr_bq"><b>(ii) Plaintiffs Software Design Defect Claims are Preempted by the Federal HITECH Act</b><br /><br />... To the extent Plaintiff attempts to bring a common law product liability claim against [name redacted] Hospital <b>for required use of EMR software</b> <b><i style="color: red;">[see addendum below - ed.]</i></b>, such a claim is barred due to Federal Preemption of this area with the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act. 42 U.S.C. 201, 300, et seq.<br /><br />Specifically, the design, manufacture, specification, certification and sale of EMR in the United States is a <b>highly regulated industry </b>under the jurisdiction of the Department of Health and Human Services (HHS). <b>The HHS draws its statutory authority to design and certify EMR as safe and effective </b>under the HITECH act as amended. Id.<br /><br />The Supremacy Clause of the United States Constitution, article VI, clause 2, <b>preempts any state law that conflicts with the exercise of federal power. </b>Fid. Fed. Say. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 102 S. Ct. 3014 (1982). “Pre-emption may be either express or implied, and ‘is compelled whether Congress’ command is explicitly stated in the statute’s language or implicitly contained in its structure and purpose.” Matter of Calun Elec. Power Co-op., Inc., 109 F.3d 248, 254 (5th Cir. 1997) citing Jones v. Rath Packing Co., 430 U.s. 519, 525 (1977).<br /><br />In this case, to impose common law liability upon [name redacted] Hospital for <b>using certified EHR technology, which was in compliance with federal law and regulations for Health Information Technology</b>, would directly conflict with Congress’ statutory scheme for fostering and promoting the implementation and use of EHR<span style="background-color: white;"></span> <i style="color: red;"><b><br /></b></i></blockquote><br />I really don't think Congress intended HIT to maim and kill patients with impunity. In any case, this assertion was thrown out in its entirety several months ago, but<i> here it is again in a new set of objections. </i>I find its reappearance remarkable. I also wonder if the industry is behind it.</blockquote><br />What I didn't post is the reply to this nonsense that was presented to the court by Plaintiff (me), via Plaintiff's counsel after my analysis of this passage, in a Memorandum of Law to the court Dec. 5, 2011:<br /><br /><blockquote class="tr_bq">... HHS does not regulate the design, manufacture, specification, certification, and sale of EMRs or any other clinical information technology. The HITECH Act itself does not establish standards and certification criteria for health information technology, but instead establishes the HIT Standards Committee to implement such specifications and standards for certification. HITECH Act § 3003, 42 U.S.C. § 300jj-13. <br /><br /><b>The initial set of standards specifications and certification criteria were not published until July 28, 2010, approximately 2 months after Mrs. Silverstein entered [name redacted] Hospital. </b>Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 75 Fed. Reg. 44589 (July 28, 2010). <b>Therefore, it would have been impossible for [name redacted] Hospital’s EMR system “to be in compliance with federal law and regulations for Health Information Technology” during the time of Mrs. Silverstein’s admission. </b></blockquote><br />These facts were filed with the Court and delivered to the defense on Dec. 5, 2011 regarding health IT certification. An Affidavit/Certificate of Service to the defendants was also filed with the Response and Memorandum of Law as is customary, and are noted on the Prothontary website. No "I didn't receive it" excuse is possible...<br /><br />The facts about health IT "certification" are trivial to verify. <br /><br />As the hospital admission where my mother was injured, and the injury itself, were in May 2010, "<b>using certified EHR technology</b> <b>in compliance with federal law and regulations for Health Information Technology</b>" was <i>not possible at that time</i>. (Not to mention the facilities' EHR's were not actually "certified" until December 2010 via the ONC database of certified systems.)<br /><br />Thus, the defense attorney by re-issuing this claim in August 2012 (to the new judge overseeing the case re-filing) is now <i>knowingly lying to the Court in sworn filings</i>, in order to harass, cause unnecessary delays in litigation, and needlessly increase the cost of litigation while collecting hourly fees for production of frivolous and untrue assertions.<br /><br />The attorney is also making a mockery of the court system in the locality where the case is being heard, and also insulting the judges' intelligence. <br /><br />These are the lengths to which hospitals and defense attorneys seem to be willing to go in defense of health IT. I find this remarkable (but not surprising).<br /><br />It will be interesting to see how the judge responds to an attorney knowingly trying to blow smoke up his behind.<br /><br />-- SS<br /><br /><b>Addendum: </b>Also pointed out in earlier filings was the fact that use of EMR's is not "required." It seems the defense attorney, besides being a liar, has a thick skull.<br /><br />-- SS<br /><br />Anonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com1tag:blogger.com,1999:blog-773490050994804177.post-65225652630717425272012-08-09T08:57:00.000-07:002012-08-15T07:28:29.657-07:00Needed: A Webcast on Disruptive and Criminal Hospital ExecutivesI received this, unsolicited, via email:<br /><br /><blockquote class="tr_bq"><b>Webcast: Managing Disruptive Docs in a New Era of Hospital-Physician Relations </b><br /><br />If you haven't already purchased this live Webcast, don't miss out! Left unchecked, disruptive physicians do more than just create a negative work environment; they endanger patient care and can lead to million-dollar lawsuits and bad publicity. Our top experts will show you early intervention techniques and a range of effective resources that can help you reduce behavioral problems, retain star physicians, create a healthier workplace and save millions in potential lawsuits.<br /><br />The agenda includes:<br /><br /> Defining and identifying causes of disruptive behavior<br /> Economic consequences of disruptive behavior<br /> Overcoming disruptive physician problems<br /><br />This program will be guided by your questions, so register now and ask away! </blockquote><blockquote class="tr_bq">Your instructors:<br /><br />Alan Rosenstein, MD, MBA<br />Medical Director of Physician Wellness Services<br /><br />David Danielson, JD, CPA<br />Senior Vice President, Clinical Risk Management, Sanford Health<br /><br />Scott Hurst<br />Former Director of Physician Alignment and Recruitment, CHRISTUS Spohn Health System<br /><br />Managing Disruptive Docs in a New Era of Hospital-Physician Relations is designed to help CEOs, COOs, CMOs, group practice administrators, HR leaders, and physicians learn strategies and tactics to prevent, reduce, and limit the severity of disruptive physician incidents.</blockquote><br />"Disruptive physician" is a vague term subject to enormous abuse, leading to <a href="http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians/" target="_blank">sham peer review</a> among other totalitarian tactics. It reminds me of the old Soviet Union's politics.<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="http://3.bp.blogspot.com/-jikiR0WuHc0/UCPhgXOmZWI/AAAAAAAAA5w/3-KhNApWqJ0/s1600/poster-06.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="219" src="http://3.bp.blogspot.com/-jikiR0WuHc0/UCPhgXOmZWI/AAAAAAAAA5w/3-KhNApWqJ0/s320/poster-06.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">You have been deemed a Disruptive Physician, Comrade. You will be given a fair trial, then shot</td></tr></tbody></table><br /><a href="http://3.bp.blogspot.com/-jikiR0WuHc0/UCPhgXOmZWI/AAAAAAAAA5w/3-KhNApWqJ0/s1600/poster-06.jpg" style="margin-left: 1em; margin-right: 1em;"></a><br />In particular, this label can be used to suppress clinician concerns about care quality in an era of cost cutting and care manipulation through electronic workflow control systems (e.g., EHR's CPOE, CDS etc.)<br /><br />The potential of being labelled as "disruptive" may be one reason why physician outcry against the very low quality of healthcare IT systems and dangers posed by them is relatively uncommon.<br /><br />Patients - you - ultimately suffer when your physicians fear being your outspoken advocates. <br /><br />As the many stories of healthcare executive malfeasance and profiteering at the expense of patients on this blog indicate, what is really needed for true healthcare reform are webcasts on:<br /><br /><b>MANAGING DISRUPTIVE AND CRIMINAL HOSPITAL EXECUTIVES IN AN ERA OF RAMPANT CORPORATIZATION OF MEDICINE.</b><br /><br />-- SS<br /><br />Addendum: here are additional resources on the “Disruptive Physician”:<br /><br /><b>Abuse of the “Disruptive Physician” Clause</b>,<a href="http://www.jpands.org/vol9no3/huntoon.pdf" target="_blank"> http://www.jpands.org/vol9no3/huntoon.pdf</a><br /><b><br />The Insulting Physician “Code of Conduct”</b>,<a href="http://www.jpands.org/vol13no1/huntoon.pdf" target="_blank"> http://www.jpands.org/vol13no1/huntoon.pdf</a> <br /><br />In the latter article, Lawrence Huntoon MD PhD, and expert on abuses of this label, notes:<br /><br /><blockquote class="tr_bq">... The typical physician code of conduct is initiated by a hospital administration. Its wording is curiously similar from one hospital to the next, suggesting that a template is being circulated.<br /><br />... The physician code of conduct is intentionally insulting, demeaning, and degrading to physicians, and reduces physicians to being treated like juvenile delinquents at a reform school. It assumes that all physicians, like juvenile delinquents, need to be subjected to a long list of prohibited behaviors because, in the hospital administration’s view, physicians are predisposed to such things as theft, destruction of property, and physical and sexual assault. <b>Conspicuous by its absence is any mention of “disruptive” or “abusive” hospital administrators, or any similar code of conduct applicable to a hospital administration.</b></blockquote><br />Dr. Huntoon then goes on to make a recommendation, a "hospital administration’s code of conduct":<br /><br /><blockquote class="tr_bq">... The term “disruptive hospital administrator” and/or “abusive hospital administrator” should be incorporated into the hospital administration’s code of conduct and should be defined as anyone in the hospital administration who, in the view of the medical staff (as determined by majority vote), <b>interferes with the ability of physicians to provide safe and high-quality care to patients in the hospital.</b></blockquote><br />His detailed criteria for “disruptive hospital administrator” in the latter article are worth reading in their entirety.<br /><br />-- SS<br /><span style="font-size: small;"><b><span style="color: #343434;"><span style="font-family: Verdana,Arial,sans-serif;"></span></span></b></span>Anonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com0tag:blogger.com,1999:blog-773490050994804177.post-88333326742403815462012-08-08T19:40:00.000-07:002012-08-15T07:28:29.681-07:00ONC and Misdirection Regarding Mass Healthcare IT FailureIn my keynote address to the Health Informatics Society of Australia in Sydney recently, I cautioned attendees including those in government to be wary of <a href="http://macadamya.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">healthcare IT hyper-enthusiast</a> misdirection and logical fallacy (a.k.a. public relations).<br /><br />In the LA Times story "<a href="http://www.latimes.com/business/la-fi-hospital-data-outage-20120803,0,5302779.story?track=rss&cid=dlvr.it&dlvrit=52116" target="_blank">Patient data outage exposes risks of electronic medical records</a>" on the Cerner EHR outage I wrote of in my post "<a href="http://macadamya.blogspot.com/2012/08/massive-health-it-outage-but-of-course.html" target="_blank">Massive Health IT Outage: But, Of Course, Patient Safety Was Not Compromised</a>" (the title, of course, being satirical), Jacob Reider, acting chief medical officer at the federal Office of the National Coordinator for Health Information Technology is quoted. He said:<br /><br /><blockquote class="tr_bq">"These types of outages are quite rare and there's no way to completely eliminate human error." </blockquote><br />This is precisely the type of political spin and hyper-enthusiast misdirection I cautioned the Australian health authorities to evaluate critically.<br /><br />As comedian Scott Adams <a href="http://www.leany.com/logic/Adams.html" target="_blank">humorously noted</a> regarding irrelevancy, a hundred dollars is a good price for a toaster, compared to buying a Ferrari. <br /><br />Further, when you're the patient harmed or killed, or the victim is a family member, you really don't care how "rare" the outages are.<br /><br /><i><b>Airline crashes are "rare", too. </b></i>So, shall they just be tolerated as a "cost of doing business" and spun away?<br /><br />(As I once wrote, the asteroid colliding with Earth that caused the extinction of the dinosaurs was a truly "rare" event.) <br /><b><br /></b>It seems absurd for me to have to point out that paper, unless there is a mass outbreak of use of disappearing ink, or <i>locally hosted</i> clinical IT, <b>do not go blank en masse across multiple states and countries for any length of time,</b><b> raising risk across multiple hospitals </b><b>greatly, </b><b>acutely and simultaneously. </b>Yet, I have to point out this obvious fact in the face of misdirection.<br /><br />Locally hosted health IT, of course, can only cause "local" chart disappearances. "Local" is a relative term, however, depending on HC organization size, as in the example of a Dec. 2011 regional University of Pittsburgh Medical Center (UPMC) 14-hour outage affecting thousands <a href="http://macadamya.blogspot.com/2011/12/yet-another-glitch-affecting-thousands.html" target="_blank">here</a>.<br /><br />Further, EHR's and other clinical IT, whether hosted locally or afar, had better offer truly <i><b>major</b></i> advantages, <i><b>without</b></i> major risks and disadvantages, over older medical records technologies before exposing large numbers of patients to an invasive IT industry and the largest unconsented human subjects experiment in history.<br /><br />Unfortunately, those basic criteria are not yet apparent with today's systems (see for instance this <a href="http://macadamya.blogspot.com/2011/02/updated-reading-list-on-health-it.html" target="_blank">reading list</a>).<br /><br />EHR's and other clinical IT, forming in reality an <i><b>enterprise clinical resource management and clinician workflow control apparatus</b></i>, have introduced new risk modes including mass <a href="http://macadamya.blogspot.com/2012/06/more-electronic-medical-record-breaches.html" target="_blank">chart theft</a> (sometimes tens of thousands in the blink of an eye); also, mass chart disappearances as in this case - all not possible with paper.<br /><br />At the very least, if hospitals want enterprise clinical resource management and clinician workflow control systems, these should not be relegated to a distant third party.<b> Patients are not guinea pigs upon whom to test the <a href="http://en.wikipedia.org/wiki/Application_service_provider" target="_blank">ASP software model</a> ("software as a service") that, upon failure for any reason, threatens their lives.</b><br /><br />Finally, these complications are a further example why this industry cannot go on without meaningful oversight. The unprecedented special medical device regulatory accommodations must end.<br /><br />-- SSAnonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com0tag:blogger.com,1999:blog-773490050994804177.post-71634356636377042792012-08-08T12:48:00.000-07:002012-08-15T07:28:29.802-07:00Joint Commission Should Be Named As Defendant If Patients Harmed by EHR "Outages"At my recent post "<a href="http://macadamya.blogspot.com/2012/08/massive-health-it-outage-but-of-course.html">Massive Health IT Outage: But, Of Course, Patient Safety Was Not Compromised</a>" over a massive, outrageous Cerner outage to hospitals contracting their clinical IT via an <a href="http://en.wikipedia.org/wiki/Application_service_provider" target="_blank">ASP model</a> (that is, 'software as a service'), I observed:<br /><br /><blockquote class="tr_bq">... The Joint Commission, for example, likely issued its stamp of approval for the affected hospitals, hospitals who had outsourced their crucial medical records functions to an outside party that sometimes went mute. If someone was injured or died due to this outage, they would not care very much about the supposed advantages.</blockquote><br />From the JC's page "<a href="http://www.jointcommission.org/about_us/about_the_joint_commission_main.aspx" target="_blank">About the Joint Commission</a>":<br /><br /><blockquote class="tr_bq"><b>An independent, not-for-profit organization</b>, The Joint Commission accredits and certifies more than 19,000 health care organizations and programs in the United States. Joint Commission accreditation and certification is <b>recognized nationwide as a symbol of quality that reflects an organization’s commitment to meeting certain performance standards.</b></blockquote><br />It's time to up the ante regarding this accreditation body, fully aware of health IT risks (e.g., the Dec 2008 <a href="http://macadamya.blogspot.com/2008/12/joint-commission-sentinel-events-alert.html" target="_blank">Sentinel Events Alert on Health IT</a>) but to date having done little about them. Through my legal work and my speaking to Plaintiff's attorneys, I am becoming increasingly aware of medical malpractice cases that involve an EHR or related clinical IT systems at JC-accredited organizations.<br /><br />In effect, the JC has accredited hospitals whose entire clinical command-and-control structure (the term EHR is an anachronism; these systems are in reality <b>enterprise clinical resource management and clinician workflow control devices</b>)<b> </b>can disappear in the blink of an eye, without warning, raising risk to patients greatly.