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Health IT Amateurs, Logical Fallacy and Hospital Leadership: An Inhibitor to Good Health IT

An excellent three-part article on local providers' efforts to "join the electronic medical record/clinical IT movement", including a middle section "<a href="http://www.thonline.com/news/tri-state/article_0db56834-fc4d-5d9d-9ca0-71c7af76117b.html?mode=story" target="_blank">One doctor has reservations about EMR's design, usability</a>", was published yesterday in the <a class="l" href="http://www.thonline.com/">Dubuque (IA) Telegraph Herald</a>. I was cited as that doctor (subscription required). The article began: <blockquote class="tr_bq">Dr. Scot Silverstein travels the country attending conferences [and <a href="http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html" target="_blank">other countries</a> as well - ed.], speaking on panels and voicing concerns about health care's headlong rush into a reliance on electronic medical record systems. </blockquote> "Headlong rush" is an accurate description of my beliefs, as in my "cart before the horse" posts <a href="http://hcrenewal.blogspot.com/2012/06/cart-before-horse-part-3-ahrqs-health.html" target="_blank">here</a>. The newspaper reporter continues: <blockquote class="tr_bq">"Older and younger physicians alike are increasingly concerned about the poor design and poor usability of clinical IT," Silverstein said.  </blockquote> Not only that, but so is ONC, the Institute of Medicine and the National Institute for Standards and Technology, among others, who I indicated were the source of my quotes. <blockquote class="tr_bq">The Drexel University College of Information Science and Technology faculty member calls "EMR" an anachronistic term from a time when the systems were merely storage tools for records.  "What is meant in 2012 is not just an innocuous 'filing cabinet,' but an enterprise clinical resource management and workflow control system - not just storing records, but regulating and governing all clinical behavior and action," Silverstein said.</blockquote> That is, indeed, my own observation. <blockquote class="tr_bq">Silverstein contends such systems are inappropriate for some health-care environments, such as emergency rooms and intensive-care units.  "They slow down and distract clinicians due to their generally poor user interfaces, in the worst possible setting, and disrupt clinician cognition," he said.</blockquote> Again, not only me.  As I had written to the reporter: <blockquote class="tr_bq">... These devices are not appropriate for high-risk, high-intensity environments such as ED's, ICU's etc.  They slow down and distract clinicians due to their generally poor user interfaces, in the worst possible setting, and disrupt clinician cognition.  But don't take my word for it.  See the 2012 report from the Institute of Medicine on healthcare IT safety (I wrote about it at <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html</a>), the National Institute of Standards and Technology report on clinical IT usability (<a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html">http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html</a>) and the literature I collated at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist</a>. </blockquote> In fact, document image management systems and human data abstractors are a good tradeoff to meet the needs of the most time-pressed clinicians whose time is a hospital's most valuable asset, and to make patient charts available when and where needed.  This is as opposed to "digital data field and form-based" (i.e., conventional) EMR's that force the clinicians to waste their time in clerical functions and distract them from pressing clinical matters and informational accuracy.  He then reports: <blockquote class="tr_bq">Silverstein defines such cognition as the decision making and problem solving necessary to provide quality health care.</blockquote> Precisely. <blockquote class="tr_bq">... Silverstein thinks current clinical IT programs focus too much on raw data and not enough on supporting a physician's decision-making abilities. "As a result, valuable time and energy is spent managing data as opposed to understanding the patient," he said. "Ideally, IT systems would place raw data into context with current medical knowledge to provide clinicians with computer models that depict the health status of the patient, including information on how different organ systems are interacting, epidemiological insight into the local prevalence of disease and potential patient-specific treatment regimens." </blockquote>  Actually, it's not just that I think and said these things.  The quote came verbatim, as I had indicated, from the prestigious <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572" target="_blank">National Research Council of the United States and their 2009 study on health IT,</a> led by healthcare IT pioneers Drs. Octo Barnett and William Stead. Any time logically consistent, ethics-based, common sense observations and opinions are expressed about health IT, however, one can always rely on a pundit or hospital executive for a misdirecting, illogical, and/or impertinent comment. The expected came from Kay Takes, vice president of patient care services at Mercy Medical Center-Dubuque: <blockquote class="tr_bq"> ... Kay Takes, vice president of patient care services at Mercy Medical Center-Dubuque, said the hospital finds electronic medical records a help in the critical environment of the ICU. "Specifically in the ICU, in the last 13 months we've gotten enhancements that allow us to download values from the medical equipment - it's automatically pulled into the medical record," she said "It's been fantastic. The availability of the information is enormously valuable. It's been a lot more of a benefit than a hindrance."