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Hospital Executives - What Will They Think of Next?

Health care organizations are now most often run by people with management, not clinical backgrounds.  It seems like business schools have taught managers to sign on to whatever the latest management fashions are.  So what are the latest fashions in hospital management?  Here are a few hot items. Retreading Pharmaceutical Representatives My jaundiced reading of the business news suggests that most executives think that marketing is the most important part of their organizations, and that clever marketing can sell any product or service. For example, the pharmaceutical industry spends about twice as much on marketing as it does on research and development (despite pharma executives' protestations that they run research driven businesses) (see <a href="http://hcrenewal.blogspot.com/2008/01/blogscan-575-billion-spent-yearly-on.html">this post</a>). So it should be no surprise that now hospitals are using "hospital representatives" to market referrals to their institutions to doctors. From <a href="http://www.usatoday.com/money/industries/health/story/2011-12-13/hospitals-sales-reps/51887938/1">last week's USA Today</a>: <blockquote>n northwest Indiana, Carrie Sota visits five or six doctors' offices every workday as part of her new sales job. But Sota isn't selling the physicians on a prescription drug or a medical device. She's promoting her hospital — the University of Chicago Medical Center. Sota, 30, is one of four employees the academic medical center has hired in recent months to make 'sales calls' on physicians in the hope that they will send more patients to the hospital. 'We are trying to build meaningful relationships,' said Sota, who was previously a saleswoman for a small medical device company. The University of Chicago Medical Center is one of a growing number of hospitals nationwide hiring former drug and device sales reps to visit doctors' offices to persuade them to use their services over competing facilities. Rather than handing out samples of prescription drugs, the sales reps call on doctors armed with the latest information on how their facility is reducing hospital-acquired infections and improving patient-satisfaction scores. In visits that can last five to 20 minutes, reps try to win doctors' loyalty by helping them get better times on operating room schedules or easier patient referrals to hospital-based specialists. The sales reps can also carry messages back to the hospital, such as a doctor's request for a new medical device to be available in surgery.</blockquote> The article suggested a few problems with this approach. First, the point of the marketing is not to improve the match between patients' needs and the services the hospital provides. Rather, it is to generate referrals that have the potential to provide the maximum revenue: <blockquote>While hospitals have always tried to woo doctors to refer patients to them, the institutions are growing more direct in their efforts. The hospitals mine data to see which doctors have the most profitable, well-insured patients, and then they assign those doctors to a sales rep.</blockquote> So in particular, <blockquote>Many of the physician liaisons focus on specialists, who bring in patients for services with the highest profit margins, including orthopedics, cardiac care and cancer care, [Duke University Health System physician liaison manager Christine] Perry said.</blockquote> Second, the hospital reps have incentives based on revenue, not on value to the patient: <blockquote>About two-thirds of Tenet's liaisons are former drug and device sales reps, and they can make tens of thousands of dollars in bonuses if doctors increase their referrals to the hospitals. </blockquote> Third, across the system, the revenues generated may be much less than the costs incurred, since most of the marketing will only succeed in moving patients from one hospital to another: <blockquote>Paul Ginsburg, president of the non-partisan Center for Studying Health System Change, said, 'When you look at the health system, this is a waste of resources. It's a zero-sum game.' He added: 'The net results of changing physician-referral patterns is that one hospital gains at a cost of others, and all the hospitals burn resources to pay (sales)people who take up the doctor's time.'</blockquote> Of course, the reps could succeed in persuading doctors to refer patients to specific hospitals for services the doctors originally did not think the patients needed. That would be good were the patients to need those services, but bad if they were not. Fourth, we have discussed (for example, <a href="http://hcrenewal.blogspot.com/2007/05/fool-me-once-shame-on-you-fool-me-twice.html">here</a> and <a href="http://hcrenewal.blogspot.com/2008/04/more-about-cynical-world-of-drug-reps.html">here</a>) how pharmaceutical representatives use sophisticated psychological and emotional manipulation, despite claims that all they do is provide unbiased information and educational, to influence physicians to prescribe drugs. Again, this may result in patients getting drugs whose benefits do not outweigh their harms. It is possible that hospital representatives will do something similar: <blockquote>'These people are really good and really assertive and very sophisticated,' said Stephen Newman, Tenet's chief operating officer.</blockquote> Unbundling Payments The airlines decided a while ago that they could make more money by charging passengers for each checked bag, and even for those little meals on plastic trays. It looks like hospital executives have discovered a new way to unbundle. As reported last month by <a href="http://www.stltoday.com/business/local/outpatient-sticker-shock-for-a--minute-treatment/article_a2915e64-1499-11e1-bf45-001a4bcf6878.html">the St Louis Post-Dispatch</a>, hospitals have begun charging often hefty "facility fees" for patients seen as outpatients in hospital clinics or hospital owned practices, even for very minor procedures or just office visits, and even for Medicare patients. (Private physicians who see patients in their own offices cannot charge such fees to Medicare patients, and most private insurance companies will not cover such fees.): <blockquote>A few weeks after Allison Zaromb took her 4-year-old son Meir to see a dermatologist in an outpatient office at the SSM Cardinal Glennon Children's Medical Center campus, she received separate bills from the doctor and the hospital. The cost for a 3-minute procedure to treat Meir's warts totaled $538, which included a $220 bill for physician services - and a separate bill for a $318 hospital 'facility fee.' Zaromb, a periodontist who lives in University City, is now suing SSM Health Care Corp. and Cardinal Glennon Children's Medical Center in a proposed class action lawsuit on behalf of other patients</blockquote> More generally, <blockquote>With the proliferation of hospital-owned outpatient centers and hospital-owned physician practices, hospital 'facility fees' have become increasingly common. Such hospital facility fees often involve greater dollar amounts than the fees charged by physicians.</blockquote> Technically, it all appears to be legal: <blockquote>Under federal regulations, health systems are permitted to charge a hospital facility fee for an outpatient service if it's done in a clinic that is 'hospital-based' - meaning that the clinic is owned and operated as part of a hospital or health system, regardless of whether the clinic is physically located on the hospital grounds.</blockquote> This technique does seem to be a way to increase revenue. But one person's revenue is another person's cost, so it also seems to be a great way to further increase the already high cost of US health care. It is not obvious, however, that these increased costs will lead to increased quality of care or value for the patient: <blockquote>'From a consumer's perspective, when you go see your doctor, you go see your doctor - whether it's in an office inside a larger hospital complex or right across the street,' [Zaromb's lawyer John] Phillips said. 'The doctor's practice remains the same. ... They're making the doctor's office a ‘hospital-based' clinic for one reason: to make money by charging a facility fee, not to improve consumer service.'</blockquote> Negotiating the Costs of Medical Devices One of the favorite topics on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>, at least before we found even more outrageous subjects, was the stratospheric cost of medical devices. For example, look at posts from 2005 <a href="http://hcrenewal.blogspot.com/2005/09/1600-screw-and-other-outrages.html">here</a>, <a href="http://hcrenewal.blogspot.com/2005/08/imaging-test-pre-certification-blues.html">here</a>, <a href="http://hcrenewal.blogspot.com/2005/08/wooden-headed-health-care.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2005/08/new-york-times-examines-why.html">here</a>. So last month we found out that hospital executives have come up with a revolutionary idea to combat the high cost of devices. They will actually try to see what prices the device companies charge other hospitals, and then negotiate the prices down, as <a href="http://www.reuters.com/article/2011/11/30/us-hospitals-idUSTRE7AS2ZI20111130">Reuters</a> reported as big news in late November: <blockquote>Implantable devices make up a sizable chunk of typical hospital budgets, and administrators are devising new ways to limit that cost as they brace for cuts to government reimbursement and treat more patients who can't pay for care. That means methodically working through each category of device, from heart valve replacements and stents to spinal products, to see where they can negotiate lower prices. It also means creating databases of shared information on pricing between hospitals.</blockquote> Imagine that! Of course, the notion that buyers ought to bargain with sellers to get the best price goes back a few years. However, only in 2011 did it apparently occur to hospital executives that they ought to negotiate the prices of one their most expensive purchases. This suggests that there has been something profoundly wrong with the basic assumptions underlying the commonly accepted wisdom that making the health care system more of a market will lead to more financially efficient care.  Summary In 1988, Alain Enthoven advocated in <a href="http://www.amazon.com/gp/product/0444703594/102-6581115-0444916?n=283155">Theory and Practice of Managed Competition in Health Care Finance</a>, a book published in the Netherlands, that to decrease health care costs it would be necessary to break up the "physicians' guild" and replace leadership by clinicians with leadership by managers (see 2006 post <a href="http://hcrenewal.blogspot.com/2006/03/consequences-of-breaking-physicians.html">here</a>). Thus from 1983 to 2000, the number of managers working in the US health care system grew 726%, while the number of physicians grew 39%, so the manager/physician ratio went from roughly one to six to one to one (see 2005 post <a href="http://hcrenewal.blogspot.com/2005/04/growing-proliferation-of-managers.html">here</a>). Health care went from being controlled by clinicians to controlled by a growing volume of managers.  Most of these managers were generic, in that they had little if any knowledge of, experience in, or sympathy to the values of health care. These generic managers have used the same techniques advocated for the management of supermarkets or automobile manufacturers to manage health care organizations, despite all the obvious differences in context, goals, values, and people involved. So these generic managers have brought us such "innovations" as the "hospital (marketing) representative," and the "facility fee" for outpatient visits, but only thought to negotiate device prices in 2011. But that is why we pay them <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">the big bucks</a>. How many more arguments do we need that health care organizations ought to be lead by people who understand the health care context, share its core values, and are accountable for how these organizations affect patients' and the public's health?