<br /><br />If I discover that a patient was harmed or killed as a result of, or related to, this massive recent outage of outsourced medical records/workflow control infrastructure, I will be recommending that the Joint Commission, including its leadership, which likely certified the hospital(s) involved for safe operations in areas such as Information Management, <i><b>be named </b></i><i><b>as defendants.</b></i><br /><br />I have informed the JC leadership by email<i><b>.</b></i><br /><i><b> </b></i> <br />-- SSAnonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com0tag:blogger.com,1999:blog-773490050994804177.post-39247941211398507222012-08-07T23:08:00.000-07:002012-08-15T07:28:29.845-07:00Massive Health IT Outage: But, Of Course, Patient Safety Was Not CompromisedHaving been 'Down Under' in Sydney addressing the Health Informatics Society of Australia on the need to slow down their national health IT program - and on the need to think critically about HIT seller public relations exaggerations and hubris - and being very busy, I missed this quite stunning story of a major health IT outage.<br /><br />Just a typical "<a href="http://macadamya.blogspot.com/search/label/glitch" target="_blank">glitch</a>":<br /><br /><blockquote class="tr_bq"><a href="http://ukcampaign4change.com/2012/07/31/lessons-from-a-major-outage/" target="_blank">Some lessons from a major outage</a><br />Posted on July 31, 2012<br />By Tony Collins<br /><br />Last week Cerner had a major outage across the US. Its international customers might also have been affected.<br /><br /><a href="http://www.informationweek.com/news/healthcare/EMR/240004446">InformationWeek Healthcare reported</a> that Cerner’s remote hosting service went down for about six hours on Monday, 23 July. It hit “hospital and physician practice clients all over the country”. <b>Information Week said the unusual outage “reportedly took down the vendor’s entire network” and raised “new questions about the reliability of cloud-based hosting services”.</b><br /><br />A Cerner spokesperson Kelli Christman told Information Week,</blockquote><br /><blockquote class="tr_bq"><blockquote>“Cerner’s remote-hosted clients experienced unscheduled downtime this week. <b>Our clients all have downtime procedures in place to ensure patient safety. <i style="color: red;"> [Meaning, for the most part, blank paper - ed.]</i></b> The issue has been resolved and clients are back up and running. <b>A human error caused the outage. </b><b><i style="color: red;">[I don't think they mean human error as in poor disaster recovery and business continuity engineering - ed.]</i></b> As a result, we are reviewing our training protocol and documented work instructions for any improvements that can be made.”</blockquote></blockquote><br /><blockquote class="tr_bq">Christman did not respond to a question about how many Cerner clients were affected. <a href="http://histalk2.com/2012/07/">HIStalk</a>, a popular health IT blog, reported that<b> hospital staff resorted to paper <i style="color: red;">[if that was true, that paper was OK in an unplanned workflow disruption of major proportions, then why do we need to spend billions on health IT, one might ask? - ed.]</i></b> but it is unclear whether they would have had access to the most recent information on patients.<br /><br />One Tweet by @UhVeeNesh said “Thank you Cerner for being down all day. Just how I like to start my week…with the computer system crashing for all of NorCal [Northern California].”</blockquote><br />Tony Collins is a commentator for ComputerWorldUK.com. He's quoted me, as I wrote in my May 2011 post <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><br /><br />This incident brings to life longstanding concerns about hospitals outsourcing their crucial functions to IT companies. <br /><br />Quite simply, I think it's insane, at least in the foreseeable future, as this example shows.<br /><br />It also brings to mind the concerns that health IT, as an unregulated technology, causes dangers in hospitals with inadequate<b> internal</b> disaster and business continuity functions aside from fresh sheets of paper. Such capabilities would likely be<i> mandatory</i> if health IT were meaningfully regulated.<br /><br />The Joint Commission, for example, likely issued its stamp of approval for the affected hospitals, hospitals who had outsourced their crucial medical records functions to an outside party that sometimes went mute. If someone was injured or died due to this outage, they would not care very much about the supposed advantages.<br /><br />There's this in the article:<br /><blockquote class="tr_bq"><br />... “Issue appears to have something to do with DNS entries being deleted across RHO network and possible Active Directory corruption. <b>Outage was across all North America clients as well as some international clients.”</b></blockquote><br />Of course, <a href="http://macadamya.blogspot.com/2011/12/yet-another-glitch-affecting-thousands.html" target="_blank">patient safety was not compromised</a>.<br /><br />Finally:<br /><br />Imagine being a patient, perhaps with a complex history, in extremis at the time of this outage. <br /><br />I, for one, <b>do not want my own medical care nor that of my relatives and friends subject to cybernetic recordkeeping unreliability and incompetence like this, and the risk it creates.</b><br /><br />-- SS<br /><br />Aug. 8, 2012 addendum:<br /><br />The Los Angeles Times covered this outage in a story aptly entitled "<b><a href="http://www.latimes.com/business/la-fi-hospital-data-outage-20120803,0,5302779.story?track=rss&cid=dlvr.it&dlvrit=52116" target="_blank">Patient data outage exposes risks of electronic medical records</a></b>."<br /><br />They write:<br /><br /><blockquote class="tr_bq">Dozens of hospitals across the country lost access to crucial electronic medical records for about five hours during a major computer outage last week, raising fresh concerns about <b>whether poorly designed technology can compromise patient care</b>. </blockquote><br />My only comment is that the answer to this question is rather axiomatic.<br /><br />They also quote Jacob Reider, acting chief medical officer at the federal Office of the National Coordinator for Health Information Technology, who said:<br /><br /><blockquote class="tr_bq">"These types of outages are quite rare and there's no way to completely eliminate human error" </blockquote><br />This is precisely the type of political spin and misdirection I cautioned the Australian health authorities to evaluate critically.<br /><b><br /></b>Paper, unless there is a mass outbreak of use of disappearing ink, or locally hosted clinical IT, <b>do not go blank en masse across multiple states and countries for any length of time, </b><b>raising risk across multiple hospitals </b><b>greatly, </b><b>acutely and simultaneously. </b>(Locally hosted IT outages only cause "local" mayhem; see my further thoughts on this issue <a href="http://macadamya.blogspot.com/2012/08/onc-and-irrelevant-comparisons.html" target="_blank">here</a>).<br /><br />-- SS <br /><br /><span style="color: black; font-family: "Arial","sans-serif"; font-size: 11.0pt;"></span>Anonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com0tag:blogger.com,1999:blog-773490050994804177.post-24651240207108918502012-08-07T20:03:00.000-07:002012-08-15T07:28:29.957-07:00Malpractice Attorney Puts ONC-Authorized Testing and Certification Bodies (ATCBs) at Risk of Litigation?I am jet-lagged after returning from Sydney, Australia, where I delivered one of the keynote addresses at the Health Informatics Society of Australia annual conference, HIC 2012 (<a href="http://www.hisa.org.au/page/hic2012/">http://www.hisa.org.au/page/hic2012/</a>).<br /><br />My theme in a talk entitled <b>"Critical Thinking on Building Trusted, Transformative Medical Information: Improving Health IT as the First Step"</b> was health IT trust and safety. I was actually invited in 2011 but could not attend; I was helping care for my mother, who was severely injured due to a HIT-related mishap in 2010. Her death in 2011 allowed me to attend now on re-invitation.<br /><br />More on my presentation later.<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="http://4.bp.blogspot.com/-8WkOC8QrrMQ/UCHgy1o1V2I/AAAAAAAAA5U/a_qlGk1BnLc/s1600/bridge.JPG" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="240" src="http://4.bp.blogspot.com/-8WkOC8QrrMQ/UCHgy1o1V2I/AAAAAAAAA5U/a_qlGk1BnLc/s320/bridge.JPG" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">A beautiful view of the Sydney Harbour Bridge and Opera House, taken with a mere Canon SX110IS. Click to enlarge.</td></tr></tbody></table><br /><br />In the meantime, I returned to the U.S. to find that the defense attorney for the hospital where my mother was severely injured, and then died as a result, is once again raising an absurd issue in objections to the medical malpractice Complaint that was refiled within the Statute of Limitations for technical reasons. The President Judge of the county where the case is filed had dismissed this complaint (among many others) some time ago: <br /><b><br /></b><br /><blockquote class="tr_bq"><b>(ii) Plaintiffs Software Design Defect Claims are Preempted by the Federal HITECH Act</b><br /><br />... To the extent Plaintiff attempts to bring a common law product liability claim against [name redacted] Hospital for required use of EMR software, such a claim is barred due to Federal Preemption of this area with the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act. 42 U.S.C. 201, 300, et seq.<br /><br />Specifically, the design, manufacture, specification, certification and sale of EMR in the United States is a <b>highly regulated industry </b>under the jurisdiction of the Department of Health and Human Services (HHS). <b>The HHS draws its statutory authority to design and certify EMR as safe and effective </b>under the HITECH act as amended. Id.<br /><br />The Supremacy Clause of the United States Constitution, article VI, clause 2, <b>preempts any state law that conflicts with the exercise of federal power. </b>Fid. Fed. Say. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 102 S. Ct. 3014 (1982). “Pre-emption may be either express or implied, and ‘is compelled whether Congress’ command is explicitly stated in the statute’s language or implicitly contained in its structure and purpose.” Matter of Calun Elec. Power Co-op., Inc., 109 F.3d 248, 254 (5th Cir. 1997) citing Jones v. Rath Packing Co., 430 U.s. 519, 525 (1977).<br /><br />In this case, to impose common law liability upon [name redacted] Hospital for <b>using certified EHR technology, which was in compliance with federal law and regulations for Health Information Technology</b>, would directly conflict with Congress’ statutory scheme for fostering and promoting the implementation and use of EHR<span style="background-color: white;"></span> <i style="color: red;"><b><br /></b></i></blockquote><br />I really don't think Congress intended HIT to maim and kill patients with impunity. In any case, this assertion was thrown out in its entirety several months ago, but<i> here it is again in a new set of objections. </i>I find its reappearance remarkable. I also wonder if the industry is behind it.<br /><br />As per numerous posts in this blog, such assertions are false - and likely knowingly so in this situation. (In that case, this would be an even more serious matter.)<br /><br />For example as I pointed out at my Feb. 2012 post <a href="http://macadamya.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html" target="_blank">Hospitals and Doctors Use Health IT at Their Own Risk - Even if "Certified"</a>, ONC-Authorized Testing and Certification Bodies (ATCB's) answered my questions about safety, legal indemnification etc. Their work has <b>nothing to do with certifying HIT as safe</b> by their own admission.<br /><br />Also, as in my April 2011 post <a href="http://macadamya.blogspot.com/2011/04/fda-decides-regulating-implantable.html" target="_blank">FDA Decides Regulating Implantable Defibrillator Medical Devices a "Political Hot Potato"; Demurs</a> and my Nov. 2011 post <a href="http://macadamya.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html" target="_blank">IOM Report - "Health IT and Patient Safety: Building Safer Systems for Better Care</a>, the HIT industry is unregulated.<br /><br />On the HIT regulation issue, IOM has itself stated in no uncertain terms that HIT is non-regulated (not "a highly regulated industry") in their report to HHS. For instance, in the aforementioned 2012 report they state (as one example):<br /><br /><blockquote class="tr_bq">... If the Secretary [of HHS] deems it necessary for the FDA to <b>regulate EHRs and other currently nonregulated health IT products</b>, clear determinations will need to be made about whether all health IT products classify as medical devices for the purposes of regulation. If FDA regulation is deemed necessary, the FDA will need to commit sufficient resources and add capacity and expertise to be effective. </blockquote><br />I won't even address the claim that the HITECH Act represents or intended to represent Federal pre-emption of state common law rights. It's without merit, and actually absurd.<br /><br />Worst of all, statements in legal dockets that "<b>HHS draws its statutory authority to design and certify EMR as safe and effective under the HITECH Act" </b>(in reality, private <i>non-governmental</i> ONC-Authorized Testing and Certification Bodies or ATCB's are appointed by ONC to "certify" HIT features and functionality to be compliant with "Meaningful Use" guidelines and do not test for safety or efficacy) <b>potentially puts those private ATCB's at risk for being named defendants in lawsuits </b>where HIT was found unsafe and/or ineffective if upheld.<br /><br />I am sure the ATCB's and ONC would not be happy about that.<br /><b><br /></b>-- SS<b><br /></b><b><br /></b>Anonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com1tag:blogger.com,1999:blog-773490050994804177.post-73689051619379569232012-08-03T09:36:00.000-07:002012-08-15T07:28:29.993-07:00Private Equity, Obfuscatory Advertising, and Making Health Care a Commodity: Lessons from Cerberus Capital ManagementThe use of advertising by Steward Health Care, currently a regional hospital system here in New England, continues to provide lessons about how public relations and marketing may be used to shape the health care policy debate. Stand by because the story is convoluted.<br /><br /><strong>Steward Promotes "New Health Care," Whatever That May Be</strong><br /><br />This week, Commonwealth <a href="http://www.commonwealthmagazine.org/News-and-Features/Online-exclusives/2012/Summer/010-Steward-ads-promote-its-new-health-care.aspx">reported</a> on Steward's latest high profile advertising campaign in the Boston area,<br /><blockquote><em>Steward Health Care is using the Olympics to hone its image</em>. The Boston-based chain of 10 community hospitals, many of which were on the verge of going under when Steward acquired them, is running a series of ads on WHDH-TV (Channel 7) during Olympics coverage that cast the company as <em>a delivery system for a new type of world-class health care.</em></blockquote><br />While visible, the advertisements are notably vague. One features<br /><blockquote>a Steward employee who says she believes 'world class health care is here.' Another of the initial ads features individual doctors and technicians pledging to be <em>stewards of 'the new health care,'</em> which is the tagline for all of the Steward ads.<br /><br />What the 'new health care' means is <em>never fully explained in the ads</em></blockquote><br />One local health care expert <br /><blockquote>Paul Levy, the former CEO of Beth Israel Deaconness Medical Center, said he thinks the ads are part of a campaign by [Steward Health Care owner] Cerberus [Capital Management] to make Steward more attractive to would-be buyers. 'This has very little to do with anything other than establishing the image and the brand of the Steward hospitals so when the day comes when Cerberus sells the company it will be better received in the public markets,' Levy said.</blockquote><br />The article had noted that <br /><blockquote><em>Cerberus Capital Management, a New York private equity firm, owns Steward</em>,...</blockquote><br />So it is possible that no one at Steward really has any idea what sort of "new health care" the organization is promoting<br /><br /><strong>Steward's CEO Promotes Health Care as a Commodity</strong><br /><br />However, there is reason to think that the top leadership of Steward, and probably of Cerberus Capital Management, the private equity group that owns it, actually does have a clear idea what new health care they are promoting.<br /><br />Almost simultaneous with the Commonwealth article and the Olympic advertising campaign an <a href="http://management.fortune.cnn.com/2012/08/02/steward-health-de-la-torre">interview</a> appeared with Steward's CEO in Fortune. CEO Dr Ralph de la Torre first pitched medicine as science,<br /><blockquote>A lot of us physicians went into medicine because we loved the art aspect of it. There wasn't a lot of real hard-core science when many of today's doctors went into medicine. It was your intuition, your abilities, the gestalt of what was going on. But something happened in medicine along the way. It <em>started becoming a real science</em>, and a lot of studies have come out that guide what we do and how we do it. We as a society need to understand that science has to guide our practice of medicine. Not everyone with a headache needs a CAT scan; not everybody with a sprained ankle needs an MRI.</blockquote><br />This sounds like it could be an affirmation of evidence-based medicine, the approach that attempts to base medicine on systematic search for and critical review of the best clinical research, among other things. However, De la Torre takes it a big step further, citing:<br /><blockquote>In deference to those who love the individual hospital, you have to <em>look back at America and the trends in industries that have gone from being art to science, to <strong>being commodities</strong></em>. <em><strong>Health care is becoming a commodity</strong></em>. The car industry started off as an art, people hand-shaping the bodies, hand-building the engines. As it became a commodity and was all about making cars accessible to everybody, it became more about standardization. It's not different from the banking industry and other industries as they've matured. Health care is finally maturing as an industry, and part of that maturation process is consolidation. It's getting economies of scale and in many ways making it a commodity.