</blockquote> I speak from experience, in having been involved in developing those exact same capabilities in the mid 1990's (or, most accurately, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU" target="_blank">protecting patients from the dangers created by the IT department in the project</a>), that they are a convenience to those who formerly had to collect the data manually and write it on the ICU flowsheet. The capabilities are also a mild convenience to clinicians who view the data, although the surface area of a paper flowsheet is a great advantage in seeing more data in one's field of view at one time than the usual small computer screen (to illustrate see my Feb. 2012 post EHR Workstation Designed by Amateurs <a href="http://hcrenewal.blogspot.com/2012/02/ehr-workstation-designed-by-amateurs.html" target="_blank">at this link</a> and my Jan. 2012 post An 'Anecdotal Complaint' About An ICU EHR <a href="http://hcrenewal.blogspot.com/2012/01/anecdotal-complaint-about-icu-ehr.html" target="_blank">at this link</a>). From the latter post: <blockquote class="tr_bq">... And we do still talk to each other – but even that doesn’t always “work out”, because we’ve lost our operational minds (collectively) – the shared-by-all compact, visually all data in one place, and temporally arranged – i.e., the shared nurse/doc/resp flowsheet [traditionally in an ICU, a long tabular scroll of paper for "at a glance" patient status overview - ed.] – where everybody was looking at the same page, which we no longer are – as the team is slowly discovering. And which required no logon for sign-over bedside rounding (~40 minutes for 20-30 babies was the allotted time). The flowsheet needed only a 10-15 second glance to spot developing problems; “the computer” is effectively inaccessible in the time allotted for the twice daily sign-n-out “rounds”. </blockquote> Ultimately, though, Ms. Takes, if quoted accurately, commits the logical fallacy of <a href="http://en.wikipedia.org/wiki/Ignoratio_elenchi" title="Ignoratio elenchi">ignoratio elenchi</a> ("ignorance of refutation", missing the point) – an argument that may in itself be valid, but does not address the issue in question. For this convenience does not at all justify the downsides of EHRs, especially in an ICU:  increased time for task completion, increased risk of errors of commission or omission, and the other risks as outlined in sources such as <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">FDA's 2010 Internal Memo on H-IT Risks</a>, and recently by AHRQ in their <a href="http://healthit.ahrq.gov/HealthITHazardManagerFinalReport" target="_blank">IT Hazards Manager project</a> (Appendix B). Let's review those risks and failure modes from the AHRQ report, all observed empirically in the real world.  From the report: <blockquote class="tr_bq">A health IT hazard is a characteristic of any health IT application or its interactions with any other health care system (e.g., the people, equipment and work spaces of an ICU) that increases the risk that care processes will be compromised and patients harmed.</blockquote> The potential outcomes of these hazards include medical privacy breach/identity theft, medical misadventures such as errors of commission or omission resulting in "close calls" (errors barely averted), or patient injury, or death, stress on clinicians reducing their performance, and documentation errors or data corruption increasing the risk of errors in the short, medium or long term.  In short, nothing you'd likely desire to occur while you or a family member was a patient: <blockquote class="tr_bq">Usability • Information hard to find • Difficult data entry • Excessive demands on human memory • Sub-optimal support of teamwork (situation awareness) • Confusing information display • Inadequate feedback to the user • Mismatch between real workflows and HIT • Mismatch between user mental models/expectations and HIT Data Quality • IT contributed to entry of data in the wrong patient’s record • Organizational policy contributed to entry of data in the wrong patient’s record • Patient information/results routed to the wrong recipient • Discrepancy between database and displayed, printed or exported data • Faulty reference information • Unpredictable elements of the patient’s record available only on paper/scanned documents • Lost data • Inaccurate natural language processing • Virus or other malware Decision Support • Excessive non-specific recommendations/alerts • Faulty recommendation • Missing recommendation or safeguard • Inadequate clinical content • Inappropriate level of automation Vendor Factors • Sub-optimal interfaces between applications and devices • Faulty vendor configuration recommendation • Unusable software implementation tools • Non-configurable software • Inadequate vendor Testing • Inadequate vendor software change control • Inadequate control of user access • Faulty software design (specification) Local Implementation • Faulty local configuration or programming • Inadequate local testing • Inadequate project management • Inadequate software change control • Inadequate control of user access • Suboptimal interface management Other factors • Inadequate training • Excessive workload (including cognitive) • Inadequate organizational change management • Inadequate management of system downtime or slowdown • Unclear policies • Compromised communication among clinicians (i.e., during handoffs) • Interactions with other (non-HIT) care systems • Physical environment (e.g., hardware location, lighting, engineering) • Inadequately secured data • Hardware Failure • Use error in the absence of other factors</blockquote> The convenience of automated data collection through an EMR system comes at, one might say, a slight cost that may not be realized by health IT amateurs.**  Unfortunately, their lack of knowledge of these issues reduces the caution and "pushback" required for good health IT to become the norm, and permits bad HIT to be sold. -- SS ** Amateurs in the sense that I am a <a href="http://www.arrl.org/" target="_blank">radio amateur</a>, not a professional, formally trained telecommunications engineer, and would never take a major role in an enterprise telecommunications project, especially a mission-critical one. 8/27/12  Addendum: A typical, anonymous, irrational response of the type we've seen on this blog before (as for example <a href="http://hcrenewal.blogspot.com/2012/04/allscripts-shares-plunge-on-weak.html?showComment=1335626142332#c3490189922394571931" target="_blank">here</a> and <a href="http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html" target="_blank">here</a>) has been posted as a comment to the newspaper story: <blockquote class="tr_bq"> "nemesis" posted at 1:19 pm on Mon, Aug 27, 2012.  He travels the country complaining about existing systems? Perhaps the good prof could spend a little time designing the ideal interface/system and see if he can get anyone interested. Surely his design would win them all over.</blockquote> The problem with this type of comment, of course, is that it's logically fallacious (a form of ad hominem and an odd "appeal to perfection") and irrelevant.  It is no way responds to or refutes the issues I raise in the article.    It likely comes from a health IT pundit of some sort, but hopefully not someone in a position of authority.  In medicine, the rule of thumb is simple:  "Critical thinking always, or your patient's dead." -- SS