Hospital Executives - What Will They Think of Next?

Health care organizations are now most often run by people with management, not clinical backgrounds. It seems like business schools have t...

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EHR: "The Dangerous Decade"

A new perspective piece has appeared in the Journal of the American Medical Informatics Association. Although it is not freely available, I thought posting the abstract and the opening would be of interest: <a href="http://jamia.bmj.com/content/19/1/2.abstract"></a> <blockquote><a href="http://jamia.bmj.com/content/19/1/2.abstract">The dangerous decade</a> JAMIA Published Online First 24 November 2011 Enrico Coiera, Jos Aarts, Casimir Kulikowski Abstract Over the next 10 years, more information and communication technology (ICT) will be deployed in the health system than in its entire previous history. Systems will be larger in scope, more complex, and move from regional to national and supranational scale. Yet we are at roughly the same place the aviation industry was in the 1950s with respect to system safety. Even if ICT harm rates do not increase, increased ICT use will increase the absolute number of ICT related harms. Factors that could diminish ICT harm include adoption of common standards, technology maturity, better system development, testing, implementation and end user training. Factors that will increase harm rates include complexity and heterogeneity of systems and their interfaces, rapid implementation and poor training of users. Mitigating these harms will not be easy, as organizational inertia is likely to generate a hysteresis-like lag, where the paths to increase and decrease harm are not identical.</blockquote> The perspective piece then opens with this: <div id="p-2"></div><blockquote><div id="p-2">There is a paradox in the relationship between information and communication technology (ICT) and patient safety. ICT can improve the quality, safety and effectiveness of clinical services and patient outcomes,1 although the evidence base for this is sometimes weak.2 As a consequence, the rapid deployment of ICT on a national scale is a priority for many nations faced with a diminishing clinical workforce, increasing workloads, and resource constraints. 3 4<a class="xref-bibr" href="http://jamia.bmj.com.ezproxy2.library.drexel.edu/content/19/1/2.full#ref-4" id="xref-ref-4-1"></a></div><div id="p-3">However, ICT use can also lead to patient harm.5 Many commentators have raised concerns that ICT has yet to deliver on its promises,6 or that the rapid adoption of ICT is a risk.7 7a Errors persist in clinical practice even after ICT is introduced,8 because manual processes co-exist with the automated, and the interfaces between the two are seldom perfect. Others counter that such overemphasis on ICT-related harm only delays the implementation of a crucial technology that will save lives.9</div><div id="p-4">It appears that we are caught in a bind. The demands for health system reform are now so compelling that there appears no choice but to implement complex ICT on a large, often national, scale. Yet these ICT systems appear less mature than we would like and our understanding about how to implement and use them safely remains in its infancy. As such, we are faced with a pressing policy challenge on both the national and international stages.10</div></blockquote><div id="p-4"><a class="xref-bibr" href="http://jamia.bmj.com.ezproxy2.library.drexel.edu/content/19/1/2.full#ref-11" id="xref-ref-11-1"></a></div> They raise these rhetorical questions: <blockquote>... Where is the ‘kill switch’ in our health ICT systems when large-scale privacy breaches are occurring, or large volumes of critical patient data are being corrupted? Who is authorized to activate such a switch? </blockquote> The answers to these questions are, quite frankly: nowhere, and nobody. What we have instead is an environment of 'irrational exuberance' -- as well as 'rational exuberance', i.e., opportunism, often of a pecuniary nature. To the authors' other observations I would add that: 1) "Organizational inertia" is probably too narrow a concern. I would broaden it to "cultural inertia", especially since the <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=ecosystem">health IT "ecosystem"</a> is grossly lacking of a culture of safety and accountability; 2) The authors note that "Predicting the actual harm rate and total patient harms that we will see through the use of ICT in healthcare over the next decade is currently not possible." While I agree, and agree this inability needs to be remediated, extrapolations can be performed to achieve estimates. Regarding increased ICT use increasing the absolute number of related harms, that number could already be quite substantial as I wrote in an April 16, 2010 thought experiment at "<a href="http://hcrenewal.blogspot.com/2010/04/if-benefits-of-hit-can-be-guesstimated.html">If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers</a>." Ironically and tragically, that post was written just five days before I wrote a confidential warning letter to a hospital about EHR deficiencies I'd noted in my mother's care there, and just one month before she was severely injured at that hospital by an EHR-related error of a nature as identified in the letter. Thus, the numbers in the thought experiment should be incremented accordingly; 3) I would say regarding safety that the health IT sector is roughly in the same place as aviation was in the 1920's (e.g., unregulated, experimental technology abounding), not the 1950's, and as the maritime passenger service was in ca. 1912 (April to be precise); and 4) The authors observe that "There is however caution in the [2011 IOM] report [on health IT safety <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf" style="font-style: italic;">here</a>, PDF] that safety regulations would impede industry innovation, an argument which would literally not fly in the aviation industry ... the caution toward recommending regulation may however be misplaced. Simply put, if healthcare wants the benefits of ICT then it must actively manage its risks." I strongly agree that the IOM's cautions on regulation are misplaced, as I wrote <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">here</a>. Robust regulation could diminish ICT harm as in pharmaceuticals and medical devices (and aviation). Innovation will not be harmed, and the IT industry needs to -- and can afford to -- accept the responsibilities and obligations of being involved in healthcare. See for example "<a href="http://www.chtlj.org/sites/default/files/media/articles/v021/v021.i4.Zollers.pdf" style="font-weight: bold;">No More Soft Landings For Software: Liability for Defects in an Industry That Has Come of Age</a>" (PDF), Zollers, McMullin et al., Santa Clara Computer & High Technology Law Journal,<a href="" name="number4"> Vol. 21 No. 4, 2005.</a> -- SS