</blockquote><br />Apparently Dr De la Torre does not see a distinction any longer between health care, or to use an old-fashioned word, medicine, traditionally considered an art or practice of caring for individual patients, and making automobiles on an assembly line. Dr De la Torre may be deeply misinterpreting evidence-based medicine, which is about evidence from clinical research, but also <em>much more</em>. Consider how the Cochrane Collaboration <a href="http://www.cochrane.org/about-us/evidence-based-health-care/">discusses it</a>:<br /><blockquote>Evidence-based health care<br /><br />Evidence-based health care is the conscientious use of current best evidence in <em>making decisions about the care of individual patients</em> or the delivery of health services. Current best evidence is up-to-date information from relevant, valid research about the effects of different forms of health care, the potential for harm from exposure to particular agents, the accuracy of diagnostic tests, and the predictive power of prognostic factors [1].<br /><br />Evidence-based clinical practice is an approach to decision-making in which the clinician uses the best evidence available, <em>in consultation with the patient, to decide upon the option which suits that patient best</em> [2].<br /><br />Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about<em> the care of individual patients</em>. The practice of evidence-based medicine means <em>integrating individual clinical expertise</em> with the best available external clinical evidence from systematic research [3].<br /><br />[1] Cochrane AL. Effectiveness and Efficiency : Random Reflections on Health Services. London: Nuffield Provincial Hospitals Trust, 1972. Reprinted in 1989 in association with the BMJ. Reprinted in 1999 for Nuffield Trust by the Royal Society of Medicine Press, London, <a href="http://www.rsmpress.co.uk/bkcochra.htm">ISBN 1-85315-394-X.</a>[2] Gray JAM. 1997. Evidence-based healthcare: how to make health policy and management decisions. London: Churchill Livingstone.<br />[3] Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. 1996. Evidence based medicine: what it is and what it isn't. BMJ 312: 71–2 [3] [<a href="http://www.bmj.com/cgi/content/full/312/7023/71">Full text</a>]</blockquote><br />Note the emphasis on making decisions for individuals based on what is best for each, and the integration of evidence from clinical research with clinical expertise. This is far from commoditization.<br /><br />Nonetheless, Dr De la Torre seems to envision "new health care" like a 1930s automobile assembly line, with the physicians and other health professionals cast as assembly line workers, and the patients cast as automobiles. <br /><br />Our next example may provide some explanations for this point of view.<br /><br /><strong>Steward's Advertising Raises Questions of Whose Hands Should be on Health Care</strong><br /><br />As we <a href="http://macadamya.blogspot.com/2012/07/steward-health-care-vs-rhode-island.html">discussed earlier</a>, Steward Health Care has been working on acquiring a struggling local Rhode Island hospital system, and in doing so is in a dispute with the statewide non-profit Blue Cross health insurance company. Steward had been putting daily full-page advertisements in the local paper. A recent version (27 July, 2012), had this text:<br /><blockquote>RHODE ISLAND TO BLUE CROSS:<br />GET YOUR HANDS OFF OUR HOSPITALS<br /><br />With 80% of the market under its control, Blue Cross & Blue Shield of Rhode Island thinks it can decide which hospitals survive or fail. The people of Rhode Island beg to differ.<br /><br />For the past decade, they've watched Blue Cross starve Landmark Medical Center of its funding. And this year, when Blue Cross issued an ultimatum to terminate the hospital, Rhode Islanders heard enough.<br /><br /><div class="separator" style="clear: both; text-align: center;"></div>In a poll conducted this week by John Marttila, a nationally recognized leader on public attitudes concerning health care, 76% of respondents said that Blue Cross shouldn't be allowed to use their monopoly to dictate the fate of Rhode Island hospitals. They also felt, by a 2-1 margin, that if Landmark did indeed close, Blue Cross would be to blame.</blockquote><br /><div class="separator" style="clear: both; text-align: center;"><a href="http://2.bp.blogspot.com/-p4KWqchl5SM/UBv6FmpEPuI/AAAAAAAAAFI/pM2z6WMsiZw/s1600/StewardBCBSAdvertisement2%2528072712%2529.gif" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" eda="true" height="233" src="http://2.bp.blogspot.com/-p4KWqchl5SM/UBv6FmpEPuI/AAAAAAAAAFI/pM2z6WMsiZw/s320/StewardBCBSAdvertisement2%2528072712%2529.gif" width="320" /></a></div>However, soon after, investigative <a href="http://digital.olivesoftware.com/Olive/ODE/ProJo/LandingPage/LandingPage.aspx?href=VFBKLzIwMTIvMDcvMjc.&pageno=MTE.&entity=QXIwMTEwMQ..&view=ZW50aXR5">reporting</a> by the Providence Journal's Ms Felice Freyer revealed that maybe the poll should have been interpreted differently. Not unexpectedly, Ms Freyer revealed the poll to have been "commissioned by Steward." Its basic results were really:<br /><blockquote>Just over half the respondents knew that Landmark was being sold to Steward, and of those, 58 percent did not have an opinion, <em>29 percent supported the sale</em>, and 13 percent opposed it. However, among those who knew about the sale and also live in northern Rhode Island, the approval rating was higher –– 37 percent support the sale, with 15 percent disapproving and 48 percent having no opinion. </blockquote><br />The pollster than provided prompting, perhaps in an attempt to get results more favorable to its client:<br /><blockquote>One of the questions starts with this statement: 'Blue Cross Blue Shield provides health insurance to 80 percent of Rhode Island. By refusing to negotiate on reimbursement rates, Blue Cross can essentially determine if hospitals in the state stay open or if hospitals close.' Based on that statement, 76 percent of respondents agreed that 'Blue Cross should not be allowed to use its monopoly to dictate which hospitals stay open and which close their doors.' </blockquote><br />Unfortunately, it appears that the prompting statement was perhaps not fully accurate:<br /><blockquote>In 2011, Blue Cross covered 66 percent of Rhode Islanders with private health insurance, not 80 percent, according to a report by the Office of the Health Insurance Commissioner.<br /><br />Blue Cross denies that it has refused to negotiate.<br /><br />'We have negotiated in good faith and have offered a fair contract to Landmark Hospital that is consistent with our reimbursement arrangements for other independent hospitals,' Blue Cross said in a statement. 'Unfortunately, Steward has been unwilling to enter into a contract under those conditions.' </blockquote><br />While they touted probably methodologically biased survey results, Steward's local advertising campaign's headline might prompt some people to think about whose hands should really be on their health care. The advertising tries to limit this question to Blue Cross' influence. However, one might also ask whose hands control Steward Health Care?<br /><br /><strong>Whose Hands are on Steward Health Care?</strong><br /><br />As the Commonwealth article above pointed out, Steward Health Care is a wholly owned subsidiary of Cerberus Capital Management, a New York based private equity firm. <br /><br />Cerberus' <a href="http://www.cerberuscapital.com/team/senior_executive_leadership">top leadership </a>includes <br />- CEO Steven A Feinberg, who, as we <a href="http://macadamya.blogspot.com/2012/07/steward-health-care-vs-rhode-island.html">noted</a> previously, was listed as number 21 on a list of the 25 most powerful businessmen in 2007 <a href="http://money.cnn.com/galleries/2007/fortune/0711/gallery.power_25.fortune/21.html">by Fortune</a>, at that time running through Cerberus 50 companies with total revenues of $120 billion. <a href="http://en.wikipedia.org/wiki/Steve_Feinberg">On Wikipedia</a>, his net worth was estimated as $2 billion in 2008.<br />- Chairman John W Snow, who, as we <a href="http://macadamya.blogspot.com/2012/07/steward-health-care-vs-rhode-island.html">noted</a> previously, resigned as Treasury Secretary in the administration of President George W Bush "in 2006 only because it was revealed that he had not paid any taxes on $24 million in income from CSX, which had forgiven Snow's repayment of a gigantic loan that the company had made to him," according to Chareles Ferguson in <a href="http://www.randomhouse.com/book/213722/predator-nation-by-charles-h-ferguson"><em>Predator Nation</em></a>. <br />- Chairman, Cereberus Global Investments J Danforth Quayle, the controversial former US Vice President during the George H W Bush administration.<br /><br />Furthermore, Cerberus Capital Management, which wholly owns Steward Health Care, owns several other businesses. As we noted <a href="http://macadamya.blogspot.com/2011/05/continuing-parade-of-legal-settlements.html">here</a>, these include, DynCorp (see <a href="http://www.dyn-intl.com/history.aspx">their web-site</a>), which has been called one of the "leading mercenary firms," by <a href="http://www.thenation.com/blog/mercenary-owners-they-are-changin-sort">an article</a> in the Nation. As reported <a href="http://www.bloomberg.com/news/2011-04-22/dyncorp-to-pay-7-7-million-for-inflated-claims-on-iraq-work-u-s-says.html">by Bloomberg</a>, DynCorp, and hence indirectly about Cerberus, and Steward Health Care, in 2011 settled accusations that it overbilled the US government for construction work in Iraq. Furthermore, as we noted <a href="http://macadamya.blogspot.com/2011/02/send-mercenaries-guns-and-money.html">here</a>, Cerberus also owns the biggest manufacturer of firearms and ammunition in the US. As <a href="http://www.businessweek.com/magazine/content/10_33/b4191041673261.htm">reported</a> by BusinessWeek in 2010, Cerberus owns 13 brands of fire-arms and munitions under the umbrella Freedom Group. <br /><br />So while Cerberus Capital Management would like us to believe that Rhode Island residents question the hands of Blue Cross Blue Shield of Rhode Island on a struggling local hospital system, it seems to be trying to avoid questions about whose hands would be on the hospital system were Cerberus Capital Management's subsidiary Steward Health Care to acquire it. <br /><br /><strong>Summary</strong><br /><br />So, to recapitulate this winding story.... A regional hospital system has been pushing its "new health care" idea. However, its former surgeon CEO promotes new health care as commoditized health care, assembly line health care, in which doctors become assembly line workers and patients become widgets. This seems bizarre until one realizes that the CEO actually works for a huge private equity firm whose goal is to make a lot of money in the short-term. Standardized, commoditized health care is likely to be cheaper to provide than individualized health care. Private equity firms thrive by cutting their subsidiaries' costs, and then selling them quickly, sometimes before the long-term consequences of these cuts become apparent. (Look <a href="http://macadamya.blogspot.com/2012/01/barbarians-at-gate-making-private.html">here</a>.)<br /><br />So there are two lessons.<br /><br />To repeat the lesson from our <a href="http://macadamya.blogspot.com/2012/07/steward-health-care-vs-rhode-island.html">earlier post</a>, everybody, doctors, other health care professionals, health policy makers, patients, and the public ought to be extremely skeptical of the marketing and public relations efforts of big health care organizations. Based on the examples above, they ought to be particularly skeptical of organizations that are overtly for profit, and/or have a clear focus on short-term revenue generation. As a society we need to think about how to best counter these biased, incomplete, sometimes grossly deceptive efforts to manipulate public psychology and opinions through our rights to free speech and a free press.<br /><br />To add a lesson, everybody, doctors, other health professionals, health policy makers, patients and the public ought to be extremely wary of the ongoing corporatization of medicine and health care. Corporate leaders who often get large incentives for maximizing short term revenue are likely to be enthused about turning our health care into a commodity. Doctors and health care professionals should not want to be assembly line workers, and patients surely should not want to be widgets. Anonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com5tag:blogger.com,1999:blog-773490050994804177.post-4850845446418425272012-08-01T09:14:00.000-07:002012-08-15T07:28:30.104-07:00More "Visionary" Leadership That Turned Out to be "More Interested in Flash than Substance" - Continuing Troubles at the University of MiamiOver the last 20 years or so, health care organizational leaders somehow ceased to be mere mortals, and became visionaries. The latest example of how their visions turned out to be cloudy <a href="http://www.miamiherald.com/2012/07/22/2918375/um-med-schools-big-ambitions-led.html">appeared</a> in the Miami Herald.<br /><br /><strong>Background: Donna Shalala as "Visionary" President of the University of Miami</strong><br /><br />Donna Shalala, formerly the US Secretary for Health and Human Services, became President of the University of Miami in 2001 (see her official biography). She has since been hailed literally for her "<em>visionary leadership</em>" (as <a href="http://www.med.miami.edu/news/view.asp?id=466">recipient</a> of the Health Leadership Award from the National Hispanic Medical Association in 2005). In 2008, then US President George W Bush <a href="http://weblogs.sun-sentinel.com/news/politics/dcblog/2008/06/bush_awards_donna_shalala_meda_1.html">awarded</a> her the US Medal of Freedom, the highest US civilian award, as "one of our nation’s most distinguished educators and public officials. She has <em>worked tirelessly to ensure that all Americans can enjoy lives of hope, promise and dignity</em>.")<br /><br />At the University of Miami, as <a href="http://chronicle.com/article/Fast-Growth-Strategy-Has-Its/127941/">described</a> in a detailed investigative report by Paul Basken in the Chronicle of Higher Education in 2011, Ms Shalala pursued a grand strategic vision to " bring the University of Miami into the ranks of the nation's elite research universities." In an interview at that time, she claimed to have had "a very disciplined strategic plan to make this place much, much better, to move into the top ranks of American universities."<br /><br /><strong>Cracks in the Wall Appear in 2011</strong><br /><br />However, Mr Basken reported that by 2011, that strategy was showing signs of failure. He noted problems including rising deficits and a worsening credit rating; allegations that the university was failing to meet the needs of the poor patients for whom its doctors had traditionally cared for at Jachson Memorial Hospital while favoring paying patients at its newly acquired medical center; and concerns about conflicts of interest affecting top leadership of the university, including Ms Shalala (see our post <a href="http://macadamya.blogspot.com/2011/06/embedded-networks-of-influence-in.html">here</a>). At the time, university leadership scoffed at the importance of these problems. For example, Ms Shalala ridiculed doctors "who gripe" that the university had become over-extended by pushing research over patient care as "these people complaining they want to <em>live their little lives</em> without being researchers." <br /><br />After the 2011 report came out, Ms Shalala <a href="http://chronicle.com/article/Shalala-Articles-Conclusions/128021/">ridiculed</a> it in print as "a shocking example of irresponsible and lazy reporting."<br /><br />Note that on Health Care Renewal, we had previously raised questions about Ms Shalala's conflicts of interests, particularly her role on the board of UnitedHealth at the time its CEO was receiving hundreds of millions in back-dated stock options (in 2006, look <a href="http://macadamya.blogspot.com/2006/03/questionable-timing-of-unitedhealth_20.html">here</a>); and about her priorities, including the contrast between her lavish compensation, which encompassed her residence in a fully-staffed mansion, and how the university treated its low level workers, particularly its janitors who did not receive health insurance (also in 2006, look <a href="http://macadamya.blogspot.com/2006/02/tale-of-three-ironies-university-of.html">here</a>). <br /><br /><strong>The Cracks Widen in 2012</strong><br /><br />In retrospect, Mr Basken's article appears quite responsible and accurate. Last week the Miami Herald <a href="http://www.miamiherald.com/2012/07/22/2918375/um-med-schools-big-ambitions-led.html">reported</a> that Ms Shalala's "ambitious moves vaulted UM’s medical school to the national stage — but they may also have seriously damaged it." Soon after Ms Shalala ridiculed the Chronicle of Higher Education article, already internal reports showing even more trouble were appearing. <br /><blockquote>As far back as October, billionaire car dealer Norman Braman wrote in a memo to fellow UM trustees that he and colleagues had been receiving anonymous letters for months 'outlining <em>a host of wrongdoings,</em> mostly at the medical school. Braman and others closely tied to the school warned UM officials the medical school was spending too much, too fast in the push to build a world-class medical center.</blockquote><br />There were problems beyond those described by the CHE article:<br /><blockquote>The medical school also had major problems of its own. According to internal documents, the school suffered from <em>bloated staffing, a faulty billing system and prices that sometimes ran much higher</em> than at other South Florida hospitals. <em>Internal controls apparently were weak</em> at best: A whopping $14 million in expensive cancer drugs disappeared from a UM pharmacy over three years before an employee was charged with theft in June 2011.