Health IT Amateurs, Logical Fallacy and Hospital Leadership: An Inhibitor to Good Health IT

An excellent three-part article on local providers' efforts to "join the electronic medical record/clinical IT movement", inc...

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Will Another Study on Physician Burnout Finally Lead to Addressing its Causes?

The latest article on physician burnout has actually attracted some media attention.  e.g., <a href="http://www.usatoday.com/money/industries/health/story/2012-08-20/physician-burnout/57173110/1">here</a> and <a href="http://www.bloomberg.com/news/2012-08-20/about-half-of-doctors-say-they-re-burned-out-by-workload.html">here</a>. The Latest Article The article was a survey of physicians in all specialties with over 7000 respondents (unfortunately a less than 27% response rate.)(1)  Its most notable findings were: - The rate of burnout among physicians was 45.4% -  Physician specialties with higher than average rates were emergency medicine, general internal medicine, neurology, and family medicine. - The proportion of physicians who may have been depressed, (using the Primary Care Evaluation of Mental Disorders screening instrument,) was 37.8% So almost half of all physicians, and more than half of the front-line physicians who treat adults appear to be burned out, while more than one-third of physicians may be clinically depressed.  So it is not surprising that the authors called the rate of burnout "alarming."  They also commented on the implications of their data, <blockquote>Unfortunately, little evidence exists about how to address this problem. Although extensive literature suggests that contributors include excessive workload, loss of autonomy, inefficiency due to excessive administrative burdens, a decline in the sense of meaning that physicians derive from work, and difficulty integrating personal and professional life, few interventions have been tested. Most of the available literature focuses on individual interventions centered on stress reduction training rather than organizational interventions designed to address the system factors that result in high burnout rates. </blockquote>Previous Studies of Burnout and Dissatisfaction This study, in fact, is just the latest in a long series of studies showing physicians' growing angst, dissatisfaction, burnout, or whatever one calls it. In 1987, in an AMA survey of physicians over 40, 44% replied that were they given chances to do it all over again, they would not go into medicine.(2)  In a 2001 survey of Massachusetts physicians, 62.3% were dissatisfied with the practice environment.(3)  In 2002, a national survey by the Kaiser Family Foundation showed that 45% of physicians would not recommend that a young person should go into medicine.(4)   In a survey of primary care physicians in 2007, 38.7% were somewhat or very dissatisfied.(5)  I have a 6 inch thick set of paper files containing articles on the subject, although it is remarkable how many research studies reported only average scores on instruments, and hence did not report proportions of physicians who were burned out or dissatisfied. The Causes of Dissatisfaction and Burnout What is most remarkable about this voluminous literature is its relative lack of attention to the external forces and influences on physicians that are likely to be producing burnout, and the general aversion to promoting any interventions that could conceivably affect these external threats. Instead, burnout etc has been addressed as if it were some sort of psychiatric disease of physicians. This was noted above by Shanafelt et al. In fact, the reason that we did the crude qualitative literature that lead to my articles on health care dysfunction (6), and to the establishment of <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> was a general perception that physician angst was worsening (in the first few years of the 21st century), and that no one was seriously addressing its causes. Our first crude research suggested that physicians' angst was due to perceived threats to their core values, and that these threats arose from the issues this blog discusses: concentration and abuse of power, bad governance and leadership of health care organizations, and the rise of various dishonest and unethical practices that affect physicians. We have found hundreds of cases and anecdotes supporting this viewpoint. There is some corroboration of these assertions.  Some written comments from the 2001 Massachusetts survey made similar points about the causes of dissatisfaction, for example: "too much emphasis on the bottom line.  Taken over by large corporations.  Quality of care and interaction now subsumed by productivity and profit," and "the once most noble profession has become a factory job with a facade of ethics"(3)  Pololi and colleagues' qualitative interviews of young medical faculty included anecdotes of angst due to academic leaders who put revenues ahead of patient care, teaching, and research; and who allegedly used deception for personal gain.(7)  (Also, see our comments on this paper)(8)  Pololi and colleagues' large survey of US medical faculty showed that over half thought that managers were only interested in them because of the money they brought in.(9)   We were able to show in a preliminary analysis of data from a physician survey that an instrument meant to measure physicians' perception of the integrity of the leadership of their organizations, which incorporated questions about whether leaders supported core values, put patient care ahead of revenue, supported transparency about quality issues, put patient care ahead of self-interest, and displayed honesty strongly correlated (negatively) with stress, intention to leave the practice, and burnout.(10) Yet at best studies of physicians' burnout, angst, or dissatisfaction only vaguely allude to "system factors" and not greedy, money-focused, self-interested, or corrupt leadership, etc at its causes.  And again as noted above, most interventions meant to improve burnout have treated it like a psychiatric illness, not a rational response to a badly lead, dysfunctional health care system. Why Has Nothing Changed? The real question is why so little has changed given this now 20 plus year history of the documentation of burnout, and why there has been such avoidance of what appears to be the real causes of the problem. One question worth raising again at this time is why the organizations one might think would be interested in helping physicians address causes of burnout have not done so. One might think that medical societies, foundations interested in improving health and health care, bodies that accredit physicians, and academic medicine in general would all be interested in addressing the causes of physician burnout, dissatisfaction, and angst.  However, I am aware of no significant action on their part.  (There have bee some some marginal actions by the smallest of these organizations, e.g., the Society of General Internal Medicine's call to "chuck the RUC," see this <a href="http://hcrenewal.blogspot.com/2009/08/sgim-urges-chuck-ruc.html">post</a>) We should not be surprised, since most of these organizations have become more creatures of health care corporations than noble proponents of physicians' core values.  Most of these organizations have substantial institutional conflicts of interest, and are often lead by individuals with their own individual conflicts of interest.    Medical societies, in particular, now often get significant financial support from industry (pharmaceutical, biotechnology, medical device and even health insurance companies).  The societies' leaders are often full-time executives, not necessarily physicians, who may look to their industry sponsors to continue to provide the funds that support nice salaries and luxurious offices.  The society's officers and boards are often dominated by physicians with their own conflicts of interest.  (Look <a href="http://hcrenewal.blogspot.com/search/label/medical%20societies">here</a> for more examples, and see, in particular, <a href="http://hcrenewal.blogspot.com/2007/11/aaos-patient-discussion-guide-regarding.html">the case of the AAOS</a>). Similar conflicts may affect accrediting organizations, <a href="http://hcrenewal.blogspot.com/search/label/health%20care%20foundations">health care foundations</a>, and especially academic medical institutions, as we have profusely discussed.  (Look at our posts on <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a>, and <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">institutional conflicts of interest</a>.) So if physicians really want to address what is making them burned out and dissatisfied, they will have to regain control of their own societies, organizations, and academic institutions, and ensure that these organizations put core values, not revenue generation and providing cushy compensation to their executives, first.   References 1.  Shanafelt TD, Boone S, Tan et al. Burnout and satisfaction with work-life balance among US physicians relative to the general US population.  Arch Intern Med 2012; available online <a href="http://archinte.jamanetwork.com/article.aspx?articleid=1351351">here</a>. 2.    cited in Schroeder SA. The troubled profession: is medicine's glass half full or half empty? Ann Intern Med 1992; 116:583-592. 3. Massachusetts Medical Society. Physician satisfaction survey (2001). Link <a href="http://www.massmed.org/AM/PrinterTemplate.cfm?Section=Home6&TEMPLATE=/CM/ContentDisplay.cfm&CONTENTID=2504">here</a>. 4.  Kaiser Family Foundation. National survey of physicians - part III: doctors' opinions about their profession.  Link <a href="http://www.kff.org/kaiserpolls/upload/Highlights-and-Chart-Pack-2.pdf">here</a>. 5.  Merritt Hawkins & Associates. 2007 survey of primary care physicians.  Link <a href="http://www.merritthawkins.com/pdf/2007_survey_primarycare.pdf">here</a>. 6. Poses MD. A cautionary tale: the dysfunction of American health care.  Eur J Int Med 2003; 14: 123-130.  Link <a href="http://www.ejinme.com/article/S0953-6205%2803%2900029-3/abstract">here</a>. 7.Pololi L, Kern DE, Carr P, et al. The culture of academic medicine: faculty perceptions of the lack of alignment between individual and institutional values. J Gen Intern Med 2009; 24: 1289-95. Link <a href="http://www.med.upenn.edu/focus/user_documents/CultureofAcademicMedicine_Pololijgim.pdf">here.</a> 8.  Poses RM, Smith WR. Faculty values. J Gen Intern Med 2010; 25: 646. Link <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2881965/">here</a>. 9. Pololi L, Ash A, Krupat E. Faculty values in the culture of academic medicine: findings of a national faculty survey. Link <a href="https://www.aamc.org/download/154216/data/your_career_is_more_than_your_specialty_-_246.pdf">here</a>. 10.  Poses RM, Baier-Manwell L, Mundt M, Linzer M. Perceived leadership integrity and physicians’ stress, burnout, and intention to leave practice. J Gen Intern Med 2005; 20: S182.  Link <a href="http://onlinelibrary.wiley.com/doi/10.1111/jgi.2005.20.issue-S1/issuetoc">here</a>.