EHR: "The Dangerous Decade"

A new perspective piece has appeared in the Journal of the American Medical Informatics Association. Although it is not freely available, I...

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As U.S. Presidential Campaign Ramps Up, Newt Gingrich Plays Down Support for Health IT

Presidential candidate Newt Gingrich, who I recall hearing in person as an an invited speaker at a health IT meeting some years ago (AMIA, I believe), has been pushing health IT rather uncritically in recent years. However, he seems to have backed off that position at the election cycle heats up: <blockquote><a style="font-weight: bold;" href="http://www.ihealthbeat.org/articles/2011/12/16/as-campaign-ramps-up-gingrich-plays-down-support-for-health-it.aspx">As Campaign Ramps Up, Gingrich Plays Down Support for Health IT</a> iHealthbeat.org Friday, December 16, 2011 Now that he is a frontrunner in the race for the Republican presidential nomination, former House Speaker Newt Gingrich (R-Ga.) is downplaying his previous support for health IT adoption, The Hill's "<a href="http://thehill.com/blogs/healthwatch/politics-elections/199643-gingrich-moves-away-from-electronic-health-records" target="_blank">Healthwatch</a>" reports (Pecquet, "Healthwatch," The Hill, 12/15). History of Supporting Health ITDuring the George W. Bush administration, Gingrich worked with former CMS administrator Mark McClellan and former National Coordinator for Health IT David Brailer on federal efforts to promote health IT, according to the <a href="http://www.nytimes.com/2011/12/16/us/politics/gingrichs-health-care-policy-history-at-odds-with-gop.html?pagewanted=2" target="_blank">New York Times</a> (Rutenberg/McIntire, New York Times, 12/16). Gingrich also worked with former Senate Majority Leader Tom Daschle (D-S.D.) to co-author the forward of a book titled, "Paper Kills 2.0," which gives examples of how federal funds for health IT could be used in pilot projects to improve health care (Rowland, <a href="http://bostonglobe.com/news/politics/2011/12/16/clients-gingrich-firm-benefited-from-his-support-stimulus-funds/Egk68IClYJMtuVYWr1Iz9K/story.html" target="_blank">Boston Globe</a>, 12/16). Shortly before the passage of the 2009 federal economic stimulus package, Gingrich criticized the legislation as a "big politician, big bureaucracy, pork-laden bill." However, at the same time, Gingrich praised a provision of the stimulus package that allocated $19 billion to promote the use of health IT. He said, "I am delighted that President Obama has picked this as a key part of the stimulus package."</blockquote><div style="BORDER-BOTTOM: medium none; TEXT-ALIGN: left; BORDER-LEFT: medium none; BACKGROUND-COLOR: #ffffff; COLOR: #000000; OVERFLOW: hidden; BORDER-TOP: medium none; BORDER-RIGHT: medium none; TEXT-DECORATION: none"><div style="BORDER-BOTTOM: medium none; TEXT-ALIGN: left; BORDER-LEFT: medium none; BACKGROUND-COLOR: #ffffff; COLOR: #000000; OVERFLOW: hidden; BORDER-TOP: medium none; BORDER-RIGHT: medium none; TEXT-DECORATION: none"><div style="BORDER-BOTTOM: medium none; TEXT-ALIGN: left; BORDER-LEFT: medium none; BACKGROUND-COLOR: #ffffff; COLOR: #000000; OVERFLOW: hidden; BORDER-TOP: medium none; BORDER-RIGHT: medium none; TEXT-DECORATION: none">His views have apparently changed somewhat: <blockquote>... Campaign Plays Down Health IT Support On Wednesday, Gingrich unveiled a new brain science initiative that does not include any mention of EHRs, even though the technology was a major component of the brain science proposals he discussed over the summer.</blockquote> Politics aside (it is probably not too far from the truth to say that all politicians hold out their fingers to see what direction the wind is blowing, although Mr. Gingrich is probably becoming more aware of HIT downsides thanks to lobbying of both sides of the aisle by people such as myself and like-minded experts [1]), I cannot disagree with this: <blockquote>In August, Gingrich said he aimed to bolster brain science research in part by modernizing FDA through the use of EHRs. Gingrich said EHRs would allow for "much faster [FDA] approval times because you can monitor in real time everyone who uses the drug. And if you start getting inappropriate responses, you can change within weeks" ("Healthwatch," The Hill, 12/15).</blockquote> In fact, I was championing exactly this idea ca. 2001 when I was employed at Merck Research Labs in the Research Information Systems division. Unfortunately, the answer from more senior personnel was that doing so would be "impossible" due to inability to blind, to control the data quality, etc., responses I considered unreasonable at the time but did not argue with to avoid getting on the Short List early in my employment there. I also tried to present the idea to Merck as a former employee in Nov. 2006, at an invited presentation to the Clinical Risk Management & Safety Surveillance department of MRL entitled “<a style="font-weight: bold;" href="http://www.ischool.drexel.edu/faculty/ssilverstein/silverstein_merck_informatics_nov2006.ppt">Medical Informatics Perspectives on Leveraging the EMR in Pharma</a>" (PPT). Also see my 2007 paper "<a style="font-weight: bold;" href="http://www.ischool.drexel.edu/faculty/ssilverstein/Silverstein_Drug_Surveillance.pdf">A Medical Informatics Grand Challenge: the EMR and Post-Marketing Drug Surveillance</a>" where I address a number of issues related to using EHR's in this fashion (PDF). Using EHR's (e.g., with special screens and training) for well-defined Phase IV post-marketing surveillance studies would be one of the best uses for the technology [2]. Finally, I note that we need post-marketing surveillance of EHR's, CPOE's and other clinical IT systems themselves, not just drugs. Information technology cannot improve healthcare until it itself is improved significantly regarding its current deficiencies (see "reading list" <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">here</a> for illustrations). -- SS Notes: [1] Health IT risks are a non-partisan issue. [2] I should note that while I believe EHR's could facilitate postmarketing surveillance of drugs and devices, I take a dim view of more grandiose proposed uses of EMR's such as for comparative effectiveness research (CER). See my essay in the Journal of the American Association of Physicians and Surgeons (AAPS) entitled "The Syndrome of Inappropriate Overconfidence in Computing: An Invasion of Medicine by the Information Technology Industry?" <a href="http://www.jpands.org/vol14no2/silverstein.pdf">here</a> (PDF). </div></div> </div>