<br /><br />The medical school’s difficulties even began to impede its relationship with the ailing, taxpayer-financed Jackson Health System, endangering a decades-long partnership with the public hospital system.</blockquote><br />The Herald article includes substantially more detail to support these assertions. <br /><br />Trustee Braman summarized it thus:<br /><blockquote><em>Poorly conceived decisions by the medical school administration have put the university at significant risk</em> and, at the same time, injured Jackson Memorial Hospital.</blockquote><br />As we <a href="http://macadamya.blogspot.com/2012/06/university-of-miami-lays-off-800-cuts.html">noted</a>, earlier this year the university's financial problems lead to layoffs, but at the same time, the university was building an even fancier mansion for President Shalala. After the lay-offs, Braman said they were:<br /><blockquote>a real tragedy that never should have happened. ... The <em>people at the top were very much more interested in flash than substance</em>.</blockquote><br /><strong>Summary</strong><br /><br />Since the early 1990s we have suffered the rise of extremely confident, extremely well-paid, "visionary" health care leaders. Anyone within the organization who doubted their visions risked being labeled a malcontent or worse. Any skeptic outside the organization might be met by a barrage of propaganda from the organization's well financed public relations operation. Yet the visions these leaders produced often appeared to be clouded at best. <br /><br />One of the most striking early examples remained anechoic for a long time. The then CEO of the Allegheny Health Education and Research Foundation, Sharif Abdelhak, was publicly labeled a "visionary" and "genius" for assembling a large, vertically oriented health care system, which eventually went bankrupt. Abedlhak went to jail. (Look <a href="http://macadamya.blogspot.com/2012/04/pittsburgh-experiment-ii-another-echo.html">here</a> for summary). In the greater business world, whose culture now seems to rule health care, there are other examples of such failed visionaries (look <a href="http://macadamya.blogspot.com/2012/05/ceo-as-false-messiah.html">here</a>). Yet this case, and other since, have largely been ignored.<br /><br />However, as the case of the leadership of the University of Miami now seems to show in retrospect, many people seem to fall again and again for the now tired hucksterism of the "visionary," or "genius" leader selling grandiose and often self-serving pipe dreams. <br /><br />Maybe it would be enough in health care to simply aspire to good patient care, responsible education, and honest research. <br /><br />Meanwhile, health care professionals, health policy leaders, and the public at large should start showing appropriately pointed skepticism of our current self-proclaimed "visionary" leadership.Anonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com0tag:blogger.com,1999:blog-773490050994804177.post-79327412728686350862012-07-30T10:00:00.000-07:002012-08-15T07:28:30.224-07:00Another Story of Unaccountable Leadership from UC-Davis: "World Famous" Neurosurgeon Banned from Research, but Still Department ChairThe University of California - Davis just keeps supplying us with lessons about problems with leadership and governance in major health care organizations.<br /><br />Our latest example comes from <a href="http://www.sacbee.com/2012/07/22/v-print/4648415/2-uc-davis-neurosurgeons-accused.html">a story</a> in the Sacramento (CA) Bee. <br /><br /><b>A Bizarre Series of Surgical Experiments</b><br /><br />It started with two neurosurgeons who embarked on an extremely unorthodox treatment program,<br /><blockquote>Documents show the surgeons got the consent of three terminally ill patients with malignant brain tumors to <i>introduce bacteria into their open head wounds</i>, under the theory that postoperative infections might prolong their lives. Two of the patients developed sepsis and died, the university later determined.</blockquote><br />First, <br /><blockquote>In 2008, the doctors proposed treating a glioblastoma patient with bacteria applied to an open wound to 'attack the tumor,' then later withholding antibiotics and letting the bacteria do its work.</blockquote><br />The FDA responded that animal studies would have to be done before any human research could be considered. Apparently the surgeons intended to do some animal research, but what they did, and what its results were remain unclear. Nevertheless,<br /><blockquote>Between October 2010 and March 2011, the physicians went forward with three procedures on humans with malignant brain tumors, surgically introducing probiotics into their open head wounds.</blockquote><br />One surgeon did get<br /><blockquote>IRB permission to move forward on Patient No. 1 with a 'one-time procedure' that was 'not associated with any research aim,' the letter states.<br /><br />University documents show that the physicians believed they had been given the go-ahead for all three surgeries, but officials later determined that they had been misinformed or were misunderstood by the doctors.</blockquote><br />No patient lived very long. Two developed sepsis before they died. After hearing that the surgeons were then planning to do the procedure on five more patients,<br /><blockquote>The university threw on the brakes.<br /><br />On March 17, 2011, the IRB director ordered the doctors to immediately stop their probiotic treatments, according to university documents.</blockquote><br />I should point out that deliberately introducing bacteria into an otherwise sterile surgical site is a very radical and seemingly periolous step. Furthermore, a <a href="http://www.nature.com/news/can-bacteria-fight-brain-cancer-1.11080">blog post</a> in Nature News suggests that the reasoning used by the surgeons to support this approach was based on extremely weak evidence,<br /><blockquote>researchers at the Catholic University of Rome examined the records of 197 patients treated for glioblastoma between 2001 and 2008, of which ten developed pathogenic infections after surgery. Those patients had a median survival rate of 30 months, whereas patients who did not become infected had a median survival rate of 16 months. However, the authors concluded that the association was 'not definitive'. [De Bonis, P. et al. Neurosurgery 69, 864–868 (2011). Link <a href="http://dx.doi.org/10.1227/NEU.0b013e318222adfa">here</a>. ]<br /><br />A 2009 report considered 382 patients with malignant brain cancer, 18 of whom developed infections. Infected patients lived longer on average, but the difference was not statistically significant. What’s more, the researchers reasoned that infection may correlate with longer survival not because infection prolongs survival but because patients who live longer are more likely to develop infections. [Bohman, L. E. et al. Neurosurgery 64, 828–834 (2009). Link <a href="http://dx.doi.org/10.1227/01.NEU.0000343525.89321.C5">here</a>. ]</blockquote><br /><b>The University Investigation</b><br /><br />Then,<br /><blockquote>The internal investigation began.<br /><br />Six months later, the university concluded its probe – <i>ordering the doctors to halt all human research activity</i> 'except as necessary to protect the safety and welfare of research participants.'<br /><br />In the case of Patient No. 1, the investigation found, ... [one surgeon] had made an 'incorrect statement' about restrictions on the bacteria's use, leading IRB staff to incorrectly conclude that such review was not necessary, Lewin told the FDA.<br /><br />As for Patients 2 and 3, the university found that <i>treating them with an 'unapproved biologic' amounted to human-subjects research – and thus required prior review and approval.</i></blockquote><br />The junior neurosurgeon defended their conduct by claiming<br /><blockquote>We believed that this was innovative treatment, not research, and that IRB approval was not needed</blockquote><br />The senior surgeon asserted that he<br /><blockquote>believed the FDA gave its permission early on, if the doctors thought the treatment was 'beneficial to the patients.' He described the research ban as an <i>"overreaction" by the university</i>.<br /><br />'And I understand it,' he said. There are people who blatantly break the rules that endanger all of their research programs. <i>We certainly didn't blatantly trample any rules</i>.'</blockquote><br />However, <br /><blockquote>A renowned U.S. bioethicist, describing the alleged violations as 'a major penalty,' said the university's IRB was right to intervene – and quickly.<br /><br />Arthur Caplan, director of medical ethics at New York University's Langone Medical Center, said that desperate people are especially vulnerable and need added protections.<br /><br />'If you're dying, you're kind of like reaching out to anything that anybody throws in front of you,' said Caplan</blockquote><br />Furthermore, per a Sacramento Bee <a href="http://www.sacbee.com/2012/07/28/4668495/uc-davis-neurosurgeon-department.html">follow-up article</a>, Elizabeth Woeckner, founder and director of Citizens for Responsible Care and Research, or CIRCARE, said the surgeons' "experiment" was<br /><blockquote>the worst thing I've seen in my 12 years with CIRCARE</blockquote><br /><b>An Overreaction, or an Under reaction?</b><br /><br />So far, this story seems different from many of those discussed on <a href="http://macadamya.blogspot.com/">Health Care Renewal</a>. The questionable conduct it describes, after all, appears to have resulted in serious negative consequences. Furthermore, it seems to have been conduct by two loose cannons, rather than to be a sign of systemic problems with leadership or governance. However, there is more to the story.<br /><br />First, the senior surgeon held a substantial leadership position at the time the events in question occurred. He is<br /><blockquote>[Dr J Paul] Muizelaar, 65, who has been a <i>department chairman at the School of Medicine</i> since 1997</blockquote><br />He is pretty well paid, earning<br /><blockquote>more than <i>$800,000 a year as chairman of the department of neurological surgery</i></blockquote><br />In fact, a <a href="http://www.sacbee.com/2012/07/22/4648465/banned-ucd-doctor-is-one-of-ucs.html">companion article</a> in the Sacremento Bee noted,<br /><blockquote>In 2010 – the same year Dr. J. Paul Muizelaar first performed an experimental treatment on a dying brain cancer patient at UC Davis Medical Center – the neurosurgeon <i>made more money than 99.9 percent of all employees in the University of California system.</i><br /><br />With a total compensation package of $801,841 in 2010, he was the 35th highest earner, behind 27 other physicians, four athletic coaches and three executives, according to the most recent UC salary data.</blockquote><br />More importantly, even though the university's internal investigation was done in the fall of 2011, and at that time Dr Muizelaar was immediately banned from human research, he did not lose his leadership position. Instead, according to the first Sacramento Bee <a href="http://www.sacbee.com/2012/07/22/v-print/4648415/2-uc-davis-neurosurgeons-accused.html">article</a>,<br /><blockquote>Despite the disciplinary action imposed last fall, Muizelaar was<i> honored this spring with an additional academic role at UC Davis. He was named the first holder of the Julian R. Youmans endowed chair in the department of neurological surgery,</i> according to an April 19 news release from the UCD School of Medicine.</blockquote><br />It is not the first time he has received special treatment. The <a href="http://www.sacbee.com/2012/07/22/4648465/banned-ucd-doctor-is-one-of-ucs.html">companion article </a>noted that Dr Muizelaar was able to attain and keep his position even though he never obtained a state medical license,<br /><blockquote>Muizelaar, who previously was a professor of neurosurgery at Wayne State University in Detroit, was hired directly into the top post at UC Davis – even though<i> he lacked a California medical license.</i><br /><br />A native of the Netherlands, where he was educated, Muizelaar was brought into the UC Davis School of Medicine under a 'special faculty permit' issued by the Medical Board of California.<br /><br />The provisional permit allows a foreign doctor who has been recognized as 'academically eminent' in a specific field to practice at a sponsoring California medical school and its formally affiliated hospitals.<br /><br />Currently, only 15 doctors at six of California's eight medical schools eligible to receive them hold special faculty permits.</blockquote><br />When asked why he never bothered to obtain a California medical license<br /><blockquote>Muizelaar said he has not gotten a California license because he already works 80 to 100 hours a week and the step is 'not necessary.'<br /><br />'I'll be frank with you, <i>I'm world famous, </i>so they gave me the license to practice here,' he said. 'I can go sit for the exams, but why would I do that?'</blockquote><br />Although Dr Muizelaar continued as department chair and in his endowed professorship for approximately 10 months after he was banned from human research, things happened fast after the stories appeared in the local media. Again <a href="http://www.sacbee.com/2012/07/25/4657366/uc-davis-chancellor-orders-review.html">according to</a> the Sacramento Bee, three days later, the CEO of the UC-Davis campus, Chancellor Linda P B Katehi<br /><blockquote>ordered a top campus official to conduct a 'comprehensive review' of accusations that two university neurosurgeons conducted unauthorized research on dying brain cancer patients, as reported in Sunday's Bee.<br /><br />Ralph J. Hexter, the provost and executive vice chancellor, will lead another investigation into the actions of Dr. J. Paul Muizelaar, the longtime chairman of the department of neurological surgery, and his colleague, Dr. Rudolph J. Schrot, according to a university spokesman.</blockquote><br />A day after that, the Sacramento Bee <a href="http://www.sacbee.com/2012/07/28/4668495/uc-davis-neurosurgeon-department.html">reported</a>,<br /><blockquote>A UC Davis neurosurgeon accused of performing unauthorized research on humans has 'temporarily relinquished' his position as chairman of the department of neurological surgery, the university confirmed Friday.</blockquote><br />However, do not expect to hear much more about this,<br /><blockquote>A spokeswoman for UC Davis Health System said 'there will be no further system statement on this or other personnel actions.'</blockquote><br /><b>Summary: A Culture of Unaccountable Leadership</b><br /><br />To sum up, the highly paid chair of neurosurgery at UC-Davis performed bizarre, and potentially dangerous experiments on three patients with terminal cancer, all of whom died, without obtaining permission from the institutional review board. After internal investigation, the chair was banned from performing further human research, but kept his well-paid position, and was given a new endowed professorship. He only was forced to temporarily step down about nine months later, after reports of the affair appeared in the media. <br /><br />So, a la George Orwelll's <i><a href="http://en.wikipedia.org/wiki/Animal_Farm">Animal Farm</a></i>, doctors may think themselves as equals, but doctors who are health care leaders are more equal than others. After conduct that would likely lead to the dismissal of more ordinary doctors, those who are also in high management positions may just collect more honors. Then again, Dr Muizelaar considered himself to be "world famous," so why should be be expected to play by the rules under which the common folk labor?<br /><br />This story also suggests a more general culture of unaccountable leadership at University of California - Davis. Note that the Chancellor who let the neurosurgeon continue in his leadership role despite his strange research conduct and the consequent research ban has appeared in Health Care Renewal before. Specifically, she attained some notoriety last year after campus police who report to her pepper-sprayed unarmed and apparently non-violent students at her own institution who were protesting as part of the "occupy" movement at that time. (See post <a href="http://macadamya.blogspot.com/2012/04/will-uc-davis-chancellor-be-held.html">here</a>.) A later investigation of the incident blamed Chancellor Katehi and her subordinates for "poor decision making," and some editorialists concluded that she showed "incompetence," or worse. Yet Chancellor Katehi retains her top leadership position.<br /><br />We have discussed how leaders of other health care organizations are rarely held accountable for bad behavior by their organizations. At times, this bad behavior has been criminal, and the leaders' unaccountability has seemed more like <a href="http://macadamya.blogspot.com/search/label/impunity">impunity</a>. This seems to parallel a larger phenomenon in society. Increasingly the wealthy and powerful seem unrestricted by the rules that us common folk are expected to follow. As Charles Fergusson famously <a href="http://www.nakedcapitalism.com/2011/02/matt-stoller-a-very-political-oscars-%E2%80%93-not-a-single-executive-has-gone-to-jail.html">noted</a> on receiving his Oscar, <br /><blockquote>three years after a horrific financial crisis caused by massive fraud, not a single financial executive has gone to jail and that’s wrong</blockquote><br />Health care, particularly in the US, continues to be increasingly expensive and inaccessible, yet its quality appears increasingly dubious. True health care reform would hold health care leaders accountable for upholding the health care mission.Anonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com0tag:blogger.com,1999:blog-773490050994804177.post-42572791433703385092012-07-28T14:18:00.000-07:002012-08-15T07:28:30.342-07:00Where is the risk?That’s the question Thomas Cox, an RN with insurance experience and expertise, says should be asked about any health care financing mechanism.