Will Another Study on Physician Burnout Finally Lead to Addressing its Causes?

The latest article on physician burnout has actually attracted some media attention. e.g., here and here . The Latest Article The article ...

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From the University of Chicago EHR Helpdesk Call Line

I was alerted this morning (Aug. 23rd) to this message currently in the telephone message of the CBIS [Chicago Biomedicine Information Services] Service Desk at University of Chicago Medical Center: <blockquote class="tr_bq">"Thanks for calling the CBIS Service Desk.  Your call is very important to us. We are currently experiencing troubles with our Citrix logon.  It may log you on under a different profile.  Please check before you go any further when you're logging in to Citrix."</blockquote> <a href="http://www.citrix.com/English/ps2/products/product.asp?contentID=1857200&ntref=hp_cat_prod" target="_blank">Citrix</a> is a computer program that allows remote access to information systems. I imagine the meaning of "log you on under a different profile" means "logging you on as a different user." The chances of a security breach (ability of unauthorized user to peer into patient's charts they have no business seeing), unauthorized history/order manipulation, or even misidentification error (e.g., a clinician inadvertently acting upon a patient of some other clinician who has a similar name to their own patient) and other distracting work disruptions due to the inconveniences this "trouble" creates are worrisome. One wonders how every user is being informed of this problem, as not everyone makes it a habit to call the service desk before logging in to clinical systems... But, alas, this is just a "glitch" (the <a href="http://hcrenewal.blogspot.com/2012/08/health-it-difficulties-and.html" target="_blank">euphemism used by technophiles</a> for malignant software defects), and, of course, patient safety is never compromised by "glitches." <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh6NqMEfshKCF7TC4bPKm1jza8y7xQnOiw1MNd58j6pVp85x_OBGy8hPo25yjwa79LCXObcyGT8EQOKFiThEwk3kb5ehX-JoX8QGQR8vHa2cWB2tsaUF5Eitp0DNoM8ykUgb8g87q2DrPEk/s1600/crystal+ball.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="132" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh6NqMEfshKCF7TC4bPKm1jza8y7xQnOiw1MNd58j6pVp85x_OBGy8hPo25yjwa79LCXObcyGT8EQOKFiThEwk3kb5ehX-JoX8QGQR8vHa2cWB2tsaUF5Eitp0DNoM8ykUgb8g87q2DrPEk/s200/crystal+ball.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Patient Safety Will Not Be Compromised, We Predict ... So Say Us All.</td></tr></tbody></table> -- SS 8/29/12 Addendum: Apparently the problem was finally solved between 5:30 PM and 9 PM CST on August 27.   I first became aware of it at around 8 AM EST August 23.  Brings to life the line "either you are in control of your information systems, or they are in control of you." Also, see the comment thread to this post <a href="http://www.blogger.com/comment.g?blogID=9551150&postID=3141136033860089060&isPopup=true" target="_blank">here</a>, specifically the comments starting at August 28, 2012 12:16:00 PM EDT, to see yet another demonstration of the illogic, unserious attitudes and feelings of entitlement towards patient risk and transparency characteristic of the health IT industry.  The anonymous commenter also alleges to have firsthand knowledge of the problem, suggesting they are from U. Chicago, but this cannot be confirmed. -- SS

From the University of Chicago EHR Helpdesk Call Line

I was alerted this morning (Aug. 23rd) to this message currently in the telephone message of the CBIS [Chicago Biomedicine Information Servi...

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BLOGSCAN: Key Opinion Leader Admits to being a Marketer

Without any notable shame, and <a href="http://www.kevinmd.com/blog/2012/08/doctors-key-opinion-leader-social-media.html">as a guest blogger</a> on KevinMd.  The post was about other physicians can become big-time KOLs by using social media, and refers to <a href="http://www.medcrunch.net/pharma-marketing-101-two-things-pharma-needs-from-you/">another post</a> which indicates that pharmaceutical companies look for physicians who are big prescribers of their products and have a lot of influence to, guess what, help market their products.  Although the blogger refers to ethics more than once, how it is ethical to trade on the trust physicians get for their professional vows to put patients first to market products (that may not always be good for patients) remains beyond me. ADDENDUM (27 August, 2012) - See also <a href="http://brodyhooked.blogspot.com/2012/08/you-too-can-be-kol.html">comments</a> by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

BLOGSCAN: Key Opinion Leader Admits to being a Marketer

Without any notable shame, and as a guest blogger on KevinMd. The post was about other physicians can become big-time KOLs by using social...