As U.S. Presidential Campaign Ramps Up, Newt Gingrich Plays Down Support for Health IT

Presidential candidate Newt Gingrich, who I recall hearing in person as an an invited speaker at a health IT meeting some years ago (AMIA, I...

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A comment posted to the website "Doctors Helping Doctors Transform Healthcare", Peter Basch, William Bria et al.

A new website has appeared that purports to be: <blockquote>A collaborative effort led primarily by doctors for doctors to provide a "trusted resource" for physicians as they work to transform health care - initially through the use of health IT.</blockquote> The site is entitled "Doctors Helping Doctors Transform Health Care" and is at <a href="http://doctorshelpingdoctorstransformhealthcare.org/">this link</a>. (I note that when one encounters such platitudinous and potentially highly ideological titles, one should ask "transform how, and into what, exactly?" I presume "transform" means, in part, to reduce risk and improve safety and outcomes - while protecting patient and physician rights.) The site has a significant number of people on their advisory board (<a href="http://doctorshelpingdoctorstransformhealthcare.org/leadership/">link</a>), but no information on compensation. I note there are industry people involved, representing a potential conflict of interest. According to one of the principals, <a href="http://doctorshelpingdoctorstransformhealthcare.org/author/pbasch/">Peter Basch, MD</a>, Medical Director, Ambulatory EHR and Health Information Technology Policy, MedStar Health, Washington, DC, <a href="http://doctorshelpingdoctorstransformhealthcare.org/2011/why-doctors-helping-doctors/">on funding:</a> <blockquote>A Few Words About Our Supporters It takes resources to create and maintain this site, to make the work of Doctors Helping Doctors possible. We have solicited unrestricted contributions from individuals and organizations who believe in our mission and are able to support its work. In particular, we wish to thank Patrick Soon-Shiong of the Chan Soon-Shiong Family Foundation, John Glaser of Siemens Health Services; and Andy Slavitt of Optum’s Institute for Sustainable Health.</blockquote> To my knowledge, I've never met Dr. Basch, but at meetings I have met one of the other principals of the new website, <a href="http://doctorshelpingdoctorstransformhealthcare.org/author/wbria/">William Bria, III, MD</a>, Chief Medical Information Officer, Shriners Hospitals for Children; President and Co-Founder, Association of Medical Directors of Information Systems (AMDIS), St. Petersburg, FL. Dr. Basch's writing has appeared at Healthcare Renewal before, such as at the Jan. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/01/throwing-national-research-council.html">Throwing The National Research Council Report On Health IT Under The Bus, Part 1: MedStar Health</a>." In the new site, Dr. Basch states that: <blockquote>As early adopters, EHR implementers, and practicing physicians, we have seen the “bad and the ugly” as well as the promise of health IT. We understand how health IT can and should be used to make care better, safer, and more value-laden. As such, we believe that unnecessarily harsh criticism of Meaningful Use—which we have heard from some quarters—and uncritical cheerleading—which we have also heard—are equally unhelpful. We see physician “extremism” essentially marginalizing what is needed now more than ever—a clear and constructive physician voice, articulating not for compliance with Meaningful Use, but rather leveraging the opportunity that Meaningful Use presents, and consistently inserting the highest ideals that led us all to choose a career in medicine.</blockquote> While on the surface this is not an unreasonable position, I fear the word "extremism" is used as a metaphor for those who express genuinely critical appraisals of the state of health IT as it now exists, on issues regarding safety, efficacy, usability, need for regulation, vendor, buyer and user liability, and other "unpleasant" topics. I do note precious little on the site about educating physicians on the considerable downsides of health IT as it currently exists, nor on the scientific literature expressing doubts about its safety, efficacy, usability, ROI and other issues (such as <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">here</a>). There is, it would seem obvious, no ethical excuse for introducing medical devices and other technology of unknown benefit and of unknown risk magnitude (as recently reported by the IOM, see <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">this post</a>), that is <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">unregulated</a>, into life-critical domains such as medicine without explicit acknowledgement of experimentation. Human subjects experimentation requires, of course, explicit informed consent under the <a href="http://grants.nih.gov/grants/policy/hs/ethical_guidelines.htm">many guidelines</a> formulated as a result of past systemic abuses. Also, users need to be fully aware of the risks. Such informed consent cannot be accomplished, and awareness attained by physicians regarding the dangers of use of health IT in its present form, through simple "best practices" protagonism. For instance, health IT can be inherently defective and/or <a href="http://www.tinyurl.com/hostileuserexper">mission hostile</a> (worse, the industry is unregulated), and can injure or kill. Several illustrative examples just off the top of my head are at: <ul><li>"<a href="http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html">FDA Recalls Draeger Health IT Device Because This Product May Cause Serious Adverse Health Consequences, Including Death</a>";</li></ul><ul><li>"<a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">Lifespan (Rhode Island): Yet