<br /><br />The whole idea of insurance is distributing risk widely so that it can be shared over a wide group of people and thus become manageable. That’s why people need insurance at all, and that’s also why schemes that put too much of the onus on individuals are a very bad idea – as has happened in recent years to a number of people, the “insured” individual can incur costs that are more than he or she can bear.<br /><br />In general, insurance is most solid when it’s over a larger group. Each major increase in group size distributes the risk further and makes the healthcare financing system stronger. Cox has an <a href="http://www.afn.org/~sfcommed/JSM2011PaperFinal.pdf" target="_blank">interesting paper on this</a> which he presented at an American Statistical Association meeting.<br /><br />In general, large insurers are an order-of-magnitude more sound than small ones, and nationwide insurance systems (such as Medicare) have a distinct actuarial edge over state-based insurance (think, for example, California earthquake). For this reason, it’s a shame that the Affordable Care Act (ACA) has state exchanges as its primary mechanism rather than one single federal exchange; risk dispersal is inferior. <br /><br />Looking at the risk question, there’s a real problem with affordable care organizations (ACOs), which are one of the primary ways the ACA aims to keep down future costs. Essentially, ACOs are a form of capitation, and (Cox maintains and I think he’s right) capitation is essentially a mechanism to push risks down from the insurer or from Medicare to providers. <b><i>Pushing risks to smaller groups is a terrible idea</i></b> and will worsen the system. With ACOs having smaller covered populations, they are far more subject to being the victim of events they can’t control, whether that’s having a large number of huge-cost, high-needs patients in a single year or having a large number of patients affected by an epidemic or natural disaster.<br /><br /><i><b>Providers are not trained or qualified to manage risk well, nor do they have the financial reserves to do so. </b></i>Cox calls this <a href="http://www.biomedcentral.com/1472-6939/5/3/comments" target="_blank">“professional caregiver insurance risk.”</a> Burdening providers with a task they are very ill-suited for is a truly bad idea. As Cox comments:<br /><br /><blockquote class="tr_bq">Pushing risks elsewhere removes the only real function we are paying insurance companies for. If insurance companies are pushing down their risks elsewhere, we are paying them money for nothing of value. Insurance companies don’t provide healthcare – if they don’t manage risk either, what good are they? Of course, if they can sit there and siphon off profits without taking risks, it may not trouble profit-making insurers . . . but it should trouble the public [if they are] issuing policies, passing the insurance risks on to health care providers, and walking off with guaranteed profits year after year.</blockquote><br />And (particularly for the ACO that has been “unlucky” and has incurred larger-than-expected costs), <b><i>the financial risk can be a force for corruption</i></b>, pushing organizations toward denying care and undertreatment.<br /><br />Of course, with the <u>enormous</u> amount of unnecessary care and overtreatment in the US medical system today, some ACOs may indeed manage to give really good care for quite a while provided they are reasonably lucky. But this is a strategy with diminishing returns (as unneeded care dwindles in amount). At root, pushing down insurance risk to smaller entities is, Cox has persuaded me, a fundamentally flawed direction. <br /><br />And I’ll never look at a health care financing proposal in future without asking myself: <i><b>“Where is the risk?”</b></i>Anonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com0tag:blogger.com,1999:blog-773490050994804177.post-7586140980257289612012-07-28T04:47:00.000-07:002012-08-15T07:28:30.464-07:00Productive EmploymentWith desultory interest, I picked up a 1993 novel at the library, <i>The Surgical Arena</i>, by Peter Grant, M.D., “a former navy pilot who became a surgeon.” The following snippet, on page 18, says a lot in a nutshell:<br /><blockquote class="tr_bq">“We’ve got one shot at getting into medical school and that means getting our grades into the top twenty.”<br /><br />“Why don’t we all just quit and take some gut courses that will prepare us to be brokers,” said Beckwith, one of the veterans. “We can sit on our asses and make a lot of dough.”<br /><br />“You have to be a crook to be successful in that field,” said Norman. “Besides, you’ll never get any satisfaction out of life unless you put something worthwhile back into it. I didn’t fight in the infantry to come back and become a broker.”</blockquote><br />1993 was the same year that a short-sighted Congress cancelled the Texas supercollider project. It’s <a href="http://www.salemnews.com/opinion/x1058727128/Higgs-discovery-highlights-a-missed-opportunity-here/print" target="_blank">been correctly noted</a> that had that not happened, the recent Higgs-Boson particle observation might have occurred here rather than in Switzerland. A number of the now-unemployed physicists involved were hired by Wall Street firms.<br /><br />Although basic banking DOES perform a socially useful function -- firms and individuals DO need capital -- it is very questionable what if anything “banking innovations” (CDOs, derivatives, very rapid short-term computerized trading, etc.) that have proliferated since 1993 have contributed to society. As <a href="http://www.telegraph.co.uk/finance/comment/rogerbootle/6316529/Does-banking-contribute-to-the-good-of-society.html%20%20" target="_blank">Roger Bootle wrote</a>:<br /><blockquote class="tr_bq">For m]uch of what goes on in financial markets . . . [t]he gains to one party reflect the losses to another, and the vast fees and charges racked up in the process end up being paid by Joe Public, since even if he is not directly involved in the deals, he is indirectly through the costs and charges that he pays for goods and services.</blockquote><br />In 1995, the assets of the six largest bank holding companies was no more than 17% of GDP, but at the end of 2010, the assets of the six largest bank holding companies were valued at just over 63 percent of GDP. This financialization of the economy has been <a href="http://baselinescenario.com/2012/02/29/why-is-finance-so-big/" target="_blank">at the expense of the rest of us</a>. And finance is now the top area where graduates of Ivy League universities find jobs.<br /><br />As Dale Carnegie points out, all people – even gangsters like Al Capone – think of themselves as “good guys”. Lloyd Blankfein, Goldman Sachs’ CEO, is probably sincere when he says he is “doing God’s work”. But many of us do not agree. Things work as well as they do only because many people<i> are</i> actually still working hard at useful jobs that <i>do</i> contribute to society. My thanks go to those – and not to the so-called “wealth creators.”Anonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com0tag:blogger.com,1999:blog-773490050994804177.post-45852958217515518162012-07-25T11:53:00.000-07:002012-08-15T07:28:30.584-07:00Private Equity vs Patient Care - a Bainful ExampleA long <a href="http://www.salon.com/2012/07/18/dark_side_of_a_bain_success/singleton/">investigative report</a> in Salon summarized allegations about the quality of care in various treatment centers owned by Aspen Education, and its parent company, CRC Health Group, in turn wholly owned by a private equity firm, Bain Capital. The article provides examples of what can go wrong when health care organizations are taken over by remote leadership focused overwhelmingly on short-term revenue. <br /><br /><strong>A Death from a Treatable Disease</strong><br />The report opened with the investigation of a 14 year old resident at Youth Care, in Salt Lake City, and Aspen Education treatment center. Brendan Blum "died of a twisted-bowel infaction," according to the local medical examiner, which allegedly went untreated because "two poorly paid monitors on duty," were slow to seek approval to call for emergency services, and "were too low on the totem pole to call 911 themselves."<br /><br />The article cited "previously unreported allegations of abuse and neglect in at least 10 CRC residential drug and teen care facilities across the country." It charged, "such incidents have largely escaped notice because the programs are, thanks to lax state regulations, largely unaccountable." <br /><br /><strong>Allegations of Toxic Corporate Culture</strong><br /><br />The article noted numerous other reports of unexplained and allegedly wrongful deaths, and other allegations of mistreatment of patients.<br /><br />Furthermore, the article noted allegations "that such incidents reflect, in part, a broader corporate culture at Aspen's owner, CRC Health Group, a leading national chain of treatment centers. Lawsuits and critics have claimed that CRC <em>prizes profits, and the avoidance of outside scrutiny, over the health and safety of its clients.</em>" <br /><br />We have frequently discussed how the corporate culture of the <a href="http://macadamya.blogspot.com/search/label/finance">finance industry</a>, the industry that brought us the global financial collapse/ great recession, has influenced health care, and how this culture may be related to extensive problems with the leadership of health care, including lack of understanding of or even outright <a href="http://macadamya.blogspot.com/search/label/mission-hostile%20management">hostility to the health care mission</a>, the prioritization of self-interest over the mission, <a href="http://macadamya.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a>, and even outright <a href="http://macadamya.blogspot.com/search/label/crime">criminal behavior</a>, such as <a href="http://macadamya.blogspot.com/search/label/fraud">fraud</a>, and <a href="http://macadamya.blogspot.com/search/label/kickbacks">kick-backs</a> (<a href="http://macadamya.blogspot.com/search/label/bribery">bribery</a>). One way that finance may influence health care is the presence of finance leaders on the boards of trustees of non-profit health care institutions (see recent examples <a href="http://macadamya.blogspot.com/2012/06/dartmouths-governance-and-wall-street.html">here</a> and <a href="http://macadamya.blogspot.com/2012/01/new-york-presbyterian-hospital-trustee.html">here</a>). <br /><br />A more direct way the culture of finance can influence health care is for <a href="http://macadamya.blogspot.com/search/label/private%20equity">private equity</a> firms (that is, re-branded leveraged buyout firms, look here) to purchase organizations that actually take care of patients. The Salon article noted:<br /><blockquote>CRC’s corporate culture, in turn, reflects the attitudes and financial imperatives of Bain Capital, the private equity firm founded by Mitt Romney. (The Romney campaign also did not reply to written questions.) <em>Bain is known for its relentless obsession with maximizing shareholder value and revenues.</em> Indeed, this has become a talking point of late on the Romney campaign trail; he bragged to Fox in late May that '80 percent of them [Bain investments] grew their revenues.' CRC, a fast-growing company then in the lucrative field of drug treatment, was perhaps a natural fit when Bain acquired it for $720 million in 2006. In conversations with staff and patients who spent time at CRC facilities since the takeover, there are suggestions that the Bain approach has had its effects. 'If you look at their daily profit numbers compared to what they charge,' Dana Blum [the mother of the boy who died in the incident discussed above] said of CRC’s Aspen division in 2009, 'it’s obscene.' That point, ironically enough, was underscored by the glowing reports in the trade press about its profitability.</blockquote><br />The article discussed how Bain Capital's acquisition of CRC Health Group further tilted the balance towards short-term revenue and away from quality care:<br /><blockquote>When Bain purchased CRC, it looked like an investment masterstroke. The company, founded in the mid-’90s with a single California treatment facility, the Camp Recovery Center, had quickly grown into the largest chain of for-profit drug and alcohol treatment services in the country, with $230 million in annual revenue. <em>Under Bain’s guidance, its revenue has nearly doubled, to more than $450 million.</em> CRC now serves 30,000 clients daily — mostly opiate addicts — at 140 facilities across 25 states. In the first five years after its acquisition, <em>Bain had already extracted nearly $20 million in management-related fees from the chain, </em>although Bain investors haven’t cashed in yet through dividends or an IPO. Bain’s purchase, a leveraged buyout, also saddled CRC with massive debt of well over $600 million.<br /><br />According to company executives and independent analysts, hands-on oversight of subsidiary companies is a hallmark of both Bain and CRC. Romney’s campaign literature boasts about Bain taking exactly this sort of direct role in helping to turn around failing companies. 'Over the life of an investment, they have a strong management team willing to participate,' Sheryl Skolnick, an analyst with CRT Capital, a leading institutional brokerage firm, says of Bain.<br /><br />The CRC acquisition immediately made Bain owner of the largest collection of addiction treatment facilities in the nation. Unlike some Bain Capital acquisitions, which led to massive layoffs, <em>the company’s approach with CRC was to boost revenues by gobbling up other treatment centers, raising fees, and expanding its client base through slick, aggressive marketing, while keeping staffing and other costs relatively low</em>. But that rapid pace of acquisition couldn’t be sustained in the mostly small-scale drug treatment industry alone. So Bain Capital and CRC set their sights on an entirely new treatment arena: the multibillion-dollar 'troubled teen' industry, a burgeoning field of mostly locally owned residential schools and wilderness programs then serving, nationwide, about 100,000 kids facing addiction or emotional or behavioral problems.<br /><br />One of CRC’s first acquisitions under Bain ownership was the Aspen Education Group. Founded in 1998 with about six schools, Aspen Education had expanded to 30 troubled-teen and weight-loss programs by 2006, including Youth Care of Utah. With Bain’s backing, CRC purchased Aspen for nearly $300 million in the fall of 2006.<br /><br />Less than a year later, Brendan Blum was dead.<br /><br />At the time of the CRC acquisition, <em>Aspen already had a history of abuse allegations, including at least three lawsuits, and two known patient deaths, one by suicide</em>. Featured on 'Dr. Phil,' it grew out of schools inspired by the 'tough-love' behavior-modification approach of the discredited Synanon program, which was eventually exposed as a cult. <em>By 2006, Aspen was facing a wrongful death lawsuit, later settled, </em>over an incident in 2004 in which a 14-year-old boy, Matthew Meyer, perished from heat stroke just eight days into his stay at its Lone Star Expeditions wilderness camp in Texas. </blockquote><br />This just underscores concerns we raised <a href="http://macadamya.blogspot.com/2012/01/barbarians-at-gate-making-private.html">here</a> about how ownership by private equity could undermine the ability of health care organizations to fulfill their missions. At the time we worried that private equity's short time horizon would clash with health care's long-term focus, how standardized cost-cutting approaches, including emphasis on individual employees' "productivity," could undermine patient care, and how private equity's obsession with secrecy is the antithesis of the transparency required to make health care accountable. <br /><br /><strong>The Increasing Influence of Private Equity</strong><br /><br />Ironically, the reason that the problems at CRC have gotten such public attention is that the former leader of the private equity firm that controls it is now running for the US presidency. His candidacy emphasizes just how influential the culture of private equity has come. <br /><blockquote>The purchase of CRC came seven years after [former Massachusets Governor and now Republican presidential hopeful Mitt] Romney publicly announced his retirement as CEO of Bain Capital, where he had been in charge since its founding in 1984. But at the time of his departure, Romney worked out an arrangement to continue to share in Bain’s profits as a limited partner in the firm. Today, he is still an investor in 48 Bain accounts. Though he has refused to disclose their underlying assets, some information about them can be gleaned. For example, he has reported <em>at least $300,000 to $1.2 million, if not more, in fluctuating annual earnings from Bain Capital VIII, the convoluted $3.5 billion array of related funds that owns both name-brand companies such as Dunkin’ Donuts and the lesser-known CRC Health Group.</em> Most of these funds were made more attractive to privileged investors by being registered in the Cayman Islands tax haven. And Romney’s connections to CRC run even deeper:<em> Of the three Bain managing partners who sit on CRC’s board, two, John Connaughton and Steven Barnes (with his wife), gave a total of half a million dollars to Restore Our Future, the super PAC supporting Romney. They also each donated the $2,500 maximum directly to his campaign.</em></blockquote><br />Furthermore, it provides a warning about much more influential it might become, particularly in regard to health care:<br /><blockquote>Romney has been outspoken about his belief that for-profit health care companies can flourish only without onerous regulations. 'I had the occasion of actually acquiring and trying to build health care businesses,' he said during a primary debate last year. 'I know something about it, and <em>I believe markets work. And what’s wrong with our health care system in America is that government is playing too heavy a role</em>.'</blockquote><br />The allegations against one of those health care businesses suggest another viewpoint.