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An Even Bigger Golden Parachute for Captain Outrageous

In 2009, I first <a href="http://hcrenewal.blogspot.com/2009/09/captains-outrageous-for-cape-annes.html">posted</a> about the amazingly colorful leadership and governance problems at a small hospital system in Massachusetts.  Background: Northeast Health System The story of Northeast Health System then included  leaders who solicited money from the community but concealed what they were doing from the same community, an adolescent pregnancy pact after the hospital system refused to provide confidential birth control information at the high school clinic it ran, a hospital vice-president accused of art theft, various cuts, some concealed, of medical services, accusations of conflicts of interest affecting the board of trustees, and no-confidence votes by nurses and physicians. Finally, Stephen Laverty, the CEO held responsible for much of the mess, resigned and things quieted down a bit.  However, he left a system in deficit, leading to further lay-offs, (e.g., see <a href="http://www.boston.com/yourtown/salem/articles/2010/08/18/beverly_hospital_group_to_cut_jobs/">this story</a> in the Boston Globe).  And the vice-president accused of art theft was also "arraigned on bribery and larceny charges" (also <a href="http://www.boston.com/business/healthcare/articles/2010/07/23/former_hospital_official_accused_of_kickback_scheme">per the Boston Globe</a>.) Nonetheless, in 2010, it was <a href="http://hcrenewal.blogspot.com/2010/09/golden-parachute-for-captain-outrageous.html">revealed</a> that Mr Laverty left with a golden parachute worth more than $1 million.  But wait, now there is more. A Guilty Plea In May, 2012, <a href="http://www.salemnews.com/local/x1221403196/Former-hospital-VP-gets-18-months-in-jail">per the Salem News</a>, <blockquote>A former associate vice president at Beverly Hospital pleaded guilty yesterday to soliciting bribes and kickbacks from hospital contractors and stealing valuable paintings and other antiques while overseeing a $50 million renovation of the facility. Paul Galzerano, 60, was sentenced to serve 18 months of a two-year jail term on four larceny counts and two years of probation on two counts of commercial bribery during a hearing yesterday at Salem Superior Court.</blockquote> Yet More Severance Payments But wait, there is even more. Yesterday, the Gloucester Times <a href="http://www.gloucestertimes.com/local/x1088167079/Ex-hospital-CEO-Laverty-cashing-in">reported</a> about Mr Galzerano's former boss, <blockquote>Nearly four years after he resigned under fire, former Northeast Health System CEO Stephen Laverty is still collecting big paychecks from his former employer. Laverty was paid $573,348 in severance in 2011, the second year in a row he has received buyout money from Northeast, the parent nonprofit corporation to Beverly Hospital and Gloucester’s Addison Gilbert Hospital, and a corporation that was essentially merged with Lahey Clinic to become the new Lahey Health System under an agreement that gained the necessary state approvals earlier this year. </blockquote> Laverty's total severance payments have reached "more than $1.56 million over those two years." Whether the payments have ended is not clear. Attempts to discover why payments continued and became so large revealed only, <blockquote>Beverly Hospital released a statement Monday saying, 'We cannot comment on Mr. Laverty or the terms of any agreements between the company and past employees.'</blockquote>Summary For a relatively small hospital system, Northeast Health System has produced an enormous example of the perverse incentives given to top executives of health care organizations. Mr Laverty has been made a millionaire despite what the Gloucester Times called in its news article a "tenure plagued by acrimony and controversy," and leadership previously described in a Gloucester Times editorial as "arrogant, dictatorial," and a history of what only can be described as outrageous management failures. Furthermore, the money he received came not from rich stockholders, but from a struggling community hospital system. The ability of top executives of many, probably most health care organizations to collect bloated paychecks out of proportion to, if not despite their performance attracts the wrong people to lead these organizations, and provides incentives for even the right people to lead badly.  Until we make health care leaders accountable, and until their incentives reflect their ability to uphold the health care mission, expect more unaccountable leadership that subverts the health care mission, and hence continually rising costs, declining access, and deteriorating quality.

An Even Bigger Golden Parachute for Captain Outrageous

In 2009, I first posted about the amazingly colorful leadership and governance problems at a small hospital system in Massachusetts. Backg...