another health IT 'glitch' affecting thousands</a>";</li></ul><ul><li>"<a href="http://hcrenewal.blogspot.com/2010/07/maude-database-patient-outcome-death.html">FDA MAUDE Database: Patient Outcome - Death</a>" and "<a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">FDA Manufacturer and User Facility Device Experience (MAUDE) database - case reports of EHR defects</a>";</li></ul><ul><li>"<a href="http://hcrenewal.blogspot.com/2010/12/ecri-healthcare-it-in-top-ten-health.html">ECRI: Healthcare IT In Top Ten Health Technology Threats to Patient Safety</a>";</li></ul><ul><li>"<a href="http://iig.umit.at/efmi/badinformatics.htm">Bad Health Informatics Can Kill</a>" [European Federation for Medical Informatics]; </li></ul><ul><li> "<a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">A Study of an Enterprise Health information System</a>" [Australia - severe deficiencies in software engineering noted in major U.S. vendor ED EHR system that cause user confusion as well as data corruption/loss];</li></ul><ul><li>"<a href="http://www.isb.nhs.uk/documents/isb-0160/dscn-18-2009/0160182009specification.pdf">Health informatics — Guidance on the management of clinical risk relating to the deployment and use of health software</a>" [ISO/UK NHS - with an accounting of EHR-related medical errors in Annex A]; </li></ul><ul><li> and a personal account "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=diary">A Diary of EHR-Initiated Tragedy</a>."</li></ul> Not even including privacy and confidentiality issues (see <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">this query link</a> on those issues), should physicians, nurses, patients and other stakeholders not be explicitly educated on the issues of risk, that can be greatly replicated/amplified across hundreds or thousands of patients by EHRs as opposed to paper, and on actual injuries and deaths that have occured? If not, why not? Are not these issues and the issue of the <a href="http://hcrenewal.blogspot.com/2010/08/health-it-via-observation-and-research.html">lack of a culture of safety in the health IT field</a> at least as important, if not more important for clinicians, patients, healthcare executives and other stakeholders to be strongly aware of than "best practices" and "meaningful use?" (I note that the "negative reports are mere anecdotes" argument commonly used by health IT pundits only shows, as in the Aug. 2011 essay by a senior clinician in Australia "<a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things</a>", that those making that argument need to attend revision courses in research methodology and risk management.) In consideration of the "Doctors Helping Doctors" site's seemingly uncritical pro-HIT advocacy, I have posted the following note at the end of Dr. Basch's introductory essay. The comment appears <a href="http://doctorshelpingdoctorstransformhealthcare.org/2011/why-doctors-helping-doctors/#comment-20">at this link</a> and is awaiting moderation. The comment's remaining online would be a sign that the site is not another attempt to "<a href="http://hcrenewal.blogspot.com/2011/03/how-lousy-health-it-gets-pushed-on.html">control the channel</a>", and is truly serious about being "trusted." It would be a sign of a site truly concerned with "physicians helping physicians transform health care" while not sacrificing patients as unconsenting test subjects of unregulated, experimental <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">software-based medical devices</a> in the process. <cite class="fn"><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" rel="external nofollow" class="url"></a></cite><blockquote><cite class="fn"><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" rel="external nofollow" class="url">S Silverstein MD</a></cite> says: <div class="comment-meta commentmetadata"> <a href="http://doctorshelpingdoctorstransformhealthcare.org/2011/why-doctors-helping-doctors/#comment-20">December 17, 2011 at 10:29 pm</a> </div> Doctors, One way to help doctors transform healthcare would be to educate them on the downsides of information technology in healthcare, how to avoid them, and the conflicting literature on benefits (e.g., as at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglis">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist</a>). I do not see such information here yet. I do expect some such information will follow. Sincerely, Scot Silverstein --------------------------------------------------- Scot M. Silverstein, MD Consultant/Independent Expert Witness in Healthcare Informatics (May 2010-present) Adjunct faculty in Healthcare Informatics and IT (Sept. 2007-present) Assistant Professor of Healthcare Informatics and IT, and Director, Institute for Healthcare Informatics (2005-7) Drexel University College of Information Science and Technology 3141 Chestnut St., Philadelphia, PA 19104-2875 Email: sms88 AT drexel DOT e-d-u Bio: <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm">http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm</a> Common Examples of Healthcare IT Difficulties: <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/ </a> Note: I am cross-posting this comment on Healthcare Renewal blog under the title "A comment posted to the website 'Doctors Helping Doctors Transform Healthcare, Peter Basch, William Bria et al.'"</blockquote> It is my hope the comment stays, and receives a reasoned reply. -- SS Dec. 23, 2011 addendum: My comment appears to have disappeared. I leave it to the reader to determine what that means about the site "Doctors Helping Doctors Transform Healthcare." -- SS

A comment posted to the website "Doctors Helping Doctors Transform Healthcare", Peter Basch, William Bria et al.

A new website has appeared that purports to be: A collaborative effort led primarily by doctors for doctors to provide a "trusted resou...