<br /><br />I have frequently repeated a contention that true health care reform would emphasize leadership of health care organizations that understand and uphold the values of health care, starting with prioritizing the needs of patients and the public's health over all other concerns. Instead, there is a danger that health care leaders will be ever more removed from patients and the public, and their health needs, while they become ever more concerned with making as much money as possible in the short-run, and after that, the Devil take the hindmost.Anonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com0tag:blogger.com,1999:blog-773490050994804177.post-40812353699352078732012-07-23T09:02:00.000-07:002012-08-15T07:28:30.855-07:00Health IT FDA Recall: Philips Xcelera Connect - Incomplete Information Arriving From Other SystemsAnother health IT FDA recall notice, this time on middleware, an interface engine that routes data:<br /><br /><a href="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1942-2012&w=07112012&" target="_blank">Week of July 11 </a><br /><br /><b>Product description: </b><br /><br />Philips Xcelera Connect, Software R2.1 L 1 SP2,<b> an interface engine for data exchange </b><i style="color: red;"><b>[a specialized computer and accompanying software package - ed.]</b></i><b>.</b> Philips Xcelera Connect R2.x is a generic interface and data mapping engine <b>between a Hospital Information System (HIS), Imaging Modalities, Xcelera PACS and Xcelera Cath Lab Manager (CLM)</b>. This interface engine simplifies the connection by serving as a central point for data exchange. The data consists <b>only of demographic patient information, schedules, textual information and text reports</b>.<br /><br />Classification: <b>Class II </b> <br /><br /><table border="1" class="ProductInfo"><tbody><tr><th scope="row">Reason For Recall </th><td>Xcelera Connect R2.1 L 1 SP2 ,<b> incomplete information arriving </b>from unformatted reports interface </td></tr></tbody></table><br />The data consists<b> "only"</b> of demographic patient information, schedules, textual information and text reports?<br /><br />This is a dangerous fault mode, indeed. <br /><br />"Incomplete information" moving between a hospital information system, imaging systems, a PACS system used to manage the images, and a cardiac cath lab can lead to very bad outcomes (and million dollar lawsuits), such as at "<a href="http://www.chicagotribune.com/health/ct-met-technology-errors-20110627,0,5447654.story">Babies' deaths spotlight safety risks linked to computerized systems</a>", second example.<br /><br />Note that the interface engine is in release 2.1, level 1, service pack 2.<br /><br />In other words, a critical hardware/software product such as this undergoes constant tweaking (like Windows).<br /><br />As a Class II device, at least the <a href="http://en.wikipedia.org/wiki/Medical_device#Class_II:_General_controls_with_special_controls" target="_blank">software is vetted to some degree by FDA</a>: <br /><br /><blockquote class="tr_bq">Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances.<sup class="reference" id="cite_ref-classification_7-3"><a href="http://en.wikipedia.org/wiki/Medical_device#cite_note-classification-7">[8]</a></sup><sup class="reference" id="cite_ref-controls_9-3"><a href="http://en.wikipedia.org/wiki/Medical_device#cite_note-controls-9">[10]</a></sup> In addition to complying with general controls, Class II devices are also subject to special controls.<sup class="reference" id="cite_ref-controls_9-4"><a href="http://en.wikipedia.org/wiki/Medical_device#cite_note-controls-9">[10]</a></sup> A few Class II devices are exempt from the premarket notification.<sup class="reference" id="cite_ref-controls_9-5"><a href="http://en.wikipedia.org/wiki/Medical_device#cite_note-controls-9">[10]</a></sup> Special controls may include special labeling requirements, mandatory performance standards and <a href="http://en.wikipedia.org/wiki/Postmarketing_surveillance" title="Postmarketing surveillance">postmarket surveillance</a>.<sup class="reference" id="cite_ref-controls_9-6"><a href="http://en.wikipedia.org/wiki/Medical_device#cite_note-controls-9">[10]</a></sup> Devices in Class II are held to a higher level of assurance than Class I devices, and are designed to perform as indicated without causing injury or harm to patient or user. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes.<sup class="reference" id="cite_ref-classification_7-4"><a href="http://en.wikipedia.org/wiki/Medical_device#cite_note-classification-7">[8]</a></sup><sup class="reference" id="cite_ref-controls_9-7"><a href="http://en.wikipedia.org/wiki/Medical_device#cite_note-controls-9">[10]</a></sup></blockquote><br />One wonders how testing of tweaks and updates to this product is done, if at all, other than on live and unsuspecting patients.<br /><br />When you go into the hospital you are not just putting your life in the hands of the doctors and nurses, you're putting your life into the hands of computer geeks and software development experiments.<br /><br />-- SS<br /><br />July 25, 2012 Addendum:<br /><br />The WSJ covered this here: <a href="http://blogs.wsj.com/cio/2012/07/20/philips-recalls-flawed-patient-data-system/">http://blogs.wsj.com/cio/2012/07/20/philips-recalls-flawed-patient-data-system/</a>. From their report:<br /><blockquote class="tr_bq"><br />... The problem that led to the recall: hitting the “enter” button, to start a new paragraph, in the summary field of <b>heart test reports</b>, sometimes caused the text entered below that point to be stripped from the report as it was transmitted into the patient’s electronic health record. And doctors later reviewing the patient’s electronic health record would not necessarily know they had received only part of the report, <b>which could lead them to make “incorrect treatment decisions,”</b> Philips said in a letter to hospitals.<br /><br />... Mike Davis, managing director at The Advisory Board Company, a healthcare research firm, says in the case of the Xcelera Connect, Philips should have caught the problem in testing. “How the hell does this get out? It shows there wasn’t good quality assurance processes in place.”</blockquote><br />Indeed. <br /><br />-- SSAnonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com0tag:blogger.com,1999:blog-773490050994804177.post-67167004977470159012012-07-21T04:14:00.000-07:002012-08-15T07:28:30.971-07:00Vermont: Despite $70 million investment, health IT systems a long way from prime time - "Problems are appropriate"<div style="color: red; text-align: center;"><span style="font-size: small;"><b><i>Preliminary note: This post is rich with hyperlinks. At minimum I recommend opening them in another window and at least scanning their contents - SS</i></b></span></div><br />No surprises in this article, including an amorality alien to the healing professions, but common in technology circles:<br /><blockquote class="tr_bq"><br /><span style="font-size: small;"><b><a href="http://vtdigger.org/2012/07/18/despite-70-million-investment-health-it-systems-a-long-way-from-prime-time/" target="_blank">Despite $70 million investment, health IT systems a long way from prime time</a></b></span><br />VTDigger.org<br />Andrew Nemethy<br />July 18, 2012<br /><br />The state’s efforts to digitize the world of health information, a costly multi-year endeavor that is <b>approaching a $70 million pricetag,</b> got a lousy diagnosis Tuesday.<br /><br />Instead of creating cost efficiency and improving payment flow to doctors and treatment for patients, it’s <b>creating stress and a lot of headaches for physicians</b>, according to both lawmakers and state officials overseeing the effort. <i style="color: red;"><b>[It's also creating <u>increased risk</u> for patients, a factor - the most crucial factor - rarely mentioned in articles such as this - ed.]</b></i></blockquote><br />Money, of course, grows on trees, and physicians, hospitals and government have nothing better to do with $70 million than conduct experiments on patients with alpha and beta software ... <br /><br />There's the usual excuses from the usual actors: <br /><br /><blockquote class="tr_bq">But Health Information Technology (HIT) coordinator Hunt Blair said that’s to be expected considering the difficulty of the “incredibly challenging” task of getting such disparate groups as doctors, hospitals, other health care providers, insurance companies, the state and federal government on the same digital page. </blockquote><br />Let alone (per <a href="http://www.dlib.org/dlib/january99/kling/01kling.html" target="_blank">Social Informatics</a>) the organizational and sociological challenges of implementing any new information or communications technology (ICT), that's somewhat akin to saying it's hard to get people to consume arsenic as an aphrodisiac. Not mentioned is the deplorable state of health IT in terms of quality, safety, usability, unregulated nature etc.<br /><br /><blockquote class="tr_bq">“We’re talking about an extremely complex undertaking and I think it’s important to recognize the state of Vermont was way out in front,” Blair said.<br /><br /><b>“We’re on the bleeding edge,”</b> he told a legislative Health Care Oversight Committee Tuesday at the Statehouse. <br /><br />That prompted Sen. Claire Ayer, D-Addison, the panel’s chairwoman, to ask him to clarify if he meant “leading.” <br /><br />He stuck with <b>“bleeding.”</b></blockquote><br />"Bleeding edge?"<br /><br />Aside from the very poor choice of terms, this attitude is the polar opposite of the culture of "first, do no harm." It is not a clinician's attitude. It is an attitude of someone who seems to forget that patients are at the receiving end of the "bleeding edge" (which usually implies a rocky course) technology:<br /><br /><blockquote class="tr_bq"><a href="http://en.wikipedia.org/wiki/Bleeding_edge_technology" target="_blank"><b>Bleeding edge technology</b></a> is a category of technologies incorporating those so new that they could have a <b>high risk of being unreliable </b>and lead adopters to incur greater expense in order to make use of them. The term bleeding edge was formed as an allusion to the similar terms "leading edge" and "cutting edge". It tends to imply even greater advancement, albeit at an <b>increased risk of "metaphorically cutting until bleeding" because of the unreliability of the software or other technology.</b>The phrase was originally coined in an article entitled "Rumors of the Future and the Digital Circus" by Jack Dale, published in Editor & Publisher Magazine, February 12, 1994.<a href="http://en.wikipedia.org/wiki/Bleeding_edge_technology#cite_note-0"><span></span></a></blockquote><br />Wonderful.<br /><br />Considering the risks to patients, this claim brings to mind the definition I posted of the <a href="http://macadamya.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank"><b>health IT Ddulite</b></a> ("Luddite", the common canard against cautious doctors, with the first four letters reversed):<br /><br /><blockquote><span style="font-weight: bold;"><span style="color: red; font-style: italic;">Ddulite: Hyper-enthusiastic technophiles who </span></span><span style="color: red; font-style: italic; font-weight: bold;">either deliberately ignore or are blinded to technology's downsides</span><span style="font-weight: bold;"><span style="color: red; font-style: italic;">, ethical issues, and repeated local and mass failures. </span></span></blockquote><br />On the other hand, did critic VT Sen. Kevin Mullin read my <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" target="_blank">Drexel website on health IT failure and mismanagement</a>?<br /><br /><blockquote class="tr_bq">That doesn’t surprise <b>Sen. Kevin Mullin, R-Rutland, who had tough questions</b> about the state’s effort to oversee and promote use of electronic medical health records and a statewide health information exchange.<br /><br />“I hear genuine frustration from providers who are spending time and resources trying to modernize and make their offices more efficient, and prepare for the future, <b>and yet every one of them feels like they’ve been burned,”</b> he said.<br /><br />“Basically <b>we’re not getting any results for these millions and millions of dollars that have been pumped into IT (information technology),</b>” he said after the meeting.<br /><br />“We should be a lot further along,” he said. <b>“I just don’t think the leadership’s in place.</b>”</blockquote><br />He's on the right track, but I'm not sure Vermont (or any state government) really understands what levels of leadership are truly needed, e.g., as outlined by ONC a few years ago <a href="http://macadamya.blogspot.com/2009/12/onc-defines-taxonomy-of-health-it.html" target="_blank">here</a>.<br /><br />More excuses:<br /><br /><blockquote class="tr_bq">... Mark Larson, commissioner of the Vermont Health Access Department and a former House representative from Burlington, oversees management of Vermont’s publicly funded health insurance programs and the effort on digital medical records and a new medical information exchange.<br /><br />... Larson told lawmakers he hears the same message they do, that there’s “a lot of confusion in the field.” He said that is an inevitable part of the complex process.<br /><br />“These are not systems where you just plug that in and they work perfectly on day one,” he said. <b>“Problems are appropriate along the path to get where we want."</b> <i style="color: red;"><b>[I note this is an implicit admission that experimentation is being performed - ed.]</b></i><b><br /></b><br /><br /><b>“We just have to work through that,” he said.<i> </i></b><b><br /></b></blockquote><br /><b> </b><br /><b>"Problems are appropriate?" </b>... Really?<b> In a mission critical field such as medicine? </b>That's a maddeningly reckless and cavalier ideology, to put it mildly.<b> </b>In what other safety-critical domain would such a happy-go-lucky attitude that "problems are appropriate", outside of the laboratory, be tolerated? <br /><br /><b>"We just have to work through that?" </b>... "Just work through that?" Really?<br /><br />That should be really easy, just like the failed £12.7bn (~ US $20 billion) National Programme for IT (NPfIT) in the NHS, a <a href="http://macadamya.blogspot.com/2011/09/npfit-programme-going-pffft.html" target="_blank">program that went "Pffft"</a> last year.<br /><br /><blockquote class="tr_bq">... Based on testimony Tuesday, the issues that medical practitioners and the industry face in digitizing information are <b>familiar ones for anyone who deals with technology</b>: Software that is problematic, digital files that don’t translate and can’t be read by other systems, lost time spent on technological issues that <b>detract from what doctors are paid to do</b>, <b>which is treat their patients.</b> <i style="color: red;"><b>[And create <u>increased</u> <u>risk</u> that leads to maimed or dead patients - ed.]</b></i></blockquote><br /><b>"Familiar to anyone who deals with technology?" </b>As in, say, mercantile/management computing that runs Walmart's stock inventory system, or the Post Office? Is that an <a href="http://www.nizkor.org/features/fallacies/appeal-to-common-practice.html" target="_blank">appeal to common practice</a> of some type? This brings to life my observation that there is an utter lack of recognition (either due to ignorance, or opportunism) that HIT systems are<b> not</b> business management systems<i> that happen to be used by clinicians</i>, they are virtual clinical tools (with all that implies) <i>that happen to reside on computers.</i><br /><br />How utterly amoral and <i>alien to the ethics of medicine</i> these attitudes are<i>. No regulation of the technology is in place. No systematic postmarket surveillance of patient harm or death is conducted. </i><br /><br />Further, the <a href="http://macadamya.blogspot.com/2011/02/updated-reading-list-on-health-it.html" target="_blank">literature on health IT</a> is not entirely as optimistic and tolerant as the VT government.<br /><br />Is the VT government aware of that literature?<br /><br />Just a few specific examples - the National Research Council wrote that "<span style="font-size: 100%;"><a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572" target="_parent">Current Approaches to U.S. Healthcare Information Technology are Insufficient</a>", do not support clinician cognitive processes (then what, exactly, is health IT supposed to do?) and may result in harm. </span><br /><br />The <a href="http://macadamya.blogspot.com/2012/03/ecri-institutes-top-health-technology.html" target="_blank">ECRI Institute</a> indicates health IT systems are among the top ten technology risks in healthcare.<br /><br />Reports from the <a href="http://www.jointcommission.org/assets/1/18/SEA_42.PDF" target="_blank">Joint Commission</a>, <a href="http://macadamya.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">FDA </a>and <a href="http://healthit.ahrq.gov/AppendixB_HIT_Hazard_Manager_Beta_Test.pdf" target="_blank">AHRQ</a> indicate that <b>risk is known, but magnitude of risk unknown</b> ("<a href="http://macadamya.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html" target="_blank">tip of the iceberg</a>" per FDA).<br /><br />A report from <a href="http://macadamya.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html" target="_blank">NIST</a> indicates that <b>usability is lacking</b> and promotes "<i>use error</i>" (technology-promoted error, as opposed to "<i>user</i> error").<br /><br />A report from <a href="http://macadamya.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html" target="_blank">IOM</a> on safety of health IT states that:<br /><br /><blockquote class="tr_bq">... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found <b>quantifying the magnitude of the risk.</b><br /><br />Several reasons health IT–related safety data are lacking include the <b>absence of measures and a central repository</b> (or <b>linkages</b> among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is <b>contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information</b> about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “<b>hold harmless clauses</b>”).<br /><br />The committee believes these types of contractual restrictions<b> limit transparency, which significantly contributes to the gaps in knowledge</b> of health IT–related patient safety risks. These barriers to generating evidence <b>pose unacceptable risks to safety.