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Pfizer's Pforeign Pfiasco

Quelle surprise.  Giant international pharmaceutical company Pfizer managed to go for nearly 10 months without announcing a major legal settlement.  However, this month, as <a href="http://www.bloomberg.com/news/2012-08-07/pfizer-agrees-to-settle-foreign-bribery-case-with-u-s-.html">reported</a> by Bloomberg, it was time for Pfizer to settle again.  The basics were: <blockquote>Pfizer Inc., the world’s biggest drugmaker, agreed to pay $60.2 million to settle foreign bribery cases it brought to U.S. authorities involving alleged payments paid by employees and agents of subsidiaries. Pfizer entered into two agreements with the Securities and Exchange Commission and the New York-based drugmaker reached a deferred prosecution accord with the Department of Justice, according to filings today in federal court in Washington. </blockquote> Bribery This case is worth perusing because of how it documents what the US government called not merely deceptive, but corrupt practices used by Pfizer to sell drugs. The practices were widespread around the world: <blockquote>The settlements announced today include Pfizer operations in eight countries: Bulgaria, Croatia, Kazakhstan, Russia, Italy, China, the Czech Republic and Serbia. The Wyeth settlement, over its nutrition business, was for China, Indonesia, Saudi Arabia and Pakistan. </blockquote> The practices involved, not to put too fine a point on it, bribing doctors. Furthermore, as part of the settlement Pfizer apparently admitted to some of the specific practices alleged by the government: <blockquote>In Bulgaria, local representatives spent $28,000 to invite government doctors on 'incentive trips' to Greece, as a reward for the physicians who were the biggest prescribers of Pfizer’s products, Pfizer admitted according to the Justice Department filing. They also paid $17,000 to send doctors to medical conferences, again in exchange for commitments to prescribe Pfizer drugs. In Croatia, the unit there had used a consulting agreement with a government doctor to help influence which drugs were allowed to be sold in the country, paying the physician in cash and travel expenses, Pfizer admitted. Pfizer also admitted to what was called the 'hospital program,' in Russia, where doctors were given a 5 percent kick- back on certain drugs prescribed. 'Pfizer Russia used the Hospital Program to make cash payments to individual government healthcare professionals to corruptly reward past purchases and prescriptions of Pfizer products, and to corruptly induce future purchases and prescriptions,' the Justice Department said in the filing. Pfizer’s Russian unit also used intermediary companies to pay off doctors and government officials, the company admitted. </blockquote> No Individual Penalties Despite the shamefulness of these practices, as is now distressingly usual (look <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">here</a>), no individual seems to be obligated to suffer any penalty or negative consequences as a result of this settlement. While the US government alleged criminal behavior, beyond the fines imposed on the company, further prosecution will be deferred: <blockquote>The Justice Department charged the Pfizer HCP Corp. unit with two criminal counts, conspiracy to violate the Foreign Corrupt Practices Act and a violation of the FCPA’s anti-bribery provisions. Prosecutors agreed to defer prosecution and drop the charges after two years if Pfizer continues to cooperate and take remedial steps. </blockquote> The article contained a curious statement seemingly asserting that the payments were somehow made independent of any actions by individuals at Pfizer: <blockquote>The SEC said the payoffs were made 'without the knowledge or approval of officers or employees of Pfizer, but the inaccurate books and records of Pfizer subsidiaries were consolidated in the financial reports of Pfizer.' </blockquote> So were the payments made by machines acting autonomously? or by ghosts? Maybe this was just a typo. However, note that the de rigeur statement by Pfizer's internal counsel was phrased so as to imply the actions somehow occurred outside of the organization: <blockquote>'The actions which led to this resolution were disappointing, but the openness and speed with which Pfizer voluntarily disclosed and addressed them reflects our true culture and the real value we place on integrity and meeting commitments,' Amy Schulman, Pfizer’s general counsel, said in an e-mailed statement.</blockquote> Summary This latest settlement reaffirms the poor ethical culture now prevalent in major health care organizations throughout the world.  It also affirms how deeply unethical the culture has become at some of our largest and most prominent and influential health care organizations.  This settlement is only the latest evidence of ethical missteps by Pfizer's leadership. In the beginning of the 21st century, <a href="http://articles.philly.com/2009-09-03/business/25267571_1_pfizer-employee-pfizer-sales-representatives-zyvox">according to the Philadelphia Inquirer</a>, Pfizer made three major settlements, <blockquote>October 2002: Pfizer and subsidiaries Warner-Lambert and Parke-Davis agreed to pay $49 million to settle allegations that the company fraudulently avoided paying fully rebates owed to the state and federal governments under the national Medicaid Rebate program for the cholesterol-lowering drug Lipitor. May 2004: Pfizer agreed to pay $430 million to settle DOJ claims involving the off-label promotion of the epilepsy drug Neurontin by subsidiary Warner-Lambert. The promotions included flying doctors to lavish resorts and paying them hefty speakers' fees to tout the drug. The company said the activity took place years before it bought Warner-Lambert in 2000. April 2007: Pfizer agreed to pay $34.7 million in fines to settle Department of Justice allegations that it improperly promoted the human growth hormone product Genotropin. The drugmaker's Pharmacia & Upjohn Co. subsidiary pleaded guilty to offering a kickback to a pharmacy-benefits manager to sell more of the drug.</blockquote> Thereafter, Pfizer paid a $2.3 billion settlement in 2009 of civil and criminal allegations and a Pfizer subsidiary entered a guilty plea to charges it violated federal law regarding its marketing of Bextra (see post <a href="http://hcrenewal.blogspot.com/2009/09/pfour-legal-settlements-for-pfizer-why.html">here</a>).  Pfizer was involved in two other major cases from then to early 2010, including one in which a jury found the company guilty of violating the RICO (racketeer-influenced corrupt organization) statute (see post <a href="http://hcrenewal.blogspot.com/2010/03/settlement-and-conviction-round-up.html">here</a>).  The company was listed as one of the pharmaceutical "big four" companies in terms of defrauding the government (see post <a href="http://hcrenewal.blogspot.com/2010/12/drug-companies-are-now-no-1-when-it.html">here</a>).  Pfizer's Pharmacia subsidiary settled allegations that it inflated drugs costs paid by New York in early 2011 (see post <a href="http://hcrenewal.blogspot.com/2011/02/pharmacia-or-maybe-pfizer-settles-only.html">here</a>).   In March, 2011, a settlement was announced in a long-running class action case which involved allegations that another Pfizer subsidiary had exposed many people to asbestos (see <a href="http://www.bloomberg.com/news/2011-03-22/pfizer-reaches-asbestos-settlement-that-may-end-quigley-unit-s-bankruptcy.html">this story</a> in Bloomberg).  In October, 2011, Pfizer settled allegations that it illegally marketed bladder control drug Detrol (see this <a href="http://hcrenewal.blogspot.com/2011/10/what-pfizer-v-few-consequences-for-long.html">post</a>). Thus, it appears on 10 separate occasions between 2002 and 2012, Pfizer settled allegations of, pleaded guilty to, or was convicted for actions that represented seriously unethical behavior.  Note that these included a conviction that found the company to be a racketeer-influenced corrupt organization. Yet the company has not failed or been restructured, and none of its leaders has ever faced any negative consequences.  In fact, last year its CEO made over $18 million, up from over $6 million the year before (see <a href="http://hcrenewal.blogspot.com/2012/04/there-they-go-again-pfizer-ceo.html">this post</a>).    So obviously it is not just that one company's culture has become seriously corrupt.  We seem to live in such a corrupt nation, and maybe such a corrupt global society that such corrupt cultures thrive in our major corporations and organizations.  Despite stories like this in health care, just like in finance despite the global financial collapse, as Charles Ferguson said at the Oscar awards last year, " not a single ... executive has gone to jail, and that's wrong." <iframe allowfullscreen="allowfullscreen" frameborder="0" height="315" src="http://www.youtube.com/embed/mpz5DVwnbnk" width="560"></iframe> Unless we hold leaders of health care organizations accountable for bad behavior and corruption, expect bad behavior and corruption to get worse.  Until we have political leaders with the courage to stand up for honesty and the law, expect continued dishonesty and the law to continue to be trampled by the rich and powerful.