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Medtronic Settles, Yet Again

And the march of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> continues... Circling around the block and coming in front of the viewing stand again is device manufacturer Medtronic.  The Latest Medtronic Settlement As Bloomberg <a href="http://www.bloomberg.com/news/2011-12-13/medtronic-to-pay-23-5-million-to-settle-allegations-of-doctor-kickbacks.html">reported</a>: <blockquote>Medtronic (MDT) Inc., the world’s biggest maker of heart rhythm devices, agreed to pay $23.5 million to settle claims it paid kickbacks to doctors who implanted its pacemakers and defibrillators in patients, the U.S. Justice Department said in a statement. Medtronic agreed yesterday to settle two lawsuits filed in federal courts in California and Minnesota accusing the company of violating the federal False Claims Act by paying physicians $1,000 to $2,000 for each patient who was implanted with one of the company’s devices, according to the Justice Department. 'Patients who rely on their health-care providers to implant vital medical devices expect that those decisions will be made with the patients’ best interests in mind,' Tony West, assistant attorney general for the Justice Department’s Civil Division, said in an e-mailed statement. 'Kickbacks, like those alleged here, distort sound medical judgments with financial incentives paid for by the taxpayers.' </blockquote> As usual, Medtronic did not admit doing anything wrong: <blockquote>Medtronic said in an e-mailed statement that it makes no admissions that the studies were 'improper or unlawful.' The company also said it established a reserve for the anticipated payment in the fourth quarter of fiscal year 2011. 'We are happy that the investigation is behind us, so we can continue designing and executing clinical trials that generate evidence to improve patient care, outcomes and cost effectiveness,' Marshall Stanton, vice president of clinical research and reimbursement for the cardiac and vascular group....</blockquote>Previous Legal Settlements by Medtronic Note that this is not the first time Medtronic has been accused of paying doctors (kickbacks, this time, which seem to be the ethical equivalent of bribes) to use its products. The Bloomberg report also noted: <blockquote>In 2006, Medtronic agreed to pay $40 million to settle allegations that its Sofamor Danek unit violated state laws and the False Claims Act by paying sham consulting fees and providing lavish trips to doctors who used its products from 1998 to 2003. </blockquote>Perusing the <a href="http://hcrenewal.blogspot.com/search/label/Medtronic">Medtronic file on Health Care Renewal</a> also showed that Medtronic has had to settle other lawsuits alleging misconduct: - In 2008, Medtronic subsidiary Kyphon settled a suit for $75 million and signed a corporate integrity agreement for allegations that it defrauded Medicare through a scheme that lead to excessive hospitalization for patients who received the company's spine surgery device (link <a href="http://hcrenewal.blogspot.com/2008/05/corporate-integrity-agreement-for.html">here</a>) - In 2010, Medtronic settled multiple civil lawsuits for $268 million for allegations that it marketed an implantable cardiac defibrillator with faulty leads whose failures lead to 13 deaths (link <a href="http://hcrenewal.blogspot.com/2010/10/last-weeks-scandals.html">here</a>) Cases of Apparent Conflicts of Interest Generated by Medtronics' Payments In fact, paging through the <a href="http://hcrenewal.blogspot.com/search/label/Medtronic">Medtronic file on Health Care Renewal</a>, we also found these cases of apparent conflicts of interest that Medtronic caused by making payments to or otherwise creating financial relationships with: - FDA advisory board members (2007 link <a href="http://hcrenewal.blogspot.com/2007/07/blogscan-more-conflicted-members-on-fda.html">here</a>), - health care professionals who appeared on public television programs about heart disease and treatments of it (2007 link <a href="http://hcrenewal.blogspot.com/2007/10/funding-of-mysterious-human-heart-and.html">here</a>), - members of a non-profit organization which was supposed to guide the FDA regarding drug development  (2007 link <a href="http://hcrenewal.blogspot.com/2007/11/questions-about-board-of-new-reagan.html">here</a>), - prominent academic orthopedic surgeons who were in positions to influence other physicians' choices of orthopedic devices (2008 link <a href="http://hcrenewal.blogspot.com/2008/09/more-lucrative-payments-to-orthopedic.html">here</a> and 2009 links <a href="http://hcrenewal.blogspot.com/2009/01/on-wisconsins-talking-heads.html">here</a>, <a href="http://hcrenewal.blogspot.com/2009/07/polly-want-million-plus.html">here</a> and <a href="http://hcrenewal.blogspot.com/2009/12/20-million-dollar-journal-editor.html">here</a>), - a military surgeon who wrote questionable articles about the supposed virtues of a Medtronic bone growth product (2009 link <a href="http://hcrenewal.blogspot.com/2009/05/breach-of-trust.html">here</a>), - a top leader of US Veterans Affairs Department who objected to the appointment of an industry critic as US Surgeon General (2010 link <a href="http://hcrenewal.blogspot.com/2010/10/toxic-and-dangerous-watchdog-vs.html">here</a>), - spine surgeons apparently who could promote Medtronics' spine surgery products in (2010 link <a href="http://hcrenewal.blogspot.com/2010/12/blogscan-medtronics-multi-million.html">here</a>) and who did not disclose all such payments when writing ostensibly scholarly articles on the subject (2010 link <a href="http://hcrenewal.blogspot.com/2010/12/spine-surgeons-reticent-about.html">here</a>) So prior to the current settlement for "alleged" kickbacks, Medtronic had a long history of allegations that it had financial relationships with physicians who were in a position to promote the use of its products or its policy interests. Why the Bad Behavior Continues The latest settlement by Medtronic illustrates why the anemic approach by US government agencies to health care corporate misbehavior does not deter bad behavior. - The punishment was a fine not large enough to have any effect on the finances of the corporation.. Such a relatively small financial penalty might just be seen as a cost of doing business by company executives.  (See <a href="http://brodyhooked.blogspot.com/2011/12/here-we-go-again-with-form.html">these comments</a> on the current case by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.) -  The punishment was not a result of any specific bad behavior.  In this case, like many others, the corporation did not have to admit to anything.  This leads to the paradox of a punishment meted out for apparently nothing other than "alleged" actions, making it appear that the actual punishment was just a payment by the company to allow it to continue the sorts of actions that were alleged with impunity.  (Such punishments without clear crimes happen all the time in cases affecting the finance sector.  See a federal judge's condemnation of this practice <a href="http://hcrenewal.blogspot.com/2011/11/will-citigroup-ruling-challenge-health.html">here</a>.)  -  The punishment seems unrelated to the corporation's historic behavior.  In this case, there was no reference to the company's previous settlements, or the other allegations of questionable payments to physicians and health care decision makers in other circumstances listed above.  (Keep in mind that <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> strives to present interesting cases, but does not have the resources to report on every single case of bad behavior by health care organizations.  Hence the list above of apparent bad behavior may not be complete.) -  The punishment applied to the corporation as a whole, and hence may disadvantage many people, stockholders and corporate employees in particular, who had nothing to do with the alleged bad behavior.  On the other hand, those who authorized, directed, or implemented the bad behavior were not subject to any negative consequences.  So why on earth would corporate leaders cease bad behavior which could increase revenues short-term and hence increase their compensation (e.g., in 2011, the Medtronic CEO received $9,624,709 according to the <a href="https://www.proxydocs.com/0/000/427/737/proxy_statement.pdf">2011 proxy statement</a>), when the likelihood of any negative consequences for them appears to be near zero?  This would be bad enough if the bad behavior only causes financial disadvantage for stockholders or corporate employees. However, the bad behavior in question seems to repeatedly involve paying physicians and other health care decision makers in ways likely to influence their decisions in favor of Medtronics' products and corporate well-being.  Making decisions this way, however, is unlikely to be good for patients' and the public's health, as it is likely to lead to excess use of expensive tests and treatments that may have adverse effects, sometimes severe.  Thus patients may suffer unnecessary morbidity and mortality, and the public at large may pay far too much for medical care. So will we see in our lifetimes honest, tough policing of health care corporate behavior?  Will the punishments start to fit the crime, and will they be significant enough to deter future misbehavior?  Why do we continue to accept government actions that seem more solicitous of the executives of big corporations than the public for whose benefit government is supposed to be run?  Where is the outrage?    So, once more, with feeling.... in my humble opinion, until the people responsible for the bad behavior experience negative consequences from that behavior, they will continue to perform, direct, and condone bad behavior. We will not achieve real health care reform in the US until we effectively deter unethical, self-serving behavior by leaders of health care organizations. ADDENDUM (15 December, 2011) - <a href="http://gooznews.com/?p=3437">On the GoozNews blog</a>, Merrill Goozner called Medtronic's actions "a crime against science."