</b><br /><br />(Institute of Medicine, 2012. <b><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf" target="_blank">Health IT and Patient Safety: Building Safer Systems for Better Care</a></b>. PDF. Washington, DC: The National Academies Press, pg. S-2.) </blockquote><br /><a href="http://www.hhs.gov/ohrp/archive/nurcode.html" target="_blank">Human subjects protections</a>? Not needed here ... it's just one big, unconsented, happy $70 million medical experiment.<br /><br />What is not mentioned, and either deliberately ignored or lost on these politicians, is the effects of this turmoil on patient care in terms of <b>risk and adverse outcomes, and that being on the "bleeding edge" in this experimental technology is not desirable. </b><br /><br />Slow, skeptical and cautious approaches are essential.<b> Physician education on health IT risks and </b><b>patient informed consent </b><b>might be nice, too.</b><br /><br />It seems mass social re-engineering experiments are fine, even if the consequences include wasted resources the healthcare delivery system can ill afford, physicians being distracted by <a href="http://macadamya.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html" target="_blank">major defects</a>, and outcomes like <a href="http://macadamya.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html" target="_blank">baby deaths</a>, <a href="http://macadamya.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html" target="_blank">adults suffocating at the bedside</a>, and <a href="http://macadamya.blogspot.com/2011/06/my-mother-passed-away.html" target="_blank">graveyards</a>.<br /><br />-- SS<br /><br />Anonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com0tag:blogger.com,1999:blog-773490050994804177.post-51736936724684336462012-07-19T11:53:00.000-07:002012-08-15T07:28:31.081-07:00Steward Health Care vs Rhode Island Blue Cross Blue Shield: How Public Relations Twists the NarrativeNegotiations between a local RI hospital system and the largest RI health insurer have now become very public. An advertising campaign by the larger hospital system that is set to absorb our local one provides lessons on how important health care policy issues are publicly discussed. <br /><br /><strong>Simplified Background</strong><br /><br />Landmark Medical Center is a small health care system in northern Rhode Island. It has been in financial difficulty, and hence <strike>management negotiated a buyout </strike> [see comment of 19 July, 2012 below] while in receivership a buyout was negotiated. It is now in the process of being acquired by Steward Health Care, a regional hospital system based in Massachusetts (summarized <a href="http://www.beckershospitalreview.com/hospital-transactions-and-valuation/steward-healthcare-merger-with-landmark-medical-center-approved.html">here</a> and <a href="http://www.woonsocketcall.com/node/5343">here</a>). Meanwhile, Landmark has been in negotiations with Rhode Island Blue Cross Blue Shield, the largest RI health insurance company. The negotiations have not been going well, so RI BCBS notified its policy-holders that it is possible Landmark will not be in its network in the future. This difficult negotiation prompted Steward Health Care to make the discussion more public.<br /><br /><strong>The Steward Health Care Advertisements</strong><br /><br />Steward Health Care has run a series of full-page advertisements in the Providence Journal. One advertisement that has run at least three times, by my count, includes the following text:<br /><blockquote>WHAT KIND OF CHARITABLE ORGANIZATION SPENDS $120 MILLION ON ITS HEADQUARTERS<br /><span style="color: red;">BUT DENIES SERVICES TO ITS POOREST COMMUNITIES?</span><br /><br />Blue Cross & Blue Shield of Rhode Island is designated as a "charitable organization." But they certainly don't spend like one. They invested a small fortune on their opulent corporate offices in Providence. They dish out million each year in executive salaries. And for all that exorbitant spending, they pay absolutely nothing in Rhode Island state taxes.<br /><br />Then, in May of this year, they refused to give Landmark Medical Center in Woonsocket a long-term contract without Steward Health Care participating. Steward, trying to be helpful, proposed base rates that were 5% below the state median, quality metrics used by the federal government, and a commitment to payment reform. But suddenly, the coffers had run dry. Blue Cross refused to even discuss the proposal.<br /><br />Instead, they issued their response: Terminate Landmark Medical Center.<br /><br /><div class="separator" style="clear: both; text-align: center;"></div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;">Never mind the residents who would lose their only hospital, the employees who would lose their jobs, or the elderly who would have to travel for care. Blue Cross was only interested in protecting the one group they serve most effectively, themselves.</div></blockquote><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;"><br /></div><div class="separator" style="clear: both; text-align: center;"><a href="http://3.bp.blogspot.com/-RzQJl_tXOuQ/UAhVt48sklI/AAAAAAAAAE4/gBocsYzpYp8/s1600/StewardBCBSAdvertisement%25280712%2529.gif" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" hda="true" height="225" src="http://3.bp.blogspot.com/-RzQJl_tXOuQ/UAhVt48sklI/AAAAAAAAAE4/gBocsYzpYp8/s320/StewardBCBSAdvertisement%25280712%2529.gif" width="320" /></a></div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;"><br /></div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;"><br /></div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;">This pretty plainly was a David vs Goliath narrative, with poor, small Landmark Medical Center and Steward Health Care, whose only goals were to serve local residents, as David, and huge, wealthy Blue Cross Blue Shield of RI, whose only goal is allegedly to serve its executives' interest, as Goliath.</div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;"><br /></div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none;">Given that we have frequently discussed how self-interested, <a href="http://macadamya.blogspot.com/search/label/executive%20compensation">over-compensated</a> executives may fail to uphold, or may even <a href="http://macadamya.blogspot.com/search/label/mission-hostile%20management">undermine their health care organizations' missions</a>, this seemed like a narrative primed for further discussion on Health Care Renewal. In addition, Blue Cross Blue Shield of Rhode Island was beset by a scandal before we began Health Care Renewal (look <a href="http://macadamya.blogspot.com/2004/12/mismanagement-are-us.html">here</a>), involving allegations of excess compensation given to and conflicts of interest affecting its CEO.</div><br /><strong>Blue Cross Blue Shield of RI: Executive Compensation, Budget and Taxes</strong><br /><br />In fact, the most recent figures made public by RI BCBS on executive compensation showed that CEO Peter Andruszkiewicz was offered total compensation of $600,000 a year when he started in 2011 (look <a href="http://blogs.wpri.com/2011/04/26/new-blue-cross-ri-ceo-will-earn-600000-a-year/">here</a>.) Also, as suggested by the advertisement above, there has been considerable local controversy about the size, scale, and price of the new RI BCBS headquarters (e.g., <a href="http://evantrowbridge.com/2010/07/21/bill-lynch-condemns-blue-cross-blue-shield-for-layoffs/">here</a>). Apparently, however, Blue Cross Blue Shield of Rhode Island does pay state taxes (per <a href="http://www.publicbroadcasting.net/wrni/news.newsmain/article/0/0/1801809/Healthcare/RI.Blue.Cross.Blue.Shield.seeks.rate.increase">this report</a>).<br /><br />On the other hand, keep in mind that RI BCBS is one of the few health insurance companies to provide community (age-adjusted only) rated individual health insurance even for people with pre-existing conditions, (look <a href="https://www.bcbsri.com/shop-for-plan/plan-medical/individuals?order=title&sort=asc">here</a>) at the behest of state law, to be sure. So perhaps RI BCBS is not quite the ogre oppressing the poor that the advertisement implies it to be. <br /><br />But wait, there is more. This all started as a contract negotiation between a health insurer and a local hospital system which is about to be acquired by a regional hospital system. If Steward Health Care saw fit to bring up the executive compensation practices, budget, and taxes of Blue Cross Blue Shield of Rhode Island as relevant to the dispute, might Steward Health Care's executive compensation practices, budget, and taxes also be relevant?<br /><br /><strong>Steward Health Care and Cerberus Capital Management: Executive Compensation, Budget, and Taxes</strong><br /><br />The problem is that we know very little about Steward Health Care's executive compensation practices, budget, and taxes. While the advertisement above (and Steward's own web address, steward.org) imply that Steward is only about providing health care to the poor and needy, and perhaps that Steward, like Rhode Island BCBS, is non-profit, neither is quite true.<br /><br />In fact, Steward Health Care is the new name for what was once Caritas Christi Health Care, formerly a Catholic non-profit health system that was acquired in 2010 by Cerberus Capital Management, a private equity firm (look <a href="http://steward.org/news/Caritas-Christi/Acquisition-of-Caritas-Christi-Now-Complete">here</a>).<br /><br />Private equity firms are notably secretive. Neither Cerberus, nor its new health care acquisition, has seen fit to publish any details about executive compensation practices, budgets, or taxes. <br /><br />We do have a few clues, however.<br /><br /><u>Executive Compensation</u><br />Caritas Christi at the time it was acquired by Cerberus was lead by CEO Ralph de la Torre. His compensation in 2009 prior to the acquisition was $2.2 million a year. He is still leading Steward Health Care. It is reasonable to expect that his compensation is not less than it was before, and probably more (look <a href="http://macadamya.blogspot.com/2011/11/ceos-first-to-benefit-from-for-profit.html">here</a>). It is reasonable to guess that Dr de la Torre's total compensation is currently several times larger than that of the BCBS of RI CEO. <br /><br />The leadership of Cerberus Capital Management includes, according to<a href="http://www.cerberuscapital.com/team/senior_executive_leadership"> its web-site</a>, John W Snow, chairman and senior managing director. Mr Snow, former Secretary of the US Treasury, was listed in 2009 on the <a href="http://www.virginiabusiness.com/index.php/news/article/the-virginia-100/">Virginia 100 web-site</a> as having a net worth of approximately $90 million, although not with much confidence in the precision of the figure. He is also a director of the Marathon Petroleum Corporation, from which he received $300,000 in compensation in 2011, according to the company's <a href="http://www.marathonpetroleum.com/content/documents/investor_center/annual_reports/2011ProxyStatement.pdf">proxy statement</a>, and of Amerigroup, from which he received at least $170,000 in equities, and additional amounts in fees and deferred compensation in 2011, per that company's <a href="http://services.corporate-ir.net/SEC/Document.Service?id=P3VybD1odHRwOi8vaXIuaW50Lndlc3RsYXdidXNpbmVzcy5jb20vZG9jdW1lbnQvdjEvMDAwMTE5MzEyNS0xMi0xODY2MDEvZG9jL0FNRVJJR1JPVVBDb3Jwb3JhdGlvbl9ERUYxNEFfMjAxMjA0MjcucGRmJnR5cGU9MiZmbj1BTUVSSUdST1VQQ29ycG9yYXRpb25fREVGMTRBXzIwMTIwNDI3LnBkZg==">proxy statement</a>. Stephen A Feinberg, founder, CEO, and senior managing director, <a href="http://dealbook.nytimes.com/2008/04/15/cerberus-recluse-lifts-the-veil-a-little/">described</a> as a "recluse" in the New York Times, was listed as number 21 on a list of the 25 most powerful businessmen in 2007 <a href="http://money.cnn.com/galleries/2007/fortune/0711/gallery.power_25.fortune/21.html">by Fortune</a>, at that time running through Cerberus 50 companies with total revenues of $120 billion. <a href="http://en.wikipedia.org/wiki/Steve_Feinberg">On Wikipedia</a>, his net worth was estimated as $2 billion in 2008. These figures suggest that leaders of Cerberus Capital Management can make very large amounts of money, orders of magnitude larger than the compensation of the BCBS of RI CEO.<br /><br /><u>Budget</u><br />There is little public information on the budget of Cerberus Capital Management, but note again the estimate above that in 2007, it controlled 50 companies with $120 billion in revenues. There is also little public information about the budget of its subsidiary, Steward Health Care. Estimates from a recent <a href="http://www.commonwealthmagazine.org/News-and-Features/Features/2012/Summer/001-Cerberuss-health-care-play.aspx">article</a> in Commonwealth suggested that Cerberus invested $251.5 million in Steward, but that Steward's 2011 budget had a net loss of $57 million. <a href="http://www.woonsocketcall.com/node/5343">According to the Woonsocket Call</a>, an apparently short-term balance sheet from March 31, 2012 showed that Steward Health Care had assets of $1.1279 billion, liabilities of $1.0259 billion, and stockholder equity of $102 million.<br /><br /><u>Taxes</u><br />There seems to be no significant public information on taxes paid by Steward Health Care or Cerberus Capital Management. According to Chareles Ferguson in <a href="http://www.randomhouse.com/book/213722/predator-nation-by-charles-h-ferguson"><em>Predator Nation</em></a>, Cerberus chairman John W Snow resigned as Treasury Secretary "in 2006 only because it was revealed that he had not paid any taxes on $24 million in income from CSX, which had forgiven Snow's repayment of a gigantic loan that the company had made to him."<br /><br />So while RI BCBS can be faulted for paying relatively high executive compensation, using its funds to build a rather lavish headquarters building, but not for failing to pay RI taxes, at least all these have been issues for public discussion. Furthermore, Cerberus Capital Management, and Steward Health Care which is its creature, while explicitly bringing these issues into the public debate about the Landmark negotiation with Blue Cross Blue Shield of RI, have not seen fit to reveal their own executive compensation, budget, or taxes. There is reason to think that their executive compensation and management budgets could be far more bloated that those of RI BCBS. We have no idea whether they have paid what might be considered their fair share of taxes, but note that their current chairman has had issues in the past with his personal tax payments. <br /><br /><strong>Summary</strong><br /><br />The vigorous advertising/ public relations campaign by Landmark Medical Center, Steward Health Care, and ultimately Cerberus Capital Management to get a more successful outcome of the negotiation between Landmark and RI BCBS seems to be an example of the tactics used in support of the public relations by large, for-profit health care organizations. In the absence of any transparency about the executive compensation, budget, and tax payments by Cerberus Capital Management and its subsidiary, Steward Health Care, lavish public advertising faulting the executive compensation, budget, and tax payments of its counter-party suggests a rather crude attempt to twist the narrative so as to divert public attention from relevant issues. <br /><br />If this was not the intention, perhaps Cerberus and Steward will make their executive compensation, budgets, and tax returns fully transparent? We wait with bated breath.<br /><br />In the absence of such transparency, skepticism about their public discourse remains warranted.<br /><br />There is more and more public discussion of health policy from the local to the global levels. Much of this discussion, like much political discussion in general, seems dominated by expensive public relations efforts on behalf of the richer health care organizations. Physicians, other health care professionals, health policy researchers and leaders, and the public at large should be alert to the possibility that these communications will use psychological manipulation to divert its narratives in directions favored by these large health care organizations. Anyone listening or viewing communications coming out of such public relations efforts ought to consciously think about the relevant facts and issues they ignore, and why they may have been consciously omitted.Anonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com2tag:blogger.com,1999:blog-773490050994804177.post-69275689791934346262012-07-16T05:55:00.000-07:002012-08-15T07:28:31.187-07:00University of Virginia, GE settle $47M suit over EMR implementation<div style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;">The following <a href="http://en.wikipedia.org/wiki/Keystone_Cops" target="_blank">Keystone Kops</a> story of healthcare IT dysfunction <i>brings to life</i> (</span><span style="font-size: small;">like the old GE slogan) </span><span style="font-size: small;">the types of mismanagement I've written about at my site "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" target="_blank">Common Examples of Healthcare IT Difficulties</a>":</span><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="http://2.bp.blogspot.com/-e61xHyBDJNY/UAQX5l7OX3I/AAAAAAAAA5A/9WL42wvUhOw/s1600/ge.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="215" src="http://2.bp.blogspot.com/-e61xHyBDJNY/UAQX5l7OX3I/AAAAAAAAA5A/9WL42wvUhOw/s320/ge.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="font-size: x-small;">From 1982 <a href="http://www.youtube.com/watch?v=w3PXucLotXk" target="_blank">GE commercial</a> - "We Bring Good Things to Life"</span></td></tr></tbody></table></div><table border="0" cellpadding="0" cellspacing="0" style="font-family: Arial,Helvetica,sans-serif;"><tbody><tr><td width="31"><br /></td><td style="color: #888888;" valign="bottom" width="150"><br /></td><td style="color: #888888;" valign="bottom"><br /></td></tr></tbody></table><div style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;">Clown pun not intentional - but perhaps apropos, not just with reference to GE but to U. Va's health IT leadership team as well. It seems both parties might have had a role in this debacle (see additional links in the article below).