Pfizer's Pforeign Pfiasco

Quelle surprise. Giant international pharmaceutical company Pfizer managed to go for nearly 10 months without announcing a major legal sett...

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Did Joint Commission Accredit a Hospital Whose Understanding of Medication Reconciliation is Recklessly Superficial?

I submitted this complaint to the Joint Commission today. I've been challenging them in recent years (especially since my JAMA letter "<a href="http://jama.jamanetwork.com/article.aspx?articleid=184302" target="_blank">Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards</a>" on hospital executive's violation of JC Safety Standards of July 2009) over the issue of their accreditation of hospitals using bad health IT. Eventually, I hope, they will take a leadership role on health IT risk, lest they become a target for litigation.  (I think they're already there for their inaction on EHR problems despite admitted knowledge of the problems, in print, e.g., in their 2009 Sentinel Events Alert on Health IT Risks.) Here is my complaint submitted both via email and via the Joint Commission "<a href="http://www.jointcommission.org/report_a_complaint.aspx" target="_blank">Report a Complaint online</a>" page.  I added a few comments for readers in [bold red italics] that, of course, were not part of the submission: ------------------------------ Thank you for submitting your complaint!     Monday, August 20, 2012 Your complaint incident number is:     ########-######## ------------------------------ Dear Joint Commission, <div class="MsoNormal">I also sent this complaint to<a href="mailto:PSchyve@jointcommission.org" target="_blank"></a> PSchyve, AGiuntoli and MChassin via email.</div><div class="MsoNormal"> </div><div class="MsoNormal">You are already aware of the injury and death from Med Recon failure of my mother at [name redacted] Hospital, in an incident that began May 19, 2010.  Reference Incident #######-######.</div><div class="MsoNormal"> </div><div class="MsoNormal">I am also filing the issue below as a formal JC complaint:</div><div class="MsoNormal"> </div><div class="MsoNormal">As demonstrated in the sworn defense response by [name redacted] Hospital today, 8/20/12, the hospital has a very superficial understanding of Med Recon and Med Recon Failure.  </div><div class="MsoNormal"> </div><div class="MsoNormal">I am assuming they passed Joint Commission Accreditation that includes the ability to ensure continuity of care, including giving correct meds via Med Recon.</div><div class="MsoNormal"> </div><div class="MsoNormal">The hospital through defense counsel today (8/20/12) writes in a document I've placed at [URL redacted]:  <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/00235447.pdf" target="_blank"></a></div><div class="MsoNormal"> </div><blockquote class="tr_bq"><div class="MsoNormal">... 4.  As plead [sic -ed.], the <a href="http://legal-dictionary.thefreedictionary.com/gravamen" target="_blank">gravamen</a> [the basic gist of every claim or charge in a complaint - ed.] of Plaintiffs complaint is the allegation that he told the treating professionals about Mrs. Silverstein's Sotalol medication.</div><div class="MsoNormal"> </div><div class="MsoNormal">5.  Therefore, the central issue of this case is one of human communication- i.e., whether Dr. Silverstein told the various staff or not.  [In other words, their obligations to check medications end there - ed.]</div></blockquote><div class="MsoNormal"> </div><div class="MsoNormal">In fact, the complaint was quite clear:</div><div class="MsoNormal"> </div><div class="MsoNormal">...32.  The tortious conduct of defendant [name redacted] Hospital consisted of the following:</div><div class="MsoNormal"> </div><blockquote class="tr_bq"><div class="MsoNormal">a. vicarious liability for the actions of its agents [redacted], [redacted] and [redacted] to ensure continuation of the Sotalol therapy [can we all agree that's a primary responsibility of a hospital and its agents? - ed.];</div><div class="MsoNormal"> </div><div class="MsoNormal">b. vicarious liability for the actions of its agents [redacted], [redacted] and [redacted] to ensure proper operation of the defendant’s EMR system so as to ensure continuation of a presently active medication;</div><div class="MsoNormal"> </div><div class="MsoNormal">c. vicarious liability for the failure of its agents identified in this complaint to adequately communicate Ms. Silverstein’s complete medication history with the subsequent treating health care providersduring this admission;</div><div class="MsoNormal"> </div><div class="MsoNormal">d. vicarious liability for the failure of its agents, identified in this complaint, to question why no Sotalol was ordered given the noted history of arrhythmia [a medical student-level question - ed.];</div><div class="MsoNormal"> </div><div class="MsoNormal">e. failure to have in place adequate procedures or policies to insure that presently active medications are continuously active in the EMR system unless deactivated by an appropriately qualified health care provider;</div><div class="MsoNormal"> </div><div class="MsoNormal">f. failure to have in place adequate procedures or policies to insure that the computer generates appropriate alerts for others to see when critical medications become inactive;</div><div class="MsoNormal"> </div><div class="MsoNormal">g. failure to properly assess the operational effectiveness of its EMR system so as to insure that presently active medications are automatically continued unless specifically deactivated by a qualified and authorized health care provider.</div></blockquote><div class="MsoNormal"> </div><div class="MsoNormal">33. As a result of the above identified failures in medication administration and medical record charting, Ms. Silverstein has suffered the following:</div><div class="MsoNormal"> </div><blockquote class="tr_bq"><div class="MsoNormal">a. Intracranial hemorrhage; b. atrial fibrillation; c. damage to her nerves and nervous system, including memory difficulties, and seizure activity; d. brain compression due to the intracranial hemorrhage; e. requirement for additional procedures; f. prolonged hospitalizations; g. need for rehabilitation; h. need for continuous therapies; i. pain, suffering, embarrassment, humiliation, and the loss of life’s pleasures; j. death. </div></blockquote><div class="MsoNormal"> </div><div class="MsoNormal">While I gave the history of Sotalol to the clinicians on 5/19/10 (my mother had been on it dating to 2002) as I had done multiple times in this ED, this hospital seems to believe its Med Recon responsibilities end at the family - even when they have records in abundance in their paper records and EHRs (ED and floor), including from just a few weeks prior, with current med lists.