Medtronic Settles, Yet Again

And the march of legal settlements continues... Circling around the block and coming in front of the viewing stand again is device manufact...

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FDA Recalls Draeger Health IT Device Because "This Product May Cause Serious Adverse Health Consequences, Including Death"

More health IT madness, in the form of an actual FDA recall: <a href="https://exchangeweb.drexel.edu/owa/redir.aspx?C=6d6383ecf8a447d49bdd4de3b034a759&URL=http%3a%2f%2fwww.fda.gov%2fMedicalDevices%2fSafety%2fRecallsCorrectionsRemovals%2fListofRecalls%2fucm282461.htm"></a> <blockquote><a href="http://www.fda.gov/MedicalDevices/Safety/ucm282461.htm" target="_blank">FDA Recall notice</a> Draeger Medical Inc., Infinity Acute Care System Monitoring Solution (M540) Recall Class: Class I [the most serious type of recall, see below - ed.] Date Recall Initiated: October 18, 2011 Product: Infinity Acute Care System Monitoring Solution (M540), Catalog number MS25510 All serial numbers are affected by this recall. This product was manufactured from March 1, 2011 through September 30, 2011 and distributed only to the Rush University Medical Center (Chicago, Illinois) from July 1, 2011 through September 30, 2011. Use: This product is a networked solution system used to monitor a patient’s vital signs and therapy, control alarms, review Web-based diagnostic images, and access patient records. The number of monitored vital signs can be increased or decreased based on the patient’s needs. Recalling Firm: Draeger Medical, Inc. 3135 Quarry Rd., Telford, Pennsylvania 18969-1042 Manufacturer: Draeger Medical GmbH, Moislinger Allee 53-55_23558, Lubeck, Germany Reason for Recall: The weight-based drug dosage calculation may indicate incorrect recommended values, including a drug dosage up to ten times the indicated dosage. Additionally, there may be a 5-10 second delay between the electrocardiogram and blood pressure curves (waveforms) at the Infinity Central Station. This product may cause serious adverse health consequences, including death. Public Contact: Draeger Medical, Inc. 3135 Quarry Road Telford, Pennsylvania 18969-1042_215-660-2349 FDA District: Philadelphia FDA Comments: On October 17, 2011, the company sent the Rush University Medical Center a letter stating that users should enter the patient’s weight by way of the admin/demographics screen to ensure the drug dosage is calculated as intended. Additionally, the company’s letter states that users should follow the instructions for Use of the Infinity Acute Care System Monitoring Solution. The Instructions for Use includes, "For primary monitoring and diagnosis of bedside patients, use the bedside monitor. Use the Infinity Central Station only for remote assessment of a patient's status." [That is, clinicians should work around the device's defects, which would seem to hold the computer's rights over the patients' rights -- rather than taking the device out of service immediately and having the vendor fix it - ed.] Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.</blockquote> I find a software company advising clinicians to make sure to "work around" blatant IT defects in "acute care environments" the height of arrogance and contempt for patient safety. Yes, acute care environments are not unpredictable, chaotic environments often moving a mile a minute. They are precisely the environment where everyone can sit around on their butts and leisurely hold, over pizzas and cokes, a committee meeting where each and every move can be discussed, just like in a software development shop ... I also find the statement that this medical device was "distributed only to the Rush University Medical Center" remarkable. If true, it raises a number of issues that make me very uncomfortable: <ul><li>How did the company's letter to Rush make its way to FDA? Whistle blower?</li></ul><ul><li>What testing was done by the manufacturer of this medical device before release to a live-patient environment?</li></ul><ul><li>Who approved this software "going live?" What due diligence was performed?</li></ul><ul><li>Was this a software beta test of experimental software on live subjects?</li></ul><ul><li>Did Rush University Medical Center have some sort of quid pro quo (e.g., financial arrangement) with the software company?</li></ul><ul><li>Did Rush seek IRB approval of this device?</li></ul><ul><li>Were patients presented with an informed consent process regarding its use in their care?</li></ul><ul><li>Were any patients actually injured or did any die as a result of this software?</li></ul> The answers to these questions need to be sought by FDA. -- SS

FDA Recalls Draeger Health IT Device Because "This Product May Cause Serious Adverse Health Consequences, Including Death"

More health IT madness, in the form of an actual FDA recall: FDA Recall notice Draeger Medical Inc., Infinity Acute Care System Monitoring S...