</span></div><br /><blockquote class="tr_bq"><div style="font-family: Arial,Helvetica,sans-serif;"><a href="http://www.fierceemr.com/story/university-virginia-ge-settle-47-million-suit-over-emr-implementation/2012-07-13" target="_blank"><span style="font-size: small;">University of Virginia, GE settle $47M suit over EMR implementation</span></a></div><div style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;">FierceEMR.com<br />July 13, 2012</span></div><div style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;">By Dan Bowman</span></div><div style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;"><br /></span></div></blockquote><table border="0" cellpadding="0" cellspacing="0" style="font-family: Arial,Helvetica,sans-serif;"><tbody><tr><td><blockquote><span style="color: black; font-size: small;"><span style="background-color: transparent; color: black;">The University of Virginia this week reportedly has settled a $47 million civil suit against GE Healthcare over <b>what it believes was sloppy--and ultimately incomplete--development and implementation of an electronic medical record system.</b> The case, which originally was filed in 2009, had been set to go to trial this week. When <i>FierceHealthIT</i> checked on Friday, the case had yet to be entered into the circuit court clerk's records.<br /><br /> In 1999, UVa hired IDX Systems Corporation to develop an integrated healthcare information management system, <a href="http://links.mkt1985.com/ctt?kn=111&ms=NDIwOTU3NwS2&r=MTg5MTY1NTQxNjMS1&b=0&j=MTI3NzcwMzAyS0&mt=1&rt=0" name="13888ff9baf6844c_www2_dailyprogress_com_ne_ojbtUcKYEdHkW8fhhvBA" target="_blank" title="http://links.mkt1985.com/ctt?kn=111&ms=NDIwOTU3NwS2&r=MTg5MTY1NTQxNjMS1&b=0&j=MTI3NzcwMzAyS0&mt=1&rt=0">according to</a> <i>The Daily Progress</i>. Amendments to the contract in 2002 divided the project into four phases, with the<b> first two focusing on implementation of the records management software,</b> and the last two focusing on billing and logistics.<br /><br /> After acquiring IDX in 2006, GE was tasked with hitting the milestones <b>outlined through Phase 2 </b>by June 2008; UVa claims it never did, and in February 2009 asked for a refund of more than $20 million. At that time, UVa also awarded a $60 million contract to Epic to perform the same tasks, <a href="http://links.mkt1985.com/ctt?kn=88&ms=NDIwOTU3NwS2&r=MTg5MTY1NTQxNjMS1&b=0&j=MTI3NzcwMzAyS0&mt=1&rt=0" name="13888ff9baf6844c_c_ville_com_Article_UVA_U_pJZwjnBkM2Ve8wKqxP6EA" target="_blank" title="http://links.mkt1985.com/ctt?kn=88&ms=NDIwOTU3NwS2&r=MTg5MTY1NTQxNjMS1&b=0&j=MTI3NzcwMzAyS0&mt=1&rt=0">according to</a> <i>C-Ville.com</i> [see note 1].<br /><br /> GE swiped back, blaming UVa for the delays in implementation, and saying that by going with Epic, the school "failed to perform its obligations under the agreement, breaching its contract," according to a filing obtained by the <i>Daily Progress</i>.<br /><br /> The case isn't too surprising, considering that <a href="http://links.mkt1985.com/ctt?kn=135&ms=NDIwOTU3NwS2&r=MTg5MTY1NTQxNjMS1&b=0&j=MTI3NzcwMzAyS0&mt=1&rt=0" name="13888ff9baf6844c_fierceemr_com_story_klas__X16Dr3aQkEYX6712RPz2w" target="_blank" title="http://links.mkt1985.com/ctt?kn=135&ms=NDIwOTU3NwS2&r=MTg5MTY1NTQxNjMS1&b=0&j=MTI3NzcwMzAyS0&mt=1&rt=0">GE Healthcare has had issues since purchasing IDX</a>. In a KLAS report from August 2010, author Kent Gale said there was a "downward trend in GE's meeting commitments" to its customers.</span></span></blockquote><span style="color: black; font-size: small;"><span style="background-color: transparent; color: black;"><br />Besides what was undoubtedly a huge waste of money and resources, what is missing from this story is the possible impact of this debacle on <b>patient care</b>. Not "hitting the milestones" of phase 1 and 2 ("<span style="color: black; font-size: small;"><span style="background-color: transparent; color: black;">focusing on implementation of the records management software") and peforming "sloppy and incomplete" work can probably be translated as having had "bull in a china shop" effects on records management.</span></span><br /><br />Perhaps the <b>morbidity and mortality rates at U. Va </b>during the period of EHR mayhem need to be examined.</span></span><br /><span style="color: black; font-size: small;"><span style="background-color: transparent; color: black;"><br /></span></span><br /><span style="color: black; font-size: small;"><span style="background-color: transparent; color: black;">-- SS</span></span><br /><br /><span style="color: black; font-size: x-small;"><span style="background-color: transparent; color: black;">Notes:</span></span><br /><br /><span style="color: black; font-size: x-small;"><span style="background-color: transparent; color: black;">[1] From the link to C-Ville.com: "</span></span><i><span style="font-size: x-small;">According to UVA’s complaint, the deal dates to 1999, when UVA contracted with tech firm IDX to develop an electronic medical record system, or EMR, for its hospital. But problems started early, UVA claimed, with IDX failing to hit milestones on the multi-phase project. When technology company GE took over IDX in 2006, the parties got together to rework the contract. But UVA said the issues continued, and it ultimately pulled the plug, saying GE failed to meet its obligations. GE, meanwhile, claimed it was UVA that broke contract. The two parties had agreed to work together on the complicated project, according to the company’s counterclaim. UVA was to act as a development partner, collecting and processing two decades’ worth of patient data and building and testing the system. But the medical center didn’t hold up its end of the bargain, said GE, making it impossible for the company to stay on schedule."</span></i><br /><br /><br /><span style="font-size: x-small;"></span><span style="color: black; font-size: small;"><span style="background-color: transparent; color: black;"> </span></span></td></tr></tbody></table>Anonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com0tag:blogger.com,1999:blog-773490050994804177.post-34160274002204548992012-07-15T07:12:00.000-07:002012-08-15T07:13:49.728-07:00About<div style="text-align: justify;"><span style="font-style: italic; font-weight: bold;">Health care</span> is the diagnosis, treatment, and prevention of disease, illness, injury, and other physical and mental impairments in humans. Health care is delivered by practitioners in medicine, chiropractic, dentistry, nursing, pharmacy, allied health, and other care providers.<br /><br /><span style="font-style: italic; font-weight: bold;">Descriptions of Health Care</span><br /><br />Universal health care, health care insurance, national health care, free health care, health care coverage, health care problems.</div>Anonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com0tag:blogger.com,1999:blog-773490050994804177.post-53618568940709401832012-07-13T06:43:00.000-07:002012-08-15T07:28:31.294-07:00Did Toxic Effects of an EHR Kill Rory Staunton?A stunning story about the death of a young man from sepsis (blood poisoning by infection), missed in an ED, appeared in the New York Times:<br /><br /><blockquote class="tr_bq"><b><a href="http://www.nytimes.com/2012/07/12/nyregion/in-rory-stauntons-fight-for-his-life-signs-that-went-unheeded.html" target="_blank">An Infection, Unnoticed, Turns Unstoppable</a></b><br /><br />By JIM DWYER<br />New York Times<br />Published: July 11, 2012<br /><br />For a moment, an emergency room doctor stepped away from the scrum of people working on Rory Staunton, 12, and spoke to his parents. <br /><br />“Your son is seriously ill,” the doctor said.<br /><br />“How seriously?” Rory’s mother, Orlaith Staunton, asked.<br /><br />The doctor paused.<br /><br />“Gravely ill,” he said.<br /><br />How could that be?<br /><br />Two days earlier, diving for a basketball at his school gym, Rory had cut his arm. He arrived at his pediatrician’s office the next day, Thursday, March 29, vomiting, feverish and with pain in his leg. He was sent to the emergency room at NYU Langone Medical Center. The doctors agreed: He was suffering from an upset stomach and dehydration. He was given fluids, told to take Tylenol, and sent home.<br /><br />Partially camouflaged by ordinary childhood woes, Rory’s condition was, in fact, already dire. Bacteria had gotten into his blood, probably through the cut on his arm. He was sliding into a septic crisis, an avalanche of immune responses to infection from which he would not escape. On April 1, <b>three nights after he was sent home from the emergency room, he died in the intensive care unit.</b> The cause was <b>severe septic shock</b> brought on by the infection, hospital records say. </blockquote><br />Rory Staunton, age 12, 5 feet 9 inches tall and 169 pounds, had suffered a cut on his arm. He presented with a marked fever of 102 F (39 C), pulse markedly elevated at 131, respiratory rate elevated at 22; reported to have hit as high as 36 breaths per minute (in essence, panting). It was reported by the NYT that before the ED visit his parents said his temperature had reached 104 F (40 C).<br /><br />That alone should have set off some level of concern. (It is possible narrative details of his history never made it into the ED chart; ED EHR's are often templated point-and-click affairs that can impair or discourage capture of narrative.)<br /><br />Per the NYT, the bacteria <a href="http://pyogenesgonewild.com/">Streptococcus pyogenes</a> normally dwells in the throat or on the skin, areas where the body is well defended. Also known as Group A streptococcus, the strain typically causes strep throat or impetigo. However, if it gets into the blood stream (e.g., via a cut in the skin, as this patient suffered playing ball), the results can be devastating.<br /><br />The lab results from the first ED visit are <i>particularly</i> stunning:<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="http://3.bp.blogspot.com/-g2y3KPXi2Lk/UAAc4zFXNNI/AAAAAAAAA4g/ofKduygo-EU/s1600/labs.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="395" src="http://3.bp.blogspot.com/-g2y3KPXi2Lk/UAAc4zFXNNI/AAAAAAAAA4g/ofKduygo-EU/s400/labs.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">(From NYT article; click to enlarge)</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 />The white blood cell count is markedly elevated at 14.7, meaning 14,700 cells per microliter of blood (cubic millimeter or 1 mm<sup>3</sup>). Further, there is a plain evidence of greatly accelerated new white cell production, in the form of <b>"bands"</b>, at <b>53% </b>of the total (normally 5-15%). <b><b>Bands</b> </b>are immature white blood cells that are seen in the blood, being produced as part of the body's response to infection.<br /><br />Herein is a significant issue. The NYT noted that:<br /><br /><blockquote class="tr_bq">"Three hours later <i style="color: red;"><b>[i.e., after the ED visit, which reportedly only lasted 2 hours - ed.]</b></i>, Rory’s blood tests came back. High levels of neutrophils and “bands” – immature white blood cells – are evidence of infection. <b>But nobody called the Stauntons, and by the time Rory returned to the hospital the next day, his infection was unstoppable. He died two days later.</b>"</blockquote><br />Not getting into the issue regarding the patient apparently being discharged before the labs got back (itself an invitation to disaster), and the other abnormalities such as low sodium, low platelets, elevated glucose all pointing to a very sick patient... <b>nobody called the Stantons with white cell results like these? </b>Nobody entertained the thought of ...<b> antibiotics as a precaution?</b><br /><br />It is possible - dare I say likely - that no clinical person in the ED ever saw these results.<br /><br />EHR's that are poorly designed or implemented can have a toxic effect on care. For instance, EHR's can cause user confusion if the user interface is complex, data can be lost due to poor relational design. Data from the wrong patient's data can be presented (misidentification), or data from a lab can come back to the system after a patient has left, and despite being abnormal, <b>just sit there in a silo without being looked at ("out of sight, out of mind"; a "silent silo" syndrome).</b><br /><br />It is usually difficult to ascertain exactly which EHR product is being used at a particular hospital. I note this medical center actively promoted its EPIC EHR<b> </b>in a June 2011 press release "<a href="http://communications.med.nyu.edu/media-relations/news/nyu-langone-medical-center-launches-next-phase-its-electronic-health-record-sys" target="_blank">NYU Langone Medical Center Launches Next Phase of Its Electronic Health Record System</a>", although another system "ICIS" (for <i>Integrated Clinical Information System</i>, "<i>a state-of-the-art healthcare information management system that connects all NYULMC caregivers involved in patient care</i>") is mentioned <a href="http://icis.med.nyu.edu/about/whatis.html" target="_blank">here</a>. The ICIS may also contain the Eclipsys Sunrise Clinical Manager, per <a href="http://icis.med.nyu.edu/about/history.html" target="_blank">this link</a>. (I'd noted some clinically relevant problems with the latter in an FDA report <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=1729552" target="_blank">here</a>.)<br /><br />In any case, magical powers are attributed to the technology that are not strongly or uniformly supported by the literature (<a href="http://macadamya.blogspot.com/2011/02/updated-reading-list-on-health-it.html" target="_blank">link</a>), but strongly pushed by industry marketing memes of deterministic health IT benefits and absolute beneficence:<br /><br /><blockquote class="tr_bq">“... Our electronic health record system is an integral part of our ongoing efforts to leverage technology and enhance our ability to provide patient-centered care and enable the highest level of quality care management,” said Bernard A. Birnbaum, MD, senior vice president and vice dean, chief of hospital operations at NYU Langone. “These front-end and back-end services are an important step in assuring our patient’s experience from beginning to end is a seamless one.”</blockquote><br />I've documented examples of situations where EHR's and other IT components of clinical ERP systems <i>(enterprise resource planning and management systems, a term that more accurately describes what exists in many hospitals now than the misleading, file cabinet-evoking term "EHR")</i> contributed to or caused patient harm, such as at "<a href="http://macadamya.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html" target="_blank">Babies' deaths spotlight safety risks linked to computerized systems</a>" - a computer error caused a central line placement x-ray to have gone unread, leading to death; "<a href="http://macadamya.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html" target="_blank">The Sweet death that wasn't very sweet</a>" - a missing "difficult intubation" EHR flag led to a middle-aged man suffocating during an intubation attempt; and others. An Australian researcher thoroughly studied the potential risks of an EHR meant specifically for ED's ("<a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146" target="_blank">A Study of an Enterprise Health information System</a>", PDF executive summary <a href="http://sydney.edu.au/engineering/it/%7Ehitru/essays/Pt%200%20-%20Executive%20Summary.pdf" target="_blank">at this link</a>).<br /><br />The following passage in the NYT article also offers another clue:<br /><br /><blockquote class="tr_bq">... Two hours later, though, he had three [signs of sepsis]: his temperature had risen to 102, his pulse was 131 and his respiration rate was 22. But by the time those vital signs were recorded, at 9:26 p.m., they had no bearing on his treatment. In fact, the doctor had already decided that Rory was going home. <b>Rory’s “ExitCare” instructions, signed by his father, were printed 12 minutes before those readings. </b></blockquote><br />Did those readings escape notice due to delayed charting (data entry), a common problem with EHRs in busy clinical environments?<br /><br />The Institute of Medicine in its 2011 <b>IOM report on health IT safety</b> admitted harms are reported but the magnitude of harms is unknown due to multiple reporting impediments, as did the FDA in its 2010 <b>internal memo on "H-IT Safety Issues"</b> divulged by the Huffington Post Investigative Fund (see <a href="http://macadamya.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html" target="_blank">here</a> and <a href="http://macadamya.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">here</a>). The National Institute of Standards and Technology (NIST) admits in its <b>2011 report on HIT usability</b> that EHR usability is often poor and may lead to "use error" (error caused or promoted by poor design, as distinguished from simple user error, see <a href="http://macadamya.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html" target="_blank">here</a>), magnitude of problem also unknown.<br /><br />In a startling medical situation such as Rory Stanton's, where crucial labs seem to have evaporated causing or contributing to delayed treatment of a devastating and obvious illness, <b>I believe EHR-related factors need to be examined and ruled out <u>first</u>.</b><br /><br />For, quite simply, if the EHR caused or contributed to this tragic debacle, <i>the public could be at risk</i>. <b><br /></b><br /><br />-- SS<br /><br />Additional thought: could this be the "cybernetic <a href="http://en.wikipedia.org/wiki/Libby_Zion_law" target="_blank">Libby Zion</a> case" I've written of?<br /><br />-- SS<br /><br /><b>July 18, 2012 Addendum:</b><br /><br />The Stauntons, who appeared on the NBC Today Show are seeking to create a “Rory’s Law” in New York to ensure that parents have full access to blood and lab tests done on their children as soon as results are available, and that a doctor will be present to assess the findings. Story <a href="http://www.irishcentral.com/news/Rorys-Law---major-effort-underway-to-ensure-kids-kept-safe-in-ER-162842926.html" target="_blank">here</a>.<br /><br />-- SS <br />Anonymoushttp://www.blogger.com/profile/11444083499013073710noreply@blogger.com0