</div><div class="MsoNormal"> </div><div class="MsoNormal">I note (as I had previously sent you) that Pennsylvania's Medicare QIO, Quality Insights, found the hospital had failed in medication continuity, and that the failure to administer Sotalol caused the recurrent A. fib and subsequent complications, the care not meeting professionally accepted standards. [The formal terminology for "malpractice" - ed.]</div><div class="MsoNormal"> </div><div class="MsoNormal">If you accredited this hospital, as I believe you did, this superficial understanding of Med Recon that you apparently missed or recklessly glossed over poses a serious danger to the community, and contributed materially to my mother's injuries, suffering and death.</div><div class="MsoNormal"> </div><div class="MsoNormal">Sincerely,</div><div class="MsoNormal"> </div><div class="MsoNormal">S. Silverstein, MD</div><div class="MsoNormal"> </div><div class="MsoNormal">Cc:  [attorney handling the malpractice lawsuit]</div><div class="MsoNormal"> </div><div class="MsoNormal">- end complaint -</div><div class="MsoNormal"></div><div class="MsoNormal"> --------------------</div><div class="MsoNormal"> </div><div class="MsoNormal">They defense is also trying to deflect the Judge from the issue of Metadata: <blockquote class="tr_bq">... At this point in time, it is respectfully submitted that the proposed electronic discovery is not relevant to the central issue of this case. For example, if the Triage Nurse and subsequent providers were all to testify that Dr. Silverstein never informed them that Sotalol was a current medication of Mrs, Silverstein, then the fact that medical record does not record this as a current medication has nothing to do with metadata. </blockquote> Wrong. "The fact that medical record does not record Sotalol as a current medication" after the ED encounter on 5/19/10 indicates a forensic examination of the metadata is crucial. It is in fact only through metadata that it can be determined if the medication, listed as "current" only a few weeks prior and normally visible when the user brings up a patient's record to initiate triage, was deleted by the user (e.g., via "use error" per NIST, related to bad IT design) and how and when; if it ended up in another patient's chart due to malfunction (misidentification); if the EHR malfunctioned and simply erased the med; if the chart was altered to try to hide the mistake, etc.  These are all well known failure modes.  See an example of what metadata can show <a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html" target="_blank">at this link</a> in a case that settled for over $1 million before a trial even began. In fact, over and above potentially misrepresenting my and my mother's stated medication history at ED triage: Note their attempting to deflect attention away from health IT and the med recon failure of their own staff.   Also note a reckless understanding of Medication Reconciliation, that seems to imply the hospital believes it had no duty to reconcile meds with itself, that is, check its own EHR or paper records from just a few weeks prior along with multiple others dating back 8 years, or check with the hospital-affiliated primary care and other physicians treating the patient for years, who were reachable via a simple phone call.  Instead, the issue of whether a family member told "them about the med or not" seems to be their central defense.    On the issue of who's actually responsible (and liable) for Med Recon, from the American Medical Association monograph entitled "<a href="http://www.ama-assn.org/resources/doc/cqi/med-rec-monograph.pdf" target="_blank">The physician’s role in medication reconciliation</a>", pg. 3.   <blockquote class="tr_bq">... The essence of medication reconciliation is making sense of a patient’s medications and resolving conflicts between different sources of information [paper, electronic, verbal, information from other physicians treating the patient, etc. - ed.] to minimize harm and to maximize therapeutic effects. It is an ongoing, dynamic, episodic and team-based process that should be led by and is the responsibility of the patient’s attending or personal physician in collaboration with other health care professionals. Medication reconciliation is essential to optimize the safe and effective use of medications. It is one element in the process of therapeutic use of medications and medication management for which physicians are ultimately held legally accountable. </blockquote> The AMA monograph has a special section starting on p. 20 on IT and Med Recon.  It warns explicitly about practicing medicine like a mindless robot: <blockquote class="tr_bq">... IT systems and applications do have the potential to streamline the medication reconciliation process—especially assembling and storing patient information—and to provide the means to effectively transfer patient medication information across the continuum of care. However, health care technology is fragmented and requires close attention by potential users to ensure that implementation does not create additional pressures and problems with accuracy of medications.</blockquote> The apparent hospital misunderstanding of Med Recon could - and in my view, should - result in charges of gross negligence, perhaps criminal, against its medical leadership if other patients have been, or are, harmed as a result of resultant medication reconciliation errors. Of course, it's also possible that the defense is <a href="http://hcrenewal.blogspot.com/2012/08/defense-attorney-lies-under-oath-to.html" target="_blank">just making stuff up again</a> to try to blow smoke up the judge's behind.  However, what's sworn certainly should not be lightly dismissed.  I also note that this hospital is making a spectacle of itself in front of the Judge, the President Judge in the county where it conducts operations, who already dismissed a boatload of meritless claims.  That does not bode well for them in the future. </div><div class="MsoNormal"> </div><div class="MsoNormal">-- SS</div>

Did Joint Commission Accredit a Hospital Whose Understanding of Medication Reconciliation is Recklessly Superficial?

I submitted this complaint to the Joint Commission today. I've been challenging them in recent years (especially since my JAMA letter ...

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