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The EHR Mission Hostile User Experience, Part 10: Cerner Powerchart - via FDA's MAUDE Database

<center style="font-weight: bold;">"You should not have to work around something that is not in the way" - SS</center> Some time ago, I'd written an eight part (later expanded to nine part) series on health IT mission hostile user interfaces and experiences. (Note: Part 1 of this series is <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-idiots-part-1.html">here</a>, part 2 is <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and.html">here</a>, part 3 is <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and_24.html">here</a>, part 4 is <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and_26.html">here</a>, part 5 is <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and_27.html">here</a>, part 6 is <a href="http://hcrenewal.blogspot.com/2009/02/it-makes-healthcare-easier-is-this.html">here</a>, part 7 is <a href="http://hcrenewal.blogspot.com/2009/03/information-technology-makes-healthcare.html">here</a>, and part 8 is <a href="http://hcrenewal.blogspot.com/2009/03/malpractices-of-multitudes-mission.html">here</a>. 2011 addendums: a post that can be considered part 9 is <a href="http://hcrenewal.blogspot.com/2011/04/special-k-red-berries-mission-hostile.html">here</a>, part 10 is <a href="http://hcrenewal.blogspot.com/2011/12/ehr-mission-hostile-user-experience.html">here</a>.) Here is an addendum, part 10, from the FDA <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm" style="font-family: arial;">Maude</a> (Manufacturer and User Facility Device Experience) Database. I do not know who wrote it or where it was from. It was received by FDA as indicated on 3 April 2011: <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2045867" style="font-family: arial;"></a> <blockquote style="font-family: arial;">FDA MAUDE REPORT <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2045867">CERNER POWERCHART </a> Event Type Other Event Description I am writing to report a problem in the design of the cerner powerchart computer provider order entry (cpoe) product. As i will describe below, these design flaws are largely responsible for approximately 100 medication errors per day in our 240 bed hosp. The (b)(6) hosp in (b)(6) is a 240 bed teaching hosp. We are owned by the (b)(6). We have to be one of the only hospitals in the country to fully implement cpoe with two entirely different electronic medical records (emr). In 2007, we completed a comprehensive cpoe implementation using idx 3. 1 (which was later purchased by general electric). Our self-reported medication error rate was <2 error reports per day. In (b)(6) of 2010, we transitioned our emr to cerner millennium - powerchart (b)(4). This implementation was done as a first step to converge onto a single electronic medical record across the (b)(6) enterprise. Despite extensive nursing informatics support (approx. 7000 hrs per month for the first six months after implementation), our error rate went from approx. 176 medication errors per day one month after implementation to approx. 100 medication errors per day currently. It has been stable at this level for at least the past 3 months. Many of these errors involve high risk medications (e. G. Heparin, morphine). In order to understand the etiology of the errors, i need to explain how cerner processes cpoe orders. With cerner, orders are grouped into plans ("powerplans"). These plans can include sub-plans ("phases") and sub-sub-plans ("sub phases"). A typical orders display screen appears as follows: (b)(4). Under the plans is an order tab which displays other orders. This design allows two distinct sources of error. First, there is no consistent way to view orders for medications. A medication order can display either in a plan, sub-plan, or under the orders tab. In order to find a given medication, cerner mandates that you click through each and every plan. This facilitates duplication of both medication and non-medication orders (there is a medication checker which is so poorly designed and does little to aid the pharmacists in detecting duplicate medications). Second and more dangerous, high risk intravenous medications can be run either inside or outside of the plan. Cerner programming [i.e., the user interface design -ed.] does not keep high risk medications in a consistent spot. It is very easy to stop monitoring for heparin (which is included in the heparin plan) while continuing the heparin (which is outside the plan) or vice-versa. As you can probably guess, we formed multiple interdisciplinary teams to address these deficiencies. [Workarounds - ed.] I was the lead physician on the orders team. Although we were unable to reduce the error rate, it is not close to an acceptable level. Again, i believe this is because of the design of the cerner product which is why i chose to bring this to your attention. With issues this complex, i am a firm believer that "seeing is believing. " if desired, i would be happy to arrange a web conference to demonstrate my concerns. Brand Name CERNER POWERCHART COMPUTER Type of Device NONE Manufacturer (Section F) CERNER Manufacturer (Section D) CERNER Device Event Key 2081342 MDR Report Key 2045867 Event Key 1942844 Report NumberMW5020161 Device Sequence Number 1 Product Code LNX Report Source Voluntary Reporter Occupation Other Type of Report Initial 1 Device Was Involved in the Event 1 Patient Was Involved in the Event Date FDA Received 04/03/2011 Is This An Adverse Event Report? No Is This A Product Problem Report? No Device Operator Service Personnel Was The Report Sent To Manufacturer? No Is the Device an Implant? No Is this an Explanted Device? Page Last Updated: 11/30/2011 </blockquote>I will let the FDA report speak for itself, with only one question: When will the designers, developers, purchasers and implementers of medical devices like this start to be held criminally liable for patient injuries that occur from the risk these devices pose to patient safety? <blockquote style="font-family: arial;"> <a href="http://www.thefreedictionary.com/criminal+negligence">criminal negligence</a> - (law) recklessly acting without reasonable caution and putting another person at risk of injury or death (or failing to do something with the same consequences)</blockquote> It's not as if the issues related to good user interface design are a mystery, nor have those issues been a mystery for at least a few decades. An EHR design as described, if accurate, while perhaps "nifty" in some way from the computer-techie perspective, would require significant recklessness to design and to actually implement in a life-critical setting. Those who try to point out these issues internally are sometimes subject to retaliation (for not being a "team player", of course, which in today's parlance means someone who is silent, or silenced, or a co-conspirator regarding managerial mediocrity, malfeasance, or madness). An example is <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=lawsuit">here</a>. We at Healthcare Renewal simply refuse membership on that team. (Did I mention this deterministic miracle-making technology is slated via the HITECH Act for rollout in the U.S., unless the medical professional or organization is willing to accept progressive cuts to their Medicare reimbursement?) -- SS

The EHR Mission Hostile User Experience, Part 10: Cerner Powerchart - via FDA's MAUDE Database

"You should not have to work around something that is not in the way" - SS Some time ago, I'd written an eight part (later exp...

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